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Dissemination of a Care Collaboration Project
"I always pray that my patient won’t need supplies, like oxygen, because that means dealing with the VA. It’s impossible.”
Similar sentiments are shared by community health care providers (HCPs) when addressing the needs of their dual-care patients; those veterans who receive care from both the VHA and non-VHA providers and health care organizations.1,2 Many Medicare-eligible VHA primary care patients access primary and specialty care outside of VHA.3-6
Related: Treating Dual-Use Patients Across Two Health Care Systems
The consequences of dual care for veteran patients have been well described in the literature. Dual-care patients are at risk for several suboptimal health outcomes (higher A1c values, dying of colon cancer, rehospitalization for recurrent stroke or for any other cause),7-11 which may result from receiving fragmented or duplicative care.3,12
Much less attention has been paid to the interactions and care processes that occur between VHA providers and their community counterparts. Many community HCPs experience confusion and frustration when trying to coordinate patient care with VHA and are, not surprisingly, unfamiliar with VHA goals, policies, and procedures.
A study that explored perceptions of nonfederal physicians regarding barriers to effective dual care for veterans showed that coordinating care with VHA is often considered difficult.13 Most study respondents indicated that they were rarely or never informed about the visits that the patient makes to the VHA. There was the perception that information sharing is more common from non-VHA to VHA than vice versa. Most respondents indicated that they were unable to access the VHA formulary, making prescribing medications for their veteran patients problematic. More than half noted that the patient transfer to a VHA facility was problematic.
Related: Veterans' Health and Opioid Safety—Contexts, Risks, and Outreach Implications
Similar difficulties were experienced at the White River Junction VAMC (WRJVAMC) in Vermont. In hopes of alleviating the problems, a pilot project was conducted. The project provided information sharing and discussion meetings for community organizations often involved in dual care. As the project progressed, the VHA case managers observed that community nurses were more likely to have relevant data needed to transfer patients to a VA hospital. Meeting attendees expressed a desire to have greater communication and collaboration with VA. The WRJVAMC leadership recognized the positive impact of this pilot project on community engagement. An expanded trial was proposed and funded by the VHA Office of Rural Health (ORH).
The current project began in 2009 and is conducted throughout VISN 1, which encompasses all the New England states and includes 8 VAMCs and 47 additional access points, including community-based outpatient clinics (CBOCs) and outreach clinics. It is hoped that the project can create an organizational culture change in which VHA facilities move from a dual care to a comanaged care perspective. Presentations are made to community HCPs and staff who may provide care to veterans also served by VHA. The presentations explain the processes for delivery of VHA care; the history and mission of the VHA; eligibility for VHA health care; obtaining VHA prescriptions, medical supplies, and medical records; and transferring a patient to a VHA hospital. Presentations also include adequate time for conversation and questions.
The project lead is the director of primary care for VISN 1, and teams of local champions were assembled at each of the 8 medical centers. To facilitate recruitment of project staff, interested individuals attended a kick-off meeting held at a central location. Attendees heard a presentation about the consequences of dual care and spent time in a facilitated brainstorming session regarding the difficulties of comanaging care with community hospitals, providers, and health care organizations. The immediate overarching goal to “be good neighbors” to community partners was discussed. Finally, the expectations of project participation were considered, and questions were answered.
Following the in-person meeting, telephone calls were arranged with each site team to answer any remaining questions and secure participation. The majority of teams were composed of 1 primary care physician and 1 nurse/nurse case manager. The VISN 1 team was aided by staff from the ORH Veterans Rural Health Resource Center-Eastern Region (VRHRC-ER) to support project planning, implementation, and evaluation.
Related: Perceived Attitudes and Staff Roles of Disaster Management at CBOCs
The presentations were developed by the core project team members and the local VAMC project champions. The initial presentations targeted community physicians and primary care providers (PCPs). These short 30- to 60-minute presentations were designed to fit within lunch breaks and staff meetings. Along with the short presentations, longer (up to 3-4 hours), in-depth presentations targeted to medical staff (nurse case managers, social workers, financial/billing personnel) were scheduled through fiscal years (FYs) 2014-2015. These in-depth presentations will continue in FY16.
A 4-step protocol, outlined by Tomioka and colleagues, was chosen to guide dissemination activities and allow for evaluation of the degree of fidelity to the project model on replication.14 The steps begin with identifying the components of the program and advance through determining implementation and evaluating the degree of fidelity at the new site. Described here is the application of step 1 of the protocol. The second component is under way, and all remaining steps will be reported in a future article.
Methods
Through a series of focused discussions, the core project team delineated the specific project components. Each team member independently assigned an Adaptation Traffic Light designation to each component. Red light changes were those elements that cannot be altered without negatively impacting fidelity to the project model. Yellow light changes can be undertaken with caution, as they could potentially result in substantial deviations from the original project model. Finally, green light changes can be made without negative impact on the program.14 The team reconvened, discussed rationales for the assignments, reevaluated the values assigned, and reached an agreement about the light designation for each component. In cases where an agreement could not be reached through discussion, the team reexamined the component and made changes to the definition where warranted. For example, a concept that had been defined too broadly was broken down further until an agreement was reached regarding categorization of the resultant parts.
Results and Discussion
The project components, how they were implemented, and the Adaptation Traffic Light designations are presented in Table 1. This exercise brought clarity and focus to how the core project team viewed the implementation activities.
Red Lights
Several staff roles and project components were identified that were considered essential to success. First on this list was the role of the leader-champion. To have full impact, the leader-champion must be in a position of authority. For this project, the role of leader-champion was filled by the VISN 1 Primary Care Service Line director. The leader-champion actively facilitated weekly meetings, acted as a project ambassador to VA leadership, and expressed an even-tempered, supportive, problem-solving perspective with the various medical center project leads.
Because this project is implemented across a wide geographic area, local champions at each VAMC were deemed a red-light component. Having motivated people “on the ground” who are invested in the project’s goals is essential for success. For optimal outcomes, local champion involvement must be a choice and not an additional assigned responsibility. Maintaining a stable project team is ideal. In the instances where VAMC teams lost members, the core project team would actively assist in finding new members and orienting new members to the project.
An experienced project manager was also thought to be a red-light element for successful implementation. The project manager must maintain project focus, momentum, and trajectory while identifying opportunities for improvement and expansion.
This project could not be successfully implemented without dedicated administrative support and therefore could not be replicated without administrative assistance. Administrative support for this project was provided by 2 individuals. One individual maintained the weekly meeting schedule, arranged in-person team meetings, produced and circulated meeting minutes, and maintained a calendar of presentations. The second individual provided logistic support to ensure that project funds, equipment, and materials were accessible to each local medical center team as needed.
Community attendees were also a red-light component. On project initiation, the study team intended physicians and midlevel PCPs to be the target audience. However, many physicians were unable to attend due to time constraints. Instead, nurses and other office staff attended—only 13% of the attendees identified themselves as physicians or midlevel providers. As a result, the large project team decided to shift the initial focus from targeting providers to a the broader complement of HCPs. Work began to develop a more in-depth presentation, which would be of interest to nurses, case managers, social workers, administrators, and other medical office personnel.
Presentation content must be consistent across the sites and was, therefore, a red-light element. It is vitally important that the core message being delivered is unified. A small number of slides in the presentation were edited locally to include information specific to the individual medical center (clinic locations, addresses, telephone numbers, and local processes), but the majority of slides had identical content and formatting. The slide set is available on request.
Yellow Lights
Three project components were thought to have yellow-light flexibility and could, when changed with caution, allow for dissemination with fidelity to the project model. The printed materials distributed at presentations included booklets, trifold brochures, information sheets, and other resources seen as useful by each medical center team. Any printed materials could be distributed as long as they were VHA vetted and approved.
Although the evaluation is an essential component to tracking project impact and should be carried out in some form, it is recognized that not all facilities will need or want to conduct such a structured and time-intensive evaluation. In this case, evaluation included before-and-after presentation feedback forms and a telephone call 3 to 6 months after attendance.
Immediately following the presentation, participants were asked to rerate their VA-specific knowledge and identify the presentation elements they found most important. At the 3-month follow-up call, attendees were asked to give feedback about any situations in which they had comanaged care with VA, explain how any interactions had gone, and discuss whether they used any of the printed handouts. As of February 28, 2015, 101 presentations were made to more than 1,700 individuals. A total of 1,183 feedback forms (598 before and 585 after) were returned. The results showed a dramatic increase in self-rated knowledge of VA-specific topics and procedures (Table 2). Open-ended comments articulated appreciation for the VA teams’ willingness to openly share information, respectfully hear concerns from the community, and proactively work to improve care for veteran patients.
Presentation demeanor is very important but has some flexibility. The presenter does not have to be a seasoned public speaker. However, the presenter should adopt an unassuming, genuine, open stance and be willing to hear comments and criticisms in a gracious way. In those cases where a participant shares a bad experience in dealing with VA, the presenter must assure the speaker that the intention is to improve collaboration.
Green Lights
Event scheduling and identification of potential presentation sites was largely left up to the local VAMC and CBOC teams. Methods included contacting nearby health care facilities, leveraging existing professional and personal relationships, and targeting community facilities that were known to treat veterans. The status of presentations was reviewed at each team meeting. Finding the time to schedule and arrange presentations was difficult for many of the teams. The core project team enlisted the help of the Geospatial Outcomes Division at the Malcom Randall VAMC in Gainesville, Florida, to use geographic information system technology to create a list of facilities in the area of each VAMC. This allowed the teams to further target potential attendees.
Various other tasks were still noteworthy in their significance to the project’s success in VISN 1. The VISN 1 Care Collaboration project required portable projectors for each team. Funds for the projectors were sent to each participating facility to procure the projector locally. Salary support funding was sent to each participating VAMC to allow overtime as needed for presentations. Funding was also sent to each medical center to cover travel expenses related to project activities. Printing of presentation booklets was handled centrally, using the GPOExpress program, which allows printing at any FedEx office location and provides deep discounts for printed products. The ability to print on demand to a remote location with very short turnaround times was crucial in many instances.
Conculsions
This project began as a pilot implemented at a single medical center in 2009 and grew into a VISN-wide initiative. After expansion, all 8 VISN 1 sites, the core project team was able to have substantive discussions about the project’s components, their relative importance in the dissemination process, and suggestions for alternatives to identified barriers.14
In FY15, the VISN 1 core project team has helped expand the project in VISN 19. The new project team, located at the Salt Lake City VAMC in Utah, has long been interested in improving communication and collaboration with the non-VA health care community. However, interest and enthusiasm alone are not sufficient for successful uptake. Many sites likely will not have special funding to implement this program.
As a tool to support successful implementation, essential implementation components were identified, based on experience. Local facilities can use the information included in Table 1 to consider and assess their assets, identify enthusiastic staff in their facility, consider creative local partnerships that would support implementation, and reach out to local rural health resources for assistance. Efforts to build collegial relationships with community providers will enhance communication and improve the quality of care received by all veterans.
Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.
Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.
1. Borowsky SJ, Cowper DC. Dual use of VA and non-VA primary care. J Gen Intern Med. 1999;14(5): 274-280.
2. Nayar P, Nguyen AT, Ojha D, Schmid KK, Apenteng B, Woodbridge P. Transitions in dual care for veterans: non-federal physician perspectives. J Community Health. 2013;38(2):225-237.
3. Liu CF, Bryson CL, Burgess JF Jr, Sharp N, Perkins M, Maciejewski ML. Use of outpatient care in VA and Medicare among disability-eligible and age-eligible veteran patients. BMC Health Serv Res. 2012;12:51.
4. Liu CF, Chapko M, Bryson CL, et al. Use of outpatient care in Veterans Health Administration and Medicare among veterans receiving primary care in community-based and hospital outpatient clinics. Health Serv Res. 2010;45(5, pt 1):1268-1286.
5. Lee PW, Markle PS, West AN, Lee RE. Use and quality of care at a VA outreach clinic in northern Maine. J Prim Care Community Health. 2012;3(3):159-163.
6. Petersen LA, Byrne MM, Daw CN, Hasche J, Reis B, Pietz K. Relationship between clinical conditions and use of Veterans Affairs health care among Medicare-enrolled veterans. Health Serv Res. 2010;45(3):762-791.
7. Helmer D, Sambamoorthi U, Shen Y, et al. Opting out of an integrated healthcare system: dual-system use is associated with poorer glycemic control in veterans with diabetes. Prim Care Diabetes. 2008;2(2):73-80.
8. Tarlov E, Lee TA, Weichle TW, et al. Reduced overall and event-free survival among colon cancer patients using dual system care. Cancer Epidemiol Biomarkers Prev. 2012;21(12):2231-2241.
9. Wolinsky FD, An H, Liu L, Miller TR, Rosenthal GE. Exploring the association of dual use of the VHA and Medicare with mortality: separating the contributions of inpatient and outpatient services. BMC Health Serv Res. 2007;7:70.
10. Wolinsky FD, Miller TR, An H, Brezinski PR, Vaughn TE, Rosenthal GE. Dual use of Medicare and the Veterans Health Administration: are there adverse health outcomes? BMC Health Serv Res. 2006;6:131.
11. Jia H, Zheng Y, Reker DM, et al. Multiple system utilization and mortality for veterans with stroke. Stroke. 2007;38(2):355-360.
12. Maciejewski ML, Wang V, Burgess JF Jr, Bryson CL, Perkins M, Liu CF. The continuity and quality of primary care. Med Care Res Rev. 2013;70(5):497-513.
13. Miller EA, Intrator O. Veterans use of non-VHA services: implications for policy and planning. Soc Work Public Health. 2012;27(4):379-391.
14. Tomioka M, Braun KL. Implementing evidence-based programs: a four-step protocol for assuring replication with fidelity. Health Promot Pract. 2013;14(6):850-858.
"I always pray that my patient won’t need supplies, like oxygen, because that means dealing with the VA. It’s impossible.”
Similar sentiments are shared by community health care providers (HCPs) when addressing the needs of their dual-care patients; those veterans who receive care from both the VHA and non-VHA providers and health care organizations.1,2 Many Medicare-eligible VHA primary care patients access primary and specialty care outside of VHA.3-6
Related: Treating Dual-Use Patients Across Two Health Care Systems
The consequences of dual care for veteran patients have been well described in the literature. Dual-care patients are at risk for several suboptimal health outcomes (higher A1c values, dying of colon cancer, rehospitalization for recurrent stroke or for any other cause),7-11 which may result from receiving fragmented or duplicative care.3,12
Much less attention has been paid to the interactions and care processes that occur between VHA providers and their community counterparts. Many community HCPs experience confusion and frustration when trying to coordinate patient care with VHA and are, not surprisingly, unfamiliar with VHA goals, policies, and procedures.
A study that explored perceptions of nonfederal physicians regarding barriers to effective dual care for veterans showed that coordinating care with VHA is often considered difficult.13 Most study respondents indicated that they were rarely or never informed about the visits that the patient makes to the VHA. There was the perception that information sharing is more common from non-VHA to VHA than vice versa. Most respondents indicated that they were unable to access the VHA formulary, making prescribing medications for their veteran patients problematic. More than half noted that the patient transfer to a VHA facility was problematic.
Related: Veterans' Health and Opioid Safety—Contexts, Risks, and Outreach Implications
Similar difficulties were experienced at the White River Junction VAMC (WRJVAMC) in Vermont. In hopes of alleviating the problems, a pilot project was conducted. The project provided information sharing and discussion meetings for community organizations often involved in dual care. As the project progressed, the VHA case managers observed that community nurses were more likely to have relevant data needed to transfer patients to a VA hospital. Meeting attendees expressed a desire to have greater communication and collaboration with VA. The WRJVAMC leadership recognized the positive impact of this pilot project on community engagement. An expanded trial was proposed and funded by the VHA Office of Rural Health (ORH).
The current project began in 2009 and is conducted throughout VISN 1, which encompasses all the New England states and includes 8 VAMCs and 47 additional access points, including community-based outpatient clinics (CBOCs) and outreach clinics. It is hoped that the project can create an organizational culture change in which VHA facilities move from a dual care to a comanaged care perspective. Presentations are made to community HCPs and staff who may provide care to veterans also served by VHA. The presentations explain the processes for delivery of VHA care; the history and mission of the VHA; eligibility for VHA health care; obtaining VHA prescriptions, medical supplies, and medical records; and transferring a patient to a VHA hospital. Presentations also include adequate time for conversation and questions.
The project lead is the director of primary care for VISN 1, and teams of local champions were assembled at each of the 8 medical centers. To facilitate recruitment of project staff, interested individuals attended a kick-off meeting held at a central location. Attendees heard a presentation about the consequences of dual care and spent time in a facilitated brainstorming session regarding the difficulties of comanaging care with community hospitals, providers, and health care organizations. The immediate overarching goal to “be good neighbors” to community partners was discussed. Finally, the expectations of project participation were considered, and questions were answered.
Following the in-person meeting, telephone calls were arranged with each site team to answer any remaining questions and secure participation. The majority of teams were composed of 1 primary care physician and 1 nurse/nurse case manager. The VISN 1 team was aided by staff from the ORH Veterans Rural Health Resource Center-Eastern Region (VRHRC-ER) to support project planning, implementation, and evaluation.
Related: Perceived Attitudes and Staff Roles of Disaster Management at CBOCs
The presentations were developed by the core project team members and the local VAMC project champions. The initial presentations targeted community physicians and primary care providers (PCPs). These short 30- to 60-minute presentations were designed to fit within lunch breaks and staff meetings. Along with the short presentations, longer (up to 3-4 hours), in-depth presentations targeted to medical staff (nurse case managers, social workers, financial/billing personnel) were scheduled through fiscal years (FYs) 2014-2015. These in-depth presentations will continue in FY16.
A 4-step protocol, outlined by Tomioka and colleagues, was chosen to guide dissemination activities and allow for evaluation of the degree of fidelity to the project model on replication.14 The steps begin with identifying the components of the program and advance through determining implementation and evaluating the degree of fidelity at the new site. Described here is the application of step 1 of the protocol. The second component is under way, and all remaining steps will be reported in a future article.
Methods
Through a series of focused discussions, the core project team delineated the specific project components. Each team member independently assigned an Adaptation Traffic Light designation to each component. Red light changes were those elements that cannot be altered without negatively impacting fidelity to the project model. Yellow light changes can be undertaken with caution, as they could potentially result in substantial deviations from the original project model. Finally, green light changes can be made without negative impact on the program.14 The team reconvened, discussed rationales for the assignments, reevaluated the values assigned, and reached an agreement about the light designation for each component. In cases where an agreement could not be reached through discussion, the team reexamined the component and made changes to the definition where warranted. For example, a concept that had been defined too broadly was broken down further until an agreement was reached regarding categorization of the resultant parts.
Results and Discussion
The project components, how they were implemented, and the Adaptation Traffic Light designations are presented in Table 1. This exercise brought clarity and focus to how the core project team viewed the implementation activities.
Red Lights
Several staff roles and project components were identified that were considered essential to success. First on this list was the role of the leader-champion. To have full impact, the leader-champion must be in a position of authority. For this project, the role of leader-champion was filled by the VISN 1 Primary Care Service Line director. The leader-champion actively facilitated weekly meetings, acted as a project ambassador to VA leadership, and expressed an even-tempered, supportive, problem-solving perspective with the various medical center project leads.
Because this project is implemented across a wide geographic area, local champions at each VAMC were deemed a red-light component. Having motivated people “on the ground” who are invested in the project’s goals is essential for success. For optimal outcomes, local champion involvement must be a choice and not an additional assigned responsibility. Maintaining a stable project team is ideal. In the instances where VAMC teams lost members, the core project team would actively assist in finding new members and orienting new members to the project.
An experienced project manager was also thought to be a red-light element for successful implementation. The project manager must maintain project focus, momentum, and trajectory while identifying opportunities for improvement and expansion.
This project could not be successfully implemented without dedicated administrative support and therefore could not be replicated without administrative assistance. Administrative support for this project was provided by 2 individuals. One individual maintained the weekly meeting schedule, arranged in-person team meetings, produced and circulated meeting minutes, and maintained a calendar of presentations. The second individual provided logistic support to ensure that project funds, equipment, and materials were accessible to each local medical center team as needed.
Community attendees were also a red-light component. On project initiation, the study team intended physicians and midlevel PCPs to be the target audience. However, many physicians were unable to attend due to time constraints. Instead, nurses and other office staff attended—only 13% of the attendees identified themselves as physicians or midlevel providers. As a result, the large project team decided to shift the initial focus from targeting providers to a the broader complement of HCPs. Work began to develop a more in-depth presentation, which would be of interest to nurses, case managers, social workers, administrators, and other medical office personnel.
Presentation content must be consistent across the sites and was, therefore, a red-light element. It is vitally important that the core message being delivered is unified. A small number of slides in the presentation were edited locally to include information specific to the individual medical center (clinic locations, addresses, telephone numbers, and local processes), but the majority of slides had identical content and formatting. The slide set is available on request.
Yellow Lights
Three project components were thought to have yellow-light flexibility and could, when changed with caution, allow for dissemination with fidelity to the project model. The printed materials distributed at presentations included booklets, trifold brochures, information sheets, and other resources seen as useful by each medical center team. Any printed materials could be distributed as long as they were VHA vetted and approved.
Although the evaluation is an essential component to tracking project impact and should be carried out in some form, it is recognized that not all facilities will need or want to conduct such a structured and time-intensive evaluation. In this case, evaluation included before-and-after presentation feedback forms and a telephone call 3 to 6 months after attendance.
Immediately following the presentation, participants were asked to rerate their VA-specific knowledge and identify the presentation elements they found most important. At the 3-month follow-up call, attendees were asked to give feedback about any situations in which they had comanaged care with VA, explain how any interactions had gone, and discuss whether they used any of the printed handouts. As of February 28, 2015, 101 presentations were made to more than 1,700 individuals. A total of 1,183 feedback forms (598 before and 585 after) were returned. The results showed a dramatic increase in self-rated knowledge of VA-specific topics and procedures (Table 2). Open-ended comments articulated appreciation for the VA teams’ willingness to openly share information, respectfully hear concerns from the community, and proactively work to improve care for veteran patients.
Presentation demeanor is very important but has some flexibility. The presenter does not have to be a seasoned public speaker. However, the presenter should adopt an unassuming, genuine, open stance and be willing to hear comments and criticisms in a gracious way. In those cases where a participant shares a bad experience in dealing with VA, the presenter must assure the speaker that the intention is to improve collaboration.
Green Lights
Event scheduling and identification of potential presentation sites was largely left up to the local VAMC and CBOC teams. Methods included contacting nearby health care facilities, leveraging existing professional and personal relationships, and targeting community facilities that were known to treat veterans. The status of presentations was reviewed at each team meeting. Finding the time to schedule and arrange presentations was difficult for many of the teams. The core project team enlisted the help of the Geospatial Outcomes Division at the Malcom Randall VAMC in Gainesville, Florida, to use geographic information system technology to create a list of facilities in the area of each VAMC. This allowed the teams to further target potential attendees.
Various other tasks were still noteworthy in their significance to the project’s success in VISN 1. The VISN 1 Care Collaboration project required portable projectors for each team. Funds for the projectors were sent to each participating facility to procure the projector locally. Salary support funding was sent to each participating VAMC to allow overtime as needed for presentations. Funding was also sent to each medical center to cover travel expenses related to project activities. Printing of presentation booklets was handled centrally, using the GPOExpress program, which allows printing at any FedEx office location and provides deep discounts for printed products. The ability to print on demand to a remote location with very short turnaround times was crucial in many instances.
Conculsions
This project began as a pilot implemented at a single medical center in 2009 and grew into a VISN-wide initiative. After expansion, all 8 VISN 1 sites, the core project team was able to have substantive discussions about the project’s components, their relative importance in the dissemination process, and suggestions for alternatives to identified barriers.14
In FY15, the VISN 1 core project team has helped expand the project in VISN 19. The new project team, located at the Salt Lake City VAMC in Utah, has long been interested in improving communication and collaboration with the non-VA health care community. However, interest and enthusiasm alone are not sufficient for successful uptake. Many sites likely will not have special funding to implement this program.
As a tool to support successful implementation, essential implementation components were identified, based on experience. Local facilities can use the information included in Table 1 to consider and assess their assets, identify enthusiastic staff in their facility, consider creative local partnerships that would support implementation, and reach out to local rural health resources for assistance. Efforts to build collegial relationships with community providers will enhance communication and improve the quality of care received by all veterans.
Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.
Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.
"I always pray that my patient won’t need supplies, like oxygen, because that means dealing with the VA. It’s impossible.”
Similar sentiments are shared by community health care providers (HCPs) when addressing the needs of their dual-care patients; those veterans who receive care from both the VHA and non-VHA providers and health care organizations.1,2 Many Medicare-eligible VHA primary care patients access primary and specialty care outside of VHA.3-6
Related: Treating Dual-Use Patients Across Two Health Care Systems
The consequences of dual care for veteran patients have been well described in the literature. Dual-care patients are at risk for several suboptimal health outcomes (higher A1c values, dying of colon cancer, rehospitalization for recurrent stroke or for any other cause),7-11 which may result from receiving fragmented or duplicative care.3,12
Much less attention has been paid to the interactions and care processes that occur between VHA providers and their community counterparts. Many community HCPs experience confusion and frustration when trying to coordinate patient care with VHA and are, not surprisingly, unfamiliar with VHA goals, policies, and procedures.
A study that explored perceptions of nonfederal physicians regarding barriers to effective dual care for veterans showed that coordinating care with VHA is often considered difficult.13 Most study respondents indicated that they were rarely or never informed about the visits that the patient makes to the VHA. There was the perception that information sharing is more common from non-VHA to VHA than vice versa. Most respondents indicated that they were unable to access the VHA formulary, making prescribing medications for their veteran patients problematic. More than half noted that the patient transfer to a VHA facility was problematic.
Related: Veterans' Health and Opioid Safety—Contexts, Risks, and Outreach Implications
Similar difficulties were experienced at the White River Junction VAMC (WRJVAMC) in Vermont. In hopes of alleviating the problems, a pilot project was conducted. The project provided information sharing and discussion meetings for community organizations often involved in dual care. As the project progressed, the VHA case managers observed that community nurses were more likely to have relevant data needed to transfer patients to a VA hospital. Meeting attendees expressed a desire to have greater communication and collaboration with VA. The WRJVAMC leadership recognized the positive impact of this pilot project on community engagement. An expanded trial was proposed and funded by the VHA Office of Rural Health (ORH).
The current project began in 2009 and is conducted throughout VISN 1, which encompasses all the New England states and includes 8 VAMCs and 47 additional access points, including community-based outpatient clinics (CBOCs) and outreach clinics. It is hoped that the project can create an organizational culture change in which VHA facilities move from a dual care to a comanaged care perspective. Presentations are made to community HCPs and staff who may provide care to veterans also served by VHA. The presentations explain the processes for delivery of VHA care; the history and mission of the VHA; eligibility for VHA health care; obtaining VHA prescriptions, medical supplies, and medical records; and transferring a patient to a VHA hospital. Presentations also include adequate time for conversation and questions.
The project lead is the director of primary care for VISN 1, and teams of local champions were assembled at each of the 8 medical centers. To facilitate recruitment of project staff, interested individuals attended a kick-off meeting held at a central location. Attendees heard a presentation about the consequences of dual care and spent time in a facilitated brainstorming session regarding the difficulties of comanaging care with community hospitals, providers, and health care organizations. The immediate overarching goal to “be good neighbors” to community partners was discussed. Finally, the expectations of project participation were considered, and questions were answered.
Following the in-person meeting, telephone calls were arranged with each site team to answer any remaining questions and secure participation. The majority of teams were composed of 1 primary care physician and 1 nurse/nurse case manager. The VISN 1 team was aided by staff from the ORH Veterans Rural Health Resource Center-Eastern Region (VRHRC-ER) to support project planning, implementation, and evaluation.
Related: Perceived Attitudes and Staff Roles of Disaster Management at CBOCs
The presentations were developed by the core project team members and the local VAMC project champions. The initial presentations targeted community physicians and primary care providers (PCPs). These short 30- to 60-minute presentations were designed to fit within lunch breaks and staff meetings. Along with the short presentations, longer (up to 3-4 hours), in-depth presentations targeted to medical staff (nurse case managers, social workers, financial/billing personnel) were scheduled through fiscal years (FYs) 2014-2015. These in-depth presentations will continue in FY16.
A 4-step protocol, outlined by Tomioka and colleagues, was chosen to guide dissemination activities and allow for evaluation of the degree of fidelity to the project model on replication.14 The steps begin with identifying the components of the program and advance through determining implementation and evaluating the degree of fidelity at the new site. Described here is the application of step 1 of the protocol. The second component is under way, and all remaining steps will be reported in a future article.
Methods
Through a series of focused discussions, the core project team delineated the specific project components. Each team member independently assigned an Adaptation Traffic Light designation to each component. Red light changes were those elements that cannot be altered without negatively impacting fidelity to the project model. Yellow light changes can be undertaken with caution, as they could potentially result in substantial deviations from the original project model. Finally, green light changes can be made without negative impact on the program.14 The team reconvened, discussed rationales for the assignments, reevaluated the values assigned, and reached an agreement about the light designation for each component. In cases where an agreement could not be reached through discussion, the team reexamined the component and made changes to the definition where warranted. For example, a concept that had been defined too broadly was broken down further until an agreement was reached regarding categorization of the resultant parts.
Results and Discussion
The project components, how they were implemented, and the Adaptation Traffic Light designations are presented in Table 1. This exercise brought clarity and focus to how the core project team viewed the implementation activities.
Red Lights
Several staff roles and project components were identified that were considered essential to success. First on this list was the role of the leader-champion. To have full impact, the leader-champion must be in a position of authority. For this project, the role of leader-champion was filled by the VISN 1 Primary Care Service Line director. The leader-champion actively facilitated weekly meetings, acted as a project ambassador to VA leadership, and expressed an even-tempered, supportive, problem-solving perspective with the various medical center project leads.
Because this project is implemented across a wide geographic area, local champions at each VAMC were deemed a red-light component. Having motivated people “on the ground” who are invested in the project’s goals is essential for success. For optimal outcomes, local champion involvement must be a choice and not an additional assigned responsibility. Maintaining a stable project team is ideal. In the instances where VAMC teams lost members, the core project team would actively assist in finding new members and orienting new members to the project.
An experienced project manager was also thought to be a red-light element for successful implementation. The project manager must maintain project focus, momentum, and trajectory while identifying opportunities for improvement and expansion.
This project could not be successfully implemented without dedicated administrative support and therefore could not be replicated without administrative assistance. Administrative support for this project was provided by 2 individuals. One individual maintained the weekly meeting schedule, arranged in-person team meetings, produced and circulated meeting minutes, and maintained a calendar of presentations. The second individual provided logistic support to ensure that project funds, equipment, and materials were accessible to each local medical center team as needed.
Community attendees were also a red-light component. On project initiation, the study team intended physicians and midlevel PCPs to be the target audience. However, many physicians were unable to attend due to time constraints. Instead, nurses and other office staff attended—only 13% of the attendees identified themselves as physicians or midlevel providers. As a result, the large project team decided to shift the initial focus from targeting providers to a the broader complement of HCPs. Work began to develop a more in-depth presentation, which would be of interest to nurses, case managers, social workers, administrators, and other medical office personnel.
Presentation content must be consistent across the sites and was, therefore, a red-light element. It is vitally important that the core message being delivered is unified. A small number of slides in the presentation were edited locally to include information specific to the individual medical center (clinic locations, addresses, telephone numbers, and local processes), but the majority of slides had identical content and formatting. The slide set is available on request.
Yellow Lights
Three project components were thought to have yellow-light flexibility and could, when changed with caution, allow for dissemination with fidelity to the project model. The printed materials distributed at presentations included booklets, trifold brochures, information sheets, and other resources seen as useful by each medical center team. Any printed materials could be distributed as long as they were VHA vetted and approved.
Although the evaluation is an essential component to tracking project impact and should be carried out in some form, it is recognized that not all facilities will need or want to conduct such a structured and time-intensive evaluation. In this case, evaluation included before-and-after presentation feedback forms and a telephone call 3 to 6 months after attendance.
Immediately following the presentation, participants were asked to rerate their VA-specific knowledge and identify the presentation elements they found most important. At the 3-month follow-up call, attendees were asked to give feedback about any situations in which they had comanaged care with VA, explain how any interactions had gone, and discuss whether they used any of the printed handouts. As of February 28, 2015, 101 presentations were made to more than 1,700 individuals. A total of 1,183 feedback forms (598 before and 585 after) were returned. The results showed a dramatic increase in self-rated knowledge of VA-specific topics and procedures (Table 2). Open-ended comments articulated appreciation for the VA teams’ willingness to openly share information, respectfully hear concerns from the community, and proactively work to improve care for veteran patients.
Presentation demeanor is very important but has some flexibility. The presenter does not have to be a seasoned public speaker. However, the presenter should adopt an unassuming, genuine, open stance and be willing to hear comments and criticisms in a gracious way. In those cases where a participant shares a bad experience in dealing with VA, the presenter must assure the speaker that the intention is to improve collaboration.
Green Lights
Event scheduling and identification of potential presentation sites was largely left up to the local VAMC and CBOC teams. Methods included contacting nearby health care facilities, leveraging existing professional and personal relationships, and targeting community facilities that were known to treat veterans. The status of presentations was reviewed at each team meeting. Finding the time to schedule and arrange presentations was difficult for many of the teams. The core project team enlisted the help of the Geospatial Outcomes Division at the Malcom Randall VAMC in Gainesville, Florida, to use geographic information system technology to create a list of facilities in the area of each VAMC. This allowed the teams to further target potential attendees.
Various other tasks were still noteworthy in their significance to the project’s success in VISN 1. The VISN 1 Care Collaboration project required portable projectors for each team. Funds for the projectors were sent to each participating facility to procure the projector locally. Salary support funding was sent to each participating VAMC to allow overtime as needed for presentations. Funding was also sent to each medical center to cover travel expenses related to project activities. Printing of presentation booklets was handled centrally, using the GPOExpress program, which allows printing at any FedEx office location and provides deep discounts for printed products. The ability to print on demand to a remote location with very short turnaround times was crucial in many instances.
Conculsions
This project began as a pilot implemented at a single medical center in 2009 and grew into a VISN-wide initiative. After expansion, all 8 VISN 1 sites, the core project team was able to have substantive discussions about the project’s components, their relative importance in the dissemination process, and suggestions for alternatives to identified barriers.14
In FY15, the VISN 1 core project team has helped expand the project in VISN 19. The new project team, located at the Salt Lake City VAMC in Utah, has long been interested in improving communication and collaboration with the non-VA health care community. However, interest and enthusiasm alone are not sufficient for successful uptake. Many sites likely will not have special funding to implement this program.
As a tool to support successful implementation, essential implementation components were identified, based on experience. Local facilities can use the information included in Table 1 to consider and assess their assets, identify enthusiastic staff in their facility, consider creative local partnerships that would support implementation, and reach out to local rural health resources for assistance. Efforts to build collegial relationships with community providers will enhance communication and improve the quality of care received by all veterans.
Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.
Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.
1. Borowsky SJ, Cowper DC. Dual use of VA and non-VA primary care. J Gen Intern Med. 1999;14(5): 274-280.
2. Nayar P, Nguyen AT, Ojha D, Schmid KK, Apenteng B, Woodbridge P. Transitions in dual care for veterans: non-federal physician perspectives. J Community Health. 2013;38(2):225-237.
3. Liu CF, Bryson CL, Burgess JF Jr, Sharp N, Perkins M, Maciejewski ML. Use of outpatient care in VA and Medicare among disability-eligible and age-eligible veteran patients. BMC Health Serv Res. 2012;12:51.
4. Liu CF, Chapko M, Bryson CL, et al. Use of outpatient care in Veterans Health Administration and Medicare among veterans receiving primary care in community-based and hospital outpatient clinics. Health Serv Res. 2010;45(5, pt 1):1268-1286.
5. Lee PW, Markle PS, West AN, Lee RE. Use and quality of care at a VA outreach clinic in northern Maine. J Prim Care Community Health. 2012;3(3):159-163.
6. Petersen LA, Byrne MM, Daw CN, Hasche J, Reis B, Pietz K. Relationship between clinical conditions and use of Veterans Affairs health care among Medicare-enrolled veterans. Health Serv Res. 2010;45(3):762-791.
7. Helmer D, Sambamoorthi U, Shen Y, et al. Opting out of an integrated healthcare system: dual-system use is associated with poorer glycemic control in veterans with diabetes. Prim Care Diabetes. 2008;2(2):73-80.
8. Tarlov E, Lee TA, Weichle TW, et al. Reduced overall and event-free survival among colon cancer patients using dual system care. Cancer Epidemiol Biomarkers Prev. 2012;21(12):2231-2241.
9. Wolinsky FD, An H, Liu L, Miller TR, Rosenthal GE. Exploring the association of dual use of the VHA and Medicare with mortality: separating the contributions of inpatient and outpatient services. BMC Health Serv Res. 2007;7:70.
10. Wolinsky FD, Miller TR, An H, Brezinski PR, Vaughn TE, Rosenthal GE. Dual use of Medicare and the Veterans Health Administration: are there adverse health outcomes? BMC Health Serv Res. 2006;6:131.
11. Jia H, Zheng Y, Reker DM, et al. Multiple system utilization and mortality for veterans with stroke. Stroke. 2007;38(2):355-360.
12. Maciejewski ML, Wang V, Burgess JF Jr, Bryson CL, Perkins M, Liu CF. The continuity and quality of primary care. Med Care Res Rev. 2013;70(5):497-513.
13. Miller EA, Intrator O. Veterans use of non-VHA services: implications for policy and planning. Soc Work Public Health. 2012;27(4):379-391.
14. Tomioka M, Braun KL. Implementing evidence-based programs: a four-step protocol for assuring replication with fidelity. Health Promot Pract. 2013;14(6):850-858.
1. Borowsky SJ, Cowper DC. Dual use of VA and non-VA primary care. J Gen Intern Med. 1999;14(5): 274-280.
2. Nayar P, Nguyen AT, Ojha D, Schmid KK, Apenteng B, Woodbridge P. Transitions in dual care for veterans: non-federal physician perspectives. J Community Health. 2013;38(2):225-237.
3. Liu CF, Bryson CL, Burgess JF Jr, Sharp N, Perkins M, Maciejewski ML. Use of outpatient care in VA and Medicare among disability-eligible and age-eligible veteran patients. BMC Health Serv Res. 2012;12:51.
4. Liu CF, Chapko M, Bryson CL, et al. Use of outpatient care in Veterans Health Administration and Medicare among veterans receiving primary care in community-based and hospital outpatient clinics. Health Serv Res. 2010;45(5, pt 1):1268-1286.
5. Lee PW, Markle PS, West AN, Lee RE. Use and quality of care at a VA outreach clinic in northern Maine. J Prim Care Community Health. 2012;3(3):159-163.
6. Petersen LA, Byrne MM, Daw CN, Hasche J, Reis B, Pietz K. Relationship between clinical conditions and use of Veterans Affairs health care among Medicare-enrolled veterans. Health Serv Res. 2010;45(3):762-791.
7. Helmer D, Sambamoorthi U, Shen Y, et al. Opting out of an integrated healthcare system: dual-system use is associated with poorer glycemic control in veterans with diabetes. Prim Care Diabetes. 2008;2(2):73-80.
8. Tarlov E, Lee TA, Weichle TW, et al. Reduced overall and event-free survival among colon cancer patients using dual system care. Cancer Epidemiol Biomarkers Prev. 2012;21(12):2231-2241.
9. Wolinsky FD, An H, Liu L, Miller TR, Rosenthal GE. Exploring the association of dual use of the VHA and Medicare with mortality: separating the contributions of inpatient and outpatient services. BMC Health Serv Res. 2007;7:70.
10. Wolinsky FD, Miller TR, An H, Brezinski PR, Vaughn TE, Rosenthal GE. Dual use of Medicare and the Veterans Health Administration: are there adverse health outcomes? BMC Health Serv Res. 2006;6:131.
11. Jia H, Zheng Y, Reker DM, et al. Multiple system utilization and mortality for veterans with stroke. Stroke. 2007;38(2):355-360.
12. Maciejewski ML, Wang V, Burgess JF Jr, Bryson CL, Perkins M, Liu CF. The continuity and quality of primary care. Med Care Res Rev. 2013;70(5):497-513.
13. Miller EA, Intrator O. Veterans use of non-VHA services: implications for policy and planning. Soc Work Public Health. 2012;27(4):379-391.
14. Tomioka M, Braun KL. Implementing evidence-based programs: a four-step protocol for assuring replication with fidelity. Health Promot Pract. 2013;14(6):850-858.
Code Status Discussions
Informed consent is one of the ethical, legal, and moral foundations of modern medicine.[1] Key elements of informed consent include: details of the procedure, benefits of the procedure, significant risks involved, likelihood of the outcome if predictable, and alternative therapeutic options.[2] Although rarely identified as such, conversations eliciting patient preferences about cardiopulmonary resuscitation (CPR) are among the most common examples of obtaining informed consent. Nevertheless, discussing CPR preference, often called code status discussions, differs from other examples of obtaining informed consent in 2 important ways. First, they occur well in advance of the potential need for CPR, so that the patient is well enough to participate meaningfully in the discussion. Second, because the default assumption is for patients to undergo the intervention (i.e. CPR), the focus of code status discussions is often on informed refusal, namely a decision about a do not resuscitate(DNR) order.
Since the institution of the Patient Self‐Determination Act in 1990, hospitals are obliged to educate patients about choices regarding end‐of‐life care at the time of hospital admission.[3] In many teaching hospitals, this responsibility falls to the admitting physician, often a trainee, who determines the patient's preferences regarding CPR and documents whether the patient is full code or DNR.
Prior studies have raised concerns about the quality of these conversations, highlighting their superficial nature and revealing trainee dissatisfaction with the results.[4, 5] Importantly, studies have shown that patients are capable of assimilating information about CPR when presented accurately and completely, and that such information can dramatically alter their choices.[6, 7, 8] These findings suggest that patients who are adequately educated will make more informed decisions regarding CPR, and that well‐informed choices about CPR may differ from poorly informed ones.
Although several studies have questioned the quality of code status discussions, none of these studies frames these interactions as examples of informed consent. Therefore, the purpose of the study was to examine the content of code status discussions as reported by internal medicine residents to determine whether they meet the basic tenets of informed consent, thereby facilitating informed decision making.
METHODS
In an iterative, collaborative process, authors A.F.B. and M.K.B. (an internal medicine resident at the time of the study and a board‐certified palliative care specialist/oncologist with experience in survey development, respectively) developed a survey adapted from previously published surveys.[9, 10, 11] The survey solicited respondent demographics, frequency of code status conversations, content of these discussions, and barriers to discussions. The survey instrument can be viewed in the Supporting Information, Appendix A, in the online version of this article. We used a 5‐point frequency scale (almost nevernearly always) for questions regarding: specific aspects of the informed consent related to code status discussions, resident confidence in conducting code status discussions, and barriers to code status discussions. We used a checklist for questions regarding content of code status discussions and patient characteristics influencing code status discussions. Residents provided a numeric percentage answer to 2 knowledge‐based questions of postarrest outcomes: (1) likelihood a patient would survive a witnessed pulseless ventricular tachycardia event and (2) likelihood of survival of a pulseless electrical activity event. The survey was revised by a hospitalist with experience in survey design (G.C.H.). We piloted the survey with 15 residents not part of the subject population and made revisions based on their input.
We sent a link to the online survey over secure email to all 159 internal medicine residents at our urban‐based academic medical center in January 2012. The email described the purpose of the study and stated that participation in the study (or lack thereof) was voluntary, anonymous, and would not have ramifications within the residency program. As part of the recruitment email, we explicitly included the elements of informed consent for the study participants. Not all the questions were mandatory to complete the survey. We sent a reminder e‐mail on a weekly basis for a total of 3 times and closed the survey after 1 month. Our goal was a 60% (N = 95) response rate.
We tabulated the results by question. For analytic purposes, we aligned the content questions with key elements of informed consent as follows: step‐by‐step description of the events (details), patient‐specific likelihood of discharge if resuscitated (benefits), complications of resuscitation (risks), population‐based likelihood of discharge if resuscitated (likelihood), and opportunity for changing code status (alternatives). For the knowledge‐based questions, we deemed the answer correct if it was within 10% (5%) of published statistics from the 2010 national registry of cardiopulmonary resuscitation.[12] We stratified the key elements of informed consent and level of confidence by postgraduate year (PGY), comparing PGY1 residents versus PGY2 and PGY3 residents using 2 tests (or Fisher exact test for observations 5). We performed a univariate logistic regression analysis examining the relationship between confidence and reported use of informed consent elements in code discussions. The dependent variable of confidence in sufficient information having been provided for fully informed decision making was dichotomized as most of the time or nearly always versus other responses, whereas the independent variable was dichotomized as residents who reported using all 5 informed consent elements versus those who did not. We analyzed data using Stata 12 (StataCorp, College Station, TX).
The institutional review board of the Beth Israel Deaconess reviewed the study protocol and determined that it was exempt from institutional review board review.
RESULTS
One hundred of 159 (62.3%) internal medicine residents responded to the survey. Of the respondents 93% (N = 93) completed the survey. The 7% (N = 7) who did not complete the survey omitted the knowledge‐based questions and demographics. Approximately half of participants (54%, N = 50) were male. The majority of residents (85%, N = 79) had either occasional or frequent exposure to palliative care, with 10% (N = 9) having completed a palliative care rotation (Table 1).
| Characteristic | N (%) |
|---|---|
| |
| Sex, male | 50 (54) |
| PGY level | |
| PGY1 | 35 (38) |
| PGY2 | 33 (35) |
| PGY3 | 25 (27) |
| Exposure to palliative care | |
| Very little | 5 (5) |
| Occasional | 55 (59) |
| Frequent | 24 (26) |
| Completed palliative care elective | 9 (10) |
| What type of teaching did you have with code status discussions (check all that apply)? | |
| No teaching | 6 (6) |
| Lectures | 35 (38) |
| Small group teaching sessions | 57 (61) |
| Direct observation and feedback | 50 (54) |
| Exposure to palliative care consultation while rotating on the wards | 54 (58) |
| Other | 4 (4) |
| How much has your previous teaching about resuscitative measures influenced your behavior? | |
| Not at all | 1 (1) |
| Not very much | 15 (16) |
| A little bit | 39 (42) |
| A lot | 38 (41) |
The vast majority of residents (96%, N = 95) discussed code status with more than 40% of patients they admitted to the hospital (Table 2). Two‐thirds (66%, N = 65) of all residents had the conversation with at least 4 out of 5 (81%99% and 100%) patients they admitted to the hospital. Only 1% (N = 1) of residents who responded to the survey reported conducting code status discussions with 20% or fewer of the patients they admitted to the hospital.
| N (%) | |
|---|---|
| Percentage of inpatients with which you discuss code status, n = 99 | |
| 100% | 12 (12) |
| 8199% | 53 (54) |
| 6180% | 19 (19) |
| 4160% | 11 (11) |
| 2140% | 3 (3) |
| 120% | 1 (1) |
| Aspects of resuscitative measures routinely discussed, n = 100 | |
| Intubation/ventilation | 100 (100) |
| Chest compressions | 99 (99) |
| Defibrillation | 86 (86) |
| Surrogate decision maker | 61 (61) |
| Likelihood of success | 35 (35) |
| Quality of life | 32 (32) |
| Vasopressors | 13 (13) |
| Likelihood of discharge | 10 (10) |
| Possible role of depression | 10 (10) |
| Physical states worse than death | 7 (7) |
| Religious beliefs as a factor | 6 (6) |
| Makes recommendations for code status, n = 93 | |
| Never | 19 (20) |
| Rarely | 33 (35) |
| Sometimes | 33 (35) |
| Often | 7 (8) |
| Nearly always | 1 (1) |
Most residents (66%, N = 66) identified the healthcare proxy or surrogate decision maker most of the time or nearly always. In addition, most residents (62%, N = 62) reminded patients that they could reverse their code status at any time. Almost half included a description of step‐by‐step events during resuscitation (45%, N = 45) or factored in patient's comorbidities (43%, N = 43) when discussing resuscitation at least most of the time. Few residents described complications (31%, N = 31) or outcomes (17%, N = 17) of cardiopulmonary arrests to patients most of the time or nearly always. Most residents did not explore factors such as quality of life, role of depression or physical states worse than death, factors that could potentially affect patient decision making (Table 2). Few (9%, N = 8) internal medicine residents (often or nearly always) offered their opinion regarding a patient's code status.
Many factors influenced residents' decisions to have a code status conversation. At least 85% (N = 86) of residents reported that older age, particular admitting diagnoses, and multiple comorbidities made them more likely to have a code status discussion (see Supporting Table 1 in the online version of this article). Patient race/ethnicity did not influence this decision, with only 1 respondent reporting this factor as relevant.
Residents identified lack of time (49%, N = 49 responding often or nearly always) as the most frequent barrier to having a code status discussion, followed by lack of rapport (29%, N = 29). Lack of experience (6%, N = 6), lack of information about the patient's clinical status (11%, N = 11), and lack of knowledge about outcomes (13%, N = 13) did not represent frequent barriers for residents.
Fifty‐five percent (N = 53) of residents often or nearly always felt confident that they provided enough information for patients to make fully informed decisions about code status, and this did not differ by PGY status (PGY1 vs PGY2/3, P = 0.80, 2 test). However, only 8% (N = 8) of residents most of the time or nearly always addressed all 5 key elements of informed consent in reporting the content of their code status discussions. When stratified by training year, PGY2/3 residents were significantly more likely than PGY1 residents to factor in a patient's comorbidities when discussing resuscitation and were also significantly more likely to relay the likelihood of hospital discharge. They were not significantly more likely to discuss other key elements of informed consent (Table 3).
| Elements of Code Status Discussion (Most of the Time or Nearly Always), n = 100 | Elements | Total, N (%) | PGY1, N (%) | PGY2/3, N (%) | P Value |
|---|---|---|---|---|---|
| |||||
| Identify the patient's HCP or surrogate | 66 (66) | N/A | N/A | N/A | |
| Describe the step‐by‐step events that occur during resuscitative measures | Details | 45 (45) | 14 (40) | 28 (33) | 0.437 |
| Describe the complications associated with resuscitative measures | Risks | 31 (31) | 8 (23) | 19 (33) | 0.308 |
| Describe the likelihood the patient will be discharged from the hospital if resuscitated | Likelihood | 17 (17) | 2 (6) | 14 (24) | 0.025 |
| Factor in the patient's comorbidities when discussing the likelihood of discharge from the hospital if resuscitated | Benefits | 43 (43) | 8 (23) | 33 (57) | 0.002 |
| Tell the patient that decisions regarding code status can be changed at any time | Alternatives | 62 (62) | 18 (51) | 38 (66) | 0.179 |
Our subanalysis showed that residents reporting all 5 key elements of informed consent were associated with higher levels of confidence that they had provided enough information to patients for them to make an informed decision (odds ratio of 1.7, 95% confidence interval 1.2‐2.3).
For the first knowledge‐based question about witnessed pulseless ventricular tachycardia, according to the 2010 registry,[12] 64% survived the event (range of responses 1%90%). Six out of 92 (7%) respondents were within 5% of the correct answer. For the second question about survival after unwitnessed pulseless electrical activity, 41.5% survived the event according to the registry (range of responses 1%50%). Three out of 92 (3%) respondents gave estimates within 5% of the correct answer. Figures 1 and 2 display the ranges of responses from residents.
DISCUSSION
We found that although our internal medicine residents frequently have code status discussions with their patients, very few routinely report addressing all 5 key elements of informed consent. Furthermore, residents lack accurate knowledge about the outcomes of CPR, with most tending to underestimate the benefit expected of resuscitation. These deficiencies raise serious concerns about whether patients are receiving all the information essential to making fully informed decisions about their preferences for resuscitation.
The data demonstrate that the residents are routinely discussing code status and regularly discussing some aspects of the procedure itself, such as chest compressions, intubation, or defibrillation; the actual step‐by‐step events of CPR are being described less than half the time. It seems that residents mentally list the possible procedures that may occur in a code without a context for how one intervention would lead to another. Placing CPR into context is important, because studies have shown that more comprehensive discussions or the use of visual aids/videos that depict CPR in more detail improves patients' understanding of CPR and changes their decision about CPR, making them more likely to forego the procedure.[7, 8]
Residents report that they are more likely to have a code status discussion with patient's with multiple comorbidities, suggesting that they take into account information about the patient's clinical condition when deciding with which patients to address code status. They also recognize which patients are at increased risk for an in hospital cardiopulmonary arrest. Additionally, nearly half of residents factor in patient's comorbidities when discussing likelihood of discharge from the hospital, suggesting that they recognize that comorbidities can alter the outcome of CPR. Importantly, however, very few residents describe the likelihood the patient will be discharged from the hospital if resuscitated. Thus, residents in our sample have some insight into the impact of comorbidities on outcomes of CPR, but fail to provide their patients with any information about the outcome of CPR.
One reason residents may not discuss outcomes of CPR is because they do not know the data regarding outcomes. Although few residents reported that lack of knowledge of the risks and outcomes of CPR was a barrier, very few respondents answered the knowledge questions appropriately. Given how few residents gave an accurate estimate of CPR outcomes and simultaneously reported confidence in their code status discussions suggests that many residents fail to recognize their knowledge deficits. This finding corroborates other studies showing that residents don't know what they don't know[10] and may reflect their lack of education on CPR outcomes. Alternatively, some residents who underestimated the outcomes in the examples provided may have done so because, in their experience caring for patients with multiple comorbidites, the outcomes of CPR are in fact poorer than those in the cases described. Outcomes of CPR at our institution might differ from those quoted in the registry. However, given the prevalence of inaccuracy, both for under‐ and overestimation, it seems likely that a true knowledge deficit on the part of the residents still accounts for much of the error and should be a target for education. Understanding CPR outcomes is vital for informed decision making, and studies have shown that when patients have more information, it can substantially affect a patient's decision regarding resuscitation.[7, 13]
Residents are infrequently exploring key determinants that affect a patient's decision‐making process. Only one‐third of residents report discussing quality‐of‐life issues with patients during code status discussions. Understanding an individual patient's values and goals and how he or she describes a good quality of life can help guide the discussion and potential recommendations. For example, some patients may feel it is important to be alive regardless of the physical state, whereas others may feel that if there is not a chance to be independent in their activities of daily living, then they would not want to be resuscitated. By exploring patient's perceptions of what quality of life and physical states worse than death means, residents can better understand and assist in the decision‐making process of their patients.
Our data show that few residents offer a recommendation regarding code status. Thus, residents expect patients to make their own decision with the data provided. At the same time, many residents focus on the details of the procedural components of CPR with little mention of anticipated outcomes or inquiries into key determinants discussed above. Additionally, based on their response to the knowledge‐based questions, residents' estimates of survival, if offered, would be inaccurate. Thus, code status conversations by residents leave patients to make uninformed choices to consent to or refuse resuscitative measures.
When stratified by training year, PGY2/3 residents were significantly more likely than PGY1 residents to discuss likelihood of discharge from the hospital as well as factor in patients' comorbidities when discussing outcomes. Although there is a statistically significant improvement between PGY2/3 residents as compared to PGY1 residents, the numbers still show that most PGY2/3 residents and almost all PGY1 residents do not discuss the likelihood of discharge if resuscitated during code status discussions. In addition, there is no difference reported in other key areas of informed consent. Thus, though there is some improvement as housestaff advance in their training, PGY2 and PGY3 residents still do not discuss all 5 key elements of informed consent significantly more than PGY1 residents.
Our findings suggest an opportunity for additional education regarding how to address code status for internal medicine housestaff. Over half of the respondents reported small group teaching sessions, direct observation and feedback, and exposure to palliative care consultation during their clinical rotations; yet, very few of them included all the key elements of informed consent in their discussions. To address this, our institution is developing additional educational initiatives, including a faculty development program for teaching communication skills, using direct observation and feedback. The orientation didactic lecture series for housestaff now includes a lecture on CPR that highlights the data on outcomes and the importance of putting the step‐by‐step procedures of CPR into the context of potential benefits, such as survival to hospital discharge. The curriculum also includes a module on advance care planning for junior and senior residents during their ambulatory block, using simulation and feedback as part of the teaching methods.
There are limitations to this study. Studies based on surveys are subject to recall and selection bias, and we lack objective assessment of actual code status discussions. Furthermore, the nature of the study may lead to an overestimation of the quality of the code status discussions due to social acceptability bias; yet, our data clearly show that the key elements of informed consent are not included during these conversations. Another limitation is that our subjects were residents at a single institution, and our clinical practice may differ from other academic settings in the teaching environment and culture; yet, our findings mirror similar work done in other locations.[10, 14]
In conclusion, our results demonstrate that residents fail to meet standards of informed consent when discussing code status in that they do not provide sufficient information for patients to make an informed decision regarding resuscitation. Residents would benefit from education aimed at improving their knowledge of CPR outcomes as well as training on how to conduct these conversations effectively. Framing code status discussions as an example of an informed consent may help residents recognize the need for the key elements to be included in these conversations. In addition, training should focus on how to conduct these conversations in an efficient yet effective manner. This will require clear simple language, good communication skills, and training with observation and feedback by specialists trained in this field.
Disclosures
This work was presented at the Society of General Internal Medicine New England Regional Meeting, March 8, 2013, Yale Medical Center, New Haven, Connecticut. The authors report no conflicts of interest.
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- Beth Israel Deaconess Medical Center. Policy #PR‐02 45 CFR 46.11679(4):240–243.
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- , , , . Pre‐resuscitation factors associated with mortality in 49,130 cases of in‐hospital cardiac arrest: a report from the National Registry for Cardiopulmonary Resuscitation. Resuscitation. 2010;81:302–311.
- , , , . Resuscitation decision making in the elderly: the value of outcome data. J Gen Intern Med. 1993;8:295–300.
- , , . How do medical residents discuss resuscitation with patients? J Gen Intern Med. 1995;10:436–442.
Informed consent is one of the ethical, legal, and moral foundations of modern medicine.[1] Key elements of informed consent include: details of the procedure, benefits of the procedure, significant risks involved, likelihood of the outcome if predictable, and alternative therapeutic options.[2] Although rarely identified as such, conversations eliciting patient preferences about cardiopulmonary resuscitation (CPR) are among the most common examples of obtaining informed consent. Nevertheless, discussing CPR preference, often called code status discussions, differs from other examples of obtaining informed consent in 2 important ways. First, they occur well in advance of the potential need for CPR, so that the patient is well enough to participate meaningfully in the discussion. Second, because the default assumption is for patients to undergo the intervention (i.e. CPR), the focus of code status discussions is often on informed refusal, namely a decision about a do not resuscitate(DNR) order.
Since the institution of the Patient Self‐Determination Act in 1990, hospitals are obliged to educate patients about choices regarding end‐of‐life care at the time of hospital admission.[3] In many teaching hospitals, this responsibility falls to the admitting physician, often a trainee, who determines the patient's preferences regarding CPR and documents whether the patient is full code or DNR.
Prior studies have raised concerns about the quality of these conversations, highlighting their superficial nature and revealing trainee dissatisfaction with the results.[4, 5] Importantly, studies have shown that patients are capable of assimilating information about CPR when presented accurately and completely, and that such information can dramatically alter their choices.[6, 7, 8] These findings suggest that patients who are adequately educated will make more informed decisions regarding CPR, and that well‐informed choices about CPR may differ from poorly informed ones.
Although several studies have questioned the quality of code status discussions, none of these studies frames these interactions as examples of informed consent. Therefore, the purpose of the study was to examine the content of code status discussions as reported by internal medicine residents to determine whether they meet the basic tenets of informed consent, thereby facilitating informed decision making.
METHODS
In an iterative, collaborative process, authors A.F.B. and M.K.B. (an internal medicine resident at the time of the study and a board‐certified palliative care specialist/oncologist with experience in survey development, respectively) developed a survey adapted from previously published surveys.[9, 10, 11] The survey solicited respondent demographics, frequency of code status conversations, content of these discussions, and barriers to discussions. The survey instrument can be viewed in the Supporting Information, Appendix A, in the online version of this article. We used a 5‐point frequency scale (almost nevernearly always) for questions regarding: specific aspects of the informed consent related to code status discussions, resident confidence in conducting code status discussions, and barriers to code status discussions. We used a checklist for questions regarding content of code status discussions and patient characteristics influencing code status discussions. Residents provided a numeric percentage answer to 2 knowledge‐based questions of postarrest outcomes: (1) likelihood a patient would survive a witnessed pulseless ventricular tachycardia event and (2) likelihood of survival of a pulseless electrical activity event. The survey was revised by a hospitalist with experience in survey design (G.C.H.). We piloted the survey with 15 residents not part of the subject population and made revisions based on their input.
We sent a link to the online survey over secure email to all 159 internal medicine residents at our urban‐based academic medical center in January 2012. The email described the purpose of the study and stated that participation in the study (or lack thereof) was voluntary, anonymous, and would not have ramifications within the residency program. As part of the recruitment email, we explicitly included the elements of informed consent for the study participants. Not all the questions were mandatory to complete the survey. We sent a reminder e‐mail on a weekly basis for a total of 3 times and closed the survey after 1 month. Our goal was a 60% (N = 95) response rate.
We tabulated the results by question. For analytic purposes, we aligned the content questions with key elements of informed consent as follows: step‐by‐step description of the events (details), patient‐specific likelihood of discharge if resuscitated (benefits), complications of resuscitation (risks), population‐based likelihood of discharge if resuscitated (likelihood), and opportunity for changing code status (alternatives). For the knowledge‐based questions, we deemed the answer correct if it was within 10% (5%) of published statistics from the 2010 national registry of cardiopulmonary resuscitation.[12] We stratified the key elements of informed consent and level of confidence by postgraduate year (PGY), comparing PGY1 residents versus PGY2 and PGY3 residents using 2 tests (or Fisher exact test for observations 5). We performed a univariate logistic regression analysis examining the relationship between confidence and reported use of informed consent elements in code discussions. The dependent variable of confidence in sufficient information having been provided for fully informed decision making was dichotomized as most of the time or nearly always versus other responses, whereas the independent variable was dichotomized as residents who reported using all 5 informed consent elements versus those who did not. We analyzed data using Stata 12 (StataCorp, College Station, TX).
The institutional review board of the Beth Israel Deaconess reviewed the study protocol and determined that it was exempt from institutional review board review.
RESULTS
One hundred of 159 (62.3%) internal medicine residents responded to the survey. Of the respondents 93% (N = 93) completed the survey. The 7% (N = 7) who did not complete the survey omitted the knowledge‐based questions and demographics. Approximately half of participants (54%, N = 50) were male. The majority of residents (85%, N = 79) had either occasional or frequent exposure to palliative care, with 10% (N = 9) having completed a palliative care rotation (Table 1).
| Characteristic | N (%) |
|---|---|
| |
| Sex, male | 50 (54) |
| PGY level | |
| PGY1 | 35 (38) |
| PGY2 | 33 (35) |
| PGY3 | 25 (27) |
| Exposure to palliative care | |
| Very little | 5 (5) |
| Occasional | 55 (59) |
| Frequent | 24 (26) |
| Completed palliative care elective | 9 (10) |
| What type of teaching did you have with code status discussions (check all that apply)? | |
| No teaching | 6 (6) |
| Lectures | 35 (38) |
| Small group teaching sessions | 57 (61) |
| Direct observation and feedback | 50 (54) |
| Exposure to palliative care consultation while rotating on the wards | 54 (58) |
| Other | 4 (4) |
| How much has your previous teaching about resuscitative measures influenced your behavior? | |
| Not at all | 1 (1) |
| Not very much | 15 (16) |
| A little bit | 39 (42) |
| A lot | 38 (41) |
The vast majority of residents (96%, N = 95) discussed code status with more than 40% of patients they admitted to the hospital (Table 2). Two‐thirds (66%, N = 65) of all residents had the conversation with at least 4 out of 5 (81%99% and 100%) patients they admitted to the hospital. Only 1% (N = 1) of residents who responded to the survey reported conducting code status discussions with 20% or fewer of the patients they admitted to the hospital.
| N (%) | |
|---|---|
| Percentage of inpatients with which you discuss code status, n = 99 | |
| 100% | 12 (12) |
| 8199% | 53 (54) |
| 6180% | 19 (19) |
| 4160% | 11 (11) |
| 2140% | 3 (3) |
| 120% | 1 (1) |
| Aspects of resuscitative measures routinely discussed, n = 100 | |
| Intubation/ventilation | 100 (100) |
| Chest compressions | 99 (99) |
| Defibrillation | 86 (86) |
| Surrogate decision maker | 61 (61) |
| Likelihood of success | 35 (35) |
| Quality of life | 32 (32) |
| Vasopressors | 13 (13) |
| Likelihood of discharge | 10 (10) |
| Possible role of depression | 10 (10) |
| Physical states worse than death | 7 (7) |
| Religious beliefs as a factor | 6 (6) |
| Makes recommendations for code status, n = 93 | |
| Never | 19 (20) |
| Rarely | 33 (35) |
| Sometimes | 33 (35) |
| Often | 7 (8) |
| Nearly always | 1 (1) |
Most residents (66%, N = 66) identified the healthcare proxy or surrogate decision maker most of the time or nearly always. In addition, most residents (62%, N = 62) reminded patients that they could reverse their code status at any time. Almost half included a description of step‐by‐step events during resuscitation (45%, N = 45) or factored in patient's comorbidities (43%, N = 43) when discussing resuscitation at least most of the time. Few residents described complications (31%, N = 31) or outcomes (17%, N = 17) of cardiopulmonary arrests to patients most of the time or nearly always. Most residents did not explore factors such as quality of life, role of depression or physical states worse than death, factors that could potentially affect patient decision making (Table 2). Few (9%, N = 8) internal medicine residents (often or nearly always) offered their opinion regarding a patient's code status.
Many factors influenced residents' decisions to have a code status conversation. At least 85% (N = 86) of residents reported that older age, particular admitting diagnoses, and multiple comorbidities made them more likely to have a code status discussion (see Supporting Table 1 in the online version of this article). Patient race/ethnicity did not influence this decision, with only 1 respondent reporting this factor as relevant.
Residents identified lack of time (49%, N = 49 responding often or nearly always) as the most frequent barrier to having a code status discussion, followed by lack of rapport (29%, N = 29). Lack of experience (6%, N = 6), lack of information about the patient's clinical status (11%, N = 11), and lack of knowledge about outcomes (13%, N = 13) did not represent frequent barriers for residents.
Fifty‐five percent (N = 53) of residents often or nearly always felt confident that they provided enough information for patients to make fully informed decisions about code status, and this did not differ by PGY status (PGY1 vs PGY2/3, P = 0.80, 2 test). However, only 8% (N = 8) of residents most of the time or nearly always addressed all 5 key elements of informed consent in reporting the content of their code status discussions. When stratified by training year, PGY2/3 residents were significantly more likely than PGY1 residents to factor in a patient's comorbidities when discussing resuscitation and were also significantly more likely to relay the likelihood of hospital discharge. They were not significantly more likely to discuss other key elements of informed consent (Table 3).
| Elements of Code Status Discussion (Most of the Time or Nearly Always), n = 100 | Elements | Total, N (%) | PGY1, N (%) | PGY2/3, N (%) | P Value |
|---|---|---|---|---|---|
| |||||
| Identify the patient's HCP or surrogate | 66 (66) | N/A | N/A | N/A | |
| Describe the step‐by‐step events that occur during resuscitative measures | Details | 45 (45) | 14 (40) | 28 (33) | 0.437 |
| Describe the complications associated with resuscitative measures | Risks | 31 (31) | 8 (23) | 19 (33) | 0.308 |
| Describe the likelihood the patient will be discharged from the hospital if resuscitated | Likelihood | 17 (17) | 2 (6) | 14 (24) | 0.025 |
| Factor in the patient's comorbidities when discussing the likelihood of discharge from the hospital if resuscitated | Benefits | 43 (43) | 8 (23) | 33 (57) | 0.002 |
| Tell the patient that decisions regarding code status can be changed at any time | Alternatives | 62 (62) | 18 (51) | 38 (66) | 0.179 |
Our subanalysis showed that residents reporting all 5 key elements of informed consent were associated with higher levels of confidence that they had provided enough information to patients for them to make an informed decision (odds ratio of 1.7, 95% confidence interval 1.2‐2.3).
For the first knowledge‐based question about witnessed pulseless ventricular tachycardia, according to the 2010 registry,[12] 64% survived the event (range of responses 1%90%). Six out of 92 (7%) respondents were within 5% of the correct answer. For the second question about survival after unwitnessed pulseless electrical activity, 41.5% survived the event according to the registry (range of responses 1%50%). Three out of 92 (3%) respondents gave estimates within 5% of the correct answer. Figures 1 and 2 display the ranges of responses from residents.
DISCUSSION
We found that although our internal medicine residents frequently have code status discussions with their patients, very few routinely report addressing all 5 key elements of informed consent. Furthermore, residents lack accurate knowledge about the outcomes of CPR, with most tending to underestimate the benefit expected of resuscitation. These deficiencies raise serious concerns about whether patients are receiving all the information essential to making fully informed decisions about their preferences for resuscitation.
The data demonstrate that the residents are routinely discussing code status and regularly discussing some aspects of the procedure itself, such as chest compressions, intubation, or defibrillation; the actual step‐by‐step events of CPR are being described less than half the time. It seems that residents mentally list the possible procedures that may occur in a code without a context for how one intervention would lead to another. Placing CPR into context is important, because studies have shown that more comprehensive discussions or the use of visual aids/videos that depict CPR in more detail improves patients' understanding of CPR and changes their decision about CPR, making them more likely to forego the procedure.[7, 8]
Residents report that they are more likely to have a code status discussion with patient's with multiple comorbidities, suggesting that they take into account information about the patient's clinical condition when deciding with which patients to address code status. They also recognize which patients are at increased risk for an in hospital cardiopulmonary arrest. Additionally, nearly half of residents factor in patient's comorbidities when discussing likelihood of discharge from the hospital, suggesting that they recognize that comorbidities can alter the outcome of CPR. Importantly, however, very few residents describe the likelihood the patient will be discharged from the hospital if resuscitated. Thus, residents in our sample have some insight into the impact of comorbidities on outcomes of CPR, but fail to provide their patients with any information about the outcome of CPR.
One reason residents may not discuss outcomes of CPR is because they do not know the data regarding outcomes. Although few residents reported that lack of knowledge of the risks and outcomes of CPR was a barrier, very few respondents answered the knowledge questions appropriately. Given how few residents gave an accurate estimate of CPR outcomes and simultaneously reported confidence in their code status discussions suggests that many residents fail to recognize their knowledge deficits. This finding corroborates other studies showing that residents don't know what they don't know[10] and may reflect their lack of education on CPR outcomes. Alternatively, some residents who underestimated the outcomes in the examples provided may have done so because, in their experience caring for patients with multiple comorbidites, the outcomes of CPR are in fact poorer than those in the cases described. Outcomes of CPR at our institution might differ from those quoted in the registry. However, given the prevalence of inaccuracy, both for under‐ and overestimation, it seems likely that a true knowledge deficit on the part of the residents still accounts for much of the error and should be a target for education. Understanding CPR outcomes is vital for informed decision making, and studies have shown that when patients have more information, it can substantially affect a patient's decision regarding resuscitation.[7, 13]
Residents are infrequently exploring key determinants that affect a patient's decision‐making process. Only one‐third of residents report discussing quality‐of‐life issues with patients during code status discussions. Understanding an individual patient's values and goals and how he or she describes a good quality of life can help guide the discussion and potential recommendations. For example, some patients may feel it is important to be alive regardless of the physical state, whereas others may feel that if there is not a chance to be independent in their activities of daily living, then they would not want to be resuscitated. By exploring patient's perceptions of what quality of life and physical states worse than death means, residents can better understand and assist in the decision‐making process of their patients.
Our data show that few residents offer a recommendation regarding code status. Thus, residents expect patients to make their own decision with the data provided. At the same time, many residents focus on the details of the procedural components of CPR with little mention of anticipated outcomes or inquiries into key determinants discussed above. Additionally, based on their response to the knowledge‐based questions, residents' estimates of survival, if offered, would be inaccurate. Thus, code status conversations by residents leave patients to make uninformed choices to consent to or refuse resuscitative measures.
When stratified by training year, PGY2/3 residents were significantly more likely than PGY1 residents to discuss likelihood of discharge from the hospital as well as factor in patients' comorbidities when discussing outcomes. Although there is a statistically significant improvement between PGY2/3 residents as compared to PGY1 residents, the numbers still show that most PGY2/3 residents and almost all PGY1 residents do not discuss the likelihood of discharge if resuscitated during code status discussions. In addition, there is no difference reported in other key areas of informed consent. Thus, though there is some improvement as housestaff advance in their training, PGY2 and PGY3 residents still do not discuss all 5 key elements of informed consent significantly more than PGY1 residents.
Our findings suggest an opportunity for additional education regarding how to address code status for internal medicine housestaff. Over half of the respondents reported small group teaching sessions, direct observation and feedback, and exposure to palliative care consultation during their clinical rotations; yet, very few of them included all the key elements of informed consent in their discussions. To address this, our institution is developing additional educational initiatives, including a faculty development program for teaching communication skills, using direct observation and feedback. The orientation didactic lecture series for housestaff now includes a lecture on CPR that highlights the data on outcomes and the importance of putting the step‐by‐step procedures of CPR into the context of potential benefits, such as survival to hospital discharge. The curriculum also includes a module on advance care planning for junior and senior residents during their ambulatory block, using simulation and feedback as part of the teaching methods.
There are limitations to this study. Studies based on surveys are subject to recall and selection bias, and we lack objective assessment of actual code status discussions. Furthermore, the nature of the study may lead to an overestimation of the quality of the code status discussions due to social acceptability bias; yet, our data clearly show that the key elements of informed consent are not included during these conversations. Another limitation is that our subjects were residents at a single institution, and our clinical practice may differ from other academic settings in the teaching environment and culture; yet, our findings mirror similar work done in other locations.[10, 14]
In conclusion, our results demonstrate that residents fail to meet standards of informed consent when discussing code status in that they do not provide sufficient information for patients to make an informed decision regarding resuscitation. Residents would benefit from education aimed at improving their knowledge of CPR outcomes as well as training on how to conduct these conversations effectively. Framing code status discussions as an example of an informed consent may help residents recognize the need for the key elements to be included in these conversations. In addition, training should focus on how to conduct these conversations in an efficient yet effective manner. This will require clear simple language, good communication skills, and training with observation and feedback by specialists trained in this field.
Disclosures
This work was presented at the Society of General Internal Medicine New England Regional Meeting, March 8, 2013, Yale Medical Center, New Haven, Connecticut. The authors report no conflicts of interest.
Informed consent is one of the ethical, legal, and moral foundations of modern medicine.[1] Key elements of informed consent include: details of the procedure, benefits of the procedure, significant risks involved, likelihood of the outcome if predictable, and alternative therapeutic options.[2] Although rarely identified as such, conversations eliciting patient preferences about cardiopulmonary resuscitation (CPR) are among the most common examples of obtaining informed consent. Nevertheless, discussing CPR preference, often called code status discussions, differs from other examples of obtaining informed consent in 2 important ways. First, they occur well in advance of the potential need for CPR, so that the patient is well enough to participate meaningfully in the discussion. Second, because the default assumption is for patients to undergo the intervention (i.e. CPR), the focus of code status discussions is often on informed refusal, namely a decision about a do not resuscitate(DNR) order.
Since the institution of the Patient Self‐Determination Act in 1990, hospitals are obliged to educate patients about choices regarding end‐of‐life care at the time of hospital admission.[3] In many teaching hospitals, this responsibility falls to the admitting physician, often a trainee, who determines the patient's preferences regarding CPR and documents whether the patient is full code or DNR.
Prior studies have raised concerns about the quality of these conversations, highlighting their superficial nature and revealing trainee dissatisfaction with the results.[4, 5] Importantly, studies have shown that patients are capable of assimilating information about CPR when presented accurately and completely, and that such information can dramatically alter their choices.[6, 7, 8] These findings suggest that patients who are adequately educated will make more informed decisions regarding CPR, and that well‐informed choices about CPR may differ from poorly informed ones.
Although several studies have questioned the quality of code status discussions, none of these studies frames these interactions as examples of informed consent. Therefore, the purpose of the study was to examine the content of code status discussions as reported by internal medicine residents to determine whether they meet the basic tenets of informed consent, thereby facilitating informed decision making.
METHODS
In an iterative, collaborative process, authors A.F.B. and M.K.B. (an internal medicine resident at the time of the study and a board‐certified palliative care specialist/oncologist with experience in survey development, respectively) developed a survey adapted from previously published surveys.[9, 10, 11] The survey solicited respondent demographics, frequency of code status conversations, content of these discussions, and barriers to discussions. The survey instrument can be viewed in the Supporting Information, Appendix A, in the online version of this article. We used a 5‐point frequency scale (almost nevernearly always) for questions regarding: specific aspects of the informed consent related to code status discussions, resident confidence in conducting code status discussions, and barriers to code status discussions. We used a checklist for questions regarding content of code status discussions and patient characteristics influencing code status discussions. Residents provided a numeric percentage answer to 2 knowledge‐based questions of postarrest outcomes: (1) likelihood a patient would survive a witnessed pulseless ventricular tachycardia event and (2) likelihood of survival of a pulseless electrical activity event. The survey was revised by a hospitalist with experience in survey design (G.C.H.). We piloted the survey with 15 residents not part of the subject population and made revisions based on their input.
We sent a link to the online survey over secure email to all 159 internal medicine residents at our urban‐based academic medical center in January 2012. The email described the purpose of the study and stated that participation in the study (or lack thereof) was voluntary, anonymous, and would not have ramifications within the residency program. As part of the recruitment email, we explicitly included the elements of informed consent for the study participants. Not all the questions were mandatory to complete the survey. We sent a reminder e‐mail on a weekly basis for a total of 3 times and closed the survey after 1 month. Our goal was a 60% (N = 95) response rate.
We tabulated the results by question. For analytic purposes, we aligned the content questions with key elements of informed consent as follows: step‐by‐step description of the events (details), patient‐specific likelihood of discharge if resuscitated (benefits), complications of resuscitation (risks), population‐based likelihood of discharge if resuscitated (likelihood), and opportunity for changing code status (alternatives). For the knowledge‐based questions, we deemed the answer correct if it was within 10% (5%) of published statistics from the 2010 national registry of cardiopulmonary resuscitation.[12] We stratified the key elements of informed consent and level of confidence by postgraduate year (PGY), comparing PGY1 residents versus PGY2 and PGY3 residents using 2 tests (or Fisher exact test for observations 5). We performed a univariate logistic regression analysis examining the relationship between confidence and reported use of informed consent elements in code discussions. The dependent variable of confidence in sufficient information having been provided for fully informed decision making was dichotomized as most of the time or nearly always versus other responses, whereas the independent variable was dichotomized as residents who reported using all 5 informed consent elements versus those who did not. We analyzed data using Stata 12 (StataCorp, College Station, TX).
The institutional review board of the Beth Israel Deaconess reviewed the study protocol and determined that it was exempt from institutional review board review.
RESULTS
One hundred of 159 (62.3%) internal medicine residents responded to the survey. Of the respondents 93% (N = 93) completed the survey. The 7% (N = 7) who did not complete the survey omitted the knowledge‐based questions and demographics. Approximately half of participants (54%, N = 50) were male. The majority of residents (85%, N = 79) had either occasional or frequent exposure to palliative care, with 10% (N = 9) having completed a palliative care rotation (Table 1).
| Characteristic | N (%) |
|---|---|
| |
| Sex, male | 50 (54) |
| PGY level | |
| PGY1 | 35 (38) |
| PGY2 | 33 (35) |
| PGY3 | 25 (27) |
| Exposure to palliative care | |
| Very little | 5 (5) |
| Occasional | 55 (59) |
| Frequent | 24 (26) |
| Completed palliative care elective | 9 (10) |
| What type of teaching did you have with code status discussions (check all that apply)? | |
| No teaching | 6 (6) |
| Lectures | 35 (38) |
| Small group teaching sessions | 57 (61) |
| Direct observation and feedback | 50 (54) |
| Exposure to palliative care consultation while rotating on the wards | 54 (58) |
| Other | 4 (4) |
| How much has your previous teaching about resuscitative measures influenced your behavior? | |
| Not at all | 1 (1) |
| Not very much | 15 (16) |
| A little bit | 39 (42) |
| A lot | 38 (41) |
The vast majority of residents (96%, N = 95) discussed code status with more than 40% of patients they admitted to the hospital (Table 2). Two‐thirds (66%, N = 65) of all residents had the conversation with at least 4 out of 5 (81%99% and 100%) patients they admitted to the hospital. Only 1% (N = 1) of residents who responded to the survey reported conducting code status discussions with 20% or fewer of the patients they admitted to the hospital.
| N (%) | |
|---|---|
| Percentage of inpatients with which you discuss code status, n = 99 | |
| 100% | 12 (12) |
| 8199% | 53 (54) |
| 6180% | 19 (19) |
| 4160% | 11 (11) |
| 2140% | 3 (3) |
| 120% | 1 (1) |
| Aspects of resuscitative measures routinely discussed, n = 100 | |
| Intubation/ventilation | 100 (100) |
| Chest compressions | 99 (99) |
| Defibrillation | 86 (86) |
| Surrogate decision maker | 61 (61) |
| Likelihood of success | 35 (35) |
| Quality of life | 32 (32) |
| Vasopressors | 13 (13) |
| Likelihood of discharge | 10 (10) |
| Possible role of depression | 10 (10) |
| Physical states worse than death | 7 (7) |
| Religious beliefs as a factor | 6 (6) |
| Makes recommendations for code status, n = 93 | |
| Never | 19 (20) |
| Rarely | 33 (35) |
| Sometimes | 33 (35) |
| Often | 7 (8) |
| Nearly always | 1 (1) |
Most residents (66%, N = 66) identified the healthcare proxy or surrogate decision maker most of the time or nearly always. In addition, most residents (62%, N = 62) reminded patients that they could reverse their code status at any time. Almost half included a description of step‐by‐step events during resuscitation (45%, N = 45) or factored in patient's comorbidities (43%, N = 43) when discussing resuscitation at least most of the time. Few residents described complications (31%, N = 31) or outcomes (17%, N = 17) of cardiopulmonary arrests to patients most of the time or nearly always. Most residents did not explore factors such as quality of life, role of depression or physical states worse than death, factors that could potentially affect patient decision making (Table 2). Few (9%, N = 8) internal medicine residents (often or nearly always) offered their opinion regarding a patient's code status.
Many factors influenced residents' decisions to have a code status conversation. At least 85% (N = 86) of residents reported that older age, particular admitting diagnoses, and multiple comorbidities made them more likely to have a code status discussion (see Supporting Table 1 in the online version of this article). Patient race/ethnicity did not influence this decision, with only 1 respondent reporting this factor as relevant.
Residents identified lack of time (49%, N = 49 responding often or nearly always) as the most frequent barrier to having a code status discussion, followed by lack of rapport (29%, N = 29). Lack of experience (6%, N = 6), lack of information about the patient's clinical status (11%, N = 11), and lack of knowledge about outcomes (13%, N = 13) did not represent frequent barriers for residents.
Fifty‐five percent (N = 53) of residents often or nearly always felt confident that they provided enough information for patients to make fully informed decisions about code status, and this did not differ by PGY status (PGY1 vs PGY2/3, P = 0.80, 2 test). However, only 8% (N = 8) of residents most of the time or nearly always addressed all 5 key elements of informed consent in reporting the content of their code status discussions. When stratified by training year, PGY2/3 residents were significantly more likely than PGY1 residents to factor in a patient's comorbidities when discussing resuscitation and were also significantly more likely to relay the likelihood of hospital discharge. They were not significantly more likely to discuss other key elements of informed consent (Table 3).
| Elements of Code Status Discussion (Most of the Time or Nearly Always), n = 100 | Elements | Total, N (%) | PGY1, N (%) | PGY2/3, N (%) | P Value |
|---|---|---|---|---|---|
| |||||
| Identify the patient's HCP or surrogate | 66 (66) | N/A | N/A | N/A | |
| Describe the step‐by‐step events that occur during resuscitative measures | Details | 45 (45) | 14 (40) | 28 (33) | 0.437 |
| Describe the complications associated with resuscitative measures | Risks | 31 (31) | 8 (23) | 19 (33) | 0.308 |
| Describe the likelihood the patient will be discharged from the hospital if resuscitated | Likelihood | 17 (17) | 2 (6) | 14 (24) | 0.025 |
| Factor in the patient's comorbidities when discussing the likelihood of discharge from the hospital if resuscitated | Benefits | 43 (43) | 8 (23) | 33 (57) | 0.002 |
| Tell the patient that decisions regarding code status can be changed at any time | Alternatives | 62 (62) | 18 (51) | 38 (66) | 0.179 |
Our subanalysis showed that residents reporting all 5 key elements of informed consent were associated with higher levels of confidence that they had provided enough information to patients for them to make an informed decision (odds ratio of 1.7, 95% confidence interval 1.2‐2.3).
For the first knowledge‐based question about witnessed pulseless ventricular tachycardia, according to the 2010 registry,[12] 64% survived the event (range of responses 1%90%). Six out of 92 (7%) respondents were within 5% of the correct answer. For the second question about survival after unwitnessed pulseless electrical activity, 41.5% survived the event according to the registry (range of responses 1%50%). Three out of 92 (3%) respondents gave estimates within 5% of the correct answer. Figures 1 and 2 display the ranges of responses from residents.
DISCUSSION
We found that although our internal medicine residents frequently have code status discussions with their patients, very few routinely report addressing all 5 key elements of informed consent. Furthermore, residents lack accurate knowledge about the outcomes of CPR, with most tending to underestimate the benefit expected of resuscitation. These deficiencies raise serious concerns about whether patients are receiving all the information essential to making fully informed decisions about their preferences for resuscitation.
The data demonstrate that the residents are routinely discussing code status and regularly discussing some aspects of the procedure itself, such as chest compressions, intubation, or defibrillation; the actual step‐by‐step events of CPR are being described less than half the time. It seems that residents mentally list the possible procedures that may occur in a code without a context for how one intervention would lead to another. Placing CPR into context is important, because studies have shown that more comprehensive discussions or the use of visual aids/videos that depict CPR in more detail improves patients' understanding of CPR and changes their decision about CPR, making them more likely to forego the procedure.[7, 8]
Residents report that they are more likely to have a code status discussion with patient's with multiple comorbidities, suggesting that they take into account information about the patient's clinical condition when deciding with which patients to address code status. They also recognize which patients are at increased risk for an in hospital cardiopulmonary arrest. Additionally, nearly half of residents factor in patient's comorbidities when discussing likelihood of discharge from the hospital, suggesting that they recognize that comorbidities can alter the outcome of CPR. Importantly, however, very few residents describe the likelihood the patient will be discharged from the hospital if resuscitated. Thus, residents in our sample have some insight into the impact of comorbidities on outcomes of CPR, but fail to provide their patients with any information about the outcome of CPR.
One reason residents may not discuss outcomes of CPR is because they do not know the data regarding outcomes. Although few residents reported that lack of knowledge of the risks and outcomes of CPR was a barrier, very few respondents answered the knowledge questions appropriately. Given how few residents gave an accurate estimate of CPR outcomes and simultaneously reported confidence in their code status discussions suggests that many residents fail to recognize their knowledge deficits. This finding corroborates other studies showing that residents don't know what they don't know[10] and may reflect their lack of education on CPR outcomes. Alternatively, some residents who underestimated the outcomes in the examples provided may have done so because, in their experience caring for patients with multiple comorbidites, the outcomes of CPR are in fact poorer than those in the cases described. Outcomes of CPR at our institution might differ from those quoted in the registry. However, given the prevalence of inaccuracy, both for under‐ and overestimation, it seems likely that a true knowledge deficit on the part of the residents still accounts for much of the error and should be a target for education. Understanding CPR outcomes is vital for informed decision making, and studies have shown that when patients have more information, it can substantially affect a patient's decision regarding resuscitation.[7, 13]
Residents are infrequently exploring key determinants that affect a patient's decision‐making process. Only one‐third of residents report discussing quality‐of‐life issues with patients during code status discussions. Understanding an individual patient's values and goals and how he or she describes a good quality of life can help guide the discussion and potential recommendations. For example, some patients may feel it is important to be alive regardless of the physical state, whereas others may feel that if there is not a chance to be independent in their activities of daily living, then they would not want to be resuscitated. By exploring patient's perceptions of what quality of life and physical states worse than death means, residents can better understand and assist in the decision‐making process of their patients.
Our data show that few residents offer a recommendation regarding code status. Thus, residents expect patients to make their own decision with the data provided. At the same time, many residents focus on the details of the procedural components of CPR with little mention of anticipated outcomes or inquiries into key determinants discussed above. Additionally, based on their response to the knowledge‐based questions, residents' estimates of survival, if offered, would be inaccurate. Thus, code status conversations by residents leave patients to make uninformed choices to consent to or refuse resuscitative measures.
When stratified by training year, PGY2/3 residents were significantly more likely than PGY1 residents to discuss likelihood of discharge from the hospital as well as factor in patients' comorbidities when discussing outcomes. Although there is a statistically significant improvement between PGY2/3 residents as compared to PGY1 residents, the numbers still show that most PGY2/3 residents and almost all PGY1 residents do not discuss the likelihood of discharge if resuscitated during code status discussions. In addition, there is no difference reported in other key areas of informed consent. Thus, though there is some improvement as housestaff advance in their training, PGY2 and PGY3 residents still do not discuss all 5 key elements of informed consent significantly more than PGY1 residents.
Our findings suggest an opportunity for additional education regarding how to address code status for internal medicine housestaff. Over half of the respondents reported small group teaching sessions, direct observation and feedback, and exposure to palliative care consultation during their clinical rotations; yet, very few of them included all the key elements of informed consent in their discussions. To address this, our institution is developing additional educational initiatives, including a faculty development program for teaching communication skills, using direct observation and feedback. The orientation didactic lecture series for housestaff now includes a lecture on CPR that highlights the data on outcomes and the importance of putting the step‐by‐step procedures of CPR into the context of potential benefits, such as survival to hospital discharge. The curriculum also includes a module on advance care planning for junior and senior residents during their ambulatory block, using simulation and feedback as part of the teaching methods.
There are limitations to this study. Studies based on surveys are subject to recall and selection bias, and we lack objective assessment of actual code status discussions. Furthermore, the nature of the study may lead to an overestimation of the quality of the code status discussions due to social acceptability bias; yet, our data clearly show that the key elements of informed consent are not included during these conversations. Another limitation is that our subjects were residents at a single institution, and our clinical practice may differ from other academic settings in the teaching environment and culture; yet, our findings mirror similar work done in other locations.[10, 14]
In conclusion, our results demonstrate that residents fail to meet standards of informed consent when discussing code status in that they do not provide sufficient information for patients to make an informed decision regarding resuscitation. Residents would benefit from education aimed at improving their knowledge of CPR outcomes as well as training on how to conduct these conversations effectively. Framing code status discussions as an example of an informed consent may help residents recognize the need for the key elements to be included in these conversations. In addition, training should focus on how to conduct these conversations in an efficient yet effective manner. This will require clear simple language, good communication skills, and training with observation and feedback by specialists trained in this field.
Disclosures
This work was presented at the Society of General Internal Medicine New England Regional Meeting, March 8, 2013, Yale Medical Center, New Haven, Connecticut. The authors report no conflicts of interest.
- , , , , Medical informed consent: general considerations for physicians. Mayo Clin Proc. 2008;83(3):313–319.
- Beth Israel Deaconess Medical Center. Policy #PR‐02 45 CFR 46.11679(4):240–243.
- , , , . Medical residents' perspectives on discussions of advanced directives: can prior experience affect how they approach patients? J Palliat Med. 2007;10(3):712–720.
- , , , , . Code status discussions between attending hospitalist physicians and medical patients at hospital admission. J Gen Intern Med. 2010;26(4):359–366.
- , , . The influence of the probability of survival on patient's preferences regarding cardiopulmonary resuscitation. N Engl J Med. 1994;330:545–549.
- , , , , . Using video images to improve the accuracy of surrogate decision‐making: a randomized controlled trial. J Am Med Dir Assoc. 2009;10(8):575–580.
- , , , et al. Use of video to facilitate end‐of‐life discussions with patients with cancer: a randomized controlled trial. J Clin Oncol. 2010;28(2):305–310.
- , , , , , . Resident Approaches to Advance Care Planning on the Day of Hospital Admission. Arch Intern Med. 2006;166:1597–1602.
- , , , . Assessing competence of residents to discuss end‐of‐life issues. J Palliat Med. 2005;8(2):363–371.
- , , , et al. Code status discussions and goals of care among hospitalised adults. J Med Ethics. 2009;35:338–342.
- , , , . Pre‐resuscitation factors associated with mortality in 49,130 cases of in‐hospital cardiac arrest: a report from the National Registry for Cardiopulmonary Resuscitation. Resuscitation. 2010;81:302–311.
- , , , . Resuscitation decision making in the elderly: the value of outcome data. J Gen Intern Med. 1993;8:295–300.
- , , . How do medical residents discuss resuscitation with patients? J Gen Intern Med. 1995;10:436–442.
- , , , , Medical informed consent: general considerations for physicians. Mayo Clin Proc. 2008;83(3):313–319.
- Beth Israel Deaconess Medical Center. Policy #PR‐02 45 CFR 46.11679(4):240–243.
- , , , . Medical residents' perspectives on discussions of advanced directives: can prior experience affect how they approach patients? J Palliat Med. 2007;10(3):712–720.
- , , , , . Code status discussions between attending hospitalist physicians and medical patients at hospital admission. J Gen Intern Med. 2010;26(4):359–366.
- , , . The influence of the probability of survival on patient's preferences regarding cardiopulmonary resuscitation. N Engl J Med. 1994;330:545–549.
- , , , , . Using video images to improve the accuracy of surrogate decision‐making: a randomized controlled trial. J Am Med Dir Assoc. 2009;10(8):575–580.
- , , , et al. Use of video to facilitate end‐of‐life discussions with patients with cancer: a randomized controlled trial. J Clin Oncol. 2010;28(2):305–310.
- , , , , , . Resident Approaches to Advance Care Planning on the Day of Hospital Admission. Arch Intern Med. 2006;166:1597–1602.
- , , , . Assessing competence of residents to discuss end‐of‐life issues. J Palliat Med. 2005;8(2):363–371.
- , , , et al. Code status discussions and goals of care among hospitalised adults. J Med Ethics. 2009;35:338–342.
- , , , . Pre‐resuscitation factors associated with mortality in 49,130 cases of in‐hospital cardiac arrest: a report from the National Registry for Cardiopulmonary Resuscitation. Resuscitation. 2010;81:302–311.
- , , , . Resuscitation decision making in the elderly: the value of outcome data. J Gen Intern Med. 1993;8:295–300.
- , , . How do medical residents discuss resuscitation with patients? J Gen Intern Med. 1995;10:436–442.
© 2015 Society of Hospital Medicine
Imiquimod Cream 2.5% and 3.75% Applied Once Daily to Treat External Genital Warts in Men
External genital warts (EGWs), which are caused by infection with select types of human papillomavirus (HPV), are one of the most prevalent and fastest growing sexually transmitted infections.1 External genital warts affect approximately 1% of sexually active adults in the United States and Europe, with another 15% having subclinical infections; more than 1 million new cases of EGWs are diagnosed annually.2-4 Although the condition is not life threatening, lesions can cause symptoms, such as burning, itching, bleeding, pain and dyspareunia, and potential urethral or rectal obstruction. External genital warts also have been associated with adverse psychological effects.5-8
The time between exposure to HPV and development of EGWs can vary from a few weeks to several months or years (median, 2.9 months).9 Many HPV infections are mild and transient, resolving spontaneously.10 As many as 30% of EGWs will regress over 4 months and approximately 90% clear within 2 years.11,12 However, even with treatment, the median time to resolution is 5.9 months.9
Imiquimod cream 5%, which has been successfully used to treat EGWs since it was approved by the US Food and Drug Administration in 1997, is applied to lesions 3 times weekly at bedtime until clearance is achieved or for a maximum of 16 weeks.13 In clinical studies, complete clearance has been reported in 35% to 75% of participants.14-21 However, it is important to note that not all anogenital regions with warts were required to be treated in these studies,14-21 and newly arising warts were not included in the analysis.17 Reported clearance rates were higher and median clearance time was shorter in women.17 Relatively low recurrence rates (6%–26%) have been reported after successful clearance of EGWs.16,17,20,21
Long treatment durations are always a concern for patient adherence. Although increasing the dosing frequency with imiquimod cream 5% might be considered an attractive option to reduce the length of the treatment course, it has resulted in greater incidence and severity of local adverse events (AEs) in some studies without improved efficacy.18,22,23 Thus lower concentrations of imiquimod (ie, 2.5% and 3.75% formulations) were developed to potentially decrease treatment duration and provide a daily dosing regimen.
We report the results of 2 identical, placebo-controlled, phase 3 studies evaluating the safety and efficacy of imiquimod cream 2.5% and 3.75% in treating EGWs in men. Pooled results from a female subgroup previously have been reported.24 Although the percentage of women who reported ever being diagnosed with EGWs was higher than in men (7.2% vs 4%) in one survey,25 other assessments have found a similar prevalence of EGWs among both genders.26-28 We provide important insights herein by reporting efficacy and tolerability data for imiquimod cream 2.5% and 3.75% in the treatment of EGWs in males.
Methods
Study Design
Male patients aged 12 years and older with 2 to 30 EGWs in the inguinal, perineal, and/or perianal areas as well as on the glans penis, penile shaft, scrotum, and/or foreskin were enrolled in 2 identical, multicenter, randomized, parallel-group, double-blind, placebo-controlled studies. Participants were randomized (2:2:1) to self-treatment with imiquimod cream 3.75% or 2.5% or placebo once daily until complete clearance was achieved or for a maximum of 8 weeks (end of treatment [EOT]). There was a follow-up period of up to 8 weeks (end of study [EOS]) in participants who did not achieve complete clearance by EOT. All participants who achieved complete clearance by EOS entered a 12-week observational follow-up period to assess recurrence.
Primary and Secondary Efficacy Criteria
The primary efficacy end point was complete clearance rate, which was defined as the proportion of participants by the EOS visit with zero EGWs (that either existed at baseline and any warts developing during the study) in all anogenital anatomic areas. It is important to note that this primary efficacy end point was very conservative in that it included any new warts occurring during the study that may not have received a full treatment course. Lesions were counted in all assessed anatomic areas without distinction between those that were identified at baseline or those that were newly identified during the study period. If new EGWs appeared during the study in new anatomic areas, such lesions were treated with the study medication as they appeared. Therefore, any newly arising EGWs received less than the full course of treatment, as therapy was not extended beyond the 8-week study period. Participants were evaluated for the presence of any EGWs in all anatomic areas without distinction between lesions that were present at baseline and newly arising EGWs. Therefore, development of new EGWs during the study period could potentially lower clearance rates.
Secondary end points were 75% or more and 50% or more reduction in EGW count, change in EGW count from baseline, and 12-week sustained clearance rate.
Safety
Safety assessments of AEs, both volunteered and elicited, were made throughout the study.
Study Oversight
The study was conducted in accordance with the ethical principles specified in the Declaration of Helsinki and in compliance with the requirements of local regulatory committees. All participants provided written informed consent.
Statistical Analysis
Statistical analysis for intention-to-treat (ITT) imputations was made for missing data points using last observation carried forward (LOCF). Complete clearance rates and partial clearance rates were analyzed using Cochran-Mantel-Haenszel statistics stratified by center and by gender for the overall population analyses. The percentage change in EGW count was analyzed using analysis of covariance. All statistical analyses were performed using SAS software (version 9.1.3).
Results
Study Population
Study characteristics by treatment group are summarized in the Table. Overall, 447 male participants (225 from study 1 and 222 from study 2) were included in the study. The majority of participants (84.1%) had EGWs on the penile shaft with only 1 affected region in just over half of participants (51.9%). Most participants (70.2%) were 35 years or younger, and approximately half had a baseline EGW count of 7 or less (50.6%). More than 20% of participants had an affected wart surface area greater than 150 mm2 at baseline, and in more than 60% of participants, the duration from first diagnosis of EGWs to enrollment in the study was more than 1 year.
Primary Efficacy End Point
Imiquimod cream 3.75% was statistically superior to placebo in study 1 and study 2 (P=.015 and P=.019, respectively)(Figure) in providing complete clearance of all EGWs (baseline or new) at EOS. Imiquimod cream 2.5% was only statistically superior to placebo in study 2 (P=.034). Importantly, there were a number of participants who did not achieve complete clearance at EOT who continued to improve posttreatment. The percentage of participants treated with imiquimod cream 3.75% and 2.5% who were completely cleared at EOT was 12.0% (14.7% study 1 and 9.1% study 2) and 7.1% (7.2% study 1 and 7.1% study 2), respectively, compared to complete clearance rates of 18.6% (20.0% study 1 and 17.0% study 2) and 14.3% (13.3% study 1 and 15.3% study 2), respectively, at EOS (ITT population).
|
Complete clearance rates (defined as the proportion of participants by the end-of-study [EOS] visit with zero external genital warts in all anogenital anatomic areas) in the intention-to-treat (ITT) population (last observation carried forward [LOCF])(A) and per-protocol (PP) population (OC [observed case])(B), including both individual and pooled study data. |
In both studies complete clearance rates were significantly higher (P<.019 both studies) with imiquimod cream 3.75% compared with placebo at weeks 10 through 16 (EOS). In study 2, complete clearance rates were significantly higher (P<.049) with imiquimod cream 2.5% compared to placebo from week 14 to week 16 (EOS). Complete clearance rates were highest in participants treated with imiquimod cream 3.75% who had EGWs in the perianal region or on the glans penis (28.6% and 33.3%, respectively); however, the number of participants in both groups was relatively small.
Overall, 18.8% of participants took rest periods. Complete clearance rates were higher in men who took a rest period (26.5% and 27.3% for imiquimod cream 3.75% and 2.5%, respectively), perhaps reflecting a more brisk immunological response. The frequency, duration, and number of dosing days prior to the rest period were similar in the active treatment groups and lower in the placebo group.
There was a tendency for older participants (ie, >35 years) and those with lower baseline EGW counts (ie, ≤7) to respond better. Participants treated with imiquimod cream 3.75% also tended to respond best to treatment when only 1 anatomic area was affected.
Secondary Efficacy End Points
The proportion of male participants with at least a 75% reduction in EGW count from baseline at EOS was statistically superior with imiquimod 3.75% compared to placebo in study 1 and study 2 (P=.001 and P=.008, respectively). Statistical superiority also was apparent with imiquimod cream 2.5% versus placebo in study 2 (P=.013). Overall, 20.2% (18.1% study 1 and 22.4% study 2) and 27.3% (30.5% study 1 and 23.9% study 2) of participants achieved at least a 75% reduction in wart count at EOS with imiquimod cream 2.5% and 3.75%, respectively (pooled data).
Percentage change in EGW count from baseline at EOS was 35.8% and 24.1% with imiquimod cream 3.75% in study 1 and study 2, respectively, both significantly better than placebo (P=.002 and P=.011, respectively). Change in EGW count following treatment with imiquimod cream 2.5% was only significant in study 2 (P=.001).
The median time to complete clearance was shorter in the 2 active treatment groups compared with placebo. For those participants who attained complete clearance, the median time to complete clearance ranged from 57 to 59 days in the imiquimod cream 3.75% groups (studies 1 and 2, respectively), 60 to 74 days in the imiquimod 2.5% cream groups (studies 1 and 2, respectively), and 76 to 81 days with placebo (studies 2 and 1, respectively).
Safety
Less than one-third of male participants in each treatment group experienced AEs during the studies. The incidence of serious adverse events (SAEs) and AEs leading to study discontinuation was low. In total, 4 participants (0.9% [3 in the imiquimod cream 2.5% group and 1 in the imiquimod cream 3.75% group]) had AEs that led to study discontinuation. Application-site reactions were reported in a total of 46 participants (10.3%). The incidence and severity of local skin reactions was mostly mild or moderate, similar in both active treatment groups, and higher than in the placebo group. Local skin reactions were coincident with the treatment period and rapidly decreased when treatment was concluded. There were no clinically meaningful trends in vital sign measurements or laboratory measurements.
Comment
Imiquimod cream 5% has been shown to be a safe and effective treatment of EGWs. Our study was designed to evaluate lower concentrations of imiquimod cream (2.5% and 3.75%), which may permit daily dosing and a shortened treatment course in men with EGWs.
Efficacy of imiquimod cream 2.5% and 3.75% was established through both primary and secondary end points, though only the higher concentration was significantly more effective than placebo in both studies. In addition, a number of participants who were not completely cleared following 8 weeks of treatment went on to be completely cleared at EOS, demonstrating continued activity of imiquimod despite cessation of active treatment.
Imiquimod cream 3.75% was particularly effective when compared to placebo, with 18.6% of participants completely cleared at EOS, though the PP (observed case) results (22.7%) may be more encouraging and can be used to motivate patients.
Although there are limitations in making direct comparisons between studies, complete clearance rates in our studies were lower than those reported previously with imiquimod cream 5%.17 Lower efficacy rates might be expected given the differences in methodology. In the 2 studies reported here, participants had to have no EGWs (baseline or new, treated or untreated) in any of the anogenital areas specified to be reported as having achieved complete clearance. In earlier studies with imiquimod cream 5%, not all anogenital regions were required to be treated, and any new EGWs arising during treatment were not included in the analysis.17 Also, our analysis focused purely on a male patient population in which efficacy results tend to be lower regardless of treatment modality employed.
Recurrence is another important issue in the treatment of EGWs. Although not studied specifically in a male population, recurrence rates of 16.7% to 17.7% were seen in the 3 months following successful treatment with imiquimod cream 2.5% and 3.75% in the 2 pivotal studies. These results were consistent with the recurrence rates reported following successful treatment with imiquimod cream 5%.17
In general, complete clearance rates increased in a dose-dependent manner. Complete clearance rates were lower in the male subpopulation across all treatment groups compared to those previously reported in females,24 which was consistent with prior results reported for imiquimod cream 5% as well as other topical treatments.17 It has been suggested that this difference may be due in part to the distribution of female EGWs in areas of less keratinization. Complete clearance rates in the current analysis tended to be higher in male participants with baseline EGWs in anatomic sites with less keratinized skin such as the perianal, perineal, or glans penis areas.
Daily application of imiquimod cream 2.5% and 3.75% generally was well tolerated. Most reported AEs were mild or moderate, and few participants discontinued because of AEs. Few SAEs were reported and none were considered to be treatment related. There was no difference in the incidence rates of AEs between the 2 active treatments. The incidence of SAEs and study discontinuations was much lower than previously reported in the female cohort of these 2 studies.24
Conclusion
In conclusion, 2 well-controlled studies of males with EGWs who were treated for up to 8 weeks with imiquimod cream 2.5% and 3.75% applied daily demonstrated good tolerability and superior efficacy to placebo in complete clearance of all baseline and newly arising warts in addition to reducing EGW counts.
Acknowledgments—The authors thank Christina Cognata Smith, PharmD, and Mandeep Kaur, MD (both previously of Valeant Pharmaceuticals North America, LLC, Bridgewater, New Jersey), as well as Brian Bulley, MSc (Inergy Limited, Lindfield, West Sussex, United Kingdom), for assistance with the preparation of the manuscript. Valeant Pharmaceuticals North America, LLC, funded Inergy’s activities pertaining to this analysis.
1. Weinstock H, Berman S, Cates W. Sexually transmitted infections in American youth: incidence and prevalence estimates, 2000. Perspect Sex Reprod Health. 2004;36:6-10.
2. Dunne EF, Unger ER, Sternberg M, et al. Prevalence of HPV infection among females in the United States. JAMA. 2007;297:813-819.
3. Koutsky L. Epidemiology of genital human papillomavirus infection. Am J Med. 1997;102:3-8.
4. Kjaer SK, Tran TN, Sparen P, et al. The burden of genital warts: a study of nearly 70,000 women from the general female population in the 4 Nordic countries. J Infect Dis. 2007;196:1447-1454.
5. Woodhall S, Ramsey T, Cai C, et al. Estimation of the impact of genital warts on health-related quality of life. Sex Transm Infect. 2008;84:161-166.
6. Mortensen GL, Larsen HK. The quality of life of patients with genital warts: a qualitative study. BMC Public Health. 2010;10:113.
7. Wang KL, Jeng CJ, Yang YC, et al. The psychological impact of illness among women experiencing human papillomavirus-related illness or screening interventions. J Psychsom Obstet Gynaecol. 2010;31:16-23.
8. Lawrence S, Walzman M, Sheppard S, et al. The psychological impact caused by genital warts: has the Department of Health’s choice of vaccination missed the opportunity to prevent such morbidity? Int J STD AIDS. 2009;20:696-700.
9. Winer RL, Kiviat NB, Hughes JP, et al. Development and duration of human papillomavirus lesions, after initial infection. J Infect Dis. 2005;191:731-738.
10. Centers for Disease Control and Prevention. Human papillomavirus: HPV information for clinicians. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; April 2007.
11. Forcier M, Musacchio N. An overview of human papillomavirus infection for the dermatologist: disease, diagnosis, management, and prevention. Dermatol Ther. 2010;23:458-476.
12. Scheinfeld N, Lehman DS. An evidence-based review of medical and surgical treatments of genital warts. Dermatol Online J. 2006;12:5.
13. Aldara [package insert]. Bristol, TN: Graceway Pharmaceuticals, LLC; 2010.
14. Komericki P, Akkilic-Materna M, Strimitzer T, et al. Efficacy and safety of imiquimod versus podophyllotoxin in the treatment of genital warts. Sex Transm Dis. 2011;38:216-218.
15. Beutner KR, Tyring SK, Trofatter KF Jr, et al. Imiquimod, a patient-applied immune-response modifier for treatment of external genital warts. Antimicrob Agents Chemother. 1998;42:789-794.
16. Beutner KR, Spruance SL, Hougham AJ, et al. Treatment of genital warts with an immune-response modifier (imiquimod). J Am Acad Dermatol. 1998;38:230-239.
17. Edwards L, Ferenczy A, Eron L, et al. Self-administered topical 5% imiquimod cream for external anogenital warts. Arch Dermatol. 1998;134:25-30.
18. Fife KH, Ferenczy A, Douglas JM, et al. Treatment of external genital warts in men using 5% imiquimod cream applied three times a week, once daily, twice daily, or three times a day. Sex Transm Dis. 2001;28:226-231.
19. Garland SM, Waddell R, Mindel A, et al. An open-label phase II pilot study investigating the optimal duration of imiquimod 5% cream for the treatment of external genital warts in women. Int J STD AIDS. 2006;17:448-452.
20. Schofer H, Van Ophoven A, Henke U, et al. Randomized, comparative trial on the sustained efficacy of topical imiquimod 5% cream versus conventional ablative methods in external anogenital warts. Eur J Dermatol. 2006;16:642-648.
21. Arican O, Guneri F, Bilgic K, et al. Topical imiquimod 5% cream in external anogenital warts: a randomized, double-blind, placebo-controlled study. J Dermatol. 2004;31:627-631.
22. Gollnick H, Barasso R, Jappe U, et al. Safety and efficacy of imiquimod 5% cream in the treatment of penile genital warts in uncircumcised men when applied three times weekly or once per day. Int J STD AIDS. 2001;12:22-28.
23. Trofatter KF Jr, Ferenczy A, Fife KH. Increased frequency of dosing of imiquimod 5% cream in the treatment of external genital warts in women. Int J Gynecol Obstet. 2002;76:191-193.
24. Baker DA, Ferris DG, Martens MG, et al. Imiquimod 3.75% cream applied daily to treat anogenital warts: combined results from women in two randomized, placebo-controlled studies [published online ahead of print August 24, 2011]. Infect Dis Obstet Gynecol. 2011;2011:806105.
25. Dinh TH, Sternberg M, Dunne EF, et al. Genital warts among 18- to 59-year-olds in the US, National Health and Nutrition Examination Survey, 1999-2004. Sex Transm Dis. 2008;35:357-360.
26. Insinga RP, Dasbach EJ, Elbasha EH. Assessing the annual economic burden of preventing and treating anogenital human papillomavirus-related disease in the US: analytic framework and review of the literature. Pharmacoeconomics. 2005;23:1107-1122.
27. Koshiol JE, Laurent SA, Pimenta JM. Rate and predictors of new genital warts claims and genital warts-related healthcare utilization among privately insured patients in the United States. Sex Transm Dis. 2004;31:748-752.
28. Insinga RP, Glass AG, Rush BB. The health care costs of cervical human papillomavirus-related disease. Am J Obstet Gynecol. 2004;191:114-120.
External genital warts (EGWs), which are caused by infection with select types of human papillomavirus (HPV), are one of the most prevalent and fastest growing sexually transmitted infections.1 External genital warts affect approximately 1% of sexually active adults in the United States and Europe, with another 15% having subclinical infections; more than 1 million new cases of EGWs are diagnosed annually.2-4 Although the condition is not life threatening, lesions can cause symptoms, such as burning, itching, bleeding, pain and dyspareunia, and potential urethral or rectal obstruction. External genital warts also have been associated with adverse psychological effects.5-8
The time between exposure to HPV and development of EGWs can vary from a few weeks to several months or years (median, 2.9 months).9 Many HPV infections are mild and transient, resolving spontaneously.10 As many as 30% of EGWs will regress over 4 months and approximately 90% clear within 2 years.11,12 However, even with treatment, the median time to resolution is 5.9 months.9
Imiquimod cream 5%, which has been successfully used to treat EGWs since it was approved by the US Food and Drug Administration in 1997, is applied to lesions 3 times weekly at bedtime until clearance is achieved or for a maximum of 16 weeks.13 In clinical studies, complete clearance has been reported in 35% to 75% of participants.14-21 However, it is important to note that not all anogenital regions with warts were required to be treated in these studies,14-21 and newly arising warts were not included in the analysis.17 Reported clearance rates were higher and median clearance time was shorter in women.17 Relatively low recurrence rates (6%–26%) have been reported after successful clearance of EGWs.16,17,20,21
Long treatment durations are always a concern for patient adherence. Although increasing the dosing frequency with imiquimod cream 5% might be considered an attractive option to reduce the length of the treatment course, it has resulted in greater incidence and severity of local adverse events (AEs) in some studies without improved efficacy.18,22,23 Thus lower concentrations of imiquimod (ie, 2.5% and 3.75% formulations) were developed to potentially decrease treatment duration and provide a daily dosing regimen.
We report the results of 2 identical, placebo-controlled, phase 3 studies evaluating the safety and efficacy of imiquimod cream 2.5% and 3.75% in treating EGWs in men. Pooled results from a female subgroup previously have been reported.24 Although the percentage of women who reported ever being diagnosed with EGWs was higher than in men (7.2% vs 4%) in one survey,25 other assessments have found a similar prevalence of EGWs among both genders.26-28 We provide important insights herein by reporting efficacy and tolerability data for imiquimod cream 2.5% and 3.75% in the treatment of EGWs in males.
Methods
Study Design
Male patients aged 12 years and older with 2 to 30 EGWs in the inguinal, perineal, and/or perianal areas as well as on the glans penis, penile shaft, scrotum, and/or foreskin were enrolled in 2 identical, multicenter, randomized, parallel-group, double-blind, placebo-controlled studies. Participants were randomized (2:2:1) to self-treatment with imiquimod cream 3.75% or 2.5% or placebo once daily until complete clearance was achieved or for a maximum of 8 weeks (end of treatment [EOT]). There was a follow-up period of up to 8 weeks (end of study [EOS]) in participants who did not achieve complete clearance by EOT. All participants who achieved complete clearance by EOS entered a 12-week observational follow-up period to assess recurrence.
Primary and Secondary Efficacy Criteria
The primary efficacy end point was complete clearance rate, which was defined as the proportion of participants by the EOS visit with zero EGWs (that either existed at baseline and any warts developing during the study) in all anogenital anatomic areas. It is important to note that this primary efficacy end point was very conservative in that it included any new warts occurring during the study that may not have received a full treatment course. Lesions were counted in all assessed anatomic areas without distinction between those that were identified at baseline or those that were newly identified during the study period. If new EGWs appeared during the study in new anatomic areas, such lesions were treated with the study medication as they appeared. Therefore, any newly arising EGWs received less than the full course of treatment, as therapy was not extended beyond the 8-week study period. Participants were evaluated for the presence of any EGWs in all anatomic areas without distinction between lesions that were present at baseline and newly arising EGWs. Therefore, development of new EGWs during the study period could potentially lower clearance rates.
Secondary end points were 75% or more and 50% or more reduction in EGW count, change in EGW count from baseline, and 12-week sustained clearance rate.
Safety
Safety assessments of AEs, both volunteered and elicited, were made throughout the study.
Study Oversight
The study was conducted in accordance with the ethical principles specified in the Declaration of Helsinki and in compliance with the requirements of local regulatory committees. All participants provided written informed consent.
Statistical Analysis
Statistical analysis for intention-to-treat (ITT) imputations was made for missing data points using last observation carried forward (LOCF). Complete clearance rates and partial clearance rates were analyzed using Cochran-Mantel-Haenszel statistics stratified by center and by gender for the overall population analyses. The percentage change in EGW count was analyzed using analysis of covariance. All statistical analyses were performed using SAS software (version 9.1.3).
Results
Study Population
Study characteristics by treatment group are summarized in the Table. Overall, 447 male participants (225 from study 1 and 222 from study 2) were included in the study. The majority of participants (84.1%) had EGWs on the penile shaft with only 1 affected region in just over half of participants (51.9%). Most participants (70.2%) were 35 years or younger, and approximately half had a baseline EGW count of 7 or less (50.6%). More than 20% of participants had an affected wart surface area greater than 150 mm2 at baseline, and in more than 60% of participants, the duration from first diagnosis of EGWs to enrollment in the study was more than 1 year.
Primary Efficacy End Point
Imiquimod cream 3.75% was statistically superior to placebo in study 1 and study 2 (P=.015 and P=.019, respectively)(Figure) in providing complete clearance of all EGWs (baseline or new) at EOS. Imiquimod cream 2.5% was only statistically superior to placebo in study 2 (P=.034). Importantly, there were a number of participants who did not achieve complete clearance at EOT who continued to improve posttreatment. The percentage of participants treated with imiquimod cream 3.75% and 2.5% who were completely cleared at EOT was 12.0% (14.7% study 1 and 9.1% study 2) and 7.1% (7.2% study 1 and 7.1% study 2), respectively, compared to complete clearance rates of 18.6% (20.0% study 1 and 17.0% study 2) and 14.3% (13.3% study 1 and 15.3% study 2), respectively, at EOS (ITT population).
|
|
Complete clearance rates (defined as the proportion of participants by the end-of-study [EOS] visit with zero external genital warts in all anogenital anatomic areas) in the intention-to-treat (ITT) population (last observation carried forward [LOCF])(A) and per-protocol (PP) population (OC [observed case])(B), including both individual and pooled study data. |
In both studies complete clearance rates were significantly higher (P<.019 both studies) with imiquimod cream 3.75% compared with placebo at weeks 10 through 16 (EOS). In study 2, complete clearance rates were significantly higher (P<.049) with imiquimod cream 2.5% compared to placebo from week 14 to week 16 (EOS). Complete clearance rates were highest in participants treated with imiquimod cream 3.75% who had EGWs in the perianal region or on the glans penis (28.6% and 33.3%, respectively); however, the number of participants in both groups was relatively small.
Overall, 18.8% of participants took rest periods. Complete clearance rates were higher in men who took a rest period (26.5% and 27.3% for imiquimod cream 3.75% and 2.5%, respectively), perhaps reflecting a more brisk immunological response. The frequency, duration, and number of dosing days prior to the rest period were similar in the active treatment groups and lower in the placebo group.
There was a tendency for older participants (ie, >35 years) and those with lower baseline EGW counts (ie, ≤7) to respond better. Participants treated with imiquimod cream 3.75% also tended to respond best to treatment when only 1 anatomic area was affected.
Secondary Efficacy End Points
The proportion of male participants with at least a 75% reduction in EGW count from baseline at EOS was statistically superior with imiquimod 3.75% compared to placebo in study 1 and study 2 (P=.001 and P=.008, respectively). Statistical superiority also was apparent with imiquimod cream 2.5% versus placebo in study 2 (P=.013). Overall, 20.2% (18.1% study 1 and 22.4% study 2) and 27.3% (30.5% study 1 and 23.9% study 2) of participants achieved at least a 75% reduction in wart count at EOS with imiquimod cream 2.5% and 3.75%, respectively (pooled data).
Percentage change in EGW count from baseline at EOS was 35.8% and 24.1% with imiquimod cream 3.75% in study 1 and study 2, respectively, both significantly better than placebo (P=.002 and P=.011, respectively). Change in EGW count following treatment with imiquimod cream 2.5% was only significant in study 2 (P=.001).
The median time to complete clearance was shorter in the 2 active treatment groups compared with placebo. For those participants who attained complete clearance, the median time to complete clearance ranged from 57 to 59 days in the imiquimod cream 3.75% groups (studies 1 and 2, respectively), 60 to 74 days in the imiquimod 2.5% cream groups (studies 1 and 2, respectively), and 76 to 81 days with placebo (studies 2 and 1, respectively).
Safety
Less than one-third of male participants in each treatment group experienced AEs during the studies. The incidence of serious adverse events (SAEs) and AEs leading to study discontinuation was low. In total, 4 participants (0.9% [3 in the imiquimod cream 2.5% group and 1 in the imiquimod cream 3.75% group]) had AEs that led to study discontinuation. Application-site reactions were reported in a total of 46 participants (10.3%). The incidence and severity of local skin reactions was mostly mild or moderate, similar in both active treatment groups, and higher than in the placebo group. Local skin reactions were coincident with the treatment period and rapidly decreased when treatment was concluded. There were no clinically meaningful trends in vital sign measurements or laboratory measurements.
Comment
Imiquimod cream 5% has been shown to be a safe and effective treatment of EGWs. Our study was designed to evaluate lower concentrations of imiquimod cream (2.5% and 3.75%), which may permit daily dosing and a shortened treatment course in men with EGWs.
Efficacy of imiquimod cream 2.5% and 3.75% was established through both primary and secondary end points, though only the higher concentration was significantly more effective than placebo in both studies. In addition, a number of participants who were not completely cleared following 8 weeks of treatment went on to be completely cleared at EOS, demonstrating continued activity of imiquimod despite cessation of active treatment.
Imiquimod cream 3.75% was particularly effective when compared to placebo, with 18.6% of participants completely cleared at EOS, though the PP (observed case) results (22.7%) may be more encouraging and can be used to motivate patients.
Although there are limitations in making direct comparisons between studies, complete clearance rates in our studies were lower than those reported previously with imiquimod cream 5%.17 Lower efficacy rates might be expected given the differences in methodology. In the 2 studies reported here, participants had to have no EGWs (baseline or new, treated or untreated) in any of the anogenital areas specified to be reported as having achieved complete clearance. In earlier studies with imiquimod cream 5%, not all anogenital regions were required to be treated, and any new EGWs arising during treatment were not included in the analysis.17 Also, our analysis focused purely on a male patient population in which efficacy results tend to be lower regardless of treatment modality employed.
Recurrence is another important issue in the treatment of EGWs. Although not studied specifically in a male population, recurrence rates of 16.7% to 17.7% were seen in the 3 months following successful treatment with imiquimod cream 2.5% and 3.75% in the 2 pivotal studies. These results were consistent with the recurrence rates reported following successful treatment with imiquimod cream 5%.17
In general, complete clearance rates increased in a dose-dependent manner. Complete clearance rates were lower in the male subpopulation across all treatment groups compared to those previously reported in females,24 which was consistent with prior results reported for imiquimod cream 5% as well as other topical treatments.17 It has been suggested that this difference may be due in part to the distribution of female EGWs in areas of less keratinization. Complete clearance rates in the current analysis tended to be higher in male participants with baseline EGWs in anatomic sites with less keratinized skin such as the perianal, perineal, or glans penis areas.
Daily application of imiquimod cream 2.5% and 3.75% generally was well tolerated. Most reported AEs were mild or moderate, and few participants discontinued because of AEs. Few SAEs were reported and none were considered to be treatment related. There was no difference in the incidence rates of AEs between the 2 active treatments. The incidence of SAEs and study discontinuations was much lower than previously reported in the female cohort of these 2 studies.24
Conclusion
In conclusion, 2 well-controlled studies of males with EGWs who were treated for up to 8 weeks with imiquimod cream 2.5% and 3.75% applied daily demonstrated good tolerability and superior efficacy to placebo in complete clearance of all baseline and newly arising warts in addition to reducing EGW counts.
Acknowledgments—The authors thank Christina Cognata Smith, PharmD, and Mandeep Kaur, MD (both previously of Valeant Pharmaceuticals North America, LLC, Bridgewater, New Jersey), as well as Brian Bulley, MSc (Inergy Limited, Lindfield, West Sussex, United Kingdom), for assistance with the preparation of the manuscript. Valeant Pharmaceuticals North America, LLC, funded Inergy’s activities pertaining to this analysis.
External genital warts (EGWs), which are caused by infection with select types of human papillomavirus (HPV), are one of the most prevalent and fastest growing sexually transmitted infections.1 External genital warts affect approximately 1% of sexually active adults in the United States and Europe, with another 15% having subclinical infections; more than 1 million new cases of EGWs are diagnosed annually.2-4 Although the condition is not life threatening, lesions can cause symptoms, such as burning, itching, bleeding, pain and dyspareunia, and potential urethral or rectal obstruction. External genital warts also have been associated with adverse psychological effects.5-8
The time between exposure to HPV and development of EGWs can vary from a few weeks to several months or years (median, 2.9 months).9 Many HPV infections are mild and transient, resolving spontaneously.10 As many as 30% of EGWs will regress over 4 months and approximately 90% clear within 2 years.11,12 However, even with treatment, the median time to resolution is 5.9 months.9
Imiquimod cream 5%, which has been successfully used to treat EGWs since it was approved by the US Food and Drug Administration in 1997, is applied to lesions 3 times weekly at bedtime until clearance is achieved or for a maximum of 16 weeks.13 In clinical studies, complete clearance has been reported in 35% to 75% of participants.14-21 However, it is important to note that not all anogenital regions with warts were required to be treated in these studies,14-21 and newly arising warts were not included in the analysis.17 Reported clearance rates were higher and median clearance time was shorter in women.17 Relatively low recurrence rates (6%–26%) have been reported after successful clearance of EGWs.16,17,20,21
Long treatment durations are always a concern for patient adherence. Although increasing the dosing frequency with imiquimod cream 5% might be considered an attractive option to reduce the length of the treatment course, it has resulted in greater incidence and severity of local adverse events (AEs) in some studies without improved efficacy.18,22,23 Thus lower concentrations of imiquimod (ie, 2.5% and 3.75% formulations) were developed to potentially decrease treatment duration and provide a daily dosing regimen.
We report the results of 2 identical, placebo-controlled, phase 3 studies evaluating the safety and efficacy of imiquimod cream 2.5% and 3.75% in treating EGWs in men. Pooled results from a female subgroup previously have been reported.24 Although the percentage of women who reported ever being diagnosed with EGWs was higher than in men (7.2% vs 4%) in one survey,25 other assessments have found a similar prevalence of EGWs among both genders.26-28 We provide important insights herein by reporting efficacy and tolerability data for imiquimod cream 2.5% and 3.75% in the treatment of EGWs in males.
Methods
Study Design
Male patients aged 12 years and older with 2 to 30 EGWs in the inguinal, perineal, and/or perianal areas as well as on the glans penis, penile shaft, scrotum, and/or foreskin were enrolled in 2 identical, multicenter, randomized, parallel-group, double-blind, placebo-controlled studies. Participants were randomized (2:2:1) to self-treatment with imiquimod cream 3.75% or 2.5% or placebo once daily until complete clearance was achieved or for a maximum of 8 weeks (end of treatment [EOT]). There was a follow-up period of up to 8 weeks (end of study [EOS]) in participants who did not achieve complete clearance by EOT. All participants who achieved complete clearance by EOS entered a 12-week observational follow-up period to assess recurrence.
Primary and Secondary Efficacy Criteria
The primary efficacy end point was complete clearance rate, which was defined as the proportion of participants by the EOS visit with zero EGWs (that either existed at baseline and any warts developing during the study) in all anogenital anatomic areas. It is important to note that this primary efficacy end point was very conservative in that it included any new warts occurring during the study that may not have received a full treatment course. Lesions were counted in all assessed anatomic areas without distinction between those that were identified at baseline or those that were newly identified during the study period. If new EGWs appeared during the study in new anatomic areas, such lesions were treated with the study medication as they appeared. Therefore, any newly arising EGWs received less than the full course of treatment, as therapy was not extended beyond the 8-week study period. Participants were evaluated for the presence of any EGWs in all anatomic areas without distinction between lesions that were present at baseline and newly arising EGWs. Therefore, development of new EGWs during the study period could potentially lower clearance rates.
Secondary end points were 75% or more and 50% or more reduction in EGW count, change in EGW count from baseline, and 12-week sustained clearance rate.
Safety
Safety assessments of AEs, both volunteered and elicited, were made throughout the study.
Study Oversight
The study was conducted in accordance with the ethical principles specified in the Declaration of Helsinki and in compliance with the requirements of local regulatory committees. All participants provided written informed consent.
Statistical Analysis
Statistical analysis for intention-to-treat (ITT) imputations was made for missing data points using last observation carried forward (LOCF). Complete clearance rates and partial clearance rates were analyzed using Cochran-Mantel-Haenszel statistics stratified by center and by gender for the overall population analyses. The percentage change in EGW count was analyzed using analysis of covariance. All statistical analyses were performed using SAS software (version 9.1.3).
Results
Study Population
Study characteristics by treatment group are summarized in the Table. Overall, 447 male participants (225 from study 1 and 222 from study 2) were included in the study. The majority of participants (84.1%) had EGWs on the penile shaft with only 1 affected region in just over half of participants (51.9%). Most participants (70.2%) were 35 years or younger, and approximately half had a baseline EGW count of 7 or less (50.6%). More than 20% of participants had an affected wart surface area greater than 150 mm2 at baseline, and in more than 60% of participants, the duration from first diagnosis of EGWs to enrollment in the study was more than 1 year.
Primary Efficacy End Point
Imiquimod cream 3.75% was statistically superior to placebo in study 1 and study 2 (P=.015 and P=.019, respectively)(Figure) in providing complete clearance of all EGWs (baseline or new) at EOS. Imiquimod cream 2.5% was only statistically superior to placebo in study 2 (P=.034). Importantly, there were a number of participants who did not achieve complete clearance at EOT who continued to improve posttreatment. The percentage of participants treated with imiquimod cream 3.75% and 2.5% who were completely cleared at EOT was 12.0% (14.7% study 1 and 9.1% study 2) and 7.1% (7.2% study 1 and 7.1% study 2), respectively, compared to complete clearance rates of 18.6% (20.0% study 1 and 17.0% study 2) and 14.3% (13.3% study 1 and 15.3% study 2), respectively, at EOS (ITT population).
|
|
Complete clearance rates (defined as the proportion of participants by the end-of-study [EOS] visit with zero external genital warts in all anogenital anatomic areas) in the intention-to-treat (ITT) population (last observation carried forward [LOCF])(A) and per-protocol (PP) population (OC [observed case])(B), including both individual and pooled study data. |
In both studies complete clearance rates were significantly higher (P<.019 both studies) with imiquimod cream 3.75% compared with placebo at weeks 10 through 16 (EOS). In study 2, complete clearance rates were significantly higher (P<.049) with imiquimod cream 2.5% compared to placebo from week 14 to week 16 (EOS). Complete clearance rates were highest in participants treated with imiquimod cream 3.75% who had EGWs in the perianal region or on the glans penis (28.6% and 33.3%, respectively); however, the number of participants in both groups was relatively small.
Overall, 18.8% of participants took rest periods. Complete clearance rates were higher in men who took a rest period (26.5% and 27.3% for imiquimod cream 3.75% and 2.5%, respectively), perhaps reflecting a more brisk immunological response. The frequency, duration, and number of dosing days prior to the rest period were similar in the active treatment groups and lower in the placebo group.
There was a tendency for older participants (ie, >35 years) and those with lower baseline EGW counts (ie, ≤7) to respond better. Participants treated with imiquimod cream 3.75% also tended to respond best to treatment when only 1 anatomic area was affected.
Secondary Efficacy End Points
The proportion of male participants with at least a 75% reduction in EGW count from baseline at EOS was statistically superior with imiquimod 3.75% compared to placebo in study 1 and study 2 (P=.001 and P=.008, respectively). Statistical superiority also was apparent with imiquimod cream 2.5% versus placebo in study 2 (P=.013). Overall, 20.2% (18.1% study 1 and 22.4% study 2) and 27.3% (30.5% study 1 and 23.9% study 2) of participants achieved at least a 75% reduction in wart count at EOS with imiquimod cream 2.5% and 3.75%, respectively (pooled data).
Percentage change in EGW count from baseline at EOS was 35.8% and 24.1% with imiquimod cream 3.75% in study 1 and study 2, respectively, both significantly better than placebo (P=.002 and P=.011, respectively). Change in EGW count following treatment with imiquimod cream 2.5% was only significant in study 2 (P=.001).
The median time to complete clearance was shorter in the 2 active treatment groups compared with placebo. For those participants who attained complete clearance, the median time to complete clearance ranged from 57 to 59 days in the imiquimod cream 3.75% groups (studies 1 and 2, respectively), 60 to 74 days in the imiquimod 2.5% cream groups (studies 1 and 2, respectively), and 76 to 81 days with placebo (studies 2 and 1, respectively).
Safety
Less than one-third of male participants in each treatment group experienced AEs during the studies. The incidence of serious adverse events (SAEs) and AEs leading to study discontinuation was low. In total, 4 participants (0.9% [3 in the imiquimod cream 2.5% group and 1 in the imiquimod cream 3.75% group]) had AEs that led to study discontinuation. Application-site reactions were reported in a total of 46 participants (10.3%). The incidence and severity of local skin reactions was mostly mild or moderate, similar in both active treatment groups, and higher than in the placebo group. Local skin reactions were coincident with the treatment period and rapidly decreased when treatment was concluded. There were no clinically meaningful trends in vital sign measurements or laboratory measurements.
Comment
Imiquimod cream 5% has been shown to be a safe and effective treatment of EGWs. Our study was designed to evaluate lower concentrations of imiquimod cream (2.5% and 3.75%), which may permit daily dosing and a shortened treatment course in men with EGWs.
Efficacy of imiquimod cream 2.5% and 3.75% was established through both primary and secondary end points, though only the higher concentration was significantly more effective than placebo in both studies. In addition, a number of participants who were not completely cleared following 8 weeks of treatment went on to be completely cleared at EOS, demonstrating continued activity of imiquimod despite cessation of active treatment.
Imiquimod cream 3.75% was particularly effective when compared to placebo, with 18.6% of participants completely cleared at EOS, though the PP (observed case) results (22.7%) may be more encouraging and can be used to motivate patients.
Although there are limitations in making direct comparisons between studies, complete clearance rates in our studies were lower than those reported previously with imiquimod cream 5%.17 Lower efficacy rates might be expected given the differences in methodology. In the 2 studies reported here, participants had to have no EGWs (baseline or new, treated or untreated) in any of the anogenital areas specified to be reported as having achieved complete clearance. In earlier studies with imiquimod cream 5%, not all anogenital regions were required to be treated, and any new EGWs arising during treatment were not included in the analysis.17 Also, our analysis focused purely on a male patient population in which efficacy results tend to be lower regardless of treatment modality employed.
Recurrence is another important issue in the treatment of EGWs. Although not studied specifically in a male population, recurrence rates of 16.7% to 17.7% were seen in the 3 months following successful treatment with imiquimod cream 2.5% and 3.75% in the 2 pivotal studies. These results were consistent with the recurrence rates reported following successful treatment with imiquimod cream 5%.17
In general, complete clearance rates increased in a dose-dependent manner. Complete clearance rates were lower in the male subpopulation across all treatment groups compared to those previously reported in females,24 which was consistent with prior results reported for imiquimod cream 5% as well as other topical treatments.17 It has been suggested that this difference may be due in part to the distribution of female EGWs in areas of less keratinization. Complete clearance rates in the current analysis tended to be higher in male participants with baseline EGWs in anatomic sites with less keratinized skin such as the perianal, perineal, or glans penis areas.
Daily application of imiquimod cream 2.5% and 3.75% generally was well tolerated. Most reported AEs were mild or moderate, and few participants discontinued because of AEs. Few SAEs were reported and none were considered to be treatment related. There was no difference in the incidence rates of AEs between the 2 active treatments. The incidence of SAEs and study discontinuations was much lower than previously reported in the female cohort of these 2 studies.24
Conclusion
In conclusion, 2 well-controlled studies of males with EGWs who were treated for up to 8 weeks with imiquimod cream 2.5% and 3.75% applied daily demonstrated good tolerability and superior efficacy to placebo in complete clearance of all baseline and newly arising warts in addition to reducing EGW counts.
Acknowledgments—The authors thank Christina Cognata Smith, PharmD, and Mandeep Kaur, MD (both previously of Valeant Pharmaceuticals North America, LLC, Bridgewater, New Jersey), as well as Brian Bulley, MSc (Inergy Limited, Lindfield, West Sussex, United Kingdom), for assistance with the preparation of the manuscript. Valeant Pharmaceuticals North America, LLC, funded Inergy’s activities pertaining to this analysis.
1. Weinstock H, Berman S, Cates W. Sexually transmitted infections in American youth: incidence and prevalence estimates, 2000. Perspect Sex Reprod Health. 2004;36:6-10.
2. Dunne EF, Unger ER, Sternberg M, et al. Prevalence of HPV infection among females in the United States. JAMA. 2007;297:813-819.
3. Koutsky L. Epidemiology of genital human papillomavirus infection. Am J Med. 1997;102:3-8.
4. Kjaer SK, Tran TN, Sparen P, et al. The burden of genital warts: a study of nearly 70,000 women from the general female population in the 4 Nordic countries. J Infect Dis. 2007;196:1447-1454.
5. Woodhall S, Ramsey T, Cai C, et al. Estimation of the impact of genital warts on health-related quality of life. Sex Transm Infect. 2008;84:161-166.
6. Mortensen GL, Larsen HK. The quality of life of patients with genital warts: a qualitative study. BMC Public Health. 2010;10:113.
7. Wang KL, Jeng CJ, Yang YC, et al. The psychological impact of illness among women experiencing human papillomavirus-related illness or screening interventions. J Psychsom Obstet Gynaecol. 2010;31:16-23.
8. Lawrence S, Walzman M, Sheppard S, et al. The psychological impact caused by genital warts: has the Department of Health’s choice of vaccination missed the opportunity to prevent such morbidity? Int J STD AIDS. 2009;20:696-700.
9. Winer RL, Kiviat NB, Hughes JP, et al. Development and duration of human papillomavirus lesions, after initial infection. J Infect Dis. 2005;191:731-738.
10. Centers for Disease Control and Prevention. Human papillomavirus: HPV information for clinicians. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; April 2007.
11. Forcier M, Musacchio N. An overview of human papillomavirus infection for the dermatologist: disease, diagnosis, management, and prevention. Dermatol Ther. 2010;23:458-476.
12. Scheinfeld N, Lehman DS. An evidence-based review of medical and surgical treatments of genital warts. Dermatol Online J. 2006;12:5.
13. Aldara [package insert]. Bristol, TN: Graceway Pharmaceuticals, LLC; 2010.
14. Komericki P, Akkilic-Materna M, Strimitzer T, et al. Efficacy and safety of imiquimod versus podophyllotoxin in the treatment of genital warts. Sex Transm Dis. 2011;38:216-218.
15. Beutner KR, Tyring SK, Trofatter KF Jr, et al. Imiquimod, a patient-applied immune-response modifier for treatment of external genital warts. Antimicrob Agents Chemother. 1998;42:789-794.
16. Beutner KR, Spruance SL, Hougham AJ, et al. Treatment of genital warts with an immune-response modifier (imiquimod). J Am Acad Dermatol. 1998;38:230-239.
17. Edwards L, Ferenczy A, Eron L, et al. Self-administered topical 5% imiquimod cream for external anogenital warts. Arch Dermatol. 1998;134:25-30.
18. Fife KH, Ferenczy A, Douglas JM, et al. Treatment of external genital warts in men using 5% imiquimod cream applied three times a week, once daily, twice daily, or three times a day. Sex Transm Dis. 2001;28:226-231.
19. Garland SM, Waddell R, Mindel A, et al. An open-label phase II pilot study investigating the optimal duration of imiquimod 5% cream for the treatment of external genital warts in women. Int J STD AIDS. 2006;17:448-452.
20. Schofer H, Van Ophoven A, Henke U, et al. Randomized, comparative trial on the sustained efficacy of topical imiquimod 5% cream versus conventional ablative methods in external anogenital warts. Eur J Dermatol. 2006;16:642-648.
21. Arican O, Guneri F, Bilgic K, et al. Topical imiquimod 5% cream in external anogenital warts: a randomized, double-blind, placebo-controlled study. J Dermatol. 2004;31:627-631.
22. Gollnick H, Barasso R, Jappe U, et al. Safety and efficacy of imiquimod 5% cream in the treatment of penile genital warts in uncircumcised men when applied three times weekly or once per day. Int J STD AIDS. 2001;12:22-28.
23. Trofatter KF Jr, Ferenczy A, Fife KH. Increased frequency of dosing of imiquimod 5% cream in the treatment of external genital warts in women. Int J Gynecol Obstet. 2002;76:191-193.
24. Baker DA, Ferris DG, Martens MG, et al. Imiquimod 3.75% cream applied daily to treat anogenital warts: combined results from women in two randomized, placebo-controlled studies [published online ahead of print August 24, 2011]. Infect Dis Obstet Gynecol. 2011;2011:806105.
25. Dinh TH, Sternberg M, Dunne EF, et al. Genital warts among 18- to 59-year-olds in the US, National Health and Nutrition Examination Survey, 1999-2004. Sex Transm Dis. 2008;35:357-360.
26. Insinga RP, Dasbach EJ, Elbasha EH. Assessing the annual economic burden of preventing and treating anogenital human papillomavirus-related disease in the US: analytic framework and review of the literature. Pharmacoeconomics. 2005;23:1107-1122.
27. Koshiol JE, Laurent SA, Pimenta JM. Rate and predictors of new genital warts claims and genital warts-related healthcare utilization among privately insured patients in the United States. Sex Transm Dis. 2004;31:748-752.
28. Insinga RP, Glass AG, Rush BB. The health care costs of cervical human papillomavirus-related disease. Am J Obstet Gynecol. 2004;191:114-120.
1. Weinstock H, Berman S, Cates W. Sexually transmitted infections in American youth: incidence and prevalence estimates, 2000. Perspect Sex Reprod Health. 2004;36:6-10.
2. Dunne EF, Unger ER, Sternberg M, et al. Prevalence of HPV infection among females in the United States. JAMA. 2007;297:813-819.
3. Koutsky L. Epidemiology of genital human papillomavirus infection. Am J Med. 1997;102:3-8.
4. Kjaer SK, Tran TN, Sparen P, et al. The burden of genital warts: a study of nearly 70,000 women from the general female population in the 4 Nordic countries. J Infect Dis. 2007;196:1447-1454.
5. Woodhall S, Ramsey T, Cai C, et al. Estimation of the impact of genital warts on health-related quality of life. Sex Transm Infect. 2008;84:161-166.
6. Mortensen GL, Larsen HK. The quality of life of patients with genital warts: a qualitative study. BMC Public Health. 2010;10:113.
7. Wang KL, Jeng CJ, Yang YC, et al. The psychological impact of illness among women experiencing human papillomavirus-related illness or screening interventions. J Psychsom Obstet Gynaecol. 2010;31:16-23.
8. Lawrence S, Walzman M, Sheppard S, et al. The psychological impact caused by genital warts: has the Department of Health’s choice of vaccination missed the opportunity to prevent such morbidity? Int J STD AIDS. 2009;20:696-700.
9. Winer RL, Kiviat NB, Hughes JP, et al. Development and duration of human papillomavirus lesions, after initial infection. J Infect Dis. 2005;191:731-738.
10. Centers for Disease Control and Prevention. Human papillomavirus: HPV information for clinicians. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; April 2007.
11. Forcier M, Musacchio N. An overview of human papillomavirus infection for the dermatologist: disease, diagnosis, management, and prevention. Dermatol Ther. 2010;23:458-476.
12. Scheinfeld N, Lehman DS. An evidence-based review of medical and surgical treatments of genital warts. Dermatol Online J. 2006;12:5.
13. Aldara [package insert]. Bristol, TN: Graceway Pharmaceuticals, LLC; 2010.
14. Komericki P, Akkilic-Materna M, Strimitzer T, et al. Efficacy and safety of imiquimod versus podophyllotoxin in the treatment of genital warts. Sex Transm Dis. 2011;38:216-218.
15. Beutner KR, Tyring SK, Trofatter KF Jr, et al. Imiquimod, a patient-applied immune-response modifier for treatment of external genital warts. Antimicrob Agents Chemother. 1998;42:789-794.
16. Beutner KR, Spruance SL, Hougham AJ, et al. Treatment of genital warts with an immune-response modifier (imiquimod). J Am Acad Dermatol. 1998;38:230-239.
17. Edwards L, Ferenczy A, Eron L, et al. Self-administered topical 5% imiquimod cream for external anogenital warts. Arch Dermatol. 1998;134:25-30.
18. Fife KH, Ferenczy A, Douglas JM, et al. Treatment of external genital warts in men using 5% imiquimod cream applied three times a week, once daily, twice daily, or three times a day. Sex Transm Dis. 2001;28:226-231.
19. Garland SM, Waddell R, Mindel A, et al. An open-label phase II pilot study investigating the optimal duration of imiquimod 5% cream for the treatment of external genital warts in women. Int J STD AIDS. 2006;17:448-452.
20. Schofer H, Van Ophoven A, Henke U, et al. Randomized, comparative trial on the sustained efficacy of topical imiquimod 5% cream versus conventional ablative methods in external anogenital warts. Eur J Dermatol. 2006;16:642-648.
21. Arican O, Guneri F, Bilgic K, et al. Topical imiquimod 5% cream in external anogenital warts: a randomized, double-blind, placebo-controlled study. J Dermatol. 2004;31:627-631.
22. Gollnick H, Barasso R, Jappe U, et al. Safety and efficacy of imiquimod 5% cream in the treatment of penile genital warts in uncircumcised men when applied three times weekly or once per day. Int J STD AIDS. 2001;12:22-28.
23. Trofatter KF Jr, Ferenczy A, Fife KH. Increased frequency of dosing of imiquimod 5% cream in the treatment of external genital warts in women. Int J Gynecol Obstet. 2002;76:191-193.
24. Baker DA, Ferris DG, Martens MG, et al. Imiquimod 3.75% cream applied daily to treat anogenital warts: combined results from women in two randomized, placebo-controlled studies [published online ahead of print August 24, 2011]. Infect Dis Obstet Gynecol. 2011;2011:806105.
25. Dinh TH, Sternberg M, Dunne EF, et al. Genital warts among 18- to 59-year-olds in the US, National Health and Nutrition Examination Survey, 1999-2004. Sex Transm Dis. 2008;35:357-360.
26. Insinga RP, Dasbach EJ, Elbasha EH. Assessing the annual economic burden of preventing and treating anogenital human papillomavirus-related disease in the US: analytic framework and review of the literature. Pharmacoeconomics. 2005;23:1107-1122.
27. Koshiol JE, Laurent SA, Pimenta JM. Rate and predictors of new genital warts claims and genital warts-related healthcare utilization among privately insured patients in the United States. Sex Transm Dis. 2004;31:748-752.
28. Insinga RP, Glass AG, Rush BB. The health care costs of cervical human papillomavirus-related disease. Am J Obstet Gynecol. 2004;191:114-120.
Practice Points
- Imiquimod cream, both 2.5% and 3.75% concentrations, is more effective than placebo in treating external genital warts (EGWs) in men.
- Imiquimod cream, in both concentrations tested, is somewhat less effective in men than in women in the same protocol.
- Imiquimod cream treatment of EGWs is better tolerated in men than in women in the same protocol.
Tolerance of Fragranced and Fragrance-Free Facial Cleansers in Adults With Clinically Sensitive Skin
For thousands of years, humans have used fragrances to change or affect their mood and enhance an “aura of beauty.”1 Fragrance is a primary driver in consumer choice and purchasing decisions, especially when considering personal care products.2 In addition to fragrance, consumers choose cleanser products based on compatibility with skin, cleansing properties, and sensory attributes such as viscosity and foaming.3,4 However, fragrance sensitivity is among the most common causes of allergic contact dermatitis from cosmetics and personal care products,5 and estimates of the prevalence of fragrance sensitivity range from 1.8% to 4.2%.6
A panel of 26 fragrance ingredients that frequently induce contact dermatitis in sensitive individuals has been identified.7 Since 2003, regulatory authorities in the European Union require these compounds to be listed on the labels of consumer products to protect presensitized consumers.7,8 However, manufacturers of cosmetics are not required to specify allergenic fragrance ingredients outside the European Union, and therefore it is difficult for consumers in the United States to avoid fragrance allergens.
Creation of a fragranced product for fragrance-sensitive individuals begins with careful selection of ingredients and extensive formulation testing and evaluation. This process usually is followed by testing in normal individuals to confirm that the fragranced product is well accepted and then evaluation is done in clinically confirmed fragrance-sensitive patients and those with a compromised skin barrier from atopic dermatitis, rosacea, or eczema.
Sensitive skin may be due to increased immune responsiveness, altered neurosensory input, and/or decreased skin barrier function, and presents a complex challenge for dermatologists.9 Subjective perceptions of sensitive skin include stinging, burning, pruritus, and tightness following product application. Clinically sensitive skin is defined by the presence of erythema, stratum corneum desquamation, papules, pustules, wheals, vesicles, bullae, and/or erosions.9 Although some of these symptoms may be observed immediately, others may be delayed by minutes, hours, or days following the use of an irritating product. Patients who present with subjective symptoms of sensitive skin may or may not show objective symptoms.
Gentle skin cleansing is particularly important for patients with compromised skin barrier integrity, such as those with acne, atopic dermatitis, eczema, or rosacea. Standard alkaline surfactants in skin cleansers help to remove dirt and oily soil and produce lather but can impair the skin barrier function and facilitate development of irritation.10-13 The tolerability of a cleanser is influenced by its pH, the type and amount of surfactant ingredients, the presence of moisturizing agents, and the amount of residue left on the skin after washing.11,12 Mild cleansers have been developed for patients with sensitive skin conditions and are expected to provide cleansing benefits without negatively affecting the hydration and viscoelastic properties of skin.11 Mild cleansers interact minimally with skin proteins and lipids because they usually contain nonionic synthetic surfactant mixtures; they also have a pH value close to the slightly acidic pH of normal skin, contain moisturizing agents,11,14,15 and usually produce less foam.10,16 In patients with sensitive skin, mild and fragrance-free cleansers often are recommended.17,18 Because fragrances often affect consumers’ perception of product performance19 and enhance the cleaning experience of the user, consumer compliance with clinical recommendations to use fragrance-free cleansers often is poor.
Low–molecular-weight, water-soluble, hydrophobically modified polymers (HMPs) have been used to create gentle foaming cleansers with reduced impact on the skin barrier.12,16,20 In the presence of HMPs, surfactants assemble into larger, more stable polymer-surfactant structures that are less likely to penetrate the skin.16 Hydrophobically modified polymers can potentially reduce skin irritation by lowering the concentration of free micelles in solution. Additionally, both HMPs and HMP-surfactant complexes stabilize newly formed air-water interfaces, leading to thicker, denser, and longer-lasting foams.16 A gentle, fragrance-free, foaming liquid facial test cleanser with HMPs has been shown to be well tolerated in women with sensitive skin.20
This report describes 2 studies of a new mild, HMP-containing, foaming facial cleanser with a fragrance that was free of common allergens and irritating essential oils in patients with sensitive skin. Study 1 was designed to evaluate the tolerance and acceptability of 2 variations of the HMP-containing cleanser—one fragrance free and the other with fragrance—in a small sample of healthy adults with clinically diagnosed fragrance-sensitive skin. Study 2 was a large, 2-center study of the tolerability and effectiveness of the fragranced HMP-containing cleanser compared with a benchmark dermatologist-recommended, gentle, fragrance-free, nonfoaming cleanser in women with clinically diagnosed sensitive skin.
Methods
Study 1 Design
The primary objective of this prospective, randomized, single-center, crossover study was to evaluate the tolerability of fragranced versus fragrance-free formulations of a mild, HMP-containing liquid facial cleanser in healthy male and female adults with Fitzpatrick skin types I to IV who were clinically diagnosed as having fragrance sensitivity. Fragrance sensitivity was defined as a history of positive reactions to a fragrance mixture of 8 components (fragrance mixture I) and/or a fragrance mixture of 14 fragrances (fragrance mixture II) that included balsam of Peru (Myroxylonpereirae), geraniol, jasmine oil, and oakmoss.5 All participants provided written informed consent prior to enrolling in the study, and both the study protocol and informed consent agreement were approved by an institutional review board.
Participants were instructed to wash their face twice daily, noting the time of cleansing and providing commentary about their cleansing experience in a diary. The liquid facial test cleansers contained the HMP potassium acrylates copolymer, glycerin, and a surfactant system primarily containing cocamidopropyl betaine and lauryl glucoside prepared without added fragrance (as previously described20) or with a fragrance free of common allergens and irritating essential oils.
Half of the participants used the fragranced test cleanser and half used the fragrance-free test cleanser for a 3-week treatment period (weeks 1–3). Each treatment group subsequently switched to the other test cleanser for a second 3-week treatment period (weeks 4–6). Clinicians assessed global disease severity (an overall assessment of skin condition that was independent of other evaluation criteria), itching/burning, visible irritation, erythema, and desquamation at weekly time points throughout the study and graded each clinical tolerance attribute on a 5-point scale (0=none; 1=minimal; 2=mild; 3=moderate; 4=severe). Ordinal scores at baseline and at weeks 1 and 3 were used to calculate change from baseline.
A 7-item questionnaire also was administered to participants at each visit to assess skin condition, smoothness, softness, cleanliness, radiance, satisfaction with cleansing experience, and lathering. Each item was scored on a 5-point ordinal scale (0=none; 1=minimal; 2=good; 3=excellent; 4=superior). The scores for all parameters were statistically compared with baseline values using a paired t test with a significance level of P≤.05.
Study 2 Design
This prospective, 3-week, double-blind, randomized, comparative, 2-center study to evaluate the tolerability of the fragranced, HMP-containing test cleanser from study 1 versus a benchmark gentle, fragrance-free, nonfoaming cleanser in a large population of otherwise healthy females who had been clinically diagnosed with sensitive skin (not limited to fragrance sensitivity). The study sponsor provided blinded test materials, and neither the examiner nor the recorder knew which investigational product was administered to which participants. Additionally, personnel who dispensed the test cleansers to participants or supervised their use did not participate in the evaluation to minimize potential bias. All participants provided written informed consent prior to enrolling in the study, and the study protocol and informed consent agreement were approved by an institutional review board.
Participants included women aged 18 to 65 years with mild to moderate clinical symptoms of atopic dermatitis, eczema, acne, or rosacea within the 90 days prior to the study period. They were randomized into 2 balanced treatment groups: group 1 received the mild, fragranced, HMP-containing liquid facial cleanser from study 1 and group 2 received a leading, dermatologist-recommended, gentle, fragrance-free, nonfoaming cleanser. Each treatment group used the test cleansers at least once daily for 3 weeks.
Clinicians evaluated facial skin for softness and smoothness, global disease severity (rated visually by the investigator as an overall assessment of skin condition that was independent of other evaluation criteria [as previously described20]), itching, irritation, erythema, and desquamation at baseline and at weeks 1 and 3. The effectiveness of each product to remove facial dirt, cosmetics, and sebum also was assessed; clinical grading was performed as described for study 1 using the same grading scale as in study 1 and percentage change from baseline (improvement) was calculated.
The study also included a self-assessment of skin irritation in which participants responded yes or no to the following question: Have you experienced irritation using this product? Participants also completed a questionnaire in which they were asked to select the most appropriate answer—agree strongly, agree somewhat, neither, disagree somewhat, and disagree strongly— to the following statements: the cleanser leaves no residue; cleanses deep to remove dirt, oil, and makeup; the cleanser effectively removes makeup; the cleanser leaves my skin smooth; the cleanser leaves my skin soft; the cleanser rinses completely clean; cleanser does not over dry my skin; and my skin is completely clean.
The statistical analysis was performed using a nonparametric, 2-tailed, paired Mann-Whitney U test, and statistical significance was set at P≤.05.
Results
Study 1 Assessment
Eight female participants aged 22 to 60 years with clinically diagnosed fragrance sensitivity were enrolled in the study. After 3 weeks of use, clinician assessment showed that both the fragranced and fragrance-free test cleansers with HMPs improved several skin tolerance attributes, including global disease severity, irritation, and erythema (Figure 1). No notable differences in skin tolerance attributes were reported in the fragranced versus the fragrance-free formulations.
There were no reported differences in participant-reported cleanser effectiveness for the fragranced versus the fragrance-free cleanser either at baseline or weeks 1 or 3 (data not shown).
Study 2 Assessment
A total of 153 women aged 25 to 54 years with sensitive skin were enrolled in the study. Seventy-three participants were randomized to receive the fragranced test cleanser and 80 were randomized to receive the benchmark fragrance-free cleanser.
At week 3, there were no differences between the fragranced test cleanser and the benchmark cleanser in any of the clinician-assessed skin parameters (Figure 2). Of the parameters assessed, itching, irritation, and desquamation were the most improved from baseline in both treatment groups. Similar results were observed at week 1 (data not shown).
There were no apparent differences in subjective self-assessment of skin irritation between the test and benchmark cleansers at week 1 (15.7% vs 13.0%) or week 3 (24.3% vs 12.3%). When asked to respond to a series of 8 statements related to cleanser effectiveness, most participants either agreed strongly or agreed somewhat with the statements (Figure 3). There were no statistically significant differences between treatment groups, and responses to all statements indicated that participants were as satisfied with the test cleanser as they were with the benchmark cleanser.
Comment
Consumers value cleansing, fragrance, viscosity, and foaming attributes in skin care products very highly.3,4,10 Fragrances are added to personal care products to positively affect consumers’ perception of product performance and to add emotional benefits by implying social or economic prestige to the use of a product.19 In one study, shampoo formulations that varied only in the added fragrance received different consumer evaluations for cleansing effectiveness and foaming.4
Although mild nonfoaming cleansers can be effective, adult consumers generally use cleansers that foam10,16 and often judge the performance of a cleansing product based on its foaming properties.3,10 Mild cleansers with HMPs maintain the ability to foam while also reducing the likelihood of skin irritation.16 One study showed that a mild, fragrance-free, foaming cleanser containing HMPs was as effective, well tolerated, and nonirritating in patients with sensitive skin as a benchmark nonfoaming gentle cleanser.20
Results from study 1 presented here show that fragranced and fragrance-free formulations of a mild, HMP-containing cleanser are equally efficacious and well tolerated in a small sample of participants with clinically diagnosed fragrance sensitivity. Skin tolerance attributes improved with both cleansers over a 3-week period, particularly global disease severity, irritation, and erythema. These results suggest that a fragrance free of common allergens and irritating essential oils could be introduced into a mild foaming cleanser containing HMPs without causing adverse reactions, even in patients who are fragrance sensitive.
Although the populations of studies 1 and 2 both included female participants with sensitive skin, they were not identical. While study 1 assessed a limited number of participants with clinically diagnosed fragrance sensitivity, study 2 was larger and included a broader range of participants with clinically diagnosed skin sensitivity, which could include fragrance sensitivity. The well-chosen fragrance of the test cleanser containing HMPs was well tolerated; however, this does not imply that any other fragrances added to this cleanser formulation would be as well tolerated.
Conclusion
The current studies indicate that a gentle fragranced foaming cleanser with HMPs was well tolerated in a small population of participants with clinically diagnosed fragrance sensitivity. In a larger population of female participants with sensitive skin, the gentle fragranced foaming cleanser with HMPs was as effective as a leading dermatologist-recommended, fragrance-free, gentle, nonfoaming cleanser. The gentle, HMP-containing, foaming cleanser with a fragrance that does not contain common allergens and irritating essential oils offers a new cleansing option for adults with sensitive skin who may prefer to use a fragranced and foaming product.
Acknowledgments—The authors are grateful to the patients and clinicians who participated in these studies. Editorial and medical writing support was provided by Tove Anderson, PhD, and Alex Loeb, PhD, both from Evidence Scientific Solutions, Inc, Philadelphia, Pennsylvania, and was funded by Johnson & Johnson Consumer Inc.
- Draelos ZD. To smell or not to smell? that is the question! J Cosmet Dermatol. 2013;12:1-2.
- Milotic D. The impact of fragrance on consumer choice. J Consumer Behaviour. 2003;3:179-191.
- Klein K. Evaluating shampoo foam. Cosmetics & Toiletries. 2004;119:32-36.
- Herman S. Skin care: the importance of feel. GCI Magazine. December 2007:70-74.
- Larsen WG. How to test for fragrance allergy. Cutis. 2000;65:39-41.
- Schnuch A, Uter W, Geier J, et al. Epidemiology of contact allergy: an estimation of morbidity employing the clinical epidemiology and drug-utilization research (CE-DUR) approach. Contact Dermatitis. 2002;47:32-39.
- Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. Official Journal of the European Communities. 2003;L66:26-35.
- Guidance note: labelling of ingredients in Cosmetics Directive 76/768/EEC. European Commission Web site. http: //ec.europa.eu/consumers/sectors/cosmetics/files/doc/guide _labelling200802_en.pdf. Updated February 2008. Accessed September 2, 2015.
- Draelos ZD. Sensitive skin: perceptions, evaluation, and treatment. Am J Contact Dermatitis. 1997;8:67-78.
- Abbas S, Goldberg JW, Massaro M. Personal cleanser technology and clinical performance. Dermatol Ther. 2004;17(suppl 1):35-42.
- Ananthapadmanabhan KP, Moore DJ, Subramanyan K, et al. Cleansing without compromise: the impact of cleansers on the skin barrier and the technology of mild cleansing. Dermatol Ther. 2004;17(suppl 1):16-25.
- Walters RM, Mao G, Gunn ET, et al. Cleansing formulations that respect skin barrier integrity. Dermatol Res Pract. 2012;2012:495917.
- Saad P, Flach CR, Walters RM, et al. Infrared spectroscopic studies of sodium dodecyl sulphate permeation and interaction with stratum corneum lipids in skin. Int J Cosmet Sci. 2012;34:36-43.
- Bikowski J. The use of cleansers as therapeutic concomitants in various dermatologic disorders. Cutis. 2001;68(suppl 5):12-19.
- Walters RM, Fevola MJ, LiBrizzi JJ, et al. Designing cleansers for the unique needs of baby skin. Cosmetics & Toiletries. 2008;123:53-60.
- Fevola MJ, Walters RM, LiBrizzi JJ. A new approach to formulating mild cleansers: hydrophobically-modified polymers for irritation mitigation. In: Morgan SE, Lochhead RY, eds. Polymeric Delivery of Therapeutics. Vol 1053. Washington, DC: American Chemical Society; 2011:221-242.
- Nelson SA, Yiannias JA. Relevance and avoidance of skin-care product allergens: pearls and pitfalls. Dermatol Clin. 2009;27:329-336.
- Arribas MP, Soro P, Silvestre JF. Allergic contact dermatitis to fragrances: part 2. Actas Dermosifiliogr. 2013;104:29-37.
- Schroeder W. Understanding fragrance in personal care. Cosmetics & Toiletries. 2009;124:36-44.
- Draelos Z, Hornby S, Walters RM, et al. Hydrophobically-modified polymers can minimize skin irritation potential caused by surfactant-based cleansers. J Cosmet Dermatol. 2013;12:314-321.
For thousands of years, humans have used fragrances to change or affect their mood and enhance an “aura of beauty.”1 Fragrance is a primary driver in consumer choice and purchasing decisions, especially when considering personal care products.2 In addition to fragrance, consumers choose cleanser products based on compatibility with skin, cleansing properties, and sensory attributes such as viscosity and foaming.3,4 However, fragrance sensitivity is among the most common causes of allergic contact dermatitis from cosmetics and personal care products,5 and estimates of the prevalence of fragrance sensitivity range from 1.8% to 4.2%.6
A panel of 26 fragrance ingredients that frequently induce contact dermatitis in sensitive individuals has been identified.7 Since 2003, regulatory authorities in the European Union require these compounds to be listed on the labels of consumer products to protect presensitized consumers.7,8 However, manufacturers of cosmetics are not required to specify allergenic fragrance ingredients outside the European Union, and therefore it is difficult for consumers in the United States to avoid fragrance allergens.
Creation of a fragranced product for fragrance-sensitive individuals begins with careful selection of ingredients and extensive formulation testing and evaluation. This process usually is followed by testing in normal individuals to confirm that the fragranced product is well accepted and then evaluation is done in clinically confirmed fragrance-sensitive patients and those with a compromised skin barrier from atopic dermatitis, rosacea, or eczema.
Sensitive skin may be due to increased immune responsiveness, altered neurosensory input, and/or decreased skin barrier function, and presents a complex challenge for dermatologists.9 Subjective perceptions of sensitive skin include stinging, burning, pruritus, and tightness following product application. Clinically sensitive skin is defined by the presence of erythema, stratum corneum desquamation, papules, pustules, wheals, vesicles, bullae, and/or erosions.9 Although some of these symptoms may be observed immediately, others may be delayed by minutes, hours, or days following the use of an irritating product. Patients who present with subjective symptoms of sensitive skin may or may not show objective symptoms.
Gentle skin cleansing is particularly important for patients with compromised skin barrier integrity, such as those with acne, atopic dermatitis, eczema, or rosacea. Standard alkaline surfactants in skin cleansers help to remove dirt and oily soil and produce lather but can impair the skin barrier function and facilitate development of irritation.10-13 The tolerability of a cleanser is influenced by its pH, the type and amount of surfactant ingredients, the presence of moisturizing agents, and the amount of residue left on the skin after washing.11,12 Mild cleansers have been developed for patients with sensitive skin conditions and are expected to provide cleansing benefits without negatively affecting the hydration and viscoelastic properties of skin.11 Mild cleansers interact minimally with skin proteins and lipids because they usually contain nonionic synthetic surfactant mixtures; they also have a pH value close to the slightly acidic pH of normal skin, contain moisturizing agents,11,14,15 and usually produce less foam.10,16 In patients with sensitive skin, mild and fragrance-free cleansers often are recommended.17,18 Because fragrances often affect consumers’ perception of product performance19 and enhance the cleaning experience of the user, consumer compliance with clinical recommendations to use fragrance-free cleansers often is poor.
Low–molecular-weight, water-soluble, hydrophobically modified polymers (HMPs) have been used to create gentle foaming cleansers with reduced impact on the skin barrier.12,16,20 In the presence of HMPs, surfactants assemble into larger, more stable polymer-surfactant structures that are less likely to penetrate the skin.16 Hydrophobically modified polymers can potentially reduce skin irritation by lowering the concentration of free micelles in solution. Additionally, both HMPs and HMP-surfactant complexes stabilize newly formed air-water interfaces, leading to thicker, denser, and longer-lasting foams.16 A gentle, fragrance-free, foaming liquid facial test cleanser with HMPs has been shown to be well tolerated in women with sensitive skin.20
This report describes 2 studies of a new mild, HMP-containing, foaming facial cleanser with a fragrance that was free of common allergens and irritating essential oils in patients with sensitive skin. Study 1 was designed to evaluate the tolerance and acceptability of 2 variations of the HMP-containing cleanser—one fragrance free and the other with fragrance—in a small sample of healthy adults with clinically diagnosed fragrance-sensitive skin. Study 2 was a large, 2-center study of the tolerability and effectiveness of the fragranced HMP-containing cleanser compared with a benchmark dermatologist-recommended, gentle, fragrance-free, nonfoaming cleanser in women with clinically diagnosed sensitive skin.
Methods
Study 1 Design
The primary objective of this prospective, randomized, single-center, crossover study was to evaluate the tolerability of fragranced versus fragrance-free formulations of a mild, HMP-containing liquid facial cleanser in healthy male and female adults with Fitzpatrick skin types I to IV who were clinically diagnosed as having fragrance sensitivity. Fragrance sensitivity was defined as a history of positive reactions to a fragrance mixture of 8 components (fragrance mixture I) and/or a fragrance mixture of 14 fragrances (fragrance mixture II) that included balsam of Peru (Myroxylonpereirae), geraniol, jasmine oil, and oakmoss.5 All participants provided written informed consent prior to enrolling in the study, and both the study protocol and informed consent agreement were approved by an institutional review board.
Participants were instructed to wash their face twice daily, noting the time of cleansing and providing commentary about their cleansing experience in a diary. The liquid facial test cleansers contained the HMP potassium acrylates copolymer, glycerin, and a surfactant system primarily containing cocamidopropyl betaine and lauryl glucoside prepared without added fragrance (as previously described20) or with a fragrance free of common allergens and irritating essential oils.
Half of the participants used the fragranced test cleanser and half used the fragrance-free test cleanser for a 3-week treatment period (weeks 1–3). Each treatment group subsequently switched to the other test cleanser for a second 3-week treatment period (weeks 4–6). Clinicians assessed global disease severity (an overall assessment of skin condition that was independent of other evaluation criteria), itching/burning, visible irritation, erythema, and desquamation at weekly time points throughout the study and graded each clinical tolerance attribute on a 5-point scale (0=none; 1=minimal; 2=mild; 3=moderate; 4=severe). Ordinal scores at baseline and at weeks 1 and 3 were used to calculate change from baseline.
A 7-item questionnaire also was administered to participants at each visit to assess skin condition, smoothness, softness, cleanliness, radiance, satisfaction with cleansing experience, and lathering. Each item was scored on a 5-point ordinal scale (0=none; 1=minimal; 2=good; 3=excellent; 4=superior). The scores for all parameters were statistically compared with baseline values using a paired t test with a significance level of P≤.05.
Study 2 Design
This prospective, 3-week, double-blind, randomized, comparative, 2-center study to evaluate the tolerability of the fragranced, HMP-containing test cleanser from study 1 versus a benchmark gentle, fragrance-free, nonfoaming cleanser in a large population of otherwise healthy females who had been clinically diagnosed with sensitive skin (not limited to fragrance sensitivity). The study sponsor provided blinded test materials, and neither the examiner nor the recorder knew which investigational product was administered to which participants. Additionally, personnel who dispensed the test cleansers to participants or supervised their use did not participate in the evaluation to minimize potential bias. All participants provided written informed consent prior to enrolling in the study, and the study protocol and informed consent agreement were approved by an institutional review board.
Participants included women aged 18 to 65 years with mild to moderate clinical symptoms of atopic dermatitis, eczema, acne, or rosacea within the 90 days prior to the study period. They were randomized into 2 balanced treatment groups: group 1 received the mild, fragranced, HMP-containing liquid facial cleanser from study 1 and group 2 received a leading, dermatologist-recommended, gentle, fragrance-free, nonfoaming cleanser. Each treatment group used the test cleansers at least once daily for 3 weeks.
Clinicians evaluated facial skin for softness and smoothness, global disease severity (rated visually by the investigator as an overall assessment of skin condition that was independent of other evaluation criteria [as previously described20]), itching, irritation, erythema, and desquamation at baseline and at weeks 1 and 3. The effectiveness of each product to remove facial dirt, cosmetics, and sebum also was assessed; clinical grading was performed as described for study 1 using the same grading scale as in study 1 and percentage change from baseline (improvement) was calculated.
The study also included a self-assessment of skin irritation in which participants responded yes or no to the following question: Have you experienced irritation using this product? Participants also completed a questionnaire in which they were asked to select the most appropriate answer—agree strongly, agree somewhat, neither, disagree somewhat, and disagree strongly— to the following statements: the cleanser leaves no residue; cleanses deep to remove dirt, oil, and makeup; the cleanser effectively removes makeup; the cleanser leaves my skin smooth; the cleanser leaves my skin soft; the cleanser rinses completely clean; cleanser does not over dry my skin; and my skin is completely clean.
The statistical analysis was performed using a nonparametric, 2-tailed, paired Mann-Whitney U test, and statistical significance was set at P≤.05.
Results
Study 1 Assessment
Eight female participants aged 22 to 60 years with clinically diagnosed fragrance sensitivity were enrolled in the study. After 3 weeks of use, clinician assessment showed that both the fragranced and fragrance-free test cleansers with HMPs improved several skin tolerance attributes, including global disease severity, irritation, and erythema (Figure 1). No notable differences in skin tolerance attributes were reported in the fragranced versus the fragrance-free formulations.
There were no reported differences in participant-reported cleanser effectiveness for the fragranced versus the fragrance-free cleanser either at baseline or weeks 1 or 3 (data not shown).
Study 2 Assessment
A total of 153 women aged 25 to 54 years with sensitive skin were enrolled in the study. Seventy-three participants were randomized to receive the fragranced test cleanser and 80 were randomized to receive the benchmark fragrance-free cleanser.
At week 3, there were no differences between the fragranced test cleanser and the benchmark cleanser in any of the clinician-assessed skin parameters (Figure 2). Of the parameters assessed, itching, irritation, and desquamation were the most improved from baseline in both treatment groups. Similar results were observed at week 1 (data not shown).
There were no apparent differences in subjective self-assessment of skin irritation between the test and benchmark cleansers at week 1 (15.7% vs 13.0%) or week 3 (24.3% vs 12.3%). When asked to respond to a series of 8 statements related to cleanser effectiveness, most participants either agreed strongly or agreed somewhat with the statements (Figure 3). There were no statistically significant differences between treatment groups, and responses to all statements indicated that participants were as satisfied with the test cleanser as they were with the benchmark cleanser.
Comment
Consumers value cleansing, fragrance, viscosity, and foaming attributes in skin care products very highly.3,4,10 Fragrances are added to personal care products to positively affect consumers’ perception of product performance and to add emotional benefits by implying social or economic prestige to the use of a product.19 In one study, shampoo formulations that varied only in the added fragrance received different consumer evaluations for cleansing effectiveness and foaming.4
Although mild nonfoaming cleansers can be effective, adult consumers generally use cleansers that foam10,16 and often judge the performance of a cleansing product based on its foaming properties.3,10 Mild cleansers with HMPs maintain the ability to foam while also reducing the likelihood of skin irritation.16 One study showed that a mild, fragrance-free, foaming cleanser containing HMPs was as effective, well tolerated, and nonirritating in patients with sensitive skin as a benchmark nonfoaming gentle cleanser.20
Results from study 1 presented here show that fragranced and fragrance-free formulations of a mild, HMP-containing cleanser are equally efficacious and well tolerated in a small sample of participants with clinically diagnosed fragrance sensitivity. Skin tolerance attributes improved with both cleansers over a 3-week period, particularly global disease severity, irritation, and erythema. These results suggest that a fragrance free of common allergens and irritating essential oils could be introduced into a mild foaming cleanser containing HMPs without causing adverse reactions, even in patients who are fragrance sensitive.
Although the populations of studies 1 and 2 both included female participants with sensitive skin, they were not identical. While study 1 assessed a limited number of participants with clinically diagnosed fragrance sensitivity, study 2 was larger and included a broader range of participants with clinically diagnosed skin sensitivity, which could include fragrance sensitivity. The well-chosen fragrance of the test cleanser containing HMPs was well tolerated; however, this does not imply that any other fragrances added to this cleanser formulation would be as well tolerated.
Conclusion
The current studies indicate that a gentle fragranced foaming cleanser with HMPs was well tolerated in a small population of participants with clinically diagnosed fragrance sensitivity. In a larger population of female participants with sensitive skin, the gentle fragranced foaming cleanser with HMPs was as effective as a leading dermatologist-recommended, fragrance-free, gentle, nonfoaming cleanser. The gentle, HMP-containing, foaming cleanser with a fragrance that does not contain common allergens and irritating essential oils offers a new cleansing option for adults with sensitive skin who may prefer to use a fragranced and foaming product.
Acknowledgments—The authors are grateful to the patients and clinicians who participated in these studies. Editorial and medical writing support was provided by Tove Anderson, PhD, and Alex Loeb, PhD, both from Evidence Scientific Solutions, Inc, Philadelphia, Pennsylvania, and was funded by Johnson & Johnson Consumer Inc.
For thousands of years, humans have used fragrances to change or affect their mood and enhance an “aura of beauty.”1 Fragrance is a primary driver in consumer choice and purchasing decisions, especially when considering personal care products.2 In addition to fragrance, consumers choose cleanser products based on compatibility with skin, cleansing properties, and sensory attributes such as viscosity and foaming.3,4 However, fragrance sensitivity is among the most common causes of allergic contact dermatitis from cosmetics and personal care products,5 and estimates of the prevalence of fragrance sensitivity range from 1.8% to 4.2%.6
A panel of 26 fragrance ingredients that frequently induce contact dermatitis in sensitive individuals has been identified.7 Since 2003, regulatory authorities in the European Union require these compounds to be listed on the labels of consumer products to protect presensitized consumers.7,8 However, manufacturers of cosmetics are not required to specify allergenic fragrance ingredients outside the European Union, and therefore it is difficult for consumers in the United States to avoid fragrance allergens.
Creation of a fragranced product for fragrance-sensitive individuals begins with careful selection of ingredients and extensive formulation testing and evaluation. This process usually is followed by testing in normal individuals to confirm that the fragranced product is well accepted and then evaluation is done in clinically confirmed fragrance-sensitive patients and those with a compromised skin barrier from atopic dermatitis, rosacea, or eczema.
Sensitive skin may be due to increased immune responsiveness, altered neurosensory input, and/or decreased skin barrier function, and presents a complex challenge for dermatologists.9 Subjective perceptions of sensitive skin include stinging, burning, pruritus, and tightness following product application. Clinically sensitive skin is defined by the presence of erythema, stratum corneum desquamation, papules, pustules, wheals, vesicles, bullae, and/or erosions.9 Although some of these symptoms may be observed immediately, others may be delayed by minutes, hours, or days following the use of an irritating product. Patients who present with subjective symptoms of sensitive skin may or may not show objective symptoms.
Gentle skin cleansing is particularly important for patients with compromised skin barrier integrity, such as those with acne, atopic dermatitis, eczema, or rosacea. Standard alkaline surfactants in skin cleansers help to remove dirt and oily soil and produce lather but can impair the skin barrier function and facilitate development of irritation.10-13 The tolerability of a cleanser is influenced by its pH, the type and amount of surfactant ingredients, the presence of moisturizing agents, and the amount of residue left on the skin after washing.11,12 Mild cleansers have been developed for patients with sensitive skin conditions and are expected to provide cleansing benefits without negatively affecting the hydration and viscoelastic properties of skin.11 Mild cleansers interact minimally with skin proteins and lipids because they usually contain nonionic synthetic surfactant mixtures; they also have a pH value close to the slightly acidic pH of normal skin, contain moisturizing agents,11,14,15 and usually produce less foam.10,16 In patients with sensitive skin, mild and fragrance-free cleansers often are recommended.17,18 Because fragrances often affect consumers’ perception of product performance19 and enhance the cleaning experience of the user, consumer compliance with clinical recommendations to use fragrance-free cleansers often is poor.
Low–molecular-weight, water-soluble, hydrophobically modified polymers (HMPs) have been used to create gentle foaming cleansers with reduced impact on the skin barrier.12,16,20 In the presence of HMPs, surfactants assemble into larger, more stable polymer-surfactant structures that are less likely to penetrate the skin.16 Hydrophobically modified polymers can potentially reduce skin irritation by lowering the concentration of free micelles in solution. Additionally, both HMPs and HMP-surfactant complexes stabilize newly formed air-water interfaces, leading to thicker, denser, and longer-lasting foams.16 A gentle, fragrance-free, foaming liquid facial test cleanser with HMPs has been shown to be well tolerated in women with sensitive skin.20
This report describes 2 studies of a new mild, HMP-containing, foaming facial cleanser with a fragrance that was free of common allergens and irritating essential oils in patients with sensitive skin. Study 1 was designed to evaluate the tolerance and acceptability of 2 variations of the HMP-containing cleanser—one fragrance free and the other with fragrance—in a small sample of healthy adults with clinically diagnosed fragrance-sensitive skin. Study 2 was a large, 2-center study of the tolerability and effectiveness of the fragranced HMP-containing cleanser compared with a benchmark dermatologist-recommended, gentle, fragrance-free, nonfoaming cleanser in women with clinically diagnosed sensitive skin.
Methods
Study 1 Design
The primary objective of this prospective, randomized, single-center, crossover study was to evaluate the tolerability of fragranced versus fragrance-free formulations of a mild, HMP-containing liquid facial cleanser in healthy male and female adults with Fitzpatrick skin types I to IV who were clinically diagnosed as having fragrance sensitivity. Fragrance sensitivity was defined as a history of positive reactions to a fragrance mixture of 8 components (fragrance mixture I) and/or a fragrance mixture of 14 fragrances (fragrance mixture II) that included balsam of Peru (Myroxylonpereirae), geraniol, jasmine oil, and oakmoss.5 All participants provided written informed consent prior to enrolling in the study, and both the study protocol and informed consent agreement were approved by an institutional review board.
Participants were instructed to wash their face twice daily, noting the time of cleansing and providing commentary about their cleansing experience in a diary. The liquid facial test cleansers contained the HMP potassium acrylates copolymer, glycerin, and a surfactant system primarily containing cocamidopropyl betaine and lauryl glucoside prepared without added fragrance (as previously described20) or with a fragrance free of common allergens and irritating essential oils.
Half of the participants used the fragranced test cleanser and half used the fragrance-free test cleanser for a 3-week treatment period (weeks 1–3). Each treatment group subsequently switched to the other test cleanser for a second 3-week treatment period (weeks 4–6). Clinicians assessed global disease severity (an overall assessment of skin condition that was independent of other evaluation criteria), itching/burning, visible irritation, erythema, and desquamation at weekly time points throughout the study and graded each clinical tolerance attribute on a 5-point scale (0=none; 1=minimal; 2=mild; 3=moderate; 4=severe). Ordinal scores at baseline and at weeks 1 and 3 were used to calculate change from baseline.
A 7-item questionnaire also was administered to participants at each visit to assess skin condition, smoothness, softness, cleanliness, radiance, satisfaction with cleansing experience, and lathering. Each item was scored on a 5-point ordinal scale (0=none; 1=minimal; 2=good; 3=excellent; 4=superior). The scores for all parameters were statistically compared with baseline values using a paired t test with a significance level of P≤.05.
Study 2 Design
This prospective, 3-week, double-blind, randomized, comparative, 2-center study to evaluate the tolerability of the fragranced, HMP-containing test cleanser from study 1 versus a benchmark gentle, fragrance-free, nonfoaming cleanser in a large population of otherwise healthy females who had been clinically diagnosed with sensitive skin (not limited to fragrance sensitivity). The study sponsor provided blinded test materials, and neither the examiner nor the recorder knew which investigational product was administered to which participants. Additionally, personnel who dispensed the test cleansers to participants or supervised their use did not participate in the evaluation to minimize potential bias. All participants provided written informed consent prior to enrolling in the study, and the study protocol and informed consent agreement were approved by an institutional review board.
Participants included women aged 18 to 65 years with mild to moderate clinical symptoms of atopic dermatitis, eczema, acne, or rosacea within the 90 days prior to the study period. They were randomized into 2 balanced treatment groups: group 1 received the mild, fragranced, HMP-containing liquid facial cleanser from study 1 and group 2 received a leading, dermatologist-recommended, gentle, fragrance-free, nonfoaming cleanser. Each treatment group used the test cleansers at least once daily for 3 weeks.
Clinicians evaluated facial skin for softness and smoothness, global disease severity (rated visually by the investigator as an overall assessment of skin condition that was independent of other evaluation criteria [as previously described20]), itching, irritation, erythema, and desquamation at baseline and at weeks 1 and 3. The effectiveness of each product to remove facial dirt, cosmetics, and sebum also was assessed; clinical grading was performed as described for study 1 using the same grading scale as in study 1 and percentage change from baseline (improvement) was calculated.
The study also included a self-assessment of skin irritation in which participants responded yes or no to the following question: Have you experienced irritation using this product? Participants also completed a questionnaire in which they were asked to select the most appropriate answer—agree strongly, agree somewhat, neither, disagree somewhat, and disagree strongly— to the following statements: the cleanser leaves no residue; cleanses deep to remove dirt, oil, and makeup; the cleanser effectively removes makeup; the cleanser leaves my skin smooth; the cleanser leaves my skin soft; the cleanser rinses completely clean; cleanser does not over dry my skin; and my skin is completely clean.
The statistical analysis was performed using a nonparametric, 2-tailed, paired Mann-Whitney U test, and statistical significance was set at P≤.05.
Results
Study 1 Assessment
Eight female participants aged 22 to 60 years with clinically diagnosed fragrance sensitivity were enrolled in the study. After 3 weeks of use, clinician assessment showed that both the fragranced and fragrance-free test cleansers with HMPs improved several skin tolerance attributes, including global disease severity, irritation, and erythema (Figure 1). No notable differences in skin tolerance attributes were reported in the fragranced versus the fragrance-free formulations.
There were no reported differences in participant-reported cleanser effectiveness for the fragranced versus the fragrance-free cleanser either at baseline or weeks 1 or 3 (data not shown).
Study 2 Assessment
A total of 153 women aged 25 to 54 years with sensitive skin were enrolled in the study. Seventy-three participants were randomized to receive the fragranced test cleanser and 80 were randomized to receive the benchmark fragrance-free cleanser.
At week 3, there were no differences between the fragranced test cleanser and the benchmark cleanser in any of the clinician-assessed skin parameters (Figure 2). Of the parameters assessed, itching, irritation, and desquamation were the most improved from baseline in both treatment groups. Similar results were observed at week 1 (data not shown).
There were no apparent differences in subjective self-assessment of skin irritation between the test and benchmark cleansers at week 1 (15.7% vs 13.0%) or week 3 (24.3% vs 12.3%). When asked to respond to a series of 8 statements related to cleanser effectiveness, most participants either agreed strongly or agreed somewhat with the statements (Figure 3). There were no statistically significant differences between treatment groups, and responses to all statements indicated that participants were as satisfied with the test cleanser as they were with the benchmark cleanser.
Comment
Consumers value cleansing, fragrance, viscosity, and foaming attributes in skin care products very highly.3,4,10 Fragrances are added to personal care products to positively affect consumers’ perception of product performance and to add emotional benefits by implying social or economic prestige to the use of a product.19 In one study, shampoo formulations that varied only in the added fragrance received different consumer evaluations for cleansing effectiveness and foaming.4
Although mild nonfoaming cleansers can be effective, adult consumers generally use cleansers that foam10,16 and often judge the performance of a cleansing product based on its foaming properties.3,10 Mild cleansers with HMPs maintain the ability to foam while also reducing the likelihood of skin irritation.16 One study showed that a mild, fragrance-free, foaming cleanser containing HMPs was as effective, well tolerated, and nonirritating in patients with sensitive skin as a benchmark nonfoaming gentle cleanser.20
Results from study 1 presented here show that fragranced and fragrance-free formulations of a mild, HMP-containing cleanser are equally efficacious and well tolerated in a small sample of participants with clinically diagnosed fragrance sensitivity. Skin tolerance attributes improved with both cleansers over a 3-week period, particularly global disease severity, irritation, and erythema. These results suggest that a fragrance free of common allergens and irritating essential oils could be introduced into a mild foaming cleanser containing HMPs without causing adverse reactions, even in patients who are fragrance sensitive.
Although the populations of studies 1 and 2 both included female participants with sensitive skin, they were not identical. While study 1 assessed a limited number of participants with clinically diagnosed fragrance sensitivity, study 2 was larger and included a broader range of participants with clinically diagnosed skin sensitivity, which could include fragrance sensitivity. The well-chosen fragrance of the test cleanser containing HMPs was well tolerated; however, this does not imply that any other fragrances added to this cleanser formulation would be as well tolerated.
Conclusion
The current studies indicate that a gentle fragranced foaming cleanser with HMPs was well tolerated in a small population of participants with clinically diagnosed fragrance sensitivity. In a larger population of female participants with sensitive skin, the gentle fragranced foaming cleanser with HMPs was as effective as a leading dermatologist-recommended, fragrance-free, gentle, nonfoaming cleanser. The gentle, HMP-containing, foaming cleanser with a fragrance that does not contain common allergens and irritating essential oils offers a new cleansing option for adults with sensitive skin who may prefer to use a fragranced and foaming product.
Acknowledgments—The authors are grateful to the patients and clinicians who participated in these studies. Editorial and medical writing support was provided by Tove Anderson, PhD, and Alex Loeb, PhD, both from Evidence Scientific Solutions, Inc, Philadelphia, Pennsylvania, and was funded by Johnson & Johnson Consumer Inc.
- Draelos ZD. To smell or not to smell? that is the question! J Cosmet Dermatol. 2013;12:1-2.
- Milotic D. The impact of fragrance on consumer choice. J Consumer Behaviour. 2003;3:179-191.
- Klein K. Evaluating shampoo foam. Cosmetics & Toiletries. 2004;119:32-36.
- Herman S. Skin care: the importance of feel. GCI Magazine. December 2007:70-74.
- Larsen WG. How to test for fragrance allergy. Cutis. 2000;65:39-41.
- Schnuch A, Uter W, Geier J, et al. Epidemiology of contact allergy: an estimation of morbidity employing the clinical epidemiology and drug-utilization research (CE-DUR) approach. Contact Dermatitis. 2002;47:32-39.
- Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. Official Journal of the European Communities. 2003;L66:26-35.
- Guidance note: labelling of ingredients in Cosmetics Directive 76/768/EEC. European Commission Web site. http: //ec.europa.eu/consumers/sectors/cosmetics/files/doc/guide _labelling200802_en.pdf. Updated February 2008. Accessed September 2, 2015.
- Draelos ZD. Sensitive skin: perceptions, evaluation, and treatment. Am J Contact Dermatitis. 1997;8:67-78.
- Abbas S, Goldberg JW, Massaro M. Personal cleanser technology and clinical performance. Dermatol Ther. 2004;17(suppl 1):35-42.
- Ananthapadmanabhan KP, Moore DJ, Subramanyan K, et al. Cleansing without compromise: the impact of cleansers on the skin barrier and the technology of mild cleansing. Dermatol Ther. 2004;17(suppl 1):16-25.
- Walters RM, Mao G, Gunn ET, et al. Cleansing formulations that respect skin barrier integrity. Dermatol Res Pract. 2012;2012:495917.
- Saad P, Flach CR, Walters RM, et al. Infrared spectroscopic studies of sodium dodecyl sulphate permeation and interaction with stratum corneum lipids in skin. Int J Cosmet Sci. 2012;34:36-43.
- Bikowski J. The use of cleansers as therapeutic concomitants in various dermatologic disorders. Cutis. 2001;68(suppl 5):12-19.
- Walters RM, Fevola MJ, LiBrizzi JJ, et al. Designing cleansers for the unique needs of baby skin. Cosmetics & Toiletries. 2008;123:53-60.
- Fevola MJ, Walters RM, LiBrizzi JJ. A new approach to formulating mild cleansers: hydrophobically-modified polymers for irritation mitigation. In: Morgan SE, Lochhead RY, eds. Polymeric Delivery of Therapeutics. Vol 1053. Washington, DC: American Chemical Society; 2011:221-242.
- Nelson SA, Yiannias JA. Relevance and avoidance of skin-care product allergens: pearls and pitfalls. Dermatol Clin. 2009;27:329-336.
- Arribas MP, Soro P, Silvestre JF. Allergic contact dermatitis to fragrances: part 2. Actas Dermosifiliogr. 2013;104:29-37.
- Schroeder W. Understanding fragrance in personal care. Cosmetics & Toiletries. 2009;124:36-44.
- Draelos Z, Hornby S, Walters RM, et al. Hydrophobically-modified polymers can minimize skin irritation potential caused by surfactant-based cleansers. J Cosmet Dermatol. 2013;12:314-321.
- Draelos ZD. To smell or not to smell? that is the question! J Cosmet Dermatol. 2013;12:1-2.
- Milotic D. The impact of fragrance on consumer choice. J Consumer Behaviour. 2003;3:179-191.
- Klein K. Evaluating shampoo foam. Cosmetics & Toiletries. 2004;119:32-36.
- Herman S. Skin care: the importance of feel. GCI Magazine. December 2007:70-74.
- Larsen WG. How to test for fragrance allergy. Cutis. 2000;65:39-41.
- Schnuch A, Uter W, Geier J, et al. Epidemiology of contact allergy: an estimation of morbidity employing the clinical epidemiology and drug-utilization research (CE-DUR) approach. Contact Dermatitis. 2002;47:32-39.
- Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. Official Journal of the European Communities. 2003;L66:26-35.
- Guidance note: labelling of ingredients in Cosmetics Directive 76/768/EEC. European Commission Web site. http: //ec.europa.eu/consumers/sectors/cosmetics/files/doc/guide _labelling200802_en.pdf. Updated February 2008. Accessed September 2, 2015.
- Draelos ZD. Sensitive skin: perceptions, evaluation, and treatment. Am J Contact Dermatitis. 1997;8:67-78.
- Abbas S, Goldberg JW, Massaro M. Personal cleanser technology and clinical performance. Dermatol Ther. 2004;17(suppl 1):35-42.
- Ananthapadmanabhan KP, Moore DJ, Subramanyan K, et al. Cleansing without compromise: the impact of cleansers on the skin barrier and the technology of mild cleansing. Dermatol Ther. 2004;17(suppl 1):16-25.
- Walters RM, Mao G, Gunn ET, et al. Cleansing formulations that respect skin barrier integrity. Dermatol Res Pract. 2012;2012:495917.
- Saad P, Flach CR, Walters RM, et al. Infrared spectroscopic studies of sodium dodecyl sulphate permeation and interaction with stratum corneum lipids in skin. Int J Cosmet Sci. 2012;34:36-43.
- Bikowski J. The use of cleansers as therapeutic concomitants in various dermatologic disorders. Cutis. 2001;68(suppl 5):12-19.
- Walters RM, Fevola MJ, LiBrizzi JJ, et al. Designing cleansers for the unique needs of baby skin. Cosmetics & Toiletries. 2008;123:53-60.
- Fevola MJ, Walters RM, LiBrizzi JJ. A new approach to formulating mild cleansers: hydrophobically-modified polymers for irritation mitigation. In: Morgan SE, Lochhead RY, eds. Polymeric Delivery of Therapeutics. Vol 1053. Washington, DC: American Chemical Society; 2011:221-242.
- Nelson SA, Yiannias JA. Relevance and avoidance of skin-care product allergens: pearls and pitfalls. Dermatol Clin. 2009;27:329-336.
- Arribas MP, Soro P, Silvestre JF. Allergic contact dermatitis to fragrances: part 2. Actas Dermosifiliogr. 2013;104:29-37.
- Schroeder W. Understanding fragrance in personal care. Cosmetics & Toiletries. 2009;124:36-44.
- Draelos Z, Hornby S, Walters RM, et al. Hydrophobically-modified polymers can minimize skin irritation potential caused by surfactant-based cleansers. J Cosmet Dermatol. 2013;12:314-321.
Practice Points
- Fragranced and fragrance-free versions of a gentle foaming cleanser with hydrophobically modified polymers (HMPs) were similarly well tolerated in participants with clinically diagnosed fragrance sensitivity.
- In a large population of female participants with sensitive skin, the fragranced gentle foaming cleanser with HMPs was as effective as a leading dermatologist-recommended, fragrance-free, gentle, nonfoaming cleanser.
- The gentle, HMP-containing, foaming cleanser with a fragrance offers a new cleansing option for adults with sensitive skin who may prefer to use a fragranced and foaming product.
Guideline‐Concordant Antibiotic Use
Clinical guidelines are prevalent in the field of medicine, but physicians do not consistently provide guideline‐concordant care. Nonadherence to guidelines has been documented for a variety of clinical conditions, including chronic obstructive pulmonary disease,[1, 2] pain management,[3, 4] and major depressive disorder.[5, 6]
Although several professional societies, including the Infectious Diseases Society of America (IDSA), have developed and disseminated guidelines on antibiotic use, adherence to antibiotic‐prescribing guidelines is inconsistent. Several studies have documented inappropriate antibiotic prescribing for specific infections, including acute respiratory infections,[7, 8, 9] cellulitis,[10, 11] and asymptomatic bacteriuria.[12, 13]
Improving adherence to guidelines on antibiotic use could have several benefits. For certain infections, guideline adherence has been shown to improve patient outcomes and reduce resource utilization.[10, 14, 15] In general, guidelines promote more judicious use of antibiotics by clarifying when an antibiotic is indicated, which antibiotics to prescribe, and duration of antibiotic therapy. The more judicious use of antibiotics decreases a given patient's risk of developing an antibiotic‐resistant infection and Clostridium difficileassociated diarrhea.[16] Judicious antibiotic use will also have societal benefits by slowing the spread of antibiotic‐resistant bacteria.
As part of a local effort to improve antibiotic use, we decided to present physicians with hypothetical cases of common clinical scenarios to identify barriers to following antibiotic‐prescribing guidelines. Previous investigators have used case vignettes to assess the quality of care physicians provide, including decisions about antibiotics.[17, 18, 19, 20, 21] We used case vignettes to assess physicians' familiarity with and acceptance of IDSA guidelines for 3 common infectious conditions: skin and soft tissue infections (SSTI), suspected hospital‐acquired pneumonia (HAP), and asymptomatic bacteriuria (ASB). The findings from our project were intended to inform local interventions to improve antibiotic prescribing.
METHODS
All interviews were conducted at 2 acute care hospitals in Indianapolis, Indiana: Sidney and Lois Eskenazi Hospital and the Richard Roudebush Veterans Affairs Medical Center (VAMC). Eskenazi Hospital is a 316‐bed safety‐net hospital for Marion County, Indiana. The Roudebush VAMC is a 209‐bed tertiary care facility that provides comprehensive medical care for 85,000 veterans. Both hospitals are academically affiliated with Indiana University's School of Medicine.
Both hospitals have empiric antibiotic‐prescribing guidelines printed in their annual antibiograms. These guidelines, developed by each hospital's pharmacy department and the local infectious disease (ID) physicians, are distributed annually as a pocket booklet. During this study, an antibiotic stewardship program was active at hospital A but not hospital B. As part of this program at hospital A, an ID physician reviewed inpatients on antibiotics twice a week and, with the help of inpatient team pharmacists, provided feedback to the frontline prescribers.
For this study, inpatient physicians who prescribe antibiotics at either facility were invited to participate in a 30‐minute confidential interview about their antibiotic‐prescribing habits. All invitations were sent through electronic mail. The target enrollment was 30 physicians, which is consistent with prior literature on qualitative sampling.[22] Sampling was purposeful to recruit a heterogeneous group of participants from both hospital sites. Although such a sampling strategy precluded us from making conclusions about individual subgroups, our intention was to obtain the broadest range of information and perspectives, thereby challenging our own preconceived understandings and biases.
The protocol and conduct of this study were reviewed and approved by the Indiana University Institutional Review Board. Participants read and provided signed informed consent. No compensation was provided to physician participants.
A research assistant (A.R.C.) trained in qualitative interviewing conducted all interviews.[23] These interviews covered social norms, perceptions of risk, self‐efficacy, knowledge, and acceptance of guidelines. At the end of the interview, each participant was asked to respond to 3 case vignettes (Table 1), which had been developed by an ID physician (D.L.) based on both local and IDSA guidelines.[24, 25, 26] Participants decided whether to prescribe antibiotics and, if so, which antibiotic to use. After their response, the interviewer read aloud specific recommendations from IDSA guidelines and asked, Would you feel comfortable applying this recommendation to your practice? Are there situations when you would not apply this recommendation?
|
| 1. A 40‐year‐old man with poorly controlled type 2 diabetes develops pain and redness over the dorsum of his foot. He presents to the emergency room the day after these symptoms started. He denies any recent penetrating injuries to his foot, including no animal bites, and denies any water exposure. At the time of presentation, his temperature is 101.1F, pulse 89, his blood pressure is 124/76, and his respiratory rate is 16. Tender edema, warmth, and erythema extend up to the pretibial area of his right lower leg. Fissures are present between his toes, but he has no foot ulcers. There are no blisters or purulence. When you palpate, you don't feel any crepitus or fluctuance. He has a strong pulse at both dorsal pedis and posterior tibial arteries. Labs reveal a normal WBC count. What is your diagnosis? What antibiotics would you start? |
| 2. A 72‐year‐old man is admitted for a lobectomy. About 6 days after his operation, while still on mechanical ventilation, he develops findings suggestive of pneumonia, based on a new right lower lobe infiltrate on chest x‐ray, increased secretions, and fever (101.1F). A blood sample and an endotracheal aspirate are sent for culture. He is empirically started on vancomycin and piperacillin/tazobactam. After 3 days of empiric antibiotics, he has had no additional fevers and has been extubated to room air. His WBC count has normalized. Blood cultures show no growth. The respiratory sample shows >25 PMNs and <10 epithelial cells; no organisms are seen on Gram stain, and there is no growth on culture. Would you make any changes to his antibiotic regimen at this time? If so, how would you justify the change? |
| 3. A 72‐year‐old man presented with a severe Clostridium difficile infection, which resulted in both respiratory and acute renal failure. He gradually improved with supportive care, oral vancomycin, and IV metronidazole. After over a month of being hospitalized in the ICU, his Foley was removed. He was subsequently found to have urinary retention, so he was straight catheterized. The urine obtained from the straight catheterization was cloudy. A urinalysis showed 53 WBCs, positive nitrite, and many bacteria. Urine culture grew >100K ESBL‐producing Escherichia coli. He wasn't having fevers. He had no leukocytosis and no signs or symptoms attributable to a UTI. What is you diagnosis? What antibiotics would you start? |
All interviews were audio recorded, transcribed, and deidentified. All transcripts were reviewed by the study's research assistant (A.R.C.) for accuracy and completeness.
An ID physician (D.L.) reviewed each transcript to determine whether the participant's stated plan for each case vignette was in accordance with IDSA guidelines. Participants were evaluated on their decision to prescribe antibiotics and their choice of agents.
Transcripts were also analyzed using emergent thematic analysis.[27, 28, 29] First, 2 members of the research team (D.L., A.R.C.) reviewed all interview transcripts and discussed general impressions. Next, the analytic team reread one‐fifth of the transcripts, assigning codes to the data line by line. Codes were discussed among team members to determine the most prominent themes. During this phase, codes were added, eliminated, and combined while applying the codes to the remaining transcripts.[30] The analysts then performed focused coding: finalized codes from the first phase were applied to each transcript. The 2 analysts performed focused coding individually on each transcript in a consecutive fashion and met after every 10 transcripts to ensure consistency in their coding for the prior 10 transcripts. Analysts discussed any discrepancies to reach a consensus. Evidence was sought that may call observations and classifications into question.[31] Theoretical saturation was reached through the 30 interviews, so additional enrollment was deemed unnecessary. NVivo version 9 software (QSR International, Cambridge, MA) was used to facilitate all coding and analysis.
RESULTS
All participants were physicians who practiced inpatient medicine. Ten were women, and 20 were men. The median age of participants was 34 years (interquartile range [IQR] 3042). Twenty were attending or staff physicians and had spent a median of 10 years (IQR 315) in clinical practice. Of these attending physicians, 3 practiced pulmonary/critical care, 16 were hospitalists without subspecialty training, and 1 was a hospitalist with ID training. Seven attending physicians practiced exclusively at hospital A, 8 practiced exclusively at hospital B, and 5 practiced at both A and B. The remaining 10 participants were physicians in training or residents, who practiced at both hospitals and were either in their third or fourth year of an internal medicine or medicine/pediatrics residency program.
All participants expressed general awareness of and familiarity with clinical guidelines. Most participants also found guidelines useful in their clinical practice. According to a resident:
[Guidelines] give you a framework for what to do. If somebody questions what you are doing, it is easy to point to the guidelines (24, resident).
The guidelines tend to keep us up‐to‐date, because unless you're focused on 1 system, it can be impossible to keep up with everything that is changing across the board (28, attending).
Most of the guidelines are well‐researched and are approved by a lot of people, so I don't usually go against them (6, attending).
Despite general agreement with guidelines in principle, our interviews identified 3 major barriers to following guidelines in practice: (1) lack of awareness of specific guideline recommendations, (2) tension between adhering to guidelines and the desire to individualize patient care, and (3) skepticism of certain guideline recommendations.
Lack of Awareness of Specific Guideline Recommendations
Although participants stated that they agreed with guidelines in general, many had difficulty describing specific guideline recommendations. Two residents acknowledged that their attending physicians did not seem familiar with guidelines. In response to hearing a guideline recommendation on HAP, a resident stated: I'm learning from them [the guidelines] as we speak. In addition, an attending admitted that she was not familiar with the guidelines:
Now that you're asking about [prescribing] outside of the clinical guidelines, I am sitting here thinking, I can't think of any [guidelines]. In fact, I will say that I am probably not aware of all of the clinical guidelines or changes in them in recent years (28, attending).
| Category | Case Vignette | Illustrative Quotation |
|---|---|---|
| ||
| 1. Lack of awareness of specific guideline recommendations | SSTI | 1. [Treating for] methicillin susceptible [Staphylococcus aureus] without MRSA? Oh, oh, wow.[and] not doing any gram‐negative coverage? I guess I am most discomfortable with that, but if that's the guideline [recommendation], yes, I will probably start following it (8, attending). |
| ASB | 2. I still think that he has a UTI, even though he doesn't necessarily have symptoms, because he was catheterized for so long. I also know after you reach a certain age, we generally treat you even though you don't necessarily have symptoms just because of all the risks associated with having bacteria in your urine (29, resident). | |
| 2. Tension between adhering to guidelines and individualizing patient care | SSTI | 3. If he had a known history of MRSA, if he had something else likea temporary dialysis lineor prosthetic joint or something else that if he were to get bacteremic with MRSA, it would cause him more operations and significant morbidity. [In that case], I might add vancomycin to his regimen from the beginning (12, resident). |
| HAP | 4. He has only 1 lung because he had part of his lung taken out. So, anyway, part of a lung taken out, and he's got a new infiltrate on his x‐ray, and he's got all the risk factors for pneumonia, so I would say generally I would leave him on antibiotics, but cut down (5, attending). | |
| 5. I would be concerned, especially since the patient was febrile. He did have a new infiltrate, and he seemed to have gotten better on antibiotics. I would definitely take it [the guideline recommendation] into consideration, but I would probably go ahead and give a course of oral antibiotics (6, attending). | ||
| ASB | 6. I would say this is a UTI. I'm sure the guidelines are going to say no, but since he was having retention and it wasn't a urine [culture] obtained from him having a Foley, I have less comfort calling it colonization. I would say that it is probably an infection. You don't see a lot of fevers in just a bladder infection (25, attending). | |
| 3. Skepticism of guideline recommendations | SSTI | 7. My big concern is methicillin‐resistant S aureus [MRSA]. I think personally I have some concern about not covering for MRSA (17, attending). |
| HAP | 8. Those are the guidelines, so I mean it is agreeable if there are studies that back it up. It is not something I feel that great about, but I could trial them off antibiotics and see how they do (14, resident). | |
| 9. I guess I would have to look more at the studies that led to the recommendations. I don't know that I would stop antibiotics completely because of how sick he was (29, resident). | ||
| ASB | 10. They [the guidelines] are tough to swallow, but we follow them because that is what the evidence shows. A lot of people would be very, very tempted to treat this (19, attending). | |
| 11. A guy has a catheter in for a month and has a ton of white cells in his urine and is growing something that is clearly pathogenic: he needs treatment. I do not care what the guidelines say (7, attending). | ||
Tension Between Adhering to Guidelines and Individualizing Patient Care
Although participants agreed with guidelines in principle, they had difficulty applying specific guideline recommendations to an individual patient's care. Many participants acknowledged modifying these recommendations to better suit the needs of a specific patient:
So guidelines are guidelines, but at the end of the day, it still comes down to individualizing patient care, and so sometimes those guidelines do not cover all the bases, and you still need to do what you think is best for the patient (10, attending).
The guidelines are not examining the patient, and I am examining the patient. So I will do what the guidelines say unless I feel that that patient needs more care (11, resident).
Fine, the study says something, but your objective evidence about what happened [is different]. He had this fever, he had these radiologic changes that are suggestive of pneumonia, you start antibiotics, he gets better, so that clinical scenario suggests an infection that is getting better (15, resident).
[I would treat outside of guidelines] when we are treating severe sepsis in somebody with advanced liver disease. Most of the clinical research programsexclude patients with advanced liver disease if they have risks for certain types of infections that are unusual (16, attending).
If it's a patient who is intubated and sick, they can't complain [about urinary symptoms], so the asymptomatic part of that goes out the window. For critically ill patients on ventilators that have bacteriuria, particularly if it's an ESBL [extended‐spectrum ‐lactamase], which is a bad bacteria, not wanting the patient to get sicker and not knowing if they are having symptoms of pain or both, I might consider treating in that kind of situation, even though they are afebrile and no [elevated] white count (20, attending).
Skepticism of Guideline Recommendations
A third barrier to guideline adherence was physicians' skepticism of what the guidelines recommend in certain cases. This skepticism stemmed, in part, from guidelines promoting a standardized, one size fits all approach even in situations when participants were more comfortable using their own judgment:
To me, the guidelines are adding a little bit more of a stress, because the guidelines are good for the more obvious things; they're more black and white, this than that. But clinical medicine is never like that. There is always something that makes it really gray, and some of it has to do with things that you're seeing because you're there with the patient that doesn't quite fit (25, attending).
Overall, guidelines are easy to follow when they have what to do as opposed to what not to do. We are trained to do something and fix something, so to not do anything is probably the hardest guideline to follow (11, resident).
It is just scary that he is growing such a bad bug and with a bad microbe, I would be worried about it progressing (11, resident).
Another acknowledged she would have difficulty stopping all antibiotics after only 3 days of therapy:
It would make me a little nervous following them [the guidelines]. I think I would finish the course because he had a fever, and we started him on antibiotics and he got better. I still feel clinically that he could have had pneumonia (25, attending).
DISCUSSION
In this study, we used case vignettes to identify barriers to following IDSA guidelines. Case vignettes require few resources and provide a common starting point for assessing physician decision making. Prior studies have used case vignettes to measure the quality of physicians' practice, including antibiotic prescribing.[17, 18, 19, 20, 21] Case vignettes have been used to assess antibiotic prescribing in the neonatal ICU and medical students' knowledge of upper respiratory tract infections.[21, 32] In 1 study, physicians who scored poorly on a series of case vignettes more frequently prescribed antibiotics inappropriately in actual practice.[17]
Using case vignettes, we identified 3 barriers to following IDSA guidelines on SSTI, HAP, and ASB: (1) lack of awareness of specific guideline recommendations, (2) tension between adhering to guidelines and the desire to individualize patient care, and (3) skepticism of certain guideline recommendations. These barriers were distributed unevenly across participants, highlighting the heterogeneity that exists even within a subgroup of hospital medicine physicians.
We identified lack of familiarity with guideline recommendations as a barrier in our sample of physicians. Interestingly, participants initially expressed agreement with guidelines, but when presented with case vignettes and asked for their own treatment recommendations, it became clear that their familiarity with guidelines was superficial. The disconnect between self‐reported practice and actual adherence has also been described in a separate study on healthcare‐associated pneumonia.[33] In all likelihood, participants genuinely believed that they were practicing guideline‐concordant care, but without a formal process for audit and feedback, their lack of adherence had never been raised as an issue.
A second barrier to guideline‐concordant care was the tension between individualizing patient care and adhering to standardized recommendations. On one hand, this tension is unavoidable and is inherent in the practice of medicine. However, participants' responses to our case vignettes suggested that they find their patients too different to fit into any standardized guideline. This tension was also discussed by Charani et al., who interviewed 39 healthcare professionals at 4 hospitals in the United Kingdom. These investigators found that physicians routinely consider their patients to be outside the recommendations of local evidence‐based policies.[34] Instead of referring to guidelines, physicians rely on their knowledge and clinical experience to guide their antibiotic prescribing.
The final barrier to guideline adherence that we identified was providers' skepticism of what the guidelines were recommending. Although physician discomfort with certain guideline recommendations may be alleviated by reviewing the literature informing the recommendation, education alone is often insufficient to change antibiotic prescribing practices.[35] Furthermore, part of this skepticism may reflect the lack of data from randomized controlled trials to support every guideline recommendation. For example, most guideline recommendations are based on low‐quality evidence.[36] The guideline recommendations presented in this study were based on moderate‐ to high‐quality evidence.[24, 25, 26]
To our knowledge, this study is 1 of the few to describe barriers to guideline‐concordant antibiotic use among inpatient medicine physicians in the United States. The barriers discussed above have also been described by investigators in Europe who studied antibiotic use among inpatient physicians.[34, 37, 38] These commonalities highlight the shared challenges faced by local initiatives to improve antibiotic prescribing.
Our findings suggest that the 2 hospitals we studied need more active interventions to improve antibiotic prescribing. One attractive idea is involving hospitalist physicians in future improvement efforts. Hospitalists are well positioned for this role; they care for a large proportion of hospital patients, they frequently prescribe antibiotics, andas a professionthey are committed to the efficient use of healthcare resources. Hospitalists could assist in the dissemination of local guidelines, the implementation of reliable processes to prompt antibiotic de‐escalation, and the development of local standards for documenting the indication for antibiotics and the planned duration of therapy.[39]
One limitation of this study was that we did not validate whether a physician's self‐reported response to the case vignettes correlated with his or her actual practice. Interviews were conducted by a nonphysician and kept confidential, but participants may nonetheless have been inclined to give socially desirable responses. However, this is less likely because participants readily admitted to not knowing and often not following guidelines. In addition, our case vignettes presented simplistic, hypothetical situations and were therefore less able to account for all determinants of antibiotic‐prescribing decisions. Prior research has shown that antibiotic‐prescribing decisions are influenced by a multitude of factors, including social norms and the physician's underlying beliefs and emotions.[34, 40] Antibiotic‐prescribing decisions can also be influenced by audit and feedback processes.[35] Thus, we acknowledge that our findings may have been different if this study was conducted exclusively at hospitals without an antimicrobial stewardship program.
In conclusion, case vignettes may be a useful tool to assess physician knowledge and acceptance of antibiotic‐prescribing guidelines on a local level. This study used case vignettes to identify key barriers to guideline‐concordant antibiotic use. Developing local interventions to target each of these barriers will be the next step in improving antibiotic prescribing.
Disclosure: This project was supported by a Project Development Team within the ICTSI NIH/NCRR grant number UL1TR001108. The authors report no conflicts of interest.
- , , , , . Variation in adherence with Global Initiative for Chronic Obstructive Lung Disease (GOLD) drug therapy guidelines: a retrospective actuarial claims data analysis. Curr Med Res Opin. 2011;27:1425–1429.
- , , , , . Guideline adherence in management of stable chronic obstructive pulmonary disease. Respir Med. 2013;107:1046–1052.
- , , , et al. Guideline‐concordant management of opioid therapy among human immunodeficiency virus (HIV)‐infected and uninfected veterans. J Pain. 2014;15:1130–1140.
- , , , et al. Primary care clinician adherence to guidelines for the management of chronic musculoskeletal pain: results from the study of the effectiveness of a collaborative approach to pain. Pain Med. 2011;12:1490–1501.
- , , , , . Receiving guideline‐concordant pharmacotherapy for major depression: impact on ambulatory and inpatient health service use. Can J Psychiatry. 2007;52:191–200.
- , , , , , . Guideline‐concordant antidepressant use among patients with major depressive disorder. Gen Hosp Psychiatry. 2010;32:360–367.
- , . Antibiotic prescribing to adults with sore throat in the United States, 1997–2010. JAMA Intern Med. 2014;174:138–140.
- , , , . National trends in visit rates and antibiotic prescribing for adults with acute sinusitis. Arch Intern Med. 2012;172:1513–1514.
- , , . Geographic variation in outpatient antibiotic prescribing among older adults. Arch Intern Med. 2012;172:1465–1471.
- , , , et al. Decreased antibiotic utilization after implementation of a guideline for inpatient cellulitis and cutaneous abscess. Arch Intern Med. 2011;171:1072–1079.
- , , , , , . Skin and soft‐tissue infections requiring hospitalization at an academic medical center: opportunities for antimicrobial stewardship. Clin Infect Dis. 2010;51:895–903.
- , , , , , . Inappropriate treatment of catheter‐associated asymptomatic bacteriuria in a tertiary care hospital. Clin Infect Dis. 2009;48:1182–1188.
- . Asymptomatic bacteriuria: when the treatment is worse than the disease. Nat Rev Urol. 2012;9:85–93.
- , , , et al. Improving outcomes in elderly patients with community‐acquired pneumonia by adhering to national guidelines: Community‐Acquired Pneumonia Organization International cohort study results. Arch Intern Med. 2009;169:1515–1524.
- , , , et al. Effectiveness of an Antimicrobial Stewardship Approach for Urinary Catheter‐Associated Asymptomatic Bacteriuria. JAMA Intern Med. 2015;175:1120–1127.
- , , , , . Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta‐analysis. BMJ. 2010;340:c2096.
- , , , et al. Do case vignettes accurately reflect antibiotic prescription? Infect Control Hosp Epidemiol. 2011;32:1003–1009.
- , , , et al. Antibiotic use: knowledge and perceptions in two university hospitals. J Antimicrob Chemother. 2011;66:936–940.
- , , , , . Comparison of vignettes, standardized patients, and chart abstraction: a prospective validation study of 3 methods for measuring quality. JAMA. 2000;283:1715–1722.
- , , , et al. Measuring the quality of physician practice by using clinical vignettes: a prospective validation study. Ann Intern Med. 2004;141:771–780.
- , , , et al. Clinical vignettes provide an understanding of antibiotic prescribing practices in neonatal intensive care units. Infect Control Hosp Epidemiol. 2011;32:597–602.
- . Sampling in qualitative inquiry. In: Crabtree BF, Miller WL, eds. Doing Qualitative Research. Thousand Oaks, CA: Sage; 1999:33–45.
- , , , , . Factors influencing antibiotic‐prescribing decisions among inpatient physicians: a qualitative investigation. Infect Control Hosp Epidemiol. 2015;36(9):1065–1072.
- , , , et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014;59:e10–e52.
- American Thoracic Society and the Infectious Disease Society of North America. The new American Thoracic Society/Infectious Disease Society of North America guidelines for the management of hospital‐acquired, ventilator‐associated and healthcare‐associated pneumonia: a current view and new complementary information. Curr Opin Crit Care. 2006;12:444–445.
- , , , et al. Infectious Diseases Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in adults. Clin Infect Dis. 2005;40:643–654.
- , . The dance of interpretation. In: Crabtree BF, Miller WL, eds. Doing Qualitative Research. Thousand Oaks, CA: Sage; 1999:127–143.
- , . Qualitative Data Analysis. Thousand Oaks, CA: Sage; 1994.
- . Research Methods in Anthropology: Qualitative and Quantitative Approaches. Walnut Creek, CA: AltaMira; 2002.
- . Constructing Grounded Theory: A Practical Guide Through Qualitative Analysis. Thousand Oaks, CA: Sage; 2006.
- , . The Discovery of Grounded Theory: Strategies for Qualitative Research. Hawthorne, NY: Aldine de Gruyter; 1967.
- , , . Knowledge of the principles of judicious antibiotic use for upper respiratory infections: a survey of senior medical students. South Med J. 2005;98:889–895.
- , , , et al. The HCAP gap: differences between self‐reported practice patterns and published guidelines for health care‐associated pneumonia. Clin Infect Dis. 2009;49:1868–1874.
- , , , et al. Understanding the determinants of antimicrobial prescribing within hospitals: the role of “prescribing etiquette”. Clin Infect Dis. 2013;57:188–196.
- , , , et al. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis. 2007;44:159–177.
- , , , , . Quality and strength of evidence of the Infectious Diseases Society of America clinical practice guidelines. Clin Infect Dis. 2010;51:1147–1156.
- , , , , . Opposing expectations and suboptimal use of a local antibiotic hospital guideline: a qualitative study. J Antimicrob Chemother. 2008;62:189–195.
- , , , , , . Barriers to optimal antibiotic use for community‐acquired pneumonia at hospitals: a qualitative study. Qual Saf Health Care. 2007;16:143–149.
- , , . Role of the hospitalist in antimicrobial stewardship: a review of work completed and description of a multisite collaborative. Clin Ther. 2013;35:751–757.
- , , , et al. Behavior change strategies to influence antimicrobial prescribing in acute care: a systematic review. Clin Infect Dis. 2011;53:651–662.
Clinical guidelines are prevalent in the field of medicine, but physicians do not consistently provide guideline‐concordant care. Nonadherence to guidelines has been documented for a variety of clinical conditions, including chronic obstructive pulmonary disease,[1, 2] pain management,[3, 4] and major depressive disorder.[5, 6]
Although several professional societies, including the Infectious Diseases Society of America (IDSA), have developed and disseminated guidelines on antibiotic use, adherence to antibiotic‐prescribing guidelines is inconsistent. Several studies have documented inappropriate antibiotic prescribing for specific infections, including acute respiratory infections,[7, 8, 9] cellulitis,[10, 11] and asymptomatic bacteriuria.[12, 13]
Improving adherence to guidelines on antibiotic use could have several benefits. For certain infections, guideline adherence has been shown to improve patient outcomes and reduce resource utilization.[10, 14, 15] In general, guidelines promote more judicious use of antibiotics by clarifying when an antibiotic is indicated, which antibiotics to prescribe, and duration of antibiotic therapy. The more judicious use of antibiotics decreases a given patient's risk of developing an antibiotic‐resistant infection and Clostridium difficileassociated diarrhea.[16] Judicious antibiotic use will also have societal benefits by slowing the spread of antibiotic‐resistant bacteria.
As part of a local effort to improve antibiotic use, we decided to present physicians with hypothetical cases of common clinical scenarios to identify barriers to following antibiotic‐prescribing guidelines. Previous investigators have used case vignettes to assess the quality of care physicians provide, including decisions about antibiotics.[17, 18, 19, 20, 21] We used case vignettes to assess physicians' familiarity with and acceptance of IDSA guidelines for 3 common infectious conditions: skin and soft tissue infections (SSTI), suspected hospital‐acquired pneumonia (HAP), and asymptomatic bacteriuria (ASB). The findings from our project were intended to inform local interventions to improve antibiotic prescribing.
METHODS
All interviews were conducted at 2 acute care hospitals in Indianapolis, Indiana: Sidney and Lois Eskenazi Hospital and the Richard Roudebush Veterans Affairs Medical Center (VAMC). Eskenazi Hospital is a 316‐bed safety‐net hospital for Marion County, Indiana. The Roudebush VAMC is a 209‐bed tertiary care facility that provides comprehensive medical care for 85,000 veterans. Both hospitals are academically affiliated with Indiana University's School of Medicine.
Both hospitals have empiric antibiotic‐prescribing guidelines printed in their annual antibiograms. These guidelines, developed by each hospital's pharmacy department and the local infectious disease (ID) physicians, are distributed annually as a pocket booklet. During this study, an antibiotic stewardship program was active at hospital A but not hospital B. As part of this program at hospital A, an ID physician reviewed inpatients on antibiotics twice a week and, with the help of inpatient team pharmacists, provided feedback to the frontline prescribers.
For this study, inpatient physicians who prescribe antibiotics at either facility were invited to participate in a 30‐minute confidential interview about their antibiotic‐prescribing habits. All invitations were sent through electronic mail. The target enrollment was 30 physicians, which is consistent with prior literature on qualitative sampling.[22] Sampling was purposeful to recruit a heterogeneous group of participants from both hospital sites. Although such a sampling strategy precluded us from making conclusions about individual subgroups, our intention was to obtain the broadest range of information and perspectives, thereby challenging our own preconceived understandings and biases.
The protocol and conduct of this study were reviewed and approved by the Indiana University Institutional Review Board. Participants read and provided signed informed consent. No compensation was provided to physician participants.
A research assistant (A.R.C.) trained in qualitative interviewing conducted all interviews.[23] These interviews covered social norms, perceptions of risk, self‐efficacy, knowledge, and acceptance of guidelines. At the end of the interview, each participant was asked to respond to 3 case vignettes (Table 1), which had been developed by an ID physician (D.L.) based on both local and IDSA guidelines.[24, 25, 26] Participants decided whether to prescribe antibiotics and, if so, which antibiotic to use. After their response, the interviewer read aloud specific recommendations from IDSA guidelines and asked, Would you feel comfortable applying this recommendation to your practice? Are there situations when you would not apply this recommendation?
|
| 1. A 40‐year‐old man with poorly controlled type 2 diabetes develops pain and redness over the dorsum of his foot. He presents to the emergency room the day after these symptoms started. He denies any recent penetrating injuries to his foot, including no animal bites, and denies any water exposure. At the time of presentation, his temperature is 101.1F, pulse 89, his blood pressure is 124/76, and his respiratory rate is 16. Tender edema, warmth, and erythema extend up to the pretibial area of his right lower leg. Fissures are present between his toes, but he has no foot ulcers. There are no blisters or purulence. When you palpate, you don't feel any crepitus or fluctuance. He has a strong pulse at both dorsal pedis and posterior tibial arteries. Labs reveal a normal WBC count. What is your diagnosis? What antibiotics would you start? |
| 2. A 72‐year‐old man is admitted for a lobectomy. About 6 days after his operation, while still on mechanical ventilation, he develops findings suggestive of pneumonia, based on a new right lower lobe infiltrate on chest x‐ray, increased secretions, and fever (101.1F). A blood sample and an endotracheal aspirate are sent for culture. He is empirically started on vancomycin and piperacillin/tazobactam. After 3 days of empiric antibiotics, he has had no additional fevers and has been extubated to room air. His WBC count has normalized. Blood cultures show no growth. The respiratory sample shows >25 PMNs and <10 epithelial cells; no organisms are seen on Gram stain, and there is no growth on culture. Would you make any changes to his antibiotic regimen at this time? If so, how would you justify the change? |
| 3. A 72‐year‐old man presented with a severe Clostridium difficile infection, which resulted in both respiratory and acute renal failure. He gradually improved with supportive care, oral vancomycin, and IV metronidazole. After over a month of being hospitalized in the ICU, his Foley was removed. He was subsequently found to have urinary retention, so he was straight catheterized. The urine obtained from the straight catheterization was cloudy. A urinalysis showed 53 WBCs, positive nitrite, and many bacteria. Urine culture grew >100K ESBL‐producing Escherichia coli. He wasn't having fevers. He had no leukocytosis and no signs or symptoms attributable to a UTI. What is you diagnosis? What antibiotics would you start? |
All interviews were audio recorded, transcribed, and deidentified. All transcripts were reviewed by the study's research assistant (A.R.C.) for accuracy and completeness.
An ID physician (D.L.) reviewed each transcript to determine whether the participant's stated plan for each case vignette was in accordance with IDSA guidelines. Participants were evaluated on their decision to prescribe antibiotics and their choice of agents.
Transcripts were also analyzed using emergent thematic analysis.[27, 28, 29] First, 2 members of the research team (D.L., A.R.C.) reviewed all interview transcripts and discussed general impressions. Next, the analytic team reread one‐fifth of the transcripts, assigning codes to the data line by line. Codes were discussed among team members to determine the most prominent themes. During this phase, codes were added, eliminated, and combined while applying the codes to the remaining transcripts.[30] The analysts then performed focused coding: finalized codes from the first phase were applied to each transcript. The 2 analysts performed focused coding individually on each transcript in a consecutive fashion and met after every 10 transcripts to ensure consistency in their coding for the prior 10 transcripts. Analysts discussed any discrepancies to reach a consensus. Evidence was sought that may call observations and classifications into question.[31] Theoretical saturation was reached through the 30 interviews, so additional enrollment was deemed unnecessary. NVivo version 9 software (QSR International, Cambridge, MA) was used to facilitate all coding and analysis.
RESULTS
All participants were physicians who practiced inpatient medicine. Ten were women, and 20 were men. The median age of participants was 34 years (interquartile range [IQR] 3042). Twenty were attending or staff physicians and had spent a median of 10 years (IQR 315) in clinical practice. Of these attending physicians, 3 practiced pulmonary/critical care, 16 were hospitalists without subspecialty training, and 1 was a hospitalist with ID training. Seven attending physicians practiced exclusively at hospital A, 8 practiced exclusively at hospital B, and 5 practiced at both A and B. The remaining 10 participants were physicians in training or residents, who practiced at both hospitals and were either in their third or fourth year of an internal medicine or medicine/pediatrics residency program.
All participants expressed general awareness of and familiarity with clinical guidelines. Most participants also found guidelines useful in their clinical practice. According to a resident:
[Guidelines] give you a framework for what to do. If somebody questions what you are doing, it is easy to point to the guidelines (24, resident).
The guidelines tend to keep us up‐to‐date, because unless you're focused on 1 system, it can be impossible to keep up with everything that is changing across the board (28, attending).
Most of the guidelines are well‐researched and are approved by a lot of people, so I don't usually go against them (6, attending).
Despite general agreement with guidelines in principle, our interviews identified 3 major barriers to following guidelines in practice: (1) lack of awareness of specific guideline recommendations, (2) tension between adhering to guidelines and the desire to individualize patient care, and (3) skepticism of certain guideline recommendations.
Lack of Awareness of Specific Guideline Recommendations
Although participants stated that they agreed with guidelines in general, many had difficulty describing specific guideline recommendations. Two residents acknowledged that their attending physicians did not seem familiar with guidelines. In response to hearing a guideline recommendation on HAP, a resident stated: I'm learning from them [the guidelines] as we speak. In addition, an attending admitted that she was not familiar with the guidelines:
Now that you're asking about [prescribing] outside of the clinical guidelines, I am sitting here thinking, I can't think of any [guidelines]. In fact, I will say that I am probably not aware of all of the clinical guidelines or changes in them in recent years (28, attending).
| Category | Case Vignette | Illustrative Quotation |
|---|---|---|
| ||
| 1. Lack of awareness of specific guideline recommendations | SSTI | 1. [Treating for] methicillin susceptible [Staphylococcus aureus] without MRSA? Oh, oh, wow.[and] not doing any gram‐negative coverage? I guess I am most discomfortable with that, but if that's the guideline [recommendation], yes, I will probably start following it (8, attending). |
| ASB | 2. I still think that he has a UTI, even though he doesn't necessarily have symptoms, because he was catheterized for so long. I also know after you reach a certain age, we generally treat you even though you don't necessarily have symptoms just because of all the risks associated with having bacteria in your urine (29, resident). | |
| 2. Tension between adhering to guidelines and individualizing patient care | SSTI | 3. If he had a known history of MRSA, if he had something else likea temporary dialysis lineor prosthetic joint or something else that if he were to get bacteremic with MRSA, it would cause him more operations and significant morbidity. [In that case], I might add vancomycin to his regimen from the beginning (12, resident). |
| HAP | 4. He has only 1 lung because he had part of his lung taken out. So, anyway, part of a lung taken out, and he's got a new infiltrate on his x‐ray, and he's got all the risk factors for pneumonia, so I would say generally I would leave him on antibiotics, but cut down (5, attending). | |
| 5. I would be concerned, especially since the patient was febrile. He did have a new infiltrate, and he seemed to have gotten better on antibiotics. I would definitely take it [the guideline recommendation] into consideration, but I would probably go ahead and give a course of oral antibiotics (6, attending). | ||
| ASB | 6. I would say this is a UTI. I'm sure the guidelines are going to say no, but since he was having retention and it wasn't a urine [culture] obtained from him having a Foley, I have less comfort calling it colonization. I would say that it is probably an infection. You don't see a lot of fevers in just a bladder infection (25, attending). | |
| 3. Skepticism of guideline recommendations | SSTI | 7. My big concern is methicillin‐resistant S aureus [MRSA]. I think personally I have some concern about not covering for MRSA (17, attending). |
| HAP | 8. Those are the guidelines, so I mean it is agreeable if there are studies that back it up. It is not something I feel that great about, but I could trial them off antibiotics and see how they do (14, resident). | |
| 9. I guess I would have to look more at the studies that led to the recommendations. I don't know that I would stop antibiotics completely because of how sick he was (29, resident). | ||
| ASB | 10. They [the guidelines] are tough to swallow, but we follow them because that is what the evidence shows. A lot of people would be very, very tempted to treat this (19, attending). | |
| 11. A guy has a catheter in for a month and has a ton of white cells in his urine and is growing something that is clearly pathogenic: he needs treatment. I do not care what the guidelines say (7, attending). | ||
Tension Between Adhering to Guidelines and Individualizing Patient Care
Although participants agreed with guidelines in principle, they had difficulty applying specific guideline recommendations to an individual patient's care. Many participants acknowledged modifying these recommendations to better suit the needs of a specific patient:
So guidelines are guidelines, but at the end of the day, it still comes down to individualizing patient care, and so sometimes those guidelines do not cover all the bases, and you still need to do what you think is best for the patient (10, attending).
The guidelines are not examining the patient, and I am examining the patient. So I will do what the guidelines say unless I feel that that patient needs more care (11, resident).
Fine, the study says something, but your objective evidence about what happened [is different]. He had this fever, he had these radiologic changes that are suggestive of pneumonia, you start antibiotics, he gets better, so that clinical scenario suggests an infection that is getting better (15, resident).
[I would treat outside of guidelines] when we are treating severe sepsis in somebody with advanced liver disease. Most of the clinical research programsexclude patients with advanced liver disease if they have risks for certain types of infections that are unusual (16, attending).
If it's a patient who is intubated and sick, they can't complain [about urinary symptoms], so the asymptomatic part of that goes out the window. For critically ill patients on ventilators that have bacteriuria, particularly if it's an ESBL [extended‐spectrum ‐lactamase], which is a bad bacteria, not wanting the patient to get sicker and not knowing if they are having symptoms of pain or both, I might consider treating in that kind of situation, even though they are afebrile and no [elevated] white count (20, attending).
Skepticism of Guideline Recommendations
A third barrier to guideline adherence was physicians' skepticism of what the guidelines recommend in certain cases. This skepticism stemmed, in part, from guidelines promoting a standardized, one size fits all approach even in situations when participants were more comfortable using their own judgment:
To me, the guidelines are adding a little bit more of a stress, because the guidelines are good for the more obvious things; they're more black and white, this than that. But clinical medicine is never like that. There is always something that makes it really gray, and some of it has to do with things that you're seeing because you're there with the patient that doesn't quite fit (25, attending).
Overall, guidelines are easy to follow when they have what to do as opposed to what not to do. We are trained to do something and fix something, so to not do anything is probably the hardest guideline to follow (11, resident).
It is just scary that he is growing such a bad bug and with a bad microbe, I would be worried about it progressing (11, resident).
Another acknowledged she would have difficulty stopping all antibiotics after only 3 days of therapy:
It would make me a little nervous following them [the guidelines]. I think I would finish the course because he had a fever, and we started him on antibiotics and he got better. I still feel clinically that he could have had pneumonia (25, attending).
DISCUSSION
In this study, we used case vignettes to identify barriers to following IDSA guidelines. Case vignettes require few resources and provide a common starting point for assessing physician decision making. Prior studies have used case vignettes to measure the quality of physicians' practice, including antibiotic prescribing.[17, 18, 19, 20, 21] Case vignettes have been used to assess antibiotic prescribing in the neonatal ICU and medical students' knowledge of upper respiratory tract infections.[21, 32] In 1 study, physicians who scored poorly on a series of case vignettes more frequently prescribed antibiotics inappropriately in actual practice.[17]
Using case vignettes, we identified 3 barriers to following IDSA guidelines on SSTI, HAP, and ASB: (1) lack of awareness of specific guideline recommendations, (2) tension between adhering to guidelines and the desire to individualize patient care, and (3) skepticism of certain guideline recommendations. These barriers were distributed unevenly across participants, highlighting the heterogeneity that exists even within a subgroup of hospital medicine physicians.
We identified lack of familiarity with guideline recommendations as a barrier in our sample of physicians. Interestingly, participants initially expressed agreement with guidelines, but when presented with case vignettes and asked for their own treatment recommendations, it became clear that their familiarity with guidelines was superficial. The disconnect between self‐reported practice and actual adherence has also been described in a separate study on healthcare‐associated pneumonia.[33] In all likelihood, participants genuinely believed that they were practicing guideline‐concordant care, but without a formal process for audit and feedback, their lack of adherence had never been raised as an issue.
A second barrier to guideline‐concordant care was the tension between individualizing patient care and adhering to standardized recommendations. On one hand, this tension is unavoidable and is inherent in the practice of medicine. However, participants' responses to our case vignettes suggested that they find their patients too different to fit into any standardized guideline. This tension was also discussed by Charani et al., who interviewed 39 healthcare professionals at 4 hospitals in the United Kingdom. These investigators found that physicians routinely consider their patients to be outside the recommendations of local evidence‐based policies.[34] Instead of referring to guidelines, physicians rely on their knowledge and clinical experience to guide their antibiotic prescribing.
The final barrier to guideline adherence that we identified was providers' skepticism of what the guidelines were recommending. Although physician discomfort with certain guideline recommendations may be alleviated by reviewing the literature informing the recommendation, education alone is often insufficient to change antibiotic prescribing practices.[35] Furthermore, part of this skepticism may reflect the lack of data from randomized controlled trials to support every guideline recommendation. For example, most guideline recommendations are based on low‐quality evidence.[36] The guideline recommendations presented in this study were based on moderate‐ to high‐quality evidence.[24, 25, 26]
To our knowledge, this study is 1 of the few to describe barriers to guideline‐concordant antibiotic use among inpatient medicine physicians in the United States. The barriers discussed above have also been described by investigators in Europe who studied antibiotic use among inpatient physicians.[34, 37, 38] These commonalities highlight the shared challenges faced by local initiatives to improve antibiotic prescribing.
Our findings suggest that the 2 hospitals we studied need more active interventions to improve antibiotic prescribing. One attractive idea is involving hospitalist physicians in future improvement efforts. Hospitalists are well positioned for this role; they care for a large proportion of hospital patients, they frequently prescribe antibiotics, andas a professionthey are committed to the efficient use of healthcare resources. Hospitalists could assist in the dissemination of local guidelines, the implementation of reliable processes to prompt antibiotic de‐escalation, and the development of local standards for documenting the indication for antibiotics and the planned duration of therapy.[39]
One limitation of this study was that we did not validate whether a physician's self‐reported response to the case vignettes correlated with his or her actual practice. Interviews were conducted by a nonphysician and kept confidential, but participants may nonetheless have been inclined to give socially desirable responses. However, this is less likely because participants readily admitted to not knowing and often not following guidelines. In addition, our case vignettes presented simplistic, hypothetical situations and were therefore less able to account for all determinants of antibiotic‐prescribing decisions. Prior research has shown that antibiotic‐prescribing decisions are influenced by a multitude of factors, including social norms and the physician's underlying beliefs and emotions.[34, 40] Antibiotic‐prescribing decisions can also be influenced by audit and feedback processes.[35] Thus, we acknowledge that our findings may have been different if this study was conducted exclusively at hospitals without an antimicrobial stewardship program.
In conclusion, case vignettes may be a useful tool to assess physician knowledge and acceptance of antibiotic‐prescribing guidelines on a local level. This study used case vignettes to identify key barriers to guideline‐concordant antibiotic use. Developing local interventions to target each of these barriers will be the next step in improving antibiotic prescribing.
Disclosure: This project was supported by a Project Development Team within the ICTSI NIH/NCRR grant number UL1TR001108. The authors report no conflicts of interest.
Clinical guidelines are prevalent in the field of medicine, but physicians do not consistently provide guideline‐concordant care. Nonadherence to guidelines has been documented for a variety of clinical conditions, including chronic obstructive pulmonary disease,[1, 2] pain management,[3, 4] and major depressive disorder.[5, 6]
Although several professional societies, including the Infectious Diseases Society of America (IDSA), have developed and disseminated guidelines on antibiotic use, adherence to antibiotic‐prescribing guidelines is inconsistent. Several studies have documented inappropriate antibiotic prescribing for specific infections, including acute respiratory infections,[7, 8, 9] cellulitis,[10, 11] and asymptomatic bacteriuria.[12, 13]
Improving adherence to guidelines on antibiotic use could have several benefits. For certain infections, guideline adherence has been shown to improve patient outcomes and reduce resource utilization.[10, 14, 15] In general, guidelines promote more judicious use of antibiotics by clarifying when an antibiotic is indicated, which antibiotics to prescribe, and duration of antibiotic therapy. The more judicious use of antibiotics decreases a given patient's risk of developing an antibiotic‐resistant infection and Clostridium difficileassociated diarrhea.[16] Judicious antibiotic use will also have societal benefits by slowing the spread of antibiotic‐resistant bacteria.
As part of a local effort to improve antibiotic use, we decided to present physicians with hypothetical cases of common clinical scenarios to identify barriers to following antibiotic‐prescribing guidelines. Previous investigators have used case vignettes to assess the quality of care physicians provide, including decisions about antibiotics.[17, 18, 19, 20, 21] We used case vignettes to assess physicians' familiarity with and acceptance of IDSA guidelines for 3 common infectious conditions: skin and soft tissue infections (SSTI), suspected hospital‐acquired pneumonia (HAP), and asymptomatic bacteriuria (ASB). The findings from our project were intended to inform local interventions to improve antibiotic prescribing.
METHODS
All interviews were conducted at 2 acute care hospitals in Indianapolis, Indiana: Sidney and Lois Eskenazi Hospital and the Richard Roudebush Veterans Affairs Medical Center (VAMC). Eskenazi Hospital is a 316‐bed safety‐net hospital for Marion County, Indiana. The Roudebush VAMC is a 209‐bed tertiary care facility that provides comprehensive medical care for 85,000 veterans. Both hospitals are academically affiliated with Indiana University's School of Medicine.
Both hospitals have empiric antibiotic‐prescribing guidelines printed in their annual antibiograms. These guidelines, developed by each hospital's pharmacy department and the local infectious disease (ID) physicians, are distributed annually as a pocket booklet. During this study, an antibiotic stewardship program was active at hospital A but not hospital B. As part of this program at hospital A, an ID physician reviewed inpatients on antibiotics twice a week and, with the help of inpatient team pharmacists, provided feedback to the frontline prescribers.
For this study, inpatient physicians who prescribe antibiotics at either facility were invited to participate in a 30‐minute confidential interview about their antibiotic‐prescribing habits. All invitations were sent through electronic mail. The target enrollment was 30 physicians, which is consistent with prior literature on qualitative sampling.[22] Sampling was purposeful to recruit a heterogeneous group of participants from both hospital sites. Although such a sampling strategy precluded us from making conclusions about individual subgroups, our intention was to obtain the broadest range of information and perspectives, thereby challenging our own preconceived understandings and biases.
The protocol and conduct of this study were reviewed and approved by the Indiana University Institutional Review Board. Participants read and provided signed informed consent. No compensation was provided to physician participants.
A research assistant (A.R.C.) trained in qualitative interviewing conducted all interviews.[23] These interviews covered social norms, perceptions of risk, self‐efficacy, knowledge, and acceptance of guidelines. At the end of the interview, each participant was asked to respond to 3 case vignettes (Table 1), which had been developed by an ID physician (D.L.) based on both local and IDSA guidelines.[24, 25, 26] Participants decided whether to prescribe antibiotics and, if so, which antibiotic to use. After their response, the interviewer read aloud specific recommendations from IDSA guidelines and asked, Would you feel comfortable applying this recommendation to your practice? Are there situations when you would not apply this recommendation?
|
| 1. A 40‐year‐old man with poorly controlled type 2 diabetes develops pain and redness over the dorsum of his foot. He presents to the emergency room the day after these symptoms started. He denies any recent penetrating injuries to his foot, including no animal bites, and denies any water exposure. At the time of presentation, his temperature is 101.1F, pulse 89, his blood pressure is 124/76, and his respiratory rate is 16. Tender edema, warmth, and erythema extend up to the pretibial area of his right lower leg. Fissures are present between his toes, but he has no foot ulcers. There are no blisters or purulence. When you palpate, you don't feel any crepitus or fluctuance. He has a strong pulse at both dorsal pedis and posterior tibial arteries. Labs reveal a normal WBC count. What is your diagnosis? What antibiotics would you start? |
| 2. A 72‐year‐old man is admitted for a lobectomy. About 6 days after his operation, while still on mechanical ventilation, he develops findings suggestive of pneumonia, based on a new right lower lobe infiltrate on chest x‐ray, increased secretions, and fever (101.1F). A blood sample and an endotracheal aspirate are sent for culture. He is empirically started on vancomycin and piperacillin/tazobactam. After 3 days of empiric antibiotics, he has had no additional fevers and has been extubated to room air. His WBC count has normalized. Blood cultures show no growth. The respiratory sample shows >25 PMNs and <10 epithelial cells; no organisms are seen on Gram stain, and there is no growth on culture. Would you make any changes to his antibiotic regimen at this time? If so, how would you justify the change? |
| 3. A 72‐year‐old man presented with a severe Clostridium difficile infection, which resulted in both respiratory and acute renal failure. He gradually improved with supportive care, oral vancomycin, and IV metronidazole. After over a month of being hospitalized in the ICU, his Foley was removed. He was subsequently found to have urinary retention, so he was straight catheterized. The urine obtained from the straight catheterization was cloudy. A urinalysis showed 53 WBCs, positive nitrite, and many bacteria. Urine culture grew >100K ESBL‐producing Escherichia coli. He wasn't having fevers. He had no leukocytosis and no signs or symptoms attributable to a UTI. What is you diagnosis? What antibiotics would you start? |
All interviews were audio recorded, transcribed, and deidentified. All transcripts were reviewed by the study's research assistant (A.R.C.) for accuracy and completeness.
An ID physician (D.L.) reviewed each transcript to determine whether the participant's stated plan for each case vignette was in accordance with IDSA guidelines. Participants were evaluated on their decision to prescribe antibiotics and their choice of agents.
Transcripts were also analyzed using emergent thematic analysis.[27, 28, 29] First, 2 members of the research team (D.L., A.R.C.) reviewed all interview transcripts and discussed general impressions. Next, the analytic team reread one‐fifth of the transcripts, assigning codes to the data line by line. Codes were discussed among team members to determine the most prominent themes. During this phase, codes were added, eliminated, and combined while applying the codes to the remaining transcripts.[30] The analysts then performed focused coding: finalized codes from the first phase were applied to each transcript. The 2 analysts performed focused coding individually on each transcript in a consecutive fashion and met after every 10 transcripts to ensure consistency in their coding for the prior 10 transcripts. Analysts discussed any discrepancies to reach a consensus. Evidence was sought that may call observations and classifications into question.[31] Theoretical saturation was reached through the 30 interviews, so additional enrollment was deemed unnecessary. NVivo version 9 software (QSR International, Cambridge, MA) was used to facilitate all coding and analysis.
RESULTS
All participants were physicians who practiced inpatient medicine. Ten were women, and 20 were men. The median age of participants was 34 years (interquartile range [IQR] 3042). Twenty were attending or staff physicians and had spent a median of 10 years (IQR 315) in clinical practice. Of these attending physicians, 3 practiced pulmonary/critical care, 16 were hospitalists without subspecialty training, and 1 was a hospitalist with ID training. Seven attending physicians practiced exclusively at hospital A, 8 practiced exclusively at hospital B, and 5 practiced at both A and B. The remaining 10 participants were physicians in training or residents, who practiced at both hospitals and were either in their third or fourth year of an internal medicine or medicine/pediatrics residency program.
All participants expressed general awareness of and familiarity with clinical guidelines. Most participants also found guidelines useful in their clinical practice. According to a resident:
[Guidelines] give you a framework for what to do. If somebody questions what you are doing, it is easy to point to the guidelines (24, resident).
The guidelines tend to keep us up‐to‐date, because unless you're focused on 1 system, it can be impossible to keep up with everything that is changing across the board (28, attending).
Most of the guidelines are well‐researched and are approved by a lot of people, so I don't usually go against them (6, attending).
Despite general agreement with guidelines in principle, our interviews identified 3 major barriers to following guidelines in practice: (1) lack of awareness of specific guideline recommendations, (2) tension between adhering to guidelines and the desire to individualize patient care, and (3) skepticism of certain guideline recommendations.
Lack of Awareness of Specific Guideline Recommendations
Although participants stated that they agreed with guidelines in general, many had difficulty describing specific guideline recommendations. Two residents acknowledged that their attending physicians did not seem familiar with guidelines. In response to hearing a guideline recommendation on HAP, a resident stated: I'm learning from them [the guidelines] as we speak. In addition, an attending admitted that she was not familiar with the guidelines:
Now that you're asking about [prescribing] outside of the clinical guidelines, I am sitting here thinking, I can't think of any [guidelines]. In fact, I will say that I am probably not aware of all of the clinical guidelines or changes in them in recent years (28, attending).
| Category | Case Vignette | Illustrative Quotation |
|---|---|---|
| ||
| 1. Lack of awareness of specific guideline recommendations | SSTI | 1. [Treating for] methicillin susceptible [Staphylococcus aureus] without MRSA? Oh, oh, wow.[and] not doing any gram‐negative coverage? I guess I am most discomfortable with that, but if that's the guideline [recommendation], yes, I will probably start following it (8, attending). |
| ASB | 2. I still think that he has a UTI, even though he doesn't necessarily have symptoms, because he was catheterized for so long. I also know after you reach a certain age, we generally treat you even though you don't necessarily have symptoms just because of all the risks associated with having bacteria in your urine (29, resident). | |
| 2. Tension between adhering to guidelines and individualizing patient care | SSTI | 3. If he had a known history of MRSA, if he had something else likea temporary dialysis lineor prosthetic joint or something else that if he were to get bacteremic with MRSA, it would cause him more operations and significant morbidity. [In that case], I might add vancomycin to his regimen from the beginning (12, resident). |
| HAP | 4. He has only 1 lung because he had part of his lung taken out. So, anyway, part of a lung taken out, and he's got a new infiltrate on his x‐ray, and he's got all the risk factors for pneumonia, so I would say generally I would leave him on antibiotics, but cut down (5, attending). | |
| 5. I would be concerned, especially since the patient was febrile. He did have a new infiltrate, and he seemed to have gotten better on antibiotics. I would definitely take it [the guideline recommendation] into consideration, but I would probably go ahead and give a course of oral antibiotics (6, attending). | ||
| ASB | 6. I would say this is a UTI. I'm sure the guidelines are going to say no, but since he was having retention and it wasn't a urine [culture] obtained from him having a Foley, I have less comfort calling it colonization. I would say that it is probably an infection. You don't see a lot of fevers in just a bladder infection (25, attending). | |
| 3. Skepticism of guideline recommendations | SSTI | 7. My big concern is methicillin‐resistant S aureus [MRSA]. I think personally I have some concern about not covering for MRSA (17, attending). |
| HAP | 8. Those are the guidelines, so I mean it is agreeable if there are studies that back it up. It is not something I feel that great about, but I could trial them off antibiotics and see how they do (14, resident). | |
| 9. I guess I would have to look more at the studies that led to the recommendations. I don't know that I would stop antibiotics completely because of how sick he was (29, resident). | ||
| ASB | 10. They [the guidelines] are tough to swallow, but we follow them because that is what the evidence shows. A lot of people would be very, very tempted to treat this (19, attending). | |
| 11. A guy has a catheter in for a month and has a ton of white cells in his urine and is growing something that is clearly pathogenic: he needs treatment. I do not care what the guidelines say (7, attending). | ||
Tension Between Adhering to Guidelines and Individualizing Patient Care
Although participants agreed with guidelines in principle, they had difficulty applying specific guideline recommendations to an individual patient's care. Many participants acknowledged modifying these recommendations to better suit the needs of a specific patient:
So guidelines are guidelines, but at the end of the day, it still comes down to individualizing patient care, and so sometimes those guidelines do not cover all the bases, and you still need to do what you think is best for the patient (10, attending).
The guidelines are not examining the patient, and I am examining the patient. So I will do what the guidelines say unless I feel that that patient needs more care (11, resident).
Fine, the study says something, but your objective evidence about what happened [is different]. He had this fever, he had these radiologic changes that are suggestive of pneumonia, you start antibiotics, he gets better, so that clinical scenario suggests an infection that is getting better (15, resident).
[I would treat outside of guidelines] when we are treating severe sepsis in somebody with advanced liver disease. Most of the clinical research programsexclude patients with advanced liver disease if they have risks for certain types of infections that are unusual (16, attending).
If it's a patient who is intubated and sick, they can't complain [about urinary symptoms], so the asymptomatic part of that goes out the window. For critically ill patients on ventilators that have bacteriuria, particularly if it's an ESBL [extended‐spectrum ‐lactamase], which is a bad bacteria, not wanting the patient to get sicker and not knowing if they are having symptoms of pain or both, I might consider treating in that kind of situation, even though they are afebrile and no [elevated] white count (20, attending).
Skepticism of Guideline Recommendations
A third barrier to guideline adherence was physicians' skepticism of what the guidelines recommend in certain cases. This skepticism stemmed, in part, from guidelines promoting a standardized, one size fits all approach even in situations when participants were more comfortable using their own judgment:
To me, the guidelines are adding a little bit more of a stress, because the guidelines are good for the more obvious things; they're more black and white, this than that. But clinical medicine is never like that. There is always something that makes it really gray, and some of it has to do with things that you're seeing because you're there with the patient that doesn't quite fit (25, attending).
Overall, guidelines are easy to follow when they have what to do as opposed to what not to do. We are trained to do something and fix something, so to not do anything is probably the hardest guideline to follow (11, resident).
It is just scary that he is growing such a bad bug and with a bad microbe, I would be worried about it progressing (11, resident).
Another acknowledged she would have difficulty stopping all antibiotics after only 3 days of therapy:
It would make me a little nervous following them [the guidelines]. I think I would finish the course because he had a fever, and we started him on antibiotics and he got better. I still feel clinically that he could have had pneumonia (25, attending).
DISCUSSION
In this study, we used case vignettes to identify barriers to following IDSA guidelines. Case vignettes require few resources and provide a common starting point for assessing physician decision making. Prior studies have used case vignettes to measure the quality of physicians' practice, including antibiotic prescribing.[17, 18, 19, 20, 21] Case vignettes have been used to assess antibiotic prescribing in the neonatal ICU and medical students' knowledge of upper respiratory tract infections.[21, 32] In 1 study, physicians who scored poorly on a series of case vignettes more frequently prescribed antibiotics inappropriately in actual practice.[17]
Using case vignettes, we identified 3 barriers to following IDSA guidelines on SSTI, HAP, and ASB: (1) lack of awareness of specific guideline recommendations, (2) tension between adhering to guidelines and the desire to individualize patient care, and (3) skepticism of certain guideline recommendations. These barriers were distributed unevenly across participants, highlighting the heterogeneity that exists even within a subgroup of hospital medicine physicians.
We identified lack of familiarity with guideline recommendations as a barrier in our sample of physicians. Interestingly, participants initially expressed agreement with guidelines, but when presented with case vignettes and asked for their own treatment recommendations, it became clear that their familiarity with guidelines was superficial. The disconnect between self‐reported practice and actual adherence has also been described in a separate study on healthcare‐associated pneumonia.[33] In all likelihood, participants genuinely believed that they were practicing guideline‐concordant care, but without a formal process for audit and feedback, their lack of adherence had never been raised as an issue.
A second barrier to guideline‐concordant care was the tension between individualizing patient care and adhering to standardized recommendations. On one hand, this tension is unavoidable and is inherent in the practice of medicine. However, participants' responses to our case vignettes suggested that they find their patients too different to fit into any standardized guideline. This tension was also discussed by Charani et al., who interviewed 39 healthcare professionals at 4 hospitals in the United Kingdom. These investigators found that physicians routinely consider their patients to be outside the recommendations of local evidence‐based policies.[34] Instead of referring to guidelines, physicians rely on their knowledge and clinical experience to guide their antibiotic prescribing.
The final barrier to guideline adherence that we identified was providers' skepticism of what the guidelines were recommending. Although physician discomfort with certain guideline recommendations may be alleviated by reviewing the literature informing the recommendation, education alone is often insufficient to change antibiotic prescribing practices.[35] Furthermore, part of this skepticism may reflect the lack of data from randomized controlled trials to support every guideline recommendation. For example, most guideline recommendations are based on low‐quality evidence.[36] The guideline recommendations presented in this study were based on moderate‐ to high‐quality evidence.[24, 25, 26]
To our knowledge, this study is 1 of the few to describe barriers to guideline‐concordant antibiotic use among inpatient medicine physicians in the United States. The barriers discussed above have also been described by investigators in Europe who studied antibiotic use among inpatient physicians.[34, 37, 38] These commonalities highlight the shared challenges faced by local initiatives to improve antibiotic prescribing.
Our findings suggest that the 2 hospitals we studied need more active interventions to improve antibiotic prescribing. One attractive idea is involving hospitalist physicians in future improvement efforts. Hospitalists are well positioned for this role; they care for a large proportion of hospital patients, they frequently prescribe antibiotics, andas a professionthey are committed to the efficient use of healthcare resources. Hospitalists could assist in the dissemination of local guidelines, the implementation of reliable processes to prompt antibiotic de‐escalation, and the development of local standards for documenting the indication for antibiotics and the planned duration of therapy.[39]
One limitation of this study was that we did not validate whether a physician's self‐reported response to the case vignettes correlated with his or her actual practice. Interviews were conducted by a nonphysician and kept confidential, but participants may nonetheless have been inclined to give socially desirable responses. However, this is less likely because participants readily admitted to not knowing and often not following guidelines. In addition, our case vignettes presented simplistic, hypothetical situations and were therefore less able to account for all determinants of antibiotic‐prescribing decisions. Prior research has shown that antibiotic‐prescribing decisions are influenced by a multitude of factors, including social norms and the physician's underlying beliefs and emotions.[34, 40] Antibiotic‐prescribing decisions can also be influenced by audit and feedback processes.[35] Thus, we acknowledge that our findings may have been different if this study was conducted exclusively at hospitals without an antimicrobial stewardship program.
In conclusion, case vignettes may be a useful tool to assess physician knowledge and acceptance of antibiotic‐prescribing guidelines on a local level. This study used case vignettes to identify key barriers to guideline‐concordant antibiotic use. Developing local interventions to target each of these barriers will be the next step in improving antibiotic prescribing.
Disclosure: This project was supported by a Project Development Team within the ICTSI NIH/NCRR grant number UL1TR001108. The authors report no conflicts of interest.
- , , , , . Variation in adherence with Global Initiative for Chronic Obstructive Lung Disease (GOLD) drug therapy guidelines: a retrospective actuarial claims data analysis. Curr Med Res Opin. 2011;27:1425–1429.
- , , , , . Guideline adherence in management of stable chronic obstructive pulmonary disease. Respir Med. 2013;107:1046–1052.
- , , , et al. Guideline‐concordant management of opioid therapy among human immunodeficiency virus (HIV)‐infected and uninfected veterans. J Pain. 2014;15:1130–1140.
- , , , et al. Primary care clinician adherence to guidelines for the management of chronic musculoskeletal pain: results from the study of the effectiveness of a collaborative approach to pain. Pain Med. 2011;12:1490–1501.
- , , , , . Receiving guideline‐concordant pharmacotherapy for major depression: impact on ambulatory and inpatient health service use. Can J Psychiatry. 2007;52:191–200.
- , , , , , . Guideline‐concordant antidepressant use among patients with major depressive disorder. Gen Hosp Psychiatry. 2010;32:360–367.
- , . Antibiotic prescribing to adults with sore throat in the United States, 1997–2010. JAMA Intern Med. 2014;174:138–140.
- , , , . National trends in visit rates and antibiotic prescribing for adults with acute sinusitis. Arch Intern Med. 2012;172:1513–1514.
- , , . Geographic variation in outpatient antibiotic prescribing among older adults. Arch Intern Med. 2012;172:1465–1471.
- , , , et al. Decreased antibiotic utilization after implementation of a guideline for inpatient cellulitis and cutaneous abscess. Arch Intern Med. 2011;171:1072–1079.
- , , , , , . Skin and soft‐tissue infections requiring hospitalization at an academic medical center: opportunities for antimicrobial stewardship. Clin Infect Dis. 2010;51:895–903.
- , , , , , . Inappropriate treatment of catheter‐associated asymptomatic bacteriuria in a tertiary care hospital. Clin Infect Dis. 2009;48:1182–1188.
- . Asymptomatic bacteriuria: when the treatment is worse than the disease. Nat Rev Urol. 2012;9:85–93.
- , , , et al. Improving outcomes in elderly patients with community‐acquired pneumonia by adhering to national guidelines: Community‐Acquired Pneumonia Organization International cohort study results. Arch Intern Med. 2009;169:1515–1524.
- , , , et al. Effectiveness of an Antimicrobial Stewardship Approach for Urinary Catheter‐Associated Asymptomatic Bacteriuria. JAMA Intern Med. 2015;175:1120–1127.
- , , , , . Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta‐analysis. BMJ. 2010;340:c2096.
- , , , et al. Do case vignettes accurately reflect antibiotic prescription? Infect Control Hosp Epidemiol. 2011;32:1003–1009.
- , , , et al. Antibiotic use: knowledge and perceptions in two university hospitals. J Antimicrob Chemother. 2011;66:936–940.
- , , , , . Comparison of vignettes, standardized patients, and chart abstraction: a prospective validation study of 3 methods for measuring quality. JAMA. 2000;283:1715–1722.
- , , , et al. Measuring the quality of physician practice by using clinical vignettes: a prospective validation study. Ann Intern Med. 2004;141:771–780.
- , , , et al. Clinical vignettes provide an understanding of antibiotic prescribing practices in neonatal intensive care units. Infect Control Hosp Epidemiol. 2011;32:597–602.
- . Sampling in qualitative inquiry. In: Crabtree BF, Miller WL, eds. Doing Qualitative Research. Thousand Oaks, CA: Sage; 1999:33–45.
- , , , , . Factors influencing antibiotic‐prescribing decisions among inpatient physicians: a qualitative investigation. Infect Control Hosp Epidemiol. 2015;36(9):1065–1072.
- , , , et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014;59:e10–e52.
- American Thoracic Society and the Infectious Disease Society of North America. The new American Thoracic Society/Infectious Disease Society of North America guidelines for the management of hospital‐acquired, ventilator‐associated and healthcare‐associated pneumonia: a current view and new complementary information. Curr Opin Crit Care. 2006;12:444–445.
- , , , et al. Infectious Diseases Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in adults. Clin Infect Dis. 2005;40:643–654.
- , . The dance of interpretation. In: Crabtree BF, Miller WL, eds. Doing Qualitative Research. Thousand Oaks, CA: Sage; 1999:127–143.
- , . Qualitative Data Analysis. Thousand Oaks, CA: Sage; 1994.
- . Research Methods in Anthropology: Qualitative and Quantitative Approaches. Walnut Creek, CA: AltaMira; 2002.
- . Constructing Grounded Theory: A Practical Guide Through Qualitative Analysis. Thousand Oaks, CA: Sage; 2006.
- , . The Discovery of Grounded Theory: Strategies for Qualitative Research. Hawthorne, NY: Aldine de Gruyter; 1967.
- , , . Knowledge of the principles of judicious antibiotic use for upper respiratory infections: a survey of senior medical students. South Med J. 2005;98:889–895.
- , , , et al. The HCAP gap: differences between self‐reported practice patterns and published guidelines for health care‐associated pneumonia. Clin Infect Dis. 2009;49:1868–1874.
- , , , et al. Understanding the determinants of antimicrobial prescribing within hospitals: the role of “prescribing etiquette”. Clin Infect Dis. 2013;57:188–196.
- , , , et al. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis. 2007;44:159–177.
- , , , , . Quality and strength of evidence of the Infectious Diseases Society of America clinical practice guidelines. Clin Infect Dis. 2010;51:1147–1156.
- , , , , . Opposing expectations and suboptimal use of a local antibiotic hospital guideline: a qualitative study. J Antimicrob Chemother. 2008;62:189–195.
- , , , , , . Barriers to optimal antibiotic use for community‐acquired pneumonia at hospitals: a qualitative study. Qual Saf Health Care. 2007;16:143–149.
- , , . Role of the hospitalist in antimicrobial stewardship: a review of work completed and description of a multisite collaborative. Clin Ther. 2013;35:751–757.
- , , , et al. Behavior change strategies to influence antimicrobial prescribing in acute care: a systematic review. Clin Infect Dis. 2011;53:651–662.
- , , , , . Variation in adherence with Global Initiative for Chronic Obstructive Lung Disease (GOLD) drug therapy guidelines: a retrospective actuarial claims data analysis. Curr Med Res Opin. 2011;27:1425–1429.
- , , , , . Guideline adherence in management of stable chronic obstructive pulmonary disease. Respir Med. 2013;107:1046–1052.
- , , , et al. Guideline‐concordant management of opioid therapy among human immunodeficiency virus (HIV)‐infected and uninfected veterans. J Pain. 2014;15:1130–1140.
- , , , et al. Primary care clinician adherence to guidelines for the management of chronic musculoskeletal pain: results from the study of the effectiveness of a collaborative approach to pain. Pain Med. 2011;12:1490–1501.
- , , , , . Receiving guideline‐concordant pharmacotherapy for major depression: impact on ambulatory and inpatient health service use. Can J Psychiatry. 2007;52:191–200.
- , , , , , . Guideline‐concordant antidepressant use among patients with major depressive disorder. Gen Hosp Psychiatry. 2010;32:360–367.
- , . Antibiotic prescribing to adults with sore throat in the United States, 1997–2010. JAMA Intern Med. 2014;174:138–140.
- , , , . National trends in visit rates and antibiotic prescribing for adults with acute sinusitis. Arch Intern Med. 2012;172:1513–1514.
- , , . Geographic variation in outpatient antibiotic prescribing among older adults. Arch Intern Med. 2012;172:1465–1471.
- , , , et al. Decreased antibiotic utilization after implementation of a guideline for inpatient cellulitis and cutaneous abscess. Arch Intern Med. 2011;171:1072–1079.
- , , , , , . Skin and soft‐tissue infections requiring hospitalization at an academic medical center: opportunities for antimicrobial stewardship. Clin Infect Dis. 2010;51:895–903.
- , , , , , . Inappropriate treatment of catheter‐associated asymptomatic bacteriuria in a tertiary care hospital. Clin Infect Dis. 2009;48:1182–1188.
- . Asymptomatic bacteriuria: when the treatment is worse than the disease. Nat Rev Urol. 2012;9:85–93.
- , , , et al. Improving outcomes in elderly patients with community‐acquired pneumonia by adhering to national guidelines: Community‐Acquired Pneumonia Organization International cohort study results. Arch Intern Med. 2009;169:1515–1524.
- , , , et al. Effectiveness of an Antimicrobial Stewardship Approach for Urinary Catheter‐Associated Asymptomatic Bacteriuria. JAMA Intern Med. 2015;175:1120–1127.
- , , , , . Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta‐analysis. BMJ. 2010;340:c2096.
- , , , et al. Do case vignettes accurately reflect antibiotic prescription? Infect Control Hosp Epidemiol. 2011;32:1003–1009.
- , , , et al. Antibiotic use: knowledge and perceptions in two university hospitals. J Antimicrob Chemother. 2011;66:936–940.
- , , , , . Comparison of vignettes, standardized patients, and chart abstraction: a prospective validation study of 3 methods for measuring quality. JAMA. 2000;283:1715–1722.
- , , , et al. Measuring the quality of physician practice by using clinical vignettes: a prospective validation study. Ann Intern Med. 2004;141:771–780.
- , , , et al. Clinical vignettes provide an understanding of antibiotic prescribing practices in neonatal intensive care units. Infect Control Hosp Epidemiol. 2011;32:597–602.
- . Sampling in qualitative inquiry. In: Crabtree BF, Miller WL, eds. Doing Qualitative Research. Thousand Oaks, CA: Sage; 1999:33–45.
- , , , , . Factors influencing antibiotic‐prescribing decisions among inpatient physicians: a qualitative investigation. Infect Control Hosp Epidemiol. 2015;36(9):1065–1072.
- , , , et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014;59:e10–e52.
- American Thoracic Society and the Infectious Disease Society of North America. The new American Thoracic Society/Infectious Disease Society of North America guidelines for the management of hospital‐acquired, ventilator‐associated and healthcare‐associated pneumonia: a current view and new complementary information. Curr Opin Crit Care. 2006;12:444–445.
- , , , et al. Infectious Diseases Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in adults. Clin Infect Dis. 2005;40:643–654.
- , . The dance of interpretation. In: Crabtree BF, Miller WL, eds. Doing Qualitative Research. Thousand Oaks, CA: Sage; 1999:127–143.
- , . Qualitative Data Analysis. Thousand Oaks, CA: Sage; 1994.
- . Research Methods in Anthropology: Qualitative and Quantitative Approaches. Walnut Creek, CA: AltaMira; 2002.
- . Constructing Grounded Theory: A Practical Guide Through Qualitative Analysis. Thousand Oaks, CA: Sage; 2006.
- , . The Discovery of Grounded Theory: Strategies for Qualitative Research. Hawthorne, NY: Aldine de Gruyter; 1967.
- , , . Knowledge of the principles of judicious antibiotic use for upper respiratory infections: a survey of senior medical students. South Med J. 2005;98:889–895.
- , , , et al. The HCAP gap: differences between self‐reported practice patterns and published guidelines for health care‐associated pneumonia. Clin Infect Dis. 2009;49:1868–1874.
- , , , et al. Understanding the determinants of antimicrobial prescribing within hospitals: the role of “prescribing etiquette”. Clin Infect Dis. 2013;57:188–196.
- , , , et al. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis. 2007;44:159–177.
- , , , , . Quality and strength of evidence of the Infectious Diseases Society of America clinical practice guidelines. Clin Infect Dis. 2010;51:1147–1156.
- , , , , . Opposing expectations and suboptimal use of a local antibiotic hospital guideline: a qualitative study. J Antimicrob Chemother. 2008;62:189–195.
- , , , , , . Barriers to optimal antibiotic use for community‐acquired pneumonia at hospitals: a qualitative study. Qual Saf Health Care. 2007;16:143–149.
- , , . Role of the hospitalist in antimicrobial stewardship: a review of work completed and description of a multisite collaborative. Clin Ther. 2013;35:751–757.
- , , , et al. Behavior change strategies to influence antimicrobial prescribing in acute care: a systematic review. Clin Infect Dis. 2011;53:651–662.
© 2015 Society of Hospital Medicine
Pharmacist Impact on Transitional Care
Hospital readmissions have a significant impact on the healthcare system. Medicare data suggest a 19% all‐cause 30‐day readmission rate, of which 47% may be preventable.[1, 2] The Centers for Medicare & Medicaid Services continue to expand their criteria of disease states that will be penalized for readmissions, now reducing hospital reimbursement rates up to 3%. Pharmacists, by optimizing patient utilization of medications, can play a valuable role in contributing to preventing readmissions.[3]
Lack of acceptable transitional care is a serious problem that is consistently identified in the literature.[4] Transitional care involves 3 domains of transfer: information, education, and destination. A breakdown in any of these components can negatively impact patients and their caregivers.
Prior studies consistently demonstrated a high likelihood of adverse drug events (ADEs) and patients' lack of knowledge regarding medications postdischarge, both of which can lead to readmission. Forster and colleagues found that 19% to 23% of patients experienced an ADE within 5 weeks of discharge from an inpatient visit, 66% to 72% of which were drug related, and approximately one‐third were deemed preventable.[5, 6] One survey found that less than 60% of patients knew the indication for a new medication prescribed at discharge, whereas only 12% reported knowledge of an anticipated ADE.[7]
Pharmacists can play a large role in the information and education aspect of transitional care. Previous studies demonstrate that pharmacist involvement in the discharge process can reduce the incidence of ADEs and have a positive impact on patient satisfaction. There are conflicting data regarding the effect of comprehensive medication education and follow‐up calls by pharmacy team members on ADEs and medication errors (MEs).[3, 8, 9] Although overall pharmacist participation has shown positive patient‐related outcomes, the impact of pharmacists' involvement on readmissions has not been consistently demonstrated.[10, 11, 12, 13, 14]
Our study evaluated the impact of the pharmacy team in the transitions‐of‐care settings in a unique combination utilizing the pharmacist during medication reconciliation, discharge, and with 3 follow‐up phone call interactions postdischarge. Our study was designed to evaluate the impact of intensive pharmacist involvement during the acute care admission as well as for a 30‐day time period postdischarge on both ADEs and readmissions.
METHODS
All patients were admitted to hospitalist‐based internal medicine units at Northwestern Memorial Hospital, an 894‐bed academic medical center located in Chicago, Illinois. Patients were randomized by study investigators using a random number generator to either the usual care or intervention arms and then evaluated each day for eligibility to participate in the study. Patients remained blinded throughout the study. Patients met inclusion criteria if they were discharged to home and either discharged on greater than 3 scheduled prescription medications or discharged with at least 1 high‐risk medication. High‐risk medications were classified as anticoagulants, antiplatelets (eg, aspirin and clopidogrel), hypoglycemic agents (eg, insulin), immunosuppressants, or anti‐infectives. Patients also needed to participate in a minimum of 1 postdischarge phone call or experience an emergency department (ED) visit or readmission within 30 days of discharge to meet inclusion criteria. Exclusion criteria included: impaired cognition based on Mini‐Cog screening assessment scale, unable or unwilling to provide informed consent, lack of a personal phone number, nonEnglish speaking, subsequent elective readmission within 30 days of initial visit, more than 3 previous hospital admissions in the past 2 months, palliative care or home/skilled nursing hospice, anticipated length of survival less than 3 months, discharged within 24 hours of admission, discharged against medical advice, or discharged before medication education was conducted (Figure 1). Patients who met inclusion criteria provided informed consent, received a Mini‐Cog screening assessment, and were given the Rapid Estimate of Adult Literacy in Medicine revised (REALM‐R) assessment to evaluate health literacy. The REALM‐R is a word recognition test designed to identify patients at risk for poor health literacy skills. Patients with REALM‐R scores of 6 or less are considered to have low health literacy.[15] Patients were randomized to receive either the usual care or pharmacist‐directed medication evaluation and management as described in Table 1. Patients included in the study were contacted by phone postdischarge, with 3 attempts on consecutive days. Patients who were readmitted as an inpatient or had an ED visit were not contacted for the study after that point.
| Admission Medication Reconciliation | Hospitalist (Confirmation by Pharmacist Reviewing the History and Physical Note in Electronic Medical Record) | Performed by Pharmacy Team Member Face to Face |
|---|---|---|
| ||
| Discharge medication reconciliation | Hospitalist | Pharmacy team member |
| Discharge medication education | Hospitalist and/or nurse | Pharmacy team member |
| Individualized medication plan | No | Yes |
| Postdischarge callback day 3 | No | Yes |
| Postdischarge callback day 14 | No | Yes |
| Postdischarge callback day 30 | Yes | Yes |
| Postdischarge call assessment topic(s) | ADEs/MEs, ED visits, inpatient readmissions | ADEs/MEs, ED visits, inpatient readmissions clarify pharmacy/discharge plan, resolve medication‐related issues, identify/overcome adherence barriers |
Patients enrolled in the control group received the usual standard of care by a clinical pharmacist. This included a medication reconciliation completed from the admitting physician's patient history and physical and medication counseling provided by the physician or nursing staff at discharge. Patients were not interviewed face‐to‐face on admission and did not receive discharge counseling by a pharmacy team member. Patients were assessed daily by the pharmacist for evaluation of the pharmacotherapy plans and presence of MEs or safety‐related concerns. The control group received 1 postdischarge phone call from a pharmacist at day 30 to assess for study endpoints of ADEs, MEs, ED visit, and readmission only. The endpoints of ADEs and MEs were determined by professional judgment by the clinical pharmacist based on an algorithm similar to National Coordinating Council for Medication Error Reporting and Prevention, although a specific tool was not utilized.
The study group received face‐to‐face medication reconciliation on admission by a pharmacist or a pharmacy student. Prior to discharge, a personalized medication plan was created by the pharmacist and discussed with the physician. Medication discrepancies were addressed prior to the discharge instructions being given and discussed with the patient. Medication counseling was performed at discharge by the pharmacist or pharmacy student. Patients received 3 phone calls at 3, 14, and 30 days postdischarge. The presence of ADEs and MEs were evaluated during each phone call. The patients were asked to confirm their medication regimens including drug, indication, dose, route, and frequency. They were also asked questions regarding possible side effects, new symptoms, and any changes to their current therapy. The calls focused on clarifying the pharmacy discharge plan, resolving any unanswered questions or medication‐related issues, identifying and overcoming any barriers to adherence, and assistance with providing patients access to medications by contacting pharmacies and physicians to resolve and troubleshoot further prescription claims and clarifications. Pharmacists performed all postdischarge phone calls. Pharmacy students were able to provide face‐to‐face medication reconciliation upon admission and discharge counseling under the supervision of the pharmacist for the intervention arm.
The patient Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) responses to the medication domain question, Did you clearly understand the purpose for taking each of your medications at the time of discharge? were collected for the 2 designated hospitalist units for both the control and study groups. HCAHPS scores were collected at the 6 months point prior to the study initiation and throughout the 6‐month study period for the control and intervention groups. A physician and 2 pharmacists, who were blinded to the study randomization and results, assessed all Northwestern Memorial Hospital readmissions to determine if the readmissions were medication‐related or not.
This study obtained institutional review board approval from Northwestern University.
Data Collected
Data collected from all patients included demographics (age, sex), payer, reason for admission, number of medications at time of discharge, Charlson Comorbidity Index score, number of high‐risk medications prescribed at time of discharge, length of stay, REALM‐R score, ADEs, inpatient readmission or ED visit, and the reason for readmission or ED visit. Only the first occurrence was counted for patients with both an ED visit and an inpatient readmission. It was estimated that a sample size of 150 patients in each group would provide 80% power to demonstrate a 20% improvement in ADE rates in the study group. Data were analyzed utilizing Fischer exact, 2, and Student t tests, and multivariate logistic regression as appropriate. Analyses were performed using SAS version 9.4 (SAS Institute, Inc., Cary, NC).
RESULTS
Over the course of 7 months, 341 patients were enrolled in the study, 189 in the control arm and 152 in the study arm. Forty‐eight patients in the control group and 15 patients in the study group were lost to follow‐up. The final analysis included 278 patients, 141 in the control group and 137 in the study group. Patients were eligible for study inclusion if they received at least 1 phone call, which resulted in more patients being lost to follow‐up in the control arm due to fewer total phone call attempts. Demographic and disposition data for the control and study groups are shown in Table 2. Baseline characteristics between the 2 groups were similar with the exception of total medications at time of discharge. The control group had more total medications at discharge compared to the study group (7.2 vs 6.4, P=0.04). The number of high‐risk medications and the number of scheduled medications were similar between both groups. During medication reconciliation, 380 discrepancies (46.2%) were found in the study group compared to 205 (19.9%) in the control group (P<0.0001). The higher number of identified discrepancies in the study group was expected due to the fact that the pharmacist did not complete a face‐to‐face medication history in the control patients. The average length of stay, REALM‐R scores, and reason for admissions were similar between the 2 groups (Table 2).
| Study, N=137 | Control, N=141 | P Value | |
|---|---|---|---|
| |||
| Sex, male | 52 (37.95%) | 59 (41.8%) | 0.54 |
| Average age, y | 55.4 | 55.8 | 0.87 |
| Average length of stay, d | 5.4 (range, 1104) | 4.6 (range, 028) | 0.67 |
| Average REALM‐R score (range, 08) | 6.8 | 6.7 | 0.67 |
| Average total no. of medications | 6.4 | 7.2 | 0.04 |
| Average no. of scheduled medications | 5.7 | 6.2 | 0.15 |
| Average no. of high‐risk category medications | 2.2 | 2.3 | 0.64 |
| Reason for admission | |||
| Cardiovascular disease | 5 (3.4%) | 15 (8.3%) | 0.035 |
| Pneumonia | 11 (7.5%) | 8 (4.4%) | 0.48 |
| Respiratory | 11 (7.5%) | 9 (5%) | 0.65 |
| Infectious disease | 39 (26.5%) | 53 (29.3%) | 0.13 |
| Gastrointestinal | 25 (17%) | 28 (15.5%) | 0.13 |
| Endocrine | 20 (13.6%) | 34 (18.8%) | 0.76 |
| Genitourinary | 0 (0%) | 0 (0%) | 0.05 |
| Hematological | 19 (12.9%) | 20 (11%) | 1 |
| Injury | 10 (6.8%) | 14 (7.7%) | 1 |
| Neurological | 2 (1.4%) | 0 (0%) | 0.52 |
| Heart failure | 4 (2.7%) | 0 (0%) | 0.24 |
| Myocardial infarction | 0 (0%) | 0 (0%) | 0.58 |
| Mental/substance abuse | 1 (0.7%) | 0 (0%) | 1 |
A total of 55 patients (39%) in the control arm were readmitted to an inpatient hospital or had an ED visit within 30‐days postdischarge compared to 34 patients (24.8%) in the study group (P=0.001) (Table 3). Of the patients readmitted to the ED, 21 were enrolled in the control arm (14.8%) compared to only 6 patients in the study arm (4.4%) (P=0.005). Reviewers concluded that 24% of the control group readmissions were medication‐related versus 23% of the study group (P=1.0). In total, 78 out of 89 readmissions were to Northwestern Memorial Hospital. Medication‐related causes to outside institutions were not evaluated. The causes for all readmissions were not evaluated.
| Study Group, n=137 | Control Group, n=141 | P Value | |
|---|---|---|---|
| |||
| Composite inpatient readmission and ED visit | 34 (24.8%) | 55 (38.7%) | 0.001 |
| ED visits | 6 (4.4%) | 21 (14.8%) | 0.005 |
| Inpatient readmissions | 28 (20.4%) | 34 (23.9%) | 0.43 |
| Medication‐related readmissions | 8 (23.5%) | 13 (23.6%) | 1.0 |
| ADEs/MEs reported at 30‐day phone call | 11/84 patients | 18/86 patients | 0.22 |
| Days to readmission/ED visit | 7.9 (SD 12.5) | 13.2 (SD 9.61) | 0.03 |
| Preintervention: HCAHPS scores pertaining to knowledge of indication of medication question preintervention | 47% | ||
| Postintervention: HCAHPS scores pertaining to knowledge of indication of medication question postintervention | 56% | ||
A sensitivity analysis was undertaken to understand the impact of the lost to follow‐up rate in both the control and study groups. Undertaking an assumption that all 15 patients lost to follow‐up in the study group were readmitted and that 15 of 48 patients lost to follow‐up in the control group were readmitted, the intervention continued to show a significant benefit in reduction of composite ED and inpatient readmissions (35.7% study group vs 49.6% control group, P=0.022)
Multivariate logistic regression analysis that controlled for Charlson Comorbidity Index score, length of stay, total number of medications on discharge, and payer type showed an adjusted odds ratio of 0.55 (95% confidence interval [CI]: 0.32‐0.94) in the intervention cohort compared to controls for the combined endpoint of readmission and ED visit within 30‐days postdischarge. The adjusted odds ratio for 30‐day readmission alone was 0.88 (95% CI: 0.49‐1.61).
Eighteen of the 86 control patients who received a 30‐day postdischarge phone call experienced an ADE or ME compared to 11 of the 83 study patients (P=0.22). Patient satisfaction scores of both designated units as represented by the HCAHPS score in the medication knowledge domain increased from the prestudy period. Patients selected agree or strongly agree only 47% of the time at the 6‐month prestudy point compared to 56% of the time during the 6‐month study period.
DISCUSSION
Although previous studies show conflicting results regarding the impact of pharmacist interventions on readmissions, our study demonstrated a decrease in the composite measure of inpatient readmissions and ED visits. Its success stresses the need for a comprehensive approach that contains continuity of care by healthcare providers to reconcile and manage medications throughout the hospital stay, extending up to a full month postdischarge with multiple phone calls. This included (1) face‐to‐face medication reconciliation on admission, (2) development of a personalized medication plan discussed with the patient's physician, (3) addressing any medication discrepancies to the discharge instructions being given to the patient, (4) medication counseling performed at discharge, and (5) 3 postdischarge phone calls at 3, 14, and 30 days.
A study conducted in 2001 analyzed the Medicare Current Beneficiary Survey (MCBS) and found that living alone, having limited education, and lack of self‐management skills have significant associations with early readmission.[16] Approximately 80 million Americans have limited health literacy and are associated with poor health outcomes and healthcare utilization as seen in a review completed by Berkman and colleagues.[17] Because no difference was found between both groups, it would suggest health literacy did not influence or bias the study group. Additionally, no statistically different medication issues, such as total number of medications or rates of ADEs and MEs, were identified in the patients of this study. This may be explained by the small, final population size at the 30‐day period or that the impact of the pharmacist intervention did not reach the threshold that this study was powered to detect. Also, a lack of statistical significance may be due to the subjective nature of ADEs/MEs and the prevention of ADEs/MEs throughout all patients' hospitalizations from the clinical pharmacist's involvement in care, which was not collected. Although a combined endpoint collecting readmission to either the ED or rehospitalization was lower in the intervention cohort, the isolated rehospitalization endpoint was not significantly different between the 2 groups. ED utilization was markedly decreased, but we may have lacked the power to show a statistically significant decrease in rehospitalization. These results mirror those of the Project RED (Re‐Engineered Discharge) intervention.[17]
HCAHPS surveys are sent to only a small percent of randomly selected patients who are discharged from the hospital. Thus, respondents may or may not have been included in the study, indicating a possible greater impact of the intervention on individual patients than collected. Importantly, the described interventions appeared to improve patients' perception of understanding the purpose of their medications. We found that HCAHPS scores across the 2 units improved, though the intervention only impacted 16.8% of all patients discharged from these units due to the nature of the survey distribution.
The pharmacists' abilities to educate all eligible patients prior to discharge from 7:30 am to 4:00 pm each day of the week was a limitation of this study, as some patients were discharged outside of the duty hours. This may have allowed for a differential exclusion and could have led to selection bias. Another limitation is that a large number of patients were lost to follow‐up in the control group, likely because the first postdischarge contact with patients was not until the day 30 phone calls. The extensive exclusion criteria caused many patients not to be enrolled. Though the intervention arm received postdischarge phone calls at days 3 and 14, only postdischarge call‐backs at day 30 of the intervention arm were compared to the control arm, which could have led to bias in the 30‐day analysis of the intervention arm, as patients may have not reported previous issues that were resolved in earlier phone calls. Medication‐related readmissions were not statistically different between the groups, which could suggest that the difference in readmissions were not solely due to the intervention, and a decrease in healthcare utilization may be due to chance. The subjective nature of how ADEs and MEs were collected also serves as a limitation, as they were only screened for presence or absence and not classified by severity or category. This study was at a single‐center academic institution, which may limit the ability to apply the results to other institutions. Last, outcome assessments relied on participant report, including ADE and ME occurrence and presentation at outside hospitals. Future study evaluation conducted as a multicenter design while continuing to strengthen the continuity of the healthcare provider and patient relationship at each intervention would be ideal. Also, having an objective measure of ADEs and MEs with severity categorization would be beneficial.
Compared to previous literature, our study design was unique in the number of phone calls made to patients postdischarge and its prospective, randomized design. In the previously mentioned study by Walker et al., phone calls were made only at days 3 and 30.[13] Although the majority of readmissions occurred within the first 14 days of discharge, additional visits to the ED and readmissions may have been avoided by contacting patients twice within the critical 14‐day period. Another distinction of this study design was the expansion of a rather limited and peripheral pharmacist role in transitions of care to a much more integrated participation. We believe the relationship developed between patients and their pharmacy care team provided coordination and the continuity of communication regarding their care. Additionally, our study was unique through the use of pharmacy extenders via fourth‐year pharmacy students who were completing their advanced pharmacy practice rotations. Pharmacy extenders can also be certified and trained pharmacy technicians, which many hospitals utilize to perform medication reconciliations at a lower cost than pharmacists. As hospitals face increased demands to shrink budgets due to decreasing reimbursements, healthcare systems will be forced to find creative new ways to use existing resources.
In conclusion, transition of care is a high‐risk situation for many patients. A comprehensive approach by healthcare providers, including pharmacists and pharmacy extenders, may have a positive impact in reducing or preventing ADEs/MEs, inpatient admissions, and ED visits. Although our study focused directly on the impact of a pharmacy care team on transitions‐of‐care, we cannot conclude this applies strictly to pharmacists. Across the nation, the role of various disciplines of healthcare providers in admission, hospitalization, discharge, and postdischarge is not standardized and varies significantly by institution. Importantly, no mechanism currently exists to directly reimburse for such efforts, but demonstration of cost effectiveness through reduced posthospital utilization may justify this investment for accountable care organizations.[18]
- , , , , , . Medicare readmission rates show meaningful decline in 2012. Medicare Medicaid Res Rev. 2013;3(2):E1‐E11.
- , , , et al. Factors contributing to all‐cause 30‐day readmissions: a structured case series across 18 hospitals. Med Care. 2012:50(7):599–605.
- , , , et al. Role of pharmacist counseling in preventing adverse events after hospitalization. Arch Intern Med. 2006;66:565–571.
- , , . Optimizing transitions of care to reduce rehospitalizations. Cleve Clin J Med. 2014;81(5):1–9.
- , , , , . The incidence and severity of adverse events affecting patients following discharge from the hospital. Ann Intern Med. 2003;138:161–167.
- , . Adverse drug events occurring following hospital discharge. J Gen Intern Med. 2005;20:317–323.
- . What do discharged patients know about their medications? Patient Educ Couns. 2005;56:276–282.
- , , , . The impact of telephone calls to patients after hospitalization. Dis Mon. 2002;48:239–248.
- , , , et al. Effect of a pharmacist intervention on clinically important medication errors after hospital discharge: a randomized trial. Ann Intern Med. 2012;157:1–10.
- , , , et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178–187.
- , , , , . The value of inpatient pharmaceutical counselling to elderly patients prior to discharge. Br J Clin Pharmacol. 2002;54:657–664.
- , , , . Postdischarge pharmacist medication reconciliation: impact on readmission rates and financial savings. J Am Pharm Assoc (2003). 2013;53(1):78–84.
- , , , et al. Impact of pharmacist‐facilitated hospital discharge program. Arch Intern Med. 2009;169:2003–2010.
- , , , et al. Does pharmacist‐led medication review help to reduce hospital admissions and deaths in older people? A systematic review and meta‐analysis. Br J Clin Pharmacol. 2008;65(3):303–316.
- . The meaning and the measure of health literacy. J Gen Intern Med. 2006;21(8):878–883.
- , , , , , . Postdischarge environmental and socioeconomic factors and the likelihood of early hospital readmission among community‐dwelling Medicare beneficiaries. Gerontologist. 2008;48(4):495–504.
- , , , , . Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011;155(2):97–107.
- , , , et al. Fostering accountable health care: moving forward in Medicare. Health Affairs. 2009;28(2):219–231.
Hospital readmissions have a significant impact on the healthcare system. Medicare data suggest a 19% all‐cause 30‐day readmission rate, of which 47% may be preventable.[1, 2] The Centers for Medicare & Medicaid Services continue to expand their criteria of disease states that will be penalized for readmissions, now reducing hospital reimbursement rates up to 3%. Pharmacists, by optimizing patient utilization of medications, can play a valuable role in contributing to preventing readmissions.[3]
Lack of acceptable transitional care is a serious problem that is consistently identified in the literature.[4] Transitional care involves 3 domains of transfer: information, education, and destination. A breakdown in any of these components can negatively impact patients and their caregivers.
Prior studies consistently demonstrated a high likelihood of adverse drug events (ADEs) and patients' lack of knowledge regarding medications postdischarge, both of which can lead to readmission. Forster and colleagues found that 19% to 23% of patients experienced an ADE within 5 weeks of discharge from an inpatient visit, 66% to 72% of which were drug related, and approximately one‐third were deemed preventable.[5, 6] One survey found that less than 60% of patients knew the indication for a new medication prescribed at discharge, whereas only 12% reported knowledge of an anticipated ADE.[7]
Pharmacists can play a large role in the information and education aspect of transitional care. Previous studies demonstrate that pharmacist involvement in the discharge process can reduce the incidence of ADEs and have a positive impact on patient satisfaction. There are conflicting data regarding the effect of comprehensive medication education and follow‐up calls by pharmacy team members on ADEs and medication errors (MEs).[3, 8, 9] Although overall pharmacist participation has shown positive patient‐related outcomes, the impact of pharmacists' involvement on readmissions has not been consistently demonstrated.[10, 11, 12, 13, 14]
Our study evaluated the impact of the pharmacy team in the transitions‐of‐care settings in a unique combination utilizing the pharmacist during medication reconciliation, discharge, and with 3 follow‐up phone call interactions postdischarge. Our study was designed to evaluate the impact of intensive pharmacist involvement during the acute care admission as well as for a 30‐day time period postdischarge on both ADEs and readmissions.
METHODS
All patients were admitted to hospitalist‐based internal medicine units at Northwestern Memorial Hospital, an 894‐bed academic medical center located in Chicago, Illinois. Patients were randomized by study investigators using a random number generator to either the usual care or intervention arms and then evaluated each day for eligibility to participate in the study. Patients remained blinded throughout the study. Patients met inclusion criteria if they were discharged to home and either discharged on greater than 3 scheduled prescription medications or discharged with at least 1 high‐risk medication. High‐risk medications were classified as anticoagulants, antiplatelets (eg, aspirin and clopidogrel), hypoglycemic agents (eg, insulin), immunosuppressants, or anti‐infectives. Patients also needed to participate in a minimum of 1 postdischarge phone call or experience an emergency department (ED) visit or readmission within 30 days of discharge to meet inclusion criteria. Exclusion criteria included: impaired cognition based on Mini‐Cog screening assessment scale, unable or unwilling to provide informed consent, lack of a personal phone number, nonEnglish speaking, subsequent elective readmission within 30 days of initial visit, more than 3 previous hospital admissions in the past 2 months, palliative care or home/skilled nursing hospice, anticipated length of survival less than 3 months, discharged within 24 hours of admission, discharged against medical advice, or discharged before medication education was conducted (Figure 1). Patients who met inclusion criteria provided informed consent, received a Mini‐Cog screening assessment, and were given the Rapid Estimate of Adult Literacy in Medicine revised (REALM‐R) assessment to evaluate health literacy. The REALM‐R is a word recognition test designed to identify patients at risk for poor health literacy skills. Patients with REALM‐R scores of 6 or less are considered to have low health literacy.[15] Patients were randomized to receive either the usual care or pharmacist‐directed medication evaluation and management as described in Table 1. Patients included in the study were contacted by phone postdischarge, with 3 attempts on consecutive days. Patients who were readmitted as an inpatient or had an ED visit were not contacted for the study after that point.
| Admission Medication Reconciliation | Hospitalist (Confirmation by Pharmacist Reviewing the History and Physical Note in Electronic Medical Record) | Performed by Pharmacy Team Member Face to Face |
|---|---|---|
| ||
| Discharge medication reconciliation | Hospitalist | Pharmacy team member |
| Discharge medication education | Hospitalist and/or nurse | Pharmacy team member |
| Individualized medication plan | No | Yes |
| Postdischarge callback day 3 | No | Yes |
| Postdischarge callback day 14 | No | Yes |
| Postdischarge callback day 30 | Yes | Yes |
| Postdischarge call assessment topic(s) | ADEs/MEs, ED visits, inpatient readmissions | ADEs/MEs, ED visits, inpatient readmissions clarify pharmacy/discharge plan, resolve medication‐related issues, identify/overcome adherence barriers |
Patients enrolled in the control group received the usual standard of care by a clinical pharmacist. This included a medication reconciliation completed from the admitting physician's patient history and physical and medication counseling provided by the physician or nursing staff at discharge. Patients were not interviewed face‐to‐face on admission and did not receive discharge counseling by a pharmacy team member. Patients were assessed daily by the pharmacist for evaluation of the pharmacotherapy plans and presence of MEs or safety‐related concerns. The control group received 1 postdischarge phone call from a pharmacist at day 30 to assess for study endpoints of ADEs, MEs, ED visit, and readmission only. The endpoints of ADEs and MEs were determined by professional judgment by the clinical pharmacist based on an algorithm similar to National Coordinating Council for Medication Error Reporting and Prevention, although a specific tool was not utilized.
The study group received face‐to‐face medication reconciliation on admission by a pharmacist or a pharmacy student. Prior to discharge, a personalized medication plan was created by the pharmacist and discussed with the physician. Medication discrepancies were addressed prior to the discharge instructions being given and discussed with the patient. Medication counseling was performed at discharge by the pharmacist or pharmacy student. Patients received 3 phone calls at 3, 14, and 30 days postdischarge. The presence of ADEs and MEs were evaluated during each phone call. The patients were asked to confirm their medication regimens including drug, indication, dose, route, and frequency. They were also asked questions regarding possible side effects, new symptoms, and any changes to their current therapy. The calls focused on clarifying the pharmacy discharge plan, resolving any unanswered questions or medication‐related issues, identifying and overcoming any barriers to adherence, and assistance with providing patients access to medications by contacting pharmacies and physicians to resolve and troubleshoot further prescription claims and clarifications. Pharmacists performed all postdischarge phone calls. Pharmacy students were able to provide face‐to‐face medication reconciliation upon admission and discharge counseling under the supervision of the pharmacist for the intervention arm.
The patient Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) responses to the medication domain question, Did you clearly understand the purpose for taking each of your medications at the time of discharge? were collected for the 2 designated hospitalist units for both the control and study groups. HCAHPS scores were collected at the 6 months point prior to the study initiation and throughout the 6‐month study period for the control and intervention groups. A physician and 2 pharmacists, who were blinded to the study randomization and results, assessed all Northwestern Memorial Hospital readmissions to determine if the readmissions were medication‐related or not.
This study obtained institutional review board approval from Northwestern University.
Data Collected
Data collected from all patients included demographics (age, sex), payer, reason for admission, number of medications at time of discharge, Charlson Comorbidity Index score, number of high‐risk medications prescribed at time of discharge, length of stay, REALM‐R score, ADEs, inpatient readmission or ED visit, and the reason for readmission or ED visit. Only the first occurrence was counted for patients with both an ED visit and an inpatient readmission. It was estimated that a sample size of 150 patients in each group would provide 80% power to demonstrate a 20% improvement in ADE rates in the study group. Data were analyzed utilizing Fischer exact, 2, and Student t tests, and multivariate logistic regression as appropriate. Analyses were performed using SAS version 9.4 (SAS Institute, Inc., Cary, NC).
RESULTS
Over the course of 7 months, 341 patients were enrolled in the study, 189 in the control arm and 152 in the study arm. Forty‐eight patients in the control group and 15 patients in the study group were lost to follow‐up. The final analysis included 278 patients, 141 in the control group and 137 in the study group. Patients were eligible for study inclusion if they received at least 1 phone call, which resulted in more patients being lost to follow‐up in the control arm due to fewer total phone call attempts. Demographic and disposition data for the control and study groups are shown in Table 2. Baseline characteristics between the 2 groups were similar with the exception of total medications at time of discharge. The control group had more total medications at discharge compared to the study group (7.2 vs 6.4, P=0.04). The number of high‐risk medications and the number of scheduled medications were similar between both groups. During medication reconciliation, 380 discrepancies (46.2%) were found in the study group compared to 205 (19.9%) in the control group (P<0.0001). The higher number of identified discrepancies in the study group was expected due to the fact that the pharmacist did not complete a face‐to‐face medication history in the control patients. The average length of stay, REALM‐R scores, and reason for admissions were similar between the 2 groups (Table 2).
| Study, N=137 | Control, N=141 | P Value | |
|---|---|---|---|
| |||
| Sex, male | 52 (37.95%) | 59 (41.8%) | 0.54 |
| Average age, y | 55.4 | 55.8 | 0.87 |
| Average length of stay, d | 5.4 (range, 1104) | 4.6 (range, 028) | 0.67 |
| Average REALM‐R score (range, 08) | 6.8 | 6.7 | 0.67 |
| Average total no. of medications | 6.4 | 7.2 | 0.04 |
| Average no. of scheduled medications | 5.7 | 6.2 | 0.15 |
| Average no. of high‐risk category medications | 2.2 | 2.3 | 0.64 |
| Reason for admission | |||
| Cardiovascular disease | 5 (3.4%) | 15 (8.3%) | 0.035 |
| Pneumonia | 11 (7.5%) | 8 (4.4%) | 0.48 |
| Respiratory | 11 (7.5%) | 9 (5%) | 0.65 |
| Infectious disease | 39 (26.5%) | 53 (29.3%) | 0.13 |
| Gastrointestinal | 25 (17%) | 28 (15.5%) | 0.13 |
| Endocrine | 20 (13.6%) | 34 (18.8%) | 0.76 |
| Genitourinary | 0 (0%) | 0 (0%) | 0.05 |
| Hematological | 19 (12.9%) | 20 (11%) | 1 |
| Injury | 10 (6.8%) | 14 (7.7%) | 1 |
| Neurological | 2 (1.4%) | 0 (0%) | 0.52 |
| Heart failure | 4 (2.7%) | 0 (0%) | 0.24 |
| Myocardial infarction | 0 (0%) | 0 (0%) | 0.58 |
| Mental/substance abuse | 1 (0.7%) | 0 (0%) | 1 |
A total of 55 patients (39%) in the control arm were readmitted to an inpatient hospital or had an ED visit within 30‐days postdischarge compared to 34 patients (24.8%) in the study group (P=0.001) (Table 3). Of the patients readmitted to the ED, 21 were enrolled in the control arm (14.8%) compared to only 6 patients in the study arm (4.4%) (P=0.005). Reviewers concluded that 24% of the control group readmissions were medication‐related versus 23% of the study group (P=1.0). In total, 78 out of 89 readmissions were to Northwestern Memorial Hospital. Medication‐related causes to outside institutions were not evaluated. The causes for all readmissions were not evaluated.
| Study Group, n=137 | Control Group, n=141 | P Value | |
|---|---|---|---|
| |||
| Composite inpatient readmission and ED visit | 34 (24.8%) | 55 (38.7%) | 0.001 |
| ED visits | 6 (4.4%) | 21 (14.8%) | 0.005 |
| Inpatient readmissions | 28 (20.4%) | 34 (23.9%) | 0.43 |
| Medication‐related readmissions | 8 (23.5%) | 13 (23.6%) | 1.0 |
| ADEs/MEs reported at 30‐day phone call | 11/84 patients | 18/86 patients | 0.22 |
| Days to readmission/ED visit | 7.9 (SD 12.5) | 13.2 (SD 9.61) | 0.03 |
| Preintervention: HCAHPS scores pertaining to knowledge of indication of medication question preintervention | 47% | ||
| Postintervention: HCAHPS scores pertaining to knowledge of indication of medication question postintervention | 56% | ||
A sensitivity analysis was undertaken to understand the impact of the lost to follow‐up rate in both the control and study groups. Undertaking an assumption that all 15 patients lost to follow‐up in the study group were readmitted and that 15 of 48 patients lost to follow‐up in the control group were readmitted, the intervention continued to show a significant benefit in reduction of composite ED and inpatient readmissions (35.7% study group vs 49.6% control group, P=0.022)
Multivariate logistic regression analysis that controlled for Charlson Comorbidity Index score, length of stay, total number of medications on discharge, and payer type showed an adjusted odds ratio of 0.55 (95% confidence interval [CI]: 0.32‐0.94) in the intervention cohort compared to controls for the combined endpoint of readmission and ED visit within 30‐days postdischarge. The adjusted odds ratio for 30‐day readmission alone was 0.88 (95% CI: 0.49‐1.61).
Eighteen of the 86 control patients who received a 30‐day postdischarge phone call experienced an ADE or ME compared to 11 of the 83 study patients (P=0.22). Patient satisfaction scores of both designated units as represented by the HCAHPS score in the medication knowledge domain increased from the prestudy period. Patients selected agree or strongly agree only 47% of the time at the 6‐month prestudy point compared to 56% of the time during the 6‐month study period.
DISCUSSION
Although previous studies show conflicting results regarding the impact of pharmacist interventions on readmissions, our study demonstrated a decrease in the composite measure of inpatient readmissions and ED visits. Its success stresses the need for a comprehensive approach that contains continuity of care by healthcare providers to reconcile and manage medications throughout the hospital stay, extending up to a full month postdischarge with multiple phone calls. This included (1) face‐to‐face medication reconciliation on admission, (2) development of a personalized medication plan discussed with the patient's physician, (3) addressing any medication discrepancies to the discharge instructions being given to the patient, (4) medication counseling performed at discharge, and (5) 3 postdischarge phone calls at 3, 14, and 30 days.
A study conducted in 2001 analyzed the Medicare Current Beneficiary Survey (MCBS) and found that living alone, having limited education, and lack of self‐management skills have significant associations with early readmission.[16] Approximately 80 million Americans have limited health literacy and are associated with poor health outcomes and healthcare utilization as seen in a review completed by Berkman and colleagues.[17] Because no difference was found between both groups, it would suggest health literacy did not influence or bias the study group. Additionally, no statistically different medication issues, such as total number of medications or rates of ADEs and MEs, were identified in the patients of this study. This may be explained by the small, final population size at the 30‐day period or that the impact of the pharmacist intervention did not reach the threshold that this study was powered to detect. Also, a lack of statistical significance may be due to the subjective nature of ADEs/MEs and the prevention of ADEs/MEs throughout all patients' hospitalizations from the clinical pharmacist's involvement in care, which was not collected. Although a combined endpoint collecting readmission to either the ED or rehospitalization was lower in the intervention cohort, the isolated rehospitalization endpoint was not significantly different between the 2 groups. ED utilization was markedly decreased, but we may have lacked the power to show a statistically significant decrease in rehospitalization. These results mirror those of the Project RED (Re‐Engineered Discharge) intervention.[17]
HCAHPS surveys are sent to only a small percent of randomly selected patients who are discharged from the hospital. Thus, respondents may or may not have been included in the study, indicating a possible greater impact of the intervention on individual patients than collected. Importantly, the described interventions appeared to improve patients' perception of understanding the purpose of their medications. We found that HCAHPS scores across the 2 units improved, though the intervention only impacted 16.8% of all patients discharged from these units due to the nature of the survey distribution.
The pharmacists' abilities to educate all eligible patients prior to discharge from 7:30 am to 4:00 pm each day of the week was a limitation of this study, as some patients were discharged outside of the duty hours. This may have allowed for a differential exclusion and could have led to selection bias. Another limitation is that a large number of patients were lost to follow‐up in the control group, likely because the first postdischarge contact with patients was not until the day 30 phone calls. The extensive exclusion criteria caused many patients not to be enrolled. Though the intervention arm received postdischarge phone calls at days 3 and 14, only postdischarge call‐backs at day 30 of the intervention arm were compared to the control arm, which could have led to bias in the 30‐day analysis of the intervention arm, as patients may have not reported previous issues that were resolved in earlier phone calls. Medication‐related readmissions were not statistically different between the groups, which could suggest that the difference in readmissions were not solely due to the intervention, and a decrease in healthcare utilization may be due to chance. The subjective nature of how ADEs and MEs were collected also serves as a limitation, as they were only screened for presence or absence and not classified by severity or category. This study was at a single‐center academic institution, which may limit the ability to apply the results to other institutions. Last, outcome assessments relied on participant report, including ADE and ME occurrence and presentation at outside hospitals. Future study evaluation conducted as a multicenter design while continuing to strengthen the continuity of the healthcare provider and patient relationship at each intervention would be ideal. Also, having an objective measure of ADEs and MEs with severity categorization would be beneficial.
Compared to previous literature, our study design was unique in the number of phone calls made to patients postdischarge and its prospective, randomized design. In the previously mentioned study by Walker et al., phone calls were made only at days 3 and 30.[13] Although the majority of readmissions occurred within the first 14 days of discharge, additional visits to the ED and readmissions may have been avoided by contacting patients twice within the critical 14‐day period. Another distinction of this study design was the expansion of a rather limited and peripheral pharmacist role in transitions of care to a much more integrated participation. We believe the relationship developed between patients and their pharmacy care team provided coordination and the continuity of communication regarding their care. Additionally, our study was unique through the use of pharmacy extenders via fourth‐year pharmacy students who were completing their advanced pharmacy practice rotations. Pharmacy extenders can also be certified and trained pharmacy technicians, which many hospitals utilize to perform medication reconciliations at a lower cost than pharmacists. As hospitals face increased demands to shrink budgets due to decreasing reimbursements, healthcare systems will be forced to find creative new ways to use existing resources.
In conclusion, transition of care is a high‐risk situation for many patients. A comprehensive approach by healthcare providers, including pharmacists and pharmacy extenders, may have a positive impact in reducing or preventing ADEs/MEs, inpatient admissions, and ED visits. Although our study focused directly on the impact of a pharmacy care team on transitions‐of‐care, we cannot conclude this applies strictly to pharmacists. Across the nation, the role of various disciplines of healthcare providers in admission, hospitalization, discharge, and postdischarge is not standardized and varies significantly by institution. Importantly, no mechanism currently exists to directly reimburse for such efforts, but demonstration of cost effectiveness through reduced posthospital utilization may justify this investment for accountable care organizations.[18]
Hospital readmissions have a significant impact on the healthcare system. Medicare data suggest a 19% all‐cause 30‐day readmission rate, of which 47% may be preventable.[1, 2] The Centers for Medicare & Medicaid Services continue to expand their criteria of disease states that will be penalized for readmissions, now reducing hospital reimbursement rates up to 3%. Pharmacists, by optimizing patient utilization of medications, can play a valuable role in contributing to preventing readmissions.[3]
Lack of acceptable transitional care is a serious problem that is consistently identified in the literature.[4] Transitional care involves 3 domains of transfer: information, education, and destination. A breakdown in any of these components can negatively impact patients and their caregivers.
Prior studies consistently demonstrated a high likelihood of adverse drug events (ADEs) and patients' lack of knowledge regarding medications postdischarge, both of which can lead to readmission. Forster and colleagues found that 19% to 23% of patients experienced an ADE within 5 weeks of discharge from an inpatient visit, 66% to 72% of which were drug related, and approximately one‐third were deemed preventable.[5, 6] One survey found that less than 60% of patients knew the indication for a new medication prescribed at discharge, whereas only 12% reported knowledge of an anticipated ADE.[7]
Pharmacists can play a large role in the information and education aspect of transitional care. Previous studies demonstrate that pharmacist involvement in the discharge process can reduce the incidence of ADEs and have a positive impact on patient satisfaction. There are conflicting data regarding the effect of comprehensive medication education and follow‐up calls by pharmacy team members on ADEs and medication errors (MEs).[3, 8, 9] Although overall pharmacist participation has shown positive patient‐related outcomes, the impact of pharmacists' involvement on readmissions has not been consistently demonstrated.[10, 11, 12, 13, 14]
Our study evaluated the impact of the pharmacy team in the transitions‐of‐care settings in a unique combination utilizing the pharmacist during medication reconciliation, discharge, and with 3 follow‐up phone call interactions postdischarge. Our study was designed to evaluate the impact of intensive pharmacist involvement during the acute care admission as well as for a 30‐day time period postdischarge on both ADEs and readmissions.
METHODS
All patients were admitted to hospitalist‐based internal medicine units at Northwestern Memorial Hospital, an 894‐bed academic medical center located in Chicago, Illinois. Patients were randomized by study investigators using a random number generator to either the usual care or intervention arms and then evaluated each day for eligibility to participate in the study. Patients remained blinded throughout the study. Patients met inclusion criteria if they were discharged to home and either discharged on greater than 3 scheduled prescription medications or discharged with at least 1 high‐risk medication. High‐risk medications were classified as anticoagulants, antiplatelets (eg, aspirin and clopidogrel), hypoglycemic agents (eg, insulin), immunosuppressants, or anti‐infectives. Patients also needed to participate in a minimum of 1 postdischarge phone call or experience an emergency department (ED) visit or readmission within 30 days of discharge to meet inclusion criteria. Exclusion criteria included: impaired cognition based on Mini‐Cog screening assessment scale, unable or unwilling to provide informed consent, lack of a personal phone number, nonEnglish speaking, subsequent elective readmission within 30 days of initial visit, more than 3 previous hospital admissions in the past 2 months, palliative care or home/skilled nursing hospice, anticipated length of survival less than 3 months, discharged within 24 hours of admission, discharged against medical advice, or discharged before medication education was conducted (Figure 1). Patients who met inclusion criteria provided informed consent, received a Mini‐Cog screening assessment, and were given the Rapid Estimate of Adult Literacy in Medicine revised (REALM‐R) assessment to evaluate health literacy. The REALM‐R is a word recognition test designed to identify patients at risk for poor health literacy skills. Patients with REALM‐R scores of 6 or less are considered to have low health literacy.[15] Patients were randomized to receive either the usual care or pharmacist‐directed medication evaluation and management as described in Table 1. Patients included in the study were contacted by phone postdischarge, with 3 attempts on consecutive days. Patients who were readmitted as an inpatient or had an ED visit were not contacted for the study after that point.
| Admission Medication Reconciliation | Hospitalist (Confirmation by Pharmacist Reviewing the History and Physical Note in Electronic Medical Record) | Performed by Pharmacy Team Member Face to Face |
|---|---|---|
| ||
| Discharge medication reconciliation | Hospitalist | Pharmacy team member |
| Discharge medication education | Hospitalist and/or nurse | Pharmacy team member |
| Individualized medication plan | No | Yes |
| Postdischarge callback day 3 | No | Yes |
| Postdischarge callback day 14 | No | Yes |
| Postdischarge callback day 30 | Yes | Yes |
| Postdischarge call assessment topic(s) | ADEs/MEs, ED visits, inpatient readmissions | ADEs/MEs, ED visits, inpatient readmissions clarify pharmacy/discharge plan, resolve medication‐related issues, identify/overcome adherence barriers |
Patients enrolled in the control group received the usual standard of care by a clinical pharmacist. This included a medication reconciliation completed from the admitting physician's patient history and physical and medication counseling provided by the physician or nursing staff at discharge. Patients were not interviewed face‐to‐face on admission and did not receive discharge counseling by a pharmacy team member. Patients were assessed daily by the pharmacist for evaluation of the pharmacotherapy plans and presence of MEs or safety‐related concerns. The control group received 1 postdischarge phone call from a pharmacist at day 30 to assess for study endpoints of ADEs, MEs, ED visit, and readmission only. The endpoints of ADEs and MEs were determined by professional judgment by the clinical pharmacist based on an algorithm similar to National Coordinating Council for Medication Error Reporting and Prevention, although a specific tool was not utilized.
The study group received face‐to‐face medication reconciliation on admission by a pharmacist or a pharmacy student. Prior to discharge, a personalized medication plan was created by the pharmacist and discussed with the physician. Medication discrepancies were addressed prior to the discharge instructions being given and discussed with the patient. Medication counseling was performed at discharge by the pharmacist or pharmacy student. Patients received 3 phone calls at 3, 14, and 30 days postdischarge. The presence of ADEs and MEs were evaluated during each phone call. The patients were asked to confirm their medication regimens including drug, indication, dose, route, and frequency. They were also asked questions regarding possible side effects, new symptoms, and any changes to their current therapy. The calls focused on clarifying the pharmacy discharge plan, resolving any unanswered questions or medication‐related issues, identifying and overcoming any barriers to adherence, and assistance with providing patients access to medications by contacting pharmacies and physicians to resolve and troubleshoot further prescription claims and clarifications. Pharmacists performed all postdischarge phone calls. Pharmacy students were able to provide face‐to‐face medication reconciliation upon admission and discharge counseling under the supervision of the pharmacist for the intervention arm.
The patient Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) responses to the medication domain question, Did you clearly understand the purpose for taking each of your medications at the time of discharge? were collected for the 2 designated hospitalist units for both the control and study groups. HCAHPS scores were collected at the 6 months point prior to the study initiation and throughout the 6‐month study period for the control and intervention groups. A physician and 2 pharmacists, who were blinded to the study randomization and results, assessed all Northwestern Memorial Hospital readmissions to determine if the readmissions were medication‐related or not.
This study obtained institutional review board approval from Northwestern University.
Data Collected
Data collected from all patients included demographics (age, sex), payer, reason for admission, number of medications at time of discharge, Charlson Comorbidity Index score, number of high‐risk medications prescribed at time of discharge, length of stay, REALM‐R score, ADEs, inpatient readmission or ED visit, and the reason for readmission or ED visit. Only the first occurrence was counted for patients with both an ED visit and an inpatient readmission. It was estimated that a sample size of 150 patients in each group would provide 80% power to demonstrate a 20% improvement in ADE rates in the study group. Data were analyzed utilizing Fischer exact, 2, and Student t tests, and multivariate logistic regression as appropriate. Analyses were performed using SAS version 9.4 (SAS Institute, Inc., Cary, NC).
RESULTS
Over the course of 7 months, 341 patients were enrolled in the study, 189 in the control arm and 152 in the study arm. Forty‐eight patients in the control group and 15 patients in the study group were lost to follow‐up. The final analysis included 278 patients, 141 in the control group and 137 in the study group. Patients were eligible for study inclusion if they received at least 1 phone call, which resulted in more patients being lost to follow‐up in the control arm due to fewer total phone call attempts. Demographic and disposition data for the control and study groups are shown in Table 2. Baseline characteristics between the 2 groups were similar with the exception of total medications at time of discharge. The control group had more total medications at discharge compared to the study group (7.2 vs 6.4, P=0.04). The number of high‐risk medications and the number of scheduled medications were similar between both groups. During medication reconciliation, 380 discrepancies (46.2%) were found in the study group compared to 205 (19.9%) in the control group (P<0.0001). The higher number of identified discrepancies in the study group was expected due to the fact that the pharmacist did not complete a face‐to‐face medication history in the control patients. The average length of stay, REALM‐R scores, and reason for admissions were similar between the 2 groups (Table 2).
| Study, N=137 | Control, N=141 | P Value | |
|---|---|---|---|
| |||
| Sex, male | 52 (37.95%) | 59 (41.8%) | 0.54 |
| Average age, y | 55.4 | 55.8 | 0.87 |
| Average length of stay, d | 5.4 (range, 1104) | 4.6 (range, 028) | 0.67 |
| Average REALM‐R score (range, 08) | 6.8 | 6.7 | 0.67 |
| Average total no. of medications | 6.4 | 7.2 | 0.04 |
| Average no. of scheduled medications | 5.7 | 6.2 | 0.15 |
| Average no. of high‐risk category medications | 2.2 | 2.3 | 0.64 |
| Reason for admission | |||
| Cardiovascular disease | 5 (3.4%) | 15 (8.3%) | 0.035 |
| Pneumonia | 11 (7.5%) | 8 (4.4%) | 0.48 |
| Respiratory | 11 (7.5%) | 9 (5%) | 0.65 |
| Infectious disease | 39 (26.5%) | 53 (29.3%) | 0.13 |
| Gastrointestinal | 25 (17%) | 28 (15.5%) | 0.13 |
| Endocrine | 20 (13.6%) | 34 (18.8%) | 0.76 |
| Genitourinary | 0 (0%) | 0 (0%) | 0.05 |
| Hematological | 19 (12.9%) | 20 (11%) | 1 |
| Injury | 10 (6.8%) | 14 (7.7%) | 1 |
| Neurological | 2 (1.4%) | 0 (0%) | 0.52 |
| Heart failure | 4 (2.7%) | 0 (0%) | 0.24 |
| Myocardial infarction | 0 (0%) | 0 (0%) | 0.58 |
| Mental/substance abuse | 1 (0.7%) | 0 (0%) | 1 |
A total of 55 patients (39%) in the control arm were readmitted to an inpatient hospital or had an ED visit within 30‐days postdischarge compared to 34 patients (24.8%) in the study group (P=0.001) (Table 3). Of the patients readmitted to the ED, 21 were enrolled in the control arm (14.8%) compared to only 6 patients in the study arm (4.4%) (P=0.005). Reviewers concluded that 24% of the control group readmissions were medication‐related versus 23% of the study group (P=1.0). In total, 78 out of 89 readmissions were to Northwestern Memorial Hospital. Medication‐related causes to outside institutions were not evaluated. The causes for all readmissions were not evaluated.
| Study Group, n=137 | Control Group, n=141 | P Value | |
|---|---|---|---|
| |||
| Composite inpatient readmission and ED visit | 34 (24.8%) | 55 (38.7%) | 0.001 |
| ED visits | 6 (4.4%) | 21 (14.8%) | 0.005 |
| Inpatient readmissions | 28 (20.4%) | 34 (23.9%) | 0.43 |
| Medication‐related readmissions | 8 (23.5%) | 13 (23.6%) | 1.0 |
| ADEs/MEs reported at 30‐day phone call | 11/84 patients | 18/86 patients | 0.22 |
| Days to readmission/ED visit | 7.9 (SD 12.5) | 13.2 (SD 9.61) | 0.03 |
| Preintervention: HCAHPS scores pertaining to knowledge of indication of medication question preintervention | 47% | ||
| Postintervention: HCAHPS scores pertaining to knowledge of indication of medication question postintervention | 56% | ||
A sensitivity analysis was undertaken to understand the impact of the lost to follow‐up rate in both the control and study groups. Undertaking an assumption that all 15 patients lost to follow‐up in the study group were readmitted and that 15 of 48 patients lost to follow‐up in the control group were readmitted, the intervention continued to show a significant benefit in reduction of composite ED and inpatient readmissions (35.7% study group vs 49.6% control group, P=0.022)
Multivariate logistic regression analysis that controlled for Charlson Comorbidity Index score, length of stay, total number of medications on discharge, and payer type showed an adjusted odds ratio of 0.55 (95% confidence interval [CI]: 0.32‐0.94) in the intervention cohort compared to controls for the combined endpoint of readmission and ED visit within 30‐days postdischarge. The adjusted odds ratio for 30‐day readmission alone was 0.88 (95% CI: 0.49‐1.61).
Eighteen of the 86 control patients who received a 30‐day postdischarge phone call experienced an ADE or ME compared to 11 of the 83 study patients (P=0.22). Patient satisfaction scores of both designated units as represented by the HCAHPS score in the medication knowledge domain increased from the prestudy period. Patients selected agree or strongly agree only 47% of the time at the 6‐month prestudy point compared to 56% of the time during the 6‐month study period.
DISCUSSION
Although previous studies show conflicting results regarding the impact of pharmacist interventions on readmissions, our study demonstrated a decrease in the composite measure of inpatient readmissions and ED visits. Its success stresses the need for a comprehensive approach that contains continuity of care by healthcare providers to reconcile and manage medications throughout the hospital stay, extending up to a full month postdischarge with multiple phone calls. This included (1) face‐to‐face medication reconciliation on admission, (2) development of a personalized medication plan discussed with the patient's physician, (3) addressing any medication discrepancies to the discharge instructions being given to the patient, (4) medication counseling performed at discharge, and (5) 3 postdischarge phone calls at 3, 14, and 30 days.
A study conducted in 2001 analyzed the Medicare Current Beneficiary Survey (MCBS) and found that living alone, having limited education, and lack of self‐management skills have significant associations with early readmission.[16] Approximately 80 million Americans have limited health literacy and are associated with poor health outcomes and healthcare utilization as seen in a review completed by Berkman and colleagues.[17] Because no difference was found between both groups, it would suggest health literacy did not influence or bias the study group. Additionally, no statistically different medication issues, such as total number of medications or rates of ADEs and MEs, were identified in the patients of this study. This may be explained by the small, final population size at the 30‐day period or that the impact of the pharmacist intervention did not reach the threshold that this study was powered to detect. Also, a lack of statistical significance may be due to the subjective nature of ADEs/MEs and the prevention of ADEs/MEs throughout all patients' hospitalizations from the clinical pharmacist's involvement in care, which was not collected. Although a combined endpoint collecting readmission to either the ED or rehospitalization was lower in the intervention cohort, the isolated rehospitalization endpoint was not significantly different between the 2 groups. ED utilization was markedly decreased, but we may have lacked the power to show a statistically significant decrease in rehospitalization. These results mirror those of the Project RED (Re‐Engineered Discharge) intervention.[17]
HCAHPS surveys are sent to only a small percent of randomly selected patients who are discharged from the hospital. Thus, respondents may or may not have been included in the study, indicating a possible greater impact of the intervention on individual patients than collected. Importantly, the described interventions appeared to improve patients' perception of understanding the purpose of their medications. We found that HCAHPS scores across the 2 units improved, though the intervention only impacted 16.8% of all patients discharged from these units due to the nature of the survey distribution.
The pharmacists' abilities to educate all eligible patients prior to discharge from 7:30 am to 4:00 pm each day of the week was a limitation of this study, as some patients were discharged outside of the duty hours. This may have allowed for a differential exclusion and could have led to selection bias. Another limitation is that a large number of patients were lost to follow‐up in the control group, likely because the first postdischarge contact with patients was not until the day 30 phone calls. The extensive exclusion criteria caused many patients not to be enrolled. Though the intervention arm received postdischarge phone calls at days 3 and 14, only postdischarge call‐backs at day 30 of the intervention arm were compared to the control arm, which could have led to bias in the 30‐day analysis of the intervention arm, as patients may have not reported previous issues that were resolved in earlier phone calls. Medication‐related readmissions were not statistically different between the groups, which could suggest that the difference in readmissions were not solely due to the intervention, and a decrease in healthcare utilization may be due to chance. The subjective nature of how ADEs and MEs were collected also serves as a limitation, as they were only screened for presence or absence and not classified by severity or category. This study was at a single‐center academic institution, which may limit the ability to apply the results to other institutions. Last, outcome assessments relied on participant report, including ADE and ME occurrence and presentation at outside hospitals. Future study evaluation conducted as a multicenter design while continuing to strengthen the continuity of the healthcare provider and patient relationship at each intervention would be ideal. Also, having an objective measure of ADEs and MEs with severity categorization would be beneficial.
Compared to previous literature, our study design was unique in the number of phone calls made to patients postdischarge and its prospective, randomized design. In the previously mentioned study by Walker et al., phone calls were made only at days 3 and 30.[13] Although the majority of readmissions occurred within the first 14 days of discharge, additional visits to the ED and readmissions may have been avoided by contacting patients twice within the critical 14‐day period. Another distinction of this study design was the expansion of a rather limited and peripheral pharmacist role in transitions of care to a much more integrated participation. We believe the relationship developed between patients and their pharmacy care team provided coordination and the continuity of communication regarding their care. Additionally, our study was unique through the use of pharmacy extenders via fourth‐year pharmacy students who were completing their advanced pharmacy practice rotations. Pharmacy extenders can also be certified and trained pharmacy technicians, which many hospitals utilize to perform medication reconciliations at a lower cost than pharmacists. As hospitals face increased demands to shrink budgets due to decreasing reimbursements, healthcare systems will be forced to find creative new ways to use existing resources.
In conclusion, transition of care is a high‐risk situation for many patients. A comprehensive approach by healthcare providers, including pharmacists and pharmacy extenders, may have a positive impact in reducing or preventing ADEs/MEs, inpatient admissions, and ED visits. Although our study focused directly on the impact of a pharmacy care team on transitions‐of‐care, we cannot conclude this applies strictly to pharmacists. Across the nation, the role of various disciplines of healthcare providers in admission, hospitalization, discharge, and postdischarge is not standardized and varies significantly by institution. Importantly, no mechanism currently exists to directly reimburse for such efforts, but demonstration of cost effectiveness through reduced posthospital utilization may justify this investment for accountable care organizations.[18]
- , , , , , . Medicare readmission rates show meaningful decline in 2012. Medicare Medicaid Res Rev. 2013;3(2):E1‐E11.
- , , , et al. Factors contributing to all‐cause 30‐day readmissions: a structured case series across 18 hospitals. Med Care. 2012:50(7):599–605.
- , , , et al. Role of pharmacist counseling in preventing adverse events after hospitalization. Arch Intern Med. 2006;66:565–571.
- , , . Optimizing transitions of care to reduce rehospitalizations. Cleve Clin J Med. 2014;81(5):1–9.
- , , , , . The incidence and severity of adverse events affecting patients following discharge from the hospital. Ann Intern Med. 2003;138:161–167.
- , . Adverse drug events occurring following hospital discharge. J Gen Intern Med. 2005;20:317–323.
- . What do discharged patients know about their medications? Patient Educ Couns. 2005;56:276–282.
- , , , . The impact of telephone calls to patients after hospitalization. Dis Mon. 2002;48:239–248.
- , , , et al. Effect of a pharmacist intervention on clinically important medication errors after hospital discharge: a randomized trial. Ann Intern Med. 2012;157:1–10.
- , , , et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178–187.
- , , , , . The value of inpatient pharmaceutical counselling to elderly patients prior to discharge. Br J Clin Pharmacol. 2002;54:657–664.
- , , , . Postdischarge pharmacist medication reconciliation: impact on readmission rates and financial savings. J Am Pharm Assoc (2003). 2013;53(1):78–84.
- , , , et al. Impact of pharmacist‐facilitated hospital discharge program. Arch Intern Med. 2009;169:2003–2010.
- , , , et al. Does pharmacist‐led medication review help to reduce hospital admissions and deaths in older people? A systematic review and meta‐analysis. Br J Clin Pharmacol. 2008;65(3):303–316.
- . The meaning and the measure of health literacy. J Gen Intern Med. 2006;21(8):878–883.
- , , , , , . Postdischarge environmental and socioeconomic factors and the likelihood of early hospital readmission among community‐dwelling Medicare beneficiaries. Gerontologist. 2008;48(4):495–504.
- , , , , . Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011;155(2):97–107.
- , , , et al. Fostering accountable health care: moving forward in Medicare. Health Affairs. 2009;28(2):219–231.
- , , , , , . Medicare readmission rates show meaningful decline in 2012. Medicare Medicaid Res Rev. 2013;3(2):E1‐E11.
- , , , et al. Factors contributing to all‐cause 30‐day readmissions: a structured case series across 18 hospitals. Med Care. 2012:50(7):599–605.
- , , , et al. Role of pharmacist counseling in preventing adverse events after hospitalization. Arch Intern Med. 2006;66:565–571.
- , , . Optimizing transitions of care to reduce rehospitalizations. Cleve Clin J Med. 2014;81(5):1–9.
- , , , , . The incidence and severity of adverse events affecting patients following discharge from the hospital. Ann Intern Med. 2003;138:161–167.
- , . Adverse drug events occurring following hospital discharge. J Gen Intern Med. 2005;20:317–323.
- . What do discharged patients know about their medications? Patient Educ Couns. 2005;56:276–282.
- , , , . The impact of telephone calls to patients after hospitalization. Dis Mon. 2002;48:239–248.
- , , , et al. Effect of a pharmacist intervention on clinically important medication errors after hospital discharge: a randomized trial. Ann Intern Med. 2012;157:1–10.
- , , , et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178–187.
- , , , , . The value of inpatient pharmaceutical counselling to elderly patients prior to discharge. Br J Clin Pharmacol. 2002;54:657–664.
- , , , . Postdischarge pharmacist medication reconciliation: impact on readmission rates and financial savings. J Am Pharm Assoc (2003). 2013;53(1):78–84.
- , , , et al. Impact of pharmacist‐facilitated hospital discharge program. Arch Intern Med. 2009;169:2003–2010.
- , , , et al. Does pharmacist‐led medication review help to reduce hospital admissions and deaths in older people? A systematic review and meta‐analysis. Br J Clin Pharmacol. 2008;65(3):303–316.
- . The meaning and the measure of health literacy. J Gen Intern Med. 2006;21(8):878–883.
- , , , , , . Postdischarge environmental and socioeconomic factors and the likelihood of early hospital readmission among community‐dwelling Medicare beneficiaries. Gerontologist. 2008;48(4):495–504.
- , , , , . Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011;155(2):97–107.
- , , , et al. Fostering accountable health care: moving forward in Medicare. Health Affairs. 2009;28(2):219–231.
© 2015 Society of Hospital Medicine
Hand Hygiene Intervention in Japan
Healthcare‐associated infections are a major cause of illness and death in hospitalized patients, and preventing healthcare‐associated infection is a global challenge.[1] Worldwide, the prevalence of healthcare‐associated infections in developed and undeveloped countries ranges from 5.1% to 11.6% and 5.7% to 19.1%, respectively.[2] In the United States, roughly 2 million such infections occur annually, resulting in approximately 99,000 deaths[3] and estimated annual direct medical costs between $28.4 and $33.8 billion.[4] In Japan, nearly 9% of patients admitted to the intensive care unit (ICU) develop an infection during hospitalization,[5] and 5% of all patients hospitalized become infected with methicillin‐resistant Staphylococcus aureus.[6] The management of healthcare‐associated infections in Japan accounts for up to 5% of total annual healthcare costs, with an estimated $6.8 billion estimated to be potentially preventable.[7] In addition, healthcare‐associated infections are associated with increased length of stay in the hospital. Studies estimate surgical site infections extend length of stay by 9.7 days,[8] and bloodstream infections increase length of stay by 10 days.[9]
Improving hand hygiene practice for healthcare workers is considered a core strategy to decrease the incidence of healthcare‐associated infection.[6, 10] Specifically, the use of alcohol‐based hand rub is strongly recommended in acute care hospitals by both the World Health Organization (WHO) and the US Centers for Disease Control and Prevention.[11, 12] Improving hand hygiene adherence may reduce healthcare‐associated infection by 9% to 50%,[13, 14] and multiple studies have reported that greater use of alcohol‐based hand rubs results in significant reductions in healthcare‐associated infections.[14, 15]
Due to the difficulty in improving hand hygiene in various settings across the world, the WHO strategy for improving hand hygiene has been adopted and implemented by several studies in varying locations, such as Costa Rica, Italy, Mali, Pakistan, and Saudi Arabia.[16] Implementations of these multimodal strategies, following WHObased guidelines, have been shown to increase the level of hand hygiene adherence among healthcare workers and reduce infections at these locations.[14, 17, 18] This study expands upon that work by extending the same implementation strategy to assess the effectiveness of the introduction of alcohol‐based hand rub on hand hygiene practice at multiple hospitals in Japan.
In a previous article[19] we reported results from an observational study assessing healthcare worker hand hygiene adherence before touching the patient in 4 geographically diverse hospitals in Japan. The study reported that hand hygiene adherence in Japanese hospitals was lower than reported mean values from other international studies, and that greater adherence to hand hygiene should be encouraged. In this article, we present the results of a multimodal intervention intended to improve levels of healthcare worker hand hygiene in 3 of these hospitals.
METHODS
Participating Institutions
Three of the 4 hospitals participating in the prior observational study chose to participate in this intervention. Evaluation of hand hygiene practice was performed in at least 3 wards of each hospital including an inpatient surgical ward, an inpatient medicine ward, an ICU, or an emergency ward.
Table 1 lists the characteristics of the participating hospitals. Hospital A is a university‐affiliated, tertiary care medical center with 312 beds in East Japan. Although the hospital did not have an infection prevention unit or designated infection control nurses during the preintervention periods, the hospital hired a designated infection prevention nurse and established a department of infection prevention before this intervention in April 2012. Hospital B is a community‐based, tertiary care medical center with 428 beds, located in Midwest Japan. Although the facility had no infection control nurses at the outset of the study, a physician certified by the American Board of Internal Medicine and Infectious Diseases provided educational sessions of hand hygiene. Hospital B hired a designated infection prevention nurse and established a department of infection prevention in April 2012. Hospital C, located in Northern Japan, is a community‐based, tertiary care medical center with 562 beds. The department of infection prevention was established in 2010 and has 1 full‐time and 2 part‐time infection prevention nurses.
| Hospital A | Hospital B | Hospital C | ||||
|---|---|---|---|---|---|---|
| Preintervention | Postintervention | Preintervention | Postintervention | Preintervention | Postintervention | |
| ||||||
| Hospital characteristics | ||||||
| Location | East Japan | Midwest Japan | Northern Japan | |||
| Hospital type | University affiliated | Community based | Community based | |||
| Level of care | Tertiary care | Tertiary care | Tertiary care | |||
| Residency program | Yes | Yes | Yes | |||
| No. of beds | 250 | 312 | 428 | 428 | 550 | 562 |
| No. of employees | 398 | 475 | 1,035 | 1,263 | 1,500 | 1,568 |
| No. of physicians | 73 | 91 | 179 | 188 | 207 | 217 |
| No. of nurses | 172 | 210 | 410 | 540 | 616 | 800 |
| Infection control practice | ||||||
| Establishment of infection prevention units (year) | N/A | Yes (2012) | N/A | Yes (2012) | Yes (2010) | Yes |
| Employment of certified nurses in infection control (FTE) | 0 | 1 (1) | 0 | 1 (1) | 3 (1.5) | 3 (1.5) |
| Employment of ABIM‐IDcertified physician | 0 | 0 | 1 | 1 | 1 | 0 |
Role of the Funding Source
This study was unfunded. The prize for the contest was provided by an American collaborator (S.S.) who was not affiliated with any of the participating hospitals.
Intervention
In the prior preintervention study, hand hygiene adherence rates of healthcare workers were evaluated between July 2011 and November 2011.[19] To improve hand hygiene adherence in these facilities, we initiated a multimodal intervention based on WHO recommendations and the findings from the prior study. Each facility was provided the same guidance on how to improve hand hygiene adherence (Table 2) and encouraged to tailor the intervention to their local setting. As an added incentive, we initiated a contest, where the facility obtaining the highest hand hygiene adherence postintervention would win a trophy and 500,000 Japanese yen (approximately $5000 US dollars). The recommended strategies consisted of 15 components (Table 2): infrastructure (3 components), training and education (2 components), evaluation and feedback (5 components), reminder in the workplace (1 component), and institution safety climate (4 components). Of note, the participating institutions had already implemented a varying number of the intervention components prior to the start of the intervention. Each facility conducted a 6‐month intervention to improve hand hygiene adherence; however, the actual timing of interventions varied slightly by institution. Hospitals A and C conducted an intervention from October 2012 through March 2013, whereas hospital B's intervention was from April 2012 to September 2012. Details of the multimodal intervention performed at each participating hospital are shown in Table 3.
| Intervention Components | Description |
|---|---|
| 1. Infrastructure (3 components) | |
| Hand‐washing faucets for each room | At least 1 faucet and sink for each room was available. |
| Placement of alcohol hand rub at patient's room entrance | Alcohol hand rub was placed at all patient room entrances. |
| Portable alcohol hand rub distributed for each healthcare worker | Personal, portable alcohol hand rub dispensers were provided for healthcare workers who contact patients. |
| 2. Training/education (2 components) | |
| Educational resources | At least 1 physician or 1 nurse who provides educational sessions regarding hand hygiene practice was available. |
| Periodic seminars and lectures regarding hand hygiene education | Hospital‐wide hand hygiene seminar or educational activities were held during the intervention period. |
| 3. Evaluation and feedback (5 components) | |
| Evaluation of hand hygiene practice by direct observation | Hospitals utilize direct observation for healthcare worker's hand hygiene practice. |
| Evaluation of hand hygiene practice by monitoring the amount of alcohol hand rub consumption | Hospitals utilize the amount of alcohol hand rub consumption as a parameter for healthcare worker's hand hygiene practice. |
| Hand hygiene rate feedback at infection control committee | Hand hygiene adherence rate was reported and discussed at hospital infection control committee. |
| Hand hygiene rate feedback to the designated wards/units | Hand hygiene adherence rate was reported and discussed with healthcare workers at the designated wards/units where hand hygiene observation was performed. |
| Granting the award of top‐rated person of hand hygiene | Hospitals established the system to assess individual healthcare worker's hand hygiene adherence rate. |
| 4. Reminder in the workplace (1 components) | |
| Poster notification | Poster notification for hand hygiene practice was performed in the intervention period. |
| 5. Institutional safety climate (4 components) | |
| Commitment of hospital president or hospital executives | Hospital executives including the president agreed on the importance of hand hygiene practice and declared to healthcare workers to enhance hand hygiene practice during the intervention period. |
| Commitment of nurse managers and physician leaders | Commitment of improving hand hygiene practice by representative healthcare workers at the designated wards/units (eg, meeting by nurse manager or physician leaders at the designated wards/units and collaborative work with infection prevention services). |
| Meeting at the designated wards/units | A ward/unit‐level meeting or voluntary session for hands‐on hand hygiene practice by healthcare workers at the designated wards/units. |
| Identifying champions at the designated wards/units | An individual healthcare worker who contributed to improving hand hygiene practice was appointed. |
| Hospital A | Hospital Ba | Hospital C | ||||
|---|---|---|---|---|---|---|
| ||||||
| Intervention period | October 2012March 2013 | April 2012September 2012 | October 2012March 2013 | |||
| Evaluation of hand hygiene in the postintervention period | May 2013July 2013 | October 2012 | June 2013 | |||
| Suggested intervention components | Preintervention | Postintervention | Preintervention | Postintervention | Preintervention | Postintervention |
| No. of implemented components | 2/15 | 10/15 | 9/15 | 10/15 | 6/15 | 8/15 |
| Infrastructure (3 components) | ||||||
| Hand‐washing faucets for each room | No | No | Yes | Yes | Yes | Yes |
| Placement of alcohol hand rubs at patient's room entrance | Yes | Yes | Yes | Yes | Yes | Yes |
| Portable alcohol hand rub distributed for each healthcare worker | No | Yesb | No | Yesb | No | No |
| Training/education (2 components) | ||||||
| Educational resources | No | Yesb | Yes | Yesb | Yes | Yes |
| Periodic seminars and lectures regarding hand hygiene education | No | Yesb | Yes | Yes | Yes | Yes |
| Evaluation and feedback (5 components) | ||||||
| Evaluation of hand hygiene practice by direct observation | No | Yesb | Yes | Yes | No | No |
| Evaluation of hand hygiene practice by the amount of alcohol hand rub consumption | No | No | Yes | Yes | Yes | Yes |
| Hand hygiene rate feedback at infection control committee | No | Yesb | Yes | Yes | No | Yesb |
| Hand hygiene rate feedback to designated departments | No | Yesb | Yes | Yes | No | Yesb |
| Granting the award of top‐rated person | No | No | No | No | No | No |
| Reminders in the workplace (1 component) | ||||||
| Poster notification | Yes | Yes | Yes | Yes | Yes | Yes |
| 5. Institutional safety climate (4 components) | ||||||
| Commitment of hospital president or hospital executives | No | Yesb | No | No | No | No |
| Commitment of nurse managers and physicians leaders | No | Yesb | No | No | No | No |
| Meeting regarding hand hygiene practice by the designated wards/units | No | No | No | No | No | No |
| Identifying champions at the designated wards/units | No | No | No | No | No | No |
Observation of Hand Hygiene Practice
The same methods for hand hygiene observation used for the preintervention study was used for postintervention assessment. Ten distinct units across the 3 participating hospitals were evaluated for healthcare worker hand hygiene prior to patient contact. Three to 4 units were observed at each facility. One of the study authors (T.S.), a Japanese board‐certified infection control nurse, conducted all of the hand hygiene observations for both the preintervention and postintervention studies. Intraobserver variation was minimized by providing the same training outlined in the previous study.[19] Appropriate hand hygiene was defined as the use of soap and water or alcohol‐based hand rub before patient contact, which corresponds to the first moment of the WHO's 5 moments of hand hygiene.[11]
Hand hygiene practice prior to patient contact for each individual provider‐patient encounter was observed and recorded using the hand hygiene observation form adapted from a previous study by Saint et al.[6, 20] Identical to the preintervention study,[19] the form captured the following information: unit in which observations were performed, time of initiation and completion of observations, healthcare worker subgroup (physician or nurse), and the type of hand hygiene before patient contact (ie, hand washing with soap and water, use of alcohol‐based hand rub, or no hand hygiene). Unit physicians and nurses were informed that their clinical practices were going to be observed, but were not informed of the purpose of the observations (eg, hand hygiene adherence). To avoid interfering with clinical care delivery, the observer was given strict instructions to maintain a certain distance from the observed healthcare workers. The observer was instructed to leave immediately if asked for any reason by the unit staff or patients.
Statistical Analysis
Overall hand hygiene adherence rates were calculated and compared between the pre‐ and the postintervention periods. Comparison of hand hygiene adherence by healthcare worker subgroup and by hospital unit between the pre‐ and postintervention periods was also performed. Hand hygiene adherence rates were compared using JMP 9.0 and SAS 9.3 (SAS Institute Inc., Cary, NC). Comparison of hand hygiene adherence rates by observational periods was calculated by Pearson [2] tests, and 95% confidence intervals (CIs) were estimated using binomial distribution. Pearson correlations were used to determine the relationship of hand hygiene between physicians and nurses in the same unit. Two‐tailed P value0.05 was considered statistically significant. The study protocol was reviewed and approved by the ethics committees at the participating hospitals.
RESULTS
Data were collected from May 2013 to July 2013 in hospital A, in October 2012 in hospital B, and June 2013 in hospital C to ensure data were collected after the 6‐month intervention at each site. A total of 2982 observations of hand hygiene were performed in 10 distinct units across the 3 participating hospitals during the postintervention periods. Hand hygiene observations were performed during the day Monday through Friday between 8:30 am and 7:30 pm, with the majority occurring prior to 1:00 pm.
The overall postintervention hand hygiene adherence rate (in all 3 hospitals) was significantly higher at 32.7% (974/2982) adherence compared to 18.0% (482/2679) adherence in the preintervention period (P<0.001). An increased hand hygiene adherence rate in each participating hospital in the postintervention period was observed (Figure 1). Similar trends of higher overall hand hygiene adherence rates for both nurses and physicians in the postintervention period were seen. Use of alcohol‐based hand rub among those with appropriate hand hygiene was significantly higher, with 90.0% (880/974) using hand rub in the postintervention period versus 67.0% (322/482) in the preintervention period (P<0.001). Comparison of overall hand hygiene adherence rates by unit type and healthcare worker subgroup between the pre‐ and postintervention periods are shown in Table 4. Detailed comparisons of hand hygiene adherence rates for each hospital are available in the supplementary appendix. Although a significant improvement of hand hygiene practice was observed in the majority of participating units (6/10), there was a significant decline in hand hygiene practice in 2 units for nurses and 1 unit for physicians. Hand hygiene adherence rates by healthcare worker subgroups (both physicians and nurses) were significantly higher in the postintervention period than those in the preintervention period. Trends toward higher hand hygiene adherence rate of nurses in the postintervention period were observed (34.8% adherence for nurses compared to 30.4% adherence for physicians); the difference between nurses and physicians were not statistically significant (P=0.07).
| Ward/Unit | Healthcare Worker Subgroup | Preintervention Period | Postintervention Period | Improvement After Intervention (%) | P Value | ||
|---|---|---|---|---|---|---|---|
| No. of Observations | Hand hygiene Adherence (%) | No. of Observations | Hand Hygiene Adherence (%) | ||||
| |||||||
| All 3 hospitals | |||||||
| Surgery | Nurse | 455 | 20 | 480 | 40 | 20 | <0.001 |
| Physician | 424 | 18 | 448 | 43 | 25 | <0.001 | |
| All | 879 | 19 | 928 | 41 | 22 | <0.001 | |
| Medicine | Nurse | 455 | 23 | 508 | 39 | 16 | <0.001 |
| Physician | 435 | 15 | 452 | 33 | 18 | <0.001 | |
| All | 890 | 20 | 960 | 36 | 16 | <0.001 | |
| ICU | Nurse | 305 | 21 | 379 | 25 | 4 | 0.17 |
| Physician | 203 | 9 | 268 | 28 | 19 | <0.001 | |
| All | 508 | 16 | 647 | 26 | 10 | <0.001 | |
| ED | Nurse | 170 | 16 | 173 | 27 | 11 | 0.01 |
| Physician | 232 | 14 | 274 | 9 | ‐5 | 0.07 | |
| All | 402 | 15 | 447 | 16 | 1 | 0.64 | |
| All units | Nurse | 1385 | 21 | 1540 | 35 | 14 | <0.001 |
| Physician | 1294 | 15 | 1442 | 30 | 15 | <0.001 | |
| All | 2679 | 18 | 2982 | 33 | 15 | <0.001 | |
Hospital A achieved the highest postintervention adherence rates (39.9% adherence postintervention), as well as the greatest absolute improvement in hand hygiene (increase of 29.0%). There were significant improvements in 3 of the 4 participating units in hospital A, with the emergency department showing improvements only in the nurse subgroup. In hospital B, total hand hygiene adherence increased from 24.7% to 30.0% (P=0.01); however, this increase was mainly due to increase in hand hygiene adherence rates of nurses. There were significant increases in hand hygiene adherence rates for nurses in the medicine (+11%, P=0.04) and surgery wards (+14%, P=0.01), with nonsignificant increases for physicians (+10% medicine, P=0.07;+2% surgery, P=0.78). However, in the emergency department, nurses showed no significant improvement, and physicians had a significant decrease in adherence (15.7% preintervention vs 7.4% postintervention; P=0.02). In hospital C, total hand hygiene practice rates were significantly improved (from 18.9% to 26.5%; P<0.001); however, this was driven by improvements only in the surgical ward (14.6% preintervention to 42.3% postintervention; P<0.001). The rates for nurses declined significantly in both the medicine and ICU wards, leading to no observed improvements on those wards.
DISCUSSION
Our multicenter intervention study in Japan included observations from almost 3000 encounters between clinicians and patients. Before the intervention, the overall rate of hand hygiene adherence was 18%. After the multimodal intervention, the absolute increase in healthcare worker hand hygiene adherence was 15%. Although there was overall improvement, the adherence rates varied by hospital, with hospital A increasing by 29% and hospital B and C only attaining increases of 5% and 7%, respectively.
Despite the importance of hand hygiene of healthcare workers, it is challenging to increase hand hygiene adherence because it requires behavioral modification. Moreover, it remains uncertain what factors will affect healthcare worker behavior. We implemented pragmatic strategies to evaluate the efficacy of hand hygiene multimodal interventions based on internationally recognized WHO hand hygiene adherence strategies[11] and an institutional‐level contest with financial incentives. The findings in the current study help us understand not only how a multimodal intervention importantly improves hand hygiene adherence, but also what factors potentially make healthcare workers modify their behaviors.
In this study, we evaluated whether an institutional‐level contest with financial incentives contributed to improved hand hygiene adherence of healthcare workers. This study demonstrated improvement of hand hygiene practice after implementation of a multimodal hand hygiene intervention combined with an institutional‐level contest with financial incentives. The contest might have had a modest effect to help motivate the participating hospitals to improve their hand hygiene adherence rate. This is consistent with a previous study that demonstrated financial incentives were associated with modifying healthcare workers' hand hygiene practice.[21] However, we did not strictly standardize how the contest information was distributed in each participating institution and the objective assessment for changes in motivation by the contest was lacking in this study. Thus, changes in motivation by the contest with financial incentives likely varied by each participating institution. Further studies are needed to assess if this type of approach is worth pursuing.
We observed several noteworthy associations between the intervention components that were implemented at each facility and their improvement in hand hygiene adherence. Among the participating hospitals, hospital A was most successful with improving hand hygiene adherence, although all participating hospitals achieved a similar number of the 15 recommended intervention components during the intervention (8 to 10 per hospital). Interestingly, hospital A initiated the most new components during the intervention period (8 new components for a total of 10 out of 15), whereas hospital B and hospital C initiated only 1 or 2 new components during the intervention period. Hospital A also successfully involved hospital executives, and elicited the commitment of a nurse manager and physician leader. Consistent with a previous study,[22] we believe that involvement of hospital executives appears to be important to increase overall hand hygiene rate among healthcare workers.
In contrast, hospitals B and C did not involve senior executives or identify nurse or physician champions for all participating units. Based on the results in this study, we believe that the involvement of hospital executives is likely a key for the penetration of hospital‐wide hand hygiene culture among healthcare workers.
Although this study was unable to determine which components are precisely associated with improving hand hygiene adherence, the findings suggest initiating multiple intervention components at the same time may provide more motivation for change than initiating only 1 or 2 components at a time. It is also possible that certain intervention components were more beneficial than others. For example, hospital A, which achieved the most success, was the only hospital to obtain leadership support. Other studies have demonstrated that the presence of leadership appeared to play a key role in improving hand hygiene adherence.[23, 24] Moreover, a recent Japanese nationwide survey demonstrated higher safety centeredness was associated with regular use of standard infection prevention practice.[25] Consistent with a previous study, improving hand hygiene adherence cannot be simply achieved by improving infrastructure (eg, introduction of portable alcohol‐based hand rub) alone, but it depends on altering healthcare worker behavior.[26]
This study has several limitations. Because participating hospitals could tailor the specific interventions chosen for their facility, the improvement in hand hygiene adherence was likely multifactorial. We are unable in the existing study to determine a direct causal relationship between any of the individual intervention components and hand hygiene adherence. We are also unable to determine whether the improvements seen in hospital A were due to participation in the contest or due to the specific intervention components that were implemented. However, WHO hand hygiene guidelines point out that recognition of the importance of hand hygiene varies in different regions and countries, and the goal for hand hygiene interventions is to establish a culture of hand hygiene practice through pragmatic intervention strategies, frequent evaluation, and feedback to healthcare workers.[27] Thus, we prioritized pragmatic strategies to include in our intervention to promote hand hygiene adherence. Another limitation was the date of implementation of the multimodal intervention was slightly different at each facility. It was challenging to implement the intervention simultaneously across institutions due to competing priorities at each facility. Although the primary goal of hand hygiene is to reduce the burden of healthcare‐associated infection, we were unable to measure infection rates at the participating facilities. It is possible the presence of an external observer had an impact on the healthcare workers' behavior.[28] However, the healthcare workers were not informed as to what the observer was monitoring to minimize this potential effect. Lastly, the findings in this study provide immediate intervention effects but further study will be required to determine if these effects are sustainable.
Altering healthcare worker behavior is likely the key element to improve hand hygiene adherence, and behavioral modification may be achieved with the support of leadership at the unit and facility level. However, even though we found significant improvements in healthcare worker hand hygiene adherence after the intervention, the adherence rates are still relatively low compared to reported adherence rates from other countries,[29] suggesting further intervention is needed in this setting to optimize and hygiene practice. Because hand hygiene practice is a crucial strategy to prevent healthcare‐associated infections, every effort should be made to enhance the hand hygiene practice of healthcare workers.
Acknowledgements
The authors thank the International Ann Arbor Safety Collaborative (
Disclosure: Nothing to report.
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- , , , et al. Compliance of health care workers with hand hygiene practices: independent advantages of overt and covert observers. PLoS One. 2013;8(1):e53746.
- , , , et al. Systematic review of studies on compliance with hand hygiene guidelines in hospital care. Infect Control Hosp Epidemiol. 2010;31(3):283–294.
Healthcare‐associated infections are a major cause of illness and death in hospitalized patients, and preventing healthcare‐associated infection is a global challenge.[1] Worldwide, the prevalence of healthcare‐associated infections in developed and undeveloped countries ranges from 5.1% to 11.6% and 5.7% to 19.1%, respectively.[2] In the United States, roughly 2 million such infections occur annually, resulting in approximately 99,000 deaths[3] and estimated annual direct medical costs between $28.4 and $33.8 billion.[4] In Japan, nearly 9% of patients admitted to the intensive care unit (ICU) develop an infection during hospitalization,[5] and 5% of all patients hospitalized become infected with methicillin‐resistant Staphylococcus aureus.[6] The management of healthcare‐associated infections in Japan accounts for up to 5% of total annual healthcare costs, with an estimated $6.8 billion estimated to be potentially preventable.[7] In addition, healthcare‐associated infections are associated with increased length of stay in the hospital. Studies estimate surgical site infections extend length of stay by 9.7 days,[8] and bloodstream infections increase length of stay by 10 days.[9]
Improving hand hygiene practice for healthcare workers is considered a core strategy to decrease the incidence of healthcare‐associated infection.[6, 10] Specifically, the use of alcohol‐based hand rub is strongly recommended in acute care hospitals by both the World Health Organization (WHO) and the US Centers for Disease Control and Prevention.[11, 12] Improving hand hygiene adherence may reduce healthcare‐associated infection by 9% to 50%,[13, 14] and multiple studies have reported that greater use of alcohol‐based hand rubs results in significant reductions in healthcare‐associated infections.[14, 15]
Due to the difficulty in improving hand hygiene in various settings across the world, the WHO strategy for improving hand hygiene has been adopted and implemented by several studies in varying locations, such as Costa Rica, Italy, Mali, Pakistan, and Saudi Arabia.[16] Implementations of these multimodal strategies, following WHObased guidelines, have been shown to increase the level of hand hygiene adherence among healthcare workers and reduce infections at these locations.[14, 17, 18] This study expands upon that work by extending the same implementation strategy to assess the effectiveness of the introduction of alcohol‐based hand rub on hand hygiene practice at multiple hospitals in Japan.
In a previous article[19] we reported results from an observational study assessing healthcare worker hand hygiene adherence before touching the patient in 4 geographically diverse hospitals in Japan. The study reported that hand hygiene adherence in Japanese hospitals was lower than reported mean values from other international studies, and that greater adherence to hand hygiene should be encouraged. In this article, we present the results of a multimodal intervention intended to improve levels of healthcare worker hand hygiene in 3 of these hospitals.
METHODS
Participating Institutions
Three of the 4 hospitals participating in the prior observational study chose to participate in this intervention. Evaluation of hand hygiene practice was performed in at least 3 wards of each hospital including an inpatient surgical ward, an inpatient medicine ward, an ICU, or an emergency ward.
Table 1 lists the characteristics of the participating hospitals. Hospital A is a university‐affiliated, tertiary care medical center with 312 beds in East Japan. Although the hospital did not have an infection prevention unit or designated infection control nurses during the preintervention periods, the hospital hired a designated infection prevention nurse and established a department of infection prevention before this intervention in April 2012. Hospital B is a community‐based, tertiary care medical center with 428 beds, located in Midwest Japan. Although the facility had no infection control nurses at the outset of the study, a physician certified by the American Board of Internal Medicine and Infectious Diseases provided educational sessions of hand hygiene. Hospital B hired a designated infection prevention nurse and established a department of infection prevention in April 2012. Hospital C, located in Northern Japan, is a community‐based, tertiary care medical center with 562 beds. The department of infection prevention was established in 2010 and has 1 full‐time and 2 part‐time infection prevention nurses.
| Hospital A | Hospital B | Hospital C | ||||
|---|---|---|---|---|---|---|
| Preintervention | Postintervention | Preintervention | Postintervention | Preintervention | Postintervention | |
| ||||||
| Hospital characteristics | ||||||
| Location | East Japan | Midwest Japan | Northern Japan | |||
| Hospital type | University affiliated | Community based | Community based | |||
| Level of care | Tertiary care | Tertiary care | Tertiary care | |||
| Residency program | Yes | Yes | Yes | |||
| No. of beds | 250 | 312 | 428 | 428 | 550 | 562 |
| No. of employees | 398 | 475 | 1,035 | 1,263 | 1,500 | 1,568 |
| No. of physicians | 73 | 91 | 179 | 188 | 207 | 217 |
| No. of nurses | 172 | 210 | 410 | 540 | 616 | 800 |
| Infection control practice | ||||||
| Establishment of infection prevention units (year) | N/A | Yes (2012) | N/A | Yes (2012) | Yes (2010) | Yes |
| Employment of certified nurses in infection control (FTE) | 0 | 1 (1) | 0 | 1 (1) | 3 (1.5) | 3 (1.5) |
| Employment of ABIM‐IDcertified physician | 0 | 0 | 1 | 1 | 1 | 0 |
Role of the Funding Source
This study was unfunded. The prize for the contest was provided by an American collaborator (S.S.) who was not affiliated with any of the participating hospitals.
Intervention
In the prior preintervention study, hand hygiene adherence rates of healthcare workers were evaluated between July 2011 and November 2011.[19] To improve hand hygiene adherence in these facilities, we initiated a multimodal intervention based on WHO recommendations and the findings from the prior study. Each facility was provided the same guidance on how to improve hand hygiene adherence (Table 2) and encouraged to tailor the intervention to their local setting. As an added incentive, we initiated a contest, where the facility obtaining the highest hand hygiene adherence postintervention would win a trophy and 500,000 Japanese yen (approximately $5000 US dollars). The recommended strategies consisted of 15 components (Table 2): infrastructure (3 components), training and education (2 components), evaluation and feedback (5 components), reminder in the workplace (1 component), and institution safety climate (4 components). Of note, the participating institutions had already implemented a varying number of the intervention components prior to the start of the intervention. Each facility conducted a 6‐month intervention to improve hand hygiene adherence; however, the actual timing of interventions varied slightly by institution. Hospitals A and C conducted an intervention from October 2012 through March 2013, whereas hospital B's intervention was from April 2012 to September 2012. Details of the multimodal intervention performed at each participating hospital are shown in Table 3.
| Intervention Components | Description |
|---|---|
| 1. Infrastructure (3 components) | |
| Hand‐washing faucets for each room | At least 1 faucet and sink for each room was available. |
| Placement of alcohol hand rub at patient's room entrance | Alcohol hand rub was placed at all patient room entrances. |
| Portable alcohol hand rub distributed for each healthcare worker | Personal, portable alcohol hand rub dispensers were provided for healthcare workers who contact patients. |
| 2. Training/education (2 components) | |
| Educational resources | At least 1 physician or 1 nurse who provides educational sessions regarding hand hygiene practice was available. |
| Periodic seminars and lectures regarding hand hygiene education | Hospital‐wide hand hygiene seminar or educational activities were held during the intervention period. |
| 3. Evaluation and feedback (5 components) | |
| Evaluation of hand hygiene practice by direct observation | Hospitals utilize direct observation for healthcare worker's hand hygiene practice. |
| Evaluation of hand hygiene practice by monitoring the amount of alcohol hand rub consumption | Hospitals utilize the amount of alcohol hand rub consumption as a parameter for healthcare worker's hand hygiene practice. |
| Hand hygiene rate feedback at infection control committee | Hand hygiene adherence rate was reported and discussed at hospital infection control committee. |
| Hand hygiene rate feedback to the designated wards/units | Hand hygiene adherence rate was reported and discussed with healthcare workers at the designated wards/units where hand hygiene observation was performed. |
| Granting the award of top‐rated person of hand hygiene | Hospitals established the system to assess individual healthcare worker's hand hygiene adherence rate. |
| 4. Reminder in the workplace (1 components) | |
| Poster notification | Poster notification for hand hygiene practice was performed in the intervention period. |
| 5. Institutional safety climate (4 components) | |
| Commitment of hospital president or hospital executives | Hospital executives including the president agreed on the importance of hand hygiene practice and declared to healthcare workers to enhance hand hygiene practice during the intervention period. |
| Commitment of nurse managers and physician leaders | Commitment of improving hand hygiene practice by representative healthcare workers at the designated wards/units (eg, meeting by nurse manager or physician leaders at the designated wards/units and collaborative work with infection prevention services). |
| Meeting at the designated wards/units | A ward/unit‐level meeting or voluntary session for hands‐on hand hygiene practice by healthcare workers at the designated wards/units. |
| Identifying champions at the designated wards/units | An individual healthcare worker who contributed to improving hand hygiene practice was appointed. |
| Hospital A | Hospital Ba | Hospital C | ||||
|---|---|---|---|---|---|---|
| ||||||
| Intervention period | October 2012March 2013 | April 2012September 2012 | October 2012March 2013 | |||
| Evaluation of hand hygiene in the postintervention period | May 2013July 2013 | October 2012 | June 2013 | |||
| Suggested intervention components | Preintervention | Postintervention | Preintervention | Postintervention | Preintervention | Postintervention |
| No. of implemented components | 2/15 | 10/15 | 9/15 | 10/15 | 6/15 | 8/15 |
| Infrastructure (3 components) | ||||||
| Hand‐washing faucets for each room | No | No | Yes | Yes | Yes | Yes |
| Placement of alcohol hand rubs at patient's room entrance | Yes | Yes | Yes | Yes | Yes | Yes |
| Portable alcohol hand rub distributed for each healthcare worker | No | Yesb | No | Yesb | No | No |
| Training/education (2 components) | ||||||
| Educational resources | No | Yesb | Yes | Yesb | Yes | Yes |
| Periodic seminars and lectures regarding hand hygiene education | No | Yesb | Yes | Yes | Yes | Yes |
| Evaluation and feedback (5 components) | ||||||
| Evaluation of hand hygiene practice by direct observation | No | Yesb | Yes | Yes | No | No |
| Evaluation of hand hygiene practice by the amount of alcohol hand rub consumption | No | No | Yes | Yes | Yes | Yes |
| Hand hygiene rate feedback at infection control committee | No | Yesb | Yes | Yes | No | Yesb |
| Hand hygiene rate feedback to designated departments | No | Yesb | Yes | Yes | No | Yesb |
| Granting the award of top‐rated person | No | No | No | No | No | No |
| Reminders in the workplace (1 component) | ||||||
| Poster notification | Yes | Yes | Yes | Yes | Yes | Yes |
| 5. Institutional safety climate (4 components) | ||||||
| Commitment of hospital president or hospital executives | No | Yesb | No | No | No | No |
| Commitment of nurse managers and physicians leaders | No | Yesb | No | No | No | No |
| Meeting regarding hand hygiene practice by the designated wards/units | No | No | No | No | No | No |
| Identifying champions at the designated wards/units | No | No | No | No | No | No |
Observation of Hand Hygiene Practice
The same methods for hand hygiene observation used for the preintervention study was used for postintervention assessment. Ten distinct units across the 3 participating hospitals were evaluated for healthcare worker hand hygiene prior to patient contact. Three to 4 units were observed at each facility. One of the study authors (T.S.), a Japanese board‐certified infection control nurse, conducted all of the hand hygiene observations for both the preintervention and postintervention studies. Intraobserver variation was minimized by providing the same training outlined in the previous study.[19] Appropriate hand hygiene was defined as the use of soap and water or alcohol‐based hand rub before patient contact, which corresponds to the first moment of the WHO's 5 moments of hand hygiene.[11]
Hand hygiene practice prior to patient contact for each individual provider‐patient encounter was observed and recorded using the hand hygiene observation form adapted from a previous study by Saint et al.[6, 20] Identical to the preintervention study,[19] the form captured the following information: unit in which observations were performed, time of initiation and completion of observations, healthcare worker subgroup (physician or nurse), and the type of hand hygiene before patient contact (ie, hand washing with soap and water, use of alcohol‐based hand rub, or no hand hygiene). Unit physicians and nurses were informed that their clinical practices were going to be observed, but were not informed of the purpose of the observations (eg, hand hygiene adherence). To avoid interfering with clinical care delivery, the observer was given strict instructions to maintain a certain distance from the observed healthcare workers. The observer was instructed to leave immediately if asked for any reason by the unit staff or patients.
Statistical Analysis
Overall hand hygiene adherence rates were calculated and compared between the pre‐ and the postintervention periods. Comparison of hand hygiene adherence by healthcare worker subgroup and by hospital unit between the pre‐ and postintervention periods was also performed. Hand hygiene adherence rates were compared using JMP 9.0 and SAS 9.3 (SAS Institute Inc., Cary, NC). Comparison of hand hygiene adherence rates by observational periods was calculated by Pearson [2] tests, and 95% confidence intervals (CIs) were estimated using binomial distribution. Pearson correlations were used to determine the relationship of hand hygiene between physicians and nurses in the same unit. Two‐tailed P value0.05 was considered statistically significant. The study protocol was reviewed and approved by the ethics committees at the participating hospitals.
RESULTS
Data were collected from May 2013 to July 2013 in hospital A, in October 2012 in hospital B, and June 2013 in hospital C to ensure data were collected after the 6‐month intervention at each site. A total of 2982 observations of hand hygiene were performed in 10 distinct units across the 3 participating hospitals during the postintervention periods. Hand hygiene observations were performed during the day Monday through Friday between 8:30 am and 7:30 pm, with the majority occurring prior to 1:00 pm.
The overall postintervention hand hygiene adherence rate (in all 3 hospitals) was significantly higher at 32.7% (974/2982) adherence compared to 18.0% (482/2679) adherence in the preintervention period (P<0.001). An increased hand hygiene adherence rate in each participating hospital in the postintervention period was observed (Figure 1). Similar trends of higher overall hand hygiene adherence rates for both nurses and physicians in the postintervention period were seen. Use of alcohol‐based hand rub among those with appropriate hand hygiene was significantly higher, with 90.0% (880/974) using hand rub in the postintervention period versus 67.0% (322/482) in the preintervention period (P<0.001). Comparison of overall hand hygiene adherence rates by unit type and healthcare worker subgroup between the pre‐ and postintervention periods are shown in Table 4. Detailed comparisons of hand hygiene adherence rates for each hospital are available in the supplementary appendix. Although a significant improvement of hand hygiene practice was observed in the majority of participating units (6/10), there was a significant decline in hand hygiene practice in 2 units for nurses and 1 unit for physicians. Hand hygiene adherence rates by healthcare worker subgroups (both physicians and nurses) were significantly higher in the postintervention period than those in the preintervention period. Trends toward higher hand hygiene adherence rate of nurses in the postintervention period were observed (34.8% adherence for nurses compared to 30.4% adherence for physicians); the difference between nurses and physicians were not statistically significant (P=0.07).
| Ward/Unit | Healthcare Worker Subgroup | Preintervention Period | Postintervention Period | Improvement After Intervention (%) | P Value | ||
|---|---|---|---|---|---|---|---|
| No. of Observations | Hand hygiene Adherence (%) | No. of Observations | Hand Hygiene Adherence (%) | ||||
| |||||||
| All 3 hospitals | |||||||
| Surgery | Nurse | 455 | 20 | 480 | 40 | 20 | <0.001 |
| Physician | 424 | 18 | 448 | 43 | 25 | <0.001 | |
| All | 879 | 19 | 928 | 41 | 22 | <0.001 | |
| Medicine | Nurse | 455 | 23 | 508 | 39 | 16 | <0.001 |
| Physician | 435 | 15 | 452 | 33 | 18 | <0.001 | |
| All | 890 | 20 | 960 | 36 | 16 | <0.001 | |
| ICU | Nurse | 305 | 21 | 379 | 25 | 4 | 0.17 |
| Physician | 203 | 9 | 268 | 28 | 19 | <0.001 | |
| All | 508 | 16 | 647 | 26 | 10 | <0.001 | |
| ED | Nurse | 170 | 16 | 173 | 27 | 11 | 0.01 |
| Physician | 232 | 14 | 274 | 9 | ‐5 | 0.07 | |
| All | 402 | 15 | 447 | 16 | 1 | 0.64 | |
| All units | Nurse | 1385 | 21 | 1540 | 35 | 14 | <0.001 |
| Physician | 1294 | 15 | 1442 | 30 | 15 | <0.001 | |
| All | 2679 | 18 | 2982 | 33 | 15 | <0.001 | |
Hospital A achieved the highest postintervention adherence rates (39.9% adherence postintervention), as well as the greatest absolute improvement in hand hygiene (increase of 29.0%). There were significant improvements in 3 of the 4 participating units in hospital A, with the emergency department showing improvements only in the nurse subgroup. In hospital B, total hand hygiene adherence increased from 24.7% to 30.0% (P=0.01); however, this increase was mainly due to increase in hand hygiene adherence rates of nurses. There were significant increases in hand hygiene adherence rates for nurses in the medicine (+11%, P=0.04) and surgery wards (+14%, P=0.01), with nonsignificant increases for physicians (+10% medicine, P=0.07;+2% surgery, P=0.78). However, in the emergency department, nurses showed no significant improvement, and physicians had a significant decrease in adherence (15.7% preintervention vs 7.4% postintervention; P=0.02). In hospital C, total hand hygiene practice rates were significantly improved (from 18.9% to 26.5%; P<0.001); however, this was driven by improvements only in the surgical ward (14.6% preintervention to 42.3% postintervention; P<0.001). The rates for nurses declined significantly in both the medicine and ICU wards, leading to no observed improvements on those wards.
DISCUSSION
Our multicenter intervention study in Japan included observations from almost 3000 encounters between clinicians and patients. Before the intervention, the overall rate of hand hygiene adherence was 18%. After the multimodal intervention, the absolute increase in healthcare worker hand hygiene adherence was 15%. Although there was overall improvement, the adherence rates varied by hospital, with hospital A increasing by 29% and hospital B and C only attaining increases of 5% and 7%, respectively.
Despite the importance of hand hygiene of healthcare workers, it is challenging to increase hand hygiene adherence because it requires behavioral modification. Moreover, it remains uncertain what factors will affect healthcare worker behavior. We implemented pragmatic strategies to evaluate the efficacy of hand hygiene multimodal interventions based on internationally recognized WHO hand hygiene adherence strategies[11] and an institutional‐level contest with financial incentives. The findings in the current study help us understand not only how a multimodal intervention importantly improves hand hygiene adherence, but also what factors potentially make healthcare workers modify their behaviors.
In this study, we evaluated whether an institutional‐level contest with financial incentives contributed to improved hand hygiene adherence of healthcare workers. This study demonstrated improvement of hand hygiene practice after implementation of a multimodal hand hygiene intervention combined with an institutional‐level contest with financial incentives. The contest might have had a modest effect to help motivate the participating hospitals to improve their hand hygiene adherence rate. This is consistent with a previous study that demonstrated financial incentives were associated with modifying healthcare workers' hand hygiene practice.[21] However, we did not strictly standardize how the contest information was distributed in each participating institution and the objective assessment for changes in motivation by the contest was lacking in this study. Thus, changes in motivation by the contest with financial incentives likely varied by each participating institution. Further studies are needed to assess if this type of approach is worth pursuing.
We observed several noteworthy associations between the intervention components that were implemented at each facility and their improvement in hand hygiene adherence. Among the participating hospitals, hospital A was most successful with improving hand hygiene adherence, although all participating hospitals achieved a similar number of the 15 recommended intervention components during the intervention (8 to 10 per hospital). Interestingly, hospital A initiated the most new components during the intervention period (8 new components for a total of 10 out of 15), whereas hospital B and hospital C initiated only 1 or 2 new components during the intervention period. Hospital A also successfully involved hospital executives, and elicited the commitment of a nurse manager and physician leader. Consistent with a previous study,[22] we believe that involvement of hospital executives appears to be important to increase overall hand hygiene rate among healthcare workers.
In contrast, hospitals B and C did not involve senior executives or identify nurse or physician champions for all participating units. Based on the results in this study, we believe that the involvement of hospital executives is likely a key for the penetration of hospital‐wide hand hygiene culture among healthcare workers.
Although this study was unable to determine which components are precisely associated with improving hand hygiene adherence, the findings suggest initiating multiple intervention components at the same time may provide more motivation for change than initiating only 1 or 2 components at a time. It is also possible that certain intervention components were more beneficial than others. For example, hospital A, which achieved the most success, was the only hospital to obtain leadership support. Other studies have demonstrated that the presence of leadership appeared to play a key role in improving hand hygiene adherence.[23, 24] Moreover, a recent Japanese nationwide survey demonstrated higher safety centeredness was associated with regular use of standard infection prevention practice.[25] Consistent with a previous study, improving hand hygiene adherence cannot be simply achieved by improving infrastructure (eg, introduction of portable alcohol‐based hand rub) alone, but it depends on altering healthcare worker behavior.[26]
This study has several limitations. Because participating hospitals could tailor the specific interventions chosen for their facility, the improvement in hand hygiene adherence was likely multifactorial. We are unable in the existing study to determine a direct causal relationship between any of the individual intervention components and hand hygiene adherence. We are also unable to determine whether the improvements seen in hospital A were due to participation in the contest or due to the specific intervention components that were implemented. However, WHO hand hygiene guidelines point out that recognition of the importance of hand hygiene varies in different regions and countries, and the goal for hand hygiene interventions is to establish a culture of hand hygiene practice through pragmatic intervention strategies, frequent evaluation, and feedback to healthcare workers.[27] Thus, we prioritized pragmatic strategies to include in our intervention to promote hand hygiene adherence. Another limitation was the date of implementation of the multimodal intervention was slightly different at each facility. It was challenging to implement the intervention simultaneously across institutions due to competing priorities at each facility. Although the primary goal of hand hygiene is to reduce the burden of healthcare‐associated infection, we were unable to measure infection rates at the participating facilities. It is possible the presence of an external observer had an impact on the healthcare workers' behavior.[28] However, the healthcare workers were not informed as to what the observer was monitoring to minimize this potential effect. Lastly, the findings in this study provide immediate intervention effects but further study will be required to determine if these effects are sustainable.
Altering healthcare worker behavior is likely the key element to improve hand hygiene adherence, and behavioral modification may be achieved with the support of leadership at the unit and facility level. However, even though we found significant improvements in healthcare worker hand hygiene adherence after the intervention, the adherence rates are still relatively low compared to reported adherence rates from other countries,[29] suggesting further intervention is needed in this setting to optimize and hygiene practice. Because hand hygiene practice is a crucial strategy to prevent healthcare‐associated infections, every effort should be made to enhance the hand hygiene practice of healthcare workers.
Acknowledgements
The authors thank the International Ann Arbor Safety Collaborative (
Disclosure: Nothing to report.
Healthcare‐associated infections are a major cause of illness and death in hospitalized patients, and preventing healthcare‐associated infection is a global challenge.[1] Worldwide, the prevalence of healthcare‐associated infections in developed and undeveloped countries ranges from 5.1% to 11.6% and 5.7% to 19.1%, respectively.[2] In the United States, roughly 2 million such infections occur annually, resulting in approximately 99,000 deaths[3] and estimated annual direct medical costs between $28.4 and $33.8 billion.[4] In Japan, nearly 9% of patients admitted to the intensive care unit (ICU) develop an infection during hospitalization,[5] and 5% of all patients hospitalized become infected with methicillin‐resistant Staphylococcus aureus.[6] The management of healthcare‐associated infections in Japan accounts for up to 5% of total annual healthcare costs, with an estimated $6.8 billion estimated to be potentially preventable.[7] In addition, healthcare‐associated infections are associated with increased length of stay in the hospital. Studies estimate surgical site infections extend length of stay by 9.7 days,[8] and bloodstream infections increase length of stay by 10 days.[9]
Improving hand hygiene practice for healthcare workers is considered a core strategy to decrease the incidence of healthcare‐associated infection.[6, 10] Specifically, the use of alcohol‐based hand rub is strongly recommended in acute care hospitals by both the World Health Organization (WHO) and the US Centers for Disease Control and Prevention.[11, 12] Improving hand hygiene adherence may reduce healthcare‐associated infection by 9% to 50%,[13, 14] and multiple studies have reported that greater use of alcohol‐based hand rubs results in significant reductions in healthcare‐associated infections.[14, 15]
Due to the difficulty in improving hand hygiene in various settings across the world, the WHO strategy for improving hand hygiene has been adopted and implemented by several studies in varying locations, such as Costa Rica, Italy, Mali, Pakistan, and Saudi Arabia.[16] Implementations of these multimodal strategies, following WHObased guidelines, have been shown to increase the level of hand hygiene adherence among healthcare workers and reduce infections at these locations.[14, 17, 18] This study expands upon that work by extending the same implementation strategy to assess the effectiveness of the introduction of alcohol‐based hand rub on hand hygiene practice at multiple hospitals in Japan.
In a previous article[19] we reported results from an observational study assessing healthcare worker hand hygiene adherence before touching the patient in 4 geographically diverse hospitals in Japan. The study reported that hand hygiene adherence in Japanese hospitals was lower than reported mean values from other international studies, and that greater adherence to hand hygiene should be encouraged. In this article, we present the results of a multimodal intervention intended to improve levels of healthcare worker hand hygiene in 3 of these hospitals.
METHODS
Participating Institutions
Three of the 4 hospitals participating in the prior observational study chose to participate in this intervention. Evaluation of hand hygiene practice was performed in at least 3 wards of each hospital including an inpatient surgical ward, an inpatient medicine ward, an ICU, or an emergency ward.
Table 1 lists the characteristics of the participating hospitals. Hospital A is a university‐affiliated, tertiary care medical center with 312 beds in East Japan. Although the hospital did not have an infection prevention unit or designated infection control nurses during the preintervention periods, the hospital hired a designated infection prevention nurse and established a department of infection prevention before this intervention in April 2012. Hospital B is a community‐based, tertiary care medical center with 428 beds, located in Midwest Japan. Although the facility had no infection control nurses at the outset of the study, a physician certified by the American Board of Internal Medicine and Infectious Diseases provided educational sessions of hand hygiene. Hospital B hired a designated infection prevention nurse and established a department of infection prevention in April 2012. Hospital C, located in Northern Japan, is a community‐based, tertiary care medical center with 562 beds. The department of infection prevention was established in 2010 and has 1 full‐time and 2 part‐time infection prevention nurses.
| Hospital A | Hospital B | Hospital C | ||||
|---|---|---|---|---|---|---|
| Preintervention | Postintervention | Preintervention | Postintervention | Preintervention | Postintervention | |
| ||||||
| Hospital characteristics | ||||||
| Location | East Japan | Midwest Japan | Northern Japan | |||
| Hospital type | University affiliated | Community based | Community based | |||
| Level of care | Tertiary care | Tertiary care | Tertiary care | |||
| Residency program | Yes | Yes | Yes | |||
| No. of beds | 250 | 312 | 428 | 428 | 550 | 562 |
| No. of employees | 398 | 475 | 1,035 | 1,263 | 1,500 | 1,568 |
| No. of physicians | 73 | 91 | 179 | 188 | 207 | 217 |
| No. of nurses | 172 | 210 | 410 | 540 | 616 | 800 |
| Infection control practice | ||||||
| Establishment of infection prevention units (year) | N/A | Yes (2012) | N/A | Yes (2012) | Yes (2010) | Yes |
| Employment of certified nurses in infection control (FTE) | 0 | 1 (1) | 0 | 1 (1) | 3 (1.5) | 3 (1.5) |
| Employment of ABIM‐IDcertified physician | 0 | 0 | 1 | 1 | 1 | 0 |
Role of the Funding Source
This study was unfunded. The prize for the contest was provided by an American collaborator (S.S.) who was not affiliated with any of the participating hospitals.
Intervention
In the prior preintervention study, hand hygiene adherence rates of healthcare workers were evaluated between July 2011 and November 2011.[19] To improve hand hygiene adherence in these facilities, we initiated a multimodal intervention based on WHO recommendations and the findings from the prior study. Each facility was provided the same guidance on how to improve hand hygiene adherence (Table 2) and encouraged to tailor the intervention to their local setting. As an added incentive, we initiated a contest, where the facility obtaining the highest hand hygiene adherence postintervention would win a trophy and 500,000 Japanese yen (approximately $5000 US dollars). The recommended strategies consisted of 15 components (Table 2): infrastructure (3 components), training and education (2 components), evaluation and feedback (5 components), reminder in the workplace (1 component), and institution safety climate (4 components). Of note, the participating institutions had already implemented a varying number of the intervention components prior to the start of the intervention. Each facility conducted a 6‐month intervention to improve hand hygiene adherence; however, the actual timing of interventions varied slightly by institution. Hospitals A and C conducted an intervention from October 2012 through March 2013, whereas hospital B's intervention was from April 2012 to September 2012. Details of the multimodal intervention performed at each participating hospital are shown in Table 3.
| Intervention Components | Description |
|---|---|
| 1. Infrastructure (3 components) | |
| Hand‐washing faucets for each room | At least 1 faucet and sink for each room was available. |
| Placement of alcohol hand rub at patient's room entrance | Alcohol hand rub was placed at all patient room entrances. |
| Portable alcohol hand rub distributed for each healthcare worker | Personal, portable alcohol hand rub dispensers were provided for healthcare workers who contact patients. |
| 2. Training/education (2 components) | |
| Educational resources | At least 1 physician or 1 nurse who provides educational sessions regarding hand hygiene practice was available. |
| Periodic seminars and lectures regarding hand hygiene education | Hospital‐wide hand hygiene seminar or educational activities were held during the intervention period. |
| 3. Evaluation and feedback (5 components) | |
| Evaluation of hand hygiene practice by direct observation | Hospitals utilize direct observation for healthcare worker's hand hygiene practice. |
| Evaluation of hand hygiene practice by monitoring the amount of alcohol hand rub consumption | Hospitals utilize the amount of alcohol hand rub consumption as a parameter for healthcare worker's hand hygiene practice. |
| Hand hygiene rate feedback at infection control committee | Hand hygiene adherence rate was reported and discussed at hospital infection control committee. |
| Hand hygiene rate feedback to the designated wards/units | Hand hygiene adherence rate was reported and discussed with healthcare workers at the designated wards/units where hand hygiene observation was performed. |
| Granting the award of top‐rated person of hand hygiene | Hospitals established the system to assess individual healthcare worker's hand hygiene adherence rate. |
| 4. Reminder in the workplace (1 components) | |
| Poster notification | Poster notification for hand hygiene practice was performed in the intervention period. |
| 5. Institutional safety climate (4 components) | |
| Commitment of hospital president or hospital executives | Hospital executives including the president agreed on the importance of hand hygiene practice and declared to healthcare workers to enhance hand hygiene practice during the intervention period. |
| Commitment of nurse managers and physician leaders | Commitment of improving hand hygiene practice by representative healthcare workers at the designated wards/units (eg, meeting by nurse manager or physician leaders at the designated wards/units and collaborative work with infection prevention services). |
| Meeting at the designated wards/units | A ward/unit‐level meeting or voluntary session for hands‐on hand hygiene practice by healthcare workers at the designated wards/units. |
| Identifying champions at the designated wards/units | An individual healthcare worker who contributed to improving hand hygiene practice was appointed. |
| Hospital A | Hospital Ba | Hospital C | ||||
|---|---|---|---|---|---|---|
| ||||||
| Intervention period | October 2012March 2013 | April 2012September 2012 | October 2012March 2013 | |||
| Evaluation of hand hygiene in the postintervention period | May 2013July 2013 | October 2012 | June 2013 | |||
| Suggested intervention components | Preintervention | Postintervention | Preintervention | Postintervention | Preintervention | Postintervention |
| No. of implemented components | 2/15 | 10/15 | 9/15 | 10/15 | 6/15 | 8/15 |
| Infrastructure (3 components) | ||||||
| Hand‐washing faucets for each room | No | No | Yes | Yes | Yes | Yes |
| Placement of alcohol hand rubs at patient's room entrance | Yes | Yes | Yes | Yes | Yes | Yes |
| Portable alcohol hand rub distributed for each healthcare worker | No | Yesb | No | Yesb | No | No |
| Training/education (2 components) | ||||||
| Educational resources | No | Yesb | Yes | Yesb | Yes | Yes |
| Periodic seminars and lectures regarding hand hygiene education | No | Yesb | Yes | Yes | Yes | Yes |
| Evaluation and feedback (5 components) | ||||||
| Evaluation of hand hygiene practice by direct observation | No | Yesb | Yes | Yes | No | No |
| Evaluation of hand hygiene practice by the amount of alcohol hand rub consumption | No | No | Yes | Yes | Yes | Yes |
| Hand hygiene rate feedback at infection control committee | No | Yesb | Yes | Yes | No | Yesb |
| Hand hygiene rate feedback to designated departments | No | Yesb | Yes | Yes | No | Yesb |
| Granting the award of top‐rated person | No | No | No | No | No | No |
| Reminders in the workplace (1 component) | ||||||
| Poster notification | Yes | Yes | Yes | Yes | Yes | Yes |
| 5. Institutional safety climate (4 components) | ||||||
| Commitment of hospital president or hospital executives | No | Yesb | No | No | No | No |
| Commitment of nurse managers and physicians leaders | No | Yesb | No | No | No | No |
| Meeting regarding hand hygiene practice by the designated wards/units | No | No | No | No | No | No |
| Identifying champions at the designated wards/units | No | No | No | No | No | No |
Observation of Hand Hygiene Practice
The same methods for hand hygiene observation used for the preintervention study was used for postintervention assessment. Ten distinct units across the 3 participating hospitals were evaluated for healthcare worker hand hygiene prior to patient contact. Three to 4 units were observed at each facility. One of the study authors (T.S.), a Japanese board‐certified infection control nurse, conducted all of the hand hygiene observations for both the preintervention and postintervention studies. Intraobserver variation was minimized by providing the same training outlined in the previous study.[19] Appropriate hand hygiene was defined as the use of soap and water or alcohol‐based hand rub before patient contact, which corresponds to the first moment of the WHO's 5 moments of hand hygiene.[11]
Hand hygiene practice prior to patient contact for each individual provider‐patient encounter was observed and recorded using the hand hygiene observation form adapted from a previous study by Saint et al.[6, 20] Identical to the preintervention study,[19] the form captured the following information: unit in which observations were performed, time of initiation and completion of observations, healthcare worker subgroup (physician or nurse), and the type of hand hygiene before patient contact (ie, hand washing with soap and water, use of alcohol‐based hand rub, or no hand hygiene). Unit physicians and nurses were informed that their clinical practices were going to be observed, but were not informed of the purpose of the observations (eg, hand hygiene adherence). To avoid interfering with clinical care delivery, the observer was given strict instructions to maintain a certain distance from the observed healthcare workers. The observer was instructed to leave immediately if asked for any reason by the unit staff or patients.
Statistical Analysis
Overall hand hygiene adherence rates were calculated and compared between the pre‐ and the postintervention periods. Comparison of hand hygiene adherence by healthcare worker subgroup and by hospital unit between the pre‐ and postintervention periods was also performed. Hand hygiene adherence rates were compared using JMP 9.0 and SAS 9.3 (SAS Institute Inc., Cary, NC). Comparison of hand hygiene adherence rates by observational periods was calculated by Pearson [2] tests, and 95% confidence intervals (CIs) were estimated using binomial distribution. Pearson correlations were used to determine the relationship of hand hygiene between physicians and nurses in the same unit. Two‐tailed P value0.05 was considered statistically significant. The study protocol was reviewed and approved by the ethics committees at the participating hospitals.
RESULTS
Data were collected from May 2013 to July 2013 in hospital A, in October 2012 in hospital B, and June 2013 in hospital C to ensure data were collected after the 6‐month intervention at each site. A total of 2982 observations of hand hygiene were performed in 10 distinct units across the 3 participating hospitals during the postintervention periods. Hand hygiene observations were performed during the day Monday through Friday between 8:30 am and 7:30 pm, with the majority occurring prior to 1:00 pm.
The overall postintervention hand hygiene adherence rate (in all 3 hospitals) was significantly higher at 32.7% (974/2982) adherence compared to 18.0% (482/2679) adherence in the preintervention period (P<0.001). An increased hand hygiene adherence rate in each participating hospital in the postintervention period was observed (Figure 1). Similar trends of higher overall hand hygiene adherence rates for both nurses and physicians in the postintervention period were seen. Use of alcohol‐based hand rub among those with appropriate hand hygiene was significantly higher, with 90.0% (880/974) using hand rub in the postintervention period versus 67.0% (322/482) in the preintervention period (P<0.001). Comparison of overall hand hygiene adherence rates by unit type and healthcare worker subgroup between the pre‐ and postintervention periods are shown in Table 4. Detailed comparisons of hand hygiene adherence rates for each hospital are available in the supplementary appendix. Although a significant improvement of hand hygiene practice was observed in the majority of participating units (6/10), there was a significant decline in hand hygiene practice in 2 units for nurses and 1 unit for physicians. Hand hygiene adherence rates by healthcare worker subgroups (both physicians and nurses) were significantly higher in the postintervention period than those in the preintervention period. Trends toward higher hand hygiene adherence rate of nurses in the postintervention period were observed (34.8% adherence for nurses compared to 30.4% adherence for physicians); the difference between nurses and physicians were not statistically significant (P=0.07).
| Ward/Unit | Healthcare Worker Subgroup | Preintervention Period | Postintervention Period | Improvement After Intervention (%) | P Value | ||
|---|---|---|---|---|---|---|---|
| No. of Observations | Hand hygiene Adherence (%) | No. of Observations | Hand Hygiene Adherence (%) | ||||
| |||||||
| All 3 hospitals | |||||||
| Surgery | Nurse | 455 | 20 | 480 | 40 | 20 | <0.001 |
| Physician | 424 | 18 | 448 | 43 | 25 | <0.001 | |
| All | 879 | 19 | 928 | 41 | 22 | <0.001 | |
| Medicine | Nurse | 455 | 23 | 508 | 39 | 16 | <0.001 |
| Physician | 435 | 15 | 452 | 33 | 18 | <0.001 | |
| All | 890 | 20 | 960 | 36 | 16 | <0.001 | |
| ICU | Nurse | 305 | 21 | 379 | 25 | 4 | 0.17 |
| Physician | 203 | 9 | 268 | 28 | 19 | <0.001 | |
| All | 508 | 16 | 647 | 26 | 10 | <0.001 | |
| ED | Nurse | 170 | 16 | 173 | 27 | 11 | 0.01 |
| Physician | 232 | 14 | 274 | 9 | ‐5 | 0.07 | |
| All | 402 | 15 | 447 | 16 | 1 | 0.64 | |
| All units | Nurse | 1385 | 21 | 1540 | 35 | 14 | <0.001 |
| Physician | 1294 | 15 | 1442 | 30 | 15 | <0.001 | |
| All | 2679 | 18 | 2982 | 33 | 15 | <0.001 | |
Hospital A achieved the highest postintervention adherence rates (39.9% adherence postintervention), as well as the greatest absolute improvement in hand hygiene (increase of 29.0%). There were significant improvements in 3 of the 4 participating units in hospital A, with the emergency department showing improvements only in the nurse subgroup. In hospital B, total hand hygiene adherence increased from 24.7% to 30.0% (P=0.01); however, this increase was mainly due to increase in hand hygiene adherence rates of nurses. There were significant increases in hand hygiene adherence rates for nurses in the medicine (+11%, P=0.04) and surgery wards (+14%, P=0.01), with nonsignificant increases for physicians (+10% medicine, P=0.07;+2% surgery, P=0.78). However, in the emergency department, nurses showed no significant improvement, and physicians had a significant decrease in adherence (15.7% preintervention vs 7.4% postintervention; P=0.02). In hospital C, total hand hygiene practice rates were significantly improved (from 18.9% to 26.5%; P<0.001); however, this was driven by improvements only in the surgical ward (14.6% preintervention to 42.3% postintervention; P<0.001). The rates for nurses declined significantly in both the medicine and ICU wards, leading to no observed improvements on those wards.
DISCUSSION
Our multicenter intervention study in Japan included observations from almost 3000 encounters between clinicians and patients. Before the intervention, the overall rate of hand hygiene adherence was 18%. After the multimodal intervention, the absolute increase in healthcare worker hand hygiene adherence was 15%. Although there was overall improvement, the adherence rates varied by hospital, with hospital A increasing by 29% and hospital B and C only attaining increases of 5% and 7%, respectively.
Despite the importance of hand hygiene of healthcare workers, it is challenging to increase hand hygiene adherence because it requires behavioral modification. Moreover, it remains uncertain what factors will affect healthcare worker behavior. We implemented pragmatic strategies to evaluate the efficacy of hand hygiene multimodal interventions based on internationally recognized WHO hand hygiene adherence strategies[11] and an institutional‐level contest with financial incentives. The findings in the current study help us understand not only how a multimodal intervention importantly improves hand hygiene adherence, but also what factors potentially make healthcare workers modify their behaviors.
In this study, we evaluated whether an institutional‐level contest with financial incentives contributed to improved hand hygiene adherence of healthcare workers. This study demonstrated improvement of hand hygiene practice after implementation of a multimodal hand hygiene intervention combined with an institutional‐level contest with financial incentives. The contest might have had a modest effect to help motivate the participating hospitals to improve their hand hygiene adherence rate. This is consistent with a previous study that demonstrated financial incentives were associated with modifying healthcare workers' hand hygiene practice.[21] However, we did not strictly standardize how the contest information was distributed in each participating institution and the objective assessment for changes in motivation by the contest was lacking in this study. Thus, changes in motivation by the contest with financial incentives likely varied by each participating institution. Further studies are needed to assess if this type of approach is worth pursuing.
We observed several noteworthy associations between the intervention components that were implemented at each facility and their improvement in hand hygiene adherence. Among the participating hospitals, hospital A was most successful with improving hand hygiene adherence, although all participating hospitals achieved a similar number of the 15 recommended intervention components during the intervention (8 to 10 per hospital). Interestingly, hospital A initiated the most new components during the intervention period (8 new components for a total of 10 out of 15), whereas hospital B and hospital C initiated only 1 or 2 new components during the intervention period. Hospital A also successfully involved hospital executives, and elicited the commitment of a nurse manager and physician leader. Consistent with a previous study,[22] we believe that involvement of hospital executives appears to be important to increase overall hand hygiene rate among healthcare workers.
In contrast, hospitals B and C did not involve senior executives or identify nurse or physician champions for all participating units. Based on the results in this study, we believe that the involvement of hospital executives is likely a key for the penetration of hospital‐wide hand hygiene culture among healthcare workers.
Although this study was unable to determine which components are precisely associated with improving hand hygiene adherence, the findings suggest initiating multiple intervention components at the same time may provide more motivation for change than initiating only 1 or 2 components at a time. It is also possible that certain intervention components were more beneficial than others. For example, hospital A, which achieved the most success, was the only hospital to obtain leadership support. Other studies have demonstrated that the presence of leadership appeared to play a key role in improving hand hygiene adherence.[23, 24] Moreover, a recent Japanese nationwide survey demonstrated higher safety centeredness was associated with regular use of standard infection prevention practice.[25] Consistent with a previous study, improving hand hygiene adherence cannot be simply achieved by improving infrastructure (eg, introduction of portable alcohol‐based hand rub) alone, but it depends on altering healthcare worker behavior.[26]
This study has several limitations. Because participating hospitals could tailor the specific interventions chosen for their facility, the improvement in hand hygiene adherence was likely multifactorial. We are unable in the existing study to determine a direct causal relationship between any of the individual intervention components and hand hygiene adherence. We are also unable to determine whether the improvements seen in hospital A were due to participation in the contest or due to the specific intervention components that were implemented. However, WHO hand hygiene guidelines point out that recognition of the importance of hand hygiene varies in different regions and countries, and the goal for hand hygiene interventions is to establish a culture of hand hygiene practice through pragmatic intervention strategies, frequent evaluation, and feedback to healthcare workers.[27] Thus, we prioritized pragmatic strategies to include in our intervention to promote hand hygiene adherence. Another limitation was the date of implementation of the multimodal intervention was slightly different at each facility. It was challenging to implement the intervention simultaneously across institutions due to competing priorities at each facility. Although the primary goal of hand hygiene is to reduce the burden of healthcare‐associated infection, we were unable to measure infection rates at the participating facilities. It is possible the presence of an external observer had an impact on the healthcare workers' behavior.[28] However, the healthcare workers were not informed as to what the observer was monitoring to minimize this potential effect. Lastly, the findings in this study provide immediate intervention effects but further study will be required to determine if these effects are sustainable.
Altering healthcare worker behavior is likely the key element to improve hand hygiene adherence, and behavioral modification may be achieved with the support of leadership at the unit and facility level. However, even though we found significant improvements in healthcare worker hand hygiene adherence after the intervention, the adherence rates are still relatively low compared to reported adherence rates from other countries,[29] suggesting further intervention is needed in this setting to optimize and hygiene practice. Because hand hygiene practice is a crucial strategy to prevent healthcare‐associated infections, every effort should be made to enhance the hand hygiene practice of healthcare workers.
Acknowledgements
The authors thank the International Ann Arbor Safety Collaborative (
Disclosure: Nothing to report.
- . Infection control—a problem for patient safety. N Engl J Med. 2003;348(7):651–656.
- World Health Organization. The burden of health care‐associated infection worldwide: a summary. Available at: http://www.who.int/gpsc/country_work/summary_20100430_en.pdf. Accessed October 6, 2014.
- , , , et al. Estimating health care‐associated infections and deaths in U.S. hospitals, 2002. Public Health Rep. 2007;122(2):160–166.
- . The direct medical costs of healthcare‐associated infections in U.S. hospitals and the benefits of prevention. Atlanta, GA: Centers for Disease Control and Prevention; 2009. Available at: http://www.cdc.gov/HAI/pdfs/hai/Scott_CostPaper.pdf. Accessed April 20, 2015.
- , , . Epidemiological approach to nosocomial infection surveillance data: the Japanese Nosocomial Infection Surveillance System. Environ Health Prev Med. 2008;13(1):30–35.
- , , , et al. Improving healthcare worker hand hygiene adherence before patient contact: a before‐and‐after five‐unit multimodal intervention in Tuscany. Qual Saf Health Care. 2009;18(6):429–433.
- . Economical efficiency of infection control. Antibiot Chemother (Northfield). 2004;20:635–638.
- , , , , , . Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009;37(5):387–397.
- , , , , , . Hospital‐acquired, laboratory‐confirmed bloodstream infections: linking national surveillance data to clinical and financial hospital data to estimate increased length of stay and healthcare costs. J Hosp Infect. 2010;75(3):158–162.
- . APIC guideline for handwashing and hand antisepsis in health care settings. Am J Infect Control. 1995;23(4):251–269.
- World Health Organization. WHO Guidelines on Hand Hygiene in Health Care. Clean care is safer care: first global patient safety challenge. Geneva, Switzerland; 2009. Available at: http://www.who.int/gpsc/en/index.html. Accessed October 6, 2014.
- , ; Healthcare Infection Control Practices Advisory Committee, HICPAC SHEA APIC IDSA Hand Hygiene Task Force. Guideline for hand hygiene in health‐care settings. Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Society for Healthcare Epidemiology of America/Association for Professionals in Infection Control/Infectious Diseases Society of America. MMWR Recomm Rep. 2002;51(RR‐16):1–45.
- National Patient Safety Agency. The economic case: implementing near‐patient alcohol hand rum in your trust. London, United Kingdom; 2004. Available at: http://www.npsa.nhs.uk/cleanyourhands/resource‐area/evidence‐base/?EntryId34=58433. Accessed October 9, 2014.
- , , , et al. Effectiveness of a hospital‐wide programme to improve compliance with hand hygiene. Infection Control Programme. Lancet. 2000;356(9238):1307–1312.
- , . Role of hand hygiene in healthcare‐associated infection prevention. J Hosp Infect. 2009;73(4):305–315.
- , , , et al. Global implementation of WHO's multimodal strategy for improvement of hand hygiene: a quasi‐experimental study. Lancet Infect Dis. 2013;13(10):843–851.
- , , , et al. Impact of the International Nosocomial Infection Control Consortium (INICC) multidimensional hand hygiene approach over 13 years in 51 cities of 19 limited‐resource countries from Latin America, Asia, the Middle East, and Europe. Infect Control Hosp Epidemiol. 2013;34(4):415–423.
- , , , . Bundling hand hygiene interventions and measurement to decrease health care‐associated infections. Am J Infect Control. 2012;40(4 suppl 1):S18–S27.
- , , , et al. Hand hygiene adherence among health care workers at Japanese hospitals: a multicenter observational study in Japan [published online April 8, 2014]. J Patient Saf. doi: 10.1097/PTS.0000000000000108.
- , , , et al. Marked variability in adherence to hand hygiene: a 5‐unit observational study in Tuscany. Am J Infect Control. 2009;37(4):306–310.
- , , , et al. Sustained improvement in hand hygiene adherence: utilizing shared accountability and financial incentives. Infect Control Hosp Epidemiol. 2013;34(11):1129–1136.
- , , , . Status of the implementation of the World Health Organization multimodal hand hygiene strategy in United States of America health care facilities. Am J Infect Control. 2014;42(3):224–230.
- , , , et al. The effect of leadership on hand hygiene: assessing hand hygiene adherence prior to patient contact in 2 infectious disease units in Tuscany. Infect Control Hosp Epidemiol. 2014;35(3):313–316.
- , , , , , . Impact of a hospital‐wide hand hygiene initiative on healthcare‐associated infections: results of an interrupted time series. BMJ Qual Saf. 2012;21(12):1019–1026.
- , , , , , . Health care‐associated infection prevention in Japan: the role of safety culture. Am J Infect Control. 2014;42(8):888–893.
- , , . Why healthcare workers don't wash their hands: a behavioral explanation. Infect Control Hosp Epidemiol. 2006;27(5):484–492.
- World Health Organization. Guide to implementation. A guide to the implementation of the WHO multimodal hand hygiene improvement strategy. Available at: http://whqlibdoc.who.int/hq/2009/WHO_IER_PSP_2009.02_eng.pdf. Accessed October 9, 2014.
- , , , et al. Compliance of health care workers with hand hygiene practices: independent advantages of overt and covert observers. PLoS One. 2013;8(1):e53746.
- , , , et al. Systematic review of studies on compliance with hand hygiene guidelines in hospital care. Infect Control Hosp Epidemiol. 2010;31(3):283–294.
- . Infection control—a problem for patient safety. N Engl J Med. 2003;348(7):651–656.
- World Health Organization. The burden of health care‐associated infection worldwide: a summary. Available at: http://www.who.int/gpsc/country_work/summary_20100430_en.pdf. Accessed October 6, 2014.
- , , , et al. Estimating health care‐associated infections and deaths in U.S. hospitals, 2002. Public Health Rep. 2007;122(2):160–166.
- . The direct medical costs of healthcare‐associated infections in U.S. hospitals and the benefits of prevention. Atlanta, GA: Centers for Disease Control and Prevention; 2009. Available at: http://www.cdc.gov/HAI/pdfs/hai/Scott_CostPaper.pdf. Accessed April 20, 2015.
- , , . Epidemiological approach to nosocomial infection surveillance data: the Japanese Nosocomial Infection Surveillance System. Environ Health Prev Med. 2008;13(1):30–35.
- , , , et al. Improving healthcare worker hand hygiene adherence before patient contact: a before‐and‐after five‐unit multimodal intervention in Tuscany. Qual Saf Health Care. 2009;18(6):429–433.
- . Economical efficiency of infection control. Antibiot Chemother (Northfield). 2004;20:635–638.
- , , , , , . Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009;37(5):387–397.
- , , , , , . Hospital‐acquired, laboratory‐confirmed bloodstream infections: linking national surveillance data to clinical and financial hospital data to estimate increased length of stay and healthcare costs. J Hosp Infect. 2010;75(3):158–162.
- . APIC guideline for handwashing and hand antisepsis in health care settings. Am J Infect Control. 1995;23(4):251–269.
- World Health Organization. WHO Guidelines on Hand Hygiene in Health Care. Clean care is safer care: first global patient safety challenge. Geneva, Switzerland; 2009. Available at: http://www.who.int/gpsc/en/index.html. Accessed October 6, 2014.
- , ; Healthcare Infection Control Practices Advisory Committee, HICPAC SHEA APIC IDSA Hand Hygiene Task Force. Guideline for hand hygiene in health‐care settings. Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Society for Healthcare Epidemiology of America/Association for Professionals in Infection Control/Infectious Diseases Society of America. MMWR Recomm Rep. 2002;51(RR‐16):1–45.
- National Patient Safety Agency. The economic case: implementing near‐patient alcohol hand rum in your trust. London, United Kingdom; 2004. Available at: http://www.npsa.nhs.uk/cleanyourhands/resource‐area/evidence‐base/?EntryId34=58433. Accessed October 9, 2014.
- , , , et al. Effectiveness of a hospital‐wide programme to improve compliance with hand hygiene. Infection Control Programme. Lancet. 2000;356(9238):1307–1312.
- , . Role of hand hygiene in healthcare‐associated infection prevention. J Hosp Infect. 2009;73(4):305–315.
- , , , et al. Global implementation of WHO's multimodal strategy for improvement of hand hygiene: a quasi‐experimental study. Lancet Infect Dis. 2013;13(10):843–851.
- , , , et al. Impact of the International Nosocomial Infection Control Consortium (INICC) multidimensional hand hygiene approach over 13 years in 51 cities of 19 limited‐resource countries from Latin America, Asia, the Middle East, and Europe. Infect Control Hosp Epidemiol. 2013;34(4):415–423.
- , , , . Bundling hand hygiene interventions and measurement to decrease health care‐associated infections. Am J Infect Control. 2012;40(4 suppl 1):S18–S27.
- , , , et al. Hand hygiene adherence among health care workers at Japanese hospitals: a multicenter observational study in Japan [published online April 8, 2014]. J Patient Saf. doi: 10.1097/PTS.0000000000000108.
- , , , et al. Marked variability in adherence to hand hygiene: a 5‐unit observational study in Tuscany. Am J Infect Control. 2009;37(4):306–310.
- , , , et al. Sustained improvement in hand hygiene adherence: utilizing shared accountability and financial incentives. Infect Control Hosp Epidemiol. 2013;34(11):1129–1136.
- , , , . Status of the implementation of the World Health Organization multimodal hand hygiene strategy in United States of America health care facilities. Am J Infect Control. 2014;42(3):224–230.
- , , , et al. The effect of leadership on hand hygiene: assessing hand hygiene adherence prior to patient contact in 2 infectious disease units in Tuscany. Infect Control Hosp Epidemiol. 2014;35(3):313–316.
- , , , , , . Impact of a hospital‐wide hand hygiene initiative on healthcare‐associated infections: results of an interrupted time series. BMJ Qual Saf. 2012;21(12):1019–1026.
- , , , , , . Health care‐associated infection prevention in Japan: the role of safety culture. Am J Infect Control. 2014;42(8):888–893.
- , , . Why healthcare workers don't wash their hands: a behavioral explanation. Infect Control Hosp Epidemiol. 2006;27(5):484–492.
- World Health Organization. Guide to implementation. A guide to the implementation of the WHO multimodal hand hygiene improvement strategy. Available at: http://whqlibdoc.who.int/hq/2009/WHO_IER_PSP_2009.02_eng.pdf. Accessed October 9, 2014.
- , , , et al. Compliance of health care workers with hand hygiene practices: independent advantages of overt and covert observers. PLoS One. 2013;8(1):e53746.
- , , , et al. Systematic review of studies on compliance with hand hygiene guidelines in hospital care. Infect Control Hosp Epidemiol. 2010;31(3):283–294.
© 2015 Society of Hospital Medicine
Invasive Compartment Pressure Testing for Chronic Exertional Compartment Syndrome: A Survey of Clinical Practice Among Military Orthopedic Surgeons
Chronic exertional compartment syndrome (CECS) is a common cause of leg pain during exertion in athletic and active-duty populations.1 It is caused by an increase in intramuscular pressure to a point that the tissues within the involved compartment become ischemic because of a decrease in arteriolar blood flow.2 This relative ischemia causes pain and may also be associated with neurologic symptoms. By definition, the pain associated with CECS resolves with rest. Patients typically describe a feeling of fullness or tightness, which eventually evolves into pain as they continue exercising. Pain onset is usually predictable and reproducible after a finite amount of time and/or intensity of exercise.
The differential diagnosis of leg pain during exercise includes CECS, medial tibial stress syndrome, popliteal entrapment syndrome, myopathy, peripheral nerve entrapment syndromes, stress fracture, and effort-induced rhabdomyolysis.3 CECS can be differentiated from other causes of leg pain with measurement of compartment pressures (the standard recommendation).4 Compartment pressure measurement, however, is invasive, time-consuming, and painful and may be associated with bleeding risk, infection, and nerve injury. Noninvasive means of testing for CECS (eg, magnetic resonance imaging [MRI], near-infrared spectroscopy [NIRS], thallium stress testing) remain experimental and expensive and are not easily accessible at all institutions.5-8 While invasive compartment pressure (ICP) testing remains an important tool in the diagnosis of CECS, its criteria and execution vary considerably. Aweid and colleagues4 performed a meta-analysis of use of ICP testing in the diagnosis of CECS and concluded that, though elevated ICP measurements are accepted as the gold standard for diagnosing CECS, the criteria outlined for a positive test lack high-level supporting evidence. In addition, how the test is performed has been inconsistent across studies—further clouding the literature.4
The review by Aweid and colleagues4 highlights the deficiencies in diagnosing CECS by ICP testing. In clinical practice, ICP testing is challenging for both the patient and physician. As other validated, less-invasive tests are lacking, emphasis should remain on the history and the physical examination. Although all athletic populations are at risk for CECS, the active-duty military population is at particularly high risk because of the physical requirements and demands of military service.1,9
We surveyed military orthopedic surgeons to investigate the clinical practice of performing ICP testing in patients with suspected CECS. We hypothesized that the rate of ICP testing among military orthopedic surgeons would not be 100% for patients with the typical signs and symptoms of CECS.
Materials and Methods
This study was approved by the institutional review board at Wright-Patterson Medical Center at Wright-Patterson Air Force Base in Ohio. A link to an online survey was distributed by email to members of the Society of Military Orthopaedic Surgeons. The anonymous survey polled the surgeons regarding basic demographic data and clinical practice as it pertains to the evaluation and treatment of CECS. No patient-protected health information was obtained. Survey results were compiled in a Microsoft Excel file for analysis.
Results
The survey was distributed to 606 email accounts; the response rate was 19% (114/606). Ninety-one surgeons (80%) indicated they have patients with CECS in their practice (Figure 1). Surgeons were asked how many CECS patients they see per year (responses are summarized in Figure 2) and how many years they have been in practice (Table).
Ninety-three percent of the respondents agreed or strongly agreed that ICP testing is unpleasant for the patient (Figure 3), and 90% would prefer a less-invasive test for confirmatory testing for CECS (Figure 4). Only 13% of respondents indicated they actually use noninvasive modalities (eg, MRI, NIRS) to confirm the diagnosis of CECS (Figure 5).
Respondents were asked about the practice of using ICP testing in the diagnosis of CECS (responses are summarized in Figures 6, 7). Although 85% of respondents agreed or strongly agreed with always confirming the diagnosis of CECS with ICP testing, 39% stated they would recommend surgical treatment without ICP testing if they were confident about the diagnosis based on clinical examination findings.
To better understand the apparent discrepancy between the percentage of surgeons who agreed or strongly agreed with always recommending ICP testing (85%) and the percentage who would recommend treatment without testing (39%), responses were stratified by clinical experience. Surgeons in practice more than 11 years (n = 35) were compared with those in practice 5 years or less (n = 31) (Table). Although the vast majority (85%) of respondents from both groups agreed or strongly agreed with always recommending ICP testing, 49% of those in practice more than 11 years and 29% in practice 5 years or less indicated they would recommend surgical treatment for CECS based solely on clinical examination findings (Figures 8, 9).
Responses were also stratified by number of CECS patients seen by each surgeon per year. Twenty-eight respondents saw 1 or 2 patients per year, and 12 saw more than 8 patients per year—31% and 13% of the total number of respondents, respectively. Of the respondents who saw 1 or 2 patients, 86% (24/28) agreed or strongly agreed with always recommending ICP testing—comparable to the 75% (9/12) who saw more than 8 patients (Figure 10). However, of the respondents who saw 1 or 2 patients, 36% (10/28) indicated they would recommend surgical treatment, without ICP testing, if they were confident about the clinical diagnosis of CECS—in contrast to the 75% (9/12) who saw more than 8 patients (Figure 11).
Discussion
CECS is a common cause of leg pain and a significant cause of disability among the active-duty military population. This was illustrated in 2 recent studies by Waterman and colleagues.1,9 The first1 investigated failure rates and disability after surgery for CECS among those on active duty. The authors showed that CECS is a substantial contributor to lower extremity disability in the military population and that there is a substantial risk for persistent symptoms despite surgical treatment. Nearly 1 in 5 patients experienced surgical failure after elective fasciotomy, and about 28% of patients were unable to return to the full activity required in the military. The second, more recent study9 was an epidemiologic study of risk factors associated with CECS in a physically active military population. The authors identified 4100 cases diagnosed between 2006 and 2011—representing an overall annual incidence of 0.49 per 1000 at-risk person-years, or about 683 cases per year; the authors also showed the incidence increased during the time period studied.
The diagnosis of CECS remains imperfect. A clinical history of exercise-induced lower leg pain that is relieved with rest suggests the diagnosis, but a confirmatory test is needed to distinguish CECS from other causes of exercise-induced leg pain. Although direct measurement of compartment pressures is the test used most often, it is invasive and time-consuming, can be uncomfortable for the patient, and may be associated with bleeding risk, infection, and nerve injury. Pedowitz and colleagues10 described the ICP testing criteria now generally used in the diagnosis of CECS. Unfortunately, there is little objective evidence supporting these criteria.4 Although less invasive tests (eg, MRI, NIRS) have been described,5-8 they may not be readily available across institutions, and further study is needed to validate their use in diagnosing CECS.
While an objective, validated test or measurement for confirming the diagnosis of CECS remains elusive, the outcomes after surgical treatment of CECS also remain imperfect. Surgery consists of both open and endoscopically assisted fasciotomy of the involved compartments.2,11-17 Reports of improvement after treatment range from 81% to 100%3; however, symptom relief does not come for all patients, particularly those in the military. Waterman and colleagues1 found a failure rate of about 20% among an active-duty military population. Packer and colleagues18 examined civilians with CECS, treated both operatively and nonoperatively. Patients in this series were diagnosed with CECS based on clinical symptoms as well as compartment pressure measurements according to the Pedowitz criteria. Although overall outcomes were better for operatively treated patients than for nonoperatively treated patients, only 47% of patients were completely pain-free, and 21% were unable to return to full activity.
More recent studies have explored use of other nonoperative treatment modalities. Diebal and colleagues19,20 used a running retraining program to treat patients with CECS. They based this treatment on the hypothesis that a heel-strike running pattern is associated with increased anterior compartment pressures.21 CECS patients who underwent a 6-week systematic treatment program focused on forefoot running, stride shortening, and hamstring activation during push-off experienced a decrease in clinical symptoms and posttreatment intracompartmental pressures.20 The improvements in clinical scores were maintained at 1-year follow-up. Another nonoperative intervention, recently described by Isner-Horobeti and colleagues,22 involves injecting botulinum toxin A (BoNT-A) into the anterior and lateral compartments of the leg. Sixteen patients with CECS received BoNT-A injections. On average, intracompartmental pressures were lower after injection than they were before injection. In addition, exertional pain was eliminated in 15 patients at an average follow-up of 4.4 months.
This survey-based study examined the practice patterns of military orthopedic surgeons who performed ICP testing for cases of suspected CECS. Our hypothesis was that, though ICP testing is the most commonly accepted method for confirming the diagnosis of CECS, the ICP testing rate would not be 100% among those surveyed.
The results of our study uncover an apparent inconsistency in survey responses among physicians who evaluate and treat patients with CECS. About 85% of respondents stated they would always recommend confirming the diagnosis of CECS with ICP testing. However, about 40% stated they would recommend surgical treatment without confirmatory testing if they were confident about the diagnosis based on clinical findings. In other words, only 60% of the respondents disagreed or strongly disagreed with pursuing surgical treatment without testing. One would expect a closer correlation between respondents who would always recommend ICP testing and those who disagreed with recommending surgical treatment without ICP testing. This raises the question of what actually occurs when CECS is suspected in clinical practice.
To better understand the apparent discrepancy between respondents who agreed or strongly agreed with always recommending ICP testing and respondents who would recommend treatment without testing, we grouped responses by clinical experience. Although 85% of respondents (no matter the number of years in practice) agreed or strongly agreed with the statement, “I always recommend confirming the diagnosis of CECS with ICP measurements,” 49% of those in practice more than 11 years (vs. 29% of those in practice 5 years or less) agreed or strongly agreed with recommending surgery without testing if they were 100% confident about the diagnosis of CECS based solely on clinical findings. This may suggest that, though most agreed that the gold standard for confirming the diagnosis of CECS remains ICP testing, those with more clinical experience were more comfortable forgoing this diagnostic measure and recommending treatment without testing.
Another measure of clinical experience used in this survey was based on number of CECS patients seen per year. Responses of surgeons who saw 1 or 2 patients with CECS per year were compared with responses of surgeons who saw more than 8 patients with CECS per year. Of the respondents who saw 1 or 2 patients, 86% agreed or strongly agreed with always recommending ICP testing to confirm CECS—comparable to the 75% who saw more than 8 patients. However, of the respondents who saw 1 or 2 patients, 36% indicated they would recommend surgical treatment, without ICP testing, if they were confident about the clinical diagnosis of CECS—in contrast to the 75% who saw more than 8 patients.
Responses regarding the absolute of always recommending ICP testing and the absolute of being 100% confident about the clinical diagnosis of CECS highlight differences between the surgeons with more experience (>11 years in practice, >8 CECS patients per year) and those with less experience (≤5 years in practice, 1 or 2 CECS patients per year). Surgeons in practice longer, and surgeons who saw more patients with suspected CECS per year, were more likely to recommend surgical treatment based solely on clinical findings.
Conclusion
CECS can cause debilitating activity-related leg pain in both civilian and military populations. Treatment with fasciotomy is often curative, but a significant number of patients may continue to have pain and disability. As the incidence of treatment failures may be higher in the military than in civilians, proper evaluation of patients with suspected CECS is particularly important for military orthopedic surgeons. The diagnosis of CECS can be challenging to both the clinician and patient, and diagnostic modalities remain imperfect. The results of this study highlight this, revealing less than 100% agreement regarding use of ICP testing (the gold standard) for diagnosis of CECS.
This study also highlights the need for an improved method of diagnosing CECS since 93% of respondents agreed or strongly agreed that ICP testing is unpleasant for the patient, and 90% would prefer a less-invasive test. In addition, the ICP testing criteria for establishing the diagnosis of CECS remain inconsistent. If a reliable, consistent, and less-invasive test were available, perhaps there would be less variability in practitioners’ evaluations of patients with CECS.
This study shows an inconsistency among military orthopedic surgeons evaluating and treating patients with CECS. As testing modalities for CECS remain imperfect, clinical acumen and experience assume an important role in the assessment of patients with suspected CECS.
1. Waterman BR, Laughlin M, Kilcoyne K, Cameron KL, Owens BD. Surgical treatment of chronic exertional compartment syndrome of the leg: failure rates and postoperative disability in an active patient population. J Bone Joint Surg Am. 2013;95(7):592-596.
2. Mubarak SJ, Pedowitz RA, Hargens AR. Compartment syndromes. Curr Orthop. 1989;3:36-40.
3. Fraipont MJ, Adamson GJ. Chronic exertional compartment syndrome. J Am Acad Orthop Surg. 2003;11(4):268-276.
4. Aweid O, Del Buono A, Malliaras P, et al. Systematic review and recommendations for intracompartmental pressure monitoring in diagnosing chronic exertional compartment syndrome of the leg. Clin J Sport Med. 2012;22(4):356-370.
5. Ringler MD, Litwiller DV, Felmlee JP, et al. MRI accurately detects chronic exertional compartment syndrome: a validation study. Skeletal Radiol. 2013;42(3):385-392.
6. van den Brand JG, Verleisdonk EJ, van der Werken C. Near infrared spectroscopy in the diagnosis of chronic exertional compartment syndrome. Am J Sports Med. 2004;32(2):452-456.
7. van den Brand JG, Nelson T, Verleisdonk EJ, van der Werken C. The diagnostic value of intracompartmental pressure measurement, magnetic resonance imaging, and near-infrared spectroscopy in chronic exertional compartment syndrome: a prospective study in 50 patients. Am J Sports Med. 2005;33(5):699-704.
8. Verleisdonk EJ, van Gils A, van der Werken C. The diagnostic value of MRI scans for the diagnosis of chronic exertional compartment syndrome of the lower leg. Skeletal Radiol. 2001;30(6):321-325.
9. Waterman BR, Liu J, Newcomb R, Schoenfeld AJ, Orr JD, Belmont PJ Jr. Risk factors for chronic exertional compartment syndrome in a physically active military population. Am J Sports Med. 2013;41(11):2545-2549.
10. Pedowitz RA, Hargens AR, Mubarek SJ, Gershuni DH. Modified criteria for the objective diagnosis of chronic compartment syndrome of the leg. Am J Sports Med. 1990;18(1):35-40.1. Rorabeck CH, Bourne RB, Fowler PJ. The surgical treatment of exertional compartment syndrome in athletes. J Bone Joint Surg Am. 1983;65(9):1245-1251.
12. Rorabeck CH, Fowler PJ, Nott L. The results of fasciotomy in the management of chronic exertional compartment syndrome. Am J Sports Med. 1988;16(3):224-227.
13. Detmer DE, Sharpe K, Sufit RL, Girdley FM. Chronic compartment syndrome: diagnosis, management, and outcomes. Am J Sports Med. 1985;13(3):162-170.
14. Stein DA, Sennett BJ. One-portal endoscopically assisted fasciotomy for exertional compartment syndrome. Arthroscopy. 2005;21(1):108-112.
15. Fronek J, Mubarak SJ, Hargens AR, et al. Management of chronic exertional anterior compartment syndrome of the lower extremity. Clin Orthop Relat Res. 1989;(220):217-227.
16. Leversedge FJ, Casey PJ, Seiler JG 3rd, Xerogeanes JW. Endoscopically assisted fasciotomy: description of technique and in vitro assessment of lower-leg compartment decompression. Am J Sports Med. 2002;30(2):272-278.
17. Schepsis AA, Martini D, Corbett M. Surgical management of exertional compartment syndrome of the lower leg. Long-term followup. Am J Sports Med. 1993;21(6):811-817.
18. Packer JD, Day MS, Nguyen JT, Hobart SJ, Hannafin JA, Metzl JD. Functional outcomes and patient satisfaction after fasciotomy for chronic exertional compartment syndrome. Am J Sports Med. 2013;41(2):430-436.
19. Diebal AR, Gregory R, Alitz C, Gerber JP. Effects of forefoot running on chronic exertional compartment syndrome: a case series. Int J Sports Phys Ther. 2011;6(4):312-321.
20. Diebal AR, Gregory R, Alitz C, Gerber JP. Forefoot running improves pain and disability associated with chronic exertional compartment syndrome. Am J Sports Med. 2012;40(5):1060-1067.
21. Kirby RL, McDermott AG. Anterior tibial compartment pressures during running with rearfoot and forefoot landing styles. Arch Phys Med Rehabil. 1983;64(7):296-299.
22. Isner-Horobeti ME, Dufour SP, Blaes C, Lecocq J. Intramuscular pressure before and after botulinum toxin in chronic exertional compartment syndrome of the leg: a preliminary study. Am J Sports Med. 2013;41(11):2558-2566.
Chronic exertional compartment syndrome (CECS) is a common cause of leg pain during exertion in athletic and active-duty populations.1 It is caused by an increase in intramuscular pressure to a point that the tissues within the involved compartment become ischemic because of a decrease in arteriolar blood flow.2 This relative ischemia causes pain and may also be associated with neurologic symptoms. By definition, the pain associated with CECS resolves with rest. Patients typically describe a feeling of fullness or tightness, which eventually evolves into pain as they continue exercising. Pain onset is usually predictable and reproducible after a finite amount of time and/or intensity of exercise.
The differential diagnosis of leg pain during exercise includes CECS, medial tibial stress syndrome, popliteal entrapment syndrome, myopathy, peripheral nerve entrapment syndromes, stress fracture, and effort-induced rhabdomyolysis.3 CECS can be differentiated from other causes of leg pain with measurement of compartment pressures (the standard recommendation).4 Compartment pressure measurement, however, is invasive, time-consuming, and painful and may be associated with bleeding risk, infection, and nerve injury. Noninvasive means of testing for CECS (eg, magnetic resonance imaging [MRI], near-infrared spectroscopy [NIRS], thallium stress testing) remain experimental and expensive and are not easily accessible at all institutions.5-8 While invasive compartment pressure (ICP) testing remains an important tool in the diagnosis of CECS, its criteria and execution vary considerably. Aweid and colleagues4 performed a meta-analysis of use of ICP testing in the diagnosis of CECS and concluded that, though elevated ICP measurements are accepted as the gold standard for diagnosing CECS, the criteria outlined for a positive test lack high-level supporting evidence. In addition, how the test is performed has been inconsistent across studies—further clouding the literature.4
The review by Aweid and colleagues4 highlights the deficiencies in diagnosing CECS by ICP testing. In clinical practice, ICP testing is challenging for both the patient and physician. As other validated, less-invasive tests are lacking, emphasis should remain on the history and the physical examination. Although all athletic populations are at risk for CECS, the active-duty military population is at particularly high risk because of the physical requirements and demands of military service.1,9
We surveyed military orthopedic surgeons to investigate the clinical practice of performing ICP testing in patients with suspected CECS. We hypothesized that the rate of ICP testing among military orthopedic surgeons would not be 100% for patients with the typical signs and symptoms of CECS.
Materials and Methods
This study was approved by the institutional review board at Wright-Patterson Medical Center at Wright-Patterson Air Force Base in Ohio. A link to an online survey was distributed by email to members of the Society of Military Orthopaedic Surgeons. The anonymous survey polled the surgeons regarding basic demographic data and clinical practice as it pertains to the evaluation and treatment of CECS. No patient-protected health information was obtained. Survey results were compiled in a Microsoft Excel file for analysis.
Results
The survey was distributed to 606 email accounts; the response rate was 19% (114/606). Ninety-one surgeons (80%) indicated they have patients with CECS in their practice (Figure 1). Surgeons were asked how many CECS patients they see per year (responses are summarized in Figure 2) and how many years they have been in practice (Table).
Ninety-three percent of the respondents agreed or strongly agreed that ICP testing is unpleasant for the patient (Figure 3), and 90% would prefer a less-invasive test for confirmatory testing for CECS (Figure 4). Only 13% of respondents indicated they actually use noninvasive modalities (eg, MRI, NIRS) to confirm the diagnosis of CECS (Figure 5).
Respondents were asked about the practice of using ICP testing in the diagnosis of CECS (responses are summarized in Figures 6, 7). Although 85% of respondents agreed or strongly agreed with always confirming the diagnosis of CECS with ICP testing, 39% stated they would recommend surgical treatment without ICP testing if they were confident about the diagnosis based on clinical examination findings.
To better understand the apparent discrepancy between the percentage of surgeons who agreed or strongly agreed with always recommending ICP testing (85%) and the percentage who would recommend treatment without testing (39%), responses were stratified by clinical experience. Surgeons in practice more than 11 years (n = 35) were compared with those in practice 5 years or less (n = 31) (Table). Although the vast majority (85%) of respondents from both groups agreed or strongly agreed with always recommending ICP testing, 49% of those in practice more than 11 years and 29% in practice 5 years or less indicated they would recommend surgical treatment for CECS based solely on clinical examination findings (Figures 8, 9).
Responses were also stratified by number of CECS patients seen by each surgeon per year. Twenty-eight respondents saw 1 or 2 patients per year, and 12 saw more than 8 patients per year—31% and 13% of the total number of respondents, respectively. Of the respondents who saw 1 or 2 patients, 86% (24/28) agreed or strongly agreed with always recommending ICP testing—comparable to the 75% (9/12) who saw more than 8 patients (Figure 10). However, of the respondents who saw 1 or 2 patients, 36% (10/28) indicated they would recommend surgical treatment, without ICP testing, if they were confident about the clinical diagnosis of CECS—in contrast to the 75% (9/12) who saw more than 8 patients (Figure 11).
Discussion
CECS is a common cause of leg pain and a significant cause of disability among the active-duty military population. This was illustrated in 2 recent studies by Waterman and colleagues.1,9 The first1 investigated failure rates and disability after surgery for CECS among those on active duty. The authors showed that CECS is a substantial contributor to lower extremity disability in the military population and that there is a substantial risk for persistent symptoms despite surgical treatment. Nearly 1 in 5 patients experienced surgical failure after elective fasciotomy, and about 28% of patients were unable to return to the full activity required in the military. The second, more recent study9 was an epidemiologic study of risk factors associated with CECS in a physically active military population. The authors identified 4100 cases diagnosed between 2006 and 2011—representing an overall annual incidence of 0.49 per 1000 at-risk person-years, or about 683 cases per year; the authors also showed the incidence increased during the time period studied.
The diagnosis of CECS remains imperfect. A clinical history of exercise-induced lower leg pain that is relieved with rest suggests the diagnosis, but a confirmatory test is needed to distinguish CECS from other causes of exercise-induced leg pain. Although direct measurement of compartment pressures is the test used most often, it is invasive and time-consuming, can be uncomfortable for the patient, and may be associated with bleeding risk, infection, and nerve injury. Pedowitz and colleagues10 described the ICP testing criteria now generally used in the diagnosis of CECS. Unfortunately, there is little objective evidence supporting these criteria.4 Although less invasive tests (eg, MRI, NIRS) have been described,5-8 they may not be readily available across institutions, and further study is needed to validate their use in diagnosing CECS.
While an objective, validated test or measurement for confirming the diagnosis of CECS remains elusive, the outcomes after surgical treatment of CECS also remain imperfect. Surgery consists of both open and endoscopically assisted fasciotomy of the involved compartments.2,11-17 Reports of improvement after treatment range from 81% to 100%3; however, symptom relief does not come for all patients, particularly those in the military. Waterman and colleagues1 found a failure rate of about 20% among an active-duty military population. Packer and colleagues18 examined civilians with CECS, treated both operatively and nonoperatively. Patients in this series were diagnosed with CECS based on clinical symptoms as well as compartment pressure measurements according to the Pedowitz criteria. Although overall outcomes were better for operatively treated patients than for nonoperatively treated patients, only 47% of patients were completely pain-free, and 21% were unable to return to full activity.
More recent studies have explored use of other nonoperative treatment modalities. Diebal and colleagues19,20 used a running retraining program to treat patients with CECS. They based this treatment on the hypothesis that a heel-strike running pattern is associated with increased anterior compartment pressures.21 CECS patients who underwent a 6-week systematic treatment program focused on forefoot running, stride shortening, and hamstring activation during push-off experienced a decrease in clinical symptoms and posttreatment intracompartmental pressures.20 The improvements in clinical scores were maintained at 1-year follow-up. Another nonoperative intervention, recently described by Isner-Horobeti and colleagues,22 involves injecting botulinum toxin A (BoNT-A) into the anterior and lateral compartments of the leg. Sixteen patients with CECS received BoNT-A injections. On average, intracompartmental pressures were lower after injection than they were before injection. In addition, exertional pain was eliminated in 15 patients at an average follow-up of 4.4 months.
This survey-based study examined the practice patterns of military orthopedic surgeons who performed ICP testing for cases of suspected CECS. Our hypothesis was that, though ICP testing is the most commonly accepted method for confirming the diagnosis of CECS, the ICP testing rate would not be 100% among those surveyed.
The results of our study uncover an apparent inconsistency in survey responses among physicians who evaluate and treat patients with CECS. About 85% of respondents stated they would always recommend confirming the diagnosis of CECS with ICP testing. However, about 40% stated they would recommend surgical treatment without confirmatory testing if they were confident about the diagnosis based on clinical findings. In other words, only 60% of the respondents disagreed or strongly disagreed with pursuing surgical treatment without testing. One would expect a closer correlation between respondents who would always recommend ICP testing and those who disagreed with recommending surgical treatment without ICP testing. This raises the question of what actually occurs when CECS is suspected in clinical practice.
To better understand the apparent discrepancy between respondents who agreed or strongly agreed with always recommending ICP testing and respondents who would recommend treatment without testing, we grouped responses by clinical experience. Although 85% of respondents (no matter the number of years in practice) agreed or strongly agreed with the statement, “I always recommend confirming the diagnosis of CECS with ICP measurements,” 49% of those in practice more than 11 years (vs. 29% of those in practice 5 years or less) agreed or strongly agreed with recommending surgery without testing if they were 100% confident about the diagnosis of CECS based solely on clinical findings. This may suggest that, though most agreed that the gold standard for confirming the diagnosis of CECS remains ICP testing, those with more clinical experience were more comfortable forgoing this diagnostic measure and recommending treatment without testing.
Another measure of clinical experience used in this survey was based on number of CECS patients seen per year. Responses of surgeons who saw 1 or 2 patients with CECS per year were compared with responses of surgeons who saw more than 8 patients with CECS per year. Of the respondents who saw 1 or 2 patients, 86% agreed or strongly agreed with always recommending ICP testing to confirm CECS—comparable to the 75% who saw more than 8 patients. However, of the respondents who saw 1 or 2 patients, 36% indicated they would recommend surgical treatment, without ICP testing, if they were confident about the clinical diagnosis of CECS—in contrast to the 75% who saw more than 8 patients.
Responses regarding the absolute of always recommending ICP testing and the absolute of being 100% confident about the clinical diagnosis of CECS highlight differences between the surgeons with more experience (>11 years in practice, >8 CECS patients per year) and those with less experience (≤5 years in practice, 1 or 2 CECS patients per year). Surgeons in practice longer, and surgeons who saw more patients with suspected CECS per year, were more likely to recommend surgical treatment based solely on clinical findings.
Conclusion
CECS can cause debilitating activity-related leg pain in both civilian and military populations. Treatment with fasciotomy is often curative, but a significant number of patients may continue to have pain and disability. As the incidence of treatment failures may be higher in the military than in civilians, proper evaluation of patients with suspected CECS is particularly important for military orthopedic surgeons. The diagnosis of CECS can be challenging to both the clinician and patient, and diagnostic modalities remain imperfect. The results of this study highlight this, revealing less than 100% agreement regarding use of ICP testing (the gold standard) for diagnosis of CECS.
This study also highlights the need for an improved method of diagnosing CECS since 93% of respondents agreed or strongly agreed that ICP testing is unpleasant for the patient, and 90% would prefer a less-invasive test. In addition, the ICP testing criteria for establishing the diagnosis of CECS remain inconsistent. If a reliable, consistent, and less-invasive test were available, perhaps there would be less variability in practitioners’ evaluations of patients with CECS.
This study shows an inconsistency among military orthopedic surgeons evaluating and treating patients with CECS. As testing modalities for CECS remain imperfect, clinical acumen and experience assume an important role in the assessment of patients with suspected CECS.
Chronic exertional compartment syndrome (CECS) is a common cause of leg pain during exertion in athletic and active-duty populations.1 It is caused by an increase in intramuscular pressure to a point that the tissues within the involved compartment become ischemic because of a decrease in arteriolar blood flow.2 This relative ischemia causes pain and may also be associated with neurologic symptoms. By definition, the pain associated with CECS resolves with rest. Patients typically describe a feeling of fullness or tightness, which eventually evolves into pain as they continue exercising. Pain onset is usually predictable and reproducible after a finite amount of time and/or intensity of exercise.
The differential diagnosis of leg pain during exercise includes CECS, medial tibial stress syndrome, popliteal entrapment syndrome, myopathy, peripheral nerve entrapment syndromes, stress fracture, and effort-induced rhabdomyolysis.3 CECS can be differentiated from other causes of leg pain with measurement of compartment pressures (the standard recommendation).4 Compartment pressure measurement, however, is invasive, time-consuming, and painful and may be associated with bleeding risk, infection, and nerve injury. Noninvasive means of testing for CECS (eg, magnetic resonance imaging [MRI], near-infrared spectroscopy [NIRS], thallium stress testing) remain experimental and expensive and are not easily accessible at all institutions.5-8 While invasive compartment pressure (ICP) testing remains an important tool in the diagnosis of CECS, its criteria and execution vary considerably. Aweid and colleagues4 performed a meta-analysis of use of ICP testing in the diagnosis of CECS and concluded that, though elevated ICP measurements are accepted as the gold standard for diagnosing CECS, the criteria outlined for a positive test lack high-level supporting evidence. In addition, how the test is performed has been inconsistent across studies—further clouding the literature.4
The review by Aweid and colleagues4 highlights the deficiencies in diagnosing CECS by ICP testing. In clinical practice, ICP testing is challenging for both the patient and physician. As other validated, less-invasive tests are lacking, emphasis should remain on the history and the physical examination. Although all athletic populations are at risk for CECS, the active-duty military population is at particularly high risk because of the physical requirements and demands of military service.1,9
We surveyed military orthopedic surgeons to investigate the clinical practice of performing ICP testing in patients with suspected CECS. We hypothesized that the rate of ICP testing among military orthopedic surgeons would not be 100% for patients with the typical signs and symptoms of CECS.
Materials and Methods
This study was approved by the institutional review board at Wright-Patterson Medical Center at Wright-Patterson Air Force Base in Ohio. A link to an online survey was distributed by email to members of the Society of Military Orthopaedic Surgeons. The anonymous survey polled the surgeons regarding basic demographic data and clinical practice as it pertains to the evaluation and treatment of CECS. No patient-protected health information was obtained. Survey results were compiled in a Microsoft Excel file for analysis.
Results
The survey was distributed to 606 email accounts; the response rate was 19% (114/606). Ninety-one surgeons (80%) indicated they have patients with CECS in their practice (Figure 1). Surgeons were asked how many CECS patients they see per year (responses are summarized in Figure 2) and how many years they have been in practice (Table).
Ninety-three percent of the respondents agreed or strongly agreed that ICP testing is unpleasant for the patient (Figure 3), and 90% would prefer a less-invasive test for confirmatory testing for CECS (Figure 4). Only 13% of respondents indicated they actually use noninvasive modalities (eg, MRI, NIRS) to confirm the diagnosis of CECS (Figure 5).
Respondents were asked about the practice of using ICP testing in the diagnosis of CECS (responses are summarized in Figures 6, 7). Although 85% of respondents agreed or strongly agreed with always confirming the diagnosis of CECS with ICP testing, 39% stated they would recommend surgical treatment without ICP testing if they were confident about the diagnosis based on clinical examination findings.
To better understand the apparent discrepancy between the percentage of surgeons who agreed or strongly agreed with always recommending ICP testing (85%) and the percentage who would recommend treatment without testing (39%), responses were stratified by clinical experience. Surgeons in practice more than 11 years (n = 35) were compared with those in practice 5 years or less (n = 31) (Table). Although the vast majority (85%) of respondents from both groups agreed or strongly agreed with always recommending ICP testing, 49% of those in practice more than 11 years and 29% in practice 5 years or less indicated they would recommend surgical treatment for CECS based solely on clinical examination findings (Figures 8, 9).
Responses were also stratified by number of CECS patients seen by each surgeon per year. Twenty-eight respondents saw 1 or 2 patients per year, and 12 saw more than 8 patients per year—31% and 13% of the total number of respondents, respectively. Of the respondents who saw 1 or 2 patients, 86% (24/28) agreed or strongly agreed with always recommending ICP testing—comparable to the 75% (9/12) who saw more than 8 patients (Figure 10). However, of the respondents who saw 1 or 2 patients, 36% (10/28) indicated they would recommend surgical treatment, without ICP testing, if they were confident about the clinical diagnosis of CECS—in contrast to the 75% (9/12) who saw more than 8 patients (Figure 11).
Discussion
CECS is a common cause of leg pain and a significant cause of disability among the active-duty military population. This was illustrated in 2 recent studies by Waterman and colleagues.1,9 The first1 investigated failure rates and disability after surgery for CECS among those on active duty. The authors showed that CECS is a substantial contributor to lower extremity disability in the military population and that there is a substantial risk for persistent symptoms despite surgical treatment. Nearly 1 in 5 patients experienced surgical failure after elective fasciotomy, and about 28% of patients were unable to return to the full activity required in the military. The second, more recent study9 was an epidemiologic study of risk factors associated with CECS in a physically active military population. The authors identified 4100 cases diagnosed between 2006 and 2011—representing an overall annual incidence of 0.49 per 1000 at-risk person-years, or about 683 cases per year; the authors also showed the incidence increased during the time period studied.
The diagnosis of CECS remains imperfect. A clinical history of exercise-induced lower leg pain that is relieved with rest suggests the diagnosis, but a confirmatory test is needed to distinguish CECS from other causes of exercise-induced leg pain. Although direct measurement of compartment pressures is the test used most often, it is invasive and time-consuming, can be uncomfortable for the patient, and may be associated with bleeding risk, infection, and nerve injury. Pedowitz and colleagues10 described the ICP testing criteria now generally used in the diagnosis of CECS. Unfortunately, there is little objective evidence supporting these criteria.4 Although less invasive tests (eg, MRI, NIRS) have been described,5-8 they may not be readily available across institutions, and further study is needed to validate their use in diagnosing CECS.
While an objective, validated test or measurement for confirming the diagnosis of CECS remains elusive, the outcomes after surgical treatment of CECS also remain imperfect. Surgery consists of both open and endoscopically assisted fasciotomy of the involved compartments.2,11-17 Reports of improvement after treatment range from 81% to 100%3; however, symptom relief does not come for all patients, particularly those in the military. Waterman and colleagues1 found a failure rate of about 20% among an active-duty military population. Packer and colleagues18 examined civilians with CECS, treated both operatively and nonoperatively. Patients in this series were diagnosed with CECS based on clinical symptoms as well as compartment pressure measurements according to the Pedowitz criteria. Although overall outcomes were better for operatively treated patients than for nonoperatively treated patients, only 47% of patients were completely pain-free, and 21% were unable to return to full activity.
More recent studies have explored use of other nonoperative treatment modalities. Diebal and colleagues19,20 used a running retraining program to treat patients with CECS. They based this treatment on the hypothesis that a heel-strike running pattern is associated with increased anterior compartment pressures.21 CECS patients who underwent a 6-week systematic treatment program focused on forefoot running, stride shortening, and hamstring activation during push-off experienced a decrease in clinical symptoms and posttreatment intracompartmental pressures.20 The improvements in clinical scores were maintained at 1-year follow-up. Another nonoperative intervention, recently described by Isner-Horobeti and colleagues,22 involves injecting botulinum toxin A (BoNT-A) into the anterior and lateral compartments of the leg. Sixteen patients with CECS received BoNT-A injections. On average, intracompartmental pressures were lower after injection than they were before injection. In addition, exertional pain was eliminated in 15 patients at an average follow-up of 4.4 months.
This survey-based study examined the practice patterns of military orthopedic surgeons who performed ICP testing for cases of suspected CECS. Our hypothesis was that, though ICP testing is the most commonly accepted method for confirming the diagnosis of CECS, the ICP testing rate would not be 100% among those surveyed.
The results of our study uncover an apparent inconsistency in survey responses among physicians who evaluate and treat patients with CECS. About 85% of respondents stated they would always recommend confirming the diagnosis of CECS with ICP testing. However, about 40% stated they would recommend surgical treatment without confirmatory testing if they were confident about the diagnosis based on clinical findings. In other words, only 60% of the respondents disagreed or strongly disagreed with pursuing surgical treatment without testing. One would expect a closer correlation between respondents who would always recommend ICP testing and those who disagreed with recommending surgical treatment without ICP testing. This raises the question of what actually occurs when CECS is suspected in clinical practice.
To better understand the apparent discrepancy between respondents who agreed or strongly agreed with always recommending ICP testing and respondents who would recommend treatment without testing, we grouped responses by clinical experience. Although 85% of respondents (no matter the number of years in practice) agreed or strongly agreed with the statement, “I always recommend confirming the diagnosis of CECS with ICP measurements,” 49% of those in practice more than 11 years (vs. 29% of those in practice 5 years or less) agreed or strongly agreed with recommending surgery without testing if they were 100% confident about the diagnosis of CECS based solely on clinical findings. This may suggest that, though most agreed that the gold standard for confirming the diagnosis of CECS remains ICP testing, those with more clinical experience were more comfortable forgoing this diagnostic measure and recommending treatment without testing.
Another measure of clinical experience used in this survey was based on number of CECS patients seen per year. Responses of surgeons who saw 1 or 2 patients with CECS per year were compared with responses of surgeons who saw more than 8 patients with CECS per year. Of the respondents who saw 1 or 2 patients, 86% agreed or strongly agreed with always recommending ICP testing to confirm CECS—comparable to the 75% who saw more than 8 patients. However, of the respondents who saw 1 or 2 patients, 36% indicated they would recommend surgical treatment, without ICP testing, if they were confident about the clinical diagnosis of CECS—in contrast to the 75% who saw more than 8 patients.
Responses regarding the absolute of always recommending ICP testing and the absolute of being 100% confident about the clinical diagnosis of CECS highlight differences between the surgeons with more experience (>11 years in practice, >8 CECS patients per year) and those with less experience (≤5 years in practice, 1 or 2 CECS patients per year). Surgeons in practice longer, and surgeons who saw more patients with suspected CECS per year, were more likely to recommend surgical treatment based solely on clinical findings.
Conclusion
CECS can cause debilitating activity-related leg pain in both civilian and military populations. Treatment with fasciotomy is often curative, but a significant number of patients may continue to have pain and disability. As the incidence of treatment failures may be higher in the military than in civilians, proper evaluation of patients with suspected CECS is particularly important for military orthopedic surgeons. The diagnosis of CECS can be challenging to both the clinician and patient, and diagnostic modalities remain imperfect. The results of this study highlight this, revealing less than 100% agreement regarding use of ICP testing (the gold standard) for diagnosis of CECS.
This study also highlights the need for an improved method of diagnosing CECS since 93% of respondents agreed or strongly agreed that ICP testing is unpleasant for the patient, and 90% would prefer a less-invasive test. In addition, the ICP testing criteria for establishing the diagnosis of CECS remain inconsistent. If a reliable, consistent, and less-invasive test were available, perhaps there would be less variability in practitioners’ evaluations of patients with CECS.
This study shows an inconsistency among military orthopedic surgeons evaluating and treating patients with CECS. As testing modalities for CECS remain imperfect, clinical acumen and experience assume an important role in the assessment of patients with suspected CECS.
1. Waterman BR, Laughlin M, Kilcoyne K, Cameron KL, Owens BD. Surgical treatment of chronic exertional compartment syndrome of the leg: failure rates and postoperative disability in an active patient population. J Bone Joint Surg Am. 2013;95(7):592-596.
2. Mubarak SJ, Pedowitz RA, Hargens AR. Compartment syndromes. Curr Orthop. 1989;3:36-40.
3. Fraipont MJ, Adamson GJ. Chronic exertional compartment syndrome. J Am Acad Orthop Surg. 2003;11(4):268-276.
4. Aweid O, Del Buono A, Malliaras P, et al. Systematic review and recommendations for intracompartmental pressure monitoring in diagnosing chronic exertional compartment syndrome of the leg. Clin J Sport Med. 2012;22(4):356-370.
5. Ringler MD, Litwiller DV, Felmlee JP, et al. MRI accurately detects chronic exertional compartment syndrome: a validation study. Skeletal Radiol. 2013;42(3):385-392.
6. van den Brand JG, Verleisdonk EJ, van der Werken C. Near infrared spectroscopy in the diagnosis of chronic exertional compartment syndrome. Am J Sports Med. 2004;32(2):452-456.
7. van den Brand JG, Nelson T, Verleisdonk EJ, van der Werken C. The diagnostic value of intracompartmental pressure measurement, magnetic resonance imaging, and near-infrared spectroscopy in chronic exertional compartment syndrome: a prospective study in 50 patients. Am J Sports Med. 2005;33(5):699-704.
8. Verleisdonk EJ, van Gils A, van der Werken C. The diagnostic value of MRI scans for the diagnosis of chronic exertional compartment syndrome of the lower leg. Skeletal Radiol. 2001;30(6):321-325.
9. Waterman BR, Liu J, Newcomb R, Schoenfeld AJ, Orr JD, Belmont PJ Jr. Risk factors for chronic exertional compartment syndrome in a physically active military population. Am J Sports Med. 2013;41(11):2545-2549.
10. Pedowitz RA, Hargens AR, Mubarek SJ, Gershuni DH. Modified criteria for the objective diagnosis of chronic compartment syndrome of the leg. Am J Sports Med. 1990;18(1):35-40.1. Rorabeck CH, Bourne RB, Fowler PJ. The surgical treatment of exertional compartment syndrome in athletes. J Bone Joint Surg Am. 1983;65(9):1245-1251.
12. Rorabeck CH, Fowler PJ, Nott L. The results of fasciotomy in the management of chronic exertional compartment syndrome. Am J Sports Med. 1988;16(3):224-227.
13. Detmer DE, Sharpe K, Sufit RL, Girdley FM. Chronic compartment syndrome: diagnosis, management, and outcomes. Am J Sports Med. 1985;13(3):162-170.
14. Stein DA, Sennett BJ. One-portal endoscopically assisted fasciotomy for exertional compartment syndrome. Arthroscopy. 2005;21(1):108-112.
15. Fronek J, Mubarak SJ, Hargens AR, et al. Management of chronic exertional anterior compartment syndrome of the lower extremity. Clin Orthop Relat Res. 1989;(220):217-227.
16. Leversedge FJ, Casey PJ, Seiler JG 3rd, Xerogeanes JW. Endoscopically assisted fasciotomy: description of technique and in vitro assessment of lower-leg compartment decompression. Am J Sports Med. 2002;30(2):272-278.
17. Schepsis AA, Martini D, Corbett M. Surgical management of exertional compartment syndrome of the lower leg. Long-term followup. Am J Sports Med. 1993;21(6):811-817.
18. Packer JD, Day MS, Nguyen JT, Hobart SJ, Hannafin JA, Metzl JD. Functional outcomes and patient satisfaction after fasciotomy for chronic exertional compartment syndrome. Am J Sports Med. 2013;41(2):430-436.
19. Diebal AR, Gregory R, Alitz C, Gerber JP. Effects of forefoot running on chronic exertional compartment syndrome: a case series. Int J Sports Phys Ther. 2011;6(4):312-321.
20. Diebal AR, Gregory R, Alitz C, Gerber JP. Forefoot running improves pain and disability associated with chronic exertional compartment syndrome. Am J Sports Med. 2012;40(5):1060-1067.
21. Kirby RL, McDermott AG. Anterior tibial compartment pressures during running with rearfoot and forefoot landing styles. Arch Phys Med Rehabil. 1983;64(7):296-299.
22. Isner-Horobeti ME, Dufour SP, Blaes C, Lecocq J. Intramuscular pressure before and after botulinum toxin in chronic exertional compartment syndrome of the leg: a preliminary study. Am J Sports Med. 2013;41(11):2558-2566.
1. Waterman BR, Laughlin M, Kilcoyne K, Cameron KL, Owens BD. Surgical treatment of chronic exertional compartment syndrome of the leg: failure rates and postoperative disability in an active patient population. J Bone Joint Surg Am. 2013;95(7):592-596.
2. Mubarak SJ, Pedowitz RA, Hargens AR. Compartment syndromes. Curr Orthop. 1989;3:36-40.
3. Fraipont MJ, Adamson GJ. Chronic exertional compartment syndrome. J Am Acad Orthop Surg. 2003;11(4):268-276.
4. Aweid O, Del Buono A, Malliaras P, et al. Systematic review and recommendations for intracompartmental pressure monitoring in diagnosing chronic exertional compartment syndrome of the leg. Clin J Sport Med. 2012;22(4):356-370.
5. Ringler MD, Litwiller DV, Felmlee JP, et al. MRI accurately detects chronic exertional compartment syndrome: a validation study. Skeletal Radiol. 2013;42(3):385-392.
6. van den Brand JG, Verleisdonk EJ, van der Werken C. Near infrared spectroscopy in the diagnosis of chronic exertional compartment syndrome. Am J Sports Med. 2004;32(2):452-456.
7. van den Brand JG, Nelson T, Verleisdonk EJ, van der Werken C. The diagnostic value of intracompartmental pressure measurement, magnetic resonance imaging, and near-infrared spectroscopy in chronic exertional compartment syndrome: a prospective study in 50 patients. Am J Sports Med. 2005;33(5):699-704.
8. Verleisdonk EJ, van Gils A, van der Werken C. The diagnostic value of MRI scans for the diagnosis of chronic exertional compartment syndrome of the lower leg. Skeletal Radiol. 2001;30(6):321-325.
9. Waterman BR, Liu J, Newcomb R, Schoenfeld AJ, Orr JD, Belmont PJ Jr. Risk factors for chronic exertional compartment syndrome in a physically active military population. Am J Sports Med. 2013;41(11):2545-2549.
10. Pedowitz RA, Hargens AR, Mubarek SJ, Gershuni DH. Modified criteria for the objective diagnosis of chronic compartment syndrome of the leg. Am J Sports Med. 1990;18(1):35-40.1. Rorabeck CH, Bourne RB, Fowler PJ. The surgical treatment of exertional compartment syndrome in athletes. J Bone Joint Surg Am. 1983;65(9):1245-1251.
12. Rorabeck CH, Fowler PJ, Nott L. The results of fasciotomy in the management of chronic exertional compartment syndrome. Am J Sports Med. 1988;16(3):224-227.
13. Detmer DE, Sharpe K, Sufit RL, Girdley FM. Chronic compartment syndrome: diagnosis, management, and outcomes. Am J Sports Med. 1985;13(3):162-170.
14. Stein DA, Sennett BJ. One-portal endoscopically assisted fasciotomy for exertional compartment syndrome. Arthroscopy. 2005;21(1):108-112.
15. Fronek J, Mubarak SJ, Hargens AR, et al. Management of chronic exertional anterior compartment syndrome of the lower extremity. Clin Orthop Relat Res. 1989;(220):217-227.
16. Leversedge FJ, Casey PJ, Seiler JG 3rd, Xerogeanes JW. Endoscopically assisted fasciotomy: description of technique and in vitro assessment of lower-leg compartment decompression. Am J Sports Med. 2002;30(2):272-278.
17. Schepsis AA, Martini D, Corbett M. Surgical management of exertional compartment syndrome of the lower leg. Long-term followup. Am J Sports Med. 1993;21(6):811-817.
18. Packer JD, Day MS, Nguyen JT, Hobart SJ, Hannafin JA, Metzl JD. Functional outcomes and patient satisfaction after fasciotomy for chronic exertional compartment syndrome. Am J Sports Med. 2013;41(2):430-436.
19. Diebal AR, Gregory R, Alitz C, Gerber JP. Effects of forefoot running on chronic exertional compartment syndrome: a case series. Int J Sports Phys Ther. 2011;6(4):312-321.
20. Diebal AR, Gregory R, Alitz C, Gerber JP. Forefoot running improves pain and disability associated with chronic exertional compartment syndrome. Am J Sports Med. 2012;40(5):1060-1067.
21. Kirby RL, McDermott AG. Anterior tibial compartment pressures during running with rearfoot and forefoot landing styles. Arch Phys Med Rehabil. 1983;64(7):296-299.
22. Isner-Horobeti ME, Dufour SP, Blaes C, Lecocq J. Intramuscular pressure before and after botulinum toxin in chronic exertional compartment syndrome of the leg: a preliminary study. Am J Sports Med. 2013;41(11):2558-2566.
Characteristics Associated With Active Defects in Juvenile Spondylolysis
Spondylolysis, a defect in the pars interarticularis, is the single most common identifiable source of persistent low back pain in adolescent athletes.1,2 The diagnosis of spondylolysis is confirmed by radiographic imaging.3 However, there is controversy regarding which imaging modality is preferred—specifically, which to use for first-line advanced imaging after plain radiographs are obtained.3 Single-photon emission computed tomography (SPECT) consistently has been shown to be the most sensitive modality, and it is considered the gold standard.4-7 Patients with a positive SPECT scan are then routinely imaged with computed tomography (CT) for bone detail and staging of the pars defect.8 This imaging or diagnostic sequence yields organ-specific radiation doses (15-30 mSv) as much as 50-fold higher than those of plain radiography.9 Recent epidemiologic studies have shown that this organ dose results in an increased risk of cancer, especially in children.10
Diagnosis is crucial in early-stage lumbar spondylolysis, as osseous healing can occur with conservative treatment.11,12 High signal change (HSC) in the pedicle or pars interarticularis (Figure 1) on fluid-specific (T2) magnetic resonance imaging (MRI) sequences has been shown to be important in the diagnosis of early spondylolysis and, subsequently, a good predictor of bony healing.13,14 We conducted a study to determine the clinical and radiographic characteristics associated with the diagnosis of early or active spondylolysis.
Materials and Methods
The study was reviewed and approved by the local institutional review board. Using the International Classification of Diseases, Ninth Revision (ICD-9) diagnosis code for spondylolysis (756.11), we retrospectively identified patients (age, 12-21 years) from 2002–2011 billing data from a single specialty spine practice. Baseline data—including height, weight, sex, age, symptom duration, sporting activities, defect location, pain score, and previous treatments—were collected from a standardized patient intake questionnaire and office medical records. We also determined radiographic data, including level, laterality (right vs left, unilateral vs bilateral), presence of listhesis, and slip grade and percentage. CT scans were reviewed to confirm the spondylolysis diagnosis and to measure parameters described by Fujii and colleagues.15 These parameters include spondylolysis chronicity (early, progressive, terminal) (Figure 2), distance from defect to posterior margin of vertebral body, and defect angle relative to posterior margin of vertebral body. We also measured sagittal radiographic parameters, including pelvic incidence and lumbar lordosis.
Pars lesions were divided into active and inactive defects16 based on signal characteristics on either MRI or SPECT (Figure 3). Defects with a positive SPECT or HSC on T2 MRI were classified as active; all other defects were classified as inactive. All MRIs were reviewed by a radiologist, and any mention of HSC in the pedicle or pars of the corresponding level was considered positive. For the sake of accuracy, all MRIs were also reviewed by a spine surgeon. All CT measurements were done by 1 of 2 authors. Demographic, clinical, and radiographic characteristics were compared between patients with active defects and patients with inactive defects. Independent t tests and Fisher exact tests were used to compare continuous and categorical variables, respectively. Threshold P was set at .01 to account for the small sample size and multiple concurrent comparisons.
Results
Fifty-seven patients (29 males, 28 females) with a total of 108 pars defects (6 unilateral, 102 bilateral) were identified. Mean age was 14.64 years. Of the 108 defects, 49 were classified as active and 59 as inactive. SPECT results were available for 52 defects, MRI results for 85, and CT results for 76 (Table 1). There was no difference between the active and inactive groups in age (14.7 vs 14.6 years; P = .083), body mass index (24.2 vs 21.7 kg/m2; P = .034), symptom duration (236.3 vs 397.4 days; P = .016), lumbar lordosis (27.4° vs 32.1°; P = .097), pelvic incidence (59.0° vs 61.2°; P = .488), slip percentage (9.5% vs 14.2%; P = .034), and laterality (right vs left, P = .847; unilateral vs bilateral, P = .281) (Table 2). There was a significant difference between the active and inactive groups in sex (35 vs 19 males; P < .0001) and presence of listhesis (16 vs 35; P = .006) (Table 2).
Of the 49 active defects, 3 were graded as early, 10 as progressive, and 11 as terminal (Table 3). There was a statistically significant (P < .0001) difference between active and inactive lesions for each stage. Mean distance from posterior margin of the vertebral body was 0.57 mm and 0.68 mm for inactive and active lesions, respectively (P = .007). There was no significant difference (P = .294) in the posterior angle of the vertebral body and the defect between inactive (20.54°) and active (24.73°) lesions (Table 3).
Subanalysis by sex showed no difference in age (males, 16.4 years vs females, 18.7 years; P = .073), slip percentage (10.4% vs 13.4%; P = .168), or presence or absence of slip (25 vs 26; P > .99) (Table 4).
Discussion
Increasing MRI resolution combined with increasing concern about unnecessary radiation exposure has added to the attractiveness of MRI in the diagnosis of spondylolysis. Spondylolysis progresses on a continuum, starting with a stress reaction (early or active defect) and ending with either healing or nonunion of the pars defect (terminal defect) (Figure 4). Although risk factors for progression are not clearly defined, Fujii and colleagues15 showed that the reaction around the defect is the most important factor for osseous union. It would then make sense that the earlier the spondylolytic defect is identified, the higher the likelihood for union, especially with nonoperative treatment such as rest, activity restriction, and bracing.12,17
There is a lack of consensus regarding MRI use in the diagnosis of spondylolysis. Masci and colleagues18 prospectively evaluated 50 defects in 39 patients using a 1.5-Tesla MRI scanner, concluded MRI is inferior to SPECT/CT, and recommended that SPECT remain the first-line advanced imaging modality. Conversely, Campbell and colleagues4 prospectively evaluated 40 defects in 22 patients using a 1.0-Tesla magnet and concluded that MRI can be used as an effective and reliable first-line advanced imaging modality. These are the only 2 prospective studies conducted within the past decade. Both were underpowered and used outdated technology (newer MRI scanners use 3.0-Tesla magnets). In addition, specific imaging characteristics (eg, edema in pars or pedicle on fluid-specific sequences) that suggest a positive finding—versus overt fracture on T1 MRI—have been recently emphasized. Neither Masci and colleagues18 nor Campbell and colleagues4 detailed what constituted a positive MRI finding. Although an adequately powered prospective study will provide a better analysis of the utility of MRI versus SPECT, such a study is costly and time-consuming. It is important to identify patient and lesion characteristics to help optimize the usefulness of MRI. It is also important to identify the subset of patients most likely to experience osseous healing of active defects,16 as this is the same subset of patients most likely to respond to nonoperative treatment.
We conducted the present study to identify any clinical or radiographic characteristics associated with the diagnosis of early or active spondylolysis. Almost equal numbers of active and inactive defects (49, 59) were identified. There were no differences in patient characteristics, including age, body mass index, and symptom duration. However, there was a significant sex difference—a relatively high proportion of males with active spondylolysis. This finding, which had been reported before,16,19,20 is probably the result of several factors, including males’ lower lumbar spine bone mineral density21; their relatively less spinal flexibility, which affects the distribution of torsional loads on the spine22; and their relatively greater participation in sports, especially sports involving high-velocity, torsional loading of the lumbar spine.23 Studies are needed to delineate the extent to which sex influences the development and persistence of active spondylolytic lesions. Alternatively, a subanalysis revealed an age difference, between our female and male cohorts (18.7 vs 16.4 years), that may have contributed to the high proportion of males with active spondylolysis.
Although the groups’ difference in symptom duration was not significant, it was trending toward significance. As discussed, it could be explained that, along the continuum of disease, earlier defects are more active and either achieve fibrous or osseous union or become chronic and “burn out” to inactive lesions, potentially leading to a listhesis.24 The listhesis association was higher in the inactive group than in the active group (P = .006). The difference in numbers of active and inactive defects at each stage (early, progressive, late) confirms this finding, with no inactive lesions in the early and progressive stages and many fewer active lesions in the terminal stage. Overall, presence of a spondylolisthesis on plain radiographs may obviate the need for SPECT or MRI, as it indicates an inactive chronic lesion—unless new symptoms are suspicious for reactivation or development of previously described adjacent-level pars defects.
No other radiographic parameters were found to be significant—consistent with findings of other studies.2,5,16 Pelvic incidence has been shown to predict progression of spondylisthesis, but under our study parameters it appears not to be associated with development of a slip.
This study had several weaknesses. First, it was retrospective, and imaging parameters were inconsistent, as we included patients who underwent imaging at other facilities. Second, the timing of imaging was inconsistent. Ideally, the same sequence protocol would be used, and all imaging studies (MRI, SPECT, CT) would be performed within a specific period after the initial concern for a spondylolysis was raised. Last, not all patients underwent all 3 advanced imaging modalities; having all 3 would have allowed for a retrospective comparison of MRI and SPECT sensitivity in detecting spondylolysis. Such a comparison would have been interesting, though it was not the goal of this study.
With its technological improvements and lack of radiation exposure, MRI is becoming more attractive as a first-line advanced imaging modality. Although the superiority of MRI over SPECT is yet to be confirmed, clinical use of MRI in the evaluation of spondylolysis seems to be increasing. It is therefore important to characterize the spondylolytic defects that are readily detected with MRI.
Active or early juvenile spondylolysis appears to be associated with males and absence of an associated listhesis. These clinical and radiographic characteristics may be important in the identification of patients with higher potential for osseous healing after nonoperative treatment.
1. Micheli LJ, Wood R. Back pain in young athletes. Significant differences from adults in causes and patterns. Arch Pediatr Adolesc Med. 1995;149(1):15-18.
2. Sakai T, Sairyo K, Suzue N, Kosaka H, Yasui N. Incidence and etiology of lumbar spondylolysis: review of the literature. J Orthop Sci. 2010;15(3):281-288.
3. Standaert CJ, Herring SA. Expert opinion and controversies in sports and musculoskeletal medicine: the diagnosis and treatment of spondylolysis in adolescent athletes. Arch Phys Med Rehabil. 2007;88(4):537-540.
4. Campbell RS, Grainger AJ, Hide IG, Papastefanou S, Greenough CG. Juvenile spondylolysis: a comparative analysis of CT, SPECT and MRI. Skeletal Radiol. 2005;34(2):63-73.
5. Kalichman L, Kim DH, Li L, Guermazi A, Berkin V, Hunter DJ. Spondylolysis and spondylolisthesis: prevalence and association with low back pain in the adult community-based population. Spine. 2009;34(2):199-205.
6. Zukotynski K, Curtis C, Grant FD, Micheli L, Treves ST. The value of SPECT in the detection of stress injury to the pars interarticularis in patients with low back pain. J Orthop Surg Res. 2010;5:13.
7. Leone A, Cianfoni A, Cerase A, Magarelli N, Bonomo L. Lumbar spondylolysis: a review. Skeletal Radiol. 2011;40(6):683-700.
8. Gregory PL, Batt ME, Kerslake RW, Scammell BE, Webb JF. The value of combining single photon emission computerised tomography and computerised tomography in the investigation of spondylolysis. Eur Spine J. 2004;13(6):503-509.
9. Brenner DJ, Hall EJ. Computed tomography—an increasing source of radiation exposure. N Engl J Med. 2007;357(22):2277-2284.
10. Brenner DJ, Shuryak I, Einstein AJ. Impact of reduced patient life expectancy on potential cancer risks from radiologic imaging. Radiology. 2011;261(1):193-198.
11. Sairyo K, Sakai T, Yasui N, Dezawa A. Conservative treatment for pediatric lumbar spondylolysis to achieve bone healing using a hard brace: what type and how long?: Clinical article. J Neurosurg Spine. 2012;16(6):610-614.
12. Steiner ME, Micheli LJ. Treatment of symptomatic spondylolysis and spondylolisthesis with the modified Boston brace. Spine. 1985;10(10):937-943.
13. Sairyo K, Katoh S, Takata Y, et al. MRI signal changes of the pedicle as an indicator for early diagnosis of spondylolysis in children and adolescents: a clinical and biomechanical study. Spine. 2006;31(2):206-211.
14. Sakai T, Sairyo K, Mima S, Yasui N. Significance of magnetic resonance imaging signal change in the pedicle in the management of pediatric lumbar spondylolysis. Spine. 2010;35(14):E641-E645.
15. Fujii K, Katoh S, Sairyo K, Ikata T, Yasui N. Union of defects in the pars interarticularis of the lumbar spine in children and adolescents. The radiological outcome after conservative treatment. J Bone Joint Surg Br. 2004;86(2):225-231.
16. Gregg CD, Dean S, Schneiders AG. Variables associated with active spondylolysis. Phys Ther Sport. 2009;10(4):121-124.
17. Kobayashi A, Kobayashi T, Kato K, Higuchi H, Takagishi K. Diagnosis of radiographically occult lumbar spondylolysis in young athletes by magnetic resonance imaging. Am J Sports Med. 2013;41(1):169-176.
18. Masci L, Pike J, Malara F, Phillips B, Bennell K, Brukner P. Use of the one-legged hyperextension test and magnetic resonance imaging in the diagnosis of active spondylolysis. Br J Sports Med. 2006;40(11):940-946.
19. Beutler WJ, Fredrickson BE, Murtland A, Sweeney CA, Grant WD, Baker D. The natural history of spondylolysis and spondylolisthesis: 45-year follow-up evaluation. Spine. 2003;28(10):1027-1035.
20. Miller SF, Congeni J, Swanson K. Long-term functional and anatomical follow-up of early detected spondylolysis in young athletes. Am J Sports Med. 2004;32(4):928-933.
21. Zanchetta JR, Plotkin H, Alvarez Filgueira ML. Bone mass in children: normative values for the 2-20-year-old population. Bone. 1995;16(4 suppl):393S-399S.
22. Kondratek M, Krauss J, Stiller C, Olson R. Normative values for active lumbar range of motion in children. Pediatr Phys Ther. 2007;19(3):236-244.
23. Hardcastle P, Annear P, Foster DH, et al. Spinal abnormalities in young fast bowlers. J Bone Joint Surg Br. 1992;74(3):421-425.
24. Fredrickson BE, Baker D, McHolick WJ, Yuan HA, Lubicky JP. The natural history of spondylolysis and spondylolisthesis. J Bone Joint Surg Am. 1984;66(5):699-707.
Spondylolysis, a defect in the pars interarticularis, is the single most common identifiable source of persistent low back pain in adolescent athletes.1,2 The diagnosis of spondylolysis is confirmed by radiographic imaging.3 However, there is controversy regarding which imaging modality is preferred—specifically, which to use for first-line advanced imaging after plain radiographs are obtained.3 Single-photon emission computed tomography (SPECT) consistently has been shown to be the most sensitive modality, and it is considered the gold standard.4-7 Patients with a positive SPECT scan are then routinely imaged with computed tomography (CT) for bone detail and staging of the pars defect.8 This imaging or diagnostic sequence yields organ-specific radiation doses (15-30 mSv) as much as 50-fold higher than those of plain radiography.9 Recent epidemiologic studies have shown that this organ dose results in an increased risk of cancer, especially in children.10
Diagnosis is crucial in early-stage lumbar spondylolysis, as osseous healing can occur with conservative treatment.11,12 High signal change (HSC) in the pedicle or pars interarticularis (Figure 1) on fluid-specific (T2) magnetic resonance imaging (MRI) sequences has been shown to be important in the diagnosis of early spondylolysis and, subsequently, a good predictor of bony healing.13,14 We conducted a study to determine the clinical and radiographic characteristics associated with the diagnosis of early or active spondylolysis.
Materials and Methods
The study was reviewed and approved by the local institutional review board. Using the International Classification of Diseases, Ninth Revision (ICD-9) diagnosis code for spondylolysis (756.11), we retrospectively identified patients (age, 12-21 years) from 2002–2011 billing data from a single specialty spine practice. Baseline data—including height, weight, sex, age, symptom duration, sporting activities, defect location, pain score, and previous treatments—were collected from a standardized patient intake questionnaire and office medical records. We also determined radiographic data, including level, laterality (right vs left, unilateral vs bilateral), presence of listhesis, and slip grade and percentage. CT scans were reviewed to confirm the spondylolysis diagnosis and to measure parameters described by Fujii and colleagues.15 These parameters include spondylolysis chronicity (early, progressive, terminal) (Figure 2), distance from defect to posterior margin of vertebral body, and defect angle relative to posterior margin of vertebral body. We also measured sagittal radiographic parameters, including pelvic incidence and lumbar lordosis.
Pars lesions were divided into active and inactive defects16 based on signal characteristics on either MRI or SPECT (Figure 3). Defects with a positive SPECT or HSC on T2 MRI were classified as active; all other defects were classified as inactive. All MRIs were reviewed by a radiologist, and any mention of HSC in the pedicle or pars of the corresponding level was considered positive. For the sake of accuracy, all MRIs were also reviewed by a spine surgeon. All CT measurements were done by 1 of 2 authors. Demographic, clinical, and radiographic characteristics were compared between patients with active defects and patients with inactive defects. Independent t tests and Fisher exact tests were used to compare continuous and categorical variables, respectively. Threshold P was set at .01 to account for the small sample size and multiple concurrent comparisons.
Results
Fifty-seven patients (29 males, 28 females) with a total of 108 pars defects (6 unilateral, 102 bilateral) were identified. Mean age was 14.64 years. Of the 108 defects, 49 were classified as active and 59 as inactive. SPECT results were available for 52 defects, MRI results for 85, and CT results for 76 (Table 1). There was no difference between the active and inactive groups in age (14.7 vs 14.6 years; P = .083), body mass index (24.2 vs 21.7 kg/m2; P = .034), symptom duration (236.3 vs 397.4 days; P = .016), lumbar lordosis (27.4° vs 32.1°; P = .097), pelvic incidence (59.0° vs 61.2°; P = .488), slip percentage (9.5% vs 14.2%; P = .034), and laterality (right vs left, P = .847; unilateral vs bilateral, P = .281) (Table 2). There was a significant difference between the active and inactive groups in sex (35 vs 19 males; P < .0001) and presence of listhesis (16 vs 35; P = .006) (Table 2).
Of the 49 active defects, 3 were graded as early, 10 as progressive, and 11 as terminal (Table 3). There was a statistically significant (P < .0001) difference between active and inactive lesions for each stage. Mean distance from posterior margin of the vertebral body was 0.57 mm and 0.68 mm for inactive and active lesions, respectively (P = .007). There was no significant difference (P = .294) in the posterior angle of the vertebral body and the defect between inactive (20.54°) and active (24.73°) lesions (Table 3).
Subanalysis by sex showed no difference in age (males, 16.4 years vs females, 18.7 years; P = .073), slip percentage (10.4% vs 13.4%; P = .168), or presence or absence of slip (25 vs 26; P > .99) (Table 4).
Discussion
Increasing MRI resolution combined with increasing concern about unnecessary radiation exposure has added to the attractiveness of MRI in the diagnosis of spondylolysis. Spondylolysis progresses on a continuum, starting with a stress reaction (early or active defect) and ending with either healing or nonunion of the pars defect (terminal defect) (Figure 4). Although risk factors for progression are not clearly defined, Fujii and colleagues15 showed that the reaction around the defect is the most important factor for osseous union. It would then make sense that the earlier the spondylolytic defect is identified, the higher the likelihood for union, especially with nonoperative treatment such as rest, activity restriction, and bracing.12,17
There is a lack of consensus regarding MRI use in the diagnosis of spondylolysis. Masci and colleagues18 prospectively evaluated 50 defects in 39 patients using a 1.5-Tesla MRI scanner, concluded MRI is inferior to SPECT/CT, and recommended that SPECT remain the first-line advanced imaging modality. Conversely, Campbell and colleagues4 prospectively evaluated 40 defects in 22 patients using a 1.0-Tesla magnet and concluded that MRI can be used as an effective and reliable first-line advanced imaging modality. These are the only 2 prospective studies conducted within the past decade. Both were underpowered and used outdated technology (newer MRI scanners use 3.0-Tesla magnets). In addition, specific imaging characteristics (eg, edema in pars or pedicle on fluid-specific sequences) that suggest a positive finding—versus overt fracture on T1 MRI—have been recently emphasized. Neither Masci and colleagues18 nor Campbell and colleagues4 detailed what constituted a positive MRI finding. Although an adequately powered prospective study will provide a better analysis of the utility of MRI versus SPECT, such a study is costly and time-consuming. It is important to identify patient and lesion characteristics to help optimize the usefulness of MRI. It is also important to identify the subset of patients most likely to experience osseous healing of active defects,16 as this is the same subset of patients most likely to respond to nonoperative treatment.
We conducted the present study to identify any clinical or radiographic characteristics associated with the diagnosis of early or active spondylolysis. Almost equal numbers of active and inactive defects (49, 59) were identified. There were no differences in patient characteristics, including age, body mass index, and symptom duration. However, there was a significant sex difference—a relatively high proportion of males with active spondylolysis. This finding, which had been reported before,16,19,20 is probably the result of several factors, including males’ lower lumbar spine bone mineral density21; their relatively less spinal flexibility, which affects the distribution of torsional loads on the spine22; and their relatively greater participation in sports, especially sports involving high-velocity, torsional loading of the lumbar spine.23 Studies are needed to delineate the extent to which sex influences the development and persistence of active spondylolytic lesions. Alternatively, a subanalysis revealed an age difference, between our female and male cohorts (18.7 vs 16.4 years), that may have contributed to the high proportion of males with active spondylolysis.
Although the groups’ difference in symptom duration was not significant, it was trending toward significance. As discussed, it could be explained that, along the continuum of disease, earlier defects are more active and either achieve fibrous or osseous union or become chronic and “burn out” to inactive lesions, potentially leading to a listhesis.24 The listhesis association was higher in the inactive group than in the active group (P = .006). The difference in numbers of active and inactive defects at each stage (early, progressive, late) confirms this finding, with no inactive lesions in the early and progressive stages and many fewer active lesions in the terminal stage. Overall, presence of a spondylolisthesis on plain radiographs may obviate the need for SPECT or MRI, as it indicates an inactive chronic lesion—unless new symptoms are suspicious for reactivation or development of previously described adjacent-level pars defects.
No other radiographic parameters were found to be significant—consistent with findings of other studies.2,5,16 Pelvic incidence has been shown to predict progression of spondylisthesis, but under our study parameters it appears not to be associated with development of a slip.
This study had several weaknesses. First, it was retrospective, and imaging parameters were inconsistent, as we included patients who underwent imaging at other facilities. Second, the timing of imaging was inconsistent. Ideally, the same sequence protocol would be used, and all imaging studies (MRI, SPECT, CT) would be performed within a specific period after the initial concern for a spondylolysis was raised. Last, not all patients underwent all 3 advanced imaging modalities; having all 3 would have allowed for a retrospective comparison of MRI and SPECT sensitivity in detecting spondylolysis. Such a comparison would have been interesting, though it was not the goal of this study.
With its technological improvements and lack of radiation exposure, MRI is becoming more attractive as a first-line advanced imaging modality. Although the superiority of MRI over SPECT is yet to be confirmed, clinical use of MRI in the evaluation of spondylolysis seems to be increasing. It is therefore important to characterize the spondylolytic defects that are readily detected with MRI.
Active or early juvenile spondylolysis appears to be associated with males and absence of an associated listhesis. These clinical and radiographic characteristics may be important in the identification of patients with higher potential for osseous healing after nonoperative treatment.
Spondylolysis, a defect in the pars interarticularis, is the single most common identifiable source of persistent low back pain in adolescent athletes.1,2 The diagnosis of spondylolysis is confirmed by radiographic imaging.3 However, there is controversy regarding which imaging modality is preferred—specifically, which to use for first-line advanced imaging after plain radiographs are obtained.3 Single-photon emission computed tomography (SPECT) consistently has been shown to be the most sensitive modality, and it is considered the gold standard.4-7 Patients with a positive SPECT scan are then routinely imaged with computed tomography (CT) for bone detail and staging of the pars defect.8 This imaging or diagnostic sequence yields organ-specific radiation doses (15-30 mSv) as much as 50-fold higher than those of plain radiography.9 Recent epidemiologic studies have shown that this organ dose results in an increased risk of cancer, especially in children.10
Diagnosis is crucial in early-stage lumbar spondylolysis, as osseous healing can occur with conservative treatment.11,12 High signal change (HSC) in the pedicle or pars interarticularis (Figure 1) on fluid-specific (T2) magnetic resonance imaging (MRI) sequences has been shown to be important in the diagnosis of early spondylolysis and, subsequently, a good predictor of bony healing.13,14 We conducted a study to determine the clinical and radiographic characteristics associated with the diagnosis of early or active spondylolysis.
Materials and Methods
The study was reviewed and approved by the local institutional review board. Using the International Classification of Diseases, Ninth Revision (ICD-9) diagnosis code for spondylolysis (756.11), we retrospectively identified patients (age, 12-21 years) from 2002–2011 billing data from a single specialty spine practice. Baseline data—including height, weight, sex, age, symptom duration, sporting activities, defect location, pain score, and previous treatments—were collected from a standardized patient intake questionnaire and office medical records. We also determined radiographic data, including level, laterality (right vs left, unilateral vs bilateral), presence of listhesis, and slip grade and percentage. CT scans were reviewed to confirm the spondylolysis diagnosis and to measure parameters described by Fujii and colleagues.15 These parameters include spondylolysis chronicity (early, progressive, terminal) (Figure 2), distance from defect to posterior margin of vertebral body, and defect angle relative to posterior margin of vertebral body. We also measured sagittal radiographic parameters, including pelvic incidence and lumbar lordosis.
Pars lesions were divided into active and inactive defects16 based on signal characteristics on either MRI or SPECT (Figure 3). Defects with a positive SPECT or HSC on T2 MRI were classified as active; all other defects were classified as inactive. All MRIs were reviewed by a radiologist, and any mention of HSC in the pedicle or pars of the corresponding level was considered positive. For the sake of accuracy, all MRIs were also reviewed by a spine surgeon. All CT measurements were done by 1 of 2 authors. Demographic, clinical, and radiographic characteristics were compared between patients with active defects and patients with inactive defects. Independent t tests and Fisher exact tests were used to compare continuous and categorical variables, respectively. Threshold P was set at .01 to account for the small sample size and multiple concurrent comparisons.
Results
Fifty-seven patients (29 males, 28 females) with a total of 108 pars defects (6 unilateral, 102 bilateral) were identified. Mean age was 14.64 years. Of the 108 defects, 49 were classified as active and 59 as inactive. SPECT results were available for 52 defects, MRI results for 85, and CT results for 76 (Table 1). There was no difference between the active and inactive groups in age (14.7 vs 14.6 years; P = .083), body mass index (24.2 vs 21.7 kg/m2; P = .034), symptom duration (236.3 vs 397.4 days; P = .016), lumbar lordosis (27.4° vs 32.1°; P = .097), pelvic incidence (59.0° vs 61.2°; P = .488), slip percentage (9.5% vs 14.2%; P = .034), and laterality (right vs left, P = .847; unilateral vs bilateral, P = .281) (Table 2). There was a significant difference between the active and inactive groups in sex (35 vs 19 males; P < .0001) and presence of listhesis (16 vs 35; P = .006) (Table 2).
Of the 49 active defects, 3 were graded as early, 10 as progressive, and 11 as terminal (Table 3). There was a statistically significant (P < .0001) difference between active and inactive lesions for each stage. Mean distance from posterior margin of the vertebral body was 0.57 mm and 0.68 mm for inactive and active lesions, respectively (P = .007). There was no significant difference (P = .294) in the posterior angle of the vertebral body and the defect between inactive (20.54°) and active (24.73°) lesions (Table 3).
Subanalysis by sex showed no difference in age (males, 16.4 years vs females, 18.7 years; P = .073), slip percentage (10.4% vs 13.4%; P = .168), or presence or absence of slip (25 vs 26; P > .99) (Table 4).
Discussion
Increasing MRI resolution combined with increasing concern about unnecessary radiation exposure has added to the attractiveness of MRI in the diagnosis of spondylolysis. Spondylolysis progresses on a continuum, starting with a stress reaction (early or active defect) and ending with either healing or nonunion of the pars defect (terminal defect) (Figure 4). Although risk factors for progression are not clearly defined, Fujii and colleagues15 showed that the reaction around the defect is the most important factor for osseous union. It would then make sense that the earlier the spondylolytic defect is identified, the higher the likelihood for union, especially with nonoperative treatment such as rest, activity restriction, and bracing.12,17
There is a lack of consensus regarding MRI use in the diagnosis of spondylolysis. Masci and colleagues18 prospectively evaluated 50 defects in 39 patients using a 1.5-Tesla MRI scanner, concluded MRI is inferior to SPECT/CT, and recommended that SPECT remain the first-line advanced imaging modality. Conversely, Campbell and colleagues4 prospectively evaluated 40 defects in 22 patients using a 1.0-Tesla magnet and concluded that MRI can be used as an effective and reliable first-line advanced imaging modality. These are the only 2 prospective studies conducted within the past decade. Both were underpowered and used outdated technology (newer MRI scanners use 3.0-Tesla magnets). In addition, specific imaging characteristics (eg, edema in pars or pedicle on fluid-specific sequences) that suggest a positive finding—versus overt fracture on T1 MRI—have been recently emphasized. Neither Masci and colleagues18 nor Campbell and colleagues4 detailed what constituted a positive MRI finding. Although an adequately powered prospective study will provide a better analysis of the utility of MRI versus SPECT, such a study is costly and time-consuming. It is important to identify patient and lesion characteristics to help optimize the usefulness of MRI. It is also important to identify the subset of patients most likely to experience osseous healing of active defects,16 as this is the same subset of patients most likely to respond to nonoperative treatment.
We conducted the present study to identify any clinical or radiographic characteristics associated with the diagnosis of early or active spondylolysis. Almost equal numbers of active and inactive defects (49, 59) were identified. There were no differences in patient characteristics, including age, body mass index, and symptom duration. However, there was a significant sex difference—a relatively high proportion of males with active spondylolysis. This finding, which had been reported before,16,19,20 is probably the result of several factors, including males’ lower lumbar spine bone mineral density21; their relatively less spinal flexibility, which affects the distribution of torsional loads on the spine22; and their relatively greater participation in sports, especially sports involving high-velocity, torsional loading of the lumbar spine.23 Studies are needed to delineate the extent to which sex influences the development and persistence of active spondylolytic lesions. Alternatively, a subanalysis revealed an age difference, between our female and male cohorts (18.7 vs 16.4 years), that may have contributed to the high proportion of males with active spondylolysis.
Although the groups’ difference in symptom duration was not significant, it was trending toward significance. As discussed, it could be explained that, along the continuum of disease, earlier defects are more active and either achieve fibrous or osseous union or become chronic and “burn out” to inactive lesions, potentially leading to a listhesis.24 The listhesis association was higher in the inactive group than in the active group (P = .006). The difference in numbers of active and inactive defects at each stage (early, progressive, late) confirms this finding, with no inactive lesions in the early and progressive stages and many fewer active lesions in the terminal stage. Overall, presence of a spondylolisthesis on plain radiographs may obviate the need for SPECT or MRI, as it indicates an inactive chronic lesion—unless new symptoms are suspicious for reactivation or development of previously described adjacent-level pars defects.
No other radiographic parameters were found to be significant—consistent with findings of other studies.2,5,16 Pelvic incidence has been shown to predict progression of spondylisthesis, but under our study parameters it appears not to be associated with development of a slip.
This study had several weaknesses. First, it was retrospective, and imaging parameters were inconsistent, as we included patients who underwent imaging at other facilities. Second, the timing of imaging was inconsistent. Ideally, the same sequence protocol would be used, and all imaging studies (MRI, SPECT, CT) would be performed within a specific period after the initial concern for a spondylolysis was raised. Last, not all patients underwent all 3 advanced imaging modalities; having all 3 would have allowed for a retrospective comparison of MRI and SPECT sensitivity in detecting spondylolysis. Such a comparison would have been interesting, though it was not the goal of this study.
With its technological improvements and lack of radiation exposure, MRI is becoming more attractive as a first-line advanced imaging modality. Although the superiority of MRI over SPECT is yet to be confirmed, clinical use of MRI in the evaluation of spondylolysis seems to be increasing. It is therefore important to characterize the spondylolytic defects that are readily detected with MRI.
Active or early juvenile spondylolysis appears to be associated with males and absence of an associated listhesis. These clinical and radiographic characteristics may be important in the identification of patients with higher potential for osseous healing after nonoperative treatment.
1. Micheli LJ, Wood R. Back pain in young athletes. Significant differences from adults in causes and patterns. Arch Pediatr Adolesc Med. 1995;149(1):15-18.
2. Sakai T, Sairyo K, Suzue N, Kosaka H, Yasui N. Incidence and etiology of lumbar spondylolysis: review of the literature. J Orthop Sci. 2010;15(3):281-288.
3. Standaert CJ, Herring SA. Expert opinion and controversies in sports and musculoskeletal medicine: the diagnosis and treatment of spondylolysis in adolescent athletes. Arch Phys Med Rehabil. 2007;88(4):537-540.
4. Campbell RS, Grainger AJ, Hide IG, Papastefanou S, Greenough CG. Juvenile spondylolysis: a comparative analysis of CT, SPECT and MRI. Skeletal Radiol. 2005;34(2):63-73.
5. Kalichman L, Kim DH, Li L, Guermazi A, Berkin V, Hunter DJ. Spondylolysis and spondylolisthesis: prevalence and association with low back pain in the adult community-based population. Spine. 2009;34(2):199-205.
6. Zukotynski K, Curtis C, Grant FD, Micheli L, Treves ST. The value of SPECT in the detection of stress injury to the pars interarticularis in patients with low back pain. J Orthop Surg Res. 2010;5:13.
7. Leone A, Cianfoni A, Cerase A, Magarelli N, Bonomo L. Lumbar spondylolysis: a review. Skeletal Radiol. 2011;40(6):683-700.
8. Gregory PL, Batt ME, Kerslake RW, Scammell BE, Webb JF. The value of combining single photon emission computerised tomography and computerised tomography in the investigation of spondylolysis. Eur Spine J. 2004;13(6):503-509.
9. Brenner DJ, Hall EJ. Computed tomography—an increasing source of radiation exposure. N Engl J Med. 2007;357(22):2277-2284.
10. Brenner DJ, Shuryak I, Einstein AJ. Impact of reduced patient life expectancy on potential cancer risks from radiologic imaging. Radiology. 2011;261(1):193-198.
11. Sairyo K, Sakai T, Yasui N, Dezawa A. Conservative treatment for pediatric lumbar spondylolysis to achieve bone healing using a hard brace: what type and how long?: Clinical article. J Neurosurg Spine. 2012;16(6):610-614.
12. Steiner ME, Micheli LJ. Treatment of symptomatic spondylolysis and spondylolisthesis with the modified Boston brace. Spine. 1985;10(10):937-943.
13. Sairyo K, Katoh S, Takata Y, et al. MRI signal changes of the pedicle as an indicator for early diagnosis of spondylolysis in children and adolescents: a clinical and biomechanical study. Spine. 2006;31(2):206-211.
14. Sakai T, Sairyo K, Mima S, Yasui N. Significance of magnetic resonance imaging signal change in the pedicle in the management of pediatric lumbar spondylolysis. Spine. 2010;35(14):E641-E645.
15. Fujii K, Katoh S, Sairyo K, Ikata T, Yasui N. Union of defects in the pars interarticularis of the lumbar spine in children and adolescents. The radiological outcome after conservative treatment. J Bone Joint Surg Br. 2004;86(2):225-231.
16. Gregg CD, Dean S, Schneiders AG. Variables associated with active spondylolysis. Phys Ther Sport. 2009;10(4):121-124.
17. Kobayashi A, Kobayashi T, Kato K, Higuchi H, Takagishi K. Diagnosis of radiographically occult lumbar spondylolysis in young athletes by magnetic resonance imaging. Am J Sports Med. 2013;41(1):169-176.
18. Masci L, Pike J, Malara F, Phillips B, Bennell K, Brukner P. Use of the one-legged hyperextension test and magnetic resonance imaging in the diagnosis of active spondylolysis. Br J Sports Med. 2006;40(11):940-946.
19. Beutler WJ, Fredrickson BE, Murtland A, Sweeney CA, Grant WD, Baker D. The natural history of spondylolysis and spondylolisthesis: 45-year follow-up evaluation. Spine. 2003;28(10):1027-1035.
20. Miller SF, Congeni J, Swanson K. Long-term functional and anatomical follow-up of early detected spondylolysis in young athletes. Am J Sports Med. 2004;32(4):928-933.
21. Zanchetta JR, Plotkin H, Alvarez Filgueira ML. Bone mass in children: normative values for the 2-20-year-old population. Bone. 1995;16(4 suppl):393S-399S.
22. Kondratek M, Krauss J, Stiller C, Olson R. Normative values for active lumbar range of motion in children. Pediatr Phys Ther. 2007;19(3):236-244.
23. Hardcastle P, Annear P, Foster DH, et al. Spinal abnormalities in young fast bowlers. J Bone Joint Surg Br. 1992;74(3):421-425.
24. Fredrickson BE, Baker D, McHolick WJ, Yuan HA, Lubicky JP. The natural history of spondylolysis and spondylolisthesis. J Bone Joint Surg Am. 1984;66(5):699-707.
1. Micheli LJ, Wood R. Back pain in young athletes. Significant differences from adults in causes and patterns. Arch Pediatr Adolesc Med. 1995;149(1):15-18.
2. Sakai T, Sairyo K, Suzue N, Kosaka H, Yasui N. Incidence and etiology of lumbar spondylolysis: review of the literature. J Orthop Sci. 2010;15(3):281-288.
3. Standaert CJ, Herring SA. Expert opinion and controversies in sports and musculoskeletal medicine: the diagnosis and treatment of spondylolysis in adolescent athletes. Arch Phys Med Rehabil. 2007;88(4):537-540.
4. Campbell RS, Grainger AJ, Hide IG, Papastefanou S, Greenough CG. Juvenile spondylolysis: a comparative analysis of CT, SPECT and MRI. Skeletal Radiol. 2005;34(2):63-73.
5. Kalichman L, Kim DH, Li L, Guermazi A, Berkin V, Hunter DJ. Spondylolysis and spondylolisthesis: prevalence and association with low back pain in the adult community-based population. Spine. 2009;34(2):199-205.
6. Zukotynski K, Curtis C, Grant FD, Micheli L, Treves ST. The value of SPECT in the detection of stress injury to the pars interarticularis in patients with low back pain. J Orthop Surg Res. 2010;5:13.
7. Leone A, Cianfoni A, Cerase A, Magarelli N, Bonomo L. Lumbar spondylolysis: a review. Skeletal Radiol. 2011;40(6):683-700.
8. Gregory PL, Batt ME, Kerslake RW, Scammell BE, Webb JF. The value of combining single photon emission computerised tomography and computerised tomography in the investigation of spondylolysis. Eur Spine J. 2004;13(6):503-509.
9. Brenner DJ, Hall EJ. Computed tomography—an increasing source of radiation exposure. N Engl J Med. 2007;357(22):2277-2284.
10. Brenner DJ, Shuryak I, Einstein AJ. Impact of reduced patient life expectancy on potential cancer risks from radiologic imaging. Radiology. 2011;261(1):193-198.
11. Sairyo K, Sakai T, Yasui N, Dezawa A. Conservative treatment for pediatric lumbar spondylolysis to achieve bone healing using a hard brace: what type and how long?: Clinical article. J Neurosurg Spine. 2012;16(6):610-614.
12. Steiner ME, Micheli LJ. Treatment of symptomatic spondylolysis and spondylolisthesis with the modified Boston brace. Spine. 1985;10(10):937-943.
13. Sairyo K, Katoh S, Takata Y, et al. MRI signal changes of the pedicle as an indicator for early diagnosis of spondylolysis in children and adolescents: a clinical and biomechanical study. Spine. 2006;31(2):206-211.
14. Sakai T, Sairyo K, Mima S, Yasui N. Significance of magnetic resonance imaging signal change in the pedicle in the management of pediatric lumbar spondylolysis. Spine. 2010;35(14):E641-E645.
15. Fujii K, Katoh S, Sairyo K, Ikata T, Yasui N. Union of defects in the pars interarticularis of the lumbar spine in children and adolescents. The radiological outcome after conservative treatment. J Bone Joint Surg Br. 2004;86(2):225-231.
16. Gregg CD, Dean S, Schneiders AG. Variables associated with active spondylolysis. Phys Ther Sport. 2009;10(4):121-124.
17. Kobayashi A, Kobayashi T, Kato K, Higuchi H, Takagishi K. Diagnosis of radiographically occult lumbar spondylolysis in young athletes by magnetic resonance imaging. Am J Sports Med. 2013;41(1):169-176.
18. Masci L, Pike J, Malara F, Phillips B, Bennell K, Brukner P. Use of the one-legged hyperextension test and magnetic resonance imaging in the diagnosis of active spondylolysis. Br J Sports Med. 2006;40(11):940-946.
19. Beutler WJ, Fredrickson BE, Murtland A, Sweeney CA, Grant WD, Baker D. The natural history of spondylolysis and spondylolisthesis: 45-year follow-up evaluation. Spine. 2003;28(10):1027-1035.
20. Miller SF, Congeni J, Swanson K. Long-term functional and anatomical follow-up of early detected spondylolysis in young athletes. Am J Sports Med. 2004;32(4):928-933.
21. Zanchetta JR, Plotkin H, Alvarez Filgueira ML. Bone mass in children: normative values for the 2-20-year-old population. Bone. 1995;16(4 suppl):393S-399S.
22. Kondratek M, Krauss J, Stiller C, Olson R. Normative values for active lumbar range of motion in children. Pediatr Phys Ther. 2007;19(3):236-244.
23. Hardcastle P, Annear P, Foster DH, et al. Spinal abnormalities in young fast bowlers. J Bone Joint Surg Br. 1992;74(3):421-425.
24. Fredrickson BE, Baker D, McHolick WJ, Yuan HA, Lubicky JP. The natural history of spondylolysis and spondylolisthesis. J Bone Joint Surg Am. 1984;66(5):699-707.
Business and Practice Management Knowledge Deficiencies in Graduating Orthopedic Residents
With the increasing complexity of health care policy, significant changes in reimbursement and payer sources, and constant push to improve the cost-efficiency of care delivery, there has been a growing focus on the importance of business knowledge and practice management (PM) skills among physicians. Family medicine was the first specialty to require PM training during residency; other specialities have begun implementing business training into their residency curriculum.1 In 1999, the Accreditation Council for Graduate Medical Education (ACGME) identified 6 core competencies that should be included in resident training. One of these core competencies involves training in health care systems and PM.2,3
Residency program directors have also recognized the need for business training among residents. One study that surveyed general surgery program directors found that more than 87% agreed that residents should be trained in business and PM.4 Although these directors recognized the need for training, they also acknowledged the current deficiency: more than 70% thought their current trainees were inadequately trained in business and PM. Similarly, residents and physicians in multiple specialties have reported significant deficiencies in their training and knowledge of PM and business principles.5-11 For example, in a recent survey of ophthalmologists who had been in practice less than 5 years, 70% reported being not very well or not at all trained in overall PM skills during residency.5 Yet, most respondents thought training in this area was the responsibility of the training program.
The call for more business and PM training during residency has been tempered by increasing demands on medical and surgical skills training and time limitations such as duty-hour restrictions. These limitations reinforce the need to find efficient and effective means of teaching necessary business knowledge and PM skills. Paramount to doing this is recognizing the difference between general knowledge and functional knowledge—essentially, what is specifically needed to function effectively in practice.
We conducted a study not only to determine the general level of knowledge that physicians have in different business and PM topics when they complete their residency, but also to evaluate the level of knowledge that graduating physicians need in different business and PM topics in order to function effectively in a medical practice. Toward this end, we developed a novel model that could help determine the level of the functional knowledge deficiency (FKD) of particular business topics. We thought this model would allow us to quantify how much knowledge physicians needed to acquire in a given topic in order to function effectively in practice. We hypothesized that graduating residents would report overall low levels of business knowledge and high FKDs.
Materials and Methods
To minimize variability in the specific type and amount of business training received, we focused this study on a single institution that had maintained a uniform business management curriculum over an extended period. The business training program provided to residents in the orthopedic surgery residency at this institution included 6 hours of didactic lectures on various business topics annually. This program has been in place for more than 15 years and has not undergone any significant changes during that time.
Using the program’s alumni directory, we emailed a cover letter and an 11-question survey to all 332 residents and fellows who had completed their residency or fellowship training at our institution between 1970 and 2008. Anyone who did not reply to the email was mailed a copy of the cover letter and the survey.
The first 4 survey questions involved the demographics of the surgeon and the surgeon’s practice. Subsequent questions focused on the surgeon’s understanding of 9 different general business and PM topics and their importance in the practice. The topics were marketing, business operations, human resources, contract negotiations, malpractice issues, coding/billing, medical records management, accounting, and economic analytical tools. The surgeon was asked to use a 10-point scale ranging from 1 (“knew nothing at all”) to 10 (“complete understanding”) to rate his or her understanding of each topic at the completion of residency. The surgeon was also asked to rate how important it was to understand that topic in the surgeon’s current practice. Again, a 10-point scale was used: 1 (“not important at all”) to 10 (“absolutely vital”) (Figure).
When the surveys were returned, their data were compiled and analyzed to determine the overall knowledge levels for each topic and the levels based on years in practice, type of practice, and level of involvement in PM. We also wanted to determine the amount of business knowledge that they needed in order to function effectively in practice (and that they lacked at time of graduation). We defined this as the FKD at graduation and calculated it as the difference between the surgeon’s reported importance of a topic in his or her current practice and his or her level of understanding of that topic at graduation. A larger FKD score represented greater deficiency, with a maximal possible FKD score of 9. A score of 0 would reflect an appropriate amount of knowledge to function effectively, and a negative score would reflect a knowledge surplus. Using the demographic information from the survey, we were then able to further analyze the levels of overall knowledge as well as the FKD for each topic with respect to length of time in practice, type of practice, and the surgeon’s involvement in PM.
We evaluated the reported levels of knowledge based on both type of practice (academic, hospital-employed, private practice) and who managed the practice (physician, nonphysician). Academic practices were defined as those associated with an academic medical center; hospital-employed practices were those in which the physician was an employee of a health system not associated with an academic medical center; and private practices were defined as physician-owned orthopedic practices not associated with an academic medical center. Regarding management, practices in which physicians were primarily responsible for the daily operations of the practice were considered physician-managed; conversely, practices in which operations were controlled by either employed or institutionally assigned administration were defined as nonphysician-managed.
Statistical analysis of the results for different practice types and levels of involvement in management was performed for both general knowledge and FKD. Means, medians, and standard deviations were calculated. One-way analysis of variance or t tests were then used to examine mean differences overall and within each business topic. When a difference was found, a post hoc Tukey multiple range test was performed to identify it. Differences at P < .05 were considered significant.
Results
One hundred eighty-two surgeons answered the survey, yielding a response rate of 55%. All had completed their training at our institution. Seven respondents were removed from the study because they had retired from practice (5) or had returned incomplete surveys (2).
The overall self-rated level of business knowledge of all responding surgeons at the conclusion of their training was 2.4 on the 10-point scale (Table 1). Specifically, physicians reported the lowest levels of business understanding in economic analytical tools (1.5), human resources (1.7), and contract negotiations (1.9), suggesting minimal knowledge of these topics generally. They reported the highest levels of knowledge in medical records management (3.8) and malpractice issues (3.3). Even these topics, however, still reflected overall low levels of knowledge.
There was no statistically significant difference between private practice and academic physicians. In addition, surgeons in physician-managed practices reported significantly (P = .045) higher levels of understanding of economic analytical tools than surgeons in nonphysician-managed practices (Table 1). There were no other statistically significant differences among groups.
The overall calculated FKD for all surgeons was 5.6. FKDs were calculated for all 9 business topics. The worst FKDs were in business operations (6.4) and coding/billing (6.3). The topic with the least deficiency (lowest FKD) was in medical records management (4.2) (Table 2).
Surgeons’ FKDs based on practice type (academic, hospital-employed, private practice) were compared to identify potentially significant differences. Hospital-employed physicians had the lowest overall FKD (4.0), followed by physicians in academic practices (5.1) and private practices (5.9). Hospital-employed physicians reported statistically significantly better (lower) FKDs in comparison with physicians in private practice in multiple topics, including human resources, contract negotiations, malpractice issues, coding/billing, and accounting (Table 2). Similarly, physicians in academic practices also had statistically significantly better FKDs than physicians in private practice in the topics of business operations, contract negotiations, and billing/coding. Compared with hospital-employed physicians, physicians in academic practices had significantly more knowledge about marketing, business operations, and accounting. Physicians in private practice did not have significantly better FKDs in any topic in comparison with hospital-employed or academic physicians. There was no significant difference in FKDs for medical records management or economic analytical tools based on practice type.
Comparisons based on PM involvement showed that physicians in practices with nonphysician management had only a slightly better FKD (5.6) at graduation than those in practices with physician involvement (5.7). None of the 9 topics was statistically significant different based on physician involvement in PM.
Discussion
Building a successful medical practice has become more difficult for graduating orthopedic surgery residents because of an increasingly complex health care system, shrinking reimbursement rates, and looming regulatory changes. These challenges have reinforced the importance of teaching residents the necessary PM knowledge and skills to function effectively in a medical practice. Multiple studies from different specialties surveying or testing graduating residents and young practicing physicians on their business management knowledge or specific business topics have shown severe deficiencies.5-11 Unfortunately, graduating orthopedic surgery residents also appear inadequately prepared in PM. In a study of resident coding/billing knowledge, Gill and Schutt6 surveyed 2006 graduating orthopedic residents and found that only 13% felt confident in their coding ability. Our study results add to our understanding of multiple PM topics and demonstrate graduating orthopedic residents’ deficiencies throughout these topics.
Increased efforts to develop business management training programs and curricula have helped improve both overall PM and business knowledge in other specialties.12-15 ACGME now requires 100 hours of PM training among family medicine residency programs.16 A curriculum instituted in a general surgery residency focused on improving coding found that accuracy improved from 36% to 88% over 12 months.13 A family practice residency instituted a “simulated practice” model for its residents to improve practical PM learning and found statistically significant improvement over their prior didactic lectures.15 However, there continues to be significant variability in the topics and methods covered in business management curricula as programs struggle to determine how to most effectively use their limited time to prepare graduating residents.
In this study, we introduced the concept of FKD. With limited time available for teaching business knowledge and PM skills in residency, it has become imperative that training be efficient and effective. The FKD model can improve training efficiency by directing training to the topics that will produce the highest yield in preparing physicians for practice. As our results demonstrate, topics with the lowest levels of knowledge among surgeons often are not the same as the topics that are most needed to function effectively in practice (Table 3). The FKD model identifies deficiencies in practical, applicable knowledge rather than focusing on a general knowledge level. We suspect that focusing on topics with a high FKD would provide a higher yield in preparing physicians for practice. As such, our results suggest that training in business operations and coding/billing would likely provide the highest practical value, despite the fact that these were not the areas of least general knowledge.
Another finding of this study was the FKD difference based on type of practice. Compared with private practice physicians, hospital-employed or academic physicians had substantially lower overall FKDs and significantly lower FKDs in several specific topics. However, these FKD differences exist despite minimal differences in overall levels of knowledge. This would suggest that less business knowledge was needed by physicians to enter these types of practices compared with traditional private practice. We speculate that this may be one factor influencing the recent trend by graduating orthopedic residents to take hospital-employed positions, as these positions may appear less demanding in terms of learning the management aspects of the new practice.
Our results also showed slightly higher reported average business knowledge and lower FKD reported by those who had recently completed training (within 2-5 years) versus those in practice much longer. This is particularly interesting, as our institution has maintained the same lecture-based program for many years without significant changes. Although these differences may not be statistically significant, they may reflect an increased interest in and attention to learning PM skills while in training. However, we acknowledge this is only one of many possible explanations for these findings.
This study had several limitations. First, all respondents were graduates of a single institution. We were trying to limit the variability in business training, but this also limits the scope of the results. Second, self-ratings on surveys provide subjective measures of business knowledge and functional knowledge. Scores may vary based on individuals’ understanding of given topics, or they may inaccurately represent their level of understanding. This is especially true of respondents who graduated from residency, for example, 20 years earlier—their survey responses may reflect erroneous recollection of business training at time of graduation compared with respondents who graduated more recently. Conversely, more recent graduates may not have a fully formed or accurate picture of how much business knowledge is required to function in practice. Nevertheless, we found no significant differences in measured parameters based on graduation date, so we chose not to exclude older respondents, which also may have weakened our data pool. Further, FKDs are relative values used to compare subjective deficiencies rather than absolute scores of specific general knowledge. As such, subjectivity, including recollection of business training, is inherent in the model used in this study.
Conclusion
Graduating orthopedic surgeons currently appear inadequately prepared to effectively manage business issues in their practices, as evidenced by their low overall knowledge levels and high FKDs. The novel FKD model described in this study helps define FKD levels and identify topics that may provide the highest yield in improving effectiveness in practice. Residency curricula focused on improving business and PM knowledge, particularly in the topics with the highest FKDs (eg, business operations, coding/billing), may improve training efficiency in these areas. Further studies with larger numbers of physicians across multiple institutions are needed to confirm these findings and to validate the FKD concept.
1. Rose EA, Neale AV, Rathur WA. Teaching practice management during residency. Fam Med. 1999;31(2):107-113.
2. Accreditation Council for Graduate Medical Education. ACGME common program requirements. http://www.acgme.org/acgmeweb/Portals/0/PFAssets/ProgramRequirements/CPRs2013.pdf. Updated June 9, 2013. Accessed August 25, 2015.
3. Itani K. A positive approach to core competencies and benchmarks for graduate medical education. Am J Surg. 2002;184(3):196-203.
4. Lusco VC, Martinez SA, Polk HC Jr. Program directors in surgery agree that residents should be formally trained in business and practice management. Am J Surg. 2005;189(1):11-13.
5. McDonnell PJ, Kirwan TJ, Brinton GS, et al. Perceptions of recent ophthalmology residency graduates regarding preparation for practice. Ophthalmology. 2007;114(2):387-391.
6. Gill JB, Schutt RC Jr. Practice management education in orthopaedic surgical residencies. J Bone Joint Surg Am. 2007;89(1):216-219.
7. Satiani B. Business knowledge in surgeons. Am J Surg. 2004;188(1):13-16.
8. Cantor JC, Baker LC, Hughes RG. Preparedness for practice. Young physicians’ views of their professional education. JAMA. 1993;270(9):1035-1040.
9. Fakhry SM, Robinson L, Hendershot K, Reines HD. Surgical residents’ knowledge of documentation and coding for professional services: an opportunity for a focused educational offering. Am J Surg. 2007;194(2):263-267.
10. Williford LE, Ling FW, Summitt RL Jr, Stovall TG. Practice management in obstetrics and gynecology residency curriculum. Obstet Gynecol. 1999;94(3):476-479.
11. Andreae MC, Dunham K, Freed GL. Inadequate training in billing and coding as perceived by recent pediatric graduates. Clin Pediatr. 2009;48(9):939-944.
12. Kolva DE, Barzee KA, Morley CP. Practice management residency curricula: a systematic literature review. Fam Med. 2009;41(6):411-419.
13. Jones K, Lebron RA, Mangram A, Dunn E. Practice management education during surgical residency. Am J Surg. 2008;196(6):878-881.
14. Kerfoot BP, Conlin PR, Travison T, McMahon GT. Web-based education in systems-based practice: a randomized trial. Arch Intern Med. 2007;167(4):361-366.
15. LoPresti L, Ginn P, Treat R. Using a simulated practice to improve practice management learning. Fam Med. 2009;41(9):640-645.
16. Accreditation Council for Graduate Medical Education. Family medicine program requirements. https://www.acgme.org/acgmeweb/tabid/132/ProgramandInstitutionalAccreditation/MedicalSpecialties/FamilyMedicine.aspx. Accessed September 23, 2015.
With the increasing complexity of health care policy, significant changes in reimbursement and payer sources, and constant push to improve the cost-efficiency of care delivery, there has been a growing focus on the importance of business knowledge and practice management (PM) skills among physicians. Family medicine was the first specialty to require PM training during residency; other specialities have begun implementing business training into their residency curriculum.1 In 1999, the Accreditation Council for Graduate Medical Education (ACGME) identified 6 core competencies that should be included in resident training. One of these core competencies involves training in health care systems and PM.2,3
Residency program directors have also recognized the need for business training among residents. One study that surveyed general surgery program directors found that more than 87% agreed that residents should be trained in business and PM.4 Although these directors recognized the need for training, they also acknowledged the current deficiency: more than 70% thought their current trainees were inadequately trained in business and PM. Similarly, residents and physicians in multiple specialties have reported significant deficiencies in their training and knowledge of PM and business principles.5-11 For example, in a recent survey of ophthalmologists who had been in practice less than 5 years, 70% reported being not very well or not at all trained in overall PM skills during residency.5 Yet, most respondents thought training in this area was the responsibility of the training program.
The call for more business and PM training during residency has been tempered by increasing demands on medical and surgical skills training and time limitations such as duty-hour restrictions. These limitations reinforce the need to find efficient and effective means of teaching necessary business knowledge and PM skills. Paramount to doing this is recognizing the difference between general knowledge and functional knowledge—essentially, what is specifically needed to function effectively in practice.
We conducted a study not only to determine the general level of knowledge that physicians have in different business and PM topics when they complete their residency, but also to evaluate the level of knowledge that graduating physicians need in different business and PM topics in order to function effectively in a medical practice. Toward this end, we developed a novel model that could help determine the level of the functional knowledge deficiency (FKD) of particular business topics. We thought this model would allow us to quantify how much knowledge physicians needed to acquire in a given topic in order to function effectively in practice. We hypothesized that graduating residents would report overall low levels of business knowledge and high FKDs.
Materials and Methods
To minimize variability in the specific type and amount of business training received, we focused this study on a single institution that had maintained a uniform business management curriculum over an extended period. The business training program provided to residents in the orthopedic surgery residency at this institution included 6 hours of didactic lectures on various business topics annually. This program has been in place for more than 15 years and has not undergone any significant changes during that time.
Using the program’s alumni directory, we emailed a cover letter and an 11-question survey to all 332 residents and fellows who had completed their residency or fellowship training at our institution between 1970 and 2008. Anyone who did not reply to the email was mailed a copy of the cover letter and the survey.
The first 4 survey questions involved the demographics of the surgeon and the surgeon’s practice. Subsequent questions focused on the surgeon’s understanding of 9 different general business and PM topics and their importance in the practice. The topics were marketing, business operations, human resources, contract negotiations, malpractice issues, coding/billing, medical records management, accounting, and economic analytical tools. The surgeon was asked to use a 10-point scale ranging from 1 (“knew nothing at all”) to 10 (“complete understanding”) to rate his or her understanding of each topic at the completion of residency. The surgeon was also asked to rate how important it was to understand that topic in the surgeon’s current practice. Again, a 10-point scale was used: 1 (“not important at all”) to 10 (“absolutely vital”) (Figure).
When the surveys were returned, their data were compiled and analyzed to determine the overall knowledge levels for each topic and the levels based on years in practice, type of practice, and level of involvement in PM. We also wanted to determine the amount of business knowledge that they needed in order to function effectively in practice (and that they lacked at time of graduation). We defined this as the FKD at graduation and calculated it as the difference between the surgeon’s reported importance of a topic in his or her current practice and his or her level of understanding of that topic at graduation. A larger FKD score represented greater deficiency, with a maximal possible FKD score of 9. A score of 0 would reflect an appropriate amount of knowledge to function effectively, and a negative score would reflect a knowledge surplus. Using the demographic information from the survey, we were then able to further analyze the levels of overall knowledge as well as the FKD for each topic with respect to length of time in practice, type of practice, and the surgeon’s involvement in PM.
We evaluated the reported levels of knowledge based on both type of practice (academic, hospital-employed, private practice) and who managed the practice (physician, nonphysician). Academic practices were defined as those associated with an academic medical center; hospital-employed practices were those in which the physician was an employee of a health system not associated with an academic medical center; and private practices were defined as physician-owned orthopedic practices not associated with an academic medical center. Regarding management, practices in which physicians were primarily responsible for the daily operations of the practice were considered physician-managed; conversely, practices in which operations were controlled by either employed or institutionally assigned administration were defined as nonphysician-managed.
Statistical analysis of the results for different practice types and levels of involvement in management was performed for both general knowledge and FKD. Means, medians, and standard deviations were calculated. One-way analysis of variance or t tests were then used to examine mean differences overall and within each business topic. When a difference was found, a post hoc Tukey multiple range test was performed to identify it. Differences at P < .05 were considered significant.
Results
One hundred eighty-two surgeons answered the survey, yielding a response rate of 55%. All had completed their training at our institution. Seven respondents were removed from the study because they had retired from practice (5) or had returned incomplete surveys (2).
The overall self-rated level of business knowledge of all responding surgeons at the conclusion of their training was 2.4 on the 10-point scale (Table 1). Specifically, physicians reported the lowest levels of business understanding in economic analytical tools (1.5), human resources (1.7), and contract negotiations (1.9), suggesting minimal knowledge of these topics generally. They reported the highest levels of knowledge in medical records management (3.8) and malpractice issues (3.3). Even these topics, however, still reflected overall low levels of knowledge.
There was no statistically significant difference between private practice and academic physicians. In addition, surgeons in physician-managed practices reported significantly (P = .045) higher levels of understanding of economic analytical tools than surgeons in nonphysician-managed practices (Table 1). There were no other statistically significant differences among groups.
The overall calculated FKD for all surgeons was 5.6. FKDs were calculated for all 9 business topics. The worst FKDs were in business operations (6.4) and coding/billing (6.3). The topic with the least deficiency (lowest FKD) was in medical records management (4.2) (Table 2).
Surgeons’ FKDs based on practice type (academic, hospital-employed, private practice) were compared to identify potentially significant differences. Hospital-employed physicians had the lowest overall FKD (4.0), followed by physicians in academic practices (5.1) and private practices (5.9). Hospital-employed physicians reported statistically significantly better (lower) FKDs in comparison with physicians in private practice in multiple topics, including human resources, contract negotiations, malpractice issues, coding/billing, and accounting (Table 2). Similarly, physicians in academic practices also had statistically significantly better FKDs than physicians in private practice in the topics of business operations, contract negotiations, and billing/coding. Compared with hospital-employed physicians, physicians in academic practices had significantly more knowledge about marketing, business operations, and accounting. Physicians in private practice did not have significantly better FKDs in any topic in comparison with hospital-employed or academic physicians. There was no significant difference in FKDs for medical records management or economic analytical tools based on practice type.
Comparisons based on PM involvement showed that physicians in practices with nonphysician management had only a slightly better FKD (5.6) at graduation than those in practices with physician involvement (5.7). None of the 9 topics was statistically significant different based on physician involvement in PM.
Discussion
Building a successful medical practice has become more difficult for graduating orthopedic surgery residents because of an increasingly complex health care system, shrinking reimbursement rates, and looming regulatory changes. These challenges have reinforced the importance of teaching residents the necessary PM knowledge and skills to function effectively in a medical practice. Multiple studies from different specialties surveying or testing graduating residents and young practicing physicians on their business management knowledge or specific business topics have shown severe deficiencies.5-11 Unfortunately, graduating orthopedic surgery residents also appear inadequately prepared in PM. In a study of resident coding/billing knowledge, Gill and Schutt6 surveyed 2006 graduating orthopedic residents and found that only 13% felt confident in their coding ability. Our study results add to our understanding of multiple PM topics and demonstrate graduating orthopedic residents’ deficiencies throughout these topics.
Increased efforts to develop business management training programs and curricula have helped improve both overall PM and business knowledge in other specialties.12-15 ACGME now requires 100 hours of PM training among family medicine residency programs.16 A curriculum instituted in a general surgery residency focused on improving coding found that accuracy improved from 36% to 88% over 12 months.13 A family practice residency instituted a “simulated practice” model for its residents to improve practical PM learning and found statistically significant improvement over their prior didactic lectures.15 However, there continues to be significant variability in the topics and methods covered in business management curricula as programs struggle to determine how to most effectively use their limited time to prepare graduating residents.
In this study, we introduced the concept of FKD. With limited time available for teaching business knowledge and PM skills in residency, it has become imperative that training be efficient and effective. The FKD model can improve training efficiency by directing training to the topics that will produce the highest yield in preparing physicians for practice. As our results demonstrate, topics with the lowest levels of knowledge among surgeons often are not the same as the topics that are most needed to function effectively in practice (Table 3). The FKD model identifies deficiencies in practical, applicable knowledge rather than focusing on a general knowledge level. We suspect that focusing on topics with a high FKD would provide a higher yield in preparing physicians for practice. As such, our results suggest that training in business operations and coding/billing would likely provide the highest practical value, despite the fact that these were not the areas of least general knowledge.
Another finding of this study was the FKD difference based on type of practice. Compared with private practice physicians, hospital-employed or academic physicians had substantially lower overall FKDs and significantly lower FKDs in several specific topics. However, these FKD differences exist despite minimal differences in overall levels of knowledge. This would suggest that less business knowledge was needed by physicians to enter these types of practices compared with traditional private practice. We speculate that this may be one factor influencing the recent trend by graduating orthopedic residents to take hospital-employed positions, as these positions may appear less demanding in terms of learning the management aspects of the new practice.
Our results also showed slightly higher reported average business knowledge and lower FKD reported by those who had recently completed training (within 2-5 years) versus those in practice much longer. This is particularly interesting, as our institution has maintained the same lecture-based program for many years without significant changes. Although these differences may not be statistically significant, they may reflect an increased interest in and attention to learning PM skills while in training. However, we acknowledge this is only one of many possible explanations for these findings.
This study had several limitations. First, all respondents were graduates of a single institution. We were trying to limit the variability in business training, but this also limits the scope of the results. Second, self-ratings on surveys provide subjective measures of business knowledge and functional knowledge. Scores may vary based on individuals’ understanding of given topics, or they may inaccurately represent their level of understanding. This is especially true of respondents who graduated from residency, for example, 20 years earlier—their survey responses may reflect erroneous recollection of business training at time of graduation compared with respondents who graduated more recently. Conversely, more recent graduates may not have a fully formed or accurate picture of how much business knowledge is required to function in practice. Nevertheless, we found no significant differences in measured parameters based on graduation date, so we chose not to exclude older respondents, which also may have weakened our data pool. Further, FKDs are relative values used to compare subjective deficiencies rather than absolute scores of specific general knowledge. As such, subjectivity, including recollection of business training, is inherent in the model used in this study.
Conclusion
Graduating orthopedic surgeons currently appear inadequately prepared to effectively manage business issues in their practices, as evidenced by their low overall knowledge levels and high FKDs. The novel FKD model described in this study helps define FKD levels and identify topics that may provide the highest yield in improving effectiveness in practice. Residency curricula focused on improving business and PM knowledge, particularly in the topics with the highest FKDs (eg, business operations, coding/billing), may improve training efficiency in these areas. Further studies with larger numbers of physicians across multiple institutions are needed to confirm these findings and to validate the FKD concept.
With the increasing complexity of health care policy, significant changes in reimbursement and payer sources, and constant push to improve the cost-efficiency of care delivery, there has been a growing focus on the importance of business knowledge and practice management (PM) skills among physicians. Family medicine was the first specialty to require PM training during residency; other specialities have begun implementing business training into their residency curriculum.1 In 1999, the Accreditation Council for Graduate Medical Education (ACGME) identified 6 core competencies that should be included in resident training. One of these core competencies involves training in health care systems and PM.2,3
Residency program directors have also recognized the need for business training among residents. One study that surveyed general surgery program directors found that more than 87% agreed that residents should be trained in business and PM.4 Although these directors recognized the need for training, they also acknowledged the current deficiency: more than 70% thought their current trainees were inadequately trained in business and PM. Similarly, residents and physicians in multiple specialties have reported significant deficiencies in their training and knowledge of PM and business principles.5-11 For example, in a recent survey of ophthalmologists who had been in practice less than 5 years, 70% reported being not very well or not at all trained in overall PM skills during residency.5 Yet, most respondents thought training in this area was the responsibility of the training program.
The call for more business and PM training during residency has been tempered by increasing demands on medical and surgical skills training and time limitations such as duty-hour restrictions. These limitations reinforce the need to find efficient and effective means of teaching necessary business knowledge and PM skills. Paramount to doing this is recognizing the difference between general knowledge and functional knowledge—essentially, what is specifically needed to function effectively in practice.
We conducted a study not only to determine the general level of knowledge that physicians have in different business and PM topics when they complete their residency, but also to evaluate the level of knowledge that graduating physicians need in different business and PM topics in order to function effectively in a medical practice. Toward this end, we developed a novel model that could help determine the level of the functional knowledge deficiency (FKD) of particular business topics. We thought this model would allow us to quantify how much knowledge physicians needed to acquire in a given topic in order to function effectively in practice. We hypothesized that graduating residents would report overall low levels of business knowledge and high FKDs.
Materials and Methods
To minimize variability in the specific type and amount of business training received, we focused this study on a single institution that had maintained a uniform business management curriculum over an extended period. The business training program provided to residents in the orthopedic surgery residency at this institution included 6 hours of didactic lectures on various business topics annually. This program has been in place for more than 15 years and has not undergone any significant changes during that time.
Using the program’s alumni directory, we emailed a cover letter and an 11-question survey to all 332 residents and fellows who had completed their residency or fellowship training at our institution between 1970 and 2008. Anyone who did not reply to the email was mailed a copy of the cover letter and the survey.
The first 4 survey questions involved the demographics of the surgeon and the surgeon’s practice. Subsequent questions focused on the surgeon’s understanding of 9 different general business and PM topics and their importance in the practice. The topics were marketing, business operations, human resources, contract negotiations, malpractice issues, coding/billing, medical records management, accounting, and economic analytical tools. The surgeon was asked to use a 10-point scale ranging from 1 (“knew nothing at all”) to 10 (“complete understanding”) to rate his or her understanding of each topic at the completion of residency. The surgeon was also asked to rate how important it was to understand that topic in the surgeon’s current practice. Again, a 10-point scale was used: 1 (“not important at all”) to 10 (“absolutely vital”) (Figure).
When the surveys were returned, their data were compiled and analyzed to determine the overall knowledge levels for each topic and the levels based on years in practice, type of practice, and level of involvement in PM. We also wanted to determine the amount of business knowledge that they needed in order to function effectively in practice (and that they lacked at time of graduation). We defined this as the FKD at graduation and calculated it as the difference between the surgeon’s reported importance of a topic in his or her current practice and his or her level of understanding of that topic at graduation. A larger FKD score represented greater deficiency, with a maximal possible FKD score of 9. A score of 0 would reflect an appropriate amount of knowledge to function effectively, and a negative score would reflect a knowledge surplus. Using the demographic information from the survey, we were then able to further analyze the levels of overall knowledge as well as the FKD for each topic with respect to length of time in practice, type of practice, and the surgeon’s involvement in PM.
We evaluated the reported levels of knowledge based on both type of practice (academic, hospital-employed, private practice) and who managed the practice (physician, nonphysician). Academic practices were defined as those associated with an academic medical center; hospital-employed practices were those in which the physician was an employee of a health system not associated with an academic medical center; and private practices were defined as physician-owned orthopedic practices not associated with an academic medical center. Regarding management, practices in which physicians were primarily responsible for the daily operations of the practice were considered physician-managed; conversely, practices in which operations were controlled by either employed or institutionally assigned administration were defined as nonphysician-managed.
Statistical analysis of the results for different practice types and levels of involvement in management was performed for both general knowledge and FKD. Means, medians, and standard deviations were calculated. One-way analysis of variance or t tests were then used to examine mean differences overall and within each business topic. When a difference was found, a post hoc Tukey multiple range test was performed to identify it. Differences at P < .05 were considered significant.
Results
One hundred eighty-two surgeons answered the survey, yielding a response rate of 55%. All had completed their training at our institution. Seven respondents were removed from the study because they had retired from practice (5) or had returned incomplete surveys (2).
The overall self-rated level of business knowledge of all responding surgeons at the conclusion of their training was 2.4 on the 10-point scale (Table 1). Specifically, physicians reported the lowest levels of business understanding in economic analytical tools (1.5), human resources (1.7), and contract negotiations (1.9), suggesting minimal knowledge of these topics generally. They reported the highest levels of knowledge in medical records management (3.8) and malpractice issues (3.3). Even these topics, however, still reflected overall low levels of knowledge.
There was no statistically significant difference between private practice and academic physicians. In addition, surgeons in physician-managed practices reported significantly (P = .045) higher levels of understanding of economic analytical tools than surgeons in nonphysician-managed practices (Table 1). There were no other statistically significant differences among groups.
The overall calculated FKD for all surgeons was 5.6. FKDs were calculated for all 9 business topics. The worst FKDs were in business operations (6.4) and coding/billing (6.3). The topic with the least deficiency (lowest FKD) was in medical records management (4.2) (Table 2).
Surgeons’ FKDs based on practice type (academic, hospital-employed, private practice) were compared to identify potentially significant differences. Hospital-employed physicians had the lowest overall FKD (4.0), followed by physicians in academic practices (5.1) and private practices (5.9). Hospital-employed physicians reported statistically significantly better (lower) FKDs in comparison with physicians in private practice in multiple topics, including human resources, contract negotiations, malpractice issues, coding/billing, and accounting (Table 2). Similarly, physicians in academic practices also had statistically significantly better FKDs than physicians in private practice in the topics of business operations, contract negotiations, and billing/coding. Compared with hospital-employed physicians, physicians in academic practices had significantly more knowledge about marketing, business operations, and accounting. Physicians in private practice did not have significantly better FKDs in any topic in comparison with hospital-employed or academic physicians. There was no significant difference in FKDs for medical records management or economic analytical tools based on practice type.
Comparisons based on PM involvement showed that physicians in practices with nonphysician management had only a slightly better FKD (5.6) at graduation than those in practices with physician involvement (5.7). None of the 9 topics was statistically significant different based on physician involvement in PM.
Discussion
Building a successful medical practice has become more difficult for graduating orthopedic surgery residents because of an increasingly complex health care system, shrinking reimbursement rates, and looming regulatory changes. These challenges have reinforced the importance of teaching residents the necessary PM knowledge and skills to function effectively in a medical practice. Multiple studies from different specialties surveying or testing graduating residents and young practicing physicians on their business management knowledge or specific business topics have shown severe deficiencies.5-11 Unfortunately, graduating orthopedic surgery residents also appear inadequately prepared in PM. In a study of resident coding/billing knowledge, Gill and Schutt6 surveyed 2006 graduating orthopedic residents and found that only 13% felt confident in their coding ability. Our study results add to our understanding of multiple PM topics and demonstrate graduating orthopedic residents’ deficiencies throughout these topics.
Increased efforts to develop business management training programs and curricula have helped improve both overall PM and business knowledge in other specialties.12-15 ACGME now requires 100 hours of PM training among family medicine residency programs.16 A curriculum instituted in a general surgery residency focused on improving coding found that accuracy improved from 36% to 88% over 12 months.13 A family practice residency instituted a “simulated practice” model for its residents to improve practical PM learning and found statistically significant improvement over their prior didactic lectures.15 However, there continues to be significant variability in the topics and methods covered in business management curricula as programs struggle to determine how to most effectively use their limited time to prepare graduating residents.
In this study, we introduced the concept of FKD. With limited time available for teaching business knowledge and PM skills in residency, it has become imperative that training be efficient and effective. The FKD model can improve training efficiency by directing training to the topics that will produce the highest yield in preparing physicians for practice. As our results demonstrate, topics with the lowest levels of knowledge among surgeons often are not the same as the topics that are most needed to function effectively in practice (Table 3). The FKD model identifies deficiencies in practical, applicable knowledge rather than focusing on a general knowledge level. We suspect that focusing on topics with a high FKD would provide a higher yield in preparing physicians for practice. As such, our results suggest that training in business operations and coding/billing would likely provide the highest practical value, despite the fact that these were not the areas of least general knowledge.
Another finding of this study was the FKD difference based on type of practice. Compared with private practice physicians, hospital-employed or academic physicians had substantially lower overall FKDs and significantly lower FKDs in several specific topics. However, these FKD differences exist despite minimal differences in overall levels of knowledge. This would suggest that less business knowledge was needed by physicians to enter these types of practices compared with traditional private practice. We speculate that this may be one factor influencing the recent trend by graduating orthopedic residents to take hospital-employed positions, as these positions may appear less demanding in terms of learning the management aspects of the new practice.
Our results also showed slightly higher reported average business knowledge and lower FKD reported by those who had recently completed training (within 2-5 years) versus those in practice much longer. This is particularly interesting, as our institution has maintained the same lecture-based program for many years without significant changes. Although these differences may not be statistically significant, they may reflect an increased interest in and attention to learning PM skills while in training. However, we acknowledge this is only one of many possible explanations for these findings.
This study had several limitations. First, all respondents were graduates of a single institution. We were trying to limit the variability in business training, but this also limits the scope of the results. Second, self-ratings on surveys provide subjective measures of business knowledge and functional knowledge. Scores may vary based on individuals’ understanding of given topics, or they may inaccurately represent their level of understanding. This is especially true of respondents who graduated from residency, for example, 20 years earlier—their survey responses may reflect erroneous recollection of business training at time of graduation compared with respondents who graduated more recently. Conversely, more recent graduates may not have a fully formed or accurate picture of how much business knowledge is required to function in practice. Nevertheless, we found no significant differences in measured parameters based on graduation date, so we chose not to exclude older respondents, which also may have weakened our data pool. Further, FKDs are relative values used to compare subjective deficiencies rather than absolute scores of specific general knowledge. As such, subjectivity, including recollection of business training, is inherent in the model used in this study.
Conclusion
Graduating orthopedic surgeons currently appear inadequately prepared to effectively manage business issues in their practices, as evidenced by their low overall knowledge levels and high FKDs. The novel FKD model described in this study helps define FKD levels and identify topics that may provide the highest yield in improving effectiveness in practice. Residency curricula focused on improving business and PM knowledge, particularly in the topics with the highest FKDs (eg, business operations, coding/billing), may improve training efficiency in these areas. Further studies with larger numbers of physicians across multiple institutions are needed to confirm these findings and to validate the FKD concept.
1. Rose EA, Neale AV, Rathur WA. Teaching practice management during residency. Fam Med. 1999;31(2):107-113.
2. Accreditation Council for Graduate Medical Education. ACGME common program requirements. http://www.acgme.org/acgmeweb/Portals/0/PFAssets/ProgramRequirements/CPRs2013.pdf. Updated June 9, 2013. Accessed August 25, 2015.
3. Itani K. A positive approach to core competencies and benchmarks for graduate medical education. Am J Surg. 2002;184(3):196-203.
4. Lusco VC, Martinez SA, Polk HC Jr. Program directors in surgery agree that residents should be formally trained in business and practice management. Am J Surg. 2005;189(1):11-13.
5. McDonnell PJ, Kirwan TJ, Brinton GS, et al. Perceptions of recent ophthalmology residency graduates regarding preparation for practice. Ophthalmology. 2007;114(2):387-391.
6. Gill JB, Schutt RC Jr. Practice management education in orthopaedic surgical residencies. J Bone Joint Surg Am. 2007;89(1):216-219.
7. Satiani B. Business knowledge in surgeons. Am J Surg. 2004;188(1):13-16.
8. Cantor JC, Baker LC, Hughes RG. Preparedness for practice. Young physicians’ views of their professional education. JAMA. 1993;270(9):1035-1040.
9. Fakhry SM, Robinson L, Hendershot K, Reines HD. Surgical residents’ knowledge of documentation and coding for professional services: an opportunity for a focused educational offering. Am J Surg. 2007;194(2):263-267.
10. Williford LE, Ling FW, Summitt RL Jr, Stovall TG. Practice management in obstetrics and gynecology residency curriculum. Obstet Gynecol. 1999;94(3):476-479.
11. Andreae MC, Dunham K, Freed GL. Inadequate training in billing and coding as perceived by recent pediatric graduates. Clin Pediatr. 2009;48(9):939-944.
12. Kolva DE, Barzee KA, Morley CP. Practice management residency curricula: a systematic literature review. Fam Med. 2009;41(6):411-419.
13. Jones K, Lebron RA, Mangram A, Dunn E. Practice management education during surgical residency. Am J Surg. 2008;196(6):878-881.
14. Kerfoot BP, Conlin PR, Travison T, McMahon GT. Web-based education in systems-based practice: a randomized trial. Arch Intern Med. 2007;167(4):361-366.
15. LoPresti L, Ginn P, Treat R. Using a simulated practice to improve practice management learning. Fam Med. 2009;41(9):640-645.
16. Accreditation Council for Graduate Medical Education. Family medicine program requirements. https://www.acgme.org/acgmeweb/tabid/132/ProgramandInstitutionalAccreditation/MedicalSpecialties/FamilyMedicine.aspx. Accessed September 23, 2015.
1. Rose EA, Neale AV, Rathur WA. Teaching practice management during residency. Fam Med. 1999;31(2):107-113.
2. Accreditation Council for Graduate Medical Education. ACGME common program requirements. http://www.acgme.org/acgmeweb/Portals/0/PFAssets/ProgramRequirements/CPRs2013.pdf. Updated June 9, 2013. Accessed August 25, 2015.
3. Itani K. A positive approach to core competencies and benchmarks for graduate medical education. Am J Surg. 2002;184(3):196-203.
4. Lusco VC, Martinez SA, Polk HC Jr. Program directors in surgery agree that residents should be formally trained in business and practice management. Am J Surg. 2005;189(1):11-13.
5. McDonnell PJ, Kirwan TJ, Brinton GS, et al. Perceptions of recent ophthalmology residency graduates regarding preparation for practice. Ophthalmology. 2007;114(2):387-391.
6. Gill JB, Schutt RC Jr. Practice management education in orthopaedic surgical residencies. J Bone Joint Surg Am. 2007;89(1):216-219.
7. Satiani B. Business knowledge in surgeons. Am J Surg. 2004;188(1):13-16.
8. Cantor JC, Baker LC, Hughes RG. Preparedness for practice. Young physicians’ views of their professional education. JAMA. 1993;270(9):1035-1040.
9. Fakhry SM, Robinson L, Hendershot K, Reines HD. Surgical residents’ knowledge of documentation and coding for professional services: an opportunity for a focused educational offering. Am J Surg. 2007;194(2):263-267.
10. Williford LE, Ling FW, Summitt RL Jr, Stovall TG. Practice management in obstetrics and gynecology residency curriculum. Obstet Gynecol. 1999;94(3):476-479.
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