Journal of Clinical Outcomes Management

From the U.S. Department of Veterans Affairs (all authors), and Cognosante, LLC, Falls Church, VA (Dr. Murray, Dr. Sawyer, and Jessica Fankhauser).

Abstract

Objective: The COVID-19 pandemic posed unprecedented leadership challenges to health care organizations worldwide, especially those on the journey to high reliability. The objective of this pilot quality improvement initiative was to describe the experiences of medical center leaders continuing along the journey to high reliability during the pandemic.

Methods: A convenience sample of Veterans Health Administration medical center directors at facilities that had initiated the journey to high reliability prior to or during the COVID-19 pandemic were asked to complete a confidential survey to explore the challenges experienced and lessons learned.

Results: Of the 35 potential participants, 15 completed the confidential web-based survey. Five major themes emerged from participants’ responses: (1) managing competing priorities, (2) staying committed, (3) adapting and overcoming, (4) prioritizing competing demands, and (5) maintaining momentum.

Conclusion: This pilot quality improvement initiative provides some insight into the challenges experienced and lessons learned during the COVID-19 pandemic to help inform health care leaders’ responses during crises they may encounter along the journey to becoming a high reliability organization.

Keywords: HRO, leadership, patient safety.

Health care leaders worldwide agree that the COVID-19 pandemic has presented one of the most challenging leadership tests encountered in many generations,^1,2 creating a widespread crisis of unprecedented scope and scale for health care systems globally.^2,3 COVID-19 has posed many challenges and obstacles for health care leaders, including overworked, overstressed, and socially isolated employees; expedited hiring to ensure adequate staffing; reallocation of employees to other units; supply shortages such as personal protective equipment; changing polices related to safety protocols; modifying operations; reorganizing facilities to care for large volumes of critically ill patients; and ethical challenges.^4-8 Health care systems were required to create and implement new clinical, operational, and staffing protocols that extended capabilities far beyond conventional standards of care and crisis response operations.⁹ To provide a picture of the impact of COVID-19 on the Veterans Health Administration (VHA), as of March 3, 2023, the VHA has fully vaccinated more than 4.7 million individuals, including 4.3 million veterans and 320,936 federal employees.^10,11

Maintaining continuous progress toward advancing high reliability organization (HRO) principles and practices can be especially challenging during crises of unprecedented scale such as the pandemic. HROs must be continually focused on achieving safety, quality, and efficiency goals by attending to the 3 pillars of HRO: culture, leadership, and continuous process improvement. HROs promote a culture where all staff across the organization watch for and report any unsafe conditions before these conditions pose a greater risk in the workplace. Hospital leaders, from executives to frontline managers, must be cognizant of all systems and processes that have the potential to affect patient care.¹² All of the principles of HROs must continue without fail to ensure patient safety; these principles include preoccupation with failure, anticipating unexpected risks, sensitivity to dynamic and ever-changing operations, avoiding oversimplifications of identified problems, fostering resilience across the organization, and deferring to those with the expertise to make the best decisions regardless of position, rank, or title.^12,13 Given the demands faced by leaders during crises with unprecedented disruption to normal operating procedures, it can be especially difficult to identify systemic challenges and apply lessons learned in a timely manner. However, it is critical to identify such lessons in order to continuously improve and to increase preparedness for subsequent crises.^13,14

Because of the COVID-19 pandemic’s unprecedented nature in recent history, a review of the literature produced little evidence exploring the challenges experienced and lessons learned by health care leaders, especially as it relates to implementing or sustaining HRO journeys during the COVID-19 pandemic. Related literature published to date consists of editorials on reliability, uncertainty, and the management of errors¹⁵; patient safety and high reliability preventive strategies¹⁶; and authentic leadership.¹⁷ Five viewpoints were published on HROs and maladaptive stress behaviors,¹⁸ mindful organizing and organizational reliability,¹⁹ the practical essence of HROs,²⁰ embracing principles of HROs in crisis,⁸ and using observation and high reliability strategies when facing an unprecedented safety threat.²¹ Finally, the authors identified 2 studies that used a qualitative research approach to explore leadership functions within an HRO when managing crises²² and organizational change in response to the COVID-19 pandemic.²³ Due to the paucity of available information, the authors undertook a pilot quality improvement (QI) initiative to address this knowledge gap.

The aim of this initiative was to gain a better understanding of the challenges experienced, lessons learned, and recommendations to be shared by VHA medical center directors (MCDs) of health care facilities that had initiated the journey to high reliability before or during the COVID-19 pandemic. The authors hope that this information will help health care leaders across both governmental and nongovernmental organizations, nationally and globally, to prepare for future pandemics, other unanticipated crises (eg, natural disasters, terrorist attacks), and major change initiatives (eg, electronic health record modernization) that may affect the delivery of safe, high-quality, and effective patient care. The initiative is described using the SQUIRE 2.0 guidelines.^24,25

Methods

Survey

We used a qualitative approach and administered a confidential web-based survey, developed by the project team, to VHA MCDs at facilities that had initiated the journey to high reliability before or during the COVID-19 pandemic. The survey consisted of 8 participant characteristic questions (Table 1) and 4 open-ended questions. The open-ended questions were designed to encourage MCD participants to freely provide detailed descriptions of the challenges experienced, lessons learned, recommendations for other health care leaders, and any additional information they believed was relevant.^26,27 Participants were asked to respond to the following items:

1. Please describe any challenges you experienced while in the role of MCD at a facility that initiated implementation of HRO principles and practices prior to (February 2020) or during (March 2020–September 2021) the initial onset of the COVID-19 pandemic.

1. What are some lessons that you learned when responding to the COVID-19 pandemic while on the journey to high reliability?
2. What recommendations would you like to make to other health care leaders to enable them to respond effectively to crises while on the journey to high reliability?
3. Please provide any additional information that would be of value.

An invitation to participate in this pilot QI initiative was sent via e-mail to 35 potential participants, who were all MCDs at Cohort 1 and Cohort 2 facilities. The invitation was sent on June 17, 2022, by a VHA senior High Reliability Enterprise Support government team member not directly involved with the initiative. The participants were given 3 weeks to complete the survey. A reminder was sent at the end of week 1 and the beginning of week 3. The VHA MCDs from Cohort 1 (n = 17) began the HRO journey in February 2019 and those in Cohort 2 (n = 18) initiated the HRO journey in October 2020. Because the VHA is the largest integrated health care system in the United States, the potential participants were geographically dispersed. Examples of locations in Cohort 1 include Manchester Veterans Affairs Medical Center (VAMC) in New Hampshire, Ralph H. Johnson VAMC in Charleston, South Carolina, and Boise VAMC, in Idaho. Examples of Cohort 2 locations include Chillicothe VAMC in Ohio, Marion VAMC in Indiana, and John D. Dingell VAMC in Detroit, Michigan.

The invitation included the objective of the initiative, estimated time to complete the confidential web-based survey, time allotted for responses to be submitted, and a link to the survey should potential participants agree to participate. Potential participants were informed that their involvement was voluntary, based on their willingness to participate and available time to complete the survey. Finally, the invitation noted that any comments provided would remain confidential and nonattributional for the purpose of publishing and presenting. The inclusion criteria for participation were: (1) serving in the role of MCD of an organization that initiated implementation of HRO principles and practices prior to (February 2020) or during (March 2020–September 2021) the initial onset of the COVID-19 pandemic; (2) voluntary participation; and (3) thorough responses provided to the 4 open-ended and 8 participant characteristic questions, according to the instructions provided.

Data Gathering and Analysis

To minimize bias and maintain neutrality at the organizational level, only non-VHA individuals working on the project were directly involved with participants’ data review and analysis. Participant characteristics were analyzed using descriptive statistics. Responses to the 4 open-ended questions were coded and analyzed by an experienced researcher and coauthor using NVivo 11 qualitative data analysis software.²⁸ To ensure trustworthiness (credibility, transferability, dependability, and confirmability) in the data analysis procedure,²⁹ inductive thematic analysis was also performed manually using the methodologies of Braun and Clarke (Table 2)³⁰ and Erlingsson and Brysiewicz.³¹ The goal of inductive analysis is to allow themes to emerge from the data while minimizing preconceptions.^32,33 Regular team meetings were held to discuss and review the progress of data collection and analysis. The authors agreed that the themes were representative of the participants’ responses.

Institutional review board (IRB) review and approval were not required, as this project was a pilot QI initiative. The intent of the initiative was to explore ways to improve the quality of care delivered in the participants’ local care settings and not to generalize the findings. Under these circumstances, formal IRB review and approval of a QI initiative are not required.³⁴ Participation in this pilot QI initiative was voluntary, and participants could withdraw at any time without consequences. Completion of the survey indicated consent. Confidentiality was ensured at all times by avoiding both the use of facility names and the collection of participant identifiers. Unique numbers were assigned to each participant. All comments provided by survey participants remained confidential and nonattributional for the purpose of publishing and presenting.

Results

Of the 35 potential participants, 15 VHA MCDs (43%) completed the confidential web-based survey. Out of the 17 potential participants in Cohort 1, 6 (35%) completed the survey. With Cohort 2, 9 (50%) of the potential 18 participants responded. Although saturation was reached at 10 responses, the additional completed surveys were included in the analysis. Saturation can be achieved with a small number of participants (n = 9–17), particularly when the potential participants are relatively homogenous and project aims are narrowly defined.³⁵ Most participants had more than 10 years of executive-level experience and most medical centers had been on the journey to high reliability for more than 12 months at the time of the pandemic (Table 3). Five major themes emerged from the participants’ responses: (1) managing competing priorities, (2) staying committed, (3) adapting and overcoming, (4) prioritizing competing demands, and (5) maintaining momentum. In the following sections, the numbers in parentheses after the direct quotes represent the unique numbers assigned to the participant providing the response.

Managing Competing Priorities

When analyzing the responses to question 1, a recurring theme from 7 participants (Cohort 1, n = 4; Cohort 2, n = 3) related to challenges encountered while continuing the journey to high reliability during COVID-19 was managing competing priorities. Although most participants reported extensive previous leadership experience, some did not feel prepared for the complexity, uncertainty, challenges, and multitude of competing priorities facing the journey to high reliability during the COVID-19 pandemic. One participant succinctly noted:

“There were too many competing priorities dealing with the pandemic and staffing crisis.” (Participant 8)

Other participants shared:

“We had our HRO mentor designated just as our first peak was descending on us. It was initially challenging to determine the proper pace of implementation when we clearly had other things going on. There was a real risk that people would say, ‘What, are you kidding?’ as we tried to roll this out.” (Participant 4)

“Prior to COVID, our main challenges were getting organized and operational rollout. During the pandemic, we had to shift our focus to COVID and the training aspects suffered. Also, many other priorities pulled us away from an HRO rollout focus.” (Participant 6)

Staying Committed

When examining the question 2 responses, 1 theme that resonated most when it came to lessons learned, shared by 6 participants (Cohort 1, n = 4; Cohort 2, n = 2), was the need to stay committed to HRO, despite the unprecedented crisis at hand. A number of participants eloquently noted how important it was stay committed to the HRO journey during the COVID-19 pandemic:

“If you don’t need a highly reliable organization during a crisis, when do you need it? That was the message that we kicked off with. It was also VERY important to take things slowly. Education had to be done in bits, and we had a much more modest timeline than what would have been the norm for any initiative pre-COVID. The emphasis was on this being a long-term commitment, that we would be doing it the right way rather than rushing it, etc.” (Participant 4)

“Keeping HRO principles and a Just Culture on the forefront of our minds, we looked for opportunities to progress on our HRO journey, despite the challenges of the pandemic. Our monthly Town Halls became weekly events to share COVID updates and information with staff. We used the Town Halls to promote our HRO mission and to open communication lines with staff, designating 1 week each month as a ‘Safety Forum.’ The pandemic provided the springboard and backdrop for staff Safety Stories submissions, many of which were shared at our Town Halls and Safety Forums.” (Participant 7)

“We were able to utilize HRO principles in response to the COVID pandemic. Specifically standardized communication from the facility to VISN [Veterans Integrated Services Network] was initiated on a daily basis. This practice provided daily communication on key operational items and clinical items at the medical center, allowed timely feedback on actions being taken, as was instrumental in daily checks on staffing, COVID testing supplies, overall supply chain issues.” (Participant 9)

Adapting and Overcoming

The recommendations provided by 10 participants (Cohort 1, n = 6; Cohort 2, n = 4) for other health care leaders experiencing a crisis during the journey to high reliability were insightful. The themes that frequently emerged from the responses to the survey were to adapt and overcome. Participants shared:

“Utilize the many tools you’re given, specifically your team. Try even the craziest ideas from frontline staff.” (Participant 1)

“Use your mentors for younger directors and, even if you think you know the answer, involve your staff. It makes them feel they have a voice and gives them ownership of the issues.” (Participant 5)

“Make sure that you have key leaders in place who are committed to HRO and can help the organization adjust.” (Participant 6)

“Take advantage of HRO Leader Coaching, which pairs MCDs with coaches who act as consultants for HRO leadership practices to ensure progress in reaching the next level in the journey to High Reliability.” (Participant 7)

“Meet regularly with the HRO Lead and team (more frequently during early stages of implementation) to provide support, eliminate barriers, and champion the HRO mission. It is important to include other members of the ELT [Executive Leadership Team] to ensure their involvement with the facility HRO strategic plan.” (Participant 7)

“Prioritize and understand that not everything is priority #1. Continue what you can with HRO, incorporate high reliability principles into the work being done during a crisis, but understand you may need to modify rollout schedules.” (Participant 8)

Prioritizing Competing Demands

The theme of prioritizing competing demands emerged again from 5 participants (Cohort 1, n = 3; Cohort 2, n = 2) with question 3 describing recommendations for other leaders:

“Your first priority is to the crisis. Don’t get distracted by this or any other initiative. That was not a very popular message for the people pushing HRO, but it is the reality and the necessity. However, it IS possible to move forward with HRO (or other important initiatives) during crisis times, as long as you carefully consider what you are asking of people and don’t overload/overwhelm them. It is not your ego (or that of Central Office) that needs to be stoked. If the initiative truly has value, you need to be patient to see it done properly, rather than rushed/pushed/forced. Don’t kill it by being overeager and overwhelming your already overtaxed people. That said, keep moving forward. The key is pacing—and remember that your Type A hard-driving leader types (you know who you are) will certainly fail if they push it. Or even if they go at a normal pace that would be appropriate for noncrisis times.” (Participant 4)

“Prioritize and understand that not everything is priority #1. Continue what you can with HRO, incorporate high reliability principles into the work being done during a crisis, but understand you may need to modify rollout schedules.” (Participant 8)

“It was critical for us to always focus on the immediate workplace safety of staff (especially those on the frontlines of the pandemic response) when in the process of rolling out HRO initiatives.” (Participant 14)

Maintaining Momentum

When analyzing additional information that participants thought would be of value, 3 participants (Cohort 1, n=2; Cohort 2, n=1) noted the importance of maintaining momentum with HRO during a crisis:

“It seemed as though communication and education from VHA on HRO slowed down at the same time, which further slowed our progress. We are now trying to ramp our engagement up again.” (Participant 3)

“There can be synergy between crisis response and HRO implementation. As an example, one of the first steps we took was leadership rounding. That was necessary anyways for crisis management (raising the spirits on the front lines, so to speak). What we did was include scheduled time instead of (in addition to) ad hoc. And we got credit for taking an HRO step. I resisted whiteboards/visual management systems for a long time because (in my opinion) that would have been much too distracting during the crisis. Having waited for better times, I was able to move forward with that several months later and with good success.” (Participant 4)

Discussion

Health care leaders worldwide experienced an immense set of challenges because of the COVID-19 pandemic, which is a crisis of a magnitude with no parallel in modern times. Strong, adaptive leadership at all levels of health care systems was needed to effectively address the immense crisis at hand.^36,37 Findings from this pilot QI initiative suggest that MCDs faced many new challenges, requiring them to perform unfamiliar tasks and manage numerous overlapping challenges (eg, staffing shortages and reassignments, safety concerns, changes to patient appointments, backlogs in essential services), all while also trying to continue with the journey to high reliability. Despite the challenges leaders faced, they recognized the need to manage competing priorities early and effectively. At times, the priority was to address the wide-ranging, urgent issues related to the pandemic. When the conditions improved, there was time to refocus efforts on important but longer-term activities related to the HRO journey. Other participants recognized that their commitment to HRO needed to remain a priority even during the periods of intense focus on COVID-19. These participants continuously looked for ways to integrate HRO principles and practices into their response to the extraordinary challenges of the pandemic. Emerging research highlights how leaders had to modify their day-to-day responsibilities because of the wide disruptions caused by the COVID-19 pandemic, even when not on the journey to becoming an HRO.^36,37

Some participants felt compelled to stay committed to the HRO journey despite numerous competing demands. They stayed committed to looking for opportunities to progress by implementing HRO principles and practices to achieve safety, quality, and efficiency goals. This dedication is noteworthy, especially in light of recently published research that demonstrates the vast number of patient safety issues that presented during the COVID-19 pandemic (eg, ineffective communication, poor teamwork, the absence of coordination)¹ as well as perceptions that patient safety and quality of care had significantly declined as a result of the crisis.^36,37

Participants also highlighted the need to be adaptive when responding to the complexity and unpredictability of the pandemic. Participants regularly sought ways to increase their knowledge, skills, and abilities by using the resources (eg, tools, experts) available to them. Research shows that in increasingly complex and ever-changing situation such as the COVID-19 pandemic, leaders must be adaptive with all levels of performance, especially when limited information is available.^38,39

This is the first initiative of its kind to specifically explore the challenges experienced and lessons learned from health care leaders continuing along the journey to high reliability during the COVID-19 pandemic. Findings from this pilot QI initiative revealed that many participants recommended that leaders adapt and overcome challenges as much as possible when continuing with HRO during a crisis. These findings are echoed in the current literature suggesting that adaptive performance is a highly effective form of leadership during crises.^38,40 Being able to effectively adapt during a crisis is essential for reducing further vulnerabilities across health care systems. In fact, this lesson is shared by many countries in response to the unprecedented global crisis.⁴¹A limitation of this pilot QI initiative is that the authors did not directly solicit responses from all VHA MCDs or from other health care executives (eg, Chief of Staff, Associate Director for Operations, Associate Director for Patient Care, and Nurse Executive). As such, our findings represent only a small segment of senior leadership perspectives from a large, integrated health care system. Individuals who did not respond to the survey may have had different experiences than those who did, and the authors excluded many MCDs who formally began their HRO journeys in 2022, well after the pandemic was underway. Similarly, the experiences of Veterans Affairs leaders may or may not be similar to that of other health care organizations. Although the goal of this initiative was to explore the participants’ experiences during the period of crisis, time and distance from the events at the height of the COVID-19 pandemic may have resulted in difficulty recalling information as well as making sense of the occurrence. This potential recall bias is a common occurrence in trying to explore past experiences, especially as they relate to crises. Finally, this pilot QI initiative did not explore personal challenges participants may have faced during this period of time (eg, burnout, personal or family illness), which may have also shaped their responses.

Conclusion

This initiative suggests that VHA MCDs often relied on HRO principles to guide and assist with their response to the COVID-19 pandemic, including managing periods of unprecedented crisis. The ability to adapt and prioritize was seen as an especially important lesson. Many MCDs continued their personal and organizational efforts toward high reliability even in periods of intense challenge because of the pandemic. These findings can help with future crises that may occur during an organization’s journey to high reliability. This pilot QI initiative’s findings warrant further investigation to explore the experiences of the broader range of health care leaders while responding to unplanned crises or even planned large-scale cultural change or technology modernization initiatives (eg, electronic health record modernization) to expand the state of the science of high reliability as well as inform policy and decision-making. Finally, another area for future study is examining how leadership responses vary across facilities, depending on factors such as leader roles, facility complexity level, resource availability, patient population characteristics, and organizational culture.

Acknowledgment: The authors express their sincere gratitude to the medical center directors who participated in this pilot study.

Corresponding author: John S. Murray, PhD, MPH, MSGH, RN, FAAN, 20 Chapel St., Unit A502, Brookline, MA 02446; [email protected]

Disclosures: None reported.

From the U.S. Department of Veterans Affairs (all authors), and Cognosante, LLC, Falls Church, VA (Dr. Murray, Dr. Sawyer, and Jessica Fankhauser).

Abstract

Objective: The COVID-19 pandemic posed unprecedented leadership challenges to health care organizations worldwide, especially those on the journey to high reliability. The objective of this pilot quality improvement initiative was to describe the experiences of medical center leaders continuing along the journey to high reliability during the pandemic.

Methods: A convenience sample of Veterans Health Administration medical center directors at facilities that had initiated the journey to high reliability prior to or during the COVID-19 pandemic were asked to complete a confidential survey to explore the challenges experienced and lessons learned.

Results: Of the 35 potential participants, 15 completed the confidential web-based survey. Five major themes emerged from participants’ responses: (1) managing competing priorities, (2) staying committed, (3) adapting and overcoming, (4) prioritizing competing demands, and (5) maintaining momentum.

Conclusion: This pilot quality improvement initiative provides some insight into the challenges experienced and lessons learned during the COVID-19 pandemic to help inform health care leaders’ responses during crises they may encounter along the journey to becoming a high reliability organization.

Keywords: HRO, leadership, patient safety.

Health care leaders worldwide agree that the COVID-19 pandemic has presented one of the most challenging leadership tests encountered in many generations,^1,2 creating a widespread crisis of unprecedented scope and scale for health care systems globally.^2,3 COVID-19 has posed many challenges and obstacles for health care leaders, including overworked, overstressed, and socially isolated employees; expedited hiring to ensure adequate staffing; reallocation of employees to other units; supply shortages such as personal protective equipment; changing polices related to safety protocols; modifying operations; reorganizing facilities to care for large volumes of critically ill patients; and ethical challenges.^4-8 Health care systems were required to create and implement new clinical, operational, and staffing protocols that extended capabilities far beyond conventional standards of care and crisis response operations.⁹ To provide a picture of the impact of COVID-19 on the Veterans Health Administration (VHA), as of March 3, 2023, the VHA has fully vaccinated more than 4.7 million individuals, including 4.3 million veterans and 320,936 federal employees.^10,11

Maintaining continuous progress toward advancing high reliability organization (HRO) principles and practices can be especially challenging during crises of unprecedented scale such as the pandemic. HROs must be continually focused on achieving safety, quality, and efficiency goals by attending to the 3 pillars of HRO: culture, leadership, and continuous process improvement. HROs promote a culture where all staff across the organization watch for and report any unsafe conditions before these conditions pose a greater risk in the workplace. Hospital leaders, from executives to frontline managers, must be cognizant of all systems and processes that have the potential to affect patient care.¹² All of the principles of HROs must continue without fail to ensure patient safety; these principles include preoccupation with failure, anticipating unexpected risks, sensitivity to dynamic and ever-changing operations, avoiding oversimplifications of identified problems, fostering resilience across the organization, and deferring to those with the expertise to make the best decisions regardless of position, rank, or title.^12,13 Given the demands faced by leaders during crises with unprecedented disruption to normal operating procedures, it can be especially difficult to identify systemic challenges and apply lessons learned in a timely manner. However, it is critical to identify such lessons in order to continuously improve and to increase preparedness for subsequent crises.^13,14

Because of the COVID-19 pandemic’s unprecedented nature in recent history, a review of the literature produced little evidence exploring the challenges experienced and lessons learned by health care leaders, especially as it relates to implementing or sustaining HRO journeys during the COVID-19 pandemic. Related literature published to date consists of editorials on reliability, uncertainty, and the management of errors¹⁵; patient safety and high reliability preventive strategies¹⁶; and authentic leadership.¹⁷ Five viewpoints were published on HROs and maladaptive stress behaviors,¹⁸ mindful organizing and organizational reliability,¹⁹ the practical essence of HROs,²⁰ embracing principles of HROs in crisis,⁸ and using observation and high reliability strategies when facing an unprecedented safety threat.²¹ Finally, the authors identified 2 studies that used a qualitative research approach to explore leadership functions within an HRO when managing crises²² and organizational change in response to the COVID-19 pandemic.²³ Due to the paucity of available information, the authors undertook a pilot quality improvement (QI) initiative to address this knowledge gap.

The aim of this initiative was to gain a better understanding of the challenges experienced, lessons learned, and recommendations to be shared by VHA medical center directors (MCDs) of health care facilities that had initiated the journey to high reliability before or during the COVID-19 pandemic. The authors hope that this information will help health care leaders across both governmental and nongovernmental organizations, nationally and globally, to prepare for future pandemics, other unanticipated crises (eg, natural disasters, terrorist attacks), and major change initiatives (eg, electronic health record modernization) that may affect the delivery of safe, high-quality, and effective patient care. The initiative is described using the SQUIRE 2.0 guidelines.^24,25

Methods

Survey

We used a qualitative approach and administered a confidential web-based survey, developed by the project team, to VHA MCDs at facilities that had initiated the journey to high reliability before or during the COVID-19 pandemic. The survey consisted of 8 participant characteristic questions (Table 1) and 4 open-ended questions. The open-ended questions were designed to encourage MCD participants to freely provide detailed descriptions of the challenges experienced, lessons learned, recommendations for other health care leaders, and any additional information they believed was relevant.^26,27 Participants were asked to respond to the following items:

1. Please describe any challenges you experienced while in the role of MCD at a facility that initiated implementation of HRO principles and practices prior to (February 2020) or during (March 2020–September 2021) the initial onset of the COVID-19 pandemic.

1. What are some lessons that you learned when responding to the COVID-19 pandemic while on the journey to high reliability?
2. What recommendations would you like to make to other health care leaders to enable them to respond effectively to crises while on the journey to high reliability?
3. Please provide any additional information that would be of value.

An invitation to participate in this pilot QI initiative was sent via e-mail to 35 potential participants, who were all MCDs at Cohort 1 and Cohort 2 facilities. The invitation was sent on June 17, 2022, by a VHA senior High Reliability Enterprise Support government team member not directly involved with the initiative. The participants were given 3 weeks to complete the survey. A reminder was sent at the end of week 1 and the beginning of week 3. The VHA MCDs from Cohort 1 (n = 17) began the HRO journey in February 2019 and those in Cohort 2 (n = 18) initiated the HRO journey in October 2020. Because the VHA is the largest integrated health care system in the United States, the potential participants were geographically dispersed. Examples of locations in Cohort 1 include Manchester Veterans Affairs Medical Center (VAMC) in New Hampshire, Ralph H. Johnson VAMC in Charleston, South Carolina, and Boise VAMC, in Idaho. Examples of Cohort 2 locations include Chillicothe VAMC in Ohio, Marion VAMC in Indiana, and John D. Dingell VAMC in Detroit, Michigan.

The invitation included the objective of the initiative, estimated time to complete the confidential web-based survey, time allotted for responses to be submitted, and a link to the survey should potential participants agree to participate. Potential participants were informed that their involvement was voluntary, based on their willingness to participate and available time to complete the survey. Finally, the invitation noted that any comments provided would remain confidential and nonattributional for the purpose of publishing and presenting. The inclusion criteria for participation were: (1) serving in the role of MCD of an organization that initiated implementation of HRO principles and practices prior to (February 2020) or during (March 2020–September 2021) the initial onset of the COVID-19 pandemic; (2) voluntary participation; and (3) thorough responses provided to the 4 open-ended and 8 participant characteristic questions, according to the instructions provided.

Data Gathering and Analysis

To minimize bias and maintain neutrality at the organizational level, only non-VHA individuals working on the project were directly involved with participants’ data review and analysis. Participant characteristics were analyzed using descriptive statistics. Responses to the 4 open-ended questions were coded and analyzed by an experienced researcher and coauthor using NVivo 11 qualitative data analysis software.²⁸ To ensure trustworthiness (credibility, transferability, dependability, and confirmability) in the data analysis procedure,²⁹ inductive thematic analysis was also performed manually using the methodologies of Braun and Clarke (Table 2)³⁰ and Erlingsson and Brysiewicz.³¹ The goal of inductive analysis is to allow themes to emerge from the data while minimizing preconceptions.^32,33 Regular team meetings were held to discuss and review the progress of data collection and analysis. The authors agreed that the themes were representative of the participants’ responses.

Institutional review board (IRB) review and approval were not required, as this project was a pilot QI initiative. The intent of the initiative was to explore ways to improve the quality of care delivered in the participants’ local care settings and not to generalize the findings. Under these circumstances, formal IRB review and approval of a QI initiative are not required.³⁴ Participation in this pilot QI initiative was voluntary, and participants could withdraw at any time without consequences. Completion of the survey indicated consent. Confidentiality was ensured at all times by avoiding both the use of facility names and the collection of participant identifiers. Unique numbers were assigned to each participant. All comments provided by survey participants remained confidential and nonattributional for the purpose of publishing and presenting.

Results

Of the 35 potential participants, 15 VHA MCDs (43%) completed the confidential web-based survey. Out of the 17 potential participants in Cohort 1, 6 (35%) completed the survey. With Cohort 2, 9 (50%) of the potential 18 participants responded. Although saturation was reached at 10 responses, the additional completed surveys were included in the analysis. Saturation can be achieved with a small number of participants (n = 9–17), particularly when the potential participants are relatively homogenous and project aims are narrowly defined.³⁵ Most participants had more than 10 years of executive-level experience and most medical centers had been on the journey to high reliability for more than 12 months at the time of the pandemic (Table 3). Five major themes emerged from the participants’ responses: (1) managing competing priorities, (2) staying committed, (3) adapting and overcoming, (4) prioritizing competing demands, and (5) maintaining momentum. In the following sections, the numbers in parentheses after the direct quotes represent the unique numbers assigned to the participant providing the response.

Managing Competing Priorities

When analyzing the responses to question 1, a recurring theme from 7 participants (Cohort 1, n = 4; Cohort 2, n = 3) related to challenges encountered while continuing the journey to high reliability during COVID-19 was managing competing priorities. Although most participants reported extensive previous leadership experience, some did not feel prepared for the complexity, uncertainty, challenges, and multitude of competing priorities facing the journey to high reliability during the COVID-19 pandemic. One participant succinctly noted:

“There were too many competing priorities dealing with the pandemic and staffing crisis.” (Participant 8)

Other participants shared:

“We had our HRO mentor designated just as our first peak was descending on us. It was initially challenging to determine the proper pace of implementation when we clearly had other things going on. There was a real risk that people would say, ‘What, are you kidding?’ as we tried to roll this out.” (Participant 4)

“Prior to COVID, our main challenges were getting organized and operational rollout. During the pandemic, we had to shift our focus to COVID and the training aspects suffered. Also, many other priorities pulled us away from an HRO rollout focus.” (Participant 6)

Staying Committed

When examining the question 2 responses, 1 theme that resonated most when it came to lessons learned, shared by 6 participants (Cohort 1, n = 4; Cohort 2, n = 2), was the need to stay committed to HRO, despite the unprecedented crisis at hand. A number of participants eloquently noted how important it was stay committed to the HRO journey during the COVID-19 pandemic:

“If you don’t need a highly reliable organization during a crisis, when do you need it? That was the message that we kicked off with. It was also VERY important to take things slowly. Education had to be done in bits, and we had a much more modest timeline than what would have been the norm for any initiative pre-COVID. The emphasis was on this being a long-term commitment, that we would be doing it the right way rather than rushing it, etc.” (Participant 4)

“Keeping HRO principles and a Just Culture on the forefront of our minds, we looked for opportunities to progress on our HRO journey, despite the challenges of the pandemic. Our monthly Town Halls became weekly events to share COVID updates and information with staff. We used the Town Halls to promote our HRO mission and to open communication lines with staff, designating 1 week each month as a ‘Safety Forum.’ The pandemic provided the springboard and backdrop for staff Safety Stories submissions, many of which were shared at our Town Halls and Safety Forums.” (Participant 7)

“We were able to utilize HRO principles in response to the COVID pandemic. Specifically standardized communication from the facility to VISN [Veterans Integrated Services Network] was initiated on a daily basis. This practice provided daily communication on key operational items and clinical items at the medical center, allowed timely feedback on actions being taken, as was instrumental in daily checks on staffing, COVID testing supplies, overall supply chain issues.” (Participant 9)

Adapting and Overcoming

The recommendations provided by 10 participants (Cohort 1, n = 6; Cohort 2, n = 4) for other health care leaders experiencing a crisis during the journey to high reliability were insightful. The themes that frequently emerged from the responses to the survey were to adapt and overcome. Participants shared:

“Utilize the many tools you’re given, specifically your team. Try even the craziest ideas from frontline staff.” (Participant 1)

“Use your mentors for younger directors and, even if you think you know the answer, involve your staff. It makes them feel they have a voice and gives them ownership of the issues.” (Participant 5)

“Make sure that you have key leaders in place who are committed to HRO and can help the organization adjust.” (Participant 6)

“Take advantage of HRO Leader Coaching, which pairs MCDs with coaches who act as consultants for HRO leadership practices to ensure progress in reaching the next level in the journey to High Reliability.” (Participant 7)

“Meet regularly with the HRO Lead and team (more frequently during early stages of implementation) to provide support, eliminate barriers, and champion the HRO mission. It is important to include other members of the ELT [Executive Leadership Team] to ensure their involvement with the facility HRO strategic plan.” (Participant 7)

“Prioritize and understand that not everything is priority #1. Continue what you can with HRO, incorporate high reliability principles into the work being done during a crisis, but understand you may need to modify rollout schedules.” (Participant 8)

Prioritizing Competing Demands

The theme of prioritizing competing demands emerged again from 5 participants (Cohort 1, n = 3; Cohort 2, n = 2) with question 3 describing recommendations for other leaders:

“Your first priority is to the crisis. Don’t get distracted by this or any other initiative. That was not a very popular message for the people pushing HRO, but it is the reality and the necessity. However, it IS possible to move forward with HRO (or other important initiatives) during crisis times, as long as you carefully consider what you are asking of people and don’t overload/overwhelm them. It is not your ego (or that of Central Office) that needs to be stoked. If the initiative truly has value, you need to be patient to see it done properly, rather than rushed/pushed/forced. Don’t kill it by being overeager and overwhelming your already overtaxed people. That said, keep moving forward. The key is pacing—and remember that your Type A hard-driving leader types (you know who you are) will certainly fail if they push it. Or even if they go at a normal pace that would be appropriate for noncrisis times.” (Participant 4)

“Prioritize and understand that not everything is priority #1. Continue what you can with HRO, incorporate high reliability principles into the work being done during a crisis, but understand you may need to modify rollout schedules.” (Participant 8)

“It was critical for us to always focus on the immediate workplace safety of staff (especially those on the frontlines of the pandemic response) when in the process of rolling out HRO initiatives.” (Participant 14)

Maintaining Momentum

When analyzing additional information that participants thought would be of value, 3 participants (Cohort 1, n=2; Cohort 2, n=1) noted the importance of maintaining momentum with HRO during a crisis:

“It seemed as though communication and education from VHA on HRO slowed down at the same time, which further slowed our progress. We are now trying to ramp our engagement up again.” (Participant 3)

“There can be synergy between crisis response and HRO implementation. As an example, one of the first steps we took was leadership rounding. That was necessary anyways for crisis management (raising the spirits on the front lines, so to speak). What we did was include scheduled time instead of (in addition to) ad hoc. And we got credit for taking an HRO step. I resisted whiteboards/visual management systems for a long time because (in my opinion) that would have been much too distracting during the crisis. Having waited for better times, I was able to move forward with that several months later and with good success.” (Participant 4)

Discussion

Health care leaders worldwide experienced an immense set of challenges because of the COVID-19 pandemic, which is a crisis of a magnitude with no parallel in modern times. Strong, adaptive leadership at all levels of health care systems was needed to effectively address the immense crisis at hand.^36,37 Findings from this pilot QI initiative suggest that MCDs faced many new challenges, requiring them to perform unfamiliar tasks and manage numerous overlapping challenges (eg, staffing shortages and reassignments, safety concerns, changes to patient appointments, backlogs in essential services), all while also trying to continue with the journey to high reliability. Despite the challenges leaders faced, they recognized the need to manage competing priorities early and effectively. At times, the priority was to address the wide-ranging, urgent issues related to the pandemic. When the conditions improved, there was time to refocus efforts on important but longer-term activities related to the HRO journey. Other participants recognized that their commitment to HRO needed to remain a priority even during the periods of intense focus on COVID-19. These participants continuously looked for ways to integrate HRO principles and practices into their response to the extraordinary challenges of the pandemic. Emerging research highlights how leaders had to modify their day-to-day responsibilities because of the wide disruptions caused by the COVID-19 pandemic, even when not on the journey to becoming an HRO.^36,37

Some participants felt compelled to stay committed to the HRO journey despite numerous competing demands. They stayed committed to looking for opportunities to progress by implementing HRO principles and practices to achieve safety, quality, and efficiency goals. This dedication is noteworthy, especially in light of recently published research that demonstrates the vast number of patient safety issues that presented during the COVID-19 pandemic (eg, ineffective communication, poor teamwork, the absence of coordination)¹ as well as perceptions that patient safety and quality of care had significantly declined as a result of the crisis.^36,37

Participants also highlighted the need to be adaptive when responding to the complexity and unpredictability of the pandemic. Participants regularly sought ways to increase their knowledge, skills, and abilities by using the resources (eg, tools, experts) available to them. Research shows that in increasingly complex and ever-changing situation such as the COVID-19 pandemic, leaders must be adaptive with all levels of performance, especially when limited information is available.^38,39

This is the first initiative of its kind to specifically explore the challenges experienced and lessons learned from health care leaders continuing along the journey to high reliability during the COVID-19 pandemic. Findings from this pilot QI initiative revealed that many participants recommended that leaders adapt and overcome challenges as much as possible when continuing with HRO during a crisis. These findings are echoed in the current literature suggesting that adaptive performance is a highly effective form of leadership during crises.^38,40 Being able to effectively adapt during a crisis is essential for reducing further vulnerabilities across health care systems. In fact, this lesson is shared by many countries in response to the unprecedented global crisis.⁴¹A limitation of this pilot QI initiative is that the authors did not directly solicit responses from all VHA MCDs or from other health care executives (eg, Chief of Staff, Associate Director for Operations, Associate Director for Patient Care, and Nurse Executive). As such, our findings represent only a small segment of senior leadership perspectives from a large, integrated health care system. Individuals who did not respond to the survey may have had different experiences than those who did, and the authors excluded many MCDs who formally began their HRO journeys in 2022, well after the pandemic was underway. Similarly, the experiences of Veterans Affairs leaders may or may not be similar to that of other health care organizations. Although the goal of this initiative was to explore the participants’ experiences during the period of crisis, time and distance from the events at the height of the COVID-19 pandemic may have resulted in difficulty recalling information as well as making sense of the occurrence. This potential recall bias is a common occurrence in trying to explore past experiences, especially as they relate to crises. Finally, this pilot QI initiative did not explore personal challenges participants may have faced during this period of time (eg, burnout, personal or family illness), which may have also shaped their responses.

Conclusion

This initiative suggests that VHA MCDs often relied on HRO principles to guide and assist with their response to the COVID-19 pandemic, including managing periods of unprecedented crisis. The ability to adapt and prioritize was seen as an especially important lesson. Many MCDs continued their personal and organizational efforts toward high reliability even in periods of intense challenge because of the pandemic. These findings can help with future crises that may occur during an organization’s journey to high reliability. This pilot QI initiative’s findings warrant further investigation to explore the experiences of the broader range of health care leaders while responding to unplanned crises or even planned large-scale cultural change or technology modernization initiatives (eg, electronic health record modernization) to expand the state of the science of high reliability as well as inform policy and decision-making. Finally, another area for future study is examining how leadership responses vary across facilities, depending on factors such as leader roles, facility complexity level, resource availability, patient population characteristics, and organizational culture.

Acknowledgment: The authors express their sincere gratitude to the medical center directors who participated in this pilot study.

Corresponding author: John S. Murray, PhD, MPH, MSGH, RN, FAAN, 20 Chapel St., Unit A502, Brookline, MA 02446; [email protected]

Disclosures: None reported.

From the U.S. Department of Veterans Affairs (all authors), and Cognosante, LLC, Falls Church, VA (Dr. Murray, Dr. Sawyer, and Jessica Fankhauser).

Abstract

Objective: The COVID-19 pandemic posed unprecedented leadership challenges to health care organizations worldwide, especially those on the journey to high reliability. The objective of this pilot quality improvement initiative was to describe the experiences of medical center leaders continuing along the journey to high reliability during the pandemic.

Methods: A convenience sample of Veterans Health Administration medical center directors at facilities that had initiated the journey to high reliability prior to or during the COVID-19 pandemic were asked to complete a confidential survey to explore the challenges experienced and lessons learned.

Results: Of the 35 potential participants, 15 completed the confidential web-based survey. Five major themes emerged from participants’ responses: (1) managing competing priorities, (2) staying committed, (3) adapting and overcoming, (4) prioritizing competing demands, and (5) maintaining momentum.

Conclusion: This pilot quality improvement initiative provides some insight into the challenges experienced and lessons learned during the COVID-19 pandemic to help inform health care leaders’ responses during crises they may encounter along the journey to becoming a high reliability organization.

Keywords: HRO, leadership, patient safety.

Health care leaders worldwide agree that the COVID-19 pandemic has presented one of the most challenging leadership tests encountered in many generations,^1,2 creating a widespread crisis of unprecedented scope and scale for health care systems globally.^2,3 COVID-19 has posed many challenges and obstacles for health care leaders, including overworked, overstressed, and socially isolated employees; expedited hiring to ensure adequate staffing; reallocation of employees to other units; supply shortages such as personal protective equipment; changing polices related to safety protocols; modifying operations; reorganizing facilities to care for large volumes of critically ill patients; and ethical challenges.^4-8 Health care systems were required to create and implement new clinical, operational, and staffing protocols that extended capabilities far beyond conventional standards of care and crisis response operations.⁹ To provide a picture of the impact of COVID-19 on the Veterans Health Administration (VHA), as of March 3, 2023, the VHA has fully vaccinated more than 4.7 million individuals, including 4.3 million veterans and 320,936 federal employees.^10,11

Maintaining continuous progress toward advancing high reliability organization (HRO) principles and practices can be especially challenging during crises of unprecedented scale such as the pandemic. HROs must be continually focused on achieving safety, quality, and efficiency goals by attending to the 3 pillars of HRO: culture, leadership, and continuous process improvement. HROs promote a culture where all staff across the organization watch for and report any unsafe conditions before these conditions pose a greater risk in the workplace. Hospital leaders, from executives to frontline managers, must be cognizant of all systems and processes that have the potential to affect patient care.¹² All of the principles of HROs must continue without fail to ensure patient safety; these principles include preoccupation with failure, anticipating unexpected risks, sensitivity to dynamic and ever-changing operations, avoiding oversimplifications of identified problems, fostering resilience across the organization, and deferring to those with the expertise to make the best decisions regardless of position, rank, or title.^12,13 Given the demands faced by leaders during crises with unprecedented disruption to normal operating procedures, it can be especially difficult to identify systemic challenges and apply lessons learned in a timely manner. However, it is critical to identify such lessons in order to continuously improve and to increase preparedness for subsequent crises.^13,14

Because of the COVID-19 pandemic’s unprecedented nature in recent history, a review of the literature produced little evidence exploring the challenges experienced and lessons learned by health care leaders, especially as it relates to implementing or sustaining HRO journeys during the COVID-19 pandemic. Related literature published to date consists of editorials on reliability, uncertainty, and the management of errors¹⁵; patient safety and high reliability preventive strategies¹⁶; and authentic leadership.¹⁷ Five viewpoints were published on HROs and maladaptive stress behaviors,¹⁸ mindful organizing and organizational reliability,¹⁹ the practical essence of HROs,²⁰ embracing principles of HROs in crisis,⁸ and using observation and high reliability strategies when facing an unprecedented safety threat.²¹ Finally, the authors identified 2 studies that used a qualitative research approach to explore leadership functions within an HRO when managing crises²² and organizational change in response to the COVID-19 pandemic.²³ Due to the paucity of available information, the authors undertook a pilot quality improvement (QI) initiative to address this knowledge gap.

The aim of this initiative was to gain a better understanding of the challenges experienced, lessons learned, and recommendations to be shared by VHA medical center directors (MCDs) of health care facilities that had initiated the journey to high reliability before or during the COVID-19 pandemic. The authors hope that this information will help health care leaders across both governmental and nongovernmental organizations, nationally and globally, to prepare for future pandemics, other unanticipated crises (eg, natural disasters, terrorist attacks), and major change initiatives (eg, electronic health record modernization) that may affect the delivery of safe, high-quality, and effective patient care. The initiative is described using the SQUIRE 2.0 guidelines.^24,25

Methods

Survey

We used a qualitative approach and administered a confidential web-based survey, developed by the project team, to VHA MCDs at facilities that had initiated the journey to high reliability before or during the COVID-19 pandemic. The survey consisted of 8 participant characteristic questions (Table 1) and 4 open-ended questions. The open-ended questions were designed to encourage MCD participants to freely provide detailed descriptions of the challenges experienced, lessons learned, recommendations for other health care leaders, and any additional information they believed was relevant.^26,27 Participants were asked to respond to the following items:

1. Please describe any challenges you experienced while in the role of MCD at a facility that initiated implementation of HRO principles and practices prior to (February 2020) or during (March 2020–September 2021) the initial onset of the COVID-19 pandemic.

1. What are some lessons that you learned when responding to the COVID-19 pandemic while on the journey to high reliability?
2. What recommendations would you like to make to other health care leaders to enable them to respond effectively to crises while on the journey to high reliability?
3. Please provide any additional information that would be of value.

An invitation to participate in this pilot QI initiative was sent via e-mail to 35 potential participants, who were all MCDs at Cohort 1 and Cohort 2 facilities. The invitation was sent on June 17, 2022, by a VHA senior High Reliability Enterprise Support government team member not directly involved with the initiative. The participants were given 3 weeks to complete the survey. A reminder was sent at the end of week 1 and the beginning of week 3. The VHA MCDs from Cohort 1 (n = 17) began the HRO journey in February 2019 and those in Cohort 2 (n = 18) initiated the HRO journey in October 2020. Because the VHA is the largest integrated health care system in the United States, the potential participants were geographically dispersed. Examples of locations in Cohort 1 include Manchester Veterans Affairs Medical Center (VAMC) in New Hampshire, Ralph H. Johnson VAMC in Charleston, South Carolina, and Boise VAMC, in Idaho. Examples of Cohort 2 locations include Chillicothe VAMC in Ohio, Marion VAMC in Indiana, and John D. Dingell VAMC in Detroit, Michigan.

The invitation included the objective of the initiative, estimated time to complete the confidential web-based survey, time allotted for responses to be submitted, and a link to the survey should potential participants agree to participate. Potential participants were informed that their involvement was voluntary, based on their willingness to participate and available time to complete the survey. Finally, the invitation noted that any comments provided would remain confidential and nonattributional for the purpose of publishing and presenting. The inclusion criteria for participation were: (1) serving in the role of MCD of an organization that initiated implementation of HRO principles and practices prior to (February 2020) or during (March 2020–September 2021) the initial onset of the COVID-19 pandemic; (2) voluntary participation; and (3) thorough responses provided to the 4 open-ended and 8 participant characteristic questions, according to the instructions provided.

Data Gathering and Analysis

To minimize bias and maintain neutrality at the organizational level, only non-VHA individuals working on the project were directly involved with participants’ data review and analysis. Participant characteristics were analyzed using descriptive statistics. Responses to the 4 open-ended questions were coded and analyzed by an experienced researcher and coauthor using NVivo 11 qualitative data analysis software.²⁸ To ensure trustworthiness (credibility, transferability, dependability, and confirmability) in the data analysis procedure,²⁹ inductive thematic analysis was also performed manually using the methodologies of Braun and Clarke (Table 2)³⁰ and Erlingsson and Brysiewicz.³¹ The goal of inductive analysis is to allow themes to emerge from the data while minimizing preconceptions.^32,33 Regular team meetings were held to discuss and review the progress of data collection and analysis. The authors agreed that the themes were representative of the participants’ responses.

Institutional review board (IRB) review and approval were not required, as this project was a pilot QI initiative. The intent of the initiative was to explore ways to improve the quality of care delivered in the participants’ local care settings and not to generalize the findings. Under these circumstances, formal IRB review and approval of a QI initiative are not required.³⁴ Participation in this pilot QI initiative was voluntary, and participants could withdraw at any time without consequences. Completion of the survey indicated consent. Confidentiality was ensured at all times by avoiding both the use of facility names and the collection of participant identifiers. Unique numbers were assigned to each participant. All comments provided by survey participants remained confidential and nonattributional for the purpose of publishing and presenting.

Results

Of the 35 potential participants, 15 VHA MCDs (43%) completed the confidential web-based survey. Out of the 17 potential participants in Cohort 1, 6 (35%) completed the survey. With Cohort 2, 9 (50%) of the potential 18 participants responded. Although saturation was reached at 10 responses, the additional completed surveys were included in the analysis. Saturation can be achieved with a small number of participants (n = 9–17), particularly when the potential participants are relatively homogenous and project aims are narrowly defined.³⁵ Most participants had more than 10 years of executive-level experience and most medical centers had been on the journey to high reliability for more than 12 months at the time of the pandemic (Table 3). Five major themes emerged from the participants’ responses: (1) managing competing priorities, (2) staying committed, (3) adapting and overcoming, (4) prioritizing competing demands, and (5) maintaining momentum. In the following sections, the numbers in parentheses after the direct quotes represent the unique numbers assigned to the participant providing the response.

Managing Competing Priorities

When analyzing the responses to question 1, a recurring theme from 7 participants (Cohort 1, n = 4; Cohort 2, n = 3) related to challenges encountered while continuing the journey to high reliability during COVID-19 was managing competing priorities. Although most participants reported extensive previous leadership experience, some did not feel prepared for the complexity, uncertainty, challenges, and multitude of competing priorities facing the journey to high reliability during the COVID-19 pandemic. One participant succinctly noted:

“There were too many competing priorities dealing with the pandemic and staffing crisis.” (Participant 8)

Other participants shared:

“We had our HRO mentor designated just as our first peak was descending on us. It was initially challenging to determine the proper pace of implementation when we clearly had other things going on. There was a real risk that people would say, ‘What, are you kidding?’ as we tried to roll this out.” (Participant 4)

“Prior to COVID, our main challenges were getting organized and operational rollout. During the pandemic, we had to shift our focus to COVID and the training aspects suffered. Also, many other priorities pulled us away from an HRO rollout focus.” (Participant 6)

Staying Committed

When examining the question 2 responses, 1 theme that resonated most when it came to lessons learned, shared by 6 participants (Cohort 1, n = 4; Cohort 2, n = 2), was the need to stay committed to HRO, despite the unprecedented crisis at hand. A number of participants eloquently noted how important it was stay committed to the HRO journey during the COVID-19 pandemic:

“If you don’t need a highly reliable organization during a crisis, when do you need it? That was the message that we kicked off with. It was also VERY important to take things slowly. Education had to be done in bits, and we had a much more modest timeline than what would have been the norm for any initiative pre-COVID. The emphasis was on this being a long-term commitment, that we would be doing it the right way rather than rushing it, etc.” (Participant 4)

“Keeping HRO principles and a Just Culture on the forefront of our minds, we looked for opportunities to progress on our HRO journey, despite the challenges of the pandemic. Our monthly Town Halls became weekly events to share COVID updates and information with staff. We used the Town Halls to promote our HRO mission and to open communication lines with staff, designating 1 week each month as a ‘Safety Forum.’ The pandemic provided the springboard and backdrop for staff Safety Stories submissions, many of which were shared at our Town Halls and Safety Forums.” (Participant 7)

“We were able to utilize HRO principles in response to the COVID pandemic. Specifically standardized communication from the facility to VISN [Veterans Integrated Services Network] was initiated on a daily basis. This practice provided daily communication on key operational items and clinical items at the medical center, allowed timely feedback on actions being taken, as was instrumental in daily checks on staffing, COVID testing supplies, overall supply chain issues.” (Participant 9)

Adapting and Overcoming

The recommendations provided by 10 participants (Cohort 1, n = 6; Cohort 2, n = 4) for other health care leaders experiencing a crisis during the journey to high reliability were insightful. The themes that frequently emerged from the responses to the survey were to adapt and overcome. Participants shared:

“Utilize the many tools you’re given, specifically your team. Try even the craziest ideas from frontline staff.” (Participant 1)

“Use your mentors for younger directors and, even if you think you know the answer, involve your staff. It makes them feel they have a voice and gives them ownership of the issues.” (Participant 5)

“Make sure that you have key leaders in place who are committed to HRO and can help the organization adjust.” (Participant 6)

“Take advantage of HRO Leader Coaching, which pairs MCDs with coaches who act as consultants for HRO leadership practices to ensure progress in reaching the next level in the journey to High Reliability.” (Participant 7)

“Meet regularly with the HRO Lead and team (more frequently during early stages of implementation) to provide support, eliminate barriers, and champion the HRO mission. It is important to include other members of the ELT [Executive Leadership Team] to ensure their involvement with the facility HRO strategic plan.” (Participant 7)

“Prioritize and understand that not everything is priority #1. Continue what you can with HRO, incorporate high reliability principles into the work being done during a crisis, but understand you may need to modify rollout schedules.” (Participant 8)

Prioritizing Competing Demands

The theme of prioritizing competing demands emerged again from 5 participants (Cohort 1, n = 3; Cohort 2, n = 2) with question 3 describing recommendations for other leaders:

“Your first priority is to the crisis. Don’t get distracted by this or any other initiative. That was not a very popular message for the people pushing HRO, but it is the reality and the necessity. However, it IS possible to move forward with HRO (or other important initiatives) during crisis times, as long as you carefully consider what you are asking of people and don’t overload/overwhelm them. It is not your ego (or that of Central Office) that needs to be stoked. If the initiative truly has value, you need to be patient to see it done properly, rather than rushed/pushed/forced. Don’t kill it by being overeager and overwhelming your already overtaxed people. That said, keep moving forward. The key is pacing—and remember that your Type A hard-driving leader types (you know who you are) will certainly fail if they push it. Or even if they go at a normal pace that would be appropriate for noncrisis times.” (Participant 4)

“Prioritize and understand that not everything is priority #1. Continue what you can with HRO, incorporate high reliability principles into the work being done during a crisis, but understand you may need to modify rollout schedules.” (Participant 8)

“It was critical for us to always focus on the immediate workplace safety of staff (especially those on the frontlines of the pandemic response) when in the process of rolling out HRO initiatives.” (Participant 14)

Maintaining Momentum

When analyzing additional information that participants thought would be of value, 3 participants (Cohort 1, n=2; Cohort 2, n=1) noted the importance of maintaining momentum with HRO during a crisis:

“It seemed as though communication and education from VHA on HRO slowed down at the same time, which further slowed our progress. We are now trying to ramp our engagement up again.” (Participant 3)

“There can be synergy between crisis response and HRO implementation. As an example, one of the first steps we took was leadership rounding. That was necessary anyways for crisis management (raising the spirits on the front lines, so to speak). What we did was include scheduled time instead of (in addition to) ad hoc. And we got credit for taking an HRO step. I resisted whiteboards/visual management systems for a long time because (in my opinion) that would have been much too distracting during the crisis. Having waited for better times, I was able to move forward with that several months later and with good success.” (Participant 4)

Discussion

Health care leaders worldwide experienced an immense set of challenges because of the COVID-19 pandemic, which is a crisis of a magnitude with no parallel in modern times. Strong, adaptive leadership at all levels of health care systems was needed to effectively address the immense crisis at hand.^36,37 Findings from this pilot QI initiative suggest that MCDs faced many new challenges, requiring them to perform unfamiliar tasks and manage numerous overlapping challenges (eg, staffing shortages and reassignments, safety concerns, changes to patient appointments, backlogs in essential services), all while also trying to continue with the journey to high reliability. Despite the challenges leaders faced, they recognized the need to manage competing priorities early and effectively. At times, the priority was to address the wide-ranging, urgent issues related to the pandemic. When the conditions improved, there was time to refocus efforts on important but longer-term activities related to the HRO journey. Other participants recognized that their commitment to HRO needed to remain a priority even during the periods of intense focus on COVID-19. These participants continuously looked for ways to integrate HRO principles and practices into their response to the extraordinary challenges of the pandemic. Emerging research highlights how leaders had to modify their day-to-day responsibilities because of the wide disruptions caused by the COVID-19 pandemic, even when not on the journey to becoming an HRO.^36,37

Some participants felt compelled to stay committed to the HRO journey despite numerous competing demands. They stayed committed to looking for opportunities to progress by implementing HRO principles and practices to achieve safety, quality, and efficiency goals. This dedication is noteworthy, especially in light of recently published research that demonstrates the vast number of patient safety issues that presented during the COVID-19 pandemic (eg, ineffective communication, poor teamwork, the absence of coordination)¹ as well as perceptions that patient safety and quality of care had significantly declined as a result of the crisis.^36,37

Participants also highlighted the need to be adaptive when responding to the complexity and unpredictability of the pandemic. Participants regularly sought ways to increase their knowledge, skills, and abilities by using the resources (eg, tools, experts) available to them. Research shows that in increasingly complex and ever-changing situation such as the COVID-19 pandemic, leaders must be adaptive with all levels of performance, especially when limited information is available.^38,39

This is the first initiative of its kind to specifically explore the challenges experienced and lessons learned from health care leaders continuing along the journey to high reliability during the COVID-19 pandemic. Findings from this pilot QI initiative revealed that many participants recommended that leaders adapt and overcome challenges as much as possible when continuing with HRO during a crisis. These findings are echoed in the current literature suggesting that adaptive performance is a highly effective form of leadership during crises.^38,40 Being able to effectively adapt during a crisis is essential for reducing further vulnerabilities across health care systems. In fact, this lesson is shared by many countries in response to the unprecedented global crisis.⁴¹A limitation of this pilot QI initiative is that the authors did not directly solicit responses from all VHA MCDs or from other health care executives (eg, Chief of Staff, Associate Director for Operations, Associate Director for Patient Care, and Nurse Executive). As such, our findings represent only a small segment of senior leadership perspectives from a large, integrated health care system. Individuals who did not respond to the survey may have had different experiences than those who did, and the authors excluded many MCDs who formally began their HRO journeys in 2022, well after the pandemic was underway. Similarly, the experiences of Veterans Affairs leaders may or may not be similar to that of other health care organizations. Although the goal of this initiative was to explore the participants’ experiences during the period of crisis, time and distance from the events at the height of the COVID-19 pandemic may have resulted in difficulty recalling information as well as making sense of the occurrence. This potential recall bias is a common occurrence in trying to explore past experiences, especially as they relate to crises. Finally, this pilot QI initiative did not explore personal challenges participants may have faced during this period of time (eg, burnout, personal or family illness), which may have also shaped their responses.

Conclusion

This initiative suggests that VHA MCDs often relied on HRO principles to guide and assist with their response to the COVID-19 pandemic, including managing periods of unprecedented crisis. The ability to adapt and prioritize was seen as an especially important lesson. Many MCDs continued their personal and organizational efforts toward high reliability even in periods of intense challenge because of the pandemic. These findings can help with future crises that may occur during an organization’s journey to high reliability. This pilot QI initiative’s findings warrant further investigation to explore the experiences of the broader range of health care leaders while responding to unplanned crises or even planned large-scale cultural change or technology modernization initiatives (eg, electronic health record modernization) to expand the state of the science of high reliability as well as inform policy and decision-making. Finally, another area for future study is examining how leadership responses vary across facilities, depending on factors such as leader roles, facility complexity level, resource availability, patient population characteristics, and organizational culture.

Acknowledgment: The authors express their sincere gratitude to the medical center directors who participated in this pilot study.

Corresponding author: John S. Murray, PhD, MPH, MSGH, RN, FAAN, 20 Chapel St., Unit A502, Brookline, MA 02446; [email protected]

Disclosures: None reported.

This year marks the publication of the 30th volume of the Journal of Clinical Outcomes Management (JCOM). As we celebrate JCOM’s 30th year, we look forward to the future and continuing the journey to inform quality improvement leaders and practitioners about advances in the field and share experiences. The path forward on this journey involves collaboration across stakeholders, the application of innovative improvement methods, and a commitment to achieving health equity. Health care quality improvement plans must prioritize patient-centered care, promote evidence-based practices and continuous learning, and establish clear metrics to measure progress and success. Furthermore, engagement with patients and communities must be at the forefront of any quality improvement plan, as their perspectives and experiences are essential to understanding and addressing the root causes of disparities in health care delivery. Additionally, effective communication and coordination among health care providers, administrators, policymakers, and other stakeholders are crucial to achieving sustainable improvements in health care quality.

JCOM’s mission is to serve as a platform for sharing knowledge, experiences, and best practices to improve patient outcomes and promote health equity. The vision encompasses a world where all individuals have access to high-quality, patient-centered health care that is free of disparities and achieves optimal health outcomes. JCOM’s strategy is to publish articles that showcase innovative quality improvement initiatives, share evidence-based practices and research findings, highlight successful collaborations, and provide practical guidance for health care professionals to implement quality improvement initiatives in their organizations.

We believe that by sharing these insights and experiences, we can accelerate progress toward achieving equitable and high-quality health care for all individuals and communities, regardless of their socioeconomic status, race/ethnicity, gender identity, or any other factor that may impact their access to care and health outcomes. We continue to welcome submissions from all health care professionals, researchers, and other stakeholders involved in quality improvement initiatives. Together, we can work toward a future where every individual has access to the highest quality of health care and experiences equitable health outcomes.

A comprehensive and collaborative approach to health care quality improvement, which is led by a peer review process and scientific publication of the progress, is a necessary part of ensuring that all patients receive high-quality care that is equitable and patient-centered. The future of health care quality will require further research and scholarly work in the areas of training and development, data infrastructure and analytics, as well as technology-enabled solutions that support continuous improvement and innovation. Health care organizations can build a culture of quality improvement that drives meaningful progress toward achieving health equity and improving health care delivery for all by sharing the output from their research.

Thank you for joining us in this mission to improve health care quality, promote optimal health care delivery methods, and create a world where health care is not only accessible, but also equitable and of the highest standards. Let us continue to work toward building a health care system that prioritizes patient-centered care. Together, we can make a difference and ensure that every individual receives the care they need and deserve.

Corresponding author: Ebrahim Barkoudah, MD, MPH; [email protected]

This year marks the publication of the 30th volume of the Journal of Clinical Outcomes Management (JCOM). As we celebrate JCOM’s 30th year, we look forward to the future and continuing the journey to inform quality improvement leaders and practitioners about advances in the field and share experiences. The path forward on this journey involves collaboration across stakeholders, the application of innovative improvement methods, and a commitment to achieving health equity. Health care quality improvement plans must prioritize patient-centered care, promote evidence-based practices and continuous learning, and establish clear metrics to measure progress and success. Furthermore, engagement with patients and communities must be at the forefront of any quality improvement plan, as their perspectives and experiences are essential to understanding and addressing the root causes of disparities in health care delivery. Additionally, effective communication and coordination among health care providers, administrators, policymakers, and other stakeholders are crucial to achieving sustainable improvements in health care quality.

JCOM’s mission is to serve as a platform for sharing knowledge, experiences, and best practices to improve patient outcomes and promote health equity. The vision encompasses a world where all individuals have access to high-quality, patient-centered health care that is free of disparities and achieves optimal health outcomes. JCOM’s strategy is to publish articles that showcase innovative quality improvement initiatives, share evidence-based practices and research findings, highlight successful collaborations, and provide practical guidance for health care professionals to implement quality improvement initiatives in their organizations.

We believe that by sharing these insights and experiences, we can accelerate progress toward achieving equitable and high-quality health care for all individuals and communities, regardless of their socioeconomic status, race/ethnicity, gender identity, or any other factor that may impact their access to care and health outcomes. We continue to welcome submissions from all health care professionals, researchers, and other stakeholders involved in quality improvement initiatives. Together, we can work toward a future where every individual has access to the highest quality of health care and experiences equitable health outcomes.

A comprehensive and collaborative approach to health care quality improvement, which is led by a peer review process and scientific publication of the progress, is a necessary part of ensuring that all patients receive high-quality care that is equitable and patient-centered. The future of health care quality will require further research and scholarly work in the areas of training and development, data infrastructure and analytics, as well as technology-enabled solutions that support continuous improvement and innovation. Health care organizations can build a culture of quality improvement that drives meaningful progress toward achieving health equity and improving health care delivery for all by sharing the output from their research.

Thank you for joining us in this mission to improve health care quality, promote optimal health care delivery methods, and create a world where health care is not only accessible, but also equitable and of the highest standards. Let us continue to work toward building a health care system that prioritizes patient-centered care. Together, we can make a difference and ensure that every individual receives the care they need and deserve.

Corresponding author: Ebrahim Barkoudah, MD, MPH; [email protected]

This year marks the publication of the 30th volume of the Journal of Clinical Outcomes Management (JCOM). As we celebrate JCOM’s 30th year, we look forward to the future and continuing the journey to inform quality improvement leaders and practitioners about advances in the field and share experiences. The path forward on this journey involves collaboration across stakeholders, the application of innovative improvement methods, and a commitment to achieving health equity. Health care quality improvement plans must prioritize patient-centered care, promote evidence-based practices and continuous learning, and establish clear metrics to measure progress and success. Furthermore, engagement with patients and communities must be at the forefront of any quality improvement plan, as their perspectives and experiences are essential to understanding and addressing the root causes of disparities in health care delivery. Additionally, effective communication and coordination among health care providers, administrators, policymakers, and other stakeholders are crucial to achieving sustainable improvements in health care quality.

JCOM’s mission is to serve as a platform for sharing knowledge, experiences, and best practices to improve patient outcomes and promote health equity. The vision encompasses a world where all individuals have access to high-quality, patient-centered health care that is free of disparities and achieves optimal health outcomes. JCOM’s strategy is to publish articles that showcase innovative quality improvement initiatives, share evidence-based practices and research findings, highlight successful collaborations, and provide practical guidance for health care professionals to implement quality improvement initiatives in their organizations.

We believe that by sharing these insights and experiences, we can accelerate progress toward achieving equitable and high-quality health care for all individuals and communities, regardless of their socioeconomic status, race/ethnicity, gender identity, or any other factor that may impact their access to care and health outcomes. We continue to welcome submissions from all health care professionals, researchers, and other stakeholders involved in quality improvement initiatives. Together, we can work toward a future where every individual has access to the highest quality of health care and experiences equitable health outcomes.

A comprehensive and collaborative approach to health care quality improvement, which is led by a peer review process and scientific publication of the progress, is a necessary part of ensuring that all patients receive high-quality care that is equitable and patient-centered. The future of health care quality will require further research and scholarly work in the areas of training and development, data infrastructure and analytics, as well as technology-enabled solutions that support continuous improvement and innovation. Health care organizations can build a culture of quality improvement that drives meaningful progress toward achieving health equity and improving health care delivery for all by sharing the output from their research.

Thank you for joining us in this mission to improve health care quality, promote optimal health care delivery methods, and create a world where health care is not only accessible, but also equitable and of the highest standards. Let us continue to work toward building a health care system that prioritizes patient-centered care. Together, we can make a difference and ensure that every individual receives the care they need and deserve.

Corresponding author: Ebrahim Barkoudah, MD, MPH; [email protected]

Study 1 Overview (Menon et al)

Objective: To determine whether a 0.25 mg/kg dose of intravenous tenecteplase is noninferior to intravenous alteplase 0.9 mg/kg for patients with acute ischemic stroke eligible for thrombolytic therapy.

Design: Multicenter, parallel-group, open-label randomized controlled trial.

Setting and participants: The trial was conducted at 22 primary and comprehensive stroke centers across Canada. A primary stroke center was defined as a hospital capable of offering intravenous thrombolysis to patients with acute ischemic stroke, while a comprehensive stroke center was able to offer thrombectomy services in addition. The involved centers also participated in Canadian quality improvement registries (either Quality Improvement and Clinical Research [QuiCR] or Optimizing Patient Treatment in Major Ischemic Stroke with EVT [OPTIMISE]) that track patient outcomes. Patients were eligible for inclusion if they were aged 18 years or older, had a diagnosis of acute ischemic stroke, presented within 4.5 hours of symptom onset, and were eligible for thrombolysis according to Canadian guidelines.

Patients were randomized in a 1:1 fashion to either intravenous tenecteplase (0.25 mg/kg single dose, maximum of 25 mg) or intravenous alteplase (0.9 mg/kg total dose to a maximum of 90 mg, delivered as a bolus followed by a continuous infusion). A total of 1600 patients were enrolled, with 816 randomly assigned to the tenecteplase arm and 784 to the alteplase arm; 1577 patients were included in the intention-to-treat (ITT) analysis (n = 806 tenecteplase; n = 771 alteplase). The median age of enrollees was 74 years, and 52.1% of the ITT population were men.

Main outcome measures: In the ITT population, the primary outcome measure was a modified Rankin score (mRS) of 0 or 1 at 90 to 120 days post treatment. Safety outcomes included symptomatic intracerebral hemorrhage, orolingual angioedema, extracranial bleeding that required blood transfusion (all within 24 hours of thrombolytic administration), and all-cause mortality at 90 days. The noninferiority threshold for intravenous tenecteplase was set as the lower 95% CI of the difference between the tenecteplase and alteplase groups in the proportion of patients who met the primary outcome exceeding –5%.

Main results: The primary outcome of mRS of either 0 or 1 at 90 to 120 days of treatment occurred in 296 (36.9%) of the 802 patients assigned to tenecteplase and 266 (34.8%) of the 765 patients assigned to alteplase (unadjusted risk difference, 2.1%; 95% CI, –2.6 to 6.9). The prespecified noninferiority threshold was met. There were no significant differences between the groups in rates of intracerebral hemorrhage at 24 hours or 90-day all-cause mortality.

Conclusion: Intravenous tenecteplase is a reasonable alternative to alteplase for patients eligible for thrombolytic therapy.

Study 2 Overview (Wang et al)

Objective: To determine whether tenecteplase (dose 0.25 mg/kg) is noninferior to alteplase in patients with acute ischemic stroke who are within 4.5 hours of symptom onset and eligible for thrombolytic therapy but either refused or were ineligible for endovascular thrombectomy.

Design: Multicenter, prospective, open-label, randomized, controlled noninferiority trial.

Setting and participants: This trial was conducted at 53 centers across China and included patients 18 years of age or older who were within 4.5 hours of symptom onset and were thrombolytic eligible, had a mRS ≤ 1 at enrollment, and had a National Institutes of Health Stroke Scale score between 5 and 25. Eligible participants were randomized 1:1 to either tenecteplase 0.25 mg/kg (maximum dose 25 mg) or alteplase 0.9 mg/kg (maximum dose 90 mg, administered as a bolus followed by infusion). During the enrollment period (June 12, 2021, to May 29, 2022), a total of 1430 participants were enrolled, and, of those, 716 were randomly assigned to tenecteplase and 714 to alteplase. Six patients assigned to tenecteplase and 7 assigned to alteplase did not receive drugs. At 90 days, 5 in the tenecteplase group and 11 in the alteplase group were lost to follow up.

Main outcome measures: The primary efficacy outcome was a mRS of 0 or 1 at 90 days. The primary safety outcome was intracranial hemorrhage within 36 hours. Safety outcomes included parenchymal hematoma 2, as defined by the European Cooperative Acute Stroke Study III; any intracranial or significant hemorrhage, as defined by the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries criteria; and death from all causes at 90 days. Noninferiority for tenecteplase would be declared if the lower 97.5% 1-sided CI for the relative risk (RR) for the primary outcome did not cross 0.937.

Main results: In the modified ITT population, the primary outcome occurred in 439 (62%) of the tenecteplase group and 405 (68%) of the alteplase group (RR, 1.07; 95% CI, 0.98-1.16). This met the prespecified margin for noninferiority. Intracranial hemorrhage within 36 hours was experienced by 15 (2%) patients in the tenecteplase group and 13 (2%) in the alteplase group (RR, 1.18; 95% CI, 0.56-2.50). Death at 90 days occurred in 46 (7%) patients in the tenecteplase group and 35 (5%) in the alteplase group (RR, 1.31; 95% CI, 0.86-2.01).

Conclusion: Tenecteplase was noninferior to alteplase in patients with acute ischemic stroke who met criteria for thrombolysis and either refused or were ineligible for endovascular thrombectomy.

Commentary

Alteplase has been FDA-approved for managing acute ischemic stroke since 1996 and has demonstrated positive effects on functional outcomes. Drawbacks of alteplase therapy, however, include bleeding risk as well as cumbersome administration of a bolus dose followed by a 60-minute infusion. In recent years, the question of whether or not tenecteplase could replace alteplase as the preferred thrombolytic for acute ischemic stroke has garnered much attention. Several features of tenecteplase make it an attractive option, including increased fibrin specificity, a longer half-life, and ease of administration as a single, rapid bolus dose. In phase 2 trials that compared tenecteplase 0.25 mg/kg with alteplase, findings suggested the potential for early neurological improvement as well as improved outcomes at 90 days. While the role of tenecteplase in acute myocardial infarction has been well established due to ease of use and a favorable adverse-effect profile,¹ there is much less evidence from phase 3 randomized controlled clinical trials to secure the role of tenecteplase in acute ischemic stroke.²

Menon et al attempted to close this gap in the literature by conducting a randomized controlled clinical trial (AcT) comparing tenecteplase to alteplase in a Canadian patient population. The trial's patient population mirrors that of real-world data from global registries in terms of age, sex, and baseline stroke severity. In addition, the eligibility window of 4.5 hours from symptom onset as well as the inclusion and exclusion criteria for therapy are common to those utilized in other countries, making the findings generalizable. There were some limitations to the study, however, including the impact of COVID-19 on recruitment efforts as well as limitations of research infrastructure and staffing, which may have limited enrollment efforts at primary stroke centers. Nonetheless, the authors concluded that their results provide evidence that tenecteplase is comparable to alteplase, with similar functional and safety outcomes.

TRACE-2 focused on an Asian patient population and provided follow up to the dose-ranging TRACE-1 phase 2 trial. TRACE-1 showed that tenecteplase 0.25 mg/kg had a similar safety profile to alteplase 0.9 mg/kg in Chinese patients presenting with acute ischemic stroke. TRACE-2 sought to establish noninferiority of tenecteplase and excluded patients who were ineligible for or refused thrombectomy. Interestingly, the tenecteplase arm, as the authors point out, had numerically greater mortality as well as intracranial hemorrhage, but these differences were not statistically significant between the treatment groups at 90 days. The TRACE-2 results parallel those of AcT, and although there were differences in ethnicity between the 2 trials, the authors cite this as evidence that the results are consistent and provide evidence for the role of tenecteplase in the management of acute ischemic stroke. Limitations of this trial include potential bias from its open-label design, as well as exclusion of patients with more severe strokes eligible for thrombectomy, which may limit generalizability to patients with more disabling strokes who could have a higher risk of intracranial hemorrhage.

Application for Clinical Practice and System Implementation

Across the country, many organizations have adopted the off-label use of tenecteplase for managing fibrinolytic-eligible acute ischemic stroke patients. In most cases, the impetus for change is the ease of dosing and administration of tenecteplase compared to alteplase, while the inclusion and exclusion criteria and overall management remain the same. Timely administration of therapy in stroke is critical. This, along with other time constraints in stroke workflows, the weight-based calculation of alteplase doses, and alteplase’s administration method may lead to medication errors when using this agent to treat patients with acute stroke. The rapid, single-dose administration of tenecteplase removes many barriers that hospitals face when patients may need to be treated and then transferred to another site for further care. Without the worry to “drip and ship,” the completion of administration may allow for timely patient transfer and eliminate the need for monitoring of an infusion during transfer. For some organizations, there may be a potential for drug cost-savings as well as improved metrics, such as door-to-needle time, but the overall effects of switching from alteplase to tenecteplase remain to be seen. Currently, tenecteplase is included in stroke guidelines as a “reasonable choice,” though with a low level of evidence.³ However, these 2 studies support the role of tenecteplase in acute ischemic stroke treatment and may provide a foundation for further studies to establish the role of tenecteplase in the acute ischemic stroke population.

Practice Points

• Tenecteplase may be considered as an alternative to alteplase for acute ischemic stroke for patients who meet eligibility criteria for thrombolytics; this recommendation is included in the most recent stroke guidelines, although tenecteplase has not been demonstrated to be superior to alteplase.
• The ease of administration of tenecteplase as a single intravenous bolus dose represents a benefit compared to alteplase; it is an off-label use, however, and further studies are needed to establish the superiority of tenecteplase in terms of functional and safety outcomes.

– Carol Heunisch, PharmD, BCPS, BCCP
Pharmacy Department, NorthShore–Edward-Elmhurst Health, Evanston, IL

Study 1 Overview (Menon et al)

Objective: To determine whether a 0.25 mg/kg dose of intravenous tenecteplase is noninferior to intravenous alteplase 0.9 mg/kg for patients with acute ischemic stroke eligible for thrombolytic therapy.

Design: Multicenter, parallel-group, open-label randomized controlled trial.

Setting and participants: The trial was conducted at 22 primary and comprehensive stroke centers across Canada. A primary stroke center was defined as a hospital capable of offering intravenous thrombolysis to patients with acute ischemic stroke, while a comprehensive stroke center was able to offer thrombectomy services in addition. The involved centers also participated in Canadian quality improvement registries (either Quality Improvement and Clinical Research [QuiCR] or Optimizing Patient Treatment in Major Ischemic Stroke with EVT [OPTIMISE]) that track patient outcomes. Patients were eligible for inclusion if they were aged 18 years or older, had a diagnosis of acute ischemic stroke, presented within 4.5 hours of symptom onset, and were eligible for thrombolysis according to Canadian guidelines.

Patients were randomized in a 1:1 fashion to either intravenous tenecteplase (0.25 mg/kg single dose, maximum of 25 mg) or intravenous alteplase (0.9 mg/kg total dose to a maximum of 90 mg, delivered as a bolus followed by a continuous infusion). A total of 1600 patients were enrolled, with 816 randomly assigned to the tenecteplase arm and 784 to the alteplase arm; 1577 patients were included in the intention-to-treat (ITT) analysis (n = 806 tenecteplase; n = 771 alteplase). The median age of enrollees was 74 years, and 52.1% of the ITT population were men.

Main outcome measures: In the ITT population, the primary outcome measure was a modified Rankin score (mRS) of 0 or 1 at 90 to 120 days post treatment. Safety outcomes included symptomatic intracerebral hemorrhage, orolingual angioedema, extracranial bleeding that required blood transfusion (all within 24 hours of thrombolytic administration), and all-cause mortality at 90 days. The noninferiority threshold for intravenous tenecteplase was set as the lower 95% CI of the difference between the tenecteplase and alteplase groups in the proportion of patients who met the primary outcome exceeding –5%.

Main results: The primary outcome of mRS of either 0 or 1 at 90 to 120 days of treatment occurred in 296 (36.9%) of the 802 patients assigned to tenecteplase and 266 (34.8%) of the 765 patients assigned to alteplase (unadjusted risk difference, 2.1%; 95% CI, –2.6 to 6.9). The prespecified noninferiority threshold was met. There were no significant differences between the groups in rates of intracerebral hemorrhage at 24 hours or 90-day all-cause mortality.

Conclusion: Intravenous tenecteplase is a reasonable alternative to alteplase for patients eligible for thrombolytic therapy.

Study 2 Overview (Wang et al)

Objective: To determine whether tenecteplase (dose 0.25 mg/kg) is noninferior to alteplase in patients with acute ischemic stroke who are within 4.5 hours of symptom onset and eligible for thrombolytic therapy but either refused or were ineligible for endovascular thrombectomy.

Design: Multicenter, prospective, open-label, randomized, controlled noninferiority trial.

Setting and participants: This trial was conducted at 53 centers across China and included patients 18 years of age or older who were within 4.5 hours of symptom onset and were thrombolytic eligible, had a mRS ≤ 1 at enrollment, and had a National Institutes of Health Stroke Scale score between 5 and 25. Eligible participants were randomized 1:1 to either tenecteplase 0.25 mg/kg (maximum dose 25 mg) or alteplase 0.9 mg/kg (maximum dose 90 mg, administered as a bolus followed by infusion). During the enrollment period (June 12, 2021, to May 29, 2022), a total of 1430 participants were enrolled, and, of those, 716 were randomly assigned to tenecteplase and 714 to alteplase. Six patients assigned to tenecteplase and 7 assigned to alteplase did not receive drugs. At 90 days, 5 in the tenecteplase group and 11 in the alteplase group were lost to follow up.

Main outcome measures: The primary efficacy outcome was a mRS of 0 or 1 at 90 days. The primary safety outcome was intracranial hemorrhage within 36 hours. Safety outcomes included parenchymal hematoma 2, as defined by the European Cooperative Acute Stroke Study III; any intracranial or significant hemorrhage, as defined by the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries criteria; and death from all causes at 90 days. Noninferiority for tenecteplase would be declared if the lower 97.5% 1-sided CI for the relative risk (RR) for the primary outcome did not cross 0.937.

Main results: In the modified ITT population, the primary outcome occurred in 439 (62%) of the tenecteplase group and 405 (68%) of the alteplase group (RR, 1.07; 95% CI, 0.98-1.16). This met the prespecified margin for noninferiority. Intracranial hemorrhage within 36 hours was experienced by 15 (2%) patients in the tenecteplase group and 13 (2%) in the alteplase group (RR, 1.18; 95% CI, 0.56-2.50). Death at 90 days occurred in 46 (7%) patients in the tenecteplase group and 35 (5%) in the alteplase group (RR, 1.31; 95% CI, 0.86-2.01).

Conclusion: Tenecteplase was noninferior to alteplase in patients with acute ischemic stroke who met criteria for thrombolysis and either refused or were ineligible for endovascular thrombectomy.

Commentary

Alteplase has been FDA-approved for managing acute ischemic stroke since 1996 and has demonstrated positive effects on functional outcomes. Drawbacks of alteplase therapy, however, include bleeding risk as well as cumbersome administration of a bolus dose followed by a 60-minute infusion. In recent years, the question of whether or not tenecteplase could replace alteplase as the preferred thrombolytic for acute ischemic stroke has garnered much attention. Several features of tenecteplase make it an attractive option, including increased fibrin specificity, a longer half-life, and ease of administration as a single, rapid bolus dose. In phase 2 trials that compared tenecteplase 0.25 mg/kg with alteplase, findings suggested the potential for early neurological improvement as well as improved outcomes at 90 days. While the role of tenecteplase in acute myocardial infarction has been well established due to ease of use and a favorable adverse-effect profile,¹ there is much less evidence from phase 3 randomized controlled clinical trials to secure the role of tenecteplase in acute ischemic stroke.²

Menon et al attempted to close this gap in the literature by conducting a randomized controlled clinical trial (AcT) comparing tenecteplase to alteplase in a Canadian patient population. The trial's patient population mirrors that of real-world data from global registries in terms of age, sex, and baseline stroke severity. In addition, the eligibility window of 4.5 hours from symptom onset as well as the inclusion and exclusion criteria for therapy are common to those utilized in other countries, making the findings generalizable. There were some limitations to the study, however, including the impact of COVID-19 on recruitment efforts as well as limitations of research infrastructure and staffing, which may have limited enrollment efforts at primary stroke centers. Nonetheless, the authors concluded that their results provide evidence that tenecteplase is comparable to alteplase, with similar functional and safety outcomes.

TRACE-2 focused on an Asian patient population and provided follow up to the dose-ranging TRACE-1 phase 2 trial. TRACE-1 showed that tenecteplase 0.25 mg/kg had a similar safety profile to alteplase 0.9 mg/kg in Chinese patients presenting with acute ischemic stroke. TRACE-2 sought to establish noninferiority of tenecteplase and excluded patients who were ineligible for or refused thrombectomy. Interestingly, the tenecteplase arm, as the authors point out, had numerically greater mortality as well as intracranial hemorrhage, but these differences were not statistically significant between the treatment groups at 90 days. The TRACE-2 results parallel those of AcT, and although there were differences in ethnicity between the 2 trials, the authors cite this as evidence that the results are consistent and provide evidence for the role of tenecteplase in the management of acute ischemic stroke. Limitations of this trial include potential bias from its open-label design, as well as exclusion of patients with more severe strokes eligible for thrombectomy, which may limit generalizability to patients with more disabling strokes who could have a higher risk of intracranial hemorrhage.

Application for Clinical Practice and System Implementation

Across the country, many organizations have adopted the off-label use of tenecteplase for managing fibrinolytic-eligible acute ischemic stroke patients. In most cases, the impetus for change is the ease of dosing and administration of tenecteplase compared to alteplase, while the inclusion and exclusion criteria and overall management remain the same. Timely administration of therapy in stroke is critical. This, along with other time constraints in stroke workflows, the weight-based calculation of alteplase doses, and alteplase’s administration method may lead to medication errors when using this agent to treat patients with acute stroke. The rapid, single-dose administration of tenecteplase removes many barriers that hospitals face when patients may need to be treated and then transferred to another site for further care. Without the worry to “drip and ship,” the completion of administration may allow for timely patient transfer and eliminate the need for monitoring of an infusion during transfer. For some organizations, there may be a potential for drug cost-savings as well as improved metrics, such as door-to-needle time, but the overall effects of switching from alteplase to tenecteplase remain to be seen. Currently, tenecteplase is included in stroke guidelines as a “reasonable choice,” though with a low level of evidence.³ However, these 2 studies support the role of tenecteplase in acute ischemic stroke treatment and may provide a foundation for further studies to establish the role of tenecteplase in the acute ischemic stroke population.

Practice Points

• Tenecteplase may be considered as an alternative to alteplase for acute ischemic stroke for patients who meet eligibility criteria for thrombolytics; this recommendation is included in the most recent stroke guidelines, although tenecteplase has not been demonstrated to be superior to alteplase.
• The ease of administration of tenecteplase as a single intravenous bolus dose represents a benefit compared to alteplase; it is an off-label use, however, and further studies are needed to establish the superiority of tenecteplase in terms of functional and safety outcomes.

– Carol Heunisch, PharmD, BCPS, BCCP
Pharmacy Department, NorthShore–Edward-Elmhurst Health, Evanston, IL

Study 1 Overview (Menon et al)

Objective: To determine whether a 0.25 mg/kg dose of intravenous tenecteplase is noninferior to intravenous alteplase 0.9 mg/kg for patients with acute ischemic stroke eligible for thrombolytic therapy.

Design: Multicenter, parallel-group, open-label randomized controlled trial.

Setting and participants: The trial was conducted at 22 primary and comprehensive stroke centers across Canada. A primary stroke center was defined as a hospital capable of offering intravenous thrombolysis to patients with acute ischemic stroke, while a comprehensive stroke center was able to offer thrombectomy services in addition. The involved centers also participated in Canadian quality improvement registries (either Quality Improvement and Clinical Research [QuiCR] or Optimizing Patient Treatment in Major Ischemic Stroke with EVT [OPTIMISE]) that track patient outcomes. Patients were eligible for inclusion if they were aged 18 years or older, had a diagnosis of acute ischemic stroke, presented within 4.5 hours of symptom onset, and were eligible for thrombolysis according to Canadian guidelines.

Patients were randomized in a 1:1 fashion to either intravenous tenecteplase (0.25 mg/kg single dose, maximum of 25 mg) or intravenous alteplase (0.9 mg/kg total dose to a maximum of 90 mg, delivered as a bolus followed by a continuous infusion). A total of 1600 patients were enrolled, with 816 randomly assigned to the tenecteplase arm and 784 to the alteplase arm; 1577 patients were included in the intention-to-treat (ITT) analysis (n = 806 tenecteplase; n = 771 alteplase). The median age of enrollees was 74 years, and 52.1% of the ITT population were men.

Main outcome measures: In the ITT population, the primary outcome measure was a modified Rankin score (mRS) of 0 or 1 at 90 to 120 days post treatment. Safety outcomes included symptomatic intracerebral hemorrhage, orolingual angioedema, extracranial bleeding that required blood transfusion (all within 24 hours of thrombolytic administration), and all-cause mortality at 90 days. The noninferiority threshold for intravenous tenecteplase was set as the lower 95% CI of the difference between the tenecteplase and alteplase groups in the proportion of patients who met the primary outcome exceeding –5%.

Main results: The primary outcome of mRS of either 0 or 1 at 90 to 120 days of treatment occurred in 296 (36.9%) of the 802 patients assigned to tenecteplase and 266 (34.8%) of the 765 patients assigned to alteplase (unadjusted risk difference, 2.1%; 95% CI, –2.6 to 6.9). The prespecified noninferiority threshold was met. There were no significant differences between the groups in rates of intracerebral hemorrhage at 24 hours or 90-day all-cause mortality.

Conclusion: Intravenous tenecteplase is a reasonable alternative to alteplase for patients eligible for thrombolytic therapy.

Study 2 Overview (Wang et al)

Objective: To determine whether tenecteplase (dose 0.25 mg/kg) is noninferior to alteplase in patients with acute ischemic stroke who are within 4.5 hours of symptom onset and eligible for thrombolytic therapy but either refused or were ineligible for endovascular thrombectomy.

Design: Multicenter, prospective, open-label, randomized, controlled noninferiority trial.

Setting and participants: This trial was conducted at 53 centers across China and included patients 18 years of age or older who were within 4.5 hours of symptom onset and were thrombolytic eligible, had a mRS ≤ 1 at enrollment, and had a National Institutes of Health Stroke Scale score between 5 and 25. Eligible participants were randomized 1:1 to either tenecteplase 0.25 mg/kg (maximum dose 25 mg) or alteplase 0.9 mg/kg (maximum dose 90 mg, administered as a bolus followed by infusion). During the enrollment period (June 12, 2021, to May 29, 2022), a total of 1430 participants were enrolled, and, of those, 716 were randomly assigned to tenecteplase and 714 to alteplase. Six patients assigned to tenecteplase and 7 assigned to alteplase did not receive drugs. At 90 days, 5 in the tenecteplase group and 11 in the alteplase group were lost to follow up.

Main outcome measures: The primary efficacy outcome was a mRS of 0 or 1 at 90 days. The primary safety outcome was intracranial hemorrhage within 36 hours. Safety outcomes included parenchymal hematoma 2, as defined by the European Cooperative Acute Stroke Study III; any intracranial or significant hemorrhage, as defined by the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries criteria; and death from all causes at 90 days. Noninferiority for tenecteplase would be declared if the lower 97.5% 1-sided CI for the relative risk (RR) for the primary outcome did not cross 0.937.

Main results: In the modified ITT population, the primary outcome occurred in 439 (62%) of the tenecteplase group and 405 (68%) of the alteplase group (RR, 1.07; 95% CI, 0.98-1.16). This met the prespecified margin for noninferiority. Intracranial hemorrhage within 36 hours was experienced by 15 (2%) patients in the tenecteplase group and 13 (2%) in the alteplase group (RR, 1.18; 95% CI, 0.56-2.50). Death at 90 days occurred in 46 (7%) patients in the tenecteplase group and 35 (5%) in the alteplase group (RR, 1.31; 95% CI, 0.86-2.01).

Conclusion: Tenecteplase was noninferior to alteplase in patients with acute ischemic stroke who met criteria for thrombolysis and either refused or were ineligible for endovascular thrombectomy.

Commentary

Alteplase has been FDA-approved for managing acute ischemic stroke since 1996 and has demonstrated positive effects on functional outcomes. Drawbacks of alteplase therapy, however, include bleeding risk as well as cumbersome administration of a bolus dose followed by a 60-minute infusion. In recent years, the question of whether or not tenecteplase could replace alteplase as the preferred thrombolytic for acute ischemic stroke has garnered much attention. Several features of tenecteplase make it an attractive option, including increased fibrin specificity, a longer half-life, and ease of administration as a single, rapid bolus dose. In phase 2 trials that compared tenecteplase 0.25 mg/kg with alteplase, findings suggested the potential for early neurological improvement as well as improved outcomes at 90 days. While the role of tenecteplase in acute myocardial infarction has been well established due to ease of use and a favorable adverse-effect profile,¹ there is much less evidence from phase 3 randomized controlled clinical trials to secure the role of tenecteplase in acute ischemic stroke.²

Menon et al attempted to close this gap in the literature by conducting a randomized controlled clinical trial (AcT) comparing tenecteplase to alteplase in a Canadian patient population. The trial's patient population mirrors that of real-world data from global registries in terms of age, sex, and baseline stroke severity. In addition, the eligibility window of 4.5 hours from symptom onset as well as the inclusion and exclusion criteria for therapy are common to those utilized in other countries, making the findings generalizable. There were some limitations to the study, however, including the impact of COVID-19 on recruitment efforts as well as limitations of research infrastructure and staffing, which may have limited enrollment efforts at primary stroke centers. Nonetheless, the authors concluded that their results provide evidence that tenecteplase is comparable to alteplase, with similar functional and safety outcomes.

TRACE-2 focused on an Asian patient population and provided follow up to the dose-ranging TRACE-1 phase 2 trial. TRACE-1 showed that tenecteplase 0.25 mg/kg had a similar safety profile to alteplase 0.9 mg/kg in Chinese patients presenting with acute ischemic stroke. TRACE-2 sought to establish noninferiority of tenecteplase and excluded patients who were ineligible for or refused thrombectomy. Interestingly, the tenecteplase arm, as the authors point out, had numerically greater mortality as well as intracranial hemorrhage, but these differences were not statistically significant between the treatment groups at 90 days. The TRACE-2 results parallel those of AcT, and although there were differences in ethnicity between the 2 trials, the authors cite this as evidence that the results are consistent and provide evidence for the role of tenecteplase in the management of acute ischemic stroke. Limitations of this trial include potential bias from its open-label design, as well as exclusion of patients with more severe strokes eligible for thrombectomy, which may limit generalizability to patients with more disabling strokes who could have a higher risk of intracranial hemorrhage.

Application for Clinical Practice and System Implementation

Across the country, many organizations have adopted the off-label use of tenecteplase for managing fibrinolytic-eligible acute ischemic stroke patients. In most cases, the impetus for change is the ease of dosing and administration of tenecteplase compared to alteplase, while the inclusion and exclusion criteria and overall management remain the same. Timely administration of therapy in stroke is critical. This, along with other time constraints in stroke workflows, the weight-based calculation of alteplase doses, and alteplase’s administration method may lead to medication errors when using this agent to treat patients with acute stroke. The rapid, single-dose administration of tenecteplase removes many barriers that hospitals face when patients may need to be treated and then transferred to another site for further care. Without the worry to “drip and ship,” the completion of administration may allow for timely patient transfer and eliminate the need for monitoring of an infusion during transfer. For some organizations, there may be a potential for drug cost-savings as well as improved metrics, such as door-to-needle time, but the overall effects of switching from alteplase to tenecteplase remain to be seen. Currently, tenecteplase is included in stroke guidelines as a “reasonable choice,” though with a low level of evidence.³ However, these 2 studies support the role of tenecteplase in acute ischemic stroke treatment and may provide a foundation for further studies to establish the role of tenecteplase in the acute ischemic stroke population.

Practice Points

• Tenecteplase may be considered as an alternative to alteplase for acute ischemic stroke for patients who meet eligibility criteria for thrombolytics; this recommendation is included in the most recent stroke guidelines, although tenecteplase has not been demonstrated to be superior to alteplase.
• The ease of administration of tenecteplase as a single intravenous bolus dose represents a benefit compared to alteplase; it is an off-label use, however, and further studies are needed to establish the superiority of tenecteplase in terms of functional and safety outcomes.

– Carol Heunisch, PharmD, BCPS, BCCP
Pharmacy Department, NorthShore–Edward-Elmhurst Health, Evanston, IL

Both tooth loss and diabetes can lead to accelerated cognitive decline in older adults, most specifically in those 65-74 years of age, new findings suggest.

The data come from a 12-year follow-up of older adults in a nationally representative U.S. survey.

“From a clinical perspective, our study demonstrates the importance of improving access to dental health care and integrating primary dental and medical care. Health care professionals and family caregivers should pay close attention to the cognitive status of diabetic older adults with poor oral health status,” lead author Bei Wu, PhD, of New York University, said in an interview. Dr. Wu is the Dean’s Professor in Global Health and codirector of the NYU Aging Incubator.

Moreover, said Dr. Wu: “For individuals with both poor oral health and diabetes, regular dental visits should be encouraged in addition to adherence to the diabetes self-care protocol.”

Diabetes has long been recognized as a risk factor for cognitive decline, but the findings have been inconsistent for different age groups. Tooth loss has also been linked to cognitive decline and dementia, as well as diabetes.

The mechanisms aren’t entirely clear, but “co-occurring diabetes and poor oral health may increase the risk for dementia, possibly via the potentially interrelated pathways of chronic inflammation and cardiovascular risk factors,” Dr. Wu said.

The new study, published in the Journal of Dental Research, is the first to examine the relationships between all three conditions by age group.  
 

Diabetes, edentulism, and cognitive decline

The data came from a total of 9,948 participants in the Health and Retirement Study (HRS) from 2006 to 2018. At baseline, 5,440 participants were aged 65-74 years, 3,300 were aged 75-84, and 1,208 were aged 85 years or older.

They were assessed every 2 years using the 35-point Telephone Survey for Cognitive Status, which included tests of immediate and delayed word recall, repeated subtracting by 7, counting backward from 20, naming objects, and naming the president and vice president of the U.S. As might be expected, the youngest group scored the highest, averaging 23 points, while the oldest group scored lowest, at 18.5 points.

Participants were also asked if they had ever been told by a doctor that they have diabetes. Another question was: “Have you lost all of your upper and lower natural permanent teeth?”

The condition of having no teeth is known as edentulism.

The percentages of participants who reported having both diabetes and edentulism were 6.0%, 6.7%, and 5.0% for those aged 65-74 years, 75-84 years, and 85 years or older, respectively. The proportions with neither of those conditions were 63.5%, 60.4%, and 58.3% in those three age groups, respectively (P < .001).

Compared with their counterparts with neither diabetes nor edentulism at baseline, older adults with both conditions aged 65-74 years (P < .001) and aged 75-84 years had worse cognitive function (P < .001).

In terms of the rate of cognitive decline, compared with those with neither condition from the same age cohort, older adults aged 65-74 years with both conditions declined at a higher rate (P < .001).

Having diabetes alone led to accelerated cognitive decline in older adults aged 65-74 years (P < .001). Having edentulism alone led to accelerated decline in older adults aged 65-74 years (P < .001) and older adults aged 75-84 years (P < 0.01).

“Our study finds the co-occurrence of diabetes and edentulism led to a worse cognitive function and a faster cognitive decline in older adults aged 65-74 years,” say Wu and colleagues.
 

Study limitations: Better data needed

The study has several limitations, most of them due to the data source. For example, while the HRS collects detailed information on cognitive status, edentulism is its only measure of oral health. There were no data on whether individuals had replacements such as dentures or implants that would affect their ability to eat, which could influence other health factors.

“I have made repeated appeals for federal funding to collect more oral health-related information in large national surveys,” Dr. Wu told this news organization.

Similarly, assessments of diabetes status such as hemoglobin A1c were only available for small subsets and not sufficient to demonstrate statistical significance, she explained.

Dr. Wu suggested that both oral health and cognitive screening might be included in the “Welcome to Medicare” preventive visit. In addition, “Oral hygiene practice should also be highlighted to improve cognitive health. Developing dental care interventions and programs are needed for reducing the societal cost of dementia.”

The study was partially supported by the National Institutes of Health. The authors have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Both tooth loss and diabetes can lead to accelerated cognitive decline in older adults, most specifically in those 65-74 years of age, new findings suggest.

The data come from a 12-year follow-up of older adults in a nationally representative U.S. survey.

“From a clinical perspective, our study demonstrates the importance of improving access to dental health care and integrating primary dental and medical care. Health care professionals and family caregivers should pay close attention to the cognitive status of diabetic older adults with poor oral health status,” lead author Bei Wu, PhD, of New York University, said in an interview. Dr. Wu is the Dean’s Professor in Global Health and codirector of the NYU Aging Incubator.

Moreover, said Dr. Wu: “For individuals with both poor oral health and diabetes, regular dental visits should be encouraged in addition to adherence to the diabetes self-care protocol.”

Diabetes has long been recognized as a risk factor for cognitive decline, but the findings have been inconsistent for different age groups. Tooth loss has also been linked to cognitive decline and dementia, as well as diabetes.

The mechanisms aren’t entirely clear, but “co-occurring diabetes and poor oral health may increase the risk for dementia, possibly via the potentially interrelated pathways of chronic inflammation and cardiovascular risk factors,” Dr. Wu said.

The new study, published in the Journal of Dental Research, is the first to examine the relationships between all three conditions by age group.  
 

Diabetes, edentulism, and cognitive decline

The data came from a total of 9,948 participants in the Health and Retirement Study (HRS) from 2006 to 2018. At baseline, 5,440 participants were aged 65-74 years, 3,300 were aged 75-84, and 1,208 were aged 85 years or older.

They were assessed every 2 years using the 35-point Telephone Survey for Cognitive Status, which included tests of immediate and delayed word recall, repeated subtracting by 7, counting backward from 20, naming objects, and naming the president and vice president of the U.S. As might be expected, the youngest group scored the highest, averaging 23 points, while the oldest group scored lowest, at 18.5 points.

Participants were also asked if they had ever been told by a doctor that they have diabetes. Another question was: “Have you lost all of your upper and lower natural permanent teeth?”

The condition of having no teeth is known as edentulism.

The percentages of participants who reported having both diabetes and edentulism were 6.0%, 6.7%, and 5.0% for those aged 65-74 years, 75-84 years, and 85 years or older, respectively. The proportions with neither of those conditions were 63.5%, 60.4%, and 58.3% in those three age groups, respectively (P < .001).

Compared with their counterparts with neither diabetes nor edentulism at baseline, older adults with both conditions aged 65-74 years (P < .001) and aged 75-84 years had worse cognitive function (P < .001).

In terms of the rate of cognitive decline, compared with those with neither condition from the same age cohort, older adults aged 65-74 years with both conditions declined at a higher rate (P < .001).

Having diabetes alone led to accelerated cognitive decline in older adults aged 65-74 years (P < .001). Having edentulism alone led to accelerated decline in older adults aged 65-74 years (P < .001) and older adults aged 75-84 years (P < 0.01).

“Our study finds the co-occurrence of diabetes and edentulism led to a worse cognitive function and a faster cognitive decline in older adults aged 65-74 years,” say Wu and colleagues.
 

Study limitations: Better data needed

The study has several limitations, most of them due to the data source. For example, while the HRS collects detailed information on cognitive status, edentulism is its only measure of oral health. There were no data on whether individuals had replacements such as dentures or implants that would affect their ability to eat, which could influence other health factors.

“I have made repeated appeals for federal funding to collect more oral health-related information in large national surveys,” Dr. Wu told this news organization.

Similarly, assessments of diabetes status such as hemoglobin A1c were only available for small subsets and not sufficient to demonstrate statistical significance, she explained.

Dr. Wu suggested that both oral health and cognitive screening might be included in the “Welcome to Medicare” preventive visit. In addition, “Oral hygiene practice should also be highlighted to improve cognitive health. Developing dental care interventions and programs are needed for reducing the societal cost of dementia.”

The study was partially supported by the National Institutes of Health. The authors have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Both tooth loss and diabetes can lead to accelerated cognitive decline in older adults, most specifically in those 65-74 years of age, new findings suggest.

The data come from a 12-year follow-up of older adults in a nationally representative U.S. survey.

“From a clinical perspective, our study demonstrates the importance of improving access to dental health care and integrating primary dental and medical care. Health care professionals and family caregivers should pay close attention to the cognitive status of diabetic older adults with poor oral health status,” lead author Bei Wu, PhD, of New York University, said in an interview. Dr. Wu is the Dean’s Professor in Global Health and codirector of the NYU Aging Incubator.

Moreover, said Dr. Wu: “For individuals with both poor oral health and diabetes, regular dental visits should be encouraged in addition to adherence to the diabetes self-care protocol.”

Diabetes has long been recognized as a risk factor for cognitive decline, but the findings have been inconsistent for different age groups. Tooth loss has also been linked to cognitive decline and dementia, as well as diabetes.

The mechanisms aren’t entirely clear, but “co-occurring diabetes and poor oral health may increase the risk for dementia, possibly via the potentially interrelated pathways of chronic inflammation and cardiovascular risk factors,” Dr. Wu said.

The new study, published in the Journal of Dental Research, is the first to examine the relationships between all three conditions by age group.  
 

Diabetes, edentulism, and cognitive decline

The data came from a total of 9,948 participants in the Health and Retirement Study (HRS) from 2006 to 2018. At baseline, 5,440 participants were aged 65-74 years, 3,300 were aged 75-84, and 1,208 were aged 85 years or older.

They were assessed every 2 years using the 35-point Telephone Survey for Cognitive Status, which included tests of immediate and delayed word recall, repeated subtracting by 7, counting backward from 20, naming objects, and naming the president and vice president of the U.S. As might be expected, the youngest group scored the highest, averaging 23 points, while the oldest group scored lowest, at 18.5 points.

Participants were also asked if they had ever been told by a doctor that they have diabetes. Another question was: “Have you lost all of your upper and lower natural permanent teeth?”

The condition of having no teeth is known as edentulism.

The percentages of participants who reported having both diabetes and edentulism were 6.0%, 6.7%, and 5.0% for those aged 65-74 years, 75-84 years, and 85 years or older, respectively. The proportions with neither of those conditions were 63.5%, 60.4%, and 58.3% in those three age groups, respectively (P < .001).

Compared with their counterparts with neither diabetes nor edentulism at baseline, older adults with both conditions aged 65-74 years (P < .001) and aged 75-84 years had worse cognitive function (P < .001).

In terms of the rate of cognitive decline, compared with those with neither condition from the same age cohort, older adults aged 65-74 years with both conditions declined at a higher rate (P < .001).

Having diabetes alone led to accelerated cognitive decline in older adults aged 65-74 years (P < .001). Having edentulism alone led to accelerated decline in older adults aged 65-74 years (P < .001) and older adults aged 75-84 years (P < 0.01).

“Our study finds the co-occurrence of diabetes and edentulism led to a worse cognitive function and a faster cognitive decline in older adults aged 65-74 years,” say Wu and colleagues.
 

Study limitations: Better data needed

The study has several limitations, most of them due to the data source. For example, while the HRS collects detailed information on cognitive status, edentulism is its only measure of oral health. There were no data on whether individuals had replacements such as dentures or implants that would affect their ability to eat, which could influence other health factors.

“I have made repeated appeals for federal funding to collect more oral health-related information in large national surveys,” Dr. Wu told this news organization.

Similarly, assessments of diabetes status such as hemoglobin A1c were only available for small subsets and not sufficient to demonstrate statistical significance, she explained.

Dr. Wu suggested that both oral health and cognitive screening might be included in the “Welcome to Medicare” preventive visit. In addition, “Oral hygiene practice should also be highlighted to improve cognitive health. Developing dental care interventions and programs are needed for reducing the societal cost of dementia.”

The study was partially supported by the National Institutes of Health. The authors have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

People with epilepsy have a twofold increased risk for death, compared with their counterparts without the condition, irrespective of comorbidities or disease severity, new research shows.

“To our knowledge, this is the only study that has assessed the cause-specific mortality risk among people with epilepsy according to age and disease course,” investigators led by Seo-Young Lee, MD, PhD, of Kangwon National University, Chuncheon, South Korea, write. “Understanding cause-specific mortality risk, particularly the risk of external causes, is important because they are mostly preventable.”

The findings were published online  in Neurology.
 

Higher mortality risk

For the study, researchers analyzed data from the National Health Insurance Service database in Korea from 2006 to 2017 and vital statistics from Statistics Korea from 2008 to 2017.

The study population included 138,998 patients with newly treated epilepsy, with an average at diagnosis of 48.6 years.

Over 665,928 person years of follow-up (mean follow-up, 4.79 years), 20.095 patients died.

People with epilepsy had more than twice the risk for death, compared with the overall population (standardized mortality ratio, 2.25; 95% confidence interval, 2.22-2.28). Mortality was highest in children aged 4 years or younger and was higher in the first year after diagnosis and in women at all age points.

People with epilepsy had a higher mortality risk, compared with the general public, regardless of how many anti-seizure medications they were taking. Those taking only one medication had a 156% higher risk for death (SMR, 1.56; 95% CI, 1.53-1.60), compared with 493% higher risk in those taking four or more medications (SMR, 4.93; 95% CI, 4.76-5.10).

Where patients lived also played a role in mortality risk. Living in a rural area was associated with a 247% higher risk for death, compared with people without epilepsy who lived in the same area (SMR, 2.47; 95% CI, 2.41-2.53), and the risk was 203% higher risk among those living in urban centers (SMR, 2.03; 95% CI, 1.98-2.09).

Although people with comorbidities had higher mortality rates, even those without any other health conditions had a 161% higher risk for death, compared with people without epilepsy (SMR, 1.61; 95% CI, 1.50-1.72).
 

Causes of death

The most frequent causes of death were malignant neoplasm and cerebrovascular disease, which researchers noted are thought to be underlying causes of epilepsy.

Among external causes of death, suicide was the most common cause (2.6%). The suicide rate was highest among younger patients and gradually decreased with age.

Deaths tied directly to epilepsy, transport accidents, or falls were lower in this study than had been previously reported, which may be due to adequate seizure control or because the number of older people with epilepsy and comorbidities is higher in Korea than that reported in other countries.

“To reduce mortality in people with epilepsy, comprehensive efforts [are needed], including a national policy against stigma of epilepsy and clinicians’ total management such as risk stratification, education about injury prevention, and monitoring for suicidal ideation with psychological intervention, as well as active control of seizures,” the authors write.
 

Generalizable findings

Joseph Sirven, MD, professor of neurology at Mayo Clinic Florida, Jacksonville, said that although the study included only Korean patients, the findings are applicable to other counties.

That researchers found patients with epilepsy were more than twice as likely to die prematurely, compared with the general population wasn’t particularly surprising, Dr. Sirven said.

“What struck me the most was the fact that even patients who were on a single drug and seemingly well controlled also had excess mortality reported,” Dr. Sirven said. “That these risks occur should be part of what we tell all patients with epilepsy so that they can better arm themselves with information and help to address some of the risks that this study showed.”

Another important finding is the risk for suicide in patients with epilepsy, especially those who are newly diagnosed, he said.

“When we treat a patient with epilepsy, it should not just be about seizures, but we need to inquire about the psychiatric comorbidities and more importantly manage them in a comprehensive manner,” Dr. Sirven said.

The study was funded by Soonchunhyang University Research Fund and the Korea Health Technology R&D Project. The study authors and Dr. Sirven report no relevant financial conflicts.

A version of this article first appeared on Medscape.com.

People with epilepsy have a twofold increased risk for death, compared with their counterparts without the condition, irrespective of comorbidities or disease severity, new research shows.

“To our knowledge, this is the only study that has assessed the cause-specific mortality risk among people with epilepsy according to age and disease course,” investigators led by Seo-Young Lee, MD, PhD, of Kangwon National University, Chuncheon, South Korea, write. “Understanding cause-specific mortality risk, particularly the risk of external causes, is important because they are mostly preventable.”

The findings were published online  in Neurology.
 

Higher mortality risk

For the study, researchers analyzed data from the National Health Insurance Service database in Korea from 2006 to 2017 and vital statistics from Statistics Korea from 2008 to 2017.

The study population included 138,998 patients with newly treated epilepsy, with an average at diagnosis of 48.6 years.

Over 665,928 person years of follow-up (mean follow-up, 4.79 years), 20.095 patients died.

People with epilepsy had more than twice the risk for death, compared with the overall population (standardized mortality ratio, 2.25; 95% confidence interval, 2.22-2.28). Mortality was highest in children aged 4 years or younger and was higher in the first year after diagnosis and in women at all age points.

People with epilepsy had a higher mortality risk, compared with the general public, regardless of how many anti-seizure medications they were taking. Those taking only one medication had a 156% higher risk for death (SMR, 1.56; 95% CI, 1.53-1.60), compared with 493% higher risk in those taking four or more medications (SMR, 4.93; 95% CI, 4.76-5.10).

Where patients lived also played a role in mortality risk. Living in a rural area was associated with a 247% higher risk for death, compared with people without epilepsy who lived in the same area (SMR, 2.47; 95% CI, 2.41-2.53), and the risk was 203% higher risk among those living in urban centers (SMR, 2.03; 95% CI, 1.98-2.09).

Although people with comorbidities had higher mortality rates, even those without any other health conditions had a 161% higher risk for death, compared with people without epilepsy (SMR, 1.61; 95% CI, 1.50-1.72).
 

Causes of death

The most frequent causes of death were malignant neoplasm and cerebrovascular disease, which researchers noted are thought to be underlying causes of epilepsy.

Among external causes of death, suicide was the most common cause (2.6%). The suicide rate was highest among younger patients and gradually decreased with age.

Deaths tied directly to epilepsy, transport accidents, or falls were lower in this study than had been previously reported, which may be due to adequate seizure control or because the number of older people with epilepsy and comorbidities is higher in Korea than that reported in other countries.

“To reduce mortality in people with epilepsy, comprehensive efforts [are needed], including a national policy against stigma of epilepsy and clinicians’ total management such as risk stratification, education about injury prevention, and monitoring for suicidal ideation with psychological intervention, as well as active control of seizures,” the authors write.
 

Generalizable findings

Joseph Sirven, MD, professor of neurology at Mayo Clinic Florida, Jacksonville, said that although the study included only Korean patients, the findings are applicable to other counties.

That researchers found patients with epilepsy were more than twice as likely to die prematurely, compared with the general population wasn’t particularly surprising, Dr. Sirven said.

“What struck me the most was the fact that even patients who were on a single drug and seemingly well controlled also had excess mortality reported,” Dr. Sirven said. “That these risks occur should be part of what we tell all patients with epilepsy so that they can better arm themselves with information and help to address some of the risks that this study showed.”

Another important finding is the risk for suicide in patients with epilepsy, especially those who are newly diagnosed, he said.

“When we treat a patient with epilepsy, it should not just be about seizures, but we need to inquire about the psychiatric comorbidities and more importantly manage them in a comprehensive manner,” Dr. Sirven said.

The study was funded by Soonchunhyang University Research Fund and the Korea Health Technology R&D Project. The study authors and Dr. Sirven report no relevant financial conflicts.

A version of this article first appeared on Medscape.com.

People with epilepsy have a twofold increased risk for death, compared with their counterparts without the condition, irrespective of comorbidities or disease severity, new research shows.

“To our knowledge, this is the only study that has assessed the cause-specific mortality risk among people with epilepsy according to age and disease course,” investigators led by Seo-Young Lee, MD, PhD, of Kangwon National University, Chuncheon, South Korea, write. “Understanding cause-specific mortality risk, particularly the risk of external causes, is important because they are mostly preventable.”

The findings were published online  in Neurology.
 

Higher mortality risk

For the study, researchers analyzed data from the National Health Insurance Service database in Korea from 2006 to 2017 and vital statistics from Statistics Korea from 2008 to 2017.

The study population included 138,998 patients with newly treated epilepsy, with an average at diagnosis of 48.6 years.

Over 665,928 person years of follow-up (mean follow-up, 4.79 years), 20.095 patients died.

People with epilepsy had more than twice the risk for death, compared with the overall population (standardized mortality ratio, 2.25; 95% confidence interval, 2.22-2.28). Mortality was highest in children aged 4 years or younger and was higher in the first year after diagnosis and in women at all age points.

People with epilepsy had a higher mortality risk, compared with the general public, regardless of how many anti-seizure medications they were taking. Those taking only one medication had a 156% higher risk for death (SMR, 1.56; 95% CI, 1.53-1.60), compared with 493% higher risk in those taking four or more medications (SMR, 4.93; 95% CI, 4.76-5.10).

Where patients lived also played a role in mortality risk. Living in a rural area was associated with a 247% higher risk for death, compared with people without epilepsy who lived in the same area (SMR, 2.47; 95% CI, 2.41-2.53), and the risk was 203% higher risk among those living in urban centers (SMR, 2.03; 95% CI, 1.98-2.09).

Although people with comorbidities had higher mortality rates, even those without any other health conditions had a 161% higher risk for death, compared with people without epilepsy (SMR, 1.61; 95% CI, 1.50-1.72).
 

Causes of death

The most frequent causes of death were malignant neoplasm and cerebrovascular disease, which researchers noted are thought to be underlying causes of epilepsy.

Among external causes of death, suicide was the most common cause (2.6%). The suicide rate was highest among younger patients and gradually decreased with age.

Deaths tied directly to epilepsy, transport accidents, or falls were lower in this study than had been previously reported, which may be due to adequate seizure control or because the number of older people with epilepsy and comorbidities is higher in Korea than that reported in other countries.

“To reduce mortality in people with epilepsy, comprehensive efforts [are needed], including a national policy against stigma of epilepsy and clinicians’ total management such as risk stratification, education about injury prevention, and monitoring for suicidal ideation with psychological intervention, as well as active control of seizures,” the authors write.
 

Generalizable findings

Joseph Sirven, MD, professor of neurology at Mayo Clinic Florida, Jacksonville, said that although the study included only Korean patients, the findings are applicable to other counties.

That researchers found patients with epilepsy were more than twice as likely to die prematurely, compared with the general population wasn’t particularly surprising, Dr. Sirven said.

“What struck me the most was the fact that even patients who were on a single drug and seemingly well controlled also had excess mortality reported,” Dr. Sirven said. “That these risks occur should be part of what we tell all patients with epilepsy so that they can better arm themselves with information and help to address some of the risks that this study showed.”

Another important finding is the risk for suicide in patients with epilepsy, especially those who are newly diagnosed, he said.

“When we treat a patient with epilepsy, it should not just be about seizures, but we need to inquire about the psychiatric comorbidities and more importantly manage them in a comprehensive manner,” Dr. Sirven said.

The study was funded by Soonchunhyang University Research Fund and the Korea Health Technology R&D Project. The study authors and Dr. Sirven report no relevant financial conflicts.

A version of this article first appeared on Medscape.com.

Emergency nurse Stephanee Beggs, RN, BSN, has made more than $2 million in three years selling her handwritten guides to study for the National Council Licensure Examination (NCLEX).

Ms. Beggs, 28, sells one-page study sheets or bundles of sheets, sometimes with colorful drawings, conversation bubbles and underlining, that boil down concepts for particular conditions into easy-to-understand language.

The biggest seller on Ms. Beggs’ online marketplace Etsy site, RNExplained, is a bundle of study guides covering eight core nursing classes. The notes range in price from $2 to $150. More than 70,000 customers have bought the $60 bundle, according to the website.

Ms. Beggs’ business developed in a “very unintentional” way when COVID hit with just months left in her nursing program at Mount Saint Mary’s University, Los Angeles, she told this news organization.

Classes had switched to Zoom, and she had no one to study with as she prepared to take her board exams.

“The best way I know how to study is to teach things out loud. But because I had nobody to teach out loud to, I would literally teach them to the wall,” Ms. Beggs said. “I would record myself so I could play it back and teach myself these topics that were hard for me to understand.”

Just for fun, she says, she posted them on TikTok and the responses started flowing in, with followers asking where she was selling the sheets. She now has more than 660,000 TikTok followers and 9 million likes.

Ms. Beggs said that every sheet highlights a condition, and she has made 308 of them.

Traditional classroom lessons typically teach one medical condition in 5-6 pages, Ms. Beggs said. “I go straight to the point.”

One reviewer on Ms. Beggs’ Etsy site appreciated the handwritten notes, calling them “simplified and concise.” Another commented: “Definitely helped me pass my last exam.”

Ms. Beggs says that her notes may seem simple, but each page represents comprehensive research.

“I have to go through not just one source of information to make sure my information is factual,” Ms. Beggs says. “What you teach in California might be a little different than what you teach in Florida. It’s very meticulous. The lab values will be a little different everywhere you go.”

She acknowledges her competition, noting that there are many other study guides for the NCLEX and nursing courses.
 

Nursing groups weigh in

Dawn Kappel, spokesperson for the National Council of State Boards of Nursing, which oversees NCLEX, said in an interview that “NCSBN has no issue with the current content of Stephanee Beggs’ business venture.”

For many students, the study guides will be helpful, especially for visual learners, said Carole Kenner, PhD, RN, dean and professor in the School of Nursing and Health Sciences at The College of New Jersey.

But for students “who are less confident in their knowledge, I would want to see a lot more in-depth explanation and rationale,” Dr. Kenner said.

“Since the NCLEX is moving to more cased-based scenarios, the next-gen unfolding cases, you really have to understand a lot of the rationale.”

The notes remind Dr. Kenner of traditional flash cards. “I don’t think it will work for all students, but even the fanciest of onsite review courses are useful to everyone,” she said.
 

‘Not cutting corners’

As an emergency nurse, Ms. Beggs said, “I have the experience as a nurse to show people that what you are learning will be seen in real life.”

“The way I teach my brand is not to take shortcuts. I love to teach to understand rather than teaching to memorize for an exam.”

She said she sees her guides as a supplement to learning, not a replacement.

“It’s not cutting corners,” she says. “I condense a medical condition that could take a very long time to understand and break it into layman’s terms.”

Ms. Beggs said when people hear about the $2 million, they often ask her whether she plans to give up her shifts in the emergency department for the more lucrative venture.

The answer is no, at least not yet.

“Aside from teaching, I genuinely love being at the bedside,” Ms. Beggs said. “I don’t foresee myself leaving that for good for as long as I can handle both.” She acknowledged, though, that her business now takes up most of her time.  

“I love everything about both aspects, so it’s hard for me to choose.”

A version of this article first appeared on Medscape.com.

Emergency nurse Stephanee Beggs, RN, BSN, has made more than $2 million in three years selling her handwritten guides to study for the National Council Licensure Examination (NCLEX).

Ms. Beggs, 28, sells one-page study sheets or bundles of sheets, sometimes with colorful drawings, conversation bubbles and underlining, that boil down concepts for particular conditions into easy-to-understand language.

The biggest seller on Ms. Beggs’ online marketplace Etsy site, RNExplained, is a bundle of study guides covering eight core nursing classes. The notes range in price from $2 to $150. More than 70,000 customers have bought the $60 bundle, according to the website.

Ms. Beggs’ business developed in a “very unintentional” way when COVID hit with just months left in her nursing program at Mount Saint Mary’s University, Los Angeles, she told this news organization.

Classes had switched to Zoom, and she had no one to study with as she prepared to take her board exams.

“The best way I know how to study is to teach things out loud. But because I had nobody to teach out loud to, I would literally teach them to the wall,” Ms. Beggs said. “I would record myself so I could play it back and teach myself these topics that were hard for me to understand.”

Just for fun, she says, she posted them on TikTok and the responses started flowing in, with followers asking where she was selling the sheets. She now has more than 660,000 TikTok followers and 9 million likes.

Ms. Beggs said that every sheet highlights a condition, and she has made 308 of them.

Traditional classroom lessons typically teach one medical condition in 5-6 pages, Ms. Beggs said. “I go straight to the point.”

One reviewer on Ms. Beggs’ Etsy site appreciated the handwritten notes, calling them “simplified and concise.” Another commented: “Definitely helped me pass my last exam.”

Ms. Beggs says that her notes may seem simple, but each page represents comprehensive research.

“I have to go through not just one source of information to make sure my information is factual,” Ms. Beggs says. “What you teach in California might be a little different than what you teach in Florida. It’s very meticulous. The lab values will be a little different everywhere you go.”

She acknowledges her competition, noting that there are many other study guides for the NCLEX and nursing courses.
 

Nursing groups weigh in

Dawn Kappel, spokesperson for the National Council of State Boards of Nursing, which oversees NCLEX, said in an interview that “NCSBN has no issue with the current content of Stephanee Beggs’ business venture.”

For many students, the study guides will be helpful, especially for visual learners, said Carole Kenner, PhD, RN, dean and professor in the School of Nursing and Health Sciences at The College of New Jersey.

But for students “who are less confident in their knowledge, I would want to see a lot more in-depth explanation and rationale,” Dr. Kenner said.

“Since the NCLEX is moving to more cased-based scenarios, the next-gen unfolding cases, you really have to understand a lot of the rationale.”

The notes remind Dr. Kenner of traditional flash cards. “I don’t think it will work for all students, but even the fanciest of onsite review courses are useful to everyone,” she said.
 

‘Not cutting corners’

As an emergency nurse, Ms. Beggs said, “I have the experience as a nurse to show people that what you are learning will be seen in real life.”

“The way I teach my brand is not to take shortcuts. I love to teach to understand rather than teaching to memorize for an exam.”

She said she sees her guides as a supplement to learning, not a replacement.

“It’s not cutting corners,” she says. “I condense a medical condition that could take a very long time to understand and break it into layman’s terms.”

Ms. Beggs said when people hear about the $2 million, they often ask her whether she plans to give up her shifts in the emergency department for the more lucrative venture.

The answer is no, at least not yet.

“Aside from teaching, I genuinely love being at the bedside,” Ms. Beggs said. “I don’t foresee myself leaving that for good for as long as I can handle both.” She acknowledged, though, that her business now takes up most of her time.  

“I love everything about both aspects, so it’s hard for me to choose.”

A version of this article first appeared on Medscape.com.

Emergency nurse Stephanee Beggs, RN, BSN, has made more than $2 million in three years selling her handwritten guides to study for the National Council Licensure Examination (NCLEX).

Ms. Beggs, 28, sells one-page study sheets or bundles of sheets, sometimes with colorful drawings, conversation bubbles and underlining, that boil down concepts for particular conditions into easy-to-understand language.

The biggest seller on Ms. Beggs’ online marketplace Etsy site, RNExplained, is a bundle of study guides covering eight core nursing classes. The notes range in price from $2 to $150. More than 70,000 customers have bought the $60 bundle, according to the website.

Ms. Beggs’ business developed in a “very unintentional” way when COVID hit with just months left in her nursing program at Mount Saint Mary’s University, Los Angeles, she told this news organization.

Classes had switched to Zoom, and she had no one to study with as she prepared to take her board exams.

“The best way I know how to study is to teach things out loud. But because I had nobody to teach out loud to, I would literally teach them to the wall,” Ms. Beggs said. “I would record myself so I could play it back and teach myself these topics that were hard for me to understand.”

Just for fun, she says, she posted them on TikTok and the responses started flowing in, with followers asking where she was selling the sheets. She now has more than 660,000 TikTok followers and 9 million likes.

Ms. Beggs said that every sheet highlights a condition, and she has made 308 of them.

Traditional classroom lessons typically teach one medical condition in 5-6 pages, Ms. Beggs said. “I go straight to the point.”

One reviewer on Ms. Beggs’ Etsy site appreciated the handwritten notes, calling them “simplified and concise.” Another commented: “Definitely helped me pass my last exam.”

Ms. Beggs says that her notes may seem simple, but each page represents comprehensive research.

“I have to go through not just one source of information to make sure my information is factual,” Ms. Beggs says. “What you teach in California might be a little different than what you teach in Florida. It’s very meticulous. The lab values will be a little different everywhere you go.”

She acknowledges her competition, noting that there are many other study guides for the NCLEX and nursing courses.
 

Nursing groups weigh in

Dawn Kappel, spokesperson for the National Council of State Boards of Nursing, which oversees NCLEX, said in an interview that “NCSBN has no issue with the current content of Stephanee Beggs’ business venture.”

For many students, the study guides will be helpful, especially for visual learners, said Carole Kenner, PhD, RN, dean and professor in the School of Nursing and Health Sciences at The College of New Jersey.

But for students “who are less confident in their knowledge, I would want to see a lot more in-depth explanation and rationale,” Dr. Kenner said.

“Since the NCLEX is moving to more cased-based scenarios, the next-gen unfolding cases, you really have to understand a lot of the rationale.”

The notes remind Dr. Kenner of traditional flash cards. “I don’t think it will work for all students, but even the fanciest of onsite review courses are useful to everyone,” she said.
 

‘Not cutting corners’

As an emergency nurse, Ms. Beggs said, “I have the experience as a nurse to show people that what you are learning will be seen in real life.”

“The way I teach my brand is not to take shortcuts. I love to teach to understand rather than teaching to memorize for an exam.”

She said she sees her guides as a supplement to learning, not a replacement.

“It’s not cutting corners,” she says. “I condense a medical condition that could take a very long time to understand and break it into layman’s terms.”

Ms. Beggs said when people hear about the $2 million, they often ask her whether she plans to give up her shifts in the emergency department for the more lucrative venture.

The answer is no, at least not yet.

“Aside from teaching, I genuinely love being at the bedside,” Ms. Beggs said. “I don’t foresee myself leaving that for good for as long as I can handle both.” She acknowledged, though, that her business now takes up most of her time.  

“I love everything about both aspects, so it’s hard for me to choose.”

A version of this article first appeared on Medscape.com.

Lab work was ordered and came back within normal range, except for an elevated white blood cell count (19,700/mm³; reference range, 4500-13,500/mm³). His mild systemic symptoms, skin lesions without blistering or necrosis, acral edema, and the absence of lymphadenopathy pointed to a diagnosis of urticaria multiforme.

Urticaria multiforme, also called acute annular urticaria or acute urticarial hypersensitivity syndrome, is a histamine-mediated hypersensitivity reaction characterized by transient annular, polycyclic, urticarial lesions with central ecchymosis. It typically manifests in children ages 4 months to 4 years and begins with small erythematous macules, papules, and plaques that progress to large blanchable wheals with dusky blue centers.^1-3 Lesions are usually located on the face, trunk, and extremities and are often pruritic (60%-94%).^1-3 The rash generally lasts 2 to 12 days.^1,3

Patients often report a preceding viral illness, otitis media, recent use of antibiotics, or recent immunizations. Patients also often have associated facial or acral edema (72%).¹ Children with significant edema of the feet may find walking difficult, which should not be confused with arthritis or arthralgias.

The diagnosis is made clinically and should not require a skin biopsy or extensive laboratory testing. When performed, laboratory studies—including CBC, erythrocyte sedimentation rate, C-reactive protein, and urinalysis—are routinely normal. The differential diagnosis in this case included erythema multiforme, Henoch-Schönlein purpura, serum sickness-like reaction, and urticarial vasculitis.^1,2,4

Treatment consists of discontinuing any offending agent (if suspected) and using systemic H1 or H2 antihistamines for symptom relief. Systemic steroids should only be given in refractory cases.

Our patient’s amoxicillin was discontinued, and he was started on a 14-day course of cetirizine 5 mg bid and hydroxyzine 10 mg at bedtime. He was also started on triamcinolone 0.1% cream to be applied twice daily for 1 week. During his 3-day hospital stay, his fever resolved, and his rash and edema improved.

During an outpatient follow-up visit with a pediatric dermatologist 2 weeks after discharge, the patient’s rash was still present and dermatographism was noted. In light of this, his parents were instructed to continue giving the cetirizine and hydroxyzine once daily for an additional 2 weeks and to return as needed.

‌

This case was adapted from: Cook JS, Angles A, Morley E. Urticaria and edema in a 2-year-old boy. J Fam Pract. 2021;70:353-355.

Photos courtesy of Jeffrey S. Cook, MD, FAAFP

Lab work was ordered and came back within normal range, except for an elevated white blood cell count (19,700/mm³; reference range, 4500-13,500/mm³). His mild systemic symptoms, skin lesions without blistering or necrosis, acral edema, and the absence of lymphadenopathy pointed to a diagnosis of urticaria multiforme.

Urticaria multiforme, also called acute annular urticaria or acute urticarial hypersensitivity syndrome, is a histamine-mediated hypersensitivity reaction characterized by transient annular, polycyclic, urticarial lesions with central ecchymosis. It typically manifests in children ages 4 months to 4 years and begins with small erythematous macules, papules, and plaques that progress to large blanchable wheals with dusky blue centers.^1-3 Lesions are usually located on the face, trunk, and extremities and are often pruritic (60%-94%).^1-3 The rash generally lasts 2 to 12 days.^1,3

Patients often report a preceding viral illness, otitis media, recent use of antibiotics, or recent immunizations. Patients also often have associated facial or acral edema (72%).¹ Children with significant edema of the feet may find walking difficult, which should not be confused with arthritis or arthralgias.

The diagnosis is made clinically and should not require a skin biopsy or extensive laboratory testing. When performed, laboratory studies—including CBC, erythrocyte sedimentation rate, C-reactive protein, and urinalysis—are routinely normal. The differential diagnosis in this case included erythema multiforme, Henoch-Schönlein purpura, serum sickness-like reaction, and urticarial vasculitis.^1,2,4

Treatment consists of discontinuing any offending agent (if suspected) and using systemic H1 or H2 antihistamines for symptom relief. Systemic steroids should only be given in refractory cases.

Our patient’s amoxicillin was discontinued, and he was started on a 14-day course of cetirizine 5 mg bid and hydroxyzine 10 mg at bedtime. He was also started on triamcinolone 0.1% cream to be applied twice daily for 1 week. During his 3-day hospital stay, his fever resolved, and his rash and edema improved.

During an outpatient follow-up visit with a pediatric dermatologist 2 weeks after discharge, the patient’s rash was still present and dermatographism was noted. In light of this, his parents were instructed to continue giving the cetirizine and hydroxyzine once daily for an additional 2 weeks and to return as needed.

‌

This case was adapted from: Cook JS, Angles A, Morley E. Urticaria and edema in a 2-year-old boy. J Fam Pract. 2021;70:353-355.

Photos courtesy of Jeffrey S. Cook, MD, FAAFP

Lab work was ordered and came back within normal range, except for an elevated white blood cell count (19,700/mm³; reference range, 4500-13,500/mm³). His mild systemic symptoms, skin lesions without blistering or necrosis, acral edema, and the absence of lymphadenopathy pointed to a diagnosis of urticaria multiforme.

Urticaria multiforme, also called acute annular urticaria or acute urticarial hypersensitivity syndrome, is a histamine-mediated hypersensitivity reaction characterized by transient annular, polycyclic, urticarial lesions with central ecchymosis. It typically manifests in children ages 4 months to 4 years and begins with small erythematous macules, papules, and plaques that progress to large blanchable wheals with dusky blue centers.^1-3 Lesions are usually located on the face, trunk, and extremities and are often pruritic (60%-94%).^1-3 The rash generally lasts 2 to 12 days.^1,3

Patients often report a preceding viral illness, otitis media, recent use of antibiotics, or recent immunizations. Patients also often have associated facial or acral edema (72%).¹ Children with significant edema of the feet may find walking difficult, which should not be confused with arthritis or arthralgias.

The diagnosis is made clinically and should not require a skin biopsy or extensive laboratory testing. When performed, laboratory studies—including CBC, erythrocyte sedimentation rate, C-reactive protein, and urinalysis—are routinely normal. The differential diagnosis in this case included erythema multiforme, Henoch-Schönlein purpura, serum sickness-like reaction, and urticarial vasculitis.^1,2,4

Treatment consists of discontinuing any offending agent (if suspected) and using systemic H1 or H2 antihistamines for symptom relief. Systemic steroids should only be given in refractory cases.

Our patient’s amoxicillin was discontinued, and he was started on a 14-day course of cetirizine 5 mg bid and hydroxyzine 10 mg at bedtime. He was also started on triamcinolone 0.1% cream to be applied twice daily for 1 week. During his 3-day hospital stay, his fever resolved, and his rash and edema improved.

During an outpatient follow-up visit with a pediatric dermatologist 2 weeks after discharge, the patient’s rash was still present and dermatographism was noted. In light of this, his parents were instructed to continue giving the cetirizine and hydroxyzine once daily for an additional 2 weeks and to return as needed.

‌

This case was adapted from: Cook JS, Angles A, Morley E. Urticaria and edema in a 2-year-old boy. J Fam Pract. 2021;70:353-355.

Photos courtesy of Jeffrey S. Cook, MD, FAAFP

Restless legs syndrome (RLS) is associated with an elevated risk of dementia among older adults, suggesting the disorder may be a risk factor for dementia or a very early noncognitive sign of dementia, researchers say.

In a large population-based cohort study, adults with RLS were significantly more likely to develop dementia over more than a decade than were their peers without RLS.

If confirmed in future studies, “regular check-ups for cognitive decline in older patients with RLS may facilitate earlier detection and intervention for those with dementia risk,” wrote investigators led by Eosu Kim, MD, PhD, with Yonsei University, Seoul, Republic of Korea.

The study was published online in Alzheimer’s Research and Therapy.
 

Sleep disorders and dementia

RLS is associated with poor sleep, depression/anxiety, poor diet, microvasculopathy, and hypoxia – all of which are known risk factors for dementia. However, the relationship between RLS and incident dementia has been unclear.

The researchers compared risk for all-cause dementia, Alzheimer’s disease (AD), and vascular dementia (VaD) among 2,501 adults with newly diagnosed RLS and 9,977 matched control persons participating in the Korean National Health Insurance Service–Elderly Cohort, a nationwide population-based cohort of adults aged 60 and older.

The mean age of the cohort was 73 years; most of the participants were women (65%). Among all 12,478 participants, 874 (7%) developed all-cause dementia during follow-up – 475 (54%) developed AD, and 194 (22%) developed VaD.

The incidence of all-cause dementia was significantly higher among the RLS group than among the control group (10.4% vs. 6.2%). Incidence rates of AD and VaD (5.6% and 2.6%, respectively) were also higher in the RLS group than in the control group (3.4% and 1.3%, respectively).

In Cox regression analysis, RLS was significantly associated with an increased risk of all-cause dementia (adjusted hazard ratio [aHR], 1.46; 95% confidence interval [CI], 1.24-1.72), AD (aHR 1.38; 95% CI, 1.11-1.72) and VaD (aHR, 1.81; 95% CI, 1.30-2.53).

The researchers noted that RLS may precede deterioration of cognitive function, leading to dementia, and they suggest that RLS could be regarded as a “newly identified” risk factor or prodromal sign of dementia.
 

Modifiable risk factor

Reached for comment, Thanh Dang-Vu, MD, PhD, professor and research chair in sleep, neuroimaging, and cognitive health at Concordia University in Montreal, said there is now “increasing literature that shows sleep as a modifiable risk factor for cognitive decline.

“Previous evidence indicates that both sleep apnea and insomnia disorder increase the risk for cognitive decline and possibly dementia. Here the study adds to this body of evidence linking sleep disorders to dementia, suggesting that RLS should also be considered as a sleep-related risk factor,” Dr. Dang-Vu told this news organization.

“More evidence is needed, though, as here, all diagnoses were based on national health insurance diagnostic codes, and it is likely there were missed diagnoses for RLS but also for other sleep disorders, as there was no systematic screening for them,” Dr. Dang-Vu cautioned.

Support for the study was provided by the Ministry of Health and Welfare, the Korean government, and Yonsei University. Dr. Kim and Dr. Dang-Vu reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Restless legs syndrome (RLS) is associated with an elevated risk of dementia among older adults, suggesting the disorder may be a risk factor for dementia or a very early noncognitive sign of dementia, researchers say.

In a large population-based cohort study, adults with RLS were significantly more likely to develop dementia over more than a decade than were their peers without RLS.

If confirmed in future studies, “regular check-ups for cognitive decline in older patients with RLS may facilitate earlier detection and intervention for those with dementia risk,” wrote investigators led by Eosu Kim, MD, PhD, with Yonsei University, Seoul, Republic of Korea.

The study was published online in Alzheimer’s Research and Therapy.
 

Sleep disorders and dementia

RLS is associated with poor sleep, depression/anxiety, poor diet, microvasculopathy, and hypoxia – all of which are known risk factors for dementia. However, the relationship between RLS and incident dementia has been unclear.

The researchers compared risk for all-cause dementia, Alzheimer’s disease (AD), and vascular dementia (VaD) among 2,501 adults with newly diagnosed RLS and 9,977 matched control persons participating in the Korean National Health Insurance Service–Elderly Cohort, a nationwide population-based cohort of adults aged 60 and older.

The mean age of the cohort was 73 years; most of the participants were women (65%). Among all 12,478 participants, 874 (7%) developed all-cause dementia during follow-up – 475 (54%) developed AD, and 194 (22%) developed VaD.

The incidence of all-cause dementia was significantly higher among the RLS group than among the control group (10.4% vs. 6.2%). Incidence rates of AD and VaD (5.6% and 2.6%, respectively) were also higher in the RLS group than in the control group (3.4% and 1.3%, respectively).

In Cox regression analysis, RLS was significantly associated with an increased risk of all-cause dementia (adjusted hazard ratio [aHR], 1.46; 95% confidence interval [CI], 1.24-1.72), AD (aHR 1.38; 95% CI, 1.11-1.72) and VaD (aHR, 1.81; 95% CI, 1.30-2.53).

The researchers noted that RLS may precede deterioration of cognitive function, leading to dementia, and they suggest that RLS could be regarded as a “newly identified” risk factor or prodromal sign of dementia.
 

Modifiable risk factor

Reached for comment, Thanh Dang-Vu, MD, PhD, professor and research chair in sleep, neuroimaging, and cognitive health at Concordia University in Montreal, said there is now “increasing literature that shows sleep as a modifiable risk factor for cognitive decline.

“Previous evidence indicates that both sleep apnea and insomnia disorder increase the risk for cognitive decline and possibly dementia. Here the study adds to this body of evidence linking sleep disorders to dementia, suggesting that RLS should also be considered as a sleep-related risk factor,” Dr. Dang-Vu told this news organization.

“More evidence is needed, though, as here, all diagnoses were based on national health insurance diagnostic codes, and it is likely there were missed diagnoses for RLS but also for other sleep disorders, as there was no systematic screening for them,” Dr. Dang-Vu cautioned.

Support for the study was provided by the Ministry of Health and Welfare, the Korean government, and Yonsei University. Dr. Kim and Dr. Dang-Vu reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Restless legs syndrome (RLS) is associated with an elevated risk of dementia among older adults, suggesting the disorder may be a risk factor for dementia or a very early noncognitive sign of dementia, researchers say.

In a large population-based cohort study, adults with RLS were significantly more likely to develop dementia over more than a decade than were their peers without RLS.

If confirmed in future studies, “regular check-ups for cognitive decline in older patients with RLS may facilitate earlier detection and intervention for those with dementia risk,” wrote investigators led by Eosu Kim, MD, PhD, with Yonsei University, Seoul, Republic of Korea.

The study was published online in Alzheimer’s Research and Therapy.
 

Sleep disorders and dementia

RLS is associated with poor sleep, depression/anxiety, poor diet, microvasculopathy, and hypoxia – all of which are known risk factors for dementia. However, the relationship between RLS and incident dementia has been unclear.

The researchers compared risk for all-cause dementia, Alzheimer’s disease (AD), and vascular dementia (VaD) among 2,501 adults with newly diagnosed RLS and 9,977 matched control persons participating in the Korean National Health Insurance Service–Elderly Cohort, a nationwide population-based cohort of adults aged 60 and older.

The mean age of the cohort was 73 years; most of the participants were women (65%). Among all 12,478 participants, 874 (7%) developed all-cause dementia during follow-up – 475 (54%) developed AD, and 194 (22%) developed VaD.

The incidence of all-cause dementia was significantly higher among the RLS group than among the control group (10.4% vs. 6.2%). Incidence rates of AD and VaD (5.6% and 2.6%, respectively) were also higher in the RLS group than in the control group (3.4% and 1.3%, respectively).

In Cox regression analysis, RLS was significantly associated with an increased risk of all-cause dementia (adjusted hazard ratio [aHR], 1.46; 95% confidence interval [CI], 1.24-1.72), AD (aHR 1.38; 95% CI, 1.11-1.72) and VaD (aHR, 1.81; 95% CI, 1.30-2.53).

The researchers noted that RLS may precede deterioration of cognitive function, leading to dementia, and they suggest that RLS could be regarded as a “newly identified” risk factor or prodromal sign of dementia.
 

Modifiable risk factor

Reached for comment, Thanh Dang-Vu, MD, PhD, professor and research chair in sleep, neuroimaging, and cognitive health at Concordia University in Montreal, said there is now “increasing literature that shows sleep as a modifiable risk factor for cognitive decline.

“Previous evidence indicates that both sleep apnea and insomnia disorder increase the risk for cognitive decline and possibly dementia. Here the study adds to this body of evidence linking sleep disorders to dementia, suggesting that RLS should also be considered as a sleep-related risk factor,” Dr. Dang-Vu told this news organization.

“More evidence is needed, though, as here, all diagnoses were based on national health insurance diagnostic codes, and it is likely there were missed diagnoses for RLS but also for other sleep disorders, as there was no systematic screening for them,” Dr. Dang-Vu cautioned.

Support for the study was provided by the Ministry of Health and Welfare, the Korean government, and Yonsei University. Dr. Kim and Dr. Dang-Vu reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

When a bacterial infection reaches the bloodstream, every second is critical. The person’s life is on the line. Yet blood tests to identify bacteria take hours to days. While waiting, doctors often prescribe broad-spectrum antibiotics in hopes of killing whatever bug may be at fault.

Someday soon, that wait time could shrink significantly, allowing health care providers to more quickly zero in on the best antibiotic for each infection – thanks to an innovation from Stanford (Calif.) University that identifies bacteria in seconds.

The cutting-edge method relies on old-school tech: an inkjet printer similar the kind you might have at home – except this one has been modified to print blood instead of ink.

This “bioprinter” spits out tiny drops of blood quickly – more than 1,000 per second. Shine a laser on the drops – using a light-based imaging technique called Raman spectroscopy – and the bacteria’s unique cellular “fingerprint” is revealed.

The very small sample size – each drop is two trillionths of a liter, or about a billion times smaller than a raindrop – make spotting bacteria easier. Smaller samples mean fewer cells, so lab techs can more swiftly separate the bacterial spectra from other components, like red blood cells and white blood cells.

To boost efficiency even more, the researchers added gold nanoparticles, which attach to the bacteria, serving like antennas to focus the light. Machine learning – a type of artificial intelligence – helps interpret the spectrum of light and identify which fingerprint goes with which bacteria.

“It kind of wound up being this really interesting historical period where we could put the pieces together from different technologies, including nanophotonics, printing, and artificial intelligence, to help accelerate identification of bacteria in these complex samples,” says study author Jennifer Dionne, PhD, associate professor of materials science and engineering at Stanford.

Compare that to blood culture testing in hospitals, where it takes days for bacterial cells to grow and multiply inside a large machine that looks like a refrigerator. For some bacteria, like the kinds that cause tuberculosis, cultures take weeks.

Then further testing is needed to identify which antibiotics will quell the infection. The new technology from Stanford could accelerate this process, too.

“The promise of our technique is that you don’t need to have a culture of cells to put the antibiotic on top,” says Dr. Dionne. “What we’re finding is that from the Raman scattering, we can use that to identify – even without incubating with antibiotics – which drug the bacteria would respond to, and that’s really exciting.”

If patients can receive the antibiotic best suited for their infection, they will likely have better outcomes.

“Blood cultures can typically take 48-72 hours to come back, and then you base your clinical decisions and adjusting antibiotics based on those blood cultures,” says Richard Watkins, MD, an infectious disease physician and professor of medicine at the Northeastern Ohio Universities, Rootstown. Dr. Watkins was not involved in the study.

“Sometimes, despite your best guess, you’re wrong,” Dr. Watkins says, “and obviously, the patient could have an adverse outcome. So, if you can diagnose the pathogen sooner, that is ideal. Whatever technology enables clinicians to do that is definitely progress and a step forward.”

On a global scale, this technology could help reduce the overuse of broad-spectrum antibiotics, which contributes to antimicrobial resistance, an emerging health threat, says Dr. Dionne.

The team is working to develop the technology further into an instrument the size of a shoebox and, with further testing, commercialize the product. That could take a few years.

This technology has potential beyond bloodstream infections, too. It could be used to identify bacteria in other fluids, such as in wastewater or contaminated food.

A version of this article originally appeared on WebMD.com.

When a bacterial infection reaches the bloodstream, every second is critical. The person’s life is on the line. Yet blood tests to identify bacteria take hours to days. While waiting, doctors often prescribe broad-spectrum antibiotics in hopes of killing whatever bug may be at fault.

Someday soon, that wait time could shrink significantly, allowing health care providers to more quickly zero in on the best antibiotic for each infection – thanks to an innovation from Stanford (Calif.) University that identifies bacteria in seconds.

The cutting-edge method relies on old-school tech: an inkjet printer similar the kind you might have at home – except this one has been modified to print blood instead of ink.

This “bioprinter” spits out tiny drops of blood quickly – more than 1,000 per second. Shine a laser on the drops – using a light-based imaging technique called Raman spectroscopy – and the bacteria’s unique cellular “fingerprint” is revealed.

The very small sample size – each drop is two trillionths of a liter, or about a billion times smaller than a raindrop – make spotting bacteria easier. Smaller samples mean fewer cells, so lab techs can more swiftly separate the bacterial spectra from other components, like red blood cells and white blood cells.

To boost efficiency even more, the researchers added gold nanoparticles, which attach to the bacteria, serving like antennas to focus the light. Machine learning – a type of artificial intelligence – helps interpret the spectrum of light and identify which fingerprint goes with which bacteria.

“It kind of wound up being this really interesting historical period where we could put the pieces together from different technologies, including nanophotonics, printing, and artificial intelligence, to help accelerate identification of bacteria in these complex samples,” says study author Jennifer Dionne, PhD, associate professor of materials science and engineering at Stanford.

Compare that to blood culture testing in hospitals, where it takes days for bacterial cells to grow and multiply inside a large machine that looks like a refrigerator. For some bacteria, like the kinds that cause tuberculosis, cultures take weeks.

Then further testing is needed to identify which antibiotics will quell the infection. The new technology from Stanford could accelerate this process, too.

“The promise of our technique is that you don’t need to have a culture of cells to put the antibiotic on top,” says Dr. Dionne. “What we’re finding is that from the Raman scattering, we can use that to identify – even without incubating with antibiotics – which drug the bacteria would respond to, and that’s really exciting.”

If patients can receive the antibiotic best suited for their infection, they will likely have better outcomes.

“Blood cultures can typically take 48-72 hours to come back, and then you base your clinical decisions and adjusting antibiotics based on those blood cultures,” says Richard Watkins, MD, an infectious disease physician and professor of medicine at the Northeastern Ohio Universities, Rootstown. Dr. Watkins was not involved in the study.

“Sometimes, despite your best guess, you’re wrong,” Dr. Watkins says, “and obviously, the patient could have an adverse outcome. So, if you can diagnose the pathogen sooner, that is ideal. Whatever technology enables clinicians to do that is definitely progress and a step forward.”

On a global scale, this technology could help reduce the overuse of broad-spectrum antibiotics, which contributes to antimicrobial resistance, an emerging health threat, says Dr. Dionne.

The team is working to develop the technology further into an instrument the size of a shoebox and, with further testing, commercialize the product. That could take a few years.

This technology has potential beyond bloodstream infections, too. It could be used to identify bacteria in other fluids, such as in wastewater or contaminated food.

A version of this article originally appeared on WebMD.com.

When a bacterial infection reaches the bloodstream, every second is critical. The person’s life is on the line. Yet blood tests to identify bacteria take hours to days. While waiting, doctors often prescribe broad-spectrum antibiotics in hopes of killing whatever bug may be at fault.

Someday soon, that wait time could shrink significantly, allowing health care providers to more quickly zero in on the best antibiotic for each infection – thanks to an innovation from Stanford (Calif.) University that identifies bacteria in seconds.

The cutting-edge method relies on old-school tech: an inkjet printer similar the kind you might have at home – except this one has been modified to print blood instead of ink.

This “bioprinter” spits out tiny drops of blood quickly – more than 1,000 per second. Shine a laser on the drops – using a light-based imaging technique called Raman spectroscopy – and the bacteria’s unique cellular “fingerprint” is revealed.

The very small sample size – each drop is two trillionths of a liter, or about a billion times smaller than a raindrop – make spotting bacteria easier. Smaller samples mean fewer cells, so lab techs can more swiftly separate the bacterial spectra from other components, like red blood cells and white blood cells.

To boost efficiency even more, the researchers added gold nanoparticles, which attach to the bacteria, serving like antennas to focus the light. Machine learning – a type of artificial intelligence – helps interpret the spectrum of light and identify which fingerprint goes with which bacteria.

“It kind of wound up being this really interesting historical period where we could put the pieces together from different technologies, including nanophotonics, printing, and artificial intelligence, to help accelerate identification of bacteria in these complex samples,” says study author Jennifer Dionne, PhD, associate professor of materials science and engineering at Stanford.

Compare that to blood culture testing in hospitals, where it takes days for bacterial cells to grow and multiply inside a large machine that looks like a refrigerator. For some bacteria, like the kinds that cause tuberculosis, cultures take weeks.

Then further testing is needed to identify which antibiotics will quell the infection. The new technology from Stanford could accelerate this process, too.

“The promise of our technique is that you don’t need to have a culture of cells to put the antibiotic on top,” says Dr. Dionne. “What we’re finding is that from the Raman scattering, we can use that to identify – even without incubating with antibiotics – which drug the bacteria would respond to, and that’s really exciting.”

If patients can receive the antibiotic best suited for their infection, they will likely have better outcomes.

“Blood cultures can typically take 48-72 hours to come back, and then you base your clinical decisions and adjusting antibiotics based on those blood cultures,” says Richard Watkins, MD, an infectious disease physician and professor of medicine at the Northeastern Ohio Universities, Rootstown. Dr. Watkins was not involved in the study.

“Sometimes, despite your best guess, you’re wrong,” Dr. Watkins says, “and obviously, the patient could have an adverse outcome. So, if you can diagnose the pathogen sooner, that is ideal. Whatever technology enables clinicians to do that is definitely progress and a step forward.”

On a global scale, this technology could help reduce the overuse of broad-spectrum antibiotics, which contributes to antimicrobial resistance, an emerging health threat, says Dr. Dionne.

The team is working to develop the technology further into an instrument the size of a shoebox and, with further testing, commercialize the product. That could take a few years.

This technology has potential beyond bloodstream infections, too. It could be used to identify bacteria in other fluids, such as in wastewater or contaminated food.

A version of this article originally appeared on WebMD.com.

This patient was given a diagnosis of bullous pemphigoid. Although there were a number of clues that pointed to this diagnosis, confirming that this was the case required 2 biopsies and a blood draw. (More on this in a bit.)

Although rare and potentially lethal, bullous pemphigoid is the most common autoimmune blistering disease in the elderly. Patients present with tense bullae over limited or widespread areas of the skin. The pathogenesis includes development of autoimmune antibodies that target important proteins (BP180 and BP230) that bind basal epidermal keratinocytes to the dermis. When weakened by inflammation at these sites, the skin delaminates at the dermal-epidermal junction, while the cells of the epidermis continue to bind to each other. This leads to itching, hive-like wheals, and tense fluid-filled bullae.

The differential diagnosis of an acute or semi-acute bullous disease includes bullous pemphigoid, IgA pemphigoid, linear IgA bullous dermatosis, epidermolysis bullosa acquisita, and Senear-Usher syndrome. In this case, the large tense bullae suggested bullous pemphigoid over the other diagnoses.

Initial diagnosis requires 2 biopsies be performed: One at the edge of a bulla for a standard pathologic exam to identify the skin level at which the bulla is forming, and another biopsy of skin near the site of inflammation (5-10 mm away) to be sent for direct immunofluorescence (DIF) in Michel’s medium or Zeus medium. In bullous pemphigoid, the separation is at the dermal-epidermal junction, and IgG and C3 are found in the DIF in the same location. There are a couple ways to differentiate this disorder from epidermolysis bullosa acquisita—a similar blistering disorder in which autoantibodies attack collagen at the dermal-epidermal junction. A common approach is to send a patient’s serum for indirect immunofluorescence. This is done because it is impossible to distinguish between the 2 clinically.

While bullous pemphigoid has historically been treated with high-dose prednisone, it is more common now to treat with whole-body topical clobetasol and oral doxycycline 100 mg twice a day to avoid the adverse effects of the prednisone. Other immunosuppressive options, such as mycophenolate mofetil and cyclosporine, can provide the potency of prednisone with a more favorable long-term safety profile. Rituximab infusions are another very powerful and durable option in refractory or severe cases.¹

This patient was treated with topical clobetasol and doxycycline 100 mg twice a day, but he had incomplete clearance after 2 to 3 weeks. At that point, mycophenolate mofetil was added to the regimen and was titrated up to 1000 mg twice daily. When clearance occurred, the clobetasol was discontinued and the mycophenolate mofetil was titrated down to 250 mg/d; the patient continues to maintain clearance at this dose. He continues on doxycycline 100 mg bid.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

This patient was given a diagnosis of bullous pemphigoid. Although there were a number of clues that pointed to this diagnosis, confirming that this was the case required 2 biopsies and a blood draw. (More on this in a bit.)

Although rare and potentially lethal, bullous pemphigoid is the most common autoimmune blistering disease in the elderly. Patients present with tense bullae over limited or widespread areas of the skin. The pathogenesis includes development of autoimmune antibodies that target important proteins (BP180 and BP230) that bind basal epidermal keratinocytes to the dermis. When weakened by inflammation at these sites, the skin delaminates at the dermal-epidermal junction, while the cells of the epidermis continue to bind to each other. This leads to itching, hive-like wheals, and tense fluid-filled bullae.

The differential diagnosis of an acute or semi-acute bullous disease includes bullous pemphigoid, IgA pemphigoid, linear IgA bullous dermatosis, epidermolysis bullosa acquisita, and Senear-Usher syndrome. In this case, the large tense bullae suggested bullous pemphigoid over the other diagnoses.

Initial diagnosis requires 2 biopsies be performed: One at the edge of a bulla for a standard pathologic exam to identify the skin level at which the bulla is forming, and another biopsy of skin near the site of inflammation (5-10 mm away) to be sent for direct immunofluorescence (DIF) in Michel’s medium or Zeus medium. In bullous pemphigoid, the separation is at the dermal-epidermal junction, and IgG and C3 are found in the DIF in the same location. There are a couple ways to differentiate this disorder from epidermolysis bullosa acquisita—a similar blistering disorder in which autoantibodies attack collagen at the dermal-epidermal junction. A common approach is to send a patient’s serum for indirect immunofluorescence. This is done because it is impossible to distinguish between the 2 clinically.

While bullous pemphigoid has historically been treated with high-dose prednisone, it is more common now to treat with whole-body topical clobetasol and oral doxycycline 100 mg twice a day to avoid the adverse effects of the prednisone. Other immunosuppressive options, such as mycophenolate mofetil and cyclosporine, can provide the potency of prednisone with a more favorable long-term safety profile. Rituximab infusions are another very powerful and durable option in refractory or severe cases.¹

This patient was treated with topical clobetasol and doxycycline 100 mg twice a day, but he had incomplete clearance after 2 to 3 weeks. At that point, mycophenolate mofetil was added to the regimen and was titrated up to 1000 mg twice daily. When clearance occurred, the clobetasol was discontinued and the mycophenolate mofetil was titrated down to 250 mg/d; the patient continues to maintain clearance at this dose. He continues on doxycycline 100 mg bid.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

This patient was given a diagnosis of bullous pemphigoid. Although there were a number of clues that pointed to this diagnosis, confirming that this was the case required 2 biopsies and a blood draw. (More on this in a bit.)

Although rare and potentially lethal, bullous pemphigoid is the most common autoimmune blistering disease in the elderly. Patients present with tense bullae over limited or widespread areas of the skin. The pathogenesis includes development of autoimmune antibodies that target important proteins (BP180 and BP230) that bind basal epidermal keratinocytes to the dermis. When weakened by inflammation at these sites, the skin delaminates at the dermal-epidermal junction, while the cells of the epidermis continue to bind to each other. This leads to itching, hive-like wheals, and tense fluid-filled bullae.

The differential diagnosis of an acute or semi-acute bullous disease includes bullous pemphigoid, IgA pemphigoid, linear IgA bullous dermatosis, epidermolysis bullosa acquisita, and Senear-Usher syndrome. In this case, the large tense bullae suggested bullous pemphigoid over the other diagnoses.

Initial diagnosis requires 2 biopsies be performed: One at the edge of a bulla for a standard pathologic exam to identify the skin level at which the bulla is forming, and another biopsy of skin near the site of inflammation (5-10 mm away) to be sent for direct immunofluorescence (DIF) in Michel’s medium or Zeus medium. In bullous pemphigoid, the separation is at the dermal-epidermal junction, and IgG and C3 are found in the DIF in the same location. There are a couple ways to differentiate this disorder from epidermolysis bullosa acquisita—a similar blistering disorder in which autoantibodies attack collagen at the dermal-epidermal junction. A common approach is to send a patient’s serum for indirect immunofluorescence. This is done because it is impossible to distinguish between the 2 clinically.

While bullous pemphigoid has historically been treated with high-dose prednisone, it is more common now to treat with whole-body topical clobetasol and oral doxycycline 100 mg twice a day to avoid the adverse effects of the prednisone. Other immunosuppressive options, such as mycophenolate mofetil and cyclosporine, can provide the potency of prednisone with a more favorable long-term safety profile. Rituximab infusions are another very powerful and durable option in refractory or severe cases.¹

This patient was treated with topical clobetasol and doxycycline 100 mg twice a day, but he had incomplete clearance after 2 to 3 weeks. At that point, mycophenolate mofetil was added to the regimen and was titrated up to 1000 mg twice daily. When clearance occurred, the clobetasol was discontinued and the mycophenolate mofetil was titrated down to 250 mg/d; the patient continues to maintain clearance at this dose. He continues on doxycycline 100 mg bid.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.