From The Johns Hopkins Hospital, Baltimore, MD.

The project described was supported by grant # 1C1CMS331053-01-00 from the U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services. The content of this paper is solely the responsibility of the authors and does not necessarily represent the official views of the U.S. Department of Health and Human Services or any of its agencies. The research presented was conducted by the awardee. Findings may or may not be consistent with or confirmed by the findings of the independent evaluation contractor.

Abstract

• Background: Medication management is becoming more complex, with new medications entering the market, drug prices increasing, and patients transferring into and out of the hospital. Transitions of care services are being implemented to prevent readmissions and increase patient satisfaction. Pharmacists play a key role by expanding clinical services provided to patients around medication management.
• Objective: To describe a pharmacy transitions of care model at a large academic teaching hospital and lessons learned during implementation.
• Methods: A pharmacy bundle of services was initially developed in a medical patient population and included medication reconciliation, patient education targeting high-risk medications, post-discharge follow-up phone calls, and bedside discharge prescription delivery. This bundle was expanded to other patient populations through the use of residency-trained pharmacists, pharmacy residents, pharmacy students, and certified pharmacy technicians.
• Results: Challenges were faced when implementing our transitions of care services, including expanding care coordination team coverage with existing resources, training pharmacy staff in new roles, determining the needs of patients cared for by teams we had not previously been integrated into, and creating our discharge prescription delivery program. During this process, we learned to rethink the role of pharmacists on our team, value the support within our institution to create change in order to improve patient care, and continuously evaluate this process.
• Conclusion: We are at an opportune time to expand the scope of the inpatient pharmacist to provide advanced medication-related services to patients. Residency training is creating individuals who will thrive in these new models.

Medication management around the acute care inpatient stay is a challenging but crucial task to ensure patient safety and desired clinical outcomes. The first step in successful medication management is to understand the patient’s medication regimen in the home environment. Patients may take medications differently than prescribed; skip medication doses intentionally to make a supply last longer; use over-the-counter medications, herbal supplements, or someone else’s medication based on the recommendation of family or friends; or discontinue medications based on side effects or media influence. Over the course of the inpatient stay, medication management involves adjusting doses based on changes in organ function, detecting side effects and potential drug interactions, and monitoring clinical outcomes to ensure appropriate drug therapy is being prescribed. As the patient approaches discharge, ensuring the patient understands the indications for his/her medications, has self-monitoring techniques to recognize efficacy or adverse effects, and has access to discharge medications is important. Lastly, long-term medication management includes patient access to pharmaceutical expertise over time. Pharmacists’ involvement in medication therapy management services and patient-centered medical homes is key to ensuring safe and effective medication use over time.

In 2009, the Johns Hopkins Health System Readmission Prevention Task Force developed strategies to reduce preventable readmissions and improve transitions of care. In 2011, a new multidisciplinary approach to patient care was implemented at the Johns Hopkins Hospital (JHH) to optimize care coordination and improve acute care management. Using this approach, care coordination teams composed of physicians, nurses, pharmacists, nurse case managers, social workers, physical/occupational therapists, nutritionists, and home care coordinators meet on a daily basis to discuss the inpatient and discharge care needs of patients in order to improve care transitions and reduce preventable readmissions. In 2012, JHH was awarded a 3-year innovation grant from the Centers for Medicaid & Medicare Services (CMS) that would assist with expansion of these care coordination teams to every unit of the hospital. Prior to implementation of the care coordination model at JHH in 2011, there were 3 pharmacists who consistently rounded on 3 inpatient medicine teams (one pharmacist also had operational responsibilities). Pharmacists were deemed by the task force to be key providers of medication management and, thus, essential members of the care coordination team. Due to an inability to hire a new pharmacist for every care coordination team, the department of pharmacy needed to determine how to provide consistent pharmacist coverage utilizing current resources. This report describes the challenges faced and lessons learned by our adult inpatient pharmacy division when implementing a pharmacy bundle of services to improve care transitions for an adult patient population.

Setting

JHH is an 1192-bed academic teaching hospital located in Baltimore, Maryland. At JHH, the department of pharmacy has 4 inpatient divisions that service the medication needs of different patient populations: medicine, critical care/surgery, oncology, and pediatrics. The adultinpatient pharmacy division covers medicine units in addition to obstetrics, neurology, and surgery units. It is responsible for 486 inpatient beds on 22 units and was the first division to provide the pharmacy bundle of services described below. Currently, 11 rounding and 5 operational pharmacists provide care coordination and order verification support, respectively, for the division during day shift.

Program Overview

Rounding pharmacists on care coordination teams address acute care medication issues and provide a bundle of services that includes targeted patient education, medication reconciliation, post-discharge follow-up phone calls, and discharge prescription planning. The full details of these services have been described [1]. Briefly, patients newly initiated on medications deemed ”high-risk” (eg, anticoagulation, insulin, metered dose inhalers, dual antiplatelets) receive education by a member of the pharmacy team (ie, pharmacist, pharmacy resident, or pharmacy student) prior to discharge. Those patients who receive education are offered a post-discharge follow-up phone call to assess for any questions or issues. Patients who accept this service are contacted 48 to 72 hours post-discharge. Specific patient populations (eg, patients with congestive heart failure, diabetes) are also targeted for completion of medication reconciliation. If patients are being discharged with prescriptions, they are offered our “Meds for Home” service. Patients who accept this service have their prescriptions filled at one of our outpatient pharmacies and delivered to the unit prior to discharge. Highly trained certified pharmacy technicians, called “Meds for Home” coordinators (MHCs; previously known as transitions pharmacist extenders), facilitate this process.

Challenges Faced

Care Coordination Team Coverage

One challenge to implementation of the pharmacy bundle of services was providing consistent team coverage with adequately trained pharmacists. It was not feasible to hire a pharmacist to cover each of the care coordination teams. To address gaps in coverage, we initially utilized postgraduate year 1 and 2 (PGY1 and 2) pharmacy residents on an internal medicine rotation to cover care coordination teams without a rounding pharmacist. However, this method proved unreliable as a pharmacy resident was not scheduled for an internal medicine rotation each month. In the beginning, our division had 3 rounding and 9 operational pharmacists during day shift. To provide sufficient clinical coverage while still adequately addressing order verification needs, a major restructuring of our pharmacy model was necessary. We increased the bed-to-pharmacist ratio for order verification, which allowed the number of operational pharmacists to decrease from 9 to 5. Those 4 remaining pharmacists were now available to serve as rounding pharmacists. Along with hiring 2 additional rounding pharmacists with funding from the CMS innovation grant, we were able to increase the number of care coordination teams consistently covered from 3 to 9.

Although we expanded pharmacist coverage of care coordination teams, time constraints prevented all patients who met criteria for patient education or medication reconciliation to have these services completed in a timely manner or at all by a pharmacist. Our rounding pharmacists’ responsibilities also included participation in high-level activities such as order set reviews for a new provider order entry system, ambulatory clinic time, stewardship activities, and quality improvement projects. In order to increase our scope, we utilized pharmacy technicians, students, and residents to assist with completing these tasks. All pharmacy students and residents on rotation within our division participated in a daily huddle Monday through Friday. Rounding pharmacists whose unit had patient education needs that could not be met by that pharmacist submitted requests by a set time. Those patient education tasks were then divided amongst the pharmacy learners at the huddle for completion. Prior to being allowed to independently counsel patients, pharmacy learners’ patient education skills were evaluated by preceptors. To facilitate timely completion of medication histories, technicians were hired. These medication history technicians are available Monday through Friday to complete medication histories for patients admitted to specific medicine units, ideally within 24 hours of admission. Rounding pharmacists are notified of completion of medication histories via our electronic medical record and reconcile that list with the patient’s inpatient medication list. Any clinically relevant discrepancies are communicated to providers. Pharmacy learners may also collect medication histories.

Training Rounding Pharmacists

Another challenge we faced was providing adequate training for operational pharmacists transitioning to a rounding position. Residency training is crucial in providing the level of skill necessary to identify complex drug therapy problems, adjust treatment regimens, and create plans where limited data exist to drive drug therapy recommendations [2,3]. Rotations during the final year of pharmacy school provide exposure to interacting with patients and providers. Completion of PGY1 residency training allows a pharmacist to practice as a generalist with a broad range of experiences provided during the year to identify medication-related problems. PGY2 residency training allows the pharmacist to spend a concentrated year in the chosen area of expertise and gain a deeper knowledge of medication use in a specific patient population or area of practice [2]. After 2 years of clinical residency training, pharmacists have the skills to interact with patients and multidisciplinary teams to optimize medication regimens, provide medication education, and measure the value they bring to the health care of patients.

Some of the operational pharmacists who were transitioning to the rounding pharmacist role had no training beyond pharmacy school or had only completed a PGY1 pharmacy residency. Initially, training for this new role lasted only a few days and consisted of orientation to the unit and observation of care coordination rounds. We learned that this brief amount of training was insufficient, even for those with PGY1 pharmacy residency training. In order to ensure that these rounding pharmacists could successfully provide the bundle of services and meet the high clinical demands of the inpatient service, we developed a comprehensive training program. Those interested in transitioning from an operational to a rounding pharmacist role must now complete a 6-week training program. The first 2 weeks consists of improving patient education and medication history skills. The remaining 4 weeks are spent honing clinical rounding skills. Rounding pharmacists-in-training also receive a formal review of their performance utilizing an evaluation form developed by the American Society of Health-System Pharmacists (ASHP) for pharmacy residents.

Establishing a Pharmacy Bundle and the Role of a Rounding Pharmacist on New Units

Some of the units implementing care coordination teams, such as neurology, did not previously have a pharmacist rounding on those units. Furthermore, these units had a high patient census (eg, 60 patients), which made it difficult for one pharmacist to clinically evaluate every patient. Multiple specialty teams also admitted patients to a single unit, which made it challenging for the pharmacist to develop strong working relationships with providers. As such, rounding pharmacists deployed to those units had difficulty establishing their role on the team, especially for those pharmacists without or with only 1 year of postgraduate training. To address this issue, a PGY2-trained pharmacist rounded on the unit to assess which areas/teams had the greatest need for a pharmacist. Completing this needs assessment on these units allowed for the rounding pharmacist to more effectively use his/her time. It also allowed for a smoother transition from operational to rounding pharmacist by removing the burden of establishing a brand new role and identifying necessary tasks to be completed throughout the day.

We also discovered on these new care coordination units that our patient criteria for education and medication reconciliation were not universal. We developed and initiated our pharmacy bundle of services in a medical patient population. As we expanded these services to other patient care areas, the targeted list of medications/conditions changed. For example, surgical patients had a greater need for education around opioid therapy and complex bowel regimens while neurology patients needed education regarding antiepileptic regimens. Similarly, patients requiring medication reconciliation also changed. Nurses were performing medication reconciliation for patients with elective surgeries and had a system that worked for that population. Therefore, we did not need to focus efforts for this population around medication reconciliation and could shift our focus more towards medication education.

Optimizing the Delivery of Discharge Prescriptions

The Meds for Home workflow has been updated multiple times since implementation. These changes resulted from early and frequent meetings with nurses, case managers, providers, and the pharmacy team. The Meds for Home service uses an outpatient pharmacy located within the hospital that has high prescription volumes at baseline to fill discharge prescriptions. Due to the volume of out-patient prescriptions and unexpected discharges, delays in prescription delivery occurred. To improve efficiency, a separate workflow and space were designated for filling Meds for Home prescriptions. Initially, MHCs were visiting floors to pick-up and deliver prescriptions at set times (ie, 10 am, 2 pm, and 5 pm). Instead of using set pick-up and delivery times, the Meds for Home service now uses a rolling 2-hour turnaround time during service hours. Additionally, providers, case managers, and units were educated to provide discharge prescriptions, especially those requiring prior authorization, as early as possible to expedite service. By identifying these issues early in the process, we were able to develop a different strategy that worked for the units, providers, and pharmacy.

Lessons Learned

The time of transition from one level of care to another is a vulnerable time for patients, as it is a time when medication-related problems often arise. In an elderly patient population, one study demonstrated that contributing factors for medication discrepancies following hospital discharge included unintended nonadherence and inadequate discharge instructions, and patients experiencing a medication discrepancy were at a significantly higher risk of readmission [4]. Hospital readmissions have also been linked to a lack of adequate follow-up in the outpatient setting [5]. Pharmacists should become more involved in preventing medication-related problems during the times of transition by performing activities such as medication reconciliation, patient education, and assessment of patient outcomes post-discharge [6,7]. Studies have demonstrated that pharmacists are able to reduce medication-related adverse events during and after hospitalization by completing these activities [8–10]. Residency-trained pharmacists are well-equipped to provide these services and are needed to create new processes and models to meet the ever changing demands of health care payers and accrediting bodies. ASHP recommends pharmacists entering into careers in health systems be at least PGY1-trained while the American College of Clinical Pharmacy (ACCP) envisions all pharmacists involved in direct patient care complete residency training [11,12]. Health systems will continue to be challenged with transforming pharmacy models to allow for this influx of highly trained individuals in a time of budget constraints. Below, we describe the lessons we learned while implementing our pharmacy bundle of services and think are essential for other institutions to consider when initiating their own services.

Rethink the Role of the Pharmacist

As health systems acquire smaller hospitals, the role of the pharmacist may need to be redefined and reinvented. The responsibilities of a pharmacist in a large academic hospital may be different than those of a pharmacist with the same skill set in a community hospital. However, despite the difference in practice setting, the same core pharmacy services around medication use can still be deployed. Participation in transitions of care activities is a relatively new concept for many pharmacists as residency training programs traditionally focused on caring for patients within a defined setting such as the intensive care unit or ambulatory care. The pharmacy profession should define the role of the clinical pharmacist in order to make the incorporation of transitions of care responsibilities into job expectations easier for all. The ACCP outlines this need and sets forth recommendations for clinical pharmacists’ responsibilities within the health care team to include assessing patients and medication regimens, developing and implementing medication-related therapy plans, and evaluating clinical outcomes [13]. Pharmacy leadership organizations, including ASHP and ACCP, offer resources providing the vision of pharmacy practice and expectations for which institutions should be reaching. Pharmacy departments should use these resources to complete gap analyses of current processes and those envisioned for the future to help guide efforts for change at their own institutions.

Obtain Support Within Your Institution

Gaining support from hospital leadership for advancing pharmacists’ involvement in patient care is instrumental. Without leadership support at both the institutional and department of pharmacy levels, pharmacists with advanced training may be hindered from practicing at the top of their license. Furthermore, support by leadership of pharmacy residency programs and experiential student learning sites at the institution is also important. Pharmacy residents and students became indispensable in our model and allowed us to expand our reach to more patients. We used residents to cover additional teams that were previously uncovered by a rounding pharmacist and, along with students, provide medication reconciliation, patient education, and follow-up phone calls to more patients. Requiring participation in the pharmacy bundle of services for rotations also allowed us to train these individuals about the value of transitions of care and see the challenges patients face in gaining access to medications. In a survey of academic medical center executives, pharmacy directors, and pharmacists at 8 institutions, residents were noted to add value to the institution through decreasing drug-related errors and drug costs, expansion of clinical services, and enhancing opportunities for research [14].

Support from other disciplines is also essential. Collaborating with other disciplines should occur prior to, during, and beyond implementation. We collaborated with providers, nurses, case managers, social workers and many other disciplines during all phases of the process. Being inclusive during the planning process allowed everyone to understand each other’s role and to provide input on how we could work together to best utilize everyone’s resources. This multidisciplinary approach to developing pharmacy services also allowed an opportunity to collaborate on research and evaluate our processes with other disciplines.

Tracking interventions will demonstrate the value of pharmacists, technicians, and other pharmacy team members participating in these advanced roles. This information will be useful when justifying the practice model to hospital leadership and for recruiting new pharmacists, residents, and technicians to the institution. Additionally, defining both outcome (eg, 30-day readmission rates, HCAHPS scores) and process (eg, number of patient education sessions performed, number of medication discrepancies reconciled) measures upfront is important in order for those involved to understand how their work will be assessed. These data will be useful in determining whether the intervention is making an impact early on and allow for restructuring of the process if not.

Create Depth in Your Team While Engaging Current Resources

We spent a significant amount of time planning the implementation of our pharmacy bundle of services, collaborating with other disciplines, and training our pharmacy team members. We hired highly trained and competent people into new positions and ensured every-one clearly understood their responsibilities. This was a critical step in order to ensure we were providing optimal care to our patients and integrating leaders into our team. We also utilized our current workforce to fill new clinical rounding pharmacist or technician roles. For those pharmacists who had not completed a residency, we required the pharmacists to complete a compact training program similar to that required of our residents [1]. This training ensured that important services were being performed adequately by each rounding pharmacist. Similarly, technicians transitioning from a primarily medication dispensing role to a MHC or medication history role received extensive training to assist with developing their new skill set.

Creating relationships with an outpatient pharmacy is essential to ensure patients are discharged from the hospital on medications they can afford long-term. We are fortunate to have 5 outpatient pharmacies on the JHH campus that are under the Johns Hopkins Health System umbrella, which made collaboration between the inpatient and outpatient teams seamless. However, many hospitals may not be directly affiliated with an outpatient pharmacy with which to collaborate or may contract with a retail chain pharmacy. In the latter case, inpatient and outpatient pharmacies must work together to define roles around transitions of care and how to best serve the patient in a collaborative manner. If no onsite outpatient pharmacy exists, dedicated resources should be acquired to serve as a liaison between the inpatient team and the outpatient pharmacy. These resources may work through issues such as formulary preferences, prior authorization requests, and connecting the patient to the medication either through bedside delivery or filling at the patient’s community pharmacy. Community pharmacies recognize the cost benefit they could gain through 340B pricing and specialty drug dispensing when working in collaboration with healthcare systems. However, health systems must be aware that collaborating with outpatient pharmacy partnerships will create further challenges as providers ensure patient preference for use of a particular pharmacy is honored and cost-sharing is incorporated into models.

Continuously Reevaluate Your Services

As implementation of our pharmacy bundle of services began, meeting early and often was essential to identify issues and adjust our workflow to resolve those issues quickly. When the inpatient component of the pharmacy bundle of services was first implemented, rounding pharmacists and pharmacy leadership initially met on a weekly basis to provide feedback on the practice model and develop resolutions for any issues. However, it is important to also include other disciplines in the evaluation process. For the Meds for Home program, pharmacy leadership not only met with MHCs but also with providers, nurses, case managers, and social workers for feedback on how to improve the service. Although the workflow of our pharmacy bundle of services are more established, evaluations still occur albeit less frequently.

Conclusion

Pharmacists’ involvement in transitions of care should become part of the daily responsibility. Health systems should understand how efforts to expand pharmacists’ interventions align with overall hospital goals. Many hospitals may already have programs in place to help with transitions of care. Pharmacists can help expand current efforts through increased visibility to physicians and patients as well as collaboration with outpatient pharmacies to ensure medications are effective and affordable for patients long-term.

Note: The project described was supported by grant no. 1C1CMS331053-01-00 from the U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services. The content of this paper is solely the responsibility of the authors and does not necessarily represent the official views of the U.S. Department of Health and Human Services or any of its agencies. The research presented was conducted by the awardee. Findings may or may not be consistent with or confirmed by the findings of the independent evaluation contractor.

Corresponding author: Vi Gilmore, PharmD, BCPS, Clinical Pharmacy Specialist, Internal Medicine, The Johns Hopkins Hospital, 600 N. Wolfe Street, Carnegie 180, Baltimore, MD 21287, [email protected].

Financial disclosures: None.

From The Johns Hopkins Hospital, Baltimore, MD.

The project described was supported by grant # 1C1CMS331053-01-00 from the U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services. The content of this paper is solely the responsibility of the authors and does not necessarily represent the official views of the U.S. Department of Health and Human Services or any of its agencies. The research presented was conducted by the awardee. Findings may or may not be consistent with or confirmed by the findings of the independent evaluation contractor.

Abstract

• Background: Medication management is becoming more complex, with new medications entering the market, drug prices increasing, and patients transferring into and out of the hospital. Transitions of care services are being implemented to prevent readmissions and increase patient satisfaction. Pharmacists play a key role by expanding clinical services provided to patients around medication management.
• Objective: To describe a pharmacy transitions of care model at a large academic teaching hospital and lessons learned during implementation.
• Methods: A pharmacy bundle of services was initially developed in a medical patient population and included medication reconciliation, patient education targeting high-risk medications, post-discharge follow-up phone calls, and bedside discharge prescription delivery. This bundle was expanded to other patient populations through the use of residency-trained pharmacists, pharmacy residents, pharmacy students, and certified pharmacy technicians.
• Results: Challenges were faced when implementing our transitions of care services, including expanding care coordination team coverage with existing resources, training pharmacy staff in new roles, determining the needs of patients cared for by teams we had not previously been integrated into, and creating our discharge prescription delivery program. During this process, we learned to rethink the role of pharmacists on our team, value the support within our institution to create change in order to improve patient care, and continuously evaluate this process.
• Conclusion: We are at an opportune time to expand the scope of the inpatient pharmacist to provide advanced medication-related services to patients. Residency training is creating individuals who will thrive in these new models.

Medication management around the acute care inpatient stay is a challenging but crucial task to ensure patient safety and desired clinical outcomes. The first step in successful medication management is to understand the patient’s medication regimen in the home environment. Patients may take medications differently than prescribed; skip medication doses intentionally to make a supply last longer; use over-the-counter medications, herbal supplements, or someone else’s medication based on the recommendation of family or friends; or discontinue medications based on side effects or media influence. Over the course of the inpatient stay, medication management involves adjusting doses based on changes in organ function, detecting side effects and potential drug interactions, and monitoring clinical outcomes to ensure appropriate drug therapy is being prescribed. As the patient approaches discharge, ensuring the patient understands the indications for his/her medications, has self-monitoring techniques to recognize efficacy or adverse effects, and has access to discharge medications is important. Lastly, long-term medication management includes patient access to pharmaceutical expertise over time. Pharmacists’ involvement in medication therapy management services and patient-centered medical homes is key to ensuring safe and effective medication use over time.

In 2009, the Johns Hopkins Health System Readmission Prevention Task Force developed strategies to reduce preventable readmissions and improve transitions of care. In 2011, a new multidisciplinary approach to patient care was implemented at the Johns Hopkins Hospital (JHH) to optimize care coordination and improve acute care management. Using this approach, care coordination teams composed of physicians, nurses, pharmacists, nurse case managers, social workers, physical/occupational therapists, nutritionists, and home care coordinators meet on a daily basis to discuss the inpatient and discharge care needs of patients in order to improve care transitions and reduce preventable readmissions. In 2012, JHH was awarded a 3-year innovation grant from the Centers for Medicaid & Medicare Services (CMS) that would assist with expansion of these care coordination teams to every unit of the hospital. Prior to implementation of the care coordination model at JHH in 2011, there were 3 pharmacists who consistently rounded on 3 inpatient medicine teams (one pharmacist also had operational responsibilities). Pharmacists were deemed by the task force to be key providers of medication management and, thus, essential members of the care coordination team. Due to an inability to hire a new pharmacist for every care coordination team, the department of pharmacy needed to determine how to provide consistent pharmacist coverage utilizing current resources. This report describes the challenges faced and lessons learned by our adult inpatient pharmacy division when implementing a pharmacy bundle of services to improve care transitions for an adult patient population.

Setting

JHH is an 1192-bed academic teaching hospital located in Baltimore, Maryland. At JHH, the department of pharmacy has 4 inpatient divisions that service the medication needs of different patient populations: medicine, critical care/surgery, oncology, and pediatrics. The adultinpatient pharmacy division covers medicine units in addition to obstetrics, neurology, and surgery units. It is responsible for 486 inpatient beds on 22 units and was the first division to provide the pharmacy bundle of services described below. Currently, 11 rounding and 5 operational pharmacists provide care coordination and order verification support, respectively, for the division during day shift.

Program Overview

Rounding pharmacists on care coordination teams address acute care medication issues and provide a bundle of services that includes targeted patient education, medication reconciliation, post-discharge follow-up phone calls, and discharge prescription planning. The full details of these services have been described [1]. Briefly, patients newly initiated on medications deemed ”high-risk” (eg, anticoagulation, insulin, metered dose inhalers, dual antiplatelets) receive education by a member of the pharmacy team (ie, pharmacist, pharmacy resident, or pharmacy student) prior to discharge. Those patients who receive education are offered a post-discharge follow-up phone call to assess for any questions or issues. Patients who accept this service are contacted 48 to 72 hours post-discharge. Specific patient populations (eg, patients with congestive heart failure, diabetes) are also targeted for completion of medication reconciliation. If patients are being discharged with prescriptions, they are offered our “Meds for Home” service. Patients who accept this service have their prescriptions filled at one of our outpatient pharmacies and delivered to the unit prior to discharge. Highly trained certified pharmacy technicians, called “Meds for Home” coordinators (MHCs; previously known as transitions pharmacist extenders), facilitate this process.

Challenges Faced

Care Coordination Team Coverage

One challenge to implementation of the pharmacy bundle of services was providing consistent team coverage with adequately trained pharmacists. It was not feasible to hire a pharmacist to cover each of the care coordination teams. To address gaps in coverage, we initially utilized postgraduate year 1 and 2 (PGY1 and 2) pharmacy residents on an internal medicine rotation to cover care coordination teams without a rounding pharmacist. However, this method proved unreliable as a pharmacy resident was not scheduled for an internal medicine rotation each month. In the beginning, our division had 3 rounding and 9 operational pharmacists during day shift. To provide sufficient clinical coverage while still adequately addressing order verification needs, a major restructuring of our pharmacy model was necessary. We increased the bed-to-pharmacist ratio for order verification, which allowed the number of operational pharmacists to decrease from 9 to 5. Those 4 remaining pharmacists were now available to serve as rounding pharmacists. Along with hiring 2 additional rounding pharmacists with funding from the CMS innovation grant, we were able to increase the number of care coordination teams consistently covered from 3 to 9.

Although we expanded pharmacist coverage of care coordination teams, time constraints prevented all patients who met criteria for patient education or medication reconciliation to have these services completed in a timely manner or at all by a pharmacist. Our rounding pharmacists’ responsibilities also included participation in high-level activities such as order set reviews for a new provider order entry system, ambulatory clinic time, stewardship activities, and quality improvement projects. In order to increase our scope, we utilized pharmacy technicians, students, and residents to assist with completing these tasks. All pharmacy students and residents on rotation within our division participated in a daily huddle Monday through Friday. Rounding pharmacists whose unit had patient education needs that could not be met by that pharmacist submitted requests by a set time. Those patient education tasks were then divided amongst the pharmacy learners at the huddle for completion. Prior to being allowed to independently counsel patients, pharmacy learners’ patient education skills were evaluated by preceptors. To facilitate timely completion of medication histories, technicians were hired. These medication history technicians are available Monday through Friday to complete medication histories for patients admitted to specific medicine units, ideally within 24 hours of admission. Rounding pharmacists are notified of completion of medication histories via our electronic medical record and reconcile that list with the patient’s inpatient medication list. Any clinically relevant discrepancies are communicated to providers. Pharmacy learners may also collect medication histories.

Training Rounding Pharmacists

Another challenge we faced was providing adequate training for operational pharmacists transitioning to a rounding position. Residency training is crucial in providing the level of skill necessary to identify complex drug therapy problems, adjust treatment regimens, and create plans where limited data exist to drive drug therapy recommendations [2,3]. Rotations during the final year of pharmacy school provide exposure to interacting with patients and providers. Completion of PGY1 residency training allows a pharmacist to practice as a generalist with a broad range of experiences provided during the year to identify medication-related problems. PGY2 residency training allows the pharmacist to spend a concentrated year in the chosen area of expertise and gain a deeper knowledge of medication use in a specific patient population or area of practice [2]. After 2 years of clinical residency training, pharmacists have the skills to interact with patients and multidisciplinary teams to optimize medication regimens, provide medication education, and measure the value they bring to the health care of patients.

Some of the operational pharmacists who were transitioning to the rounding pharmacist role had no training beyond pharmacy school or had only completed a PGY1 pharmacy residency. Initially, training for this new role lasted only a few days and consisted of orientation to the unit and observation of care coordination rounds. We learned that this brief amount of training was insufficient, even for those with PGY1 pharmacy residency training. In order to ensure that these rounding pharmacists could successfully provide the bundle of services and meet the high clinical demands of the inpatient service, we developed a comprehensive training program. Those interested in transitioning from an operational to a rounding pharmacist role must now complete a 6-week training program. The first 2 weeks consists of improving patient education and medication history skills. The remaining 4 weeks are spent honing clinical rounding skills. Rounding pharmacists-in-training also receive a formal review of their performance utilizing an evaluation form developed by the American Society of Health-System Pharmacists (ASHP) for pharmacy residents.

Establishing a Pharmacy Bundle and the Role of a Rounding Pharmacist on New Units

Some of the units implementing care coordination teams, such as neurology, did not previously have a pharmacist rounding on those units. Furthermore, these units had a high patient census (eg, 60 patients), which made it difficult for one pharmacist to clinically evaluate every patient. Multiple specialty teams also admitted patients to a single unit, which made it challenging for the pharmacist to develop strong working relationships with providers. As such, rounding pharmacists deployed to those units had difficulty establishing their role on the team, especially for those pharmacists without or with only 1 year of postgraduate training. To address this issue, a PGY2-trained pharmacist rounded on the unit to assess which areas/teams had the greatest need for a pharmacist. Completing this needs assessment on these units allowed for the rounding pharmacist to more effectively use his/her time. It also allowed for a smoother transition from operational to rounding pharmacist by removing the burden of establishing a brand new role and identifying necessary tasks to be completed throughout the day.

We also discovered on these new care coordination units that our patient criteria for education and medication reconciliation were not universal. We developed and initiated our pharmacy bundle of services in a medical patient population. As we expanded these services to other patient care areas, the targeted list of medications/conditions changed. For example, surgical patients had a greater need for education around opioid therapy and complex bowel regimens while neurology patients needed education regarding antiepileptic regimens. Similarly, patients requiring medication reconciliation also changed. Nurses were performing medication reconciliation for patients with elective surgeries and had a system that worked for that population. Therefore, we did not need to focus efforts for this population around medication reconciliation and could shift our focus more towards medication education.

Optimizing the Delivery of Discharge Prescriptions

The Meds for Home workflow has been updated multiple times since implementation. These changes resulted from early and frequent meetings with nurses, case managers, providers, and the pharmacy team. The Meds for Home service uses an outpatient pharmacy located within the hospital that has high prescription volumes at baseline to fill discharge prescriptions. Due to the volume of out-patient prescriptions and unexpected discharges, delays in prescription delivery occurred. To improve efficiency, a separate workflow and space were designated for filling Meds for Home prescriptions. Initially, MHCs were visiting floors to pick-up and deliver prescriptions at set times (ie, 10 am, 2 pm, and 5 pm). Instead of using set pick-up and delivery times, the Meds for Home service now uses a rolling 2-hour turnaround time during service hours. Additionally, providers, case managers, and units were educated to provide discharge prescriptions, especially those requiring prior authorization, as early as possible to expedite service. By identifying these issues early in the process, we were able to develop a different strategy that worked for the units, providers, and pharmacy.

Lessons Learned

The time of transition from one level of care to another is a vulnerable time for patients, as it is a time when medication-related problems often arise. In an elderly patient population, one study demonstrated that contributing factors for medication discrepancies following hospital discharge included unintended nonadherence and inadequate discharge instructions, and patients experiencing a medication discrepancy were at a significantly higher risk of readmission [4]. Hospital readmissions have also been linked to a lack of adequate follow-up in the outpatient setting [5]. Pharmacists should become more involved in preventing medication-related problems during the times of transition by performing activities such as medication reconciliation, patient education, and assessment of patient outcomes post-discharge [6,7]. Studies have demonstrated that pharmacists are able to reduce medication-related adverse events during and after hospitalization by completing these activities [8–10]. Residency-trained pharmacists are well-equipped to provide these services and are needed to create new processes and models to meet the ever changing demands of health care payers and accrediting bodies. ASHP recommends pharmacists entering into careers in health systems be at least PGY1-trained while the American College of Clinical Pharmacy (ACCP) envisions all pharmacists involved in direct patient care complete residency training [11,12]. Health systems will continue to be challenged with transforming pharmacy models to allow for this influx of highly trained individuals in a time of budget constraints. Below, we describe the lessons we learned while implementing our pharmacy bundle of services and think are essential for other institutions to consider when initiating their own services.

Rethink the Role of the Pharmacist

As health systems acquire smaller hospitals, the role of the pharmacist may need to be redefined and reinvented. The responsibilities of a pharmacist in a large academic hospital may be different than those of a pharmacist with the same skill set in a community hospital. However, despite the difference in practice setting, the same core pharmacy services around medication use can still be deployed. Participation in transitions of care activities is a relatively new concept for many pharmacists as residency training programs traditionally focused on caring for patients within a defined setting such as the intensive care unit or ambulatory care. The pharmacy profession should define the role of the clinical pharmacist in order to make the incorporation of transitions of care responsibilities into job expectations easier for all. The ACCP outlines this need and sets forth recommendations for clinical pharmacists’ responsibilities within the health care team to include assessing patients and medication regimens, developing and implementing medication-related therapy plans, and evaluating clinical outcomes [13]. Pharmacy leadership organizations, including ASHP and ACCP, offer resources providing the vision of pharmacy practice and expectations for which institutions should be reaching. Pharmacy departments should use these resources to complete gap analyses of current processes and those envisioned for the future to help guide efforts for change at their own institutions.

Obtain Support Within Your Institution

Gaining support from hospital leadership for advancing pharmacists’ involvement in patient care is instrumental. Without leadership support at both the institutional and department of pharmacy levels, pharmacists with advanced training may be hindered from practicing at the top of their license. Furthermore, support by leadership of pharmacy residency programs and experiential student learning sites at the institution is also important. Pharmacy residents and students became indispensable in our model and allowed us to expand our reach to more patients. We used residents to cover additional teams that were previously uncovered by a rounding pharmacist and, along with students, provide medication reconciliation, patient education, and follow-up phone calls to more patients. Requiring participation in the pharmacy bundle of services for rotations also allowed us to train these individuals about the value of transitions of care and see the challenges patients face in gaining access to medications. In a survey of academic medical center executives, pharmacy directors, and pharmacists at 8 institutions, residents were noted to add value to the institution through decreasing drug-related errors and drug costs, expansion of clinical services, and enhancing opportunities for research [14].

Support from other disciplines is also essential. Collaborating with other disciplines should occur prior to, during, and beyond implementation. We collaborated with providers, nurses, case managers, social workers and many other disciplines during all phases of the process. Being inclusive during the planning process allowed everyone to understand each other’s role and to provide input on how we could work together to best utilize everyone’s resources. This multidisciplinary approach to developing pharmacy services also allowed an opportunity to collaborate on research and evaluate our processes with other disciplines.

Tracking interventions will demonstrate the value of pharmacists, technicians, and other pharmacy team members participating in these advanced roles. This information will be useful when justifying the practice model to hospital leadership and for recruiting new pharmacists, residents, and technicians to the institution. Additionally, defining both outcome (eg, 30-day readmission rates, HCAHPS scores) and process (eg, number of patient education sessions performed, number of medication discrepancies reconciled) measures upfront is important in order for those involved to understand how their work will be assessed. These data will be useful in determining whether the intervention is making an impact early on and allow for restructuring of the process if not.

Create Depth in Your Team While Engaging Current Resources

We spent a significant amount of time planning the implementation of our pharmacy bundle of services, collaborating with other disciplines, and training our pharmacy team members. We hired highly trained and competent people into new positions and ensured every-one clearly understood their responsibilities. This was a critical step in order to ensure we were providing optimal care to our patients and integrating leaders into our team. We also utilized our current workforce to fill new clinical rounding pharmacist or technician roles. For those pharmacists who had not completed a residency, we required the pharmacists to complete a compact training program similar to that required of our residents [1]. This training ensured that important services were being performed adequately by each rounding pharmacist. Similarly, technicians transitioning from a primarily medication dispensing role to a MHC or medication history role received extensive training to assist with developing their new skill set.

Creating relationships with an outpatient pharmacy is essential to ensure patients are discharged from the hospital on medications they can afford long-term. We are fortunate to have 5 outpatient pharmacies on the JHH campus that are under the Johns Hopkins Health System umbrella, which made collaboration between the inpatient and outpatient teams seamless. However, many hospitals may not be directly affiliated with an outpatient pharmacy with which to collaborate or may contract with a retail chain pharmacy. In the latter case, inpatient and outpatient pharmacies must work together to define roles around transitions of care and how to best serve the patient in a collaborative manner. If no onsite outpatient pharmacy exists, dedicated resources should be acquired to serve as a liaison between the inpatient team and the outpatient pharmacy. These resources may work through issues such as formulary preferences, prior authorization requests, and connecting the patient to the medication either through bedside delivery or filling at the patient’s community pharmacy. Community pharmacies recognize the cost benefit they could gain through 340B pricing and specialty drug dispensing when working in collaboration with healthcare systems. However, health systems must be aware that collaborating with outpatient pharmacy partnerships will create further challenges as providers ensure patient preference for use of a particular pharmacy is honored and cost-sharing is incorporated into models.

Continuously Reevaluate Your Services

As implementation of our pharmacy bundle of services began, meeting early and often was essential to identify issues and adjust our workflow to resolve those issues quickly. When the inpatient component of the pharmacy bundle of services was first implemented, rounding pharmacists and pharmacy leadership initially met on a weekly basis to provide feedback on the practice model and develop resolutions for any issues. However, it is important to also include other disciplines in the evaluation process. For the Meds for Home program, pharmacy leadership not only met with MHCs but also with providers, nurses, case managers, and social workers for feedback on how to improve the service. Although the workflow of our pharmacy bundle of services are more established, evaluations still occur albeit less frequently.

Conclusion

Pharmacists’ involvement in transitions of care should become part of the daily responsibility. Health systems should understand how efforts to expand pharmacists’ interventions align with overall hospital goals. Many hospitals may already have programs in place to help with transitions of care. Pharmacists can help expand current efforts through increased visibility to physicians and patients as well as collaboration with outpatient pharmacies to ensure medications are effective and affordable for patients long-term.

Note: The project described was supported by grant no. 1C1CMS331053-01-00 from the U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services. The content of this paper is solely the responsibility of the authors and does not necessarily represent the official views of the U.S. Department of Health and Human Services or any of its agencies. The research presented was conducted by the awardee. Findings may or may not be consistent with or confirmed by the findings of the independent evaluation contractor.

Corresponding author: Vi Gilmore, PharmD, BCPS, Clinical Pharmacy Specialist, Internal Medicine, The Johns Hopkins Hospital, 600 N. Wolfe Street, Carnegie 180, Baltimore, MD 21287, [email protected].

Financial disclosures: None.

From The Johns Hopkins Hospital, Baltimore, MD.

The project described was supported by grant # 1C1CMS331053-01-00 from the U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services. The content of this paper is solely the responsibility of the authors and does not necessarily represent the official views of the U.S. Department of Health and Human Services or any of its agencies. The research presented was conducted by the awardee. Findings may or may not be consistent with or confirmed by the findings of the independent evaluation contractor.

Abstract

• Background: Medication management is becoming more complex, with new medications entering the market, drug prices increasing, and patients transferring into and out of the hospital. Transitions of care services are being implemented to prevent readmissions and increase patient satisfaction. Pharmacists play a key role by expanding clinical services provided to patients around medication management.
• Objective: To describe a pharmacy transitions of care model at a large academic teaching hospital and lessons learned during implementation.
• Methods: A pharmacy bundle of services was initially developed in a medical patient population and included medication reconciliation, patient education targeting high-risk medications, post-discharge follow-up phone calls, and bedside discharge prescription delivery. This bundle was expanded to other patient populations through the use of residency-trained pharmacists, pharmacy residents, pharmacy students, and certified pharmacy technicians.
• Results: Challenges were faced when implementing our transitions of care services, including expanding care coordination team coverage with existing resources, training pharmacy staff in new roles, determining the needs of patients cared for by teams we had not previously been integrated into, and creating our discharge prescription delivery program. During this process, we learned to rethink the role of pharmacists on our team, value the support within our institution to create change in order to improve patient care, and continuously evaluate this process.
• Conclusion: We are at an opportune time to expand the scope of the inpatient pharmacist to provide advanced medication-related services to patients. Residency training is creating individuals who will thrive in these new models.

Medication management around the acute care inpatient stay is a challenging but crucial task to ensure patient safety and desired clinical outcomes. The first step in successful medication management is to understand the patient’s medication regimen in the home environment. Patients may take medications differently than prescribed; skip medication doses intentionally to make a supply last longer; use over-the-counter medications, herbal supplements, or someone else’s medication based on the recommendation of family or friends; or discontinue medications based on side effects or media influence. Over the course of the inpatient stay, medication management involves adjusting doses based on changes in organ function, detecting side effects and potential drug interactions, and monitoring clinical outcomes to ensure appropriate drug therapy is being prescribed. As the patient approaches discharge, ensuring the patient understands the indications for his/her medications, has self-monitoring techniques to recognize efficacy or adverse effects, and has access to discharge medications is important. Lastly, long-term medication management includes patient access to pharmaceutical expertise over time. Pharmacists’ involvement in medication therapy management services and patient-centered medical homes is key to ensuring safe and effective medication use over time.

In 2009, the Johns Hopkins Health System Readmission Prevention Task Force developed strategies to reduce preventable readmissions and improve transitions of care. In 2011, a new multidisciplinary approach to patient care was implemented at the Johns Hopkins Hospital (JHH) to optimize care coordination and improve acute care management. Using this approach, care coordination teams composed of physicians, nurses, pharmacists, nurse case managers, social workers, physical/occupational therapists, nutritionists, and home care coordinators meet on a daily basis to discuss the inpatient and discharge care needs of patients in order to improve care transitions and reduce preventable readmissions. In 2012, JHH was awarded a 3-year innovation grant from the Centers for Medicaid & Medicare Services (CMS) that would assist with expansion of these care coordination teams to every unit of the hospital. Prior to implementation of the care coordination model at JHH in 2011, there were 3 pharmacists who consistently rounded on 3 inpatient medicine teams (one pharmacist also had operational responsibilities). Pharmacists were deemed by the task force to be key providers of medication management and, thus, essential members of the care coordination team. Due to an inability to hire a new pharmacist for every care coordination team, the department of pharmacy needed to determine how to provide consistent pharmacist coverage utilizing current resources. This report describes the challenges faced and lessons learned by our adult inpatient pharmacy division when implementing a pharmacy bundle of services to improve care transitions for an adult patient population.

Setting

JHH is an 1192-bed academic teaching hospital located in Baltimore, Maryland. At JHH, the department of pharmacy has 4 inpatient divisions that service the medication needs of different patient populations: medicine, critical care/surgery, oncology, and pediatrics. The adultinpatient pharmacy division covers medicine units in addition to obstetrics, neurology, and surgery units. It is responsible for 486 inpatient beds on 22 units and was the first division to provide the pharmacy bundle of services described below. Currently, 11 rounding and 5 operational pharmacists provide care coordination and order verification support, respectively, for the division during day shift.

Program Overview

Rounding pharmacists on care coordination teams address acute care medication issues and provide a bundle of services that includes targeted patient education, medication reconciliation, post-discharge follow-up phone calls, and discharge prescription planning. The full details of these services have been described [1]. Briefly, patients newly initiated on medications deemed ”high-risk” (eg, anticoagulation, insulin, metered dose inhalers, dual antiplatelets) receive education by a member of the pharmacy team (ie, pharmacist, pharmacy resident, or pharmacy student) prior to discharge. Those patients who receive education are offered a post-discharge follow-up phone call to assess for any questions or issues. Patients who accept this service are contacted 48 to 72 hours post-discharge. Specific patient populations (eg, patients with congestive heart failure, diabetes) are also targeted for completion of medication reconciliation. If patients are being discharged with prescriptions, they are offered our “Meds for Home” service. Patients who accept this service have their prescriptions filled at one of our outpatient pharmacies and delivered to the unit prior to discharge. Highly trained certified pharmacy technicians, called “Meds for Home” coordinators (MHCs; previously known as transitions pharmacist extenders), facilitate this process.

Challenges Faced

Care Coordination Team Coverage

One challenge to implementation of the pharmacy bundle of services was providing consistent team coverage with adequately trained pharmacists. It was not feasible to hire a pharmacist to cover each of the care coordination teams. To address gaps in coverage, we initially utilized postgraduate year 1 and 2 (PGY1 and 2) pharmacy residents on an internal medicine rotation to cover care coordination teams without a rounding pharmacist. However, this method proved unreliable as a pharmacy resident was not scheduled for an internal medicine rotation each month. In the beginning, our division had 3 rounding and 9 operational pharmacists during day shift. To provide sufficient clinical coverage while still adequately addressing order verification needs, a major restructuring of our pharmacy model was necessary. We increased the bed-to-pharmacist ratio for order verification, which allowed the number of operational pharmacists to decrease from 9 to 5. Those 4 remaining pharmacists were now available to serve as rounding pharmacists. Along with hiring 2 additional rounding pharmacists with funding from the CMS innovation grant, we were able to increase the number of care coordination teams consistently covered from 3 to 9.

Although we expanded pharmacist coverage of care coordination teams, time constraints prevented all patients who met criteria for patient education or medication reconciliation to have these services completed in a timely manner or at all by a pharmacist. Our rounding pharmacists’ responsibilities also included participation in high-level activities such as order set reviews for a new provider order entry system, ambulatory clinic time, stewardship activities, and quality improvement projects. In order to increase our scope, we utilized pharmacy technicians, students, and residents to assist with completing these tasks. All pharmacy students and residents on rotation within our division participated in a daily huddle Monday through Friday. Rounding pharmacists whose unit had patient education needs that could not be met by that pharmacist submitted requests by a set time. Those patient education tasks were then divided amongst the pharmacy learners at the huddle for completion. Prior to being allowed to independently counsel patients, pharmacy learners’ patient education skills were evaluated by preceptors. To facilitate timely completion of medication histories, technicians were hired. These medication history technicians are available Monday through Friday to complete medication histories for patients admitted to specific medicine units, ideally within 24 hours of admission. Rounding pharmacists are notified of completion of medication histories via our electronic medical record and reconcile that list with the patient’s inpatient medication list. Any clinically relevant discrepancies are communicated to providers. Pharmacy learners may also collect medication histories.

Training Rounding Pharmacists

Another challenge we faced was providing adequate training for operational pharmacists transitioning to a rounding position. Residency training is crucial in providing the level of skill necessary to identify complex drug therapy problems, adjust treatment regimens, and create plans where limited data exist to drive drug therapy recommendations [2,3]. Rotations during the final year of pharmacy school provide exposure to interacting with patients and providers. Completion of PGY1 residency training allows a pharmacist to practice as a generalist with a broad range of experiences provided during the year to identify medication-related problems. PGY2 residency training allows the pharmacist to spend a concentrated year in the chosen area of expertise and gain a deeper knowledge of medication use in a specific patient population or area of practice [2]. After 2 years of clinical residency training, pharmacists have the skills to interact with patients and multidisciplinary teams to optimize medication regimens, provide medication education, and measure the value they bring to the health care of patients.

Some of the operational pharmacists who were transitioning to the rounding pharmacist role had no training beyond pharmacy school or had only completed a PGY1 pharmacy residency. Initially, training for this new role lasted only a few days and consisted of orientation to the unit and observation of care coordination rounds. We learned that this brief amount of training was insufficient, even for those with PGY1 pharmacy residency training. In order to ensure that these rounding pharmacists could successfully provide the bundle of services and meet the high clinical demands of the inpatient service, we developed a comprehensive training program. Those interested in transitioning from an operational to a rounding pharmacist role must now complete a 6-week training program. The first 2 weeks consists of improving patient education and medication history skills. The remaining 4 weeks are spent honing clinical rounding skills. Rounding pharmacists-in-training also receive a formal review of their performance utilizing an evaluation form developed by the American Society of Health-System Pharmacists (ASHP) for pharmacy residents.

Establishing a Pharmacy Bundle and the Role of a Rounding Pharmacist on New Units

Some of the units implementing care coordination teams, such as neurology, did not previously have a pharmacist rounding on those units. Furthermore, these units had a high patient census (eg, 60 patients), which made it difficult for one pharmacist to clinically evaluate every patient. Multiple specialty teams also admitted patients to a single unit, which made it challenging for the pharmacist to develop strong working relationships with providers. As such, rounding pharmacists deployed to those units had difficulty establishing their role on the team, especially for those pharmacists without or with only 1 year of postgraduate training. To address this issue, a PGY2-trained pharmacist rounded on the unit to assess which areas/teams had the greatest need for a pharmacist. Completing this needs assessment on these units allowed for the rounding pharmacist to more effectively use his/her time. It also allowed for a smoother transition from operational to rounding pharmacist by removing the burden of establishing a brand new role and identifying necessary tasks to be completed throughout the day.

We also discovered on these new care coordination units that our patient criteria for education and medication reconciliation were not universal. We developed and initiated our pharmacy bundle of services in a medical patient population. As we expanded these services to other patient care areas, the targeted list of medications/conditions changed. For example, surgical patients had a greater need for education around opioid therapy and complex bowel regimens while neurology patients needed education regarding antiepileptic regimens. Similarly, patients requiring medication reconciliation also changed. Nurses were performing medication reconciliation for patients with elective surgeries and had a system that worked for that population. Therefore, we did not need to focus efforts for this population around medication reconciliation and could shift our focus more towards medication education.

Optimizing the Delivery of Discharge Prescriptions

The Meds for Home workflow has been updated multiple times since implementation. These changes resulted from early and frequent meetings with nurses, case managers, providers, and the pharmacy team. The Meds for Home service uses an outpatient pharmacy located within the hospital that has high prescription volumes at baseline to fill discharge prescriptions. Due to the volume of out-patient prescriptions and unexpected discharges, delays in prescription delivery occurred. To improve efficiency, a separate workflow and space were designated for filling Meds for Home prescriptions. Initially, MHCs were visiting floors to pick-up and deliver prescriptions at set times (ie, 10 am, 2 pm, and 5 pm). Instead of using set pick-up and delivery times, the Meds for Home service now uses a rolling 2-hour turnaround time during service hours. Additionally, providers, case managers, and units were educated to provide discharge prescriptions, especially those requiring prior authorization, as early as possible to expedite service. By identifying these issues early in the process, we were able to develop a different strategy that worked for the units, providers, and pharmacy.

Lessons Learned

The time of transition from one level of care to another is a vulnerable time for patients, as it is a time when medication-related problems often arise. In an elderly patient population, one study demonstrated that contributing factors for medication discrepancies following hospital discharge included unintended nonadherence and inadequate discharge instructions, and patients experiencing a medication discrepancy were at a significantly higher risk of readmission [4]. Hospital readmissions have also been linked to a lack of adequate follow-up in the outpatient setting [5]. Pharmacists should become more involved in preventing medication-related problems during the times of transition by performing activities such as medication reconciliation, patient education, and assessment of patient outcomes post-discharge [6,7]. Studies have demonstrated that pharmacists are able to reduce medication-related adverse events during and after hospitalization by completing these activities [8–10]. Residency-trained pharmacists are well-equipped to provide these services and are needed to create new processes and models to meet the ever changing demands of health care payers and accrediting bodies. ASHP recommends pharmacists entering into careers in health systems be at least PGY1-trained while the American College of Clinical Pharmacy (ACCP) envisions all pharmacists involved in direct patient care complete residency training [11,12]. Health systems will continue to be challenged with transforming pharmacy models to allow for this influx of highly trained individuals in a time of budget constraints. Below, we describe the lessons we learned while implementing our pharmacy bundle of services and think are essential for other institutions to consider when initiating their own services.

Rethink the Role of the Pharmacist

As health systems acquire smaller hospitals, the role of the pharmacist may need to be redefined and reinvented. The responsibilities of a pharmacist in a large academic hospital may be different than those of a pharmacist with the same skill set in a community hospital. However, despite the difference in practice setting, the same core pharmacy services around medication use can still be deployed. Participation in transitions of care activities is a relatively new concept for many pharmacists as residency training programs traditionally focused on caring for patients within a defined setting such as the intensive care unit or ambulatory care. The pharmacy profession should define the role of the clinical pharmacist in order to make the incorporation of transitions of care responsibilities into job expectations easier for all. The ACCP outlines this need and sets forth recommendations for clinical pharmacists’ responsibilities within the health care team to include assessing patients and medication regimens, developing and implementing medication-related therapy plans, and evaluating clinical outcomes [13]. Pharmacy leadership organizations, including ASHP and ACCP, offer resources providing the vision of pharmacy practice and expectations for which institutions should be reaching. Pharmacy departments should use these resources to complete gap analyses of current processes and those envisioned for the future to help guide efforts for change at their own institutions.

Obtain Support Within Your Institution

Gaining support from hospital leadership for advancing pharmacists’ involvement in patient care is instrumental. Without leadership support at both the institutional and department of pharmacy levels, pharmacists with advanced training may be hindered from practicing at the top of their license. Furthermore, support by leadership of pharmacy residency programs and experiential student learning sites at the institution is also important. Pharmacy residents and students became indispensable in our model and allowed us to expand our reach to more patients. We used residents to cover additional teams that were previously uncovered by a rounding pharmacist and, along with students, provide medication reconciliation, patient education, and follow-up phone calls to more patients. Requiring participation in the pharmacy bundle of services for rotations also allowed us to train these individuals about the value of transitions of care and see the challenges patients face in gaining access to medications. In a survey of academic medical center executives, pharmacy directors, and pharmacists at 8 institutions, residents were noted to add value to the institution through decreasing drug-related errors and drug costs, expansion of clinical services, and enhancing opportunities for research [14].

Support from other disciplines is also essential. Collaborating with other disciplines should occur prior to, during, and beyond implementation. We collaborated with providers, nurses, case managers, social workers and many other disciplines during all phases of the process. Being inclusive during the planning process allowed everyone to understand each other’s role and to provide input on how we could work together to best utilize everyone’s resources. This multidisciplinary approach to developing pharmacy services also allowed an opportunity to collaborate on research and evaluate our processes with other disciplines.

Tracking interventions will demonstrate the value of pharmacists, technicians, and other pharmacy team members participating in these advanced roles. This information will be useful when justifying the practice model to hospital leadership and for recruiting new pharmacists, residents, and technicians to the institution. Additionally, defining both outcome (eg, 30-day readmission rates, HCAHPS scores) and process (eg, number of patient education sessions performed, number of medication discrepancies reconciled) measures upfront is important in order for those involved to understand how their work will be assessed. These data will be useful in determining whether the intervention is making an impact early on and allow for restructuring of the process if not.

Create Depth in Your Team While Engaging Current Resources

We spent a significant amount of time planning the implementation of our pharmacy bundle of services, collaborating with other disciplines, and training our pharmacy team members. We hired highly trained and competent people into new positions and ensured every-one clearly understood their responsibilities. This was a critical step in order to ensure we were providing optimal care to our patients and integrating leaders into our team. We also utilized our current workforce to fill new clinical rounding pharmacist or technician roles. For those pharmacists who had not completed a residency, we required the pharmacists to complete a compact training program similar to that required of our residents [1]. This training ensured that important services were being performed adequately by each rounding pharmacist. Similarly, technicians transitioning from a primarily medication dispensing role to a MHC or medication history role received extensive training to assist with developing their new skill set.

Creating relationships with an outpatient pharmacy is essential to ensure patients are discharged from the hospital on medications they can afford long-term. We are fortunate to have 5 outpatient pharmacies on the JHH campus that are under the Johns Hopkins Health System umbrella, which made collaboration between the inpatient and outpatient teams seamless. However, many hospitals may not be directly affiliated with an outpatient pharmacy with which to collaborate or may contract with a retail chain pharmacy. In the latter case, inpatient and outpatient pharmacies must work together to define roles around transitions of care and how to best serve the patient in a collaborative manner. If no onsite outpatient pharmacy exists, dedicated resources should be acquired to serve as a liaison between the inpatient team and the outpatient pharmacy. These resources may work through issues such as formulary preferences, prior authorization requests, and connecting the patient to the medication either through bedside delivery or filling at the patient’s community pharmacy. Community pharmacies recognize the cost benefit they could gain through 340B pricing and specialty drug dispensing when working in collaboration with healthcare systems. However, health systems must be aware that collaborating with outpatient pharmacy partnerships will create further challenges as providers ensure patient preference for use of a particular pharmacy is honored and cost-sharing is incorporated into models.

Continuously Reevaluate Your Services

As implementation of our pharmacy bundle of services began, meeting early and often was essential to identify issues and adjust our workflow to resolve those issues quickly. When the inpatient component of the pharmacy bundle of services was first implemented, rounding pharmacists and pharmacy leadership initially met on a weekly basis to provide feedback on the practice model and develop resolutions for any issues. However, it is important to also include other disciplines in the evaluation process. For the Meds for Home program, pharmacy leadership not only met with MHCs but also with providers, nurses, case managers, and social workers for feedback on how to improve the service. Although the workflow of our pharmacy bundle of services are more established, evaluations still occur albeit less frequently.

Conclusion

Pharmacists’ involvement in transitions of care should become part of the daily responsibility. Health systems should understand how efforts to expand pharmacists’ interventions align with overall hospital goals. Many hospitals may already have programs in place to help with transitions of care. Pharmacists can help expand current efforts through increased visibility to physicians and patients as well as collaboration with outpatient pharmacies to ensure medications are effective and affordable for patients long-term.

Note: The project described was supported by grant no. 1C1CMS331053-01-00 from the U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services. The content of this paper is solely the responsibility of the authors and does not necessarily represent the official views of the U.S. Department of Health and Human Services or any of its agencies. The research presented was conducted by the awardee. Findings may or may not be consistent with or confirmed by the findings of the independent evaluation contractor.

Corresponding author: Vi Gilmore, PharmD, BCPS, Clinical Pharmacy Specialist, Internal Medicine, The Johns Hopkins Hospital, 600 N. Wolfe Street, Carnegie 180, Baltimore, MD 21287, [email protected].

Financial disclosures: None.

Study Overview

Objective. To describe the feasibility of a primary care–based group visit model focused on advance care planning.

Design. Qualitative study.

Setting and participants. Participants were patients attending the Senior Clinic, a patient-centered medical home at the University of Colorado Hospital in Aurora, CO. Patients had to be aged 65, English speakers, and receiving primary care at the Clinic. Participants could be referred by their primary care clinician, a partner or friend, or self-refer in response to flyers. Clinicians were not asked to prioritize patients with poor health status or known end-of-life needs.

Intervention. Groups of patients met for 2 sessions (1 month apart), each 2 hours in length, facilitated by a geriatrician and a social worker. About 1 hour was spent on discussion of advance care planning concepts, including sharing experiences and considering values. Other time in the session was for introductions/rapport building, individual goal setting, and optional completion or directives and/or individual clinical visits. Facilitators were supported by a Facilitator’s Communication Guide and used educational materials and handouts with the group.

Main outcome measures. Researchers used the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to evaluate the project.

Main results. Patients were referred by 10 out of 11 clinicians. Of 80 patients approached, 32 participated in 5 group visit cohorts (40% participation rate) and 27 participated in both sessions (84% retention rate). Mean age was 79 years; 59% of participants were female and 72% white. Most evaluated the group visit as better than usual clinic visits for discussing advance care planning. Patients reported increases in detailed advance care planning conversations after participating (19% to 41%, P = 0.02). Patients were willing to share personal values and challenges related to advance care planning and they initiated discussions about a broad range of relevant topics.

Conclusion. A group visit to facilitate discussions about advance care planning and increase patient engagement is feasible. This model warrants further evaluation for effectiveness in improving advance care planning outcomes for patients, clinicians, and the system.

Commentary

An understanding of patients’ care goals is an essential element of high-quality care, allowing clinicians to align the care provided with what is most important to the patient [1]. Existing evidence does not support the commonly held belief that communication about end-of-life issues increases patient distress [1]. Early discussions about goals of care are associated with better quality of life, reduced use of nonbeneficial medical care near death, enhanced goal-consistent care, positive family outcomes, and reduced costs; however, significant barriers to having advance care planning discussions exist [2], including communication issues and lack of appropriate counseling by clinicians in primary care. Clinicians cite limited time and lack of clinic-based support as factors that impede discussions with patients about advance care planning.

New models are being developed in order to facilitate the process. Group medical visits have been recognized as a useful and effective strategy for approaching patients [1]. The current study describes what the authorssay is the first advance care planning group visit, which they named the “Conversation Group Medical Visit” (CGMV). Its aim is to engage patients in a discussion of key advance care planning concepts and support patient-initiated advance care planning actions, such as choosing surrogate decision makers, deciding on preferences during serious illness, discussing preferences with decision makers and health care providers, and documenting advance directives in the electronic health record [3].

As part of the group medical visits, participants receive an agenda, a personal copy of their EHR highlighting current advance care planning documentation, if any, and a blank medical durable power of attorney form. Facilitators use educational materials including videos from the PREPARE website (prepareforyourcare.org) that demonstrate a family’s conversation, advance directives, and various degrees of flexibility in the decision-making role. A Conversation Starter Kit is also used, which prompts individuals to think about their values and guides conversations about preferences.

Researcher used the RE-AIM framework [4] to evaluate the implementation of this group medical visit model. This framework looks at Reach (if older adults would participate in the medical group visits), Effectiveness (related to participant’s engagement in the conversations), the Adoption of the model by health providers (clinician referral patterns), Implementation (related to the attendance of patients at both clinical and group visits and aspects of planning discussed), and Maintenance (not assessed in this study).

There was a 40% participation rate. Reasons given for declining to participate were having participated in past advance care planning conversation or having an existing advance directive (30%), lack of interest (13%), illness (3.3%), lack of transportation (3.3%), and other/unknown (50%). Regarding effectiveness, the majority of patients rated the group visit as better than usual clinic visits for talking about advance care planning. Participants reported that they received useful information and felt comfortable talking about advance care planning in the group. In addition, participants reported finding it helpful to talk with others about advance care planning (92%). Participants also reported an overall increase (19% to 41%) in advance care planning conversations with family members after participating in the group visit (P =0.02). Participants said these conversations included enough details that they felt confident that their family members knew their wishes. Thus, enrollment in a CGMV led to improvements in conversation not only between patient and health care provider but also between family members.

Several themes were identified during discussions. Patients shared personal values and challenges related to advance care planning. Also, the facilitated discussions introduced key advance care planning concepts and encouraged patients to share related experiences, questions, successes, and challenges in regards to these topics. An interesting finding was that patients in groups of 4 or 5 seemed less engaged in the discussion than those in groups of 7 to 9 patients.

Applications for Clinical Practice

This novel strategy to faciliate discussions about advance care planning showed promising results and appears feasible, but further study is needed to evaluate the model. It may prove useful as a new model of advance care planning in primary care. Further longitudinal research is encouraged.

 —Paloma Cesar de Sales, BS, RN, MS

Study Overview

Objective. To describe the feasibility of a primary care–based group visit model focused on advance care planning.

Design. Qualitative study.

Setting and participants. Participants were patients attending the Senior Clinic, a patient-centered medical home at the University of Colorado Hospital in Aurora, CO. Patients had to be aged 65, English speakers, and receiving primary care at the Clinic. Participants could be referred by their primary care clinician, a partner or friend, or self-refer in response to flyers. Clinicians were not asked to prioritize patients with poor health status or known end-of-life needs.

Intervention. Groups of patients met for 2 sessions (1 month apart), each 2 hours in length, facilitated by a geriatrician and a social worker. About 1 hour was spent on discussion of advance care planning concepts, including sharing experiences and considering values. Other time in the session was for introductions/rapport building, individual goal setting, and optional completion or directives and/or individual clinical visits. Facilitators were supported by a Facilitator’s Communication Guide and used educational materials and handouts with the group.

Main outcome measures. Researchers used the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to evaluate the project.

Main results. Patients were referred by 10 out of 11 clinicians. Of 80 patients approached, 32 participated in 5 group visit cohorts (40% participation rate) and 27 participated in both sessions (84% retention rate). Mean age was 79 years; 59% of participants were female and 72% white. Most evaluated the group visit as better than usual clinic visits for discussing advance care planning. Patients reported increases in detailed advance care planning conversations after participating (19% to 41%, P = 0.02). Patients were willing to share personal values and challenges related to advance care planning and they initiated discussions about a broad range of relevant topics.

Conclusion. A group visit to facilitate discussions about advance care planning and increase patient engagement is feasible. This model warrants further evaluation for effectiveness in improving advance care planning outcomes for patients, clinicians, and the system.

Commentary

An understanding of patients’ care goals is an essential element of high-quality care, allowing clinicians to align the care provided with what is most important to the patient [1]. Existing evidence does not support the commonly held belief that communication about end-of-life issues increases patient distress [1]. Early discussions about goals of care are associated with better quality of life, reduced use of nonbeneficial medical care near death, enhanced goal-consistent care, positive family outcomes, and reduced costs; however, significant barriers to having advance care planning discussions exist [2], including communication issues and lack of appropriate counseling by clinicians in primary care. Clinicians cite limited time and lack of clinic-based support as factors that impede discussions with patients about advance care planning.

New models are being developed in order to facilitate the process. Group medical visits have been recognized as a useful and effective strategy for approaching patients [1]. The current study describes what the authorssay is the first advance care planning group visit, which they named the “Conversation Group Medical Visit” (CGMV). Its aim is to engage patients in a discussion of key advance care planning concepts and support patient-initiated advance care planning actions, such as choosing surrogate decision makers, deciding on preferences during serious illness, discussing preferences with decision makers and health care providers, and documenting advance directives in the electronic health record [3].

As part of the group medical visits, participants receive an agenda, a personal copy of their EHR highlighting current advance care planning documentation, if any, and a blank medical durable power of attorney form. Facilitators use educational materials including videos from the PREPARE website (prepareforyourcare.org) that demonstrate a family’s conversation, advance directives, and various degrees of flexibility in the decision-making role. A Conversation Starter Kit is also used, which prompts individuals to think about their values and guides conversations about preferences.

Researcher used the RE-AIM framework [4] to evaluate the implementation of this group medical visit model. This framework looks at Reach (if older adults would participate in the medical group visits), Effectiveness (related to participant’s engagement in the conversations), the Adoption of the model by health providers (clinician referral patterns), Implementation (related to the attendance of patients at both clinical and group visits and aspects of planning discussed), and Maintenance (not assessed in this study).

There was a 40% participation rate. Reasons given for declining to participate were having participated in past advance care planning conversation or having an existing advance directive (30%), lack of interest (13%), illness (3.3%), lack of transportation (3.3%), and other/unknown (50%). Regarding effectiveness, the majority of patients rated the group visit as better than usual clinic visits for talking about advance care planning. Participants reported that they received useful information and felt comfortable talking about advance care planning in the group. In addition, participants reported finding it helpful to talk with others about advance care planning (92%). Participants also reported an overall increase (19% to 41%) in advance care planning conversations with family members after participating in the group visit (P =0.02). Participants said these conversations included enough details that they felt confident that their family members knew their wishes. Thus, enrollment in a CGMV led to improvements in conversation not only between patient and health care provider but also between family members.

Several themes were identified during discussions. Patients shared personal values and challenges related to advance care planning. Also, the facilitated discussions introduced key advance care planning concepts and encouraged patients to share related experiences, questions, successes, and challenges in regards to these topics. An interesting finding was that patients in groups of 4 or 5 seemed less engaged in the discussion than those in groups of 7 to 9 patients.

Applications for Clinical Practice

This novel strategy to faciliate discussions about advance care planning showed promising results and appears feasible, but further study is needed to evaluate the model. It may prove useful as a new model of advance care planning in primary care. Further longitudinal research is encouraged.

 —Paloma Cesar de Sales, BS, RN, MS

Study Overview

Objective. To describe the feasibility of a primary care–based group visit model focused on advance care planning.

Design. Qualitative study.

Setting and participants. Participants were patients attending the Senior Clinic, a patient-centered medical home at the University of Colorado Hospital in Aurora, CO. Patients had to be aged 65, English speakers, and receiving primary care at the Clinic. Participants could be referred by their primary care clinician, a partner or friend, or self-refer in response to flyers. Clinicians were not asked to prioritize patients with poor health status or known end-of-life needs.

Intervention. Groups of patients met for 2 sessions (1 month apart), each 2 hours in length, facilitated by a geriatrician and a social worker. About 1 hour was spent on discussion of advance care planning concepts, including sharing experiences and considering values. Other time in the session was for introductions/rapport building, individual goal setting, and optional completion or directives and/or individual clinical visits. Facilitators were supported by a Facilitator’s Communication Guide and used educational materials and handouts with the group.

Main outcome measures. Researchers used the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to evaluate the project.

Main results. Patients were referred by 10 out of 11 clinicians. Of 80 patients approached, 32 participated in 5 group visit cohorts (40% participation rate) and 27 participated in both sessions (84% retention rate). Mean age was 79 years; 59% of participants were female and 72% white. Most evaluated the group visit as better than usual clinic visits for discussing advance care planning. Patients reported increases in detailed advance care planning conversations after participating (19% to 41%, P = 0.02). Patients were willing to share personal values and challenges related to advance care planning and they initiated discussions about a broad range of relevant topics.

Conclusion. A group visit to facilitate discussions about advance care planning and increase patient engagement is feasible. This model warrants further evaluation for effectiveness in improving advance care planning outcomes for patients, clinicians, and the system.

Commentary

An understanding of patients’ care goals is an essential element of high-quality care, allowing clinicians to align the care provided with what is most important to the patient [1]. Existing evidence does not support the commonly held belief that communication about end-of-life issues increases patient distress [1]. Early discussions about goals of care are associated with better quality of life, reduced use of nonbeneficial medical care near death, enhanced goal-consistent care, positive family outcomes, and reduced costs; however, significant barriers to having advance care planning discussions exist [2], including communication issues and lack of appropriate counseling by clinicians in primary care. Clinicians cite limited time and lack of clinic-based support as factors that impede discussions with patients about advance care planning.

New models are being developed in order to facilitate the process. Group medical visits have been recognized as a useful and effective strategy for approaching patients [1]. The current study describes what the authorssay is the first advance care planning group visit, which they named the “Conversation Group Medical Visit” (CGMV). Its aim is to engage patients in a discussion of key advance care planning concepts and support patient-initiated advance care planning actions, such as choosing surrogate decision makers, deciding on preferences during serious illness, discussing preferences with decision makers and health care providers, and documenting advance directives in the electronic health record [3].

As part of the group medical visits, participants receive an agenda, a personal copy of their EHR highlighting current advance care planning documentation, if any, and a blank medical durable power of attorney form. Facilitators use educational materials including videos from the PREPARE website (prepareforyourcare.org) that demonstrate a family’s conversation, advance directives, and various degrees of flexibility in the decision-making role. A Conversation Starter Kit is also used, which prompts individuals to think about their values and guides conversations about preferences.

Researcher used the RE-AIM framework [4] to evaluate the implementation of this group medical visit model. This framework looks at Reach (if older adults would participate in the medical group visits), Effectiveness (related to participant’s engagement in the conversations), the Adoption of the model by health providers (clinician referral patterns), Implementation (related to the attendance of patients at both clinical and group visits and aspects of planning discussed), and Maintenance (not assessed in this study).

There was a 40% participation rate. Reasons given for declining to participate were having participated in past advance care planning conversation or having an existing advance directive (30%), lack of interest (13%), illness (3.3%), lack of transportation (3.3%), and other/unknown (50%). Regarding effectiveness, the majority of patients rated the group visit as better than usual clinic visits for talking about advance care planning. Participants reported that they received useful information and felt comfortable talking about advance care planning in the group. In addition, participants reported finding it helpful to talk with others about advance care planning (92%). Participants also reported an overall increase (19% to 41%) in advance care planning conversations with family members after participating in the group visit (P =0.02). Participants said these conversations included enough details that they felt confident that their family members knew their wishes. Thus, enrollment in a CGMV led to improvements in conversation not only between patient and health care provider but also between family members.

Several themes were identified during discussions. Patients shared personal values and challenges related to advance care planning. Also, the facilitated discussions introduced key advance care planning concepts and encouraged patients to share related experiences, questions, successes, and challenges in regards to these topics. An interesting finding was that patients in groups of 4 or 5 seemed less engaged in the discussion than those in groups of 7 to 9 patients.

Applications for Clinical Practice

This novel strategy to faciliate discussions about advance care planning showed promising results and appears feasible, but further study is needed to evaluate the model. It may prove useful as a new model of advance care planning in primary care. Further longitudinal research is encouraged.

 —Paloma Cesar de Sales, BS, RN, MS

Study Overview

Objective. To examine the effects of acupuncture on vasomotor symptoms (VMS) and quality of life in perimenopausal and postmenopausal women.

Design. Pragmatic randomized controlled trial.

Setting and participants. Participants were perimenopausal and postmenopausal women aged 45 to 60 years who had 4 or more VMS episodes a day. Women were excluded if they had initiated or changed a dose of any VMS treatment in the 4 weeks prior to the study, initiated or changed the dose of an antidepressant in the prior 3 months, had received acupuncture in the prior 4 weeks, self-reported their health as poor or fair, or had a diagnosis of hemophilia. The study was conducted at the Wake Forest School of Medicine and the Chapel Hill Doctors Healthcare Center in North Carolina with women recruited from the community. Potential participants completed a 2-week hot flash diary to establish that they met the eligibility criteria of 4 or more hot flashes a day.

Intervention. Eligible participants were randomized to either the experimental group, who received up to 20 acupuncture treatments over a 6-month period, or a waitlist control group who received usual care for 6 months followed by the same 6 months of acupuncture treatment received by the experimental group. The researchers decided not to use sham acupuncture in the control group because outside of the experiment women would not receive sham acupuncture and because it has been shown to have an effect on menopausal symptoms in other studies.

Participants could receive up to 20 acupuncture treatments from 1 of the 4 study licensed acupuncturists over a period of 6 months. The acupuncturist assessed the participant and made a traditional Chinese medicine diagnosis to guide treatment at the initial and each subsequent visit. During treatment, acupuncture needles were inserted 0.5 to 3 cm through the skin to achieve a “de Qi” sensation, which is a sensation of heaviness, numbness, soreness, or distention at the insertion site. Acupuncturists were permitted to administer additional acupuncture-related treatments with the exception of the use of Chinese herbal remedies. Additionally, participants were permitted to start other treatments, and 11 women in the acupuncture group and 2 women in the control group started other behavioral treatments during the study.

Main outcome measures. The primary outcome measure was the frequency and severity of hot flashes and night sweats, measured using the Daily Diary of Hot Flashes (DDHF). Secondary measures were the following quality of life indicators: hot flash interference (the degree to which hot flashes interfered with specific daily activities), measured using the Hot Flash-related Daily Interference Scale; sleep quality, measured using the Pittsburgh Sleep Quality Index (PSQI) and the PROMIS Sleep Disturbance short form; menopause related symptoms other than VMS, measured using the Women’s Health Questionaire (WHQ); depression, measured using the short form of the Center for Epidemiologic Studies Depression scale (CESD-10); anxiety, measured using the General Anxiety Disorder (GAD-7) and the PROMIS Anxiety short form; perceived stress, measured using the Perceived Stress Scale (PSS); and health-related quality of life (HRQOL), measured using a global visual analog scale (VAS) and the Physical and Mental Health Component scores of the Medical Outcomes Study short form health survey (SF-36).

Main results. The final sample size was 209 women, with 170 randomized to the acupuncture group and 39 to the control group. There were no significant differences between the groups at baseline. The retention rate was 89% at 6 months and 84% at 12 months. At 6 months there was a 36.7% decrease VMS frequency in the acupuncture group compared to a 6.0% increase in the control group (P < 0.001). At 12 months the decrease in VMS frequency was 29.5% in the acupuncture group. The control group began acupuncture at 6 months and by 12 months the frequency of VMS in this group was 31.0% less than at baseline (P < 0.001). Overall, the maximal effect was achieved at week 7 with a median of 8 acupuncture treatments. Sensitivity analysis indicated that there were no differences in effect in those who started other behavioral treatments during this period. There were also significant improvements in scores on the hot flash interference scale (P < 0.001), fewer sleep problems on the sleep measures, and fewer symptoms on the WHQ for women in the acupuncture group and these effects were maintained at 12 months. In addition, similar results were found in the control group after they initiated acupuncture at 6 months.

Conclusion. Overall, acupuncture resulted in significant and sustained improvements in VMS and quality of life measures.

Commentary

More than half of women will experience frequent VMS beginning with the menopause transition [1] and lasting an average of 7.4 years [2]. The effect of VMS on women’s quality of life is considerable, including anxiety, stress, decreased energy, sleep disruption and interference with leisure, social, and work activities [3,4]. Estrogen therapy remains the most effective therapy for VMS; however, its use is contraindicated in many women and duration of use is limited [5]. Therefore, safe and effective alternate therapies are needed.

Acupuncture is a traditional Chinese medicine therapy that has gained popularity in recent years for therapeutic management of many conditions, including pain, nausea related to pregnancy or chemotherapy, anxiety, headache, and addiction. Evidence regarding effectiveness has been equivocal, with studies of its effectiveness in some conditions, such as nausea and dental pain, showing strong positive results while evidence for its use in other conditions is lacking or inconsistent [6]. There have been consistent positive findings in prior research of the use of acupuncture to reduce the severity and frequency of VMS, however, according to the authors of this study, little is known about the long-term effects or the effect on quality of life. Additionally, most studies use sham acupuncture in the control group, which would not be offered to women outside a study protocol and has been shown to have a physiological effect of its own. Therefore, the authors conducted a pragmatic randomized control trial; designing the intervention so that it more closely reflected what happens in a real world clinical setting, to examine the overall effects and effect on quality of life measures.

The results of this study were a significant positive effect of acupuncture on the frequency and severity of VMS in the acupuncture group that was sustained over 12 months and improvements on all quality of life measures. There was also a significant effect in the control group when they received the intervention after the initial 6-month period. As the authors note, it is unclear if improvements in the quality of life indicators were a direct effect of the acupuncture or secondary to the relief of the vasomotor symptoms. Its use in women who experience other menopause-related symptoms, such as mood disorders or sleep disruption, in the absence of VMS needs further study.

The authors compare their results with that of research on the use of selective serotonin reuptake inhibitors (SSRIs) for VMS, one of the more efficacious alternatives to hormone therapy. As they note, though the reduction was somewhat less than that found with SSRIs (for example 35% for acupuncture vs. 47% with escitalopram), the risk of adverse effects is much lower with acupuncture. The only reported adverse effects in this study were 2 women who reported pain during treatment and 1 who reported numbness while SSRIs are known to have significant adverse effects. In addition, the results in this study were sustained longer, until the final follow-up at 6 months, while women who used escitalopram relapsed three weeks after discontinuing the medication.

The use of a pragmatic design allows for more confidence that the findings will translate to the real world setting. The number and timing of acupuncture treatments were determined by each woman with the acupuncturist as would happen in the clinical setting. In addition, the initiation of other therapies during the treatment stage was allowed, with 11 women in the acupuncture group and 2 women in the treatment group starting other behavioral interventions during that time. Though this approach has a small chance of introducing confounding variables, sensitivity analysis indicated it did not. As such, this design results in a study that is an accurate reflection of the experience of women receiving acupuncture in the clinical setting and thus good external validity.

There were 2 limitations of note. Though retention was excellent, 89% and 84% for the acupuncture and control group respectively, it is unknown if the women who dropped out did so due to lack of improvement, in which case the actual reduction in VMS would have been less than reported. Additionally, the use of self-report (diaries) of VMS can be unreliable and biased.

Applications for Clinical Practice

The results of this study indicate that acupuncture offers women a safe and effective therapy for VMS. The optimal dose appears to be 8 treatments. Clinicians should consider it as a first-line treatment for women with moderate to severe VMS who have contraindications to hormone therapy and before prescribing SSRI therapy, which carries the potential for significant adverse effects.

 —Karen Roush, PhD, RN

Study Overview

Objective. To examine the effects of acupuncture on vasomotor symptoms (VMS) and quality of life in perimenopausal and postmenopausal women.

Design. Pragmatic randomized controlled trial.

Setting and participants. Participants were perimenopausal and postmenopausal women aged 45 to 60 years who had 4 or more VMS episodes a day. Women were excluded if they had initiated or changed a dose of any VMS treatment in the 4 weeks prior to the study, initiated or changed the dose of an antidepressant in the prior 3 months, had received acupuncture in the prior 4 weeks, self-reported their health as poor or fair, or had a diagnosis of hemophilia. The study was conducted at the Wake Forest School of Medicine and the Chapel Hill Doctors Healthcare Center in North Carolina with women recruited from the community. Potential participants completed a 2-week hot flash diary to establish that they met the eligibility criteria of 4 or more hot flashes a day.

Intervention. Eligible participants were randomized to either the experimental group, who received up to 20 acupuncture treatments over a 6-month period, or a waitlist control group who received usual care for 6 months followed by the same 6 months of acupuncture treatment received by the experimental group. The researchers decided not to use sham acupuncture in the control group because outside of the experiment women would not receive sham acupuncture and because it has been shown to have an effect on menopausal symptoms in other studies.

Participants could receive up to 20 acupuncture treatments from 1 of the 4 study licensed acupuncturists over a period of 6 months. The acupuncturist assessed the participant and made a traditional Chinese medicine diagnosis to guide treatment at the initial and each subsequent visit. During treatment, acupuncture needles were inserted 0.5 to 3 cm through the skin to achieve a “de Qi” sensation, which is a sensation of heaviness, numbness, soreness, or distention at the insertion site. Acupuncturists were permitted to administer additional acupuncture-related treatments with the exception of the use of Chinese herbal remedies. Additionally, participants were permitted to start other treatments, and 11 women in the acupuncture group and 2 women in the control group started other behavioral treatments during the study.

Main outcome measures. The primary outcome measure was the frequency and severity of hot flashes and night sweats, measured using the Daily Diary of Hot Flashes (DDHF). Secondary measures were the following quality of life indicators: hot flash interference (the degree to which hot flashes interfered with specific daily activities), measured using the Hot Flash-related Daily Interference Scale; sleep quality, measured using the Pittsburgh Sleep Quality Index (PSQI) and the PROMIS Sleep Disturbance short form; menopause related symptoms other than VMS, measured using the Women’s Health Questionaire (WHQ); depression, measured using the short form of the Center for Epidemiologic Studies Depression scale (CESD-10); anxiety, measured using the General Anxiety Disorder (GAD-7) and the PROMIS Anxiety short form; perceived stress, measured using the Perceived Stress Scale (PSS); and health-related quality of life (HRQOL), measured using a global visual analog scale (VAS) and the Physical and Mental Health Component scores of the Medical Outcomes Study short form health survey (SF-36).

Main results. The final sample size was 209 women, with 170 randomized to the acupuncture group and 39 to the control group. There were no significant differences between the groups at baseline. The retention rate was 89% at 6 months and 84% at 12 months. At 6 months there was a 36.7% decrease VMS frequency in the acupuncture group compared to a 6.0% increase in the control group (P < 0.001). At 12 months the decrease in VMS frequency was 29.5% in the acupuncture group. The control group began acupuncture at 6 months and by 12 months the frequency of VMS in this group was 31.0% less than at baseline (P < 0.001). Overall, the maximal effect was achieved at week 7 with a median of 8 acupuncture treatments. Sensitivity analysis indicated that there were no differences in effect in those who started other behavioral treatments during this period. There were also significant improvements in scores on the hot flash interference scale (P < 0.001), fewer sleep problems on the sleep measures, and fewer symptoms on the WHQ for women in the acupuncture group and these effects were maintained at 12 months. In addition, similar results were found in the control group after they initiated acupuncture at 6 months.

Conclusion. Overall, acupuncture resulted in significant and sustained improvements in VMS and quality of life measures.

Commentary

More than half of women will experience frequent VMS beginning with the menopause transition [1] and lasting an average of 7.4 years [2]. The effect of VMS on women’s quality of life is considerable, including anxiety, stress, decreased energy, sleep disruption and interference with leisure, social, and work activities [3,4]. Estrogen therapy remains the most effective therapy for VMS; however, its use is contraindicated in many women and duration of use is limited [5]. Therefore, safe and effective alternate therapies are needed.

Acupuncture is a traditional Chinese medicine therapy that has gained popularity in recent years for therapeutic management of many conditions, including pain, nausea related to pregnancy or chemotherapy, anxiety, headache, and addiction. Evidence regarding effectiveness has been equivocal, with studies of its effectiveness in some conditions, such as nausea and dental pain, showing strong positive results while evidence for its use in other conditions is lacking or inconsistent [6]. There have been consistent positive findings in prior research of the use of acupuncture to reduce the severity and frequency of VMS, however, according to the authors of this study, little is known about the long-term effects or the effect on quality of life. Additionally, most studies use sham acupuncture in the control group, which would not be offered to women outside a study protocol and has been shown to have a physiological effect of its own. Therefore, the authors conducted a pragmatic randomized control trial; designing the intervention so that it more closely reflected what happens in a real world clinical setting, to examine the overall effects and effect on quality of life measures.

The results of this study were a significant positive effect of acupuncture on the frequency and severity of VMS in the acupuncture group that was sustained over 12 months and improvements on all quality of life measures. There was also a significant effect in the control group when they received the intervention after the initial 6-month period. As the authors note, it is unclear if improvements in the quality of life indicators were a direct effect of the acupuncture or secondary to the relief of the vasomotor symptoms. Its use in women who experience other menopause-related symptoms, such as mood disorders or sleep disruption, in the absence of VMS needs further study.

The authors compare their results with that of research on the use of selective serotonin reuptake inhibitors (SSRIs) for VMS, one of the more efficacious alternatives to hormone therapy. As they note, though the reduction was somewhat less than that found with SSRIs (for example 35% for acupuncture vs. 47% with escitalopram), the risk of adverse effects is much lower with acupuncture. The only reported adverse effects in this study were 2 women who reported pain during treatment and 1 who reported numbness while SSRIs are known to have significant adverse effects. In addition, the results in this study were sustained longer, until the final follow-up at 6 months, while women who used escitalopram relapsed three weeks after discontinuing the medication.

The use of a pragmatic design allows for more confidence that the findings will translate to the real world setting. The number and timing of acupuncture treatments were determined by each woman with the acupuncturist as would happen in the clinical setting. In addition, the initiation of other therapies during the treatment stage was allowed, with 11 women in the acupuncture group and 2 women in the treatment group starting other behavioral interventions during that time. Though this approach has a small chance of introducing confounding variables, sensitivity analysis indicated it did not. As such, this design results in a study that is an accurate reflection of the experience of women receiving acupuncture in the clinical setting and thus good external validity.

There were 2 limitations of note. Though retention was excellent, 89% and 84% for the acupuncture and control group respectively, it is unknown if the women who dropped out did so due to lack of improvement, in which case the actual reduction in VMS would have been less than reported. Additionally, the use of self-report (diaries) of VMS can be unreliable and biased.

Applications for Clinical Practice

The results of this study indicate that acupuncture offers women a safe and effective therapy for VMS. The optimal dose appears to be 8 treatments. Clinicians should consider it as a first-line treatment for women with moderate to severe VMS who have contraindications to hormone therapy and before prescribing SSRI therapy, which carries the potential for significant adverse effects.

 —Karen Roush, PhD, RN

Study Overview

Objective. To examine the effects of acupuncture on vasomotor symptoms (VMS) and quality of life in perimenopausal and postmenopausal women.

Design. Pragmatic randomized controlled trial.

Setting and participants. Participants were perimenopausal and postmenopausal women aged 45 to 60 years who had 4 or more VMS episodes a day. Women were excluded if they had initiated or changed a dose of any VMS treatment in the 4 weeks prior to the study, initiated or changed the dose of an antidepressant in the prior 3 months, had received acupuncture in the prior 4 weeks, self-reported their health as poor or fair, or had a diagnosis of hemophilia. The study was conducted at the Wake Forest School of Medicine and the Chapel Hill Doctors Healthcare Center in North Carolina with women recruited from the community. Potential participants completed a 2-week hot flash diary to establish that they met the eligibility criteria of 4 or more hot flashes a day.

Intervention. Eligible participants were randomized to either the experimental group, who received up to 20 acupuncture treatments over a 6-month period, or a waitlist control group who received usual care for 6 months followed by the same 6 months of acupuncture treatment received by the experimental group. The researchers decided not to use sham acupuncture in the control group because outside of the experiment women would not receive sham acupuncture and because it has been shown to have an effect on menopausal symptoms in other studies.

Participants could receive up to 20 acupuncture treatments from 1 of the 4 study licensed acupuncturists over a period of 6 months. The acupuncturist assessed the participant and made a traditional Chinese medicine diagnosis to guide treatment at the initial and each subsequent visit. During treatment, acupuncture needles were inserted 0.5 to 3 cm through the skin to achieve a “de Qi” sensation, which is a sensation of heaviness, numbness, soreness, or distention at the insertion site. Acupuncturists were permitted to administer additional acupuncture-related treatments with the exception of the use of Chinese herbal remedies. Additionally, participants were permitted to start other treatments, and 11 women in the acupuncture group and 2 women in the control group started other behavioral treatments during the study.

Main outcome measures. The primary outcome measure was the frequency and severity of hot flashes and night sweats, measured using the Daily Diary of Hot Flashes (DDHF). Secondary measures were the following quality of life indicators: hot flash interference (the degree to which hot flashes interfered with specific daily activities), measured using the Hot Flash-related Daily Interference Scale; sleep quality, measured using the Pittsburgh Sleep Quality Index (PSQI) and the PROMIS Sleep Disturbance short form; menopause related symptoms other than VMS, measured using the Women’s Health Questionaire (WHQ); depression, measured using the short form of the Center for Epidemiologic Studies Depression scale (CESD-10); anxiety, measured using the General Anxiety Disorder (GAD-7) and the PROMIS Anxiety short form; perceived stress, measured using the Perceived Stress Scale (PSS); and health-related quality of life (HRQOL), measured using a global visual analog scale (VAS) and the Physical and Mental Health Component scores of the Medical Outcomes Study short form health survey (SF-36).

Main results. The final sample size was 209 women, with 170 randomized to the acupuncture group and 39 to the control group. There were no significant differences between the groups at baseline. The retention rate was 89% at 6 months and 84% at 12 months. At 6 months there was a 36.7% decrease VMS frequency in the acupuncture group compared to a 6.0% increase in the control group (P < 0.001). At 12 months the decrease in VMS frequency was 29.5% in the acupuncture group. The control group began acupuncture at 6 months and by 12 months the frequency of VMS in this group was 31.0% less than at baseline (P < 0.001). Overall, the maximal effect was achieved at week 7 with a median of 8 acupuncture treatments. Sensitivity analysis indicated that there were no differences in effect in those who started other behavioral treatments during this period. There were also significant improvements in scores on the hot flash interference scale (P < 0.001), fewer sleep problems on the sleep measures, and fewer symptoms on the WHQ for women in the acupuncture group and these effects were maintained at 12 months. In addition, similar results were found in the control group after they initiated acupuncture at 6 months.

Conclusion. Overall, acupuncture resulted in significant and sustained improvements in VMS and quality of life measures.

Commentary

More than half of women will experience frequent VMS beginning with the menopause transition [1] and lasting an average of 7.4 years [2]. The effect of VMS on women’s quality of life is considerable, including anxiety, stress, decreased energy, sleep disruption and interference with leisure, social, and work activities [3,4]. Estrogen therapy remains the most effective therapy for VMS; however, its use is contraindicated in many women and duration of use is limited [5]. Therefore, safe and effective alternate therapies are needed.

Acupuncture is a traditional Chinese medicine therapy that has gained popularity in recent years for therapeutic management of many conditions, including pain, nausea related to pregnancy or chemotherapy, anxiety, headache, and addiction. Evidence regarding effectiveness has been equivocal, with studies of its effectiveness in some conditions, such as nausea and dental pain, showing strong positive results while evidence for its use in other conditions is lacking or inconsistent [6]. There have been consistent positive findings in prior research of the use of acupuncture to reduce the severity and frequency of VMS, however, according to the authors of this study, little is known about the long-term effects or the effect on quality of life. Additionally, most studies use sham acupuncture in the control group, which would not be offered to women outside a study protocol and has been shown to have a physiological effect of its own. Therefore, the authors conducted a pragmatic randomized control trial; designing the intervention so that it more closely reflected what happens in a real world clinical setting, to examine the overall effects and effect on quality of life measures.

The results of this study were a significant positive effect of acupuncture on the frequency and severity of VMS in the acupuncture group that was sustained over 12 months and improvements on all quality of life measures. There was also a significant effect in the control group when they received the intervention after the initial 6-month period. As the authors note, it is unclear if improvements in the quality of life indicators were a direct effect of the acupuncture or secondary to the relief of the vasomotor symptoms. Its use in women who experience other menopause-related symptoms, such as mood disorders or sleep disruption, in the absence of VMS needs further study.

The authors compare their results with that of research on the use of selective serotonin reuptake inhibitors (SSRIs) for VMS, one of the more efficacious alternatives to hormone therapy. As they note, though the reduction was somewhat less than that found with SSRIs (for example 35% for acupuncture vs. 47% with escitalopram), the risk of adverse effects is much lower with acupuncture. The only reported adverse effects in this study were 2 women who reported pain during treatment and 1 who reported numbness while SSRIs are known to have significant adverse effects. In addition, the results in this study were sustained longer, until the final follow-up at 6 months, while women who used escitalopram relapsed three weeks after discontinuing the medication.

The use of a pragmatic design allows for more confidence that the findings will translate to the real world setting. The number and timing of acupuncture treatments were determined by each woman with the acupuncturist as would happen in the clinical setting. In addition, the initiation of other therapies during the treatment stage was allowed, with 11 women in the acupuncture group and 2 women in the treatment group starting other behavioral interventions during that time. Though this approach has a small chance of introducing confounding variables, sensitivity analysis indicated it did not. As such, this design results in a study that is an accurate reflection of the experience of women receiving acupuncture in the clinical setting and thus good external validity.

There were 2 limitations of note. Though retention was excellent, 89% and 84% for the acupuncture and control group respectively, it is unknown if the women who dropped out did so due to lack of improvement, in which case the actual reduction in VMS would have been less than reported. Additionally, the use of self-report (diaries) of VMS can be unreliable and biased.

Applications for Clinical Practice

The results of this study indicate that acupuncture offers women a safe and effective therapy for VMS. The optimal dose appears to be 8 treatments. Clinicians should consider it as a first-line treatment for women with moderate to severe VMS who have contraindications to hormone therapy and before prescribing SSRI therapy, which carries the potential for significant adverse effects.

 —Karen Roush, PhD, RN

Study Overview

Objective. To determine whether the administration of betamethasone to women who are likely to deliver in the late preterm period would decrease respiratory and other neonatal complications.

Design. Randomized controlled trial.

Setting and participants. Participants were women with a singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation and a high probability of delivery in the late preterm period (which extends to 36 weeks 6 days) within the 17 university-based clinical centers participating in the Maternal Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Eligible women were randomly assigned in a 1:1 ratio to a course of 2 intramuscular injections of either 12 mg betamethasone or matching placebo administered 24 hours apart. After administration of the study medications, the women were treated clinically according to local practice, including discharge to home if delivery did not occur.

Main outcome measures. The primary outcome was a composite endpoint consisting of need for respiratory support, stillbirth, or neonatal death within 72 hours after delivery. Need for respiratory support was defined as one or more of the following: the use of continuous positive airway pressure (CPAP) or high-flow nasal cannula for at least 2 consecutive hours, supplemental oxygen with a fraction of inspired oxygen of at least 0.30 for at least 4 continuous hours, extracorporeal membrane oxygenation (ECMO), or mechanical ventilation. Secondary outcomes included 2 composite outcomes: (1) respiratory distress syndrome, transient tachypnea of the newborn, or apnea; and (2) respiratory distress syndrome, intraventricular hemorrhage, or necrotizing enterocolitis.

Main results. Among 24,133 women assessed for eligibility, 2831 women underwent randomization with 1429 assigned to the betamethasone group and 1402 to the placebo group. A total of 860 (60.2%) in the betamethasone group and 826 (58.9%) in the placebo group received the prespecified 2 doses of study medication. 1083 of the 1145 women (94.6%) who did not receive a second dose delivered before 24 hours. Two women in each study group were lost to follow-up, with outcome information available for 2827 neonates.

The rate of the primary outcome was lower in the betamethasone group (11.6%) than in the placebo group (14.4%), with a relative risk of 0.80% (95% CI 0.66 to 0.97; P = 0.02); the number needed to treat was 35 women to prevent 1 case of the primary outcome. In regard to secondary outcomes, the rate of the composite outcome of severe respiratory complications was also lower in the betamethasone group than in the placebo group (8.1% vs. 12.1%; relative risk 0.67; CI 0.53 to 0.84; P < 0.001). Of note, the betamethasone group had a higher incidence of neonatal hypoglycemia when compared to the placebo group (24.0% vs. 15.0%; relative risk 1.60; 95% CI 1.37 to 1.87; P < 0.001).

Conclusion. Administration of antenatal betamethasone in women at risk for late preterm delivery significantly decreased the rate of respiratory complications in newborns.

Commentary

Use of antenatal glucocorticoids for early preterm delivery has been a widely accepted practice, with strong evidence that glucocorticoids reduce adverse neonatal outcomes when administered to women who are likely to deliver before 34 weeks of gestation [1,2]. In addition, use of glucocorticoids at the time of elective cesarean delivery at term from the results of the Antenatal Steroids for Term Elective Caesarean Section (ASTECS) trial demonstrated reduction in the rate of admission to neonatal intensive care units for respiratory complications in the betamethasone group when comparing to placebo [3]. However, the use of glucocorticoids in the late preterm period to prevent adverse neonatal respiratory outcomes remained inconclusive after 2 smaller randomized trials [4,5].

In the current study, Gyamfi-Bannerman and colleagues addressed the issue of whether the use of glucocorticoids, specifically betamethasone, in the late preterm period may prevent adverse neonatal respiratory outcomes. While only 60.2% of the betamethasone group and 58.9% of the placebo group received the proposed 2 doses of study medication, administration of betamethasone decreased the need for substantial respiratory support during the first 72 hours after birth and other respiratory complications.

There were no clinically significant adverse neonatal effects except that the betamethasone cohort babies had a 60% increased relative risk of neonatal hypoglycemia. There were no reported adverse events related to the hypoglycemia, and infants with hypoglycemia were discharged on average 2 days earlier than those without, which suggests that the condition was self-limiting. The authors suggested monitoring neonatal blood glucose after betamethasone exposure in the late preterm period.  It will be important to answer questions about the long-term outcomes of this therapy, both benefits and risks, such as the potential reduction of chronic lung diseases or risk of developmental delay due to hypoglycemia [6].

Applications for Clinical Practice

This multicenter randomized controlled study provides strong evidence for administering antenatal glucocorticoids, such as betamethasone, in women at risk for late preterm delivery. Betamethasone administration significantly decreased the rate of respiratory complications in newborns, with the precaution to monitor for neonatal hypoglycemia.

 —Ka Ming Gordon Ngai, MD, MPH

Study Overview

Objective. To determine whether the administration of betamethasone to women who are likely to deliver in the late preterm period would decrease respiratory and other neonatal complications.

Design. Randomized controlled trial.

Setting and participants. Participants were women with a singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation and a high probability of delivery in the late preterm period (which extends to 36 weeks 6 days) within the 17 university-based clinical centers participating in the Maternal Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Eligible women were randomly assigned in a 1:1 ratio to a course of 2 intramuscular injections of either 12 mg betamethasone or matching placebo administered 24 hours apart. After administration of the study medications, the women were treated clinically according to local practice, including discharge to home if delivery did not occur.

Main outcome measures. The primary outcome was a composite endpoint consisting of need for respiratory support, stillbirth, or neonatal death within 72 hours after delivery. Need for respiratory support was defined as one or more of the following: the use of continuous positive airway pressure (CPAP) or high-flow nasal cannula for at least 2 consecutive hours, supplemental oxygen with a fraction of inspired oxygen of at least 0.30 for at least 4 continuous hours, extracorporeal membrane oxygenation (ECMO), or mechanical ventilation. Secondary outcomes included 2 composite outcomes: (1) respiratory distress syndrome, transient tachypnea of the newborn, or apnea; and (2) respiratory distress syndrome, intraventricular hemorrhage, or necrotizing enterocolitis.

Main results. Among 24,133 women assessed for eligibility, 2831 women underwent randomization with 1429 assigned to the betamethasone group and 1402 to the placebo group. A total of 860 (60.2%) in the betamethasone group and 826 (58.9%) in the placebo group received the prespecified 2 doses of study medication. 1083 of the 1145 women (94.6%) who did not receive a second dose delivered before 24 hours. Two women in each study group were lost to follow-up, with outcome information available for 2827 neonates.

The rate of the primary outcome was lower in the betamethasone group (11.6%) than in the placebo group (14.4%), with a relative risk of 0.80% (95% CI 0.66 to 0.97; P = 0.02); the number needed to treat was 35 women to prevent 1 case of the primary outcome. In regard to secondary outcomes, the rate of the composite outcome of severe respiratory complications was also lower in the betamethasone group than in the placebo group (8.1% vs. 12.1%; relative risk 0.67; CI 0.53 to 0.84; P < 0.001). Of note, the betamethasone group had a higher incidence of neonatal hypoglycemia when compared to the placebo group (24.0% vs. 15.0%; relative risk 1.60; 95% CI 1.37 to 1.87; P < 0.001).

Conclusion. Administration of antenatal betamethasone in women at risk for late preterm delivery significantly decreased the rate of respiratory complications in newborns.

Commentary

Use of antenatal glucocorticoids for early preterm delivery has been a widely accepted practice, with strong evidence that glucocorticoids reduce adverse neonatal outcomes when administered to women who are likely to deliver before 34 weeks of gestation [1,2]. In addition, use of glucocorticoids at the time of elective cesarean delivery at term from the results of the Antenatal Steroids for Term Elective Caesarean Section (ASTECS) trial demonstrated reduction in the rate of admission to neonatal intensive care units for respiratory complications in the betamethasone group when comparing to placebo [3]. However, the use of glucocorticoids in the late preterm period to prevent adverse neonatal respiratory outcomes remained inconclusive after 2 smaller randomized trials [4,5].

In the current study, Gyamfi-Bannerman and colleagues addressed the issue of whether the use of glucocorticoids, specifically betamethasone, in the late preterm period may prevent adverse neonatal respiratory outcomes. While only 60.2% of the betamethasone group and 58.9% of the placebo group received the proposed 2 doses of study medication, administration of betamethasone decreased the need for substantial respiratory support during the first 72 hours after birth and other respiratory complications.

There were no clinically significant adverse neonatal effects except that the betamethasone cohort babies had a 60% increased relative risk of neonatal hypoglycemia. There were no reported adverse events related to the hypoglycemia, and infants with hypoglycemia were discharged on average 2 days earlier than those without, which suggests that the condition was self-limiting. The authors suggested monitoring neonatal blood glucose after betamethasone exposure in the late preterm period.  It will be important to answer questions about the long-term outcomes of this therapy, both benefits and risks, such as the potential reduction of chronic lung diseases or risk of developmental delay due to hypoglycemia [6].

Applications for Clinical Practice

This multicenter randomized controlled study provides strong evidence for administering antenatal glucocorticoids, such as betamethasone, in women at risk for late preterm delivery. Betamethasone administration significantly decreased the rate of respiratory complications in newborns, with the precaution to monitor for neonatal hypoglycemia.

 —Ka Ming Gordon Ngai, MD, MPH

Study Overview

Objective. To determine whether the administration of betamethasone to women who are likely to deliver in the late preterm period would decrease respiratory and other neonatal complications.

Design. Randomized controlled trial.

Setting and participants. Participants were women with a singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation and a high probability of delivery in the late preterm period (which extends to 36 weeks 6 days) within the 17 university-based clinical centers participating in the Maternal Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Eligible women were randomly assigned in a 1:1 ratio to a course of 2 intramuscular injections of either 12 mg betamethasone or matching placebo administered 24 hours apart. After administration of the study medications, the women were treated clinically according to local practice, including discharge to home if delivery did not occur.

Main outcome measures. The primary outcome was a composite endpoint consisting of need for respiratory support, stillbirth, or neonatal death within 72 hours after delivery. Need for respiratory support was defined as one or more of the following: the use of continuous positive airway pressure (CPAP) or high-flow nasal cannula for at least 2 consecutive hours, supplemental oxygen with a fraction of inspired oxygen of at least 0.30 for at least 4 continuous hours, extracorporeal membrane oxygenation (ECMO), or mechanical ventilation. Secondary outcomes included 2 composite outcomes: (1) respiratory distress syndrome, transient tachypnea of the newborn, or apnea; and (2) respiratory distress syndrome, intraventricular hemorrhage, or necrotizing enterocolitis.

Main results. Among 24,133 women assessed for eligibility, 2831 women underwent randomization with 1429 assigned to the betamethasone group and 1402 to the placebo group. A total of 860 (60.2%) in the betamethasone group and 826 (58.9%) in the placebo group received the prespecified 2 doses of study medication. 1083 of the 1145 women (94.6%) who did not receive a second dose delivered before 24 hours. Two women in each study group were lost to follow-up, with outcome information available for 2827 neonates.

The rate of the primary outcome was lower in the betamethasone group (11.6%) than in the placebo group (14.4%), with a relative risk of 0.80% (95% CI 0.66 to 0.97; P = 0.02); the number needed to treat was 35 women to prevent 1 case of the primary outcome. In regard to secondary outcomes, the rate of the composite outcome of severe respiratory complications was also lower in the betamethasone group than in the placebo group (8.1% vs. 12.1%; relative risk 0.67; CI 0.53 to 0.84; P < 0.001). Of note, the betamethasone group had a higher incidence of neonatal hypoglycemia when compared to the placebo group (24.0% vs. 15.0%; relative risk 1.60; 95% CI 1.37 to 1.87; P < 0.001).

Conclusion. Administration of antenatal betamethasone in women at risk for late preterm delivery significantly decreased the rate of respiratory complications in newborns.

Commentary

Use of antenatal glucocorticoids for early preterm delivery has been a widely accepted practice, with strong evidence that glucocorticoids reduce adverse neonatal outcomes when administered to women who are likely to deliver before 34 weeks of gestation [1,2]. In addition, use of glucocorticoids at the time of elective cesarean delivery at term from the results of the Antenatal Steroids for Term Elective Caesarean Section (ASTECS) trial demonstrated reduction in the rate of admission to neonatal intensive care units for respiratory complications in the betamethasone group when comparing to placebo [3]. However, the use of glucocorticoids in the late preterm period to prevent adverse neonatal respiratory outcomes remained inconclusive after 2 smaller randomized trials [4,5].

In the current study, Gyamfi-Bannerman and colleagues addressed the issue of whether the use of glucocorticoids, specifically betamethasone, in the late preterm period may prevent adverse neonatal respiratory outcomes. While only 60.2% of the betamethasone group and 58.9% of the placebo group received the proposed 2 doses of study medication, administration of betamethasone decreased the need for substantial respiratory support during the first 72 hours after birth and other respiratory complications.

There were no clinically significant adverse neonatal effects except that the betamethasone cohort babies had a 60% increased relative risk of neonatal hypoglycemia. There were no reported adverse events related to the hypoglycemia, and infants with hypoglycemia were discharged on average 2 days earlier than those without, which suggests that the condition was self-limiting. The authors suggested monitoring neonatal blood glucose after betamethasone exposure in the late preterm period.  It will be important to answer questions about the long-term outcomes of this therapy, both benefits and risks, such as the potential reduction of chronic lung diseases or risk of developmental delay due to hypoglycemia [6].

Applications for Clinical Practice

This multicenter randomized controlled study provides strong evidence for administering antenatal glucocorticoids, such as betamethasone, in women at risk for late preterm delivery. Betamethasone administration significantly decreased the rate of respiratory complications in newborns, with the precaution to monitor for neonatal hypoglycemia.

 —Ka Ming Gordon Ngai, MD, MPH

Can’t we just be friends? This is the disquieting question we ask someone when we want to set boundaries. It is meant to define expectation, level of trust and intimacy in a relationship.

We are capable of forming an astonishing variety of relationships with others. We form deep emotional connections with romantic partners, close family, and dear friends. We create more superficial ties with colleagues, distant family, and professionals. Understanding the nature of our relationships is important. There are reasons why professors should not engage in romantic relationships with their students: mixing relationships can lead to confusion and destroy trust. The risk for misunderstanding and harm to one or both parties increases as the intensity of the relationship increases. Can a professor who has a personal relationship with a student be objective? Does the student really want to be kissed or is she feigning interest for a better grade?

The stakes are even higher for us physicians. Forming inappropriate relationships with patients can result in the loss of your medical license. This seems obvious to most of us, but when we examine the appropriateness of other nonprofessional connections, it becomes less clear.

What if you have an intimate but nonsexual relationship with a patient? What about having a family member or close friend as a patient? Most medical ethicists say that any relationship other than the straightforward, professional doctor/patient one is improper. This strict definition exists primarily to protect our patients but also to help us. The highest levels of quality and service can only come from the sterile yet compassionate trust that occurs only in doctor/patient connections.

As a male dermatologist, something as seemingly innocuous as my following a female patient on Instagram puts our professional relationship at risk. If a patient views you as a friend as well as a doctor, would he hesitate to divulge things that are important to his health but inappropriate for a friend to know? Moreover, if I have such knowledge, won’t that impair the trust we share as friends? Such conundrums might hinder your ability to care for your patients and limit the quality of service they receive.

Social media have added many more levels to the already complex ways we can relate to our patients. There are Facebook friends, Snapchat buddies, and Twitter followers. Most of these are diminishingly shallow in terms of the depth and seriousness of the relationship, but they can be misconstrued. In most instances, keep it simple: I’m your doctor. You’re my patient.

When patients ask me to friend them, as they sometime do, I remind them: I’m not your brother or your son. I am not your friend. You pay me to provide a service, yet what I give cannot be bought. I work for you when I’m home. I worry about you when I drive to the office. Someday, I may save your life.

I’m your doctor. No, we cannot be Facebook friends.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and a volunteer clinical assistant professor at the University of California, San Diego. He is @dermdoc on Twitter.

Can’t we just be friends? This is the disquieting question we ask someone when we want to set boundaries. It is meant to define expectation, level of trust and intimacy in a relationship.

We are capable of forming an astonishing variety of relationships with others. We form deep emotional connections with romantic partners, close family, and dear friends. We create more superficial ties with colleagues, distant family, and professionals. Understanding the nature of our relationships is important. There are reasons why professors should not engage in romantic relationships with their students: mixing relationships can lead to confusion and destroy trust. The risk for misunderstanding and harm to one or both parties increases as the intensity of the relationship increases. Can a professor who has a personal relationship with a student be objective? Does the student really want to be kissed or is she feigning interest for a better grade?

The stakes are even higher for us physicians. Forming inappropriate relationships with patients can result in the loss of your medical license. This seems obvious to most of us, but when we examine the appropriateness of other nonprofessional connections, it becomes less clear.

What if you have an intimate but nonsexual relationship with a patient? What about having a family member or close friend as a patient? Most medical ethicists say that any relationship other than the straightforward, professional doctor/patient one is improper. This strict definition exists primarily to protect our patients but also to help us. The highest levels of quality and service can only come from the sterile yet compassionate trust that occurs only in doctor/patient connections.

As a male dermatologist, something as seemingly innocuous as my following a female patient on Instagram puts our professional relationship at risk. If a patient views you as a friend as well as a doctor, would he hesitate to divulge things that are important to his health but inappropriate for a friend to know? Moreover, if I have such knowledge, won’t that impair the trust we share as friends? Such conundrums might hinder your ability to care for your patients and limit the quality of service they receive.

Social media have added many more levels to the already complex ways we can relate to our patients. There are Facebook friends, Snapchat buddies, and Twitter followers. Most of these are diminishingly shallow in terms of the depth and seriousness of the relationship, but they can be misconstrued. In most instances, keep it simple: I’m your doctor. You’re my patient.

When patients ask me to friend them, as they sometime do, I remind them: I’m not your brother or your son. I am not your friend. You pay me to provide a service, yet what I give cannot be bought. I work for you when I’m home. I worry about you when I drive to the office. Someday, I may save your life.

I’m your doctor. No, we cannot be Facebook friends.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and a volunteer clinical assistant professor at the University of California, San Diego. He is @dermdoc on Twitter.

Can’t we just be friends? This is the disquieting question we ask someone when we want to set boundaries. It is meant to define expectation, level of trust and intimacy in a relationship.

We are capable of forming an astonishing variety of relationships with others. We form deep emotional connections with romantic partners, close family, and dear friends. We create more superficial ties with colleagues, distant family, and professionals. Understanding the nature of our relationships is important. There are reasons why professors should not engage in romantic relationships with their students: mixing relationships can lead to confusion and destroy trust. The risk for misunderstanding and harm to one or both parties increases as the intensity of the relationship increases. Can a professor who has a personal relationship with a student be objective? Does the student really want to be kissed or is she feigning interest for a better grade?

The stakes are even higher for us physicians. Forming inappropriate relationships with patients can result in the loss of your medical license. This seems obvious to most of us, but when we examine the appropriateness of other nonprofessional connections, it becomes less clear.

What if you have an intimate but nonsexual relationship with a patient? What about having a family member or close friend as a patient? Most medical ethicists say that any relationship other than the straightforward, professional doctor/patient one is improper. This strict definition exists primarily to protect our patients but also to help us. The highest levels of quality and service can only come from the sterile yet compassionate trust that occurs only in doctor/patient connections.

As a male dermatologist, something as seemingly innocuous as my following a female patient on Instagram puts our professional relationship at risk. If a patient views you as a friend as well as a doctor, would he hesitate to divulge things that are important to his health but inappropriate for a friend to know? Moreover, if I have such knowledge, won’t that impair the trust we share as friends? Such conundrums might hinder your ability to care for your patients and limit the quality of service they receive.

Social media have added many more levels to the already complex ways we can relate to our patients. There are Facebook friends, Snapchat buddies, and Twitter followers. Most of these are diminishingly shallow in terms of the depth and seriousness of the relationship, but they can be misconstrued. In most instances, keep it simple: I’m your doctor. You’re my patient.

When patients ask me to friend them, as they sometime do, I remind them: I’m not your brother or your son. I am not your friend. You pay me to provide a service, yet what I give cannot be bought. I work for you when I’m home. I worry about you when I drive to the office. Someday, I may save your life.

I’m your doctor. No, we cannot be Facebook friends.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and a volunteer clinical assistant professor at the University of California, San Diego. He is @dermdoc on Twitter.

Question: When a doctor could not find a dislodged biopsy guide wire, he abandoned his search after informing the patient of his intention to retrieve it at a later date. Two months later, he was successful in locating and removing the foreign body, but the patient alleged she suffered pain and anxiety in the interim. She filed a negligence lawsuit and, based on the “obvious” nature of her injuries, called no expert witness to testify on her behalf.

Which of the following choices is best?

A. Expert testimony is always needed to establish the applicable standard of care in medical negligence lawsuits.

B. Although a plaintiff is not qualified to expound on medical matters, he/she can offer evidence from learned treatises and medical texts.

C. The jury is the one who determines whether a plaintiff can invoke either the res ipsa loquitur doctrine or the “common knowledge” rule to obviate the need for an expert witness.

D. This patient will likely win her case.

E. All are incorrect.

Answer: E. It is well-established law that the question of negligence must be decided by reference to relevant medical standards of care for which the plaintiff carries the burden of proving through expert medical testimony. Only a professional, duly qualified by the court as an expert witness, is allowed to offer medical testimony – whereas the plaintiff typically will be disqualified from playing this role because of the complexity of issues involved.

However, under either the doctrine of res ipsa loquitur (“the thing speaks for itself”) or the “common knowledge” rule, a court (i.e., the judge) may allow the jury to infer negligence in the absence of expert testimony.

The res doctrine is invoked where there is only circumstantial but no direct evidence, and three conditions are met: 1) The injury would not have occurred in the absence of someone’s negligence; 2) the plaintiff was not at fault; and 3) the defendant had total control of the instrumentality that led to the injury.

The closely related “common knowledge” rule relies on the everyday knowledge and experience of the layperson to identify plain and obvious negligent conduct, which then allows the judge to waive the expert requirement.

The two principles are frequently used interchangeably, ultimately favoring the plaintiff by dispensing with the difficult and expensive task of securing a qualified expert willing to testify against a doctor defendant.

The best example of res in action is the surgeon who inadvertently leaves behind a sponge or instrument inside a body cavity. Other successfully litigated examples include a cardiac arrest in the operating room, hypoxia in the recovery room, burns to the buttock, gangrene after the accidental injection of penicillin into an artery, air trapped subcutaneously from a displaced needle, and a pierced eyeball during a procedure.

A particularly well-known example is Ybarra v. Spangard, in which the patient developed shoulder injuries during an appendectomy.¹ The Supreme Court of California felt it was appropriate to place the burden on the operating room defendants to explain how the patient, unconscious under general anesthesia throughout the procedure, sustained the shoulder injury.

The scenario provided in the opening question is taken from a 2013 New York case, James v. Wormuth, in which the plaintiff relied on the res doctrine.² The defendant doctor had left a guide wire in the plaintiff’s chest following a biopsy and was unable to locate it after a 20-minute search. However, he was able to retrieve the wire 2 months later under C-arm imaging.

The plaintiff sued the doctor for pain and anxiety, but did not call any expert witness, relying instead on the “foreign object” basis for invoking the res doctrine. The lower court ruled for the doctor, and the court of appeals affirmed.

It reasoned that the object was left behind deliberately, not unintentionally, and that under the circumstances of the case, an expert witness was needed to set out the applicable standard of care, without which a jury could not determine whether the doctor’s professional judgment breached the requisite standard. The court also ruled that the plaintiff failed to satisfy the “exclusive control” requirement of the res doctrine, because several other individuals participated to an extent in the medical procedure.

Hawaii’s case of Barbee v. Queen’s Medical Center is illustrative of the “common knowledge” rule.³ Mr. Barbee, age 75 years, underwent laparoscopic nephrectomy for a malignancy. Massive bleeding complicated his postoperative course, the hemoglobin falling into the 3 range, and he required emergent reoperation. Over the next 18 months, the patient progressively deteriorated, eventually requiring dialysis and dying from a stroke and intestinal volvulus.

Notwithstanding an initial jury verdict in favor of the plaintiff’s children, awarding each of the three children $365,000, the defendants filed a so-called JNOV motion (current term is “judgment as a matter of law”) to negate the jury verdict, on the basis that the plaintiffs failed to present competent expert testimony at trial to prove causation.

The plaintiffs countered that the cause of death was within the realm of common knowledge, thus no expert was necessary. They asserted that “any lay person can easily grasp the concept that a person dies from losing so much blood that multiple organs fail to perform their functions.” Mr. Barbee’s death thus was not “of such a technical nature that lay persons are incompetent to draw their own conclusions from facts presented without aid.”

Hawaii’s Intermediate Court of Appeals disagreed with the plaintiffs, holding that although “Hawaii does recognize a ‘common knowledge’ exception to the requirement that a plaintiff must introduce expert medical testimony on causation … this exception is rare in application.” The court asserted that the causal link between any alleged negligence and Mr. Barbee’s death 17 months later is not within the realm of common knowledge.

It reasoned that the long-term effects of internal bleeding are not so widely known as to be analogous to leaving a sponge within a patient or removing the wrong limb during an amputation. Moreover, Mr. Barbee had a long history of preexisting conditions, including hypertension, diabetes, and cancer. He also suffered numerous and serious postoperative medical conditions, including a stroke and surgery to remove part of his intestine, which had become gangrenous.

Thus, the role that preexisting conditions and/or the subsequent complications of this type played in Mr. Barbee’s death was not within the knowledge of the average layperson.

The “common knowledge” rule is aligned with, though not identical to, the res doctrine, but courts are known to conflate the two legal principles, often using them interchangeably.⁴

Strictly speaking, the “common knowledge” waiver comes into play where direct evidence of negligent conduct lies within the realm of everyday lay knowledge that the physician had deviated from common practice. It may or may not address the causation issue.

On the other hand, res is successfully invoked when, despite no direct evidence of negligence and causation, the circumstances surrounding the injury are such that the plaintiff’s case can go to the jury without expert testimony.

References

1. Ybarra v. Spangard, 154 P.2d 687 (Cal. 1944).

2. James v. Wormuth, 997 N.E.2d 133 (N.Y. 2013).

3. Barbee v. Queen’s Medical Center, 119 Haw 136 (2008).

4. Spinner, Amanda E. Common Ignorance: Medical Malpractice Law and the Misconceived Application of the “Common Knowledge” and “Res Ipsa Loquitur” Doctrines.” Touro Law Review: Vol. 31: No. 3, Article 15. Available at http://digitalcommons.tourolaw.edu/lawreview/vol31/iss3/15.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: When a doctor could not find a dislodged biopsy guide wire, he abandoned his search after informing the patient of his intention to retrieve it at a later date. Two months later, he was successful in locating and removing the foreign body, but the patient alleged she suffered pain and anxiety in the interim. She filed a negligence lawsuit and, based on the “obvious” nature of her injuries, called no expert witness to testify on her behalf.

Which of the following choices is best?

A. Expert testimony is always needed to establish the applicable standard of care in medical negligence lawsuits.

B. Although a plaintiff is not qualified to expound on medical matters, he/she can offer evidence from learned treatises and medical texts.

C. The jury is the one who determines whether a plaintiff can invoke either the res ipsa loquitur doctrine or the “common knowledge” rule to obviate the need for an expert witness.

D. This patient will likely win her case.

E. All are incorrect.

Answer: E. It is well-established law that the question of negligence must be decided by reference to relevant medical standards of care for which the plaintiff carries the burden of proving through expert medical testimony. Only a professional, duly qualified by the court as an expert witness, is allowed to offer medical testimony – whereas the plaintiff typically will be disqualified from playing this role because of the complexity of issues involved.

However, under either the doctrine of res ipsa loquitur (“the thing speaks for itself”) or the “common knowledge” rule, a court (i.e., the judge) may allow the jury to infer negligence in the absence of expert testimony.

The res doctrine is invoked where there is only circumstantial but no direct evidence, and three conditions are met: 1) The injury would not have occurred in the absence of someone’s negligence; 2) the plaintiff was not at fault; and 3) the defendant had total control of the instrumentality that led to the injury.

The closely related “common knowledge” rule relies on the everyday knowledge and experience of the layperson to identify plain and obvious negligent conduct, which then allows the judge to waive the expert requirement.

The two principles are frequently used interchangeably, ultimately favoring the plaintiff by dispensing with the difficult and expensive task of securing a qualified expert willing to testify against a doctor defendant.

The best example of res in action is the surgeon who inadvertently leaves behind a sponge or instrument inside a body cavity. Other successfully litigated examples include a cardiac arrest in the operating room, hypoxia in the recovery room, burns to the buttock, gangrene after the accidental injection of penicillin into an artery, air trapped subcutaneously from a displaced needle, and a pierced eyeball during a procedure.

A particularly well-known example is Ybarra v. Spangard, in which the patient developed shoulder injuries during an appendectomy.¹ The Supreme Court of California felt it was appropriate to place the burden on the operating room defendants to explain how the patient, unconscious under general anesthesia throughout the procedure, sustained the shoulder injury.

The scenario provided in the opening question is taken from a 2013 New York case, James v. Wormuth, in which the plaintiff relied on the res doctrine.² The defendant doctor had left a guide wire in the plaintiff’s chest following a biopsy and was unable to locate it after a 20-minute search. However, he was able to retrieve the wire 2 months later under C-arm imaging.

The plaintiff sued the doctor for pain and anxiety, but did not call any expert witness, relying instead on the “foreign object” basis for invoking the res doctrine. The lower court ruled for the doctor, and the court of appeals affirmed.

It reasoned that the object was left behind deliberately, not unintentionally, and that under the circumstances of the case, an expert witness was needed to set out the applicable standard of care, without which a jury could not determine whether the doctor’s professional judgment breached the requisite standard. The court also ruled that the plaintiff failed to satisfy the “exclusive control” requirement of the res doctrine, because several other individuals participated to an extent in the medical procedure.

Hawaii’s case of Barbee v. Queen’s Medical Center is illustrative of the “common knowledge” rule.³ Mr. Barbee, age 75 years, underwent laparoscopic nephrectomy for a malignancy. Massive bleeding complicated his postoperative course, the hemoglobin falling into the 3 range, and he required emergent reoperation. Over the next 18 months, the patient progressively deteriorated, eventually requiring dialysis and dying from a stroke and intestinal volvulus.

Notwithstanding an initial jury verdict in favor of the plaintiff’s children, awarding each of the three children $365,000, the defendants filed a so-called JNOV motion (current term is “judgment as a matter of law”) to negate the jury verdict, on the basis that the plaintiffs failed to present competent expert testimony at trial to prove causation.

The plaintiffs countered that the cause of death was within the realm of common knowledge, thus no expert was necessary. They asserted that “any lay person can easily grasp the concept that a person dies from losing so much blood that multiple organs fail to perform their functions.” Mr. Barbee’s death thus was not “of such a technical nature that lay persons are incompetent to draw their own conclusions from facts presented without aid.”

Hawaii’s Intermediate Court of Appeals disagreed with the plaintiffs, holding that although “Hawaii does recognize a ‘common knowledge’ exception to the requirement that a plaintiff must introduce expert medical testimony on causation … this exception is rare in application.” The court asserted that the causal link between any alleged negligence and Mr. Barbee’s death 17 months later is not within the realm of common knowledge.

It reasoned that the long-term effects of internal bleeding are not so widely known as to be analogous to leaving a sponge within a patient or removing the wrong limb during an amputation. Moreover, Mr. Barbee had a long history of preexisting conditions, including hypertension, diabetes, and cancer. He also suffered numerous and serious postoperative medical conditions, including a stroke and surgery to remove part of his intestine, which had become gangrenous.

Thus, the role that preexisting conditions and/or the subsequent complications of this type played in Mr. Barbee’s death was not within the knowledge of the average layperson.

The “common knowledge” rule is aligned with, though not identical to, the res doctrine, but courts are known to conflate the two legal principles, often using them interchangeably.⁴

Strictly speaking, the “common knowledge” waiver comes into play where direct evidence of negligent conduct lies within the realm of everyday lay knowledge that the physician had deviated from common practice. It may or may not address the causation issue.

On the other hand, res is successfully invoked when, despite no direct evidence of negligence and causation, the circumstances surrounding the injury are such that the plaintiff’s case can go to the jury without expert testimony.

References

1. Ybarra v. Spangard, 154 P.2d 687 (Cal. 1944).

2. James v. Wormuth, 997 N.E.2d 133 (N.Y. 2013).

3. Barbee v. Queen’s Medical Center, 119 Haw 136 (2008).

4. Spinner, Amanda E. Common Ignorance: Medical Malpractice Law and the Misconceived Application of the “Common Knowledge” and “Res Ipsa Loquitur” Doctrines.” Touro Law Review: Vol. 31: No. 3, Article 15. Available at http://digitalcommons.tourolaw.edu/lawreview/vol31/iss3/15.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: When a doctor could not find a dislodged biopsy guide wire, he abandoned his search after informing the patient of his intention to retrieve it at a later date. Two months later, he was successful in locating and removing the foreign body, but the patient alleged she suffered pain and anxiety in the interim. She filed a negligence lawsuit and, based on the “obvious” nature of her injuries, called no expert witness to testify on her behalf.

Which of the following choices is best?

A. Expert testimony is always needed to establish the applicable standard of care in medical negligence lawsuits.

B. Although a plaintiff is not qualified to expound on medical matters, he/she can offer evidence from learned treatises and medical texts.

C. The jury is the one who determines whether a plaintiff can invoke either the res ipsa loquitur doctrine or the “common knowledge” rule to obviate the need for an expert witness.

D. This patient will likely win her case.

E. All are incorrect.

Answer: E. It is well-established law that the question of negligence must be decided by reference to relevant medical standards of care for which the plaintiff carries the burden of proving through expert medical testimony. Only a professional, duly qualified by the court as an expert witness, is allowed to offer medical testimony – whereas the plaintiff typically will be disqualified from playing this role because of the complexity of issues involved.

However, under either the doctrine of res ipsa loquitur (“the thing speaks for itself”) or the “common knowledge” rule, a court (i.e., the judge) may allow the jury to infer negligence in the absence of expert testimony.

The res doctrine is invoked where there is only circumstantial but no direct evidence, and three conditions are met: 1) The injury would not have occurred in the absence of someone’s negligence; 2) the plaintiff was not at fault; and 3) the defendant had total control of the instrumentality that led to the injury.

The closely related “common knowledge” rule relies on the everyday knowledge and experience of the layperson to identify plain and obvious negligent conduct, which then allows the judge to waive the expert requirement.

The two principles are frequently used interchangeably, ultimately favoring the plaintiff by dispensing with the difficult and expensive task of securing a qualified expert willing to testify against a doctor defendant.

The best example of res in action is the surgeon who inadvertently leaves behind a sponge or instrument inside a body cavity. Other successfully litigated examples include a cardiac arrest in the operating room, hypoxia in the recovery room, burns to the buttock, gangrene after the accidental injection of penicillin into an artery, air trapped subcutaneously from a displaced needle, and a pierced eyeball during a procedure.

A particularly well-known example is Ybarra v. Spangard, in which the patient developed shoulder injuries during an appendectomy.¹ The Supreme Court of California felt it was appropriate to place the burden on the operating room defendants to explain how the patient, unconscious under general anesthesia throughout the procedure, sustained the shoulder injury.

The scenario provided in the opening question is taken from a 2013 New York case, James v. Wormuth, in which the plaintiff relied on the res doctrine.² The defendant doctor had left a guide wire in the plaintiff’s chest following a biopsy and was unable to locate it after a 20-minute search. However, he was able to retrieve the wire 2 months later under C-arm imaging.

The plaintiff sued the doctor for pain and anxiety, but did not call any expert witness, relying instead on the “foreign object” basis for invoking the res doctrine. The lower court ruled for the doctor, and the court of appeals affirmed.

It reasoned that the object was left behind deliberately, not unintentionally, and that under the circumstances of the case, an expert witness was needed to set out the applicable standard of care, without which a jury could not determine whether the doctor’s professional judgment breached the requisite standard. The court also ruled that the plaintiff failed to satisfy the “exclusive control” requirement of the res doctrine, because several other individuals participated to an extent in the medical procedure.

Hawaii’s case of Barbee v. Queen’s Medical Center is illustrative of the “common knowledge” rule.³ Mr. Barbee, age 75 years, underwent laparoscopic nephrectomy for a malignancy. Massive bleeding complicated his postoperative course, the hemoglobin falling into the 3 range, and he required emergent reoperation. Over the next 18 months, the patient progressively deteriorated, eventually requiring dialysis and dying from a stroke and intestinal volvulus.

Notwithstanding an initial jury verdict in favor of the plaintiff’s children, awarding each of the three children $365,000, the defendants filed a so-called JNOV motion (current term is “judgment as a matter of law”) to negate the jury verdict, on the basis that the plaintiffs failed to present competent expert testimony at trial to prove causation.

The plaintiffs countered that the cause of death was within the realm of common knowledge, thus no expert was necessary. They asserted that “any lay person can easily grasp the concept that a person dies from losing so much blood that multiple organs fail to perform their functions.” Mr. Barbee’s death thus was not “of such a technical nature that lay persons are incompetent to draw their own conclusions from facts presented without aid.”

Hawaii’s Intermediate Court of Appeals disagreed with the plaintiffs, holding that although “Hawaii does recognize a ‘common knowledge’ exception to the requirement that a plaintiff must introduce expert medical testimony on causation … this exception is rare in application.” The court asserted that the causal link between any alleged negligence and Mr. Barbee’s death 17 months later is not within the realm of common knowledge.

It reasoned that the long-term effects of internal bleeding are not so widely known as to be analogous to leaving a sponge within a patient or removing the wrong limb during an amputation. Moreover, Mr. Barbee had a long history of preexisting conditions, including hypertension, diabetes, and cancer. He also suffered numerous and serious postoperative medical conditions, including a stroke and surgery to remove part of his intestine, which had become gangrenous.

Thus, the role that preexisting conditions and/or the subsequent complications of this type played in Mr. Barbee’s death was not within the knowledge of the average layperson.

The “common knowledge” rule is aligned with, though not identical to, the res doctrine, but courts are known to conflate the two legal principles, often using them interchangeably.⁴

Strictly speaking, the “common knowledge” waiver comes into play where direct evidence of negligent conduct lies within the realm of everyday lay knowledge that the physician had deviated from common practice. It may or may not address the causation issue.

On the other hand, res is successfully invoked when, despite no direct evidence of negligence and causation, the circumstances surrounding the injury are such that the plaintiff’s case can go to the jury without expert testimony.

References

1. Ybarra v. Spangard, 154 P.2d 687 (Cal. 1944).

2. James v. Wormuth, 997 N.E.2d 133 (N.Y. 2013).

3. Barbee v. Queen’s Medical Center, 119 Haw 136 (2008).

4. Spinner, Amanda E. Common Ignorance: Medical Malpractice Law and the Misconceived Application of the “Common Knowledge” and “Res Ipsa Loquitur” Doctrines.” Touro Law Review: Vol. 31: No. 3, Article 15. Available at http://digitalcommons.tourolaw.edu/lawreview/vol31/iss3/15.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Monoclonal antibodies

Photo by Linda Bartlett

NEW ORLEANS—A small study suggests that treatment with lenalidomide and dexamethasone (len-dex) prompts an increase in cancer stem cells (CSCs) for patients with newly diagnosed multiple myeloma (MM).

However, adding an anti-CD19 monoclonal antibody (mAb) to the regimen can reduce CSCs.

Most patients who received the mAb, MEDI-551, experienced a decrease in CSCs, but the cells rebounded after the patients stopped receiving  MEDI-551.

And those patients who did not see a decrease in CSCs progressed. However, some patients are still in response and remain on treatment with len-dex.

The investigators believe these early results suggest prolonged treatment with len-dex and MED-551 may be safe and clinically beneficial for MM patients.

The results were presented at the 2016 AACR Annual Meeting (abstract CT102).

The study included 17 patients with newly diagnosed MM. They had a median age of 65 (range, 34-73). Most had ISS stage I (n=11), 2 had stage II, and 4 had stage III. Seven patients had t(4;14).

“We chose to carry out this clinical trial in newly diagnosed patients because our original data showed that CD19 was almost always expressed by myeloma stem cells in these patients, whereas we don’t know if that is the case in more advanced patients,” said investigator William Matsui, MD, of Johns Hopkins University School of Medicine in Baltimore, Maryland.

The patients received 28-day cycles of len-dex (len at 25 mg PO, days 1-21, and dex at 40 mg PO, weekly). Patients received MEDI-551 (at 4 mg/kg IV) in cycle 3 (day 1, 8) and cycle 4 (day 1). Responding patients continued on len-dex.

The investigators measured MM CSCs by quantifying the growth of MM colonies (CFU-MM) from marrow aspirates at baseline and at the end of cycles 2 and 4.

The team quantified peripheral blood CSCs by flow cytometry (CD19+CD27+ALDH+) at baseline and the end of cycles 2, 4, 5, and 7.

“We wanted to see if these 2 assays gave similar results, and, in this clinical trial, they were almost identical,” said investigator Carol Ann Huff, MD, also of Johns Hopkins.

“Since it is much easier to draw blood than bone marrow from our patients, we think that we can primarily use blood to track multiple myeloma stem cells in the future.”

Response

Two patients did not receive MEDI-551 due to progressive disease and noncompliance. So the investigators assessed responses in 15 patients.

After cycle 2 (len-dex alone), there were 3 very good partial responses (VGPRs), 10 partial responses (PRs), 1 molecular response, and 1 case of stable disease.

After cycle 4 (len-dex plus MEDI-551), there were 6 VGPRs, 8 PRs, and 1 molecular response.

Ten patients who completed treatment with MED-551 remain on len-dex. At the end of cycle 7, there was 1 complete response, 8 VGPRs, and 1 PR.

CFU-MM

When compared to baseline, bone-marrow-derived CFU-MM increased a median of 2.5-fold (range, 0.4-7.4) after cycle 2 but decreased a median of 0.48-fold (range, 0.14-0.85) in 14 patients after cycle 4.

The investigators compared these results to 5 newly diagnosed MM patients who only received standard treatment with len-dex.

In these patients, CFU-MM increased a median of 9.3-fold (range, 4-14) at a median of 4 months (range, 2-4). This is in spite of the fact that all of these patients had a PR or better.

Circulating CSCs

Compared to baseline, circulating MM CSCs increased a median of 1.6-fold (range, 0.4-8.6) in 14 patients after cycle 2 but decreased a median of 0.6-fold (range, 0.01-7.4) in 13 patients after cycle 4.

At the end of cycle 5, MM CSCs had increased in 4 of the 10 patients who were still on len-dex. By the end of cycle 7, MM CSCs had increased in 8 of the patients.

Circulating MM CSCs increased by the end of cycle 4 in 2 patients, and both had progressed by end of cycle 7.

Safety and next steps

The investigators said there were no serious adverse events in this trial, but 2 patients experienced grade 2 infusion reactions after the first MEDI-551 dose.

The team plans to conduct further studies to assess the long-term impact of MED-551 in MM patients and determine how the mAb might work in combination with other treatments, particularly transplant.

“In other studies at Johns Hopkins, we have found that antibody therapies can work much better after a bone marrow transplant, especially allogeneic transplants,” Dr Matsui said.

Funding and drugs for this study were provided by MedImmune Inc., the developers of MEDI-551. Drs Huff and Matsui served as a paid scientific advisory board member and a consultant to MedImmune Inc., respectively.

Monoclonal antibodies

Photo by Linda Bartlett

NEW ORLEANS—A small study suggests that treatment with lenalidomide and dexamethasone (len-dex) prompts an increase in cancer stem cells (CSCs) for patients with newly diagnosed multiple myeloma (MM).

However, adding an anti-CD19 monoclonal antibody (mAb) to the regimen can reduce CSCs.

Most patients who received the mAb, MEDI-551, experienced a decrease in CSCs, but the cells rebounded after the patients stopped receiving  MEDI-551.

And those patients who did not see a decrease in CSCs progressed. However, some patients are still in response and remain on treatment with len-dex.

The investigators believe these early results suggest prolonged treatment with len-dex and MED-551 may be safe and clinically beneficial for MM patients.

The results were presented at the 2016 AACR Annual Meeting (abstract CT102).

The study included 17 patients with newly diagnosed MM. They had a median age of 65 (range, 34-73). Most had ISS stage I (n=11), 2 had stage II, and 4 had stage III. Seven patients had t(4;14).

“We chose to carry out this clinical trial in newly diagnosed patients because our original data showed that CD19 was almost always expressed by myeloma stem cells in these patients, whereas we don’t know if that is the case in more advanced patients,” said investigator William Matsui, MD, of Johns Hopkins University School of Medicine in Baltimore, Maryland.

The patients received 28-day cycles of len-dex (len at 25 mg PO, days 1-21, and dex at 40 mg PO, weekly). Patients received MEDI-551 (at 4 mg/kg IV) in cycle 3 (day 1, 8) and cycle 4 (day 1). Responding patients continued on len-dex.

The investigators measured MM CSCs by quantifying the growth of MM colonies (CFU-MM) from marrow aspirates at baseline and at the end of cycles 2 and 4.

The team quantified peripheral blood CSCs by flow cytometry (CD19+CD27+ALDH+) at baseline and the end of cycles 2, 4, 5, and 7.

“We wanted to see if these 2 assays gave similar results, and, in this clinical trial, they were almost identical,” said investigator Carol Ann Huff, MD, also of Johns Hopkins.

“Since it is much easier to draw blood than bone marrow from our patients, we think that we can primarily use blood to track multiple myeloma stem cells in the future.”

Response

Two patients did not receive MEDI-551 due to progressive disease and noncompliance. So the investigators assessed responses in 15 patients.

After cycle 2 (len-dex alone), there were 3 very good partial responses (VGPRs), 10 partial responses (PRs), 1 molecular response, and 1 case of stable disease.

After cycle 4 (len-dex plus MEDI-551), there were 6 VGPRs, 8 PRs, and 1 molecular response.

Ten patients who completed treatment with MED-551 remain on len-dex. At the end of cycle 7, there was 1 complete response, 8 VGPRs, and 1 PR.

CFU-MM

When compared to baseline, bone-marrow-derived CFU-MM increased a median of 2.5-fold (range, 0.4-7.4) after cycle 2 but decreased a median of 0.48-fold (range, 0.14-0.85) in 14 patients after cycle 4.

The investigators compared these results to 5 newly diagnosed MM patients who only received standard treatment with len-dex.

In these patients, CFU-MM increased a median of 9.3-fold (range, 4-14) at a median of 4 months (range, 2-4). This is in spite of the fact that all of these patients had a PR or better.

Circulating CSCs

Compared to baseline, circulating MM CSCs increased a median of 1.6-fold (range, 0.4-8.6) in 14 patients after cycle 2 but decreased a median of 0.6-fold (range, 0.01-7.4) in 13 patients after cycle 4.

At the end of cycle 5, MM CSCs had increased in 4 of the 10 patients who were still on len-dex. By the end of cycle 7, MM CSCs had increased in 8 of the patients.

Circulating MM CSCs increased by the end of cycle 4 in 2 patients, and both had progressed by end of cycle 7.

Safety and next steps

The investigators said there were no serious adverse events in this trial, but 2 patients experienced grade 2 infusion reactions after the first MEDI-551 dose.

The team plans to conduct further studies to assess the long-term impact of MED-551 in MM patients and determine how the mAb might work in combination with other treatments, particularly transplant.

“In other studies at Johns Hopkins, we have found that antibody therapies can work much better after a bone marrow transplant, especially allogeneic transplants,” Dr Matsui said.

Funding and drugs for this study were provided by MedImmune Inc., the developers of MEDI-551. Drs Huff and Matsui served as a paid scientific advisory board member and a consultant to MedImmune Inc., respectively.

Monoclonal antibodies

Photo by Linda Bartlett

NEW ORLEANS—A small study suggests that treatment with lenalidomide and dexamethasone (len-dex) prompts an increase in cancer stem cells (CSCs) for patients with newly diagnosed multiple myeloma (MM).

However, adding an anti-CD19 monoclonal antibody (mAb) to the regimen can reduce CSCs.

Most patients who received the mAb, MEDI-551, experienced a decrease in CSCs, but the cells rebounded after the patients stopped receiving  MEDI-551.

And those patients who did not see a decrease in CSCs progressed. However, some patients are still in response and remain on treatment with len-dex.

The investigators believe these early results suggest prolonged treatment with len-dex and MED-551 may be safe and clinically beneficial for MM patients.

The results were presented at the 2016 AACR Annual Meeting (abstract CT102).

The study included 17 patients with newly diagnosed MM. They had a median age of 65 (range, 34-73). Most had ISS stage I (n=11), 2 had stage II, and 4 had stage III. Seven patients had t(4;14).

“We chose to carry out this clinical trial in newly diagnosed patients because our original data showed that CD19 was almost always expressed by myeloma stem cells in these patients, whereas we don’t know if that is the case in more advanced patients,” said investigator William Matsui, MD, of Johns Hopkins University School of Medicine in Baltimore, Maryland.

The patients received 28-day cycles of len-dex (len at 25 mg PO, days 1-21, and dex at 40 mg PO, weekly). Patients received MEDI-551 (at 4 mg/kg IV) in cycle 3 (day 1, 8) and cycle 4 (day 1). Responding patients continued on len-dex.

The investigators measured MM CSCs by quantifying the growth of MM colonies (CFU-MM) from marrow aspirates at baseline and at the end of cycles 2 and 4.

The team quantified peripheral blood CSCs by flow cytometry (CD19+CD27+ALDH+) at baseline and the end of cycles 2, 4, 5, and 7.

“We wanted to see if these 2 assays gave similar results, and, in this clinical trial, they were almost identical,” said investigator Carol Ann Huff, MD, also of Johns Hopkins.

“Since it is much easier to draw blood than bone marrow from our patients, we think that we can primarily use blood to track multiple myeloma stem cells in the future.”

Response

Two patients did not receive MEDI-551 due to progressive disease and noncompliance. So the investigators assessed responses in 15 patients.

After cycle 2 (len-dex alone), there were 3 very good partial responses (VGPRs), 10 partial responses (PRs), 1 molecular response, and 1 case of stable disease.

After cycle 4 (len-dex plus MEDI-551), there were 6 VGPRs, 8 PRs, and 1 molecular response.

Ten patients who completed treatment with MED-551 remain on len-dex. At the end of cycle 7, there was 1 complete response, 8 VGPRs, and 1 PR.

CFU-MM

When compared to baseline, bone-marrow-derived CFU-MM increased a median of 2.5-fold (range, 0.4-7.4) after cycle 2 but decreased a median of 0.48-fold (range, 0.14-0.85) in 14 patients after cycle 4.

The investigators compared these results to 5 newly diagnosed MM patients who only received standard treatment with len-dex.

In these patients, CFU-MM increased a median of 9.3-fold (range, 4-14) at a median of 4 months (range, 2-4). This is in spite of the fact that all of these patients had a PR or better.

Circulating CSCs

Compared to baseline, circulating MM CSCs increased a median of 1.6-fold (range, 0.4-8.6) in 14 patients after cycle 2 but decreased a median of 0.6-fold (range, 0.01-7.4) in 13 patients after cycle 4.

At the end of cycle 5, MM CSCs had increased in 4 of the 10 patients who were still on len-dex. By the end of cycle 7, MM CSCs had increased in 8 of the patients.

Circulating MM CSCs increased by the end of cycle 4 in 2 patients, and both had progressed by end of cycle 7.

Safety and next steps

The investigators said there were no serious adverse events in this trial, but 2 patients experienced grade 2 infusion reactions after the first MEDI-551 dose.

The team plans to conduct further studies to assess the long-term impact of MED-551 in MM patients and determine how the mAb might work in combination with other treatments, particularly transplant.

“In other studies at Johns Hopkins, we have found that antibody therapies can work much better after a bone marrow transplant, especially allogeneic transplants,” Dr Matsui said.

Funding and drugs for this study were provided by MedImmune Inc., the developers of MEDI-551. Drs Huff and Matsui served as a paid scientific advisory board member and a consultant to MedImmune Inc., respectively.

Now with 15,000 members and growing, SHM continues to change the face of medicine—one patient at a time. We recently spoke with Dr. Glauber about her path to hospital medicine and why she believes in its continued growth and success during these times of unprecedented change.

Question: What steered you toward a career in hospital medicine?

Answer: Believe it or not, I did not enter medical school at New York Medical College with dreams of becoming a hospitalist. I first became aware of hospital medicine as a career path during my internal medicine residency at Loyola University School of Medicine in Maywood, Ill. I had some great hospitalist mentors during residency who clearly enjoyed their careers.

As I completed my training, hospital medicine was the clear choice for me. I wanted to manage patients with a variety of diagnoses and wasn’t ready to limit myself to any one subspecialty. I had always found diagnosis and management of acutely ill hospitalized patients to be the most interesting part of medicine, and I thoroughly enjoy working in the hospital environment. The field of hospital medicine was rapidly evolving, and I was curious to see where I could go with it. After four years, I can say with confidence that it has been a great experience.

Q: What do you see as the most rewarding part of your job?

A: Although my experiences practicing hospital medicine have been rewarding in a variety of ways, in the end, it’s pretty simple: I get satisfaction from helping my patients heal and helping them through the experience of hospitalization. It may take days, or it may take months to accomplish, and it is often the result of a cumulative effort of numerous hospitalists, consultants, and the entire hospital staff. But the reward for me is seeing my patient sitting in a chair, dressed in their street clothes, and waiting for their ride to come pick them up.

Q: Why do you think hospital medicine is the fastest-growing specialty in medicine? How can this momentum be sustained moving forward?

A: The growth of hospital medicine reflects the changing landscape of medicine nationwide. Hospitalist jobs are available because hospitals recognize the benefits of having us on hand to provide efficient and quality care to the patients. In terms of career choices, it is appealing to those coming straight out of residency, more experienced physicians practicing outpatient medicine, and even subspecialists who are looking for a career change. It is a satisfying and interesting job, which by nature benefits from unconventional work schedules. I think this flexibility is a big draw as well, in addition to the rewarding career.

Q: Why were you intrigued to join SHM and also attend Hospital Medicine 2016 (HM16)?

A: I think joining SHM is probably long overdue! I have been practicing for four years and feel that it’s time to take stock of my strengths and weaknesses as a hospitalist and try to improve. Through SHM, I can stay up to date on relevant medical topics, including everything from antibiotic resistance to glycemic control, as well as learn how to be a better hospitalist through the experience and research of colleagues. Attending HM16 seemed like a great way to get started, learn some new things, and network with hospitalists around the country.

Q: As a new member to SHM, what do you hope to gain from your membership?

A: I hope to hone my skills as a hospitalist and keep my finger on the pulse of hospital medicine. Keeping abreast of recent developments in medical knowledge and patient management is crucial to providing excellent patient care. There are also many other aspects of our day-to-day practice—for example, documentation and billing—that we weren’t taught how to manage in medical school. By joining SHM, I expect to benefit from the advice and experience of other hospitalists to improve my performance in these areas—and probably more I’ll learn about along the way.

Brett Radler is SHM’s communications coordinator.

Now with 15,000 members and growing, SHM continues to change the face of medicine—one patient at a time. We recently spoke with Dr. Glauber about her path to hospital medicine and why she believes in its continued growth and success during these times of unprecedented change.

Question: What steered you toward a career in hospital medicine?

Answer: Believe it or not, I did not enter medical school at New York Medical College with dreams of becoming a hospitalist. I first became aware of hospital medicine as a career path during my internal medicine residency at Loyola University School of Medicine in Maywood, Ill. I had some great hospitalist mentors during residency who clearly enjoyed their careers.

As I completed my training, hospital medicine was the clear choice for me. I wanted to manage patients with a variety of diagnoses and wasn’t ready to limit myself to any one subspecialty. I had always found diagnosis and management of acutely ill hospitalized patients to be the most interesting part of medicine, and I thoroughly enjoy working in the hospital environment. The field of hospital medicine was rapidly evolving, and I was curious to see where I could go with it. After four years, I can say with confidence that it has been a great experience.

Q: What do you see as the most rewarding part of your job?

A: Although my experiences practicing hospital medicine have been rewarding in a variety of ways, in the end, it’s pretty simple: I get satisfaction from helping my patients heal and helping them through the experience of hospitalization. It may take days, or it may take months to accomplish, and it is often the result of a cumulative effort of numerous hospitalists, consultants, and the entire hospital staff. But the reward for me is seeing my patient sitting in a chair, dressed in their street clothes, and waiting for their ride to come pick them up.

Q: Why do you think hospital medicine is the fastest-growing specialty in medicine? How can this momentum be sustained moving forward?

A: The growth of hospital medicine reflects the changing landscape of medicine nationwide. Hospitalist jobs are available because hospitals recognize the benefits of having us on hand to provide efficient and quality care to the patients. In terms of career choices, it is appealing to those coming straight out of residency, more experienced physicians practicing outpatient medicine, and even subspecialists who are looking for a career change. It is a satisfying and interesting job, which by nature benefits from unconventional work schedules. I think this flexibility is a big draw as well, in addition to the rewarding career.

Q: Why were you intrigued to join SHM and also attend Hospital Medicine 2016 (HM16)?

A: I think joining SHM is probably long overdue! I have been practicing for four years and feel that it’s time to take stock of my strengths and weaknesses as a hospitalist and try to improve. Through SHM, I can stay up to date on relevant medical topics, including everything from antibiotic resistance to glycemic control, as well as learn how to be a better hospitalist through the experience and research of colleagues. Attending HM16 seemed like a great way to get started, learn some new things, and network with hospitalists around the country.

Q: As a new member to SHM, what do you hope to gain from your membership?

A: I hope to hone my skills as a hospitalist and keep my finger on the pulse of hospital medicine. Keeping abreast of recent developments in medical knowledge and patient management is crucial to providing excellent patient care. There are also many other aspects of our day-to-day practice—for example, documentation and billing—that we weren’t taught how to manage in medical school. By joining SHM, I expect to benefit from the advice and experience of other hospitalists to improve my performance in these areas—and probably more I’ll learn about along the way.

Brett Radler is SHM’s communications coordinator.

Now with 15,000 members and growing, SHM continues to change the face of medicine—one patient at a time. We recently spoke with Dr. Glauber about her path to hospital medicine and why she believes in its continued growth and success during these times of unprecedented change.

Question: What steered you toward a career in hospital medicine?

Answer: Believe it or not, I did not enter medical school at New York Medical College with dreams of becoming a hospitalist. I first became aware of hospital medicine as a career path during my internal medicine residency at Loyola University School of Medicine in Maywood, Ill. I had some great hospitalist mentors during residency who clearly enjoyed their careers.

As I completed my training, hospital medicine was the clear choice for me. I wanted to manage patients with a variety of diagnoses and wasn’t ready to limit myself to any one subspecialty. I had always found diagnosis and management of acutely ill hospitalized patients to be the most interesting part of medicine, and I thoroughly enjoy working in the hospital environment. The field of hospital medicine was rapidly evolving, and I was curious to see where I could go with it. After four years, I can say with confidence that it has been a great experience.

Q: What do you see as the most rewarding part of your job?

A: Although my experiences practicing hospital medicine have been rewarding in a variety of ways, in the end, it’s pretty simple: I get satisfaction from helping my patients heal and helping them through the experience of hospitalization. It may take days, or it may take months to accomplish, and it is often the result of a cumulative effort of numerous hospitalists, consultants, and the entire hospital staff. But the reward for me is seeing my patient sitting in a chair, dressed in their street clothes, and waiting for their ride to come pick them up.

Q: Why do you think hospital medicine is the fastest-growing specialty in medicine? How can this momentum be sustained moving forward?

A: The growth of hospital medicine reflects the changing landscape of medicine nationwide. Hospitalist jobs are available because hospitals recognize the benefits of having us on hand to provide efficient and quality care to the patients. In terms of career choices, it is appealing to those coming straight out of residency, more experienced physicians practicing outpatient medicine, and even subspecialists who are looking for a career change. It is a satisfying and interesting job, which by nature benefits from unconventional work schedules. I think this flexibility is a big draw as well, in addition to the rewarding career.

Q: Why were you intrigued to join SHM and also attend Hospital Medicine 2016 (HM16)?

A: I think joining SHM is probably long overdue! I have been practicing for four years and feel that it’s time to take stock of my strengths and weaknesses as a hospitalist and try to improve. Through SHM, I can stay up to date on relevant medical topics, including everything from antibiotic resistance to glycemic control, as well as learn how to be a better hospitalist through the experience and research of colleagues. Attending HM16 seemed like a great way to get started, learn some new things, and network with hospitalists around the country.

Q: As a new member to SHM, what do you hope to gain from your membership?

A: I hope to hone my skills as a hospitalist and keep my finger on the pulse of hospital medicine. Keeping abreast of recent developments in medical knowledge and patient management is crucial to providing excellent patient care. There are also many other aspects of our day-to-day practice—for example, documentation and billing—that we weren’t taught how to manage in medical school. By joining SHM, I expect to benefit from the advice and experience of other hospitalists to improve my performance in these areas—and probably more I’ll learn about along the way.

Brett Radler is SHM’s communications coordinator.

N. Abel, MD, Alabama

A. Aboutalib, California

A. Afzal, MD, FACP, California

J. Allison, California

K. Anand, MD, California

K. Andruchow, APN, California

A. Anter, DO, California

M. Aresery, MD, California

L. Atkins, MD, California

N. Bassi, MD, PhD, California

H. Briggs, MD, PhD, California

E. Burgh, California

C. Caulfield, MD, California

P. C. Mohan, MD, California

D. Chau, MD, California

D. DeVere, MD, California

O. Dimitrijevic, MD, Colorado

P. Dodson, MD, Delaware

A. Domaoal, Florida

J. Dzundza, MD, Florida

A. Ellis, FNP, Florida

R. Erickson, Florida

A. Falescky, MD, Florida

W. Folad, MD, Georgia

K. Forb, Georgia

B. Fromkin, APN, Idaho

N. Gabriel, MD, Idaho

K. Gausewitz, Illinois

B. George, MD, Illinois

G. Goldman, MD, Kansas

A. Gonzalez, Kansas

G. Goyal, Kansas

W. Griffo, MD, Kentucky

D. Grygla, DO, MPH, FAAFP, Louisiana

B. Hammond, Louisiana

H. Haque, Louisiana

G. Harris, MD, Massachusetts

J. Harris, DO, Massachusetts

J. Hasan-Jones, FACHE, Massachusetts

L. Hsu, MD, Michigan

C. Janish, Michigan

S. Jindal, MD, Michigan

M. Johl, Minnesota

T. John, Missouri

D. Julka, MD, Missouri

O. Kamalu, MD, North Carolina

N. Kapadia, MD, New Jersey

K. Kaye, New Jersey

M. Keating, New Jersey

L. Kendall, New Jersey

M. L. Kerlin, New Jersey

T. Khan, New Jersey

A. Kim, APN, New Jersey

R. Klett, New Jersey

K. Knox, New Jersey

M. Kraynyak, MD, New Jersey

C. Larion, ACNP, New Jersey

D. Leforce, New Jersey

C. Leon, New Jersey

X. Li, MD, New Jersey

C. Maturo, DO, New Jersey

L. McGann, New York

R. Mercado Garcia, New York

J. Mikulca, PharmD, New York

M. Minock, APN, New York

Z. Moyenda, MD, MBA, New York

G. Nanna, USA, New York

I. Nasir, New York

D. Nestler, APN, New York

H. Nurse Bey, MD, New York

B. Oran, New York

N. Patel, MD, New York

V. Paulson, MD, New York

R. Porter, PA, Ohio

P. Prabhakar, Ohio

R. Quansah, MD, Ohio

F. Qureshi, MD, Ohio

M. Rahman, Ohio

R. Rajeshwar, Ohio

E. Randal, Ohio

A. Ray, Ohio

R. Regidor, Oklahoma

R. Reyes, MD, Oregon

T. Richardson, NP, Oregon

L. Rivera-Crespo, Oregon

T. Rothwell, PA, Oregon

E. Sacolick, MD, Pennsylvania

D. Sakai, Pennsylvania

M. Sapon-Amoah, FNP, Pennsylvania

M. M. Scoulos-Hanson, Pennsylvania

K. Seger, Pennsylvania

K. Shah, MD, Pennsylvania

S. Shah, MD, Pennsylvania

K. Shaukat, MD, Pennsylvania

J. Shipe-Spotloe, MS, PA-C, Pennsylvania

S. Sim, South Carolina

M. N. Simon, MD, MMM, CPE, South Carolina

A. Singh, South Carolina

S. Singh-Patel, DO, South Carolina

A. Srikanth, MBBS, South Carolina

R. Stanhiser, MD, Tennessee

J. Steinberg, MD, PhD, ACLS, Texas

L. Taylor, PA-C, Texas

E. Taylor, MD, Texas

L. Theaker, Texas

M. Thieman, Texas

J. Tong, Texas

L. Tuazon, MD, FACP, Texas

S. Tummalapalli, Utah

A. Ufferman, MD, Washington

N. Van Groningen, Washington

D. Vaughn, MD, Washington

K. Vo, Washington

T. Washko, MD, Wisconson

T. Waters, DO, West Virginia

L. Weisberger, USA, West Virginia

K. Welch, West Virginia

A. Whitehead, West Virginia

A. Yoon, MD, West Virginia

M. A. Yu, West Virginia

A. Yuen, DO, West Virginia

N. Abel, MD, Alabama

A. Aboutalib, California

A. Afzal, MD, FACP, California

J. Allison, California

K. Anand, MD, California

K. Andruchow, APN, California

A. Anter, DO, California

M. Aresery, MD, California

L. Atkins, MD, California

N. Bassi, MD, PhD, California

H. Briggs, MD, PhD, California

E. Burgh, California

C. Caulfield, MD, California

P. C. Mohan, MD, California

D. Chau, MD, California

D. DeVere, MD, California

O. Dimitrijevic, MD, Colorado

P. Dodson, MD, Delaware

A. Domaoal, Florida

J. Dzundza, MD, Florida

A. Ellis, FNP, Florida

R. Erickson, Florida

A. Falescky, MD, Florida

W. Folad, MD, Georgia

K. Forb, Georgia

B. Fromkin, APN, Idaho

N. Gabriel, MD, Idaho

K. Gausewitz, Illinois

B. George, MD, Illinois

G. Goldman, MD, Kansas

A. Gonzalez, Kansas

G. Goyal, Kansas

W. Griffo, MD, Kentucky

D. Grygla, DO, MPH, FAAFP, Louisiana

B. Hammond, Louisiana

H. Haque, Louisiana

G. Harris, MD, Massachusetts

J. Harris, DO, Massachusetts

J. Hasan-Jones, FACHE, Massachusetts

L. Hsu, MD, Michigan

C. Janish, Michigan

S. Jindal, MD, Michigan

M. Johl, Minnesota

T. John, Missouri

D. Julka, MD, Missouri

O. Kamalu, MD, North Carolina

N. Kapadia, MD, New Jersey

K. Kaye, New Jersey

M. Keating, New Jersey

L. Kendall, New Jersey

M. L. Kerlin, New Jersey

T. Khan, New Jersey

A. Kim, APN, New Jersey

R. Klett, New Jersey

K. Knox, New Jersey

M. Kraynyak, MD, New Jersey

C. Larion, ACNP, New Jersey

D. Leforce, New Jersey

C. Leon, New Jersey

X. Li, MD, New Jersey

C. Maturo, DO, New Jersey

L. McGann, New York

R. Mercado Garcia, New York

J. Mikulca, PharmD, New York

M. Minock, APN, New York

Z. Moyenda, MD, MBA, New York

G. Nanna, USA, New York

I. Nasir, New York

D. Nestler, APN, New York

H. Nurse Bey, MD, New York

B. Oran, New York

N. Patel, MD, New York

V. Paulson, MD, New York

R. Porter, PA, Ohio

P. Prabhakar, Ohio

R. Quansah, MD, Ohio

F. Qureshi, MD, Ohio

M. Rahman, Ohio

R. Rajeshwar, Ohio

E. Randal, Ohio

A. Ray, Ohio

R. Regidor, Oklahoma

R. Reyes, MD, Oregon

T. Richardson, NP, Oregon

L. Rivera-Crespo, Oregon

T. Rothwell, PA, Oregon

E. Sacolick, MD, Pennsylvania

D. Sakai, Pennsylvania

M. Sapon-Amoah, FNP, Pennsylvania

M. M. Scoulos-Hanson, Pennsylvania

K. Seger, Pennsylvania

K. Shah, MD, Pennsylvania

S. Shah, MD, Pennsylvania

K. Shaukat, MD, Pennsylvania

J. Shipe-Spotloe, MS, PA-C, Pennsylvania

S. Sim, South Carolina

M. N. Simon, MD, MMM, CPE, South Carolina

A. Singh, South Carolina

S. Singh-Patel, DO, South Carolina

A. Srikanth, MBBS, South Carolina

R. Stanhiser, MD, Tennessee

J. Steinberg, MD, PhD, ACLS, Texas

L. Taylor, PA-C, Texas

E. Taylor, MD, Texas

L. Theaker, Texas

M. Thieman, Texas

J. Tong, Texas

L. Tuazon, MD, FACP, Texas

S. Tummalapalli, Utah

A. Ufferman, MD, Washington

N. Van Groningen, Washington

D. Vaughn, MD, Washington

K. Vo, Washington

T. Washko, MD, Wisconson

T. Waters, DO, West Virginia

L. Weisberger, USA, West Virginia

K. Welch, West Virginia

A. Whitehead, West Virginia

A. Yoon, MD, West Virginia

M. A. Yu, West Virginia

A. Yuen, DO, West Virginia

N. Abel, MD, Alabama

A. Aboutalib, California

A. Afzal, MD, FACP, California

J. Allison, California

K. Anand, MD, California

K. Andruchow, APN, California

A. Anter, DO, California

M. Aresery, MD, California

L. Atkins, MD, California

N. Bassi, MD, PhD, California

H. Briggs, MD, PhD, California

E. Burgh, California

C. Caulfield, MD, California

P. C. Mohan, MD, California

D. Chau, MD, California

D. DeVere, MD, California

O. Dimitrijevic, MD, Colorado

P. Dodson, MD, Delaware

A. Domaoal, Florida

J. Dzundza, MD, Florida

A. Ellis, FNP, Florida

R. Erickson, Florida

A. Falescky, MD, Florida

W. Folad, MD, Georgia

K. Forb, Georgia

B. Fromkin, APN, Idaho

N. Gabriel, MD, Idaho

K. Gausewitz, Illinois

B. George, MD, Illinois

G. Goldman, MD, Kansas

A. Gonzalez, Kansas

G. Goyal, Kansas

W. Griffo, MD, Kentucky

D. Grygla, DO, MPH, FAAFP, Louisiana

B. Hammond, Louisiana

H. Haque, Louisiana

G. Harris, MD, Massachusetts

J. Harris, DO, Massachusetts

J. Hasan-Jones, FACHE, Massachusetts

L. Hsu, MD, Michigan

C. Janish, Michigan

S. Jindal, MD, Michigan

M. Johl, Minnesota

T. John, Missouri

D. Julka, MD, Missouri

O. Kamalu, MD, North Carolina

N. Kapadia, MD, New Jersey

K. Kaye, New Jersey

M. Keating, New Jersey

L. Kendall, New Jersey

M. L. Kerlin, New Jersey

T. Khan, New Jersey

A. Kim, APN, New Jersey

R. Klett, New Jersey

K. Knox, New Jersey

M. Kraynyak, MD, New Jersey

C. Larion, ACNP, New Jersey

D. Leforce, New Jersey

C. Leon, New Jersey

X. Li, MD, New Jersey

C. Maturo, DO, New Jersey

L. McGann, New York

R. Mercado Garcia, New York

J. Mikulca, PharmD, New York

M. Minock, APN, New York

Z. Moyenda, MD, MBA, New York

G. Nanna, USA, New York

I. Nasir, New York

D. Nestler, APN, New York

H. Nurse Bey, MD, New York

B. Oran, New York

N. Patel, MD, New York

V. Paulson, MD, New York

R. Porter, PA, Ohio

P. Prabhakar, Ohio

R. Quansah, MD, Ohio

F. Qureshi, MD, Ohio

M. Rahman, Ohio

R. Rajeshwar, Ohio

E. Randal, Ohio

A. Ray, Ohio

R. Regidor, Oklahoma

R. Reyes, MD, Oregon

T. Richardson, NP, Oregon

L. Rivera-Crespo, Oregon

T. Rothwell, PA, Oregon

E. Sacolick, MD, Pennsylvania

D. Sakai, Pennsylvania

M. Sapon-Amoah, FNP, Pennsylvania

M. M. Scoulos-Hanson, Pennsylvania

K. Seger, Pennsylvania

K. Shah, MD, Pennsylvania

S. Shah, MD, Pennsylvania

K. Shaukat, MD, Pennsylvania

J. Shipe-Spotloe, MS, PA-C, Pennsylvania

S. Sim, South Carolina

M. N. Simon, MD, MMM, CPE, South Carolina

A. Singh, South Carolina

S. Singh-Patel, DO, South Carolina

A. Srikanth, MBBS, South Carolina

R. Stanhiser, MD, Tennessee

J. Steinberg, MD, PhD, ACLS, Texas

L. Taylor, PA-C, Texas

E. Taylor, MD, Texas

L. Theaker, Texas

M. Thieman, Texas

J. Tong, Texas

L. Tuazon, MD, FACP, Texas

S. Tummalapalli, Utah

A. Ufferman, MD, Washington

N. Van Groningen, Washington

D. Vaughn, MD, Washington

K. Vo, Washington

T. Washko, MD, Wisconson

T. Waters, DO, West Virginia

L. Weisberger, USA, West Virginia

K. Welch, West Virginia

A. Whitehead, West Virginia

A. Yoon, MD, West Virginia

M. A. Yu, West Virginia

A. Yuen, DO, West Virginia

(Reuters Health) - When it comes to urgent medical problems like ankle injuries or suspected strep, virtual MDs may be no match for the real thing, a new U.S. study suggests.

Researchers enlisted 67 volunteers to test out how well eight popular virtual visit companies diagnosed these problems and four other common medical issues - sore throat, sinus infection, low back pain, and urinary tract infection.

About one in four patients got the wrong diagnosis or none at all from the virtual visits, the study found. What's more, virtual doctors followed standard protocols for diagnosing and treating these problems only 54% of the time.

"One of the more surprising findings of the study was the universally low rate of testing when it was needed," said lead researcher Dr. Adam Schoenfeld, of the University of California, San Francisco.

"We don't know why, but it may reflect the challenges of ordering or following up on tests performed near where the patient lives but far from where the doctor is, or concern about the costs to the patient of additional testing," Schoenfeld added by email.

Virtual visits using videoconferences, phone calls and web chats are becoming a more common way for patients to seek urgent care because it can save the inconvenience of a clinic visit or provide access to care when people can't get an appointment with their regular doctor.

Some insurers are starting to pay for virtual visits in certain situations, making this option more viable for patients who worry about costs.

For the current study, Schoenfeld and colleagues trained volunteers to act as if they had common acute medical problems and then sent them to virtual doctors provided by companies including Ameridoc, Amwell, Consult a Doctor, Doctor on Demand, MDAligne, MDLIVE, MeMD and NowClinic.

Altogether, the volunteers completed 599 virtual visits in 2013 and 2014.

The companies varied in how well they followed treatment guidelines, with standard care given anywhere from 34 to 66% of the time across the eight websites, the researchers report in JAMA Internal Medicine April 4.

Mode of communication - such as web chat or videoconference - didn't appear to influence how often treatment guidelines were

followed.

Virtual doctors got complete histories and did thorough exams anywhere from 52% to 82% of the time.   Virtual visits resulted in correct diagnoses anywhere from 65% to 94% of the time.

Often, virtual doctors failed to order urine tests needed to assess urinary tract infections, or to request images needed to diagnoses ankle pain, for example, and antibiotics were often prescribed inappropriately.

One limitation of the study is that the researchers only looked at virtual visits, so they couldn't compare these online doctors' visits to what might have happened with in-person clinical exams.

Still, it's possible that at least some of the variation in quality of care was the result of the remote visits, said Dr. Jeffrey Linder, a researcher at Brigham and Women's Hospital and Harvard Medical School who co-authored an editorial accompanying the study.

"There is a built-in barrier to getting testing, which led to worse care for ankle pain and recurrent urinary tract infections - for which the doctors should have ordered a test - and better care for low back pain - for which doctors should not have ordered a test," Linder said by email.

In an ideal world, patients would be able to have occasional virtual visits with their primary care providers, who know their medical histories, said Dr. David Levine, co-author of the editorial and also a researcher at Brigham and Women's and Harvard.

Although virtual urgent care and in-person urgent care have not been compared head-to-head, virtual urgent care has its downsides - indirect physical exam, difficult access to testing, and unclear follow-up," Levine said by email. "While the quality of care is not perfect anywhere, a patient's primary care doctor should be a person's first point of contact."

(Reuters Health) - When it comes to urgent medical problems like ankle injuries or suspected strep, virtual MDs may be no match for the real thing, a new U.S. study suggests.

Researchers enlisted 67 volunteers to test out how well eight popular virtual visit companies diagnosed these problems and four other common medical issues - sore throat, sinus infection, low back pain, and urinary tract infection.

About one in four patients got the wrong diagnosis or none at all from the virtual visits, the study found. What's more, virtual doctors followed standard protocols for diagnosing and treating these problems only 54% of the time.

"One of the more surprising findings of the study was the universally low rate of testing when it was needed," said lead researcher Dr. Adam Schoenfeld, of the University of California, San Francisco.

"We don't know why, but it may reflect the challenges of ordering or following up on tests performed near where the patient lives but far from where the doctor is, or concern about the costs to the patient of additional testing," Schoenfeld added by email.

Virtual visits using videoconferences, phone calls and web chats are becoming a more common way for patients to seek urgent care because it can save the inconvenience of a clinic visit or provide access to care when people can't get an appointment with their regular doctor.

Some insurers are starting to pay for virtual visits in certain situations, making this option more viable for patients who worry about costs.

For the current study, Schoenfeld and colleagues trained volunteers to act as if they had common acute medical problems and then sent them to virtual doctors provided by companies including Ameridoc, Amwell, Consult a Doctor, Doctor on Demand, MDAligne, MDLIVE, MeMD and NowClinic.

Altogether, the volunteers completed 599 virtual visits in 2013 and 2014.

The companies varied in how well they followed treatment guidelines, with standard care given anywhere from 34 to 66% of the time across the eight websites, the researchers report in JAMA Internal Medicine April 4.

Mode of communication - such as web chat or videoconference - didn't appear to influence how often treatment guidelines were

followed.

Virtual doctors got complete histories and did thorough exams anywhere from 52% to 82% of the time.   Virtual visits resulted in correct diagnoses anywhere from 65% to 94% of the time.

Often, virtual doctors failed to order urine tests needed to assess urinary tract infections, or to request images needed to diagnoses ankle pain, for example, and antibiotics were often prescribed inappropriately.

One limitation of the study is that the researchers only looked at virtual visits, so they couldn't compare these online doctors' visits to what might have happened with in-person clinical exams.

Still, it's possible that at least some of the variation in quality of care was the result of the remote visits, said Dr. Jeffrey Linder, a researcher at Brigham and Women's Hospital and Harvard Medical School who co-authored an editorial accompanying the study.

"There is a built-in barrier to getting testing, which led to worse care for ankle pain and recurrent urinary tract infections - for which the doctors should have ordered a test - and better care for low back pain - for which doctors should not have ordered a test," Linder said by email.

In an ideal world, patients would be able to have occasional virtual visits with their primary care providers, who know their medical histories, said Dr. David Levine, co-author of the editorial and also a researcher at Brigham and Women's and Harvard.

Although virtual urgent care and in-person urgent care have not been compared head-to-head, virtual urgent care has its downsides - indirect physical exam, difficult access to testing, and unclear follow-up," Levine said by email. "While the quality of care is not perfect anywhere, a patient's primary care doctor should be a person's first point of contact."

(Reuters Health) - When it comes to urgent medical problems like ankle injuries or suspected strep, virtual MDs may be no match for the real thing, a new U.S. study suggests.

Researchers enlisted 67 volunteers to test out how well eight popular virtual visit companies diagnosed these problems and four other common medical issues - sore throat, sinus infection, low back pain, and urinary tract infection.

About one in four patients got the wrong diagnosis or none at all from the virtual visits, the study found. What's more, virtual doctors followed standard protocols for diagnosing and treating these problems only 54% of the time.

"One of the more surprising findings of the study was the universally low rate of testing when it was needed," said lead researcher Dr. Adam Schoenfeld, of the University of California, San Francisco.

"We don't know why, but it may reflect the challenges of ordering or following up on tests performed near where the patient lives but far from where the doctor is, or concern about the costs to the patient of additional testing," Schoenfeld added by email.

Virtual visits using videoconferences, phone calls and web chats are becoming a more common way for patients to seek urgent care because it can save the inconvenience of a clinic visit or provide access to care when people can't get an appointment with their regular doctor.

Some insurers are starting to pay for virtual visits in certain situations, making this option more viable for patients who worry about costs.

For the current study, Schoenfeld and colleagues trained volunteers to act as if they had common acute medical problems and then sent them to virtual doctors provided by companies including Ameridoc, Amwell, Consult a Doctor, Doctor on Demand, MDAligne, MDLIVE, MeMD and NowClinic.

Altogether, the volunteers completed 599 virtual visits in 2013 and 2014.

The companies varied in how well they followed treatment guidelines, with standard care given anywhere from 34 to 66% of the time across the eight websites, the researchers report in JAMA Internal Medicine April 4.

Mode of communication - such as web chat or videoconference - didn't appear to influence how often treatment guidelines were

followed.

Virtual doctors got complete histories and did thorough exams anywhere from 52% to 82% of the time.   Virtual visits resulted in correct diagnoses anywhere from 65% to 94% of the time.

Often, virtual doctors failed to order urine tests needed to assess urinary tract infections, or to request images needed to diagnoses ankle pain, for example, and antibiotics were often prescribed inappropriately.

One limitation of the study is that the researchers only looked at virtual visits, so they couldn't compare these online doctors' visits to what might have happened with in-person clinical exams.

Still, it's possible that at least some of the variation in quality of care was the result of the remote visits, said Dr. Jeffrey Linder, a researcher at Brigham and Women's Hospital and Harvard Medical School who co-authored an editorial accompanying the study.

"There is a built-in barrier to getting testing, which led to worse care for ankle pain and recurrent urinary tract infections - for which the doctors should have ordered a test - and better care for low back pain - for which doctors should not have ordered a test," Linder said by email.

In an ideal world, patients would be able to have occasional virtual visits with their primary care providers, who know their medical histories, said Dr. David Levine, co-author of the editorial and also a researcher at Brigham and Women's and Harvard.

Although virtual urgent care and in-person urgent care have not been compared head-to-head, virtual urgent care has its downsides - indirect physical exam, difficult access to testing, and unclear follow-up," Levine said by email. "While the quality of care is not perfect anywhere, a patient's primary care doctor should be a person's first point of contact."