Robert Wood Johnson Foundation Clinical Research Articles

Health Care Equity and Justice Scorecard To Increase Diversity in Clinical Trial Recruitment and Retention.

Health Care Equity and Justice Scorecard To Increase Diversity in Clinical Trial Recruitment and Retention.

The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.

Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs. To examine the clinical evidence for approval and association with prices and shortages of previously unapproved prescription drugs after being addressed by the UDI. Previously unapproved prescription drugs that faced UDI regulatory action or with at least 1 product that received FDA approval through manufacturers' voluntary compliance with the UDI between 2006 and 2015 were identified. The clinical evidence was categorized as either newly conducted clinical trials or use of previously published literature and/or bioequivalence studies to demonstrate safety and efficacy. We determined the change in average wholesale price, presence of shortage, and duration of shortage for each drug during the 2 years before and after UDI regulatory action or approval through voluntary compliance. Between 2006 and 2015, 34 previously unapproved prescription drugs were addressed by the UDI. Nearly 90% of those with a drug product that received FDA approval were supported by literature reviews or bioequivalence studies, not new clinical trial evidence. Among the 26 drugs with available pricing data, average wholesale price during the 2 years before and after voluntary approval or UDI action increased by a median of 37% (interquartile range [IQR] = 23%-204%; P < 0.001). The number of drugs in shortage increased from 17 (50.0%) to 25 (73.5%) during the 2 years before and after, respectively (P = 0.046). The median shortage duration in the 2 years before and after voluntary approval or UDI action increased from 31 days (IQR = 0-339) to 217 days (IQR = 0-406; P = 0.053). The UDI was associated with higher drug prices and more frequent drug shortages when compared with the period before UDI action, while the approval process for these drugs did not necessarily require new clinical evidence to establish safety or efficacy. This project was not supported by any external grants or funds. Gupta was supported by the Yale University School of Medicine Office of Student Research at the time of this study. Dhruva is supported by the Department of Veterans Affairs as part of the Robert Wood Johnson Foundation Clinical Scholars program. Ross reports receiving research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing; from Medtronic and the FDA to develop methods for postmarket surveillance of medical devices; from the FDA to establish the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation; from the Blue Cross Blue Shield Association to better understand medical technology evidence generation; from the Centers for Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting; and from the Laura and John Arnold Foundation to support the Collaboration on Research Integrity and Transparency at Yale. Fox reports travel support from Oklahoma Society of Health System Pharmacists, Premier Oncology Hematology Management Society, and SEHA-United Arab Emirates. Vizient provides some financial support to the University of Utah Drug Information Service to provide summaries of drug shortage information. Gupta and Ross were responsible for the conception and design of this work, drafted the manuscript, and conducted the statistical analysis. Gupta and Fox were responsible for acquisition of data. Ross provided supervision. All authors participated in the analysis and interpretation of the data and critically revised the manuscript for important intellectual content.

The Relationship of Obesity to Hospice Use and Expenditures: A Cohort Study.

Obesity complicates medical, nursing, and informal care in severe illness, but its effect on hospice use and Medicare expenditures is unknown. To describe the associations between body mass index (BMI) and hospice use and Medicare expenditures in the last 6 months of life. Retrospective cohort. The HRS (Health and Retirement Study). 5677 community-dwelling Medicare fee-for-service beneficiaries who died between 1998 and 2012. Hospice enrollment, days enrolled in hospice, in-home death, and total Medicare expenditures in the 6 months before death. Body mass index was modeled as a continuous variable with a quadratic functional form. For decedents with BMI of 20 kg/m2, the predicted probability of hospice enrollment was 38.3% (95% CI, 36.5% to 40.2%), hospice duration was 42.8 days (CI, 42.3 to 43.2 days), probability of in-home death was 61.3% (CI, 59.4% to 63.2%), and total Medicare expenditures were $42803 (CI, $41085 to $44521). When BMI increased to 30 kg/m2, the predicted probability of hospice enrollment decreased by 6.7 percentage points (CI, -9.3 to -4.0 percentage points), hospice duration decreased by 3.8 days (CI, -4.4 to -3.1 days), probability of in-home death decreased by 3.2 percentage points (CI, -6.0 to -0.4 percentage points), and total Medicare expenditures increased by $3471 (CI, $955 to $5988). For morbidly obese decedents (BMI ≥40 kg/m2), the predicted probability of hospice enrollment decreased by 15.2 percentage points (CI, -19.6 to -10.9 percentage points), hospice duration decreased by 4.3 days (CI, -5.7 to -2.9 days), and in-home death decreased by 6.3 percentage points (CI, -11.2 to -1.5 percentage points) versus decedents with BMI of 20 kg/m2. Baseline data were self-reported, and the interval between reported BMI and time of death varied. Among community-dwelling decedents in the HRS, increasing obesity was associated with reduced hospice use and in-home death and higher Medicare expenditures in the last 6 months of life. Robert Wood Johnson Foundation Clinical Scholars Program.

Effectiveness of a smartphone application for weight loss compared with usual care in overweight primary care patients: a randomized, controlled trial.

Many smartphone applications (apps) for weight loss are available, but little is known about their effectiveness. To evaluate the effect of introducing primary care patients to a free smartphone app for weight loss. Randomized, controlled trial. (ClinicalTrials.gov: NCT01650337). 2 academic primary care clinics. 212 primary care patients with body mass index of 25 kg/m2 or greater. 6 months of usual care without (n= 107) or with (n= 105) assistance in downloading the MyFitnessPal app (MyFitnessPal). Weight loss at 6 months (primary outcome) and changes in systolic blood pressure and behaviors, frequency of app use, and satisfaction (secondary outcomes). After 6 months, weight change was minimal, with no difference between groups (mean between-group difference, -0.30 kg [95% CI, -1.50 to 0.95 kg]; P= 0.63). Change in systolic blood pressure also did not differ between groups (mean between-group difference, -1.7 mm Hg [CI, -7.1 to 3.8 mm Hg]; P= 0.55). Compared with patients in the control group, those in the intervention group increased use of a personal calorie goal (mean between-group difference, 2.0 d/wk [CI, 1.1 to 2.9 d/wk]; P< 0.001), although other self-reported behaviors did not differ between groups. Most users reported high satisfaction with MyFitnessPal, but logins decreased sharply after the first month. Despite being blinded to the name of the app, 14 control group participants (13%) used MyFitnessPal. In addition, 32% of intervention group participants and 19% of control group participants were lost to follow-up at 6 months. The app was given to patients by research assistants, not by physicians. Smartphone apps for weight loss may be useful for persons who are ready to self-monitor calories, but introducing a smartphone app is unlikely to produce substantial weight change for most patients. Robert Wood Johnson Foundation Clinical Scholars Program, National Institutes of Health/National Center for Advancing Translational Sciences for the UCLA Clinical and Translational Science Institute, and the Resource Centers for Minority Aging Research Center for Health Improvement of Minority Elderly under the National Institutes of Health/National Institute on Aging.

Moving the Discourse on Quality in Pediatrics: Recent Contributions of Robert Wood Johnson Foundation Clinical Scholars

* Abbreviations: RWJF — : Robert Wood Johnson Foundation UCLA — : University of California, Los Angeles This issue links together a broad construct (quality) in a defined population (children) with alumni from a specific training program. In so doing, it is both a celebration and a challenge. The supplement celebrates the contributions of Robert Wood Johnson Foundation (RWJF) Clinical Scholars to the national discourse regarding the measurement and improvement of quality; it acknowledges the increasing prominence of child health work as part of the national quality agenda and the hope for filling the many gaps regarding our understanding of how to measure and improve children’s health care. Children’s health care quality has become a major part on the research agenda of pediatric participants in the RWJF Clinical Scholars Program. Alumni of this program have in turn nurtured additional health services research and quality fellowships at other institutions and have helped build this area of inquiry in pediatrics. The Clinical Scholars Program marks its 40th anniversary this year. This is a remarkable milestone of sustained support for any US philanthropy but even more so when the outlines of the history of the RWJF are filled in. As the story goes, in the late 1960s, physicians from a handful of prominent institutions were gathered (whether it was in a bar was not recorded) after a national meeting and chatting with leaders of The Commonwealth Fund and the Carnegie Corporation about the need for advanced training in the nonbiological sciences to create a career development path for clinicians who were intellectually inclined and humanistic but not inclined to laboratory training. Out of this conversation came an invitation to submit a proposal; that proposal evolved into a postresidency academic fellowship in the nonbiological sciences that would be national in scope and local in character. It was first funded in 1969 and built on institutional strengths (at Johns Hopkins University, University … Address correspondence to Lawrence C. Kleinman, MD, MPH, Department of Health Evidence and Policy, Mount Sinai School of Medicine, One Gustave Levy Place, Box 1077, New York, NY 10029. E-mail: lawrence.kleinman{at}mountsinai.org

A Measure of Care Coordination?

The Dartmouth Institute for Health Policy and Clinical Practice and Department of Medicine, Geisel School of Medicine at Dartmouth, Lebanon, NH, USA; Section of General Internal Medicine and Robert Wood Johnson Foundation Clinical Scholars Program, Department of Medicine, Yale University School of Medicine and Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.

Duration of resuscitation efforts and survival after in-hospital cardiac arrest: an observational study

During in-hospital cardiac arrests, how long resuscitation attempts should be continued before termination of efforts is unknown. We investigated whether duration of resuscitation attempts varies between hospitals and whether patients at hospitals that attempt resuscitation for longer have higher survival rates than do those at hospitals with shorter durations of resuscitation efforts. Between 2000 and 2008, we identified 64,339 patients with cardiac arrests at 435 US hospitals within the Get With The Guidelines—Resuscitation registry. For each hospital, we calculated the median duration of resuscitation before termination of efforts in non-survivors as a measure of the hospital's overall tendency for longer attempts. We used multilevel regression models to assess the association between the length of resuscitation attempts and risk-adjusted survival. Our primary endpoints were immediate survival with return of spontaneous circulation during cardiac arrest and survival to hospital discharge. 31,198 of 64,339 (48·5%) patients achieved return of spontaneous circulation and 9912 (15·4%) survived to discharge. For patients achieving return of spontaneous circulation, the median duration of resuscitation was 12 min (IQR 6-21) compared with 20 min (14-30) for non-survivors. Compared with patients at hospitals in the quartile with the shortest median resuscitation attempts in non-survivors (16 min [IQR 15-17]), those at hospitals in the quartile with the longest attempts (25 min [25-28]) had a higher likelihood of return of spontaneous circulation (adjusted risk ratio 1·12, 95% CI 1·06-1·18; p<0·0001) and survival to discharge (1·12, 1·02-1·23; 0·021). Duration of resuscitation attempts varies between hospitals. Although we cannot define an optimum duration for resuscitation attempts on the basis of these observational data, our findings suggest that efforts to systematically increase the duration of resuscitation could improve survival in this high-risk population. American Heart Association, Robert Wood Johnson Foundation Clinical Scholars Program, and the National Institutes of Health.

Building an Accountable Care Organization for All the Wrong Reasons

Building an Accountable Care Organization for All the Wrong Reasons

Patient Interest in Sharing Personal Health Record Information

Electronic personal health record (PHR) systems are proliferating but largely have not realized their potential for enhancing communication among patients and their network of care providers. To explore preferences about sharing electronic health information among users of the U.S. Department of Veterans Affairs (VA) PHR system, My HealtheVet. Web-based survey of a convenience sample. My HealtheVet Web site from 7 July through 4 October 2010. 18 471 users of My HealtheVet. Interest in shared PHR access and preferences about who would receive access, the information that would be shared, and the activities that users would delegate. Survey respondents were predominantly men (92%) and aged 50 to 64 years (51%) or 65 years or older (39%); approximately 39% reported poor or fair health status. Almost 4 of 5 respondents (79%) were interested in sharing access to their PHR with someone outside of their health system (62% with a spouse or partner, 23% with a child, 15% with another family member, and 25% with a non-VA health care provider). Among those who selected a family member other than a spouse or partner, 47% lived apart from the specified person. Preferences about degree of access varied on the basis of the type of information being shared, the type of activity being performed, and the respondent's relationship with the selected person. The survey completion rate was 40.8%. Results might not be generalizable to all My HealtheVet users. In a large survey of PHR users in the VA system, most respondents were interested in sharing access to their electronic health information with caregivers and non-VA providers. Existing and evolving PHR systems should explore secure mechanisms for shared PHR access to improve information exchange among patients and the multiple persons involved in their health care. Veterans Health Administration and The Robert Wood Johnson Foundation Clinical Scholars Program.

A Physician on Capitol Hill: An Outsider on the Inside

From the Robert Wood Johnson Foundation Clinical Scholars Program and the Leonard Davis Institute of Health Economics at the University of Pennsylvania and the Division of Child Development, Rehabilitation, andMetabolic Disease in the Department of Pediatrics, The Children’s Hospital of Philadelphia Address correspondence to Manuel E. Jimenez, MD, 423 Guardian Dr, 13th Fl Blockley Hall, Philadelphia, Pennsylvania 19104 (e-mail: mjimenez@upenn.edu).

Marcella Nunez Smith, MD, MHS

Marcella Nunez Smith, MD, MHS, is assistant director of the Robert Wood Johnson Foundation Clinical Scholars Program and assistant professor of the Section of General Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.

Understanding the Barriers to the Dissemination of Medical Expulsive Therapy

Increasing trial evidence suggests that a course of medical expulsive therapy is warranted for patients with ureteral stones who are amenable to conservative treatment, and that this efficacious process of care is underused. To better understand the barriers to the dissemination of medical expulsive therapy we analyzed health care claims of working age adults with urinary stone disease. Using MarketScan® data (2002 to 2006) we identified patients with urinary stone disease who were treated in the emergency department. We characterized differences between patients who were prescribed medical expulsive therapy and those who were not. After assigning patients to their principal providers we determined how much of the variation in medical expulsive therapy prescribing rates was attributable to patient vs provider level factors. A total of 79,688 patients were seen for an acute stone episode. They received care from 12,328 providers. In general those patients prescribed medical expulsive therapy tended to be older (p<0.001) and were more likely male (p<0.001). A higher percentage of medical expulsive therapy recipients were salaried (p=0.003) and had full-time employment (p<0.001). Of the unexplained variation in medical expulsive therapy prescription 21% was accounted for by unmeasured provider factors and patient odds of receiving medical expulsive therapy were 5-fold higher if seen by a urologist (OR 4.94, 95% CI 2.96-8.28, p<0.001). These data reveal that the provider seen for an episode of renal colic substantially determines whether the patient will receive medical expulsive therapy. As such, an educational intervention directed toward emergency department physicians might hasten the uptake of medical expulsive therapy within the broader medical community.

The Robert Wood Johnson Foundation Clinical Scholars Program and Emergency Medicine

Specialized research training for emergency physicians (EPs) may strengthen overall patient care through the development and improvement of clinical evidence in emergency care. One way an increasing number of emergency physicians have acquired these skills is through the Robert Wood Johnson Foundation Clinical Scholars Program (CSP), a 2-year fellowship that trains physicians to be leaders in improving health care. In addition to providing training in health policy and health services research, the CSP emphasizes the translation of research into action through leadership training, program development, and community-based participatory research. This article provides an in-depth look at the CSP and its impact on emergency medicine (EM). To date, 41 EPs have trained through the program, with increasing numbers in recent years. Graduates have gone on to become leaders in academia, public health, private industry, and foundations. Past and present EM-trained Clinical Scholars are working to find creative solutions for the challenges posed by the U.S. health care system and improve the delivery of emergency care. Emergency physicians who wish to conduct research or work with communities, organizations, practitioners, and policy-makers to address issues essential to the health and well-being of all Americans should consider the Robert Wood Johnson Foundation CSP.

Maternal affective or substance disorders are risk factors for subsequent pregnancy loss

ED FROM Gold KJ, Dalton VK, Schwenk TL, et al. What causes pregnancy loss? Preexisting mental illness as an independent risk factor. Gen Hosp Psychiatry 2007;29:207–13. Notes: This study relies...

Tribute to John M. Eisenberg

This issue is dedicated as a tribute to John M. Eisenberg, M.D., M.B.A., in recognition of his lifelong achievements in health services research. We have selected six articles, described below, which represent areas where John made significant contributions, either as a researcher and administrator or as a champion and mentor. In addition, on behalf of the entire Editorial Board of HSR, our publisher, and the leadership at AcademyHealth, we would like to announce the establishment of an award for excellence in health services research, designed to recognize exceptional articles from HSR which advance our understanding in an area championed by John. Selection of these awards will be announced periodically in HSR, beginning in 2004. We also gratefully acknowledge support for the publication of this tribute provided by a grant from The Robert Wood Johnson Foundation in Princeton, NJ, and funding by W.K. Kellogg Foundation in Battle Creek, MI. John Meyer Eisenberg was born in Atlanta, Georgia, in 1946 and died from a brain tumor on March 10, 2002. From 1997 until shortly before his death, John served as Director for the Agency for Healthcare Research and Quality (AHRQ; formerly called the Agency for Health Care Policy and Research) of the U.S. Department of Health and Human Services (HHS). He also served as the Senior Advisor to the Secretary of HHS on Quality; cochaired the Department's Data Council; chaired the Federal Quality Interagency Coordination Task Force; and served as Principal Deputy Assistant Secretary for Health and as Acting Assistant Secretary for Health. Although this partial list of his titles illustrate the breadth and importance of his many contributions to the nation's health care system, it fails to capture the charisma, enthusiasm, and strengths with which he tackled these roles and policy areas. He was a champion of policy-relevant research in order to increase the “value” of health care services by improving its appropriateness, safety, and effectiveness while also monitoring and improving its accessibility to all. In taking on these challenges, he managed to engage researchers, clinicians, and policymakers alike in his vision for excellence in research to improve the nation's health care. He recognized that such efforts required continuous encouragement and mentoring of those who would undertake them. He was a magna cum laude graduate of Princeton University (1968) and the Washington University School of Medicine in St. Louis (1972). He was also a Robert Wood Johnson Foundation Clinical Scholar, earning a Master of Business Administration degree with distinction at the Wharton School. A clinician and researcher from the beginning of his career, John held many key positions in academic and clinical medicine and was widely recognized as a leader in both medicine and health services research. His positions included Chair, Physician Payment Review Commission; President, Association for Health Services Research (now AcademyHealth); President, Society for General Internal Medicine; and Vice President, Society for Medical Decision Making. He was also a member of the Institute of Medicine of the National Academy of Sciences and published over 250 articles and book chapters on topics such as physicians' practices, test use and efficacy, medical education, and clinical economics, as well as writing a seminal book that influenced how many of us view medical decision making: Doctors' Decisions and the Cost of Medical Care (Eisenberg 1986). John dedicated his career to ensuring that health care is based on a strong foundation of research. He challenged the field to address topics important to policymakers—both inside the clinic and inside the “Beltway”—with research that was methodologically sound, grounded in the “real world” and accessible to a broad audience. The first six articles in this issue were selected as a tribute to his contributions in these arenas:

Prescription Drugs, Practicing Physicians, and the Elderly

Prologue: A key element of the success of any medical regimen is the physician/patient relationship. Because of its potential impact on quality of care, policymakers retain a lively interest in this interaction. In this article, Risa Lavizzo-Mourey and John Eisenberg examine the impact of prescription drug policies on the physician/patient relationship, focusing on the elderly. “As clinicians and health services researchers, ” Eisenberg said, “we are interested in how public policy influences physicians' clinical decision making regarding their elderly patients—particularly policies that affect physicians' ability to prescribe or dispense pharmaceuticals.” As the nation forges a prescription drug policy, the authors urge that “drug benefits that are not neutral with regard to physicians' incentives to substitute medications for other therapies or to actually dispense medications should be implemented with caution because of the potentially negative impact on the doctor/patient relationship.” Lavizzo-Mourey and Eisenberg are both on the faculty of the University of Pennsylvania Medical School and are senior fellows at the University of Pennsylvania's Leonard Davis Institute of Health Economics. Lavizzo-Mourey, a clinically active geriatrician, received a medical degree from Harvard Medical School and a master of business administration degree from the Wharton School. She is affiliated with the Section of General Internal Medicine and the Center for the Study of Aging at the University of Pennsylvania. Eisenberg, an internist, received his medical degree from Washington University in St. Louis, Missouri, and holds a master of business administration degree from the Wharton School. He is chief of the Section of General Internal Medicine and Sol Katz Professor of General Internal Medicine at the University of Pennsylvania and is a member of the Physician Payment Review Commission. Both Lavizzo-Mourey and Eisenberg are alumni of The Robert Wood Johnson Foundation Clinical Scholars Program.

Innovations in medical curricula: templates for change?

Prologue: Today's new physicians are faced with an awesome array of often conflicting challenges: assimilating the vast and ever-increasing base of scientific knowledge, coping with societal concerns over the cost of medical care, dealing with ethical dilemmas surrounding life-sustaining technology, and recognizing the changing nature of the physician-patient relationship. To better equip physicians in training for the professional challenges that lie ahead, some medical schools have studied and experimented with innovations in curricula. In this article, the authors present a survey of the literature concerning medical school curricula innovations for the past ten years. The conclusion which emerges from this study is that “short-term programs not integrated into the medical school environment are not worth pursuing. A more radical restructuring of medical education is needed,” said Albert L. Siu, internist and Robert Wood Johnson Foundation Clinical Scholar at the University of California, Los Angeles (UCLA), In addition, Siu recommended that many of the innovations and experiments taking place in U.S. medical schools “need to be more agressively studied.” Coauthor S. Allison Mayer-Oakes is also an internist and Robert Wood Johnson Clinical Scholar at UCLA. Robert H. Brook is Senior Health Services Researcher at the Rand Corporation and professor of medicine and public health at UCLA. A member of the National Academy of Sciences' Institute of Medicine, Brook is well-known for his research in measurement of quality of care and was one of the original participants in the Clinical Scholars program. The authors are well equipped to discuss innovation in the medical school setting. UCLA's medical school has developed a number of innovative alternatives for young physicians in training and was an original site of the Johnson Foundations Clinical Scholars program, which has trained clinicians in the conduct of health services research.

An innovation in physician training: the Clinical Scholars Program.

The Robert Wood Johnson Foundation Clinical Scholars Program was developed to allow selected physician clinicians to acquire certain skills which are not part of the usual physician's repertoire. Begun in 1969 with support from the Carnegie Corporation and the Commonwealth Fund, funding has been provided since 1973 by the Robert Wood Johnson Foundation. By June 1981, 309 physicians had completed their training as clinical scholars, and a majority were pursuing careers in academic medicine. This paper recounts the factors and forces which led to the initiation and development of the program, its successes and failures, the problems faced, the achievements of clinical scholar alumni, and the program's current status.