Robert Wood Johnson Clinical Scholars Research Articles

Registries and Selection Bias

Outcomes researchers share a strong interest in determining what is being achieved in practice. In the quest to reveal what is actually being done in medicine, we are often in a position to use existing data about clinical practice and patient experience to answer relevant questions, rather than having to generate data de novo. Patient registries, with their size, scope, and focus on patients who represent those seen in clinical practice, have become an increasingly common source of data for outcomes researchers. There is much to like about patient registries. These organized collections of data about clinical practice are a vehicle by which we can assemble massive amounts of information about patients and use it to assess quality of care, identify patterns of care, facilitate real-world research, and improve performance. In cardiovascular medicine, registries capture information about patients with acute coronary syndromes and heart failure as well as those who undergo procedures related to cardiac catheterization, percutaneous coronary intervention, carotid stents, and internal cardioverter defibrillators. Federal agencies are turning to registries to provide information about quality and produce insights about how to best practice medicine through an emphasis on comparative effectiveness research. Outcomes research articles based on registry data are numerous, including those from NRMI, CRUSADE, GWTG-HF, …

Medicine Should Be More Like Missouri

Missouri is the “Show Me” State. Although the origins of the term are uncertain, it seems that it might have been etched into the national consciousness during a speech by U.S. Congressman Willard Duncan Vandiver. In an 1899 speech he stated, “I come from a state that raises corn and cotton and cockleburs and Democrats, and frothy eloquence neither convinces nor satisfies me. I am from Missouri. You have got to show me.”1 The “Show Me” spirit is sometimes lacking in the field of Medicine, where we seem intent on integrating new tests and procedures before they are thoroughly vetted. Although we bemoan the slow adoption of effective treatments, we often prematurely adopt unproven strategies. Our quality measures are focused on underuse—the missed opportunity to provide a strongly indicated test or treatment. National registries, often industry-sponsored, also are commonly oriented toward addressing undertreatment, further fueling a national preoccupation on having not done enough rather than on having done too much. It is true that this emphasis on undertreatment has improved quality of care. In the mid-1990s, for example, only about half of the patients nationally, and in several states only about one-third, who were ideal candidates for β-blocker therapy after having survived an acute myocardial infarction were prescribed the medication. Ideal candidates were identified by careful chart reviews that determined a group with no documented absolute or relative contraindications.2 This pattern of care was described almost 15 years after clinical trials provided evidence of the benefit. Moreover, those who were treated had better survival, concordant with what would be expected based on the trials. Studies that revealed similarly stark patterns for the prescription of aspirin and angiotensin converting-enzyme inhibitors2–5 led to quality measures that tracked undertreatment, …

Quality Improvement

Outcomes research examines the effects of healthcare interventions and policies on health outcomes for individual patients and populations in routine practice, as opposed to the idealized setting of clinical trials. A national survey from 1998 to 2000 that evaluated the extent to which patients received established processes of care for 30 medical conditions illustrated the importance of outcomes research.1 Among adults living in 12 metropolitan areas in the United States, only half of patients received proven elements of preventive care, treatments for acute illness, and chronic disease management for which they were eligible. For cardiovascular conditions, the use of proven therapies varied widely from 68% to 25% of patients who received recommended care for coronary artery disease and atrial fibrillation, respectively.1 Despite these gaps between ideal and actual care, patient outcomes have improved in many fields. For instance, the age-adjusted mortality from cardiovascular disease in the United States fell by >40% from 1980 to 2000 as a result of improvements in risk factor modification and uptake of evidence-based treatments for coronary artery disease, myocardial infarction, and heart failure.2,3 Nevertheless, many Americans do not receive the ideal recommended care (either at all or in a timely fashion), whereas others receive too much or the wrong care.4,5 In the field of cardiovascular diseases, substantial opportunities for improvement remain. Outcomes research has generated a foundation of knowledge about what constitutes ideal care and what gaps exist between ideal and actual care, but we have less understanding about how to deliver this ideal care to every patient every day. The potential for basic science breakthroughs to reach and improve the health of individual patients and populations may be substantially delayed or may not be realized if science is not efficiently translated to action. Moreover, in many cases, increased delivery of …

The Development of Clinical Research Training: Past History and Current Trends in the United States

This article provides a brief account of the history of the development of training opportunities in clinical research in the United States. It highlights some developments in the clinical research enterprise since World War II and focuses examination on the involvement of the U.S. government and academic sector. Clinical research training is a relatively new academic field, and curricula in the design and conduct of clinical research have only emerged since the 1980s. The growing complexity of clinical trials and the emergence of evidence-based medicine in the last several decades created great demand for clinicians with knowledge of clinical epidemiology and biostatistics. Amidst alarm bells rung by physician-scientist leaders about the endangered species of clinical researchers, numerous proposals and solutions emerged to address these workforce and educational problems in the 1990s. Traditionally, physicians wishing to expand their education had to get a master's degree in public health or participate in unique programs such as the Robert Wood Johnson Clinical Scholars Program. Since the 1990s, the National Institutes of Health, through K awards, the Roadmap Initiative, and other funding mechanisms, has furnished tremendous support for the development of clinical research training opportunities from predoctoral immersion programs to degree-granting graduate programs. The author discusses key components of successful clinical research training programs and concludes with empirical recommendations for promoting careers in clinical research.

Questioning Conventional Wisdom

In science, what seems obvious may not be true, and what is accepted as conventional wisdom, may sometimes be based on flawed assumptions. What is more obvious than the fact that the sun revolves around the earth? Each day the sun rises in the eastern horizon, and we observe it moving across the sky until it retires in the west. And yet, it is not true that the earth is the center of the universe. Galileo de’ Galilei, the scientist born in Pisa, was persecuted for questioning such conventional wisdom and supporting the theory proposed by Nicolaus Copernicus of a heliocentric universe. Ultimately, the truth could not be suppressed. We have many examples of progress that resulted from the questioning of strongly held beliefs that once seemed so obvious. Who anticipated that a gastric ulcer could be considered an infectious disease?1 Who expected that drugs that effectively suppressed premature ventricular beats in patients with ischemic heart disease would cause harm?2 Who believed that treatment strategies associated with substantial risk reduction might be poorly adopted into practice even 10 years after the publication of the trials establishing their efficacy?3 Who could …

Teaching Community-Based Participatory Research Principles to Physicians Enrolled in a Health Services Research Fellowship

To improve health and reduce inequities through health services research, investigators are increasingly actively involving individuals and institutions who would be affected by the research. In one such approach, community-based participatory research (CBPR), community members participate in every aspect of designing and implementing research with the expectation that this process will enhance the translation of research into practice in communities. Because few physician researchers have expertise in such community-based approaches to research, the Robert Wood Johnson Foundation leadership expanded the mission of the Robert Wood Johnson Clinical Scholars Program (RWJCSP), which historically focused on health services and clinical research, to include training and mentored experiences in CBPR.The authors discuss the three years of experience (2005-2008) implementing the new community research curricula at the four RWJCSP sites: University of California, Los Angeles; University of Pennsylvania in Philadelphia; University of Michigan in Ann Arbor; and Yale University in New Haven. Three common goals and objectives are identified across sites: teaching the principles of CBPR, providing opportunities for conducting CBPR, and making an impact on the health of the communities served. Each site's different approaches to teaching CBPR based on the nature of the existing community and academic environments are described. The authors use illustrative quotes to exemplify three key challenges that training programs face when integrating community-partnered approaches into traditional research training: relationship building, balancing goals of education/scholarship/relationships/product, and sustainability. Finally, the authors offer insights and implications for those who may wish to integrate CBPR training into their research training curricula.

Public Reporting of 30-Day Mortality for Patients Hospitalized With Acute Myocardial Infarction and Heart Failure

For cardiac care, the Centers for Medicare M how often smokers are counseled to quit; how rapidly hospitals provide reperfusion therapy for patients with an ST-segment elevation myocardial infarction; and how often the ejection fraction is measured for patients with heart failure. All of these measures assess care that is strongly recommended by guidelines. The measures include only those patients who should receive this care and are reported at the hospital level simply as percentages. The performance on these measures should ideally be 100%, and the rates have improved markedly over time. ; View this table: Table. Acute Myocardial Infarction and Heart Failure Process-of-Care Measures On June 21, 2007, CMS expanded the measures to include outcomes and posted information on its “Hospital Compare” website1 regarding hospital-specific 30-day mortality rates for patients with acute myocardial infarction and heart failure. These measures used administrative claims data and were validated against measures using medical record data; the measures were approved by the National Quality Forum.2,3 In 2007, the publicly reported information was limited to describing hospitals as having rates that were higher, lower, or no different than the national average. Hospitals received information about their rates, their patients, and comparisons with other hospitals in their state and with the nation. This year, CMS is expanding the publicly available information. For acute myocardial infarction, heart failure, and now pneumonia, CMS will post the calculated risk-standardized 30-day mortality rates (RSMRs) and the 95% interval estimates for each hospital that treated Medicare patients with these conditions; hospital volume for each condition also will be posted. As …

Seeking Better Outcomes in Coronary Artery Bypass Grafting

Are we delivering the safest and most effective care? How best can we learn from our experience? For healthcare professionals who ask these questions, the article by Guru and colleagues in this issue of Circulation is essential reading.1 These Canadian investigators performed an implicit review and retrospective analysis of 347 randomly selected in-hospital deaths after coronary artery bypass grafting (CABG) surgery and determined that approximately one third might have been prevented by better care. The study offers many important lessons with implications far beyond cardiac surgery. Article p 2969 Guru and colleagues uncovered many opportunities for important improvements in a hospital system that could have been content with its successes. Their investigation was conducted in a system with no low-volume hospitals and low risk-adjusted mortality rates and involved the participation of experienced staff surgeons and division chiefs. They found remarkably high percentages of preventable deaths, defined as deaths that could have been avoided had optimal care been delivered. Optimal care was considered to be the best possible care that could be delivered if current resources were operating at peak performance in accordance with the best available evidence at the time of the hospital admission. The investigators found that as many as 107 preventable CABG-related deaths occurred in Ontario in fiscal year 2000 to 2001. These deaths occurred in every institution. In particular, the highest percentages of preventable deaths were not clustered at the institutions with the highest risk-adjusted mortality rates, indicating that even a low mortality rate should not beget complacency. Even in the hospital with the lowest risk-adjusted mortality rate, about 20% of deaths were deemed to be preventable. Guru and colleagues focused specifically on contributing causes of deaths that may have been prevented. In this way, many deaths had more than 1 potential contributing cause. In each …

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...

Robert Wood Johnson Clinical Scholars Mark 35 Years of Health Services Research

ON THE ROAD TO A REWARDING career after his residency, Ben Springgate, MD, MPH, wanted to find the intersection of health care, health policy, and health disparities. Without a traditional map to show the way, Springgate’s compass pointed to the University of California, Los Angeles, School of Medicine (UCLA), which serves as one of four academic training sites for the Robert Wood Johnson (RWJ) Clinical Scholars Program. As a clinical scholar, Springgate hoped to build on work he had done as a medical student and resident at Tulane University School of Medicine in developing clinical programs for the homeless of New Orleans. But just as he started at UCLA in summer 2005, Hurricane Katrina struck and created an unprecedented intensive program for providing health care for the homeless. “Suddenly, everyone I knew was homeless,” says Springgate, a native of New Orleans. A few days after the storm hammered the Gulf Coast, he was on his way back to Louisiana with the blessing of his mentors in the scholars program.

ALZHEIMER'S DISEASE MEDICATION: USE AND COST PROJECTIONS FOR MEDICARE PART D

ALZHEIMER'S DISEASE MEDICATION: USE AND COST PROJECTIONS FOR MEDICARE PART D

Strategies for Academic and Clinician Engagement in Community-Participatory Partnered Research

THERE HAVE BEEN RECENT PRACTICE AND POLICY CONcerns over the “quality chasm,” or gap between the promise of evidence-based medicine and the realities of community practice with little variation by geographic and sociodemographic factors. Studies document disparities in access of care for particular conditions, and there is widespread concern about disparities in health status and health risk factors disadvantaging underserved ethnic minority and lower-socioeconomic status groups. Addressing quality gaps and health disparities will require implementation of programs to address social determinants of health and improve services delivery across diverse communities. Doing so for underserved communities may be especially challenging owing to resource constraints, underdevelopment of research, and historical distrust in research and health care in some groups. Experts recommend promoting public participation and engagement of diverse communities in research as a strategy to enhance its relevance and to address disparities more effectively Community-based participatory research (CBPR) is the prevailing paradigm to facilitate these goals by promoting mutual transfer of expertise and power sharing in decision making and data ownership across community and academic partners. A recent review identified relatively few English-language CBPR studies in health but wide variation in extent and type of participation. Community-based participatory research has been used more as a paradigm for public health than for clinical or health services research. Many features of CBPR—such as spending time in the community, power sharing, and action research methods—might challenge physicians, given their clinical training that often requires interactions under time pressure, the hierarchical structure of academic medicine, and the focus of medical research on controlled trials as the standard for evidence. However, opportunities (such as the recent National Institutes of Health announcement for CBPR research [http://grants.nih.gov/grants /guide/pa-files/PAR-07-004.html]) are emerging for conducting CBPR in substantive areas for which physician leadership could be helpful. It is timely to familiarize clinical investigators with principles of participatory research and to offer strategies to build effective research partnerships that facilitate clinician leadership in efforts to improve health for all communities. Over several years, we collaborated in exploring ways of blending concepts and approaches from clinical services research and CBPR in research initiatives, research training of physicians in the Robert Wood Johnson Clinical Scholars Program (http://www.hsrcenter.ucla.edu/csp), and a multicenter effort to develop infrastructure to support community-based research. This approach is based on community-partnered participatory research (CPPR), a form of CBPR developed by Healthy African American Families and Charles R. Drew Medical University with support from the Centers for Disease Control and Prevention (CDC), that emphasizes authentic community-academic partnerships as distinct from many collaborative research activities conducted at community sites without partnership in design, implementation, or product ownership. In collaboration with Keith Norris and Paul Koegel, we blended this model with methods from services research initiatives, such as Partners in Care, that addressed quality disparities. Communitypartnered participatory research promotes equal community and academic partnership and power sharing in all phases of research, grounded in evidence-based practice as defined from academic and community perspectives, a framing of CBPR that is suited to physician coleadership. This Commentary provides lessons learned from these applications. Recent examples are available at http://www .communitytrial.org. Many components of CPPR are partly based on CBPR models but are organized into a particular approach.

Defining, navigating, and negotiating success

Background: We studied female graduates of the Robert Wood Johnson Clinical Scholars Program (CSP, Class of 1984 to 1989) to explore and describe the complexity of creating balance in the life of mid-career academic woman physicians.

Psychiatrist Urges Public-Health Focus To Eliminate Barriers to Care

Psychiatrist Urges Public-Health Focus To Eliminate Barriers to Care

Defining, Navigating, and Negotiating Success: The Experiences of Mid-Career Robert Wood Johnson Clinical Scholar Women

We studied female graduates of the Robert Wood Johnson Clinical Scholars Program (CSP, Class of 1984 to 1989) to explore and describe the complexity of creating balance in the life of mid-career academic woman physicians. We conducted and qualitatively analyzed (kappa 0.35 to 1.0 for theme identification among rater pairs) data from a semi-structured survey of 21 women and obtained their curricula vitae to quantify publications and grant support, measures of academic productivity. Sixteen of 21 (76%) women completed the survey. Mean age was 48 (range: 45 to 56). Three were full professors, 10 were associate professors, and 3 had left academic medicine. Eleven women had had children (mean 2.4; range: 1 to 3) and 3 worked part-time. From these data, the conceptual model expands on 3 key themes: (1) defining, navigating, and negotiating success, (2) making life work, and (3) making work work. The women who described themselves as satisfied with their careers (10/16) had clarity of values and goals and a sense of control over their time. Those less satisfied with their careers (6/16) emphasized the personal and professional costs of the struggle to balance their lives and described explicit institutional barriers to fulfillment of their potential. For this group of fellowship-prepared academic women physicians satisfaction is achieving professional and personal balance.

Free Lunch?

Back to table of contents Previous article Next article EditorialFull AccessFree Lunch?Kevin P. Hill M.D.Kevin P. Hill M.D.Search for more papers by this authorPublished Online:1 Apr 2006AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinked InEmail “Dr. Hill, are we changing my medicine because they gave you a pen?”Iwas moments away from offering an explanation of drug half-lives when my patient’s eyes brightened and she asked the question that jolted me. This 47-year-old psychopharmacology clinic patient at times seemed slow to follow the logic of our treatment plan, but this question about her antianxiety medication came swiftly. My cheeks and forehead were suddenly awash with warmth as I looked down and saw my pen did indeed announce the availability of a popular benzodiazepine in a new formulation. At that moment I felt bought and paid for.My stance on the influence of drug lunches changed over the course of my psychiatry residency. At the beginning, I thought I could slide a pen into my pocket or grab a few slices of pizza without my behavior being affected. So did most of my colleagues, who eagerly engaged in small talk with drug representatives (“reps”) in order to claim another mug or pocket pharmacopoeia. We wondered when the reps who brought the tasty pad thai would be back, joking that we could not recall the company for which they worked. However, some of my fellow residents refused to eat the free drug company lunch right from the start. I scoffed at them, for I thought I could save a few bucks on lunch and still choose medications for my patients in an unbiased manner. A wealth of research has shown my initial response to the free lunches was typical for many doctors (1 , 2) . I drew a flexible line between reasonable gifts—pens, simple lunches of sandwiches or pizza—and those gifts I thought too extravagant to accept—dinners at the most expensive restaurants in town. I was amazed at the number of brightly colored invitations to listen to an expert extol the merits of new drugs over dinner at restaurants I could not afford on my resident’s salary. While it was difficult to pass up five-star dinners, I was comfortable with my self-imposed standard for the first 3 years of my residency. I did notice, however, that each time events were held at a fancy French restaurant written up in the paper, the lectures seemed especially pertinent to me. My position on drug companies and their gifts continued to evolve during my fourth year of residency. I recalled the uncomfortable feelings caused by patients like my psychopharmacology clinic attendee, and with a little more free time on my hands in my final year of training, I decided to read about the pharmaceutical industry’s influence on medicine. Even gifts of negligible value can alter the behavior of doctors in ways we are not always aware (3) . And while peer-reviewed research studies can make a strong impact upon the way we as doctors practice medicine, and drug companies have collaborated with psychiatric investigators on some important studies, implementing a study’s findings is a matter of choice. Although listening to descriptions of recent studies while sipping hot coffee brought into the clinic by drug representatives is more convenient than reading journals on your own, one consequence may be that too large a fraction of one’s knowledge of new research and its application to practice is heavily filtered and arguably biased. With my residency training at Brigham and Women’s Hospital now completed, I reflect upon the array of topics I have learned, from psychodynamic psychotherapy to opioid detoxification. Few, however, are as complex as the issue of drug company influence on training and practice. As a result of my experiences, my pens are no longer emblazoned with the latest medications, and I bring my lunch from home.But my eyes still do linger on the pad thai.Address correspondence and reprint requests to Dr. Hill, Robert Wood Johnson Clinical Scholars Program, Yale University School of Medicine, 333 Cedar St., P.O. Box 208088, IE-61SHM, New Haven, CT 06520-8088; [email protected] (e-mail).

Challenges in the development of pediatric health services research

Challenges in the development of pediatric health services research

PROSPECTIVE ASSESSMENT OF PATIENT REPORTED URINARY CONTINENCE AFTER RADICAL PROSTATECTOMY

PROSPECTIVE ASSESSMENT OF PATIENT REPORTED URINARY CONTINENCE AFTER RADICAL PROSTATECTOMY

Point of View: The Epidemiology of Low Back Pain in the Rest of the World

Professor, Departments of Medicine and Health Services Co-Director, Center for Cost and Outcomes Research Head, University Section of General Internal Medicine Co-Director, Robert Wood Johnson Clinical Scholars Program University of Washington, Seattle, Washington

Doxycycline Compared With Azithromycin for Treating Women With Genital Chlamydia trachomatis Infections

Robert Wood Johnson Clinical Scholars Program, University of Washington, Seattle, Washington; Denver Department of Health, Denver, Colorado; University of Pennsylvania, Philadelphia, Pennsylvania. Ann Intern Med 1996;124:389-399