Paul R. Marantz

Defining translational research: Implications for training

Because translational research is not clearly defined, developers of translational research programs are struggling to articulate specific program objectives, delineate the knowledge and skills (competencies) that trainees are expected to develop, create an appropriate curriculum, and track outcomes to assess whether program objectives and competency requirements are being met. Members of the Evaluation Committee of the Association for Clinical Research Training (ACRT) reviewed current definitions of translational research and proposed an operational definition to use in the educational framework. In this article, the authors posit that translational research fosters the multidirectional and multidisciplinary integration of basic research, patient-oriented research, and population-based research, with the long-term aim of improving the health of the public. The authors argue that the approach to designing and evaluating the success of translational training programs must therefore be flexible enough to accommodate the needs of individual institutions and individual trainees within the institutions but that it must also be rigorous enough to document that the program is meeting its short-, intermediate-, and long-term objectives and that its trainees are meeting preestablished competency requirements. A logic model is proposed for the evaluation of translational research programs.

A Call for Higher Standards of Evidence for Dietary Guidelines

Dietary guidelines, especially those designed to prevent the diseases of dietary excess, are a relatively new phenomenon in the United States. National dietary guidelines have been promulgated based on scientific reasoning and indirect evidence. In general, weak evidentiary support has been accepted as adequate justification for these guidelines. This low standard of evidence is based on several misconceptions, most importantly the belief that such guidelines could not cause harm. Using guidelines against dietary fat as a case in point, an analysis is provided that suggests that harm indeed may have been caused by the widespread dissemination of and adherence to these guidelines, through their contribution to the current epidemic of obesity and overweight in the U.S. An explanation is provided of what may have gone wrong in the development of dietary guidelines, and an alternative and more rigorous standard is proposed for evidentiary support, including the recommendation that when adequate evidence is not available, the best option may be to issue no guideline.

Lower standing systolic blood pressure as a predictor of falls in the elderly: a community-based prospective study

OBJECTIVES We investigated prospectively the relationships among falls, physical balance, and standing and supine blood pressure (BP) in elderly persons. BACKGROUND Falls occur often and adversely affect the activities of daily living in the elderly; however, their relationship to BP has not been clarified thoroughly. METHODS A total of 266 community-dwelling elderly persons age 65 years or over (123 men and 143 women, mean age of 76 years) were selected from among residents of Coop City, Bronx, New York. Balance was evaluated at baseline using computerized dynamic posturography (DPG). During a one-year follow-up, we collected information on subsequent falls on a monthly basis by postcard and telephone follow-up. RESULTS One or more falls occurred in 60 subjects (22%) during the one-year follow-up. Women fell more frequently than men (28% vs. 16%, p < 0.03), and fallers were younger than nonfallers. Fallers (n = 60) had lower systolic BP (SBP) levels when compared with nonfallers (n = 206) (128 +/- 17 vs. 137 +/- 22 mm Hg for standing, p < 0.006; 137 +/- 16 vs. 144 +/- 22 mm Hg for lying, p < 0.02), whereas diastolic BP was not related to falls. Falls occurred 2.8 times more often in the lower BP subgroup (<140 mm Hg for standing SBP) than in the higher BP subgroup (> or =140 mm Hg, p < 0.0003), and gender-related differences were observed (p = 0.006): 3.4 times for women (p < 0.0001) versus 1.9 times for men (p = 0.30). Loss of balance, as detected by DPG, did not predict future falls and was also not associated with baseline BP levels. Multiple logistic regression analysis demonstrated that female gender (relative risk [RR] = 2.1, p = 0.02), history of falls (RR = 2.5, p = 0.008) and lower standing SBP level (RR = 0.78 for 10 mm Hg increase, p = 0.005) were independent predictors of falls during one year of follow-up. CONCLUSIONS Lower standing SBP, even within normotensive ranges, was an independent predictor of falls in the community-dwelling elderly. Elderly women with a history of falls and with lower SBP levels should have more attention paid to the prevention of falls and related accidents.

Diagnostic heterogeneity in clinical trials for congestive heart failure

There are no uniform diagnostic criteria for congestive heart failure. To determine the pattern of diagnostic criteria used, reports of 51 randomized, double-blind, placebo-controlled, clinical drug trials published between 1977 and 1985 were reviewed. Only 23 (45%) of the trials specified objective diagnostic criteria beyond treatment history, clinical diagnosis, or functional class. Of these, there were two trials each for digoxin, hydralazine, amrinone, and metoprolol; for each pair, only one study showed therapy beneficial. Of the amrinone pair, the positive study required a lower ejection fraction (less than 30% compared with less than 45%) and selected patients with more clinical severity. Conversely, for metoprolol, the positive study specified a higher ejection fraction (less than 49% compared with less than 35%) and selected patients with clinically milder disease, suggesting that conflicting results may relate to differences in study population. Many studies of congestive heart failure are done without explicit diagnostic criteria. Criteria lack uniformity, and such discrepancies may explain conflicting results.

Diabetes and stress hyperglycemia associated with myocardial infarctions at an urban municipal hospital: Prevalence and effect on mortality

Municipal hospitals in large cities provide care for patients from immigrant and mixed ethnic communities that are at high risk for diabetes. Both diabetes and stress hyperglycemia increase the risk of adverse outcome after myocardial infarctions, and the impact of stress hyperglycemia on the outcome of myocardial infarctions in this particular setting has not been previously studied. We therefore undertook a retrospective cohort study to determine the prevalence of diabetes and stress hyperglycemia in patients presenting to a university-affiliated Bronx municipal hospital with myocardial infarction, and the relationship of these conditions to the extent of coronary disease and mortality. We obtained data on 106 consecutive patients from July 1998 to April 1999 with a diagnosis-related group diagnosis of either myocardial infarction or acute coronary syndrome, in which myocardial infarction was confirmed by serum enzymes or characteristic electrocardiographic changes. Patients were followed until March 30, 2001. Measurements of clinical parameters and results of catheterization were obtained for all patients. Death rates were determined by laboratory database, direct patient contact, or data from National Death Index. Eighty percent of the cohort had either a diagnosis of diabetes (n = 45, 42% of cohort) or evidence of stress hyperglycemia (defined as serum glucose greater than 126 mg/dL at the time of admission without prior diagnosis of diabetes, n = 40, 38%). In-hospital mortality for patients with diabetes, stress hyperglycemia, or normal glucose was 20%, 15%, and 14%, respectively. Eighty-three percent of the cohort received beta blockers, and 61% of hospital survivors had catheterization. Left main or triple vessel disease was common in both patients with diabetes (52%) and patients with stress hyperglycemia (32%). Mortality at follow up (maximum follow up 3 years; mean follow up 19.6 months) was much higher in patients with either diabetes (42%) or stress hyperglycemia (52%) than normal subjects (24%). Kaplan-Meier analysis of the difference in mortality between patients with high glucose on admission and normal subjects was borderline significant (P = 0.06). Multivariate regression demonstrated that age (P = 0.020), increase in admission serum creatinine (P = 0.001), and reduction in either ejection fraction (P = 0.016) or admission systolic blood pressure (P = 0.005) were significant predictors of mortality. Glycemic status and sex were not independently associated with death after controlling for these other factors. These results show that the prevalence of both diabetes and stress hyperglycemia on presentation with myocardial infarction is strikingly high in this immigrant, mixed ethnic, urban population. Patients with diabetes and stress hyperglycemia had advanced disease on presentation and much higher mortality at 2 to 3 years than those with normal blood glucose. The mortality difference is the result of older age and more advanced disease rather than hyperglycemia per se.

Using the case-discussion method to teach epidemiology and biostatistics.

Medical students must learn the principles of epidemiology and biostatistics to critically evaluate the medical literature. However, this subject has traditionally been difficult to teach. In 1997 at the Albert Einstein College of Medicine, the required first-year course in epidemiology and biostatistics was revised to use the case-discussion teaching method. In preparation for the course, experienced faculty participated in an intensive, two-day training workshop. The course, taught to 163 first-year medical students, was structured in two parts: (1) three lectures complemented by a detailed syllabus, followed by a multiple-choice midterm exam; and (2) six case-discussion seminars, followed by a short answer/essay final exam. There were seven case-discussion groups with 23–24 students each. The program was evaluated using subjective faculty feedback, examination scores, and student evaluation questionnaires. Faculty noted excellent student preparation and participation. Multiple-choice exam scores were comparable to those from earlier years, and a short answer/essay exam demonstrated good student mastery of the required material. Student evaluation was overwhelmingly positive, and significantly improved from prior years of the course. Positive student evaluations of the course using this teaching method continued over the next four years; National Board of Medical Examiners examination scores indicated success in mastery of the material; and student assessment of the course improved on the AAMC Graduation Questionnaire. This favorable experience suggests that case-discussion teaching can be employed successfully in teaching principles of epidemiology and biostatistics to medical students.

Implicit Bias and Its Relation to Health Disparities: A Teaching Program and Survey of Medical Students

Background: The varying treatment of different patients by the same physician are referred to as within provider disparities. These differences can contribute to health disparities and are thought to be the result of implicit bias due to unintentional, unconscious assumptions. Purposes: The purpose is to describe an educational intervention addressing both health disparities and physician implicit bias and the results of a subsequent survey exploring medical students’ attitudes and beliefs toward subconscious bias and health disparities. Methods: A single session within a larger required course was devoted to health disparities and the physicians potential to contribute to health disparities through implicit bias. Following the session the students were anonymously surveyed on their Implicit Association Test (IAT) results, their attitudes and experiences regarding the fairness of the health care system, and the potential impact of their own implicit bias. The students were categorized based on whether they disagreed (“deniers”) or agreed (“accepters”) with the statement “Unconscious bias might affect some of my clinical decisions or behaviors.” Data analysis focused specifically on factors associated with this perspective. Results: The survey response rate was at least 69%. Of the responders, 22% were “deniers” and 77% were “accepters.” Demographics between the two groups were not significantly different. Deniers were significantly more likely than accepters to report IAT results with implicit preferences toward self, to believe the IAT is invalid, and to believe that doctors and the health system provide equal care to all and were less likely to report having directly observed inequitable care. Conclusions: The recognition of bias cannot be taught in a single session. Our experience supports the value of teaching medical students to recognize their own implicit biases and develop skills to overcome them in each patient encounter, and in making this instruction part of the compulsory, longitudinal undergraduate medical curriculum.

Improving access to mammograms through community-based influenza clinics. A quasi-experimental study.

BACKGROUND It is a national priority to increase breast-cancer screening among women aged > or = 50. Annual influenza clinics may represent an efficient setting in which to promote breast-cancer screening among older women. To our knowledge, this possibility has not previously been explored. OBJECTIVE To examine whether offering women attending community-based influenza clinics the opportunity to receive a scheduling telephone call from a mammography facility will result in an increase in the number of mammograms performed over a 6-month period. METHODS We used a quasi-experimental design with 6-month follow-up. A contemporaneous population-based survey provided a further control group for comparison. The sample group consisted of a total of 284 women attending nine community-based influenza clinics in a semirural county in Connecticut. All women were aged > or = 50 and reported no mammogram in the preceding 12 months. All women received informational literature on mammography. Experimental subjects were each asked if a radiology facility chosen by the subject could call her at home to schedule a mammogram. Mammograms performed were determined by hospital record for participants who received a scheduling call from a radiology facility, and by self-report for all other participants. RESULTS Mammography use following access through influenza clinics was approximately twice that of women attending influenza clinics where access to mammography was not offered. Using three different assumptions regarding participants whose mammography status was unknown, the relative risks ranged between 1.6 and 2.1. For each assumption the results were statistically significant (chi(2)=8.51-12.2; p<0.001). CONCLUSIONS Linking access to mammography at community-based influenza clinics can significantly increase the use of mammograms among women aged > or = 50. Further studies should seek to confirm these findings and determine the degree to which they can be replicated in a variety of communities. Enhancing preventive health practice through the bundling of services suggests a new strategy to exploit available interventions to improve health.

The Internal Medicine Subinternship: A Curriculum Needs Assessment

Despite broad acceptance of the internal medicine subinternship rotation by the undergraduate medical education community, only a small fraction of programs provide students with explicit learning objectives. To design a curriculum for the medical subinternship, we surveyed 3 different groups of educational stakeholders—subinternship directors, residency program directors, and housestaff—in order to identify and prioritize the competencies that should be learned during this rotation. This study provides a starting point for the development of a structured curriculum for the fourth-year subinternship rotation.

Developing a multidisciplinary model of comparative effectiveness research within a clinical and translational science award.

The Clinical and Translational Science Awards (CTSAs) were initiated to improve the conduct and impact of the National Institutes of Healths research portfolio, transforming training programs and research infrastructure at academic institutions and creating a nationwide consortium. They provide a model for translating research across disciplines and offer an efficient and powerful platform for comparative effectiveness research (CER), an effort that has long struggled but enjoys renewed hope under health care reform. CTSAs include study design and methods expertise, informatics, and regulatory support; programs in education, training, and career development in domains central to CER; and programs in community engagement. Albert Einstein College of Medicine of Yeshiva University and Montefiore Medical Center have entered a formal partnership that places their CTSA at a critical intersection for clinical and translational research. Their CTSA leaders were asked to develop a strategy for enhancing CER activities, and in 2010 they developed a model that encompasses four broadly defined “compartments” of research strength that must be coordinated for this enterprise to succeed: evaluation and health services research, biobehavioral research and prevention, efficacy studies and clinical trials, and social science and implementation research. This article provides historical context for CER, elucidates Einstein-Montefiores CER model and strategic planning efforts, and illustrates how a CTSA can provide vision, leadership, coordination, and services to support an academic health centers collaborative efforts to develop a robust CER portfolio and thus contribute to the national effort to improve health and health care.