Costs and inconsistencies in US IRB review of low-risk medical education research.

CONTEXT: Advances in communication technologies over the last two decades have transformed the way medical education research is conducted, creating opportunities for multi-institution national and international studies. Although these studies enable researchers to gain broader understandings of educational processes across institutions, they increase the need for multiple institutional review board (IRB) reviews to ensure the protection of human subjects. OBJECTIVES: This study describes the process of obtaining multiple IRB approvals of the same protocol for a multi-site, low-risk, medical education research project in the USA. The burden of obtaining those reviews and their consistency are assessed. The associated time and costs, and implications for the research process are detailed. METHODS: Following review by the investigators' parent institution IRB, the project team circulated a uniform protocol for conduct of a low-risk, medical education survey to the IRBs of 89 US medical schools for review. The processes and time required to obtain approvals were recorded to estimate associated research team personnel costs. RESULTS: Approval could not be obtained from five IRBs as a result of insurmountable procedural barriers. A total of 67 IRBs eventually deferred to the parent IRB determination. The remaining IRBs required a variety of additional procedural processes before ultimately agreeing with the original determination. The personnel costs associated with obtaining the 84 approvals amounted to US$121,344. CONCLUSIONS: Considering the value of multi-site designs to address a range of research questions, enhance participant diversity and develop representative findings, solutions must be found to counter inefficiencies of current IRB review processes for low-risk research, such as that usually conducted in medical education. Although we acknowledge that local review is an essential protective measure for research involving identifiable communities that are uniquely susceptible to social or economic harm, this report suggests that proposals to modernise and streamline IRB review processes for low-risk research are timely and relevant.

Racial, gender, and socioeconomic status bias in senior medical student clinical decision-making: a national survey.

BACKGROUND: Research suggests stereotyping by clinicians as one contributor to racial and gender-based health disparities. It is necessary to understand the origins of such biases before interventions can be developed to eliminate them. As a first step toward this understanding, we tested for the presence of bias in senior medical students. OBJECTIVE: The purpose of the study was to determine whether bias based on race, gender, or socioeconomic status influenced clinical decision-making among medical students. DESIGN: We surveyed seniors at 84 medical schools, who were required to choose between two clinically equivalent management options for a set of cardiac patient vignettes. We examined variations in student recommendations based on patient race, gender, and socioeconomic status. PARTICIPANTS: The study included senior medical students. MAIN MEASURES: We investigated the percentage of students selecting cardiac procedural options for vignette patients, analyzed by patient race, gender, and socioeconomic status. KEY RESULTS: Among 4,603 returned surveys, we found no evidence in the overall sample supporting racial or gender bias in student clinical decision-making. Students were slightly more likely to recommend cardiac procedural options for black (43.9 %) vs. white (42 %, p = .03) patients; there was no difference by patient gender. Patient socioeconomic status was the strongest predictor of student recommendations, with patients described as having the highest socioeconomic status most likely to receive procedural care recommendations (50.3 % vs. 43.2 % for those in the lowest socioeconomic status group, p < .001). Analysis by subgroup, however, showed significant regional geographic variation in the influence of patient race and gender on decision-making. Multilevel analysis showed that white female patients were least likely to receive procedural recommendations. CONCLUSIONS: In the sample as a whole, we found no evidence of racial or gender bias in student clinical decision-making. However, we did find evidence of bias with regard to the influence of patient socioeconomic status, geographic variations, and the influence of interactions between patient race and gender on student recommendations.

MyPreventiveCare: implementation and dissemination of an interactive preventive health record in three practice-based research networks serving disadvantaged patients--a randomized cluster trial.

BACKGROUND: Evidence-based preventive services for early detection of cancer and other health conditions offer profound health benefits, yet Americans receive only half of indicated services. Policy initiatives promote the adoption of information technologies to engage patients in care. We developed a theory-driven interactive preventive health record (IPHR) to engage patients in health promotion. The model defines five levels of functionality: (1) collecting patient information, (2) integrating with electronic health records (EHRs), (3) translating information into lay language, (4) providing individualized, guideline-based clinical recommendations, and (5) facilitating patient action. It is hypothesized that personal health records (PHRs) with these higher levels of functionality will inform and activate patients in ways that simpler PHRs cannot. However, realizing this vision requires both technological advances and effective implementation based upon clinician and practice engagement. METHODS/DESIGN: We are starting a two-phase, mixed-method trial to evaluate whether the IPHR is scalable across a large number of practices and how its uptake differs for minority and disadvantaged patients. In phase 1, 40 practices from three practice-based research networks will be randomized to add IPHR functionality to their PHR versus continue to use their existing PHR. Throughout the study, we will engage intervention practices to locally tailor IPHR content and learn how to integrate new functions into their practice workflow. In phase 2, the IPHR to all nonintervention practices to observe whether the IPHR can be implemented more broadly (Scalability). Phase 1 will feature an implementation assessment in intervention practices, based on the RE-AIM model, to measure Reach (creation of IPHR accounts by patients), Adoption (practice decision to use the IPHR), Implementation (consistency, fidelity, barriers, and facilitators of use), and Maintenance (sustained use). The incremental effect of the IPHR on receipt of cancer screening tests and shared decision-making compared to traditional PHRs will assess Effectiveness. In phase 2, we will assess similar outcomes as phase 1 except for effectiveness. DISCUSSION: This study will yield information about the effectiveness of new health information technologies designed to actively engage patients in their care as well as information about how to effectively implement and disseminate PHRs by engaging clinicians. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02138448.

Student specialty plans, clinical decision making, and health care reform.

BACKGROUND AND OBJECTIVES: Health care reform aims to increase evidence-based, cost-conscious, and patient-centered care. Family medicine is seen as central to these aims in part due to evidence of lower cost and comparable quality care compared with other specialties. We sought evidence that senior medical students planning family medicine residency differ from peers entering other fields in decision-making patterns relevant to these health care reform aims. METHODS: We conducted a national, anonymous, internet-based survey of senior medical students. Students chose one of two equivalent management options for a set of patient vignettes based on preventive care, medication selection, or initial chronic disease management scenarios, representing in turn evidence-based care, cost-conscious care, and patient-centered care. We examined differences in student recommendations, comparing those planning to enter family medicine with all others using bivariate and weighted, multilevel, multivariable analyses. RESULTS: Among 4,656 surveys received from seniors at 84 participating medical schools, students entering family medicine were significantly more likely to recommend patient management options that were more cost conscious and more patient centered. We did not find a significant difference between the student groups in recommendations for evidence-based care vignettes. CONCLUSIONS: This study provides preliminary evidence suggesting that students planning to enter family medicine may already have clinical decision-making patterns that support health care reform goals to a greater extent than their peers. If confirmed by additional studies, this could have implications for medical school admission and training processes.