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Biomedical subjects

Joel S Weissman

Publications and source records attributed to Joel S Weissman.

At least 19 recordsLinked to original sources

Financial relationships between institutional review board members and industry.

BACKGROUND: Little is known about the nature, extent, and consequences of financial relationships between industry and institutional review board (IRB) members in academic institutions. We surveyed IRB members about such relationships. METHODS: We surveyed a random sample of 893 IRB members at 100 academic institutions (response rate, 67.2%). The questionnaire focused on the financial relationships that the members had with industry (e.g., employment, membership on boards, consulting, receipt of royalties, and paid speaking). RESULTS: We found that 36% of IRB members had had at least one relationship with industry in the past year. Of the respondents, 85.5% said they never thought that the relationships that another IRB member had with industry affected his or her IRB-related decisions in an inappropriate way, 11.9% said they thought this occurred rarely, 2.4% thought it occurred sometimes, and 0.2% thought it occurred often. Seventy-eight respondents (15.1%) reported that at least one protocol came before their IRB during the previous year that was sponsored either by a company with which they had a relationship or by a competitor of that company, both of which could be considered conflicts of interest. Of these 78 members (62 voting members and 16 nonvoting members), 57.7% reported that they always disclosed the relationship to an IRB official, 7.7% said they sometimes did, 11.5% said they rarely did, and 23.1% said they never did. Of the 62 voting members who reported conflicts, 64.5% reported that they never voted on the protocol, 4.8% said they rarely did, 11.3% said they sometimes did, and 19.4% said they always did. Most respondents reported that the views of IRB members who had experience working with industry were beneficial in reviewing industry-sponsored protocols. CONCLUSIONS: Relationships between IRB members and industry are common, and members sometimes participate in decisions about protocols sponsored by companies with which they have a financial relationship. Current regulations and policies should be examined to be sure that there is an appropriate way to handle conflicts of interest stemming from relationships with industry.

Biomedical Research↗

Barriers to repeat mammography: cultural perspectives of African-American, Asian, and Hispanic women.

Women of minority races and ethnicities have lower mammography return rates compared to Caucasians. To better understand barriers to mammography, we conducted six focus groups with 49 women of minority races and ethnicities (19 Asian, 16 African-American, and 14 Hispanic) recruited from outpatient medical clinics in Boston. Eligible women had at least one prior mammogram and no personal history of cancer. Discussions were recorded and transcribed, and thematic content analyses were performed. African-Americans and Hispanics felt that lack of insurance was not a barrier to mammography as they were aware of free programs. Some African-Americans avoided mammograms because they were fatalistic and believed that a breast cancer diagnosis would inevitably lead to death. African-Americans agreed that social issues, such as drug and domestic abuse, made obtaining preventive health care less important. Asian participants agreed that mammogram return rates were poor because appointments took time away from work. Asian and Hispanic women identified discourteous behavior by hospital staff as a barrier. Cultural barriers to repeat mammography appear to vary among different racial groups. Interventions to improve screening among minority populations may be more successful if they address group-specific concerns.

Adult↗

The educational impact of ACGME limits on resident and fellow duty hours: a pre-post survey study.

PURPOSE: To assess the educational impact of Accreditation Council for Graduate Medical Education resident work-hour limits implemented in July 2003. METHOD: All trainees in all 76 accredited programs at two large teaching hospitals were surveyed between May and June 2003 (before work-hour reductions) and then between May and June 2004 (after work-hour reductions) about hours, education, and fatigue. Based on changes in weekly duty hours, 13 programs experiencing substantial reduction in hours were classified into a reduced-hours group. Differences in assessments of educational endpoints before and after policy implementation by trainees in the reduced-hours group were compared with those in other programs to control for potential temporal trends, using two-way ANOVA with interaction. RESULTS: The number of respondents was 1,770 (60% response rate). The reduced-hours group reported a significant decrease in time spent directly caring for patients (from 48.5 to 42.3 mean h/wk, P = 0.03), but the volume of important clinical experiences, including procedures, was preserved, as was the sense of clinical preparedness. On 22 questions related to educational quality and adequacy, only three differences in differences were significant, with the reduced-hours group reporting a relative increase in opportunities for research, decrease in quality of faculty teaching, and decrease in educational satisfaction. The percentage of trainees reporting frequent negative effects of fatigue dropped more in the reduced-hours programs than in the other programs (P < 0.05). CONCLUSION: This study shows that it may be possible to reduce residents' hours--and the perceived adverse impact of fatigue--while generally preserving the self-assessed quality, quantity, and outcomes of graduate medical education.

Analysis of Variance↗

Resident physicians' preparedness to provide cross-cultural care.

CONTEXT: Two recent reports from the Institute of Medicine cited cross-cultural training as a mechanism to address racial and ethnic disparities in health care, but little is known about residents' educational experience in this area. OBJECTIVE: To assess residents' attitudes about cross-cultural care, perceptions of their preparedness to deliver quality care to diverse patient populations, and educational experiences and educational climate regarding cross-cultural training. DESIGN, SETTING, AND PARTICIPANTS: A survey was mailed in the winter of 2003 to a stratified random sample of 3435 resident physicians in their final year of training in emergency medicine, family practice, internal medicine, obstetrics/gynecology, pediatrics, psychiatry, or general surgery at US academic health centers. RESULTS: Responses were obtained from 2047 (60%) of the sample. Virtually all (96%) of the residents indicated that it was moderately or very important to address cultural issues when providing care. The number of respondents who indicated that they believed they were not prepared to care for diverse cultures in a general sense was only 8%. However, a larger percentage of respondents believed they were not prepared to provide specific components of cross-cultural care, including caring for patients with health beliefs at odds with Western medicine (25%), new immigrants (25%), and patients whose religious beliefs affect treatment (20%). In addition, 24% indicated that they lacked the skills to identify relevant cultural customs that impact medical care. In contrast, only a small percentage of respondents (1%-2%) indicated that they were not prepared to treat clinical conditions or perform procedures common in their specialty. Approximately one third to half of the respondents reported receiving little or no instruction in specific areas of cross-cultural care beyond what was learned in medical school. Forty-one percent (family medicine) to 83% (surgery and obstetrics/gynecology) of respondents reported receiving little or no evaluation in cross-cultural care during their residencies. Barriers to delivering cross-cultural care included lack of time (58%) and lack of role models (31%). CONCLUSIONS: Resident physicians' self-reported preparedness to deliver cross-cultural care lags well behind preparedness in other clinical and technical areas. Although cross-cultural care was perceived to be important, there was little clinical time allotted during residency to address cultural issues, and there was little training, formal evaluation, or role modeling. These mixed educational messages indicate the need for significant improvement in cross-cultural education to help eliminate racial and ethnic disparities in health care.

Adult↗

Error reporting and disclosure systems: views from hospital leaders.

CONTEXT: The Institute of Medicine has recommended establishing mandatory error reporting systems for hospitals and other health settings. OBJECTIVE: To examine the opinions and experiences of hospital leaders with state reporting systems. DESIGN AND SETTING: Survey of chief executive and chief operating officers (CEOs/COOs) from randomly selected hospitals in 2 states with mandatory reporting and public disclosure, 2 states with mandatory reporting without public disclosure, and 2 states without mandatory systems in 2002-2003. MAIN OUTCOME MEASURES: Perceptions of the effects of mandatory systems on error reporting, likelihood of lawsuits, and overall patient safety; attitudes regarding release of incident reports to the public; and likelihood of reporting incidents to the state or to the affected patient based on hypothetical clinical vignettes that varied the type and severity of patient injury. RESULTS: Responses were received from 203 of 320 hospitals (response rate = 63%). Most CEOs/COOs thought that a mandatory, nonconfidential system would discourage reporting of patient safety incidents to their hospital's own internal reporting system (69%) and encourage lawsuits (79%) while having no effect or a negative effect on patient safety (73%). More than 80% felt that the names of both the hospital and the involved professionals should be kept confidential, although respondents from states with mandatory public disclosure systems were more willing than respondents from the other states to release the hospital name (22% vs 4%-6%, P = .005). Based on the vignettes, more than 90% of hospital leaders said their hospital would report incidents involving serious injury to the state, but far fewer would report moderate or minor injuries, even when the incident was of sufficient consequence that they would tell the affected patient or family. CONCLUSIONS: Most hospital leaders expressed substantial concerns about the impact of mandatory, nonconfidential reporting systems on hospital internal reporting, lawsuits, and overall patient safety. While hospital leaders generally favor disclosure of patient safety incidents to involved patients, fewer would disclose incidents involving moderate or minor injury to state reporting systems.

Attitude of Health Personnel↗

Social disparities in cancer: lessons from a multidisciplinary workshop.

The problem of social disparities in cancer continues to challenge health care researchers. This article summarizes the themes and lessons emerging from a 2004 workshop that convened researchers from academic and government venues to review and discuss the extant literature, and to develop new conceptual frameworks for future investigations. Workshop participants explored the factors that contribute to social inequalities in cancer in the U.S. including the relative contributions of race and racism, the independent contributions of socioeconomic position, insurance, and access to care. Noting the heterogeneous patterns of inequality across cancer types, the multiple underlying causes of disparities, and the role of the health care system itself, the authors call for an organized program of multidisciplinary research.

Delivery of Health Care↗

Mixed messages: residents' experiences learning cross-cultural care.

PURPOSE: An Institute of Medicine report issued in 2002 cited cross-cultural training as a mechanism to address racial and ethnic disparities in health care, but little is known about residents' training and capabilities to provide quality care to diverse populations. This article explores a select group of residents' perceptions of their preparedness to deliver quality care to diverse populations. METHOD: Seven focus groups and ten individual interviews were conducted with 68 residents in locations nationwide. Qualitative analysis of focus-group and individual interview transcripts was performed to assess residents' perceptions of (1) preparedness to deliver care to diverse patients; (2) educational climate; and (3) training experiences. RESULTS: Most residents in this study noted the importance of cross-cultural care yet reported little formal training in this area. Residents wanted more formal training yet expressed concern that culture-specific training could lead to stereotyping. Most residents had developed ad hoc, informal skills to care for diverse patients. Although residents perceived institutional endorsement, they sensed it was a low priority due to lack of time and resources. CONCLUSIONS: Residents in this study reported receiving mixed messages about cross-cultural care. They were told it is important, yet they received little formal training and did not have time to treat diverse patients in a culturally sensitive manner. As a result, many developed coping behaviors rather than skills based on formally taught best practices. Training environments need to increase training to enhance residents' preparedness to deliver high-quality cross-cultural care if the medical profession is to achieve the goals set by the Institute of Medicine.

Adult↗

The who, what, and why of risk adjustment: a technology on the cusp of adoption.

Risk adjustment (RA) consists of a series of techniques that account for the health status of patients when predicting or explaining costs of health care for defined populations or for evaluating retrospectively the performance of providers who care for them. Although the federal government seems to have settled on an approach to RA for Medicare Advantage programs, adoption and implementation of RA techniques elsewhere have proceeded much more slowly than was anticipated. This article examines factors affecting the adoption and use of RA outside the Medicare program using case studies in six U.S. health care markets (Baltimore, Seattle, Denver, Cleveland, Phoenix, and Atlanta) as of 2001. We found that for purchasing decisions, RA was used exclusively by public agencies. In the private sector, use of risk adjustment was uncommon and scattered and assumed informal and unexpected forms. The most common private sector use of RA was by health plans, which occasionally employed RA in negotiations with purchasers or to allocate resources internally among providers. The article uses classic technology diffusion theory to explain the adoption and use of RA in these six markets and derives lessons for health policy generally and for the future of RA in particular. For health policy generally, the differing experiences of public and private actors with RA serve as markers of the divergent paths that public and private health care sectors are pursuing with respect to managed care and risk sharing. For the future of RA in particular, its history suggests the need for health service researchers to consider barriers to use adoption and new analytic technologies as they develop them.

Diffusion of Innovation↗

When methods meet politics: how risk adjustment became part of Medicare managed care.

Health-based risk adjustment has long been touted as key to the success of competitive models of health care. Because it decreases the incentive to enroll only healthy patients in insurance plans, risk adjustment was incorporated into Medicare policy via the Balanced Budget Act of 1997. However, full implementation of risk adjustment was delayed due to clashes with the managed care industry over payment policy, concerns over perverse incentives, and problems of data burden. We review the history of risk adjustment leading up to the Balanced Budget Act and examine the controversies surrounding attempts to stop or delay its implementation during the years that followed. The article provides lessons for the future of health-based risk adjustment and possible alternatives.

Centers for Medicare and Medicaid Services, U.S.↗

Methodological issues in measuring health disparities.

OBJECTIVES: This report discusses six issues that affect the measurement of disparities in health between groups in a population: Selecting a reference point from which to measure disparity. Measuring disparity in absolute or in relative terms. Measuring in terms of favorable or adverse events. Measuring in pair-wise or in summary fashion. Choosing whether to weight groups according to group size. Deciding whether to consider any inherent ordering of the groups. These issues represent choices that are made when disparities are measured. METHODS: Examples are used to highlight how these choices affect specific measures of disparity. RESULTS: These choices can affect the size and direction of disparities measured at a point in time and conclusions about the size and direction of changes in disparity over time. Eleven guidelines for measuring disparities are presented. CONCLUSIONS: Choices concerning the measurement of disparity should be made deliberately, recognizing that each choice will affect the results. When results are presented, the choices on which the measurements are based should be described clearly and justified appropriately.

Data Collection↗

Disparity in use of orthotopic liver transplantation among blacks and whites.

Orthotopic liver transplantation (OLT) is the best treatment for end-stage liver disease. Limited data exist on the access of minorities to OLT. The aim of this study was to determine whether disparities exist among black and white OLT patients. Data were collected from the United Network for Organ Sharing on black and white 18-70 year-old OLT waiting list registrants (n = 29,013) and OLT recipients (n = 15,805) between 1994 and 1998. Standardized transplant ratios were generated by comparing the racial distribution of OLT patients with the US population. Demographic and clinical characteristics of OLT registrants were compared by race. Multivariate analyses were performed to identify predictors of time to OLT and the likelihood of dying or receiving OLT within 4 years, controlling for severity of illness and other factors. The standardized transplant ratio for black OLT recipients (0.65) was significantly lower than the standardized transplant ratio for white OLT recipients (1.05). Blacks were younger and sicker than whites. After adjustment for severity and other factors, time to OLT among recipients did not differ by race (P >.05). Blacks were more likely to die or become too ill for OLT while waiting (P <.001). Blacks were less likely to receive OLT within 4 years (P <.001). In conclusion, adult blacks were underrepresented among OLT patients. Although waiting times were similar once listed, black race affected outcomes while awaiting OLT. The process of referral and evaluation for OLT should be investigated further.

Adult↗

Adherence to practice guidelines: the role of specialty society guidelines.

BACKGROUND: Physician adherence to guidelines is often poor, but the reasons have not been completely studied. We investigated whether physician adherence to guidelines for percutaneous transluminal coronary angioplasty (PTCA) and coronary artery bypass grafting (CABG) varied by source, development methods, or the extent of their evidence-base. METHODS AND RESULTS: We assessed adherence to guidelines developed by the American College of Cardiology/American Heart Association (ACC/AHA) for PTCA (1988 and 1993) and for CABG (1990) and guidelines developed by RAND for PTCA and CABG in 1990. We randomly sampled patients on Medicare who were undergoing coronary angiography in 5 states in 1991 and 1992, extracting clinical and laboratory data from medical records and using computer programs to classify the appropriateness of each procedure. A total of 543 PTCA and 676 CABG procedures were studied. By use of the 1988 ACC/AHA guidelines, 30% of PTCAs were rated class III (inappropriate), whereas 24% were class III by use of the 1993 guidelines. Only 1.5% of CABG procedures were class III with ACC/AHA guidelines. By use of RAND guidelines, 12% of PTCA and 9% of CABG procedures were classified as inappropriate. CONCLUSIONS: Adherence to guidelines is higher when the recommendations are supported by evidence from randomized clinical trials (CABG). The credibility of the source and familiarity with the guidelines do not ensure compliance. When evidence is lacking, as with PTCA at the time of this study, guideline recommendations may lag behind appropriate changes in clinical practice. More frequent revisions coupled with on-line access have the potential to make guidelines more useful.

Aged↗

Characteristics of medical school faculty members serving on institutional review boards: results of a national survey.

PURPOSE: To understand the characteristics of medical school faculty members who serve on institutional review boards (IRBs) in U.S. academic health centers. METHOD: Between October 2001 and March 2002, a questionnaire was mailed to a stratified random sample of 4,694 faculty members in 121 four-year medical schools in the United States (excluding Puerto Rico). The sample was drawn from the Association of American Medical College's faculty roster database for 1999. The primary independent variable was service on an IRB. Data were analyzed using standard statistical procedures. RESULTS: A total of 2,989 faculty members responded (66.5%). Eleven percent of respondents reported they had served on an IRB in the three years before the study. Of these, 73% were male, 81% were white (non-Hispanic). Virtually all faculty IRB members (94%) conducted some research in the three years before the study, and, among these, 71% reported conducting clinical research, and 47% served as industrial consultants to industry. Underrepresented minority faculty members were 3.2 times more likely than white faculty members to serve on the IRB. Clinical researchers were 1.64 times more likely to be on an IRB than were faculty members who conducted nonclinical research. No significant difference was found in the average number of articles published in the three years before the study comparing IRB faculty to non-IRB faculty. CONCLUSIONS: The faculty members who serve on IRBs tend to have research experience and knowledge that may be used to inform their IRB-related activities. However, the fact that almost half of all faculty IRB members serve as consultants to industry raises potential conflicts of interest.

Biomedical Research↗