Human subjects protection issues in QUERI implementation research: QUERI Series

<p>Abstract</p> <p>Background</p> <p>Human Subjects protections approaches, specifically those relating to research review board oversight, vary throughout the world. While all are designed to protect participants involved in research, the structure and specifics of these institutional review boards (IRBs) can and do differ. This variation affects all types of research, particularly implementation research.</p> <p>Methods</p> <p>In 2001, we began a series of inter-related studies on implementing evidence-based collaborative care for depression in Veterans Health Administration primary care. We have submitted more than 100 IRB applications, amendments, and renewals, and in doing so, we have interacted with 13 VA and University IRBs across the United States (U.S.). We present four overarching IRB-related themes encountered throughout the implementation of our projects, and within each theme, identify key challenges and suggest approaches that have proved useful. Where applicable, we showcase process aids developed to assist in resolving a particular IRB challenge.</p> <p>Results</p> <p>There are issues unique to implementation research, as this type of research may not fit within the traditional Human Subjects paradigm used to assess clinical trials. Risks in implementation research are generally related to breaches of confidentiality, rather than health risks associated with traditional clinical trials. The implementation-specific challenges discussed are: external validity considerations, Plan-Do-Study-Act cycles, risk-benefit issues, the multiple roles of researchers and subjects, and system-level unit of analysis.</p> <p>Discussion</p> <p>Specific aspects of implementation research interact with variations in knowledge, procedures, and regulatory interpretations across IRBs to affect the implementation and study of best methods to increase evidence-based practice. Through lack of unambiguous guidelines and local liability concerns, IRBs are often at risk of applying both variable and inappropriate or unnecessary standards to implementation research that are not consistent with the spirit of the Belmont Report (a summary of basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research), and which impede the conduct of evidence-based quality improvement research. While there are promising developments in the IRB community, it is incumbent upon implementation researchers to interact with IRBs in a manner that assists appropriate risk-benefit determinations and helps prevent the process from having a negative impact on efforts to reduce the lag in implementing best practices.</p

Alcohol Consumption Among Older Adults in Primary Care

BACKGROUND: Alcohol misuse is a growing public health concern for older adults, particularly among primary care patients. OBJECTIVES: To determine alcohol consumption patterns and the characteristics associated with at-risk drinking in a large sample of elderly primary care patients. DESIGN: Cross-sectional analysis of multisite screening data from 6 VA Medical Centers, 2 hospital-based health care networks, and 3 Community Health Centers. PARTICIPANTS: Patients, 43,606, aged 65 to 103 years, with scheduled primary care appointments were approached for screening; 27,714 (63.6%) consented to be screened. The final sample of persons with completed screens comprised 24,863 patients. MEASUREMENTS: Quantity and frequency of alcohol use, demographics, social support measures, and measures of depression/anxiety. RESULTS: Of the 24,863 older adults screened, 70.0% reported no consumption of alcohol in the past year, 21.5% were moderate drinkers (1–7 drinks/week), 4.1% were at-risk drinkers (8–14 drinks/week), and 4.5% were heavy (>14 drinks/week) or binge drinkers. Heavy drinking showed significant positive association with depressive/anxiety symptoms [Odds ratio (OR) (95% CI): 1.79 (1.30, 2.45)] and less social support [OR (95% CI): 2.01 (1.14, 2.56)]. Heavy drinking combined with binging was similarly positively associated with depressive/anxiety symptoms [OR (95%): 1.70 (1.33, 2.17)] and perceived poor health [OR (95% CI): 1.27 (1.03, 1.57)], while at-risk drinking was not associated with any of these variables. CONCLUSIONS: The majority of participants were nondrinkers; among alcohol users, at-risk drinkers did not differ significantly from moderate drinkers in their characteristics or for the 3 health parameters evaluated. In contrast, heavy drinking was associated with depression and anxiety and less social support, and heavy drinking combined with binge drinking was associated with depressive/anxiety symptoms and perceived poor health

Women’s Early Warning Symptoms of Acute Myocardial Infarction

Background— Data remain sparse on women’s prodromal symptoms before acute myocardial infarction (AMI). This study describes prodromal and AMI symptoms in women.Methods and Results— Participants were 515 women diagnosed with AMI from 5 sites. Using the McSweeney Acute and Prodromal Myocardial Infarction Symptom Survey, we surveyed them 4 to 6 months after discharge, asking about symptoms, comorbidities, and demographic characteristics. Women were predominantly white (93%), high school educated (54.8%), and older (mean age, 66±12), with 95% (n=489) reporting prodromal symptoms. The most frequent prodromal symptoms experienced more than 1 month before AMI were unusual fatigue (70.7%), sleep disturbance (47.8%), and shortness of breath (42.1%). Only 29.7% reported chest discomfort, a hallmark symptom in men. The most frequent acute symptoms were shortness of breath (57.9%), weakness (54.8%), and fatigue (42.9%). Acute chest pain was absent in 43%. Women had more acute (mean, 7.3±4.8; range, 0 to 29) than prodromal (mean, 5.71±4.36; range, 0 to 25) symptoms. The average prodromal score, symptom weighted by frequency and intensity, was 58.5±52.7, whereas the average acute score, symptom weighted by intensity, was 16.5±12.1. These 2 scores were correlated (r=0.61, P\u3c0.001). Women with more prodromal symptoms experienced more acute symptoms. After controlling for risk factors, prodromal scores accounted for 33.2% of acute symptomatology.Conclusions— Most women have prodromal symptoms before AMI. It remains unknown whether prodromal symptoms are predictive of future events

Effects of sustained audit/feedback on self-reported health status of primary care patients

PURPOSE: Because limited audit/feedback of health status information has yielded mixed results, we evaluated the effects of a sustained program of audit/feedback on patient health and satisfaction. METHODS: We conducted a group-randomized effectiveness trial in which firms within Veterans Administration general internal medicine clinics served as units of randomization, intervention, and analysis. Respondents to a baseline health inventory were regularly mailed the 36-Item Short Form (SF-36) and, as relevant, questionnaires about six chronic conditions (ischemic heart disease, diabetes, chronic obstructive pulmonary disease, depression, alcohol use, and hypertension) and satisfaction with care. Data were reported to primary providers at individual patient visits and in aggregate during a 2-year period. RESULTS: Baseline forms were mailed to 34,050 patients; of the 22,413 respondents, 15,346 completed and returned follow-up surveys. Over the 2-year study, the difference between intervention and control groups (as measured by difference in average slope) was -0.26 (95% confidence interval [CI]: -0.79 to 0.27; P=0.28) for the SF-36 Physical Component Summary score and -0.53 (95% CI: -1.09 to 0.03; P=0.06) for the SF-36 Mental Component Summary score. No significant differences emerged after adjusting for deaths. There were no significant differences in condition-specific measures or satisfaction between groups after adjustment for provider type, panel size, and number of intervention visits, or after analysis of patients who completed all forms. CONCLUSION: An elaborate, sustained audit/feedback program of general and condition-specific measures of health/satisfaction did not improve outcomes. To be effective, such data probably should be incorporated into a comprehensive chronic disease management program