Objective. To describe, qualitatively and quantitatively, the impact of a review by multiple institutional review boards (IRBs) (1) Recruitment, retention, and communication issues with local site principal investigators (PIs). Local PIs had no real role but were required by IRBs. Twenty-one percent of sites experienced turnover in local PIs, and local PI issues added significant delay to most sites.(2) Wide variation in standards applied to review and approval of IRB applications. The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA (Health Insurance Portability and Accountability Act of 1996) consent from physicians although no health information was asked of them. Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants.(3) Multiple returns for revision of IRB applications, consent documents, and ancillary forms. Seventy-six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions. Only 12 percent of sites required any procedural or substantive revision; most resubmissions were editorial changes to the wording of the consent document.

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BackgroundReviews of guideline implementation recommend matching strategies to the specific setting, but provide little specific guidance about how to do so. We hypothesized that the highest level of guideline-concordant care would be achieved where implementation strategies fit well with physicians' cognitive styles.MethodsWe conducted an observational study of the implementation of guidelines for hypertension management among patients with diabetes at 43 Veterans' Health Administration medical center primary care clinics. Clinic leaders provided information about all implementation strategies employed at their sites. Guidelines implementation strategies were classified as education, motivation/incentive, or barrier reduction using a pre-specified system. Physician's cognitive styles were measured on three scales: evidence vs. experience as the basis of knowledge, sensitivity to pragmatic concerns, and conformity to local practices. Doctors' decisions were designated guideline-concordant if the patient's blood pressure was within goal range, or if the blood pressure was out of range and a dose change or medication change was initiated, or if the patient was already using medications from three classes.ResultsThe final sample included 163 physicians and 1,174 patients. All of the participating sites used one or more educational approaches to implement the guidelines. Over 90% of the sites also provided group or individual feedback on physician performance on the guidelines, and over 75% implemented some type of reminder system. A minority of sites used monetary incentives, penalties, or barrier reduction. The only type of intervention that was associated with increased guideline-concordant care in a logistic model was barrier reduction (p < 0.02). The interaction between physicians' conformity scale scores and the effect of barrier reduction was significant (p < 0.05); physicians ranking lower on the conformity scale responded more to barrier reduction.ConclusionGuidelines implementation strategies that were designed to reduce physician time pressure and task complexity were the only ones that improved performance. Education may have been necessary but was clearly not sufficient, and more was not better. Incentives had no discernible effect. Measurable physician characteristics strongly affected response to implementation strategies.

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