What determines whether patients are willing to participate in resuscitation studies requiring exception from informed consent?

OBJECTIVES: To examine the willingness of patients to participate in a resuscitation study that requires exception from informed consent and to determine if willingness to participate is associated with demographic and other characteristics. METHODS: Adult patients in an emergency department and in a geriatric outpatient clinic were surveyed. Patients were asked to imagine that they presented to an emergency department with cardiac arrest and asked about their willingness to (1) receive a new drug outside of a study, (2) receive a new drug as part of a study and (3) participate in a randomised controlled trial (RCT) for a new drug. Patients were also asked about participation in studies of invasive procedures. RESULTS: 213 patients from a geriatric clinic and 207 from an emergency department were surveyed. Two thirds of patients from the geriatric clinic and 83% from the emergency department were willing to receive an experimental drug outside of a study. Patients were less willing to participate in a study of the new drug and even less likely to participate in an RCT for the new drug (chi(2) test for trend, p<0.001 for both settings). Patients were less likely to participate in a study of thoracotomy than in a study that required placement of a femoral catheter (p = 0.008 for the geriatric clinic, p = 0.01 for the emergency department). Willingness to participate was not associated with trust in the doctors. CONCLUSIONS: Study design and invasiveness of the intervention were associated with the willingness of patients to participate in resuscitation studies that require exception from informed consent.

Why don't physicians follow clinical practice guidelines? A framework for improvement.

CONTEXT: Despite wide promulgation, clinical practice guidelines have had limited effect on changing physician behavior. Little is known about the process and factors involved in changing physician practices in response to guidelines. OBJECTIVE: To review barriers to physician adherence to clinical practice guidelines. DATA SOURCES: We searched the MEDLINE, Educational Resources Information Center (ERIC), and HealthSTAR databases (January 1966 to January 1998); bibliographies; textbooks on health behavior or public health; and references supplied by experts to find English-language article titles that describe barriers to guideline adherence. STUDY SELECTION: Of 5658 articles initially identified, we selected 76 published studies describing at least 1 barrier to adherence to clinical practice guidelines, practice parameters, clinical policies, or national consensus statements. One investigator screened titles to identify candidate articles, then 2 investigators independently reviewed the texts to exclude articles that did not match the criteria. Differences were resolved by consensus with a third investigator. DATA EXTRACTION: Two investigators organized barriers to adherence into a framework according to their effect on physician knowledge, attitudes, or behavior. This organization was validated by 3 additional investigators. DATA SYNTHESIS: The 76 articles included 120 different surveys investigating 293 potential barriers to physician guideline adherence, including awareness (n = 46), familiarity(n = 31), agreement (n = 33), self-efficacy (n = 19), outcome expectancy (n = 8), ability to overcome the inertia of previous practice (n = 14), and absence of external barriers to perform recommendations (n = 34). The majority of surveys (70 [58%] of 120) examined only 1 type of barrier. CONCLUSIONS: Studies on improving physician guideline adherence may not be generalizable, since barriers in one setting may not be present in another. Our review offers a differential diagnosis for why physicians do not follow practice guidelines, as well as a rational approach toward improving guideline adherence and a framework for future research.

Predictors of common bile duct stones prior to cholecystectomy: a meta-analysis.

BACKGROUND: The decision of whether or not to investigate for common bile duct stones before cholecystectomy utilizes clinical, laboratory, and radiologic information (indicators). There is tremendous individual variation among clinicians in the criteria used for making this decision. Our aim was to perform a meta-analysis of published data to estimate the performance characteristics of the most commonly used preoperative indicators of common bile duct stones. METHODS: Using predetermined exclusion criteria, we selected articles from a MEDLINE search and bibliographic review. Weighted averages were used to determine summary sensitivity, specificity, and positive and negative likelihood ratios for each indicator for stones. RESULTS: From 2221 citations identified, 22 studies met inclusion criteria. The 10 indicators examined were reported in a common fashion in three or more articles, and could be assessed preoperatively. Seven exhibited a specificity greater than 90%. Indicators with positive likelihood ratios of 10 or above were cholangitis, preoperative jaundice, and ultrasound evidence of common bile duct stones. Positive likelihood ratios for dilated common bile duct on ultrasound, hyperbilirubinemia, and jaundice ranged from almost 4 to almost 7. Elevated levels of alkaline phosphatase, pancreatitis, cholecystitis, and hyperamylasemia exhibited positive likelihood ratios of less than 3. CONCLUSIONS: This meta-analysis has identified indicators for duct stones and ranked them according to likelihood ratios. These findings can be applied as guidelines for whether to investigate for duct stones before cholecystectomy.