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The paper discusses the impact of centre selection on the generalisability of randomised controlled trial (RCT)-based economic evaluations and suggests a future research agenda. The first section briefly reviews the current methods for addressing generalisability. We argue that these methods make no verifiable assumptions about how representative the recruiting centres are to the population of centres in the jurisdiction. The second section uses data from a multicentre RCT to illustrate that cost-effectiveness estimates can be influenced by the sample of recruiting centres. Finally, we propose two concepts that may advance generalisability research. First, we distinguish between the 'research space' and the 'policy space' and argue that policy makers are interested in the latter, while current methods describe the former. Second, we propose a centre-specific generalisability index used at RCT design stage to address generalisability. We conclude that future research should focus on generalisability at RCT design stage rather than on post hoc analyses., (Copyright © 2014 John Wiley & Sons, Ltd.)

Background: Reperfusion therapy for acute myocardial infarction (AMI) is a time-dependent intervention that can reduce infarct-related morbidity and mortality. Out-of-hospital patient delay from symptom onset until emergency department (ED) presentation may reduce the expected benefit of reperfusion therapy., Objective: To determine the impact of a community educational intervention to reduce patient delay time on the use of reperfusion therapy for AMI., Methods: This was a randomized, controlled community-based trial to enhance patient recognition of AMI symptoms and encourage early ED presentation with resultant increased reperfusion therapy rates for AMI. The study took place in 44 hospitals in 20 pair-matched communities in five U.S. geographic regions. Eligible study subjects were non-institutionalized patients without chest injury (aged > or =30 years) who were admitted to participating hospitals and who received a hospital discharge diagnosis of AMI (ICD 410); n = 4,885. For outcome assessment, patients were excluded if they were without survival data (n = 402), enrolled in thrombolytic trials (n = 61), receiving reperfusion therapy >12 hours after ED arrival (n = 628), or missing symptom onset or reperfusion times (n = 781). The applied intervention was an educational program targeting community organizations and the general public, high-risk patients, and health professionals in target communities. The primary outcome was a change in the proportion of AMI patients receiving early reperfusion therapy (i.e., within one hour of ED arrival or within six hours of symptom onset). Trends in reperfusion therapy rates were determined after adjustment for patient demographics, presenting blood pressure, cardiac history, and insurance status. Four-month baseline was compared with the 18-month intervention period., Results: Of 3,013 selected AMI patients, 40% received reperfusion therapy. Eighteen percent received therapy within one hour of ED arrival (46% of treated patients), and 32% within six hours of symptom onset (80% of treated patients). No significant difference in the trends in reperfusion therapy rates was attributable to the intervention, although increases in early reperfusion therapy rates were noted during the first six months of the intervention. A significant association of early reperfusion therapy use with ambulance use was identified., Conclusions: Community-wide educational efforts to enhance patient response to AMI symptoms may not translate into sustained changes in reperfusion practices. However, an increased odds for early reperfusion therapy use during the initiation of the intervention and the association of early therapy with ambulance use suggest that reperfusion therapy rates can be enhanced.

Objective: Early reperfusion for acute myocardial infarction (AMI) can reduce morbidity and mortality, yet there is often delay in accessing medical care after symptom onset. This report describes the design and baseline characteristics of the Rapid Early Action for Coronary Treatment (REACT) community trial, which is testing community intervention to reduce delay., Methods: Twenty U.S. communities were pair-matched and randomly assigned within pairs to intervention or comparison. Four months of baseline data collection was followed by an 18-month intervention of community organization and public, patient, and health professional education. Primary cases were community residents seen in the ED with chest pain, admitted with suspected acute cardiac ischemia, and discharged with a diagnosis related to coronary heart disease. The primary outcome was delay time from symptom onset to ED arrival. Secondary outcomes included delay time in patients with MI/unstable angina, hospital case-fatality rate and length of stay, receipt of reperfusion, and ED/emergency medical services utilization. Impact on public and patient knowledge, attitudes, and intentions was measured by telephone interviews. Characteristics of communities and cases and comparability of paired communities at baseline were assessed., Results: Baseline cases are 46% female, 14% minorities, and 73% aged > or =55 years, and paired communities have similar demographics characteristics. Median delay time (available for 72% of cases) is 2.3 hours and does not vary between treatment conditions (p > 0.86)., Conclusions: REACT communities approximate the demographic distribution of the United States and there is baseline comparability between the intervention and comparison groups. The REACT trial will provide valuable information for community educational programs to reduce patient delay for AMI symptoms.

During the school years, students encounter peer influences and role models who encourage smoking initiation. To counteract these influences, schools can provide comprehensive programs that include smoking prevention and cessation education and a supportive nonsmoking environment. In the past several years, programs and information have become available to help schools establish curricula to address smoking and to create nonsmoking environments. In addition, state and local governments have acted to legally restrict smoking in schools or to require smoking content in curricula. Efforts can be categorized into three avenues of intervention: student education, school and school system policy, and governmental regulation. Resources are suggested for each category to assist in developing a comprehensive intervention to foster nonsmoking by children and adolescents in the school setting.