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Background: The pragmatic-explanatory continuum indicator summary version 2 (PRECIS-2) tool has recently been developed to classify randomized clinical trials (RCTs) as pragmatic or explanatory based on their design characteristics. Given that treatment effects in explanatory trials may be greater than those obtained in pragmatic trials, conventional meta-analytic approaches may not accurately account for the heterogeneity among the studies and may result in biased treatment effect estimates. This study investigates if the incorporation of PRECIS-2 classification of published trials can improve the estimation of overall intervention effects in meta-analysis. Methods: Using data from 31 published trials of intervention aimed at reducing obesity in children, we evaluated the utility of incorporating PRECIS-2 ratings of published trials into meta-analysis of intervention effects in clinical trials. Specifically, we compared random-effects meta-analysis, stratified meta-analysis, random-effects meta-regression, and mixture random-effects meta-regression methods for estimating overall pooled intervention effects. Results: Our analyses revealed that mixture meta-regression models that incorporate PRECIS-2 classification as covariate resulted in a larger pooled effect size (ES) estimate (ES = - 1.01, 95%CI = [- 1.52, - 0.43]) than conventional random-effects meta-analysis (ES = - 0.15, 95%CI = [- 0.23, - 0.08]). Conclusions: In addition to the original intent of PRECIS-2 tool of aiding researchers in their choice of trial design, PRECIS-2 tool is useful for explaining between study variations in systematic review and meta-analysis of published trials. We recommend that researchers adopt mixture meta-regression methods when synthesizing evidence from explanatory and pragmatic trials. [ABSTRACT FROM AUTHOR]

Background: The Seattle Angina Questionnaire (SAQ) is a widely-used patient-reported outcomes measure in patients with heart disease. This study assesses the validity and reliability of the SAQ in a Canadian cohort of individuals with stable angina.Methods and Results: Data are from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH) registry, a population-based registry of patients who received cardiac catheterization in Alberta, Canada. The cohort consists of 4052 patients undergoing cardiac catheterization for stable angina and completed the SAQ within 2 weeks. Exploratory factor analysis and confirmatory factor analysis (CFA) were used to assess the factorial structure of the SAQ. Internal and test-retest reliabilities of a new measure (i.e., SAQ-CAN) was measured using Cronbach α and intraclass correlation coefficient, respectively. CFA model fit was assessed using the root mean square error of approximation (RMSEA) and comparative fit index (CFI). Construct validity of the SAQ-CAN was assessed in relation to Hospital Anxiety and Depression Scales (HADS), Euro Quality of life 5 dimension (EQ5D), and original SAQ. Of the 4052 patients included in this analysis, 3281 (80.97%) were younger than 75 years old, while 3239 (79.94%) were male. Both exploratory and confirmatory factor analyses revealed a four-factorial structure consisting of 16 items that provided a better fit to the data (RMSEA = 0.049 [90% CI = (0.047, 0.052)]; CFI = 0.975). The 16-item SAQ demonstrated good to excellent internal reliability (Cronbach's α range from 0.77 to 0.90), moderate to strong correlation with the Original SAQ and EQ5D but negligible correlations with HADS.Conclusion: The SAQ-CAN has acceptable psychometric properties that are comparable to the original SAQ. We recommend its use for assessing coronary health outcomes in Canadian patients with Coronary Artery Disease. [ABSTRACT FROM AUTHOR]