Abstract

Traditional meta-analyses synthesise aggregate data obtained from study publications or study authors, such as a treatment effect estimate and its associated uncertainty. An increasingly popular approach is the meta-analysis of individual participant data (IPD) where the raw individual-level data are obtained for each study and used for synthesis. This study compares and discusses results from an IPD meta-analysis vs standard meta-analysis of randomized controlled trials of exercise cardiac rehabilitation in chronic heart failure (CHF). Based on a previous systematic review, the Exercise Training Meta-Analysis of Trials for Chronic Heart Failure (ExTraMATCH II) identified and collected IPD from RCTs that compared exercise rehabilitation with a non-exercise control and a minimum follow-up of 6 months. Outcomes of interest were mortality, hospitalization, exercise capacity and health-related quality of life. Original IPD were checked for consistency and compiled in a master dataset. Standard meta-analytic models were used for aggregate data whilst one-step approaches accounting for the clustering of participants within studies were planned for statistical analyses of IPD. Overall 33 RCTs were included in the original systematic review, whereas within the ExTraMatch II project, IPD were obtained from 19 RCTs in approximately 4,000 patients. From aggregate data there was no significant difference in pooled mortality (RR 0.92, 95%CI 0.67 to 1.26), whereas there was an effect of exercise rehabilitation on hospitalization (RR 0.75, 95% CI 0.62 to 0.92) and health related quality of life (SMD −0.46, 95% CI −0.66 to −0.26). IPD analysis is currently underway; the results will allow examining how patients’ characteristics modify treatment benefit. Given the limitations of current evidence in CHF, access to individual data from several RCTs offers a timely and important opportunity to revisit the question of which CHF patient subgroups benefit most from exercise-based rehabilitation.

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