Objective Evaluate the quality of exercise randomised controlled trial (RCT) reporting and conduct in clinical populations (ie, adults with or at risk of chronic conditions) and compare with matched pharmacological RCTs.
Design Systematic review.
Data sources Embase (Elsevier), PubMed (NLM) and CINAHL (EBSCO).
Study selection RCTs of exercise in clinical populations with matching pharmacological RCTs published in leading clinical, medical and specialist journals with impact factors ≥15.
Review methods Overall RCT quality was evaluated by two independent reviewers using three research reporting guidelines (ie, Consolidated Standards of Reporting Trials (CONSORT; pharmacological RCTs)/CONSORT for non-pharmacological treatments; exercise RCTs), CONSORT-Harms, Template for Intervention Description and Replication) and two risk of bias assessment (research conduct) tools (ie, Cochrane Risk of Bias, Jadad Scale). We compared research reporting and conduct quality within exercise RCTs with matched pharmacological RCTs, and examined factors associated with quality in exercise and pharmacological RCTs, separately.
Findings Forty-eight exercise RCTs (11 658 patients; median sample n=138) and 48 matched pharmacological RCTs were evaluated (18 501 patients; median sample n=160). RCTs were conducted primarily in cardiovascular medicine (43%) or oncology (31%). Overall quality score (composite of all research reporting and conduct quality scores; primary endpoint) for exercise RCTs was 58% (median score 46 of 80; IQR: 39–51) compared with 77% (53 of 68; IQR: 47–58) in the matched pharmacological RCTs (p≤0.001). Individual quality scores for trial reporting and conduct were lower in exercise RCTs compared with matched pharmacological RCTs (p≤0.03). Factors associated with higher overall quality scores for exercise RCTs were journal impact factor (≥25), sample size (≥152) and publication year (≥2013).
Conclusions and relevance Research reporting and conduct quality within exercise RCTs is inferior to matched pharmacological RCTs. Suboptimal RCT reporting and conduct impact the fidelity, interpretation, and reproducibility of exercise trials and, ultimately, implementation of exercise in clinical populations.
PROSPERO registration number CRD42018095033.
- clinical trials
- rehabilitation medicine
- clinical pharmacology
- statistics & research methods
Data availability statement
All data relevant to the study are included in the article or uploaded as supplemental information.
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JMS and LWJ contributed equally.
Contributors LWJ conceived the study idea. SCA and JMS coordinated the systematic review. SCA, LWJ and JMS wrote the first draft of the manuscript. KM designed the search strategy. KS and JM screened abstracts and full texts. JM, KS, MMZC and SCA acquired the data. JM, KS and SCA judged risk of bias in the studies. JL and CSM performed the data analyses. SCA, JM, KS, KM, JL, CSM, MMZC, DSM, JMS and LWJ interpreted the data analysis. SCA, JM, KS, KM, JL, CSM, MMZC, DSM, JMS and LWJ critically revised the manuscript. LWJ had full access to all study data and takes responsibility for the integrity of the data and the accuracy of the data analysis. The findings of this study have been presented clearly, honestly, and without fabrication, falsification, or inappropriate data manipulation. LWJ is the guarantor.
Funding LWJ and JMS are supported by research grants from the National Cancer Institute. LWJ and JMS are supported by AKTIV Against Cancer. JL, CSM, JMS and LWJ are supported by the Memorial Sloan Kettering Cancer Center Support Grant/Core Grant (P30 CA008748).
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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