Comparing the reporting and conduct quality of exercise and pharmacological randomised controlled trials: a systematic review

被引:11
|
作者
Adams, Scott C. [1 ,2 ,3 ]
McMillan, Julia [4 ]
Salline, Kirsten [5 ]
Lavery, Jessica [6 ]
Moskowitz, Chaya S. [6 ]
Matsoukas, Konstantina [7 ]
Chen, Maggie M. Z. [3 ]
Santa Mina, Daniel [3 ,8 ]
Scott, Jessica M. [9 ,10 ]
Jones, Lee W. [9 ,10 ]
机构
[1] Toronto Gen Res Inst, Dept Cardiol, Toronto, ON, Canada
[2] Peter Munk Cardiac Ctr, Ted Rogers Cardiotox Prevent Program, Toronto, ON, Canada
[3] Univ Toronto, Kineslol & Phys Educ, Toronto, ON, Canada
[4] Albert Einstein Coll Med, Bronx, NY 10467 USA
[5] NYU Langone Hlth, Internal Med, New York, NY USA
[6] Mem Sloan Kettering Canc Ctr, Epidemiol & Biostat, 1275 York Ave, New York, NY 10021 USA
[7] Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA
[8] Toronto Gen Hosp, Anesthesia & Pain Management, Toronto, ON, Canada
[9] Mem Sloan Kettering Canc Ctr, Med, 1275 York Ave, New York, NY 10021 USA
[10] Weill Cornell Med Coll, Med, New York, NY 10065 USA
来源
BMJ OPEN | 2021年 / 11卷 / 08期
关键词
clinical trials; rehabilitation medicine; clinical pharmacology; statistics & research methods; PERIPHERAL ARTERY-DISEASE; CHRONIC HEART-FAILURE; PRESERVED EJECTION FRACTION; OBSTRUCTIVE PULMONARY-DISEASE; ANDROGEN-DEPRIVATION THERAPY; COLONY-STIMULATING FACTOR; METASTATIC BREAST-CANCER; PEAK OXYGEN-CONSUMPTION; FATTY LIVER-DISEASE; DOUBLE-BLIND;
D O I
10.1136/bmjopen-2020-048218
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
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页数:17
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