Department of Cardiology, Toronto General Research Institute, Toronto, Ontario, Canada.
Ted Rogers Cardiotoxicity Prevention Program, Peter Munk Cardiac Centre, Toronto, Ontario, Canada.
BMJ Open. 2021 Aug 11;11(8):e048218. doi: 10.1136/bmjopen-2020-048218.
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.
Systematic review.
Embase (Elsevier), PubMed (NLM) and CINAHL (EBSCO).
RCTs of exercise in clinical populations with matching pharmacological RCTs published in leading clinical, medical and specialist journals with impact factors ≥15.
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.
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).
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.
CRD42018095033.
评估针对临床人群（即患有或有患慢性病风险的成年人）开展的运动随机对照试验（RCT）的报告和实施质量，并与匹配的药物 RCT 进行比较。
系统评价。
Embase（爱思唯尔）、PubMed（NLM）和 CINAHL（EBSCO）。
在具有影响力因子≥15 的主要临床、医学和专科期刊上发表的针对临床人群的运动 RCT，与匹配的药物 RCT 进行匹配。
两名独立评审员使用三项研究报告指南（即 CONSORT；药物 RCT/非药物治疗 CONSORT；运动 RCT）、CONSORT-Harms、干预描述和复制模板）和两项偏倚风险评估（研究实施）工具（即 Cochrane 偏倚风险、Jadad 量表）评估总体 RCT 质量。我们比较了运动 RCT 与匹配的药物 RCT 内部的研究报告和实施质量，并分别检查了运动和药物 RCT 质量相关的因素。
共评估了 48 项运动 RCT（11658 例患者；中位数样本量 n=138）和 48 项匹配的药物 RCT（18501 例患者；中位数样本量 n=160）。RCT 主要在心血管医学（43%）或肿瘤学（31%）中开展。运动 RCT 的总体质量评分（所有研究报告和实施质量评分的综合评分；主要终点）为 58%（中位数评分为 80 分中的 46 分；IQR：39-51），而匹配的药物 RCT 为 77%（53 分中的 47-58）（p≤0.001）。与匹配的药物 RCT 相比，运动 RCT 的试验报告和实施的个别质量评分较低（p≤0.03）。与运动 RCT 整体质量评分较高相关的因素包括期刊影响力因子（≥25）、样本量（≥152）和发表年份（≥2013）。
运动 RCT 中的研究报告和实施质量不如匹配的药物 RCT。次优的 RCT 报告和实施影响了运动试验的保真度、解释和可重复性，最终影响了运动在临床人群中的实施。
PROSPERO 注册号：CRD42018095033。
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