Tew Garry A, Brabyn Sally, Cook Liz, Peckham Emily
Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle Upon Tyne, United Kingdom.
Mental Health and Addiction Group, Department of Health Sciences, University of York, York, United Kingdom.
PLoS One. 2016 Mar 3;11(3):e0150869. doi: 10.1371/journal.pone.0150869. eCollection 2016.
Research supports the use of supervised exercise training as a primary therapy for improving the functional status of people with peripheral arterial disease (PAD). Several reviews have focused on reporting the outcomes of exercise interventions, but none have critically examined the quality of intervention reporting. Adequate reporting of the exercise protocols used in randomised controlled trials (RCTs) is central to interpreting study findings and translating effective interventions into practice. The purpose of this review was to evaluate the completeness of intervention descriptions in RCTs of supervised exercise training in people with PAD. A systematic search strategy was used to identify relevant trials published until June 2015. Intervention description completeness in the main trial publication was assessed using the Template for Intervention Description and Replication checklist. Missing intervention details were then sought from additional published material and by emailing authors. Fifty-eight trials were included, reporting on 76 interventions. Within publications, none of the interventions were sufficiently described for all of the items required for replication; this increased to 24 (32%) after contacting authors. Although programme duration, and session frequency and duration were well-reported in publications, complete descriptions of the equipment used, intervention provider, and number of participants per session were missing for three quarters or more of interventions (missing for 75%, 93% and 80% of interventions, respectively). Furthermore, 20%, 24% and 26% of interventions were not sufficiently described for the mode of exercise, intensity of exercise, and tailoring/progression, respectively. Information on intervention adherence/fidelity was also frequently missing: attendance rates were adequately described for 29 (38%) interventions, whereas sufficient detail about the intensity of exercise performed was presented for only 8 (11%) interventions. Important intervention details are commonly missing for supervised exercise programmes in the PAD trial literature. This has implications for the interpretation of outcome data, the investigation of dose-response effects, and the replication of protocols in future studies and clinical practice. Researchers should be mindful of intervention reporting guidelines when attempting to publish information about supervised exercise programmes, regardless of the population being studied.
研究支持将有监督的运动训练作为改善外周动脉疾病(PAD)患者功能状态的主要疗法。已有多项综述着重报告运动干预的结果,但尚无一项对干预措施报告的质量进行严格审查。随机对照试验(RCT)中所使用运动方案的充分报告对于解读研究结果以及将有效干预措施应用于实践至关重要。本综述的目的是评估PAD患者有监督运动训练的RCT中干预措施描述的完整性。采用系统检索策略来识别截至2015年6月发表的相关试验。使用干预描述与复制模板清单评估主要试验出版物中干预措施描述的完整性。随后从其他已发表材料以及通过给作者发邮件来查找缺失的干预细节。纳入了58项试验,报告了76种干预措施。在出版物中,没有一项干预措施针对复制所需的所有项目进行了充分描述;在与作者联系后,这一比例增至24项(32%)。尽管出版物中对项目持续时间、 sessions频率和时长报告良好,但四分之三或更多的干预措施缺少对所使用设备、干预提供者以及每次session参与者数量的完整描述(分别有75%、93%和80%的干预措施缺失)。此外,分别有20%、24%和26%的干预措施在运动方式、运动强度以及调整/进展方面描述不充分。关于干预依从性/保真度的信息也经常缺失:29项(38%)干预措施充分描述了出勤率,而只有8项(11%)干预措施提供了所进行运动强度的足够细节。在PAD试验文献中,有监督运动方案通常缺少重要的干预细节。这对结果数据的解读、剂量反应效应的研究以及未来研究和临床实践中方案的复制均有影响。研究人员在试图发表有关有监督运动方案的信息时,无论所研究的人群如何,都应留意干预措施报告指南。