Sakzewski Leanne, Reedman Sarah, Hoffmann Tammy
Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine and Biomedical Sciences, The University of Queensland, Brisbane, Australia.
Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine and Biomedical Sciences, The University of Queensland, Brisbane, Australia.
Res Dev Disabil. 2016 Dec;59:417-427. doi: 10.1016/j.ridd.2016.09.018. Epub 2016 Oct 11.
Incomplete reporting of components of interventions limits uptake of evidence into clinical practice.
To evaluate the completeness of reporting of research and control interventions in randomised trials of upper limb therapies for children with unilateral cerebral palsy.
Sixty randomized trials were included, encompassing 60 research and 68 control interventions. Using the 12-item Template for Intervention Description and Replication (TIDieR) checklist, two reviewers independently rated intervention and control descriptions.
When using 50% of studies as the benchmark, five of the 12 TIDieR items for the research intervention, eight of the 12 items for the control intervention and 11 of 12 items for "usual care" interventions were inadequately reported. Procedures used to deliver the research intervention were adequately reported for 63% of studies. Materials were used in 94% of research interventions, yet only 27% provided details to access/replicate materials. Training materials for interventionists were used in 38% of trials, 10 (17%) had procedure manuals, yet only 3 reported details to access materials. The location where the research intervention was provided was detailed in 65% of studies. Reporting of all items was poorer for the control intervention.
No study adequately reported all elements on the TIDieR checklist. Details crucial for replication of interventions and interpretation of results were missing. Authors, reviewers, and editors all have a responsibility to improve the quality of intervention reporting in published trials. The TIDieR guide is a potential solution, helping to structure accounts of interventions.
干预措施组成部分的报告不完整限制了证据在临床实践中的应用。
评估单侧脑瘫儿童上肢治疗随机试验中研究性干预和对照性干预的报告完整性。
纳入60项随机试验,涵盖60种研究性干预和68种对照性干预。使用12项干预描述与复制模板(TIDieR)清单,两名评审员独立对干预和对照描述进行评分。
以50%的研究作为基准时,研究性干预的12项TIDieR项目中有5项、对照性干预的12项中有8项以及“常规护理”干预的12项中有11项报告不充分。63%的研究充分报告了实施研究性干预所使用的程序。94%的研究性干预使用了材料,但只有27%提供了获取/复制材料的详细信息。38%的试验使用了干预人员的培训材料,10项(17%)有程序手册,但只有3项报告了获取材料的详细信息。65%的研究详细说明了提供研究性干预的地点。对照性干预所有项目的报告情况更差。
没有研究充分报告TIDieR清单上的所有要素。缺少对干预措施复制和结果解释至关重要的细节。作者、评审员和编辑都有责任提高已发表试验中干预措施报告的质量。TIDieR指南是一个潜在的解决方案,有助于构建干预措施的描述。