Anderson J Michael, Stafford Aaron, Jellison Samuel, Vassar Matt
Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, U.S.A.
Kansas City University of Medicine and Biosciences, Joplin, Missouri, U.S.A.
Arthrosc Sports Med Rehabil. 2021 Apr 24;3(3):e619-e627. doi: 10.1016/j.asmr.2020.09.019. eCollection 2021 Jun.
Outcomes of randomized controlled trials (RCTs) have been shown to influence clinical decision making. Thus, the quality and reliability of these outcomes are essential for both patients and medical care providers. To date, no study has assessed the quality of intervention reporting of RCTs in orthopaedics. The aim of this study was to evaluate the quality of intervention reporting of published RCTs in the field of orthopaedics using the Template for Intervention Description and Replication (TIDieR) checklist.
In this cross-sectional analysis, we applied the TIDieR checklist to assess the quality of intervention reporting in orthopaedic RCTs. Additionally, we evaluated the TIDieR checklist's influence on intervention reporting by comparing overall adherence to checklist items in trials published before the TIDieR checklist's release versus trials published after its release. Finally, we assessed whether certain factors were associated with the quality of intervention reporting.
From a random sample of 300 publications in orthopaedic journals, 175 parallel-arm and cluster RCTs were identified. The overall rate of adherence to TIDieR items was 58.4%. Only 31.4% of orthopaedic RCTs adhered to at least 6 of the 12 TIDieR checklist items, whereas 0% adhered to all 12 items. We found no significant improvement in the quality of intervention reporting in studies published after the TIDieR checklist's release compared with studies published before its release ( = .97). Additionally, preregistered trials were associated with more complete intervention reporting.
Our results suggest suboptimal reporting of orthopaedic RCT interventions. In addition, the TIDieR checklist's intended effect-to better the quality of RCT intervention reporting-appears to have fallen short of its goal.
Because outcomes of RCTs are used to guide clinical decision making, it is essential that orthopaedic surgeons and clinical practice guideline panels are equipped with high-quality published research. Increasing the accuracy of intervention reporting may lead to more accurate clinical application. Thus, adoption of more stringent reporting of trial interventions by researchers, authors, and journal editors may improve the quality of orthopaedic research, as well as improve patient outcomes.
随机对照试验(RCT)的结果已被证明会影响临床决策。因此,这些结果的质量和可靠性对患者和医疗服务提供者都至关重要。迄今为止,尚无研究评估骨科RCT中干预措施报告的质量。本研究的目的是使用干预描述与复制模板(TIDieR)清单评估骨科领域已发表RCT中干预措施报告的质量。
在这项横断面分析中,我们应用TIDieR清单来评估骨科RCT中干预措施报告的质量。此外,我们通过比较TIDieR清单发布前发表的试验与发布后发表的试验对清单项目的总体依从性,评估了TIDieR清单对干预措施报告的影响。最后,我们评估了某些因素是否与干预措施报告的质量相关。
从骨科期刊的300篇出版物随机样本中,识别出175项平行组和整群RCT。对TIDieR项目的总体依从率为58.4%。只有31.4%的骨科RCT遵守了12项TIDieR清单项目中的至少6项,而0%遵守了所有12项。我们发现,与TIDieR清单发布前发表的研究相比,清单发布后发表的研究在干预措施报告质量方面没有显著改善(P = 0.97)。此外,预先注册的试验与更完整的干预措施报告相关。
我们的结果表明骨科RCT干预措施的报告不理想。此外,TIDieR清单想要提高RCT干预措施报告质量的预期效果似乎未达到目标。
由于RCT的结果用于指导临床决策,骨科外科医生和临床实践指南小组必须掌握高质量的已发表研究。提高干预措施报告的准确性可能会带来更准确的临床应用。因此,研究人员、作者和期刊编辑采用更严格的试验干预措施报告方式,可能会提高骨科研究的质量,并改善患者的治疗效果。