Sports Health. 2023 Jan-Feb;15(1):11-25. doi: 10.1177/19417381221112674. Epub 2022 Aug 1.
Clinical practice guidelines (CPGs) are vital to establishing a standardized and evidence-based approach in medicine. These guidelines rely on the use of methodologically sound clinical trials, and the subsequent reporting of their methodology.
To evaluate the completeness of randomized controlled trials (RCTs) underpinning CPGs published by the American Academy of Orthopedic Surgeons (AAOS) for management of osteoarthritis of the knee.
We searched the most recent AAOS CPGs for surgical and nonsurgical management of osteoarthritis of the knee for RCTs. To estimate the necessary sample size, we performed a power analysis using OpenEpi 3.0 (openepi.com).
Two authors independently screened the reference sections of the included CPGs. Included studies met the definition of an RCT, were retrievable in the English language, and were cited in at least one of the included CPGs.
Meta-Analysis.
Level 1a.
We performed double-blind screening and extraction of RCTs included in the AAOS CPGs. We evaluated each RCT for adherence to the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist. A multiple regression analysis was conducted to assess CONSORT adherence against characteristics of included studies (ie, type of intervention, funding source, etc).
Our study included 179 RCTs. The overall adherence was 68.5% with significant differences between those published before and since the development of the 2010 CONSORT guidelines ( = 0.02). We found that RCTs receiving funding from industry/private sources as well as studies that included a conflict of interest statement showed more completeness than RCTs that reported receiving no funding ( < 0.01).
We found suboptimal CONSORT adherence for RCTs cited in AAOS CGPs for management of osteoarthritis of the knee. Therefore, the CPGs are likely supported by outdated evidence and lack of high-quality reporting. It is important that evidence used to guide clinical decision making be of the highest quality in order to optimize patient outcomes. In order for clinicians to confer the greatest benefits to their patients, CPGs should provide the totality of evidence and emphasize emerging high-quality RCTs to ensure up-to-date, evidence-based clinical decision-making.
临床实践指南（CPGs）对于在医学中建立标准化和基于证据的方法至关重要。这些指南依赖于使用方法学上合理的临床试验，并随后报告其方法。
评估美国骨科医师学会（AAOS）发布的膝关节骨关节炎管理 CPG 所依据的随机对照试验（RCT）的完整性。
我们搜索了 AAOS 最近发布的关于膝关节骨关节炎手术和非手术治疗的 CPG 中 RCT。为了估计所需的样本量，我们使用 OpenEpi 3.0（openepi.com）进行了功效分析。
两位作者独立筛选了纳入 CPG 的参考文献部分。纳入的研究符合 RCT 的定义，可在英语中检索，并且至少在一份纳入的 CPG 中被引用。
Meta 分析。
1a 级。
我们对纳入 AAOS CPG 的 RCT 进行了双盲筛选和提取。我们评估了每个 RCT 是否符合 CONSORT 2010 清单。进行了多元回归分析，以评估纳入研究的特征（即干预类型、资金来源等）对 CONSORT 遵守情况的影响。
我们的研究纳入了 179 项 RCT。总体依从率为 68.5%，发表于 2010 年 CONSORT 指南前后的 RCT 之间存在显著差异（ = 0.02）。我们发现，从行业/私人来源获得资金的 RCT 以及包含利益冲突声明的研究比没有资金的 RCT 更完整（ < 0.01）。
我们发现 AAOS CGPs 中治疗膝关节骨关节炎的 RCT 存在 CONSORT 依从性不足的情况。因此，CPGs 可能基于过时的证据，缺乏高质量的报告。为了优化患者的结果，指导临床决策的证据必须是最高质量的。为了让临床医生为患者带来最大的益处，CPGs 应该提供全部证据，并强调新兴的高质量 RCT，以确保最新的、基于证据的临床决策。
