Tang Matthew, Lun Kimberley K, Lewin Adriane M, Harris Ian A
School of Clinical Medicine, UNSW Medicine & Health, UNSW Sydney, Sydney, Australia.
The University of Sydney, Camperdown, Australia.
Bone Jt Open. 2024 Dec 4;5(12):1072-1080. doi: 10.1302/2633-1462.512.BJO-2024-0042.R1.
Systematic reviews of randomized controlled trials (RCTs) are the highest level of evidence used to inform patient care. However, it has been suggested that the quality of randomization in RCTs in orthopaedic surgery may be low. This study aims to describe the quality of randomization in trials included in systematic reviews in orthopaedic surgery.
Systematic reviews of RCTs testing orthopaedic procedures published in 2022 were extracted from PubMed, Embase, and the Cochrane Library. A random sample of 100 systematic reviews was selected, and all included RCTs were retrieved. To be eligible for inclusion, systematic reviews must have tested an orthopaedic procedure as the primary intervention, included at least one study identified as a RCT, been published in 2022 in English, and included human clinical trials. The Cochrane Risk of Bias-2 Tool was used to assess random sequence generation as 'adequate', 'inadequate', or 'no information'; we then calculated the proportion of trials in each category. We also collected data to test the association between these categories and characteristics of the RCTs and systematic reviews.
We included 917 unique RCTs. We found that 374 RCTs (40.8%) reported adequate sequence generation, 61 (6.7%) were inadequate, 410 (44.7%) lacked information, and 72 (7.9%) were observational studies incorrectly included as RCTs within the systematic review. Publication year, an author with statistical or epidemiological qualifications, and journal impact factor were each associated with adequate randomization. We found that 45 systematic reviews (45%) included at least one inadequately randomized RCT or an observational study incorrectly treated as a RCT.
There is evidence of a lack of random allocation in RCTs included in systematic reviews in orthopaedic surgery. The conduct of RCTs and systematic reviews should be improved to minimize the risk of bias from inadequate randomization in RCTs and mislabelling of non-randomized studies as RCTs.
随机对照试验（RCT）的系统评价是用于指导患者护理的最高级别证据。然而，有人提出骨科手术RCT的随机化质量可能较低。本研究旨在描述骨科手术系统评价中纳入试验的随机化质量。
从PubMed、Embase和Cochrane图书馆中提取2022年发表的测试骨科手术的RCT系统评价。随机抽取100篇系统评价，并检索所有纳入的RCT。要符合纳入条件，系统评价必须将骨科手术作为主要干预措施进行测试，至少包括一项被确定为RCT的研究，于2022年以英文发表，并包括人类临床试验。使用Cochrane偏倚风险-2工具将随机序列生成评估为“充分”、“不充分”或“无信息”；然后我们计算了每个类别中试验的比例。我们还收集了数据以检验这些类别与RCT及系统评价特征之间的关联。
我们纳入了917项独特的RCT。我们发现374项RCT（40.8%）报告了充分的序列生成，61项（6.7%）不充分，410项（44.7%）缺乏信息，72项（7.9%）是在系统评价中被错误地作为RCT纳入的观察性研究。发表年份、具有统计学或流行病学资质的作者以及期刊影响因子均与充分随机化相关。我们发现45篇系统评价（45%）至少包括一项随机化不充分的RCT或一项被错误地当作RCT的观察性研究。
有证据表明骨科手术系统评价中纳入的RCT存在随机分配不足的情况。应改进RCT和系统评价的实施，以尽量减少RCT随机化不足和将非随机研究错误标记为RCT所导致的偏倚风险。
