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随机对照试验研究骨关节炎的非手术治疗方法 经常使用误导和不信息的对照组:系统性审查
Yaw Adu1, David Ring1, Teun Teunis2
1Department of Surgery and Perioperative Care, Dell Medical School, The University of Texas at Austin, Austin, TX, USA.
Clinical orthopaedics and related research
|October 25, 2024
概括
许多骨关节炎研究使用不适当的对照组,可能使无效的治疗合法化. 研究中偏差风险较低与较不积极的治疗效果报告有关.
科学领域:
- 整形外科和运动医学
- 临床试验方法论 临床试验方法论
- 基于证据的医学基于证据的医学.
背景情况:
- 骨关节炎治疗缺乏疾病修饰的选择,需要与有效的减轻症状或安慰剂治疗进行比较.
- 在研究中,不适当的对照组可以使潜在无效的关节炎治疗合法化.
- 这项研究调查了肌肉骨研究中的非信息对照组的流行情况及其与治疗效果报告的积极联系.
研究的目的:
- 确定在非手术性骨关节炎治疗研究中使用非信息控制组的随机试验的比例.
- 评估非信息性对照组是否与报告积极治疗效应的独立相关.
主要方法:
- 按照PRISMA指南,对非手术性骨关节炎治疗 (2020-2022) 的随机对照试验 (RCT) 的系统审查.
- 分析了103项试验 (15,491名患者);60%的人具有偏差的高风险.
- 使用后勤回归来评估非信息对照组与积极治疗效应之间的关联,控制利益冲突和偏见等混因素.
主要成果:
- 近一半 (46%) 的研究使用了无信息的对照组.
- 在调整了混因素后,没有发现缺乏信息的对照组与报告积极治疗效应之间的关联.
- 偏差风险较低的研究不太可能报告治疗的积极影响 (OR 0.2;P=0.04).
结论:
- 最近的骨关节炎研究经常使用无信息的对照组,冒着无效治疗方法的验证风险.
- 对于研究人员,临床医生和编辑来说,存在着道德上的必要要求,要求适当的,信息化的控制小组.
- 提高对偏见的认识和检查清单的使用可以帮助防止基于有缺陷的证据的治疗造成伤害.
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