研究骨关节炎非手术疗法的随机对照试验经常使用具有误导性和缺乏信息的对照组:系统回顾。

IF 4.2 2区 医学 Q1 ORTHOPEDICS
Yaw Adu,David Ring,Teun Teunis
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引用次数: 0

摘要

背景由于目前尚无可改变骨关节炎病理生理学自然病程的已知治疗方法,因此需要将非手术治疗与旨在减轻症状的已知有效治疗方法或类似的侵入性惰性(安慰剂)治疗方法进行比较,以确定其有效性。将治疗方法与信息不全的对照组进行比较可能会不适当地使可能无效的治疗方法合法化并支持其使用。因此,我们调查了肌肉骨骼研究中不适当对照组的普遍性,并询问这些对照组是否与报告积极的治疗效果有关。问题/观点我们系统回顾了骨关节炎非手术疗法的随机试验,并询问:(1) 使用无信息对照组的随机试验占多大比例(定义为比试验疗法侵袭性更小的疗法,或可能不优于安慰剂但未被承认的疗法)?(2)使用无信息对照组是否与报告积极的治疗效果(定义为 p < 0.05 有利于干预治疗,或提出有利于干预治疗而非对照治疗的建议)独立相关?我们排除了包含手术治疗组的研究。我们确定了 103 项符合资格标准的试验,共有 15,491 名患者参与。根据科克伦偏倚风险工具(Cochrane Risk of Bias Tool)第2版,60%的试验(n = 62)存在高偏倚风险。尽管纳入研究的偏倚风险较高令人担忧,但这并不能否定我们的设计;相反,它强调了一些研究可能会使用有缺陷的方法来推荐疗效未经证实的治疗方法,而这些方法超出了非特异性效果,因为所观察到的偏倚类型往往会增加所评估治疗方法的明显益处。结果在纳入的研究中,46%(103 项研究中的 47 项)的研究发现使用了不具信息性的对照组(侵袭性小于受测疗法的疗法,或疗效可能不优于安慰剂但不被承认的疗法)。在考虑了潜在的混杂因素后,报告阳性治疗效果与使用不具参考价值的对照组之间没有关联。偏倚风险较低的研究报告阳性治疗效果的可能性较低(OR 0.2 [95% 置信区间 0.05 至 0.9];P = 0.04,模型伪 R2 = 0.21)。结论最近的研究发现,模仿高水平证据的研究经常使用不具信息性的对照组,这些对照组没有充分考虑非特异性效应(与治疗的直接生理效应无关的感知治疗益处),这表明无效治疗极有可能合法化。这就提出了患者、临床医生、期刊同行评审员和期刊编辑的道德要求,即要求研究人员以充分、信息丰富的对照组为标准。对偏倚风险的认识和检查表可能会帮助患者和临床医生放弃基于看似高水平证据的新疗法,因为这些证据可能只会带来先天性、经济和心理伤害(尤其是虚假希望)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Randomized Controlled Trials Studying Nonoperative Treatments of Osteoarthritis Often Use Misleading and Uninformative Control Groups: A Systematic Review.
BACKGROUND Because there are no known treatments that alter the natural course of the pathophysiology of osteoarthritis, nonoperative treatment needs to be compared with known effective treatments that seek to mitigate symptoms or with similarly invasive inert (placebo) treatments to determine effectiveness. Comparing a treatment to an uninformative control group may inappropriately legitimize and support the use of potentially ineffective treatments. We therefore investigated the prevalence of inappropriate control groups in musculoskeletal research and asked whether these are associated with reporting a positive treatment effect. QUESTIONS/PURPOSES We systematically reviewed randomized trials of nonoperative treatments of osteoarthritis and asked: (1) What proportion of randomized trials use uninformative control groups (defined as a treatment less invasive than the tested treatment, or a treatment that might possibly not outperform placebo but is not acknowledged as such)? (2) Is the use of uninformative control groups independently associated with reporting a positive treatment effect (defined as p < 0.05 in favor of the intervention, or as making a recommendation favoring the intervention over the control treatment)? METHODS In a systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched PubMed, Cochrane, and Embase up to September 2023 for randomized controlled trials published between 2020 to 2022 that compared one or more nonoperative treatments for the symptoms of osteoarthritis. We excluded studies that contained a surgical treatment group. We identified 103 trials that met eligibility criteria, with a total of 15,491 patients. The risk of bias was high in 60% (n = 62) of trials using the Cochrane Risk of Bias Tool, version 2. Although the high risk of bias in the included studies is concerning, it does not invalidate our design; instead, it highlights that some studies may use flawed methods to recommend treatments with unproven effectiveness beyond nonspecific effects because the kinds of bias observed would tend to increase the apparent benefit of the treatment(s) being evaluated. We used logistic regression to test the association of uninformative control groups with a positive treatment effect, accounting for potential confounders such as conflict of interest and study bias using the Cochrane Risk of Bias score. RESULTS The use of uninformative control groups (treatments less invasive than the tested treatment, or treatments that might not outperform placebo but are not acknowledged as such) was found in 46% (47 of 103) of included studies. After accounting for potential confounding, there was no association between reporting positive treatment effects and the use of an uninformative control group. Studies with a low risk of bias had a lower likelihood of reporting a positive treatment effect (OR 0.2 [95% confidence interval 0.05 to 0.9]; p = 0.04, model pseudo R2 = 0.21). CONCLUSION The finding that recent studies that mimic high-level evidence often use uninformative control groups that do not adequately account for nonspecific effects (perceived treatment benefits unrelated to a treatment's direct physiological effects) points to a high risk of legitimizing ineffective treatments. This raises the ethical imperative for patients, clinicians, journal peer reviewers, and journal editors to hold researchers to the standard of an adequate, informative control group. Awareness and risk of bias checklists might help patients and clinicians forgo new treatments based on seemingly high-level evidence that may carry only iatrogenic, financial, and psychological harm (false hope, in particular). LEVEL OF EVIDENCE Level I, therapeutic study.
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来源期刊
CiteScore
7.00
自引率
11.90%
发文量
722
审稿时长
2.5 months
期刊介绍: Clinical Orthopaedics and Related Research® is a leading peer-reviewed journal devoted to the dissemination of new and important orthopaedic knowledge. CORR® brings readers the latest clinical and basic research, along with columns, commentaries, and interviews with authors.
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