Centre for Health and Wellbeing Across the Lifecourse, Department of Health Sciences, Brunel University London, Uxbridge, UK.
Plymouth, UK.
J Pain. 2023 Dec;24(12):2103-2130. doi: 10.1016/j.jpain.2023.07.003. Epub 2023 Jul 13.
We previously conducted an exploration of the trustworthiness of a group of clinical trials of cognitive-behavioral therapy and exercise in spinal pain. We identified multiple concerns in 8 trials, judging them untrustworthy. In this study, we systematically explored the impact of these trials ("index trials") on results, conclusions, and recommendations of systematic reviews and clinical practice guidelines (CPGs). We conducted forward citation tracking using Google Scholar and the citationchaser tool, searched the Guidelines International Network library and National Institute of Health and Care Excellence archive to June 2022 to identify systematic reviews and CPGs. We explored how index trials impacted their findings. Where reviews presented meta-analyses, we extracted or conducted sensitivity analyses for the outcomes of pain and disability, to explore how the exclusion of index trials affected effect estimates. We developed and applied an 'Impact Index' to categorize the extent to which index studies impacted their results. We included 32 unique reviews and 10 CPGs. None directly raised concerns regarding the veracity of the trials. Across meta-analyses (55 comparisons), the removal of index trials reduced effect sizes by a median of 58% (Inter Quartlie Range (IQR) 40-74). 85% of comparisons were classified as highly, 3% as moderately, and 11% as minimally impacted. Nine out of 10 reviews conducting narrative synthesis drew positive conclusions regarding the intervention tested. Nine out of 10 CPGs made positive recommendations for the intervention(s) evaluated. This cohort of trials, with concerns regarding trustworthiness, has substantially impacted the results of systematic reviews and guideline recommendations. PERSPECTIVE: We found that a group of trials of CBT for spinal pain with concerns relating to their trustworthiness has had substantial impacts on the analyses and conclusions of systematic reviews and clinical practice guidelines. This highlights the need for a greater focus on the trustworthiness of studies in evidence appraisal. PRE-REGISTRATION: Our protocol was preregistered on the Open Science Framework: https://osf.io/m92ax/.
我们之前对一组关于认知行为疗法和运动治疗脊柱疼痛的临床试验的可信度进行了探索。我们在 8 项试验中发现了多个问题，认为这些试验不可信。在这项研究中，我们系统地探讨了这些试验（“索引试验”）对系统评价和临床实践指南（CPG）的结果、结论和建议的影响。我们使用 Google Scholar 和 citationchaser 工具进行了前瞻性引文追踪，搜索了 Guidelines International Network 图书馆和 National Institute of Health and Care Excellence 档案，截至 2022 年 6 月，以确定系统评价和 CPG。我们探讨了索引试验如何影响其发现。对于呈现荟萃分析的综述，我们提取或进行了疼痛和残疾结局的敏感性分析，以探讨排除索引试验如何影响效应估计。我们开发并应用了“影响指数”来分类索引研究对其结果的影响程度。我们纳入了 32 项独特的综述和 10 项 CPG。没有一项直接对试验的真实性提出质疑。在荟萃分析中（55 项比较），去除索引试验将效应大小中位数降低了 58%（四分位距（IQR）40-74）。85%的比较被归类为高度影响，3%为中度影响，11%为轻度影响。10 项综述中有 9 项进行了叙述性综合，对所测试的干预措施得出了积极的结论。10 项 CPG 中有 9 项对评估的干预措施提出了积极建议。这组有可信度问题的试验对系统评价和指南建议的分析和结论产生了重大影响。观点：我们发现，一组关于脊柱疼痛的认知行为疗法的试验，由于其可信度存在问题，对系统评价和临床实践指南的分析和结论产生了重大影响。这凸显了在证据评估中更加关注研究可信度的必要性。预注册：我们的方案在 Open Science Framework 上进行了预注册：https://osf.io/m92ax/。
