Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD 21205.
Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD 21205.
J Clin Epidemiol. 2017 Nov;91:95-110. doi: 10.1016/j.jclinepi.2017.07.014. Epub 2017 Aug 24.
The objective of this study was to determine whether disagreements among multiple data sources affect systematic reviews of randomized clinical trials (RCTs).
Eligible RCTs examined gabapentin for neuropathic pain and quetiapine for bipolar depression, reported in public (e.g., journal articles) and nonpublic sources (clinical study reports [CSRs] and individual participant data [IPD]).
We found 21 gabapentin RCTs (74 reports, 6 IPD) and 7 quetiapine RCTs (50 reports, 1 IPD); most were reported in journal articles (18/21 [86%] and 6/7 [86%], respectively). When available, CSRs contained the most trial design and risk of bias information. CSRs and IPD contained the most results. For the outcome domains "pain intensity" (gabapentin) and "depression" (quetiapine), we found single trials with 68 and 98 different meta-analyzable results, respectively; by purposefully selecting one meta-analyzable result for each RCT, we could change the overall result for pain intensity from effective (standardized mean difference [SMD] = -0.45; 95% confidence interval [CI]: -0.63 to -0.27) to ineffective (SMD = -0.06; 95% CI: -0.24 to 0.12). We could change the effect for depression from a medium effect (SMD = -0.55; 95% CI: -0.85 to -0.25) to a small effect (SMD = -0.26; 95% CI: -0.41 to -0.1).
Disagreements across data sources affect the effect size, statistical significance, and interpretation of trials and meta-analyses.
本研究旨在确定多个数据源之间的分歧是否会影响随机临床试验（RCT）的系统评价。
合格的 RCT 研究了加巴喷丁治疗神经性疼痛和喹硫平治疗双相抑郁，这些研究结果发表在公开（如期刊文章）和非公开（临床研究报告 [CSR] 和个体参与者数据 [IPD]）来源中。
我们发现了 21 项加巴喷丁 RCT（74 份报告，6 份 IPD）和 7 项喹硫平 RCT（50 份报告，1 份 IPD）；其中大多数发表在期刊文章中（分别为 18/21 [86%] 和 6/7 [86%]）。当可用时，CSR 包含最多的试验设计和偏倚风险信息。CSR 和 IPD 包含最多的结果。对于“疼痛强度”（加巴喷丁）和“抑郁”（喹硫平）这两个结局领域，我们发现单个试验分别有 68 和 98 个不同的可进行 meta 分析的结果；通过有目的地为每个 RCT 选择一个可进行 meta 分析的结果，我们可以改变疼痛强度的总体结果，从有效（标准化均数差 [SMD] = -0.45；95%置信区间 [CI]：-0.63 至 -0.27）变为无效（SMD = -0.06；95% CI：-0.24 至 0.12）。我们还可以改变抑郁的效果，从中等效应（SMD = -0.55；95% CI：-0.85 至 -0.25）变为小效应（SMD = -0.26；95% CI：-0.41 至 -0.1）。
数据源之间的分歧会影响试验和荟萃分析的效应大小、统计显著性和解释。
