Xiangya School of Public Health, Central South University, 5/F, Xiangya School of Public Health, No. 238, Shang ma Yuan ling Alley, Kaifu district, Changsha, Hunan, China.
Xiangya School of Public Health, Central South University, 5/F, Xiangya School of Public Health, No. 238, Shang ma Yuan ling Alley, Kaifu district, Changsha, Hunan, China
BMJ. 2021 Apr 19;373:n736. doi: 10.1136/bmj.n736.
To assess the methodological quality of individual participant data (IPD) meta-analysis and to identify areas for improvement.
Systematic review.
Medline, Embase, and Cochrane Database of Systematic Reviews.
Systematic reviews with IPD meta-analyses of randomised controlled trials on intervention effects published in English.
323 IPD meta-analyses covering 21 clinical areas and published between 1991 and 2019 were included: 270 (84%) were non-Cochrane reviews and 269 (84%) were published in journals with a high impact factor (top quarter). The IPD meta-analyses showed low compliance in using a satisfactory technique to assess the risk of bias of the included randomised controlled trials (43%, 95% confidence interval 38% to 48%), accounting for risk of bias when interpreting results (40%, 34% to 45%), providing a list of excluded studies with justifications (32%, 27% to 37%), establishing an a priori protocol (31%, 26% to 36%), prespecifying methods for assessing both the overall effects (44%, 39% to 50%) and the participant-intervention interactions (31%, 26% to 36%), assessing and considering the potential of publication bias (31%, 26% to 36%), and conducting a comprehensive literature search (19%, 15% to 23%). Up to 126 (39%) IPD meta-analyses failed to obtain IPD from 90% or more of eligible participants or trials, among which only 60 (48%) provided reasons and 21 (17%) undertook certain strategies to account for the unavailable IPD.
The methodological quality of IPD meta-analyses is unsatisfactory. Future IPD meta-analyses need to establish an a priori protocol with prespecified data syntheses plan, comprehensively search the literature, critically appraise included randomised controlled trials with appropriate technique, account for risk of bias during data analyses and interpretation, and account for unavailable IPD.
评估个体参与者数据（IPD）荟萃分析的方法学质量，并确定需要改进的领域。
系统评价。
Medline、Embase 和 Cochrane 系统评价数据库。
发表于英文期刊的、包含干预效果的随机对照试验的 IPD 荟萃分析的系统评价。
共纳入 323 项 IPD 荟萃分析，涵盖 21 个临床领域，发表于 1991 年至 2019 年期间：270 项（84%）为非 Cochrane 综述，269 项（84%）发表于高影响因子（前四分之一）期刊。IPD 荟萃分析在使用令人满意的技术评估纳入的随机对照试验偏倚风险方面的一致性较低（43%，95%置信区间 38%至 48%），在解释结果时考虑偏倚风险（40%，34%至 45%），提供了一份附有理由的排除研究清单（32%，27%至 37%），制定了预先设定的方案（31%，26%至 36%），预先指定了评估总效应（44%，39%至 50%）和参与者-干预相互作用（31%，26%至 36%）的方法，评估并考虑潜在的发表偏倚（31%，26%至 36%），以及进行全面的文献检索（19%，15%至 23%）。多达 126 项（39%）的 IPD 荟萃分析未能从 90%或更多符合条件的参与者或试验中获取 IPD，其中只有 60 项（48%）提供了原因，21 项（17%）采取了某些策略来解释无法获得的 IPD。
IPD 荟萃分析的方法学质量不尽如人意。未来的 IPD 荟萃分析需要制定一个预先设定的数据综合计划的方案，全面检索文献，使用适当的技术对纳入的随机对照试验进行严格评价，在数据分析和解释过程中考虑偏倚风险，并解释无法获得的 IPD。
