Xie Wanling, Halabi Susan, Tierney Jayne F, Sydes Matthew R, Collette Laurence, Dignam James J, Buyse Marc, Sweeney Christopher J, Regan Meredith M
JNCI Cancer Spectr. 2019 Feb 6;3(1):pkz002. doi: 10.1093/jncics/pkz002. eCollection 2019 Mar.
Meta-analysis of randomized controlled trials (RCTs) has been widely conducted for the evaluation of surrogate endpoints in oncology, but little attention has been given to the adequacy of reporting and interpretation. This review evaluated the reporting quality of published meta-analyses on surrogacy evaluation and developed recommendations for future reporting.
We searched PubMed through August 2017 to identify studies that evaluated surrogate endpoints using the meta-analyses of RCTs in oncology. Both individual patient data (IPD) and aggregate data (AD) meta-analyses were included for the review.
Eighty meta-analyses were identified: 22 used IPD and 58 used AD from multiple RCTs. We observed variability and reporting deficiencies in both IPD and AD meta-analyses, especially on reporting of trial selection, endpoint definition, study and patient characteristics for included RCTs, and important statistical methods and results. Based on these findings, we proposed a checklist and recommendations to improve completeness, consistency, and transparency of reports of meta-analytic surrogacy evaluation. We highlighted key aspects of the design and analysis of surrogate endpoints and presented explanations and rationale why these items should be clearly reported in surrogacy evaluation.
Our reporting of surrogate endpoint evaluation using meta-analyses (ReSEEM) guidelines and recommendations will improve the quality in reporting and facilitate the interpretation and reproducibility of meta-analytic surrogacy evaluation. Also, they should help promote greater methodological consistency and could also serve as an evaluation tool in the peer review process for assessing surrogacy research.
随机对照试验（RCT）的荟萃分析已广泛用于评估肿瘤学中的替代终点，但对报告和解释的充分性关注较少。本综述评估了已发表的关于替代指标评估的荟萃分析的报告质量，并为未来报告提出了建议。
我们检索了截至2017年8月的PubMed，以识别使用肿瘤学RCT荟萃分析评估替代终点的研究。纳入综述的既有个体患者数据（IPD）荟萃分析，也有汇总数据（AD）荟萃分析。
共识别出80项荟萃分析：22项使用IPD，58项使用多个RCT的AD。我们在IPD和AD荟萃分析中均观察到变异性和报告缺陷，尤其是在试验选择、终点定义、纳入RCT的研究和患者特征以及重要统计方法和结果的报告方面。基于这些发现，我们提出了一份清单和建议，以提高荟萃分析替代指标评估报告的完整性、一致性和透明度。我们强调了替代终点设计和分析的关键方面，并说明了为什么这些项目应在替代指标评估中清晰报告的解释和理由。
我们的使用荟萃分析评估替代终点的报告（ReSEEM）指南和建议将提高报告质量，并促进荟萃分析替代指标评估的解释和可重复性。此外，它们应有助于促进更大的方法学一致性，也可作为同行评审过程中评估替代指标研究的评估工具。
