Department of Psychology, Royal Holloway, University of London, London, UK.
BMC Med Res Methodol. 2011 Jan 31;11:14. doi: 10.1186/1471-2288-11-14.
Current methodological guidelines provide advice about the assessment of sub-group analysis within RCTs, but do not specify explicit criteria for assessment. Our objective was to provide researchers with a set of criteria that will facilitate the grading of evidence for moderators, in systematic reviews.
We developed a set of criteria from methodological manuscripts (n = 18) using snowballing technique, and electronic database searches. Criteria were reviewed by an international Delphi panel (n = 21), comprising authors who have published methodological papers in this area, and researchers who have been active in the study of sub-group analysis in RCTs. We used the Research ANd Development/University of California Los Angeles appropriateness method to assess consensus on the quantitative data. Free responses were coded for consensus and disagreement. In a subsequent round additional criteria were extracted from the Cochrane Reviewers' Handbook, and the process was repeated.
The recommendations are that meta-analysts report both confirmatory and exploratory findings for sub-groups analysis. Confirmatory findings must only come from studies in which a specific theory/evidence based a-priori statement is made. Exploratory findings may be used to inform future/subsequent trials. However, for inclusion in the meta-analysis of moderators, the following additional criteria should be applied to each study: Baseline factors should be measured prior to randomisation, measurement of baseline factors should be of adequate reliability and validity, and a specific test of the interaction between baseline factors and interventions must be presented.
There is consensus from a group of 21 international experts that methodological criteria to assess moderators within systematic reviews of RCTs is both timely and necessary. The consensus from the experts resulted in five criteria divided into two groups when synthesising evidence: confirmatory findings to support hypotheses about moderators and exploratory findings to inform future research. These recommendations are discussed in reference to previous recommendations for evaluating and reporting moderator studies.
目前的方法学指南为 RCT 中的亚组分析评估提供了建议，但并未为评估指定明确的标准。我们的目的是为研究人员提供一套标准，以方便对系统评价中的调节因素进行证据分级。
我们使用滚雪球技术和电子数据库搜索从方法学文献（n=18）中制定了一套标准。标准由一个由 21 名作者组成的国际德尔菲小组进行了审查，这些作者在该领域发表了方法学论文，并且在 RCT 中的亚组分析研究方面非常活跃。我们使用研究与开发/加利福尼亚大学洛杉矶分校适用性方法来评估对定量数据的共识。对共识和分歧的自由回复进行了编码。在随后的一轮中，从 Cochrane 评论者手册中提取了其他标准，并重复了该过程。
建议是，荟萃分析员报告亚组分析的验证性和探索性结果。验证性结果必须仅来自进行了特定理论/基于证据的事先声明的研究。探索性结果可用于为未来/随后的试验提供信息。但是，为了将调节因素纳入荟萃分析，应将以下附加标准应用于每项研究：基线因素应在随机分组之前进行测量，基线因素的测量应具有足够的可靠性和有效性，并且必须提出基线因素与干预之间相互作用的特定检验。
21 名国际专家达成共识，认为及时且有必要为 RCT 系统评价中的调节因素制定方法学标准。专家们的共识导致了五项标准，分为两组来综合证据：验证性结果支持关于调节因素的假设，而探索性结果则为未来的研究提供信息。这些建议与之前评估和报告调节因素研究的建议进行了讨论。
