Data_Sheet_1_Reading, Conducting, and Developing Systematic Review and Individual Patient Data Meta-Analyses in Psychiatry for Treatment Issues.docx

Introduction: Individual participant data meta-analyses (IPD-MAs) include the raw data from relevant randomised clinical trials (RCTs) and involve secondary analyses of the data. Performed since the late 1990s, ~50 such meta-analyses have been carried out in psychiatry, mostly in the field of treatment. IPD-MAs are particularly relevant for three objectives: (1) evaluation of the average effect of an intervention by combining effects from all included trials, (2) evaluation of the heterogeneity of an intervention effect and sub-group analyses to approach personalised psychiatry, (3) mediation analysis or surrogacy evaluation to replace a clinical (final) endpoint for the evaluation of new treatments with intermediate or surrogate endpoints. The objective is to describe the interest and the steps of an IPD-MA method applied to the field of psychiatric therapeutic research.Method: The method is described in three steps. First, the identification of the relevant trials with an explicit description of the inclusion/exclusion criteria for the RCT to be incorporated in the IPD-MA and a definition of the intervention, the population, the context and the relevant points (outcomes or moderators). Second, the data management with the standardisation of collected variables and the evaluation and the assessment of the risk-of-bias for each included trial and of the global risk. Third, the statistical analyses and their interpretations, depending on the objective of the meta-analysis. All steps are illustrated with examples in psychiatry for treatment issues, excluding study protocols.Conclusion: The meta-analysis of individual patient data is challenging. Only strong collaborations between all stakeholders can make such a process efficient. An “ecosystem” that includes all stakeholders (questions of interest prioritised by the community, funders, trialists, journal editors, institutions, …) is required. International medical societies can play a central role in favouring the emergence of such communities.

引言：个体参与者数据荟萃分析（IPD-MAs）涵盖了相关随机对照试验（RCTs）的原始数据，并涉及对这些数据的二次分析。自1990年代末以来，在精神病学领域，尤其是治疗领域，已进行了约50项此类荟萃分析。IPD-MAs对于以下三个目标尤为相关：（1）通过结合所有纳入试验的效果来评估干预措施的总体效应，（2）评估干预措施效果的异质性和亚组分析，以推进个性化精神病学，（3）中介分析或替代终点评估，以替代临床（最终）终点，用于评估具有中间或替代终点的新的治疗方法。目标是描述应用于精神病学治疗研究领域中的IPD-MA方法的兴趣及其步骤。方法：该方法分为三个步骤进行描述。首先，识别相关试验，明确描述纳入/排除标准以及RCT在IPD-MAs中的定义、干预措施、人群、情境和相关要点（结果或调节因素）。其次，数据管理，包括收集变量的标准化以及评估每个纳入试验和整体偏倚风险。第三，统计分析和其解释，取决于荟萃分析的目标。所有步骤均以精神病学治疗问题的示例进行说明，不包括研究方案。结论：个体患者数据的荟萃分析颇具挑战性。只有所有利益相关者之间的紧密合作才能使此过程高效。需要一个包括所有利益相关者（由社区、资助者、试验者、期刊编辑、机构等优先考虑的问题）“生态系统”，国际医学协会可以在促进此类社区的出现中扮演核心角色。