Therapist Effects in the Design, Analysis and Reporting of Psychotherapy Randomised Clinical Trials

心理治疗临床试验在精神卫生领域开展的所有临床试验中占很大比例。然而，在设计或分析中明确考虑到治疗师的相对较少。这严重影响了试验结果和结论的准确性、混淆性和普遍性。本研究旨在(i)回顾目前对心理治疗试验设计、分析和报告中治疗师作用的理解，以及对心理治疗试验的系统回顾；（ii）适应和评估聚类随机对照试验背景下使用的统计方法，以便在心理治疗试验的荟萃分析中纳入治疗师的差异。这项研究将涉及对已发表的试验和模拟工作数据的二次分析。预计新的CONSORT非药物试验报告指南将根据这项工作进行评估，现有的MOOSE系统评价报告指南也将进行评估。这项工作预计将有助于提高未来心理治疗临床试验的质量和心理治疗试验的系统评价。

Clinical trials of psychotherapies make up a significant proportion of all clinical trials carried out in mental health. Yet relatively few explicitly take the therapist into account either in the design or in the analysis. This has serious implications for the precision, confounding and generalisability of the trial results and conclusions. The proposed research aims to (i) to review current understanding of therapist effects in the design, analysis and reporting of psychotherapy trials and systematic reviews of psychotherapy trials; (ii) to adapt and evaluate statistical approaches used in the context of cluster RCTs in order to incorporate therapist variation in meta-analyses of psychotherapy trials. The research will involve the secondary analysis of data from published trials and simulation work. It is expected that the new CONSORT guidelines for the reporting non-pharmacological trials will be evaluated in light of this work, as will existing MOOSE guidelines for the reporting of systematic reviews. This work is anticipated to help raise the quality of future clinical trials of psychotherapies and systematic reviews of psychotherapy trials.