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

心理疗法的临床试验在所有心理健康临床试验中占有相当大的比例。然而，在设计或分析中明确考虑治疗师的相对较少。这对审判结果和结论的精确度、混乱性和概括性有严重影响。这项拟议的研究旨在(I)审查目前对心理治疗试验的设计、分析和报告以及对心理治疗试验的系统审查中治疗师效果的理解；(Ii)调整和评估在分组随机对照试验中使用的统计方法，以便将治疗师的差异纳入心理治疗试验的荟萃分析。这项研究将涉及对已发表的试验和模拟工作中的数据进行二次分析。预计将根据这项工作对报告非药理学试验的新的COOSE指南进行评估，就像现有的MOOSE系统审查报告指南一样。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审查。

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.