Establishing empirically derived non-inferiority margins for large-scale trials: An umbrella review of meta-analytic comparisons of bona fide psychological therapies.

IF 3 1区心理学 Q2 PSYCHOLOGY, CLINICAL

Psychotherapy Research Pub Date : 2026-04-09 DOI:10.1080/10503307.2026.2653992

Christoph Flückiger, Michael Barkham, Juan Martín Goméz Penedo

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引用次数: 0

Abstract

Objective: Setting non-inferiority margins has been problematic with decision making often appearing to be arbitrary. A pragmatic approach is to use the existing literature to provide empirical reference values for these margins. The current meta-analytic umbrella review estimates empirically derived non-inferiority margins for direct psychological therapy comparisons meeting bona fide conditions.

Methods: A systematic search identified meta-analytic estimates of bona fide comparisons for primary and secondary outcomes. We conducted multilevel meta-analyses of these estimates to obtain generalizable empirically derived point-estimate non-inferiority margins.

Results: Most patients included in the analyses represented populations commonly expected in outpatient psychological therapy settings. Overall, 46 meta-analytic standardized mean differences (SMD) nested in 19 meta-analyses (mean of 15.6 primary studies and 1302 participants in each meta-analysis) were identified to estimate generalizable non-inferiority margins. The estimated homogeneously distributed margins for the primary outcomes were SMD = -.17 (95% CI = -.21, -.13) and for secondary outcomes SMD = -.16 (95% CI = -.20, -.11), respectively.

Discussion: This study provides empirically derived estimates for non-inferiority margins that are generalizable to large-scale trials to differentiate between small but nuanced effects and negligible non-inferior effects. Research on bona fide psychological therapy that accepts working on small effects needs careful consideration of confounding effects.

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建立大规模试验的经验性非劣效性边际：对真正的心理治疗的meta分析比较的综合回顾。

目的：设置非劣效边缘一直有问题的决策往往显得武断。务实的方法是利用现有文献为这些边际提供经验参考值。当前的荟萃分析综述估计了直接心理治疗比较符合真实条件的经验推导的非劣效性边际。方法：系统搜索确定了主要和次要结果真实比较的元分析估计。我们对这些估计进行了多水平荟萃分析，以获得可推广的经验推导的点估计非劣效边际。结果：分析中包括的大多数患者代表了门诊心理治疗设置中通常期望的人群。总体而言，在19项荟萃分析（每个荟萃分析中15.6项主要研究和1302名参与者的平均值）中嵌套了46项荟萃分析标准化平均差异（SMD），以估计可推广的非劣效边际。估计主要结局的均匀分布边际为SMD = - 0.17（95% CI = - 0.21, - 0.13），次要结局SMD = - 0.16（95% CI = - 0.20, - 0.11）。讨论：本研究提供了经验推导的非劣效边际估计，可推广到大规模试验，以区分微小但细微的效应和可忽略的非劣效效应。研究真正的心理治疗，接受小效果的工作，需要仔细考虑混杂效应。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Psychotherapy Research PSYCHOLOGY, CLINICAL-

CiteScore

7.80

自引率

10.30%

发文量

期刊介绍： Psychotherapy Research seeks to enhance the development, scientific quality, and social relevance of psychotherapy research and to foster the use of research findings in practice, education, and policy formulation. The Journal publishes reports of original research on all aspects of psychotherapy, including its outcomes, its processes, education of practitioners, and delivery of services. It also publishes methodological, theoretical, and review articles of direct relevance to psychotherapy research. The Journal is addressed to an international, interdisciplinary audience and welcomes submissions dealing with diverse theoretical orientations, treatment modalities.