WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy
Institute of Public Health, Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland.
BMJ Open. 2024 Aug 13;14(8):e082652. doi: 10.1136/bmjopen-2023-082652.
Promoting mental health, preventing and treating mental disorders are critically important in public health, and many randomised controlled trials (RCTs) evaluate intervention strategies for these objectives. However, distinguishing promotion from prevention and from treatment RCTs is challenging. A tool to place studies along the promotion-to-treatment continuum in mental health research does not exist, leaving it to researchers and policymakers to decide on how to classify individual RCTs, which hinders evidence synthesis.
We present a protocol for the development of a new tool to assist researchers in distinguishing RCTs along the promotion-to-treatment continuum. We will establish a Tool Development Group, and use the Population, Intervention, Comparison and Outcome framework to define constructs. We will generate, define, categorise and reduce the items in the tool using qualitative methods, including cognitive interviews and a Delphi exercise. Psychometric evaluation-including unidimensionality, local independence, monotonicity and item homogeneity-will include data collection, scoring, internal consistency checks and factor analysis of the tool's indicators for available RCTs. We will use standard Cohen's kappa statistics to assess the reliability of the tool.
This study involves data collection from the already published literature. However, this protocol has been approved by the ethics committee of the Università della Svizzera Italiana (CE 2024 04). The results of the present project will be disseminated in peer-reviewed journals and at international and national scientific meetings. Training materials for the application of the tool will also be developed and disseminated to the scientific community. The tool and all related implementation materials will be published on a website and will be freely accessible to the public.
促进心理健康、预防和治疗精神障碍在公共卫生中至关重要，许多随机对照试验（RCT）评估了针对这些目标的干预策略。然而，区分促进、预防和治疗 RCT 具有挑战性。目前尚不存在用于将精神健康研究中的研究置于促进-治疗连续体上的工具，这使得研究人员和政策制定者不得不自行决定如何对个别 RCT 进行分类，从而阻碍了证据的综合。
我们提出了一个开发新工具的方案，以帮助研究人员区分 RCT 在促进-治疗连续体上的位置。我们将成立一个工具开发小组，并使用人群、干预、比较和结局框架来定义构建。我们将使用定性方法（包括认知访谈和德尔菲法）生成、定义、分类和简化工具中的项目。心理测量评估——包括维度性、局部独立性、单调性和项目同质性——将包括对现有 RCT 数据的工具指标进行数据收集、评分、内部一致性检查和因子分析。我们将使用标准的 Cohen's kappa 统计来评估工具的可靠性。
本研究涉及从已发表文献中收集数据。然而，本方案已获得瑞士意大利大学伦理委员会（CE 2024 04）的批准。本项目的结果将发表在同行评议的期刊上，并在国际和国家科学会议上发表。还将制定和传播该工具的应用培训材料，以提供给科学界。工具和所有相关的实施材料将在一个网站上发布，并将免费向公众开放。
