How to distinguish promotion, prevention and treatment trials in public mental health? Study protocol for the development of the VErona-LUgano Tool (VELUT).
Autor: | Purgato M; 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 marianna.purgato@univr.it., Albanese E; Institute of Public Health, Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland., Papola D; 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.; Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA., Prina E; 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., Tedeschi F; 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., Gross A; Johns Hopkins University Center on Aging and Health, Baltimore, Maryland, USA.; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Sijbrandij M; Department of Clinical, Neuro- and Developmental Psychology, VU University Amsterdam, Amsterdam, The Netherlands., Acarturk C; Department of Psychology, Koc University, Istanbul, Türkiye., Annoni AM; Institute of Public Health, Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland., Silva M; Lisbon Institute of Global Mental Health, NOVA University of Lisbon, Lisboa, Portugal., Jordans MJD; Health Service and Population Research Department, Centre for Global Mental Health, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.; Research and Development Department, War Child, Amsterdam, the Netherlands.; Amsterdam Institute for Social Science Research, University of Amsterdam, Amsterdam, the Netherlands., Lund C; Health Service and Population Research Department, Centre for Global Mental Health, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.; Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa., Tol WA; Global Health Section, University of Copenhagen, Kobenhavn, Denmark.; Athena Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands., Cuijpers P; Department of Clinical, Neuro- and Developmental Psychology, VU University Amsterdam, Amsterdam, The Netherlands., Barbui C; 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. |
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Jazyk: | angličtina |
Zdroj: | BMJ open [BMJ Open] 2024 Aug 13; Vol. 14 (8), pp. e082652. Date of Electronic Publication: 2024 Aug 13. |
DOI: | 10.1136/bmjopen-2023-082652 |
Abstrakt: | Introduction: 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. Methods and Analysis: 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. Ethics and Dissemination: 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. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.) |
Databáze: | MEDLINE |
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