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ABSTRACT: Objective
Harmonized tools are essential for reliable data sharing and accurate identification of relevant factors in mental health research. The primary objective of this study was to create a harmonized questionnaire to collect demographic, clinical and behavioral data in diverse clinical trials in adult psychiatry.Methods
We conducted a literature review and examined 24 questionnaires used in previously published randomized controlled trials in psychiatry, identifying a total of 27 domains previously explored. Using a Delphi-method process, a task force team comprising experts in psychiatry, epidemiology and statistics selected 15 essential domains for inclusion in the final questionnaire.Results
The final selection resulted in a concise set of 22 questions. These questions cover factors such as age, sex, gender, ancestry, education, living arrangement, employment status, home location, relationship status, and history of medical and mental illness. Behavioral factors like physical activity, diet, smoking, alcohol and illicit drug use were also included, along with one question addressing family history of mental illness. Income was excluded due to high confounding and redundancy, while language was included as a measure of migration status.Conclusion
The recommendation and adoption of this harmonized tool for the assessment of demographic, clinical and behavioral data in mental health research can enhance data consistency and enable comparability across clinical trials.
SUBMITTER: Lotfaliany M
PROVIDER: S-EPMC11308274 | biostudies-literature | 2024 Aug
REPOSITORIES: biostudies-literature
Lotfaliany Mojtaba M Agustini Bruno B Walker Adam J AJ Turner Alyna A Wrobel Anna L AL Williams Lana J LJ Dean Olivia M OM Miles Stephanie S Rossell Susan L SL Berk Michael M Mohebbi Mohammadreza M
The Australian and New Zealand journal of psychiatry 20240606 8
<h4>Objective</h4>Harmonized tools are essential for reliable data sharing and accurate identification of relevant factors in mental health research. The primary objective of this study was to create a harmonized questionnaire to collect demographic, clinical and behavioral data in diverse clinical trials in adult psychiatry.<h4>Methods</h4>We conducted a literature review and examined 24 questionnaires used in previously published randomized controlled trials in psychiatry, identifying a total ...[more]