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Intention to treat analysis in clinical research: basis concepts for clinicians

  • This review presents a comprehensive summary and critical evaluation of Intention to Treat (ITT) analysis, with a particular focus on its application to randomized controlled trials (RCTs) within the field of rehabilitation. Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we conducted a methodological review that encompassed electronic and manual search strategies to identify relevant studies. Our selection process involved two independent reviewers who initially screened titles and abstracts and subsequently performed full-text screening based on established eligibility criteria. Additionally, we included studies from manual searches that were already cataloged within the first author’s personal database. The findings are synthesized through a narrative approach, covering fundamental aspects of ITT, including its definition, common misconceptions, advantages, disadvantages, and key recommendations. Notably, the health literature offers a variety of definitions for ITT, which can lead to misinterpretations and inappropriate application when analyzing RCT results, potentially resulting in misleading findings with significant implications for healthcare decision-making. Authors should clearly report the specific ITT definition used in their analysis, provide details on participant dropouts, and explain upon their approach to managing missing data. Adherence to reporting guidelines, such as the Consolidated Standards of Reporting Trials (CONSORT) for RCTs, is essential to standardize ITT information, ensuring the delivery of accurate and informative results for healthcare decision-making.

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Author:Susan Armijo-OlivoORCiD, Jordana Barbosa da Silva, Ester Moreira de Castro-CarlettiORCiD, Ana Izabela Sobral de Oliveira-SouzaORCiD, Elisa Bizetti Pelai, Norazlin MohamadORCiD, Fatemeh Baghbani-Naghadehi, Liz DennettORCiD, Jeremy P Steen, Dinesh Kumbhare, Nikolaus BallenbergerORCiD
Title (English):Intention to treat analysis in clinical research: basis concepts for clinicians
Parent Title (English):American Journal of Physical Medicine & Rehabilitation
Document Type:Article
Year of Completion:2024
Release Date:2024/06/06
Faculties:Fakultät WiSo
DDC classes:600 Technik, Medizin, angewandte Wissenschaften / 610 Medizin, Gesundheit
Collections:nur Publikationsnachweis
Review Status:Peer Reviewed