From the University of Applied Sciences Osnabrück, Faculty of Economics and Social Sciences, Osnabrück, Germany (SA-O, AISDO-S, NB); Faculties of Rehabilitation Medicine and Medicine and Dentistry, University of Alberta, Edmonton, Canada (SA-O) Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, Canada; Post Graduate Program in Physical Therapy, Federal University of São Carlos-UFSCar, São Carlos, Brazil (JB-S); Post Graduate Program in Human Movement Sciences, Methodist University of Piracicaba-UNIMEP, Piracicaba, Brazil (EMDC-C); Post-Graduation Program in Oral and Maxillofacial Surgery, Piracicaba Dental School, State University of Campinas-UNICAMP, Piracicaba (SP), Brazil (EBP); Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, Canada (NM, FB, LD); Faculty of Health Science, Center of Physiotherapy, Universiti Teknologi MARA, Puncak Alam, Malaysia (NM); Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada (JPS); Toronto Rehabilitation Institute, University Health Network, Toronto, Canada (JPS); and Division of Physical Medicine and Rehabilitation, Department of Medicine, University of Toronto, Toronto, Canada (DK).
Am J Phys Med Rehabil. 2024 Sep 1;103(9):845-857. doi: 10.1097/PHM.0000000000002444. Epub 2024 Feb 6.
This review presents a comprehensive summary and critical evaluation of intention-to-treat analysis, with a particular focus on its application to randomized controlled trials within the field of rehabilitation. Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 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. In addition, 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 intention to treat, including its definition, common misconceptions, advantages, disadvantages, and key recommendations. Notably, the health literature offers a variety of definitions for intention to treat, which can lead to misinterpretations and inappropriate application when analyzing randomized controlled trial results, potentially resulting in misleading findings with significant implications for healthcare decision making. Authors should clearly report the specific intention-to-treat 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 for randomized controlled trials, is essential to standardize intention-to-treat information, ensuring the delivery of accurate and informative results for healthcare decision making.
这篇综述对意向治疗分析进行了全面总结和批判性评估，特别关注其在康复领域随机对照试验中的应用。我们遵循系统评价和荟萃分析的首选报告项目指南，进行了方法学综述，包括电子和手动搜索策略，以确定相关研究。我们的选择过程涉及两名独立的评审员，他们最初筛选标题和摘要，然后根据既定的入选标准进行全文筛选。此外，我们还包括了从第一作者个人数据库中已经编目的手动搜索中获得的研究。研究结果通过叙述方法进行综合，涵盖了意向治疗的基本方面，包括其定义、常见误解、优点、缺点和关键建议。值得注意的是，健康文献中对意向治疗有多种定义，这可能导致在分析随机对照试验结果时产生误解和不当应用，从而导致对医疗保健决策具有重大影响的误导性发现。作者应该在分析中明确报告使用的特定意向治疗定义，详细说明参与者脱落情况，并解释他们处理缺失数据的方法。报告指南的遵守，如随机对照试验的临床试验报告标准的一致性，对于标准化意向治疗信息至关重要，确保为医疗保健决策提供准确和有信息的结果。
