临床研究中的治疗意图分析:临床医生的基本概念
Susan Armijo-Olivo1, Jordana Barbosa-Silva, Ester Moreira de Castro-Carletti
1From 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).
治疗意图分析对于准确的随机对照试验在康复中至关重要. 对此分析的误解可能导致医疗保健决策有缺陷,强调需要明确的报告标准.
科学领域:
- 康复医学 康复医学 康复医学
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
背景情况:
- 意图治疗 (ITT) 分析是随机对照试验 (RCT) 的基本原则.
- 在卫生文献中对ITT的各种定义和应用可能导致误解.
- 不一致的ITT应用可能会导致误导性发现,影响医疗保健决策.
研究的目的:
- 在康复RCT中批判性地评估治疗意图分析的应用.
- 综合目前对ITT的理解,包括定义,优点和缺点.
- 为临床研究中ITT的标准化报告提供建议.
主要方法:
- 方法审查遵循系统审查和元分析 (PRISMA) 准则的首选报告项目.
- 使用电子和手动策略进行全面的文献搜索.
- 根据资格标准,两名独立审查员选了标题,摘要和全文.
主要成果:
- 卫生文献对治疗意图分析提出了多种不同的定义.
- 由于定义含糊不清,ITT的错误应用可能会损害RCT结果的完整性.
- 缺乏关于参与者学和缺失数据管理的标准化报告加剧了这个问题.
结论:
- 对于使用的特定治疗意图定义的明确和一致的报告至关重要.
- 作者必须详细说明参与者消耗和处理缺失数据的方法.
- 遵守报告准则,如综合报告试验标准 (CONSORT),对于准确的ITT分析和可靠的医疗保健决策至关重要.
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