个体内临床试验报告规范(CONSORT for WPT)解读

Interpretation of the Consolidated Standards of Reporting Trials(CONSORT) guideline for within person trials

个体内临床试验(within person trial)是一种高效的随机对照试验研究设计,广泛应用于口腔医学、皮肤病学和眼科学领域。然而,由于存在一系列特有方法学难点,个体内临床试验的设计、实施与报告往往需要研究人员具备更多方法学知识、进行更全面的考量。为规范和提高这类临床试验的报告质量,BMJ近期发表了临床试验报告统一标准:个体内临床试验扩展声明(CONSORT for Within Person Trials)。本文旨在对CONSORT for WPT进行解读,以促进其在国内研究人员中的理解与应用。

Within person trial is an efficient study design for randomized controlled trials which has been widely used in fields of dentistry, dermatology and ophthalmology. However, due to a series of inherent methodological difficulties, the design, conduct and reporting of within person trials usually requires additional methodological knowledge and considerations from researchers. To standardize and improve the reporting quality of these trials, the BM] recently published the CONSORT statement extension for within person trials. The present article aimed to provide interpretation of this reporting guideline, and thereby promote its understanding and use among Chinese researchers.