患者决策辅助工具国际标准4.0版的引进与评估

Cross-cultural Adaptation and Assessment of the International Patient Decision Aids Standards v4.0 for Chinese Version

基于国内决策辅助工具研究缺乏公认统一的质量评价标准,严格遵循评估工具的跨文化引进指南,对患者决策辅助工具国际标准4.0英文版进行引进与评估。研究流程包括翻译、翻译整合、回译、召开专家共识会议确定初稿,进行问卷评估以及共识会议确定终稿。在评估阶段,采用5分制Likert评价表,邀请49名专家从明晰性、重要性和可行性三方面对44个条目进行评分。结果未进行条目增删,在共识会议上结合评估结果与专家意见完善并形成最终条目,使其符合我国语境,并为每个条目编写了案例与注释结合的“内容解读”。中文版评价标准将为国内知识转化学者、决策辅助工具制作与评价研究者提供指导与参考。

Due to the lack of a widely acknowledged standard for certifying and qualifying a decision-making aid in domestic researches, we strictly followed the cross-cultural introduction guidelines of self-reported outcomes, and introduced and evaluated the English version of International Patient Decision Aid Standards v4.0. The steps included translation, synthesis, back-translation, expert committee review to produce a pre-final version, pre-testing to assess understanding, and expert committee review of the pre-testing results before finalizing the items. During pre-testing, 49 experts were asked to assess the clarity, integrity and feasibility for each one of the 44 items on a Likert scale ranging from 1 to 5 points. Finally, we did not add or delete items, but adapted the items to fit in the Chinese context on a second consensus meeting considering pre-testing results and expert feedback to the open questions in the questionnaire. In addition, we supplemented each item with a genuine note that was either an example or an explanation to the item to facilitate understanding. The Chinese version of International Patient Decision Aid Standards v4.0 was expected to provide guidance and reference for domestic knowledge translation researchers and decision aid developers.