患者报告结局测量工具选择路径:以中国腰痛患者日常生活活动能力量表的选择为例

Selection Path of Patient-Reported Outcome Measures:a Case Study of Selecting an Activities of Daily Living Scale for Chinese Patients with Low Back Pain

患者报告结局测量工具(PROMs)是评价与量化患者报告结局的工具,而良好的测量性能是应用PROMs的基本前提条件,但PROMs数量众多,测量性能评价欠规范、不全面,因此如何选择合适的PROMs成为临床研究中亟待解决的问题之一。基于共识健康测量工具的选择标准(COSMIN)旨在帮助临床研究人员和医务工作者选择最合适的PROMs,本研究参考COSMIN并以中国腰痛患者日常生活活动能力量表的选择为例,探讨PROMs选择路径,发现PROMs选择路径主要包含以下5项主要内容:全面检索判断是否已有工具、研制/译制工具、工具测量性能研究、系统评价、改编工具,其中系统评价是PROMs选择路径中的关键;同时,PROMs的选择并非“一蹴而就”,而是一个循环向前的过程。

Patient-reported outcome measures(PROMs)are tools for evaluating and quantifying patient-reported outcomes,and qualified measurement properties is a basic prerequisite for their application.There have been a large number of PROMs,whose measurement properties have not been evaluated standardly and comprehensively,so how to select an appropriate PROM has become one problem that needs to be solved urgently in clinical research.COnsensus-based Standards for the selection of health Measurement INstruments(COSMIN)are designed to help researchers and medical workers choose the most appropriate outcome measurement.Referring to the COSMIN,we attempted to explore the selection path of PROMs for Chinese patients via showcasing the process of selecting an activities of daily living scale for Chinese low back pain patients.We found that the path for selecting an PROM includes five main steps:(1)acomprehensive retrieval to determine the presence of targeted PROMs;(2)development of new PROMs or cross-cultural adaption of foreign PROMs;(3)research on measurement properties;(4)systematic review of the properties;(5)optimization of current PROMs.In particular,system review of the propertiesis emphasized as the critical step.Meanwhile,the selection of PROMs is not overnight,but a circular and forward process.