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

doi:10.12114/j.issn.1007-9572.2021.02.068

摘要/Abstract

摘要： 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。

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关键词: 腰痛, 患者报告结局评价, 基于共识健康测量工具的选择标准, 患者报告结局测量工具, 系统评价

Abstract: 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.
Low back pain；Patient reported outcome measures；COnsensus-based Standards for the selection of health Measurement Instruments；Patient-Reported Outcome Measures；Systematic reviews

陈千吉,陈红,张英,等. 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[J]. 中国全科医学, 2021, 24(36): 4648-4652. DOI: 10.12114/j.issn.1007-9572.2021.02.068.

CHEN Qianji, CHEN Hong, ZHANG Ying, WAN Ying, ZHOU Yanji, AN Yi, SUN Yanan, YU Changhe. 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　[J]. Chinese General Practice, 2021, 24(36): 4648-4652.

图/表 3

图1 PROMs选择路径

Figure 1 Selection path of PROMs

图2 中国腰痛患者ADLS的选择路径

Figure 2 Selection path of ADLS for Chinese patients with low back pain

表1 RADL量表系统评价[5]的改进GRADE证据质量评级

Table 1 Evidence quality of systematic reviews of RADL Scale based on modified GRADE approach

RADL量表	偏倚风险	不一致性	不准确性	间接性	最终证据质量分级
重测信度	降3级	降0级	降2级	降0级	极低
内部一致性	降0级	降0级	降1级	降0级	中等
聚合效度	降2级	降0级	降1级	降0级	极低

参考文献 16

[1]	U.S.Department of Health and Human Services FDA Center for Drug Evaluation and Research, U.S.Department of Health and Human Services FDA Center for Biologics Evaluation and Research, U.S.Department of Health and Human Services FDA Center for Devices and Radiological Health.Guidance for industry：patient-reported outcome measures：use in medical product development to support labeling claims：draft guidance[J].Health Qual Life Outcomes，2006，4:79.DOI：10.1186/1477-7525-4-79.
[2]	隆莉芝，袁玲.患者报告结局的应用近况及思考[J].中国全科医学，2020，23(32):4120-4127.DOI：10.12114/j.issn.1007-9572.2020.00.015.
[3]	MOKKINK L B, PRINSEN C A C, BOUTER L M，et al.The COnsensus-based Standards for the selection of health Measurement INstruments（COSMIN）and how to select an outcome measurement instrument[J].Braz J Phys Ther，2016 ，20(2):105-113.DOI：10.1590/bjpt-rbf.2014.0143.
[4]	MOKKINK L B, TERWEE C B, PATRICK D L，et al.The COSMIN study reached international consensus on taxonomy，terminology，and definitions of measurement properties for health-related patient-reported outcomes[J].J Clin Epidemiol，2010，63(7):737-745.DOI：10.1016/j.jclinepi.2010.02.006.
[5]	徐军.急性腰痛康复评定新量表——ADL恢复量表和功能性能力自信量表[J].国外医学（物理医学与康复学分册），1999，19(3):125-128.
[6]	BEATON D E, BOMBARDIER C, GUILLEMIN F，et al.Guidelines for the process of cross-cultural adaptation of self-report measures[J].Spine（Phila Pa 1976），2000，25(24):3186-3191.DOI：10.1097/00007632-200012150-00014.
[7]	刘保延.患者报告结局的测量：原理，方法与应用[M].北京：人民卫生出版社，2011.
[8]	MOKKINK L B, DE VET H C W, PRINSEN C A C，et al.COSMIN risk of bias checklist for systematic reviews of patient-reported outcome measures[J].Qual Life Res，2018，27(5):1171-1179.DOI：007/s11136-017-1765-4.
[9]	TERWEE C B, PRINSEN C A C, CHIAROTTO A，et al.COSMIN methodology for evaluating the content validity of patient-reported outcome measures：a Delphi study[J].Qual Life Res，2018，27(5):1159-1170.DOI：10.1007/s11136-018-1829-0.
[10]	MOKKINK L B, PRINSEN C A, PATRICK D L，et al.COSMIN methodology for assessing the content validity of PROMs -user manual[EB/OL]. [2021-03-20]. .
[11]	PRINSEN C A, VOHRA S, ROSE M R，et al.How to select outcome measurement instruments for outcomes included in a "Core Outcome Set"——a practical guideline[J].Trials，2016，17(1):449.DOI：10.1186/s13063-016-1555-2.
[12]	TERWEE C B, BOT S D M, DE BOER M R，et al.Quality criteria were proposed for measurement properties of health status questionnaires[J].J Clin Epidemiol，2007，60(1):34-42.DOI：10.1016/j.jclinepi.2006.03.012.
[13]	MOKKINK L B, PRINSEN C A, PATRICK D L，et al.COSMIN methodology for systematic reviews of patient-user manual[EB/OL].[2021-03-20]. .
[14]	张璐嘉，李顺平.COSMIN系统综述指南应用简介[J].中国药物经济学，2020，15(1):5-7.DOI：10.12010/j.issn.1673-5846.2020.01.001.
[15]	彭健，沈蓝君，陈祎婷，等.对COSMIN-RoB清单中测量工具稳定性、测量误差和效标效度研究偏倚风险的清单解读[J].中国循证医学杂志，2020，20(11):1340-1344.DOI：10.7507/1672-2531.202003164.
[16]	彭健，沈蓝君，陈祎婷，等.COSMIN-RoB清单简介及测量工具内部结构研究的偏倚风险清单解读[J].中国循证医学杂志，2020，20(10):1234-1240.DOI：10.7507/1672-2531.202003163.