中国全科医学 ›› 2024, Vol. 27 ›› Issue (29): 3672-3678.DOI: 10.12114/j.issn.1007-9572.2023.0519

• 医学循证 • 上一篇    

基于COSMIN指南对中国腰痛患者罗兰-莫里残疾调查问卷测量性能证据的系统评价

高艺轩1,2, 王锡友2, 陈千吉3, 杨晓明2, 郭俊明2, 訾一路2, 翁志文2, 马敬祎2, 章乃文2, 刘二杨2, 邵辉2, 孙亚男4, 于长禾2,*()   

  1. 1.100700 北京市,北京中医药大学第一临床医学院
    2.100700 北京市,北京中医药大学东直门医院推拿疼痛科
    3.518001 广东省深圳市罗湖区中医院
    4.100053 北京市,首都医科大学宣武医院中医科
  • 收稿日期:2023-07-14 修回日期:2023-11-28 出版日期:2024-10-15 发布日期:2024-07-16
  • 通讯作者: 于长禾

  • 作者贡献:

    高艺轩进行文章撰写,文献筛选;王锡友、孙亚男提供指导性支持;陈千吉进行文献筛选;杨晓明、郭俊明、刘二杨、邵辉负责文章内容、质量评价校对;訾一路、翁志文、马敬祎、章乃文负责方法学质量评价;于长禾负责方法学设计与文章质量监控,对论文负责。

  • 基金资助:
    国家自然科学基金青年科学基金项目(81803956); 北京市首发青年优才项目(2020-4-4195); 首都临床特色应用研究(Z181100001718165)

Roland-Morris Disability Questionnaire Measurement Performance Evidence in Chinese Patients with Low Back Pain: a Systematic Review Based on COSMIN Guidelines

GAO Yixuan1,2, WANG Xiyou2, CHEN Qianji3, YANG Xiaoming2, GUO Junming2, ZI Yilu2, WENG Zhiwen2, MA Jingyi2, ZHANG Naiwen2, LIU Eryang2, SHAO Hui2, SUN Yanan4, YU Changhe2,*()   

  1. 1. The First Clinical Department, Beijing University of Chinese Medicine, Beijing 100700, China
    2. Tuina and Pain Management Department, Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing 100700, China
    3. Shenzhen Luohu District Hospital of Traditional Chinese Medicine, Shenzhen 518001, China
    4. Traditional Chinese Medicine Department, Xuanwu Hospital Capital Medical University, Beijing 100053, China
  • Received:2023-07-14 Revised:2023-11-28 Published:2024-10-15 Online:2024-07-16
  • Contact: YU Changhe

摘要: 背景 腰痛全球患病率逐步上升,而腰痛是致残、病休、失业的主要原因,对个人及社会均是沉重的负担。评估慢性腰痛患者的残疾程度对于评价临床干预疗效和临床流行病学至关重要。罗兰-莫里残疾调查问卷(RMDQ)是目前评估腰痛患者残疾的主要工具,但其测量性能在中国人群中的适用性尚不明确。 目的 评估RMDQ在中国腰痛人群中的适用性,为临床实践、临床研究的应用提供证据。 方法 计算机检索中国知网、万方数据知识服务平台、中国生物医学文献服务系统、PubMed、Embase及Web of Science等,检索时间为建库至2023-10-01,针对腰痛量表的性能研究建立文献库,再从中筛选RMDQ测量性能的研究。按照健康测量工具选择的共识标准(COSMIN)系统评价指南对RMDQ的测量学性能进行评价,并采用GRADE证据评价等级对证据分级。 结果 共纳入6篇RMDQ文献,RMDQ内容效度方法学质量为不足,测量性能为充分;内部一致性方法学质量存在非常好与不确定,测量性能为充分;重测信度方法学质量为不确定,测量性能为充分;测量误差方法学质量为不确定,测量性能为充分;校标效度方法学质量为不确定,测量性能为不充分;假设检验方法学质量存在非常好与不确定,测量性能存在充分与不确定;反应度方法学质量存在非常好、足够与不足,测量性能存在充分与不足。根据GRADE证据质量评级结果表明内容效度有低质量证据证明不确定,重测信度及内部一致性有中等质量证据证明充分;测量误差及反应度有低质量证据证明充分;以Oswestry功能障碍指数(ODI)和视觉模拟量表(VAS)为校标时,校标效度有非常低质量证据证明不充分;假设检验有中等质量证据证明不确定。 结论 RMDQ方法学质量不高,测量性能尚可,证据质量偏低,在中国腰痛临床实践或试验中需谨慎使用,重测信度与内部一致性虽被中等质量证据证明充分,但研究内容和方法不规范。将来研究应注意规范,能更准确判断在中国人群中的适用性。

关键词: 腰痛, 罗兰-莫里残疾调查问卷, 健康测量工具选择的共识标准, 信度, 效度, 反应度

Abstract:

Background

The global prevalence of low back pain is gradually increasing, and it is the main cause of disability, sick leave, and unemployment, posing a heavy burden on individuals and society. Assessing the degree of disability in patients with chronic low back pain is crucial for evaluating the efficacy of clinical interventions and clinical epidemiology. The Roland-Morris Disability Questionnaire (RMDQ) is currently the main tool for evaluating disability in patients with low back pain, but the applicability of its measurement performance in the Chinese population remains unclear.

Objective

To evaluate the applicability of RMDQ in the Chinese population with low back pain and provide evidence for clinical practice and research application.

Methods

CNKI, Wanfang Data Knowledge Service Platform, SinoMed, PubMed, Embase and Web of Science were searched from inception to 2023-10-01, to establish a literature base for the performance of the low back pain scale, and then select research on the measurement performance of RMDQ from it. The measurement performance of the RMDQ scale was evaluated according to the COSMIN system evaluation guidelines, and the evidence evaluation level was used to grade the evidence.

Results

A total of six RMDQ documents were included, with insufficient methodological quality for RMDQ content validity and adequate measurement performance. The quality of internal consistency methodology was very good with uncertainty and measurement performance was adequate; the methodological quality of retesting was uncertain, and the measurement performance was sufficient; the methodological quality of measurement error was uncertain, and the measurement performance was sufficient; the methodological quality of criterion validity was uncertain, and the measurement performance was insufficient; hypothesis testing methodological quality was very good with uncertain, and the measurement performance was sufficient and uncertain; the quality of reactivity methodology was very good, with sufficient and insufficient, while the measurement performance was sufficient with insufficient. According to the GRADE evidence quality rating results, there is low quality evidence to prove uncertainty in content validity, and moderate quality evidence to prove sufficient retesting reliability and internal consistency; there is sufficient evidence of low quality to prove the measurement error and reactivity. There is very low quality evidence of insufficient calibration validity when using the Oswestry Dysfunction Index (ODI) and the Visual Analog Scale (VAS) as calibrators; hypothesis testing had moderate quality evidence of uncertainty.

Conclusion

The methodological quality of the RMDQ scale is not high, with acceptable measurement performanceand low quality of evidence, and needs to be used cautiously in clinical practice or trials of low back pain in China. Although there is sufficient evidence of moderate quality to prove the reliability and internal consistency of retesting, the research content and methods are not standardized. In future research, attention should be paid to standardization to more accurately assess its applicability in the Chinese population.

Key words: Low back pain, Roland-Morris Disability Questionnaire, COSMIN, Validity, Reliability, Responsiveness

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