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中国脊柱侧弯患者健康相关生活质量量表的测量属性:一项系统评价

Measurement properties of health-related quality of life instruments for people living with scoliosis in China: A systematic review.

作者信息

Jing Liu-Qing, Shen Qi-Xing, Jin Yi-Lin, Du Shao-Jie, Liu Ting-Zhen, Chen Ni, Wang Guo-Dong, Mo Wen, Ye Jie, Xu Jin-Hai

机构信息

Department of Orthopaedics, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Shanghai Spinal Diseases Institute of Traditional Chinese Medicine, Shanghai, China.

出版信息

PLoS One. 2025 Jun 26;20(6):e0325382. doi: 10.1371/journal.pone.0325382. eCollection 2025.

Abstract

PURPOSE

Scoliosis is a three-dimensional structural deformity of the spine that leads to restricted spinal motion, weakness in the paraspinal muscles, reduced cardiopulmonary function, and chronic physical and psychological pain. It also impacts patients' quality of life. According to statistics, as of 2022, the number of Chinese primary and secondary school students with scoliosis has exceeded 5 million, and continues to grow at an annual rate of approximately 300,000 new cases, while the incidence of scoliosis in adults is even higher. Therefore, it is crucial to evaluate health-related quality of life (HR-QoL) in this population. This systematic review examined the frequency of use of HR-QoL outcome measurement instruments among patients with scoliosis in China and synthesized evidence on their measurement properties.

METHODS

Stage 1: We searched databases including MEDLINE, EMBASE, Scopus, PubMed, and the Web of Science from inception to December 2023 to identify studies that examined HR-QoL among patients with scoliosis in China. A list of patient reported outcome measures used in clinical HR-QOL measurement for this population was derived from the selected studies. Stage 2: Reporting followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and AMSTAR (Assessing the methodological quality of systematic reviews) Guidelines. First, we used the COSMIN checklist to assess the methodological quality of studies that reported the measurement properties of the patient reported outcome measures used. Second, the COSMIN tool was used to assess the measurement properties of these instruments, and ratings (excellent, good, fair, or poor) were assigned for each measurement property. Finally, the best evidence was synthesized.

RESULTS

In total, 155 studies were included, and 47 instruments were identified. The top five frequently used HR-QoL instruments for patients with scoliosis in China were the C-SRS-22, ODI, VAS, SF-36, and TC-SRS-22r. The measurement properties assessed included internal consistency (12 instruments), reliability (13 instruments), construct validity (9 instruments), ceiling and floor effects (8 instruments), and responsiveness (3 instruments). The C-ISYQOL had the best methodological quality. No studies assessing measurement properties of instruments for adults with scoliosis were found.

CONCLUSIONS

Based on limited research evidence, the C-ISYQOL currently demonstrates the best measurement performance among HR-QoL assessment instruments for Chinese scoliosis patients. However, due to potential publication bias resulting from the restriction of literature searches to published works (excluding grey literature), as well as minor impacts that strict adherence to COSMIN guidelines may still exert on measurement evaluations due to their inherent limitations, the number of studies supporting the favorable measurement properties of the C-ISYQOL remains insufficient. Therefore, it cannot currently be recommended as the preferred instrument for clinical measurement. Although the C-SRS-22 is widely used and has good reliability and validity for HR-QoL assessment in adolescent patients with scoliosis, its measurement properties have not been adequately evaluated in adult populations, and it is not currently supported for use in HR-QoL assessment of adults with scoliosis. Further studies assessing the measurement properties of these instruments are urgently needed.

摘要

目的

脊柱侧弯是一种脊柱的三维结构畸形,会导致脊柱活动受限、椎旁肌肉无力、心肺功能下降以及慢性身体和心理疼痛。它还会影响患者的生活质量。据统计,截至2022年,中国中小学生脊柱侧弯患者数量已超过500万,并以每年约30万新病例的速度持续增长,而成人脊柱侧弯的发病率更高。因此,评估该人群的健康相关生活质量(HR-QoL)至关重要。本系统评价研究了中国脊柱侧弯患者中HR-QoL结局测量工具的使用频率,并综合了有关其测量特性的证据。

方法

第一阶段:我们检索了包括MEDLINE、EMBASE、Scopus、PubMed和Web of Science在内的数据库,检索时间从数据库建立至2023年12月,以识别在中国脊柱侧弯患者中研究HR-QoL的研究。从所选研究中得出了该人群临床HR-QOL测量中使用的患者报告结局测量列表。第二阶段:报告遵循PRISMA(系统评价和Meta分析的首选报告项目)和AMSTAR(评估系统评价的方法学质量)指南。首先,我们使用COSMIN清单评估报告了所使用的患者报告结局测量的测量特性的研究的方法学质量。其次,使用COSMIN工具评估这些工具的测量特性,并为每个测量特性分配等级(优秀、良好、中等或差)。最后,综合最佳证据。

结果

总共纳入了155项研究,识别出47种工具。在中国脊柱侧弯患者中最常用的前五种HR-QoL工具是C-SRS-22、ODI、VAS、SF-36和TC-SRS-22r。评估的测量特性包括内部一致性(12种工具)、信度(13种工具)、结构效度(9种工具)、天花板效应和地板效应(8种工具)以及反应度(3种工具)。C-ISYQOL具有最佳的方法学质量。未发现评估成人脊柱侧弯工具测量特性的研究。

结论

基于有限的研究证据,目前C-ISYQOL在评估中国脊柱侧弯患者HR-QoL的工具中表现出最佳的测量性能。然而,由于文献检索限于已发表作品(不包括灰色文献)可能导致潜在的发表偏倚,以及严格遵循COSMIN指南因其固有局限性可能对测量评估仍有轻微影响,支持C-ISYQOL良好测量特性的研究数量仍然不足。因此,目前不能推荐将其作为临床测量的首选工具。尽管C-SRS-22被广泛使用,并且在青少年脊柱侧弯患者的HR-QoL评估中具有良好的信度和效度,但其测量特性在成人人群中尚未得到充分评估,目前不支持用于成人脊柱侧弯患者的HR-QoL评估。迫切需要进一步研究评估这些工具的测量特性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df57/12200877/d9b8e7f7bcbd/pone.0325382.g001.jpg

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