Lee Seong Min, Kim Soo-Jin, Nam Dongwoo, Park Yeon Cheol, Kim Eun-Jung, Ha In-Hyuk, Lee Yoon Jae
Jaseng Hospital of Korean Medicine, Gangnam-gu, Republic of Korea.
Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Gangnam-gu, Republic of Korea.
BMJ Open. 2024 Dec 26;14(12):e086104. doi: 10.1136/bmjopen-2024-086104.
This study aimed to identify a preference-based health-related quality of life (HRQOL) measure that best reflects disease-specific features in patients with neck pain by comparing the characteristics of the instruments.
Pooled data from three multicentre randomised controlled clinical trials (RCTs) on neck pain were included for analysis in this study.
All three RCTs were conducted between 2017 and 2020 in Korea, and patients were recruited from four hospitals and one university teaching hospital.
In total, 313 patients with neck pain were included in the three RCTs.
A correlation analysis was conducted using Spearman's correlation coefficients between preference-based HRQOL scores (EuroQol-5 Dimension 5 Levels (EQ-5D-5L) and Short-Form 6-Dimension version 1 (SF-6Dv1)) and the disease-specific measures for pain and function (Numerical Rating Scale (NRS), Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Northwick Park Questionnaire).
Spearman's correlation analyses (p value <0.01 for all) showed that EQ-5D-5L exhibited slightly stronger negative correlations with pain-related measures (VAS: -0.277, NRS: -0.262) compared with SF-6Dv1 (VAS: -0.207, NRS: -0.182). For functional outcomes, EQ-5D-5L demonstrated stronger negative correlations with function-related measures such as NDI (-0.636 to -0.711) compared with SF-6Dv1 (-0.506 to -0.579). In patients with moderate-to-severe neck pain (VAS>5), EQ-5D-5L appeared to better capture functional and pain aspects. Despite these differences, both instruments consistently reflected treatment-related improvements in pain and function. Distribution analysis further indicated that EQ-5D-5L and SF-6Dv1 were not fully interchangeable due to variations in domain-level scoring patterns and ceiling effects observed in EQ-5D-5L.
EQ-5D-5L showed stronger negative correlations with both pain and functional outcomes compared with SF-6Dv1, suggesting that it may better capture the functional aspects of chronic neck pain, particularly in moderate-to-severe conditions. However, the ceiling effect observed in EQ-5D-5L warrants caution when interpreting results in patients with mild neck pain. These findings provide practical guidance for selecting preference-based HRQOL measures in economic evaluations of musculoskeletal conditions, supporting more informed healthcare decision-making.Trial registration numberNCT03294785, Post-results; NCT03558178, Results; NCT04035018, Post-results.
本研究旨在通过比较各种工具的特征，确定一种基于偏好的健康相关生活质量（HRQOL）测量方法，该方法能最好地反映颈部疼痛患者的疾病特异性特征。
本研究纳入了三项关于颈部疼痛的多中心随机对照临床试验（RCT）的汇总数据进行分析。
所有三项RCT均于2017年至2020年在韩国进行，患者从四家医院和一家大学教学医院招募。
三项RCT共纳入313例颈部疼痛患者。
使用基于偏好的HRQOL评分（欧洲五维度五水平量表（EQ-5D-5L）和简短六维度1版（SF-6Dv1））与疼痛和功能的疾病特异性测量指标（数字评分量表（NRS）、视觉模拟量表（VAS）、颈部残疾指数（NDI）和诺斯威克公园问卷）之间的斯皮尔曼相关系数进行相关分析。
斯皮尔曼相关分析（所有p值均<0.01）表明，与SF-6Dv1（VAS：-0.207，NRS：-0.182）相比，EQ-5D-5L与疼痛相关测量指标（VAS：-0.277，NRS：-0.262）的负相关性略强。对于功能结局，与SF-6Dv1（-0.506至-0.579）相比，EQ-5D-5L与功能相关测量指标如NDI（-0.636至-0.711）的负相关性更强。在中度至重度颈部疼痛（VAS>5）患者中，EQ-5D-5L似乎能更好地反映功能和疼痛方面。尽管存在这些差异，但两种工具都一致反映了疼痛和功能方面与治疗相关的改善。分布分析进一步表明，由于EQ-5D-5L中观察到的领域水平评分模式差异和天花板效应，EQ-5D-5L和SF-6Dv1并非完全可互换。
与SF-6Dv1相比，EQ-5D-5L与疼痛和功能结局的负相关性更强，表明它可能能更好地反映慢性颈部疼痛的功能方面，特别是在中度至重度情况下。然而，在解释轻度颈部疼痛患者的结果时，EQ-5D-5L中观察到的天花板效应值得谨慎。这些发现为在肌肉骨骼疾病的经济评估中选择基于偏好的HRQOL测量方法提供了实际指导，支持更明智的医疗保健决策。试验注册号NCT03294785，结果公布后；NCT03558178，结果；NCT04035018，结果公布后。
