Department of Family Medicine and Primary Care, The University of Hong Kong, 3/F Ap Lei Chau Clinic, 161 Ap Lei Chau Main Street, Ap Lei Chau, Hong Kong.
Division of Endocrine Surgery, Department of Surgery, Queen Mary Hospital, The University of Hong Kong, 102 Pokfulam Road, Pok Fu Lam, Hong Kong.
Patient. 2017 Aug;10(4):447-454. doi: 10.1007/s40271-017-0220-5.
The aim of this study was to examine the acceptability, validity, and reliability of the EuroQoL Five-Dimension Five-Level (EQ-5D-5L) and Short-Form Six-Dimension (SF-6D) health utility measures in patients with symptomatic benign thyroid nodules.
Data from a randomized controlled trial (ClinicalTrials.gov identifier: NCT02398721) of 294 patients with symptomatic benign thyroid nodules were utilized for this psychometric evaluation of health-related quality of life (HR-QOL) measurement. Three HR-QOL questionnaires-the generic 12-item Short Form Health Survey (SF-12v2), EQ-5D-5L, and SF-6D-were interviewer-administered at baseline and 2 weeks afterwards. Responses to SF-6D were transformed to SF-6D utility scores using a Hong Kong population scoring algorithm derived by standard gamble, whereas responses to EQ-5D-5L were mapped onto EQ-5D-3L response via interim mapping algorithms and then converted to EQ-5D-5L utility scores using a Chinese-specific value set. Construct validity was determined by evaluating Spearman correlation between SF-12v2 scores and utility scores. Two-week test-retest reliability was assessed using intra-class correlation coefficient.
No significant (>15%) floor and ceiling effects were observed for SF-6D utility scores. The SF-6D utility scores had a moderate Spearman rank correlation with the SF-12v2 domain score providing evidence for adequate construct validity. The SF-6D utility scores showed good test-retest reliability (0.794; range 0.696-0.860). Better reliability was observed in SF-6D utility scores than in EQ-5D-5L utility scores.
While the EQ-5D-5L instrument was less reproducible, the SF-6D instrument appeared to be an applicable, valid, and reliable measure in assessing the HR-QOL of Chinese patients with symptomatic benign thyroid nodules. The impact of utility score selection on the effectiveness and cost effectiveness of clinical interventions targeted to these patients needs further exploration.
NCT02398721, ClinicalTrials.gov.
本研究旨在检验 EuroQoL 五维五水平(EQ-5D-5L)和简短六维度(SF-6D)健康效用测量在有症状良性甲状腺结节患者中的可接受性、有效性和可靠性。
本研究利用一项有症状良性甲状腺结节随机对照试验(ClinicalTrials.gov 标识符:NCT02398721)的数据,对 294 例有症状良性甲状腺结节患者的健康相关生活质量(HR-QOL)测量进行了心理计量学评估。在基线和 2 周后,使用三个 HR-QOL 问卷——通用 12 项简式健康调查(SF-12v2)、EQ-5D-5L 和 SF-6D——对患者进行了访谈式调查。使用香港人群标准博弈衍生的评分算法,将 SF-6D 的应答转换为 SF-6D 效用得分,而 EQ-5D-5L 的应答则通过中间映射算法映射到 EQ-5D-3L 的应答,然后使用中国特有的价值集将其转换为 EQ-5D-5L 效用得分。通过评估 SF-12v2 评分与效用评分之间的斯皮尔曼相关关系,确定结构有效性。使用组内相关系数评估两周的重测信度。
SF-6D 效用得分未出现显著的(>15%)地板效应和天花板效应。SF-6D 效用得分与 SF-12v2 领域评分具有中度斯皮尔曼等级相关,这表明结构有效性充分。SF-6D 效用得分具有良好的重测信度(0.794;范围 0.696-0.860)。SF-6D 效用得分的可靠性优于 EQ-5D-5L 效用得分。
虽然 EQ-5D-5L 仪器的再现性较差,但 SF-6D 仪器似乎是评估中国有症状良性甲状腺结节患者 HR-QOL 的一种适用、有效且可靠的测量方法。效用得分选择对针对这些患者的临床干预的有效性和成本效益的影响需要进一步探讨。
NCT02398721,ClinicalTrials.gov。