Azimi Parisa, Yazdanian Taravat, Montazeri Ali
Functional Neurosurgery Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
School of Medicine, Capital Medical University, Beijing, China.
Asian Spine J. 2017 Aug;11(4):586-593. doi: 10.4184/asj.2017.11.4.586. Epub 2017 Aug 7.
Prospective clinical study.
To translate and validate the Quality of Life Questionnaire of the European Foundation for Osteoporosis (ECOS-16) in patients with osteoporotic vertebral fractures in Iran.
It is important to assess the psychometric properties of instruments measuring patient-reported outcomes.
The translation was performed using the backward-forward translation method. The final version was generated by consensus among the translators. Every woman who had a T-score of <-2.5 completed ECOS-16. Patients were divided into two study groups according to the World Health Organization's criteria: those with at least one vertebral fracture (surgery group) and those with no fractures (control group). They were asked to respond to the questionnaire at three points in time: preoperative and twice within 1-week interval after surgery assessments (6-month follow-up). The 36-item short-form health survey (SF-36) also was completed. The psychometric properties of the questionnaire were assessed using internal consistency, test-retest reliability, convergent validity, discriminant validity, and responsiveness.
Of 137 recruited women, 39 underwent surgery and 98 did not. Analysis of the ECOS-16 scales showed an appropriate reliability with Cronbach's alpha of >0.70 for all scales. Test-retest reliability as indicated by intraclass correlation coefficient was found to be 0.85 (0.68-0.91). Additionally, the correlation of each item with its hypothesized domain of the ECOS-16 showed acceptable results, suggesting that the items had a substantial relationship with their own domains. Further analysis also indicated that the questionnaire was responsive to change (effect size, 0.85; standardized response mean, 0.93) (<0.001). Significant correlations existed between scores of similar subscales of ECOS-16 and SF-36 (<0.001).
ECOS-16 is an acceptable, reliable, valid, and responsive measure to assess the quality of life in patients with osteoporotic vertebral fractures.
前瞻性临床研究。
对欧洲骨质疏松症基金会生活质量问卷（ECOS - 16）进行翻译并在伊朗骨质疏松性椎体骨折患者中进行验证。
评估测量患者报告结局的工具的心理测量特性很重要。
采用前后翻译法进行翻译。最终版本由翻译人员协商一致产生。每个T值＜ - 2.5的女性完成ECOS - 16问卷。根据世界卫生组织标准将患者分为两个研究组：至少有一处椎体骨折的患者（手术组）和无骨折的患者（对照组）。要求他们在三个时间点回答问卷：术前以及术后评估（6个月随访）的1周间隔内两次。同时完成36项简短健康调查问卷（SF - 36）。使用内部一致性、重测信度、收敛效度、区分效度和反应度来评估问卷的心理测量特性。
在招募的137名女性中，39名接受了手术，98名未接受手术。对ECOS - 16量表的分析表明，所有量表的Cronbach's alpha系数＞0.70，具有适当的信度。组内相关系数显示重测信度为0.85（0.68 - 0.91）。此外，ECOS - 16各项目与其假设领域的相关性显示出可接受的结果，表明这些项目与其自身领域有显著关系。进一步分析还表明问卷对变化有反应（效应量，0.85；标准化反应均值，0.93）（＜0.001）。ECOS - 16和SF - 36相似子量表得分之间存在显著相关性（＜0.001）。
ECOS - 16是一种可接受、可靠、有效且能反映骨质疏松性椎体骨折患者生活质量的测量工具。
