The Social and Clinical Pharmacy Research Group, Department of Pharmacy, University of Copenhagen, Universitetsparken 2, Copenhagen, Denmark.
Faculty of Pharmaceutical Sciences, University of Iceland, Hagi, Hofsvallagata 53, 107, Reykjavík, Iceland.
Int J Clin Pharm. 2020 Apr;42(2):667-676. doi: 10.1007/s11096-020-00979-5. Epub 2020 Feb 5.
Background Generic and disease specific health-related quality of life scales have been found to be non-responsive to changes in medications in polypharmacy patients. The Taiwanese medication-related quality of life (MRQoL) scale aims to measure the effect of medication use on patients' quality of life. Objective To evaluate the psychometric properties of the Danish translation of MRQoL in a population of patients with polypharmacy. Setting Polypharmacy patients waiting for services at a community pharmacy or hospital in Denmark. Method The original MRQoL included 14 items. It was forward-translated into Danish and backward-translated into Chinese according to a modified translation protocol proposed by Sousa and Rojjanasrirrat et al. The translation was pre-tested, adjusted, and administered to polypharmacy patients. The factor structure was examined using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). Internal consistency reliability was evaluated, and criterion validity assessed using the beliefs about medicines questionnaire (BMQ) and SF-12v2. Known-group validity was carried out on age, number of medicines and setting. Main outcome measure Validity of the Danish version of the MRQoL-scale. Results 164 patients completed the questionnaire. EFA of all 14 items resulted in a two-factor structure, accounting for 72.8% of the total variance. The two factors were named "Energy/Concentration" (7 items) and "Feelings/Social" (7 items). Items correlating over 0.80 were removed leaving 11 items (Model 1). This model was further reduced to 8 items (Model 2) based on Cronbach's alpha. CFA confirmed the two-factor structure of both models. Model 2 fitted data without having to define covariations between error terms. Both factors showed high internal consistency reliability (Cronbachs' alpha 0.901-0.932). Ceiling effects were detected for both factors. Criterion validity was demonstrated via its significant correlations with SF-12vs2 subscales (Spearman's rho 0.340-0.353) and BMQ Concern (Spearman's rho - 0.451 to - 0.347). There was a statistically significant difference in relation to total scores of the MRQoL for age and number of drugs taken, indicating known-group validity. Conclusion The Danish translation of the MRQoL instrument showed measurement properties indicating a well-defined two-factor structure with high internal reliability, concurrent criterion validity, and known group validity. However, challenges remain with ceiling effects and efforts should be put into further development of the instrument.
背景 通用和特定疾病的健康相关生活质量量表已被发现对多种药物治疗的患者的药物变化无反应。台湾药物相关生活质量（MRQoL）量表旨在衡量药物使用对患者生活质量的影响。目的 评估多药治疗患者中 MRQoL 丹麦翻译的心理测量特性。 地点 在丹麦的社区药房或医院等待服务的多药治疗患者。 方法 原始的 MRQoL 包括 14 个项目。根据 Sousa 和 Rojjanasrirrat 等人提出的修改后的翻译方案将其翻译成丹麦语，并翻译成中文。翻译进行了预测试，调整后用于多药治疗患者。使用探索性因子分析（EFA）和验证性因子分析（CFA）检查了因子结构。使用药物信念问卷（BMQ）和 SF-12v2 评估了内部一致性可靠性，并评估了效标效度。进行了年龄，药物数量和设置的已知组有效性。 主要结果措施 丹麦版 MRQoL 量表的有效性。 结果 164 名患者完成了问卷。所有 14 个项目的 EFA 导致了两因素结构，占总方差的 72.8％。这两个因素分别命名为“能量/注意力”（7 项）和“感觉/社交”（7 项）。相关度超过 0.80 的项目被删除，留下 11 个项目（模型 1）。根据 Cronbach 的 alpha，该模型进一步减少到 8 个项目（模型 2）。 CFA 确认了两个模型的两因素结构。模型 2无需定义误差项之间的协变即可拟合数据。两个因素均表现出较高的内部一致性可靠性（Cronbach 的 alpha 为 0.901-0.932）。两个因素均检测到上限效应。通过与 SF-12v2 分量的显着相关性（Spearman 的 rho 0.340-0.353）和 BMQ 关注（Spearman 的 rho-0.451 至-0.347）证明了效标效度。 MRQoL 的总分与年龄和服用药物的数量之间存在统计学上的显着差异，表明存在已知组的有效性。 结论 丹麦语翻译的 MRQoL 工具具有测量性能，表明具有明确的两因素结构，具有较高的内部可靠性，同时具有效标效度和已知组的有效性。但是，上限效应仍然存在，应努力进一步开发该工具。
