Department of Family Medicine, General Practice and Community Health, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan.
Department of General Medicine, Tsukuba Central Hospital, Ushiku, Japan.
Int J Clin Pharm. 2021 Aug;43(4):858-863. doi: 10.1007/s11096-020-01185-z. Epub 2020 Nov 2.
Background Medication regimen complexity includes various aspects of a regimen, including the dosage form, number of medications and need for additional information for use. Complicated medication regimens cause non-adherence to prescribed medications, making it essential to evaluate medication regimen complexity in older adults to improve adherence to prescribed medications and clinical outcomes. The medication regimen complexity index is currently the most widely used scale for quantifying regimen complexity; however, it has yet to be adopted in Japan. Objective This study aimed to translate the medication regimen complexity index to Japanese and assess its reliability and validity for application in elderly patients in Japan. Setting This study was conducted in a clinic that provides home medical care to patients in the southern part of Ibaraki prefecture, Japan. Method The validation process consisted of translation of the original English version of the medication regimen complexity index to Japanese followed by back-translation to English, comparison of the back-translated and original versions, pilot testing, and assessment of the Japanese version by two raters using the medication regimens of 72 patients with chronic diseases. Main outcome measure The psychometric properties of the index were evaluated according to inter-rater and test-retest reliability, and convergent and discriminant validity. Results The mean age of the 72 patients was 84.3 years. The scale showed high inter-rater reliability (intraclass correlation coefficient 0.946) and test-retest reliability (intraclass correlation coefficient 0.991) for total scores. The number of medications was positively correlated with total medication regimen complexity index score (r = 0.930, P < 0.001). There were no statistically significant differences between age, sex and Charlson Comorbidity Index and medication regimen complexity index score (P > 0.05). Conclusions The Japanese version of the medication regimen complexity index is a reliable and valid tool for assessing the complexity of medication regimen in Japanese elderly patients.
背景 药物治疗方案的复杂性包括方案的各个方面，包括剂型、药物种类和使用所需的额外信息。复杂的药物治疗方案会导致患者不遵医嘱服药，因此评估老年人的药物治疗方案复杂性对于提高患者对医嘱药物的依从性和临床结局至关重要。药物治疗方案复杂性指数是目前用于量化方案复杂性最广泛的量表，但尚未在日本采用。 目的 本研究旨在将药物治疗方案复杂性指数翻译成日语，并评估其在日本老年患者中的可靠性和有效性。 地点 本研究在日本茨城县南部为患者提供家庭医疗护理的诊所进行。 方法 验证过程包括将药物治疗方案复杂性指数的原始英文版本翻译成日语，然后再翻译回英文，比较回译和原文版本，进行预试验，以及由两名评分者使用 72 名慢性病患者的药物治疗方案评估日语版本。 主要结果 该指数的心理测量学特性根据评分者间和重测信度以及收敛和判别效度进行评估。 结果 72 名患者的平均年龄为 84.3 岁。该量表的总分具有较高的评分者间信度（组内相关系数 0.946）和重测信度（组内相关系数 0.991）。药物种类与总药物治疗方案复杂性指数评分呈正相关（r=0.930，P<0.001）。年龄、性别和 Charlson 合并症指数与药物治疗方案复杂性指数评分之间无统计学差异（P>0.05）。 结论 日语版药物治疗方案复杂性指数是评估日本老年患者药物治疗方案复杂性的可靠且有效的工具。
