University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
J Eval Clin Pract. 2012 Jun;18(3):515-22. doi: 10.1111/j.1365-2753.2011.01636.x. Epub 2011 Feb 14.
Several factors contribute to the complexity of pharmacotherapeutic regimens, like the total number of medications to be taken, the number of dosage units to take at a time, dosage frequency, as well as specific directions concerning the administration. The Medication Regimen Complexity Index (MRCI) is a validated instrument developed in English for the measurement of the complexity of a given pharmacotherapeutic regimen.
Translation of the MRCI into German and evaluation of the translated instrument (MRCI-D) in order to make it more easily accessible for use in German practice and research.
The process of validation included the translation of the English version to German, back-translation into English, comparison of the back-translated and the original versions, pre-tests, and pilot-testing of the German version by three raters using 20 medication regimens for inpatients. The subsequent psychometric evaluation included the calculation of inter-rater and test-retest reliability, as well as the assessment of convergent validity.
The number of medications correlated highly and statistically significantly with the MRCI-D score (0.91, P < 0.001), indicating sufficient convergent validity of the instrument. Both inter-rater and test-retest reliability were very high (intraclass correlation coefficients above 0.80 in all cases).
Our results demonstrate that the German version of the MRCI reflects the complexity of therapeutic regimens with similar validity and reliability as the established English version. Thus, it may be a valuable tool to analyse therapeutic regimens in both clinical practice and science.
多种因素导致药物治疗方案的复杂性，例如需要服用的药物总数、每次服用的剂量单位数、剂量频率，以及关于给药的具体说明。药物治疗方案复杂性指数（MRCI）是一种在英语中开发的经过验证的工具，用于测量特定药物治疗方案的复杂性。
将 MRCI 翻译成德语并评估翻译后的工具（MRCI-D），以便在德国实践和研究中更方便地使用。
验证过程包括将英文版翻译成德语、回译回英语、比较回译版和原始版、预测试以及三位评估员使用 20 种住院患者的药物治疗方案对德语版进行的试点测试。随后的心理测量评估包括计算评估者间和测试-重测信度，以及评估收敛效度。
药物数量与 MRCI-D 评分高度相关且具有统计学意义（0.91，P < 0.001），表明该工具具有足够的收敛效度。评估者间和测试-重测信度都非常高（所有情况下的组内相关系数均高于 0.80）。
我们的结果表明，MRCI 的德语版本反映了治疗方案的复杂性，与既定的英语版本具有相似的有效性和可靠性。因此，它可能是分析临床实践和科学中治疗方案的有价值的工具。
