Elm Jordan J, Kamp Cornelia, Tilley Barbara C, Guimaraes Paulo, Fraser Debbie, Deppen Patricia, Brocht Alicia, Weaver Chris, Bennett Susan
Department of Biostatistics, Bioinformatics and Epidemiology, Medical University of South Carolina, Charleston, South Carolina, USA.
Mov Disord. 2007 Apr 30;22(6):822-7. doi: 10.1002/mds.21409.
To compare the Morisky medication adherence questionnaire to pill counts as measures of adherence in the NET-PD futility clinical trials.
Like in other chronic diseases, non-adherence with medications occurs in Parkinson's disease (PD), although nonadherence has not been of significant concern in most PD clinical trials. The most common approach to assessment is to do a pill count at each visit. The simple, 4-question Morisky medication adherence questionnaire may provide an alternative approach to monitoring treatment adherence in PD.
Adherence data from two NET-PD Phase II clinical trials enrolling a total of 413 participants were analyzed. The association between demographic and clinical characteristics and adherence was explored.
Ninety-percent of participants took 80% or more of the study drug. However, the Morisky medication adherence questionnaires showed 56% report high and 44% report medium adherence. Agreement between the two measures is fair (ICC = 0.40).
Overall adherence as assessed by pill count appears high. The Morisky medication adherence questionnaire may be useful in PD clinical trials, since it is moderately correlated to pill count and may be more sensitive to nonadherence.
在NET-PD无效性临床试验中,比较莫利斯基药物依从性问卷与药片计数作为依从性测量方法的效果。
与其他慢性疾病一样,帕金森病(PD)患者也存在药物不依从的情况,尽管在大多数PD临床试验中,不依从尚未引起重大关注。最常见的评估方法是每次就诊时进行药片计数。简单的4个问题的莫利斯基药物依从性问卷可能为监测PD患者的治疗依从性提供另一种方法。
分析了两项NET-PD II期临床试验的依从性数据,这两项试验共纳入413名参与者。探讨了人口统计学和临床特征与依从性之间的关联。
90%的参与者服用了80%或更多的研究药物。然而,莫利斯基药物依从性问卷显示,56%的人报告高依从性,44%的人报告中等依从性。两种测量方法之间的一致性一般(组内相关系数=0.40)。
通过药片计数评估的总体依从性似乎较高。莫利斯基药物依从性问卷可能在PD临床试验中有用,因为它与药片计数有适度的相关性,并且可能对不依从更敏感。