Tosin Michelle H S, Goetz Christopher G, Bispo Dharah P C F, Ferraz Henrique B, Leite Marco Antonio A, Hall Deborah A, Stebbins Glenn T, Oliveira Beatriz Guitton R B
Department of Nursing, Fluminense Federal University, Niteroi, Brazil.
Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, United States.
Front Aging Neurosci. 2022 May 13;14:900029. doi: 10.3389/fnagi.2022.900029. eCollection 2022.
Medication adherence is a crucial component in the management of patients with chronic diseases needing a long-term pharmacotherapy. Parkinson's disease (PD) is a chronic, degenerative disease with complex drug treatment that poses challenging barriers to patient adherence. The adoption of best practices of scale development can contribute to generate solid concepts and, in the long run, a more stable knowledge base on the underlying constructs of medication adherence in PD measured by the items of the first scale to be created for this purpose.
To present the development process and clinimetric testing plan of the Parkinson's Disease Medication Adherence Scale (PD-MAS).
We adopted a hybrid approach plan based on the United States Food and Drug Administration and Benson and Clark Guide that will create a patient-reported outcome instrument. We presented an overview of consecutive and interrelated steps, containing a concise description of each one. International research centers from Brazil and United States were initially involved in the planning and implementation of the methodological steps of this study.
We developed a four-phase multimethod approach for the conceptualization and the clinimetric testing plan of the PD-MAS. First, we describe the development process of the conceptual framework of the PD-MAS underpinning the scale construct; second, we formalized the development process of the first version of the PD-MAS from the generation of item pools to the content validation and pre-testing; third, we established the steps for the first pilot testing and revision; fourth, we describe the steps plan for the first pilot testing and revision, to finally describe its clinimetric testing plan and validation.
The overview presentation of the development phases and the clinimetric testing plan of the PD-MAS demonstrate the feasibility of creating an instrument to measure the multidimensional and multifactorial components of the medication adherence process in people with PD.
药物依从性是需要长期药物治疗的慢性病患者管理中的关键组成部分。帕金森病(PD)是一种慢性退行性疾病,药物治疗复杂,给患者依从性带来了具有挑战性的障碍。采用量表开发的最佳实践有助于产生坚实的概念,并从长远来看,基于为此目的创建的首个量表项目所测量的PD患者药物依从性的潜在结构,建立一个更稳定的知识库。
介绍帕金森病药物依从性量表(PD-MAS)的开发过程和临床测量测试计划。
我们采用了一种基于美国食品药品监督管理局以及本森和克拉克指南的混合方法计划,以创建一种患者报告结局工具。我们概述了连续且相互关联的步骤,并对每个步骤进行了简要描述。来自巴西和美国的国际研究中心最初参与了本研究方法步骤的规划和实施。
我们为PD-MAS的概念化和临床测量测试计划开发了一种四阶段多方法方法。首先,我们描述了支撑量表结构的PD-MAS概念框架的开发过程;其次,我们将PD-MAS第一版的开发过程形式化,从项目池的生成到内容验证和预测试;第三,我们确定了首次试点测试和修订的步骤;第四,我们描述了首次试点测试和修订的步骤计划,最后描述其临床测量测试计划和验证。
PD-MAS开发阶段和临床测量测试计划的概述展示了创建一种工具来测量PD患者药物依从性过程的多维和多因素组成部分的可行性。