PDF(Pubmed)
Abstract：
Non-adherence to immunosuppressive medication after kidney transplant is an important cause of graft rejection and loss. Approaches to minimization of non-adherence have focused on the identification of episodes of medication non-adherence, but by then irreparable harm to the graft may already have occurred, and a more effective approach would be to adopt preventive measures in patients who may have difficulty in adhering to medication. The aim of this study protocol is to develop and validate a clinical questionnaire for assessing, in kidney transplant candidate patients in the pre-transplant setting, the predisposition to non-adherence to immunosuppressive medication. In this multicenter, prospective study, a pilot questionnaire in Brazilian Portuguese language, composed of Likert-scaled statements expressing patients\' beliefs, behaviors and barriers regarding medication taking will be assembled from a literature review, from focus groups, and an expert panel. The pilot questionnaire will be administered to a minimum of 300 patients in kidney transplant waiting lists and exploratory factor analysis will be used for development of the definitive questionnaire. A random subsample of a minimum of 60 patients will have the scale re-administered after one month for evaluation of test-retest reliability. A multicenter, external validation study will include 364 kidney transplant candidates who will be evaluated immediately before surgery and at months 3, 6 and 12 post-transplant for assessment of concurrent validity, by comparison with two scales that assess medication non-adherence, and for determination of predictive validity using a triangulation method for assessment of medication non-adherence. Structural validity will be assessed with confirmatory factor analysis using structural equation modeling. Cross-cultural generalizability and validity will be assessed by a multicenter study, in which a translation of the scale to another language will be administered to kidney transplant candidate patients from a different culture, with a subsample being selected for test-retest. This study will be conducted in Spain with a Spanish translation of the scale.
摘要：
肾移植后不坚持免疫抑制药物是移植物排斥和丢失的重要原因。最小化不依从性的方法集中在识别药物不依从性的发作。但是到那时，对移植物的无法弥补的伤害可能已经发生了，更有效的方法是对可能难以坚持药物治疗的患者采取预防措施。本研究方案的目的是开发和验证用于评估的临床问卷，在移植前的肾移植候选患者中，不坚持免疫抑制药物的倾向。在这个多中心，前瞻性研究，一份巴西葡萄牙语的试点问卷，由Likert缩放的陈述组成，表达患者的信念，关于服药的行为和障碍将从文献综述中收集，来自焦点小组，和一个专家小组。试点问卷将在肾移植等待名单中对至少300名患者进行管理，探索性因素分析将用于制定最终问卷。至少60名患者的随机子样本将在一个月后重新施用量表，以评估测试-重测可靠性。一个多中心，外部验证研究将包括364名肾移植候选人，他们将在手术前和移植后3、6和12个月进行评估，以评估并发有效性，通过与两个评估药物不依从性的量表进行比较，并使用三角法评估药物不依从性来确定预测有效性。将使用结构方程模型通过验证性因子分析评估结构有效性。跨文化的普遍性和有效性将通过多中心研究进行评估，其中将对来自不同文化的肾移植候选患者进行量表到另一种语言的翻译，选择一个子样本进行重测。这项研究将在西班牙进行与规模的西班牙语翻译。
