Pharmacotherapy assessment in chronic kidney disease: validation of the PAIR instrument for use in Brazil

Abstract Individuals with chronic kidney disease (CKD) use polypharmacy, which, in combination with renal impairment, exposes them to the risk of drug-related problems (DRPs). There are no available tools in Brazil to systematically assess the pharmacotherapy and management of DRPs in this population. Therefore, the objective of this work was to validate the PAIR instrument (Pharmacotherapy Assessment in Chronic Renal Disease) for use in Brazilian Portuguese. This is a retrospective longitudinal observational study. Medical records from 100 CKD patients under conservative treatment, between 2016 and 2017, in a nephrology clinic, were analyzed. PAIR was applied by pharmacists in two consultations of the same patient, with an interval of 6 months. Reliability, conceptual validity, responsiveness of the instrument and prevalence of DRPs in the studied sample were assessed. A mean of 1.26 ± 0.96 DRPs/patient was identified. Inter-rater reliability coefficients (k) ranged from 0.58 to 0.94 and from 0.79 to 1.00 for test-retest, revealing moderate to perfect level of agreement. In conceptual validity, a mean of 1.60 ± 1.24 DRPs/patient was identified by the nephrologist through clinical judgment, compared to 1.33±0.76 DRPs/patient identified by the pharmacist using PAIR (p = 0.07). Therefore PAIR allowed the identification of clinically significant DRPs. In responsiveness, a mean of 1.26 ± 0.96 DRPs/patient was identified at the first consultation and 1.11 ± 1.02 DRPs/patient at the subsequent consultation (p = 0.17) by the pharmacist using PAIR. The number of DRPs between the periods did not change. As a conclusion, the PAIR allowed the identification of clinically significant DRPs in CKD, constituting a new validated instrument to be used in Brazil.

慢性肾脏病（chronic kidney disease, CKD）患者常接受多重用药，加之肾功能受损，使其面临药物相关问题（drug-related problems, DRPs）风险。目前巴西尚无用于系统评估该人群药物治疗与DRPs管理的专用工具。故此本研究旨在针对巴西葡萄牙语使用者，验证PAIR工具（慢性肾脏病药物治疗评估工具，Pharmacotherapy Assessment in Chronic Renal Disease）的适用性。本研究为回顾性纵向观察性研究，分析了2016至2017年间某肾病专科门诊100例接受保守治疗的CKD患者的病历资料。由药师在同一患者的两次间隔6个月的随访咨询中，应用PAIR工具开展评估。本研究对该工具的评定者间信度、构想效度、响应性以及研究样本中DRPs的患病率进行了评估。研究共检出每名患者平均1.26±0.96个DRPs。评定者间信度系数（Kappa值，k）范围为0.58~0.94，重测信度系数范围为0.79~1.00，提示一致性水平从中度至近乎完美。在构想效度方面，肾病医师通过临床判断检出每名患者平均1.60±1.24个DRPs，而药师使用PAIR工具检出的DRPs数量为每名患者1.33±0.76个（p=0.07），证实PAIR工具可识别具有临床意义的DRPs。在响应性方面，药师使用PAIR工具在首次随访咨询中检出每名患者平均1.26±0.96个DRPs，在后续随访咨询中检出1.11±1.02个DRPs（p=0.17），两阶段检出的DRPs数量无显著统计学差异。综上，PAIR工具可在CKD患者群体中识别具有临床意义的DRPs，是一款可在巴西推广应用的新型验证工具。