肾移植候选患者免疫抑制剂治疗依从性差：KATITA-25 量表的外部验证。

Nonadherence to Immunosuppressant Therapy of Kidney Transplant Candidate Patients: External Validation of the KATITA-25 Scale.

机构信息

Graduate Program in Pharmaceutical Sciences, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte, Natal-RN, Brazil.

Clinical Pharmacy Unit, Onofre Lopes University Hospital, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte, Natal-RN, Brazil.

出版信息

Transplantation. 2024 Aug 1;108(8):1812-1820. doi: 10.1097/TP.0000000000004994. Epub 2024 Mar 29.

DOI:10.1097/TP.0000000000004994

PMID:38548683

Abstract

BACKGROUND

The self-administered Kidney AlloTransplant Immunosuppressive Therapy Adherence (KATITA-25) questionnaire is a multidimensional scale for use in the pretransplant setting that evaluates the predisposition to nonadherence of patients who are candidates to kidney transplant. The scale has shown adequate internal consistency and test-retest reliability. This study presents the results of an external validation study of the KATITA-25 scale.

METHODS

Patients >18 y old scheduled for kidney transplant were included in this multicenter study. The KATITA-25 scale was administered before surgery and then at 3-mo posttransplantation for evaluation of scale sensitivity to change. At this time, 2 validated medication adherence scales were applied for assessment of concurrent validity. For evaluation of predictive validity, nonadherence to immunosuppressive medication was assessed at 6 and 12 mo after transplantation by 3 independent methods: patient self-report of nonadherence using the Morisky-Green-Levine Medication Assessment Questionnaire scale, serum trough levels of immunosuppressants, and pharmacy refills.

RESULTS

Three twenty-two patients were available for evaluation of concurrent validity and 311 patients of predictive validity. After kidney transplant, the median KATITA-25 score decreased from 20 to 8 ( P < 0.001), demonstrating scale sensitivity to change, and the KATITA-25 score showed correlation with the Basel Assessment of Adherence to Immunosuppressive Medication Scale score (Spearman's ρ 0.18, P = 0.002) and the Cuestionario para la Evaluación de la Adhesión al Tratamiento Antiretroviral scores (ρ -0.17, P = 0.002), confirming concurrent validity. The nonadherence rate was 57.6%. The scale predictive validity was demonstrated by the area under the receiver operating characteristics curve (0.68), sensitivity (59.8%), specificity (68.2%), and positive predictive value (71.8%).

CONCLUSIONS

This external validation study of KATITA-25 scale provided evidence of sensitivity to change, and structural, criterion, and predictive validity.

摘要

背景

自我管理的肾移植免疫抑制治疗依从性（KATITA-25）问卷是一种多维量表，用于评估候选肾移植患者的非依从性倾向。该量表已显示出足够的内部一致性和重测信度。本研究报告了 KATITA-25 量表的外部验证研究结果。

方法

纳入了年龄大于 18 岁、计划接受肾移植的患者。在手术前和移植后 3 个月进行 KATITA-25 量表评估，以评估量表对变化的敏感性。此时，应用了 2 种经过验证的药物依从性量表来评估同时效度。为了评估预测效度，在移植后 6 个月和 12 个月，通过 3 种独立方法评估免疫抑制药物的不依从性：患者使用 Morisky-Green-Levine 药物评估问卷自评、免疫抑制剂的血清谷浓度和药物补充。

结果

322 例患者可用于评估同时效度，311 例患者可用于评估预测效度。肾移植后，KATITA-25 评分中位数从 20 降至 8（P<0.001），表明量表对变化敏感，KATITA-25 评分与巴塞尔免疫抑制药物依从性评估量表评分（Spearman ρ 0.18，P=0.002）和抗逆转录病毒治疗依从性评估问卷评分（ρ-0.17，P=0.002）相关，确认了同时效度。不依从率为 57.6%。该量表的预测效度通过受试者工作特征曲线下面积（0.68）、灵敏度（59.8%）、特异性（68.2%）和阳性预测值（71.8%）得到证实。