Study protocol for the development and validation of a questionnaire evaluating predisposition to immunosuppressant medication non-adherence of kidney pre-transplant patients. The KATITA project

• Published in: PloS one 2024-06, Vol.19 (6), p.e0305953
• Main Authors: de Medeiros Oliveira, Luana Cristina Lins, Martins, Rand Randall, Oliveira, Antonio Gouveia
• Format: Article
• Language: English
• Subjects: Chronic illnesses; Diabetes; Drugs; Evaluation; Factor analysis; Female; Graft rejection; Graft Rejection - prevention & control; Hemodialysis; Humans; Immunosuppressive agents; Immunosuppressive Agents - therapeutic use; Kidney diseases; Kidney Transplantation; Kidney transplants; Kidneys; Literature reviews; Male; Medical research; Medication Adherence - statistics & numerical data; Medicine, Experimental; Patient compliance; Patients; Peritoneal dialysis; Pilot Projects; Prospective Studies; Quantitative psychology; Questionnaires; Reproducibility of Results; Surveys; Surveys and Questionnaires; Systematic review; Translation; Transplantation; Triangulation; Validation studies
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0305953

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.