{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T14:08:05Z","timestamp":1740146885719,"version":"3.37.3"},"reference-count":48,"publisher":"Public Library of Science (PLoS)","issue":"6","license":[{"start":{"date-parts":[[2024,6,25]],"date-time":"2024-06-25T00:00:00Z","timestamp":1719273600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002322","name":"Coordena\u00e7\u00e3o de Aperfei\u00e7oamento de Pessoal de N\u00edvel Superior","doi-asserted-by":"publisher","award":["Finance Code 001"],"award-info":[{"award-number":["Finance Code 001"]}],"id":[{"id":"10.13039\/501100002322","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:p>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\u2019 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.<\/jats:p>","DOI":"10.1371\/journal.pone.0305953","type":"journal-article","created":{"date-parts":[[2024,6,25]],"date-time":"2024-06-25T18:37:55Z","timestamp":1719340675000},"page":"e0305953","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["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"],"prefix":"10.1371","volume":"19","author":[{"given":"Luana Cristina Lins","family":"de Medeiros Oliveira","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rand Randall","family":"Martins","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9103-6532","authenticated-orcid":true,"given":"Antonio Gouveia","family":"Oliveira","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2024,6,25]]},"reference":[{"key":"pone.0305953.ref001","unstructured":"Kidney Disease: Improving Global Outcomes KDIGO CKD Work Group. KDIGO 2012 Clinical practice guideline for the evaluation and management of chronic kidney disease. 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Anthoine","year":"2014","journal-title":"Health Qual Life Outcomes"},{"volume-title":"An Easy Guide to Factor Analysis","year":"1994","author":"Routledge","key":"pone.0305953.ref045"},{"volume-title":"A step-by-step approach to using the SAS system for factor analysis and structural equation modeling","year":"1994","author":"SAS Institute, Inc","key":"pone.0305953.ref046"},{"volume-title":"Making Sense of Factor Analysis: The Use of Factor Analysis for Instrument Development in Health Care Research","year":"2003","author":"SAGE Publications","key":"pone.0305953.ref047"},{"key":"pone.0305953.ref048","doi-asserted-by":"crossref","first-page":"459","DOI":"10.1016\/S0895-4356(99)00206-1","article-title":"Methods for assessing responsiveness: A critical review and recommendations","volume":"53","author":"JA Husted","year":"2000","journal-title":"J Clin Epidemiol"}],"container-title":["PLOS 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