دورية أكاديمية
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.
| العنوان: | 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. |
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| المؤلفون: | de Medeiros Oliveira LCL; 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., Martins RR; Graduate Program in Pharmaceutical Sciences, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte, Natal, RN, Brazil.; Department of Pharmacy, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte, Natal, RN, Brazil., Oliveira AG; Graduate Program in Pharmaceutical Sciences, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte, Natal, RN, Brazil.; Department of Pharmacy, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte, Natal, RN, Brazil. |
| المصدر: | PloS one [PLoS One] 2024 Jun 25; Vol. 19 (6), pp. e0305953. Date of Electronic Publication: 2024 Jun 25 (Print Publication: 2024). |
| نوع المنشور: | Journal Article; Multicenter Study; Validation Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: San Francisco, CA : Public Library of Science |
| مواضيع طبية MeSH: | Kidney Transplantation* , Immunosuppressive Agents*/therapeutic use , Medication Adherence*/statistics & numerical data, Humans ; Surveys and Questionnaires ; Prospective Studies ; Reproducibility of Results ; Graft Rejection/prevention & control ; Pilot Projects ; Female ; Male |
| مستخلص: | 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. Competing Interests: The authors have declared that no competing interests exist (Copyright: © 2024 de Medeiros Oliveira et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.) |
| References: | J Transplant. 2014;2014:675301. (PMID: 24868449) Ther Drug Monit. 2004 Oct;26(5):499-505. (PMID: 15385832) PLoS One. 2015 Nov 30;10(11):e0138869. (PMID: 26619070) J Consult Clin Psychol. 1988 Oct;56(5):754-61. (PMID: 3057010) Front Med (Lausanne). 2022 Feb 18;9:796424. (PMID: 35252242) Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. (PMID: 11124735) Psychol Bull. 1988 Mar;103(2):265-275. (PMID: 3363047) J Investig Med. 2017 Oct;65(7):1049-1056. (PMID: 28483983) Trials. 2017 Oct 16;18(1):480. (PMID: 29037222) Glob J Health Sci. 2014 Apr 16;6(4):205-12. (PMID: 24999131) Radiology. 1982 Apr;143(1):29-36. (PMID: 7063747) Front Public Health. 2018 Jun 11;6:149. (PMID: 29942800) J Adv Nurs. 2017 Jan;73(1):228-239. (PMID: 27532342) Am J Kidney Dis. 2016 Mar;67(3):461-78. (PMID: 26372087) Transplantation. 2014 May 15;97(9):925-33. (PMID: 24445926) Transpl Int. 2013 Oct;26(10):982-9. (PMID: 23879408) N Engl J Med. 2007 Dec 20;357(25):2562-75. (PMID: 18094377) BMJ Open. 2017 Aug 23;7(8):e016813. (PMID: 28838898) Clin Pharmacokinet. 2005;44(8):769-86. (PMID: 16029064) Br J Clin Pharmacol. 2014 Mar;77(3):427-45. (PMID: 23803249) BMC Nephrol. 2017 Mar 29;18(1):107. (PMID: 28356080) J Nephrol. 2016 Oct;29(5):627-36. (PMID: 26885659) Lancet. 2013 Jul 13;382(9887):158-69. (PMID: 23727165) Clin Transplant. 2013 Sep-Oct;27(5):E580-90. (PMID: 24093614) Nephrol Dial Transplant. 2015 May;30(5):752-61. (PMID: 24950938) Clin Transplant. 2016 Jul;30(7):779-86. (PMID: 27101090) J Bras Nefrol. 2017 Jul-Sep;39(3):261-266. (PMID: 29044335) Health Qual Life Outcomes. 2014 Dec 09;12:176. (PMID: 25492701) J Clin Epidemiol. 2000 May;53(5):459-68. (PMID: 10812317) Nefrologia. 2011;31(6):690-6. (PMID: 22130285) J Adv Nurs. 2014 Dec;70(12):2871-83. (PMID: 24853863) Pediatr Transplant. 2015 Aug;19(5):555-62. (PMID: 25917112) BMC Nephrol. 2013 May 21;14:108. (PMID: 23692889) Med Care. 1986 Jan;24(1):67-74. (PMID: 3945130) J Clin Nurs. 2016 Aug;25(15-16):2251-61. (PMID: 27264024) BMJ Open. 2017 Sep 28;7(9):e015411. (PMID: 28963283) |
| المشرفين على المادة: | 0 (Immunosuppressive Agents) |
| تواريخ الأحداث: | Date Created: 20240625 Date Completed: 20240625 Latest Revision: 20240827 |
| رمز التحديث: | 20240828 |
| مُعرف محوري في PubMed: | PMC11198767 |
| DOI: | 10.1371/journal.pone.0305953 |
| PMID: | 38917103 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1932-6203 |
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| DOI: | 10.1371/journal.pone.0305953 |