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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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  • Luana Cristina Lins de Medeiros Oliveira
  • Rand Randall Martins
  • Antonio Gouveia Oliveira

Abstract

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.

Suggested Citation

  • Luana Cristina Lins de Medeiros Oliveira & Rand Randall Martins & Antonio Gouveia Oliveira, 2024. "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," PLOS ONE, Public Library of Science, vol. 19(6), pages 1-15, June.
    • Handle: RePEc:plo:pone00:0305953
    DOI: 10.1371/journal.pone.0305953
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    References listed on IDEAS

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    1. Allison Williams & Jac Kee Low & Elizabeth Manias & Kimberley Crawford, 2016. "The transplant team's support of kidney transplant recipients to take their prescribed medications: a collective responsibility," Journal of Clinical Nursing, John Wiley & Sons, vol. 25(15-16), pages 2251-2261, August.
    2. Elisa Oliveira Marsicano & Neimar Silva Fernandes & Fernando Antônio Basile Colugnati & Natalia Maria Silva Fernandes & Sabina De Geest & Helady Sanders-Pinheiro, 2015. "Multilevel Correlates of Non-Adherence in Kidney Transplant Patients Benefitting from Full Cost Coverage for Immunosuppressives: A Cross-Sectional Study," PLOS ONE, Public Library of Science, vol. 10(11), pages 1-12, November.
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