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

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.

Development and Internal Validation of a Questionnaire Assessing Predisposition to Nonadherence to Immunosuppressive Medication in Kidney Pretransplant Patients.

BACKGROUND: After kidney transplant, nonadherence to immunosuppressive therapy is the main cause of impaired kidney function and graft loss. The objective of this study was the development and internal validation of a clinical questionnaire for assessing the predisposition to adherence to immunosuppressive therapy in kidney pretransplant patients. METHODS: Multicenter prospective study conducted in 7 kidney hemodialysis and 6 kidney transplant centers of 3 Brazilian state capitals. Kidney transplant candidate patients of both sexes and >18-y-old were included. Retransplanted patients were excluded. A 72-item pilot version of the questionnaire, created through literature review complemented with a focus group of 8 kidney pretransplant patients, was administered to 541 kidney transplant candidate patients. Factor analysis with varimax rotation was used for questionnaire development. Internal validity evaluation used Cronbach's alpha and test-retest reliability. Construct validity was assessed by differentiation by known groups. RESULTS: The final questionnaire, named Kidney AlloTransplant Immunosuppressive Therapy Adherence (KATITA) Questionnaire, consisting of 25 items in 3 dimensions, presented good internal consistency reliability (Cronbach's alpha 0.81). The 3 dimensions and respective Cronbach's alpha were "Carelessness" (14 items, 0.81), "Skepticism" (6 items, 0.57), and "Concern" (5 items, 0.62). The interdimension correlation matrix showed low correlation coefficients (<0.35). Test-retest reliability, evaluated with 154 patients, showed an intraclass correlation coefficient of 0.62 (moderate agreement). The scale showed construct validity. CONCLUSIONS: The KATITA-25 questionnaire is the first psychometric instrument for evaluation of predisposition to nonadherence to immunosuppressive medication in candidate patients for kidney transplant in the pretransplant setting.

Comparative study of royal jelly, propolis, and photobiomodulation therapies in 5-fluorouracil-related oral mucositis in rats.

PURPOSE: This study aimed to evaluate the effects and mechanisms of action of royal jelly (RJ) and propolis compared to photobiomodulation therapy (PBMT) in an animal model of 5-fluorouracil-related oral mucositis (OM). METHODS: Seventy-two male Wistar rats were randomly allocated to four groups (n = 18 each): control (no treatment), PBMT (intraoral laser, 6 J/cm2), RJ, and propolis. On days 0 and 2, the animals received an injection of 5-fluorouracil (5-FU). The buccal mucosa was scratched (days 3 and 4) and the treatments were initiated on day 5. Six animals of each group were euthanized on days 8, 10, and 14. Phytochemical analysis (thin-layer chromatography, TLC) and clinical, histopathological, and immunohistochemical analysis of pS6, pAKT, and NF-κB were performed, and oxidative stress markers were also investigated. RESULTS: TLC revealed the presence of large amounts of sucrose (Rf 0.34) in RJ and of flavonoids in propolis. Lower clinical OM scores were observed on day 8, and improved morphological data were observed on day 10 in the PBMT, RJ, and propolis groups (p < 0.05). On day 8, immunoexpression of pS6, pAKT, and NF-κB was increased compared to control. On day 14, reduced glutathione (GSH) antioxidant levels were increased in the propolis group compared to control (p < 0.05). CONCLUSIONS: Our results showed that RJ and propolis, as well as PBMT, are effective in the treatment of OM. Considering that some patients who develop OM do not have access to PBMT, the present study demonstrated that topical application of RJ and propolis may be an important alternative for the treatment of OM.