Building research initiative group: chronic illness management and adherence in transplantation (BRIGHT) study: study protocol

Protocol[Abstract] AIM: This article describes the rationale, design and methodology of the Building research initiative group: chronic illness management and adherence in transplantation (BRIGHT) study. This study of heart transplant patients will: (1) describe practice patterns relating to chronic illness management; (2) assess prevalence and variability of non-adherence to the treatment regimen; (3) determine the multi-level factors related to immunosuppressive medication non-adherence. BACKGROUND: The unaltered long-term prognosis after heart transplantation underscores an urgent need to identify and improve factors related to survival outcomes. The healthcare system (e.g. level of chronic illness management implemented) and patient self-management are major drivers of outcome improvement. DESIGN: The study uses a survey design in 40 heart transplant centres covering 11 countries in four continents. METHODS: Theoretical frameworks informed variable selection, which are measured by established and investigator-developed instruments. Heart transplant recipients, outpatient clinicians and programme's directors complete a survey. A staged convenience sampling strategy is implemented in heart transplant centres, countries and continents. Depending on the centre's size, a random sample of 25-60 patients is selected (N estimated 1680 heart transplant recipients). Five randomly selected clinicians and the medical director from each centre will be invited to participate. CONCLUSION: This is the first multi-centre, multi-continental study examining healthcare system and heart transplant centres chronic illness management practice patterns and potential correlates of immunosuppressive medication non-adherence. The knowledge gained will inform clinicians, researchers and healthcare policy makers at which level(s) interventions need to be implemented to improve long-term outcomes for transplant recipient

Describing the evolution of medication nonadherence from pretransplant until 3 years post-transplant and determining pretransplant medication nonadherence as risk factor for post-transplant nonadherence to immunosuppressives : the Swiss Transplant Cohort Study

Although medication nonadherence (MNA) is a major risk factor for poor outcomes, the evolution of MNA from pre- to 3 years post-transplant among the four major organ transplant groups remains unknown. Therefore, this study described this evolution and investigated whether pretransplant MNA predicts post-transplant immunosuppressive medication nonadherence (IMNA). Adult participants (single transplant, pretransplant and ≤1 post-transplant assessment, using medications pretransplant) in the Swiss Transplant Cohort Study (a prospective nation-wide cohort study) were included. Nonadherence, defined as any deviation from dosing schedule, was assessed using two self-report questions pretransplant and at 6, 12, 24 and 36 months post-transplant. Nonadherence patterns were modelled using generalized estimating equations. The sample included 1505 patients (average age: 52.5 years (SD: 13.1); 36.3% females; 924 renal, 274 liver, 181 lung, 126 heart). The magnitude and variability of self-reported MNA decreased significantly from pretransplant to 6 months post-transplant (OR = 0.21; 95% CI: 0.16-0.27). Post-transplant IMNA increased continuously from 6 months to 3 years post-transplant (OR = 2.75; 95% CI: 1.97-3.85). Pretransplant MNA was associated with threefold higher odds of post-transplant IMNA (OR = 3.10; 95% CI: 2.29-4.21). As pretransplant MNA predicted post-transplant IMNA and a continuous increase in post-transplant IMNA was observed, early adherence-supporting interventions are indispensible

Daytime sleepiness in renal transplant recipients is associated with immunosuppressive non-adherence: a cross-sectional, multi-center study

BACKGROUND: The aims of this study were to determine the prevalence of immunosuppressive non-adherence (NA) in renal transplant patients and describe whether the degree of daytime sleepiness (DS) and depressive symptomatology are associated with immunosuppressive NA. METHODS: Using a cross-sectional design, 926 home-dwelling renal transplant recipients who were transplanted at one of three Swiss transplant centers provided data by self-report. The Basel Assessment of Adherence Scale for immunosuppressive was used to measure the following: taking, timing, and overall NA to immunosuppressive medication. DS was assessed with the Epworth Sleepiness Scale (ESS) (cut-off ≥6 for DS) and the Swiss Transplant Cohort Study DS item (cut-off ≥4 for DS), and depressive symptomatology was assessed with the Depression, Anxiety, and Stress Scale (cut-off>10). An ordinal logistical regression model was applied for statistical analysis. RESULTS: The prevalence of the ESS-DS was 51%. NA for taking, timing, and the median overall NA level assessed by 0-100% visual analog scale (VAS) was 16%, 42%, and 0%, respectively. Based on the multivariate analysis, DS was significantly associated (p < 0.001) with taking (1.08 [1.04-1.13]), timing (1.07 [1.03-1.10]), and overall NA (1.09 [1.05-1.13]). Very similar results were found for the Swiss Transplant Cohort Study DS item. CONCLUSION: DS is associated with immunosuppressive medication NA in renal transplant recipients. Admittedly, the association's strength is limited