Management strategies for implementing a multicenter cross-sectional study: lessons from the ADHERE Brazil study

ABSTRACT BACKGROUND: Epidemiological studies involving large samples usually face financial and operational challenges. OBJECTIVES: To describe the planning and execution of ADHERE Brazil, an epidemiological study on 1,105 kidney transplant patients, and report on how the study was structured, difficulties faced and solutions found. DESIGN AND SETTING: Cross-sectional multicenter study in 20 Brazilian kidney transplantation centers. METHODS: Actions developed in each phase of implementation were described, with emphasis on innovations used within the logistics of this study, aimed at estimating the prevalence of nonadherence to treatment. RESULTS: Coordination of activities was divided into four areas: general, regulatory, data collection and statistics. Weekly meetings were held for action planning. The general coordination team was in charge of project elaboration, choice of participating centers, definition of publication policy and monitoring other coordination teams. The regulatory team provided support to centers for submitting the project to ethics committees. The data collection team prepared a manual on the electronic collection system, scheduled web meetings and was available to respond to queries. It also monitored the data quality and reported any inadequacies found. Communication with the centers was through monthly reports via e-mail and distribution of exclusive material. The statistical team acted in all phases of the study, especially in creating the data analysis plan and data bank, generation of randomization lists and data extraction. CONCLUSIONS: Through these logistics, we collected high-quality data and built a local research infrastructure for further studies. We present supporting alternatives for conducting similar studies. CLINICAL TRIAL ANNOTATION: http://clinicaltrials.gov/ on October 10, 2013; NCT02066935.

Nonadherence to immunosuppressives and treatment in kidney transplant: Adhere Brazil Study

ABSTRACT OBJECTIVE To estimate the prevalence and variability of nonadherence to immunosuppressives and nonpharmacological treatment across kidney transplantation centers and two health access-disparate regions in Brazil. METHODS In a cross-sectional design, a random multistage sample of 1,105 patients was included, based on center transplantation activity (low/moderate/high) and region (R1: North/Northeast/Mid-West; and R2: South/Southeast). Nonadherence to immunosuppressives (implementation phase) was assessed using the Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS)©. Self-report questionnaires assessed nonadherence to physical activity, smoking cessation, alcohol intake, and appointment keeping. We compared regions using the adjusted-χ2 or t-test. RESULTS Most patients were men (58.5%), white (51.4%), and had a mean age of 47.5 (SD = 12.6) years. Regarding kidney transplantation centers, 75.9% were from R2 and 38.2% had low activity. The patients in R2 were older, white-majority, had more frequently steady partners, and received peritoneal dialysis. Nonadherence to immunosuppressives ranged from 11-65.2%; 44.5-90% to physical activity; 0-23.7% to appointment keeping; and 0-14% to smoking cessation. The total prevalence of nonadherence and by region (R1 versus R2) were: for immunosuppressives, 39.7% (44.9% versus 38.1%, p = 0.18); for smoking, 3.9% (1% versus 5%, p < 0.001); for physical activity, 69.1% (71% versus 69%, p = 0.48); for appointment keeping, 13% (12.7% versus 12%, p = 0.77); and for alcohol consumption, 0%. CONCLUSION Despite differences among centers and high variability, only the nonadherence to smoking cessation was higher in the region with greater access to kidney transplantation. We suppose that differences in healthcare access may have been overcome by other positive aspects of the post kidney transplantation treatment.