Management strategies for implementing a multicenter cross-sectional study: lessons from the ADHERE Brazil study
São Paulo med. j
;
140(3): 439-446, May-June 2022. tab, graf
Artigo
em Inglês
| LILACS
| ID: biblio-1377376
ABSTRACT
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.
Texto completo:
DisponíveL
Índice:
LILACS (Américas)
Assunto principal:
Transplante de Rim
Tipo de estudo:
Ensaio Clínico Controlado
/
Guia de Prática Clínica
/
Estudo observacional
/
Estudo de prevalência
/
Fatores de risco
Limite:
Humanos
País/Região como assunto:
América do Sul
/
Brasil
Idioma:
Inglês
Revista:
São Paulo med. j
Assunto da revista:
Cirurgia Geral
/
Cincia
/
Ginecologia
/
Medicina
/
Medicina Interna
/
Obstetr¡cia
/
Pediatria
/
Sa£de Mental
/
Sa£de P£blica
Ano de publicação:
2022
Tipo de documento:
Artigo
País de afiliação:
Brasil
/
Suíça
Instituição/País de afiliação:
Universidade Federal de Juiz de Fora (UFJF)/BR
/
University of Basel/CH
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