Gerencia de Informacao em Estudos Multicentricos: o Estudo Longitudinal de Saude do Adulto

Abstract

Information management in large multicenter studies requires a specialized approach. The Estudo Longitudinal da Saúde do Adulto (ELSA-BrasilBrazilian Longitudinal Study for Adult Health) has created a Datacenter to enter and manage its data system. The aim of this paper is to describe the steps involved, including the information entry, transmission and management methods. A web system was developed in order to allow, in a safe and confi dential way, online data entry, checking and editing, as well as the incorporation of data collected on paper. Additionally, a Picture Archiving and Communication System was implemented and customized for echocardiography and retinography. It stores the images received from the Investigation Centers and makes them available at the Reading Centers. Finally, data extraction and cleaning processes were developed to create databases in formats that enable analyses in multiple statistical packages. In 2001, Guimarães et al 7 described that some areas of scientific activity in epidemiology, like that of chronic non-communicable diseases, were still not well developed in Brazil. In the last decade, as a result of a substantial increase in the promotion of health research, these diseases have begun to be better investigated. The comprehensiveness of the collected information has been expanded and the methodology for its acquisition has become more complex. DESCRIPTORS: Multicenter Studies as

Estrategias e desenvolvimento de garantia e controle de qualidade no ELSA-Brasil

“…3 Periodic reports were produced to meet the study's recruitment goals ,and reports on the data incorporated into the system were also generated, in order to evaluate the completeness of the activities performed and to request clarifi cation of inconsistencies.…”

Construcao do Estudo Longitudinal de Saude do Adulto (ELSA-Brasil)

“…12 The project is managed collectively and its governing body is the Research Steering Committee aided by assisting committees and an External Advisory Committee. The study activities take place at local site facilities in especially designated areas.…”

“…The central laboratory 13 and biobank 17 are hosted at the São Paulo site and the Data Center at the Rio Grande do Sul site. 12 The study sites developed standard procedures for performing complex assessment as well as provided training and certifi cation of their staff in testing and result reading. 6,10,15 The results of medical assessments and measurements including electrocardiograms, 18 echocardiography, retinography, pulse wave velocity, and abdominal and vascular ultrasound are coded and data is transferred to the ELSA-Brasil reading centers.…”

Estratégias de identificação, investigação e classificação de desfechos incidentes no ELSA-Brasil

“…Contact information of subjects and their informants are accessed online and consistently updated directly into ELSA-Brasil data entry system. 7 Annual follow-up interview questionnaires were also made available for online data entry and can be completed in real time while interviewing subjects or data can be entered later when completion is manual. The system facilitates the interview process by showing warnings when the interviewer is required to complete additional forms.…”