Strategies and development of quality assurance and control in the ELSA-Brasil

Strategies and development of quality assurance and control in the ELSA-Brasil
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DOI:
10.1590/s0034-8910.2013047003889
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发表时间:
2013-06-01
影响因子:
2.8
通讯作者:
Nunes, Maria Angelica
Nunes, Maria Angelica
中科院分区:
医学4区
文献类型:
--
作者:
Schmidt, Maria Ines;Griep, Rosane Haerter;Nunes, Maria Angelica

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巴西成人健康纵向研究(ELSA-BRASILL)是一项由15,105名成年人参与的队列研究,目的是评估慢性疾病,特别是糖尿病和心血管疾病的发展。它的规模、多中心性质和测量的多样性需要有效和高效的质量保证和控制机制。主要的质量保证活动(在数据收集之前制定的活动)是:仔细选择研究仪器、集中培训和认证、预先测试和试点研究以及为程序编写操作手册。质量控制活动(在数据收集和处理过程中发展的)在开始时更为密集,当时还没有建立例行程序。主要的质量控制活动是:定期观察技术人员、测试-再测试研究、数据监测、监督员网络和交叉访问。评估所获得信息的可靠性的数据证明质量目标已经实现。
The ELSA-Brasil (Estudo Longitudinal de Saude do Adulto - Brazilian Longitudinal Study for Adult Health) is a cohort study composed of 15,105 adults followed up in order to assess the development of chronic diseases, especially diabetes and cardiovascular disease. Its size, multicenter nature and the diversity of measurements required effective and efficient mechanisms of quality assurance and control. The main quality assurance activities (those developed before data collection) were: careful selection of research instruments, centralized training and certification, pretesting and pilot studies, and preparation of operation manuals for the procedures. Quality control activities (developed during data collection and processing) were performed more intensively at the beginning, when routines had not been established yet. The main quality control activities were: periodic observation of technicians, test-retest studies, data monitoring, network of supervisors, and cross visits. Data that estimate the reliability of the obtained information attest that the quality goals have been achieved.