Improved performance after implementation of a quality assurance program in a multisite perinatal HIV research initiative in Southern Brazil
ISSUES: Quality assurance is an important part of a research protocol. Poor quality can compromise research results and lead to unrealistic findings. Objectives are to describe the preparation and implementation of a Quality Assurance Program (QAP) in a multicenter research initiative and to evaluate site performance. DESCRIPTION: University of Caxias do Sul (UCS) is participating in an international Perinatal HIV research initiative coordinating a consortium of four sites in two different cities, 83 miles apart, where most staff never participated in a long term observational study. Sites were invited to present a list of problems and suggestion for the QAP. Site evaluation was based on monthly site performance report (MSPR) provided by the sponsor. MSPR is based on the data received from sites and processed by the US based data center. Acceptable site performance parameter is data retrieval (DR) < 5%. DR is calculated on mistakes: e.g.; missing data, date problems and inconsistencies. We compared overall consortium MSPR results from the three previous months (P1) of implementation with the three subsequent months of implementation (P2). LESSONS LEARNED: QAP preparation took 20 days. Forms, flowcharts, roles and procedures were developed based on the experience of administrative and sites staff. Implementation is ongoing and reflects a learning period of 7 months. Common mistakes prior to QAP implementation were related to completion of forms and inconsistencies with patient past history. QAP implementation resulted in a significant reduction in DR (P1: 15.56%; P2: 3.24%; (p<0.05) and its success was due to the adaptation of specific site organizational structure and staff involvement. RECOMMENDATION: QAP is important to assure quality data and should be introduced to the research team before protocol implementation. Also it's important to enforce the message that QAP is not made to police performance but develop research skills and appropriate organizational infrastructure. Continuous monitoring will be conducted to assure QAP compliance.
De Souza, C T
C T De Souza, R S De Souza, L R Motta, M C Bisi, M Cavagnoli, A L A Aver, P B Pasquali, M Bertelli
HIV/AIDS Research Laboratory - Universidade de Caxias do Sul, Caxias do Sul, Brazil