Methods Employed in Monitoring and Evaluating Field and Laboratory Systems in the ANISA Study: Ensuring Quality

The Aetiology of Neonatal Infection in South Asia (ANISA) study maintains operations in Bangladesh, India and Pakistan. We developed and deployed a multilayered monitoring system to measure performance indicators of field sites and laboratory operations. This system allows for real-time provision of...

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Published in:The Pediatric infectious disease journal Vol. 35; no. 5 Suppl 1; pp. S39 - S44
Main Authors: Connor, Nicholas E, Islam, Mohammad Shahidul, Arvay, Melissa L, Baqui, Abdullah H, Zaidi, Anita K, Soofi, Sajid B, Panigrahi, Pinaki, Bose, Anuradha, Islam, Maksuda, El Arifeen, Shams, Saha, Samir K, Qazi, Shamim A
Format: Journal Article
Language:English
Published: United States 01.05.2016
Subjects:
Bangladesh - epidemiology
Clinical Laboratory Techniques - standards
Data Collection
Diagnostic Tests, Routine - standards
Epidemiological Monitoring
Humans
Incidence
India - epidemiology
Infant
Infant, Newborn
Neonatal Sepsis - epidemiology
Neonatal Sepsis - etiology
Pakistan - epidemiology
Pilot Projects
Risk Factors
Specimen Handling - standards
ISSN:1532-0987
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Summary:The Aetiology of Neonatal Infection in South Asia (ANISA) study maintains operations in Bangladesh, India and Pakistan. We developed and deployed a multilayered monitoring system to measure performance indicators of field sites and laboratory operations. This system allows for real-time provision of feedback to study site teams and project stakeholders. The goal of this monitoring and evaluation system is to promote optimal performance and consistency in protocol application at all sites over the course of the study, thereby safeguarding the validity of project findings. This article describes each of the interdependent monitoring layers that were conceptualized, developed and employed by the ANISA coordination team. Layers of monitoring include site-level, central and database-related activities along with periodic site visitation. We provide a number of real-world examples of how feedback from the ANISA monitoring system directly informs a number of crucial decisions and course corrections during the project. The ANISA monitoring system represents a transparent, understandable and practical resource for development of project monitoring systems in complex multisite health research projects.
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ISSN:1532-0987
DOI:10.1097/INF.0000000000001105