The Monitoring and Evaluation of a Multicountry Surveillance Study, the Severe Typhoid Fever in Africa Program

• Type of Material: Article
• Authors: Ondari D Mogeni, International Vaccine Institute; Ligia Maria Cruz Espinoza, International Vaccine Institute; Justin Im, International Vaccine Institute; Ursula Panzner, International Vaccine Institute; Trevor Toy, International Vaccine Institute; Gi Deok Pak, International Vaccine Institute; Andrea Haselbeck, International Vaccine Institute; Enusa Ramani, International Vaccine Institute; Heidi Schuett-Gerowitt, University of Cologne; Jan Jacobs, Institute of Tropical Medicine; Octavie Lunguya Metila, Cliniques Universitaires de Kinshasa; Oluwafemi J Adewusi, University of Ibadan; Iruka N Okeke, University of Ibadan; Veronica I Ogunleye, University of Ibadan; Ellis Owusu-Dabo, Kwame Nkrumah University Science & Technology; Raphael Rakotozandrindrainy, University of Antananarivo; Abdramane Bassiahi Soura, University of Ouagadougou; Mekonnen Teferi, Armauer Hansen Research Institute; Keriann Conway Roy, Emory University; William Macwright, Emory University; Robert F Breiman, Emory University; Jerome H Kim, International Vaccine Institute; Vittal Mogasale, International Vaccine Institute; Stephen Baker, University of Cambridge; Se Eun Park, International Vaccine Institute; Florian Marks, International Vaccine Institute
• Language: English
• Date: 2019-11-15
• Publisher: Oxford University Press (OUP): Policy B - Oxford Open Option C
• Publication Version: Final Published Version
• Copyright Statement: © 2019 The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1093/cid/ciz597
• Title of Journal or Parent Work: Clinical Infectious Diseases
• ISSN: 1058-4838
• Volume: 69
• Issue: Supplement_6
• Start Page: S510
• End Page: S518
• Grant/Funding Information: This research was funded by the Bill & Melinda Gates Foundation [OPP1127988].; This publication was made possible through a grant from the Bill & Melinda Gates Foundation [OPP1201031].; The International Vaccine Institute acknowledges its donors including the Republic of Korea and the Swedish International Development Cooperation Agency.; This article was published as part of the supplement “Severe Typhoid Fever in Africa (SETA) Program” sponsored by the International Vaccine Institute.
• Keywords: TRIALS; monitoring; multi-country; Science & Technology; Life Sciences & Biomedicine; Africa; Microbiology; Immunology; epidemiology; Infectious Diseases; Salmonella
• Research Categories: Biology, Microbiology; Health Sciences, Medicine and Surgery; Health Sciences, Public Health

Abstract

Background: There is limited information on the best practices for monitoring multicountry epidemiological studies. Here, we describe the monitoring and evaluation procedures created for the multicountry Severe Typhoid Fever in Africa (SETA) study. Methods: Elements from the US Food and Drug Administration (FDA) and European Centre for Disease Prevention and Control (ECDC) recommendations on monitoring clinical trials and data quality, respectively were applied in the development of the SETA monitoring plan. The SETA core activities as well as the key data and activities required for the delivery of SETA outcomes were identified. With this information, a list of key monitorable indicators was developed using on-site and centralized monitoring methods, and a dedicated monitoring team was formed. The core activities were monitored on-site in each country at least twice per year and the SETA databases were monitored centrally as a collaborative effort between the International Vaccine Institute and study sites. Monthly reports were generated for key indicators and used to guide risk-based monitoring specific for each country. Results: Preliminary results show that monitoring activities have increased compliance with protocol and standard operating procedures. A reduction in blood culture contamination following monitoring field visits in two of the SETA countries are preliminary results of the impact of monitoring activities. Conclusions: Current monitoring recommendations applicable to clinical trials and routine surveillance systems can be adapted for monitoring epidemiological studies. Continued monitoring efforts ensure that the procedures are harmonized across sites. Flexibility, ongoing feedback, and team participation yield sustainable solutions.