Abstract
BackgroundThere 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.MethodsElements 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.ResultsPreliminary 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.ConclusionsCurrent 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.
Highlights
Suspected Salmonella disease in tertiary health facilitiesb enrolling for Severe Typhoid Fever in Africa (SETA): Fever reported for ≥3 consecutive days within the last 7 days in patients living in the defined catchment area OR Clinically suspected typhoid fever patients living in the defined catchment area OR Blood culture positive for Salmonella Typhi/invasive non-typhoidal Salmonella (iNTS)/Salmonella Paratyphi in patients living in the defined catchment area OR Pathognomonic gastrointestinal perforations, even in the absence of laboratory confirmation, in patients living in and outside the defined catchment area AND Informed consent signed 2
Suspected Salmonella disease in primary and secondary health facilitiesb enrolling for SETA: Patients living in the defined catchment area presenting to the healthcare facility with objective fever of ≥38°C tympanic and/or ≥37.5°C axillary OR Fever reported for ≥3 consecutive days within the last 7 days in patients living in the defined catchment area OR Clinically suspected typhoid fever patients living in the defined catchment area OR Blood culture positive for Salmonella Typhi/iNTS/Salmonella Paratyphi in patients living in the defined catchment area OR Pathognomonic gastrointestinal perforations, even in the absence of laboratory confirmation, in patients living in and outside the defined catchment area AND Informed consent signed
We observed that the environment and conditions of the countries participating in SETA vary as is likely to be the case for many multicountry, multisite epidemiological studies
Summary
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. Reports were generated for key indicators and used to guide risk-based monitoring specific for each country
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