Mogeni, Ondari D., Espinoza, Ligia Maria Cruz, Im, Justin, Panzner, Ursula, Toy, Trevor, Pak, Gi Deok, Haselbeck, Andrea, Ramani, Enusa, Schuett-Gerowitt, Heidi, Jacobs, Jan, Metila, Octavie Lunguya, Adewusi, Oluwafemi J., Okeke, Iruka N., Ogunleye, Veronica I., Owusu-Dabo, Ellis, Rakotozandrindrainy, Raphael, Soura, Abdramane Bassiahi, Teferi, Mekonnen, Roy, Keriann Conway, Macwright, William, Breiman, Robert F., Kim, Jerome H., Mogasale, Vittal ORCID: 0000-0003-0596-8072, Baker, Stephen, Park, Se Eun and Marks, Florian (2019). The Monitoring and Evaluation of a Multicountry Surveillance Study, the Severe Typhoid Fever in Africa Program. Clin. Infect. Dis., 69. S. S510 - 9. CARY: OXFORD UNIV PRESS INC. ISSN 1537-6591

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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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Mogeni, Ondari D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Espinoza, Ligia Maria CruzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Im, JustinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Panzner, UrsulaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Toy, TrevorUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pak, Gi DeokUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haselbeck, AndreaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ramani, EnusaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schuett-Gerowitt, HeidiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jacobs, JanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Metila, Octavie LunguyaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Adewusi, Oluwafemi J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Okeke, Iruka N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ogunleye, Veronica I.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Owusu-Dabo, EllisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rakotozandrindrainy, RaphaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Soura, Abdramane BassiahiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Teferi, MekonnenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roy, Keriann ConwayUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Macwright, WilliamUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Breiman, Robert F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kim, Jerome H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mogasale, VittalUNSPECIFIEDorcid.org/0000-0003-0596-8072UNSPECIFIED
Baker, StephenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Park, Se EunUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Marks, FlorianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-127541
DOI: 10.1093/cid/ciz597
Journal or Publication Title: Clin. Infect. Dis.
Volume: 69
Page Range: S. S510 - 9
Date: 2019
Publisher: OXFORD UNIV PRESS INC
Place of Publication: CARY
ISSN: 1537-6591
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
TRIALSMultiple languages
Immunology; Infectious Diseases; MicrobiologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/12754

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