Erber 2021 Setting up GoLBeT.pdf (865.77 kB)
Set-up of GoLBeT, a pragmatic clinical trial of podoconiosis management in a low-resource setting
conference contribution
posted on 2023-06-10, 06:11 authored by A Erber, V Ewing, M Turner, M Molla, G Murbe, Gail DaveyGail Davey, T LangClinical trials are often perceived as being expensive, difficult and beyond the capacity of academic groups and healthcare workers in low-resource settings. However, in order to improve healthcare coverage, the WHO World Health Report 2013 stated that all countries need to become generators as well as recipients of data. This study is a methodological examination of the steps and processes involved in setting up the Gojjam Lymphoedema Best Practice Trial (GoLBeT; ISRCTN67805210), a highly pragmatic clinical trial conducted in northern Ethiopia. Challenges to the trial and strategies used to deal with them were explored, together with reasons for delays. A qualitative approach using the Global Health Research Process Map as a framework was used to analyse emails and reports from the period between trial inception and recruitment. This analysis was complemented by interviews with key informants from the operational team and a group discussion. This study showed that the key areas of difficulty in setting up and planning this trial were: the study design (definition and measurement of the study endpoint, and assuring statistical power); recruitment and appropriate training of staff; planning for data quality; and gaining regulatory approvals. Collaboration was essential to successfully setting up the trial. Other important aspects were a team and process perspective, staff training, community engagement, and data quality e.g., through data management. Lessons learnt from this trial might guide in planning pragmatic trials in settings where research is not common, allowing researchers to anticipate challenges and address them through trial design, planning and operational delivery. We also hope that this example might encourage similar pragmatic studies to be undertaken. Such studies are rarely undertaken or locally led, but are an accessible and efficient way to drive improved outcomes in public health.
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Publication status
- Published
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- Published version
Journal
European Journal of Public HealthISSN
1101-1262Publisher
Oxford University Press (OUP)External DOI
Issue
3Volume
31Event name
14th European Public Health Conference Statement: Public health futures in a changing worldEvent location
VirtualEvent type
conferenceEvent date
10-12 November 2021Department affiliated with
- Global Health and Infection Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2023-02-07First Open Access (FOA) Date
2023-02-07First Compliant Deposit (FCD) Date
2023-02-06Usage metrics
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