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Pragmatism in practice: lessons learned during screening and enrollment for a randomised controlled trial in rural northern Ethiopia
journal contribution
posted on 2023-06-09, 12:31 authored by Meseret Molla, Henok Negussie, Moses Ngari, Esther Kivaya, Patricia Njuguna, Fikre Enqueselassie, James A Berkley, Gail DaveyGail DaveyBackground. We use the example of the Gojjam Lymphoedema Best Practice Trial (GoLBeT), a pragmatic trial in a remote rural setting in northern Ethiopia, to extract lessons relevant to other investigators balancing the demands of practicality and community acceptability with internal and external validity in clinical trials. Methods. We explain in detail the preparation for the trial, its setting in northern Ethiopia, the identification and selection of patients (inclusion and exclusion criterion, identifying and screening of patients at home, enrollment of patients at the health centres and health posts), and randomisation. Results. We describe the challenges met, together with strategies employed to overcome them. Conclusions. Examples given in the previous section are contextualised and general principles extracted where possible. We conclude that it is possible to conduct a trial that balances approaches that support internal validity (e.g. careful design of proformas, accurate case identification, control over data quality and high retention rates) with those that favour generalisability (e.g. ‘real world’ setting and low rates of exclusion). Strategies, such as Rapid Ethical Assessment, that increase researchers’ understanding of the study setting and inclusion of hard-to-reach participants are likely to have resource and time implications, but are vital in achieving an appropriate balance.
History
Publication status
- Published
File Version
- Published version
Journal
BMC Medical Research MethodologyISSN
1471-2288Publisher
BioMed CentralExternal DOI
Issue
26Volume
18Page range
1-8Department affiliated with
- Global Health and Infection Publications
Research groups affiliated with
- Wellcome Trust Brighton and Sussex Centre for Global Health Research Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2018-03-20First Open Access (FOA) Date
2018-03-20First Compliant Deposit (FCD) Date
2018-03-19Usage metrics
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