Pragmatism in practice: lessons learned during screening and enrollment for a randomised controlled trial in rural northern Ethiopia

Molla, Meseret, Negussie, Henok, Ngari, Moses, Kivaya, Esther, Njuguna, Patricia, Enqueselassie, Fikre, Berkley, James A and Davey, Gail (2018) Pragmatism in practice: lessons learned during screening and enrollment for a randomised controlled trial in rural northern Ethiopia. BMC Medical Research Methodology, 18 (26). pp. 1-8. ISSN 1471-2288

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Abstract

Background.
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.

Item Type: Article
Keywords: external validity; internal validity; lessons; pragmatic; randomised controlled trial
Schools and Departments: Brighton and Sussex Medical School > Global Health and Infection
Research Centres and Groups: Wellcome Trust Brighton and Sussex Centre for Global Health Research
Depositing User: Esther Garibay
Date Deposited: 20 Mar 2018 12:28
Last Modified: 20 Mar 2018 12:28
URI: http://sro.sussex.ac.uk/id/eprint/74522

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