• Meseret Molla, Henok Negussie, Moses Ngari, Esther Kivaya, Patricia Njuguna, Fikre Enqueselassie, James A Berkley, and Gail Davey.
• Centre for Environment and Development Studies, Addis Ababa University, Addis Ababa, Ethiopia.
• Bmc Med Res Methodol. 2018 Mar 7; 18 (1): 26.

BackgroundWe 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.MethodsWe 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.ResultsWe describe the challenges met, together with strategies employed to overcome them.ConclusionsExamples 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.Trial RegistrationISRCTN67805210, registered 24/01/2013.

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