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

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.
TRIAL REGISTRATION: ISRCTN67805210, registered 24/01/2013.
PMID: 29514613 [PubMed - in process]

Source: Rural Remote Health - March 7, 2018 Category: Rural Health Authors: Molla M, Negussie H, Ngari M, Kivaya E, Njuguna P, Enqueselassie F, Berkley JA, Davey G Tags: BMC Med Res Methodol Source Type: research