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.