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

Abstract

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.

Lymphoedema management to prevent acute dermatolymphangioadenitis in podoconiosis in northern Ethiopia (GoLBeT): a pragmatic randomised controlled trial

“…Participants were adults aged 18 years or older, had a diagnosis of at least stage 2 podoconiosis (persistent lymphoedema) 26 and a negative BinaxNOW Filariasis rapid antigen test (Alere Inc, Waltham, MA, USA), and intended to remain within Aneded woreda for the duration of the trial. These participants were identified by Health Extension Workers, who listed potential patients 27 . Participants were excluded if they had a mental or physical disability or disease that would impair their ability to adhere to the intervention, such as a nodular disease preventing use of shoes.…”

Prolonged delays in leprosy case detection in a leprosy hot spot setting in Eastern Ethiopia

“…To aid in the recall problems, the national Ethiopian calendar was used, which runs 7 to 8 years behind the Gregorian calendar, counting 12 months of 30 days plus a thirteenth month of 5 to 6 days. In addition, local events like harvest season and PLOS NEGLECTED TROPICAL DISEASES large political events were added to the calendar, aiming to potentially minimize problems of recall [60,61]. The included picture set further helped participants in remembering and recognizing signs/symptoms [33].…”

Development of a questionnaire to determine the case detection delay of leprosy: A mixed-methods cultural validation study

“…This method was also described in literature [ 36 ]. In Ethiopia, the local calendar was created by combining the solar calendar that is nationally used (the Ethiopian Calendar is 7–8 years behind the Gregorian calendar, comprising of 13 months per year of which the last month counts 5–6 days) with agricultural seasons [ 42 , 43 ]. In Tanzania, the content of the local calendar was extended by adding the agricultural seasons for different types of crops.…”