Set-up of GoLBeT, a pragmatic clinical trial of podoconiosis management in a low-resource setting

Clinical trials are often perceived as being expensive, difficult and beyond the capacity of academic groups and healthcare workers in low-resource settings. However, in order to improve healthcare coverage, the WHO World Health Report 2013 stated that all countries need to become generators as well as recipients of data. This study is a methodological examination of the steps and processes involved in setting up the Gojjam Lymphoedema Best Practice Trial (GoLBeT; ISRCTN67805210), a highly pragmatic clinical trial conducted in northern Ethiopia. Challenges to the trial and strategies used to deal with them were explored, together with reasons for delays. A qualitative approach using the Global Health Research Process Map as a framework was used to analyse emails and reports from the period between trial inception and recruitment. This analysis was complemented by interviews with key informants from the operational team and a group discussion. This study showed that the key areas of difficulty in setting up and planning this trial were: the study design (definition and measurement of the study endpoint, and assuring statistical power); recruitment and appropriate training of staff; planning for data quality; and gaining regulatory approvals. Collaboration was essential to successfully setting up the trial. Other important aspects were a team and process perspective, staff training, community engagement, and data quality e.g., through data management. Lessons learnt from this trial might guide in planning pragmatic trials in settings where research is not common, allowing researchers to anticipate challenges and address them through trial design, planning and operational delivery. We also hope that this example might encourage similar pragmatic studies to be undertaken. Such studies are rarely undertaken or locally led, but are an accessible and efficient way to drive improved outcomes in public health.