Randomized Controlled Trial Designs for Operations Research in Low-Income Countries: Reality or Delusion?

Abstract

Operational research studies have commonly used cross-sectional, case-control, or cohort designs, but the authors based on their experience in Uganda, put forward the case for including RCTs. Key elements of the RCT conducted in Uganda included generation of the research questions based on challenges identified within the NationalAIDS Control Program, involvement and engagement of program staff right from the outset, use of data being collected under routine careconditions, and making use of existing usual program staff and otherresources. Developmental activity included modification of educational materials and data-collection tools already available and training ofhealth workers to implement interventions. A competent research officerwas employed to work alongside the program staff to facilitate the whole study. In operational research studies where the intervention is at thedistrict level or several facilities are involved, the authors state that a cluster RCT is to be preferred to the individual RCT design. This research is funded under the Department for International Development’s COMDIS-HSD Programme which is led by the University of Leeds