An alternative trial design to overcome validity and recruitment problems in primary care research

Abstract

Background. Although the randomized controlled trial is widely accepted as the best design to investigate new interventions, conducting a trial in primary care may present researchers with many methodological problems. Objective. Our aim was to present an alternative trial design to overcome internal validity and recruitment problems. Methods. In a randomized controlled trial, fatigued employees absent from work were selected among the population of an occupational health service in the South of The Netherlands. Patients randomly assigned to the experimental condition received cognitive behavioural therapy by a research GP near their home address, whereas patients in the control group received no intervention. We describe our considerations for building an alternative design. Research GPs and patients were recruited separately for the study. The pre-randomization design was applied. Results. Nine research GPs performed all the interventions. Seventy-six experimental patients and 75 control patients were selected for study participation. Of these, only six patients in the experimental group and seven patients in the control group withdrew from the study at some point during follow-up. Conclusion. Results suggest that recruitment and randomization procedures in the alternative design served their purpose well. The alternative design proposed here might have several advantages compared with conventional trial procedures. However, our design is not widely applicable and there are ethical aspects involved that should be considered. Researchers should address their creativity when trying to minimize the problems they may encounter in designing a study. © Oxford University Press 2004, all rights reserved.