Multicentre Trials: Planning and Achieving TOTAL

Abstract

This article provides an overview for those conducting multicentre rehabilitation trials. It aims to highlight potential problems and difficulties which may not be obvious initially. TOTAL (Trial of Occupational Therapy and Leisure) was a multicentre rehabilitation trial. The aim was to test whether a leisure-based intervention was more effective than activities of daily living (ADL) based therapy at improving the mood, leisure participation and independence in ADL of stroke patients. During the study period, 466 patients were recruited from five centres in the United Kingdom. Postal assessments were sent out at 6 and 12 months after discharge to evaluate mood, leisure independence and ADL performance. The possible difficulties in recruiting centres are presented. The problems encountered were staff shortages, insufficient numbers of patients, concern over aspects of the protocol and funding issues. Day-to-day problems in running the trial and how these may be resolved are also discussed, such as access to the trial coordinator, finance, the need for written agreements and regular communication with each centre. While the complexity of conducting a multicentre trial should not be underestimated, preparation, good planning and an awareness of potential problems makes it a feasible proposition.