Designing Medical and Educational Intervention Studies: A review of some alternatives to conventional randomized controlled trials

Clare Bradley

doi:10.2337/diacare.16.2.509

Behavioral Diabetes Series

Designing Medical and Educational Intervention Studies: A review of some alternatives to conventional randomized controlled trials

Clare Bradley, PHD

University of London, London, United Kingdom Joint Appointment Between The Department of General Practice, United Medical and Dental Schools of Guy's and St. Thomas's Hospitals, Guy's Campus London Bridge, London Department of Psychology, Royal Holloway and Bedford New College, Egham Hlll Egham, Surrey, United Kingdom

Address Correspondence and Reprint Requests to Clare Bradley, PHD, Department of Psychology, Royal Holloway and Bedford New College, Egham Hill, Egham, Surrey, TW20 OEX, UK.

Diabetes Care 1993 Feb; 16(2): 509-518. https://doi.org/10.2337/diacare.16.2.509

Abstract

The advantages and limitations of RCT designs are discussed, and a range of alternative designs for medical and educational intervention studies considered. Designs selected are those that address the much neglected psychological issues involved in the recruitment of patients and allocation of patients to treatments within trials. Designs include Zelen's (18) randomized consent design, Brewin and Bradley's (20) partially randomized patient-centered design, and Korn and Baumrind's (21) partially randomized clinician-centered design. The possibilities of combining features from each of the last two designs are illustrated, and the advantages of adopting a more flexible and clinically relevant approach to the design of clinical trials are discussed.