OFFERING A RANDOMIZED TRIAL OF INTENSIVE THERAPY FOR IDDM TO ADOLESCENTS - REASONS FOR REFUSAL, PATIENT CHARACTERISTICS, AND RECRUITER EFFECTS

OBJECTIVE - To identify reasons adolescents refuse to participate in a randomized trial of intensive therapy (IT) for IDDM, to describe the patient characteristics of those who consent and those who refuse to p articipate, and to examine recruiter effects on trial participation ra tes. RESEARCH DESIGN AND METHODS - A total of 99 adolescents, age 11-1 8 years, were provided with the results of the Diabetes Control and Co mplications Trial and approached for possible study participation by t wo nurse recruiters. Adolescents refusing the trial were administered a semi-structured interview to describe reasons for study refusal; res ponses were recorded and later coded into categories. Patient characte ristics of consenters and refusers were collected and compared. The di fferential enrollment rates of the two nurse recruiters were also comp ared. RESULTS - A total of 56 patients (similar to 57%) agreed to part icipate; 43 refused. The four most common reasons for study refusal we re 1) increased clinic visits (42%), 2) increased insulin injections ( 30%), 3) increased frequency of self-monitoring of blood glucose (SMBG ) (28%), and 4) transportation difficulties (19%). Concerns about rand omization to an unwanted treatment condition and fears of hypoglycemia or weight gain were rarely cited. Consenters and refusers did not dif fer in demographic characteristics, disease status, or family composit ion. Large differences were found between the two nurse recruiters. on e experienced a 60% refusal rate, while the other experienced a 27% re fusal rate. CONCLUSIONS - Issues of convenience (increased clinic visi ts, transportation difficulties) and concerns about the demands of IT (increased injections and SMBG) were the predominant reasons for trial refusal. Patient characteristics did not differentiate consenters fro m refusers. However, recruiters differed greatly in study refusal rate s, suggesting that provider behavior may be an important but understud ied aspect of adolescent acceptance of randomized trials in general an d IT in particular.