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 participate, and to examine recruiter effects on trial participation rates. RESEARCH DESIGN AND METHODS - A total of 99 adolescents, age 11-18 years, were provided with the results of the Diabetes Control and Complications Trial and approached for possible study participation by two nurse recruiters. Adolescents refusing the trial were administered a semi-structured interview to describe reasons for study refusal; responses were recorded and later coded into categories. Patient characteristics of consenters and refusers were collected and compared. The differential enrollment rates of the two nurse recruiters were also compared. RESULTS - A total of 56 patients (similar to 57%) agreed to participate; 43 refused. The four most common reasons for study refusal were 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 randomization to an unwanted treatment condition and fears of hypoglycemia or weight gain were rarely cited. Consenters and refusers did not differ in demographic characteristics, disease status, or family composition. Large differences were found between the two nurse recruiters. one experienced a 60% refusal rate, while the other experienced a 27% refusal rate. CONCLUSIONS - Issues of convenience (increased clinic visits, 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 from refusers. However, recruiters differed greatly in study refusal rates, suggesting that provider behavior may be an important but understudied aspect of adolescent acceptance of randomized trials in general and IT in particular.