The refusal of potential subjects to participate in intervention studies is an important problem in clinical trials. In general, however, relatively little attention to it to the issue. In a study by Elzen and coworkers, a comparison was made between patients who agreed to participate in a self-management intervention (participants) and those who refused (refusers). Compared with other studies of refusers, relatively more information was gathered with regard to both their characteristics and reasons for refusing. Older patients from a Dutch outpatient clinic were invited to participate in a self-management intervention, and their characteristics were assessed. Demographic data were collected, as well as data on physical functioning and lack of emotional support. People who refused to participate were asked to give their reasons for refusing. Of the 361 patients invited to participate in the study, 267 (74%) refused participation. These refusers were more restricted in their mobility, lived further away from the location of the intervention, and had a partner more often than did participants. No differences were found in level of education, age, or gender. The main reasons given by respondents for refusing to participate were lack of time, travel distance, and transport problems.

WHAT THE STUDY MAY MEAN TO YOU AS A HEALTH CARE PROVIDER: The authors noted that the refusal rate in this study was high, and seemed to be related to physical mobility restrictions, travel distance and, partly, to availability of emotional support. These findings, such as offering transportation to the location of the intervention, may be used in the future to make the recruitment process more effective,

WHAT THE STUDY MAY MEAN TO YOU AS A PATIENT: The reasons given by patients in refusing to participate in the study seem reasonable. In many studies, subjects are reimbursed for transportation costs or transportation is provided. Other studies invite members of the subjects’ families to participate in the study. The hope here is that they will not only learn ways to better improve the mobility and care of patients, but will learn skills that can be helpful to them in dealing with their partners. The latter appears particularly effective in helping patients to maintain whatever skills they learn in an intervention program.

H Elzen et al. Do older patients who refuse to participate in a self-management intervention in the Netherlands differ from older patients who agree to participate? Aging Clinical & Experimental Research, 2008;20:266-271.