Inclusion of frail elderly patients in clinical trials: solutions to the problems.

With the aging of the population, the interest in clinical trials concerning frail elderly patients has increased. Evidence-based practice for the elderly patient is difficult because elderly patients, especially the frail, are often excluded from clinical trials. To facilitate the participation of frail elderly patients in clinical trials, investigators should be more aware of possible barriers when setting up research. While conducting a trial entitled 'A randomized controlled trial of geriatric liaison intervention in frail surgical oncology patients' (LIFE) the main problem was low inclusion rates. This was due to: 1) limited physical and cognitive reserve of frail elderly patients making participation and extra visits to the hospital a burden for patients; 2) difficulty with understanding written information and information given by telephone; and 3) insufficient awareness of the study by health care professionals. To increase inclusion rates, follow-up measurements were taken at a home visit. To overcome barriers to understanding written information and information given over the phone, patients were informed face to face and questionnaires were filled in an interview format. To increase awareness, posters, pencil and sweets with the logo of the study were distributed and the study protocol was repeatedly explained to new staff. Moreover, it was checked if possible eligible patients coming to the hospital were indeed screened for participation. The mentioned measures, increased inclusion rates but also caused an increased time investment and consequently extra financial resources for staff costs.