Related Experiment Videos
The recruitment process for a multicenter study on the long-term prophylactic treatment of affective disorders
W Greil1, W Ludwig-Mayerhofer, B Steller
1Psychiatric Hospital, University of Munich, Germany.
Abstract:
The paper reports on the process of patient recruitment for a controlled clinical multicenter study on the treatment of affective disorders. Two thirds of the patients screened did not participate because prophylactic treatment was either unnecessary or not justified for medical reasons. Further, a number of patients equal to that eventually allocated to the trial refused to participate for personal, idiosyncratic reasons. In spite of this, the patients in the trial were very similar to those not participating with respect to relevant variables such as age, sex, number of and intervals between previous episodes or severity of the present episode.
Insights
Patient recruitment for affective disorder trials faced challenges, with many excluded due to treatment appropriateness or personal reasons. However, trial participants remained representative of the screened population.
Area of Science:
- Clinical Psychology
- Psychiatry
- Medical Research
Background:
- Recruitment is crucial for clinical trials.
- Affective disorders require effective treatment strategies.
Purpose of the Study:
- To detail patient recruitment for a clinical trial on affective disorders.
- To analyze reasons for patient non-participation.
Main Methods:
- Screening patients for a controlled multicenter study.
- Documenting reasons for exclusion and refusal.
- Comparing participant and non-participant demographics and clinical variables.
Main Results:
- Two-thirds of screened patients were excluded due to treatment necessity.
- An equal number refused participation for personal reasons.
- Participants were similar to non-participants in age, sex, and episode history.
Conclusions:
- Patient recruitment for affective disorder trials presents significant hurdles.
- Non-participation reasons vary from medical judgment to personal choice.
- Ensuring participant representativeness is vital despite recruitment challenges.