Retrospective analysis of a South African cardiovascular trial site’s patient retention rates

Abstract

Correspondence: Lesley J Burgess TreAD research/Cardiology Unit, Department of internal Medicine, Tygerberg hospital and Stellenbosch University, Parow, South Africa Tel +27 21 931 7825 Fax +27 21 933 3597 email lesley@treadresearch.com Introduction: Patient dropouts negatively affect study cost and validity of study results. Objectives: To investigate the attrition rate and reasons for patient discontinuations at a cardiovascular trial site in South Africa. Methods: Studies conducted over the past 10 years were randomly selected and retrospectively examined for attrition rates and reasons for patient discontinuation. Results: A total of 50 studies with a duration ranging from 3 to 45 months were examined. A total of 1386 patients were randomized. Of these, 88.9% completed all scheduled study visits, resulting in a mean 11.1% (n = 154) attrition rate. Reasons for discontinuation included death (39.6%), withdrawal of consent (33.1%), adverse events (22.7%), and relocation (4.5%). There were no patients lost to follow-up. Conclusion: The low attrition rate and absence of any patients lost to follow-up are the result of a dedicated retention plan in which each site staff member has a crucial role to play in keeping patients motivated and interested in participating in a clinical trial.