Design, recruitment, and retention of African-American smokers in a pharmacokinetic study
1 Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, KS, USA
2 Department of General and Geriatric Medicine, University of Kansas Medical Center, Kansas City, KS, USA
3 Department of Pharmacology, Toxicology and Therapeutics, University of Kansas Medical Center, Kansas City, KS, USA
4 Department of Biostatistics, University of Kansas Medical Center, Kansas City, KS, USA
5 Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA
6 Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, MN, USA
7 Program in Health Disparities Research, University of Minnesota Medical School, Minneapolis, MN, USA
BMC Medical Research Methodology 2010, 10:6 doi:10.1186/1471-2288-10-6Published: 19 January 2010
African-Americans remain underrepresented in clinical research despite experiencing a higher burden of disease compared to all other ethnic groups in the United States. The purpose of this article is to describe the study design and discuss strategies used to recruit and retain African-American smokers in a pharmacokinetic study.
The parent study was designed to evaluate the differences in the steady-state concentrations of bupropion and its three principal metabolites between African-American menthol and non-menthol cigarette smokers. Study participation consisted of four visits at a General Clinical Research Center (GCRC) over six weeks. After meeting telephone eligibility requirements, phone-eligible participants underwent additional screening during the first two GCRC visits. The last two visits (pharmacokinetic study phase) required repeated blood draws using an intravenous catheter over the course of 12 hours.
Five hundred and fifteen African-American smokers completed telephone screening; 187 were phone-eligible and 92 were scheduled for the first GCRC visit. Of the 81 who attended the first visit, 48 individuals were enrolled in the pharmacokinetic study, and a total of 40 individuals completed the study (83% retention rate).
Although recruitment of African-American smokers into a non-treatment, pharmacokinetic study poses challenges, retention is feasible. The results provide valuable information for investigators embarking on non-treatment laboratory-based studies among minority populations.