Recruitment of participants for the Estrogen Replacement and Atherosclerosis (ERA) trial: A comparison of costs, yields, and participant characteristics from community- and hospital-based recruitment strategies

This paper documents recruitment for the Estrogen Replacement and Atheroscl erosis trial, a multicenter, placebo-controlled, double-blind angiographic trial of the effects of opposed and unopposed estrogen on coronary atherosc lerosis in postmenopausal women (average scheduled duration of follow-up 3. 2 years). We compare costs, yields, and participant characteristics between community-based and hospital-based recruitment strategies. We further comp are community-based enriched sources (i.e., those that allowed self-selecti on or targeted women with known health characteristics) and nonenriched sou rces. Data gathered on potential participants include method of contact, cl inical site, eligibility, completion of screening visits, and randomization rates. Demographic data on participants include age, race, education, mari tal status, and income. Self-reported health status, smoking status, lipid level, ejection fraction as well as history of chest pain, hypertension, an d diabetes were recorded at baseline. Recruitment costswere estimated from employee salaries and costs of screening tests and procedures. Yields were compared by clinical site and by method of contact. Enriched sources of rec ruitment yielded higher percentages of enrolled participants than nonenrich ed sources. Both types of source resulted in demographically similar partic ipants. Costs of community-based recruitment were Less than hospital-based recruitment; however, screening costs were higher. Overall, screening and r ecruitment averaged $2508 per randomized participant. (C) Elsevier Science Inc. 2001.