Recruitment strategies in the studies of left ventricular dysfunction (SOLVD): strategies for screening and enrollment in two concurrent but separate trials. The SOLVD Investigators.
SOLVD was a double-masked, placebo-controlled trial whose initial sample size goal was to randomize 6100 participants into two concurrent trials: treatment and prevention. The objective was to determine if participants with severe left ventricular dysfunction (left ventricular ejection fraction < or = 35%, with congestive heart failure (2569) and participants without overt heart failure (4228) had improved survival with angiotensin-converting enzyme inhibitors. Participants were identified from cardiac catheterization, echocardiography and radionuclide laboratories, and inpatient units. The treatment trial recruitment goal was attained 13 months ahead of schedule while recruitment for the prevention trial was extended 11 months beyond the scheduled time. Recruitment of relatively asymptomatic participants with a low ejection fraction in a hospital-based trial necessitated novel strategies. Coronary care units and clinics for follow-up of acute cardiac conditions, not typically employed in studies of chronic diseases, were useful recruitment sources. Different approaches to encourage participation also needed to be employed. Expanding selected entry criteria was evaluated and the success of varying strategies was reviewed. The authors recommend tailoring of strategies to the target population, staffing flexibility, principal investigator involvement, and broad entry criteria in recruitment activities.
Carew
B D
BD
Division of Cardiology, Dalhousie University, Halifax, NS.
Ahn
S A
SA
Boichot
H D
HD
Dierenfeldt
B J
BJ
Dolan
N A
NA
Edens
T R
TR
Weiner
D H
DH
Probstfield
J L
JL
D002302:Cardiac Output / Q000187:drug effects; D002986:Clinical Trials as Topic / Q000379:methods*; D004311:Double-Blind Method; D004656:Enalapril / Q000627:therapeutic use*; D006333:Heart Failure / Q000188:drug therapy* / Q000401:mortality / Q000517:prevention & control; D006801:Humans; D015996:Survival Rate; D016277:Ventricular Function, Left / Q000187:drug effects*
D004656:Enalapril