Neurourology and Urodynamics 953-62 (1990) zy Recruitment Experiences in a Stress Incontinence Clinical Trial Patricia A. Burns, Thomas Nochajski, Patricia Clesse Desotelle, and Kevin Pranikoff zyxwvut School zyxwvutsrq of Nursing zyxwvutsr (P.A.B., P.C.D.) and Department of Uro/ogy (K.P.), Sfate University of New York, and Research Institute zyxwvuts on Alcoholism (T.N.), Buffalo zyxw Major dclays and subsequent altcrations in randomized controlled clinical trials have been attributcd to poor or failed recruitment. This paper presents the recruitment methods used successfully to obtain a homogenous sample of females with stress urinary incontinence. This sample was recruited to investigate the effectiveness of a behavioral treatment. Recruitment methods and their cost effectiveness are presented for the trial’s three year duration. Yields are presented as ratios of recruited/ randomized subjects. Analysis showed professional referrals to have the lowest cost/yield, while newspaper advertisement produced the highest recruitedisubject retention. As a result of this trial’s experiences recoinmendations were made for differing recruitment strategies according to sourceiyield with additional special plans for recruiting elderly, lower income, inner city, or minority subjects. Key words: randomized clinical trial (RCT), cost effectiveness INTRODUCTION Many clinical trials have been severely hampered or defeated in their investi- gative capabilities as a result of poor or failed recruitment. Some of these trials have experienced major delays in the recruitment process which consequently led to decreasing the sample size, altering the entry criteria, or extending the recruitment phase [Benedict, 1979; Collins et al., 1980; Baines, 1984; Fink, 1972; Croke, 1979; Ratzen, 19811. While many clinical trial investigators have attempted to avert these consequences with elaborate recruitment protocols, often these efforts have still proven to be inadequate in obtaining an expedient appropriate sample. Randomized clinical trials have been identified by the National Institute on Aging as a priority for testing the efficacy of incontinence treatments [Consensus Conference, 1988, NIA Workshop, April, 19831, yet a paucity of literature exists which identifies recruitment Received for publication June zyxwvut 5, 1989; accepted July 11, 1989. This work was supported by National Institute on Aging and Divibion of Nursing grant 5UOIAG05260. Abbreviations used: MESA-Michigan Epidemiological Study on Aging. Address reprint requests to Patricia A. Burns, Ph.D., State University of New York, 3435 Main Street, 806 Kimball Tower, Buffalo, NY 14214. zyxwvu 0 1990 Wiley-Liss, tnc.