Recruitment strategies used in the medical therapy of prostatic symptoms (MTOPS) trial

Abstract

s 97S P38 RECRUITMENT STRATEGIES USED IN THE MEDICAL THERAPY OF PROSTATIC SYMPTOMS (MTOPS) TRIAL Pamela K. Burrows, John W. Kusek, Kevin McVary, Harry Clarke, Harris Foster, Aaron Kirkemo, Valory Pavlik, and Zana Parman for the MTOPS Research Group. George Washington University Rockville, Maryland MTOPS is a 17-center randomized, placebo controlled clinical trial of drug therapy in men (sample size = 2,800, randomized in 2 years) with benign prostatic hyperplasia (BPH). Although several large multi-center clinical trials have evaluated the effects of drug therapy on BPH, specific recruitment strategies have not been previously described in men with this condition. The target population for MTOPS is men > 50 years of age with reduced urinary flow rates and an American Urological Association Symptom Severity Score > 8 and < 30. As of August 4, 1997, 2106 men have been randomized (75 % of goal for the first 20 months of recruitment) into the trial. The first screen efficiency and proportion of randomized participants for each recruitment strategy is shown below. Recruitment Strategy First Screen Efficiency* Percent of Randomized Newspaper 79.5 28.9 Mail 77.0 23.2 Physician Referral 85.8 11.2 Newsletter 74.8 9.7 Television 87.7 8.5 Radio 82.0 6.5 Word of Mouth 83.0 4.2 Poster/Display 73.5 4.1 Event/Presentation 86.4 0.9 Total 79.9 100.0 *First screen efficiency: number randomized/number completing first screening visit We conclude that all of the recruitment strategies used in MTOPS yield a high proportion of randomized participants from the first screening visit and that targeted mass mailing and newspaper advertising/feature articles account for approximately one-half of the randomized participants.