Rebecca S Usadi1, Michael P Diamond2, Richard S Legro3, William D Schlaff4, Karl R Hansen5, Peter Casson6, Gregory Christman7, G Wright Bates8, Valerie Baker9, Aimee Seungdamrong10, Mitchell P Rosen11, Scott Lucidi12, Tracey Thomas13, Hao Huang14, Nanette Santoro15, Esther Eisenberg16, Heping Zhang14, Ruben Alvero15. 1. Carolinas Healthcare System Reproductive Medicine and Infertility, 1025 Morehead Medical Dr., Charlotte, NC 28232, United States. Electronic address: Rebecca.Usadi@carolinashealthcare.org. 2. Department of Obstetrics and Gynecology, Georgia Regents University, Augusta, GA 30912, United States. 3. Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, PA 17033, United States. 4. Department of Obstetrics and Gynecology, Jefferson University, Philadelphia PA 19107, United States. 5. Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK 73104, United States. 6. Northeastern Reproductive Medicine, Colchester VT 05446, United States. 7. Department of Obstetrics and Gynecology, University of Florida, Gainesville, FL 32606, United States. 8. Department of Obstetrics and Gynecology, University of Alabama Birmingham, Birmingham, AL 35233, United States. 9. Department of Obstetrics and Gynecology, Stanford University Medical Center, Stanford, CA 94304, United States. 10. University of Medicine and Dentistry of New Jersey, Newark, NJ 07101, United States. 11. Department of Reproductive Endocrinology and Infertility, University of California, San Francisco, CA 94115, United States. 12. Department of Obstetrics and Gynecology, Virginia Commonwealth University, Richmond, VA 23235, United States. 13. Collaborative Center for Statistics in Science, Yale School of Public Health, New Haven, CT 06511, United States. 14. Department of Biostatistics, Yale University School of Public Health, New Haven, CT 06520, United States. 15. Department of Obstetrics and Gynecology, University of Colorado Denver, Aurora, CO 80045, United States. 16. Fertility and Infertility Branch, Eunice Kennedy Shriver National Institutes of Child Health and Human Development, Rockville, MD 20847, United States.
Abstract
BACKGROUND: Recruitment of individuals into clinical trials is a critical step in completing studies. Reports examining the effectiveness of different recruitment strategies, and specifically in infertile couples, are limited. METHODS: We investigated recruitment methods used in two NIH sponsored trials, Pregnancy in Polycystic Ovary Syndrome (PPCOS II) and Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS), and examined which strategies yielded the greatest number of participants completing the trials. RESULTS:3683 couples were eligible for screening. 1650 participants were randomized and 1339 completed the trials. 750 women were randomized in PPCOS II; 212 of the participants who completed the trial were referred by physicians. Participants recruited from radio ads (84/750) and the internet (81/750) resulted in similar rates of trial completion in PPCOS II. 900 participants were randomized in AMIGOS. 440 participants who completed the trial were referred to the study by physicians. The next most successful method in AMIGOS was the use of the internet, achieving 78 completed participants. Radio ads proved the most successful strategy in both trials for participants who earned <$50,000 annually. Radio ads were most successful in enrolling white patients in PPCOS II and black patients in AMIGOS. Seven ancillary Clinical Research Scientist Training (CREST) sites enrolled 324 of the participants who completed the trials. CONCLUSIONS: Physician referral was the most successful recruitment strategy. Radio ads and the internet were the next most successful strategies, particularly for women of limited income. Ancillary clinical sites were important for overall recruitment.
RCT Entities:
BACKGROUND: Recruitment of individuals into clinical trials is a critical step in completing studies. Reports examining the effectiveness of different recruitment strategies, and specifically in infertile couples, are limited. METHODS: We investigated recruitment methods used in two NIH sponsored trials, Pregnancy in Polycystic Ovary Syndrome (PPCOS II) and Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS), and examined which strategies yielded the greatest number of participants completing the trials. RESULTS: 3683 couples were eligible for screening. 1650 participants were randomized and 1339 completed the trials. 750 women were randomized in PPCOS II; 212 of the participants who completed the trial were referred by physicians. Participants recruited from radio ads (84/750) and the internet (81/750) resulted in similar rates of trial completion in PPCOS II. 900 participants were randomized in AMIGOS. 440 participants who completed the trial were referred to the study by physicians. The next most successful method in AMIGOS was the use of the internet, achieving 78 completed participants. Radio ads proved the most successful strategy in both trials for participants who earned <$50,000 annually. Radio ads were most successful in enrolling white patients in PPCOS II and black patients in AMIGOS. Seven ancillary Clinical Research Scientist Training (CREST) sites enrolled 324 of the participants who completed the trials. CONCLUSIONS: Physician referral was the most successful recruitment strategy. Radio ads and the internet were the next most successful strategies, particularly for women of limited income. Ancillary clinical sites were important for overall recruitment.
Authors: Shaun Treweek; Elizabeth Mitchell; Marie Pitkethly; Jonathan Cook; Monica Kjeldstrøm; Taina Taskila; Marit Johansen; Frank Sullivan; Sue Wilson; Catherine Jackson; Ritu Jones Journal: Cochrane Database Syst Rev Date: 2010-01-20
Authors: Richard S Legro; Robert G Brzyski; Michael P Diamond; Christos Coutifaris; William D Schlaff; Peter Casson; Gregory M Christman; Hao Huang; Qingshang Yan; Ruben Alvero; Daniel J Haisenleder; Kurt T Barnhart; G Wright Bates; Rebecca Usadi; Scott Lucidi; Valerie Baker; J C Trussell; Stephen A Krawetz; Peter Snyder; Dana Ohl; Nanette Santoro; Esther Eisenberg; Heping Zhang Journal: N Engl J Med Date: 2014-07-10 Impact factor: 91.245
Authors: Sravya Kakumanu; Braden J Manns; Sophia Tran; Terry Saunders-Smith; Brenda R Hemmelgarn; Marcello Tonelli; Ross Tsuyuki; Noah Ivers; Danielle Southern; Jeff Bakal; David J T Campbell Journal: Trials Date: 2019-10-07 Impact factor: 2.279
Authors: Esther Eisenberg; Richard S Legro; Michael P Diamond; Hao Huang; Louise M O'Brien; Yolanda R Smith; Christos Coutifaris; Karl R Hansen; Nanette Santoro; Heping Zhang Journal: J Clin Endocrinol Metab Date: 2021-10-21 Impact factor: 6.134
Authors: Ida Darmawan; Caitlin Bakker; Tabetha A Brockman; Christi A Patten; Milton Eder Journal: J Med Internet Res Date: 2020-10-26 Impact factor: 5.428