Recruitment strategies in two reproductive medicine network infertility trials

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 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.

Recruiting ENT and Audiology patients into pharmaceutical trials: evaluating the multi-centre experience in the UK and USA

“…Across the two RCTs, recruitment proved to be more resource intensive and had a higher proportion of screen failures than initially anticipated during trial design and planning, requiring an extension to the recruitment period and the addition of sites. These recruitment struggles are similar to those reported for other disciplines too (Lloyd, Dean, and Ada 2010;Usadi et al 2015).…”

“…Like others (e.g. Usadi et al 2015), professional referrals to CLARITY-1 were found to be most effective when there was an existing close relationship between specialties and the trial team. Similarly, Lloyd, Dean, and Ada (2010) also commented that referral strategies are more successful and efficient than advertising strategies at recruiting community-dwelling stroke survivors.…”

“…While physician referral can be more effective than advertising strategies for some intervention trials (Lloyd, Dean, and Ada 2010;Usadi et al 2015) professional clinical referral was not as successful as had been anticipated at either site. Major eligibility criteria were not routinely assessed in-clinic, so a reasonably large proportion failed on those criteria at the screening visit.…”

“…Similarly a report by Usadi et al (2015), discussed that collaborative communication was positive and beneficial in an evaluation of recruitment strategies for randomised controlled trials involving infertile couples, both QUIET-1 and CLARITY-1 held regular teleconferences between recruiting sites and the trial's data coordinating centre at which monthly enrolment data and effective recruitment strategies were shared and good performing sites were acknowledged. Such techniques seek to achieve ''buy-in'' from collaborators by developing a sense of personal ownership and commitment, techniques perhaps more common to business marketing than to clinical research.…”

Cost analysis and efficacy of recruitment strategies used in a large pragmatic community-based clinical trial targeting low-income seniors: a comparative descriptive analysis

“…This implies that recruitment may be more successful if participants hear about studies from trusted individuals, such as their physicians or pharmacists [2, 27], and it might explain why health care providers enrolled the most participants in our study. Similarly, personal referrals have been shown to be quite successful at persuading people to enroll [2, 11–13, 26, 28, 32, 33]; which we also noted with the success of the ”word of mouth” strategy. Mail-based recruitment strategies can be challenging to implement.…”