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Challenges and successes of recruitment in the “angiotensin-converting enzyme inhibition in infants with single ventricle trial” of the Pediatric Heart Network

  • Nancy A. Pike (a1), Victoria Pemberton (a2), Kerstin Allen (a3), Jeffrey P. Jacobs (a4), Daphne T. Hsu (a5), Alan B. Lewis (a6), Nancy Ghanayem (a7), Linda Lambert (a8), Kari Crawford (a9), Teresa Atz (a10), Rosalind Korsin (a11), Mingfen Xu (a12), Chitra Ravishankar (a13), James Cnota (a14) and Gail D. Pearson (a2)...
  • Please note a correction has been issued for this article.

Abstract

Objectives

Identify trends of enrolment and key challenges when recruiting infants with complex cardiac diseases into a multi-centre, randomised, placebo-controlled drug trial and assess the impact of efforts to share successful strategies on enrolment of subjects.

Methods

Rates of screening, eligibility, consent, and randomisation were determined for three consecutive periods of time. Sites collectively addressed barriers to recruitment and shared successful strategies resulting in the Inventory of Best Recruiting Practices. Study teams detailed institutional practices of recruitment in post-trial surveys that were compared with strategies of enrolment initially proposed in the Inventory.

Results

The number of screened patients increased by 30% between the Initial Period and the Intermediate Period (p = 0.007), whereas eligibility decreased slightly by 7%. Of those eligible for entry into the study, the rate of consent increased by 42% (p = 0.025) and randomisation increased by 71% (p = 0.10). During the Final Period, after launch of a competing trial, fewer patients were screened (−14%, p = 0.06), consented (−19%, p = 0.12), and randomised (−34%, p = 0.012). Practices of recruitment in the post-trial survey closely mirrored those in the Inventory.

Conclusions

Early identification and sharing of best strategies of recruitment among all recruiting sites can be effective in increasing recruitment of critically ill infants with congenital cardiac disease and possibly other populations. Strategies of recruitment should focus on those that build relationships with families and create partnerships with the medical providers who care for them. Competing studies pose challenges for enrolment in trials, but fostering trusting relationships with families can result in successful enrolment into multiple studies.

Copyright

Corresponding author

Correspondence to: Dr N. Pike, PhD, RN, UCLA School of Nursing, 700 Tiverton Avenue, Factor Building Room no. 3-938, Los Angeles, California 90095, United States of America. Tel: 310 206 3683; Fax: 310 267 0413; E-mail: npike@sonnet.ucla.edu

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