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Translating clinical trials into clinical practice: a survey assessing the potential impact of the Pediatric Heart Network Infant Single Ventricle Trial

  • Victor Zak (a1), Daphne T. Hsu (a2), Victoria L. Pemberton (a3), Jami C. Levine (a4), Andrew M. Atz (a5), James F. Cnota (a6), Chitra Ravishankar (a7), Piers Barker (a8), Linda M. Lambert (a9), Brian W. McCrindle (a10), Michele A. Frommelt (a11), Karen Altmann (a12), Shan Chen (a1), Richard V. Williams (a9) and for the Pediatric Heart Network Investigators...
Abstract
Abstract Background

A few studies have evaluated the impact of clinical trial results on practice in paediatric cardiology. The Infant Single Ventricle (ISV) Trial results published in 2010 did not support routine use of the angiotensin-converting enzyme inhibitor enalapril in infants with single-ventricle physiology. We sought to assess the influence of these findings on clinical practice.

Methods

A web-based survey was distributed via e-mail to over 2000 paediatric cardiologists, intensivists, cardiothoracic surgeons, and cardiac advance practice nurses during three distribution periods. The results were analysed using McNemar’s test for paired data and Fisher’s exact test.

Results

The response rate was 31.5% (69% cardiologists and 65% with >10 years of experience). Among respondents familiar with trial results, 74% reported current practice consistent with trial findings versus 48% before trial publication (p<0.001); 19% used angiotensin-converting enzyme inhibitor in this population “almost always” versus 36% in the past (p<0.001), and 72% reported a change in management or improved confidence in treatment decisions involving this therapy based on the trial results. Respondents familiar with trial results (78%) were marginally more likely to practise consistent with the trial results than those unfamiliar (74 versus 67%, p=0.16). Among all respondents, 28% reported less frequent use of angiotensin-converting enzyme inhibitor over the last 3 years.

Conclusions

Within 5 years of publication, the majority of respondents was familiar with the Infant Single Ventricle Trial results and reported less frequent use of angiotensin-converting enzyme inhibitor in single-ventricle infants; however, 28% reported not adjusting their clinical decisions based on the trial’s findings.

Copyright
Corresponding author
Correspondence to: V. Zak, PhD, New England Research Institute, 480 Pleasant Street, Watertown, MA 02472, United States of America. Tel: +617 972 3233; Fax: +617 923 4176; E-mail: vzak@neriscience.com
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Cardiology in the Young
  • ISSN: 1047-9511
  • EISSN: 1467-1107
  • URL: /core/journals/cardiology-in-the-young
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