TY - JOUR
T1 - Translating clinical trials into clinical practice
T2 - A survey assessing the potential impact of the Pediatric Heart Network Infant Single Ventricle Trial
AU - Zak, Victor
AU - Hsu, Daphne T.
AU - Pemberton, Victoria L.
AU - Levine, Jami C.
AU - Atz, Andrew M.
AU - Cnota, James F.
AU - Ravishankar, Chitra
AU - Barker, Piers
AU - Lambert, Linda M.
AU - McCrindle, Brian W.
AU - Frommelt, Michele A.
AU - Altmann, Karen
AU - Chen, Shan
AU - Williams, Richard V.
N1 - Funding Information:
Supported by U01 grants from the National Heart, Lung, and Blood Institute (HL068269, HL068270, HL068279, HL068281, HL068285, HL068292, HL068290, HL068288, and HL085057) and the FDA Office of Orphan Products Development. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NHLBI or the NIH.
Publisher Copyright:
© 2017 Cambridge University Press.
PY - 2017/9/1
Y1 - 2017/9/1
N2 - 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.
AB - 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.
KW - Single-ventricle physiology
KW - angiotensin-converting enzyme inhibitor
KW - physician survey
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U2 - 10.1017/S104795111600295X
DO - 10.1017/S104795111600295X
M3 - Article
C2 - 28183375
AN - SCOPUS:85012177516
SN - 1047-9511
VL - 27
SP - 1265
EP - 1270
JO - Cardiology in the Young
JF - Cardiology in the Young
IS - 7
ER -