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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

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.

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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

References

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1. Hsu, DT, Mital, S, Ravishankar, C, et al. Rationale and design of a trial of angiotensin-converting enzyme inhibition in infants with single ventricle. Am Heart J 2009; 157: 3745.
2. Hsu, DT, Zak, V, Mahony, L, et al. Enalapril in infants with single ventricle: results of a multicenter randomized trial. Circulation, 122: 333340.
3. Yancy, CW, Jessup, M, Bozkurt, B, et al. ACCF/AHA guideline for the management of heart failure: executive summary. A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation 2013; 128: 18101852.
4. Yusuf, S, Sleight, P, Pogue, J, Bosch, J, Davies, R, Dagenais, G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators. N Engl J Med 2000; 342: 145153.
5. Rosenthal, D, Chrisant, MR, Edens, E, et al. International Society for Heart and Lung Transplantation: practice guidelines for management of heart failure in children. J Heart Lung Transplant 2004; 23: 13131333.
6. Gantenbein, MH, Bauersfeld, U, Baenziger, O, et al. Side effects of angiotensin converting enzyme inhibitor (captopril) in newborns and young infants. J Perinat Med 2008; 36: 448452.
7. Cabana, MD, Rand, CS, Powe, NR, et al. Why don’t physicians follow clinical practice guidelines? A framework for improvement. JAMA 1999; 282: 14581465.
8. Francke, AL, Smit, MC, de Veer, AJ, Mistiaen, P. Factors influencing the implementation of clinical guidelines for health care professionals: a systematic meta-review. BMC Med Inform Decis Mak 2008; 8: 38.
9. Winkler, JD, Lohr, KN, Brook, RH. Persuasive communication and medical technology assessment. Arch Intern Med 1985; 145: 314317.
10. Antman, EM, Lau, J, Kupelnick, B, Mosteller, F, Chalmers, TC. A comparison of results of meta-analyses of randomized control trials and recommendations of clinical experts. Treatments for myocardial infarction. JAMA 1992; 268: 240248.
11. Burchill, LJ, Ross, HJ, Wald, RM. Letter by Burchill et al. regarding article, “Enalapril in infants with single ventricle: results of a multicenter randomized trial”. Circulation 2011; 123: e373.
12. Singh, TP. Letter by Singh regarding article, “Enalapril in infants with single ventricle: results of a multicenter randomized trial”. Circulation 2011; 123: e374.
13. Editors, T. Circulation Editors’ picks: most read articles in pediatric cardiology. Circulation 2012; 126: e285e293.
14. Editors, T. Circulation Editors’ picks: most read articles highlighting cardiovascular drugs and pharmacology. Circulation 2012; 125: e396e405.

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