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将临床试验转化为临床实践:一项评估小儿心脏网络婴儿单心室试验潜在影响的调查。

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

作者信息

Zak Victor, Hsu Daphne T, Pemberton Victoria L, Levine Jami C, Atz Andrew M, Cnota James F, Ravishankar Chitra, Barker Piers, Lambert Linda M, McCrindle Brian W, Frommelt Michele A, Altmann Karen, Chen Shan, Williams Richard V

机构信息

1New England Research Institute,Watertown,Massachusetts.

2Children's Hospital at Montefiore/Albert Einstein College of Medicine,New York,New York.

出版信息

Cardiol Young. 2017 Sep;27(7):1265-1270. doi: 10.1017/S104795111600295X. Epub 2017 Feb 10.

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.

摘要

背景

少数研究评估了临床试验结果对儿科心脏病学实践的影响。2010年发表的婴儿单心室(ISV)试验结果不支持在具有单心室生理特征的婴儿中常规使用血管紧张素转换酶抑制剂依那普利。我们试图评估这些研究结果对临床实践的影响。

方法

在三个分发阶段,通过电子邮件向2000多名儿科心脏病专家、重症监护医生、心胸外科医生和心脏专科执业护士发放了一项基于网络的调查问卷。使用配对数据的McNemar检验和Fisher精确检验对结果进行分析。

结果

回复率为31.5%(心脏病专家占69%,有超过10年经验的占65%)。在熟悉试验结果的受访者中,74%报告目前的实践与试验结果一致,而在试验发表前这一比例为48%(p<0.001);19%在这一人群中“几乎总是”使用血管紧张素转换酶抑制剂,而过去这一比例为36%(p<0.001),72%报告基于试验结果在涉及该疗法的管理方面有改变或对治疗决策的信心有所提高。熟悉试验结果的受访者(78%)比不熟悉的受访者(74%对67%,p=0.16)稍微更有可能按照试验结果进行实践。在所有受访者中,28%报告在过去3年中使用血管紧张素转换酶抑制剂的频率降低。

结论

在发表后的5年内,大多数受访者熟悉婴儿单心室试验结果,并报告在单心室婴儿中使用血管紧张素转换酶抑制剂的频率降低;然而,28%的受访者报告未根据试验结果调整其临床决策。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/19b4/5721352/745f721d1113/nihms920005f1.jpg

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