dc.contributor.author |
Perrem, L. M. |
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dc.contributor.author |
Gosling, S. |
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dc.contributor.author |
Ravikumar, I. |
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dc.contributor.author |
Khashan, Ali S. |
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dc.contributor.author |
Miletin, J. |
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dc.contributor.author |
Ryan, C. Anthony |
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dc.contributor.author |
Dempsey, Eugene M. |
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dc.date.accessioned |
2016-10-11T11:56:22Z |
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dc.date.available |
2016-10-11T11:56:22Z |
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dc.date.issued |
2016-09-16 |
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dc.identifier.citation |
Perrem, L. M., Gosling, S., Ravikumar, I., Khashan, A. S., Miletin, J., Ryan, C. A. and Dempsey, E. (2016) 'Reporting on data monitoring committees in neonatal randomised controlled trials is inconsistent', Acta Paediatrica, 106(1), pp. 30-33. doi: 10.1111/apa.13593 |
en |
dc.identifier.volume |
106 |
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dc.identifier.issued |
1 |
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dc.identifier.startpage |
30 |
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dc.identifier.endpage |
33 |
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dc.identifier.issn |
0803-5253 |
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dc.identifier.uri |
http://hdl.handle.net/10468/3175 |
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dc.identifier.doi |
10.1111/apa.13593 |
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dc.description.abstract |
Aim: To evaluate the reported use of Data Monitoring Committees (DMCs), the frequency of interim analysis, pre-specified stopping rules and early trial termination in neonatal randomised controlled trials (RCTs). Methods: We reviewed neonatal RCTs published in four high impact general medical journals, specifically looking at safety issues including documented involvement of a DMC, stated interim analysis, stopping rules and early trial termination. We searched all journal issues over an 11-year period (2003-2013) and recorded predefined parameters on each item for RCTs meeting inclusion criteria. Results: Seventy neonatal trials were identified in four general medical journals: Lancet, New England Journal of Medicine (NEJM), British Medical Journal and Journal of American Medical Association (JAMA). 43 (61.4%) studies reported the presence of a DMC, 36 (51.4%) explicitly mentioned interim analysis; stopping rules were reported in 15 (21.4%) RCTs and 7 (10%) trials were terminated early. The NEJM most frequently reported these parameters compared to the other three journals reviewed. Conclusion: While the majority of neonatal RCTs report on DMC involvement and interim analysis there is still scope for improvement. Clear documentation of safety related issues should be a central component of reporting in neonatal trials involving newborn infants. |
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dc.format.mimetype |
application/pdf |
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dc.language.iso |
en |
en |
dc.publisher |
John Wiley & Sons, Inc. |
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dc.rights |
© 2016, John Wiley & Sons, Inc. This is the peer reviewed version of the following article: Perrem, L.M., Gosling, S., Ravikumar, I., Khashan, A.S., Miletin, J., Ryan, C.A. and Dempsey, E. (2016) 'Reporting on Data Monitoring Committees in neonatal Randomised Controlled Trials is inconsistent', Acta Paediatrica, which has been published in final form at http://dx.doi.org/10.1111/apa.13593. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving. |
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dc.subject |
Clinical trials |
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dc.subject |
Randomised controlled trials |
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dc.subject |
RCTs |
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dc.subject |
Data monitoring committees |
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dc.subject |
DMCs |
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dc.subject |
Stopping rules |
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dc.subject |
Interim analysis |
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dc.subject |
Neonatal |
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dc.title |
Reporting on data monitoring committees in neonatal randomised controlled trials is inconsistent |
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dc.type |
Article (peer-reviewed) |
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dc.internal.authorcontactother |
Eugene Dempsey, Paediatrics and Child Health, University College Cork, Cork, Ireland. +353-21-490-3000 Email: g.dempsey@ucc.ie |
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dc.internal.availability |
Full text available |
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dc.check.info |
Access to this article is restricted until 12 months after publication by request of the publisher. |
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dc.check.date |
2017-09-16 |
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dc.description.version |
Accepted Version |
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dc.internal.rssid |
395506581 |
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dc.description.status |
Peer reviewed |
en |
dc.identifier.journaltitle |
Acta Paediatrica |
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dc.internal.IRISemailaddress |
g.dempsey@ucc.ie |
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dc.internal.IRISemailaddress |
g.dempsey@ucc.ie |
en |