Reporting on data monitoring committees in neonatal randomised controlled trials is inconsistent

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dc.contributor.author Perrem, L. M.
dc.contributor.author Gosling, S.
dc.contributor.author Ravikumar, I.
dc.contributor.author Khashan, Ali S.
dc.contributor.author Miletin, J.
dc.contributor.author Ryan, C. Anthony
dc.contributor.author Dempsey, Eugene M.
dc.date.accessioned 2016-10-11T11:56:22Z
dc.date.available 2016-10-11T11:56:22Z
dc.date.issued 2016-09-16
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
dc.identifier.issued 1
dc.identifier.startpage 30
dc.identifier.endpage 33
dc.identifier.issn 0803-5253
dc.identifier.uri http://hdl.handle.net/10468/3175
dc.identifier.doi 10.1111/apa.13593
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. en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher John Wiley & Sons, Inc. en
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. en
dc.subject Clinical trials en
dc.subject Randomised controlled trials en
dc.subject RCTs en
dc.subject Data monitoring committees en
dc.subject DMCs en
dc.subject Stopping rules en
dc.subject Interim analysis en
dc.subject Neonatal en
dc.title Reporting on data monitoring committees in neonatal randomised controlled trials is inconsistent en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Eugene Dempsey, Paediatrics and Child Health, University College Cork, Cork, Ireland. +353-21-490-3000 Email: g.dempsey@ucc.ie en
dc.internal.availability Full text available en
dc.check.info Access to this article is restricted until 12 months after publication by request of the publisher. en
dc.check.date 2017-09-16
dc.description.version Accepted Version en
dc.internal.rssid 395506581
dc.description.status Peer reviewed en
dc.identifier.journaltitle Acta Paediatrica en
dc.internal.IRISemailaddress g.dempsey@ucc.ie
dc.internal.IRISemailaddress g.dempsey@ucc.ie en


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