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

Simple item page
dc.check.date2017-09-16
dc.check.infoAccess to this article is restricted until 12 months after publication by request of the publisher.en
dc.contributor.authorPerrem, L. M.
dc.contributor.authorGosling, S.
dc.contributor.authorRavikumar, I.
dc.contributor.authorKhashan, Ali S.
dc.contributor.authorMiletin, J.
dc.contributor.authorRyan, C. Anthony
dc.contributor.authorDempsey, Eugene M.
dc.date.accessioned2016-10-11T11:56:22Z
dc.date.available2016-10-11T11:56:22Z
dc.date.issued2016-09-16
dc.description.abstractAim: 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.description.statusPeer revieweden
dc.description.versionAccepted Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationPerrem, 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.13593en
dc.identifier.doi10.1111/apa.13593
dc.identifier.endpage33
dc.identifier.issn0803-5253
dc.identifier.issued1
dc.identifier.journaltitleActa Paediatricaen
dc.identifier.startpage30
dc.identifier.urihttps://hdl.handle.net/10468/3175
dc.identifier.volume106
dc.language.isoenen
dc.publisherJohn 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.subjectClinical trialsen
dc.subjectRandomised controlled trialsen
dc.subjectRCTsen
dc.subjectData monitoring committeesen
dc.subjectDMCsen
dc.subjectStopping rulesen
dc.subjectInterim analysisen
dc.subjectNeonatalen
dc.titleReporting on data monitoring committees in neonatal randomised controlled trials is inconsistenten
dc.typeArticle (peer-reviewed)en
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
1254.pdf
Size:
101.92 KB
Format:
Adobe Portable Document Format
Description:
Accepted Version
Download
License bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
license.txt
Size:
2.71 KB
Format:
Item-specific license agreed upon to submission
Description:
Download
Collections
Paediatrics and Child Health - Journal Articles
Public Health - Journal Articles