dc.contributor.author |
Duffy, JMN |
en |
dc.contributor.author |
Hirsch, M |
en |
dc.contributor.author |
Pealing, L |
en |
dc.contributor.author |
Showell, Marian |
en |
dc.contributor.author |
Khan, KS |
en |
dc.contributor.author |
Ziebland, S |
en |
dc.contributor.author |
McManus, RJ |
en |
dc.contributor.author |
International Collaboration to Harmonise Outcomes in Pre-eclampsia (iHOPE) |
en |
dc.date.accessioned |
2018-11-15T02:30:55Z |
en |
dc.date.issued |
2018-06 |
en |
dc.identifier.citation |
BJOG: An International Journal of Obstetrics and Gynaecology 125(7):795-803 Jun 2018 |
en |
dc.identifier.issn |
1470-0328 |
en |
dc.identifier.uri |
http://hdl.handle.net/2292/44303 |
en |
dc.description.abstract |
BACKGROUND:Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions. OBJECTIVE:To assess safety reporting in pre-eclampsia trials. SEARCH STRATEGY:Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017. SELECTION CRITERIA:Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia. DATA COLLECTION AND ANALYSIS:Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting. MAIN RESULTS:We included 60 randomised trials. Six trials (10%) were registered with the International Clinical Trials Registry Platform, two registry records referred to adverse reactions, stating 'safety and toleration' and 'possible side effects' would be collected. Twenty-six trials (43%) stated the frequency of withdrawals within each study arm, and five trials (8%) adequately reported these withdrawals. Adverse reactions were inconsistently reported across eligible trials: 24 (40%) reported no serious adverse reactions and 36 (60%) reported no mild adverse reactions. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports. CONCLUSIONS:Pre-eclampsia trials regularly omit critical information related to safety. Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms. FUNDING:National Institute for Health Research (DRF-2014-07-051), UK; Maternity Forum, Royal Society of Medicine, UK. TWEETABLE ABSTRACT:Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC. |
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dc.publisher |
Wiley |
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dc.relation.ispartofseries |
BJOG: An International Journal of Obstetrics and Gynaecology |
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dc.rights |
Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. |
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dc.rights |
This is the peer reviewed version of the following article: BJOG: An International Journal of Obstetrics and Gynaecology 125(7):795-803 Jun 2018, which has been published in final form at http://dx.doi.org/10.1111/1471-0528.14969 This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. |
en |
dc.rights.uri |
https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm |
en |
dc.rights.uri |
https://authorservices.wiley.com/author-resources/Journal-Authors/licensing/self-archiving.html |
en |
dc.title |
Inadequate safety reporting in pre-eclampsia trials. A systematic evaluation |
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dc.type |
Journal Article |
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dc.identifier.doi |
10.1111/1471-0528.14969 |
en |
pubs.issue |
7 |
en |
pubs.begin-page |
795 |
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pubs.volume |
125 |
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dc.rights.holder |
Copyright: Royal College of Obstetricians and Gynaecologists |
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dc.identifier.pmid |
29030992 |
en |
pubs.end-page |
803 |
en |
dc.rights.accessrights |
http://purl.org/eprint/accessRights/OpenAccess |
en |
pubs.subtype |
Review |
en |
pubs.elements-id |
694658 |
en |
pubs.org-id |
Medical and Health Sciences |
en |
pubs.org-id |
School of Medicine |
en |
pubs.org-id |
Obstetrics and Gynaecology |
en |
dc.identifier.eissn |
1471-0528 |
en |
pubs.record-created-at-source-date |
2017-10-17 |
en |
pubs.dimensions-id |
29030992 |
en |