Adverse event reporting and trial registration in venous leg ulcer trials published since the 2001 CONSORT statement revision: A systematic review.

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dc.contributor.author Jull, Andrew en
dc.contributor.author Biggs, Rowan en
dc.date.accessioned 2019-11-25T21:32:08Z en
dc.date.issued 2020-08 en
dc.identifier.citation Journal of Tissue Viability 01 Jan 2019 en
dc.identifier.issn 0965-206X en
dc.identifier.uri http://hdl.handle.net/2292/49194 en
dc.description.abstract AIM:To be in accord with the Consolidated Standards of Reporting Trials (CONSORT) Statement, all important adverse events in randomised controlled trials (RCTs) should be reported, as well as trial registration. Neither concern has been investigated in venous leg ulcer trials. We therefore aimed to quantify and explore compliance with adverse event reporting and trials registration in RCTs that reported interventions for treating venous leg ulceration. MATERIALS AND METHODS:We searched the Cochrane Controlled Trials Register, Medline, Embase, and CINAHL for studies reported between 2001 and 2017. Included studies must have been described as randomised controlled trials evaluating any intervention in a VLU population. Data was then extracted by one author into a standard form and checked by a second author. RESULTS:We screened 3100 titles and identified 204 trials involving pharmaceuticals (82), medicated and non-medicated devices (102), organisational (5) or other interventions (15) published in 76 journals. Eighty-four trials reported adverse events (41.2%), while 18 reported no events occurred (8.8%) and 78 did not report adverse events (38.2%). Types of adverse events reported included all-cause (20.1%), ulcer-related only (38.2%), treatment-related only (11.3%) and serious adverse events only (1.0%). Only 38 trials were registered (18.6%). Trial registration was associated with reporting of any adverse events (Odds Ratio 3.0, 95%CI 1.1-7.9), as was the trial being a pharmaceutical trial (Odds Ratio 2.9, 95%CI 1.5-5.7) or a multicentre trial (Odds Ratio 4.2, 95%CI 2.2-8.1). CONCLUSION:Adverse event reporting in VLU trials is variable with about one third of trials not reporting on adverse events at all. Trials registration is a the modifiable factor associated with better reporting of adverse events. Journal editors could explore how they can promote trials registration to enhance better reporting of harms in VLU trials. en
dc.format.medium Print-Electronic en
dc.language eng en
dc.relation.ispartofseries Journal of tissue viability en
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. en
dc.rights.uri https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm en
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/ en
dc.title Adverse event reporting and trial registration in venous leg ulcer trials published since the 2001 CONSORT statement revision: A systematic review. en
dc.type Journal Article en
dc.identifier.doi 10.1016/j.jtv.2019.09.005 en
pubs.issue 3 en
pubs.begin-page 155 en
pubs.volume 29 en
dc.rights.holder Copyright: Published by Elsevier Ltd on behalf of Tissue Viability Society en
pubs.end-page 160 en
pubs.publication-status Published en
dc.rights.accessrights http://purl.org/eprint/accessRights/OpenAccess en
pubs.subtype Review en
pubs.subtype Journal Article en
pubs.elements-id 783921 en
pubs.org-id Medical and Health Sciences en
pubs.org-id Nursing en
pubs.record-created-at-source-date 2019-10-08 en
pubs.dimensions-id 31587922 en


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