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Do outcomes reported in randomised controlled trials of joint replacement surgery fulfil the OMERACT 2.0 Filter? A review of the 2008 and 2013 literature.
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Wall, Peter D. H., Richards, Bethan L., Sprowson, Andrew P., Buchbinder, Rachelle and Singh, Jasvinder A. (2017) Do outcomes reported in randomised controlled trials of joint replacement surgery fulfil the OMERACT 2.0 Filter? A review of the 2008 and 2013 literature. Systematic Reviews, 6 (1). 106. doi:10.1186/s13643-017-0498-3 ISSN 2046-4053.
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Official URL: http://dx.doi.org/10.1186/s13643-017-0498-3
Abstract
Background
It is not known, whether outcome reporting in trials of total joint arthroplasty in the recent years is adequate or not. Our objective was to assess whether outcomes reported in total joint replacement (TJR) trials fulfil the Outcome Measures in Rheumatology (OMERACT) Filter 2.0.
Methods
We systematically reviewed all TJR trials in adults, published in English in 2008 or 2013. Searches were conducted in the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE. Two authors independently applied the inclusion criteria for the studies, and any disagreement was resolved with a third review author. All outcome measures were abstracted using a pre-piloted standardised data extraction form and assessed for whether they mapped to one of the three OMERACT Filter 2.0 core areas: pathophysiological, life impact, and death.
Results
From 1635 trials identified, we included 70 trials (30 in 2008 and 40 in 2013) meeting the eligibility criteria. Twenty-two (31%) trials reported the three essential OMERACT core areas. Among the 27 hip replacement surgery trials and 39 knee replacement surgery trials included, 11 hip (41%) and nine knee (23%) trials reported all three essential OMERACT core areas. The most common outcome domains/measures were pain (20/27, 74%) and function (23/27, 85%) in hip trials and pain (26/39, 67%) and function (27/39, 69%) in knee trials. Results were similar for shoulder and hand joint replacement trials.
Conclusions
We identified significant gaps in the measurement of OMERACT core outcome areas in TJR trials, despite the majority reporting outcome domains of pain and function. An international consensus of key stakeholders is needed to develop a core domain set for reporting of TJR trials.
Item Type: | Journal Article | ||||||||||||
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Subjects: | R Medicine > RD Surgery | ||||||||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Library of Congress Subject Headings (LCSH): | Arthroplasty, Outcome assessment (Medical care), Joints -- Surgery -- Statistics, Rheumatoid arthritis -- Treament, Systematic reviews (Medical research), Clinical trials, Artificial joints | ||||||||||||
Journal or Publication Title: | Systematic Reviews | ||||||||||||
Publisher: | BioMed Central Ltd. | ||||||||||||
ISSN: | 2046-4053 | ||||||||||||
Official Date: | 30 May 2017 | ||||||||||||
Dates: |
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Volume: | 6 | ||||||||||||
Number: | 1 | ||||||||||||
Article Number: | 106 | ||||||||||||
DOI: | 10.1186/s13643-017-0498-3 | ||||||||||||
Status: | Peer Reviewed | ||||||||||||
Publication Status: | Published | ||||||||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||||||||
RIOXX Funder/Project Grant: |
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