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dc.contributor.authorCarlton, E
dc.contributor.authorCampbell, S
dc.contributor.authorIngram, J
dc.contributor.authorKandiyali, R
dc.contributor.authorTaylor, H
dc.contributor.authorAziz, S
dc.contributor.authorBeresford, P
dc.contributor.authorKendall, J
dc.contributor.authorReuben, A
dc.contributor.authorZhu, Chengyong
dc.contributor.authorVickery, Jane
dc.contributor.authorBenger, JR
dc.date.accessioned2021-09-28T10:52:28Z
dc.date.issued2018-10-02
dc.identifier.issn2044-6055
dc.identifier.issn2044-6055
dc.identifier.otherARTN e025339
dc.identifier.urihttp://hdl.handle.net/10026.1/17966
dc.description.abstract

<jats:sec><jats:title>Introduction</jats:title><jats:p>Observational data suggest a single high-sensitivity troponin blood test taken at emergency department (ED) presentation could be used to rule out major adverse cardiac events (MACE) in 10%–60% of ED patients with chest pain. This is done using an ‘undetectable’ cut-off (the Limit of Detection: LoD). We combined the LoD cut-off with ECG findings to create the LoDED strategy. We aim to establish whether the LoDED strategy works under real-life conditions, when compared with existing strategies, in a way that is cost-effective and acceptable to patients.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>This is a parallel-group pragmatic randomised controlled trial across UK EDs. Adults presenting to ED with suspected cardiac chest pain will be randomised 1:1. Existing rule-out strategies in current use across study centres, using serial high-sensitivity troponin testing, will be compared with the LoDED strategy. The primary outcome is successful early discharge (discharge from hospital within 4 hours of arrival) without MACE occurring within 30 days. Secondary outcomes include initial length of hospital stay; comparative costs; patient satisfaction and acceptability to patients. To detect a 9% difference between the early discharge rates (assuming an 8% rate in the standard care group) with 90% power, 594 patients need to be recruited, assuming a 95% follow-up rate.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>The study has been approved by the Frenchay Research Ethics Committee (reference 18/SW/0038). Results will be published in an international peer-reviewed journal. Lay summaries will be made available to patients.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="ISRCTN86184521" ext-link-type="isrctn" specific-use="clinicaltrial pre-results">ISRCTN86184521</jats:ext-link>; Pre-results.</jats:p></jats:sec>

dc.format.extente025339-e025339
dc.format.mediumElectronic
dc.languageen
dc.language.isoen
dc.publisherBMJ Publishing Group
dc.subjectcardiology
dc.subjectclinical chemistry
dc.subjecthealth economics
dc.subjectischaemic heart disease
dc.subjectmyocardial infarction
dc.subjectBiomarkers
dc.subjectChest Pain
dc.subjectCost-Benefit Analysis
dc.subjectElectrocardiography
dc.subjectEmergency Service, Hospital
dc.subjectHospital Costs
dc.subjectHumans
dc.subjectLength of Stay
dc.subjectLimit of Detection
dc.subjectMulticenter Studies as Topic
dc.subjectMyocardial Infarction
dc.subjectPragmatic Clinical Trials as Topic
dc.subjectRisk Assessment
dc.subjectRisk Factors
dc.subjectTroponin
dc.titleRandomised controlled trial of the Limit of Detection of Troponin and ECG Discharge (LoDED) strategy versus usual care in adult patients with chest pain attending the emergency department: study protocol
dc.typejournal-article
dc.typeClinical Trial Protocol
dc.typeJournal Article
dc.typeResearch Support, Non-U.S. Gov't
plymouth.author-urlhttp://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000454739500191&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008
plymouth.issue10
plymouth.volume8
plymouth.publication-statusPublished
plymouth.journalBMJ Open
dc.identifier.doi10.1136/bmjopen-2018-025339
plymouth.organisational-group/Plymouth
plymouth.organisational-group/Plymouth/Faculty of Health
plymouth.organisational-group/Plymouth/Research Groups
plymouth.organisational-group/Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)
plymouth.organisational-group/Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CCT&PS
dc.publisher.placeEngland
dcterms.dateAccepted2018-08-07
dc.rights.embargodate2021-9-29
dc.identifier.eissn2044-6055
dc.rights.embargoperiodNot known
rioxxterms.versionofrecord10.1136/bmjopen-2018-025339
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2018-10-02
rioxxterms.typeJournal Article/Review


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