Randomised 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.contributor.author | Carlton, E | |
dc.contributor.author | Campbell, S | |
dc.contributor.author | Ingram, J | |
dc.contributor.author | Kandiyali, R | |
dc.contributor.author | Taylor, H | |
dc.contributor.author | Aziz, S | |
dc.contributor.author | Beresford, P | |
dc.contributor.author | Kendall, J | |
dc.contributor.author | Reuben, A | |
dc.contributor.author | Zhu, Chengyong | |
dc.contributor.author | Vickery, Jane | |
dc.contributor.author | Benger, JR | |
dc.date.accessioned | 2021-09-28T10:52:28Z | |
dc.date.issued | 2018-10-02 | |
dc.identifier.issn | 2044-6055 | |
dc.identifier.issn | 2044-6055 | |
dc.identifier.other | ARTN e025339 | |
dc.identifier.uri | http://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.extent | e025339-e025339 | |
dc.format.medium | Electronic | |
dc.language | en | |
dc.language.iso | en | |
dc.publisher | BMJ Publishing Group | |
dc.subject | cardiology | |
dc.subject | clinical chemistry | |
dc.subject | health economics | |
dc.subject | ischaemic heart disease | |
dc.subject | myocardial infarction | |
dc.subject | Biomarkers | |
dc.subject | Chest Pain | |
dc.subject | Cost-Benefit Analysis | |
dc.subject | Electrocardiography | |
dc.subject | Emergency Service, Hospital | |
dc.subject | Hospital Costs | |
dc.subject | Humans | |
dc.subject | Length of Stay | |
dc.subject | Limit of Detection | |
dc.subject | Multicenter Studies as Topic | |
dc.subject | Myocardial Infarction | |
dc.subject | Pragmatic Clinical Trials as Topic | |
dc.subject | Risk Assessment | |
dc.subject | Risk Factors | |
dc.subject | Troponin | |
dc.title | Randomised 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.type | journal-article | |
dc.type | Clinical Trial Protocol | |
dc.type | Journal Article | |
dc.type | Research Support, Non-U.S. Gov't | |
plymouth.author-url | http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000454739500191&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008 | |
plymouth.issue | 10 | |
plymouth.volume | 8 | |
plymouth.publication-status | Published | |
plymouth.journal | BMJ Open | |
dc.identifier.doi | 10.1136/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.place | England | |
dcterms.dateAccepted | 2018-08-07 | |
dc.rights.embargodate | 2021-9-29 | |
dc.identifier.eissn | 2044-6055 | |
dc.rights.embargoperiod | Not known | |
rioxxterms.versionofrecord | 10.1136/bmjopen-2018-025339 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2018-10-02 | |
rioxxterms.type | Journal Article/Review |