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. Carlton, E., Campbell, S., Ingram, J., Kandiyali, R., Taylor, H., Aziz, S., Beresford, P., Kendall, J., Reuben, A., Smith, J., Vickery, P. J., & Benger, J. R. BMJ Open, 8(10):e025339, October, 2018.
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 [link]Paper  doi  abstract   bibtex   
Introduction 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. Methods and analysis 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. Ethics and dissemination 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. Trial registration number ISRCTN86184521; Pre-results.
@article{carlton_randomised_2018,
	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},
	volume = {8},
	copyright = {© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ.. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.},
	issn = {2044-6055, 2044-6055},
	shorttitle = {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},
	url = {https://bmjopen.bmj.com/content/8/10/e025339},
	doi = {10.1136/bmjopen-2018-025339},
	abstract = {Introduction 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.
Methods and analysis 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.
Ethics and dissemination 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.
Trial registration number ISRCTN86184521; Pre-results.},
	language = {en},
	number = {10},
	urldate = {2018-10-03TZ},
	journal = {BMJ Open},
	author = {Carlton, Edward and Campbell, Sarah and Ingram, Jenny and Kandiyali, Rebecca and Taylor, Hazel and Aziz, Shahid and Beresford, Peter and Kendall, Jason and Reuben, Adam and Smith, Jason and Vickery, Patricia Jane and Benger, Jonathan Richard},
	month = oct,
	year = {2018},
	keywords = {\_tablet, cardiology, clinical chemistry, health economics, ischaemic heart disease, myocardial infarction},
	pages = {e025339}
}
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