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Purines for Rapid Identification of Stroke Mimics (PRISM): study protocol for a diagnostic accuracy study
BACKGROUND: Rapid treatment of stroke improves outcomes, but accurate early recognition can be challenging. Between 20 and 40% of patients suspected to have stroke by ambulance and emergency department staff later receive a non-stroke ‘mimic’ diagnosis after stroke specialist investigation. This ear...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8134819/ https://www.ncbi.nlm.nih.gov/pubmed/34016192 http://dx.doi.org/10.1186/s41512-021-00098-3 |
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author | Shaw, Lisa Graziadio, Sara Lendrem, Clare Dale, Nicholas Ford, Gary A. Roffe, Christine Smith, Craig J. White, Philip M. Price, Christopher I. |
author_facet | Shaw, Lisa Graziadio, Sara Lendrem, Clare Dale, Nicholas Ford, Gary A. Roffe, Christine Smith, Craig J. White, Philip M. Price, Christopher I. |
author_sort | Shaw, Lisa |
collection | PubMed |
description | BACKGROUND: Rapid treatment of stroke improves outcomes, but accurate early recognition can be challenging. Between 20 and 40% of patients suspected to have stroke by ambulance and emergency department staff later receive a non-stroke ‘mimic’ diagnosis after stroke specialist investigation. This early diagnostic uncertainty results in displacement of mimic patients from more appropriate services, inappropriate demands on stroke specialist resources and delayed access to specialist therapies for stroke patients. Blood purine concentrations rise rapidly during hypoxic tissue injury, which is a key mechanism of damage during acute stroke but is not typical in mimic conditions. A portable point of care fingerprick test has been developed to measure blood purine concentration which could be used to triage patients experiencing suspected stroke symptoms into those likely to have a non-stroke mimic condition and those likely to have true stroke. This study is evaluating test performance for identification of stroke mimic conditions. METHODS: Design: prospective observational cohort study Setting: regional UK ambulance and acute stroke services Participants: a convenience series of two populations will be tested: adults with a label of suspected stroke assigned (and tested) by attending ambulance personnel and adults with a label of suspected stroke assigned at hospital (who have not been tested by ambulance staff). Index test: SMARTChip Purine assay Reference standard tests: expert clinician opinion informed by brain imaging and/or other investigations will assign the following diagnoses which constitute the suspected stroke population: ischaemic stroke, haemorrhagic stroke, TIA and stroke mimic conditions. Sample size: ambulance population (powered for mimic sensitivity) 935 participants; hospital population (powered for mimic specificity) 377 participants. Analyses: area under the receiver operating curve (ROC) and optimal sensitivity, specificity, and negative and positive predictive values for identification of mimic conditions. Optimal threshold for the ambulance population will maximise sensitivity, minimum 80%, and aim to keep specificity above 70%. Optimal threshold for the hospital population will maximise specificity, minimum 80%, and aim to keep sensitivity above 70%. DISCUSSION: The results from this study will determine how accurately the SMARTChip purine assay test can identify stroke mimic conditions within the suspected stroke population. If acceptable performance is confirmed, deployment of the test in ambulances or emergency departments could enable more appropriate direction of patients to stroke or non-stroke services. TRIAL REGISTRATION: Registered with ISRCTN (identifier: ISRCTN22323981) on 13/02/2019 http://www.isrctn.com/ISRCTN22323981 |
format | Online Article Text |
id | pubmed-8134819 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-81348192021-05-20 Purines for Rapid Identification of Stroke Mimics (PRISM): study protocol for a diagnostic accuracy study Shaw, Lisa Graziadio, Sara Lendrem, Clare Dale, Nicholas Ford, Gary A. Roffe, Christine Smith, Craig J. White, Philip M. Price, Christopher I. Diagn Progn Res Protocol BACKGROUND: Rapid treatment of stroke improves outcomes, but accurate early recognition can be challenging. Between 20 and 40% of patients suspected to have stroke by ambulance and emergency department staff later receive a non-stroke ‘mimic’ diagnosis after stroke specialist investigation. This early diagnostic uncertainty results in displacement of mimic patients from more appropriate services, inappropriate demands on stroke specialist resources and delayed access to specialist therapies for stroke patients. Blood purine concentrations rise rapidly during hypoxic tissue injury, which is a key mechanism of damage during acute stroke but is not typical in mimic conditions. A portable point of care fingerprick test has been developed to measure blood purine concentration which could be used to triage patients experiencing suspected stroke symptoms into those likely to have a non-stroke mimic condition and those likely to have true stroke. This study is evaluating test performance for identification of stroke mimic conditions. METHODS: Design: prospective observational cohort study Setting: regional UK ambulance and acute stroke services Participants: a convenience series of two populations will be tested: adults with a label of suspected stroke assigned (and tested) by attending ambulance personnel and adults with a label of suspected stroke assigned at hospital (who have not been tested by ambulance staff). Index test: SMARTChip Purine assay Reference standard tests: expert clinician opinion informed by brain imaging and/or other investigations will assign the following diagnoses which constitute the suspected stroke population: ischaemic stroke, haemorrhagic stroke, TIA and stroke mimic conditions. Sample size: ambulance population (powered for mimic sensitivity) 935 participants; hospital population (powered for mimic specificity) 377 participants. Analyses: area under the receiver operating curve (ROC) and optimal sensitivity, specificity, and negative and positive predictive values for identification of mimic conditions. Optimal threshold for the ambulance population will maximise sensitivity, minimum 80%, and aim to keep specificity above 70%. Optimal threshold for the hospital population will maximise specificity, minimum 80%, and aim to keep sensitivity above 70%. DISCUSSION: The results from this study will determine how accurately the SMARTChip purine assay test can identify stroke mimic conditions within the suspected stroke population. If acceptable performance is confirmed, deployment of the test in ambulances or emergency departments could enable more appropriate direction of patients to stroke or non-stroke services. TRIAL REGISTRATION: Registered with ISRCTN (identifier: ISRCTN22323981) on 13/02/2019 http://www.isrctn.com/ISRCTN22323981 BioMed Central 2021-05-20 /pmc/articles/PMC8134819/ /pubmed/34016192 http://dx.doi.org/10.1186/s41512-021-00098-3 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Protocol Shaw, Lisa Graziadio, Sara Lendrem, Clare Dale, Nicholas Ford, Gary A. Roffe, Christine Smith, Craig J. White, Philip M. Price, Christopher I. Purines for Rapid Identification of Stroke Mimics (PRISM): study protocol for a diagnostic accuracy study |
title | Purines for Rapid Identification of Stroke Mimics (PRISM): study protocol for a diagnostic accuracy study |
title_full | Purines for Rapid Identification of Stroke Mimics (PRISM): study protocol for a diagnostic accuracy study |
title_fullStr | Purines for Rapid Identification of Stroke Mimics (PRISM): study protocol for a diagnostic accuracy study |
title_full_unstemmed | Purines for Rapid Identification of Stroke Mimics (PRISM): study protocol for a diagnostic accuracy study |
title_short | Purines for Rapid Identification of Stroke Mimics (PRISM): study protocol for a diagnostic accuracy study |
title_sort | purines for rapid identification of stroke mimics (prism): study protocol for a diagnostic accuracy study |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8134819/ https://www.ncbi.nlm.nih.gov/pubmed/34016192 http://dx.doi.org/10.1186/s41512-021-00098-3 |
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