Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3
World
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3
World
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
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Alper: </p><p><b>publisher</b>: Computable Publishing LLC</p><p><b>contact</b>: <a href=\"mailto:support@computablepublishing.com\">support@computablepublishing.com</a></p><p><b>description</b>: </p><div><p>A preprint for combination of 3 adaptive RCTs</p>\n</div><h3>UseContexts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"http://terminology.hl7.org/7.3.0/CodeSystem-usage-context-type.html#usage-context-type-program\">UsageContextType: program</a> (Program)</td><td><span title=\"Codes:\">EBMonFHIR/COKA Demonstration</span></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"http://terminology.hl7.org/7.3.0/CodeSystem-citation-classification-type.html#citation-classification-type-fevir-platform-use\">Citation Classification Type: fevir-platform-use</a> (FEvIR Platform Use)</td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/citation-artifact-classifier project-specific}\">Project Specific</span></td></tr></table><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>\n</div><h3>Summaries</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Style</b></td><td><b>Text</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/citation-summary-style comppub}\">Computable Publishing</span></td><td><div><p>Therapeutic Anticoagulation in Non-Critically Ill Patients with Covid-19 [Preprint], version v1. Contributors: The ATTACC, ACTIV-4a, and REMAP-CAP Investigators, Patrick R. Lawler, Ewan C. Goligher, Jeffrey S. Berger, Matthew D. Neal, Bryan J. McVerry, Jose C. Nicolau, Michelle N. Gong, Marc Carrier, Robert S. Rosenson, Harmony R. Reynolds, Alexis F. Turgeon, Jorge Escobedo, David T. Huang, Charlotte Ann Bradbury, Brett L. Houston, Lucy Z. Kornblith, Anand Kumar, Susan R. Kahn, Mary Cushman, Zoe McQuilten, Arthur S. Slutsky, Keri S. Kim, Anthony C. Gordon, Bridget-Anne Kirwan, Maria M. Brooks, Alisa M. Higgins, Roger J. Lewis, Elizabeth Lorenzi, Scott M. Berry, Lindsay R. Berry, Derek C. Angus, Colin J. McArthur, Steven A. Webb, Michael E. Farkouh, Judith S. Hochman, Ryan Zarychanski. In: medRxiv, DOI 10.1101/2021.05.13.21256846. Published May 17, 2021. Accessed July 16, 2021. Available at: https://doi.org/10.1101/2021.05.13.21256846.</p>\n</div></td></tr></table><h3>Classifications</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/citation-classification-type fevir-platform-use}\">FEvIR Platform Use</span></td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/citation-artifact-classifier project-specific}\">Project Specific</span></td></tr></table><blockquote><p><b>citedArtifact</b></p><p><b>identifier</b>: <code>https://doi.org</code>/10.1101/2021.05.13.21256846</p><p><b>relatedIdentifier</b>: <a href=\"http://terminology.hl7.org/7.3.0/NamingSystem-ClinicalTrialsGov.html\" title=\"RETIREMENT INFO: This entry was incorrectly added as a code system record, however, ClinicalTrials.gov is an identifier system. That entry should be referenced instead at [https://terminology.hl7.org/NamingSystem-ClinicalTrials-Gov.html](https://terminology.hl7.org/NamingSystem-ClinicalTrials-Gov.html).\r\n\r\nThe U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed [ClinicalTrials.gov](http://clinicaltrials.gov) to provide patients, family members, and members of the public current information about clinical research studies. [ClinicalTrials.gov](http://clinicaltrials.gov) contains summary information about clinical studies being conducted throughout the United States and in many countries throughout the world. These data are provided to the National Library of Medicine by organizations and institutions that sponsor and implement the studies.\r\n\r\n[ClinicalTrials.gov](http://clinicaltrials.gov) is updated daily. 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[ClinicalTrials.gov](http://clinicaltrials.gov) contains summary information about clinical studies being conducted throughout the United States and in many countries throughout the world. These data are provided to the National Library of Medicine by organizations and institutions that sponsor and implement the studies.\r\n\r\n[ClinicalTrials.gov](http://clinicaltrials.gov) is updated daily. You should check [ClinicalTrials.gov](http://clinicaltrials.gov) frequently for updated information.\r\n\r\nMore information about ClinicalTrials.gov can be found [here](https://clinicaltrials.gov/about-site/about-ctg).\">ClinicalTrials.gov</a>/NCT04505774, <a href=\"http://terminology.hl7.org/7.3.0/NamingSystem-ClinicalTrialsGov.html\" title=\"RETIREMENT INFO: This entry was incorrectly added as a code system record, however, ClinicalTrials.gov is an identifier system. That entry should be referenced instead at [https://terminology.hl7.org/NamingSystem-ClinicalTrials-Gov.html](https://terminology.hl7.org/NamingSystem-ClinicalTrials-Gov.html).\r\n\r\nThe U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed [ClinicalTrials.gov](http://clinicaltrials.gov) to provide patients, family members, and members of the public current information about clinical research studies. [ClinicalTrials.gov](http://clinicaltrials.gov) contains summary information about clinical studies being conducted throughout the United States and in many countries throughout the world. These data are provided to the National Library of Medicine by organizations and institutions that sponsor and implement the studies.\r\n\r\n[ClinicalTrials.gov](http://clinicaltrials.gov) is updated daily. You should check [ClinicalTrials.gov](http://clinicaltrials.gov) frequently for updated information.\r\n\r\nMore information about ClinicalTrials.gov can be found [here](https://clinicaltrials.gov/about-site/about-ctg).\">ClinicalTrials.gov</a>/NCT04359277, <a href=\"http://terminology.hl7.org/7.3.0/NamingSystem-ClinicalTrialsGov.html\" title=\"RETIREMENT INFO: This entry was incorrectly added as a code system record, however, ClinicalTrials.gov is an identifier system. That entry should be referenced instead at [https://terminology.hl7.org/NamingSystem-ClinicalTrials-Gov.html](https://terminology.hl7.org/NamingSystem-ClinicalTrials-Gov.html).\r\n\r\nThe U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed [ClinicalTrials.gov](http://clinicaltrials.gov) to provide patients, family members, and members of the public current information about clinical research studies. [ClinicalTrials.gov](http://clinicaltrials.gov) contains summary information about clinical studies being conducted throughout the United States and in many countries throughout the world. These data are provided to the National Library of Medicine by organizations and institutions that sponsor and implement the studies.\r\n\r\n[ClinicalTrials.gov](http://clinicaltrials.gov) is updated daily. You should check [ClinicalTrials.gov](http://clinicaltrials.gov) frequently for updated information.\r\n\r\nMore information about ClinicalTrials.gov can be found [here](https://clinicaltrials.gov/about-site/about-ctg).\">ClinicalTrials.gov</a>/NCT04372589</p><p><b>dateAccessed</b>: 2021-07-16</p><p><b>version</b>: v1</p><h3>StatusDates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Activity</b></td><td><b>Actual</b></td><td><b>Period</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Posted</span></td><td>true</td><td>2021-05-17 --> (ongoing)</td></tr></table><blockquote><p><b>title</b></p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/title-type primary}\">Primary title</span></p><p><b>language</b>: English</p><p><b>text</b>: </p><div><p>Therapeutic Anticoagulation in Non-Critically Ill Patients with Covid-19</p>\n</div></blockquote><blockquote><p><b>title</b></p><p><b>type</b>: <span title=\"Codes:\">Title used in Supplement</span></p><p><b>language</b>: English</p><p><b>text</b>: </p><div><p>Multi-Platform Randomized Controlled Trial (mpRCT) Therapeutic anticoagulation in patients with moderate\nCovid-19</p>\n</div></blockquote><h3>Abstracts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Language</b></td><td><b>Text</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-abstract-type primary-human-use}\">Primary human use</span></td><td>English</td><td><div><p>Background Thrombo-inflammation may contribute to morbidity and mortality in Covid-19. We hypothesized that therapeutic-dose anticoagulation may improve outcomes in non-critically ill patients hospitalized for Covid-19.</p>\n<p>Methods In an open-label adaptive multiplatform randomized controlled trial, non-critically ill patients hospitalized for Covid-19, defined by the absence of critical care-level organ support at enrollment, were randomized to a pragmatic strategy of therapeutic-dose anticoagulation with heparin or usual care pharmacological thromboprophylaxis. The primary outcome combined survival to hospital discharge and days free of organ support through 21 days, which was evaluated with Bayesian statistical models according to baseline D-dimer.</p>\n<p>Results The trial was stopped when prespecified criteria for superiority were met for therapeutic-dose anticoagulation in groups defined by high (≥2-fold elevated) and low (<2-fold elevated) D-dimer. Among 2219 participants in the final analysis, the probability that therapeutic anticoagulation increased organ support-free days compared to thromboprophylaxis was 99.0% (adjusted odds ratio 1.29, 95% credible interval 1.04 to 1.61). The adjusted absolute increase in survival to hospital discharge without organ support with therapeutic-dose anticoagulation was 4.6% (95% credible interval 0.7 to 8.1). In the primary adaptive stopping groups, the final probabilities of superiority for therapeutic anticoagulation were 97.3% in the high D-dimer group and 92.9% in the low D-dimer group. Major bleeding occurred in 1.9% and 0.9% of participants randomized to therapeutic anticoagulation and thromboprophylaxis, respectively.</p>\n<p>Conclusions In non-critically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increases the probability of survival to hospital discharge with reduced use of organ support.</p>\n</div></td></tr></table><h3>RelatesTos</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Classifier</b></td><td><b>Display</b></td><td><b>Target[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/artifact-relationship-type replaced-with}\">Replaced With</span></td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/citation-artifact-classifier D016428}\">Journal Article</span></td><td>Anticoagulation for COVID-19 Combined RCTs in NEJM</td><td><a href=\"PublicationRecord-7636.html\">PublicationRecord Anticoagulation for COVID-19 Combined RCTs in NEJM</a></td></tr></table><blockquote><p><b>publicationForm</b></p><h3>PublishedIns</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Title</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/published-in-type D019991}\">Database</span></td><td>medRxiv</td></tr></table><p><b>articleDate</b>: 2021-05-17</p><p><b>language</b>: English</p><p><b>pageCount</b>: 32 pages</p></blockquote><blockquote><p><b>webLocation</b></p><p><b>classifier</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/artifact-url-classifier doi-based}\">DOI Based</span></p><p><b>url</b>: <a href=\"https://doi.org/10.1101/2021.05.13.21256846\">https://doi.org/10.1101/2021.05.13.21256846</a></p></blockquote><blockquote><p><b>webLocation</b></p><p><b>classifier</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/artifact-url-classifier full-text}\">Full-Text</span></p><p><b>url</b>: <a href=\"https://www.medrxiv.org/content/10.1101/2021.05.13.21256846v1.full-text\">https://www.medrxiv.org/content/10.1101/2021.05.13.21256846v1.full-text</a></p></blockquote><blockquote><p><b>webLocation</b></p><p><b>classifier</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/artifact-url-classifier supplement}\">Supplement</span></p><p><b>url</b>: <a href=\"https://www.medrxiv.org/content/10.1101/2021.05.13.21256846v1.supplementary-material\">https://www.medrxiv.org/content/10.1101/2021.05.13.21256846v1.supplementary-material</a></p></blockquote><blockquote><p><b>webLocation</b></p><p><b>classifier</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/artifact-url-classifier supplement}, {http://terminology.hl7.org/CodeSystem/artifact-url-classifier pdf}\">Supplement</span></p><p><b>url</b>: <a href=\"https://www.medrxiv.org/content/medrxiv/early/2021/05/17/2021.05.13.21256846/DC1/embed/media-1.pdf?download=true\">https://www.medrxiv.org/content/medrxiv/early/2021/05/17/2021.05.13.21256846/DC1/embed/media-1.pdf?download=true</a></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-classification-type knowledge-artifact-type}\">Knowledge Artifact Type</span></p><p><b>classifier</b>: <span title=\"Codes:\">Preprint</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title=\"Codes:\">Subject Area</span></p><p><b>classifier</b>: <span title=\"Codes:\">Intensive Care and Critical Care Medicine</span></p></blockquote><blockquote><p><b>contributorship</b></p><blockquote><p><b>summary</b></p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/contributor-summary-type author-string}\">Author string</span></p><p><b>source</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/contributor-summary-source article-copy}\">Copied from article</span></p><p><b>value</b>: </p><div><p>The ATTACC, ACTIV-4a, and REMAP-CAP Investigators, Patrick R. Lawler, Ewan C. Goligher, Jeffrey S. Berger, Matthew D. Neal, Bryan J. McVerry, Jose C. Nicolau, Michelle N. Gong, Marc Carrier, Robert S. Rosenson, Harmony R. Reynolds, Alexis F. Turgeon, Jorge Escobedo, David T. Huang, Charlotte Ann Bradbury, Brett L. Houston, Lucy Z. Kornblith, Anand Kumar, Susan R. Kahn, Mary Cushman, Zoe McQuilten, Arthur S. Slutsky, Keri S. Kim, Anthony C. Gordon, Bridget-Anne Kirwan, Maria M. Brooks, Alisa M. Higgins, Roger J. Lewis, Elizabeth Lorenzi, Scott M. Berry, Lindsay R. Berry, Derek C. Angus, Colin J. McArthur, Steven A. Webb, Michael E. Farkouh, Judith S. Hochman, Ryan Zarychanski</p>\n</div></blockquote><blockquote><p><b>summary</b></p><p><b>type</b>: <span title=\"Codes:\">Funding Statement</span></p><p><b>source</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/contributor-summary-source article-copy}\">Copied from article</span></p><p><b>value</b>: </p><div><p>REMAP-CAP: Supported by the European Union through FP7-HEALTH-2013-INNOVATION: the Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE) consortium (602525), and Horizon 2020 research and innovation program: the Rapid European Covid-19 Emergency Research response (RECOVER) consortium (101003589) and by the Australian National Health and Medical Research Council (APP1101719), the Health Research Council of New Zealand (16/631), a Canadian Institutes of Health Research Strategy for Patient-Oriented Research Innovative Clinical Trials Program Grant (158584), the U.K. NIHR and the NIHR Imperial Biomedical Research Centre, the Health Research Board of Ireland (CTN 2014-012), the UPMC Learning While Doing Program, the Breast Cancer Research Foundation, the French Ministry of Health (PHRC-20-0147), the Minderoo Foundation, Amgen, Eisai, the Global Coalition for Adaptive Research, and the Wellcome Trust Innovations Project (215522). Dr. Gordon is funded by an NIHR Research Professorship (RP-2015-06-18), and Dr. Shankar-Hari by an NIHR Clinician Scientist Fellowship (CS-2016-16-011). The ATTACC platform was supported by grants from the Canadian Institutes of Health Research, LifeArc Foundation, Thistledown Foundation, Research Manitoba, Ontario Ministry of Health, and the Peter Munk Cardiac Centre. The ACTIV-4a platform was sponsored by the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD and administered through OTA-20-011. Disclaimer: The views expressed in this publication are those of the author(s) and not necessarily those of the National Health Service (UK), the National Institute for Health Research (UK), the Department of Health and Social Care (UK), or of the National Institutes of Health (USA).</p>\n</div></blockquote></blockquote></blockquote></div>"
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"text" : "Background Thrombo-inflammation may contribute to morbidity and mortality in Covid-19. We hypothesized that therapeutic-dose anticoagulation may improve outcomes in non-critically ill patients hospitalized for Covid-19.\n\nMethods In an open-label adaptive multiplatform randomized controlled trial, non-critically ill patients hospitalized for Covid-19, defined by the absence of critical care-level organ support at enrollment, were randomized to a pragmatic strategy of therapeutic-dose anticoagulation with heparin or usual care pharmacological thromboprophylaxis. The primary outcome combined survival to hospital discharge and days free of organ support through 21 days, which was evaluated with Bayesian statistical models according to baseline D-dimer.\n\nResults The trial was stopped when prespecified criteria for superiority were met for therapeutic-dose anticoagulation in groups defined by high (≥2-fold elevated) and low (<2-fold elevated) D-dimer. Among 2219 participants in the final analysis, the probability that therapeutic anticoagulation increased organ support-free days compared to thromboprophylaxis was 99.0% (adjusted odds ratio 1.29, 95% credible interval 1.04 to 1.61). The adjusted absolute increase in survival to hospital discharge without organ support with therapeutic-dose anticoagulation was 4.6% (95% credible interval 0.7 to 8.1). In the primary adaptive stopping groups, the final probabilities of superiority for therapeutic anticoagulation were 97.3% in the high D-dimer group and 92.9% in the low D-dimer group. Major bleeding occurred in 1.9% and 0.9% of participants randomized to therapeutic anticoagulation and thromboprophylaxis, respectively.\n\nConclusions In non-critically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increases the probability of survival to hospital discharge with reduced use of organ support."
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"value" : "The ATTACC, ACTIV-4a, and REMAP-CAP Investigators, Patrick R. Lawler, Ewan C. Goligher, Jeffrey S. Berger, Matthew D. Neal, Bryan J. McVerry, Jose C. Nicolau, Michelle N. Gong, Marc Carrier, Robert S. Rosenson, Harmony R. Reynolds, Alexis F. Turgeon, Jorge Escobedo, David T. Huang, Charlotte Ann Bradbury, Brett L. Houston, Lucy Z. Kornblith, Anand Kumar, Susan R. Kahn, Mary Cushman, Zoe McQuilten, Arthur S. Slutsky, Keri S. Kim, Anthony C. Gordon, Bridget-Anne Kirwan, Maria M. Brooks, Alisa M. Higgins, Roger J. Lewis, Elizabeth Lorenzi, Scott M. Berry, Lindsay R. Berry, Derek C. Angus, Colin J. McArthur, Steven A. Webb, Michael E. Farkouh, Judith S. Hochman, Ryan Zarychanski"
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"value" : "REMAP-CAP: Supported by the European Union through FP7-HEALTH-2013-INNOVATION: the Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE) consortium (602525), and Horizon 2020 research and innovation program: the Rapid European Covid-19 Emergency Research response (RECOVER) consortium (101003589) and by the Australian National Health and Medical Research Council (APP1101719), the Health Research Council of New Zealand (16/631), a Canadian Institutes of Health Research Strategy for Patient-Oriented Research Innovative Clinical Trials Program Grant (158584), the U.K. NIHR and the NIHR Imperial Biomedical Research Centre, the Health Research Board of Ireland (CTN 2014-012), the UPMC Learning While Doing Program, the Breast Cancer Research Foundation, the French Ministry of Health (PHRC-20-0147), the Minderoo Foundation, Amgen, Eisai, the Global Coalition for Adaptive Research, and the Wellcome Trust Innovations Project (215522). Dr. Gordon is funded by an NIHR Research Professorship (RP-2015-06-18), and Dr. Shankar-Hari by an NIHR Clinician Scientist Fellowship (CS-2016-16-011). The ATTACC platform was supported by grants from the Canadian Institutes of Health Research, LifeArc Foundation, Thistledown Foundation, Research Manitoba, Ontario Ministry of Health, and the Peter Munk Cardiac Centre. The ACTIV-4a platform was sponsored by the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD and administered through OTA-20-011. Disclaimer: The views expressed in this publication are those of the author(s) and not necessarily those of the National Health Service (UK), the National Institute for Health Research (UK), the Department of Health and Social Care (UK), or of the National Institutes of Health (USA)."
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IG © 2024+ HL7 International / Clinical Decision Support.
Package hl7.fhir.uv.ebm#1.0.0-ballot3 based on FHIR 6.0.0-ballot5.
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2026-08-17
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