Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
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-ballot 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
| Active as of 2021-10-08 |
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Citation</b><a name="7636"> </a><a name="hc7636"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceCitation "7636" Version "14" Updated "2023-12-02 22:23:17+0000" </p></div><p><b>url</b>: <code>https://fevir.net/resources/Citation/7636</code></p><p><b>identifier</b>: FEvIR Object Identifier/7636</p><p><b>version</b>: 1.0.0-ballot</p><p><b>title</b>: Anticoagulation for COVID-19 Combined RCTs in NEJM</p><p><b>status</b>: active</p><p><b>date</b>: 2021-10-08 12:41:11+0000</p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href="http://www.hl7.org/Special/committees/dss">http://www.hl7.org/Special/committees/dss</a></p><p><b>description</b>: The peer-reviewed report for combination of 3 adaptive RCTs</p><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>Program (Details: UsageContextType code program = 'Program', stated as 'Program')</td><td>EBMonFHIR/COKA Demonstration <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr><tr><td style="display: none">*</td><td>FEvIR Platform Use (Details: Citation Classification Type code fevir-platform-use = 'FEvIR Platform Use', stated as 'FEvIR Platform Use')</td><td>Project Specific <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#project-specific)</span></td></tr></table><p><b>jurisdiction</b>: World <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (m49.htm#001)</span></p><p><b>copyright</b>: https://creativecommons.org/licenses/by-nc-sa/4.0/</p><p><b>author</b>: Brian S. Alper: </p><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>Computable Publishing <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-summary-style.html">Citation Summary Style</a>#comppub)</span></td><td>Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19 [Journal Article]. Contributors: The ATTACC, ACTIV-4a, and REMAP-CAP Investigators. In: The New England Journal of Medicine, DOI 10.1056/NEJMoa2105911. Published August 04, 2021. Available at: https://doi.org/10.1056/NEJMoa2105911.</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>FEvIR Platform Use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-classification-type.html">Citation Classification Type</a>#fevir-platform-use)</span></td><td>Project Specific <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#project-specific)</span></td></tr></table><blockquote><p><b>citedArtifact</b></p><p><b>identifier</b>: <code>https://doi.org</code>/10.1056/NEJMoa2105911</p><p><b>relatedIdentifier</b>: <code>https://clinicaltrials.gov</code>/NCT02735707, <code>https://clinicaltrials.gov</code>/NCT04505774, <code>https://clinicaltrials.gov</code>/NCT04359277, <code>https://clinicaltrials.gov</code>/NCT04372589</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>Published final form <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-status-type.html">Cited Artifact Status Type</a>#published-final-form)</span></td><td>true</td><td>2021-08-05 --> (ongoing)</td></tr></table><blockquote><p><b>title</b></p><p><b>type</b>: Primary title <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-title-type.html">Title Type</a>#primary)</span></p><p><b>language</b>: English <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-ietf3066.html">Tags for the Identification of Languages</a>#en)</span></p><p><b>text</b>: Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19</p></blockquote><blockquote><p><b>title</b></p><p><b>type</b>: Title used in Supplement <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-title-type.html">Title Type</a>#earlier-title "Different text in an earlier version")</span></p><p><b>language</b>: English <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-ietf3066.html">Tags for the Identification of Languages</a>#en)</span></p><p><b>text</b>: Multi-Platform Randomized Controlled Trial Therapeutic Anticoagulation in Non-critically Ill Patients with
Covid-19</p></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>Primary human use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-abstract-type.html">Cited Artifact Abstract Type</a>#primary-human-use)</span></td><td>English <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-ietf3066.html">Tags for the Identification of Languages</a>#en)</span></td><td>BACKGROUND
Thrombosis and inflammation may contribute to the risk of death and complications among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19.
METHODS
In this open-label, adaptive, multiplatform, controlled trial, we randomly assigned patients who were hospitalized with Covid-19 and who were not critically ill (which was defined as an absence of critical care–level organ support at enrollment) to receive pragmatically defined regimens of either therapeutic-dose anticoagulation with heparin or usual-care pharmacologic thromboprophylaxis. The primary outcome was organ support–free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of −1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. This outcome was evaluated with the use of a Bayesian statistical model for all patients and according to the baseline d-dimer level.
RESULTS
The trial was stopped when prespecified criteria for the superiority of therapeutic-dose anticoagulation were met. Among 2219 patients in the final analysis, the probability that therapeutic-dose anticoagulation increased organ support–free days as compared with usual-care thromboprophylaxis was 98.6% (adjusted odds ratio, 1.27; 95% credible interval, 1.03 to 1.58). The adjusted absolute between-group difference in survival until hospital discharge without organ support favoring therapeutic-dose anticoagulation was 4.0 percentage points (95% credible interval, 0.5 to 7.2). The final probability of the superiority of therapeutic-dose anticoagulation over usual-care thromboprophylaxis was 97.3% in the high d-dimer cohort, 92.9% in the low d-dimer cohort, and 97.3% in the unknown d-dimer cohort. Major bleeding occurred in 1.9% of the patients receiving therapeutic-dose anticoagulation and in 0.9% of those receiving thromboprophylaxis.
CONCLUSIONS
In noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis. (ATTACC, ACTIV-4a, and REMAP-CAP ClinicalTrials.gov numbers, NCT04372589. opens in new tab, NCT04505774. opens in new tab, NCT02735707. opens in new tab, and NCT04359277. opens in new tab.)</td></tr></table><blockquote><p><b>relatesTo</b></p><p><b>type</b>: replaces</p><p><b>classifier</b>: Preprint <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#D000076942)</span></p><p><b>display</b>: Anticoagulation for COVID-19 Combined RCTs PrePrint</p><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://fevir.net/resources/Citation/5192">https://fevir.net/resources/Citation/5192</a></td></tr></table><p><b>resourceReference</b>: <span>FEvIR Object Identifier/5192</span></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: comment-in</p><p><b>classifier</b>: Editorial <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#classified-as-editorial)</span>, Journal Article <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#D016428)</span></p><p><b>display</b>: Surviving Covid-19 with Heparin?</p><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://www.nejm.org/doi/full/10.1056/NEJMe2111151">https://www.nejm.org/doi/full/10.1056/NEJMe2111151</a></td></tr></table><p><b>resourceReference</b>: <span><code>https://doi.org</code>/10.1056/NEJMe2111151</span></p></blockquote><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>Identifier</b></td><td><b>Title</b></td><td><b>Publisher</b></td></tr><tr><td style="display: none">*</td><td>Periodical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-published-in-type.html">Published In Type</a>#D020492)</span></td><td>Electronic ISSN/1533-4406, Medline Title Abbreviation/N Engl J Med</td><td>The New England Journal of Medicine</td><td><span>: Massachusetts Medical Society</span></td></tr></table><p><b>articleDate</b>: 2021-08-04</p><p><b>language</b>: English <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-ietf3066.html">Tags for the Identification of Languages</a>#en)</span></p><p><b>pageCount</b>: 13 pages</p><p><b>copyright</b>: Copyright © 2021 Massachusetts Medical Society. All rights reserved.</p></blockquote><blockquote><p><b>webLocation</b></p><p><b>classifier</b>: DOI Based <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-artifact-url-classifier.html">Artifact Url Classifier</a>#doi-based)</span></p><p><b>url</b>: <a href="https://doi.org/10.1056/NEJMoa2105911">https://doi.org/10.1056/NEJMoa2105911</a></p></blockquote><blockquote><p><b>webLocation</b></p><p><b>classifier</b>: Full-Text <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-artifact-url-classifier.html">Artifact Url Classifier</a>#full-text)</span></p><p><b>url</b>: <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2105911">https://www.nejm.org/doi/full/10.1056/NEJMoa2105911</a></p></blockquote><blockquote><p><b>webLocation</b></p><p><b>classifier</b>: PDF <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-artifact-url-classifier.html">Artifact Url Classifier</a>#pdf)</span></p><p><b>url</b>: <a href="https://www.nejm.org/doi/pdf/10.1056/NEJMoa2105911?articleTools=true">https://www.nejm.org/doi/pdf/10.1056/NEJMoa2105911?articleTools=true</a></p></blockquote><blockquote><p><b>webLocation</b></p><p><b>classifier</b>: Supplement <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-artifact-url-classifier.html">Artifact Url Classifier</a>#supplement)</span>, PDF <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-artifact-url-classifier.html">Artifact Url Classifier</a>#pdf)</span></p><p><b>url</b>: <a href="https://www.nejm.org/doi/suppl/10.1056/NEJMoa2105911/suppl_file/nejmoa2105911_appendix.pdf">https://www.nejm.org/doi/suppl/10.1056/NEJMoa2105911/suppl_file/nejmoa2105911_appendix.pdf</a></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Knowledge Artifact Type <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#knowledge-artifact-type)</span></p><p><b>classifier</b>: Journal Article <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#D016428)</span>, Evidence <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#evidence)</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Clinical Area <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#defined-in-text "Defined in text")</span></p><p><b>classifier</b>: Intensive Care and Critical Care Medicine <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#defined-in-text "Defined in text")</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Evidence Synthesis Level <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#defined-in-text "Defined in text")</span></p><p><b>classifier</b>: Single Study <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#defined-in-text "Defined in text")</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Clinical Topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#defined-in-text "Defined in text")</span></p><p><b>classifier</b>: COVID <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#defined-in-text "Defined in text")</span>, Anticoagulation <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#defined-in-text "Defined in text")</span>, COVID Anticoagulation <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#defined-in-text "Defined in text")</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Owner/Steward <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#defined-in-text "Defined in text")</span></p><p><b>classifier</b>: NLM/MEDLINE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#defined-in-text "Defined in text")</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: AHRQ Produced <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#defined-in-text "Defined in text")</span></p><p><b>classifier</b>: No <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#defined-in-text "Defined in text")</span></p></blockquote><blockquote><p><b>contributorship</b></p><blockquote><p><b>summary</b></p><p><b>type</b>: Author string <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-contributor-summary-type.html">Contributor Summary Type</a>#author-string)</span></p><p><b>source</b>: Copied from article <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-contributor-summary-source.html">Contributor Summary Source</a>#article-copy)</span></p><p><b>value</b>: The ATTACC, ACTIV-4a, and REMAP-CAP Investigators</p></blockquote><blockquote><p><b>summary</b></p><p><b>type</b>: Funding statement <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-contributor-summary-type.html">Contributor Summary Type</a>#funding-statement)</span></p><p><b>source</b>: Copied from article <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-contributor-summary-source.html">Contributor Summary Source</a>#article-copy)</span></p><p><b>value</b>: The ATTACC platform was supported by grants from the Canadian Institutes of Health Research, LifeArc Foundation, Thistledown Foundation, Research Manitoba, Ontario Ministry of Health, Peter Munk Cardiac Centre, CancerCare Manitoba Foundation, and Victoria General Hospital Foundation. The ACTIV-4a platform was sponsored by the National Heart, Lung, and Blood Institute, National Institutes of Health (NIH) (grant numbers, OTA-20-011 and 1OT2HL156812-01). The pilot program (PROTECT) was funded in part by a grant (UL1TR001445) from the New York University Clinical and Translational Science Award program, supported by the National Center for Advancing Translational Sciences of the NIH. The REMAP-CAP platform was supported by the European Union through FP7-HEALTH-2013-INNOVATION: the Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE) consortium (602525) and the Horizon 2020 research and innovation program: the Rapid European Covid-19 Emergency Research response (RECOVER) consortium (101003589); by the Australian National Health and Medical Research Council (APP1101719 and APP1116530), the Health Research Council of New Zealand (16/631), the Canadian Institutes of Health Research (Strategy for Patient-Oriented Research Innovative Clinical Trials Program Grant [158584] and Covid-19 Rapid Research Operating Grant [447335]), the U.K. National Institute for Health Research (NIHR) and the NIHR Imperial Biomedical Research Centre, the Health Research Board of Ireland (CTN 2014-012), the Learning While Doing Program at the University of Pittsburgh Medical Center, 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. Goligher is the recipient of an Early Career Investigator award from the Canadian Institutes of Health Research (grant AR7-162822). Dr. Gordon is supported by an NIHR Research Professorship (RP-2015-06-18), Dr. Shankar-Hari by an NIHR Clinician Scientist Fellowship (CS-2016-16-011), and Dr. Turgeon by a Canada Research Chair (Tier 2). Dr. Zarychanski is the recipient of the Lyonel G. Israels Research Chair in Hematology (University of Manitoba).</p></blockquote><blockquote><p><b>summary</b></p><p><b>type</b>: Contributorship statement <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-contributor-summary-type.html">Contributor Summary Type</a>#contributorship-statement)</span></p><p><b>source</b>: Copied from article <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-contributor-summary-source.html">Contributor Summary Source</a>#article-copy)</span></p><p><b>value</b>: Drs. Lawler, Goligher, Berger, Neal, and McVerry and Drs. McArthur, Webb, Farkouh, Hochman, and Zarychanski contributed equally to this article.
The members of the executive writing committee are as follows: Patrick R. Lawler, M.D., M.P.H., Ewan C. Goligher, M.D., Ph.D., Jeffrey S. Berger, M.D., Matthew D. Neal, M.D., Bryan J. McVerry, M.D, Jose C. Nicolau, M.D., Ph.D., Michelle N. Gong, M.D., Marc Carrier, M.D., Robert S. Rosenson, M.D., Harmony R. Reynolds, M.D., Alexis F. Turgeon, M.D., Jorge Escobedo, M.D., David T. Huang, M.D., M.P.H., Charlotte A. Bradbury, M.B., Ch.B., Ph.D., Brett L. Houston, M.D., Lucy Z. Kornblith, M.D., Anand Kumar, M.D., Susan R. Kahn, M.D., Mary Cushman, M.D., Zoe McQuilten, Ph.D., Arthur S. Slutsky, M.D., Keri S. Kim, Pharm.D., Anthony C. Gordon, M.B., B.S., M.D., Bridget-Anne Kirwan, Ph.D., Maria M. Brooks, Ph.D., Alisa M. Higgins, Ph.D., Roger J. Lewis, M.D., Ph.D., Elizabeth Lorenzi, Ph.D., Scott M. Berry, Ph.D., Lindsay R. Berry, Ph.D., Derek C. Angus, M.D., M.P.H., Colin J. McArthur, M.B., Ch.B., Steven A. Webb, M.P.H., Ph.D., Michael E. Farkouh, M.D., Judith S. Hochman, M.D., and Ryan Zarychanski, M.D.
The members of the block writing committee are as follows: Aaron W. Aday, M.D., Farah Al-Beidh, Ph.D., Djillali Annane, M.D., Ph.D., Yaseen M. Arabi, M.D., Diptesh Aryal, M.D., Lisa Baumann Kreuziger, M.D., Abi Beane, Ph.D., Zahra Bhimani, M.P.H., Shailesh Bihari, Ph.D., Henny H. Billett, M.D., Lindsay Bond, H.B.Sc., Marc Bonten, Ph.D., Frank Brunkhorst, M.D., Meredith Buxton, Ph.D., Adrian Buzgau, B.A.S., Lana A. Castellucci, M.D., Sweta Chekuri, M.D., Jen-Ting Chen, M.D., Allen C. Cheng, Ph.D., Tamta Chkhikvadze, M.D., Benjamin Coiffard, M.D., Todd W. Costantini, M.D., Sophie de Brouwer, Ph.D., Lennie P.G. Derde, M.D., Ph.D., Michelle A. Detry, Ph.D., Abhijit Duggal, M.D., M.P.H., Vladimír Džavík, M.D., Mark B. Effron, M.D., Lise J. Estcourt, M.B., B.Chir., D.Phil., Brendan M. Everett, M.D., M.P.H., Dean A. Fergusson, Ph.D., Mark Fitzgerald, Ph.D., Robert A. Fowler, M.D., Jean P. Galanaud, M.D., Benjamin T. Galen, M.D., Sheetal Gandotra, M.D., Sebastian García-Madrona, M.D., Timothy D. Girard, M.D., Lucas C. Godoy, M.D., Andrew L. Goodman, M.D., Herman Goossens, M.D., Cameron Green, M.Sc., Yonatan Y. Greenstein, M.D., Peter L. Gross, M.D., Naomi M. Hamburg, M.D., Rashan Haniffa, Ph.D., George Hanna, M.D., Nicholas Hanna, M.D., Sheila M. Hegde, M.D., M.P.H., Carolyn M. Hendrickson, M.D., R. Duncan Hite, M.D., Alexander A. Hindenburg, M.D., Aluko A. Hope, M.D., James M. Horowitz, M.D., Christopher M. Horvat, M.D., M.H.A., Kristin Hudock, M.D., Beverley J. Hunt, M.D., Mansoor Husain, M.D., Robert C. Hyzy, M.D., Vivek N. Iyer, M.D., M.P.H., Jeffrey R. Jacobson, M.D., Devachandran Jayakumar, M.D., Norma M. Keller, M.D., Akram Khan, M.D., Yuri Kim, M.D., Ph.D., Andrei L. Kindzelski, M.D., Ph.D., Andrew J. King, Ph.D., M. Margaret Knudson, M.D., Aaron E. Kornblith, M.D., Vidya Krishnan, M.D., M.H.S., Matthew E. Kutcher, M.D., Michael A. Laffan, D.M., Francois Lamontagne, M.D., Grégoire Le Gal, M.D., Ph.D., Christine M. Leeper, M.D., Eric S. Leifer, Ph.D., George Lim, M.D., Felipe Gallego Lima, M.D., Kelsey Linstrum, M.S., Edward Litton, Ph.D., Jose Lopez-Sendon, Ph.D., Jose L. Lopez-Sendon Moreno, M.D., Sylvain A. Lother, M.D., Saurabh Malhotra, M.D., M.P.H., Miguel Marcos, Ph.D., Andréa Saud Marinez, Pharm.D., John C. Marshall, M.D., Nicole Marten, R.N., Michael A. Matthay, M.D., Daniel F. McAuley, M.D., Emily G. McDonald, M.D., Anna McGlothlin, Ph.D., Shay P. McGuinness, M.B., Ch.B., Saskia Middeldorp, M.D., Ph.D., Stephanie K. Montgomery, M.Sc., Steven C. Moore, M.D., Raquel Morillo Guerrero, Ph.D., Paul R. Mouncey, M.Sc., Srinivas Murthy, M.D., Girish B. Nair, M.D., Rahul Nair, M.D., Alistair D. Nichol, M.B., Ph.D., Brenda Nunez-Garcia, B.A., Ambarish Pandey, M.D., Pauline K. Park, M.D., Rachael L. Parke, Ph.D., Jane C. Parker, B.N., Sam Parnia, M.D., Ph.D., Jonathan D. Paul, M.D., Yessica S. Pérez González, M.D., Mauricio Pompilio, Ph.D., Matthew E. Prekker, M.D., M.P.H., John G. Quigley, M.D., Natalia S. Rost, M.D., Kathryn Rowan, Ph.D., Fernanda O. Santos, M.D., Marlene Santos, M.D., Mayler Olombrada Santos, M.Sc., Lewis Satterwhite, M.D., Christina T. Saunders, Ph.D., Roger E.G. Schutgens, M.D., Ph.D., Christopher W. Seymour, M.D., Deborah M. Siegal, M.D., Delcio G. Silva, Jr., M.Med., Manu Shankar-Hari, Ph.D., John P. Sheehan, M.D., Aneesh B. Singhal, M.D., Dayna Solvason, Simon J. Stanworth, D.Phil., Tobias Tritschler, M.D., Anne M. Turner, M.P.H., Wilma van Bentum-Puijk, M.Sc., Frank L. van de Veerdonk, M.D., Ph.D., Sean van Diepen, M.D., Gloria Vazquez-Grande, M.D., Lana Wahid, M.D., Vanessa Wareham, H.B.Sc., Bryan J. Wells, M.D., R. Jay Widmer, M.D., Ph.D., Jennifer G. Wilson, M.D., Eugene Yuriditsky, M.D., and Fernando G. Zampieri, M.D., Ph.D.</p></blockquote></blockquote></blockquote></div>
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Thrombosis and inflammation may contribute to the risk of death and complications among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19.
METHODS
In this open-label, adaptive, multiplatform, controlled trial, we randomly assigned patients who were hospitalized with Covid-19 and who were not critically ill (which was defined as an absence of critical care–level organ support at enrollment) to receive pragmatically defined regimens of either therapeutic-dose anticoagulation with heparin or usual-care pharmacologic thromboprophylaxis. The primary outcome was organ support–free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of −1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. This outcome was evaluated with the use of a Bayesian statistical model for all patients and according to the baseline d-dimer level.
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The trial was stopped when prespecified criteria for the superiority of therapeutic-dose anticoagulation were met. Among 2219 patients in the final analysis, the probability that therapeutic-dose anticoagulation increased organ support–free days as compared with usual-care thromboprophylaxis was 98.6% (adjusted odds ratio, 1.27; 95% credible interval, 1.03 to 1.58). The adjusted absolute between-group difference in survival until hospital discharge without organ support favoring therapeutic-dose anticoagulation was 4.0 percentage points (95% credible interval, 0.5 to 7.2). The final probability of the superiority of therapeutic-dose anticoagulation over usual-care thromboprophylaxis was 97.3% in the high d-dimer cohort, 92.9% in the low d-dimer cohort, and 97.3% in the unknown d-dimer cohort. Major bleeding occurred in 1.9% of the patients receiving therapeutic-dose anticoagulation and in 0.9% of those receiving thromboprophylaxis.
CONCLUSIONS
In noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis. (ATTACC, ACTIV-4a, and REMAP-CAP ClinicalTrials.gov numbers, NCT04372589. opens in new tab, NCT04505774. opens in new tab, NCT02735707. opens in new tab, and NCT04359277. opens in new tab.)"/>
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value="The ATTACC platform was supported by grants from the Canadian Institutes of Health Research, LifeArc Foundation, Thistledown Foundation, Research Manitoba, Ontario Ministry of Health, Peter Munk Cardiac Centre, CancerCare Manitoba Foundation, and Victoria General Hospital Foundation. The ACTIV-4a platform was sponsored by the National Heart, Lung, and Blood Institute, National Institutes of Health (NIH) (grant numbers, OTA-20-011 and 1OT2HL156812-01). The pilot program (PROTECT) was funded in part by a grant (UL1TR001445) from the New York University Clinical and Translational Science Award program, supported by the National Center for Advancing Translational Sciences of the NIH. The REMAP-CAP platform was supported by the European Union through FP7-HEALTH-2013-INNOVATION: the Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE) consortium (602525) and the Horizon 2020 research and innovation program: the Rapid European Covid-19 Emergency Research response (RECOVER) consortium (101003589); by the Australian National Health and Medical Research Council (APP1101719 and APP1116530), the Health Research Council of New Zealand (16/631), the Canadian Institutes of Health Research (Strategy for Patient-Oriented Research Innovative Clinical Trials Program Grant [158584] and Covid-19 Rapid Research Operating Grant [447335]), the U.K. National Institute for Health Research (NIHR) and the NIHR Imperial Biomedical Research Centre, the Health Research Board of Ireland (CTN 2014-012), the Learning While Doing Program at the University of Pittsburgh Medical Center, 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. Goligher is the recipient of an Early Career Investigator award from the Canadian Institutes of Health Research (grant AR7-162822). Dr. Gordon is supported by an NIHR Research Professorship (RP-2015-06-18), Dr. Shankar-Hari by an NIHR Clinician Scientist Fellowship (CS-2016-16-011), and Dr. Turgeon by a Canada Research Chair (Tier 2). Dr. Zarychanski is the recipient of the Lyonel G. Israels Research Chair in Hematology (University of Manitoba)."/>
</summary>
<summary>
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value="Drs. Lawler, Goligher, Berger, Neal, and McVerry and Drs. McArthur, Webb, Farkouh, Hochman, and Zarychanski contributed equally to this article.
The members of the executive writing committee are as follows: Patrick R. Lawler, M.D., M.P.H., Ewan C. Goligher, M.D., Ph.D., Jeffrey S. Berger, M.D., Matthew D. Neal, M.D., Bryan J. McVerry, M.D, Jose C. Nicolau, M.D., Ph.D., Michelle N. Gong, M.D., Marc Carrier, M.D., Robert S. Rosenson, M.D., Harmony R. Reynolds, M.D., Alexis F. Turgeon, M.D., Jorge Escobedo, M.D., David T. Huang, M.D., M.P.H., Charlotte A. Bradbury, M.B., Ch.B., Ph.D., Brett L. Houston, M.D., Lucy Z. Kornblith, M.D., Anand Kumar, M.D., Susan R. Kahn, M.D., Mary Cushman, M.D., Zoe McQuilten, Ph.D., Arthur S. Slutsky, M.D., Keri S. Kim, Pharm.D., Anthony C. Gordon, M.B., B.S., M.D., Bridget-Anne Kirwan, Ph.D., Maria M. Brooks, Ph.D., Alisa M. Higgins, Ph.D., Roger J. Lewis, M.D., Ph.D., Elizabeth Lorenzi, Ph.D., Scott M. Berry, Ph.D., Lindsay R. Berry, Ph.D., Derek C. Angus, M.D., M.P.H., Colin J. McArthur, M.B., Ch.B., Steven A. Webb, M.P.H., Ph.D., Michael E. Farkouh, M.D., Judith S. Hochman, M.D., and Ryan Zarychanski, M.D.
The members of the block writing committee are as follows: Aaron W. Aday, M.D., Farah Al-Beidh, Ph.D., Djillali Annane, M.D., Ph.D., Yaseen M. Arabi, M.D., Diptesh Aryal, M.D., Lisa Baumann Kreuziger, M.D., Abi Beane, Ph.D., Zahra Bhimani, M.P.H., Shailesh Bihari, Ph.D., Henny H. Billett, M.D., Lindsay Bond, H.B.Sc., Marc Bonten, Ph.D., Frank Brunkhorst, M.D., Meredith Buxton, Ph.D., Adrian Buzgau, B.A.S., Lana A. Castellucci, M.D., Sweta Chekuri, M.D., Jen-Ting Chen, M.D., Allen C. Cheng, Ph.D., Tamta Chkhikvadze, M.D., Benjamin Coiffard, M.D., Todd W. Costantini, M.D., Sophie de Brouwer, Ph.D., Lennie P.G. Derde, M.D., Ph.D., Michelle A. Detry, Ph.D., Abhijit Duggal, M.D., M.P.H., Vladimír Džavík, M.D., Mark B. Effron, M.D., Lise J. Estcourt, M.B., B.Chir., D.Phil., Brendan M. Everett, M.D., M.P.H., Dean A. Fergusson, Ph.D., Mark Fitzgerald, Ph.D., Robert A. Fowler, M.D., Jean P. Galanaud, M.D., Benjamin T. Galen, M.D., Sheetal Gandotra, M.D., Sebastian García-Madrona, M.D., Timothy D. Girard, M.D., Lucas C. Godoy, M.D., Andrew L. Goodman, M.D., Herman Goossens, M.D., Cameron Green, M.Sc., Yonatan Y. Greenstein, M.D., Peter L. Gross, M.D., Naomi M. Hamburg, M.D., Rashan Haniffa, Ph.D., George Hanna, M.D., Nicholas Hanna, M.D., Sheila M. Hegde, M.D., M.P.H., Carolyn M. Hendrickson, M.D., R. Duncan Hite, M.D., Alexander A. Hindenburg, M.D., Aluko A. Hope, M.D., James M. Horowitz, M.D., Christopher M. Horvat, M.D., M.H.A., Kristin Hudock, M.D., Beverley J. Hunt, M.D., Mansoor Husain, M.D., Robert C. Hyzy, M.D., Vivek N. Iyer, M.D., M.P.H., Jeffrey R. Jacobson, M.D., Devachandran Jayakumar, M.D., Norma M. Keller, M.D., Akram Khan, M.D., Yuri Kim, M.D., Ph.D., Andrei L. Kindzelski, M.D., Ph.D., Andrew J. King, Ph.D., M. Margaret Knudson, M.D., Aaron E. Kornblith, M.D., Vidya Krishnan, M.D., M.H.S., Matthew E. Kutcher, M.D., Michael A. Laffan, D.M., Francois Lamontagne, M.D., Grégoire Le Gal, M.D., Ph.D., Christine M. Leeper, M.D., Eric S. Leifer, Ph.D., George Lim, M.D., Felipe Gallego Lima, M.D., Kelsey Linstrum, M.S., Edward Litton, Ph.D., Jose Lopez-Sendon, Ph.D., Jose L. Lopez-Sendon Moreno, M.D., Sylvain A. Lother, M.D., Saurabh Malhotra, M.D., M.P.H., Miguel Marcos, Ph.D., Andréa Saud Marinez, Pharm.D., John C. Marshall, M.D., Nicole Marten, R.N., Michael A. Matthay, M.D., Daniel F. McAuley, M.D., Emily G. McDonald, M.D., Anna McGlothlin, Ph.D., Shay P. McGuinness, M.B., Ch.B., Saskia Middeldorp, M.D., Ph.D., Stephanie K. Montgomery, M.Sc., Steven C. Moore, M.D., Raquel Morillo Guerrero, Ph.D., Paul R. Mouncey, M.Sc., Srinivas Murthy, M.D., Girish B. Nair, M.D., Rahul Nair, M.D., Alistair D. Nichol, M.B., Ph.D., Brenda Nunez-Garcia, B.A., Ambarish Pandey, M.D., Pauline K. Park, M.D., Rachael L. Parke, Ph.D., Jane C. Parker, B.N., Sam Parnia, M.D., Ph.D., Jonathan D. Paul, M.D., Yessica S. Pérez González, M.D., Mauricio Pompilio, Ph.D., Matthew E. Prekker, M.D., M.P.H., John G. Quigley, M.D., Natalia S. Rost, M.D., Kathryn Rowan, Ph.D., Fernanda O. Santos, M.D., Marlene Santos, M.D., Mayler Olombrada Santos, M.Sc., Lewis Satterwhite, M.D., Christina T. Saunders, Ph.D., Roger E.G. Schutgens, M.D., Ph.D., Christopher W. Seymour, M.D., Deborah M. Siegal, M.D., Delcio G. Silva, Jr., M.Med., Manu Shankar-Hari, Ph.D., John P. Sheehan, M.D., Aneesh B. Singhal, M.D., Dayna Solvason, Simon J. Stanworth, D.Phil., Tobias Tritschler, M.D., Anne M. Turner, M.P.H., Wilma van Bentum-Puijk, M.Sc., Frank L. van de Veerdonk, M.D., Ph.D., Sean van Diepen, M.D., Gloria Vazquez-Grande, M.D., Lana Wahid, M.D., Vanessa Wareham, H.B.Sc., Bryan J. Wells, M.D., R. Jay Widmer, M.D., Ph.D., Jennifer G. Wilson, M.D., Eugene Yuriditsky, M.D., and Fernando G. Zampieri, M.D., Ph.D."/>
</summary>
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IG © 2022+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-05-16
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