Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot2: STU1 Ballot 2) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, see the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Group 346486</b></p><a name="346486"> </a><a name="hc346486"> </a><a name="346486-en-US"> </a><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">version: 2; Last updated: 2025-03-05 19:33:28+0000</p></div><p><b>Artifact Author</b>: Brian S. Alper, MD, MSPH: </p><p><b>url</b>: <a href="https://fevir.net/resources/Group/346486">https://fevir.net/resources/Group/346486</a></p><p><b>identifier</b>: FEvIR Object Identifier/https://fevir.net/FOI/346486, FEvIR Linking Identifier/CTIS2024-516402-32-00 Eligibility Criteria</p><p><b>name</b>: CTIS2024_516402_32_00_Eligibility_Criteria</p><p><b>title</b>: CTIS2024-516402-32-00 Eligibility Criteria</p><p><b>status</b>: Active</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>This Group Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p>
</div><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>
</div><p><b>membership</b>: Conceptual</p><p><b>combinationMethod</b>: All of</p><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">Age ≥ 18 years</span></p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">Hospitalization forHE-aHUS within prior 10 days: o Presume acute renal failure (renal replacement therapy or serum creatinine ≥ 354μM). o Mechanical hemolysis including: anemia, thrombopenia, and: low haptoglobin (1,5UNL), or presence of schistocytes o Severe hypertension with systolic blood pressure >180mmHg and/or diastolic blood pressure>110mmHg o Target organ damage, including neurological involvement (notably hypertensive encephalopathy, headache, confusion, nausea, posterior reversible encephalopathy syndrome), or cardiovascular involvement (notably acute left ventricular failure, acute pulmonary edema, acute cardiac ischemia, chest pain, dyspnea, palpitations), or ophtalmological involvement (notably ischemic retinopathy or blurred vision)</span></p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">For women of childbearing potential: Effective contraception during the study and for at least 5 months after the last dose of treatment with eculizumab</span></p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">Subject affiliated to a social security regimen</span></p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">Subject having signed written informed consent</span></p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">Atrophic kidneys with maximum length<8cm on recent (<1 month) renal ultrasound, CT scan, or renal MRI</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">Contra-indication to eculizumab or renin angiotensin system blockers</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">Solid organ or haematopoietic transplant</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">History (<1year) of active cancer or exposition to drugs associated with aHUS (< 3 months)</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">Severe cognitive or psychiatric disorders, patients unable to give an informed consent</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">PCR SARS-CoV2 positive</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">Pregnant or breastfeeding woman or ineffective contraception</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">Persons deprived of their liberty by judicial or administrative decision</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">Persons under legal protection (guardianship, curatorship)</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">High clinical suspicion of Complement-mediated aHUS (including familial history of aHUS)</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">High clinical suspicion of typical HUS (including Shiga Toxin-producing E. Coli infection) or Thrombotic thrombocytopenic purpura</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">High clinical suspicion of secondary HUS related to autoimmune disease (including lupus, scleroderma, antiphospholipid syndrome, ANCA vasculitis), or C3 glomerulopathy.</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">High clinical suspicion of recent hemorrhagic or ischemic stroke</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">ADAMTS 13<10%, HIV or HCV infection, positivity of 2 markers among: anticardiolipin IgG/antiBeta2 GP1 IgG/lupus anticoagulant, positivity of ANCA (ELISA PR3 or MPO)</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">Active infection</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">Subjects with unresolved Neisseria meningitidis infection</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criterion</span></p><p><b>value</b>: <span title="Codes:">Subjects refusing Neisseria meningitidis vaccination or refusing antibioprophylaxis with oracillin (In case of penicillin allergy, antibioprophylaxis with macrolide couldbeproposed according to ANSM recommendations (azithromycin or roxithromycin))</span></p><p><b>exclude</b>: true</p></blockquote></div>
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IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot2 based on FHIR 6.0.0-ballot2. Generated 2025-03-28
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