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
| Page standards status: Informative |
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Citation 179637</b></p><a name="179637"> </a><a name="hc179637"> </a><a name="179637-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: 10; Last updated: 2025-03-27 12:25:16+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-journal-article-citation.html">JournalArticleCitation</a></p></div><p><b>url</b>: <a href="Citation-179637.html">Citation 18508207 A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal.</a></p><p><b>identifier</b>: FEvIR Object Identifier/https://fevir.net/FOI/179637, <code>https://pubmed.ncbi.nlm.nih.gov</code>/18508207, <a href="http://terminology.hl7.org/6.2.0/NamingSystem-uri.html" title="As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt
This oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid:
Note that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.
This OID may also be used in CD.codeSystem.">Uniform Resource Identifier (URI)</a>/urn:oid:2.16.840.1.113883.4.642.40.44.15.3</p><p><b>version</b>: 1.0.0-ballot2</p><p><b>title</b>: 18508207 A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal.</p><p><b>status</b>: Active</p><p><b>date</b>: 2025-03-28 17:11:38+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>: </p><div><p>This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p>
</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://hl7.org/fhir/R5/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://hl7.org/fhir/citation-artifact-classifier medline-base}">Medline Base</span></td></tr></table><p><b>jurisdiction</b>: <span title="Codes:{http://unstats.un.org/unsd/methods/m49/m49.htm 001}">World</span></p><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>
</div><p><b>approvalDate</b>: 2008-12-16</p><p><b>lastReviewDate</b>: 2021-10-20</p><p><b>author</b>: Computable Publishing®: MEDLINE-to-FEvIR Converter: </p><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/citation-classification-type citation-source}">Citation Source</span></p><p><b>classifier</b>: <span title="Codes:">MEDLINE</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/citation-classification-type medline-owner}">MEDLINE Citation Owner</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/bsd/licensee/elements_descriptions.html#owner_value NLM}">National Library of Medicine, Index Section</span></p></blockquote><p><b>currentState</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type medline-medline}">Medline Citation Status of Medline</span>, <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-publication-status-ppublish}">PubMed PublicationStatus of ppublish</span></p><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-received}">PubMed Pubstatus of Received</span></p><p><b>period</b>: ?? --> 2007-11-22</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-revised}">PubMed Pubstatus of Revised</span></p><p><b>period</b>: ?? --> 2008-04-08</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-accepted}">PubMed Pubstatus of Accepted</span></p><p><b>period</b>: ?? --> 2008-04-09</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-pubmed}">PubMed Pubstatus of Pubmed</span></p><p><b>period</b>: ?? --> 2008-05-30 09:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-medline}">PubMed Pubstatus of Medline</span></p><p><b>period</b>: ?? --> 2008-12-17 09:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-entrez}">PubMed Pubstatus of Entrez</span></p><p><b>period</b>: ?? --> 2008-05-30 09:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-pmc-release}">PubMed Pubstatus of PMC release</span></p><p><b>period</b>: ?? --> 2009-09-01</p></blockquote><blockquote><p><b>citedArtifact</b></p><p><b>identifier</b>: <code>https://pubmed.ncbi.nlm.nih.gov</code>/18508207, mid/NIHMS61453, <code>https://www.ncbi.nlm.nih.gov/pmc/</code>/PMC2613766, <code>https://doi.org</code>/10.1016/j.drugalcdep.2008.04.002, pii/S0376-8716(08)00140-3</p><h3>Titles</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://hl7.org/fhir/title-type primary}">Primary title</span></td><td><span title="Codes:{urn:ietf:bcp:47 en}">English</span></td><td><div><p>A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal.</p>
</div></td></tr></table><h3>Abstracts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/cited-artifact-abstract-type primary-human-use}">Primary human use</span></td><td><div><p><strong>CONTEXT:</strong> Lofexidine is an alpha-2-adrenergic receptor agonist that is approved in the United Kingdom for the treatment of opioid withdrawal symptoms. Lofexidine has been reported to have more significant effects on decreasing opioid withdrawal symptoms with less hypotension than clonidine.
<strong>OBJECTIVE:</strong> To demonstrate that lofexidine is well tolerated and effective in the alleviation of observationally defined opioid withdrawal symptoms in opioid dependent individuals undergoing medically supervised opioid detoxification as compared to placebo.
<strong>DESIGN:</strong> An inpatient, Phase 3, placebo-controlled, double-blind, randomized multi-site trial with three phases: (1) opioid agonist stabilization phase (days 1-3), (2) detoxification/medication or placebo phase (days 4-8), and (3) post detoxification/medication phase (days 9-11).
<strong>SUBJECTS:</strong> Sixty-eight opioid dependent subjects were enrolled at three sites with 35 randomized to lofexidine and 33 to placebo.
<strong>MAIN OUTCOME MEASURE:</strong> Modified Himmelsbach Opiate Withdrawal Scale (MHOWS) on study day 5 (second opioid detoxification treatment day).
<strong>RESULTS:</strong> Due to significant findings, the study was terminated early. On the study day 5 MHOWS, subjects treated with lofexidine had significantly lower scores (equating to fewer/less severe withdrawal symptoms) than placebo subjects (least squares means 19.5+/-2.1 versus 30.9+/-2.7; p=0.0019). Lofexidine subjects had significantly better retention in treatment than placebo subjects (38.2% versus 15.2%; Log rank test p=0.01).
<strong>CONCLUSIONS:</strong> Lofexidine is well tolerated and more efficacious than placebo for reducing opioid withdrawal symptoms in inpatients undergoing medically supervised opioid detoxification.</p>
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**OBJECTIVE:** To demonstrate that lofexidine is well tolerated and effective in the alleviation of observationally defined opioid withdrawal symptoms in opioid dependent individuals undergoing medically supervised opioid detoxification as compared to placebo.
**DESIGN:** An inpatient, Phase 3, placebo-controlled, double-blind, randomized multi-site trial with three phases: (1) opioid agonist stabilization phase (days 1-3), (2) detoxification/medication or placebo phase (days 4-8), and (3) post detoxification/medication phase (days 9-11).
**SUBJECTS:** Sixty-eight opioid dependent subjects were enrolled at three sites with 35 randomized to lofexidine and 33 to placebo.
**MAIN OUTCOME MEASURE:** Modified Himmelsbach Opiate Withdrawal Scale (MHOWS) on study day 5 (second opioid detoxification treatment day).
**RESULTS:** Due to significant findings, the study was terminated early. On the study day 5 MHOWS, subjects treated with lofexidine had significantly lower scores (equating to fewer/less severe withdrawal symptoms) than placebo subjects (least squares means 19.5+/-2.1 versus 30.9+/-2.7; p=0.0019). Lofexidine subjects had significantly better retention in treatment than placebo subjects (38.2% versus 15.2%; Log rank test p=0.01).
**CONCLUSIONS:** Lofexidine is well tolerated and more efficacious than placebo for reducing opioid withdrawal symptoms in inpatients undergoing medically supervised opioid detoxification."/>
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<code value="knowledge-artifact-type"/>
<display value="Knowledge Artifact Type"/>
<userSelected value="false"/>
</coding>
</type>
<classifier>
<coding>
<system value="http://hl7.org/fhir/citation-artifact-classifier"/>
<code value="D016428"/>
<display value="Journal Article"/>
<userSelected value="false"/>
</coding>
</classifier>
<artifactAssessment>
<display value="Classifier added by Computable Publishing LLC"/>
</artifactAssessment>
</classification>
<classification>
<type>
<coding>
<system
value="http://hl7.org/fhir/cited-artifact-classification-type"/>
<code value="citation-subset"/>
<display value="Citation subset"/>
<userSelected value="false"/>
</coding>
</type>
<classifier>
<coding>
<system
value="https://www.nlm.nih.gov/bsd/licensee/elements_descriptions.html#citationsubset"/>
<code value="IM"/>
<display value="IM"/>
<userSelected value="false"/>
</coding>
</classifier>
</classification>
<contributorship>
<complete value="true"/>
<entry>
<contributor>
<reference value="#contributor0"/>
<type value="Practitioner"/>
<display value="Yu E"/>
</contributor>
<forenameInitials value="E"/>
<affiliation>
<display
value="University of Pennsylvania & Philadelphia Veterans Affairs Medical Center, Philadelphia VAMC 116, University & Woodland Avenues, Philadelphia, PA 19104, USA. yu_e@mail.trc.upenn.edu <yu_e@mail.trc.upenn.edu>"/>
</affiliation>
</entry>
<entry>
<contributor>
<reference value="#contributor1"/>
<type value="Practitioner"/>
<display value="Miotto K"/>
</contributor>
<forenameInitials value="K"/>
</entry>
<entry>
<contributor>
<reference value="#contributor2"/>
<type value="Practitioner"/>
<display value="Akerele E"/>
</contributor>
<forenameInitials value="E"/>
</entry>
<entry>
<contributor>
<reference value="#contributor3"/>
<type value="Practitioner"/>
<display value="Montgomery A"/>
</contributor>
<forenameInitials value="A"/>
</entry>
<entry>
<contributor>
<reference value="#contributor4"/>
<type value="Practitioner"/>
<display value="Elkashef A"/>
</contributor>
<forenameInitials value="A"/>
</entry>
<entry>
<contributor>
<reference value="#contributor5"/>
<type value="Practitioner"/>
<display value="Walsh R"/>
</contributor>
<forenameInitials value="R"/>
</entry>
<entry>
<contributor>
<reference value="#contributor6"/>
<type value="Practitioner"/>
<display value="Montoya I"/>
</contributor>
<forenameInitials value="I"/>
</entry>
<entry>
<contributor>
<reference value="#contributor7"/>
<type value="Practitioner"/>
<display value="Fischman MW"/>
</contributor>
<forenameInitials value="MW"/>
</entry>
<entry>
<contributor>
<reference value="#contributor8"/>
<type value="Practitioner"/>
<display value="Collins J"/>
</contributor>
<forenameInitials value="J"/>
</entry>
<entry>
<contributor>
<reference value="#contributor9"/>
<type value="Practitioner"/>
<display value="McSherry F"/>
</contributor>
<forenameInitials value="F"/>
</entry>
<entry>
<contributor>
<reference value="#contributor10"/>
<type value="Practitioner"/>
<display value="Boardman K"/>
</contributor>
<forenameInitials value="K"/>
</entry>
<entry>
<contributor>
<reference value="#contributor11"/>
<type value="Practitioner"/>
<display value="Davies DK"/>
</contributor>
<forenameInitials value="DK"/>
</entry>
<entry>
<contributor>
<reference value="#contributor12"/>
<type value="Practitioner"/>
<display value="O'Brien CP"/>
</contributor>
<forenameInitials value="CP"/>
</entry>
<entry>
<contributor>
<reference value="#contributor13"/>
<type value="Practitioner"/>
<display value="Ling W"/>
</contributor>
<forenameInitials value="W"/>
</entry>
<entry>
<contributor>
<reference value="#contributor14"/>
<type value="Practitioner"/>
<display value="Kleber H"/>
</contributor>
<forenameInitials value="H"/>
</entry>
<entry>
<contributor>
<reference value="#contributor15"/>
<type value="Practitioner"/>
<display value="Herman BH"/>
</contributor>
<forenameInitials value="BH"/>
</entry>
</contributorship>
</citedArtifact>
</Citation>
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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