Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
2.0.0-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 2.0.0-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 2024-11-21 |
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Citation 179626</b></p><a name="179626"> </a><a name="hc179626"> </a><a name="179626-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: 8; Last updated: 2024-07-18 17:58:18+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-179626.html">Citation 22056152 Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial.</a></p><p><b>identifier</b>: FEvIR Object Identifier/179626, <code>https://pubmed.ncbi.nlm.nih.gov</code>/22056152, <a href="http://terminology.hl7.org/6.1.0/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
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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:2.16.840.1.113883.4.642.40.44.15.21</p><p><b>version</b>: 2.0.0-ballot</p><p><b>title</b>: 22056152 Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial.</p><p><b>status</b>: Active</p><p><b>date</b>: 2024-11-21 14:09:14+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>: 2012-01-03</p><p><b>lastReviewDate</b>: 2022-03-21</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-entrez}">PubMed Pubstatus of Entrez</span></p><p><b>period</b>: ?? --> 2011-11-08 06:00:00+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-pubmed}">PubMed Pubstatus of Pubmed</span></p><p><b>period</b>: ?? --> 2011-11-08 06:00:00+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>: ?? --> 2012-01-04 06:00:00+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>: ?? --> 2011-12-17</p></blockquote><blockquote><p><b>citedArtifact</b></p><p><b>identifier</b>: <code>https://pubmed.ncbi.nlm.nih.gov</code>/22056152, <code>https://www.ncbi.nlm.nih.gov/pmc/</code>/PMC3243932, <code>https://doi.org</code>/10.1016/S0140-6736(11)61095-7, pii/S0140-6736(11)61095-7</p><p><b>relatedIdentifier</b>: ISRCTN24991896, <code>https://clinicaltrials.gov</code>/NCT00002633</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>Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial.</p>
</div></td></tr></table><h3>Abstracts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td><td><b>Copyright</b></td></tr><tr><td style="display: none">*</td><td><div><p><strong>BACKGROUND:</strong> Whether the addition of radiation therapy (RT) improves overall survival in men with locally advanced prostate cancer managed with androgen deprivation therapy (ADT) is unclear. Our aim was to compare outcomes in such patients with locally advanced prostate cancer.
<strong>METHODS:</strong> Patients with: locally advanced (T3 or T4) prostate cancer (n=1057); or organ-confined disease (T2) with either a prostate-specific antigen (PSA) concentration more than 40 ng/mL (n=119) or PSA concentration more than 20 ng/mL and a Gleason score of 8 or higher (n=25), were randomly assigned (done centrally with stratification and dynamic minimisation, not masked) to receive lifelong ADT and RT (65-69 Gy to the prostate and seminal vesicles, 45 Gy to the pelvic nodes). The primary endpoint was overall survival. The results presented here are of an interim analysis planned for when two-thirds of the events for the final analysis were recorded. All efficacy analyses were done by intention to treat and were based on data from all patients. This trial is registered at controlledtrials.com as ISRCTN24991896 and Clinicaltrials.gov as NCT00002633.
<strong>RESULTS:</strong> Between 1995 and 2005, 1205 patients were randomly assigned (602 in the ADT only group and 603 in the ADT and RT group); median follow-up was 6·0 years (IQR 4·4-8·0). At the time of analysis, a total of 320 patients had died, 175 in the ADT only group and 145 in the ADT and RT group. The addition of RT to ADT improved overall survival at 7 years (74%, 95% CI 70-78 vs 66%, 60-70; hazard ratio [HR] 0·77, 95% CI 0·61-0·98, p=0·033). Both toxicity and health-related quality-of-life results showed a small effect of RT on late gastrointestinal toxicity (rectal bleeding grade >3, three patients (0·5%) in the ADT only group, two (0·3%) in the ADT and RT group; diarrhoea grade >3, four patients (0·7%) vs eight (1·3%); urinary toxicity grade >3, 14 patients (2·3%) in both groups).
<strong>INTERPRETATION:</strong> The benefits of combined modality treatment--ADT and RT--should be discussed with all patients with locally advanced prostate cancer.
<strong>FUNDING:</strong> Canadian Cancer Society Research Institute, US National Cancer Institute, and UK Medical Research Council.</p>
</div></td><td><div><p>Copyright © 2011 Elsevier Ltd. All rights reserved.</p>
</div></td></tr></table><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2008;127:2893–2917.</p>
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</div><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://pubmed.ncbi.nlm.nih.gov/19516032/">https://pubmed.ncbi.nlm.nih.gov/19516032/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/19516032</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Horwitz EM, Bae K, Hanks GE. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008;26:2497–2504.</p>
</div><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://pubmed.ncbi.nlm.nih.gov/18413638/">https://pubmed.ncbi.nlm.nih.gov/18413638/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/18413638</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Alibhai SM, Duong-Hua M, Cheung AM. Fracture types and risk factors in men with prostate cancer on androgen deprivation therapy: a matched cohort study of 19,079 men. J Urol. 2010;184:918–923.</p>
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value="**BACKGROUND:** Whether the addition of radiation therapy (RT) improves overall survival in men with locally advanced prostate cancer managed with androgen deprivation therapy (ADT) is unclear. Our aim was to compare outcomes in such patients with locally advanced prostate cancer.
**METHODS:** Patients with: locally advanced (T3 or T4) prostate cancer (n=1057); or organ-confined disease (T2) with either a prostate-specific antigen (PSA) concentration more than 40 ng/mL (n=119) or PSA concentration more than 20 ng/mL and a Gleason score of 8 or higher (n=25), were randomly assigned (done centrally with stratification and dynamic minimisation, not masked) to receive lifelong ADT and RT (65-69 Gy to the prostate and seminal vesicles, 45 Gy to the pelvic nodes). The primary endpoint was overall survival. The results presented here are of an interim analysis planned for when two-thirds of the events for the final analysis were recorded. All efficacy analyses were done by intention to treat and were based on data from all patients. This trial is registered at controlledtrials.com as ISRCTN24991896 and Clinicaltrials.gov as NCT00002633.
**RESULTS:** Between 1995 and 2005, 1205 patients were randomly assigned (602 in the ADT only group and 603 in the ADT and RT group); median follow-up was 6·0 years (IQR 4·4-8·0). At the time of analysis, a total of 320 patients had died, 175 in the ADT only group and 145 in the ADT and RT group. The addition of RT to ADT improved overall survival at 7 years (74%, 95% CI 70-78 vs 66%, 60-70; hazard ratio [HR] 0·77, 95% CI 0·61-0·98, p=0·033). Both toxicity and health-related quality-of-life results showed a small effect of RT on late gastrointestinal toxicity (rectal bleeding grade &gt;3, three patients (0·5%) in the ADT only group, two (0·3%) in the ADT and RT group; diarrhoea grade &gt;3, four patients (0·7%) vs eight (1·3%); urinary toxicity grade &gt;3, 14 patients (2·3%) in both groups).
**INTERPRETATION:** The benefits of combined modality treatment--ADT and RT--should be discussed with all patients with locally advanced prostate cancer.
**FUNDING:** Canadian Cancer Society Research Institute, US National Cancer Institute, and UK Medical Research Council."/>
<copyright value="Copyright © 2011 Elsevier Ltd. All rights reserved."/>
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<display value="Clinical Trial, Phase III"/>
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<coding>
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<display value="Journal Article"/>
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<coding>
<system value="https://meshb.nlm.nih.gov/"/>
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<classifier>
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<system value="https://meshb.nlm.nih.gov/"/>
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<coding>
<system
value="http://hl7.org/fhir/cited-artifact-classification-type"/>
<code value="knowledge-artifact-type"/>
<display value="Knowledge Artifact Type"/>
<userSelected value="false"/>
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</type>
<classifier>
<coding>
<system value="http://hl7.org/fhir/citation-artifact-classifier"/>
<code value="D016428"/>
<display value="Journal Article"/>
<userSelected value="false"/>
</coding>
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<artifactAssessment>
<display value="Classifier added by Computable Publishing LLC"/>
</artifactAssessment>
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<system
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<code value="citation-subset"/>
<display value="Citation subset"/>
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</coding>
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<coding>
<system
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<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="Warde P"/>
</contributor>
<forenameInitials value="P"/>
<affiliation>
<display
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<display value="Mason M"/>
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<entry>
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<entry>
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<contributor>
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<type value="Practitioner"/>
<display value="Brundage M"/>
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<contributor>
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<display value="Cowan R"/>
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<display value="Barber J"/>
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<forenameInitials value="J"/>
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<entry>
<contributor>
<reference value="#contributor11"/>
<type value="Practitioner"/>
<display value="Hiltz A"/>
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<forenameInitials value="A"/>
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<entry>
<contributor>
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<type value="Practitioner"/>
<display value="Parmar MK"/>
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<forenameInitials value="MK"/>
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<type value="Practitioner"/>
<display value="Sathya J"/>
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<forenameInitials value="J"/>
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<entry>
<contributor>
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<type value="Practitioner"/>
<display value="Anderson J"/>
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<forenameInitials value="J"/>
</entry>
<entry>
<contributor>
<reference value="#contributor15"/>
<type value="Practitioner"/>
<display value="Hayter C"/>
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<forenameInitials value="C"/>
</entry>
<entry>
<contributor>
<reference value="#contributor16"/>
<type value="Practitioner"/>
<display value="Hetherington J"/>
</contributor>
<forenameInitials value="J"/>
</entry>
<entry>
<contributor>
<reference value="#contributor17"/>
<type value="Practitioner"/>
<display value="Sydes MR"/>
</contributor>
<forenameInitials value="MR"/>
</entry>
<entry>
<contributor>
<reference value="#contributor18"/>
<type value="Practitioner"/>
<display value="Parulekar W"/>
</contributor>
<forenameInitials value="W"/>
</entry>
<entry>
<contributor>
<reference value="#contributor19"/>
<type value="Organization"/>
<display value="NCIC CTG PR.3/MRC UK PR07 investigators"/>
</contributor>
</entry>
</contributorship>
</citedArtifact>
</Citation>
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-11-21
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