Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 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-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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<div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><p class="res-header-id"><b>Generated Narrative: Citation 179623</b></p><a name="179623"> </a><a name="hc179623"> </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: 21; Last updated: 2025-10-13 12:34:35+0000; Language: en</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-journal-article-citation.html">JournalArticleCitation</a></p></div><p><b>ArtifactPublicationStatus</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}">Active</span></p><p><b>url</b>: <a href="https://fevir.net/resources/Citation/179623">https://fevir.net/resources/Citation/179623</a></p><p><b>identifier</b>: FEvIR Object Identifier/179623, <code>https://pubmed.ncbi.nlm.nih.gov</code>/23452809</p><p><b>title</b>: 23452809 Long-term follow-up of a phase II trial of chemotherapy plus hormone therapy for biochemical relapse after definitive local therapy for prostate cancer.</p><p><b>status</b>: Active</p><p><b>author</b>: Computable Publishing®: MEDLINE-to-FEvIR Converter: </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 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://terminology.hl7.org/7.1.0/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 medline-base}">Medline Base</span></td></tr></table><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>
</div><p><b>approvalDate</b>: 2013-04-22</p><p><b>lastReviewDate</b>: 2021-10-21</p><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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>: ?? --> 2012-11-21</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>: ?? --> 2012-12-14</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>: ?? --> 2012-12-18</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>: ?? --> 2013-03-05 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>: ?? --> 2013-03-05 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>: ?? --> 2013-04-23 06:00:00+0000</p></blockquote><blockquote><p><b>citedArtifact</b></p><p><b>identifier</b>: <code>https://pubmed.ncbi.nlm.nih.gov</code>/23452809, <code>https://doi.org</code>/10.1016/j.urology.2012.12.025, pii/S0090-4295(12)01569-5</p><h3>Titles</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://terminology.hl7.org/CodeSystem/title-type primary}">Primary title</span></td><td><div><p>Long-term follow-up of a phase II trial of chemotherapy plus hormone therapy for biochemical relapse after definitive local therapy for prostate cancer.</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><td><b>Copyright</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><div><p><strong>OBJECTIVE:</strong> To evaluate long-term follow-up of a phase II trial of chemohormonal therapy in 62 men with prostate cancer biochemical relapse (BR).
<strong>METHODS:</strong> Treatment was 4 cycles of docetaxel (70 mg/m(2)) every 3 weeks and estramustine 280 mg three times a day (days 1-5) followed by 15 months of goserelin acetate/bicalutamide. The primary endpoint was the proportion with prostate-specific antigen (PSA) <0.1 with recovered testosterone 5 years after completion of therapy. Secondary endpoints included time to progression (TTP), time to reinitiate androgen deprivation therapy (ADT), the proportion with castration-resistant prostate cancer (CRPC), and overall survival (OS).
<strong>RESULTS:</strong> Median follow-up was 8.6 years (range 1.3-11.1 years). At 5 year follow-up, 7 patients (11%) had PSA <0.1 (5 undetectable); 8 (13%) had PSA >0.1 but without reinitiation of ADT (median PSA 0.37). Of the 15 (24%) men without reinitiation of ADT, and 14 have recovered testosterone to normal range. Median TTP for the complete cohort was 35.0 months (95% confidence interval [CI] 31.7-39.2). Baseline PSA <3.0 ng/dL, no prior ADT, and prostatectomy (vs radiation) were associated with longer TTP (P = .0001, P = .0055, and P = .0398, respectively). At the time of analysis, 42 men (68%) had restarted ADT, 23 men had CRPC (37%), and 11 (18%) had chemotherapy. Median time to reinitiation of ADT was 32.6 months (range 0-107.6 months). Median OS has not been reached; there were 15 deaths.
<strong>CONCLUSION:</strong> Chemotherapy plus ADT for BR resulted in durable (>5 years) complete responses (<0.1 ng/mL) in 7 men (11%). Twenty-four percent of men have not re-initiated ADT 5 years from completion of protocol therapy.</p>
</div></td><td><div><p>Copyright © 2013 Elsevier Inc. All rights reserved.</p>
</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>Citation</b></td><td><b>Target[x]</b></td></tr><tr><td style="display: none">*</td><td>Has Comment In</td><td><span title="Codes:{https://www.nlm.nih.gov/mesh D016420}">Comment</span></td><td><div><p>J Urol. 2013 Sep;190(3):880. doi: 10.1016/j.juro.2013.05.105.</p>
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true</p><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179623/contributor0">Nakabayashi M</a></p><p><b>forenameInitials</b>: M</p><p><b>affiliation</b>: Division of Medical Oncology, Department of Medicine, Lank Center for Genitourinary Oncology, Boston, MA 02215, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179623/contributor1">Xie W</a></p><p><b>forenameInitials</b>: W</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179623/contributor2">Buckle G</a></p><p><b>forenameInitials</b>: G</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179623/contributor3">Bubley G</a></p><p><b>forenameInitials</b>: G</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179623/contributor4">Ernstoff MS</a></p><p><b>forenameInitials</b>: MS</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179623/contributor5">Walsh 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D000813}">Anilides</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:">is not a major topic</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh Q000627}">therapeutic use</span></p><h3>Components</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:">is Major topic</span></td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C49488}">Yes</span></td></tr></table></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier 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**METHODS:** Treatment was 4 cycles of docetaxel (70 mg/m(2)) every 3 weeks and estramustine 280 mg three times a day (days 1-5) followed by 15 months of goserelin acetate/bicalutamide. The primary endpoint was the proportion with prostate-specific antigen (PSA) &lt;0.1 with recovered testosterone 5 years after completion of therapy. Secondary endpoints included time to progression (TTP), time to reinitiate androgen deprivation therapy (ADT), the proportion with castration-resistant prostate cancer (CRPC), and overall survival (OS).
**RESULTS:** Median follow-up was 8.6 years (range 1.3-11.1 years). At 5 year follow-up, 7 patients (11%) had PSA &lt;0.1 (5 undetectable); 8 (13%) had PSA &gt;0.1 but without reinitiation of ADT (median PSA 0.37). Of the 15 (24%) men without reinitiation of ADT, and 14 have recovered testosterone to normal range. Median TTP for the complete cohort was 35.0 months (95% confidence interval [CI] 31.7-39.2). Baseline PSA &lt;3.0 ng/dL, no prior ADT, and prostatectomy (vs radiation) were associated with longer TTP (P = .0001, P = .0055, and P = .0398, respectively). At the time of analysis, 42 men (68%) had restarted ADT, 23 men had CRPC (37%), and 11 (18%) had chemotherapy. Median time to reinitiation of ADT was 32.6 months (range 0-107.6 months). Median OS has not been reached; there were 15 deaths.
**CONCLUSION:** Chemotherapy plus ADT for BR resulted in durable (&gt;5 years) complete responses (&lt;0.1 ng/mL) in 7 men (11%). Twenty-four percent of men have not re-initiated ADT 5 years from completion of protocol therapy."/>
<copyright value="Copyright © 2013 Elsevier Inc. All rights reserved."/>
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