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 179630</b></p><a name="179630"> </a><a name="hc179630"> </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: 19; 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/179630">https://fevir.net/resources/Citation/179630</a></p><p><b>identifier</b>: FEvIR Object Identifier/179630, <code>https://pubmed.ncbi.nlm.nih.gov</code>/26092557</p><p><b>title</b>: 26092557 Feasibility study of a randomized controlled trial comparing docetaxel chemotherapy and androgen deprivation therapy with sequential prostatic biopsies from patients with advanced non-castration-resistant 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>
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</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>BACKGROUND AND OBJECTIVE:</strong> Sequential tissue biopsies taken during clinical trials of novel systemic anticancer therapies for advanced prostate cancer (PCa) may aid pharmacodynamic evaluation and biomarker discovery. We conducted a single institution phase-II open-labeled randomized study to assess the safety, tolerability, and early efficacy of docetaxel chemotherapy plus androgen deprivation therapy (ADT) vs. ADT alone for patients with advanced non-castration-resistant PCa with sequential prostatic biopsies.
<strong>PATIENTS AND METHODS:</strong> We randomized 30 patients with newly diagnosed high-grade locally advanced or metastatic (cT3-4/N0-1/M0-1) PCa to receive ADT with (n = 15) or without (n = 15) docetaxel. Transrectal ultrasound-guided prostatic biopsies were taken at randomization and ~22 weeks after treatment initiation. Primary end point: biochemical response rate. Secondary end points: time to progression and tumor profiling.
<strong>RESULTS:</strong> Both treatments appear to be well tolerated, and there was no difference in mean nadir prostate-specific antigen and time to prostate-specific antigen relapse between treatment arms (P>0.05). No adverse effects of pre- and post-treatment prostatic biopsies were observed. The study was neither designed nor sufficiently powered to demonstrate statistically significant differences in oncological outcomes or safety profiles between the 2 treatment arms.
<strong>CONCLUSIONS:</strong> Despite the lack of statistical power, our study suggests that docetaxel and ADT in combination may be well tolerated with apparently similar short-term efficacy compared with ADT alone for high-grade locally advanced or metastatic non-castration-resistant PCa, Sequential prostatic biopsies may provide tissue for tumor profiling to yield mechanistic or prognostic insights relating to novel systemic anticancer therapies.</p>
</div></td><td><div><p>Copyright © 2015 Elsevier Inc. All rights reserved.</p>
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Electronic address: h.leung@beatson.gla.ac.uk.</p></blockquote></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: ArtifactAssessment #keywords0</b></p><a name="179630/keywords0"> </a><a name="hc179630/keywords0"> </a><p><b>artifact</b>: <a href="#hc179630">Citation 26092557 Feasibility study of a randomized controlled trial comparing docetaxel chemotherapy and androgen deprivation therapy with sequential prostatic biopsies from patients with advanced non-castration-resistant prostate cancer.</a></p><blockquote><p><b>content</b></p><p><b>classifier</b>: <span title="Codes:">Androgen deprivation therapy</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: <span title="Codes:">Docetaxel</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: <span title="Codes:">Prostate cancer</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: <span title="Codes:">Prostatic 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**PATIENTS AND METHODS:** We randomized 30 patients with newly diagnosed high-grade locally advanced or metastatic (cT3-4/N0-1/M0-1) PCa to receive ADT with (n = 15) or without (n = 15) docetaxel. Transrectal ultrasound-guided prostatic biopsies were taken at randomization and ~22 weeks after treatment initiation. Primary end point: biochemical response rate. Secondary end points: time to progression and tumor profiling.
**RESULTS:** Both treatments appear to be well tolerated, and there was no difference in mean nadir prostate-specific antigen and time to prostate-specific antigen relapse between treatment arms (P&gt;0.05). No adverse effects of pre- and post-treatment prostatic biopsies were observed. The study was neither designed nor sufficiently powered to demonstrate statistically significant differences in oncological outcomes or safety profiles between the 2 treatment arms.
**CONCLUSIONS:** Despite the lack of statistical power, our study suggests that docetaxel and ADT in combination may be well tolerated with apparently similar short-term efficacy compared with ADT alone for high-grade locally advanced or metastatic non-castration-resistant PCa, Sequential prostatic biopsies may provide tissue for tumor profiling to yield mechanistic or prognostic insights relating to novel systemic anticancer therapies."/>
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IG © 2024+ HL7 International / Clinical Decision Support.
Package hl7.fhir.uv.ebm#1.0.0-ballot3 based on FHIR 6.0.0-ballot3.
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2026-03-27
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