SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Identifieur interne : 002A65 ( Istex/Corpus ); précédent : 002A64; suivant : 002A66SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Auteurs : An-Wen Chan ; Jennifer M. Tetzlaff ; Peter C. G Tzsche ; Douglas G. Altman ; Howard Mann ; Jesse A. Berlin ; Kay Dickersin ; Asbj Rn Hr Bjartsson ; Kenneth F. Schulz ; Wendy R. Parulekar ; Karmela Krleža-Jeri ; Andreas Laupacis ; David MoherSource :
- BMJ : British Medical Journal [ 0959-8138 ] ; 2013-01-09.
Abstract
High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
Url:
DOI: 10.1136/bmj.e7586
Links to Exploration step
ISTEX:11A5386270680F153EFFFD9165BBCF0F02405C42Le document en format XML
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Tetzlaff</name><affiliation><mods:affiliation>Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada</mods:affiliation></affiliation></author><author><name sortKey="G Tzsche, Peter C" sort="G Tzsche, Peter C" uniqKey="G Tzsche P" first="Peter C" last="G Tzsche">Peter C. G Tzsche</name><affiliation><mods:affiliation>Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark</mods:affiliation></affiliation></author><author><name sortKey="Altman, Douglas G" sort="Altman, Douglas G" uniqKey="Altman D" first="Douglas G" last="Altman">Douglas G. 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Schulz</name><affiliation><mods:affiliation>Quantitative Sciences, FHI 360, Research Triangle Park, USA</mods:affiliation></affiliation></author><author><name sortKey="Parulekar, Wendy R" sort="Parulekar, Wendy R" uniqKey="Parulekar W" first="Wendy R" last="Parulekar">Wendy R. Parulekar</name><affiliation><mods:affiliation>NCIC Clinical Trials Group, Cancer Research Institute, Queen’s University, Kingston, Canada</mods:affiliation></affiliation></author><author><name sortKey="Krleza Jeri, Karmela" sort="Krleza Jeri, Karmela" uniqKey="Krleza Jeri K" first="Karmela" last="Krleža-Jeri">Karmela Krleža-Jeri</name><affiliation><mods:affiliation>Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada</mods:affiliation></affiliation></author><author><name sortKey="Laupacis, Andreas" sort="Laupacis, Andreas" uniqKey="Laupacis A" first="Andreas" last="Laupacis">Andreas Laupacis</name><affiliation><mods:affiliation>Keenan Research Centre at the Li Ka Shing Knowledge Institute of St Michael’s Hospital, Faculty of Medicine, University of Toronto, Toronto, Canada</mods:affiliation></affiliation></author><author><name sortKey="Moher, David" sort="Moher, David" uniqKey="Moher D" first="David" last="Moher">David Moher</name><affiliation><mods:affiliation>Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">BMJ : British Medical Journal</title><title level="j" type="abbrev">BMJ</title><idno type="ISSN">0959-8138</idno><idno type="eISSN">1756-1833</idno><imprint><publisher>British Medical Journal Publishing Group</publisher><date type="published" when="2013-01-09">2013-01-09</date><biblScope unit="volume">346</biblScope></imprint><idno type="ISSN">0959-8138</idno></series><idno type="istex">11A5386270680F153EFFFD9165BBCF0F02405C42</idno><idno type="DOI">10.1136/bmj.e7586</idno><idno type="href">bmj-346-bmj-e7586.pdf</idno><idno type="ArticleID">chaa006386</idno><idno type="local">bmj;346/jan08_15/e7586</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0959-8138</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.</div></front></TEI><istex><corpusName>bmj</corpusName><author><json:item><name>An-Wen Chan</name><affiliations><json:string>Women’s College Research Institute at Women’s College Hospital, Department of Medicine, University of Toronto, Toronto, Canada, M5G 1N8</json:string><json:string>E-mail: anwen.chan@utoronto.ca</json:string></affiliations></json:item><json:item><name>Jennifer M Tetzlaff</name><affiliations><json:string>Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada</json:string></affiliations></json:item><json:item><name>Peter C Gøtzsche</name><affiliations><json:string>Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark</json:string></affiliations></json:item><json:item><name>Douglas G Altman</name><affiliations><json:string>Centre for Statistics in Medicine, University of Oxford, Oxford, UK</json:string></affiliations></json:item><json:item><name>Howard Mann</name><affiliations><json:string>Division of Medical Ethics and Humanities, University of Utah School of Medicine, Salt Lake City, USA</json:string></affiliations></json:item><json:item><name>Jesse A Berlin</name><affiliations><json:string>Janssen Research and Development, Titusville, USA</json:string></affiliations></json:item><json:item><name>Kay Dickersin</name><affiliations><json:string>Center for Clinical Trials, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA</json:string></affiliations></json:item><json:item><name>Asbjørn Hróbjartsson</name><affiliations><json:string>Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark</json:string></affiliations></json:item><json:item><name>Kenneth F Schulz</name><affiliations><json:string>Quantitative Sciences, FHI 360, Research Triangle Park, USA</json:string></affiliations></json:item><json:item><name>Wendy R Parulekar</name><affiliations><json:string>NCIC Clinical Trials Group, Cancer Research Institute, Queen’s University, Kingston, Canada</json:string></affiliations></json:item><json:item><name>Karmela Krleža-Jerić</name><affiliations><json:string>Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada</json:string></affiliations></json:item><json:item><name>Andreas Laupacis</name><affiliations><json:string>Keenan Research Centre at the Li Ka Shing Knowledge Institute of St Michael’s Hospital, Faculty of Medicine, University of Toronto, Toronto, Canada</json:string></affiliations></json:item><json:item><name>David Moher</name><affiliations><json:string>Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada</json:string><json:string>Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada</json:string></affiliations></json:item></author><articleId><json:string>chaa006386</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>other</json:string></originalGenre><abstract>High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.</abstract><qualityIndicators><score>7.552</score><pdfWordCount>40084</pdfWordCount><pdfCharCount>266485</pdfCharCount><pdfVersion>1.4</pdfVersion><pdfPageCount>42</pdfPageCount><pdfPageSize>595 x 842 pts (A4)</pdfPageSize><refBibsNative>false</refBibsNative><abstractWordCount>171</abstractWordCount><abstractCharCount>1234</abstractCharCount><keywordCount>0</keywordCount></qualityIndicators><title>SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials</title><genre><json:string>other</json:string></genre><host><title>BMJ : British Medical 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The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.</p></abstract></profileDesc><revisionDesc><change when="2013-01-09">Created</change><change when="2013-01-09">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api-v5.istex.fr/document/11A5386270680F153EFFFD9165BBCF0F02405C42/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus bmj" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="no"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Archiving and Interchange DTD v2.3 20070202//EN" URI="archivearticle.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="other"><front><journal-meta><journal-id journal-id-type="hwp">bmj</journal-id><journal-id journal-id-type="nlm-ta">BMJ</journal-id><journal-id journal-id-type="publisher-id">bmj</journal-id><journal-title>BMJ : British Medical Journal</journal-title><issn pub-type="epub">1756-1833</issn><publisher><publisher-name>British Medical Journal Publishing Group</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">chaa006386</article-id><article-id pub-id-type="doi">10.1136/bmj.e7586</article-id><article-id pub-id-type="other">bmj;346/jan08_15/e7586</article-id><article-id pub-id-type="other">bmj;bmj.e7586</article-id><article-id pub-id-type="other">jan08_15</article-id><article-id pub-id-type="other">bmj.e7586</article-id><article-id pub-id-type="other">bmj.e7586</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Methods & Reporting</subject></subj-group></article-categories><title-group><article-title>SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Chan</surname><given-names>An-Wen</given-names></name><role>Phelan scientist</role><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Tetzlaff</surname><given-names>Jennifer M</given-names></name><role>research coordinator</role><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Gøtzsche</surname><given-names>Peter C</given-names></name><role>professor and director</role><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Altman</surname><given-names>Douglas G</given-names></name><role>professor and director</role><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Mann</surname><given-names>Howard</given-names></name><role>programme associate</role><xref ref-type="aff" rid="aff5">5</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Berlin</surname><given-names>Jesse A</given-names></name><role>vice president, epidemiology</role><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Dickersin</surname><given-names>Kay</given-names></name><role>professor and director</role><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Hróbjartsson</surname><given-names>Asbjørn</given-names></name><role>senior researcher</role><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Schulz</surname><given-names>Kenneth F</given-names></name><role>distinguished scientist</role><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Parulekar</surname><given-names>Wendy R</given-names></name><role>associate professor</role><xref ref-type="aff" rid="aff9">9</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Krleža-Jerić</surname><given-names>Karmela</given-names></name><role>adjunct professor</role><xref ref-type="aff" rid="aff10">10</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Laupacis</surname><given-names>Andreas</given-names></name><role>professor</role><xref ref-type="aff" rid="aff11">11</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Moher</surname><given-names>David</given-names></name><role>senior scientist</role><xref ref-type="aff" rid="aff2">2</xref><xref ref-type="aff" rid="aff10">10</xref></contrib><aff id="aff1"><label>1</label>Women’s College Research Institute at Women’s College Hospital, Department of Medicine, University of Toronto, Toronto, Canada, M5G 1N8</aff><aff id="aff2"><label>2</label>Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada</aff><aff id="aff3"><label>3</label>Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark</aff><aff id="aff4"><label>4</label>Centre for Statistics in Medicine, University of Oxford, Oxford, UK</aff><aff id="aff5"><label>5</label>Division of Medical Ethics and Humanities, University of Utah School of Medicine, Salt Lake City, USA</aff><aff id="aff6"><label>6</label>Janssen Research and Development, Titusville, USA</aff><aff id="aff7"><label>7</label>Center for Clinical Trials, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA</aff><aff id="aff8"><label>8</label>Quantitative Sciences, FHI 360, Research Triangle Park, USA</aff><aff id="aff9"><label>9</label>NCIC Clinical Trials Group, Cancer Research Institute, Queen’s University, Kingston, Canada</aff><aff id="aff10"><label>10</label>Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada</aff><aff id="aff11"><label>11</label>Keenan Research Centre at the Li Ka Shing Knowledge Institute of St Michael’s Hospital, Faculty of Medicine, University of Toronto, Toronto, Canada</aff></contrib-group><author-notes><corresp>Correspondence to: A-W Chan <email>anwen.chan@utoronto.ca</email></corresp></author-notes><pub-date pub-type="collection"><year>2013</year></pub-date><pub-date pub-type="epub-original"><day>9</day><month>1</month><year>2013</year></pub-date><pub-date pub-type="epub"><day>9</day><month>1</month><year>2013</year></pub-date><volume>346</volume><volume-id pub-id-type="other">346</volume-id><volume-id pub-id-type="other">346</volume-id><elocation-id>e7586</elocation-id><history><date date-type="accepted"><day>4</day><month>October</month><year>2012</year></date></history><permissions><copyright-statement>© Chan et al 2013</copyright-statement><copyright-year>2013</copyright-year><copyright-holder>Chan et al</copyright-holder><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/"><p>This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: <ext-link xlink:href="http://creativecommons.org/licenses/by-nc/2.0/" ext-link-type="uri">http://creativecommons.org/licenses/by-nc/2.0/</ext-link> and <ext-link xlink:href="http://creativecommons.org/licenses/by-nc/2.0/legalcode" ext-link-type="uri">http://creativecommons.org/licenses/by-nc/2.0/legalcode</ext-link>.</p></license></permissions><self-uri content-type="pdf" xlink:role="full-text" xlink:href="bmj-346-bmj-e7586.pdf"></self-uri><abstract><p>High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol.</p><p> This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (<ext-link xlink:href="http://www.spirit-statement.org/" ext-link-type="uri" xlink:type="simple">www.spirit-statement.org</ext-link>).</p><p>The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.</p></abstract></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo><title>SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials</title></titleInfo><titleInfo type="alternative" contentType="CDATA"><title>SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials</title></titleInfo><name type="personal" displayLabel="corresp"><namePart type="given">An-Wen</namePart><namePart type="family">Chan</namePart><affiliation>Women’s College Research Institute at Women’s College Hospital, Department of Medicine, University of Toronto, Toronto, Canada, M5G 1N8</affiliation><affiliation>E-mail: anwen.chan@utoronto.ca</affiliation><description>Phelan scientist</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jennifer M</namePart><namePart type="family">Tetzlaff</namePart><affiliation>Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada</affiliation><description>research coordinator</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Peter C</namePart><namePart type="family">Gøtzsche</namePart><affiliation>Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark</affiliation><description>professor and director</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Douglas G</namePart><namePart type="family">Altman</namePart><affiliation>Centre for Statistics in Medicine, University of Oxford, Oxford, UK</affiliation><description>professor and director</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Howard</namePart><namePart type="family">Mann</namePart><affiliation>Division of Medical Ethics and Humanities, University of Utah School of Medicine, Salt Lake City, USA</affiliation><description>programme associate</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jesse A</namePart><namePart type="family">Berlin</namePart><affiliation>Janssen Research and Development, Titusville, USA</affiliation><description>vice president, epidemiology</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Kay</namePart><namePart type="family">Dickersin</namePart><affiliation>Center for Clinical Trials, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA</affiliation><description>professor and director</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Asbjørn</namePart><namePart type="family">Hróbjartsson</namePart><affiliation>Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark</affiliation><description>senior researcher</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Kenneth F</namePart><namePart type="family">Schulz</namePart><affiliation>Quantitative Sciences, FHI 360, Research Triangle Park, USA</affiliation><description>distinguished scientist</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Wendy R</namePart><namePart type="family">Parulekar</namePart><affiliation>NCIC Clinical Trials Group, Cancer Research Institute, Queen’s University, Kingston, Canada</affiliation><description>associate professor</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Karmela</namePart><namePart type="family">Krleža-Jerić</namePart><affiliation>Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada</affiliation><description>adjunct professor</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Andreas</namePart><namePart type="family">Laupacis</namePart><affiliation>Keenan Research Centre at the Li Ka Shing Knowledge Institute of St Michael’s Hospital, Faculty of Medicine, University of Toronto, Toronto, Canada</affiliation><description>professor</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">David</namePart><namePart type="family">Moher</namePart><affiliation>Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada</affiliation><affiliation>Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada</affiliation><description>senior scientist</description><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="other" displayLabel="other"></genre><originInfo><publisher>British Medical Journal Publishing Group</publisher><dateIssued encoding="w3cdtf">2013-01-09</dateIssued><dateCreated encoding="w3cdtf">2013-01-09</dateCreated><copyrightDate encoding="w3cdtf">2013</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract>High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.</abstract><relatedItem type="host"><titleInfo><title>BMJ : British Medical Journal</title></titleInfo><titleInfo type="abbreviated"><title>BMJ</title></titleInfo><genre type="journal">journal</genre><identifier type="ISSN">0959-8138</identifier><identifier type="eISSN">1756-1833</identifier><identifier type="PublisherID">bmj</identifier><identifier type="PublisherID-hwp">bmj</identifier><identifier type="PublisherID-nlm-ta">BMJ</identifier><part><date>2013</date><detail type="volume"><caption>vol.</caption><number>346</number></detail></part></relatedItem><identifier type="istex">11A5386270680F153EFFFD9165BBCF0F02405C42</identifier><identifier type="DOI">10.1136/bmj.e7586</identifier><identifier type="href">bmj-346-bmj-e7586.pdf</identifier><identifier type="ArticleID">chaa006386</identifier><identifier type="local">bmj;346/jan08_15/e7586</identifier><accessCondition type="use and reproduction" contentType="open-access">This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.</accessCondition><recordInfo><recordContentSource>BMJ</recordContentSource><recordOrigin>Chan et al</recordOrigin></recordInfo></mods></metadata><annexes><json:item><extension>jpeg</extension><original>true</original><mimetype>image/jpeg</mimetype><uri>https://api-v5.istex.fr/document/11A5386270680F153EFFFD9165BBCF0F02405C42/annexes/jpeg</uri></json:item></annexes><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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