SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Identifieur interne : 000141 ( Main/Exploration ); précédent : 000140; suivant : 000142SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Auteurs : An Chan [Canada] ; Jennifer. Tetzlaff [Canada] ; Peter. G [Danemark] ; Douglas. Altman [Royaume-Uni] ; Howard Mann [États-Unis] ; Jesse. Berlin [États-Unis] ; Kay Dickersin [États-Unis] ; Asbj Hr [Danemark] ; Kenneth. Schulz [États-Unis] ; Wendy. Parulekar [Canada] ; Karmela Krleža [Canada] ; Andreas Laupacis [Canada] ; David Moher [Canada]Source :
- BMJ : British Medical Journal [ 1756-1833 ] ; 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
Affiliations:
- Canada, Danemark, Royaume-Uni, États-Unis
- Angleterre, Hovedstaden, Maryland, Ontario, Oxfordshire
- Baltimore, Copenhague, Oxford, Toronto
- Université d'Oxford, Université de Toronto
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Berlin</name><affiliation wicri:level="1"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Janssen Research and Development, Titusville</wicri:regionArea><wicri:noRegion>Titusville</wicri:noRegion></affiliation></author><author><name sortKey="Dickersin, Kay" sort="Dickersin, Kay" uniqKey="Dickersin K" first="Kay" last="Dickersin">Kay Dickersin</name><affiliation wicri:level="3"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Center for Clinical Trials, Johns Hopkins Bloomberg School of Public Health, Baltimore</wicri:regionArea><placeName><settlement type="city">Baltimore</settlement><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Hr Bjartsson, Asbj Rn" sort="Hr Bjartsson, Asbj Rn" uniqKey="Hr Bjartsson A" first="Asbj" last="Hr">Asbj Hr</name><affiliation wicri:level="3"><country xml:lang="fr">Danemark</country><wicri:regionArea>Nordic Cochrane Centre, Rigshospitalet, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Schulz, Kenneth F" sort="Schulz, Kenneth F" uniqKey="Schulz K" first="Kenneth" last="Schulz">Kenneth. 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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><affiliations><list><country><li>Canada</li><li>Danemark</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Hovedstaden</li><li>Maryland</li><li>Ontario</li><li>Oxfordshire</li></region><settlement><li>Baltimore</li><li>Copenhague</li><li>Oxford</li><li>Toronto</li></settlement><orgName><li>Université d'Oxford</li><li>Université de Toronto</li></orgName></list><tree><country name="Canada"><noRegion><name sortKey="Chan, An Wen" sort="Chan, An Wen" uniqKey="Chan A" first="An" last="Chan">An Chan</name></noRegion><name sortKey="Krleza Jeri, Karmela" sort="Krleza Jeri, Karmela" uniqKey="Krleza Jeri K" first="Karmela" last="Krleža">Karmela Krleža</name><name sortKey="Laupacis, Andreas" sort="Laupacis, Andreas" uniqKey="Laupacis A" first="Andreas" last="Laupacis">Andreas Laupacis</name><name sortKey="Moher, David" sort="Moher, David" uniqKey="Moher D" first="David" last="Moher">David Moher</name><name sortKey="Moher, David" sort="Moher, David" uniqKey="Moher D" first="David" last="Moher">David Moher</name><name sortKey="Parulekar, Wendy R" sort="Parulekar, Wendy R" uniqKey="Parulekar W" first="Wendy" last="Parulekar">Wendy. Parulekar</name><name sortKey="Tetzlaff, Jennifer M" sort="Tetzlaff, Jennifer M" uniqKey="Tetzlaff J" first="Jennifer" last="Tetzlaff">Jennifer. Tetzlaff</name></country><country name="Danemark"><region name="Hovedstaden"><name sortKey="G Tzsche, Peter C" sort="G Tzsche, Peter C" uniqKey="G Tzsche P" first="Peter" last="G">Peter. G</name></region><name sortKey="Hr Bjartsson, Asbj Rn" sort="Hr Bjartsson, Asbj Rn" uniqKey="Hr Bjartsson A" first="Asbj" last="Hr">Asbj Hr</name></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Altman, Douglas G" sort="Altman, Douglas G" uniqKey="Altman D" first="Douglas" last="Altman">Douglas. Altman</name></region></country><country name="États-Unis"><noRegion><name sortKey="Mann, Howard" sort="Mann, Howard" uniqKey="Mann H" first="Howard" last="Mann">Howard Mann</name></noRegion><name sortKey="Berlin, Jesse A" sort="Berlin, Jesse A" uniqKey="Berlin J" first="Jesse" last="Berlin">Jesse. Berlin</name><name sortKey="Dickersin, Kay" sort="Dickersin, Kay" uniqKey="Dickersin K" first="Kay" last="Dickersin">Kay Dickersin</name><name sortKey="Schulz, Kenneth F" sort="Schulz, Kenneth F" uniqKey="Schulz K" first="Kenneth" last="Schulz">Kenneth. Schulz</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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