Poor patient-reported outcomes reporting according to CONSORT guidelines in randomized clinical trials evaluating systemic cancer therapy.
Identifieur interne : 003132 ( PubMed/Corpus ); précédent : 003131; suivant : 003133Poor patient-reported outcomes reporting according to CONSORT guidelines in randomized clinical trials evaluating systemic cancer therapy.
Auteurs : O. Bylicki ; H K Gan ; F. Joly ; D. Maillet ; B. You ; J. PéronSource :
- Annals of oncology : official journal of the European Society for Medical Oncology [ 1569-8041 ] ; 2015.
English descriptors
- KwdEn :
- MESH :
- drug therapy : Neoplasms.
- standards : Medical Oncology, Research Design.
- Humans, Patient Outcome Assessment, Quality of Life, Randomized Controlled Trials as Topic, Self Report.
Abstract
The Consolidated Standards of Reporting Trials (CONSORT) guidance was extended in 2013 to provide a set of specific recommendations regarding patient-reported outcomes (PROs) reporting in randomized clinical trials (RCTs). There is limited data regarding how well current publications of oncology RCTs report PROs if assessed using these guidelines.
DOI: 10.1093/annonc/mdu489
PubMed: 25355720
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Poor patient-reported outcomes reporting according to CONSORT guidelines in randomized clinical trials evaluating systemic cancer therapy.</title><author><name sortKey="Bylicki, O" sort="Bylicki, O" uniqKey="Bylicki O" first="O" last="Bylicki">O. Bylicki</name><affiliation><nlm:affiliation>Department of Pneumology, Desgenettes Hospital Department of Medical Oncology, Centre Léon BERARD, University of Lyon, Lyon, France.</nlm:affiliation></affiliation></author><author><name sortKey="Gan, H K" sort="Gan, H K" uniqKey="Gan H" first="H K" last="Gan">H K Gan</name><affiliation><nlm:affiliation>Joint Austin-Ludwig Oncology Unit, Austin Hospital, Melbourne, Victoria, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Joly, F" sort="Joly, F" uniqKey="Joly F" first="F" last="Joly">F. Joly</name><affiliation><nlm:affiliation>INSERM, U1086, Caen Clinical Research Unit, François Baclesse Center, Caen Department of Medicine, CHU de Caen, Caen.</nlm:affiliation></affiliation></author><author><name sortKey="Maillet, D" sort="Maillet, D" uniqKey="Maillet D" first="D" last="Maillet">D. Maillet</name><affiliation><nlm:affiliation>Department of Medical Oncology, Lyon-Sud Hospital Center, Hospices Civils de Lyon, Pierre-Bénite.</nlm:affiliation></affiliation></author><author><name sortKey="You, B" sort="You, B" uniqKey="You B" first="B" last="You">B. You</name><affiliation><nlm:affiliation>Department of Medical Oncology, Lyon-Sud Hospital Center, Hospices Civils de Lyon, Pierre-Bénite EMR UCBL/HCL 3738, Faculté de Médecine Lyon-Sud, Oullins Department of Medical Oncology, University of Lyon, Lyon.</nlm:affiliation></affiliation></author><author><name sortKey="Peron, J" sort="Peron, J" uniqKey="Peron J" first="J" last="Péron">J. Péron</name><affiliation><nlm:affiliation>Department of Medical Oncology, Lyon-Sud Hospital Center, Hospices Civils de Lyon, Pierre-Bénite Biostatistics Unit, Hospices Civils de Lyon, Lyon Biometry and Evolutionary Biology Laboratory, Health and Biostatistics Team, CNRS UMR 5558, Villeurbanne, France julien.peron@chu-lyon.fr.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:25355720</idno><idno type="pmid">25355720</idno><idno type="doi">10.1093/annonc/mdu489</idno><idno type="wicri:Area/PubMed/Corpus">003132</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">003132</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Poor patient-reported outcomes reporting according to CONSORT guidelines in randomized clinical trials evaluating systemic cancer therapy.</title><author><name sortKey="Bylicki, O" sort="Bylicki, O" uniqKey="Bylicki O" first="O" last="Bylicki">O. Bylicki</name><affiliation><nlm:affiliation>Department of Pneumology, Desgenettes Hospital Department of Medical Oncology, Centre Léon BERARD, University of Lyon, Lyon, France.</nlm:affiliation></affiliation></author><author><name sortKey="Gan, H K" sort="Gan, H K" uniqKey="Gan H" first="H K" last="Gan">H K Gan</name><affiliation><nlm:affiliation>Joint Austin-Ludwig Oncology Unit, Austin Hospital, Melbourne, Victoria, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Joly, F" sort="Joly, F" uniqKey="Joly F" first="F" last="Joly">F. Joly</name><affiliation><nlm:affiliation>INSERM, U1086, Caen Clinical Research Unit, François Baclesse Center, Caen Department of Medicine, CHU de Caen, Caen.</nlm:affiliation></affiliation></author><author><name sortKey="Maillet, D" sort="Maillet, D" uniqKey="Maillet D" first="D" last="Maillet">D. Maillet</name><affiliation><nlm:affiliation>Department of Medical Oncology, Lyon-Sud Hospital Center, Hospices Civils de Lyon, Pierre-Bénite.</nlm:affiliation></affiliation></author><author><name sortKey="You, B" sort="You, B" uniqKey="You B" first="B" last="You">B. You</name><affiliation><nlm:affiliation>Department of Medical Oncology, Lyon-Sud Hospital Center, Hospices Civils de Lyon, Pierre-Bénite EMR UCBL/HCL 3738, Faculté de Médecine Lyon-Sud, Oullins Department of Medical Oncology, University of Lyon, Lyon.</nlm:affiliation></affiliation></author><author><name sortKey="Peron, J" sort="Peron, J" uniqKey="Peron J" first="J" last="Péron">J. Péron</name><affiliation><nlm:affiliation>Department of Medical Oncology, Lyon-Sud Hospital Center, Hospices Civils de Lyon, Pierre-Bénite Biostatistics Unit, Hospices Civils de Lyon, Lyon Biometry and Evolutionary Biology Laboratory, Health and Biostatistics Team, CNRS UMR 5558, Villeurbanne, France julien.peron@chu-lyon.fr.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Annals of oncology : official journal of the European Society for Medical Oncology</title><idno type="eISSN">1569-8041</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Humans</term><term>Medical Oncology (standards)</term><term>Neoplasms (drug therapy)</term><term>Patient Outcome Assessment</term><term>Quality of Life</term><term>Randomized Controlled Trials as Topic</term><term>Research Design (standards)</term><term>Self Report</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Neoplasms</term></keywords><keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Medical Oncology</term><term>Research Design</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Humans</term><term>Patient Outcome Assessment</term><term>Quality of Life</term><term>Randomized Controlled Trials as Topic</term><term>Self Report</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The Consolidated Standards of Reporting Trials (CONSORT) guidance was extended in 2013 to provide a set of specific recommendations regarding patient-reported outcomes (PROs) reporting in randomized clinical trials (RCTs). There is limited data regarding how well current publications of oncology RCTs report PROs if assessed using these guidelines.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25355720</PMID><DateCreated><Year>2014</Year><Month>12</Month><Day>18</Day></DateCreated><DateCompleted><Year>2015</Year><Month>08</Month><Day>24</Day></DateCompleted><DateRevised><Year>2016</Year><Month>10</Month><Day>17</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1569-8041</ISSN><JournalIssue CitedMedium="Internet"><Volume>26</Volume><Issue>1</Issue><PubDate><Year>2015</Year><Month>Jan</Month></PubDate></JournalIssue><Title>Annals of oncology : official journal of the European Society for Medical Oncology</Title><ISOAbbreviation>Ann. Oncol.</ISOAbbreviation></Journal><ArticleTitle>Poor patient-reported outcomes reporting according to CONSORT guidelines in randomized clinical trials evaluating systemic cancer therapy.</ArticleTitle><Pagination><MedlinePgn>231-7</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1093/annonc/mdu489</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The Consolidated Standards of Reporting Trials (CONSORT) guidance was extended in 2013 to provide a set of specific recommendations regarding patient-reported outcomes (PROs) reporting in randomized clinical trials (RCTs). There is limited data regarding how well current publications of oncology RCTs report PROs if assessed using these guidelines.</AbstractText><AbstractText Label="DESIGN" NlmCategory="METHODS">All phase III medical oncology RCTs published between 2007 and 2011 were reviewed according to the 2013 PROs CONSORT recommendations and an 11-point PROs reporting quality score (PRORQS) was defined based on the criteria.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">The majority of trials did not report on PROs at all (201 of 325; 62%). Of the remaining 124 trials, the mean PRORQS score was 5.0 on an 11-point scale. The items related to methods of PROs collection and analysis were poorly reported (Description of the prespecified PRO hypothesis: 26% of RCTs; methods for PRO data collection (paper, telephone, electronic, other): 16%; statistical approaches for managing missing data: 37%). The only factor significantly associated with improved PROs reporting was where PROs reporting was the subject of a dedicated secondary manuscript, as was the case in 36 of the 124 (29%) of RCTs.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Despite their clinical relevance, our findings show that some aspects of PROs reporting may greatly be improved, especially critical methodological aspects of PROs collection and analysis. The exceptions were where PROs were described in PROs-specific secondary publication. Use of the 2013 PROs CONSORT extensions should be encouraged and their effects on PROs reporting subsequently reassessed.</AbstractText><CopyrightInformation>© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Bylicki</LastName><ForeName>O</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>Department of Pneumology, Desgenettes Hospital Department of Medical Oncology, Centre Léon BERARD, University of Lyon, Lyon, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gan</LastName><ForeName>H K</ForeName><Initials>HK</Initials><AffiliationInfo><Affiliation>Joint Austin-Ludwig Oncology Unit, Austin Hospital, Melbourne, Victoria, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Joly</LastName><ForeName>F</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>INSERM, U1086, Caen Clinical Research Unit, François Baclesse Center, Caen Department of Medicine, CHU de Caen, Caen.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Maillet</LastName><ForeName>D</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Department of Medical Oncology, Lyon-Sud Hospital Center, Hospices Civils de Lyon, Pierre-Bénite.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>You</LastName><ForeName>B</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Department of Medical Oncology, Lyon-Sud Hospital Center, Hospices Civils de Lyon, Pierre-Bénite EMR UCBL/HCL 3738, Faculté de Médecine Lyon-Sud, Oullins Department of Medical Oncology, University of Lyon, Lyon.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Péron</LastName><ForeName>J</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Medical Oncology, Lyon-Sud Hospital Center, Hospices Civils de Lyon, Pierre-Bénite Biostatistics Unit, Hospices Civils de Lyon, Lyon Biometry and Evolutionary Biology Laboratory, Health and Biostatistics Team, CNRS UMR 5558, Villeurbanne, France julien.peron@chu-lyon.fr.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>10</Month><Day>29</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Ann Oncol</MedlineTA><NlmUniqueID>9007735</NlmUniqueID><ISSNLinking>0923-7534</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008495" MajorTopicYN="N">Medical Oncology</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D009369" MajorTopicYN="N">Neoplasms</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D063868" MajorTopicYN="Y">Patient Outcome Assessment</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011788" MajorTopicYN="N">Quality of Life</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016032" MajorTopicYN="Y">Randomized Controlled Trials as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012107" MajorTopicYN="N">Research Design</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D057566" MajorTopicYN="Y">Self Report</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">patients-reported outcomes</Keyword><Keyword MajorTopicYN="N">quality of life</Keyword><Keyword MajorTopicYN="N">randomized clinical trials</Keyword><Keyword MajorTopicYN="N">reporting quality</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>10</Month><Day>31</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>10</Month><Day>31</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>8</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">25355720</ArticleId><ArticleId IdType="pii">mdu489</ArticleId><ArticleId IdType="doi">10.1093/annonc/mdu489</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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