Quality of Reporting of Modern Randomized Controlled Trials in Medical Oncology: A Systematic Review
Identifieur interne : 005973 ( Main/Exploration ); précédent : 005972; suivant : 005974Quality of Reporting of Modern Randomized Controlled Trials in Medical Oncology: A Systematic Review
Auteurs : Julien Peron [France] ; Gregory R. Pond [Canada] ; Hui K. Gan [Australie] ; Eric X. Chen [Canada] ; Roula Almufti [France] ; Denis Maillet [France] ; Benoit You [France]Source :
- Journal of the National Cancer Institute [ 0027-8874 ] ; 2012.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
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Abstract
Background The Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in the mid-1990s for the explicit purpose of improving clinical trial reporting. However, there is little information regarding the adherence to CONSORT guidelines of recent publications of randomized controlled trials (RCTs) in oncology. Methods All phase III RCTs published between 2005 and 2009 were reviewed using an 18-point overall quality score for reporting based on the 2001 CONSORT statement. Multivariable linear regression was used to identify features associated with improved reporting quality. To provide baseline data for future evaluations of reporting quality, RCTs were also assessed according to the 2010 revised CONSORT statement. All statistical tests were two-sided. Results A total of 357 RCTs were reviewed.The mean 2001 overall quality score was 13.4 on a scale of 0-18, whereas the mean 2010 overall quality score was 19.3 on a scale of 0-27. The overall RCT reporting quality score improved by 0.21 points per year from 2005 to 2009. Poorly reported items included method used to generate the random allocation (adequately reported in 29% of trials), whether and how blinding was applied (41%), method of allocation concealment (51%), and participant flow (59%). High impact factor (IF, P = .003), recent publication date (P = .008), and geographic origin of RCTs (P = .003) were independent factors statistically significantly associated with higher reporting quality in a multivariable regression model. Sample size, tumor type, and positivity of trial results were not associated with higher reporting quality, whereas funding source and treatment type had a borderline statistically significant impact. Conclusion The results show that numerous items remained unreported for many trials.Thus, given the potential impact of poorly reported trials, oncology journals should require even stricter adherence to the CONSORT guidelines.
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Pond</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Ontario Clinical Oncology Group, Department of Oncology, McMaster University</s1><s2>Hamilton, ON</s2><s3>CAN</s3><sZ>2 aut.</sZ></inist:fA14><country>Canada</country><placeName><settlement type="city">Hamilton (Ontario)</settlement><region type="state">Ontario</region></placeName><orgName type="university">Université McMaster</orgName></affiliation></author><author><name sortKey="Gan, Hui K" sort="Gan, Hui K" uniqKey="Gan H" first="Hui K." last="Gan">Hui K. Gan</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Joint Austin-Ludwig Oncology Unit, Austin Hospital</s1><s2>Melbourne, VIC</s2><s3>AUS</s3><sZ>3 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Melbourne, VIC</wicri:noRegion></affiliation></author><author><name sortKey="Chen, Eric X" sort="Chen, Eric X" uniqKey="Chen E" first="Eric X." last="Chen">Eric X. Chen</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Department of Medical Oncology and Hematology, Princess Margaret Hospital, University Health Network</s1><s2>Toronto, ON</s2><s3>CAN</s3><sZ>4 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Toronto, ON</wicri:noRegion></affiliation></author><author><name sortKey="Almufti, Roula" sort="Almufti, Roula" uniqKey="Almufti R" first="Roula" last="Almufti">Roula Almufti</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Service d'Oncologie Médicale, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon</s1><s2>Pierre-Bénite</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Pierre-Bénite</wicri:noRegion><wicri:noRegion>Hospices Civils de Lyon</wicri:noRegion><wicri:noRegion>Pierre-Bénite</wicri:noRegion></affiliation></author><author><name sortKey="Maillet, Denis" sort="Maillet, Denis" uniqKey="Maillet D" first="Denis" last="Maillet">Denis Maillet</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Service d'Oncologie Médicale, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon</s1><s2>Pierre-Bénite</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Pierre-Bénite</wicri:noRegion><wicri:noRegion>Hospices Civils de Lyon</wicri:noRegion><wicri:noRegion>Pierre-Bénite</wicri:noRegion></affiliation></author><author><name sortKey="You, Benoit" sort="You, Benoit" uniqKey="You B" first="Benoit" last="You">Benoit You</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Service d'Oncologie Médicale, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon</s1><s2>Pierre-Bénite</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Pierre-Bénite</wicri:noRegion><wicri:noRegion>Hospices Civils de Lyon</wicri:noRegion><wicri:noRegion>Pierre-Bénite</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Journal of the National Cancer Institute</title><title level="j" type="abbreviated">J. Natl. Cancer Inst.</title><idno type="ISSN">0027-8874</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Journal of the National Cancer Institute</title><title level="j" type="abbreviated">J. Natl. Cancer Inst.</title><idno type="ISSN">0027-8874</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Bibliographic review</term><term>Cancerology</term><term>Human</term><term>Malignant tumor</term><term>Published document</term><term>Quality</term><term>Randomized controlled trial</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Tumeur maligne</term><term>Qualité</term><term>Document publié</term><term>Cancérologie</term><term>Revue bibliographique</term><term>Traitement</term><term>Homme</term><term>Essai randomisé contrôlé</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background The Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in the mid-1990s for the explicit purpose of improving clinical trial reporting. However, there is little information regarding the adherence to CONSORT guidelines of recent publications of randomized controlled trials (RCTs) in oncology. Methods All phase III RCTs published between 2005 and 2009 were reviewed using an 18-point overall quality score for reporting based on the 2001 CONSORT statement. Multivariable linear regression was used to identify features associated with improved reporting quality. To provide baseline data for future evaluations of reporting quality, RCTs were also assessed according to the 2010 revised CONSORT statement. All statistical tests were two-sided. Results A total of 357 RCTs were reviewed.The mean 2001 overall quality score was 13.4 on a scale of 0-18, whereas the mean 2010 overall quality score was 19.3 on a scale of 0-27. The overall RCT reporting quality score improved by 0.21 points per year from 2005 to 2009. Poorly reported items included method used to generate the random allocation (adequately reported in 29% of trials), whether and how blinding was applied (41%), method of allocation concealment (51%), and participant flow (59%). High impact factor (IF, P = .003), recent publication date (P = .008), and geographic origin of RCTs (P = .003) were independent factors statistically significantly associated with higher reporting quality in a multivariable regression model. Sample size, tumor type, and positivity of trial results were not associated with higher reporting quality, whereas funding source and treatment type had a borderline statistically significant impact. Conclusion The results show that numerous items remained unreported for many trials.Thus, given the potential impact of poorly reported trials, oncology journals should require even stricter adherence to the CONSORT guidelines.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Canada</li><li>France</li></country><region><li>Ontario</li></region><settlement><li>Hamilton (Ontario)</li></settlement><orgName><li>Université McMaster</li></orgName></list><tree><country name="France"><noRegion><name sortKey="Peron, Julien" sort="Peron, Julien" uniqKey="Peron J" first="Julien" last="Peron">Julien Peron</name></noRegion><name sortKey="Almufti, Roula" sort="Almufti, Roula" uniqKey="Almufti R" first="Roula" last="Almufti">Roula Almufti</name><name sortKey="Maillet, Denis" sort="Maillet, Denis" uniqKey="Maillet D" first="Denis" last="Maillet">Denis Maillet</name><name sortKey="You, Benoit" sort="You, Benoit" uniqKey="You B" first="Benoit" last="You">Benoit You</name></country><country name="Canada"><region name="Ontario"><name sortKey="Pond, Gregory R" sort="Pond, Gregory R" uniqKey="Pond G" first="Gregory R." last="Pond">Gregory R. Pond</name></region><name sortKey="Chen, Eric X" sort="Chen, Eric X" uniqKey="Chen E" first="Eric X." last="Chen">Eric X. Chen</name></country><country name="Australie"><noRegion><name sortKey="Gan, Hui K" sort="Gan, Hui K" uniqKey="Gan H" first="Hui K." last="Gan">Hui K. Gan</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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