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Nonpublication and Selective Outcome Reporting of Oral Health Trials

hal.structure.identifierInstitut Droit et Santé [IDS - U1145]
hal.structure.identifierUFR Odontologie [Santé] - Université Paris Cité [UFR Odontologie UPCité]
dc.contributor.authorDIAKONOFF, Hadrien
hal.structure.identifierChimie de la matière complexe [CMC]
hal.structure.identifierEvaluation thérapeutique et pharmacologie périnatale et pédiatrique [EA_7323]
dc.contributor.authorKHALIL, G.
hal.structure.identifierUFR Odontologie [Santé] - Université Paris Cité [UFR Odontologie UPCité]
hal.structure.identifierService d'Odontologie [Bretonneau]
dc.contributor.authorJUNGO, Sébastien
hal.structure.identifierInstitut Necker Enfants-Malades [INEM - UM 111 (UMR 8253 / U1151)]
hal.structure.identifierEvaluation thérapeutique et pharmacologie périnatale et pédiatrique [EA_7323]
dc.contributor.authorTRELUYER, Jean-Marc
hal.structure.identifierInstitut de Chimie de la Matière Condensée de Bordeaux [ICMCB]
hal.structure.identifierFaculté d'odontologie
hal.structure.identifierGroupe hospitalier Saint-André
dc.contributor.authorFRON CHABOUIS, Hélène
hal.structure.identifierUFR Odontologie [Santé] - Université Paris Cité [UFR Odontologie UPCité]
hal.structure.identifierEvaluation thérapeutique et pharmacologie périnatale et pédiatrique [EA_7323]
hal.structure.identifierService d'Odontologie [Bretonneau]
dc.contributor.authorSMAÏL-FAUGERON, Violaine
dc.date.issued2023
dc.identifier.issn0022-0345
dc.description.abstractEnLess than one-quarter of oral health trials are registered in a public registry. However, no study has assessed the extent of study publication and selective outcome reporting bias in the field of oral health. We identified oral health trials registered between 2006 and 2016 in ClinicalTrials.gov. We assessed whether results of early discontinued trials, trials having an unknown status, and completed trials had been published and, among published trials, whether outcomes differed between the registered record and the corresponding publication. We included 1,399 trials, of which 81 (5.8%) were discontinued, 247 (17.7%) had an unknown status, and 1,071 (76.6%) were completed. The registration was prospective for 719 (51.9%) trials. Over half the registered trials were unpublished ( n = 793, 56.7%). To explore the association between trials publication and characteristics of trials, we performed a multivariate logistic regression analysis. Trials conducted in the United States ( P = 0.003) or Brazil ( P < 0.001) were associated with increased odds of publication, whereas trials registered prospectively ( P = 0.001) and industry-sponsored trials ( P = 0.02) were associated with decreased odds. Among the 479 published trials with completed status, the primary outcomes of 215 (44.9%) articles differed from that registered. Major discrepancies consisted of the introduction of a new primary outcome in the published article (196 [91.2%]) and the transformation of a registered secondary outcome into a primary outcome (112 [52.1%]). In the remaining 264 (55.1%) trials, primary outcomes did not differ from that registered, but 141 (53.4%) had been registered retrospectively. Our study highlights the high rate of nonpublication and selective outcome reporting in the field of oral health. These results could alert sponsors, funders, authors of systematic reviews, and the oral health research community at large to combat the nondisclosure of trial results.
dc.language.isoen
dc.publisherSAGE Publications (UK and US)
dc.subject.enClinical protocols
dc.subject.enRandomized controlled trial
dc.subject.enPublication bias
dc.subject.enHumans
dc.subject.enRegistries
dc.subject.enBias
dc.title.enNonpublication and Selective Outcome Reporting of Oral Health Trials
dc.typeArticle de revue
dc.identifier.doi10.1177/00220345231158544
dc.subject.halSciences du Vivant [q-bio]/Médecine humaine et pathologie
dc.subject.halSciences de l'Homme et Société/Sciences de l'information et de la communication
bordeaux.journalJournal of Dental Research
bordeaux.page599-607
bordeaux.volume102
bordeaux.issue6
bordeaux.peerReviewedoui
hal.identifierhal-04136668
hal.version1
hal.popularnon
hal.audienceInternationale
hal.origin.linkhttps://hal.archives-ouvertes.fr//hal-04136668v1
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