Nonpublication and Selective Outcome Reporting of Oral Health Trials
DIAKONOFF, Hadrien
Institut Droit et Santé [IDS - U1145]
UFR Odontologie [Santé] - Université Paris Cité [UFR Odontologie UPCité]
Institut Droit et Santé [IDS - U1145]
UFR Odontologie [Santé] - Université Paris Cité [UFR Odontologie UPCité]
KHALIL, G.
Chimie de la matière complexe [CMC]
Evaluation thérapeutique et pharmacologie périnatale et pédiatrique [EA_7323]
Chimie de la matière complexe [CMC]
Evaluation thérapeutique et pharmacologie périnatale et pédiatrique [EA_7323]
JUNGO, Sébastien
UFR Odontologie [Santé] - Université Paris Cité [UFR Odontologie UPCité]
Service d'Odontologie [Bretonneau]
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UFR Odontologie [Santé] - Université Paris Cité [UFR Odontologie UPCité]
Service d'Odontologie [Bretonneau]
DIAKONOFF, Hadrien
Institut Droit et Santé [IDS - U1145]
UFR Odontologie [Santé] - Université Paris Cité [UFR Odontologie UPCité]
Institut Droit et Santé [IDS - U1145]
UFR Odontologie [Santé] - Université Paris Cité [UFR Odontologie UPCité]
KHALIL, G.
Chimie de la matière complexe [CMC]
Evaluation thérapeutique et pharmacologie périnatale et pédiatrique [EA_7323]
Chimie de la matière complexe [CMC]
Evaluation thérapeutique et pharmacologie périnatale et pédiatrique [EA_7323]
JUNGO, Sébastien
UFR Odontologie [Santé] - Université Paris Cité [UFR Odontologie UPCité]
Service d'Odontologie [Bretonneau]
UFR Odontologie [Santé] - Université Paris Cité [UFR Odontologie UPCité]
Service d'Odontologie [Bretonneau]
TRELUYER, Jean-Marc
Institut Necker Enfants-Malades [INEM - UM 111 (UMR 8253 / U1151)]
Evaluation thérapeutique et pharmacologie périnatale et pédiatrique [EA_7323]
Institut Necker Enfants-Malades [INEM - UM 111 (UMR 8253 / U1151)]
Evaluation thérapeutique et pharmacologie périnatale et pédiatrique [EA_7323]
FRON CHABOUIS, Hélène
Institut de Chimie de la Matière Condensée de Bordeaux [ICMCB]
Faculté d'odontologie
Groupe hospitalier Saint-André
Institut de Chimie de la Matière Condensée de Bordeaux [ICMCB]
Faculté d'odontologie
Groupe hospitalier Saint-André
SMAÏL-FAUGERON, Violaine
UFR Odontologie [Santé] - Université Paris Cité [UFR Odontologie UPCité]
Evaluation thérapeutique et pharmacologie périnatale et pédiatrique [EA_7323]
Service d'Odontologie [Bretonneau]
< Réduire
UFR Odontologie [Santé] - Université Paris Cité [UFR Odontologie UPCité]
Evaluation thérapeutique et pharmacologie périnatale et pédiatrique [EA_7323]
Service d'Odontologie [Bretonneau]
Langue
en
Article de revue
Ce document a été publié dans
Journal of Dental Research. 2023, vol. 102, n° 6, p. 599-607
SAGE Publications (UK and US)
Résumé en anglais
Less 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 ...Lire la suite >
Less 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.< Réduire
Mots clés en anglais
Clinical protocols
Randomized controlled trial
Publication bias
Humans
Registries
Bias
Origine
Importé de halUnités de recherche