Selective outcome reporting in paediatric dentistry restorative treatment randomised clinical trials—A meta-research

Elagami, Rokaia Ahmed, Tedesco, Tamara Kerber, Pannuti, Claudio Mendes, Da Silva, Gabriela Seabra, Braga, Mariana Minatel, Mendes, Fausto Medeiros and Raggio, Daniela Procida ORCID: https://orcid.org/0000-0002-0048-2068 2023. Selective outcome reporting in paediatric dentistry restorative treatment randomised clinical trials—A meta-research. International Journal of Paediatric Dentistry 33 (1) , pp. 89-98. 10.1111/ipd.13024

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Abstract

Background Selective outcome reporting (SOR) is a bias that occurs when the primary outcome of a randomised clinical trial (RCT) is omitted or changed. Aim We evaluated the prevalence of SOR in RCTs on restorative treatment in primary teeth. Design We conducted an electronic search on ClinicalTrials.gov and the World Health Organisation platform (International Clinical Trials Registry Platform) on 1st April/2021 with no time or language restrictions. We included RCT protocols that evaluated restorative treatments in primary teeth and excluded trials that did not have a complete publication in a scientific journal. The Chi-square test was used to identify the association between SOR and variables as a discrepancy in the follow-up period, timing of registration, type of sponsorship, and study design (α=5%). Results Of the 294 identified protocols, 30 were included in the study. 83.3% of trials were registered retrospectively. SOR was observed in 53.3% (n=16) of the published trials and was significantly associated with a discrepancy in the follow-up period (p=0.017). Conclusion The high prevalence of SOR in restorative treatment RCTs proves that this is a prominent threat. A proper pre-registered protocol, declaration of any protocol deviation, and allowing stakeholders to compare the protocol with the submitted papers will achieve transparency.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Dentistry
Publisher:	Wiley
ISSN:	0960-7439
Date of First Compliant Deposit:	21 July 2022
Date of Acceptance:	30 June 2022
Last Modified:	11 Oct 2023 21:36
URI:	https://orca.cardiff.ac.uk/id/eprint/151409

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