How researchers should select the best outcomes for randomised clinical trials in paediatric dentistry?

Mendes, Fausto M., Braga, Mariana M., Pássaro, Ana Laura, Moro, Bruna L. P., Freitas, Raiza Dias, Gimenez, Thais, Tedesco, Tamara K., Raggio, Daniela P. ORCID: https://orcid.org/0000-0002-0048-2068 and Pannuti, Claudio M. 2020. How researchers should select the best outcomes for randomised clinical trials in paediatric dentistry? International Journal of Paediatric Dentistry 31 (S1) , pp. 23-30. 10.1111/ipd.12743

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Abstract

Randomised clinical trial (RCT) is the best study design to evaluate the effect of the treatment and preventive healthcare procedures. The effects of the tested treatments on patient's health are compared in terms of outcomes, which are used to evaluate the participants' health changes. However, these outcomes should be relevant for the target population. In that way, RCTs represent the type of primary study design that provides the most reliable evidence to implement therapies into the clinical practice. In this review, an outline of some aspects related to the choice of RCTs' outcomes was presented, focusing on the conduction of relevant trials in Paediatric Dentistry. The importance and necessity of defining a primary outcome were addressed, preferentially a clinically relevant endpoint. The patients should perceive this outcome, and changes in this variable should reflect directly patient's health improvement or impairment. Moreover, considerations about the objective or subjective variables, use of surrogate outcomes, and the increasing tendency to develop core outcome sets were also presented in this review. The main idea of this manuscript is the RCTs must evaluate outcomes relevant to the children's oral health in order to contribute to the implementation of treatments in the evidence-based health practice.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Dentistry
Publisher:	British Society of Paediatric Dentistry (BSPD)
ISSN:	0960-7439
Date of Acceptance:	18 October 2020
Last Modified:	10 Nov 2022 10:59
URI:	https://orca.cardiff.ac.uk/id/eprint/148868

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