Clinically relevant outcomes in dental clinical trials: challenges and proposals

Pannuti, Cláudio Sérgio; Sendyk, Daniel Isaac; Graças, Yasmin Teixeira das; Takai, Sandra Lie; Sabóia, Vicente de Paulo Aragão; Romito, Giuseppe Alexandre; Mendes, Fausto Medeiros

doi:10.1590/1807-3107bor-2020.vol34.0073

Cited by 25 publications

(26 citation statements)

References 47 publications

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“…Besides the aspects discussed in other manuscripts of this special issue, such as research transparency in all phases the study, aspects related to the study design, the methodological characteristics involved, and the problems related to the trial report, the choice of the outcomes is a fundamental step that is directly related to the relevance of the RCT, mainly when the goal is the implementation of evidence within clinical and health practices 1,3,5 …”

Section: Discussionmentioning

confidence: 99%

“…On the other hand, subjective outcomes (soft measures or soft outcomes) are more susceptible to examiners’ interpretation. Similarly, variables reported by the trial participants themselves are also subjective, since the variability between them is inherent 5,6,12 …”

Section: Why Researchers Should Preferentially Select Objective Outcomentioning

confidence: 99%

“…However, for accurate application of their findings to health care, trials must be well‐designed, conducted, and reported. Furthermore, they should assess relevant issues for daily clinics and patients 5 …”

Section: Introductionmentioning

confidence: 99%

“…The effects of the evaluated interventions of the clinical studies are compared in terms of outcome variables. These variables, also known as response variables, dependent variables, or endpoints, are assessed during the clinical study to compare the impact of the tested interventions on trial's participants 5,6 …”

Section: Introductionmentioning

confidence: 99%

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

Mendes

Braga

Pássaro

et al. 2020

Int J Paed Dentistry

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Why Researchers Should Preferentially Select Objective Outcomentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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

Mendes

Braga

Pássaro

et al. 2020

Int J Paed Dentistry

Self Cite

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show abstract

“…Replication is desirable in science, but too many replications are a waste of time and resources. Research questions must address outcomes that matter to the patients, but surrogate outcomes are still abundant in dental clinical trials 8,9 . Multicentre, pragmatic and broad simple trials are still uncommon in dentistry.…”

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confidence: 99%