Clinically relevant outcomes in dental clinical trials: challenges and proposals
Braz. oral res. (Online)
;
34(supl.2): e073, 2020. tab
Artículo
en Inglés
| LILACS, BBO
| ID: biblio-1132731
ABSTRACT
Abstract The impact of clinical trials on patient care depends on the outcomes that they evaluate. In Dentistry, many trials use outcomes that are important to clinicians, but not to the patients. Thus, the aim of the present manuscript is to present an overview of the limitations, challenges, and proposals on the use of clinically relevant outcomes (CRO) in dental trials. Clinically relevant outcomes are variables that directly measure how the patient feels, functions, or survives. Some CROs, such as tooth loss, implant failure, and restorations failure require many years to occur and the number of events is low. The adoption of these variables as primary outcomes results in challenges for the researchers, such as use of large sample sizes and long follow-up periods. Surrogate outcomes, such as biomarkers, radiographic measurements and indexes, are frequently used to replace CROs. However, they present many limitations, since the effect of the treatment on a surrogate does not necessarily reflect a change in the clinical outcome. Some proposals for the adoption of CROs are presented, such as the development of core outcome sets within each dental specialties and the organization of multi-center clinical trials.
Texto completo:
Disponible
Índice:
LILACS (Américas)
Asunto principal:
Ensayos Clínicos como Asunto
Límite:
Humanos
Idioma:
Inglés
Revista:
Braz. oral res. (Online)
Asunto de la revista:
Odontología
Año:
2020
Tipo del documento:
Artículo
País de afiliación:
Brasil
Institución/País de afiliación:
Universidade Federal do Ceará/BR
/
Universidade de São Paulo/BR
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