Clinically relevant outcomes in dental clinical trials: challenges and proposals

Detalhes bibliográficos
Autor(a) principal: PANNUTI,Claudio Mendes
Data de Publicação: 2020
Outros Autores: SENDYK,Daniel Isaac, GRAÇAS,Yasmin Teixeira das, TAKAI,Sandra Lie, SABÓIA,Vicente de Paulo Aragão, ROMITO,Giuseppe Alexandre, MENDES,Fausto Medeiros
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Brazilian Oral Research
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1806-83242020000300601
Resumo: 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.
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spelling Clinically relevant outcomes in dental clinical trials: challenges and proposalsClinical TrialTreatment OutcomeBiomarkersAbstract 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.Sociedade Brasileira de Pesquisa Odontológica - SBPqO2020-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1806-83242020000300601Brazilian Oral Research v.34 suppl.2 2020reponame:Brazilian Oral Researchinstname:Sociedade Brasileira de Pesquisa Odontológica (SBPqO)instacron:SBPQO10.1590/1807-3107bor-2020.vol34.0073info:eu-repo/semantics/openAccessPANNUTI,Claudio MendesSENDYK,Daniel IsaacGRAÇAS,Yasmin Teixeira dasTAKAI,Sandra LieSABÓIA,Vicente de Paulo AragãoROMITO,Giuseppe AlexandreMENDES,Fausto Medeiroseng2020-08-05T00:00:00Zoai:scielo:S1806-83242020000300601Revistahttps://www.scielo.br/j/bor/https://old.scielo.br/oai/scielo-oai.phppob@edu.usp.br||bor@sbpqo.org.br1807-31071806-8324opendoar:2020-08-05T00:00Brazilian Oral Research - Sociedade Brasileira de Pesquisa Odontológica (SBPqO)false
dc.title.none.fl_str_mv Clinically relevant outcomes in dental clinical trials: challenges and proposals
title Clinically relevant outcomes in dental clinical trials: challenges and proposals
spellingShingle Clinically relevant outcomes in dental clinical trials: challenges and proposals
PANNUTI,Claudio Mendes
Clinical Trial
Treatment Outcome
Biomarkers
title_short Clinically relevant outcomes in dental clinical trials: challenges and proposals
title_full Clinically relevant outcomes in dental clinical trials: challenges and proposals
title_fullStr Clinically relevant outcomes in dental clinical trials: challenges and proposals
title_full_unstemmed Clinically relevant outcomes in dental clinical trials: challenges and proposals
title_sort Clinically relevant outcomes in dental clinical trials: challenges and proposals
author PANNUTI,Claudio Mendes
author_facet PANNUTI,Claudio Mendes
SENDYK,Daniel Isaac
GRAÇAS,Yasmin Teixeira das
TAKAI,Sandra Lie
SABÓIA,Vicente de Paulo Aragão
ROMITO,Giuseppe Alexandre
MENDES,Fausto Medeiros
author_role author
author2 SENDYK,Daniel Isaac
GRAÇAS,Yasmin Teixeira das
TAKAI,Sandra Lie
SABÓIA,Vicente de Paulo Aragão
ROMITO,Giuseppe Alexandre
MENDES,Fausto Medeiros
author2_role author
author
author
author
author
author
dc.contributor.author.fl_str_mv PANNUTI,Claudio Mendes
SENDYK,Daniel Isaac
GRAÇAS,Yasmin Teixeira das
TAKAI,Sandra Lie
SABÓIA,Vicente de Paulo Aragão
ROMITO,Giuseppe Alexandre
MENDES,Fausto Medeiros
dc.subject.por.fl_str_mv Clinical Trial
Treatment Outcome
Biomarkers
topic Clinical Trial
Treatment Outcome
Biomarkers
description 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.
publishDate 2020
dc.date.none.fl_str_mv 2020-01-01
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
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status_str publishedVersion
dc.identifier.uri.fl_str_mv http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1806-83242020000300601
url http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1806-83242020000300601
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.1590/1807-3107bor-2020.vol34.0073
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv text/html
dc.publisher.none.fl_str_mv Sociedade Brasileira de Pesquisa Odontológica - SBPqO
publisher.none.fl_str_mv Sociedade Brasileira de Pesquisa Odontológica - SBPqO
dc.source.none.fl_str_mv Brazilian Oral Research v.34 suppl.2 2020
reponame:Brazilian Oral Research
instname:Sociedade Brasileira de Pesquisa Odontológica (SBPqO)
instacron:SBPQO
instname_str Sociedade Brasileira de Pesquisa Odontológica (SBPqO)
instacron_str SBPQO
institution SBPQO
reponame_str Brazilian Oral Research
collection Brazilian Oral Research
repository.name.fl_str_mv Brazilian Oral Research - Sociedade Brasileira de Pesquisa Odontológica (SBPqO)
repository.mail.fl_str_mv pob@edu.usp.br||bor@sbpqo.org.br
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