Clinically relevant outcomes in dental clinical trials: challenges and proposals
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , , , , |
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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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 |
format |
article |
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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1750318327235870720 |