Randomized clinical trials in periodontology: focus on outcomes selection

Detalhes bibliográficos
Autor(a) principal: PANNUTI,Claudio Mendes
Data de Publicação: 2021
Outros Autores: COSTA,Fernando Oliveira, SOUZA,Nathalia Vilela, RETAMAL-VALDES,Belen, COSTA,Amanda Almeida, SUSIN,Cristiano, FERES,Magda
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Brazilian Oral Research
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1806-83242021000300605
Resumo: Abstract Randomized clinical trials (RCTs) are human studies carried out to compare different treatments or interventions, and their results are used to support clinical decision-making and improve patient care. Herein, the aim of this study was to review the selection process of study outcomes in periodontology. Primary outcomes should draw the main conclusions of the study, whereas secondary outcomes should only be used to help explain the main findings and generate future research hypothesis. Outcomes are classified as clinically relevant (CROs) or surrogate outcomes. CROs – the first option for primary outcome variables - should convey not only substantial health benefits, but also be deemed important by patients. In periodontology, tooth loss/retention and oral health–related quality of life (OHRQoL) are examples of CROs. While tooth loss has main limitations as a primary outcome, emerging evidence suggest that patient-reported outcome measures (PROMs) can accurately detect OHRQoL following periodontal therapy. When CROs cannot be assessed, validated surrogate outcomes can be used as proxies. Primary outcome variables should reflect a treatment endpoint at the patient level that can be easily used to inform decision-making in daily practice. These outcomes should allow the implementation of a treat-to-target concept in which the intervention can be clearly judged against a prespecified treatment target. Recently, the presence of at most 4 sites with periodontal probing depth ≥5 mm post-treatment was suggested as an effective endpoint for periodontal trials. In perspective, a combination of validated clinical parameters and PROMs will provide a more comprehensive assessment of periodontal treatments.
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spelling Randomized clinical trials in periodontology: focus on outcomes selectionClinical TrialTreatment OutcomeAbstract Randomized clinical trials (RCTs) are human studies carried out to compare different treatments or interventions, and their results are used to support clinical decision-making and improve patient care. Herein, the aim of this study was to review the selection process of study outcomes in periodontology. Primary outcomes should draw the main conclusions of the study, whereas secondary outcomes should only be used to help explain the main findings and generate future research hypothesis. Outcomes are classified as clinically relevant (CROs) or surrogate outcomes. CROs – the first option for primary outcome variables - should convey not only substantial health benefits, but also be deemed important by patients. In periodontology, tooth loss/retention and oral health–related quality of life (OHRQoL) are examples of CROs. While tooth loss has main limitations as a primary outcome, emerging evidence suggest that patient-reported outcome measures (PROMs) can accurately detect OHRQoL following periodontal therapy. When CROs cannot be assessed, validated surrogate outcomes can be used as proxies. Primary outcome variables should reflect a treatment endpoint at the patient level that can be easily used to inform decision-making in daily practice. These outcomes should allow the implementation of a treat-to-target concept in which the intervention can be clearly judged against a prespecified treatment target. Recently, the presence of at most 4 sites with periodontal probing depth ≥5 mm post-treatment was suggested as an effective endpoint for periodontal trials. In perspective, a combination of validated clinical parameters and PROMs will provide a more comprehensive assessment of periodontal treatments.Sociedade Brasileira de Pesquisa Odontológica - SBPqO2021-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1806-83242021000300605Brazilian Oral Research v.35 suppl.2 2021reponame:Brazilian Oral Researchinstname:Sociedade Brasileira de Pesquisa Odontológica (SBPqO)instacron:SBPQO10.1590/1807-3107bor-2021.vol35.0100info:eu-repo/semantics/openAccessPANNUTI,Claudio MendesCOSTA,Fernando OliveiraSOUZA,Nathalia VilelaRETAMAL-VALDES,BelenCOSTA,Amanda AlmeidaSUSIN,CristianoFERES,Magdaeng2021-09-22T00:00:00Zoai:scielo:S1806-83242021000300605Revistahttps://www.scielo.br/j/bor/https://old.scielo.br/oai/scielo-oai.phppob@edu.usp.br||bor@sbpqo.org.br1807-31071806-8324opendoar:2021-09-22T00:00Brazilian Oral Research - Sociedade Brasileira de Pesquisa Odontológica (SBPqO)false
dc.title.none.fl_str_mv Randomized clinical trials in periodontology: focus on outcomes selection
title Randomized clinical trials in periodontology: focus on outcomes selection
spellingShingle Randomized clinical trials in periodontology: focus on outcomes selection
PANNUTI,Claudio Mendes
Clinical Trial
Treatment Outcome
title_short Randomized clinical trials in periodontology: focus on outcomes selection
title_full Randomized clinical trials in periodontology: focus on outcomes selection
title_fullStr Randomized clinical trials in periodontology: focus on outcomes selection
title_full_unstemmed Randomized clinical trials in periodontology: focus on outcomes selection
title_sort Randomized clinical trials in periodontology: focus on outcomes selection
author PANNUTI,Claudio Mendes
author_facet PANNUTI,Claudio Mendes
COSTA,Fernando Oliveira
SOUZA,Nathalia Vilela
RETAMAL-VALDES,Belen
COSTA,Amanda Almeida
SUSIN,Cristiano
FERES,Magda
author_role author
author2 COSTA,Fernando Oliveira
SOUZA,Nathalia Vilela
RETAMAL-VALDES,Belen
COSTA,Amanda Almeida
SUSIN,Cristiano
FERES,Magda
author2_role author
author
author
author
author
author
dc.contributor.author.fl_str_mv PANNUTI,Claudio Mendes
COSTA,Fernando Oliveira
SOUZA,Nathalia Vilela
RETAMAL-VALDES,Belen
COSTA,Amanda Almeida
SUSIN,Cristiano
FERES,Magda
dc.subject.por.fl_str_mv Clinical Trial
Treatment Outcome
topic Clinical Trial
Treatment Outcome
description Abstract Randomized clinical trials (RCTs) are human studies carried out to compare different treatments or interventions, and their results are used to support clinical decision-making and improve patient care. Herein, the aim of this study was to review the selection process of study outcomes in periodontology. Primary outcomes should draw the main conclusions of the study, whereas secondary outcomes should only be used to help explain the main findings and generate future research hypothesis. Outcomes are classified as clinically relevant (CROs) or surrogate outcomes. CROs – the first option for primary outcome variables - should convey not only substantial health benefits, but also be deemed important by patients. In periodontology, tooth loss/retention and oral health–related quality of life (OHRQoL) are examples of CROs. While tooth loss has main limitations as a primary outcome, emerging evidence suggest that patient-reported outcome measures (PROMs) can accurately detect OHRQoL following periodontal therapy. When CROs cannot be assessed, validated surrogate outcomes can be used as proxies. Primary outcome variables should reflect a treatment endpoint at the patient level that can be easily used to inform decision-making in daily practice. These outcomes should allow the implementation of a treat-to-target concept in which the intervention can be clearly judged against a prespecified treatment target. Recently, the presence of at most 4 sites with periodontal probing depth ≥5 mm post-treatment was suggested as an effective endpoint for periodontal trials. In perspective, a combination of validated clinical parameters and PROMs will provide a more comprehensive assessment of periodontal treatments.
publishDate 2021
dc.date.none.fl_str_mv 2021-01-01
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=S1806-83242021000300605
url http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1806-83242021000300605
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.1590/1807-3107bor-2021.vol35.0100
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
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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.35 suppl.2 2021
reponame:Brazilian Oral Research
instname:Sociedade Brasileira de Pesquisa Odontológica (SBPqO)
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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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