One Size Does Not Fit All

Detalhes bibliográficos
Autor(a) principal: Hall, Deborah A.
Data de Publicação: 2019
Outros Autores: Hibbert, Alice, Smith, Harriet, Haider, Haúla F., Londero, Alain, Mazurek, Birgit, Fackrell, Kathryn
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10362/113977
Resumo: Good practice in clinical trials advocates common standards for assessing and reporting condition-specific complaints (“outcome domains”). For tinnitus, there is no common standard. The Core Outcome Measures in Tinnitus International Delphi (COMiT’ID) study created recommendations that are relevant to the most common intervention approaches for chronic subjective tinnitus in adults using consensus methods. Here, the objectives were to examine why it is important to tailor outcome domain selection to the tinnitus intervention that is being evaluated in the clinical trial and to demonstrate that the COMiT’ID recommendations are robust. The COMiT’ID study used an online three-round Delphi method with three separate surveys for sound-, psychology-, and pharmacology-based interventions. Survey data were analyzed to assess quality and confidence in the consensus achieved across surveys and stakeholder groups and between survey rounds. Results found participants were highly discriminatory in their decision-making. Of the 34 outcome domains reaching the prespecified consensus definition in the final round, 17 (50%) were unique to one intervention, while only 12 (35%) were common to all three. Robustness was demonstrated by an acceptable level of agreement across and within stakeholder groups, across survey rounds, across medical specialties (for the health-care practitioners), and across health-care users with varying tinnitus duration. There were few dissenting voices, and results showed no attrition bias. In conclusion, there is compelling evidence that one set of outcomes does not fit all therapeutic aims. Our analyses evidence robust decisions by the electronic Delphi process, leading to recommendations for three unique intervention-specific outcome domain sets. This provides an important starting point for standardization.
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spelling One Size Does Not Fit AllDeveloping Common Standards for Outcomes in Early-Phase Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adultsassessmentpatient-reported outcome measuresstakeholder agreementtreatment effectivenessOtorhinolaryngologySpeech and HearingGood practice in clinical trials advocates common standards for assessing and reporting condition-specific complaints (“outcome domains”). For tinnitus, there is no common standard. The Core Outcome Measures in Tinnitus International Delphi (COMiT’ID) study created recommendations that are relevant to the most common intervention approaches for chronic subjective tinnitus in adults using consensus methods. Here, the objectives were to examine why it is important to tailor outcome domain selection to the tinnitus intervention that is being evaluated in the clinical trial and to demonstrate that the COMiT’ID recommendations are robust. The COMiT’ID study used an online three-round Delphi method with three separate surveys for sound-, psychology-, and pharmacology-based interventions. Survey data were analyzed to assess quality and confidence in the consensus achieved across surveys and stakeholder groups and between survey rounds. Results found participants were highly discriminatory in their decision-making. Of the 34 outcome domains reaching the prespecified consensus definition in the final round, 17 (50%) were unique to one intervention, while only 12 (35%) were common to all three. Robustness was demonstrated by an acceptable level of agreement across and within stakeholder groups, across survey rounds, across medical specialties (for the health-care practitioners), and across health-care users with varying tinnitus duration. There were few dissenting voices, and results showed no attrition bias. In conclusion, there is compelling evidence that one set of outcomes does not fit all therapeutic aims. Our analyses evidence robust decisions by the electronic Delphi process, leading to recommendations for three unique intervention-specific outcome domain sets. This provides an important starting point for standardization.NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)RUNHall, Deborah A.Hibbert, AliceSmith, HarrietHaider, Haúla F.Londero, AlainMazurek, BirgitFackrell, Kathryn2021-03-16T23:20:35Z2019-01-292019-01-29T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10362/113977eng2331-2165PURE: 11540224https://doi.org/10.1177/2331216518824827info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-03-11T04:56:44Zoai:run.unl.pt:10362/113977Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:42:24.874880Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv One Size Does Not Fit All
Developing Common Standards for Outcomes in Early-Phase Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults
title One Size Does Not Fit All
spellingShingle One Size Does Not Fit All
Hall, Deborah A.
assessment
patient-reported outcome measures
stakeholder agreement
treatment effectiveness
Otorhinolaryngology
Speech and Hearing
title_short One Size Does Not Fit All
title_full One Size Does Not Fit All
title_fullStr One Size Does Not Fit All
title_full_unstemmed One Size Does Not Fit All
title_sort One Size Does Not Fit All
author Hall, Deborah A.
author_facet Hall, Deborah A.
Hibbert, Alice
Smith, Harriet
Haider, Haúla F.
Londero, Alain
Mazurek, Birgit
Fackrell, Kathryn
author_role author
author2 Hibbert, Alice
Smith, Harriet
Haider, Haúla F.
Londero, Alain
Mazurek, Birgit
Fackrell, Kathryn
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
RUN
dc.contributor.author.fl_str_mv Hall, Deborah A.
Hibbert, Alice
Smith, Harriet
Haider, Haúla F.
Londero, Alain
Mazurek, Birgit
Fackrell, Kathryn
dc.subject.por.fl_str_mv assessment
patient-reported outcome measures
stakeholder agreement
treatment effectiveness
Otorhinolaryngology
Speech and Hearing
topic assessment
patient-reported outcome measures
stakeholder agreement
treatment effectiveness
Otorhinolaryngology
Speech and Hearing
description Good practice in clinical trials advocates common standards for assessing and reporting condition-specific complaints (“outcome domains”). For tinnitus, there is no common standard. The Core Outcome Measures in Tinnitus International Delphi (COMiT’ID) study created recommendations that are relevant to the most common intervention approaches for chronic subjective tinnitus in adults using consensus methods. Here, the objectives were to examine why it is important to tailor outcome domain selection to the tinnitus intervention that is being evaluated in the clinical trial and to demonstrate that the COMiT’ID recommendations are robust. The COMiT’ID study used an online three-round Delphi method with three separate surveys for sound-, psychology-, and pharmacology-based interventions. Survey data were analyzed to assess quality and confidence in the consensus achieved across surveys and stakeholder groups and between survey rounds. Results found participants were highly discriminatory in their decision-making. Of the 34 outcome domains reaching the prespecified consensus definition in the final round, 17 (50%) were unique to one intervention, while only 12 (35%) were common to all three. Robustness was demonstrated by an acceptable level of agreement across and within stakeholder groups, across survey rounds, across medical specialties (for the health-care practitioners), and across health-care users with varying tinnitus duration. There were few dissenting voices, and results showed no attrition bias. In conclusion, there is compelling evidence that one set of outcomes does not fit all therapeutic aims. Our analyses evidence robust decisions by the electronic Delphi process, leading to recommendations for three unique intervention-specific outcome domain sets. This provides an important starting point for standardization.
publishDate 2019
dc.date.none.fl_str_mv 2019-01-29
2019-01-29T00:00:00Z
2021-03-16T23:20:35Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
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dc.identifier.uri.fl_str_mv http://hdl.handle.net/10362/113977
url http://hdl.handle.net/10362/113977
dc.language.iso.fl_str_mv eng
language eng
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PURE: 11540224
https://doi.org/10.1177/2331216518824827
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eu_rights_str_mv openAccess
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dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
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