Interpretação Automatizada de CPET: Estudo de Validação Internacional
Estudo Internacional de Validação da Interpretação Automatizada para Teste de Exercício Cardiopulmonar
The goal of this observational experimental study is to validate a rule-based algorithm to automate CPET interpretation.
The endpoints of this study are the following:
- The change in agreement between key opinion leaders (KOLs) and the algorithm-generated CPET interpretation reports, comparing baseline to the end of the 6 month study period.
- Baseline agreement between KOLs and the algorithm
- Agreement at 6 months between KOLs and the algorithm
- Change in self-reported confidence scores before and after using the automated report
- Feedback on automated protocols generated via the platform during the 6-month implementation period
- Descriptive evaluation of center-level CPET interpretation reports practices at three timepoints
Patients referred for a CPET will be included to collect observational data without interference within clinical routine. KOLs will be recruited from participating centres to fill out a survey for CPET interpretations.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Marieke Wuyts
- Número de telefone: 016 34 31 59
- E-mail: marieke.wuyts@kuleuven.be
Locais de estudo
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Aalst, Bélgica, 9300
- Recrutamento
- AZORG
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Contato:
- Dimitri Stylemans
- Número de telefone: 0032 53 72 42 89
- E-mail: dimitri.stylemans@azorg.be
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Investigador principal:
- Dimitri Stylemans
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Hasselt, Bélgica
- Ainda não está recrutando
- Jessa Ziekenhuis
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Contato:
- Iwein Gyselinck
- Número de telefone: 0032 11 33 55 77
- E-mail: Iwein.Gyselinck@jessazh.be
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Investigador principal:
- Iwein Gyselinck
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Leuven, Bélgica, 3000
- Recrutamento
- UZ Leuven
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Investigador principal:
- Wim Janssens
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Contato:
- Marieke Wuyts
- Número de telefone: 016 34 31 59
- E-mail: marieke.wuyts@kuleuven.be
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Patients referred for a CPET in one of the participating centers
Descrição
Patients referred for a cardiopulmonary exercise test (CPET):
Inclusion Criteria:
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form
- Patients referred for a CPET during their standard clinical care
Exclusion Criteria:
- If the participant has a disorder making it unable to perform a CPET, they must not proceed to be enrolled in the study and will be documented as a screen failure via applicable log forms in the Investigator Site File.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in agreement between KOLs and algorithm-generated CPET interpretation report on the survey
Prazo: between baseline and 6 months
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Change in agreement between key KOLs and the algorithm-generated CPET interpretation reports on the survey, comparing baseline (prior to implementation) to the 6-month study period. Agreement will be assessed per interpretation domain using percent agreement and Cohen's kappa, with comparisons made both at the individual KOL level and across all KOLs. |
between baseline and 6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Baseline agreement between KOLs and algorithm-generated CPET interpretation report on the survey
Prazo: Baseline
|
Baseline agreement on the survey between the KOLs and the CPET interpretation algorithm will be assessed. The survey assesses CPET interpretation both without and with access to the automated report. Agreement will be assessed per interpretation domain using percent agreement and Cohen's kappa, with comparisons made both at the individual KOL level and across all KOLs. This establishes the initial level of alignment before implementation and allows evaluation of the immediate effect of having access to the report. |
Baseline
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Agreement at 6 months between KOLs and the algorithm-generated CPET interpretation report on the survey
Prazo: 6 months
|
Agreement at 6 months on the survey between the KOLs and the CPET interpretation algorithm will be assessed. Again the survey assesses CPET interpretation both without and with access to the automated report. Agreement will be assessed per interpretation domain using percent agreement and Cohen's kappa, with comparisons made both at the individual KOL level and across all KOLs. |
6 months
|
|
Changes in self-reported confidence scores before and after the automated report
Prazo: At baseline, at 6 months, and the change between baseline and 6 months
|
Change in self-reported confidence scores before and after using the automated report. Confidence will be rated on a 5-point Likert scale across interpretation domains. Within-timepoint comparisons (without vs. with algorithm) and across-time comparisons (baseline vs. 6 months) will be made. |
At baseline, at 6 months, and the change between baseline and 6 months
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Feedback on the automated protocols during the 6-month implementation period
Prazo: During the 6 months implementation period
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Feedback on automated protocols generated via the platform during the 6-month implementation period. Changes will be categorised as: accept, accept with minor change, accept with major change or reject. This helps to quantify how the automated interpretation is accepted or refined in practice. |
During the 6 months implementation period
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Descriptive evaluation of center-level CPET interpretation practices
Prazo: Baseline, 3 months and 6 months
|
Descriptive evaluation of center-level CPET interpretation reports practices at three timepoints: at baseline, 3 months and 6 months on a random sample (n=10) of included participants of CPET interpretation reports per center, using structured qualitative coding of report content across interpretation domains to assess potential shifts in reporting style, terminology, and completeness. |
Baseline, 3 months and 6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Wim Janssens, UZ/KU Leuven
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- S70961
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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