Interpretazione Automatizzata del CPET: Studio di Validazione Internazionale
Studio di Validazione Internazionale dell'Interpretazione Automatica per i Test da Sforzo Cardiopolmonare
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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Marieke Wuyts
- Numero di telefono: 016 34 31 59
- Email: marieke.wuyts@kuleuven.be
Luoghi di studio
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Aalst, Belgio, 9300
- Reclutamento
- AZORG
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Contatto:
- Dimitri Stylemans
- Numero di telefono: 0032 53 72 42 89
- Email: dimitri.stylemans@azorg.be
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Investigatore principale:
- Dimitri Stylemans
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Hasselt, Belgio
- Non ancora reclutamento
- Jessa Ziekenhuis
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Contatto:
- Iwein Gyselinck
- Numero di telefono: 0032 11 33 55 77
- Email: Iwein.Gyselinck@jessazh.be
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Investigatore principale:
- Iwein Gyselinck
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Leuven, Belgio, 3000
- Reclutamento
- UZ Leuven
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Investigatore principale:
- Wim Janssens
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Contatto:
- Marieke Wuyts
- Numero di telefono: 016 34 31 59
- Email: marieke.wuyts@kuleuven.be
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Patients referred for a CPET in one of the participating centers
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in agreement between KOLs and algorithm-generated CPET interpretation report on the survey
Lasso di tempo: between baseline and 6 months
|
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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Baseline agreement between KOLs and algorithm-generated CPET interpretation report on the survey
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
|
Feedback on the automated protocols during the 6-month implementation period
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Wim Janssens, UZ/KU Leuven
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- S70961
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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