Interprétation automatisée du CPET : Étude de validation internationale
Étude Internationale de Validation de l'Interprétation Automatisée pour les Tests d'Effort Cardiopulmonaire
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Marieke Wuyts
- Numéro de téléphone: 016 34 31 59
- E-mail: marieke.wuyts@kuleuven.be
Lieux d'étude
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Aalst, Belgique, 9300
- Recrutement
- AZORG
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Contact:
- Dimitri Stylemans
- Numéro de téléphone: 0032 53 72 42 89
- E-mail: dimitri.stylemans@azorg.be
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Chercheur principal:
- Dimitri Stylemans
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Hasselt, Belgique
- Pas encore de recrutement
- Jessa Ziekenhuis
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Contact:
- Iwein Gyselinck
- Numéro de téléphone: 0032 11 33 55 77
- E-mail: Iwein.Gyselinck@jessazh.be
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Chercheur principal:
- Iwein Gyselinck
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Leuven, Belgique, 3000
- Recrutement
- UZ Leuven
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Chercheur principal:
- Wim Janssens
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Contact:
- Marieke Wuyts
- Numéro de téléphone: 016 34 31 59
- E-mail: marieke.wuyts@kuleuven.be
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Patients referred for a CPET in one of the participating centers
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in agreement between KOLs and algorithm-generated CPET interpretation report on the survey
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Baseline agreement between KOLs and algorithm-generated CPET interpretation report on the survey
Délai: 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
Délai: 6 months
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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
Délai: At baseline, at 6 months, and the change between baseline and 6 months
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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
Délai: 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
Délai: Baseline, 3 months and 6 months
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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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Wim Janssens, UZ/KU Leuven
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- S70961
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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