Automatisierte CPET-Interpretation: Internationale Validierungsstudie
Internationale Validierungsstudie zur automatisierten Interpretation der kardiopulmonalen Belastungsuntersuchung
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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Marieke Wuyts
- Telefonnummer: 016 34 31 59
- E-Mail: marieke.wuyts@kuleuven.be
Studienorte
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Aalst, Belgien, 9300
- Rekrutierung
- AZORG
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Kontakt:
- Dimitri Stylemans
- Telefonnummer: 0032 53 72 42 89
- E-Mail: dimitri.stylemans@azorg.be
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Hauptermittler:
- Dimitri Stylemans
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Hasselt, Belgien
- Noch keine Rekrutierung
- Jessa Ziekenhuis
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Kontakt:
- Iwein Gyselinck
- Telefonnummer: 0032 11 33 55 77
- E-Mail: Iwein.Gyselinck@jessazh.be
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Hauptermittler:
- Iwein Gyselinck
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Leuven, Belgien, 3000
- Rekrutierung
- UZ Leuven
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Hauptermittler:
- Wim Janssens
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Kontakt:
- Marieke Wuyts
- Telefonnummer: 016 34 31 59
- E-Mail: marieke.wuyts@kuleuven.be
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Patients referred for a CPET in one of the participating centers
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in agreement between KOLs and algorithm-generated CPET interpretation report on the survey
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Baseline agreement between KOLs and algorithm-generated CPET interpretation report on the survey
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: During the 6 months implementation period
|
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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Wim Janssens, UZ/KU Leuven
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- S70961
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
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