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| Name | Class |
|---|---|
| AZORG | UNKNOWN |
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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:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in agreement between KOLs and algorithm-generated CPET interpretation report on the survey | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline agreement between KOLs and algorithm-generated CPET interpretation report on the survey | 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. |
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Patients referred for a cardiopulmonary exercise test (CPET):
Inclusion Criteria:
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.
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Patients referred for a CPET in one of the participating centers
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marieke Wuyts | Contact | 016 34 31 59 | marieke.wuyts@kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Wim Janssens | UZ/KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZORG | Aalst | 9300 | Belgium |
|
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| Baseline |
| Agreement at 6 months between KOLs and the algorithm-generated CPET interpretation report on the survey | 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 | 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 | 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 |
| Descriptive evaluation of center-level CPET interpretation practices | 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 |
| UZ Leuven | Leuven | 3000 | Belgium |
|