Automated CPET Interpretation: International Validation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiopulmonary Exercise Test. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
International Validation Study of Automated Interpretation for Cardiopulmonary Exercise Testing
Overview
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.
Primary outcome measures
- Change in agreement between KOLs and algorithm-generated CPET interpretation report on the survey [Time frame: between baseline and 6 months]
Secondary outcome measures (5)
- Baseline agreement between KOLs and algorithm-generated CPET interpretation report on the survey [Time frame: Baseline]
- Agreement at 6 months between KOLs and the algorithm-generated CPET interpretation report on the survey [Time frame: 6 months]
- Changes in self-reported confidence scores before and after the automated report [Time frame: At baseline, at 6 months, and the change between baseline and 6 months]
- Feedback on the automated protocols during the 6-month implementation period [Time frame: During the 6 months implementation period]
- Descriptive evaluation of center-level CPET interpretation practices [Time frame: Baseline, 3 months and 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Belgium · 2 centers
- AZORG — Aalst
- UZ Leuven — Leuven
Identifiers
NCT: NCT07534384 · S70961