Automated CPET Interpretation: International Validation Study

N/ANot Yet RecruitingNCT07534384

KU Leuven600 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Cardiopulmonary Exercise Test

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: between baseline and 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

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

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.

Time frame: 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.

Time frame: Baseline, 3 months and 6 months