International Validation Study of Automated Interpretation for Cardiopulmonary Exercise Testing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- KU Leuven
- 入组人数
- 600
- 试验地点
- 5
- 主要终点
- Change in agreement between KOLs and algorithm-generated CPET interpretation report on the survey
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •- 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.
结局指标
主要结局
Change in agreement between KOLs and algorithm-generated CPET interpretation report on the survey
时间窗: between baseline and 6 months
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.
次要结局
- Baseline agreement between KOLs and algorithm-generated CPET interpretation report on the survey(Baseline)
- Agreement at 6 months between KOLs and the algorithm-generated CPET interpretation report on the survey(6 months)
- Changes in self-reported confidence scores before and after the automated report(At baseline, at 6 months, and the change between baseline and 6 months)
- Feedback on the automated protocols during the 6-month implementation period(During the 6 months implementation period)
- Descriptive evaluation of center-level CPET interpretation practices(Baseline, 3 months and 6 months)