자동화된 CPET 해석: 국제적 검증 연구
심폐 운동 검사 자동 판독의 국제적 타당성 연구
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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Marieke Wuyts
- 전화번호: 016 34 31 59
- 이메일: marieke.wuyts@kuleuven.be
연구 장소
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Aalst, 벨기에, 9300
- 모병
- AZORG
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연락하다:
- Dimitri Stylemans
- 전화번호: 0032 53 72 42 89
- 이메일: dimitri.stylemans@azorg.be
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수석 연구원:
- Dimitri Stylemans
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Hasselt, 벨기에
- 아직 모집하지 않음
- Jessa Ziekenhuis
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연락하다:
- Iwein Gyselinck
- 전화번호: 0032 11 33 55 77
- 이메일: Iwein.Gyselinck@jessazh.be
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수석 연구원:
- Iwein Gyselinck
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Leuven, 벨기에, 3000
- 모병
- UZ Leuven
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수석 연구원:
- Wim Janssens
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연락하다:
- Marieke Wuyts
- 전화번호: 016 34 31 59
- 이메일: marieke.wuyts@kuleuven.be
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients referred for a CPET in one of the participating centers
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in agreement between KOLs and algorithm-generated CPET interpretation report on the survey
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Baseline agreement between KOLs and algorithm-generated CPET interpretation report on the survey
기간: Baseline
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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
기간: 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
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Changes in self-reported confidence scores before and after the automated report
기간: At baseline, at 6 months, and the change between baseline and 6 months
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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
기간: During the 6 months implementation period
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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
기간: Baseline, 3 months and 6 months
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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
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .