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Revisiting the OGIPRO Trial: Dynamic Electronic Patient-Reported Outcomes Compared with EQ-5D-5L in HER2-Positive
Anatol Aicher1, Marcus Vetter2,3, David Blum1,4
1Medical Faculty, University of Zurich, 8006 Zurich, Switzerland.
Dynamic electronic patient-reported outcomes (ePROs) for well-being closely align with the EQ-5D-5L visual analogue scale, validating their use in oncology. However, ePRO symptom data showed weaker agreement with EQ-5D-5L domains, requiring further research.
Area of Science:
- Oncology
- Digital Health
- Health Economics
Background:
- Patient-reported outcomes (PROs) are crucial for assessing cancer treatment tolerability and quality of life.
- Dynamic electronic PROs (ePROs) offer high-frequency longitudinal data, but their alignment with established measures like EQ-5D-5L is unclear.
- This study investigates the concordance between ePRO data and EQ-5D-5L in HER2-positive breast cancer patients.
Purpose of the Study:
- To evaluate the alignment between dynamic ePRO well-being scores and the EQ-5D-5L visual analogue scale (VAS).
- To assess the agreement between aggregated ePRO symptom grades and EQ-5D-5L domain scores and disutility.
- To determine the utility of ePROs as a substitute for EQ-5D-5L in clinical and research settings.
Main Methods:
- Retrospective analysis of data from the prospective OGIPRO trial (KEK-ZH 2021-D0051).
- Utilized linear mixed-effects modeling to analyze 13,699 dynamic ePRO data points from 53 patients with HER2-positive breast cancer.
- Compared ePRO well-being with EQ-5D-5L VAS, and ePRO symptom grades with EQ-5D-5L domain sums and disutility.
Main Results:
- Dynamic ePRO well-being demonstrated strong agreement with EQ-5D-5L VAS (β = 1.061), indicating low between-patient variability.
- Agreement between aggregated ePRO symptom grades and EQ-5D-5L domains/disutility was weaker and more heterogeneous across patients (β = 0.404 and β = 0.213, respectively).
Conclusions:
- Dynamic ePRO well-being is a valid substitute for EQ-5D-5L VAS in oncology research and clinical practice.
- Aggregated ePRO symptom data show limited concordance with EQ-5D-5L domains, suggesting a need for more granular analysis and larger datasets.
- Dynamic ePRO systems offer a scalable foundation for patient monitoring and AI-driven decision support in precision oncology.
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