2025 · Journal of medical Internet research · open access
Digital Biomarkers of Cytokine Release Syndrome: Scoping Review and Ontology Development of the Role and Relevance of Digital Measures Using a Mixed Methods Approach
Medberry et al.
The finding, in our words
The scoping review developed an ontology of early warning signs for cytokine release syndrome, identifying temperature, heart rate, blood pressure and oxygen saturation as the core digital measures. Standardising these digital biomarkers will create fit-for-purpose datasets to support predictive models and decentralised trials in oncology.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
In 50 cancer patients monitored at home with an Apple Watch for 28 days, a method that classified missing step data by gap duration and context produced the most reliable daily step estimates. Daily step counts on days with at least ten hours of wear time predicted time to first clinical event (p=0.068) and identified participants at lower hazard of mortality, with 83.3% accuracy for clinical event prediction, demonstrating that processed consumer wearable data can support remote monitoring in decentralised oncology trials.
Oakley-Girvan et al., Digital biomarkers · source ↗
A direct-to-participant, multichannel recruitment strategy enrolled 34,244 older adults into a virtual trial testing an Apple Watch based heart health programme with electrocardiogram and irregular rhythm notification features, achieving broad geographic and gender diversity but under-representing non-White ethnic groups.
Analysis of six studies revealed that decentralised clinical trial elements enhanced data completeness by enabling direct access to medical records, although this introduced a significant burden for data abstraction. The results suggest that decentralised approaches are not a universal solution but provide specific metrics that can help design fit-for-purpose trials.
Wearable-derived digital biomarkers have been accepted by regulatory agencies as endpoints in clinical trials for Duchenne muscular dystrophy, showing their potential to support decentralised diagnostics through patient-centric monitoring. This matters because it enables more sensitive and continuous assessment of disease progression outside clinical settings.
Ma et al., Neurology and therapy (paywalled) · source ↗
The High-Definition Oncology feasibility study in 30 women with metastatic cancer demonstrated high adherence to biospecimen collection (97.4% plasma, 80.7% stool) and wearable monitoring (70–95% of days captured for activity, heart rate, sleep, and oxygen saturation). This establishes a viable framework for decentralised, multimodal data collection in oncology to support individualised treatment models.
Garma et al., JCO precision oncology (paywalled) · source ↗