A Scoping Literature Review of Digital Measures and Patient-Reported Outcomes for Refractory/Unexplained Chronic Cough: Assessment of Clinical Trials and Real-World Clinical Practice
Skinner et al.
The finding, in our words
The scoping review of 70 studies found that clinical trials for chronic cough predominantly use digital cough frequency as the primary endpoint, while real-world observational studies employ a broader variety of digital measures and patient-reported outcomes, indicating evolving approaches to decentralised assessment.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
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 ↗
Merck describes a digitally enabled, patient-centric trial initiative that combines outpatient PK/PD sampling with digital biomarkers and smart dosing technologies to improve exposure-response understanding and reduce patient burden, while acknowledging adoption challenges.
Dockendorf et al., Clinical and translational science · 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.
A 2025 review from China finds decentralised trials still far from standard practice despite the enthusiasm of regulators and industry, and names the operational gaps that keep them so: technology, oversight and data quality.