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Clinical Requirements

Clinical Objectives

  • Detect HF worsening earlier through multi‑modal ambient QoL trends.
  • Track changes post‑therapy optimization (e.g., GDMT up‑titration) and events (ED visit, hospitalization).
  • Provide clinician‑interpretable domains tied to actionable plans.

Clinical Content

  • Domains: Physical, Emotional/Cognitive, Social/Behavioral, Symptom Burden, Environmental.
  • Reference Instruments: KCCQ‑12 (adjunct); optional PHQ‑2/GAD‑2; PROMIS Physical Function (short form).
  • Signals: Steps, HR/HRV, sleep, routine regularity, speech features (tempo, pitch var., pauses), geospatial breadth, noise/light, weather/air quality indices.

Validation Plan

  • Design: Prospective cohort (n≈60–120) across NYHA II–IV.
  • Endpoints: Correlation with KCCQ‑12 subscales; responsiveness to clinical change; predictive value for decompensation within 7–14 days.
  • Stats: Target r ≥ 0.5 with KCCQ overall; AUC ≥ 0.75 for decompensation prediction.
  • Safety: Clinical review of all Urgent alerts within 24h; DSMB‑like oversight for pilots.

Clinician Workflow

  1. Review domain trend cards (7/30/90d).
  2. Inspect recent alerts; acknowledge and choose plan (televisit, med adjustment, labs).
  3. Document action → writes FHIR CarePlan/ServiceRequest or note export.