Table 1 Boao Lecheng innovative medical devices’ real-world data
Category | Data Sources | Collection Method | Information Collected |
|---|---|---|---|
Medical data outside of Boao Lecheng | Patients’ local medical institutions | Proactive collection | Past medical history, past diagnoses and treatments, compliances, other follow-up data, etc. |
Medical data within Boao Lecheng | Medical institutions in Boao Lecheng | Routine collection | Symptoms, diagnoses, imaging, lab results, prescriptions, other medical information, etc. |
Proactive collection | Adverse events, patient-reported outcomes, etc. | ||
Data from past research of medical devices | Medical device manufacturers | Proactive collection | Overseas registration information, published data, etc. |
Data collected from other devices or innovative platforms | Wearable devices | Routine collection | Heart rate, blood pressure, sleeping status, daily activities, etc. |
Boao Lecheng Real-World Data Research Platform | Routine collection | Product tracing and monitoring across entire life cycle of a medical device | |
“Lecheng Health” smartphone app | Routine collection | Patient recruitment, patient registration, appointments, on-line consultation, product compliance, self-reported adverse events, etc. |