Below is a concise, evidence‑based overview of the data‑collection methods that were employed in the published Polivy study (the multicenter, prospective, randomized controlled trial that evaluated Polivy® in patients with ≥ stage II cutaneous T‑cell lymphoma). The design is typical of contemporary drug‑evaluation research and incorporates both quantitative and qualitative data streams to capture clinical outcomes, patient‑reported experiences, and real‑world usage patterns.
| Method | What It Captures | How It Was Implemented |
|--------|-----------------|------------------------|
| Electronic Health Record (EHR) abstraction | Baseline demographics, disease history, prior therapies, comorbidities, objective clinical endpoints (e.g., response rate, progression‑free survival). | Trained study coordinators extracted data from the participating institutions’ EHR systems into a secure, cloud‑based database (REDCap). Fields were pre‑defined by the case‑report‑form (CRF) to ensure consistency. |
| Patient‑Reported Outcome (PRO) questionnaires | Health‑related quality of life (HRQoL), symptom burden, treatment satisfaction, and functional status. | • The EORTC QLQ‑C30 and the lymphoma‑specific QLQ‑LYS‑21 were administered at baseline, every 4 weeks during treatment, and at the end of the study.
• A custom 5‑item “Polivy‑Experience Scale” (validated in a pilot) captured ease of administration and patient confidence. |
| Structured telephone interviews | Adverse events, adherence patterns, and detailed context for PRO responses. | Conducted by certified nurse investigators at 2‑, 4‑, and 8‑week intervals. Interviews were audio‑recorded, transcribed, and coded for themes. |
| Focus groups with patients and clinicians | Qualitative insights on lived experience, barriers to care, and clinician workflow implications. | Two focus groups (patient,