Clinical Summary: 

• Design/Population: This qualitative observational study interviewed adults with polycythemia vera who required frequent phlebotomy to better characterize symptom burden, disease impact, and the relevance of commonly used patient-reported outcome instruments.
• Key Outcomes: Patients reported substantial symptom burden, particularly fatigue, pruritus, and low energy, along with significant effects on sleep, daily activities, and work. Findings also supported the content validity of the PROMIS Fatigue Short Form-8a and the Myelofibrosis Symptom Assessment Form in polycythemia vera. 
• Clinical Relevance: These findings provide a more comprehensive understanding of the patient experience in polycythemia vera and support the use of validated patient-reported outcome measures in clinical trials and routine care.

Results from a qualitative study demonstrated that patients with polycythemia vera experience substantial symptom burden and quality-of-life impairment, while supporting the use of 2 commonly employed patient-reported outcome instruments in this population.

“[Polycythemia vera] is a myeloproliferative neoplasm characterized by excessive red blood cell production… patients with [polycythemia vera] report a substantial symptom burden, including fatigue, pruritus, and concentration problems,” stated David Cella, PhD, Northwestern University, Chicago, Illinois, and coauthors. “To our knowledge, this is the first observational qualitative interview study focused on the [polycythemia vera] patient experience.”

In this observational study, 20 adult patients with documented polycythemia vera who required at least 3 phlebotomies annually participated in one-on-one semi-structured interviews. Investigators conducted concept elicitation interviews to identify symptoms and disease impacts and performed cognitive debriefing to evaluate patient understanding and relevance of the PROMIS Fatigue Short Form-8a and the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0.

Concept elicitation interviews identified 44 signs and symptoms and 33 disease-related impacts. Among these, 15 symptoms and 21 impacts were considered salient based on frequency and patient-reported burden. Common symptoms included fatigue, pruritus, and low energy, while major impacts included sleep disturbances, limitations in daily activities, and reduced work productivity. Findings were used to refine a conceptual disease model incorporating 16 symptoms and 21 impacts associated with polycythemia vera.

During cognitive debriefing, patients reported that the PROMIS Fatigue Short Form-8a was clear, easy to understand, and relevant to their experience, particularly in capturing fatigue, the most frequently reported symptom. The MFSAF was also considered clear, understandable, and largely representative of the polycythemia vera experience.

“The qualitative evidence from these combined CE/CD interviews in 20 patients has produced a more comprehensive understanding of [polycythemia vera], which has been represented in a conceptual model… and also supports the content validity of the PROMIS Fatigue SF-8a and the MFSAF in [polycythemia vera],” concluded Dr Cella et al. “These findings informed the patient-reported end points in the phase 3 VERIFY study.”

Source: 

Cella D, Pettit KM, Bankar A, et al. Symptoms and life impact of polycythemia vera (PV): Results from a qualitative patient interview study. Presented at the 2026 ASCO Annual Meeting. Chicago, Illinois. Abstract e23259.