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PROs From the REVEAL Study Show Impact of PV on Patients' Lives

Kelly Davio
The ongoing REVEAL study, a prospective observational study of US patients with the myeloproliferative neoplasm polycythemia vera (PV), is designed to gather data on disease burden, clinical management, patient-reported outcomes (PROs), and healthcare resource utilization of this patient population.
The ongoing REVEAL study, a prospective observational study of US patients with the myeloproliferative neoplasm polycythemia vera (PV), is designed to gather data on disease burden, clinical management, patient-reported outcomes (PROs), and healthcare resource utilization of this patient population. A report newly published in Clinical Lymphoma, Myeloma & Leukemia described data on PROs collected at enrollment, and confirmed that many patients with PV experience symptoms and impairments that negatively affect their lives. 

 
Patients’ symptom burden was assessed using the Myeloproliferative Neoplasm Symptom Assessment Form total symptom score assessment, which grades 10 items (fatigue, early satiety, abdominal discomfort, inactivity, problems with concentration, night sweats, itching, bone pain, fever, and unintentional weight loss) on a scale of 0 to 10, with 10 representing the highest burden. The total score was a sum of the individual items’ scores. 
Of the 2307 patients who reported MPN-SAF scores at enrollment, 93% reported at least 1 symptom, with the most frequently reported symptoms comprising fatigue (80.1%), early satiety (60.9%), and inactivity (57.6%). The symptom with the highest reported mean severity score was fatigue, with a score of 3.5 (standard deviation [SD], 2.7).


Measuring symptoms by the European Organization for Research and Treatment of Cancer–Core Quality of Life Questionnaire, on a scale of 0 to 100, with higher scores representing higher symptom burden, fatigue (29.9; SD, 27.8) also presented the highest burden. Pain (20.0; SD, 28.2) and dyspnea (17.2; SD, 27.5) also had severe symptom burden scores. 

Patients also had work productivity and activity impairments at enrollment. Measured by the Work Productivity and Activity Impairment Questionnaire–Specific Health Problem scale, in which higher percentages represented greater impairment, the mean activity score was 19.7%. Among employed patients, scores for absenteeism, presenteeism, and overall impairment to work were 3.2%, 12.1%, and 13.4%, respectively.

The symptom burden associated with PV has a negative impact on quality of life, daily activities, and work productivity for many patients, write the authors, and while it is important to control blood counts to decrease the risk of thrombotic events, it is also important for clinicians to evaluate patients for symptom burden. Furtherdata from the REVEAL study, write the authors, will facilitate better understanding of how patients’ symptom burden changes over time.

Reference

Mesa R, Boccia RV, Grunwald MR, et al. Patient-reported outcomes data from REVEAL at the time of enrollment (baseline): a prospective observational study of patients with polycythemia vera in the United States. Clin Lymphoma Myeloma Leuk. 2018;18(9):590-596. doi: 10.1016/j.clml.2018.05.020.

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