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

Ruben Mesa, Ralph V. Boccia, Michael R. Grunwald, Stephen T. Oh, Philomena Colucci, Dilan Paranagama, Shreekant Parasuraman, Brady L. Stein

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Data from REVEAL (Prospective Observational Study of Patients With Polycythemia Vera in US Clinical Practices; n = 2309), the first study of its kind, confirm that many patients experience quality of life and work productivity impairments that might negatively affect their lives. In the future, longitudinal data from REVEAL will be important for evaluating how such burdens change over time. Background: Patients with polycythemia vera (PV) often experience symptoms that adversely affect their quality of life (QoL). The ongoing, prospective, observational REVEAL (Prospective Observational Study of Patients With Polycythemia Vera in US Clinical Practices) study was designed to collect contemporary data regarding burden of disease, clinical management, patient-reported outcomes (PROs), and health care resource utilization from adult patients with PV in the United States. Patients and Methods: Data on PROs were collected at enrollment using the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS; range, 0-100); the European Organization for Research and Treatment of Cancer–Core Quality of Life Questionnaire, version 3.0 (EORTC QLQ-C30; range, 0-100); and the Work Productivity and Activity Impairment Questionnaire–Specific Health Problem (WPAI-SHP; range, 0%-100%). Results: Among 2309 patients, mean (SD) disease duration was 5.8 (6.1) years and Charlson Comorbidity Index was 3.4 (0.8); 54.0% (1247/2309) were male. Mean (SD) MPN-SAF TSS was 18.8 (15.5). The most common symptoms were fatigue (80.1% [1844/2302]), early satiety (60.9% [1402/2302]), and inactivity (57.6% [1324/2302]). The most common severe symptoms were fatigue (16.8% [387/2302]), itching (13.4% [308/2302]), and inactivity (11.8% [271/2302]). The mean (SD) EORTC QLQ-C30 global health status/QoL score was 73.1 (23.2): mean functional subscale scores ranged from 80.5 (23.9) for cognitive functioning to 85.7 (24.6) for social functioning. The mean WPAI-SHP activity impairment score was 19.7% (n = 2300). Employed patients had mean WPAI-SHP scores for absenteeism, presenteeism, and overall work impairment of 3.2% (n = 810), 12.1% (n = 807), and 13.4% (n = 802), respectively. Conclusion: These data confirm that many patients with PV experience symptoms, QoL impairments, and work productivity impairments that negatively affect their lives. Longitudinal data from REVEAL will be important for evaluating how PROs change over time in these patients.

Original languageEnglish (US)
Pages (from-to)590-596
Number of pages7
JournalClinical Lymphoma, Myeloma and Leukemia
Volume18
Issue number9
DOIs
StatePublished - Sep 1 2018

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Polycythemia Vera
Observational Studies
Prospective Studies
Quality of Life
Fatigue
Patient Acceptance of Health Care
Patient Reported Outcome Measures
Efficiency
Absenteeism
Symptom Assessment
Health Resources
Pruritus
Disease Management
Health Status
Comorbidity
Organizations

Keywords

  • Activity impairment
  • Myeloproliferative neoplasm
  • Quality of life
  • Symptoms
  • Work productivity

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

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. / Mesa, Ruben; Boccia, Ralph V.; Grunwald, Michael R.; Oh, Stephen T.; Colucci, Philomena; Paranagama, Dilan; Parasuraman, Shreekant; Stein, Brady L.

In: Clinical Lymphoma, Myeloma and Leukemia, Vol. 18, No. 9, 01.09.2018, p. 590-596.

Research output: Contribution to journalArticle

Mesa, Ruben ; Boccia, Ralph V. ; Grunwald, Michael R. ; Oh, Stephen T. ; Colucci, Philomena ; Paranagama, Dilan ; Parasuraman, Shreekant ; Stein, Brady L. / 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. In: Clinical Lymphoma, Myeloma and Leukemia. 2018 ; Vol. 18, No. 9. pp. 590-596.
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abstract = "Data from REVEAL (Prospective Observational Study of Patients With Polycythemia Vera in US Clinical Practices; n = 2309), the first study of its kind, confirm that many patients experience quality of life and work productivity impairments that might negatively affect their lives. In the future, longitudinal data from REVEAL will be important for evaluating how such burdens change over time. Background: Patients with polycythemia vera (PV) often experience symptoms that adversely affect their quality of life (QoL). The ongoing, prospective, observational REVEAL (Prospective Observational Study of Patients With Polycythemia Vera in US Clinical Practices) study was designed to collect contemporary data regarding burden of disease, clinical management, patient-reported outcomes (PROs), and health care resource utilization from adult patients with PV in the United States. Patients and Methods: Data on PROs were collected at enrollment using the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS; range, 0-100); the European Organization for Research and Treatment of Cancer–Core Quality of Life Questionnaire, version 3.0 (EORTC QLQ-C30; range, 0-100); and the Work Productivity and Activity Impairment Questionnaire–Specific Health Problem (WPAI-SHP; range, 0{\%}-100{\%}). Results: Among 2309 patients, mean (SD) disease duration was 5.8 (6.1) years and Charlson Comorbidity Index was 3.4 (0.8); 54.0{\%} (1247/2309) were male. Mean (SD) MPN-SAF TSS was 18.8 (15.5). The most common symptoms were fatigue (80.1{\%} [1844/2302]), early satiety (60.9{\%} [1402/2302]), and inactivity (57.6{\%} [1324/2302]). The most common severe symptoms were fatigue (16.8{\%} [387/2302]), itching (13.4{\%} [308/2302]), and inactivity (11.8{\%} [271/2302]). The mean (SD) EORTC QLQ-C30 global health status/QoL score was 73.1 (23.2): mean functional subscale scores ranged from 80.5 (23.9) for cognitive functioning to 85.7 (24.6) for social functioning. The mean WPAI-SHP activity impairment score was 19.7{\%} (n = 2300). Employed patients had mean WPAI-SHP scores for absenteeism, presenteeism, and overall work impairment of 3.2{\%} (n = 810), 12.1{\%} (n = 807), and 13.4{\%} (n = 802), respectively. Conclusion: These data confirm that many patients with PV experience symptoms, QoL impairments, and work productivity impairments that negatively affect their lives. Longitudinal data from REVEAL will be important for evaluating how PROs change over time in these patients.",
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T1 - Patient-Reported Outcomes Data From REVEAL at the Time of Enrollment (Baseline)

T2 - A Prospective Observational Study of Patients With Polycythemia Vera in the United States

AU - Mesa, Ruben

AU - Boccia, Ralph V.

AU - Grunwald, Michael R.

AU - Oh, Stephen T.

AU - Colucci, Philomena

AU - Paranagama, Dilan

AU - Parasuraman, Shreekant

AU - Stein, Brady L.

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N2 - Data from REVEAL (Prospective Observational Study of Patients With Polycythemia Vera in US Clinical Practices; n = 2309), the first study of its kind, confirm that many patients experience quality of life and work productivity impairments that might negatively affect their lives. In the future, longitudinal data from REVEAL will be important for evaluating how such burdens change over time. Background: Patients with polycythemia vera (PV) often experience symptoms that adversely affect their quality of life (QoL). The ongoing, prospective, observational REVEAL (Prospective Observational Study of Patients With Polycythemia Vera in US Clinical Practices) study was designed to collect contemporary data regarding burden of disease, clinical management, patient-reported outcomes (PROs), and health care resource utilization from adult patients with PV in the United States. Patients and Methods: Data on PROs were collected at enrollment using the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS; range, 0-100); the European Organization for Research and Treatment of Cancer–Core Quality of Life Questionnaire, version 3.0 (EORTC QLQ-C30; range, 0-100); and the Work Productivity and Activity Impairment Questionnaire–Specific Health Problem (WPAI-SHP; range, 0%-100%). Results: Among 2309 patients, mean (SD) disease duration was 5.8 (6.1) years and Charlson Comorbidity Index was 3.4 (0.8); 54.0% (1247/2309) were male. Mean (SD) MPN-SAF TSS was 18.8 (15.5). The most common symptoms were fatigue (80.1% [1844/2302]), early satiety (60.9% [1402/2302]), and inactivity (57.6% [1324/2302]). The most common severe symptoms were fatigue (16.8% [387/2302]), itching (13.4% [308/2302]), and inactivity (11.8% [271/2302]). The mean (SD) EORTC QLQ-C30 global health status/QoL score was 73.1 (23.2): mean functional subscale scores ranged from 80.5 (23.9) for cognitive functioning to 85.7 (24.6) for social functioning. The mean WPAI-SHP activity impairment score was 19.7% (n = 2300). Employed patients had mean WPAI-SHP scores for absenteeism, presenteeism, and overall work impairment of 3.2% (n = 810), 12.1% (n = 807), and 13.4% (n = 802), respectively. Conclusion: These data confirm that many patients with PV experience symptoms, QoL impairments, and work productivity impairments that negatively affect their lives. Longitudinal data from REVEAL will be important for evaluating how PROs change over time in these patients.

AB - Data from REVEAL (Prospective Observational Study of Patients With Polycythemia Vera in US Clinical Practices; n = 2309), the first study of its kind, confirm that many patients experience quality of life and work productivity impairments that might negatively affect their lives. In the future, longitudinal data from REVEAL will be important for evaluating how such burdens change over time. Background: Patients with polycythemia vera (PV) often experience symptoms that adversely affect their quality of life (QoL). The ongoing, prospective, observational REVEAL (Prospective Observational Study of Patients With Polycythemia Vera in US Clinical Practices) study was designed to collect contemporary data regarding burden of disease, clinical management, patient-reported outcomes (PROs), and health care resource utilization from adult patients with PV in the United States. Patients and Methods: Data on PROs were collected at enrollment using the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS; range, 0-100); the European Organization for Research and Treatment of Cancer–Core Quality of Life Questionnaire, version 3.0 (EORTC QLQ-C30; range, 0-100); and the Work Productivity and Activity Impairment Questionnaire–Specific Health Problem (WPAI-SHP; range, 0%-100%). Results: Among 2309 patients, mean (SD) disease duration was 5.8 (6.1) years and Charlson Comorbidity Index was 3.4 (0.8); 54.0% (1247/2309) were male. Mean (SD) MPN-SAF TSS was 18.8 (15.5). The most common symptoms were fatigue (80.1% [1844/2302]), early satiety (60.9% [1402/2302]), and inactivity (57.6% [1324/2302]). The most common severe symptoms were fatigue (16.8% [387/2302]), itching (13.4% [308/2302]), and inactivity (11.8% [271/2302]). The mean (SD) EORTC QLQ-C30 global health status/QoL score was 73.1 (23.2): mean functional subscale scores ranged from 80.5 (23.9) for cognitive functioning to 85.7 (24.6) for social functioning. The mean WPAI-SHP activity impairment score was 19.7% (n = 2300). Employed patients had mean WPAI-SHP scores for absenteeism, presenteeism, and overall work impairment of 3.2% (n = 810), 12.1% (n = 807), and 13.4% (n = 802), respectively. Conclusion: These data confirm that many patients with PV experience symptoms, QoL impairments, and work productivity impairments that negatively affect their lives. Longitudinal data from REVEAL will be important for evaluating how PROs change over time in these patients.

KW - Activity impairment

KW - Myeloproliferative neoplasm

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KW - Symptoms

KW - Work productivity

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