title: The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF): international prospective validation and reliability trial in 402 patients.
abstract: Symptomatic burden in myeloproliferative neoplasms is present in most patients and compromises quality of life. We sought to validate a broadly applicable 18-item instrument (Myeloproliferative Neoplasm Symptom Assessment Form [MPN-SAF], coadministered with the Brief Fatigue Inventory) to assess symptoms of myelofibrosis, essential thrombocythemia, and polycythemia vera among prospective cohorts in the United States, Sweden, and Italy. A total of 402 MPN-SAF surveys were administered (English [25%], Italian [46%], and Swedish [28%]) in 161 patients with essential thrombocythemia, 145 patients with polycythemia vera, and 96 patients with myelofibrosis. Responses among the 3 administered languages showed great consistency after controlling for MPN subtype. Strong correlations existed between individual items and key symptomatic elements represented on both the MPN-SAF and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30. Enrolling physicians' blinded opinion of patient symptoms (6 symptoms assessed) were highly correlated with corresponding patients' responses. Serial administration of the English MPN-SAF among 53 patients showed that most MPN-SAF items are well correlated (r > 0.5, P < .001) and highly reproducible (intraclass correlation coefficient > 0.7). The MPN-SAF is a comprehensive and reliable instrument that is available in multiple languages to evaluate symptoms associated with all types of MPNs in clinical trials globally.
authors.affiliation: Rosalind Franklin School of Medicine, Chicago, IL, USA.
authors.forename: Robyn
authors.initials: R
authors.lastname: Scherber
authors.forename: Amylou C
authors.initials: AC
authors.lastname: Dueck
authors.forename: Peter
authors.initials: P
authors.lastname: Johansson
authors.forename: Tiziano
authors.initials: T
authors.lastname: Barbui
authors.forename: Giovanni
authors.initials: G
authors.lastname: Barosi
authors.forename: Alessandro M
authors.initials: AM
authors.lastname: Vannucchi
authors.forename: Francesco
authors.initials: F
authors.lastname: Passamonti
authors.forename: Bjorn
authors.initials: B
authors.lastname: Andreasson
authors.forename: Maria L
authors.initials: ML
authors.lastname: Ferarri
authors.forename: Alessandro
authors.initials: A
authors.lastname: Rambaldi
authors.forename: Jan
authors.initials: J
authors.lastname: Samuelsson
authors.forename: Gunnar
authors.initials: G
authors.lastname: Birgegard
authors.forename: Ayalew
authors.initials: A
authors.lastname: Tefferi
authors.forename: Claire N
authors.initials: CN
authors.lastname: Harrison
authors.forename: Deepti
authors.initials: D
authors.lastname: Radia
authors.forename: Ruben A
authors.initials: RA
authors.lastname: Mesa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019046:Bone Marrow Neoplasms / Q000175:diagnosis* / Q000453:epidemiology; D015331:Cohort Studies; D005260:Female; D006306:Health Surveys; D006801:Humans; D038622:Internationality; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009196:Myeloproliferative Disorders / Q000175:diagnosis* / Q000453:epidemiology; D011788:Quality of Life; D011996:Records; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D013548:Sweden / Q000453:epidemiology; D014481:United States / Q000453:epidemiology