Prospective Validation of the Swedish Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF: Swedish) In 114 MPN Patients

Abstract

AbstractAbstract 5053 Background:The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) is a concise instrument of patient reported outcomes (PRO) designed to assess the unique spectrum of symptoms present in the majority of patients (Mesa et. al. Cancer 2007). We sought to validate the Swedish Translation of the MPN-SAF which addresses 19 separate symptoms reported by MPN patients. Methods:We utilized the standard practice of PRO translation in which 3 independent translations are created by 3 independent translators fluent in both languages. A fourth translator then discussed the translations with the other translators and a consensus translation was obtained. Patients self completed the MPN-SAF: Swedish at the time of a physician office visit and the Swedish EORTC-QLQ-C30 was co-administered for validation purposes. Results:Patients and Symptomatic Burden: 114 patients were prospectively enrolled (ET (N=53; 47%), PV (N=53; 47%) and MF (N=8; 6%)) a median of 6 years (range:0-42) from their diagnosis. Patients were of a median age (68; range 27–88 years) and gender (53% females) typical of the disease. 78% (N=88) had received some form of non-aspirin medical therapy for their disease, and 75% were on therapy at the time of completing the questionnaire. Patients frequently had a history of either thrombotic events (26%) and/or hemorrhagic events (10%). The MPN-SAF measured 19 items in the enrolled patients (data summarized in Table 1). Validation Analysis:EORTC-QLQ-C30 Consistent with our experience with the MPN-SAF:English Pearson correlations between MPN-SAF-Swedish individual symptom scores and the Swedish EORTC-QLQ C30 showed excellent correlations with co-validation questions including fatigue, pain, headache, insomnia, early satiety, and sad mood (all p<0.001). Correlations with EORTC-QLQ-C30 subscales demonstrated excellent correlations between MPN-SAF measurements and corresponding subscales. Comparison with Mpn-Saf:English:Comparison with 102 patients prospectively completing the MPN-SAF: English (ET=20, PV=N=23, MF=59) showed (when adjusting for MPN subtype) excellent correlation with all but 3 items in which the prevalence of the symptoms was similar but the severity less in the Swedish cohort (early satiety, headache and impaired quality of life). Additionally, the ranking of the prevalence of symptoms was very well correlated between both cohorts when controlling for disease type. Conclusions:The MPN-SAF: Swedish is an easy to administer, clear, 19 item inventory of patient reported outcomes that is specific to MPNs. Additionally, the instrument is validated by 1) comparison to previously validated Swedish Instruments and 2) the correlation with the MPN-SAF:English. Utilization of the instrument in Swedish MPN clinical trials will allow for useful comparison to patients completing the MPN-SAF in other countries.Table 1:Symptomatic burden of MPNs as assessed by the MPN-SAF in 114 Swedish patients (results are reported as mean (95% confidence interval of the mean). All Items measured on a 0 (Absent) to 10 (worst imaginable) scale.ET (N=53)PV (N=53)MF (N=8)TotalFatigue (BFI Score)2.72 (2.1–3.3)3.0 (2.4–3.6)3.6 (1.7–5.5)2.6 (2.5–3.3)Early Satiety1.5 (1.0–2.1)2.3 (1.5–3.1)1.8 (0.2–3.3)1.9 (1.4–2.3)Abdominal Pain0.8 (0.4–1.2)1.2 (0.6–1.9)1.0 (0.1–2.1)1.0 (0.7–1.4)Abdominal Discomfort1.2 (0.7–1.8)1.5 (0.8–2.2)1.8 (0.1–3.5)1.4 (1.0–1.8)Inactivity1.4 (0.9–1.8)1.8 (1.2–2.5)3.9 (1.7–6.0)1.8 (1.4–2.2)Headache1.3 (0.7–1.9)1.2 (0.7–1.6)1.1 (0.1–2.4)1.2 (0.9–1.6)Concentration Problem1.8 (1.1–2.4)1.9 (1.3–2.5)2.8 (0.1–5.4)1.9 (1.5–2.4)Dizziness1.8 (1.2–2.4)1.8 (1.1–2.5)1.5 (0.1–3.5)1.8 (2.2–4.0)Numbness2.1 (1.4–2.8)2.5 (1.7–3.4)2.8 (0.1–5.4)2.3 (1.8–2.9)Insomnia2.7 (2.0–3.4)3.0 (2.2–3.8)2.1 (0.5–3.7)2.8 (2.3–3.3)Sad Mood2.1 (1.4–2.7)2.0 (1.4–2.6)1.1 (0.1–2.5)2.0 (1.5–2.4)Sexuality Problems1.9 (1.1–2.8)2.5 (1.5–3.5)5.0 (1.6–8.4)2.4 (1.8–3.1)Cough1.5 (0.9–2.1)1.4 (0.9–2.0)1.6 (0.1–3.2)1.5 (1.1–1.9)Night Sweats2.0 (1.2–2.7)2.7 (1.8–3.5)1.4 (0.1–2.6)2.3 (1.7–2.8)Itching1.3 (0.7–2.0)1.9 (1.2–2.6)1.9 (0.1–4.7)1.6 (1.2–2.1)Bone Pain1.3 (0.8–1.9)1.7 (0.9–2.4)2.1 (0.1–4.5)1.5 (1.1–2.0)Fever0.3 (0.1–0.4)0.3 (0.1–0.4)0.6 (0.1–1.2)0.3 (0.2–0.4)Weight Loss0.4 (0.1–0.6)1.2 (0.6–1.8)1.4 (0.1–2.8)0.9 (0.5–1.2)Quality of Life2.3 (1.7–2.9)2.5 (2.0–3.1)2.9 (0.5–5.3)2.5 (2.0–2.9) Disclosures:Samuelsson:Roche Sweden:Mesa:SBio: Research Funding; Novartis: Research Funding; Celgene: Research Funding; Incyte: Research Funding; Roche: Research Funding; eisai: Research Funding; telik: Research Funding.