T. I. Ionova, T. P. Nikitina, K. A. Kurbatova, A.Y. Rodionova

Characteristics of psychometric properties of the CSP-Myelofibrosis Module Questionnaire for Symptom Assessment in Patients with Myelofibrosis

The aim of the study was to assessment the psychometric properties of the questionnaire CSP-Myelofibrosis Module (CSP-MF) and the possibilities of its application for assessment of symptoms in patients with myelofibrosis (MF). In total 93 patients with MF who participated in the multicenter observational study «Quality of life and symptom profile in myelofibrosis: validation of the symptom assessment tool for patients with myelofibrosis» (2014–2015) were enrolled in the analysis; male/female – 37/56; median age – 59 years (interquartile range: 50–66.5, diapason 28–90 years); 62 patients on the best available treatment and 31 patients on ruxolitinib.

All the patients filled out the CSP-MF, SF-36, Treatment satisfaction questionnaire for medication and Patient Global Impression of Change (PGIC) tools. Questionnaire CSP-MF is designed for comprehensive assessment of 16 symptoms in patients with MF in the past week. We aimed to test practicability, validity, reliability and sensitivity of CSP-MF in MF patients.

Based on assessments hematologists, the opinions of experts in the field of Quality of Life Research and analysis of the literature found that the questionnaire consistent with international standards and is a complete tool for the assessment of symptoms in patients with MF. In order to assess the construct validity of CSP-MF the factor analysis was used as well as the method of "known-groups" and correlation analysis. It is shown that the questionnaire CSP-MF has satisfactory construct validity.

Chronbach alpha coefficient was calculated for reliability assessment. The values of the coefficient ?-Kronbaha>=0.8, that characterizes satisfactory reliability of the instrument. When assessing the sensitivity of the questionnaire CSP-MF studied the severity of symptoms in patients with different response to treatment related to the size of the spleen; was demonstrated Sensitivity of the tool to clinical changes.

The CSP-MF is an appropriate, practical, valid, reliable and sensitive tool to assess symptom profile and severity in MF patients. Comprehensive symptom monitoring using patient-reported outcome measures may be recommended to clearly determine treatment outcomes in this patient cohort.