А. А. Новик, Т. И. Ионова, С. А. Калядина, Т. П. Никитина, К. А. Курбатова
New instrument for symptom assessment in patients with breast cancer–CSP-Br: development and pilot testing
Symptom assessment is an essential part of health control in patients with breast cancer before treatment as well, as during anticancer therapy. We aimed to develop and to test a new comprehensive instrument for symptoms assessment in patients with breast cancer. On the basis of international guidelines for PRO-instruments development, FDA guidelines, and a new questionnaire – CSP-Br has been developed for assessment of 57 symptoms in patients with breast cancer.
The structure of the CSP-Br was examined and the results of pilot testing in population of patients with breast cancer were observed. Acceptability of the CSP-Br for using in patients with breast cancer was shown and the content validity of this questionnaire was confirmed.
Preliminary results of psychometric characteristics assessment were revealed and high reliability and construct validity of the primary version of the CSP-Br were demonstrated as well as sensitivity to changes in time was shown. It’s necessary to re-test the psychometric characteristics of the CSP-Br in larger sample of patients with breast cancer before to recommend its’ using for symptom assessment in this patient population in clinical practice and research trials.