A.A. Novik, T.I. Ionova, S. A. Kalyadina, T. P. Nikitina, D. A. Fedorenko, N. E. Mochkin, K. A. Kurbatova
New instrument for symptom assessment in lymphoma patients: development and pilot testing
Symptom assessment is an essential part of health control in patients with lymphomas 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 lymphomas.
On the basis of international guidelines for PRO-instruments development, FDA guidelines, a new questionnaire - CSP-Lym has been developed for assessment of 41 symptoms in patients with lymphomas. The structure of the CSP-Lym was examined and the results of pilot testing in population of patients with lymphomas before treatment were observed. Acceptability of the CSP-Lym for using in patients with lymphomas 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-Lym were demonstrated. It's necessary to re-test the psychometric characteristics of the CSP-Lym 41 in larger sample of lymphoma patients before to recommend its' using for symptom assessment in patients with lymphomas in clinical practice and research trials.