Development and Validation Results of the Russian MPN10 Form for Symptom Assessment in Patients with Myeloproliferative Neoplasms Compliant with International Recommendations

AUTOIMMUNE THROMBOCYTOPENIA

TI Ionova1,2, OYu Vinogradova3,4,5, EV Efremova6, AE Kersilova6, TP Nikitina1,2, MM Pankrashkina3, NM Porfir’eva2, A-PA Poshivai6, MS Fominykh6,7, DI Shikhbabaeva3, VA Shuvaev6

1 NI Pirogov Clinic for High Medical Technology, Saint Petersburg State University, 7-9 Universitetskaya nab., Saint Petersburg, Russian Federation, 199034

2 Multinational Research Center for Quality of Life, 1 Artilleriiskaya str., Saint Petersburg, Russian Federation, 191014

3 SP Botkin Municipal Clinical Hospital, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284

4 Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology, 1 Samory Mashela str., Moscow, Russian Federation, 117997

5 NI Pirogov Russian National Research Medical University, 1 Ostrovityanova str., Moscow, Russian Federation, 117997

6 Russian Research Institute of Hematology and Transfusiology, 16 2-ya Sovetskaya str., Saint Petersburg, Russian Federation, 191024

7 Saint Petersburg State University, 7-9 Universitetskaya nab., Saint Petersburg, Russian Federation, 199034

For correspondence: Tat’yana Pavlovna Nikitina, MD, PhD, 1 Artilleriiskaya str., Saint Petersburg, Russian Federation, 191014; Tel.: +7(962)710-17-12; e-mail: qolife@mail.ru

For citation: Ionova TI, Vinogradova OYu, Efremova EV, et al. Development and Validation Results of the Russian MPN10 Form for Symptom Assessment in Patients with Myeloproliferative Neoplasms Compliant with International Recommendations. Clinical oncohematology. 2020;13(2):176–84 (In Russ).

DOI: 10.21320/2500-2139-2020-13-2-176-184

ABSTRACT

Aim. To develop a Russian version of MPN10 form for patients with myeloproliferative neoplasms (MPN) compliant with international recommendations.

Materials & Methods. The trial included 57 patients treated in 2019 at the Moscow Municipal Center for Hematology of the SP Botkin Clinical Hospital (n = 30) and the Russian Research Institute of Hematology and Transfusiology (n = 27). Among them there were 36 myelofibrosis, 9 polycythemia vera, and 12 essential thrombocythemia patients. Mean age of the patients was 54.6 years (standard deviation 15.9 years; age range 20–79 years). The male/female ratio was 23/34 (40.4 %/59.6 %). Underlying disease duration was from 1 month to 33 years (mean duration 7 years; standard deviation 8.6 years).

Results. A stable structure and a high inner consistency of the form as well as its reproducibility as a tool were demonstrated. The trial also confirmed its convergent and discriminant validity and satisfactory sensitivity to changes in a patient’s status.

Conclusion. The Russian MPN10 version can be used for symptom assessment in MPN patients in clinical practice and scientific research.

Keywords: symptom assessment form, myeloproliferative neoplasms, psychometric properties of the form, validation.

Received: January 15, 2020

Accepted: March 29, 2020

Read in PDF

REFERENCES

  1. Меликян А.Л., Ковригина А.М., Суборцева И.Н. и др. Национальные клинические рекомендации по диагностике и терапии Ph-негативных миелопролиферативных заболеваний (истинная полицитемия, эссенциальная тромбоцитемия, первичный миелофиброз) (редакция 2018 г.). Гематология и трансфузиология. 2018;63(3):275–315. doi: 10.25837/HAT.2019.51.88.001.

    [Melikyan AL, Kovrigina AM, Subortseva IN, et al. National сlinical recommendations for diagnosis and therapy of Ph-negative myeloproliferative neoplasms (polycythemia vera, essential thrombocythemia, primary myelofibrosis) (edition 2018). Russian Journal of Hematology and Transfusiology. 2018;63(3):275–315. doi: 10.25837/HAT.2019.51.88.001. (In Russ)]

  2. Arber DA, Orazi А, Hasserjian R., et al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016;127(20):2391–405. doi: 10.1182/blood-2016-03-643544.

  3. Меликян А.Л., Суборцева И.Н. Материалы 57-го конгресса Американского гематологического общества (декабрь 2015 г., Орландо). Клиническая онкогематология. 2016;9(2):218–28.

    [Melikyan AL, Subortseva IN. Materials of the 57th Annual Meeting of the American Society of Hematology (December, 2015; Orlando). Clinical oncohematology. 2016;9(2):218–28. (In Russ)]

  4. Passamonti F, Merli M, Caramazza D, et al. Clinical Predictors of Outcome in MPN. Hematol Oncol Clin N Am. 2012;26(5):1101–16. doi: 10.1016/j.hoc.2012.07.009.

  5. Reilly JT, McMullin MF, Beer PA, et al. Guideline for the diagnosis and management of myelofibrosis. Br J Haematol. 2012;158(4):453–71. doi: 10.1111/j.1365-2141.2012.09179.x.

  6. Patient-reported outcomes in hematology. EHA SWG “Quality of life and Symptoms”. Forum Service Editore. Genoa; 2012. 206 p.

  7. Scherber R, Dueck AC, Johansson P, et al. The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF): international prospective validation and reliability trial in 402 patients. Blood. 2011;118(2):401–8. doi: 10.1182/blood-2011-01-328955.

  8. Emanuel RM, Dueck AC, Geyer HL, et al. Myeloproliferative Neoplasm (MPN) Symptom Assessment Form Total Symptom Score: Prospective International Assessment of an Abbreviated Symptom Burden Scoring System Among Patients With MPNs. J Сlin Oncol. 2012;30(33):4098–103. doi: 10.1200/jco.2012.42.3863.

  9. NCCN Clinical Practice Guidelines in Oncology. Myeloproliferative Neoplasms. Version 2.2019 — October 29, 2018. Available from: http://www.gaca.org.cn/uploadfolder/files/201903/ny27_930697.pdf (accessed 28.03.2020).

  10. Barosi G, Mesa R, Finazzi G, et al. Revised response criteria for polycythemia vera and essential thrombocythemia: an ELN and IWG-MRT consensus project. Blood. 2013;121(23):4778–81. doi: 10.1182/blood-2013-01-478891.

  11. Bullinger M, Power MJ, Aaronson NK, et al. Creating and evaluating cross-cultural instruments. In: Spilker B, ed. Quality of Life and Pharmacoeconomics in Clinical Trials. Philadelphia: Lippincott-Raven; 1996. pp. 659–68.

  12. Aaronson N, Alonso J, Burnam A, et al. Assessing health status and quality of life instruments: attributes and review. Qual Life Res. 2002;11(3):193–205.

  13. Beaton DE, Bombardier C, Guillemin F, et al. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine. 2000;25(24):3186–91. doi: 10.1097/00007632-200012150-00014.

  14. Cull A, Sprangers M, Bjordal K, et al. Translation Procedure. EORTC Monograph. Brussels; 1998. 26

  15. Ионова Т.И. Принципы языковой и культурной адаптации опросников оценки качества жизни. Вестник Межнационального центра исследования качества жизни. 2018;31–32:12–7.

    [Ionova Principles of linguistic and cultural adaptation of life quality assessment forms. Vestnik Mezhnatsional’nogo tsentra issledovaniya kachestva zhizni. 2018;31–32:12–7. (In Russ)]

  16. Ионова Т.И., Виноградова О.Ю., Ефремова Е.В. и др. Языковая и культурная адаптация русской версии инструмента для оценки симптомов у пациентов с миелопролиферативными новообразованиями — МПН10. Вестник Межнационального центра исследования качества жизни. 2019;33–34:19–30.

    [Ionova TI, Vinogradova OYu, Efremova EV, et al. Linguistic and cultural adaptation of the Russian version of the instrument for symptom assessment in patients with myeloproliferative neoplasms — MPN10. Vestnik Mezhnatsional’nogo tsentra issledovaniya kachestva zhizni. 2019;33–34:19–30. (In Russ)]

  17. Guidelines for Best Practice in Cross-Cultural Surveys. Available from: https://ccsg.isr.umich.edu/images/PDFs/CCSG_Full_Guidelines_2016_Version.pdf (accessed 28.03.2020).