Нервно-мышечные болезни. 2022; 12: 17-25
Валидация опросника для оценки качества жизни пациентов с хронической приобретенной полинейропатией (Chronic Acquired Polyneuropathy – Patient Reported Index, CAP-PRI) в России
https://doi.org/10.17650/2222-8721-2022-12-3-17-25Аннотация
Введение. Хроническая воспалительная демиелинизирующая полинейропатия (ХВДП) – самая частая из иммуноопосредованных полинейропатий. Для ХВДП характерны многолетнее прогрессирующее или рецидивирующее течение, развитие неврологического дефицита и инвалидизации, в связи с чем важен мониторинг качества жизни пациентов. Представлены результаты 1‑го и 2‑го этапов валидации русскоязычной версии опросника Chronic Acquired Polyneuropathy – Patient Reported Index (CAP‑PRI) для оценки качества жизни у пациентов с иммуноопосредованными полинейропатиями.
Цель исследования – проведение валидации опросника CAP‑PRI у пациентов с ХВДП с разработкой его русскоязычной версии.
Материалы и методы. В исследование было включено 85 пациентов с ХВДП, диагностированной на основании критериев EAN / PNS 2021. На 1‑м этапе проведена лингвистическая валидация оригинальной англоязычной версии опросника согласно общепринятым рекомендациям: 2 русскоязычными профессиональными переводчиками в сфере медицины выполнен прямой перевод оригинальной англоязычной шкалы, обратный перевод осуществлен носителями языка с медицинским образованием. На 2‑м этапе валидации проводилось исследование психометрических показателей разработанного русскоязычного варианта.
Результаты. Разработана русскоязычная версия опросника CAP‑PRI с высоким уровнем надежности, содержательной валидности и чувствительности.
Заключение. Представленная официальная русскоязычная версия опросника для пациентов с хронической приобретенной полинейропатией (CAP‑PRI) рекомендована для отечественной клинической практики и научно‑исследовательской работы с целью оценки качества жизни пациентов. Дополнительно показана связь между улучшением качества жизни и уменьшением выраженности неврологического дефицита, степени инвалидизации и утомляемости (по результатам оценок по шкалам IRODS, NIS и FSS).
Список литературы
1. Broers M.C., Bunschoten C., Nieboer D. et al. Incidence and prevalence of chronic inflammatory demyelinating polyradiculoneuropathy: A systematic review and meta-analysis. Neuroepidemiology 2019;52(3–4):161–72. DOI: 10.1159/000494291
2. Van den Bergh P.Y.K., Doorn P.A., Hadden R.D.M. et al. European Academy of Neurology/Peripheral Nerve Society guideline on diagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy: Report of a joint Task Force – Second revision. J Periph Nerv Syst 2021;26(3):242–68. DOI: 10.1111/jns.12455
3. Mathey E.K., Park S.B., Hughes R.A.C. et al. Chronic inflammatory demyelinating polyradiculoneuropathy: from pathology to phenotype. J Neurol Neurosurg Psychiatry 2015;86(9):973–85. DOI: 10.1136/jnnp-2014-309697
4. Briani C., Cocito D., Campagnolo M. et al. Update on therapy of chronic immune-mediated neuropathies. Neurol Sci 2021. DOI: 10.1007/s10072-020-04998-y
5. Вуйцик Н.Б., Супонева Н.А., Чечеткин А.О. и др. Ультразвуковая нейровизуализация при хронической воспалительной демиелинизирующей полиневропатии. Анналы клинической и экспериментальной неврологии 2014;8(3):9–13. DOI: 10.17816/psaic177
6. Dyck P.J., Zimmerman B.R., Vilen T.H. et al. Nerve glucose, fructose, sorbitol, myo-inositol, and fiber degeneration and regeneration in diabetic neuropathy. New Engl J Med 1988;319(9):542–8. DOI: 10.1056/nejm198809013190904
7. Medical Research Council. Aids to the examination of the peripheral nervous system. HM Stationery Office, 1976. P. 70.
8. Merkies I.S.J., Schmitz P.I.M., van der Meche F.G.A. et al. Inflammatory Neuropathy Cause and Treatment (INCAT) group. Clinimetric evaluation of a new overall disability scale in immune mediated polyneuropathies. J Neurol Neurosurg Psychiatry 2002;72(5):596–601. DOI: 10.113/jnnp.72.5.596
9. Ware J.E., Sherbourne C.D. The MOS 36-Item short-form health survey. Med Care 1992;30(6):473–83.
10. Herdman M., Gudex C., Lloyd A., et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011;20(10):1727–36. DOI: 10.1007/s11136-011-9903-x32
11. Gwathmey K.G., Conaway M.R., Sadjadi R. et al. Construction and validation of the chronic acquired polyneuropathy patient-reported index (CAP-PRI): A disease-specific, health-related quality-of-life instrument. Muscle Nerve 2016;54(1):9–17. DOI: 10.1002/mus.24985
12. Gwathmey K.G., Sadjadi R., Horton W. et al. Validation of a simple disease-specific, quality-of-life measure for diabetic polyneuropathy. Neurology 2018;90(23):e2034–e2041. DOI:10.1212/wnl.0000000000005643
13. Bjelica B., Peric S., Gwathmey K. et al. Chronic Acquired Polyneuropathy Patient Reported Index (CAPPRI) in chronic inflammatory demyelinating polyradiculoneuropathy. J Periph Nerv Syst 2019;24(3):247–52. DOI: 10.1111/jns.12329
14. Sadjadi R., Peric S., Gwathmey K. et al. Psychometric longitudinal evaluation of the Chronic Acquired Polyneuropathy Patient Reported Index (CAPPRI) in patients with Chronic Inflammatory Demyelinating Polyneuropathy. Muscle Nerve 2021;63(1):84–8. DOI: 10.1002/mus.27089
15. Vu T., Anthony N., Alsina R. et al. Impact of subcutaneous immunoglobulin on quality of life in patients with chronic inflammatory demyelinating polyneuropathy previously treated with intravenous immunoglobulin. Muscle Nerve. 2021;63(3):1–6. DOI: 10.1002/mus.27345
16. Новик А.А., Ионова Т.И. Руководство по исследованию качества жизни в медицине. М.: ЗАО «Олма Медиа Групп», 2007. 320 с.
17. Guillemin F., Bombardier C., Beaton D. Recommendations for the cross-cultural adaptation of health status measures. J Clin Epidemiol 1993;46(12):1417–32. DOI: 10.1016/0895-4356(93)90142-n
18. Kadam P., Bhalerao S. Sample size calculation. Int J Ayurveda Res 2010;1(1):55. DOI: 10.4103/0974-7788.59946
19. Nunnaly J.C. Psychometric Theory. New York: Tata McGraw-Hill Education, 1994. P. 152.
Neuromuscular Diseases. 2022; 12: 17-25
Validation Chronic Acquired Polyneuropathy – Patient Reported Index (CAP-PRI) in Russia for CIDP patients
https://doi.org/10.17650/2222-8721-2022-12-3-17-25Abstract
Background. Chronic inflammatory demyelinating polyneuropathy (CIDP) is the most common immune‑mediated polyneuropathy. CIDP is characterized by a long‑term progressive or recurrent course of the disease and the development of neurological deficits and disability, it is important to assess the quality of life of patients. The paper presents the results of the first and second steps of validation of the Chronic acquired polyneuropathy – Patient Reported Index (CAP‑PRI) questionnaire designed to assess quality of life in patients with immune‑mediated polyneuropathy.
Aim. To develop the Russian version of the CAP‑PRI questionnaire.
Materials and methods. 85 patients with CIDP (according to EAN / PNS 2021 criteria) were enrolled. At the first step we conducted linguocultural validation according to the standard protocol. Two Russian‑speaking professional translators in the field of medicine performed direct translation of the original English‑language questionnaire, and the back translation was performed by native speakers with a medical background. At the second step the psychometric parameters were evaluated.
Results. The developed Russian version of the CAP‑PRI questionnaire demonstrated a high level of reliability, validity and sensitivity.
Conclusion. The Russian version of the CAP‑PRI questionnaire is recommended for clinical practice and research. In addition, the relationship between improved quality of life and the reduction of neurological deficits, disability and fatigue (as assessed by the IRODS, NIS and FSS scales) has been shown.
References
1. Broers M.C., Bunschoten C., Nieboer D. et al. Incidence and prevalence of chronic inflammatory demyelinating polyradiculoneuropathy: A systematic review and meta-analysis. Neuroepidemiology 2019;52(3–4):161–72. DOI: 10.1159/000494291
2. Van den Bergh P.Y.K., Doorn P.A., Hadden R.D.M. et al. European Academy of Neurology/Peripheral Nerve Society guideline on diagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy: Report of a joint Task Force – Second revision. J Periph Nerv Syst 2021;26(3):242–68. DOI: 10.1111/jns.12455
3. Mathey E.K., Park S.B., Hughes R.A.C. et al. Chronic inflammatory demyelinating polyradiculoneuropathy: from pathology to phenotype. J Neurol Neurosurg Psychiatry 2015;86(9):973–85. DOI: 10.1136/jnnp-2014-309697
4. Briani C., Cocito D., Campagnolo M. et al. Update on therapy of chronic immune-mediated neuropathies. Neurol Sci 2021. DOI: 10.1007/s10072-020-04998-y
5. Vuitsik N.B., Suponeva N.A., Chechetkin A.O. i dr. Ul'trazvukovaya neirovizualizatsiya pri khronicheskoi vospalitel'noi demieliniziruyushchei polinevropatii. Annaly klinicheskoi i eksperimental'noi nevrologii 2014;8(3):9–13. DOI: 10.17816/psaic177
6. Dyck P.J., Zimmerman B.R., Vilen T.H. et al. Nerve glucose, fructose, sorbitol, myo-inositol, and fiber degeneration and regeneration in diabetic neuropathy. New Engl J Med 1988;319(9):542–8. DOI: 10.1056/nejm198809013190904
7. Medical Research Council. Aids to the examination of the peripheral nervous system. HM Stationery Office, 1976. P. 70.
8. Merkies I.S.J., Schmitz P.I.M., van der Meche F.G.A. et al. Inflammatory Neuropathy Cause and Treatment (INCAT) group. Clinimetric evaluation of a new overall disability scale in immune mediated polyneuropathies. J Neurol Neurosurg Psychiatry 2002;72(5):596–601. DOI: 10.113/jnnp.72.5.596
9. Ware J.E., Sherbourne C.D. The MOS 36-Item short-form health survey. Med Care 1992;30(6):473–83.
10. Herdman M., Gudex C., Lloyd A., et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011;20(10):1727–36. DOI: 10.1007/s11136-011-9903-x32
11. Gwathmey K.G., Conaway M.R., Sadjadi R. et al. Construction and validation of the chronic acquired polyneuropathy patient-reported index (CAP-PRI): A disease-specific, health-related quality-of-life instrument. Muscle Nerve 2016;54(1):9–17. DOI: 10.1002/mus.24985
12. Gwathmey K.G., Sadjadi R., Horton W. et al. Validation of a simple disease-specific, quality-of-life measure for diabetic polyneuropathy. Neurology 2018;90(23):e2034–e2041. DOI:10.1212/wnl.0000000000005643
13. Bjelica B., Peric S., Gwathmey K. et al. Chronic Acquired Polyneuropathy Patient Reported Index (CAPPRI) in chronic inflammatory demyelinating polyradiculoneuropathy. J Periph Nerv Syst 2019;24(3):247–52. DOI: 10.1111/jns.12329
14. Sadjadi R., Peric S., Gwathmey K. et al. Psychometric longitudinal evaluation of the Chronic Acquired Polyneuropathy Patient Reported Index (CAPPRI) in patients with Chronic Inflammatory Demyelinating Polyneuropathy. Muscle Nerve 2021;63(1):84–8. DOI: 10.1002/mus.27089
15. Vu T., Anthony N., Alsina R. et al. Impact of subcutaneous immunoglobulin on quality of life in patients with chronic inflammatory demyelinating polyneuropathy previously treated with intravenous immunoglobulin. Muscle Nerve. 2021;63(3):1–6. DOI: 10.1002/mus.27345
16. Novik A.A., Ionova T.I. Rukovodstvo po issledovaniyu kachestva zhizni v meditsine. M.: ZAO «Olma Media Grupp», 2007. 320 s.
17. Guillemin F., Bombardier C., Beaton D. Recommendations for the cross-cultural adaptation of health status measures. J Clin Epidemiol 1993;46(12):1417–32. DOI: 10.1016/0895-4356(93)90142-n
18. Kadam P., Bhalerao S. Sample size calculation. Int J Ayurveda Res 2010;1(1):55. DOI: 10.4103/0974-7788.59946
19. Nunnaly J.C. Psychometric Theory. New York: Tata McGraw-Hill Education, 1994. P. 152.
