The paper discusses the process for validation of the Russian-language EQ-5D-5L version to assess quality of life. According to international and national guidelines, the primary goal of treating spondyloarthritis (SpA) is to preserve the quality of life (QOL) of a patient as long as possible, by achieving control of the main symptoms of the disease and inflammation, by preventing the development and progression of structural changes in the locomotor system, and by preserving/normalizing the patient's functional activity and social adaptation. QOL is the integral characteristic of the physical, psychological, social and emotional status of the patient, which is assessed on the basis of his subjective perception. At the moment, there are no generally accepted national tools for assessing QOL in Russia, so the problem of adaptation and validation of international questionnaires is very actual.Objective: to evaluate the psychometric properties of the Russian-language EQ-5D-5L version in patients with SpA.Subjects and methods. Examinations were made in 163 patients older than 18 years with axial or peripheral SpA, who met the Assessment of Spondyloarthritis International Society (ASAS) criteria. The disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS); their functional status was estimated by the Bath Ankylosing Spondylitis Functional Index (BASFI), and spinal mobility was evaluated by the Bath Ankylosing Spondylitis Metrology Index (BASMI). The ASAS Health Index (HI) was used to comprehensively analyze the impact of SpA on the patient's health. The EQ-5D-5L version was employed for the first time in Russia to assess the quality of life of patients. Its main psychometric properties, such as reproducibility, validity, sensitivity, were evaluated.Results and discussion. The median age of the patients was 39.50 [28.00; 48.00] years. Among them, there were 64.8% of men. The median value of EQ-5D (a 5L version) was 0.53 [0.29; 0.65]. There were statistically significant relationships between the EQ-5D-5L values and BASDAI, BASFI, ASDAS, BASMI, ASAS HI, and the SF-36 questionnaire for QOL assessment. The test-retest reliability study showed that the internal consistency (Cronbach's alpha) was 0.96. The median value of the EQ-5D-5L was 0.55 [0.37; 0.63] at the first visit and 0.60 [0.40; 0.69] at the second visit after prescribing therapy (p = 0.01).Conclusion. The validation has indicated that the EQ-5D-5L version is a reliable, change-sensitive, easy-to-use, and physician-patient-friendly tool to assess QOL.
ASAS health index (ASAS HI) is a comprehensive tool developed on the basis of the international system of ICF (the International Classification of Functioning, Disability and Health) to quantify the health of patients with spondyloarthritis (SPA), including ankylosing spondylitis (AS). ASAS HI is a questionnaire containing 17 questions, each related to a specific ICF pool (pain, emotions, sleep, sexual function, mobility, self-care and communication). ASAS HI additionally includes 9 questions (ASAS EF Item Set) to assess the impact of environmental factors on the health of the patient with SPA. The aim is a Russian translation and adaptation of the ASAS HI (including ASAS EF Item Set). Material and methods. Translation of ASAS HI and ASAS EF Item Set from English into Russian and its adaptation were carried out in five stages: the stage of direct translation; the stage of synthesis of translations and formation of the Russian version; the stage of reverse translation from Russian into English; the stage of comparison of the original English-language questionnaire with the result of reverse translation and the formation of the final Russian-language version; field test. Results and discussion. Three researchers performed an independent translation of ASAS HI (including ASAS EF Item Set), after which the fourth researcher created and agreed on a single Russian version of the questionnaire. Then two volunteers, for whom English is the main language, performed a reverse translation of ASAS HI from Russian into English (reverse translation). An independent researcher has compared the original and the resulting reverse translated English version of the ASAS HI, and then the three translators performed the joint correction of the text of the three questions, differing in English-language versions. The obtained second Russian-language version of ASAS HI (including ASAS EF Item Set) was tested by 10 patients with SPA: AS – 60%; non-radiological axial spondylitis (NR axSPA) – 40%, men – 60%; mean age – 32±12 years; duration of symptoms – 7.5±2.2 years; BASDAI index – 3.39±3.04; ASAS HI – 6,96±3,35.The average time to fill the questionnaire – 2,2±1,18 min. Patients rated the Russian version of the questionnaire as clear, easy to fill in and comprehensively characterizing health problems related to SPA. The results of testing Russian-speaking patients are comparable with the results obtained in testing 206 patients with SPA from 19 non-English-speaking and 4 English-speaking countries (AS – 65%; men – 59.7%; mean age – 42.4±13.9 years; duration of symptoms – 11.2±11.0 years; BASDAI – 3.8±2.3; ASAS HI – 7.1±4.4; filling time – 2.6±1.6 min). Conclusion. During the study translation and adaptation of the Russian version of ASAS HI, which is a tool for comprehensive assessment of health and function of patients with SPA, including AS were performed.
The Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI) is a comprehensive tool for quantifying the health of patients with axial (ax) spondyloarthritis (SpA), including ankylosing spondylitis (AS). ASAS HI was developed on the basis of the International Classification of Functioning, Disability, and Health (ICF). The questionnaire contains 17 questions, each of which is associated with a specific ICF pool (pain, emotions, sleep, sexual function, ambulation, self-care, and communication).Objective: to study the psychometric properties of the Russian-language version of ASAS HI.Subjects and methods. Examinations were made in 245 patients older than 18 years with axSpA or peripheral SpA, who met the ASAS criteria. The main psychometric properties of a questionnaire, such as validity, reliability (reproducibility), and sensitivity, were evaluated. SpA activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS); the functional status of the patients was estimated by the Bath Ankylosing Spondylitis Functional Index (BASFI), and their spinal mobility was evaluated by the Bath Ankylosing Spondylitis Metrology Index (BASMI). The short-form 36 (SF-36) health questionnaire and the 5-dimensional EQ-5D version (EuroQoL) were used to assess quality of life in SpA patients. Patient satisfaction with their health status was estimated using the patient acceptable symptom state (PASS) index.Results and discussion. The median age of the patients enrolled in the investigation was 39.5 [28.00; 48.00] years; disease duration – 102.5 [23.0; 196.5] months; there were 64.58% of men were and 78% of HLA-B27 positive patients. The median scores were for: BASDAI, 5.40 [3.20; 6.80]; ASDAS, 3.19 [2.55; 4.15]; BASFI, 5.60 [2.60; 7.50]; BASMI, 4.20 [3.00; 6.60]; ASAS HI, 9.00 [7.00; 12.00]; ASAS EF Items Set, 4.00 [3.00; 7.00]. There were statistically significant relationships between ASAS HI scores and C-reactive protein levels (Spearman correlation coefficient r=0.56), BASDAI (r=0.62), BASFI (r=0.67), ASDAS (r=0.38), BASMI (r=0.46), and patient's global assessment on a visual analogue scale (VAS) (r=0.49; p<0.05 for all measures). The ASAS EF Items Set scores correlated with the main clinical characteristics of the patients. There were statistically significant relationships between the ASAS HI/EF Items Set scores and the latter of eight SF-36 scales and the EQ-5D ques tionnaire. Statistically significant differences in ASAS HI scores were found in patients with positive and negative PASS indices (the median value of ASAS HI was 6.89 [3.00; 10.00] and 9.20 [7.00; 12.00], respectively; p=0.000086). Cronbach's internal consistency for ASAS HI was 0.988. There were statistically significant differences in ASAS HI scores before and after treatment (9 [7; 12] and 6 [3; 10], respectively; p=0.00025).Conclusion. This study confirmed validity, reproducibility, and sensitivity to changes of the Russian-language version of ASAS HI for patients in the Russian Federation.
Spondyloarthritides (SpAs) is a group of chronic inflammatory diseases of the spine, joints, and entheses characterized by common clinical, radiological, and genetic features. According to international guidelines, one of the main goals of SpA treatment is to ensure the longest possible preservation of the patient's quality of life (QOL). The use of biological agents (BAs) allows rapid clinical improvement and positively affects QOL in patients.Objective: to evaluate the efficacy of BAs on QOL in patients with SpA in real clinical practice.Patients and methods. A total of 280 patients with SpA were examined. The inclusion criteria were ≥18 years of age; compliance of the clinical picture of the disease with the ASAS criteria for axial SpA (2009) or peripheral SpA (2011); and signing the informed consent form. Disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS); the functional status of the patients was estimated by the Bath Ankylosing Spondylitis Functional Index (BASFI), and their spinal mobility was evaluated by the Bath Ankylosing Spondylitis Metrology Index (BASMI); ASAS HI was used to comprehensively evaluate the impact of SpA on the patient's health. The European QL EQ-5D-5L and the SF-36 questionnaire were applied to determine quality of life in the patients.Results and discussion. The patients' mean age was 40.19±11.9 years; there was a male preponderance (64%); the HLA-B7-pisitive patients were 78%. The median scores were 5.40 [3.12; 6.80] for BASDAI, 3.37 [2.58; 4.15] for ASDAS, 5.30 [2.60; 7.50] for BASFI, 4.00 [2.60; 6.15] for BASMI, and 9.00 [7.00; 12.00] for ASAS HI. Forty-four patients received a variety of BAs. Patients receiving and not receiving BAs were matched for age and gender; however, the patients on biological therapy (BT) had longer disease duration and lower disease activity according to the ASDAS. There were no statistically significantly difference between the two groups in disease activity according to the BASDAI and in functional disorders according to the BASFI; but there was a tendency towards lower values in the patients on BT. Comparison of QOL in the patients of the two groups revealed statistically significant differences in SF-36 pain scale scores (p=0.02) and EQ-5D-5L indicators (p<0.01).Conclusion. BT makes it possible to successfully achieve one of the main goals of treating patients with SpA, namely to preserve QOL. The patients receiving BAs had longer disease duration, while they were comparable to those not receiving this treatment in terms of the degree of functional disorders.
Увеит (воспаление сосудистой оболочки глаза) является одним из наиболее частых внескелетных проявлений спон-дилоартритов (СпА) -анкилозирующего спондилита (АС), псориатического артрита, воспалительных заболеваний ки-шечника (болезнь Крона, язвенный колит), болезни Бехче-та, ювенильных артритов [1,2]. Он является самым распро-страненным внескелетным проявлением АС (20-40% слу-чаев) [1,3]. Увеит при АС встречается почти в 200 раз чаще, чем при ревматоидном артрите [4]. В первой декаде XXI в. отмечено изменение представлений о гендерных особенно-стях АС -наблюдается быстрое увеличение доли женщин с АС [5][6][7][8]. В связи с этим появилось много данных об осо-бенностях поражения опорно-двигательного аппарата при АС у женщин [5][6][7][8]. В то же время особенности внескелет-ных проявлений АС у женщин изучены в меньшей степени и являются интересной междисциплинарной проблемой, затрагивающей разные аспекты внутренних болезней, рев-матологии и офтальмологии. Скудные знания о системных проявлениях болезни у лиц разного пола могут быть одной из причин поздней диагностики АС, особенно в случае, ко-
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