A Wearable System Based on Multiple Magnetic and Inertial Measurement Units for Spine Mobility Assessment: A Reliability Study for the Evaluation of Ankylosing Spondylitis.

Spinal mobility assessment is essential for the diagnostic of patients with ankylosing spondylitis. BASMI is a routine clinical evaluation of the spine; its measurements are made with goniometers and tape measures, implying systematic errors, subjectivity, and low sensitivity. Therefore, it is crucial to develop better mobility assessment methods. The design, implementation, and evaluation of a novel system for assessing the entire spine's motion are presented. It consists of 16 magnetic and inertial measurement units (MIMUs) communicated wirelessly with a computer. The system evaluates the patient's movements by implementing a sensor fusion of the triaxial gyroscope, accelerometer, and magnetometer signals using a Kalman filter. Fifteen healthy participants were assessed with the system through six movements involving the entire spine to calculate continuous kinematics and maximum range of motion (RoM). The intrarater reliability was computed over the observed RoM, showing excellent reliability levels (intraclass correlation >0.9) in five of the six movements. The results demonstrate the feasibility of the system for further clinical studies with patients. The system has the potential to improve the BASMI method. To the best of our knowledge, our system involves the highest number of sensors, thus providing more objective information than current similar systems.

Preliminary tests of an Inertial Measurement Units based System for Spine mobility assessment in patients with Ankylosing Spondylitis.

This paper presents the preliminary tests of a novel system prototype for the physical assessment of mobility in patients with Ankylosing Spondylitis (AS). The system combines multi-inertial sensors arrays with Kalman Filters-based pose estimation for monitoring spine mobility in patients with AS. This system allows detecting movements with more reliable information than the manual clinical evaluation.

Assessment of SpondyloArthritis International Society (ASAS) Consensus on Spanish Nomenclature for Spondyloarthritis. / Consenso ASAS en nomenclatura en español para las espondiloartritis.

OBJECTIVE: To develop a consensus to standardize the use of Spanish terms, abbreviations and acronyms in the field of spondyloarthritis (SpA). METHODS: An international task force comprising all native Spanish-speaking Assessment of SpondyloArthritis International Society (ASAS) members, the executive committee of Grupo para el estudio de la Espondiloartritis de la Sociedad Española de Reumatología (GRESSER), two methodologists, two linguists from the Real Academia Nacional de Medicina de España (RANM) and two patients from the Spanish Coordinator of Spondylitis Associations (CEADE) was established. A literature review was performed to identify the conflicting terms/abbreviations/acronyms in SpA. This review examined written sources in Spanish including manuscripts, ICF and ICD, guidelines, recommendations and consensuses. This was followed by a nominal group meeting and a three-round Delphi. The recommendations from the RANM based on the Panhispanic dictionary were followed throughout the process. RESULTS: Consensus was reached for 46 terms, abbreviations or acronyms related to the field of SpA. A Spanish translation was accepted for 6 terms and 6 abbreviations to name or classify the disease, and for 6 terms and 4 abbreviations related to SpA. It was agreed not to translate 15 acronyms into Spanish. However, when mentioning them, it was recommended to follow this structure: type of acronym in Spanish and acronym and expanded form in English. With regard to 7 terms or abbreviations attached to acronyms, it was agreed to translate only the expanded form and a translation was also selected for each of them. CONCLUSIONS: Through this standardization, it is expected to establish a common use of the Spanish nomenclature for SpA. The implementation of this consensus across the community will be of substantial benefit, avoiding misunderstandings and time-consuming processes.

The Mexican Spanish version of the Juvenile Arthritis Multidimensional Assessment Report (JAMAR).

The Juvenile Arthritis Multidimensional Assessment Report (JAMAR) is a new parent/patient reported outcome measure that enables a thorough assessment of the disease status in children with juvenile idiopathic arthritis (JIA). We report the results of the cross-cultural adaptation and validation of the parent and patient versions of the JAMAR in the Mexican Spanish language. The reading comprehension of the questionnaire was tested in 10 JIA parents and patients. Each participating centre was asked to collect demographic, clinical data and the JAMAR in 100 consecutive JIA patients or all consecutive patients seen in a 6-month period and to administer the JAMAR to 100 healthy children and their parents. The statistical validation phase explored descriptive statistics and the psychometric issues of the JAMAR: the 3 Likert assumptions, floor/ceiling effects, internal consistency, Cronbach's alpha, interscale correlations, test-retest reliability, and construct validity (convergent and discriminant validity). A total of 100 JIA patients (16% systemic, 16% oligoarticular, 30% RF positive polyarthritis, 38% other categories) and 99 healthy children, were enrolled at the paediatric rheumatology department of the Hospital General de Mexico. The JAMAR components discriminated well healthy subjects from JIA patients. However, there was no significant difference between healthy subjects and their affected peers in school related problem variable. All JAMAR components revealed good psychometric performances. In conclusion, the Mexican Spanish version of the JAMAR is a valid tool for the assessment of children with JIA and is suitable for use both in routine clinical practice and clinical research.

The Paraguayan Spanish version of the Juvenile Arthritis Multidimensional Assessment Report (JAMAR).

The Juvenile Arthritis Multidimensional Assessment Report (JAMAR) is a new parent/patient reported outcome measure that enables a thorough assessment of the disease status in children with juvenile idiopathic arthritis (JIA). We report the results of the cross-cultural adaptation and validation of the parent and patient versions of the JAMAR in the Paraguayan Spanish language. The reading comprehension of the questionnaire was tested in 10 JIA parents and patients. Each participating centre was asked to collect demographic, clinical data and the JAMAR in 100 consecutive JIA patients or all consecutive patients seen in a 6-month period and to administer the JAMAR to 100 healthy children and their parents. The statistical validation phase explored descriptive statistics and the psychometric issues of the JAMAR: the 3 Likert assumptions, floor/ceiling effects, internal consistency, Cronbach's alpha, interscale correlations, and construct validity (convergent and discriminant validity). A total of 51 JIA patients (2% systemic, 27.4% oligoarticular, 37.2% RF negative polyarthritis, 33.4% other categories) and 100 healthy children, were enrolled. The JAMAR components discriminated well healthy subjects from JIA patients. Notably, there was no significant difference between healthy subjects and their affected peers in the school-related problem variable. All JAMAR components revealed good psychometric performances. In conclusion, the Paraguayan Spanish version of the JAMAR is a valid tool for the assessment of children with JIA and is suitable for use both in routine clinical practice and clinical research.

Assessment of clinical efficacy and safety in a randomized double-blind study of etanercept and sulfasalazine in patients with ankylosing spondylitis from Eastern/Central Europe, Latin America, and Asia.

Despite the demonstrated efficacy of etanercept for the treatment of ankylosing spondylitis (AS), sulfasalazine is often prescribed, especially in countries with limited access to biologic agents. The objective of this subset analysis of the ASCEND trial was to compare the efficacy of etanercept and sulfasalazine in treating patients with AS from Asia, Eastern/Central Europe, and Latin America. A total of 287 patients, 190 receiving etanercept 50 mg once weekly and 97 receiving sulfasalazine 3 g daily, from eight countries were included in this subset analysis. Differences in disease activity and patient-reported outcomes assessing health-related quality-of-life (HRQoL) parameters in response to treatment were analyzed using the Cochran-Mantel-Haenszel test for categorical efficacy endpoints and analysis of covariance model for continuous variables. At week 16, a significantly greater proportion of patients receiving etanercept achieved ASAS20 (79.0 %) compared with patients receiving sulfasalazine (61.9 %; p = 0.002). At week 16, treatment with etanercept also resulted in significantly better responses than sulfasalazine for ASAS40 (64.7 vs. 35.1 %; p < 0.001), ASAS5/6 (48.1 vs. 26.3 %; p < 0.001), proportion of patients achieving 50 % response in Bath AS Disease Activity Index (65.8 vs. 42.3 %; p < 0.001), partial remission (35.3 vs. 17.5 %; p = 0.002), and all HRQoL parameters. Both treatments were well tolerated. Etanercept was significantly more effective than sulfasalazine in the treatment of patients with AS from Asia, Central/Eastern Europe, and Latin America.

The Social Gap Index and the prevalence of osteoarthritis in the community: a cross-sectional multilevel study in Mexico.

Multilevel studies have gained importance for highlighting social inequalities in health. These associations have been reported previously in diseases such as arthritis and chronic pain. We conducted a cross-sectional study using multilevel analysis to identify individual and contextual factors associated with the variation of prevalence of osteoarthritis (OA) in the Mexican population. The sample included 17,566 individuals of which 10,666 (60.7%) were women. The relationship between individual and contextual factors and OA were analyzed with a multilevel strategy. From the total population, 1,681 individuals had OA. Multilevel analysis showed that individual variables such as female gender (odds ratio (OR) = 1.3, 95% confidence interval (CI) 1.1, 1.4), age range 55-65 years (OR = 1.6, 95% CI 1.3, 2.0), musculoskeletal pain in the last 7 days (OR = 2.6, 95% CI 2.3, 3.0), and use of pain treatments (OR = 1.4, 95% CI 1.2, 1.7) were associated with OA. At the regional level, the Social Gap Index (SGIx) was associated with the diagnosis of OA (coefficient 0.5, 95% CI 0.2-1.1). The SGIx contextual variable was positively associated with the regional prevalence of OA and the variation in prevalence of OA in different regions. The larger the social gap, the greater the variation in OA prevalence. These factors were independently associated with the prevalence of OA: female gender, pain intensity, physical limitation, and the use of pain treatments were individual variables associated with OA. The association between OA prevalence and regional variations with SGIx reflects inequities in health provisions that should be considered in health programs.

Characterization of knee osteoarthritis in Latin America. A comparative analysis of clinical and health care utilization in Argentina, Brazil, and Mexico.

BACKGROUND: The burden of knee osteoarthritis (OA) in Latin America is unknown. OBJECTIVE: To determine the demographic, clinical, and therapeutic characteristics of patients with OA in Argentina, Brazil, and Mexico. MATERIAL AND METHODS: This is an observational, cross-sectional study of patients with symptomatic knee OA referred from first care medical centers to Rheumatology departments. RESULTS: We included 1210 patients (Argentina 398, Brazil 402, Mexico 410; mean age 61.8 [12] years; 80.8% females). Knee OA pain lasted for 69 months; the duration and severity of the last episode were 190 days and (SD 5.2 [3.3]; 74% had functional limitations, but very few patients lost their job because of knee OA. Around 71% had taken medications, but 63% relied on their own pocket to afford knee OA cost. Most demographic and clinical variables differed across countries, particularly the level of pain, disability, treatment, and access to care. The variable country of origin influenced the level of pain, disability, and NSAIDs use in logistic regression models; age, pain, treatment, and health care access influenced at least 2 of the models. CONCLUSIONS: The burden of knee OA in Latin American depends on demographic, clinical, and therapeutic variables. The role of such variables differs across countries. The level of certain variables is significantly influenced by country of origin and health care system.

Current therapies in rheumatoid arthritis: a Latin American perspective.

Rheumatoid arthritis (RA) is a systemic inflammatory disease affecting the synovium of joints, tendons, and some extra-articular sites. RA prevalence in Latin America ranges from 0.4 to 1.6%. Early treatment of RA translates into a substantial reduction in the cost to society. In light of this, early disease clinics are being established in some countries. Barriers to RA management, such as delay in referral to rheumatologists and limited access to therapy, have been identified. Evidence-based treatment guidelines have been adapted by countries according to their own situations. The need for keeping accurate records of biologics prescribed has been addressed by biologic registries, thereby contributing toward a better understanding of rheumatic diseases and their treatment. Current biologics include the tumor necrosis factor (TNF)-α inhibitors (etanercept, infliximab, and adalimumab), B-cell depletion agent (rituximab), interleukin-6 receptor blocker (tocilizumab), and T-cell co-stimulatory blocker (abatacept). Future therapies include kinase inhibitors (tofacitinib and fostamatinib), alternative TNF-α inhibitors (golimumab and certolizumab), and biosimilars.

Catastrophic health expenses and impoverishment of households of patients with rheumatoid arthritis.

BACKGROUND: The cost of certain diseases may lead to catastrophic expenses and impoverishment of households without full financial support by the state and other organizations. OBJECTIVE: To determine the socioeconomic impact of the rheumatoid arthritis (RA) cost in the context of catastrophic expenses and impoverishment. PATIENTS AND METHODS: This is a cohort-nested cross-sectional multicenter study on the cost of RA in Mexican households with partial, full, or private health care coverage. Catastrophic expenses referred to health expenses totaling >30% of the total household income. Impoverishment defined those households that could not afford the Mexican basic food basket (BFB). RESULTS: We included 262 patients with a mean monthly household income (US dollars) of $376 (0­18,890.63). In all, 50.8%, 35.5%, and 13.7% of the patients had partial, full, or private health care coverage, respectively. RA annual cost was $ 5534.8 per patient (65% direct cost, 35% indirect). RA cost caused catastrophic expenses in 46.9% of households, which in the logistic regression analysis were significantly associated with the type of health care coverage (OR 2.7, 95%CI 1.6­4.7) and disease duration (OR 1.024, 95%CI 1.002­1.046). Impoverishment occurred in 66.8% of households and was associated with catastrophic expenses (OR 3.6, 95%CI 1.04­14.1), high health assessment questionnaire scores (OR 4.84 95%CI 1.01­23.3), and low socioeconomic level (OR 4.66, 95%CI 1.37­15.87). CONCLUSION: The cost of RA in Mexican households, particularly those lacking full health coverage leads to catastrophic expenses and impoverishment. These findings could be the same in countries with fragmented health care systems.

The assessment of the spondyloarthritis international society concept and criteria for the classification of axial spondyloarthritis and peripheral spondyloarthritis: A critical appraisal for the pediatric rheumatologist.

This review refers to the origin and current state of the assessment of the SpondyloArthritis International Society (ASAS) criteria for the classification of axial and peripheral spondyloarthritis (SpA) and the possible implications in the pediatric population. The ASAS criteria evolved from the idea that the earlier the recognition of patients with ankylosing spondylitis, the better the efficacy of tumor necrosis factor blockers. Strategies included the development of new concepts, definitions, and techniques for the study of clinical signs and symptoms. Of relevance, the new definition of inflammatory back pain (IBP) and the introduction of sacroiliitis by magnetic resonance imaging represented the most important advance in the early identification of AS in the "pre-radiographic stage" of the disease. AS is considered in this paper as a disease continuum with symptoms depending on age at onset. The application of those specific strategies in children and adolescents with SpA seems limited because the most important manifestation in the early stage of disease is not IBP, but peripheral arthritis and enthesitis. In this instance, the logical approach to juvenile onset SpA according to ASAS criteria should not be through the axial criteria but rather the peripheral set of criteria.

Development and initial validation of composite parent- and child-centered disease assessment indices for juvenile idiopathic arthritis.

OBJECTIVE: To develop and validate a parent-centered and a child-centered composite disease assessment index for juvenile idiopathic arthritis (JIA): the Juvenile Arthritis Parent Assessment Index (JAPAI) and the Juvenile Arthritis Child Assessment Index (JACAI), respectively. METHODS: The JAPAI and the JACAI include 4 measures: parent/child rating of overall well-being, pain, physical function, and health-related quality of life (HRQOL). Validation analyses were conducted on nearly 5,000 patients and included assessment of construct validity, discriminant validity, responsiveness to change, and reliability. Besides the 4-item version, a 3-item version of both indices, which did not include HRQOL, was tested. RESULTS: The JAPAI and the JACAI demonstrated good construct validity, yielding high correlations with the Juvenile Arthritis Disease Activity Score and moderate correlations with physician global rating and joint counts. Correlations obtained for the JAPAI and the JACAI and for the 4-item and the 3-item versions were comparable. Factorial analysis by principal component analysis showed that both indices are monodimensional. Both the JAPAI and JACAI discriminated well between different disease states and courses and between different levels of American College of Rheumatology Pediatric criteria in a clinical trial, and revealed fair responsiveness to clinical change. Internal consistency was satisfactory, with a Cronbach's alpha of >0.80 in all but 1 of the patient samples tested. CONCLUSION: The JAPAI and the JACAI were found to be valid instruments for assessment of disease status in JIA and suitable surrogates of physicians' evaluations. Both indices are potentially applicable in clinical practice, observational studies, and therapeutic trials.

[Social costs of the most common inflammatory rheumatic diseases in Mexico from the patient's perspective]. / El costo de las principales enfermedades reumáticas inflamatorias desde la perspectiva del paciente en México.

OBJECTIVE: To estimate the social costs of rheumatoid arthritis (RA), ankylosing spondylitis (AS), and gout from the patient's perspective. METHODS: We carried out a cross-sectional analysis of the cost and resource utilization of 690 RA, AS, and gout patients from 10 medical centers and private facilities in five cities of Mexico. The information was obtained from the baseline of a dynamic cohort. We estimated out-of-pocket expenses, institutional direct costs, and direct medical costs. RESULTS: The mean (SD) annual out-of-pocket expense (USD) was $610.0 ($302.2) for RA, $578.6 ($220.5) for AS, and $245.3 ($124.0) for gout. Figures correspond to 15%, 9.6%, and 2.5% of the family income. They also represented 26.1%, 25.3%, and 24.4% of the total annual cost per RA, AS, and gout patients, respectively. The expected direct institutional patient/year costs were 1,724.2 for RA, $1,710.8 for AS, and $760.7 for gout. The total patient annual costs were $2,334.3 for RA, $2,289.4 for AS, and $1,006.1 for gout. Most out-of-pocket expenses were used to purchase drugs, pay for laboratory tests, imaging studies, and alternative therapies. CONCLUSIONS: From the patient's perspective, the cost of RA, AS, and gout represents 25% of direct medical costs. The cost of RA is higher than that for AS and gout.

El costo de las principales enfermedades reumáticas inflamatorias desde la perspectiva del paciente en México / Social costs of the most common inflammatory rheumatic diseases in Mexico from the patient's perspective

Objetivo: Estimar el costo de la artritis reumatoide (AR), la espondilitis anquilosante (EA) y la gota, desde la perspectiva del paciente. Métodos: Análisis transversal de los costos y utilización de recursos de 690 pacientes con AR, EA y gota, de 10 departamentos de centros hospitalarios y consultorios privados de cinco ciudades del país, al momento de ser incluidos en una cohorte dinámica. Se incluye una estimación de los gastos de bolsillo, los costos médicos directos institucionales y el costo médico directo real. Resultados: El gasto de bolsillo promedio (SD) anual (en dólares) en pacientes con AR ascendió a $610.0 ($302.2), en EA a $578.6 ($220.5) y en gota a $245.3 ($124.0), lo que equivalió a 15, 9.6 y 2.5% del ingreso familiar, respectivamente. El gasto de bolsillo representó 26.1% del costo total anual por paciente con AR, 25.3% con EA y 24.4% con gota. Los costos directos institucionales esperados por paciente/año con AR fueron de $1724.2, con EA de $1710.8 y con gota de $760.7. El costo total anual por paciente con AR fue de $2334.3, con EA de $2289.4 y con gota de $1006.1. Los componentes del gasto de bolsillo de mayor cuantía fueron los medicamentos, exámenes de laboratorio y gabinete y las terapias alternativas. Conclusiones: Se concluye que desde la perspectiva del paciente, el costo de la AR, EA y gota equivale a la cuarta parte del costo médico directo. La AR es la enfermedad que mayor gasto implica.

OBJECTIVE: To estimate the social costs of rheumatoid arthritis (RA), ankylosing spondylitis (AS), and gout from the patient's perspective. METHODS: We carried out a cross-sectional analysis of the cost and resource utilization of 690 RA, AS, and gout patients from 10 medical centers and private facilities in five cities of Mexico. The information was obtained from the baseline of a dynamic cohort. We estimated out-of-pocket expenses, institutional direct costs, and direct medical costs. RESULTS: The mean (SD) annual out-of-pocket expense (USD) was $610.0 ($302.2) for RA, $578.6 ($220.5) for AS, and $245.3 ($124.0) for gout. Figures correspond to 15%, 9.6%, and 2.5% of the family income. They also represented 26.1%, 25.3%, and 24.4% of the total annual cost per RA, AS, and gout patients, respectively. The expected direct institutional patient/year costs were 1,724.2 for RA, $1,710.8 for AS, and $760.7 for gout. The total patient annual costs were $2,334.3 for RA, $2,289.4 for AS, and $1,006.1 for gout. Most out-of-pocket expenses were used to purchase drugs, pay for laboratory tests, imaging studies, and alternative therapies. CONCLUSIONS: From the patient's perspective, the cost of RA, AS, and gout represents 25% of direct medical costs. The cost of RA is higher than that for AS and gout.

Validation of the Health Assessment Questionnaire disability index in patients with gout.

OBJECTIVE: To assess the psychometric properties of the Health Assessment Questionnaire (HAQ) disability index (DI) in patients with gout. METHODS: This study was conducted in a multicenter cohort of patients with gout whose data were collected at baseline (time 0) and 6 months later (time 6). Reliability was assessed by test-retest reliability (intraclass correlation coefficient [ICC]) and internal consistency (Cronbach's alpha coefficient). Construct validity was assessed with convergent validity (HAQ DI correlation with Short Form 36 [SF-36]) and discriminative validity (HAQ DI correlation with clinical features). Sensitivity to change was determined by comparing HAQ DI time 0 versus HAQ DI time 6 (percentage of change, effect size, smallest real difference [SRD], and Guyatt's responsiveness index [GRI]). RESULTS: We included 206 patients (96.6% men, mean +/- SD age and disease duration 56.3 +/- 12.4 years and 9.3 +/- 8.5 years, respectively). Of these, 52.4% had joint pain, 22.8% swelling, 32.5% reduced joint mobility, and 36.9% tophi. The mean HAQ DI score was 0.59 +/- 0.77 (95% confidence interval [95% CI] 0.49-0.70). ICC (n = 36, evaluations at baseline and 5 days later) was 0.76. Cronbach's alphas were 0.91 (95% CI 0.88-0.92, P = 0.000) for the 20 HAQ DI items and 0.93 (95% CI 0.92-0.94, P = 0.000) for the 8 HAQ DI categories. The HAQ DI correlated in predictable ways with SF-36 subscales and clinical variables, and discriminated between subgroups with and without any joint pain, swelling, and tophi. Concerning sensitivity to change (n = 167), the difference between HAQ DI time 0 and HAQ DI time 6 was 0.31 +/- 0.58 (effect size 0.62, SRD 0.59, and GRI 1.91). DeltaHAQ DI correlated with Deltapain (r = 0.349, P = 0.000). CONCLUSION: The HAQ DI is a valid and reliable measure of functioning in patients with gout.