Qualitative validation of audiovisual educational material for use on rheumatoid arthritis patients.

Medication compliance is critical to achieve therapeutic efficacy in patients with rheumatoid arthritis; however, among other factors, low patient-health literacy plays a negative role. Therefore, the development and validation of audiovisual educational material with the participation of health specialists and patients could lead to an improved level of compliance with treatment, while favoring its acceptance. To design and validate audiovisual educational material generated by a multidisciplinary and participative group of patients and health specialists. This study was carried out using a sequential methodology, including qualitative and quantitative techniques: (1) a non-participative observational study with patients and a non-systematic literature search were performed to identify conceptual topics. (2) Pilot videos were qualitatively assessed by patients and health specialists (focus groups and expert committees). (3) Improved versions of seven videos were quantitatively evaluated by patients and specialists following qualitative criteria of attraction, understanding, involvement, acceptance and induction of action. 74 patients with RA, 10 rheumatologists, 4 pharmacists and 2 medical anthropologists participated in the different phases of validation. A total of seven videos lasting 3 min each were generated, incorporating the most relevant suggestions by patients and healthcare professionals. The final version of the videos led to a mean compliance of 96.04 ± 5.2%, according to a representative group of patients and a mean 89.6 ± 9.4%, according to health professionals. With the participation of both patients and health specialists, seven audiovisual educational video recordings were developed and validated, reaching high levels of compliance in accordance with international criteria.

Myositis-Specific Antibodies and Myositis-Associated Antibodies in Patients With Idiopathic Inflammatory Myopathies From the PANLAR Myositis Study Group.

BACKGROUND: Dermatomyositis (DM) and polymyositis (PM) are forms of idiopathic inflammatory myopathies (IIMs), which are associated with the production of autoantibodies that are useful in the diagnosis and prognosis of the disease. OBJECTIVE: The aim of this study was to determine the frequency of antinuclear autoantibodies (ANAs), myositis-specific autoantibodies (MSAs), and myositis-associated autoantibodies (MAAs) in 6 Latin American countries. METHODS: Two hundred ten patients with IIM were included in this cross-sectional study from 2014 to 2017: 112 from Mexico, 46 from Colombia, 20 from Peru, 16 from the Dominican Republic, 10 from Argentina, and 6 from Guatemala. Antinuclear autoantibodies were detected by indirect immunofluorescence on HEp-2 cells. MSAs and MAAs were tested by a line immunoassay method. Mann-Whitney U and χ2 tests were used for statistical analysis. RESULTS: Of the 210 IIM patients, 139 (66.2%) had DM, 59 (28%) PM, and 12 (5.7%) juvenile DM. The mean age was 43.5 (6-79 years); 158 (75.2%) were female, and 52 (24.8%) were male. The overall frequency of ANA was 60%. The most frequent patterns were fine speckled (AC-4) (78.3%) and cytoplasmic (AC-19) (6.45%). The most frequent MSA were anti-Mi-2 (38.5%) and anti-Jo-1 (11.9%). Anti-Mi-2 was more frequent in patients from Colombia (40.1%). The MAA more frequent were anti-Ro-52/TRIM21 (17.6%) and anti-PM-Scl75 (7.5%). CONCLUSIONS: This is the first study of ANA, MSA, and MAA in patients from 6 countries from the Panamerican League against Rheumatism myositis study group. We observed a general prevalence of 60% of ANA. In relation to MSA and MAA, anti-Mi-2 was the more frequent (38.5%).

Autoantibodies to Mi-2 alpha and Mi-2 beta in patients with idiopathic inflammatory myopathy.

OBJECTIVES: The objective of this study was to compare the results obtained from different assays for the detection of anti-Mi-2 antibodies, which are important markers in the diagnosis of DM. METHODS: The study included 82 patients (68 females/14 males), most of whom had DM (n = 57), followed by PM (n = 16) and juvenile DM (n = 9). All samples were tested using a novel particle-based multi-analyte technology (PMAT) (Inova Diagnostics, research use only) in parallel with a line immunoassay (LIA: Euroimmun). To assess clinical specificity for the PMAT assay, a total of 775 disease and healthy controls were tested. RESULTS: 29 samples were positive by at least one test for anti-Mi-2 antibodies. Of those, 24 were Mi-2ß LIA+, five were Mi-2α LIA+ and 23 Mi-2 PMAT+. The comparison shows varying agreement between the different methods (kappa 0.27-0.77). When LIA results were used as reference for receiver operating characteristics analysis, high area under the curve values were found for both PMAT vs LIA Mi-2α and LIA Mi-2ß. When analysing the results in the context of the myositis phenotype, PMAT associated closest with the DM phenotype. In the control group, 3/775 controls (all low levels) were anti-Mi-2+ resulting in a sensitivity and specificity of 28.1% and 99.6%, respectively. CONCLUSION: Overall, good agreement was found between LIA and PMAT for anti-Mi-2 antibodies, which is important for the standardization of autoantibodies. Anti-Mi-2ß antibodies measured by PMAT tend be more highly associated with the clinical phenotype of DM.

Termination of pregnancy in lupus nephritis: A bioethical analysis with the integrative method.

BACKGROUND AND OBJECTIVE: Termination of pregnancy in patients with rheumatic diseases is controversial and a bioethical analysis is rarely performed. In this study we analysed the case of a pregnant patient with lupus nephritis unresponsive to treatment, for whom termination of pregnancy is considered. METHODS: The integrative model was applied combining different normative ethical theories. RESULTS: From a utilitarian perspective, termination of pregnancy is justifiable, seeking the greatest benefit for the greatest number of stakeholders. Deontology justifies both terminating and continuing the pregnancy, focusing on the action itself and on autonomy. In virtue ethics the importance of decisions rests with the person who performs the action seeking flourishing; termination of pregnancy would be justifiable. DISCUSSION AND CONCLUSIONS: Interruption of pregnancy is a justifiable solution following the integrative model. Bioethical analysis of paradigmatic cases is essential to ensure the best possible action and as a precedent for future similar situations in rheumatology.

Update of the guidelines for the pharmacological treatment of rheumatoid arthritis by the Mexican College of Rheumatology 2023.

OBJECTIVE: To develop updated guidelines for the pharmacological management of rheumatoid arthritis (RA). METHODS: A group of experts representative of different geographical regions and various medical services catering to the Mexican population with RA was formed. Questions based on Population, Intervention, Comparison, and Outcome (PICO) were developed, deemed clinically relevant. These questions were answered based on the results of a recent systematic literature review (SLR), and the evidence's validity was assessed using the GRADE system, considered a standard for these purposes. Subsequently, the expert group reached consensus on the direction and strength of recommendations through a multi-stage voting process. RESULTS: The updated guidelines for RA treatment stratify various therapeutic options, including different classes of DMARDs (conventional, biologicals, and JAK inhibitors), as well as NSAIDs, glucocorticoids, and analgesics. By consensus, it establishes the use of these in different subpopulations of interest among RA patients and addresses aspects related to vaccination, COVID-19, surgery, pregnancy and lactation, and others. CONCLUSIONS: This update of the Mexican guidelines for the pharmacological treatment of RA provides reference points for evidence-based decision-making, recommending patient participation in joint decision-making to achieve the greatest benefit for our patients. It also establishes recommendations for managing a variety of relevant conditions affecting our patients.

Factors associated to COVID-19 vaccine acceptance in Mexican patients with rheumatic diseases: A cross-sectional and multicenter study.

COVID-19 vaccination is recommended in patients with rheumatic diseases (RDs) to prevent hospitalized COVID-19 and worse outcomes. However, patients' willingness to receive a SARS-CoV-2 vaccine and the associated factors vary across populations, vaccines, and time. The objective was to identify factors associated with COVID-19 vaccine acceptance (VA) in Mexican outpatients with RDs. This multicenter study was performed between March 1 and September 30, 2021, and four national centers contributed with patients. Participants filled out a questionnaire, which included 32 items related to patients' perception of the patient-doctor relationship, the COVID-19 vaccine component, the pandemic severity, the RD-related disability, comorbid conditions control, immunosuppressive treatment impact on the immune system, and moral/civil position of COVID-19 vaccine. Sociodemographic, disease-related, and treatment-related variables and previous influenza record vaccination were also obtained. Multiple logistic regression analyses identified factors associated with VA, which was defined based on a questionnaire validated in our population. There were 1439 patients whose data were analyzed, and the most frequent diagnoses were Rheumatoid Arthritis in 577 patients (40.1%) and Systemic Lupus Erythematosus in 427 (29.7%). Patients were primarily middle-aged women (1235 [85.8%]), with (mean±SD) 12.1 (±4.4) years of formal education. Years of education, corticosteroid use, patient perceptions about the vaccine and the pandemic severity, patient civil/moral position regarding COVID-19 vaccine, and previous influenza vaccination were associated with VA. In Mexican patients with RDs, COVID-19 VA is associated with individual social-demographic and disease-related factors, patient´s perceptions, and previous record vaccination. This information is crucial for tailoring effective vaccine messaging in Mexican patients with RDs.

[Guidelines in RA treatment: concepts on safety and recommendations using anti-TNF-alpha inhibitors. Grupo de Estudio de Nuevas Terapias de Enfermedades reumáticas (GENTE)]. / Recomendaciones para el tratamiento médico de la artritis reumatoide: actualización sobre la seguridad de los antagonistas del factor de necrosis tumoral alfa. Grupo de Estudio de Nuevas Terapias de Enfermedades reumáticas (GENTE).

Recommendations for the use of Disease-Modifying Antirheumatic Drugs (DMARD) with both conventional and biological agents in Rheumatoid Arthritis (RA) must be based on their safety profile, adverse effects, risks, and advantages. With the purpose of presenting the most updated information about the safety of tumor necrosis factor alpha (TNFalpha) antagonists, in this article we summarize the literature published during the last three years about this sort of biological agents in specific clinical situations, such as risk of developing infections, cancer, cardiovascular diseases, and autoimmunity; as well as their administration to patients who will undergo surgical procedures, pregnant and/or breast-feeding women, and patients who need immunizations. Likewise, in this analysis we offer specific recommendations, based on evidence, for the best anti-TNF-alfa management.

[Treatment guidelines for ankylosing spondylitis and its effect on Mexican rheumatology]. / Fundamentos para el tratamiento de la espondilitis anquilosante y su efecto en la reumatología mexicana.

We describe the guidelines for the current treatment of ankylosing spondylitis with an emphasis on the role and outlook of the Mexican rheumatologic community. The topics we analyze include: epidemiological as well as professional, financial, health status, and quality of life aspects. We propose to acknowledge that axial spondyloarthritis is the earliest form of ankylosing spondylitis. Finally we carry out a review of the literature supporting current therapeutic recommendations. Regarding the latter, we approached the ASAS/EULAR recommendations for the treatment of ankylosing spondylitis and their level of agreement with Mexican and other countries' rheumatologists. Finally, we analyzed the recommendations to start tumor necrosis alpha blockers among patients with ankylosing spondylitis.

The use of glucocorticoids by rheumatologic patients before attending a specialized department in México.

OBJECTIVE: To explore the extent and characteristics of glucocorticoid use by patients before attending a Mexican Rheumatology Department. MATERIAL AND METHODS: This is a cross-sectional study of 1000 consecutive first-time adults admitted to the outpatient clinic in a period of 6 months. Data were collected through a self-administered questionnaire, physician interviews, and prescription notes. RESULTS: Four hundred and sixty-one (58%) of 800 questionnaires analyzed reported glucocorticoid use: 73% of them were continuous users; 63% received long and 36% medium biologic half life compounds; and each patient received a median of 2 glucocorticoids (range, 1-42). The median daily, maximum, and cumulated doses--equivalent to prednisone--were 5 mg (0.7-70 mg), 6 mg (1.1-1250 mg), and 513 mg (5-151,209 mg); 46% of the patients received oral and 22% intramuscular compounds. General physicians and nonrheumatologist specialists produced 55% and 20% of the initial prescriptions. Although, the percentage of glucocorticoid users was higher among patients with inflammatory conditions (odds ratio 4.2, 95% confidence intervals 3.06-5.85), up to 44% of patients with noninflammatory diseases also received glucocorticoids. Ninety-one (20%) patients had gross adverse events. CONCLUSIONS: Before their first visit to a specialized department, nearly two-thirds of rheumatologic patients had taken glucocorticoids, which in most cases resulted from inappropriate prescription or recommendations by general physicians, nonrheumatologist specialists, and lay people.

Detection of autoantibodies to DSF70/LEDGFp75 in Mexican Hispanics using multiple complementary assay platforms.

PURPOSE: Antinuclear autoantibodies (ANA) targeting the dense fine speckled antigen DFS70, also known as lens epithelium-derived growth factor p75 (LEDGF/p75), are attracting attention due to their low frequency in systemic rheumatic diseases but increased frequency in clinical laboratory referrals and healthy individuals (HI). These ANA specifically recognize the stress protein DFS70/LEDGFp75, implicated in cancer, HIV-AIDS, and inflammation. While their frequency has been investigated in various ethnic populations, there is little information on their frequency among Hispanics/Latinos. In this study, we determined the frequency of anti-DFS70/LEDGFp75 autoantibodies in Mexican Hispanics using multiple detection platforms. METHODS: The frequency of anti-DFS70/LEDGFp75 antibodies was determined in 171 individuals, including 71 dermatomyositis (DM) patients, 47 rheumatoid arthritis (RA) patients, 30 obesity (OB) patients, and 23 HI. Antibody detection was achieved using four complementary assay platforms: indirect immunofluorescence, Western blotting, ELISA, and chemiluminescent immunoassay. RESULTS: We detected relatively low frequencies of anti-DFS70/LEDGFp75 antibodies in patients with DM (1.4%), RA (4.3%), and OB (6.6%), and elevated frequency (17.4%) in HI. A strong concordance between the different antibody detection platforms was observed. CONCLUSIONS: The low frequency of anti-DFS70/LEDGFp75 antibodies in Mexican patients with rheumatic diseases, but relatively higher frequency in HI, is consistent with previous observations with non-Hispanic populations, suggesting that geographic differences or ethnicity do not influence the frequency of these autoantibodies. Our results also highlight the importance of confirmatory assays for the accurate detection of these autoantibodies. Future studies with larger cohorts of healthy Hispanics/Latinos are needed to confirm if their anti-DFS70/LEDGFp75 antibody frequencies are significantly higher than in non-Hispanics.

Enfermedad por inyección de rellenos sintéticos permanentes (EIRSP). Recomendaciones del grupo de expertos del Capítulo de Biomateriales de la FILACP / Disease caused by permanent synthetic fillers FILACP Biomaterials Committee expert group recomendations

La enfermedad por rellenos sintéticos permanentes (EIRSP) representa un verdadero problema de salud pública sobre todo en América Latina, afectando a millones de personas, predominantemente mujeres de mediana edad de estrato económico medio-bajo. Actualmente no existe una conducta terapéutica consensuada, razón que motivó al Comité de Biomateriales de la FILACP 2020-2022 a crear un grupo de 9 expertos quienes se plantearon los siguientes objetivos: 1.- Resaltar la importancia de la enfermedad, 2.- Clasificar sus estadios clínicos, 3.- Proponer un protocolo integral de diagnóstico y tratamiento, 4.- Proponer una estrategia terapéutica multidisciplinaria y 5.- Promover campañas de prevención.El relleno sintético más utilizado con fines estéticos ha sido la silicona inyectada en cara, glúteos, mamas, miembros inferiores, manos y genitales, con alto potencial de migración. Otras substancias son el metacrilato, aceites minerales, parafina y la combinación de ellas. Ninguno de estos productos es de grado médico ni biocompatible. Al ser inyectados van a producir diversas reacciones locales y sistémicas desencadenadas por reacción de hipersensibilidad tipo IV, conduciendo al desarrollo de una enfermedad autoinmune de tejido conectivo.Se propone una clasificación basada en 6 estadios clínicos o grados. 1: Sin signos ni síntomas. 2: Cambios de coloración. 3: Inflamación, induraciones, cambios de textura y dolor. 4: Extrusión del producto con o sin infección. 5: Migración. 6: Complicaciones locales o sistémicas graves.Se establecen las pautas diagnósticas basadas en la historia clínica, exámenes de laboratorio, inmunológicos y radiológicos. Para este último, la resonancia magnética es la técnica de elección y en algunos casos, con excepción de glúteos y mamas, el ultrasonido es de gran utilidad. (AU)

Disease caused by permanent synthetic fillers (EIRSP acronym in Spanish) represents a real public health problem, especially in Latin America, affecting millions of people, predominantly middle-aged women from a medium-low economic stratum. Currently, there is no consensual therapeutic behavior, the reason that motivated the FILACP Biomaterials Committee 2020-2022 to create a group of 9 experts, who set the following objectives: 1.- Highlight the importance of the disease, 2.- Classify the clinical stages, 3.- Propose a comprehensive diagnosis and treatment protocol, 4.- Propose a multidisciplinary therapeutic strategy and 5.- Promote prevention campaigns.The most widely used synthetic filler for aesthetic purposes has been silicone injected into the face, buttocks, breasts, lower limbs, hands and genitals, with a high potential for migration. Other substances are methacrylate, mineral oils, paraffin, and a combination. None of these products have a medical grade or are biocompatible. When injected, they will produce various local and systemic reactions triggered by type IV hypersensitivity reactions, leading to the development of autoimmune connective tissue disease.A classification based on 6 clinical stages or grades is proposed. 1: No signs or symptoms. 2: Color changes. 3: Inflammation, indurations, texture changes, and pain. 4: Extrusion of the product with or without infection. 5: Migration. 6: Severe local or systemic complications.Diagnostic guidelines are established based on clinical history, laboratory, immunological and radiological tests. For the latter, magnetic resonance imaging is the technique of choice, and in some cases, except for the buttocks and breasts, ultrasound is beneficial. (AU)

Performance of an objective structured clinical examination in a national certification process of trainees in rheumatology.

OBJECTIVE: To assess reliability and validity of the objectively-structured clinical examination (OSCE) applied in postgraduate certification processes by the Mexican Board of Rheumatology. METHOD: Thirty-two (2013) and 38 (2014) Rheumatology trainees (RTs) underwent an OSCE consisting of 12 and 15 stations respectively, scored according to a validated check-list, as well as 300-multiple-choice 300 question examination (MCQ). Previously, 3 certified rheumatologists underwent a pilot-OSCE. A composite OSCE score was obtained for each participant and its performance examined. RESULTS: In 2013, OSCE mean score was 7.1±0.6 with none RT receiving a failing score while the MCQ score was 6.5±0.6 and 7 (21.9%) RTs receiving a failing (< 6) score. In 2014, the OSCE score was 6.7±0.6, with 3 (7.9%) RTs receiving a failing score (2 of them also failed MCQ) while the MCQ score was 6.4±0.5 and 7 (18.5%) RTs were disqualified (2 of them also failed OSCE). A significant correlation between the MCQ and the OSCE scores was observed in the 2013 (r=0.44; P=0.006). Certified rheumatologists performed better than RTs at both OSCE. Overall, 86% of RTs obtaining an OSCE passing score also obtained a MCQ passing score, while this was only 67% (P=.02) among those who obtained an OSCE failing score. Nine stations were applied at both consecutive years. Their performance was similar in both certification processes, with correlation coefficients ranging from 0.81 to 0.95 (P≤0.01). CONCLUSION: The OSCE is a valid and reliable tool to assess the Rheumatology clinical skills in RTs.

Interrupción del embarazo en nefritis lúpica: un análisis bioético desde el método integral / Termination of pregnancy in lupus nephritis: A bioethical analysis with the integrative method

Antecedentes y objetivo: La interrupción del embarazo en pacientes con enfermedades reumatológicas es controvertida y pocas veces se realiza un análisis bioético. En este estudio analizamos el caso de una paciente embarazada con nefritis lúpica sin respuesta a tratamiento a quien se le planteó la interrupción del embarazo. Métodos: Se aplicó el modelo integral, incluyendo distintos sistemas normativos para el análisis del dilema. Resultados: Desde el utilitarismo es justificable la interrupción del embarazo, buscando el mayor beneficio para la mayoría de las partes. La deontología justifica tanto continuar como interrumpir el embarazo, centrando la importancia en la acción misma y en la autonomía. Para la ética de la virtud, la importancia de las decisiones recae en la persona que realiza la acción buscando el florecimiento: la interrupción del embarazo sería justificable. Discusión y conclusiones: La interrupción del embarazo sería una solución adecuada según el modelo integral. El análisis bioético de casos paradigmáticos es fundamental para asegurar el mejor actuar posible en casos similares en reumatología.(AU)

Background and objective: Termination of pregnancy in patients with rheumatic diseases is controversial and a bioethical analysis is rarely performed. In this study we analysed the case of a pregnant patient with lupus nephritis unresponsive to treatment, for whom termination of pregnancy is considered. Methods: The integrative model was applied combining different normative ethical theories. Results: From a utilitarian perspective, termination of pregnancy is justifiable, seeking the greatest benefit for the greatest number of stakeholders. Deontology justifies both terminating and continuing the pregnancy, focusing on the action itself and on autonomy. In virtue ethics the importance of decisions rests with the person who performs the action seeking flourishing; termination of pregnancy would be justifiable. Discussion and conclusions: Interruption of pregnancy is a justifiable solution following the integrative model. Bioethical analysis of paradigmatic cases is essential to ensure the best possible action and as a precedent for future similar situations in rheumatology.(AU)

Hand function in rheumatic diseases: patient and physician evaluations.

AIM: Rheumatic diseases have repercussions in hand function. The m-SACRAH (modified Score for the Assessment and quantification of Chronic Rheumatoid Affections of the Hands) questionnaire evaluates hand function according to the patient's opinion. Our aim was to look for the clinical and para-clinical variables that correlate with m-SACRAH in rheumatic diseases. METHODS: Consecutive patients with diagnoses of rheumatoid arthritis (RA), osteoarthritis (OA), gout, and systemic sclerosis (SS) with hand involvement and who agreed to participate, answered the m-SACRAH and Health Assessment Questionnaire Disability Index (HAQ-DI) and underwent blinded and independent rheumatologist and physiatrist evaluations. Nerve conduction studies (NCS) and hand ultrasonography (USG) were performed. STATISTICAL ANALYSIS: Spearman's correlation and the Mann-Whitney U-test. RESULTS: Forty patients were included. There were 72% women and mean age of 49.25 ± 14.2 years. According to m-SACRAH patients were dived into two groups (mild vs. moderate-severe), only the number limited to motion joints were different among them (median 2 vs. 8 P = 0.036). Patients' perspective variables had a good correlation (HAQ-DI/mSACRAH: r = 0.43, P < 0.05), but only correlated with limited motion joints (r = 0.41, P < 0.05 for m-SACRAH and r = 0.31, P < 0.05 for HAQ-DI). Physician's evaluations had a good correlation. Visual analog scale of hand function with physiatrist evaluations: passive range of motion (r = -0.49, P = 0.001), sum of affected pinches (r = 0.66, P = 0.001), limited to motion joints (r = 0.34, P < 0.05) and palm-finger distance (r = 0.50, P = 0.05). Regarding para-clinical evaluations, only tenosynovitis by ultrasonography correlated with HAQ-Di (r = 0.357, P < 0.05). CONCLUSIONS: Patients' perspectives correlated with the number of limited motion joints but with none of the other physicians' and para-clinical evaluations. The patients' opinion about their function should play a major role in their management.

Update of the Mexican College of Rheumatology guidelines for the pharmacologic treatment of rheumatoid arthritis.

BACKGROUND: The pharmacologic management of rheumatoid arthritis has progressed substantially over the past years. It is therefore desirable that existing information be periodically updated. There are several published international guidelines for the treatment of rheumatoid arthritis that hardly adapt to the Mexican health system because of its limited healthcare resources. Hence, it is imperative to unify the existing recommendations and to incorporate them to a set of clinical, updated recommendations; the Mexican College of Rheumatology developed these recommendations in order to offer an integral management approach of rheumatoid arthritis according to the resources of the Mexican health system. OBJECTIVE: To review, update and improve the available evidence within clinical practice guidelines on the pharmacological management of rheumatoid arthritis and produce a set of recommendations adapted to the Mexican health system, according to evidence available through December 2012. METHODS: The working group was composed of 30 trained and experienced rheumatologists with a high quality of clinical knowledge and judgment. Recommendations were based on the highest quality evidence from the previously established treatment guidelines, meta-analysis and controlled clinical trials for the adult population with rheumatoid arthritis. RESULTS: During the conformation of this document, each working group settled the existing evidence from the different topics according to their experience. Finally, all the evidence and decisions were unified into a single document, treatment algorithm and drug standardization tables. CONCLUSIONS: This update of the Mexican Guidelines for the Pharmacologic Treatment of Rheumatoid Arthritis provides the highest quality information available at the time the working group undertook this review and contextualizes its use for the complex Mexican health system.

Biosimilar drugs in Mexico: position of the Mexican College of Rheumatology, 2012.

Biotechnological drugs (BTDs) are complex molecules whose manufacturing process precludes the ability to identically reproduce the structure of the original product, and therefore there cannot be an absolute equivalence between the original (innovative) medication and its biosimilar counterpart. BTDs have been proven useful in the treatment of several rheumatic diseases, however their high cost has prevented their use in many patients. Several BTD patents have expired or are close to expire, triggering the development of structurally similar drugs with efficacy and safety profiles comparable to the innovative compound; however, these must be evaluated through evidence based medicine. The Mexican General Health Law contemplates the registry of these biosimilar drugs for their use in our country. This document is a forethought from members of the Mexican College of Rheumatology, pharmacologists, and epidemiologists, in accordance with Mexican health authorities regarding the necessary scientific evidence required to evaluate the efficacy and safety of biosimilar drugs before and after their arrival to the Mexican market.

Evaluation of hand function in rheumatic disease. Validation and usefulness of the Spanish version AUSCAN, m-SACRAH and Cochin questionnaires.

INTRODUCTION: Questionnaires to evaluate hand function are variable in the number of items, domains and diseases in which they had been previously used. OBJECTIVES: a) To translate to Spanish and validate the m-SACRAH and AUSCAN questionnaires; b) to do a transcultural adaptation of DASHe, previously validated in Spain), and c) to compare them and the Cochin questionnaire (previously validated in México), in rheumatic patients with variable impairment of hand function. MATERIAL AND METHODS: m-SACRAH, AUSCAN and DASH were translated/retro-translated and adapted. The final version was revised to determine content validity and them, plus Cochin were applied to 10 healthy subjects (pilot study) with a variable educational level and in 16 rheumatic patients with variable diagnoses and degrees of hand function impairment; all patients answered 4 questionnaires and were evaluated clinically by blinded investigators. RESULTS: Seventy six percent were women, mean age 45.7±11.4 years. Cronbach́s alpha >0.90; time to answer went from 2.3±0.087 (AUSCAN) to 3.5±0.36 minutes (DASH). There was good correlation among them (r=0.0683 AUSCAN-m-SACRAH to r=0.889 AUSCAN-DASH) and good capability for discrimination between patients with mild VS moderate to severe impairment was also demonstrated; patients with mild impairment needed less time to answer them and there were no significant differences among questionnaire scores. Patients prefered AUSCAN (10/16), Cochin (4/16) and m-SACRAH (2/16). CONCLUSION: The 4 questionnaires are useful to evaluate hand function in rheumatic patients and have good discrimination capability. More patients preferred AUSCAN.

Desempeño del examen clínico objetivo estructurado como instrumento de evaluación en la certificación nacional como reumatólogo / Performance of an objective structured clinical examination in a national certification process of trainees in rheumatology

Objetivo. Determinar la validez de constructo y la confiabilidad de un examen clínico objetivo estructurado (ECOE) en la evaluación de una certificación nacional como reumatólogo. Método. En 2013 y 2014, se aplicaron sendos ECOE y evaluación teórica (ET) a 32 y 38 residentes aspirantes a la certificación de reumatólogo, respectivamente. Se incluyeron 12 y 15 estaciones calificadas mediante lista de cotejo validada. Previamente, 3 reumatólogos certificados realizaron sendas pruebas piloto. Se calculó la puntuación global del ECOE y se evaluó su desempeño. Resultados. En 2013, la media ± DE del ECOE fue de 7,1 ± 0,6) y ningún aspirante tuvo calificación reprobatoria (CR); la media de la ET fue de 6,5 ± 0,6 y 7 aspirantes (21,9%) tuvieron CR (< 6). En 2014, la media del ECOE fue de 6,7 ± 0,6) y 3 aspirantes (7,9%) tuvieron CR, de los cuales 2 reprobaron la ET; la media de la ET fue de 6,4 ± 0,5) y 7 aspirantes (18,5%) tuvieron CR, 2 de los cuales reprobaron el ECOE. En 2013, la correlación entre el ECOE y la ET fue de r = 0,44, p = 0,006. En ambos años, los reumatólogos certificados obtuvieron mejores calificaciones en el ECOE que los residentes. El porcentaje de aprobados en la ET fue mayor entre quienes aprobaron el ECOE que entre quienes lo reprobaron: 86% vs. 67%, p = 0,02. Se aplicaron 9 estaciones en ambos años y sus puntuaciones mostraron correlación de 0,81 a 0,95, p ≤ 0,01. Conclusión. El ECOE es una herramienta adecuada para evaluar las competencias clínicas de los aspirantes a la certificación (AU)

Objective. To assess reliability and validity of the objectively-structured clinical examination (OSCE) applied in postgraduate certification processes by the Mexican Board of Rheumatology. Method. Thirty-two (2013) and 38 (2014) Rheumatology trainees (RTs) underwent an OSCE consisting of 12 and 15 stations respectively, scored according to a validated check-list, as well as 300-multiple-choice 300 question examination (MCQ). Previously, 3 certified rheumatologists underwent a pilot-OSCE. A composite OSCE score was obtained for each participant and its performance examined. Results. In 2013, OSCE mean score was 7.1 ± 0.6 with none RT receiving a failing score while the MCQ score was 6.5 ± 0.6 and 7 (21.9%) RTs receiving a failing (< 6) score. In 2014, the OSCE score was 6.7 ± 0.6, with 3 (7.9%) RTs receiving a failing score (2 of them also failed MCQ) while the MCQ score was 6.4 ± 0.5 and 7 (18.5%) RTs were disqualified (2 of them also failed OSCE). A significant correlation between the MCQ and the OSCE scores was observed in the 2013 (r=0.44; P=0.006). Certified rheumatologists performed better than RTs at both OSCE. Overall, 86% of RTs obtaining an OSCE passing score also obtained a MCQ passing score, while this was only 67% (P=.02) among those who obtained an OSCE failing score. Nine stations were applied at both consecutive years. Their performance was similar in both certification processes, with correlation coefficients ranging from 0.81 to 0.95 (P≤0.01). Conclusion. The OSCE is a valid and reliable tool to assess the Rheumatology clinical skills in RTs (AU)