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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.
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Antirreumáticos , Artrite Reumatoide , Artrite Reumatoide/tratamento farmacológico , Humanos , México , Antirreumáticos/uso terapêutico , Glucocorticoides/uso terapêutico , Feminino , Anti-Inflamatórios não Esteroides/uso terapêutico , Gravidez , Analgésicos/uso terapêuticoRESUMO
Desarrollar guías actualizadas para el manejo farmacológico de la artritis reumatoide (AR). Se conformó un grupo de expertos que fueran representativos de las distintas regiones geográficas y los diferentes servicios médicos que atienden a la población mexicana con AR. Se desarrollaron preguntas basadas en Población, Intervención, Comparación y Desenlace [Outcome] (PICO) que fueron consideradas relevantes desde el punto de vista clínico; las preguntas encontraron su respuesta en los resultados de una revisión sistemática de la literatura (RSL) reciente y la validez de la evidencia fue evaluada mediante el sistema GRADE, considerado un estándar para estos fines. Posteriormente, el grupo de expertos desarrollaró un acuerdo en la dirección y fuerza de las recomendaciones mediante un proceso de votación en distintas etapas. Las guías actualizadas para el tratamiento de la AR categorizan en forma estratificada a las distintas opciones terapéuticas incluyendo las distintas familias de fármacos modificadores de la enfermedad (FARME): convencionales, biológicos e inhibidores de JAK), además de AINE, glucocorticoides y analgésicos. Establece por consenso el uso de todos ellos en distintas subpoblaciones de interés de pacientes con AR, y aborda, además, aspectos relacionados con la vacunación, la COVID-19, la cirugía, el embarazo y la lactancia entre otros. La presente actualización de las guías mexicanas para el tratamiento farmacológico de la AR brinda elementos de referencia en la toma de decisiones basados en la evidencia científica más reciente, y recomienda la participación del paciente para la toma de decisiones conjuntas en la búsqueda del mayor beneficio de nuestros pacientes; establece además, recomendaciones para el manejo de una diversidad de condiciones relevantes que afectan a nuestros pacientes.
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Humanos , Artrite Reumatoide/tratamento farmacológico , Terapia Biológica , Antirreumáticos/uso terapêutico , MéxicoRESUMO
INTRODUCTION: COVID-19 was declared a pandemic in March 2020, requiring a comprehensive response from all healthcare systems, including Mexico's. As medical residents' training did not involve epidemic response, we decided to evaluate their level of training on this subject, specifically self-perceived knowledge level and capacity to respond to epidemiological crises. METHODOLOGY: Medical residents from two hospitals belonging to PEMEX (Mexico's state-owned petroleum company) were included in a cross-sectional study. All participants answered a modified version of the survey developed by the University of Lovaina's Center for Research and Education in Emergency Care. Participants were analyzed according to their relevant "clinical" or "surgical" residency tracks. Data were analyzed using through Chi-square tests, t-tests, Mann-Whitney U tests, Kruskal-Wallis tests, and Pearson and Spearman correlation coefficients with significance established at p < 0.05. RESULTS: Of a total of 94 resident participants in this study, 56.7% self-perceived themselves as being poorly prepared to confront the pandemic. Only 25.5% of the participants referred previous experience in medical responses to public health emergencies, and only 35.1% reported ever receiving education on this topic. CONCLUSIONS: Medical residents-who have been involved with caring for victims of the pandemic-are under the general perception that they are not prepared, experienced, or educated enough to respond to such a widespread massive public health emergency.
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COVID-19/epidemiologia , Competência Clínica , Internato e Residência , SARS-CoV-2 , Autoimagem , Estudantes de Medicina/psicologia , Adulto , Estudos Transversais , Feminino , Humanos , Masculino , Corpo Clínico Hospitalar , México/epidemiologia , Pandemias , Inquéritos e QuestionáriosRESUMO
OBJECTIVE: To determine the comorbidities associated with disability in patients with OA in Mexico (2013-2015). MATERIAL AND METHODS: A cross-sectional, retrospective and multicentre IMPACTAR study (n=7703) in Mexican patients (2013-2015). Comorbidities associated with disability were identified in 4971 patients diagnosed with OA from the IMPACTAR registry (n=7073). An adjusted logistic regression analysis was carried out by demographic, economic, clinical and medical variables. RESULTS: Mean age was 63 years; and 75% of the patients were women. Subjects with OA and presence of comorbidities are 42% more likely to develop disabilities than patients without associated comorbidity, considering age, sex, family income, OA diagnosis duration, and education level. The highest rate of people with disability (28.9%) was concentrated in Region 7, which corresponds to Mexico City. There are also significant differences between median family incomes, when the income of persons with disability is under $13 000 (IQR: 9000-16 000) Mexican pesos, compared to patients without disability. Almost half of the subjects (49.6%) reported having at least one comorbidity. Arterial hypertension was the risk factor with a statistically significant difference (32.8%) among those with disability (34.7%). CONCLUSIONS: Programs and interventions for OA patients should take into consideration comorbidity factors, being female, family income, and the region of residence as variables that may increase the possibility of developing an OA-associated disability.
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Pessoas com Deficiência , Osteoartrite , Comorbidade , Estudos Transversais , Feminino , Humanos , México/epidemiologia , Pessoa de Meia-Idade , Osteoartrite/epidemiologia , Sistema de Registros , Estudos RetrospectivosRESUMO
In response to the kind letter from Joaquín Cabezas et al., we agree that medical care in the COVID era has radically changed and using new mechanisms in the care of different diseases is undoubtedly now a priority to avoid contagion of both the patient and the medical staff. Although a vaccine could protect the population, there are still many questions to answer. The model we use for the care of patients with a diagnosis of hepatitis C virus (HCV) in Mexico showed great benefits, as in other studies.
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COVID-19 , Hepatite C Crônica , Hepatite C , Telemedicina , Antivirais/uso terapêutico , Hepacivirus , Hepatite C/tratamento farmacológico , Hepatite C Crônica/tratamento farmacológico , Humanos , México , SARS-CoV-2RESUMO
Resumen Existe la percepción general de que los estudiantes de medicina deben ayudar en caso de situaciones de desastre o en contingencias epidemiológicas; aunque es posible que no hayan sido debidamente educados para hacerlo. En últimas fechas, la participación de estudiantes es importante en actividades de capacitación de personal, triage, atención de actividades burocráticas, voluntariado; pero no son considerados como una primera línea de atención en los sitios de desastre o de manejo de pacientes. Se revisa en la literatura médica la percepción de la participación de los estudiantes de medicina en desastres y pandemias y se establecen algunas de las necesidades para su capacitación y enseñanza, para que realmente puedan convertirse en una opción en los momentos de crisis.
Abstract There is a general perception that medical students should help in case of disaster situations or epidemiological contingencies; although, they may not have been properly educated to do so. In recent dates, the participation of students is important in staff training activities, triage, care of bureaucratic activities, volunteering; but they are not considered a first line of care at disaster sites or patient management. The perception of the participation of medical students in disasters and pandemics is reviewed in the literature and some of the needs for their training and teaching are established, so that they can truly become an option in times of crisis.
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Humanos , Estudantes de Medicina , Desastres , Triagem , PandemiasRESUMO
OBJECTIVE: To determine the comorbidities associated with disability in patients with OA in Mexico (2013-2015). MATERIAL AND METHODS: A cross-sectional, retrospective and multicentre IMPACTAR study (n=7703) in Mexican patients (2013-2015). Comorbidities associated with disability were identified in 4971 patients diagnosed with OA from the IMPACTAR registry (n=7073). An adjusted logistic regression analysis was carried out by demographic, economic, clinical and medical variables. RESULTS: Mean age was 63 years; and 75% of the patients were women. Subjects with OA and presence of comorbidities are 42% more likely to develop disabilities than patients without associated comorbidity, considering age, sex, family income, OA diagnosis duration, and education level. The highest rate of people with disability (28.9%) was concentrated in Region 7, which corresponds to Mexico City. There are also significant differences between median family incomes, when the income of persons with disability is under $13 000 (IQR: 9000-16 000) Mexican pesos, compared to patients without disability. Almost half of the subjects (49.6%) reported having at least one comorbidity. Arterial hypertension was the risk factor with a statistically significant difference (32.8%) among those with disability (34.7%). CONCLUSIONS: Programs and interventions for OA patients should take into consideration comorbidity factors, being female, family income, and the region of residence as variables that may increase the possibility of developing an OA-associated disability.
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There is a general perception that medical students should help in case of disaster situations or epidemiological contingencies; although, they may not have been properly educated to do so. In recent dates, the participation of students is important in staff training activities, triage, care of bureaucratic activities, volunteering; but they are not considered a first line of care at disaster sites or patient management. The perception of the participation of medical students in disasters and pandemics is reviewed in the literature and some of the needs for their training and teaching are established, so that they can truly become an option in times of crisis.
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Desastres , Estudantes de Medicina , Humanos , Pandemias , TriagemRESUMO
INTRODUCTION: Rheumatologists are the primary healthcare professionals responsible for patients with rheumatic diseases and should acquire medical ethical competencies, such as the informed consent process (ICP). The objective clinical structured examination is a valuable tool for assessing clinical competencies. We report the performance of 90 rheumatologist trainees participating in a station designed to evaluate the ICP during the 2018 and 2019 national accreditations. METHODS: The station was validated and represented a medical encounter in which the rheumatologist informed a patient with systemic lupus erythematosus with clinically active nephritis about renal biopsy. A trained patient-actor and an evaluator were instructed to assess ICP skills (with a focus on kidney biopsy benefits, how the biopsy is done and potential complications) in obtaining formal informed consent, delivering bad news and overall communication with patients. The evaluator used a tailored checklist and form. RESULTS: Candidate performance varied with ICP content and was superior for potential benefit information (achieved by 98.9% of the candidates) but significantly reduced for potential complications (37.8%) and biopsy description (42.2%). Only 17.8% of the candidates mentioned the legal perspective of ICP. Death (as a potential complication) was omitted by the majority of the candidates (93.3%); after the patient-actor challenged candidates, only 57.1% of them gave a clear and positive answer. Evaluators frequently rated candidate communications skills as superior (≥80%), but ≥1 negative aspect was identified in 69% of the candidates. CONCLUSIONS: Ethical competencies are mandatory for professional rheumatologists. It seems necessary to include an ethics competency framework in the curriculum throughout the rheumatology residency.
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Acreditação , Competência Clínica , Ética Médica , Reumatologia/ética , Acreditação/métodos , Acreditação/normas , Biópsia/ética , Competência Clínica/normas , Humanos , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/normas , Rim/patologia , Lúpus Eritematoso Sistêmico/diagnóstico , Lúpus Eritematoso Sistêmico/patologia , México , Relações Médico-Paciente/ética , Reumatologia/normasRESUMO
Resumen: OBJETIVO: Evaluar la dosis acumulada ingerida de antiinflamatorios no esteroides (AINEs) en pacientes con úlcera péptica hemorrágica y sus complicaciones durante la hospitalización. MATERIAL Y MÉTODO: Estudio retrospectivo en el que de julio de 2015 a diciembre de 2017 se evaluaron dos grupos: uno con antecedente hospitalario de perforación, resangrado, reintervención endoscópica y muerte y otro sin complicaciones. Se ajustó la dosis ingerida de diferentes AINEs equivalente a 10 mg de ketorolaco; se registró el índice de Charlson, infección por H. pylori y la clasificación endoscópica de Forrest. RESULTADOS: Hubo 156 admisiones de úlcera péptica hemorrágica (edad promedio de 70 años, 53% hombres), las complicaciones ocurrieron en 53 (33.9%), la dosis promedio mensual de AINEs fue de 2121 mg (pacientes con complicaciones) vs 1970 mg (sin complicaciones; p = 0.2). La tasa de AINEs/semana de 7.1 se relacionó con perforación. A todos se les aplicó dosis de omeprazol de 40 mg cada 12 horas vía intravenosa durante la hospitalización. Las complicaciones se correlacionaron con mayor índice de Charlson. Hubo relación entre muerte, factores de riesgo de úlcera péptica por estrés (sepsis, traumatismo, etc.) y la administración de anticoagulantes. El tabaquismo y el género masculino se relacionaron con mayor resangrado. CONCLUSIONES: Existe mayor probabilidad de perforación con necesidad de cirugía, estancia hospitalaria más larga y mayor número de transfusiones con mayor dosis ingerida de AINEs.
Abstract: OBJECTIVE: To evaluate the cumulative dose of nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with hemorrhagic peptic ulcer and their complications along hospitalization. MATERIAL AND METHOD: A retrospective study done from July 2015 to December 2017 including two groups: one with a hospitalization history of perforation, rebleeding, endoscopic reintervention and death, another group without complications. We registered doses of different NSAIDs according to 10 mg of ketorolac, Charlson index, H. pylori infection and endoscopic Forrest classification. RESULTS: There were 156 admissions of hemorrhagic peptic ulcer with the administration of NSAIDs (average age 70 years, 53% men), complications occurred in 53 (33.9%). The average monthly dose of NSAID in the cases was 2121 mg vs 1970 mg in controls. The NSAID/week rate of 7.1 was associated with perforation. Charlson index correlated with complications. Death and physiological stress related with the administration of anticoagulants. Smoking and the male gender related to higher rebleeding. CONCLUSIONS: The higher the NSAID/weekly rate, the higher the probability of perforation with the need for surgery, longer hospital stay and increased number of transfusions.
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INTRODUCTION: Pain is a core complaint among rheumatoid arthritis (RA) patients, and persistent pain requires treatment adjustments according to current strategies. We aimed to quantify the impact of hand osteoarthritis (OA) on health status and residual pain in patients with RA. METHODS: This cross-sectional survey compared RA patients with and without osteoarthritis of the hand. The main outcome was pain intensity. Other measurements included disease activity scores (the Disease Activity Score 28-joints; the Simplified Disease Activity Index, SDAI; the Clinical Disease Activity Index, CDAI), functional disability and self-reported quality of life, and the proportion of patients with residual pain (Patient Acceptable Symptom State, PASS). RESULTS: Eighty-one patients were analyzed, including 39 with RA and OA and 42 with RA only. The patients were mainly women (94%), with a median disease duration of 13 years. This group also reported a higher intensity of pain (visual analogue scale, VAS 70 mm vs. 30 mm; p = 0.003), higher disease activity (3.89 vs. 2.88; p = 0.001), and greater functional disability irrespective of treatment and comorbidities. A strong correlation (r2 = 0.69; p < 0.001) between pain and disease activity was observed, although no differences in pain were observed between groups according to disease activity categories. Patients with RA and OA had a higher proportion of residual pain (59% vs. 29%; p = 0.006) even in the absence of clinical inflammation. CONCLUSION: The coexistence of RA and hand OA is associated with distorted disease activity measurements in RA. Osteoarthritis contributes to persistent pain and greater disability in patients with RA.
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Artrite Reumatoide/complicações , Artrite Reumatoide/fisiopatologia , Mãos/fisiopatologia , Osteoartrite/complicações , Osteoartrite/fisiopatologia , Atividades Cotidianas , Idoso , Estudos Transversais , Feminino , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Dor/fisiopatologia , Manejo da Dor , Medição da Dor , Qualidade de Vida , Autorrelato , Índice de Gravidade de Doença , Inquéritos e Questionários , Escala Visual AnalógicaRESUMO
BACKGROUND: The Mexican Accreditation Council for Rheumatology annually certifies trainees in Rheumatology using a multiple-choice test and an objective structured clinical examination (OSCE). Since 2015, candidate's communication skills (CS) have been rated by both patients and by physician examiners and correlated with results on the OSCE. This study compared the CS from candidates to annual accreditation in Rheumatology as rated by patients and by physician examiners, and assessed whether these correlated with candidate's performance in the OSCE. MATERIAL AND METHODS: From 2015 to 2017, 8areas of CS were evaluated using a Likert scale, in each OSCE station that involved a patient. Both patient and physician evaluators were trained annually and their evaluations were performed blindly. The associations were calculated using the Pearson correlation coefficient. RESULTS: In general, candidates were given high CS scores; the scores from patients of the candidate's CS were better than those of physician examiners; within the majority of the stations, both scores were found to correlate moderately. In addition, the scoring of CS correlated with trainee performance at the corresponding OSCE station. Interestingly, better correlations were found when the skills were rated by the patients compared to physician scores. The average CS score was correlated with the overall OSCE performance for each trainee, but not with the multiple-choice test, except in the 2017 accreditation process, when a weak correlation was found. CONCLUSIONS: CS assessed during a national accreditation process correlated with the candidate's performance at the station level and with the overall OSCE.
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Certificação/normas , Competência Clínica/normas , Comunicação , Educação de Pós-Graduação em Medicina/normas , Reumatologia/educação , Humanos , México , Reumatologia/normasRESUMO
OBJECTIVE: To assess the efficacy and side effects of methotrexate and leflunomide in patients with rheumatoid arthritis (RA) as the first disease-modifying antirheumatic drug (DMARD). METHODS: We performed a systematic review and meta-analysis of clinical studies that included patients who took methotrexate, leflunomide, placebo or another DMARD for RA treatment. A systematic review yielded 1971 articles from databases; once completely reviewed, 73 trials that completed inclusion criteria were selected. In structured workshops for discussion and assessment of each article, 6 could be meta-analyzed for the primary and secondary outcomes: achievement of American College of Rheumatology (ACR) 20 and its core set components; and change of serum C-reactive protein (CRP) levels, Health Assessment Questionnaire Disability Index (HAQ-Di), liver enzyme aspartate transaminase/alanine transaminase ratio, new gastrointestinal (GI) side effects and infections. RESULTS: A total of 1984 patients were included: 986 took leflunomide and 998 methotrexate. The probability of achieving ACR 20 had an odds ratio (OR) of 0.88 (95% confidence interval [CI] 0.74, 1.06) with a trend toward favoring methotrexate; reduction of the swollen joint count was greater for methotrexate: mean difference=0.82 (95%CI 0.24, 1.39); tender joint count, physician global assessment, HAQ-Di, and serum CRP levels revealed no significant difference between groups. Increased liver enzymes were more frequent in the leflunomide group, OR=0.38 (95%CI 0.27, 0.53), and new GI complaints were more common with methotrexate (OR=1.44; 95%CI 1.17, 1.79). There was no difference in the incidence of non-severe infections. CONCLUSION: Leflunomide used as the first DMARD in RA seemed to be as efficacious as methotrexate; only the reduction of swollen joint count was more marked for methotrexate. Leflunomide was linked to a greater increase in liver enzymes, but there were fewer GI complaints.
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Anti-Inflamatórios não Esteroides/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Imunossupressores/uso terapêutico , Leflunomida/uso terapêutico , Metotrexato/uso terapêutico , Alanina Transaminase/sangue , Anti-Inflamatórios não Esteroides/efeitos adversos , Antirreumáticos/efeitos adversos , Aspartato Aminotransferases/sangue , Proteína C-Reativa/análise , Doença Hepática Induzida por Substâncias e Drogas/etiologia , Ensaios Clínicos como Assunto , Avaliação da Deficiência , Quimioterapia Combinada , Gastroenteropatias/induzido quimicamente , Humanos , Imunossupressores/efeitos adversos , Leflunomida/efeitos adversos , Metotrexato/efeitos adversos , Resultado do Tratamento , gama-Glutamiltransferase/análiseRESUMO
Resumen La osteoartritis es una enfermedad articular crónica degenerativa, es la afección articular observada con más frecuencia en la población adulta y una de las principales causas de discapacidad en todo el mundo, por lo que es de importancia el diagnóstico y tratamiento en las fases tempranas de la enfermedad. En la actualidad los nuevos tratamientos, además de aliviar el dolor, pueden disminuir la limitación funcional y modificar el curso de la enfermedad. El objetivo de este artículo es actualizar la evidencia acerca del diagnóstico y de las nuevas formas de tratamiento de la osteoartritis, así como evaluar los cambios en la evidencia que ha habido en relación con la guía anterior. Para la elaboración de la guía motivo de esta reunión, se contó con la participación de especialistas en Medicina Interna, Reumatología, Ortopedia y Rehabilitación física, un bibliotecario y un experto en metodología; se realizó una búsqueda extensa en PubMed y en otros sitios web especializados. Se estableció una serie de recomendaciones y niveles de evidencia basados en la bibliografía consultada. Se concluye que la osteoartritis es una enfermead compleja que implica múltiples factores de riesgo, por lo que es importante tomar en cuenta que el tratamiento es multidisciplinario y consta de un enfoque no farmacológico y uno farmacológico; sin embargo, es necesario crear una cultura preventiva de la osteoartritis en los médicos tratantes, en la que se eduque y se dé información al paciente para evitar que la enfermedad progrese.
Abstract Osteoarthritis, a chronic degenerative joint disease, is the joint condition most frequently observed in the adult population; is one of the leading causes of disability worldwide. Therefore, it is important the diagnosis and treatment in the early stages of the disease. Currently new therapies, in addition to relieving pain, can reduce functional limitation and modify the course of the disease. The objective of this article is to update the evidence on diagnosis and new forms of osteoarthritis treatment, as well as to evaluate the changes in the evidence that has been in relation to the previous guide. For the elaboration of the guide, there was participation of specialists (Internal Medicine, Rheumatology, Orthopedics and Physical Rehabilitation), a librarian and an expert in methodology; an extensive search was carried out in PubMed and other specialized websites. A series of recommendations and levels of evidence were established based on the bibliography consulted. Concluding that osteoarthritis is a complex pathology involving multiple risk factors, it is important to consider that the treatment is multidisciplinary and consists of a non-pharmacological approach and a pharmacological treatment; however, it is necessary to create a preventive culture on osteoarthritis in treating doctors, in which the patient is educated and given information to prevent the disease from progressing.
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BACKGROUND: The Mexican Accreditation Council for Rheumatology certifies trainees (TR) on an annual basis using both a multiple-choice question (MCQ) test and an objective structured clinical examination (OSCE). For 2013 and 2014, the OSCE pass mark (PM) was set by criterion referencing as ≥6 (CPM), whereas overall rating of borderline performance method (BPM) was added for 2015 and 2016 accreditations. We compared OSCE TR performance according to CPM and BPM, and examined whether correlations between MCQ and OSCE were affected by PM. METHODS: Forty-three (2015) and 37 (2016) candidates underwent both tests. Altogether, OSCE were integrated by 15 validated stations; one evaluator per station scored TR performance according to a station-tailored check-list and a Likert scale (fail, borderline, above range) of overall performance. A composite OSCE score was derived for each candidate. Appropriate statistics were used. RESULTS: Mean (±standard derivation [SD]) MCQ test scores were 6.6±0.6 (2015) and 6.4±0.6 (2016) with 5 candidates receiving a failing score each year. Mean (±SD) OSCE scores were 7.4±0.6 (2015) and 7.3±0.6 (2016); no candidate received a failing CPM score in either 2015 or 2016 OSCE, although 21 (49%) and 19 (51%) TR, respectively, received a failing BPM score (calculated as 7.3 and 7.4, respectively). Stations for BPM ranged from 4.5 to 9.5; overall, candidates showed better performance in CPM. In all, MCQ correlated with composite OSCE, r=0.67 (2015) and r=0.53 (2016); P≤.001. Trainees with a passing BPM score in OSCE had higher MCQ scores than those with a failing score. CONCLUSIONS: Overall, OSCE-PM selection impacted candidates' performance but had a limited affect on correlation between clinical and practical examinations.
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Desempenho Acadêmico/normas , Certificação/normas , Competência Clínica/normas , Educação de Pós-Graduação em Medicina/normas , Avaliação Educacional/normas , Reumatologistas/educação , Avaliação Educacional/métodos , Humanos , México , Reumatologia/educaçãoRESUMO
BACKGROUND: It is unknown which analgesic modality gives better results after a laparoscopic cholecystectomy. The aim of this study was to compare the analgesic efficacy of ropivacaine for local use against that of intravenous dipyrone in laparoscopic cholecystectomy. METHODS: A non-inferiority randomized clinical trial. Fifty patients with laparoscopic cholecystectomy were included into two separate groups. INTERVENTION: 0.75 % ropivacaine infiltrated at the trocar insertion sites and in the gallbladder fossa compared with intravenous dipyrone. MEASUREMENTS: The primary outcome was pain, which was assessed using the visual analog scale during the first 24 hours. Secondary outcomes were the presence of adverse effects, and the need for analgesic rescue with tramadol. RESULTS: The visual analog scale average for pain at the conclusion of the surgery was 3.8 in the ropivacaine vs. 3.56 in the dipyrone groups, while at 6, 12 and 24 hours the values were 2.64, 1.92 and 1.28, respectively, for ropivacaine versus 2.6, 1.88 and 1.2, respectively, for dipyrone. No adverse effects were observed in either group, and the two groups exhibited similar needs for analgesic rescue with tramadol. CONCLUSIONS: Infiltration of 0.75 % ropivacaine at the trocar insertion sites and the gallbladder exhibits analgesia similar to IV dipyrone during the first 24 hours post-laparoscopic cholecystectomy without adverse effects.
Introducción: se desconoce qué modalidad analgésica brinda mejores resultados después de una colecistectomía laparoscópica. El objetivo de este estudio consistió en valuar la eficacia analgésica de la ropivacaína usada localmente contra la dipirona por vía intravenosa en colecistectomía laparoscópica. Métodos: ensayo clínico al azar, de no inferioridad, en 50 pacientes con colecistectomía laparoscópica para comparar el uso de ropivacaína al 0.75 % infiltrada en el lugar de inserción de los trócares y en la fosa vesicular frente a dipirona por vía intravenosa. El desenlace primario fue dolor evaluado mediante escala visual análoga (EVA) en las primeras 24 horas. Resultados: el promedio de las EVA de dolor al término de la cirugía fue de 3.8 frente a 3.56 en el grupo de ropivacaína o de dipirona, mientras que a las 6, 12 y 24 horas fueron 2.64 frente a 2.6, 1.92 frente a 1.88 y 1.28 frente a 1.2, respectivamente. No hubo efectos adversos en ningún grupo y la necesidad de rescates analgésicos con tramadol fue similar entre ambos grupos. Conclusiones: la ropivacaína al 0.75 % infiltrada en el lugar de inserción de los trócares y la fosa vesicular muestra una analgesia similar a la dipirona por vía intravenosa en las primeras 24 horas después de una colecistectomía laparoscópica, sin efectos adversos.
Assuntos
Amidas/administração & dosagem , Anestésicos Locais/administração & dosagem , Anti-Inflamatórios não Esteroides/administração & dosagem , Colecistectomia Laparoscópica , Dipirona/administração & dosagem , Dor Pós-Operatória/prevenção & controle , Administração Tópica , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Amidas/uso terapêutico , Anestésicos Locais/uso terapêutico , Anti-Inflamatórios não Esteroides/uso terapêutico , Dipirona/uso terapêutico , Esquema de Medicação , Feminino , Humanos , Injeções Intravenosas , Masculino , Pessoa de Meia-Idade , Ropivacaina , Resultado do Tratamento , Adulto JovemRESUMO
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.
Assuntos
Certificação/normas , Educação de Pós-Graduação em Medicina/normas , Avaliação Educacional/métodos , Reumatologia/educação , Competência Clínica/normas , Avaliação Educacional/normas , Humanos , México , Reprodutibilidade dos Testes , Reumatologia/normasRESUMO
Cost-minimization study to assess the annual direct costs of 2 antiresorptive strategies in postmenopausal women with low bone mineral densities (BMDs). Patients were randomly assigned to receive 70 mg of oral weekly alendronate or a 1-time 5mg of intravenous zoledronic acid. All medical and nonmedical direct costs were recorded for 1 yr. Student's t-test or the Chi-squared test was used. A total of 101 postmenopausal women were enrolled with a mean age of 58.3 ± 7.6 yr and a postmenopausal period of 13.5 ± 8.3 yr. A total of 50 patients completed 1 yr of alendronate and 51 patients received zoledronic acid. At baseline, no differences were seen between the 2 groups in anthropometric measures, comorbidities, and bone mineral density. The costs for medical attention for low bone mass were $81,532 (US Dollars) for the alendronate group and $69,251 for the zoledronic acid group; the cost per patient was $1631 in the alendronate group vs $1358 in the zoledronic acid group (p<0.0001). Therefore, zoledronic acid treatment provided an annual savings of 15% of the direct costs compared with oral alendronate treatment. Moreover, there was a significant increase in lumbar spine T-scores in the zoledronic acid group when compared with the alendronate group. Annual zoledronic acid infusion as an antiresorptive treatment in women with low BMD provides significant monetary savings when compared with weekly alendronate therapy for 1 yr. Zoledronic acid infusion is also linked to higher increase in BMD and compliance.
Assuntos
Alendronato/administração & dosagem , Conservadores da Densidade Óssea/administração & dosagem , Conservadores da Densidade Óssea/economia , Densidade Óssea/efeitos dos fármacos , Difosfonatos/administração & dosagem , Imidazóis/administração & dosagem , Osteoporose Pós-Menopausa/tratamento farmacológico , Absorciometria de Fóton , Administração Oral , Idoso , Alendronato/economia , Carbonato de Cálcio/administração & dosagem , Carbonato de Cálcio/economia , Controle de Custos , Difosfonatos/economia , Esquema de Medicação , Feminino , Humanos , Imidazóis/economia , Infusões Intravenosas , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/diagnóstico por imagem , Estudos Prospectivos , Resultado do Tratamento , Vitamina D/administração & dosagem , Vitamina D/economia , Ácido ZoledrônicoRESUMO
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.
Assuntos
Antirreumáticos/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Aprovação de Drogas , Farmacovigilância , Doenças Reumáticas/tratamento farmacológico , Aprovação de Drogas/legislação & jurisprudência , Humanos , MéxicoRESUMO
BACKGROUND: We undertook this study to describe prescription practices and the degree of disease control in a large sample of patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS) treated by rheumatologists in Mexico. METHODS: Board-certified Mexican rheumatologists across the country were asked to assess consecutive RA and AS patients; 1208 patients completed a self-administered questionnaire with information on demographics, disease duration, co-morbidity, treatment, pain, disability and a validated Spanish version of instruments to measure physical function and quality of life. RESULTS: Of the 1096 RA patients, 88.1% were treated with nonsteroidal anti-inflammatory drugs (NSAIDs), 1020 (93.3%) with disease-modifying anti-rheumatic drugs (DMARDs), 365 (33.4%) with steroids, and 70 (6.4%) with biological agents. Their mean Health Assessment Questionnaire Disability Index (HAQ-Di) score was 1.21+/-0.80, Disease Activity Index, 28 joint count (DAS 28) 3.9+/-1.29, and Rheumatoid Arthritis Disease Activity Index (RADAI), 3.94+/-2.01. Regarding the 112 AS patients, 110 (98.2%) received NSAIDs, 90 (80.4%) were on DMARDs, 11 (9.8%) took steroids, and 11 (9.8%) received biological agents, their functional status shown as Bath Ankylosing Spondylitis Functional Index (BASFI) score of 4.4+/-2.5. Among the 1110 DMARD users, only 64 received one drug, and a great proportion used two or more DMARDs; 81 subjects (16.2%) were on biological agents, in any combination. RA patients more commonly used methotrexate, 791 (72%) cases, and hydroxychloroquine. Taking into account their diagnosis, the combination most prescribed was NSAIDs plus DMARDs in 660 subjects (54.7%). CONCLUSIONS: DMARDs in combination with other drug are the most frequently prescribed therapeutic scheme for RA and AS patients. These schemes used for both conditions by Mexican rheumatologists are in line with current international recommendations.