RESUMO
The aim of this article is to evaluate the use of musculoskeletal ultrasound in the daily clinical practice of a rheumatology unit. We conducted a descriptive retrospective analysis of the ultrasound examinations performed during 2011 and a comparison of these examinations with those performed between 1998 and 2003 and between 2007 and 2008. A total of 712 ultrasound examinations performed in 2011 were reviewed. Out of the total, examinations of individual areas of the body represented 11.6% versus 45.9% of the examinations made between 2007 and 2008 and 100% of those performed before 2003. The remaining 88.4% of ultrasound examinations performed in 2011 were intended to investigate inflammation in 25.8%, differential diagnosis of arthralgia in 17.1%, enthesis in 12.6% and temporal arteries in 17.3%, and to conduct ultrasound-guided procedures in 10.6% and study microcrystalline pathologies in 4.7%. In our unit, ultrasonography is evolving from being a mere investigation of individual areas of the body to becoming a clinical information tool, which contributes to the diagnosis and monitoring of the disease activity in the patient as a whole.
Assuntos
Doenças Reumáticas/diagnóstico por imagem , Reumatologia , Ultrassonografia/métodos , Adulto , Idoso , Tornozelo/diagnóstico por imagem , Artralgia/diagnóstico por imagem , Articulações do Carpo/diagnóstico por imagem , Diagnóstico Diferencial , Feminino , Pé/diagnóstico por imagem , Articulação da Mão/diagnóstico por imagem , Humanos , Articulação do Joelho/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Cisto Popliteal/diagnóstico por imagem , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Estudos Retrospectivos , Sensibilidade e Especificidade , Ombro/diagnóstico por imagem , Ultrassonografia de Intervenção/métodosRESUMO
UNLABELLED: Changes of the bone formation marker PINP correlated positively with improvements in vertebral strength in men with glucocorticoid-induced osteoporosis (GIO) who received 18-month treatment with teriparatide, but not with risedronate. These results support the use of PINP as a surrogate marker of bone strength in GIO patients treated with teriparatide. INTRODUCTION: To investigate the correlations between biochemical markers of bone turnover and vertebral strength estimated by finite element analysis (FEA) in men with GIO. METHODS: A total of 92 men with GIO were included in an 18-month, randomized, open-label trial of teriparatide (20 µg/day, n = 45) and risedronate (35 mg/week, n = 47). High-resolution quantitative computed tomography images of the 12th thoracic vertebra obtained at baseline, 6 and 18 months were converted into digital nonlinear FE models and subjected to anterior bending, axial compression and torsion. Stiffness and strength were computed for each model and loading mode. Serum biochemical markers of bone formation (amino-terminal-propeptide of type I collagen [PINP]) and bone resorption (type I collagen cross-linked C-telopeptide degradation fragments [CTx]) were measured at baseline, 3 months, 6 months and 18 months. A mixed-model of repeated measures analysed changes from baseline and between-group differences. Spearman correlations assessed the relationship between changes from baseline of bone markers with FEA variables. RESULTS: PINP and CTx levels increased in the teriparatide group and decreased in the risedronate group. FEA-derived parameters increased in both groups, but were significantly higher at 18 months in the teriparatide group. Significant positive correlations were found between changes from baseline of PINP at 3, 6 and 18 months with changes in FE strength in the teriparatide-treated group, but not in the risedronate group. CONCLUSIONS: Positive correlations between changes in a biochemical marker of bone formation and improvement of biomechanical properties support the use of PINP as a surrogate marker of bone strength in teriparatide-treated GIO patients.
Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Glucocorticoides/efeitos adversos , Osteogênese/efeitos dos fármacos , Osteoporose/tratamento farmacológico , Teriparatida/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Fenômenos Biomecânicos/efeitos dos fármacos , Fenômenos Biomecânicos/fisiologia , Densidade Óssea/efeitos dos fármacos , Ácido Etidrônico/análogos & derivados , Ácido Etidrônico/uso terapêutico , Colo do Fêmur/fisiopatologia , Análise de Elementos Finitos , Humanos , Vértebras Lombares/fisiopatologia , Masculino , Pessoa de Meia-Idade , Osteogênese/fisiologia , Osteoporose/induzido quimicamente , Osteoporose/fisiopatologia , Fragmentos de Peptídeos/sangue , Pró-Colágeno/sangue , Ácido Risedrônico , Resultado do TratamentoRESUMO
OBJECTIVE: To estimate the minimum clinically important improvement (MCII) and patient acceptable symptom state (PASS) values for 4 generic outcomes in 5 rheumatic diseases and 7 countries. METHODS: We conducted a multinational (Australia, France, Italy, Lebanon, Morocco, Spain, and The Netherlands) 4-week cohort study involving 1,532 patients who were prescribed nonsteroidal antiinflammatory drugs for ankylosing spondylitis, chronic back pain, hand osteoarthritis, hip and/or knee osteoarthritis, or rheumatoid arthritis. The MCII and PASS values were estimated with the 75th percentile approach for 4 generic outcomes: pain, patient global assessment, functional disability, and physician global assessment, all normalized to a 0-100 score. RESULTS: For the whole sample, the estimated MCII values for absolute change at 4 weeks were -17 (95% confidence interval [95% CI] -18, -15) for pain; -15 (95% CI -16, -14) for patient global assessment; -12 (95% CI -13, -11) for functional disability assessment; and -14 (95% CI -15, -14) for physician global assessment. For the whole sample, the estimated PASS values were 42 (95% CI 40, 44) for pain; 43 (95% CI 41, 45) for patient global assessment; 43 (95% CI 41, 44) for functional disability assessment; and 39 (95% CI 37, 40) for physician global assessment. Estimates were consistent across diseases and countries (for subgroups ≥20 patients). CONCLUSION: This work allows for promoting the use of values of MCII (15 of 100 for absolute improvement, 20% for relative improvement) and PASS (40 of 100) in reporting the results of trials of any of the 5 involved rheumatic diseases with pain, patient global assessment, physical function, or physician global assessment used as outcome criteria.
Assuntos
Avaliação da Deficiência , Satisfação do Paciente/estatística & dados numéricos , Doenças Reumáticas/diagnóstico , Doenças Reumáticas/psicologia , Índice de Gravidade de Doença , Adulto , Idoso , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/psicologia , Artrite Reumatoide/terapia , Dor nas Costas/diagnóstico , Dor nas Costas/psicologia , Dor nas Costas/terapia , Dor Crônica/diagnóstico , Dor Crônica/psicologia , Dor Crônica/terapia , Estudos de Coortes , Feminino , Humanos , Internacionalidade , Masculino , Pessoa de Meia-Idade , Osteoartrite do Quadril/diagnóstico , Osteoartrite do Quadril/psicologia , Osteoartrite do Quadril/terapia , Osteoartrite do Joelho/diagnóstico , Osteoartrite do Joelho/psicologia , Osteoartrite do Joelho/terapia , Estudos Prospectivos , Doenças Reumáticas/terapia , Espondilite Anquilosante/diagnóstico , Espondilite Anquilosante/psicologia , Espondilite Anquilosante/terapia , Resultado do TratamentoRESUMO
OBJECTIVE: To develop evidence-based recommendations on how to investigate and follow-up undifferentiated peripheral inflammatory arthritis (UPIA). METHODS: 697 rheumatologists from 17 countries participated in the 3E (Evidence, Expertise, Exchange) Initiative of 2008-9 consisting of three separate rounds of discussions and modified Delphi votes. In the first round 10 clinical questions were selected. A bibliographic team systematically searched Medline, Embase, the Cochrane Library and ACR/EULAR 2007-2008 meeting abstracts. Relevant articles were reviewed for quality assessment, data extraction and synthesis. In the second round each country elaborated a set of national recommendations. Finally, multinational recommendations were formulated and agreement among the participants and the potential impact on their clinical practice was assessed. RESULTS: A total of 39,756 references were identified, of which 250 were systematically reviewed. Ten multinational key recommendations about the investigation and follow-up of UPIA were formulated. One recommendation addressed differential diagnosis and investigations prior to establishing the operational diagnosis of UPIA, seven recommendations related to the diagnostic and prognostic value of clinical and laboratory assessments in established UPIA (history and physical examination, acute phase reactants, autoantibodies, radiographs, MRI and ultrasound, genetic markers and synovial biopsy), one recommendation highlighted predictors of persistence (chronicity) and the final recommendation addressed monitoring of clinical disease activity in UPIA. CONCLUSIONS: Ten recommendations on how to investigate and follow-up UPIA in the clinical setting were developed. They are evidence-based and supported by a large panel of rheumatologists, thus enhancing their validity and practical use.
Assuntos
Artrite/diagnóstico , Artrite Reumatoide/diagnóstico , Biomarcadores/sangue , Diagnóstico Diferencial , Medicina Baseada em Evidências/métodos , Humanos , Cooperação Internacional , Assistência de Longa Duração/métodos , Prognóstico , Índice de Gravidade de DoençaRESUMO
OBJECTIVES: Studies on the incidence of spondyloarthritis (SpA) are scarce. Early SpA clinics should facilitate the detection of new cases as well as to decrease the diagnosis and treatment delay. However, the workload of such clinics has not been estimated. METHODS: ESPIDEP is a pilot registry of patients with early SpA performed in Madrid, Spain. General practitioners (GPs) agreed and were trained to refer all patients under 45 with either inflammatory back pain or asymmetric arthritis of lower limbs with 3 to 24 month duration of symptoms to a specialised unit during 6 consecutive months. Case definition of SpA was based on the ESSG criteria. The success of the program was measured by: the satisfaction of the GPs regarding the referral process, the percentage of patients correctly derived according to the rheumatologist, the expected incidence of AS. RESULTS: From a population of 111,941, the unit attended 52 patients, of whom 43 (83%) had been derived correctly and 35 were diagnosed with SpA (49% women; mean age 33+/-8; mean duration of symptoms 11+/-6 months; 46% HLA-B27 positive). The annual estimated incidence of SpA was 62.5 cases per 100,000 (95% CI: 45-87). Only 20/35 (57%) had radiological sacroiliitis and 4 (11.8%) fulfilled the modified New York criteria for ankylosing spondylitis (annual estimated incidence 7.2 per 100,000 (IC95%: 3.1-14.1)). CONCLUSIONS: Around 60 cases of early SpA are expected annually in an area of 100,000. A referral based upon clinical parameters seems efficient. The planning of early SpA clinics may be based upon these figures.
Assuntos
Sistema de Registros , Espondilartrite/etnologia , Espondilartrite/epidemiologia , Adulto , Efeitos Psicossociais da Doença , Feminino , Antígeno HLA-B27/sangue , Humanos , Incidência , Masculino , Projetos Piloto , Encaminhamento e Consulta , Espanha/epidemiologia , Espondilartrite/sangueRESUMO
OBJECTIVES: To assess long-term safety and clinical efficacy of etanercept 25 mg subcutaneously twice weekly up to 5 years in subjects with ankylosing spondylitis (AS). METHODS: An open-label (OL), multicentre, phase 4, 156-week extension study of subjects with AS who had completed a 12-week randomised, placebo-controlled study (N=84; n=45 etanercept, n=39 placebo) followed by a 96-week OL study (n=81; n=42 etanercept/etanercept; n=39 placebo/etanercept); 59 subjects who completed the 96-week OL extension enrolled in the current OL trial and continued etanercept 25 mg BIW for an additional 156 weeks (total duration: 264 weeks, original etanercept group; 252 weeks, original placebo group). Safety was based on spontaneous reports of adverse events (AEs). Last observation carried forward was used for imputation of missing values. RESULTS: Thirty-seven of 59 subjects (63%) completed 5 years of etanercept treatment. Serious non infectious AEs and serious infections occurred at a rate of 0.17 and 0.03 events per subject years, respectively; inflammatory bowel disease and uveitis (including iritis and iridiocyclitis) occurred at 0.01 and 0.14, respectively. No cases of tuberculosis or opportunistic infections were reported. Assessment in Ankylosing Spondylitis (ASAS) responses and improvements in Bath Ankylosing Spondylitis Functional Index and spinal mobility were sustained from week 108 through week 264. CONCLUSIONS: Etanercept was well tolerated with no new safety signals detected in subjects with AS over 5 years. Clinical efficacy and improvements in function and mobility seen during the double-blind and first OL study were sustained. These results support etanercept therapy for the long-term management of this chronic disease.
Assuntos
Antirreumáticos/administração & dosagem , Imunoglobulina G/administração & dosagem , Satisfação do Paciente , Receptores do Fator de Necrose Tumoral/administração & dosagem , Espondilite Anquilosante/tratamento farmacológico , Atividades Cotidianas , Adulto , Antirreumáticos/efeitos adversos , Etanercepte , Feminino , Humanos , Imunoglobulina G/efeitos adversos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Atividade Motora , Resultado do TratamentoRESUMO
OBJECTIVES: To determine clinical and ultrasonographic predictors of joint replacement surgery across Europe in primary osteoarthritis (OA) of the knee. METHODS: This was a 3-year prospective study of a painful OA knee cohort (from a EULAR-sponsored, multicentre study). All subjects had clinical evaluation, radiographs and ultrasonography (US) at study entry. The rate of knee replacement surgery over the 3-year follow-up period was determined using Kaplan-Meier survival data analyses. Predictive factors for joint replacement were identified by univariate log-rank test then multivariate analysis using a Cox proportional-hazards regression model. Potential baseline predictors included demographic, clinical, radiographic and US features. RESULTS: Of the 600 original patients, 531 (88.5%), mean age 67+/-10 years, mean disease duration 6.1+/-6.9 years, had follow-up data and were analysed. During follow-up (median 3 years; range 0-4 years), knee replacement was done or required for 94 patients (estimated event rate of 17.7%). In the multivariate analysis, predictors of joint replacement were as follows: Kellgren and Lawrence radiographic grade (grade > or =III vs
Assuntos
Artroplastia do Joelho , Osteoartrite do Joelho/cirurgia , Idoso , Progressão da Doença , Métodos Epidemiológicos , Exsudatos e Transudatos/diagnóstico por imagem , Feminino , Humanos , Articulação do Joelho/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/diagnóstico por imagem , Medição da Dor , Prognóstico , Radiografia , UltrassonografiaRESUMO
AIM: To conduct a multi-language translation and cross-cultural adaptation of the Intermittent and Constant OsteoArthritis Pain (ICOAP) questionnaire for hip and knee osteoarthritis (OA). METHODS: The questionnaires were translated and cross-culturally adapted in parallel, using a common protocol, into the following languages: Czech, Dutch, French (France), German, Italian, Norwegian, Spanish (Castillan), North and Central American Spanish, Swedish. The process was conducted following five steps: (1)--independent translation into the target language by two or three persons; (2)--consensus meeting to obtain a single preliminary translated version; (3)--backward translation by an independent bilingual native English speaker, blinded to the English original version; (4)--final version produced by a multidisciplinary consensus committee; (5)--pre-testing of the final version with 10-20 target-language-native hip and knee OA patients. RESULTS: The process could be followed and completed in all countries. Only slight differences were identified in the structure of the sentences between the original and the translated versions. A large majority of the patients felt that the questionnaire was easy to understand and complete. Only a few minor criticisms were expressed. Moreover, a majority of patients found the concepts of constant pain and pain that comes and goes to be of a great pertinence and were very happy with the distinction. CONCLUSION: The ICOAP questionnaire is now available for multi-center international studies.
Assuntos
Comparação Transcultural , Osteoartrite do Quadril/diagnóstico , Osteoartrite do Joelho/diagnóstico , Medição da Dor , Inquéritos e Questionários/normas , Traduções , Humanos , IdiomaRESUMO
OBJECTIVES: To develop evidence-based recommendations for the diagnosis of hand osteoarthritis (OA). METHODS: The multidisciplinary guideline development group, representing 15 European countries, generated 10 key propositions regarding diagnosis using a Delphi consensus approach. For each recommendation, research evidence was searched for systematically. Whenever possible, the sensitivity, specificity and likelihood ratio (LR) were calculated; relative risk and odds ratios were estimated for risk factors for hand OA. Quality of evidence was categorised using the European League Against Rheumatism (EULAR) hierarchy, and strength of recommendation was assessed by the EULAR visual analogue scale. RESULTS: Diagnostic topics included clinical manifestations, radiographic features, subgroups, differential diagnosis, laboratory tests, risk factors and comorbidities. The sensitivity, specificity and LR varied between tests depending upon the cut-off level, gold standard and controls. Overall, no single test could be used to define hand OA on its own (LR <10) but a composite of the tests greatly increased the chance of the diagnosis. The probability of a subject having hand OA was 20% when Heberden nodes alone were present, but this increased to 88% when in addition the subject was over 40 years old, had a family history of nodes and had joint space narrowing in any finger joint. CONCLUSION: Ten key recommendations for diagnosis of hand OA were developed using research evidence and expert consensus. Diagnosis of hand OA should be based on assessment of a composite of features.
Assuntos
Medicina Baseada em Evidências/métodos , Articulação da Mão/diagnóstico por imagem , Osteoartrite/diagnóstico , Adulto , Artrite Psoriásica/diagnóstico , Artrite Reumatoide/diagnóstico , Diagnóstico Diferencial , Feminino , Hemocromatose/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite/etiologia , Radiografia , Fatores de RiscoRESUMO
AIMS: To evaluate the efficacy of methotrexate (MTX) in preventing the recurrence of acute anterior uveitis (AAU). METHODS: This prospective, open, longitudinal study included patients from June 2002 to March 2005 who had either three or more episodes of AAU in the previous year, or a recurrence of AAU within 3 months before starting the trial. We excluded uveitis of infectious origin, masquerade syndromes, and patients with contraindications to MTX. The response criteria were defined as an absence of symptoms and the presence of a normal ophthalmologic examination. The study outcome compared the number of flare-ups of uveitis over an MTX-treated for 1 year to the number of flare-ups of the same group during the previous year without MTX. RESULTS: A total of 571 patients with uveitis were evaluated during the period of the study, and 10 fulfilled the inclusion criteria. One patient refused the treatment, and nine completed the study. The mean number of recurrences in the pre-MTX year was 3.4 (SD: 0.52), which was significantly reduced to 0.89 (SD: 1.17) in the year of treatment (P=0.011). CONCLUSION: MTX treatment seems to reduce the number of flare-ups in patients with recurrent AAU.
Assuntos
Inibidores Enzimáticos/uso terapêutico , Imunossupressores/uso terapêutico , Metotrexato/uso terapêutico , Uveíte Anterior/prevenção & controle , Adolescente , Adulto , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Prevenção Secundária , Adulto JovemRESUMO
OBJECTIVE: To determine the effect of changing from etanercept or methotrexate monotherapy to etanercept plus methotrexate combination therapy on radiographic progression in rheumatoid arthritis (RA) patients. METHODS: Patients enrolled in this 1-year open-label study previously completed a 3-year blinded study in which they received methotrexate or etanercept monotherapy or the combination of both. All patients received the combination of etanercept 25 mg subcutaneously twice weekly plus oral methotrexate up to 20 mg/week. The primary radiographic endpoint was a change in modified total Sharp score (TSS), as assessed by blinded readers. RESULTS: At baseline, patients previously receiving methotrexate monotherapy (etanercept-added, n = 52) or etanercept monotherapy (methotrexate-added, n = 68) had moderate disease activity levels (mean disease activity score (DAS) of 2.6 and 2.5, respectively), whereas patients previously receiving combination therapy (n = 90) had a low disease activity level (mean DAS of 2.0). The addition of etanercept to methotrexate monotherapy resulted in a significant reduction in radiographic progression (p<0.05). Mean TSS changes in the previous year versus the current year were +1.79 versus +0.25 for the etanercept-added group (p<0.05); +0.51 versus -0.18 for the methotrexate-added group (NS) and +0.42 versus +0.24 for the combination group (NS). CONCLUSION: In these RA patients with on average moderate disease activity despite previous methotrexate monotherapy, combination treatment with etanercept and methotrexate inhibited radiographic progression and improved radiographic outcomes. These data, in conjunction with the previously published clinical data, support the use of combination therapy in RA patients with moderate disease activity.
Assuntos
Antirreumáticos/administração & dosagem , Artrite Reumatoide/tratamento farmacológico , Imunoglobulina G/administração & dosagem , Metotrexato/administração & dosagem , Receptores do Fator de Necrose Tumoral/administração & dosagem , Progressão da Doença , Método Duplo-Cego , Quimioterapia Combinada , Etanercepte , Humanos , Resultado do TratamentoRESUMO
OBJECTIVES: To develop evidence-based recommendations for the use of methotrexate in daily clinical practice in rheumatic disorders. METHODS: 751 rheumatologists from 17 countries participated in the 3E (Evidence, Expertise, Exchange) Initiative of 2007-8 consisting of three separate rounds of discussions and Delphi votes. Ten clinical questions concerning the use of methotrexate in rheumatic disorders were formulated. A systematic literature search in Medline, Embase, Cochrane Library and 2005-7 American College of Rheumatology/European League Against Rheumatism meeting abstracts was conducted. Selected articles were systematically reviewed and the evidence was appraised according to the Oxford levels of evidence. Each country elaborated a set of national recommendations. Finally, multinational recommendations were formulated and agreement among the participants and the potential impact on their clinical practice was assessed. RESULTS: A total of 16 979 references was identified, of which 304 articles were included in the systematic reviews. Ten multinational key recommendations on the use of methotrexate were formulated. Nine recommendations were specific for rheumatoid arthritis (RA), including the work-up before initiating methotrexate, optimal dosage and route, use of folic acid, monitoring, management of hepatotoxicity, long-term safety, mono versus combination therapy and management in the perioperative period and before/during pregnancy. One recommendation concerned methotrexate as a steroid-sparing agent in other rheumatic diseases. CONCLUSIONS: Ten recommendations for the use of methotrexate in daily clinical practice focussed on RA were developed, which are evidence based and supported by a large panel of rheumatologists, enhancing their validity and practical use.
Assuntos
Antirreumáticos/administração & dosagem , Metotrexato/administração & dosagem , Doenças Reumáticas/tratamento farmacológico , Anormalidades Induzidas por Medicamentos/etiologia , Administração Oral , Antirreumáticos/efeitos adversos , Quimioterapia Combinada , Medicina Baseada em Evidências , Feminino , Ácido Fólico/administração & dosagem , Humanos , Assistência de Longa Duração , Masculino , Metotrexato/efeitos adversos , Cuidado Pré-Concepcional , Fatores de RiscoRESUMO
OBJECTIVES: To develop an ultrasound enthesis score and to assess its validity in the diagnostic classification of the spondyloarthropathies (SpAs). METHODS: Twenty-five patients with SpA and 29 healthy controls participated in a blinded, gender-matched, cross-sectional study involving ultrasound assessment. The following entheses were explored bilaterally: proximal plantar fascia, distal Achilles tendon, distal and proximal patellar ligament, distal quadriceps and brachial triceps tendons. The ultrasound score evaluated enthesis thickness, structure, calcifications, erosions, bursae and power Doppler signal. The value of each elemental lesion was calculated using a three-model analysis. Validity was analysed by receiver operating characteristic (ROC) curves. Inter-reader and interexplorer intraclass correlation coefficients (ICCs) were calculated. RESULTS: The logistic regression model overestimated the score of three elemental lesions: calcification (0-3), Doppler (0 or 3) and erosion (0 or 3), while scoring tendon structure, tendon thickness and bursa as 0 or 1. ROC curves established an ultrasound score of >or=18 as the best cut-off point for differentiation between cases and controls. This cut-off point was exceeded by 5/29 controls (17%) and by 21/25 patients with SpA (84%). The sensitivity, specificity, positive and negative likelihood ratios (LR+, LR-) were 83.3%, 82.8%, 4.8% and 0.2%, respectively. The inter-reader and interexplorer ICCs were 0.60 and 0.86, respectively. CONCLUSION: The findings suggest that the ultrasound enthesis score could be a valid tool in the diagnosis of SpA.
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Espondiloartropatias/diagnóstico por imagem , Tendões/diagnóstico por imagem , Tendão do Calcâneo/diagnóstico por imagem , Adolescente , Adulto , Idoso , Bursite/diagnóstico por imagem , Calcâneo/diagnóstico por imagem , Métodos Epidemiológicos , Fasciíte Plantar/diagnóstico por imagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Ligamento Patelar/diagnóstico por imagem , Ultrassonografia , Adulto JovemRESUMO
OBJECTIVE: To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). METHODS: The project followed the EULAR standardized operating procedures, which use a three-step approach: 1) expert-based definition of relevant research questions (November 2006); 2) systematic literature search (November 2006 to May 2007); and 3) expert consensus on recommendations based on the literature search results (May 2007). In addition, since this is the first joint EULAR/ACR publication on recommendations, an extra step included a meeting with an ACR panel to approve the recommendations elaborated by the expert group (August 2007). RESULTS: Eleven relevant questions were identified for the literature search. Based on the evidence from the literature, the expert panel recommended that each trial should report the following items: 1) disease activity response and disease activity states; 2) appropriate descriptive statistics of the baseline, the endpoints and change of the single variables included in the core set; 3) baseline disease activity levels (in general); 4) the percentage of patients achieving a low disease activity state and remission; 5) time to onset of the primary outcome; 6) sustainability of the primary outcome; 7) fatigue. CONCLUSION: These recommendations endorsed by EULAR and ACR will help harmonize the presentations of results from clinical trials. Adherence to these recommendations will provide the readership of clinical trials with more details of important outcomes, while the higher level of homogeneity may facilitate the comparison of outcomes across different trials and pooling of trial results, such as in meta-analyses.
Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Ensaios Clínicos como Assunto/normas , Medicina Baseada em Evidências/métodos , Comportamento Cooperativo , HumanosRESUMO
OBJECTIVE: To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). METHODS: The project followed the EULAR standardised operating procedures, which use a three-step approach: (1) expert-based definition of relevant research questions (November 2006); (2) systematic literature search (November 2006 to May 2007); and (3) expert consensus on recommendations based on the literature search results (May 2007). In addition, since this is the first joint EULAR/ACR publication on recommendations, an extra step included a meeting with an ACR panel to approve the recommendations elaborated by the expert group (August 2007). RESULTS: Eleven relevant questions were identified for the literature search. Based on the evidence from the literature the expert panel recommended that each trial should report the following items: (1) disease activity response and disease activity states; (2) appropriate descriptive statistics of the baseline, the endpoints and change of the single variables included in the core set; (3) baseline disease activity levels (in general); (4) the percentage of patients achieving a low disease activity state and remission; (5) time to onset of the primary outcome; (6) sustainability of the primary outcome; (7) fatigue. CONCLUSIONS: These recommendations endorsed by EULAR and ACR will help harmonise the presentations of results from clinical trials. Adherence to these recommendations will provide the readership of clinical trials with more details of important outcomes, while the higher level of homogeneity may facilitate the comparison of outcomes across different trials and pooling of trial results, such as in meta-analyses.
Assuntos
Artrite Reumatoide/diagnóstico , Artrite Reumatoide/tratamento farmacológico , Ensaios Clínicos como Assunto/normas , Índice de Gravidade de Doença , Artrite Reumatoide/complicações , Ensaios Clínicos como Assunto/métodos , Medicina Baseada em Evidências/métodos , Fadiga/diagnóstico , Fadiga/etiologia , Humanos , Cooperação Internacional , Indução de Remissão , Projetos de Pesquisa/normas , Sociedades Médicas , Resultado do TratamentoRESUMO
OBJECTIVE: To use an evidence-based and consensus-based approach to elaborate recommendations on how to report disease activity in clinical trials of patients with rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). METHODS: After an initial expert meeting, during which relevant research questions were identified, a systematic literature search was performed using Medline, Embase and the Cochrane Library as sources. To ensure literature retrieved was comprehensive, we emphasised search algorithms that were sensitive rather than specific. The results of the literature search were discussed by the expert panel, modified and expanded, and were used as the basis for the elaboration of the recommendation in the consensus process. Finally, an independent ACR panel approved these items with some minor modifications. RESULTS: The following pieces of evidence were obtained from the literature search: (1) timing and the sustaining of a response is relevant to achieve better outcomes; (2) composite disease activity indices have been used to define low disease activity and remission and these definitions have been validated as has the American Rheumatism Association (ARA) remission criteria. The "patient-reported symptom state" (PASS) is not yet well validated; (3) evidence was obtained to identify those measures, scales and patient-reported instruments, for which there is a documented association with relevant outcomes; (4) baseline disease activity is associated with disease activity levels at the end of follow-up; and (5) there was not sufficient evidence relating the added benefit of MRI or ultrasound over clinical assessments. Most data stemmed from observational studies rather than clinical trials and literature review was supplemented by input from experts. The results served as the basis for the elaboration of the seven recommendations by the experts. CONCLUSIONS: The approach based on scientific evidence from the literature as well as on expert input provided sufficient information to derive recommendations on reporting disease activity in RA clinical trials. The methodology, results and conclusions of this project were endorsed by EULAR and the ACR.
Assuntos
Artrite Reumatoide/diagnóstico , Artrite Reumatoide/tratamento farmacológico , Ensaios Clínicos como Assunto/normas , Conferências de Consenso como Assunto , Índice de Gravidade de Doença , Artrite Reumatoide/complicações , Ensaios Clínicos como Assunto/métodos , Medicina Baseada em Evidências/métodos , Fadiga/etiologia , Humanos , Armazenamento e Recuperação da Informação/normas , Cooperação Internacional , Sinovite/diagnóstico , Sinovite/etiologia , Resultado do TratamentoAssuntos
Antirreumáticos/uso terapêutico , Artrite Psoriásica/tratamento farmacológico , Espondilite Anquilosante/tratamento farmacológico , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Uveíte/etiologia , Adulto , Anticorpos Monoclonais/uso terapêutico , Etanercepte , Feminino , Humanos , Imunoglobulina G/efeitos adversos , Imunoglobulina G/uso terapêutico , Infliximab , Masculino , Pessoa de Meia-Idade , Razão de Chances , Receptores do Fator de Necrose Tumoral/uso terapêutico , Estudos RetrospectivosRESUMO
UNLABELLED: In this observational study of women with an inadequate clinical outcome to osteoporosis therapy, those with a fracture at baseline were more likely to sustain an incident fracture and have a worse health-related quality of life than those without prior fracture. INTRODUCTION: The Observational Study of Severe Osteoporosis (OSSO) was designed to assess the fracture incidence and health-related quality of life (HRQoL) in women with an inadequate clinical outcome to osteoporosis therapy. METHODS: Post-menopausal women (N=1,885) with established osteoporosis and an inadequate clinical response to osteoporosis drug therapy defined as: a) a fragility fracture despite therapy for one year (index fracture, N=988), or b) discontinued drug therapy due to adverse effects and/or non-compliance (N=897), were assessed during one year for HRQoL using the EQ-5D and the QUALEFFO questionnaires. RESULTS: One hundred and sixty-six (8.8%) women had a total of 209 incident fractures (1,139 fractures/10,000 women-years). Women with an index fracture were more likely to sustain an incident fracture than those without prior fractures (hazard ratio 1.91; 95% CI: 1.37-2.66; p<0.001). Co-morbidities or antidepressant use at baseline also increased the risk of incident fracture. Median total EQ-5D Health State Values and QUALEFFO scores were worse in women with an incident fracture regardless of index fracture status. The worst scores were reported in the EQ-5D sub-domains of self-care, usual activities and pain/discomfort. CONCLUSIONS: Women with an inadequate response to osteoporosis therapy had a high rate of incident fracture which had an adverse impact on HRQoL.