RESUMO
Despite a qualitatively and structurally good care of patients with rheumatoid arthritis (RA) in Germany, there are still potentially amendable deficits in the quality of care. For this reason, the German Society for Rheumatology (DGRh) has therefore decided to ask a group of experts including various stakeholders to develop quality standards (QS) for the care of patients with RA in order to improve the quality of care. The QS are used to determine and quantitatively measure the quality of care, subject to relevance and feasibility. The recently published NICE and ASAS standards and a systematic literature search were used as the basis for development. A total of 8 QS, now published for the first time, were approved with the intention to measure and further optimize the quality of care for patients with RA in Germany.
Assuntos
Artrite Reumatoide , Reumatologia , Humanos , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/terapia , AlemanhaRESUMO
Quality standards (QS) are measurable constructs designed to quantify gaps in care and subsequently to improve quality of care. The Assessment of SpondyloArthritis International Society (ASAS) recently generated and published international QS for the management of patients with axial spondyloarthritis (axSpA) for the first time. The German Society of Rheumatology (DGRh) then decided to translate, review and possibly adopt these standards by a group of experts from different care settings. Against this background, national QS for the management of patients with axSpA for Germany were developed for the first time. The main focus was on feasibility and practical relevance. Ultimately, nine QS were defined with which the quality of care in Germany can and should be measured and improved.
Assuntos
Espondiloartrite Axial , Reumatologia , Espondilartrite , Espondilite Anquilosante , Humanos , Espondilartrite/diagnóstico , Espondilartrite/terapia , AlemanhaRESUMO
A comprehensive health policy quality campaign launched in 2021 aims to improve the quality and transparency of hospital care for people with diseases in Germany. Legal requirements for minimum volumes and the expansion of quality contracts between cost units and hospitals as well as the use of quality indicators relevant to planning for demand-oriented and quality-oriented further development of inpatient care will increase competition in the quality of care between hospitals. The topic of development and definition of quality in medicine was also comprehensively addressed by the Association of Rheumatological Acute Care Clinics (VRA) shortly after its foundation in 1998. At the center of acute inpatient quality management are binding structural criteria linked to the continuous outcome benchmarking in acute rheumatology care (KOBRA) project launched in 2003 in rheumatology (and continuously implemented to date) measuring process and outcome quality. Based on this framework (fulfillment of the structural quality and participation in the KOBRA project) successfully participating rheumatology units can acquire the KOBRA seal of approval for 2 years at a time, which is awarded by the project management, the aQua Institute. The outstanding position of the project is exemplified by data evaluation on treatment change in active rheumatoid arthritis, diagnosis confirmation of connective tissue diseases and vasculitis during the inpatient stay as well as on participatory decision-making processes concerning rheumatoid arthritis (referring to the results of the data collection period 2018). By anchoring projects for structural, process and outcome quality acute inpatient rheumatology is well prepared for the paradigm shift demanded by health policies. Additionally, the KOBRA project is a good prerequisite to meet the requirements concerning quality management fixed in the Federal Joint Committee (G-BA) guidelines for recognition as a rheumatology center.
Assuntos
Artrite Reumatoide , Reumatologia , Alemanha , Hospitalização , Humanos , Pacientes InternadosRESUMO
Systemic disease demands systemic thinkers. In this mission statement we define rheumatology, describe the role of the German Society of Rheumatology and the rheumatologist's spirit to their discipline. Rheumatologists are dedicated to improving the quality of life of their acute, chronic, and rehabilitative patients on the basis of up to date evidence and strong physician-patient relations. We think, act and interact systemically, scientifically, consistently, transparently, reliably, inclusively, innovatively and enthusiastically.
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Reumatologistas , Reumatologia , Humanos , Relações Médico-Paciente , Qualidade de Vida , Sociedades MédicasRESUMO
Systemic disease demands systemic thinkers. In this mission statement we define rheumatology, describe the role of the German Society of Rheumatology and the rheumatologist's spirit to their discipline. Rheumatologists are dedicated to improving the quality of life of their acute, chronic, and rehabilitative patients on the basis of up to date evidence and strong physician-patient relations. We think, act and interact systemically, scientifically, consistently, transparently, reliably, inclusively, innovatively and enthusiastically.
Assuntos
Relações Médico-Paciente , Reumatologistas , Reumatologia , Alemanha , Humanos , Assistência Centrada no Paciente , Qualidade de VidaRESUMO
OBJECTIVE: The aim of this study was to compare radiographic progression in patients with ankylosing spondylitis (AS) treated for up to 2 years with secukinumab (MEASURE 1) with a historical cohort of biologic-naïve patients treated with NSAIDs (ENRADAS). METHODS: Baseline and 2-year lateral cervical and lumbar spine radiographs were independently evaluated using mSASSS by two readers, who were blinded to the chronology and cohort of the radiographs. The primary endpoint was the proportion of patients with no radiographic progression (mSASSS change ≤ 0 from baseline to year 2). The Primary Analysis Set included patients with baseline (≤ day 30) and post-baseline day 31-743 radiographs. Sensitivity analyses were performed to assess the robustness of the comparison between the two cohorts, as follows: Sensitivity Analysis Set 1 included all patients with baseline (≤ day 30) and year 2 (days 640-819) radiographs; Sensitivity Analysis Set 2 included all patients with baseline and post-baseline (> day 30) radiographs. RESULTS: A total of 168 patients (84%) from the MEASURE 1 cohort and 69 (57%) from the ENRADAS cohort qualified for the Primary Analysis Set. Over 2 years, the LS (SE) mean change from baseline in mSASSS for the primary analysis was 0.55 (0.139) for MEASURE 1 vs 0.89 (0.216) for ENRADAS (p = 0.1852). Mean changes from baseline in mSASSS were lower in MEASURE 1 vs ENRADAS for the primary and sensitivity analyses. The proportion of patients with no radiographic progression was consistently higher in the MEASURE 1 vs ENRADAS cohort across all cutoffs for no radiographic progression (change in mSASSS from baseline to year 2 of ≤ 0, ≤ 0.5, ≤ 1, and ≤ 2), but the differences were not statistically significant. CONCLUSION: Secukinumab-treated patients demonstrated a numerical, but statistically non-significant, higher proportion of non-progressors and lower change in mSASSS over 2 years versus a cohort of biologic-naïve patients treated with NSAIDs.
Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Vértebras Cervicais/diagnóstico por imagem , Vértebras Lombares/diagnóstico por imagem , Radiografia/métodos , Espondilite Anquilosante/tratamento farmacológico , Adolescente , Adulto , Idoso , Progressão da Doença , Feminino , Seguimentos , Humanos , Interleucina-17 , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Espondilite Anquilosante/diagnóstico , Fatores de Tempo , Adulto JovemRESUMO
Spondyloarthritides (SpA) are inflammatory rheumatic diseases affecting the axial skeleton, peripheral joints and entheses, and also manifest at extraskeletal sites. According to the more recently introduced nomenclature, predominant axial SpA is distinguished from predominant peripheral SpA. Axial SpA is further divided into radiographic and nonradiographic axial SpA. Genetic factors are relevant, with HLA-B27 being most important. The interleukin 23/17 pathway seems to be relevant and points towards new therapeutic targets. Inflammatory back pain is the leading symptom in axial SpA and has certain characteristics. In addition, HLA-B27 and sacroiliitis on imaging are important for diagnosis. Therapy consists of physiotherapy, nonsteroidal anti-inflammatory drugs (first line) and biologicals (second line). Conventional disease-modifying antirheumatic drugs are effective only in peripheral arthritis.
Assuntos
Espondilite Anquilosante/diagnóstico , Anti-Inflamatórios não Esteroides/uso terapêutico , Produtos Biológicos/uso terapêutico , Terapia por Exercício , Antígeno HLA-B27/genética , Humanos , Interleucina-17/fisiologia , Interleucina-23/fisiologia , Sacroileíte/diagnóstico , Sacroileíte/genética , Sacroileíte/imunologia , Sacroileíte/terapia , Transdução de Sinais/fisiologia , Espondilite Anquilosante/genética , Espondilite Anquilosante/imunologia , Espondilite Anquilosante/terapia , Fator de Necrose Tumoral alfa/antagonistas & inibidoresRESUMO
Acute anterior uveitis (AAU) is the most frequent uveitis subtype. It is often associated with HLA-B27 and with inflammatory rheumatic diseases, in particular with spondyloarthritis (SpA), which itself is strongly associated with HLA-B27. About 40-60% of patients with AAU have an associated spondyloarthritis, and 20-40% of patients with spondyloarthritis also have uveitis. The incidence of AAU in patients with SpA clearly correlates with disease duration. The AAU has an acute onset, usually affects only one eye at a time, and shows a tendency for recurrence. Early therapy of AAU with topical steroids is relevant for good visual outcomes. Minimum duration of therapy of flares of AAU is 6-8 weeks in order to prevent early recurrency. The rate of local complications correlates with the rate of AAU flares and the visual outcome is often good. Refractory uveitis and frequent recurrencies of AAU may be treated with conventional disease-modifying antirheumatic drugs (DMARDs, such as sulfasalazine and methotrexate) and biologicals (e.g. TNF-alpha inhibitors). Any first episode of AAU diagnosed by an ophthalmologist should prompt referral to rheumatology for suspected SpA, particularly if rheumatic symptoms are present.
Assuntos
Espondiloartropatias/diagnóstico , Uveíte Anterior/diagnóstico , Administração Tópica , Corticosteroides/uso terapêutico , Antirreumáticos/uso terapêutico , Antígeno HLA-B27/genética , Humanos , Comunicação Interdisciplinar , Colaboração Intersetorial , Metotrexato/uso terapêutico , Prognóstico , Espondiloartropatias/tratamento farmacológico , Espondiloartropatias/genética , Sulfassalazina/uso terapêutico , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Uveíte Anterior/tratamento farmacológico , Uveíte Anterior/genéticaRESUMO
Spondyloarthritides (SpA) are inflammatory rheumatic diseases affecting the axial skeleton, peripheral joints and entheses, and also manifest at extraskeletal sites. According to the more recently introduced nomenclature, predominant axial SpA is distinguished from predominant peripheral SpA. Axial SpA is further divided into radiographic and nonradiographic axial SpA. Genetic factors are relevant, with HLA-B27 being most important. The interleukin 23/17 pathway seems to be relevant and points towards new therapeutic targets. Inflammatory back pain is the leading symptom in axial SpA and has certain characteristics. In addition, HLA-B27 and sacroiliitis on imaging are important for diagnosis. Therapy consists of physiotherapy, nonsteroidal anti-inflammatory drugs (first line) and biologicals (second line). Conventional disease-modifying antirheumatic drugs are effective only in peripheral arthritis.
Assuntos
Espondilartrite , Anti-Inflamatórios não Esteroides/uso terapêutico , Antirreumáticos/uso terapêutico , Antígeno HLA-B27/genética , Humanos , Sacroileíte/diagnóstico por imagem , Espondilartrite/classificação , Espondilartrite/diagnóstico por imagem , Espondilartrite/genética , Espondilartrite/terapia , Espondilite Anquilosante/diagnóstico por imagemRESUMO
OBJECTIVE: Early identification of patients unlikely to achieve good long-term disease control with anti-tumor necrosis factor therapy in axial spondyloarthritis (SpA) and psoriatic arthritis (PsA) is important for physicians following treat-to-target recommendations. Here we assess associations between disease activity or clinical response during the first 12 weeks of treatment and attainment of treatment targets at week 48 in axial SpA and PsA patients receiving certolizumab pegol. METHODS: The relationship between disease activity or clinical response during the first 12 weeks of treatment and achievement of week-48 targets (for axial SpA: inactive disease based on Ankylosing Spondylitis Disease Activity Score [ASDAS] using the C-reactive protein [CRP] level, or Bath Ankylosing Spondylitis Disease Activity Index <2 with normal CRP level; and for PsA: minimal disease activity) was assessed post hoc using RAPID-axSpA and RAPID-PsA trial data. RESULTS: A clear relationship between disease activity from week 2 to 12 and achievement of week-48 treatment targets was observed in both axial SpA and PsA populations. In axial SpA, week-48 ASDAS inactive disease was achieved by 0% of patients (0 of 21) with ASDAS very high disease activity at week 12, compared to 68% of patients (34 of 50) with week-12 ASDAS inactive disease. For PsA, week-48 minimal disease activity was achieved by 0% of patients (0 of 26) with Disease Activity Score in 28 joints (DAS28) using the CRP level >5.1 at week 12, compared to 73% of patients (57 of 78) with DAS28-CRP <2.6. Similar results were observed regardless of the disease activity measure used. Clinical response at week 12 also predicted week-48 outcomes, though to a lesser extent than disease activity. CONCLUSION: Using disease activity and the clinical response state during the first 12 weeks of certolizumab pegol treatment, it was possible to identify a subset of axial SpA and PsA patients unlikely to achieve long-term treatment goals.
Assuntos
Artrite Psoriásica/diagnóstico , Artrite Psoriásica/tratamento farmacológico , Certolizumab Pegol/administração & dosagem , Progressão da Doença , Espondilartrite/diagnóstico , Espondilartrite/tratamento farmacológico , Proteína C-Reativa , Método Duplo-Cego , Diagnóstico Precoce , Feminino , Humanos , Imunossupressores/administração & dosagem , Masculino , Valor Preditivo dos Testes , Fatores de Tempo , Resultado do TratamentoRESUMO
The clinical course of axial spondyloarthritis (SpA) is variable and characterized by chronic back pain and extraspinal manifestations, such as asymmetrical arthritis, dactylitis and enthesitis. Extra-articular manifestations in the eyes (anterior uveitis), skin (psoriasis) and intestines (chronic inflammatory bowel disease) are also frequent manifestations in patients with SpA. Due to the heterogeneity of disease manifestations and the partial concentration on structural alterations in the sacroiliac joints visible in Xray images, the diagnosis is often delayed for many years. An important step in the direction of improved early recognition of axial SpA was establishment of the Assessment of SpondyloArthritis International Society (ASAS) classification criteria published in 2009, which focused on the initally deep-seated back pain and chronicity in relatively young patients as well as the importance of magnetic resonance imaging and HLA B 27 determination in the early stages of the disease. In order to achieve the foundations for an effective and timely therapy of affected patients, in 2014 on the initiative of the German Society of Rheumatology, S3 guidelines on axial SpA including Bechterew's disease and early forms were formulated in cooperation with other specialist societies. This article gives an overview of the contents of the S3 guidelines on axial SpA.
Assuntos
Dor nas Costas/diagnóstico , Dor nas Costas/terapia , Imageamento por Ressonância Magnética/normas , Guias de Prática Clínica como Assunto , Reumatologia/normas , Espondilartrite/diagnóstico , Espondilartrite/terapia , Dor nas Costas/etiologia , Tomada de Decisão Clínica/métodos , Diagnóstico Diferencial , Medicina Baseada em Evidências/normas , Alemanha , Humanos , Avaliação de Resultados em Cuidados de Saúde/normas , Sociedades Médicas/normas , Espondilartrite/complicações , Resultado do TratamentoRESUMO
The management of patients with spondyloarthritis (SpA) has experienced a paradigm shift in recent years. This is true for the treatment of axial as well as peripheral manifestations. International treat to target (T2T) recommendations for SpA based on the T2T strategy have now also been published, which contain 5 higher level principles (A-E) in addition to the 15 recommendations. In order to make the recommendations known and to promote national distribution, German experts have now issued a translation of the T2T recommendations for SpA into German.
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Avaliação de Resultados em Cuidados de Saúde/normas , Planejamento de Assistência ao Paciente/normas , Assistência Centrada no Paciente/normas , Reumatologia/normas , Espondilartrite/diagnóstico , Espondilartrite/terapia , Tomada de Decisão Clínica , Medicina Baseada em Evidências , Alemanha , Humanos , Guias de Prática Clínica como Assunto , Tradução , Resultado do TratamentoRESUMO
In a joint initiative by the boards of the German Society for Rheumatology (DGRh) and the Association of Rheumatology Clinics (VRA) the European "standards of care" for rheumatoid arthritis, recently suggested by the European Musculoskeletal Conditions Surveillance and Information Network (eumusc.net) and supported by the European League Against Rheumatism (EULAR), were translated and annotated. The recommendations include aspects of the management of the disease, actual medical care, and access to information - this includes all types of support people with RA need, and, last but not least communication of the necessary knowledge. Furthermore, health care structures such as the availability of medical staff with relevant expertise are also important.
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Artrite Reumatoide/diagnóstico , Artrite Reumatoide/terapia , Atenção à Saúde/normas , Guias de Prática Clínica como Assunto , Reumatologia/normas , Europa (Continente) , Medicina Baseada em Evidências , Alemanha , Humanos , Tradução , Resultado do TratamentoRESUMO
Quality measurement of medical care has become increasingly important in Germany in recent years. Essentially, three areas can be distinguished: the quality of structure, process and outcome. For the measurement of quality, quality indicators are necessary. The Federal Joint Committee has recently been responsible for defining such quality indicators. Because proposals for quality indicators for the indication for rheumatoid arthritis in have already been published in international rheumatology, we selected and translated the three most important European publications in order to present them to the rheumatology community. The ultimate aim is the initiation of a process for the joint development of quality indicators within the professional association and the two associations in Germany in order to then be able to adequately discuss these with policy-makers.
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Artrite Reumatoide/diagnóstico , Artrite Reumatoide/terapia , Internacionalidade , Garantia da Qualidade dos Cuidados de Saúde/normas , Indicadores de Qualidade em Assistência à Saúde/normas , Reumatologia/normas , Alemanha , Humanos , Guias de Prática Clínica como AssuntoRESUMO
OBJECTIVE: Axial spondyloarthritis (axial SpA) is characterized by inflammation of the spine and sacroiliac joints and can also affect extraarticular sites, with the most common manifestation being uveitis. Here we report the incidence of uveitis flares in axial SpA patients from the RAPID-axSpA trial, including ankylosing spondylitis (AS) and nonradiographic (nr) axial SpA. METHODS: The RAPID-axSpA (NCT01087762) trial is double-blind and placebo-controlled to week 24, dose-blind to week 48, and open-label to week 204. Patients were randomized to certolizumab pegol (CZP) or placebo. Placebo patients entering the dose-blind phase were re-randomized to CZP. Uveitis events were recorded on extraarticular manifestation or adverse event forms. Events were analyzed in patients with/without history of uveitis, and rates reported per 100 patient-years. RESULTS: At baseline, 38 of 218 CZP-randomized patients (17.4%) and 31 of 107 placebo-randomized patients (29.0%) had past uveitis history. During the 24-week double-blind phase, the rate of uveitis flares was lower in CZP (3.0 [95% confidence interval (95% CI) 0.6-8.8] per 100 patient-years) than in placebo (10.3 [95% CI 2.8-26.3] per 100 patient-years). All cases observed during the 24-week double-blind phase were in patients with a history of uveitis; in these patients, rates were similarly lower for CZP (17.1 [95% CI 3.5-50.1] per 100 patient-years) than placebo (38.5 [95% CI 10.5-98.5] per 100 patient-years). Rates of uveitis flares remained low up to week 96 (4.9 [95% CI 3.2-7.4] per 100 patient-years) and were similar between AS (4.4 [95% CI 2.3-7.7] per 100 patient-years) and nr-axial SpA (5.6 [95% CI 2.9-9.8] per 100 patient-years). CONCLUSION: The rate of uveitis flares was lower for axial SpA patients treated with CZP than placebo during the randomized controlled phase. Incidence of uveitis flares remained low to week 96 and was comparable to rates reported for AS patients receiving other anti-tumor necrosis factor antibodies.
Assuntos
Certolizumab Pegol/uso terapêutico , Imunossupressores/uso terapêutico , Espondilartrite/tratamento farmacológico , Uveíte/epidemiologia , Adulto , Método Duplo-Cego , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-IdadeRESUMO
A taskforce comprised of an expert group of 21 rheumatologists, radiologists and methodologists from 11 countries developed evidence-based recommendations on the use of imaging in the clinical management of both axial and peripheral spondyloarthritis (SpA). Twelve key questions on the role of imaging in SpA were generated using a process of discussion and consensus. Imaging modalities included conventional radiography, ultrasound, magnetic resonance imaging, computed tomography (CT), positron emission tomography, single photon emission CT, dual-emission x-ray absorptiometry and scintigraphy. Experts applied research evidence obtained from systematic literature reviews using MEDLINE and EMBASE to develop a set of 10 recommendations. The strength of recommendations (SOR) was assessed by taskforce members using a visual analogue scale. A total of 7550 references were identified in the search process, from which 158 studies were included in the systematic review. Ten recommendations were produced using research-based evidence and expert opinion encompassing the role of imaging in making a diagnosis of axial SpA or peripheral SpA, monitoring inflammation and damage, predicting outcome, response to treatment, and detecting spinal fractures and osteoporosis. The SOR for each recommendation was generally very high (range 8.9-9.5). These are the first recommendations which encompass the entire spectrum of SpA and evaluate the full role of all commonly used imaging modalities. We aimed to produce recommendations that are practical and valuable in daily practice for rheumatologists, radiologists and general practitioners.
Assuntos
Diagnóstico por Imagem/métodos , Espondilartrite/diagnóstico , Espondilartrite/terapia , Europa (Continente) , Humanos , Imageamento por Ressonância Magnética , Tomografia por Emissão de Pósitrons , Radiografia , Espondilartrite/classificação , Tomografia Computadorizada por Raios X , Resultado do Tratamento , UltrassonografiaRESUMO
OBJECTIVE: Previous reports of the RAPID-axSpA trial (NCT01087762) described the efficacy and safety of certolizumab pegol (CZP) over 24 weeks in patients with axial spondyloarthritis (SpA), including ankylosing spondylitis (AS) and nonradiographic axial SpA. We report efficacy and safety data up to week 96 of the study. METHODS: The RAPID-axSpA trial is double-blind and placebo-controlled to week 24, dose-blind to week 48, and open-label to week 204. Outcome variables included Assessment of SpondyloArthritis international Society criteria for 20% and 40% improvement in disease activity (ASAS20/40), ASAS partial remission responses (analyzed by nonresponder imputation), AS Disease Activity Score (ASDAS), ASDAS inactive disease, ASDAS major improvement, Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), and Bath AS Metrology Index (BASMI) linear score (analyzed by the last observation carried forward method). Safety data were collected for patients treated with ≥1 dose of CZP. RESULTS: Of the 325 patients who were randomized, 218 received CZP from week 0. Of these, 93% completed week 24, 88% completed week 48, and 80% completed week 96. Improvements in ASAS responses were maintained to week 96 (for ASAS20, 67.4%, 72.0%, and 62.8% at weeks 24, 48, and 96, respectively), as well as improvements in ASDAS, BASDAI (mean score 3.3, 3.1, and 3.0 at weeks 24, 48, and 96, respectively), BASFI, and BASMI linear score. Comparable improvements were observed with both dosing regimens (200 mg every 2 weeks or 400 mg every 4 weeks) and in patients with AS and those with nonradiographic axial SpA. In the safety set, adverse events occurred in 279 patients (88.6%) and serious adverse events in 41 (13.0%). No deaths or malignancies were reported. CONCLUSION: Clinical improvements to week 24 in both CZP dosing regimens were sustained to week 96. Similar sustained improvements were observed in AS and nonradiographic axial SpA subpopulations. The safety profile was consistent with previous reports from RAPID-axSpA, with no new safety signals observed with longer exposure.