RESUMO
In pharmacoepidemiology, robust data are needed to judge the impact of drug treatment on pregnancy, pregnancy outcomes and breast-fed infants. As pregnant and breastfeeding women are usually excluded from randomised clinical trials, observational studies are required. One of those data sources are pregnancy registers specifically developed to focus on certain diseases or disease groups. The German Rhekiss register investigates pregnancies in women with chronic inflammatory rheumatic diseases (IRD). Rhekiss is a nationwide, multicentre, longitudinal study, in which women aged 18 years or older with an underlying IRD can be enrolled by a rheumatologist either when planning a pregnancy or in the first half of pregnancy. Data are collected prospectively at regular follow-up visits. Rheumatologists and patients provide information in a web-based system before conception (if enrolment was at the time of pregnancy planning), during and after pregnancy. A smartphone app is available for patients. Maternal and clinical information, general laboratory markers, treatment with antirheumatic and other drugs, adverse events, items related to course and outcome of pregnancy and the health of the child are uniformly assessed for all diseases. Individual information on the IRD includes classification criteria, diagnosis-specific laboratory parameters, clinical parameters and validated instruments to measure disease activity or damage. Furthermore, patient-reported outcome measures are captured. A total of 2013 individual patients have been enrolled in the register, and data on 1801 completed pregnancies are available. In summary, Rhekiss is a comprehensive and complex register that can answer various research questions about pregnancy in women with chronic IRDs.
Assuntos
Antirreumáticos , Complicações na Gravidez , Resultado da Gravidez , Sistema de Registros , Doenças Reumáticas , Humanos , Gravidez , Feminino , Doenças Reumáticas/tratamento farmacológico , Doenças Reumáticas/epidemiologia , Alemanha/epidemiologia , Complicações na Gravidez/epidemiologia , Complicações na Gravidez/tratamento farmacológico , Resultado da Gravidez/epidemiologia , Antirreumáticos/uso terapêutico , Antirreumáticos/efeitos adversos , Estudos Longitudinais , Adulto , Farmacoepidemiologia/métodos , Adolescente , Adulto JovemRESUMO
OBJECTIVE: To compare event and incidence rates of herpes zoster (HZ), also known as shingles, in patients with rheumatoid arthritis under treatment with conventional synthetic (cs), targeted synthetic (ts) or biologic (b) disease-modifying antirheumatic drugs (DMARDs). METHODS: Patients were prospectively enrolled from 2007 until October 2020. Reported HZ events were assigned to ongoing treatments or those terminated within 1 month prior to the HZ event. Exposure-adjusted event rates (EAERs) of HZ were calculated per 1000 patient years (py) and adjusted HRs with 95% CIs computed. Inverse probability weights (IPW) were used to adjust for confounding by indication. RESULTS: Data of 13 991 patients (62 958 py) were analysed, with 559 HZ events reported in 533 patients. The EAER of HZ was highest for tsDMARDs (21.5, 95% CI 16.4 to 27.9), followed by B cell targeted therapy (10.3, 95% CI 8.0 to 13.0), monoclonal antitumour necrosis factor (anti-TNF) antibodies (9.3, 95% CI 7.7 to 11.2), interleukin 6 inhibitors (8.8, 95% CI 6.9 to 11.0), soluble TNF receptor fusion protein (8.6, 95% CI 6.8 to 10.8), T cell costimulation modulator (8.4, 95% CI 5.9 to 11.8) and csDMARDs (7.1, 95% CI 6.0 to 8.3). Adjusted for age, sex and glucocorticoids and weighted with IPW, tsDMARDs (HR 3.66, 95% CI 2.38 to 5.63), monoclonal anti-TNF antibodies (HR 1.63, 95% CI 1.17 to 2.28) and B cell targeted therapy (HR 1.57, 95% CI 1.03 to 2.40) showed a significantly higher risk compared with csDMARDs. CONCLUSION: Our results provide evidence for a 3.6-fold increased risk of HZ associated with tsDMARDs and an increased risk of HZ under bDMARDs compared with csDMARDs.
Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Herpes Zoster/epidemiologia , Inibidores de Janus Quinases/uso terapêutico , Adulto , Idoso , Feminino , Humanos , Incidência , Interleucina-6/antagonistas & inibidores , Masculino , Pessoa de Meia-Idade , Terapia de Alvo Molecular , Sistema de Registros , Fatores de Risco , Fator de Necrose Tumoral alfa/antagonistas & inibidoresRESUMO
OBJECTIVE: To develop evidence-based European Alliance of Associations for Rheumatology (EULAR) points to consider (PtCs) for the management of difficult-to-treat rheumatoid arthritis (D2T RA). METHODS: An EULAR Task Force was established comprising 34 individuals: 26 rheumatologists, patient partners and rheumatology experienced health professionals. Two systematic literature reviews addressed clinical questions around diagnostic challenges, and pharmacological and non-pharmacological therapeutic strategies in D2T RA. PtCs were formulated based on the identified evidence and expert opinion. Strength of recommendations (SoR, scale A-D: A typically consistent level 1 studies and D level 5 evidence or inconsistent studies) and level of agreement (LoA, scale 0-10: 0 completely disagree and 10 completely agree) of the PtCs were determined by the Task Force members. RESULTS: Two overarching principles and 11 PtCs were defined concerning diagnostic confirmation of RA, evaluation of inflammatory disease activity, pharmacological and non-pharmacological interventions, treatment adherence, functional disability, pain, fatigue, goal setting and self-efficacy and the impact of comorbidities. The SoR varied from level C to level D. The mean LoA with the overarching principles and PtCs was generally high (8.4-9.6). CONCLUSIONS: These PtCs for D2T RA can serve as a clinical roadmap to support healthcare professionals and patients to deliver holistic management and more personalised pharmacological and non-pharmacological therapeutic strategies. High-quality evidence was scarce. A research agenda was created to guide future research.
Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Antirreumáticos/administração & dosagem , Artrite Reumatoide/complicações , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/terapia , Terapia Cognitivo-Comportamental , Comorbidade , Exercício Físico , Hepatite B/complicações , Hepatite B/tratamento farmacológico , Hepatite C/complicações , Hepatite C/tratamento farmacológico , Humanos , Adesão à Medicação , Educação de Pacientes como Assunto , Avaliação de SintomasRESUMO
OBJECTIVE: To investigate the frequency of outpatient physical therapy (PT) in persons with rheumatoid arthritis (RA), axial spondylarthritis (axSpA), psoriatic arthritis (PsA) or systemic lupus erythematosus (SLE) between 2005 and 2020. METHODS: Adult insured persons of the BARMER health insurance fund with a diagnosis of RA (ICD-10: M05, M06), axSpA (M45), PsA (M07.0-3) or SLE (M32.1,8,9) were included. The prescription of PT was identified via the national item number index for therapeutic products. The proportion of persons with at least 1 prescription in the years 2005 to 2020 is reported as well as PT prescriptions by age and gender groups. In addition, the number and duration of prescriptions were compared and it was analyzed whether persons in specialist care received PT more frequently. RESULTS: In 2020, 43% (SLE), 46% (RA, PsA) and 49% (axSpA) received at least 1 PT prescription. Physiotherapy was prescribed most frequently (37%), followed by manual therapy (14%) and thermotherapy (10%). Since 2005 the number of insured persons receiving PT has not changed. Manual therapy is increasingly prescribed (+7%), while massage (-10%), thermotherapy (-7%) and electrotherapy (3% in 2005, 2% in 2020) have been decreasing (data relating to RA). The number of prescriptions has not relevantly changed since 2010. Persons in orthopedic care received PT more frequently than persons in general or rheumatological care. Female patients 61-80 years old were most frequently treated with PT. CONCLUSION: Slightly less than half of all persons with an RA, axSpA, PsA or SLE diagnosis received outpatient PT. This proportion has hardly changed in the last 15 years.
Assuntos
Artrite Psoriásica , Artrite Reumatoide , Lúpus Eritematoso Sistêmico , Febre Reumática , Adulto , Idoso , Idoso de 80 Anos ou mais , Artrite Psoriásica/diagnóstico , Artrite Psoriásica/epidemiologia , Artrite Psoriásica/terapia , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/epidemiologia , Artrite Reumatoide/terapia , Feminino , Humanos , Pessoa de Meia-Idade , Modalidades de Fisioterapia , PrescriçõesRESUMO
The scientific focus of the DRFZ's Programme Area Epidemiology and Health Services Research is, on the one hand, investigating the health care situation of people with rheumatic diseases in Germany, including its deficits, progress and trends. On the other hand, an essential goal is to uncover risk factors for unfavourable disease trajectories, but also protective factors, through the long-term observation of disease courses in large cohorts. With the approval of innovative, targeted therapies at the beginning of this millennium, the question of the real-world safety and effectiveness of the various anti-rheumatic therapies became a key issue for doctors and patients. The biologics registers have developed into central instruments of the programme area, which enable questions on comparative drug safety, but also on therapy effectiveness and risk reduction through effective therapy, to be answered in a robust manner.In this article, selected results of epidemiological research at the DRFZ are presented. The overall goal of the research was and is to contribute to improving the quality of life of children and adults with rheumatic and musculoskeletal diseases. This is the purpose of clinical-evaluative health services research as well as the acquisition of knowledge that supports effective, individualised therapy. Large, long-term patient cohorts and a stable network with clinical rheumatologists and those affected have proven to be indispensable instruments.
Assuntos
Produtos Biológicos , Doenças Reumáticas , Adulto , Produtos Biológicos/uso terapêutico , Criança , Alemanha/epidemiologia , Pesquisa sobre Serviços de Saúde , Humanos , Qualidade de Vida , Doenças Reumáticas/tratamento farmacológico , Doenças Reumáticas/terapiaRESUMO
BACKGROUND AND OBJECTIVE: There is an urgent need for robust data on the trajectories and outcomes of pregnancies in women with inflammatory rheumatic diseases (IRD). In particular when rare outcomes or rare diseases are to be investigated, collaborative approaches are required. However, joint data analyses are often limited by the heterogeneity of the different data sources.To facilitate future research collaboration, a European League Against Rheumatism (EULAR) Task Force defined a core data set with a minimum of items to be collected by pregnancy registries in rheumatology covering the period of pregnancy and the 28-day neonatal phase in women with any underlying IRD. METHODS: A stepwise process included a two-round Delphi survey and a face-to-face meeting to achieve consensus about relevant items. RESULTS: A total of 64 multidisciplinary stakeholders from 14 different countries participated in the two rounds of the Delphi process. During the following face-to-face meeting of the EULAR Task Force, consensus was reached on 51 main items covering 'maternal information', 'pregnancy' and 'treatment'. Generic instruments for assessment are recommended for every item. Furthermore, for the five most frequent IRDs rheumatoid arthritis, spondyloarthritis, juvenile idiopathic arthritis, systemic lupus erythematosus and other connective tissue diseases, disease-specific laboratory markers and disease activity measurements are proposed. CONCLUSION: This is the first consensus-based core data set for prospective pregnancy registries in rheumatology. Its purpose is to stimulate and facilitate multinational collaborations that aim to increase the knowledge about pregnancy course and safety of treatment in women with IRDs during pregnancy.
Assuntos
Antirreumáticos/uso terapêutico , Coleta de Dados , Complicações na Gravidez/terapia , Resultado da Gravidez , Sistema de Registros , Doenças Reumáticas/terapia , Comitês Consultivos , Artrite Juvenil/fisiopatologia , Artrite Juvenil/terapia , Artrite Reumatoide/fisiopatologia , Artrite Reumatoide/terapia , Doenças do Tecido Conjuntivo/fisiopatologia , Doenças do Tecido Conjuntivo/terapia , Técnica Delphi , Europa (Continente) , Feminino , Humanos , Lúpus Eritematoso Sistêmico/fisiopatologia , Lúpus Eritematoso Sistêmico/terapia , Cuidado Pós-Natal , Cuidado Pré-Concepcional , Gravidez , Complicações na Gravidez/fisiopatologia , Doenças Reumáticas/fisiopatologia , Reumatologia , Índice de Gravidade de Doença , Espondiloartropatias/fisiopatologia , Espondiloartropatias/terapiaRESUMO
BACKGROUND: Despite treatment according to the current management recommendations, a significant proportion of patients with rheumatoid arthritis (RA) remain symptomatic. These patients can be considered to have 'difficult-to-treat RA'. However, uniform terminology and an appropriate definition are lacking. OBJECTIVE: The Task Force in charge of the "Development of EULAR recommendations for the comprehensive management of difficult-to-treat rheumatoid arthritis" aims to create recommendations for this underserved patient group. Herein, we present the definition of difficult-to-treat RA, as the first step. METHODS: The Steering Committee drafted a definition with suggested terminology based on an international survey among rheumatologists. This was discussed and amended by the Task Force, including rheumatologists, nurses, health professionals and patients, at a face-to-face meeting until sufficient agreement was reached (assessed through voting). RESULTS: The following three criteria were agreed by all Task Force members as mandatory elements of the definition of difficult-to-treat RA: (1) Treatment according to European League Against Rheumatism (EULAR) recommendation and failure of ≥2 biological disease-modifying antirheumatic drugs (DMARDs)/targeted synthetic DMARDs (with different mechanisms of action) after failing conventional synthetic DMARD therapy (unless contraindicated); (2) presence of at least one of the following: at least moderate disease activity; signs and/or symptoms suggestive of active disease; inability to taper glucocorticoid treatment; rapid radiographic progression; RA symptoms that are causing a reduction in quality of life; and (3) the management of signs and/or symptoms is perceived as problematic by the rheumatologist and/or the patient. CONCLUSIONS: The proposed EULAR definition for difficult-to-treat RA can be used in clinical practice, clinical trials and can form a basis for future research.
Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Glucocorticoides/uso terapêutico , Comitês Consultivos , Artrite Reumatoide/diagnóstico por imagem , Artrite Reumatoide/fisiopatologia , Progressão da Doença , Resistência a Medicamentos , Quimioterapia Combinada , Europa (Continente) , Humanos , Guias de Prática Clínica como Assunto , Reumatologia , Participação dos Interessados , Terminologia como Assunto , Falha de TratamentoRESUMO
OBJECTIVES: The effectiveness of TNF inhibitors in RA has been shown to be affected by obesity. No such effect has been found for abatacept and rituximab, while for tocilizumab results are ambiguous. Additionally, it remains unresolved whether sex is an effect modifier for obesity. We investigated the impact of obesity on the drug effectiveness of conventional synthetic or biologic DMARDs, taking into account potential sex-specific differences. METHODS: Data from 10 593 RA patients included in the German observational cohort study Rheumatoid Arthritis: oBservation of BIologic Therapy (RABBIT) since 2009 were analysed. Patients had to have a BMI ≥18.5 kg/m2, at least one follow-up and 6 months of observation time. The influence of obesity on drug effectiveness was investigated by regression analysis, adjusting for potential confounders. RESULTS: Obesity had a negative impact on improvement in the DAS with 28 joints using ESR as an inflammation marker of -0.15 (95% CI: -0.26; -0.04) units for women receiving conventional synthetic DMARDs, -0.22 (95% CI: -0.31; -0.12) units for women receiving TNF inhibitors, -0.22 (95% CI: -0.42; -0.03) units for women receiving tocilizumab and -0.41 (95% CI: -0.74; -0.07) units for men receiving tocilizumab. Overall, no negative obesity effects on the effectiveness of rituximab and abatacept were found. CONCLUSION: Obesity has a negative impact on the effectiveness of cytokine-targeted but not cell-targeted therapies in daily practice, affecting more outcomes and therapies in women than in men. Overall, no effects of obesity on treatment effectiveness were found for rituximab and abatacept.
Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Obesidade/complicações , Inibidores do Fator de Necrose Tumoral/uso terapêutico , Abatacepte/administração & dosagem , Abatacepte/uso terapêutico , Adulto , Idoso , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/uso terapêutico , Antirreumáticos/administração & dosagem , Artrite Reumatoide/complicações , Produtos Biológicos/administração & dosagem , Relação Dose-Resposta a Droga , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Rituximab/administração & dosagem , Rituximab/uso terapêutico , Resultado do Tratamento , Inibidores do Fator de Necrose Tumoral/administração & dosagemRESUMO
OBJECTIVES: To investigate the courses and outcomes of pregnancies involving JIA patients who were exposed to DMARDs. METHODS: In the Juvenile arthritis MTX/Biologics long-term Observation study, pregnant patients or male patients with pregnant partners were identified. Standardized patient interviews were conducted, and the course and outcome of pregnancy were assessed. Prospectively collected physician- and patient-reported data were also considered in the analysis. RESULTS: The study sample included 152 pregnancies in 98 women with JIA and 39 pregnancies involving 21 male patients as partners. The majority of patients had polyarticular-onset/-course JIA (61%). The average age of patients at first pregnancy was 24.1 (4.5) years, and their mean disease duration was 13.8 (5.9) years. Patients had been exposed to DMARDs for 9.5 (5.6) years, and 90% of these patients had received biologics before. Half of the pregnancies occurred during DMARD exposure, mostly with etanercept. Significant differences in pregnancy outcomes between DMARD-exposed and -unexposed pregnancies were not observed. Spontaneous abortion (13.1%) and congenital anomaly (3.6%) rates were not suggestive of increased risk compared with expected background rates. However, the rates of premature birth (12.3%) and caesarean section (37.7%) were slightly above those in the German birthing population. The disease activity of female patients remained relatively stable in pregnancy, with mean cJADAS-10 scores of 5.3, 7.1 and 5.6 in each trimester, respectively. CONCLUSION: Young adults with JIA often become pregnant or become fathers of children while still being treated with DMARDs. Data suggest no increased risk of major adverse pregnancy outcomes.
Assuntos
Antirreumáticos/uso terapêutico , Artrite Juvenil/tratamento farmacológico , Exposição Materna , Exposição Paterna , Resultado da Gravidez , Adalimumab/uso terapêutico , Adulto , Produtos Biológicos/uso terapêutico , Etanercepte/uso terapêutico , Feminino , Humanos , Masculino , Metotrexato/uso terapêutico , Gravidez , Sistema de Registros , Adulto JovemRESUMO
OBJECTIVES: To capture comorbidity and medication of persons with Sjögren's syndrome (SS) in a population-based cohort in comparison to matched controls. METHODS: Individuals with an outpatient diagnosis of M35.0 (ICD-10) in ≥2 quarters of a year or an inpatient diagnosis of M35.0 were identified in a German statutory health insurance fund covering 7.2 million people. Persons in rheumatologic care were grouped by incident or prevalent diagnosis and by co-existing autoimmune disease (sSS) or primary (p)SS and compared to age- and sex-matched controls regarding comorbidity (ICD-10), medical prescriptions, hospitalisation and inability to work in the previous year. RESULTS: In 2018, 7,283 persons (0.10%) had incident and 54,273 persons (0.75%) prevalent SS diagnosis, and 5,961 (11%) were in rheumatologic care. Of these (90% female, mean age 66 years), 3,457 (58%) had further autoimmune disease (sSS), mostly rheumatoid arthritis (80%) and systemic lupus erythematosus (13%). Compared to controls, frequent comorbid conditions in SS were hypertension (controls: 52%, pSS: 55%, sSS: 63%), osteoarthritis (22%/40%/47%), osteoporosis (10%/26%/38%) and depression (21%/34%/36%). Systemic antirheumatic drugs were prescribed in 31% (pSS) and 66% (sSS) while < 5% received topical therapies. Glucocorticoids (8%/34%/59%), NSAIDs (28%/41%/45%), opioids (8%/15%/21%), analgesics (19%/30%/36%) and antidepressants (14%/21%/21%) were frequently prescribed. Compared to controls, hospitalisation (21%/32%/39%) and inability to work in persons <65 years (41%/48%/44%, median days 17/24/30) were more frequent in pSS and sSS than in controls. CONCLUSIONS: SS claims diagnosis is associated with substantial comorbidity and frequent prescription of anti-inflammatory drugs, analgesics and antidepressants. The individual and societal burden of SS shows that, in addition to effective treatment strategies, intensive attention to comorbidities is important in this disease.
Assuntos
Artrite Reumatoide , Doenças Autoimunes , Síndrome de Sjogren , Idoso , Comorbidade , Análise de Dados , Feminino , Humanos , Masculino , Síndrome de Sjogren/diagnóstico , Síndrome de Sjogren/tratamento farmacológico , Síndrome de Sjogren/epidemiologiaRESUMO
The original article can be found online.
RESUMO
Osteoporosis is a frequent comorbidity in rheumatoid arthritis (RA). Due to the improved treatment options for RA, we expect a long-term decrease in osteoporosis as an accompanying disease. Data from the German National Database (NDB) were used to investigate whether the frequency of osteoporosis has changed in the last 10 years. From 2007 to 2017, approximately 4000 patients were documented annually with data on therapy and comorbidity. The cross-sectional data were summarised descriptively. Age, sex, disease duration, disease activity and glucocorticoids were considered as influencing factors. The Cochrane-Armitage test for trend was used to test whether the frequency of osteoporosis at the first visit changed from 2007 to 2017. Osteoporosis frequency in RA patients (mean age 63 years, 75% female) decreased from 20% in 2007 to 6% in 2017 (p < 0.001). The decrease affected women (22% to 17%) and men (14% to 8%) in all age groups and both short-term (≤ 2-year disease duration: 9% to 3%) and long-term RA patients (> 10-year disease duration: 28% to 20%). Patients with high disease activity and patients who took glucocorticoids (GC) were more often affected by osteoporosis than patients in remission or without GC. Drug prophylaxis in patients without osteoporosis increased (20% to 41% without GC, 48% to 55% with GC). Men with GC received less prophylactic treatment than women (48% vs. 57% in 2017). In this cohort, osteoporosis in patients with RA is less frequently observed compared to former years. RA-specific risk factors for osteoporosis such as disease activity and GC therapy have declined but long-term GC use is still present. Assessment of osteoporosis in RA patients should be investigated more consistently by bone density measurement. Male RA patients still need to be given greater consideration regarding osteoporosis drug prophylaxis, especially when GC therapy is needed.
Assuntos
Artrite Reumatoide/epidemiologia , Osteoporose/epidemiologia , Adulto , Idoso , Artrite Reumatoide/tratamento farmacológico , Comorbidade , Estudos Transversais , Bases de Dados Factuais , Progressão da Doença , Feminino , Alemanha/epidemiologia , Glucocorticoides/administração & dosagem , Glucocorticoides/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , PrevalênciaRESUMO
OBJECTIVE: To describe trends in outcomes among patients with idiopathic inflammatory myopathies (IIM) over two decades. METHODS: From 1997 to 2017, a total of 1079 IIM patients were documented in the National Database of the German Collaborative Arthritis Centers. Annual cross-sectional data on treatment, disease activity, patient-reported outcomes, hospitalization and employment were compared across the years. Information on phenotypes, organ manifestations and autoantibodies was collected for a subset to compare the assessment of global health, pain, fatigue and sleeping disorders. RESULTS: In 2017, significantly more IIM patients were assessed to be in low disease activity (94%) than in 1997 (59%), p < 0.01. Pain (p = 0.001), global health (p = 0.049), fatigue (p = 0.03) and sleeping disorders (p = 0.01) also improved since recording. Glucocorticoid use decreased from 84 to 58% (p < 0.01). Employment in patients < 65 years remained unchanged (53%), while early retirement (23-9%), hospitalization/year (34-18%) and sick leave (52-24%) decreased. A total of 186 patients with information on subtypes were classified as polymyositis (44%), dermatomyositis (33%), anti-synthetase syndrome (10%), overlapping-myositis (8%), inclusion body myositis (2%), necrotizing myositis (0.5%) and unspecific (3%). The most frequently reported symptoms were limitations in global health (60%), fatigue (57%) and sleeping disorders (51%), and all of them were most frequent in overlap-myositis. Pulmonary hypertension and cardiomyopathy were associated with poor outcomes regarding global health, daily activities and fatigue. CONCLUSION: IIM patients report better outcomes than 20 years ago, along with good physician-reported disease control. Global health, fatigue and sleeping disorders are relevant patient-reported domains in IIM.
Assuntos
Fadiga/epidemiologia , Miosite/epidemiologia , Medidas de Resultados Relatados pelo Paciente , Transtornos do Sono-Vigília/epidemiologia , Estudos Transversais , Bases de Dados Factuais , Fadiga/etiologia , Feminino , Alemanha/epidemiologia , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Miosite/classificação , Medição da Dor/estatística & dados numéricos , Índice de Gravidade de Doença , Transtornos do Sono-Vigília/etiologiaRESUMO
BACKGROUND: A great heterogeneity in total joint replacement (TJR) rates has been reported for osteoarthritis (OA), most likely arising from a gap between patients' and physicians' views on the need for TJR. The purpose of this study therefore was to analyze potential cofactors which might influence the desire of patients to undergo TJR and physicians' willingness to discuss surgery with their patients. METHODS: A total of 8995 patients in Germany with a claims data diagnosis of hip or knee OA or polyarthrosis were asked to complete a questionnaire for this cross-sectional study of sociodemographic factors, indicators of current joint function (WOMAC score), willingness to undergo TJR and whether they had already discussed TJR with a physician. The overall response rate was 40%. Responders with polyarthrosis and individuals without current or chronic symptoms in the corresponding joints, pain in already replaced joints or simultaneous symptomatic hip and knee OA were excluded. We linked the survey results to claims data. Separate logistic regression models were used to assess which parameters were associated with patients' willingness to undergo TJR and physicians' discussion of surgery. RESULTS: We analyzed 478 hip OA and 932 knee OA patients. Just 17% with hip OA and 14% with knee OA were willing to undergo TJR, although 44 and 45% had already discussed surgery with their physicians. Patients' willingness was associated with higher WOMAC scores, a deterioration of symptoms over the last 2 years, and previous TJR for another joint. The discussion with a physician was influenced by the impact on personal life and previous arthroplasty. Older age (odds Ratio (OR) 1.2 per 10 years), male sex (OR 0.69 vs female), longer symptom duration (OR 1.08 per 5 years), deterioration of symptoms (OR 2.0 vs no change/improvement), a higher WOMAC score (OR 1.3 per 10% deterioration) and reduced well-being (OR 1.1 per 10% deterioration) were associated with physician discussion in knee OA patients. CONCLUSIONS: The proportion of patients willing to undergo TJR is lower than the proportion in whom physicians discuss surgery. While previous TJR seems to enhance patients' and surgeons' willingness, the influence of other cofactors is heterogeneous.
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Artroplastia de Quadril/estatística & dados numéricos , Artroplastia do Joelho/estatística & dados numéricos , Osteoartrite do Quadril/cirurgia , Osteoartrite do Joelho/cirurgia , Preferência do Paciente/psicologia , Idoso , Estudos Transversais , Tomada de Decisões , Feminino , Alemanha , Necessidades e Demandas de Serviços de Saúde , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Quadril/diagnóstico , Osteoartrite do Joelho/diagnóstico , Índice de Gravidade de Doença , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Musculoskeletal diseases and symptoms are very common in the general population. They lead to high healthcare costs and pose a significant burden to the national economy. OBJECTIVES: Based on data from the population-based German National Cohort (GNC), frequencies of musculoskeletal symptoms and diseases are reported, including back pain, osteoporosis, osteoarthritis, and arthritis. MATERIALS AND METHODS: Data were collected from March 2014 to March 2017 in adults aged 20-75 years during the first half of the baseline survey of the GNC. The sample comprised 101,779 interviewed subjects, including 9370 subjects who underwent clinical musculoskeletal examinations. The interview included questions about specific musculoskeletal disorders. A clinical examination of the hand provided information about palpable swollen joints and pressure-sensitive joints. Resting pain of the knees and hips was also assessed by a clinical examination. Frequencies were standardized to the German standard population of the year 2011. RESULTS: Having ever been diagnosed with recurrent back pain (22.5%) or osteoarthritis (20.6%) were the most common complaints reported in the interview; osteoporosis (2.9%) and rheumatoid arthritis (1.9%) were stated more seldom. According to the hand examination, 6.0% of all participants experienced pain in at least one finger joint. Resting pain was present in at least one knee among 8.2% and in at least one hip among 5.1% of the participants as assessed during the clinical examination. Women were more likely to report musculoskeletal disorders and symptoms than men. The proportion of adults affected by musculoskeletal diseases increased strongly with age. CONCLUSION: Musculoskeletal disorders and symptoms occur frequently. The burden of complaints and diagnoses is comparable to previous population-based surveys.
Assuntos
Doenças Musculoesqueléticas/epidemiologia , Adulto , Idoso , Dor nas Costas/epidemiologia , Feminino , Alemanha/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite/epidemiologia , Prevalência , Inquéritos e Questionários , Adulto JovemRESUMO
OBJECTIVES: To describe and explore differences in formal regulations around sick leave and work disability (WD) for patients with rheumatoid arthritis (RA), as well as perceptions by rheumatologists and patients on the system's performance, across European countries. METHODS: We conducted three cross-sectional surveys in 50 European countries: one on work (re-)integration and social security (SS) system arrangements in case of sick leave and long-term WD due to RA (one rheumatologist per country), and two among approximately 15 rheumatologists and 15 patients per country on perceptions regarding SS arrangements on work participation. Differences in regulations and perceptions were compared across categories defined by gross domestic product (GDP), type of social welfare regime, European Union (EU) membership and country RA WD rates. RESULTS: Forty-four (88%) countries provided data on regulations, 33 (75%) on perceptions of rheumatologists (n=539) and 34 (77%) on perceptions of patients (n=719). While large variation was observed across all regulations across countries, no relationship was found between most of regulations or income compensation and GDP, type of SS system or rates of WD. Regarding perceptions, rheumatologists in high GDP and EU-member countries felt less confident in their role in the decision process towards WD (ß=-0.5 (95% CI -0.9 to -0.2) and ß=-0.5 (95% CI -1.0 to -0.1), respectively). The Scandinavian and Bismarckian system scored best on patients' and rheumatologists' perceptions of regulations and system performance. CONCLUSIONS: There is large heterogeneity in rules and regulations of SS systems across Europe in relation to WD of patients with RA, and it cannot be explained by existing welfare regimes, EU membership or country's wealth.
Assuntos
Artrite Reumatoide/economia , Seguro por Deficiência/legislação & jurisprudência , Saúde Ocupacional/legislação & jurisprudência , Reumatologistas/estatística & dados numéricos , Licença Médica/legislação & jurisprudência , Adulto , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação da Capacidade de Trabalho , Adulto JovemRESUMO
OBJECTIVES: The objective of this study was to assess the current diagnostic delay in axial SpA (axSpA) and to analyse factors associated with it. METHODS: A stratified sample of subjects with a diagnosis of axSpA (International Classification of Diseases, 10th Revision code M45) was drawn from health insurance data in Germany and was questioned on disease-related, lifestyle and socio-economic characteristics. The diagnostic delay was calculated as the time from back pain onset until a diagnosis of axSpA. A multivariable linear regression analysis was performed to explore factors associated with the diagnostic delay. RESULTS: Among 1677 patients with axSpA included in the analysis, the mean diagnostic delay was 5.7 years (median 2.3). Of those, 407 patients were diagnosed in 1996-2005 and 484 patients in 2006-2015. The mean diagnostic delay was not substantially different in both periods: 6.3 years (median 2.6) and 7.4 (2.7), respectively. Multivariable linear regression revealed that female sex [ß = 1.85 (95% CI 1.06, 2.65)], negative HLA-B27 status [ß = 3.61 (95% CI 2.07, 5.14)], presence of psoriasis [ß = 1.40 (95% CI 0.08, 2.73)] and younger age at symptom onset [ß = 1.91 (95% CI 1.53, 2.29)] were factors associated with a longer diagnostic delay. CONCLUSION: The diagnostic delay in axSpA is still unacceptably long. Patients who are female, young at symptom onset, HLA-B27 negative or have psoriasis have a longer diagnostic delay. Specific referral strategies might be necessary in order to decrease the diagnostic delay in patients presenting with these characteristics.
Assuntos
Espondilartrite/diagnóstico , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Dor nas Costas/etiologia , Criança , Diagnóstico Tardio , Escolaridade , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Fatores de Risco , Fatores Sexuais , Espondilartrite/complicações , Espondilite Anquilosante/complicações , Espondilite Anquilosante/diagnóstico , Fatores de Tempo , Adulto JovemRESUMO
OBJECTIVES: To assess trends in treatments and outcomes in patients with primary Sjögren's syndrome (pSS), focusing on employment, hospitalisation and medical treatment in the past two decades. METHODS: From 1996 to 2016, approximately 300 patients with pSS were annually documented in the National Database of the German Collaborative Arthritis Centres. Data on treatment, physicians' assessments of disease activity, patient-reported outcomes, hospitalisation and employment were collected and compared to patients with rheumatoid arthritis (RA), matched 1:1 for age, sex and disease duration for each calendar year. RESULTS: Patients with pSS (>90% female, age 44 years at disease onset, disease duration 10 years) were more frequently assessed to be in low disease activity in 2016 (93%) than in 1996 (62%), p<0.01. Treatment with antimalarials increased from 1996 to 2016 (31 to 50%, p<0.01) and less patients were on glucocorticosteroids (50 to 34%, p<0.01) but <5% were treated with biologics. Employment (<65 years) increased by 21 percentage points (43 to 64%, p<0.001), exceeding the increase observed for RA patients (+15 percentage points). Early retirement (22 to 10%, p=0.01), hospitalisation/year (13 to 7%, p=0.08) and sick leave (39% in 1997 to 27%, p=0.09) decreased comparably to RA patients. CONCLUSIONS: Overall, similar trends were observed for RA and pSS cohorts despite minor changes in pSS therapy. Work participation has improved significantly over two decades in pSS. A greater perception of pSS without systemic manifestations may have caused a shift towards less severely affected patient cohorts today.
Assuntos
Emprego/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Síndrome de Sjogren , Emprego/tendências , Feminino , Hospitalização/tendências , Humanos , Masculino , Licença Médica/estatística & dados numéricos , Licença Médica/tendênciasRESUMO
BACKGROUND: Little is known about the utilization of individual health services performed by a physician (IGeL) and the services and supplements provided outside a doctor's office (MuPaP) for osteoarthritis patients. OBJECTIVES: The aims of this study are to analyze the use of osteoarthritis-specific IGeL and MuPaP as well as predictors for their utilization. MATERIALS AND METHODS: For this cross-sectional study, claims data was used to identify all persons with hip, knee, or polyarticular osteoarthritis in 2014 (nâ¯= 657,807). A random sample (nâ¯= 8995) was sent a questionnaire about their usage of IGeL and MuPaP. Furthermore, the type of physicians conducting or recommending services was evaluated. Applying multivariable logistic regression, predictors associated with the utilization of IGeL, MuPaP, and overall individual health services were analyzed. RESULTS: After validating the data and osteoarthritis diagnosis, 2363 persons were enrolled (mean age: 65.5 years, 72% female). In the last 12 months, 39% of patients had used at least one IGeL (MuPaP: 76%), with 86% being primarily performed by orthopedists (MuPaP: 88% patient self-motivated). Knee osteoarthritis was associated with increased utilization of IGeL. Having female gender, higher income, residence in Western Germany, higher disease burden, and lower satisfaction with the healthcare system were influences on the use of overall individual health services. CONCLUSIONS: Since patients with high disease burden in particular tend to use these therapies with varying treatment success, detailed information, especially about the risks and existing evidence, should be a prerequisite for trustworthy doctor-patient relationships.