To develop European League Against Rheumatism (EULAR) recommendations for the management of large vessel vasculitis.
An expert group (10 rheumatologists, 3 nephrologists, 2 immunolgists, 2 internists ...representing 8 European countries and the USA, a clinical epidemiologist and a representative from a drug regulatory agency) identified 10 topics for a systematic literature search through a modified Delphi technique. In accordance with standardised EULAR operating procedures, recommendations were derived for the management of large vessel vasculitis. In the absence of evidence, recommendations were formulated on the basis of a consensus opinion.
Seven recommendations were made relating to the assessment, investigation and treatment of patients with large vessel vasculitis. The strength of recommendations was restricted by the low level of evidence and EULAR standardised operating procedures.
On the basis of evidence and expert consensus, management recommendations for large vessel vasculitis have been formulated and are commended for use in everyday clinical practice.
To develop European League Against Rheumatism (EULAR) recommendations for the management of small and medium vessel vasculitis.
An expert group (consisting of 10 rheumatologists, 3 nephrologists, 2 ...immunologists, 2 internists representing 8 European countries and the USA, a clinical epidemiologist and a representative from a drug regulatory agency) identified 10 topics for a systematic literature search using a modified Delphi technique. In accordance with standardised EULAR operating procedures, recommendations were derived for the management of small and medium vessel vasculitis. In the absence of evidence, recommendations were formulated on the basis of a consensus opinion.
In all, 15 recommendations were made for the management of small and medium vessel vasculitis. The strength of recommendations was restricted by low quality of evidence and by EULAR standardised operating procedures.
On the basis of evidence and expert consensus, recommendations have been made for the evaluation, investigation, treatment and monitoring of patients with small and medium vessel vasculitis for use in everyday clinical practice.
To facilitate access to evidence-based care for back pain, a German private medical insurance offered a health program proactively to their members. Feasibility and long-term efficacy of this ...approach were evaluated.
Using Zelen's design, adult members of the health insurance with chronic back pain according to billing data were randomized to the intervention (IG) or the control group (CG). Participants allocated to the IG were invited to participate in the comprehensive health program comprising medical exercise therapy and life style coaching, and those allocated to the CG to a longitudinal back pain survey. Primary outcomes were back pain severity (Korff's Chronic Pain Grade Questionnaire) as well as health-related quality of life (SF-12) assessed by identical online questionnaires at baseline and 2-year follow-up in both study arms. In addition to analyses of covariance, a subgroup analysis explored the heterogeneity of treatment effects among different risks of back pain chronification (STarT Back Tool).
Out of 3462 persons selected, randomized and thereafter contacted, 552 agreed to participate. At the 24-month follow-up, data on 189 of 258 (73.3%) of the IG were available, in the CG on 255 of 294 (86.7%). Significant, small beneficial effects were seen in primary outcomes: Compared to the CG, the IG reported less disability (1.6 vs 2.0; p = 0.025; d = 0.24) and scored better at the SF-12 physical health scale (43.3 vs 41.0; p < 0.007; d = 0.26). No effect was seen in back pain intensity and in the SF-12 mental health scale. Persons with medium or high risk of back pain chronification at baseline responded better to the health program in all primary outcomes than the subgroup with low risk at baseline.
After 2 years, the proactive health program resulted in small positive long-term improvements. Using risk screening prior to inclusion in the health program might increase the percentage of participants deriving benefits from it.
The trial was registered at the German Clinical Trials Register under DRKS00015463 retrospectively (dated 4 Sept 2018).
We undertook a systematic literature review as a background to the European League Against Rheumatism (EULAR) recommendations for conducting clinical trials in anti-neutrophil cytoplasm antibody ...associated vasculitis (AAV), and to assess the quality of evidence for outcome measures in AAV.
Using a systematic Medline search, we categorised the identified studies according to diagnoses. Factors affecting remission, relapse, renal function and overall survival were identified.
A total of 44 papers were reviewed from 502 identified by our search criteria. There was considerable inconsistency in definitions of end points. Remission rates varied from 30% to 93% in Wegener granulomatosis (WG), 75% to 89% in microscopic polyangiitis (MPA) and 81% to 91% in Churg-Strauss syndrome (CSS). The 5-year survival for WG, MPA and CSS was 74-91%, 45-76% and 60-97%. Relapse (variably defined) was common in the first 2 years but the frequency varied: 18% to 60% in WG, 8% in MPA, and 35% in CSS. The rate of renal survival in WG varied from 23% at 15 months to 23% at 120 months.
used to assess morbidity varied between studies. Ignoring the variations in definitions of the stage of disease, factors influencing remission, relapse, renal and overall survival included immunosuppressive therapy used, type of organ involvement, presence of ANCA, older age and male gender.
Factors influencing remission, relapse, renal and overall survival include the type of immunosuppressive therapy used, pattern of organ involvement, presence of ANCA, older age and male gender. Methodological variations between studies highlight the need for a consensus on terminology and definitions for future conduct of clinical studies in AAV.
Objectives: To develop the European League Against Rheumatism (EULAR) recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis. Methods: An expert consensus group ...was formed consisting of rheumatologists, nephrologists and specialists in internal medicine representing five European countries and the USA, a clinical epidemiologist and representatives from regulatory agencies. Using an evidence-based and expert opinion-based approach in accordance with the standardised EULAR operating procedures, the group identified nine topics for a systematic literature search through a modified Delphi technique. On the basis of research questions posed by the group, recommendations were derived for conducting clinical studies and/or clinical trials in systemic vasculitis. Results: Based on the results of the literature research, the expert committee concluded that sufficient evidence to formulate guidelines on conducting clinical trials was available only for anti-neutrophil cytoplasm antibody-associated vasculitides (AAV). It was therefore decided to focus the recommendations on these diseases. Recommendations for conducting clinical trials in AAV were elaborated and are presented in this summary document. It was decided to consider vasculitis-specific issues rather than general issues of trial methodology. The recommendations deal with the following areas related to clinical studies of vasculitis: definitions of disease, activity states, outcome measures, eligibility criteria, trial design including relevant end points, and biomarkers. A number of aspects of trial methodology were deemed important for future research. Conclusions: On the basis of expert opinion, recommendations for conducting clinical trials in AAV were formulated. Furthermore, the expert committee identified a strong need for well-designed research in non-AAV systemic vasculitides.
Vertebral fractures are associated with back pain and disability. There are, however, few prospective data looking at back pain and disability following identification of radiographic vertebral ...fracture. The aim of this analysis was to determine the impact of radiographically identified vertebral fracture on the subsequent occurrence of back pain and disability. Women aged 50 years and over were recruited from population registers in 18 European centers for participation in the European Prospective Osteoporosis Study. Participants completed an interviewer-administered questionnaire which included questions about back pain in the past year and various activities of daily living, and they had lateral spine radiographs performed. Participants in these centers were followed prospectively and had repeat spine radiographs performed a mean of 3.7 years later. In addition they completed a questionnaire with the same baseline questions concerning back pain and activities of daily living. The presence of prevalent and incident vertebral fracture was defined using established morphometric criteria. The data were analyzed using logistic regression with back pain or disability (present or absent) at follow-up as the outcome variable with adjustment made for the baseline value of the variable. The study included 2,260 women, mean age 62.2 years. The mean time between baseline and follow-up survey was 5.0 years. Two hundred and forty participants had prevalent fractures at the baseline survey, and 85 developed incident fractures during follow-up. After adjustment for age, center, and the baseline level of disability, compared with those without baseline prevalent fracture, those with a prevalent fracture (odds ratio OR = 1.4; 95% confidence interval CI 1.0 to 2.0) or an incident fracture (OR = 1.7; 95% CI, 0.9 to 3.2) were more likely to report disability at follow-up, though the confidence intervals embraced unity. Those with both a prevalent and incident fracture, however, were significantly more likely to report disability at follow-up (OR = 3.1; 95% CI, 1.4 to 7.0). After adjustment for age, center, and frequency of back pain at baseline, compared with those without baseline vertebral fracture, those with a prevalent fracture were no more likely to report back pain at follow-up (OR = 1.2; 95% CI, 0.8 to 1.7). There was a small increased risk among those with a preexisting fracture who had sustained an incident fracture during follow-up (OR = 1.6; 95% CI, 0.6 to 4.1) though the confidence intervals embraced unity. In conclusion, although there was no significant increase in the level of back pain an average of 5 years following identification of radiographic vertebral fracture, women who suffered a further fracture during follow-up experienced substantial levels of disability with impairment in key physical functions of independent living.
The baroque deity Chronos symbolizes much of what we intuitively connect with "chronic", but it must not obscure our view of the diversity of chronic diseases. Common to all forms is a prognostic ...implication: a chronic disease and all associated burden will accompany the patient for the rest of his/her life. Chronic diseases are in general multifocal disorders simultaneously affecting biological, psychic, and social equilibria. This requires systematic problem-screening and -assessment, including possible comorbidities. Comorbidity in a strict sense should be distinguished from risk factors, implications, complications, and consequences of the index disorder of interest. The assessment is usually followed by the shared identification of therapeutic goals and indications. In chronic disorders, a wide spectrum of diagnostic and therapeutic approaches, methods, and professions becomes relevant.
The aim of this study was to investigate the prevalence of pain and characteristics of pain (frequency, duration, intensity) among children and adolescents and to compare them across different age ...and gender groups.
735 children and adolescents aged 10-18 y from schools in the Luebeck region of Germany were surveyed using a modified German version of the self-completion pain questionnaire of Perquin and co-workers.
715 out of 735 questionnaires (97.3%) were returned completed. Pain during the preceding 3 mo was reported by 85.3% (n = 610) of the respondent children and adolescents. The prevalence of pain increased with age. The most common complaints were headache (65.6%), abdominal pain (47.7%), limb pain (46.4%) and back pain (38.6%). A pain duration of longer than 3 mo was reported by 45.5% (35.4% for longer than 6 mo). Pain once a week or more frequently was reported by 33.7% of children and adolescents.
Almost half of the surveyed children and adolescents had suffered complaints for longer than 3 mo. The experience of pain in general and especially pain with a duration of longer than 3 mo is very common in children and adolescents, and requires further attention. Further studies are necessary to investigate the natural course, functional implications and prognosis due to pain complaints in children and adolescents.
The OVIS study is a population-based study that aims at evaluating medical care in Schleswig-Holstein (Germany). In this paper, the health related quality of life (QoL, EORTC QLQ-C30 and -BR23) of ...1,927 women with breast cancer is reported. The global health status/QoL score was comparable to reference data of the age-adjusted German general population, but clinical meaningful differences (≥ 10 points) were found for all functioning scales (with the exception of physical functioning) and for three of the symptom scales/items (fatigue, dyspnoe, insomnia) with OVIS patients showing more deficits. Furthermore, OVIS patients scored higher on the item financial difficulties. Logistic regression analyses revealed that coming from an urban surrounding, having a higher social status and attendance to a regular aftercare predicted a good overall QoL, while factors that were related to perceived complications in the course of the therapy raised the risk for a low QoL rating. It is of interest, that attendance to a rehabilitation and interest in self-help groups independently predicted an increased risk for a low quality of life. Overall, we assume the global QoL is rating slightly too optimistic since major deficits were reported on the specific physical and functional scales/items.
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