RADAI-5 to monitor rheumatoid arthritis.

Providing the physician with sufficient information about the disease course can be regarded as the most important requirement for any disease assessment tool besides easy applicability and time-sparing documentation. Applying the RADAI-5 in daily routine provides the patient's view at any time completing the questionnaire. In a first study, the RADAI-5 resulted to be highly significantly correlated to the RADAI, and all composite indexes. Changes of the RADAI-5, the DAS28-ESR, and the CDAI were significantly correlated, indicating the instrument's sensitivity to change. A second study including 392 RA patients led to the establishment of thresholds for disease activity categories according to the RADAI-5, as follows: 0.0 up to 1.4 for a remission-like state, 1.6 up to 3.0 for mild disease activity, 3.2 up to 5.4 for moderate and from 5.6 up to 10.0 for high disease activity. In a third study, remission according to the RADAI-5 appeared to be highly specific for the ACR/EULAR criteria for remission The RADAI-5 questionnaire constitutes an easily applicable tool for routine RA monitoring, providing physicians with reliable information about the disease course and sensitivity enough to sound the alarm should complications occur.

Occupational risk factors for osteoarthritis of the knee: a meta-analysis.

INTRODUCTION: Systematic reviews agree that knee osteoarthritis (OA) is related to occupational activities, but have not quantified the overall risks. METHODS: Systematic review of observational studies of knee OA and occupation. Job titles, elite sport, heavy work, kneeling, and other activities were included. Relative risk estimate and 95% confidence interval (CI) compared to sedentary work were retrieved or calculated for meta-analysis. Publication bias was examined with Egger tests and heterogeneity was determined with I(2) values and Q tests. Subgroup analysis was performed to examine causes of heterogeneity. A random effects model was performed to combine the data. RESULTS: Studies of knee OA (n=51), persistent knee pain (n=12) and knee OA progression (n=3) were retrieved. Occupational risks for knee OA were examined in a total of 526,343 subjects in 8 cohort/prospective/longitudinal studies, 25 cross-sectional studies and 18 case control studies. The overall odds ratio (OR) was 1.61 (95% CI 1.45-1.78) with significant heterogeneity (I(2)=83.6%). Study designs showed a positive association between knee OA and occupational activities; cohort (OR 1.38, 95% CI 1.10-1.74), cross-sectional (OR 1.57, 95% CI 1.37-1.81) and case control (OR 1.80, 95% CI 1.48-2.19). Overall there was evidence of publication bias (P<0.0001) which was apparent in the cross-sectional and case control studies (P<0.0001 and P=0.0247 respectively). CONCLUSIONS: Some occupational activities increase the risk of knee OA, although the influences of publication bias and heterogeneity are important limitations of this study. Prospective studies would greatly improve the evidence base.

European League Against Rheumatism recommendations for calcium pyrophosphate deposition. Part I: terminology and diagnosis.

OBJECTIVES: To agree terminology and to develop recommendations for the diagnosis of calcium pyrophosphate deposition (CPPD). METHODS: The European League Against Rheumatism (EULAR) CPPD Task Force, comprising 15 experts from 10 countries, agreed the terms and recommendations for diagnosis of CPPD using a Delphi consensus approach. Evidence was systematically reviewed and presented in terms of sensitivity, specificity and positive likelihood ratio (LR) to support diagnosis; ORs were used for association. Strength of recommendation (SOR) was assessed by the EULAR visual analogue scale. RESULTS: It was agreed that 'CPPD' should be the umbrella term that includes acute calcium pyrophosphate (CPP) crystal arthritis, osteoarthritis (OA) with CPPD and chronic CPP crystal inflammatory arthritis. Chondrocalcinosis (CC) defines cartilage calcification, most commonly due to CPPD and detected by imaging or histological examination. A total of 11 key recommendations were generated on the topics of clinical features, synovial fluid (SF) examination, imaging, comorbidities and risk factors. Definitive diagnosis of CPPD relies on identification of SF CPP crystals. Rapid onset inflammatory symptoms and signs are suggestive but not definitive for acute CPP crystal arthritis. Radiographic CC is not highly sensitive or specific, whereas ultrasonography appears more useful (LR=24.2, 95% CI 3.51 to 168.01) for peripheral joints. Recognised risk factors for CPPD include ageing, OA and metabolic conditions such as primary hyperparathyroidism, haemochromatosis and hypomagnesaemia; familial forms are rare. SORs varied from 53 to 99 (maximum 100). CONCLUSION: New terms for CPPD were agreed and 11 key recommendations for diagnosis of CPPD were developed using research evidence and expert consensus.

EULAR recommendations for calcium pyrophosphate deposition. Part II: management.

OBJECTIVES: To develop evidence-based recommendations for management of calcium pyrophosphate deposition (CPPD). METHODS: A multidisciplinary guideline development group of 15 experts, representing 10 European countries, generated key propositions for management of CPPD using a Delphi consensus approach. For each recommendation research evidence was searched systematically. Whenever possible, the effect size and number needed to treat for efficacy and RR or OR for side effects were calculated for individual treatment modalities. Strength of recommendation was assessed by the European League Against Rheumatism visual analogue scale. RESULTS: Nine key recommendations were generated, including topics for general management, treatment of acute attacks, prophylaxis against recurrent acute attacks and management of chronic symptoms. It was recommended that optimal treatment requires both non-pharmacological and pharmacological treatments. For acute CPP crystal arthritis, cool packs, temporary rest and joint aspiration combined with steroid injection are often sufficient. For prophylaxis or chronic inflammatory arthritis with CPPD, oral non-steroidal anti-inflammatory drugs with gastroprotective treatment and/or low-dose colchicine 0.5-1.0 mg daily may be used. Other recommendations included parenteral or oral corticosteroid for acute CPP arthritis in those unresponsive or unsuited to other measures, and low-dose corticosteroid, methotrexate or hydroxychloroquine for chronic inflammatory arthritis with CPPD. Asymptomatic CPPD requires no treatment. Strength of recommendations varies from 79% to 95%. CONCLUSION: Nine key recommendations for management of CPP crystal associated arthritis were developed using both research evidence and expert consensus. Strength of recommendations was provided to assist the application of these recommendations.

Multinational evidence-based recommendations on how to investigate and follow-up undifferentiated peripheral inflammatory arthritis: integrating systematic literature research and expert opinion of a broad international panel of rheumatologists in the 3E Initiative.

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.

EULAR evidence-based recommendations for the diagnosis of knee osteoarthritis.

OBJECTIVE: To develop evidence-based recommendations for the diagnosis of knee osteoarthritis (OA). METHODS: The multidisciplinary guideline development group, representing 12 European countries, generated 10 key propositions regarding diagnosis using a Delphi consensus approach. For each recommendation, research evidence was searched systematically. Whenever possible, the sensitivity, specificity and likelihood ratio were calculated for individual diagnostic indicators and a diagnostic ladder was developed using Bayes' method. Secondary analyses were undertaken to test directly the recommendations using multiple predictive models in two populations from the UK and the Netherlands. Strength of recommendation was assessed by the EULAR visual analogue scale. RESULTS: Recommendations covered the definition of knee OA and its risk factors, subsets, typical symptoms and signs, the use of imaging and laboratory tests and differential diagnosis. Three symptoms (persistent knee pain, limited morning stiffness and reduced function) and three signs (crepitus, restricted movement and bony enlargement) appeared to be the most useful. Assuming a 12.5% background prevalence of knee OA in adults aged > or =45 years, the estimated probability of having radiographic knee OA increased with increasing number of positive features, to 99% when all six symptoms and signs were present. The performance of the recommendations in the study populations varied according to the definition of knee OA, background risk and number of tests applied. CONCLUSION: 10 key recommendations for diagnosis of knee OA were developed using both research evidence and expert consensus. Although there is no agreed reference standard, thorough clinical assessment alone can provide a confident rule-in diagnosis.

Comparison of three rheumatoid arthritis disease activity scores in clinical routine.

OBJECTIVE: To evaluate whether the revised disease activity cut-off values for the Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI) are in congruence with the Disease Activity Score including a 28-joint count (DAS28) disease activity criteria in daily clinical routine. PATIENTS AND METHODS: A total of 570 rheumatoid arthritis (RA) outpatients were assessed and categorized according to the DAS28, the SDAI, and the CDAI. These results were compared to the respective DAS28 disease activity categories. Statistical evaluation was carried out by calculating alpha, the Spearman rank correlation, and kappa-statistics. RESULTS: DAS28, SDAI, and CDAI levels were significantly correlated to one another on a group level (p < 0.001). Internal consistency was the highest for the CDAI (alpha = 0.783) and the lowest for the DAS28 (alpha = 0.664). Kappa-statistics revealed a substantial degree of agreement with respect to mild, moderate, and high disease activity according to the three scores, with exceptions concerning the definition of a remission-like state. Further categorization showed that an additional 44% of patients were found to be in remission according to the DAS28 disease activity criteria relative to those defined by the SDAI or the CDAI disease activity categories respectively. CONCLUSION: The revised SDAI limits for disease activity and the respective CDAI thresholds proved to be in congruence with the DAS28 disease activity categories in daily clinical routine. The SDAI and the CDAI were found to be more stringent in defining remission.

EULAR evidence-based recommendations for the diagnosis of hand osteoarthritis: report of a task force of ESCISIT.

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.

Multinational evidence-based recommendations for the use of methotrexate in rheumatic disorders with a focus on rheumatoid arthritis: integrating systematic literature research and expert opinion of a broad international panel of rheumatologists in the 3E Initiative.

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.

A tool for the assessment of hand involvement in rheumatic disorders in daily routine--the SF-SACRAH (short form score for the assessment and quantification of chronic rheumatic affections of the hands).

OBJECTIVE: To establish a questionnaire for quantification of hand involvement in osteoarthritis (OA) of the hands and rheumatoid arthritis (RA) meeting daily routine requirements. PATIENTS AND METHODS: The smallest number of questions of the modified score for the assessment and quantification of chronic rheumatic affections of the hands (M-SACRAH) providing reasonable reliability was identified by factor analysis and calculating Cronbach's alpha, subsequently resulting in a five-item scale, the short form-SACRAH (SF-SACRAH), which was then administered to 176 RA and 71 hand-OA (HOA) patients simultaneously with the M-SACRAH. Additionally, patient's satisfaction (PatSAT) with disease status was assessed (according to the Austrian school marking system from 1 to 5). Gamma was calculated to assess the agreement of the SF-SACRAH with the M-SACRAH and between the single corresponding questions of different formats. The Wilcoxon rank test was applied to estimate the relationship between PatSAT and the SF-SACRAH. RESULTS: Alpha for the SF-SACRAH in 176 RA and 71 HOA patients amounted to 0.869 and to 0.897, respectively, indicating high internal consistency. In both patient groups the SF-SACRAH was found to be significantly correlated to the M-SACRAH (both P(s)<0.01). Agreement between the corresponding questions of both scales was significant in both patient groups by calculating gamma (average gamma 0.683 in HOA and 0.847 in RA). PatSAT and SF-SACRAH values were highly significantly correlated (P<0.001) proving the score's external validity. CONCLUSION: The SF-SACRAH proved to be a brief and practicable tool to assess hand involvement in OA and RA meeting the requirements of daily routine.

SDAI/CDAI levels in rheumatoid arthritis patients are highly dependent on patient's pain perception and gender.

OBJECTIVE: To determine whether the Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI) are equally applicable for the total population with rheumatoid arthritis (RA). METHODS: Five hundred and fifty-seven outpatients with RA [432 females, 125 males; median age 64 years (range 18-85); median disease duration 48 months (range 2-548)] were enrolled consecutively in this cross-sectional study. SDAI, CDAI, patient's assessment of pain on the visual analogue scale (VAS) 0-100, rheumatoid factor (RF), and disease duration were recorded. Linear regression analysis was performed for each confounding factor. RESULTS: The median SDAI for all 557 patients was 11.6 (range 0.07-46.60) and the median CDAI was 10.7 (0.00-42.10). The median SDAI was 12.2 (0.07-46.60) in females and 8.0 (0.10-35.20) in males. The respective medians for the CDAI were 11.3 (0.00-42.10) and 7.1 (0.00-32.00). These differences were highly statistically significant (p<0.001). Patient's assessment of pain on the VAS 0-100 scale had a median value of 32 mm. Regression analysis revealed a highly significant relationship between SDAI/CDAI levels and patient's pain rating (SDAI: r = 0.660, p<0.001; CDAI: r = 0.671, p<0.001). On multiple regression analysis, pain exerted a highly significant influence on SDAI and CDAI levels (p<0.001), whereas age, disease duration, and RF were not correlated with either level. CONCLUSION: SDAI and CDAI values are highly dependent on the patient's pain perception and gender. The effects of patient's age, disease duration, and RF were inconclusive with respect to the values of the respective disease activity indexes.

[European League Against Rheumatism evidence-based recommendations for diagnosis and management of gout]. / Evidenzbasierte Empfehlungen der "European League Against Rheumatism" zur Diagnostik und Therapie der Gicht.

Gout cannot be regarded a benign disease, as it is unfortunately often misunderstood. In view of the lack of recent evidence-based recommendations for the diagnosis and management of gout, the European League Against Rheumatism (EULAR) decided to commission a task force to develop such recommendations. A literature search was performed to comprehensively assess the clinical and epidemiological aspects, diagnostic tools, as well as effectiveness of therapeutic measures and the overall management. Subsequently, consensus among the participating experts should be achieved by applying a Delphi process. As a result of this project 10 recommendations for diagnosis of gout as well as 12 recommendations with respect to the management of the disease could be elaborated. Gout can be regarded as a disease with excellent prognosis in the light of the diagnostic and therapeutic possibilities available. However, this only holds true if all these possibilities are applied in the appropriate manner in daily routine. It constituted the primary goal of the EULAR project to deliver a substantial contribution to improve routine care of affected patients.

EULAR evidence based recommendations for the management of hand osteoarthritis: report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT).

OBJECTIVES: To develop evidence based recommendations for the management of hand osteoarthritis (OA). METHODS: The multidisciplinary guideline development group comprised 16 rheumatologists, one physiatrist, one orthopaedic surgeon, two allied health professionals, and one evidence based medicine expert, representing 15 different European countries. Each participant contributed up to 10 propositions describing key clinical points for management of hand OA. Final recommendations were agreed using a Delphi consensus approach. A systematic search of Medline, Embase, CINAHL, Science Citation Index, AMED, Cochrane Library, HTA, and NICE reports was used to identify the best available research evidence to support each proposition. Where possible, the effect size and number needed to treat were calculated for efficacy. Relative risk or odds ratio was estimated for safety, and incremental cost effectiveness ratio was used for cost effectiveness. The strength of recommendation was provided according to research evidence, clinical expertise, and perceived patient preference. RESULTS: Eleven key propositions involving 17 treatment modalities were generated through three Delphi rounds. Treatment topics included general considerations (for example, clinical features, risk factors, comorbidities), non-pharmacological (for example, education plus exercise, local heat, and splint), pharmacological (for example, paracetamol, NSAIDs, NSAIDs plus gastroprotective agents, COX-2 inhibitors, systemic slow acting disease modifying drugs, intra-articular corticosteroids), and surgery. Of 17 treatment modalities, only six were supported by research evidence (education plus exercise, NSAIDs, COX-2 inhibitors, topical NSAIDs, topical capsaicin, and chondroitin sulphate). Others were supported either by evidence extrapolated from studies of OA affecting other joint sites or by expert opinion. Strength of recommendation varied according to level of evidence, benefits and harms/costs of the treatment, and clinical expertise. CONCLUSION: Eleven key recommendations for treatment of hand OA were developed using a combination of research based evidence and expert consensus. The evidence was evaluated and the strength of recommendation was provided.

EULAR evidence based recommendations for gout. Part II: Management. Report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT).

OBJECTIVE: To develop evidence based recommendations for the management of gout. METHODS: The multidisciplinary guideline development group comprised 19 rheumatologists and one evidence based medicine expert representing 13 European countries. Key propositions on management were generated using a Delphi consensus approach. Research evidence was searched systematically for each proposition. Where possible, effect size (ES), number needed to treat, relative risk, odds ratio, and incremental cost-effectiveness ratio were calculated. The quality of evidence was categorised according to the level of evidence. The strength of recommendation (SOR) was assessed using the EULAR visual analogue and ordinal scales. RESULTS: 12 key propositions were generated after three Delphi rounds. Propositions included both non-pharmacological and pharmacological treatments and addressed symptomatic control of acute gout, urate lowering therapy (ULT), and prophylaxis of acute attacks. The importance of patient education, modification of adverse lifestyle (weight loss if obese; reduced alcohol consumption; low animal purine diet) and treatment of associated comorbidity and risk factors were emphasised. Recommended drugs for acute attacks were oral non-steroidal anti-inflammatory drugs (NSAIDs), oral colchicine (ES = 0.87 (95% confidence interval, 0.25 to 1.50)), or joint aspiration and injection of corticosteroid. ULT is indicated in patients with recurrent acute attacks, arthropathy, tophi, or radiographic changes of gout. Allopurinol was confirmed as effective long term ULT (ES = 1.39 (0.78 to 2.01)). If allopurinol toxicity occurs, options include other xanthine oxidase inhibitors, allopurinol desensitisation, or a uricosuric. The uricosuric benzbromarone is more effective than allopurinol (ES = 1.50 (0.76 to 2.24)) and can be used in patients with mild to moderate renal insufficiency but may be hepatotoxic. When gout is associated with the use of diuretics, the diuretic should be stopped if possible. For prophylaxis against acute attacks, either colchicine 0.5-1 mg daily or an NSAID (with gastroprotection if indicated) are recommended. CONCLUSIONS: 12 key recommendations for management of gout were developed, using a combination of research based evidence and expert consensus. The evidence was evaluated and the SOR provided for each proposition.

EULAR evidence based recommendations for gout. Part I: Diagnosis. Report of a task force of the Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT).

OBJECTIVE: To develop evidence based recommendations for the diagnosis of gout. METHODS: The multidisciplinary guideline development group comprised 19 rheumatologists and one evidence based medicine expert, representing 13 European countries. Ten key propositions regarding diagnosis were generated using a Delphi consensus approach. Research evidence was searched systematically for each proposition. Wherever possible the sensitivity, specificity, likelihood ratio (LR), and incremental cost-effectiveness ratio were calculated for diagnostic tests. Relative risk and odds ratios were estimated for risk factors and co-morbidities associated with gout. The quality of evidence was categorised according to the evidence hierarchy. The strength of recommendation (SOR) was assessed using the EULAR visual analogue and ordinal scales. RESULTS: 10 key propositions were generated though three Delphi rounds including diagnostic topics in clinical manifestations, urate crystal identification, biochemical tests, radiographs, and risk factors/co-morbidities. Urate crystal identification varies according to symptoms and observer skill but is very likely to be positive in symptomatic gout (LR = 567 (95% confidence interval (CI), 35.5 to 9053)). Classic podagra and presence of tophi have the highest clinical diagnostic value for gout (LR = 30.64 (95% CI, 20.51 to 45.77), and LR = 39.95 (21.06 to 75.79), respectively). Hyperuricaemia is a major risk factor for gout and may be a useful diagnostic marker when defined by the normal range of the local population (LR = 9.74 (7.45 to 12.72)), although some gouty patients may have normal serum uric acid concentrations at the time of investigation. Radiographs have little role in diagnosis, though in late or severe gout radiographic changes of asymmetrical swelling (LR = 4.13 (2.97 to 5.74)) and subcortical cysts without erosion (LR = 6.39 (3.00 to 13.57)) may be useful to differentiate chronic gout from other joint conditions. In addition, risk factors (sex, diuretics, purine-rich foods, alcohol, lead) and co-morbidities (cardiovascular diseases, hypertension, diabetes, obesity, and chronic renal failure) are associated with gout. SOR for each proposition varied according to both the research evidence and expert opinion. CONCLUSIONS: 10 key recommendations for diagnosis of gout were developed using a combination of research based evidence and expert consensus. The evidence for diagnostic tests, risk factors, and co-morbidities was evaluated and the strength of recommendation was provided.

Lack of agreement between patients' and physicians' perspectives of rheumatoid arthritis disease activity changes.

OBJECTIVE: To obtain information on changes in patients' satisfaction (PATSAT) and physicians' global assessment (PhGASS) with regard to rheumatoid arthritis (RA) activity fluctuations. METHODS: Eighty-eight RA outpatients out of 207 investigated were assessed for 3 months on average after the initial evaluation. PATSAT (1 = excellent to 5 = unsatisfactory), PhGASS (visual analogue scale 1-100), and the 28-joint Disease Activity Score (DAS28) were assessed as at the first evaluation. The only prerequisite for enrolment was any therapeutic change at the first visit. Changes in PATSAT (SATCH) and PhGASS (PhGACH) were categorized and subsequently related to the DAS28 changes. Statistical evaluation was carried out by the Kruskal-Wallis test, the Mann-Whitney U-test, and by kappa statistics. RESULTS: To achieve a positive SATCH (n = 26/88 patients), a median DAS28 reduction of -1.06 (-25.0%) was necessary, whereas a considerably lower median increase of +0.16 (+10.5%) caused a negative SATCH. PhGASS (n = 38/88 patients) changed positively on a median DAS28 reduction of -0.82 (-16.0%), whereas it worsened at a mean DAS28 increase of +0.55 (+16.5%). Approximately 60% congruence between SATCH and PhGACH could be observed (kappa = 0.139). The DAS28 values preceding a positive SATCH and PhGACH were significantly higher (p < 0.001) than before a negative change. CONCLUSION: The patients' perspective with respect to improvement or worsening of RA is asymmetric. In contrast to the physicians' perspective, patients require greater improvement to be satisfied and less deterioration to be dissatisfied. These results may provide additional guidance in considerations about defining response and non-response in RA.

[Modern antirheumatic pharmacotherapy. Low molecular weight substances vs. biologicals]. / Moderne antirheumatische Pharmakotherapie Niedermolekulare Substanzen vs. Biologicals.

Rheumatoid arthritis potentially causes joint destruction, organ failures, and accompanying disorders. Therefore initiating therapeutic measures as early as possible is crucial, whereby symptomatic treatment only is definitely insufficient. Among the traditional disease-modifying antirheumatic drugs (DMARD) Methotrexate is regarded the gold standard. Increasing knowledge of cell-interactions, particularly of the cytokine-cascade, resulted in new therapeutic options. Direct impact via "biologicals" on key inflammatory mediators, primarily TNF-alpha, offers the possibility of effectively modulating or even arresting disease progression. Nowadays, those substances are applied in non-responders to traditional DMARD. Despite their benefits, cons like an increased risk for infections, for exacerbating latent tuberculosis and possibly for malignancies must be considered. Thus, a thorough patient check-up before initiating these therapies is mandatory. Pharmacoeconomic aspects influence the discussion about these "new therapies". The high costs of biologicals, however, should be related to the possible reduction of the diseases psychological, social and economic burdens.

A comparison of the sensitivity of diagnostic criteria for polymyalgia rheumatica.

OBJECTIVE: To compare the performance of the several different diagnostic criteria sets currently in use for polymyalgia rheumatica (PMR). METHODS: 213 patients attending eight rheumatological centres in eight different European countries were studied. All had recently been referred and were considered by the senior investigator at each centre, selected because of their experience in treatment of PMR, to have this condition. By use of a standard international proforma, the requisite diagnostic points in each criteria set were sought. Sensitivity for each criterion from each set was then calculated, as well as the sensitivity of each criteria set as a whole. RESULTS: Of four criteria sets compared, the Bird (1979) criteria performed best with a sensitivity of 99.5%, and the Hunder (1982) criteria second best, with sensitivity of 93.3%. These both performed significantly better than the two other criteria sets, though each of these was admittedly developed for rather specialised reasons. CONCLUSIONS: Although this study compares homogeneity, we suggest the Bird 1979 or Hunder 1982 criteria should be used whenever possible. Studies that have used alternative criteria may have less sensitivity in diagnosis.