Expert evaluations of fatigue questionnaires used in rheumatoid arthritis: a Delphi study among patients, nurses and rheumatologists in the Netherlands.

OBJECTIVES: Evaluating fatigue items from traditional questionnaires and a new scale (BRAF-MDQ) by experts in rheumatoid arthritis (RA). This evaluation was part of a study to select fatigue items to develop an item bank for a Dutch computer-adaptive test (CAT) for RA. Experts' opinions were incorporated since they are essential for content validity of measurement instruments. METHODS: The 60 items of the SF-36 subscale vitality, FACIT-F, POMS subscale fatigue/inertia, MAF and the recently developed BRAF-MDQ were evaluated by rheumatologists, nurses and RA patients in a Delphi procedure. Items were selected for development of the item bank/CAT if rated as adequate by at least 80% of the participants (when 50% or less they were excluded). On the basis of participants' comments, remaining items were re-worded and re-evaluated in the following round. The procedure stopped when all items were selected or rejected. RESULTS: Ten rheumatologists, 20 nurses and 15 RA patients participated. After the first round, 40% of the traditional items and 60% of the BRAF-MDQ items were directly selected and 3 items of the traditional questionnaires and 1 item of the BRAF-MDQ were directly excluded. Remaining items were re-worded, eight of which were presented for re-evaluation in the second round. Finally, 90% of the items from the traditional questionnaires and 95% of the items from the new BRAF-MDQ were included in our item pool. CONCLUSIONS: Fifty-five of the 60 items (92%) from fatigue questionnaires proved to have good content validity and were feasible for use in the Netherlands, some after adaptation.

The efficacy of anti-TNF in rheumatoid arthritis, a comparison between randomised controlled trials and clinical practice.

BACKGROUND: Randomised controlled trials (RCTs) evaluating the efficacy of antagonists to tumour necrosis factor alpha (TNFalpha) showed high response percentages in the groups treated with active drugs. OBJECTIVE: To compare the efficacy of anti-TNF treatments for rheumatoid arthritis (RA) patients in RCTs and in daily clinical practice, with an emphasis on the efficacy for patients eligible and not eligible for RCTs of anti-TNF treatments. METHODS: First, randomised placebo-controlled trials written in English for etanercept, infliximab and adalimumab for patients with RA were selected by a systematic review. Second, the DREAM (Dutch Rheumatoid Arthritis Monitoring) register with patients starting for the first time on one of the TNF-blocking agents was used. Patient characteristics, doses of medication and co-medication as well as the ACR20 response percentages were compared between RCTs and DREAM data, stratified for trial eligibility. RESULTS: In 10 of 11 comparisons, the ACR20 response percentages were lower in daily clinical practice than in the RCT active drug group, which was significant in five of 11 comparisons. Only 34-79% of DREAM patients fulfilled the selection criteria for disease activity in the several RCTs examined. DREAM patients eligible for RCTs had higher response percentages than ineligible DREAM patients. ACR20 response percentages of eligible DREAM patients were comparable with the ACR20 response percentages of the RCT active drug group in 10 of 11 comparisons. CONCLUSION: The efficacy of TNF-blocking agents in RCTs exceeded the efficacy of these drugs in clinical practice. However, in clinical practice more patients with lower disease activity were treated with TNF-blocking agents compared with those treated in RCTs. For daily practice patients who were eligible for RCTs, responses were more similar to responses reached in RCTs.

Influence of guideline adherence on outcome in a randomised controlled trial on the efficacy of methotrexate with folate supplementation in rheumatoid arthritis.

OBJECTIVE: To study the influence of rheumatologists' adherence to a methotrexate guideline on efficacy and toxicity in the treatment of rheumatoid arthritis. METHODS: In a 48 week randomised controlled trial of methotrexate, comparing folates with placebo, rheumatologists were advised on methotrexate dosage using a guideline reflecting daily practice. The influence of guideline non-adherence on outcome was analysed using generalised estimating equations and survival analysis. RESULTS: In 51% of the 411 study patients the guidelines were always followed. Non-adherence resulted in lower doses of methotrexate in 25% of cases, and higher doses in 24%. The reduction in the disease activity score was significantly greater (mean -0.4; p = 0.0085) in the adherent group than in the "low dose" group; the "high dose" group did not differ from the adherent group. Dropout caused by severe adverse events did not differ between the three groups. CONCLUSIONS: There is an indication that adherence to guidelines on methotrexate dosage may benefit patients with rheumatoid arthritis by improving disease activity without increasing toxicity. For definite proof, a randomised controlled trial comparing guideline supported dosing with usual care is needed.

The prevalence of H. pylori is still substantial in rheumatic patients.

The separate contribution of NSAIDs and H. pylori in the pathogenesis of peptic ulcer disease has not been fully elucidated. The aim of this study was to investigate the seroprevalence of H. pylori in patients with rheumatic diseases and chronic NSAID treatment. Patients with a rheumatic disease, age 40-80 years, and regular use of NSAIDs (at least 3 times a week) were included (n= 1214). IgG-antibodies to H. pylori were found in 39% and increased gradually with age: from 25% in patients in the 40-50 years age group to 48% in patients aged 70-80 years (p<0.0001). No difference was observed between men and women, or between the three centres. In our population of rheumatic patients treated with NSAIDs the seroprevalence of H. pylori is substantial (39%), but seems to be lower than in previous reports, which may be due to a cohort effect.