Development and validation of a brief, descriptive Danish pain questionnaire (BDDPQ).

BACKGROUND: A new pain questionnaire should be simple, be documented to have discriminative function, and be related to previously used questionnaires. METHODS: Word meaning was validated by using bilingual Danish medical students and asking them to translate words taken from the Danish version of the McGill pain questionnaire into English. Evaluative word value was estimated using a visual analog scale (VAS). Discriminative function was assessed by having patients with one of six painful conditions (postherpetic neuralgia, phantom limb pain, rheumatoid arthritis, ankle fracture, appendicitis, or labor pain) complete the questionnaire. RESULTS: We were not able to find Danish words that were reliably back-translated to the English words 'splitting' or 'gnawing'. A simple three-word set of evaluative terms had good separation when rated on a VAS scale ('let' 17.5+/-6.5 mm; 'moderat' 42.7+/-8.6 mm; and 'staerk' 74.9+/-9.7 mm). The questionnaire was able to discriminate among the six painful conditions with 77% accuracy by just using the descriptive words. The accuracy of the questionnaire increased to 96% with the addition of evaluative terms (for pain at rest and with activity), chronicity (acute vs. chronic), and location of the pain. CONCLUSIONS: A Danish pain questionnaire that subjects and patients can self-administer has been developed and validated relative to the words used in the English McGill Pain questionnaire. The discriminative ability of the questionnaire among some common painful conditions has been tested and documented. The questionnaire may be of use in patient care and research

Open-label trial of anti-TNF-α in dermato- and polymyositis treated concomitantly with methotrexate

Background/Aims: To determine the efficacy of infliximab combined with weekly methotrexate in drug-naive recent-onset dermatomyositis and polymyositis. Methods: A multicentre open-label controlled trial was conducted. Disease activity was assessed using patient's and physician's disease activity assessment, manual muscle testing (MMT), handheld dynamometry, and serum CK. The primary objective was to assess the efficacy using MMT after a period of 26 weeks. Results: The study was terminated prematurely because of a low inclusion rate and a high drop-out rate due to disease progression and the occurrence of an infusion reaction. The few patients who did reach the primary endpoint showed improvement in all aspects studied. Conclusion: Infliximab combined with weekly methotrexate might be safe and well tolerated in a small subgroup of patients with drug-naive recent-onset myositis. At present, we do not advocate the use of this treatment because treatment response cannot be predicted beforehand. Copyright © 2008 S. Karger AG

Open-label trial of anti-TNF-alpha in dermato- and polymyositis treated concomitantly with methotrexate.

Item does not contain fulltextBACKGROUND/AIMS: To determine the efficacy of infliximab combined with weekly methotrexate in drug-naive recent-onset dermatomyositis and polymyositis. METHODS: A multicentre open-label controlled trial was conducted. Disease activity was assessed using patient's and physician's disease activity assessment, manual muscle testing (MMT), handheld dynamometry, and serum CK. The primary objective was to assess the efficacy using MMT after a period of 26 weeks. RESULTS: The study was terminated prematurely because of a low inclusion rate and a high drop-out rate due to disease progression and the occurrence of an infusion reaction. The few patients who did reach the primary endpoint showed improvement in all aspects studied. CONCLUSION: Infliximab combined with weekly methotrexate might be safe and well tolerated in a small subgroup of patients with drug-naive recent-onset myositis. At present, we do not advocate the use of this treatment because treatment response cannot be predicted beforehand

Patient-reported outcomes in polymyalgia rheumatica.

OBJECTIVE: To prospectively evaluate the disease course and the performance of clinical, patient-reported outcome (PRO) and musculoskeletal ultrasound measures in patients with polymyalgia rheumatica (PMR). METHODS: The study population included 85 patients with new-onset PMR who were initially treated with prednisone equivalent dose of 15 mg daily tapered gradually, and followed for 26 weeks. Data collection included physical examination findings, laboratory measures of acute-phase reactants, and PRO measures. Ultrasound evaluation was performed at baseline and Week 26 to assess for features previously reported to be associated with PMR. Response to corticosteroid treatment was defined as 70% improvement in PMR on visual analog scale (VAS). RESULTS: At baseline, 77% had hip pain in addition to shoulder pain and 100% had abnormal C-reactive protein or erythrocyte sedimentation rate. On ultrasound, 84% had shoulder findings and 32% had both shoulder and hip findings. Response to corticosteroid treatment occurred in 73% of patients by Week 4 and was highly correlated with percentage improvement in other VAS measures. Presence of ultrasound findings at baseline predicted response to corticosteroids at 4 weeks. Factor analysis revealed 6 domains that sufficiently represented all the outcome measures: PMR-related pain and physical function, an elevated inflammatory marker, hip pain, global pain, mental function, and morning stiffness. CONCLUSION: PRO measures and inflammatory markers performed well in assessing disease activity in patients with PMR. A minimum set of outcome measures consisting of PRO measures of pain and function and an inflammatory marker should be used in practice and in clinical trials in PMR