Publications (2)11.56 Total impact
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Article: Identifying the clinical domains of fibromyalgia: contributions from clinician and patient Delphi exercises.
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ABSTRACT: In evaluating the effectiveness of fibromyalgia (FM) therapies, it is important to assess the impact of those therapies on the full array of domains considered important by both clinicians and patients. The objective of this research was to identify and prioritize the key clinically relevant and important domains impacted by FM that should be evaluated by outcome assessment instruments used in FM clinical trials, and to approach consensus among clinicians and patients on the priority of those domains to be assessed in clinical care and research. Group consensus was achieved using the Delphi method, a structured process of consensus building via questionnaires together with systematic and controlled opinion feedback. The Delphi exercises involved 23 clinicians with expertise in FM and 100 patients with FM as defined by American College of Rheumatology criteria. The Delphi exercise revealed that the domains ranked most highly by patients were similar to the domain rankings by clinicians. Pain was consistently ranked highest by both panels. Fatigue, impact on sleep, health-related quality of life, comorbid depression, and cognitive difficulty were also ranked highly. Stiffness was ranked highly by patients but not clinicians. In contrast, side effects was important to clinicians but was not identified as important in the patient Delphi exercise. The clinician and patient Delphi exercises identified and ranked key domains that need to be assessed in FM research. Based on these results, a conceptual framework for measuring patient-reported outcomes is proposed.Arthritis & Rheumatism 08/2008; 59(7):952-60. · 7.87 Impact Factor -
Article: Pneumococcal vaccine response in psoriatic arthritis patients during treatment with etanercept.
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ABSTRACT: Therapeutics used to treat inflammatory diseases, including psoriatic arthritis (PsA), may potentially interfere with normal immune system function. Immune system function can be assessed by evaluating response to vaccination. We assessed the ability of patients with PsA treated with etanercept to produce antibodies in response to pneumococcal antigen challenge. Patients with PsA (n = 205) were stratified by methotrexate (MTX) use and randomly assigned to receive either placebo or etanercept 25 mg twice weekly by subcutaneous injection. After 4 weeks of treatment with study drug, a 23-valent pneumococcal vaccination was administered. Antibody levels to 5 antigens (9V, 14, 18C, 19F, and 23F) were measured by ELISA before and 4 weeks after vaccination in 184 patients. The proportion (%) of patients with 2- and 4-fold increases in antibody titers was analyzed. Patients treated with etanercept or placebo had similar responses to the vaccine. A 2-fold increase in titer to at least 2 antigens was achieved by 67% of patients, and a 4-fold increase to at least 2 antigens was achieved by 47% of patients. Approximately 20% of patients in each group failed to show a 2-fold response to any antigens. Logistic regression analysis showed MTX use and age were predictors of a poor response. Patients with PsA treated with etanercept were able to produce antibodies in response to pneumococcal vaccination. Patients receiving MTX had lower mean antibody levels in response to the vaccine. There was no increased risk of poor response with etanercept treatment given alone or with MTX.The Journal of Rheumatology 08/2004; 31(7):1356-61. · 3.69 Impact Factor
