Browsing by Author "Kirwan, JR"
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- Low-dose glucocorticoid therapy in rheumatoid arthritis. A review on safety: published evidence and prospective trial dataPublication . Pereira da Silva, JA; Jacobs, JW; Kirwan, JR; Boers, M; Saag, KG; Inês, L; Koning, EJ
- Outcome Measures in Polymyalgia Rheumatica. A Systematic ReviewPublication . Duarte, C; Ferreira, R; Mackie, SL; Kirwan, JR; Pereira da Silva, JAOBJECTIVE: To identify the instruments used to assess polymyalgia rheumatica (PMR) in published studies. METHODS: A systematic literature review of clinical trials and longitudinal observational studies related to PMR, published from 1970 to 2014, was carried out. All outcome and assessment instruments were extracted and categorized according to core areas and domains, as defined by the OMERACT (Outcome Measures in Rheumatology) Filter 2.0. RESULTS: Thirty-five articles (3221 patients) were included: 12 randomized controlled trials (RCT); 3 nonrandomized trials; and 20 observational studies. More than 20 domains were identified, measured by 29 different instruments. The most frequently used measures were pain, morning stiffness, patient global assessment and physician global assessment, erythrocyte sedimentation rate, and C-reactive protein. The definition of outcomes varied considerably between studies. CONCLUSION: The outcome measures and instruments used in PMR are numerous and diversely defined. The establishment of a core set of validated and standardized outcome measurements is needed.
- Polymyalgia Rheumatica (PMR) Special Interest Group at OMERACT 11: outcomes of importance for patients with PMRPublication . Mackie, SL; Arat, S; Pereira da Silva, JA; Duarte, C; Halliday, S; Hughes, R; Morris, M; Pease, CT; Sherman, JW; Simon, LS; Walsh, M; Westhovens, R; Zakout, S; Kirwan, JRWe worked toward developing a core outcome set for clinical research studies in polymyalgia rheumatica (PMR) by conducting (1) patient consultations using modified nominal group technique; (2) a systematic literature review of outcome measures in PMR; (3) a pilot observational study of patients presenting with untreated PMR, and further discussion with patient research partners; and (4) a qualitative focus group study of patients with PMR on the meaning of stiffness, using thematic analysis. (1) Consultations included 104 patients at 4 centers. Symptoms of PMR included pain, stiffness, fatigue, and sleep disturbance. Function, anxiety, and depression were also often mentioned. Participants expressed concerns about diagnostic delay, adverse effects of glucocorticoids, and fear of relapse. (2) In the systematic review, outcome measures previously used for PMR include pain visual analog scores (VAS), morning stiffness, blood markers, function, and quality of life; standardized effect sizes posttreatment were large. (3) Findings from the observational study indicated that asking about symptom severity at 7 AM, or "on waking," appeared more relevant to disease activity than asking about symptom severity "now" (which depended on the time of assessment). (4) Preliminary results were presented from the focus group qualitative study, encompassing broad themes of stiffness, pain, and the effect of PMR on patients' lives. It was concluded that further validation work is required before a core outcome set in PMR can be recommended. Nevertheless, the large standardized effect sizes suggest that pain VAS is likely to be satisfactory as a primary outcome measure for assessing response to initial therapy of PMR. Dissection of between-patient heterogeneity in the subsequent treatment course may require attention to comorbidity as a potential confounding factor.
- Safety of low dose glucocorticoid treatment in rheumatoid arthritis: published evidence and prospective trial dataPublication . Pereira da Silva, JA; Jacobs, JW; Kirwan, JR; Boers, M; Saag, KG; Inês, L; Koning, EJAdverse effects of glucocorticoids have been abundantly reported. Published reports on low dose glucocorticoid treatment show that few of the commonly held beliefs about their incidence, prevalence, and impact are supported by clear scientific evidence. Safety data from recent randomised controlled clinical trials of low dose glucocorticoid treatment in RA suggest that adverse effects associated with this drug are modest, and often not statistically different from those of placebo.
- Updating the OMERACT filter: implications of filter 2.0 to select outcome instruments through assessment of "truth": content, face, and construct validityPublication . Tugwell, P; Boers, M; D'Agostino, MA; Beaton, D; Boonen, A; Bingham, CO; Choy, E; Conaghan, PG; Dougados, M; Duarte, C; Furst, DE; Guillemin, F; Gossec, L; Heiberg, T; van der Heijde, DM; Hewlett, S; Kirwan, JR; Kvien, TK; Landewé, RB; Mease, PJ; Østergaard, M; Simon, L; Singh, JA; Strand, V; Wells, GOBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Filter provides guidelines for the development and validation of outcome measures for use in clinical research. The "Truth" section of the OMERACT Filter requires that criteria be met to demonstrate that the outcome instrument meets the criteria for content, face, and construct validity. METHODS: Discussion groups critically reviewed a variety of ways in which case studies of current OMERACT Working Groups complied with the Truth component of the Filter and what issues remained to be resolved. RESULTS: The case studies showed that there is broad agreement on criteria for meeting the Truth criteria through demonstration of content, face, and construct validity; however, several issues were identified that the Filter Working Group will need to address. CONCLUSION: These issues will require resolution to reach consensus on how Truth will be assessed for the proposed Filter 2.0 framework, for instruments to be endorsed by OMERACT.