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Research ArticleOMERACT

Establishing a Core Domain Set to Measure Rheumatoid Arthritis Flares: Report of the OMERACT 11 RA Flare Workshop

Vivian P. Bykerk, Elisabeth Lie, Susan J. Bartlett, Rieke Alten, Annelies Boonen, Robin Christensen, Daniel E. Furst, Sarah Hewlett, Amye L. Leong, Anne Lyddiatt, Lyn March, James E. May, Pam Montie, Ana-Maria Orbai, Christoph Pohl, Marieke Scholte Voshaar, Thasia Woodworth, Clifton O. Bingham III and Ernest H. Choy
The Journal of Rheumatology April 2014, 41 (4) 799-809; DOI: https://doi.org/10.3899/jrheum.131252
Vivian P. Bykerk
From the Department of Rheumatology, Hospital for Special Surgery, New York, New York, USA; Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway; Johns Hopkins University, Baltimore, Maryland, USA; McGill University, Montreal, Quebec, Canada; Schlosspark Klinik, Charité University Medicine, Berlin, Germany; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht, The Netherlands; Musculoskeletal Statistics Unit, The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Denmark; David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California, USA; University of the West of England, Bristol, UK; Healthy Motivation, Bone and Joint Decade, Santa Barbara, California, USA; Musculoskeletal Group, Cochrane Collaboration; University of Sydney Department of Rheumatology, Royal North Shore Hospital, St. Leonards, Australia; National Fathers’ Network, Seattle, Washington, USA; Arthritis Research Center, Vancouver, British Columbia, Canada; Tools2use.eu, Bussum, The Netherlands; and the Department of Rheumatology, Cardiff University, Cardiff, UK.
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  • For correspondence: bykerkv{at}hss.edu
Elisabeth Lie
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Susan J. Bartlett
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Rieke Alten
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Annelies Boonen
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Robin Christensen
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Daniel E. Furst
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Sarah Hewlett
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Amye L. Leong
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Anne Lyddiatt
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Lyn March
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James E. May
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Pam Montie
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Ana-Maria Orbai
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Christoph Pohl
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Marieke Scholte Voshaar
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Thasia Woodworth
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Clifton O. Bingham III
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Ernest H. Choy
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  • Figure 1A.
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    Figure 1A.

    Work plan of OMERACT RA Flare Working Group. HCP: healthcare professional; RCT: randomized controlled trials; LOS: longitudinal observational studies.

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    Figure 1B.

    Core domain set to measure RA flare aligns with OMERACT Filter 2.0 (from Boers M, et al. J Clin Epidemiol 2014; in press; adapted with permission16).

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    Figure 2.

    Consensus agreement for inclusion of domains used to define rheumatoid arthritis (RA) flare among patients and their healthcare professionals (HCP)10. Bubble size reflects the relative precision of each estimate. Domains reflecting the 1993 American College of Rheumatology preliminary core set for disease activity measures for RA clinical trials are shaded33. From Bartlett, et al. Ann Rheum Dis 2012;71:1855–60; used with permission.

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    Figure 3.

    Core domain set to identify and measure rheumatoid arthritis flare.

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    Table 1.

    Research agenda for the Rheumatoid Arthritis Flare Working Group from OMERACT 11.

    1. Identify existing instruments and develop new measures to evaluate each patient-valued domain included in the core set and research agenda for RA flare including:

      1. Self-Management (and evaluation beyond RA)

      2. Stiffness

      3. Participation

    2. Examine other domains of importance to patients:

      1. Sleep

      2. Emotional distress

      3. Systemic Features

    3. Assess and validate flare domains by analyzing OMERACT preliminary flare questions in several longitudinal observation studies and two randomized control trials

    4. Employ methods, including item response therapy in the analysis and summation of multi-dimensional data for flare to evaluate thresholds of HCP and patient described domains associated with disease worsening

    5. Assess domain measures in the context of a (i) “Patient global question” with well characterized and validated anchors, (ii) Patient assessment using a flare questionnaire in the context of available PROs at the time of each self-report, (iii) Physician/HCP assessments of disease activity, and (iv) treatment change.

    6. Evaluate linguistic and cultural factors that pertain to domain identification and instrument selection and validation [Ref 32]

    7. Determine whether flare should be represented as a change or a state(or both)

    8. Determine duration/persistence criterion for defining flare

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The Journal of Rheumatology
Vol. 41, Issue 4
1 Apr 2014
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Establishing a Core Domain Set to Measure Rheumatoid Arthritis Flares: Report of the OMERACT 11 RA Flare Workshop
Vivian P. Bykerk, Elisabeth Lie, Susan J. Bartlett, Rieke Alten, Annelies Boonen, Robin Christensen, Daniel E. Furst, Sarah Hewlett, Amye L. Leong, Anne Lyddiatt, Lyn March, James E. May, Pam Montie, Ana-Maria Orbai, Christoph Pohl, Marieke Scholte Voshaar, Thasia Woodworth, Clifton O. Bingham, Ernest H. Choy
The Journal of Rheumatology Apr 2014, 41 (4) 799-809; DOI: 10.3899/jrheum.131252

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Establishing a Core Domain Set to Measure Rheumatoid Arthritis Flares: Report of the OMERACT 11 RA Flare Workshop
Vivian P. Bykerk, Elisabeth Lie, Susan J. Bartlett, Rieke Alten, Annelies Boonen, Robin Christensen, Daniel E. Furst, Sarah Hewlett, Amye L. Leong, Anne Lyddiatt, Lyn March, James E. May, Pam Montie, Ana-Maria Orbai, Christoph Pohl, Marieke Scholte Voshaar, Thasia Woodworth, Clifton O. Bingham, Ernest H. Choy
The Journal of Rheumatology Apr 2014, 41 (4) 799-809; DOI: 10.3899/jrheum.131252
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Keywords

OUTCOME AND PROCESS ASSESSMENT
FLARE
DISEASE ACTIVITY
OMERACT FILTER
CLINICAL TRIALS
RHEUMATOID ARTHRITIS

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Disease-specific Outcomes II

  • Reconciling Healthcare Professional and Patient Perspectives in the Development of Disease Activity and Response Criteria in Connective Tissue Disease–related Interstitial Lung Diseases
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  • Establishing a Core Domain Set to Measure Rheumatoid Arthritis Flares: Report of the OMERACT 11 RA Flare Workshop
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Keywords

  • outcome and process assessment
  • FLARE
  • disease activity
  • OMERACT FILTER
  • clinical trials
  • rheumatoid arthritis

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