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Research ArticleOMERACT 11

Updating the OMERACT Filter: Implications of Filter 2.0 to Select Outcome Instruments Through Assessment of “Truth”: Content, Face, and Construct Validity

Peter Tugwell, Maarten Boers, Maria-Antonietta D’Agostino, Dorcas Beaton, Annelies Boonen, Clifton O. Bingham III, Ernest Choy, Philip G. Conaghan, Maxime Dougados, Catia Duarte, Daniel E. Furst, Francis Guillemin, Laure Gossec, Turid Heiberg, Désirée M. van der Heijde, Sarah Hewlett, John R. Kirwan, Tore K. Kvien, Robert B. Landewé, Philip J. Mease, Mikkel Østergaard, Lee Simon, Jasvinder A. Singh, Vibeke Strand and George Wells
The Journal of Rheumatology May 2014, 41 (5) 1000-1004; DOI: https://doi.org/10.3899/jrheum.131310
Peter Tugwell
From the Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada; Departments of Epidemiology and Biostatistics, and Rheumatology, VU University Medical Center, Amsterdam, The Netherlands; Versailles-Saint Quentin En Yvelines University, Department of Rheumatology, Ambroise Paré Hospital, APHP, Boulogne-Billancourt; Paris-Descartes University, Medicine Faculty, APHP, Cochin Hospital, Rheumatology B, Paris, France; Department of Occupational Sciences and Occupational Therapy, Institute for Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht University, The Netherlands; Division of Rheumatology, Johns Hopkins University, Baltimore, Maryland, USA; Section of Rheumatology, Cardiff University School of Medicine, Cardiff, UK; Division of Musculoskeletal Disease, University of Leeds, and the UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, UK; Rheumatology Department, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal; Department of Rheumatology, Geffen School of Medicine at the University of California in Los Angeles, Los Angeles, California, USA; Université de Lorraine, EA 4360 APEMAC, Nancy; Université Pierre et Marie Curie (UPMC) - Paris 6, GRC-UMPC 08 (EEMOIS); AP-HP Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; Oslo University Hospital and Lovisenberg Diaconal University College, Oslo, Norway; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands; University of the West of England, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway; Department of Clinical Immunology and Rheumatology, Academic Medical Center, University of Amsterdam and Atrium Medical Center Heerlen, Heerlen, The Netherlands; Seattle Rheumatology Associates, Chief, Swedish Medical Center Rheumatology Research Division, Clinical Professor, University of Washington School of Medicine, Seattle, Washington; Division of Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Department of Rheumatology, Copenhagen University Hospital at Glostrup, Copenhagen, Denmark; SDG LLC, Cambridge, Massachusetts; Division of Immunology/Rheumatology, University of Alabama at Birmingham and Birmingham VA Medical Center, Birmingham, Alabama; Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA; Cardiovascular Research Methods Centre, Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada.
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  • For correspondence: tugwell.bb@uottawa.ca
Maarten Boers
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Maria-Antonietta D’Agostino
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Dorcas Beaton
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Annelies Boonen
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Clifton O. Bingham III
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Ernest Choy
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Philip G. Conaghan
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Maxime Dougados
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Catia Duarte
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Daniel E. Furst
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Francis Guillemin
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Laure Gossec
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Turid Heiberg
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Désirée M. van der Heijde
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Sarah Hewlett
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John R. Kirwan
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Tore K. Kvien
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Robert B. Landewé
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Philip J. Mease
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Mikkel Østergaard
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Lee Simon
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Jasvinder A. Singh
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Vibeke Strand
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George Wells
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    Figure 1.

    Development of a core outcome measurement set from a core domain set. From Boers M, et al. J Clin Epidemiol 2014; in press; with permission.

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    Table 1.

    Types of validity relevant to assessing “Truth”. From Felson. J Rheumatol 1993;20:531–4.

    Type of ValidityMeaning
    FaceCredibility: Is the instrument credible?
    ContentComprehensiveness: Does the instrument (or group of instruments) sufficiently sample the core domain addressed?
    ConstructDo the results of the instrument agree with expected results of other instruments measuring the same construct/concept?
    CriterionDifficult in this setting. The only external criterion available is longterm outcome.
    Does the result of the instrument predict or correlate with longterm outcome (e.g., death, disability, perhaps radiographic damage)?
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    Table 2.

    Summary of case studies.

    Outcome Topic [Author]FocusWhat are the outcome domains you are currently working with?How were the outcome instruments selected?How was face validity assessed?How was content validity assessed?How was construct validity assessed?
    Fatigue/Sleep [SH/GAW]FatigueBristol RA Fatigue ScalesFinal 20 items selected from repeated factor analysis in large RA cohort45 draft items obtained from qualitative interviews with RA patients on fatigue45 draft items obtained from qualitative interviews with RA patients on fatigueAssociations with expected related variables in comparison with performance of best existing fatigue PROM
    Gout [JS]Chronic goutPain; joint swelling; joint tenderness; patient global; activity limitationsA previously used physician-judged joint swelling Likert scale was usedPrevious use in other inflammatory arthritis conditions like rheumatoid arthritisPrevious use in other inflammatory arthritis conditions like rheumatoid arthritisCorrelation with joint tenderness, pain, and patient global
    MRI in RA [MO]Rheumatoid arthritis magnetic resonance imaging score (RAMRIS)Synovitis; bone marrow edema (osteitis); bone erosion; joint space narrowingConsensus among experts, followed by iterative testing in cross-sectional and longitudinal multireader exercises with group discussions in between Comparison with physician expert panel recommendations and with the results of an ongoing patient interview qualitative study about meaning of stiffness and the burden of PMRBy subjective evaluation of the credibility (whether the measures appeared to measure what they were supposed to) among rheumatologist, radiologists, and metrologistsBy subjective evaluation among rheumatologist, radiologists, and metrologists of whether the measures covered all aspects of the attribute to be assessed (comprehensiveness)Synovitis and bone marrow edema: By comparison with clinical and biochemical (CRP) measures of inflammation. Bone erosion and JSN: By comparison with radiography and computed tomography
    PMR [CD/JK]Polymyalgia rheumaticaPain; stiffness; function; systemic inflammationCandidate outcome measures identified for a postulated future interventional trial of an alternative to morning prednisolone for PMR through a systematic review of RCT and longitudinal observational studies in PMR to identify outcome measures reported. The instruments are generic and have not been validated for PMR specifically.Within reported studies, correlations between reported measures of outcome were sought, particularly within patient-reported measures, within laboratory measures of pathophysiology, and between these 2 groups
    Worker productivity [AB/DB]Instruments to measure presenteeism (being at work while ill)Work outcomes in inflammatory rheumatic disease (and osteoarthritis)A systematic review of the literature to identify instruments that measure presenteeism in studies on patients with inflammatory disease (or osteoarthritis)Careful assessment of (1) the stated objective to develop the instrument; (2) the instrument itself.
    ↓
    Then classifying instruments as (1) those aiming to quantify the “productivity for the workplace” vs those aiming to assess the “difficulty or ability of the patients;” and (2) either multidimensional (usually addressing difficulty) or single item (most frequently addressing productivity)
    (1) For the multidimensional instruments, content was linked to the nearest fitting ICF category; (2) for the single item instruments: (a) survey among clinicians, and economic researchers: does this instrument assess productivity, ability/difficulty or both? (b) cognitive debriefing: do patients understand the construct? (further non-English–speaking culture debriefing planned)(1) Against measure of disease burden: disease activity, activities, other social roles, and (2) against other measures of work outcome; either presenteeism or sick leave
    • RA: rheumatoid arthritis; PROM: patient-reported outcome measures; CRP: C-reactive protein; JSN: joint space narrowing; PMR: polymyalgia rheumatica; RCT: randomized controlled trial; ICF: International Classification of Functioning, Disability, and Health.

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    Table 3.

    Main issues emerging from breakout groups in establishing face, content, and construct validity requiring clarification and resolution for Filter 2.0.

    General issuesAre the criteria the same for each domain within instruments that cross domains?
    When and how to involve patients (especially in face and content)?
    When and how to involve others in addition to patients, clinicians, researchers, and approval agencies — e.g., general public, policy makers, economists, the press
    Process issuesCan one get some Core Domain Instruments approved before others? E.g., Does core set development come to a stop if 1 or more Core Domains does not have a validated instrument?
    There should be provision for updating or revision of Core Outcome sets as further data accumulate
    Face validityHow many of each group need to assess this?
    Content validityShould we always match subdomains and /or link to the ICF as external framework for “what to measure”?
    Construct validityShould there be a standard set of constructs?
    • ICF: International Classification of Functioning, Disability and Health.

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The Journal of Rheumatology
Vol. 41, Issue 5
1 May 2014
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Updating the OMERACT Filter: Implications of Filter 2.0 to Select Outcome Instruments Through Assessment of “Truth”: Content, Face, and Construct Validity
Peter Tugwell, Maarten Boers, Maria-Antonietta D’Agostino, Dorcas Beaton, Annelies Boonen, Clifton O. Bingham, Ernest Choy, Philip G. Conaghan, Maxime Dougados, Catia Duarte, Daniel E. Furst, Francis Guillemin, Laure Gossec, Turid Heiberg, Désirée M. van der Heijde, Sarah Hewlett, John R. Kirwan, Tore K. Kvien, Robert B. Landewé, Philip J. Mease, Mikkel Østergaard, Lee Simon, Jasvinder A. Singh, Vibeke Strand, George Wells
The Journal of Rheumatology May 2014, 41 (5) 1000-1004; DOI: 10.3899/jrheum.131310

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Updating the OMERACT Filter: Implications of Filter 2.0 to Select Outcome Instruments Through Assessment of “Truth”: Content, Face, and Construct Validity
Peter Tugwell, Maarten Boers, Maria-Antonietta D’Agostino, Dorcas Beaton, Annelies Boonen, Clifton O. Bingham, Ernest Choy, Philip G. Conaghan, Maxime Dougados, Catia Duarte, Daniel E. Furst, Francis Guillemin, Laure Gossec, Turid Heiberg, Désirée M. van der Heijde, Sarah Hewlett, John R. Kirwan, Tore K. Kvien, Robert B. Landewé, Philip J. Mease, Mikkel Østergaard, Lee Simon, Jasvinder A. Singh, Vibeke Strand, George Wells
The Journal of Rheumatology May 2014, 41 (5) 1000-1004; DOI: 10.3899/jrheum.131310
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Keywords

OMERACT
OUTCOME AND PROCESS ASSESSMENT
CONTENT VALIDITY
RANDOMIZED CONTROLLED TRIALS
CONSTRUCT VALIDITY
FACE VALIDITY

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OMERACT 11

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  • Updating the OMERACT Filter: Implications for Imaging and Soluble Biomarkers
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The OMERACT Filter 2.0

  • Can We Decide Which Outcomes Should Be Measured in Every Clinical Trial? A Scoping Review of the Existing Conceptual Frameworks and Processes to Develop Core Outcome Sets
  • Updating the OMERACT Filter at OMERACT 11
  • Updating the OMERACT Filter: Core Areas as a Basis for Defining Core Outcome Sets
Show more The OMERACT Filter 2.0

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  • CONTENT VALIDITY
  • RANDOMIZED CONTROLLED TRIALS
  • CONSTRUCT VALIDITY
  • FACE VALIDITY

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