PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials

doi:10.3899/jrheum.181077

Review

. 2019 Aug;46(8):990-995.

doi: 10.3899/jrheum.181077. Epub 2018 Dec 15.

PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials

Ana-Maria Orbai^{1

2}, Richard Holland^{3

4}, Ying Ying Leung^{3

4}, William Tillett^{3

4}, Niti Goel^{3

4}, Robin Christensen^{3

4}, Neil McHugh^{3

4}, Laure Gossec^{3

4}, Maarten de Wit^{3

4}, Pil Højgaard^{3

4}, Laura C Coates^{3

4}, Philip J Mease^{3

4}, Julie Birt^{3

4}, Lara Fallon^{3

4}, Oliver FitzGerald^{3

4}, Alexis Ogdie^{3

4}, Beverly Shea^{3

4}, Vibeke Strand^{3

4}, Kristina Callis Duffin^{3

4}, Peter Tugwell^{3

4}, Dorcas Beaton^{3

4}, Dafna D Gladman^{3

4}

Affiliations

¹ From the Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore; Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Kezar Life Sciences, South San Francisco; Division of Immunology, Stanford University, Palo Alto, California; Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine, Seattle, Washington; Global Patient Outcomes and Real World Evidence, Eli Lilly and Co., Indianapolis, Indiana; University of Pennsylvania, Philadelphia, Pennsylvania; Department of Dermatology, University of Utah, Salt Lake City, Utah, USA; Royal Prince Alfred Hospital Medical Centre, Sydney, Australia; Department of Rheumatology and Immunology, Singapore General Hospital, Singapore; Royal National Hospital for Rheumatic Diseases, Bath; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Musculoskeletal Statistics Unit: The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Department of Rheumatology, Odense University Hospital, Odense, Denmark; Sorbonne Université; Rheumatology Department, Pitié Salpêtrière Hospital, AP-HP, Paris, France; VU Medical Centre, Amsterdam, the Netherlands; Global Medical Affairs, Pfizer Inc., Montreal, Quebec; Clinical Epidemiology Program, Ottawa Hospital Research Institute; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Musculoskeletal Health and Outcomes Research, St. Michael's Hospital and Institute for Work and Health; Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, Institute for Health Policy Management and Evaluation, University of Toronto; University of Toronto; Krembil Research Institute; Psoriatic Arthritis Program, University Health Network, Toronto, Ontario, Canada; Department of Rheumatology, St. Vincent's University Hospital and Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland. aorbai1@jhmi.edu.
² A.M. Orbai, MD, MHS, Division of Rheumatology, Johns Hopkins University School of Medicine; R. Holland, MB, ChB, Royal Prince Alfred Hospital Medical Centre; Y.Y. Leung, MD, PhD, Department of Rheumatology and Immunology, Singapore General Hospital; W. Tillett, BSc, MBChB, PhD, MRCP, Royal National Hospital for Rheumatic Diseases; N. Goel, MD, Patient Research Partner, Department of Medicine, Duke University School of Medicine, and Kezar Life Sciences; R. Christensen, BSc, MSc, PhD, Professor of Biostatistics and Clinical Epidemiology, and Musculoskeletal Statistics Unit: The Parker Institute, Bispebjerg and Frederiksberg Hospital, and Department of Rheumatology, Odense University Hospital; N. McHugh, MBChB, MD, FRCP, FRCPath, Royal National Hospital for Rheumatic Diseases; L. Gossec, MD, PhD, Sorbonne Université, and Rheumatology Department, Pitié Salpêtrière Hospital, AP-HP; M. de Wit, PhD, Patient Research Partner, VU Medical Centre; P. Højgaard, MD, The Parker Institute, Bispebjerg and Frederiksberg Hospital; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford; P.J. Mease, MD, Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine; J. Birt, PharmD, Global Patient Outcomes and Real World Evidence, and Eli Lilly and Co.; L. Fallon, PhD, Global Medical Affairs, Pfizer Inc.; O. FitzGerald, MD, FRCPI, FRCP(UK), Newman Clinical Research Professor, Department of Rheumatology, St. Vincent's University Hospital, and Conway Institute for Biomolecular Research, University College Dublin; A. Ogdie, MD, MSCE, University of Pennsylvania; B. Shea, PhD, Clinical Epidemiology Program, Ottawa Hospital Research Institute, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; V. Strand, MD, Biopharmaceutical Consultant; K. Callis Duffin, MD, Department of Dermatology, University of Utah; P. Tugwell, Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, and Clinical Epidemiology Program, Ottawa Hospital Research Institute; D. Beaton, BScOT, PhD, Musculoskeletal Health and Outcomes Research, St. Michael's Hospital and Institute for Work and Health, and Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, and the Institute for Health Policy Management and Evaluation, University of Toronto; D.D. Gladman, MD, FRCPC, Professor of Medicine, University of Toronto, and Senior Scientist, Krembil Research Institute, and Director, Psoriatic Arthritis Program, University Health Network. aorbai1@jhmi.edu.
³ From the Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore; Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Kezar Life Sciences, South San Francisco; Division of Immunology, Stanford University, Palo Alto, California; Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine, Seattle, Washington; Global Patient Outcomes and Real World Evidence, Eli Lilly and Co., Indianapolis, Indiana; University of Pennsylvania, Philadelphia, Pennsylvania; Department of Dermatology, University of Utah, Salt Lake City, Utah, USA; Royal Prince Alfred Hospital Medical Centre, Sydney, Australia; Department of Rheumatology and Immunology, Singapore General Hospital, Singapore; Royal National Hospital for Rheumatic Diseases, Bath; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Musculoskeletal Statistics Unit: The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Department of Rheumatology, Odense University Hospital, Odense, Denmark; Sorbonne Université; Rheumatology Department, Pitié Salpêtrière Hospital, AP-HP, Paris, France; VU Medical Centre, Amsterdam, the Netherlands; Global Medical Affairs, Pfizer Inc., Montreal, Quebec; Clinical Epidemiology Program, Ottawa Hospital Research Institute; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Musculoskeletal Health and Outcomes Research, St. Michael's Hospital and Institute for Work and Health; Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, Institute for Health Policy Management and Evaluation, University of Toronto; University of Toronto; Krembil Research Institute; Psoriatic Arthritis Program, University Health Network, Toronto, Ontario, Canada; Department of Rheumatology, St. Vincent's University Hospital and Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland.
⁴ A.M. Orbai, MD, MHS, Division of Rheumatology, Johns Hopkins University School of Medicine; R. Holland, MB, ChB, Royal Prince Alfred Hospital Medical Centre; Y.Y. Leung, MD, PhD, Department of Rheumatology and Immunology, Singapore General Hospital; W. Tillett, BSc, MBChB, PhD, MRCP, Royal National Hospital for Rheumatic Diseases; N. Goel, MD, Patient Research Partner, Department of Medicine, Duke University School of Medicine, and Kezar Life Sciences; R. Christensen, BSc, MSc, PhD, Professor of Biostatistics and Clinical Epidemiology, and Musculoskeletal Statistics Unit: The Parker Institute, Bispebjerg and Frederiksberg Hospital, and Department of Rheumatology, Odense University Hospital; N. McHugh, MBChB, MD, FRCP, FRCPath, Royal National Hospital for Rheumatic Diseases; L. Gossec, MD, PhD, Sorbonne Université, and Rheumatology Department, Pitié Salpêtrière Hospital, AP-HP; M. de Wit, PhD, Patient Research Partner, VU Medical Centre; P. Højgaard, MD, The Parker Institute, Bispebjerg and Frederiksberg Hospital; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford; P.J. Mease, MD, Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine; J. Birt, PharmD, Global Patient Outcomes and Real World Evidence, and Eli Lilly and Co.; L. Fallon, PhD, Global Medical Affairs, Pfizer Inc.; O. FitzGerald, MD, FRCPI, FRCP(UK), Newman Clinical Research Professor, Department of Rheumatology, St. Vincent's University Hospital, and Conway Institute for Biomolecular Research, University College Dublin; A. Ogdie, MD, MSCE, University of Pennsylvania; B. Shea, PhD, Clinical Epidemiology Program, Ottawa Hospital Research Institute, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; V. Strand, MD, Biopharmaceutical Consultant; K. Callis Duffin, MD, Department of Dermatology, University of Utah; P. Tugwell, Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, and Clinical Epidemiology Program, Ottawa Hospital Research Institute; D. Beaton, BScOT, PhD, Musculoskeletal Health and Outcomes Research, St. Michael's Hospital and Institute for Work and Health, and Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, and the Institute for Health Policy Management and Evaluation, University of Toronto; D.D. Gladman, MD, FRCPC, Professor of Medicine, University of Toronto, and Senior Scientist, Krembil Research Institute, and Director, Psoriatic Arthritis Program, University Health Network.

PMID: 30554154
PMCID: PMC6571063
DOI: 10.3899/jrheum.181077

Review

PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials

Ana-Maria Orbai et al. J Rheumatol. 2019 Aug.

. 2019 Aug;46(8):990-995.

doi: 10.3899/jrheum.181077. Epub 2018 Dec 15.

Authors

Affiliations

¹ From the Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore; Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Kezar Life Sciences, South San Francisco; Division of Immunology, Stanford University, Palo Alto, California; Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine, Seattle, Washington; Global Patient Outcomes and Real World Evidence, Eli Lilly and Co., Indianapolis, Indiana; University of Pennsylvania, Philadelphia, Pennsylvania; Department of Dermatology, University of Utah, Salt Lake City, Utah, USA; Royal Prince Alfred Hospital Medical Centre, Sydney, Australia; Department of Rheumatology and Immunology, Singapore General Hospital, Singapore; Royal National Hospital for Rheumatic Diseases, Bath; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Musculoskeletal Statistics Unit: The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Department of Rheumatology, Odense University Hospital, Odense, Denmark; Sorbonne Université; Rheumatology Department, Pitié Salpêtrière Hospital, AP-HP, Paris, France; VU Medical Centre, Amsterdam, the Netherlands; Global Medical Affairs, Pfizer Inc., Montreal, Quebec; Clinical Epidemiology Program, Ottawa Hospital Research Institute; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Musculoskeletal Health and Outcomes Research, St. Michael's Hospital and Institute for Work and Health; Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, Institute for Health Policy Management and Evaluation, University of Toronto; University of Toronto; Krembil Research Institute; Psoriatic Arthritis Program, University Health Network, Toronto, Ontario, Canada; Department of Rheumatology, St. Vincent's University Hospital and Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland. aorbai1@jhmi.edu.
² A.M. Orbai, MD, MHS, Division of Rheumatology, Johns Hopkins University School of Medicine; R. Holland, MB, ChB, Royal Prince Alfred Hospital Medical Centre; Y.Y. Leung, MD, PhD, Department of Rheumatology and Immunology, Singapore General Hospital; W. Tillett, BSc, MBChB, PhD, MRCP, Royal National Hospital for Rheumatic Diseases; N. Goel, MD, Patient Research Partner, Department of Medicine, Duke University School of Medicine, and Kezar Life Sciences; R. Christensen, BSc, MSc, PhD, Professor of Biostatistics and Clinical Epidemiology, and Musculoskeletal Statistics Unit: The Parker Institute, Bispebjerg and Frederiksberg Hospital, and Department of Rheumatology, Odense University Hospital; N. McHugh, MBChB, MD, FRCP, FRCPath, Royal National Hospital for Rheumatic Diseases; L. Gossec, MD, PhD, Sorbonne Université, and Rheumatology Department, Pitié Salpêtrière Hospital, AP-HP; M. de Wit, PhD, Patient Research Partner, VU Medical Centre; P. Højgaard, MD, The Parker Institute, Bispebjerg and Frederiksberg Hospital; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford; P.J. Mease, MD, Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine; J. Birt, PharmD, Global Patient Outcomes and Real World Evidence, and Eli Lilly and Co.; L. Fallon, PhD, Global Medical Affairs, Pfizer Inc.; O. FitzGerald, MD, FRCPI, FRCP(UK), Newman Clinical Research Professor, Department of Rheumatology, St. Vincent's University Hospital, and Conway Institute for Biomolecular Research, University College Dublin; A. Ogdie, MD, MSCE, University of Pennsylvania; B. Shea, PhD, Clinical Epidemiology Program, Ottawa Hospital Research Institute, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; V. Strand, MD, Biopharmaceutical Consultant; K. Callis Duffin, MD, Department of Dermatology, University of Utah; P. Tugwell, Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, and Clinical Epidemiology Program, Ottawa Hospital Research Institute; D. Beaton, BScOT, PhD, Musculoskeletal Health and Outcomes Research, St. Michael's Hospital and Institute for Work and Health, and Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, and the Institute for Health Policy Management and Evaluation, University of Toronto; D.D. Gladman, MD, FRCPC, Professor of Medicine, University of Toronto, and Senior Scientist, Krembil Research Institute, and Director, Psoriatic Arthritis Program, University Health Network. aorbai1@jhmi.edu.
³ From the Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore; Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Kezar Life Sciences, South San Francisco; Division of Immunology, Stanford University, Palo Alto, California; Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine, Seattle, Washington; Global Patient Outcomes and Real World Evidence, Eli Lilly and Co., Indianapolis, Indiana; University of Pennsylvania, Philadelphia, Pennsylvania; Department of Dermatology, University of Utah, Salt Lake City, Utah, USA; Royal Prince Alfred Hospital Medical Centre, Sydney, Australia; Department of Rheumatology and Immunology, Singapore General Hospital, Singapore; Royal National Hospital for Rheumatic Diseases, Bath; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Musculoskeletal Statistics Unit: The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Department of Rheumatology, Odense University Hospital, Odense, Denmark; Sorbonne Université; Rheumatology Department, Pitié Salpêtrière Hospital, AP-HP, Paris, France; VU Medical Centre, Amsterdam, the Netherlands; Global Medical Affairs, Pfizer Inc., Montreal, Quebec; Clinical Epidemiology Program, Ottawa Hospital Research Institute; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Musculoskeletal Health and Outcomes Research, St. Michael's Hospital and Institute for Work and Health; Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, Institute for Health Policy Management and Evaluation, University of Toronto; University of Toronto; Krembil Research Institute; Psoriatic Arthritis Program, University Health Network, Toronto, Ontario, Canada; Department of Rheumatology, St. Vincent's University Hospital and Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland.
⁴ A.M. Orbai, MD, MHS, Division of Rheumatology, Johns Hopkins University School of Medicine; R. Holland, MB, ChB, Royal Prince Alfred Hospital Medical Centre; Y.Y. Leung, MD, PhD, Department of Rheumatology and Immunology, Singapore General Hospital; W. Tillett, BSc, MBChB, PhD, MRCP, Royal National Hospital for Rheumatic Diseases; N. Goel, MD, Patient Research Partner, Department of Medicine, Duke University School of Medicine, and Kezar Life Sciences; R. Christensen, BSc, MSc, PhD, Professor of Biostatistics and Clinical Epidemiology, and Musculoskeletal Statistics Unit: The Parker Institute, Bispebjerg and Frederiksberg Hospital, and Department of Rheumatology, Odense University Hospital; N. McHugh, MBChB, MD, FRCP, FRCPath, Royal National Hospital for Rheumatic Diseases; L. Gossec, MD, PhD, Sorbonne Université, and Rheumatology Department, Pitié Salpêtrière Hospital, AP-HP; M. de Wit, PhD, Patient Research Partner, VU Medical Centre; P. Højgaard, MD, The Parker Institute, Bispebjerg and Frederiksberg Hospital; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford; P.J. Mease, MD, Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine; J. Birt, PharmD, Global Patient Outcomes and Real World Evidence, and Eli Lilly and Co.; L. Fallon, PhD, Global Medical Affairs, Pfizer Inc.; O. FitzGerald, MD, FRCPI, FRCP(UK), Newman Clinical Research Professor, Department of Rheumatology, St. Vincent's University Hospital, and Conway Institute for Biomolecular Research, University College Dublin; A. Ogdie, MD, MSCE, University of Pennsylvania; B. Shea, PhD, Clinical Epidemiology Program, Ottawa Hospital Research Institute, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; V. Strand, MD, Biopharmaceutical Consultant; K. Callis Duffin, MD, Department of Dermatology, University of Utah; P. Tugwell, Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, and Clinical Epidemiology Program, Ottawa Hospital Research Institute; D. Beaton, BScOT, PhD, Musculoskeletal Health and Outcomes Research, St. Michael's Hospital and Institute for Work and Health, and Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, and the Institute for Health Policy Management and Evaluation, University of Toronto; D.D. Gladman, MD, FRCPC, Professor of Medicine, University of Toronto, and Senior Scientist, Krembil Research Institute, and Director, Psoriatic Arthritis Program, University Health Network.

PMID: 30554154
PMCID: PMC6571063
DOI: 10.3899/jrheum.181077

Abstract

Objective: The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT) psoriatic arthritis (PsA) working group is developing a Core Outcome Measurement Set for PsA clinical trials [randomized controlled trials (RCT) and longitudinal observational studies (LOS)] using the OMERACT Filter 2.1 instrument selection algorithm. Our objective was to assess the Psoriatic Arthritis Impact of Disease questionnaire (PsAID12) for the measurement of the core domain PsA-specific health-related quality of life (HRQOL).

Methods: PsAID12 measurement property evidence gathered in a systematic literature review, and additional analyses conducted in LOS, were used to inform a consensus process. Analyses that had not been published were independently reviewed by the OMERACT technical advisory group. Data and process were presented, discussed in breakout groups, and voted on at the OMERACT conference (Terrigal, Australia, May 2018).

Results: PsAID12 fulfilled the green (good to go) OMERACT standards for domain match, feasibility, reliability, and construct/longitudinal construct validity. Discrimination and thresholds of meaning were amber (caution but good enough to go forward). The overall working group recommendation was amber/provisional endorsement of PsAID12 for measuring PsA-specific HRQOL in RCT and LOS. Of 96 participants who voted at the PsA OMERACT workshop, 87.5% (84) voted "yes" to endorse this recommendation; 14 of the 96 were patient research partners (PRP) and 93% of them (13) voted "yes"; 82 participants were not PRP and 87% of them (71) voted "yes."

Conclusion: At OMERACT 2018, PsAID12 was the first patient-reported outcome measure provisionally endorsed as a core outcome measure for disease-specific HRQOL in PsA clinical trials. PsAID12 discrimination and improvement thresholds will be studied in future RCT.

Keywords: CORE SET; GRAPPA; OMERACT; OUTCOME MEASURES; PSORIATIC ARTHRITIS.

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Figures

**Figure 1.**
The OMERACT Filter 2.1 Instrument selection algorithm is represented at the left (OMERACT handbook). The COMPACT workflow through OMERACT Filter 2.1 is represented at the right. The four signaling questions must be addressed in OMERACT Filter 2.1 instrument selection (items 1–4) in the left part of the figure. Following the OMERACT process stakeholders provide input initially into domain match and feasibility, and subsequently into the approach and results of evaluation of additional measurement properties, as well as the final voting for inclusion as core outcome measure(s). For each domain and candidate outcome measure the OFISA Filter 2.1 is applied until a core outcome measure has been selected. The process is repeated for each core domain. Once each core domain has at least one corresponding core outcome measurement instrument the PsA Core Outcome Measurement Set is complete. Abbreviations: OMERACT Outcome Measures in Rheumatology, GRAPPA Group for Research and Assessment of Psoriasis and Psoriatic Arthritis, COMPACT Core Outcome Measures in Psoriatic Arthritis, LOS longitudinal observational studies, PsA psoriatic arthritis, SLR systematic literature review, RCT randomized controlled trials, COSMIN Consensus based standards for the assessment of health measurement instruments, TAG OMERACT Technical Advisory Group.

**Figure 2.**
OMERACT Summary of evidence for measurement properties of PsAID12. Color designates quality of evidence: dark grey stands for green=good methods used, use this evidence; light grey stands for amber=some cautions but we will use this evidence. In the rating row, color designates overall evidence-based instrument rating for the core instrument set: dark grey stands for green= at least 2 pieces of evidence with good methods and consistent findings of adequate or better performance; light grey stands for amber=in between green and red; red= inadequate performance in at least 1 study that used good methods, white=no evidence. Arithmetic signs designate the performance of the instrument according to that study (for each measurement property studied): “+”adequate or better performance, “+/−”equivocal performance, “-”less than adequate/poor performance. Abbreviations: TAG OMERACT Technical advisory group

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References

1. Orbai AM, de Wit M, Mease P, Shea JA, Gossec L, Leung YY et al. International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials. Ann Rheum Dis 2017;76: 673–680. - PMC - PubMed
1. Orbai AM, de Wit M, Mease PJ, Callis Duffin K, Elmamoun M, Tillett W, et al. Updating the Psoriatic Arthritis (PsA) Core Domain Set: A Report from the PsA Workshop at OMERACT 2016. J Rheumatol. 2017; 44:1522–1528. - PMC - PubMed
1. Boers M, Kirwan JR, Tugwell P, Beaton D, Bingham CO III, Conaghan PG, et al. The OMERACT Handbook. [Internet. Accessed August 24, 2018] Available from: https://omeract.org/resources
1. Boers M, Kirwan JR, Wells G, Beaton D, Gossec L, d’Agostino MA, et al. Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. J Clin Epidemiol 2014;67:745–53 - PubMed
1. Tillett W, Orbai AM, Ogdie A, Leung YY, Strand V, Gladman DD, et al. GRAPPA-OMERACT initiative to standardise outcomes in psoriatic arthritis clinical trials and longitudinal observational studies. Ann Rheum Dis. 2018. May;77:e23. - PubMed

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[1] Orbai AM, de Wit M, Mease P, Shea JA, Gossec L, Leung YY et al. International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials. Ann Rheum Dis 2017;76: 673–680. - PMC - PubMed

[2] Orbai AM, de Wit M, Mease P, Shea JA, Gossec L, Leung YY et al. International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials. Ann Rheum Dis 2017;76: 673–680. - PMC - PubMed

[3] Orbai AM, de Wit M, Mease PJ, Callis Duffin K, Elmamoun M, Tillett W, et al. Updating the Psoriatic Arthritis (PsA) Core Domain Set: A Report from the PsA Workshop at OMERACT 2016. J Rheumatol. 2017; 44:1522–1528. - PMC - PubMed

[4] Orbai AM, de Wit M, Mease PJ, Callis Duffin K, Elmamoun M, Tillett W, et al. Updating the Psoriatic Arthritis (PsA) Core Domain Set: A Report from the PsA Workshop at OMERACT 2016. J Rheumatol. 2017; 44:1522–1528. - PMC - PubMed

[5] Boers M, Kirwan JR, Tugwell P, Beaton D, Bingham CO III, Conaghan PG, et al. The OMERACT Handbook. [Internet. Accessed August 24, 2018] Available from: https://omeract.org/resources

[6] Boers M, Kirwan JR, Tugwell P, Beaton D, Bingham CO III, Conaghan PG, et al. The OMERACT Handbook. [Internet. Accessed August 24, 2018] Available from: https://omeract.org/resources

[7] Boers M, Kirwan JR, Wells G, Beaton D, Gossec L, d’Agostino MA, et al. Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. J Clin Epidemiol 2014;67:745–53 - PubMed

[8] Boers M, Kirwan JR, Wells G, Beaton D, Gossec L, d’Agostino MA, et al. Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. J Clin Epidemiol 2014;67:745–53 - PubMed

[9] Tillett W, Orbai AM, Ogdie A, Leung YY, Strand V, Gladman DD, et al. GRAPPA-OMERACT initiative to standardise outcomes in psoriatic arthritis clinical trials and longitudinal observational studies. Ann Rheum Dis. 2018. May;77:e23. - PubMed

[10] Tillett W, Orbai AM, Ogdie A, Leung YY, Strand V, Gladman DD, et al. GRAPPA-OMERACT initiative to standardise outcomes in psoriatic arthritis clinical trials and longitudinal observational studies. Ann Rheum Dis. 2018. May;77:e23. - PubMed

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PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials

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PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials

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