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Extended report
International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials
  1. Ana-Maria Orbai1,
  2. Maarten de Wit2,
  3. Philip Mease3,
  4. Judy A Shea4,
  5. Laure Gossec5,6,
  6. Ying Ying Leung7,
  7. William Tillett8,
  8. Musaab Elmamoun9,
  9. Kristina Callis Duffin10,
  10. Willemina Campbell11,
  11. Robin Christensen12,
  12. Laura Coates13,
  13. Emma Dures14,
  14. Lihi Eder15,
  15. Oliver FitzGerald9,
  16. Dafna Gladman16,
  17. Niti Goel17,18,
  18. Suzanne Dolwick Grieb19,
  19. Sarah Hewlett14,
  20. Pil Hoejgaard12,
  21. Umut Kalyoncu1,20,
  22. Chris Lindsay21,
  23. Neil McHugh8,
  24. Bev Shea22,
  25. Ingrid Steinkoenig23,
  26. Vibeke Strand24,
  27. Alexis Ogdie25
  1. 1Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
  2. 2Department of Medical Humanities, Patient Research Partner, VU University Medical Centre, Amsterdam, The Netherlands
  3. 3Swedish Medical Center and University of Washington, Seattle, Washington, USA
  4. 4University of Pennsylvania, Philadelphia, Pennsylvania, USA
  5. 5Sorbonne Universités, UPMC Univ Paris 06, GRC-08, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France
  6. 6Rheumatology Department, Pitie-Salpétrière Hôpital, AP-HP, Paris, France
  7. 7Department of Rheumatology and Immunology, Singapore General Hospital, Singapore, Singapore
  8. 8Royal National Hospital for Rheumatic Diseases and the University of Bath, Bath, UK
  9. 9St. Vincent's University Hospital and the Conway Institute, University College Dublin (UCD), Dublin, Ireland
  10. 10Department of Dermatology, University of Utah, Salt Lake City, Utah, USA
  11. 11Patient Research Partner, Toronto, Ontario, Canada
  12. 12The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark, Denmark
  13. 13Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK
  14. 14Department of Nursing, University of the West of England, Bristol, UK
  15. 15Women's College Research Institute, Women's College Hospital, University of Toronto, Toronto, Ontario, Canada
  16. 16Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada
  17. 17Patient Research Partner, Advisory Services, Quintiles, Durham, North Carolina, USA
  18. 18Division of Rheumatology, Duke University School of Medicine, Durham, North Carolina, USA
  19. 19Johns Hopkins School of Medicine, Baltimore, Maryland, USA
  20. 20Division of Rheumatology, Hacettepe University, Ankara, Turkey
  21. 21Patient Research Partner, Thousand Oaks, California, USA
  22. 22Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada
  23. 23Patient Research Partner, Cleveland, Ohio, USA
  24. 24Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA
  25. 25Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
  1. Correspondence to Dr Ana-Maria Orbai, Johns Hopkins Arthritis Center, 5501 Hopkins Bayview Circle, AAC-1B, Baltimore, MD 21224, USA; aorbai1{at}jhmi.edu

Abstract

Objective To identify a core set of domains (outcomes) to be measured in psoriatic arthritis (PsA) clinical trials that represent both patients' and physicians' priorities.

Methods We conducted (1) a systematic literature review (SLR) of domains assessed in PsA; (2) international focus groups to identify domains important to people with PsA; (3) two international surveys with patients and physicians to prioritise domains; (4) an international face-to-face meeting with patients and physicians using the nominal group technique method to agree on the most important domains; and (5) presentation and votes at the Outcome Measures in Rheumatology (OMERACT) conference in May 2016. All phases were performed in collaboration with patient research partners.

Results We identified 39 unique domains through the SLR (24 domains) and international focus groups (34 domains). 50 patients and 75 physicians rated domain importance. During the March 2016 consensus meeting, 12 patients and 12 physicians agreed on 10 candidate domains. Then, 49 patients and 71 physicians rated these domains' importance. Five were important to >70% of both groups: musculoskeletal disease activity, skin disease activity, structural damage, pain and physical function. Fatigue and participation were important to >70% of patients. Patient global and systemic inflammation were important to >70% of physicians. The updated PsA core domain set endorsed by 90% of OMERACT 2016 participants includes musculoskeletal disease activity, skin disease activity, pain, patient global, physical function, health-related quality of life, fatigue and systemic inflammation.

Conclusions The updated PsA core domain set incorporates patients' and physicians' priorities and evolving PsA research. Next steps include identifying outcome measures that adequately assess these domains.

  • Psoriatic Arthritis
  • Outcomes research
  • Qualitative research
  • Spondyloarthritis

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Footnotes

  • Handling editor Tore K Kvien

  • Correction notice This article has been corrected since it published Online First. The acknowledgements section has been updated.

  • Contributors All authors participated in the conception, design and analyses of the study. A-MO and AO drafted the manuscript and are guarantors. All authors contributed to the interpretation of results and approved the final version of the manuscript.

  • Funding A-MO was supported in part by a Scientist Development Award from the Rheumatology Research Foundation and the Johns Hopkins Arthritis Center Discovery Fund. AO was supported by research grant K23 AR063764 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This work was supported in part by research grant P30-AR053503 (RDRCC Human Subjects Research Core) from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Camille J. Morgan Arthritis Research and Education Fund. The international focus group study was supported by research grants from Celgene and Janssen. The nominal group technique meeting was supported by research grants from Abbvie, Celgene and Pfizer. The UK focus group study was funded by the National Institute for Health Research (Programme Grants for Applied Research, early detection to improve outcome in patients with undiagnosed psoriatic arthritis, RP-PG-1212-20007). Attendance of working group fellows and patient research partners to the Outcome Measures in Rheumatology (OMERACT) conference was supported with workshop funds from Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and OMERACT.

  • Disclaimer The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health.

  • Competing interests A-MO reports grants from Celgene and Janssen (to Johns Hopkins University), during the conduct of the study; consulting fees from Janssen, outside the submitted work. MdW reports grants from Celgene and Janssen (to Johns Hopkins University), during the conduct of the study; personal fees from Novartis, personal fees from BMS, outside the submitted work. PM reports grants and other from AbbVie, grants and other from Amgen, grants and other from Bristol Myers Squibb, grants and other from Celgene, other from Crescendo, other from Corrona, other from Demira, other from Genentech, grants and other from Janssen, grants and other from Lilly, other from Merck, grants and other from Novartis, grants and other from Pfizer, grants and other from Sun, grants and other from UCB, other from Zynerba, during the conduct of the study. WT reports grants, consulting and speaker fees from Abbvie, Pfizer, UCB, Novartis and Celgene. OFG reports grants and/or consulting fees from Abbvie, Pfizer, BMS, Celgene, Janssen, Novartis, UCB, Lilly. NG reports she is a full-time employee of Quintiles, Inc. PH reports personal fees from Celgene, outside the submitted work. NMcH reports grants from UK Government to Host Institution, during the conduct of the study. MdW and VS are members of the executive of OMERACT, an organisation that develops outcome measures in rheumatology and receives arms-length funding from 36 companies.

  • Ethics approval The focus group studies were approved by the Johns Hopkins Institutional Review Board (IRB), Baltimore, Maryland, USA (NA_00066663), National Research Ethics Service Committee North West—Haydock, UK (REC reference: 15/NW/0609) and by local ethics committees at each site. The Delphi procedure was approved or considered exempt by the IRBs or ethics boards at the University of Pennsylvania (Philadelphia, Pennsylvania, USA), Johns Hopkins (Baltimore, Maryland, USA) (IRB00093948), St. Vincent's University Hospital Research and Ethics committee (Dublin, Ireland), SingHealth Centralized IRB (Singapore), and Comité pour la Protection des Personnes Ile de France VI, Hopital Pitié-Salpétriere (Paris, France).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Data from this study will be shared upon request. Contact the corresponding author for such inquiries.

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