International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials.
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.
Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Ana-Maria
AM
Orbai
Department of Medical Humanities, Patient Research Partner, VU University Medical Centre, Amsterdam, The Netherlands.
Maarten
M
de Wit
Swedish Medical Center and University of Washington, Seattle, Washington, USA.
Philip
P
Mease
University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Judy A
JA
Shea
Sorbonne Universités, UPMC Univ Paris 06, GRC-08, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.|Rheumatology Department, Pitie-Salpétrière Hôpital, AP-HP, Paris, France.
Laure
http://orcid.org/0000-0002-4528-310X
L
Gossec
Department of Rheumatology and Immunology, Singapore General Hospital, Singapore, Singapore.
Ying Ying
http://orcid.org/0000-0001-8492-6342
YY
Leung
Royal National Hospital for Rheumatic Diseases and the University of Bath, Bath, UK.
William
W
Tillett
St. Vincent's University Hospital and the Conway Institute, University College Dublin (UCD), Dublin, Ireland.
Musaab
M
Elmamoun
Department of Dermatology, University of Utah, Salt Lake City, Utah, USA.
Kristina
K
Callis Duffin
Patient Research Partner, Toronto, Ontario, Canada.
Willemina
W
Campbell
The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark, Denmark.
Robin
R
Christensen
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Laura
L
Coates
Department of Nursing, University of the West of England, Bristol, UK.
Emma
E
Dures
Women's College Research Institute, Women's College Hospital, University of Toronto, Toronto, Ontario, Canada.
Lihi
L
Eder
St. Vincent's University Hospital and the Conway Institute, University College Dublin (UCD), Dublin, Ireland.
Oliver
O
FitzGerald
Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.
Dafna
D
Gladman
Patient Research Partner, Advisory Services, Quintiles, Durham, North Carolina, USA.|Division of Rheumatology, Duke University School of Medicine, Durham, North Carolina, USA.
Niti
N
Goel
Johns Hopkins School of Medicine, Baltimore, Maryland, USA.
Suzanne Dolwick
SD
Grieb
Department of Nursing, University of the West of England, Bristol, UK.
Sarah
S
Hewlett
The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark, Denmark.
Pil
P
Hoejgaard
Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.|Division of Rheumatology, Hacettepe University, Ankara, Turkey.
Umut
U
Kalyoncu
Patient Research Partner, Thousand Oaks, California, USA.
Chris
C
Lindsay
Royal National Hospital for Rheumatic Diseases and the University of Bath, Bath, UK.
Neil
N
McHugh
Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
Bev
B
Shea
Patient Research Partner, Cleveland, Ohio, USA.
Ingrid
I
Steinkoenig
Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA.
Vibeke
V
Strand
Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Alexis
A
Ogdie
D000293:Adolescent; D000328:Adult; D000368:Aged; D015535:Arthritis, Psoriatic / Q000150:complications* / Q000188:drug therapy* / Q000503:physiopathology; D001291:Attitude of Health Personnel; D002986:Clinical Trials as Topic; D032921:Consensus; D005221:Fatigue / Q000209:etiology; D005260:Female; D017144:Focus Groups; D006304:Health Status; D006801:Humans; D007249:Inflammation / Q000209:etiology; D038622:Internationality; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D000071066:Patient Reported Outcome Measures; D010820:Physicians; D011788:Quality of Life; D012196:Review Literature as Topic; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
Outcomes research; Psoriatic Arthritis; Qualitative research; Spondyloarthritis