International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials

Ana-Maria Orbai, Maarten de Wit, Philip Mease, Judy A. Shea, Laure Gossec, Ying Ying Leung, William Tillett, Musaab Elmamoun, Kristina Callis Duffin, Willemina Campbell, Robin Christensen, Laura Coates, Emma Dures, Lihi Eder, Oliver FitzGerald, Dafna Gladman, Niti Goel, Suzanne Grieb, Sarah Hewlett, Pil Hoejgaard & 7 others Umut Kalyoncu, Chris Lindsay, Neil McHugh, Bev Shea, Ingrid Steinkoenig, Vibeke Strand, Alexis Ogdie

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
JournalAnnals of the Rheumatic Diseases
DOIs
StateAccepted/In press - Sep 9 2016

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Psoriatic Arthritis
Consensus
Clinical Trials
Physicians
Skin
Fatigue of materials
Musculoskeletal Diseases
Focus Groups
Health
Skin Diseases
Fatigue
Outcome Assessment (Health Care)
Inflammation
Pain
Rheumatology
Research
Quality of Life

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology
  • Medicine(all)
  • Biochemistry, Genetics and Molecular Biology(all)

Cite this

International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials. / Orbai, Ana-Maria; de Wit, Maarten; Mease, Philip; Shea, Judy A.; Gossec, Laure; Leung, Ying Ying; Tillett, William; Elmamoun, Musaab; Duffin, Kristina Callis; Campbell, Willemina; Christensen, Robin; Coates, Laura; Dures, Emma; Eder, Lihi; FitzGerald, Oliver; Gladman, Dafna; Goel, Niti; Grieb, Suzanne; Hewlett, Sarah; Hoejgaard, Pil; Kalyoncu, Umut; Lindsay, Chris; McHugh, Neil; Shea, Bev; Steinkoenig, Ingrid; Strand, Vibeke; Ogdie, Alexis.

In: Annals of the Rheumatic Diseases, 09.09.2016.

Research output: Contribution to journalArticle

Orbai, A-M, de Wit, M, Mease, P, Shea, JA, Gossec, L, Leung, YY, Tillett, W, Elmamoun, M, Duffin, KC, Campbell, W, Christensen, R, Coates, L, Dures, E, Eder, L, FitzGerald, O, Gladman, D, Goel, N, Grieb, S, Hewlett, S, Hoejgaard, P, Kalyoncu, U, Lindsay, C, McHugh, N, Shea, B, Steinkoenig, I, Strand, V & Ogdie, A 2016, 'International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials', Annals of the Rheumatic Diseases. https://doi.org/10.1136/annrheumdis-2016-210242
Orbai, Ana-Maria ; de Wit, Maarten ; Mease, Philip ; Shea, Judy A. ; Gossec, Laure ; Leung, Ying Ying ; Tillett, William ; Elmamoun, Musaab ; Duffin, Kristina Callis ; Campbell, Willemina ; Christensen, Robin ; Coates, Laura ; Dures, Emma ; Eder, Lihi ; FitzGerald, Oliver ; Gladman, Dafna ; Goel, Niti ; Grieb, Suzanne ; Hewlett, Sarah ; Hoejgaard, Pil ; Kalyoncu, Umut ; Lindsay, Chris ; McHugh, Neil ; Shea, Bev ; Steinkoenig, Ingrid ; Strand, Vibeke ; Ogdie, Alexis. / International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials. In: Annals of the Rheumatic Diseases. 2016.
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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.",
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AU - Orbai, Ana-Maria

AU - de Wit, Maarten

AU - Mease, Philip

AU - Shea, Judy A.

AU - Gossec, Laure

AU - Leung, Ying Ying

AU - Tillett, William

AU - Elmamoun, Musaab

AU - Duffin, Kristina Callis

AU - Campbell, Willemina

AU - Christensen, Robin

AU - Coates, Laura

AU - Dures, Emma

AU - Eder, Lihi

AU - FitzGerald, Oliver

AU - Gladman, Dafna

AU - Goel, Niti

AU - Grieb, Suzanne

AU - Hewlett, Sarah

AU - Hoejgaard, Pil

AU - Kalyoncu, Umut

AU - Lindsay, Chris

AU - McHugh, Neil

AU - Shea, Bev

AU - Steinkoenig, Ingrid

AU - Strand, Vibeke

AU - Ogdie, Alexis

PY - 2016/9/9

Y1 - 2016/9/9

N2 - 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.

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