Article Figures & Data
- Figure 1.
Domains are shown on the X axis with proportion of studies measuring each domain on the Y axis. The yellow mark designates 2006 PsA core domains. RCT: randomized controlled trials; LOS: longitudinal observational studies; HRQL: health-related quality of life; MD: physician; MRI: magnetic resonance imaging; US: ultrasound.
- Figure 2.
Updated 2016 PsA Core Domain Set. MSK disease activity includes peripheral joints, enthesitis, dactylitis, and spine symptoms. Skin activity includes skin and nails. PtGA is defined as patient-reported disease-related health status. The inner circle includes domains recommended for measurement in every RCT and LOS. The middle circle includes domains that are important, but not required in every RCT and LOS. The outer circle contains domains that may be important, but need further study. PsA: psoriatic arthritis; MSK: musculoskeletal; PtGA: patient’s global assessment; RCT: randomized controlled trial; LOS: longitudinal observational studies. Reproduced with permission from Orbai, et al. Ann Rheum Dis 2016 Sep 9 (E-pub ahead of print).
- Figure 3.
Updated PsA Core Domain Set and corresponding OMERACT core areas. Domains in bold face are in the core set (to be measured in all RCT), and domains in plain font are in the middle circle (highly recommended, but not mandatory). PsA: psoriatic arthritis; OMERACT: Outcome Measures in Rheumatology; RCT: randomized controlled trial; HRQOL: health-related quality of life; MSK: musculoskeletal. From Boers M, et al. J Clin Epidemiol 2014;67:745–53; adapted with permission.
- Table 1.
Domains in the 2006 PsA Core Domain Set and candidate domains for the updated core set.
OMERACT 2006 PsA Core Domain Set OMERACT 2014 Voted (≥ 70%) Inclusion in the Core Set Draft Core Domain Set at the End of the NGT Meeting 2016 Draft Core Set after the Second Patient and Physician Survey* Peripheral joint activity Dactylitis MSK disease activity MSK disease activity Skin activity Skin disease activity Skin disease activity Pain Pain Pain Patient global PtGA PtGA Physical function Physical function Physical function HRQOL Participation Participation Emotional well-being Fatigue Fatigue Fatigue Systemic inflammation Systemic inflammation Structural damage ** Structural damage ** ↵* During the second survey, patients and physicians rated the importance of domains proposed after the NGT meeting – emotional well-being was moved out of the core because less than 70% of either physician or patient respondents rated it as at least 8 on a scale from 0–10.
↵** Structural damage was recommended for assessment at least once during the development of a new drug for PsA. PsA: psoriatic arthritis; OMERACT: Outcome Measures in Rheumatology; NGT: nominal group technique; HRQOL: health-related quality of life; MSK: musculoskeletal; PtGA: patient’s global assessment.
Country International Patient Focus Group Participants Qualitative Data Analysis (Patient Researchers, PRP) Survey Participants Nominal Group Technique Patient Participants and PRP Australia 7 Brazil 12 1 1 Canada 1 1 2 France 12 4 Hong Kong 1 Ireland 9 1 Italy 1 Netherlands 17 2 1 1 Norway 1 1 Romania 1 Singapore 13 8 Spain 1 UK 41 2 3 1 USA 27 1 18 4 Total 129 6 50 12 PsA: psoriatic arthritis; PRP: patient research partners.
Domain Votes* Inner Core Position Middle Circle Position Yes No Insufficient or Evidence Information Yes No Insufficient Evidence or Information MSK disease activity 85 8 7 — — — Skin activity 91 6 4 — — — Systemic inflammation 81 14 4 — — — Participation 55 32 13 74 19 7 Emotional well-being 31 57 13 77 17 5 Structural damage — — — 79 15 5 ↵* The number of OMERACT participants who voted for each question ranged from 132 to 138. PsA: psoriatic arthritis; MSK: musculoskeletal.
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