Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017 Oct;44(10):1522-1528.
doi: 10.3899/jrheum.160904. Epub 2017 Feb 1.

Updating the Psoriatic Arthritis (PsA) Core Domain Set: A Report from the PsA Workshop at OMERACT 2016

Affiliations

Updating the Psoriatic Arthritis (PsA) Core Domain Set: A Report from the PsA Workshop at OMERACT 2016

Ana-Maria Orbai et al. J Rheumatol. 2017 Oct.

Erratum in

Abstract

Objective: To include the patient perspective in accordance with the Outcome Measures in Rheumatology (OMERACT) Filter 2.0 in the updated Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials (RCT) and longitudinal observational studies (LOS).

Methods: At OMERACT 2016, research conducted to update the PsA Core Domain Set was presented and discussed in breakout groups. The updated PsA Core Domain Set was voted on and endorsed by OMERACT participants.

Results: We conducted a systematic literature review of domains measured in PsA RCT and LOS, and identified 24 domains. We conducted 24 focus groups with 130 patients from 7 countries representing 5 continents to identify patient domains. We achieved consensus through 2 rounds of separate surveys with 50 patients and 75 physicians, and a nominal group technique meeting with 12 patients and 12 physicians. We conducted a workshop and breakout groups at OMERACT 2016 in which findings were presented and discussed. The updated PsA Core Domain Set endorsed with 90% agreement by OMERACT 2016 participants included musculoskeletal disease activity, skin disease activity, fatigue, pain, patient's global assessment, physical function, health-related quality of life, and systemic inflammation, which were recommended for all RCT and LOS. These were important, but not required in all RCT and LOS: economic cost, emotional well-being, participation, and structural damage. Independence, sleep, stiffness, and treatment burden were on the research agenda.

Conclusion: The updated PsA Core Domain Set was endorsed at OMERACT 2016. Next steps for the PsA working group include evaluation of PsA outcome measures and development of a PsA Core Outcome Measurement Set.

Keywords: CORE SET; OUTCOME MEASURES; PSORIATIC ARTHRITIS.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Domains are shown on the X axis with proportion of studies measuring each domain on the Y axis. The black 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
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 diseaserelated 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 Dec 13(E-pub ahead of print).
Figure 3
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.

References

    1. Tunis SR, Clarke M, Gorst SL, Gargon E, Blazeby JM, Altman DG, et al. Improving the relevance and consistency of outcomes in comparative effectiveness research. J Comp Eff Res. 2016;5:193–205. - PMC - PubMed
    1. Boers M, Brooks P, Strand CV, Tugwell P. The OMERACT filter for Outcome Measures in Rheumatology. J Rheumatol. 1998;25:198–199. - PubMed
    1. Boers M, Kirwan J, Tugwell P, Beaton D, Bingham CO, 3rd, Conaghan PG, et al. The OMERACT Handbook. OMERACT. 2014
    1. Gladman DD, Mease PJ, Strand V, Healy P, Helliwell PS, Fitzgerald O, et al. Consensus on a core set of domains for psoriatic arthritis. J Rheumatol. 2007;34:1167–1170. - PubMed
    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;67:745–753. - PubMed

Substances