Psoriatic Arthritis Impact of Disease (PsAID12) Was Provisionally Endorsed at Omeract 2018 As Core Instrument to Measure Psoriatic Arthritis-Specific Health-Related Quality of Life in Randomized Controlled Trials and Longitudinal Observational Studies

Richard Holland¹, Robin Christensen², Niti Goel³, Pil Hoejgaard⁴, William Tillett⁵, Laure Gossec⁶, Maarten de Wit⁷, Neil McHugh⁸, Philip J. Mease⁹, Beverly Shea¹⁰, Ying Ying Leung¹¹, Dafna D Gladman¹², Christine Lindsay¹³, Laura C. Coates¹⁴, Alexis Ogdie¹⁵, Vibeke Strand¹⁶, Lara Fallon¹⁷, Julie Birt¹⁸, Kristina Callis Duffin¹⁹, Oliver FitzGerald²⁰, Peter Tugwell²¹, Dorcas Beaton^22,23 and Ana-Maria Orbai²⁴, ¹Royal Prince Alfred Hospital Medical Centre, Sydney, Australia, ²Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg, Denmark, ³Kezar Life Sciences; Duke University School of Medicine, Durham, NC, ⁴Center for Rheumatology and Spine Diseases - Gentofte, Rigshospitalet, Hellerup, Denmark, ⁵Royal National Hospital for Rheumatic Diseases and University of Bath, Bath, United Kingdom, ⁶Sorbonne Universités, Paris, France, ⁷EULAR standing committee of PARE, Zurich, Switzerland, ⁸Rheumatology, Royal National Hospital, Bath, Great Britain, ⁹Swedish Medical Center and University of Washington, Seattle, WA, ¹⁰School of Epidemiology, Public Health, and Preventive Medicine, Faculty of Medicine, University of Ottawa, and Ottawa Hospital Research Institute, Clinical Epidemiology Program, Ottawa, ON, Canada, ¹¹Singapore General Hospital, Singapore, Singapore, ¹²University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, ¹³Medical Affairs, Amgen Inc, Thousand Oaks, CA, ¹⁴University of Oxford, Oxford, United Kingdom, ¹⁵Medicine/Rheumatology and Epidemiology, University of Pennsylvania, Philadelphia, PA, ¹⁶Stanford University School of Medicine, Palo Alto, CA, ¹⁷Pfizer Canada, Montreal, QC, Canada, ¹⁸Eli Lilly and Company, Indianapolis, IN, ¹⁹Department of Dermatology, University of Utah, Salt Lake City, UT, ²⁰Department of Rheumatology, St. Vincent’s University Hospital, UCD School of Medicine and Medical Sciences and Conway Institute of Biomolecular and Biomedical Research, University College Dublin, Dublin, Ireland, ²¹Center For Global Health, Institute of Population Hlth, Ottawa, ON, Canada, ²²University of Toronto, Musculoskeletal Health and Outcomes Research, St. Michael's Hospital and Institute for Work and Health, Toronto, ON, Canada, ²³University of Toronto, Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, and the Institute for Health Policy Management and Evaluation, Toronto, ON, Canada, ²⁴Johns Hopkins University School of Medicine, Baltimore, MD

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: clinical trials, psoriatic arthritis and quality of life

Session Information

Date: Sunday, October 21, 2018

Title: 3S111 ACR Abstract: Spondyloarthritis Incl PsA–Clinical II: PsA Epidemiology (964–969)

Session Type: ACR Concurrent Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: The GRAPPA-OMERACT PsA working group (WG) is using the OMERACT Filter 2.1 instrument selection algorithm¹ to develop a Psoriatic Arthritis (PsA) core instrument set for randomized controlled trials (RCT) and longitudinal observational studies (LOS). The PsA Impact of Disease Instrument (PsAID12)² is a candidate instrument for PsA-specific Health Related Quality of Life (HRQoL)³. Based on evidence and consensus, the WG formulated a recommendation for PsAID12 and aimed to obtain endorsement by OMERACT.

Methods: We used a multi-step process (Fig1). PSAID12 psychometric evidence to fulfill Filter 2.1 was gathered in a systematic literature review (SLR) of patient reported outcomes (PROM) in PsA³, and additional analyses conducted in an LOS. Analyses that not been published were independently reviewed by the OMERACT technical advisory group. Data were presented to stakeholders [WG, patient research partners (PRP), workshop at the GRAPPA 2017 annual meeting⁴] followed by a survey to vote on domain match and feasibility. All data were summarized as PsAID12 OMERACT pre-conference reading material. Data and process were presented, discussed in 8 breakout groups, and voted on, at the OMERACT2018 conference (Terrigal, Australia, May 2018).

Results: An excerpt of the PsAID12 evidence presented at OMERACT 2018 is represented in Fig2. PsAID12 fulfilled with green (good to go) domain match, feasibility, reliability, and construct/longitudinal construct validity. Discrimination was assessed in an LOS within change groups. Minimal clinically important improvement in 2 LOS^2,5 were 3 and 1.4. PsAID12 fulfilled with amber (provisional endorsement) discrimination and thresholds of meaning. The overall WG recommendation was formulated: amber/provisional endorsement of PsAID12 for measuring PsA specific-HRQoL in RCTs and LOS. Of 113 participants at the PsA OMERACT workshop 87% (97) voted “yes” endorsing this recommendation. 17 were PRPs and 93% voted “yes”. The WG set a research agenda to fully endorse PsAID12.

Conclusion: At OMERACT 2018, PsAID12 was the first PROM provisionally endorsed as core instrument to measure PsA-specific HRQoL in RCTs. PsAID12 discrimination and improvement thresholds will be studied in RCTs.

Refs: 1OMERACT handbook, 2Gossec 2014, 3Højgaard 2017, 4Holland 2018, 5 Holland 2017

Disclosure: R. Holland, None; R. Christensen, None; N. Goel, None; P. Hoejgaard, None; W. Tillett, None; L. Gossec, None; M. de Wit, None; N. McHugh, None; P. J. Mease, None; B. Shea, None; Y. Y. Leung, None; D. D. Gladman, None; C. Lindsay, None; L. C. Coates, None; A. Ogdie, None; V. Strand, None; L. Fallon, Pfizer Inc, 1,Pfizer Inc, 3; J. Birt, Eli Lilly and Company, 1,Eli Lilly and Company, 3; K. Callis Duffin, None; O. FitzGerald, None; P. Tugwell, None; D. Beaton, None; A. M. Orbai, None.

To cite this abstract in AMA style:

Holland R, Christensen R, Goel N, Hoejgaard P, Tillett W, Gossec L, de Wit M, McHugh N, Mease PJ, Shea B, Leung YY, Gladman DD, Lindsay C, Coates LC, Ogdie A, Strand V, Fallon L, Birt J, Callis Duffin K, FitzGerald O, Tugwell P, Beaton D, Orbai AM. Psoriatic Arthritis Impact of Disease (PsAID12) Was Provisionally Endorsed at Omeract 2018 As Core Instrument to Measure Psoriatic Arthritis-Specific Health-Related Quality of Life in Randomized Controlled Trials and Longitudinal Observational Studies [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/psoriatic-arthritis-impact-of-disease-psaid12-was-provisionally-endorsed-at-omeract-2018-as-core-instrument-to-measure-psoriatic-arthritis-specific-health-related-quality-of-life-in-randomized-contr/. Accessed .

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