Future psoriatic arthritis (PsA) randomized controlled trials and observational studies should measure and report on outcomes that are important to both patients and clinicians, according to research published in Annals of the Rheumatic Diseases. Shared decision-making and patient-centered medicine should be the goal of future outcomes set forth in clinical trials.
Ana-Maria Orbai, MD, MHS, of the Johns Hopkins Arthritis Center in Baltimore, MD, and colleagues, set out to identify a core set of outcomes representative of both patient and physician priorities that researchers should aim to measure in PsA clinical trials.
The research team conducted a systematic literature review of domains assessed in PsA. International focus groups were subsequently used to identify the domains identified as most important to patients with PsA. Two international web-based surveys were then conducted, encompassing patients and physicians, to prioritize the domains.
An international face-to-face meeting was then held with both patients and physicians to come to an agreement on the most important domains. Finally, Dr Orbai and colleagues presented these consensus domains at the Outcome Measures in Rheumatology (OMERACT) conference in May 2016.
High Yield Data Summary
- A core domain set presented at OMERACT 2016 including musculoskeletal disease activity, skin disease activity, pain, patient global, physical function, health-related quality of life, fatigue, and systemic inflammation was endorsed by 90% of participants
In the process of achieving consensus, 2 qualitative research studies were independently conducted to identify important outcomes for patients with PsA. All participants met the Classification Criteria for Psoriatic Arthritis.
Dr Orbai and colleagues identified 24 domains through the systematic literature review and 34 domains through the international focus groups. Fifty patients and 75 physicians participated in rating the domains in order of importance, and during the March 2016 face-to-face meeting, 12 patients and 12 physicians agreed on 10 candidate domains.
Forty-nine patients and 71 physicians rated the domains’ importance. Five domains were deemed “important” to >70% of both groups (musculoskeletal disease activity, cutaneous disease activity, structural damage, pain, and physical function.
Two domains were important to >70% of patients (fatigue and participation), and 2 domains were important to >70% of physicians (patient global and systemic inflammation). At OMERACT 2016, the updated PsA core domain set—endorsed by 90% of participants—included the following:
- Musculoskeletal disease activity
- Skin disease activity
- Patient global domain
- Physical function
- Health-related quality of life
- Systemic Inflammation
Summary and Clinical Applicability
By integrating patients at every research phase and sampling patients with PsA from 5 continents, researchers were able to increase the generalizability of the study findings, which confirm the previously demonstrated impact of PsA on quality of life.
“This study confirms that patients’ and physicians’ priorities are different,” concluded Dr Orbai. “A core domain set with face validity should capture the diversity of stakeholder perspectives. We demonstrated that inclusion of patient and physician perspectives is possible using a data-driven process and ensuring awareness of both perspectives through the development of a core outcome set.”
Dr Orbai notes that next steps are “examining outcome measures’ psychometric properties for measuring each core set domain and selecting a core set of outcome measures that are adequate and not redundant.”
Limitations and Disclosures
- Surveys were conducted in English and French only, resulting in a limited selection of patients
- The consensus meeting was also conducted in English, limiting it to English-speaking patients and physicians
Drs Orbai and de Wit report receiving grants from Celgene and Janssen (to Johns Hopkins University). Dr Orabi also received consulting fees from Janssen, and Dr de Wit also received fees from Novartis and BMS. Dr Mease reports grants from AbbVie, Amgen, Brisol-Myers Squibb, Celegene, Janssen, Lilly, Novartis, Pfizer, Sun, and UCB, as well as grants and additional funding from Crescendo, Corrona, Demira, Genentech, Merck, and Zynerba. Dr Tillett reports receiving grants, consulting, and speakerfees from AbbVie, Pfizer, UCB, Novarits, and Celgene. Dr FitzGerald reports receiving grants and/or consulting fees from AbbVie, Pfizer, BMS, Celgene, Janssen, Novartis, UCB, and Lilly. Dr Hoejgaard reports receiving personal fees from Celgene. Dr Goel is a full time employee of Quintiles, Inc., Dr McHugh reports receiving grants from the UK Government to Host Institution, and Drs de Witt and Strand are members of the executive of OMERACT, who receives arms-length funding from 36 companies.
Orbai A-M, de Wit M, Mease P, et al. International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials. Ann Rheum Dis. 2016 Sep 9. doi: 10.1136/annrheumdis-2016-210242 [Epub ahead of print]