Progress on Incorporating the Patient Perspective in Outcome Assessment in Rheumatology and the Emergence of Life Impact Measures at OMERACT 9

Abstract

The Patient Perspective Workshop included over 100 researchers and 18 patient participants from 8 countries. Following preconference reading and short plenary presentations, breakout groups considered work undertaken on measurement of sleep, assessing interventions to develop the effective consumer, and assessing psychological and educational interventions. The workshop explored the best way to identify other outcome domains (and instruments) that should be measured in observational or interventional studies with broader intentions than simply altering outcomes captured in the traditional "core set" plus fatigue. Four sleep questionnaires showed promise and will be the subject of further study. The Effective Consumer scale (EC-17) was reviewed and the concept Effective Consumer was well received. Participants thought it worthwhile to measure the skills and attributes of an effective consumer and develop an intervention that would include education in all of the scale's categories. Assessment of educational and psychological interventions requires a wider set of instruments than is currently used; these should relate to the purpose of the intervention. This principle was extended to include wider measures of the impact of disease on life, as indicated in the International Classification of Functioning, Disability and Health. Life impact measure sets covering domains appropriate to different rheumatic conditions and focused on different interventions might be defined by future OMERACT consensus. Measurement instruments within these domains that are valid for use in rheumatic conditions can then be identified and, in the case of psychological and educational interventions, chosen to fit with the purpose of the intervention.

Clinical outcomes in psoriatic arthritis: A systematic literature review

“…Even with the large number of PROs available, some patient-reported domains, such as body image, are not being reported in recent publications. There are few studies in PsA aiming to know which domains are considered the most important in patients' opinions (12,106). Fatigue is a patient-reported domain described in only 15.5% of PsA articles.…”

How Much Is Fatigue Explained by Standard Clinical Characteristics of Disease Activity in Patients With Inflammatory Arthritis? A Longitudinal Study

“…While early studies on RA fatigue exist (6 -10), it is only over the last decade that fatigue in IA has become a variable of interest among rheumatology researchers and clinicians (11,12). This development occurred when the established international consensus conference Outcome Measures in Rheumatology (OMERACT) invited patients to become research partners (11,13,14). Following this OMERACT initiative, fatigue secured its place on the rheumatology research agenda internationally (11,13).…”

Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations

“…Moreover, the field of RA outcomes research has moved forward. New insights into the relationship between disease activity, joint damage, and disability have been put forward (8 -10), new indices or criteria have been proposed following patients in practice and/or trials (11)(12)(13), and an expansion of patientreported outcomes (PRO) has been suggested (14,15). Finally, new and highly effective recently approved drugs, such as inhibitors of tumor necrosis factor ␣ (TNF␣) and other biological agents in combination with methotrexate, have challenged outcomes assessment by their relatively rapid onset of action, their profound efficacy, and other aspects related to their clinical effectiveness (16).…”