Patients Add Power to Research Initiatives

OMERACT (Outcome Measures in Rheumatology) has provided a great stimulus to think about the effects of rheumatic diseases on patients and society, and the impact of their treatment.¹ It all started in 1992, with the development of a core set of outcome measures for rheumatoid arthritis (RA). Officially, these measures are termed the World Health Organization and International League of Associations for Rheumatology core endpoints for symptom-modifying antirheumatic drugs in rheumatoid arthritis clinical trials, but they are the product of OMERACT.² This first OMERACT conference in which I participated brought together 92 rheumatologists, methodologists, drug regulatory officials, and pharmaceutical physicians from all over the world. We were pleased—and rightly so—that we had been able to achieve an international and multidisciplinary consensus statement that was subsequently endorsed by both ACR and the European League Against Rheumatism. However, it took us 10 years to discover that there was something missing—the patients’ perspective.

OMERACT 6, in 2002, was the first time patients participated. The 11 patients (see Figure 1) all had RA, came from seven countries, and contributed principally to discussions on “minimally clinically important changes” in relation to the core set. However, the patients also joined many of the other conference sessions and workshops. The conference report states that, “A number of subjective experiences of RA are not encompassed within the current core set of outcome measures, but were identified by patients as important consequences of their disease. These include a sense of well-being, fatigue, and disturbed sleep, but further work is required to develop and explore this list, and to develop valid measurement instruments.”³ Further work was indeed undertaken. The findings were published and the issues considered at subsequent OMERACT meetings. In the end, 16 years after its first agreement, OMERACT decided that the RA core set should include fatigue in future studies.⁴ It has not stopped there. The pressure is on to consider treatment outcomes in the wider context of life impact measures, clearly the perspective relevant to patients.⁵

Fig. 1: OMERACT 6 patient participants working with mentors in a group session.

A Necessary Perspective

These days, OMERACT without patients would be like a coach without horses or a bride without a groom. And the patients are not just nominal participants, there to look good and make up the numbers. Patients have guaranteed places at OMERACT meetings, take a full part in all the activities (including facilitating group sessions, reporting back to plenary sessions, and writing the published conference reports), have been included in many OMERACT working groups, and have their own working committee. They all liaise closely with the two executive members (Laure Gossec and myself) who are responsible for ensuring the patient perspective is included in OMERACT activities. Support for patient participants is provided through funding to attend OMERACT conferences, special introductory and update sessions at the conference, support to join in local working group activities, the provision of a patient glossary, and regular email updates.¹ At the last OMERACT conference there were 21 patient partners comprising 10% of the participants (see Figure 2).