Rheumatology’s Divergent Thinkers

Dr. Tugwell recalls the tensions in that first meeting while trying to reach consensus on the top seven outcomes measures. “We had invited the top people,” he says, “and asked them to ‘take off the hat’ of having developed an outcome measure—which most of them had—and, in the interest of science, be prepared to consider which outcome might be agreed to as the one everyone should use.” Preliminary voting, done on electronic keypads, reflected an almost 50-50 split over which variables should be included, recalls Dr. Tugwell. “By the end of the conference, that bimodal voting had disappeared,” he says, “and we got a unimodal agreement on the top seven outcomes—pain, tender joints, swollen joints, function, patient’s global assessment, physician’s global assessment, and acute phase reactant.”

How It Works

The initial premise for OMERACT 1 was based on this summary statement: “Clinical trials are only as credible as their endpoints.” As many articles on OMERACT have emphasized, improving endpoint outcomes measurement requires a “data-driven, iterative alignment process.”² The procedure for developing conference agendas has evolved over the years, and topics are generated by the grassroots membership, not its leadership. OMERACT exists as a structure, supplying parameters and expertise for members to achieve a certain level of presentation.

During the earlier years, topics could be generated using the Delphi process, guided by committees until mature enough for general discussion. Now, with so many topics vying for attention, the process is a staged one: initiatives now begin as special interest groups (SIGs), when small groups of experts conduct a literature review and validation studies. The next step is a workshop, where studies are presented that help formulate and select which of the Four D domains (discomfort, disability, dollar cost, death) will constitute the focus. Finally the topic is formally presented at an OMERACT conference as a module, when evidence from the literature and from targeted studies is presented. Final selection of relevant measures is voted upon by conference attendees, and must pass the OMERACT Filter of Truth, Discrimination, and Feasibility.2 (See www.omeract.org for more information on the filter.) The process from special interest group to module can take several years, and is not for everyone, says Dr. Boers, “but if you don’t have tools to measure what’s working and what’s not working, there will be no progress, whatever drugs you develop. So we see ourselves as the slightly zany toolkit for rheumatology!”

Notable Accomplishments

OMERACT didn’t stop with reaching consensus on core sets of measures for RA. Other achievements include core sets of measures for osteoarthritis and osteoporosis, psoriasis/psoriatic arthritis, psychosocial measures, and a core set of data for cost-effectiveness evaluations. Workshops have been held for a wide range of conditions, including MRI in ankylosing spondylitis, fatigue, fibromyalgia, gout, low back pain, drug safety, and chemical biomarkers, among many others. When asked to highlight specific OMERACT accomplishments, all those interviewed praised the successful initiative of member John Kirwan, MD, professor of rheumatic diseases at the University of Bristol Rheumatology Unit (U.K.), to include patient representatives in the OMERACT process. (See “Patients as Research Partners,” above right.) “We now have 29 different groups working under the OMERACT umbrella,” Dr. Simon pointed out. “The product itself—all the supplements that have been published over the years—has been incredibly noteworthy.”