Abstract and Introduction
Background: Appropriate evaluation of disease or treatment outcomes requires a good understanding of the aspects of the disease and its consequences that actually matter to patients. The OMERACT process has identified several domains of outcome measurement for chronic gout, but patient involvement has only been briefly described.
Objectives: To make the results of patient involvement more explicit, the current study reports on an exercise carried out in the early part of the OMERACT domain identification process.
Methods: Patients with gout were asked to identify areas of life affected by gout. These areas were rated (0–10) and ranked for importance by a second group of patients with gout recruited from both primary care and a rheumatology clinic.
Results: Thirty-one patients with gout performed the initial generation of areas of importance. These areas were combined to form 14 items, which were ranked and scored by 107 patients. Four areas were ranked first to third most important by at least 20% of participants. These were pain (median rating, 10), loss of joint motion (median rating, 9), work loss (median rating, 7), and joint inflammation/swelling (median rating, 8). Three additional areas were ranked highly by at least 10% of patients: difficulty with wearing shoes, having to undertake a restrictive diet, and sleep.
Conclusions: These data largely confirmed the relevance of the gout OMERACT domains while identifying additional issues for patients that require further investigation.
Appropriate evaluation of disease or treatment outcomes requires a good understanding of the aspects of the disease and its consequences that actually matter to patients. Gout is a common and disabling condition, yet there are few published studies that describe which outcomes are of importance to patients. Lindsay et al identified 3 key themes that described the concerns of patients with gout: (i) the directly experienced symptoms of the disease such as pain and disability, (ii) the progressive nature of the condition, and (iii) lack of knowledge about gout.
The OMERACT process has identified several domains of outcome measurement for chronic and acute gout, but patient involvement has only been briefly described. The process of domain identification and endorsement consisted of several steps. Expert rheumatologist and pharmaceutical industry representatives discussed domains as a special interest group at OMERACT 7 in 2004 and OMERACT 8 in 2006. During the second meeting, results of an unpublished patient survey were presented by Edwards in which 28 patients with gout from 1 rheumatology service were asked about how gout affected their lives. The top-ranked areas were pain, immobility during flares, unpredictability of attacks, dependency and limitations of daily activities, and abandonment of hobbies or leisure activities. A preliminary list of domains was developed from OMERACT 8 and was examined through an online Delphi survey among rheumatologists. At OMERACT 9 in 2008, domains for outcome measurement in acute and chronic gout were discussed in plenary and small group sessions by all OMERACT participants. The main results of the current study were discussed briefly. A formal voting procedure whereby 7 domains received endorsement as being mandatory for chronic gout studies from at least 70% of participants was the final step.
To make the results of patient involvement more explicit, the current study reports on an exercise carried out in the early part of the OMERACT domain identification process. In doing so, we also highlight areas in which further work needs to be done to properly understand the patients' perspective.