Progress since OMERACT 6 on including patient perspective in rheumatoid arthritis outcome assessment.

The first OMERACT Patient Perspective Workshop took place at OMERACT 6 in 2002. Through a series of meetings and discussion sessions a research agenda emerged and this report outlines progress made on this agenda. Work on identifying novel outcomes, instruments, and methods has shown similarities across European countries in the importance patients with rheumatoid arthritis (RA) attach to specific outcomes, in particular fatigue. Validation of an appropriate instrument to measure fatigue in patients with RA is currently being investigated. Frequent or repeated real-time assessment of symptoms such as pain and fatigue is becoming possible using electronic systems. An OMERACT Patient Panel has been established, and has produced a glossary for patients involved in supporting clinical research. In some centers, efforts are being made to provide Patient Research Partners with knowledge and skills that will enhance their contribution, and some of these approaches will be incorporated into OMERACT 7. The research agenda that was developed during the first Patient Perspective Workshop has stimulated new work in several areas. In addition, international attention has been drawn to the need to make sure that the patient's perspective is not lost among the technical expertise of rheumatology.

The influence of sex on rheumatoid arthritis: a prospective study of onset and outcome after 2 years.

OBJECTIVE: This prospective study analyzed influence of patient's sex on early rheumatoid arthritis (RA) within one year of disease onset and after 2 years' followup. METHODS: A total of 844 consecutive patients, 538 women, with RA of less than 12 months were studied. Standardized clinical and radiographic assessments were performed at study entry and after 2 years. The association of several variables at study entry with the outcome variables Disease Activity Score (DAS28), functional disability measured by the Health Assessment Questionnaire (HAQ), and, in 390 patients, Larsen score at the 2-year followup were analyzed in men and women separately. RESULTS: At study entry the women were younger compared with the men and the sexes showed different age distributions. The women had higher DAS28 and HAQ scores. However, women below 50 years of age at study entry had milder disease than older women and close to that of men. At 2-year followup the women still had higher DAS28 and HAQ scores compared to men, who had achieved remission in a higher frequency. Larsen score showed no sex difference either at study entry or after 2 years. Presence of rheumatoid factor (RF) was associated with lower age at study entry and higher DAS28 at followup in men only. Higher DAS28 and HAQ scores at entry were more strongly correlated with severe disease at followup in women than in men. Presence of the "shared epitope" was not associated with age or the outcome variables DAS28 and Larsen score in either sex. CONCLUSION: The disease phenotype in early RA was significantly different between men and women, particularly concerning age, disease activity, and functional capacity. There were differences between the sexes concerning early disease characteristics associated with outcome at 2 years of followup.

Six- and 24-month follow-up of pool exercise therapy and education for patients with fibromyalgia.

OBJECTIVE: To follow patients with fibromyalgia six and 24 months after they finished a six-month treatment programme. The programme comprised pool exercise therapy, adjusted to the patients' limitations, and education based on their health problems. METHODS: Twenty-six patients were examined six and 24 months after the completion of the treatment programme with the Fibromyalgia Impact Questionnaire (FIQ), SF-36, the 6-minute walk test, and the Grippit measure. The values obtained at the follow-up examinations were compared with the baseline and post-treatment values. RESULTS: As compared with baseline, symptom severity (FIQ, SF-36), physical function (FIQ, SF-36, 6-minute walk test) and quality of life (SF-36) still showed improvements six months after the completion of treatment (p <0.05). Pain (FIQ, SF-36), fatigue (FIQ, SF-36), walking ability, and social function (SF-36) still showed improvements 2 years after the completion of the programme as compared with the baseline values (p < 0.05). No significant changes were found for these variables, when the values obtained at the two follow-up examinations were compared with those of the post-treatment examination. CONCLUSIONS: Improvements in symptom severity, physical function and social function were still found six and 24 months after the completed treatment programme.

Outcomes from the Patient Perspective Workshop at OMERACT 6.

The objective of the Patient Perspective Workshop at OMERACT 6 was to address the question of assessing the outcomes of intervention in rheumatoid arthritis (RA) from the perspective of those who experience the disease themselves. This was done by reviewing the current state of research in the area, identifying the requirements for the development of valid instruments, delineating a research agenda that can attain these requirements, and motivating participants to undertake the appropriate research. Through a series of meetings and discussion sessions a research agenda emerged that includes: exploring subjective experiences of RA identified by patients as important but not encompassed within the current "core set" of outcome measures (such as a sense of well being, fatigue, and disturbed sleep); clarifying terminology; and empowering patients to be more effective partners in outcomes research. These were supported by the OMERACT plenary session. Specific actions were required by both patient participants and organizers to ensure the nature of the conference, its focus and method of working were understood, and that the patient participants were sufficiently confident to make their contribution.