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Table 1 OMERACT – best practice in disease-focused pharmaceutical trials

From: Evaluating complex health interventions: a critical analysis of the 'outcomes' concept

The first OMERACT conference on Outcome Measures in Rheumatoid Arthritis Clinical Trials [1] achieved agreement on a core set of outcomes measures to be used as a minimum in every clinical trial of rheumatoid arthritis (RA). These consist of acute phase reactants, disability, pain, patient global assessment, physician global assessment, swollen joint count, tender joint count, and radiographic studies of joints in any trial of 1 year or longer. Recently OMERACT has begun exploring the patient's perspectives of outcomes in RA [2, 3]. Patients identified as important not just physical outcomes such as pain and disability, but also sleep disturbance, fatigue, "a general feeling of wellness" and "a return to normality".
Hughes et al [4] have investigated the extent to which this 'best practice' in outcome measurement for RA trials reflects the outcomes experienced after a complex intervention. Their work on the outcomes aimed for and experienced by a range of acupuncture practitioners treating people with RA indicates that even with the addition of the subjective patient-centred measures, the OMERACT set of outcome measures would miss many of the treatment effects that were identified, effects that were diverse, unpredictable and long-term.
1. Tugwell P, Boers M: OMERACT conference on outcome measures in rheumatoid arthritis clinical trials: introduction. J Rheumatol 1993, 20: 528–530.
2. Kirwan J, Heiberg T, Hewlett S, Hughes R, Kvien T, Ahlmen M et al.: Outcomes from the Patient Perspective Workshop at OMERACT 6. J Rheumatol 2003, 30: 868–872.
3. Carr A, Hewlett S, Hughes R, Mitchell H, Ryan S, Carr M et al.: Rheumatology outcomes: the patient's perspective. J Rheumatol 2003, 30: 880–883.
4. Hughes JG, Goldbart J, Fairhurst E, Knowles K: Exploring acupuncturists' perceptions of treating patients with rheumatoid arthritis. Complement Ther Med 2007, 15: 101–108.