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Method: The baseline and three month follow-up data from a daily clinical practice cohort of patients with rheumatoid arthritis starting on TNFα blocking agents was used. Patients were classified as responders or non-responders according to an objective, disease-specific clinical outcome measure. A visual analogue scale (range 0-100 mm) for general health (GH) was used as a patient self-reporting outcome measure. At three months after starting on anti-TNFα, baseline GH was also retrospectively rated by means of a then-test. Differences were calculated between baseline and three months values and between then-test and baseline values. Significant differences were identified between responders and non-responders using a student's t-test.
Results: At three months 45.1% of the patients were classified as responder and 54.9% as non-responder. Mean baseline GH values were 62 for responders and 59 for non-responders, these values did not differ between the two groups (p=0.494). Responders reported a 30 (95% CI: 22; 39) VAS GH improvement compared to an improvement of 10 (95% CI: 3; 17) for non-responders. The mean difference between the then-test and baseline value was equal (p=0.561) for both responders (mean: 10, 95% CI: 3; 16) and non-responders (mean: 7, 95% CI: 1; 13), values being in favour of baseline. Therefore, the alternative hypothesis that outcome dependency would be present, in the sense that the differences between the then-test and the baseline value would be different for responders and non-responders, was rejected.
Conclusion: Both responders and non-responders retrospectively rated their general health worse than they did at baseline. Scale-recalibration was not dependent on the outcome of the intervention. This finding questions the validity of a then-test for assessing adaptation or correction for scale-recalibration.