Validation of the EULAR patient-derived rheumatoid arthritis impact of disease (RAID) preliminary score based on patients' perception of the impact of the disease on dimensions of health.

If it is considered that the aim of treatment in RA is BOTH to prevent later
disability AND to treat patients* symptoms, it seems important to use 2
different tools, one related to prediction of disability (i.e. synovitis
assessment), and a different score to assess patient perceived symptoms.
Some patient questionnaires are available, such as the Health Assessment
Questionnaire, HAQ, but they only take into account part of the domains which
are important for the patient (e.g. functional assessment for the HAQ). One
scale has been developed to incorporate three different dimensions, physical,
pain and patient global (the patient activity scale, but patients were not
directly involved in the development of this scale.
Thus, to date, to our knowledge, a validated composite index reflecting
patient-perceived impact of RA and taking into account all the domains of
importance for the patient does not exist.

The objectives of this study are to finalize and validate the preliminary RAID.

Cross-sectional assessment; international study at 1 time point. The aim is to
obtain data from 600 patients, i.e. 50 per country, by establishing a
collaborative study in 1 to 3 sites of the participating countries of
consecutive patients with RA. For each patient, data will be collected once.
Substudy "reliability"
Longitudinal assessment international study at 2 time points within a 2-7 days
interval.
The aim is to obtain data from 60 patients, i.e. 5 per country, a sub-group of
the face validity study (above).
Substudy "sensitivity to change"
Longitudinal assessment international study at 2 time points. For each patient,
data will be collected twice (10 to 14 weeks interval between assessments). The
aim is to obtain data from at least 120 patients, i.e. at least 10 per country;
a sub-group of the face validity study (above) or another subset of patients.

Burden
During this assessment the patient will fill in the questionnaire and current
results of laboratory tests (ESR and CRP) will be collected. Results must be
recent (less than 1 week), otherwise an extra blood test.
Patients in the substudy "reliability" (n=5) will return a second time, after 1
week, to fill in the questionnaire and a blood test.
Patients in the substudy "sensitivity to change" (n=10) will return a second
time, after 10-14 weeks, to fill in the questionnaire and a blood test.
Risk
No risk