Table 1 Research questions defined by the panel in November 2006 to be addressed by the literature search, and the respective search terms used
Research questionsSearch terms
What literature is available on time as an element of response or state?“arthritis rheumatoid”, outcome assessment (health care)”, “sustained response”, “sustained remission”, “timing”, “onset of action”, “time factors”
Which measures of disease activity are validated for defining remission/low disease activity state/patient’s acceptable symptom state (PASS)?“arthritis rheumatoid”, “outcome assessment (health care)”, “health status indicators”, “remission induction”, “patient satisfaction”, “outcome and process assessment (health care)”, “health status”, “remission”, “patient acceptable”
Which are the single variables and composite indices that have demonstrated (a) predictive validity for radiographic progression, (b) correlation with functional impairment, (c) correlation with patient global assessment of disease activity, or (d) physician/evaluator global assessment of disease activity?“arthritis, rheumatoid”, “outcome assessment (health care)”, “arthritis, rheumatoid/radiography”, “disease progression”, “disability evaluation”, “health status”, “health status indicators”
Which is the added value (in terms of predictive validity or discriminant capacity with respect to radiographic progression) of US/MRI for the evaluation of synovitis in comparison with the value of clinical joint count or other variables?“arthritis, rheumatoid”, “synovitis”, “magnetic resonance imaging”, “ultrasonography”
What is the value of including function in a composite index to assess disease activity?“arthritis, rheumatoid”, “disability evaluation”, “health status indicators”
What is the evidence that fatigue and other patient-reported health status measures reflect disease activity?“arthritis, rheumatoid”, “outcome assessment (health care)”, “disability evaluation”, “health status”, “patient satisfaction”, “fatigue”
What is the consequence of having different levels of disease activity as eligibility criteria in terms of responsiveness and power?*“patient selection”, “treatment outcome”
To what extent does baseline activity influence response and measures used?*“patient selection”, “treatment outcome”
What is the evidence that structural damage/duration of the disease has an impact on the validity of the disease activity measure (discriminant capacity of true anti-inflammatory drugs)?“arthritis, rheumatoid”, “disease duration”, “chronicity”, “severity”, “discrimination”, “power”, “response”
Which is the added value (predictive validity, discriminant validity) of status score vs response score? (change in % or absolute value or combination of state and change)†“clinical trials”, “treatment outcome”, “severity of illness index”, “statistics”
What literature supports the use of dichotomous response measures over the use of change in continuous measures as an outcome in trials?†“clinical trials”, “treatment outcome”, “severity of illness index”, “statistics”
  • US, ultrasonography.*, †Questions addressed jointly in the search.