There is general agreement regarding the most appropriate examinations and
methods to use to evaluate change in status in randomized controlled trials
(RCT). However, no guidelines exist to aid in determining and evaluating a
ctual status rather than change in status, particularly when applied to ind
ividual patients with rheumatoid arthritis (RA). In addition, methods appro
priate for clinical trials may not be useful in evaluating individual patie
nts because of time constraints. This report reviews current methods of eva
luation and develops modified methods, based on data bank research that wil
l be useful in clinical practice and in the evaluation of RCT and observati
onal studies. Using data from longitudinal observational data banks, furthe
r reduction in the number of joints examined is evaluated to reconcile the
time constraints of clinical practice with the need to maintain reliability
and validity. Percentile methods to determine severity status are applied
to the variables used in RCT and extended further to observational studies
and routine clinical practice. Shortened joint counts, based on modificatio
ns of the Ritchie method, are identified that allow for examination of grou
ps of 18 (clinical-18) and 16 (clinical-16) joints, the clinical-16 omittin
g the metatarsophalangeal joints. Using percentile charts, actual severity
valuations are given to the variables evaluated in the clinic as well as in
RCT. Disease activity status of clinic patients can be determined quantita
tively thus allowing clinicians further insight into the status and prognos
is of their patients. By quantifying disease activity severity, clinicians
and 3rd party payers can better evaluate the appropriateness of and respons
e to disease modifying antirheumatic drugs and biologic therapies. Further,
RCT can be evaluated as to severity status of patients participating, and
the generalizability of RCT can be better evaluated.