Patient selection: chronic GVHD
Assessment interval: every 3 months
Parameters:
(1) lichenoid/erythematous lesions in skin
(2) scleroderma-like changes in skin
(3) fascial changes
(4) mouth symptoms
(5) oral examination
(6) total serum bilirubin (as indicator of hepatic injury)
(7) worsening in any other domain
Data generated:
(1) previous total score for the first 6 items
(2) current total score for the first 6 items
(3) delta score for each of the first 6 items
delta score for a domain =
= (previous score) - (current score)
Remission (not defined in paper):
(1) previous total score > 0
(2) current total score = 0
(3) no delta score negative (none show worsening)
Major response:
(1) at least one delta score (of the first 6 items) >= 2
(2) no delta score negative (none show worsening)
Minor response:
(1) at least one delta score (of the first 6 items) = 1
(2) no delta score negative (none show worsening)
Progression:
(1) at least one delta score negative (worsening)
Unchanged (not defined in paper):
(1) no change between the 2 assessments
