Developing international consensus on measures of improvement for patients with myositis.
We discuss methods of developing consensus in measuring improvement in myositis. We consider selecting candidate variables, reliability and validity, percentage improvement/worsening rules, rules based on CART and logistic regression. We discuss criteria for determining an acceptable rule that include both numerical measures and physician acceptance.
Lachenbruch
Peter A
PA
FDA Center for Biologics Evaluation and Research, USA. lachenbruchpa@aol.com
Miller
Frederick W
FW
Rider
Lisa G
LG
D002986:Clinical Trials as Topic; D032921:Consensus; D006801:Humans; D007391:International Cooperation; D016015:Logistic Models; D009220:Myositis / Q000628:therapy*; D016896:Treatment Outcome