Instrument-based scores are often used as outcome measures. However, little
is known about what changes in scores mean in terms of a clinical assessme
nt of improvement or deterioration. The purpose of this report was to deter
mine how much change in standard instrument scores represents a clinically
detectable improvement or deterioration. The Veterans Affairs (VA) Cooperat
ive Study of Clozapine in Refractory Schizophrenia evaluated 423 patients o
n clozapine or haloperidol. Symptoms and quality of life scales were comple
ted at baseline; 6 weeks; and 3, 6, and 12 months. Among patients judged as
"improved" by clinicians, the average percentage changes were a 21 percent
decrease in Positive and Negative Syndrome Scale (PANSS) scores and a 26 p
ercent increase in Quality of Life Scale (QLS) scores across all followup p
eriods. The change in mean seven-point item scores were -0.46 (PANSS) and 0
.23 (QLS). A major gain in clinically assessed improvement to "much better"
was associated with a 45 percent decline in PANSS scores and 50 percent in
crease in QLS scores (change in mean seven-point item scores -0.88 and 0.92
, respectively). Thus, modest changes in psychometric scales assessing symp
toms and quality of life reflect clinically detectable improvement.