Reliability and Validity of the Modified 7-Day Lee Chronic Graft-versus-Host Disease Symptom Scale.

Chronic graft-versus-host disease (cGVHD) adversely affects patient quality of life, functional status, and survival after allogenic hematopoietic cell transplantation. The Lee Symptom Scale is a 30-item scale developed to measure the symptoms of cGVHD. Although the original 30-item scale uses a 1-month recall period, we tested the reliability and validity of a 28-item scale (deleting 2 items based on supportive care needs rather than symptoms) with a 7-day recall period, a format that is more appropriate for use in clinical trials. Results show the modified 7-day scale is reliable and valid in the modern era and may be used to assess the symptom burden of cGVHD in clinical trials. Using the distribution method, a 5- to 6-point difference (half a standard deviation) is considered clinically meaningful.