Modified Lee Symptom Scale (7-day bother) 

Technology Overview

cGVHD adversely affects patient quality of life, functional status, and survival after allogenic hematopoietic cell transplantation (HCT). The original Lee Symptom Scale is a 30-item scale that was developed to measure the symptoms of cGVHD. The original 30-item scale uses a one-month recall period, which can be challenging to measure/record as symptoms can wax and wane, and patients may be treated in an outpatient setting. The Lee lab at Fred Hutchinson Cancer Center developed the Modified Lee Symptom Scale with a 7-day recall period, a format that is more appropriate for use in clinical trials. Scoring of the MODIFIED LSS follows the same principles as the original scale. In some cases, two items are not included: “need to use oxygen” and “receiving nutrition from an intravenous line or feeding tube.” These two items may be removed from the scoring algorithm. Change scores are interpretable if the same formula is used for scoring enrollment and follow-up surveys. Contact the developer for code to score the instrument.

Applications

•      May be used to assess the symptom burden of cGVHD in clinical practice and in trials for new therapies for cGVHD  
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Advantages

•      Simple (~5 minutes completion time) and patient self-administered questionnaire reflective of multi-organ manifestations of cGVHD
•      Recall is better over shorter periods (7-day vs 30-day in the original LSS) which is preferred for symptom assessment  
•      The reliability and validity of the original LSS with 30-day recall period is preserved in the 7-day LSS, making this format more appropriate for use in the clinical trial settings  
•      This scale is also mentioned in the FDA-labeling of ibrutinib for chronic GVHD

Patent Information

• Copyrighted

Market Overview

• cGVHD is the most common long-term complication of HCT and is associated with a decreased quality of life, impaired functional status, continued need for immunosuppressive medications, and increased non-relapse mortality. 20 – 50% of allogeneic transplant survivors develop cGVHD.

Investigator Overview

• Stephanie Lee MD, MPH. Professor and Associate Director Clinical Research Division; David and Patricia Giuliani/Oliver Press Endowed Chair in Cancer Research