Putting it All Together: Tools for Documenting Chronic GVHD Response AssessmentSandra A. Mitchell, CRNP, M.Sc.N., AOCN

National Institutes of Health

Bethesda, MD

Components of Chronic GVHD Response Evaluation

• Chronic GVHD-specific core measures

– Clinician assessed

– Self-report

• Chronic GVHD-non-specific ancillary measures

– Clinician assessed

– Self-report

Chronic GVHD-Specific Core Measures—Clinician Assessed

– Skin– Eyes– Mouth– Gastrointestinal symptoms– Laboratory Studies– Pulmonary Function Tests– Health care provider global ratings of chronic

GVHD severity (mild, moderate, severe), symptom severity (0–10 scale), and 7-point interval change score

Chronic GVHD-Specific Core Measures—Patient Self-Report

• Lee Chronic GVHD Symptom Scale

Chronic GVHD Non-Specific Ancillary Measures—Clinician Assessed

– Weight

– Functional Performance (2 minute walk and grip strength)

– Karnofsky/Lansky Performance Status

– Range of motion (attach physical therapy report

Chronic GVHD Non-Specific Ancillary Measures—Patient Self-Report

– Self-report measures (adults):– Human Activity Profile– SF-36– FACT-BMT

– Self-report measures (children):– Activities Scale for Kids (ASK)– Child Health Ratings Inventories -Hematopoietic

Stem Cell Transplant Module (CHRIs-HSCT).

Chronic GVHD Activity Assessment—Clinician

Click here to open Appendix E: Response Criteria Evaluation form—Clinician

Chronic GVHD Activity Assessment—Clinician

Click here to open Appendix E: Response Criteria Evaluation form—Clinician

Chronic GVHD-Specific Core Measures—Patient Reported

• Peak symptom severity in the last seven days, 0-10 scale:– Itching– Mouth dryness (subjective decrease in oral wetness) – Mouth pain (in the absence of stimulation such as

swallowing or oral hygiene) – Mouth sensitivity (irritation resulting from normally

tolerated spices, foods, liquids or flavors)– Main eye complaint

• Presence/absence of vulvovaginal symptoms (if present, refer for specialist examination)

Chronic GVHD-Specific Core Measures—Patient Reported

• Patient’s overall evaluation of:

– Chronic GVHD severity (mild, moderate, severe)

– Overall chronic GVHD symptom severity (0–10 scale)

– Whether, compared to one month ago, their chronic GVHD symptoms are very much worse to very much better on a 7-point scale

Chronic GVHD Activity Assessment—Patient Self-Report

Click here to open Appendix E: Response Criteria Evaluation Form—Patient

Proposed Measures (Forms A&B)Measure Clinician assessed Patient reportedCore – Chronic GVHD Specific Signs Organ specific measures N/ASymptoms Clinician assessed Patient reported

Lee Symptom Scale

Global Rating 7 point change scale 7 point change scaleMild-moderate-severe Mild-moderate-severe0-10 severity scale 0-10 severity scale

Ancillary - CGVHD Non-SpecificFunction Grip Strength HAP

2 min walk time ASK (children)

Performance status Karnofsky/Lansky N/A

Quality of life N/A FACT-BMTSF-36 v.2CHRIs-HSCT (children)

Interval for Evaluation

• Intervals for re-evaluation are study protocol specific

• Suggest that measures are made at 3 month intervals and whenever a major change is made in treatment

For More Information

• More detailed information about the response criteria is available in the publication: “Measuring Therapeutic Response in Chronic Graft-Versus-Host Disease, NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-Versus-Host Disease: IV. Response Criteria Working Group Report” In: Biology of Blood and Marrow Transplantation, 2006 (in press). – Available at http://www.bbmt.org

• Supplementary information and updates are available at http://www.asbmt.org/policystat/policy.htm