1. Putting it All Together: Tools for Documenting Chronic GVHD Response Assessment Sandra A. Mitchell, CRNP, M.Sc.N., AOCN National Institutes of Health Bethesda, MD

2. 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

3. 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

4. Chronic GVHD-Specific Core Measures—Patient Self-Report Lee Chronic GVHD Symptom Scale

5. 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

6. 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).

7. Chronic GVHD Activity Assessment—Clinician Click here to open Appendix E: Response Criteria Evaluation form—Clinician

8. Chronic GVHD Activity Assessment—Clinician Click here to open Appendix E: Response Criteria Evaluation form—Clinician

9. 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)

10. 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

11. Chronic GVHD Activity Assessment—Patient Self-Report Click here to open Appendix E: Response Criteria Evaluation Form—Patient

12. Proposed Measures (Forms A&B) MeasureClinician assessedPatient reported Core – Chronic GVHD Specific SignsOrgan specific measuresN/A Symptoms Clinician assessedPatient reported Lee Symptom Scale Global Rating7 point change scale 7 point change scale Mild-moderate-severeMild-moderate-severe 0-10 severity scale0-10 severity scale Ancillary - CGVHD Non-Specific FunctionGrip StrengthHAP 2 min walk timeASK (children) Performance statusKarnofsky/LanskyN/A Quality of lifeN/AFACT-BMT SF-36 v.2 CHRIs-HSCT (children)

13. 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

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