Table 3.
Strongly encouraged, exploratory, and no longer recommended response measures for general chronic GVHD trials
| Organ* | Strongly Encouraged | Exploratory | No longer recommended for general chronic GVHD studies |
|---|---|---|---|
| Skin | Clinician and patient reported skin and/or joint tightening | Body surface area of erythematous changes and moveable sclerosis Pigmentary changes |
|
| Eyes | Schirmer’s test | ||
| Mouth | Mucoceles, patient-reported mouth pain and dryness on a 0–10 scale | ||
| Upper GI | Weight | ||
| Lower GI | Weight | ||
| Liver | Aspartate aminotransferase | ||
| Lungs | Corrected DLCO, FVC, TLC, RV | ||
| Hematologic | Platelet count, absolute eosinophil count | ||
| Genitals | Female and male self-reported question: “Worse genital discomfort” on a 0–10 scale | ||
| Ancillary measures | SF-36v.2 (0–100) or FACT-BMT (0–148) in adults HAP (if the SF-36v2 is not used) (0–94) Patient overall severity score 0–10 |
PedsQL Clinician and patient-reported severity (0–10) and change (−3 to +3) for organ-specific chronic GVHD manifestations |
Grip strength Children’s Health Rating Inventory Activity Scale for Kids |
No measures for esophagus or joints and fascia
SF-36v2, Medical Outcome Study Short Form 36, version 2; FACT-BMT, Functional Assessment of Cancer Therapy-Bone Marrow Transplantation subscale; HAP, human activities profile; PedsQL, pediatric quality of life