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S.J. Lee et al.
dictors of QOL scores even after adjustment for sex, age, conditioning intensity, total body irradiation, prior relapse, donor and graft type and an abbreviated comorbidity score. Patients with any degree of chronic GvHD reported worse health and a greater symptom burden than patients with resolved chronic GvHD (Table 3).
Table 4 shows health status according to chronic GvHD category. In general, the groups of patients differed signifi- cantly in self-reported Karnofsky performance status, organs still affected by chronic GvHD, diagnosis of osteopenia or osteoporosis and adrenal insufficiency, use of prednisone, other immunosuppressive medications and antibiotics to prevent infections, use of medications to pre- vent or treat osteoporosis, and prescription medication use for pain, anxiety and depression. Patients with active mild, moderate or severe chronic GvHD were less likely to work, be in school or be homemakers due to their health problems. No differences were detected in the proportions of patients with self-reported pulmonary disease, avascu- lar necrosis or diabetes.
Discussion
The goal of this study was to describe the QOL scores and health status among patients with active chronic
GvHD of differing severity and compare them to those of patients with resolved chronic GvHD or those who had never had chronic GvHD, with an emphasis on the PROMIS measures relative to the SF-36. Patients with resolved chronic GVHD reported QOL similar to patients who had never had chronic GvHD for most instruments, although they continued to have more mouth, eye, nutri- tional and overall symptoms. Among patients with current chronic GvHD, moderate or severe chronic GVHD was associated with worse patient-reported outcomes than mild disease for all QOL and symptom measures, confirming that PROMIS measures can detect these differences and are comparable to established measures of the impact of chron- ic GvHD on QOL.
A previous 2006 study found similar QOL in patients without chronic GvHD and those whose chronic GvHD had resolved.25 Our findings confirm this observation and extend it by including a number of validated multidimen- sional QOL instruments and other measures of health sta- tus. These observations suggest that prevention and treat- ment of moderate-severe chronic GvHD rather than mild disease should be targeted in clinical trials. In support of this recommendation is our finding that patients with moderate or severe chronic GvHD were much more likely to still require immunosuppressive treatment and to be taking pre- scription medication for pain, anxiety and depression. Our
Table 2. Mean scores (standard deviation) for summary and subscale measures.
Type of chronic graft-versus-host disease No active chronic GVHD
Active chronic GVHD Severe
Instrument
N
PROMIS Global Health
PROMIS 29
Short Form - 36
Lee symptom scale
Subscale
Physical Mental
Physical Social Anxiety Depression Fatigue Sleep
Pain
PCS
MCS
Physical
Role physical Mental health Role emotional Social
Vitality
Pain
General health
Summary Skin
Mouth
Eye
Vitality
Lung Nutrition Psychological
Never Resolved
P-value: never vs. resolved
Pvalue: Clinically Mild vs. meaningful moderate difference*
vs. severe
<0.001 4.7
<0.001 4.7
<0.001 4.5 <0.001 4.7 <0.001 4.2 <0.001 3.8 <0.001 5.2
0.010 4.4
<0.001 4.3
<0.001 5.5 <0.001 4.9 <0.001 5.3 <0.001 5.8 <0.001 4.5
0.002 5.3 <0.001 5.4 <0.001 5.5 <0.001 5.1 <0.001 5.9
<0.001 5.3 <0.001 6.6 <0.001 8.9 <0.001 14.7 <0.001 9.5 <0.001 4.2 <0.001 3.5 <0.001 9.3
375
52.6 (9.3) 52.9 (9.2)
50.4 (8.4) 55.3 (9.1) 47.1 (8.2) 46.4 (7.6) 46.5 (10.5) 47.1 (9.1) 48.0 (8.4)
49.6 (10.1) 52.9 (9.2) 49.7 (9.6) 49.0 (10.5) 54.1 (8.1) 50.2 (9.9) 50.5 (9.5) 53.4 (10.6) 52.5 (9.8) 49.8 (11.1)
8.5 (7.4) 5.4 (9.3) 2.0 (7.7) 15.5 (20.4) 18.0 (17.4) 3.2 (7.3) 1.3 (3.3) 14.5 (17.8)
282
52.9 (8.9) 53.0 (9.4)
51.1 (8.0) 55.7 (8.8) 46.5 (8.0) 45.3 (6.5) 46.6 (9.7) 46.9 (8.6) 47.9 (8.3)
49.3 (10.2) 53.4 (8.8) 49.4 (9.5) 49.2 (10.3) 53.6 (8.6) 50.6 (9.2) 50.4 (9.7) 53.8 (10.0) 51.8 (9.7) 49.8 (10.7)
11.1 (8.7) 6.1 (9.8) 4.5 (12.5) 28.3 (27.4) 19.0 (18.0) 3.6 (7.2) 2.4 (6.2) 14.2 (17.1)
0.750 0.913
0.378 0.593 0.459 0.074 0.858 0.761 0.876
0.655 0.516 0.760 0.830 0.442 0.616 0.893 0.605 0.342 0.958
<.001 0.387 0.004 <.001 0.468 0.454 <.001 0.296
Mild
257
48.4 (8.0) 49.4 (8.6)
47.1 (9.2) 51.1 (9.0) 48.7 (8.1) 47.0 (7.2) 49.8 (10.1) 48.5 (8.3) 49.7 (9.0)
44.5 (10.8) 50.7 (9.8) 46.0 (10.5) 43.6 (11.9) 51.5 (9.1) 48.0 (11.1) 46.3 (11.3) 49.9 (10.9) 49.7 (10.0) 43.8 (10.9)
16.2 (9.6) 11.1 (14.4) 13.7 (20.2) 36.5 (30.0) 24.9 (17.5) 4.9 (8.6) 3.7 (6.7) 18.0 (17.5)
Moderate
110
42.3 (6.8) 44.7 (7.6)
41.7 (7.7) 46.3 (7.7) 52.9 (9.0) 52.2 (8.8) 55.1 (8.3) 51.0 (8.3) 53.9 (8.3)
38.1 (10.1) 47.8 (10.6) 40.5 (10.6) 38.7 (11.6) 47.9 (9.3) 44.9 (12.0) 41.9 (11.3) 44.8 (9.4) 43.8 (9.7) 37.3 (10.1)
26.2 (11.1) 20.4 (17.6) 26.0 (28.7) 56.5 (30.9) 37.4 (18.8) 8.3 (10.3) 8.0 (12.3) 26.0 (21.7)
25
42.0 (8.9) 42.2 (8.7)
40.9 (11.1) 46.2 (11.5) 54.6 (9.4) 51.4 (9.2) 55.5 (10.3) 52.8 (7.2) 51.7 (8.9)
36.2 (12.1) 42.9 (13.6) 36.1 (13.2) 34.0 (12.6) 44.8 (11.1) 40.2 (15.8) 37.9 (13.0) 39.7 (12.1) 46.5 (11.9) 35.1 (11.3)
26.9 (11.6) 22.3 (18.7) 12.5 (19.4) 57.5 (31.5) 43.9 (22.6) 13.0 (16.3) 6.5 (12.8) 32.5 (23.6)
PCS: physical component score; MCS: mental component score. * 0.5 x standard 0.5 x standard deviation difference compared to patients whose chronic GvHD
deviation of the entire study population. Bold values are clinically significant, as defined by a greater than had resolved.
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