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Chronic GvHD, PRO and health status
participate, thus potentially biasing our results and leading to an inability to differentiate moderate from severe chronic GvHD. This hypothesis is supported by a lack of difference in the frequency of well-known steroid-associ- ated complications such as avascular necrosis and dia- betes. Additional studies to show that the range of the PROMIS measures is sufficiently sensitive for patients with extreme levels of dysfunction are necessary. Nevertheless, we were able to show significantly compro- mised QOL and functional status for patients with moder- ate or severe chronic GvHD, and the PROMIS measures were able to detect differences between chronic GvHD categories. Another limitation is that the analysis is based on self-reported chronic GvHD severity since most patients did not have a recent clinical severity assessment by a transplant expert. Unfortunately we do not have con- current clinician-assessed or NIH-classified severity infor- mation for this population. Finally, because this is a cross- sectional study, patients were analyzed according to their self-reported category at the time of the survey. A longi- tudinal study is needed to confirm that patients who move from moderate-severe to resolved chronic GvHD have improved QOL, ideally, similar to those who had no or mild chronic GvHD. This information would be
encouraging to patients currently being treated for chron- ic GvHD.
In conclusion, among patients with current chronic GvHD, moderate to severe chronic GvHD is associated with worse QOL scores whether measured by the SF-36, PROMIS Global Health, PROMIS-29 or LSS, and the SF-36 and PROMIS measures provide comparable score profiles. Prevention or better treatment of moderate to severe chronic GvHD is important in order to minimize adverse effects on QOL and health status for allogeneic transplant survivors. Patients whose chronic GvHD resolves appear similar to those who have never had chronic GvHD, except that they continue to have statistically but not clin- ically worse mouth, eye, nutritional and overall chronic GvHD symptoms. The freely available, concise and flexi- ble PROMIS Global Health and PROMIS-29 measures seem to perform as well as the SF-36 in capturing the multi-dimensional QOL of these patients.26 Thus any of these multi-dimensional measures could be used along with the LSS for assessing QOL in HCT clinical trials.
Acknowledgment
This work was supported by the U.S. National Institutes of Health (grants CA018029, CA215134, and CA118953).
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