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Predictive models for ocular chronic graft-versus-host disease diagnosis and disease activity in transplant clinical
Lauren M Curtis1, Manuel B Datiles2, Seth M Steinberg3
1Experimental Transplantation and Immunology Branch, National Cancer institute (NCI), National Institutes of Health (NIH), Bethesda, MD, USA.
Insights
Ocular chronic graft-versus-host disease (cGVHD) screening can be improved using clinician and patient-reported outcomes. The NIH Eye Score and Schirmer
Area of Science:
- Ophthalmology
- Hematology
- Immunology
Background:
- Ocular chronic graft-versus-host disease (cGVHD) is a common complication after allogeneic hematopoietic stem cell transplantation (HSCT).
- Current diagnostic criteria and activity definitions for ocular cGVHD are lacking, necessitating improved clinical tools.
- The National Institutes of Health (NIH) Chronic Graft-versus-Host Disease Consensus Project offers recommendations but requires ophthalmologist examination for diagnosis.
Purpose of the Study:
- To identify predictive models for the diagnosis and activity of ocular cGVHD in HSCT survivors.
- To evaluate the utility of transplant clinician- and patient-reported outcome measures for ocular cGVHD screening.
- To establish reliable screening tools for early detection and management of ocular cGVHD.
Main Methods:
- A prospective, cross-sectional, observational study of 210 patients with moderate to severe cGVHD.
- Ophthalmologists assessed ocular cGVHD presence, diagnosis, and activity.
- Measures included Schirmer's tear test, NIH 0-3 Eye Score, Lee cGVHD Symptom Scale ocular subscale, and Chief Eye Symptom Intensity Score.
Main Results:
- 157 patients (75%) were diagnosed with ocular cGVHD; 133 (85%) had active disease.
- NIH Eye Score and Schirmer's tear test independently predicted ocular cGVHD diagnosis (93.0% sensitivity, 92.2% specificity).
- The Lee ocular subscale best predicted active ocular cGVHD (68.5% sensitivity, 82.6% specificity).
Conclusions:
- Selected transplant clinician- and patient-reported outcome measures can effectively screen for ocular cGVHD in HSCT survivors.
- The NIH Eye Score and Schirmer's tear test are valuable predictors for diagnosing ocular cGVHD.
- Further prospective studies are needed to validate the Lee ocular subscale's responsiveness for disease activity monitoring.
Abstract:
Ocular chronic graft-versus-host disease is one of the most bothersome common complications following allogeneic hematopoietic stem cell transplantation. The National Institutes of Health Chronic Graft-versus-Host Disease Consensus Project provided expert recommendations for diagnosis and organ severity scoring. However, ocular chronic graft-versus-host disease can be diagnosed only after examination by an ophthalmologist. There are no currently accepted definitions of ocular chronic graft-versus-host disease activity. The goal of this study was to identify predictive models of diagnosis and activity for use in clinical transplant practice. A total of 210 patients with moderate or severe chronic graft-versus-host disease were enrolled in a prospective, cross-sectional, observational study (clinicaltrials.gov identifier: 00092235). Experienced ophthalmologists determined presence of ocular chronic graft-versus-host disease, diagnosis and activity. Measures gathered by the transplant clinician included Schirmer's tear test and National Institutes of Health 0-3 Eye Score. Patient-reported outcome measures were the ocular subscale of the Lee Chronic Graft-versus-Host Disease Symptom Scale and Chief Eye Symptom Intensity Score. Altogether, 157 (75%) patients were diagnosed with ocular chronic graft-versus-host disease; 133 of 157 patients (85%) had active disease. In a multivariable model, the National Institutes of Health Eye Score (P<0.0001) and Schirmer's tear test (P<0.0001) were independent predictors of ocular chronic graft-versus-host disease (sensitivity 93.0%, specificity 92.2%). The Lee ocular subscale was the strongest predictor of active ocular chronic graft-versus-host disease (P<0.0001) (sensitivity 68.5%, specificity 82.6%). Ophthalmology specialist measures that were most strongly predictive of diagnosis in a multivariate model were Oxford grand total staining (P<0.0001) and meibomian score (P=0.027). These results support the use of selected transplant clinician- and patient-reported outcome measures for ocular chronic graft-versus-host disease screening when providing care to allogeneic hematopoietic stem cell transplantation survivors with moderate to severe chronic graft-versus-host disease. Prospective studies are needed to determine if the Lee ocular subscale demonstrates adequate responsiveness as a disease activity outcome measure.
