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The task of 3D object detection poses a significant challenge for 3D scene understanding and is primarily employed in the fields of robot control and autonomous driving. Monocular-based 3D detection methods are more cost-effective and practical than stereo-based or LiDAR-based methods. Monocular image 3D detection methods have garnered considerable attention from researchers. However, the impact of occlusion scenarios of the objects on the keypoints prediction is often overlooked. To address this issue, the present paper proposes a novel 3D monocular object detection method named MonOAPC, which is equipped with occlusion-aware plane-constraints. This method can adaptively utilize partial keypoints to infer the plane location of the object based on the level of occlusion and highlights that the introduction of plane constraints is advantageous for the 3D detection task. First, the plane information of the object in 3D space is beneficial to optimize the keypoints regression, and considering that each plane holds different significance, an adaptive plane location inference module is proposed to enhance the keypoints location regression. Second, a novel co-depth estimation module is proposed to jointly estimate the object’s spatial location through various depth inference methods, thereby improving the generalization of the object depth estimation. Furthermore, the paper demonstrates that the accuracy of 3D object detection can be indirectly improved by introducing plane information to promote keypoints regression, and that plane information is effective for monocular 3D detection. The experimental outcomes show that the MonOAPC method can attain competitive results.

Late acute (LA) graft-versus-host disease (GVHD) is persistent, recurrent, or new-onset acute GVHD symptoms occurring >100 days after allogeneic hematopoietic cell transplantation (HCT). The aim of this analysis is to describe the onset, course, morbidity, and mortality of and examine angiogenic factors associated with LA GVHD. A prospective cohort of patients (n = 909) was enrolled as part of an observational study within the Chronic GVHD Consortium. Eighty-three patients (11%) developed LA GVHD at a median of 160 (interquartile range, 128-204) days after HCT. Although 51 out of 83 (61%) achieved complete or partial response to initial therapy by 28 days, median failure-free survival was only 7.1 months (95% confidence interval, 3.4-19.1 months), and estimated overall survival (OS) at 2 years was 56%. Given recently described alterations of circulating angiogenic factors in classic acute GVHD, we examined whether alterations in such factors could be identified in LA GVHD. We first tested cases (n = 55) and controls (n = 50) from the Chronic GVHD Consortium and then validated the findings in 37 cases from Mount Sinai Acute GVHD International Consortium. Plasma amphiregulin (AREG; an epidermal growth factor [EGF] receptor ligand) was elevated, and an AREG/EGF ratio at or above the median was associated with inferior OS and increased nonrelapse mortality in both cohorts. Elevation of AREG was detected in classic acute GVHD, but not chronic GVHD. These prospective data characterize the clinical course of LA GVHD and demonstrate alterations in angiogenic factors that make LA GVHD biologically distinct from chronic GVHD.

Late acute (LA) graft-versus-host disease (GVHD) is persistent, recurrent, or new-onset acute GVHD symptoms occurring >100 days after allogeneic hematopoietic cell transplantation (HCT). The aim of this analysis is to describe the onset, course, morbidity, and mortality of and examine angiogenic factors associated with LA GVHD. A prospective cohort of patients (n = 909) was enrolled as part of an observational study within the Chronic GVHD Consortium. Eighty-three patients (11%) developed LA GVHD at a median of 160 (interquartile range, 128-204) days after HCT. Although 51 out of 83 (61%) achieved complete or partial response to initial therapy by 28 days, median failure-free survival was only 7.1 months (95% confidence interval, 3.4-19.1 months), and estimated overall survival (OS) at 2 years was 56%. Given recently described alterations of circulating angiogenic factors in classic acute GVHD, we examined whether alterations in such factors could be identified in LA GVHD. We first tested cases (n = 55) and controls (n = 50) from the Chronic GVHD Consortium and then validated the findings in 37 cases from Mount Sinai Acute GVHD International Consortium. Plasma amphiregulin (AREG; an epidermal growth factor [EGF] receptor ligand) was elevated, and an AREG/EGF ratio at or above the median was associated with inferior OS and increased nonrelapse mortality in both cohorts. Elevation of AREG was detected in classic acute GVHD, but not chronic GVHD. These prospective data characterize the clinical course of LA GVHD and demonstrate alterations in angiogenic factors that make LA GVHD biologically distinct from chronic GVHD.

Chronic graft-versus-host disease (GVHD) is a pleotropic syndrome that lacks validated methods of measuring response in clinical trials, although several end points have been proposed. To investigate the prognostic significance of these proposed end points, such as the 2005 National Institutes of Health (NIH) response measures, 2014 NIH response measures, clinician-reported response, and patient-reported response, we tested their ability to predict subsequent overall survival (OS), nonrelapse mortality (NRM), and failure-free survival (FFS). Patients (n = 575) were enrolled on a prospective chronic GVHD observational trial. At 6 months, clinician-reported response (P = .004) and 2014 NIH-calculated response (P = .001) correlated with subsequent FFS, and clinician-reported response predicted OS (P = .007). Multivariate models were used to identify changes in organ involvement, laboratory values, and patient-reported outcomes that were associated with long-term outcomes. At 6 months, a change in the 2005 NIH 0 to 3 clinician-reported skin score and 0 to 10 patient-reported itching score predicted subsequent FFS. Change in the Lee skin symptom score and Functional Assessment of Cancer Therapy–Bone Marrow Transplant score predicted subsequent OS. Change in the Lee skin symptom score predicted subsequent NRM. This study provides evidence that clinician-reported response and patient-reported outcomes are predictive of long-term survival. The trial was registered at www.clinicaltrials.gov as #NCT00637689.

Chronic graft-versus-host disease (GVHD) is a pleotropic syndrome that lacks validated methods of measuring response in clinical trials, although several end points have been proposed. To investigate the prognostic significance of these proposed end points, such as the 2005 National Institutes of Health (NIH) response measures, 2014 NIH response measures, clinician-reported response, and patient-reported response, we tested their ability to predict subsequent overall survival (OS), nonrelapse mortality (NRM), and failure-free survival (FFS). Patients (n = 575) were enrolled on a prospective chronic GVHD observational trial. At 6 months, clinician-reported response (P= .004) and 2014 NIH-calculated response (P= .001) correlated with subsequent FFS, and clinician-reported response predicted OS (P= .007). Multivariate models were used to identify changes in organ involvement, laboratory values, and patient-reported outcomes that were associated with long-term outcomes. At 6 months, a change in the 2005 NIH 0 to 3 clinician-reported skin score and 0 to 10 patient-reported itching score predicted subsequent FFS. Change in the Lee skin symptom score and Functional Assessment of Cancer Therapy–Bone Marrow Transplant score predicted subsequent OS. Change in the Lee skin symptom score predicted subsequent NRM. This study provides evidence that clinician-reported response and patient-reported outcomes are predictive of long-term survival. The trial was registered at www.clinicaltrials.govas #NCT00637689.

There are no validated biomarkers for chronic GVHD (cGVHD). We used a protein microarray and subsequent sequential enzyme-linked immunosorbent assay to compare 17 patients with treatment-refractory de novo–onset cGVHD and 18 time-matched control patients without acute or chronic GVHD to identify 5 candidate proteins that distinguished cGVHD from no cGVHD: CXCL9, IL2Rα, elafin, CD13, and BAFF. We then assessed the discriminatory value of each protein individually and in composite panels in a validation cohort (n = 109). CXCL9 was found to have the highest discriminatory value with an area under the receiver operating characteristic curve of 0.83 (95% confidence interval, 0.74-0.91). CXCL9 plasma concentrations above the median were associated with a higher frequency of cGVHD even after adjustment for other factors related to developing cGVHD including age, diagnosis, donor source, and degree of HLA matching (71% vs 20%; P < .001). A separate validation cohort from a different transplant center (n = 211) confirmed that CXCL9 plasma concentrations above the median were associated with more frequent newly diagnosed cGVHD after adjusting for the aforementioned factors (84% vs 60%; P = .001). Our results confirm that CXCL9 is elevated in patients with newly diagnosed cGVHD.

There are no validated criteria to measure skin response in chronic GVHD. In a prospectively assembled, multicenter cohort of patients with chronic GVHD (N = 458), we looked for correlation of change in several different scales recommended by the National Institutes of Health (NIH) Consensus with clinician and patient perception of change and overall survival. Of the clinician scales, the NIH composite 0-3 skin score was the only one that correlated with both clinician and patient perception of improvement or worsening. Of the patient-reported scales, the skin subscale of the Lee Symptom Scale was the only one that correlated with both clinician and patient perception of improvement or worsening. At study entry, NIH skin score 3 and Lee skin symptom score > 15 were both associated with worse overall survival. Worsening of NIH skin score at 6 months was associated with worse overall survival. Improvement in the Lee skin symptom score at 6 months was associated with improved overall survival. Our findings support the use of the NIH composite 0-3 skin score and the Lee skin symptom score as simple and sensitive measures to evaluate skin involvement in clinical trials as well as in the clinical monitoring of patients with cutaneous chronic GVHD.

There are no validated criteria to measure skin response in chronic GVHD. In a prospectively assembled, multicenter cohort of patients with chronic GVHD (N = 458), we looked for correlation of change in several different scales recommended by the National Institutes of Health (NIH) Consensus with clinician and patient perception of change and overall survival. Of the clinician scales, the NIH composite 0-3 skin score was the only one that correlated with both clinician and patient perception of improvement or worsening. Of the patient-reported scales, the skin subscale of the Lee Symptom Scale was the only one that correlated with both clinician and patient perception of improvement or worsening. At study entry, NIH skin score 3 and Lee skin symptom score > 15 were both associated with worse overall survival. Worsening of NIH skin score at 6 months was associated with worse overall survival. Improvement in the Lee skin symptom score at 6 months was associated with improved overall survival. Our findings support the use of the NIH composite 0-3 skin score and the Lee skin symptom score as simple and sensitive measures to evaluate skin involvement in clinical trials as well as in the clinical monitoring of patients with cutaneous chronic GVHD.

In 2005, the National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic GVHD proposed a new scoring system for individual organs and an algorithm for calculating global severity (mild, moderate, severe). The Chronic GVHD Consortium was established to test these new criteria. This report includes the first 298 adult patients enrolled at 5 centers of the Consortium. Patients were assessed every 3-6 months using standardized forms recommended by the Consensus Conference. At the time of study enrollment, global chronic GVHD severity was mild in 10% (n = 32), moderate in 59% (n = 175), and severe in 31% (n = 91). Skin, lung, or eye scores determined the global severity score in the majority of cases, with the other 5 organs determining 16% of the global severity scores. Conventional risk factors predictive for onset of chronic GVHD and nonrelapse mortality in people with chronic GVHD were not associated with NIH global severity scores. Global severity scores at enrollment were associated with nonrelapse mortality (P < .0001) and survival (P < .0001); 2-year overall survival was 62% (severe), 86% (moderate), and 97% (mild). Patients with mild chronic GVHD have a good prognosis, while patients with severe chronic GVHD have a poor prognosis. This study was registered at www.clinicaltrials.gov as no. NCT00637689.

Quality of life (QOL) after hematopoietic cell transplantation (HCT) is compromised by chronic GVHD. In a prospectively assembled multicenter cohort of adults with chronic GVHD (n = 298), we examined the relationship between chronic GVHD severity defined by National Institutes of Health (NIH) criteria and QOL as measured by the SF-36 and FACT-BMT instruments at time of enrollment. Chronic GVHD severity was independently associated with QOL, adjusting for age. Compared with population normative data, SF-36 scores were more than a SD (10 points) lower on average for the summary physical component score (PCS) and role-physical subscale, and significantly lower (with magnitude 4-10 points) for several other subscales. Patients with moderate and severe cGVHD had PCS scores comparable with scores reported for systemic sclerosis, systemic lupus erythematosus, and multiple sclerosis, and greater impairment compared with common chronic conditions including diabetes, hypertension, and chronic lung disease. Moderate to severe cGVHD as defined by NIH criteria is associated with significant compromise in multiple QOL domains, with PCS scores in the range of other systemic autoimmune diseases. Compromised QOL provides a functional assessment of the effects of chronic GVHD, and may be measured in cGVHD clinical studies using either the SF-36 or the FACT-BMT.

Quality of life (QOL) after hematopoietic cell transplantation (HCT) is compromised by chronic GVHD. In a prospectively assembled multicenter cohort of adults with chronic GVHD (n = 298), we examined the relationship between chronic GVHD severity defined by National Institutes of Health (NIH) criteria and QOL as measured by the SF-36 and FACT-BMT instruments at time of enrollment. Chronic GVHD severity was independently associated with QOL, adjusting for age. Compared with population normative data, SF-36 scores were more than a SD (10 points) lower on average for the summary physical component score (PCS) and role-physical subscale, and significantly lower (with magnitude 4-10 points) for several other subscales. Patients with moderate and severe cGVHD had PCS scores comparable with scores reported for systemic sclerosis, systemic lupus erythematosus, and multiple sclerosis, and greater impairment compared with common chronic conditions including diabetes, hypertension, and chronic lung disease. Moderate to severe cGVHD as defined by NIH criteria is associated with significant compromise in multiple QOL domains, with PCS scores in the range of other systemic autoimmune diseases. Compromised QOL provides a functional assessment of the effects of chronic GVHD, and may be measured in cGVHD clinical studies using either the SF-36 or the FACT-BMT.

Older patients undergoing allogeneic stem cell transplantation may experience a higher degree of morbidity and limitations from transplant related complications. Chronic graft-versus –host disease (GVHD) causes a significant reduction in patients’ quality of life (QOL), physical functioning, and functional status. However, it is not known if moderate to severe chronic GVHD has a worse impact on QOL, or survival outcomes for older patients.We analyzed data of patients with moderate or severe chronic GVHD (N=522, 1661 follow-up visits, a total of 2,183 visits) from the Chronic GVHD Consortium, a prospective observational multicenter cohort. Moderate or severe chronic GVHD was defined by the National Institutes of Health global severity score at the time of enrollment. We examined the relationship between age group (adolescent and young adult “AYA” 18-40, “middle-aged” 41-59, and “older” ≥ 60 years) and clinical manifestations of chronic GVHD, patient-reported outcomes, functional status, non-relapse mortality and overall survival. Clinical manifestations of chronic GVHD were determined by the clinician-reported individual organ scores. Patient-reported outcomes included (1) QOL as measured by Functional Assessment of Cancer Therapy Bone Marrow Transplantation (FACT-BMT) and the Medical Outcome Short-Form Health Survey (SF-36) (2) chronic GVHD symptom burden as measured by the Lee Symptom Scale; and (3) physical fitness as measured by the Human Activity Profile (HAP). Functional status was assessed using the 2-minute walk test (2MWT). Because of multiple testing, p-values <0.01 were considered significant.There were 115 (22%) AYA, 279 (53%) middle-aged and 128 (25%) older patients with moderate (58%) or severe (42%) chronic GVHD included. At study enrollment, older patients (≥60) were similar to younger patients in sex, time from transplant (median 12 months), prior acute GVHD, percentage of severe chronic GVHD, and current co-morbidity scores but differed in disease distribution and conditioning regimen intensity. At enrollment, in unadjusted analyses using all available data, older patients had similar rates and severity of global and organ-specific manifestations of chronic GVHD compared to younger patients, except for genital involvement, which was more prevalent and severe in AYA patients. Although older patients reported worse physical functioning [SF-36 Physical Functioning (p=0.01)], shorter 2MWT (p=0.002), and lower HAP scores (p=0.001) than AYA and middle-aged patients suggesting they have more physical limitations, older patients had better QOL [FACT-BMT (p=0.01)] scores compared to middle-aged patients and similar to AYA patients. Older patients had better psychological [Lee Psychological Scale (p<0.001), SF-36 Mental Health (p=0.01)] and emotional functioning [FACT-Emotional Well-being (p=0.001)] and less pain [SF-36 Bodily Pain (p=0.006)] than AYA and middle-aged patients but similar chronic GVHD symptom burden [Lee Symptom Scale (p=0.47)]. In multivariable linear mixed models utilizing all visit data and adjusted for clinical covariates, older patients had QOL (FACT-BMT) that was comparable to AYA patients (estimate -0.04, p=0.99) and better than middle-aged patients (estimate 5.7, p=0.004), while the SF36 physical and mental component scores and symptom burden were not different between the groups. Non-relapse mortality and overall survival were similar between the age groups in unadjusted analyses (p=0.23, p=0.17) and after adjusting for clinical covariates (p=0.17, p=0.15) in Cox models. In a subgroup analysis, we found that there were no differences in overall and organ-specific chronic GVHD manifestations, QOL and survival between patients in the 60-64 (n=73), 65-70 (n=39), and >70 (n=16) age groups, except for more moderate-severe skin involvement in the 65-70 year olds.Despite higher physical and functional limitations, older patients with moderate or severe chronic GVHD have preserved QOL, comparable disease manifestations and symptom burden, and similar overall survival and non-relapse mortality when compared to younger patients. Therefore we did not find evidence that older age itself is associated with worse QOL or survival in patients with moderate or severe chronic GVHD.No relevant conflicts of interest to declare.

The global severity score (GS) was devised by experts during the 2005 NIH Consensus for chronic graft-versus-host disease (GVHD) to reflect the overall severity of chronic GVHD at any time point. According to this scale, overall involvement is categorized as mild, moderate or severe. Several studies demonstrated that the NIH GS was associated with subsequent mortality in patients with chronic GVHD. We used multivariate time-varying analysis accounting for longitudinal changes of severity in individual organs over time to try to develop a better global mortality score than the NIH GS.

Data were derived from the Chronic GVHD Consortium, a prospective, multicenter, longitudinal, observational study. A total of 2202 visits from 574 adult patients with systemically treated chronic GVHD through January 2013 were used for analysis. At follow-up visits every 3-6 months, clinicians reported standardized information including NIH organ severity scores. Objective medical data including laboratory and pulmonary function test results were abstracted through standardized chart review after each visit. Time-varying Cox models accounting for varied times of entry into the study and longitudinal changes in organ severity over time were used to correlate severity in individual sites with overall mortality. All models were adjusted for time after transplantation, study site and known chronic GVHD mortality risk factors. 424 randomly selected patients with 1602 visit ratings were used to develop a new global mortality score, and the remaining 150 patients with 600 visit ratings were used to validate the model. Risk stratification was compared between the final model and the NIH GS model.In the training phase, multivariate models showed that organ severity scores in skin, gastrointestinal tract, liver and lung were independently associated with overall mortality (Table 1), while scores in mouth, eyes, joint or fascia and genital tract were not. Mortality scores were assigned based on observed hazard ratios, and 3 risk groups were identified based on the total mortality score (Table 2). In the validation cohort (n=150), the intermediate (329 visit ratings, HR 3.7, p=0.05) and high-risk categories (89 visit ratings, HR 10.8, p=0.001) were associated with higher risk of overall mortality compared with the low-risk category (185 visit ratings). Using the NIH GS instead, the severe category (196 visit ratings, HR 3.1, p=0.01) was associated with higher risk of overall mortality compared with the mild or moderate category (22 plus 382 visit ratings). Although agreement in risk categories was slight (weighted kappa = 0.32), the two models did not differ statistically based on log likelihood ratios, showing that they performed equally well in identifying groups with different mortality risks.The influence of organ scores on mortality differs according to individual sites, with the largest influence from lung followed by liver, skin and gastrointestinal tract. The model fitness did not differ statistically between the 2 models, suggesting that the NIH GS is an adequate model for risk stratification based on mortality in patients with chronic GVHD.No relevant conflicts of interest to declare.

Older patients undergoing allogeneic stem cell transplantation may experience a higher degree of morbidity and limitations from transplant related complications. Chronic graft-versus –host disease (GVHD) causes a significant reduction in patients' quality of life (QOL), physical functioning, and functional status. However, it is not known if moderate to severe chronic GVHD has a worse impact on QOL, or survival outcomes for older patients.

Chronic graft-versus-host disease (GVHD) is a significant source of morbidity, mortality, impaired patient-reported quality of life (QOL), greater symptom burden, and prolonged duration of immune suppressive therapy following allogeneic hematopoietic cell transplantation (HCT). While available data support the adverse prognosis of overlap subtype of chronic GVHD, the relative importance of site of gastrointestinal (GI) and type of hepatic involvement is not known.We analyzed prospectively acquired observational cohort data to examine whether the site of GI involvement (esophageal, upper GI, lower GI) and type of hepatic laboratory test abnormality (bilirubin, alkaline phosphatase (AP), alanine aminotransferase (ALT) elevation over the upper limit of normal based on study site-specific laboratory reference ranges) among chronic GVHD-affected patients are associated with overall survival (OS) and non-relapse mortality (NRM), symptoms (Lee Symptom Scale), and quality of life (QOL) per SF-36 and FACT-BMT instruments.This analysis included 567 individual subjects with baseline and 1548 follow up visits. The majority were incident cases (59%), adults (98%), and predominantly White/Non-Hispanic. Median time from HCT to cohort enrollment was 11.9 months (range 3–294 months). Overall NIH chronic GVHD severity was mild in 10%, moderate in 52%, and severe in 38% at enrollment. Prior acute GVHD was noted in 66%, KPS < 80% in 17%, and platelet count at chronic GVHD onset of < 100 K/uL in 23%. At enrollment, GI involvement was seen in 40% (upper GI 20%, esophagus 16%, lower GI 13%), and liver involvement was seen in 52% (AP 38%, ALT 38%, bilirubin 10%). Time from transplant to cGVHD onset was not different for patients with or without GI involvement or hepatic involvement. In multivariate analysis utilizing data from enrollment visits only and adjusting for patient and transplant variables, lower GI involvement (HR 1.7, p=0.03) and elevated bilirubin (HR 2.36, p=0.001) were associated with OS; both were also associated with NRM. In multivariable analysis using all visits (time-dependent covariates), GI score greater than zero (HR 1.7, p=0.01) and elevated bilirubin (HR 3.7, p<0.001) were associated with OS; results were similar for NRM. Separate models were constructed to examine the relationship of severity of GI and hepatic involvement (0–3 severity score per NIH consensus) and mortality: Increasing lower GI severity at enrollment was significantly associated with non-relapse mortality, with progressively increasing HR for greater severity levels (lower GI score 2/3 vs. 0: HR 5.5, 95% CI 2.3–13.1, p = 0.0001). Increasing bilirubin was also associated with NRM (bilirubin score 2/3 vs. 0: HR 3.3, 95% CI 1.3–8.4, p=0.01). A similar association was observed for bilirubin elevation and NRM in the time-dependent model (bilirubin 2/3 vs. 0: HR 8.9, 95% CI 3.3–24, p < 0.0001). When analyzing all visits, any esophageal involvement and GI score greater than zero were associated with both symptoms and QOL while elevated bilirubin was associated with QOL. We found no consistent evidence that upper GI involvement, AP, ALT, or NIH liver score add prognostic value for survival, overall symptom burden, or quality of life.These data support important differences in patient-reported outcomes according to GI and hepatic involvement among chronic GVHD affected patients, and identify those with elevated bilirubin or higher GI score at any time, or lower GI involvement at cohort enrollment, as patients at greater risk for mortality under current treatment approaches.No relevant conflicts of interest to declare.

Assessing joint chronic GVHD needs to be accomplished reliably, simply and in a clinically meaningful way. To determine the optimal tool for assessing joint GVHD, we evaluated 2 NIH recommended joint tools (Table), a photographic range of motion (P-ROM) scale, and 7 other NIH recommended tools (Lee symptom scale, 10-point overall symptoms, FACT-G, SF36, Human Activities Profile, walk test and grip test).Patients ≥ age 2 with systemically treated chronic GVHD ≤ 3 years after hematopoietic cell transplantation were eligible for a prospective multicenter observational study. Incident and prevalent cases were included. At follow-up visits every 3–6 months, the clinician (MD) and patient (PT) rated separately their perception of change in joint GVHD on an 8-pt scale, which was collapsed into improved, stable or worse categories. Linear mixed models were used to correlate change in each tool with MD or PT-perceived change (improved vs. stable or worse vs. stable) in joint GVHD status.Nine sites in the Consortium enrolled 567 participants through December 2011. Joint involvement, as defined by NIH joint/fascia score ≥1, was present at enrollment in 164 (29%) patients and included wrists (64%), ankles (47%), shoulders (35%) and elbows (30%). Joint involvement at enrollment was associated with longer duration of chronic GVHD, high-dose total body irradiation, higher symptom burden, lower quality of life (QOL), similar activity profile and similar physical function, compared to those without joint involvement. Change in joint GVHD status was examined for 652 paired visits when joint involvement was documented in the previous or current visit. In the later visits, both MDs and PTs more often reported improvement (44% and 45%) than worsening (5% and 11%). Tools that correlated with both MD and PT-perceived joint improvement were NIH joint/fascia score, Hopkins fascia score and SF36-PCS. Tools that correlated with both MD and PT-perceived joint worsening were P-ROM total score, NIH joint/fascia score, Hopkins fascia score, Lee muscle/joint subscale, Lee symptom overall score, 10-point overall symptoms and FACT-G. Among the 3 joint/fascia tools (Figure), for MD-perceived improvement, estimated change in the NIH score and P-ROM score was slightly larger than in the Hopkins score. For PT-perceived improvement, estimated change was similar for NIH and Hopkins scores. In contrast, for both MD and PT-perceived worsening, estimated change for the P-ROM score was significantly larger than in the other tools.Joint involvement with chronic GVHD is frequent and associated with increased symptom burden and decreased QOL. Our results support the combined use of NIH joint/fascia score and P-ROM scale to assess joint GVHD. The NIH score better reflects joint improvement and the P-ROM scale better reflects joint worsening. The more objective P-ROM scale is insensitive to PT-perceived joint improvement possibly because unlike the other two joint assessment tools, it does not incorporate tightness with or without activities of daily living.No relevant conflicts of interest to declare.

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No relevant conflicts of interest to declare.

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No relevant conflicts of interest to declare.

Miklos: Novartis: Honoraria, Research Funding.

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Patients ≥ age 2 diagnosed with cGVHD within 3 years after allogeneic hematopoietic cell transplantation requiring systemic treatment were eligible. Providers and patients complete multiple cGVHD assessment tools at study entry and every 3-6 months. The NIH scale grades 8 body regions according to the percent of body surface area (BSA) involvement by 3 manifestations: 1) erythematous rash, 2) moveable sclerosis, and 3) non-moveable sclerosis, with possible values of 0-100% total BSA for each manifestation. The VS scores each of 10 body regions with percentage involvement of 4 types of skin manifestations: 1 = hypo/hyperpigmentation, erythematous rash, 2 = lichenoid plaque, thickening, able to move, 3 = thickened, limited motion, pinchable, 4 = hidebound, unable to move or pinch. For areas scored as 3 or 4, concurrent fraction involved with erythema is also recorded. Regional scores are summed for a Vienna Skin Total (VST) score of 0-50. At follow-up visits patients and providers rated change in skin involvement as improved, stable, or worse. Proportional odds regression was used to predict improved, stable and worse rates using the difference in NIH subscales or VST since the last visit (change scores). Predictive ability for each scale was summarized using the c index of concordance.Of the 229 participants as of 4/30/09, 61% were males, the median age was 52 years (2-79) and median time from transplant to study entry was 393 days (91-1233). Table 1 shows the scores on the two scales for patients with any skin involvement at baseline (n=161, 70%). At 168 follow-up visits with NIH and VS data, skin GVHD was rated by the providers as improved, stable, or worse in 43%, 48%, and 9%, respectively. Both tools appeared to predict subjective change with the c index of concordance of 0.76 for NIH and 0.71 for VS. Compared to providers, patients were more likely to rate the skin as improved (56%), and less likely to report stable (38%) or worse (6%). The same differences (VST, and NIH erythema and non-moveable sclerosis) were still significant predictors of patients' subjective change. Concordance (c index) and parameter estimates (odds ratios) were attenuated compared to models of provider ratings.Results of the 4 models are summarized in Table 2.Skin involvement is frequent in cGVHD. Both NIH and VS scores are associated with provider- and patient-reported changes in skin severity. These results suggest that the NIH and VS tools are quantitative measures that are sensitive to provider and patient-perceived skin changes over time. Data from additional patients with a broader range of skin severity and longer follow up are needed to better define the roles of these scales as endpoints in clinical trials.Jagasia: Genzyme: Research Funding.

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