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Objectives To mitigate waiting time forlivertransplant for hepatocellular carcinoma, partial or split liver transplant has been utilized. There was concern that regeneration of these grafts would negatively affect oncologic outcomes. Materials and methods We compared posttransplant graft survival between hepatocellular carcinoma whole livertransplant and partial/splitlivertransplant using Scientific Registry of Transplant Recipients data (2002-2017). The 330 partial/split liver transplant recipients were compared with a logistic regressionbased propensity score 1:1 matched whole liver transplant cohort (n = 330) and a random unmatched whole livertransplant cohort(n = 4143). Kaplan-Meier and multivariable Cox regression models evaluated the effects of partial/split and whole liver transplant on survival. Results Unadjusted analysis demonstrated no difference in graft survivalbetween thepartial/split and whole liver transplant cohorts (overall log-rank P = .78). After adjustments for recipient age, last laboratory Modelfor End-stage LiverDisease score, hepatitisBviral infection co-diagnosis, liver donor risk index, donor historyofdiabetes, anddonorbodymass index category were made (all P ⟨ .05), multivariable analysis demonstrated no statistically significant difference in the risk of graftfailure in thepartial/splitlivertransplant cohort compared with either the matched or random whole livertransplant cohort (both P ≥ .23). Conclusions Partial/split liver transplant was not an independent risk factor for graft failure. Additional studies are needed to further elucidate differences in these populations to determine the "right" candidate for partial/split liver transplant.

Societal factors that influence wait-listing for transplantation are complex and poorly understood. Social determinants of health (SDOH) affect rates of and outcomes after transplantation.This cross-sectional study investigated the impact of SDOH on additions to state-level, 2017-2018 kidney and liver wait-lists. Principal components analysis, starting with 127 variables among 3142 counties, was used to derive novel, comprehensive state-level composites, designated (1) health/economics and (2) community capital/urbanicity. Stepwise multivariate linear regression with backwards elimination (n = 51; 50 states and DC) tested the effects of these composites, Medicaid expansion, and center density on adult disease burden-adjusted wait-list additions.SDOH related to increased community capital/urbanicity were independently associated with wait-listing (starting models: B = .40, P = .010 Kidney; B = .36, P = .038 Liver) (final models: B = .31, P = .027 Kidney, B = .34, P = .015 Liver). In contrast and surprisingly, no other covariates were associated with wait-listing (P ≥ .122).These results suggest that deficits in community resources are important contributors to disparities in wait-list access. Our composite SDOH metrics may help identify at-risk communities, which can be the focus of local and national policy initiatives to improve access to organ transplantation.

OBJECTIVES Previous studies of liver transplant recipients have reported discrepancies with regard to gender and/or sex differences but have focused on pretransplant outcomes. Female candidates are less likely to receive liver transplant and more likely to die or be delisted than their male counterparts. Here, we examined differences in men versus women with alcoholic liver disease before liver transplant and the effects of these differences on posttransplant survival. MATERIALS AND METHODS We analyzed the Scientific Registry of Transplant Recipients records of adult, deceased-donor, whole liver transplant recipients with decompensated alcoholic liver disease from 2002 to 2017 to evaluate the effects of gender on survival in 2 alcoholic liver disease cohorts: (a) including and (b) excluding recipients with additional diagnoses. Pretransplant characteristics were compared using chi-square or t tests. Kaplan-Meier and multivariable proportional hazards regression models were used to evaluate the main and covariable-adjusted effects of gender on survival. RESULTS Of 13781 transplant recipients with decompensated end-stage liver disease, as defined by Model for End-Stage Liver Disease score ≥ 15, 10924 (79%) were men and 2857 (21%) were women. Women had higher Model for End-Stage Liver Disease scores, higher rates of stage 4 and 5 chronic kidney disease, and were more likely to be on dialysis or ventilator support at time of transplant (all P < .05). Among all recipients, and after adjusting for risk factors, men were approximately 9% more likely than women to experience long-term graft loss (hazard ratio = 1.093; 95% confidence interval, 1.00-1.19; P = .043). However, sex difference was not associated with risk of graft loss among those without additional diagnoses (hazard ratio = 1.09; 95% confidence interval, 0.99-1.21; P = .095). CONCLUSIONS Although women with alcoholic liver disease who undergo liver transplant have higher severity of illness than their male counterparts, long-term outcomes are comparable.

Despite the divergent disease biology of cholangiocarcinoma (CCA) and hepatocellular carcinoma (HCC), wait-list prioritization is identical for both diagnoses. We compared wait-list and posttransplant outcomes between CCA and HCC liver transplantation patients with Model for End-Stage Liver Disease exceptions using Scientific Registry of Transplant Recipients data. The 408 CCA candidates listed between 2003 and mid-2017 were matched to 2 HCC cohorts by listing date (±2 months, n = 816) and by Organ Procurement and Transplantation Network (OPTN) region and date (±6 months, n = 408). Cumulative incidence competing risk regression examined the effects of diagnosis, OPTN region, and center-level CCA listing volume on wait-list removal due to death/being too ill (dropout). Cox models evaluated the effects of diagnosis, OPTN region, center-level CCA volume, and waiting time on graft failure among deceased donor liver transplantation (DDLT) recipients. After adjusting for OPTN region and CCA listing volume (all P ≥ 0.07), both HCC cohorts had a reduced likelihood of wait-list dropout compared with CCA candidates (HCC with period matching only: subdistribution hazard ratio [SHR] = 0.63; 95% CI, 0.43-0.93; P = 0.02 and HCC with OPTN region and period matching: SHR = 0.60; 95% CI, 0.41-0.87; P = 0.007). The cumulative incidence rates of wait-list dropout at 6 and 12 months were 13.2% (95% CI, 10.0%-17.0%) and 23.9% (95% CI, 20.0%-29.0%) for CCA candidates, 7.3% (95% CI, 5.0%-10.0%) and 12.7% (95% CI, 10.0%-17.0%) for HCC candidates with region and listing date matching, and 7.1% (95% CI, 5.0%-9.0%) and 12.6% (95% CI, 10.0%-15.0%) for HCC candidates with listing date matching only. Additionally, HCC DDLT recipients had a 57% reduced risk of graft failure compared with CCA recipients (P

PurposeThe EPIC-26 (Expanded Prostate Cancer Index Composite-Short Form) is a validated questionnaire for measuring health related quality of life. However, the relationship between domain scores and functional outcomes remains unclear, leading to potential confusion about expectations after treatment. For instance, does a sexual function domain score of 80 mean that a patient can achieve erection sufficient for intercourse? Consequently we sought to determine the relationship between the domain score and the response to obtaining the best possible outcome for each question.Materials and methodsUsing data from the CEASAR (Comparative Effectiveness Analysis of Surgery and Radiation) study, a multicenter, prospective study of men diagnosed with localized prostate cancer, we analyzed 11,464 EPIC-26 questionnaires from a total of 2,563 men at baseline through 60 months of followup who were treated with robotic prostatectomy, radiotherapy or active surveillance. We dichotomized every item into its best possible outcome and assessed the percent of men at each domain score who achieved the best result.ResultsFor every EPIC-26 item the frequency of the best possible outcome was reported by domain score category. For example, a score of 80 to 100 on sexual function corresponded to 97% of men reporting erections sufficient for intercourse while at a score of 40 to 60 only 28% reported adequate erections. Also, at a score of 80 to 100 on the urinary incontinence domain 93% of men reported rarely or never leaking vs 6% at a score of 61 to 80.ConclusionsOur findings indicate a novel way to interpret EPIC-26 domain scores, demonstrating large variations in the percent of respondents reporting the best possible outcomes over narrow domain score differences. This information may be valuable when counseling men on treatment options.

Patients with advanced kidney disease are at risk for cognitive impairment, which may persist after kidney transplantation. We sought to understand changes in neurocognitive function domains utilizing comprehensive cognitive assessments.Prospective cohort study.Single-center study of patients undergoing kidney transplantation.Kidney transplantation.Changes in neurocognitive function as measured by the Repeatable Battery for Assessment of Neuropsychological Status (RBANS) and the Trail Making Test Parts A and B (TRAIL A and B) before transplantation (baseline) and compared to 3 months and 12 months posttransplant.Wilcoxon signed-rank and linear mixed effect models were utilized to assess changes in neurocognitive scores at 3 months and 12 months compared to baseline.Thirty-two patients were included with a mean age of 45 years, 47% female, 85% White, and 62% with at least some college education. Hypertension and diabetes were etiologies of kidney disease in 31% and 25% of patients, respectively. Baseline RBANS and TRAIL A and B scores averaged 84.7 ± 14, 40.4 ± 9.9, and 41 ± 11.5, respectively. Although there were posttransplant improvements in immediate and delayed memory at 3 months, these were not sustained at 12 months. There were no significant differences from baseline at 3 months and 12 months in RBANS index scores for language, visuospatial/constructional abilities, and attention. Compared to baseline, TRAIL A scores were not significantly different at 3 months but were significantly improved at 12 months, whereas TRAIL B scores improved significantly at both 3 months and 12 months.Single-center design and small sample size.Utilizing comprehensive cognitive assessments, we found improvements in attention and executive function in the first posttransplant year as measured by TRAIL A and B. However, there was no significant change in global cognition as measured by RBANS. These findings identify cognitive domains for potential intervention in the posttransplant population.

Background: In the non-transplant population, hyperlipidaemia has shifted from targeting LDL goals to statin intensity-based treatment. It is unknown whether this strategy is also beneficial in cardiac transplantation. Methods: This single-centre retrospective study evaluated the effect of statin use and intensity on time to cardiac allograft vasculopathy (CAV) after cardiac transplantation. Kaplan–Meier and Cox proportional hazards regression survival methods were used to assess the association of statin intensity and median post-transplant LDL on CAV-free survival. Results: The study involved 143 adults (71% men, average follow-up of 25 ± 14 months) who underwent transplant between 2013 and 2017. Mean CAV-free survival was 47.5 months (95% CI [43.1–51.8]), with 29 patients having CAV grade 1 or greater. Median LDL was not associated with time to CAV (p=0.790). CAV-free survival did not differ between intensity groups (p=0.435). Conclusion: Given the non-statistically significant difference in time to CAV with higher intensity statins, the data suggest that advancing moderate- or high-intensity statin after cardiac transplantation may not provide additional long-term clinical benefit. Trial registration: Not applicable.

Background. Transplantation of hepatitis C viremic (HCV+) deceased donor kidney transplants (DDKT) into aviremic (HCV–) recipients is a strategy to increase organ utilization. However, there are concerns around inferior recipient outcomes due to delayed initiation of direct-acting antiviral (DAA) therapy and sustained HCV replication when implemented outside of a research setting. Methods. This was a retrospective single-center matched cohort study of DDKT recipients of HCV+ donors (cases) who were matched 1:1 to recipients of HCV– donors (comparators) by age, gender, race, presence of diabetes, kidney donor profile index, and calculated panel-reactive antibody. Data were analyzed using summary statistics, t-tests, and chi-square tests for between-group comparisons, and linear mixed-effects models for longitudinal data. Results. Each group consisted of 50 recipients with no significant differences in baseline characteristics. The 6-mo longitudinal trajectory of serum creatinine and estimated glomerular filtration rate did not differ between groups. All recipients had similar rates of acute rejection and readmissions (all P > 0.05). One case lost the allograft 151 d posttransplant because of acute rejection, and 1 comparator died on postoperative day 7 from cardiac arrest. HCV+ recipients initiated DAA on average 29 ± 11 d posttransplant. Ninety-eight percent achieved sustained virologic response at 4 and 12 wks with the first course of therapy; 1 patient had persistent HCV infection and was cured with a second course of DAA. Conclusions. Aviremic recipients of HCV+ DDKT with delayed DAA initiation posttransplant had similar short-term outcomes compared with matched recipient comparators of HCV– donors.

Supplemental Digital Content is available in the text., Background. While liver transplantation (LT) with neoadjuvant chemoradiation is increasingly utilized for the management of unresectable cholangiocarcinoma (CCA), data on post-LT survival are limited. Methods. We identified 844 patients who underwent LT (2002–2019) for nonincidental (CCA listing) or incidental (CCA on explant, not at listing) CCA in the Scientific Registry of Transplant Recipients. Kaplan–Meier and multivariable proportional hazards regression methods evaluated the effects of patient characteristics, donor type, transplant era (before/after 2010), and center volume (center-level CCALTs/active year) on the risk of graft failure and patient mortality. Results. One center performed >12 CCALTs/y, and the rest performed ≤4. Five-year graft survival was 50.6%. Multivariable models demonstrated laboratory model of end-stage liver disease ≥40 versus 1 to ≤2, and >2 to ≤4 CCALTs/y compared to >12 were associated with increased risk of graft failure and mortality (all P ≤ 0.002). Extra vessel use was associated with center volume. Among all recipients, extra vessel use occurred in 55.4% of CCALTs performed at the highest volume center and in 14.0% of cases at centers having ≤4 CCAs/y (P < 0.05). Conclusions. Center volume-related differences in outcomes and extra vessel use highlight the importance of establishing a unified, effective treatment protocol and the potential utility of regionalization of LT for CCA.

BACKGROUND: As the organ-shortage crisis continues to worsen, many patients in need of a kidney transplant have turned to social media to find a living donor. The effect of social media on living kidney donation is not known. The goal of this study is to investigate the influence of social media on those interested in donating a kidney. METHODS: Self-referrals for living kidney donation from December 2016 to March 2019 were retrospectively reviewed. Age, sex, race, and relationship of individuals petitioned through social media (SM) were compared with those petitioned through verbal communication (VC). Data were analyzed using chi-squared tests, with z tests of column proportions, and multivariable logistic regression. RESULTS: A total of 7817 individuals (53% SM, 36% VC, and 10% other) were self-referred for living kidney donation. The analysis sample included 6737 adults petitioned through SM (n=3999) or VC (n=2738). Half (n=3933) of the individuals reported an altruistic relationship, and 94% of these respondents were petitioned through SM. Although univariate analyses indicated that SM respondents were younger, more likely female, more likely White, and more likely to have directed altruistic intent than those petitioned through VC (all P

OBJECTIVE Attaining glycemic targets without severe hypoglycemic events (SHEs) is a challenging treatment goal for patients with type 1 diabetes complicated by impaired awareness of hypoglycemia (IAH). The CIT Consortium Protocol 07 (CIT-07) trial showed islet transplantation to be an effective treatment for subjects with IAH and intractable SHEs. We evaluated health-related quality of life (HRQOL), functional health status, and health utility before and after pancreatic islet transplantation in CIT-07 trial participants. RESEARCH DESIGN AND METHODS Four surveys, the Diabetes Distress Scale (DDS), the Hypoglycemic Fear Survey (HFS), the Short Form 36 Health Survey (SF-36), and the EuroQoL 5 Dimensions (EQ-5D), were administered repeatedly before and after islet transplantation. Summary statistics and longitudinal modeling were used to describe changes in survey scores from baseline and to characterize change in relation to a minimally important difference (MID) threshold of half an SD. RESULTS Improvements in condition-specific HRQOL met the MID threshold. Reductions from baseline in the DDS total score and its four DDS subscales (all P ≤ 0.0013) and in the HFS total score and its two subscales (all P < 0.0001) were observed across all time points. Improvements were observed after both 1 and 2 years for the EQ-5D visual analog scale (both P < 0.0001). CONCLUSIONS In CIT-07, 87.5% of the subjects achieved the primary end point of freedom from SHE along with glycemic control (HbA1c

Purpose The purpose of this study was to perform a comprehensive systematic review of the literature on voice-related patient-reported outcome (PRO) measures in adults and to evaluate each instrument for the presence of important measurement properties. Method MEDLINE, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument databases were searched using relevant vocabulary terms and key terms related to PRO measures and voice. Inclusion and exclusion criteria were developed in consultation with an expert panel. Three independent investigators assessed study methodology using criteria developed a priori. Measurement properties were examined and entered into evidence tables. Results A total of 3,744 studies assessing voice-related constructs were identified. This list was narrowed to 32 PRO measures on the basis of predetermined inclusion and exclusion criteria. Questionnaire measurement properties varied widely. Important thematic deficiencies were apparent: (a) lack of patient involvement in the item development process, (b) lack of robust construct validity, and (c) lack of clear interpretability and scaling. Conclusions PRO measures are a principal means of evaluating treatment effectiveness in voice-related conditions. Despite their prominence, available PRO measures have disparate methodological rigor. Care must be taken to understand the psychometric and measurement properties and the applicability of PRO measures before advocating for their use in clinical or research applications.

IntroductionPatient-reported outcome (PRO) measures are increasingly developed with multisite, representative patient populations so that they can serve as a primary endpoint in clinical trials and longitudinal studies. Creating multisite infrastructure during PRO measure development can facilitate future comparative effectiveness trials. We describe our protocol to simultaneously develop a PRO measure and create a collaborative of tertiary care centres to address the needs of patients with unilateral vocal fold paralysis (UVFP). We describe the stakeholder engagement, information technology and regulatory foundations for PRO measure development and how the process enables plans for multisite trials comparing treatments for this largely iatrogenic condition.Methods and analysisThe study has three phases: systematic review, measure development and measure validation. Systematic reviews and qualitative interviews (n=75) will inform the development of a conceptual framework. Qualitative interviews with patients with UVFP will characterise the lived experience of the condition. Candidate PRO measure items will be derivedverbatimfrom patient interviews and refined using cognitive interviews and expert input. The PRO measure will be administered to a large, multisite cohort of adult patients with UVFP via the CoPE (vocalCordParalysisExperience) Collaborative. We will establish CoPE to facilitate measure development and to create preliminary infrastructure for future trials, including online data capture, stakeholder engagement, and the identification of barriers and facilitators to participation. Classical test theory psychometrics and grounded theory characterise our approach, and validation includes assessment of latent structure, reliability and validity.Ethics and disseminationOur study is approved by the University of Wisconsin Health Sciences Institutional Review Board. Findings from this project will be published in open-access journals and presented at international conferences. Subsequent use of the PRO measure will include comparative effectiveness trials of treatments for UVFP at CoPE Collaborative sites.

BACKGROUND The 2014 pancreas allocation system (PAS) intended to decrease geographic variability in listing practices for simultaneous pancreas and kidney (SPK) transplant and define eligibility criteria for those with type 2 diabetes mellitus (T2DM). Our primary aims were to evaluate geographic disparities in access to SPK and assess T2DM SPK listings in the pre- and post-PAS eras. METHODS Adult listings for SPK and kidney transplant (pre-PAS, January 2010 to October 29, 2014; post-PAS, October 30, 2014, to June 2, 2017) were identified in the Scientific Registry of Transplant Recipients. Multivariable logistic regression models tested associations of geography and/or diabetes mellitus type on the likelihood of SPK versus kidney transplant listing pre- and post-PAS. Competing risk models tested the likelihood of SPK transplantation within 2 years of listing for SPK. RESULTS Among 41 205 listings (27 393 pre-PAS; 24 439 T2DM), univariate analysis showed reduced percentages for SPK post-PAS (22.1%-20.8%; P = 0.003). After adjusting for patient and center characteristics, geographic disparities declined slightly but persisted post-PAS (era by region interaction P < 0.001). The era by type of diabetes mellitus interaction effect was statistically significant (P = 0.039), reflecting that the proportions of SPK listings for T2DM increased in the post-PAS era (3.4%-3.9%; univariate P = 0.038), while those for type 1 diabetes mellitus remained statistically stable (47.9%-48.4%; univariate P = 0.571). Among people listed for SPK, geographic disparities in the cumulative incidence of transplantation within 2 years declined and the overall likelihood of transplantation increased in the post-PAS era (both P < 0.001). CONCLUSIONS Geographic disparities in access to SPK declined slightly but persisted post-PAS. With new allocation change proposals and elimination of listing criteria for T2DM, further monitoring is warranted.

The new kidney allocation systems (KAS) instituted December 2014 permitted A2 to B deceased donor kidney transplantation (DDKTx) to improve access and reduce disparities in wait time for minorities. A recent United Network for Organ Sharing (UNOS) analysis, however, indicated only 4.5% of B candidates were registered for A2 kidneys. Cited barriers to A2 to B DDKTx include titer thresholds, patient eligibility, and increased costs. There are little published data on post-transplantation anti-A titers or outcomes of A2 to B DDKTx since this allocation change.We conducted a retrospective, single center, cohort analysis of 29 consecutive A2 to B and 50 B to B DDKTx from December 2014 to December 2017. Pre- and postoperative anti-A titers were monitored prospectively. Outcomes included post-transplant anti-A titers, patient and graft survival, renal function, and hospital costs.African Americans comprised 72% of the A2 to B and 60% of the B to B group. There was no difference in mean wait time (58.8 vs 70.8 months). Paired tests indicated that anti-A IgG titers in A2 to B DDKTx were increased at discharge (p = 0.001) and at 4 weeks (p = 0.037). There were no significant differences in patient or graft survival, serum creatinine (SCr), or estimated glomerular filtration rate (eGFR), but the trajectories of SCr and eGFR differed between groups over the follow-up period. A2 to B had significantly higher mean transplant total hospital costs ($114,638 vs $91,697, p0.001) and hospital costs net organ acquisition costs ($42,356 vs $20,983, p0.001).Initial experience under KAS shows comparable outcomes for A2 to B vs B to B DDKTx. Anti-A titers increased significantly post-transplantation, but did not adversely affect outcomes. Hospital costs were significantly higher with A2 to B DDKTx. Transplant programs, regulators, and payors will need to weigh improved access for minorities with increased costs.

Patient-reported outcome (PRO) measures are often used to diagnose laryngopharyngeal reflux (LPR) and monitor treatment outcomes in clinical and research settings. The present systematic review was designed to identify currently available LPR-related PRO measures and to evaluate each measure's instrument development, validation, and applicability.MEDLINE via PubMed interface, CINAHL, and Health and Psychosocial Instrument databases were searched with relevant vocabulary and key terms related to PRO measures and LPR.Three investigators independently performed abstract review and full text review, applying a previously developed checklist to critically assess measurement properties of each study meeting inclusion criteria.Of 4947 studies reviewed, 7 LPR-related PRO measures (publication years, 1991-2010) met criteria for extraction and analysis. Two focused on globus and throat symptoms. Remaining measures were designed to assess LPR symptoms and monitor treatment outcomes in patients. None met all checklist criteria. Only 2 of 7 used patient input to devise item content, and 2 of 7 assessed responsiveness to change. Thematic deficiencies in current LPR-related measures are inadequately demonstrated: content validity, construct validity, plan for interpretation, and literacy level assessment.Laryngopharyngeal reflux is often diagnosed according to symptoms. Currently available LPR-related PRO measures used to symptomatically identify suspected LPR patients have disparate developmental rigor and important methodological deficiencies. Care should be exercised to understand the measurement characteristics and contextual relevance before applying these PRO measures for clinical, research, or quality initiatives.

Background Assessing incisional hernia recurrence typically requires a clinical encounter. We sought to determine if patient-reported outcomes (PROs) could detect long-term recurrence. Methods Adult patients 1 to 5 years after incisional hernia repair were prospectively asked about recurrence, bulge, and pain at the original repair site. Using dynamic abdominal sonography for hernia to detect recurrence, performance of each PRO was determined. Multivariable regression was used to evaluate PRO association with recurrence. Results Fifty-two patients enrolled with follow-up time 46 ± 13 months. A patient-reported bulge was 85% sensitive, and 81% specific to detect recurrence. Patients reporting no bulge and no pain had 0% chance of recurrence. In multivariable analysis, patients reporting a bulge were 18 times more likely to have a recurrence than those without (95% confidence interval, 3.7 to 90.0; P Conclusions This preliminary study demonstrates that PROs offer a promising means of detecting long-term recurrence after incisional hernia repair, which can help facilitate quality improvement and research efforts.

Background Single lung transplantation (SLT) and double lung transplantation (DLT) are associated with differences in morbidity and mortality, although the effects of transplant type on patient-reported outcomes are not widely reported and conclusions have differed. Previous studies compared mean health-related quality of life (HRQOL) scores but did not evaluate potentially different temporal trajectories in the context of longitudinal follow-up. To address this uncertainty, this study was designed to evaluate longitudinal HRQOL after SLT and DLT with the hypothesis that temporal trajectories differ between SLT and DLT. Methods Patients transplanted at a single institution were eligible to be surveyed at 1 month, 3 months, 6 months, and then annually after transplant using the Short Form 36 Health Survey, with longitudinal physical component summary (PCS) and mental component summary (MCS) scores as the primary outcomes. Multivariable mixed-effects models were used to evaluate the effects of transplant type and time posttransplant on longitudinal PCS and MCS after adjusting age, diagnosis, rejection, Lung Allocation Score quartile, and intubation duration. Time by transplant type interaction effects were used to test whether the temporal trajectories of HRQOL differ between SLT and DLT recipients. HRQOL scores were referenced to general population norms (range, 40 to 60; mean, 50 ± 10) using accepted standards for a minimally important difference (½ SD, 5 points). Results Postoperative surveys (n = 345) were analyzed for 136 patients (52% male, 23% SLT, age 52 ± 13 years, LAS 42 ± 12, follow-up 37 ± 29 months [range, 0.6 to 133]) who underwent lung transplantation between 2005 and 2016. After adjusting for model covariates, overall posttransplant PCS scores have a significant downward trajectory (p = 0.015) whereas MCS scores remain stable (p = 0.593), with both averaging within general population norms. The time by transplant type interaction effect (p = 0.002), however, indicate that posttransplant PCS scores of SLT recipients decline at a rate of 2.4 points per year over the total observation period compared to DLT. At approximately 60 months, the PCS scores of SLT recipients, but not DLT recipients, fall below general population norms. Conclusions The trajectory of physical HRQOL in patients receiving SLT declines over time compared with DLT, indicating that, in the longer term, SLT recipients are more likely to have physical HRQOL scores that fall substantively below general population norms. Physical HRQOL after 5 years may be a consideration for lung allocation and patient counseling regarding expectations when recommending SLT or DLT.

Some patients referred for kidney transplant evaluation fail to attend the visit. Our goal was to compare demographic, socioeconomic, and psychologic factors between evaluation visit attendees and absentees.A convenience sample of patients referred and scheduled for kidney transplant evaluation at a single center from November 2012 to December 2013 participated in a phone survey reporting socioeconomic, demographic, and clinical characteristics; health literacy; and perceived knowledge and concerns about transplantation. Absentees were matched by race with attendees. Analyses of differences between groups were performed with chi-square test, Fisher exact test, and t tests. Multivariable logistic regression was adjusted for relevant demographic characteristics.One hundred four adults participated (61% men, 46% white, 52 ± 12 years). Financial concerns were the most prevalent (67.3% affording medication, 64.1% affording operation). Previous evaluation at a different transplant center (P = 0.029) and being on dialysis (P = 0.008) were significantly associated with absence. Attendance was associated with concerns about finding a living donor (P = 0.038) and higher perceived general knowledge about transplantation (P ≤ 0.001). No differences were appreciated in demographic, socioeconomic, or health literacy factors between groups.Both attendee and absentee patients were most concerned with the financial burden of kidney transplantation. Although concerns and perceived knowledge are important correlates of behavior, other considerations such as psychologic factors and prior medical experiences may influence patients' ability to complete the kidney transplant evaluation process. Although this pilot study was conducted in a small sample and has limited generalizability, our findings can guide future research.

Variation exists in the management of choledocholithiasis (CDL). This study evaluated associations between demographic and practice-related characteristics and CDL management. A 22-item, web-based survey was administered to US general surgeons. Respondents were classified into metropolitan or nonmetropolitan groups by zip code. Univariate tests and multivariable logistic regression were used to determine factors associated with CDL management preferences. The survey was sent to 32,932 surgeons; 9902 performed laparoscopic cholecystectomy within the last year; 750 of 771 respondents had a valid US zip code and were included in the analysis. Mean practice time was 18 ± 10 years, 87 % were male, and 83 % practiced in a metropolitan area. For preoperatively known CDL, 86 % chose preoperative endoscopic retrograde cholangiopancreatography (ERCP). Those in metropolitan areas were more likely to select preoperative ERCP than those in nonmetropolitan areas (88 vs. 79 %, p

The United Network for Organ Sharing recently altered current liver allocation with the goal of decreasing Model for End-Stage Liver Disease (MELD) variance at transplant. Concerns over these and further planned revisions to policy include predicted decrease in total transplants, increased flying and logistical complexity, adverse impact on areas with poor quality health care, and minimal effect on high MELD donor service areas. To address these issues, we describe general approaches to equalize critical transplant metrics among regions and determine how they alter MELD variance at transplant and organ supply to underserved communities. We show an allocation system that increases minimum MELD for local allocation or preferentially directs organs into areas of need decreases MELD variance. Both models have minimal adverse effects on flying and total transplants, and do not disproportionately disadvantage already underserved communities. When combined together, these approaches decrease MELD variance by 28%, more than the recently adopted proposal. These models can be adapted for any measure of variance, can be combined with other proposals, and can be configured to automatically adjust to changes in disease incidence as is occurring with hepatitis C and nonalcoholic fatty liver disease.

Importance Patient-reported outcome (PRO) measures address the need for patient-centered data and are now used in diverse clinical, research, and policy pursuits. They are important in conditions causing upper airway–related dyspnea in which the patient’s reported experience and physiological data can be discrepant. Objectives To perform a systematic review of the literature on upper airway dyspnea–related PRO measures and to rigorously evaluate each measure’s developmental properties, validation, and applicability. Evidence Review This study strictly adhered to Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines. MEDLINE via the PubMed interface, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and the Health and Psychosocial Instruments (HaPI) database were searched using relevant vocabulary terms and key terms related to PRO measures and upper airway–related dyspnea. Three investigators performed abstract review, and 2 investigators independently performed full-text review by applying an established checklist to evaluate the conceptual model, content validity, reliability, construct validity, scoring and interpretability, and respondent burden and presentation of each identified instrument. The initial literature search was conducted in November 2014 and was updated in April 2016. Findings Of 1269 studies reviewed, 3 upper airway–related dyspnea PRO measures met criteria for inclusion. One PRO measure was designed de novo to assess upper airway–related dyspnea symptoms and monitor treatment outcomes, while 2 were adapted from established instruments designed for lower airway disease. Measurement properties and psychometric characteristics differed, and none met all checklist criteria. Two met a criterion in each of 7 domains evaluated. Two demonstrated test-retest and internal consistency reliability, and 2 showed that their scores were responsive to change. Thematic deficiencies in current upper airway–related dyspnea PRO measures are lack of patient involvement in item development (content validity), plan for interpretation, and literacy level assessments. Conclusions and Relevance PRO measures are critical in the assessment of patients with upper airway–related dyspnea. Three instruments with disparate developmental rigor have been designed or adapted to assess this construct. Care must be taken to understand the measurement characteristics and contextual relevance before applying these PRO measures for clinical, research, or quality initiatives.

IntroductionThe United States Department of Veterans Affairs (VA) National Transplant Program has made efforts to improve access by introducing Web-based referrals and telehealth. The aims of this study were to describe the programmatic implementation and evaluate the effectiveness of new technology on the timeliness to kidney transplant evaluation at a VA medical centre.MethodsBetween 1 January 2009 and 31 May 2016, 835 patients were approved for evaluation. Monthly data were summarized as: number of applications, median days to evaluation, and median percentage of evaluations that occurred within 30 days. Temporal trends were analysed using non-parametric comparisons of medians between three eras: Pre Web-based submission, Web-based submission, and Web-based submission with videoconference (VC) telehealth.ResultsThe number of applications did not vary between eras ( p = 0.353). The median time to evaluation and the median percentage of patients with appointments within 30 days improved significantly in the Web-based submission with VC era when compared with the Web-based and Pre Web-based eras (37 vs. 260 and 116 days, respectively, p DiscussionWe have been able to markedly improve the timeliness to kidney transplant waitlist evaluation with the addition of telehealth.

Current Model for End-Stage Liver Disease (MELD) exception points provided to patients with hepatocellular cancer (HCC) are not based on outcome data and advantage these patients compared to those listed based on laboratory values (LABMELD). We sought to develop a data-based assignment for exception points for patients with HCC that equalizes outcomes among HCC and LABMELD patients.We used Scientific Registry of Transplant Recipients data to compare patients listed with HCC who received exception points versus patients listed with LABMELD. Nation- and region-specific data were examined for (1) a composite outcome for adverse events of death, delisting, or becoming ineligible for transplant; and (2) transplant rate. We also determined MELD progression rates for LABMELD patients. Candidates listed with LABMELD scores were compared with those listed with 22 exception points for HCC (HCC22) to determine the LABMELD for which statistical parity was achieved for our composite outcome.HCC22 candidates time to adverse event were comparable to LABMELD scores of 16 (LABMELD16) candidates (range, 15-19), whereas time to transplant was comparable to LABMELD22 candidates (range, 21-23). LABMELD22 candidates had 2.1 times greater risk of adverse event compared with HCC22 (95% confidence interval, 1.9-2.4; range, 1.5-2.4). Progression among LABMELD16 candidates whose scores did not improve was similar across regions and averaged 0.94 points/month (95% confidence interval, 0.88-0.99, range 0.80-1.04).To equalize the occurrence of an adverse outcome, the proper listing MELD for patients with HCC is 16, with approximately 1 additional point/month. These results provide a data-driven algorithm to increase fairness in listing priority.

Background There are increasing numbers of patients undergoing orthotopic heart transplantation (OHT) with left ventricular assist device (LVAD) explantation (LVAD explant-OHT). We hypothesized that LVAD explant-OHT is a more challenging surgical procedure compared to OHT without LVAD explantation and that institutional LVAD explant-OHT procedural volume would be associated with post-transplant graft survival. We sought to assess the impact of institutional volume of LVAD explant-OHT on post-transplant graft survival. Methods This is a retrospective analysis of the Scientific Registry of Transplant Recipients for adult OHTs with long-term LVAD explantation. LVAD explant-OHT volume was characterized on the basis of the center's year-specific total OHT volume (OHTvol) and year-specific LVAD explant-OHT volume quartile (LVADvolQ). The effect of LVADvolQ on graft survival (death or re-transplantation) was analyzed. Results From 2004 to 2011, 2,681 patients underwent OHT with LVAD explantation (740 with HeartMate XVE, 1,877 with HeartMate II and 64 with HeartWare devices). LVAD explant-OHT at centers falling in the lowest LVADvolQ was associated with reduced post-transplant graft survival ( p = 0.022). After adjusting for annualized OHTvol (HR = 0.998, 95% CI 0.993 to 1.003, p = 0.515 and pulsatile XVE (HR = 0.842, 95% CI 0.688 to 1.032, p = 0.098), multivariate analysis confirmed a significantly (approximately 37%) increased risk of post-transplant graft failure among explant-OHT procedures occurring at centers in the lowest volume quartile (HR = 1.371, 95% CI 1.030 to 1.825, p = 0.030). Conclusion Graft survival is decreased when performed at centers falling in the lowest quartile of LVAD explant-OHT for a given year. This volume–survival relationship should be considered in the context of limited donor organ availability and the rapidly growing number of LVAD centers.

Background Health literacy (HL) may be a mediator for known socioeconomic and racial disparities in living kidney donation. Methods We evaluated the associations of patient and demographic characteristics with HL in living kidney donors (LD), living donor kidney transplant recipients (LDR), and deceased donor recipients (DDR) in a single-center retrospective review of patients undergoing kidney donation or transplantation from September 2010 to July 2012. HL and demographic data were collected. HL was assessed via the Short Literacy Survey (SLS) comprising three self-reported screening questions scored using the five-point Likert scale (low, moderate, high). Chi-square and logistic regression were used to test factors associated with lower HL. Results The sample included 360 adults (105 LD, 103 LDR, and 152 DDR; 46±14 years; 70% white; 56% male; 14±3 years of education). HL scores were skewed (49% high, 41% moderate, and 10% low). The distribution of HL categories differed significantly among groups (P=0.019). After controlling for age, race, sex, education, and a race-education interaction term, DDR was more likely to have moderate or low HL than LDR (OR, 1.911; 95% CI, 1.096-3.332; P=0.022). Conclusion Overall, living donors had high HL. The distribution of low, moderate, and high HL differed significantly between LD, DDR, and LDR. DDR had a higher likelihood of having low HL than LDR. Screening kidney transplant candidates and donors for lower HL may identify barriers to living donation. Future interventions addressing HL may be important to increase living donation and reduce disparities.

Objectives—We sought to determine: 1) if early weight regain between one and two years after RYGB is associated with worsened hepatic and peripheral insulin sensitivity, and 2) if preoperative levels of ghrelin and leptin are associated with early weight regain after RYGB. Design and Methods—Hepatic and peripheral insulin sensitivity and ghrelin and leptin plasma levels were assessed longitudinally in 45 subjects before RYGB and at one month, six months, one year, and two years post operatively. Weight regain was defined as ≥ 5% increase in body weight between one and two years after RYGB. Results—Weight regain occurred in 33% of subjects, with an average increase in body weight of 10 ± 5 % (8.5 ± 3.3 kg). Weight regain was not associated with worsening of peripheral or hepatic insulin sensitivity. Subjects with weight regain after RYGB had higher preoperative and postoperative levels of ghrelin compared to those who maintained or lost weight during this time. Conversely, the trajectories of leptin levels corresponded with the trajectories of fat mass in both groups. Conclusions—Early weight regain after RYGB is not associated with a reversal of improvements in insulin sensitivity. Higher preoperative ghrelin levels might identify patients that are more susceptible to weight regain after RYGB.

Background. Hepatitis C virus (HCV) cirrhosis is the leading indication for liver transplantation in the United States, although nonalcoholic steatohepatitis (NASH) is on the rise. Increasingly effective HCV antivirals are available, but their association with diagnosis-specific liver transplantation rates and early graft survival is not known. Methods. The Scientific Registry of Transplant Recipients database records were retrospectively stratified by HCV antiviral era: interferon (2003-2010), protease inhibitors (2011-2013), and direct-acting antivirals (2014 to present). Kaplan-Meier, χ2, and multivariable Cox proportional hazards regression models evaluated the effects of antiviral era and etiology of liver disease on transplantation rates and graft survival over 3 years. Results. Liver transplants for HCV decreased (35.3% to 23.6%), whereas those for NASH and alcoholic liver disease increased (5.8% to 16.5% and 15.6% to 24.0%) with each advancing era (all P < 0.05). Early graft survival improved with each advancing era for HCV but not for hepatitis B virus, NASH, or alcoholic liver disease (multivariable model era by diagnosis interaction P < 0.001). Era-specific multivariable models demonstrated that the risk of early graft loss for NASH was 22% lower than for HCV in the interferon era (hazard ratio, 0.78; 95% confidence interval, 0.64-0.96; P = 0.02) but risks associated with these diagnoses did not differ significantly in the protease inhibitor (P = 0.06) or direct-acting antiviral eras (P = 0.08). Conclusions. Increasing effectiveness of HCV antivirals corresponds with decreased rates of liver transplantation for HCV and improved early graft survival. As the rates of liver transplant for NASH continue to increase, focus will be needed on the prevention and effective therapies for this disease.

Background The reported effects of biliary injury on health‐related quality of life (HRQOL) have varied widely. Meta‐analysis methodology was applied to examine the collective findings of the long‐term effect of bile duct injury (BDI) on HRQOL. Methods A comprehensive literature search was conducted in March, 2012. Because the HRQOL surveys differed among reports, BDI and uncomplicated laparoscopic cholecystectomy (LC) groups' HRQOL scores were expressed as effect sizes (ES) in relation to a common, general population, standard. A negative ES indicated a reduced HRQOL, with a substantive reduction defined as an ES ≤ −0.50. Weighted logistic regression tested the effects of BDI (versus LC) and follow‐up time on whether physical and mental HRQOL were substantively reduced. Results Data were abstracted from six publications, which encompass all reports of HRQOL after BDI in the current, peer‐reviewed literature. The analytic database comprised 90 ES computations representing 831 patients and 11 unique study groups (six BDI and five LC). After controlling for follow‐up time ( P ≤ 0.001), BDI patients were more likely to have reduced long‐term mental [odds ratio (OR) = 38.42, 95% confidence interval (CI) = 19.14–77.10; P P = 0.993) HRQOL compared with LC patients. Discussion This meta‐analysis of findings from six peer‐review reports indicates that, in comparison to LC, there is a long‐term detrimental effect of BDI on mental HRQOL.

Objectives The aim of this study was to evaluate the cost‐effectiveness in liver transplantation (LT) of utilizing organs donated after cardiac death (DCD) compared with organs donated after brain death (DBD). Methods A Markov‐based decision analytic model was created to compare two LT waitlist strategies distinguished by organ type: (i) DBD organs only, and (ii) DBD and DCD organs. The model simulated outcomes for patients over 10 years with annual cycles through one of four health states: survival; ischaemic cholangiopathy; retransplantation, and death. Baseline values and ranges were determined from an extensive literature review. Sensitivity analyses tested model strength and parameter variability. Results Overall survival is decreased, and biliary complications and retransplantation are increased in recipients of DCD livers. Recipients of DBD livers gained 5.6 quality‐adjusted life years (QALYs) at a cost of US$69 000/QALY, whereas recipients on the DBD + DCD LT waitlist gained 6.0 QALYs at a cost of US$61 000/QALY. The DBD + DCD organ strategy was superior to the DBD organ‐only strategy. conclusions The extension of life and quality of life provided by DCD LT to patients on the waiting list who might otherwise not receive a liver transplant makes the continued use of DCD livers cost‐effective.

Most centers utilize phone or written surveys to screen candidates who self-refer to be living kidney donors. To increase efficiency and reduce resource utilization, we developed a web-based application to screen kidney donor candidates. The aim of this study was to evaluate the use of this web-based application. Method and time of referral were tabulated and descriptive statistics summarized demographic characteristics. Time series analyses evaluated use over time. Between January 1, 2011 and March 31, 2012, 1200 candidates self-referred to be living kidney donors at our center. Eight hundred one candidates (67%) completed the web-based survey and 399 (33%) completed a phone survey. Thirty-nine percent of donors accessed the application on nights and weekends. Postimplementation of the web-based application, there was a statistically significant increase (p < 0.001) in the number of self-referrals via the web-based application as opposed to telephone contact. Also, there was a significant increase (p = 0.025) in the total number of self-referrals post-implementation from 61 to 116 per month. An interactive web-based application is an effective strategy for the initial screening of donor candidates. The web-based application increased the ability to interface with donors, process them efficiently and ultimately increased donor self-referral at our center.

Background Although current national data show improved graft and patient survival following lung transplant, the effects of several modifiable preexisting comorbid conditions on health-related quality of life after transplant have not been evaluated. This study examines the effects of 3 comorbid conditions present before lung transplant (reduced bone density, diabetes mellitus, and elevated body mass index) on health-related quality of life after lung transplant. Methods The Short Form 36 Health Survey was completed by 92 adult recipients at various times after lung transplant (mean, 41 months; range, 1–127 months). Multiple linear regression models that controlled for underlying disease, chronic rejection, and time after transplant tested the independent effects of the 3 pretransplant conditions on posttransplant health-related quality of life. Results The effects of pretransplant reduced bone density and diabetes mellitus were not statistically significant in these models. However, pretransplant body mass index had a significant negative effect (β = −.29, P = .007) on posttransplant physical health–related quality of life. Additionally, overweight status and obesity exerted comparable independent negative effects ( P = .01 and P = .03, respectively) on the physical function scale of the Short-Form 36 Health Survey compared with persons who were underweight or normal weight before transplant. Conclusions Reevaluation of elevated body mass index before transplant as a risk for reduced physical quality of life after lung transplant should be considered.

Approximately 10000 deceased donor organs are available yearly for 85 000 US patients awaiting kidney transplant. Living kidney donation is essential to close this gap and offers better survival rates. However, nationally, 80% of potential donors evaluated fail to donate. Nurse coordinators who perform predonation screening and education need additional insight into the large number of potential donors who fail to complete the donation process. Reasons for nondonation in donor candidates undergoing medical evaluation, and variables affecting nondonation at Vanderbilt University Medical Center between 2004 and 2009 are examined. Multivariable logistic regression models are used to test the effects of age and race on donation status and reasons for nondonation. Summary data are frequencies, percentages, and means (SD). The sample included 706 candidates (63% female, 80% white; mean age, 40 [SD, 12] years). Almost half (46%) received clearance to donate. Undiagnosed hypertension (14%), abnormal glucose tolerance (10%), and proteinurea (9%) were the most prevalent medical reasons for nondonation. About 13% of candidates changed their minds during evaluation. Analyses demonstrated an increased likelihood of older candidates ( P < .001) and a decreased likelihood of white candidates ( P = .007) being excluded from donation. Within the nondonation group, increased age was associated with undiagnosed hypertension and abnormal glucose tolerance (both race-adjusted, P = .01). Younger candidates (race-adjusted, P = .003) and African Americans (age-adjusted, P = .04) were more likely to decide against donation. The most prevalent medical reasons for nondonation could be identified through enhanced prescreening, and improved preevaluation education could decrease nondonation rates.

Objective Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to (1) identify all currently available measures and (2) to evaluate each for the presence of important measurement properties that would affect their applicability. Design MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: (1) conceptual model, (2) content validity, (3) reliability, (4) construct validity, (6) scoring and interpretation, and (7) burden and presentation. Results Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987-2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinson's Disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: (1) direct patient involvement in content development, (2) empirically justified dimensionality, (3) demonstrable responsiveness to change, (4) plan for interpreting missing responses, and (5) literacy level assessment. Conclusion This is the first comprehensive systematic review assessing developmental properties of all available dysphagia-related PRO measures. We identified several instruments with robust measurement properties in multiple diseases including achalasia, oropharyngeal dysphagia, post-surgical dysphagia, esophageal cancer, and dysphagia related to neurological diseases. Findings herein can assist clinicians and researchers in making more informed decisions in selecting the most fundamentally sound PRO measure for a given clinical, research, or quality initiative.

Objective With improvements in medical management and survival of patients with end-stage renal disease, maintaining durable vascular access is increasingly challenging. This study compared primary, assisted primary, and secondary patency, and procedure-specific complications, and evaluated whether the number of interventions to maintain or restore patency differed between prosthetic femoral-femoral looped inguinal access (thigh) grafts and Hemodialysis Reliable Outflow (HeRO; Hemosphere Inc, Minneapolis, Minn) grafts. Methods A single-center, retrospective, intention-to-treat analysis was conducted of consecutive thigh and HeRO grafts placed between May 2004 and June 2015. Medical history, interventions to maintain or restore patency, and complications were abstracted from the electronic medical record. Data were analyzed using parametric and nonparametric statistical tests, Kaplan-Meier survival methods, and multivariable proportional hazards regression and logistic regression. Results Seventy-six (43 thigh, 33 HeRO) grafts were placed in 61 patients (54% male; age 53 [standard deviation, 13] years). Median follow-up time in the intention-to-treat analysis was 21.2 months (min, 0.0; max, 85.3 months) for thigh grafts and 6.7 months (min, 0.0; max, 56.3 months) for HeRO grafts ( P = .02). The groups were comparable for sex, age, coronary artery disease, diabetes mellitus, peripheral vascular disease, and smoking history (all P ≥ .12). One thigh graft (2%) and five HeRO (15%) grafts failed primarily. In the intention-to-treat analysis, patency durations were significantly longer in the thigh grafts (all log-rank P ≤ .01). Point estimates of primary patency at 6 months, 1 year, and 3 years were 61%, 46%, and 4% for the thigh grafts and 25%, 15%, and 6% for the HeRO grafts. Point estimates of assisted primary patency at 6 months, 1 year, and 3 years were 75%, 66%, and 54% for the thigh grafts and 41%, 30%, and 10% for the HeRO grafts. Point estimates of secondary patency at 6 months, 1 year, and 3 years were 88%, 88%, and 70% for the thigh grafts and 53%, 43%, and 12% for the HeRO grafts. There were no differences in ischemic ( P = .63) or infectious ( P = .79) complications between the groups. Multivariable logistic regression demonstrated that after adjusting for follow-up time, HeRO grafts were associated with an increased number of interventions ( P = .03). Conclusions Thigh grafts have significantly better primary, assisted primary, and secondary patency compared with HeRO grafts. There is no significant difference between thigh grafts and HeRO grafts in ischemic or infectious complications. Our logistic regression model demonstrated an association between HeRO grafts and an increased number of interventions to maintain or restore patency. Although HeRO grafts may extend the use of the upper extremity, thigh grafts provide a more durable option for chronic hemodialysis.

Controversy exists regarding the optimal timing of repair after iatrogenic bile duct injuries (BDI). Several studies advocate late repair (≥6 weeks after injury) with mandatory drainage and resolution of inflammation. Others indicate that early repair (6 weeks after injury) produces comparable or superior clinical outcomes. Additionally, although most studies have reported inferior outcomes with primary surgeon repair, this practice continues. With disparate published recommendations and rising health care costs, decision analysis was used to examine the cost-effectiveness of BDI repair.A Markov model was developed to evaluate primary surgeon repair (PSR), late repair by a hepatobiliary surgeon (LHBS), and early repair by a hepatobiliary surgeon (EHBS). Baseline values and ranges were collected from the literature. Sensitivity analsyses were conducted to test the strength of the model and variability of parameters.The model demonstrated that EHBS was associated with lower costs, earlier return to normal activity, and better quality of life. Specifically, 1 year after repair, PSR yielded 0.53 quality adjusted life years (QALYs) ($120,000/QALY) and LHBS yielded 0.74 QALYs ($74,000/QALY); EHBS yielded 0.82 QALYs ($48,000/QALY). Sensitivity analyses supported these findings at clinically meaningful probabilities.This cost-effectiveness model demonstrates that early repair by a hepatobiliary surgeon is the superior strategy for the treatment of BDI in properly selected patients. Although there is little clinical difference between early and late repair, there is a great difference in cost and quality of life. Ideally, costs and quality of life should be considered in decisions regarding strategies of repair of injured bile ducts.

The aim of this study was to identify race and socioeconomic factors associated with worse outcomes among Tennessee children who sustain firearm injuries.We queried our institutional pediatric trauma registry and the Davidson County Regional Medical Examiner database for children ages 15 years and younger who sustained firearm injuries between July 1998 and July 2010. Descriptive statistics and logistic regression modeling were used to analyze demographic data, circumstance of injury (unintentional or intentional), odds of death, and characteristics of zip codes (total population, race distribution, and median income) where injuries occurred.One hundred eighty-eight children (median age, 13.2 years; range, 1.1-15.8 years) sustained a firearm injury and were either admitted to our institution or were referred directly to the medical examiner. More whites (n = 109, or 58%) sustained a firearm injury than blacks (n = 79, or 42%), but blacks were overrepresented 2.5-fold more compared with the general Tennessee population. Fifty-four children (29%) died, of whom 35 (65%) were black and 19 (35%) were white (P.001). Ninety-three children sustained unintentional firearm injuries, and 84 were intentional (n = 67, assault; n = 17, suicide). When data were stratified by intent, 67% of blacks and 12% of whites were assaulted (P.001). After controlling for age and intent, black children were 4 times more likely to die of firearm injuries than whites (P = .008; 95% confidence interval, 1.4-11.3).In a sample of firearm-injured Tennessee children, blacks were notably overrepresented and far more likely to die than whites. Using zip code data will help to establish firearm injury prevention programs specific to disparate populations and to reduce both violent and accidental childhood firearm injuries.

OBJECTIVE Midbrain dopamine (DA) neurons, which are involved with reward and motivation, are modulated by hormones that regulate food intake (insulin, leptin, and acyl ghrelin [AG]). We hypothesized that these hormones are associated with deficits in DA signaling in obesity. RESEARCH DESIGN AND METHODS We assessed the relationships between fasting levels of insulin and leptin, and AG, BMI, and insulin sensitivity index (SI) with the availability of central DA type 2 receptor (D2R). We measured D2R availability using positron emission tomography and [18F]fallypride (radioligand that competes with endogenous DA) in lean (n = 8) and obese (n = 14) females. Fasting hormones were collected prior to scanning and SI was determined by modified oral glucose tolerance test. RESULTS Parametric image analyses revealed associations between each metabolic measure and D2R. The most extensive findings were negative associations of AG with clusters involving the striatum and inferior temporal cortices. Regional regression analyses also found extensive negative relationships between AG and D2R in the caudate, putamen, ventral striatum (VS), amygdala, and temporal lobes. SI was negatively associated with D2R in the VS, while insulin was not. In the caudate, BMI and leptin were positively associated with D2R availability. The direction of associations of leptin and AG with D2R availability are consistent with their opposite effects on DA levels (decreasing and increasing, respectively). After adjusting for BMI, AG maintained a significant relationship in the VS. We hypothesize that the increased D2R availability in obese subjects reflects relatively reduced DA levels competing with the radioligand. CONCLUSIONS Our findings provide evidence for an association between the neuroendocrine hormones and DA brain signaling in obese females.

OBJECTIVE Early after Roux-en-Y gastric bypass (RYGB), there is improvement in type 2 diabetes, which is characterized by insulin resistance. We determined the acute effects of RYGB, with and without omentectomy, on hepatic and peripheral insulin sensitivity. We also investigated whether preoperative diabetes or postoperative diabetes remission influenced tissue-specific insulin sensitivity after RYGB. RESEARCH DESIGN AND METHODS We studied 40 obese (BMI 48 ± 8 kg/m2) participants, 17 with diabetes. Participants were randomized to RYGB alone or in conjunction with omentectomy. Hyperinsulinemic-euglycemic clamps with isotopic-tracer infusion were completed at baseline and at 1 month postoperatively to assess insulin sensitivity. RESULTS Participants lost 11 ± 4% of body weight at 1 month after RYGB, without an improvement in peripheral insulin sensitivity; these outcomes were not affected by omentectomy, preoperative diabetes, or remission of diabetes. Hepatic glucose production (HGP) and the hepatic insulin sensitivity index improved in all subjects, irrespective of omentectomy (P ≤ 0.001). Participants with diabetes had higher baseline HGP values (P = 0.003) that improved to a greater extent after RYGB (P = 0.006). Of the 17 participants with diabetes, 10 (59%) had remission at 1 month. Diabetes remission had a group × time effect (P = 0.041) on HGP; those with diabetes remission had lower preoperative and postoperative HGP. CONCLUSIONS Peripheral insulin sensitivity did not improve 1 month after RYGB, irrespective of omentectomy, diabetes, or diabetes remission. Hepatic insulin sensitivity improved at 1 month after RYGB and was more pronounced in patients with diabetes. Improvement in HGP may influence diabetes remission early after RYGB.

hpb_355 783..791 Objective: The optimal strategy for treating hepatocellular carcinoma (HCC), a disease with increasing incidence, in patients with Child–Pugh class A cirrhosis has long been debated. This study evaluated the cost-effectiveness of hepatic resection (HR) or locoregional therapy (LRT) followed by salvage orthotopic liver transplantation (SOLT) vs. that of primary orthotopic liver transplantation (POLT) for HCC within the Milan Criteria. Methods: A Markov-based decision analytic model simulated outcomes, expressed in costs and quality-adjusted life years (QALYs), for the three treatment strategies. Baseline parameters were determined from a literature review. Sensitivity analyses tested model strength and parameter variability. Results: Both HR and LRT followed by SOLT were associated with earlier recurrence, decreased survival, increased costs and decreased quality of life (QoL), whereas POLT resulted in decreased recurrence, increased survival, decreased costs and increased QoL. Specifically, HR/SOLT yielded 3.1 QALYs (at US$96 000/QALY) and LRT/SOLT yielded 3.9 QALYs (at US$74 000/QALY), whereas POLT yielded 5.5 QALYs (at US$52 000/QALY). Sensitivity analyses supported these findings at clinically meaningful probabilities. Conclusions: Under the Model for End-stage Liver Disease (MELD) system, in patients with HCC within the Milan Criteria, POLT increases survival and QoL at decreased costs compared with HR or LRT followed by SOLT. Therefore, POLT is the most cost-effective strategy for the treatment of HCC.

Background: Diminished dopaminergic neurotransmission contributes to decreased reward and negative eating behaviors in obesity. Bariatric surgery is the most effective therapy for obesity and rapidly reduces hunger and improves satiety through unknown mechanisms. We hypothesized that dopaminergic neurotransmission would be enhanced after Roux-en-Y-Gastric Bypass (RYGB) and Vertical Sleeve Gastrectomy (VSG) surgery and that these changes would influence eating behaviors and contribute to the positive outcomes from bariatric surgery. Methods: Five females with obesity were studied preoperatively and at ∼ 7 weeks after RYGB or VSG surgery. Subjects underwent positron emission tomography (PET) imaging with a dopamine type 2 (DA D2) receptor radioligand whose binding is sensitive to competition with endogenous dopamine. Regions of interest (ROI) relevant to eating behaviors were delineated. Fasting enteroendocrine hormones were quantified at each time point. Results: Body weight decreased as expected after surgery. DA D2 receptor availability decreased after surgery. Regional decreases (mean ± SEM) were caudate 10 ± 3%, putamen 9 ± 4%, ventral striatum 8 ± 4%, hypothalamus 9 ± 3%, substantia nigra 10±2%, medial thalamus 8±2%, and amygdala 9 ± 3%. These were accompanied by significant decreases in plasma insulin (62%) and leptin (41%). Conclusion: The decreases in DA D2 receptor availability after RYGB and VSG most likely reflect increases in extracellular dopamine levels. Enhanced dopaminergic neurotransmission may contribute to improved eating behavior (e.g. reduced hunger and improved satiety) following these bariatric procedures.

Lack of health insurance is associated with poorer outcomes for patients with cancers amenable to early detection. The effect of insurance status on hepatocellular carcinoma (HCC) presentation stage and treatment outcomes has not been examined. We examined the effect of health insurance status on stage of presentation, treatment strategies, and survival in patients with HCC. The Tennessee Cancer Registry was queried for patients treated for HCC between January 2004 and December 2006. Patients were stratified by insurance status: (1) private insurance; (2) government insurance (non-Medicaid); (3) Medicaid; (4) uninsured. Logistic, Kaplan–Meier, and Cox models tested the effects of demographic and clinical covariates on the likelihood of having surgical or chemotherapeutic treatments and survival. We identified 680 patients (208 private, 356 government, 75 Medicaid, 41 uninsured). Uninsured patients were more likely to be men, African American, and reside in an urban area (all P

BACKGROUND The United Network for Organ Sharing system allocates deceased donor kidneys based on the kidney donor profile index (KDPI), stratified as sequences (A ≤ 20%, B > 20- 85%), with increasing KDPI associated with decreased graft survival. While health-related quality of life (HRQOL) may improve after transplantation, the effect of donor kidney quality, reflected by KDPI sequence, on post-transplant HRQOL has not been reported. METHODS Health-related quality of life was measured using the eight scales and physical and mental component summaries (PCS, MCS) of the SF-36® Health Survey. Multivariable mixed effects models that adjusted for age, gender, rejection, and previous transplant and analysis of variance methods tested the effects of time and KDPI sequence on post-transplant HRQOL. RESULTS A total of 141 waitlisted adults and 505 recipients (>1700 observations) were included. Pretransplant PCS and MCS averaged, respectively, slightly below and within general population norms (GPN; 40-60). At 31 ± 26 months post-transplant, average PCS (41 ± 11) and MCS (51 ± 11), overall and within each KDPI sequence, were within GPN. KDPI sequence was not related to post-transplant HRQOL (P > .134) or its trajectory (interaction P > .163). CONCLUSION Increasing KDPI does not adversely affect the medium-term values and trajectories of HRQOL after kidney transplantation. This may reassure patients and centers when considering using high KDPI kidneys.

Background Recent studies demonstrate that obesity does not affect survival after kidney transplantation. However, overweight and obesity impair health-related quality of life (HRQOL) in patients with chronic illnesses. We wished to examine the effects of pre-transplant overweight and obesity on post-transplant physical HRQOL in kidney transplant recipients. Study Design Patient-reported HRQOL data were systematically collected in kidney transplant recipients receiving post-transplant follow-up at Vanderbilt Transplant Center. Patients who received kidney transplants between 1998 and 2008, had at least 1 post-transplant physical component summary (PCS) measurement, and did not receive other solid organ transplants were included in this retrospective cohort study. Pre-transplant body mass index was stratified as normal, overweight, obese class I, and obese class II/extremely obese. HRQOL was measured primarily with the PCS scale of the Medical Outcomes Study Short Form 36 Health Survey. Multivariate linear and logistic regression models were used to test the effects of body mass index and demographic and clinical covariates on post-transplant HRQOL. Results The study cohort included 464 adults (mean body mass index 27.5 ± 5.1; range 18.5 to 47.4). After controlling for gender (p = 0.148), pre-transplant dialysis (p = 0.003), previous kidney transplantation (p = 0.255), donor type (p = 0.455), steroid avoidance immunosuppression (p = 0.070), and follow-up time (p = 0.352), there was no effect of pre-transplant overweight or obesity on post-transplant PCS (all p ≥ 0.112). Kidney transplant recipients who did not require dialysis pre-transplant and those who were managed with steroid avoidance after transplantation were more likely to achieve post-transplant PCS scores at or above the general population average (both p ≤ 0.011). Conclusions Pre-transplant overweight and obesity do not affect physical quality of life after kidney transplantation.

Background Obesity and type 2 diabetes are associated with renal dysfunction, which improves after Roux-en-Y gastric bypass (RYGB). During a 12-month follow-up period, we studied prospectively the changes in glomerular and tubular functions that occurred in excessively obese diabetic and non diabetic subjects after RYGB. Methods The cohort included 35 patients, 54% of whom had type 2 diabetes. Glomerular filtration rate (GFR) was estimated using creatinine clearance. Tubular function was studied by measuring the ratio of urinary cystatin C to urinary creatinine (UCC ratio). Results Baseline renal parameters, anthropometric characteristics, and changes in body mass index after the surgical procedures were similar between the 2 cohorts. At 12 months after RYGB, creatinine clearance decreased 15% in diabetics ( P = .02) and 21% in nondiabetics ( P = .03). A change in GFR was seen earlier in the nondiabetics (–29% after 6 months; P = .003). The UCC ratio was increased at both 6- and 12-month follow-ups ( P = .03 and .003, respectively) only in the diabetic group. Conclusion GFR was improved at 12 months after RYGB, with nondiabetics showing a greater propensity score. Tubular function remained unchanged in the nondiabetic subjects, but worsening occurred in the diabetic subjects. These results underscore the importance of reversal of excessive obesity before the onset of frank diabetes.

Social validation is the value judgment from society on the importance of a study. The social validity of behavior goals used in the social competence intervention literature was assessed using the Q-sort technique. The stimulus items were 80 different social competence behavior goals taken from 78 classroom-based social competence intervention studies published between 1970 and 2000 for preschool children. Participants ( N = 36) were early childhood special educators, early childhood educators, and administrators. Participants generated three distinct viewpoints concerning valued social competence behavior goals: Factor 1, reduction in negative behaviors; Factor 2, pro-social; and Factor 3, communication and good manners. Recommendations for research in the area of social competence interventions are discussed in light of these findings.