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Background: This study sought to identify factors that contribute to disparities in access to bariatric surgery in North Carolina (NC)., Methods: Using the rate of bariatric surgery in the county with the best health outcome as the reference, we calculated the Surgical Equity Index (SEI) in the remaining counties in NC., Results: Approximately 2.95 million individuals (29%) were obese in NC. There were 992 (.5%) bariatric procedures performed on a population of 194 209 individuals with obesity in the Reference County (RC). The mean SEI for bariatric surgery in NC was .47 (SD .17, range .15-.95). A statistically significant difference was observed in 89 counties. Univariable analyses identified the following variables to be significantly associated with the SEI: percent of population living in rural areas (% rural) (relative rate change in SEI [RR] = .994, 95% CI .92-.997; <.0001), median household income (RR = 1.0, 95% CI = 1.0-1.0; P = .0002), prevalence of diabetes (RR = .947, 95% CI .917-.977; .0006), the primary care physician ratio (RR = .995, 95% CI .991-.998; P = .006), and percent uninsured adults (RR = .955, 95% CI .927-.985; P = .003). By multivariable hierarchical regression analysis, only the % rural remained statistically associated with a low SEI (RR = .995 per 1% increase in % rural, 95% CI = .992, .998; P = .0002)., Discussion: The percent rural is the most significant predictor of disparities in access to bariatric surgery. For every 1% increase in % rural, the rate of surgery decreased by .5%. Understanding the characteristics of rurality that are barriers to access is crucial to mitigate disparities in bariatric surgical access in NC., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Introduction: Reducing disparities in colorectal cancer (CRC) screening rates and mortality remains a priority. Mitigation strategies to reduce these disparities have largely been unsuccessful. The primary aim is to determine variables in models of healthcare utilization and their association with CRC screening and mortality in North Carolina., Methods: A cross-sectional analysis of publicly available data across North Carolina using variable reduction techniques with clustering to evaluate association of CRC screening rates and mortality was performed., Results: Three million sixty-five thousand five hundred thirty-seven residents (32.1%) were aged 50 y or more. More than two-thirds (68.8%) were White, while 20.5% were Black. Approximately 61% aged 50 y or more underwent CRC screening (range: 44.0%-80.5%) and had a CRC mortality of 44.8 per 100,000 (range 22.8 to 76.6 per 100,000). Cluster analysis identified two factors, designated social economic education index (factor 1) and rural provider index (factor 2) for inclusion in the multivariate analysis. CRC screening rates were associated with factor 1, consisting of socioeconomic and education variables, and factor 2, comprised of the number of providers per 10,000 individuals aged 50 y or more and rurality. An increase in both factors 1 and 2 by one point would result in an increase in CRC screening rated by 6.8%. CRC mortality was associated with factor 2. An increase in one point in factor 1 results in a decrease in mortality risk by 10.9%., Conclusions: In North Carolina, using variable reduction with clustering, CRC screening rates were associated with the inter-relationship of the number of providers and rurality, while CRC mortality was associated with the inter-relationship of social, economic, and education variables., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Introduction: Despite advances in colorectal cancer (CRC) treatment, racial disparities persist. The primary aims of the study were to: evaluate differences in molecular testing rates over time by race; and measure the incidence of tumor mutations by race in patients with metastatic CRC., Methods: A retrospective cohort study was performed of all adult patients with stage IV CRC (2008-2018) identified within the cancer registry of a large regional health system. Demographic/clinical characteristics were collected through primary data abstraction of the electronic health record. Molecular profiling results were obtained directly from Caris Molecular Intelligence and electronic health record., Results: Three hundred eighty-three patients were included: 40.5% (n = 155) were Black and 59.5% (n = 228) were White. Significant increases were observed in microsatellite instability (MSI), KRAS, and BRAF testing rates during the study period (P < 0.0001). The odds of testing over time increased more significantly in Black compared to White patients for MSI testing (White: odds ratio [OR] 1.26 [95% confidence interval [CI] 1.12-1.41], Black: OR 1.69 [95% CI 1.41-2.02], P = 0.005) and BRAF testing (White: OR 1.42 [95% CI 1.26-1.62], Black: OR 1.89 [95% CI 1.51-2.36], P = 0.027). An increase in KRAS testing over time was observed for both cohorts and was independent of race (P = 0.58). Mutation rates did not differ by race: KRAS (Black 55.8% versus White 45.6%, P = 0.13) and BRAF (Black 4.8% versus White 10.0%, P = 0.33)., Conclusions: Within a large regional health system, molecular testing rates in patients with metastatic CRC increased significantly following National Comprehensive Cancer Network guideline changes for both Black and White patients. Black and White patients who underwent molecular testing had similar rates of MSI, KRAS, and BRAF mutations., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objectives: There is a perception, with mixed literary support, that patients are transferred from community hospitals to tertiary medical centers for non-clinical reasons (ie, payor, race, and admission time). Over-triage risks unequally burdening the tertiary medical centers within a trauma system. This study aims to identify potential non-clinical factors associated with the transfer of injured patients., Methods: Using the 2018 North Carolina State Inpatient Database, patients with a primary diagnosis of spine, rib or extremity fractures, or TBI were identified using ICD-10-CM code and admission type of "Urgent," "Emergency," or "Trauma." Patients were divided into cohorts of "retained" (at community hospital) or "transferred" (Level-1 or 2 trauma centers)., Results: 11,095 patients met inclusion criteria; 2432 (21.9%) patients made up the transfer cohort. The mean ISS for all retained patients was 2.2 (±.9) and 2.9 (±1.4) for all transferred patients. The transfer cohort was younger (mean age 66 v 75.8), underinsured, and more likely to be admitted after 1700 ( P < .001). Similar differences were seen regardless of injury pattern., Conclusions: Patients transferred to trauma centers were more likely to be underinsured and be admitted outside of normal business hours. These transferred patients had longer lengths of stay and higher mortality rates. Across all cohorts, similar ISS suggests that a portion of the transfers could be managed at a community hospital. After hours transfers suggest a need for more robust community hospital coverage. Intentional triage of the injured patient encourages appropriate utilization of resources and is crucial to maintaining high-functioning trauma centers and systems., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Purpose: To identify predictors of screening mammography use and the effect of screening mammography on breast cancer mortality in North Carolina., Methods: This cross-sectional study integrated publicly available data from government and private data repositories to model predictors of screening mammography and breast cancer mortality in North Carolina., Results: In North Carolina during 2008-2010, on average, 68.1% of women aged 40-74 years underwent a screening mammogram in the previous two years (range: 38.7%-82.1). The ordinary least squares (OLS) regression demonstrated counties experiencing persistent poverty have mammography screening rates that are 4.3% less, on average, than counties without persistent poverty (estimate (SE) = - 4.283 (2.105), p = 0.045). As the percentage of women with a college education increases, the mammography screening rates increase by approximately 0.3% (estimate (SE) = 0.319 (0.078), P < .001) and as the health literacy score increases, the mammography screening rate decreases by 0.3% (estimate (SE) = - 0.318 (0.104), p = 0.003). These variables explain 7.0% of the variability in mammographic screening rates. The OLS regression analysis demonstrated that age-adjusted breast cancer incidence (Estimate (SE) = 0.074 (0.024), p = 0.003) and health literacy score (estimate (SE) = - 0.175 (0.083), p = 0.039) are significantly related to breast cancer mortality., Conclusions: Demographic, socioeconomic, and environmental variables explain only a small percentage of the variability in the rates of screening mammography and breast cancer mortality in North Carolina. Advances in the available treatments are likely the major contributor to improving breast cancer mortality., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: Disparities in access to surgical care are associated with poorer outcomes in patients with cancer. We sought to determine whether vulnerable populations undergo an expected rate of surgery for Stage I-IIIA lung cancer in North Carolina (NC)., Methods: We calculated the proportional surgical ratio (PSR) to identify a potential disparity in surgery rates for early stage (I-IIIA) lung cancer, first in the five counties with the worst health outcomes (LRC) and subsequently the entire state. The reference was the five healthiest counties (HRC), initially, and then the single county with the best health outcomes., Results: In 2016, 3,452 individuals with Stage I-IIIA lung cancer were diagnosed in NC of which 246,854 resided in LRC, whereas 1,865,588 resided in HRC. A total of 453 operable lung cancers were diagnosed in the HRC and 107 in the LRC. The observed lobectomy rate in HRC was 40.1% (range 20.2-58.3%) of early-stage lung cancer and 19% (range 12-36%) for LRC. The PSR was 0.65 (95% confidence interval [CI] = 0.35, 0.90). For all 99 counties across NC, the PSR ranged from 0.33 to 0.96 (mean = 0.49, standard deviation [SD] = 0.10). In a multivariable model, only other primary care provider ratio (relative rate per 100 increase = 0.997; 95% CI = 0.994, 0.999) was significantly associated with PSR., Conclusions: Individuals residing in LRC in NC are 42% less likely to undergo surgery for operable lung cancer than patients living in HRC. Understanding how factors impact access is key to designing informed interventions., (© 2022. Society of Surgical Oncology.)

Background: The 2010 Patient Protection and Affordable Care Act mandated preventive screening coverage and provided support to participating states for Medicaid coverage. The association of Medicaid expansion with colon cancer stage at diagnosis is unknown., Objective: This study aimed to determine whether the proportion of patients diagnosed with early stage colon cancer changed over time within states that expanded Medicaid compared with nonexpansion states., Design: This is a cross-sectional cohort study., Setting: This study evaluated multicenter registry data from the National Cancer Database (2006-2016)., Patients: There were 25,462 uninsured or Medicaid-insured patients with newly diagnosed colon cancer who resided in 2014 Medicaid expansion or nonexpansion states., Main Outcome Measures: This study assessed the annual proportion of patients with early stage (I-II) versus late stage (III-IV) colon cancer., Results: A total of 10,289 patients were identified in expansion states and 15,173 patients in nonexpansion states. Cohorts were similar in age (median 55 years) and sex (46.7% female). A greater proportion of patients in nonexpansion states were Black (33.4% vs 24.0%) and resided in a zip code with median income <$38,000 (39.7% vs 28.2%) and lower educational status (37.4% vs 28.1%). In 2006, the proportions of patients with early stage colon cancer in expansion and nonexpansion cohorts were similar (33.2% vs 32.5%). The proportion of patients with early stage colon cancer within nonexpansion states declined by 0.8% per year after 2014, whereas the proportion within expansion states increased by 0.9% per year after 2014 ( p < 0.05). By 2016, the absolute difference in the propensity-adjusted proportion of early stage colon cancer was 8.8% (39.7% vs 30.9%, p < 0.001)., Limitations: National Cancer Database data are obtained only from Commission on Cancer-accredited sites and are not population based., Conclusions: After Medicaid expansion in 2014, the proportion of patients diagnosed and treated at Commission on Cancer-accredited facilities with early stage colon cancer increased within expansion states and decreased in nonexpansion states. Increase in insurance coverage may have facilitated earlier diagnosis among patients in expansion states. See Video Abstract at http://links.lww.com/DCR/B804 ., Cambios En La Proporcin De Pacientes Que Presentan Cncer De Colon En Estadio Temprana a Lo Largo Del Tiempo Entre Los Estados De Expansin Y No Expansin De Medicaid Un Estudio Transversal: ANTECEDENTES:La Ley del Cuidado de Salud a Bajo Precio del 2010 ordenó la cobertura de exámenes preventivos y brindó apoyo a los estados participantes para la cobertura de Medicaid. Se desconoce la asociación de la expansión de Medicaid con el estadio del cáncer de colon en el momento del diagnóstico.OBJETIVO:Determinar si la proporción de pacientes diagnosticados con cáncer de colon en estadio temprano cambió con el tiempo dentro de los estados que expandieron Medicaid en comparación con los estados sin expansión.DISEÑO:Estudio de cohorte transversal.ENTORNO CLINICO:Datos de registro multicéntrico de la Base de datos nacional de cáncer (2006-2016).PACIENTES:Había 25,462 pacientes sin seguro o asegurados por Medicaid con cáncer de colon recién diagnosticado. Exposición: Residencia en estados de expansión o no expansión de Medicaid en el 2014.PRINCIPALES MEDIDAS DE RESULTADO:Proporción anual de pacientes con cáncer de colon en estadio temprano (I-II) versus tardío (III-IV).RESULTADOS:Se identificaron un total de 10.289 pacientes en estados de expansión y 15.173 pacientes en estados de no expansión. Las cohortes fueron similares en edad (mediana de 55 años) y sexo (46,7% mujeres). Una mayor proporción de pacientes en estados sin expansión eran de raza negra (33,4% vs 24,0%) y residían en un código postal con ingresos medios <$38 000 (39,7% vs 28,2%) y un nivel educativo más bajo (37,4% vs 28,1%). En el 2006, las proporciones de pacientes con cáncer de colon en estadio temprano en cohortes en expansión y sin expansión fueron similares (33,2% vs 32,5%). La proporción de pacientes con estadio temprano dentro de los estados sin expansión disminuyó en un 0,8% por año después del 2014, mientras que la proporción dentro de los estados de expansión aumentó en un 0,9% por año después del 2014 (p <0,05). Para el 2016, la diferencia absoluta en la proporción ajustada por propensión de cáncer de colon en estadio temprano fue de 8.8% (39.7% vs 30.9%, p <0.001).LIMITACIONES:Los datos de la Base de datos nacional de cáncer se obtienen únicamente de los sitios acreditados por la Comisión de cáncer y no se basan en la población.CONCLUSIONES:Después de la expansión de Medicaid en el 2014, la proporción de pacientes diagnosticados y tratados en instalaciones acreditadas por la Comisión de Cáncer en pacientes con cáncer de colon en estadio temprano aumentó dentro de los estados de expansión y disminuyó en los estados de no expansión. El aumento de la cobertura del seguro puede haber facilitado un diagnóstico más temprano entre los pacientes en estados de expansión. Consulte Video Resumen en http://links.lww.com/DCR/B804 . (Traducción- Dr. Francisco M. Abarca-Rendon )., (Copyright © The ASCRS 2021.)

Background: NIH-established indications for bariatric surgery were set close to 3 decades ago., Objectives: The purpose of this study was to evaluate outcomes in patients undergoing bariatric surgery with class I obesity, a class that does not fall into current indications., Setting: University Hospital., Methods: De-identified records from a clinic system's Electronic Health Record database were accessed to identify adult patients undergoing Roux-en-Y gastric bypass (RYGB) (n = 566) and sleeve gastrectomy (SG) (n = 730). Patients were compared in terms of resolution of co-morbidities and weight loss outcomes at 3 years following surgery. A mixed effects model was used, adjusting for the type of surgery, the number of quarters after the surgery when the averaged measurements were taken, and the interaction between these two variables., Results: Patients lost up to 20% of their initial body mass index (BMI). Being of younger age, female, and having an obesity-related co-morbidity were associated with greater weight loss. At around 2 years after the surgery, the likelihood of being in remission from type 2 diabetes reached 45%. Remission probabilities for hypertension are 60% for RYGB and 50% for SG, 3 years after the surgery. On the other hand, the probabilities of remission from hyperlipidemia are close to 50% and 25% for RYGB and SG at 2 years. There was no difference between the BMI trajectories and remission from type 2 diabetes (T2D) when comparing the 2 groups., Conclusions: Bariatric surgery is effective in weight loss and resolution of comorbidities in patients with class I obesity. This data further supports the need to revisit the current indication criteria., (Copyright © 2022 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Bariatric surgery has shown an improvement in obesity and obesity-related disease in many clinical trials and single center studies. However, real-world data, including data from non-centers of excellence, is sparse., Objectives: To provide clinical outcomes of patients who underwent bariatric surgery in real-world clinical setting., Setting: Academic Institution., Methods: Adults with obesity undergoing Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and a control group (CG) between 2007 and 2019 were identified. The CG represented patients with a previous visit to a bariatric surgeon without a subsequent surgery. Cohorts were matched on age, gender, ethnicity, baseline body mass index (BMI), and presence of diabetes and hypertension. Groups were compared in terms of co-morbidities, weight loss, and chronic conditions for three years., Results: A total of 61 313 patients were identified. From these, 14 916 RYGB and 20 867 SG patients were matched to the CG (n = 16 562). The median BMI loss three years after surgery was 28.7% (interquartile range [IQR] 20.8%-36.2%) and 20.5% (IQR 13.5%-28.6%) for RYGB and SG groups, respectively. The CG had a median BMI loss of 6.7% with IQR of 20.4% decrease to 1.78% gain. At three years postoperatively, HbA1C decreased by 13% for RYGB and 5.9% for the SG group. The probabilities of remission from diabetes, hypertension, and low high-density lipoprotein cholesterol were significantly higher among patients who had surgery compared to the CG. For both RYGB and SG, the estimated probabilities of remission were similar., Conclusion: This study shows that bariatric surgery performed in the real-world clinical setting is an effective therapy for various expressions of the metabolic syndrome with results that are comparable to randomized control trials., (Copyright © 2021 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Importance: Although optimal access is accepted as the key to quality care, an accepted methodology to ascertain potential disparities in surgical access has not been defined., Objective: To develop a systematic approach to detect surgical access disparities., Design, Setting, and Participants: This cross-sectional study used publicly available data from the Health Cost and Utilization Project State Inpatient Database from 2016. Using the surgical rate observed in the 5 highest-ranked counties (HRCs), the expected surgical rate in the 5 lowest-ranked counties (LRCs) in North Carolina were calculated. Patients 18 years and older who underwent an inpatient general surgery procedure and patients who underwent emergency inpatient cholecystectomy, herniorrhaphy, or bariatric surgery in 2016 were included. Data were collected from January to December 2016, and data were analyzed from March to July 2020., Exposures: Health outcome county rank as defined by the Robert Wood Johnson Foundation., Main Outcomes and Measures: The primary outcome was the proportional surgical ratio (PSR), which was the disparity in surgical access defined as the observed number of surgical procedures in the 5 LRCs relative to the expected number of procedures using the 5 HRCs as the standardized reference population., Results: In 2016, approximately 1.9 million adults lived in the 5 HRCs, while approximately 246 854 lived in the 5 LRCs. A total of 28 924 inpatient general surgical procedures were performed, with 4521 being performed in those living in the 5 LRCs and 24 403 in those living in the 5 HRCs. The rate of general surgery in the 5 HRCs was 13.09 procedures per 1000 population. Using the 5 HRCs as the reference, the PSR for the 5 LRCs was 1.40 (95% CI, 1.35-1.44). For emergent/urgent cholecystectomy, the PSR for the 5 LRCs was 2.26 (95% CI, 2.02-2.51), and the PSR for emergent/urgent herniorrhaphy was 1.83 (95% CI, 1.33-2.45). Age-adjusted rate of obesity (body mass index [calculated as weight in kilograms divided by height in meters squared] greater than 30), on average, was 36.6% (SD, 3.4) in the 5 LRCs vs 25.4% (SD, 4.6) in the 5 HRCs (P = .002). The rate of bariatric surgery in the 5 HRCs was 33.07 per 10 000 population with obesity. For the 5 LRCs, the PSR was 0.60 (95% CI, 0.51-0.69)., Conclusions and Relevance: The PSR is a systematic approach to define potential disparities in surgical access and should be useful for identifying, investigating, and monitoring interventions intended to mitigate disparities in surgical access that effects the health of vulnerable populations.

Introduction: It was hypothesized that patients experiencing at least one tacrolimus formulation switch may require more frequent therapeutic drug monitoring, subsequent dose adjustments, and a potential for untoward clinical outcomes than patients who remain on a single formulation., Methods: Eligible patients were adult kidney transplant recipients with stable renal function at month 3 post-transplant and no evidence of acute rejection, receiving an oral, tacrolimus-based regimen. Patients were categorized into two groups (fixed or variable formulation) using the US National Drug Code (NDC) on the basis of tacrolimus formulation usage over the 12-month period., Results: A total of 305 patients were enrolled from four US transplant centers; 44 (14.4%) received multiple formulations and 261 (85.6%) received a single formulation. Mean number of tacrolimus dose adjustments and mean cumulative milligram dose change were not statistically different between the two groups. Mean trough-to-dose ratio, frequency of trough level measurements, and mean number of excursions above 120% or below 80% of the patient's mean trough concentration were significantly higher in the variable compared to the fixed formulation group., Conclusion: A variable tacrolimus formulation regimen was associated with a higher frequency of trough level measurements and a greater number of excursions in trough levels compared with continuing on a fixed formulation regimen of tacrolimus in this retrospective chart review study., Funding: Astellas Pharma Global Development, Inc. Plain language summary available for this article.

The proportion of heart transplant recipients bridged with durable, intracorporeal left ventricular assist devices (dLVADs) has dramatically increased; however, concern exists regarding obligate repeat sternotomy, increased bleeding risk because of anticoagulation and acquired von Willebrand disease, and increased rates of allosensitization. Whether dLVAD patients have impaired posttransplant outcomes compared with equivalent patients with less invasive intraaortic balloon pump counterpulsation (IABP) at the time of transplant is unknown. Therefore, we analyzed adult, first time, heart-only transplant procedures with dLVAD (n = 2,636) compared with IABP (n = 571) at the time of transplant based on data from the United Network for Organ Sharing (UNOS) July 2004 to December 2011. There was clear geographic variation in IABP and dLVAD at transplant. Multivariable analysis demonstrated equivalent cumulative risk of death (adjusted Cox proportional hazard ratio, 1.08; 95% confidence interval, 0.87-1.33; p = 0.51). There was no significant difference in adjusted comparison of perioperative morality, length of stay, postoperative renal failure requiring dialysis, or early acute rejection (p ≥ 0.14 for all). Therefore, data from UNOS suggest that the presence of dLVAD at the time of heart transplantation does not have a detrimental effect on postoperative outcomes compared with IABP, which must be considered in the context of pretransplant mortality and locoregional organ availability.

Background: Previous studies demonstrate that graft survival from older living kidney donors (LD; age>60 years) is worse than younger LD but similar to deceased standard criteria donors (SCD). Limited sample size has precluded more detailed analyses of transplants from older LD., Methods: Using the United Network for Organ Sharing database from 1994 to 2012, recipients were categorized by donor status: SCD, expanded criteria donor (ECD), or LD (by donor age: <60, 60-64, 65-69, ≥70 years). Adjusted models, controlling for donor and recipient risk factors, evaluated graft and recipient survivals., Results: Of 250,827 kidney transplants during the study period, 92,646 were LD kidneys, with 4.5% of these recipients (n=4,186) transplanted with older LD kidneys. The use of LD donors 60 years or older increased significantly from 3.6% in 1994 to 7.4% in 2011. Transplant recipients with older LD kidneys had significantly lower graft and overall survival compared to younger LD recipients. Compared to SCD recipients, graft survival was decreased in recipients with LD 70 years or older, but overall survival was similar. Older LD kidney recipients had better graft and overall survival than ECD recipients., Conclusions: As use of older kidney donors increases, overall survival among kidney transplant recipients from older living donors was similar to or better than SCD recipients, better than ECD recipients, but worse than younger LD recipients. With increasing kidney donation from older adults to alleviate profound organ shortages, the use of older kidney donors appears to be an equivalent or beneficial alternative to awaiting deceased donor kidneys.

Recurrent hepatitis C virus (HCV) remains a problematic cause of morbidity and mortality for liver transplant patients. Immunosuppression including calcineurin-inhibitors has been implicated in the acceleration of recurrent HCV. Recent studies suggest that outcomes may be better with cyclosporine (CSA-ME) compared to tacrolimus (TAC), but the data are inconclusive. We retrospectively analyzed data received from the United Network for Organ Sharing on 8809 chronic HCV liver transplant recipients receiving either cyclosporine microemulsion (CSA-ME) or tacrolimus (TAC) as maintenance immunosuppression prior to discharge. We analyzed patient death, graft failure, failure due recurrent disease and acute cellular rejection (ACR) for CSA-ME versus TAC treated patients. Three-year unadjusted patient and graft survival rates were 76.8% and 71.5%, respectively, in the CSA-ME group versus 79.9% and 75.0% in the TAC group. Propensity score-adjusted results suggest CSA-ME treated patients are at increased risk of patient death and graft failure [Hazards ratio (HR) = 1.17; 95% CI = 1.01-1.36 and HR = 1.19; 95% CI = 1.04-1.35, respectively] and biopsy-confirmed AR (HR = 2.03; 95% CI = 1.54-2.67) compared to TAC treated patients. These results provide evidence to reconsider the targeted administration of CSA-ME to HCV-infected liver transplant recipients., (©2011 The Authors Journal compilation©2011 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Delayed graft function (DGF) impacts short- and long-term outcomes. We present a model for predicting DGF after renal transplantation. A multivariable logistic regression analysis of 24,337 deceased donor renal transplant recipients (2003-2006) was performed. We developed a nomogram, depicting relative contribution of risk factors, and a novel web-based calculator (http://www.transplantcalculator.com/DGF) as an easily accessible tool for predicting DGF. Risk factors in the modern era were compared with their relative impact in an earlier era (1995-1998). Although the impact of many risk factors remained similar over time, weight of immunological factors attenuated, while impact of donor renal function increased by 2-fold. This may reflect advances in immunosuppression and increased utilization of kidneys from expanded criteria donors (ECDs) in the modern era. The most significant factors associated with DGF were cold ischemia time, donor creatinine, body mass index, donation after cardiac death and donor age. In addition to predicting DGF, the model predicted graft failure. A 25-50% probability of DGF was associated with a 50% increased risk of graft failure relative to a DGF risk < 25%, whereas a > 50% DGF risk was associated with a 2-fold increased risk of graft failure. This tool is useful for predicting DGF and long-term outcomes at the time of transplant., (©2010 The Authors Journal compilation©2010 The American Society of Transplantation and the American Society of Transplant Surgeons.)

As survival of transplant recipients improves, long-term complications become more important. We reviewed epidemiologic literature on real-world risks of de novo neoplasia post-transplant. We searched the Medline/PubMed, Cochrane, and Embase databases for population-based studies on risk of neoplasia from 1998 to 2005. Selection criteria included: solid organ transplants, neoplastic outcomes, n > 500 subjects, age > or = 18 yr, and study design. Of 187 abstracts, 64 met criteria for study size, age range, topic, and design. We classified the articles by quality of reporting on components of cohort studies. Twelve of 64 studies reported cohort eligibility and exclusion criteria, defined time at risk, and ascertained incident neoplasms. Twenty-one studies reported prevalence of neoplasms for unspecified time periods, and only eight incidence studies reported person yr at risk. Three studies of all types of neoplasms in kidney recipients reported incidence ranging from 11.0 to 17.3 cases per 1000 person yr. Two studies of post-transplant lymphoproliferative disorders reported incidence of 0.4 to 2.5 cases per 1000 person yr in kidney recipients. More precise estimation of risks and rates, better description of study population, and more attention to confounding in comparisons of rates would make studies more meaningful. Reports should adhere to established guidelines for presenting methods and results in epidemiologic studies.

After renal transplantation, immunosuppressive regimens associated with high short-term survival rates are not necessarily associated with high long-term survival rates, suggesting that regimens may need to be optimized over time. Calcineurin inhibitor (CNI) withdrawal from a sirolimus-based immunosuppressive regimen may maximize the likelihood of long-term graft and patient survival by minimizing CNI-associated nephrotoxicity. In this study, a lifetime Markov model was created to compare the cost-effectiveness of a sirolimus-based CNI withdrawal regimen (sirolimus plus steroids) with other common CNI-containing regimens in adult de novo renal transplantation patients. Long-term graft survival was estimated by renal function and data from published studies and the US transplant registry, including short- and long-term outcomes, utility weights, and health-state costs were incorporated. Drug costs were based on average daily consumption and wholesale acquisition costs. The model suggests that treatment with sirolimus plus steroids is more efficacious and less costly than regimens consisting of a CNI, mycophenolate mofetil, and steroids; therefore, CNI withdrawal not only shows potential for long-term clinical benefits but also is expected to be cost-saving over a patient's life compared with the most commonly prescribed CNI-containing regimens.

Risk for new-onset diabetes (NOD) after renal transplantation is higher with tacrolimus (Tac) than with cyclosporine (CsA), but the extent to which the diabetogenic effect of Tac is dosage dependent or steroid dependent remains uncertain. Patients who received a transplant between 1995 and 2002 were drawn from the United Network for Organ Sharing registry and prescription records and NOD diagnoses from Medicare claims, both provided by the United States Renal Data System. Patients were divided into six groups of steroid and Tac doses at 30 d after transplantation and referenced against CsA. Relative hazards of NOD with Cox proportional hazards regression were estimated incorporating propensity scores for Tac and nonimmunosuppressive factors related to NOD. A total of 8839 patients with valid immunosuppression records and without pretransplantation evidence of diabetes were included in the study. Unadjusted, cumulative, NOD incidence 1 yr after transplantation was 14.6% with CsA and 22.2% with Tac and at 3 yr after transplantation was 23.4% with CsA and 32.9% with Tac (P < 0.0001). Neither higher CsA nor higher steroid dosages were associated with NOD in CsA-treated patients. However, NOD hazard was significantly higher with Tac than with CsA in all six steroid/Tac dosing groups, including the cohort with the lowest dosages of Tac (dosage thresholds at 30 d after transplantation <0.12 mg/kg per d [mean 0.07 mg/kg per d] and steroids (<0.75 mg/kg per d; hazard ratio 1.28; 95% confidence interval 1.10 to 1.48; P = 0.0012). Whereas the incidence of NOD is greatest with high Tac dosages, the increased risk versus CsA is sustained with lower Tac dosages. Higher steroid dosages increase the early diabetogenic effect of Tac but not of CsA.

Background: Data are scarce regarding the incidence and risk factors for complications of new-onset diabetes mellitus (NODM) in renal transplant patients., Methods: United States Renal Data System (USRDS) data from primary renal transplant recipients during 1995-2001 who developed NODM was used to examine diabetic complications over the first three years posttransplant. Prognostic models were used to evaluate patient characteristics and treatment choices associated with risk of each class of complications. Propensity scores for choice of calcineurin inhibitor were included in multivariate analyses., Results: The analysis included 21,489 patients, of whom 4,105 developed NODM by 3 years posttransplant. One or more NODM complications developed in 2,393 patients (58.3% of all patients with NODM), comprising ketoacidosis (334, 8.1%), hyperosmolarity (131, 3.2%), renal complications (1,286, 31.3%), ophthalmic complications (340, 8.3%), neurological complications (665, 16.2%), peripheral circulatory disorders (170, 4.1%) and hypoglycemia/shock (301, 7.3%). Complications developed within a mean of 500 to 600 days from diagnosis of NODM. Multivariate analysis showed that increased recipient age, higher body mass index, African-American race, hepatitis C infection, hypertension as cause of end-stage renal disease, cold ischemia >or=30 hours, and use of tacrolimus each increased risk of complications., Conclusion: NODM is associated with similar complications to those seen in the general population, but these appear to develop at an accelerated rate. Obesity and use of tacrolimus are the only modifiable factors that appear to affect risk of NODM or its complications.

Objective: This study examines total pharmacy cost and usage patterns of schizophrenic patients in acute mental health inpatient settings for three atypical antipsychotics -- risperidone, olanzapine, and quetiapine. Despite the readily available unit cost information for drugs, actual pharmacy costs may deviate significantly from 'labeled costs'. Recent research findings indicate the need for more robust evaluation of such pharmacy costs., Research Design and Methods: This study used data from non-randomized inpatient retrospective charts from three acute care inpatient mental health facilities. The final pooled sample included 327 patients, of which 120 received risperidone, 153 received olanzapine, and 54 received quetiapine. Medication cost was defined as the average wholesale price (AWP) as listed in the 2001 'Red Book'. Propensity scoring methodology and multinomial regression were employed to reduce treatment selection bias., Results: The observed mean daily antipsychotic drug doses were 4.45 mg (SD 2.44) for risperidone, 14.04 mg (SD 5.55) for olanzapine, and 350.33 mg (SD 228.24) for quetiapine. The corresponding mean daily drug costs were $7.66(SD $4.20) for risperidone, $8.11 (SD $5.29) for quetiapine and, $12.10 (SD $4.79) for olanzepine. Numbers adjusted for treatment selection bias show that the average daily total pharmacy cost of risperidone was $4.35 lower than olanzapine (p < 0.001) and $1.41 lower than quetiapine (p = 0.38). The adjusted average daily pharmacy cost of olanzapine was $4.02 higher than quetiapine (p < 0.001). After statistical adjustment there were no significant differences between study drugs in terms of length of stay or patient functioning., Conclusion: This study provides the first US comparison of medication utilization patterns and pharmacy costs for olanzapine, risperidone, and quetiapine administered in acute mental health care inpatient settings. While this study did not estimate the full economic value of the three antipsychotics in these inpatient settings, it demonstrated that the mean daily costs for risperidone were lower than the mean daily costs for olanzapine (p < 0.001) and quetiapine although the later difference was not statistically significant (p = 0.38).

Delayed graft function (DGF) is the need for dialysis in the first week after transplantation. Studied were risk factors for DGF in adult (age >/=16 yr) cadaveric renal transplant recipients by means of a multivariable modeling procedure. Only donor and recipient factors known before transplantation were chosen so that the probabilities of DGF could be calculated before transplantation and appropriate preventative measures taken. Data on 19,706 recipients of cadaveric allografts were obtained from the United States Renal Data System registry (1995 to 1998). Graft losses within the first 24 h after surgery were excluded from the analysis (n = 89). Patients whose DGF information was missing or unknown (n = 2820) and patients missing one or more candidate predictors (n = 2951) were also excluded. By means of a multivariable logistic regression analysis, factors contributing to DGF in the remaining 13,846 patients were identified. After validating the logistic regression model, a nomogram was developed as a tool for identifying patients at risk for DGF. The incidence of DGF was 23.7%. Sixteen independent donor or recipient risk factors were found to predict DGF. A nomogram quantifying the relative contribution of each risk factor was created. This index can be used to calculate the risk of DGF for an individual by adding the points associated with each risk factor. The nomogram provides a useful tool for developing a pretransplantation index of the likelihood of DGF occurrence. With this index in hand, better informed treatment and allocation decisions can be made.

Wilson's disease is a hereditary defect in copper excretion leading to the accumulation of copper in the tissues, with subsequent tissue damage. The most serious sequela is that of progressive central nervous system involvement. The use of orthotopic liver transplantation (OLT) has been controversial for those patients with neurological symptoms attributed to Wilson's disease. The aim of this study is to determine the effectiveness of OLT for patients with Wilson's disease, including those with neurological involvement attributed to copper accumulation in the central nervous system. OLT was performed in 45 patients (19 men [42.2%], 26 women [57.8%]) with Wilson's disease between 1971 and 1993 who were followed up for at least 4 years. The age at diagnosis of Wilson's disease ranged from 3 to 41 years (mean, 17.7 +/- 7.4 years). The age at OLT ranged from 8 to 52 years (mean, 22.3 +/- 9.4 years). Nineteen patients (42.2%) were aged younger than 18 years at OLT. The indications for OLT included chronic hepatic failure in 15 patients (33.3%) and fulminant (FHF) or subfulminant hepatic failure in 30 patients (66. 6%). All but 1 of the 19 pediatric patients (94.7%) were in the latter group. Twenty-five patients (55.5%) were receiving D-penicillamine, 9 patients for more than 1 year; none of the patients treated long term presented as FHF. Thirty-three patients (73.3%) survived more than 5 years after OLT. Fourteen patients (31%) died during the posttransplantation period; 7 of the 14 patients (50%) were aged younger than 18 years. Twelve patients died during the first 3 months after OLT of complications of disease and surgery, 10 of whom underwent transplantation for FHF. The other 2 patients died 6 and 9 years after transplantation of infectious problems. Eleven patients (24.4%) required retransplantation because of a primary nonfunctioning graft (n = 6), chronic rejection (n = 4), and hepatic artery thrombosis (n = 1). Seventeen patients (37.7%) presented with neurological abnormalities; 14 patients with Wilsonian neurological manifestations and 3 patients with components of increased intracranial pressure. Ten of the 13 surviving patients with hepatic insufficiency and neurological abnormalities at OLT showed significant neurological improvement. Our experience shows OLT is a life-saving procedure in patients with end-stage Wilson's disease and is associated with excellent long-term survival. The neurological manifestation of the disease can improve significantly after OLT. Earlier transplantation in patients with an unsatisfactory response to medical treatment may prevent irreversible neurological deterioration and less satisfactory improvement after OLT.

A novel bioequivalence testing approach was used to determine intrasubject variability and switchability of two ciclosporin formulations, SangCya (test) and Neoral (reference). Twenty healthy volunteers were enrolled into a single-dose, randomized, open-label, 4-period, 2-sequence study with a crossover replicate design. Subject-by-formulation interaction variances were compared using a mixed effects linear model. Intrasubject variability for ln AUC(0-infinity) and ln C(max) of SangCya and Neoral were not significantly different. The 95% confidence intervals of the intrasubject variability of AUC(0-infinity) (0.94) and C(max) (1.28) as determined using the bootstrap nonparametric percentile method (n = 2,000) were below the individual bioequivalence limit estimated at 2.25. We concluded equivalent intrasubject variability of ciclosporin pharmacokinetics and switchability between SangCya and Neoral.

Legionella pneumophila is an important pathogen that may cause nosocomial and community-acquired pneumonia in patients with normal or altered immunity. The epidemiology of 40 cases of legionella pneumonia in patients hospitalized between 1986 and 1994 was studied. Fourteen patients (35%) were solid organ transplant recipients. The calculated annual incidence of L. pneumophila infection was highest among lung transplant recipients (2.07 cases per 1,000 transplant-years). There was a trend toward reduced mortality rates and less severe disease among transplant patients vs. nontransplant patients: mortality rate, 36% vs. 54%; incidence of intubation, 50% vs. 69%; rate of concurrent infections, 29% vs. 38%; and overall rate of complications, 86% vs. 96%; respectively. In a multivariate analysis, factors independently associated with an increased mortality rate were nosocomial acquisition, need for intubation, formation of lung abscess or cavitation, and presence of pleural effusion. Thus, despite differing host immune responses, the most important prognostic factors affecting the outcome of legionellosis are nosocomial acquisition and the development of pulmonary complications.

Between January 1987 and October 1991, 1466 patients underwent consecutive Orthotopic Liver Transplantation (OLTx) at the University of Pittsburgh. Forty of these patient's had concomitant splenectomy with OLTx. These patients were compared to 147 randomly selected OLTx patients without splenectomy within the same time period. One-year patient and graft survival (PS and GS) were lower in splenectomized (Splx) patients compared to nonsplenectomized (non-Splx) patients (59% vs 86% PS, 55% vs 80% GS, respectively). One-month and one-year patient mortality in the Splx group was higher than in the non-splx patients (20% vs 3.4%, P < 0.001 for one month; 40% vs 14.3%, P = 0.003 for one year, respectively). One-month and one-year sepsis-related mortality was also high in Splx patients (17.5% vs 2.7%, P = 0.0022, for one month, and 30% vs 11.5%, P = 0.0043, for one year, respectively). We conclude that concomitant splenectomy with OLTx has a significantly higher patient mortality mainly due to its septic complications and, at present, unless there is a specific indication for a splenectomy, the routine addition of this procedure to liver allograft surgery would not be recommended.

Purpose: To help investigators decide if new therapies for glioma warrant definitive evaluation in randomized studies we have been developing a method for assessing the degree to which patient selection may have enhanced the results of uncontrolled treatment trials. In this study, we analyzed the impact of case selection on the survival of patients with malignant glioma receiving adjuvant stereotactic radiosurgery, a promising therapy reserved for those with small tumors and good performance status., Methods: Following published eligibility criteria we simulated the patient selection process for stereotactic radiosurgery given as a boost at the conclusion of conventional radiotherapy. Eligible patients were culled from a pre-existing clinical/imaging database of 101 consecutive conventionally-treated patients with biopsy-proven malignant glioma and known survival times. Median durations of survival and 2- and 3-year survival rates were determined for those judged eligible or ineligible for stereotactic radiosurgery., Results: Twenty-seven percent of patients were deemed eligible for stereotactic radiosurgery, eligible patients had more favorable prognostic factors and significantly longer median survival than ineligible patients (23.4 vs. 8.6 months; 2-year rate, 48% vs. 15%; 3-year rate, 30% vs. 7%); eligible patients also had a longer median survival than the entire group of unselected patients (23.4 vs. 11.4 months). Radiosurgery-eligible, conventionally-treated patients with glioblastoma multiforme and a group of radiosurgery-treated patients at a special referral center had similar median survival times (16.4 vs. 19.7 months)., Conclusion: We provide additional evidence for selection bias in uncontrolled trials of stereotactic radiosurgery and by simulating the selection process accurately have detected a larger bias effect than noted previously. Judging from experience with interstitial radiation and intraarterial chemotherapy where substantial selection bias also occurred and randomized controlled trials proved disappointing, we conclude that a phase III study of stereotactic radiosurgery for malignant glioma is unlikely to yield a positive result and may not be necessary.

FK 506 was used as a primary immunosuppressive agent in 125 cases of renal transplantation in a randomized trial comparing FK 506/prednisone with FK 506/azathioprine/prednisone. With a mean follow-up of 5.5 +/- 2.5 months, there has been a 6-month actuarial patient survival of 99% and graft survival of 88%. There is no difference thus far between the two-drug and three-drug groups, although there may be less rejection and diabetes in the three-drug group. These results suggest that FK 506 is a useful immunosuppressive agent in kidney transplantation.

Interstitial irradiation is a promising treatment for malignant glioma. Longer than expected survival periods following treatment of recurrent tumor have led to the use of brachytherapy as an adjuvant treatment. The impact of patient selection on survival data was studied among candidates for this therapy. Consecutive, conventionally treated adults with newly diagnosed supratentorial tumors were identified retrospectively at a center where experience with glioma is population-based. Based on imaging and performance status, two surgeons and a radiation oncologist designated each patient as either eligible or ineligible for adjuvant brachytherapy. The survival and prognostic factors in the eligible and ineligible groups were analyzed. Overall, the patients eligible for brachytherapy (32% of the series) lived significantly longer than the ineligible patients (16.57 vs. 9.30 months), were younger, and had larger resections and better function. For glioblastoma, 40% of patients were eligible, and lived much longer than those who were ineligible (13.90 vs. 5.80 months). It is concluded that better outcome following adjuvant brachytherapy for glioma is at least in part the result of patient selection. Randomized trials of comparably selected patients will be necessary to demonstrate conclusively that longer survival is also a result of treatment.

When an automatic defibrillator is implanted, it is essential to determine the efficacy of the defibrillating system accurately, while balancing the need to keep the number of fibrillation episodes to a minimum. Two methods have evolved to assess defibrillation efficacy: 1) the "defibrillation threshold," which requires few ventricular fibrillation episodes, and 2) the "dose-response curve," which requires many ventricular fibrillation episodes and relates percent success to energy. The purpose of this study was to compare these two methods directly. Twenty open-chest anesthetized pigs had triplicate defibrillation threshold determinations. To produce a dose-response curve, six shocks then were delivered at 0.5, 0.75, 1.0, 1.25, 1.5, and 2.0 times the mean defibrillation threshold, in a balanced randomized order, during separate episodes of ventricular fibrillation. The data were fitted by logistic regression, conversions of the logistic regression, and a saturable exponential and nonsaturable growth exponential. A comparison was made of the mean defibrillation threshold and the 50% point on the dose-response curve (ED50) for each model, for each animal. In addition, the reliability of each measure was assessed by comparing the coefficients of variation. There was no statistical difference between the group defibrillation threshold (6.6 +/- 0.5 J) and group ED50 values (ED50 range of the models, 5.7 +/- 1.9 to 7.0 +/- 0.9 J). However, the variability about the defibrillation threshold was less than that of the ED50 values for all mathematical models except the true logistic equation, which was virtually the same.(ABSTRACT TRUNCATED AT 250 WORDS)