Which is more cost‐effective under the MELD system: primary liver transplantation, or salvage transplantation after hepatic resection or after loco‐regional therapy for hepatocellular carcinoma within Milan criteria?

AbstractObjectiveThe 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.MethodsA 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.ResultsBoth 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 3.1QALYs (at US$96000/QALY) and LRT/SOLT yielded 3.9QALYs (at US$74000/QALY), whereas POLT yielded 5.5QALYs (at US$52000/QALY). Sensitivity analyses supported these findings at clinically meaningful probabilities.ConclusionsUnder 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

Is liver transplantation using organs donated after cardiac death cost‐effective or does it decrease waitlist death by increasing recipient death?

AbstractObjectivesThe 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).MethodsA 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.ResultsOverall 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.conclusionsThe 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

Which is more cost‐effective under the MELD system: primary liver transplantation, or salvage transplantation after hepatic resection or after loco‐regional therapy for hepatocellular carcinoma within Milan criteria?

AbstractObjectiveThe 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.MethodsA 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.ResultsBoth 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 3.1QALYs (at US$96000/QALY) and LRT/SOLT yielded 3.9QALYs (at US$74000/QALY), whereas POLT yielded 5.5QALYs (at US$52000/QALY). Sensitivity analyses supported these findings at clinically meaningful probabilities.ConclusionsUnder 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

Effect of Statin Intensity on the Progression of Cardiac Allograft Vasculopathy

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

The comparability of linear and nonlinear latent variable analyses of skewed dichotomous items

Factor-analytic methods founded on the multivariate linear model are often employed to scale behavior rating instruments. When items are scored as dichotomies and endorsements are skewed, the data violate the assumption of a multivariate normal distribution (MND). While the mathematical ramifications of such have been widely characterized, an empirical evaluation of MND- and non MND-based latent variable solution concordance has not been reported. This research investigated whether MND-based latent variable models employing previously-reported latent dimension extraction and item retention restrictions yielded a solution which was supported by two methods which do not assume a MND: (a) bi-factor analysis, and (b) latent class analysis. Standardization data of the Bristol Social Adjustment Guides, an instrument which evaluates social adjustment in school, were randomly divided into scaling (N = 1,505) and confirmatory (N = 1,000) samples. Scaling methods included: (a) first-order principal component analysis (PCA) and common factor analysis (CFA), (b) second-order CFA, and (c) confirmatory, oblique, principal-component cluster analysis. Bi-factor and latent class models evaluated the goodness-of-fit of confirmatory sample data to the item structure and behavior styles indicated via MND-based linear scaling. One solution comprising four first-order and two second-order latent dimensions, overactivity (OVER) and underactivity (UNDER), was derived and supported by both confirmatory methods. The bi-factor model was superior to simple structure for OVER and UNDER items, X\sp2 difference: OVER (39, N = 1,000) = 67, $p \u3c .005$; and UNDER (33, N = 1,000) = 100, $p \u3c .005$. A three-dimensional (over-, under-, and normoactivity) confirmatory latent class model was fitted, X\sp2 (4, N = 1,000) = 1.29, $p \u3e .80$, while alternative one- and two-class models were rejected at the $\u3c$.01 alpha level. PCA and CFA yield concordant solutions with dichotomous, skewed, item data under accepted extraction and retention criteria. Latent structures identified through MND-based linear factoring are, under these circumstances, supported by models which do not assume a MND

Sexual boundary violation index: A validation study

This paper explores the psychometric properties of the Boundary Violation Index (BVI), a screening instrument designed to assess the attitudes, thoughts, and behaviors of physicians at risk of sexual misconduct with patients and staff. Items for the BVI were selected and validated using a two phase process of administration of the tool along with the Sexual Addiction Screening Test (SAST) to physicians referred to a CME course for boundary violating behaviors (n = 60 and 272) along with a control group (n = 118). Criterion-related validity in relation to the SAST was strong (r = 0.68, p \u3c 0.001) and construct validity was demonstrated by the difference between intervention and comparison group BVI scores (p \u3c 0.001). A BVI score of ≥6 for interpreting substantive risk had a sensitivity of 83% and specificity of 81%, and represented a greater than 20-fold greater risk (Exp B = 20.5, 95% CI 11.8-35.7, model p \u3c 0.001) for membership in the intervention group. The BVI offers promise as a preliminary tool for identification of physicians at risk for boundary violating behaviors and may have utility for medical education and/or monitoring purposes

Improvement of survival with response to neoadjuvant radiation therapy for rectal cancer

To determine whether patients with a complete or near-complete response to neoadjuvant radiation therapy (XRT) have improved survival compared with those with less of a response and to compare survival between patients with disease downstaged after neoadjuvant XRT and patients with stage I disease undergoing resection alone. Retrospective cohort of 10,971 patients (3760 patients with neoadjuvant XRT; 7211 with stage I disease with resection alone) from the Surveillance, Epidemiology, and End Results registry using data from January 1, 1994, through December 31, 2003. Overall survival and disease-specific survival (DSS) of patients undergoing resection for nonmetastatic rectal adenocarcinoma receiving neoadjuvant XRT and patients with stage I disease undergoing surgical resection alone. The 5-year DSS and overall survival were 94% and 82%, respectively, for responders to neoadjuvant XRT, 78% and 60%, respectively, for nonresponders, and 97% and 79%, respectively, for patients with stage I disease undergoing resection alone. Responders had improved DSS (P < .001) and overall survival (P < .001) compared with nonresponders by Cox regression. Patients with stage I disease undergoing resection alone had improved DSS (P = .01) but not overall survival (P = .89) compared with XRT responders. Patients with rectal adenocarcinoma downstaged after neoadjuvant XRT have improved survival compared with nonresponders. While DSS is excellent for responders to neoadjuvant XRT, it did not equal the DSS of patients with stage I disease undergoing resection alone

Biliary reconstruction using non-penetrating, tissue everting clips versus conventional sewn biliary anastomosis in liver transplantation

Background. Biliary complications occur following approximately 25% of liver transplantations. Efforts to decrease biliary complications include methods designed to diminish tissue ischemia. Previously, we reported excellent short-term results and decreased biliary anastomosis time in a porcine liver transplant model using non-penetrating, tissue everting clips (NTEC), specifically VCS® clips. Methods. We examined the incidence of biliary anastomotic complications in a group of patients in whom orthotopic liver transplantation was performed with biliary reconstruction using NTEC and compared that group to a matched group treated with biliary reconstruction via conventional end-to-end sewn choledochocholedochostomy. Patients were matched in a 1:2 fashion by age at transplantation, disease etiology, Child-Turcot-Pugh scores, MELD score or UNOS status (prior to 1998), cold and warm ischemia times, organ donor age, and date of transplantation. Results. Seventeen patients had clipped anastomosis and 34 comparison patients had conventional sewn anastomosis. There were no differences between groups in terms of baseline clinical or demographic data. The median time from completion of the hepatic artery anastomosis to completion of clipped versus conventional sewn biliary anastomosis was 45 (interquartile range = 20 min) versus 47 min (interquartile range = 23 min), respectively (p=0.12). Patients were followed for a mean of 29 months. Biliary anastomotic complications, including leak or anastomotic stricture, were observed in 18% of the clipped group and 24% of the conventional sewn group. Conclusions. Biliary reconstruction can be performed clinically using NTEC as an alternative to conventional sewn biliary anastomoses with good results