Simplified care-pathway selection for nonspecialist practice: the GLOBAL Primary Biliary Cholangitis Study Group Age, Bilirubin, Alkaline phosphatase risk assessment tool.

BACKGROUND: Opportunity to redefine the care journeys for those living with primary biliary cholangitis (PBC) includes facilitating access to enhanced (PBC-dedicated) programmes by nonspecialist risk 'flagging' of patients. OBJECTIVE: To develop a nonexpert PBC stratification tool to help care pathway choices (standard vs. enhanced) choices in PBC. METHODS: We included ursodeoxycholic acid-treated patients with PBC from the Global PBC Study Group. The performance of baseline and 1-year clinical markers with transplant-free survival was assessed to develop the 'ABA' tool using Age (A), Bilirubin (B), and Alkaline phosphatase (A). Added value of fibrosis estimation was assessed. RESULTS: 'ABA' classification mapped three risk groups (n = 2226): low [Age > 50 years, bilirubin ≤ 1 × ULN, alkaline phosphatase (ALP) ≤ 3 × ULN], high (Age ≤ 50 years, bilirubin > 1 × ULN, ALP > 3 × ULN), and intermediate (other). Transplant-free survival at 10 years in the low-, intermediate-, and high-risk groups were 89, 77, and 59% at baseline and 86, 76, and 40% at 1 year, respectively. We propose that high-risk patients at baseline be directly triaged to enhanced (PBC-dedicated) care and the remaining be reassessed at 1 year. Modelling showed after 1 year 46% patients were proposed to enhanced care and 54% to standard care. The 'ABA' mapped pathways facilitated identification of patients at risk based on a young age, as compared to traditional liver biochemical stratification. In patients proposed to standard care, estimated fibrosis stage had ongoing prognostic value. CONCLUSION: Nonspecialist use of the 'ABA' risk tool could prioritize care journey choices for patients with PBC.

Consensus guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury occurring during clinical trials in adults with chronic cholestatic liver disease.

BACKGROUND: Improved knowledge of the molecular pathophysiology and immunopathogenesis of cholestatic liver diseases in recent years has led to an increased interest in developing novel therapies. Patients with cholestatic liver disease often require different approaches to assessment and management of suspected drug-induced liver injury (DILI) compared to those with healthy livers and those with parenchymal liver diseases. At present, there are no regulatory guidelines or society position papers, that systematically address best practices pertaining to detection of DILI in these patients. AIMS: To outline best practices for detection, assessment and management of suspected acute DILI during clinical trials in adults with the cholestatic liver diseases - Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC). METHODS: This is one of the several papers developed by the IQ DILI Initiative, which is comprised of members from 16 pharmaceutical companies, in collaboration with DILI experts from academia and regulatory agencies. The contents are the result of an extensive literature review, as well as in-depth discussions among industry, regulatory and academic DILI experts, to achieve consensus recommendations on DILI-related issues occurring during clinical trials for cholestatic liver diseases. RESULTS: Recommended best practices are outlined pertaining to hepatic eligibility criteria, monitoring of liver tests, approach to a suspected DILI signal, and hepatic discontinuation rules. CONCLUSIONS: This paper provides a framework for the approach to detection, assessment and management of suspected acute DILI occurring during clinical trials in adults with cholestatic liver disease.

Commentary: improving medical education during financially challenging times.

The expectation exists that medical education will continue to improve even during financially challenging times. The authors reviewed their recent experiences in effecting positive changes and improvements in Mayo Medical School during a time of fiscal constraint. They successfully implemented numerous changes, including a major curriculum reform, while modestly reducing overall costs of the medical school and improving student satisfaction and learner outcomes. These improvements resulted from careful alignment among the institutional mission of serving the needs of the patient, communication with the faculty, involvement of the students, and streamlining of multiple processes throughout the school. The authors sought to eliminate excessive resource utilization while retaining the essence of Mayo Medical School's education process. The authors' experience can both encourage and inspire other schools to continue to improve the educational experience for their students in concert with meeting increasing financial pressures.

A discrete event simulation model to evaluate operational performance of a colonoscopy suite.

BACKGROUND AND AIMS: Colorectal cancer, a leading cause of cancer death, is preventable with colonoscopic screening. Colonoscopy cost is high, and optimizing resource utilization for colonoscopy is important. This study's aim is to evaluate resource allocation for optimal use of facilities for colonoscopy screening. METHOD: The authors used data from a computerized colonoscopy database to develop a discrete event simulation model of a colonoscopy suite. Operational configurations were compared by varying the number of endoscopists, procedure rooms, the patient arrival times, and procedure room turnaround time. Performance measures included the number of patients served during the clinic day and utilization of key resources. Further analysis included considering patient waiting time tradeoffs as well as the sensitivity of the system to procedure room turnaround time. RESULTS: The maximum number of patients served is linearly related to the number of procedure rooms in the colonoscopy suite, with a fixed room to endoscopist ratio. Utilization of intake and recovery resources becomes more efficient as the number of procedure rooms increases, indicating the potential benefits of large colonoscopy suites. Procedure room turnaround time has a significant influence on patient throughput, procedure room utilization, and endoscopist utilization for varying ratios between 1:1 and 2:1 rooms per endoscopist. Finally, changes in the patient arrival schedule can reduce patient waiting time while not requiring a longer clinic day. CONCLUSIONS: Suite managers should keep a procedure room to endoscopist ratio between 1:1 and 2:1 while considering the utilization of related key resources as a decision factor as well. The sensitivity of the system to processes such as turnaround time should be evaluated before improvement efforts are made.

Diagnostic model of esophageal varices in alcoholic liver disease.

Esophageal varices may cause life-threatening bleeding with attendant high hospital cost. Since effective preventive modalities for variceal hemorrhage have been established, early detection of esophageal varices is critical for prevention of bleeding. Currently, endoscopic screening is widely recommended to patients who have the diagnosis of cirrhosis. However, the diagnosis of cirrhosis relies on histological evaluations, which is costly and invasive, and endoscopic screening also burdens medical resources. Recent cost-effectiveness studies suggested that empiric prophylaxis with beta-blockers may be viable in comparison with endoscopic screening in patients with cirrhosis. However, this issue need to be also evaluated taking account of societal and patient perspectives and is not yet decided. An accurate non-invasive diagnostic model to predict the presence of esophageal varices may reduce unnecessary endoscopic procedures and prophylactic medication and improve cost-benefit of these approaches. Use of an accurate serum marker for severe hepatic fibrosis may also improve accuracy of non-invasive diagnostic models. Hyaluronic acid, a serum marker for severe hepatic fibrosis, has been reported to have a high diagnostic performance in assessing the severity of hepatic fibrosis in patients with alcoholic liver disease. In this issue, a non-invasive diagnostic model including hyaluronic acid was shown to have excellent performance in excluding the presence of medium to large esophageal varices in severe alcohol abusers. Based on current evidence, the strategy of using a non-invasive diagnostic model together with a serum marker for severe hepatic fibrosis may improve cost-benefit in the prevention of variceal hemorrhage among patients with alcoholic liver disease. The independent verification of such diagnostic models is needed.

Cost-minimization analysis of MRC versus ERCP for the diagnosis of primary sclerosing cholangitis.

Investigations examining the use of magnetic resonance cholangiography (MRC) for the diagnosis of primary sclerosing cholangitis (PSC) have described comparable accuracy when compared to endoscopic retrograde cholangiopancreatography (ERCP). The effectiveness of MRC based on overall cost, however, remains unknown. Our aim was to determine the average cost per correct diagnosis using MRC or ERCP as the initial testing strategy for the diagnosis of PSC. A decision analysis model was constructed employing diagnostic test parameters prospectively determined among 73 patients with clinically suspected biliary disease. ERCP was performed within 24 hours after MRC. Cost data were derived from average Medicare reimbursement fee schedules. The prevalence of PSC in the study cohort was 32%. The sensitivity and specificity of MRC for the diagnosis of PSC were 82% and 98%, respectively. The average cost per correct diagnosis of PSC was 724.00 US dollars for initial MRC (including the cost of ERCP following a negative MRC examination) versus 793.17 US dollars for initial ERCP. In the absence of biliary obstruction, the average cost per correct diagnosis of PSC was 549.64 US dollars with MRC versus 623.25 US dollars or ERCP. The average cost of managing post-ERCP-related complications among patients with PSC was 2902.20 US dollars (range, 1915.40-5031.54 US dollars). For ERCP to be the optimal initial test strategy, a prevalence rate of PSC greater than 45%, MRC specificity less than 85%, or reduction in the average cost per diagnosis to 538.30 US dollars would be required. In conclusion, MRC has comparable accuracy to ERCP and results in cost savings when used as the initial test strategy for diagnosing PSC.

A novel incentive system for faculty in an academic medical center.

The need to contain health care costs has led some physicians to become salaried employees of health care organizations. However, the use of nonfinancial incentives for physicians in such an environment has not been broadly explored. The authors describe a novel incentive system that is designed to promote continuing high-quality care and to increase patient access to health care while enhancing clinical and academic productivity and physician satisfaction. Key components of this system include annual targets, flexibility in meeting these targets, and ability to convert clinical productivity generated in excess of what was necessary to meet the target to support scholarly activities. This system led to increased faculty productivity, improved patient access, enhanced scholarly activity, and overall enhanced career satisfaction.