Alignment of Physician-Stated vs Clinically Derived Reference Fibrosis Score in Patients with Non-Alcoholic Steatohepatitis: A Real-World European Survey.

Objective: Stratifying disease severity in patients with non-alcoholic steatohepatitis (NASH) is essential for appropriate treatment and long-term management. Liver biopsy is the reference standard for fibrosis severity in NASH, but less invasive methods are used, eg, Fibrosis-4 Index (FIB-4) and vibration-controlled transient elastography (VCTE), for which reference thresholds for no/early fibrosis and advanced fibrosis are available. We compared subjective physician assessment of NASH fibrosis versus reference thresholds to understand classification in a real-world setting. Methods: Data were drawn from Adelphi Real World NASH Disease Specific ProgrammeTM conducted in France, Germany, Italy, Spain and UK in 2018. Physicians (diabetologists, gastroenterologists, hepatologists) completed questionnaires for five consecutive NASH patients presenting for routine care. Physician-stated fibrosis score (PSFS) based on available information was compared with clinically defined reference fibrosis stage (CRFS) determined retrospectively using VCTE and FIB-4 data and eight reference thresholds. Results: One thousand two hundred and eleven patients had VCTE (n = 1115) and/or FIB-4 (n = 524). Depending on thresholds, physicians underestimated severity in 16-33% (FIB-4) and 27-50% of patients (VCTE). Using VCTE ≥12.2, diabetologists, gastroenterologists and hepatologists underestimated disease severity in 35%, 32%, and 27% of patients, respectively, and overestimated fibrosis in 3%, 4%, and 9%, respectively (p = 0.0083 across specialties). Hepatologists and gastroenterologists had higher liver biopsy rates than diabetologists (52%, 56%, 47%, respectively). Conclusion: PSFS did not consistently align with CRFS in this NASH real-world setting. Underestimation was more common than overestimation, potentially leading to undertreatment of patients with advanced fibrosis. More guidance on interpreting test results when classifying fibrosis is needed, thereby improving management of NASH.

Real-world management of non-alcoholic steatohepatitis differs from clinical practice guideline recommendations and across regions.

BACKGROUND & AIMS: Despite availability of diagnostic and management reference guidelines outlining standard of care for patients with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), national and regional guidelines are lacking, resulting in variations in patient management between regions. We retrospectively analyzed patient characteristics and management data from the Adelphi Real World NASH Disease Specific Programme™ for patients with NASH in the EU5, Canada, and the Middle East to identify gaps between real-world practice and that advocated by reference guidelines, irrespective of clinician awareness or consultation of guidelines. METHODS: We performed an analysis of physicians (hepatologists, gastroenterologists, diabetologists) and their patients diagnosed with NASH. Physicians completed patient record forms for the next 5 consulting patients, collecting information on patient care, including diagnosis and disease management. RESULTS: A total of 429 physicians provided data for 2,267 patients with NASH (EU5, n = 1,844; Canada, n = 130; Middle East, n = 293). Patient age, physician-defined fibrosis stage, comorbidities and symptoms, and diagnostic testing practices highlighted statistically significant differences across regions. Substantial disconnects between reference guidelines and real-world practice were observed. Use of liver function tests, non-invasive tests (e.g. ultrasound and transient elastography), and tests to exclude other conditions was suboptimal. Although lifestyle advice was widely provided, patients were less commonly referred to diet, exercise, and lifestyle specialists. Two-thirds of patients were receiving off-label treatment for NASH or associated underlying conditions with the aim of improving NASH, most commonly statins, metformin, and vitamin E. CONCLUSION: Real-world NASH management approaches differ across regions and from proposed standard of care represented by reference multidisciplinary guidelines. Establishment and awareness of, and adherence to regional and national guidelines may improve identification and management of patients with NASH and potentially improve outcomes in this population. LAY SUMMARY: Although reference guidelines are available to guide the management of patients with NASH, these are not widely used and there is a lack of national guidelines. Our study shows how clinical practice in the EU, Canada, and Middle East differs from proposed standard of care, particularly relating to how patients are diagnosed and treated. Wider establishment of, awareness of, and reference to guidelines may improve how physicians identify and manage patients with NASH.

Cost Effectiveness of Screening for Hepatitis C Virus in Iraq in the Era of Simplified Testing and Treatment.

BACKGROUND AND OBJECTIVE: Recent advances in hepatitis C virus (HCV) diagnostic testing methods allow for a one-stop simplified 'test and cure' approach. The cost effectiveness of incorporating this simplified approach into HCV screening in Iraq remains uncertain. This study aimed to compare the cost effectiveness of different HCV testing and diagnostic approaches, and screening strategies in Iraq from a health service perspective. METHODS: A cost-effectiveness analysis was undertaken using a hybrid model comprising a screening decision tree linked to a lifetime Markov model to estimate outcomes in HCV-infected people. Cost and utility estimates were sourced from the published literature and expert guidance provided by clinicians and policy makers in Iraq. Cost estimates were reported in 2019 USD or 2019 Iraqi Dinar and both costs and benefits were discounted at 3.5% annually. RESULTS: Strategies using a simplified approach were found to be cost saving in addition to improving patient outcomes when compared with a standard testing and diagnostic approach. When considering risk-based screening, a simplified approach was associated with a total cost saving of Iraqi Dinar 4375 billion (USD 3.7 billion) and per patient life-year and quality-adjusted life-year gains of 0.30 and 0.55, compared with a standard approach. Benefits and cost savings were driven by a 32.2% and 23.6% reduction in the incidence of cirrhosis and hepatocellular carcinoma, respectively. Estimated benefits and cost savings increased under total population screening. All screening and testing and diagnostic approaches were cost effective compared with a no screening scenario. CONCLUSIONS: Improvements in the detection of HCV combined with a simplified one-stop testing and diagnostic approach represents an opportunity to reduce the burden of HCV in Iraq and may play a significant role in meeting World Health Organisation HCV elimination targets.

Clinical and economic burden of nonalcoholic steatohepatitis in Saudi Arabia, United Arab Emirates and Kuwait.

BACKGROUND AND AIMS: The Middle East (ME) has a high prevalence of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), driven by obesity and type-2 diabetes mellitus (T2DM). Studies in Saudi Arabia (KSA) and United Arab Emirates (UAE) predict an escalating impact of NAFLD/NASH, particularly advanced fibrosis due to NASH (AF-NASH), increasing cases of cirrhosis, liver cancer and death. The scale of this burden in other ME countries is unknown with no reports of NAFLD/NASH healthcare resource utilization (HCRU) or costs. We estimated the clinical and economic burden of NAFLD/NASH in KSA, UAE and Kuwait. METHODS: Markov models populated with country-specific obesity and T2DM prevalence data estimated numbers and progression of NAFLD/NASH patients from 2018 to 2030. Model inputs, assumptions and outputs were collected from literature, national statistics, and expert consensus. RESULTS: Over 13 years, the KSA model estimated cases increasing as follows: patients with fibrosis F0-3 doubled to 2.5 m, compensated and decompensated cirrhosis and hepatocellular carcinoma trebled to 212,000; liver failure or transplant patients increased four-fold to 4,086 and liver-related death escalated from < 10,000 to > 200,000. Similar trends occurred in UAE and Kuwait. Discounted lifetime costs of NASH standard-care increased totaling USD40.41 bn, 1.59 bn and 6.36 bn in KSA, UAE (Emiratis only) and Kuwait, respectively. NASH-related costs in 2019 comprised, respectively, 5.83%, 5.80% and 7.66% of national healthcare spending. CONCLUSIONS: NASH, especially AF-NASH, should be considered a higher priority in ME Public Health policy. Our analyses should inform health policy makers to mitigate the enormity of this escalating regional burden.

Hepatitis B care pathway in Jordan: current situation, gaps and recommended actions.

OBJECTIVES: Hepatitis B virus (HBV) infection remains a worldwide public health problem. The last major review of the HBV care pathway in the Middle East was published in 2011. This article aims to assess the current situation of the HBV care pathway in Jordan, identify gaps and barriers and recommend initiatives that could be taken to improve disease management across all stages of the care pathway. METHODS: A Delphi process was used between February and October 2017, including a literature review (PubMed and Google Scholar) for published articles on HBV in Jordan, followed by individual interviews with various healthcare professionals and group discussions with leading Jordanian hepatologists and gastroenterologists to provide context to the results of the literature review. RESULTS AND DISCUSSION: The national prevalence of HBV is estimated to be around 2.4% and has declined from 9.9% in the pre-vaccination era. There is limited data on the burden of HBV-related hepatocellular carcinoma in the country. Awareness of various aspects of the disease is considered low among the general population and medium among primary care providers. There are several mandated national screening structures, however, established protocols for those that test positive and subsequent linkage-to-care are not optimal. In conclusion, significant improvements have been made in the past 30 years in Jordan in terms of decline in HBV prevalence. However, efforts must be made by all key stakeholders to optimise screening and linkage-to-care of patients and reduce both morbidity and mortality in the country.

Prevalence and risk factors for primary hyperparathyroidism in hyperthyroid patients.

BACKGROUND: Coexistence of hyperthyroidism and primary hyperparathyroidism may be more prevalent than previously recognized. We report 13 cases of concomitant occurrence of both diseases to estimate their combined prevalence and its factors. METHODS: Ninety-six unselected patients admitted for elective hyperthyroidism surgery were retrospectively included. Eighty-three patients were initially seen for hyperthyroidism with normocalcemia (group 1), and 13 patients were initially seen for hyperthyroidism with associated primary hyperparathyroidism (group 2). Patients' characteristics, examinations, and pathology reports were reviewed. Risk factors were identified using a logistic regression model. RESULTS: The prevalence of concomitant hyperparathyroidism was 13.5%. No patients manifested hypercalcemia in the absence of organic parathyroid disease. Eleven patients had a parathyroid adenoma, and two patients had parathyroid hyperplasia. Group 2 patients were older (median 61 vs 43 years, p = .006). Thyroid-stimulating hormone levels were more depressed in group 2 (median 0.01 vs 0.032 UI/L, p = .034). On multivariate analysis, age was the unique factor significantly different between groups (odds ratio, 1.05; 95% confidence interval, 1.008-1.098; p = .020). CONCLUSIONS: Hypercalcemia in patients with hyperthyroidism, particularly older patients, should warrant a thorough investigation for concomitant primary hyperparathyroidism that would dictate a combined thyroidectomy and parathyroidectomy.

Existence and anatomic distribution of double parathyroid adenoma.

BACKGROUND: Double parathyroid adenomas occur in 2% to 15% of primary hyperparathyroidism cases, but the very existence of double adenomas has been controversial. This study was conducted to evaluate the clinical significance and anatomic distribution of parathyroid double adenomas. STUDY DESIGN: Mono-institutional retrospective study of the medical records of 183 unselected consecutive patients who underwent intervention for primary hyperparathyroidism between 1996 and 2003. RESULTS: A total of 14 (7.65%) patients were found to have double parathyroid adenomas. Intraoperative parathyroid hormone (PTH) levels were measured in every case. Two enlarged parathyroid glands were identified in four possible configurations: two both superior, one both inferior, two both right, three both left, two right superior and left inferior, and three left superior and right inferior. There was a preferential crossed bilateral distribution of double adenomas. In all patients, intraoperative PTH levels dropped by at least 50% from baseline after removal of both abnormal parathyroid glands. In this series, no patient developed persistent hypoparathyroidism or had recurrent laryngeal nerve injuries or neck hematoma. All patients remained normocalcemic 9 to 96 months postoperatively. One patient had persistently elevated PTH values with normal serum calcium levels. CONCLUSION: The drop in intraoperative PTH levels and maintenance of normocalcemia postoperatively confirm previous reports that double adenomas do exist and are not simply missed cases of four-gland hyperplasia. There was a preferential crossed bilateral distribution of double adenomas in this series.