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.

Outcomes following oesophageal stent insertion for palliation of malignant strictures: A large single centre series.

BACKGROUND: Self-expanding metal stents (SEMS) are an accepted intervention for malignant dysphagia. Stents vary in ease of insertion, removability, migration and occlusion rates. This series reports the complications, morbidity and mortality associated with several SEMS. METHOD: A prospective database of patients undergoing fluoroscopic guided oesophageal stent insertion for malignancy between June 2001 and June 2009 was analysed. Patient demographics, intervention outcomes and tumour variables were correlated with stent failure and patient survival. Multivariate analysis was performed to evaluate predictors for stent failure. RESULTS: Two hundred and seventy-three stents were deployed using nine different types of SEMS. The median Mellow-Pinkas dysphagia score significantly improved from 3 to 1 post-stent insertion (P < 0.001), with a technical success rate of 98%. Stent complications occurred in 95 (36%) patients [recurrent dysphagia n = 49 (19%), migration n = 24 and occlusion n = 25]. Multivariate analysis demonstrates that the covered Niti S stent fails significantly more than the double-layered Niti S stent (OR = 4, P < 0.005). CONCLUSION: Oesophageal stent insertion provides good palliation for malignant dysphagia, however recurrent dysphagia remains a problem. This major complication occurs more frequently with covered Niti S stents than double-layered Niti S stents. This finding may aid the stent choice used in advanced oesophageal malignancy.

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.

The association between compliance and persistence with bisphosphonate therapy and fracture risk: a review.

BACKGROUND: Sub optimal levels of compliance and persistence with bisphosphonates are potentially compromising the reduction of post menopausal osteoporotic (PMO) fracture risk. METHODS: A structured literature search (1990-2006) was performed to identify primary research studies evaluating the relationship between compliance and persistence with bisphosphonates and post menopausal osteoporotic (PMO) fracture risk in clinical practice. Search criteria were: bisphosphonates; osteoporosis/osteopenia in postmenopausal women; all types of fractures; compliance and persistence. RESULTS: Only two retrospective studies using prescription databases have specifically evaluated bisphosphonates.A cohort study tracking 35,537 women reported that in those with a Medication Possession Ratio (MPR) of > or =80% over 24 months the risk of fracture was lower than in those with an MPR of <80% (8.5% v 10.7%, p < 0.001, Relative Risk Reduction (RRR) 21%). In women who persisted with treatment (refill gap <30 days) the risk of fracture was also lower (7.7% v 10.3%, p < 0.001, RRR 29%).A nested case control study reported that 12 months persistence (refill gap <50% previous prescription (Rx) length) was associated with a 26% reduced risk of fracture (p < 0.05) and 24 months with a 32% reduced risk (p < 0.05). Four other studies, not specific to bisphosphonates, reported that compliance > or =12 months decreased fracture risk by approximately 25%. CONCLUSION: Sub optimal compliance and persistence with bisphosphonates is not providing the best possible protection against the risk of PMO fracture, however, more research is needed to delineate this relationship in clinical practice.

The effect of dosing frequency on compliance and persistence with bisphosphonate therapy in postmenopausal women: a comparison of studies in the United States, the United Kingdom, and France.

OBJECTIVES: The aim of this study was to determine the effect of dose frequency on compliance and persistence with bisphosphonate therapy in postmenopausal women and to compare findings from 3 different health care systems. METHODS: Three independently performed retrospective cohort analyses were performed using observational data sources. In the United States, bisphosphonate-naive postmenopausal women were identified from a database providing information on health plan prescription drug claims; in the United Kingdom and France, bisphosphonate-naive postmenopausal women were identified from a database of medical records supplied by general practice physicians. The women were grouped into 2 cohorts: those who were initiated on a weekly regimen of alendronate 70 mg or risedronate 35 mg and those initiated on a daily regimen of alendronate 5 or 10 mg or risedronate 5 mg. Compliance was measured in terms of the medication possession ratio (MPR), which was defined as the proportion of days in the 12-month follow-up period for which patients were covered by prescriptions for bisphosphonates. Persistence was measured as the number of days from the date of the index prescription to the last day of prescription coverage within the followup period. Women were classified as nonpersistent if the gap between prescriptions was > 30 days. RESULTS: The study included 2741 postmenopausal women with osteoporosis from the United States, 7567 from the United Kingdom, and 5332 from France. The mean (SD) age of the women was 73.0, 71.7, and 69.7 years in the 3 countries, respectively. The overall MPR was 61% in the United States, 74% in the United Kingdom, and 58% in France. In all 3 countries, women on a weekly regimen had a significantly greater MPR than women on a daily regimen (69% vs 58%, respectively, in the United States; 76% vs 64% in the United Kingdom; and 59% vs 53% in France; all, P < 0.001). Women on a weekly regimen of bisphosphonates persisted with treatment significantly longer than women on a daily regimen (227 vs 185 days, respectively, in the United States; 249 vs 208 in the United Kingdom; and 179 vs 155 in France; all, P < 0.001). A significantly greater proportion of the women on a weekly regimen persisted with treatment for 12 months compared with those on a daily regimen (44% vs 32%, respectively, in the United States; 52% vs 40% in the United Kingdom; and 51% vs 44% in France; all, P < 0.001). CONCLUSIONS: In all 3 countries, postmenopausal women prescribed a weekly regimen of bisphosphonates had significantly greater rates of compliance than women prescribed a daily regimen, and they persisted longer with treatment. However, compliance and persistence rates were suboptimal for both regimens.

The impact of dosing frequency on compliance and persistence with bisphosphonates among postmenopausal women in the UK: evidence from three databases.

BACKGROUND: Bisphosphonates are currently among the most effective therapies for the treatment of osteoporosis and provide one of the mainstays of treatment in the UK. However studies in several countries have all reported sub-optimal compliance and persistence with treatment. OBJECTIVE: To examine the impact of dosing frequency on compliance and persistence with bisphosphonates in the UK. METHODS: Three UK General Practitioner sourced databases, the General Practice Research Database (GPRD), IMS Disease Analyzer (MEDIPLUS) and the Doctors Independent Network Database (DIN-LINK) were used to identify bisphosphonate naïve postmenopausal women. In each of the three retrospective analyses women were grouped into weekly or daily cohorts and followed for 12 months from an initial prescription. Compliance was measured as a Medication Possession Ratio (MPR), defined as the proportion of days for which patients had prescription coverage. Persistence was measured as the number of continuous days of treatment from the initial prescription to the end of the last prescription issued in the follow-up period. RESULTS: GPRD, MEDIPLUS and DIN-LINK provided access to 7567, 5962 and 1801 women, respectively. All three analyses consistently demonstrated that those on weekly regimens had a higher MPR than those on daily regimens (GPRD 76.2%, CI(95%,) 75.4-77.0 vs. 63.5%, CI(95%) 61.2-65.8, MEDIPLUS 70.3%, CI(95%) 69.3-71.2 vs. 56.3%, CI(95%) 53.8-58.9, DIN-LINK 59.5%, CI(95%) 59.4-59.6 vs. 46.3%, CI(95%) 45.9-46.7) (p < 0.0001) and persisted longer with treatment (GPRD 249, CI(95%) 246-253 vs. 208, CI(95%) 199-217, MEDIPLUS 228, CI(95%) 224-231 vs. 186, CI(95%,) 176-196, DIN-LINK 235, CI(95%) 234-236 vs. 189, CI(95%) 187-191) days respectively), (p < 0.0001). CONCLUSIONS: Although this study only provided an indirect measure of medication usage, it demonstrated that a less frequent dosing regimen significantly improved levels of both compliance and persistence; however, even on weekly regimens bisphosphonate usage remains sub-optimal thereby reducing the clinical benefits.

Management of ischaemic stricture at a gastro-jejunostomy by self-expanding metallic stent insertion.

This report details the use of a self-expanding metallic stent (SEMS) in the relief of an ischaemic stricture at a gastro-jejunostomy in a patient who was unfit for surgical intervention. Good initial results are reported, along with satisfactory long-term follow-up. A brief discussion of the current relevant literature is also included.

Percutaneous peritoneal drainage for intraperitoneal bladder perforations during transurethral resection of bladder tumors.

PURPOSE: To demonstrate the safety and efficacy of percutaneous drainage of the peritoneal cavity using an 8F pigtail catheter placed under ultrasound guidance in cases of intraperitoneal perforation of the bladder as a result of transurethral resection of a bladder tumor (TURBT). PATIENTS AND METHODS: Three patients undergoing TURBT had inadvertent but significant intraperitoneal perforations of the bladder. All patients developed signs and symptoms of peritonism despite large catheters draining the bladder. An 8F pigtail catheter (Boston Scientific, Watertown, MD, USA) was inserted percutaneously under ultrasound guidance with local anesthetic infiltration. RESULTS: All three patients made a good recovery without needing a laparotomy. Cystograms a week later confirmed an intact bladder. Clinical review revealed no sequelae as a result of the perforation or its treatment. CONCLUSION: Percutaneous drainage of the abdomen in patients with intraperitoneal perforation of the bladder during TURBT is a safe alternative to laparotomy.

Embryology and adult urology - Not always mutually exclusive: A case report on true hermaphroditism at an adult urology clinic.

True hermaphrodite (TH) is one of the rarest varieties of disorders of sexual differentiation. Most patients present early in the life and are managed by pediatricians. We present a rare case of an adult TH which was first diagnosed by a urologist. We discuss the pathology of TH and its clinical relevance. Knowledge and awareness of embryology are vital to all specialties.