DOCSLIB.ORG

Cost of Physician Burnout Estimated at $4.6 Billion a Year

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Cost of Physician Burnout Estimated at $4.6 Billion a Year MDEDGE.COM/GIHEPNEWS VOL. 13 NO. 7 JULY 2019 ® Cost of physician News from burnout estimated at in this issue $4.6 billion a year INSIDE FROM THE AGA BY RICHARD FRANKI look at the system-wide AN JOURNALS C MDedge News costs of burnout, “provides INNU tools to evaluate the eco- Tofacitinib upped K hysician burnout nomic dimension of this herpes zoster risk AMI . J The higher daily doses R costs the U.S. health problem,” wrote Shasha D Pcare system approxi- Han, MS, of the National were at issue. • 8 mately $4.6 billion a year University of Singapore OURTESY NEWS FROM THE AGA C in physician turnover and and her associates in An- Dr. Jami Kinnucan and the AGA workgroup focused on gaps in IBD reduced productivity, ac- nals of Internal Medicine. AGA’s annual award care related to inflammatory issues, mental health, and nutrition. cording to the results of a Individual burnout-at- winners honored cost-consequence analysis. tributable costs were Reception at DDW In 2015, the burnout- higher for physicians in recognized AGA’s best. • 10 AGA introduces attributable cost per the younger age group physician was $7,600 (less than 55 years) in all LIVER DISEASE – an estimate occupying three specialty categories: AGA Clinical Practice pathway to navigate the conservative mid- $7,100 versus $5,900 for Update dle ground between the those aged at least 55 Coagulation management IBD care $3,700 and $11,000 ex- years among primary care in cirrhosis. • 22 tremes produced by the physicians, $10,800 versus BY HEIDI SPLETE of or diagnosed with IBD study’s mathematical $9,100 for surgical spe- UPPER GI TRACT MDedge News and provide direction on ini- model. cialists, and $7,800 versus Coffee, tea, and soda tiating appropriate patient “Traditionally, the case $6,100 for other special- increase GERD risk nflammatory bowel dis- referrals,” wrote lead author for ameliorating physi- ists, the investigators re- Caffeination did not seem ease (IBD) treatment re- Jami Kinnucan, MD, of the cian burnout has been ported. to matter. • 25 Imains a challenge in part University of Michigan, Ann made primarily on ethi- The mathematical model because care is often frag- Arbor, and members of the cal grounds.” This study, used in the study focused mented among providers in AGA workgroup. believed to be the first to See Burnout · page 28 different specialties, accord- In particular, the pathway ing to the American Gastro- focuses on gaps in IBD care enterological Association. To related to inflammatory FDA warns about fecal microbiota address the need for provid- issues, mental health, and er coordination, the AGA has nutrition. The work group issued a new referral path- included not only gastroen- for transplantation way for IBD care, published terologists, but also a prima- in Gastroenterology. ry care physician, mental/ BY DOUG BRUNK microbiota for transplanta- which was issued on June “The goal of this path- behavioral health specialist, MDedge News tion (FMT) and the risk of 13, 2019, the agency be- way is to offer guidance to registered dietitian/nutri- serious adverse reactions came aware of two im- primary care, emergency tionist, critical care spe- fficials at the Food and because of transmission of munocompromised adult department, and gastroen- cialist, nurse practitioner, ODrug Administration multidrug-resistant organ- patients who received terology providers, by help- physician group representa- have issued a safety alert isms (MDROs). investigational FMT and ing identify patients at risk See IBD · page 15 regarding the use of fecal According to the alert, See Microbiota · page 15 2019 James W. Freston Conference Food at the intersection of gut health and disease Rosemont, IL 60018 IL Rosemont, AUG. 9 & 10, 2019 | PALMER HOUSE | CHICAGO, ILLINOIS Lebanon Jct. KY Jct. Lebanon Suite 280 Suite Permit No. 384 No. Permit PAID freston.gastro.org 10255 W Higgins Road, Road, Higgins W 10255 Register today at . U.S. Postage U.S. EDU19-91 Presorted Standard Presorted CHANGE SERVICE REQUESTED SERVICE CHANGE GI & Hepatology News Hepatology & GI 2 NEWS JULY 2019 • GI & HEPATOLOGY NEWS LETTER FROM THE EDITOR: Wellness seminars won’t fix burnout urnout” has been defined ience of our physicians or sending to sacrifice more time and energy must be realistic as long-term, unresolvable us to wellness seminars. That ap- and sit in front of a computer screen. and legal pro- “Bjob stress that leads to proach is a direct blame-the-victim Salvation of our health care sys- tections need exhaustion, depression, and in some paradigm. Physicians are burned out tem will not come from mass retire- strengthening. tragic circumstances, suicide. One because of the constant assault on ments (although that is happening), The politics of of our lead articles this month con- the core reasons we entered med- concierge practices, part-time status, health care has cerns an attempt to place a financial icine – to help people (this assault or other individual responses to this focused on funds DR. ALLEN cost on physician burnout. More has been termed “moral injury”). crisis. We will need a fundamen- flow and ideolo- important, I think, is the toll burnout BPAs (best practice alerts), coding tal reorganization of our practice, gy. We need a stronger voice that ar- takes on an individual, their family, requirements, inbox demands, pri- where we (physicians) reduce our ticulates the daily microaggressions and their patients. In my role as or authorizations (see the practice work to activities for which we that we each endure as we try to live Chief Clinical Officer of the Univer- management section of this issue), trained combined with a shift of Oslerian physician ideals. sity of Michigan Medical Group (our electronic-order entry, and most nonphysician work to others, better faculty and other clinical providers), other practice enhancement tools technology, virtual visits, and ancil- John I. Allen, MD, MBA, AGAF I struggle to balance productivity rely on the willingness of physicians lary personnel. Patient expectations Editor in Chief demands with the increasing dam- age such demands are doing to our clinicians. Few primary care physi- cians at Michigan Medicine work as Quick quiz full-time clinicians (defined as 32 hours patient-facing time per week for 46 weeks). Almost all request Q1: A 70-year-old male presents E. Placement of G tube over-the-counter NSAIDs, breast part-time status if they do not have with progressive dysphagia over cancer (20 years ago treated with protected, grant-funded time. They the past 4 months and 30-pound Q2: A 63-year-old woman is ad- lumpectomy and local radiation); simply cannot keep up with the weight loss. A barium swallow mitted with abdominal pain and and migraines for which she takes documentation required in our elec- demonstrates a dilated esophagus iron deficiency anemia. She re- sumatriptan once or twice a month. tronic health record, combined with with a bird’s beak appearance. ports long-standing anemia and a our “patient-friendly” access via negative work-up in the past year Which medication puts her at the the electronic portal. One-third of What is the next best step? including an upper endoscopy, highest risk for peptic ulcer disease? the private practice group I helped A. Referral for per-oral endoscopic colonoscopy, and video capsule A. Iron build was part-time when I left in myotomy endoscopy. She was started on iron B. Sumatriptan 2012, and it is not unusual to hear B. High-resolution esophageal infusions with a modest improve- C. Alendronate complaints about burnout from my manometry ment in her anemia. Her other med- D. Tamoxifen ex-partners. C. Calcium channel blocker ical history includes osteoporosis; Let’s be clear, burnout is not going D. EGD osteoarthritis, for which she takes The answers are on page 26. to be solved by increasing the resil- EDITOR IN CHIEF, GI & HEPATOLOGY NEWS GI & HEPATOLOGY NEWS is the official newspaper of the American FRONTLINE MEDICAL COMMUNICATIONS SOCIETY PARTNERS John I. Allen, MD, MBA, AGAF Gastroenterological Association (AGA) Institute and provides the gastroenterologist VP/Group Publisher; Director, FMC Society Partners Mark Branca EDITOR IN CHIEF, THE NEW GASTROENTEROLOGIST with timely and relevant news and commentary about clinical developments Editor in Chief Mary Jo M. Dales Bryson Katona, MD, PhD and about the impact of health care policy. Content for GI & HEPATOLOGY NEWS is developed through a partnership of the newspaper’s medical board of editors Executive Editors Denise Fulton, Kathy Scarbeck ASSOCIATE EDITORS Megan A. Adams, MD, JD, MSc (Editor in Chief and Associate Editors), Frontline Medical Communications Inc. Editor Lora T. McGlade Ziad Gellad, MD, MPH, AGAF and the AGA Institute Staff. “News from the AGA” is provided exclusively by the Creative Director Louise A. Koenig AGA, AGA Institute, and AGA Research Foundation. All content is reviewed by the Kim L. Isaacs, MD, PhD, AGAF Director, Production/Manufacturing Rebecca Slebodnik Gyanprakash A. Ketwaroo, MD, MSc medical board of editors for accuracy, timeliness, and pertinence. To add clarity and context to important developments in the field, select content is reviewed by and National Account Manager Artie Krivopal, 973-290-8218, Larry R. Kosinski, MD, MBA, AGAF cell 973-202-5402, [email protected] Sonia S. Kupfer, MD commented on by external experts selected by the board of editors. Digital Account Manager Rey Valdivia, 973-206-8094, [email protected] Wajahat Mehal, MD, PhD The ideas and opinions expressed in GI & HEPATOLOGY NEWS do not necessarily Senior Director of Classified Sales Tim LaPella, 484-921-5001, reflect those of the AGA Institute or the Publisher. The AGA Institute and Frontline EDITORS EMERITUS [email protected] Colin W. Howden, MD, AGAF Medical Communications Inc. will not assume responsibility for damages, loss, Advertising Offices 7 Century Drive, Suite 302, Parsippany, Charles J.
Load more

Recommended publications
  • Hepatic Hydrothorax Without Apparent Ascites and Dyspnea - a Case Report
    Case Report DOI: 10.7860/JCDR/2018/37185.12181 I nternal Medicine Hepatic Hydrothorax without Apparent S ection Ascites and Dyspnea - A Case Report JING HE1, RASHA HAYKAL2, HONGCHUAN COVILLE3, JAYA PRAKASH GADIKOTA4, CHRISTOPHER BRAY5 ABSTRACT A 78-year-old female with a past medical history of alcoholic cirrhosis was hospitalised with recurrent lower gastrointestinal bleeding due to rectal ulcers. The ulcers were successfully treated with cautery and placement of clips. However, a recurrent large right-sided pleural effusion without apparent ascites and dyspnea were found incidentally during the hospitalisation. The initial fluid analysis was exudate based on Light’s criteria with high protein. The fluid analysis was repeated five days later, after rapid reaccumulation which revealed transudates. Other causes of pleural effusion like heart failure, renal failure or primary pulmonary diseases were excluded. Hepatic hydrothorax was considered and the patient was started with the treatment of Furosemide and Spironolactone. The atypical presentation of hepatic hydrothorax may disguise the diagnosis and delay the treatment. Therefore, for a patient with recurrent, unexplained unilateral pleural effusions, even with atypical fluid characterisation and in the absence of ascites, hepatic hydrothorax should still remain on the top differential with underlying cirrhosis to ensure optimal treatment. Keywords: Cirrhosis, Light criteria, Liver, Pleural effusion CASE REPORT Haemogram Levels Normal range A 78-year-old Caucasian female, with a past medical history of alcoholic cirrhosis, admitted for recurrent rectal bleeding secondary WBC 6.9 (4.5-11.0 thousands/mm3) to rectal ulcers and was successfully treated with cautery and Neutrophils % 78 H (50.0-75.0 %) placement of clips.
    [Show full text]
  • Section 8 Pulmonary Medicine
    SECTION 8 PULMONARY MEDICINE 336425_ST08_286-311.indd6425_ST08_286-311.indd 228686 111/7/121/7/12 111:411:41 AAMM CHAPTER 66 EVALUATION OF CHRONIC COUGH 1. EPIDEMIOLOGY • Nearly all adult cases of chronic cough in nonsmokers who are not taking an ACEI can be attributed to the “Pathologic Triad of Chronic Cough” (asthma, GERD, upper airway cough syndrome [UACS; previously known as postnasal drip syndrome]). • ACEI cough is idiosyncratic, occurrence is higher in female than males 2. PATHOPHYSIOLOGY • Afferent (sensory) limb: chemical or mechanical stimulation of receptors on pharynx, larynx, airways, external auditory meatus, esophagus stimulates vagus and superior laryngeal nerves • Receptors upregulated in chronic cough • CNS: cough center in nucleus tractus solitarius • Efferent (motor) limb: expiratory and bronchial muscle contraction against adducted vocal cords increases positive intrathoracic pressure 3. DEFINITION • Subacute cough lasts between 3 and 8 weeks • Chronic cough duration is at least 8 weeks 4. DIFFERENTIAL DIAGNOSIS • Respiratory tract infection (viral or bacterial) • Asthma • Upper airway cough syndrome (postnasal drip syndrome) • CHF • Pertussis • COPD • GERD • Bronchiectasis • Eosinophilic bronchitis • Pulmonary tuberculosis • Interstitial lung disease • Bronchogenic carcinoma • Medication-induced cough 5. EVALUATION AND TREATMENT OF THE COMMON CAUSES OF CHRONIC COUGH • Upper airway cough syndrome: rhinitis, sinusitis, or postnasal drip syndrome • Presentation: symptoms of rhinitis, frequent throat clearing, itchy
    [Show full text]
  • Hepatic Hydrothorax: an Updated Review on a Challenging Disease
    Lung (2019) 197:399–405 https://doi.org/10.1007/s00408-019-00231-6 REVIEW Hepatic Hydrothorax: An Updated Review on a Challenging Disease Toufc Chaaban1 · Nadim Kanj2 · Imad Bou Akl2 Received: 18 February 2019 / Accepted: 27 April 2019 / Published online: 25 May 2019 © Springer Science+Business Media, LLC, part of Springer Nature 2019 Abstract Hepatic hydrothorax is a challenging complication of cirrhosis related to portal hypertension with an incidence of 5–11% and occurs most commonly in patients with decompensated disease. Diagnosis is made through thoracentesis after exclud- ing other causes of transudative efusions. It presents with dyspnea on exertion and it is most commonly right sided. Patho- physiology is mainly related to the direct passage of fuid from the peritoneal cavity through diaphragmatic defects. In this updated literature review, we summarize the diagnosis, clinical presentation, epidemiology and pathophysiology of hepatic hydrothorax, then we discuss a common complication of hepatic hydrothorax, spontaneous bacterial pleuritis, and how to diagnose and treat this condition. Finally, we elaborate all treatment options including chest tube drainage, pleurodesis, surgical intervention, Transjugular Intrahepatic Portosystemic Shunt and the most recent evidence on indwelling pleural catheters, discussing the available data and concluding with management recommendations. Keywords Hepatic hydrothorax · Cirrhosis · Pleural efusion · Thoracentesis Introduction Defnition and Epidemiology Hepatic hydrothorax (HH) is one of the pulmonary com- Hepatic hydrothorax is defned as the accumulation of more plications of cirrhosis along with hepatopulmonary syn- than 500 ml, an arbitrarily chosen number, of transudative drome and portopulmonary hypertension. It shares common pleural efusion in a patient with portal hypertension after pathophysiological pathways with ascites secondary to por- excluding pulmonary, cardiac, renal and other etiologies [4].
    [Show full text]
  • Redalyc.COMUNICAÇÕES ORAIS
    Revista Portuguesa de Pneumología ISSN: 0873-2159 [email protected] Sociedade Portuguesa de Pneumologia Portugal COMUNICAÇÕES ORAIS Revista Portuguesa de Pneumología, vol. 23, núm. 3, noviembre, 2017 Sociedade Portuguesa de Pneumologia Lisboa, Portugal Disponível em: http://www.redalyc.org/articulo.oa?id=169753668001 Como citar este artigo Número completo Sistema de Informação Científica Mais artigos Rede de Revistas Científicas da América Latina, Caribe , Espanha e Portugal Home da revista no Redalyc Projeto acadêmico sem fins lucrativos desenvolvido no âmbito da iniciativa Acesso Aberto Document downloaded from http://www.elsevier.es, day 06/12/2017. This copy is for personal use. Any transmission of this document by any media or format is strictly prohibited. COMUNICAÇÕES ORAIS CO 001 CO 002 COPD EXACERBATIONS IN AN INTERNAL MEDICINE MORTALITY AFTER ACUTE EXACERBATION OF COPD WARD REQUIRING NONINVASIVE VENTILATION C Sousa, L Correia, A Barros, L Brazão, P Mendes, V Teixeira D Maia, D Silva, P Cravo, A Mineiro, J Cardoso Hospital Central do Funchal Serviço de Pneumologia do Hospital de Santa Marta, Centro Hospitalar de Lisboa Central Key-words: COPD, Hospital admissions, Follow-up, Management, Indicators Key-words: AECOPD, NIV, Mortality Introduction: Chronic obstructive pulmonary disease (COPD) Introduction: Acute COPD exacerbations (AECOPD) are serious is a major cause of morbidity and mortality. The occurrence of episodes in the natural history of the disease and are associ - acute exacerbations (AE) contributes to the gravity of the dis - ated with significant mortality. Noninvasive ventilation (NIV) is a ease. Many of these cases are admitted in an Internal Medicine well-established therapy in hypercapnic AECOPD.
    [Show full text]
  • Residency Essentials Full Curriculum Syllabus
    RESIDENCY ESSENTIALS FULL CURRICULUM SYLLABUS Please review your topic area to ensure all required sections are included in your module. You can also use this document to review the surrounding topics/sections to ensure fluidity. Click on the topic below to jump to that page. Clinical Topics • Gastrointestinal • Genitourinary • Men’s Health • Neurological • Oncology • Pain Management • Pediatrics • Vascular Arterial • Vascular Venous • Women’s Health Requisite Knowledge • Systems • Business and Law • Physician Wellness and Development • Research and Statistics Fundamental • Clinical Medicine • Intensive Care Medicine • Image-guided Interventions • Imaging and Anatomy Last revised: November 4, 2019 Gastrointestinal 1. Portal hypertension a) Pathophysiology (1) definition and normal pressures and gradients, MELD score (2) Prehepatic (a) Portal, SMV or Splenic (i) thrombosis (ii) stenosis (b) Isolated mesenteric venous hypertension (c) Arterioportal fistula (3) Sinusoidal (intrahepatic) (a) Cirrhosis (i) ETOH (ii) Non-alcoholic fatty liver disease (iii) Autoimmune (iv) Viral Hepatitis (v) Hemochromatosis (vi) Wilson's disease (b) Primary sclerosing cholangitis (c) Primary biliary cirrhosis (d) Schistosomiasis (e) Infiltrative liver disease (f) Drug/Toxin/Chemotherapy induced chronic liver disease (4) Post hepatic (a) Budd Chiari (Primary secondary) (b) IVC or cardiac etiology (5) Ectopic perianastomotic and stomal varices (6) Splenorenal shunt (7) Congenital portosystemic shunt (Abernethy malformation) b) Measuring portal pressure (1) Direct
    [Show full text]
  • A Phase 3 Multicenter Study of the Long-Term Safety and Tolerability Of
    A Phase 3 Multicenter Study of the Long-term Safety and Tolerability of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults who Have an Inadequate Response to Antidepressant Therapy (the FORWARD-2 Study) Unique Protocol ID: ALK5461-208 NCT Number: NCT02141399 EudraCT Number: 2014-000380-41 Date of Statistical Analysis 15 September 2017 Plan: STATISTICAL ANALYSIS PLAN PHASE III ALK5461-208 A Phase 3 Multicenter Study of the Long-term Safety and Study Title: Tolerability of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults who Have an Inadequate Response to Antidepressant Therapy (the FORWARD-2 Study) Document Status: Final Document Date: 15 September 2017 Based on: Study protocol amendment 3 (dated 03 March 2016) Study protocol amendment 2 (dated 12 May 2015) Study protocol amendment 1 (dated 17 April 2014) Original study protocol (dated 16 December 2013) Sponsor: Alkermes, Inc. 852 Winter Street Waltham, MA 02451 USA CONFIDENTIAL Information and data in this document contain trade secrets and privileged or confidential information, which is the property of Alkermes, Inc. No person is authorized to make it public without the written permission of Alkermes, Inc. These restrictions or disclosures will apply equally to all future information supplied to you that is indicated as privileged or confidential. This study is being conducted in compliance with good clinical practice, including the archiving of essential documents. Alkermes, Inc. ALKS 5461 CONFIDENTIAL SAP-ALK5461-208 TABLE OF CONTENTS LIST OF ABBREVIATIONS ..........................................................................................................5 1. INTRODUCTION ........................................................................................................7 1.1. Study Objectives ...........................................................................................................7 1.2. Summary of the Study Design and Schedule of Assessments ......................................7 1.3.
    [Show full text]
  • Patients with Cirrhosis During the COVID-19 Pandemic: Current Evidence and Future Perspectives Su HY, Hsu YC
    ISSN 2307-8960 (online) World Journal of Clinical Cases World J Clin Cases 2021 May 6; 9(13): 2951-3226 Published by Baishideng Publishing Group Inc World Journal of W J C C Clinical Cases Contents Thrice Monthly Volume 9 Number 13 May 6, 2021 REVIEW 2951 Patients with cirrhosis during the COVID-19 pandemic: Current evidence and future perspectives Su HY, Hsu YC MINIREVIEWS 2969 Immunotherapy for pancreatic cancer Yoon JH, Jung YJ, Moon SH ORIGINAL ARTICLE Retrospective Study 2983 Scrotal septal flap and two-stage operation for complex hypospadias: A retrospective study Chen S, Yang Z, Ma N, Wang WX, Xu LS, Liu QY, Li YQ 2994 Clinical diagnosis of severe COVID-19: A derivation and validation of a prediction rule Tang M, Yu XX, Huang J, Gao JL, Cen FL, Xiao Q, Fu SZ, Yang Y, Xiong B, Pan YJ, Liu YX, Feng YW, Li JX, Liu Y 3008 Prognostic value of hemodynamic indices in patients with sepsis after fluid resuscitation Xu HP, Zhuo XA, Yao JJ, Wu DY, Wang X, He P, Ouyang YH Observational Study 3014 Updated Kimura-Takemoto classification of atrophic gastritis Kotelevets SM, Chekh SA, Chukov SZ SYSTEMATIC REVIEWS 3024 Systematic review and meta-analysis of the impact of deviations from a clinical pathway on outcomes following pancreatoduodenectomy Karunakaran M, Jonnada PK, Barreto SG META-ANALYSIS 3038 Early vs late cholecystectomy in mild gall stone pancreatitis: An updated meta-analysis and review of literature Walayat S, Baig M, Puli SR CASE REPORT 3048 Effects of intravascular laser phototherapy on delayed neurological sequelae after carbon
    [Show full text]
  • Clinical Insights for Hepatology and Liver Transplant Providers During the Covid-19 Pandemic
    CLINICAL INSIGHTS FOR HEPATOLOGY AND LIVER TRANSPLANT PROVIDERS DURING THE COVID-19 PANDEMIC Disclaimer This document represents the collective opinion of its authors and approval of the AASLD Governing Board as of the date of publication. Its use is voluntary, and it is presented primarily for the purpose of providing information to hepatology and liver transplant care providers. This document is not a practice guideline and has not been subject to the methodical rigor of a practice guideline. There has not been a systematic evidence review as defined by the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine (formerly the Institute of Medicine), nor is the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach utilized. This document does not define a standard of practice or a standard of care. It should not be considered as inclusive of all proper treatments or methods of care, nor is it intended to substitute for the independent professional judgment of the treating provider. Hospitals, clinics and private practices should take into account local standards, practices and environment. Overview Coronavirus disease 2019 (COVID-19), the illness caused by the SARS-CoV-2 virus, is rapidly spreading throughout the world.1 Hospitals and healthcare providers across the United States are preparing for the anticipated surge in critically ill patients but few are wholly equipped to manage this new disease. Nonetheless, we all must do our part to prepare our patients, clinics, and hospitals for the drastic changes necessary to mitigate the spread of SARS-CoV-2 or we risk overwhelming the capacity of our healthcare system.2 In addition, we must continue to manage the care of our patients with liver disease and our liver transplant recipients where unique logistical and pharmacological issues will arise.
    [Show full text]
  • Statistical Analysis Plan (Version 4)
    CONFIDENTIAL VTL-308 STATISTICAL ANALYSIS PLAN (VERSION 4) Title A Randomized, Open-label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD® in Subjects with Alcohol-Induced Liver Decompensation (AILD) Sponsor Vital Therapies, Incorporated 15010 Avenue of Science, Suite 200 San Diego, CA 92128 Statistician Ciani Sparks, MS Author Robert A. Ashley, MA Version 4 24 August 2018 Version 3 03 November 2017 Version 2 20 November 2015 Version 1 12 October 2015 This document is the property of Vital Therapies Inc. (VTL) and contains information that is of a confidential, trade secret and/or proprietary nature. It is intended for use by Vital Therapies and its designees, and no portion may be photocopied, disclosed, or transmitted to any unauthorized person without the prior written approval of VTL. The holder is bound by the terms of confidentiality contained in the agreement with VTL pursuant to which the holder has been provided access to this document and is responsible for the safekeeping and return of the document to VTL upon request. CONFIDENTIAL Vital Therapies, Inc. ELAD® System VTL-308 Statistical Analysis Plan (Version 4) TABLE OF CONTENTS 1 STUDY OBJECTIVES AND SAMPLE SIZE RATIONALE ..................................................5 1.1 Introduction ....................................................................................................................5 1.2 Analysis Objectives .......................................................................................................5 1.2.1 Primary
    [Show full text]
  • Hepatic Hydrothorax
    Hepatic Hydrothorax. , 2018; 17 (1): 33-46 33 CONCISE REVIEW January-February, Vol. 17 No. 1, 2018: 33-46 The Official Journal of the Mexican Association of Hepatology, the Latin-American Association for Study of the Liver and the Canadian Association for the Study of the Liver Hepatic Hydrothorax Yong Lv,* Guohong Han,* Daiming Fan** * Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an 710032, China. ** State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an 710032, China. ABSTRACT Hepatic hydrothorax (HH) is a pleural effusion that develops in a patient with cirrhosis and portal hypertension in the absence of car- diopulmonary disease. Although the development of HH remains incompletely understood, the most acceptable explanation is that the pleural effusion is a result of a direct passage of ascitic fluid into the pleural cavity through a defect in the diaphragm due to the raised abdominal pressure and the negative pressure within the pleural space. Patients with HH can be asymptomatic or present with pulmonary symptoms such as shortness of breath, cough, hypoxemia, or respiratory failure associated with large pleural effusions. The diagnosis is established clinically by finding a serous transudate after exclusion of cardiopulmonary disease and is confirmed by radionuclide imaging demonstrating communication between the peritoneal and pleural spaces when necessary. Spontaneous bacteri- al empyema is serious complication of HH, which manifest by increased pleural fluid neutrophils or a positive bacterial culture and will require antibiotic therapy.
    [Show full text]
  • Randomised Clinical Trial: Palliative Long‐Term Abdominal Drains Vs
    Received: 21 January 2020 | First decision: 12 February 2020 | Accepted: 28 April 2020 DOI: 10.1111/apt.15802 Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis Lucia Macken1 | Stephen Bremner1 | Heather Gage2 | Morro Touray2 | Peter Williams2 | David Crook1 | Louise Mason1* | Debbie Lambert1 | Catherine J. Evans1,3 | Max Cooper1 | Jean Timeyin1 | Shani Steer1 | Mark Austin1 | Nick Parnell1 | Sam J. Thomson4 | David Sheridan5 | Mark Wright6 | Peter Isaacs7 | Ahmed Hashim1 | Sumita Verma1 1Brighton, UK Summary 2Guildford, UK 3 London, UK Background: Palliative care remains suboptimal in end-stage liver disease. 4Worthing, UK Aims: To inform a definitive study, we assessed palliative long-term abdominal drains 5Plymouth, UK in end-stage liver disease to determine recruitment, attrition, safety/potential effec- 6 Southampton, UK tiveness, questionnaires/interview uptake/completion and make a preliminary cost 7 Blackpool, UK comparison. Correspondence Methods: A 12-week feasibility nonblinded randomised controlled trial comparing Sumita Verma, Brighton and Sussex Medical large-volume paracentesis vs long-term abdominal drains in refractory ascites due to School, Main Teaching Building, Room 2.17, North South Road, Falmer, Brighton BN1 end-stage liver disease with fortnightly home visits for clinical/questionnaire-based 9PX, UK. assessments. Study success criteria were attrition not >50%, <10% long-term ab- Email: [email protected] dominal drain removal due to complications, the long-term abdominal drain group Funding information to spend <50% ascites-related study time in hospital vs large-volume paracentesis LMa is funded by the National Institute for Health Research and Kent Surrey group and 80% questionnaire/interview uptake/completion.
    [Show full text]
  • To Access the Fellowship Curriculum Guide
    Curriculum 1.The program must provide a description of the skills and competencies the fellow will be able to demonstrate at the conclusion of the program to fellows and faculty at least annually, in either written or electronic form. 2. ACGME Competencies (See summary by Mullon, CHEST 2017; 151(5):1114-1121) Interventional pulmonology involves the care patients with both non-malignant and malignant airway, pleural, mediastinal and parenchymal lung diseases. Accredited training programs in interventional pulmonology must provide a broad exposure to patients suffering from both malignant and non-malignant diseases of the thorax. The program must integrate the following ACGME competencies into the curriculum: 2.a) Medical Knowledge Fellows must demonstrate in depth knowledge of IP-related disease processes as well as established and evolving biomedical, clinical, epidemiological and social-behavioral sciences, and demonstrate the ability to apply this knowledge to patient care. A didactic lecture series is required with a minimum of once monthly lectures delivered by faculty. Fellows must: 2.a).(1) demonstrate knowledge of the scientific method of problem solving and evidence- based decision making. This must include knowledge of study design, research ethics, and medical biostatistics. 2.a).(2) demonstrate a knowledge of indications, contraindications, limitations, complications, techniques, and interpretation of results of those diagnostic and therapeutic procedures integral to the discipline, including the appropriate indication for
    [Show full text]