50 Studies Every Internist Should Know
50 STUDIES EVERY DOCTOR SHOULD KNOW Published and Forthcoming Books in the 50 Studies Every Doctor Should Know Series 50 Studies Every Doctor Should Know: The Key Studies That Form the Foundation of Evidence Based Medicine, Revised Edition Michael E. Hochman 50 Studies Every Internist Should Know Edited by Kristopher Swiger, Joshua R. Thomas, Michael E. Hochman, and Steven D. Hochman 50 Studies Every Neurologist Should Know Edited by David Y. Hwang and David M. Greer 50 Studies Every Surgeon Should Know Edited by SreyRam Kuy and Rachel J. Kwon 50 Studies Every Pediatrician Should Know Edited by Ashaunta Tumblin, Nina L. Shapiro, Stephen C. Aronoff, Jeremiah Davis, and Michael Levy 50 Imaging Studies Every Doctor Should Know Christoph Lee 50 Studies Every Anesthesiologist Should Know Anita Gupta Interested in writing or proposing a book in the series? Email:
[email protected]
50 Studies Every Internist Should Know EDITED BY
K ristopher J. Swiger , MD Resident Physician, Internal Medicine The Johns Hopkins Hospital Baltimore, Maryland
Joshua R. Thomas, MD, MPH Cardiology Fellow, Pediatrics and Adult Congenital HD Nationwide Children’s Hospital The Ohio State University Columbus, Ohio
M ichael E. Hochman, MD, MPH Medical Director for Innovation AltaMed Health Services Los Angeles, California
Steven D. Hochman, MPH Medical Student Keck School of Medicine of the University of Southern California Los Angeles, California SERIES EDITOR:
M ichael E. Hochman, MD, MPH
1
1 Oxford University Press is a department of the University of Oxford. It furthers the University’s objective of excellence in research, scholarship, and education by publishing worldwide. Oxford New York Auckland Cape Town Dar es Salaam Hong Kong Karachi Kuala Lumpur Madrid Melbourne Mexico City Nairobi New Delhi Shanghai Taipei Toronto With offices in Argentina Austria Brazil Chile Czech Republic France Greece Guatemala Hungary Italy Japan Poland Portugal Singapore South Korea Switzerland Thailand Turkey Ukraine Vietnam Oxford is a registered trademark of Oxford University Press in the UK and certain other countries. Published in the United States of America by Oxford University Press 198 Madison Avenue, New York, NY 10016
© Oxford University Press 2015 All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, without the prior permission in writing of Oxford University Press, or as expressly permitted by law, by license, or under terms agreed with the appropriate reproduction rights organization. Inquiries concerning reproduction outside the scope of the above should be sent to the Rights Department, Oxford University Press, at the address above. You must not circulate this work in any other form and you must impose this same condition on any acquirer. Library of Congress Cataloging-in-Publication Data 50 studies every internist should know / edited by Kristopher J. Swiger, Joshua R. Thomas, Michael E. Hochman, Steven D. Hochman. p. ; cm. — (50 studies every doctor should know) 50 studies every internist should know Includes bibliographical references and index. ISBN 978–0–19–934993–7 (alk. paper) I. Swiger, Kristopher, editor. II. Thomas, Joshua R., editor. III. Hochman, Michael E., editor. IV. Hochman, Steven, editor. V. Title: 50 studies every internist should know. VI. Series: 50 studies every doctor should know (Series) [DNLM: 1. Internal Medicine—methods. 2. Evidence-Based Medicine. 3. Preventive Medicine—methods. WB 115] RC46 616—dc23 2014043394 This material is not intended to be, and should not be considered, a substitute for medical or other professional advice. Treatment for the conditions described in this material is highly dependent on the individual circumstances. And while this material is designed to offer accurate information with respect to the subject matter covered and to be current as of the time it was written, research and knowledge about medical and health issues is constantly evolving and dose schedules for medications are being revised continually, with new side effects recognized and accounted for regularly. Readers must therefore always check the product information and clinical procedures with the most up-to-date published product information and data sheets provided by the manufacturers and the most recent codes of conduct and safety regulation. The publisher and the authors make no representations or warranties to readers, express or implied, as to the accuracy or completeness of this material. Without limiting the foregoing, the publisher and the authors make no representations or warranties as to the accuracy or efficacy of the drug dosages mentioned in the material. The authors and the publisher do not accept, and expressly disclaim, any responsibility for any liability, loss, or risk that may be claimed or incurred as a consequence of the use and/or application of any of the contents of this material. 9 8 7 6 5 4 3 2 1 Printed in the United States of America on acid-free paper
To Shannon, the reason for everything I do. —Kristopher J. Swiger, MD To my wife, Ive Caroline, and children, Jeffrey, Daniel, and Jacob, and to my parents, Jeff and Sharolyn Thomas. Thanks for all of your love and support. —Joshua R. Thomas, MD, MPH To the Cambridge Health Alliance Internal Medicine Residency Program, where I learned to practice thoughtful, patient-focused, evidence-based medicine. —Michael E. Hochman, MD, MPH To Mom and Hannah.
—Steven D. Hochman, MPH
CONTENTS
Preface xiii Acknowledgments xv Contributors xix SECTION 1 Preventive Medicine 1. Preventing Diabetes: The Diabetes Prevention Program 3 Michael E. Hochman 2. Dietary Approaches to Stop Hypertension (DASH) 9 Steven D. Hochman 3. Aspirin for the Primary Prevention of Cardiovascular Disease: The Physicians’ Health Study and the Women’s Health Study 15 Michael E. Hochman 4. Postmenopausal Hormone Therapy: The Women’s Health Initiative (WHI) 21 Michael E. Hochman 5. The Cochrane Review of Screening Mammography 27 Michael E. Hochman 6. The European Randomized Study of Screening for Prostate Cancer (ERSPC) 33 Michael E. Hochman 7. Screening for Lung Cancer with Low-Dose Computed Tomography versus Chest Radiography: The National Lung Screening Trial (NLST) 39 Kathryn White
viii
Contents
SECTION 2 Endocrinology 8. Treating Elevated Blood Sugar Levels in Patients with Type 2 Diabetes: The United Kingdom Prospective Diabetes Study (UKPDS) 47 Michael E. Hochman 9. Intensive versus Conservative Blood Sugar Control in Patients with Type 2 Diabetes: The ACCORD Trial 55 Michael E. Hochman 10. Intensive versus Conventional Glycemic Control in Type 1 Diabetes Mellitus: The DCCT Trial 61 Thomas Kriley 11. Intensive versus Conservative Blood Pressure Control in Patients with Type 2 Diabetes: The ACCORD-BP Trial 67 Steven D. Hochman SECTION 3 Hematology and Oncology 12. Choice of Anticoagulant for Prevention of Recurrent Venous Thromboembolism in Patients with Cancer: The CLOT Trial 75 Laalitha Surapaneni 13. Vena Cava Filters in the Prevention of Pulmonary Embolism in Patients with Proximal Deep Vein Thrombosis 81 Laalitha Surapaneni 14. Phase I Study of Imatinib (STI571) in Patients with Chronic Myeloid Leukemia 87 Joshua R. Thomas SECTION 4 Musculoskeletal Diseases 15. Magnetic Resonance Imaging for Low Back Pain 95 Michael E. Hochman 16. Early Therapy for Rheumatoid Arthritis: The TICORA Study 101 Kathryn White
Contents
SECTION 5 Nephrology 17. Revascularization versus Medical Therapy for Renal Artery Stenosis: The ASTRAL Trial 109 Steven D. Hochman 18. Correcting Anemia in Chronic Kidney Disease: The CHOIR Trial 115 Thomas Kriley 19. Early versus Late Initiation of Dialysis: The IDEAL Study 121 Michael E. Hochman SECTION 6 Gastroenterology 20. Use of IV Albumin in Patients with Cirrhosis and Spontaneous Bacterial Peritonitis 129 Steven D. Hochman 21. Early Use of Transjugular Intrahepatic Portosystemic Shunt (TIPS) in Patients with Cirrhosis and Variceal Bleeding 135 Adel Boueiz SECTION 7 Infectious Diseases 22. Methicillin-Resistant S. aureus Infections among Patients in the Emergency Department 143 Laalitha Surapaneni 23. Antibiotic Therapy in Exacerbations of Chronic Obstructive Pulmonary Disease 149 Kristopher J. Swiger 2 4. Early versus Delayed Antiretroviral Therapy for Patients with HIV: The NA-ACCORD Study 155 Michael E. Hochman SECTION 8 Cardiology 25. Statins in Healthy Patients with an Elevated C-Reactive Protein: The JUPITER Trial 163 Michael E. Hochman 26. The Scandinavian Simvastatin Survival Study (4S) 169 William Butron
ix
Contents
x
27. Choosing First-Line Therapy for Hypertension: The ALLHAT Trial 175 Michael E. Hochman 28. Rate Control versus Rhythm Control for Atrial Fibrillation: The AFFIRM Trial 181 Michael E. Hochman 29. Initial Treatment of Stable Coronary Artery Disease: The COURAGE Trial 187 Michael E. Hochman 30. Early Invasive versus Conservative Management for Unstable Angina or Non-ST-Elevation Myocardial Infarction: The RITA 3 Trial 193 Lavanya Kondapalli 31. Prophylactic Defibrillator Implantation in Patients with Low Ejection Fraction following Myocardial Infarction: The MADIT II Trial 199 Joshua R. Thomas 32. Captopril in Patients with Left Ventricular Dysfunction after Myocardial Infarction: The SAVE Trial 205 Vimal Ramjee 33. Spironolactone in Advanced Heart Failure: The RALES Trial 211 Vimal Ramjee 34. The African American Heart Failure Trial (A-HeFT) 217 Michael E. Hochman 35. Intra-Aortic Balloon Support for Myocardial Infarction with Cardiogenic Shock: The IABP-SHOCK II Trial 223 Steven D. Hochman SECTION 9 Pulmonary and Critical Care Medicine 36. Intensive versus Conventional Glucose Control in Critically Ill Patients: The NICE-SUGAR Study 231 Kristopher J. Swiger 37. Red Cell Transfusion in Critically Ill Patients: The TRICC Trial 237 Michael E. Hochman
Contents
38. Noninvasive Ventilation for Acute Exacerbations of Chronic Obstructive Pulmonary Disease 243 Adel Boueiz 39. Low Tidal Volume Ventilation in Acute Respiratory Distress Syndrome/Acute Lung Injury: The ARDSNet Trial 249 Kristopher J. Swiger 4 0. Comparison of Routine versus On-Demand Chest Radiographs in Mechanically Ventilated Adults in the Intensive Care Unit 255 Adel Boueiz 41. Early Goal-Directed Therapy in Sepsis 261 Michael E. Hochman 42. Dopamine versus Norepinephrine in the Treatment of Shock 267 Adel Boueiz 43. Daily Interruption of Sedative Infusions in Critically Ill Patients Undergoing Mechanical Ventilation 271 Laalitha Surapaneni 4 4. A Comparison of Four Methods of Weaning Patients from Mechanical Ventilation 277 Laalitha Surapaneni SECTION 10 Geriatrics and Palliative Care 45. Behavioral versus Pharmacological Treatment for Insomnia in the Elderly 285 Michael E. Hochman 4 6. Treatment of Hypertension in the Elderly: The HYVET Trial 291 Kristopher J. Swiger 47. Use of Feeding Tubes in Patients with Dementia 297 Steven D. Hochman 48. Early Palliative Care in Non-Small-Cell Lung Cancer 303 Michael E. Hochman
xi
xii
SECTION 11 Mental Health 49. Initial Treatment of Depression 311 Michael E. Hochman 50. Symptom-Triggered versus Fixed-Dose Therapy for Alcohol Withdrawal 317 Kristopher J. Swiger Index 323
Contents
PREFACE
This book was written as part of the 50 Studies Every Doctor Should Know series, with the goal of familiarizing practicing health care providers, trainees, and interested patients with the key studies that form the evidence foundation of adult medicine. The literature upon which we base clinical decisions often feels overwhelming. For the individual trying to make decisions in clinical practice or on the wards, understanding the medical literature may feel both impractical and at times irrelevant. After all, guidelines from professional societies specify best practices in a digestible format. Is that not sufficient? The trouble is that clinical decision making is often nuanced. For example, recent guidelines recommend a blood pressure target of 35, those with poorly controlled diabetes mellitus or dyslipidemia, those with a cardiovascular
10
P r e v e nti v e M e dicin e
event in the previous 6 months, renal insufficiency, or a chronic disease that could interfere with participation. Also excluded were patients taking medications affecting blood pressure, those with heavy alcohol use, and those unwilling or unable to discontinue supplements or antacids containing magnesium or calcium. How Many Patients: 459 Study Overview: See Figure 2.1 for a summary of the study’s design. Patients with Prehypertension or Stage I Hypertension Randomized
Control Diet
Fruits and Vegetables Diet
Combination (DASH) Diet
Figure 2.1 Summary of the Study Design.
Study Intervention: Participants were randomized to one of three diets: • Control diet: Potassium, magnesium, and calcium levels at the 25th percentile of US consumption, and protein, carbohydrates, fats, and fiber at average US consumption (“typical American diet”). • Fruits and vegetables diet: Potassium and magnesium levels at the 75th percentile of US consumption and high content of fiber, fruits, and vegetables. • Combination (DASH) diet: High content of fiber, fruits, and vegetables (fruits and vegetables diet) plus high in protein and low-fat dairy; also low in saturated and total fat. All diets were low in sodium (3,000 mg/day). Participants followed their prescribed diets for 8 weeks. Each day, participants ate one meal at the study center and were provided meals to be eaten offsite. Participants were instructed to avoid nonstudy food and to limit caffeinated beverages to fewer than three per day and alcoholic beverages to fewer than two per day. The total calories per day were adjusted for the participants to maintain a stable weight. Follow-Up: 8 weeks.
Dietary Approaches to Stop Hypertension
11
Endpoints: Primary outcome: Change in diastolic blood pressure. Secondary outcome: Change in systolic blood pressure. RESULTS
• Baseline characteristics were similar between the groups with a mean age of 44 years and mean blood pressure of 132/85; 51% of participants were female and 59% were black. • Adherence to the prescribed diets was high for all three groups. • The mean decrease in blood pressure was greater in the combination (DASH) diet compared to the fruits and vegetables diet and the control diet (Table 2.1). • The mean decrease in blood pressure was most pronounced among patients enrolled with a diagnosis of hypertension (Table 2.1) and was consistent across several subgroups, including those stratified by gender and minority status. • The mean decrease in systolic blood pressure was greater in the fruits and vegetables diet compared to the control diet (−2.8 mm Hg, P < 0.001). Table 2.1. Summary of Key Findings DASH P Value Diet versus Control Diet −5.5 mm Hg