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Vincent S. Fan, MD, MPH; J. Michael Gaziano, MD, MPH; Robert Lew, PhD; Jean Bourbeau, MD, MSc; Sandra G. Adams, MD, MS; Sarah Leatherman, MS; Soe Soe Thwin, PhD, MS; Grant D. Huang, PhD, MPH; Richard Robbins, MD; Peruvemba S. Sriram, MD; Amir Sharafkhaneh, MD; M. Jeffery Mador, MD; George Sarosi, MD; Ralph J. Panos, MD; Padmashri Rastogi, MD; Todd H. Wagner, PhD; Steven A. Mazzuca, PhD; Colleen Shannon, MPH; Cindy Colling, RPH, MS; Matthew H. Liang, MD, MPH; James K. Stoller, MD, MS; Louis Fiore, MD, MPH; and Dennis E. Niewoehner, MD

This trial comparing usual care with a care management program (patient education, action plans for exacerbations, and scheduled telephone calls with case managers) was stopped early when the data safety monitoring board noted more deaths in the intervention group. The study illustrates the importance of data safety monitoring in behavioral intervention studies.

Topics: chronic obstructive airway disease, hospitalization
Brett Ley, MD; Christopher J. Ryerson, MD, MAS; Eric Vittinghoff, PhD; Jay H. Ryu, MD; Sara Tomassetti, MD; Joyce S. Lee, MD, MAS; Venerino Poletti, MD; Matteo Buccioli, BS; Brett M. Elicker, MD; Kirk D. Jones, MD; Talmadge E. King, MD; and Harold R. Collard, MD

The clinical course of patients with idiopathic pulmonary fibrosis varies, making predicting survival difficult. This study developed and validated 2 models to predict mortality by using variables readily available in clinical encounters (sex, age, FVC, and diffusion capacity). One model used continuous predictors and the other a simple point-scoring system. Each performed well in predicting survival. The models may be useful in identifying patients at heightened risk for death and in guiding care and clinical research.

Topics: pulmonary fibrosis, idiopathic pulmonary fibrosis, mortality
Michael E. Zalis, MD; Michael A. Blake, MB BCh; Wenli Cai, PhD; Peter F. Hahn, MD, PhD; Elkan F. Halpern, PhD; Imrana G. Kazam, PhD; Myles Keroack, MD; Cordula Magee, PhD; Janne J. Näppi, PhD; Rocio Perez-Johnston, MD; John R. Saltzman, MD; Abhinav Vij, MD; Judy Yee, MD; and Hiroyuki Yoshida, PhD

Computed tomographic colonography (CTC) and optical colonoscopy require a laxative bowel preparation, which remains a barrier to colorectal cancer screening. A third screening method, laxative-free CTC, combines the use of low-fiber diet, oral contrast, and postprocessing software to electronically cleanse images. This study compared laxative-free CTC with optical colonoscopy in the same patients and found that laxative-free CTC performed well at detecting adenomas larger than 10 mm but not for smaller lesions.

Topics: adenomatous polyps, computed tomographic colonography, polyps, laxative, adenoma, colonoscopy

People may be at greater risk for colorectal cancer if they have a first-degree relative who has an adenomatous polyp, but that risk is not well-understood. This systematic review found 2 studies that report an increased risk; however, study design problems affect the validity and generalizability of their results. It also found 10 studies that have been cited incorrectly as reporting an increased risk. Further research is needed to inform recommendations about screening for colorectal cancer in patients with a family history of adenomatous polyps.

Topics: colorectal cancer, adenoma, adenomatous polyps, family history
Ignacio Neumann, MD; Gabriel Rada, MD; Juan Carlos Claro, MD; Alonso Carrasco-Labra, DDS; Kristian Thorlund, PhD; Elie A. Akl, MD, MPH, PhD; Shannon M. Bates, MD, MSc; and Gordon H. Guyatt, MD, MSc
Includes: CME

Several strategies to prevent venous thromboembolism are available for patients undergoing major orthopedic surgery. This systematic review examined 22 trials that compared oral factor Xa inhibitors with low-molecular-weight heparin (LMWH) in adults undergoing hip or knee replacement. Reviewers found no important differences in mortality or pulmonary embolism between the 2 drugs. However, compared with LMWH, factor Xa inhibitors decreased the risk for symptomatic deep venous thrombosis (DVT). High, but not lower, doses of factor Xa inhibitors increased bleeding; lower doses reduced risk for symptomatic DVT without increasing bleeding.

Topics: low-molecular-weight heparin, hip replacement arthroplasty, knee replacement arthroplasty, venous thromboembolism, factor xa ...
Diana M. Sobieraj, PharmD; Soyon Lee, PharmD; Craig I. Coleman, PharmD; Vanita Tongbram, MBBS, MPH; Wendy Chen, PharmD; Jennifer Colby, PharmD; Jeffrey Kluger, MD; Sagar Makanji, PharmD; Ajibade O. Ashaye, MD, MPH; and C. Michael White, PharmD
Includes: CME

The optimal duration of thromboprophylaxis after major orthopedic surgery is unclear. This systematic review identified 8 randomized trials that compared prolonged (≥21 days) with standard-duration (7 to 10 days) thromboprophylaxis after major orthopedic surgery in adults. Prolonged prophylaxis decreased the risk for venous thromboembolism, pulmonary embolism, and DVT but increased the risk for minor bleeding. Most data were for hip replacement surgery; applicability of these findings to knee replacement and hip fracture surgery is unclear.

Topics: deep vein thrombosis, thromboprophylaxis, venous thromboembolism, hemorrhage, knee replacement arthroplasty, hip replacement ...
Laura A. Petersen, MD, MPH; Kate Simpson, MPH; Richard SoRelle, BS; Tracy Urech, MPH; and Supicha Sookanan Chitwood, MPH

Randomized, controlled trials are relatively rare in health services research, and institutional review boards (IRBs) may lack experience in reviewing them. The authors compared the outcomes of review of the same proposal for a multisite, minimal-risk trial. They assessed the variability in IRB reviews and the effect of review determinations on site participation, budget, and timeline and found that complying with IRB requirements required substantial resources and threatened the study's internal and external validity.

Topics: institutional review board, health services research
C. Gregory Elliott, MD; and Polly E. Parsons, MD

This Update summarizes studies published in 2011 that the authors consider highly relevant to the practice of pulmonary and critical care medicine.

Topics: chronic obstructive airway disease, care of intensive care unit patient, lung, intensive ...
Anna S.F. Lok, MD; John W. Ward, MD; Robert P. Perrillo, MD; Brian J. McMahon, MD; and T. Jake Liang, MD

Prophylactic antiviral therapy can prevent hepatitis B virus (HBV) reactivation; however, HBV testing before immunosuppressive therapy is recommended but often not done because of lack of awareness, uncertainty regarding who should be screened, and cost. This commentary advocates collaboration between multidisciplinary medical specialists and public health experts to promote recommendations for prevention.

Topics: hepatitis b, therapeutic immunosuppression, hepatitis b virus measurement

Two articles in this issue raise ethical concerns about the conduct and monitoring of clinical trials. Fan and colleagues report a trial of a behavioral intervention strategy for patients with chronic obstructive pulmonary disease that was stopped early because of excess deaths in the intervention group. Petersen and colleagues illustrate how IRB requirements can be time-consuming and can adversely affect a trial's internal and external validity. The editorialist discusses these studies and the importance of ethical safeguards in clinical trials.

Topics: clinical trials, ethics

In this issue, 2 reviews assess the effect of type and duration of thromboprophylaxis in patients undergoing major orthopedic surgery. Neumann and colleagues compared the efficacy and safety of thromboprophylaxis using oral direct factor Xa inhibitors or LMWH. Sobieraj and colleagues compared outcomes of prolonged versus standard-duration thromboprophylaxis after major orthopedic surgery. The editorialists discuss the findings and identify the remaining questions that future studies should address.

Topics: venous thrombosis, orthopedic procedures, hip replacement arthroplasty, knee replacement arthroplasty, thromboprophylaxis, deep ...
Shilpa Bhardwaj, MD, MPH
Includes: Audio/Video
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Keith Brown, MD; Robin Harbour, PhD; and John Petrie, MD, PhD
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Andrea Giaccari, MD, PhD; Carlo B. Giorda, MD; Gabriele Riccardi, MD; Alberto De Micheli, MD; Graziella Bruno, MD; Luca Monge, MD; and Simona Frontoni, MD, PhD
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Wendy L. Bennett, MD, MPH; Olaide A. Odelola, MD, MPH; and Lisa M. Wilson, ScM
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Junichi Hirahashi, MD, PhD; Airi Jo, MD; Kohei Ueda, MD; Akihiro Tojo, MD, PhD; and Toshiro Fujita, MD, PhD
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Luming Li, BA
Includes: Audio/Video
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Peter Glusker, MD
Includes: Audio/Video
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Kalyan Banda, MBBS
Includes: Audio/Video
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Topics: enoxaparin, percutaneous coronary intervention, mortality, coronary heart disease, unfractionated heparin
Topics: acute coronary syndromes, mortality, rivaroxaban
Topics: enoxaparin, warfarin, pulmonary embolism, venous thromboembolism, idrabiotaparinux
Topics: hepatitis, alcoholic, acetylcysteine, prednisolone, mortality
Topics: albuterol, respiratory distress syndrome, adult, mortality
Topics: malignant melanoma, cutaneous, surgical margins
Topics: vitamin d, elderly, muscle strength, test for balance
Topics: biological response modifiers, adverse event
Topics: clobetasol, mometasone furoate, genital lichen sclerosus
Topics: persistent fetal circulation syndrome, pulmonary hypertension, selective serotonin re-uptake inhibitors, late stage ...
Topics: diabetes mellitus, systolic blood pressure, diabetes mellitus, type 2, cholesterol, hemoglobin a, ...
Topics: respiratory distress, postoperative
Topics: chronic obstructive airway disease, comprehensive health care, hospitalization
Topics: computed tomography, colorectal cancer, laxative, colon cancer
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