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Julia H. Hayes, MD; Daniel A. Ollendorf, MPH; Steven D. Pearson, MD, MSc; Michael J. Barry, MD; Philip W. Kantoff, MD; Pablo A. Lee, BS; and Pamela M. McMahon, PhD

The optimal management of men with low-risk, localized prostate cancer is a topic of debate. This cost-effectiveness analysis based on trial data estimated that observation with watchful waiting or active surveillance was more effective and less costly than initial treatment. In addition, when compared with active surveillance, watchful waiting was more effective and less costly than active surveillance. Sensitivity analyses showed that treatments would need to be markedly more effective than current options for this conclusion to be overturned.

Topics: watchful waiting, prostate cancer, cost-effectiveness analysis, pivot trial, intensity-modulated radiation therapy
  
Kenneth W. Mahaffey, MD; Daniel Wojdyla, MS; Graeme J. Hankey, MD; Harvey D. White, DSc; Christopher C. Nessel, MD; Jonathan P. Piccini, MD; Manesh R. Patel, MD; Scott D. Berkowitz, MD; Richard C. Becker, MD; Jonathan L. Halperin, MD; Daniel E. Singer, MD; Robert M. Califf, MD; Keith A.A. Fox, MBChB; Günter Breithardt, MD; and Werner Hacke, MD, PhD

A recent randomized, controlled trial found rivaroxaban noninferior to vitamin K antagonists (VKAs) for anticoagulation in patients with atrial fibrillation. In a subanalysis of the trial that compared patients already receiving a VKA at randomization with those who were VKA-naive, rivaroxaban resulted in more bleeding events in the first 7 days of therapy but fewer events after 30 days of therapy than VKAs. These findings may be useful to clinicians considering a transition to rivaroxaban for patients receiving VKA therapy.

Topics: atrial fibrillation, warfarin, vitamin k antagonist, rivaroxaban, rocket trial, hemorrhage, international normalized ...
  
Amit M. Patel, MD; Salimah Shariff, PhD; David G. Bailey, BScPhm, PhD; David N. Juurlink, MD, PhD; Sonja Gandhi, BSc; Muhammad Mamdani, PharmD, MPH; Tara Gomes, MHSc; Jamie Fleet, BSc; Y. Joseph Hwang, BMSc; and Amit X. Garg, MD, PhD

Some antibiotics increase blood values of commonly prescribed statins by inhibiting the liver enzyme that metabolizes them. This population-based study used linked health care databases in Ontario, Canada, to measure the frequency of statin toxicity after coprescription of a statin with clarithromycin or erythromycin. It found that older people taking statins who were prescribed clarithromycin or erythromycin had more hospitalizations for rhabdomyolysis and acute kidney injury and higher all-cause mortality than those prescribed azithromycin.

Topics: erythromycin, statins, clarithromycin, macrolides, toxic effect, azithromycin, rhabdomyolysis
  
Mark C. Simmonds, PhD, MA; Jennifer V.E. Brown, MSc, BA; Morag K. Heirs, MSc, MA; Julian P.T. Higgins, PhD, BA; Richard J. Mannion, PhD; Mark A. Rodgers, MSc, BSc; and Lesley A. Stewart, PhD, MSc, BSc

Recombinant human bone morphogenetic protein-2 (rhBMP-2) is used to promote fusion in spinal surgery, but its safety has been questioned. This review is 1 of 2 commissioned by the Yale University Open Data Access (YODA) Project to meta-analyze individual-participant data from randomized trials of rhBMP-2 in spinal fusion surgery to evaluate the effectiveness and safety of rhBMP-2. It concludes that at 2 years, rhBMP-2 increased fusion rates, reduced pain by a clinically insignificant amount, and increased early postsurgical pain compared with iliac crest bone graft. Cancer was more common after rhBMP-2, but too few events occurred to make definitive conclusions.

Topics: spinal fusion, spinal procedure, recombinant human bone morphogenetic protein-2, bone graft harvest ...
  
Rongwei Fu, PhD; Shelley Selph, MD; Marian McDonagh, PharmD; Kimberly Peterson, MS; Arpita Tiwari, MHS; Roger Chou, MD; and Mark Helfand, MD, MS

Recombinant human bone morphogenetic protein-2 is used to promote fusion in spinal surgery, but its safety has been questioned. This review is 1 of 2 commissioned by the YODA Project to meta-analyze individual-participant data from randomized trials of rhBMP-2 in spinal fusion surgery to evaluate the effectiveness and safety of rhBMP-2. It concludes that rhBMP-2 has no clinical advantage in spinal fusion over bone graft and may be associated with important harms, making it difficult to identify clear indications for rhBMP-2. The researchers also identified sources of bias in the initial trial reports.

Topics: spinal fusion, spinal procedure, recombinant human bone morphogenetic protein-2, bone graft harvest ...
  

This Update summarizes studies published in 2012 that the authors consider highly relevant to the practice of rheumatology. Topics include treatment of rheumatologic disease, pharmacoepidemiology, diagnostic testing, and new practice guidelines.

Topics: rheumatoid arthritis, arthritis, rheumatology, vasculitis, cryoglobulinemic, gout, anti-inflammatory agents, non-steroidal, rituximab, guidelines ...
  
Keith E. Kocher, MD, MPH; and Brent R. Asplin, MD, MPH

The fundamental question of where patients with acute care needs should go for unscheduled care is left inadequately answered in the debate over health care reform. This commentary discusses the burden of and an ideal system for acute unscheduled care.

Topics: primary health care, acute care, urgent care
  
Harlan M. Krumholz, MD, SM; Joseph S. Ross, MD, MHS; Cary P. Gross, MD; Ezekiel J. Emanuel, MD, PhD; Beth Hodshon, JD, MPH, RN; Jessica D. Ritchie, MPH; Jeffrey B. Low, AB; and Richard Lehman, MD

Two systematic reviews on rhBMP-2 in this issue are based on patient-level data from all clinical trials conducted by Medtronic, which were shared through the YODA Project—an unprecedented step in data sharing. The editorialists, all affiliated with the project, discuss how the Medtronic proposal unfolded and hope that it contributes to a cultural shift in thinking about data sharing.

Topics: evidence-based medicine, data reporting, recombinant human bone morphogenetic protein-2, clinical research, false-positive ...
  

There has been considerable controversy surrounding the promotion and use of rhBMP-2 for spinal fusion. In this issue, 2 meta-analyses based on patient-level trial data examine the benefits and harms associated with rhBMP-2. The editorialists discuss how these findings should guide clinical decision making and future research to define the role of rhBMP-2 in spinal surgery.

Topics: spinal fusion, spinal procedure, recombinant human bone morphogenetic protein-2, bone graft harvest ...
  

The 2 reviews in this issue on rhBMP-2 analyzed patient-level data from Medtronic-sponsored clinical trials. The editorialist, from Medtronic, discusses the data-sharing experience with the YODA project and why he believes that more open research is critical to achieve balanced inferences that most benefit patients and society.

Topics: industry, data reporting, clinical research
  
Christine Laine, MD, MPH, Editor in Chief; Eliseo Guallar, MD, PhD, Associate Editor, Statistics; Cynthia Mulrow, MD, MSc, Senior Deputy Editor; Darren B. Taichman, MD, PhD, Executive Deputy Editor; John E. Cornell, PhD, Associate Editor, Statistics; Deborah Cotton, MD, MPH, Deputy Editor; Michael E. Griswold, PhD, Associate Editor, Statistics; A. Russell Localio, JD, MPH, MS, Associate Editor, Statistics; Anne R. Meibohm, PhD, Associate Editor, Statistics; Catharine B. Stack, PhD, MS, Deputy Editor, Statistics; Sankey V. Williams, MD, Deputy Editor; and Steven N. Goodman, MD, PhD, MHS, Associate Editor, Statistics

This issue includes 2 systematic reviews that use the same data to address the same question: Compared with iliac crest bone grafting, does rhBMP-2 safely improve outcomes of spinal fusion surgery? The Editors discuss how these reviews spotlight the power of evidence synthesis, data sharing, peer review, and reproducible research.

Topics: peer review, reproducibility of results, data reporting, recombinant human bone morphogenetic protein-2, ...
  
Leslie G. Cohen, MD
Includes: Audio/Video

The rhythmic beat of once-familiar swing music jogged my memory. Was it “One O'Clock Jump” or “Cottontail”? I know I'd heard it before, many times long ago. Suddenly I remembered a patient, Gladys Spink, and smiled. It all came back.

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George C. Roush, MD, MPH; Theodore R. Holford, PhD; and Achuta K. Guddati, MBBS, PhD
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James J. DiNicolantonio, PharmD; James H. O'Keefe, MD; and Carl J. Lavie, MD
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Paula T. Einhorn, MD, MS; William C. Cushman, MD; Paul K. Whelton, MB, MD, MSc, for the ALLHAT Collaborative Research Group
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Irfan A. Dhalla, MD, MSc; Muhammad M. Mamdani, PharmD, MA, MPH; and David N. Juurlink, MD, PhD
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Paul D. Blanc, MD, MSPH
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Karin Leder, MBBS, MPH, PhD; Michael D. Libman, MD; and Mark J. Sotir, PhD, MPH
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Topics: chronic obstructive airway disease, mortality, inhaled corticosteroid, long-acting inhaled beta-agonist
  
Topics: mediterranean diet, fat-restricted diet, cardiovascular event, predimed trial
  
Topics: renal failure, acute, critical illness, hetastarch, mortality
  
Topics: clopidogrel, percutaneous coronary intervention, ischemia, hemorrhage, cangrelor, champion phoenix trial
  
Topics: aspirin, anticoagulants, oral, clopidogrel, percutaneous coronary intervention, woest trial, hemorrhage
  
Topics: peripheral vascular diseases, ramipril, intermittent claudication
  
Topics: colorectal cancer, reminder systems, electronic medical records, colorectal cancer screening
  
Topics: coronary angiography, radiographic contrast agent nephropathy, citrates, potassium citrate, sodium citrate
  
Topics: antioxidants, vitamins, cardiovascular event
  
Topics: delirium, elderly, elderly fall
  
Topics: pregnancy, fetal death, selective serotonin re-uptake inhibitors, neonatal mortality
  
Topics: case management, elderly, hospital admission
  
Topics: atrial fibrillation, vitamin k antagonist, rivaroxaban
  
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