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Highlights

from JAMA - 17 Feb 15



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Stealth Research Is Biomedical Innovation Happening Outside the Peer-Reviewed Literature?

from JAMA - 17 Feb 15

This Viewpoint discusses the need for scientific transparency when biomedical innovation takes place outside of the peer-reviewed literature.



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In Defense of the Employer Mandate Hedging Against Uninsurance

from JAMA - 17 Feb 15

This Viewpoint traces the origins of the Affordable Care Act’s employer mandate provision, delineates its all-important rationale, and discusses the likelihood and consequences of its potential repeal.



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FDA Regulation of Laboratory-Developed Diagnostic Tests Protect the Public, Advance the Science

from JAMA - 17 Feb 15

This Viewpoint discusses the need for regulation meant to ensure the quality, safety, and validity of laboratory-developed diagnostic tests.



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Genetic Testing and FDA Regulation Overregulation Threatens the Emergence of Genomic Medicine

from JAMA - 17 Feb 15

This Viewpoint discusses potential drawbacks of regulation meant to to ensure the quality, safety, and validity of laboratory-developed diagnostic tests.



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The Other AMA

from JAMA - 17 Feb 15

Many in academic medicine approach July with a touch of dread. The seismic turnover to brand-new trainees creates a chaotic few weeks, making even a long New England winter seem almost attractive. For me, however, July serves as a perennial reminder of our humble origins and an opportunity to appreciate the magnitude of one’s personal evolution: how we have grown in our medical knowledge; how we have grown in our capacity to handle the stress of constantly being around illness; how we have foun



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Corticosteroids for Severe Community-Acquired Pneumonia Not for Everyone

from JAMA - 17 Feb 15

Corticosteroids are the physician’s immunomodulatory agent of choice. These agents are inexpensive and ubiquitously available, have a well-known adverse effect profile, do not require monitoring of drug levels, and, probably most important, mimic the body’s own response to stress. Accordingly, corticosteroids have been used for a wide variety of medical illnesses. Use of corticosteroids for acute illness has always been controversial, no more so than for treating the triad of community-acquired



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To JAMA Authors, Peer Reviewers, and Readers—Thank You

from JAMA - 17 Feb 15

Major medical journals interact with and serve numerous constituencies, although none are more important than authors, peer reviewers, and readers and listeners. A journal is only as good as the entirety of its content, as determined by the importance and caliber of the manuscripts that authors submit; its scientific rigor, as determined by the quality control and improvement that thoughtful peer reviewers and the editorial process provide; and its influence, as determined by the application and



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Effect of Corticosteroids on Treatment Failure Among Hospitalized Patients With Severe Community-Acquired Pneumonia and High Inflammatory Response A Randomized Clinical Trial

from JAMA - 17 Feb 15

ImportanceIn patients with severe community-acquired pneumonia, treatment failure is associated with excessive inflammatory response and worse outcomes. Corticosteroids may modulate cytokine release in these patients, but the benefit of this adjunctive therapy remains controversial.ObjectiveTo assess the effect of corticosteroids in patients with severe community-acquired pneumonia and high associated inflammatory response.Design, Setting, and ParticipantsMulticenter, randomized, double-blind, p



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Effect of Varenicline on Smoking Cessation Through Smoking Reduction A Randomized Clinical Trial

from JAMA - 17 Feb 15

ImportanceSome cigarette smokers may not be ready to quit immediately but may be willing to reduce cigarette consumption with the goal of quitting.ObjectiveTo determine the efficacy and safety of varenicline for increasing smoking abstinence rates through smoking reduction.Design, Setting, and ParticipantsRandomized, double-blind, placebo-controlled, multinational clinical trial with a 24-week treatment period and 28-week follow-up conducted between July 2011 and July 2013 at 61 centers in 10 co



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Effect of Oral Eliglustat on Splenomegaly in Patients With Gaucher Disease Type 1 The ENGAGE Randomized Clinical Trial

from JAMA - 17 Feb 15

ImportanceGaucher disease type 1 is characterized by hepatosplenomegaly, anemia, thrombocytopenia, and skeletal disease. A safe, effective oral therapy is needed.ObjectiveTo determine whether eliglustat, a novel oral substrate reduction therapy, safely reverses clinical manifestations in untreated adults with Gaucher disease type 1.Design, Setting, and ParticipantsPhase 3, randomized, double-blind, placebo-controlled trial conducted at 18 sites in 12 countries from November 2009 to July 2012 amo



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Association Between the Use of Fondaparinux vs Low-Molecular-Weight Heparin and Clinical Outcomes in Patients With Non–ST-Segment Elevation Myocardial Infarction

from JAMA - 17 Feb 15

ImportanceFondaparinux was associated with reduced major bleeding events and improved survival compared with low-molecular-weight heparin (LMWH) in a large randomized clinical trial involving patients with non–ST-segment elevation myocardial infarction (NSTEMI). Large-scale experience of the use of fondaparinux vs LMWH in a nontrial setting is lacking.ObjectiveTo study the association between the use of fondaparinux vs LMWH and outcomes in patients with NSTEMI in Sweden.Design, Setting, and Pati



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Starting a New Discussion About Screening for Lung Cancer

from JAMA - 17 Feb 15

JAMA Internal MedicineOverdiagnosis in Low-Dose Computed Tomography Screening for Lung CancerEdward F. Patz Jr, MD; Paul Pinsky, PhD; Constantine Gatsonis, PhD; JoRean D. Sicks, MS; Barnett S. Kramer, MD, MPH; Martin C. Tammemägi, PhD; Caroline Chiles, MD; William C. Black, MD; Denise R. Aberle, MD; for the NLST Overdiagnosis Manuscript Writing TeamImportance Screening for lung cancer has the potential to reduce mortality, but in addition to detecting aggressive tumors, screening will also dete



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Use of Pneumococcal Vaccine in Adults

from JAMA - 17 Feb 15

This JAMA Clinical Guidelines Synopsis article evaluates the most recent Advisory Committee for Immunization Practices guideline on use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged 65 years or older.




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Heart Rate and Body Temperature Responses to Extreme Heat and Humidity With and Without Electric Fans

from JAMA - 17 Feb 15

Patz et al described the projected effects of more prolonged and severe heat waves on human health. A simple, low-cost cooling device is an electric fan. A Cochrane review concluded “no evidence currently exists supporting or refuting the use of electric fans during heat waves” for mortality and morbidity. However, public health guidance typically warns against fan use in hot weather. Recommended upper limits range from 32.3°C (90°F) at 35% relative humidity (RH) to the high 90s (96-99°F; 35.6-3



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Fecal Microbiota Transplantation for Clostridium difficile Infection

from JAMA - 17 Feb 15

To the Editor: Since the first description of successful fecal microbiota transplantation (FMT) via stool enemas for severe Clostridium difficile infection (CDI) in 1958, FMT has consistently achieved treatment success rates of approximately 90%. In previous work, Youngster et al demonstrated that it is possible to freeze stool prior to FMT, thus greatly facilitating the process. In the most recent study, Dr Youngster and colleagues have taken steps to transform FMT from an invasive, nonacute pr



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Fecal Microbiota Transplantation for Clostridium difficile Infection—Reply

from JAMA - 17 Feb 15

In Reply: Dr Armstrong and colleagues are concerned that we have compromised a phase 1 study design by incorporating a sample size calculation and by using historical data as a statistical comparator. Traditional phase 1 investigations, or first-in-human studies, are used to determine the dose and schedule of an investigational therapeutic while assessing for potential toxic effects.



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Adapting to Climate Change

from JAMA - 17 Feb 15

To the Editor Dr Patz and colleagues raised concerns about the adverse health effects of climate change. They reviewed the evidence on the effects to date of the future risks from a changing climate and the opportunities for effective action to reduce risks. Although the authors urged public health preparedness (adaptation) to climate change, there could be limits to the effectiveness of adaptation.



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Adapting to Climate Change—Reply

from JAMA - 17 Feb 15

In Reply We agree with Dr Huang and colleagues that there are limits to human beings’ capacity to adapt to climate change, especially if preventive measures are not at the level of full society, multisector interventions. Climate change is neither a conventional single disease agent or toxic exposure nor an individual behavior that can be changed through medical technology or classic public health interventions. It represents a risk that can undermine societal stability and disrupt life-supporti



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Goals of Displaying Health Care Prices to Physicians

from JAMA - 17 Feb 15

To the Editor The price of medical care is an essential component in the assessment of value. Drs Riggs and DeCamp discussed concerns about the display of price to physicians. The discussion is confounded when expanded to the goal of informing patients and ensuring fairness.



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Goals of Displaying Health Care Prices to Physicians—Reply

from JAMA - 17 Feb 15

In Reply We agree with Dr Hoffer that prices are an essential component in assessing value and in general have no objection to the use of price displays. Rather, we argued in our Viewpoint that since different displayed “prices” (eg, hospital list price vs Medicare fee amount) might differentially affect physician behavior, it is important to consider how different prices might operate in practice and weigh the ethical implications of each.



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Clarification of 2 Sentences

from JAMA - 17 Feb 15

In the Editorial entitled “Patient-Centered Medical Home for High-Risk Children With Chronic Illness” published in the December 24/31, 2014, issue of JAMA (2014;312[24]:2625-2626. doi:10.1001/jama.2014.16514), clarification is needed for the first 2 sentences of the last paragraph on page 2625. Those 2 sentences should be replaced with “The medical school subsidized the experimental program in this study, which was important to both start and maintain the program, and incurred a deficit estimate



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Corrected Data and Wording in Related Editorial

from JAMA - 17 Feb 15

In the Editorial entitled “Race, Ethnicity, and the Diagnosis of Breast Cancer” published in the January 13, 2015, issue of JAMA (2015;313[2]:141-142. doi:10.1001/jama.2014.17323), data and wording were discordant with the related article. In the middle of the second paragraph, the 7-year mortality rates were updated to reflect the actuarial data in the article by Iqbal et al. The last sentence of the second paragraph was updated to reflect that the mortality difference was statistically signifi



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Incorrect Text

from JAMA - 17 Feb 15

In the Special Communication entitled “Management of Sickle Cell Disease: Summary of the 2014 Evidence-Based Report by Expert Panel Members” published in the September 10, 2014, issue of JAMA (2014;312[10]:1033-1048. doi:10.1001/jama.2014.10517), the last sentence before the Discussion section should read, “The panel makes explicit recommendations in Table 9 against the routine use of transfusions in uncomplicated vasoocclusive crises, priapism, asymptomatic anemia, acute kidney injury in the ab


 

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