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Highlights for December 26, 2017

Mar, 26/12/2017 - 01:00

Encouraging New Uses for Old Drugs

Mar, 26/12/2017 - 01:00
This Viewpoint discusses ways in which government agencies could encourage discovery of new indications for older, off-patent drugs.

Continued US Investment to Sustain Momentum Toward Global Health Security

Mar, 26/12/2017 - 01:00
This Viewpoint discusses the importance of the United States’ commitment to support the Global Health Security Agenda to help protect the nation and the world from epidemic disease.

The Potential Adverse Influence of Physicians’ Words

Mar, 26/12/2017 - 01:00
This Viewpoint discusses how physicians’ choice of words can amplify patients’ symptoms and distress and suggests approaches to communication in common situations that could reduce iatrogenic nocebo effects.

Transforming TRICARE and the Military Health System

Mar, 26/12/2017 - 01:00
This Viewpoint describes the five lines of reform the US Department of Defense is implementing for its TRICARE health plan, the main provider of health care services to enlisted service members in all military branches, their families, and retirees.

Negative Capability and the Art of Medicine

Mar, 26/12/2017 - 01:00
This essay ponders John Keats’ erstwhile mention of negative capability as a prelude to identifying the art of treating patients that reaches beyond or within the bounds of science.

Low-Level Air Pollution Associated With Death

Mar, 26/12/2017 - 01:00
Globally, an estimated 3.3 million annual premature deaths (5.86% of global mortality) are attributable to outdoor air pollution, although ambient air pollution has been regulated under national laws in many countries. In the United States under the Clean Air Act, the primary National Ambient Air Quality Standards (NAAQS) are intended to protect human health, with an adequate margin of safety, including sensitive populations such as children, older adults, and individuals with respiratory diseases. Under the Clean Air Act, the standards are reviewed every 5 years to account for new scientific evidence regarding their appropriateness and adequacy for protecting public health.

Authorship and Team Science

Mar, 26/12/2017 - 01:00
The complexity, scope, and scale of scientific research have expanded substantially. During the past several decades, there has been increasing prevalence of large, international, multicenter clinical trials; multidisciplinary investigations involving interventional studies or observational research; and studies that combine large data sets (“big data”) from multiple cohorts or research consortia and use sophisticated analytic methods, such as in some studies involving genomic research or machine learning. This trend toward increasingly collaborative research involving multiple investigators and research groups has been referred to as group science, ensemble science, or more commonly, team science. How authors and nonauthor collaborators can be identified in publications to ensure appropriate credit and recognition of team science is evolving, can be challenging, and is of great importance to the scientific community and individual investigators.

Effect of Antibiotic Prophylaxis on SSIs After Orthopedic Implant Removal

Mar, 26/12/2017 - 01:00
This randomized clinical trial compares the effects of a single preoperative dose of cefazolin vs saline on the incidence of surgical site infection following removal of orthopedic implants used for treatment of below-knee fractures.

Association of Short-term Exposure to Air Pollution With Mortality in Older Adults

Mar, 26/12/2017 - 01:00
This case-crossover study estimates the association between short-term exposures to ambient fine particulate matter and ozone and mortality in the continental United States.

Risk Factors in Young Adulthood and Racial Disparity in Incident Type 2 Diabetes

Mar, 26/12/2017 - 01:00
This study uses data from the observational Coronary Artery Risk Development in Young Adults study to assess disparity in diabetes risk between black and white middle-aged adults.

Effects of Calcium or Vitamin D on Fractures in Older Adults

Mar, 26/12/2017 - 01:00
This meta-analysis summarizes the effects of calcium, vitamin D, or combined calcium and vitamin D supplements on fracture incidence among community-dwelling older adults.

Sports-Related Eye Injuries

Mar, 26/12/2017 - 01:00
This commentary discusses a cross-sectional analysis published in JAMA Ophthalmology describing incidence of sports-related ocular trauma in US emergency departments.

Insulin Dosing Error in a Patient With Severe Hyperkalemia

Mar, 26/12/2017 - 01:00
This JAMA Performance Improvement article uses the case of a patient who received an overdose of insulin to discuss proper protocol and follow-up after a medication dosing error.

Guselkumab (Tremfya) for Psoriasis

Mar, 26/12/2017 - 01:00
This Medical Letter review summarizes the mechanism of action and adverse effects of guselkumab, an interleukin-23 blocker, for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic or phototherapy.

Trends in Marijuana Use Among Pregnant Females in California, 2009-2016

Mar, 26/12/2017 - 01:00
This study uses data from a large California health care system to investigate trends in prenatal marijuana use from 2009 through 2016.

Azithromycin and Survival After Hematopoietic Stem Cell Transplant

Mar, 26/12/2017 - 01:00
To the Editor Dr Bergeron and colleagues prospectively assessed the effect of azithromycin on airflow decline–free survival after allogeneic hematopoietic stem cell transplantation. In the azithromycin group, azithromycin was administered at a dose of 250 mg orally 3 times a week for 2 years. Unexpectedly, the azithromycin group had increased mortality mainly due to an increased incidence of relapse.

Azithromycin and Survival After Hematopoietic Stem Cell Transplant

Mar, 26/12/2017 - 01:00
In Reply Although interactions between certain macrolides, especially erythromycin, and CNIs are well known, only 2 case reports have suggested that there may be such an interaction with azithromycin. We agree that this could lead to an increase in CNI concentration and thus suppress the graft-vs-leukemia–lymphoma effects, potentially explaining the results of our study. Unfortunately, data on CNI concentrations were not collected for the trial, preventing analysis for all patients. To reply to Dr Fuji, we have collected repeated measurements of blood CNI concentrations that were available for 61 (92%) of all the 66 patients recruited in our center. We then analyzed the potential effect of these time-dependent concentrations on the cause-specific hazard of relapse overall and whether this may have interacted with the effect of azithromycin. There was no evidence of any effect of this concentration on the subsequent cause-specific hazard of relapse (hazard ratio [HR], 0.99; 95% CI, 0.995-1.004; P?=?.79), and this was similarly observed in the experimental group (HR, 1.00; 95% CI, 0.997-1.004; P?=?.76) and the placebo group (HR, 0.989; 95% CI, 0.973-1.004; P?=?.16). In other words, there was no statistical evidence of any interaction of the CNI concentration with the effect of azithromycin (P?=?.08).

Evidence Required for Drugs Granted Accelerated Approval

Mar, 26/12/2017 - 01:00
To the Editor Dr Naci and colleagues showed that the US Food and Drug Administration (FDA) granted accelerated approval to 22 drugs for 24 indications between 2009 and 2013, and postapproval requirements were completed and demonstrated efficacy in only 10 of 24 indications (42%) on the basis of trials that evaluated surrogate measures a minimum of 3 years after approval. Although they concluded that both preapproval and postapproval trials had limitations in the study designs and end points, several issues should be taken into account to fully understand the implication of the study results.

Evidence Required for Drugs Granted Accelerated Approval—Reply

Mar, 26/12/2017 - 01:00
In Reply The heightened complexity required to complete required postapproval confirmatory studies of therapeutic agents granted accelerated approval by the FDA means that the pathway should be reserved for exceptional clinical circumstances. But to qualify for accelerated approval, drugs need only treat serious conditions and generally provide meaningful advantages over available therapies. The FDA interprets these guidelines to exclude other accelerated approval drugs as available therapies and to allow surrogate measures to define drugs’ advantages. This can lead to drugs receiving accelerated approvals in therapeutic areas with existing treatment alternatives. For example, in recent years, carfilzomib, pomalidomide, and panobinostat all received accelerated approvals for the treatment of multiple myeloma despite the availability of other treatment options.

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