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JAMA - recientes

Highlights for August 15, 2017
15/8/2017
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A Proposal for Dental, Vision, and Hearing Service Coverage Under Medicare
15/8/2017
Willink A, Schoen C, Davis K.
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This Viewpoint argues that Medicare coverage should be expanded to include dental, vision, and hearing services, and discusses ways to structure the benefit.

Diagnostic Stewardship to Improve Antimicrobial Use
15/8/2017
Morgan DJ, Malani P, Diekema DJ.
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This Viewpoint discusses the potential benefits and harms of diagnostic stewardship—modifying the ordering, performance, and reporting of diagnostic tests to improve treatment—as a means of reducing inappropriate antibiotic use.

Value-Based Pricing and State Reform of Prescription Drug Costs
15/8/2017
Hwang TJ, Kesselheim AS, Sarpatwari A.
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This Viewpoint discusses a New York law that allows the state to negotiate rebates with manufacturers to obtain value-based prices for drugs in its Medicaid program and assesses the potential effects of value-based pricing.

Climate Change—WWLD
15/8/2017
Kaelin WG, Jr.
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Twenty-five years as a physician-scientist have taught me a few things about science and scientists that help me when viewing the climate change debate. For example, some scientists really are, as frequently portrayed in the media, a bit eccentric. They are often curiosity-driven loners with an insatiable need to explore, to know. Scientists are skeptical of the scientific findings of others, and the best of them are equally distrustful of their own work. Most are truth seekers who know that their legacies will be determined by whether their discoveries withstand the test of time.

Trials and Tribulations
15/8/2017
Brown JL.
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Reviewing malpractice cases as a medical expert was an unexpected consequence of testifying as a defendant. I and other physicians in our group practice had been named in a medical malpractice lawsuit. My testimony was required when the case went to trial. After the legal issues were resolved, our attorney suggested that my credentials and demeanor would make me a credible expert witness. Despite having initial reservations, I accepted her offer to review cases because participating in the process seemed preferable to passively accepting any future legal intrusions.

Balancing Needs for Access and Empirical Evidence of Benefit and Risk
15/8/2017
Califf RM.
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When people use medical products, they generally expect that the benefits of doing so will outweigh the risks in terms of living longer, feeling better, or improving their functional status. However, most drugs and biologics and many medical devices that enter early evaluation in humans are found either to have no benefit or to have risks that outweigh the observed benefits when proper clinical trials are conducted. The complexity and high failure rates of medical product development have appropriately led to a regulatory system that requires compelling evidence of safety and efficacy from clinical trials for drugs, biologics, and high-risk devices before they are allowed on the market.

Shared Decision Making and Improving Health Care
15/8/2017
Montori VM, Kunneman M, Brito JP.
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Achieving health care of higher quality at lower cost has fueled policy interest in shared decision making (SDM). In SDM, clinicians and patients work together to understand the patient’s situation and determine how best to address it. Programs are in place in the United States to promote SDM using legal and financial incentives, mostly by implementing patient decision aids (PtDAs). The Cochrane review of SDM tools for people facing treatment or screening decisions is the key evidence cited in policy statements that propose to implement, distribute, and use certified PtDAs.

Characteristics of Studies Used for FDA Approval of High-Risk Device Supplements
15/8/2017
Zheng SY, Dhruva SS, Redberg RF.
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This study characterizes the quality of clinical studies and data used to support US Food and Drug Administration approval of modifications to high-risk medical devices.

Characteristics of Drug Trials Before and After FDA Accelerated Approval
15/8/2017
Naci H, Smalley KR, Kesselheim AS.
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This study uses public US Food and Drug Administration (FDA) data to characterize drug trials used to obtain FDA accelerated approval and to describe the existence, timing, and characteristics of postapproval trials mandated by the FDA as part of the accelerated approval decision.

Effect of a Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes
15/8/2017
Johansen M, MacDonald C, Hansen K, et al.
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This randomized clinical trial compared the effects of an intensive lifestyle intervention vs standard care on glycemic control and medication reduction among participants with non–insulin-dependent type 2 diabetes.

Celiac Disease and Nonceliac Gluten Sensitivity
15/8/2017
Leonard MM, Sapone A, Catassi C, et al.
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This review discusses the the role of a gluten-free diet in the clinical management of celiac disease and nonceliac gluten sensitivity and highlights the importance for long-term therapy of distinguishing between these conditions.

Patient Decision Aids to Engage Adults in Treatment or Screening Decisions
15/8/2017
Stacey D, Légaré F, Lewis KB.
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This Clinical Evidence Synopsis summarizes a Cochrane review of clinical trials evaluating patient decision aids designed to help patients understand their treatment options.

Bezlotoxumab (Zinplava) for Prevention of Recurrent Clostridium Difficile Infection
15/8/2017
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This Medical Letter review summarizes the indications, risks, and benefits of bezlotoxumab, a monoclonal antibody to be used with antibacterial drug treatment to reduce recurrence of Clostridium difficile infection in adults at high risk.

Public Response to a Field Trial of Genetically Engineered Mosquitoes
15/8/2017
Bloss CS, Stoler J, Brouwer KC, et al.
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This study assesses public response to a proposed field trial in the United States of genetically engineered mosquito (OX513A) designed to suppress wild-type Aedes aegypti mosquitoes, which can transmit diseases such as Zika, dengue, and chikungunya.

Prenatal Antidepressant Use and Autism Spectrum Disorder
15/8/2017
Singal D, Chateau D, Brownell M.
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To the Editor The study by Dr Brown and colleagues concluded that in utero serotonergic antidepressant exposure was not associated with the development of autism spectrum disorder in children. However, we conclude that the opposite may be true.

Prenatal Antidepressant Use and Autism Spectrum Disorder—Reply
15/8/2017
Vigod SN, Gomes T, Ray JG.
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In Reply Ms Singal and colleagues raise some points about analysis and interpretation of epidemiological research and our study. The relationship between antenatal serotonergic reuptake inhibitor antidepressant use and child autism spectrum disorder is a complex area about which there is ongoing need for high-quality research.

Maternal Antidepressant Use and Pregnancy Outcomes
15/8/2017
Yonkers K, Forray A, Smith MV.
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To the Editor Maternal antidepressant use has become a commonly explored pregnancy exposure, with investigators using large registry databases to investigate associations with a variety of pregnancy outcomes. Ms Sujan and colleagues investigated outcomes previously associated with maternal antidepressant use, including preterm birth, small for gestational age, autism spectrum disorder, and attention-deficit/hyperactivity disorder, using Swedish registries. A sibling design controlled for confounding and reduced estimates associating maternal antidepressant use with all exposures. The authors performed additional analyses designating as exposures antidepressant use prior to pregnancy and paternal use of antidepressants; these models resulted in similar estimates of association with those that used antidepressants in the first trimester as the exposure. The sibling design supports inferences showing a role for familial and stable socioeconomic and environmental factors. The additional analyses support a role for maternal psychiatric illness.

Maternal Antidepressant Use and Pregnancy Outcomes
15/8/2017
D’Onofrio BM, Sujan AC.
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In Reply We examined the associations between maternal antidepressant use during the first trimester and offspring birth and neurodevelopmental problems. We explored whether the observed associations were consistent with a causal influence or due to alternative processes, such as confounding by indication, genetic factors, environmental factors, or some combination.

Alveolar Recruitment Strategies After Cardiac Surgery
15/8/2017
Li G, Shi X.
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To the Editor Dr Costa Leme and colleagues reported that an intensive alveolar recruitment strategy resulted in less-severe pulmonary complications than a moderate alveolar recruitment strategy among patients with hypoxemia after cardiac surgery. However, we have several concerns about the study.







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