tag:blogger.com,1999:blog-79576891598642538382023-11-15T10:27:58.911-08:00Latest Fda Approved Drugs Information SystemsUnknownnoreply@blogger.comBlogger2274125tag:blogger.com,1999:blog-7957689159864253838.post-71770116326885415312017-10-20T05:05:00.001-07:002017-10-20T05:05:11.842-07:00Antidepressants Linked to Higher Diabetes Risk in Kids<div dir="ltr" style="text-align: left;" trbidi="on">
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Pediatric patients who use antidepressants may have an elevated risk for type 2 diabetes, the authors of a new study report.</div>
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In a retrospective cohort study of more than 119,000 youths 5 to 20 years of age, the risk for incident type 2 diabetes was nearly twice as high among current users of certain types of antidepressants as among former users, Mehmet Burcu, PhD, and colleagues report in an article <a href="https://jamanetwork.com/journals/jamapediatrics/fullarticle/2656620" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">published online</a>October 16 in <i style="box-sizing: border-box;">JAMA Pediatrics</i>. The risk intensified with increasing duration of use, greater cumulative doses, and higher daily doses of these antidepressants.</div>
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The findings point to a growing need for closer monitoring of these products, including greater balancing of risks and benefits, in the pediatric population, the authors caution.</div>
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They undertook the study because, despite growing evidence of an association between antidepressant use and an increased risk for type 2 diabetes in adults, similar research in pediatric patients was scarce. "To our knowledge, this is the first population-based study of youths that comprehensively examines the risk of incident type 2 diabetes following treatment initiation with an antidepressant," they write.</div>
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For this study, Dr. Burcu, from the Department of Pharmaceutical Health Services Research at the University of Maryland, Baltimore, and colleagues examined Medicaid claim files from California, Florida, Illinois, and New Jersey from January 1, 2004, through December 31, 2009. They restricted the cohort to patients 5 to 20 years of age who began treatment with antidepressants between January 1, 2005, and December 31, 2009. The day on which antidepressant use was initiated was considered the index date.</div>
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The medication classes included selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic or other cyclic antidepressants (TCAs), and other antidepressants. Patients who had taken any of these agents within the 365 days before the index date were excluded from the study. Other exclusion criteria included a diabetes-related health issue in the 365 days before the index date and maternal gestational diabetes.</div>
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To examine the relationship between antidepressants and diabetes, the authors compared incident cases of diabetes among current users of antidepressants — patients who had not discontinued the medications for more than 90 days during the study period — with those in former users. The analysis was adjusted for numerous possible confounders.</div>
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The cohort consisted of 119,608 youths; 50.6% were boys, 47.3% were white, and most (69.5%) were aged 10 to 17 years</div>
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Depressive disorders were the most common diagnosis (37.4%), followed by attention-deficit/hyperactivity disorder (25.9%) and anxiety disorders (17.7%). Disruptive behavior disorder, adjustment disorder, and bipolar disorder were other common diagnoses. Within the year before the index date, 35.4% of patients had used psychiatric medications other than antidepressants, including attention-deficit/hyperactivity disorder drugs and atypical antipsychotics.</div>
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SSRIs and SNRIs were the most common antidepressant classes, used by a total of 79,285 patients (66.3%), for a mean of 179.7 days (median, 90.0 days; interquartile range, 30.0-213.0 days). TCA use was reported by 22,143 patients (18.5%), followed by other antidepressants.</div>
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With a mean follow-up of 22.8 months, 156 current antidepressant users were diagnosed with type 2 diabetes compared with 77 cases among former users. The absolute risks for the two groups were 1.16 per 10,000 person-months and 0.56 per 10,000 person-months, respectively.</div>
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"Overall," the authors write, "when compared with former use, current use of antidepressants was associated with a 1.92-fold increased risk of type 2 diabetes (95% confidence interval [CI], 1.43-fold to 2.57-fold increased risk)," after adjusting for disease risk and time from study entry.</div>
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When analyzed by drug class, all three of the most common antidepressant classes were associated with elevated diabetes risk. Among current users of SSRIs or SNRIs, the absolute risk for diabetes was 1.29 per 10,000 person-months compared with 0.64 per 10,000 person-months among former users (relative risk [RR], 1.88; 95% CI, 1.34 - 2.64). Current use of TCAs was associated with absolute risks of 0.89 vs 0.48 per 10,000 person-months among current and for former users, respectively (RR, 2.15; 95% CI, 1.06 - 4.36).</div>
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The other types of antidepressants were not associated with greater diabetes risk (absolute risk, 1.15 per 10,000 person-months among current users vs 1.12 per 10,000 person-months for former users; RR, 0.99; 95% CI, 0.66-1.50).</div>
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For users of SSRIs or SNRIs, diabetes risk also intensified with duration of use: more than 210 days was associated with an RR of 2.66 (95% CI, 1.45 - 4.88), and use for 151 to 210 days with an RR of 2.56 (95% CI, 1.29 - 5.08) compared with 1 to 90 days of use.</div>
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Similarly, the risk for diabetes increased with higher cumulative doses of SSRIs or SNRIs and with use for more than 150 days at doses greater than 15.0 mg/day.</div>
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TCAs and other antidepressants did not exhibit these effects, although that finding may have been influenced by the more limited exposure to these agents, the authors explain.</div>
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The reasons why serotonin reuptake inhibitors in particular are associated with an elevated risk for type 2 diabetes in both children and adults remain unclear, they write. Although weight gain may play a role, other possible mechanisms include "disturbances in glucose homeostasis, decreased pancreatic insulin secretion, and increased cellular insulin resistance."</div>
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The authors also warn that these findings should be interpreted cautiously because "causality cannot be inferred from observational studies," although they used a rigorous design and approaches to account for statistical confounding.</div>
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Also, depression itself has been associated with weight gain, and with it, a greater risk for type 2 diabetes. However, the authors point out that most of the patients in this study (62.6%) were taking the antidepressants for something other than a depressive disorder.</div>
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These findings "support the need for further research to shed light on the underlying biological mechanisms of treatment-emergent type 2 diabetes associated with antidepressants," the authors conclude. The results also "provide an impetus for policy development to improve monitoring for the benefits vs risks of antidepressant use in pediatric care models, specifically for serotonin reuptake inhibitors, the most commonly used antidepressant class."</div>
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<i style="box-sizing: border-box;">The authors have disclosed no relevant financial relationships.</i></div>
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<i style="box-sizing: border-box;">JAMA Pediatr</i>. Published online October 16, 2017. <a href="https://jamanetwork.com/journals/jamapediatrics/fullarticle/2656620" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">Abstract</a></div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-49748542520421363932017-10-20T05:03:00.005-07:002017-10-20T05:03:56.080-07:00EHR Work Measures Proposed to Address Burnout<div dir="ltr" style="text-align: left;" trbidi="on">
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Electronic health record (EHR) vendors should imbed metrics into their systems to measure how EHRs affect clinicians' work, experts write in a commentary <a href="http://annals.org/aim/article/2657167/novel-metrics-improving-professional-fulfillment" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">published online</a> October 10 in the <i style="box-sizing: border-box;">Annals of Internal Medicine</i>.</div>
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Yumi T. DiAngi, MD, a fellow in clinical informatics at Stanford University School of Medicine in Palo Alto, California, and colleagues propose six areas metrics should cover and recommended the creation of a "national council of clinicians" to design measures and create guidelines to address privacy and other issues.</div>
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"The EHR, which was intended to improve patient care, has had the ironic and unintended consequence of impairing practice efficiency, largely because of poor design, a focus on regulatory reporting, and the burden placed on clinicians by data entry," they write. EHRs have also led to high levels of burnout as physicians' satisfaction in their work has declined, they note.</div>
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To gain insight into the stresses that have produced this burnout, the coauthors suggested the establishment of EHR work metrics in these categories:</div>
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Work after work: The number of hours a clinician spends logged onto the EHR during evenings, weekends, and vacations. The coauthors view this as a key indicator of lifestyle balance.</div>
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Click counts: The number of clicks per day or the number of clicks needed to accomplish common workflow tasks. This measure could help improve work flow at both the local level, with changes to things such as log-in routines, and could drive vendors to make improvements in the EHRs themselves.</div>
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Teamwork: Measures the ratio of staff-entered to physician-entered EHR tasks, such as prescriptions, visit notes, inbox messages, and orders. These metrics could show how well tasks are distributed to the appropriate team members, the authors note.</div>
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Being present: Measures that capture how much assistance physicians receive from staff with EHR documentation, order entry, and chart review. The goal of these metrics would be to show how much personal attention physician can give patients during visits.</div>
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Fair pay: Measures of how much uncompensated EHR work physicians currently need to do. This category includes answering patient emails, providing medication refills, and managing patient-generated health data.</div>
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Regulatory balance: Measures of pay-for-performance-related EHR clicks and billing-related EHR documentation.</div>
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The proposed metrics "will help capture facilitators of and impediments to professional fulfillment," Dr DiAngi and colleagues write. The data might be used, they said, to help researchers identify how EHR interaction affects care delivery and patient outcomes. In addition, they said, the information could help administrators and clinicians work together to increase professional satisfaction.</div>
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In the view of the coauthors, health system leaders, along with other stakeholders such as regulators, payers, and EHR vendors, are obligated to provide clinicians with "adequate support and usable tools" to avoid physician burnout.</div>
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Why should health IT developers want to rewrite their programs to include the proposed metrics? "Health professional burnout is a public health crisis," coauthor Christine Sinsky, MD, vice president of professional satisfaction for the American Medical Association, told <i style="box-sizing: border-box;">Medscape Medical News</i>. "It is incumbent upon vendors to care about the well-being of the user."</div>
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If the metrics were imbedded in EHRs, the data from them could eventually be made public on a voluntary basis, Dr Sinsky said. The comparisons between the users of different EHRs might prompt design improvements to increase the usability of these systems, she suggested. Comparing the data from different instances of the same EHR might show how EHR implementation affects usability and the burden on clinicians.</div>
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Difficulties in Measuring EHR Effect</h3>
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Charles Kilo, MD, who formerly led the Institute of Healthcare Improvement's practice redesign project and who now practices part time at Greenfield Health in Portland, Oregon, told <i style="box-sizing: border-box;">Medscape Medical News</i> that he is not sure whether the measures proposed in the commentary are a good idea. "You don't measure something unless you're going to do something about it," he said, and the suggested metrics are neither specific enough nor attributable enough to prompt positive remedies.</div>
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Some of the proposed measures, noted Dr Kilo, who until recently was chief medical officer and vice president for quality at Oregon Health & Science University in Portland, concern issues that are under a vendor's control, and others are under an institution's or a clinic's control. Even the number of clicks required to complete a particular task can be at least partly determined by a health system's IT staff, which is able to customize most EHRs, he noted. So comparing the performance of users of different EHRs would be a real challenge.</div>
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Moreover, Dr Kilo said, "It's not so easy to draw a straight line between EHRs and physician dissatisfaction, because there are many other drivers of dissatisfaction" in healthcare. Despite the benefits of EHRs, including the ability to prescribe directly from the exam room and the ability to review labs in real time, for example, "the EHR is in many ways the whipping boy for just so much dissatisfaction with what's going on in healthcare," he said.</div>
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Although he did not dispute the commentary's contention that EHRs can reduce productivity and force physicians to take work home regularly, he said that many other factors must be considered, including a physician's practice patterns and personal efficiency, the way his or her organization set up the EHR, and how the practice has organized its care teams.</div>
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Dr Kilo was intrigued by the suggestion that measuring the amount of time that physicians and other care team members spend on routine tasks might indicate how much work physicians were doing that could be delegated to other clinicians. Most organizations that have care teams cannot measure how well they are performing, he said. "An EHR could be a new tool to measure that. It's worth validating, and I'd like to see some studies validate that."</div>
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<i style="box-sizing: border-box;">The authors and Dr Kilo have disclosed no relevant financial relationships.</i></div>
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<i style="box-sizing: border-box;"><i style="box-sizing: border-box;">Ann Intern Med</i><span style="font-style: normal;">. Published online October 10, 2017. </span><a href="https://www.medscape.com/viewarticle/commentary%20http://annals.org/aim/article/2657167/novel-metrics-improving-professional-fulfillment" style="box-sizing: border-box; color: #5757a6; font-style: normal; text-decoration-line: none;">Abstract</a></i></div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-38580767602895349862017-10-20T05:02:00.003-07:002017-10-20T05:02:27.373-07:00Opioids Top List of Malpractice Claims Linked to Medications<div dir="ltr" style="text-align: left;" trbidi="on">
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Opioid analgesics have a way of getting physicians as well as patients into trouble.</div>
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These painkillers account for more medical-malpractice claims related to drug errors than any other drug class, according to a new study released today by the medical liability insurer Coverys that illustrates the far-reaching effects of the opioid abuse epidemic. The company analyzed more than 10,000 closed malpractice claims from 2012 through 2016.</div>
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Twenty-four percent of medication-related claims involved opioids, even though these drugs accounted for only about 5% of prescription drugs dispensed in 2016, according to published data from QuintilesIMS, a firm that tracks pharmaceutical activity. The next riskiest drug class identified by Coverys was anticoagulants, at 14% of medication-related claims.</div>
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In claims involving opioids, "overdoses are primarily what we see," said study coauthor Robert Hanscom, vice president of business analytics at Coverys. Some claimants also alleged that they became addicted to painkillers. In more than a third of the opioid-related claims, the mistake occurred during the follow-up phase of prescribing.</div>
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"Physicians continued to renew prescriptions without monitoring patients to see if they were getting better or not, if there were any changes in their clinical status," Hanscom told <em style="box-sizing: border-box;">Medscape Medical News</em>. "If patients are still in pain, that's a red flag. It's not helpful to keep prescribing the same opioid if they're not improving."</div>
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In 15% of the opioid-related claims, the physician allegedly "behaved in an inappropriate way," the report stated. Hanscom said this charge usually boiled down to the physician caving into the requests of persuasive, pill-seeking patients against his or her better judgement.</div>
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Anticoagulants join opioid analgesics to constitute the "dangerous duo" in the Coverys study. The biggest pitfall for anticoagulants turns out to be computational and prescribing errors, implicated in 32% of the claims. On-the-money dosing is crucial, said Hanscom, particularly when it comes to "translating blood thinners into the pediatric world." Another risk is when clinicians take patients off anticoagulants for a surgical procedure, supposedly on a temporary basis, but fail to resume this therapy afterward or don't resume it quickly enough.</div>
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<span style="box-sizing: border-box;">"The Biggest Surprise Is That We Haven't Seen More Progress"</span></h3>
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Medication-related errors and liability were the root cause for 8% of all malpractice claims in the Coverys study, putting it in fourth place behind medical mismanagement (14%), surgical and procedural errors (24%), and diagnostic errors (32%). Hanscom said the role played by drugs has diminished somewhat from what it was 15 years ago, when it accounted for 12% to 15% of all claims. However, he anticipated that it would have been lower than 8% in his company's new study.</div>
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The rise of electronic health record and computerized physician order entry systems in recent years raised hopes of significantly reducing medication errors, Hanscom explained. "The biggest surprise is that we haven't seen more progress."</div>
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The shift of patient care from hospitals to ambulatory settings may have blunted the positive impact of information technology because the outpatient world tends to be less computerized, he said. In addition, packed schedules in physician offices aren't conducive to safe prescribing.</div>
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"They're pushing patients through very, very fast," said Hanscom. "The days when you could sit down with a patient for 30 to 45 minutes and make sure you understood everything about him are really gone."</div>
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<em style="box-sizing: border-box;">Follow Robert Lowes on Twitter<span> </span><a href="https://twitter.com/lowesrobert" style="box-sizing: border-box; color: #5757a6; text-decoration: none;">@LowesRobert</a></em></div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-27171720419242373072017-10-20T04:57:00.004-07:002017-10-20T04:57:55.744-07:00'Alarming' Increase in Stroke Risk Factors<div dir="ltr" style="text-align: left;" trbidi="on">
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Despite many prevention initiatives, the prevalence of conventional stroke risk factors, including hypertension, diabetes, dyslipidemia, drug abuse, and smoking, actually appears to be on the rise among new ischemic stroke patients in the United States, a new study shows.</div>
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Other vascular conditions, such as chronic renal failure, coronary artery disease, and carotid stenosis, also appear to be increasing in the acute ischemic stroke population.</div>
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These observations come from a new analysis of data from the Nationwide Inpatient Sample, which includes 922,451 hospitalizations for acute ischemic stroke. The authors say this represents "the most comprehensive assessment to date of temporal trends in the prevalence of major stroke risk factors."</div>
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The study was <a href="http://www.neurology.org/content/early/2017/10/11/WNL.0000000000004617.abstract" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">published online</a> in <em style="box-sizing: border-box;">Neurology</em> on October 11.</div>
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"Our data show that all risk factors increased from 2004 to 2014 and the prevalence of raised cholesterol more than doubled during this time. These are truly alarming findings," lead author, Fadar Oliver Otite, MD, University of Miami Miller School of Medicine, Florida, told <em style="box-sizing: border-box;">Medscape Medical News</em>.</div>
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"While we are putting a great deal of effort into trying to control cardiovascular risk factors, this is not adequate. We need more coordinated strategies to try and tackle this problem," he added.</div>
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However, an <a href="http://www.neurology.org/content/early/2017/10/11/WNL.0000000000004636.short" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">accompanying editorial</a> points out some limitations of the study and cautions against interpreting the data at face value. </div>
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Results of the study show that across the 2004–2014 period, 92.5% of patients with acute ischemic stroke had one or more risk factors. Overall the age- and sex-adjusted prevalence of hypertension was 79%; diabetes, 34%; dyslipidemia, 47%; smoking, 15%; and drug abuse, 2%. In addition, 13% of patients had carotid stenosis, 12% had chronic renal failure, and 27% had coronary artery disease.</div>
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The analysis suggested that during the study period the prevalence of hypertension increased annually by 1.4%, diabetes by 2%, dyslipidemia by 7%, smoking by 5%, and drug abuse by 7%. Prevalence of chronic renal failure increased annually by 13%, carotid stenosis by 6%, and coronary artery disease by 1%.</div>
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During the whole 10 years of the study, diabetes prevalence increased from 30.7% in 2004 to 37.5% in 2014 in all patients, with higher rates in Hispanics and blacks than in whites. By 2014, 50% of Hispanic participants with acute ischemic stroke had diabetes. Stroke admissions with both hypertension and diabetes increased from 25.1% in 2004 to 34.2% in 2014.</div>
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Overall dyslipidemia prevalence more than doubled during the study period — from 28.9% in 2004 to 58.6% in 2014. Admissions with concomitant hypertension, diabetes, and dyslipidemia increased by more than 200% from 9.4% in 2004 to 23.7% in 2014.</div>
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In terms of other vascular diseases, chronic renal failure saw the largest increase — from 4.8% in 2004 to 15.0% in 2014.</div>
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"These results indicate that modifiable stroke risk factors continue to pose significant challenges for AIS [acute ischemic stroke] prevention in the United States and call for intensification of proven treatment strategies and development of novel comprehensive preventive approaches," the researchers write.</div>
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Noting that many of the risk factors are higher in blacks and Hispanics, they suggest that "specific interventions targeting these underrepresented populations may potentially yield major gains for ischemic stroke prevention."</div>
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They further point out that fewer than half of patients with dyslipidemia are receiving treatment for this condition and only around 30% have control of their low-density lipoprotein cholesterol. And up to half of the 75 million patients with hypertension in the United States have uncontrolled blood pressure and about 20% of patients with diabetes have hemoglobin A1c levels more than 9.0 mg/dL.</div>
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"Focusing on risk factor control is critical for stroke prevention," they conclude. "Our alarming findings support the call for further concerted action from all stakeholders to more effectively implement evidence-based interventions to reduce stroke risk."</div>
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But in the accompanying editorial, Shyam Prabhakaran, MD, points out that these new data contrast with other those from studies from Norway and the United Kingdom that found reductions in most stroke risk factors between 1995 and 2011.</div>
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He suggests that the Nationwide Inpatient Sample has several limitations that make it a suboptimal dataset from which to make epidemiologic inferences, including nonstandardized definitions of risk factors across hospitals, potential for coding errors and misclassification of risk factors, and changing definitions of various conditions during the study period.</div>
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He also notes that the lack of data on risk factor management and control "provides little insight on whether risk factors are simply accumulating unbeknownst to patients and therefore untreated, or whether they are being screened for, diagnosed early, and treated appropriately.</div>
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"Thus, instead of a national crisis of increasing risk factors among stroke patients, these same data could imply improved screening and diagnosis of multiple stroke risk factors prior to or at the time of stroke occurrence."</div>
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In addition, Dr Prabhakaran makes the point that an increasing prevalence of risk factors may also be explained by the declining cardiovascular and stroke mortality because more people with multiple risk factors survive longer.</div>
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"So, while there should indeed be a call to action to prevent stroke and its negative consequences on society, we should acknowledge important progress that has been made in stroke prevention, even if there is much more work to be done," he concludes.</div>
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"We should also continue to search for data that measure the health of our society, but remain cautious in interpreting them in a vacuum or without the appropriate context."</div>
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<em style="box-sizing: border-box;">Dr Otite has disclosed no relevant financial relationships.</em></div>
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<em style="box-sizing: border-box;">Neurology</em>. Published online October 11, 2017. <a href="http://www.neurology.org/content/early/2017/10/11/WNL.0000000000004617.abstract" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">Abstract</a>, <a href="http://www.neurology.org/content/early/2017/10/11/WNL.0000000000004636.short" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">Editorial</a></div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-44036888076149362082017-10-20T04:56:00.001-07:002017-10-20T04:56:03.887-07:00High Prevalence Rates for Oral HPV Infection in US Men<div dir="ltr" style="text-align: left;" trbidi="on">
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High prevalence rates of oral human papillomavirus (HPV) of any type, as well as high-risk, oncogenic HPV types, are being reported among all ethnic groups of men in the United States, according to a comprehensive analysis of the National Health and Nutrition Examination Survey (NHANES) from 2011 to 2014.</div>
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Among a sample of 4493 men and 4641 women, the prevalence of any type of oral HPV infection was 11.5% among men and 3.2% among women.</div>
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This means that 11 million men and 3.2 million women in the United States are infected with some type of oral HPV, the study authors point out.</div>
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Disturbingly, however, the prevalence of high-risk oral HPV infection was 7.3% among men and 1.4% among women.</div>
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This translates into 7 million men and 1.4 million women who have high-risk oral HPV infection. By far the most common type is HPV 16, which is commonly associated with oropharyngeal cancer.</div>
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Such risk factors as having more than 16 lifetime sexual partners, smoking, and marijuana use significantly increased the risk of men and women having any as well as high-risk oral HPV infection.</div>
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Just as dramatically, men with concurrent genital as well as any or high-risk oral HPV infection had among the highest prevalence rates of oral HPV infection of any subgroup analyzed.</div>
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The study was <a href="http://annals.org/aim/article/2657698/oral-human-papillomavirus-infection-differences-prevalence-between-sexes-concordance-genital" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">published online</a> October 16 in <em style="box-sizing: border-box;">Annals of Internal Medicine.</em></div>
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"Overall prevalence of oral HPV infection was high among U.S. men," the authors comment.</div>
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"We previously used the <a href="https://academic.oup.com/cid/article-abstract/64/10/1360/2999730/Prevalence-and-Risk-of-Penile-Human-Papillomavirus" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">latest NHANES data</a> to study the prevalence of genital HPV among US men, and we found that one out of two US men have genital HPV and one out of three US men have high-risk genital HPV — findings which were shocking to us — so we wanted to look at the prevalence of oral HPV among these men because we thought they might be at high risk for having oral HPV infection as well," senior author, Ashish Deshmukh, PhD, MPH, University of Florida, Gainesville, told <em style="box-sizing: border-box;">Medscape Medical News</em>.</div>
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"In this study, we found that the prevalence of overall oral HPV among men who have genital HPV was close to 20%, while the prevalence of high-risk HPV infection was close to 14%, whereas the prevalence of oral HPV infection was less than 5% in men without genital infection," he added.</div>
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"To me, this is important because this helps us understand HPV transmission dynamics and it also might help us stratify individuals with a higher prevalence of oral HPV and if we develop potential screening tools [for oral HPV] in the future, these are the men we need to target," Dr Deshmukh said.</div>
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NHANES involved US citizens aged 18 to 69 years who underwent a physical exam at a mobile examination center (MEC).</div>
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A dental hygienist collected oral rinse specimens, which were transferred to a MEC laboratory.</div>
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Each oral rinse sample was analyzed by polymerase chain reaction assay for the presence of any of 37 HPV types.</div>
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"Notably, the prevalence of HPV 16, the most common [high-risk] type, was sixfold higher among men (1.8%)…than women (0.3%) (<em style="box-sizing: border-box;">P</em> < 0.001)," the investigators report.</div>
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Indeed, men were consistently more likely than women to be infected with all high-risk as well as all low-risk HPV types, they add.</div>
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Non-Hispanic black men had the highest prevalence rates of overall oral HPV infection, at 15.8%, as well as high-risk oral HPV infection, at 8.8%.</div>
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Respective prevalence rates in white men were 11.7% for overall oral HPV infection and 7.8% for high-risk oral HPV infection.<br style="box-sizing: border-box;" />Rates were lowest among Hispanic men, at a prevalence of 9.9% for overall oral HPV infection and 5.5% for high-risk oral HPV infection. </div>
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However, the prevalence of overall and high-risk HPV oral infection was significantly influenced by behavioral factors, such as smoking and marijuana use.</div>
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Among men who smoked more than 20 cigarettes a day, the prevalence of overall oral HPV infection was 23.6% while the prevalence of high-risk oral HPV infection was 15% in the same group of men.</div>
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In comparison, among men who had never smoked or who had quit smoking, the prevalence of any oral HPV type infection was 8.3% while the prevalence of high-risk oral HPV infection was 5.4%.</div>
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Moreover, the prevalence of high-risk oral HPV infection was 4 to 10 times higher in men who reported having more than 16 lifetime sexual partners compared with men who reported only one or no lifetime sexual partners.</div>
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Prevalence rates of oral HPV infection were slightly lower but similar among women who reported the same number of lifetime sexual partners.</div>
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Men in particular, but women as well, who reported same-sex partners were also at fairly substantial risk for infection with high-risk oral HPV types: 12.7% and 3.6%, respectively.</div>
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"The prevalence of high-risk HPV infection was highest (22.2%)…among men who reported having 2 or more lifetime same-sex oral sex partners," the investigators note.</div>
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The overall prevalence of oral HPV infection in men who reported having sex with men was 18.2%.</div>
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<span style="box-sizing: border-box;">Persistent Infection</span></h3>
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Asked by <em style="box-sizing: border-box;">Medscape Medical News</em> whether most HPV infections aren't relatively rapidly cleared by the body, Dr Deshmukh acknowledged that most of the common HPV types are not harmful and are likely to be cleared after infection, but HPV16 in particular is much more likely to persist than even other high-risk HPV types.</div>
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In a <a href="https://www.ncbi.nlm.nih.gov/pubmed/25575501" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">study</a> analyzing the persistence of HPV 16, investigators found that most prevalent infections, though not newly acquired infections, persisted for at least 24 months.</div>
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"If a person has more than 16 lifetime sexual partners, then they have a high risk of acquiring HPV 16 but we also have some evidence that these individuals may not clear HPV 16 as fast, so that they are at risk for it to persist," Dr Deshmukh explained.</div>
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Dr Deshmukh also pointed out that HPV 16 was most prevalent in men aged 50 to 69 years, none of whom — and most likely, their sexual partners — would have been vaccinated against HPV infection.</div>
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This is again an important observation as a subanalysis of the current cohort indicated that men who reported being vaccinated against HPV had the lowest prevalence of oral HPV infection of any of the subgroups analyzed.</div>
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Interestingly, study authors also found that rates of oropharyngeal cancer appear to be declining among women, mirroring rates of decline in the incidence of cervical cancer among US women.</div>
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Between 2008 and 2012, an average of almost 40,000 HPV-related cancers were diagnosed in the United States each year, the most common being oropharyngeal squamous cell carcinoma: Over 12,000 cases occurred in men and 3100 cases were diagnosed in women.</div>
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<em style="box-sizing: border-box;">The study was supported by the National Cancer Institute. Dr Deshmukh has disclosed no relevant financial relationships, but some co-investigators have disclosed relationships, stated in the published paper.</em></div>
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<em style="box-sizing: border-box;">Ann Intern Med. </em>Published online October 16, 2017. <a href="http://annals.org/aim/article/2657698/oral-human-papillomavirus-infection-differences-prevalence-between-sexes-concordance-genital" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">Abstract</a></div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-18746493545433807662017-10-20T04:54:00.004-07:002017-10-20T04:54:34.351-07:00Eating More Nuts Could Protect Against Type 2 Diabetes<div dir="ltr" style="text-align: left;" trbidi="on">
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Eating a diet rich in omega-6 polyunsaturated fatty acids (PUFAs), which are found in soybean and sunflower oils, as well as in nuts, may protect against the development of type 2 diabetes, say an international team of researchers.</div>
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Pooling data on levels of linoleic acid and its metabolite arachidonic acid in almost 40,000 individuals from 10 countries, they found that those with the highest linoleic acid levels had a 35% reduction in the risk of developing type 2 diabetes compared with those with the lowest levels.</div>
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The research was <a href="http://www.thelancet.com/journals/landia/article/PIIS2213-8587(17)30307-8/fulltext" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">published online</a> in <i style="box-sizing: border-box;">Lancet Diabetes & Endocrinology</i> on October 11.</div>
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The results indicate that a "simple change in diet" may help protect against type 2 diabetes, said lead author Jason HY Wu, PhD, the George Institute for Global Health, University of New South Wales, Sydney, Australia, in a press <a href="https://www.eurekalert.org/pub_releases/2017-10/gifg-ofm101017.php" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">release</a> from his institution.</div>
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Current US guidelines recommend that between 5% and 10% of energy consumption come from linoleic acid. However, it has been suggested that this may be harmful either because it competes with omega-3 PUFAs or due to potential harmful effects of arachidonic acid.</div>
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Dr Wu acknowledges that some scientists have theorized that omega-6 is harmful to health. "But based on this large global study, we have demonstrated little evidence for harms and indeed found that the major omega-6 fat is linked to lower risk of type 2 diabetes."</div>
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Dariush Mozaffarian, MD, Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts, who was senior author on the paper, added: "This is striking evidence."</div>
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"The people involved in the study were generally healthy and were not given specific guidance on what to eat. Yet those who had the highest levels of blood omega-6 markers had a much lower chance of developing type 2 diabetes."</div>
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<span style="box-sizing: border-box;">Linolenic-Acid Levels Inversely Associated With Type 2 Diabetes Risk</span></h3>
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Noting a recent meta-analysis indicating that total PUFA consumption improves both glycemia and insulin resistance (<em style="box-sizing: border-box;">PLOS Med</em>. 2016; DOI:<a href="http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002087" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">10.1371/journal.pmed.1002087</a>), the team conducted a search of the MEDLINE database and relevant reference lists for studies published on the impact of linoleic acid and arachidonic acid levels on the risk of incident type 2 diabetes.</div>
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They contacted the authors of the 26 prospective cohort studies identified by the search, of whom 20 agreed to take part in a harmonized, individual-level analysis. This yielded a total of 39,740 adults from 20 cohorts in the United States, Iceland, the Netherlands, Germany, Finland, the United Kingdom, Sweden, France, Australia, and Taiwan, none of whom had type 2 diabetes at baseline.</div>
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Biomarkers were sampled between 1970 and 2010 from phospholipids, total plasma or serum, cholesterol esters, and/or adipose tissue, with measurements performed in more than two lipid compartments in six cohorts.</div>
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The mean patient age ranged from 49 to 76 years, and the mean body mass index (BMI) ranged from 23.3 kg/m<sup style="box-sizing: border-box; font-size: 0.85em; line-height: 1;">2</sup> to 28.4 kg/m<sup style="box-sizing: border-box; font-size: 0.85em; line-height: 1;">2</sup>.</div>
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Over 366,073 person-years of follow-up, 4347 individuals developed type 2 diabetes.</div>
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Multivariate analysis of the pooled data indicate that linoleic-acid levels were inversely associated with the risk of developing incident type 2 diabetes on continuous analyses, at a risk ratio per interquintile range of 0.65 (<i style="box-sizing: border-box;">P </i>< .001), and moderate heterogeneity (<i style="box-sizing: border-box;">P </i>= .002).</div>
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The team notes that the findings were generally similar across different lipid compartments, including phospholipids, plasma, cholesterol esters, and adipose tissue.</div>
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In contrast, levels of arachidonic acid were, overall, not significantly associated with the risk of developing type 2 diabetes, at a risk ratio per interquintile range of 0.96 (<i style="box-sizing: border-box;">P </i>= .38; <i style="box-sizing: border-box;">P</i> heterogeneity < .0001).</div>
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An exception was seen, however, for arachidonic acid levels in total plasma, at a risk ratio of 0.73 (<i style="box-sizing: border-box;">P </i>= .0003).</div>
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The analysis also demonstrated that the findings were not significantly affected by taking into account potential confounding factors, such as age, BMI, sex, race, aspirin use, omega-3 PUFA levels, or variants in the fatty-acid desaturase (<i style="box-sizing: border-box;">FADS</i>) gene, which is strongly associated with omega-6 PUFA levels.</div>
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<span style="box-sizing: border-box;">A "Step Forward" for Linoleic Acid and "</span> <span style="box-sizing: border-box;">Reassuring" Data on Arachidonic Acid</span></h3>
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The team says: "The prevalence of type 2 diabetes is escalating rapidly around the world, so identification of dietary and other modifiable risk factors for the prevention of the disease is of clinical, scientific, and public-health importance."</div>
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They continue: "Our analysis provides novel findings that, when combined with in vitro experimental and shorter-term interventions for metabolic risk factors, suggest that linoleic acid has an additional role for prevention of type 2 diabetes in healthy populations."</div>
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In addition, "our findings do not corroborate concerns about potential harmful effects of arachidonic acid."</div>
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In an <a href="http://www.thelancet.com/journals/landia/article/PIIS2213-8587(17)30322-4/fulltext" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">accompanying</a> comment, Gabriele Riccardi, MD, department of clinical medicine and surgery, Federico II University, Naples, Italy, says that the findings represent "a step forward" in the evidence supporting the idea that linoleic acid protects against type 2 diabetes.</div>
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He notes: "Although this finding cannot immediately be extrapolated to linoleic-acid intake, it seems reasonable to assume that the differences in the linoleic-acid biomarker associated with this outcome would be consistent with linoleic-acid intake corresponding to one serving of nuts or one spoonful of sunflower or corn oil daily.</div>
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"Epidemiological studies have shown that this amount of linoleic acid is associated with a reduced risk of type 2 diabetes."</div>
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Moreover, given the previous concerns over whether arachidonic acid may cause harmful effects, Dr Riccardi describes the finding that arachidonic-acid biomarkers are not associated with increased type 2 diabetes risk as "reassuring in view of the potential implications for dietary advice."</div>
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"Altogether, the outcomes of the study by Wu and colleagues are fully concordant with a nested case-cohort analysis of the European EPIC cohort [<i style="box-sizing: border-box;">PLOS Med</i>. 2016; DOI:<a href="http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002094" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">10.1371/journal.pmed.1002094</a>]. Together, these studies indicate that the association between higher linoleic-acid biomarkers and reduced risk of type 2 diabetes does not represent a chance finding.</div>
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"The effect of dietary linoleic acid on diabetes incidence should now be tested in a randomized, controlled intervention trial," he concludes.</div>
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<i style="box-sizing: border-box;">Cohorts within the Fatty Acids and Outcomes Research Consortium received direct funding from a number of sources. Unilever also provided Tufts University (Massachusetts) with a restricted grant to partly support the analysis. Dr Wu received research grants from Unilever for this study. Dr Mozaffarian received ad hoc honoraria and consulting fees from the Life Sciences Research Organization, AstraZeneca, Boston Heart Diagnostics, Global Organization for EPA and DHA Omega-3, DSM, Nutrition Impact, the Haas Avocado Board, and Pollock Communications; and chapter royalties from UpToDate. Disclosures for the coauthors are listed in the paper. Dr Riccardi has no relevant financial relationships.</i></div>
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<i style="box-sizing: border-box;">Lancet Diabetes Endocrinol. </i>Published online October 11, 2017. <a href="http://www.thelancet.com/journals/landia/article/PIIS2213-8587(17)30307-8/fulltext" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">Article</a>, <a href="http://www.thelancet.com/journals/landia/article/PIIS2213-8587(17)30322-4/fulltext" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">Editorial</a></div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-52038860096887580332017-10-20T04:53:00.003-07:002017-10-20T04:53:16.931-07:00Opioids for C diff Pain Connected to Worse Outcomes<div dir="ltr" style="text-align: left;" trbidi="on">
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ORLANDO — For patients infected with <i style="box-sizing: border-box;">Clostridium difficile</i>, significant opioid use appears to be associated with increases in the severity of infection and in-hospital mortality, new research suggests.</div>
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"As physicians, when we see someone in pain, we often will default to opioids. This study raises awareness that, in <i style="box-sizing: border-box;">C difficile </i>patients in particular, opioids should be avoided," said Elizabeth John, MD, from Rutgers University in New Brunswick, New Jersey.</div>
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Opioid use has not been typically associated with <i style="box-sizing: border-box;">C difficile</i> infection. However, in a preliminary study, Dr John and her colleagues found an association between opioid use, longer hospital stays, and higher white blood cell counts in infected patients (<i style="box-sizing: border-box;">Gastroenterology</i>. <a href="http://www.gastrojournal.org/article/S0016-5085(17)31422-1/abstract" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">2017;5[Suppl 1]:S347</a>).</div>
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In a follow-up study, which Dr John presented here at the World Congress of Gastroenterology 2017, the researchers reviewed the medical records of 302 adults with clinically diagnosed <i style="box-sizing: border-box;">C difficile</i> infection. All patients were hospitalized for a minimum of 3 days.</div>
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Patients who were dispensed a morphine-equivalent dose of an opioid of at least 10 mg during their hospital stay were assigned to the opioid group. All other patients served as the control group. Regression analyses controlled for the previous use of antibiotics, the use of acid suppressive medication, the source of infection (hospital vs community), comorbidities, and demographic characteristics.</div>
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Severe or complicated <i style="box-sizing: border-box;">C difficile</i> infection was more common in the opioid group than in the control group. And the rate of complicated infection alone was higher in the opioid group.</div>
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Average hospital stay was longer in the opioid group than in the control group (25 vs 15 days; adjusted incidence rate ratio, 1.46; <i style="box-sizing: border-box;">P</i> = .03). And the in-hospital mortality rate was higher in the opioid group.</div>
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<span style="box-sizing: border-box; font-family: proxima_nova_ltlight, sans-serif;">Now I know we are on to something.</span></div>
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"I was surprised by how strong the findings were," Dr John told <i style="box-sizing: border-box;">Medscape Medical News. </i>"They make sense to me, but after seeing them validated in a large sample population, now I know we are on to something."</div>
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Because opioids are known to slow the gastrointestinal tract, they might increase the absorption of <i style="box-sizing: border-box;">C difficile</i> bacterial toxins, she suggested.</div>
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"Given the opioid abuse epidemic, this study highlights another reason for patients and their healthcare providers to carefully consider alternative agents to opioids," Keith Obstein, MD, from Vanderbilt University in Nashville, Tennessee, said when asked to comment by <i style="box-sizing: border-box;">Medscape Medical News</i>.</div>
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<i style="box-sizing: border-box;">Dr John and Dr Obstein have disclosed no relevant financial relationships.</i></div>
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World Congress of Gastroenterology 2017: Poster P103. Presented October 15, 2017.</div>
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<i style="box-sizing: border-box;">Follow Medscape Gastroenterology on Twitter <a href="https://twitter.com/medscapegastro?lang=en" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">@MedscapeGastro</a> and Damian McNamara <a href="https://twitter.com/medreporter" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">@MedReporter</a></i></div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-51419711798808408872017-10-20T04:52:00.002-07:002017-10-20T04:52:14.330-07:00Puerto Rico’s Health Faces Prolonged Recovery<div dir="ltr" style="text-align: left;" trbidi="on">
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As President Donald Trump signals impatience to wind down emergency aid to Puerto Rico, the challenges wrought by Hurricane Maria to the health of Puerto Ricans and the island’s fragile health system are in many ways just beginning.</div>
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Three weeks after that direct hit, nearly four dozen deaths are associated with the storm. But the true toll on Puerto Rico’s 3.4 million residents is likely to involve sickness and loss of life that will only become apparent in the coming months and in indirect ways.</div>
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As victims continue to be found and stranded people reached, it will take time to assess the consequences of their missed care or undertreatment.</div>
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The situation in Puerto Rico’s health system is far more vulnerable than those in Texas or Florida, which also weathered hurricanes this fall — medically, economically and politically. A month after Hurricane Katrina in 2005, only about half of the final official fatalities had been tallied.</div>
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Puerto Rico has a <a href="https://gis.cdc.gov/grasp/diabetes/diabetesatlas.html" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">higher rate of diabetes</a> than any state, according to 2015 data from the U.S. Centers for Disease Control and Prevention. About half of the island’s population depends on Medicaid. And, unlike in the States, Puerto Rico’s Medicaid system receives a fixed amount to meet residents’ needs, a pot of money that could run dry next month, said Jenniffer González-Colón, Puerto Rico’s delegate to Congress.</div>
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“We’ve had a fiscal crisis, a Medicaid funding cliff, Hurricane Irma and Hurricane Maria —we are being hit from every angle,” she said.</div>
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Orlando Gutiérrez, an associate professor of nephrology at the University of Alabama-Birmingham and a board member of the American Kidney Fund, said Puerto Rico is the “perfect storm” for a disaster.</div>
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The Federal Emergency Management Agency has distributed food and water to help stave off disease or dehydration, relief workers have prioritized efforts to get hospitals and other health facilities operating again, and the Navy dispatched the <a href="https://www.navy.com/about/equipment/vessels/hospital-ships.html" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">hospital ship USNS Comfort</a>, which has 250 beds.</div>
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Coordinated efforts to deliver fuel, water and medications to health facilities have allowed some to reopen. As of Oct. 12, federal emergency officials said nearly all Puerto Rican hospitals were open, although some are still dependent on generators. The Puerto Rican government said electricity has been restored to more than half of the hospitals. Nearly all of the dialysis centers are operating now, though many patients have missed treatments.</div>
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But Katia León, deputy director of primary care for the Association of Primary Care in Puerto Rico, said she believes the population’s health has worsened since the storm hit. Cases of diarrhea, pink eye and skin rashes are appearing in larger numbers, she said, and health officials are concerned about infections from contaminated water.</div>
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The potential for outbreaks means it is now more important than ever to keep clinics open, León said, even though the operating costs are likely to be high.</div>
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“We are talking about a situation that is going to continue in the long term … because this is a crisis without precedent,” she said.</div>
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Many residents are still unable to get to clinics or health centers for their chronic health conditions, such as diabetes or heart disease. Diabetes test strips and dialysis equipment have been in short supply since the storm. Patients went days or weeks without medication and treatment. Nutritious food and working refrigerators to store it in are scarce.</div>
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Some medicines are in tight supply or require arduous travel to secure.</div>
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Slow gains to provide electricity threaten patients on dialysis, who rely on power to filter their blood and survive. And mental trauma caused by the storm will linger long after buildings are reconstructed.</div>
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In addition, Puerto Rico was already facing a significant “<a href="https://khn.org/news/exodus-by-puerto-rican-medical-students-deepens-islands-doctor-drain/" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">brain drain</a>,” as many young professionals, including doctors, moved to the U.S. mainland, said Andrew Schroeder, who works for DirectRelief, a private charity that has been coordinating shipments of medical supplies to the island. It will be an uphill battle to persuade these doctors and other health specialists to stay on the island now.</div>
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Hospitals and health clinics are working hard to get back to speed. Eddie Perez-Caban, the executive director of the Camuy Health Services clinic on the western side of Puerto Rico, said he was astonished after making the 25-minute commute through downed wires and fallen electric poles the day after Maria hit. He found a damaged roof, a broken air conditioning system and no electricity or running water — and about 75 of his employees ready to work. Five days later, the clinic opened with running water and AC and light powered by a generator.</div>
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“For so many people to show up — truthfully, it filled me with a lot of satisfaction to work with a group of people that have that commitment to the community and the patients we serve,” he said.</div>
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Republican leaders in the House of Representatives have proposed allotting an additional $1 billion for Puerto Rico’s Medicaid program to resupply its coffers as part of a bill that would extend the Children’s Health Insurance Program. But the legislation has been stalled in committee.</div>
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Puerto Rico’s program is different than those in the States. While states receive open-ended federal funding, Puerto Rico’s annual funding amount is capped — typically at more than $300 million. Nearly half of the island’s residents <a href="https://aspe.hhs.gov/system/files/pdf/255461/PuertoRicoEnrollment_DataPoint.pdf" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">rely on the program for coverage</a>. If the money runs out, as many as 900,000 beneficiaries could lose their health coverage, according to estimates from the Department of Health and Human Services under the Obama administration.</div>
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Another bill under consideration in Congress could offer Puerto Rico millions of dollars in disaster relief, an effort that has broad support. More than 6 in 10 Americans said Puerto Rico isn’t getting all the help it needs yet, and more than half said the emergency response has been too slow, with the federal government not doing enough to restore electricity and access to food and water, <a href="https://www.kff.org/other/poll-finding/puerto-rico-after-hurricane-maria-the-publics-knowledge-and-views-of-its-impact-and-the-response/" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">according to a poll</a> released Thursday by the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)</div>
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In Puerto Rico, most of the roughly four dozen dialysis centers are now seeing patients, though that service is dependent on getting shipments of fuel to power generators and water and dialysis solution for the treatments. Some clinics are shortening their hours and the time of treatment. Instead of four-hour treatments, patients are receiving only three hours of dialysis, which saves on staffing time, supplies and use of generators.</div>
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Mike Spigler, an official with the American Kidney Fund, who is handling some of the emergency response for kidney patients on the island, describes the situation as “tenuous.”</div>
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In the short term, patients can function without dialysis, or with limited treatments. But as time goes on, the risk of heart failure and stroke begins to climb.</div>
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Schroeder also said he is worried about mental health services, which often get lower priority than food and shelter after a storm. He said people are traumatized and, without counseling, anxiety and depression could become major public problems. Multiple news outlets report that two of the island’s 34 total deaths attributed to the hurricane were suicides.</div>
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Older residents of the island are particularly vulnerable to mental trauma in the aftermath of the storm, said José Acarón, the director of the Puerto Rican branch of AARP. Approximately 1.2 million people in Puerto Rico are 50 or older, Acarón said. Many of them live outside of traditional nursing homes or independent living facilities, making them harder to reach.</div>
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“We still have a lot of challenges to overcome before things can go back to normal,” said Acarón. “But a return to normal is not going back to where we were before the hurricane. It’s a new normal.”</div>
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<em style="box-sizing: border-box;">Staff writer Phil Galewitz contributed to this article.</em></div>
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<em style="box-sizing: border-box;"><a href="http://www.kaiserhealthnews.org/" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">Kaiser Health News</a> (KHN) is a national health policy news service. It is an editorially independent program of the <a href="http://www.kff.org/" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">Henry J. Kaiser Family Foundation</a>.</em></div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-30664816428656113692017-10-20T04:50:00.003-07:002017-10-20T04:50:43.298-07:00'Change the Conversation' About Hormone Therapy in Menopause<div dir="ltr" style="text-align: left;" trbidi="on">
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PHILADELPHIA — The new position statement on hormone therapy from the North American Menopause Society is in the public eye here at the 2017 annual meeting, where fears about treatment are being discussed and women and healthcare providers are being reassured that hormone therapy is safe and effective for menopausal symptoms that disrupt a woman's quality of life (<i style="box-sizing: border-box;">Menopause</i>. <a href="https://insights.ovid.com/pubmed?pmid=28650869" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">2017;24:728-753</a>).</div>
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"Fear has been driving the conversation about hormone therapy," said JoAnn Pinkerton, MD, from the Midlife Health Center at the University of Virginia in Charlottesville, who is executive director of NAMS and chair of the 20-member position statement advisory panel.</div>
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But "hormone therapy remains the most effective treatment for vasomotor symptoms and the genitourinary syndrome of menopause, and has been shown to prevent bone loss and fracture," she said.</div>
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Hormone therapy is approved by the US Food and Drug Administration for vasomotor symptoms in women without contraindications; the prevention of bone loss and fractures in postmenopausal women at high risk for osteoporosis or fracture; and premature surgical menopause, hypogonadism, and primary ovarian insufficiency until average menopausal age is reached (as long as there are no contraindications). And for women experiencing only genitourinary menopausal symptoms, low-dose vaginal estrogen therapy is first-line, rather than systemic, therapy.</div>
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Since the 2002 publication of findings from the Women's Health Initiative (WHI), anxiety about risk for breast cancer, heart disease, and dementia have dominated clinical discussions about hormone therapy. However, follow-up data from the WHI, including a study published this year, <a href="https://www.medscape.com/viewarticle/885552" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">as reported</a> by <i style="box-sizing: border-box;">Medscape Medical News</i>, show no increase in cardiovascular, cancer, or all-cause mortality.</div>
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<span style="box-sizing: border-box; font-family: proxima_nova_ltlight, sans-serif;">Fear has been driving the conversation about hormone therapy.</span></div>
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"We really want clinicians to change the conversation with women," Dr Pinkerton told <i style="box-sizing: border-box;">Medscape Medical News</i>. "We want them to feel very comfortable that if a woman is having bothersome menopausal systems — hot flashes, night sweats, sleep disturbances — hormone therapy is safe and effective, primarily for women who are starting hormone therapy if they are under 60 and within 10 years of menopause, where there are more benefits than risks."</div>
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Dr Pinkerton emphasized the differences in risk between estrogen therapy and estrogen with progestin. Estrogen-only therapy, for example, appears to have a better safety profile for longer use.</div>
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This position statement will likely reduce some of the fears women and their clinicians still harbor about hormone therapy, said Mache Seibel, MD, menopause expert and resident trainer at the Beth Israel Deaconess Medical Center in Boston.</div>
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<span style="box-sizing: border-box; font-family: proxima_nova_ltlight, sans-serif;">The pendulum is swinging back in favor of hormone therapy.</span></div>
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"The pendulum is swinging back in favor of hormone therapy," he told <i style="box-sizing: border-box;">Medscape Medical News</i>. And "it helps clear the air in terms of removing fear and confusion about menopause and the appropriateness of considering hormone therapy."</div>
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It typically takes about an hour to consult with patients about menopause because it requires additional time to allay women's fear about hormone therapy, said Dr Seibel, author of <i style="box-sizing: border-box;">The Estrogen Fix</i>, a new book about hormone therapy.</div>
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"The hormone therapy benefits versus risks have been so confusing that the majority of women and many of their doctors still don't accept that the risks are much less than the benefits," he said.</div>
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<span style="box-sizing: border-box;">Benefits and Risks of Therapy</span></h3>
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The effects of hormone therapy vary with a woman's age and time since menopause.</div>
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For cardiovascular disease, there does not appear to be an elevation in risk for women who begin hormone therapy more than 10 or 20 years after menopause, but some data show a reduced cardiovascular risk for younger women.</div>
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A meta-analysis of randomized controlled studies showed that for women who start hormone therapy less than 10 years after the onset of menopause, there is a 48% reduction in the risk for coronary heart disease (relative risk [RR], 0.52; 95% confidence interval [CI], 0.29 - 0.96) and a 30% reduction in the risk for cardiovascular death (RR, 0.70; 95% CI, 0.52 - 0.95) (<i style="box-sizing: border-box;">Cochrane Database Syst Rev</i>. <a href="http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002229.pub4/abstract;jsessionid=AB92F502201F5C1A2F66C6B88B1F20A5.f04t03" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">2015;3:CD002229</a>).</div>
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However, the risk for venous thromboembolism was elevated (RR, 1.74; 95% CI, 1.11 - 2.73). And as women age, the meta-analysis showed a gradual increase in the risk for stroke, venous thromboembolism, and pulmonary embolism.</div>
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The risk for breast cancer related to hormone therapy is more complex, Dr Pinkerton explained. Data are conflicting, and the risk might depend on the type of therapy a woman uses (estrogen alone appears to have a lower risk), dose, duration of use, route of administration, regimen, previous exposure to hormone therapy, and her individual characteristics and risk history.</div>
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In addition, evidence shows that the risk for lung cancer is neutral and the risk for ovarian cancer might be slightly elevated after long-term use. For colon cancer, hormone therapy might protective, although data are limited and observational.</div>
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The position statement addresses special populations: survivors of breast or endometrial cancer, women being treated for endometrial cancer, women older than 65 years, and women who experience early menopause, primary ovarian insufficiency, or who have undergone oophorectomy because of a <i style="box-sizing: border-box;">BRCA</i> mutation.</div>
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The statement also lays out the evidence for hormone therapy related to specific vasomotor symptoms, sleep, endometrial health and protection, sexual function, bone and joint protection, cognition, mood, type 2 diabetes, gallbladder and liver health, and overall quality of life. Systemic therapy reduces night-time awakenings and sleep disruptions and improves sleep duration and cycles, particularly in women experiencing hot flashes.</div>
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In women taking estrogen — alone or with progesterone — there is a 33% reduction in the risk for hip fracture, and less joint pain and stiffness.</div>
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Hormone therapy is also associated with a decreased risk for type 2 diabetes and a potential attenuation of menopausal weight gain. The increase in the risk for gallstones, cholecystitis, and cholecystectomy seen with oral estrogen and estrogen-plus-progesterone therapy is reduced with transdermal hormone therapy.</div>
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Although some trials have suggested improvement in depressive symptoms in perimenopausal women taking hormone therapy, the overall evidence is not sufficient to recommend systemic therapy for the treatment of depression.</div>
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But even if hormone therapy does lead to improvements in mood, women are "more likely to experience a worsening of mood after estrogen withdrawal," Dr Pinkerton pointed out. Similarly, hormone therapy is not recommended for the treatment of dementia or cognitive decline at any age.</div>
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Despite the complexity of the data, women and clinicians have more options than ever when it comes to the type of hormone therapy they receive, the route of administration, and the dosing, Dr Pinkerton pointed out.</div>
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"This therapy can be individualized, and women who take it should not have to have a hard stop," Dr Pinkerton told <i style="box-sizing: border-box;">Medscape Medical News</i>. Older women and their providers should annually revisit whether to continue therapy. "Look at the woman, her risks, and what therapies are out there to determine how long to continue and what's safest for her to take."</div>
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<i style="box-sizing: border-box;">Dr Pinkerton reports receiving research funds through the University of Virginia from TherapeuticsMD for clinical research. Dr Seibel has disclosed no relevant financial relationships.</i></div>
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North American Menopause Society (NAMS) 2017 Annual Meeting. Presented October 11, 2017.</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-34732550920651386922017-10-20T04:48:00.003-07:002017-10-20T04:48:31.452-07:00Kindergarten Vaccination Rates Hold Steady<div dir="ltr" style="text-align: left;" trbidi="on">
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Kindergarten vaccination coverage rates for measles, mumps, and rubella vaccine (MMR); diphtheria, tetanus, and acellular pertussis vaccine (DTaP); and varicella vaccine each approached 95% in the United States, according to the latest data from the Centers for Disease Control and Prevention (CDC).</div>
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The CDC report included 2016 to 2017 MMR, DTaP, and varicella vaccination coverage submitted by immunization programs in 48 states and the District of Columbia. Oklahoma and Wyoming did not report data.</div>
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The median vaccination coverage across the nation for two doses of MMR was 94.0%. The median vaccination rate for the state-required number of doses of DTaP was 94.5%. The median vaccination coverage rate for two doses of varicella vaccine was 93.8%.</div>
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Ranee Seither, MPH, an epidemiologist at the CDC in Atlanta, Georgia, and colleagues report that four states (California, New York, North Dakota, and Tennessee) all experienced increases in coverage of at least 1.5 percentage points for all reported vaccines. The authors <a href="https://www.cdc.gov/mmwr/volumes/66/wr/mm6640a3.htm" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">published</a> their findings in the October 13 issue of <i style="box-sizing: border-box;">Morbidity and Mortality Weekly Report</i>.</div>
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Since the 2011 to 2012 school year, the mean kindergarten exemption rate for MMR vaccination has remained at or below 2%. At this time, "[t]he mean percentage of kindergartners with an exemption from one or more required vaccines...is 2.0%," the authors write. They note that the exemption rate varies a great deal from state to state.</div>
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The median percentage of kindergartners attending school during a grace period or provisional enrollment was 2%, which was the same percentage as in 2015 to 2016.</div>
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Kindergarten Vaccination</h3>
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Experts consider kindergarten vaccination requirements to be an excellent way to ensure children are fully vaccinated with the recommended age-appropriate vaccines. Thus, in an effort to protect students and communities against vaccine-preventable diseases, many state and local school systems require that children be fully vaccinated when they enter kindergarten. School nurses and other school personnel work with federally funded immunization programs to assess vaccination coverage and exemption status of children enrolled in public and private kindergartens.</div>
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States vary with regard to their requirements for vaccination, data collection, and definitions of grace period and provisional enrollment. Most states, however, require vaccination coverage for MMR, DTaP, and varicella.</div>
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Thirty states shared local-level school vaccination coverage. These data revealed that vaccination coverage varied at the local level.</div>
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The authors note that the data collected in their study should allow immunization programs to focus on schools with lower vaccination coverage and higher exemption levels. It should also make it possible for schools to follow up with undervaccinated students in the hopes of protecting them from vaccine-preventable diseases.</div>
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<i style="box-sizing: border-box;">The authors have disclosed no relevant financial relationships.</i></div>
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<i style="box-sizing: border-box;">Morb Mortal Wkly Rep</i>. Published online October 12, 2017. <a href="https://www.cdc.gov/mmwr/volumes/66/wr/mm6640a3.htm" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">Full text</a></div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-74213461671266161612017-10-19T12:28:00.002-07:002017-10-19T12:28:51.339-07:00Insulin Glargine/Breast Cancer Link Seen Again in Type 2 Diabetes<div dir="ltr" style="text-align: left;" trbidi="on">
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In a large observational study, women with type 2 diabetes who received long-acting insulin glargine (<em style="box-sizing: border-box;">Lantus</em>, Sanofi) had a 1.4-fold increased risk of breast cancer compared with women who were given intermediate-acting neutral protamine Hagedorn (NPH) insulin during roughly 4 years and up to 12 years of follow-up.</div>
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In contrast, those who received insulin detemir (<em style="box-sizing: border-box;">Levemir</em>, Novo Nordisk) did not have any increased risk of breast cancer.</div>
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Of note, the breast-cancer signal with insulin glargine was only significant among prior insulin users and not new users.</div>
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And this signal does not mean clinicians should change clinical practice without a review by regulatory agencies, caution the investigators, led by Jennifer W Wu, MD, of McGill University, Montreal, Quebec, who published their paper in the <em style="box-sizing: border-box;">Journal of Clinical Oncology</em>.</div>
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"Despite these findings, the benefits and risk of insulin glargine must be considered by drug regulatory agencies before any changes in clinical practice can be made," they conclude.</div>
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The fact that the increased risk of breast cancer was only seen in women with prior exposure to insulin, "an unusual group of type 2 [diabetes] women," suggests "the safety signals may be nuanced, with specific types of insulin," said Craig Currie, PhD, an epidemiologist from Cardiff University, Wales, who was not involved with the study.</div>
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Nevertheless the "findings add to an increasing body of evidence that questions the safety of insulin in people with type 2 diabetes more generally," he told <em style="box-sizing: border-box;">Medscape Medical News</em> in an email.</div>
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<span style="box-sizing: border-box;">New Study as Long-Acting Insulins Have Been Available for Longer</span></h3>
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The issue of cancer risk associated with insulin, which is a potential growth factor, isn't new and has reared its head before in relation to insulin glargine in particular.</div>
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Several observational studies have looked at whether insulin glargine is associated with an increased risk of breast cancer and have come up with conflicting results, Dr Wu and colleagues explain as background.</div>
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Moreover, in the randomized <a href="https://www.medscape.com/viewarticle/806904" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">Outcomes Reduction Insulin Glargine Intervention</a>(ORIGIN) trial, which had adjudicated cancer outcomes reported in 2013, only roughly 4000 of the 12,500 patients were women, and there were only 56 cases of breast cancer during follow-up, which was "insufficient power for site-specific cancers such as breast and also...too short a follow-up for the necessary latency."</div>
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Thus "to date, the US Food and Drug Administration finds the evidence is inconclusive and suggests that more epidemiologic data are needed," they observe.</div>
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So they aimed to assess the risk of breast cancer with insulin analogs, "now that these insulins have been on the market for a longer time."</div>
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They identified 22,395 women with type 2 diabetes in the UK Clinical Practice Research Datalink (CPRD) who had not been prescribed insulin before age 40, had not had gestational diabetes or any cancer, but had received at least one prescription of insulin glargine, detemir, or NPH during 2002–2012.</div>
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On average, the women received 5.4 to 5.8 insulin prescriptions each year.</div>
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During follow-up, 108 of 9549 women who received NPH, 176 of 9575 women who received insulin glargine, and 37 of 3271 women who received insulin detemir developed breast cancer.</div>
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The incidence rates of breast cancer were 35.1, 48.7, and 14.8 per 1000 person-years for women who received NPH, glargine, and detemir, respectively.</div>
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<span style="box-sizing: border-box;">New Insulin Users Not at Risk?</span></h3>
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Those who received insulin glargine for 5 or more years had a roughly twofold increased risk of breast cancer compared with the reference group (women who received NPH) and women who were switched to insulin glargine from another insulin had an approximately 1.5-fold increased risk of developing breast cancer.</div>
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<span style="box-sizing: border-box; font-family: proxima_nova_rgbold, sans-serif;">Risk of Breast Cancer, Insulin Glargine vs NPH Users*</span></div>
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<table class="inline_data_table" style="border-collapse: collapse; border-spacing: 0px; box-sizing: border-box; margin: 0px 0px 15px; width: 690px;"><tbody style="box-sizing: border-box;"></tbody><tbody style="box-sizing: border-box;" xmlns:dctm="http://www.documentum.com" xmlns:fmt="http://java.sun.com/jstl/fmt" xmlns:jsp="jsp" xmlns:xlink="http://www.w3.org/1999/xlink">
<tr style="box-sizing: border-box;" valign="top"><th style="background-color: #eff3f6; border: 1px solid rgb(216, 216, 216); box-sizing: border-box; font-family: proxima_nova_ltsemibold, sans-serif; font-size: 1rem; font-weight: normal; line-height: 30px; padding: 9px 17px; text-align: left;"><span style="box-sizing: border-box; font-family: proxima_nova_rgbold, sans-serif;">Insulin glargine users</span></th><th style="background-color: #eff3f6; border: 1px solid rgb(216, 216, 216); box-sizing: border-box; font-family: proxima_nova_ltsemibold, sans-serif; font-size: 1rem; font-weight: normal; line-height: 30px; padding: 9px 17px; text-align: left;"><span style="box-sizing: border-box; font-family: proxima_nova_rgbold, sans-serif;">HR (95% CI)</span></th></tr>
<tr style="box-sizing: border-box;" valign="top"><td style="border: 1px solid rgb(216, 216, 216); box-sizing: border-box; font-size: 1rem; line-height: 1.88; padding: 9px 17px;">Overall users</td><td style="border: 1px solid rgb(216, 216, 216); box-sizing: border-box; font-size: 1rem; line-height: 1.88; padding: 9px 17px;">1.44 (1.11–1.85)</td></tr>
<tr style="box-sizing: border-box;" valign="top"><td style="border: 1px solid rgb(216, 216, 216); box-sizing: border-box; font-size: 1rem; line-height: 1.88; padding: 9px 17px;">> 5 y of insulin glargine</td><td style="border: 1px solid rgb(216, 216, 216); box-sizing: border-box; font-size: 1rem; line-height: 1.88; padding: 9px 17px;">2.23 (1.32–3.77)</td></tr>
<tr style="box-sizing: border-box;" valign="top"><td style="border: 1px solid rgb(216, 216, 216); box-sizing: border-box; font-size: 1rem; line-height: 1.88; padding: 9px 17px;">> 30 prescriptions</td><td style="border: 1px solid rgb(216, 216, 216); box-sizing: border-box; font-size: 1rem; line-height: 1.88; padding: 9px 17px;">2.29 (1.26–4.16)</td></tr>
<tr style="box-sizing: border-box;" valign="top"><td style="border: 1px solid rgb(216, 216, 216); box-sizing: border-box; font-size: 1rem; line-height: 1.88; padding: 9px 17px;">Prior insulin users</td><td style="border: 1px solid rgb(216, 216, 216); box-sizing: border-box; font-size: 1rem; line-height: 1.88; padding: 9px 17px;">1.53 (1.10–2.12)</td></tr>
<tr style="box-sizing: border-box;" valign="top"><td style="border: 1px solid rgb(216, 216, 216); box-sizing: border-box; font-size: 1rem; line-height: 1.88; padding: 9px 17px;">New insulin users</td><td style="border: 1px solid rgb(216, 216, 216); box-sizing: border-box; font-size: 1rem; line-height: 1.88; padding: 9px 17px;">1.18 (0.77–1.81)</td></tr>
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*During a mean 4.4-year follow-up; adjusted for age, study entry, alcohol use, smoking, BMI, HbA<sub style="box-sizing: border-box;">1c</sub>, diabetes duration, prior insulin use, duration of insulin use, Charlson comorbidity score, noninsulin diabetic medications, other medications</div>
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The risk of breast cancer was not significantly higher in the insulin detemir group compared with NPH users (HR, 1.17; 95% CI 0.77–1.77). However, this result is somewhat inconclusive due to the smaller number of women using this newer insulin and the shorter time that it has been available, Dr Wu and colleagues write.</div>
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Riccardo Perfetti, MD, PhD, VP for medical affairs diabetes, Sanofi, told <em style="box-sizing: border-box;">Medscape Medical News</em> in an email: "The results of the new-user analysis in this study provided additional evidence that [in new users] insulin glargine is not associated with an increased risk of breast cancer, even for exposure longer than 5 years."</div>
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However, Dr Wu and colleagues note that among new users, the upper limit of the confidence interval was 1.81 (meaning that some of the women had this increased risk), and the numbers may have been too small to detect risk, since few women in the comparator NPH group (< 30%) were new insulin users.</div>
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<span style="box-sizing: border-box;">Too Much Confounding? Weak Signal With No Cause for Concern</span></h3>
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The new trial is "interesting, but I don't think it can rule out confounding," lead author of the ORIGIN trial, Hertzel C Gerstein, MD, from McMaster University, in Hamilton, Ontario, who was not involved with the current study, told <em style="box-sizing: border-box;">Medscape Medical News</em>.</div>
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"Is it the insulin, or somehow the type of person who was prescribed glargine was different from the type of person who was prescribed NPH or detemir? We don't know," he said.</div>
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Also, the study did not adjust for age at menarche and menopause, parity, age at first birth, breast feeding, "and in particular, family history of breast cancer," Dr Perfetti stressed.</div>
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The researchers acknowledge that unaccounted-for confounders might explain some of the findings. "However, this is unlikely because only a strong unmeasured confounder, with major imbalance between insulin glargine and NPH, would be needed to bias the hazard ratio."</div>
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Nevertheless, "I would not say that this study raises any real concern in my mind," Dr Gerstein said, noting it was an observational study with a weak signal.</div>
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"If it were a strong risk relationship, fivefold, 10-fold, then we'd be having a different discussion."</div>
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"In the International Epidemiology Study and the ORIGIN trial, a total of 1,595,400 person-years of exposure to insulin were evaluated, and no association with cancer has been found," Dr Perfetti pointed out.</div>
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<span style="box-sizing: border-box;">Upcoming Study From US Databases</span></h3>
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"Moreover," Dr Perfetti added, "new results, currently in press, assessing the risk of breast cancer in women treated with insulin glargine and human NPH insulin in new users and all-users on two large US database, analyzing ~300,000 patients over 12 years...show that glargine was not associated with an increased risk of breast cancer compared with NPH for long-term exposure."</div>
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But according to Dr Currie, to truly resolve the question of whether insulin glargine increases the risk of breast cancer "would require a trial of analogue basal insulins vs alternative insulin regimens vs non-insulin glucose-lowering medications."</div>
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<em style="box-sizing: border-box;">The study was partly funded by the Canadian Institutes of Health Research and the Canadian Foundation for Innovation. Dr Wu was a recipient of a Canadian Institutes of Health Research Doctoral Research award at the time the study was being conducted. Disclosures for the coauthors are listed in the paper. Dr Currie has no relevant financial relationships. Dr Gerstein has received research grant support from Sanofi, Lilly, AstraZeneca and Merck, and honoraria for speaking or consulting from Sanofi, Novo Nordisk, Lilly, Boehringer Ingelheim, AstraZeneca, Merck, and Abbott.Sanofi sponsored the ORIGIN trial.</em></div>
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<em style="box-sizing: border-box;">J Clin Oncol</em>. Published online September 27, 2017. <a href="http://ascopubs.org/doi/abs/10.1200/JCO.2017.73.4491?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed&" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">Abstract</a></div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-38895098890371987592017-10-19T12:27:00.002-07:002017-10-19T12:27:21.115-07:00FDA Urges Clinicians to Help Limit Opioid Prescriptions<div dir="ltr" style="text-align: left;" trbidi="on">
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WASHINGTON ― US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, said the agency wants to find ways to limit both the number of opioid prescriptions and the duration of those prescriptions and is asking healthcare providers to step up and support this effort.</div>
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"Some limits on duration of use are an inevitability," said Dr Gottlieb, who spoke at a special session of the <a href="https://nam.edu/event/annual-meeting-2017-scientific-program/" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">annual meeting</a> of the National Academy of Medicine (NAM) here. He fleshed out more details on the agency's stated intentions to address the opioid epidemic.</div>
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The pharmaceutical industry is supporting limits to duration of use, the supply chain has imposed restrictions, and about 20 states have put limits on first-time opioid prescriptions, noted Dr Gottlieb.</div>
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"In an optimal world, we would see the provider community decide to work with these bodies," he said. But, he said, "We do see pushback from the provider community to a point about what this represents for intrusion and regulation of the practice of medicine."</div>
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Controlled substances are different ― and demand some intrusion, said Dr Gottlieb. "This is the one place where there has been a very long-standing, explicit expression from Congress that Congress intended that there be more regulation of the practice of medicine," he said.</div>
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<span style="box-sizing: border-box;">Limited-Dose Packaging</span></h3>
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The FDA's authority to more strictly regulate opioid prescribing is currently somewhat limited, but the agency is going to do what it can to reduce the total exposure to opioids, said Dr Gottlieb.</div>
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At the NAM meeting, he hit on a previously expressed sentiment that the nation "is simply awash in immediate-release [IR] opioid products," noting that IR formulations account for 90% of the 190 million opioid prescriptions written each year in the United States.</div>
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Reducing the number of prescriptions and the duration of those prescriptions means ensuring that the medications are for appropriate medical indications and that the duration of use "comports with the clinical circumstance," he said.</div>
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"We know that's not always happening," said Dr Gottlieb.</div>
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He said he would like to see IR formulations packaged in 3-, 6-, or 8-day packs, or that they be packaged in some other configuration of limited duration.</div>
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Such short-duration packs could be used for acute situations, such as for the treatment of postsurgical pain. For a longer duration of use ― such as for pain from metastatic cancer ― a prescriber "might have to go through mandatory education," he said.</div>
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Dr Gottlieb called on clinicians to help the FDA "build expert guidelines" that would spell out the appropriate duration of use for different clinical circumstances. Those guidelines could then be incorporated into drug labeling.</div>
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Massachusetts Governor Charlie Baker (R), a former CEO of Harvard Pilgrim Healthcare who is also on the President's Commission on Combatting Drug Addiction and the Opioid Crisis, said at the NAM meeting that clinicians in his state were responding well to limits on initial prescriptions and to a beefed-up prescription drug monitoring program (PDMP).</div>
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About 97% of prescribers use the PDMP, up from about half before a new state law went into effect. In addition, he said, in 2017, "for the first time in 15 years, the number of prescriptions and the number of deaths went down." Opioid-related deaths and prescriptions declined by 5% this year compared to 2016.</div>
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But, he noted, fentanyl is rapidly overtaking other opioids as a cause of overdose death, rising from 18% of such deaths in 2014 to 81% this year. "That is one brutal new wrinkle to this whole conversation," said Baker.</div>
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Dr Gottlieb said that if the FDA and other regulators had accurately seen what was coming a decade ago, they likely would have moved more incrementally to stem the rising tide. But given the size of the opioid problem now, "the type of action we need to take to get ahead of this crisis is going to be far more dramatic," he said.</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-19947500020422389712017-10-19T12:23:00.000-07:002017-10-19T12:23:08.035-07:00Burnout May Be Costing Your Institution Millions Each Year<div dir="ltr" style="text-align: left;" trbidi="on">
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SAN FRANCISCO — Burned out physicians are more likely to leave their job, and replacing them could be costing your institution millions of dollars each year, researchers reported October 13 at the 2017 American Conference on Physician Health.</div>
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Burnout is widespread among physicians in the United States, with numerous surveys showing rates above 50%. However, the effect of burnout on physician turnover in hospitals and academic medical centers is less well understood.</div>
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To learn more about its effects, Maryam S. Hamidi, PhD, associate director of scholarship and health promotion at Stanford Medicine WellMD Center in Palo Alto, California, and colleagues conducted a longitudinal study of physicians at Stanford Health Care and Stanford Children's Health.</div>
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Of 831 physicians invited, 473 completed the Stanford Physician Wellness Survey in 2013 and consented to have their unique identifier numbers included for data linkage. The survey included questions on burnout, work hours, and surgical specialty, and assessed depression, anxiety, and sleep issues through the PROMIS assessment tools. As <a href="https://wellmd.stanford.edu/content/dam/sm/wellmd/documents/med-staff-survey-report-4-2014.pdf" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">reported previously</a>, 25.8% of respondents were burned out.</div>
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Using the unique identifier numbers, Dr Hamidi and colleagues determined that 21% of burned out physicians had left Stanford by 2015 compared with just 10% of their non-burned-out peers. The authors estimate that the 11% difference between the groups was the proportion who departed because of burnout.</div>
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After adjusting for other factors, such as depression or work hours, they found that the odds of leaving the institution were 2.68-fold higher among burned out vs non-burned-out physicians. In addition, burnout was the only factor significantly related to departure in various models, Dr Hamidi said.</div>
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Recruitment Costs Run High</h3>
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When the researchers extrapolated the 11% departure rate caused by burnout to all 2023 medical faculty at Stanford Medicine, they estimate the institution would lose 58 physicians in a 2-year period.</div>
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The cost to recruit a new physician to Stanford runs between $268,000 and $957,000, according to data from the university's chief financial officer (CFO). Thus, replacing burned out physicians costs the institution between $15,544,000 and $55,506,000 in a 2-year period, Dr Hamidi told a standing-room-only audience.</div>
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After Dr Hamidi's presentation, several audience members asked what was included in the recruitment figure. Dr Hamidi and coauthor Bryan Bohman, interim director of Stanford Medicine WellMD Center, chief medical officer at University Healthcare Alliance, and clinical associate professor of anesthesia and critical care at the Stanford School of Medicine, emphasized that the estimated costs do not include any salary. Dr Bohman did note that some of the cost may be unique to Stanford because of the high cost of living, and that new-hire packages include housing support. But even if the number were cut in half, it is still a large cost, they note.</div>
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"I hear that number of $250,000 thrown around, but how do we get to that number?" one audience member asked. He noted that taking such a "dramatic number" to his CFO could be challenging.</div>
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"We actually got that data from our CFO," Dr Hamidi responded. "They have that data. That is a known number. They just hadn't linked it to burnout, which is what we've done here."</div>
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Chris Sinsky, MD, vice president of professional satisfaction at the American Medical Association and an internist at Medical Associates Clinic and Health Plans in Dubuque, Iowa, concurred with their findings. "Several pieces of data are completely aligned with what you have just presented," said Dr Sinksy, who was not involved in the study. "For example, some of the [healthcare chief executive officers] in the country have identified $500 to more than $1 million as the cost for recruitment for a physician. Also, the recruitment company Cejka has published their estimates, and they estimate it at $500 to $1.3 million, depending on whether there is a 6- or 12-month vacancy."</div>
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She also said that she and several colleagues recently <a href="https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2653912" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">published</a> a calculator in <i style="box-sizing: border-box;">JAMA Internal Medicine</i> that allows anyone interested to estimate the how much their institution spends to replace burned out physicians. "And it is very similar data to what you have here," she remarked.</div>
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Dr Bohman also noted that senior leadership at Stanford Medicine became much more interested in dealing with the issue of burnout after seeing these data. "After we engaged our CFO from the school of medicine in this study, the receptivity and interest in forming our WellMD Center and recruiting Tait [Shanafelt, MD, to lead it], had a significant inflection point."</div>
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"Aside from the other reasons that we need to take care of physicians and reduce burnout, aside from the humanistic reasons, we are trying to make a point that institutions should invest in preventing burnout because if they don't do that, it will have a high financial cost," Dr Hamidi said.</div>
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<i style="box-sizing: border-box;">The authors have disclosed no relevant financial relationships.</i></div>
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2017 American Conference on Physician Health. Presented October 13, 2017.</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-46500992396168926572017-10-19T12:22:00.000-07:002017-10-19T12:22:01.335-07:00Cardiac Motion: The Next Log-In Biometric?<div dir="ltr" style="text-align: left;" trbidi="on">
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BUFFALO, NY — The latest in state-of-the-art innovations using distinct biometric measures for security identification goes straight to the heart—literally.</div>
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The Cardiac Scan, described as a "noncontact and continuous heart-based user authentication system," utilizes low-level Doppler radar to identify not just each individual's unique heart dimensions but its function and motion as the security code allowing entry to a system such as a laptop and then continues to monitor the heart to make sure the security hasn't been breached by an unauthorized user<sup style="box-sizing: border-box; font-size: 0.85em; line-height: 1;">[<a href="https://www.blogger.com/null" style="box-sizing: border-box; color: #5757a6;">1</a>]</sup>.</div>
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"Cardiac motion is an automatic heart deformation caused by self-excitement of the cardiac muscle, which is unique to each user and is difficult, if not impossible, to counterfeit," explained the authors of a pilot study on the system, to be presented this month at <a href="https://sigmobile.org/mobicom/2017/" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">MobiCom 2017</a>, the Annual International Conference on Mobile Computing and Networking, a conference sponsored by the Association for Computing Machinery.</div>
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Heart-based biometrics systems have emerged in the past decade or so in measuring ECG signals, but those systems primarily use electrodes, whereas the Cardiac Scan is a noncontact, remote technology used to assess individual's distinctive heart biometrics.</div>
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The system requires approximately 8 seconds to s</div>
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can the heart on first use, and, after capturing the dimensions, can continuously monitor usage.</div>
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In a pilot study, the developers, with the University of Buffalo's School of Engineering and Applied Sciences, in New York, evaluated the system, including its accuracy, authentication time, usability in complex conditions, and vulnerability.</div>
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They found that over four cardiac cycles, the Cardiac Scan achieved a 98.6% rate of balanced accuracy and a 4.42% equal error rate.</div>
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"The accuracy is not as high as a professional fingerprint solution, for instance, 10 finger prints in the border check; it is close to daily-life biometric system, such as face recognition," lead author Dr Wenyao Xu, an assistant professor in the department of computer science and engineering, told <em style="box-sizing: border-box;">theheart.org | Medscape Cardiology</em>. Xu and his team have filed a patent on the Cardiac Scan technology.</div>
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Some key advantages the Cardiac Scan could have over other biometric tools, such as fingerprints or retinal scans, include that users are automatically authenticated without requiring any contact with the device; users are continuously monitored and do not have to log in or log off when away from their computers.</div>
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The system could also be integrated with other existing one-pass user identification techniques to allow for continuous authentication during use.</div>
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Xu noted that the system is able to detect a heart's distinctive features and motion regardless of how fast it is beating.</div>
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"The heart scan detects the distinctive motion feature oriented by the heart's shape, structure, and function, [and] beat frequency won't change these features," he explained.</div>
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It's analogous to facial recognition, where, no matter whether the subject is sitting or walking or running, their face won't change, he said. "We try to find the 'face' in the heart."</div>
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The system also can remarkably identify heart features even in a crowd, suggesting the potential to identify people of interest in a setting such as an airport security line.</div>
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"The radar can detect heart features without line of sight," Dr Xu said. "It can detect and recognize people with any angles."</div>
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Exposure to the signal of the Doppler radar poses no health risks and is an even lower signal strength than a Wi-Fi signal. "The reader is about 5 mW, even less than 1% of the radiation from our smartphones," Dr Xu said.</div>
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The researchers plan to miniaturize the scanning system to allow for installation on the corners of computer keyboards.</div>
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One potentially important limitation of the system is the role of cardiovascular disease and how that might compromise the ability to authenticate a match, the researchers say. So far, in the pilot stage, the system has been tested using only healthy people, the authors noted.</div>
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But just as a heart condition may result in an "access denied" response, it could also feasibly serve as an early warning of potential heart disease, Xu speculated.</div>
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"It is an interesting topic to explore," he said. "If someone cannot log in with a heart scan, he may want to see doctor and examine his heart health."</div>
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<span style="box-sizing: border-box;">Security Device, Diagnostic Tool?</span></h3>
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In commenting on the technology, Dr John A Osborne (Dallas Cardiovascular Center, TX) agreed that the technology is intriguing in its use of the multiple measures of the heart as a unique identifier.</div>
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"I think it's very intriguing," he told <em style="box-sizing: border-box;">theheart.org | Medscape Cardiology</em>. "What's interesting is even something simple like an ECG can be like a fingerprint because it's unique for each person, but of course in that case, you have to be hooked up to wires.</div>
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"But this is interesting because it goes to the next step of looking at size and geometry and change in the motion of the heart."</div>
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He added that the one potential key limitation of heart disease may compromise the system's function as a security device—but could meanwhile provide value as a diagnostic tool.</div>
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"The numerous things that could happen to your heart mechanically or electrically could certainly be exploited diagnostically, so a limitation of security could be where the diagnostic usefulness comes in."</div>
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<em style="box-sizing: border-box;">The research was supported in part by the US National Science Foundation. Xu and his team have filed a patent on the Cardiac Scan technology. Osborne had no relevant financial relationships.</em></div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-7055300830539622362017-10-19T12:18:00.003-07:002017-10-19T12:18:43.388-07:00AMA Launches Common Data Model Initiative<div dir="ltr" style="text-align: left;" trbidi="on">
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The American Medical Association (AMA) has <a href="https://www.ama-assn.org/ama-unleash-new-era-patient-care" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">launched</a> a collaborative of healthcare industry stakeholders to create a "common data model." Called the Integrated Health Model Initiative (IHMI), the program is intended to make it easier to pull together a wide variety of patient data in a structured format and exchange it among electronic health records (EHRs) from different companies.</div>
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Participation in IHMI is open to all healthcare and technology stakeholders. Early collaborators include IBM, Cerner, Intermountain Healthcare, the American Heart Association, and the American Medical Informatics Association, among others. The participants will interact in an online platform hosted by the AMA.</div>
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"We spend more than three trillion dollars a year on health care in America and generate more health data than ever before. Yet some of the most meaningful data — data to unlock potential improvements in patient outcomes — is fragmented, inaccessible or incomplete," said AMA CEO James L. Madara, MD, in a statement. "The collaborative effort of IHMI will help the health system learn how to collect, organize, and exchange patient-centered data in a common structure that captures what is most important for improving care and long-term wellness, and transform the data into a rich stream of accessible and actionable information."</div>
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Initially, IHMI will focus on three areas:</div>
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Hosting clinical and issue-based communities that address costly and burdensome areas. The initial priority of these communities will be the development of data elements for chronic conditions such as hypertension, diabetes, and asthma.</div>
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Creating a clinical validation process to determine and apply appropriate clinical frameworks. Participants will provide contributions and feedback online to specify data elements and relationships. Clinical content submissions will go through a validation process to review their clinical applicability.</div>
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Specifying a model to encode information in the IHMI data model. The clinical content will enable configurations of the model and reference value sets that will be made available for free.</div>
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<span style="box-sizing: border-box;">"Best Minds in Healthcare"</span></h3>
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Laurie McGraw, senior vice president of health solutions for the AMA and the lead on the IHMI project, told <em style="box-sizing: border-box;">Medscape Medical News</em> that the AMA wants to organize healthcare data better, turn more of it into usable information, and expand beyond the current boundaries of coded clinical data such as diagnostic and procedure codes. The goal, she said, is to include patient-reported information such as mobile device data and functional status data, plus data on social determinants of health.</div>
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The common data model will also establish standard terms for medical concepts that can be described in many different ways, McGraw said. She added that the AMA is working closely with SNOMED, the organization that maintains SNOMED-CT, the most complete lexicon of medical terms.</div>
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The importance of this component was underlined by David McCallie, MD, senior vice president for medical informatics at Cerner, who said in a statement that IHMI is designed "to improve the semantics of clinical data models. This represents a bold attempt to advance an important aspect of interoperability."</div>
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Stan Huff, MD, chief medical informatics officer of Intermountain Healthcare, said in a statement, "I am excited about IHMI because it builds on the foundation of interoperability standards that are being created by HL7, LOINC, and SNOMED International. If we persist, that approach will lead to the ability to exchange medical knowledge as executable software rather than as journal articles."</div>
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The AMA expects EHR vendors to incorporate IHMI into their software at some point, McGraw said. So far, only Cerner and Care Cloud, a small EHR vendor, have joined the project. But she said she is confident many other software developers will come aboard.</div>
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McGraw acknowledged that a lot of resources will be required to validate clinical data elements, encode the data as specified by the data model, and so forth. But she noted that the AMA has a team of in-house informaticists and that it will also rely on help from other IHMI participants.</div>
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Regarding clinical validation, she pointed out, the AMA produces Current Procedural Terminology codes, which must be constantly updated for new medical knowledge. "A volunteer army of the best minds in healthcare" works together to make sure this is done right, she said.</div>
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The AMA has been trying to get physicians more involved in the development of health information technology (IT) applications for some time. In January 2016, for example, the association invested $15 million in <a href="https://www.medscape.com/viewarticle/857071" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">Health2047</a>, a San Francisco-based "innovation enterprise" that develops new applications and work with established companies to fine-tune their health IT products. Later that year, the AMA adopted principles to promote the use of "safe and effective" mobile health apps and related devices.</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-67315115727281994152017-10-19T12:17:00.001-07:002017-10-19T12:17:06.948-07:00Should Physicians Treat Gun Violence as a Public Health Threat?<div dir="ltr" style="text-align: left;" trbidi="on">
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The recent mass shooting in Las Vegas was the largest in modern US history, with 58 people dead and more than 500 injured. This horrific event has once again highlighted gun violence and ignited a debate about whether physicians should wade into the national discussion on gun control.</div>
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On the one hand, a group of editors, publishing in the <em style="box-sizing: border-box;">Annals of Internal Medicine</em>, <em style="box-sizing: border-box;">JAMA</em>, the <em style="box-sizing: border-box;">New England Journal of Medicine</em>, and <em style="box-sizing: border-box;">PLOS Medicine</em>, <a href="https://www.medscape.com/viewarticle/886827" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">shared a list of ways</a> in which healthcare professionals can use their skills and voices to address gun violence as a public health threat. </div>
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On the other hand, a suggestion in a <a href="https://www.medscape.com/viewarticle/850352" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">recent Medscape essay</a> suggesting that physicians should not own guns drew more than 300 hostile comments from Medscape readers, many of them angrily stressing that gun ownership is a Second Amendment right.</div>
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Question 1 of 5</h2>
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Do you believe gun violence is a public health threat?</div>
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Yes</div>
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No</div>
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Unsure</div>
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Question 2 of 5</h2>
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Have you ever discussed gun safety with your patients?</div>
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</legend><label for="answer-1149140-2" style="align-items: center; background-color: white; border: 1px solid transparent; box-shadow: rgba(0, 0, 0, 0.15) 0px 1px 1px 0px; box-sizing: border-box; cursor: pointer; display: flex; height: auto; margin-bottom: 0.2em; overflow: hidden; position: relative; width: 650px;"><input data-question-id="364925" id="answer-1149140-2" name="2" style="height: 0px; opacity: 0; position: absolute; visibility: hidden; width: 0px;" type="radio" value="1149140" /><div class="answer-content" style="box-sizing: border-box; color: white; display: flex; width: 648px; z-index: 100;">
<ans style="align-items: center; border-radius: 50%; border: 1px solid rgba(0, 0, 0, 0.7); box-sizing: border-box; display: flex; height: 18px; justify-content: center; margin: 15px 10px 0px; padding: 1px; position: relative; transition: opacity 800ms ease; width: 18px;"><span style="background: rgb(0, 0, 0); border-radius: 50%; box-sizing: border-box; float: right; height: 6px; opacity: 0; transition: opacity 800ms ease; width: 6px;"></span></ans><div style="box-sizing: border-box; color: #2a2a2a; font-family: proxima_nova_ltlight, sans-serif; font-size: 1.25rem; line-height: 1.625rem; padding: 10px 40px 10px 0px; width: 583.188px;">
Yes, but only when the patient brought up the topic</div>
</div>
</label><label for="answer-1149142-2" style="align-items: center; background-color: white; border: 1px solid transparent; box-shadow: rgba(0, 0, 0, 0.15) 0px 1px 1px 0px; box-sizing: border-box; cursor: pointer; display: flex; height: auto; margin-bottom: 0.2em; overflow: hidden; position: relative; width: 650px;"><input data-question-id="364925" id="answer-1149142-2" name="2" style="height: 0px; opacity: 0; position: absolute; visibility: hidden; width: 0px;" type="radio" value="1149142" /><div class="answer-content" style="box-sizing: border-box; color: white; display: flex; width: 648px; z-index: 100;">
<ans style="align-items: center; border-radius: 50%; border: 1px solid rgba(0, 0, 0, 0.7); box-sizing: border-box; display: flex; height: 18px; justify-content: center; margin: 15px 10px 0px; padding: 1px; position: relative; transition: opacity 800ms ease; width: 18px;"><span style="background: rgb(0, 0, 0); border-radius: 50%; box-sizing: border-box; float: right; height: 6px; opacity: 0; transition: opacity 800ms ease; width: 6px;"></span></ans><div style="box-sizing: border-box; color: #2a2a2a; font-family: proxima_nova_ltlight, sans-serif; font-size: 1.25rem; line-height: 1.625rem; padding: 10px 40px 10px 0px; width: 583.188px;">
Yes, when I brought up the topic with the patient</div>
</div>
</label><label for="answer-1149144-2" style="align-items: center; background-color: white; border: 1px solid transparent; box-shadow: rgba(0, 0, 0, 0.15) 0px 1px 1px 0px; box-sizing: border-box; cursor: pointer; display: flex; height: auto; margin-bottom: 0.2em; overflow: hidden; position: relative; width: 650px;"><input data-question-id="364925" id="answer-1149144-2" name="2" style="height: 0px; opacity: 0; position: absolute; visibility: hidden; width: 0px;" type="radio" value="1149144" /><div class="answer-content" style="box-sizing: border-box; color: white; display: flex; width: 648px; z-index: 100;">
<ans style="align-items: center; border-radius: 50%; border: 1px solid rgba(0, 0, 0, 0.7); box-sizing: border-box; display: flex; height: 18px; justify-content: center; margin: 15px 10px 0px; padding: 1px; position: relative; transition: opacity 800ms ease; width: 18px;"><span style="background: rgb(0, 0, 0); border-radius: 50%; box-sizing: border-box; float: right; height: 6px; opacity: 0; transition: opacity 800ms ease; width: 6px;"></span></ans><div style="box-sizing: border-box; color: #2a2a2a; font-family: proxima_nova_ltlight, sans-serif; font-size: 1.25rem; line-height: 1.625rem; padding: 10px 40px 10px 0px; width: 583.188px;">
Yes, both when the patient brought up the topic and when I brought up the topic</div>
</div>
</label><label for="answer-1149146-2" style="align-items: center; background-color: white; border: 1px solid transparent; box-shadow: rgba(0, 0, 0, 0.15) 0px 1px 1px 0px; box-sizing: border-box; cursor: pointer; display: flex; height: auto; margin-bottom: 0.2em; overflow: hidden; position: relative; width: 650px;"><input data-question-id="364925" id="answer-1149146-2" name="2" style="height: 0px; opacity: 0; position: absolute; visibility: hidden; width: 0px;" type="radio" value="1149146" /><div class="answer-content" style="box-sizing: border-box; color: white; display: flex; width: 648px; z-index: 100;">
<ans style="align-items: center; border-radius: 50%; border: 1px solid rgba(0, 0, 0, 0.7); box-sizing: border-box; display: flex; height: 18px; justify-content: center; margin: 15px 10px 0px; padding: 1px; position: relative; transition: opacity 800ms ease; width: 18px;"><span style="background: rgb(0, 0, 0); border-radius: 50%; box-sizing: border-box; float: right; height: 6px; opacity: 0; transition: opacity 800ms ease; width: 6px;"></span></ans><div style="box-sizing: border-box; color: #2a2a2a; font-family: proxima_nova_ltlight, sans-serif; font-size: 1.25rem; line-height: 1.625rem; padding: 10px 40px 10px 0px; width: 583.188px;">
No, I have never discussed gun safety with a patient</div>
</div>
</label></div>
</fieldset>
<h2 style="border-bottom: 2px solid rgb(56, 148, 162); box-sizing: border-box; color: #2f2148; font-family: proxima_nova_ltlight, sans-serif; font-size: 1.5rem; font-weight: normal; line-height: 1.17; margin: 0px 0px 16px; padding: 0px 0px 3px;">
Question 3 of 5</h2>
<fieldset style="border-color: initial; border-style: none; border-width: initial; box-sizing: border-box; margin: 0px; padding: 0px 0px 2rem;">
<div class="qna-question" data-question-id="364927" id="qna-question-364927" style="box-sizing: border-box;">
<legend style="box-sizing: border-box; max-width: 100%; width: 650px;"><div class="question-content" style="box-sizing: border-box;">
<div style="box-sizing: border-box; padding: 0px 0px 10px;">
Do you think physicians have a responsibility to discuss gun safety with their patients?</div>
</div>
</legend><label for="answer-1149148-3" style="align-items: center; background-color: white; border: 1px solid transparent; box-shadow: rgba(0, 0, 0, 0.15) 0px 1px 1px 0px; box-sizing: border-box; cursor: pointer; display: flex; height: auto; margin-bottom: 0.2em; overflow: hidden; position: relative; width: 650px;"><input data-question-id="364927" id="answer-1149148-3" name="3" style="height: 0px; opacity: 0; position: absolute; visibility: hidden; width: 0px;" type="radio" value="1149148" /><div class="answer-content" style="box-sizing: border-box; color: white; display: flex; width: 648px; z-index: 100;">
<ans style="align-items: center; border-radius: 50%; border: 1px solid rgba(0, 0, 0, 0.7); box-sizing: border-box; display: flex; height: 18px; justify-content: center; margin: 15px 10px 0px; padding: 1px; position: relative; transition: opacity 800ms ease; width: 18px;"><span style="background: rgb(0, 0, 0); border-radius: 50%; box-sizing: border-box; float: right; height: 6px; opacity: 0; transition: opacity 800ms ease; width: 6px;"></span></ans><div style="box-sizing: border-box; color: #2a2a2a; font-family: proxima_nova_ltlight, sans-serif; font-size: 1.25rem; line-height: 1.625rem; padding: 10px 40px 10px 0px; width: 583.188px;">
Yes</div>
</div>
</label><label for="answer-1149150-3" style="align-items: center; background-color: white; border: 1px solid transparent; box-shadow: rgba(0, 0, 0, 0.15) 0px 1px 1px 0px; box-sizing: border-box; cursor: pointer; display: flex; height: auto; margin-bottom: 0.2em; overflow: hidden; position: relative; width: 650px;"><input data-question-id="364927" id="answer-1149150-3" name="3" style="height: 0px; opacity: 0; position: absolute; visibility: hidden; width: 0px;" type="radio" value="1149150" /><div class="answer-content" style="box-sizing: border-box; color: white; display: flex; width: 648px; z-index: 100;">
<ans style="align-items: center; border-radius: 50%; border: 1px solid rgba(0, 0, 0, 0.7); box-sizing: border-box; display: flex; height: 18px; justify-content: center; margin: 15px 10px 0px; padding: 1px; position: relative; transition: opacity 800ms ease; width: 18px;"><span style="background: rgb(0, 0, 0); border-radius: 50%; box-sizing: border-box; float: right; height: 6px; opacity: 0; transition: opacity 800ms ease; width: 6px;"></span></ans><div style="box-sizing: border-box; color: #2a2a2a; font-family: proxima_nova_ltlight, sans-serif; font-size: 1.25rem; line-height: 1.625rem; padding: 10px 40px 10px 0px; width: 583.188px;">
No</div>
</div>
</label><label for="answer-1149152-3" style="align-items: center; background-color: white; border: 1px solid transparent; box-shadow: rgba(0, 0, 0, 0.15) 0px 1px 1px 0px; box-sizing: border-box; cursor: pointer; display: flex; height: auto; margin-bottom: 0.2em; overflow: hidden; position: relative; width: 650px;"><input data-question-id="364927" id="answer-1149152-3" name="3" style="height: 0px; opacity: 0; position: absolute; visibility: hidden; width: 0px;" type="radio" value="1149152" /><div class="answer-content" style="box-sizing: border-box; color: white; display: flex; width: 648px; z-index: 100;">
<ans style="align-items: center; border-radius: 50%; border: 1px solid rgba(0, 0, 0, 0.7); box-sizing: border-box; display: flex; height: 18px; justify-content: center; margin: 15px 10px 0px; padding: 1px; position: relative; transition: opacity 800ms ease; width: 18px;"><span style="background: rgb(0, 0, 0); border-radius: 50%; box-sizing: border-box; float: right; height: 6px; opacity: 0; transition: opacity 800ms ease; width: 6px;"></span></ans><div style="box-sizing: border-box; color: #2a2a2a; font-family: proxima_nova_ltlight, sans-serif; font-size: 1.25rem; line-height: 1.625rem; padding: 10px 40px 10px 0px; width: 583.188px;">
Unsure</div>
</div>
</label></div>
</fieldset>
<h2 style="border-bottom: 2px solid rgb(56, 148, 162); box-sizing: border-box; color: #2f2148; font-family: proxima_nova_ltlight, sans-serif; font-size: 1.5rem; font-weight: normal; line-height: 1.17; margin: 0px 0px 16px; padding: 0px 0px 3px;">
Question 4 of 5</h2>
<fieldset style="border-color: initial; border-style: none; border-width: initial; box-sizing: border-box; margin: 0px; padding: 0px 0px 2rem;">
<div class="qna-question" data-question-id="364929" id="qna-question-364929" style="box-sizing: border-box;">
<legend style="box-sizing: border-box; max-width: 100%; width: 650px;"><div class="question-content" style="box-sizing: border-box;">
<div style="box-sizing: border-box; padding: 0px 0px 10px;">
How prepared are you to discuss gun safety with patients?</div>
</div>
</legend><label for="answer-1149154-4" style="align-items: center; background-color: white; border: 1px solid transparent; box-shadow: rgba(0, 0, 0, 0.15) 0px 1px 1px 0px; box-sizing: border-box; cursor: pointer; display: flex; height: auto; margin-bottom: 0.2em; overflow: hidden; position: relative; width: 650px;"><input data-question-id="364929" id="answer-1149154-4" name="4" style="height: 0px; opacity: 0; position: absolute; visibility: hidden; width: 0px;" type="radio" value="1149154" /><div class="answer-content" style="box-sizing: border-box; color: white; display: flex; width: 648px; z-index: 100;">
<ans style="align-items: center; border-radius: 50%; border: 1px solid rgba(0, 0, 0, 0.7); box-sizing: border-box; display: flex; height: 18px; justify-content: center; margin: 15px 10px 0px; padding: 1px; position: relative; transition: opacity 800ms ease; width: 18px;"><span style="background: rgb(0, 0, 0); border-radius: 50%; box-sizing: border-box; float: right; height: 6px; opacity: 0; transition: opacity 800ms ease; width: 6px;"></span></ans><div style="box-sizing: border-box; color: #2a2a2a; font-family: proxima_nova_ltlight, sans-serif; font-size: 1.25rem; line-height: 1.625rem; padding: 10px 40px 10px 0px; width: 583.188px;">
Very prepared</div>
</div>
</label><label for="answer-1149156-4" style="align-items: center; background-color: white; border: 1px solid transparent; box-shadow: rgba(0, 0, 0, 0.15) 0px 1px 1px 0px; box-sizing: border-box; cursor: pointer; display: flex; height: auto; margin-bottom: 0.2em; overflow: hidden; position: relative; width: 650px;"><input data-question-id="364929" id="answer-1149156-4" name="4" style="height: 0px; opacity: 0; position: absolute; visibility: hidden; width: 0px;" type="radio" value="1149156" /><div class="answer-content" style="box-sizing: border-box; color: white; display: flex; width: 648px; z-index: 100;">
<ans style="align-items: center; border-radius: 50%; border: 1px solid rgba(0, 0, 0, 0.7); box-sizing: border-box; display: flex; height: 18px; justify-content: center; margin: 15px 10px 0px; padding: 1px; position: relative; transition: opacity 800ms ease; width: 18px;"><span style="background: rgb(0, 0, 0); border-radius: 50%; box-sizing: border-box; float: right; height: 6px; opacity: 0; transition: opacity 800ms ease; width: 6px;"></span></ans><div style="box-sizing: border-box; color: #2a2a2a; font-family: proxima_nova_ltlight, sans-serif; font-size: 1.25rem; line-height: 1.625rem; padding: 10px 40px 10px 0px; width: 583.188px;">
Somewhat prepared</div>
</div>
</label><label for="answer-1149158-4" style="align-items: center; background-color: white; border: 1px solid transparent; box-shadow: rgba(0, 0, 0, 0.15) 0px 1px 1px 0px; box-sizing: border-box; cursor: pointer; display: flex; height: auto; margin-bottom: 0.2em; overflow: hidden; position: relative; width: 650px;"><input data-question-id="364929" id="answer-1149158-4" name="4" style="height: 0px; opacity: 0; position: absolute; visibility: hidden; width: 0px;" type="radio" value="1149158" /><div class="answer-content" style="box-sizing: border-box; color: white; display: flex; width: 648px; z-index: 100;">
<ans style="align-items: center; border-radius: 50%; border: 1px solid rgba(0, 0, 0, 0.7); box-sizing: border-box; display: flex; height: 18px; justify-content: center; margin: 15px 10px 0px; padding: 1px; position: relative; transition: opacity 800ms ease; width: 18px;"><span style="background: rgb(0, 0, 0); border-radius: 50%; box-sizing: border-box; float: right; height: 6px; opacity: 0; transition: opacity 800ms ease; width: 6px;"></span></ans><div style="box-sizing: border-box; color: #2a2a2a; font-family: proxima_nova_ltlight, sans-serif; font-size: 1.25rem; line-height: 1.625rem; padding: 10px 40px 10px 0px; width: 583.188px;">
Not at all prepared</div>
</div>
</label></div>
</fieldset>
<h2 style="border-bottom: 2px solid rgb(56, 148, 162); box-sizing: border-box; color: #2f2148; font-family: proxima_nova_ltlight, sans-serif; font-size: 1.5rem; font-weight: normal; line-height: 1.17; margin: 0px 0px 16px; padding: 0px 0px 3px;">
Question 5 of 5</h2>
<fieldset style="border-color: initial; border-style: none; border-width: initial; box-sizing: border-box; margin: 0px; padding: 0px 0px 2rem;">
<div class="qna-question" data-question-id="364931" id="qna-question-364931" style="box-sizing: border-box;">
<legend style="box-sizing: border-box; max-width: 100%; width: 650px;"><div class="question-content" style="box-sizing: border-box;">
<div style="box-sizing: border-box; padding: 0px 0px 10px;">
Do you own any guns?</div>
</div>
</legend><label for="answer-1149160-5" style="align-items: center; background-color: white; border: 1px solid transparent; box-shadow: rgba(0, 0, 0, 0.15) 0px 1px 1px 0px; box-sizing: border-box; cursor: pointer; display: flex; height: auto; margin-bottom: 0.2em; overflow: hidden; position: relative; width: 650px;"><input data-question-id="364931" id="answer-1149160-5" name="5" style="height: 0px; opacity: 0; position: absolute; visibility: hidden; width: 0px;" type="radio" value="1149160" /><div class="answer-content" style="box-sizing: border-box; color: white; display: flex; width: 648px; z-index: 100;">
<ans style="align-items: center; border-radius: 50%; border: 1px solid rgba(0, 0, 0, 0.7); box-sizing: border-box; display: flex; height: 18px; justify-content: center; margin: 15px 10px 0px; padding: 1px; position: relative; transition: opacity 800ms ease; width: 18px;"><span style="background: rgb(0, 0, 0); border-radius: 50%; box-sizing: border-box; float: right; height: 6px; opacity: 0; transition: opacity 800ms ease; width: 6px;"></span></ans><div style="box-sizing: border-box; color: #2a2a2a; font-family: proxima_nova_ltlight, sans-serif; font-size: 1.25rem; line-height: 1.625rem; padding: 10px 40px 10px 0px; width: 583.188px;">
Yes</div>
</div>
</label><label for="answer-1149162-5" style="align-items: center; background-color: white; border: 1px solid transparent; box-shadow: rgba(0, 0, 0, 0.15) 0px 1px 1px 0px; box-sizing: border-box; cursor: pointer; display: flex; height: auto; margin-bottom: 0.2em; overflow: hidden; position: relative; width: 650px;"><input data-question-id="364931" id="answer-1149162-5" name="5" style="height: 0px; opacity: 0; position: absolute; visibility: hidden; width: 0px;" type="radio" value="1149162" /><div class="answer-content" style="box-sizing: border-box; color: white; display: flex; width: 648px; z-index: 100;">
<ans style="align-items: center; border-radius: 50%; border: 1px solid rgba(0, 0, 0, 0.7); box-sizing: border-box; display: flex; height: 18px; justify-content: center; margin: 15px 10px 0px; padding: 1px; position: relative; transition: opacity 800ms ease; width: 18px;"><span style="background: rgb(0, 0, 0); border-radius: 50%; box-sizing: border-box; float: right; height: 6px; opacity: 0; transition: opacity 800ms ease; width: 6px;"></span></ans><div style="box-sizing: border-box; color: #2a2a2a; font-family: proxima_nova_ltlight, sans-serif; font-size: 1.25rem; line-height: 1.625rem; padding: 10px 40px 10px 0px; width: 583.188px;">
No</div>
</div>
</label><label for="answer-1149164-5" style="align-items: center; background-color: white; border: 1px solid transparent; box-shadow: rgba(0, 0, 0, 0.15) 0px 1px 1px 0px; box-sizing: border-box; cursor: pointer; display: flex; height: auto; margin-bottom: 0.2em; overflow: hidden; position: relative; width: 650px;"><input data-question-id="364931" id="answer-1149164-5" name="5" style="height: 0px; opacity: 0; position: absolute; visibility: hidden; width: 0px;" type="radio" value="1149164" /><div class="answer-content" style="box-sizing: border-box; color: white; display: flex; width: 648px; z-index: 100;">
<ans style="align-items: center; border-radius: 50%; border: 1px solid rgba(0, 0, 0, 0.7); box-sizing: border-box; display: flex; height: 18px; justify-content: center; margin: 15px 10px 0px; padding: 1px; position: relative; transition: opacity 800ms ease; width: 18px;"><span style="background: rgb(0, 0, 0); border-radius: 50%; box-sizing: border-box; float: right; height: 6px; opacity: 0; transition: opacity 800ms ease; width: 6px;"></span></ans><div style="box-sizing: border-box; color: #2a2a2a; font-family: proxima_nova_ltlight, sans-serif; font-size: 1.25rem; line-height: 1.625rem; padding: 10px 40px 10px 0px; width: 583.188px;">
Prefer not to answer</div>
</div>
</label></div>
</fieldset>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-8391779202070907462017-10-19T12:15:00.000-07:002017-10-19T12:15:12.549-07:00Uncontrolled Hypertension Unchanged in US Adults<div dir="ltr" style="text-align: left;" trbidi="on">
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HYATTSVILLE, MD — Only about 48% of adults with hypertension had it under control during 2015–2016, according to data released today by the National Center for Health Statistics (NCHS) at the Centers for Disease Control and Prevention (CDC)<sup style="box-sizing: border-box; font-size: 0.85em; line-height: 1;">[<a href="https://www.blogger.com/null" style="box-sizing: border-box; color: #5757a6;">1</a>]</sup>.</div>
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"This finding that just under half of adults with hypertension have their BP under control is consistent with estimates since 2010," first author Cheryl Fryar, NCHS Division of Health and Nutrition Examination Surveys, told <em style="box-sizing: border-box;">theheart.org | Medscape Cardiology</em>. "However, this statistic shows that we have yet to meet the Healthy People 2020 goal of 61.2% for hypertension control."</div>
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The report also shows that hypertension is more prevalent in US non-Hispanic black adults than in other race/ethnic-origin groups.</div>
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Hypertension raises the risk of cardiovascular disease and "remains an important public-health challenge" in the US. Effective control of elevated blood pressure has been shown to reduce stroke, MI, and heart failure, Fryar and her colleagues note.</div>
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Based on National Health and Nutrition Examination Survey (NHANES) data, in 2015–2016, the overall prevalence of hypertension among adults was 29.0%. It was similar in men (30.2%) and women (27.7%) and increased with age, from 7.5% in adults 18 to 39, to 33.2% in adults 40 to 59 years, to 63.1% in those aged 60 and older.</div>
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The prevalence of hypertension was higher in men than women in those aged 18 to 39 (9.2% vs 5.6%) and those 40 to 59 (37.2% vs 29.4%), but in the 60+ age group, men had a lower prevalence of hypertension than women (58.5% vs 66.8%).</div>
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There were also differences in hypertension prevalence by race and Hispanic origin during 2015–2016. For all adults, the prevalence of hypertension among non-Hispanic black adults was higher (40.3%) than among non-Hispanic white (27.8%), non-Hispanic Asian (25.0%), and Hispanic (27.8%) adults.</div>
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<span style="box-sizing: border-box; font-family: proxima_nova_rgbold, sans-serif;">Uncontrolled BP Common</span></div>
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Among adults with hypertension during 2015–2016, only 48.3% had controlled hypertension, the authors say.</div>
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The prevalence of controlled hypertension overall increased with age and was lower among those aged 18 to 39 years (32.5%) than among those aged 40 to 59 years (50.8%) and 60 and over (49.4%). A higher percentage of women had controlled hypertension than men, both overall (52.5% vs 45.7%) and among those aged 18 to 39 (62.6% vs 15.5%).</div>
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The prevalence of hypertension control among all adults with hypertension was higher among non-Hispanic whites (50.8%) than among non-Hispanic blacks (44.6%) and non-Hispanic Asians (37.4%).</div>
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Using NHANES data, the researchers also assessed trends in overall prevalence and control of hypertension between 1999 and 2016.</div>
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They found no significant change in the prevalence of hypertension among US adults during the 9-year study period. However, the prevalence of controlled hypertension among adults rose from 31.6% in 1999–2000 to 53.1% in 2009–2010, with no significant changes from 2009–2010 through the end of the study period.</div>
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There was a nonsignificant decrease in hypertension control between 2013–2014 and 2015–2016 (53.9% to 48.3%).</div>
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<b><u>REFERENCES:</u></b></div>
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<li><span style="color: #2a2a2a; font-family: proxima_nova_rgregular, sans-serif;"><span style="font-size: 20px;"><b><u>Fryar CD, OstchegaY, Hales CM, et al. National Center for Health Statistics Data Brief 289. Hypertension Prevalence and Control Among Adults: United States, 2015–2016. October 2017. <a href="https://www.cdc.gov/nchs/products/databriefs/db289.htm" style="background-color: white; box-sizing: border-box; color: #5757a6; font-family: proxima_nova_rgregular, arial, sans-serif; font-size: 16px; font-weight: normal; text-decoration-line: none;">Article</a></u></b></span></span></li>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-85063727434785338092017-10-19T12:11:00.001-07:002017-10-19T12:11:22.399-07:00Prior Head Injury Linked to Amyloid Deposition<div dir="ltr" style="text-align: left;" trbidi="on">
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SAN DIEGO — Patients with a history of head injury show significant increases in amyloid deposition in key parts of the brain, including the frontal cortex, a finding that further supports evidence linking head injury with dementia later in life.</div>
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"Our study found associations between prior head injury and increased amyloid deposition both globally and within the frontal cortex, including orbitofrontal, prefrontal, and superior frontal cortices," Andrea Schneider, MD, PhD, from Johns Hopkins University, Baltimore, Maryland, told<em style="box-sizing: border-box;"> Medscape Medical News.</em></div>
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"Our findings suggest that the frontal cortex may be particularly susceptible to the damaging effects of head injury."</div>
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The findings were presented here at the ANA 2017: 48th Annual Meeting of the American Neurological Association.</div>
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Head injury has been linked to dementia in previous epidemiologic studies, and while the mechanisms are not well understood, amyloid and tau depositions are speculated to be likely factors.</div>
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To take a closer look at the association, Dr Schneider and her colleagues identified 329 participants in the Atherosclerosis Risk and Communities (ARIC) study who underwent positron emission tomography assessing brain amyloid deposition between 2011 and 2013.</div>
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The patients had a mean age of 76 years, 57% were female, 43% were black, and 20% had a history of head injury, defined by self-report or hospitalization International Classification of Diseases, Ninth Revision, codes. Approximately one third (27%) of patients had mild cognitive impairment; however, patients with dementia were excluded.</div>
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Dr Schneider noted that patients with head injuries had sustained the injuries a mean of approximately 25 years earlier.</div>
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Those with a history of head injury showed elevated (greater than 1.2) standard uptake value ratios (SUVRs) indicating the presence of amyloid deposition, in global assessments (prevalence ratio [PR], 1.31; 95% confidence interval [CI], 1.07 - 1.60).</div>
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The elevated levels were specifically in the orbitofrontal cortex (PR, 1.24; 95% CI, 1.02 - 1.50), the prefrontal cortex (PR, 1.24; 95% CI, 1.03 - 1.49), and the superior frontal cortex (PR, 1.29; 95% CI, 1.06 - 1.56).</div>
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Meanwhile, there were no significant differences in the prevalence of elevated SUVR in the anterior cingulate, posterior cingulate, precuneus, lateral temporal, parietal, or occipital lobes (all <em style="box-sizing: border-box;">P</em> > .05).</div>
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"It was exciting to see that the frontal cortex was particularly associated with increased amyloid deposition among those with prior head injury," Dr Schneider said.</div>
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"We had also hypothesized that the posterior cingulate and precuneus areas would have elevated amyloid deposition, as these areas, along with the frontal cortex, have been shown to have early amyloid deposition in Alzheimer's dementia — but this hypothesis was not validated in our sample."</div>
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The findings add to ongoing speculation of a link between traumatic brain injury (TBI) and Alzheimer's disease, Dr Schneider added.</div>
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"Overall, our study is consistent with the conclusion that there is some overlap in areas with amyloid deposition in TBI and in early Alzheimer's pathology," she said.</div>
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Additional research is needed to better understand how amyloid deposition with head injury relates to dementia, Dr Schneider noted.</div>
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"Further work is needed to determine if this increased amyloid deposition contributes to dementia and cognitive decline following head injury in this population — this is an area of active research within the ARIC cohort study."</div>
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<span style="box-sizing: border-box;">Insight on Mechanism</span></h3>
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The study offers important insights on the possible mechanisms that could explain how TBI and amyloid relate, said Ramon Diaz-Arrastia, MD, PhD, presidential professor of neurology and attending neurologist at the Penn Presbyterian Medical Center Hospital of the University of Pennsylvania, in Philadelphia.<br style="box-sizing: border-box;" /><br style="box-sizing: border-box;" />"It's been known for a long time that TBI, particularly more moderate or severe injury, is associated with an increased risk of dementia — approximately two- or threefold or so," he told <em style="box-sizing: border-box;">Medscape Medical News</em>.</div>
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"But little is known about the mechanism, and there is some [speculation] that TBI accelerates Alzheimer's disease pathology, and another view is that it accelerates perhaps another type of pathology, such as tau-related pathology or vascular dementia," he explained.</div>
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"So I think this is an important study because it is among the few that have looked at amyloid deposition in people with a history with TBI."</div>
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The location of the amyloid disposition that was identified "is also intriguing in that it is different from that expected with Alzheimer's disease," Dr Diaz-Arrastia said.</div>
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"The increased amyloid deposition is not in the canonical Alzheimer's disease regions but rather in these areas in the frontal lobes, which is important because the indications are that the features of dementia in people with TBI are not exactly like those we see with Alzheimer's disease."</div>
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<em style="box-sizing: border-box;">The authors and Dr Diaz-Arrastia have disclosed no relevant financial relationships.</em></div>
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ANA 2017: 48th Annual Meeting of the American Neurological Association. Abstract M336WIP. Presented October 16, 2017.</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-21608199743839223862017-10-19T12:07:00.002-07:002017-10-19T12:07:16.687-07:00Transfusions From Ever-Pregnant Women May Up Mortality Risk<div dir="ltr" style="text-align: left;" trbidi="on">
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Transfusions from females who have been pregnant to males, especially those younger than 50 years, may be associated with increased risk for all-cause mortality, compared with such transfusions to females or with transfusions from women who have never been pregnant to recipients of either sex, according to a study <a href="https://jamanetwork.com/journals/jama/article-abstract/2657377" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">published online</a> on October 17 in <em style="box-sizing: border-box;">JAMA.</em></div>
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Since 2011, several studies have suggested that blood transfusions from women are riskier for recipients than are transfusions from men, and that that risk is greatest from women who have been pregnant. The most common cause of transfusion-related mortality, acute lung injury, is associated with use of plasma-rich products, suggesting an antibody-mediated immune response.</div>
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To further examine these associations, Camila Caram-Deelder, a PhD student in the Department of Transfusion Medicine at Sanquin Research, Leiden, the Netherlands, and coworkers analyzed the association between red blood cell transfusion from female blood donors, with and without a history of pregnancy, and mortality among male and female recipients. Sanquin is the source of blood in the Netherlands, and all blood is leukocyte-depleted.</div>
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The researchers used a retrospective cohort of people who received their first transfusion between May 30, 2005, and September 1, 2015, at one of six major Dutch hospitals. They considered the age and sex of recipients and the sex and pregnancy history (when known) of donors. Some data were recorded before questions were asked about pregnancy status.</div>
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The original database included information from 42,132 patients who received 106,641 units of red blood cells (76% from male donors, 12% from ever-pregnant donors, 12% from never-pregnant female donors). From this group, the researchers further assessed a "no-donor-mixture" cohort of 31,118 patients who received 59,320 units of red blood cells exclusively from male donors, exclusively from female donors without a history of pregnancy (never-pregnant donors), or exclusively from female donors with a history of pregnancy (ever-pregnant donors).</div>
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The investigation followed the recipients for a median of 245 days. The median age of the recipients was 65 years, and 16,123 (52%) were female. During follow-up, 3969 recipients died.</div>
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The hazard ratio (HR) for death after receiving one additional unit of red blood cells from a never-pregnant female donor, compared with receiving a unit from a male donor, was 0.93 (95% confidence interval [CI], 0.81 - 1.06) for male recipients and 1.01 (95% CI, 0.88 - 1.15) for female recipients. In contrast, the HR for death after one additional unit of red blood cells from an ever-pregnant female donor, compared with a unit from a male donor, was 1.13 (95% CI, 1.01 - 1.26) for male recipients and 0.99 (95% CI, 0.87 - 1.13) for female recipients.</div>
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The largest increase in mortality was found in male patients younger than 50 years who received transfusions from ever-pregnant donors (for ages 0 to 18 years: HR, 1.63; 95% CI, 1.02 - 2.61; for ages 18 to 50 years: HR, 1.50; 95% CI, 0.98 - 2.30).</div>
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Analysis of a subgroup who underwent single transfusions revealed 3-year cumulative mortality among male recipients of 13.5% after receiving a transfusion from a male donor and 13.1% after receiving a transfusion from a never-pregnant female donor (difference, 0.4%; 95% CI, −3.8% to 3.0%). The 3-year cumulative mortality among male recipients was 16.9% after receiving a transfusion from an ever-pregnant female donor (difference, 3.5%; 95% CI, −0.3% to 7.2%).</div>
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Among female recipients, mortality was 12.6% after a transfusion from a male donor and 12.0% after a transfusion from a never-pregnant female donor (difference, 0.6%; 95% CI, −3.7% to 2.6%) and 15.9% after a transfusion from an ever-pregnant female donor (difference, 3.3%; 95% CI, −0.5% to 7.1%).</div>
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For the full cohort (including individuals who had received blood from more than one of the three groups), HR of transfusion from an ever-pregnant female donor compared with a male donor was 1.08 (95% CI, 1.02 - 1.15) for all male recipients, 1.18 (95% CI, 0.82 - 1.69) for male recipients through age 17, and 1.43 (95% CI, 1.13 - 1.82) for male recipients aged 18 through 50. For female recipients, the HR for death after one additional unit of red blood cells from an ever-pregnant female donor compared to a male donor was 0.99 (95% CI, 0.93 - 1.07).</div>
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The researchers conclude, "Male recipients who received a transfusion from an ever-pregnant female donor had a statistically significant increase in mortality compared with those who received a transfusion from a male donor or from a female donor without a history of pregnancy. There was no significant association between pregnancy status of female donors of red blood cells and mortality among female recipients of red blood cell transfusions."</div>
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An alternative hypothesis to an immune response against male antigens is iron-deficiency anemia in blood from females, which would possibly mean greater need for additional transfusions for recipients, but would not explain the sex difference for mortality among recipients.</div>
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Limitations of the study include the lack of information on cause of death and the absence of pregnancy information for earlier blood donations.</div>
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In an <a href="https://jamanetwork.com/journals/jama/article-abstract/2657356" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">accompanying editorial</a>, Ritchard G. Cable, MD, of the American Red Cross Blood Services in Farmington, Connecticut, and Gustaf Edgren, MD, PhD, of the Department of Medical Epidemiology and Biostatistics at the Karolinska Institute, Stockholm, Sweden, point out the complexity of the data and possible sources of confusion.</div>
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Exclusion of patients who received transfusions from more than one of the three types of donors (male, ever-pregnant, and never-pregnant) could have excluded sicker patients who required more transfusions.</div>
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The fact that blood from females has about 8% less hemoglobin may have influenced the number of transfusions that individuals required.</div>
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Some of the older women in the overall cohort, who joined before pregnancy status was queried, may have been pregnant. Without this information, the study design could not capture waning effects of immunity with time.</div>
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The greater effect among men younger than 50 could reflect the effect of androgens, not restriction to males.</div>
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Dr Cable and Dr Edgren suggest that if the immune response to paternal (Y chromosome-encoded) antigens is the underlying mechanism, then blood from mothers of sons should present a greater risk than blood from mothers of daughters. However, this was not examined in the current study.</div>
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"In light of the limitations of the study by Caram-Deelder et al, current criteria for blood donor selection should not change. However, additional investigation is needed," Dr Cable and Dr Edgren write. They also advocate extending analysis to a more genetically diverse population than persons living in the Netherlands.</div>
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If the association between ever-pregnant female blood donors and increased male recipient mortality persists with expanded studies, then blood centers might institute sex-matched transfusions and improve methods of purifying red blood cell products, the editorial writers suggest.</div>
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<em style="box-sizing: border-box;">Dr Zwaginga has received a speaking fee from Vifor Pharma and serves on the advisory councils of Novartis and Amgen Science. The other authors and the editorialist have disclosed no relevant financial relationships.</em></div>
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<em style="box-sizing: border-box;">JAMA.</em> Published online October 17, 2017. <a href="https://jamanetwork.com/journals/jama/article-abstract/2657377" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">Abstract</a>, <a href="https://jamanetwork.com/journals/jama/article-abstract/2657356" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">Editorial</a></div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-21627040690539304702017-10-19T12:04:00.002-07:002017-10-19T12:04:36.515-07:00'Massive' Suffering: Pain Relief in Less Affluent Countries<div dir="ltr" style="text-align: left;" trbidi="on">
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Palliative care and pain relief continue to remain neglected elements of global healthcare, according to a major new article <a href="http://www.thelancet.com/commissions/palliative-care" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">published online</a> October 13 in the <em style="box-sizing: border-box;">Lancet.</em></div>
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The report is the first to provide a worldwide estimate of the extent of serious suffering related to illness and injury and the resultant need for palliative care and pain relief.</div>
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More than 25.5 million people die every year without adequate relief for serious physical and psychological suffering ― nearly half of all deaths reported in 2015.</div>
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The report also states that an additional 35.5 million people require pain relief for reasons other than end-of-life care. The vast majority of these patients (>80%) live in low- and middle-income countries, where access to immediate-release morphine, an essential and inexpensive drug to relieve pain, is severely lacking.</div>
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Writing in a <a href="http://www.thelancet.com/commissions/palliative-care" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">linked commentary</a>, Richard Horton, MD, editor-in-chief of the <em style="box-sizing: border-box;">Lancet</em>, notes, "Death and disability are important metrics for describing the state of the world's health. But suffering is important too.</div>
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"Measures of suffering have been absent, and so the need for palliative care and pain relief services has been easy to miss," writes Dr Horton. "That excuse no longer holds. The scale of human suffering is massive ― 61 million people in 2015 and 6 billion physical and psychological symptom days annually (4 out of 5 of these days being accumulated in low-income and middle-income settings).</div>
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<span style="box-sizing: border-box; font-family: proxima_nova_ltlight, sans-serif;">The scale of human suffering is massive.</span> <span class="calloutauthor" style="box-sizing: border-box; display: inline-block; font-family: proxima_nova_ltsemibold, sans-serif; font-size: 0.8125rem; padding: 17px 20px 0px 200px;">Dr Richard Horton</span></div>
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"The Commission has uncovered an appalling oversight in global health," he adds. "It is time for that oversight to be remedied."</div>
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A previous <a href="https://www.medscape.com/viewarticle/815362" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">report</a> initiated several years ago by the Palliative Care Working Group of the European Society for Medical Oncology (ESMO) showed that millions of cancer patients around the world are not receiving adequate pain relief with opioid analgesics because of regulatory restrictions and a lack of access and availability.</div>
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More than half of the global population resides in nations where there are legal and bureaucratic restrictions on opioid drugs. The restrictions were introduced to stop abuse and drug trafficking, but they also prevent patients from receiving pain relief. An estimated 5 billion people live in countries with little or no access to pain relief, even for those with advanced disease.</div>
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The ESMO report focused on cancer; the new report is more extensive.</div>
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<span style="box-sizing: border-box;">Barriers to Care</span></h3>
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The report from the <em style="box-sizing: border-box;">Lancet</em> Commission on Global Access to Palliative Care and Pain Relief resulted from a 3-year project that involved 61 coauthors from 25 countries. The participants developed a new conceptual framework for measuring the global burden of serious health-related suffering (SHS). They analyzed 20 life-threatening and life-limiting health conditions (including HIV, cancers, cardiovascular disease, injuries, and dementia) and 15 corresponding symptoms (including pain, fatigue, wounds, anxiety, and depression) that are frequently associated with the need for palliative care and pain relief.</div>
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The commission then identified cost-effective interventions for providing pain relief and palliative care.</div>
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Barriers to pain relief and palliative care are multifactorial. One is that the focus of existing measures of health outcomes is on extending life and productivity; very little attention is given to interventions that alleviate pain or increase dignity at the end of life.</div>
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A second is "opiophobia," or the existing prejudice and misinformation surrounding the appropriate medical use of opioids. Related to this is a concern for preventing the nonmedical use of internationally controlled substances "without balancing the human right to access medicines to relieve pain." The cost for delivering morphine-equivalent pain medication for all children with SHS residing low-income countries is $1 million per year, but that is a "pittance" compared with the $100 billion spent globally to enforce prohibition of drug use, the commission notes.</div>
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Other barriers that were identified include the focus on cure and extending life in medicine while neglecting caregiving and patient quality of life as patients near death, and an overall global neglect of noncommunicable diseases, which account for much of the need for palliative care.</div>
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<span style="box-sizing: border-box;">Haves and Have Nots</span></h3>
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Another issue highlighted by the commission is the profound inequality in access to morphine for palliative care. The average distribution of morphine equivalent opioids in 2010-2013 was 298.5 metric tons, but only 0.1 metric tons were distributed to low-income countries.</div>
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For example, the distribution to Haiti, one of the world's poorest nations, is 5 mg per SHS patient, which, by extrapolation, means that 99% of the need is going unmet. Wealthy countries get the lion's share. In the United States, the annual distribution of morphine is 55,000 mg per patient; in Canada, its 68,000 mg.</div>
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Mexico meets 36% of its need for pain/palliative care medication; China meets 16%; India, 4%; and Nigeria, 0.2%. But for many of the poorest nations, oral morphine in palliative care is virtually nonexistent.</div>
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As <a href="https://www.medscape.com/viewarticle/859527" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">previously reported</a> by <em style="box-sizing: border-box;">Medscape Medical News,</em> an analysis conducted by the International Narcotics Control Board (INCB) that was published last year showed that the use of opioid analgesics has substantially increased in many regions, but this use is decidedly unbalanced globally.</div>
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The worldwide use of opioid analgesic medicines doubled between the periods 2001-2003 and 2011-2013, but this increase in use was largely confined to North America, western and central Europe, and Oceania.</div>
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The INCB report shows that about 92% of morphine used worldwide is consumed by only 17% of the population, primarily in the United States, Canada, Western Europe, Australia, and New Zealand, where consumption has increased significantly since the early 1990s and where there is growing concern about prescription drug abuse.</div>
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In the current <em style="box-sizing: border-box;">Lancet</em> report, the authors used Western Europe as a benchmark, because in many of the countries there, patients have appropriate access to opioid analgesics for both palliative care and other healthcare needs. In the United States, national levels of access exceed the European benchmark, and inappropriate prescribing and misuse/abuse of opioids have been <a href="https://www.medscape.com/viewarticle/871696" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">highlighted</a> as an opioid epidemic, many patients do not receive adequate pain medication.</div>
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The cost of meeting the global need for oral morphine for palliative care, if the same prices were available for low- and middle-income countries as high-income countries, would be only $145 million. The commission notes that this is "equivalent to a very small fraction (0.002%) of total public health expenditure."</div>
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For low-income countries alone, the cost would be only $13 million, provided the drugs were available at the same price.</div>
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<span style="box-sizing: border-box;">Key Messages</span></h3>
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Overall, the commission presented several key messages in their report:</div>
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Alleviating the burden of pain, suffering, and severe distress that is associated with life-threatening or life-limiting health conditions and with end of life is a global health and equity imperative.</div>
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An affordable "Essential Package" of palliative care and pain relief interventions can ameliorate a large portion of preventable burden of SHS. The Essential Package would include essential medications that are generally available in most countries, as well as interventions for the relief of social and spiritual suffering, and can be made universally accessible.</div>
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A solution to increasing access to palliative care/pain relief is to publicly fund and fully integrate the Essential Package into national health systems as part of universal health coverage. Cost-effective models can be applied in all countries.</div>
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Action on an international level is needed to ensure that all patients have access to palliative care and pain relief, and a "well-functioning and balanced global system" must prevent misuse and abuse of medications while ensuring appropriate and adequate access to essential medicines.</div>
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Better evidence and priority-setting tools are needed to adequately measure the global need for palliative care, implement policies and programs, and monitor progress toward alleviating the burden of pain and other types of SHS.</div>
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"Safeguards need to be in place to ensure that opioid analgesics are not diverted for nonmedical use, and national experiences from many countries in Europe and from programs in Africa, Asia, and Latin Americas prove to us that safe access is achievable," said Felicia Knaul, PhD, co-chair of the commission, in a statement.</div>
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"In other words, we can and must replicate the best of the models that are working taking lessons from many countries in Western Europe," explained Dr Knaul, who is a professor in the Department of Public Health Sciences at the University of Miami in Florida. "Some 60 million sick and suffering people are counting on all of us for help."</div>
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<em style="box-sizing: border-box;">The Lancet Commission was financially supported by the University of Miami Institute for Advanced Study of the Americas, the Harvard Global Equity Initiative, and the Office of the President and Provost at Harvard University and received grant support from the American Cancer Society, CRDF Global, the JM Foundation, the Mayday Fund, the National Cancer Institute, the Pan American Health Organization, and Susan G. Komen, and unrestricted gift support from Pfizer to the University of Miami and the Harvard T. H. Chan School of Public Health. Funds were also provided to Fundación Mexicana para la Salud, AC, and institutional support was provided by Fundación Mexicana para la Salud, AC, Tómatelo a Pecho, AC, and Harvard T. H. Chan School of Public Health. Dr Knaul and several coauthors have disclosed relationships with industry, as listed in the original article. Dr Horton has disclosed no relevant financial relationships.</em></div>
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<em style="box-sizing: border-box;">Lancet.</em> Published online October 13, 2017. <a href="http://www.thelancet.com/commissions/palliative-care" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">Full text</a>, <a href="http://www.thelancet.com/commissions/palliative-care" style="box-sizing: border-box; color: #5757a6; text-decoration-line: none;">Commentary</a></div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-45042913862327498782013-05-01T03:52:00.003-07:002013-05-01T03:52:37.946-07:00Bronchiectasis Linked to Higher Mortality in COPD Patients<div dir="ltr" style="text-align: left;" trbidi="on">
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Smoking, pulmonary hypertension, and a decline in lung function are associated with an increased risk of death in people with chronic obstructive pulmonary disease (COPD). Now researchers in Spain have added another potential risk factor: the presence and severity of bronchiectasis.</div>
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Compared with unaffected patients with COPD, patients with bronchiectasis had more than double the risk of dying than those without, according to a prospective, observational study published online February 8 in the <i>American Journal of Respiratory and Critical Care Medicine</i>.</div>
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Miguel Angel Martínez-García, MD, from the Pneumology Service at the University and Polytechnic La Fe Hospital in Valencia, Spain, and colleagues assessed 201 participants with moderate to severe COPD from a consecutive series of outpatients diagnosed at 1 of 2 specialty clinics in Spain. The mean age of participants was 70 years, and 91% were men. A majority (77%) featured radiologic signs of emphysema. Patients were diagnosed between January 2004 and February 2007.</div>
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"Patients with bronchiectasis in our series were 2.5 times more likely to die than those without bronchiectasis, independently of other variables," the researchers write.</div>
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Of the participants, 115 (57%) presented with bronchiectasis, which is defined "as a permanent and progressive dilation of the airways." The researchers followed up the participants every 3 to 6 months for a median of 48 months. Mortality risk among these patients with bronchiectasis was higher compared with that for the 86 unaffected patients (unadjusted hazard ratio, 4.07; 95% confidence interval, 1.9 - 8.7; <i>P</i> = .0001).</div>
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Bronchiectasis remained an independent factor after adjustment for dyspnea (Medical Research Council Dyspnea Scale), partial pressure of oxygen, body mass index, presence of potentially pathogenic microorganisms in sputum, presence of daily sputum production, number of severe exacerbations and peripheral albumin, and ultrasensitive C-reactive protein concentrations (adjusted hazard ratio, 2.54; 95% confidence interval, 1.16 - 5.56; <i>P</i> = .02). Age, Charlson Index, and postbronchodilator forced expiratory volume in 1 second (%) were also significantly associated with mortality in the adjusted model.</div>
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"The results of this study confirm a high prevalence of bronchiectasis in moderate-to-severe COPD patients and suggest that bronchiectasis is independently associated with an increased risk of all-cause mortality in these patients," the authors write.</div>
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The 51 deaths during follow-up were attributed to respiratory causes (32 patients), cardiovascular disease (11), malignant disease (5), and other causes (3 patients). Other factors that can influence mortality in patients with COPD were not assessed (eg, inactivity or pulmonary hypertension), which is a limitation of the study.</div>
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Use of bronchiectasis as a new factor for prognosis would "have a major clinical impact," the authors note. Detection of bronchiectasis with high-resolution computed tomography scans is reliable, and, once identified, patients can be treated with effective therapy to combat the chronic bronchial inflammation and infection.</div>
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"The pathogenic vicious circle of infection-inflammation leading to the formation of bronchiectasis can probably be broken by the early identification of this subgroup of patients with COPD and bronchiectasis and the establishment of early treatment, probably focusing on bronchial colonization by [potentially pathogenic microorganisms]."</div>
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Therefore, high-resolution computed tomography chest imaging should be considered for patients with COPD who are at higher risk for bronchiectasis, according to the investigators. Severe disease, multiple or severe exacerbations of COPD, and chronic colonization by potentially pathogenic microorganisms can elevate the risk. Further studies are warranted to confirm the results and to clarify the association between bronchiectasis and COPD exacerbations, the authors note.</div>
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<i>This study was supported by Praxis Pharmaceutical. The authors have disclosed no relevant financial relationships.</i></div>
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Unknownnoreply@blogger.com1tag:blogger.com,1999:blog-7957689159864253838.post-46990631705331375722013-05-01T03:52:00.001-07:002013-05-01T03:52:32.558-07:00Bronchiectasis Linked to Higher Mortality in COPD Patients<div dir="ltr" style="text-align: left;" trbidi="on">
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Smoking, pulmonary hypertension, and a decline in lung function are associated with an increased risk of death in people with chronic obstructive pulmonary disease (COPD). Now researchers in Spain have added another potential risk factor: the presence and severity of bronchiectasis.</div>
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Compared with unaffected patients with COPD, patients with bronchiectasis had more than double the risk of dying than those without, according to a prospective, observational study published online February 8 in the <i>American Journal of Respiratory and Critical Care Medicine</i>.</div>
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Miguel Angel Martínez-García, MD, from the Pneumology Service at the University and Polytechnic La Fe Hospital in Valencia, Spain, and colleagues assessed 201 participants with moderate to severe COPD from a consecutive series of outpatients diagnosed at 1 of 2 specialty clinics in Spain. The mean age of participants was 70 years, and 91% were men. A majority (77%) featured radiologic signs of emphysema. Patients were diagnosed between January 2004 and February 2007.</div>
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"Patients with bronchiectasis in our series were 2.5 times more likely to die than those without bronchiectasis, independently of other variables," the researchers write.</div>
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Of the participants, 115 (57%) presented with bronchiectasis, which is defined "as a permanent and progressive dilation of the airways." The researchers followed up the participants every 3 to 6 months for a median of 48 months. Mortality risk among these patients with bronchiectasis was higher compared with that for the 86 unaffected patients (unadjusted hazard ratio, 4.07; 95% confidence interval, 1.9 - 8.7; <i>P</i> = .0001).</div>
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Bronchiectasis remained an independent factor after adjustment for dyspnea (Medical Research Council Dyspnea Scale), partial pressure of oxygen, body mass index, presence of potentially pathogenic microorganisms in sputum, presence of daily sputum production, number of severe exacerbations and peripheral albumin, and ultrasensitive C-reactive protein concentrations (adjusted hazard ratio, 2.54; 95% confidence interval, 1.16 - 5.56; <i>P</i> = .02). Age, Charlson Index, and postbronchodilator forced expiratory volume in 1 second (%) were also significantly associated with mortality in the adjusted model.</div>
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"The results of this study confirm a high prevalence of bronchiectasis in moderate-to-severe COPD patients and suggest that bronchiectasis is independently associated with an increased risk of all-cause mortality in these patients," the authors write.</div>
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The 51 deaths during follow-up were attributed to respiratory causes (32 patients), cardiovascular disease (11), malignant disease (5), and other causes (3 patients). Other factors that can influence mortality in patients with COPD were not assessed (eg, inactivity or pulmonary hypertension), which is a limitation of the study.</div>
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Use of bronchiectasis as a new factor for prognosis would "have a major clinical impact," the authors note. Detection of bronchiectasis with high-resolution computed tomography scans is reliable, and, once identified, patients can be treated with effective therapy to combat the chronic bronchial inflammation and infection.</div>
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"The pathogenic vicious circle of infection-inflammation leading to the formation of bronchiectasis can probably be broken by the early identification of this subgroup of patients with COPD and bronchiectasis and the establishment of early treatment, probably focusing on bronchial colonization by [potentially pathogenic microorganisms]."</div>
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Therefore, high-resolution computed tomography chest imaging should be considered for patients with COPD who are at higher risk for bronchiectasis, according to the investigators. Severe disease, multiple or severe exacerbations of COPD, and chronic colonization by potentially pathogenic microorganisms can elevate the risk. Further studies are warranted to confirm the results and to clarify the association between bronchiectasis and COPD exacerbations, the authors note.</div>
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<i>This study was supported by Praxis Pharmaceutical. The authors have disclosed no relevant financial relationships.</i></div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-27323892084921247272013-05-01T03:51:00.005-07:002013-05-01T03:51:58.415-07:00FDA Floats Draft Guidance for Alzheimer's Drug Development<div dir="ltr" style="text-align: left;" trbidi="on">
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The US Food and Drug Administration (FDA) today issued a proposal designed to assist companies focused on the development of new treatments for patients in the early stages of Alzheimer's disease (AD).</div>
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"The scientific community and the FDA believe that it is critical to identify and study patients with very early Alzheimer's disease before there is too much irreversible injury to the brain," Russell Katz, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a statement announcing the draft proposal. "It is in this population that most researchers believe that new drugs have the best chance of providing meaningful benefit to patients," he added.</div>
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The <a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM338287.pdf" style="color: #5757a6; text-decoration: none;" target="_blank">guidance document</a> outlines the FDA's current thinking about how best to identify and select patients with early AD, or those who are at risk of developing the disease, for enrollment in clinical trials, the FDA explains.</div>
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The proposal addresses the selection of endpoints for clinical trials in these populations, as well as the manner in which disease modification might be demonstrated.</div>
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"We recognize that the standard approaches to the selection of outcome measures historically used in the development of treatments for dementia of the Alzheimer's type have major limitations when applied to clinical trials enrolling patients in the early clinical stages of the disease, or before clinical impairment has emerged at all," the proposal states. "This guidance addresses some possible adaptations of the current approach to drug development for the treatment of the dementia stage of AD that appear more appropriate for clinical trials in the early stages of the illness."</div>
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<b>A Tool for Discussion</b></div>
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"This draft guidance," Dr. Katz emphasized, "is intended to serve as a focus for continued discussions between the FDA and pharmaceutical sponsors, the academic community, advocacy groups, and the public. The FDA is committed to vigorously addressing Alzheimer's disease and will work with industry to help develop new treatments in this early population as expeditiously as possible."</div>
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The design of clinical trials specifically focused on the treatment of patients with established AD dementia (ie, dementia of the Alzheimer's type), or any of the autosomal dominant forms of Alzheimer's, is not explicitly discussed in the guidance, "although many of the principles in this guidance will be pertinent to this setting as well," the FDA notes.</div>
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The agency is seeking public comment on the draft guidance for 60 days. Instructions on how to submit comments are included in a related <em>Federal Register</em> notice <a href="https://s3.amazonaws.com/public-inspection.federalregister.gov/2013-02863.pdf" style="color: #5757a6; text-decoration: none;" target="_blank">issued today</a>.</div>
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The FDA proposal is part of the US Department of Health and Human Services' (HHS's) efforts under the National Plan to Address Alzheimer's Disease, which calls for both the government and the private sector to intensify efforts to treat or prevent Alzheimer's and related dementias and to improve care and services.</div>
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The proposal responds to recommendations from a May 2012 HHS and National Institutes of Health Alzheimer's research summit to conduct clinical trials in at-risk individuals without symptoms and to develop and validate new measures so that Alzheimer's can be measured at the earliest possible time in the course of the disease.</div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-54989877772614496502013-05-01T03:51:00.001-07:002013-05-01T03:51:02.839-07:00New estimates suggest that there were 4.7 million individuals aged 65 years or older with Alzheimer's disease dementia in the US in 2010 and that this number will triple to 13.8 million by 2050. These latest estimates, published online February 6 in Neurology, were devised by a team from the Rush Institute for Healthy Aging, Chicago, Illinois. "These are staggering numbers," coauthor Jennifer Weuve, MPH, ScD, commented to Medscape Medical News. "The ramifications for society and family caregivers in particular are huge." "This is not really a surprise," she added. "It's a bit like climate change. We've known about it for years but we haven't done much to stop it. Our data drum home the message that research into the prevention and treatment of Alzheimer's must be a priority, as well as developing better ways of managing patients with the condition and helping caregivers." A Complicated Task Weuve explained that trying to estimate the number Alzheimer's cases in the country is a complicated task because medical and public health agencies are not good at documenting these statistics. In addition, Alzheimer's is hugely underdiagnosed. She elaborated: "A diagnosis of Alzheimer's requires that you show up in a clinic and a physician actually thinks about dementia. Many patients go to their primary care doctor for something else, and although they may come across as confused, the doctor just puts this down to age and never formally diagnoses Alzheimer's, so about half of Alzheimer's cases go undiagnosed. Because of this, we had to be resourceful when trying to work out how many cases there actually were." To get around this problem, Weuve and her colleagues based their estimates on a sample of 10,000 older adults, aged 65 years and older, who actually underwent neurologic testing as part of the Chicago Health and Aging Project, a longitudinal, population-based study. Information from Industry Rebif® (interferon beta-1a): Update your knowledge Explore efficacy data They then worked out the prevalence of Alzheimer's disease according to age, sex, educational level, and race. By using US census data, this information was translated to the national population of the United States. Of the 4.7 million individuals with Alzheimer's in 2010, the researchers estimated that 0.7 million were 65 to 74 years, 2.3 million were 75 to 84 years, and 1.8 million were 85 years or older. With further use of census data, they then calculated how the older adult population will change over the next 40 years, and applied the 2010 prevalence data to future populations. This gave an estimate of 13.8 million people with Alzheimer's in 2050, of whom 7 million would be aged 85 years or older. This work was funded by the Alzheimer's Association and a grant from National Institutes of Health/National Institute on Aging. The authors have disclosed no relevant financial relationships.<div dir="ltr" style="text-align: left;" trbidi="on">
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There is no link between work-related stress and several common cancer types, according to a meta-analysis <a href="http://www.bmj.com/content/346/bmj.f165" style="color: #5757a6; text-decoration: none;" target="_blank">published online</a> February 7 in <em>BMJ</em>.</div>
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An international team of researchers, led by Katriina Heikkilä, PhD, from the Finnish Institute of Occupational Health in Helsinki, found that it is unlikely that job stress is a risk factor for colorectal, lung, breast, or prostate cancer, and it is not associated with an overall risk for cancer (hazard ratio [HR], 0.97).</div>
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The researchers note that approximately 90% of cancers have been linked to environment and lifestyle, but evidence of associations with other factors, including psychosocial ones, is tentative. However, it is possible that one psychosocial factor — stress — plays a role in the development of cancer.</div>
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The physiological stress response is characterized by the secretion of more hypothalamic and pituitary stress hormones, the researchers explain. These stress biomarkers trigger and maintain chronic inflammation, which has been shown to play a role in the promotion and progression of cancer.</div>
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Work and work-related factors are sources of stress for many people, explained Dr. Heikkilä. Of course, work can also be beneficial to a person's well being.</div>
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"We used a well-known, validated, harmonized measure of work stress, called job strain, which is defined as high demands and low control over work, and found that this measure is not associated with cancer risk," she told <em>Medscape Medical News</em>. There are a number of possible reasons for this.</div>
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One could be related to the duration of exposure to work stress, she pointed out. "It is not known how long a person needs to be exposed to stress for it to be harmful to health, but one would think that longer exposure would be worse than shorter," she said.</div>
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"In our study, work-related stress was measured at one point in time; thus, some of the participants had been exposed to stress for longer than others," Dr. Heikkilä said. "It would be interesting to [determine] whether the duration of stress exposure is relevant to the risk for cancer or other diseases," she noted.</div>
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It might be that work-related stress alone is not sufficient to contribute to cancer development, and that a combination of stressful factors (such as stress from adverse life events and caregiver stress) is needed, Dr. Heikkilä explained.</div>
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"It is also possible that stress — at work or elsewhere — is related to the risk for some rarer types of cancer, which we did not investigate in our study," she added.</div>
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<b>Not Related to Job Strain</b></div>
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To ascertain whether work-related psychosocial stress is associated with the risk for cancer, Dr. Heikkilä and colleagues conducted a meta-analysis of harmonized data from 12 independent prospective European studies. The studies were conducted in Denmark, Finland, France, the Netherlands, Sweden, and the United Kingdom from 1985 to 2008, and involved more than 116,000 participants.</div>
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All of the studies analyzed were part of the individual-participant-data meta-analysis in working populations (IPD)-Work consortium. The consortium consisted of a predefined 2-stage data-acquisition protocol. In the first stage, work stress, sociodemographic, and lifestyle baseline data were harmonized. Stage 2 linked the data to disease outcomes, including cancer.</div>
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In the meta-analysis, individuals who were diagnosed with cancer before the study period were excluded, as were those who were diagnosed during the first year of follow-up. This was done avoid reverse causality, in which symptoms of an undiagnosed cancer cause stress at work.</div>
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For those included in the analysis, complete data were available for job strain, age, sex, socioeconomic status, body mass index, smoking status, alcohol intake, and incident cancer outcomes. At study baseline, participants were 17 to 70 years. Within the cohort, 5765 (5%) developed some type of cancer during the average follow-up of 12 years (522 developed colorectal cancer, 374 developed lung cancer, 1010 developed breast cancer, and 865 developed prostate cancer).</div>
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In all studies included in the meta-analysis, work-related psychosocial stress was defined as job strain. Questions from validated questionnaires, such as the Job Content Questionnaire and Demand–Control Questionnaire, were used to ascertain baseline job strain.</div>
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The researchers found that, after adjustment for age and sex, job strain was not associated with the overall risk for cancer (HR for any cancer, 0.95). There was also no association after multivariable adjustment (HR, 0.97). The associations were similar in analyses that included nonmelanoma skin cancer and those that excluded it.</div>
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The researchers also found no association between job strain and the risk for colorectal (HR, 1.16), lung (HR, 1.17), breast (HR, 0.97), or prostate (HR, 0.86) cancer. Thus, clear evidence demonstrating an association between job strain and the risk of cancer is lacking.</div>
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<em>The IPD-Work Consortium is supported by the EU New OSHERA research program (funded by the Finnish Work Environment Fund, the Swedish Research Council for Working Life and Social Research, and the Danish National Research Centre for the Working Environment), the Academy of Finland, the BUPA Foundation (grant 22094477), and the Economic and Social Research Council in the United Kingdom. The authors have disclosed no relevant financial relationships.</em></div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7957689159864253838.post-56176642528616274952013-05-01T03:49:00.001-07:002013-05-01T03:49:43.643-07:00Alzheimer's Cases to Triple by 2050<div dir="ltr" style="text-align: left;" trbidi="on">
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New estimates suggest that there were 4.7 million individuals aged 65 years or older with Alzheimer's disease dementia in the US in 2010 and that this number will triple to 13.8 million by 2050.</div>
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These latest estimates, <a href="http://www.neurology.org/content/early/2013/02/06/WNL.0b013e31828726f5.abstract" style="color: #5757a6; text-decoration: none;" target="_blank">published online</a> February 6 in<em>Neurology</em>, were devised by a team from the Rush Institute for Healthy Aging, Chicago, Illinois.</div>
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"These are staggering numbers," coauthor Jennifer Weuve, MPH, ScD, commented to <em>Medscape Medical News</em>. "The ramifications for society and family caregivers in particular are huge."</div>
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"This is not really a surprise," she added. "It's a bit like climate change. We've known about it for years but we haven't done much to stop it. Our data drum home the message that research into the prevention and treatment of Alzheimer's must be a priority, as well as developing better ways of managing patients with the condition and helping caregivers."</div>
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<b>A Complicated Task</b></div>
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Weuve explained that trying to estimate the number Alzheimer's cases in the country is a complicated task because medical and public health agencies are not good at documenting these statistics. In addition, Alzheimer's is hugely underdiagnosed.</div>
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She elaborated: "A diagnosis of Alzheimer's requires that you show up in a clinic and a physician actually thinks about dementia. Many patients go to their primary care doctor for something else, and although they may come across as confused, the doctor just puts this down to age and never formally diagnoses Alzheimer's, so about half of Alzheimer's cases go undiagnosed. Because of this, we had to be resourceful when trying to work out how many cases there actually were."</div>
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To get around this problem, Weuve and her colleagues based their estimates on a sample of 10,000 older adults, aged 65 years and older, who actually underwent neurologic testing as part of the Chicago Health and Aging Project, a longitudinal, population-based study.</div>
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They then worked out the prevalence of Alzheimer's disease according to age, sex, educational level, and race. By using US census data, this information was translated to the national population of the United States.</div>
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Of the 4.7 million individuals with Alzheimer's in 2010, the researchers estimated that 0.7 million were 65 to 74 years, 2.3 million were 75 to 84 years, and 1.8 million were 85 years or older.</div>
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With further use of census data, they then calculated how the older adult population will change over the next 40 years, and applied the 2010 prevalence data to future populations.</div>
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This gave an estimate of 13.8 million people with Alzheimer's in 2050, of whom 7 million would be aged 85 years or older.</div>
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<em>This work was funded by the Alzheimer's Association and a grant from National Institutes of Health/National Institute on Aging. The authors have disclosed no relevant financial relationships.</em></div>
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