EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JULY 5, 2016

Media Advisory: To contact Ezekiel J. Emanuel, M.D., Ph.D., call Katie Delach at 215-349-5964 or email katie.delach@uphs.upenn.edu.

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Euthanasia and physician-assisted suicide in the United States, Canada, and Europe are increasingly being legalized, but they remain relatively rare, and primarily involve patients with cancer, according to a study appearing in the July 5 issue of JAMA.

The ethics and legality of euthanasia and physician-assisted suicide (PAS) continue to be controversial. In the early 20th century, multiple attempts at legalization were defeated. Recently, several countries have legalized the practices, and a number of countries are considering legalization. Ezekiel J. Emanuel, M.D., Ph.D., of the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues examined the legal status of euthanasia and PAS and comprehensively reviewed all the available data on attitudes and practices.

The authors found that currently, euthanasia or PAS can be legally practiced in the Netherlands, Belgium, Luxembourg, Colombia, and Canada (nationally as of June 2016). Physician-assisted suicide, excluding euthanasia, is legal in 5 U.S. states (Oregon, Washington, Montana, Vermont, and California) and Switzerland. Public support for euthanasia and PAS in the United States has plateaued since the 1990s (range, 47 percent – 69 percent). In Western Europe, an increasing and strong public support for euthanasia and PAS has been reported; in Central and Eastern Europe, support is decreasing.

Between 0.3 percent to 4.6 percent of all deaths are reported as euthanasia or PAS in jurisdictions where they are legal. The frequency of these deaths increases after legalization. More than 70 percent of cases involved patients with cancer. Typical patients are older, white, and well-educated. Pain is mostly not reported as the primary motivation for seeking euthanasia or PAS. The main motivations appear to be psychological, fear of losing autonomy and no longer enjoying life’s activities and other forms of mental distress.  A large portion of patients receiving PAS in Oregon and Washington reported being enrolled in hospice or palliative care, as did patients in Belgium. In no jurisdiction was there evidence that vulnerable patients have been receiving euthanasia or PAS at rates higher than those in the general population.

Problems and complications with the performance of euthanasia or PAS—such as not dying, waking up from coma and seizures—occur, but the available data make it difficult to determine the precise rates, although they are more common in PAS than euthanasia. In jurisdictions that have legalized euthanasia or PAS, use of these procedures has increased but alleged slippery-slope cases, such as ending the life of patients who are minors or have dementia, appear to be a very small minority of cases.

In the United States, less than 20 percent of physicians report having received requests for euthanasia or PAS, and 5 percent or less have complied. In Oregon and Washington state, less than 1 percent of licensed physicians write prescriptions for PAS per year. In the Netherlands and Belgium, about half or more of physicians reported ever having received a request; 60 percent of Dutch physicians have ever granted such requests.

The authors note that data about the practices of assisted dying are limited. “Therefore, collecting reliable data to evaluate end-of-life practices should be prioritized in all countries, and not only in countries legalizing euthanasia or PAS. Only such studies can help determine whether and how symptom management differs between patients requesting euthanasia or PAS and those who do not request these interventions.”

(doi:10.1001/jama.2016.8499; the study is available pre-embargo to the media at the For the Media website)

Editor’s Note: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JULY 5, 2016

Media Advisory: To contact Samuel Frank, M.D., email communications@hms.harvard.edu.

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In a study appearing in the July 5 issue of JAMA, Samuel Frank, M.D., of Harvard Medical School, Boston, and the Huntington Study Group, and colleagues evaluated the efficacy and safety of the drug deutetrabenazine to control a prominent symptom of Huntington disease, chorea, which is an involuntary, sudden movement that can affect any muscle and flow randomly across body regions. Chorea can interfere with daily functioning and increase the risk of injury.

The drug tetrabenazine is the only U.S. Food and Drug Administration-approved therapy for treating chorea associated with Huntington disease. Despite established efficacy, tetrabenazine often requires 3-times-a-day dosing, and there may be some peak concentration-related neuropsychiatric symptoms, such as sedation, fatigue, anxiety or nausea. For this study, 90 adults diagnosed with Huntington disease and a certain level of chorea were randomly assigned to receive deutetrabenazine (n = 45) or placebo (n = 45). Deutetrabenazine or placebo was titrated to optimal dose level over 8 weeks and maintained for 4 weeks.

The researchers found that deutetrabenazine treatment significantly improved chorea control as measured by a chorea score. Significant improvement was also observed on measures of impression of change and physical functioning, although no improvement was observed on a balance test. Adverse event rates were similar for deutetrabenazine and placebo, including depression, anxiety and akathisia (a movement disorder).

The authors note that the difference in total maximal chorea score associated with deutetrabenazine treatment that was observed in this study is notable given the progressive decline in total maximal chorea score and total motor score that has been previously described as part of the natural history of Huntington disease.

“Further research is needed to assess the clinical importance of the effect size and to determine longer-term efficacy and safety.”

(doi:10.1001/jama.2016.8655; the study is available pre-embargo to the media at the For the Media website)

Editor’s Note: This study was supported by Auspex Pharmaceuticals, a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.

Note: Available pre-embargo at the For The Media website is an accompanying editorial, “Deutetrabenazine for Treatment of Chorea in Huntington Disease,” by Michael D. Geschwind, M.D., Ph.D., and Nick Paras, Ph.D., of the University of California, San Francisco.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JULY 5, 2016

Media Advisory: To contact Shannon S. Carson, M.D., call Caroline Curran at 984-974-1146 or email Caroline.Curran@unchealth.unc.edu.

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Among families of patients with chronic critical illness, the use of palliative care-led informational and emotional support meetings compared with usual care did not reduce anxiety or depression symptoms, according to a study appearing in the July 5 issue of JAMA.

Patients are considered to have developed chronic critical illness when they experience acute illness requiring prolonged mechanical ventilation or other life-sustaining therapies but neither recover nor die within days to weeks. It is estimated that chronic critical illness affected 380,000 patients in the United States in 2009. Family members of patients in the intensive care unit (ICU) experience emotional distress including anxiety, depression, and posttraumatic stress disorder (PTSD). Palliative care specialists are trained to provide emotional support, share information, and engage patients and surrogate decision makers in discussions of patient values and goals of care.

Shannon S. Carson, M.D., of the University of North Carolina School of Medicine, Chapel Hill, N.C., Judith E. Nelson, M.D., J.D., of the Memorial Sloan Kettering Cancer Center, New York, and colleagues randomly assigned adult patients requiring 7 days of mechanical ventilation and their family surrogate decision makers to at least 2 structured family meetings led by palliative care specialists and provision of an informational brochure (intervention), or provision of an informational brochure and routine family meetings conducted by ICU teams (control). There were 130 patients with 184 family surrogate decision makers in the intervention group and 126 patients with 181 family surrogate decision makers in the control group. The study was conducted at 4 medical ICUs.

Among 365 family surrogate decision makers, 312 completed the study. At 3 months, there was no significant difference in anxiety and depression symptoms between surrogate decision makers in the intervention group and the control group. Posttraumatic stress disorder symptoms were higher in the intervention group compared with the control group. There was no difference between groups regarding the discussion of patient preferences. The median number of hospital days for patients in the intervention vs the control group and 90-day survival were not significantly different.

Potential explanations for this lack of benefit may relate to the high perceptions of quality of communication, emotional support, and family satisfaction in the usual care control. “When informational support provided by the primary team is sufficient, additional focus on prognosis may not help and could further upset a distressed family, even when emotional support is concurrently provided,” the authors write. “Alternatively, the intervention may have been insufficient to overcome the high levels of family stress associated with having a relative with chronic critical illness.”

“These findings do not support routine or mandatory palliative care-led discussion of goals of care for all families of patients with chronic critical illness.”

(doi:10.1001/jama.2016.8474; the study is available pre-embargo to the media at the For the Media website)

Editor’s Note: This project was funded by a grant from the National Institute of Nursing Research. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.

Note: Available pre-embargo at the For The Media website is an accompanying editorial, “Strategies to Support Surrogate Decision Makers of Patients With Chronic Critical Illness,” by Douglas B. White, M.D., M.A.S., of the University of Pittsburgh School of Medicine.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JULY 5, 2016

Media Advisory: To contact Blayne Welk, M.D., M.Sc., email Jeff Renaud at jrenaud9@uwo.ca.

To place an electronic embedded link to this study in your story  This link for the study will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.8096

In a study appearing in the July 5 issue of JAMA, Blayne Welk, M.D., M.Sc., of Western University, London, Canada, and colleagues conducted a study to assess the association between gadolinium exposure and parkinsonism, a degenerative disorder of the central nervous system characterized by tremor and impaired muscular coordination.

Gadolinium-based contrast agents are used for enhancement during magnetic resonance imaging (MRI). Safety concerns have emerged over retained gadolinium in the globus pallidi (an area of the brain). Neurotoxic effects have been seen in animals and when gadolinium is given intrathecally (a type of method for administering a drug) in humans. Consequences of damage to the globus pallidi may include parkinsonian symptoms. For this study, multiple linked administrative databases from Ontario, Canada were used. All patients older than 66 years who underwent an initial MRI between April 2003 and March 2013 were identified. Patients who were exposed to gadolinium-enhanced MRIs were compared with patients who received non-gadolinium-enhanced MRIs.

Of the 246,557 patients undergoing at least 1 MRI (not of the brain or spine) during the study period, 99,739 (40.5 percent) received at least 1 dose of gadolinium. Among patients who underwent gadolinium-enhanced MRIs, 81.5 percent underwent a single study, and 2.5 percent underwent 4 or more gadolinium-enhanced studies. Incident parkinsonism developed in 1.2 percent of unexposed patients and 1.2 percent of those exposed to gadolinium. No significant association between gadolinium exposure and parkinsonism was found.

“This result does not support the hypothesis that gadolinium deposits in the globus pallidi lead to neuronal damage manifesting as parkinsonism. However, reports of other nonspecific symptoms (pain, cognitive changes) after gadolinium exposure require further study,” the authors write.

(doi:10.1001/jama.2016.8096; the study is available pre-embargo to the media at the For the Media website)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 28, 2016

Media Advisory: To contact Christiane E. Angermann, M.D., email Angermann_C@ukw.de.

To place an electronic embedded link to this study in your story  This link for the study will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.7635

In a study appearing in the June 28 issue of JAMA, Christiane E. Angermann, M.D., of University Hospital Wurzburg, Germany, and colleagues examined whether 24 months of treatment with the antidepressant escitalopram would improve mortality, illness, and mood in patients with chronic heart failure and depression.

Previous meta-analysis indicates that depression prevalence in patients with heart failure is 10 percent to 40 percent, depending on disease severity. Depression has been shown to be an independent predictor of mortality and rehospitalization in patients with heart failure, with incidence rates increasing in parallel with depression severity. Long-term efficacy and safety of selective serotonin reuptake inhibitors (SSRIs), which are widely used to treat depression, is unknown for patients with heart failure and depression.

For this study, 372 patients with chronic heart failure with reduced ejection fraction (a measure of heart function) and depression were randomly assigned to receive escitalopram or matching placebo in addition to optimal heart failure therapy. During a median participation time of 18.4 months (n = 185) for the escitalopram group and 18.7 months (n = 187) for the placebo group, the primary outcome of death or hospitalization occurred in 116 (63 percent) patients and 119 (64 percent) patients, respectively. There was no significant improvement on a measure of depression for patients in the escitalopram group.

“These findings do not support the use of escitalopram in patients with chronic systolic heart failure and depression,” the authors write.

(doi:10.1001/jama.2016.7207; the study is available pre-embargo to the media at the For the Media website)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 28, 2016

Media Advisory: To contact Peter E. Morris, M.D., email Laura Dawahare at laura.dawahare@uky.edu.

To place an electronic embedded link to this study in your story  This link for the study will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.7201

In a study appearing in the June 28 issue of JAMA, Peter E. Morris, M.D., of the University of Kentucky, Lexington, and colleagues compared outcomes for standardized rehabilitation therapy to usual intensive care unit (ICU) care for acute respiratory failure.

Acute respiratory failure is associated with high mortality and prolonged illness, with impaired physical function for many survivors. Interventions directed at lessening the profound muscle wasting in patients with acute respiratory failure are patient-centered. Such therapies designed to improve patient-reported weakness and impaired physical function could reduce recovery time in patients. Reports have suggested that a rehabilitation program, delivered by an ICU rehabilitation team, may be associated with reduced length of stay (LOS) and improved physical function, although findings to the contrary exist as well.

In this study, 300 patients admitted to an ICU with acute respiratory failure requiring mechanical ventilation were randomly assigned to standardized rehabilitation therapy (SRT; n=150) or usual care (n=150) with 6-month follow-up. Patients in the SRT group received daily therapy until hospital discharge, consisting of passive range of motion, physical therapy, and progressive resistance exercise. The usual care group received weekday physical therapy when ordered by the clinical team.

The researchers found that the median hospital LOS was 10 days for the SRT group and 10 days for the usual care group. There was no difference in duration of ventilation or ICU care. Functional-related and health-related quality-of-life outcomes were similar for the 2 study groups at hospital discharge.

(doi:10.1001/jama.2016.7201; the study is available pre-embargo to the media at the For the Media website)

Editor’s Note: This work was supported by the National Institutes of Health, National Institute of Nursing Research, and National Heart, Lung, and Blood Institute. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.

Note: Available pre-embargo at the For The Media website is an accompanying editorial, “The Challenging Task of Improving the Recovery of ICU Survivors,” by Shannon L. Goddard, M.D., and Neill K. J. Adhikari, M.D.C.M., M.Sc., of the University of Toronto, Ontario, Canada.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 28, 2016

Media Advisory: To contact Jochen Gensichen, M.D., M.Sc., M.P.H, email jochen.gensichen@med.uni-jena.de.

To place an electronic embedded link to this study in your story  This link for the study will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.7207
In a study appearing in the June 28 issue of JAMA, Jochen Gensichen, M.D., M.Sc., M.P.H, of Jena University Hospital, Jena, Germany, and colleagues randomly assigned 291 patients who survived sepsis (including septic shock) to usual care (n = 143) or to a 12-month intervention (n = 148) to assess whether the primary care-based intervention would improve mental health-related quality of life.

Sepsis is a major health problem worldwide. It has been estimated that sepsis occurred in 2 percent of hospitalized patients in the United States in 2008, and incidence is expected to increase further in the future, with an even higher incidence in developing countries. Survivors of sepsis face long-term consequences that diminish health-related quality of life and result in increased care needs in the primary care setting, such as medication, physiotherapy, or mental health care.

For this study, usual care was provided by the patient’s primary care physician (PCP) and included periodic contacts, referrals to specialists, and prescription of medication, other treatment, or both. The intervention additionally included PCP and patient training, case management provided by trained nurses, and clinical decision support for PCPs by consulting physicians. At 6 and 12 months after intensive care unit discharge, 75 percent and 69 percent of patients, respectively, completed follow-up. The researchers found there was no significant difference in change of scores that measured mental health-related quality of life.

“Further research is needed to determine if modified approaches to primary care management may be more effective,” the authors write.

(doi:10.1001/jama.2016.7207; the study is available pre-embargo to the media at the For the Media website)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Note: Available pre-embargo at the For The Media website is an accompanying editorial, “The Challenging Task of Improving the Recovery of ICU Survivors,” by Shannon L. Goddard, M.D., and Neill K. J. Adhikari, M.D.C.M., M.Sc., of the University of Toronto, Ontario, Canada.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 28, 2016

Media Advisory: To contact Isabelle Boutron, M.D., Ph.D., email isabelle.boutron@aphp.fr.

To place an electronic embedded link to this study in your story  This link for the study will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.6310

In a study appearing in the June 28 issue of JAMA, Isabelle Boutron, M.D., Ph.D., of Paris Descartes University, Paris, and colleagues investigated the proportion of randomized clinical trials (RCTs) registered at ClinicalTrials.gov that were listed at the Clinical Study Data Request website, where companies voluntarily list studies for which data can be requested.

Access to individual patient-level data from clinical trials could be an important step forward in clinical research. Some pharmaceutical companies have committed to share such data. The largest repository is the Clinical Study Data Request (CSDR) website. To evaluate the completeness of data sharing on CSDR, the researchers studied all drugs other than vaccines listed on CSDR by all sponsors actively involved in data sharing, defined as listing at least 100 studies in June 2014.

For the 61 targeted drugs from 4 sponsors (drugs: Roche, 13; Lilly, 3; Boehringer Ingelheim, 5; GlaxoSmithKline [GSK], 40), 966 RCTs (462,751 participants) registered at ClinicalTrials.gov were identified; 512 RCTs (53 percent) (342,271 participants; i.e., 74 percent of the participants involved in these studies) were listed at CSDR. Records for 385 RCTs (40 percent) reported that all documents were available. The proportion of registered trials listed on CSDR varied from 33 percent for Roche to 66 percent for GSK and trials with all information available from 24 percent for Boehringer Ingelheim to 58 percent for GSK.

“Despite a delay of 18 months since the completion of drug trials by the company sponsor, only 53 percent of the RCTs from the 4 sponsors registered at ClinicalTrials.gov were listed at CSDR, with differences between sponsors. Data were available for a large number of participants, but an equally large amount of data was not available,” the authors write.

(doi:10.1001/jama.2016.6310; the study is available pre-embargo to the media at the For the Media website)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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EMBARGOED FOR RELEASE: 11 P.M. (ET) THURSDAY, JUNE 23, 2016

Media Advisory: To contact Yongjun Wang, M.D., email yongjunwang1962@gmail.com.

To place an electronic embedded link to this study in your story  This link for the study will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.8662

In a study published online by JAMA, Yongjun Wang, M.D., of Capital Medical University, Beijing, and colleagues examined the association between variants of the gene CYP2C19 and clinical outcomes of clopidogrel-treated patients with minor stroke or transient ischemic attack. The study is being released to coincide with its presentation at the Second Annual Scientific Session of the Chinese Stroke Association and the Tiantan International Stroke Conference in Beijing.

The Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events (CHANCE) trial showed that the combination of clopidogrel with aspirin compared with aspirin alone reduced the risk of stroke among patients with transient ischemic attack (TIA) or minor ischemic stroke who can be treated within 24 hours after the onset of symptoms. Clopidogrel, in combination with aspirin, has become a recommended treatment option for patients with TIA or acute minor stroke. Variations of the CYP2C19 gene have been identified as strong predictors of clopidogrel nonresponsiveness. Very limited data are available addressing the effect of CYP2C19 variants on clopidogrel efficacy in stroke, especially in Asian populations, in which the rates of stroke incidence and mortality are higher compared with white populations.

For this study, three CYP2C19 major variants were genotyped among 2,933 Chinese patients who were enrolled in the CHANCE trial. Overall, 1,207 patients (41 percent) were noncarriers and 1,726 patients (59 percent) were carriers of CYP2C19 variants. After day 90 follow-up, clopidogrel-aspirin reduced the rate of new stroke in the noncarriers but not in the carriers of the variants (events among noncarriers, 41[6.7 percent] with clopidogrel-aspirin vs 74 [12 percent] with aspirin; events among carriers, 80 [9.4 percent] with clopidogrel-aspirin vs 94 [11 percent] with aspirin).

Similar results were observed for the secondary efficacy outcome (a composite of vascular events [ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death]). The effect of treatment assignment on bleeding did not vary significantly between the carriers and the noncarriers of the genetic variants.

“These findings support a role of CYP2C19 genotype in the efficacy of this treatment,” the authors write.

The researchers note that it will be important to compare the association of CYP2C19 variants with efficacy of clopidogrel in a different population before applying these results to non-Asian populations, particularly given the variability in results of cardiovascular studies.

(doi:10.1001/jama.2016. 8662; the study is available pre-embargo to the media at the For the Media website)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) WEDNESDAY, JUNE 22, 2016

Media Advisory: To contact Simon Chapman, Ph.D., email simon.chapman@sydney.edu.au or call +(61) 438-340-304. To contact editorial author Daniel W. Webster, Sc.D., M.P.H., call Alicia Samuels at 914-720-4635 or email asamuels@jhu.edu.

To place electronic embedded links to this study and editorial in your story  Links will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.8752; http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.8819

In the 20 years since gun law reforms and buyback programs in Australia, there have been no mass shootings and a more rapid decline in total firearm deaths, according to a study published online by JAMA.

In 1996, Australia introduced sweeping gun laws following a mass shooting in which a man used 2 semiautomatic rifles to kill 35 people and wound 19 others. The new gun laws banned rapid-fire long guns (including those already in private ownership), explicitly to reduce their availability for mass shootings. In addition, by January 1997, all 6 states and 2 territories in Australia had begun a mandatory buyback at market price of prohibited firearms. From October 1997, large criminal penalties, including imprisonment and heavy fines, applied to possession of any prohibited weapon.

Simon Chapman, Ph.D., of the University of Sydney, Australia, and colleagues examined whether enactment of the 1996 gun laws and buyback program were followed by changes in the incidence of mass firearm homicides (defined as 5 or more victims, not including the perpetrator) and total firearm deaths. The researchers used Australian government statistics on deaths caused by firearms (1979-2013) and news reports of mass shootings in Australia (1979-May 2016).

From 1979-1996 (before gun law reforms), 13 fatal mass shootings occurred in Australia, whereas from 1997 through May 2016 (after gun law reforms), no fatal mass shootings occurred. There was also significant change in the preexisting downward trends for rates of total firearm deaths prior to vs after gun law reform. From 1979-1996, the average rate of total firearm deaths was 3.6 per 100,000 population (average decline of 3 percent per year), whereas from 1997-2013 the average rate of total firearm deaths was 1.2 per 100,000 population (average decline of 4.9 percent per year).

There was a statistically significant acceleration in the preexisting downward trend for firearm suicide, but this was not statistically significant for firearm homicide. From 1979-1996, the average annual rate of total nonfirearm suicide and homicide deaths was 10.6 per 100,000 population (average increase of 2.1 percent per year), whereas from 1997-2013, the average annual rate was 11.8 per 100,000 (average decline of 1.4 percent per year). There was no evidence of substitution of other lethal methods for suicides or homicides.

The researchers note that because there was a greater magnitude decline post-1996 in total nonfirearm suicide and homicide deaths than the decreases for suicide and homicide involving firearms, it is not possible to determine whether the change in firearm deaths can be attributed to the gun law reforms.

“We are unaware of any other nation that has enacted such a substantial change in gun laws as has been implemented in Australia. Comparative studies of Australia’s experience with broadly comparable nations would provide further evidence of the effects of such law reform,” the authors write.

(doi:10.1001/jama.2016.8752; the study is available pre-embargo to the media at the For the Media website)

Editor’s Note: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr. Chapman reported being a member of the Coalition for Gun Control (Australia) from 1993-1996. Mr. Alpers reported being director of GunPolicy.org.

Editorial: Lessons From Australia’s National Firearms Agreement

“What can the United States take away from the experience of Australia’s National Firearms Agreement (NFA) and the findings reported by Chapman et al? Political, cultural, and legal challenges make it highly unlikely that the United States would implement comparable policies,” writes Daniel W. Webster, Sc.D., M.P.H., of the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an accompanying editorial.

“Yet the experience in Australia over the past 2 decades since enactment of the NFA provides a useful example of how a nation can come together to forge life-saving policies despite political and cultural divides. Australia has comprehensive regulations to limit the misuse of handguns as well as long guns that are more restrictive than anywhere in the United States, even in those communities with the strictest gun laws. If U.S. firearm homicide rates were only 10 times as high as firearm homicide rates in Australia, rather than 23 times as high, there would be substantially fewer homicides.”

“There is evidence that some U.S. policies at the state level (e.g., handgun purchaser licensing, gun restrictions for domestic violence offenders, gun restrictions for violent misdemeanants, gun safe storage laws) are associated with reductions in firearm-related violence and fatalities. Research evidence should inform the way forward to advance the most effective policies to reduce violence. However, research alone will not be enough. Australian citizens, professional organizations, and academic researchers all played productive roles in developing and promoting evidence-informed policies and demanding that their lawmakers adopt measures to prevent the loss of life and terror of gun violence. Citizens in the United States should follow their lead.”

(doi:10.1001/jama.2016.8819; the editorial is available pre-embargo to the media at the For the Media website)

Editor’s Note: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr. Webster reported that the Johns Hopkins Center for Gun Policy and Research has previously received funding from Bloomberg Philanthropies to conduct and disseminate research to inform gun policy, and the center has a current grant from Everytown for Gun Safety to study Baltimore’s underground gun market.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 21, 2016

Media Advisory: To contact Dariush Mozaffarian, M.D., Dr.P.H., call Siobhan Gallagher at 617-636-6586 or email siobhan.gallagher@tufts.edu. To contact editorial author Margo A. Denke, M.D., email denke@att.net.

To place electronic embedded links to this study and editorial in your story  These links will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.7491; http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.7636

In nationally representative surveys conducted between 1999 and 2012, several improvements in self-reported dietary habits were identified, such as increased consumption of whole grains, with additional findings suggesting persistent or worsening disparities based on race/ethnicity and education and income level, according to a study appearing in the June 21 issue of JAMA.

Suboptimal diet is among the leading causes of poor health, particularly obesity, diabetes, cardiovascular diseases, and diet-related cancers. In the United States, dietary factors are estimated to account for more than 650,000 deaths per year and 14 percent of all disability-adjusted life-years lost. Understanding trends in dietary habits is crucial to inform priorities and policies to improve diets and reduce diet-related illness. Dariush Mozaffarian, M.D., Dr.P.H., of the Tufts Friedman School of Nutrition Science and Policy, Boston, and colleagues examined trends in overall diet quality and multiple dietary components related to major diseases using 24-hour dietary recalls in nationally representative samples that included 33,932 U.S. adults age 20 years or older from 7 National Health and Nutrition Examination Survey (NHANES) cycles (1999-2012). As a summary indicator, a diet score was constructed based on the American Heart Association (AHA) 2020 Strategic Impact Goals for diet.

The researchers found that many aspects of the U.S. diet improved, including increased consumption of whole grains, nuts or seeds, a slight increase in fish and shellfish and decreased consumption of sugar-sweetened beverages. Other dietary trends included increased consumption of whole fruit and decreased consumption of 100 percent fruit juice. No significant trend was observed for other diet score components, including total fruits and vegetables, processed meat, saturated fat, or sodium. The estimated percentage of U.S. adults with poor diets declined from 56 percent to 46 percent. The percentage with ideal diets increased but remained low (0.7 percent to 1.5 percent).

Disparities in diet quality were observed by race/ethnicity, education, and income level; for example, the estimated percentage of non-Hispanic white adults with a poor diet significantly declined (54 percent to 43 percent), whereas similar improvements were not observed for non-Hispanic black or Mexican American adults. There was little evidence of reductions in these disparities and some evidence of worsening by income level.

“These findings may inform discussions on emerging successes, areas for greater attention, and corresponding opportunities to improve the diets of individuals living in the United States,” the authors write.

(doi:10.1001/jama.2016.7491; the study is available pre-embargo to the media at the For the Media website)

Editor’s Note: This work was supported by a grant from the National Heart, Lung, and Blood Institute. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.

Editorial: Changing Dietary Habits and Improving the Healthiness of Diets in the United States

Margo A. Denke, M.D., formerly with the University of Texas Southwestern Medical Center, Dallas, comments on the findings of this study in an accompanying editorial.

“Achieving dietary changes remains a challenging task. The advice of clinicians may not provide lasting effects unless patients can incorporate meaningful dietary changes into a daily sustainable pattern. How to best accomplish this task is the goal. The article by Rehm et al provides a current dietary report card to help with this task. Even though there has been some improvement from 1999 to 2012, clinicians, patients, and the food industry all need to work together to meet the challenge of improving the healthiness of the U.S. diet.”

(doi:10.1001/jama.2016.7636; the editorial is available pre-embargo to the media at the For the Media website)

Editor’s Note: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 21, 2016

Media Advisory: To contact Taulant Muka, M.D., Ph.D., email t.muka@erasmusmc.nl or call +31-6-252-030-92 or +31-10-7044-228.

To place an electronic embedded link to this study in your story  This link for the study will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.8012

An analysis of more than 60 studies suggests that some plant-based therapies are associated with modest reductions in the frequency of hot flashes and vaginal dryness but no significant reduction in night sweats, according to a study appearing in the June 21 issue of JAMA.

Medical treatments for symptoms associated with menopause are available, including hormone replacement therapy. However, given the potentially negative health consequences of hormone replacement therapy on cardiovascular health and breast cancer, 40 percent to 50 percent of women in Western countries choose to use complementary therapies, including plant-based therapies. A broad range of plant-based therapies may improve menopausal symptoms. These therapies include the oral use of phytoestrogens such as dietary soy isoflavones and soy extracts; herbal remedies such as red clover and black cohosh; and Chinese and other medicinal herbs. Although associations of these therapies with menopausal symptoms have been evaluated in randomized trials, most of these studies were limited by sample size, a short follow-up period, suboptimal quality, and inconsistent findings.

Taulant Muka, M.D., Ph.D., of Erasmus University Medical Center, Rotterdam, the Netherlands, and colleagues, in collaboration with the University of Cambridge, conducted a review and meta-analysis of randomized clinical trials that assessed plant-based therapies and the presence of hot flashes, night sweats, and vaginal dryness. The researchers identified 62 studies (6,653 women) that met criteria for inclusion in the analysis.

Use of phytoestrogens was associated with a decrease in the number of daily hot flashes and vaginal dryness score between the treatment groups but not in the number of night sweats. Individual phytoestrogen interventions such as dietary and supplemental soy isoflavones were associated with improvement in daily hot flashes and vaginal dryness score. Several herbal remedies, but not Chinese medicinal herbs, were associated with an overall decrease in the frequency of vasomotor symptoms. There was substantial variation among the available studies in terms of scientific rigor and quality.

“Because of general suboptimal quality and the heterogeneous nature of the current evidence, further rigorous studies are needed to determine the association of plant-based and natural therapies with menopausal health,” the authors write.

(doi:10.1001/jama.2016.8012; the study is available pre-embargo to the media at the For the Media website)

Editor’s Note: This study was sponsored by Metagenics Inc. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 21, 2016

Media Advisory: To contact Matthew M. Davis, M.D., M.A.P.P., email Kara Gavin at kegavin@med.umich.edu.

To place an electronic embedded link to this study in your story  This link for the study will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.6303

In a study appearing in the June 21 issue of JAMA, Matthew M. Davis, M.D., M.A.P.P., of the University of Michigan, Ann Arbor, and colleagues examined changes in insurance coverage among hospitalized nonelderly adults after Michigan expanded Medicaid coverage in 2014 under the Affordable Care Act (ACA).

Using the Michigan Inpatient Database, the researchers compared insurance coverage for hospitalized patients during initial implementation of the Healthy Michigan Plan in April-December 2014 with corresponding months in 2012 and 2013 and examined patterns at the level of individual hospitals to ascertain whether the consequences of expanded coverage were uniform across institutions.

The analysis included 130 hospitals in Michigan that provide acute care. In April-December, uninsured patients represented 5.8 percent in 2012 and 6 percent in 2013 of nonelderly adult discharges compared with 2 percent in 2014. The proportion of discharges for nonelderly adults with Medicaid increased from 23 percent in 2012 and 24 percent in 2013 to 30 percent in 2014. The changes in proportions of discharges with private coverage and Medicare over the same period were smaller. Most of the changes in the proportions of uninsured and Medicaid discharges occurred in the first quarter of Medicaid expansion and remained stable for the rest of 2014.

In 94 percent of Michigan’s acute care hospitals, the proportion of discharges for uninsured patients was lower in 2014 compared with the average proportion of uninsured discharges for 2012 and 2013. Conversely, in 88 percent of those hospitals, the proportion of discharges for Medicaid patients in 2014 exceeded the average proportion of discharges with Medicaid for 2012 and 2013.

“The reductions in uninsured patients occurred without an increase in the number of hospitalized nonelderly adults, suggesting opportunities to reduce uncompensated care,” the authors write.

(doi:10.1001/jama.2016.6303; the study is available pre-embargo to the media at the For the Media website)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 21, 2016

Media Advisory: To contact Peter Ganz, M.D., email Scott Maier at Scott.Maier@ucsf.edu.

To place an electronic embedded link to this study in your story  This link for the study will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.5951

In a study appearing in the June 21 issue of JAMA, Peter Ganz, M.D., of the University of California-San Francisco, and colleagues conducted a study to develop and validate a score to predict risk of cardiovascular outcomes among patients with coronary heart disease using analysis of circulating proteins.

Coronary heart disease (CHD) remains a leading cause of death and illness. Precise stratification of cardiovascular risk in patients with CHD is needed to inform treatment decisions. This study included participants with stable CHD. For the derivation cohort (Heart and Soul study), outpatients from San Francisco were enrolled from 2000 through 2002 and followed up through November 2011. For the validation cohort (HUNT3, a Norwegian population-based study), participants were enrolled from 2006 through 2008 and followed up through April 2012. A protein risk score was derived and validated for 4-year probability of heart attack, stroke, heart failure, and all-cause death; 1,130 proteins were measured in plasma samples. The risk score was compared with variables (such as total cholesterol, systolic blood pressure, smoking status) from the Framingham secondary event risk model, refit to the cohorts in this study.

From the derivation cohort, 938 samples were analyzed; from the validation cohort, 971 samples were analyzed. The researchers identified 9 proteins associated with adverse cardiovascular outcomes and developed a risk score with these proteins that performed better than the refit Framingham secondary event risk score in predicting cardiovascular events, but still provided only modest discriminative accuracy.

“Further research is needed to assess whether the score is more accurate in a lower-risk population,” the authors write.

(doi:10.1001/jama.2016.5951; the study is available pre-embargo to the media at the For the Media website)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

FOR RELEASE: JUNE 15, 2016

Media Advisory: To contact the U.S. Preventive Services Task Force, email the Media Coordinator at Newsroom@USPSTF.net or call 202-572-2044.

To place an electronic embedded link to this report in your story  This is the link to the report: http://jama.jamanetwork.com/article.aspx?articleid=2529486

Note: A list of related content appears below.
 

The U.S. Preventive Services Task Force (USPSTF) found convincing evidence that colorectal cancer screening substantially reduces deaths from the disease among adults 50 to 75 years of age and that not enough adults in the United States are using this effective preventive intervention. About one-third of eligible adults in the United States have never been screened for colorectal cancer. The report appears in the June 21 issue of JAMA.

Colorectal cancer is the second leading cause of cancer death in the United States. In 2016, an estimated 134,000 persons will be diagnosed with the disease, and about 49,000 will die from it. To update its 2008 recommendation, the USPSTF reviewed the evidence on the effectiveness of several screening strategies, including colonoscopy, flexible sigmoidoscopy, computed tomography colonography, the guaiac-based fecal occult blood test, the fecal immunochemical test, and the multitargeted stool DNA test, in reducing the incidence of and mortality from colorectal cancer or all-cause mortality; the harms of these screening tests; and the test performance characteristics of these tests for detecting adenomatous polyps, advanced adenomas based on size, or both, as well as colorectal cancer. The USPSTF also commissioned a comparative modeling study to provide information on optimal starting and stopping ages and screening intervals across the different available screening methods.

The USPSTF is an independent, volunteer panel of experts that makes recommendations about the effectiveness of specific preventive care services such as screenings, counseling services, and preventive medications.

Detection

The USPSTF found convincing evidence that screening for colorectal cancer with several different methods can accurately detect early-stage colorectal cancer and adenomatous polyps. Although single test performance is an important issue in the detection of colorectal cancer, the sensitivity of the test over time is more important in an ongoing screening program.

Benefits of Screening and Early Intervention

The USPSTF found convincing evidence that screening for colorectal cancer in adults age 50 to 75 years reduces colorectal cancer mortality. The USPSTF found no head-to-head studies demonstrating that any of the screening strategies it considered are more effective than others, although the tests have varying levels of evidence supporting their effectiveness, as well as different strengths and limitations.

The benefit of early detection of and intervention for colorectal cancer declines after age 75 years. Among older adults who have been previously screened for colorectal cancer, there is at best a moderate benefit to continuing screening during the ages of 76 to 85 years. However, adults in this age group who have never been screened for colorectal cancer are more likely to benefit than those who have been previously screened. The time between detection and treatment of colorectal cancer and realization of a subsequent mortality benefit can be substantial. As such, the benefit of early detection of and intervention for colorectal cancer in adults 86 years and older is at most small. To date, no method of screening for colorectal cancer has been shown to reduce all-cause mortality in any age group.

Harms of Screening and Early Intervention

The harms of screening for colorectal cancer in adults 50 to 75 years of age are small. The majority of harms result from the use of colonoscopy, either as the screening test or as follow-up for positive findings detected by other screening tests. The rate of serious adverse events from colorectal cancer screening increases with age. Thus, the harms of screening for colorectal cancer in adults 76 years and older are small to moderate.

Recommendation

The USPSTF recommends screening for colorectal cancer starting at age 50 years and continuing until age 75 years (A recommendation; indicates that there is high certainty that the net benefit is substantial); and the decision to screen for colorectal cancer in adults aged 76 to 85 years should be an individual one, taking into account the patient’s overall health and prior screening history (C recommendation; indicates that there is at least moderate certainty that the net benefit is small).

(doi:10.1001/jama.2016.5989; the full report is available pre-embargo to the media at the For the Media website)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Note: More information about the U.S. Preventive Services Task Force, its process, and its recommendations can be found on the newsroom page of its website.

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Related Content from the JAMA Network:

• Screening for Colorectal Cancer: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force

• Estimation of Benefits, Burden, and Harms of Colorectal Cancer Screening Strategies: Modeling Study for the US Preventive Services Task Force

• Clinical Practice Guidelines for Colorectal Cancer Screening: New Recommendations and New Challenges

• Blood-Based Screening for Colon Cancer: A Disruptive Innovation or Simply a Disruption?

• Colorectal Cancer Screening: Which Test Is Best?

• Fecal Blood Testing or Colonoscopy: What Is the Best Method for Colorectal Cancer Screening?

Summary Video: Screening for Colorectal Cancer

JAMA Patient Pages: Screening for Colorectal Cancer; Screening Tests for Colorectal Cancer

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For more information, contact JAMA Network Media Relations at 312-464-JAMA (5262) or email mediarelations@jamanetwork.org.

EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 14, 2016

Media Advisory: To contact Angela Sauaia, M.D., Ph.D., call Mark Couch at 303-724-5377 or email Mark.Couch@ucdenver.edu.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.5978

In a study appearing in the June 14 issue of JAMA, Angela Sauaia, M.D., Ph.D., of the University of Colorado Anschutz Medical Campus, Aurora, and colleagues examined patterns of gunshot wound-associated severity and mortality at a Colorado urban trauma center.

Death rates provide an incomplete picture of the effect of firearm injuries. To devise appropriate prevention efforts, investigations of the severity and prognosis of both fatal and nonfatal gunshot wounds (GSW) are pivotal, yet they remain scarce. For this study, the researchers examined the state-mandated trauma registry of a level 1 trauma center (Denver Health Medical Center, DHMC) for data on injuries, cause, and severity for all patients who died in the hospital, were hospitalized, or required more than 12-hour observation from 2000 to 2013. Throughout this period, the DHMC catchment area was Denver County. To assess injury deaths at the scene (vs in-hospital), the authors obtained all Denver County records of trauma deaths during the same period.

From 2000 to 2013, 28,948 patients presented to the DHMC with injuries due to GSWs (6 percent), stabbings (6 percent), pedestrian accidents (7 percent), assaults (9 percent), falls (24 percent), motor vehicle crashes (26 percent), and other mechanisms (22 percent). Of these, 5.4 percent died. The proportions of DHMC injury admissions due to GSWs, stabbings, and assaults remained stable from 2000 to 2013, whereas falls increased and motor vehicle crashes decreased over time. Adjusted in-hospital case-fatality rates for GSWs at the DHMC significantly increased and the probability of trauma survival decreased. All other mechanisms presented stable or opposite trends for deaths and survival probability. Over time, more GSW patients had a high score on a measure of injury severity, and the number of severe GSWs per patient increased significantly.

The authors note that this single trauma center study has limited generalizability.

“Firearm in-hospital case-fatality rates increased, contrary to every other trauma mechanism, attributable to the rising severity and number of injuries,” the researchers write. “A renewed attention to research and policy are needed to decrease the morbidity and mortality of GSWs.”

(doi:10.1001/jama.2016. 5978; this study is available pre-embargo at the For The Media website.)

Editor’s Note: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

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For more information, contact JAMA Network Media Relations at 312-464-JAMA (5262) or email mediarelations@jamanetwork.org.

EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 14, 2016

Media Advisory: To contact  Siddharth Singh, M.D., M.S., call Michelle Brubaker at 619-471-9049 or email mmbrubaker@ucsd.edu.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.7602

In an analysis that included nearly 30,000 overweight or obese adults, compared with placebo, orlistat, lorcaserin, naltrexone-bupropion, phentermine-topiramate, and liraglutide were each associated with achieving at least 5 percent weight loss at 52 weeks, and phentermine-topiramate and liraglutide were associated with the highest odds of achieving at least 5 percent weight loss, according to a study appearing in the June 14 issue of JAMA.

Approximately 1.9 billion adults are overweight and 600 million are obese worldwide. Identifying effective long-term treatment strategies for overweight and obesity is of paramount importance. The U.S. Food and Drug Administration (FDA) has approved 5 weight loss drugs (orlistat, lorcaserin, naltrexone-bupropion, phentermine-topiramate, and liraglutide) for long-term use in obese (body mass index [BMI] ≥ 30) or overweight (BMI ≥ 27) individuals with at least 1 weight-associated condition (type 2 diabetes, hypertension, hyperlipidemia). Data on the comparative effectiveness of these drugs are limited.

Siddharth Singh, M.D., M.S., of the University of California, San Diego, La Jolla, and colleagues conducted a systematic review and meta-analysis of randomized clinical trials that included overweight and obese adults treated with FDA-approved long-term weight loss agents for at least 1 year compared with another active agent or placebo. Twenty-eight randomized clinical trials with 29,018 patients (median age, 46 years; 74 percent women; median baseline body weight, 222 lbs.; median baseline BMI, 36.1) were included.

The researchers found that a median 23 percent of placebo participants had at least 5 percent weight loss vs 75 percent of participants taking phentermine-topiramate, 63 percent of participants taking liraglutide, 55 percent taking naltrexone-bupropion, 49 percent taking lorcaserin, and 44 percent taking orlistat. All active agents were associated with significant excess weight loss compared with placebo at 1 year: phentermine-topiramate, 19.4 lbs.; liraglutide, 11.7 lbs.; naltrexone-bupropion, 11 lbs.; lorcaserin, 7.1 lbs.; and orlistat, 5.7 lbs. Compared with placebo, liraglutide and naltrexone-bupropion were associated with the highest odds of adverse event-related treatment discontinuation.

“Ultimately, given the differences in safety, efficacy, and response to therapy, the ideal approach to weight loss should be highly individualized, identifying appropriate candidates for pharmacotherapy, behavioral interventions, and surgical interventions. Historically, concerns regarding the long-term safety profile of pharmacotherapy for weight loss have limited their clinical use, particularly among medications with significant adrenergic actions or central appetite-suppressing actions. Short-term clinical trials may not provide comprehensive information on the long-term safety of these agents, and prospective postmarketing surveillance studies are warranted,” the authors write.

(doi:10.1001/jama.2016.7602; this study is available pre-embargo at the For The Media website.)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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For more information, contact JAMA Network Media Relations at 312-464-JAMA (5262) or email mediarelations@jamanetwork.org.

 EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 14, 2016

Media Advisory: To contact  Wayne A. Ray, Ph.D., call Craig Boerner at 615-322-4747 or email craig.boerner@vanderbilt.edu.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.7789

Prescription of long-acting opioids for chronic noncancer pain was associated with an increased risk of all-cause mortality, including deaths from causes other than overdose, compared with anticonvulsants or cyclic antidepressants, according to a study appearing in the June 14 issue of JAMA.

The increase in prescribing opioid analgesics for chronic noncancer pain has led to escalating concern about potential harms. Long-acting opioids increase the risk of unintentional overdose deaths but also may increase mortality from cardiorespiratory and other causes. Wayne A. Ray, Ph.D., of the Vanderbilt University School of Medicine, Nashville, Tenn., and colleagues compared the risk of death among patients initiating long-acting opioid therapy for moderate to severe chronic noncancer pain with that for matched patients initiating therapy with either an analgesic anticonvulsant or a low-dose cyclic antidepressant (medications that served as a control arm). The study included Tennessee Medicaid patients with chronic noncancer pain and no evidence of palliative or end-of-life care (1999 – 2012).

There were 22,912 new episodes of prescribed therapy for both long-acting opioids and control medications. The long-acting opioid group was followed up for an average 176 days and had 185 deaths and the control treatment group was followed up for an average 128 days and had 87 deaths. Analysis indicated that patients prescribed therapy for a long-acting opioid had a risk of all-cause mortality that was 1.6 times greater than that for matched patients starting an analgesic anticonvulsant or a low-dose cyclic antidepressant. The absolute risk difference was modest. The difference was explained by a 1.9 times greater risk of out-of-hospital deaths.  More than two-thirds of the excess deaths were due to causes other than unintentional overdose; of these, more than one-half were cardiovascular deaths. The increased risk was confined to the first 180 days of prescribed therapy but was present for long-acting opioid doses of 60 mg or less of morphine-equivalents.

“These findings should be considered when evaluating harms and benefits of treatment,” the authors write.

(doi:10.1001/jama.2016.7789; this study is available pre-embargo at the For The Media website.)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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For more information, contact JAMA Network Media Relations at 312-464-JAMA (5262) or email mediarelations@jamanetwork.org.

EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 7, 2016

Media Advisory: To contact Katherine M. Flegal, Ph.D., call the NCHS Press Office at 301-458-4800 or email paoquery@cdc.gov. To contact editorial co-author Jody W. Zylke, M.D., email Jim Michalski at jim.michalski@jamanetwork.org.

To place an electronic embedded link to this study and editorial in your story  These links will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.6458; http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.6190

The prevalence of obesity in 2013- 2014 was 35 percent among men and 40 percent among women, and between 2005 and 2014, there was an increase in prevalence among women, but not men, according to a study appearing in the June 7 issue of JAMA.

Between 1980 and 2000, the prevalence of obesity increased significantly among adult men and women in the United States; further significant increases were observed through 2003-2004 for men but not women. Subsequent comparisons of data from 2003-2004 with data through 2011-2012 showed no significant increases for men or women. To get a more comprehensive understanding of the trends in obesity, Katherine M. Flegal, Ph.D., of the National Center for Health Statistics, Centers for Disease Control and Prevention, Hyattsville, Md., and colleagues examined obesity prevalence for 2013-2014 and trends over the decade from 2005 through 2014, adjusting for sex, age, race/Hispanic origin, smoking status, and education. The researchers analyzed data obtained from the National Health and Nutrition Examination Survey (NHANES), a cross-sectional, nationally representative health examination survey of the U.S. civilian population that includes measured weight and height.

The analysis included data from 2,638 adult men (average age, 47 years) and 2,817 women (average age, 48 years) from the most recent 2 years (2013-2014) of NHANES and data from 21,013 participants in previous NHANES surveys from 2005 through 2012. For the years 2013-2014, the overall age-adjusted prevalence of obesity (body mass index [BMI] 30 or greater) was 38 percent; among men, it was 35 percent; and among women, it was 40 percent. The corresponding prevalence of class 3 (BMI 40 or greater) obesity overall was 7.7 percent; among men, it was 5.5 percent; and among women, it was 9.9 percent. Analyses of changes over the decade from 2005 through 2014, adjusted for age, race/Hispanic origin, smoking status, and education, showed significant increasing linear trends among women for overall obesity and for class 3 obesity but not among men.

Analyses of the data from 2013-2014 found that for men, obesity prevalence varied by smoking status, with the prevalence of obesity significantly lower among current smokers than among never smokers. For women, there were no significant differences by smoking status, but those with education beyond high school were significantly less likely to be obese.

The authors write that although there has been considerable speculation about the causes of the increases in obesity prevalence, data are lacking to show the causes of these trends, and there are few data to indicate reasons that these trends might accelerate, stop, or slow. “Other studies are needed to determine the reasons for these trends.”

(doi:10.1001/jama.2016.6458; this study is available pre-embargo at the For The Media website.)

Editor’s Note: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

Editorial: The Unrelenting Challenge of Obesity

“What is the next step in addressing the epidemic of obesity?” write Jody W. Zylke, M.D., Deputy Editor, JAMA, and Howard Bauchner, M.D., Editor in Chief, JAMA, in an editorial commenting on the two studies in this issue of JAMA examining trends of obesity in the U.S.

“Much research and attention have been directed toward treatment of obesity, but the development of new drugs and procedures will not solve the problem. Perhaps genetics will unlock some of the mysteries of obesity, but this will take time, and more immediate solutions are needed. The emphasis has to be on prevention, despite evidence that school- and community-based prevention programs and education campaigns by local governments and professional societies have not been highly successful.”

“The obesity epidemic in the United States is now 3 decades old, and huge investments have been made in research, clinical care, and development of various programs to counteract obesity. However, few data suggest the epidemic is diminishing. Perhaps it is time for an entirely different approach, one that emphasizes collaboration with the food and restaurant industries that are in part responsible for putting food on dinner tables.”

(doi:10.1001/jama.2016.6190; this editorial is available pre-embargo at the For The Media website.)

Editor’s Note: Please see the article for additional information, including financial disclosures, funding and support, etc.

Related Content: Recently published by JAMA, the Viewpoint “Lifespan Weighed Down by Diet,” by David S. Ludwig, M.D., Ph.D., of Boston Children’s Hospital and Harvard Medical School, Boston.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 7, 2016

Media Advisory: To contact Cynthia L. Ogden, Ph.D., call the NCHS Press Office at 301-458-4800 or email paoquery@cdc.gov.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.6361

Among U.S. children and adolescents 2 to 19 years of age, the prevalence of obesity in 2011- 2014 was 17 percent, and over approximately the last 25 years, the prevalence has decreased in children age 2 to 5 years, leveled off in children 6 to 11 years, and increased among adolescents 12 to 19 years of age, according to a study appearing in the June 7 issue of JAMA.

Previous analyses of obesity trends among children and adolescents showed an increase between 1988-1994 and 1999-2000, but no change between 2003-2004 and 2011-2012, except for a significant decline among children 2 to 5 years of age. Cynthia L. Ogden, Ph.D., of the National Center for Health Statistics, Centers for Disease Control and Prevention (CDC), Hyattsville, Md., and colleagues investigated trends in the prevalence of obesity and extreme obesity in children and adolescents age 2 to 19 years with measured weight and height in the 1988-1994 through 2013-2014 National Health and Nutrition Examination Surveys (NHANES). Obesity was defined as a body mass index (BMI) at or above the sex-specific 95th percentile on the CDC BMI-for-age growth charts; extreme obesity was defined as a BMI at or above 120 percent of the sex-specific 95th percentile on these charts.

Measurements from 40,780 children and adolescents (average age, 11 years; 49 percent female) between 1988-1994 and 2013-2014 were analyzed. Among children and adolescents 2 to 19 years of age, the prevalence of obesity in 2011-2014 was 17 percent and extreme obesity was 5.8 percent. Trends in child and adolescent obesity varied by age. During the approximately 25-year period, the prevalence increased until 2003-2004 but then decreased among children age 2 to 5 years (9.4 percent in 2013-2014). Among children 6 to 11 years of age, the prevalence increased until 2007-2008 and then leveled off (17.4 percent in 2013-2014). Among adolescents age 12 to 19 years, obesity prevalence increased between 1988-1994 (10.5 percent) and 2013-2014 (20.6 percent).

Trends in extreme obesity prevalence showed no change between 1988-1994 and 2013-2014 among children age 2 to 5 years, whereas it increased among children age 6 to 11 years (4.3 percent in 2013-2014) and among adolescents age 12 to 19 years (9.1 percent in 2013-2014).

No significant changes in either obesity or extreme obesity were seen between 2005-2006 and 2013-2014, suggesting any recent changes among adolescents were small.

(doi:10.1001/jama.2016.6361; this study is available pre-embargo at the For The Media website.)

Editor’s Note: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 7, 2016

Media Advisory: To contact the U.S. Preventive Services Task Force, email the Media Coordinator at Newsroom@USPSTF.net or call 202-572-2044.

To place an electronic embedded link to this study in your story  This link for the study will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.5824

The U.S. Preventive Services Task Force (USPSTF) has found convincing evidence that screening for syphilis infection in asymptomatic, nonpregnant persons at increased risk for infection provides substantial benefit. The report appears in the June 7 issue of JAMA.

This is an A recommendation, indicating that the USPSTF recommends the screening and that there is high certainty that the net benefit is substantial.

The number of cases of primary and secondary syphilis have been increasing since 2000. In 2014, approximately 20,000 cases of syphilis were reported in the United States. Left untreated, syphilis can progress to late-stage disease in about 15 percent of persons who are infected. Late-stage syphilis can lead to development of inflammatory lesions throughout the body, which can lead to cardiovascular or organ dysfunction. Syphilis infection also increases the risk for acquiring or transmitting human immunodeficiency virus (HIV) infection. To update its 2004 recommendation on screening for syphilis infection in nonpregnant adults, the USPSTF reviewed the evidence on screening for syphilis infection in asymptomatic, nonpregnant adults and adolescents, including patients coinfected with other sexually transmitted infections (such as HIV). Screening for syphilis in pregnant women was updated in a separate recommendation statement in 2009 (A recommendation).

The USPSTF is an independent, volunteer panel of experts that makes recommendations about the effectiveness of specific preventive care services such as screenings, counseling services, and preventive medications.

Risk Assessment

Men who have sex with men and persons living with HIV have the highest risk for syphilis infection. Other factors that are also associated with increased prevalence rates include a history of incarceration or commercial sex work, geography, race/ethnicity, and being a male younger than 29 years.

Detection

There are numerous screening tests for syphilis. Most common is a combination of nontreponemal and treponemal antibody tests. The USPSTF found convincing evidence that screening algorithms with high sensitivity and specificity are available to accurately detect syphilis.

Benefits of Early Detection and Treatment

The USPSTF found convincing evidence that treatment with antibiotics can lead to substantial health benefits in nonpregnant persons who are at increased risk for syphilis infection by curing syphilis infection, preventing manifestations of late-stage disease, and preventing sexual transmission to others.

Harms of Early Detection and Treatment

The USPSTF found no direct evidence on the harms of screening for syphilis in nonpregnant persons who are at increased risk for infection. Potential harms of screening include false-positive results that require clinical evaluation, unnecessary anxiety to the patient, and the potential stigma of having a sexually transmitted infection. The harms of antibiotic treatment are well established, and the magnitude of these harms is no greater than small.

Findings

The USPSTF concludes with high certainty that the net benefit of screening for syphilis infection in nonpregnant persons who are at increased risk for infection is substantial. Accurate screening tests are available to identify syphilis infection in populations at increased risk. Effective treatment with antibiotics can prevent progression to late-stage disease, with small associated harms, providing an overall substantial health benefit.

(doi:10.1001/jama.2016.5824; the full report is available pre-embargo to the media at the For the Media website)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Note: More information about the U.S. Preventive Services Task Force, its process, and its recommendations can be found on the newsroom page of its website.

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EMBARGOED FOR RELEASE: 4 P.M. (ET) THURSDAY, MAY 19, 2016

Media Advisory: To contact Jeffrey D. Williamson, M.D., M.H.S., call Marguerite Beck at 336-716-2415 or email marbeck@wakehealth.edu. To contact editorial author Aram V. Chobanian, M.D., email Gina DiGravio-Wilczewski at ginad@bu.edu.

To place an electronic embedded link to the study and editorial in your story  These links will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.7050; http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.7070

Among adults 75 years of age or older, treating to a systolic blood pressure target of less than 120 mm Hg compared with less than 140 mm Hg resulted in significantly lower rates of fatal and nonfatal major cardiovascular events and death from any cause, according to a study published online by JAMA. The study is being released to coincide with its presentation at the American Geriatrics Society Annual Scientific Meeting.

In the United States, 75 percent of persons older than 75 years have hypertension, for whom cardiovascular disease complications are a leading cause of disability, illness and death. The optimal systolic blood pressure (SBP) treatment target in geriatric populations with hypertension remains uncertain. Jeffrey D. Williamson, M.D., M.H.S., of the Wake Forest School of Medicine, Winston-Salem, N.C., and colleagues analyzed a subgroup (persons age 75 years or older with hypertension but without diabetes) in the Systolic Blood Pressure Intervention Trial (SPRINT) who were randomly assigned to an SBP target of less than 120 mm Hg (intensive treatment group, n = 1,317) or an SBP target of less than 140 mm Hg (standard treatment group, n = 1,319).

Among the participants (average age, 80 years; 38 percent women), 95 percent provided complete follow-up data. At a median follow-up of 3.1 years, there was a significantly lower rate of the primary composite outcome (nonfatal heart attack, acute coronary syndrome not resulting in a heart attack, nonfatal stroke, nonfatal acute decompensated heart failure, and death from cardiovascular causes; 102 events in the intensive treatment group vs 148 events in the standard treatment group). There was also a significantly lower rate of all-cause death (73 deaths vs 107 deaths, respectively).

Additional analysis suggested that the benefit of intensive BP control was consistent among persons in this age range who were frail or had reduced gait speed.

The overall rate of serious adverse events was not different between treatment groups.

“Considering the high prevalence of hypertension among older persons, patients and their physicians may be inclined to underestimate the burden of hypertension or the benefits of lowering BP, resulting in undertreatment. On average, the benefits that resulted from intensive therapy required treatment with 1 additional antihypertensive drug and additional early visits for dose titration and monitoring,” the authors write.

“Future analyses of SPRINT data may be helpful to better define the burden, costs, and benefits of intensive BP control. However, the present results have substantial implications for the future of intensive BP therapy in older adults because of this condition’s high prevalence, the high absolute risk for cardiovascular disease complications from elevated BP, and the devastating consequences of such events on the independent function of older people.”

(doi:10.1001/jama.2016.7050; this study is available pre-embargo at the For The Media website.)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Editorial: SPRINT Results in Older Patients – How Low to Go?

“Currently, more than 40 percent of persons with hypertension in the United States do not have their blood pressure controlled to levels less than 140/90 mm Hg, and if the goal SBP were reduced to less than 130 mm Hg, more than one-half of persons with hypertension would be considered to have uncontrolled blood pressure,” writes Aram V. Chobanian, M.D., of the Boston University School of Medicine, in an accompanying editorial.

“Achieving the SBP goal of less than 130 mm Hg may be challenging for clinicians, because doing so could require use of additional medications, more careful monitoring, and more frequent clinic visits. Nevertheless, the important results reported by Williamson et al in this issue of JAMA cannot be discounted, and unless unexpected adverse effects are observed on further examination of the trial data, then major changes in treatment goals for patients 75 years or older with hypertension will be warranted.”

(doi:10.1001/jama.2016.7070; this editorial is available pre-embargo at the For The Media website.)

Editor’s Note: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

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For more information: Contact JAMA Network Media Relations at 312-464-JAMA (5262) or email mediarelations@jamanetwork.org.

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EMBARGOED FOR RELEASE: 5:45 A.M. (ET) SUNDAY, MAY 22, 2016

Media Advisory: To contact Alexander Zarbock, M.D., email zarbock@uni-muenster.de.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.5828

In a study published online by JAMA, Alexander Zarbock, M.D., of University Hospital Munster, Germany, and colleagues examined whether early (compared with delayed) initiation of renal replacement therapy in patients who are critically ill with acute kidney injury reduces 90-day all-cause mortality. The study is being released to coincide with its presentation at the 53rd European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Congress.

Acute kidney injury (AKI) is a well-recognized complication of critical illness with a large effect on illness and death.  Despite increases in the knowledge of the management of patients who are critically ill, mortality associated with AKI remains high. The optimal timing of initiation of renal replacement therapy (RRT) in critically ill patients with AKI is still unknown. The researchers for this study randomly assigned 231 critically ill patients who had reached stage 2 AKI (per Kidney Disease: Improving Global Outcomes guidelines) and met other criteria, to early (within 8 hours of diagnosis of stage 2; n = 112) or delayed (within 12 hours of stage 3 AKI or no initiation; n = 119) initiation of RRT.

All patients in the early group and 108 of 119 patients (91 percent) in the delayed group received RRT. The researchers found that early initiation of RRT significantly reduced 90-day mortality compared with delayed initiation of RRT (39 percent vs 55 percent of patients died in each group, respectively).  More patients in the early group recovered renal function by day 90 (54 percent vs 39 percent). Duration of RRT (9 days vs 25 days) and length of hospital stay (51 days vs 82 days) were significantly shorter in the early group than in the delayed group. There was no significant effect on requirement of RRT after day 90, organ dysfunction, and length of ICU stay.

“Our study provides important feasibility data for an AKI stage-based, biomarker-guided interventional trial in AKI. However, an adequately powered multicenter trial is needed to confirm our results and establish the best time point for the initiation of RRT in critically ill patients with AKI,” the authors write.

(doi:10.1001/jama.2016.5828; this study is available pre-embargo at the For The Media website.)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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EMBARGOED FOR RELEASE: 9:45 A.M. (ET) TUESDAY, MAY 24, 2016

Media Advisory: To contact Gillian L. Booth, M.D., email Leslie Shepherd at ShepherdL@smh.ca. To contact editorial author Steven B. Heymsfield, M.D., email Alisha.prather@pbrc.edu or Stephanie.malin@pbrc.edu.

To place an electronic embedded link to this study and editorial in your story  These links will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.5898; http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.5635

Urban neighborhoods in Ontario, Canada, that were characterized by more walkable design were associated with decreased prevalence of overweight and obesity and decreased incidence of diabetes between 2001 and 2012, according to a study appearing in the May 24/31 issue of JAMA.

The global increase in obesity is a major health problem. One approach to reduce obesity through diet and exercise that is gaining interest among public health professionals and urban planners is to redesign the built environment to offer more opportunities for physical activity and healthy eating. Neighborhoods that favor pedestrian activities—those with high population density, high numbers of destinations within walking distance of residential areas, and well-connected streets—are characterized by higher rates of walking and bicycling for transportation and lower rates of car use.

Gillian L. Booth, M.D., of the Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto, and colleagues examined whether urban neighborhoods that are more walkable are associated with a slower increase in overweight, obesity, and diabetes than less walkable neighborhoods. The researchers used annual provincial health care (n = 3 million per year) and biennial Canadian Community Health Survey (n = 5,500 per cycle) data for adults (30-64 years) living in Southern Ontario cities. Neighborhood walkability was derived from a validated index, which included 4 equally weighted components: population density, residential density, walkable destinations (number of retail stores, services [e.g., libraries, banks, community centers], and schools within a 10-minute walk), and street connectivity. Neighborhoods were ranked and classified into quintiles from lowest (quintile 1) to highest (quintile 5) walkability.

There were 8,777 neighborhoods included in the study. In 2001, the adjusted prevalence of overweight and obesity was lower in quintile 5 vs quintile 1 (43 percent vs 54 percent). Between 2001 and 2012, the prevalence increased in less walkable neighborhoods, while the prevalence did not significantly change in areas of higher walkability. In 2001, the adjusted diabetes incidence was lower in quintile 5 than other quintiles and declined by 2012. In contrast, diabetes incidence did not change significantly in less walkable areas.

Rates of walking or cycling and public transit use were significantly higher, and that of car use lower in quintile 5 vs quintile 1 at each time point, although daily walking and cycling frequencies increased only modestly from 2001 to 2011 in highly walkable areas. Leisure-time physical activity, diet, and smoking patterns did not vary by walkability and were relatively stable over time.

The authors note that the “ecologic nature of these findings and the lack of evidence that more walkable urban neighborhood design was associated with increased physical activity suggest that further research is necessary to assess whether the observed associations are causal.”

(doi:10.1001/jama.2016.5898; this study is available pre-embargo at the For The Media website.)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Editorial: Can Walkable Urban Design Play a Role in Reducing the Incidence of Obesity-Related Conditions?

Andrew G. Rundle, Dr.P.H., of Columbia University, New York, and Steven B. Heymsfield, M.D., of the Pennington Biomedical Research Center, LSU System, Baton Rouge, comment on the findings of this study in an accompanying editorial.

“The findings of the study by Creatore et al reported in this issue of JAMA provide further large-scale and longitudinal support for the hypothesis that urban design choices promoting pedestrian activity are associated with greater engagement in active transport (walking and cycling), lower prevalence of overweight/obesity, and lower diabetes incidence at the population level. This study will make a prominent contribution to the research base that informs the urban design and health policy debates for years to come.”

(doi:10.1001/jama.2016.5635; this editorial is available pre-embargo at the For The Media website.)

Editor’s Note: Please see the article for additional information, including financial disclosures, funding and support, etc.

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EMBARGOED FOR RELEASE: 9:45 A.M. (ET) TUESDAY, MAY 24, 2016

Media Advisory: To contact Jenna Wong, M.Sc., email Cynthia Lee at cynthia.lee@mcgill.ca.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.3445

In a study appearing in the May 24/31 issue of JAMA, Jenna Wong, M.Sc., of McGill University, Montreal, Canada, and colleagues analyzed treatment indications for antidepressants and assessed trends in antidepressant prescribing for depression.

Antidepressant use in the United States has increased over the last 2 decades. A suspected reason for this trend is that primary care physicians are increasingly prescribing antidepressants for nondepressive indications, including unapproved (off-label) indications that have not been evaluated by regulatory agencies. For this study, the researchers used data from an electronic medical record and prescribing system that has been used by primary care physicians in community-based, fee-for-service practices around 2 major urban centers in Quebec, Canada. The study included prescriptions written for adults between January 2006 and September 2015 for all antidepressants except monoamine oxidase inhibitors. Physicians participating in the study had to document at least 1 treatment indication per prescription using a drop-down menu containing a list of indications or by typing the indication(s).

During the study period, 101,759 antidepressant prescriptions (6 percent of all prescriptions) were written by 158 physicians for 19,734 patients. Only 55 percent of antidepressant prescriptions were indicated for depression. Physicians also prescribed antidepressants for anxiety disorders (18.5 percent), insomnia (10 percent), pain (6 percent) and panic disorders (4 percent).  For 29 percent of all antidepressant prescriptions (66 percent of prescriptions not for depression), physicians prescribed a drug for an off-label indication, especially insomnia and pain. Physicians also prescribed antidepressants for several indications that were off-label for all antidepressants, including migraine, vasomotor symptoms of menopause, attention-deficit/hyperactivity disorder, and digestive system disorders.

“The findings indicate that the mere presence of an antidepressant prescription is a poor proxy for depression treatment, and they highlight the need to evaluate the evidence supporting off-label antidepressant use,” the authors write.

(doi:10.1001/jama.2016.3445; this study is available pre-embargo at the For The Media website.)

Editor’s Note: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

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EMBARGOED FOR RELEASE: 9:45 A.M. (ET) TUESDAY, MAY 24, 2016

Media Advisory: To contact Jiang He, M.D., Ph.D., email Keith Brannon at kbrannon@tulane.edu.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.4447

In a study appearing in the May 24/31 issue of JAMA, Jiang He, M.D., Ph.D., of the Tulane University School of Public Health and Tropical Medicine, New Orleans, and colleagues evaluated more than 3,500 participants with chronic kidney disease (CKD), examining the association between urinary sodium excretion and clinical cardiovascular disease (CVD) events. The study is being released to coincide with its presentation at the 53rd European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Congress.

Chronic kidney disease affects approximately 11 percent of the U.S. population and is associated with increased risk of CVD and all-cause mortality. Greater than 1 in 3 U.S. adults has CVD, and it is the leading cause of death in the United States. A positive association between sodium intake and blood pressure is well established. However, the association between sodium intake and clinical CVD remains less clear, and this relationship has not been investigated in patients with CKD.

This study included 3,757 patients with CKD from 7 locations in the U.S. enrolled in the Chronic Renal Insufficiency Cohort (CRIC) Study and were followed up from May 2003 to March 2013. Participants were requested to provide urine specimens at study entry and the first 2 annual follow-up visits. Among the participants (average age, 58 years; 45 percent women), 804 composite CVD events (congestive heart failure, stroke, or heart attack) occurred during a median 6.8 years of follow-up. The researchers found a significantly increased risk of CVD in individuals with the highest urinary sodium excretion independent of several important CVD risk factors, including use of antihypertensive medications and history of CVD. The cumulative incidence of CVD events in the highest quartile of calibrated sodium excretion compared with the lowest was 23.2 percent vs 13.3 percent for heart failure, 10.9 percent vs 7.8 percent for heart attack, and 6.4 percent vs 2.7 percent for stroke at median follow-up.

Findings were consistent across subgroups and independent of further adjustment for total caloric intake and systolic blood pressure.

“These findings, if confirmed by clinical trials, suggest that moderate sodium reduction among patients with CKD and high sodium intake may lower CVD risk,” the authors write.

(doi:10.1001/jama.2016.4447; this study is available pre-embargo at the For The Media website.)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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EMBARGOED FOR RELEASE: 12:00 P.M. (ET) SUNDAY, MAY 15, 2016

Media Advisory: To contact Hormuzd A. Katki, Ph.D., or Anil K. Chaturvedi, Ph.D., call the NCI Press Office at 301-496-6641 or email ncipressofficers@mail.nih.gov. To contact editorial author Michael K. Gould, M.D., M.S., email Sandra Hernandez-Millett at sandra.d.hernandez-millett@kp.org.
To place electronic embedded links to these papers in your story  These links will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.6255; http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.5986

Among a group of U.S. ever-smokers age 50 to 80 years, application of an individual-risk-based model for computed tomography (CT) screening for lung cancer compared with selecting risk-factor-based subgroups for screening (such as current U.S. Preventive Services Task Force recommendations) was estimated to be associated with a greater number of lung cancer deaths prevented over 5 years, according to a study published online by JAMA. The study is being released to coincide with its presentation at the American Thoracic Society International Conference.

Lung cancer is the most common cause of cancer death in the United States. The U.S. Preventive Services Task Force (USPSTF) recommends CT lung cancer screening for ever-smokers age 55 to 80 years who have smoked at least 30 pack-years with no more than 15 years since quitting. Selecting individuals at highest lung cancer risk, as determined by individual risk calculations (i.e., risk-based selection) rather than by risk factor-based subgroups, might lead to more efficient screening. Risk-based selection more precisely delineates the benefits and harms of screening by accommodating detailed information on all lung cancer risk factors.

Hormuzd A. Katki, Ph.D., and Anil K. Chaturvedi, Ph.D., of the National Cancer Institute, Bethesda, Md., and colleagues conducted a comparison of modeled outcomes from risk-based CT lung-screening strategies vs USPSTF recommendations. The study included empirical risk models for lung cancer incidence and death in the absence of CT screening using data on ever-smokers from the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO; 1993-2009) control group. Model validation in the chest radiography groups of the PLCO and the National Lung Screening Trial (NLST; 2002-2009), with additional validation of the death model in the National Health Interview Survey (NHIS; 1997-2001), a representative sample of the United States. Models were applied to U.S. ever-smokers age 50 to 80 years (NHIS 2010-2012) to estimate outcomes of risk-based selection for CT lung screening, assuming screening for all ever-smokers, and yield the percent changes in lung cancer detection and death observed in the NLST.

The researchers found that under USPSTF recommendations, the models estimated 9.0 million U.S. ever-smokers would qualify for lung cancer screening and 46,488 lung cancer deaths were estimated as screen-avertable over 5 years (estimated number needed to screen [NNS] to prevent 1 lung cancer death, 194). In contrast, risk-based selection screening of the same number of ever-smokers (9.0 million) at highest 5-year lung cancer risk was estimated to avert 20 percent more deaths (55,717) and was estimated to reduce the estimated NNS by 17 percent (NNS, 162).

“The key observation from the models is that compared with selecting risk-factor-based subgroups for screening (such as current USPSTF recommendations), individual-risk-based selection of smokers was estimated to prevent more deaths, improve screening effectiveness (defined as the NNS to prevent 1 lung cancer death), and improve screening efficiency (defined as the ratio of false-positive CT screening examinations to prevented deaths),” the authors write.

“Although CT screening can reduce lung cancer mortality by approximately 20 percent, the majority of lung cancer deaths are not screen-preventable at this time. The best way for smokers to avoid lung cancer, and all smoking-related illness, remains to quit smoking as early as possible.”

(doi:10.1001/jama.2016.6255; this study is available pre-embargo at the For The Media website.)

Editor’s Note: This study was supported by the Intramural Research Program of the U.S. National Institutes of Health/National Cancer Institute.  Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.

Editorial: Who Should Be Screened for Lung Cancer? And Who Gets to Decide?

“In clinical practice, the decision to screen is very personal and should be individualized for each patient,” writes Michael K. Gould, M.D., M.S., of Kaiser Permanente Southern California, Pasadena, in an accompanying editorial.

“Screening should be offered to high-risk patients who do not meet USPSTF or Medicare criteria so they can decide whether to undergo testing. By extension, a patient who meets USPSTF or Medicare criteria may reasonably decide that the risks of screening outweigh the benefits. The challenge for clinicians is to make sure that individual patients receive the information they need to make the best decision possible about whether screening is the right choice for them.”

(doi:10.1001/jama.2016.5986; this study is available pre-embargo at the For The Media website.)

Editor’s Note: Please see the article for additional information, including financial disclosures, funding and support, etc.

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EMBARGOED FOR RELEASE: 12:00 P.M. (ET) SUNDAY, MAY 15, 2016

Media Advisory: To contact Frank C. Sciurba, M.D., call Lawerence Synett at 412-647-9816 or email synettl@upmc.edu.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.6261

In a study published online by JAMA, Frank C. Sciurba, M.D., of the University of Pittsburgh, and colleagues assessed the 1-year effectiveness and safety of endobronchial coils on exercise tolerance, quality of life, and lung function in patients with severe emphysema. The study is being released to coincide with its presentation at the American Thoracic Society International Conference.

The endobronchial coils in this study were nitinol (a metal alloy) wires that were implanted in the lungs with an endoscope. The coils regain their preformed shape following deployment and restore elastic properties in lung tissue and improve ventilatory mechanical function. Patients with advanced emphysema and severe lung hyperinflation (an abnormal increase in lung capacity) have few treatment options to relieve dyspnea (shortness of breath).  Preliminary clinical trials have demonstrated that endobronchial coils may improve lung function, exercise tolerance, and symptoms in patients with emphysema and severe lung hyperinflation.

For this study, the researchers randomly assigned patients with severe emphysema to continue usual care alone (guideline based, including pulmonary rehabilitation and bronchodilators; n = 157) or usual care plus bilateral coil treatment (n = 158) involving 2 sequential procedures 4 months apart in which 10 to 14 coils were placed in a single lobe of each lung.

Among the study participants, 90 percent completed the 12-month follow-up. Median change in 6-minute walk distance (a measure of exercise tolerance) at 12 months was 10.3 m (33.8 feet) with coil treatment vs -7.6 m (24.9 feet) with usual care, with a between-group difference of 14.6 m (47.9 feet). Improvement of at least 25 m (82 feet) occurred in 40 percent of patients in the coil group vs 27 percent with usual care. Patients in the coil group also showed overall clinically important improvements in quality of life and greater improvement on a measure of lung function, although less than a clinically important difference.

Major complications (including pneumonia requiring hospitalization and other potentially life-threatening or fatal events) occurred in 35 percent of coil participants vs 19 percent of usual care. Other serious adverse events including pneumonia and pneumothorax (free air in the chest outside the lung) occurred more frequently in the coil group.

“Among patients with emphysema and severe hyperinflation treated for 12 months, the use of an endobronchial coil compared with usual care resulted in an improvement in median exercise tolerance that was modest and of uncertain clinical importance, with a higher likelihood of major complications. Further follow-up is needed to assess long-term effects on health outcomes,” the authors write.

(doi:10.1001/jama.2016.6261; this study is available pre-embargo at the For The Media website.)

Editor’s Note: This study was supported by PneumRx Inc., a BTG International group company. Drs. Sciurba, Criner, and Slebos receive institutional support from Pulmonx. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.

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EMBARGOED FOR RELEASE: 5:15 P.M. (ET) SUNDAY, MAY 15, 2016

Media Advisory: To contact Daryl J. Kor, M.D., M.Sc., call Sharon Theimer at 507-284-5005 or email newsbureau@mayo.edu.

To place an electronic embedded link to this study in your story This link will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.6330

In a study published online by JAMA, Daryl J. Kor, M.D., M.Sc., of the Mayo Clinic, Rochester, Minn., and colleagues evaluated the efficacy and safety of early aspirin administration for the prevention of acute respiratory distress syndrome (ARDS). The study is being released to coincide with its presentation at the American Thoracic Society International Conference.

Acute respiratory distress syndrome remains a life-threatening critical care syndrome. The median time to onset of ARDS is 2 days after hospital presentation. The period between hospital presentation and development of ARDS presents a brief window for possible prevention. ARDS is viewed as an inflammatory condition. Observational studies have suggested a potential preventive role for antiplatelet therapy in patients at high risk for ARDS.

Dr. Kor and colleagues randomly assigned patients at risk for ARDS (based on a lung injury prediction score) administration of aspirin (n = 195) or placebo (n = 195) within 24 hours of emergency department presentation and continued to hospital day 7, discharge, or death. The study was conducted at 16 U.S. academic hospitals.

The researchers found that the administration of aspirin, compared with placebo, did not significantly reduce the incidence of ARDS at 7 days (20 patients [10.3 percent] in the aspirin group vs 17 patients [8.7 percent] in the placebo group). No significant differences were seen in secondary outcomes or adverse events, such as ventilator-free days, hospital and intensive care unit length of stay, 28-day and 1-year survival.

“The findings of this phase 2b trial do not support continuation to a larger phase 3 trial,” the authors write.

(doi:10.1001/jama.2016.6330; this study is available pre-embargo at the For The Media website.)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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EMBARGOED FOR RELEASE: 5:15 P.M. (ET) SUNDAY, MAY 15, 2016

Media Advisory: To contact John P. Kress, M.D., email John Easton at John.Easton@uchospitals.edu. To contact editorial co-author Jeremy R. Beitler, M.D., M.P.H., email Michelle Brubaker at mmbrubaker@ucsd.edu.

To place electronic embedded links to these papers in your story  These links will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.6338; http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.5987

In a study published online by JAMA, Bhakti K. Patel, M.D., and John P. Kress, M.D., of the University of Chicago, and colleagues examined whether noninvasive ventilation delivered by helmet, compared with a face mask, improves intubation rate among patients with acute respiratory distress syndrome (ARDS). The study is being released to coincide with its presentation at the American Thoracic Society International Conference.

Noninvasive ventilation (NIV) with a face mask is relatively ineffective at preventing endotracheal intubation (placement of a tube into the windpipe [trachea] through the mouth or nose) in patients with ARDS. Complications of endotracheal intubation include pneumonia, excessive sedation and delirium. An alternative is to deliver NIV via a helmet interface—a transparent hood that covers the entire head of the patient with a soft collar neck seal. This interface offers several advantages over a face mask including improved tolerability and less air leak due to the helmet’s lack of contact with the face and improved seal integrity at the neck. This could reduce intubation rates and extend the benefits of NIV to more patients with ARDS.

Dr. Kress and colleagues randomly assigned patients with ARDS requiring NIV delivered by face mask for at least 8 hours while in the medical intensive care unit to continue face mask NIV or switch to a helmet for NIV support. The final analysis included 44 patients randomly assigned to the helmet group and 39 to the face mask group.

The intubation rate was 61.5 percent for the face mask group and 18.2 percent for the helmet group. The median number of ventilator-free days was significantly higher in the helmet group (28 vs 12.5). At 90 days, 15 patients (34 percent) in the helmet group died compared with 22 patients (56 percent) in the face mask group. Adverse events included 3 interface-related skin ulcers for each group.

“Multicenter studies are needed to replicate these findings,” the authors write.

(doi:10.1001/jama.2016.6338; this study is available pre-embargo at the For The Media website.)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Editorial: Unmasking a Role for Noninvasive Ventilation in Early Acute Respiratory Distress Syndrome

Several key clinical messages can be gained from this study, writes Jeremy R. Beitler, M.D., M.P.H., of the University of California, San Diego, and colleagues in an accompanying editorial.

“The helmet interface has unique advantages and disadvantages that may influence efficacy of NIV depending on patient and disease characteristics. External validation of the findings by Patel et al and clarification of appropriate eligibility criteria, optimal ventilator settings, and potential mechanisms of effect are needed before clinicians could consider an expanded role for helmet NIV in routine management of select patients with ARDS. Whether helmet NIV affords benefit over high-flow nasal cannula warrants testing in a multicenter trial. Regardless, it is increasingly clear that there may be an important albeit under-investigated role for some form of high-level noninvasive respiratory support to prevent intubation, and perhaps mortality, in acute hypoxemic respiratory failure.”

(doi:10.1001/jama.2016.5987; this study is available pre-embargo at the For The Media website.)

Editor’s Note: Please see the article for additional information, including other authors, financial disclosures, funding and support, etc.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, MAY 17, 2016

Media Advisory: To contact Douglas B. White, M.D., M.A.S., call Allison Hydzik at 412-647-9975 or email hydzikam@upmc.edu.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.5351

Among critically ill patients, expectations about prognosis often differ between physicians and surrogate decision makers, and the causes are more complicated than the surrogate simply misunderstanding the physicians’ assessments of prognosis, according to a study appearing in the May 17 issue of JAMA.

In 2010, it was estimated that nearly half of U.S. adults near the end of life were unable to make decisions for themselves about whether to accept life-prolonging technologies. Family members or other individuals are asked to serve as surrogate decision makers for these often difficult decisions. Douglas B. White, M.D., M.A.S., of the University of Pittsburgh Medical Center, Pittsburgh, and colleagues examined the prevalence of and factors related to physician-surrogate discordance about prognosis in intensive care units (ICUs). The study included surveys and qualitative interviews conducted in 4 ICUs at a major U.S. medical center involving surrogate decision makers and physicians caring for patients at high risk of death.

Two hundred twenty-nine surrogate decision makers and 99 physicians were involved in the care of 174 critically ill patients. Physician-surrogate discordance about prognosis (defined as a difference between a physician’s and a surrogate’s prognostic estimates of at least 20 percent) occurred in 122 of 229 instances (53 percent). In 65 instances (28 percent), discordance was related to both misunderstandings by surrogates and differences in belief about the patient’s prognosis; 17 percent were related to misunderstandings by surrogates only; 3 percent were related to differences in belief only; and data were missing for 12.

Seventy-five patients (43 percent) died. Surrogates’ prognostic estimates were much more accurate than chance alone, but physicians’ prognostic estimates were statistically significantly more accurate than surrogates’. Among 71 surrogates interviewed who had beliefs about the prognosis that were more optimistic than that of the physician, the most common reasons for optimism were a need to maintain hope to benefit the patient (n = 34), a belief that the patient had unique strengths unknown to the physician (n = 24), and religious belief (n = 19).

“There are at least 2 clinical implications of our findings. First, given the high rates of discordance about prognosis, clinicians communicating with surrogates of patients with advanced critical illness should routinely check in with surrogates about their perceptions of prognosis prior to engaging in decision making about goals of care,” the authors write.

“Second, when clinicians recognize that surrogates’ expectations about prognosis diverge from their own, they should explore the possibility that causes other than misunderstanding may be contributing, such as a belief that the patient is stronger than average, a belief that expressing optimism will improve the patient’s outcome, or a belief that religious rather than biomedical considerations will determine the patient’s outcome. This is important because interventions to reconcile discordance about prognosis may differ for misunderstandings compared with differences in belief.”

(doi:10.1001/jama.2016.5351; this study is available pre-embargo at the For The Media website.)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Note: Also available pre-embargo at the For The Media website is an accompanying editorial, “Communication With Family Caregivers in the Intensive Care Unit – Answers and Questions,” by Elie Azoulay, M.D., Ph.D., of Hopital Saint-Louis, Paris, and colleagues.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, MAY 17, 2016

Media Advisory: To contact Andrew M. Ibrahim, M.D., email Kara Gavin at kegavin@med.umich.edu.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.5618

In a study appearing in the May 17 issue of JAMA, Andrew M. Ibrahim, M.D., of the University of Michigan, Ann Arbor, and colleagues compared the surgical outcomes and associated Medicare payments at critical access hospitals vs non-critical access hospitals.

Critical access hospital designation was created to help ensure access to the more than 59 million people living in rural populations. Previous reports suggest these centers provide lower quality of care for common medical admissions. Little is known about the outcomes and costs of patients admitted for surgical procedures.

This study included a review of 1,631,904 Medicare beneficiary admissions to critical access hospitals (n = 828) and non-critical access hospitals (n = 3,676) for 1 of 4 common types of surgical procedures: appendectomy, gall bladder removal, removal of all or part of the colon, and hernia repair. The researchers compared risk-adjusted outcomes and adjusted for patient factors, admission type (elective, urgent, emergency), and type of operation.

Patients (average age, 77 years) undergoing surgery at critical access hospitals were less likely to have chronic medical problems, and they had lower rates of heart failure (7.7 percent vs 10.7 percent), diabetes (20 percent vs 22 percent), obesity (6.5 percent vs 10.6 percent), or multiple co-existing diseases (percent of patients with 2 or more comorbidities; 60 percent vs 70 percent). After adjustment for patient factors, critical access and non-critical access hospitals had no statistically significant differences in 30-day mortality rates (5.4 percent vs 5.6 percent).

Critical access vs non-critical access hospitals had significantly lower rates of serious complications (6 percent vs 14 percent). Medicare expenditures adjusted for patient factors and procedure type were lower at critical access hospitals than non-critical access hospitals ($14,450 vs $15,845).

“This study had 2 principal findings regarding how surgical care is delivered at critical access hospitals. First, the study found that performance of 4 common surgical procedures at critical access hospitals was associated with no difference in 30-day mortality and lower complication rates compared with non-critical access hospitals,” the authors write.

“Second, despite the reimbursement structure for critical access hospitals established in the Medicare Rural Hospital Flexibility Program, there was no evidence of higher expenditures for common surgical procedures. Both of these findings contrast previously published literature about nonsurgical admissions in these same settings and inform legislators about the valuable role critical access hospitals provide in the U.S. health care system.”

(doi:10.1001/jama.2016.5618; this study is available pre-embargo at the For The Media website.)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, MAY 17, 2016

Media Advisory: To contact Giancarlo Natalucci, M.D., email giancarlo.natalucci@usz.ch.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.5504

In a study appearing in the May 17 issue of JAMA, Giancarlo Natalucci, M.D., of the University of Zurich, Switzerland, and colleagues randomly assigned 448 preterm infants born between 26 weeks 0 days’ and 31 weeks 6 days’ gestation to receive either high-dose recombinant human erythropoietin (rhEPO) or placebo (saline) intravenously within 3 hours, at 12 to 18 hours, and at 36 to 42 hours after birth.

Although outcome in very preterm infants has improved in recent decades, they still experience significant long-term neurodevelopmental delay. Among several pharmacological candidates to prevent brain injury or improve development, EPO has been shown to be among the most promising. An association has been reported between early high-dose rhEPO and a reduced incidence of white and gray matter injuries assessed by cerebral magnetic resonance imaging in a group of very preterm infants.

Among the preterm infants in the study (average gestational age, 29 weeks; average birth weight, 1,210 g [2.7 lbs.]), 228 were randomly assigned to rhEPO and 220 to placebo. Neurodevelopmental outcome data were available for 365 (81 percent) at an average age of 23.6 months. The researchers found that cognitive development, as assessed with the Mental Development Index, was not significantly different between the rhEPO group and the placebo group. No differences were found between groups in secondary outcomes such as motor development, cerebral palsy, hearing or visual impairment, and anthropometric growth parameters.

“To the best of our knowledge, this study evaluated the largest population to date of very preterm infants treated with high-dose rhEPO during the first days of life. It is possible that rhEPO does not have a neuroprotective role,” the authors write.

“Follow-up for cognitive and physical problems that may not become evident until later in life is required.”

(doi:10.1001/jama.2016.5351; this study is available pre-embargo at the For The Media website.)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, MAY 17, 2016

Media Advisory: To contact Reshma Jagsi, M.D., D.Phil., email Nicole Fawcett at nfawcett@med.umich.edu.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.2188

In a study appearing in the May 17 issue of JAMA, Reshma Jagsi, M.D., D.Phil., of the University of Michigan, Ann Arbor, and colleagues conducted a survey of clinician-researchers on career and personal experiences, including questions on gender bias and sexual harassment.

In a 1995 survey, 52 percent of U.S. academic medical faculty women reported harassment in their careers compared with 5 percent of men. These women had begun their careers when women constituted a minority of the medical school class; less is known about the prevalence of such experiences among more recent faculty cohorts.

This study included 1,719 new recipients of career development awards (K-awards) from the National Institutes of Health in 2006-2009. The response rate to the survey was 62 percent (1,066 individuals). Average respondent age was 43 years; 46 percent were women; 71 percent were white. Women were more likely than men to report perceptions (70 percent vs 22 percent) and experience (66 percent vs 10 percent) of gender bias in their careers. Women were more likely to report having personally experienced sexual harassment (30 percent vs 4 percent). Among women reporting harassment (n = 150), 40 percent described more severe forms, 59 percent perceived a negative effect on confidence in themselves as professionals, and 47 percent reported that these experiences negatively affected their career advancement.

“Although a lower proportion reported these experiences [sexual harassment] than in a 1995 sample, the difference appears large given that the women began their careers after the proportion of female medical students exceeded 40 percent,” the authors write.

“Recognizing sexual harassment is important because perceptions that such experiences are rare may, ironically, increase stigmatization and discourage reporting. Efforts to mitigate the effect of unconscious bias in the workplace and eliminate more overtly inappropriate behaviors are needed.”

(doi:10.1001/jama.2016.2188; this study is available pre-embargo at the For The Media website.)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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