JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, MARCH 20, 2018

Media advisory: To contact corresponding author Nancy Baxter, M.D., Ph.D., email Leslie Shepherd at ShepherdL@smh.ca. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.21533

Bottom Line: A substantial amount of personal information, most of it personal health information, was found in the recycling at five hospitals in Toronto, Canada, despite policies in place for protection of personal information.

Why The Research Is Interesting: Patients have the right to expect safekeeping of personal information. With patient information increasingly maintained in the electronic health record, paper records are frequently discarded, creating risk for paper-based privacy breaches.

What and When: An audit of the amount and sensitivity of personally identifiable information (PII) and personal health information (PHI) found in recycling bins of five teaching hospitals in Toronto from November 2014 to May 2016. All hospitals had established PHI policies; for paper disposal, each hospital had recycling bins, garbage, and, for confidential information, secure shredding receptacles.

Authors: Nancy Baxter, M.D., Ph.D., University of Toronto, and coauthors

Results: Personally identifiable information and personal health information were found in recycling at all hospitals, including 2,687 documents with personally identifiable information. Most items were recovered at physician offices. Clinical notes, summaries and medical reports were the most frequent type of personally identifiable information inappropriately discarded.

Study Limitation: The study was restricted to recycling and did not include an examination of garbage disposal, which is another potential source of privacy breaches. The authors acknowledge that they are not aware of a case of inappropriate use or harm related to such privacy breaches.

Study Conclusions: Privacy breaches are commonly caused by human error so organizational solutions to improve the security of personal health information on paper are needed. Minimizing the printing of documents containing personal health information could help.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.21533)

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.

A summary video accompanies the JAMA article, “Weaving Indigenous Textile Art Into Cardiac Devices,” by Franz Freudenthal, M.D., of Kardiozentrum, La Paz, Bolivia, and coauthors and is available for download or to embed on your website. Download the video as a high-quality MP4 file by right-clicking on this link and then clicking the down-pointing arrow in the control bar at the bottom of the video. In addition, you may copy and paste the html code below to embed the video on your website.

<div style="display: block; position: relative; max-width: 300px;"><div style="padding-top: 50%;"><iframe src="//players.brightcove.net/864352215001/default_default/index.html?videoId=5721775868001" allowfullscreen webkitallowfullscreen mozallowfullscreen style="width: 100%; height: 100%; position: absolute; top: 0px; bottom: 0px; right: 0px; left: 0px;"></iframe></div></div>

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, MARCH 13, 2018

Media advisory: To contact corresponding author Christopher J. L. Murray, M.D., D.Phil., email Kelly Bienhoff at kbien@uw.edu. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2018.0900

Bottom Line: Deaths from alcohol and drug use disorders, self-harm and interpersonal violence varied widely among U.S counties.

Why The Research Is Interesting: Substance use disorders and intentional injuries are causes of premature death and disability in the United States. Understanding how mortality rates vary at a local level is important for developing effective public health and policy responses.

Who and When: About 2.8 million deaths between 1980 and 2014 in the United States due to substance use disorders (alcohol and drug) and intentional injuries (self-harm and interpersonal violence)

What (Study Measures): County of residence (exposure); mortality rates by U.S. county from 3,110 counties due to alcohol and drug use disorders, self-harm and interpersonal violence (outcomes)

Authors: Christopher J. L. Murray, M.D., D.Phil., Institute for Health Metrics and Evaluation, University of Washington, Seattle, and coauthors

Results: 

Study Limitation: Data are subject to error.

Study Conclusions: These findings may help inform efforts at prevention, diagnosis and treatment to improve health and reduce inequalities.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2018.0900)

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.

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, MARCH 13, 2018

Media advisory: To contact corresponding author Irene Papanicolas, Ph.D., email i.n.papanicolas@lse.ac.uk; to contact co-author Ashish K. Jha, M.D., M.P.H., email Todd Datz at tdatz@hsph.harvard.edu. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2018.1150

Bottom Line: The United States spent nearly twice as much as other high-income countries on medical care but did less well on many population health outcomes despite similar utilization.  Spending differences were driven primarily by prices for labor and goods, including pharmaceuticals, devices and administrative costs.

Why The Research Is Interesting: It is well known that the United States spends more on health care than other countries but less is understood about what explains those differences.

What and When: Analysis of data from 2013-2016 comparing differences in health care spending, performance and structural features between the United States and 10 high-income countries (United Kingdom, Canada, Germany, Australia, Japan, Sweden, France, the Netherlands, Switzerland, and Denmark).

Authors: Irene Papanicolas, Ph.D., Harvard T.H.Chan School of Public Health, Boston and coauthors

Results

The United States:

— Spent 17.8% of its gross domestic product on health in 2016, other countries ranged from 9.6% to 12.4%

— Had the lowest life expectancy and highest infant mortality rate

— Spent more to plan, regulate and manage health systems and services

— Had higher per capita pharmaceutical costs

— Paid higher salaries to physicians and nurses

Study Limitations: While the data were generally comparable, there were modest differences in approaches to collecting and standardizing data across countries.

Study Conclusions: Efforts targeting health care usage alone are unlikely to reduce growth in health care spending in the United States, and a more concerted effort to reduce prices and administrative costs is likely needed.

Featured Image:

What The Image Shows: The difference between the U.S. and other high-income countries in health spending as a percentage of gross domestic product. (Click on the image for a full-size version. Right click to “save image as” to download.)

Related material: The following related elements also are available on the For The Media website:

— A summary video is available for download or to embed on your website. Download the video as a high-quality MP4 file by right-clicking on this link and then clicking the down-pointing arrow in the control bar at the bottom of the video. In addition, you may copy and paste the html code below to embed the video on your website.

<div style="display: block; position: relative; max-width: 300px;"><div style="padding-top: 50%;"><iframe src="//players.brightcove.net/864352215001/default_default/index.html?videoId=5737884641001" allowfullscreen webkitallowfullscreen mozallowfullscreen style="width: 100%; height: 100%; position: absolute; top: 0px; bottom: 0px; right: 0px; left: 0px;"></iframe></div></div>

— An audio author interview is available on this page. You can download the transcript here.

The following editorials and Viewpoint:

— The Real Cost of the U.S. Health Care System

— Challenges in Understanding Differences in Health Care Spending Between the United States and Other High-Income Countries

— Factors Contributing to Higher Health Care Spending in the United States Compared With Other High-Income Countries

— Health Care Spending in the United States Compared With 10 Other High-Income Countries

— Hip and Knee Replacements (Viewpoint)

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2018.1150)

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.

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, MARCH 6, 2018

Media advisory: To contact corresponding author Richard M. Martin, Ph.D., email Stephanie McClellan at stephanie.mcclellan@cancer.org.uk or call +44 (0)20 3469 5314. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2018.0154

Bottom Line: A screening program that invited men to a clinic to undergo a single prostate-specific antigen (PSA) test increased detection of low-risk prostate cancer but made no significant difference in prostate cancer deaths after 10 years.

Why The Research Is Interesting: Prostate cancer screening remains controversial because potential benefits may be outweighed by harms from overdetection and overtreatment. Current policy in the United Kingdom, where this clinical trial was conducted, doesn’t advocate screening.

Who and When: 419,582 men from 573 primary care practices in the United Kingdom; recruitment started in 2001 and patient follow-up ended in March 2016

Interventions and Measures: 189,386 men at 271 practices were invited to attend a PSA testing clinic and to receive a single PSA test while 219,439 men at 302 practices were unscreened in a control group for comparison (intervention); death from prostate cancer after about 10 years and secondary outcomes including cancer stage at diagnosis (outcomes)

How (Study Design): This was a randomized clinical trial. RCTs allow for the strongest inferences to be made about the true effect of an intervention. However, not all RCT results can be replicated in real-world settings because patient characteristics or other variables may differ from those that were studied in the RCT.

Authors: Richard M. Martin, Ph.D., University of Bristol, England, and coauthors

Results:

Study Limitations: A single PSA screening may fail to reflect a long-term effect of multiple PSA testing rounds; a follow-up of 10 years may be too short to identify the effect of screening.

Study Conclusions: The findings don’t support single PSA testing for population-based screening.

Related material: The editorial, “Screening for Prostate Cancer”, by Michael J. Barry, M.D., Harvard Medical School, Boston, and the study, “Radical Prostatectomy, External Beam Radiotherapy, or External Beam Radiotherapy With Brachytherapy Boost and Disease Progression and Mortality in Patients With Gleason Score 9-10 Prostate Cancer,” by Amar U. Kishan, M.D., University of California, Los Angeles, and coauthors, also are available on the For The Media website.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2018.0154)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, MARCH 6, 2018

Media advisory: To contact corresponding author Erin E. Krebs, M.D., M.P.H., email Ralph Heussner at Ralph.Heussner@va.gov. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2018.0899

Bottom Line: Opioid medications were not better at improving pain that interfered with activities such as walking, work and sleep over 12 months for patients with chronic back pain or hip or knee osteoarthritis pain compared to nonopioid medications.

Why The Research Is Interesting: There is limited evidence regarding long-term outcomes for treatment of chronic pain with opioids compared with nonopioid medications.

Who and When: 240 patients from Veterans Affairs clinics with moderate to severe chronic back pain or hip or knee osteoarthritis pain; patients entered the study from 2013 to 2015 and follow-up ended in 2016

What (Study Measures): Patients were treated with opioid or nonopioid medications (interventions); pain-related function (how much pain interfered with activities such as walking, work and sleep) over 12 months; pain intensity and medication-related symptoms (outcomes)

How (Study Design): This was a randomized clinical trial (RCT). RCTs allow for the strongest inferences to be made about the true effect of an intervention. However, not all RCT results can be replicated in real-world settings because patient characteristics or other variables may differ from those that were studied in the RCT.

Authors: Erin E. Krebs, M.D., M.P.H., Minneapolis Veterans Affairs Health Care System, Minneapolis, and coauthors

Results:

In other outcomes, pain intensity was less intense in the nonopioid group and adverse medication-related symptoms were more common in the opioid group.

Study Limitation: Because this study was conducted in Veterans Affairs clinics, patient characteristics differ from those of the general population.

Study Conclusions: The results don’t support the initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2018.0899)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, FEBRUARY 27, 2018

Media advisory: To contact corresponding author Aaron A. R. Tobian, M.D., Ph.D., email Chanapa Tantibanchachai at chanapa@jhmi.edu. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.20121

Bottom Line: The frequency of red blood cell and plasma transfusions decreased among hospitalized patients in the United States from 2011 to 2014.

Why The Research Is Interesting: Blood transfusions are one of the most common hospital procedures. Hospitals have implemented blood management programs with restrictive transfusion practices that are aimed at improving patient outcomes, reducing costs and conserving blood.

What and When: An examination of 20 percent of all U.S. hospital inpatient discharges from 1993 to 2014 to examine trends in transfusions of red blood cells, plasma and platelets

How (Study Design): This is a population epidemiology study. A population epidemiology study describes characteristics of one or more large populations, typically without detailed information about underlying causes.

Authors: Aaron A. R. Tobian, M.D., Ph.D., Johns Hopkins University, Baltimore, and coauthors

Results: There was a decrease in red blood cell and plasma transfusions from 2011 to 2014; platelet transfusions remained stable.

Study Limitations: The diagnostic coding used for this study was carried out primarily for billing purposes and it was not possible to verify its accuracy. The study also was limited to inpatient transfusions, so the results may not be generalizable to outpatient transfusions.

Study Conclusions: Observed decreases in red blood cell and plasma transfusions may demonstrate the safety of restricting red blood cell transfusions, blood management programs and blood conservation initiatives.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.20121)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, FEBRUARY 27, 2018

Media advisory: To contact corresponding author Pei-Chun Chen, Ph.D., email ellis@cgmh.org.tw. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2018.0246

Bottom Line: Varicose veins were associated with increased risk of developing a type of blood clot known as a deep venous thrombosis (DVT), although more research is needed to understand the strength of that association.

Why The Research Is Interesting: Varicose veins are common, with about 23 percent of U.S. adults having the condition, but they are rarely associated with serious health risks. Not much is known about varicose veins and the risk of other vascular diseases including DVT, pulmonary embolism (PE) and peripheral artery disease (PAD).

Who and When: 212,984 patients with varicose veins and 212,984 without varicose veins from claims data in Taiwan’s National Health Insurance program; patients were enrolled from 2001 to 2013 and followed up through 2014

What (Study Measures): Varicose veins (exposure); risk of developing DVT, PE and PAD in people with and without varicose veins (outcomes)

How (Study Design): This was an observational study. Researchers were not intervening for purposes of the study and cannot control all the natural differences that could explain study findings.

Authors: Pei-Chun Chen, Ph.D., China Medical University, Taichung, Taiwan, and coauthors

Results: Varicose veins were associated with increased risk of DVT but more research is needed to understand whether that association is causal or if it reflects a common set of risk factors. Findings about potential associations between varicose veins and risk of PE and PAD were less clear because of possible confounding factors.

Study Limitations: Claims data do not include information for patients who do not seek medical care; study results may reflect only the risk among patients with more severe varicose veins requiring medical treatment.

Study Conclusions:

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2018.0246)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, FEBRUARY 20, 2018

Media advisory: To contact corresponding author Christopher D. Gardner, Ph.D., email Hanae Armitage at harmitag@stanford.edu. The full study is available on the For The Media website.

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Bottom Line: Weight loss over a year was not significantly different for overweight adults who followed a low-fat or low-carbohydrate diet, and neither a person’s genetic makeup nor their insulin secretion level was associated with how much weight they lost.

Why The Research Is Interesting: No one diet strategy is consistently better than others for weight loss in the general population. Some studies have suggested variations in people’s genetic makeup could make it easier for some to lose weight than others on certain diets. Other studies have reported a person’s insulin secretion may explain different weight loss.

Who and When: 609 overweight adults enrolled in a randomized clinical trial from January 2013 through April 2015 with follow-up through May 2016.

What (Study Intervention): Adults followed either a healthy low-fat or healthy low-carbohydrate diet (interventions); weight change at 12 months and a determination about whether there were significant links between the type of diet and a person’s genetic makeup, insulin secretion levels and weight loss (outcomes)

How (Study Design): This was a randomized clinical trial (RCT), which allows the strongest inferences to be made about the true effect of an intervention. However, not all RCT results can be replicated in real-world settings because patient characteristics or other variables may differ from those studied in the RCT.

Authors: Christopher D. Gardner, Ph.D., Stanford University Medical School, Stanford, California, and coauthors

Results:

A person’s genetic makeup or insulin secretion level at the start of the study was not associated with effects on weight loss.

Study Limitation: The generalizability of the findings may be limited because the study was conducted in a geographic area where many people have attained relatively high education levels and/or have the personal resources to allow them high accessibility to high-quality food options.

Study Conclusions:

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2018.0245)

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

#  #  #

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

JAMA

FOR IMMEDIATE RELEASE: WEDNESDAY, FEBRUARY 14, 2018

Media advisory: To contact authors Randel L. Swanson, II, D.O., Ph.D. and Douglas H. Smith, M.D., email Holly Auer at Holly.Auer@uphs.upenn.edu.

The full study is available on the JAMA website and the following link can be embedded in your story: https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2018.1742

Bottom Line: Concussion-like symptoms were observed in U.S. government personnel in Cuba after they reported hearing intensely loud sounds in their homes and hotel rooms and feeling changes in air pressure caused by an unknown source. The symptoms were consistent with brain injury although there was no history of head trauma.

Why The Research Is Interesting: In late 2016, U.S. government personnel in Havana, Cuba, visited the embassy medical unit after experiencing unusual sound and sensory phenomena and the onset of neurological symptoms. The U.S. Department of State convened an expert panel in July 2017, which came to a consensus that the initial findings were most likely related to neurotrauma from a non-natural source and the department recommended further investigation of the symptoms. The University of Pennsylvania’s Center for Brain Injury and Repair was selected to coordinate the evaluation, treatment and rehabilitation of these patients. This article in JAMA reports the preliminary findings.

Who and When: 21 government personnel (11 women and 10 men) identified by the State Department and evaluated an average of 203 days following exposure to reported sound (described as “buzzing,” “grinding  metal,” “piercing squeals” or “humming”) and sensory phenomena (described as pressure-like or vibrating and likened to air “baffling” inside a moving car with the windows partially rolled down)

What (Study Measures): Audible and sensory phenomena coming from a distinct direction but from an unknown source (exposure); descriptions of symptoms and personnel experience with rehabilitation and return to work (outcomes)

How (Study Design): This was a case series, which describes the clinical course or outcomes of a group of patients. Researchers cannot control for exposures or differences that could explain patient outcomes and they cannot prove a causal relationship.

Authors: Randel L. Swanson, II, D.O., Ph.D., and Douglas H. Smith, M.D., of the University of Pennsylvania, Philadelphia, and coauthors

Results: 

Study Limitations: To protect patient privacy, certain details typically reported in a case series were omitted, including specifics about geography, the relationship between individuals and individual demographics.

Study Conclusions: The unique circumstances of these patients and the clinical manifestations detailed in this report raise concern about a new mechanism for possible acquired brain injury from an exposure of unknown origin.

Related material:

• The accompanying editorial, “Neurological Symptoms Among U.S. Diplomats in Cuba,” by Christopher C. Muth, M.D., a JAMA associate editor, and Steven L. Lewis, M.D., of the Lehigh Valley Health Network, Allentown, Pennsylvania, offers this caution:

• Listen to an interview with authors from the University of Pennsylvania, Philadelphia, here. Download a transcript here.

• A JAMA Medical News & Perspectives article, “More Questions Raised by Concussion-Like Symptoms Found in U.S Diplomats Who Served in Havana” by Rita Rubin.

For more details and to read the full study, please visit the JAMA website.

(doi:10.1001/jama.2018.1742)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, FEBRUARY 13, 2018

Media advisory: To contact corresponding author Jamie R. Daw, M.Sc., email Todd Datz at tdatz@hsph.harvard.edu. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2018.0030

Bottom Line: The dependent coverage provision of the Affordable Care Act (ACA) that allowed young adults to stay on their parents’ insurance until they were 26 was associated with increased use of prenatal care, increased private insurance payment for births, and a modest reduction in preterm births.

Why The Research Is Interesting: Nearly one-third of U.S. births are to women in the age range of the ACA dependent coverage provision (19-25 years). The effect of this provision on pregnancy-related health care and health outcomes had not been known.

Who and When: Nearly 3 million births among women ages 24 to 25 (exposure group within the age range of the ACA provision) and women ages 27 to 28 (older control group outside the provision’s age range) before (in 2009) and after enactment of the ACA dependent coverage provision (2011-2013)

What (Study Measures): Dependent coverage provision of the ACA (exposure); payment source for births, early and adequate prenatal care (outcomes).

How (Study Design): This was an observational study. Researchers were not intervening for purposes of the study and cannot control all the natural differences that could explain the study findings.

Authors: Jamie R. Daw, M.Sc., Harvard Medical School, and Benjamin D. Sommers, M.D., Ph.D., Harvard T. H. Chan School of Public Health, Boston

Results:

Study Limitations: The dependent coverage provision may have had a different effect on women younger than those included in this analysis, among whom rates of prenatal care are typically lower and risk of adverse birth outcomes are higher.

Conclusions: The ACA’s dependent coverage provision is one of many components of the law with the potential to affect reproductive-age and pregnant women. Further research should focus on other aspects of the law on insurance coverage during pregnancy and the effects on access to care, maternal outcomes and children’s health outcomes.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2018.0030)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, FEBRUARY 13, 2018

Media advisory: To contact the U.S. Preventive Services Task Force, email the Media Coordinator at Newsroom@USPSTF.net or call 202-572-2044. The full report is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.21926

Bottom Line: The U.S. Preventive Services Task Force (USPSTF) recommends against screening for ovarian cancer in women without symptoms and who are not known to be at high risk (such as those who have certain hereditary cancer syndromes that increase the risk for ovarian cancer).

Background: The USPSTF routinely makes recommendations about the effectiveness of preventive care services. This latest recommendation statement on screening for ovarian cancer is an update from 2012. Ovarian cancer is the fifth most common cause of cancer death among U.S. women, with approximately 14,000 deaths per year.

How: The USPSTF recommendation statement follows a review of evidence on the benefits and harms of screening for ovarian cancer in asymptomatic women not known to be at high risk for ovarian cancer.

Related material

The following related elements from The JAMA Network are also available on the For The Media website:

Screening for Ovarian Cancer – Updated Evidence Report and Systematic Review for the US Preventive Services Task Force

— JAMA editorial: Screening for Ovarian Cancer in Asymptomatic Women

— JAMA Oncology editorial: The Yet Unrealized Promise of Ovarian Cancer Screening

— JAMA Internal Medicine editorial: Is There a Future for Ovarian Cancer Screening?

— JAMA Patient Page: Screening for Ovarian Cancer

Previously published by JAMA, The Hunt Continues for Early Ovarian Cancer Clues; Evolving Approaches in Research and Care for Ovarian Cancers.

For more details and to read the full report, please visit the For The Media website.

(doi:10.1001/jama.2017.21926)

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.

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, FEBRUARY 6, 2018

Media advisory: To contact corresponding author Christina D. Chambers, Ph.D., M.P.H., email Michelle Brubaker at mmbrubaker@ucsd.edu. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.21896

Bottom Line: Children whose mothers drank alcohol during pregnancy can have fetal alcohol spectrum disorders, and the frequency of these disorders, which can cause developmental disabilities, may be higher than previously estimated.

Why The Research Is Interesting: Older data suggest the estimated frequency of fetal alcohol spectrum disorders in the United States is 10 per 1,000 children.

Who and When: 6,639 children were selected from among 13,146 first-graders in four regions of the United States and assessed for fetal alcohol spectrum disorders from 2010-2016

What (Study Measures): Maternal alcohol consumption during pregnancy (exposure); frequency of fetal alcohol spectrum disorders in children (outcomes)

How (Study Design): This was an observational study. Researchers were not intervening for purposes of the study and cannot control all the natural differences that could explain the study findings.

Authors: Christina D. Chambers, Ph.D., M.P.H., University of California San Diego School of Medicine, and coauthors

Results: Estimates of the frequency of fetal alcohol spectrum disorders ranged from 11.3 to 50 per 1,000 children.

Study Limitations: Children were from four geographic regions (Rocky Mountain, Midwest, Southeast and Pacific Southwest) and those regions may not be representative of the United States overall.

Study Conclusions: Estimated frequency of fetal alcohol spectrum disorders among first-graders in four U.S. communities ranged from 1.1 percent to 5 percent. These findings may represent more accurate U.S. prevalence estimates than previous studies but may not be generalizable to all communities.

Related material: The following related elements also are available on the For The Media website:

— The editorial, “Implications of Higher Than Expected Prevalence of Fetal Alcohol Spectrum Disorders,” by Shannon Lange, M.P.H., Centre for Addiction and Mental Health, Toronto, and coauthors.

— Previously published by JAMA Pediatrics, Global Prevalence of Fetal Alcohol Spectrum Disorder Among Children and Youth.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.21896)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), THURSDAY, FEBRUARY 1, 2018

Media advisory: To contact corresponding author Atheendar S. Venkataramani, M.D., Ph.D., email Katie Delach at Katharine.Delach@uphs.upenn.edu. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2018.0140

Video: A summary video is available for download or to embed on your website. Additional information is available below.

Bottom Line: Career players in the National Football League (NFL) had slightly higher rates of death that were not statistically different from those of replacement players who made only a few appearances during a short league strike in the 1980s.

Why The Research Is Interesting: Playing football may be potentially harmful for several reasons, including repeated head trauma that may result in chronic traumatic encephalopathy (CTE), a degenerative brain disease. Previous studies examining the rate of death in retired NFL players have been limited by comparisons with the general population because a better comparison group would be individuals with similar athletic attributes and lifestyles.

Who and When: 3,812 retired players who started in the NFL from 1982 to 1992, including 2,933 regular NFL players and 897 replacement players hired temporarily to play during a three-game strike in 1987

What (Study Measures): Participation in the NFL as a career or replacement player (exposures); death from any cause by December 31, 2016 (outcome)

How (Study Design): This was an observational study. Researchers were not intervening for purposes of the study and cannot control all the natural differences that could explain the study findings.

Authors: Atheendar S. Venkataramani, M.D., Ph.D., Perelman School of Medicine, University of Pennsylvania, Philadelphia and coauthors

Results: A slightly higher, but not statistically significant, difference in long-term risk of death was associated with a playing career in the NFL compared with a short stint as a replacement player during a league strike. Seven career players died of amyotrophic lateral sclerosis (ALS) compared to no replacement players.

Study Limitations: Estimates were based on a small number of deaths so the analysis may not detect meaningful associations; additional analyses with longer-term follow-up may be helpful.

Study Conclusions:

Related material: The following related elements also are available on the For The Media website:

• A summary video is available for download or to embed on your website. Download the video as a high-quality MP4 file by right-clicking on this link and then clicking the down-pointing arrow in the control bar at the bottom of the video. In addition, you may copy and paste the html code below to embed the video on your website.

<div style="display: block; position: relative; max-width: 300px;"><div style="padding-top: 50%;"><iframe src="//players.brightcove.net/864352215001/default_default/index.html?videoId=5720358556001" allowfullscreen webkitallowfullscreen mozallowfullscreen style="width: 100%; height: 100%; position: absolute; top: 0px; bottom: 0px; right: 0px; left: 0px;"></iframe></div></div>

• The editorial, “Long-Term Mortality in NFL Professional Football Players: No Significant Increase But Questions Remain,” by Steven T. DeKosky, M.D., of the University of Florida College of Medicine, Gainesville, and coauthors
• The Patient Page, “Sport-Related Concussion”
• Previously published articles by JAMA that also may be of interest: Clinicopathological Evaluation of Chronic Traumatic Encephalopathy in Players of American Football and Advances and Gaps in Understanding Chronic Traumatic Encephalopathy

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2018.0140)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, JANUARY 23, 2018

Media advisory: To contact corresponding author Mahmoud Zureik, M.D., Ph.D., email mahmoud.zureik@ansm.sante.fr. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.21269

Bottom Line: Hysteroscopic sterilization, a non-surgical procedure that involves placing small implants in the fallopian tubes to make a woman infertile, was associated with an increased risk of gynecological complications (most notably sterilization failure with subsequent pregnancy) compared to surgical sterilization, but there were no differences between the two approaches in medical outcomes.

Why The Research Is Interesting: In developed countries, two main types of female sterilization are available: hysteroscopic and laparoscopic, the latter involving general anesthesia and a small incision in the abdominal wall. Safety concerns related to hysteroscopic sterilization were raised in the United States in 2015 by women who reported to the U.S. Food and Drug Administration (FDA) large numbers of adverse events, including bleeding, unwanted pregnancy, abdominal pain, depression, and thyroid disorders.

Who and When: 105,357 women in France who underwent hysteroscopic sterilization or laparoscopic sterilization between 2010-2014 and followed up through December 2015.

What (Study Measures): Hysteroscopic sterilization or laparoscopic sterilization (exposures); risks of procedural complications (surgical and medical), gynecological complications (sterilization failure that includes second sterilization procedure or pregnancy) and medical outcomes (including all types of allergy; autoimmune diseases; thyroid disorder; use of analgesics, antimigraines, antidepressants, outpatient visits; sickness absence; suicide attempts; death) that occurred within one and three years after sterilization (outcomes)

How (Study Design): This is an observational study. Because researchers are not intervening for purposes of the study they cannot control natural differences that could explain the study findings.

Authors: Mahmoud Zureik, M.D., Ph.D., French National Agency for Medicines and Health Products Safety, Saint-Denis, France and coauthors

Results: Hysteroscopic sterilization was associated with a lower immediate risk of procedural complications and a higher risk of gynecological complications, but not associated with an increased risk of certain medical outcomes.

Study Limitations: Administrative databases were used to investigate a possible role of hysteroscopic sterilization in notified complaints. All individual disorders reported by patients or physicians and collected into medical device vigilance databases could not be examined.

Study Conclusions:

Related material:

The following related elements also are available on the For The Media website:

• The editorial, “Evaluating the Long-term Safety of Hysteroscopic Sterilization,” by Eve Espey, M.D., M.P.H., and Lisa G. Hofler, M.D., M.P.H., M.B.A., University of New Mexico, Albuquerque.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.21269)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, JANUARY 16, 2018

Media advisory: To contact corresponding author Orna Reges, Ph.D., email ornare@clalit.org.il. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.20513

Bottom Line: Obese patients who underwent weight-loss surgery had a lower rate of death from any cause compared with obese adults who received nonsurgical care to manage their obesity.

Why The Research Is Interesting: Much is known about the short-term outcomes of bariatric surgery for weight loss but relatively little is known about its long-term effects. Some previous research has been limited by a number of factors, including the lack of a comparison group of obese patients who did not undergo bariatric surgery.

Who and When: 8,385 obese patients in Israel who underwent bariatric surgery (laparoscopic banding, Roux-en-Y gastric bypass, or laparoscopic sleeve gastrectomy) from 2005-2014; 25,155 obese patients who received nonsurgical care for obesity management from primary care physicians that may have included dietary counseling and behavior modification.

What (Study Measures): Bariatric surgery (exposure); death from any cause (outcome)

How (Study Design): This is a retrospective cohort study that used data from the past to compare obese patients who had bariatric surgery with those who didn’t and death from any cause. The study is observational. Because researchers are not intervening for purposes of the study they cannot control for all the natural differences that could explain study findings.

Authors: Orna Reges, Ph.D., Clalit Health Services, Tel Aviv, Israel and coauthors

Results: The rate of death from any cause over about 4.5 years was lower among obese patients who underwent bariatric surgery compared with patients who managed their obesity with nonsurgical care.

Study Limitations: Imbalances caused by matching groups of obese patients for comparison based on age, sex, body mass index and diagnoses of diabetes.

Study Conclusions: The association between bariatric surgery and a lower rate of death from any cause adds to the limited literature describing the beneficial outcomes of these surgical procedures for obese patients.

Related material:

The following related elements from this issue of JAMA are also available on the For The Media website:

— Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity

— Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity

— Lifestyle Intervention and Medical Management With vs Without Roux-en-Y Gastric Bypass and Control of Hemoglobin A_1c, LDL Cholesterol, and Systolic Blood Pressure at 5 Years in the Diabetes Surgery Study

— Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities

— Editorial: Comparing the Outcomes of Sleeve Gastrectomy and Roux-en-Y Gastric Bypass for Severe Obesity

— Editorial: Reimagining Obesity in 2018 – A JAMA Theme Issue on Obesity

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.20513)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, JANUARY 16, 2018

Media advisory: To contact corresponding author Charles Billington, M.D., email Naomi McDonald at naomim@umn.edu. The full study is available on the For The Media website.

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Bottom Line: Obese adults with type 2 diabetes who underwent gastric bypass surgery continued to improve after five years at meeting a target for blood sugar, cholesterol and blood pressure control but that improvement seemed to lessen over time.

Why The Research Is Interesting: Reducing vascular and cardiovascular risks related to type 2 diabetes requires blood sugar control along with control of blood pressure and cholesterol. Roux-en-Y gastric bypass surgery is effective at achieving these diabetes treatment targets but whether the effects are long-lasting is unknown. The current study reports on longer-term outcomes for participants in a randomized clinical trial after five years.

Who and When: 120 obese adults with type 2 diabetes (half underwent Roux-en-Y gastric bypass surgery plus lifestyle and medical management interventions, the other half received lifestyle and medical management interventions alone); five-year follow up ended in 2016.

Study Measures: A composite measure of diabetes control: hemoglobin A_1c less than 7.0 percent, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg after five years.

How (Study Design): Five year follow-up of patients randomized to Roux-en-Y gastric bypass surgery plus lifestyle and medical management interventions or lifestyle and medical management interventions alone.

Authors: Charles Billington, M.D., University of Minnesota, Minneapolis, and coauthors

Results: Patients who underwent gastric bypass surgery along with lifestyle and medical management interventions showed continued improvement at achieving a composite measure of diabetes control after five years but with some diminished effectiveness.

Study Limitations: Participants had diabetes for an average of nine years when they entered the study so the treatment effect on patients who had diabetes for a shorter time could be different.

Study Conclusions: While there was better achievement of diabetes control targets after five years, the effect was diminished over time so more follow-up is needed to understand if the improvement persists.

Related material:

The following related elements from this issue of JAMA are also available on the For The Media website:

— Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity

— Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity

— Association of Bariatric Surgery Using Laparoscopic Banding, Roux-en-Y Gastric Bypass, or Laparoscopic Sleeve Gastrectomy vs Usual Care Obesity Management With All-Cause Mortality

— Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities

— Editorial: Comparing the Outcomes of Sleeve Gastrectomy and Roux-en-Y Gastric Bypass for Severe Obesity

— Editorial: Reimagining Obesity in 2018 – A JAMA Theme Issue on Obesity

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.20813)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, JANUARY 9, 2018

Media advisory: To contact corresponding author Alireza Atri, M.D., Ph.D., email Dean Fryer at FryerD@sutterhealth.org. The full study is available on the For The Media website.

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Bottom Line: The use of the drug idalopirdine for six months did not improve or reduce the loss of cognition for patients with mild to moderate Alzheimer disease.

Why The Research Is Interesting: Two phase 2 trials have suggested that a certain type of drug, a selective 5-hydroxytryptamine-6 receptor antagonist, such as idalopirdine, may improve cognition in Alzheimer disease when added with another type of drug, cholinesterase inhibitors.

Who: 2,525 patients ages 50 years or older with mild to moderate Alzheimer disease

When: October 2013 to January 2017

What (Study Measures): Changes in measures of cognition from study entry to 24 weeks.

How (Study Design): Three randomized clinical trials, in which patients were assigned to receive idalopirdine or placebo added to a cholinesterase inhibitor. Randomized clinical trials allow for the strongest inferences to be made about the true effect of an intervention such as a medication or a procedure.

Authors: Alireza Atri, M.D., Ph.D., of California Pacific Medical Center, San Francisco, and Brigham and Women’s Hospital/Harvard Medical School, Boston, and coauthors

Results and Study Conclusions: Six months of idalopirdine treatment added to cholinesterase inhibitor therapy did not improve cognition or decrease cognitive loss in patients with mild to moderate Alzheimer disease. These findings do not support the use of idalopirdine for the treatment of Alzheimer disease.

Study Limitations: There was no requirement for evidence of Alzheimer disease biomarker positivity for inclusion in a trial, which may have allowed some patients to be included without having Alzheimer disease pathology.

Related material: The following related elements also are available on the For The Media website:

• The editorial, “Lack of Benefit With Idalopirdine for Alzheimer Disease,” by David A. Bennett, M.D., Rush University Medical Center, Chicago.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.20373)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, JANUARY 9, 2018

Media advisory: To contact the U.S. Preventive Services Task Force, email the Media Coordinator at Newsroom@USPSTF.net or call 202-572-2044. The full report is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.19342

Bottom Line: The U.S. Preventive Services Task Force (USPSTF) cannot assess the effectiveness of routine screening of children and adolescents for scoliosis because the evidence available in the medical literature on the benefits and harms of scoliosis screening is unclear.

Background: The USPSTF routinely makes recommendation statements about the effectiveness of preventive care services. This one on screening for idiopathic scoliosis, a common form of curvature of the spine whose cause is unknown, is an update from 2004 when the USPSTF concluded the harms of screening outweighed potential benefits.

Recommendation:

Related material

The following related elements from The JAMA Network are also available on the For The Media website:

— Screening for Adolescent Idiopathic Scoliosis – Evidence Report and Systematic Review for the US Preventive Services Task Force

— JAMA editorial: Evolving Recommendations for Scoliosis Screening – A Compelling Need for Further Research

— JAMA Pediatrics editorial: Early Detection of Scoliosis—What the USPSTF “I” Means for Us

— JAMA Patient Page: Screening for Scoliosis in Adolescents

For more details and to read the full report, please visit the For The Media website.

(doi:10.1001/jama.2017.19342)

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.

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, JANUARY 2, 2018

Media advisory: To contact Tanjala S. Purnell, Ph.D., M.P.H., email Vanessa McMains at Vmcmain1@jhmi.edu.  The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.19152

Bottom Line: Black and Hispanic patients are less likely than white patients to receive a live donor kidney after two years on a waiting list, with an increase in disparity over the last two decades.

Why The Research Is Interesting: Transplantation with a kidney from a live donor is associated with better medical outcomes and quality of life for patients with end-stage kidney disease compared to long-term dialysis treatment or kidney transplantation from a deceased donor. Because racial and ethnic minority patients are known to be less likely than white patients to receive a live donor kidney, dozens of changes have been made to transplant processes over the last 2 decades to reduce the disparities.

Who and When: 453,162 first-time candidates for kidney transplantation between 1995-2014, with follow-up through 2016

What (Study Measures): Race and ethnicity (exposures); time to kidney transplantation from a live donor (outcome)

How (Study Design): A secondary analysis of an observational study using transplant registry data where researchers are not intervening for purposes of the study and cannot control natural differences that could explain the study findings.

Authors: Tanjala S. Purnell, Ph.D., M.P.H., Johns Hopkins School of Medicine, Baltimore, and coauthors.

Results: Racial and ethnic disparities in live donor kidney transplantation increased from 1995 to 2014. Cumulative incidence in the chart below, a measure of the frequency of kidney transplants from live donors after two years on a waiting list, increased for whites and Asians and decreased for Blacks and Hispanics.

Study Limitations: The study could not identify reasons for the disparities, such as patient preference or trends in willingness of live healthy donors to donate kidneys.

Study Conclusions: Existing strategies in place for reducing racial and ethnic disparities in live donor kidney transplantation may not be effective and should be revisited.

Related material: The following related elements also are available on the For The Media website

• The editorial, “Disparities in Live Donor Kidney Transplantation,” by Colleen L. Jay, M.D., M.S.C.I., and Francisco G. Cigarroa, M.D., University of Texas Health Science Center, San Antonio.

Links to related studies previously published by The JAMA Network:

Implementation of the Affordable Care Act and Solid-Organ Transplantation Listings in the United States

Variation in Dialysis Facility Referral for Kidney Transplantation Among Patients With End-Stage Renal Disease in Georgia

Age-Related Kidney Transplant Outcomes

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.19152)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, JANUARY 2, 2018

Media advisory: To contact corresponding author Wei Bao, M.D., Ph.D., email Tom Moore at thomas-moore@uiowa.edu. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.17812

Bottom Line: The frequency of autism spectrum disorder among U.S. children and adolescents was stable from 2014-2016 based on data from a nationally representative annual survey.

Why The Research Is Interesting: Previous surveys have reported a steady increase in the frequency of autism spectrum disorder (ASD) in U.S. children over the past two decades but a recent estimate suggested a plateau in 2012.

Who: 30,502 U.S. children and adolescents

What and When: Estimate of the frequency of ASD from 2014-2016 using data from the National Health Interview Survey

How (Study Design): This is a descriptive study, so the researchers did not gather information about underlying causes for the findings and cannot make conclusions about their medical significance.

Authors: Wei Bao, M.D., Ph.D., University of Iowa, Iowa City, and coauthors.

Results – There was no apparent increase over the three year study period in the frequency of ASD.

Study Limitations: ASD diagnosis was self-reported rather than measured or diagnosed by experts in child health.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.17812)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, DECEMBER 26, 2017

Media advisory: To contact Joel D. Schwartz, Ph.D., email Marge Dwyer at mhdwyer@hsph.harvard.edu. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.17923

Bottom Line: Short-term exposure to air pollution at levels below current air quality standards were associated with a higher risk of death in older adults.

Why The Research Is Interesting: The Clean Air Act requires that National Ambient Air Quality Standards for fine particulate matter and ozone be reviewed every five years. Estimates of the risk of death at air pollution levels below the current standards are needed and a large study population is necessary to calculate those.

Who and When: Medicare patients throughout the United States from 2000-2012 living in more than 39,000 zip codes.

What (Study Measures): Estimated daily ambient fine particulate matter and ozone levels (exposures); death (outcome)

How (Study Design): This is a case-crossover study, a kind of study design used in epidemiology to study outcomes from a suspected transient exposure like air pollution in a large population over time.

Authors: Joel D. Schwartz, Ph.D., of the Harvard T.H. Chan School of Public Health, Boston, and coauthors

Results: Daily increases in fine particulate matter and ozone were associated with increased risk of death among more than 22 million Medicare beneficiaries, even when fine particulate matter and ozone levels were below current air quality standards.

Study Limitations: The findings are unlikely to be generalizable to adults younger than those enrolled in Medicare.

Study Conclusions: Current national air quality standards may need to be reevaluated because exposure to fine particulate matter and ozone at levels below those standards were associated with increased risk of death in a study of the Medicare population.

Related material: The following related material is available on the For The Media website:

• The editorial, “Low-Level Air Pollution Associated With Death,” by Junfeng Zhang, Ph.D., of Duke University, Durham, North Carolina.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.17923)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, DECEMBER 26, 2017

Media advisory: To contact Jia-Guo Zhao, M.D., email orthopaedic@163.com. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.19344

Bottom Line: Supplements containing calcium, vitamin D or both did not appear to protect against hip fracture and other bone breaks in older adults.

Why The Research Is Interesting: Practice guidelines recommend calcium and vitamin D supplements for older people to prevent fractures in those with osteoporosis; previous studies have come to mixed conclusions about an association between supplements and fracture risk.

Who and What: 51,145 adults over 50 who lived in their communities and not institutions, such as nursing homes and residential care facilities; the adults participated in 33 randomized clinical trials comparing supplement use (calcium, vitamin D or both) with placebo or no treatment and new fractures.

How (Study Design): This was a meta-analysis. A meta-analysis combines the results of multiple studies identified in a systematic review and quantitatively summarizes the overall association between the same exposure (supplements containing calcium, vitamin D or both) and outcomes (fracture) across all studies.

Authors: Jia-Guo Zhao, M.D., Tianjin Hospital, Tianjin, China, and coauthors

Results: Supplements were not associated with less risk for new fractures, regardless of the dose, the sex of the patient, their fracture history, calcium intake in their diet or baseline vitamin D blood concentrations.

Study Limitations: Some trials included in the analysis didn’t test baseline vitamin D blood concentration for all participants; the results for some subgroups might have been different if all individuals were tested.

Study Conclusions: These findings do not support routine use of supplements containing calcium, vitamin D, or both by older community-dwelling adults for prevention of fracture.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.19344)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, DECEMBER 19, 2017

Media advisory: To contact Roger Stupp, M.D., email Kristin Samuelson at kristin.samuelson@northwestern.edu. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.18718

Bottom Line: Patients with glioblastoma, an aggressive brain tumor who received a type of electric fields therapy that interferes with cell division had better overall survival and survival without progression of the tumor compared to standard chemotherapy.

Why The Research Is Interesting: Glioblastoma is the most common and aggressive brain tumor, with only 1 in 4 patients surviving two years after diagnosis. There has been little progress in treating these tumors. Tumor-treating fields (TTFields) are a type of electric fields therapy that interferes with cell division by delivering low-intensity electric fields to the tumor through electrodes on the scalp and connected to a portable device.

Who and When: 695 patients with glioblastoma whose tumor was surgically removed or biopsied and who had completed chemotherapy. Patients were enrolled in the study from 2009-2014 and followed up through 2016.

What: Patients were treated with either TTFields plus the chemotherapy drug temozolomide (n = 466) or temozolomide alone (n = 229). Researchers measured survival without progression of the tumor and overall survival.

How (Study Design): This was a randomized clinical trial (RCT), which allows for the strongest inferences to be made about the true effect of an intervention. However, not all RCT results can be replicated in real-world settings because patient characteristics or other variables may differ from those that were studied in the RCT.

Authors: Roger Stupp, M.D., Northwestern University Feinberg School of Medicine, Chicago, and coauthors

Results: The addition of TTFields to chemotherapy vs chemotherapy alone resulted in improvement in overall survival and progression-free survival.

Study Limitations: Participants and researchers knew of the treatments because it was not feasible practically and it was ethically unacceptable to expose patients to a sham device.

Featured Image:

What The Image Shows: The improved rate of progression-free survival (panel A) and overall survival (panel B) of TTFields plus chemotherapy vs chemotherapy alone. (Click on the image for a full-size version. Right click to “save image as” to download.)

Related material: The following related elements also are available on the For The Media website:

• An animated summary video, available for viewing on this page and to embed on your website. Copy and paste the embed code below to embed the summary video on your website. 

<div style="display: block; position: relative; max-width: 300px;"><div style="padding-top: 50%;"><iframe src="//players.brightcove.net/864352215001/default_default/index.html?videoId=5677755486001" allowfullscreen webkitallowfullscreen mozallowfullscreen style="width: 100%; height: 100%; position: absolute; top: 0px; bottom: 0px; right: 0px; left: 0px;"></iframe></div></div>

• JAMA previously published the interim analysis of this RCT.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.18718)

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.

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, DECEMBER 19, 2017

Media advisory: To contact Gabriele Saccone, M.D., email gabriele.saccone.1990@gmail.com. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.18956

Bottom Line: Pregnant women with a short cervix who used a small silicone ring called a cervical pessary to keep their cervix closed had a lower rate of preterm birth at less than 34 weeks.

Why The Research Is Interesting: Preterm birth is a major cause of illness, disability and death for infants. A cervical pessary is intended to keep the cervix closed and to change the inclination of the cervical canal but the results of randomized clinical trials have been contradictory.

Who and When: 300 women with a short cervix and without a history of  sudden preterm births; the clinical trial was conducted from 2016-2017

What: Half of the woman had a cervical pessary inserted and half did not (intervention); spontaneous preterm birth at less than 34 weeks of gestation (outcome)

How (Study Design): This was a randomized clinical trial. Randomized clinical trials (RCTs) allow for the strongest inferences to be made about the true effect of an intervention. However, not all RCT results can be replicated in real-world settings because patient characteristics or other variables may differ from those that were studied in the RCT.

Authors: Gabriele Saccone, M.D., University of Naples Federico II, Naples, Italy and coauthors.

Results: Women who used a cervical pessary had a lower rate of spontaneous preterm birth.

Study Limitations: The trial was conducted at one facility and that raises questions about the generalizability of its findings.

Study Conclusions:  Women with a short cervix and without a history of spontaneous preterm birth who used a cervical pessary had a lower rate of spontaneous preterm birth compared with women who did not use the device. The results must be confirmed in multicenter clinical trials.

Related material: The following related elements also are available on the For The Media website:

• The editorial, “Cervical Pessary to Prevent Preterm Birth,” by Robert M. Silver, M.D., and D. Ware Branch, M.D., of the University of Utah Health Sciences Center, Salt Lake City

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.18956

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, DECEMBER 12, 2017

Media advisory: To contact Babak Ehteshami Bejnordi, M.S., email ehteshami@babakint.com. The full study is available on the For The Media website.

Video and Audio Content: There is a JAMA Report video for this study. It is available at this link, and includes broadcast-quality downloadable video files, B-roll, scripts and other images. Please email mediarelations@jamanetwork.org with any questions.

Embed the JAMA Report video: Copy and paste the embed code below to embed the JAMA Report video story of this study on your website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.14585

Bottom Line: Computer algorithms detected the spread of cancer to lymph nodes in women with breast cancer as well as or better than pathologists.

Why The Research Is Interesting: Digital imaging of tissue sample slides for pathology has become possible in recent years because of advances in slide scanning technology. Artificial intelligence, where computers learn to do tasks that normally require  human intelligence, has potential for making diagnoses. Using computer algorithms to analyze digital pathology slide images could potentially improve the accuracy and efficiency of pathologists.

Who, What and When: Researchers competed in an international challenge in 2016 to produce computer algorithms to detect the spread of breast cancer by analyzing tissue slides of sentinel lymph nodes, the lymph node closest to a tumor and the first place it would spread. The performance of the algorithms was compared against the performance of a panel of 11 pathologists participating in a simulation exercise.

Authors: Babak Ehteshami Bejnordi, M.S., Radboud University Medical Center, Nijmegen, the Netherlands and coauthors

Results:

• Some computer algorithms were better at detecting cancer spread than pathologists in an exercise that mimicked routine pathology workflow.
• Some algorithms were as good as an expert pathologist interpreting images without any time constraints.

Study Limitations: The test data on which algorithms and pathologists were evaluated are not comparable to the mix of cases pathologists encounter in clinical practice.

Study Conclusions: Computer algorithms detected the spread of cancer to lymph nodes in women with breast cancer as well as or better than pathologists. Evaluation in a clinical setting is required to determine the benefit of using artificial intelligence in pathology to detect cancer requires.

Featured Image:

What The Image Shows: Images of lymph node tissue sections used to test the ability of the deep learning algorithms to detect cancer metastasis. (Click on the image for a full-size version. Right click to “save image as” to download.)

Related material: The following material is available on the For The Media website:

The editorial, “Deep Learning Algorithms for Detection of Lymph Node Metastases From Breast Cancer,” by Jeffrey Alan Golden, M.D., Brigham and Women’s Hospital, Boston

The study, “Development and Validation of a Deep Learning System for Diabetic Retinopathy and Related Eye Diseases Using Retinal Images From Multiethnic Populations With Diabetes,” by Tien Yin Wong, M.D., Ph.D., Singapore National Eye Center, Singapore, and coauthors

Embed the JAMA Report video: Copy and paste the embed code below to embed the JAMA Report video story of this study on your website.

</p>
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For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.14585)

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.

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, DECEMBER 12, 2017

Media advisory: To contact corresponding author Tien Yin Wong, M.D., Ph.D., email wong.tien.yin@snec.com.sg. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.18152

Bottom Line: A computing system with artificial intelligence that can learn to do tasks that normally require human intelligence could detect retinal images that did and did not show diabetic retinopathy and related eye diseases in multiethnic populations.

Why The Research Is Interesting: Diabetic retinopathy is a vision-threatening eye disease. One of the challenges of screening for diabetic retinopathy is the lack of trained individuals to assess retinal images.

Who: 494,661 retinal images from Chinese, Indian, Malay, Hispanic, African-American and White patients.

What (Study Measures): To test the performance of a deep learning computing system that was developed and trained to classify retinal images to detect diabetic retinopathy, possible glaucoma and age-related macular degeneration and compare it with human evaluators of the images.

Authors: Tien Yin Wong, M.D., Ph.D., of the Singapore National Eye Center, Singapore, and coauthors

Results: The computing system had high rates of correctly identifying retinal images with and without diabetic retinopahy and related eye diseases.

Study Limitations: Improvements could be made in the data sets used to train and test the computing system.

Study Conclusions: More research is necessary to evaluate how such a computing system could be used in health care settings to improve vision outcomes.

Related material:

The following related elements also are available on the For The Media website:

• The study, “Diagnostic Assessment of Deep Learning Algorithms for Detection of Lymph Node Metastases in Women With Breast Cancer,” by Babak Ehteshami Bejnordi, M.S., and colleagues.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.18152)

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.

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, DECEMBER 12, 2017

Media advisory: To contact the U.S. Preventive Services Task Force, email the Media Coordinator at Newsroom@USPSTF.net or call 202-572-2044. The full report is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.18261

Bottom Line: The U.S. Preventive Services Task Force (USPSTF) recommends against the use of combined estrogen and progestin in postmenopausal women, or estrogen alone in postmenopausal women who have had a hysterectomy, to prevent chronic conditions such as heart disease, dementia and stroke.

Background: The USPSTF routinely makes recommendations about the effectiveness of preventive care services. This latest recommendation statement on the use of hormone therapy in postmenopausal women is an update from 2012. The topic is important to many women because the risk of chronic conditions increase with age; however, whether menopause increases this risk and whether hormone replacement decreases it is uncertain.

How: The USPSTF recommendation statement follows a review of evidence from clinical trials on the benefits and harms of hormone therapy taken orally or applied through the skin.

Related material

The following related elements from The JAMA Network are also available on the For The Media website:

— Hormone Therapy for the Primary Prevention of Chronic Conditions in Postmenopausal Women – Evidence Report and Systematic Review for the US Preventive Services Task Force

— JAMA Editorial: Menopausal Hormone Therapy for Primary Prevention of Chronic Disease

— JAMA Cardiology Editorial: Menopausal Hormone Therapy for the Primary Prevention of Chronic Conditions

— JAMA Internal Medicine Editorial: Evidence for Postmenopausal Hormone Therapy to Prevent Chronic Conditions

— JAMA Patient Page: Hormone Therapy for Primary Prevention of Chronic Conditions in Postmenopausal Women

For more details and to read the full report, please visit the For The Media website.

(doi:10.1001/jama.2017.18261)

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.

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, DECEMBER 12, 2017

Media advisory: To contact Jie Qiao, M.D., Ph.D., email jie.qiao@263.net; to contact Tianpei Hong, M.D., Ph.D., email tpho66@bjmu.edu.cn. The full study is available on the For The Media website.

Want to embed a link to this report in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.18249

Bottom Line: Treatment with the thyroid medication levothyroxine did not improve pregnancy outcomes for women in China undergoing in vitro fertilization and embryo transfer for infertility.

Why The Research Is Interesting: Women who test positive for thyroid autoantibodies are reported to be at higher risk for miscarriage. Limited studies with conflicting results exist on whether levothyroxine treatment can improve pregnancy outcomes among women who test positive for thyroid autoantibodies but have normal thyroid function.

Who and When: 600 women who had normal thyroid function and tested positive for thyroid autoantibodies treated for infertility at a Beijing hospital from September 2012 to March 2017.

What (Study Measures): Half the women received levothyroxine treatment and half did not. Investigators measured rates of miscarriage, pregnancy and live-births

How (Study Design): This was a randomized clinical trial (RCT), which allows for the strongest inferences to be made about the true effect of an intervention. However, not all RCT results can be replicated in real-world settings because patient characteristics or other variables may differ from those that were studied in the RCT.

Authors: Jie Qiao, M.D., Ph.D., Tianpei Hong, M.D., Ph.D., of the Peking University Third Hospital, Beijing, and coauthors.

Results: There was no important differences between groups in the proportion of women who miscarried, became pregnant, or delivered live babies:

Study Limitations: This study was a single-center trial. Caution should be used when extending this result to other patient populations.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.18249)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, DECEMBER 5, 2017

Media advisory: To contact corresponding author Rahi Abouk, Ph.D., email Theresa Ross at RossT@wpunj.edu. The full study is available on the For The Media website.

Want to embed a link to this study in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.17627

Bottom Line: Statewide implementation of mandatory policies to screen newborns for the most serious congenital heart defects was associated with an estimated decrease in infant cardiac deaths.

Why The Research Is Interesting: Congenital heart disease accounted for 6 percent of U.S. infant deaths from 1999 to 2006. In 2011, critical congenital heart disease was added to the U.S. Recommended Uniform Screening Panel for newborns but it is not known if the policy requiring screen for the most serious defects is associated with lower infant death rates.

Who and When: Infants born between 2007 and 2013.

What (Study Measures): Before-after comparison of early infant deaths (between 24 hours and 6 months of age) from critical congenital heart disease or other congenital cardiac causes in states with mandatory vs nonmandatory screening policies. As of June 2013, eight states had implemented mandatory screening policies, five states had voluntary screening policies, and nine states had adopted but not yet implemented mandates.

How (Study Design): This is an observational study. Researchers are not intervening for purposes of the study so they cannot control natural differences that could explain the study findings.

Authors: Rahi Abouk, Ph.D., William Paterson University, Wayne, New Jersey, and coauthors.

Results: There was a decrease in estimated infant cardiac death rates for states that implemented mandatory screening policies compared to states that did not.

Featured Image:

What The Image Shows: States with mandatory screening policies (yellow dots) had lower critical congenital heart disease deaths than states without, and the between-state differences increased after implementation of the screening requirement in 2011. (Click on the image for a full-size version. Right click to “save image as” to download.)

Study Limitations: Estimates of death rates were imprecise because of the small number of deaths and the small number of states with fully implemented screening mandates.

Study Conclusions: The findings support the use of statewide policies requiring newborn critical congenital heart disease screening as one means to reduce U.S. infant mortality.

Related material:

The following related elements also are available on the For The Media website:

The editorial, “The Success of State Newborn Screening Policies for Critical Congenital Heart Disease,” by Alex R. Kemper, M.D., M.P.H., M.S., of Nationwide Children’s Hospital, Columbus, Ohio, and coauthors.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.17627)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, DECEMBER 5, 2017

Media advisory: To contact corresponding author Aaron S. Kesselheim, M.D., J.D., M.P.H., email Elaine St. Peter at estpeter@bwh.harvard.edu. The full study is available on the For The Media website.

Want to embed a link to this study in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.14896

Bottom Line: Drugs reviewed by the FDA in programs intended to speed drug development  were approved nearly a year quicker than drugs reviewed by the FDA through normal processes.

Why The Research Is Interesting: The U.S. Food and Drug Administration (FDA) has four programs to speed the development and review of drugs treating serious diseases. Clinical development times for drugs in these programs, particularly the newly created breakthrough program (enacted in 2012), have not been comprehensively assessed.

What (Study Measures) and When: Comparison of clinical development times for drugs and biologics approved by the FDA between January 2012 and December 2016 in expedited vs non-expedited programs.

How (Study Design): This is an observational study. Because researchers are not intervening for purposes of the study they cannot control natural differences that could explain the study findings.

Authors: Aaron S. Kesselheim, M.D., J.D., M.P.H., of Brigham and Women’s Hospital, Boston, and coauthors.

Results:

— Of 174 new drug approvals, 60 percent were in one or more expedited programs.

— The median development time for drugs in at least one expedited program was 7.1 years compared with 8 years for nonexpedited drugs.

Study Limitations: Only approved drugs were analyzed.

Related material

These previous articles from JAMA are also available:

Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration

Balancing the Need for Access With the Imperative for Empirical Evidence of Benefit and Risk

New “21st Century Cures” Legislation – Speed and Ease vs Science

Physicians’ Knowledge About FDA Approval Standards and Perceptions of the “Breakthrough Therapy” Designation

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.14896)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, NOVEMBER 28, 2017

Media advisory: To contact corresponding author Dina Kao, M.D., F.R.C.P.C., email Ross Neitz at rneitz@ualberta.ca. The full study is available on the For The Media website.

Want to embed a link to this study in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.17077

Bottom Line: Fecal transplant administered by swallowing a capsule was no worse than transplant using colonoscopy to reduce the risk of recurrent Clostridium difficile.

Why The Research Is Interesting: Clostridium difficile infection (CDI) causes inflammation of the colon and severe diarrhea. The infection occurs when normal gut bacteria are disrupted. Fecal transplants to re-establish normal gut bacteria are the most effective treatment for preventing CDI in people who have already had the infection. Giving the treatment by a pill would save time and cost relative to giving the treatment by colonoscopy if the two treatments were no different.

Who and When: 116 patients with recurrent CDI enrolled from October 2014 to September 2016 and followed through 2016.

What (Study Measures):

Exposure: Patients were nearly evenly divided to receive a fecal transplant using a capsule or colonoscopy.

Outcome: Number of recurrent CDIs 12 weeks after fecal transplant.

How (Study Design): This was a noninferiority randomized clinical trial (RCT). Noninferiority RCTs are designed to assess whether one treatment (in this case capsule-based fecal transplant) was “no worse” than a comparison treatment (colonoscopy-based fecal transplant).

Authors: Dina Kao, M.D., F.R.C.P.C., of the University of Alberta, Edmonton, Canada, and coauthors.

Results: Recurrent CDI was prevented after a single treatment in 96 percent of patients in both groups after 12 weeks; more patients who received capsules rated their experience as “not at all unpleasant.”

Study Limitations: Patients with severe and complicated CDI were excluded, so the findings may not apply to those cases.

Study Conclusions: Fecal transplant using oral capsules may be as effective as colonoscopy to prevent recurrent CDI.

Related material:

The following related elements also are available on the For The Media website:

• The editorial, “Capsules for Fecal Microbiota Transplantation in Recurrent Clostridium difficile Infection,” by Preeti N. Malani, M.D., M.S.J., of the University of Michigan Health System, Ann Arbor, and Associate Editor, JAMA, and coauthors

Previous articles available from JAMA include:

Frozen vs Fresh Fecal Microbiota Transplantation and Clinical Resolution of Diarrhea in Patients With Recurrent Clostridium difficile Infection;

Expanded Evidence for Frozen Fecal Microbiota Transplantation for Clostridium difficile Infection

Oral, Capsulized, Frozen Fecal Microbiota Transplantation for Relapsing Clostridium difficile Infection

Bezlotoxumab (Zinplava) for Prevention of Recurrent Clostridium Difficile Infection

A Patient Page, Fecal Microbiota Transplantation

Diagnosis and Treatment of Clostridium difficile in Adults

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.17077)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, NOVEMBER 28, 2017

Media advisory: To contact corresponding author Daniel Pincus, M.D., email Heidi Singer at Heidi.Singer@utoronto.ca. The full study is available on the For The Media website.

Want to embed a link to this study in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.17606

Bottom Line:  Waiting more than 24 hours to undergo hip fracture surgery may be associated with an increased risk of death and complications.

Why The Research Is Interesting: Disagreements remain about acceptable delay for surgical repair of hip fracture. Guidelines in the U.S. and Canada recommend surgery within 48 hours.

Who and When: 42,230 adults who had hip fracture surgery between April 2009 and March 2014 at 72 hospitals in Ontario, Canada.

What (Study Measures): Time in hours from emergency department arrival until surgery (exposure); death within 30 days of hospital admittance for hip fracture surgery (outcome).

How (Study Design): This is an observational study. Because researchers are not intervening for purposes of the study they cannot control natural differences that could explain study findings. In observational studies, researchers observe exposures and outcomes for patients as they occur naturally in clinical care or real life. Because researchers are not intervening for purposes of the study they cannot control natural differences that could explain study findings so they cannot prove a cause-and-effect relationship.

Authors: Daniel Pincus, M.D., of the University of Toronto, and coauthors

Results: Patients who had surgery for hip fracture after 24 hours had an increased risk of death compared to patients who had surgery within 24 hours (6.5 percent vs 5.8 percent). The risk of complications, such as heart attack, deep vein thrombosis, pulmonary embolism, and pneumonia, were also higher for patients who had surgery after 24 hours.

Study Limitations: Sick patients who may have died awaiting surgery were not included in the study.

Featured Image:

What The Image Shows: Gradual increase in risk of death by wait time for hip fracture surgery. Risk seems to decrease slightly until a 24 hour delay, at which time risk begins to increase continuously with time (Click on the image for a full-size version. Right click to “save image as” to download.)

Related material:

The following related elements also are available on the For The Media website:

• The editorial, “Timing of Operations and Outcomes for Patients With Hip Fracture—It’s Probably Not Worth the Wait,” by Mark S. Vrahas, M.D., and Harry C. Sax, M.D., of Cedars Sinai Medical Center, Los Angeles.
• The previous study from JAMA Internal Medicine, “Survival and Functional Outcomes After Hip Fracture Among Nursing Home Residents.”

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.17606)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, NOVEMBER 21, 2017

Media advisory: To contact corresponding author Jeffrey P. Krischer, Ph.D., email Tina Meketa at tmeketa@usf.edu.  The full study is available on the For The Media website.

Want to embed a link to this study in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.17070

Bottom Line: A daily insulin pill did not delay or prevent the development of type 1 diabetes among relatives of people with type 1 diabetes at increased risk of this disease.

Why The Research Is Interesting: A previous trial of oral insulin to prevent Type 1 diabetes hinted that in a group of relatives with insulin antibodies, oral insulin might prevent or delay the disease. Prevention or delay of diabetes would have major clinical ramifications.

Who: Children and adults with normal glucose tolerance who were relatives of patients with type 1 diabetes and had an increased risk for the disease because they had at least two autoantibodies, including insulin autoantibodies.

When: Participants were enrolled in the trial March 2007 through December 2015.

How (Study Design): This was a randomized clinical trial. Participants were randomized to 7.5 mg oral insulin or placebo as follows:

What (Study Measures): The time from randomization to the development of type 1 diabetes.

Authors: Jeffrey P. Krischer, Ph.D., of the University of South Florida College of Medicine, Tampa, and coauthors with the Writing Committee for the Type 1 Diabetes TrialNet Oral Insulin Study Group

Results: During a median follow-up of 2.7 years, diabetes was diagnosed in 58 participants (28.5 percent) in the insulin pill group and 62 (33 percent) in the placebo group. Time to diabetes was not significantly different between the two groups.

Study Limitations: There are likely many reasons and mechanisms by which type 1 diabetes develops, and the trial assumed that all participants were similar in those characteristics and in their potential response to oral insulin.

Study Conclusions: Among autoantibody-positive relatives of patients with type 1 diabetes, a 7.5 mg insulin pill daily compared with placebo did not delay or prevent the development of type 1 diabetes. These findings do not support oral insulin as used in this study for diabetes prevention.

Featured Image:

What The Image Shows: There was no significant difference over the study period between the insulin pill group and placebo in the development of type 1 diabetes. (Click on the image for a full-size version. Right click to “save image as” to download.)

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.17070)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, NOVEMBER 21, 2017

Media advisory: To contact corresponding author Melissa C. Mercado, Ph.D., M.Sc., M.A., contact CDC Media Relations. The full study is available on the For The Media website.

Want to embed a link to this study in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.13317

Bottom Line: Emergency department visits for self-inflicted injuries among young females increased significantly in recent years, particularly among girls 10 to 14.

Why The Research Is Interesting: Young people in the United States have high rates of nonfatal self-inflicted injuries that require medical attention; self-inflicted injury is a strong risk factor for suicide.

Who: Children, adolescents and young adults in the United States ages 10 to 24.

When: 2001-2015

What (Study Measures): Rates of emergency department visits for nonfatal self-inflicted injuries using national survey data.

How (Study Design): This is an observational study. Because researchers are not intervening for purposes of the study they cannot control natural differences that could explain study findings.

Authors: Melissa C. Mercado, Ph.D., M.Sc., M.A., of the Centers for Disease Control and Prevention, Atlanta and coauthors

Results:

Overall

— 43,138 emergency department visits for self-inflicted injury 2001-2015

— 5.7 percent annual relative increase in visits after 2008

— Poisoning the most common method of injury

Females

— 8.4 percent annual relative increase in visits from 2009-2015

— 18.8 percent annual relative increase in visits after 2009 among girls 10 to 14

Males

— Rates of visits stable 2001-2015

Study Limitations: Because the study focused on emergency department cases, rates among all youths ages 10-24 are probably underestimated.

Study Conclusions: Rates of self-injury among females appear to be increasing since 2009, a finding that points to the need for the implementation of suicide and self-harm prevention strategies within health systems and communities.

Featured Image:

What The Image Shows: Panel A illustrates stable rates of nonfatal self-inflicted injury emergency department visits for males ages 10 to 24 years from 2001-2015. Panel B shows increases in rates for females ages 10-24 years. (Click on the image for a full-size version. Right click to “save image as” to download.)

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.13317)

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

#  #  #

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

This Arts and Medicine essay explores the relevance of writer and artist William S. Burroughs to clinical medicine, and his importance to the author’s career as a Parkinson disease researcher.

Also available for viewing, the documentary video: Mentored by a Madman – The William Burroughs Experiment. The video was produced by Ben Crowe for Advances in Clinical Neuroscience and Rehabilitation and for Notting Hill Editions.

Embed this video: Copy and paste the embed code below to embed this video on your website.

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JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, NOVEMBER 14, 2017

Media advisory: To contact corresponding author Sarka Lisonkova, M.D., Ph.D., email Heather Amos at heather.amos@ubc.ca. The full study is available on the For The Media website.

Want to embed a link to this study in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.16191

Bottom Line: Being over- or underweight before pregnancy was associated with a small increased risk of severe maternal illness or death.

Why The Research Is Interesting: Unhealthy weight during pregnancy is associated with adverse birth outcomes. Less is known about the association between unhealthy weight before pregnancy and maternal complications.

Who and When: 743,630 women who gave birth in Washington State, 2004-2013.

What (Study Measures):

Exposure: Women’s before-pregnancy body mass index

Outcome: Severe maternal illness or death, defined as life-threatening conditions or conditions leading to serious consequences, or complications requiring intensive care unit admission, or maternal death during the hospitalization.

How (Study Design): This is an observational study. In observational studies, researchers observe exposures and outcomes for patients as they occur naturally in clinical care or real life. Because researchers are not intervening for purposes of the study they cannot control natural differences that could explain study findings so they cannot prove a cause-and-effect relationship.

Authors: Sarka Lisonkova, M.D., Ph.D., University of British Columbia and the Children’s and Women’s Hospital and Health Centre of British Columbia, Vancouver, and coauthors

Results: Compared to women with normal body mass index [BMI; 18.5-24.9), absolute risks of severe maternal illness or death per 10,000 women were:

— 28.8 more for underweight women (BMI less than 18.5);

— 17.6 more for overweight women (BMI 25.0-29.9);

— 24.9 more for obese women with a BMI of 30.0-34.9;

— 35.8 more for obese women with a BMI of 35.0-39.9;

— 61.1 more for obese women with a BMI of 40 or greater.

Study Limitations: Despite the large study size, death and a few very rare complications occurred in only a small number of women to be able to assess associations between unhealthy BMI and these specific outcomes. Information on BMI was self-reported and potentially inaccurate.

Study Conclusions: Among pregnant women in Washington State, unhealthy prepregnancy BMI, compared with normal BMI, was associated with a small absolute increase in severe maternal morbidity or mortality.

Related material:

The following related elements also are available on the For The Media website:

• The editorial, “Prepregnancy Obesity and Severe Maternal Morbidity,” by Aaron B. Caughey, M.D., Ph.D.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.16191)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, NOVEMBER 14, 2017

Media advisory: To contact corresponding author Hugh A. Sampson, M.D., email Rachel Zuckerman at rachel.zuckerman@mountsinai.org. The full study is available on the For The Media website.

Want to embed a link to this study in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.16591

Bottom Line: A skin patch that delivered a high dose of peanut protein reduced peanut sensitivity in children and adults with peanut allergy, findings that warrant a phase 3 trial.

Why The Research Is Interesting: Allergy immunotherapy exposes people to a controlled dose of the proteins that trigger allergies so they become less sensitive or no longer sensitive. Peanut immunotherapy with a pill isn’t especially effective and carries the risk of triggering allergy just as eating a peanut would. Skin patch immunotherapy may have potential for more safely and effectively treating peanut allergy.

Who: 221 peanut-allergic patients (age 6-55 years)

When: Phase 2b trial: July 31, 2012 – July 31, 2014. Extension: Patients completing the trial participated in a 2-year extension using the most effective peanut-patch dose to assess efficacy for up to 36 months; extension study completed September 29, 2016.

What (Study Measures): The percentage of treatment responders in each group vs placebo patch after 12 months. Patients were considered treatment responders if it took 1,000 mg or more of peanut protein and/or 10-times the pretreatment amount of peanuts to trigger an allergic reaction.

How (Study Design): This was a phase 2b clinical trial that randomly assigned participants to a peanut patch containing 50 µg, 100 µg or 250 µg of peanut protein or placebo for 12 months. Phase 2b trials confirm the efficacy of an intervention and determine the most effective dose and are typically followed by a phase 3 trial in a broader population. Randomized clinical trials (RCTs) allow for the strongest inferences to be made about the true effect of an intervention such as a medication or a procedure. However, not all RCT results can be replicated in real-world settings because patient characteristics or other variables may differ from those that were studied in the RCT.

Authors: Hugh A. Sampson, M.D., Icahn School of Medicine at Mount Sinai, New York, and coauthors

Results: There were more treatment responders among patients given the 250-µg peanut patch (n = 28; 50 percent) than among patients given the placebo patch (n = 14; 25 percent). There was no difference between the placebo and 100-µg patch. The percentage of patients with one or more treatment-emergent adverse events (largely local skin reactions) was similar across all groups in year 1.

Study Limitations: The primary end point (10-times increase in challenge threshold) may not have been sufficiently stringent for the lowest food challenge doses, which contributed to the higher-than-expected rate of placebo responders. The sample size of each treatment group was relatively small and therefore, the study was not powered to detect a dose-response gradient.

Study Conclusions: These findings support testing of the 250-µg peanut patch dose in a phase 3 trial involving patients with peanut allergy.

Related material:

The following related elements also are available on the For The Media website:

• An animated summary video, available for viewing on this page and to embed on your website. Copy and paste the embed code below to embed the summary video on your website.

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• From JAMA Pediatrics, the article, “Evolution of Guidelines on Peanut Allergy and Peanut Introduction in Infants.”

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.16591)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, NOVEMBER 14, 2017

Media advisory: To contact corresponding author Saeid Shahraz, M.D., Ph.D., email Bethany Romano at bromano@brandeis.edu. The full study is available on the For The Media website.

Want to embed a link to this study in your story? Link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.11927

Bottom Line: The improvement in glycemic control observed between 1998 and 2010 among patients with diabetes appears to have plateaued during 2007-2014. More participants reported having a test for HbA_1c in the prior year and were aware of their HbA_1c result and target.

Why The Research Is Interesting: In 2014, an estimated 30.3 million people  (9.4 percent) in the United  States had diabetes. Improving glycemic control reduces the risk of diabetes-related vascular complications.

Who and When: 2,908 participants of the National Health and Nutrition Examination Survey (NHANES). NHANES is a program of studies designed to assess the health and nutritional status of adults and children in the United States and is unique because it combines interviews and physical examinations. Survey periods for this study were 2007-2008, 2009-2010, 2011-2012, and 2013-2014.

What (Study Measures): Hemoglobin (Hb) A_1c levels, a measure of glycemic control. Glycemic control was defined as good (HbA_1c level < 7 percent); moderate (<8 percent); and poor (> 9 percent).

How (Study Design): A population epidemiology study describes characteristics of health and disease in one or more large populations, typically without detailed information about underlying causes.

Authors: Saeid Shahraz, M.D., Ph.D., of Brandeis University, Waltham, Massachusetts and coauthors

Results:  Glycemic control did not change overall between 2007-2008 and 2013-2014. There was an increase in the proportion of participants who reported have a test for HbA_1c in the prior year and were aware of their HbA_1c result and target.

Study Limitations: The study design does not allow conclusions to be drawn about why the findings.

Study Conclusions: There was no change in glycemic control among people in the U.S. with diabetes between 1998-2010 and 2007-2014.

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.11927)

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

#  #  #

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