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

Media Advisory: To contact Carri R. Warshak, M.D., email Amanda Nageleisen at Amanda.Nageleisen@UCHealth.com.

Related material: The editorial, “Postoperative Antimicrobial Prophylaxis Following Cesarean Delivery in Obese Women,” by David P. Calfee, M.D., M.S., and Amos Grunebaum, M.D., of Weill Cornell Medicine, New York, also is available at the For The Media website.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.10567

JAMA

Among obese women undergoing cesarean delivery, a postoperative 48-hour course of antibiotics significantly decreased the rate of surgical site infection within 30 days after delivery, according to a study published by JAMA.

The rate of obesity among U.S. women has been increasing, and obesity is associated with an increased risk of surgical site infection (SSI) following cesarean delivery. The optimal antibiotic regimen around the time of cesarean delivery to prevent as SSI in this high-risk population is unknown. Carri R. Warshak, M.D., of the University of Cincinnati, and colleagues randomly assigned obese women (prepregnancy BMI 30 or greater) who had received standard intravenous preoperative cephalosporin (an antibiotic) to receive oral cephalexin, 500 mg, and metronidazole, 500 mg (n = 202), vs identical-appearing placebo (n = 201) every 8 hours for a total of 48 hours following cesarean delivery.

The researchers found that the overall rate of SSI (defined as any superficial incisional, deep incisional, or organ/space infections within 30 days after cesarean delivery) was 10.9 percent. Surgical site infection was diagnosed in 6.4 percent of the women in the cephalexin-metronidazole group vs 15.4 percent in the placebo group. There were no serious adverse events, including allergic reaction, reported in either group.

The study notes some limitations, including that the trial was performed at a single site with a high prevalence of obesity, which may not be generalizable to all obstetric practices.

“For prevention of SSI among obese women after cesarean delivery, prophylactic oral cephalexin and metronidazole may be warranted,” the authors write.

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

(doi:10.1001/jama.2017.10567)

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

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

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

Media Advisory: To contact JoAnn E. Manson, M.D., Dr.P.H., email Elaine St. Peter at estpeter@bwh.harvard.edu.

Related material: The editorial, “Menopausal Hormone Therapy – Understanding Long-term Risks and Benefits,” by Melissa McNeil, M.D., M.P.H., of the University of Pittsburgh, also is available at the For The Media website.

Video 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.

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To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.11217

JAMA

Among postmenopausal women in the Women’s Health Initiative trials, use of hormone therapy for 5 to 7 years was not associated with risk of all-cause, cardiovascular or cancer death over 18 years of follow-up, according to a study published by JAMA.

The Women’s Health Initiative (WHI) hormone therapy trials were designed to assess the benefits and risks of menopausal hormone therapy taken for chronic disease prevention by predominantly healthy postmenopausal women. Health outcomes have been reported, but previous publications have generally not focused on all-cause and cause-specific mortality. All-cause mortality is a critically important summary measure representing the net effect of hormone therapy on serious and life-threatening health conditions.

JoAnn E. Manson, M.D., Dr.P.H., of Brigham and Women’s Hospital, Harvard Medical School, Boston, and colleagues examined total and cause-specific mortality during cumulative 18-year follow-up (intervention plus extended post-intervention phases) of the two randomized WHI hormone therapy trials: conjugated equine estrogens (CEE, 0.625 mg/d) plus medroxyprogesterone acetate (MPA, 2.5 mg/d) (n = 8,506) vs placebo (n = 8,102) for 5.6 years (median); or CEE alone (n = 5,310) vs placebo (n = 5,429) for 7.2 years (median). The analysis included postmenopausal women ages 50 to 79 years who were enrolled in the trials between 1993 and1998 and followed up through 2014.

Among 27,347 women who were randomized, mortality follow-up was available for more than 98 percent. During the cumulative 18-year follow-up, 7,489 deaths occurred (1,088 deaths during the intervention phase and 6,401 deaths during post-intervention follow-up). All-cause mortality was 27.1 percent in the hormone therapy group vs 27.6 percent in the placebo group in the overall pooled cohort. Analyses indicated that CEE plus MPA and CEE alone were not associated with increased or decreased risk of all-cause, cardiovascular, or total cancer mortality. During cumulative follow-up, trends in cause-specific mortality across age groups were not significantly different.

Several limitations of the study are noted in the article, including that only one dose, formulation, and route of administration in each trial was assessed; thus, results are not necessarily generalizable to other hormone preparations.

“In view of the complex balance of benefits and risks of hormone therapy, the all-cause mortality outcome provides an important summary measure, representing the net effect of hormone therapy use for 5 to 7 years on life-threatening outcomes,” the authors write.

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

(doi:10.1001/jama.2017.11217)

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

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

Media Advisory: To contact John Maret-Ouda, M.D., email john.maret.ouda@ki.se.

Related material: The editorial, “The Durability of Antireflux Surgery,” by Stuart J. Spechler, M.D., of the Baylor University Medical Center at Dallas, also is available at the For The Media website.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.10981

JAMA

Among patients who underwent laparoscopic antireflux surgery, about 18 percent experienced recurrent gastroesophageal reflux disease (GERD) requiring long-term medication use or secondary antireflux surgery, according to a study published by JAMA.

Gastroesophageal reflux disease is a public health concern in the Western world, affecting approximately 10 to 20 percent of all adults, and  its prevalence has increased in the past two decades. Laparoscopic antireflux surgery with fundoplication (strengthens the valve between the esophagus and stomach) is a treatment alternative in patients with inadequate response to pharmacological treatment. Reflux recurrence after laparoscopic antireflux surgery has not been assessed in a long-term population-based study of unselected patients.

John Maret-Ouda, M.D., of the Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden, and colleagues conducted a study that included 2,655 patients who underwent laparoscopic antireflux surgery.  The patients were followed up for a median of 5.6 years; 17.7 percent had reflux recurrence; 83.6 percent received long-term antireflux medication, and 16.4 percent underwent secondary antireflux surgery. Risk factors for reflux recurrence included female sex (22 percent of women vs. 13.6 percent of men had recurrence of reflux), older age, and comorbidity. Hospital volume of antireflux surgery was not associated with risk of reflux recurrence.

“Laparoscopic antireflux surgery was associated with a relatively high rate of recurrent GERD requiring long-term treatment, diminishing some of the benefits of the operation,” the authors write.

Several limitations of the study are noted in the article, including that there might be variations in clinical practice in regard to coding, especially for diagnoses that are not the primary reason the patient seeks health care.

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

(doi:10.1001/jama.2017.10981)

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

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

EMBARGOED FOR RELEASE: 9 A.M. (ET) MONDAY, SEPTEMBER 11, 2017

Media Advisory: To contact An-Wen Chan, M.D., D.Phil., email Lindsay Jolivet at lindsay.jolivet@wchospital.ca.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.13001

JAMA

An analysis of more than 100 clinical trials found that they were often unregistered, unpublished and had discrepancies in the reporting of primary outcomes, according to a study published by JAMA. The study is being released to coincide with its presentation at the Eighth International Congress on Peer Review and Scientific Publication.

A major aim of trial registration is to help identify and deter the selective reporting of outcomes based on the results. However, it is unclear whether registered outcomes accurately reflect the trial protocol and whether registration improves the reporting of primary outcomes in publications. An-Wen Chan, M.D., D.Phil., of the Women’s College Research Institute, University of Toronto, and colleagues examined adherence to trial registration and its association with subsequent publication and reporting of primary outcomes in 113 clinical trial protocols approved in 2007 by the research ethics committee for the region of Helsinki and Uusimaa, Finland.

Among the trials, 61 percent were prospectively registered (defined as within one month after the trial start date to allow for incomplete start dates and processing delays in the registry) and 57 percent were published. A primary outcome was not defined in 20 percent. Discrepancies between the protocol and publication were more common in unregistered trials (55 percent) than registered trials (6 percent). Discrepancies were defined as (1) a new primary outcome being reported that was not specified as primary in the protocol; or (2) a protocol-defined primary outcome being omitted or downgraded (reported as secondary or unspecified) in the registry or publication.

Prospective registration was significantly associated with subsequent publication (68 percent of registered trials vs 39 percent of unregistered trials). Registered trials were also significantly more likely than unregistered trials to be subsequently published with the same primary outcomes as defined in the protocol (64 percent of registered trials vs 25 percent of unregistered trials).

Limitations of the study include the unclear generalizability beyond the Finnish jurisdiction and the limited sample size.

“Journal editors, regulators, research ethics committees, funders, and sponsors should implement policies mandating prospective registration for all clinical trials. Only with accessible, complete information can interventions be adequately evaluated for patient care,” the authors write.

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

(doi:10.1001/jama.2017.13001)

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

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

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

Media Advisory: To contact Amit G. Singal, M.D., M.S., email Cathy Frisinger at Cathy.frisinger@utsouthwestern.edu. To contact Cedric Rat, M.D., Ph.D., email cedric.rat@univ-nantes.fr.

Related material: The editorial, “Using Outreach to Improve Colorectal Cancer Screening,” by Michael Pignone, M.D., M.P.H., of the University of Texas, Austin, and David P. Miller Jr., M.D., M.S., of the Wake Forest School of Medicine, Winston-Salem, N.C., also is available at the For The Media website.

To place an electronic embedded link to these studies in your story  These links will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.11389  http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.11387

JAMA

Outreach and notification to patients and physicians improved colorectal cancer (CRC) screening among patients who were not up-to-date or nonadherent with CRC screening, according to two studies published by JAMA.

In one study, Amit G. Singal, M.D., M.S., of the University of Texas Southwestern Medical Center, Dallas, and colleagues compared the effectiveness of fecal immunochemical test (FIT) outreach and colonoscopy outreach to increase completion of the CRC screening process (screening initiation and follow-up) within 3 years.

Colorectal cancer is the second leading cause of cancer-related death in the United States; screening can reduce CRC incidence and death. However, screening effectiveness is limited by underuse and suboptimal adherence to guideline-recommended follow-up, including repeat testing for normal test results and diagnostic follow-up of abnormal test results.

In this study, patients ages 50 to 64 years who were not up-to-date with CRC screenings were randomly assigned to mailed FIT outreach (n = 2,400), mailed colonoscopy outreach (n = 2,400), or usual care with clinic-based screening (n = 1,199). Outreach included processes to promote repeat annual testing for individuals in the FIT outreach group with normal results and completion of diagnostic and screening colonoscopy for those with an abnormal FIT result or assigned to colonoscopy outreach.

The researchers found that screening process completion within three years was 38.4 percent in the colonoscopy outreach group, 28 percent in the FIT outreach group, and 10.7 percent in the usual care group. Compared with the usual care group, between-group differences for completion were higher for both outreach groups, and highest in the colonoscopy outreach group. Compared with usual care, the between-group differences in adenoma and advanced neoplasia detection rates were higher for both outreach groups, and highest in the colonoscopy outreach group.

The authors note that “screening process completion for both outreach groups remained below 40 percent, highlighting the potential for further improvement.”

“These data can help clinicians weigh the pros and cons of different CRC screening strategies in their patient population and practice environment. It is important to consider patients’ barriers to screening initiation when recommending colonoscopy and the need for annual screening or diagnostic colonoscopy when recommending FIT.”

The study notes some limitations, including because it was a pragmatic trial, mailed invitations were simple, 1-page letters and not in-depth decision aids.

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

(doi:10.1001/jama.2017.11389)

In another study, Cedric Rat, M.D., Ph.D., of the Faculty of Medicine, Nantes, France, and colleagues examined whether providing general practitioners (GPs) in France a list of patients who are nonadherent to colorectal cancer (CRC) screening improves patient participation in fecal immunochemical testing (FIT), which is a major challenge in countries that have implemented CRC screening programs. Screenings based on sigmoidoscopy or fecal tests are associated with a decreased 10-year mortality rate.

This study included patients (50-74 years of age) who were at average risk of CRC and not up-to-date with CRC screening. General practitioners were randomly assigned to 1 of 3 groups: 496 received a list of patients who had not undergone CRC screening (patient-specific reminders group, 10,476 patients); 495 received a letter describing region-specific CRC screening adherence rates (generic reminders group, 10,606 patients); and 455 did not receive any reminders (usual care group, 10,147 patients).

The researchers found that at one year, 24.8 percent of patients in the specific reminders group, 21.7 percent in the generic reminders group, and 20.6 percent  in the usual care group participated in the FIT screening.

“Providing GPs with a list of patients who were nonadherent to CRC screening was associated with a modest increase in FIT participation compared with providing GPs with generic reminders about regional CRC screening rates or providing no reminders,” the authors write.

The study notes some limitations, including the small magnitude of the increase in participation (4.2 percent).

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

(doi:10.1001/jama.2017.11387)

Editor’s Note: Please see the articles 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.

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

To place an electronic embedded link to this report in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.11260

Note: A list of related embargoed content appears below.

JAMA

The U.S. Preventive Services Task Force (USPSTF) recommends vision screening at least once in all children 3 to 5 years of age to detect amblyopia (also known as “lazy eye”) or its risk factors (a B recommendation); and concludes that the current evidence is insufficient to assess the balance of benefits and harms of vision screening in children younger than 3 years (an I statement). The report appears in the September 5 issue of JAMA.

A B recommendation indicates that there is high certainty that the net benefit is moderate, or there is moderate certainty that the net benefit is moderate to substantial. An I statement indicates that evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.

One of the most important causes of vision abnormalities in children is amblyopia. Amblyopia is an alteration in the visual neural pathway in a child’s developing brain that can lead to permanent vision loss in the affected eye. Among children younger than 6 years, 1 percent to 6 percent have amblyopia or its risk factors. Early identification of vision abnormalities could prevent the development of amblyopia. To update its 2011 recommendation, the USPSTF reviewed the evidence on the accuracy of vision screening tests and the benefits and harms of vision screening and treatment.

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

Detection

The USPSTF found adequate evidence that vision screening tools are accurate in detecting vision abnormalities, including refractive errors, strabismus (a misalignment of the eyes) and amblyopia, and found inadequate evidence to compare screening accuracy across age groups (younger than 3 vs 3 years and older). Many studies of clinical accuracy did not enroll children younger than 3 years.

Benefits of Early Detection and Treatment

The USPSTF found adequate evidence that treatment of amblyopia or its risk factors in children ages 3 to 5 years leads to improved visual acuity and found inadequate evidence that treatment of amblyopia or its risk factors in children younger than 3 years leads to improved vision outcomes (i.e., visual acuity) or other benefits.

Harms of Early Detection and Treatment

The USPSTF found adequate evidence to assess harms of vision screening tests in children ages 3 to 5 years, including higher false-positive rates in low-prevalence populations. False-positive screening results may lead to overdiagnosis or unnecessary treatment. The USPSTF found adequate evidence to bound the potential harms of vision screening and treatment in children ages 3 to 5 years as small, based on the nature of the interventions, and found inadequate evidence on the harms of treatment in children younger than 3 years.

Summary

The USPSTF concludes with moderate certainty that vision screening to detect amblyopia or its risk factors in children ages 3 to 5 years has a moderate net benefit, and that the benefits of vision screening to detect amblyopia or its risk factors in children younger than 3 years are uncertain, and that the balance of benefits and harms cannot be determined for this age group.

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

(doi:10.1001/jama.2017.11260)

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.

# # #

Related Content from JAMA and the JAMA Network Journals, Available Pre-embargo at the For The Media website:

JAMA

Vision Screening in Children Aged 6 Months to 5 Years

Evidence Report and Systematic Review for the US Preventive Services Task Force

Daniel E. Jonas, M.D., M.P.H., of the University of North Carolina, Chapel Hill, and colleagues

JAMA Ophthalmology

Editorial: The 2017 U.S. Preventive Services Task Force Report on Preschool Vision Screening

Sean P. Donahue, M.D., of the Vanderbilt University Medical Center, Nashville, Tenn.

JAMA Pediatrics

Editorial: Vision Screening in Very Young Children—Making Sense of an Inexorable Diagnostic Process

William V. Good, M.D., Smith-Kettlewell Eye Research Institute, San Francisco

JAMA Patient Page

Vision Screening in Children

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

Media Advisory: To contact Paul L. Delamater, Ph.D., email Kim Weaver Spurr at spurrk@email.unc.edu.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.9242

JAMA

An increase in California in medical exemptions from immunization after elimination of personal belief exemptions suggests that some vaccine-hesitant parents may have located physicians willing to exercise the broader discretion provided by California Senate bill 277 for granting medical exemptions, according to a study published by JAMA.

California Senate bill (SB) 277 eliminated the personal belief exemption (PBE) provision from the state’s school-entry vaccine mandates prior to the 2016-2017 school year. Previously, vaccine-hesitant parents could acquire a PBE for their child based on philosophical or religious beliefs. Now, the only way for an unvaccinated kindergartener to enter a public or private school in California is with a medical exemption (ME), which requires a written statement from a licensed physician describing the medical reasons that immunization is unsafe. Previously, MEs were only granted to children with a contraindication to vaccination; however, SB 277 gave physicians broader discretion to grant MEs for reasons other than a contraindication, including family medical history.

Paul L. Delamater, Ph.D., of the University of North Carolina at Chapel Hill, and colleagues examined the statewide change in MEs in the first year under SB 277 and whether MEs increased in regions with high PBE use prior to its enactment. The researchers used publicly available data from the California Department of Public Health’s yearly Kindergarten Immunization Assessment reports.

In the 20 years prior to SB 277, the percentage of kindergarteners with MEs was largely stable, whereas PBE use increased. In the first year under SB 277, the ME percentage increased from 0.17 percent to 0.51 percent. The PBE percentage decreased from 2.37 percent in 2015 to 0.56 percent in 2016, as PBEs for children who entered multiyear transitional kindergarten programs prior to 2016 remained valid. The total exemption percentage (PBEs + MEs) decreased from 2.54 percent in 2015 to 1.06 percent in 2016.

The authors found a positive relationship between county-level change in ME percentage and previous PBE use, indicating that counties with high PBE use prior to SB 277 had the largest increases in MEs after its implementation.

The study has limitations, including whether MEs were underused prior to 2016 (e.g., children with contraindications having PBEs because they were easier to obtain) is unknown, as are the medical reasons for each ME.

“The increase in the number of MEs granted in 2016 further weakens the immediate effect of SB 277 and may limit its long-term benefits if sustained. Moreover, because the largest increases in ME percentage occurred in regions with high past-PBE use, portions of California may remain susceptible to vaccine-preventable disease outbreaks in the near future. Although this study was limited to a single year of data following the implementation of SB 277, the results warrant attention from both the medical and public health communities,” the researchers write.

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

(doi:10.1001/jama.2017.9242)

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.

EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, AUGUST 22, 2017

Media Advisory: To contact Julie M. Donohue, Ph.D., email Allison Hydzik at hydzikam@upmc.edu.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.7818

JAMA

Despite receiving medical attention for an overdose, patients in Pennsylvania Medicaid continued to have persistently high prescription opioid use, with only slight increases in use of medication-assisted treatment, according to a study published by JAMA.

For every fatal opioid overdose, there are approximately 30 nonfatal overdoses. Nonfatal overdoses that   receive medical attention represent intervention opportunities for clinicians to mitigate risk by reducing opioid prescribing or advocating addiction treatment. Studies evaluating commercially insured patients suggest these potential interventions are underutilized. Julie M. Donohue, Ph.D., of the University of Pittsburgh Graduate School of Public Health, and colleagues used 2008-2013 claims data for all Pennsylvania Medicaid enrollees ages 12 to 64 years with a heroin or prescription opioid overdose to compare prescription opioid use, duration of opioid use, and rates of medication-assisted treatment (MAT; buprenorphine, methadone, or naltrexone) before and after an overdose event.

The analysis included 6,013 patients with an overdose event (2,068 with a heroin overdose and 3,945 with a prescription opioid overdose). The researchers found that any filled opioid prescription decreased after overdose from 43.2 percent to 39.7 percent after heroin overdose, and from 66.1 percent before to 59.6 percent after prescription opioid overdose. The percentage of enrollees with 90 days or more duration of prescription opioids decreased in the heroin group (from 10.5 percent to 9 percent) and the prescription opioid group (from 32.5 percent to 28.3 percent). MAT increased after heroin overdose from 29.5 percent to 33 percent and after prescription opioid overdose from 13.5 percent to 15.1 percent.

The authors write that these findings indicate “a relatively weak health system response to a life-threatening event. Several interventions have been shown to reduce overdose risk, including trigger notifications to clinicians for patients treated for overdose and emergency department-initiated naloxone education and distribution.”

Study limitations include the focus on one state and the use of claims data, which may underestimate opioid use by only tracking prescriptions filled.

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

(doi:10.1001/jama.2017.7818)

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.

EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, AUGUST 22, 2017

Media Advisory: To contact Alastair D. Hay, F.R.C.G.P., email Helen Bolton at helen.bolton@bristol.ac.uk.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.10572

JAMA

Among adults without asthma who developed an acute lower respiratory tract infection, use of the oral steroid prednisolone for five days did not reduce symptom duration or severity, according to a study published by JAMA.

Acute lower respiratory tract infection, defined as an acute cough with at least one of the symptoms of sputum, chest pain, shortness of breath, and wheeze, is one of the most common conditions managed in primary care internationally and is often treated inappropriately with antibiotics. Corticosteroids are increasingly used but without sufficient evidence. Alastair D. Hay, F.R.C.G.P., of the University of Bristol, England and colleagues randomly assigned 401 adults with acute cough and at least one lower respiratory tract symptom not requiring immediate antibiotic treatment and with no history of chronic pulmonary disease or use of asthma medication in the past 5 years to receive two 20-mg prednisolone tablets (n = 199) or matched placebo (n = 202) once daily for 5 days.

Of the patients in the study, 334 provided cough duration and 369 symptom severity data. The researchers found that median cough duration was 5 days in the prednisolone group and 5 days in the placebo group. No significant treatment effects were observed for duration or severity of other acute lower respiratory tract infection symptoms, antibiotic use, or nonserious adverse events. There were no serious adverse events.

The study notes some limitations, including that there was a higher than expected number of participants with zero duration of moderately bad or worse cough, although a sensitivity analysis including these participants did not influence the results.

“These findings do not support oral steroids for treatment of acute lower respiratory tract infection in the absence of asthma,” the authors write.

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

(doi:10.1001/jama.2017.10572)

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.

EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, AUGUST 22, 2017

Media Advisory: To contact Kirsten Bibbins-Domingo, Ph.D., M.D., M.A.S., email Laura Kurtzman at laura.kurtzman@ucsf.edu.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.9924

JAMA

An updated analysis of the low-density lipoprotein cholesterol (LDL-C) lowering drugs, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, finds they are not cost-effective at current prices and that even greater price reductions than previously estimated may be needed to meet cost-effectiveness  thresholds, according to a study published by JAMA.

A cost-effectiveness analysis of PCSK9 inhibitors indicated that their 2015 price would need to be reduced by more than two-thirds (to $4,536 per year) to meet generally accepted cost-effectiveness thresholds. Kirsten Bibbins-Domingo, Ph.D., M.D., M.A.S., of the University of California, San Francisco, and colleagues assessed how the cost-effectiveness of PCSK9 inhibitors is altered by current prices and results of a recent trial (FOURIER), which found that the PCSK9 inhibitor evolocumab reduced the risk of major adverse cardiovascular events (MACE; heart attack, stroke, or cardiovascular death).

The analysis included a simulation group of 8.9 million adults who approximated the FOURIER inclusion criteria (U.S. adults ages 40-80 years with atherosclerotic cardiovascular disease [ASCVD] and LDL-C 70 mg/dL or greater and receiving statin therapy). Drug costs were based on current wholesale acquisition costs ($3,818 for ezetimibe [32 percent increase between 2015 and 2017] and $14,542 for PCSK9 inhibitors [1 percent increase between 2015 and 2017]).

The researchers found that adding PCSK9 inhibitors to statins was estimated to prevent 2,893,500 more MACE compared with adding ezetimibe, although reducing annual drug costs by 71 percent (to $4,215 or less) would be needed for PCSK9 inhibitors to be cost-effective at a threshold of $100,000/quality-adjusted life-year (QALY).

“Although computer simulations that synthesize data from observational studies and clinical trials may not precisely reflect clinical effectiveness that may be observed in practice over time, these updated results continue to demonstrate that reducing the price of PCSK9 inhibitors remains the best approach to delivering the potential health benefits of PCSK9 inhibitors therapy at an acceptable cost,” the authors write.

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

(doi:10.1001/jama.2017.9924)

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.

EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, AUGUST 15, 2017

Media Advisory: To contact Rita F. Redberg, M.D., M.Sc., email Bennett Mcintosh at Bennett.Mcintosh@ucsf.edu.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.9414

JAMA

Among clinical studies used to support FDA approval of high-risk medical device modifications, fewer than half were randomized, blinded, or controlled, according to a study published by JAMA.

High-risk medical devices often undergo modifications, which are approved by the U.S. Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements. Rita F. Redberg, M.D., M.Sc., of the University of California, San Francisco, and colleagues examined the strength of evidence of clinical studies used in FDA-approved panel-track supplements (a type of PMA supplement pathway that is used for significant changes in a device or indication for use and always requires clinical data) between 2006 and 2015.

To determine methodological quality, studies were examined for the use of randomization, blinding, type of controls, clinical vs surrogate primary end points, use of post hoc analyses, and reporting of age and sex. Surrogate was defined as “a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that measures directly how a patient feels, functions or survives.”

The approval of 78 panel-track supplements were supported by 83 clinical studies, with 71 supplements (91 percent) supported by a single study. Of the 83 studies, 45 percent were randomized clinical trials and 30 percent were blinded. The median number of patients per study was 185 and the median follow-up duration was 180 days. Of the primary end points, 121 of 150 (81 percent) were surrogate end points, and 38 percent were compared with controls. Age was not reported in 40 percent of the studies, and 30 percent did not report sex for all enrolled patients.

The authors write that “studies without randomization are prone to various types of bias, making it difficult to ascertain whether these modified devices are safer or more effective than previous iterations, conventional treatments, or no procedure.” And that “for surrogate end points to be useful to patients and clinicians, they must be shown to predict meaningful clinical outcomes, which rarely happens. Therefore, use of surrogate measures can lead to uncertainty about clinical outcomes.”

The study notes some limitations, including that because the focus was premarket clinical data, the analyses did not include preclinical data supporting panel-track supplements or postmarket studies initiated without FDA requirements.

“These findings suggest that the quality of studies and data evaluated to support approval by the FDA of modifications of high-risk devices should be improved,” the researchers write.

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

(doi:10.1001/jama.2017.9414)

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.

EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, AUGUST 15, 2017

Media Advisory: To contact Huseyin Naci, Ph.D., M.H.S., email h.naci@lse.ac.uk.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.9415

JAMA

Among drugs granted accelerated approval by the FDA in 2009-2013, efficacy was often confirmed in subsequent trials a minimum of 3 years after approval, and the use of nonrandomized studies and surrogate measures, instead of clinical outcomes, was common, according to a study published by JAMA.

Drugs treating serious or life-threatening conditions can receive U.S. Food and Drug Administration (FDA) accelerated approval based on showing an effect in surrogate measures, such as biomarkers, laboratory values, or other physical measures, that are only reasonably likely to predict clinical benefit. Confirmatory trials are then required to determine whether these effects translate to clinical improvements.

Huseyin Naci, Ph.D., M.H.S., of the London School of Economics and Political Science, London, and colleagues compared the evidence on qualifying drugs before and after receiving accelerated approval, including the extent to which confirmatory studies were completed and determined whether the drugs demonstrated clinically meaningful benefits. Characteristics of preapproval and confirmatory studies were compared in terms of study design features (randomization, blinding, comparator, primary end point).

The FDA granted accelerated approval to 22 drugs for 24 indications between 2009 and 2013; 14 of the 24 indications for these drugs entered the market on the basis of single-intervention-group studies that enrolled a median of 132 patients, which some investigators would consider a small number. Half of required confirmatory studies were completed a minimum of three years after the approved drug was on the market.

The quality and quantity of postmarketing studies required by the FDA to confirm clinical benefit varied widely across indications. There were few statistically detectable differences in the key design features of trials conducted before and after approval. Nonrandomized studies were common in the accelerated approval pathway both before (60 percent) and after (44 percent) market entry. Even though the majority of completed studies showed positive results in the postmarketing period, all completed confirmatory studies demonstrating drug benefit evaluated surrogate measures of disease activity rather than clinical outcomes. Clinical benefit had not yet been confirmed for eight indications that had been initially approved five or more years prior.

The study notes some limitations, including that the adequacy of the confirmatory studies in addressing questions about the drugs that the FDA considered to be unresolved was not examined because such insights are not available from the FDA documents.

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

(doi:10.1001/jama.2017.9415)

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.

EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, AUGUST 15, 2017

Media Advisory: To contact Mathias Ried-Larsen, Ph.D., email mathias.ried-larsen@regionh.dk.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.10169

JAMA

A high amount and intensity of exercise along with a diet plan resulted in a modest reduction in blood glucose levels among adults with type 2 diabetes, but was accompanied by reductions in the use of glucose-lowering medications, according to a study published by JAMA.

Although medication is effective in lowering hemoglobin A_1c (HbA_1c) in patients with type 2 diabetes, it is also associated with potential adverse drug interactions, discomforts, increased economic costs and decreased quality of life. Lifestyle interventions are needed that are able to maintain glycemic control to at least the same extent as medication.

Mathias Ried-Larsen, Ph.D., with the Copenhagen University Hospital, Rigshospitalet, and colleagues randomly assigned adults with non-insulin-dependent type 2 diabetes who were diagnosed for less than 10 years to a standard care group (n = 34) or a lifestyle group (n = 64). All participants received standard care with individual counseling and standardized, target-driven medical therapy. The lifestyle intervention included five to six weekly aerobic training sessions (duration 30-60 minutes), of which two to three sessions were combined with resistance training. The lifestyle participants received dietary plans aiming for a body mass index of 25 or less. Participants were followed up for 12 months.

From study entry to 12-month follow-up, the average HbA_1c level changed from 6.65 percent to 6.34 percent in the lifestyle group and from 6.74 percent to 6.66 percent in the standard care group (average between-group difference in change of -0.26 percent), not meeting a prespecified criteria for equivalence between groups. Reduction in glucose-lowering medications occurred in 73.5 percent of participants in the lifestyle group and 26.4 percent of participants in the standard care group (difference, 47.1 percentage points).

The study notes some limitations, including that the self-reported dietary intake is subject to biases and limitations.

“Among adults with type 2 diabetes diagnosed for less than 10 years, a lifestyle intervention compared with standard care resulted in a change in glycemic control that did not reach the criterion for equivalence, but was in a direction consistent with benefit. Further research is needed to assess superiority, as well as generalizability and durability of findings,” the authors write.

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

(doi:10.1001/jama.2017.10169)

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.

EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, AUGUST 8, 2017

Media Advisory: To contact Rebecca L. Siegel, M.P.H., email David Sampson at david.sampson@cancer.org.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.7630

JAMA

Colorectal cancer mortality rates have decreased since 1970 in black individuals 20 to 54 years of age, but have increased in white individuals since 1995 among those ages 30 to 39 years and since 2005 among those 40 to 54 years of age following decades of decline, according to a study published by JAMA.

Colorectal cancer (CRC) incidence has been increasing in the United States among adults younger than 55 years since at least the mid-1990s, with the increase mainly among white men and women. Although CRC mortality is declining overall, trends for all ages combined mask patterns in young adults, which have not been comprehensively examined. Rebecca L. Siegel, M.P.H., of the American Cancer Society, Atlanta, and colleagues analyzed CRC mortality among persons ages 20 to 54 years by race from 1970 through 2014.

The researchers found that CRC mortality rates per 100,000 population for this age group declined from 6.3 in 1970 to 3.9 in 2004, then increased by 1 percent annually. The increase was confined to white individuals, among whom mortality rates increased by 1.4 percent annually. Among black individuals, mortality rates declined by 0.4 percent annually to 1.1 percent annually. Among other races combined, mortality rates declined from 1970-2006 and were stable thereafter.

In age-stratified analyses, mortality trends in white individuals during the most recent period were stable for those ages 20 to 29 years from 1988-2014, but increased by 1.6 percent annually for those 30 to 39 years of age from 1995-2014, by 1.9 percent annually for those ages 40 to 49 years, and by 0.9 percent annually for those ages 50 to 54 years from 2005-2014. In contrast, rates in black individuals decreased over the entire study period among those ages 20 to 49 and since 1993 among those ages 50 to 54 years.

The authors note that disparate racial patterns conflict with trends in major CRC risk factors like obesity, which are similar in white and black individuals.

This study is limited by its inaccuracies in about 5 percent of all death certificates listing CRC as the underlying cause of death.

“Escalating mortality rates in young and middle-aged adults highlight the need for earlier CRC detection through age-appropriate screening and more timely follow-up of symptoms,” the researchers write.

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

(doi:10.1001/jama.2017.7630)

Editor’s Note: This work was funded by the American Cancer Society. All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

# # #

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

EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, AUGUST 8, 2017

Media Advisory: To contact Christian Gold, Ph.D., email christian.gold@uni.no.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.9478

JAMA

Among children with autism spectrum disorder, improvisational music therapy resulted in no significant difference in symptom severity compared to children who received enhanced standard care alone, according to a study published by JAMA.

Autism spectrum disorder (ASD) is characterized by persistent deficits in social communication and interaction and restricted, repetitive behaviors and interests. Music therapy seeks to exploit the potential of music as a medium for social communication. In improvisational music therapy, client and therapist spontaneously create music using singing, playing, and movement. It is a developmental, child-centered approach in which a music therapist follows the child’s focus of attention, behaviors, and interests to facilitate development in the child’s social communicative skills.

Christian Gold, Ph.D., of the Grieg Academy Music Therapy Research Centre, Bergen, Norway, and colleagues randomly assigned children ages 4 to 7 years with ASD to enhanced standard care (n = 182) or enhanced standard care plus improvisational music therapy (n = 182). Enhanced standard care consisted of usual care as locally available plus parent counseling to discuss parents’ concerns and provide information about ASD. In improvisational music therapy, trained music therapists sang or played music with each child, attuned and adapted to the child’s focus of attention. The study was conducted in nine countries.

The researchers found that over five months, the amount of improvement in both groups was small, and there was no significant difference in ASD symptom severity based on measures of social affect.

“These findings do not support the use of improvisational music therapy for symptom reduction in children with autism spectrum disorder,” the authors write.

A limitation of the trial was that the duration of the intervention and follow-up, although longer than in previous trials, may have been too short.

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

(doi:10.1001/jama.2017.9478)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, AUGUST 1, 2017

Media Advisory: To contact Hong Zhang, Ph.D., email hongzh@bjmu.edu.cn; to contact Vlado Perkovic, Ph.D., email vperkovic@georgeinstitute.org.au.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.9362

JAMA

Among patients with IgA nephropathy and excess protein in their urine, treatment with pills of the steroid methylprednisolone was associated with an unexpectedly large increase in the risk of serious adverse events, primarily infections, according to a study published by JAMA. IgA nephropathy is a kidney disease that occurs when the antibody immunoglobulin A (IgA) lodges in the kidneys.

Up to 30 percent of all people with IgA nephropathy will eventually develop end-stage kidney disease; decreased kidney function, persistent proteinuria, and hypertension are the strongest risk factors. Guidelines recommend corticosteroids in patients with IgA nephropathy and persistent proteinuria, and they are widely used in these patients, but the benefits and risks have not been clearly established. Hong Zhang, Ph.D., of Peking University First Hospital, Beijing, and Vlado Perkovic, Ph.D., of the George Institute for Global Health, University of New South Wales, Sydney, Australia, and colleagues randomly assigned study participants with IgA nephropathy and proteinuria to oral methylprednisolone (n = 136) or placebo (n = 126) for 2 months, with subsequent weaning over 4 to 6 months.

After 2.1 years’ median follow-up, recruitment was discontinued because of an unexpectedly high rate of serious adverse events (including infections, gastrointestinal, and bone disorders). Serious events occurred in 20 participants (14.7 percent) in the methylprednisolone group vs 4 (3.2 percent) in the placebo group, mostly due to excess serious infections (8.1 percent vs 0), including two deaths. The primary renal outcome (end-stage kidney disease, death due to kidney failure, or a 40 percent decrease in estimated glomerular filtration rate [a measure of substantial loss of kidney function) occurred in 8 participants (5.9 percent) in the methylprednisolone group vs 20 (15.9 percent) in the placebo group.

“Although the results were consistent with potential renal benefit, definitive conclusions about treatment benefit cannot be made, owing to early termination of the trial,” the authors write.

A limitation of the study was that because recruitment was stopped earlier than planned because of excess adverse events, the power of the study was less than predicted, and both risks and benefits might be overestimated as a result.

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

(doi:10.1001/jama.2017.9362)

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

# # #

EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, AUGUST 1, 2017

Media Advisory: To contact Brian C. Drolet, M.D., email Craig Boerner at craig.boerner@vanderbilt.edu.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.7464

JAMA

Although many physicians have objected to high certification fees of the American Board of Medical Specialties member boards, which are nonprofit organizations and have a fiduciary responsibility to match revenue and expenditures, most of these boards had overall revenue that greatly exceeded expenditures in 2013, according to a study published by JAMA.

The process of board certification has a central role in the self-regulation of physician quality standards. However, many physicians have objected to programs by the American Board of Medical Specialties (ABMS), particularly maintenance of certification (MOC), citing a lack of clinical relevance and evidence to support efficacy as well as high fees to participants. Brian C. Drolet, M.D., of Vanderbilt University Medical Center, Nashville, and Vickram J. Tandon, M.D., of the University of Michigan, Ann Arbor, investigated fees charged to physicians for certification examinations and finances of the 24 ABMS member boards

In 2017, the average fee for an initial written examination was $1,846. In addition, 14 boards required an oral examination for initial certification at an average cost of $1,694. Nineteen boards offered subspecialty verification (e.g., hand surgery within orthopedic or plastic surgery) with an average cost of $2,060. Average fees for MOC were $257 annually.

In FY 2013, member boards reported $263 million in revenue and $239 million in expenses; a difference of $24 million in surplus. Examination fees accounted for 88 percent of revenue and 21 percent of expenditures, whereas officer and employee compensation and benefits accounted for 42 percent of expenses. Between 2003 and 2013, the change in net balance (i.e., difference of assets and liabilities) of the ABMS member boards grew from $237 million to $635 million.

This study is limited primarily by the data source, IRS Form 990, which does not contain complete and specific financial accounting for the ABMS member boards.

“Board certification should have value as a meaningful educational and quality improvement process. Although some evidence suggests board certification may improve performance and outcomes, the costs to physicians are substantial. More research is needed to assess the cost-benefit balance and to demonstrate value in board certification,” the authors write.

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

(doi:10.1001/jama.2017.7464)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JULY 25, 2017

Media Advisory: To contact Ann C. McKee, M.D., email Gillian Smith (grsmith@bu.edu) or Pallas Wahl (pallas.wahl@va.gov).

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

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To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.8334

JAMA

Chronic traumatic encephalopathy (CTE) was diagnosed post-mortem in a high proportion of former football players whose brains were donated for research, including 110 of 111 National Football League players, according to a study published by JAMA.

CTE is a progressive neurodegeneration associated with repetitive head trauma and players of American football may be at increased risk of long-term neurological conditions, particularly CTE.

Ann C. McKee, M.D., of the Boston University CTE Center and VA Boston Healthcare System, and colleagues conducted a study that examined the brains of 202 deceased former football players to determine neuropathological features of CTE through laboratory examination and clinical symptoms of CTE by talking to players’ next of kin to collect detailed histories including on head trauma, athletic participation and military service.

Among the 202 football players (median age at death was 66), CTE was neuropathologically diagnosed in 177 players (87 percent) who had had an average of 15 years of football participation. The 177 players included: 3 of 14 high school players (21 percent); 48 of 53 college players (91 percent); 9 of 14 semiprofessional players (64 percent); 7 of 8 Canadian Football League players (88 percent); and 110 of 111 NFL players (99 percent).

Neuropathological severity of CTE was distributed across the highest level of play, with all three former high school players having mild pathology and the majority of former college (56 percent), semiprofessional (56 percent), and professional (86 percent) players having severe pathology. Among 27 participants with mild CTE pathology, 96 percent had behavioral or mood symptoms or both, 85 percent had cognitive symptoms, and 33 percent had signs of dementia. Among 84 participants with severe CTE pathology, 89 percent had behavioral or mood symptoms or both, 95 percent had cognitive symptoms, and 85 percent had signs of dementia.

“In a convenience sample of deceased football players who donated their brains for research, a high proportion had neuropathological evidence of CTE, suggesting that CTE may be related to prior participation in football,” the article concludes. The authors acknowledge several other football-related factors may influence CTE risk and disease severity, including but not limited to age at first exposure to football, duration of play, player position and cumulative hits.

The study has several limitations, including that it is a skewed sample based on a brain donation program because public awareness of a possible link between repetitive head trauma and CTE may have motivated players and their families with symptoms and signs of brain injury to participate in this research. The authors urge caution in interpreting the high frequency of CTE in this study, stressing that estimates of how prevalent CTE may be cannot be concluded or implied.

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

(doi:10.1001/jama.2017.8334)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JULY 25, 2017

Media Advisory: To contact Rachel Y. Moon, M.D., email Joshua Barney at JDB9A@hscmail.mcc.virginia.edu.

Related material: The editorial, “Interventions to Improve Infant Safe Sleep Practices,” by Carrie K. Shapiro-Mendoza, Ph.D., M.P.H., of the U.S. Centers for Disease Control and Prevention. Atlanta, also is available at the For The Media website.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.8982

JAMA

Among mothers of newborns, participation in a mobile health intervention that included receiving frequent educational emails or texts resulted in improved adherence to infant safe sleep practices such as the appropriate sleep position and no soft-bedding use, according to a study published by JAMA.

A national public awareness campaign (Back to Sleep) to improve rates of supine infant sleep positioning to reduce the risk of sudden infant death syndrome (SIDS) was successful in halving the U.S. SIDS rate; however, in 2014 there were still approximately 3,500 infant deaths due to SIDS, accidental suffocation or strangulation in bed, or ill-defined causes. Inadequate adherence to recommendations known to reduce the risk of sudden unexpected infant death has contributed to a slowing in the decline of these deaths.

Rachel Y. Moon, M.D., of the University of Virginia, Charlottesville, and colleagues assessed the effectiveness of two interventions separately and combined to promote infant safe sleep practices compared with control interventions. The study included 1,600 mothers of healthy term newborns who were randomly assigned to four groups: all participants were beneficiaries of a nursing quality improvement (NQI) campaign in infant safe sleep practices (intervention; targeted initial adherence) or breastfeeding (control), and then received a 60-day mobile health program, in which mothers received frequent emails or text messages containing short videos with educational content about infant safe sleep practices (intervention) or breastfeeding (control) and queries about infant care practices.

Of the 1,600 mothers who were randomized, 79 percent completed a study survey (between 2-8 months after study entry). The researchers found that mothers receiving the safe sleep mobile health intervention had higher prevalence of placing their infants supine compared with mothers receiving the control mobile health intervention (89 percent vs 80 percent), room sharing without bed sharing (83 percent vs 70 percent), no soft bedding use (79 percent vs 68 percent), and any pacifier use (69 percent vs 60 percent). The safe sleep NQI intervention alone did not significantly affect any of these outcomes.

A limitation of the study was the lost to follow-up rate of 21 percent.

“Among mothers of healthy term newborns, a mobile health intervention, but not a nursing quality improvement intervention, improved adherence to infant safe sleep practices compared with control interventions. Whether widespread implementation is feasible or if it reduces sudden and unexpected infant death rates remains to be studied,” the authors write.

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

(doi:10.1001/jama.2017.8982)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JULY 25, 2017

Media Advisory: To contact Susanna C. Larsson, Ph.D., email susanna.larsson@ki.se.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.8981

JAMA

A genetic predisposition to higher blood calcium levels was associated with an increased risk of coronary artery disease and heart attack, according to a study published by JAMA.

Calcium has a vital role in many biological processes in the body such as blood clotting. It is unclear whether lifelong elevated serum calcium may be causally associated with coronary artery disease (CAD) risk. Susanna C. Larsson, Ph.D., of the Karolinska Institutet, Stockholm, and colleagues conducted a method of analysis using genetic information known as mendelian randomization to examine the association of serum calcium with CAD and myocardial infarction (MI; heart attack). Mendelian randomization is the use of genetic variants that have a specific influence on possible risk factors to assess associations with explicit outcomes.

The analysis included 184,305 individuals (60,801 CAD cases [approximately 70 percent with MI] and 123,504 noncases) and six genetic variants related to serum calcium levels. The researchers found that a genetic predisposition to higher serum calcium levels was associated with an increased risk of CAD and heart attack.

“Whether the risk of CAD associated with lifelong genetic exposure to increased serum calcium levels can be translated to a risk associated with short-term to medium-term calcium supplementation is unknown,” the authors write.

Several limitations of the study are noted in the article.

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

(doi:10.1001/jama.2017.8981)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JULY 18, 2017

Media Advisory: To contact Frank B. Hu, M.D., Ph.D., email Todd Datz at tdatz@hsph.harvard.edu.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.7092

JAMA

Weight gain from early adulthood (age 18 or 21 years) to age 55 was associated with an increased risk of major chronic diseases, such as type 2 diabetes, hypertension, cardiovascular disease, and death, and a decreased odds of healthy aging, according to a study published by JAMA.

Obesity is a major global health challenge. Among U.S. adults, the average weight gain is 1.1 to 2.2 pounds per year from early to middle adulthood and this modest yearly accumulation of weight eventually leads to obesity over time. It is unclear how weight gain during the transition from early to middle adulthood, when most weight gain occurs, relates to subsequent health consequences.

Frank B. Hu, M.D., Ph.D., of the Harvard T. H. Chan School of Public Health, Boston, and colleagues analyzed data from the Nurses’ Health Study and the Health Professionals Follow-Up Study of participants who recalled weight during early adulthood (at age 18 years in women; 21 years in men), and reported current weight during middle adulthood (at age of 55 years).

A total of 92,837 women (average weight gain, 27.8 pounds over 37 years) and 25,303 men (average weight gain, 21.4 pounds over 34 years) were included in the analysis. Among the findings, weight gain of as little as 11 pounds from early to middle adulthood was associated with a significantly elevated incidence of a composite measure of major chronic diseases, consisting of type 2 diabetes, cardiovascular disease, cancer, and nontraumatic death. Higher amounts of weight gain were associated with greater risks of major chronic diseases and lower likelihood of healthy aging.

A limitation of the study was that weight at early adulthood was recalled at a later age, and some misclassifications of weight change were inevitable.

“These findings may help counsel patients regarding the risks of weight gain,” the authors write.

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

(doi:10.1001/jama.2017.7092)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JULY 18, 2017

Media Advisory: To contact Todd M. Manini, Ph.D., email Rossana Passaniti at passar@shands.ufl.edu.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.7203

JAMA

In older adults with mobility impairments, long-term, moderate-intensity physical activity was associated with a small reduction in total sedentary time, according to a study published by JAMA.

Excessive sedentary time is associated with a number of negative health consequences, especially in older adults, who accumulate the most sedentary time. Although behavioral interventions can increase moderate-intensity activity, the effect on sedentary behaviors remains unclear. Todd M. Manini, Ph.D., and Amal A. Wanigatunga, Ph.D., M.P.H., of the University of Florida, Gainesville, and colleagues analyzed data from the Lifestyle Interventions and Independence for Elders (LIFE) study, which included adults ages 70 to 89 years with mobility impairments randomized to a moderate-intensity physical activity intervention (PA group, with a goal of 150 minutes per week of walking), or a health education program (HE group). Participants were instructed to wear an accelerometer on the hip for 7 consecutive days during waking hours at baseline and 6, 12, and 24 months after randomization. Over 24 months, 1,271 participants had at least one follow-up assessment and 1,164 participants had data collected at the 24-month visit.

The researchers found that at six months, the PA group accumulated less sedentary time than the HE group for sedentary time of 10 minutes or more (475 minutes in the PA group vs 487 minutes in the HE group) and bouts of 30 minutes or more (290 minutes in the PA group vs 299 minutes in the HE group). No intervention differences were detected for bouts of 60 minutes or more of being sedentary. Intervention differences were maintained over 24 months.

“Overall, traditional approaches to increasing moderate-intensity physical activity have little transfer to reductions in total sedentary time and no transfer to prolonged bouts lasting an hour or longer. Additional behavioral approaches are needed to target and reduce sedentary behaviors,” the authors write.

Limitations of the study include the inability to detect posture, napping, behavior types (e.g., television watching), and whether changes in sedentary time were clinically meaningful.

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

(doi:10.1001/jama.2017.7203)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JULY 18, 2017

Media Advisory: To contact Jonathon L. Maguire, M.D., M.Sc., email Leslie Shepherd at ShepherdL@smh.ca.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.8708

JAMA

Among children 1 to 5 years of age, daily high-dose administration of vitamin D did not reduce overall wintertime upper respiratory tract infections, according to a study published by JAMA.

Viral upper respiratory tract infections are the most common infectious illnesses of childhood. Both observational and clinical trial data have suggested a link between low levels of serum 25-hydroxyvitamin D and increased rates of respiratory tract infections. Whether winter supplementation of vitamin D reduces the risk among children is unknown. Jonathon L. Maguire, M.D., M.Sc., of the University of Toronto, and colleagues randomly assigned children ages 1 through 5 years to receive 2,000 IU/d of vitamin D oral supplementation (high-dose group; n=349) or 400 IU/d (standard-dose group; n=354) for a minimum of four months between September and May.

The average number of laboratory-confirmed (based on parent-collected nasal swabs) upper respiratory tract infections per child were 1.05 for the high-dose group and 1.03 for the standard-dose group. There was also no significant difference in the median time to the first laboratory-confirmed infection: 3.95 months for the high-dose group vs 3.29 months for the standard-dose group, or number of parent-reported upper respiratory tract illnesses between groups (625 for high-dose vs 600 for standard-dose groups).

“These findings do not support the routine use of high-dose vitamin D supplementation in children for the prevention of viral upper respiratory tract infections,” the authors write.

A limitation of the study was that children may have had upper respiratory tract infections without swabs being submitted.

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

(doi:10.1001/jama.2017. 8708)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JULY 18, 2017

Media Advisory: To contact Kumar Dharmarajan, M.D., M.B.A., email Ziba Kashef at ziba.kashef@yale.edu.

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JAMA

Although there has been the concern that the reduction in hospital readmission rates may possibly result in an increase in mortality rates after discharge, a new study published by JAMA finds that among Medicare beneficiaries hospitalized for heart failure, heart attack or pneumonia, reductions in hospital 30-day readmission rates were associated with a reduction in 30-day mortality rates following discharge.

The Affordable Care Act (ACA) established the Hospital Readmissions Reduction Program, which required the Centers for Medicare & Medicaid Services to reduce payments to hospitals with higher-than-expected readmission rates for targeted conditions, including heart failure (HF), acute myocardial infarction (AMI; heart attack), and pneumonia. Whether hospitals’ increased focus on lowering readmissions produced unintended consequences, particularly increased mortality after hospitalization, has not been known. Researchers and advocacy groups have raised concerns that hospitals, wary of financial penalties, might deter the readmission of patients requiring inpatient care, thereby increasing mortality after discharge.

Kumar Dharmarajan, M.D., M.B.A., of Yale New Haven Health, New Haven, Conn., and colleagues examined the correlation of trends in hospital 30-day readmission rates and hospital 30-day mortality rates after discharge among Medicare fee-for-service beneficiaries 65 years or older hospitalized with HF, AMI, or pneumonia from January 2008 through December 2014. Approximately 6.7 million hospitalizations for these conditions were identified, as were any changes in risk-adjusted readmission and mortality rates.

Analysis of the data indicated that reductions in hospital 30-day readmission rates were weakly but significantly correlated with reductions in hospital 30-day mortality rates after discharge. “While concerns about unintended consequences of incentivizing readmission reduction have been frequently raised, study findings strongly suggest that mortality has not increased,” the authors write.

A limitation of the study was that because it included only three conditions, findings may not apply to readmission reductions for conditions not targeted by the ACA.

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

(doi:10.1001/jama.2017.8444)

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

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

Media Advisory: To contact Somaia Mohamed, M.D., Ph.D., email Pamela Redmond at Pamela.Redmond@va.gov.

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JAMA

Among patients unresponsive to an antidepressant medication, adding the antipsychotic aripiprazole modestly increased the likelihood of remission from depression compared to switching to the antidepressant bupropion, according to a study published by JAMA.

Major depressive disorder (MDD) is a chronic, debilitating disorder that affected an estimated 16 million adults in the United States in 2015. Less than one-third of patients achieve remission with their first antidepressant. Somaia Mohamed, M.D., Ph.D., of the VA Connecticut Healthcare System, West Haven, Conn., and colleagues randomly assigned 1,522 patients at 35 U.S. Veterans Health Administration medical centers diagnosed with MDD and unresponsive to at least one antidepressant to switch to a different antidepressant (bupropion; n = 511); augment current treatment with bupropion (n = 506); or augment with aripiprazole (n = 505) for 12 weeks (treatment phase) and evaluated for up to 36 weeks.

Among the patients (average age, 54 years; men, 85 percent), 75 percent completed the treatment phase. Depression remission rates at 12 weeks were 22.3 percent for the switch group, 26.9 percent for the augment-bupropion group, and 28.9 percent for the augment­ aripiprazole group. Symptom improvement was greater for the augment-aripiprazole group than for either the switch group or the augment-bupropion group.

Anxiety was more frequent in the two bupropion groups. Adverse effects more frequent in the augment-aripiprazole group included drowsiness, restlessness and weight gain.

“Given the small effect size and adverse effects associated with aripiprazole, further analysis including cost-effectiveness is needed to understand the net utility of this approach,” the authors write.

A limitation of the study was that only one antidepressant and one antipsychotic were evaluated, and the generalizability of the results to other medications is unknown.

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

(doi:10.1001/jama.2017.8036)

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

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

Media Advisory: To contact Mattias Lorentzon, M.D., Ph.D., email mattias.lorentzon@medic.gu.se.

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JAMA

Among older patients using medium to high doses of the anti-inflammatory steroid prednisolone, treatment with the osteoporosis drug alendronate was associated with a significantly lower risk of hip fracture, according to a study published by JAMA.

Although glucocorticoid therapy is widely used to treat inflammatory conditions, it can lead to rapid bone loss and is associated with an increased rate of fracture. Evidence is lacking regarding the efficacy of alendronate to protect against hip fracture in older patients using glucocorticoids. Using a national database, Mattias Lorentzon, M.D., Ph.D., of the University of Gothenburg, Sweden, and colleagues identified 1,802 patients who were prescribed alendronate after at least 3 months of oral prednisolone treatment, and 1,802 patients taking prednisolone without alendronate use.

The average age of the patients was 80 years; 70 percent were women. After a median follow-up of 1.3 years, there were 27 hip fractures in the alendronate group and 73 in the no-alendronate group. Analyses indicated that alendronate treatment for a median duration of 2.9 years was associated with lower risk of hip fracture than no alendronate treatment. Greater duration of treatment was associated with a lower risk of hip fracture.

“Although the findings are limited by the observational study design and the small number of events, these results support the use of alendronate in this patient group,” the authors write.

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

(doi:10.1001/jama.2017.8040)

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

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

To place an electronic embedded link to this report in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.7171

JAMA

The U.S. Preventive Services Task Force (USPSTF) recommends that primary care professionals individualize the decision to offer or refer adults without obesity who do not have high blood pressure, abnormal cholesterol or blood sugar levels or diabetes to behavioral counseling to promote a healthful diet and physical activity. Existing evidence indicates a positive but small benefit of behavioral counseling for the prevention of cardiovascular disease (CVD) in this population. The report appears in the July 11 issue of JAMA.

This is a C recommendation, indicating that the USPSTF recommends selectively offering or providing this service to individual patients based on professional judgment and patient preferences. There is at least moderate certainty that the net benefit is small.

Cardiovascular disease, which includes heart attack and stroke, is the leading cause of death in the United States. Adults who adhere to national guidelines for a healthful diet and physical activity have lower rates of cardiovascular illness and death than those who do not. All persons, regardless of their CVD risk status, can gain health benefits from healthy eating behaviors and appropriate physical activity. To update its 2012 recommendation, the USPSTF reviewed the evidence on whether primary care-relevant counseling interventions to promote a healthful diet, physical activity, or both improve health outcomes, intermediate outcomes associated with CVD, or dietary or physical activity behaviors in adults.

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

Benefits of Behavioral Counseling Interventions

The USPSTF found adequate evidence that behavioral counseling interventions provide at least a small benefit for reduction of CVD risk in adults without obesity who do not have the common risk factors for CVD (hypertension, dyslipidemia, abnormal blood glucose levels, or diabetes). Behavioral counseling interventions have been found to improve healthful behaviors, including beneficial effects on fruit and vegetable consumption, total daily caloric intake, salt intake, and physical activity levels.

Behavioral counseling interventions led to improvements in systolic and diastolic blood pressure levels, low-density lipoprotein cholesterol (LDL-C) levels, body mass index (BMI), and waist circumference that persisted over 6 to 12 months. The USPSTF found inadequate direct evidence that behavioral counseling interventions lead to a reduction in death or CVD rates.

Harms of Behavioral Counseling Interventions

The USPSTF found adequate evidence that the harms of behavioral counseling interventions are small to none. Among 14 trials of behavioral interventions that reported on adverse events, none reported any serious adverse events.

Summary

The USPSTF concludes with moderate certainty that behavioral counseling interventions to promote a healthful diet and physical activity have a small net benefit in adults without obesity who do not have specific common risk factors for CVD. Although the correlation among healthful diet, physical activity, and CVD incidence is strong, existing evidence indicates that the health benefit of behavioral counseling to promote a healthful diet and physical activity among adults without obesity who do not have these specific CVD risk factors is small.

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

(doi:10.1001/jama.2017.7171)

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

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) MONDAY, JULY 3, 2017

Media Advisory: To contact Wendy Lane, M.D., email mountaindiabetes@msn.com. To contact Carol Wysham, M.D., email mediarelations@uw.edu.

To place an electronic embedded link to these studies in your story  These links will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.7115  http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.7117

JAMA

Treatment with the insulin degludec compared to glargine U100 for 32 weeks resulted in a reduced rate of hypoglycemic (low blood sugar) episodes among patients with type 1 or 2 diabetes and at least one risk factor for hypoglycemia, according to two studies published by JAMA.

In one study, Wendy Lane, M.D., of Mountain Diabetes and Endocrine Center, Asheville, N.C., and colleagues randomly assigned 501 adults with type 1 diabetes and at least one hypoglycemia risk factor to receive once-daily insulin degludec followed by insulin glargine U100 (n = 249) or to receive insulin glargine U100 followed by insulin degludec (n = 252) for two 32-week treatment periods. The patients were randomized to morning or evening dosing within each treatment sequence.

Hypoglycemia, common in patients with type 1 diabetes, is a major barrier to achieving good glycemic control. Severe hypoglycemia can lead to coma or death.

Of the patients randomized, 395 (79 percent) completed the trial. The researchers found that insulin degludec compared with insulin glargine U100 resulted in lower rates of overall symptomatic hypoglycemic episodes and nocturnal symptomatic hypoglycemia in the 16-week maintenance period and a lower proportion experienced severe hypoglycemia during the maintenance period (10 percent vs 17 percent). The findings were consistent when analyzed over the full 32-week treatment period.

A limitation of the study, the higher-than-expected withdrawal rate, may have been a result of the demanding nature of the trial, including its 64-week duration, two different treatments, and the use of a vial and syringe.

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

(doi:10.1001/jama.2017.7115)

In another study, Carol Wysham, M.D., of the University of Washington School of Medicine, Spokane, and colleagues randomly assigned 721 adults with type 2 diabetes and at least one hypoglycemia risk factor who were previously treated with basal insulin with or without oral antidiabetic drugs to receive once-daily insulin degludec followed by insulin glargine U100 (n = 361) or to receive insulin glargine U100 followed by insulin degludec (n = 360), and were randomized to morning or evening dosing within each treatment sequence. The trial included two 32-week treatment periods. Hypoglycemia is a serious risk for insulin-treated patients with type 2 diabetes.

Of the randomized patients, 580 (80 percent) completed the trial. The researchers found that treatment with insulin degludec compared with insulin glargine U100 resulted in a statistically significant and clinically meaningful reduction in the rate of overall symptomatic hypoglycemia and nocturnal symptomatic hypoglycemia during the 16-week maintenance period. The hypoglycemia findings were consistent when analyzed over the full treatment period, and they showed a significantly lower rate of severe hypoglycemia with insulin degludec. The proportion of patients experiencing severe hypoglycemia during the maintenance period were 1.6 percent for insulin degludec vs 2.4 percent for insulin glargine U100.

Limitations of the study are noted in the article.

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

(doi:10.1001/jama.2017.7117)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) MONDAY, JULY 3, 2017

Media Advisory: To contact Esther T. Maas, Ph.D., email esther.maas@ubc.ca.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.7918

JAMA

In three randomized trials, treatment of chronic low back pain with radiofrequency denervation, a procedure that can be performed with different techniques including the application of an electric current to the pain-conducting nerve, resulted in either no improvement or no clinically important improvement in chronic low back pain, according to a study published by JAMA.

Low back pain causes more disability than any other condition and has major social and economic consequences. Even though radiofrequency denervation is a commonly used treatment, high-quality evidence for its effectiveness is lacking. Esther T. Maas, Ph.D., of Vrije Universiteit Amsterdam, the Netherlands, and colleagues report the results of three randomized clinical trials that were conducted in 16 pain clinics in the Netherlands. Trial participants, who were unresponsive to conservative care, had chronic low back pain originating in potential sources of the spinal column: the facet joints, sacroiliac joints, or a combination of facet joints, sacroiliac joints, or intervertebral disks.

All participants received a 3-month standardized exercise program and psychological support if needed. Participants in the intervention group received radiofrequency denervation as well, which is usually a 1-time procedure, but the maximum number of treatments in the trial was three.

Among 681 participants who were randomized, 599 (88 percent) completed the 3-month follow-up, and 521 (77 percent) completed the 12-month follow-up. The researchers found that two trials assessing radiofrequency denervation for the sacroiliac joints and a combination of the facet joints, sacroiliac joints, or intervertebral disks showed a statistically significant but not clinically important improvement in pain intensity three months after the intervention. No clinically important or statistically significant differences between the groups were shown in the trial assessing radiofrequency denervation for facet joint pain.

“The findings do not support the use of radiofrequency denervation to treat chronic low back pain from these sources,” the authors write.

A limitation of the study was that because the aim was to provide evidence of the added value of radiofrequency denervation in a multidisciplinary setting, as done in daily practice, participants and clinicians were not blinded.

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

(doi:10.1001/jama.2017.7918)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) MONDAY, JULY 3, 2017

Media Advisory: To contact Nicholas S. Reed, Au.D., email Vanessa McMains at vmcmain1@jhmi.edu.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.6905

JAMA

A comparison between less-expensive, over-the-counter hearing assistance devices and a conventional hearing aid found that some of these devices were associated with improvements in hearing similar to the hearing aid, according to a study published by JAMA.

Presently, hearing aids can only be purchased in the United States through a licensed professional, with an average cost of $4,700 for two hearing aids (uncovered by Medicare).  According to nationally representative estimates, less than 20 percent of adults with hearing loss report hearing aid use. Personal sound amplification products (PSAPs) are less-expensive, over-the-counter devices not specifically labeled for hearing loss treatment, but some are technologically comparable with hearing aids and may be appropriate for mild to moderate hearing loss.

Nicholas S. Reed, Au.D., of the Johns Hopkins School of Medicine, Baltimore, and colleagues compared five of these devices (costs, approximately $350 to $30) with a conventional hearing aid (cost, $1,910) among 42 adults (average age, 72 years) with mild to moderate hearing loss. The researchers found that the change in accuracy in speech understanding from unaided to aided varied by device. Three of the PSAPs were associated with improvements in speech understanding that were similar to results obtained with the hearing aid; one demonstrated little improvement; and speech understanding was worse with one PSAP.

“Results lend support to current national initiatives from the National Academies, White House, and bipartisan legislation requesting that the U.S. Food and Drug Administration create a new regulatory classification for hearing devices meeting appropriate specifications to be available over the counter,” the authors write.

A limitation of the study was the modest number of participants.

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

(doi:10.1001/jama.2017.6905)

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

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

EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 27, 2017

Media Advisory: To contact Linhong Wang, Ph.D., email linhong@chinawch.org.cn; to contact Yonghua Hu, M.D., email yhhu@bjmu.edu.cn.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.7596

JAMA

A large, nationally representative survey in 2013 of adults in China finds that the estimated overall prevalence of diabetes was about 11 percent and that of prediabetes was nearly 36 percent, according to a study published by JAMA.

Previous studies have shown increasing prevalence of diabetes in China, which now has the world’s largest diabetes epidemic. To provide more recent estimates of the prevalence of diabetes and prediabetes, Linhong Wang, Ph.D., of the Chinese Center for Disease Control and Prevention, Beijing, and Yonghua Hu, M.D., of Peking University, Beijing, and colleagues analyzed data from a nationally representative survey conducted in 2013 in mainland China, which included 170,287 participants. Fasting plasma glucose and hemoglobin A_1c levels were measured for all participants. Diabetes and prediabetes were defined according to the 2010 American Diabetes Association criteria.

Among the findings:

• The estimated prevalence of total diagnosed and undiagnosed diabetes was 10.9 percent; that of diagnosed diabetes, 4 percent; and that of prediabetes, 35.7 percent.
• Among persons with diabetes, 36.5 percent were aware of their diagnosis and 32.2 percent were treated; 49.2 percent of patients treated had adequate glycemic control.
• Tibetan and Muslim Chinese had significantly lower prevalence of diabetes than Han participants (14.7 percent for Han, 4.3 percent for Tibetan, and 10.6 percent for Muslim).

The authors write that the prevalence of diabetes of 10.9 percent was only slightly lower than the prevalence of total diabetes in the U.S. population (12-14 percent) in 2011-2012.  The estimated prevalence of prediabetes in China (35.7 percent) was similar to the U.S. (36.5 percent in 2011-2012). Overall, 47 percent of the Chinese adult population was estimated to have either diabetes or prediabetes, slightly lower than the 49 percent to 52 percent estimate in the U.S. population.

With approximately 1.09 billion adults in total in mainland China, it is projected that 388.1 million Chinese adults (200.4 million men and 187.7 million women) may have had prediabetes in 2013.

The authors note that differences from previous higher prevalence estimates for 2010 may be due to an alternate method of measuring hemoglobin A_1c.

A limitation of the study was that the researchers did not distinguish between type 1 and 2 diabetes.

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

(doi:10.1001/jama.2017.7596)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 27, 2017

Media Advisory: To contact Baoyan Liu, M.D., email baoyanjournal@163.com. To contact Xiao-Ke Wu, M.D., Ph.D., email xiaokewu2002@vip.sina.com.

Related material: The editorial, “Acupuncture and the Complex Connections Between the Mind and the Body,” by Josephine P. Briggs, M.D., and David Shurtleff, Ph.D., of the National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, Md., also is available at the For The Media website.

To place an electronic embedded link to these studies in your story  These links will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.7220  http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.7217

JAMA

Electroacupuncture improved stress urinary incontinence –that’s when a woman can experience an involuntary loss of urine such as when sneezing or coughing – but acupuncture did not increase the likelihood of childbirth among women with infertility, according to two studies published by JAMA.

Stress urinary incontinence (SUI) is an involuntary loss of urine on physical exertion, sneezing, or coughing. Electroacupuncture involving the lumbosacral region (near the small of the back and the back part of the pelvis between the hips) may be effective for women with SUI, but evidence is limited. Baoyan Liu, M.D., of the China Academy of Chinese Medical Sciences, Beijing, China, and colleagues randomly assigned 504 women with SUI  to receive 18 sessions (over 6 weeks) of electroacupuncture involving the lumbosacral region (n = 252) or sham electroacupuncture (n = 252) with no skin penetration on sham acupoints. For the electroacupuncture, paired electrodes were attached to needle handles; stimulation lasted for 30 minutes with a continuous wave of 50 Hz and a current intensity of 1 to 5 mA.

Among the randomized participants, 482 completed the study. The researchers found that at week six, the electroacupuncture group had a greater decrease in average urine leakage than the sham electroacupuncture group. The effects persisted 24 weeks after treatment. The incidence of adverse events was low.

“Further research is needed to understand long-term efficacy and the mechanism of action of this intervention,” the authors write.

Limitations of the study are noted in the article.

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

(doi:10.1001/jama.2017.7220)

In another study, Xiao-Ke Wu, M.D., Ph.D., of Heilongjiang University of Chinese Medicine, Harbin, China, and colleagues randomly assigned 1,000 women with polycystic ovary syndrome to active or control acupuncture administered twice a week and clomiphene or placebo administered for five days per cycle, for up to four cycles.

Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility (when the ovaries do not release an egg during a menstrual cycle) and is reported to affect 5 percent to 10 percent of women of reproductive age. Clomiphene citrate is a first-line, inexpensive treatment to induce ovulation in women with PCOS; however, it has had a high failure rate. New treatments are needed for this population. Acupuncture is used to induce ovulation in some women with polycystic ovary syndrome, without supporting clinical evidence.

In this study, the active acupuncture group received deep needle insertion with combined manual and low-frequency electrical stimulation; the control acupuncture group received superficial needle insertion, no manual stimulation, and mock electricity.

Among the women in the study, 250 were randomized to each group; a total of 926 women (93 percent) completed the trial. The researchers found that the live birth rate was significantly higher in the women treated with clomiphene than with placebo (28.7 percent vs 15.4 percent) and not significantly different between women treated with active vs control acupuncture (21.8 percent vs 22.4 percent).

“This finding does not support acupuncture as an infertility treatment in such women,” the authors write.

A limitation of the study was the fixed acupuncture protocol; personalized acupuncture treatment might have been more effective.

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

(doi:10.1001/jama.2017.7217)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 27, 2017

Media Advisory: To contact Michael D. Cusimano, M.D., Ph.D., email Kelly O’Brien at OBrienKel@smh.ca.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.6204

JAMA

In the 2014 soccer World Cup, concussion assessment protocols were not followed in more than 60 percent of plays in which players involved in head collisions were not assessed by sideline health care personnel, according to a study published by JAMA.

The consensus statement from the 2012 and 2016 International Conference on Concussion in Sport, adopted by Federation Internationale de Football Association (FIFA), indicates that players showing any feature of concussion should be immediately withdrawn from play and assessed by sideline health care personnel. Such recommendations and their enforcement may influence officiating, coaching, and play of millions of young players.

To evaluate compliance with the consensus statement, Michael D. Cusimano, M.D., Ph.D., of St. Michael’s Hospital, Toronto, and colleagues examined the incidence, characteristics, and assessment of head collision events during the 2014 FIFA World Cup. Trained reviewers identified head collisions through observation of video footage of all 64 matches of the tournament. Any event involving head contact in which a player did not continue playing immediately afterward was defined as a head collision event. Observable effects of the collision on the player (slow to get up, disoriented, obvious disequilibrium, unconsciousness, seizure-like movements, head clutching) were documented as potential signs of concussion.

During 64 games, 61 players had 81 head collisions in 72 separate events. Health care personnel assessed the player in 12 cases (15 percent); 45 players (56 percent) received assessment from another player, referee, or personnel on the field; and 21 players (26 percent) received no assessment. Of the 67 occasions in which players manifested two or more signs of concussion, 16 percent received no assessment and returned to play immediately. Among players with three or more concussion signs, 86 percent returned to play during the same game after an average assessment duration of 84 seconds.

The researchers note that the estimates from this study could be underestimated because video footage follows the play and some injuries could have been missed.

“Soccer players presenting signs of concussion following a head collision event deserve assessment from independent health care personnel to avoid delay of care or further injury. Assessment and management of soccer players suspected of concussion should be improved,” the authors write.

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

(doi:10.1001/jama.2017.6204)

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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