JAMA

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

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

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

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

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

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.19344)

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

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

JAMA

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

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

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

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

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

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

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

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

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

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

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

Featured Image:

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

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

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

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

• JAMA previously published the interim analysis of this RCT.

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

(doi:10.1001/jama.2017.18718)

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

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JAMA

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.18956

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

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

JAMA

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

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

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

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

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

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

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

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

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

Results:

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

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

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

Featured Image:

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

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

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

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

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

</p>
<div style="position: relative; display: block; max-width: 300px;">
<div style="padding-top: 50%;"><iframe src="//players.brightcove.net/864352215001/default_default/index.html?videoId=5642131093001" allowfullscreen webkitallowfullscreen mozallowfullscreen style="position: absolute; top: 0px; right: 0px; bottom: 0px; left: 0px; width: 100%; height: 100%;"></iframe></div>
</div>
<p>

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

(doi:10.1001/jama.2017.14585)

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

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JAMA

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

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

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

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

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

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

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

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

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

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

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

Related material:

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

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

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

(doi:10.1001/jama.2017.18152)

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

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

JAMA

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

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

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

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

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

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

Related material

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.18261)

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

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

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

JAMA

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

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

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

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

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

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.18249)

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

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

JAMA

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

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

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

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

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

Who and When: Infants born between 2007 and 2013.

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

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

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

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

Featured Image:

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

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

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

Related material:

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

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

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

(doi:10.1001/jama.2017.17627)

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

#  #  #

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

JAMA

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

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

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

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

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

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

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

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

Results:

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

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

Study Limitations: Only approved drugs were analyzed.

Related material

These previous articles from JAMA are also available:

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

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

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

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

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

(doi:10.1001/jama.2017.14896)

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

#  #  #

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

JAMA

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

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

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

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

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

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

What (Study Measures):

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

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

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

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

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

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

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

Related material:

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

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

Previous articles available from JAMA include:

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

Expanded Evidence for Frozen Fecal Microbiota Transplantation for Clostridium difficile Infection

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

Bezlotoxumab (Zinplava) for Prevention of Recurrent Clostridium Difficile Infection

A Patient Page, Fecal Microbiota Transplantation

Diagnosis and Treatment of Clostridium difficile in Adults

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

(doi:10.1001/jama.2017.17077)

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

#  #  #

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

JAMA

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

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

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

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

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

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

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

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

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

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

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

Featured Image:

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

Related material:

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

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

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

(doi:10.1001/jama.2017.17606)

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

#  #  #

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

JAMA

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

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

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

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

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

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

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

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

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

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

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

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

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

Featured Image:

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

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

(doi:10.1001/jama.2017.17070)

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

#  #  #

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

JAMA

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

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

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

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

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

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

When: 2001-2015

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

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

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

Results:

Overall

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

— 5.7 percent annual relative increase in visits after 2008

— Poisoning the most common method of injury

Females

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

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

Males

— Rates of visits stable 2001-2015

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

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

Featured Image:

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

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

(doi:10.1001/jama.2017.13317)

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

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

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

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

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

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JAMA

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

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

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

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

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

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

What (Study Measures):

Exposure: Women’s before-pregnancy body mass index

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

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

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

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

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

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

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

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

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

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

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

Related material:

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

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

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

(doi:10.1001/jama.2017.16191)

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

#  #  #

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

JAMA

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

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

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

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

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

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

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

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

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

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

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

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

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

Related material:

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

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

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<p

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

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

(doi:10.1001/jama.2017.16591)

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

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JAMA

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

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

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

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

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

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

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.11927)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, NOVEMBER 7, 2017

Media advisory: To contact corresponding author Marcel O. Bonn-Miller, Ph.D., email Stephanie Simon at Stephanie.Simon@uphs.upenn.edu. The full study is available on the For The Media website.

Want to embed a link to this study in your story?: Link will be live at the embargo time http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.11909

Bottom Line: Products sold online containing cannabidiol, a chemical compound found in marijuana and thought to have medicinal benefits, often do not contain the amount of cannabidiol indicated on the label.

Why The Research Is Interesting: There is growing consumer demand for cannabidiol. Discrepancies between federal and state cannabis laws have resulted in inadequate regulation and oversight

What, When and How: The accuracy of labels on cannabidiol products sold online (oils, alcohol-based tinctures and vaporization liquid) was tested by sending products bought online to laboratories for content analysis.

Authors: Marcel O. Bonn-Miller, Ph.D., of the University of Pennsylvania Perelman School of Medicine, Philadelphia, and coauthors

Results: 84 products were purchased and analyzed; 43 percent had more cannabidiol than was noted on the product label, 26 percent had less cannabidiol than was noted on the product label, and 31 percent were accurately labeled.

Study Limitations: The products were obtained online only.

Study Conclusions:  A wide range of cannabidiol concentrations was found among cannabidiol products purchased online. The findings highlight the need for manufacturing and testing standards if these products are to be used for medicinal purposes.

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

(doi:10.1001/jama.2017.11909)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, NOVEMBER 7, 2017

Media advisory: To contact corresponding author Joseph L. Dieleman, Ph.D., email Kelly Bienhoff at kbien@uw.edu. The full study is available on the For The Media website.

Want to embed a link to this study in your story? Link will be live at the embargo time http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.15927

Bottom Line: Health care spending increased by more than $900 billion from 1996 to 2013. More than half of the spending increase was attributed to increased prices for health care services, with lesser contributions from growth and aging of the U.S. population.

Why The Research Is Interesting: Spending on health care in the United States is higher than in any other country and is increasing. Total health spending in 2015 reached $3.2 trillion and accounted for nearly 18 percent of the U.S. economy. Understanding what drives spending increases could inform future policy initiatives to help control growth.

What and When: Changes in five factors (population size, population aging, disease prevalence or incidence, service utilization, or service price) related to health care spending (exposure); changes in health care spending in the United States from 1996 to 2013 (outcome).

How (Study Design): Data on the five factors for 155 health conditions and six types of care (ambulatory, inpatient, prescriptions acquired in retail settings, nursing facility, emergency departments and dental care) were collected and analyzed from the Global Burden of Disease 2015 study and the Institute for Health Metrics and Evaluation’s U.S. Disease Expenditure 2013 project.

Authors: Joseph L. Dieleman, Ph.D., of the Institute for Health Metrics and Evaluation, Seattle, and coauthors

Results: After adjustments for price inflation, annual health care spending on the six types of care increased from $1.2 trillion to $2.1 trillion between 1996 and 2013 with contributions as follows:

Study Limitations: Spending estimates were not separated by payer; data on spending and disease were captured only at the national level.

Study Conclusions: Increases in U.S. health care spending from 1996 through 2013 were largely related to increases in prices for health care services but also related to population growth and aging. Understanding the factors that affect spending and how they vary across health conditions and types of care may inform policy efforts to contain health care spending.

Featured Image:

What The Image Shows: Increases in health care service price and per unit (per visit, per day and night in the hospital, per prescription filled) accounted for most of the increase in health care spending from 1996 to 2013.

Related material:

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

• The editorial, “Factors Associated With Increased US Health Care Spending,” by Patrick H. Conway, M.D., M.Sc., Blue Cross Blue Shield of North Carolina, Durham.

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

(doi:10.1001/jama.2017.15927)

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

#  #  #

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

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, NOVEMBER 7, 2017

Media advisory: To contact corresponding author Andrew K. Chang, M.D., M.S., email Sue Ford Rajchel at fords@mail.amc.edu. The full study is available on the For The Media website.

Want to embed a link to this study in your story?: Link will be live at the embargo time http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.16190

Bottom Line: For adults coming to the emergency department for arm or leg pain due to sprain, strain, or fracture, there was no difference in pain reduction after 2 hours with ibuprofen-acetaminophen vs three comparison opioid-acetaminophen (paracetamol) combinations.

Why The Research Is Interesting: The United States is facing an opioid epidemic with almost 500,000 individuals dying from opioid overdoses since 2000. Despite the epidemic, opioid analgesics remain a first-line treatment for moderate to severe acute pain in the emergency department. The combination of ibuprofen and acetaminophen may represent an effective non-opioid alternative.

Who: 416 patients (ages 21 to 64 years) with moderate to severe acute extremity pain in two urban emergency departments were randomly assigned to receive

— 400 mg ibuprofen and 1,000 mg acetaminophen

—  5 mg oxycodone and 325 mg acetaminophen

— 5 mg hydrocodone and 300 mg acetaminophen; or

— 30 mg codeine and 300 mg acetaminophen

When: July 2015 to August 2016

What (Study Measures): The between-group difference in decline in pain two hours after taking the study drugs.

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

Authors: Andrew K. Chang, M.D., M.S., of Albany Medical College, Albany, New York, and coauthors

Results: After 2 hours pain was less in all participants, without any important difference in effect between the four groups.

Study Limitations: The results apply only to pain after two hours. About 1 in 5 patients required additional medication to control their pain.

Study Conclusions: There were no important differences in pain reduction after 2 hours with ibuprofen-acetaminophen or opioid-acetaminophen combination pills in emergency department patients with acute extremity pain. The findings suggest that ibuprofen-acetaminophen is a reasonable alternative to opioid management of acute extremity pain due to sprain, strain, or fracture, but further research to assess longer-term effect, adverse events and dosing is warranted.

Related material:

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

• The editorial, “Opioid vs Nonopioid Acute Pain Management in the Emergency Department,” by Demetrios N. Kyriacou, M.D., Ph.D., Senior Editor, JAMA, Chicago; Northwestern University Feinberg School of Medicine, Chicago.

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

(doi:10.1001/jama.2017.16190)

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, OCTOBER 24, 2017

Media Advisory: To contact corresponding author In Gab Jeong, M.D., Ph.D., email igjeong@amc.seoul.kr. To contact corresponding author David Jayne, M.D., email D.G.Jayne@leeds.ac.uk.

Related material: The editorial, “Robotic-Assisted Surgery,” by Jason D. Wright, M.D., of the Columbia University College of Physicians and Surgeons, New York, 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: first study – http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.14586 2nd study – http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.7219

JAMA

Two studies published by JAMA compare certain outcomes of robotic-assisted vs laparoscopic surgery for kidney removal or rectal cancer.

In one study, In Gab Jeong, M.D., Ph.D., of the Stanford University Medical Center, Stanford, California, and University of Ulsan College of Medicine, Seoul, and colleagues examined the use of robotic-assisted radical nephrectomy (kidney removal) in the United States and compared the in-hospital outcomes and costs between this procedure and laparoscopic radical nephrectomy. The study included patients who had undergone one of these procedures for a renal mass at 416 U.S. hospitals between January 2003 and September 2015. The use of robotic surgery has increased in urological practice over the last decade. However, the use, outcomes, and costs of robotic nephrectomy have not been known.

Among 23,753 patients included in the study, 18,573 underwent laparoscopic radical nephrectomy and 5,180 underwent robotic-assisted radical nephrectomy. Use of robotic-assisted surgery increased from 1.5 percent (39 of 2,676 radical nephrectomy procedures in 2003) to 27 percent (862 of 3,194 radical nephrectomy procedures) in 2015. Compared with laparoscopic radical nephrectomy, robotic-assisted radical nephrectomy was not associated with an increased risk of any or major postoperative complications but was associated with prolonged operating time and higher hospital costs.

Several limitations of the study are noted in the article.

(doi:10.1001/jama.2017.14825)

In another study, David Jayne, M.D., of the University of Leeds, United Kingdom, and colleagues compared robotic-assisted vs conventional laparoscopic surgery for risk of conversion (change due to unforeseen complications that arise during surgery) to open laparotomy (surgical incision through the abdominal wall) among patients undergoing resection (surgical removal) for rectal cancer. Robotic rectal cancer surgery is gaining popularity, but limited data are available regarding safety and efficacy. A concern about robotic surgery is the cost, including the capital and ongoing maintenance charges.

The study, conducted at 29 sites in 10 countries, included patients with rectal cancer who were randomized to robotic-assisted (n = 237) or conventional (n = 234) laparoscopic rectal cancer resection. The overall rate of conversion to open laparotomy was 10.1 percent. The researchers found that there were no statistically significant differences in the rates of conversion to open laparotomy for robotic-assisted laparoscopic surgery compared with conventional laparoscopic surgery (8.1 percent vs 12.2 percent, respectively), and there were no statistically significant differences in complication rates or quality of life at six months.

“These findings suggest that robotic-assisted laparoscopic surgery, when performed by surgeons with varying experience with robotic surgery, does not confer an advantage in rectal cancer resection,” the authors write.

Several limitations of the study are noted in the article.

(doi:10.1001/jama.2017.7219)

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

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, OCTOBER 24, 2017

Media Advisory: To contact corresponding author Paul J. Mills, Ph.D., email Yadira Galindo at ygalindo@ucsd.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.2017.11726

JAMA

Among a sample of older adults living in Southern California, average urine levels of the herbicide glyphosate and its metabolite increased between 1993 and 2016, as did the proportion of samples with detectable levels, according to a study published by JAMA.

Glyphosate, the primary ingredient in a herbicide sprayed onto genetically modified crops, is found in these crops at harvest. Genetically modified crops were introduced in the United States in 1994. Environmental exposure through dietary intake of these crops has potential adverse health effects and can be assessed by measuring urinary excretion.

Paul J. Mills, Ph.D., of the University of California, San Diego, and colleagues measured excretion levels of glyphosate and its metabolite aminomethylphosphonic acid (AMPA) in participants from the Rancho Bernardo Study of Healthy Aging. Among the participants in the study, 112 had routine morning spot urinary biospecimens obtained at each of five clinic visits that took place from 1993 to 1996 and from 2014 to 2016. One hundred of these 112 were randomly selected for this study (average age in 2014-2016 was 78 years; 60 percent were women).

The researchers found that the average glyphosate level increased from 0.024 µg/L in 1993-1996 to 0.314 µg/L in 2014-2016, and reached 0.449 µg/L in 2014-2016 for the 70 participants with levels above the limits of detection (LOD). Average AMPA levels increased from 0.008 µg/L in 1993-1996 to 0.285 µg/L in 2014-2016, and reached 0.401 µg/L in 2014-2016 for the 71 participants with levels above the LOD. The prevalence rates of glyphosate samples above the LOD increased significantly over time, from 0.120 in 1993-1996 to 0.700 in 2014-2016. The prevalence of AMPA samples above the LOD increased significantly from 0.050 in 1993-1996 to 0.710 in 2014-2016.

The authors write that animal and human studies suggest that chronic exposure to glyphosate-based herbicides can induce adverse health outcomes. In July 2017, in accordance with the Safe Drinking Water and Toxic Enforcement Act of 1986, the state of California listed glyphosate as a probable carcinogen. “Future studies of the relationships between chronic glyphosate exposure and human health are needed.”

The article notes some limitations, including that the study group lived in Southern California, which might have different exposures than other states.

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

(doi:10.1001/jama.2017.11726)

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, OCTOBER 24, 2017

Media Advisory: To contact corresponding author Stacy A. Shackelford, M.D., email william.blankenship.5@us.af.mil.

Related material: The editorial, “Prehospital Blood Transfusion for Combat Casualties,” by Eric A. Elster, M.D., and Jeffrey Bailey, M.D., of the Uniformed Services University of the Health Sciences, Bethesda, Maryland, also is available at the For The Media website.

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JAMA

Among medically evacuated U.S. military combat causalities in Afghanistan, blood product transfusion within minutes of injury or prior to hospitalization was associated with greater 24-hour and 30-day survival than delayed or no transfusion, according to a study published by JAMA.

Hemorrhage is a leading cause of preventable death in both military and civilian trauma care. Even though it is intuitive that early transfusion for hemorrhagic shock should improve survival, published data on prehospital transfusion to date has not demonstrated a survival advantage.

Stacy A. Shackelford, M.D., of Ft. Sam Houston, San Antonio, and colleagues examined the association of prehospital transfusion and time to initial transfusion with injury survival. The study included U.S. military combat casualties in Afghanistan between April 2012 and August 7, 2015. Eligible patients were rescued alive by medical evacuation (MEDEVAC) from point of injury with either (1) a traumatic limb amputation at or above the knee or elbow or (2) shock defined as a systolic blood pressure of less than 90 mm Hg or a heart rate greater than 120 beats per minute.

For the 386 patients without missing data among the 400 patients within the matched groups, prehospital transfusion was associated with a 74 percent lower risk of death over 24 hours, and a 61 percent lower risk of death over 30 days. Time to initial transfusion, regardless of location (prehospital or during hospitalization), was associated with reduced 24-hour mortality only up to 15 minutes after MEDEVAC rescue (median, 36 minutes after injury).

“The findings support prehospital transfusion in this setting,” 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.2017.15097)

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, OCTOBER 17, 2017

Media Advisory: To contact corresponding author Rutger A. Middelburg, Ph.D., email r.a.middelburg@lumc.nl.

Related material: The editorial, “Blood Transfusions From Previously Pregnant Women and Mortality,” by Ritchard G. Cable, M.D., of the American Red Cross Blood Services, Connecticut Region, Farmington, and Gustaf Edgren, M.D., Ph.D., of the Karolinska lnstitutet, Stockholm, Sweden, also is available at the For The Media website.

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JAMA

Among patients who received red blood cell transfusions, receiving a transfusion from a donor who was ever pregnant, compared with a male donor, was associated with an increased risk of death among male recipients of transfusions but not among female recipients, according to a study published by JAMA.

The most common cause of transfusion-related mortality is transfusion-related acute lung injury (TRALI), which has also been shown to be associated with transfusions from female donors. Furthermore, TRALI is associated specifically with transfusions from female donors with a history of pregnancy. Rutger A. Middelburg, Ph.D., of Sanquin Research, Leiden, the Netherlands, and colleagues conducted a study of first-time transfusion recipients at six major Dutch hospitals to quantify the association between red blood cell transfusion from female donors with and without a history of pregnancy and mortality of red blood cell recipients.

The group for the primary analyses consisted of 31,118 patients who received 59,320 red blood cell transfusions from 1 of 3 types of donors (88 percent male; 6 percent ever-pregnant female; and 6 percent never-pregnant female). The number of deaths in this group was 3,969 (13 percent mortality). For male recipients of red blood cell transfusions, all-cause mortality rates after a red blood cell transfusion from an ever-pregnant female donor vs male donor were 101 vs 80 deaths per 1,000 person-years. For receipt of transfusion from a never-pregnant female donor vs male donor, mortality rates were 78 vs 80 deaths per 1,000 person-years. Among female recipients of red blood cell transfusions, mortality rates for an ever-pregnant female donor vs male donor were 74 vs 62 per 1,000 person-years.

Several limitations of the study are noted in the article.

“Further research is needed to replicate these findings, determine their clinical significance, and identify the underlying mechanism,” the authors write.

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

(doi:10.1001/jama.2017.14825)

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, OCTOBER 17, 2017

Media Advisory: To contact corresponding author Melanie Davies, M.D., email melanie.davies@uhl-tr.nhs.uk.

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JAMA

Among patients with type 2 diabetes, the drug semaglutide taken by pill resulted in better glycemic control than placebo over 26 weeks, findings that support phase 3 studies to assess longer-term and clinical outcomes, as well as safety, according to a study published by JAMA.

Although several type 2 diabetes treatments are available, therapy selection involves consideration of the risks of adverse effects such as hypoglycemia (low blood sugar) or weight gain and complexity of treatment. The oral formulation of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonists (a class of drugs used for the treatment of type 2 diabetes) may improve acceptance and adherence for some patients compared with the injectable formulation of GLP-1 receptor agonists. In a phase 2 trial, Melanie Davies, M.D., of the University of Leicester, United Kingdom, and colleagues randomly assigned 632 patients with type 2 diabetes and insufficient glycemic control to different doses and dose escalation of once-daily oral semaglutide; oral placebo; or once-weekly semaglutide by injection (subcutaneous) for 26 weeks.

The researchers found that average change in hemoglobin A_lc (HbA_1c) level from baseline to week 26 decreased with oral semaglutide (dosage-dependent range, -0.7 percent to -1.9 percent) and subcutaneous semaglutide (-1.9 percent) and placebo (-0.3 percent); oral semaglutide reductions were significant vs placebo. From an average baseline HbA_1c level of 7.9 percent, between 44 percent (2.5-mg group) and 90 percent (40-mg standard escalation group) of patients receiving oral semaglutide achieved the target HbA_1c level of less than 7 percent. Clinically relevant (5 percent or more) weight loss was achieved in up to 71 percent of patients receiving oral semaglutide. The adverse event profile of oral semaglutide was comparable with subcutaneous semaglutide.

Several limitations of the study are noted in the article, including duration.

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(doi:10.1001/jama.2017.14752)

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, OCTOBER 17, 2017

Media Advisory: To contact corresponding author Emilio Dirlikov, Ph.D., email KLT9@cdc.gov.

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JAMA

An examination of cases of Guillain-Barré syndrome in Puerto Rico identified Zika virus infection as a risk factor, according to a study published by JAMA.

Guillain-Barré syndrome (GBS) is an uncommon autoimmune disorder characterized by progressive weakness and diminished deep tendon reflexes following infection or, rarely, vaccination. Increased GBS incidence has been reported in countries affected by Zika virus. Emilio Dirlikov, Ph.D., of the Centers for Disease Control and Prevention, San Juan, Puerto Rico, and colleagues examined risk factors associated with GBS during the Zika virus epidemic in Puerto Rico.

The study included 39 patients with a confirmed GBS neurologic diagnosis. Comparing case-patients and controls, identified GBS risk factors were acute illness within the previous 2 months (82 percent for case-patients vs 22 percent for controls), including multiple symptoms; acute Zika virus infection (23 percent case-patients vs 4 percent controls); and any laboratory evidence of Zika virus infection (69 percent case-patients vs 24 percent controls). No other behaviors, exposures, or medical history variables were identified as risk factors.

A limitation of the study was its small sample size.

“The pathophysiology of Zika virus infection and risk factors for developing GBS require further investigation. Clinical trials of the Zika virus vaccine should monitor for GBS. During Zika virus outbreaks, clinical suspicion should be elevated to improve GBS patient prognosis through prompt diagnosis and treatment,” the authors write.

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

(doi:10.1001/jama.2017.11483)

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EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, OCTOBER 10, 2017

Media Advisory: To contact corresponding author Beate Karges, M.D., email bkarges@ukaachen.de.

To place an electronic embedded link in your story: Link will be live at the embargo time http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.13994

JAMA

Compared with insulin injections, insulin pump therapy among young patients with type 1 diabetes was associated with a lower risk of diabetic ketoacidosis and severe hypoglycemia, according to a study published by JAMA.

The use of insulin pumps for intensive insulin therapy among patients with type l diabetes has increased substantially in recent years. Several studies have reported an increased risk of ketoacidosis (a serious diabetes complication where the body produces excess blood acids) associated with insulin pump therapy in pediatric patients with diabetes. Beate Karges, M.D., of RWTH Aachen University, Germany, and colleagues conducted a study that included patients with type 1 diabetes younger than 20 years and diabetes duration of more than one year who were treated with insulin pump therapy or with multiple (four or more) daily insulin injections.

Of 30,579 patients (average age, 14 years), 14,119 used pump therapy and 16,460 used insulin injections. Pump therapy, compared with injection therapy, was associated with lower rates of severe hypoglycemia (9.55 vs 13.97 per 100 patient-years) and diabetic ketoacidosis (3.64 vs 4.26 per 100 patient-years). Glycated hemoglobin levels and total daily insulin doses were lower with pump therapy than with injection therapy.

“These findings provide evidence for improved clinical outcomes associated with insulin pump therapy compared with injection therapy in children, adolescents, and young adults with type 1 diabetes,” 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.2017.13994)

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EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, OCTOBER 10, 2017

Media Advisory: To contact corresponding author Anne Z. Steiner, M.D., M.P.H., email Courtney Mitchell at Courtney.Mitchell@unchealth.unc.edu.

Related material: The editorial, “Using Antimullerian Hormone to Predict Fertility,” by Nanette Santoro, M.D., of the University of Colorado School of Medicine, Aurora, also is available at the For The Media website.

To place an electronic embedded link in your story: Link will be live at the embargo time http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.14588

JAMA

Among women of older reproductive age attempting to conceive naturally, biomarkers indicating diminished ovarian reserve compared with normal ovarian reserve were not associated with reduced fertility, according to a study published by JAMA.

Despite lack of evidence of their utility, biomarkers of ovarian reserve are being promoted as potential markers of reproductive potential. Anne Z. Steiner, M.D., M.P.H., of the University of North Carolina, Chapel Hill, and colleagues conducted a study to determine the extent to which biomarkers of ovarian reserve (early-follicular-phase serum antimullerian hormone [AMH], serum follicle-stimulating hormone [FSH], serum inhibin B, and urinary FSH) were associated with reproductive potential. The study included women ages 30 to 44 years without a history of infertility who had been trying to conceive for three months or less.

A total of 750 women provided a blood and urine sample and were included in the analysis. After adjusting for various factors, the researchers found that low AMH or high FSH (biomarkers of diminished ovarian reserve) were not associated with reduced fecundability (probability of conception in a given menstrual cycle) or a lower cumulative probability of conceiving by 6 or 12 cycles of pregnancy attempt. Early-follicular-phase inhibin B levels were also not associated with fertility outcomes.

Several limitations of the study are noted in the article.

“Among women aged 30 to 44 years without a history of infertility who had been trying to conceive for 3 months or less, biomarkers indicating diminished ovarian reserve compared with normal ovarian reserve were not associated with reduced fertility. These findings do not support the use of urinary or blood follicle-stimulating hormone tests or antimullerian hormone levels to assess natural fertility for women with these characteristics,” the authors write.

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

(doi:10.1001/jama.2017.14588)

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EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, OCTOBER 10, 2017

Media Advisory: To contact corresponding author Jason N. Doctor, Ph.D., email Emily Gersema at gersema@usc.edu.

To place an electronic embedded link in your story: Link will be live at the embargo time http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.11152

JAMA

In the 12 months after removing behavioral interventions, inappropriate antibiotic prescribing for acute respiratory infections increased relative to control practices, according to a study published by JAMA.

Inappropriate antibiotic prescribing contributes to antibiotic resistance and leads to adverse events. A randomized trial of three behavioral interventions intended to reduce inappropriate prescribing found that 2 of the 3 interventions were effective. Jason N. Doctor, Ph.D., of the University of Southern California, Los Angeles, examined the persistence of effects 12 months after stopping the interventions. The researchers randomized 47 primary care practices in Boston and Los Angeles and enrolled 248 clinicians to receive 0, 1, 2, or 3 interventions for 18 months. All clinicians received education on antibiotic prescribing guidelines.

The authors found that during the postintervention period, the rate of inappropriate antibiotic prescribing decreased in control clinics from 14.2 percent to 11.8 percent, and for the different types of interventions, it increased from 7.4 percent to 8.8 percent for suggested alternatives; increased from 6.1 percent to 10.2 percent for accountable justification; and increased from 4.8 percent to 6.3 percent for peer comparison. During the postintervention period, peer comparison remained lower than control, whereas accountable justification was not different from control.

Limitations of the study are that it only included volunteering clinicians from selected practices, and the postintervention follow-up was only 12 months.

“These findings suggest that institutions exploring behavioral interventions to influence clinician decision-making should consider applying them long-term,” the authors write.

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

(doi:10.1001/jama.2017.11152)

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, OCTOBER 3, 2017

Media Advisory: To contact Nakia S. Clemmons, M.P.H., email Ian Branam at yfi1@cdc.gov.

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JAMA

From 2001 to 2015, the overall annual incidence of measles in the United States remained extremely low (less than 1 case/million population) compared with incidence worldwide (40 cases/million population); relative increases in measles rates were observed over the period, and the findings suggest that failure to vaccinate may be the main driver of measles transmission, according to a study published by JAMA.

Through nationwide use of vaccination, endemic measles (i.e., a transmission chain lasting 12 months or longer) was eliminated in the United States in 2000. Yet, importations of measles from endemic countries continue to occur, leading to outbreaks. Using data from the U.S. Centers for Disease Control and Prevention, Nakia S. Clemmons, M.P.H., of the CDC, Atlanta, and colleagues examined the incidence of measles among U.S. residents and trends after elimination.

From 2001 through 2015, 1,789 measles cases were reported among U.S. residents (median age, 15 years; female, 47 percent). Most were unvaccinated (69.5 percent) or had unknown vaccination status (17.7 percent); in those 30 years or older, 48.1 percent had unknown vaccination status. Measles incidence was 0.39 per million population.

Incidence per million population was highest in infants ages 6 to 11 months and toddlers ages 12 to 15 months. Measles rates declined with age beginning at 16 months. The annual number of measles cases varied between 24 and 658, and incidence per million population varied between 0.08 and 2.06. Higher incidence per million population was noted over time, from 0.28 in 2001 to 0.56 in 2015. The proportion of cases that were imported and vaccinated also varied by year but decreasing trends were observed. Vaccinated patients ranged between 5.5 percent and 29.6 percent of U.S. cases and decreased from 29.6 percent in 2001 to 20.2 percent in 2015.

Limitations of the study include lack of verifiable immunization on 48 percent of adults and the possibility of reporting changes, although sustained surveillance adequacy has been documented.

“The declining incidence with age, the high proportion of unvaccinated cases, and the decline in the proportion of vaccinated cases despite rate increases suggest that failure to vaccinate, rather than failure of vaccine performance, may be the main driver of measles transmission, emphasizing the importance of maintaining high vaccine coverage,” the authors write.

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

(doi:10.1001/jama.2017.9984)

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, OCTOBER 3, 2017

Media Advisory: To contact Chang-Fu Kuo, M.D., Ph.D., email zandis@gmail.com.

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JAMA

Among patients with nonvalvular atrial fibrillation, concurrent use of certain commonly prescribed medications with non-vitamin K oral anticoagulants was associated with an increased risk of major bleeding, according to a study published by JAMA.

Oral anticoagulation has been proven to prevent ischemic strokes and prolong life for patients with atrial fibrillation. Non-vitamin K oral anticoagulants (NOACs) are being used more frequently because of their ease of administration and comparative efficacy compared with warfarin in reducing blood clots and major bleeding. However, for patients with atrial fibrillation, NOACs are often prescribed with other medications that share metabolic pathways that may increase major bleeding risk.

Chang-Fu Kuo, M.D., Ph.D., of Chang Gung Memorial Hospital, Taoyuan, Taiwan, and colleagues used data from the Taiwan National Health Insurance database and included 91,330 patients with nonvalvular atrial fibrillation who received at least one NOAC prescription of dabigatran, rivaroxaban, or apixaban and estimated the bleeding risk associated with or without the concurrent use of 12 commonly prescribed medications that share metabolic pathways with NOACs (atorvastatin; digoxin; verapamil; diltiazem; amiodarone; fluconazole; ketoconazole, itraconazole, voriconazole, or posaconazole; cyclosporine; erythromycin or clarithromycin; dronedarone; rifampin; or phenytoin).

Among the patients in the study, 4,770 major bleeding events occurred. The researchers found that concurrent use of amiodarone, fluconazole, rifampin, and phenytoin with NOACs had a significant increase in incidence rates of major bleeding than NOACs alone. Compared with NOAC use alone, the incidence rate for major bleeding was significantly lower for concurrent use of atorvastatin, digoxin, and erythromycin or clarithromycin and was not significantly different for concurrent use of verapamil; diltiazem; cyclosporine; ketoconazole, itraconazole, voriconazole, or posaconazole; and dronedarone.

The study notes some limitations, including that bleeding risk and anticoagulant treatment in the Asian population have been recognized to be different from the Western population. Therefore, the external generalizability of these results, particularly to a Western population may be limited.

“Physicians prescribing NOAC medications should consider the potential risks associated with concomitant use of other drugs,” the authors write.

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(doi:10.1001/jama.2017.13883)

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, OCTOBER 3, 2017

Media Advisory: To contact Robert K. Nam, M.D., M.Sc., email Alexis Dobranowski at Alexis.dobranowski@sunnybrook.ca.

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JAMA

Use of blood-thinning medications among older adults was significantly associated with higher rates of hematuria (the presence of blood in urine)-related complications, including emergency department visits, hospitalizations and urologic procedures to manage visible hematuria, according to a study published by JAMA.

Antithrombotic (reduces the formation of blood clots) medications, such as warfarin and aspirin, are among the most commonly prescribed and also among the medications most commonly associated with adverse events. While hematuria represents a less life-threatening adverse event than intracranial or gastrointestinal bleeding, it is common and involves diagnostic evaluation including abdominal imaging and invasive testing and management. The prevalence, severity, and risk factors for hematuria associated with the use of anti-thrombotic agents are largely unknown.

Robert K. Nam, M.D., M.Sc., of Sunnybrook Health Sciences Centre, University of Toronto, and colleagues conducted a study that included citizens of Ontario, Canada, ages 66 years and older, and examined rates of hematuria-related complications among patients taking antithrombotic medications.

Among 2,518,064 patients, 808,897 (average age, 72 years) received at least one prescription for an antithrombotic agent over the study period (2002-2014). Over a median follow-up of 7.3 years, the rates of hematuria-related complications (defined as emergency department visit, hospitalization, or a urologic procedure to investigate or manage gross hematuria [blood in the urine that can be seen with the naked eye]) were 124 events per 1,000 person-years among patients actively exposed to antithrombotic agents vs 80 events among patients not exposed to these drugs.

While there was variation between medications, this association was present for all medications examined. Readily identifiable factors, including patient age, male sex, comorbidity, and preexistent urologic disease, were significantly associated with rates of gross hematuria.

The study notes some limitations, including that owing to funding eligibility for prescription medications in Ontario, the cohort was restricted to patients ages 66 years and older. Given the interaction between age and the association of antithrombotic therapies with hematuria-related  complications, these results are not directly applicable to younger patients.

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

(doi:10.1001/jama.2017.13890)

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EMBARGOED FOR RELEASE: 12 P.M. (ET) MONDAY, OCTOBER 2, 2017

Media Advisory: To contact Robert A. Fowler, M.D.C.M., M.S.(Epi), email media.relations@utoronto.ca.

Related material: The editorial, “End-of-Life Care Among Immigrants – Disparities or Differences in Preferences?” by Michael O. Harhay, Ph.D., and Scott D. Halpern, M.D., Ph.D., of the University of Pennsylvania Perelman School of Medicine, Philadelphia, also is available at the For The Media website.

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JAMA

Among deceased in Ontario, Canada, recent immigrants were significantly more likely to receive aggressive care and to die in an intensive care unit compared with other residents, according to a study published by JAMA. The study is being released to coincide with its presentation at the Critical Care Canada Forum.

Preliminary evidence suggests that some immigrants may face cultural and logistical challenges in end-of-life care due to several factors, including decreased health literacy or language ability and decreased access to care due to insufficient financial and social resources. Some immigrants may have different end­ of-life care preferences than many long-standing residents. Robert A. Fowler, M.D.C.M., M.S.(Epi), of the University of Toronto, Canada, and colleagues examined end-of-life care provided to immigrants to Canada in the last six months of their life. All decedents who immigrated to Canada between 1985 and 2015 were classified as recent immigrants.

The study included 967,013 decedents in Ontario, Canada, of whom 5 percent immigrated since 1985; long-standing residents were older than immigrant decedents (median age, 75 vs 80 years). Recent immigrant decedents were overall more likely to die in intensive care (16 percent vs 10 percent). In their last six months of life, recent immigrant decedents experienced more intensive care admissions (25 percent vs 19 percent), hospital admissions (72 percent vs 68 percent), mechanical ventilation (22 percent vs 14 percent), dialysis (5.5 percent vs 3.4 percent), percutaneous feeding tube placement (5.5 percent vs 3 percent), and tracheostomy (2.3 percent vs 1.1 percent).

Increased rates of aggressive care varied substantially according to region of birth. For example, compared with long-standing residents, recent immigrants born in Northern and Western Europe were less likely to die in intensive care; those born in South Asia were nearly twice as likely to die in intensive care. Increased rates of aggressive care were not explained by differences in age, sex or socioeconomic position.

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.2017.14418)

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

Media Advisory: To contact Brian F. Gage, M.D., M.Sc., email Diane Williams at williamsdia@wustl.edu.

Related material: The editorial, “Pharmacogenomic Testing and Warfarin,” by Jon D. Emery, M.B.B.Ch., of the University of Melbourne, Australia, 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.2017.11463

JAMA

Among patients undergoing hip or knee replacement and treated with the blood thinner warfarin, customizing dosing to a patient’s genetic and clinical profile resulted in the prevention of more adverse outcomes than clinically-guided dosing, according to a study published by JAMA.

For at least the last 10 years, warfarin use has accounted for more medication-related emergency department visits among older patients than any other drug. Warfarin dose requirements vary widely among individuals because of common genetic variants.  Because knowledge of a patient’s genotype should lead to more accurate warfarin initiation and a reduction in adverse events, the product label for warfarin (Coumadin and others) has encouraged genotype-guided dosing since 2007. However, multicenter studies of genotype-guided dosing of oral vitamin K antagonists have had mixed results. Thus, it was unclear whether genotype-guided dosing could improve the safety of warfarin initiation.

Brian F. Gage, M.D., M.Sc., of Washington University in St. Louis, and colleagues randomly assigned patients ages 65 years or older initiating warfarin for elective hip or knee replacement to genotype-guided or clinically-guided warfarin dosing on days 1 through 11 of therapy and to a target international normalized ratio (INR) of either 1.8 or 2.5. Patients were genotyped for certain genetic variants.

Among 1,650 randomized patients, 97 percent received at least 1 dose of warfarin therapy and completed the trial (n = 808 in genotype-guided group vs n = 789 in clinically-guided group). A total of 87 patients (10.8 percent) in the genotype-guided group vs 116 patients (14.7 percent) in the clinically guided warfarin dosing group met at least one of the end points (major bleeding, INR of 4 or greater, venous thromboembolism or death). The numbers of individual events in the genotype-guided group vs the clinically guided group were 2 vs 8 for major bleeding, 56 vs 77 for INR of 4 or greater, and 33 vs 38 for venous thromboembolism; there were no deaths.

The study notes some limitations, including that the benefits of genotype-guided dosing may differ when applied to patients of other ages or to general clinical practice.

“Further research is needed to determine the cost-effectiveness of personalized warfarin dosing,” the authors write.

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

(doi:10.1001/jama.2017.11463)

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

Media Advisory: To contact Christopher J. L. Murray, M.D., D.Phil., email Kelly Bienhoff (kbien@uw.edu) or Dean Owen (dean1227@uw.edu).

Related material: The editorial, “Using Big Data to Reveal Chronic Respiratory Disease Mortality Patterns and Identify Potential Public Health Interventions,” by David M. Mannino, M.D., and Wayne T. Sanderson, Ph.D., of the University of Kentucky College of Public Health, Lexington, 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.2017.11747

JAMA

Between 1980 and 2014, the rate of death from chronic respiratory diseases, such as COPD, increased by nearly 30 percent overall in the U.S., although this trend varied by county, sex, and chronic respiratory disease type, according to a study published by JAMA.

Chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD) and asthma, are responsible for a substantial health and financial burden in the United States each year. In 2015, 6.7 percent of all deaths were due to chronic respiratory diseases, which were the fifth leading cause of death. Geographically precise annual estimates of chronic respiratory disease mortality by type would allow a more complete understanding of regional variation in chronic respiratory disease mortality rates and may be useful for clinicians and policy makers interested in reducing geographic disparities and the health and financial burdens of chronic respiratory diseases overall.

Christopher J. L. Murray, M.D., D.Phil., of the Institute for Health Metrics and Evaluation, University of Washington, Seattle, and colleagues used death records from the National Center for Health Statistics and population counts from the U.S. Census Bureau, National Center for Health Statistics, and Human Mortality Database to estimate county-level mortality rates from 1980 to 2014 for chronic respiratory diseases.

A total of 4,616,711 deaths due to chronic respiratory diseases were recorded in the United States from January 1980 through December 2014. Nationally, the mortality rate from chronic respiratory diseases increased from 40.8 deaths per 100,000 population in 1980 to a peak of 55.4 in 2002 and then declined to 52.9 deaths per 100,000 population in 2014. This overall 29.7 percent increase in chronic respiratory disease mortality from 1980 to 2014 reflected increases in the mortality rate from chronic obstructive pulmonary disease (by 30.8 percent), interstitial lung disease and pulmonary sarcoidosis (by 100.5 percent), and all other chronic respiratory diseases (by 42.3 percent).

There were substantial differences in mortality rates and changes in mortality rates over time among counties, and geographic patterns differed by cause. Counties with the highest mortality rates were found primarily in central Appalachia for chronic obstructive pulmonary disease and pneumoconiosis; widely dispersed throughout the Southwest, northern Great Plains, New England, and South Atlantic for interstitial lung disease; along the southern half of the Mississippi River and in Georgia and South Carolina for asthma; and in southern states from Mississippi to South Carolina for other chronic respiratory diseases.

The study notes some limitations, including that the analysis made use of population, deaths, and data from a number of different sources, all of which are subject to error.

“This analysis expands the amount of information available on chronic respiratory diseases at local levels in several important ways and provides local health authorities and health care professionals with needed information to address the burden of chronic respiratory diseases in their communities,” the authors write.

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

(doi:10.1001/jama.2017.11747)

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 26, 2017

Media Advisory: To contact Phil Veliz, Ph.D., email Jared Wadley at jwadley@umich.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.2017.9087

JAMA

In a survey that included more than 13,000 adolescents, about 20 percent reported at least one diagnosed concussion during their lifetime, and 5.5 percent reported being diagnosed with more than one concussion, according to a study published by JAMA.

Little is known about the prevalence and factors associated with concussions among U.S. adolescents. Providing a national baseline of concussion prevalence and factors is necessary to target and monitor prevention efforts to reduce these types of injuries during this important developmental period. Phil Veliz, Ph.D., of the University of Michigan, Ann Arbor, and colleagues used data from the 2016 Monitoring the Future (MTF) survey, an annual, in-school survey of U.S. students in grades 8, 10, and 12. The survey included the question, “Have you ever had a head injury that was diagnosed as a concussion?” Sociodemographic variables included sex, race/ethnicity, grade level, and participation in competitive sport within the past 12 months.

Among the 13,088 adolescents who participated in the 2016 MTF survey, 50.2 percent were female, 46.8 percent were white, and the most common age was 16 years. In the survey, 19.5 percent reported at least one diagnosed concussion in their lifetime; 14 percent reported one diagnosed concussion; and 5.5 percent reported being diagnosed with more than one concussion. Several factors were associated with higher lifetime prevalence of reporting a diagnosed concussion: being male, white, in a higher grade, and participating in competitive sports. In particular, participation in contact sports was associated with a higher odds of lifetime prevalence of being diagnosed with more than one concussion (11.1 percent).

The study notes some limitations, including the self-report measure of concussion; responses may be biased due to respondents misunderstanding the question or providing inaccurate information.

“These findings are consistent with those from emergency department and regional studies that show that participation in sports is one of the leading causes of concussions among adolescents, and that youth involved in contact sports are at an increased risk for sustaining concussions,” the authors write. “Greater effort to track concussions using large-scale epidemiological data are needed to identify high-risk subpopulations and monitor prevention efforts.”

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

(doi:10.1001/jama.2017.9087)

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

Media Advisory: To contact Sven Sandin, Ph.D., email Rachel Zuckerman at rachel.zuckerman@mountsinai.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.2017.12141

JAMA

Reanalysis of data from a previous study on the familial risk of autism spectrum disorder (ASD) estimates the heritability to be 83 percent, suggesting that genetic factors may explain most of the risk for ASD, according to a study published by JAMA.

Studies have found that autism spectrum disorder (ASD) aggregates in families. In a previous study, ASD heritability was estimated to be 50 percent. To define presence or absence of ASD, the study used a data set created to take into account time-to-event effects in the data, which may have reduced the heritability estimates. Using the same underlying data from this study, Sven Sandin, Ph.D., of the Icahn School of Medicine at Mount Sinai, New York, and colleagues used an alternate method (used by previous studies in the field) to calculate the heritability of ASD.

The study included a group of children born in Sweden 1982 through 2006, with follow-up for ASD through December 2009. The analysis included 37,570 twin pairs, 2,642,064 full sibling pairs, and 432,281 maternal and 445,531 paternal half-sibling pairs. Of these, 14,516 children were diagnosed with ASD. Various models were tested and using the best-fitting model, the ASD heritability was estimated as 83 percent and the nonshared environmental influence was estimated as 17 percent.

“This estimate [83 percent] is slightly lower than the approximately 90 percent estimate reported in earlier twin studies and higher than the 38 percent estimate reported in a California twin study, but was estimated with higher precision. Like earlier twin studies, shared environmental factors contributed minimally to the risk of ASD,” the authors write.

The researchers note that twin and family methods for calculating heritability require several, often untestable assumptions. Because ASD is rare, estimates of heritability rely on few families with more than one affected child, and, coupled with the time trends in ASD prevalence, the heritability estimates are sensitive to the choice of methods.

“The method initially chosen in the previous study led to a lower estimate of heritability of ASD. The current estimate, using traditional methods for defining ASD discordance and concordance, more accurately captures the role of the genetic factors in ASD. However, in both analyses, the heritability of ASD was high and the risk of ASD increased with increasing genetic relatedness,” the researchers write.

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

(doi:10.1001/jama.2017.12141)

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

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

Related material: The editorial, “Improving Blood Pressure Control and Health Systems With Community Health Workers,” by Mark D. Huffman, M.D., M.P.H., of the Northwestern University Feinberg School of Medicine, Chicago, and colleagues 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.2017.11358

JAMA

Low-income patients in Argentina with uncontrolled high blood pressure who participated in a community health worker-led multicomponent intervention experienced a greater decrease in systolic and diastolic blood pressure over 18 months than did patients who received usual care, according to a study published by JAMA.

Despite extensive knowledge of hypertension prevention and treatment, the global prevalence of hypertension is high and increasing, while the proportion of controlled hypertension is low, especially in low- and middle-income countries. Developing and implementing effective, affordable, and sustainable programs for hypertension control is a public health priority in low­ and middle-income countries.

Jiang He, M.D., Ph.D., of the Tulane University School of Public Health and Tropical Medicine, New Orleans, and colleagues randomly assigned to a multicomponent intervention or usual care 18 centers in Argentina providing free health care to uninsured, low-income adult patients with uncontrolled hypertension patients (n = 1,432). The multicomponent intervention included a community health worker-led home intervention (health coaching, home blood pressure [BP] monitoring, and BP audit and feedback), a physician intervention, and a text-messaging intervention.

Over 18 months, patients in the intervention group experienced a greater decrease in systolic and diastolic BP than did patients who received usual care. The proportion of patients with controlled hypertension (BP <140/90 mm Hg) increased from 17 percent at baseline to 73 percent in the intervention group and from 18 percent to 52 percent in the usual care group. The multicomponent intervention significantly increased patients’ adherence to antihypertensive medication and physicians’ adherence to treatment guidelines.

The study notes some limitations, including that selection bias could have occurred. However, patients with hypertension and their family members were systematically recruited to avoid selection bias.

“This study showed that community health workers can play an important role in hypertension control among low-income communities,” the authors write. “Further research is needed to assess generalizability and cost-effectiveness of this intervention and to understand which components may have contributed most to the outcome.”

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

(doi:10.1001/jama.2017.11358)

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

Media Advisory: To contact Deborah Dowell, M.D., M.P.H., email Media@cdc.gov.

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.2017.9308

JAMA

Between 2000 and 2015 in the U.S., life expectancy increased overall but drug-poisoning deaths, mostly related to opioids, contributed to reducing life expectancy, according to a study published by JAMA.

Deaths from drug poisoning more than doubled in the United States from 2000 to 2015; poisoning mortality involving opioids more than tripled. Increases in poisonings have been reported to have reduced life expectancy for non-Hispanic white individuals in the United States from 2000 to 2014. Deborah Dowell, M.D., M.P.H., of the Centers for Disease Control and Prevention, Atlanta, and colleagues estimated the number of deaths and death rates in 2000 and 2015 due to poisoning and the 12 leading causes of death in 2015 using the National Vital Statistics System Mortality file, based on death certificates registered in each state and the District of Columbia.

Life expectancy at birth increased by 2 years overall, rising from 76.8 years in 2000 to 78.8 years in 2015. From 2000 to 2015, death rates related to heart disease, cancer, cerebrovascular diseases, diabetes, influenza and pneumonia, chronic lower respiratory diseases, and kidney disease decreased, together contributing a gain of 2.25 years to the change in life expectancy. Death rates related to unintentional injuries, Alzheimer disease, suicide, chronic liver disease, and septicemia (sepsis) increased, together contributing a loss of 0.33 years to change in life expectancy.

Drug-poisoning deaths increased from 17,415 in 2000 to 52,404 in 2015; the age-adjusted death rate per 100,000 population increased from 6.2 to 16.3, with most of the increase related to opioid deaths. Drug-poisoning deaths contributed a loss of 0.28 years in life expectancy. Most of this loss (96 percent) was unintentional; 0.21 years were lost to opioid-involved poisoning deaths.

The authors note that the contribution of opioid-involved poisoning deaths to the change in life expectancy is likely an underestimate because the accuracy and completeness of information recorded on death certificates affect cause-specific death rates. A specific drug is not recorded in as many as 25 percent of drug-poisoning deaths, although this percentage has modestly declined since 2010.

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

(doi:10.1001/jama.2017.9308)

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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