EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 20, 2017

Media Advisory: To contact Suzanne Phelan, Ph.D., email sphelan@calpoly.edu.

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JAMA

An internet-based weight loss program was effective in promoting significant weight loss in low-income postpartum women over 12 months, according to a study published by JAMA.

Approximately 4 million women give birth in the United States each year and, between 2004 and 2008, an estimated 25 percent retained more than 10 pounds of their pregnancy weight and gained additional weight during the postpartum year. Postpartum weight retention increases lifetime risk of obesity and related health issues. Prevalence rates of postpartum weight retention are higher among low-income Hispanic women. Few effective interventions exist for multicultural, low-income women.

Suzanne Phelan, Ph.D., of California Polytechnic State University, San Luis Obispo, and colleagues examined whether an internet-based weight loss program in addition to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC program) for low-income postpartum women could produce greater weight loss than the WIC program alone. Twelve clinics were randomized to the WIC program (standard care group) or the WIC program plus the 12-month primarily internet-based weight loss program (intervention group), including a website with weekly lessons, web diary, instructional videos, computerized feedback, text messages and monthly face-to-face groups at the WIC clinics.

Participants included 371women (82 percent of them Hispanic; their average weight above prepregnancy weight was 17.2 pounds) at clinics randomized to either the intervention group or standard care group. The intervention group had a greater average weight loss over 12 months: 7 pounds compared with 2 pounds in the standard care group. More participants in the intervention group (33 percent) returned to preconception weight by 12 months compared with 19 percent in the standard care group.

Although the greater weight loss of 5 pounds in the intervention group compared with standard care may seem modest, even small postpartum weight retention has been linked to increased risk of later weight gain and development of obesity and diabetes in women, the authors note.

Limitations of the study include that some participants were provided with internet access, which could be cost-prohibitive; however, internet access has increased steadily since 2010 to more than 74 percent of low-income households and 81 percent of the Hispanic population.

“Further research is needed to determine program and cost-effectiveness as part of the WIC program,” the researchers write.

(doi:10.1001/jama.2017.7119)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 20, 2017

Media Advisory: To contact Antonis C. Antoniou, Ph.D., email aca20@medschl.cam.ac.uk.

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JAMA

Researchers conducted an analysis that included nearly 10,000 women with the BRCA1 or BRCA2 genetic mutations to estimate the age-specific risk of breast or ovarian cancer for women with these mutations, according to a study published by JAMA.

The optimal clinical management of women with BRCA1 and BRCA2 mutations depends on accurate age­ specific cancer risk estimates. These can be used to estimate the absolute risk reduction from preventive strategies and to inform decisions about the age at which to begin cancer screening. Antonis C. Antoniou, Ph.D., of the University of Cambridge, England, and colleagues included 6,036 BRCA1 and 3,820 BRCA2 female carriers (5,046 unaffected and 4,810 with breast or ovarian cancer or both at study entry) in the analysis.

During a median follow-up of 5 years, 426 women were diagnosed with breast cancer, 109 with ovarian cancer, and 245 with contralateral breast cancer (cancer in the breast opposite to one previously diagnosed with cancer). Among the findings of the researchers:

• The cumulative breast cancer risk to age 80 years was 72 percent for BRCA1 and 69 percent for BRCA2
• Breast cancer incidences increased rapidly in early adulthood until ages 30 to 40 years for BRCA1 and until ages 40 to 50 years for BRCA2 carriers, then remained at a similar, constant incidence until age 80 years.
• The cumulative ovarian cancer risk to age 80 years was 44 percent for BRCA1 and 17 percent for BRCA2
• For contralateral breast cancer, the cumulative risk 20 years after breast cancer diagnosis was 40 percent for BRCA1 and 26 percent for BRCA2
• Breast cancer risk increased with increasing number of first- and second-degree relatives diagnosed as having breast cancer for both BRCA1 and BRCA2
• Cancer risk varied by mutation location within the BRCAl or BRCA2

Limitations of the study include that although there was variation in the cancer risks for mutation carriers by cancer family history, the study sample was not identified through population screening of unaffected women; therefore, the overall estimates may not be directly applicable to such women.

“The results indicate that family history is a strong risk factor for mutation carriers and that cancer risks vary by mutation location, suggesting that individualized counseling should incorporate both family history profiles and mutation location,” the authors write.

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

(doi:10.1001/jama.2017.7112)

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

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

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JAMA

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians screen for obesity in children and adolescents 6 years and older and offer or refer them to comprehensive, intensive behavioral interventions to promote improvements in weight. The report appears in the June 20 issue of JAMA.

This is a B recommendation, indicating that there is high certainty that the net benefit is moderate, or there is moderate certainty that the net benefit is moderate to substantial.

Approximately 17 percent of children and adolescents ages 2 to19 years in the United States are obese, based on year 2000 Centers for Disease Control and Prevention growth charts, and almost 32 percent are overweight. Obesity in children and adolescents is associated with mental health and psychological issues, asthma, obstructive sleep apnea, orthopedic problems, and adverse cardiovascular and metabolic outcomes such as high blood pressure, abnormal lipid levels, and insulin resistance. Children and adolescents also may experience teasing and bullying based on their weight. Obesity in childhood and adolescence may continue into adulthood and lead to adverse cardiovascular outcomes or other obesity-related issues, such as type 2 diabetes.

To update its 2010 recommendation, the USPSTF reviewed the evidence on screening for obesity in children and adolescents and the benefits and harms of weight management interventions.

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

Detection

In 2005, the USPSTF found that age- and sex-adjusted body mass index (BMI; calculated as weight in kilograms divided by the square of height in meters) percentile is the accepted measure for detecting overweight or obesity in children and adolescents because it is feasible for use in primary care, a reliable measure, and associated with adult obesity.

Benefits of Early Detection and Treatment or Intervention

The USPSTF found adequate evidence that screening and intensive behavioral interventions for obesity in children and adolescents 6 years and older can lead to improvements in weight status. The magnitude of this benefit is moderate. Studies on pharmacotherapy interventions (i.e., metformin and orlistat) showed small amounts of weight loss. The magnitude of this benefit is of uncertain clinical significance, because the evidence regarding the effectiveness of metformin and orlistat is inadequate.

Harms of Early Detection and Treatment or Intervention

The USPSTF found adequate evidence to bound the harms of screening and comprehensive, intensive behavioral interventions for obesity in children and adolescents as small to none, based on the likely minimal harms of using BMI as a screening tool, the absence of reported harms in the evidence on behavioral interventions, and the noninvasive nature of the interventions. Evidence on the harms associated with metformin is inadequate. Adequate evidence shows that orlistat has moderate harms.

Summary

Comprehensive, intensive behavioral interventions (26 or more contact hours) in children and adolescents 6 years and older who have obesity can result in improvements in weight status for up to 12 months; there is inadequate evidence regarding the effectiveness of less intensive interventions. The harms of behavioral interventions can be bounded as small to none, and the harms of screening are minimal. Therefore, the USPSTF concluded with moderate certainty that screening for obesity in children and adolescents 6 years and older is of moderate net benefit.

(doi:10.1001/jama.2017.6803)

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

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 20, 2017

Media Advisory: To contact Pamela L. Lutsey, Ph.D., M.P.H., email Paige Calhoun at pcalhoun@umn.edu.

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JAMA

From 1999 through 2014 the number of U.S. adults taking daily vitamin D supplements above the recommended levels increased, and 3 percent of the population exceeded the daily upper limit considered to possibly pose a risk of adverse effects, according to a study published by JAMA.

A 2011 report concluded that vitamin D was beneficial for bone health but noted possible harm (e.g., abnormally high levels of calcium in the blood, soft tissue or vascular calcification) for intakes above the tolerable upper limit of 4,000 IU daily. The recommended dietary allowance for vitamin D is 600 IU/d for adults 70 years or younger and 800 IU/d for those older than 70 years. Using data from the nationally representative National Health and Nutrition Examination Survey (NHANES), Pamela L. Lutsey, Ph.D., M.P.H., of the University of Minnesota, Minneapolis, and colleagues assessed trends in daily supplemental vitamin D intake of 1,000 IU or more and 4,000 IU or more from 1999 through 2014.

The analysis included 39,243 participants. The researchers found that the prevalence of daily supplemental vitamin D use of 1,000 IU or more in 2013- 2014 was 18.2 percent; in 1999-2000, it was 0.3 percent. In 2013-2014, prevalence of daily supplemental intake of 4,000 IU or more was 3.2 percent; this figure was less than 0.1 percent prior to 2005-2006. Trends of increasing supplemental vitamin D use were found for most age groups, race/ethnicities, and both sexes. In 2013- 2014, intake of 4,000 IU or more daily was highest among women (4.2 percent), non-Hispanic white individuals (3.9 percent), and those 70 years or older (6.6 percent).

A limitation of the study is that data were self-reported; however, participants were asked to bring supplement bottles to aid in reporting.

“Characterizing trends in vitamin D supplementation, particularly at doses above the tolerable upper limit, has important and complex public health and clinical implications,” the authors write.

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

(doi:10.1001/jama.2017.4392)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 13, 2017

Media Advisory: To contact Michael C. Donohue, Ph.D., email Zen Vuong at zvuong@usc.edu or call 213-300-1381.

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JAMA

Among a group of cognitively normal individuals, those who had elevated levels in the brain of the protein amyloid were more likely to experience cognitive decline in the following years, according to a study published by JAMA.

Michael C. Donohue, Ph.D., of the University of Southern California’s Alzheimer’s Therapeutic Research Institute, San Diego, and colleagues conducted a study to characterize and quantify the risk for Alzheimer-related cognitive decline among cognitively normal individuals with elevated brain amyloid, as measured by cerebrospinal fluid or positron emission tomography. Analyses were conducted with cognitive and biomarker (amyloid) data from 445 cognitively normal individuals who were observed for a median of 3.1 years (maximum follow-up, 10.3 years) as part of the Alzheimer’s Disease Neuroimaging Initiative (ADNI).

Among the participants (243 with normal amyloid, 202 with elevated amyloid), the average age was 74 years. The researchers found that compared with the group with normal amyloid, those with elevated amyloid had worse average scores at four years on measures of cognitive function.

“Even though the interpretation was influenced by the small percentage of participants observed for 10 years, this suggests that preclinical Alzheimer disease [AD], defined as clinically normal individuals with elevated brain amyloid, may represent the pre-symptomatic stage of AD. Additional follow-up of the ADNI cohort will be important to confirm these observations. Although this work did not establish a causal role of elevated amyloid in subsequent decline, these results supported other findings (e.g., genetic data) pointing to the critical role of amyloid in the neurobiology of AD,” the authors write.

Limitations of the study include that the use of anti-dementia medications during follow-up was infrequent but greater in the group with elevated amyloid, which may have slowed the progression of cognitive decline in some patients and mildly reduced the between-group difference in rate of decline.

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

(doi:10.1001/jama.2017.6669)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 13, 2017

Media Advisory: To contact Jacquelyn M. Powers, M.D., M.S., email Graciela Gutierrez at ggutierr@bcm.edu.

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JAMA

In a study published by JAMA, Jacquelyn M. Powers, M.D., M.S., of the Baylor College of Medicine, Houston, and colleagues compared two medications, ferrous sulfate and iron polysaccharide complex, for the treatment of nutritional iron-deficiency anemia in infants and children.

Ferrous sulfate is the most commonly prescribed oral iron despite iron polysaccharide complex possibly being better tolerated. Iron-deficiency anemia (IDA) affects millions of persons worldwide, including up to 3 percent of children ages 1 to 2 years in the United States, and is associated with impaired neurodevelopment in infants and children. The most common cause of IDA in this group is inadequate dietary iron intake resulting from excessive cow milk consumption, prolonged breastfeeding without appropriate iron supplementation, or both.

In this study, the researchers randomly assigned 80 infants and children ages 9 months to 4 years with nutritional IDA to three mg/kg of elemental iron once daily as either ferrous sulfate drops or iron polysaccharide complex drops for 12 weeks; 59 completed the trial (28 [70 percent] in the ferrous sulfate group; 31 [78 percent] in the iron polysaccharide complex group). The authors found that ferrous sulfate resulted in a greater increase in hemoglobin concentration at 12 weeks compared with iron polysaccharide complex. The proportion of infants and children with a complete resolution of IDA was higher in the ferrous sulfate group (29 percent vs 6 percent).

“Once daily, low-dose ferrous sulfate should be considered for children with nutritional iron-deficiency anemia,” the authors write.

Limitations of the study include that it was conducted at a single tertiary care children’s hospital.

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

(doi:10.1001/jama.2017.6846)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 13, 2017

Media Advisory: To contact Andreas Claesson, R.N., Ph.D., email andreas.claesson@ki.se.

Related material: Also available below, images of a drone with an AED attached, and embed code of a video of a drone delivering an AED.

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.2017.3957

JAMA

In a study involving simulated out-of-hospital cardiac arrests, drones carrying an automated external defibrillator arrived in less time than emergency medical services, with a reduction in response time of about 16 minutes, according to a study published by JAMA.

Out-of-hospital cardiac arrest (OHCA) in the United States has low survival (8-10 percent), with reducing time to defibrillation as the most important factor for increasing survival. Drones can be activated by a dispatcher and sent to an address provided by a 911 caller and may carry an automated external defibrillator (AED) to the location so that a bystander can use it. Whether drones reduce response times in a real-life situation is unknown. Andreas Claesson, R.N., Ph.D., of the Karolinska Institutet, Stockholm, Sweden, and colleagues compared the time to delivery of an AED using fully autonomous drones for simulated OHCAs vs emergency medical services (EMS).

A drone was developed and certified by the Swedish Transportation Agency and was equipped with an AED (weight, 1.7 lbs.) and placed at a fire station in a municipality north of Stockholm. The drone was equipped with a global positioning system (GPS) and a high-definition camera and integrated with an autopilot software system. It was dispatched for out-of-sight flights in October 2016 to locations where OHCAs within a 6.2 mile radius from the fire station had occurred between 2006 and 2014.

Eighteen remotely operated flights were performed with a median flight distance of about two miles. The median time from call to dispatch of EMS was 3:00 minutes. The median time from dispatch to drone launch was 3 seconds. The median time from dispatch to arrival of the drone was 5:21 minutes vs 22:00 minutes for EMS. The drone arrived more quickly than EMS in all cases with a median reduction in response time of 16:39 minutes.

“Saving 16 minutes is likely to be clinically important. Nonetheless, further test flights, technological development, and evaluation of integration with dispatch centers and aviation administrators are needed,” the authors write. “The outcomes of OHCA using the drone-delivered AED by bystanders vs resuscitation by EMS should be studied.”

Limitations of the study include the small number of flights over short distances in good weather.

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

(doi:10.1001/jama.2017.3957)

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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Images of the drone with the AED

Embed the video: Copy and paste the link below to embed the related video on your website.

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EMBARGOED FOR RELEASE: 7:30 A.M. (ET) SUNDAY, JUNE 4, 2017

Media Advisory: To contact Ethan Basch, M.D., email Bill Schaller at bill_schaller@med.unc.edu or call 617-233-5507.

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JAMA

The integration of electronic patient-reported outcomes into the routine care of patients with metastatic cancer was associated with increased survival compared with usual care, according to a study published by JAMA. The study is being presented at the 2017 ASCO (American Society of Clinical Oncology) annual meeting.

Symptoms are common among patients receiving treatment for advanced cancers, yet are undetected by clinicians up to half the time. There is growing interest in integrating electronic patient-reported outcomes (PROs) into routine oncology practice for symptom monitoring, but evidence demonstrating clinical benefit has been limited. Ethan Basch, M.D., of the Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, and Associate Editor, JAMA, and colleagues assessed overall survival associated with electronic patient-reported symptom monitoring vs usual care based on follow-up from a randomized clinical trial.

Patients initiating routine chemotherapy for metastatic solid tumors at Memorial Sloan Kettering Cancer Center in New York between September 2007 and January 2011 were invited to participate in the trial; participants were randomly assigned either to the usual care group or to the PRO group, in which patients provided self-report of 12 common symptoms at and between visits via a web-based PRO questionnaire platform. When the PRO group participants reported a severe or worsening symptom, an email alert was triggered to a clinical nurse responsible for the care of that patient. A report profiling each participant’s symptom burden history was generated at clinic visits for the treating oncologist.

Overall survival was assessed in June 2016 after 517 of 766 participants (67 percent) had died, at which time the median follow-up was 7 years. Median over-all survival was 31.2 months in the PRO group and 26 months in the usual care group (difference, 5 months).

The authors write that a potential reason for the increased survival is early responsiveness to patient symptoms preventing adverse downstream consequences. Nurses responded to symptom alerts 77 percent of the time with discrete clinical interventions including calls to provide symptom management counseling, supportive medications, chemotherapy dose modifications, and referrals.

Limitations of the study include that is was conducted at a single tertiary care cancer center, although 14 percent of participants were non-white and 22 percent had an educational level of high school or less.

“Electronic patient-reported symptom monitoring may be considered for implementation as a part of high-quality cancer care,” the researchers write.

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

(doi:10.1001/jama.2017.7156)

Editor’s Note: This trial was funded by the Conquer Cancer Foundation of the American Society of Clinical Oncology. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 6, 2017

Media Advisory: To contact Helena J. Teede, M.B.B.S., F.R.A.C.P., Ph.D., email helena.teede@monash.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.2017.3635

JAMA

In an analysis that included more than 1.3 million pregnancies, weight gain during pregnancy that was greater or less than guideline recommendations was associated with a higher risk of adverse outcomes for mothers and infants, compared with weight gain within recommended levels, according to a study published by JAMA.

Body mass index (BMI) and gestational (during pregnancy) weight gain are increasing globally. In 2009, the Institute of Medicine (IOM) provided specific recommendations regarding the ideal gestational weight gain. However, the association between gestational weight gain consistent with the IOM guidelines and pregnancy outcomes is unclear. Rebecca F. Goldstein, M.B.B.S., F.R.A.C.P., Helena J. Teede, M.B.B.S., F.R.A.C.P., Ph.D., of Monash University, Victoria, Australia, and colleagues conducted a systematic review and meta-analysis of 23 studies (n = 1,309,136 women) to evaluate associations between gestational weight gain above or below the IOM guidelines (gain of 27.6 – 39.7 lbs. for underweight women [BMI less than 18.5]; 25.4 – 35.3 lbs. for normal-weight women [BMI 18.5-24.9]; 15.4 – 24.3 lbs., for overweight women [BMI 25-29.9]; and 11 – 19.8 lbs. for obese women [BMI 30 or greater]) and maternal and infant outcomes.

The researchers found that 47 percent of pregnancies had gestational weight gain greater than IOM recommendations and 23 percent had weight gain less than the recommendations. Gestational weight gain below the recommendations was associated with higher risk of small for gestational age (SGA) and preterm birth and lower risk of large for gestational age (LGA) and macrosomia (newborn with an excessive birth weight). Gestational weight gain above the recommendations was associated with lower risk of SGA and preterm birth and higher risk of LGA, macrosomia and cesarean delivery.

Several limitations of the study are noted in the article, including that it lacks studies from developing countries and excluded non-English-language articles.

The World Health Organization has prioritized achievement of ideal BMI prior to conception and prevention of excess gestational weight gain. The authors write that lifestyle interventions in pregnancy can help women attain recommended gestational weight gain.

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

(doi:10.1001/jama.2017.3635)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, JUNE 6, 2017

Media Advisory: To contact Maya Petersen, M.D., Ph.D., email Brett Israel at brett.israel@berkeley.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.2017.5705

JAMA

Among individuals with human immunodeficiency virus (HIV) in rural Kenya and Uganda, implementation of community-based testing and treatment was associated with an increased proportion of HIV-positive adults who achieved viral suppression, along with increased HIV diagnosis and initiation of antiretroviral therapy, according to a study published by JAMA.

Early antiretroviral therapy (ART) improves the health of individuals with HIV and reduces HIV transmission. Models and observational analyses suggest that an intensive global investment to expand ART coverage could alter the epidemic trajectory and improve longevity and health. However, realizing this potential requires diagnosing HIV, initiating ART, and suppressing viral replication in most HIV-positive persons. Maya Petersen, M.D., Ph.D., of the University of California, Berkeley, and colleagues examined changes following implementation of a community-based HIV testing and treatment program in 16 rural Kenyan (n = 6) and Ugandan (n = 10) intervention communities. HIV status and plasma HIV RNA level were measured annually at health campaigns, followed by home-based testing for nonattendees. All HIV-positive individuals were offered ART using a streamlined delivery model designed to reduce structural barriers, improve patient-clinician relationships, and enhance patient knowledge and attitudes about HIV.

Among 77,774 residents (male, 45 percent), HIV prevalence at study entry was 10 percent. The proportion of HIV-positive individuals with HIV viral suppression at study entry was 45 percent and after two years of intervention was 80 percent. Also after two years, 96 percent of HIV-positive individuals had been previously diagnosed (prior to baseline or during the 2-year program); 93 percent of those previously diagnosed had received ART; and 90 percent of those treated had achieved HIV viral suppression.

Several limitations of the study are noted in the article, including that the primary analysis focused on baseline stable community residents due to their full exposure to the intervention; however, these individuals may be easier to test, treat, and suppress than more mobile populations.

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

(doi:10.1001/jama.2017.5705)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, MAY 23, 2017

Media Advisory: To contact Ashish K. Jha, M.D., M.P.H., email Todd Datz at tdatz@hsph.harvard.edu.

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JAMA

In an analysis that included more than 21 million Medicare discharges, admission to a major teaching hospital was associated with a lower overall 30-day risk of death compared with admission to a nonteaching hospital, according to a study published by JAMA.

Academic medical centers (AMCs) are often considered more expensive than community hospitals and some insurers have excluded AMCs from their networks in an attempt to control costs, assuming that quality is comparable. Because evaluating the value of medical care requires consideration of quality as well as cost, understanding whether teaching hospitals provide better care is critical. The seminal studies on this topic are 18 to 25 years old, and it is unclear whether those findings persist in the contemporary health care environment.

Ashish K. Jha, M.D., M.P.H., of the Harvard T.H. Chan School of Public Health, Boston, and colleagues used national Medicare data to compare mortality rates in U.S. teaching and nonteaching hospitals for all hospitalizations and for common medical and surgical conditions among Medicare beneficiaries 65 years and older.

The sample consisted of 21.4 million total hospitalizations at 4,483 hospitals, of which 250 (5.6 percent) were major teaching (members of the Council of Teaching Hospitals), 894 (20 percent) were minor teaching (other hospitals with medical school affiliation), and 3,339 (74 percent) were nonteaching hospitals. After adjusting for patient and hospital characteristics, 30-day mortality was 8.3 percent at major teaching, 9.2 percent at minor teaching, and 9.5 percent at nonteaching hospitals.

After stratifying by hospital size, large (400 beds) and medium-sized (100-399 beds) major teaching hospitals had lower adjusted overall 30-day mortality relative to similarly-sized nonteaching hospitals. Among small (99 beds or less) hospitals, minor teaching hospitals had lower overall 30-day mortality relative to nonteaching hospitals.

“Further study is needed to understand the reasons for these differences,” the authors write.

Several limitations of the study are noted in the article, including that it examined mortality rates for the Medicare fee-for-service population, and thus it was not possible to determine whether these findings are generalizable to nonelderly populations.

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

(doi:10.1001/jama.2017.5702)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, MAY 23, 2017

Media Advisory: To contact Gregory J. Moran, M.D., email Lois Ramirez at loramirez@dhs.lacounty.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.2017.5653

JAMA

Among patients with uncomplicated cellulitis, the use of an antibiotic regimen with activity against MRSA did not result in higher rates of clinical resolution compared to an antibiotic lacking MRSA activity; however, certain findings suggest further research may be needed to confirm these results, according to a study published by JAMA.

Emergency department visits for skin infections in the United States have increased with the emergence of methicillin-resistant Staphylococcus aureus (MRSA). To determine whether addition of a MRSA-active antimicrobial improves outcomes in patients with cellulitis, Gregory J. Moran, M.D., of Olive View–UCLA Medical Center, Los Angeles, and colleagues randomly assigned emergency department patients presenting with cellulitis without a wound or abscess to receive a regimen with activity against MRSA, the antibiotics cephalexin plus trimethoprim-sulfamethoxazole (n = 248), or a regimen lacking MRSA activity, cephalexin plus placebo (n = 248) for 7 days.

Among the participants, 496 were included in the modified intention-to-treat analysis and 411 in the per-protocol analysis. In the per-protocol population, clinical cure occurred in 83.5 percent of participants in the cephalexin plus trimethoprim-sulfamethoxazole group vs 85.5 percent in the cephalexin group. In the modified intention-to-treat population, clinical cure occurred in 76.2 percent of participants in the cephalexin plus trimethoprim-sulfamethoxazole group vs 69 percent in the cephalexin group.

The authors write that because the results from the modified intention-to-treat analysis did not exclude the possibility of clinical superiority of cephalexin plus trimethoprim-sulfamethoxazole, more research may be necessary to more definitively answer this question.

Several limitations of the study are noted in the article, including that even with 500 participants, the power of this trial is limited such that the possibility that regimens with activity against MRSA could improve outcomes in some subgroups cannot be excluded.

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

(doi:10.1001/jama.2017.5653)

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

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EMBARGOED FOR RELEASE: 9:15 A.M. (ET) SUNDAY, MAY 21, 2017

Media Advisory: To contact Nicholas Hart, Ph.D., email Ben Sawtell at Ben.Sawtell@gstt.nhs.uk.

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JAMA

Among patients with an excess of carbon dioxide in their blood (persistent hypercapnia) following a flare-up (acute exacerbation) of chronic obstructive pulmonary disease (COPD), in-home use of a mask and machine to support breathing in addition to home oxygen therapy prolonged the time to hospital readmission or death, according to a study published by JAMA. The study is being released to coincide with its presentation at the 2017 American Thoracic Society International Conference.

Chronic obstructive pulmonary disease is characterized by recurrent flare-ups that can cause intermittent periods of severe clinical deterioration requiring hospitalization and ventilator support. To investigate the effect of home noninvasive ventilation (NIV; use of a mask and machine to support breathing) plus oxygen on time to hospital readmission or death, Nicholas Hart, Ph.D., of Guy’s and St. Thomas’ NHS Foundation Trust, London, and colleagues randomly assigned patients with persistent hypercapnia after a COPD flare-up to home oxygen alone (n = 59) or home oxygen plus home NIV (n = 57).

Sixty-four patients completed the 12-month study, with 28 receiving home oxygen alone and 36 receiving home oxygen plus home NIV. The median time to readmission or death was 4.3 months in the home oxygen plus home NIV group vs 1.4 months in the home oxygen alone group. The 12-month risk of readmission or death was 63 percent in the home oxygen plus home NIV group vs 80 percent in the home oxygen alone group. At 12 months, 16 patients had died in the home oxygen plus home NIV group vs 19 in the home oxygen alone group.

Several limitations of the study are noted in the article, including that the lack of a double-blind design for this trial is a potential criticism. However, the use of a sham device would have the potential to worsen respiratory failure.

“These data support the screening of patients with COPD after receiving acute noninvasive ventilation to identify persistent hypercapnia and introduce home noninvasive ventilation,” the authors write.

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

(doi:10.1001/jama.2017.4451)

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: 2:15 P.M. (ET) SUNDAY, MAY 21, 2017

Media Advisory: To contact Scott D. Halpern, M.D., Ph.D., email Katie Delach at Katie.delach@uphs.upenn.edu.

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JAMA

Physicians were more accurate in predicting the likelihood of death and less accurate in predicting cognitive abilities in six months for critically ill intensive care unit (ICU) patients; nurses’ predictions were similar or less accurate, according to a study published by JAMA. The study is being released to coincide with its presentation at the 2017 American Thoracic Society International Conference.

Predictions of long-term survival and functional outcomes influence decision making for critically ill patients, yet little is known regarding their accuracy. Scott D. Halpern, M.D., Ph.D., of the University of Pennsylvania Pereleman School of Medicine, Philadelphia, and colleagues conducted a study that included five ICUs and patients who spent at least three days in the ICU and required mechanical ventilation, vasopressors, or both. The patients’ attending physicians and bedside nurses were also enrolled.

The study included 303 patients (median age, 62 years); 6-month follow-up was completed for 299 (99 percent), of whom 169 (57 percent) were alive. Predictions were made by 47 physicians and 128 nurses.  Physicians most accurately predicted 6-month mortality and least accurately predicted cognition. Nurses most accurately predicted in-hospital mortality and least accurately predicted cognition. Accuracy was higher when physicians and nurses were confident about their predictions.

Compared with a predictive model including objective clinical variables, a model that also included physician and nurse predictions had significantly higher accuracy for in-hospital mortality, 6-month mortality, and return to original residence.

Several limitations of the study are noted in the article, including that it focused on clinicians’ abilities to discriminate among patients who will or will not experience adverse outcomes but did not assess the calibration of these predictions.

“ICU physicians’ and nurses’ discriminative accuracy in predicting 6-month outcomes of critically ill patients varied depending on the outcome being predicted and confidence of the predictors,” the authors write. “Further research is needed to better understand how clinicians derive prognostic estimates of long-term outcomes.”

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

(doi:10.1001/jama.2017.4078)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, MAY 16, 2017

Media Advisory: To contact Gregory A. Roth, M.D., M.P.H., email Dean Owen at dean1227@uw.edu.

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JAMA

Although the absolute difference in U.S. county-level cardiovascular disease mortality rates have declined substantially over the past 35 years for both ischemic heart disease and cerebrovascular disease, large differences remain, according to a study published by JAMA.

Cardiovascular disease remains the leading cause of death in the United State despite declines in the national cardiovascular disease mortality rate between 1980 and 2015. Mortality rates for smaller regions of the country, such as counties, can differ substantially from the national average; these differences have important implications for local and national health policy. Gregory A. Roth, M.D., M.P.H., of the Division of Cardiology, 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, the National Center for Health Statistics, and the Human Mortality Database from 1980 through 2014 to estimate mortality rates from cardiovascular diseases by U.S. county (n = 3,110).

The researchers found that the mortality rate for cardiovascular diseases in the U.S. declined from 507 deaths per 100,000 persons in 1980 to 253 deaths per 100,000 persons in 2014, a relative decline of 50 percent. In 2014, cardiovascular diseases accounted for more than 846,000 deaths.  There were substantial differences between county ischemic heart disease and stroke mortality rates; smaller differences were found for diseases of the myocardium, atrial fibrillation, aortic and peripheral arterial disease, rheumatic heart disease, and endocarditis.

The largest concentration of counties with high cardiovascular disease mortality extended from southeastern Oklahoma along the Mississippi River Valley to eastern Kentucky. Several cardiovascular disease conditions were clustered substantially outside the South, including atrial fibrillation (Northwest), aortic aneurysm (Midwest), and endocarditis (Mountain West and Alaska). The lowest cardiovascular mortality rates were found in the counties surrounding San Francisco, central Colorado, northern Nebraska, central Minnesota, northeastern Virginia, and southern Florida.

Several limitations of the study are noted in the article, including that vital statistics data and census population data were used to calculate mortality rates and both of these sources are subject to error because deaths and individuals within the population may be missed or allocated to the wrong county.

“These findings suggest major efforts are still needed to reduce geographic variation in risk of death due to ischemic heart disease and cerebrovascular diseases,” the authors write.

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

(doi:10.1001/jama.2017.4150)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, MAY 16, 2017

Media Advisory: To contact Timothy E. McAlindon, D.M., M.P.H., email Jeremy Lechan at jlechan@tuftsmedicalcenter.org.

Video Content: There is a JAMA Report video for this study. It is available under embargo at this link, and includes broadcast-quality downloadable video files, B-roll, scripts and other images.

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JAMA

Among patients with knee osteoarthritis, an injection of a corticosteroid every three months over two years resulted in significantly greater cartilage volume loss and no significant difference in knee pain compared to patients who received a placebo injection, according to a study published by JAMA.

Symptomatic knee osteoarthritis was estimated to affect more than 9 million individuals in the United States in 2005 and is a leading cause of disability and medical costs. Treatments for osteoarthritis are primarily prescribed to reduce symptoms, with no interventions known to influence structural progression. Synovitis (inflammation of a membrane that lines the joints) is common and is associated with progression of structural characteristics of knee osteoarthritis. Intra-articular corticosteroids (an injection in the joint) could reduce cartilage damage associated with synovitis but might have adverse effects on cartilage and bone.

Timothy E. McAlindon, D.M., M.P.H., of Tufts Medical Center, Boston, and colleagues randomly assigned 140 patients with symptomatic knee osteoarthritis with features of synovitis to injections in the joint with the corticosteroid triamcinolone (n = 70) or saline (n = 70) every 12 weeks for two years. The researchers found that injections with triamcinolone resulted in significantly greater cartilage volume loss than did saline (average change in cartilage thickness of -0.21 mm vs -0.10 mm) and no significant difference on measures of pain. The saline group had three treatment-related adverse events compared with five in the triamcinolone group.

Several limitations of the study are noted in the article, including that any transient benefit on pain ending within the 3-month period between each injection could have been missed by methods used in the study.

“These findings do not support this treatment for patients with symptomatic knee osteoarthritis,” the authors write.

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

(doi:10.1001/jama.2017.5283)

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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Embed the JAMA Report video: Copy and paste the link below to embed the related JAMA Report video on your website.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, MAY 16, 2017

Media Advisory: To contact Gregory D. Lewis, M.D., email Julie Cunningham at julie.cunningham@mgh.harvard.edu.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.5427

JAMA

Among patients with a certain type of heart failure and iron deficiency, high-dose iron pills did not improve exercise capacity over 16 weeks, according to a study published by JAMA.

Iron deficiency is present in approximately 50 percent of patients with heart failure with reduced left ventricular ejection fraction (HFrEF; ejection fraction: a measure of how well the left ventricle of the heart pumps with each contraction) and is associated with reduced functional capacity, poorer quality of life, and increased mortality. Although results of intravenous iron repletion trials in iron-deficient heart failure patients have been favorable, regularly treating patients intravenously is expensive and poses logistical challenges. The effectiveness of inexpensive, readily available oral iron supplementation in heart failure is unknown. Gregory D. Lewis, M.D., of Massachusetts General Hospital, Boston, and colleagues randomly assigned 225 patients with HFrEF and iron deficiency to receive oral iron polysaccharide (n = 111) or placebo (n = 114), 150 mg twice daily for 16 weeks.

The researchers found that the primary measured outcome, change in peak oxygen uptake (reflects mechanisms by which iron repletion is expected to improve systemic oxygen delivery and use) from study entry to 16 weeks did not significantly differ between the two groups. There were also no significant differences between treatment groups in changes in 6-minute walk distance.

Several limitations of the study are noted in the article, including that it was not powered to detect differences in clinical events or safety end points.

“These results do not support use of oral iron supplementation in patients with HFrEF,” the authors write.

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

(doi:10.1001/jama.2017.5427)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, MAY 9, 2017

Media Advisory: To contact Joseph S. Ross, M.D., M.H.S., email Ziba Kashef at ziba.kashef@yale.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.2017.5150

JAMA

Among more than 200 new pharmaceuticals and biologics approved by the U.S. Food and Drug Administration from 2001 through 2010, nearly a third were affected by a postmarket safety event such as issuance of a boxed warning or safety communication, according to a study published by JAMA.

The majority of pivotal trials that form the basis for FDA approval for therapeutics (pharmaceuticals and biologics) enroll fewer than 1,000 patients with follow-up of six months or less, which may make it challenging to identify uncommon or long-term serious safety risks. These risks may only become evident when new therapeutics are used in much larger patient populations and for longer durations in the postmarket period. Postmarket safety events can change how these therapeutics are used in clinical practice and inform patient and clinician decision making.

Joseph S. Ross, M.D., M.H.S., of the Yale University School of Medicine, New Haven, Conn., and colleagues examined safety events (a composite of withdrawals due to safety concerns, FDA issuance of incremental boxed warnings added in the postmarket period, and FDA issuance of safety communications) for all novel therapeutics approved by the FDA between January 2001 and December 2010 (followed-up through February 2017).

During this time period, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years, affecting 32 percent of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years, and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 31 percent. Postmarket safety events were significantly more frequent among biologics, therapeutics indicated for the treatment of psychiatric disease, those receiving accelerated approval, and those with near-regulatory deadline approval. Events were significantly less frequent among those with regulatory review times less than 200 days.

The authors write that these findings should be interpreted cautiously but can be used to inform ongoing surveillance efforts.

Limitations of the study are noted in the article.

“The high frequency of postmarket safety events highlights the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle,” the researchers write.

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

(doi:10.1001/jama.2017.5150)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, MAY 9, 2017

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

To place an electronic embedded link to this report in your story  This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.4011

JAMA

The U.S. Preventive Services Task Force (USPSTF) recommends against screening for thyroid cancer in adults without any signs or symptoms. The report appears in the May 9 issue of JAMA.

This is a D recommendation, indicating that there is moderate or high certainty that screening has no net benefit or that the harms outweigh the benefits.

The incidence of thyroid cancer detection has increased by 4.5 percent per year over the last 10 years, faster than for any other cancer; however, the mortality rate from thyroid cancer has not changed substantially, despite the increase in diagnoses. In 2013, the incidence rate of thyroid cancer in the United States was 15.3 cases per 100,000 persons. Most cases of thyroid cancer have a good prognosis; the 5-year survival rate for thyroid cancer overall is 98.1 percent.

To update its 1996 recommendation, the USPSTF reviewed the evidence on the benefits and harms of screening for thyroid cancer in asymptomatic adults, the diagnostic accuracy of screening (including by neck palpation and ultrasound), and the benefits and harms of treatment of screen-detected thyroid cancer.

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

Detection

The USPSTF found inadequate evidence to estimate the accuracy of neck palpation or ultrasound as a screening test for thyroid cancer in asymptomatic persons.

Benefits of Early Detection and Treatment

The USPSTF found inadequate direct evidence to determine whether screening for thyroid cancer in asymptomatic persons using neck palpation or ultrasound improves health outcomes. However, the USPSTF determined that the magnitude of benefit can be bounded as no greater than small, based on the relative rarity of thyroid cancer, the apparent lack of difference in outcomes between patients who are treated vs only monitored (i.e., for the most common tumor types), and the observational evidence demonstrating no change in mortality over time after introduction of a population-based screening program.

Harms of Early Detection and Treatment

The USPSTF found inadequate direct evidence to assess the harms of screening for thyroid cancer in asymptomatic persons. The USPSTF found adequate evidence to bound the magnitude of the overall harms of screening and treatment as at least moderate, based on adequate evidence of serious harms of treatment of thyroid cancer and evidence that overdiagnosis and overtreatment are likely consequences of screening.

Summary

The USPSTF concludes with moderate certainty that screening for thyroid cancer in asymptomatic persons results in harms that outweigh the benefits

(doi:10.1001/jama.2017.4011; the full report is available pre-embargo to the media at the For the Media website)

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

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, MAY 9, 2017

Media Advisory: To contact Pasi A. Jänne, M.D., email Anne Doerr at anne_doerr@dfci.harvard.edu.

Related material: The editorial, “Treatment of KRAS-Mutant Non-Small Cell Lung Cancer,” by Jacob Kaufman, M.D., Ph.D., of Duke University, Durham, N.C., and Thomas E. Stinchcombe, M.D., of the Duke Cancer Institute, 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.2017.3438

JAMA

Among patients previously treated for a type of advanced lung cancer, use of a combination treatment did not improve progression-free or overall survival, according to a study published by JAMA.

Genotype-directed targeted therapy is the standard of care for patients with advanced non-small cell lung cancer (NSCLC). However, there are currently no targeted therapies specifically approved for patients with lung cancers related to a mutation in the KRAS gene, which are detected in approximately 25 percent of lung adenocarcinoma patients. Pasi A. Jänne, M.D., of the Dana-Farber Cancer Institute, Boston, and colleagues randomly assigned 510 patients with previously treated advanced KRAS-mutant non-small cell lung cancer to the drug docetaxel plus selumetinib or docetaxel and placebo. In a phase 2 study (n = 87), selumetinib in combination with docetaxel improved progression-free survival for patients with KRAS-mutant advanced NSCLC. The current study was conducted at 202 sites across 25 countries.

Median duration of randomized treatment, excluding dose interruption time, with selumetinib or placebo was 74 days in the selumetinib + docetaxel group and 85 days in the placebo + docetaxel group. The researchers found that selumetinib + docetaxel did not improve progression-free survival or overall survival compared with placebo + docetaxel. Median progression-free survival was 3.9 months in the selumetinib + docetaxel group and 2.8 months in the placebo + docetaxel group, whereas median overall survival was 8.7 months in the selumetinib + docetaxel group vs 7.9 months in the placebo + docetaxel group. Grade 3 or higher adverse events were more frequent with selumetinib + docetaxel (67 percent) than placebo + docetaxel (45 percent).

Limitations of the study are noted in the article.

“KRAS mutations represent the largest genomically defined subset of lung cancer. There remains a great need to develop effective therapies for this subset of patients and the findings from the present study further highlight this,” the authors write.

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

(doi:10.1001/jama.2017. 3438)

Editor’s Note: This study was funded by AstraZeneca. Roche Molecular Systems provided management in testing the formalin-fixed, paraffin­ embedded tissue samples. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, MAY 9, 2017

Media Advisory: To contact Laurence Fardet, M.D., Ph.D., email laurence.fardet@aphp.fr.

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.2017.2332

JAMA

Long-term off-label use of quinine, still prescribed to individuals with muscle cramps despite Food and Drug Administration warnings of adverse events, is associated with an increased risk of death, according to a study published by JAMA.

Laurence Fardet, M.D., Ph.D., of the Universite Paris Est Creteil, France and colleagues used data from a UK primary care database and included adults who received new quinine salt (sulfate, bisulfate, dihydrochloride) prescriptions for idiopathic (unknown cause) muscular cramps or restless leg syndrome for at least one year from January 1990 to December 2014 at an average dosage of 100 mg/d or more (exposed group).

The study population included 175,195 individuals; median follow-up was 5.7 years. Exposed persons received a median 203 mg/d of quinine. There were 11,598 deaths (4.2 per 100 person-years) among the exposed individuals vs 26,753 (3.2 per 100 person-years) among the unexposed individuals. The increase in the risk of death was more pronounced (approximately three times) in those younger than 50 years. A dose-effect was found for exposure to doses 200 mg/d and higher compared with less than 200 mg/d.

Many drinks such as bitter lemon or tonic waters contain quinine. Individuals in this study received more than 100 mg/d of quinine, equivalent to a daily consumption of more than one liter of bitter lemon or tonic waters.

Limitations of the study are noted in the article.

“The benefits of quinine in reducing cramps should be balanced against the risks,” the authors write.

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

(doi:10.1001/jama.2017.5150)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, MAY 2, 2017

Media Advisory: To contact Ian Larkin, Ph.D., email Elise Anderson at elise.anderson@anderson.ucla.edu.

Related material: The editorial, “Reconsidering Physician-Pharmaceutical Industry Relationships,” by Colette DeJong, B.A., and R. Adams Dudley, M.D., M.B.A., of the University of California, San Francisco, 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.2017.4039

JAMA

Implementation of policies at academic medical centers that restricted pharmaceutical detailing (pharmaceutical representative sales visits to physicians) was associated with modest but significant reductions in prescribing of detailed drugs across six of eight major drug classes; however, changes were not seen in all of the academic medical centers that enacted policies, according to a study published by JAMA in a theme issue on conflict of interest.

In an effort to regulate physician conflicts of interest, a number of academic medical centers (AMCs) enacted policies between 2006 and 2012 restricting sales visits from pharmaceutical representatives to their practicing physicians, by far the most common form of interaction between physicians and the pharmaceutical industry. Little is known about the effect of these policies on physician prescribing. Ian Larkin, Ph.D., of the University of California, Los Angeles, and colleagues compared changes in prescribing by physicians 10 to 36 months before and 12 to 36 months after implementation of detailing policies at AMCs in five states (California, Illinois, Massachusetts, Pennsylvania and New York; intervention group) with changes in prescribing by a matched control group of similar physicians not subject to a detailing policy.

The analysis included 16,121,483 prescriptions written between January 2006 and June 2012 by 2,126 attending physicians at 19 intervention group AMCs and by 24,593 matched control group physicians. The researchers found that enactment of detailing restrictions at AMCs was associated with a decrease in the prescribing of detailed drugs of 1.67 percentage points of market share, and an increase in prescribing of nondetailed drugs of 0.84 percentage points. The average detailed drug had a market share of 19.3 percent and the average nondetailed drug had a market share of 14.2 percent. Associations were statistically significant for six of eight study drug classes for detailed drugs (lipid-lowering drugs, gastroesophageal reflux disease drugs, antihypertensive drugs, sleep aids, attention-deficit/hyperactivity disorder drugs, and antidepressant drugs) and for nine of the 19 AMCs that implemented policies. Across AMCs and drug classes, prescriptions shifted away from detailed drugs and toward generic drugs following the introduction of policies restricting pharmaceutical detailing.

Eleven of the 19 AMCs regulated salesperson gifts to physicians, restricted salesperson access to facilities, and incorporated explicit enforcement mechanisms. For eight of these 11 AMCs, there was a significant change in prescribing. In contrast, there was a significant change at only one of eight AMCs that did not enact policies in all three areas.

The authors note study limitations, including that the observational design precludes proving causal relationships because other changes may have occurred that could have influenced the study results.

The researchers write that the reduction in the prescribing of detailed drugs and the increase in the prescribing of nondetailed drugs potentially represents a large reduction in costs. “In 2010, pharmaceutical companies earned more than $60 billion in revenues for detailed drugs included in the study, and generic drugs are on average 80 percent to 85 percent less expensive than brand-name drugs. A 1-percentage point change in market share could represent approximately a 5 percent relative change in revenue for the average detailed drug, suggesting that the observed changes in prescribing could have important economic implications.”

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

(doi:10.1001/jama.2017.4039)

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, MAY 2, 2017

Media Advisory: To contact Jona A. Hattangadi-Gluth, M.D., email Scott Lafee at slafee@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.2017.3091

JAMA

In 2015, nearly half of physicians were reported to have received a total of $2.4 billion in industry-related payments, primarily involving general payments (including consulting fees and food and beverage), with a higher likelihood and value of payments to physicians in surgical than primary care specialties and to male than female physicians, according to a study published by JAMA in a theme issue on conflict of interest.

Concern for financial conflicts of interest and their effect on patient care, medical research, and education prompted the creation of the Open Payments program, a comprehensive, nationwide public data repository reporting industry payments to physicians and teaching hospitals. Open Payments, implemented under the Affordable Care Act, requires biomedical manufacturers and group purchasing organizations to report all payments and ownership interests made to physicians starting in 2013.

Jona A. Hattangadi-Gluth, M.D., of the University of California, San Diego, La Jolla, and colleagues conducted a study that included 933,295 allopathic and osteopathic U.S. physicians linked to 2015 Open Payments reports of industry payments. Outcomes were compared across specialties (surgery, primary care, specialists, interventionalists) and between male (66 percent) and female (34 percent) physicians.

The researchers found that in 2015, 449,864 of 933,295 physicians (30 percent women), representing approximately 48 percent of all U.S. physicians, were reported to have received $2.4 billion in industry payments, including approximately $1.8 billion for general payments, $544 million for ownership interests (including stock options, partnership shares), and $75 million for research payments. Compared with 48 percent of primary care physicians, 61 percent of surgeons were reported as receiving general payments. Surgeons had an average per-physician reported payment value of $6,879 vs $2,227 among primary care physicians. Men within each specialty had a higher odds of receiving general payments than did women, and reportedly received more royalty or license payments than did women.

The authors note study limitations, including that the Open Payments and National Plan & Provider Enumeration System databases may have inaccuracies and physicians may be unaware of their reported payments.

“Although physicians may consider themselves committed to ethical practice and professionalism, many do not recognize the subconscious bias that industry relationships have on their decision making,” the researchers write. “The Institute of Medicine has highlighted the tension that exists between ‘financial relationships with industry and the primary missions of medical research, education, and practice’. Considerable data have shown that financial conflicts of interest, from small gifts and meals to large sums for consulting, may alter physician decision making. The current population-based analysis of industry-to-physician payments in 2015 shows the far-reaching extent (more than 10 million transactions totaling $2.4 billion) of these reported financial relationships.”

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

(doi:10.1001/jama.2017.3091)

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

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

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

Media Advisory: To contact Douglas A. Corley, M.D., Ph.D., email Janet Byron at Janet.L.Byron@kp.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.2017.3634

JAMA

Among patients with a positive fecal immunochemical test result, compared with follow-up colonoscopy at 8 to 30 days, follow-up after 10 months was associated with a higher risk of colorectal cancer and more advanced-stage disease at the time of diagnosis, according to a study published by JAMA.

Colorectal cancer is the second leading cause of cancer death in the United States. The fecal immunochemical test (FIT) is commonly used for colorectal cancer screening and positive test results need to be followed by a complete colon examination, typically with colonoscopy; however, recommendations for how quickly to complete follow-up differ and lack a strong evidence base. Douglas A. Corley, M.D., Ph.D., of Kaiser Permanente Northern California, Oakland, and colleagues conducted a study that included patients with a positive FIT result who had a follow-up colonoscopy.

Of the 70,124 patients with positive FIT results (median age, 61 years; men, 53 percent), there were 2,191 cases of any colorectal cancer and 601 cases of advanced-stage disease diagnosed. The researchers found that there was no significant increase in risk of overall colorectal cancer or advanced colorectal cancer associated with colonoscopy follow-up within 10 months compared with 8 to 30 days. There was a higher risk of stage II colorectal cancer at 7 to 9 months; of any colorectal cancer, advanced-stage disease, and stage II and IV colorectal cancer at 10 to 12 months; and of advanced adenomas, any colorectal cancer, advanced-stage disease, and stages II-IV colorectal cancer at more than 12 months.

“Further research is needed to assess whether this relationship is causal,” the authors write.

(doi:10.1001/jama.2017.3634)

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, APRIL 25, 2017

Media Advisory: To contact P.J. Devereaux, M.D., Ph.D., email Calyn Pettit at pettitc@hhsc.ca.

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JAMA

Among patients undergoing noncardiac surgery, peak postoperative high-sensitivity troponin T measurements (proteins that are released when the heart muscle has been damaged) during the first three days after surgery were associated with an increased risk of death at 30 days, according to a study published by JAMA.

Large observational studies suggest that among patients 45 years or older undergoing major noncardiac surgery, more than 1 percent die in hospital or within 30 days of surgery. Little is known about the relationship between perioperative high-sensitivity troponin T (hsTnT) measurements and 30-day mortality and myocardial (the muscular tissue of the heart) injury after noncardiac surgery (MINS). P.J. Devereaux, M.D., Ph.D., of McMaster University, Hamilton, Ontario, Canada, and colleagues conducted a study that included patients 45 years or older who underwent inpatient noncardiac surgery and had postoperative hsTnT measurements six to 12 hours after surgery and daily for three days. The patients were recruited at 23 centers in 13 countries.

Among 21,842 participants, the average age was 63 years and 49 percent were female. Death within 30 days after surgery occurred in 266 patients. Analysis indicated that compared with the reference group (peak hsTnT <5 ng/L), peak postoperative hsTnT levels of 20 to less than 65 ng/L had 30-day mortality rates of 3 percent; 65 to less than 1,000 ng/L, a mortality rate of 9.1 percent; and patients with peak postoperative hsTnT levels of 1,000 ng/L or higher had 30-day mortality rates of 29.6 percent.

An absolute hsTnT change of 5 ng/L or higher was associated with an increased risk of 30-day mortality. An elevated postoperative hsTnT without an ischemic feature (e.g., ischemic symptom or electrocardiography finding) was associated with 30-day mortality.

(doi:10.1001/jama.2017.4360)

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, APRIL 25, 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.

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JAMA

The U.S. Preventive Services Task Force (USPSTF) recommends screening for preeclampsia in pregnant women with blood pressure measurements throughout pregnancy. The report appears in the April 25 issue of JAMA.

This is a B recommendation, which in this case indicates that there is moderate certainty that the net benefit is substantial.

Preeclampsia is defined as new-onset hypertension (or, in patients with existing hypertension, worsening hypertension) occurring after 20 weeks of gestation, combined with either new-onset proteinuria (excess protein in the urine) or other signs or symptoms involving multiple organ systems. It is a relatively common hypertensive disorder occurring during pregnancy, affecting approximately four percent of pregnancies in the United States. Preeclampsia can lead to poor health outcomes in both the mother and infant. It is the leading cause of preterm delivery and low birth weight in the United States and may also lead to other serious maternal complications.

To update its 1996 recommendation, the USPSTF reviewed the evidence on the accuracy of screening and diagnostic tests for preeclampsia, the potential benefits and harms of screening for preeclampsia, the effectiveness of risk prediction tools, and the benefits and harms of treatment of screen-detected preeclampsia.

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

Detection

Obtaining blood pressure measurements to screen for preeclampsia could allow for early identification and diagnosis of the condition, resulting in close surveillance and effective treatment to prevent serious complications. The USPSTF has previously established that there is adequate evidence on the accuracy of blood pressure measurements to screen for preeclampsia. The USPSTF found adequate evidence that testing for protein in the urine with a dipstick test has low diagnostic accuracy for detecting proteinuria in pregnancy.

Benefits of Early Detection and Treatment

Preeclampsia is a complex syndrome. It can quickly evolve into a severe disease that can result in serious, even fatal health outcomes for the mother and infant. The ability to screen for preeclampsia using blood pressure measurements is important to identify and effectively treat this potentially unpredictable and fatal condition. The USPSTF found adequate evidence that the well-established treatments of preeclampsia result in a substantial benefit for the mother and infant by reducing maternal and perinatal morbidity and mortality. The USPSTF found inadequate evidence on the effectiveness of risk prediction tools (e.g., clinical indicators, serum markers) that would support different screening strategies for predicting preeclampsia.

Harms of Early Detection and Treatment

The USPSTF found adequate evidence to bound the potential harms of screening for and treatment of preeclampsia as no greater than small. This assessment was based on the known harms of treatment with antihypertension medications, induced labor, and magnesium sulfate; the likely few harms from screening with blood pressure measurements; and the potential poor maternal and perinatal outcomes resulting from severe untreated preeclampsia and eclampsia. The USPSTF found inadequate evidence on the harms of risk prediction.

Summary

The USPSTF concludes with moderate certainty that screening for preeclampsia in pregnant women with blood pressure measurements has a substantial net benefit.

(doi:10.1001/jama.2017.3439; the full report is available pre-embargo to the media at the For the Media website)

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

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

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EMBARGOED FOR RELEASE: 1 P.M. (ET) FRIDAY, APRIL 21, 2017

Media Advisory: To contact Aminu K. Bello, Ph.D., email Tony Kirby at tony@tonykirby.com.

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JAMA

Survey results representing 125 countries indicate there is significant variability in the current capacity for kidney care across the world, including important gaps in services, workforce and available technologies, such as facilities for kidney disease detection and management, according to a study published by JAMA. The study is being released to coincide with its presentation at the International Society of Nephrology Global Kidney Policy Forum.

Kidney disease is a substantial worldwide clinical and public health problem. Acute kidney injury (AKI) and chronic kidney disease (CKD) are linked to high health care costs, poor quality of life, and serious adverse health outcomes (including cardiovascular disease, kidney failure requiring kidney replacement therapy, infection, depression, and death). However, information about available care worldwide is limited.

Aminu K. Bello, Ph.D., of the University of Alberta, Edmonton, Canada, and colleagues analyzed the results of a multinational questionnaire survey conducted from May to September 2016 by the International Society of Nephrology (ISN) in 130 ISN-affiliated countries with sampling of key stakeholders (national nephrology society leadership, policy makers, and patient organization representatives).

Responses were received from 125 of 130 countries (96 percent), representing an estimated 93 percent (6.8 billion) of the world’s population. The researchers found that there was wide variation for kidney care in country readiness, capacity, and response in terms of service delivery, financing, workforce, information systems, and leadership and governance. Overall, 95 percent of countries had facilities for hemodialysis, 76 percent for peritoneal dialysis, and 75 percent for kidney transplantation. In contrast, 94 percent of countries in Africa had facilities for hemodialysis, 45 percent for peritoneal dialysis, and 34 percent for kidney transplantation. For CKD monitoring in primary care, serum creatinine with estimated glomerular filtration rate was reported as always available in 18 percent of countries, and proteinuria measurements in 8 percent of countries.

Hemodialysis was funded publicly and free at the point of care delivery in 42 percent of countries; peritoneal dialysis, in 51 percent of countries, and transplantation services in 49 percent of countries. The number of nephrologists was variable and was low (less than 10 per million population) in Africa, the Middle East, South Asia, and Oceania and South East Asia regions. Health information system (renal registry) availability was limited, particularly for AKI (eight countries [7 percent]) and nondialysis CKD (9 countries [8 percent]). International AKI and CKD guidelines were reportedly accessible in 45 percent and 52 percent of countries, respectively. There was relatively low capacity for clinical studies in developing nations.

“The status of kidney health care as suggested by this study indicates that the health systems of many countries face substantial challenges in closing the large gaps that are reported to currently exist in meeting the health needs of people with AKI and CKD around the world,” the authors write. “Assuming the responses accurately reflect the status of kidney care in the respondent countries, the findings may be useful to inform efforts to improve the quality of kidney care worldwide.”

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

(doi:10.1001/jama.2017.4046)

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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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, APRIL 18, 2017

Media Advisory: To contact Gail Hayward, D.Phil., M.R.C.G.P., email gail.hayward@phc.ox.ac.uk.

Related video: There is a JAMA Report video story on this study available for use in your report. Broadcast-quality downloadable video files, B-roll, scripts and other images are available under embargo at this link. Please contact JAMA Network Media Relations at mediarelations@jamanetwork.org if there are questions.

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JAMA

In patients with a sore throat that didn’t require immediate antibiotics, a single capsule of the corticosteroid dexamethasone didn’t increase the likelihood of complete symptom resolution after 24 hours, and although more patients taking the steroid reported feeling completely better after 48 hours, a role for steroids to treat sore throats in primary care is uncertain, according to a study published by JAMA.

Acute sore throat is one of the most common symptoms among patients presenting to primary care. Adults in the United States made an estimated 92 million visits to doctors for sore throats between 1997 and 2010, an average of 6.6 million visits annually. Antibiotics are prescribed at 60 percent of UK primary care sore throat consultations, despite national guidelines advising against prescriptions. There is a need to find alternative strategies that reduce symptoms and antibiotic consumption.

Gail Hayward, D.Phil., M.R.C.G.P., of the University of Oxford, United Kingdom, and colleagues randomly assigned adults with sore throat not requiring immediate antibiotics to a single oral dose of 10 mg of dexamethasone or placebo. The trial was conducted in 42 family practices in South and West England.

Of 565 eligible randomized participants (median age, 34 years), 288 received dexamethasone and 277 placebo. The researchers found that at 24 hours, participants receiving dexamethasone were not more likely than those receiving placebo to have complete symptom resolution. Results were similar among those who were not offered an antibiotic prescription and those who were offered a delayed antibiotic prescription. At 48 hours, more participants receiving dexamethasone than placebo (35 percent versus 27 percent) had complete symptom resolution, which was also observed in patients not offered delayed antibiotics. There were no significant differences in other outcomes such as days missed from work or school and adverse events.

The authors note that uncertainty remains about the role of oral corticosteroids for patients presenting in primary care with sore throat. “Corticosteroids may have clinical benefit in addition to antibiotics for severe sore throat, for example, to reduce hospital admissions of those patients who are unable to swallow fluids or medications. There have been no trials of corticosteroid use involving these patient groups.”

(doi:10.1001/jama.2017.3417; the study is available pre-embargo at the For the Media website)

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

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

Media Advisory: To contact Simone N. Vigod, M.D., M.Sc., F.R.C.P.C., email Lindsay Jolivet at lindsay.jolivet@wchospital.ca. To contact Brian M. D’Onofrio, Ph.D., email Kevin Fryling at kfryling@iu.edu.

Related material: The editorial, “Disentangling Maternal Depression and Antidepressant Use During Pregnancy as Risks for Autism in Children,” by Tim F. Oberlander, M.D., F.R.C.P.C., University of British Columbia, Vancouver, and Lonnie Zwaigenbaum, M.Sc., M.D., F.R.C.P.C., University of Alberta, Edmonton, also is available at the For The Media website.

To place an electronic embedded link to these studies in your story  These links will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.3415  http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.3413

JAMA

Two studies published by JAMA examine the risk of autism and other adverse birth outcomes among women who use antidepressants during pregnancy.

Previous studies suggesting a higher risk of childhood autism spectrum disorder associated with antidepressant exposure during pregnancy may have been skewed by other factors that can influence the outcomes. Simone N. Vigod, M.D., M.Sc., F.R.C.P.C., of Women’s College Hospital, Toronto, and colleagues evaluated the association between serotonergic antidepressant exposure (a selective serotonin reuptake inhibitor or selective norepinephrine reuptake inhibitor medication) during pregnancy and childhood autism spectrum disorder, using a variety of methods to address those potential confounding factors.

The study included 35,906 births at an average gestational age of 38.7 weeks (average maternal age, 27 years; average duration of follow-up was 5 years). In the 2,837 pregnancies (7.9 percent) exposed to antidepressants, 2 percent of children were diagnosed with autism spectrum disorder. The researchers found that children exposed to serotonergic antidepressants were at higher risk for autism spectrum disorder compared with unexposed children, but after adjusting for confounding, the difference was no longer statistically significant. The association was also not significant when exposed children were compared with unexposed siblings.

“Although a causal relationship cannot be ruled out, the previously observed association may be explained by other factors,” the authors write.

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

(doi:10.1001/jama.2017.3415)

In another study, Brian M. D’Onofrio, Ph.D., of Indiana University, Bloomington, and colleagues evaluated alternative hypotheses for associations between first-trimester antidepressant exposure and birth and neurodevelopmental problems. Previous studies may not have adequately accounted for confounding.

The study included 1,580,629 Swedish offspring (1.4 percent [n = 22,544] with maternal first-trimester self-reported antidepressant use) born between 1996 and 2012 and followed up through 2013.

The researchers found that after accounting for measured pregnancy, maternal and paternal traits, and all (unmeasured) stable familial characteristics shared by siblings, maternal antidepressant use during the first trimester of pregnancy, compared with no exposure, was associated with a small increased risk of preterm birth but no increased risk of small for gestational age, autism spectrum disorder, or attention-deficit/hyperactivity disorder (ADHD).

“These results are consistent with the hypothesis that genetic factors, familial environmental factors, or both account for the population-wide associations between first-trimester antidepressant exposure and these outcomes,” the authors write.

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

(doi:10.1001/jama.2017.3413)

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, APRIL 18, 2017

Media Advisory: To contact Michael J. Pencina, Ph.D., email Amara Omeokwe at amara.omeokwe@duke.edu.

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JAMA

Fewer people could be recommended for primary prevention statin therapy, including many younger adults with high long-term cardiovascular disease risk, if physicians adhere to the 2016 U.S. Preventive Services Task Force (USPSTF) recommendations for statin therapy compared with the 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines, according to a study published by JAMA.

The 2013 ACC/AHA guidelines substantially expanded the population eligible for statin therapy by basing recommendations on an elevated 10-year risk of atherosclerotic cardiovascular disease (ASCVD). The 2016 USPSTF recommendations for primary prevention statin therapy  increased the estimated ASCVD risk threshold for patients (including those with diabetes) and required the presence of at least one cardiovascular risk factor (i.e., hypertension, diabetes, dyslipidemia, or smoking) in addition to elevated risk.

Michael J. Pencina, Ph.D., of Duke University, Durham, N.C., and colleagues used National Health and Nutrition Examination Survey (NHANES) data (2009-2014) to assess statin eligibility under the 2016 USPSTF recommendations vs the 2013 ACC/AHA cholesterol guidelines among a nationally representative sample of 3,416 U.S. adults ages 40 to 75 years with fasting lipid data and triglyceride levels of 400 mg/dl or less, without prior cardiovascular disease (CVD).

The researchers found that if fully implemented, the USPSTF recommendations would be associated with statin initiation in 16 percent of adults without prior CVD, in addition to the 22 percent of adults already taking lipid-lowering therapy; in comparison, the ACC/AHA guidelines would be associated with statin initiation in an additional 24 percent of patients. Among the 8.9 percent of individuals in the primary prevention population who would be recommended for statins by ACC/AHA guidelines but not by USPSTF recommendations, 55 percent would be adults ages 40 to 59 years with an average 30-year cardiovascular risk greater than 30 percent, and 28 percent would have diabetes.

“If these estimates are accurate and assuming these proportions can be projected to the U.S. population, there could be an estimated 17.1 million vs 26.4 million U.S. adults with a new recommendation for statin therapy, based on the USPSTF recommendations vs the ACC/AHA guideline recommendations, respectively—an estimated difference of 9.3 million individuals,” the authors write.

“Alternative approaches to augmenting risk-based cholesterol guidelines, including those that explicitly incorporate potential benefit of therapy, should be considered.”

(doi:10.1001/jama.2017.3416; the study is available pre-embargo at the For the Media website)

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

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

Media Advisory: To contact Rebecca F. Gottesman, M.D., Ph.D., email Vanessa McMains at vmcmain1@jhmi.edu.

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JAMA

Among adults who entered a study more than 25 years ago, an increasing number of midlife vascular risk factors, such as obesity, high blood pressure, diabetes, high cholesterol and smoking, were associated with elevated levels of brain amyloid (protein fragments linked to Alzheimer disease) later in life, according to a study published by JAMA.

Midlife vascular risk factors have been associated with late-life dementia. Whether these risk factors directly contribute to brain amyloid deposition is less well understood. Rebecca F. Gottesman, M.D., Ph.D., of the Johns Hopkins University School of Medicine, Baltimore, and colleagues examined data from 346 participants without dementia at study entry who have been evaluated for vascular risk factors and markers since 1987-1989 and with PET scans in 2011-2013 as part of the Atherosclerosis Risk in Communities (ARIC)-PET Amyloid Imaging Study. Positron emission tomography image analysis was completed in 2015. Vascular risk factors at ARIC study entry (age 45-64 years; risk factors included body mass index 30 or greater, current smoking, hypertension, diabetes, and total cholesterol 200 mg/dL or greater) were evaluated in models that included age, sex, race, APOE genotype, and educational level.

The availability of imaging biomarkers for brain amyloid allows the study of individuals before the development of dementia and thereby allows consideration of the relative contributions of vascular disease and amyloid to cognition, as well as the contribution of vascular disease to amyloid deposition.

The researchers found that a cumulative number of midlife vascular risk factors were associated with elevated brain amyloid. Relationships between vascular risk factors and brain amyloid did not differ by race. The results were not supportive of a significant difference in association among people who were or were not carriers of an APOE ε4 allele (a variant of a gene associated with increased risk for Alzheimer disease). Late-life vascular risk factors were not associated with late-life brain amyloid deposition.

“These data support the concept that midlife, but not late-life, exposure to these vascular risk factors is important for amyloid deposition,” the authors write. “These findings are consistent with a role of vascular disease in the development of AD.”
(doi:10.1001/jama.2017.3090)

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, APRIL 11, 2017

Media Advisory: To contact Paul G. Shekelle, M.D., Ph.D., email Nikki Baker at nikki.baker@va.gov.

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JAMA

Among patients with acute low back pain, spinal manipulation therapy was associated with modest improvements in pain and function at up to 6 weeks, with temporary minor musculoskeletal harms, according to a study published by JAMA.

Back pain is among the most common symptoms prompting patients to seek care. Lifetime prevalence estimates of low back pain exceed 50 percent. Treatments for acute back pain include analgesics, muscle relaxants, exercises, physical therapy, heat, spinal manipulative therapy (SMT) and others, with none established as superior to others. Paul G. Shekelle, M.D., Ph.D., of the West Los Angeles Veterans Affairs Medical Center, Los Angeles, and colleagues conducted a review and meta-analysis of previous studies to assess the effectiveness and harms associated with spinal manipulation compared with other nonmanipulative therapies for adults with acute (six weeks or less) low back pain.

Of 26 eligible randomized clinical trials (RCTs) identified, 15 RCTs (1,711 patients) provided moderate-quality evidence that SMT has a statistically significant association with improvements in pain. Twelve RCTs (1,381 patients) produced moderate-quality evidence that SMT has a statistically significant association with improvements in function. No RCT reported any serious adverse event. Minor transient adverse events such as increased pain, muscle stiffness, and headache were reported 50 percent to 67 percent of the time in large case series of patients treated with SMT. Heterogeneity (differences) in study results was large, and was not explained by type of clinician performing SMT, type of manipulation, study quality, or whether SMT was given alone or as part of a package of therapies.

The authors write that the size of the benefit of SMT for acute low back pain is about the same as the benefit from nonsteroidal anti-inflammatory drugs, according to the Cochrane review on this topic.

(doi:10.1001/jama.2017.3086; the study is available pre-embargo at 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, APRIL 11, 2017

Media Advisory: To contact Jan Bollen, L.L.M., M.D., email jan@janbollen.be.

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JAMA

An estimated 10 percent of all patients undergoing euthanasia in Belgium could potentially donate at least one organ, according to a study published by JAMA.

The practice of organ donation after euthanasia is controversial and currently only allowed in Belgium and the Netherlands. It requires patients to undergo euthanasia in the hospital, and organ donation is performed after circulatory death. Donation after euthanasia could potentially help ease the shortage of organs for transplantation. It is unknown how many of these patients would be medically suitable to donate organs. Jan Bollen, L.L.M., M.D., of Maastricht University Medical Center, Maastricht, the Netherlands, and colleagues calculated the number of potential organ donors among persons undergoing euthanasia by excluding patients because of certain criteria (age, medical condition).

In 2015, 2,023 patients underwent euthanasia in Belgium and 1,288 people were on the Belgian organ transplantation waiting list. The researchers found that an estimated maximum of 10 percent of all patients undergoing euthanasia could potentially donate at least one organ, with 684 organs potentially available for donation. In 2015, 260 deceased donor kidneys were donated; if 400 kidneys were donated by patients undergoing euthanasia, the potential number of kidneys available for donation could more than double.

The authors note that medical suitability only implies that a patient is a possible organ donor. “Whether the patient is also willing to donate, and is willing to die in hospital, must be carefully ascertained.”

“Even if only a small percentage of the patients undergoing euthanasia donated an organ, donation after euthanasia could potentially help reduce the waitlists for organ donation. Nevertheless, it is essential that the primary goal of organ donation after euthanasia remains the same as for any patient donating an organ—to enable patients to carry out their last will of donating organs to help other people, after their own death.”

(doi:10.1001/jama.2017.0729; the study is available pre-embargo at the For the Media website)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, APRIL 4, 2017

Media Advisory: To contact Olivier Baud, M.D., Ph.D., email olivier.baud@rdb.aphp.fr.

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JAMA

The administration of low-dose hydrocortisone to extremely preterm infants was not associated with any adverse effects on neurodevelopmental outcomes at 2 years of age, according to a study published by JAMA.

Early low-dose hydrocortisone treatment in very preterm infants has been reported to improve survival without bronchopulmonary dysplasia (a form of chronic lung disease), but its safety with regard to neurodevelopment remains to be assessed. Olivier Baud, M.D., Ph.D., of Robert Debre Children’s Hospital, Paris, and colleagues analyzed data from the PREMILOC trial, in which infants born between 24 0/7 weeks and 27 6/7 weeks of gestation and before 24 hours of postnatal age were randomly assigned to receive either placebo or low-dose hydrocortisone  injection.

Of neonates screened, 523 were assigned to hydrocortisone (n = 256) or placebo (n = 267) and 406 survived to 2 years of age. A total of 379 patients (93 percent) were evaluated at a median corrected age of 22 months. The researchers found no statistically significant difference in patients without neurodevelopmental impairment (73 percent in the hydrocortisone group vs 70 percent in the placebo group), with mild neurodevelopmental impairment (20 percent in the hydrocortisone group vs 18 percent in the placebo group), or with moderate to severe neurodevelopmental impairment (7 percent in the hydrocortisone group vs 11 percent in the placebo group). The incidence of cerebral palsy or other major neurological impairments was not significantly different between groups.

“Further randomized studies are needed to provide definitive assessment of the neurodevelopmental safety of hydrocortisone in extremely preterm infants,” the authors write.

(doi:10.1001/jama.2017.2692; the study is available pre-embargo at 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, APRIL 4, 2017

Media Advisory: To contact Amanda H. Cook, M.A., email Kristin Samuelson at kristin.samuelson@northwestern.edu.

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JAMA

Cognitively average elderly adults demonstrated greater annual whole-brain cortical volume loss over 18 months compared with SuperAgers, adults 80 years and older with memory ability at least as good as that of average middle-age adults, according to a study published by JAMA.

SuperAgers have a significantly thicker brain cortex than their same-age peers with average-for-age memory, which is unusual as age-related cortical atrophy is considered “normal” and often associated with cognitive decline in nondemented older adults. Amanda H. Cook, M.A., of Northwestern University, Chicago, and colleagues quantitated rates of cortical volume change over 18 months in 24 SuperAgers and 12 cognitively average elderly adults to examine if SuperAgers may resist age-related brain atrophy.

The researchers found that both groups demonstrated statistically significant average annual percent whole-brain cortical volume loss (SuperAgers, 1.06 percent; cognitively average elderly, 2.24 percent). However, the annual percentage change in whole-brain cortical volume loss was significantly greater in cognitively average elderly compared with SuperAgers.

The authors note that the possibility that SuperAgers were endowed with larger brains throughout life cannot be ruled out.

“As SuperAgers represent a rare cognitive phenotype, study findings require validation in larger samples with broader representation of demographic and socioeconomic features. The functional effect of the lesser decline of cortical volume in SuperAgers over 18 months is difficult to surmise. However, the between-group unadjusted difference in annual percentage change of 1.2 percent is similar in magnitude to the difference demonstrated in previous studies between nondemented and demented adults older than 50 years, suggesting that differences of this magnitude may have functional consequences. The factors that underlie the rate of age-related cortical volume loss are unknown; however, research on SuperAgers provides unique opportunities for exploring their biological foundations,” the authors write.

(doi:10.1001/jama.2017.0627; the study is available pre-embargo at 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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