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

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

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

JAMA

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.9478)

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

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

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

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

JAMA

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

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

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

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

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

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

(doi:10.1001/jama.2017.9362)

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

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

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

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

JAMA

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.7464)

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

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

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

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

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

JAMA

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

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.8334)

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

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

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

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

JAMA

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.8982)

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

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

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

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

JAMA

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

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

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

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

Several limitations of the study are noted in the article.

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

(doi:10.1001/jama.2017.8981)

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

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

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

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

JAMA

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.7092)

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

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

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

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

JAMA

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

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

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

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

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

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

(doi:10.1001/jama.2017.7203)

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

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

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

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

JAMA

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

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

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

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

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

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

(doi:10.1001/jama.2017. 8708)

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

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

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

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.8444

JAMA

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

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

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

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

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

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

(doi:10.1001/jama.2017.8444)

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

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

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

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.8036

JAMA

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.8036)

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

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

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

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.8040

JAMA

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

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

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

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

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

(doi:10.1001/jama.2017.8040)

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

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

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

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

JAMA

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

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

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

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

Benefits of Behavioral Counseling Interventions

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

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

Harms of Behavioral Counseling Interventions

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

Summary

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

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

(doi:10.1001/jama.2017.7171)

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

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

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

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

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JAMA

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

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

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

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

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

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

(doi:10.1001/jama.2017.7115)

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

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

Limitations of the study are noted in the article.

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

(doi:10.1001/jama.2017.7117)

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

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

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

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JAMA

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.7918)

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

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

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JAMA

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

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

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

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

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

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

(doi:10.1001/jama.2017.6905)

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

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

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

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

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JAMA

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

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

Among the findings:

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

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

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

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

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

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

(doi:10.1001/jama.2017.7596)

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

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

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

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

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

JAMA

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

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

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

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

Limitations of the study are noted in the article.

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

(doi:10.1001/jama.2017.7220)

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.7217)

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

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

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

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JAMA

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.6204)

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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)

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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)

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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)

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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.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.6846

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: https://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.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.7156

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: https://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: https://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.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.5702

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: https://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.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.4451

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.

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.4078

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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