JAMA

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

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

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

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

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

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

— 400 mg ibuprofen and 1,000 mg acetaminophen

—  5 mg oxycodone and 325 mg acetaminophen

— 5 mg hydrocodone and 300 mg acetaminophen; or

— 30 mg codeine and 300 mg acetaminophen

When: July 2015 to August 2016

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

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

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

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

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

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

Related material:

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

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

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

(doi:10.1001/jama.2017.16190)

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

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, OCTOBER 24, 2017

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

Related material: The editorial, “Robotic-Assisted Surgery,” by Jason D. Wright, M.D., of the Columbia University College of Physicians and Surgeons, New York, also is available at the For The Media website.

To place an electronic embedded link to these studies in your story: These links will be live at the embargo time: first study – https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.14586 2nd study – https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.7219

JAMA

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

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

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

Several limitations of the study are noted in the article.

(doi:10.1001/jama.2017.14825)

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

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

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

Several limitations of the study are noted in the article.

(doi:10.1001/jama.2017.7219)

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, OCTOBER 24, 2017

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

To place an electronic embedded link to this study in your story: This link will be live at the embargo time: https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.11726

JAMA

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.11726)

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EMBARGOED FOR RELEASE: 11 A.M. (ET) TUESDAY, OCTOBER 24, 2017

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

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

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.2017.15097

JAMA

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

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

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

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

“The findings support prehospital transfusion in this setting,” the authors write.

Several limitations of the study are noted in the article.

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

(doi:10.1001/jama.2017.15097)

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

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

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

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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.2017.14825

JAMA

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

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

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

Several limitations of the study are noted in the article.

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

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

(doi:10.1001/jama.2017.14825)

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

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

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.2017.14752

JAMA

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

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

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

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

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

(doi:10.1001/jama.2017.14752)

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

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

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.2017.11483

JAMA

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

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

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

A limitation of the study was its small sample size.

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

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

(doi:10.1001/jama.2017.11483)

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

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

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

JAMA

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

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

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

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

Several limitations of the study are noted in the article.

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

(doi:10.1001/jama.2017.13994)

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

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

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

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

JAMA

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

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

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

Several limitations of the study are noted in the article.

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

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(doi:10.1001/jama.2017.14588)

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

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

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

JAMA

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

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

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

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

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

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

(doi:10.1001/jama.2017.11152)

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

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

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.2017.9984

JAMA

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.9984)

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

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

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.2017.13883

JAMA

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.13883)

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

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

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JAMA

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.13890)

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

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

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

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JAMA

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

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

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

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

Several limitations of the study are noted in the article.

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

(doi:10.1001/jama.2017.14418)

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

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

Related material: The editorial, “Pharmacogenomic Testing and Warfarin,” by Jon D. Emery, M.B.B.Ch., of the University of Melbourne, Australia, also is available at the For The Media website.

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JAMA

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.11463)

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

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

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

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JAMA

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

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.11747)

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

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

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.9087

JAMA

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

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

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

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

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

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

(doi:10.1001/jama.2017.9087)

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

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

To place an electronic embedded link to this study in your story  This link will be live at the embargo time: https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.12141

JAMA

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.12141)

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

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

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

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JAMA

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.11358)

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

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

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JAMA

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

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

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

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

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

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

(doi:10.1001/jama.2017.9308)

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

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

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

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

JAMA

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

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

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

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

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

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

(doi:10.1001/jama.2017.10567)

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

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

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

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

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

JAMA

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

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

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

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

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

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

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(doi:10.1001/jama.2017.11217)

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

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

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

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

JAMA

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

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

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

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

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

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

(doi:10.1001/jama.2017.10981)

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

# # #

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

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

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

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

JAMA

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.13001)

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

# # #

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

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

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

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

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

JAMA

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

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

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.11389)

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

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

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

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

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

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

(doi:10.1001/jama.2017.11387)

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

# # #

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

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

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

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

Note: A list of related embargoed content appears below.

JAMA

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

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

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

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

Detection

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

Benefits of Early Detection and Treatment

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

Harms of Early Detection and Treatment

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

Summary

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

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

(doi:10.1001/jama.2017.11260)

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

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

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

JAMA

Vision Screening in Children Aged 6 Months to 5 Years

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

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

JAMA Ophthalmology

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

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

JAMA Pediatrics

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

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

JAMA Patient Page

Vision Screening in Children

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

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

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

JAMA

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

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.9242)

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

# # #

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

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

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

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

JAMA

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

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

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

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

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

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

(doi:10.1001/jama.2017.7818)

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

# # #

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

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

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

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

JAMA

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

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

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

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

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

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

(doi:10.1001/jama.2017.10572)

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

# # #

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

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

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

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

JAMA

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

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

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

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

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

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

(doi:10.1001/jama.2017.9924)

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

# # #

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

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

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

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

JAMA

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

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.9414)

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

# # #

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

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

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

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

JAMA

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.9415)

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

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

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

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JAMA

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.10169)

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

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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, AUGUST 8, 2017

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

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

JAMA

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

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

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

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

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

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

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

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

(doi:10.1001/jama.2017.7630)

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

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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, AUGUST 8, 2017

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

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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)

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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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