Jessica Craig

Pre-exposure prophylaxis (PrEP) therapy is safe for HIV-uninfected women breastfeeding their infants, according to a study in PLOS Medicine.

As PrEP becomes more widely used in heterosexual populations, an important consideration is its safety in infants who are breastfed by women taking the drugs, reported Kenneth Mugwanya, MBChB, PhD, of the University of Washington, Seattle, and his associates (PLOS Med. 2016 Sep 27. doi: 10.1371/journal.pmed.1002132).

oksun70/ThinkStock

The purpose of this small, prospective short-term trialwas to quantify drug levels in maternal blood samples, breast milk, and infant blood samples to begin to understand if PrEP is safe for use in pregnant or breastfeeding women at high risk for contracting HIV.

Antiretroviral PrEP with 300 mg tenofovir disoproxil fumarate and 200 mg emtricitabine was administered to 50 HIV-uninfected breastfeeding mothers through daily directly observed therapy for 10 consecutive days and then discontinued thereafter. All mothers were African and resided in Kenya or Uganda. Median maternal age was 25 years; 48% of infants were younger than 12 weeks and 52% were between 13 and 24 weeks of age. Across the study cohort, the median daily frequency of breastfeeding was 15 times.

Maternal blood and breast milk samples were collected and analyzed for drug concentrations at days 7 and 10 of the study. Peak concentration samples, collected 1-2 hours after PrEP administration, and trough concentration levels, collected 23-24 hours after PrEP dose, were collected on day 7 and day 10. Infant blood samples were collected only once, on day 7.

In maternal blood samples, tenofovir was detected at concentrations consistent with steady-state use (median peak concentration, 152.0 ng/mL). In breast milk, tenofovir was present in significantly lower concentrations (3.2 ng/mL). Emtricitabine was also detected at concentrations consistent with steady-state use in maternal blood samples (median peak concentration, 267.5 ng/mL); however, unlike tenofovir, emtricitabine concentration in breast milk was similar to peak plasma concentrations (212.5 ng/mL). Tenofovir was undetectable in 46 of 49 (94%) infant plasma samples. For the three infants with detectable tenofovir, the plasma concentrations were 0.9, 0.9, and 17.4 ng/mL, corresponding body weights were 6.4, 5.8, and 6.2 kg, and their maternal milk tenofovir concentrations were “modestly greater” than the median at 6.57, 3.64, and 4.05 ng/mL, respectively.

Emtricitabine, on the other hand, was detectable in 47 of 49 (96%) infant plasma samples with a median concentration of 13.2 ng/mL.

“The estimated daily tenofovir and emtricitabine doses ingested by the infant through breastfeeding were 12,500-fold and 200-fold, respectively, lower than the proposed daily pediatric dose for prophylaxis against vertical HIV acquisition. Thus, infants had low exposures to tenofovir and emtricitabine, which would not be expected to pose substantial safety risk to infants of mothers who use PrEP during breastfeeding,” Dr. Mugwanya and his associates wrote.

“These data provide evidence suggesting that this PrEP regimen can be safely used during breastfeeding, which is informative for clinical guidelines for women who are at substantial risk of HIV during pregnancy and the postpartum period,” the researchers concluded.

This study was funded by the Bill and Melinda Gates Foundation and the National Institutes of Health. The authors did not report disclosures.

[email protected]

On Twitter @jessnicolecraig

Pre-exposure prophylaxis (PrEP) therapy is safe for HIV-uninfected women breastfeeding their infants, according to a study in PLOS Medicine.

As PrEP becomes more widely used in heterosexual populations, an important consideration is its safety in infants who are breastfed by women taking the drugs, reported Kenneth Mugwanya, MBChB, PhD, of the University of Washington, Seattle, and his associates (PLOS Med. 2016 Sep 27. doi: 10.1371/journal.pmed.1002132).

oksun70/ThinkStock

The purpose of this small, prospective short-term trialwas to quantify drug levels in maternal blood samples, breast milk, and infant blood samples to begin to understand if PrEP is safe for use in pregnant or breastfeeding women at high risk for contracting HIV.

Antiretroviral PrEP with 300 mg tenofovir disoproxil fumarate and 200 mg emtricitabine was administered to 50 HIV-uninfected breastfeeding mothers through daily directly observed therapy for 10 consecutive days and then discontinued thereafter. All mothers were African and resided in Kenya or Uganda. Median maternal age was 25 years; 48% of infants were younger than 12 weeks and 52% were between 13 and 24 weeks of age. Across the study cohort, the median daily frequency of breastfeeding was 15 times.

Maternal blood and breast milk samples were collected and analyzed for drug concentrations at days 7 and 10 of the study. Peak concentration samples, collected 1-2 hours after PrEP administration, and trough concentration levels, collected 23-24 hours after PrEP dose, were collected on day 7 and day 10. Infant blood samples were collected only once, on day 7.

In maternal blood samples, tenofovir was detected at concentrations consistent with steady-state use (median peak concentration, 152.0 ng/mL). In breast milk, tenofovir was present in significantly lower concentrations (3.2 ng/mL). Emtricitabine was also detected at concentrations consistent with steady-state use in maternal blood samples (median peak concentration, 267.5 ng/mL); however, unlike tenofovir, emtricitabine concentration in breast milk was similar to peak plasma concentrations (212.5 ng/mL). Tenofovir was undetectable in 46 of 49 (94%) infant plasma samples. For the three infants with detectable tenofovir, the plasma concentrations were 0.9, 0.9, and 17.4 ng/mL, corresponding body weights were 6.4, 5.8, and 6.2 kg, and their maternal milk tenofovir concentrations were “modestly greater” than the median at 6.57, 3.64, and 4.05 ng/mL, respectively.

Emtricitabine, on the other hand, was detectable in 47 of 49 (96%) infant plasma samples with a median concentration of 13.2 ng/mL.

“The estimated daily tenofovir and emtricitabine doses ingested by the infant through breastfeeding were 12,500-fold and 200-fold, respectively, lower than the proposed daily pediatric dose for prophylaxis against vertical HIV acquisition. Thus, infants had low exposures to tenofovir and emtricitabine, which would not be expected to pose substantial safety risk to infants of mothers who use PrEP during breastfeeding,” Dr. Mugwanya and his associates wrote.

“These data provide evidence suggesting that this PrEP regimen can be safely used during breastfeeding, which is informative for clinical guidelines for women who are at substantial risk of HIV during pregnancy and the postpartum period,” the researchers concluded.

This study was funded by the Bill and Melinda Gates Foundation and the National Institutes of Health. The authors did not report disclosures.

[email protected]

On Twitter @jessnicolecraig

Pre-exposure prophylaxis (PrEP) therapy is safe for HIV-uninfected women breastfeeding their infants, according to a study in PLOS Medicine.

As PrEP becomes more widely used in heterosexual populations, an important consideration is its safety in infants who are breastfed by women taking the drugs, reported Kenneth Mugwanya, MBChB, PhD, of the University of Washington, Seattle, and his associates (PLOS Med. 2016 Sep 27. doi: 10.1371/journal.pmed.1002132).

oksun70/ThinkStock

The purpose of this small, prospective short-term trialwas to quantify drug levels in maternal blood samples, breast milk, and infant blood samples to begin to understand if PrEP is safe for use in pregnant or breastfeeding women at high risk for contracting HIV.

Antiretroviral PrEP with 300 mg tenofovir disoproxil fumarate and 200 mg emtricitabine was administered to 50 HIV-uninfected breastfeeding mothers through daily directly observed therapy for 10 consecutive days and then discontinued thereafter. All mothers were African and resided in Kenya or Uganda. Median maternal age was 25 years; 48% of infants were younger than 12 weeks and 52% were between 13 and 24 weeks of age. Across the study cohort, the median daily frequency of breastfeeding was 15 times.

Maternal blood and breast milk samples were collected and analyzed for drug concentrations at days 7 and 10 of the study. Peak concentration samples, collected 1-2 hours after PrEP administration, and trough concentration levels, collected 23-24 hours after PrEP dose, were collected on day 7 and day 10. Infant blood samples were collected only once, on day 7.

In maternal blood samples, tenofovir was detected at concentrations consistent with steady-state use (median peak concentration, 152.0 ng/mL). In breast milk, tenofovir was present in significantly lower concentrations (3.2 ng/mL). Emtricitabine was also detected at concentrations consistent with steady-state use in maternal blood samples (median peak concentration, 267.5 ng/mL); however, unlike tenofovir, emtricitabine concentration in breast milk was similar to peak plasma concentrations (212.5 ng/mL). Tenofovir was undetectable in 46 of 49 (94%) infant plasma samples. For the three infants with detectable tenofovir, the plasma concentrations were 0.9, 0.9, and 17.4 ng/mL, corresponding body weights were 6.4, 5.8, and 6.2 kg, and their maternal milk tenofovir concentrations were “modestly greater” than the median at 6.57, 3.64, and 4.05 ng/mL, respectively.

Emtricitabine, on the other hand, was detectable in 47 of 49 (96%) infant plasma samples with a median concentration of 13.2 ng/mL.

“The estimated daily tenofovir and emtricitabine doses ingested by the infant through breastfeeding were 12,500-fold and 200-fold, respectively, lower than the proposed daily pediatric dose for prophylaxis against vertical HIV acquisition. Thus, infants had low exposures to tenofovir and emtricitabine, which would not be expected to pose substantial safety risk to infants of mothers who use PrEP during breastfeeding,” Dr. Mugwanya and his associates wrote.

“These data provide evidence suggesting that this PrEP regimen can be safely used during breastfeeding, which is informative for clinical guidelines for women who are at substantial risk of HIV during pregnancy and the postpartum period,” the researchers concluded.

This study was funded by the Bill and Melinda Gates Foundation and the National Institutes of Health. The authors did not report disclosures.

[email protected]

On Twitter @jessnicolecraig

Prenatal Tdap vaccination prevents the occurrence of and reduces the severity of pertussis in infants, two retrospective cohort studies showed.

In 2012, the Advisory Committee on Immunization Practices recommended that pregnant women receive a Tdap vaccination during their third trimester of pregnancy to optimize the transfer of pertussis antibodies to the fetus. Since the committee’s recommendation, no studies to evaluate the effectiveness of this strategy have been conducted in the United States, Kathleen Winter of the California Department of Public Health and her associates reported (Clin. Infect. Dis. 2016. doi: 10.1093/cid/ciw634) .

Therefore, Ms. Winter and her associates conducted two separate retrospective cohort studies: one to compare the effectiveness of prenatal versus postpartum Tdap vaccination in preventing pertussis and the second to investigate the effectiveness of prenatal Tdap vaccination on pertussis severity in infants.

For the comparison study, researchers identified 42,941 mothers who were vaccinated during pregnancy and 31,563 mothers who were vaccinated following delivery. The stage of pregnancy at the time of vaccination was documented for 42,218 of the mothers vaccinated prenatally, and 77% were vaccinated during the recommended window of 27-36 weeks’ gestation. For the remaining mothers, 14% received vaccinations before 27 weeks’ gestation, and 9% were vaccinated after 36 weeks’ gestation. Infants whose mothers received the Tdap vaccine at any point during pregnancy were less likely to develop pertussis before 8 weeks of age (odds ratio, 0.36; 95% confidence interval, 0.15-0.89) or 12 weeks of age (OR, 0.47; 95% CI, 0.24-0.92).

Moreover, infants whose mothers received the vaccine during 27-36 weeks’ gestation were less likely to develop pertussis than were infants whose mothers were vaccinated during pregnancy but outside the 27- to 36-week time frame (OR, 0.22; 95% CI, 0.08-0.63).

Overall, Tdap vaccination during 27-36 weeks’ gestation was 85% more effective in reducing pertussis in infants younger than 8 weeks old and 72% more effective in preventing pertussis in infants younger than 12 weeks old, compared with postpartum vaccination.

In a companion paper, researchers described the results of a separate retrospective cohort study, the “first known study demonstrating that prenatal Tdap vaccination reduces severity of disease in infants who are infected with pertussis,” according to Ms. Winter and her associates (Clin. Infect. Dis. 2016. doi: 10.1093/cid/ciw633).

For this study, the researchers identified 420 infants born between January 2011 and December 2015 who reported with pertussis at less than 63 days of age and had known maternal vaccination status. Of those 420 infants, only 49 mothers (12%) received Tdap vaccination during pregnancy, and only 14 received Tdap during the recommended window of 27-36 weeks’ gestation.

Infants born to mothers who received the Tdap vaccine during pregnancy were significantly less likely to be hospitalized when they developed pertussis (OR, 0.4; 95% CI, 0.2-0.9), were less likely to be admitted to the intensive care unit (OR, 0.5; 95% CI, 0.2-1.2), and had shorter hospital stays (median, 3 days vs. 6 days; P = .019). Infants born to vaccinated mothers also were older when they developed pertussis and were less likely to display common pertussis symptoms: paroxysmal cough, apnea, cyanosis, and whoop.

“Prenatal Tdap vaccination was 58% effective in preventing hospitalizations in infants infected with pertussis,” the researchers wrote, adding that “prenatal Tdap vaccination of mothers is a critical strategy for reducing the morbidity and mortality from pertussis.”

[email protected]

On Twitter @jessnicolecraig

Prenatal Tdap vaccination prevents the occurrence of and reduces the severity of pertussis in infants, two retrospective cohort studies showed.

In 2012, the Advisory Committee on Immunization Practices recommended that pregnant women receive a Tdap vaccination during their third trimester of pregnancy to optimize the transfer of pertussis antibodies to the fetus. Since the committee’s recommendation, no studies to evaluate the effectiveness of this strategy have been conducted in the United States, Kathleen Winter of the California Department of Public Health and her associates reported (Clin. Infect. Dis. 2016. doi: 10.1093/cid/ciw634) .

Therefore, Ms. Winter and her associates conducted two separate retrospective cohort studies: one to compare the effectiveness of prenatal versus postpartum Tdap vaccination in preventing pertussis and the second to investigate the effectiveness of prenatal Tdap vaccination on pertussis severity in infants.

For the comparison study, researchers identified 42,941 mothers who were vaccinated during pregnancy and 31,563 mothers who were vaccinated following delivery. The stage of pregnancy at the time of vaccination was documented for 42,218 of the mothers vaccinated prenatally, and 77% were vaccinated during the recommended window of 27-36 weeks’ gestation. For the remaining mothers, 14% received vaccinations before 27 weeks’ gestation, and 9% were vaccinated after 36 weeks’ gestation. Infants whose mothers received the Tdap vaccine at any point during pregnancy were less likely to develop pertussis before 8 weeks of age (odds ratio, 0.36; 95% confidence interval, 0.15-0.89) or 12 weeks of age (OR, 0.47; 95% CI, 0.24-0.92).

Moreover, infants whose mothers received the vaccine during 27-36 weeks’ gestation were less likely to develop pertussis than were infants whose mothers were vaccinated during pregnancy but outside the 27- to 36-week time frame (OR, 0.22; 95% CI, 0.08-0.63).

Overall, Tdap vaccination during 27-36 weeks’ gestation was 85% more effective in reducing pertussis in infants younger than 8 weeks old and 72% more effective in preventing pertussis in infants younger than 12 weeks old, compared with postpartum vaccination.

In a companion paper, researchers described the results of a separate retrospective cohort study, the “first known study demonstrating that prenatal Tdap vaccination reduces severity of disease in infants who are infected with pertussis,” according to Ms. Winter and her associates (Clin. Infect. Dis. 2016. doi: 10.1093/cid/ciw633).

For this study, the researchers identified 420 infants born between January 2011 and December 2015 who reported with pertussis at less than 63 days of age and had known maternal vaccination status. Of those 420 infants, only 49 mothers (12%) received Tdap vaccination during pregnancy, and only 14 received Tdap during the recommended window of 27-36 weeks’ gestation.

Infants born to mothers who received the Tdap vaccine during pregnancy were significantly less likely to be hospitalized when they developed pertussis (OR, 0.4; 95% CI, 0.2-0.9), were less likely to be admitted to the intensive care unit (OR, 0.5; 95% CI, 0.2-1.2), and had shorter hospital stays (median, 3 days vs. 6 days; P = .019). Infants born to vaccinated mothers also were older when they developed pertussis and were less likely to display common pertussis symptoms: paroxysmal cough, apnea, cyanosis, and whoop.

“Prenatal Tdap vaccination was 58% effective in preventing hospitalizations in infants infected with pertussis,” the researchers wrote, adding that “prenatal Tdap vaccination of mothers is a critical strategy for reducing the morbidity and mortality from pertussis.”

[email protected]

On Twitter @jessnicolecraig

Prenatal Tdap vaccination prevents the occurrence of and reduces the severity of pertussis in infants, two retrospective cohort studies showed.

In 2012, the Advisory Committee on Immunization Practices recommended that pregnant women receive a Tdap vaccination during their third trimester of pregnancy to optimize the transfer of pertussis antibodies to the fetus. Since the committee’s recommendation, no studies to evaluate the effectiveness of this strategy have been conducted in the United States, Kathleen Winter of the California Department of Public Health and her associates reported (Clin. Infect. Dis. 2016. doi: 10.1093/cid/ciw634) .

Therefore, Ms. Winter and her associates conducted two separate retrospective cohort studies: one to compare the effectiveness of prenatal versus postpartum Tdap vaccination in preventing pertussis and the second to investigate the effectiveness of prenatal Tdap vaccination on pertussis severity in infants.

For the comparison study, researchers identified 42,941 mothers who were vaccinated during pregnancy and 31,563 mothers who were vaccinated following delivery. The stage of pregnancy at the time of vaccination was documented for 42,218 of the mothers vaccinated prenatally, and 77% were vaccinated during the recommended window of 27-36 weeks’ gestation. For the remaining mothers, 14% received vaccinations before 27 weeks’ gestation, and 9% were vaccinated after 36 weeks’ gestation. Infants whose mothers received the Tdap vaccine at any point during pregnancy were less likely to develop pertussis before 8 weeks of age (odds ratio, 0.36; 95% confidence interval, 0.15-0.89) or 12 weeks of age (OR, 0.47; 95% CI, 0.24-0.92).

Moreover, infants whose mothers received the vaccine during 27-36 weeks’ gestation were less likely to develop pertussis than were infants whose mothers were vaccinated during pregnancy but outside the 27- to 36-week time frame (OR, 0.22; 95% CI, 0.08-0.63).

Overall, Tdap vaccination during 27-36 weeks’ gestation was 85% more effective in reducing pertussis in infants younger than 8 weeks old and 72% more effective in preventing pertussis in infants younger than 12 weeks old, compared with postpartum vaccination.

In a companion paper, researchers described the results of a separate retrospective cohort study, the “first known study demonstrating that prenatal Tdap vaccination reduces severity of disease in infants who are infected with pertussis,” according to Ms. Winter and her associates (Clin. Infect. Dis. 2016. doi: 10.1093/cid/ciw633).

For this study, the researchers identified 420 infants born between January 2011 and December 2015 who reported with pertussis at less than 63 days of age and had known maternal vaccination status. Of those 420 infants, only 49 mothers (12%) received Tdap vaccination during pregnancy, and only 14 received Tdap during the recommended window of 27-36 weeks’ gestation.

Infants born to mothers who received the Tdap vaccine during pregnancy were significantly less likely to be hospitalized when they developed pertussis (OR, 0.4; 95% CI, 0.2-0.9), were less likely to be admitted to the intensive care unit (OR, 0.5; 95% CI, 0.2-1.2), and had shorter hospital stays (median, 3 days vs. 6 days; P = .019). Infants born to vaccinated mothers also were older when they developed pertussis and were less likely to display common pertussis symptoms: paroxysmal cough, apnea, cyanosis, and whoop.

“Prenatal Tdap vaccination was 58% effective in preventing hospitalizations in infants infected with pertussis,” the researchers wrote, adding that “prenatal Tdap vaccination of mothers is a critical strategy for reducing the morbidity and mortality from pertussis.”

[email protected]

On Twitter @jessnicolecraig

Clinical outcomes of surgery and patient-reported outcomes of function, disability, and health status are two different measures of surgical success.

A large study of patients who had bariatric surgery showed that patient-reported outcomes were correlated with long-term weight loss but not with short-term complication rates. In addition, obesity-specific patient-reported quality of life scores were associated with a reduction in medications required for the treatment of obesity-related conditions.

“Clinical outcomes, such as perioperative morbidity and mortality, are commonly used to benchmark hospital performance,” reported Jennifer F. Waljee, MD, and her associates at the University of Michigan, Ann Arbor (Ann Surg. 2016. doi: 10.1097/SLA.0000000000001852).

“However, for many surgical procedures, such as bariatric surgery ... complications may be rare, and may not entirely reflect treatment effectiveness. Alternatively, patient-reported measures of function, disability, and health status may offer a unique and more reliable assessment of provider quality and performance,” she explained. Yet despite growing interest in using patient-reported measures, many important questions regarding their accuracy, applicability, and clinical utility remain. The purpose of this study was, therefore, to evaluate how patient-reported quality of life measures compared to short-term and long-term clinical outcomes in patients who underwent bariatric surgery.

©Vasilis Varsakelis/fotolia.com

The majority of the study’s 11,420 participants were female (79.8%), were white (84.1%), and underwent Roux-en-Y laparoscopic gastric bypass (56.8%). For each study participant, both short-term and long-term clinical outcome measures were obtained from medical board review. Short-term clinical outcomes were defined as the rate of perioperative complications within 30 days of bariatric surgery. Percent excess weight loss at 1 year post surgery was used as a long-term clinical outcome.

In addition, two patient-reported outcomes were collected: an overall health-related quality of life score called the Health and Activities Limitations Index (HALex) and an obesity-specific quality of life score, the Bariatric Quality of Life (BQL) index, which measures well-being, social and physical functioning, and obesity-related symptoms.

Multivariate and linear regression models demonstrated that short-term complication rates were not correlated to the overall patient-reported quality of life score (P = .32) or to the obesity-specific BQL score (P = .74).

However, the long-term measure of excess weight loss at 1 year post surgery was significantly associated with both overall and obesity-specific patient-reported measures of health-related quality of life (P less than .002 and P less than .001 respectively).

Moreover, scores indicating improved quality of life were associated with greater weight loss.

Finally, comorbidity resolution, estimated by the reduction in the use of medications taken to treat conditions related to obesity, was significantly associated with the obesity-specific measure, BQL, but not the overall quality of life measure, HALex.

“In conclusion, [patient-reported outcomes] are distinct from clinical outcomes,” investigators wrote. Patient-reported outcomes “provide an opportunity for improved population-based cost-effectiveness analyses using outcomes germane to procedures performed for symptomatology and improving QOL,” they added.

The Agency for Healthcare Research and Quality supported the research. The investigators reported having no disclosures.

[email protected]

On Twitter @jessnicolecraig

Clinical outcomes of surgery and patient-reported outcomes of function, disability, and health status are two different measures of surgical success.

A large study of patients who had bariatric surgery showed that patient-reported outcomes were correlated with long-term weight loss but not with short-term complication rates. In addition, obesity-specific patient-reported quality of life scores were associated with a reduction in medications required for the treatment of obesity-related conditions.

“Clinical outcomes, such as perioperative morbidity and mortality, are commonly used to benchmark hospital performance,” reported Jennifer F. Waljee, MD, and her associates at the University of Michigan, Ann Arbor (Ann Surg. 2016. doi: 10.1097/SLA.0000000000001852).

“However, for many surgical procedures, such as bariatric surgery ... complications may be rare, and may not entirely reflect treatment effectiveness. Alternatively, patient-reported measures of function, disability, and health status may offer a unique and more reliable assessment of provider quality and performance,” she explained. Yet despite growing interest in using patient-reported measures, many important questions regarding their accuracy, applicability, and clinical utility remain. The purpose of this study was, therefore, to evaluate how patient-reported quality of life measures compared to short-term and long-term clinical outcomes in patients who underwent bariatric surgery.

©Vasilis Varsakelis/fotolia.com

The majority of the study’s 11,420 participants were female (79.8%), were white (84.1%), and underwent Roux-en-Y laparoscopic gastric bypass (56.8%). For each study participant, both short-term and long-term clinical outcome measures were obtained from medical board review. Short-term clinical outcomes were defined as the rate of perioperative complications within 30 days of bariatric surgery. Percent excess weight loss at 1 year post surgery was used as a long-term clinical outcome.

In addition, two patient-reported outcomes were collected: an overall health-related quality of life score called the Health and Activities Limitations Index (HALex) and an obesity-specific quality of life score, the Bariatric Quality of Life (BQL) index, which measures well-being, social and physical functioning, and obesity-related symptoms.

Multivariate and linear regression models demonstrated that short-term complication rates were not correlated to the overall patient-reported quality of life score (P = .32) or to the obesity-specific BQL score (P = .74).

However, the long-term measure of excess weight loss at 1 year post surgery was significantly associated with both overall and obesity-specific patient-reported measures of health-related quality of life (P less than .002 and P less than .001 respectively).

Moreover, scores indicating improved quality of life were associated with greater weight loss.

Finally, comorbidity resolution, estimated by the reduction in the use of medications taken to treat conditions related to obesity, was significantly associated with the obesity-specific measure, BQL, but not the overall quality of life measure, HALex.

“In conclusion, [patient-reported outcomes] are distinct from clinical outcomes,” investigators wrote. Patient-reported outcomes “provide an opportunity for improved population-based cost-effectiveness analyses using outcomes germane to procedures performed for symptomatology and improving QOL,” they added.

The Agency for Healthcare Research and Quality supported the research. The investigators reported having no disclosures.

[email protected]

On Twitter @jessnicolecraig

Clinical outcomes of surgery and patient-reported outcomes of function, disability, and health status are two different measures of surgical success.

A large study of patients who had bariatric surgery showed that patient-reported outcomes were correlated with long-term weight loss but not with short-term complication rates. In addition, obesity-specific patient-reported quality of life scores were associated with a reduction in medications required for the treatment of obesity-related conditions.

“Clinical outcomes, such as perioperative morbidity and mortality, are commonly used to benchmark hospital performance,” reported Jennifer F. Waljee, MD, and her associates at the University of Michigan, Ann Arbor (Ann Surg. 2016. doi: 10.1097/SLA.0000000000001852).

“However, for many surgical procedures, such as bariatric surgery ... complications may be rare, and may not entirely reflect treatment effectiveness. Alternatively, patient-reported measures of function, disability, and health status may offer a unique and more reliable assessment of provider quality and performance,” she explained. Yet despite growing interest in using patient-reported measures, many important questions regarding their accuracy, applicability, and clinical utility remain. The purpose of this study was, therefore, to evaluate how patient-reported quality of life measures compared to short-term and long-term clinical outcomes in patients who underwent bariatric surgery.

©Vasilis Varsakelis/fotolia.com

The majority of the study’s 11,420 participants were female (79.8%), were white (84.1%), and underwent Roux-en-Y laparoscopic gastric bypass (56.8%). For each study participant, both short-term and long-term clinical outcome measures were obtained from medical board review. Short-term clinical outcomes were defined as the rate of perioperative complications within 30 days of bariatric surgery. Percent excess weight loss at 1 year post surgery was used as a long-term clinical outcome.

In addition, two patient-reported outcomes were collected: an overall health-related quality of life score called the Health and Activities Limitations Index (HALex) and an obesity-specific quality of life score, the Bariatric Quality of Life (BQL) index, which measures well-being, social and physical functioning, and obesity-related symptoms.

Multivariate and linear regression models demonstrated that short-term complication rates were not correlated to the overall patient-reported quality of life score (P = .32) or to the obesity-specific BQL score (P = .74).

However, the long-term measure of excess weight loss at 1 year post surgery was significantly associated with both overall and obesity-specific patient-reported measures of health-related quality of life (P less than .002 and P less than .001 respectively).

Moreover, scores indicating improved quality of life were associated with greater weight loss.

Finally, comorbidity resolution, estimated by the reduction in the use of medications taken to treat conditions related to obesity, was significantly associated with the obesity-specific measure, BQL, but not the overall quality of life measure, HALex.

“In conclusion, [patient-reported outcomes] are distinct from clinical outcomes,” investigators wrote. Patient-reported outcomes “provide an opportunity for improved population-based cost-effectiveness analyses using outcomes germane to procedures performed for symptomatology and improving QOL,” they added.

The Agency for Healthcare Research and Quality supported the research. The investigators reported having no disclosures.

[email protected]

On Twitter @jessnicolecraig

Overall, the response to Blue Ribbon Panel recommendations for guiding the Cancer Moonshot initiative were well received, though some patient advocates say a few key issues were overlooked.

In early September 2016, the Blue Ribbon Panel, a group of more than 150 scientists, clinicians, patient advocates, and industry representatives convened by the National Cancer Institutes’s National Cancer Advisory Board, published its Top 10 recommendations to guide future endeavors of the Cancer Moonshot Initiative.

The recommendations, which were informed by input from the research community and the public, emphasized “the importance of direct patient engagement in cancer research, a deeper understanding of why some therapies work and others do not, the dynamics of tumor evolution, and the need for mechanisms of data sharing, access, and analysis,” wrote Dinah S. Singer, PhD, and two other cochairs of the Blue Ribbon Panel in an article published in Science (2016 Sep 7. doi: 10.1126/science.aai7862).

“The recommendations that were announced today by the Cancer Moonshot Blue Ribbon Panel are vitally important to accomplishing the goal of the National Cancer Moonshot Initiative, which is to achieve a decade’s worth of advances in five years,” wrote American Association for Cancer Research President Nancy E. Davidson, MD, in a statement.

“The panel’s thoughtful work makes an important contribution to the Cancer Moonshot Initiative,” wrote American Society for Clinical Oncology President Daniel F. Hayes, MD, in a statement. In an interview, Dr. Hayes added that innovations in information technology and the focus on improving interoperability of electronic health records were two important strengths of the recommendations that will be “critically important to deliver high-quality, high-value oncology services to individuals with cancer.”

Michelle Esser, senior program manager at the Young Survival Coalition (YSC), agreed that the recommendations are good initial steps. However, she pointed out two issues that the recommendations overlooked. “First, is the lack of mention or understanding of the adolescent and young adult (AYA) oncology patient population,” Ms. Esser noted during an interview. “The report specifically called out pediatric cancer as an area of needed research, but AYAs, whose survival rates lag behind those of older and younger patients with a similar diagnosis, and for whom cancer is the leading cause of disease-related death, were not mentioned.”

Second, there was little mention of cancer metastasis, she said. “It is not an early-stage cancer diagnosis that kills, it is when cancer metastasizes and spreads that it becomes deadly. Out of the 10 recommendations only 1 mentions metastasis. If we want to make a difference in cancer outcomes, there needs to be focus on understanding why metastasis occurs, how to prevent it, and how to cure it.”

In order for these recommendations to really expedite the nation’s progress against cancer, “It is crucial that Congress provide the necessary funding to support the priority projects identified by the Blue Ribbon Panel and those we will hear about from the Task Force and Vice President’s Executive Reports later this year,” reported Dr. Hayes, a sentiment echoed by Dr. Davidson.

[email protected]

On Twitter @jessnicolecraig

Overall, the response to Blue Ribbon Panel recommendations for guiding the Cancer Moonshot initiative were well received, though some patient advocates say a few key issues were overlooked.

In early September 2016, the Blue Ribbon Panel, a group of more than 150 scientists, clinicians, patient advocates, and industry representatives convened by the National Cancer Institutes’s National Cancer Advisory Board, published its Top 10 recommendations to guide future endeavors of the Cancer Moonshot Initiative.

The recommendations, which were informed by input from the research community and the public, emphasized “the importance of direct patient engagement in cancer research, a deeper understanding of why some therapies work and others do not, the dynamics of tumor evolution, and the need for mechanisms of data sharing, access, and analysis,” wrote Dinah S. Singer, PhD, and two other cochairs of the Blue Ribbon Panel in an article published in Science (2016 Sep 7. doi: 10.1126/science.aai7862).

“The recommendations that were announced today by the Cancer Moonshot Blue Ribbon Panel are vitally important to accomplishing the goal of the National Cancer Moonshot Initiative, which is to achieve a decade’s worth of advances in five years,” wrote American Association for Cancer Research President Nancy E. Davidson, MD, in a statement.

“The panel’s thoughtful work makes an important contribution to the Cancer Moonshot Initiative,” wrote American Society for Clinical Oncology President Daniel F. Hayes, MD, in a statement. In an interview, Dr. Hayes added that innovations in information technology and the focus on improving interoperability of electronic health records were two important strengths of the recommendations that will be “critically important to deliver high-quality, high-value oncology services to individuals with cancer.”

Michelle Esser, senior program manager at the Young Survival Coalition (YSC), agreed that the recommendations are good initial steps. However, she pointed out two issues that the recommendations overlooked. “First, is the lack of mention or understanding of the adolescent and young adult (AYA) oncology patient population,” Ms. Esser noted during an interview. “The report specifically called out pediatric cancer as an area of needed research, but AYAs, whose survival rates lag behind those of older and younger patients with a similar diagnosis, and for whom cancer is the leading cause of disease-related death, were not mentioned.”

Second, there was little mention of cancer metastasis, she said. “It is not an early-stage cancer diagnosis that kills, it is when cancer metastasizes and spreads that it becomes deadly. Out of the 10 recommendations only 1 mentions metastasis. If we want to make a difference in cancer outcomes, there needs to be focus on understanding why metastasis occurs, how to prevent it, and how to cure it.”

In order for these recommendations to really expedite the nation’s progress against cancer, “It is crucial that Congress provide the necessary funding to support the priority projects identified by the Blue Ribbon Panel and those we will hear about from the Task Force and Vice President’s Executive Reports later this year,” reported Dr. Hayes, a sentiment echoed by Dr. Davidson.

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On Twitter @jessnicolecraig

Overall, the response to Blue Ribbon Panel recommendations for guiding the Cancer Moonshot initiative were well received, though some patient advocates say a few key issues were overlooked.

In early September 2016, the Blue Ribbon Panel, a group of more than 150 scientists, clinicians, patient advocates, and industry representatives convened by the National Cancer Institutes’s National Cancer Advisory Board, published its Top 10 recommendations to guide future endeavors of the Cancer Moonshot Initiative.

The recommendations, which were informed by input from the research community and the public, emphasized “the importance of direct patient engagement in cancer research, a deeper understanding of why some therapies work and others do not, the dynamics of tumor evolution, and the need for mechanisms of data sharing, access, and analysis,” wrote Dinah S. Singer, PhD, and two other cochairs of the Blue Ribbon Panel in an article published in Science (2016 Sep 7. doi: 10.1126/science.aai7862).

“The recommendations that were announced today by the Cancer Moonshot Blue Ribbon Panel are vitally important to accomplishing the goal of the National Cancer Moonshot Initiative, which is to achieve a decade’s worth of advances in five years,” wrote American Association for Cancer Research President Nancy E. Davidson, MD, in a statement.

“The panel’s thoughtful work makes an important contribution to the Cancer Moonshot Initiative,” wrote American Society for Clinical Oncology President Daniel F. Hayes, MD, in a statement. In an interview, Dr. Hayes added that innovations in information technology and the focus on improving interoperability of electronic health records were two important strengths of the recommendations that will be “critically important to deliver high-quality, high-value oncology services to individuals with cancer.”

Michelle Esser, senior program manager at the Young Survival Coalition (YSC), agreed that the recommendations are good initial steps. However, she pointed out two issues that the recommendations overlooked. “First, is the lack of mention or understanding of the adolescent and young adult (AYA) oncology patient population,” Ms. Esser noted during an interview. “The report specifically called out pediatric cancer as an area of needed research, but AYAs, whose survival rates lag behind those of older and younger patients with a similar diagnosis, and for whom cancer is the leading cause of disease-related death, were not mentioned.”

Second, there was little mention of cancer metastasis, she said. “It is not an early-stage cancer diagnosis that kills, it is when cancer metastasizes and spreads that it becomes deadly. Out of the 10 recommendations only 1 mentions metastasis. If we want to make a difference in cancer outcomes, there needs to be focus on understanding why metastasis occurs, how to prevent it, and how to cure it.”

In order for these recommendations to really expedite the nation’s progress against cancer, “It is crucial that Congress provide the necessary funding to support the priority projects identified by the Blue Ribbon Panel and those we will hear about from the Task Force and Vice President’s Executive Reports later this year,” reported Dr. Hayes, a sentiment echoed by Dr. Davidson.

[email protected]

On Twitter @jessnicolecraig

There is increased anxiety and depression among family caregivers who do not take care of themselves, according to a study to be presented at the 2016 ASCO Palliative Care in Oncology Symposium.

Nearly a quarter of 294 caregivers of Medicare patients with advanced cancer reported high depression scores (23%) and 34% reported borderline or high anxiety scores. Worse caregiver anxiety, depression, and mental health–related quality of life scores were significantly associated with lower scores in every self-care measure (P less than .05 for all). Lower self-care behavior scores were associated with longer durations, higher hours, and more days/week of caregiving and with fair or poor patient health.

The cross-sectional survey was conducted in community settings of eight cancer centers in Alabama, Florida, and Tennessee. The family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head & neck, hematologic, or stage IV cancer completed measures of self-care behaviors, including health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, stress management, and sleep. Caregivers averaged 66 years and were mostly female (72.8%), white (91.2%), Protestant (76.2%), retired (54.4%), and patients’ spouse/partner (60.2%). Approximately half were rural dwellers (46.9%) and had incomes less than $50,000 (53.8%). The majority provided support 6-7 days per week (71%) for greater than 1 year (68%).

“This research serves as an important call to action for the oncology community to implement support networks and services that care for the caregiver,” ASCO representative Andrew Epstein, MD, of Memorial Sloan Kettering Cancer Center, New York, said in a written statement ahead of the symposium.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” lead author James Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham, said in the statement.

[email protected]

On Twitter @jessnicolecraig

There is increased anxiety and depression among family caregivers who do not take care of themselves, according to a study to be presented at the 2016 ASCO Palliative Care in Oncology Symposium.

Nearly a quarter of 294 caregivers of Medicare patients with advanced cancer reported high depression scores (23%) and 34% reported borderline or high anxiety scores. Worse caregiver anxiety, depression, and mental health–related quality of life scores were significantly associated with lower scores in every self-care measure (P less than .05 for all). Lower self-care behavior scores were associated with longer durations, higher hours, and more days/week of caregiving and with fair or poor patient health.

The cross-sectional survey was conducted in community settings of eight cancer centers in Alabama, Florida, and Tennessee. The family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head & neck, hematologic, or stage IV cancer completed measures of self-care behaviors, including health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, stress management, and sleep. Caregivers averaged 66 years and were mostly female (72.8%), white (91.2%), Protestant (76.2%), retired (54.4%), and patients’ spouse/partner (60.2%). Approximately half were rural dwellers (46.9%) and had incomes less than $50,000 (53.8%). The majority provided support 6-7 days per week (71%) for greater than 1 year (68%).

“This research serves as an important call to action for the oncology community to implement support networks and services that care for the caregiver,” ASCO representative Andrew Epstein, MD, of Memorial Sloan Kettering Cancer Center, New York, said in a written statement ahead of the symposium.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” lead author James Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham, said in the statement.

[email protected]

On Twitter @jessnicolecraig

There is increased anxiety and depression among family caregivers who do not take care of themselves, according to a study to be presented at the 2016 ASCO Palliative Care in Oncology Symposium.

Nearly a quarter of 294 caregivers of Medicare patients with advanced cancer reported high depression scores (23%) and 34% reported borderline or high anxiety scores. Worse caregiver anxiety, depression, and mental health–related quality of life scores were significantly associated with lower scores in every self-care measure (P less than .05 for all). Lower self-care behavior scores were associated with longer durations, higher hours, and more days/week of caregiving and with fair or poor patient health.

The cross-sectional survey was conducted in community settings of eight cancer centers in Alabama, Florida, and Tennessee. The family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head & neck, hematologic, or stage IV cancer completed measures of self-care behaviors, including health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, stress management, and sleep. Caregivers averaged 66 years and were mostly female (72.8%), white (91.2%), Protestant (76.2%), retired (54.4%), and patients’ spouse/partner (60.2%). Approximately half were rural dwellers (46.9%) and had incomes less than $50,000 (53.8%). The majority provided support 6-7 days per week (71%) for greater than 1 year (68%).

“This research serves as an important call to action for the oncology community to implement support networks and services that care for the caregiver,” ASCO representative Andrew Epstein, MD, of Memorial Sloan Kettering Cancer Center, New York, said in a written statement ahead of the symposium.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” lead author James Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham, said in the statement.

[email protected]

On Twitter @jessnicolecraig

No marketed screening test has been clinically proven to accurately diagnose ovarian cancer, according to a MedWatch announcement from the Food and Drug Administration.

Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results,” FDA officials said in a statement.

Officials with the American Congress of Obstetricians and Gynecologists echoed the FDA’s concern, pointing out that several ovarian cancer screening tests, including the CA-125 test and the Risk of Ovarian Cancer Algorithm test, are currently available and claim to detect ovarian cancer before symptoms occur. These claims are “not based on data,” ACOG president Thomas Gellhaus, MD, said in a statement.

The FDA and ACOG both expressed concern that the use of these tests could delay treatment for asymptomatic women with early-stage ovarian cancer and also may result in unnecessary medical procedures for women who receive positive test results even though no cancer is present.

“Using unproven ovarian cancer screening tests also may be harmful for women with increased risk for developing ovarian cancer,” the FDA wrote and added that “women at high risk for developing ovarian cancer should not use any currently offered test that claims to screen for ovarian cancer.”

Instead, women at high risk of developing ovarian cancer, including those with BRCA mutations, should be referred to a genetic counselor, gynecologic oncologist, or other appropriate health care provider for more specialized care, the FDA recommended. “Currently, it appears that the best way to detect ovarian cancer is for both the patient and her clinician to have a high index of suspicion of the diagnosis in symptomatic women. Persistent and progressive symptoms, such as an increase in bloating, pelvic or abdominal pain, or difficulty eating or feeling full quickly, should be evaluated,” Dr. Gellhaus added.

[email protected]

On Twitter @jessnicolecraig

No marketed screening test has been clinically proven to accurately diagnose ovarian cancer, according to a MedWatch announcement from the Food and Drug Administration.

Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results,” FDA officials said in a statement.

Officials with the American Congress of Obstetricians and Gynecologists echoed the FDA’s concern, pointing out that several ovarian cancer screening tests, including the CA-125 test and the Risk of Ovarian Cancer Algorithm test, are currently available and claim to detect ovarian cancer before symptoms occur. These claims are “not based on data,” ACOG president Thomas Gellhaus, MD, said in a statement.

The FDA and ACOG both expressed concern that the use of these tests could delay treatment for asymptomatic women with early-stage ovarian cancer and also may result in unnecessary medical procedures for women who receive positive test results even though no cancer is present.

“Using unproven ovarian cancer screening tests also may be harmful for women with increased risk for developing ovarian cancer,” the FDA wrote and added that “women at high risk for developing ovarian cancer should not use any currently offered test that claims to screen for ovarian cancer.”

Instead, women at high risk of developing ovarian cancer, including those with BRCA mutations, should be referred to a genetic counselor, gynecologic oncologist, or other appropriate health care provider for more specialized care, the FDA recommended. “Currently, it appears that the best way to detect ovarian cancer is for both the patient and her clinician to have a high index of suspicion of the diagnosis in symptomatic women. Persistent and progressive symptoms, such as an increase in bloating, pelvic or abdominal pain, or difficulty eating or feeling full quickly, should be evaluated,” Dr. Gellhaus added.

[email protected]

On Twitter @jessnicolecraig

No marketed screening test has been clinically proven to accurately diagnose ovarian cancer, according to a MedWatch announcement from the Food and Drug Administration.

Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results,” FDA officials said in a statement.

Officials with the American Congress of Obstetricians and Gynecologists echoed the FDA’s concern, pointing out that several ovarian cancer screening tests, including the CA-125 test and the Risk of Ovarian Cancer Algorithm test, are currently available and claim to detect ovarian cancer before symptoms occur. These claims are “not based on data,” ACOG president Thomas Gellhaus, MD, said in a statement.

The FDA and ACOG both expressed concern that the use of these tests could delay treatment for asymptomatic women with early-stage ovarian cancer and also may result in unnecessary medical procedures for women who receive positive test results even though no cancer is present.

“Using unproven ovarian cancer screening tests also may be harmful for women with increased risk for developing ovarian cancer,” the FDA wrote and added that “women at high risk for developing ovarian cancer should not use any currently offered test that claims to screen for ovarian cancer.”

Instead, women at high risk of developing ovarian cancer, including those with BRCA mutations, should be referred to a genetic counselor, gynecologic oncologist, or other appropriate health care provider for more specialized care, the FDA recommended. “Currently, it appears that the best way to detect ovarian cancer is for both the patient and her clinician to have a high index of suspicion of the diagnosis in symptomatic women. Persistent and progressive symptoms, such as an increase in bloating, pelvic or abdominal pain, or difficulty eating or feeling full quickly, should be evaluated,” Dr. Gellhaus added.

[email protected]

On Twitter @jessnicolecraig

Duration of illness, age, and the presence of specific symptoms are key predictors of hospitalization risk due to respiratory infection, according to a study published in The Lancet. These demographic and clinical factors should guide a primary care physician’s decision to prescribe antibiotics.

“More than 80% of all health-service antibiotics [are] prescribed by primary care clinicians,” reported Alastair Hay, MD, of the University of Bristol, England, and his associates.

“Antibiotic prescribing in primary care is increasing and directly affects antimicrobial resistance,” the researchers noted, adding that many primary care clinicians prescribe antibiotics to pediatric patients with respiratory tract infections and/or cough to “mitigate perceived risk of future hospital admission and complications.”

A total of 8,394 pediatric patients who presented with acute cough and one or more other symptoms of respiratory tract infection (such as fever and coryza) were enrolled in the study by primary care physicians at 247 clinical sites in England. All eligible patients were between the ages of 3 months and 16 years; children were excluded if they presented with noninfective exacerbation of asthma, were at high risk of serious infection, or required a throat swab. The study’s primary outcome was hospital admission for any respiratory tract infection within 30 days of enrollment; the data were collected from a review of electronic medical records (Lancet. 2016. Sept 1. doi: 10.1016/S2213-2600[16]30223-5).

©Ryan McVay/ thinkstockphotos.com

The median age of the pediatric cohort was 3 years, 52% were male, and 78% were white. A total of 3,121 patients (37%) were prescribed an antibiotic by their primary care physicians, but only 78 patients (0.9%) were admitted to the hospital, and 27% of discharge diagnoses suggested a possible bacterial cause (lower respiratory tract infection, tonsillitis, and pneumonia).

Multivariate modeling with bootstrap validation demonstrated that duration of illness, age, and the presence or absence of specific respiratory symptoms were the key factors that should be used to identify children at low, normal, and high risk for hospitalization due to respiratory infection. Younger patients with shorter illness durations who presented with wheeze, fever, vomiting, intercostal or subcostal recession, and/or asthma were at higher risk for hospitalization.

“Our data show that 1,846 (33%) of the very-low-risk stratum children received antibiotics. Because these children represent the majority (67%) of all the participants, a 10% overall reduction in antibiotic prescription would be achieved if prescription in this group halved, remained static in the normal risk stratum, and increased to 90% in the high risk stratum, resulting in a similar effect size to other contemporary antimicrobial stewardship interventions,” Dr. Hay and his associates concluded.

This study received funding and sponsorship from the National Institute for Health Research and the University of Bristol. Two investigators reported receiving financial compensation or honoraria from multiple companies including companies with an interest in diagnostic microbiology in respiratory tract infections.

[email protected]

On Twitter @jessnicolecraig

Duration of illness, age, and the presence of specific symptoms are key predictors of hospitalization risk due to respiratory infection, according to a study published in The Lancet. These demographic and clinical factors should guide a primary care physician’s decision to prescribe antibiotics.

“More than 80% of all health-service antibiotics [are] prescribed by primary care clinicians,” reported Alastair Hay, MD, of the University of Bristol, England, and his associates.

“Antibiotic prescribing in primary care is increasing and directly affects antimicrobial resistance,” the researchers noted, adding that many primary care clinicians prescribe antibiotics to pediatric patients with respiratory tract infections and/or cough to “mitigate perceived risk of future hospital admission and complications.”

A total of 8,394 pediatric patients who presented with acute cough and one or more other symptoms of respiratory tract infection (such as fever and coryza) were enrolled in the study by primary care physicians at 247 clinical sites in England. All eligible patients were between the ages of 3 months and 16 years; children were excluded if they presented with noninfective exacerbation of asthma, were at high risk of serious infection, or required a throat swab. The study’s primary outcome was hospital admission for any respiratory tract infection within 30 days of enrollment; the data were collected from a review of electronic medical records (Lancet. 2016. Sept 1. doi: 10.1016/S2213-2600[16]30223-5).

©Ryan McVay/ thinkstockphotos.com

The median age of the pediatric cohort was 3 years, 52% were male, and 78% were white. A total of 3,121 patients (37%) were prescribed an antibiotic by their primary care physicians, but only 78 patients (0.9%) were admitted to the hospital, and 27% of discharge diagnoses suggested a possible bacterial cause (lower respiratory tract infection, tonsillitis, and pneumonia).

Multivariate modeling with bootstrap validation demonstrated that duration of illness, age, and the presence or absence of specific respiratory symptoms were the key factors that should be used to identify children at low, normal, and high risk for hospitalization due to respiratory infection. Younger patients with shorter illness durations who presented with wheeze, fever, vomiting, intercostal or subcostal recession, and/or asthma were at higher risk for hospitalization.

“Our data show that 1,846 (33%) of the very-low-risk stratum children received antibiotics. Because these children represent the majority (67%) of all the participants, a 10% overall reduction in antibiotic prescription would be achieved if prescription in this group halved, remained static in the normal risk stratum, and increased to 90% in the high risk stratum, resulting in a similar effect size to other contemporary antimicrobial stewardship interventions,” Dr. Hay and his associates concluded.

This study received funding and sponsorship from the National Institute for Health Research and the University of Bristol. Two investigators reported receiving financial compensation or honoraria from multiple companies including companies with an interest in diagnostic microbiology in respiratory tract infections.

[email protected]

On Twitter @jessnicolecraig

Duration of illness, age, and the presence of specific symptoms are key predictors of hospitalization risk due to respiratory infection, according to a study published in The Lancet. These demographic and clinical factors should guide a primary care physician’s decision to prescribe antibiotics.

“More than 80% of all health-service antibiotics [are] prescribed by primary care clinicians,” reported Alastair Hay, MD, of the University of Bristol, England, and his associates.

“Antibiotic prescribing in primary care is increasing and directly affects antimicrobial resistance,” the researchers noted, adding that many primary care clinicians prescribe antibiotics to pediatric patients with respiratory tract infections and/or cough to “mitigate perceived risk of future hospital admission and complications.”

A total of 8,394 pediatric patients who presented with acute cough and one or more other symptoms of respiratory tract infection (such as fever and coryza) were enrolled in the study by primary care physicians at 247 clinical sites in England. All eligible patients were between the ages of 3 months and 16 years; children were excluded if they presented with noninfective exacerbation of asthma, were at high risk of serious infection, or required a throat swab. The study’s primary outcome was hospital admission for any respiratory tract infection within 30 days of enrollment; the data were collected from a review of electronic medical records (Lancet. 2016. Sept 1. doi: 10.1016/S2213-2600[16]30223-5).

©Ryan McVay/ thinkstockphotos.com

The median age of the pediatric cohort was 3 years, 52% were male, and 78% were white. A total of 3,121 patients (37%) were prescribed an antibiotic by their primary care physicians, but only 78 patients (0.9%) were admitted to the hospital, and 27% of discharge diagnoses suggested a possible bacterial cause (lower respiratory tract infection, tonsillitis, and pneumonia).

Multivariate modeling with bootstrap validation demonstrated that duration of illness, age, and the presence or absence of specific respiratory symptoms were the key factors that should be used to identify children at low, normal, and high risk for hospitalization due to respiratory infection. Younger patients with shorter illness durations who presented with wheeze, fever, vomiting, intercostal or subcostal recession, and/or asthma were at higher risk for hospitalization.

“Our data show that 1,846 (33%) of the very-low-risk stratum children received antibiotics. Because these children represent the majority (67%) of all the participants, a 10% overall reduction in antibiotic prescription would be achieved if prescription in this group halved, remained static in the normal risk stratum, and increased to 90% in the high risk stratum, resulting in a similar effect size to other contemporary antimicrobial stewardship interventions,” Dr. Hay and his associates concluded.

This study received funding and sponsorship from the National Institute for Health Research and the University of Bristol. Two investigators reported receiving financial compensation or honoraria from multiple companies including companies with an interest in diagnostic microbiology in respiratory tract infections.

[email protected]

On Twitter @jessnicolecraig

Incidence rates for localized- and regional-stage prostate cancer continued to decline 2 years following the recommendation by the U.S. Preventive Services Task Force against prostate-specific antigen (PSA) testing in all men.

“Convincing evidence demonstrates that the PSA test often produces false-positive results [and] false-positive PSA test results are associated with negative psychological effects, including persistent worry about prostate cancer,” the task force stated in a recommendation published in October 2011 and finalized in May 2012.

From 2011 to 2012, immediately following the recommendation, there was a significant decline in early-stage cancer incidence rates among men 50 years or older, according to an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) program.

For the current study, Ahmedin Jemal, DVM, PhD, and his associates at the American Cancer Society analyzed incidence data for invasive prostate cancer from 18 SEER registries, which, combined, represented about 28% of the U.S. population.

Investigators reported a continued decline in localized- and regional-stage prostate cancer incidence from 2012 to 2013. Specifically, the incidence rates per 100,000 men decreased from 356.5 to 335.4 in men aged 50-74 years and from 379.2 to 353.6 in men 75 years and older (JAMA Oncol. 2016 Aug 16. doi: 10.1001/jamaoncol.2016.2667).

Incidence rates for distant-stage disease were unchanged during the same time period for men of all ages.

Similar results were reported for non-Hispanic whites and non-Hispanic blacks.

“Whether this pattern will lead to a future increase in the diagnosis of distant-stage disease and prostate cancer mortality requires long-term monitoring because of the slow growing nature of this malignant neoplasm,” the investigators noted.

The American Cancer Society funded the study. The authors had no relevant disclosures to report.

[email protected]

On Twitter @jessnicolecraig

Incidence rates for localized- and regional-stage prostate cancer continued to decline 2 years following the recommendation by the U.S. Preventive Services Task Force against prostate-specific antigen (PSA) testing in all men.

“Convincing evidence demonstrates that the PSA test often produces false-positive results [and] false-positive PSA test results are associated with negative psychological effects, including persistent worry about prostate cancer,” the task force stated in a recommendation published in October 2011 and finalized in May 2012.

From 2011 to 2012, immediately following the recommendation, there was a significant decline in early-stage cancer incidence rates among men 50 years or older, according to an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) program.

For the current study, Ahmedin Jemal, DVM, PhD, and his associates at the American Cancer Society analyzed incidence data for invasive prostate cancer from 18 SEER registries, which, combined, represented about 28% of the U.S. population.

Investigators reported a continued decline in localized- and regional-stage prostate cancer incidence from 2012 to 2013. Specifically, the incidence rates per 100,000 men decreased from 356.5 to 335.4 in men aged 50-74 years and from 379.2 to 353.6 in men 75 years and older (JAMA Oncol. 2016 Aug 16. doi: 10.1001/jamaoncol.2016.2667).

Incidence rates for distant-stage disease were unchanged during the same time period for men of all ages.

Similar results were reported for non-Hispanic whites and non-Hispanic blacks.

“Whether this pattern will lead to a future increase in the diagnosis of distant-stage disease and prostate cancer mortality requires long-term monitoring because of the slow growing nature of this malignant neoplasm,” the investigators noted.

The American Cancer Society funded the study. The authors had no relevant disclosures to report.

[email protected]

On Twitter @jessnicolecraig

Incidence rates for localized- and regional-stage prostate cancer continued to decline 2 years following the recommendation by the U.S. Preventive Services Task Force against prostate-specific antigen (PSA) testing in all men.

“Convincing evidence demonstrates that the PSA test often produces false-positive results [and] false-positive PSA test results are associated with negative psychological effects, including persistent worry about prostate cancer,” the task force stated in a recommendation published in October 2011 and finalized in May 2012.

From 2011 to 2012, immediately following the recommendation, there was a significant decline in early-stage cancer incidence rates among men 50 years or older, according to an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) program.

For the current study, Ahmedin Jemal, DVM, PhD, and his associates at the American Cancer Society analyzed incidence data for invasive prostate cancer from 18 SEER registries, which, combined, represented about 28% of the U.S. population.

Investigators reported a continued decline in localized- and regional-stage prostate cancer incidence from 2012 to 2013. Specifically, the incidence rates per 100,000 men decreased from 356.5 to 335.4 in men aged 50-74 years and from 379.2 to 353.6 in men 75 years and older (JAMA Oncol. 2016 Aug 16. doi: 10.1001/jamaoncol.2016.2667).

Incidence rates for distant-stage disease were unchanged during the same time period for men of all ages.

Similar results were reported for non-Hispanic whites and non-Hispanic blacks.

“Whether this pattern will lead to a future increase in the diagnosis of distant-stage disease and prostate cancer mortality requires long-term monitoring because of the slow growing nature of this malignant neoplasm,” the investigators noted.

The American Cancer Society funded the study. The authors had no relevant disclosures to report.

[email protected]

On Twitter @jessnicolecraig

Obese patients who underwent Roux-en-Y gastric bypass had higher percentages of weight loss at long-term follow-up, compared with obese patients who underwent other surgical procedures or who did not undergo surgery, according to a large, cohort study published in JAMA Surgery.

While prior research has clearly demonstrated that bariatric surgery is the most effective intervention for inducing weight loss among obese patients, the majority of those studies were short term; therefore, there is little known about the durability of weight loss following bariatric surgery, wrote Matthew Maciejewski, PhD, of Duke University, Durham, N.C., and Durham Veterans Affairs Medical Center and his associates.

This study compared the 10-year weight change in patients who underwent Roux-en-Y gastric bypass to patients who did not receive bariatric surgical intervention of any kind. A total of 1,787 patients who had undergone Roux-en-Y gastric bypass surgery were identified and matched by investigators to one or more patients with similar demographic characteristics (age, sex, race, body mass index, diabetes diagnosis). A total of 5,305 nonsurgical matches were selected for analysis. For the Roux-en-Y gastric bypass group, mean age was 52.1 years, and for the nonsurgical matches mean age was 52.2 years. Both groups were predominantly male (73.1% and 73.7%, respectively) and had high 10-year follow-up rates of 81.9% for surgical patients and 67.4% for nonsurgical matches (JAMA Surgery. 2016. doi: 10.1001/jamasurg.2016.2317).

The study’s primary outcome of percentage change in weight at 10-year follow-up, compared with baseline strongly favored Roux-en-Y gastric bypass over no surgical intervention. At the 10-year time point, patients who underwent Roux-en-Y gastric bypass had lost 21.3% more of their baseline weight than nonsurgical matches.

Remarkably, only 3.4% of patients who underwent Roux-en-Y gastric bypass were within 5% of their original baseline weight at 10 years while 55.5% of those who did not receive surgical intervention had regained most of their weight.

Additionally, investigators compared percentage change in weight at 4-year follow-up for obese patients who underwent either Roux-en-Y gastric bypass (n = 1,785), sleeve gastrectomy (n = 379), or adjustable gastric banding (n = 246). At this time point, patients who underwent Roux-en-Y gastric bypass had lost an average of 28% of their baseline weight while patients who underwent sleeve gastrectomy or adjustable gastric banding only lost 18% and 11% of their baseline weights, respectively.

“These results provide further evidence for the beneficial association between surgery and long-term weight loss that has been demonstrated in shorter-term studies of younger, predominantly female populations,” the investigators concluded.

This study was funded by the Department of Veterans Affairs. Dr. Maciejewski and four of his associates reported receiving financial compensation from or holding stock in various companies and institutions including the Department of Veterans Affairs.

[email protected]

On Twitter @jessnicolecraig

Obese patients who underwent Roux-en-Y gastric bypass had higher percentages of weight loss at long-term follow-up, compared with obese patients who underwent other surgical procedures or who did not undergo surgery, according to a large, cohort study published in JAMA Surgery.

While prior research has clearly demonstrated that bariatric surgery is the most effective intervention for inducing weight loss among obese patients, the majority of those studies were short term; therefore, there is little known about the durability of weight loss following bariatric surgery, wrote Matthew Maciejewski, PhD, of Duke University, Durham, N.C., and Durham Veterans Affairs Medical Center and his associates.

This study compared the 10-year weight change in patients who underwent Roux-en-Y gastric bypass to patients who did not receive bariatric surgical intervention of any kind. A total of 1,787 patients who had undergone Roux-en-Y gastric bypass surgery were identified and matched by investigators to one or more patients with similar demographic characteristics (age, sex, race, body mass index, diabetes diagnosis). A total of 5,305 nonsurgical matches were selected for analysis. For the Roux-en-Y gastric bypass group, mean age was 52.1 years, and for the nonsurgical matches mean age was 52.2 years. Both groups were predominantly male (73.1% and 73.7%, respectively) and had high 10-year follow-up rates of 81.9% for surgical patients and 67.4% for nonsurgical matches (JAMA Surgery. 2016. doi: 10.1001/jamasurg.2016.2317).

The study’s primary outcome of percentage change in weight at 10-year follow-up, compared with baseline strongly favored Roux-en-Y gastric bypass over no surgical intervention. At the 10-year time point, patients who underwent Roux-en-Y gastric bypass had lost 21.3% more of their baseline weight than nonsurgical matches.

Remarkably, only 3.4% of patients who underwent Roux-en-Y gastric bypass were within 5% of their original baseline weight at 10 years while 55.5% of those who did not receive surgical intervention had regained most of their weight.

Additionally, investigators compared percentage change in weight at 4-year follow-up for obese patients who underwent either Roux-en-Y gastric bypass (n = 1,785), sleeve gastrectomy (n = 379), or adjustable gastric banding (n = 246). At this time point, patients who underwent Roux-en-Y gastric bypass had lost an average of 28% of their baseline weight while patients who underwent sleeve gastrectomy or adjustable gastric banding only lost 18% and 11% of their baseline weights, respectively.

“These results provide further evidence for the beneficial association between surgery and long-term weight loss that has been demonstrated in shorter-term studies of younger, predominantly female populations,” the investigators concluded.

This study was funded by the Department of Veterans Affairs. Dr. Maciejewski and four of his associates reported receiving financial compensation from or holding stock in various companies and institutions including the Department of Veterans Affairs.

[email protected]

On Twitter @jessnicolecraig

Obese patients who underwent Roux-en-Y gastric bypass had higher percentages of weight loss at long-term follow-up, compared with obese patients who underwent other surgical procedures or who did not undergo surgery, according to a large, cohort study published in JAMA Surgery.

While prior research has clearly demonstrated that bariatric surgery is the most effective intervention for inducing weight loss among obese patients, the majority of those studies were short term; therefore, there is little known about the durability of weight loss following bariatric surgery, wrote Matthew Maciejewski, PhD, of Duke University, Durham, N.C., and Durham Veterans Affairs Medical Center and his associates.

This study compared the 10-year weight change in patients who underwent Roux-en-Y gastric bypass to patients who did not receive bariatric surgical intervention of any kind. A total of 1,787 patients who had undergone Roux-en-Y gastric bypass surgery were identified and matched by investigators to one or more patients with similar demographic characteristics (age, sex, race, body mass index, diabetes diagnosis). A total of 5,305 nonsurgical matches were selected for analysis. For the Roux-en-Y gastric bypass group, mean age was 52.1 years, and for the nonsurgical matches mean age was 52.2 years. Both groups were predominantly male (73.1% and 73.7%, respectively) and had high 10-year follow-up rates of 81.9% for surgical patients and 67.4% for nonsurgical matches (JAMA Surgery. 2016. doi: 10.1001/jamasurg.2016.2317).

The study’s primary outcome of percentage change in weight at 10-year follow-up, compared with baseline strongly favored Roux-en-Y gastric bypass over no surgical intervention. At the 10-year time point, patients who underwent Roux-en-Y gastric bypass had lost 21.3% more of their baseline weight than nonsurgical matches.

Remarkably, only 3.4% of patients who underwent Roux-en-Y gastric bypass were within 5% of their original baseline weight at 10 years while 55.5% of those who did not receive surgical intervention had regained most of their weight.

Additionally, investigators compared percentage change in weight at 4-year follow-up for obese patients who underwent either Roux-en-Y gastric bypass (n = 1,785), sleeve gastrectomy (n = 379), or adjustable gastric banding (n = 246). At this time point, patients who underwent Roux-en-Y gastric bypass had lost an average of 28% of their baseline weight while patients who underwent sleeve gastrectomy or adjustable gastric banding only lost 18% and 11% of their baseline weights, respectively.

“These results provide further evidence for the beneficial association between surgery and long-term weight loss that has been demonstrated in shorter-term studies of younger, predominantly female populations,” the investigators concluded.

This study was funded by the Department of Veterans Affairs. Dr. Maciejewski and four of his associates reported receiving financial compensation from or holding stock in various companies and institutions including the Department of Veterans Affairs.

[email protected]

On Twitter @jessnicolecraig

Avoid weight-based language, use motivational interviewing techniques, and promote healthy family-based lifestyle modifications to prevent and manage obesity without predisposing adolescents to eating disorders, according to new recommendations in an American Academy of Pediatrics clinical report.

Obesity and eating disorders are becoming increasingly prevalent in adolescents. In 2012, 20.5% of 12- to 19-year-olds met sex-specific body mass index (BMI) criteria for obesity, according to data from the National Health and Nutrition Examination survey. From 1999 to 2006, there was a 119% increase in hospitalizations due to eating disorders among children younger than 12 years, according to a 2011 study by the Agency for Healthcare Research and Quality.

©moodboard/thinkstockphotos.com

Most adolescents who develop eating disorders are not obese, lead coauthor Neville H. Golden, MD, of Stanford (Calif.) University and his associates noted in the report by the AAP Committee on Nutrition, the Committee on Adolescence, and the Section on Obesity (Pediatrics. 2016 Aug. doi: 10.1542/peds.2016-1649).

However, in some adolescents, obesity prevention or management and initial attempts to lose weight can spiral into the development of an eating disorder, they said. “In one study in adolescents seeking treatment of an [eating disorder], 36.7% had a previous weight greater than the 85th percentile for age and sex.”

Cross-sectional and longitudinal observational studies identified dieting, body dissatisfaction, and talking about or teasing a child about his or her weight as risk factors for obesity and eating disorders. Conversely, family meals have been associated with improved dietary quality and a reduction in eating disorders among adolescent girls.

As pediatricians are often the first professional consulted by a parent when eating disorders or obesity are a concern, the investigators recommended the following office-based, evidence-informed tools to provide guidance about obesity and eating disorders:

• Discourage dieting, skipping of meals, or the use of diet pills.

• Encourage healthy eating and physical activity.

• Promote a positive body image; do not focus on body dissatisfaction as a reason for dieting.

• Encourage family meals.

• Encourage families not to talk about weight, but rather to talk about healthy eating and being active to stay healthy.

• Inquire about a history of mistreatment or bullying in overweight and obese teenagers and address this issue with patients and their families.

• Monitor weight loss in adolescents who need to lose weight.

The American Academy of Pediatrics supported this clinical report. The authors had no relevant disclosures to report.

[email protected]

On Twitter @jessnicolecraig

Avoid weight-based language, use motivational interviewing techniques, and promote healthy family-based lifestyle modifications to prevent and manage obesity without predisposing adolescents to eating disorders, according to new recommendations in an American Academy of Pediatrics clinical report.

Obesity and eating disorders are becoming increasingly prevalent in adolescents. In 2012, 20.5% of 12- to 19-year-olds met sex-specific body mass index (BMI) criteria for obesity, according to data from the National Health and Nutrition Examination survey. From 1999 to 2006, there was a 119% increase in hospitalizations due to eating disorders among children younger than 12 years, according to a 2011 study by the Agency for Healthcare Research and Quality.

©moodboard/thinkstockphotos.com

Most adolescents who develop eating disorders are not obese, lead coauthor Neville H. Golden, MD, of Stanford (Calif.) University and his associates noted in the report by the AAP Committee on Nutrition, the Committee on Adolescence, and the Section on Obesity (Pediatrics. 2016 Aug. doi: 10.1542/peds.2016-1649).

However, in some adolescents, obesity prevention or management and initial attempts to lose weight can spiral into the development of an eating disorder, they said. “In one study in adolescents seeking treatment of an [eating disorder], 36.7% had a previous weight greater than the 85th percentile for age and sex.”

Cross-sectional and longitudinal observational studies identified dieting, body dissatisfaction, and talking about or teasing a child about his or her weight as risk factors for obesity and eating disorders. Conversely, family meals have been associated with improved dietary quality and a reduction in eating disorders among adolescent girls.

As pediatricians are often the first professional consulted by a parent when eating disorders or obesity are a concern, the investigators recommended the following office-based, evidence-informed tools to provide guidance about obesity and eating disorders:

• Discourage dieting, skipping of meals, or the use of diet pills.

• Encourage healthy eating and physical activity.

• Promote a positive body image; do not focus on body dissatisfaction as a reason for dieting.

• Encourage family meals.

• Encourage families not to talk about weight, but rather to talk about healthy eating and being active to stay healthy.

• Inquire about a history of mistreatment or bullying in overweight and obese teenagers and address this issue with patients and their families.

• Monitor weight loss in adolescents who need to lose weight.

The American Academy of Pediatrics supported this clinical report. The authors had no relevant disclosures to report.

[email protected]

On Twitter @jessnicolecraig

Avoid weight-based language, use motivational interviewing techniques, and promote healthy family-based lifestyle modifications to prevent and manage obesity without predisposing adolescents to eating disorders, according to new recommendations in an American Academy of Pediatrics clinical report.

Obesity and eating disorders are becoming increasingly prevalent in adolescents. In 2012, 20.5% of 12- to 19-year-olds met sex-specific body mass index (BMI) criteria for obesity, according to data from the National Health and Nutrition Examination survey. From 1999 to 2006, there was a 119% increase in hospitalizations due to eating disorders among children younger than 12 years, according to a 2011 study by the Agency for Healthcare Research and Quality.

©moodboard/thinkstockphotos.com

Most adolescents who develop eating disorders are not obese, lead coauthor Neville H. Golden, MD, of Stanford (Calif.) University and his associates noted in the report by the AAP Committee on Nutrition, the Committee on Adolescence, and the Section on Obesity (Pediatrics. 2016 Aug. doi: 10.1542/peds.2016-1649).

However, in some adolescents, obesity prevention or management and initial attempts to lose weight can spiral into the development of an eating disorder, they said. “In one study in adolescents seeking treatment of an [eating disorder], 36.7% had a previous weight greater than the 85th percentile for age and sex.”

Cross-sectional and longitudinal observational studies identified dieting, body dissatisfaction, and talking about or teasing a child about his or her weight as risk factors for obesity and eating disorders. Conversely, family meals have been associated with improved dietary quality and a reduction in eating disorders among adolescent girls.

As pediatricians are often the first professional consulted by a parent when eating disorders or obesity are a concern, the investigators recommended the following office-based, evidence-informed tools to provide guidance about obesity and eating disorders:

• Discourage dieting, skipping of meals, or the use of diet pills.

• Encourage healthy eating and physical activity.

• Promote a positive body image; do not focus on body dissatisfaction as a reason for dieting.

• Encourage family meals.

• Encourage families not to talk about weight, but rather to talk about healthy eating and being active to stay healthy.

• Inquire about a history of mistreatment or bullying in overweight and obese teenagers and address this issue with patients and their families.

• Monitor weight loss in adolescents who need to lose weight.

The American Academy of Pediatrics supported this clinical report. The authors had no relevant disclosures to report.

[email protected]

On Twitter @jessnicolecraig