Sharon Worcester is an award-winning medical journalist for MDedge News. She has been with the company since 1996, first as the Southeast Bureau Chief (1996-2009) when the company was known as International Medical News Group, then as a freelance writer (2010-2015) before returning as a reporter in 2015. She previously worked as a daily newspaper reporter covering health and local government. Sharon currently reports primarily on oncology and hematology. She has a BA from Eckerd College and an MA in Mass Communication/Print Journalism from the University of Florida. Connect with her via LinkedIn and follow her on twitter @SW_MedReporter.

Combined Angiotensin Inhibition Raises Hyperkalemia, Acute Kidney Injury Risks

Finding marks end of dual RAAS blockade – for now
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Combined Angiotensin Inhibition Raises Hyperkalemia, Acute Kidney Injury Risks

ATLANTA – The combined use of an angiotensin-converting enzyme inhibitor and an angiotensin receptor blocker was associated with an increased risk of hyperkalemia and acute kidney injury in patients with diabetic nephropathy in a randomized, controlled trial that was halted early because of these safety concerns.

"The risk-benefit ratio does not support the use of these medications – they’re not safe," noted Dr. Linda F. Fried, speaking at Kidney Week 2013.

The VA NEPHRON-D (Veterans Affairs Nephropathy in Diabetes) study involved 1,448 patients with type 2 diabetes and moderate diabetic nephropathy who were treated for at least 30 days with 100 mg daily of the angiotensin-receptor blocker (ARB) losartan, as is standard practice in patients with diabetes. The patients were randomized to also receive 10-40 mg daily of the angiotensin-converting enzyme (ACE) inhibitor lisinopril or placebo.

At a median follow-up of 2.2 years as of the time the study was stopped, 152 patients in the combination-therapy group and 132 in the placebo group (21% vs. 18.2%) experienced the composite primary endpoint of first occurrence of a predefined change in the estimated glomerular filtration rate (eGFR), end-stage renal disease (ESRD), or death (hazard ratio with combination therapy, 0.88). The difference between the groups was not statistically significant, said Dr. Fried, professor of medicine, epidemiology, and clinical and translational science at the University of Pittsburgh and chief of peritoneal dialysis at Veterans Affairs Pittsburgh Healthcare System.

Despite an early trend toward benefit, this trend diminished over time so that no significant difference was seen between the groups in the secondary renal end point of a first occurrence of a decline in the eGFR or ESRD (hazard ratio, 0.78). Also, no difference was seen between the groups with respect to the safety outcome of mortality (HR for death, 1.04). The rate of cardiovascular events in the groups was also similar.

However, there was a greater than twofold increase in the risk of hyperkalemia in the combination therapy group, compared with the placebo group (6.3 vs. 2.6 events/100 person-years), and a nearly twofold increase in the risk of acute kidney injury in the combination therapy group (12.2 vs. 6.7 event/100 person-years), Dr. Fried said at the conference, which was sponsored by the American Society of Nephrology.

The findings were published concurrently in the New England Journal of Medicine (2013 Nov. 9 [doi10.1056/NEJMoa1303154]).

Patients in the study had type 2 diabetes, a urinary albumin-to-creatinine ratio of at least 300, and an eGFR of 30.0 to 89.9 mL/minute per 1.73 m2 or body-surface area. Change in eGFR as specified for the composite primary endpoint of the study was a decline of at least 30 mL/minute per 1.73 m2 in those with an initial eGFR of at least 60 mL/minute per 1.73 m2, or a decline of at least 50% if the initial eGFR was less than 60 mL/minute per 1.73 m2.

Treatment with medications that block angiotensin are known to slow loss of kidney function in individuals with diabetes and proteinuria. This is true for both ACE inhibitors and ARBs, which have different mechanisms of action, but the percentage of patients who progress to dialysis despite treatment with one of these medications remains high, Dr. Fried said.

"So we need more treatments. A question that comes up is, ‘Would more intensive blockade of angiotensin – using two (drugs) together – slow decline?’ ... The thought was that treatments that lowered proteinuria should lower progression. We did see the lower proteinuria but without the benefit on the endpoints," she said during a press briefing in advance of the presentation of the late-breaking abstract.

Instead, it became clear that the treatment was associated with significantly more hyperkalemia and kidney injury, she said, noting that significantly more patients in the combination therapy group experienced acute kidney injury requiring hospitalization, indicating the problem was not just one of "lab abnormalities."

In fact, for every 100 persons followed for 1 year, there were 17 more admissions to the hospital, Dr. Fried said, noting that "these were not small differences in safety outcomes."

"The risk-benefit ratio does not support the use of these medications – they’re not safe." she concluded.

The VA-Nephron-D study was supported by the cooperative studies program of the Department of Veterans Affairs Office of Research and Development. The Investigator-Initiated Studies Program of Merck provided the study drugs. Dr. Fried reported receiving support from Reata Pharmaceuticals as a site investigator for a study. Other studies authors reported receiving lecture or consulting fees from Merck, Sanofi-Aventis, Complex, and/or CytoPherx.

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The VA Nephron-D study adds to existing evidence suggesting that dual renin-angiotensin-aldosterone system (RAAS) blockade does not decrease cardiovascular and renal morbidity, and actually carries increased risks, Dr. Dick de Zeeuw wrote in an editorial that accompanied the study by Fried, et al., in the New England Journal of Medicine.

"The effect of these ‘failed’ trials goes beyond the decision about whether we should use dual RAAS blockade in order to better protect our patients with diabetes. The results suggest that improvement in surrogate markers – lower blood pressure or less albuminuria – does not translate into risk reduction," he said (N. Engl. J. Med. 2013 Nov. 9 [doi:10.1056/NEJMe1312412]).

The findings make it clear that dual RAAS blockade for the treatment of patients with diabetes cannot currently be recommended, he said, adding that "we need to find ways to design trials that ultimately provide a better balance between efficacy and safety.

"An enrichment design, selecting patients with a defined albuminuria response without adverse events, is a first step and is currently being tested," he said.

While future studies will likely "measure and integrate multiple drug responses to predict the chance of obtaining positive hard outcomes," for now, dual RAAS blockade can only be resuscitated if it can be shown that renal and cardiovascular protection is possible in a defined group of patients in whom the desired effects (decreased blood pressure and/or albuminuria) can be achieved without increasing the risk of hyperkalemia and other side effects, he concluded.

Dr. de Zeeuw reported serving as an adviser or steering committee chair for AbbVie, Astellas, AstraZeneca, Bristol-Myers Squibb, ChemoCentryx, Johnson & Johnson, and Novartis, all of which have paid fees to his institution.

Dr. de Zeeuw is with the department of clinical pharmacology, University of Groningen, and University Medical Center Groningen, in the Netherlands.

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The VA Nephron-D study adds to existing evidence suggesting that dual renin-angiotensin-aldosterone system (RAAS) blockade does not decrease cardiovascular and renal morbidity, and actually carries increased risks, Dr. Dick de Zeeuw wrote in an editorial that accompanied the study by Fried, et al., in the New England Journal of Medicine.

"The effect of these ‘failed’ trials goes beyond the decision about whether we should use dual RAAS blockade in order to better protect our patients with diabetes. The results suggest that improvement in surrogate markers – lower blood pressure or less albuminuria – does not translate into risk reduction," he said (N. Engl. J. Med. 2013 Nov. 9 [doi:10.1056/NEJMe1312412]).

The findings make it clear that dual RAAS blockade for the treatment of patients with diabetes cannot currently be recommended, he said, adding that "we need to find ways to design trials that ultimately provide a better balance between efficacy and safety.

"An enrichment design, selecting patients with a defined albuminuria response without adverse events, is a first step and is currently being tested," he said.

While future studies will likely "measure and integrate multiple drug responses to predict the chance of obtaining positive hard outcomes," for now, dual RAAS blockade can only be resuscitated if it can be shown that renal and cardiovascular protection is possible in a defined group of patients in whom the desired effects (decreased blood pressure and/or albuminuria) can be achieved without increasing the risk of hyperkalemia and other side effects, he concluded.

Dr. de Zeeuw reported serving as an adviser or steering committee chair for AbbVie, Astellas, AstraZeneca, Bristol-Myers Squibb, ChemoCentryx, Johnson & Johnson, and Novartis, all of which have paid fees to his institution.

Dr. de Zeeuw is with the department of clinical pharmacology, University of Groningen, and University Medical Center Groningen, in the Netherlands.

Body

The VA Nephron-D study adds to existing evidence suggesting that dual renin-angiotensin-aldosterone system (RAAS) blockade does not decrease cardiovascular and renal morbidity, and actually carries increased risks, Dr. Dick de Zeeuw wrote in an editorial that accompanied the study by Fried, et al., in the New England Journal of Medicine.

"The effect of these ‘failed’ trials goes beyond the decision about whether we should use dual RAAS blockade in order to better protect our patients with diabetes. The results suggest that improvement in surrogate markers – lower blood pressure or less albuminuria – does not translate into risk reduction," he said (N. Engl. J. Med. 2013 Nov. 9 [doi:10.1056/NEJMe1312412]).

The findings make it clear that dual RAAS blockade for the treatment of patients with diabetes cannot currently be recommended, he said, adding that "we need to find ways to design trials that ultimately provide a better balance between efficacy and safety.

"An enrichment design, selecting patients with a defined albuminuria response without adverse events, is a first step and is currently being tested," he said.

While future studies will likely "measure and integrate multiple drug responses to predict the chance of obtaining positive hard outcomes," for now, dual RAAS blockade can only be resuscitated if it can be shown that renal and cardiovascular protection is possible in a defined group of patients in whom the desired effects (decreased blood pressure and/or albuminuria) can be achieved without increasing the risk of hyperkalemia and other side effects, he concluded.

Dr. de Zeeuw reported serving as an adviser or steering committee chair for AbbVie, Astellas, AstraZeneca, Bristol-Myers Squibb, ChemoCentryx, Johnson & Johnson, and Novartis, all of which have paid fees to his institution.

Dr. de Zeeuw is with the department of clinical pharmacology, University of Groningen, and University Medical Center Groningen, in the Netherlands.

Title
Finding marks end of dual RAAS blockade – for now
Finding marks end of dual RAAS blockade – for now

ATLANTA – The combined use of an angiotensin-converting enzyme inhibitor and an angiotensin receptor blocker was associated with an increased risk of hyperkalemia and acute kidney injury in patients with diabetic nephropathy in a randomized, controlled trial that was halted early because of these safety concerns.

"The risk-benefit ratio does not support the use of these medications – they’re not safe," noted Dr. Linda F. Fried, speaking at Kidney Week 2013.

The VA NEPHRON-D (Veterans Affairs Nephropathy in Diabetes) study involved 1,448 patients with type 2 diabetes and moderate diabetic nephropathy who were treated for at least 30 days with 100 mg daily of the angiotensin-receptor blocker (ARB) losartan, as is standard practice in patients with diabetes. The patients were randomized to also receive 10-40 mg daily of the angiotensin-converting enzyme (ACE) inhibitor lisinopril or placebo.

At a median follow-up of 2.2 years as of the time the study was stopped, 152 patients in the combination-therapy group and 132 in the placebo group (21% vs. 18.2%) experienced the composite primary endpoint of first occurrence of a predefined change in the estimated glomerular filtration rate (eGFR), end-stage renal disease (ESRD), or death (hazard ratio with combination therapy, 0.88). The difference between the groups was not statistically significant, said Dr. Fried, professor of medicine, epidemiology, and clinical and translational science at the University of Pittsburgh and chief of peritoneal dialysis at Veterans Affairs Pittsburgh Healthcare System.

Despite an early trend toward benefit, this trend diminished over time so that no significant difference was seen between the groups in the secondary renal end point of a first occurrence of a decline in the eGFR or ESRD (hazard ratio, 0.78). Also, no difference was seen between the groups with respect to the safety outcome of mortality (HR for death, 1.04). The rate of cardiovascular events in the groups was also similar.

However, there was a greater than twofold increase in the risk of hyperkalemia in the combination therapy group, compared with the placebo group (6.3 vs. 2.6 events/100 person-years), and a nearly twofold increase in the risk of acute kidney injury in the combination therapy group (12.2 vs. 6.7 event/100 person-years), Dr. Fried said at the conference, which was sponsored by the American Society of Nephrology.

The findings were published concurrently in the New England Journal of Medicine (2013 Nov. 9 [doi10.1056/NEJMoa1303154]).

Patients in the study had type 2 diabetes, a urinary albumin-to-creatinine ratio of at least 300, and an eGFR of 30.0 to 89.9 mL/minute per 1.73 m2 or body-surface area. Change in eGFR as specified for the composite primary endpoint of the study was a decline of at least 30 mL/minute per 1.73 m2 in those with an initial eGFR of at least 60 mL/minute per 1.73 m2, or a decline of at least 50% if the initial eGFR was less than 60 mL/minute per 1.73 m2.

Treatment with medications that block angiotensin are known to slow loss of kidney function in individuals with diabetes and proteinuria. This is true for both ACE inhibitors and ARBs, which have different mechanisms of action, but the percentage of patients who progress to dialysis despite treatment with one of these medications remains high, Dr. Fried said.

"So we need more treatments. A question that comes up is, ‘Would more intensive blockade of angiotensin – using two (drugs) together – slow decline?’ ... The thought was that treatments that lowered proteinuria should lower progression. We did see the lower proteinuria but without the benefit on the endpoints," she said during a press briefing in advance of the presentation of the late-breaking abstract.

Instead, it became clear that the treatment was associated with significantly more hyperkalemia and kidney injury, she said, noting that significantly more patients in the combination therapy group experienced acute kidney injury requiring hospitalization, indicating the problem was not just one of "lab abnormalities."

In fact, for every 100 persons followed for 1 year, there were 17 more admissions to the hospital, Dr. Fried said, noting that "these were not small differences in safety outcomes."

"The risk-benefit ratio does not support the use of these medications – they’re not safe." she concluded.

The VA-Nephron-D study was supported by the cooperative studies program of the Department of Veterans Affairs Office of Research and Development. The Investigator-Initiated Studies Program of Merck provided the study drugs. Dr. Fried reported receiving support from Reata Pharmaceuticals as a site investigator for a study. Other studies authors reported receiving lecture or consulting fees from Merck, Sanofi-Aventis, Complex, and/or CytoPherx.

ATLANTA – The combined use of an angiotensin-converting enzyme inhibitor and an angiotensin receptor blocker was associated with an increased risk of hyperkalemia and acute kidney injury in patients with diabetic nephropathy in a randomized, controlled trial that was halted early because of these safety concerns.

"The risk-benefit ratio does not support the use of these medications – they’re not safe," noted Dr. Linda F. Fried, speaking at Kidney Week 2013.

The VA NEPHRON-D (Veterans Affairs Nephropathy in Diabetes) study involved 1,448 patients with type 2 diabetes and moderate diabetic nephropathy who were treated for at least 30 days with 100 mg daily of the angiotensin-receptor blocker (ARB) losartan, as is standard practice in patients with diabetes. The patients were randomized to also receive 10-40 mg daily of the angiotensin-converting enzyme (ACE) inhibitor lisinopril or placebo.

At a median follow-up of 2.2 years as of the time the study was stopped, 152 patients in the combination-therapy group and 132 in the placebo group (21% vs. 18.2%) experienced the composite primary endpoint of first occurrence of a predefined change in the estimated glomerular filtration rate (eGFR), end-stage renal disease (ESRD), or death (hazard ratio with combination therapy, 0.88). The difference between the groups was not statistically significant, said Dr. Fried, professor of medicine, epidemiology, and clinical and translational science at the University of Pittsburgh and chief of peritoneal dialysis at Veterans Affairs Pittsburgh Healthcare System.

Despite an early trend toward benefit, this trend diminished over time so that no significant difference was seen between the groups in the secondary renal end point of a first occurrence of a decline in the eGFR or ESRD (hazard ratio, 0.78). Also, no difference was seen between the groups with respect to the safety outcome of mortality (HR for death, 1.04). The rate of cardiovascular events in the groups was also similar.

However, there was a greater than twofold increase in the risk of hyperkalemia in the combination therapy group, compared with the placebo group (6.3 vs. 2.6 events/100 person-years), and a nearly twofold increase in the risk of acute kidney injury in the combination therapy group (12.2 vs. 6.7 event/100 person-years), Dr. Fried said at the conference, which was sponsored by the American Society of Nephrology.

The findings were published concurrently in the New England Journal of Medicine (2013 Nov. 9 [doi10.1056/NEJMoa1303154]).

Patients in the study had type 2 diabetes, a urinary albumin-to-creatinine ratio of at least 300, and an eGFR of 30.0 to 89.9 mL/minute per 1.73 m2 or body-surface area. Change in eGFR as specified for the composite primary endpoint of the study was a decline of at least 30 mL/minute per 1.73 m2 in those with an initial eGFR of at least 60 mL/minute per 1.73 m2, or a decline of at least 50% if the initial eGFR was less than 60 mL/minute per 1.73 m2.

Treatment with medications that block angiotensin are known to slow loss of kidney function in individuals with diabetes and proteinuria. This is true for both ACE inhibitors and ARBs, which have different mechanisms of action, but the percentage of patients who progress to dialysis despite treatment with one of these medications remains high, Dr. Fried said.

"So we need more treatments. A question that comes up is, ‘Would more intensive blockade of angiotensin – using two (drugs) together – slow decline?’ ... The thought was that treatments that lowered proteinuria should lower progression. We did see the lower proteinuria but without the benefit on the endpoints," she said during a press briefing in advance of the presentation of the late-breaking abstract.

Instead, it became clear that the treatment was associated with significantly more hyperkalemia and kidney injury, she said, noting that significantly more patients in the combination therapy group experienced acute kidney injury requiring hospitalization, indicating the problem was not just one of "lab abnormalities."

In fact, for every 100 persons followed for 1 year, there were 17 more admissions to the hospital, Dr. Fried said, noting that "these were not small differences in safety outcomes."

"The risk-benefit ratio does not support the use of these medications – they’re not safe." she concluded.

The VA-Nephron-D study was supported by the cooperative studies program of the Department of Veterans Affairs Office of Research and Development. The Investigator-Initiated Studies Program of Merck provided the study drugs. Dr. Fried reported receiving support from Reata Pharmaceuticals as a site investigator for a study. Other studies authors reported receiving lecture or consulting fees from Merck, Sanofi-Aventis, Complex, and/or CytoPherx.

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Combined angiotensin inhibition raises hyperkalemia, acute kidney injury risks

Finding marks end of dual RAAS blockade – for now
Article Type
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Combined angiotensin inhibition raises hyperkalemia, acute kidney injury risks

ATLANTA – The combined use of an angiotensin-converting enzyme inhibitor and an angiotensin receptor blocker was associated with an increased risk of hyperkalemia and acute kidney injury in patients with diabetic nephropathy in a randomized, controlled trial that was halted early because of these safety concerns.

"The risk-benefit ratio does not support the use of these medications – they’re not safe," noted Dr. Linda F. Fried, speaking at Kidney Week 2013.

The VA NEPHRON-D (Veterans Affairs Nephropathy in Diabetes) study involved 1,448 patients with type 2 diabetes and moderate diabetic nephropathy who were treated for at least 30 days with 100 mg daily of the angiotensin-receptor blocker (ARB) losartan, as is standard practice in patients with diabetes. The patients were randomized to also receive 10-40 mg daily of the angiotensin-converting enzyme (ACE) inhibitor lisinopril or placebo.

At a median follow-up of 2.2 years as of the time the study was stopped, 152 patients in the combination-therapy group and 132 in the placebo group (21% vs. 18.2%) experienced the composite primary endpoint of first occurrence of a predefined change in the estimated glomerular filtration rate (eGFR), end-stage renal disease (ESRD), or death (hazard ratio with combination therapy, 0.88). The difference between the groups was not statistically significant, said Dr. Fried, professor of medicine, epidemiology, and clinical and translational science at the University of Pittsburgh and chief of peritoneal dialysis at Veterans Affairs Pittsburgh Healthcare System.

Despite an early trend toward benefit, this trend diminished over time so that no significant difference was seen between the groups in the secondary renal end point of a first occurrence of a decline in the eGFR or ESRD (hazard ratio, 0.78). Also, no difference was seen between the groups with respect to the safety outcome of mortality (HR for death, 1.04). The rate of cardiovascular events in the groups was also similar.

However, there was a greater than twofold increase in the risk of hyperkalemia in the combination therapy group, compared with the placebo group (6.3 vs. 2.6 events/100 person-years), and a nearly twofold increase in the risk of acute kidney injury in the combination therapy group (12.2 vs. 6.7 event/100 person-years), Dr. Fried said at the conference, which was sponsored by the American Society of Nephrology.

The findings were published concurrently in the New England Journal of Medicine (2013 Nov. 9 [doi10.1056/NEJMoa1303154]).

Patients in the study had type 2 diabetes, a urinary albumin-to-creatinine ratio of at least 300, and an eGFR of 30.0 to 89.9 mL/minute per 1.73 m2 or body-surface area. Change in eGFR as specified for the composite primary endpoint of the study was a decline of at least 30 mL/minute per 1.73 m2 in those with an initial eGFR of at least 60 mL/minute per 1.73 m2, or a decline of at least 50% if the initial eGFR was less than 60 mL/minute per 1.73 m2.

Treatment with medications that block angiotensin are known to slow loss of kidney function in individuals with diabetes and proteinuria. This is true for both ACE inhibitors and ARBs, which have different mechanisms of action, but the percentage of patients who progress to dialysis despite treatment with one of these medications remains high, Dr. Fried said.

"So we need more treatments. A question that comes up is, ‘Would more intensive blockade of angiotensin – using two (drugs) together – slow decline?’ ... The thought was that treatments that lowered proteinuria should lower progression. We did see the lower proteinuria but without the benefit on the endpoints," she said during a press briefing in advance of the presentation of the late-breaking abstract.

Instead, it became clear that the treatment was associated with significantly more hyperkalemia and kidney injury, she said, noting that significantly more patients in the combination therapy group experienced acute kidney injury requiring hospitalization, indicating the problem was not just one of "lab abnormalities."

In fact, for every 100 persons followed for 1 year, there were 17 more admissions to the hospital, Dr. Fried said, noting that "these were not small differences in safety outcomes."

"The risk-benefit ratio does not support the use of these medications – they’re not safe." she concluded.

The VA-Nephron-D study was supported by the cooperative studies program of the Department of Veterans Affairs Office of Research and Development. The Investigator-Initiated Studies Program of Merck provided the study drugs. Dr. Fried reported receiving support from Reata Pharmaceuticals as a site investigator for a study. Other studies authors reported receiving lecture or consulting fees from Merck, Sanofi-Aventis, Complex, and/or CytoPherx.

Body

The VA Nephron-D study adds to existing evidence suggesting that dual renin-angiotensin-aldosterone system (RAAS) blockade does not decrease cardiovascular and renal morbidity, and actually carries increased risks, Dr. Dick de Zeeuw wrote in an editorial that accompanied the study by Fried, et al., in the New England Journal of Medicine.

"The effect of these ‘failed’ trials goes beyond the decision about whether we should use dual RAAS blockade in order to better protect our patients with diabetes. The results suggest that improvement in surrogate markers – lower blood pressure or less albuminuria – does not translate into risk reduction," he said (N. Engl. J. Med. 2013 Nov. 9 [doi:10.1056/NEJMe1312412]).

The findings make it clear that dual RAAS blockade for the treatment of patients with diabetes cannot currently be recommended, he said, adding that "we need to find ways to design trials that ultimately provide a better balance between efficacy and safety.

"An enrichment design, selecting patients with a defined albuminuria response without adverse events, is a first step and is currently being tested," he said.

While future studies will likely "measure and integrate multiple drug responses to predict the chance of obtaining positive hard outcomes," for now, dual RAAS blockade can only be resuscitated if it can be shown that renal and cardiovascular protection is possible in a defined group of patients in whom the desired effects (decreased blood pressure and/or albuminuria) can be achieved without increasing the risk of hyperkalemia and other side effects, he concluded.

Dr. de Zeeuw reported serving as an adviser or steering committee chair for AbbVie, Astellas, AstraZeneca, Bristol-Myers Squibb, ChemoCentryx, Johnson & Johnson, and Novartis, all of which have paid fees to his institution.

Dr. de Zeeuw is with the department of clinical pharmacology, University of Groningen, and University Medical Center Groningen, in the Netherlands.

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The VA Nephron-D study adds to existing evidence suggesting that dual renin-angiotensin-aldosterone system (RAAS) blockade does not decrease cardiovascular and renal morbidity, and actually carries increased risks, Dr. Dick de Zeeuw wrote in an editorial that accompanied the study by Fried, et al., in the New England Journal of Medicine.

"The effect of these ‘failed’ trials goes beyond the decision about whether we should use dual RAAS blockade in order to better protect our patients with diabetes. The results suggest that improvement in surrogate markers – lower blood pressure or less albuminuria – does not translate into risk reduction," he said (N. Engl. J. Med. 2013 Nov. 9 [doi:10.1056/NEJMe1312412]).

The findings make it clear that dual RAAS blockade for the treatment of patients with diabetes cannot currently be recommended, he said, adding that "we need to find ways to design trials that ultimately provide a better balance between efficacy and safety.

"An enrichment design, selecting patients with a defined albuminuria response without adverse events, is a first step and is currently being tested," he said.

While future studies will likely "measure and integrate multiple drug responses to predict the chance of obtaining positive hard outcomes," for now, dual RAAS blockade can only be resuscitated if it can be shown that renal and cardiovascular protection is possible in a defined group of patients in whom the desired effects (decreased blood pressure and/or albuminuria) can be achieved without increasing the risk of hyperkalemia and other side effects, he concluded.

Dr. de Zeeuw reported serving as an adviser or steering committee chair for AbbVie, Astellas, AstraZeneca, Bristol-Myers Squibb, ChemoCentryx, Johnson & Johnson, and Novartis, all of which have paid fees to his institution.

Dr. de Zeeuw is with the department of clinical pharmacology, University of Groningen, and University Medical Center Groningen, in the Netherlands.

Body

The VA Nephron-D study adds to existing evidence suggesting that dual renin-angiotensin-aldosterone system (RAAS) blockade does not decrease cardiovascular and renal morbidity, and actually carries increased risks, Dr. Dick de Zeeuw wrote in an editorial that accompanied the study by Fried, et al., in the New England Journal of Medicine.

"The effect of these ‘failed’ trials goes beyond the decision about whether we should use dual RAAS blockade in order to better protect our patients with diabetes. The results suggest that improvement in surrogate markers – lower blood pressure or less albuminuria – does not translate into risk reduction," he said (N. Engl. J. Med. 2013 Nov. 9 [doi:10.1056/NEJMe1312412]).

The findings make it clear that dual RAAS blockade for the treatment of patients with diabetes cannot currently be recommended, he said, adding that "we need to find ways to design trials that ultimately provide a better balance between efficacy and safety.

"An enrichment design, selecting patients with a defined albuminuria response without adverse events, is a first step and is currently being tested," he said.

While future studies will likely "measure and integrate multiple drug responses to predict the chance of obtaining positive hard outcomes," for now, dual RAAS blockade can only be resuscitated if it can be shown that renal and cardiovascular protection is possible in a defined group of patients in whom the desired effects (decreased blood pressure and/or albuminuria) can be achieved without increasing the risk of hyperkalemia and other side effects, he concluded.

Dr. de Zeeuw reported serving as an adviser or steering committee chair for AbbVie, Astellas, AstraZeneca, Bristol-Myers Squibb, ChemoCentryx, Johnson & Johnson, and Novartis, all of which have paid fees to his institution.

Dr. de Zeeuw is with the department of clinical pharmacology, University of Groningen, and University Medical Center Groningen, in the Netherlands.

Title
Finding marks end of dual RAAS blockade – for now
Finding marks end of dual RAAS blockade – for now

ATLANTA – The combined use of an angiotensin-converting enzyme inhibitor and an angiotensin receptor blocker was associated with an increased risk of hyperkalemia and acute kidney injury in patients with diabetic nephropathy in a randomized, controlled trial that was halted early because of these safety concerns.

"The risk-benefit ratio does not support the use of these medications – they’re not safe," noted Dr. Linda F. Fried, speaking at Kidney Week 2013.

The VA NEPHRON-D (Veterans Affairs Nephropathy in Diabetes) study involved 1,448 patients with type 2 diabetes and moderate diabetic nephropathy who were treated for at least 30 days with 100 mg daily of the angiotensin-receptor blocker (ARB) losartan, as is standard practice in patients with diabetes. The patients were randomized to also receive 10-40 mg daily of the angiotensin-converting enzyme (ACE) inhibitor lisinopril or placebo.

At a median follow-up of 2.2 years as of the time the study was stopped, 152 patients in the combination-therapy group and 132 in the placebo group (21% vs. 18.2%) experienced the composite primary endpoint of first occurrence of a predefined change in the estimated glomerular filtration rate (eGFR), end-stage renal disease (ESRD), or death (hazard ratio with combination therapy, 0.88). The difference between the groups was not statistically significant, said Dr. Fried, professor of medicine, epidemiology, and clinical and translational science at the University of Pittsburgh and chief of peritoneal dialysis at Veterans Affairs Pittsburgh Healthcare System.

Despite an early trend toward benefit, this trend diminished over time so that no significant difference was seen between the groups in the secondary renal end point of a first occurrence of a decline in the eGFR or ESRD (hazard ratio, 0.78). Also, no difference was seen between the groups with respect to the safety outcome of mortality (HR for death, 1.04). The rate of cardiovascular events in the groups was also similar.

However, there was a greater than twofold increase in the risk of hyperkalemia in the combination therapy group, compared with the placebo group (6.3 vs. 2.6 events/100 person-years), and a nearly twofold increase in the risk of acute kidney injury in the combination therapy group (12.2 vs. 6.7 event/100 person-years), Dr. Fried said at the conference, which was sponsored by the American Society of Nephrology.

The findings were published concurrently in the New England Journal of Medicine (2013 Nov. 9 [doi10.1056/NEJMoa1303154]).

Patients in the study had type 2 diabetes, a urinary albumin-to-creatinine ratio of at least 300, and an eGFR of 30.0 to 89.9 mL/minute per 1.73 m2 or body-surface area. Change in eGFR as specified for the composite primary endpoint of the study was a decline of at least 30 mL/minute per 1.73 m2 in those with an initial eGFR of at least 60 mL/minute per 1.73 m2, or a decline of at least 50% if the initial eGFR was less than 60 mL/minute per 1.73 m2.

Treatment with medications that block angiotensin are known to slow loss of kidney function in individuals with diabetes and proteinuria. This is true for both ACE inhibitors and ARBs, which have different mechanisms of action, but the percentage of patients who progress to dialysis despite treatment with one of these medications remains high, Dr. Fried said.

"So we need more treatments. A question that comes up is, ‘Would more intensive blockade of angiotensin – using two (drugs) together – slow decline?’ ... The thought was that treatments that lowered proteinuria should lower progression. We did see the lower proteinuria but without the benefit on the endpoints," she said during a press briefing in advance of the presentation of the late-breaking abstract.

Instead, it became clear that the treatment was associated with significantly more hyperkalemia and kidney injury, she said, noting that significantly more patients in the combination therapy group experienced acute kidney injury requiring hospitalization, indicating the problem was not just one of "lab abnormalities."

In fact, for every 100 persons followed for 1 year, there were 17 more admissions to the hospital, Dr. Fried said, noting that "these were not small differences in safety outcomes."

"The risk-benefit ratio does not support the use of these medications – they’re not safe." she concluded.

The VA-Nephron-D study was supported by the cooperative studies program of the Department of Veterans Affairs Office of Research and Development. The Investigator-Initiated Studies Program of Merck provided the study drugs. Dr. Fried reported receiving support from Reata Pharmaceuticals as a site investigator for a study. Other studies authors reported receiving lecture or consulting fees from Merck, Sanofi-Aventis, Complex, and/or CytoPherx.

ATLANTA – The combined use of an angiotensin-converting enzyme inhibitor and an angiotensin receptor blocker was associated with an increased risk of hyperkalemia and acute kidney injury in patients with diabetic nephropathy in a randomized, controlled trial that was halted early because of these safety concerns.

"The risk-benefit ratio does not support the use of these medications – they’re not safe," noted Dr. Linda F. Fried, speaking at Kidney Week 2013.

The VA NEPHRON-D (Veterans Affairs Nephropathy in Diabetes) study involved 1,448 patients with type 2 diabetes and moderate diabetic nephropathy who were treated for at least 30 days with 100 mg daily of the angiotensin-receptor blocker (ARB) losartan, as is standard practice in patients with diabetes. The patients were randomized to also receive 10-40 mg daily of the angiotensin-converting enzyme (ACE) inhibitor lisinopril or placebo.

At a median follow-up of 2.2 years as of the time the study was stopped, 152 patients in the combination-therapy group and 132 in the placebo group (21% vs. 18.2%) experienced the composite primary endpoint of first occurrence of a predefined change in the estimated glomerular filtration rate (eGFR), end-stage renal disease (ESRD), or death (hazard ratio with combination therapy, 0.88). The difference between the groups was not statistically significant, said Dr. Fried, professor of medicine, epidemiology, and clinical and translational science at the University of Pittsburgh and chief of peritoneal dialysis at Veterans Affairs Pittsburgh Healthcare System.

Despite an early trend toward benefit, this trend diminished over time so that no significant difference was seen between the groups in the secondary renal end point of a first occurrence of a decline in the eGFR or ESRD (hazard ratio, 0.78). Also, no difference was seen between the groups with respect to the safety outcome of mortality (HR for death, 1.04). The rate of cardiovascular events in the groups was also similar.

However, there was a greater than twofold increase in the risk of hyperkalemia in the combination therapy group, compared with the placebo group (6.3 vs. 2.6 events/100 person-years), and a nearly twofold increase in the risk of acute kidney injury in the combination therapy group (12.2 vs. 6.7 event/100 person-years), Dr. Fried said at the conference, which was sponsored by the American Society of Nephrology.

The findings were published concurrently in the New England Journal of Medicine (2013 Nov. 9 [doi10.1056/NEJMoa1303154]).

Patients in the study had type 2 diabetes, a urinary albumin-to-creatinine ratio of at least 300, and an eGFR of 30.0 to 89.9 mL/minute per 1.73 m2 or body-surface area. Change in eGFR as specified for the composite primary endpoint of the study was a decline of at least 30 mL/minute per 1.73 m2 in those with an initial eGFR of at least 60 mL/minute per 1.73 m2, or a decline of at least 50% if the initial eGFR was less than 60 mL/minute per 1.73 m2.

Treatment with medications that block angiotensin are known to slow loss of kidney function in individuals with diabetes and proteinuria. This is true for both ACE inhibitors and ARBs, which have different mechanisms of action, but the percentage of patients who progress to dialysis despite treatment with one of these medications remains high, Dr. Fried said.

"So we need more treatments. A question that comes up is, ‘Would more intensive blockade of angiotensin – using two (drugs) together – slow decline?’ ... The thought was that treatments that lowered proteinuria should lower progression. We did see the lower proteinuria but without the benefit on the endpoints," she said during a press briefing in advance of the presentation of the late-breaking abstract.

Instead, it became clear that the treatment was associated with significantly more hyperkalemia and kidney injury, she said, noting that significantly more patients in the combination therapy group experienced acute kidney injury requiring hospitalization, indicating the problem was not just one of "lab abnormalities."

In fact, for every 100 persons followed for 1 year, there were 17 more admissions to the hospital, Dr. Fried said, noting that "these were not small differences in safety outcomes."

"The risk-benefit ratio does not support the use of these medications – they’re not safe." she concluded.

The VA-Nephron-D study was supported by the cooperative studies program of the Department of Veterans Affairs Office of Research and Development. The Investigator-Initiated Studies Program of Merck provided the study drugs. Dr. Fried reported receiving support from Reata Pharmaceuticals as a site investigator for a study. Other studies authors reported receiving lecture or consulting fees from Merck, Sanofi-Aventis, Complex, and/or CytoPherx.

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Major finding: There was an increased risk of hyperkalemia (6.3 vs. 2.6 events/100 person-years) and acute kidney injury (12.2 vs. 6.7 events/100 person-years) with combination ACE inhibitor/ARB therapy vs. monotherapy with losartan.

Data source: A multicenter, double-blind, randomized, controlled study of 1,448 patients

Disclosures: The VA-Nephron-D study was supported by the cooperative studies program of the Department of Veterans Affairs Office of Research and Development. The Investigator-Initiated Studies Program of Merck provided the study drugs. Dr. Fried reported receiving support from Reata Pharmaceuticals as a site investigator for a study. Other studies authors reported receiving lecture or consulting fees from Merck, Sanofi-Aventis, Complex, and/or CytoPherx.

Remote Otitis Media Diagnosis

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ORLANDO – A novel smartphone otoscope attachment provides clear, transmittable images of the ear drum or tympanic membrane, and could revolutionize the approach to diagnosing and managing ear infections, according to Dr. Kathryn Rappaport.

In a prospective study involving 63 children who presented to an emergency department between May and December 2012 with upper respiratory tract symptoms, the technology was as effective as a conventional otoscope, and was widely accepted by parents, Dr. Rappaport of Baylor College of Medicine, Houston, reported at the annual meeting of the American Academy of Pediatrics.

Courtesy CellScope
A novel smartphone otoscope attachment provides clear, transmittable images of the ear drum or tympanic membrane, and could revolutionize the approach to diagnosing and managing ear infections, according to Dr. Kathryn Rappaport.

After receiving clinical care, each child in the study underwent bilateral otic videoscopy using both the smartphone otoscope (CellScope Oto) and a camera-fitted conventional otoscope. The procedures were performed in random order, said Dr. Rappaport, who was at Emory University in Atlanta when the study was conducted.

Of the children, who had a mean age of 2.9 years, 49 received a clinical diagnosis of acute otitis media by an ED practitioner. Based on independent scoring by four physicians who evaluated 31 CellScope Oto videos and 31 conventional otoscope videos from 26 subjects, there was no difference between the two technologies in either the diagnostic quality of the images or diagnosis confidence ratings.

Diagnosis and treatment decision making were similar with each device. Overall, the physician raters were in fair agreement regarding the clinical ED diagnosis of acute otitis media, while two of the raters had moderate to substantial agreement with the ED diagnosis and two had poor agreement with the ED diagnosis from images obtained via conventional otoscope, Dr. Rappaport said, noting that there was a significant correlation between antimicrobial use and image quality.

This indicated that higher-quality images were more likely to be associated with a definitive diagnosis, she said.

As for parent reactions to the use of the device, most (95%) responded favorably, stating that the CellScope Oto images improved their understanding of their child’s management. Also, 90% said they thought the technology would be easy to use, and they would feel comfortable using it remotely to transmit images to a provider.

The CellScope Oto has the potential to improve diagnosis and management, and to reduce costs associated with acute otitis media in children, Dr. Rappaport said.

The video images can provide a baseline, as well as ongoing documentation of a child’s condition. The video documentation could allow a child to be followed over a period of time – without the need for regular office visits – to help monitor for progression or resolution of middle ear effusion and to guide diagnosis and treatment decision making, she explained.

"Acute otitis media is the most common reason for antimicrobial prescriptions in children. In the future, we would like to study whether the ability to monitor for resolution of a patient’s middle ear effusion using digital imaging with the smartphone otoscope will lead to decreased antimicrobial prescriptions for acute otitis media in children," she said in an interview.

Dr. Rappaport reported having no relevant financial disclosures.

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ORLANDO – A novel smartphone otoscope attachment provides clear, transmittable images of the ear drum or tympanic membrane, and could revolutionize the approach to diagnosing and managing ear infections, according to Dr. Kathryn Rappaport.

In a prospective study involving 63 children who presented to an emergency department between May and December 2012 with upper respiratory tract symptoms, the technology was as effective as a conventional otoscope, and was widely accepted by parents, Dr. Rappaport of Baylor College of Medicine, Houston, reported at the annual meeting of the American Academy of Pediatrics.

Courtesy CellScope
A novel smartphone otoscope attachment provides clear, transmittable images of the ear drum or tympanic membrane, and could revolutionize the approach to diagnosing and managing ear infections, according to Dr. Kathryn Rappaport.

After receiving clinical care, each child in the study underwent bilateral otic videoscopy using both the smartphone otoscope (CellScope Oto) and a camera-fitted conventional otoscope. The procedures were performed in random order, said Dr. Rappaport, who was at Emory University in Atlanta when the study was conducted.

Of the children, who had a mean age of 2.9 years, 49 received a clinical diagnosis of acute otitis media by an ED practitioner. Based on independent scoring by four physicians who evaluated 31 CellScope Oto videos and 31 conventional otoscope videos from 26 subjects, there was no difference between the two technologies in either the diagnostic quality of the images or diagnosis confidence ratings.

Diagnosis and treatment decision making were similar with each device. Overall, the physician raters were in fair agreement regarding the clinical ED diagnosis of acute otitis media, while two of the raters had moderate to substantial agreement with the ED diagnosis and two had poor agreement with the ED diagnosis from images obtained via conventional otoscope, Dr. Rappaport said, noting that there was a significant correlation between antimicrobial use and image quality.

This indicated that higher-quality images were more likely to be associated with a definitive diagnosis, she said.

As for parent reactions to the use of the device, most (95%) responded favorably, stating that the CellScope Oto images improved their understanding of their child’s management. Also, 90% said they thought the technology would be easy to use, and they would feel comfortable using it remotely to transmit images to a provider.

The CellScope Oto has the potential to improve diagnosis and management, and to reduce costs associated with acute otitis media in children, Dr. Rappaport said.

The video images can provide a baseline, as well as ongoing documentation of a child’s condition. The video documentation could allow a child to be followed over a period of time – without the need for regular office visits – to help monitor for progression or resolution of middle ear effusion and to guide diagnosis and treatment decision making, she explained.

"Acute otitis media is the most common reason for antimicrobial prescriptions in children. In the future, we would like to study whether the ability to monitor for resolution of a patient’s middle ear effusion using digital imaging with the smartphone otoscope will lead to decreased antimicrobial prescriptions for acute otitis media in children," she said in an interview.

Dr. Rappaport reported having no relevant financial disclosures.

ORLANDO – A novel smartphone otoscope attachment provides clear, transmittable images of the ear drum or tympanic membrane, and could revolutionize the approach to diagnosing and managing ear infections, according to Dr. Kathryn Rappaport.

In a prospective study involving 63 children who presented to an emergency department between May and December 2012 with upper respiratory tract symptoms, the technology was as effective as a conventional otoscope, and was widely accepted by parents, Dr. Rappaport of Baylor College of Medicine, Houston, reported at the annual meeting of the American Academy of Pediatrics.

Courtesy CellScope
A novel smartphone otoscope attachment provides clear, transmittable images of the ear drum or tympanic membrane, and could revolutionize the approach to diagnosing and managing ear infections, according to Dr. Kathryn Rappaport.

After receiving clinical care, each child in the study underwent bilateral otic videoscopy using both the smartphone otoscope (CellScope Oto) and a camera-fitted conventional otoscope. The procedures were performed in random order, said Dr. Rappaport, who was at Emory University in Atlanta when the study was conducted.

Of the children, who had a mean age of 2.9 years, 49 received a clinical diagnosis of acute otitis media by an ED practitioner. Based on independent scoring by four physicians who evaluated 31 CellScope Oto videos and 31 conventional otoscope videos from 26 subjects, there was no difference between the two technologies in either the diagnostic quality of the images or diagnosis confidence ratings.

Diagnosis and treatment decision making were similar with each device. Overall, the physician raters were in fair agreement regarding the clinical ED diagnosis of acute otitis media, while two of the raters had moderate to substantial agreement with the ED diagnosis and two had poor agreement with the ED diagnosis from images obtained via conventional otoscope, Dr. Rappaport said, noting that there was a significant correlation between antimicrobial use and image quality.

This indicated that higher-quality images were more likely to be associated with a definitive diagnosis, she said.

As for parent reactions to the use of the device, most (95%) responded favorably, stating that the CellScope Oto images improved their understanding of their child’s management. Also, 90% said they thought the technology would be easy to use, and they would feel comfortable using it remotely to transmit images to a provider.

The CellScope Oto has the potential to improve diagnosis and management, and to reduce costs associated with acute otitis media in children, Dr. Rappaport said.

The video images can provide a baseline, as well as ongoing documentation of a child’s condition. The video documentation could allow a child to be followed over a period of time – without the need for regular office visits – to help monitor for progression or resolution of middle ear effusion and to guide diagnosis and treatment decision making, she explained.

"Acute otitis media is the most common reason for antimicrobial prescriptions in children. In the future, we would like to study whether the ability to monitor for resolution of a patient’s middle ear effusion using digital imaging with the smartphone otoscope will lead to decreased antimicrobial prescriptions for acute otitis media in children," she said in an interview.

Dr. Rappaport reported having no relevant financial disclosures.

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ORLANDO – A novel smartphone otoscope attachment provides clear, transmittable images of the ear drum or tympanic membrane, and could revolutionize the approach to diagnosing and managing ear infections, according to Dr. Kathryn Rappaport.

In a prospective study involving 63 children who presented to an emergency department between May and December 2012 with upper respiratory tract symptoms, the technology was as effective as a conventional otoscope, and was widely accepted by parents, Dr. Rappaport of Baylor College of Medicine, Houston, reported at the annual meeting of the American Academy of Pediatrics.

Courtesy CellScope
A novel smartphone otoscope attachment provides clear, transmittable images of the ear drum or tympanic membrane, and could revolutionize the approach to diagnosing and managing ear infections, according to Dr. Kathryn Rappaport.

After receiving clinical care, each child in the study underwent bilateral otic videoscopy using both the smartphone otoscope (CellScope Oto) and a camera-fitted conventional otoscope. The procedures were performed in random order, said Dr. Rappaport, who was at Emory University in Atlanta when the study was conducted.

Of the children, who had a mean age of 2.9 years, 49 received a clinical diagnosis of acute otitis media by an ED practitioner. Based on independent scoring by four physicians who evaluated 31 CellScope Oto videos and 31 conventional otoscope videos from 26 subjects, there was no difference between the two technologies in either the diagnostic quality of the images or diagnosis confidence ratings.

Diagnosis and treatment decision making were similar with each device. Overall, the physician raters were in fair agreement regarding the clinical ED diagnosis of acute otitis media, while two of the raters had moderate to substantial agreement with the ED diagnosis and two had poor agreement with the ED diagnosis from images obtained via conventional otoscope, Dr. Rappaport said, noting that there was a significant correlation between antimicrobial use and image quality.

This indicated that higher-quality images were more likely to be associated with a definitive diagnosis, she said.

As for parent reactions to the use of the device, most (95%) responded favorably, stating that the CellScope Oto images improved their understanding of their child’s management. Also, 90% said they thought the technology would be easy to use, and they would feel comfortable using it remotely to transmit images to a provider.

The CellScope Oto has the potential to improve diagnosis and management, and to reduce costs associated with acute otitis media in children, Dr. Rappaport said.

The video images can provide a baseline, as well as ongoing documentation of a child’s condition. The video documentation could allow a child to be followed over a period of time – without the need for regular office visits – to help monitor for progression or resolution of middle ear effusion and to guide diagnosis and treatment decision making, she explained.

"Acute otitis media is the most common reason for antimicrobial prescriptions in children. In the future, we would like to study whether the ability to monitor for resolution of a patient’s middle ear effusion using digital imaging with the smartphone otoscope will lead to decreased antimicrobial prescriptions for acute otitis media in children," she said in an interview.

Dr. Rappaport reported having no relevant financial disclosures.

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ORLANDO – A novel smartphone otoscope attachment provides clear, transmittable images of the ear drum or tympanic membrane, and could revolutionize the approach to diagnosing and managing ear infections, according to Dr. Kathryn Rappaport.

In a prospective study involving 63 children who presented to an emergency department between May and December 2012 with upper respiratory tract symptoms, the technology was as effective as a conventional otoscope, and was widely accepted by parents, Dr. Rappaport of Baylor College of Medicine, Houston, reported at the annual meeting of the American Academy of Pediatrics.

Courtesy CellScope
A novel smartphone otoscope attachment provides clear, transmittable images of the ear drum or tympanic membrane, and could revolutionize the approach to diagnosing and managing ear infections, according to Dr. Kathryn Rappaport.

After receiving clinical care, each child in the study underwent bilateral otic videoscopy using both the smartphone otoscope (CellScope Oto) and a camera-fitted conventional otoscope. The procedures were performed in random order, said Dr. Rappaport, who was at Emory University in Atlanta when the study was conducted.

Of the children, who had a mean age of 2.9 years, 49 received a clinical diagnosis of acute otitis media by an ED practitioner. Based on independent scoring by four physicians who evaluated 31 CellScope Oto videos and 31 conventional otoscope videos from 26 subjects, there was no difference between the two technologies in either the diagnostic quality of the images or diagnosis confidence ratings.

Diagnosis and treatment decision making were similar with each device. Overall, the physician raters were in fair agreement regarding the clinical ED diagnosis of acute otitis media, while two of the raters had moderate to substantial agreement with the ED diagnosis and two had poor agreement with the ED diagnosis from images obtained via conventional otoscope, Dr. Rappaport said, noting that there was a significant correlation between antimicrobial use and image quality.

This indicated that higher-quality images were more likely to be associated with a definitive diagnosis, she said.

As for parent reactions to the use of the device, most (95%) responded favorably, stating that the CellScope Oto images improved their understanding of their child’s management. Also, 90% said they thought the technology would be easy to use, and they would feel comfortable using it remotely to transmit images to a provider.

The CellScope Oto has the potential to improve diagnosis and management, and to reduce costs associated with acute otitis media in children, Dr. Rappaport said.

The video images can provide a baseline, as well as ongoing documentation of a child’s condition. The video documentation could allow a child to be followed over a period of time – without the need for regular office visits – to help monitor for progression or resolution of middle ear effusion and to guide diagnosis and treatment decision making, she explained.

"Acute otitis media is the most common reason for antimicrobial prescriptions in children. In the future, we would like to study whether the ability to monitor for resolution of a patient’s middle ear effusion using digital imaging with the smartphone otoscope will lead to decreased antimicrobial prescriptions for acute otitis media in children," she said in an interview.

Dr. Rappaport reported having no relevant financial disclosures.

ORLANDO – A novel smartphone otoscope attachment provides clear, transmittable images of the ear drum or tympanic membrane, and could revolutionize the approach to diagnosing and managing ear infections, according to Dr. Kathryn Rappaport.

In a prospective study involving 63 children who presented to an emergency department between May and December 2012 with upper respiratory tract symptoms, the technology was as effective as a conventional otoscope, and was widely accepted by parents, Dr. Rappaport of Baylor College of Medicine, Houston, reported at the annual meeting of the American Academy of Pediatrics.

Courtesy CellScope
A novel smartphone otoscope attachment provides clear, transmittable images of the ear drum or tympanic membrane, and could revolutionize the approach to diagnosing and managing ear infections, according to Dr. Kathryn Rappaport.

After receiving clinical care, each child in the study underwent bilateral otic videoscopy using both the smartphone otoscope (CellScope Oto) and a camera-fitted conventional otoscope. The procedures were performed in random order, said Dr. Rappaport, who was at Emory University in Atlanta when the study was conducted.

Of the children, who had a mean age of 2.9 years, 49 received a clinical diagnosis of acute otitis media by an ED practitioner. Based on independent scoring by four physicians who evaluated 31 CellScope Oto videos and 31 conventional otoscope videos from 26 subjects, there was no difference between the two technologies in either the diagnostic quality of the images or diagnosis confidence ratings.

Diagnosis and treatment decision making were similar with each device. Overall, the physician raters were in fair agreement regarding the clinical ED diagnosis of acute otitis media, while two of the raters had moderate to substantial agreement with the ED diagnosis and two had poor agreement with the ED diagnosis from images obtained via conventional otoscope, Dr. Rappaport said, noting that there was a significant correlation between antimicrobial use and image quality.

This indicated that higher-quality images were more likely to be associated with a definitive diagnosis, she said.

As for parent reactions to the use of the device, most (95%) responded favorably, stating that the CellScope Oto images improved their understanding of their child’s management. Also, 90% said they thought the technology would be easy to use, and they would feel comfortable using it remotely to transmit images to a provider.

The CellScope Oto has the potential to improve diagnosis and management, and to reduce costs associated with acute otitis media in children, Dr. Rappaport said.

The video images can provide a baseline, as well as ongoing documentation of a child’s condition. The video documentation could allow a child to be followed over a period of time – without the need for regular office visits – to help monitor for progression or resolution of middle ear effusion and to guide diagnosis and treatment decision making, she explained.

"Acute otitis media is the most common reason for antimicrobial prescriptions in children. In the future, we would like to study whether the ability to monitor for resolution of a patient’s middle ear effusion using digital imaging with the smartphone otoscope will lead to decreased antimicrobial prescriptions for acute otitis media in children," she said in an interview.

Dr. Rappaport reported having no relevant financial disclosures.

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Major finding: No difference was seen between the smartphone otoscope and a conventional otoscope in either the diagnostic quality of the images or diagnosis confidence ratings.

Data source: A prospective single-site study of 63 children.

Disclosures: Dr. Rappaport reported having no relevant financial disclosures.

Mediterranean diet may lower CKD risk

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ATLANTA – Following a Mediterranean-style diet may reduce the risk of chronic kidney disease, findings from the prospective Northern Manhattan Study suggest.

Among 900 subjects from the large community-based, multiethnic cohort who had requisite data available, 14% developed new chronic kidney disease (CKD) during a mean follow-up of 6.9 years. After adjustment for several potential confounders, including demographics, medication use, laboratory values, and medical history, following a Mediterranean-style diet was associated with a 50% reduction in the risk of incident stage 3 CKD, the primary outcome measure of the study (odds ratio, 0.50), Dr. Minesh Khatri of Columbia University, New York, reported at Kidney Week 2013.

Furthermore, each 1-unit increase in a previously developed 9-point score that measured the degree to which a subject followed a Mediterranean-style diet (the MeDi score) was associated with a 17% reduction in CKD risk (OR, 0.83), Dr. Khatri said.

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Mediterranean diets may reduce the risk of chronic kidney disease, findings from the prospective Northern Manhattan Study suggest.

A MeDi score of 5 or higher also was associated with a 42% reduction in the risk of rapid kidney function decline (OR, 0.58), and each 1-point increase in the score was associated with a 12% reduction in risk (OR, 0.88).

Continuous absolute change in estimated glomerular filtration rate (eGFR) was not significantly affected by the MeDi score, but a higher score was associated with a trend toward improvement.

Study participants were adults who were stroke free and had a mean age of 64 years at baseline. They underwent measurement of serum creatinine at baseline and at follow-up, as well as brain magnetic resonance imaging at follow-up. They also completed a dietary questionnaire at baseline, from which the MeDi score was derived.

Most (65%) were Hispanic, and 59% were women. Mean eGFR was 83.1 mL/min, with a mean annualized decline of 1.1 mL/min.

Incident CKD in this study was defined as a follow-up Modification of Diet in Renal Disease eGFR of less than 60 mL/min among subjects with eGFR greater than 60 mL/min at baseline.

"CKD is highly prevalent. The lifetime risk of stage 3 CKD in the United States may be as high as 59% ... [and] the consequences of CKD are of equal magnitude. CKD increases the risk of morbidity and mortality, especially from cardiovascular disease," Dr. Khatri said. Data show that the worse the kidney function, the greater the cardiovascular disease risk and the greater the likelihood of cardiovascular events, he noted.

The financial toll is also extensive, he said during a press briefing at the conference, which was sponsored by the American Society of Nephrology.

"On top of this, the therapeutic armamentarium for CKD is actually relatively limited. We’ve made tremendous strides in treating traditional risk factors such as diabetes, hypertension, and protein in the urine, but most patients with CKD still have progressive kidney function decline over time. This therefore means we need novel approaches to prevent and ameliorate progression of CKD," he said.

Diet may be one such approach. Some diets have been studied in the context of improving CKD, but most studies have focused on protein restriction – an approach that may be harmful in some patients, such as the frail elderly. Few studies have looked at diet in the context of preventing CKD.

The Mediterranean diet – which generally includes high intake of fruits, vegetables, legumes, cereals, fish, and heart-healthy monounsaturated fats; lower intake of dairy, meats, and saturated fats; as well as moderate alcohol intake, has received a great deal of attention with respect to potential cardiovascular benefits. Studies have shown it has important benefits, including improvements in blood pressure, endothelial function, cholesterol, inflammation, and overall cardiovascular risk, Dr. Khatri said.

In fact, results from the randomized controlled PREDIMED study, published in April, demonstrated a 30% reduction in cardiovascular risk among those following a Mediterranean diet, compared with those following a standard low-fat diet (N. Engl. J. Med. 2013;368:1279-90), he noted.

The current study shows that a Mediterranean-style diet may have similarly beneficial effects for reducing CKD risk, which makes sense given the shared risk factors between CKD and cardiovascular disease, he said.

Larger observational trials and randomized controlled trials are needed to confirm these findings and to elucidate the mechanisms by which a Mediterranean-style diet may protect against kidney disease, he said.

This study was funded by the National Institutes of Health. Dr. Khatri reported having no disclosures.

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ATLANTA – Following a Mediterranean-style diet may reduce the risk of chronic kidney disease, findings from the prospective Northern Manhattan Study suggest.

Among 900 subjects from the large community-based, multiethnic cohort who had requisite data available, 14% developed new chronic kidney disease (CKD) during a mean follow-up of 6.9 years. After adjustment for several potential confounders, including demographics, medication use, laboratory values, and medical history, following a Mediterranean-style diet was associated with a 50% reduction in the risk of incident stage 3 CKD, the primary outcome measure of the study (odds ratio, 0.50), Dr. Minesh Khatri of Columbia University, New York, reported at Kidney Week 2013.

Furthermore, each 1-unit increase in a previously developed 9-point score that measured the degree to which a subject followed a Mediterranean-style diet (the MeDi score) was associated with a 17% reduction in CKD risk (OR, 0.83), Dr. Khatri said.

©Dušan Zidar/Fotolia.com
Mediterranean diets may reduce the risk of chronic kidney disease, findings from the prospective Northern Manhattan Study suggest.

A MeDi score of 5 or higher also was associated with a 42% reduction in the risk of rapid kidney function decline (OR, 0.58), and each 1-point increase in the score was associated with a 12% reduction in risk (OR, 0.88).

Continuous absolute change in estimated glomerular filtration rate (eGFR) was not significantly affected by the MeDi score, but a higher score was associated with a trend toward improvement.

Study participants were adults who were stroke free and had a mean age of 64 years at baseline. They underwent measurement of serum creatinine at baseline and at follow-up, as well as brain magnetic resonance imaging at follow-up. They also completed a dietary questionnaire at baseline, from which the MeDi score was derived.

Most (65%) were Hispanic, and 59% were women. Mean eGFR was 83.1 mL/min, with a mean annualized decline of 1.1 mL/min.

Incident CKD in this study was defined as a follow-up Modification of Diet in Renal Disease eGFR of less than 60 mL/min among subjects with eGFR greater than 60 mL/min at baseline.

"CKD is highly prevalent. The lifetime risk of stage 3 CKD in the United States may be as high as 59% ... [and] the consequences of CKD are of equal magnitude. CKD increases the risk of morbidity and mortality, especially from cardiovascular disease," Dr. Khatri said. Data show that the worse the kidney function, the greater the cardiovascular disease risk and the greater the likelihood of cardiovascular events, he noted.

The financial toll is also extensive, he said during a press briefing at the conference, which was sponsored by the American Society of Nephrology.

"On top of this, the therapeutic armamentarium for CKD is actually relatively limited. We’ve made tremendous strides in treating traditional risk factors such as diabetes, hypertension, and protein in the urine, but most patients with CKD still have progressive kidney function decline over time. This therefore means we need novel approaches to prevent and ameliorate progression of CKD," he said.

Diet may be one such approach. Some diets have been studied in the context of improving CKD, but most studies have focused on protein restriction – an approach that may be harmful in some patients, such as the frail elderly. Few studies have looked at diet in the context of preventing CKD.

The Mediterranean diet – which generally includes high intake of fruits, vegetables, legumes, cereals, fish, and heart-healthy monounsaturated fats; lower intake of dairy, meats, and saturated fats; as well as moderate alcohol intake, has received a great deal of attention with respect to potential cardiovascular benefits. Studies have shown it has important benefits, including improvements in blood pressure, endothelial function, cholesterol, inflammation, and overall cardiovascular risk, Dr. Khatri said.

In fact, results from the randomized controlled PREDIMED study, published in April, demonstrated a 30% reduction in cardiovascular risk among those following a Mediterranean diet, compared with those following a standard low-fat diet (N. Engl. J. Med. 2013;368:1279-90), he noted.

The current study shows that a Mediterranean-style diet may have similarly beneficial effects for reducing CKD risk, which makes sense given the shared risk factors between CKD and cardiovascular disease, he said.

Larger observational trials and randomized controlled trials are needed to confirm these findings and to elucidate the mechanisms by which a Mediterranean-style diet may protect against kidney disease, he said.

This study was funded by the National Institutes of Health. Dr. Khatri reported having no disclosures.

ATLANTA – Following a Mediterranean-style diet may reduce the risk of chronic kidney disease, findings from the prospective Northern Manhattan Study suggest.

Among 900 subjects from the large community-based, multiethnic cohort who had requisite data available, 14% developed new chronic kidney disease (CKD) during a mean follow-up of 6.9 years. After adjustment for several potential confounders, including demographics, medication use, laboratory values, and medical history, following a Mediterranean-style diet was associated with a 50% reduction in the risk of incident stage 3 CKD, the primary outcome measure of the study (odds ratio, 0.50), Dr. Minesh Khatri of Columbia University, New York, reported at Kidney Week 2013.

Furthermore, each 1-unit increase in a previously developed 9-point score that measured the degree to which a subject followed a Mediterranean-style diet (the MeDi score) was associated with a 17% reduction in CKD risk (OR, 0.83), Dr. Khatri said.

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Mediterranean diets may reduce the risk of chronic kidney disease, findings from the prospective Northern Manhattan Study suggest.

A MeDi score of 5 or higher also was associated with a 42% reduction in the risk of rapid kidney function decline (OR, 0.58), and each 1-point increase in the score was associated with a 12% reduction in risk (OR, 0.88).

Continuous absolute change in estimated glomerular filtration rate (eGFR) was not significantly affected by the MeDi score, but a higher score was associated with a trend toward improvement.

Study participants were adults who were stroke free and had a mean age of 64 years at baseline. They underwent measurement of serum creatinine at baseline and at follow-up, as well as brain magnetic resonance imaging at follow-up. They also completed a dietary questionnaire at baseline, from which the MeDi score was derived.

Most (65%) were Hispanic, and 59% were women. Mean eGFR was 83.1 mL/min, with a mean annualized decline of 1.1 mL/min.

Incident CKD in this study was defined as a follow-up Modification of Diet in Renal Disease eGFR of less than 60 mL/min among subjects with eGFR greater than 60 mL/min at baseline.

"CKD is highly prevalent. The lifetime risk of stage 3 CKD in the United States may be as high as 59% ... [and] the consequences of CKD are of equal magnitude. CKD increases the risk of morbidity and mortality, especially from cardiovascular disease," Dr. Khatri said. Data show that the worse the kidney function, the greater the cardiovascular disease risk and the greater the likelihood of cardiovascular events, he noted.

The financial toll is also extensive, he said during a press briefing at the conference, which was sponsored by the American Society of Nephrology.

"On top of this, the therapeutic armamentarium for CKD is actually relatively limited. We’ve made tremendous strides in treating traditional risk factors such as diabetes, hypertension, and protein in the urine, but most patients with CKD still have progressive kidney function decline over time. This therefore means we need novel approaches to prevent and ameliorate progression of CKD," he said.

Diet may be one such approach. Some diets have been studied in the context of improving CKD, but most studies have focused on protein restriction – an approach that may be harmful in some patients, such as the frail elderly. Few studies have looked at diet in the context of preventing CKD.

The Mediterranean diet – which generally includes high intake of fruits, vegetables, legumes, cereals, fish, and heart-healthy monounsaturated fats; lower intake of dairy, meats, and saturated fats; as well as moderate alcohol intake, has received a great deal of attention with respect to potential cardiovascular benefits. Studies have shown it has important benefits, including improvements in blood pressure, endothelial function, cholesterol, inflammation, and overall cardiovascular risk, Dr. Khatri said.

In fact, results from the randomized controlled PREDIMED study, published in April, demonstrated a 30% reduction in cardiovascular risk among those following a Mediterranean diet, compared with those following a standard low-fat diet (N. Engl. J. Med. 2013;368:1279-90), he noted.

The current study shows that a Mediterranean-style diet may have similarly beneficial effects for reducing CKD risk, which makes sense given the shared risk factors between CKD and cardiovascular disease, he said.

Larger observational trials and randomized controlled trials are needed to confirm these findings and to elucidate the mechanisms by which a Mediterranean-style diet may protect against kidney disease, he said.

This study was funded by the National Institutes of Health. Dr. Khatri reported having no disclosures.

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Major finding: A Mediterranean-style diet was associated with a 50% reduction in incident CKD.

Data source: A prospective cohort study involving 900 subjects.

Disclosures: This study was funded by the National Institutes of Health. Dr. Khatri reported having no disclosures.

Women’s health groups propose new term for ‘vulvovaginal atrophy’

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To varying degrees, vulvovaginal atrophy affects an estimated 20%-40% of menopausal women, but the name of the condition fails to appropriately characterize the range of associated signs and symptoms that women may experience.

Representatives from the North American Menopause Society (NAMS) and the International Society for the Study of Women’s Sexual Health, Inc. (ISSWSH) propose a new term: genitourinary syndrome of menopause, or GSM.

Earlier this year, the two organizations convened a 2-day consensus conference to consider what an appropriate term would encompass. The goal of that conference, according to Dr. Margery Gass of the Cleveland Clinic Center for Specialized Women’s Health and the executive director of NAMS, was to identify a term that was descriptive, comprehensive, and suitable for professionals, consumers, and the media.

Dr. Margery Gass

Participants reviewed the symptoms and signs of genitourinary aging and the available relevant data, and decided on a number of components that should be covered by the new nomenclature, including the affected anatomy, descriptive factors, problems caused by the condition, and context with respect to life phase, she said in an interview.

Dr. Gass and Dr. David J. Portman, director of the Columbus Center for Women’s Health Research and an adjunct instructor at Ohio State University, Columbus, cochaired the consensus conference. They presented the conclusions from the conference at the annual meeting of the North American Menopause Society in October.

"Several concerns have forced the issue of a name change for this condition," Dr. Gass said, noting that persistent societal resistance to openly discussing women’s sexuality and sexual health is not the least among them.

The word "vagina," for example, still can’t be uttered in many media outlets, she explained. Additionally, the term "atrophy" has unpleasant connotations that aren’t necessarily reflective of the experience of women affected by the condition, she noted.

"In fact, atrophy in and of itself is a natural part of aging – something many women experience – and is not necessarily a problem; some women with atrophy experience no symptoms, while others experience significant symptoms.

"We feel that the name we’re putting forward (genitourinary syndrome of menopause) very accurately describes the parts of the body that are involved – namely the genital system and the lower urinary tract," she said.

The use of the word "syndrome" further allows for a diagnosis based on the range of symptoms women may experience, and doesn’t limit the condition to specific symptoms.

"This is not a disease or a deficiency, so we think ‘genitourinary syndrome of menopause’ is a neutral term that would be acceptable, Dr. Gass said.

A change in the nomenclature could potentially open the door to more productive, health-promoting dialogue. During his presentation at the NAMS meeting, Dr. Portman explained how a term that is more acceptable to patients and the media could have the power to start the conversation, change attitudes, and promote understanding and acceptance of more open communication. He used male sexual dysfunction as an example.

In 1992, a National Institutes of Health consensus development panel determined that the term "erectile dysfunction" was preferable to the term "impotence." Indeed, along with the subsequent approval of Viagra and other drugs related to male sexual health, the term "erectile dysfunction" is now widely used in advertising, promoted by politicians and celebrities, and openly discussed in the community, he said.

In contrast, open discussion about women’s sexuality and sexual health remains constrained. In fact, in a survey of more than 1,000 women – including 330 women aged 60-65 years – 75% "completely agreed" that society constrains the sexual expression of "women my age more so than men my age." Nearly as many completely agreed that society is more accepting of discussion around men’s physical sexual problems than women’s physical sexual problems. More than half completely agreed that "society would prefer to believe that women my age do not have sex."

The use of more "socially acceptable" terminology (the word "penis," like "vagina," is still not used openly, Dr. Gass noted) helped make male sexual health a mainstream topic; it is hoped that transitioning from "vulvovaginal atrophy" to "genitourinary syndrome of menopause," would have a similar effect with respect to women’s sexual health, Dr. Portman said.

GSM would be defined as "a collection of symptoms and signs associated with decreased estrogen levels that can involve the labia majora/minora, vestibule/introitus, clitoris, vagina, urethra, and bladder," conference attendees agreed.

It is a syndrome for which treatment is indicated if symptoms are bothersome; treatment should be individualized based on the severity of symptoms and the woman’s preference after discussion of treatment options and risks and benefits.

 

 

In addition to working toward agreement on appropriate nomenclature, the consensus conference participants are developing an assessment tool, currently in draft form, to aid clinicians in evaluating women for the syndrome.

"We feel we’ve identified a number of signs and findings that would help clinicians – particularly those who don’t treat a lot of patients with this condition. The tool – which involves a grid-based design outlining mild, moderate, and severe symptom categories – may prove valuable for providers who want to chart severity or just scan the grid to assist in making a diagnosis," Dr. Gass said. The tool also could prove useful in the research setting, he added.

ISSWSH and NAMS will be publishing the proceedings of the workshop in upcoming issues of their respective journals – the Journal of Sexual Medicine and the journal Menopause.

The groups also plan to put forward the proposed new name at a December meeting of the American College of Obstetricians and Gynecologists. At that meeting, ACOG will review all terminology related to obstetrics and gynecology and update terminology as appropriate.

"We hope to address the ACOG urogynecology and menopause working group to see if the new name is acceptable to that group as well. Personally I think it’s important to have an accurate term that is as neutral as possible," Dr. Gass said.

Dr. Gass reported having no disclosures. Dr. Portman has been a speaker, consultant, or advisory board member for, and/or received grant or research support from Bayer, Noven Pharmaceuticals, Palatin Technologies, and other companies.

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To varying degrees, vulvovaginal atrophy affects an estimated 20%-40% of menopausal women, but the name of the condition fails to appropriately characterize the range of associated signs and symptoms that women may experience.

Representatives from the North American Menopause Society (NAMS) and the International Society for the Study of Women’s Sexual Health, Inc. (ISSWSH) propose a new term: genitourinary syndrome of menopause, or GSM.

Earlier this year, the two organizations convened a 2-day consensus conference to consider what an appropriate term would encompass. The goal of that conference, according to Dr. Margery Gass of the Cleveland Clinic Center for Specialized Women’s Health and the executive director of NAMS, was to identify a term that was descriptive, comprehensive, and suitable for professionals, consumers, and the media.

Dr. Margery Gass

Participants reviewed the symptoms and signs of genitourinary aging and the available relevant data, and decided on a number of components that should be covered by the new nomenclature, including the affected anatomy, descriptive factors, problems caused by the condition, and context with respect to life phase, she said in an interview.

Dr. Gass and Dr. David J. Portman, director of the Columbus Center for Women’s Health Research and an adjunct instructor at Ohio State University, Columbus, cochaired the consensus conference. They presented the conclusions from the conference at the annual meeting of the North American Menopause Society in October.

"Several concerns have forced the issue of a name change for this condition," Dr. Gass said, noting that persistent societal resistance to openly discussing women’s sexuality and sexual health is not the least among them.

The word "vagina," for example, still can’t be uttered in many media outlets, she explained. Additionally, the term "atrophy" has unpleasant connotations that aren’t necessarily reflective of the experience of women affected by the condition, she noted.

"In fact, atrophy in and of itself is a natural part of aging – something many women experience – and is not necessarily a problem; some women with atrophy experience no symptoms, while others experience significant symptoms.

"We feel that the name we’re putting forward (genitourinary syndrome of menopause) very accurately describes the parts of the body that are involved – namely the genital system and the lower urinary tract," she said.

The use of the word "syndrome" further allows for a diagnosis based on the range of symptoms women may experience, and doesn’t limit the condition to specific symptoms.

"This is not a disease or a deficiency, so we think ‘genitourinary syndrome of menopause’ is a neutral term that would be acceptable, Dr. Gass said.

A change in the nomenclature could potentially open the door to more productive, health-promoting dialogue. During his presentation at the NAMS meeting, Dr. Portman explained how a term that is more acceptable to patients and the media could have the power to start the conversation, change attitudes, and promote understanding and acceptance of more open communication. He used male sexual dysfunction as an example.

In 1992, a National Institutes of Health consensus development panel determined that the term "erectile dysfunction" was preferable to the term "impotence." Indeed, along with the subsequent approval of Viagra and other drugs related to male sexual health, the term "erectile dysfunction" is now widely used in advertising, promoted by politicians and celebrities, and openly discussed in the community, he said.

In contrast, open discussion about women’s sexuality and sexual health remains constrained. In fact, in a survey of more than 1,000 women – including 330 women aged 60-65 years – 75% "completely agreed" that society constrains the sexual expression of "women my age more so than men my age." Nearly as many completely agreed that society is more accepting of discussion around men’s physical sexual problems than women’s physical sexual problems. More than half completely agreed that "society would prefer to believe that women my age do not have sex."

The use of more "socially acceptable" terminology (the word "penis," like "vagina," is still not used openly, Dr. Gass noted) helped make male sexual health a mainstream topic; it is hoped that transitioning from "vulvovaginal atrophy" to "genitourinary syndrome of menopause," would have a similar effect with respect to women’s sexual health, Dr. Portman said.

GSM would be defined as "a collection of symptoms and signs associated with decreased estrogen levels that can involve the labia majora/minora, vestibule/introitus, clitoris, vagina, urethra, and bladder," conference attendees agreed.

It is a syndrome for which treatment is indicated if symptoms are bothersome; treatment should be individualized based on the severity of symptoms and the woman’s preference after discussion of treatment options and risks and benefits.

 

 

In addition to working toward agreement on appropriate nomenclature, the consensus conference participants are developing an assessment tool, currently in draft form, to aid clinicians in evaluating women for the syndrome.

"We feel we’ve identified a number of signs and findings that would help clinicians – particularly those who don’t treat a lot of patients with this condition. The tool – which involves a grid-based design outlining mild, moderate, and severe symptom categories – may prove valuable for providers who want to chart severity or just scan the grid to assist in making a diagnosis," Dr. Gass said. The tool also could prove useful in the research setting, he added.

ISSWSH and NAMS will be publishing the proceedings of the workshop in upcoming issues of their respective journals – the Journal of Sexual Medicine and the journal Menopause.

The groups also plan to put forward the proposed new name at a December meeting of the American College of Obstetricians and Gynecologists. At that meeting, ACOG will review all terminology related to obstetrics and gynecology and update terminology as appropriate.

"We hope to address the ACOG urogynecology and menopause working group to see if the new name is acceptable to that group as well. Personally I think it’s important to have an accurate term that is as neutral as possible," Dr. Gass said.

Dr. Gass reported having no disclosures. Dr. Portman has been a speaker, consultant, or advisory board member for, and/or received grant or research support from Bayer, Noven Pharmaceuticals, Palatin Technologies, and other companies.

To varying degrees, vulvovaginal atrophy affects an estimated 20%-40% of menopausal women, but the name of the condition fails to appropriately characterize the range of associated signs and symptoms that women may experience.

Representatives from the North American Menopause Society (NAMS) and the International Society for the Study of Women’s Sexual Health, Inc. (ISSWSH) propose a new term: genitourinary syndrome of menopause, or GSM.

Earlier this year, the two organizations convened a 2-day consensus conference to consider what an appropriate term would encompass. The goal of that conference, according to Dr. Margery Gass of the Cleveland Clinic Center for Specialized Women’s Health and the executive director of NAMS, was to identify a term that was descriptive, comprehensive, and suitable for professionals, consumers, and the media.

Dr. Margery Gass

Participants reviewed the symptoms and signs of genitourinary aging and the available relevant data, and decided on a number of components that should be covered by the new nomenclature, including the affected anatomy, descriptive factors, problems caused by the condition, and context with respect to life phase, she said in an interview.

Dr. Gass and Dr. David J. Portman, director of the Columbus Center for Women’s Health Research and an adjunct instructor at Ohio State University, Columbus, cochaired the consensus conference. They presented the conclusions from the conference at the annual meeting of the North American Menopause Society in October.

"Several concerns have forced the issue of a name change for this condition," Dr. Gass said, noting that persistent societal resistance to openly discussing women’s sexuality and sexual health is not the least among them.

The word "vagina," for example, still can’t be uttered in many media outlets, she explained. Additionally, the term "atrophy" has unpleasant connotations that aren’t necessarily reflective of the experience of women affected by the condition, she noted.

"In fact, atrophy in and of itself is a natural part of aging – something many women experience – and is not necessarily a problem; some women with atrophy experience no symptoms, while others experience significant symptoms.

"We feel that the name we’re putting forward (genitourinary syndrome of menopause) very accurately describes the parts of the body that are involved – namely the genital system and the lower urinary tract," she said.

The use of the word "syndrome" further allows for a diagnosis based on the range of symptoms women may experience, and doesn’t limit the condition to specific symptoms.

"This is not a disease or a deficiency, so we think ‘genitourinary syndrome of menopause’ is a neutral term that would be acceptable, Dr. Gass said.

A change in the nomenclature could potentially open the door to more productive, health-promoting dialogue. During his presentation at the NAMS meeting, Dr. Portman explained how a term that is more acceptable to patients and the media could have the power to start the conversation, change attitudes, and promote understanding and acceptance of more open communication. He used male sexual dysfunction as an example.

In 1992, a National Institutes of Health consensus development panel determined that the term "erectile dysfunction" was preferable to the term "impotence." Indeed, along with the subsequent approval of Viagra and other drugs related to male sexual health, the term "erectile dysfunction" is now widely used in advertising, promoted by politicians and celebrities, and openly discussed in the community, he said.

In contrast, open discussion about women’s sexuality and sexual health remains constrained. In fact, in a survey of more than 1,000 women – including 330 women aged 60-65 years – 75% "completely agreed" that society constrains the sexual expression of "women my age more so than men my age." Nearly as many completely agreed that society is more accepting of discussion around men’s physical sexual problems than women’s physical sexual problems. More than half completely agreed that "society would prefer to believe that women my age do not have sex."

The use of more "socially acceptable" terminology (the word "penis," like "vagina," is still not used openly, Dr. Gass noted) helped make male sexual health a mainstream topic; it is hoped that transitioning from "vulvovaginal atrophy" to "genitourinary syndrome of menopause," would have a similar effect with respect to women’s sexual health, Dr. Portman said.

GSM would be defined as "a collection of symptoms and signs associated with decreased estrogen levels that can involve the labia majora/minora, vestibule/introitus, clitoris, vagina, urethra, and bladder," conference attendees agreed.

It is a syndrome for which treatment is indicated if symptoms are bothersome; treatment should be individualized based on the severity of symptoms and the woman’s preference after discussion of treatment options and risks and benefits.

 

 

In addition to working toward agreement on appropriate nomenclature, the consensus conference participants are developing an assessment tool, currently in draft form, to aid clinicians in evaluating women for the syndrome.

"We feel we’ve identified a number of signs and findings that would help clinicians – particularly those who don’t treat a lot of patients with this condition. The tool – which involves a grid-based design outlining mild, moderate, and severe symptom categories – may prove valuable for providers who want to chart severity or just scan the grid to assist in making a diagnosis," Dr. Gass said. The tool also could prove useful in the research setting, he added.

ISSWSH and NAMS will be publishing the proceedings of the workshop in upcoming issues of their respective journals – the Journal of Sexual Medicine and the journal Menopause.

The groups also plan to put forward the proposed new name at a December meeting of the American College of Obstetricians and Gynecologists. At that meeting, ACOG will review all terminology related to obstetrics and gynecology and update terminology as appropriate.

"We hope to address the ACOG urogynecology and menopause working group to see if the new name is acceptable to that group as well. Personally I think it’s important to have an accurate term that is as neutral as possible," Dr. Gass said.

Dr. Gass reported having no disclosures. Dr. Portman has been a speaker, consultant, or advisory board member for, and/or received grant or research support from Bayer, Noven Pharmaceuticals, Palatin Technologies, and other companies.

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Microarray is ‘go-to’ test for multiple congenital anomalies

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ORLANDO – Chromosomal microarray testing is ideal for narrowing down the diagnosis in most patients presenting with multiple congenital anomalies, according to Dr. Laurie Demmer.

"Microarray is the clinical geneticist’s favorite test right now. We order it every day – anytime we see somebody with multiple congenital anomalies, unless it’s obviously Down syndrome or another obvious syndrome," Dr. Demmer said during a "Genetic Testing Boot Camp" session at the annual meeting of the American Academy of Pediatrics.

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Chromosomal microarray testing is ideal for narrowing down the diagnosis in most patients presenting with multiple congenital anomalies, according to Dr. Laurie Demmer.

For children presenting with a suspected syndrome, problems with growth, or a development or autism spectrum disorder, microarray is "really our go-to test right now," said Dr. Demmer, a pediatric clinical geneticist at Levine Children’s Hospital, Charlotte, N.C.

Also, if chromosomal testing demonstrates a certain karyotype, such as a translocation, then microarray testing is the best approach for determining if it is a balanced translocation. If a marker chromosome is detected, microarray will identify it.

Like karyotyping, which is often used when a chromosomal anomaly is suspected, microarray testing provides a look at the whole genome, but it is about 100 times more sensitive than a karyotype. It is high resolution like fluorescent in situ hybridization (FISH), which is a chromosomal testing method often used when a quicker answer is needed to help guide management.

Thus, microarray testing is "kind of the best of both worlds," Dr. Demmer said, adding that with microarray analysis, it is possible to look for small deletions and duplications on all the chromosomes within the whole genome.

At first, microarray testing was targeted; rather than looking at the whole genome, testing was performed to look for known syndromes such as 22q deletions and Williams syndrome and Smith-Magenis syndrome, for example. Expanding the view to the whole genome has allowed for diagnosis of new syndromes that were never known before.

"Every week I get one or two arrays back that are abnormal with a new deletion or duplication that I’d never seen or heard of before," she said, noting that a downside of this is that there’s no clear answer to what should be done with all of these "copy number variants." Currently they are being characterized in databases as a reference.

The latest generation of microarray testing (single nucleotide polymorphism, or SNP array) provides qualitative information not available with oligoarray testing.

"It allows us to tell the difference between chromosomes. ... It gives us the ability to tell if there is identity in the chromosomes," she said, explaining that this may mean identifying uniparental disomy (and likely Prader-Willi syndrome), consanguinity (and degree of relationship), and other circumstances associated with autosomal recessive disease.

A downside of microarray testing is that it only looks for deletions and duplications, and therefore does not detect balanced rearrangements. Thus a balanced translocation will not be detected on microarray testing, and an opportunity for genetic counseling could be missed.

Also, sometimes a copy number variant or deletion or duplication is found, and it is unclear how these should be interpreted.

A general rule of thumb, however, is that the bigger it is, the more likely it is to be significant, Dr. Demmer said, noting that in some of these cases, the parents are tested, and if a parent has the same copy number variant but is normal, the finding is usually a benign change.

Dr. Laurie Demmer

Sometimes, however, a parent who has the copy number variant may be "on the spectrum somewhere, but not actually diagnosed, and they may have one of the changes associated with autism."

These cases require special care in interpretation, Dr. Demmer said. "If you’re going to send out for microarrays in your office and it comes back normal, that’s great, but if it comes back anything else, you may want to get a geneticist to help you," she said.

Similarly, unanticipated results – incidental findings – also occur, and these can be tricky to deal with. Examples include cases of unknown consanguinity and incest, she said.

Sometimes the incidental findings lead to improved outcomes. Dr. Demmer described one case involving an intellectually disabled 10-year-old girl who was incidentally found on microarray testing to be at genetic risk for familial adenomatous polyposis (FAP). A gastrointestinal examination showed that she already had thousands of polyps.

"So she has FAP, which we diagnosed by doing the microarray, and probably saved her life, because now we will treat her, and we’re going to prevent the colon cancer," she said.

 

 

Dr. Demmer reported having no disclosures.

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ORLANDO – Chromosomal microarray testing is ideal for narrowing down the diagnosis in most patients presenting with multiple congenital anomalies, according to Dr. Laurie Demmer.

"Microarray is the clinical geneticist’s favorite test right now. We order it every day – anytime we see somebody with multiple congenital anomalies, unless it’s obviously Down syndrome or another obvious syndrome," Dr. Demmer said during a "Genetic Testing Boot Camp" session at the annual meeting of the American Academy of Pediatrics.

© nantela/iStockphoto.com
Chromosomal microarray testing is ideal for narrowing down the diagnosis in most patients presenting with multiple congenital anomalies, according to Dr. Laurie Demmer.

For children presenting with a suspected syndrome, problems with growth, or a development or autism spectrum disorder, microarray is "really our go-to test right now," said Dr. Demmer, a pediatric clinical geneticist at Levine Children’s Hospital, Charlotte, N.C.

Also, if chromosomal testing demonstrates a certain karyotype, such as a translocation, then microarray testing is the best approach for determining if it is a balanced translocation. If a marker chromosome is detected, microarray will identify it.

Like karyotyping, which is often used when a chromosomal anomaly is suspected, microarray testing provides a look at the whole genome, but it is about 100 times more sensitive than a karyotype. It is high resolution like fluorescent in situ hybridization (FISH), which is a chromosomal testing method often used when a quicker answer is needed to help guide management.

Thus, microarray testing is "kind of the best of both worlds," Dr. Demmer said, adding that with microarray analysis, it is possible to look for small deletions and duplications on all the chromosomes within the whole genome.

At first, microarray testing was targeted; rather than looking at the whole genome, testing was performed to look for known syndromes such as 22q deletions and Williams syndrome and Smith-Magenis syndrome, for example. Expanding the view to the whole genome has allowed for diagnosis of new syndromes that were never known before.

"Every week I get one or two arrays back that are abnormal with a new deletion or duplication that I’d never seen or heard of before," she said, noting that a downside of this is that there’s no clear answer to what should be done with all of these "copy number variants." Currently they are being characterized in databases as a reference.

The latest generation of microarray testing (single nucleotide polymorphism, or SNP array) provides qualitative information not available with oligoarray testing.

"It allows us to tell the difference between chromosomes. ... It gives us the ability to tell if there is identity in the chromosomes," she said, explaining that this may mean identifying uniparental disomy (and likely Prader-Willi syndrome), consanguinity (and degree of relationship), and other circumstances associated with autosomal recessive disease.

A downside of microarray testing is that it only looks for deletions and duplications, and therefore does not detect balanced rearrangements. Thus a balanced translocation will not be detected on microarray testing, and an opportunity for genetic counseling could be missed.

Also, sometimes a copy number variant or deletion or duplication is found, and it is unclear how these should be interpreted.

A general rule of thumb, however, is that the bigger it is, the more likely it is to be significant, Dr. Demmer said, noting that in some of these cases, the parents are tested, and if a parent has the same copy number variant but is normal, the finding is usually a benign change.

Dr. Laurie Demmer

Sometimes, however, a parent who has the copy number variant may be "on the spectrum somewhere, but not actually diagnosed, and they may have one of the changes associated with autism."

These cases require special care in interpretation, Dr. Demmer said. "If you’re going to send out for microarrays in your office and it comes back normal, that’s great, but if it comes back anything else, you may want to get a geneticist to help you," she said.

Similarly, unanticipated results – incidental findings – also occur, and these can be tricky to deal with. Examples include cases of unknown consanguinity and incest, she said.

Sometimes the incidental findings lead to improved outcomes. Dr. Demmer described one case involving an intellectually disabled 10-year-old girl who was incidentally found on microarray testing to be at genetic risk for familial adenomatous polyposis (FAP). A gastrointestinal examination showed that she already had thousands of polyps.

"So she has FAP, which we diagnosed by doing the microarray, and probably saved her life, because now we will treat her, and we’re going to prevent the colon cancer," she said.

 

 

Dr. Demmer reported having no disclosures.

ORLANDO – Chromosomal microarray testing is ideal for narrowing down the diagnosis in most patients presenting with multiple congenital anomalies, according to Dr. Laurie Demmer.

"Microarray is the clinical geneticist’s favorite test right now. We order it every day – anytime we see somebody with multiple congenital anomalies, unless it’s obviously Down syndrome or another obvious syndrome," Dr. Demmer said during a "Genetic Testing Boot Camp" session at the annual meeting of the American Academy of Pediatrics.

© nantela/iStockphoto.com
Chromosomal microarray testing is ideal for narrowing down the diagnosis in most patients presenting with multiple congenital anomalies, according to Dr. Laurie Demmer.

For children presenting with a suspected syndrome, problems with growth, or a development or autism spectrum disorder, microarray is "really our go-to test right now," said Dr. Demmer, a pediatric clinical geneticist at Levine Children’s Hospital, Charlotte, N.C.

Also, if chromosomal testing demonstrates a certain karyotype, such as a translocation, then microarray testing is the best approach for determining if it is a balanced translocation. If a marker chromosome is detected, microarray will identify it.

Like karyotyping, which is often used when a chromosomal anomaly is suspected, microarray testing provides a look at the whole genome, but it is about 100 times more sensitive than a karyotype. It is high resolution like fluorescent in situ hybridization (FISH), which is a chromosomal testing method often used when a quicker answer is needed to help guide management.

Thus, microarray testing is "kind of the best of both worlds," Dr. Demmer said, adding that with microarray analysis, it is possible to look for small deletions and duplications on all the chromosomes within the whole genome.

At first, microarray testing was targeted; rather than looking at the whole genome, testing was performed to look for known syndromes such as 22q deletions and Williams syndrome and Smith-Magenis syndrome, for example. Expanding the view to the whole genome has allowed for diagnosis of new syndromes that were never known before.

"Every week I get one or two arrays back that are abnormal with a new deletion or duplication that I’d never seen or heard of before," she said, noting that a downside of this is that there’s no clear answer to what should be done with all of these "copy number variants." Currently they are being characterized in databases as a reference.

The latest generation of microarray testing (single nucleotide polymorphism, or SNP array) provides qualitative information not available with oligoarray testing.

"It allows us to tell the difference between chromosomes. ... It gives us the ability to tell if there is identity in the chromosomes," she said, explaining that this may mean identifying uniparental disomy (and likely Prader-Willi syndrome), consanguinity (and degree of relationship), and other circumstances associated with autosomal recessive disease.

A downside of microarray testing is that it only looks for deletions and duplications, and therefore does not detect balanced rearrangements. Thus a balanced translocation will not be detected on microarray testing, and an opportunity for genetic counseling could be missed.

Also, sometimes a copy number variant or deletion or duplication is found, and it is unclear how these should be interpreted.

A general rule of thumb, however, is that the bigger it is, the more likely it is to be significant, Dr. Demmer said, noting that in some of these cases, the parents are tested, and if a parent has the same copy number variant but is normal, the finding is usually a benign change.

Dr. Laurie Demmer

Sometimes, however, a parent who has the copy number variant may be "on the spectrum somewhere, but not actually diagnosed, and they may have one of the changes associated with autism."

These cases require special care in interpretation, Dr. Demmer said. "If you’re going to send out for microarrays in your office and it comes back normal, that’s great, but if it comes back anything else, you may want to get a geneticist to help you," she said.

Similarly, unanticipated results – incidental findings – also occur, and these can be tricky to deal with. Examples include cases of unknown consanguinity and incest, she said.

Sometimes the incidental findings lead to improved outcomes. Dr. Demmer described one case involving an intellectually disabled 10-year-old girl who was incidentally found on microarray testing to be at genetic risk for familial adenomatous polyposis (FAP). A gastrointestinal examination showed that she already had thousands of polyps.

"So she has FAP, which we diagnosed by doing the microarray, and probably saved her life, because now we will treat her, and we’re going to prevent the colon cancer," she said.

 

 

Dr. Demmer reported having no disclosures.

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Pediatric firearm injuries vary by age

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ORLANDO – The majority of children and adolescents who presented with firearm-related injuries to an urban level 1 trauma center over a 6-year period were black males over age 14 years according to a retrospective review of patient records.

Furthermore, children aged 14 years and younger were more likely than were older children to be shot at home, Dr. Andrea C. Suen reported at the annual meeting of the American Academy of Pediatrics.

The findings, which also characterized other age-related injury patterns, injury sites, and methods of transportation to the hospital, provide important information that could help in the development of effective crime- and injury-prevention strategies, she said.

Of 456 patients aged 18 years and younger who presented to the trauma center between January 2005 and 2010, 78 were aged 14 years or younger and 378 were aged 15-18 years. Overall, 86% were male, and 80% were black, but these figures differed by age group; 72% and 89% of those 14 years and younger and those 15-18 years, respectively, were male, and 64% and 83% of those 14 years and younger and those 15-18 years, respectively, were black, said Dr. Suen, a third-year pediatric emergency medicine fellow at the University of Florida Health Science Center, Jacksonville.

Those aged 14 years and younger were almost four times more likely to be shot at home (odds ratio, 3.76), and were much more likely to arrive by ambulance than by private car or to walk in than those aged 15-18 years.

The most common injury sites among children under age 14 years were the extremities (51% of cases), the trunk (41%), the head (16%), and the neck (9%). Those aged 5-9 years had a greater than sixfold increase in the likelihood of multiple injury sites, compared with those aged 10-14 years (OR, 6.26), she said.

In both age groups, 7.1% of patients died as a result of their injury.

In nearly 70% of cases, the shooter was someone unknown to the patient, and in 64% of cases, the type of firearm was unknown.

The findings of this study illustrate important age-based differences in firearm injuries, and highlight a need for improved reporting in firearm-related incidents, according to primary author and investigator, Dr. Phyllis Hendry of the department of emergency medicine at the university, who noted that hospital and emergency medical services reports in this study often lacked important details – such as patient’s relationship to the shooter and type of gun used – necessary for development of effective prevention strategies.

In an interview, Dr. Hendry further noted that the findings underscore the need for pediatricians to address gun safety and precautions in the home, as firearm-related injuries in children and adolescents are an important cause of preventable injury and mortality.

Also, emergency physicians should consider making a referral to child protective services on pediatric firearm injuries to assess the safety of the home, she said. "In our study, only 13% of patients 0-14 years of age had child-protection referrals documented."

Dr. Suen and Dr. Hendry reported having no disclosures.

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ORLANDO – The majority of children and adolescents who presented with firearm-related injuries to an urban level 1 trauma center over a 6-year period were black males over age 14 years according to a retrospective review of patient records.

Furthermore, children aged 14 years and younger were more likely than were older children to be shot at home, Dr. Andrea C. Suen reported at the annual meeting of the American Academy of Pediatrics.

The findings, which also characterized other age-related injury patterns, injury sites, and methods of transportation to the hospital, provide important information that could help in the development of effective crime- and injury-prevention strategies, she said.

Of 456 patients aged 18 years and younger who presented to the trauma center between January 2005 and 2010, 78 were aged 14 years or younger and 378 were aged 15-18 years. Overall, 86% were male, and 80% were black, but these figures differed by age group; 72% and 89% of those 14 years and younger and those 15-18 years, respectively, were male, and 64% and 83% of those 14 years and younger and those 15-18 years, respectively, were black, said Dr. Suen, a third-year pediatric emergency medicine fellow at the University of Florida Health Science Center, Jacksonville.

Those aged 14 years and younger were almost four times more likely to be shot at home (odds ratio, 3.76), and were much more likely to arrive by ambulance than by private car or to walk in than those aged 15-18 years.

The most common injury sites among children under age 14 years were the extremities (51% of cases), the trunk (41%), the head (16%), and the neck (9%). Those aged 5-9 years had a greater than sixfold increase in the likelihood of multiple injury sites, compared with those aged 10-14 years (OR, 6.26), she said.

In both age groups, 7.1% of patients died as a result of their injury.

In nearly 70% of cases, the shooter was someone unknown to the patient, and in 64% of cases, the type of firearm was unknown.

The findings of this study illustrate important age-based differences in firearm injuries, and highlight a need for improved reporting in firearm-related incidents, according to primary author and investigator, Dr. Phyllis Hendry of the department of emergency medicine at the university, who noted that hospital and emergency medical services reports in this study often lacked important details – such as patient’s relationship to the shooter and type of gun used – necessary for development of effective prevention strategies.

In an interview, Dr. Hendry further noted that the findings underscore the need for pediatricians to address gun safety and precautions in the home, as firearm-related injuries in children and adolescents are an important cause of preventable injury and mortality.

Also, emergency physicians should consider making a referral to child protective services on pediatric firearm injuries to assess the safety of the home, she said. "In our study, only 13% of patients 0-14 years of age had child-protection referrals documented."

Dr. Suen and Dr. Hendry reported having no disclosures.

ORLANDO – The majority of children and adolescents who presented with firearm-related injuries to an urban level 1 trauma center over a 6-year period were black males over age 14 years according to a retrospective review of patient records.

Furthermore, children aged 14 years and younger were more likely than were older children to be shot at home, Dr. Andrea C. Suen reported at the annual meeting of the American Academy of Pediatrics.

The findings, which also characterized other age-related injury patterns, injury sites, and methods of transportation to the hospital, provide important information that could help in the development of effective crime- and injury-prevention strategies, she said.

Of 456 patients aged 18 years and younger who presented to the trauma center between January 2005 and 2010, 78 were aged 14 years or younger and 378 were aged 15-18 years. Overall, 86% were male, and 80% were black, but these figures differed by age group; 72% and 89% of those 14 years and younger and those 15-18 years, respectively, were male, and 64% and 83% of those 14 years and younger and those 15-18 years, respectively, were black, said Dr. Suen, a third-year pediatric emergency medicine fellow at the University of Florida Health Science Center, Jacksonville.

Those aged 14 years and younger were almost four times more likely to be shot at home (odds ratio, 3.76), and were much more likely to arrive by ambulance than by private car or to walk in than those aged 15-18 years.

The most common injury sites among children under age 14 years were the extremities (51% of cases), the trunk (41%), the head (16%), and the neck (9%). Those aged 5-9 years had a greater than sixfold increase in the likelihood of multiple injury sites, compared with those aged 10-14 years (OR, 6.26), she said.

In both age groups, 7.1% of patients died as a result of their injury.

In nearly 70% of cases, the shooter was someone unknown to the patient, and in 64% of cases, the type of firearm was unknown.

The findings of this study illustrate important age-based differences in firearm injuries, and highlight a need for improved reporting in firearm-related incidents, according to primary author and investigator, Dr. Phyllis Hendry of the department of emergency medicine at the university, who noted that hospital and emergency medical services reports in this study often lacked important details – such as patient’s relationship to the shooter and type of gun used – necessary for development of effective prevention strategies.

In an interview, Dr. Hendry further noted that the findings underscore the need for pediatricians to address gun safety and precautions in the home, as firearm-related injuries in children and adolescents are an important cause of preventable injury and mortality.

Also, emergency physicians should consider making a referral to child protective services on pediatric firearm injuries to assess the safety of the home, she said. "In our study, only 13% of patients 0-14 years of age had child-protection referrals documented."

Dr. Suen and Dr. Hendry reported having no disclosures.

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children and adolescents, presented with firearm-related injuries, urban level 1 trauma center, black males, over age 14 years, 14 years and younger, shot at home, Dr. Andrea C. Suen, annual meeting of the American Academy of Pediatrics, age-related injury patterns, injury sites, methods of transportation to the hospital, crime- and injury-prevention strategies,

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Major finding: Children aged 14 years and under who experience firearm-related injury are more likely than are older children to be shot at home.

Data source: A retrospective review involving 456 patients.

Disclosures: Dr. Suen and Dr. Hendry reported having no disclosures.

Age-based differences seen in effects of PCV13

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SAN FRANCISCO – The incidence of invasive pneumococcal disease among children is declining in the wake of the 2010 introduction of the 13-valent pneumococcal conjugate vaccine, surveillance data suggest.

In New York City during 2011-2012, for example, the incidence of invasive pneumococcal disease (IPD) declined among children under age 5 across all age categories and race/ethnicity groups, Andrea Farnham of the New York City Department of Health and Mental Hygiene reported in a poster at an annual scientific meeting on infectious diseases.

The decline was driven by a reduction in 13-valent pneumococcal conjugate vaccine (PCV13)-type IPD and was temporally associated with the introduction and increased uptake of PCV13 vaccine, she said.

IPD incidence decreased by 70% (from 21.0 to 6.4 cases/100,000) between 2007-2009 and 2011-2012, and PCV13-type IPD incidence decreased 82% (from 15.3 to 2.7 cases/100,000) in that same time period.

The greatest decrease (80%) occurred in children under age 12 months. Decreases were 68% and 62.1% in those aged 12-35 months and 36-59 months, respectively, Ms. Farnham noted.

Another study presented at the meeting showed that 89% of PCV13 serotype disease in Ontario during the second year after the implementation of PCV13 vaccine (2012-2013) occurred in unvaccinated children. Half of the cases (14 of 28) were in children who were not eligible for vaccination, and of the remaining 14, 1 child was unvaccinated, 3 had missed doses, 7 had appropriately received PCV7 vaccine but missed the PCV13 catch-up dose, and 2 received PCV13 vaccine at ages 2 and 4 months but developed IPD at ages 10 and 11 months, respectively, Karen Green, an epidemiologist at Mount Sinai Hospital, Toronto, also reported in a poster.

One apparently healthy 5-year-old developed empyema from serotype 5 disease after receiving age-appropriate vaccination, she noted at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

The findings suggest that PCV13 vaccination is having a substantial effect on rates of IPD – an effect that could be improved upon with increased vaccine coverage.

A third study suggested that children over age 2 years, in particular, may not be vaccinated appropriately.

In that study, John M. McLaughlin, Ph.D., of Pfizer Specialty Care Medicines Development Group, Collegeville, Penn, showed that although children up to age 1 year had significant reductions in all 13 serotypes covered by the PCV13 vaccine, those aged 2-17 years did not experience a reduction in serotype 19A disease.

Overall, among children aged 0-17 years, the proportion of IPD caused by serotype 19A decreased from 37% in 2008-2009 to 28% in 2010-2011, and the proportion caused by the other 12 serotypes in the PCV13 vaccine decreased from 66% to 48% during the same period.

However, while there was a 44% relative reduction in the proportion of IPD caused by serotypes in the PCV13 vaccine among those aged 0-1 years, there was only a 17% relative reduction in those aged 2-17 years.

"The difference in these two age groups was driven largely by the difference in reduction of the proportion of IPD caused by serotype 19A," he said, explaining that there was a 36% relative reduction in the proportion of IPD caused by serotype 19A among those aged 0-1 years, but no decrease in those aged 2-17 years.

No difference was seen between the 0- to 1-year age group and the 2- to 17-year age group for the remaining serotypes (32% for both groups).

This could be a result of a lack of early indirect effect of vaccination or of the virulence of 19A, or it could be caused by more comorbid disease in the older age group. Comorbidities increased significantly with increasing age, Dr. McLaughlin said, noting that 27% of those aged less than 1 year had comorbid conditions, compared with 32% of those aged 1-2 years, 45% of those aged 3-5 years, and 60% of those aged 6-17 years.

Low PCV13 vaccination rates in older children may also be a factor; in this study, only two children aged 11 years and over had received PCV13 vaccination.

IPD cases in Dr. McLaughlin’s study were identified from eight geographically dispersed children’s hospitals in the U.S. Pediatric Multicenter Pneumococcal Surveillance Study Group. The findings support the Jan. 25, 2013, decision by the Food and Drug Administration to expand the age indication for PCV13 vaccination in children and teens to those aged 6-17 years for prevention of vaccine-type IPD, he concluded (AAP News 2013 March 6 [doi: 10.1542/aapnews.20130306-2]).

 

 

Ms. Farnham stressed the importance of vaccination.

"Given the potential of PCV13 to reduce IPD incidence and racial/ethnic disparities, efforts should be focused on increasing coverage of PCV13 and ensuring patients receive all the recommended doses of PCV13," she concluded.

Ms. Green reported working as a grant investigator for, and receiving educational and/or research support from, Pfizer and GlaxoSmithKline. Dr. McLaughlin reported that he is an employee and shareholder of Pfizer. Ms. Farnham reported having no disclosures.

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SAN FRANCISCO – The incidence of invasive pneumococcal disease among children is declining in the wake of the 2010 introduction of the 13-valent pneumococcal conjugate vaccine, surveillance data suggest.

In New York City during 2011-2012, for example, the incidence of invasive pneumococcal disease (IPD) declined among children under age 5 across all age categories and race/ethnicity groups, Andrea Farnham of the New York City Department of Health and Mental Hygiene reported in a poster at an annual scientific meeting on infectious diseases.

The decline was driven by a reduction in 13-valent pneumococcal conjugate vaccine (PCV13)-type IPD and was temporally associated with the introduction and increased uptake of PCV13 vaccine, she said.

IPD incidence decreased by 70% (from 21.0 to 6.4 cases/100,000) between 2007-2009 and 2011-2012, and PCV13-type IPD incidence decreased 82% (from 15.3 to 2.7 cases/100,000) in that same time period.

The greatest decrease (80%) occurred in children under age 12 months. Decreases were 68% and 62.1% in those aged 12-35 months and 36-59 months, respectively, Ms. Farnham noted.

Another study presented at the meeting showed that 89% of PCV13 serotype disease in Ontario during the second year after the implementation of PCV13 vaccine (2012-2013) occurred in unvaccinated children. Half of the cases (14 of 28) were in children who were not eligible for vaccination, and of the remaining 14, 1 child was unvaccinated, 3 had missed doses, 7 had appropriately received PCV7 vaccine but missed the PCV13 catch-up dose, and 2 received PCV13 vaccine at ages 2 and 4 months but developed IPD at ages 10 and 11 months, respectively, Karen Green, an epidemiologist at Mount Sinai Hospital, Toronto, also reported in a poster.

One apparently healthy 5-year-old developed empyema from serotype 5 disease after receiving age-appropriate vaccination, she noted at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

The findings suggest that PCV13 vaccination is having a substantial effect on rates of IPD – an effect that could be improved upon with increased vaccine coverage.

A third study suggested that children over age 2 years, in particular, may not be vaccinated appropriately.

In that study, John M. McLaughlin, Ph.D., of Pfizer Specialty Care Medicines Development Group, Collegeville, Penn, showed that although children up to age 1 year had significant reductions in all 13 serotypes covered by the PCV13 vaccine, those aged 2-17 years did not experience a reduction in serotype 19A disease.

Overall, among children aged 0-17 years, the proportion of IPD caused by serotype 19A decreased from 37% in 2008-2009 to 28% in 2010-2011, and the proportion caused by the other 12 serotypes in the PCV13 vaccine decreased from 66% to 48% during the same period.

However, while there was a 44% relative reduction in the proportion of IPD caused by serotypes in the PCV13 vaccine among those aged 0-1 years, there was only a 17% relative reduction in those aged 2-17 years.

"The difference in these two age groups was driven largely by the difference in reduction of the proportion of IPD caused by serotype 19A," he said, explaining that there was a 36% relative reduction in the proportion of IPD caused by serotype 19A among those aged 0-1 years, but no decrease in those aged 2-17 years.

No difference was seen between the 0- to 1-year age group and the 2- to 17-year age group for the remaining serotypes (32% for both groups).

This could be a result of a lack of early indirect effect of vaccination or of the virulence of 19A, or it could be caused by more comorbid disease in the older age group. Comorbidities increased significantly with increasing age, Dr. McLaughlin said, noting that 27% of those aged less than 1 year had comorbid conditions, compared with 32% of those aged 1-2 years, 45% of those aged 3-5 years, and 60% of those aged 6-17 years.

Low PCV13 vaccination rates in older children may also be a factor; in this study, only two children aged 11 years and over had received PCV13 vaccination.

IPD cases in Dr. McLaughlin’s study were identified from eight geographically dispersed children’s hospitals in the U.S. Pediatric Multicenter Pneumococcal Surveillance Study Group. The findings support the Jan. 25, 2013, decision by the Food and Drug Administration to expand the age indication for PCV13 vaccination in children and teens to those aged 6-17 years for prevention of vaccine-type IPD, he concluded (AAP News 2013 March 6 [doi: 10.1542/aapnews.20130306-2]).

 

 

Ms. Farnham stressed the importance of vaccination.

"Given the potential of PCV13 to reduce IPD incidence and racial/ethnic disparities, efforts should be focused on increasing coverage of PCV13 and ensuring patients receive all the recommended doses of PCV13," she concluded.

Ms. Green reported working as a grant investigator for, and receiving educational and/or research support from, Pfizer and GlaxoSmithKline. Dr. McLaughlin reported that he is an employee and shareholder of Pfizer. Ms. Farnham reported having no disclosures.

SAN FRANCISCO – The incidence of invasive pneumococcal disease among children is declining in the wake of the 2010 introduction of the 13-valent pneumococcal conjugate vaccine, surveillance data suggest.

In New York City during 2011-2012, for example, the incidence of invasive pneumococcal disease (IPD) declined among children under age 5 across all age categories and race/ethnicity groups, Andrea Farnham of the New York City Department of Health and Mental Hygiene reported in a poster at an annual scientific meeting on infectious diseases.

The decline was driven by a reduction in 13-valent pneumococcal conjugate vaccine (PCV13)-type IPD and was temporally associated with the introduction and increased uptake of PCV13 vaccine, she said.

IPD incidence decreased by 70% (from 21.0 to 6.4 cases/100,000) between 2007-2009 and 2011-2012, and PCV13-type IPD incidence decreased 82% (from 15.3 to 2.7 cases/100,000) in that same time period.

The greatest decrease (80%) occurred in children under age 12 months. Decreases were 68% and 62.1% in those aged 12-35 months and 36-59 months, respectively, Ms. Farnham noted.

Another study presented at the meeting showed that 89% of PCV13 serotype disease in Ontario during the second year after the implementation of PCV13 vaccine (2012-2013) occurred in unvaccinated children. Half of the cases (14 of 28) were in children who were not eligible for vaccination, and of the remaining 14, 1 child was unvaccinated, 3 had missed doses, 7 had appropriately received PCV7 vaccine but missed the PCV13 catch-up dose, and 2 received PCV13 vaccine at ages 2 and 4 months but developed IPD at ages 10 and 11 months, respectively, Karen Green, an epidemiologist at Mount Sinai Hospital, Toronto, also reported in a poster.

One apparently healthy 5-year-old developed empyema from serotype 5 disease after receiving age-appropriate vaccination, she noted at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

The findings suggest that PCV13 vaccination is having a substantial effect on rates of IPD – an effect that could be improved upon with increased vaccine coverage.

A third study suggested that children over age 2 years, in particular, may not be vaccinated appropriately.

In that study, John M. McLaughlin, Ph.D., of Pfizer Specialty Care Medicines Development Group, Collegeville, Penn, showed that although children up to age 1 year had significant reductions in all 13 serotypes covered by the PCV13 vaccine, those aged 2-17 years did not experience a reduction in serotype 19A disease.

Overall, among children aged 0-17 years, the proportion of IPD caused by serotype 19A decreased from 37% in 2008-2009 to 28% in 2010-2011, and the proportion caused by the other 12 serotypes in the PCV13 vaccine decreased from 66% to 48% during the same period.

However, while there was a 44% relative reduction in the proportion of IPD caused by serotypes in the PCV13 vaccine among those aged 0-1 years, there was only a 17% relative reduction in those aged 2-17 years.

"The difference in these two age groups was driven largely by the difference in reduction of the proportion of IPD caused by serotype 19A," he said, explaining that there was a 36% relative reduction in the proportion of IPD caused by serotype 19A among those aged 0-1 years, but no decrease in those aged 2-17 years.

No difference was seen between the 0- to 1-year age group and the 2- to 17-year age group for the remaining serotypes (32% for both groups).

This could be a result of a lack of early indirect effect of vaccination or of the virulence of 19A, or it could be caused by more comorbid disease in the older age group. Comorbidities increased significantly with increasing age, Dr. McLaughlin said, noting that 27% of those aged less than 1 year had comorbid conditions, compared with 32% of those aged 1-2 years, 45% of those aged 3-5 years, and 60% of those aged 6-17 years.

Low PCV13 vaccination rates in older children may also be a factor; in this study, only two children aged 11 years and over had received PCV13 vaccination.

IPD cases in Dr. McLaughlin’s study were identified from eight geographically dispersed children’s hospitals in the U.S. Pediatric Multicenter Pneumococcal Surveillance Study Group. The findings support the Jan. 25, 2013, decision by the Food and Drug Administration to expand the age indication for PCV13 vaccination in children and teens to those aged 6-17 years for prevention of vaccine-type IPD, he concluded (AAP News 2013 March 6 [doi: 10.1542/aapnews.20130306-2]).

 

 

Ms. Farnham stressed the importance of vaccination.

"Given the potential of PCV13 to reduce IPD incidence and racial/ethnic disparities, efforts should be focused on increasing coverage of PCV13 and ensuring patients receive all the recommended doses of PCV13," she concluded.

Ms. Green reported working as a grant investigator for, and receiving educational and/or research support from, Pfizer and GlaxoSmithKline. Dr. McLaughlin reported that he is an employee and shareholder of Pfizer. Ms. Farnham reported having no disclosures.

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Age-based differences seen in effects of PCV13
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Major finding: IPD cases declined following introduction of PCV13.

Data source: Medical chart review and surveillance.

Disclosures: Ms. Green reported working as a grant investigator for, and receiving educational and/or research support from, Pfizer and GlaxoSmithKline. Dr. McLaughlin reported that he is an employee and shareholder of Pfizer. Ms. Farnham reported having no disclosures.

Bicycle helmet use remains low, varies by ethnicity and socioeconomic status

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Bicycle helmet use remains low, varies by ethnicity and socioeconomic status

ORLANDO – Only 11.3% of more than 1,200 children involved in bicycle-related accidents were wearing a helmet at the time of the accident, a study showed.

Children over age 12, and those of minority background and lower socioeconomic status, had the lowest rates of helmet use; thus the findings have implications for targeted education and prevention strategies, Dr. Veronica Sullins reported at the annual meeting of the American Academy of Pediatrics.

©shironosov/iStockphoto.com
Only 11.3% of more than 1,200 children involved in bicycle-related accidents were wearing a helmet at the time of the accident, a study showed.      

Of the 1,248 children from Los Angeles County who were included in the retrospective study of all injuries related to pediatric bicycle accidents between 2006 and 2011, most (85%) were boys. More than a third (35.2%) of white children wore helmets, but the rates were much lower for Asian (7.0%), black (6.0%), and Hispanic children (4.2%), said Dr. Sullins of the Harbor-UCLA Medical Center in Torrance, Calif.

This is despite laws mandating helmet use in Los Angeles County, Dr. Sullins noted.

The differences in helmet use also appeared to vary based on socioeconomic status; helmets were worn by 15.2% of those with private insurance, compared with 7.6% of those with public insurance, Dr. Sullins noted.

Children in the study had a median age of 13 years. Those over age 12 were less likely to wear helmets than were those aged 12 years or younger (odds ratio, 0.7).

Emergency surgery was required in 5.9% of the children, and only 34.1% returned to their preinjury status. Nine patients (0.7%) died as a result of their injuries; eight of those were not wearing a helmet.

The findings suggest that targeting low-income middle and high schools and minority communities with bicycle safety education and accident prevention strategies may help improve helmet use in children, Dr. Sullins said.

"We really need to focus our efforts and resources on education programs targeting the highest-risk groups. In Los Angeles County, these groups are middle and high school–aged children, minorities, and those of lower socioeconomic status," Dr. Sullins said in an interview.

According to the Centers for Disease Control and Prevention, an estimated 33 million children ride bicycles – for a total of 10 billion hours - each year, and nearly 400 children die as a result of bicycle crashes.

More than 150,000 emergency department visits each year are due to bicycle-related head injuries.

Helmet use has been shown to reduce bicycle-related head injuries by 80%; yet, as the results of this study and others show, the rate of helmet use remains low. The CDC reports that only 15% of adults and 19% of children wear helmets most or all of the time when riding a bicycle.

"We encourage other investigators to perform similar studies to identify [the highest-risk] groups specific to their regions or cities in order to more efficiently direct local injury prevention programs," Dr. Sullins said in the interview.

She reported having no relevant financial disclosures.

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ORLANDO – Only 11.3% of more than 1,200 children involved in bicycle-related accidents were wearing a helmet at the time of the accident, a study showed.

Children over age 12, and those of minority background and lower socioeconomic status, had the lowest rates of helmet use; thus the findings have implications for targeted education and prevention strategies, Dr. Veronica Sullins reported at the annual meeting of the American Academy of Pediatrics.

©shironosov/iStockphoto.com
Only 11.3% of more than 1,200 children involved in bicycle-related accidents were wearing a helmet at the time of the accident, a study showed.      

Of the 1,248 children from Los Angeles County who were included in the retrospective study of all injuries related to pediatric bicycle accidents between 2006 and 2011, most (85%) were boys. More than a third (35.2%) of white children wore helmets, but the rates were much lower for Asian (7.0%), black (6.0%), and Hispanic children (4.2%), said Dr. Sullins of the Harbor-UCLA Medical Center in Torrance, Calif.

This is despite laws mandating helmet use in Los Angeles County, Dr. Sullins noted.

The differences in helmet use also appeared to vary based on socioeconomic status; helmets were worn by 15.2% of those with private insurance, compared with 7.6% of those with public insurance, Dr. Sullins noted.

Children in the study had a median age of 13 years. Those over age 12 were less likely to wear helmets than were those aged 12 years or younger (odds ratio, 0.7).

Emergency surgery was required in 5.9% of the children, and only 34.1% returned to their preinjury status. Nine patients (0.7%) died as a result of their injuries; eight of those were not wearing a helmet.

The findings suggest that targeting low-income middle and high schools and minority communities with bicycle safety education and accident prevention strategies may help improve helmet use in children, Dr. Sullins said.

"We really need to focus our efforts and resources on education programs targeting the highest-risk groups. In Los Angeles County, these groups are middle and high school–aged children, minorities, and those of lower socioeconomic status," Dr. Sullins said in an interview.

According to the Centers for Disease Control and Prevention, an estimated 33 million children ride bicycles – for a total of 10 billion hours - each year, and nearly 400 children die as a result of bicycle crashes.

More than 150,000 emergency department visits each year are due to bicycle-related head injuries.

Helmet use has been shown to reduce bicycle-related head injuries by 80%; yet, as the results of this study and others show, the rate of helmet use remains low. The CDC reports that only 15% of adults and 19% of children wear helmets most or all of the time when riding a bicycle.

"We encourage other investigators to perform similar studies to identify [the highest-risk] groups specific to their regions or cities in order to more efficiently direct local injury prevention programs," Dr. Sullins said in the interview.

She reported having no relevant financial disclosures.

ORLANDO – Only 11.3% of more than 1,200 children involved in bicycle-related accidents were wearing a helmet at the time of the accident, a study showed.

Children over age 12, and those of minority background and lower socioeconomic status, had the lowest rates of helmet use; thus the findings have implications for targeted education and prevention strategies, Dr. Veronica Sullins reported at the annual meeting of the American Academy of Pediatrics.

©shironosov/iStockphoto.com
Only 11.3% of more than 1,200 children involved in bicycle-related accidents were wearing a helmet at the time of the accident, a study showed.      

Of the 1,248 children from Los Angeles County who were included in the retrospective study of all injuries related to pediatric bicycle accidents between 2006 and 2011, most (85%) were boys. More than a third (35.2%) of white children wore helmets, but the rates were much lower for Asian (7.0%), black (6.0%), and Hispanic children (4.2%), said Dr. Sullins of the Harbor-UCLA Medical Center in Torrance, Calif.

This is despite laws mandating helmet use in Los Angeles County, Dr. Sullins noted.

The differences in helmet use also appeared to vary based on socioeconomic status; helmets were worn by 15.2% of those with private insurance, compared with 7.6% of those with public insurance, Dr. Sullins noted.

Children in the study had a median age of 13 years. Those over age 12 were less likely to wear helmets than were those aged 12 years or younger (odds ratio, 0.7).

Emergency surgery was required in 5.9% of the children, and only 34.1% returned to their preinjury status. Nine patients (0.7%) died as a result of their injuries; eight of those were not wearing a helmet.

The findings suggest that targeting low-income middle and high schools and minority communities with bicycle safety education and accident prevention strategies may help improve helmet use in children, Dr. Sullins said.

"We really need to focus our efforts and resources on education programs targeting the highest-risk groups. In Los Angeles County, these groups are middle and high school–aged children, minorities, and those of lower socioeconomic status," Dr. Sullins said in an interview.

According to the Centers for Disease Control and Prevention, an estimated 33 million children ride bicycles – for a total of 10 billion hours - each year, and nearly 400 children die as a result of bicycle crashes.

More than 150,000 emergency department visits each year are due to bicycle-related head injuries.

Helmet use has been shown to reduce bicycle-related head injuries by 80%; yet, as the results of this study and others show, the rate of helmet use remains low. The CDC reports that only 15% of adults and 19% of children wear helmets most or all of the time when riding a bicycle.

"We encourage other investigators to perform similar studies to identify [the highest-risk] groups specific to their regions or cities in order to more efficiently direct local injury prevention programs," Dr. Sullins said in the interview.

She reported having no relevant financial disclosures.

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Major finding: Only 11.3% of children injured in bicycle accidents were wearing a helmet (35.2%, 7.0%, 6.0%, and 4.2% of white, Asian, black, and Hispanic children, respectively).

Data source: A retrospective study of 1,248 cases of injury related to bicycle accidents during 2006-2011.

Disclosure: Dr. Sullins reported having no relevant financial disclosures.