M. Alexander Otto began his reporting career early in 1999 covering the pharmaceutical industry for a national pharmacists' magazine and freelancing for the Washington Post and other newspapers. He then joined BNA, now part of Bloomberg News, covering health law and the protection of people and animals in medical research. Alex next worked for the McClatchy Company. Based on his work, Alex won a year-long Knight Science Journalism Fellowship to MIT in 2008-2009. He joined the company shortly thereafter. Alex has a newspaper journalism degree from Syracuse (N.Y.) University and a master's degree in medical science -- a physician assistant degree -- from George Washington University. Alex is based in Seattle.

Gut flora emerging as key pediatric health component

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PORTLAND, ORE. – Fecal transplants are proving useful for pediatric ulcerative colitis, and enteral feedings are already well established in Europe to help kids with Crohn’s disease; together, the findings suggest that gut flora is more important to pediatric gastrointestinal health than previously thought, according to Dr. Linda Muir.

In both cases, "they think a lot of [the effect] has to do with modification of bowel flora. I think we are all starting to realize that the bacteria we carry around in our bodies drive and determine a lot of our health and illness. A lot of autoimmune disorders may be related to [imbalances in our] gut microbiome," said Dr. Muir, chief of pediatric gastroenterology at the Oregon Health and Science University in Portland.

Dr. Linda Muir

Although it’s unclear at the moment if donor stool is best delivered by nasogastric tube, colonoscope, or enema, it’s easy to understand how fecal transplants might correct such an imbalance. They’ve proven remarkably effective for Clostridium difficile infections, and now "good studies are being published for [their] application in [inflammatory bowel disease]. They’re very promising" for pediatric ulcerative colitis (UC), she said at a conference sponsored by the North Pacific Pediatric Society.

In one study from Michigan State and Emory universities, 10 children (aged 7-21 years) with mild to moderate UC received fecal enemas, 165 mL on average, for 5 days. Seven of nine (78%) – the 10th couldn’t retain the enema – showed a significant clinical response within a week, including three remissions. Six (67%) maintained their response at 1 month. There were no serious adverse events (J. Pediatr. Gastroenterol. Nutr. 2013;56:597-601).

If other studies have results like that, "I think [fecal transplants] may become more common in our practice. [Perhaps] we can turn around kids who are not responding to medication," Dr. Muir said.

It’s less clear how enteral feedings might rebalance the gut flora in Crohn’s kids. Typically, a child gets 100% of his or her nutrition for a period of time from milk-based products such as Ensure, Boost, or Nutren delivered by nasogastric tube at home; older children often learn to place the tube themselves. Dr. Muir favors products that pack the most calories in the least volume so kids don’t have to get up in the middle of the night to urinate; she uses enteral therapy as a supplement to the more usual Crohn’s approaches.

"Why does this make them better? We don’t know. Is it because of the nutrients? Are you removing food protein antigens? It may tie together with what we are seeing with fecal transplant, somehow modifying the fecal flora to allow mucosal healing. [Kids] obviously have much improved growth and they actually get true mucosal healing" on enteral feeding, unlike with steroids, Dr. Muir said.

Whatever the reason, pediatric gastroenterologists in Europe have been using the technique for years and touting its benefits. "They don’t use nearly the steroids U.S. physicians use," she said. In 2012, the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition noted that enteral feeding offers "an alternative to corticosteroids to induce remission in pediatric CD [Crohn’s disease] and should be supported as a first-line induction therapy in pediatric CD" (J. Pediatr. Gastroenterol. Nutr. 2012;54:298-305). And it just might be the case that CD kids don’t need to get all their calories through a tube. Researchers at the Children’s Hospital of Philadelphia recently reviewed the charts of 23 kids who got 80%-90% of their calories by enteral feedings and found that 20 (87%) had a clinical response, and 15 (65%) went into remission after a mean of 2 months (Inflamm. Bowel Dis. 2013;19:1374-8).

Even though they were on the tube at home, they could pull it out in the morning and have lunch with their friends at school just like any other kid, Dr. Muir said.

She said she had no relevant financial disclosures.

[email protected]

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PORTLAND, ORE. – Fecal transplants are proving useful for pediatric ulcerative colitis, and enteral feedings are already well established in Europe to help kids with Crohn’s disease; together, the findings suggest that gut flora is more important to pediatric gastrointestinal health than previously thought, according to Dr. Linda Muir.

In both cases, "they think a lot of [the effect] has to do with modification of bowel flora. I think we are all starting to realize that the bacteria we carry around in our bodies drive and determine a lot of our health and illness. A lot of autoimmune disorders may be related to [imbalances in our] gut microbiome," said Dr. Muir, chief of pediatric gastroenterology at the Oregon Health and Science University in Portland.

Dr. Linda Muir

Although it’s unclear at the moment if donor stool is best delivered by nasogastric tube, colonoscope, or enema, it’s easy to understand how fecal transplants might correct such an imbalance. They’ve proven remarkably effective for Clostridium difficile infections, and now "good studies are being published for [their] application in [inflammatory bowel disease]. They’re very promising" for pediatric ulcerative colitis (UC), she said at a conference sponsored by the North Pacific Pediatric Society.

In one study from Michigan State and Emory universities, 10 children (aged 7-21 years) with mild to moderate UC received fecal enemas, 165 mL on average, for 5 days. Seven of nine (78%) – the 10th couldn’t retain the enema – showed a significant clinical response within a week, including three remissions. Six (67%) maintained their response at 1 month. There were no serious adverse events (J. Pediatr. Gastroenterol. Nutr. 2013;56:597-601).

If other studies have results like that, "I think [fecal transplants] may become more common in our practice. [Perhaps] we can turn around kids who are not responding to medication," Dr. Muir said.

It’s less clear how enteral feedings might rebalance the gut flora in Crohn’s kids. Typically, a child gets 100% of his or her nutrition for a period of time from milk-based products such as Ensure, Boost, or Nutren delivered by nasogastric tube at home; older children often learn to place the tube themselves. Dr. Muir favors products that pack the most calories in the least volume so kids don’t have to get up in the middle of the night to urinate; she uses enteral therapy as a supplement to the more usual Crohn’s approaches.

"Why does this make them better? We don’t know. Is it because of the nutrients? Are you removing food protein antigens? It may tie together with what we are seeing with fecal transplant, somehow modifying the fecal flora to allow mucosal healing. [Kids] obviously have much improved growth and they actually get true mucosal healing" on enteral feeding, unlike with steroids, Dr. Muir said.

Whatever the reason, pediatric gastroenterologists in Europe have been using the technique for years and touting its benefits. "They don’t use nearly the steroids U.S. physicians use," she said. In 2012, the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition noted that enteral feeding offers "an alternative to corticosteroids to induce remission in pediatric CD [Crohn’s disease] and should be supported as a first-line induction therapy in pediatric CD" (J. Pediatr. Gastroenterol. Nutr. 2012;54:298-305). And it just might be the case that CD kids don’t need to get all their calories through a tube. Researchers at the Children’s Hospital of Philadelphia recently reviewed the charts of 23 kids who got 80%-90% of their calories by enteral feedings and found that 20 (87%) had a clinical response, and 15 (65%) went into remission after a mean of 2 months (Inflamm. Bowel Dis. 2013;19:1374-8).

Even though they were on the tube at home, they could pull it out in the morning and have lunch with their friends at school just like any other kid, Dr. Muir said.

She said she had no relevant financial disclosures.

[email protected]

PORTLAND, ORE. – Fecal transplants are proving useful for pediatric ulcerative colitis, and enteral feedings are already well established in Europe to help kids with Crohn’s disease; together, the findings suggest that gut flora is more important to pediatric gastrointestinal health than previously thought, according to Dr. Linda Muir.

In both cases, "they think a lot of [the effect] has to do with modification of bowel flora. I think we are all starting to realize that the bacteria we carry around in our bodies drive and determine a lot of our health and illness. A lot of autoimmune disorders may be related to [imbalances in our] gut microbiome," said Dr. Muir, chief of pediatric gastroenterology at the Oregon Health and Science University in Portland.

Dr. Linda Muir

Although it’s unclear at the moment if donor stool is best delivered by nasogastric tube, colonoscope, or enema, it’s easy to understand how fecal transplants might correct such an imbalance. They’ve proven remarkably effective for Clostridium difficile infections, and now "good studies are being published for [their] application in [inflammatory bowel disease]. They’re very promising" for pediatric ulcerative colitis (UC), she said at a conference sponsored by the North Pacific Pediatric Society.

In one study from Michigan State and Emory universities, 10 children (aged 7-21 years) with mild to moderate UC received fecal enemas, 165 mL on average, for 5 days. Seven of nine (78%) – the 10th couldn’t retain the enema – showed a significant clinical response within a week, including three remissions. Six (67%) maintained their response at 1 month. There were no serious adverse events (J. Pediatr. Gastroenterol. Nutr. 2013;56:597-601).

If other studies have results like that, "I think [fecal transplants] may become more common in our practice. [Perhaps] we can turn around kids who are not responding to medication," Dr. Muir said.

It’s less clear how enteral feedings might rebalance the gut flora in Crohn’s kids. Typically, a child gets 100% of his or her nutrition for a period of time from milk-based products such as Ensure, Boost, or Nutren delivered by nasogastric tube at home; older children often learn to place the tube themselves. Dr. Muir favors products that pack the most calories in the least volume so kids don’t have to get up in the middle of the night to urinate; she uses enteral therapy as a supplement to the more usual Crohn’s approaches.

"Why does this make them better? We don’t know. Is it because of the nutrients? Are you removing food protein antigens? It may tie together with what we are seeing with fecal transplant, somehow modifying the fecal flora to allow mucosal healing. [Kids] obviously have much improved growth and they actually get true mucosal healing" on enteral feeding, unlike with steroids, Dr. Muir said.

Whatever the reason, pediatric gastroenterologists in Europe have been using the technique for years and touting its benefits. "They don’t use nearly the steroids U.S. physicians use," she said. In 2012, the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition noted that enteral feeding offers "an alternative to corticosteroids to induce remission in pediatric CD [Crohn’s disease] and should be supported as a first-line induction therapy in pediatric CD" (J. Pediatr. Gastroenterol. Nutr. 2012;54:298-305). And it just might be the case that CD kids don’t need to get all their calories through a tube. Researchers at the Children’s Hospital of Philadelphia recently reviewed the charts of 23 kids who got 80%-90% of their calories by enteral feedings and found that 20 (87%) had a clinical response, and 15 (65%) went into remission after a mean of 2 months (Inflamm. Bowel Dis. 2013;19:1374-8).

Even though they were on the tube at home, they could pull it out in the morning and have lunch with their friends at school just like any other kid, Dr. Muir said.

She said she had no relevant financial disclosures.

[email protected]

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Vancomycin, properly dosed, is as safe on the kidneys as linezolid

Consider multiple factors in treatment of gram-positive infections
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Vancomycin, properly dosed, is as safe on the kidneys as linezolid

LAS VEGAS – Vancomycin is as safe on the kidneys of critically ill patients as linezolid, so long as trough levels don’t exceed the recommended upper limit of 20 mcg/mL, according to researchers from the University of Virginia in Charlottesville.

"When correct dosing is performed, the use of alternative agents to treat Gram-positive infections – specifically to avoid [vancomycin] nephrotoxicity – is unnecessary. Vancomycin use in critically ill patients is no different than linezolid use regarding nephrotoxicity or new-onset need for hemodialysis," said lead investigator Stephen Davies, a resident in the department of surgery, said at the annual meeting of the Surgical Infection Society.

Dr. Stephen Davies

The kidney safety of vancomycin has been in doubt, with mixed results from prior studies. To shed light on the issue, Dr. Davies and his team compared renal outcomes in 298 critically ill patients treated with vancomycin for 571 Gram-positive infections with outcomes in 247 patients treated with linezolid for 475 Gram-positive infections.

Infection sites included the lungs, peritoneum, blood stream, and urinary tract, among others, and isolates included Staphylococcus aureus (77 methicillin-resistant S. aureus), Enterococcus faecium (67 vancomycin-resistant Enterococcus), E. faecalis, and Streptococcus species. Vancomycin patients were dosed at 15-20 mg/kg, with serial trough monitoring, and treated for a mean of 16.2 days, vs. 14.3 days for linezolid. Patients were on no other nephrotoxic agents.

In the end, "there were no [statistically significant] differences between the two groups regarding maximum creatinine during treatment, final creatinine after treatment, change in creatinine maximum and initial values, and final and initial creatinine values." There were also no differences "in new-onset hemodialysis or death," Dr. Davies said.

APACHE II (Acute Physiology and Chronic Health Evaluation II) scores above 30 and initial creatinine levels above 1.2 mg/dL both predicted the need for new-onset hemodialysis, but antibiotic choice did not.

Those same two variables also predicted an increase in creatinine of more than 1.0 mg/dl during treatment; vancomycin use did, as well (relative risk, vancomycin 0.49; 95% confidence interval: 0.25-0.94). Concerned, the team looked into the issue. "What we found was that a rise in creatinine was typically not encountered until trough levels greater than 20 mg/dL were reached. As long as you stay within the recommended doses, you should be safe," Dr. Davies said.

There were no statistically significant baseline differences between the two groups in renal function, hemodialysis, creatinine levels, or APACHE II scores.

Despite the results, Dr. Philip Barie, who helped moderate Dr. Davies’ talk, said in an interview that he’s still concerned about vancomycin kidney safety.

"We are having to use higher doses to treat tougher bugs, and whereas nephrotoxicity pretty much went away with vancomycin after they purified the drug [decades ago], now we are having to use higher doses more, and nephrotoxicity is beginning to creep back into the picture. You have to dose really carefully, and if you have an organism that is among the more resistant to vancomycin, the safest thing to do with vancomycin is to use linezolid," said Dr. Barie, a professor of surgery and public heath at Cornell University, New York.

Dr. Davies and Dr. Barie reported no relevant disclosures.

[email protected]

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Multiple factors must be considered in determining the optimal antibiotic treatment of gram-positive infections including but not limited to clinical and microbiological efficacy, development of resistant microorganisms, adverse effects, and costs. Several recent meta-analyses have reported conflicting results regarding whether linezolid is superior to vancomycin in clinical and/or microbiological efficacy, but all have reported increased nephrotoxicity with vancomycin (PLoS ONE 2013;8:e58240; Int. J. Antimicrob. Agents 2013;41:426-33; Eur. J. Clin. Microbiol. Infect. Dis. 2013).

However, none of these performed metaregression analyses to determine whether there is an association between vancomycin troughs and risk of nephrotoxicity. While the study by Dr. Davies et al. suggests such a relationship, there is inadequate data to determine if the higher vancomycin troughs, which were associated with creatinine elevations above 1.0 mg/dL, were necessary to eradicate the Gram-positive infections. Furthermore, despite the adjustment for severity of illness, there may have been a selection bias in the initial choice of antibiotics. Lastly, treatment selection for Gram-positive infections should also take into account: the costs and resources necessary to monitor vancomycin troughs, and the feasibility of performing timely and appropriate dose adjustments based on troughs to achieve a therapeutic yet nontoxic level.

Lillian S. Kao, MD, FACS, of the department of surgery, University of Texas Health Science Center at Houston.

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Multiple factors must be considered in determining the optimal antibiotic treatment of gram-positive infections including but not limited to clinical and microbiological efficacy, development of resistant microorganisms, adverse effects, and costs. Several recent meta-analyses have reported conflicting results regarding whether linezolid is superior to vancomycin in clinical and/or microbiological efficacy, but all have reported increased nephrotoxicity with vancomycin (PLoS ONE 2013;8:e58240; Int. J. Antimicrob. Agents 2013;41:426-33; Eur. J. Clin. Microbiol. Infect. Dis. 2013).

However, none of these performed metaregression analyses to determine whether there is an association between vancomycin troughs and risk of nephrotoxicity. While the study by Dr. Davies et al. suggests such a relationship, there is inadequate data to determine if the higher vancomycin troughs, which were associated with creatinine elevations above 1.0 mg/dL, were necessary to eradicate the Gram-positive infections. Furthermore, despite the adjustment for severity of illness, there may have been a selection bias in the initial choice of antibiotics. Lastly, treatment selection for Gram-positive infections should also take into account: the costs and resources necessary to monitor vancomycin troughs, and the feasibility of performing timely and appropriate dose adjustments based on troughs to achieve a therapeutic yet nontoxic level.

Lillian S. Kao, MD, FACS, of the department of surgery, University of Texas Health Science Center at Houston.

Body

Multiple factors must be considered in determining the optimal antibiotic treatment of gram-positive infections including but not limited to clinical and microbiological efficacy, development of resistant microorganisms, adverse effects, and costs. Several recent meta-analyses have reported conflicting results regarding whether linezolid is superior to vancomycin in clinical and/or microbiological efficacy, but all have reported increased nephrotoxicity with vancomycin (PLoS ONE 2013;8:e58240; Int. J. Antimicrob. Agents 2013;41:426-33; Eur. J. Clin. Microbiol. Infect. Dis. 2013).

However, none of these performed metaregression analyses to determine whether there is an association between vancomycin troughs and risk of nephrotoxicity. While the study by Dr. Davies et al. suggests such a relationship, there is inadequate data to determine if the higher vancomycin troughs, which were associated with creatinine elevations above 1.0 mg/dL, were necessary to eradicate the Gram-positive infections. Furthermore, despite the adjustment for severity of illness, there may have been a selection bias in the initial choice of antibiotics. Lastly, treatment selection for Gram-positive infections should also take into account: the costs and resources necessary to monitor vancomycin troughs, and the feasibility of performing timely and appropriate dose adjustments based on troughs to achieve a therapeutic yet nontoxic level.

Lillian S. Kao, MD, FACS, of the department of surgery, University of Texas Health Science Center at Houston.

Title
Consider multiple factors in treatment of gram-positive infections
Consider multiple factors in treatment of gram-positive infections

LAS VEGAS – Vancomycin is as safe on the kidneys of critically ill patients as linezolid, so long as trough levels don’t exceed the recommended upper limit of 20 mcg/mL, according to researchers from the University of Virginia in Charlottesville.

"When correct dosing is performed, the use of alternative agents to treat Gram-positive infections – specifically to avoid [vancomycin] nephrotoxicity – is unnecessary. Vancomycin use in critically ill patients is no different than linezolid use regarding nephrotoxicity or new-onset need for hemodialysis," said lead investigator Stephen Davies, a resident in the department of surgery, said at the annual meeting of the Surgical Infection Society.

Dr. Stephen Davies

The kidney safety of vancomycin has been in doubt, with mixed results from prior studies. To shed light on the issue, Dr. Davies and his team compared renal outcomes in 298 critically ill patients treated with vancomycin for 571 Gram-positive infections with outcomes in 247 patients treated with linezolid for 475 Gram-positive infections.

Infection sites included the lungs, peritoneum, blood stream, and urinary tract, among others, and isolates included Staphylococcus aureus (77 methicillin-resistant S. aureus), Enterococcus faecium (67 vancomycin-resistant Enterococcus), E. faecalis, and Streptococcus species. Vancomycin patients were dosed at 15-20 mg/kg, with serial trough monitoring, and treated for a mean of 16.2 days, vs. 14.3 days for linezolid. Patients were on no other nephrotoxic agents.

In the end, "there were no [statistically significant] differences between the two groups regarding maximum creatinine during treatment, final creatinine after treatment, change in creatinine maximum and initial values, and final and initial creatinine values." There were also no differences "in new-onset hemodialysis or death," Dr. Davies said.

APACHE II (Acute Physiology and Chronic Health Evaluation II) scores above 30 and initial creatinine levels above 1.2 mg/dL both predicted the need for new-onset hemodialysis, but antibiotic choice did not.

Those same two variables also predicted an increase in creatinine of more than 1.0 mg/dl during treatment; vancomycin use did, as well (relative risk, vancomycin 0.49; 95% confidence interval: 0.25-0.94). Concerned, the team looked into the issue. "What we found was that a rise in creatinine was typically not encountered until trough levels greater than 20 mg/dL were reached. As long as you stay within the recommended doses, you should be safe," Dr. Davies said.

There were no statistically significant baseline differences between the two groups in renal function, hemodialysis, creatinine levels, or APACHE II scores.

Despite the results, Dr. Philip Barie, who helped moderate Dr. Davies’ talk, said in an interview that he’s still concerned about vancomycin kidney safety.

"We are having to use higher doses to treat tougher bugs, and whereas nephrotoxicity pretty much went away with vancomycin after they purified the drug [decades ago], now we are having to use higher doses more, and nephrotoxicity is beginning to creep back into the picture. You have to dose really carefully, and if you have an organism that is among the more resistant to vancomycin, the safest thing to do with vancomycin is to use linezolid," said Dr. Barie, a professor of surgery and public heath at Cornell University, New York.

Dr. Davies and Dr. Barie reported no relevant disclosures.

[email protected]

LAS VEGAS – Vancomycin is as safe on the kidneys of critically ill patients as linezolid, so long as trough levels don’t exceed the recommended upper limit of 20 mcg/mL, according to researchers from the University of Virginia in Charlottesville.

"When correct dosing is performed, the use of alternative agents to treat Gram-positive infections – specifically to avoid [vancomycin] nephrotoxicity – is unnecessary. Vancomycin use in critically ill patients is no different than linezolid use regarding nephrotoxicity or new-onset need for hemodialysis," said lead investigator Stephen Davies, a resident in the department of surgery, said at the annual meeting of the Surgical Infection Society.

Dr. Stephen Davies

The kidney safety of vancomycin has been in doubt, with mixed results from prior studies. To shed light on the issue, Dr. Davies and his team compared renal outcomes in 298 critically ill patients treated with vancomycin for 571 Gram-positive infections with outcomes in 247 patients treated with linezolid for 475 Gram-positive infections.

Infection sites included the lungs, peritoneum, blood stream, and urinary tract, among others, and isolates included Staphylococcus aureus (77 methicillin-resistant S. aureus), Enterococcus faecium (67 vancomycin-resistant Enterococcus), E. faecalis, and Streptococcus species. Vancomycin patients were dosed at 15-20 mg/kg, with serial trough monitoring, and treated for a mean of 16.2 days, vs. 14.3 days for linezolid. Patients were on no other nephrotoxic agents.

In the end, "there were no [statistically significant] differences between the two groups regarding maximum creatinine during treatment, final creatinine after treatment, change in creatinine maximum and initial values, and final and initial creatinine values." There were also no differences "in new-onset hemodialysis or death," Dr. Davies said.

APACHE II (Acute Physiology and Chronic Health Evaluation II) scores above 30 and initial creatinine levels above 1.2 mg/dL both predicted the need for new-onset hemodialysis, but antibiotic choice did not.

Those same two variables also predicted an increase in creatinine of more than 1.0 mg/dl during treatment; vancomycin use did, as well (relative risk, vancomycin 0.49; 95% confidence interval: 0.25-0.94). Concerned, the team looked into the issue. "What we found was that a rise in creatinine was typically not encountered until trough levels greater than 20 mg/dL were reached. As long as you stay within the recommended doses, you should be safe," Dr. Davies said.

There were no statistically significant baseline differences between the two groups in renal function, hemodialysis, creatinine levels, or APACHE II scores.

Despite the results, Dr. Philip Barie, who helped moderate Dr. Davies’ talk, said in an interview that he’s still concerned about vancomycin kidney safety.

"We are having to use higher doses to treat tougher bugs, and whereas nephrotoxicity pretty much went away with vancomycin after they purified the drug [decades ago], now we are having to use higher doses more, and nephrotoxicity is beginning to creep back into the picture. You have to dose really carefully, and if you have an organism that is among the more resistant to vancomycin, the safest thing to do with vancomycin is to use linezolid," said Dr. Barie, a professor of surgery and public heath at Cornell University, New York.

Dr. Davies and Dr. Barie reported no relevant disclosures.

[email protected]

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Major finding: Vancomycin is as safe on the kidneys of critically ill patients as linezolid, so long as trough levels don’t exceed the recommended upper limit of 20 mcg/mL.

Data source: Single-center, retrospective cohort study in 545 critically ill patients

Disclosures: The lead investigator said he has no financial conflicts.

Hypoglycemia linked to increased morbidity risk in pediatric burn patients

Focus not only on treatment but on avoidance
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Hypoglycemia linked to increased morbidity risk in pediatric burn patients

LAS VEGAS – Although inpatient glucose levels in critically ill adults are generally kept between 140 and 180 mg/dL, Toronto investigators have found that it might be best to keep pediatric burn patients between 130 and 140 mg/dL.

Morbidity and mortality outcomes were better in that range when 760 children – the majority boys under 10 years old burned over half their bodies, usually by flame – were followed for 2 months after ICU admission.

"We used about 300,000 glucose measurements" during the study "to determine the ideal glucose target. For burn patients, the range of 130-140 mg/dL should be targeted. You avoid hyperglycemia as well as hypoglycemia. [Also,] a major factor to be considered" in burns "is that protein glycosylation starts at around 150 mg/dL; we burn surgeons try to be below that," said lead researcher Dr. Marc Jeschke, director of the burn center at Toronto’s Sunnybrook Health Sciences Centre.

Dr. Jeschke’s study isn’t the first to suggest that range for critically ill children. "There seems to be a signal [across] studies that this is the range we should target in order to see the benefits of glucose control," he said (e.g., J. Pediatr. 2009;155:734-9).

It’s been known that burns cause a hyperglycemic response, especially those in excess of 40% of the body. When not reined in, "you lose more grafts, you have more infections, and you [are more likely to] die," Dr. Jeschke said at the annual meeting of the Surgical Infection Society.

In its investigation, however, his team also found that, as in critically ill adults, hypoglycemia must also be avoided in pediatric burn patients.

Eighty-five patients had one hypoglycemia episode in the study, defined as blood glucose below 60?mg/dL, and 107 had two or more. The remaining 568 children had no episodes.

Twenty-one percent of patients who had hypoglycemic episodes – versus 6.5% of those who did not – developed sepsis; 47.9%, versus 10%, developed multiple organ failure, and a quarter died. Mortality was 3.3% in the nonhypoglycemic group. The differences were statistically significant.

"We [also] found that hypoglycemic patients are more inflammatory and hypermetabolic," Dr. Jeschke said.

Hypoglycemia was associated with larger burns and more inhalation injuries, so the team did a propensity analysis comparing 166 children who had hypoglycemic episodes to 166 with similar injury severities who did not.

Among those matched patients, children were 2.67 more likely to die (95% confidence interval 1.15-6.20) if they had one hypoglycemic episode, 5.58 more likely to die if they had two (95% CI 2.26-13.81), and 9.25 times more likely if they had three (95% CI 4.30-19.88).

Hypoglycemia during sepsis or at time of death was excluded in the analysis. Even so, "we don’t know" if hypoglycemia was the cause of death or a marker for another fatal process, Dr. Jeschke noted.

Whatever the case, the results indicate that just as in sick adults, "glycemic control in [pediatric] burns is an integral part of good clinical outcomes," he said.

Dr. Jeschke said he has no conflicts of interest.

[email protected]

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Glycemic control in critically ill patients, both children and adults, has been extensively studied in the past decade. Despite the evidence for harms associated with hyperglycemia such as increased risk of infection, the optimal glucose range for critically ill patients is a moving target. As noted in Dr. Jeschke's study, the risk of mortality in critically ill pediatric burn patients treated with an insulin protocol increased as the number of hypoglycemic episodes (below 60 mg/dL) increased.

Despite the initial rapid adoption of tight glycemic control in critically ill patients, the benefits have not always outweighed the harms. Thus, in implementing glycemic control regimens, attention needs to be focused not only on the treatment of hyperglycemia but also on the avoidance of hypoglycemia in order to ensure good patient outcomes.

Dr. Lillian S. Kao, FACS, is an associate professor of surgery, University of Texas Health Science Center at Houston

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Glycemic control in critically ill patients, both children and adults, has been extensively studied in the past decade. Despite the evidence for harms associated with hyperglycemia such as increased risk of infection, the optimal glucose range for critically ill patients is a moving target. As noted in Dr. Jeschke's study, the risk of mortality in critically ill pediatric burn patients treated with an insulin protocol increased as the number of hypoglycemic episodes (below 60 mg/dL) increased.

Despite the initial rapid adoption of tight glycemic control in critically ill patients, the benefits have not always outweighed the harms. Thus, in implementing glycemic control regimens, attention needs to be focused not only on the treatment of hyperglycemia but also on the avoidance of hypoglycemia in order to ensure good patient outcomes.

Dr. Lillian S. Kao, FACS, is an associate professor of surgery, University of Texas Health Science Center at Houston

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Glycemic control in critically ill patients, both children and adults, has been extensively studied in the past decade. Despite the evidence for harms associated with hyperglycemia such as increased risk of infection, the optimal glucose range for critically ill patients is a moving target. As noted in Dr. Jeschke's study, the risk of mortality in critically ill pediatric burn patients treated with an insulin protocol increased as the number of hypoglycemic episodes (below 60 mg/dL) increased.

Despite the initial rapid adoption of tight glycemic control in critically ill patients, the benefits have not always outweighed the harms. Thus, in implementing glycemic control regimens, attention needs to be focused not only on the treatment of hyperglycemia but also on the avoidance of hypoglycemia in order to ensure good patient outcomes.

Dr. Lillian S. Kao, FACS, is an associate professor of surgery, University of Texas Health Science Center at Houston

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Focus not only on treatment but on avoidance
Focus not only on treatment but on avoidance

LAS VEGAS – Although inpatient glucose levels in critically ill adults are generally kept between 140 and 180 mg/dL, Toronto investigators have found that it might be best to keep pediatric burn patients between 130 and 140 mg/dL.

Morbidity and mortality outcomes were better in that range when 760 children – the majority boys under 10 years old burned over half their bodies, usually by flame – were followed for 2 months after ICU admission.

"We used about 300,000 glucose measurements" during the study "to determine the ideal glucose target. For burn patients, the range of 130-140 mg/dL should be targeted. You avoid hyperglycemia as well as hypoglycemia. [Also,] a major factor to be considered" in burns "is that protein glycosylation starts at around 150 mg/dL; we burn surgeons try to be below that," said lead researcher Dr. Marc Jeschke, director of the burn center at Toronto’s Sunnybrook Health Sciences Centre.

Dr. Jeschke’s study isn’t the first to suggest that range for critically ill children. "There seems to be a signal [across] studies that this is the range we should target in order to see the benefits of glucose control," he said (e.g., J. Pediatr. 2009;155:734-9).

It’s been known that burns cause a hyperglycemic response, especially those in excess of 40% of the body. When not reined in, "you lose more grafts, you have more infections, and you [are more likely to] die," Dr. Jeschke said at the annual meeting of the Surgical Infection Society.

In its investigation, however, his team also found that, as in critically ill adults, hypoglycemia must also be avoided in pediatric burn patients.

Eighty-five patients had one hypoglycemia episode in the study, defined as blood glucose below 60?mg/dL, and 107 had two or more. The remaining 568 children had no episodes.

Twenty-one percent of patients who had hypoglycemic episodes – versus 6.5% of those who did not – developed sepsis; 47.9%, versus 10%, developed multiple organ failure, and a quarter died. Mortality was 3.3% in the nonhypoglycemic group. The differences were statistically significant.

"We [also] found that hypoglycemic patients are more inflammatory and hypermetabolic," Dr. Jeschke said.

Hypoglycemia was associated with larger burns and more inhalation injuries, so the team did a propensity analysis comparing 166 children who had hypoglycemic episodes to 166 with similar injury severities who did not.

Among those matched patients, children were 2.67 more likely to die (95% confidence interval 1.15-6.20) if they had one hypoglycemic episode, 5.58 more likely to die if they had two (95% CI 2.26-13.81), and 9.25 times more likely if they had three (95% CI 4.30-19.88).

Hypoglycemia during sepsis or at time of death was excluded in the analysis. Even so, "we don’t know" if hypoglycemia was the cause of death or a marker for another fatal process, Dr. Jeschke noted.

Whatever the case, the results indicate that just as in sick adults, "glycemic control in [pediatric] burns is an integral part of good clinical outcomes," he said.

Dr. Jeschke said he has no conflicts of interest.

[email protected]

LAS VEGAS – Although inpatient glucose levels in critically ill adults are generally kept between 140 and 180 mg/dL, Toronto investigators have found that it might be best to keep pediatric burn patients between 130 and 140 mg/dL.

Morbidity and mortality outcomes were better in that range when 760 children – the majority boys under 10 years old burned over half their bodies, usually by flame – were followed for 2 months after ICU admission.

"We used about 300,000 glucose measurements" during the study "to determine the ideal glucose target. For burn patients, the range of 130-140 mg/dL should be targeted. You avoid hyperglycemia as well as hypoglycemia. [Also,] a major factor to be considered" in burns "is that protein glycosylation starts at around 150 mg/dL; we burn surgeons try to be below that," said lead researcher Dr. Marc Jeschke, director of the burn center at Toronto’s Sunnybrook Health Sciences Centre.

Dr. Jeschke’s study isn’t the first to suggest that range for critically ill children. "There seems to be a signal [across] studies that this is the range we should target in order to see the benefits of glucose control," he said (e.g., J. Pediatr. 2009;155:734-9).

It’s been known that burns cause a hyperglycemic response, especially those in excess of 40% of the body. When not reined in, "you lose more grafts, you have more infections, and you [are more likely to] die," Dr. Jeschke said at the annual meeting of the Surgical Infection Society.

In its investigation, however, his team also found that, as in critically ill adults, hypoglycemia must also be avoided in pediatric burn patients.

Eighty-five patients had one hypoglycemia episode in the study, defined as blood glucose below 60?mg/dL, and 107 had two or more. The remaining 568 children had no episodes.

Twenty-one percent of patients who had hypoglycemic episodes – versus 6.5% of those who did not – developed sepsis; 47.9%, versus 10%, developed multiple organ failure, and a quarter died. Mortality was 3.3% in the nonhypoglycemic group. The differences were statistically significant.

"We [also] found that hypoglycemic patients are more inflammatory and hypermetabolic," Dr. Jeschke said.

Hypoglycemia was associated with larger burns and more inhalation injuries, so the team did a propensity analysis comparing 166 children who had hypoglycemic episodes to 166 with similar injury severities who did not.

Among those matched patients, children were 2.67 more likely to die (95% confidence interval 1.15-6.20) if they had one hypoglycemic episode, 5.58 more likely to die if they had two (95% CI 2.26-13.81), and 9.25 times more likely if they had three (95% CI 4.30-19.88).

Hypoglycemia during sepsis or at time of death was excluded in the analysis. Even so, "we don’t know" if hypoglycemia was the cause of death or a marker for another fatal process, Dr. Jeschke noted.

Whatever the case, the results indicate that just as in sick adults, "glycemic control in [pediatric] burns is an integral part of good clinical outcomes," he said.

Dr. Jeschke said he has no conflicts of interest.

[email protected]

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Major finding: Severely burned children are almost three times more likely to die if they have even one hypoglycemic episode.

Data Source: Retrospective review of 760 pediatric burn patients.

Disclosures: The lead investigator said he has no disclosures.

Swab both the nose and throat to catch Staph colonization

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LAS VEGAS – It’s a good idea to swab both the throat and nose when looking for Staphylococcus aureus colonization; doing so picks up cases missed by swabbing the nares alone, according to researchers from the Baylor College of Medicine in Houston.

That holds true whether testing is by culture or PCR [polymerase chain reaction], said the lead investigator, Dr. Meredith Knofsky, a surgery resident there.

The team swabbed both areas preoperatively and on the day of surgery in patients undergoing operations involving hardware implants, such as new knees or hips. The 109 samples they obtained were then tested for methicillin-sensitive (MSSA) and methicillin-resistant (MRSA) S. aureus by both MRSA select media culture and the GeneXpert PCR system.

By culture, 7 throat swabs and 18 nares swabs were positive for MRSA; 20 throat and 40 nares swabs were positive for MSSA.

Courtesy Janice Haney Carr/CDC
Magnified 20,000X, this colorized scanning electron micrograph (SEM) depicts a grouping of methicillin resistant Staphylococcus aureus (MRSA) bacteria. (Photo courtesy Janice Haney Carr/CDC)

By PCR, 7 throat and 21 nares samples were MRSA positive; 33 throat and 51 nares swabs were positive for MSSA.

The detection rate differences weren’t surprising; PCR is known to be more accurate and the results confirm its greater sensitivity, Dr. Knofsky said at the annual meeting of the Surgical Infection Society.

The bigger finding is that "throat screening identifies additional patients missed by screening the nares alone," she said.

Adding PCR throat testing to PCR nasal screening picked up one additional MRSA and 14 additional MSSA carriers. Similarly, the addition of throat cultures to nares cultures picked up an additional MRSA and eight additional MSSA carriers.

Not infrequently, patients were positive in one location, such as the throat, but not in the other. Although "nasal carrier status of Staphylococcus aureus is an important risk factor for surgical site infections," it’s not known at the moment if that’s also true for carriage limited to the throat, Dr. Knofsky said.

"We have plans to go back and evaluate which of these patients colonized only in the oropharynx actually developed a surgical site infection. It’s important that we invest in evaluating pharyngeal carriage," she said.

In the meantime, session moderator and surgeon Dr. E. Patchen Dellinger of the University of Washington in Seattle, noted that MSSA in the study "was two to three times more common than MRSA; an MSSA infection of implanted hardware is just as devastating to the patient as an MRSA infection. I would like to urge that we not focus on MRSA alone, but consider at least in selected surgical populations seeking and suppressing any Staph that colonizes our surgical patients."

PCR could help with that because it "has the advantage of very rapid answers. The logistics of getting [colonization] information in time to do something [before an operation] is very difficult for us. PCR could make that better, [but it] isn’t standard of care mostly because it costs a lot more" than does culture, he said.

Dr. Knofsky and Dr. Dellinger said they have no relevant disclosures.

[email protected]

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LAS VEGAS – It’s a good idea to swab both the throat and nose when looking for Staphylococcus aureus colonization; doing so picks up cases missed by swabbing the nares alone, according to researchers from the Baylor College of Medicine in Houston.

That holds true whether testing is by culture or PCR [polymerase chain reaction], said the lead investigator, Dr. Meredith Knofsky, a surgery resident there.

The team swabbed both areas preoperatively and on the day of surgery in patients undergoing operations involving hardware implants, such as new knees or hips. The 109 samples they obtained were then tested for methicillin-sensitive (MSSA) and methicillin-resistant (MRSA) S. aureus by both MRSA select media culture and the GeneXpert PCR system.

By culture, 7 throat swabs and 18 nares swabs were positive for MRSA; 20 throat and 40 nares swabs were positive for MSSA.

Courtesy Janice Haney Carr/CDC
Magnified 20,000X, this colorized scanning electron micrograph (SEM) depicts a grouping of methicillin resistant Staphylococcus aureus (MRSA) bacteria. (Photo courtesy Janice Haney Carr/CDC)

By PCR, 7 throat and 21 nares samples were MRSA positive; 33 throat and 51 nares swabs were positive for MSSA.

The detection rate differences weren’t surprising; PCR is known to be more accurate and the results confirm its greater sensitivity, Dr. Knofsky said at the annual meeting of the Surgical Infection Society.

The bigger finding is that "throat screening identifies additional patients missed by screening the nares alone," she said.

Adding PCR throat testing to PCR nasal screening picked up one additional MRSA and 14 additional MSSA carriers. Similarly, the addition of throat cultures to nares cultures picked up an additional MRSA and eight additional MSSA carriers.

Not infrequently, patients were positive in one location, such as the throat, but not in the other. Although "nasal carrier status of Staphylococcus aureus is an important risk factor for surgical site infections," it’s not known at the moment if that’s also true for carriage limited to the throat, Dr. Knofsky said.

"We have plans to go back and evaluate which of these patients colonized only in the oropharynx actually developed a surgical site infection. It’s important that we invest in evaluating pharyngeal carriage," she said.

In the meantime, session moderator and surgeon Dr. E. Patchen Dellinger of the University of Washington in Seattle, noted that MSSA in the study "was two to three times more common than MRSA; an MSSA infection of implanted hardware is just as devastating to the patient as an MRSA infection. I would like to urge that we not focus on MRSA alone, but consider at least in selected surgical populations seeking and suppressing any Staph that colonizes our surgical patients."

PCR could help with that because it "has the advantage of very rapid answers. The logistics of getting [colonization] information in time to do something [before an operation] is very difficult for us. PCR could make that better, [but it] isn’t standard of care mostly because it costs a lot more" than does culture, he said.

Dr. Knofsky and Dr. Dellinger said they have no relevant disclosures.

[email protected]

LAS VEGAS – It’s a good idea to swab both the throat and nose when looking for Staphylococcus aureus colonization; doing so picks up cases missed by swabbing the nares alone, according to researchers from the Baylor College of Medicine in Houston.

That holds true whether testing is by culture or PCR [polymerase chain reaction], said the lead investigator, Dr. Meredith Knofsky, a surgery resident there.

The team swabbed both areas preoperatively and on the day of surgery in patients undergoing operations involving hardware implants, such as new knees or hips. The 109 samples they obtained were then tested for methicillin-sensitive (MSSA) and methicillin-resistant (MRSA) S. aureus by both MRSA select media culture and the GeneXpert PCR system.

By culture, 7 throat swabs and 18 nares swabs were positive for MRSA; 20 throat and 40 nares swabs were positive for MSSA.

Courtesy Janice Haney Carr/CDC
Magnified 20,000X, this colorized scanning electron micrograph (SEM) depicts a grouping of methicillin resistant Staphylococcus aureus (MRSA) bacteria. (Photo courtesy Janice Haney Carr/CDC)

By PCR, 7 throat and 21 nares samples were MRSA positive; 33 throat and 51 nares swabs were positive for MSSA.

The detection rate differences weren’t surprising; PCR is known to be more accurate and the results confirm its greater sensitivity, Dr. Knofsky said at the annual meeting of the Surgical Infection Society.

The bigger finding is that "throat screening identifies additional patients missed by screening the nares alone," she said.

Adding PCR throat testing to PCR nasal screening picked up one additional MRSA and 14 additional MSSA carriers. Similarly, the addition of throat cultures to nares cultures picked up an additional MRSA and eight additional MSSA carriers.

Not infrequently, patients were positive in one location, such as the throat, but not in the other. Although "nasal carrier status of Staphylococcus aureus is an important risk factor for surgical site infections," it’s not known at the moment if that’s also true for carriage limited to the throat, Dr. Knofsky said.

"We have plans to go back and evaluate which of these patients colonized only in the oropharynx actually developed a surgical site infection. It’s important that we invest in evaluating pharyngeal carriage," she said.

In the meantime, session moderator and surgeon Dr. E. Patchen Dellinger of the University of Washington in Seattle, noted that MSSA in the study "was two to three times more common than MRSA; an MSSA infection of implanted hardware is just as devastating to the patient as an MRSA infection. I would like to urge that we not focus on MRSA alone, but consider at least in selected surgical populations seeking and suppressing any Staph that colonizes our surgical patients."

PCR could help with that because it "has the advantage of very rapid answers. The logistics of getting [colonization] information in time to do something [before an operation] is very difficult for us. PCR could make that better, [but it] isn’t standard of care mostly because it costs a lot more" than does culture, he said.

Dr. Knofsky and Dr. Dellinger said they have no relevant disclosures.

[email protected]

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Major finding: In an analysis of 109 throat and nares swabs, the addition of PCR throat testing to PCR nasal screening picked up one additional MRSA and 14 additional MSSA carriers. Similarly, the addition of throat cultures to nares cultures picked up an additional MRSA and eight additional MSSA carriers.

Data source: Samples from presurgical patients

Disclosures: The lead investigator said she has no disclosures.

Concussion recovery takes longer if children have had one before

Kids need patience during recovery
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Children and teenagers take longer to recover from a concussion if they’ve had one before, especially within the past year, Boston Children’s Hospital emergency department physicians found in a study of 280 of their concussed patients published June 10 in Pediatrics.

The median duration of symptoms, assessed by the serial Rivermead Post-Concussion Symptoms Questionnaire (RPSQ) over a period of 3 months, climbed from 12 days in patients who hadn’t been concussed before to 24 days in those who had. The median symptom duration was 28 days in patients with multiple previous concussions, and 35 days in those who’d been concussed within the previous year, "nearly three times the median duration [for] those who had no previous concussions," according to Dr. Matthew A. Eisenberg and his associates at the hospital (Pediatrics 2013 [doi:10.1542/peds.2013-0432]).

"Similarly, patients with two or more previous concussions had more than double the median symptom duration [of] patients with zero or one previous concussion," they found.

On multivariate analysis, previous concussion, maintaining consciousness, being 13 years or older, and an initial RPSQ of 18 or higher all predicted prolonged recovery. Among all comers, 77% had symptoms at 1 week, 32% at 4 weeks, and 15% at 3 months. The mean age in the trial was 14.3 years (range, 11-22 years).

The findings were statistically significant and have "direct implications on the management of athletes and other at-risk individuals who sustain concussions, supporting the concept that sufficient time to recover from a concussion may improve long-term outcomes," the investigators said.

"However, we did not find an association between physician-advised cognitive or physical rest and duration of symptoms, which may reflect the limitations of our observational study," they added. "A randomized [controlled] trial will likely be necessary to address the utility of this intervention."

Sixty-six percent of the subjects were enrolled the day they were injured; 24.7% were enrolled 1 day later, 7.2% 2 days later, and 1.7% 3 days later. The majority (63.8%) had been injured playing hockey, soccer, football, basketball or some other sport.

The investigators defined concussion broadly to include either altered mental status following blunt head trauma or, within 4 hours of it, any of the following symptoms that were not present before the injury: headache, nausea, vomiting, dizziness/balance problems, fatigue, drowsiness, blurred vision, memory difficulty, or trouble concentrating.

The most common symptoms in the study were headache (85.1%), fatigue (64.7%), and dizziness (63.0%); 4.3% of subjects had altered gait or balance, and 2.4% had altered mental status. There were no abnormalities in the 20.8% of kids who got neuroimaging.

On discharge, 65.9% were prescribed a period of cognitive rest and 92.4% were told to take time off from sports; 63.8% were also told to follow up with their primary care doctor, 45.5% with a sports concussion clinic, and 6.2% with a specialist.

In contrast to prior studies, loss of consciousness seemed to protect against a prolonged recovery (HR, 0.648; P = .02). Maybe the 22% of kids who got knocked out were more likely to follow their doctors’ advice to rest, "thus speeding recovery from their injury. We cannot, however, eliminate the possibility that there is a biological basis to this finding," the team noted.

Subjects who were 13 years or older might have taken longer to recover (HR, 1.404; P = .04) because games "between older children involve more contact and higher-force impacts," although neurobiologic differences between older and younger kids might have played a role, as well, the investigators said.

"Female patients" – about 43% of the study total – "had more severe symptoms at presentation in our study (mean initial RPSQ of 21.3 vs. 17.0 in male patients, P = .02). ... Whether this finding is indicative of the fact that female patients have more severe symptoms from concussion in general, as suggested in several previous studies, or is due to referral bias in which female individuals preferentially present to the ED when symptoms are more severe ... cannot be ascertained from our data," they noted.

Female gender fell out on multivariate analysis as a predictor of prolonged recovery (HR, 1.294; P= 0.11).

The investigators said they had no relevant financial disclosures.

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This study is "incredibly interesting. It’s amazing to think that as recently as 5-7 years ago, people were still operating under the advice that 90% of concussion patients get better within a week. You can still find that online every now and then. But clearly, whether they’ve had multiple concussions or not, recovery time is longer for teens and preteens than anyone has expected in the past. This backs up what I see in the clinic," said Dr. Kevin Walter.

So, if kids come to the office a week or 2 after a concussion and say they’re all better, they are "going to be the exception to the rule." More likely, they are not being honest with themselves or are a bit too eager to get back into the game or classroom, he said.

"You don’t want to let the athlete make the decision on their own that they’re better. [Sometimes] ERs [still] send them out saying that ‘if you still feel bad in a week, then go get seen. Otherwise, get back into sport[s],’ " he said.

Follow-up is critical to prevent that from happening. "The gold standard is moving towards multidisciplinary care with physicians and neuropsychologists, with the input of a school athletic trainer. [In my clinic,] the luxury of having a neuropsychologist is wonderful; they’ve got the cognitive function testing" to uncover subtle problems, "and they’ve got more time [to work with patients] and expertise on how to deliver the tests appropriately," Dr. Walter said.

No matter how hard it is for young patients to power down for a bit, "we know without a doubt that kids need some degree of cognitive rest and physical rest from activity and sports" after a concussion. It’s troubling in the study "that only 92% of people who had a concussion were told to refrain from athletics. That should be 100%; that’s the goal we need to shoot for," he said.

For now, it’s unclear if there’s a gap between when kids feel better and when they are truly physiologically recovered, and if they are especially vulnerable to another concussion in between. Also, although it’s been recognized before that kid concussions are different than ones in adults, what exactly that means for treatment is uncertain at this point.

Even so, "for most kids, we need to move a little bit more slowly" than in the past, he said.

Dr. Walter is an associate professor in the departments of orthopedic surgery and pediatrics at the Medical College of Wisconsin in Milwaukee, cofounder of the college’s Sports Concussion Program, and a member of the Institute of Medicine’s Committee on Sports-Related Concussions in Youth. He was lead author of the American Academy of Pediatrics’ clinical report "Sport-Related Concussion in Children and Adolescents."

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This study is "incredibly interesting. It’s amazing to think that as recently as 5-7 years ago, people were still operating under the advice that 90% of concussion patients get better within a week. You can still find that online every now and then. But clearly, whether they’ve had multiple concussions or not, recovery time is longer for teens and preteens than anyone has expected in the past. This backs up what I see in the clinic," said Dr. Kevin Walter.

So, if kids come to the office a week or 2 after a concussion and say they’re all better, they are "going to be the exception to the rule." More likely, they are not being honest with themselves or are a bit too eager to get back into the game or classroom, he said.

"You don’t want to let the athlete make the decision on their own that they’re better. [Sometimes] ERs [still] send them out saying that ‘if you still feel bad in a week, then go get seen. Otherwise, get back into sport[s],’ " he said.

Follow-up is critical to prevent that from happening. "The gold standard is moving towards multidisciplinary care with physicians and neuropsychologists, with the input of a school athletic trainer. [In my clinic,] the luxury of having a neuropsychologist is wonderful; they’ve got the cognitive function testing" to uncover subtle problems, "and they’ve got more time [to work with patients] and expertise on how to deliver the tests appropriately," Dr. Walter said.

No matter how hard it is for young patients to power down for a bit, "we know without a doubt that kids need some degree of cognitive rest and physical rest from activity and sports" after a concussion. It’s troubling in the study "that only 92% of people who had a concussion were told to refrain from athletics. That should be 100%; that’s the goal we need to shoot for," he said.

For now, it’s unclear if there’s a gap between when kids feel better and when they are truly physiologically recovered, and if they are especially vulnerable to another concussion in between. Also, although it’s been recognized before that kid concussions are different than ones in adults, what exactly that means for treatment is uncertain at this point.

Even so, "for most kids, we need to move a little bit more slowly" than in the past, he said.

Dr. Walter is an associate professor in the departments of orthopedic surgery and pediatrics at the Medical College of Wisconsin in Milwaukee, cofounder of the college’s Sports Concussion Program, and a member of the Institute of Medicine’s Committee on Sports-Related Concussions in Youth. He was lead author of the American Academy of Pediatrics’ clinical report "Sport-Related Concussion in Children and Adolescents."

Body

This study is "incredibly interesting. It’s amazing to think that as recently as 5-7 years ago, people were still operating under the advice that 90% of concussion patients get better within a week. You can still find that online every now and then. But clearly, whether they’ve had multiple concussions or not, recovery time is longer for teens and preteens than anyone has expected in the past. This backs up what I see in the clinic," said Dr. Kevin Walter.

So, if kids come to the office a week or 2 after a concussion and say they’re all better, they are "going to be the exception to the rule." More likely, they are not being honest with themselves or are a bit too eager to get back into the game or classroom, he said.

"You don’t want to let the athlete make the decision on their own that they’re better. [Sometimes] ERs [still] send them out saying that ‘if you still feel bad in a week, then go get seen. Otherwise, get back into sport[s],’ " he said.

Follow-up is critical to prevent that from happening. "The gold standard is moving towards multidisciplinary care with physicians and neuropsychologists, with the input of a school athletic trainer. [In my clinic,] the luxury of having a neuropsychologist is wonderful; they’ve got the cognitive function testing" to uncover subtle problems, "and they’ve got more time [to work with patients] and expertise on how to deliver the tests appropriately," Dr. Walter said.

No matter how hard it is for young patients to power down for a bit, "we know without a doubt that kids need some degree of cognitive rest and physical rest from activity and sports" after a concussion. It’s troubling in the study "that only 92% of people who had a concussion were told to refrain from athletics. That should be 100%; that’s the goal we need to shoot for," he said.

For now, it’s unclear if there’s a gap between when kids feel better and when they are truly physiologically recovered, and if they are especially vulnerable to another concussion in between. Also, although it’s been recognized before that kid concussions are different than ones in adults, what exactly that means for treatment is uncertain at this point.

Even so, "for most kids, we need to move a little bit more slowly" than in the past, he said.

Dr. Walter is an associate professor in the departments of orthopedic surgery and pediatrics at the Medical College of Wisconsin in Milwaukee, cofounder of the college’s Sports Concussion Program, and a member of the Institute of Medicine’s Committee on Sports-Related Concussions in Youth. He was lead author of the American Academy of Pediatrics’ clinical report "Sport-Related Concussion in Children and Adolescents."

Title
Kids need patience during recovery
Kids need patience during recovery

Children and teenagers take longer to recover from a concussion if they’ve had one before, especially within the past year, Boston Children’s Hospital emergency department physicians found in a study of 280 of their concussed patients published June 10 in Pediatrics.

The median duration of symptoms, assessed by the serial Rivermead Post-Concussion Symptoms Questionnaire (RPSQ) over a period of 3 months, climbed from 12 days in patients who hadn’t been concussed before to 24 days in those who had. The median symptom duration was 28 days in patients with multiple previous concussions, and 35 days in those who’d been concussed within the previous year, "nearly three times the median duration [for] those who had no previous concussions," according to Dr. Matthew A. Eisenberg and his associates at the hospital (Pediatrics 2013 [doi:10.1542/peds.2013-0432]).

"Similarly, patients with two or more previous concussions had more than double the median symptom duration [of] patients with zero or one previous concussion," they found.

On multivariate analysis, previous concussion, maintaining consciousness, being 13 years or older, and an initial RPSQ of 18 or higher all predicted prolonged recovery. Among all comers, 77% had symptoms at 1 week, 32% at 4 weeks, and 15% at 3 months. The mean age in the trial was 14.3 years (range, 11-22 years).

The findings were statistically significant and have "direct implications on the management of athletes and other at-risk individuals who sustain concussions, supporting the concept that sufficient time to recover from a concussion may improve long-term outcomes," the investigators said.

"However, we did not find an association between physician-advised cognitive or physical rest and duration of symptoms, which may reflect the limitations of our observational study," they added. "A randomized [controlled] trial will likely be necessary to address the utility of this intervention."

Sixty-six percent of the subjects were enrolled the day they were injured; 24.7% were enrolled 1 day later, 7.2% 2 days later, and 1.7% 3 days later. The majority (63.8%) had been injured playing hockey, soccer, football, basketball or some other sport.

The investigators defined concussion broadly to include either altered mental status following blunt head trauma or, within 4 hours of it, any of the following symptoms that were not present before the injury: headache, nausea, vomiting, dizziness/balance problems, fatigue, drowsiness, blurred vision, memory difficulty, or trouble concentrating.

The most common symptoms in the study were headache (85.1%), fatigue (64.7%), and dizziness (63.0%); 4.3% of subjects had altered gait or balance, and 2.4% had altered mental status. There were no abnormalities in the 20.8% of kids who got neuroimaging.

On discharge, 65.9% were prescribed a period of cognitive rest and 92.4% were told to take time off from sports; 63.8% were also told to follow up with their primary care doctor, 45.5% with a sports concussion clinic, and 6.2% with a specialist.

In contrast to prior studies, loss of consciousness seemed to protect against a prolonged recovery (HR, 0.648; P = .02). Maybe the 22% of kids who got knocked out were more likely to follow their doctors’ advice to rest, "thus speeding recovery from their injury. We cannot, however, eliminate the possibility that there is a biological basis to this finding," the team noted.

Subjects who were 13 years or older might have taken longer to recover (HR, 1.404; P = .04) because games "between older children involve more contact and higher-force impacts," although neurobiologic differences between older and younger kids might have played a role, as well, the investigators said.

"Female patients" – about 43% of the study total – "had more severe symptoms at presentation in our study (mean initial RPSQ of 21.3 vs. 17.0 in male patients, P = .02). ... Whether this finding is indicative of the fact that female patients have more severe symptoms from concussion in general, as suggested in several previous studies, or is due to referral bias in which female individuals preferentially present to the ED when symptoms are more severe ... cannot be ascertained from our data," they noted.

Female gender fell out on multivariate analysis as a predictor of prolonged recovery (HR, 1.294; P= 0.11).

The investigators said they had no relevant financial disclosures.

Children and teenagers take longer to recover from a concussion if they’ve had one before, especially within the past year, Boston Children’s Hospital emergency department physicians found in a study of 280 of their concussed patients published June 10 in Pediatrics.

The median duration of symptoms, assessed by the serial Rivermead Post-Concussion Symptoms Questionnaire (RPSQ) over a period of 3 months, climbed from 12 days in patients who hadn’t been concussed before to 24 days in those who had. The median symptom duration was 28 days in patients with multiple previous concussions, and 35 days in those who’d been concussed within the previous year, "nearly three times the median duration [for] those who had no previous concussions," according to Dr. Matthew A. Eisenberg and his associates at the hospital (Pediatrics 2013 [doi:10.1542/peds.2013-0432]).

"Similarly, patients with two or more previous concussions had more than double the median symptom duration [of] patients with zero or one previous concussion," they found.

On multivariate analysis, previous concussion, maintaining consciousness, being 13 years or older, and an initial RPSQ of 18 or higher all predicted prolonged recovery. Among all comers, 77% had symptoms at 1 week, 32% at 4 weeks, and 15% at 3 months. The mean age in the trial was 14.3 years (range, 11-22 years).

The findings were statistically significant and have "direct implications on the management of athletes and other at-risk individuals who sustain concussions, supporting the concept that sufficient time to recover from a concussion may improve long-term outcomes," the investigators said.

"However, we did not find an association between physician-advised cognitive or physical rest and duration of symptoms, which may reflect the limitations of our observational study," they added. "A randomized [controlled] trial will likely be necessary to address the utility of this intervention."

Sixty-six percent of the subjects were enrolled the day they were injured; 24.7% were enrolled 1 day later, 7.2% 2 days later, and 1.7% 3 days later. The majority (63.8%) had been injured playing hockey, soccer, football, basketball or some other sport.

The investigators defined concussion broadly to include either altered mental status following blunt head trauma or, within 4 hours of it, any of the following symptoms that were not present before the injury: headache, nausea, vomiting, dizziness/balance problems, fatigue, drowsiness, blurred vision, memory difficulty, or trouble concentrating.

The most common symptoms in the study were headache (85.1%), fatigue (64.7%), and dizziness (63.0%); 4.3% of subjects had altered gait or balance, and 2.4% had altered mental status. There were no abnormalities in the 20.8% of kids who got neuroimaging.

On discharge, 65.9% were prescribed a period of cognitive rest and 92.4% were told to take time off from sports; 63.8% were also told to follow up with their primary care doctor, 45.5% with a sports concussion clinic, and 6.2% with a specialist.

In contrast to prior studies, loss of consciousness seemed to protect against a prolonged recovery (HR, 0.648; P = .02). Maybe the 22% of kids who got knocked out were more likely to follow their doctors’ advice to rest, "thus speeding recovery from their injury. We cannot, however, eliminate the possibility that there is a biological basis to this finding," the team noted.

Subjects who were 13 years or older might have taken longer to recover (HR, 1.404; P = .04) because games "between older children involve more contact and higher-force impacts," although neurobiologic differences between older and younger kids might have played a role, as well, the investigators said.

"Female patients" – about 43% of the study total – "had more severe symptoms at presentation in our study (mean initial RPSQ of 21.3 vs. 17.0 in male patients, P = .02). ... Whether this finding is indicative of the fact that female patients have more severe symptoms from concussion in general, as suggested in several previous studies, or is due to referral bias in which female individuals preferentially present to the ED when symptoms are more severe ... cannot be ascertained from our data," they noted.

Female gender fell out on multivariate analysis as a predictor of prolonged recovery (HR, 1.294; P= 0.11).

The investigators said they had no relevant financial disclosures.

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Major finding: The median duration of concussion symptoms was 12 days in children and teens who hadn’t been concussed before, 24 days in those who had, and 35 days in those who had been concussed within the previous year.

Data source: A prospective cohort study of 280 concussed patients aged 11-22 years.

Disclosures: The study was funded by Boston Children’s Hospital, where it was conducted. The investigators said they had no relevant financial disclosures.

Joint pain in children rules out JIA

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PORTLAND, ORE. – Joint pain isn’t usually part of the clinical picture when children have juvenile idiopathic arthritis, according to pediatric rheumatologist Victoria Cartwright.

"In fact, it helps you discount that juvenile arthritis is going on," she said at a conference sponsored by the North Pacific Pediatric Society.

Pain as an isolated complaint has a negative predictive value for pediatric rheumatic disease of 0.99 and, as one of several reasons for a rheumatology referral, a negative predictive value of 0.91 (Pediatrics 2002;110:354-9).

Dr. Victoria Cartwright

"That’s better than any lab test or x-ray [and] about as good as MRI. [So] if you’re calling me saying that Johnny has knee pain, I’m not as worried about JIA [juvenile idiopathic arthritis]. I may be worried about [Henoch-Schönlein purpura (HSP)] or a mechanical issue or something else ... but [not] JIA," said Dr. Cartwright of Randall Children’s Hospital at Legacy Emanuel in Portland, Ore.

On the other hand, "labs really don’t help one way or the other to make the diagnosis of arthritis. Rheumatoid factor doesn’t help. [Erythrocyte sedimentation rate] is helpful if it’s abnormal, but only kind of. I can have a kid who has 20 inflamed joints and their sed rate is 2; I can have another kid with one swollen knee, and their sed rate is 30. [However,] if the sed rate is over 100, I worry about other stuff," such as systemic disease, lupus, HSP, vasculitis, or malignancy, she said.

If those problems have been ruled out, Dr. Cartwright said she usually waits until kids have been on NSAIDs – she favors weight-dosed ibuprofen or naproxen – for a month before getting a complete blood count, a liver enzyme panel, and an antinuclear antibody (ANA) test. "I’m not a big fan of labs up front" for JIA "because we end up chasing the lab illness a little bit," she said. JIA kids also need a referral to an ophthalmologist to check for iritis. If this condition is present, ANA testing helps tell how aggressive it is.

As for assessment, Dr. Cartwright noted that obesity makes it tough to check the ankle for swelling; extra pounds obscure the Achilles tendon and the divots to either side. "It’s one of the joints I image a lot with MRI because I [often] can’t see it very well," she said.

Swelling can be hard to detect in kids with polyarticular disease because it can be more or less even on either side of the body, and, thus, less noticeable. One trick, especially helpful with the hands, is to compare the skin folds and wrinkles around corresponding joints. If they aren’t symmetrical, it could be due to swelling.

Check for jaw arthritis, too, Dr. Cartwright said. A lot of children don’t even know there’s a problem because it’s painless, but left unchecked, jaw arthritis can cause growth abnormalities – associated asymmetries are most obvious when the head’s tilted back – and make it difficult to fully open the mouth.

Patients should be able to insert their three middle fingers vertically into their mouth. When they can’t, "we do some dynamic stretching. We’ll stack tongue blades" to reach the appropriate thickness and have patients place them in their mouth to "stretch the muscles out, kind of like doing [physical therapy]," Dr. Cartwright said.

She said she has no relevant financial disclosures.

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PORTLAND, ORE. – Joint pain isn’t usually part of the clinical picture when children have juvenile idiopathic arthritis, according to pediatric rheumatologist Victoria Cartwright.

"In fact, it helps you discount that juvenile arthritis is going on," she said at a conference sponsored by the North Pacific Pediatric Society.

Pain as an isolated complaint has a negative predictive value for pediatric rheumatic disease of 0.99 and, as one of several reasons for a rheumatology referral, a negative predictive value of 0.91 (Pediatrics 2002;110:354-9).

Dr. Victoria Cartwright

"That’s better than any lab test or x-ray [and] about as good as MRI. [So] if you’re calling me saying that Johnny has knee pain, I’m not as worried about JIA [juvenile idiopathic arthritis]. I may be worried about [Henoch-Schönlein purpura (HSP)] or a mechanical issue or something else ... but [not] JIA," said Dr. Cartwright of Randall Children’s Hospital at Legacy Emanuel in Portland, Ore.

On the other hand, "labs really don’t help one way or the other to make the diagnosis of arthritis. Rheumatoid factor doesn’t help. [Erythrocyte sedimentation rate] is helpful if it’s abnormal, but only kind of. I can have a kid who has 20 inflamed joints and their sed rate is 2; I can have another kid with one swollen knee, and their sed rate is 30. [However,] if the sed rate is over 100, I worry about other stuff," such as systemic disease, lupus, HSP, vasculitis, or malignancy, she said.

If those problems have been ruled out, Dr. Cartwright said she usually waits until kids have been on NSAIDs – she favors weight-dosed ibuprofen or naproxen – for a month before getting a complete blood count, a liver enzyme panel, and an antinuclear antibody (ANA) test. "I’m not a big fan of labs up front" for JIA "because we end up chasing the lab illness a little bit," she said. JIA kids also need a referral to an ophthalmologist to check for iritis. If this condition is present, ANA testing helps tell how aggressive it is.

As for assessment, Dr. Cartwright noted that obesity makes it tough to check the ankle for swelling; extra pounds obscure the Achilles tendon and the divots to either side. "It’s one of the joints I image a lot with MRI because I [often] can’t see it very well," she said.

Swelling can be hard to detect in kids with polyarticular disease because it can be more or less even on either side of the body, and, thus, less noticeable. One trick, especially helpful with the hands, is to compare the skin folds and wrinkles around corresponding joints. If they aren’t symmetrical, it could be due to swelling.

Check for jaw arthritis, too, Dr. Cartwright said. A lot of children don’t even know there’s a problem because it’s painless, but left unchecked, jaw arthritis can cause growth abnormalities – associated asymmetries are most obvious when the head’s tilted back – and make it difficult to fully open the mouth.

Patients should be able to insert their three middle fingers vertically into their mouth. When they can’t, "we do some dynamic stretching. We’ll stack tongue blades" to reach the appropriate thickness and have patients place them in their mouth to "stretch the muscles out, kind of like doing [physical therapy]," Dr. Cartwright said.

She said she has no relevant financial disclosures.

[email protected]

PORTLAND, ORE. – Joint pain isn’t usually part of the clinical picture when children have juvenile idiopathic arthritis, according to pediatric rheumatologist Victoria Cartwright.

"In fact, it helps you discount that juvenile arthritis is going on," she said at a conference sponsored by the North Pacific Pediatric Society.

Pain as an isolated complaint has a negative predictive value for pediatric rheumatic disease of 0.99 and, as one of several reasons for a rheumatology referral, a negative predictive value of 0.91 (Pediatrics 2002;110:354-9).

Dr. Victoria Cartwright

"That’s better than any lab test or x-ray [and] about as good as MRI. [So] if you’re calling me saying that Johnny has knee pain, I’m not as worried about JIA [juvenile idiopathic arthritis]. I may be worried about [Henoch-Schönlein purpura (HSP)] or a mechanical issue or something else ... but [not] JIA," said Dr. Cartwright of Randall Children’s Hospital at Legacy Emanuel in Portland, Ore.

On the other hand, "labs really don’t help one way or the other to make the diagnosis of arthritis. Rheumatoid factor doesn’t help. [Erythrocyte sedimentation rate] is helpful if it’s abnormal, but only kind of. I can have a kid who has 20 inflamed joints and their sed rate is 2; I can have another kid with one swollen knee, and their sed rate is 30. [However,] if the sed rate is over 100, I worry about other stuff," such as systemic disease, lupus, HSP, vasculitis, or malignancy, she said.

If those problems have been ruled out, Dr. Cartwright said she usually waits until kids have been on NSAIDs – she favors weight-dosed ibuprofen or naproxen – for a month before getting a complete blood count, a liver enzyme panel, and an antinuclear antibody (ANA) test. "I’m not a big fan of labs up front" for JIA "because we end up chasing the lab illness a little bit," she said. JIA kids also need a referral to an ophthalmologist to check for iritis. If this condition is present, ANA testing helps tell how aggressive it is.

As for assessment, Dr. Cartwright noted that obesity makes it tough to check the ankle for swelling; extra pounds obscure the Achilles tendon and the divots to either side. "It’s one of the joints I image a lot with MRI because I [often] can’t see it very well," she said.

Swelling can be hard to detect in kids with polyarticular disease because it can be more or less even on either side of the body, and, thus, less noticeable. One trick, especially helpful with the hands, is to compare the skin folds and wrinkles around corresponding joints. If they aren’t symmetrical, it could be due to swelling.

Check for jaw arthritis, too, Dr. Cartwright said. A lot of children don’t even know there’s a problem because it’s painless, but left unchecked, jaw arthritis can cause growth abnormalities – associated asymmetries are most obvious when the head’s tilted back – and make it difficult to fully open the mouth.

Patients should be able to insert their three middle fingers vertically into their mouth. When they can’t, "we do some dynamic stretching. We’ll stack tongue blades" to reach the appropriate thickness and have patients place them in their mouth to "stretch the muscles out, kind of like doing [physical therapy]," Dr. Cartwright said.

She said she has no relevant financial disclosures.

[email protected]

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Hold off on the debriefing following a time-out

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PORTLAND, ORE. – When time-outs don’t work, it’s often because they aren’t being done right, according to Dr. Barbara J. Howard.

Time-outs are "the best evidence-based consequence to change unwanted behavior," effective from as early as 9 months old – when some children are already hitting – and most effective between ages 2-6 years, said Dr. Howard, an assistant professor of pediatrics at Johns Hopkins University in Baltimore.

Dr. Barbara J. Howard

But parents first need to be taught how to do time-outs right, and practice them; that’s best done before they’re ever needed.

They should know that time-outs should be reserved for just a few serious offenses, such as hitting, kicking, or swearing, and that they are not a substitute for good parenting. If "the kid’s in time-out more than once a day, they are probably not getting enough positive attention for positive behaviors," Dr. Howard said at a conference sponsored by the North Pacific Pediatric Society.

Time-outs for aggressive behavior shouldn’t come with a warning beforehand. Instead, the child should get a brief statement of the offense – for instance, " ‘No hitting, hitting hurts, you’re in time-out.’ Then put [the child] in an uninteresting, but not-scary place." There should be no interaction while the sentence is served. Restraints are an option if the child squirms out of the chair, as is restarting the clock if they act up, said the pediatric developmental and behavioral specialist.

The general rule is 1 minute for each year of age, but if a child with attention-deficit/hyperactivity disorder (ADHD) is unable to sit for a few minutes, even 15 seconds can work. "Have the parent sort of watch them out of the corner of their eye. As soon as the child gives in to the fact that they are sitting there" – lets out a sigh, for example – "that’s the time to [let] them out," she said.

There shouldn’t be a discussion or lecture about what they did wrong when the time’s up. "They are so delicate when they come out of being given a consequence that they fall apart very easily, so it’s better not to talk about it at that moment because they can’t [hear] the lesson." A discussion is just likely to rekindle the situation, Dr. Howard said.

Instead, "return to the scene of the crime and distract them onto some new activity that they can be praised for. Find something positive about their behavior to talk about, or at least give them neutral attention," she said.

And "don’t ask them to apologize. First of all, are they sorry? No. So, if you force them to apologize, you are telling them to lie. That’s not good. [However,] it is appropriate for the adult to apologize to the victim" by saying something like "Oh, I’m sorry you got hurt. That must hurt a lot." The offender just might incorporate the example into their own behavior, she said.

It’s time to revisit the offense later on, after the storm’s passed. The child can be asked what they could have done differently, and given some different options. Role-playing helps.

Parents also need to know that "it’s quite common" for children to go back and do the exact same thing that got them into trouble in the first place, "but that doesn’t mean that the time-out didn’t work; the same thing is true if they get [spanked]. So you can reassure parents they aren’t crazy if they see [that time-outs are] not immediately effective. Tell them to hang in there, and expect change over time," Dr. Howard said.

Dr. Howard is the creator of CHADIS and president of Total Child Health, the management company that licenses its use.

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PORTLAND, ORE. – When time-outs don’t work, it’s often because they aren’t being done right, according to Dr. Barbara J. Howard.

Time-outs are "the best evidence-based consequence to change unwanted behavior," effective from as early as 9 months old – when some children are already hitting – and most effective between ages 2-6 years, said Dr. Howard, an assistant professor of pediatrics at Johns Hopkins University in Baltimore.

Dr. Barbara J. Howard

But parents first need to be taught how to do time-outs right, and practice them; that’s best done before they’re ever needed.

They should know that time-outs should be reserved for just a few serious offenses, such as hitting, kicking, or swearing, and that they are not a substitute for good parenting. If "the kid’s in time-out more than once a day, they are probably not getting enough positive attention for positive behaviors," Dr. Howard said at a conference sponsored by the North Pacific Pediatric Society.

Time-outs for aggressive behavior shouldn’t come with a warning beforehand. Instead, the child should get a brief statement of the offense – for instance, " ‘No hitting, hitting hurts, you’re in time-out.’ Then put [the child] in an uninteresting, but not-scary place." There should be no interaction while the sentence is served. Restraints are an option if the child squirms out of the chair, as is restarting the clock if they act up, said the pediatric developmental and behavioral specialist.

The general rule is 1 minute for each year of age, but if a child with attention-deficit/hyperactivity disorder (ADHD) is unable to sit for a few minutes, even 15 seconds can work. "Have the parent sort of watch them out of the corner of their eye. As soon as the child gives in to the fact that they are sitting there" – lets out a sigh, for example – "that’s the time to [let] them out," she said.

There shouldn’t be a discussion or lecture about what they did wrong when the time’s up. "They are so delicate when they come out of being given a consequence that they fall apart very easily, so it’s better not to talk about it at that moment because they can’t [hear] the lesson." A discussion is just likely to rekindle the situation, Dr. Howard said.

Instead, "return to the scene of the crime and distract them onto some new activity that they can be praised for. Find something positive about their behavior to talk about, or at least give them neutral attention," she said.

And "don’t ask them to apologize. First of all, are they sorry? No. So, if you force them to apologize, you are telling them to lie. That’s not good. [However,] it is appropriate for the adult to apologize to the victim" by saying something like "Oh, I’m sorry you got hurt. That must hurt a lot." The offender just might incorporate the example into their own behavior, she said.

It’s time to revisit the offense later on, after the storm’s passed. The child can be asked what they could have done differently, and given some different options. Role-playing helps.

Parents also need to know that "it’s quite common" for children to go back and do the exact same thing that got them into trouble in the first place, "but that doesn’t mean that the time-out didn’t work; the same thing is true if they get [spanked]. So you can reassure parents they aren’t crazy if they see [that time-outs are] not immediately effective. Tell them to hang in there, and expect change over time," Dr. Howard said.

Dr. Howard is the creator of CHADIS and president of Total Child Health, the management company that licenses its use.

[email protected]

PORTLAND, ORE. – When time-outs don’t work, it’s often because they aren’t being done right, according to Dr. Barbara J. Howard.

Time-outs are "the best evidence-based consequence to change unwanted behavior," effective from as early as 9 months old – when some children are already hitting – and most effective between ages 2-6 years, said Dr. Howard, an assistant professor of pediatrics at Johns Hopkins University in Baltimore.

Dr. Barbara J. Howard

But parents first need to be taught how to do time-outs right, and practice them; that’s best done before they’re ever needed.

They should know that time-outs should be reserved for just a few serious offenses, such as hitting, kicking, or swearing, and that they are not a substitute for good parenting. If "the kid’s in time-out more than once a day, they are probably not getting enough positive attention for positive behaviors," Dr. Howard said at a conference sponsored by the North Pacific Pediatric Society.

Time-outs for aggressive behavior shouldn’t come with a warning beforehand. Instead, the child should get a brief statement of the offense – for instance, " ‘No hitting, hitting hurts, you’re in time-out.’ Then put [the child] in an uninteresting, but not-scary place." There should be no interaction while the sentence is served. Restraints are an option if the child squirms out of the chair, as is restarting the clock if they act up, said the pediatric developmental and behavioral specialist.

The general rule is 1 minute for each year of age, but if a child with attention-deficit/hyperactivity disorder (ADHD) is unable to sit for a few minutes, even 15 seconds can work. "Have the parent sort of watch them out of the corner of their eye. As soon as the child gives in to the fact that they are sitting there" – lets out a sigh, for example – "that’s the time to [let] them out," she said.

There shouldn’t be a discussion or lecture about what they did wrong when the time’s up. "They are so delicate when they come out of being given a consequence that they fall apart very easily, so it’s better not to talk about it at that moment because they can’t [hear] the lesson." A discussion is just likely to rekindle the situation, Dr. Howard said.

Instead, "return to the scene of the crime and distract them onto some new activity that they can be praised for. Find something positive about their behavior to talk about, or at least give them neutral attention," she said.

And "don’t ask them to apologize. First of all, are they sorry? No. So, if you force them to apologize, you are telling them to lie. That’s not good. [However,] it is appropriate for the adult to apologize to the victim" by saying something like "Oh, I’m sorry you got hurt. That must hurt a lot." The offender just might incorporate the example into their own behavior, she said.

It’s time to revisit the offense later on, after the storm’s passed. The child can be asked what they could have done differently, and given some different options. Role-playing helps.

Parents also need to know that "it’s quite common" for children to go back and do the exact same thing that got them into trouble in the first place, "but that doesn’t mean that the time-out didn’t work; the same thing is true if they get [spanked]. So you can reassure parents they aren’t crazy if they see [that time-outs are] not immediately effective. Tell them to hang in there, and expect change over time," Dr. Howard said.

Dr. Howard is the creator of CHADIS and president of Total Child Health, the management company that licenses its use.

[email protected]

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Use of 'liberation therapy' may make MS worse

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SAN DIEGO -- Percutaneous transluminal venous angioplasty – also known as "liberation therapy" -- doesn't help people with multiple sclerosis and may increase MS brain activity in the short term, according to a small, randomized, sham-controlled trial from the State University of New York at Buffalo, the first randomized trial to investigate the procedure.

The technique "was ineffective in correcting" chronic cerebrospinal venous insufficiency (CCSVI), the recently described condition it targets. "The results ... caution against widespread adoption of venous angioplasty in the management of patients with MS outside of rigorous clinical trials," the investigators concluded.

  Dr. Robert Zivadinov

The findings follow a recent Food and Drug Administration warning that PTVA (percutaneous transluminal venous angioplasty) can cause deaths and injuries, including strokes, damage to the treated vein, blood clots, cranial nerve damage, abdominal bleeding, and detachment and migration of stents.

The idea is to use balloon angioplasty and stents to widen veins in the chest and neck that appear to be narrowed in some MS patients. Proponents of the procedure say that those narrowed veins impair blood flow and lead to disease progression. The researchers who discovered the problem dubbed it CCSVI. A cottage industry has since sprung up to offer PTVA to MS patients.

The FDA noted in its warning that there have been no "controlled ... rigorously conducted, properly targeted" studies of the issue; that may have changed when Dr. Robert Zivadinov, a professor in the department of neurology at SUNY-Buffalo, presented his team’s findings at the annual meeting of the American Academy of Neurology.

"When you reopened those veins in the neck, I think something happened in reperfusing the brain and re-exacerbating disease activity. The message of this is clear. The majority of patients who are relapsing-remitting should not undergo this treatment," he said in an interview.

Ten patients got PTVA in the first phase of the study. The second phase randomized 9 to PTVA and 10 to a sham intervention. Most had relapsing-remitting MS.

There were no MS relapses in the first phase, but PTVA patients had more relapses (4 vs. 1; P = .389) and more MRI disease activity (cumulative number of new contrast-enhancing lesions (19 vs. 3; P = .062) and new T2 lesions (17 vs. 3; P = .066) in the 6 months following treatment in phase II.

PTVA patients also didn’t fare any better on Expanded Disability Status Scale (EDSS) scores, Multiple Sclerosis Functional Composite scores, 6-minute walk tests, or measures of cognition and quality of life.

"We chose very active patients who had one relapse in the previous year or [gadolinium-] enhancing lesions in the 3 months before. The sample size is small, but [more than half] of patients in the treatment group showed increased activity," Dr. Zivadinov said.

The majority of the subjects were women. On average, they were about 45 years old, had been diagnosed with MS for 11 years, and were mildly to moderately disabled (mean EDSS score about 4). Most were on interferon, glatiramer acetate, or both.

Venous angioplasty didn’t cause any serious complications, and it restored venous outflow to at least 50% of normal in most patients. Phase I patients had a better than 75% improvement overall. Phase II patients had less benefit; there were no differences in venous hemodynamic insufficiency scores between treated and sham patients.

The treatment "failed to provide any sustained improvement in venous outflow as measured through duplex and/or clinical and MRI outcomes," and "more sizable changes in venous outflow [were] associated with increased disease activity primarily noted on MRI," Dr. Zivadinov and his colleagues concluded.

The work was funded primarily by SUNY-Buffalo’s Neuroimaging Analysis Center and Baird MS Research Center. Dr. Zivadinov receives personal compensation from Teva Pharmaceuticals, Biogen Idec, EMD Serono, Bayer, Genzyme-Sanofi, Novartis, Bracco Imaging, and Questcor Pharmaceuticals.

[email protected]

Body

The possibility of a causal relationship between MS and CCSVI gave patients with that chronic, debilitating, relapsing disease a glimmer of hope. Anecdotal reports of dramatic improvement with "liberation therapy" for treatment of MS raised expectations even further and created a demand for CCSVI interventions. Still, many vascular and neurological specialists remained skeptical of this approach, citing the lack of high-level evidence to support it. Some were even accused (mostly by patients) of withholding an effective treatment, while advocates of intervention tended to minimize the risks and cost involved. In spite of the controversy surrounding MS and CCSVI, there should be agreement that the "gold standard" for determining treatment efficacy is the randomized controlled clinical trial, and liberation therapy must be held to that standard. While not definitive, the small trial summarized here is a step in the right direction.

Dr. Robert Eugene Zierler, MD, is at the University of Washington, Seattle.

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The possibility of a causal relationship between MS and CCSVI gave patients with that chronic, debilitating, relapsing disease a glimmer of hope. Anecdotal reports of dramatic improvement with "liberation therapy" for treatment of MS raised expectations even further and created a demand for CCSVI interventions. Still, many vascular and neurological specialists remained skeptical of this approach, citing the lack of high-level evidence to support it. Some were even accused (mostly by patients) of withholding an effective treatment, while advocates of intervention tended to minimize the risks and cost involved. In spite of the controversy surrounding MS and CCSVI, there should be agreement that the "gold standard" for determining treatment efficacy is the randomized controlled clinical trial, and liberation therapy must be held to that standard. While not definitive, the small trial summarized here is a step in the right direction.

Dr. Robert Eugene Zierler, MD, is at the University of Washington, Seattle.

Body

The possibility of a causal relationship between MS and CCSVI gave patients with that chronic, debilitating, relapsing disease a glimmer of hope. Anecdotal reports of dramatic improvement with "liberation therapy" for treatment of MS raised expectations even further and created a demand for CCSVI interventions. Still, many vascular and neurological specialists remained skeptical of this approach, citing the lack of high-level evidence to support it. Some were even accused (mostly by patients) of withholding an effective treatment, while advocates of intervention tended to minimize the risks and cost involved. In spite of the controversy surrounding MS and CCSVI, there should be agreement that the "gold standard" for determining treatment efficacy is the randomized controlled clinical trial, and liberation therapy must be held to that standard. While not definitive, the small trial summarized here is a step in the right direction.

Dr. Robert Eugene Zierler, MD, is at the University of Washington, Seattle.

Title
A step in the right direction
A step in the right direction

SAN DIEGO -- Percutaneous transluminal venous angioplasty – also known as "liberation therapy" -- doesn't help people with multiple sclerosis and may increase MS brain activity in the short term, according to a small, randomized, sham-controlled trial from the State University of New York at Buffalo, the first randomized trial to investigate the procedure.

The technique "was ineffective in correcting" chronic cerebrospinal venous insufficiency (CCSVI), the recently described condition it targets. "The results ... caution against widespread adoption of venous angioplasty in the management of patients with MS outside of rigorous clinical trials," the investigators concluded.

  Dr. Robert Zivadinov

The findings follow a recent Food and Drug Administration warning that PTVA (percutaneous transluminal venous angioplasty) can cause deaths and injuries, including strokes, damage to the treated vein, blood clots, cranial nerve damage, abdominal bleeding, and detachment and migration of stents.

The idea is to use balloon angioplasty and stents to widen veins in the chest and neck that appear to be narrowed in some MS patients. Proponents of the procedure say that those narrowed veins impair blood flow and lead to disease progression. The researchers who discovered the problem dubbed it CCSVI. A cottage industry has since sprung up to offer PTVA to MS patients.

The FDA noted in its warning that there have been no "controlled ... rigorously conducted, properly targeted" studies of the issue; that may have changed when Dr. Robert Zivadinov, a professor in the department of neurology at SUNY-Buffalo, presented his team’s findings at the annual meeting of the American Academy of Neurology.

"When you reopened those veins in the neck, I think something happened in reperfusing the brain and re-exacerbating disease activity. The message of this is clear. The majority of patients who are relapsing-remitting should not undergo this treatment," he said in an interview.

Ten patients got PTVA in the first phase of the study. The second phase randomized 9 to PTVA and 10 to a sham intervention. Most had relapsing-remitting MS.

There were no MS relapses in the first phase, but PTVA patients had more relapses (4 vs. 1; P = .389) and more MRI disease activity (cumulative number of new contrast-enhancing lesions (19 vs. 3; P = .062) and new T2 lesions (17 vs. 3; P = .066) in the 6 months following treatment in phase II.

PTVA patients also didn’t fare any better on Expanded Disability Status Scale (EDSS) scores, Multiple Sclerosis Functional Composite scores, 6-minute walk tests, or measures of cognition and quality of life.

"We chose very active patients who had one relapse in the previous year or [gadolinium-] enhancing lesions in the 3 months before. The sample size is small, but [more than half] of patients in the treatment group showed increased activity," Dr. Zivadinov said.

The majority of the subjects were women. On average, they were about 45 years old, had been diagnosed with MS for 11 years, and were mildly to moderately disabled (mean EDSS score about 4). Most were on interferon, glatiramer acetate, or both.

Venous angioplasty didn’t cause any serious complications, and it restored venous outflow to at least 50% of normal in most patients. Phase I patients had a better than 75% improvement overall. Phase II patients had less benefit; there were no differences in venous hemodynamic insufficiency scores between treated and sham patients.

The treatment "failed to provide any sustained improvement in venous outflow as measured through duplex and/or clinical and MRI outcomes," and "more sizable changes in venous outflow [were] associated with increased disease activity primarily noted on MRI," Dr. Zivadinov and his colleagues concluded.

The work was funded primarily by SUNY-Buffalo’s Neuroimaging Analysis Center and Baird MS Research Center. Dr. Zivadinov receives personal compensation from Teva Pharmaceuticals, Biogen Idec, EMD Serono, Bayer, Genzyme-Sanofi, Novartis, Bracco Imaging, and Questcor Pharmaceuticals.

[email protected]

SAN DIEGO -- Percutaneous transluminal venous angioplasty – also known as "liberation therapy" -- doesn't help people with multiple sclerosis and may increase MS brain activity in the short term, according to a small, randomized, sham-controlled trial from the State University of New York at Buffalo, the first randomized trial to investigate the procedure.

The technique "was ineffective in correcting" chronic cerebrospinal venous insufficiency (CCSVI), the recently described condition it targets. "The results ... caution against widespread adoption of venous angioplasty in the management of patients with MS outside of rigorous clinical trials," the investigators concluded.

  Dr. Robert Zivadinov

The findings follow a recent Food and Drug Administration warning that PTVA (percutaneous transluminal venous angioplasty) can cause deaths and injuries, including strokes, damage to the treated vein, blood clots, cranial nerve damage, abdominal bleeding, and detachment and migration of stents.

The idea is to use balloon angioplasty and stents to widen veins in the chest and neck that appear to be narrowed in some MS patients. Proponents of the procedure say that those narrowed veins impair blood flow and lead to disease progression. The researchers who discovered the problem dubbed it CCSVI. A cottage industry has since sprung up to offer PTVA to MS patients.

The FDA noted in its warning that there have been no "controlled ... rigorously conducted, properly targeted" studies of the issue; that may have changed when Dr. Robert Zivadinov, a professor in the department of neurology at SUNY-Buffalo, presented his team’s findings at the annual meeting of the American Academy of Neurology.

"When you reopened those veins in the neck, I think something happened in reperfusing the brain and re-exacerbating disease activity. The message of this is clear. The majority of patients who are relapsing-remitting should not undergo this treatment," he said in an interview.

Ten patients got PTVA in the first phase of the study. The second phase randomized 9 to PTVA and 10 to a sham intervention. Most had relapsing-remitting MS.

There were no MS relapses in the first phase, but PTVA patients had more relapses (4 vs. 1; P = .389) and more MRI disease activity (cumulative number of new contrast-enhancing lesions (19 vs. 3; P = .062) and new T2 lesions (17 vs. 3; P = .066) in the 6 months following treatment in phase II.

PTVA patients also didn’t fare any better on Expanded Disability Status Scale (EDSS) scores, Multiple Sclerosis Functional Composite scores, 6-minute walk tests, or measures of cognition and quality of life.

"We chose very active patients who had one relapse in the previous year or [gadolinium-] enhancing lesions in the 3 months before. The sample size is small, but [more than half] of patients in the treatment group showed increased activity," Dr. Zivadinov said.

The majority of the subjects were women. On average, they were about 45 years old, had been diagnosed with MS for 11 years, and were mildly to moderately disabled (mean EDSS score about 4). Most were on interferon, glatiramer acetate, or both.

Venous angioplasty didn’t cause any serious complications, and it restored venous outflow to at least 50% of normal in most patients. Phase I patients had a better than 75% improvement overall. Phase II patients had less benefit; there were no differences in venous hemodynamic insufficiency scores between treated and sham patients.

The treatment "failed to provide any sustained improvement in venous outflow as measured through duplex and/or clinical and MRI outcomes," and "more sizable changes in venous outflow [were] associated with increased disease activity primarily noted on MRI," Dr. Zivadinov and his colleagues concluded.

The work was funded primarily by SUNY-Buffalo’s Neuroimaging Analysis Center and Baird MS Research Center. Dr. Zivadinov receives personal compensation from Teva Pharmaceuticals, Biogen Idec, EMD Serono, Bayer, Genzyme-Sanofi, Novartis, Bracco Imaging, and Questcor Pharmaceuticals.

[email protected]

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Insulin resistance may predict ventilator-associated pneumonia

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LAS VEGAS – The development of euglycemic insulin resistance soon after intubation may herald the onset of ventilator-associated pneumonia, a study by investigators at Vanderbilt University in Nashville, Tenn., has shown.

Researchers compared 92 critically injured trauma patients who developed VAP (ventilator-associated pneumonia) 3-4 days after intubation with 2,162 who did not. All the subjects had their blood glucose levels kept mostly between 80 and 150 mg/dL with the help of a computer-assisted protocol that adjusted insulin drip rates as necessary, lead investigator Dr. Kaushik Mukherjee reported at the annual meeting of the Surgical Infection Society.

Dr. Kaushik Mukherjee

There were no differences in baseline demographics between the two groups, but compared with controls, patients who developed VAP needed significantly higher insulin drip rates to stay in that range the day before and the first and third days after they met clinical criteria for VAP diagnosis (maximum difference, 1.1 U/hr [95% CI, 0.8-1.5; P less than .001]).

The M multiplier, a surrogate for insulin resistance calculated from blood glucose levels and insulin drip rates, was significantly higher 2 days before VAP was diagnosed, and remained so for 10 days afterward.

If the findings hold up with further investigation, the Vanderbilt team believes they may one day help predict who’s at risk for VAP so that preventative measures can be taken. Among other things, the model will need to incorporate body mass index, steroid use, tube-feeding schedule, and other confounders that impact insulin requirements, and be put through a prospective trial.

Even so, "these data indicate euglycemic insulin resistance may be an important new indicator for VAP in the era of strict glycemic control. [This] may be valuable moving forward," said Dr. Mukherjee of Vanderbilt’s division of trauma and surgical critical care.

"We believe that critically injured patients with VAP show euglycemic insulin resistance as measured by the multiplier, and we think [that] could be predictive of infection. We are hoping to turn this into an insulin resistance–based screening tool for VAP that would help us decide when we should obtain a [bronchoalveolar lavage]. Earlier detection of pneumonias could result in earlier antibiotic therapy and survival," he said.

Patients in the study were at least 16 years old, and had been ventilated for at least 48 hours.

Both VAP and control patients needed increasing amounts of insulin in the 10 days following intubation, probably "due to added nutrition, but [the VAP group required] a more rapid increase in their insulin infusion rates" starting about 3 days before VAP was diagnosed.

Overall, VAP patients had lower blood glucose levels both before and after diagnosis and were less likely to exceed the target range. "We think it’s because their innate ability to control glucose [was more] impaired, [so] there was less variability from the patient’s own system," Dr. Mukherjee said.

He said he had no relevant financial disclosures.

[email protected]

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LAS VEGAS – The development of euglycemic insulin resistance soon after intubation may herald the onset of ventilator-associated pneumonia, a study by investigators at Vanderbilt University in Nashville, Tenn., has shown.

Researchers compared 92 critically injured trauma patients who developed VAP (ventilator-associated pneumonia) 3-4 days after intubation with 2,162 who did not. All the subjects had their blood glucose levels kept mostly between 80 and 150 mg/dL with the help of a computer-assisted protocol that adjusted insulin drip rates as necessary, lead investigator Dr. Kaushik Mukherjee reported at the annual meeting of the Surgical Infection Society.

Dr. Kaushik Mukherjee

There were no differences in baseline demographics between the two groups, but compared with controls, patients who developed VAP needed significantly higher insulin drip rates to stay in that range the day before and the first and third days after they met clinical criteria for VAP diagnosis (maximum difference, 1.1 U/hr [95% CI, 0.8-1.5; P less than .001]).

The M multiplier, a surrogate for insulin resistance calculated from blood glucose levels and insulin drip rates, was significantly higher 2 days before VAP was diagnosed, and remained so for 10 days afterward.

If the findings hold up with further investigation, the Vanderbilt team believes they may one day help predict who’s at risk for VAP so that preventative measures can be taken. Among other things, the model will need to incorporate body mass index, steroid use, tube-feeding schedule, and other confounders that impact insulin requirements, and be put through a prospective trial.

Even so, "these data indicate euglycemic insulin resistance may be an important new indicator for VAP in the era of strict glycemic control. [This] may be valuable moving forward," said Dr. Mukherjee of Vanderbilt’s division of trauma and surgical critical care.

"We believe that critically injured patients with VAP show euglycemic insulin resistance as measured by the multiplier, and we think [that] could be predictive of infection. We are hoping to turn this into an insulin resistance–based screening tool for VAP that would help us decide when we should obtain a [bronchoalveolar lavage]. Earlier detection of pneumonias could result in earlier antibiotic therapy and survival," he said.

Patients in the study were at least 16 years old, and had been ventilated for at least 48 hours.

Both VAP and control patients needed increasing amounts of insulin in the 10 days following intubation, probably "due to added nutrition, but [the VAP group required] a more rapid increase in their insulin infusion rates" starting about 3 days before VAP was diagnosed.

Overall, VAP patients had lower blood glucose levels both before and after diagnosis and were less likely to exceed the target range. "We think it’s because their innate ability to control glucose [was more] impaired, [so] there was less variability from the patient’s own system," Dr. Mukherjee said.

He said he had no relevant financial disclosures.

[email protected]

LAS VEGAS – The development of euglycemic insulin resistance soon after intubation may herald the onset of ventilator-associated pneumonia, a study by investigators at Vanderbilt University in Nashville, Tenn., has shown.

Researchers compared 92 critically injured trauma patients who developed VAP (ventilator-associated pneumonia) 3-4 days after intubation with 2,162 who did not. All the subjects had their blood glucose levels kept mostly between 80 and 150 mg/dL with the help of a computer-assisted protocol that adjusted insulin drip rates as necessary, lead investigator Dr. Kaushik Mukherjee reported at the annual meeting of the Surgical Infection Society.

Dr. Kaushik Mukherjee

There were no differences in baseline demographics between the two groups, but compared with controls, patients who developed VAP needed significantly higher insulin drip rates to stay in that range the day before and the first and third days after they met clinical criteria for VAP diagnosis (maximum difference, 1.1 U/hr [95% CI, 0.8-1.5; P less than .001]).

The M multiplier, a surrogate for insulin resistance calculated from blood glucose levels and insulin drip rates, was significantly higher 2 days before VAP was diagnosed, and remained so for 10 days afterward.

If the findings hold up with further investigation, the Vanderbilt team believes they may one day help predict who’s at risk for VAP so that preventative measures can be taken. Among other things, the model will need to incorporate body mass index, steroid use, tube-feeding schedule, and other confounders that impact insulin requirements, and be put through a prospective trial.

Even so, "these data indicate euglycemic insulin resistance may be an important new indicator for VAP in the era of strict glycemic control. [This] may be valuable moving forward," said Dr. Mukherjee of Vanderbilt’s division of trauma and surgical critical care.

"We believe that critically injured patients with VAP show euglycemic insulin resistance as measured by the multiplier, and we think [that] could be predictive of infection. We are hoping to turn this into an insulin resistance–based screening tool for VAP that would help us decide when we should obtain a [bronchoalveolar lavage]. Earlier detection of pneumonias could result in earlier antibiotic therapy and survival," he said.

Patients in the study were at least 16 years old, and had been ventilated for at least 48 hours.

Both VAP and control patients needed increasing amounts of insulin in the 10 days following intubation, probably "due to added nutrition, but [the VAP group required] a more rapid increase in their insulin infusion rates" starting about 3 days before VAP was diagnosed.

Overall, VAP patients had lower blood glucose levels both before and after diagnosis and were less likely to exceed the target range. "We think it’s because their innate ability to control glucose [was more] impaired, [so] there was less variability from the patient’s own system," Dr. Mukherjee said.

He said he had no relevant financial disclosures.

[email protected]

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Major finding: Ninety-two patients had a sharp increase in insulin requirements shortly before they were diagnosed with ventilator-associated pneumonia; 2,162 ventilated controls did not.

Data Source: A retrospective, single-center study.

Disclosures: The lead investigator reported having no relevant financial conflicts.

Plan B One-Step now OTC for women 15-16 years old

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Plan B One-Step can now be purchased without a prescription by young women aged 15-16 years so long as they can verify their age, the Food and Drug Administration announced April 30.

Previously, only women 17 years or older could purchase Teva’s one-dose levonorgestrel emergency contraceptive under those conditions; others needed a prescription.

Plan B One-Step (levonorgestrel tablet, 1.5 mg, for oral use) "will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product," according to the FDA announcement.

Plan B One-Step is now available for 15- and 16-year old women who can provide age verification with purchase.

The product will be available in the family planning or women’s health aisles of stores that have a pharmacy and will be accessible "whether the pharmacy is open or not," the statement continued.

The agency also said that this approval is unrelated to an April 5 U.S. District Court order that gave it 30 days to grant emergency contraception full OTC status.

Specifically, the court ordered the FDA "to grant a 2001 citizen’s petition ... that sought to allow over-the-counter access to Plan B [a two dose levonorgestrel product] for women of all ages and/or make Plan B One-Step available without age or point of sale restrictions," the agency said.

However, Teva had a pending application to market Plan B One-Step to women 15 years and older prior to the ruling. According to the FDA, approval of the Plan B One-Step "is independent of that litigation and this decision is not intended to address the judge’s ruling. The Department of Justice is considering next steps in the litigation. In the meantime, the FDA took independent action to approve the pending application on Plan B One-Step."

The Center for Reproductive Rights, a plaintiff to the lawsuit that led to the ruling, said in a statement that "lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women, but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification or after the pharmacy gates have been closed for the night or weekend."

Planned Parenthood noted in its statement, "While we fully support this expansion of access to birth control, we continue to believe that the administration should lift all unnecessary restrictions to emergency contraception, consistent with the prevailing science and medicine."

"We really would like no age restriction," said spokeswoman Kristen Glundberg-Prossor. "If you really need [emergency contraception], you need to have easy access to it. Anytime you have these age restrictions on a drug, they create a lot of confusion."

The confusion could get worse since Plan B One-Step and the original Plan B now have different age requirements for OTC access, in addition to different dosing schedules despite similar-sounding names. The original product remains indicated without a prescription for women aged 17 years or older.

Meanwhile, it’s unknown if the Department of Health and Human Services will contest the court ruling, and there’s a third emergency contraceptive, Ella, that is available only by prescription.

"Confusion usually winds up reducing access" as pharmacists, unsure of the rules, err on the side of caution, said Dr. Eve Espey, associate professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.

But it’s important to remember that, overall, "access to emergency contraception is being liberalized and hopefully will continue to get easier for women. Talking to women about emergency contraception and continuing to advocate for increased access [both] remain really important," she said.

Teva plans an education campaign to bring consumers, pharmacy staff, and health care providers up to speed with Plan B One-Step’s new age rules, the FDA said.

Dr. Espey said that she had no financial conflicts of interest.

[email protected]

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Plan B One-Step can now be purchased without a prescription by young women aged 15-16 years so long as they can verify their age, the Food and Drug Administration announced April 30.

Previously, only women 17 years or older could purchase Teva’s one-dose levonorgestrel emergency contraceptive under those conditions; others needed a prescription.

Plan B One-Step (levonorgestrel tablet, 1.5 mg, for oral use) "will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product," according to the FDA announcement.

Plan B One-Step is now available for 15- and 16-year old women who can provide age verification with purchase.

The product will be available in the family planning or women’s health aisles of stores that have a pharmacy and will be accessible "whether the pharmacy is open or not," the statement continued.

The agency also said that this approval is unrelated to an April 5 U.S. District Court order that gave it 30 days to grant emergency contraception full OTC status.

Specifically, the court ordered the FDA "to grant a 2001 citizen’s petition ... that sought to allow over-the-counter access to Plan B [a two dose levonorgestrel product] for women of all ages and/or make Plan B One-Step available without age or point of sale restrictions," the agency said.

However, Teva had a pending application to market Plan B One-Step to women 15 years and older prior to the ruling. According to the FDA, approval of the Plan B One-Step "is independent of that litigation and this decision is not intended to address the judge’s ruling. The Department of Justice is considering next steps in the litigation. In the meantime, the FDA took independent action to approve the pending application on Plan B One-Step."

The Center for Reproductive Rights, a plaintiff to the lawsuit that led to the ruling, said in a statement that "lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women, but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification or after the pharmacy gates have been closed for the night or weekend."

Planned Parenthood noted in its statement, "While we fully support this expansion of access to birth control, we continue to believe that the administration should lift all unnecessary restrictions to emergency contraception, consistent with the prevailing science and medicine."

"We really would like no age restriction," said spokeswoman Kristen Glundberg-Prossor. "If you really need [emergency contraception], you need to have easy access to it. Anytime you have these age restrictions on a drug, they create a lot of confusion."

The confusion could get worse since Plan B One-Step and the original Plan B now have different age requirements for OTC access, in addition to different dosing schedules despite similar-sounding names. The original product remains indicated without a prescription for women aged 17 years or older.

Meanwhile, it’s unknown if the Department of Health and Human Services will contest the court ruling, and there’s a third emergency contraceptive, Ella, that is available only by prescription.

"Confusion usually winds up reducing access" as pharmacists, unsure of the rules, err on the side of caution, said Dr. Eve Espey, associate professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.

But it’s important to remember that, overall, "access to emergency contraception is being liberalized and hopefully will continue to get easier for women. Talking to women about emergency contraception and continuing to advocate for increased access [both] remain really important," she said.

Teva plans an education campaign to bring consumers, pharmacy staff, and health care providers up to speed with Plan B One-Step’s new age rules, the FDA said.

Dr. Espey said that she had no financial conflicts of interest.

[email protected]

Plan B One-Step can now be purchased without a prescription by young women aged 15-16 years so long as they can verify their age, the Food and Drug Administration announced April 30.

Previously, only women 17 years or older could purchase Teva’s one-dose levonorgestrel emergency contraceptive under those conditions; others needed a prescription.

Plan B One-Step (levonorgestrel tablet, 1.5 mg, for oral use) "will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product," according to the FDA announcement.

Plan B One-Step is now available for 15- and 16-year old women who can provide age verification with purchase.

The product will be available in the family planning or women’s health aisles of stores that have a pharmacy and will be accessible "whether the pharmacy is open or not," the statement continued.

The agency also said that this approval is unrelated to an April 5 U.S. District Court order that gave it 30 days to grant emergency contraception full OTC status.

Specifically, the court ordered the FDA "to grant a 2001 citizen’s petition ... that sought to allow over-the-counter access to Plan B [a two dose levonorgestrel product] for women of all ages and/or make Plan B One-Step available without age or point of sale restrictions," the agency said.

However, Teva had a pending application to market Plan B One-Step to women 15 years and older prior to the ruling. According to the FDA, approval of the Plan B One-Step "is independent of that litigation and this decision is not intended to address the judge’s ruling. The Department of Justice is considering next steps in the litigation. In the meantime, the FDA took independent action to approve the pending application on Plan B One-Step."

The Center for Reproductive Rights, a plaintiff to the lawsuit that led to the ruling, said in a statement that "lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women, but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification or after the pharmacy gates have been closed for the night or weekend."

Planned Parenthood noted in its statement, "While we fully support this expansion of access to birth control, we continue to believe that the administration should lift all unnecessary restrictions to emergency contraception, consistent with the prevailing science and medicine."

"We really would like no age restriction," said spokeswoman Kristen Glundberg-Prossor. "If you really need [emergency contraception], you need to have easy access to it. Anytime you have these age restrictions on a drug, they create a lot of confusion."

The confusion could get worse since Plan B One-Step and the original Plan B now have different age requirements for OTC access, in addition to different dosing schedules despite similar-sounding names. The original product remains indicated without a prescription for women aged 17 years or older.

Meanwhile, it’s unknown if the Department of Health and Human Services will contest the court ruling, and there’s a third emergency contraceptive, Ella, that is available only by prescription.

"Confusion usually winds up reducing access" as pharmacists, unsure of the rules, err on the side of caution, said Dr. Eve Espey, associate professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.

But it’s important to remember that, overall, "access to emergency contraception is being liberalized and hopefully will continue to get easier for women. Talking to women about emergency contraception and continuing to advocate for increased access [both] remain really important," she said.

Teva plans an education campaign to bring consumers, pharmacy staff, and health care providers up to speed with Plan B One-Step’s new age rules, the FDA said.

Dr. Espey said that she had no financial conflicts of interest.

[email protected]

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Plan B One-Step now OTC for women 15-16 years old
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Plan B One-Step now OTC for women 15-16 years old
Legacy Keywords
Plan B One-Step, Food and Drug Administration, FDA, levonorgestrel, emergency contraceptive, Plan B, birth control, morning-after pill
Legacy Keywords
Plan B One-Step, Food and Drug Administration, FDA, levonorgestrel, emergency contraceptive, Plan B, birth control, morning-after pill
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