Miriam E. Tucker

Major Finding: BMI failed to detect obesity in 37% and falsely detected it in 5% in a study of 1,234 adults who had both BMI and DXA measurements.

Data Source: Medical chart review of private adult outpatients.

Disclosures: Study funded by the PATH Research Foundation NY. Dr. Braverman, who is director of PATH medical centers in New York and Philadelphia, said he had no other financial disclosures.

BOSTON — Dual x-ray absorptiometry was a more accurate predictor of obesity than was body mass index in a retrospective comparison of the two measures in 1,234 adults.

Despite its widespread use, BMI is not an accurate indicator of body fat. Direct measures of adiposity, such as those obtained by dual x-ray absorptiometry (DXA), are far more precise, Dr. Eric R. Braverman and his associates reported in a poster at the meeting.”

“We have a big problem with the BMI. You could retitle it the 'baloney mass index.' It's a mathematical equation. … The scientific standard is clearly subpar compared to our other endocrinology standards,” Dr. Braverman of the department of neurological surgery at Weill Cornell Medical College, New York, said at a press briefing.

Medical records of 1,234 private adult outpatients (490 men, 744 women) who had both BMI and DXA measurements during 2003-2009 were analyzed. They had a mean age of 51 years, a mean BMI of 26.2 kg/m

Using BMI, 249 (20%) were classified as obese. DXA measurement showed that of those 249, 95% (237) were obese and 5% (12) were nonobese on the basis of body fat percentage.

Using DXA, 689 (56%) were classified as obese. Of those 689, 34% (237) were obese and 66% (452) were not obese based on BMI.

Thus, 37% of patients were misclassified by BMI: 452 were found to be obese by DXA but nonobese by BMI and 12 were obese by BMI but not by DXA. The 66% of patients classified as obese by DXA but who were “missed” by BMI had lower muscle and lean body mass, Dr. Braverman and his associates noted.

The BMI measurement of obesity in this study was approximately identical to the national percentage of obesity, which is also determined by BMI. “However, we have shown that BMI is a highly insensitive measure, resulting in an underdiagnosis of obesity. If we can extrapolate from the rest of our data on the national scale, it is very likely that obesity is a much bigger epidemic than is currently acknowledged,” the investigators said in the poster.

Dr. Braverman, who is also director of the Place for Achieving Total Health (PATH) medical centers, New York and Philadelphia, said in an interview that he foresees DXA becoming a routine part of clinical practice in the future, to measure bone density as well as assess obesity. “In the 21st century, the physical is really quite outdated and almost no yield to silent disease that every endocrinologist works in. DXA and an efficiency system that can deliver it at $3 a test will make it simply a part of the physical.

Major Finding: BMI failed to detect obesity in 37% and falsely detected it in 5% in a study of 1,234 adults who had both BMI and DXA measurements.

Data Source: Medical chart review of private adult outpatients.

Disclosures: Study funded by the PATH Research Foundation NY. Dr. Braverman, who is director of PATH medical centers in New York and Philadelphia, said he had no other financial disclosures.

BOSTON — Dual x-ray absorptiometry was a more accurate predictor of obesity than was body mass index in a retrospective comparison of the two measures in 1,234 adults.

Despite its widespread use, BMI is not an accurate indicator of body fat. Direct measures of adiposity, such as those obtained by dual x-ray absorptiometry (DXA), are far more precise, Dr. Eric R. Braverman and his associates reported in a poster at the meeting.”

“We have a big problem with the BMI. You could retitle it the 'baloney mass index.' It's a mathematical equation. … The scientific standard is clearly subpar compared to our other endocrinology standards,” Dr. Braverman of the department of neurological surgery at Weill Cornell Medical College, New York, said at a press briefing.

Medical records of 1,234 private adult outpatients (490 men, 744 women) who had both BMI and DXA measurements during 2003-2009 were analyzed. They had a mean age of 51 years, a mean BMI of 26.2 kg/m

Using BMI, 249 (20%) were classified as obese. DXA measurement showed that of those 249, 95% (237) were obese and 5% (12) were nonobese on the basis of body fat percentage.

Using DXA, 689 (56%) were classified as obese. Of those 689, 34% (237) were obese and 66% (452) were not obese based on BMI.

Thus, 37% of patients were misclassified by BMI: 452 were found to be obese by DXA but nonobese by BMI and 12 were obese by BMI but not by DXA. The 66% of patients classified as obese by DXA but who were “missed” by BMI had lower muscle and lean body mass, Dr. Braverman and his associates noted.

The BMI measurement of obesity in this study was approximately identical to the national percentage of obesity, which is also determined by BMI. “However, we have shown that BMI is a highly insensitive measure, resulting in an underdiagnosis of obesity. If we can extrapolate from the rest of our data on the national scale, it is very likely that obesity is a much bigger epidemic than is currently acknowledged,” the investigators said in the poster.

Dr. Braverman, who is also director of the Place for Achieving Total Health (PATH) medical centers, New York and Philadelphia, said in an interview that he foresees DXA becoming a routine part of clinical practice in the future, to measure bone density as well as assess obesity. “In the 21st century, the physical is really quite outdated and almost no yield to silent disease that every endocrinologist works in. DXA and an efficiency system that can deliver it at $3 a test will make it simply a part of the physical.

Major Finding: BMI failed to detect obesity in 37% and falsely detected it in 5% in a study of 1,234 adults who had both BMI and DXA measurements.

Data Source: Medical chart review of private adult outpatients.

Disclosures: Study funded by the PATH Research Foundation NY. Dr. Braverman, who is director of PATH medical centers in New York and Philadelphia, said he had no other financial disclosures.

BOSTON — Dual x-ray absorptiometry was a more accurate predictor of obesity than was body mass index in a retrospective comparison of the two measures in 1,234 adults.

Despite its widespread use, BMI is not an accurate indicator of body fat. Direct measures of adiposity, such as those obtained by dual x-ray absorptiometry (DXA), are far more precise, Dr. Eric R. Braverman and his associates reported in a poster at the meeting.”

“We have a big problem with the BMI. You could retitle it the 'baloney mass index.' It's a mathematical equation. … The scientific standard is clearly subpar compared to our other endocrinology standards,” Dr. Braverman of the department of neurological surgery at Weill Cornell Medical College, New York, said at a press briefing.

Medical records of 1,234 private adult outpatients (490 men, 744 women) who had both BMI and DXA measurements during 2003-2009 were analyzed. They had a mean age of 51 years, a mean BMI of 26.2 kg/m

Using BMI, 249 (20%) were classified as obese. DXA measurement showed that of those 249, 95% (237) were obese and 5% (12) were nonobese on the basis of body fat percentage.

Using DXA, 689 (56%) were classified as obese. Of those 689, 34% (237) were obese and 66% (452) were not obese based on BMI.

Thus, 37% of patients were misclassified by BMI: 452 were found to be obese by DXA but nonobese by BMI and 12 were obese by BMI but not by DXA. The 66% of patients classified as obese by DXA but who were “missed” by BMI had lower muscle and lean body mass, Dr. Braverman and his associates noted.

The BMI measurement of obesity in this study was approximately identical to the national percentage of obesity, which is also determined by BMI. “However, we have shown that BMI is a highly insensitive measure, resulting in an underdiagnosis of obesity. If we can extrapolate from the rest of our data on the national scale, it is very likely that obesity is a much bigger epidemic than is currently acknowledged,” the investigators said in the poster.

Dr. Braverman, who is also director of the Place for Achieving Total Health (PATH) medical centers, New York and Philadelphia, said in an interview that he foresees DXA becoming a routine part of clinical practice in the future, to measure bone density as well as assess obesity. “In the 21st century, the physical is really quite outdated and almost no yield to silent disease that every endocrinologist works in. DXA and an efficiency system that can deliver it at $3 a test will make it simply a part of the physical.

Major Finding: High spinal block occurred with 1 of every 4,300 regional anesthetics. Other anesthesia-related serious complications were far less common, including respiratory distress during labor and delivery in 1 in 10,000, unrecognized spinal catheter in 1 in 15,000, and severe neurologic injury in 1 in 36,000.

Data Source: The Society for Obstetric Anesthesia and Perinatology Serious Complication Repository.

Disclosures: None was reported.

SAN ANTONIO — Serious obstetric complications occur in approximately 1 in 1,900 deliveries and serious anesthesia-related complications in about 1 in 3,000, according to data from a large multisite repository.

The Society for Obstetric Anesthesia and Perinatology Serious Complication Repository (SOAP SCORE) project was established in 2004 with the aim of gathering accurate data on the incidence of both overall obstetric- and obstetric anesthesia–related complications, as well as additional information about the complications that could inform future obstetric anesthesia practice.

Until now, complication rates reported in the literature have varied dramatically. “From this database, we can tell you that the rate of serious anesthesia-related obstetric complications is very low,” said Dr. Robert D'Angelo, professor of anesthesiology at Wake Forest University, Winston-Salem, N.C.

Data were collected on a quarterly basis from 25 institutions between Oct. 1, 2004, and June 30, 2009. Of a total 307,500 deliveries, approximately 257,000 (84%) involved anesthesia and 96,000 were cesarean sections. Regional anesthesia was used in about 76% of the vaginal deliveries and in 69% of the C-sections. There were a total of 158 serious complications, for a rate of 1 in 1,900 deliveries. Of those, 84 were deemed to be related to anesthesia, for a rate of 1 in 3,000. Failed regional anesthesia occurred in 1.7%.

Failed intubation occurred with 1 of every 533 general anesthetics, and high spinal block in 1 of every 4,300 regional anesthetics. Other anesthesia-related serious complications were far less common, including respiratory distress during labor and delivery in 1 in 10,000, unrecognized spinal catheter in 1 in 15,000, and severe neurologic injury in 1 in 36,000. The rate of epidural abscess/meningitis related to anesthesia was 1 in 63,000, while the rates of anesthesia-related myocardial infarction and cardiac arrest were both just 1 in 128,000. Rarest of all was epidural hematoma, in 1 in 250,000.

There were 30 maternal deaths and 5 cases of anaphylaxis, but none was deemed to be anesthesia related. There were no aspirations, Dr. D'Angelo said.

High spinal block was the only anesthesia-related complication reported in large enough numbers to allow for generalizations regarding associated risk factors. Of the 58 high spinal blocks reported, 14 were the result of an unrecognized spinal catheter. Of the remaining 44, known risk factors were identified in 32. The most common of these were obesity and spinal anesthesia following failed epidural.

Data were also collected on postdural puncture headaches (PDPH). Of the 1,647 reported PDPH, 917 (56%) were treated with epidural blood patch, and 98 (11% of EBP) required a repeat blood patch.

In October 2008, the American Society of Anesthesiologists formed the Anesthesia Quality Institute (www.aqihq.org

They plan to publish their first set of findings by January 2011, Dr. D'Angelo said in an interview.

'The rate of serious anesthesia-related obstetric complications is very low.'

Source DR. D'ANGELO

Major Finding: High spinal block occurred with 1 of every 4,300 regional anesthetics. Other anesthesia-related serious complications were far less common, including respiratory distress during labor and delivery in 1 in 10,000, unrecognized spinal catheter in 1 in 15,000, and severe neurologic injury in 1 in 36,000.

Data Source: The Society for Obstetric Anesthesia and Perinatology Serious Complication Repository.

Disclosures: None was reported.

SAN ANTONIO — Serious obstetric complications occur in approximately 1 in 1,900 deliveries and serious anesthesia-related complications in about 1 in 3,000, according to data from a large multisite repository.

The Society for Obstetric Anesthesia and Perinatology Serious Complication Repository (SOAP SCORE) project was established in 2004 with the aim of gathering accurate data on the incidence of both overall obstetric- and obstetric anesthesia–related complications, as well as additional information about the complications that could inform future obstetric anesthesia practice.

Until now, complication rates reported in the literature have varied dramatically. “From this database, we can tell you that the rate of serious anesthesia-related obstetric complications is very low,” said Dr. Robert D'Angelo, professor of anesthesiology at Wake Forest University, Winston-Salem, N.C.

Data were collected on a quarterly basis from 25 institutions between Oct. 1, 2004, and June 30, 2009. Of a total 307,500 deliveries, approximately 257,000 (84%) involved anesthesia and 96,000 were cesarean sections. Regional anesthesia was used in about 76% of the vaginal deliveries and in 69% of the C-sections. There were a total of 158 serious complications, for a rate of 1 in 1,900 deliveries. Of those, 84 were deemed to be related to anesthesia, for a rate of 1 in 3,000. Failed regional anesthesia occurred in 1.7%.

Failed intubation occurred with 1 of every 533 general anesthetics, and high spinal block in 1 of every 4,300 regional anesthetics. Other anesthesia-related serious complications were far less common, including respiratory distress during labor and delivery in 1 in 10,000, unrecognized spinal catheter in 1 in 15,000, and severe neurologic injury in 1 in 36,000. The rate of epidural abscess/meningitis related to anesthesia was 1 in 63,000, while the rates of anesthesia-related myocardial infarction and cardiac arrest were both just 1 in 128,000. Rarest of all was epidural hematoma, in 1 in 250,000.

There were 30 maternal deaths and 5 cases of anaphylaxis, but none was deemed to be anesthesia related. There were no aspirations, Dr. D'Angelo said.

High spinal block was the only anesthesia-related complication reported in large enough numbers to allow for generalizations regarding associated risk factors. Of the 58 high spinal blocks reported, 14 were the result of an unrecognized spinal catheter. Of the remaining 44, known risk factors were identified in 32. The most common of these were obesity and spinal anesthesia following failed epidural.

Data were also collected on postdural puncture headaches (PDPH). Of the 1,647 reported PDPH, 917 (56%) were treated with epidural blood patch, and 98 (11% of EBP) required a repeat blood patch.

In October 2008, the American Society of Anesthesiologists formed the Anesthesia Quality Institute (www.aqihq.org

They plan to publish their first set of findings by January 2011, Dr. D'Angelo said in an interview.

'The rate of serious anesthesia-related obstetric complications is very low.'

Source DR. D'ANGELO

Major Finding: High spinal block occurred with 1 of every 4,300 regional anesthetics. Other anesthesia-related serious complications were far less common, including respiratory distress during labor and delivery in 1 in 10,000, unrecognized spinal catheter in 1 in 15,000, and severe neurologic injury in 1 in 36,000.

Data Source: The Society for Obstetric Anesthesia and Perinatology Serious Complication Repository.

Disclosures: None was reported.

SAN ANTONIO — Serious obstetric complications occur in approximately 1 in 1,900 deliveries and serious anesthesia-related complications in about 1 in 3,000, according to data from a large multisite repository.

The Society for Obstetric Anesthesia and Perinatology Serious Complication Repository (SOAP SCORE) project was established in 2004 with the aim of gathering accurate data on the incidence of both overall obstetric- and obstetric anesthesia–related complications, as well as additional information about the complications that could inform future obstetric anesthesia practice.

Until now, complication rates reported in the literature have varied dramatically. “From this database, we can tell you that the rate of serious anesthesia-related obstetric complications is very low,” said Dr. Robert D'Angelo, professor of anesthesiology at Wake Forest University, Winston-Salem, N.C.

Data were collected on a quarterly basis from 25 institutions between Oct. 1, 2004, and June 30, 2009. Of a total 307,500 deliveries, approximately 257,000 (84%) involved anesthesia and 96,000 were cesarean sections. Regional anesthesia was used in about 76% of the vaginal deliveries and in 69% of the C-sections. There were a total of 158 serious complications, for a rate of 1 in 1,900 deliveries. Of those, 84 were deemed to be related to anesthesia, for a rate of 1 in 3,000. Failed regional anesthesia occurred in 1.7%.

Failed intubation occurred with 1 of every 533 general anesthetics, and high spinal block in 1 of every 4,300 regional anesthetics. Other anesthesia-related serious complications were far less common, including respiratory distress during labor and delivery in 1 in 10,000, unrecognized spinal catheter in 1 in 15,000, and severe neurologic injury in 1 in 36,000. The rate of epidural abscess/meningitis related to anesthesia was 1 in 63,000, while the rates of anesthesia-related myocardial infarction and cardiac arrest were both just 1 in 128,000. Rarest of all was epidural hematoma, in 1 in 250,000.

There were 30 maternal deaths and 5 cases of anaphylaxis, but none was deemed to be anesthesia related. There were no aspirations, Dr. D'Angelo said.

High spinal block was the only anesthesia-related complication reported in large enough numbers to allow for generalizations regarding associated risk factors. Of the 58 high spinal blocks reported, 14 were the result of an unrecognized spinal catheter. Of the remaining 44, known risk factors were identified in 32. The most common of these were obesity and spinal anesthesia following failed epidural.

Data were also collected on postdural puncture headaches (PDPH). Of the 1,647 reported PDPH, 917 (56%) were treated with epidural blood patch, and 98 (11% of EBP) required a repeat blood patch.

In October 2008, the American Society of Anesthesiologists formed the Anesthesia Quality Institute (www.aqihq.org

They plan to publish their first set of findings by January 2011, Dr. D'Angelo said in an interview.

'The rate of serious anesthesia-related obstetric complications is very low.'

Source DR. D'ANGELO

Major Finding: Fourteen cases of failed spinal anesthesia were attributed to chemical alteration from cold temperature exposure.

Data Source: Experience at Magee-Women's Hospital, Pittsburgh.

Disclosures: None was reported.

SAN ANTONIO — A cluster of 14 cases of failed spinal anesthesia among women undergoing C-sections in Pittsburgh during the winter of 2008-2009 was linked to chemical alteration that is believed to be the result of exposure of the anesthetic to subfreezing temperatures during the shipping process.

Failed spinal anesthesia can have significant clinical consequences, possibly necessitating redosing, conversion to general anesthesia, or pain during surgery.

“Efforts to identify and reduce the incidence of failed neuraxial anesthesia are of utmost importance, considering the increased use of these techniques in obstetric cases,” Dr. Manuel C. Vallejo Jr. said at the meeting.

The 14 cases, spanning an 8-week period, were all associated with three particular lots of unexpired BD spinal anesthesia trays. The cases were all under the care of experienced staff anesthesiologists and were associated with standardized neuraxial technique using hyperbaric bupivacaine 12 mg (0.75% with dextrose 8.25%) plus 20 mcg fentanyl plus 0.2 mg Duramorph (morphine). A 25-gauge Whitacre needle was used, and the free flow of cerebrospinal fluid was confirmed before and after the intrathecal drug placement, Dr. Vallejo reported.

His team at Magee-Women's Hospital contacted the bupivacaine manufacturer, Hospira Inc.; the spinal kit manufacturer, BD (Becton, Dickinson, and Co.); and the Food and Drug Administration, noting that the clustering of failures suggested problems with concentration/formulation or drug stability. Hospira tested samples from the drug lot and found no formulation or concentration issues.

For its part, BD replied that Hospira's testing showed that “all testing was within specification,” and that “we were unable to find the cause of the insufficient anesthesia identified in your report.”

The company also said that the drug supplier would “continue to monitor for the complaint condition through normal inspection and sampling procedures.”

The negative batch analysis, normal product potency, and unremarkable testing of retained samples by Hospira led Dr. Vallejo and his team to suspect that the problem was related to drug stability issues in transit and/or storage of the spinal kit.

There had been a cold spell starting during the first week of December, during which the temperature was never above freezing, ranging from 15.4° to 30.9° F.

The bupivacaine is made in Indianapolis by Hospira and is shipped to BD in New Jersey, where the spinal kits are assembled. The suspect kits had been shipped to a warehouse in Pittsburgh, loaded onto a nonenvironmentally controlled truck in the evening, and unloaded at Magee the following morning, thus having been stored for more than 9 hours at temperatures below freezing before delivery, Dr. Vallejo said.

A mass spectrometric analysis done at the University of Pittsburgh demonstrated that there had been chemical alteration of the bupivacaine involved. The suspect sample had a molecular mass to charge ratio of 276, compared with 289 for normal bupivacaine.

As a temporary solution, a separate bupivacaine ampule was affixed to the suspect spinal kits, and temperature indicator strips were used.

All 14 of the women and newborns were fine with no long-term problems, he noted.

BD now directly drop ships the packaged spinal kits to Magee-Women's. These measures have dramatically decreased but not eliminated the rate of failed spinal anesthetics, Dr. Vallejo commented, adding that other factors may also contribute, including technical failure, inadequate patient position, inadvertent subdural or epidural injection, inadequate intrathecal dose, and “rachi-resistance,” a phenomenon described in 1934 in which patients are “hyperresistant” to spinal anesthesia, possibly because of insensitive nerve roots.

“I think it's multifactorial, but we definitely showed a chemical alteration,” he noted.

During the question and answer period, an audience member from Toronto said that approximately 400 cases of failed spinal anesthesia had been reported in the province of Ontario in October 2009 and were also suspected to be a result of cold temperature exposure.

“There's definitely a problem,” Dr. Vallejo replied.

Asked to comment specifically for this story, BD replied in part: “Patient safety and quality of our products are BD's foremost priorities. The causes of failed regional anesthesia are multifactorial and an industrywide phenomenon. They are typically not associated with any single manufacturer's product.”

“Evaluations of our complaint records do not show a correlation between the shipment of product during cold or hot months and complaint rates. The rate remains stable across the year.

“We are conducting a more extensive, controlled study to evaluate this hypothesis. When this investigation is completed, BD will take all actions deemed necessary and appropriate by the study, if any.”

Major Finding: Fourteen cases of failed spinal anesthesia were attributed to chemical alteration from cold temperature exposure.

Data Source: Experience at Magee-Women's Hospital, Pittsburgh.

Disclosures: None was reported.

SAN ANTONIO — A cluster of 14 cases of failed spinal anesthesia among women undergoing C-sections in Pittsburgh during the winter of 2008-2009 was linked to chemical alteration that is believed to be the result of exposure of the anesthetic to subfreezing temperatures during the shipping process.

Failed spinal anesthesia can have significant clinical consequences, possibly necessitating redosing, conversion to general anesthesia, or pain during surgery.

“Efforts to identify and reduce the incidence of failed neuraxial anesthesia are of utmost importance, considering the increased use of these techniques in obstetric cases,” Dr. Manuel C. Vallejo Jr. said at the meeting.

The 14 cases, spanning an 8-week period, were all associated with three particular lots of unexpired BD spinal anesthesia trays. The cases were all under the care of experienced staff anesthesiologists and were associated with standardized neuraxial technique using hyperbaric bupivacaine 12 mg (0.75% with dextrose 8.25%) plus 20 mcg fentanyl plus 0.2 mg Duramorph (morphine). A 25-gauge Whitacre needle was used, and the free flow of cerebrospinal fluid was confirmed before and after the intrathecal drug placement, Dr. Vallejo reported.

His team at Magee-Women's Hospital contacted the bupivacaine manufacturer, Hospira Inc.; the spinal kit manufacturer, BD (Becton, Dickinson, and Co.); and the Food and Drug Administration, noting that the clustering of failures suggested problems with concentration/formulation or drug stability. Hospira tested samples from the drug lot and found no formulation or concentration issues.

For its part, BD replied that Hospira's testing showed that “all testing was within specification,” and that “we were unable to find the cause of the insufficient anesthesia identified in your report.”

The company also said that the drug supplier would “continue to monitor for the complaint condition through normal inspection and sampling procedures.”

The negative batch analysis, normal product potency, and unremarkable testing of retained samples by Hospira led Dr. Vallejo and his team to suspect that the problem was related to drug stability issues in transit and/or storage of the spinal kit.

There had been a cold spell starting during the first week of December, during which the temperature was never above freezing, ranging from 15.4° to 30.9° F.

The bupivacaine is made in Indianapolis by Hospira and is shipped to BD in New Jersey, where the spinal kits are assembled. The suspect kits had been shipped to a warehouse in Pittsburgh, loaded onto a nonenvironmentally controlled truck in the evening, and unloaded at Magee the following morning, thus having been stored for more than 9 hours at temperatures below freezing before delivery, Dr. Vallejo said.

A mass spectrometric analysis done at the University of Pittsburgh demonstrated that there had been chemical alteration of the bupivacaine involved. The suspect sample had a molecular mass to charge ratio of 276, compared with 289 for normal bupivacaine.

As a temporary solution, a separate bupivacaine ampule was affixed to the suspect spinal kits, and temperature indicator strips were used.

All 14 of the women and newborns were fine with no long-term problems, he noted.

BD now directly drop ships the packaged spinal kits to Magee-Women's. These measures have dramatically decreased but not eliminated the rate of failed spinal anesthetics, Dr. Vallejo commented, adding that other factors may also contribute, including technical failure, inadequate patient position, inadvertent subdural or epidural injection, inadequate intrathecal dose, and “rachi-resistance,” a phenomenon described in 1934 in which patients are “hyperresistant” to spinal anesthesia, possibly because of insensitive nerve roots.

“I think it's multifactorial, but we definitely showed a chemical alteration,” he noted.

During the question and answer period, an audience member from Toronto said that approximately 400 cases of failed spinal anesthesia had been reported in the province of Ontario in October 2009 and were also suspected to be a result of cold temperature exposure.

“There's definitely a problem,” Dr. Vallejo replied.

Asked to comment specifically for this story, BD replied in part: “Patient safety and quality of our products are BD's foremost priorities. The causes of failed regional anesthesia are multifactorial and an industrywide phenomenon. They are typically not associated with any single manufacturer's product.”

“Evaluations of our complaint records do not show a correlation between the shipment of product during cold or hot months and complaint rates. The rate remains stable across the year.

“We are conducting a more extensive, controlled study to evaluate this hypothesis. When this investigation is completed, BD will take all actions deemed necessary and appropriate by the study, if any.”

Major Finding: Fourteen cases of failed spinal anesthesia were attributed to chemical alteration from cold temperature exposure.

Data Source: Experience at Magee-Women's Hospital, Pittsburgh.

Disclosures: None was reported.

SAN ANTONIO — A cluster of 14 cases of failed spinal anesthesia among women undergoing C-sections in Pittsburgh during the winter of 2008-2009 was linked to chemical alteration that is believed to be the result of exposure of the anesthetic to subfreezing temperatures during the shipping process.

Failed spinal anesthesia can have significant clinical consequences, possibly necessitating redosing, conversion to general anesthesia, or pain during surgery.

“Efforts to identify and reduce the incidence of failed neuraxial anesthesia are of utmost importance, considering the increased use of these techniques in obstetric cases,” Dr. Manuel C. Vallejo Jr. said at the meeting.

The 14 cases, spanning an 8-week period, were all associated with three particular lots of unexpired BD spinal anesthesia trays. The cases were all under the care of experienced staff anesthesiologists and were associated with standardized neuraxial technique using hyperbaric bupivacaine 12 mg (0.75% with dextrose 8.25%) plus 20 mcg fentanyl plus 0.2 mg Duramorph (morphine). A 25-gauge Whitacre needle was used, and the free flow of cerebrospinal fluid was confirmed before and after the intrathecal drug placement, Dr. Vallejo reported.

His team at Magee-Women's Hospital contacted the bupivacaine manufacturer, Hospira Inc.; the spinal kit manufacturer, BD (Becton, Dickinson, and Co.); and the Food and Drug Administration, noting that the clustering of failures suggested problems with concentration/formulation or drug stability. Hospira tested samples from the drug lot and found no formulation or concentration issues.

For its part, BD replied that Hospira's testing showed that “all testing was within specification,” and that “we were unable to find the cause of the insufficient anesthesia identified in your report.”

The company also said that the drug supplier would “continue to monitor for the complaint condition through normal inspection and sampling procedures.”

The negative batch analysis, normal product potency, and unremarkable testing of retained samples by Hospira led Dr. Vallejo and his team to suspect that the problem was related to drug stability issues in transit and/or storage of the spinal kit.

There had been a cold spell starting during the first week of December, during which the temperature was never above freezing, ranging from 15.4° to 30.9° F.

The bupivacaine is made in Indianapolis by Hospira and is shipped to BD in New Jersey, where the spinal kits are assembled. The suspect kits had been shipped to a warehouse in Pittsburgh, loaded onto a nonenvironmentally controlled truck in the evening, and unloaded at Magee the following morning, thus having been stored for more than 9 hours at temperatures below freezing before delivery, Dr. Vallejo said.

A mass spectrometric analysis done at the University of Pittsburgh demonstrated that there had been chemical alteration of the bupivacaine involved. The suspect sample had a molecular mass to charge ratio of 276, compared with 289 for normal bupivacaine.

As a temporary solution, a separate bupivacaine ampule was affixed to the suspect spinal kits, and temperature indicator strips were used.

All 14 of the women and newborns were fine with no long-term problems, he noted.

BD now directly drop ships the packaged spinal kits to Magee-Women's. These measures have dramatically decreased but not eliminated the rate of failed spinal anesthetics, Dr. Vallejo commented, adding that other factors may also contribute, including technical failure, inadequate patient position, inadvertent subdural or epidural injection, inadequate intrathecal dose, and “rachi-resistance,” a phenomenon described in 1934 in which patients are “hyperresistant” to spinal anesthesia, possibly because of insensitive nerve roots.

“I think it's multifactorial, but we definitely showed a chemical alteration,” he noted.

During the question and answer period, an audience member from Toronto said that approximately 400 cases of failed spinal anesthesia had been reported in the province of Ontario in October 2009 and were also suspected to be a result of cold temperature exposure.

“There's definitely a problem,” Dr. Vallejo replied.

Asked to comment specifically for this story, BD replied in part: “Patient safety and quality of our products are BD's foremost priorities. The causes of failed regional anesthesia are multifactorial and an industrywide phenomenon. They are typically not associated with any single manufacturer's product.”

“Evaluations of our complaint records do not show a correlation between the shipment of product during cold or hot months and complaint rates. The rate remains stable across the year.

“We are conducting a more extensive, controlled study to evaluate this hypothesis. When this investigation is completed, BD will take all actions deemed necessary and appropriate by the study, if any.”

ROCKVILLE, MD. — Chronic back pain is an enormously heterogenous and common disorder that might better be examined in observational “Framingham-like studies” than in randomized, controlled clinical trials.

The recommendation was proposed by several presenters at the workshop sponsored by the National Center for Complementary and Alternative Medicine (NCCAM), a division of the National Institutes of Health.

“I think this is the right time to be talking about this problem. The NIH has certainly been urged by our leader, Dr. Francis Collins, to worry about research of relevance to health policy, and I can't think of a single issue that has as much resonance or potential implications for health policy as this one,” NCCAM director Josephine Briggs said.

Dr. Briggs also noted, “This is not my area, but as I've learned more about back pain over the last year, I have been absolutely blown away by the magnitude of this problem and the enormous clinical difficulties in bringing relief to most patients suffering from chronic back pain.… This is a totally pervasive, a huge driver of health costs, and frankly, I think a problem for which we only have a small number of satisfactory clinical solutions, so I think it's incredibly important that we talk about it.”

There was agreement among participants that chronic back pain is not simply a multifaceted biological problem, but also a psychosocial one. And as such, there is little correlation between physical findings on imaging or other studies and the degree to which a patient perceives pain or experiences functional impairment. Participants also generally agreed that current treatments, including opioids and surgical approaches, are ineffective in a large proportion of patients and have been associated with harm as well.

The extensive heterogeneity in causes, presentations, and functional impact of chronic back pain has made it impossible to compare studies on the problem and determine the extent to which results from any given study can be extrapolated to another, speakers agreed.

Indeed, even the most commonly used definition of “chronic”—pain lasting longer than 3 or 6 months—is limiting in that it doesn't account for other parameters such as pain intensity, associated psychological dysfunction, or degree of functional impairment, noted Michael Von Korff, Sc.D., senior investigator at Group Health Research Institute, Seattle.

He described an alternative “prognostic risk score” that would not only classify patients with back pain but would also help to determine their probability of future clinically significant back pain. The score, derived from a study of 1,213 primary care back pain patients, utilizes measurements of degrees of pain intensity, interference with activities, persistence, number of pain sites, and depression to define risk levels corresponding to a 50% and an 80% probability of future clinically significant pain (Pain 2005;117:304–13).

Such an “empirically grounded” approach, he said, could help distinguish patients at low risk who could be managed conservatively from those at greater risk for whom intervention could be initiated early, rather than waiting for the passage of time until they meet the “chronic” criteria. Moreover, “it avoids labeling patients as hopeless, with immutable back pain, when change for the better is always possible and often likely.”

William Maixner, D.D.S., Ph.D., professor and director of the Center for Neurosensory Disorders at the University of North Carolina School of Dentistry, Chapel Hill, said that a study he's heading in patients with temporomandibular joint (TMJ) disorders could also serve as a model for studying chronic back pain.

The 7-year Orofacial Pain: Prospective Evaluation and Risk Assessment (OPPERA), funded by the National Institute of Dental and Craniofacial Research (NIDCR), is the first-ever large, prospective clinical study in the field of chronic pain. Begun in 2005, it enrolled 3,276 initially pain-free adults, and is following them with the aim of identifying underlying pathophysiological, psychological, and genetic risk factors that predict who will go on to develop TMJ disorders.

Michele Crites Battié, Ph.D., of the University of Alberta, Edmonton, called into question whether the outcome measures that have been used so far in back pain studies are actually the most relevant and appropriate for ascertaining clinically meaningful treatment effects. For example, should studies assess mean changes in intervention versus control groups, or measure the difference in percent achieving a clinically meaningful threshold? And beyond that, is the data point being measured one that is meaningful to the patient?

Dr. Gary Franklin, a research professor in environmental and occupational health sciences at the University of Washington, Seattle, said the Food and Drug Administration uses only pain as a primary outcome measure for drug trials, with function and quality of life as secondary outcomes.

Several speakers questioned whether the randomized clinical trial, widely considered the “gold standard” type of study for the efficacy of drugs, is really the best type of trial to examine aspects of such a heterogenous problem as chronic back pain, and whether longitudinal observational “Framingham-like” study might be more appropriate to determine what happens to patients with chronic back pain over time.

In an interview, workshop cochair Dr. Partap Khalsa, program officer of the division of intramural research at NCCAM, noted that the best clinical guidelines currently available for managing chronic low back pain are those developed jointly by the American College of Physicians and the American Pain Society. They advise clinicians to conduct a focused history and physical to help determine etiology, and only perform diagnostic imaging in selected patients with severe or progressive neurologic deficits or in whom serious underlying conditions are suspected based on the history and physical exam (Ann. Intern. Med. 2007;147:478–91).

For the 80%–90% of patients with chronic back pain for whom no specific cause can be found, the guidelines advise that physicians educate patients about appropriate self-care and prescribe acetaminophen or nonsteroidal anti-inflammatory agents as first-line therapy. For patients in whom pain persists, nonpharmacologic approaches such as exercise and spinal manipulation may be tried, along with other “interdisciplinary” approaches such as acupuncture, massage therapy, yoga, cognitive-behavioral therapy, or progressive relaxation therapy.

Disclosures: Dr. Khalsa and Dr. Briggs are government employees with no financial conflicts. Dr. von Korff said he received funding only from the NIH, and Dr. Franklin and Dr. Battié stated that they have no disclosures. Dr. Maixner is a cofounder, officer, and equity shareholder in Algynomics Inc.

ROCKVILLE, MD. — Chronic back pain is an enormously heterogenous and common disorder that might better be examined in observational “Framingham-like studies” than in randomized, controlled clinical trials.

The recommendation was proposed by several presenters at the workshop sponsored by the National Center for Complementary and Alternative Medicine (NCCAM), a division of the National Institutes of Health.

“I think this is the right time to be talking about this problem. The NIH has certainly been urged by our leader, Dr. Francis Collins, to worry about research of relevance to health policy, and I can't think of a single issue that has as much resonance or potential implications for health policy as this one,” NCCAM director Josephine Briggs said.

Dr. Briggs also noted, “This is not my area, but as I've learned more about back pain over the last year, I have been absolutely blown away by the magnitude of this problem and the enormous clinical difficulties in bringing relief to most patients suffering from chronic back pain.… This is a totally pervasive, a huge driver of health costs, and frankly, I think a problem for which we only have a small number of satisfactory clinical solutions, so I think it's incredibly important that we talk about it.”

There was agreement among participants that chronic back pain is not simply a multifaceted biological problem, but also a psychosocial one. And as such, there is little correlation between physical findings on imaging or other studies and the degree to which a patient perceives pain or experiences functional impairment. Participants also generally agreed that current treatments, including opioids and surgical approaches, are ineffective in a large proportion of patients and have been associated with harm as well.

The extensive heterogeneity in causes, presentations, and functional impact of chronic back pain has made it impossible to compare studies on the problem and determine the extent to which results from any given study can be extrapolated to another, speakers agreed.

Indeed, even the most commonly used definition of “chronic”—pain lasting longer than 3 or 6 months—is limiting in that it doesn't account for other parameters such as pain intensity, associated psychological dysfunction, or degree of functional impairment, noted Michael Von Korff, Sc.D., senior investigator at Group Health Research Institute, Seattle.

He described an alternative “prognostic risk score” that would not only classify patients with back pain but would also help to determine their probability of future clinically significant back pain. The score, derived from a study of 1,213 primary care back pain patients, utilizes measurements of degrees of pain intensity, interference with activities, persistence, number of pain sites, and depression to define risk levels corresponding to a 50% and an 80% probability of future clinically significant pain (Pain 2005;117:304–13).

Such an “empirically grounded” approach, he said, could help distinguish patients at low risk who could be managed conservatively from those at greater risk for whom intervention could be initiated early, rather than waiting for the passage of time until they meet the “chronic” criteria. Moreover, “it avoids labeling patients as hopeless, with immutable back pain, when change for the better is always possible and often likely.”

William Maixner, D.D.S., Ph.D., professor and director of the Center for Neurosensory Disorders at the University of North Carolina School of Dentistry, Chapel Hill, said that a study he's heading in patients with temporomandibular joint (TMJ) disorders could also serve as a model for studying chronic back pain.

The 7-year Orofacial Pain: Prospective Evaluation and Risk Assessment (OPPERA), funded by the National Institute of Dental and Craniofacial Research (NIDCR), is the first-ever large, prospective clinical study in the field of chronic pain. Begun in 2005, it enrolled 3,276 initially pain-free adults, and is following them with the aim of identifying underlying pathophysiological, psychological, and genetic risk factors that predict who will go on to develop TMJ disorders.

Michele Crites Battié, Ph.D., of the University of Alberta, Edmonton, called into question whether the outcome measures that have been used so far in back pain studies are actually the most relevant and appropriate for ascertaining clinically meaningful treatment effects. For example, should studies assess mean changes in intervention versus control groups, or measure the difference in percent achieving a clinically meaningful threshold? And beyond that, is the data point being measured one that is meaningful to the patient?

Dr. Gary Franklin, a research professor in environmental and occupational health sciences at the University of Washington, Seattle, said the Food and Drug Administration uses only pain as a primary outcome measure for drug trials, with function and quality of life as secondary outcomes.

Several speakers questioned whether the randomized clinical trial, widely considered the “gold standard” type of study for the efficacy of drugs, is really the best type of trial to examine aspects of such a heterogenous problem as chronic back pain, and whether longitudinal observational “Framingham-like” study might be more appropriate to determine what happens to patients with chronic back pain over time.

In an interview, workshop cochair Dr. Partap Khalsa, program officer of the division of intramural research at NCCAM, noted that the best clinical guidelines currently available for managing chronic low back pain are those developed jointly by the American College of Physicians and the American Pain Society. They advise clinicians to conduct a focused history and physical to help determine etiology, and only perform diagnostic imaging in selected patients with severe or progressive neurologic deficits or in whom serious underlying conditions are suspected based on the history and physical exam (Ann. Intern. Med. 2007;147:478–91).

For the 80%–90% of patients with chronic back pain for whom no specific cause can be found, the guidelines advise that physicians educate patients about appropriate self-care and prescribe acetaminophen or nonsteroidal anti-inflammatory agents as first-line therapy. For patients in whom pain persists, nonpharmacologic approaches such as exercise and spinal manipulation may be tried, along with other “interdisciplinary” approaches such as acupuncture, massage therapy, yoga, cognitive-behavioral therapy, or progressive relaxation therapy.

Disclosures: Dr. Khalsa and Dr. Briggs are government employees with no financial conflicts. Dr. von Korff said he received funding only from the NIH, and Dr. Franklin and Dr. Battié stated that they have no disclosures. Dr. Maixner is a cofounder, officer, and equity shareholder in Algynomics Inc.

ROCKVILLE, MD. — Chronic back pain is an enormously heterogenous and common disorder that might better be examined in observational “Framingham-like studies” than in randomized, controlled clinical trials.

The recommendation was proposed by several presenters at the workshop sponsored by the National Center for Complementary and Alternative Medicine (NCCAM), a division of the National Institutes of Health.

“I think this is the right time to be talking about this problem. The NIH has certainly been urged by our leader, Dr. Francis Collins, to worry about research of relevance to health policy, and I can't think of a single issue that has as much resonance or potential implications for health policy as this one,” NCCAM director Josephine Briggs said.

Dr. Briggs also noted, “This is not my area, but as I've learned more about back pain over the last year, I have been absolutely blown away by the magnitude of this problem and the enormous clinical difficulties in bringing relief to most patients suffering from chronic back pain.… This is a totally pervasive, a huge driver of health costs, and frankly, I think a problem for which we only have a small number of satisfactory clinical solutions, so I think it's incredibly important that we talk about it.”

There was agreement among participants that chronic back pain is not simply a multifaceted biological problem, but also a psychosocial one. And as such, there is little correlation between physical findings on imaging or other studies and the degree to which a patient perceives pain or experiences functional impairment. Participants also generally agreed that current treatments, including opioids and surgical approaches, are ineffective in a large proportion of patients and have been associated with harm as well.

The extensive heterogeneity in causes, presentations, and functional impact of chronic back pain has made it impossible to compare studies on the problem and determine the extent to which results from any given study can be extrapolated to another, speakers agreed.

Indeed, even the most commonly used definition of “chronic”—pain lasting longer than 3 or 6 months—is limiting in that it doesn't account for other parameters such as pain intensity, associated psychological dysfunction, or degree of functional impairment, noted Michael Von Korff, Sc.D., senior investigator at Group Health Research Institute, Seattle.

He described an alternative “prognostic risk score” that would not only classify patients with back pain but would also help to determine their probability of future clinically significant back pain. The score, derived from a study of 1,213 primary care back pain patients, utilizes measurements of degrees of pain intensity, interference with activities, persistence, number of pain sites, and depression to define risk levels corresponding to a 50% and an 80% probability of future clinically significant pain (Pain 2005;117:304–13).

Such an “empirically grounded” approach, he said, could help distinguish patients at low risk who could be managed conservatively from those at greater risk for whom intervention could be initiated early, rather than waiting for the passage of time until they meet the “chronic” criteria. Moreover, “it avoids labeling patients as hopeless, with immutable back pain, when change for the better is always possible and often likely.”

William Maixner, D.D.S., Ph.D., professor and director of the Center for Neurosensory Disorders at the University of North Carolina School of Dentistry, Chapel Hill, said that a study he's heading in patients with temporomandibular joint (TMJ) disorders could also serve as a model for studying chronic back pain.

The 7-year Orofacial Pain: Prospective Evaluation and Risk Assessment (OPPERA), funded by the National Institute of Dental and Craniofacial Research (NIDCR), is the first-ever large, prospective clinical study in the field of chronic pain. Begun in 2005, it enrolled 3,276 initially pain-free adults, and is following them with the aim of identifying underlying pathophysiological, psychological, and genetic risk factors that predict who will go on to develop TMJ disorders.

Michele Crites Battié, Ph.D., of the University of Alberta, Edmonton, called into question whether the outcome measures that have been used so far in back pain studies are actually the most relevant and appropriate for ascertaining clinically meaningful treatment effects. For example, should studies assess mean changes in intervention versus control groups, or measure the difference in percent achieving a clinically meaningful threshold? And beyond that, is the data point being measured one that is meaningful to the patient?

Dr. Gary Franklin, a research professor in environmental and occupational health sciences at the University of Washington, Seattle, said the Food and Drug Administration uses only pain as a primary outcome measure for drug trials, with function and quality of life as secondary outcomes.

Several speakers questioned whether the randomized clinical trial, widely considered the “gold standard” type of study for the efficacy of drugs, is really the best type of trial to examine aspects of such a heterogenous problem as chronic back pain, and whether longitudinal observational “Framingham-like” study might be more appropriate to determine what happens to patients with chronic back pain over time.

In an interview, workshop cochair Dr. Partap Khalsa, program officer of the division of intramural research at NCCAM, noted that the best clinical guidelines currently available for managing chronic low back pain are those developed jointly by the American College of Physicians and the American Pain Society. They advise clinicians to conduct a focused history and physical to help determine etiology, and only perform diagnostic imaging in selected patients with severe or progressive neurologic deficits or in whom serious underlying conditions are suspected based on the history and physical exam (Ann. Intern. Med. 2007;147:478–91).

For the 80%–90% of patients with chronic back pain for whom no specific cause can be found, the guidelines advise that physicians educate patients about appropriate self-care and prescribe acetaminophen or nonsteroidal anti-inflammatory agents as first-line therapy. For patients in whom pain persists, nonpharmacologic approaches such as exercise and spinal manipulation may be tried, along with other “interdisciplinary” approaches such as acupuncture, massage therapy, yoga, cognitive-behavioral therapy, or progressive relaxation therapy.

Disclosures: Dr. Khalsa and Dr. Briggs are government employees with no financial conflicts. Dr. von Korff said he received funding only from the NIH, and Dr. Franklin and Dr. Battié stated that they have no disclosures. Dr. Maixner is a cofounder, officer, and equity shareholder in Algynomics Inc.

A joint consensus statement from the American Diabetes Association and the American Cancer Society released June 16 reviews the current state of science regarding the complex relationship between diabetes and cancer.

Epidemiologic evidence suggests that people with diabetes—type 2 in particular—are at increased risk for cancer. The reasons for this association are poorly understood, but there is evidence to support roles for risk factors that are common to both disorders and medications used to treat diabetes, as well as possible direct causal links.

The American Diabetes Association and the American Cancer Society convened a consensus development conference to examine these associations in December 2009. The writing group independently developed a statement that solely represents the positions of the nine panel members and does not reflect official positions of either sponsoring organization (Diabetes Care 2010;33:1674-85).

The panel, which was chaired by Dr. Edward Giovannucci of the Harvard School of Public Health, Boston, recommended that health care professionals strongly advise patients with diabetes to undergo appropriate cancer screenings as advised for all people in their age and sex categories. Promotion of healthful diets, physical activity, and weight management is encouraged for all patients to reduce risk and improve outcomes of type 2 diabetes and some forms of cancer.

The statement also recommended that cancer risk not be a major factor in choosing between available diabetes therapies for the average patient, but that for selected patients at very high risk for cancer occurrence—or for recurrence of specific cancer types—these issues may require more careful consideration.

The statement was organized around answers to four basic questions:

▸ Is there a meaningful association between diabetes and cancer incidence or prognosis? Cancer and diabetes are diagnosed within the same individual more frequently than would be expected by chance, even after adjustment for age. However, the association appears to be limited to certain types of cancer, while other cancers appear to be less common among people with diabetes. Specifically, type 2 diabetes is associated with an increased risk for cancers of the liver, pancreas, endometrium, colon/rectum, breast, and bladder, but with a reduced risk of prostate cancer. For some other cancer sites there appears to be no association or the evidence is inconclusive.

▸ What factors are common to both cancer and diabetes? The association between diabetes and some cancers may be due in part to shared risk factors between the two diseases, such as aging, obesity, diet, and physical inactivity. Smoking appears to be an independent risk factor for the development of diabetes and diabetes complications, in addition to cancer. Evidence for the role of alcohol is mixed. Even moderate alcohol consumption increases the risk for certain types of cancer and excess alcohol consumption is also a risk factor for diabetes. However, moderate alcohol consumption is linked with a reduced incidence of diabetes.

▸ What are the possible biologic links between diabetes and cancer risk? The document provides detailed summaries of the evidence pertaining to the potential roles of the insulin/insulin-like growth factor receptor axis, hyperglycemia, hyperinsulinemia, and inflammatory cytokines/inflammation.

▸ Do diabetes treatments influence cancer risk or cancer prognosis? The evidence for specific drugs affecting cancer risk is limited, and observed associations may have been confounded by indications for specific drugs, effects on other cancer risk factors such as body weight and hyperinsulinemia, and the complex progressive nature of hyperglycemia and pharmacotherapy in type 2 diabetes.

Although still limited, early evidence suggests that metformin is associated with a lower risk of cancer and that some exogenously administered insulin is associated with an increased cancer risk. Further research is needed to clarify these issues and evaluate if insulin glargine is more strongly associated with cancer risk, compared with other insulins.

The statement also highlights numerous remaining research questions.

The consensus development conference was supported by an unrestricted grant from Amylin Pharmaceuticals Inc., Lilly USA, Merck & Co. Inc., Novo Nordisk A/S, and Sanofi-Aventis. Five of the eight study authors reported financial ties with these and other pharmaceutical companies.

Diabetic patients should undergo cancer screenings as advised for all people in their age and sex categories.

Source DR. GIOVANNUCCI

A joint consensus statement from the American Diabetes Association and the American Cancer Society released June 16 reviews the current state of science regarding the complex relationship between diabetes and cancer.

Epidemiologic evidence suggests that people with diabetes—type 2 in particular—are at increased risk for cancer. The reasons for this association are poorly understood, but there is evidence to support roles for risk factors that are common to both disorders and medications used to treat diabetes, as well as possible direct causal links.

The American Diabetes Association and the American Cancer Society convened a consensus development conference to examine these associations in December 2009. The writing group independently developed a statement that solely represents the positions of the nine panel members and does not reflect official positions of either sponsoring organization (Diabetes Care 2010;33:1674-85).

The panel, which was chaired by Dr. Edward Giovannucci of the Harvard School of Public Health, Boston, recommended that health care professionals strongly advise patients with diabetes to undergo appropriate cancer screenings as advised for all people in their age and sex categories. Promotion of healthful diets, physical activity, and weight management is encouraged for all patients to reduce risk and improve outcomes of type 2 diabetes and some forms of cancer.

The statement also recommended that cancer risk not be a major factor in choosing between available diabetes therapies for the average patient, but that for selected patients at very high risk for cancer occurrence—or for recurrence of specific cancer types—these issues may require more careful consideration.

The statement was organized around answers to four basic questions:

▸ Is there a meaningful association between diabetes and cancer incidence or prognosis? Cancer and diabetes are diagnosed within the same individual more frequently than would be expected by chance, even after adjustment for age. However, the association appears to be limited to certain types of cancer, while other cancers appear to be less common among people with diabetes. Specifically, type 2 diabetes is associated with an increased risk for cancers of the liver, pancreas, endometrium, colon/rectum, breast, and bladder, but with a reduced risk of prostate cancer. For some other cancer sites there appears to be no association or the evidence is inconclusive.

▸ What factors are common to both cancer and diabetes? The association between diabetes and some cancers may be due in part to shared risk factors between the two diseases, such as aging, obesity, diet, and physical inactivity. Smoking appears to be an independent risk factor for the development of diabetes and diabetes complications, in addition to cancer. Evidence for the role of alcohol is mixed. Even moderate alcohol consumption increases the risk for certain types of cancer and excess alcohol consumption is also a risk factor for diabetes. However, moderate alcohol consumption is linked with a reduced incidence of diabetes.

▸ What are the possible biologic links between diabetes and cancer risk? The document provides detailed summaries of the evidence pertaining to the potential roles of the insulin/insulin-like growth factor receptor axis, hyperglycemia, hyperinsulinemia, and inflammatory cytokines/inflammation.

▸ Do diabetes treatments influence cancer risk or cancer prognosis? The evidence for specific drugs affecting cancer risk is limited, and observed associations may have been confounded by indications for specific drugs, effects on other cancer risk factors such as body weight and hyperinsulinemia, and the complex progressive nature of hyperglycemia and pharmacotherapy in type 2 diabetes.

Although still limited, early evidence suggests that metformin is associated with a lower risk of cancer and that some exogenously administered insulin is associated with an increased cancer risk. Further research is needed to clarify these issues and evaluate if insulin glargine is more strongly associated with cancer risk, compared with other insulins.

The statement also highlights numerous remaining research questions.

The consensus development conference was supported by an unrestricted grant from Amylin Pharmaceuticals Inc., Lilly USA, Merck & Co. Inc., Novo Nordisk A/S, and Sanofi-Aventis. Five of the eight study authors reported financial ties with these and other pharmaceutical companies.

Diabetic patients should undergo cancer screenings as advised for all people in their age and sex categories.

Source DR. GIOVANNUCCI

A joint consensus statement from the American Diabetes Association and the American Cancer Society released June 16 reviews the current state of science regarding the complex relationship between diabetes and cancer.

Epidemiologic evidence suggests that people with diabetes—type 2 in particular—are at increased risk for cancer. The reasons for this association are poorly understood, but there is evidence to support roles for risk factors that are common to both disorders and medications used to treat diabetes, as well as possible direct causal links.

The American Diabetes Association and the American Cancer Society convened a consensus development conference to examine these associations in December 2009. The writing group independently developed a statement that solely represents the positions of the nine panel members and does not reflect official positions of either sponsoring organization (Diabetes Care 2010;33:1674-85).

The panel, which was chaired by Dr. Edward Giovannucci of the Harvard School of Public Health, Boston, recommended that health care professionals strongly advise patients with diabetes to undergo appropriate cancer screenings as advised for all people in their age and sex categories. Promotion of healthful diets, physical activity, and weight management is encouraged for all patients to reduce risk and improve outcomes of type 2 diabetes and some forms of cancer.

The statement also recommended that cancer risk not be a major factor in choosing between available diabetes therapies for the average patient, but that for selected patients at very high risk for cancer occurrence—or for recurrence of specific cancer types—these issues may require more careful consideration.

The statement was organized around answers to four basic questions:

▸ Is there a meaningful association between diabetes and cancer incidence or prognosis? Cancer and diabetes are diagnosed within the same individual more frequently than would be expected by chance, even after adjustment for age. However, the association appears to be limited to certain types of cancer, while other cancers appear to be less common among people with diabetes. Specifically, type 2 diabetes is associated with an increased risk for cancers of the liver, pancreas, endometrium, colon/rectum, breast, and bladder, but with a reduced risk of prostate cancer. For some other cancer sites there appears to be no association or the evidence is inconclusive.

▸ What factors are common to both cancer and diabetes? The association between diabetes and some cancers may be due in part to shared risk factors between the two diseases, such as aging, obesity, diet, and physical inactivity. Smoking appears to be an independent risk factor for the development of diabetes and diabetes complications, in addition to cancer. Evidence for the role of alcohol is mixed. Even moderate alcohol consumption increases the risk for certain types of cancer and excess alcohol consumption is also a risk factor for diabetes. However, moderate alcohol consumption is linked with a reduced incidence of diabetes.

▸ What are the possible biologic links between diabetes and cancer risk? The document provides detailed summaries of the evidence pertaining to the potential roles of the insulin/insulin-like growth factor receptor axis, hyperglycemia, hyperinsulinemia, and inflammatory cytokines/inflammation.

▸ Do diabetes treatments influence cancer risk or cancer prognosis? The evidence for specific drugs affecting cancer risk is limited, and observed associations may have been confounded by indications for specific drugs, effects on other cancer risk factors such as body weight and hyperinsulinemia, and the complex progressive nature of hyperglycemia and pharmacotherapy in type 2 diabetes.

Although still limited, early evidence suggests that metformin is associated with a lower risk of cancer and that some exogenously administered insulin is associated with an increased cancer risk. Further research is needed to clarify these issues and evaluate if insulin glargine is more strongly associated with cancer risk, compared with other insulins.

The statement also highlights numerous remaining research questions.

The consensus development conference was supported by an unrestricted grant from Amylin Pharmaceuticals Inc., Lilly USA, Merck & Co. Inc., Novo Nordisk A/S, and Sanofi-Aventis. Five of the eight study authors reported financial ties with these and other pharmaceutical companies.

Diabetic patients should undergo cancer screenings as advised for all people in their age and sex categories.

Source DR. GIOVANNUCCI

ORLANDO — A community-based lifestyle intervention program significantly reduced body weight and waist circumference and lowered fasting blood glucose levels at 1 year compared with usual care in a study of 301 adults with prediabetes.

Results of the Healthy Living Partnerships to Prevent Diabetes (HELP PD) study were presented by Dr. David C. Goff, chair of the department of epidemiology and prevention at Wake Forest University. The intervention was modeled after the landmark Diabetes Prevention Program (DPP) study, in which individuals at high risk for type 2 diabetes who received individual lifestyle counseling had a 58% reduction in the development of diabetes over a 3-year period (N. Engl. J. Med. 2002;346:393-403). Both studies were funded by the National Institute of Diabetes, Digestive and Kidney Diseases.

“In the 7 years since publication of the DPP, there has been great interest in developing and testing ways to translate those behavioral weight loss approaches to community settings in ways that can reach the large population of people with prediabetes,” Dr. Goff said during a press briefing held at the American Diabetes Association meeting.

In HELP PD, the DPP intervention was modified to a group-based counseling session with about 10-14 people per group. In another difference, specially trained lay community health workers who had brought their diabetes under control delivered the intervention, which included encouragement to change eating behaviors and to exercise for up to 180 minutes per week, with an emphasis on walking.

In the intervention group, sessions were held weekly for the first 6 months and monthly for the next 18 months. The usual-care group received two individual sessions with a registered dietician during the first 3 months of the study and a monthly newsletter throughout the 2 years. Telephone calls were also included.

The subject population was about 40% male, about 75% white, and slightly less than a 25% African-American. They had a mean age of 58 years, a mean body weight of 94 kg, the mean BMI was 33 kg/m

Subjects in the intervention group lost an average of 7 kg in the first intervention year, compared with a loss of 1.5 kg in the usual care group. Waist circumference was reduced by 5.9 cm in the intervention group, compared with less than 1 cm with usual care.

The primary end point, fasting glucose, dropped by 4.2 mg/dL in the first year, compared with 0.3-mg/dL in the usual-care group. All of these comparisons are highly statistically significant. Fasting insulin levels also declined, Dr. Goff said.

Neither overall nor serious adverse events differed between the two groups. Although the sample size wasn't large enough to assess the development of diabetes with statistical significance, there have been fewer cases among the intervention group participants, consistent with the 4-mg/dL reduction in fasting glucose. Monitoring for diabetes will be continued into a second year along with the other parameters, he said.

There are currently approximately 3,000 diabetes education programs around the country that are recognized by the ADA.

Dr. Goff stated that he has received funding for diabetes-related research from Merck and has served on a safety monitoring board for Takeda.

ORLANDO — A community-based lifestyle intervention program significantly reduced body weight and waist circumference and lowered fasting blood glucose levels at 1 year compared with usual care in a study of 301 adults with prediabetes.

Results of the Healthy Living Partnerships to Prevent Diabetes (HELP PD) study were presented by Dr. David C. Goff, chair of the department of epidemiology and prevention at Wake Forest University. The intervention was modeled after the landmark Diabetes Prevention Program (DPP) study, in which individuals at high risk for type 2 diabetes who received individual lifestyle counseling had a 58% reduction in the development of diabetes over a 3-year period (N. Engl. J. Med. 2002;346:393-403). Both studies were funded by the National Institute of Diabetes, Digestive and Kidney Diseases.

“In the 7 years since publication of the DPP, there has been great interest in developing and testing ways to translate those behavioral weight loss approaches to community settings in ways that can reach the large population of people with prediabetes,” Dr. Goff said during a press briefing held at the American Diabetes Association meeting.

In HELP PD, the DPP intervention was modified to a group-based counseling session with about 10-14 people per group. In another difference, specially trained lay community health workers who had brought their diabetes under control delivered the intervention, which included encouragement to change eating behaviors and to exercise for up to 180 minutes per week, with an emphasis on walking.

In the intervention group, sessions were held weekly for the first 6 months and monthly for the next 18 months. The usual-care group received two individual sessions with a registered dietician during the first 3 months of the study and a monthly newsletter throughout the 2 years. Telephone calls were also included.

The subject population was about 40% male, about 75% white, and slightly less than a 25% African-American. They had a mean age of 58 years, a mean body weight of 94 kg, the mean BMI was 33 kg/m

Subjects in the intervention group lost an average of 7 kg in the first intervention year, compared with a loss of 1.5 kg in the usual care group. Waist circumference was reduced by 5.9 cm in the intervention group, compared with less than 1 cm with usual care.

The primary end point, fasting glucose, dropped by 4.2 mg/dL in the first year, compared with 0.3-mg/dL in the usual-care group. All of these comparisons are highly statistically significant. Fasting insulin levels also declined, Dr. Goff said.

Neither overall nor serious adverse events differed between the two groups. Although the sample size wasn't large enough to assess the development of diabetes with statistical significance, there have been fewer cases among the intervention group participants, consistent with the 4-mg/dL reduction in fasting glucose. Monitoring for diabetes will be continued into a second year along with the other parameters, he said.

There are currently approximately 3,000 diabetes education programs around the country that are recognized by the ADA.

Dr. Goff stated that he has received funding for diabetes-related research from Merck and has served on a safety monitoring board for Takeda.

ORLANDO — A community-based lifestyle intervention program significantly reduced body weight and waist circumference and lowered fasting blood glucose levels at 1 year compared with usual care in a study of 301 adults with prediabetes.

Results of the Healthy Living Partnerships to Prevent Diabetes (HELP PD) study were presented by Dr. David C. Goff, chair of the department of epidemiology and prevention at Wake Forest University. The intervention was modeled after the landmark Diabetes Prevention Program (DPP) study, in which individuals at high risk for type 2 diabetes who received individual lifestyle counseling had a 58% reduction in the development of diabetes over a 3-year period (N. Engl. J. Med. 2002;346:393-403). Both studies were funded by the National Institute of Diabetes, Digestive and Kidney Diseases.

“In the 7 years since publication of the DPP, there has been great interest in developing and testing ways to translate those behavioral weight loss approaches to community settings in ways that can reach the large population of people with prediabetes,” Dr. Goff said during a press briefing held at the American Diabetes Association meeting.

In HELP PD, the DPP intervention was modified to a group-based counseling session with about 10-14 people per group. In another difference, specially trained lay community health workers who had brought their diabetes under control delivered the intervention, which included encouragement to change eating behaviors and to exercise for up to 180 minutes per week, with an emphasis on walking.

In the intervention group, sessions were held weekly for the first 6 months and monthly for the next 18 months. The usual-care group received two individual sessions with a registered dietician during the first 3 months of the study and a monthly newsletter throughout the 2 years. Telephone calls were also included.

The subject population was about 40% male, about 75% white, and slightly less than a 25% African-American. They had a mean age of 58 years, a mean body weight of 94 kg, the mean BMI was 33 kg/m

Subjects in the intervention group lost an average of 7 kg in the first intervention year, compared with a loss of 1.5 kg in the usual care group. Waist circumference was reduced by 5.9 cm in the intervention group, compared with less than 1 cm with usual care.

The primary end point, fasting glucose, dropped by 4.2 mg/dL in the first year, compared with 0.3-mg/dL in the usual-care group. All of these comparisons are highly statistically significant. Fasting insulin levels also declined, Dr. Goff said.

Neither overall nor serious adverse events differed between the two groups. Although the sample size wasn't large enough to assess the development of diabetes with statistical significance, there have been fewer cases among the intervention group participants, consistent with the 4-mg/dL reduction in fasting glucose. Monitoring for diabetes will be continued into a second year along with the other parameters, he said.

There are currently approximately 3,000 diabetes education programs around the country that are recognized by the ADA.

Dr. Goff stated that he has received funding for diabetes-related research from Merck and has served on a safety monitoring board for Takeda.

ORLANDO — Intensive glycemic control did not reduce the risk for developing advanced measures of microvascular outcomes, although it did delay the onset of albuminuria and some measures of eye complications and neuropathy among patients with longstanding type 2 diabetes at high cardiovascular risk.

The mixed results, from a subanalysis of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, suggest that the microvascular benefits of intensive therapy should be weighed against the increase in total disease-related mortality, increased weight gain, and high risk for severe hypoglycemia that emerged with the main findings of the trial 2 years ago, said Dr. Faramarz Ismail-Beigi said of Case Western Reserve University, Cleveland. The findings were released simultaneously online in the Lancet (doi:10.1016/S0140-6736(10)60576-4).

The ACCORD trial randomized 10,251 adults with type 2 diabetes to either intensive glycemic control with a target hemoglobin A_1c of less than 6.0%, or standard therapy aiming for HbA_1c values of 7.0%-7.9%. The intensive arm was stopped early in February 2008—after a median follow-up of 3.7 years—because of a 22% higher all-cause mortality in the intensive group. They were then transitioned to standard therapy for the rest of the trial, which also included blood pressure and lipid control arms (N. Engl. J. Med. 2008;358:2545-59).

At the time of that transition and at study end, the two groups did not differ in the prespecified primary composite outcome of advanced nephropathy and diabetic eye complications (development of renal failure or retinal photocoagulation or vitrectomy to treat retinopathy), nor in a second composite end point that added a peripheral neuropathy outcome (score of greater than 2.0 on the Michigan neuropathy screening instrument or the first composite outcome). At the end of the study, 10.9% of the intensive group and 11.5% of the standard treatment group met the first composite end point, and 38.2% and 40.0%, respectively, met the second.

However, microvascular renal outcomes based on urinary measures were significantly reduced in the intensive glycemic therapy group. Intensive glycemia therapy led to a 21% reduction in the development of microalbuminuria at the time of transition. This effect was attenuated to 15% at study end, but remained statistically significant, Dr. Ismail-Beigi reported.

For diabetes-related eye events, three-line worsening of visual acuity was more common in the standard group than in the intensive group at both transition and study end (20.7% vs. 19.1%). Peripheral neuropathy (MNSI greater than 2.0) was less common in the intensive group than in the standard group at study end (55.6% vs. 58.6%).

The ACCORD trial was funded by the National Heart, Lung, and Blood Institute, with contributions of medications, equipment, or supplies from several manufacturers.

Several coauthors declared financial relationships with many manufacturers of diabetes-related products.

Weigh the risks vs. benefits of intense therapy, said Dr. Faramarz Ismail-Beigi (right).

Source Miriam E. Tucker/Elsevier Global Medical News

ORLANDO — Intensive glycemic control did not reduce the risk for developing advanced measures of microvascular outcomes, although it did delay the onset of albuminuria and some measures of eye complications and neuropathy among patients with longstanding type 2 diabetes at high cardiovascular risk.

The mixed results, from a subanalysis of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, suggest that the microvascular benefits of intensive therapy should be weighed against the increase in total disease-related mortality, increased weight gain, and high risk for severe hypoglycemia that emerged with the main findings of the trial 2 years ago, said Dr. Faramarz Ismail-Beigi said of Case Western Reserve University, Cleveland. The findings were released simultaneously online in the Lancet (doi:10.1016/S0140-6736(10)60576-4).

The ACCORD trial randomized 10,251 adults with type 2 diabetes to either intensive glycemic control with a target hemoglobin A_1c of less than 6.0%, or standard therapy aiming for HbA_1c values of 7.0%-7.9%. The intensive arm was stopped early in February 2008—after a median follow-up of 3.7 years—because of a 22% higher all-cause mortality in the intensive group. They were then transitioned to standard therapy for the rest of the trial, which also included blood pressure and lipid control arms (N. Engl. J. Med. 2008;358:2545-59).

At the time of that transition and at study end, the two groups did not differ in the prespecified primary composite outcome of advanced nephropathy and diabetic eye complications (development of renal failure or retinal photocoagulation or vitrectomy to treat retinopathy), nor in a second composite end point that added a peripheral neuropathy outcome (score of greater than 2.0 on the Michigan neuropathy screening instrument or the first composite outcome). At the end of the study, 10.9% of the intensive group and 11.5% of the standard treatment group met the first composite end point, and 38.2% and 40.0%, respectively, met the second.

However, microvascular renal outcomes based on urinary measures were significantly reduced in the intensive glycemic therapy group. Intensive glycemia therapy led to a 21% reduction in the development of microalbuminuria at the time of transition. This effect was attenuated to 15% at study end, but remained statistically significant, Dr. Ismail-Beigi reported.

For diabetes-related eye events, three-line worsening of visual acuity was more common in the standard group than in the intensive group at both transition and study end (20.7% vs. 19.1%). Peripheral neuropathy (MNSI greater than 2.0) was less common in the intensive group than in the standard group at study end (55.6% vs. 58.6%).

The ACCORD trial was funded by the National Heart, Lung, and Blood Institute, with contributions of medications, equipment, or supplies from several manufacturers.

Several coauthors declared financial relationships with many manufacturers of diabetes-related products.

Weigh the risks vs. benefits of intense therapy, said Dr. Faramarz Ismail-Beigi (right).

Source Miriam E. Tucker/Elsevier Global Medical News

ORLANDO — Intensive glycemic control did not reduce the risk for developing advanced measures of microvascular outcomes, although it did delay the onset of albuminuria and some measures of eye complications and neuropathy among patients with longstanding type 2 diabetes at high cardiovascular risk.

The mixed results, from a subanalysis of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, suggest that the microvascular benefits of intensive therapy should be weighed against the increase in total disease-related mortality, increased weight gain, and high risk for severe hypoglycemia that emerged with the main findings of the trial 2 years ago, said Dr. Faramarz Ismail-Beigi said of Case Western Reserve University, Cleveland. The findings were released simultaneously online in the Lancet (doi:10.1016/S0140-6736(10)60576-4).

The ACCORD trial randomized 10,251 adults with type 2 diabetes to either intensive glycemic control with a target hemoglobin A_1c of less than 6.0%, or standard therapy aiming for HbA_1c values of 7.0%-7.9%. The intensive arm was stopped early in February 2008—after a median follow-up of 3.7 years—because of a 22% higher all-cause mortality in the intensive group. They were then transitioned to standard therapy for the rest of the trial, which also included blood pressure and lipid control arms (N. Engl. J. Med. 2008;358:2545-59).

At the time of that transition and at study end, the two groups did not differ in the prespecified primary composite outcome of advanced nephropathy and diabetic eye complications (development of renal failure or retinal photocoagulation or vitrectomy to treat retinopathy), nor in a second composite end point that added a peripheral neuropathy outcome (score of greater than 2.0 on the Michigan neuropathy screening instrument or the first composite outcome). At the end of the study, 10.9% of the intensive group and 11.5% of the standard treatment group met the first composite end point, and 38.2% and 40.0%, respectively, met the second.

However, microvascular renal outcomes based on urinary measures were significantly reduced in the intensive glycemic therapy group. Intensive glycemia therapy led to a 21% reduction in the development of microalbuminuria at the time of transition. This effect was attenuated to 15% at study end, but remained statistically significant, Dr. Ismail-Beigi reported.

For diabetes-related eye events, three-line worsening of visual acuity was more common in the standard group than in the intensive group at both transition and study end (20.7% vs. 19.1%). Peripheral neuropathy (MNSI greater than 2.0) was less common in the intensive group than in the standard group at study end (55.6% vs. 58.6%).

The ACCORD trial was funded by the National Heart, Lung, and Blood Institute, with contributions of medications, equipment, or supplies from several manufacturers.

Several coauthors declared financial relationships with many manufacturers of diabetes-related products.

Weigh the risks vs. benefits of intense therapy, said Dr. Faramarz Ismail-Beigi (right).

Source Miriam E. Tucker/Elsevier Global Medical News

Major Finding: Length of stay averaged 5.0 days with endocrine intervention vs. 5.8 days without, while costs per stay dropped from $9,301 to $8,009.

Data Source: Observational study of 1-year time periods with and without endocrine intervention for hospitalized surgical patients at an urban tertiary care hospital.

Disclosures: Dr. Chernoff stated that he had no disclosures.

BOSTON — Endocrine intervention resulted in a cost savings of more than $1 million among 820 hospitalized surgical patients with diabetes at an urban tertiary care hospital in Philadelphia.

Proactive consultation by an endocrinologist and a diabetes nurse-educator for surgical patients found to have abnormal glucose levels also reduced the average length of stay by nearly a day. “The bottom line is that endocrine intervention in surgical patients does pay, in terms of both cost savings to the hospital and quality of care for the patient,” Dr. Arthur Chernoff said at the meeting.

Adult patient data for admissions during July 2008–June 2009 (FY09) were compared with those of historical controls during July 2007–June 2008 (FY08). During the FY09 study period, endocrine intervention was triggered by a lab report of a blood glucose level above 199 mg/dL or below 50 mg/dL. Blood glucose management was individualized by the endocrinologist with the help of diabetes educators.

During the control period, the diabetic patients received care based on previously deployed protocols for the management of hyperglycemia in the ICU, hypoglycemia in all units, and insulin order sets.

In contrast to the control period, when an endocrinologist was typically called in only when there was a problem, “the key element of the intervention was to be proactive rather than reactive in the care of the diabetic patient,” said Dr. Chernoff, chair of the division of endocrinology and medical director of the Gutman Diabetes Institute at Albert Einstein Medical Center, Philadelphia.

There were 820 patients with and 2,534 without diabetes in the FY09 period and 681 with and 2,516 without diabetes in FY08. The diabetes patients were older than those without (59 vs. 49 years in FY09 and 61 vs. 50 years in FY08), but race and sex did not differ between the two groups, Dr. Chernoff reported in a poster.

Among the diabetic patients, length of stay was significantly lower during FY09, an average 5 days vs. 5.8 days in FY08. Time in the ICU also dropped, from 0.90 to 0.69 days. Among patients without diabetes, total length of stay did not differ significantly during the two time periods (4.1 in FY09 vs. 4.4 days in FY08), nor did time in the ICU (0.88 in FY09 vs. 0.87 in FY08).

Total expense for the hospital stay averaged $8,009 in FY09, a significant decrease from the average $9,301 in FY08. In contrast, hospital stay expense among those without diabetes improved only slightly, $7,440 in FY09 vs. $7,548 in FY08. Among all the hospitalized surgical patients, the total savings between the two time periods was 1,342 days and $1.15 million, of which half the days (656) and 92% of the cost ($1.06 million) were due to the improvements among those with diabetes, Dr. Chernoff noted.

Savings in length of stay and expense in the diabetic group were not due to a shifting of costs to other facilities or to increased mortality. The proportion discharged home from the hospital rose slightly, from 78% in FY08 to 79% in FY09, while deaths dropped from 1.8% to 1.6%.

In an interview, Dr. Chernoff said that the proactive nature of the intervention is the key to its success. “The idea is not waiting for trouble, but to be ahead of trouble and prevent all the rookie mistakes of those not familiar with diabetes. Some mistakes that we see over and over again can be avoided.”

“The key element of the intervention was to be proactive rather than reactive,” Dr. Arthur Chernoff said.

Source Miriam E. Tucker/Elsevier Global Medical News

Major Finding: Length of stay averaged 5.0 days with endocrine intervention vs. 5.8 days without, while costs per stay dropped from $9,301 to $8,009.

Data Source: Observational study of 1-year time periods with and without endocrine intervention for hospitalized surgical patients at an urban tertiary care hospital.

Disclosures: Dr. Chernoff stated that he had no disclosures.

BOSTON — Endocrine intervention resulted in a cost savings of more than $1 million among 820 hospitalized surgical patients with diabetes at an urban tertiary care hospital in Philadelphia.

Proactive consultation by an endocrinologist and a diabetes nurse-educator for surgical patients found to have abnormal glucose levels also reduced the average length of stay by nearly a day. “The bottom line is that endocrine intervention in surgical patients does pay, in terms of both cost savings to the hospital and quality of care for the patient,” Dr. Arthur Chernoff said at the meeting.

Adult patient data for admissions during July 2008–June 2009 (FY09) were compared with those of historical controls during July 2007–June 2008 (FY08). During the FY09 study period, endocrine intervention was triggered by a lab report of a blood glucose level above 199 mg/dL or below 50 mg/dL. Blood glucose management was individualized by the endocrinologist with the help of diabetes educators.

During the control period, the diabetic patients received care based on previously deployed protocols for the management of hyperglycemia in the ICU, hypoglycemia in all units, and insulin order sets.

In contrast to the control period, when an endocrinologist was typically called in only when there was a problem, “the key element of the intervention was to be proactive rather than reactive in the care of the diabetic patient,” said Dr. Chernoff, chair of the division of endocrinology and medical director of the Gutman Diabetes Institute at Albert Einstein Medical Center, Philadelphia.

There were 820 patients with and 2,534 without diabetes in the FY09 period and 681 with and 2,516 without diabetes in FY08. The diabetes patients were older than those without (59 vs. 49 years in FY09 and 61 vs. 50 years in FY08), but race and sex did not differ between the two groups, Dr. Chernoff reported in a poster.

Among the diabetic patients, length of stay was significantly lower during FY09, an average 5 days vs. 5.8 days in FY08. Time in the ICU also dropped, from 0.90 to 0.69 days. Among patients without diabetes, total length of stay did not differ significantly during the two time periods (4.1 in FY09 vs. 4.4 days in FY08), nor did time in the ICU (0.88 in FY09 vs. 0.87 in FY08).

Total expense for the hospital stay averaged $8,009 in FY09, a significant decrease from the average $9,301 in FY08. In contrast, hospital stay expense among those without diabetes improved only slightly, $7,440 in FY09 vs. $7,548 in FY08. Among all the hospitalized surgical patients, the total savings between the two time periods was 1,342 days and $1.15 million, of which half the days (656) and 92% of the cost ($1.06 million) were due to the improvements among those with diabetes, Dr. Chernoff noted.

Savings in length of stay and expense in the diabetic group were not due to a shifting of costs to other facilities or to increased mortality. The proportion discharged home from the hospital rose slightly, from 78% in FY08 to 79% in FY09, while deaths dropped from 1.8% to 1.6%.

In an interview, Dr. Chernoff said that the proactive nature of the intervention is the key to its success. “The idea is not waiting for trouble, but to be ahead of trouble and prevent all the rookie mistakes of those not familiar with diabetes. Some mistakes that we see over and over again can be avoided.”

“The key element of the intervention was to be proactive rather than reactive,” Dr. Arthur Chernoff said.

Source Miriam E. Tucker/Elsevier Global Medical News

Major Finding: Length of stay averaged 5.0 days with endocrine intervention vs. 5.8 days without, while costs per stay dropped from $9,301 to $8,009.

Data Source: Observational study of 1-year time periods with and without endocrine intervention for hospitalized surgical patients at an urban tertiary care hospital.

Disclosures: Dr. Chernoff stated that he had no disclosures.

BOSTON — Endocrine intervention resulted in a cost savings of more than $1 million among 820 hospitalized surgical patients with diabetes at an urban tertiary care hospital in Philadelphia.

Proactive consultation by an endocrinologist and a diabetes nurse-educator for surgical patients found to have abnormal glucose levels also reduced the average length of stay by nearly a day. “The bottom line is that endocrine intervention in surgical patients does pay, in terms of both cost savings to the hospital and quality of care for the patient,” Dr. Arthur Chernoff said at the meeting.

Adult patient data for admissions during July 2008–June 2009 (FY09) were compared with those of historical controls during July 2007–June 2008 (FY08). During the FY09 study period, endocrine intervention was triggered by a lab report of a blood glucose level above 199 mg/dL or below 50 mg/dL. Blood glucose management was individualized by the endocrinologist with the help of diabetes educators.

During the control period, the diabetic patients received care based on previously deployed protocols for the management of hyperglycemia in the ICU, hypoglycemia in all units, and insulin order sets.

In contrast to the control period, when an endocrinologist was typically called in only when there was a problem, “the key element of the intervention was to be proactive rather than reactive in the care of the diabetic patient,” said Dr. Chernoff, chair of the division of endocrinology and medical director of the Gutman Diabetes Institute at Albert Einstein Medical Center, Philadelphia.

There were 820 patients with and 2,534 without diabetes in the FY09 period and 681 with and 2,516 without diabetes in FY08. The diabetes patients were older than those without (59 vs. 49 years in FY09 and 61 vs. 50 years in FY08), but race and sex did not differ between the two groups, Dr. Chernoff reported in a poster.

Among the diabetic patients, length of stay was significantly lower during FY09, an average 5 days vs. 5.8 days in FY08. Time in the ICU also dropped, from 0.90 to 0.69 days. Among patients without diabetes, total length of stay did not differ significantly during the two time periods (4.1 in FY09 vs. 4.4 days in FY08), nor did time in the ICU (0.88 in FY09 vs. 0.87 in FY08).

Total expense for the hospital stay averaged $8,009 in FY09, a significant decrease from the average $9,301 in FY08. In contrast, hospital stay expense among those without diabetes improved only slightly, $7,440 in FY09 vs. $7,548 in FY08. Among all the hospitalized surgical patients, the total savings between the two time periods was 1,342 days and $1.15 million, of which half the days (656) and 92% of the cost ($1.06 million) were due to the improvements among those with diabetes, Dr. Chernoff noted.

Savings in length of stay and expense in the diabetic group were not due to a shifting of costs to other facilities or to increased mortality. The proportion discharged home from the hospital rose slightly, from 78% in FY08 to 79% in FY09, while deaths dropped from 1.8% to 1.6%.

In an interview, Dr. Chernoff said that the proactive nature of the intervention is the key to its success. “The idea is not waiting for trouble, but to be ahead of trouble and prevent all the rookie mistakes of those not familiar with diabetes. Some mistakes that we see over and over again can be avoided.”

“The key element of the intervention was to be proactive rather than reactive,” Dr. Arthur Chernoff said.

Source Miriam E. Tucker/Elsevier Global Medical News

BOSTON — Statin therapy was associated with a significantly reduced risk for Candida colonization or infection in patients with type 2 diabetes who were undergoing gastrointestinal tract surgery.

Of the total 1,019 patients who underwent the surgery between January 1, 2001 and May 1, 2008, 48% (493) received statin therapy and 52% (526) did not. Those with statin exposure were older (67.8 vs. 64.9 years, respectively), and had a higher modified Charleson comorbidity index, Dr. Ilias Spanakis said.

A total of 139 patients developed Candida colonization or infection. After adjustment for major confounders, statin use was associated with a statistically significant 40% reduction in the development of Candida colonization or infection (odds ratio, 0.60).

Statins were associated with reduced risk of Candida colonization or infection regardless of Charleson score, although there was a greater apparent benefit of statins in those with scores of 2 or higher, indicating more comorbidity. In that group, there was a 53% reduction in Candida colonization with statins, said Dr. Spanakis of Massachusetts General Hospital, Boston.

Dr. Spanakis said he had no financial disclosures. His coauthor, Dr. Eleftherios Mylonakis, has received research support from Astellas Pharma US Inc., and was a member of the speakers bureau for Pfizer Inc.

BOSTON — Statin therapy was associated with a significantly reduced risk for Candida colonization or infection in patients with type 2 diabetes who were undergoing gastrointestinal tract surgery.

Of the total 1,019 patients who underwent the surgery between January 1, 2001 and May 1, 2008, 48% (493) received statin therapy and 52% (526) did not. Those with statin exposure were older (67.8 vs. 64.9 years, respectively), and had a higher modified Charleson comorbidity index, Dr. Ilias Spanakis said.

A total of 139 patients developed Candida colonization or infection. After adjustment for major confounders, statin use was associated with a statistically significant 40% reduction in the development of Candida colonization or infection (odds ratio, 0.60).

Statins were associated with reduced risk of Candida colonization or infection regardless of Charleson score, although there was a greater apparent benefit of statins in those with scores of 2 or higher, indicating more comorbidity. In that group, there was a 53% reduction in Candida colonization with statins, said Dr. Spanakis of Massachusetts General Hospital, Boston.

Dr. Spanakis said he had no financial disclosures. His coauthor, Dr. Eleftherios Mylonakis, has received research support from Astellas Pharma US Inc., and was a member of the speakers bureau for Pfizer Inc.

BOSTON — Statin therapy was associated with a significantly reduced risk for Candida colonization or infection in patients with type 2 diabetes who were undergoing gastrointestinal tract surgery.

Of the total 1,019 patients who underwent the surgery between January 1, 2001 and May 1, 2008, 48% (493) received statin therapy and 52% (526) did not. Those with statin exposure were older (67.8 vs. 64.9 years, respectively), and had a higher modified Charleson comorbidity index, Dr. Ilias Spanakis said.

A total of 139 patients developed Candida colonization or infection. After adjustment for major confounders, statin use was associated with a statistically significant 40% reduction in the development of Candida colonization or infection (odds ratio, 0.60).

Statins were associated with reduced risk of Candida colonization or infection regardless of Charleson score, although there was a greater apparent benefit of statins in those with scores of 2 or higher, indicating more comorbidity. In that group, there was a 53% reduction in Candida colonization with statins, said Dr. Spanakis of Massachusetts General Hospital, Boston.

Dr. Spanakis said he had no financial disclosures. His coauthor, Dr. Eleftherios Mylonakis, has received research support from Astellas Pharma US Inc., and was a member of the speakers bureau for Pfizer Inc.

Major Finding: Nonalcoholic fatty liver disease in obese children, adolescents, and young adults was twice as high among males as females, with 27% vs. 13% having ALT levels above 40 IU/L. The NAFLD prevalence increased with age in males but decreased with age in females.

Data Source: A prospective, cross-sectional study of 156 obese youth aged 5-20 years.

Disclosures: Dr. Gupta stated that he had no conflicts of interest.

BOSTON — Nonalcoholic fatty liver disease was found in nearly 1 in 5 of 156 obese children and young adults aged 5-20 years in a cross-sectional analysis.

In the study—the first to assess the prevalence of nonalcoholic fatty liver disease (NAFLD) in obese children by sex and age—more than half of the males aged 16-20 years had NAFLD. “Obesity in children is not a cosmetic disease. There are real complications,” Dr. Rishi Gupta reported at the meeting.

The findings suggest that liver function testing should be considered in obese children with dyslipidemia and/or insulin resistance, said Dr. Gupta, a pediatric endocrinology fellow at the State University of New York Downstate Medical Center, Brooklyn.

The multiethnic group of 86 females and 70 males all had body mass indexes (BMIs) greater than the 95th percentile, but did not have diabetes, abnormal thyroid function, or liver disease due to hepatitis or Wilson's disease. A total of 30 (19%) had levels of alanine aminotransferase (ALT) greater than 40 IU/L, generally considered the cutoff to indicate NAFLD. More recently, cutoffs of greater than 30 IU/L for males and 19 IU/L for females are now being used in Europe and in some U.S. labs.

The subjects with elevated ALT did not differ from those with ALT levels at or below 40 IU/L in age (average, 12 years) or BMI (34 kg/m

The prevalence of NAFLD was twice as high in the males as the females, with 27% vs. 13% having ALT levels above 40 IU/L. Males with NAFLD had significantly higher triglycerides than did females with NAFLD (231 vs. 193 mg/dL), and also had lower HDL cholesterol (34 vs. 35 mg/dL). Males and females with NAFLD did not differ significantly with respect to age, BMI, or HOMA-IR.

The prevalence of NAFLD rose with age, from 14.5% for 5- to 10-year-olds to 18% for 11- to 15-year-olds, to 31% for 16- to 20-year-olds. However, when broken down by sex, the prevalence of NAFLD actually dropped with age in the females, from 15.1% in the youngest group to 14.7% in the 11- to 15-year group to 7.1% in the older teens/young adults. In contrast, among males the NAFLD, prevalence rose with age from 13.6% to 24.2% to 53%.

Over half of obese males aged 16-20 years had NAFLD, said Dr. Rishi Gupta.

Source ©Jean Whiteside Photography

My Take

Labs Incorrectly ID ALT Thresholds

The findings by Dr. Gupta and associates are consistent with the existing literature and society guidelines created because of the high rates of NAFLD in overweight and obese children.

The Study of Child and Adolescent Liver Epidemiology was a large autopsy series in a community-wide setting. Based upon liver histology, this study estimated the prevalence of NAFLD at 9.6% in children aged 2-19 years. Moreover, it was demonstrated that fatty liver prevalence increases with age, is higher in boys than girls, and is high in Hispanics and low in African Americans (Pediatrics 2006;118;1388-93).

Three years ago, an expert committee assembled by the Centers for Disease Control and Prevention, the American Medical Association, and 15 health organizations released recommendations on the Assessment, Prevention, and Treatment of Child and Adolescent Overweight and Obesity. Within those guidelines are recommendations that children aged 10 years and older should receive biannual screening for NAFLD if they have a BMI at the 95th percentile or greater (obese) or a BMI between the 85th and 94th percentiles (overweight) and other risk factors. Furthermore, the committee recommended that an ALT or aspartate transaminase (AST) result twice that of normal levels should prompt a consultation with a pediatric hepatologist (Pediatrics 2007;120:S164-92).

Two years ago, the Lawson Wilkins Pediatric Endocrine Society and the Endocrinology Society published guidelines suggesting that obese children, regardless of age, be screened for NAFLD (J. Clin. Endocrinol. Metab. 2008;93:4576-99).

Last month, a new publication from our group showed that ALT is incorrectly interpreted in many children's hospitals throughout the United States. Imagine that a primary care physician keeps up with the latest guidelines and correctly screens a child for liver disease but never knows that the child has liver disease because the electronic medical system does not flag the results with an “H,” because the laboratory is using the incorrect threshold for detection. The newly derived thresholds for ALT in boys and girls, if applied, will greatly improve the rate of detecting NAFLD (Gastroenterology 2010;138:1357-64).

Fatty liver disease is important because a small subset of children will develop cirrhosis and end-stage liver disease. As if that was not enough, data from a large study of overweight children with and without NAFLD, showed that having fatty liver is an important risk factor for developing type 2 diabetes and cardiovascular disease (Circulation 2008;118:277-83).

There is no doubt that, since the guidelines have come out, there is a greater level of awareness among primary care providers about the risk of liver disease in overweight and obese children. However, the resulting level of action is still not where it needs to be. More attention needs to be paid toward providing guidance and resources to primary care physicians once they do identify a young patient with NAFLD.

JEFFREY B. SCHWIMMER, M.D., is director of the Fatty Liver Clinic at Rady Children's Hospital in San Diego. He reported having no conflicts of interest.

Major Finding: Nonalcoholic fatty liver disease in obese children, adolescents, and young adults was twice as high among males as females, with 27% vs. 13% having ALT levels above 40 IU/L. The NAFLD prevalence increased with age in males but decreased with age in females.

Data Source: A prospective, cross-sectional study of 156 obese youth aged 5-20 years.

Disclosures: Dr. Gupta stated that he had no conflicts of interest.

BOSTON — Nonalcoholic fatty liver disease was found in nearly 1 in 5 of 156 obese children and young adults aged 5-20 years in a cross-sectional analysis.

In the study—the first to assess the prevalence of nonalcoholic fatty liver disease (NAFLD) in obese children by sex and age—more than half of the males aged 16-20 years had NAFLD. “Obesity in children is not a cosmetic disease. There are real complications,” Dr. Rishi Gupta reported at the meeting.

The findings suggest that liver function testing should be considered in obese children with dyslipidemia and/or insulin resistance, said Dr. Gupta, a pediatric endocrinology fellow at the State University of New York Downstate Medical Center, Brooklyn.

The multiethnic group of 86 females and 70 males all had body mass indexes (BMIs) greater than the 95th percentile, but did not have diabetes, abnormal thyroid function, or liver disease due to hepatitis or Wilson's disease. A total of 30 (19%) had levels of alanine aminotransferase (ALT) greater than 40 IU/L, generally considered the cutoff to indicate NAFLD. More recently, cutoffs of greater than 30 IU/L for males and 19 IU/L for females are now being used in Europe and in some U.S. labs.

The subjects with elevated ALT did not differ from those with ALT levels at or below 40 IU/L in age (average, 12 years) or BMI (34 kg/m

The prevalence of NAFLD was twice as high in the males as the females, with 27% vs. 13% having ALT levels above 40 IU/L. Males with NAFLD had significantly higher triglycerides than did females with NAFLD (231 vs. 193 mg/dL), and also had lower HDL cholesterol (34 vs. 35 mg/dL). Males and females with NAFLD did not differ significantly with respect to age, BMI, or HOMA-IR.

The prevalence of NAFLD rose with age, from 14.5% for 5- to 10-year-olds to 18% for 11- to 15-year-olds, to 31% for 16- to 20-year-olds. However, when broken down by sex, the prevalence of NAFLD actually dropped with age in the females, from 15.1% in the youngest group to 14.7% in the 11- to 15-year group to 7.1% in the older teens/young adults. In contrast, among males the NAFLD, prevalence rose with age from 13.6% to 24.2% to 53%.

Over half of obese males aged 16-20 years had NAFLD, said Dr. Rishi Gupta.

Source ©Jean Whiteside Photography

My Take

Labs Incorrectly ID ALT Thresholds

The findings by Dr. Gupta and associates are consistent with the existing literature and society guidelines created because of the high rates of NAFLD in overweight and obese children.

The Study of Child and Adolescent Liver Epidemiology was a large autopsy series in a community-wide setting. Based upon liver histology, this study estimated the prevalence of NAFLD at 9.6% in children aged 2-19 years. Moreover, it was demonstrated that fatty liver prevalence increases with age, is higher in boys than girls, and is high in Hispanics and low in African Americans (Pediatrics 2006;118;1388-93).

Three years ago, an expert committee assembled by the Centers for Disease Control and Prevention, the American Medical Association, and 15 health organizations released recommendations on the Assessment, Prevention, and Treatment of Child and Adolescent Overweight and Obesity. Within those guidelines are recommendations that children aged 10 years and older should receive biannual screening for NAFLD if they have a BMI at the 95th percentile or greater (obese) or a BMI between the 85th and 94th percentiles (overweight) and other risk factors. Furthermore, the committee recommended that an ALT or aspartate transaminase (AST) result twice that of normal levels should prompt a consultation with a pediatric hepatologist (Pediatrics 2007;120:S164-92).

Two years ago, the Lawson Wilkins Pediatric Endocrine Society and the Endocrinology Society published guidelines suggesting that obese children, regardless of age, be screened for NAFLD (J. Clin. Endocrinol. Metab. 2008;93:4576-99).

Last month, a new publication from our group showed that ALT is incorrectly interpreted in many children's hospitals throughout the United States. Imagine that a primary care physician keeps up with the latest guidelines and correctly screens a child for liver disease but never knows that the child has liver disease because the electronic medical system does not flag the results with an “H,” because the laboratory is using the incorrect threshold for detection. The newly derived thresholds for ALT in boys and girls, if applied, will greatly improve the rate of detecting NAFLD (Gastroenterology 2010;138:1357-64).

Fatty liver disease is important because a small subset of children will develop cirrhosis and end-stage liver disease. As if that was not enough, data from a large study of overweight children with and without NAFLD, showed that having fatty liver is an important risk factor for developing type 2 diabetes and cardiovascular disease (Circulation 2008;118:277-83).

There is no doubt that, since the guidelines have come out, there is a greater level of awareness among primary care providers about the risk of liver disease in overweight and obese children. However, the resulting level of action is still not where it needs to be. More attention needs to be paid toward providing guidance and resources to primary care physicians once they do identify a young patient with NAFLD.

JEFFREY B. SCHWIMMER, M.D., is director of the Fatty Liver Clinic at Rady Children's Hospital in San Diego. He reported having no conflicts of interest.

Major Finding: Nonalcoholic fatty liver disease in obese children, adolescents, and young adults was twice as high among males as females, with 27% vs. 13% having ALT levels above 40 IU/L. The NAFLD prevalence increased with age in males but decreased with age in females.

Data Source: A prospective, cross-sectional study of 156 obese youth aged 5-20 years.

Disclosures: Dr. Gupta stated that he had no conflicts of interest.

BOSTON — Nonalcoholic fatty liver disease was found in nearly 1 in 5 of 156 obese children and young adults aged 5-20 years in a cross-sectional analysis.

In the study—the first to assess the prevalence of nonalcoholic fatty liver disease (NAFLD) in obese children by sex and age—more than half of the males aged 16-20 years had NAFLD. “Obesity in children is not a cosmetic disease. There are real complications,” Dr. Rishi Gupta reported at the meeting.

The findings suggest that liver function testing should be considered in obese children with dyslipidemia and/or insulin resistance, said Dr. Gupta, a pediatric endocrinology fellow at the State University of New York Downstate Medical Center, Brooklyn.

The multiethnic group of 86 females and 70 males all had body mass indexes (BMIs) greater than the 95th percentile, but did not have diabetes, abnormal thyroid function, or liver disease due to hepatitis or Wilson's disease. A total of 30 (19%) had levels of alanine aminotransferase (ALT) greater than 40 IU/L, generally considered the cutoff to indicate NAFLD. More recently, cutoffs of greater than 30 IU/L for males and 19 IU/L for females are now being used in Europe and in some U.S. labs.

The subjects with elevated ALT did not differ from those with ALT levels at or below 40 IU/L in age (average, 12 years) or BMI (34 kg/m

The prevalence of NAFLD was twice as high in the males as the females, with 27% vs. 13% having ALT levels above 40 IU/L. Males with NAFLD had significantly higher triglycerides than did females with NAFLD (231 vs. 193 mg/dL), and also had lower HDL cholesterol (34 vs. 35 mg/dL). Males and females with NAFLD did not differ significantly with respect to age, BMI, or HOMA-IR.

The prevalence of NAFLD rose with age, from 14.5% for 5- to 10-year-olds to 18% for 11- to 15-year-olds, to 31% for 16- to 20-year-olds. However, when broken down by sex, the prevalence of NAFLD actually dropped with age in the females, from 15.1% in the youngest group to 14.7% in the 11- to 15-year group to 7.1% in the older teens/young adults. In contrast, among males the NAFLD, prevalence rose with age from 13.6% to 24.2% to 53%.

Over half of obese males aged 16-20 years had NAFLD, said Dr. Rishi Gupta.

Source ©Jean Whiteside Photography

My Take

Labs Incorrectly ID ALT Thresholds

The findings by Dr. Gupta and associates are consistent with the existing literature and society guidelines created because of the high rates of NAFLD in overweight and obese children.

The Study of Child and Adolescent Liver Epidemiology was a large autopsy series in a community-wide setting. Based upon liver histology, this study estimated the prevalence of NAFLD at 9.6% in children aged 2-19 years. Moreover, it was demonstrated that fatty liver prevalence increases with age, is higher in boys than girls, and is high in Hispanics and low in African Americans (Pediatrics 2006;118;1388-93).

Three years ago, an expert committee assembled by the Centers for Disease Control and Prevention, the American Medical Association, and 15 health organizations released recommendations on the Assessment, Prevention, and Treatment of Child and Adolescent Overweight and Obesity. Within those guidelines are recommendations that children aged 10 years and older should receive biannual screening for NAFLD if they have a BMI at the 95th percentile or greater (obese) or a BMI between the 85th and 94th percentiles (overweight) and other risk factors. Furthermore, the committee recommended that an ALT or aspartate transaminase (AST) result twice that of normal levels should prompt a consultation with a pediatric hepatologist (Pediatrics 2007;120:S164-92).

Two years ago, the Lawson Wilkins Pediatric Endocrine Society and the Endocrinology Society published guidelines suggesting that obese children, regardless of age, be screened for NAFLD (J. Clin. Endocrinol. Metab. 2008;93:4576-99).

Last month, a new publication from our group showed that ALT is incorrectly interpreted in many children's hospitals throughout the United States. Imagine that a primary care physician keeps up with the latest guidelines and correctly screens a child for liver disease but never knows that the child has liver disease because the electronic medical system does not flag the results with an “H,” because the laboratory is using the incorrect threshold for detection. The newly derived thresholds for ALT in boys and girls, if applied, will greatly improve the rate of detecting NAFLD (Gastroenterology 2010;138:1357-64).

Fatty liver disease is important because a small subset of children will develop cirrhosis and end-stage liver disease. As if that was not enough, data from a large study of overweight children with and without NAFLD, showed that having fatty liver is an important risk factor for developing type 2 diabetes and cardiovascular disease (Circulation 2008;118:277-83).

There is no doubt that, since the guidelines have come out, there is a greater level of awareness among primary care providers about the risk of liver disease in overweight and obese children. However, the resulting level of action is still not where it needs to be. More attention needs to be paid toward providing guidance and resources to primary care physicians once they do identify a young patient with NAFLD.

JEFFREY B. SCHWIMMER, M.D., is director of the Fatty Liver Clinic at Rady Children's Hospital in San Diego. He reported having no conflicts of interest.