Betsy Bates

HONOLULU — Three recent prospective studies—two conducted in the United States and one in Canada—have begun to tease out risk factors that might identify which infants with bronchiolitis are at risk of severe disease.

As the most common disease of the lower respiratory tract in young children, bronchiolitis leads to 100,000 annual hospital admissions, although it has been frustratingly difficult to pinpoint which patients require intensive measures.

Researchers offered some clues in studies presented back to back at the annual meeting of the Pediatric Academic Societies.

A prospective cohort study conducted in 30 U.S. hospitals during two bronchiolitis seasons (2004–2006) found four independent risk factors for ICU admission vs. admission to a regular hospital floor in 1,456 children less than 2 years old.

Dr. Dorothy Damore and coinvestigators of the Multicenter Airway Research Collaboration found that, after adjustment for potential confounders, the following factors predicted severity: age less than 2 months (53% vs. 26%, for an odds ratio of 4.1); inadequate oral intake (53% vs. 31%, OR 3.3); moderate to severe retractions (48% vs. 31%, OR 2.6); prior emergency department visit within the past week (40% vs. 25%, OR 2.2).

Although initial oxygen saturation less than 90% initially emerged as a risk factor for ICU admission, it lost significance during adjustment for other factors.

Respiratory rate was not found to be a predictor for ICU admission in either univariate or multivariate analyses, said Dr. Damore, a pediatric emergency medicine specialist at New York-Presbyterian Hospital and Weill Cornell Medical Center in New York.

Notably, children with chronic medical conditions were included in the analysis.

Dr. Damore said a larger, ongoing study will include virology data in an effort to explore the potential role of infectious etiology in the severity of bronchiolitis.

A second prospective study examining risk factors for severe bronchiolitis was conducted in eight pediatric emergency departments throughout Canada from late 2004 to April 2007.

Among 1,554 infants up to 1 year old admitted with a first episode of bronchiolitis, 35 (2.2%) developed severe bronchiolitis, defined as the need for intubation, apnea, or admission to a pediatric ICU.

No child died during the study, but 5 developed apnea, 10 required intubation, and 31 ultimately needed to be treated in an ICU. The potential for developing severe disease was “not immediately obvious on initial presentation,” said Dr. Amy C. Plint of the departments of pediatrics and emergency medicine at the University of Ottawa on behalf of the Pediatric Emergency Research Canada group.

Just half were initially admitted to the ICU from the emergency department. Seven were sent home and required readmission. Four specific risk factors distinguished the children with the most severe disease, but only age overlapped the characteristics highlighted in the study led by Dr. Damore.

In this analysis, 100% of severe cases were marked by one of the following: Oxygen saturation on room air of less than 88%; heart rate of equal to or more than 180 beats/min; respiratory rate of greater than or equal to 80 breaths/min; age less than 7 weeks (slightly younger than the at-risk group identified by the Damore study).

Oxygen saturation also figured prominently in a study conducted in 20 U.S. emergency departments participating in the Pediatric Emergency Care Applied Research Network.

In this study of 598 children 2–11 months old admitted with a first case of bronchiolitis, oxygen saturation less than 94% and a temperature of greater than or equal to 38° C stood out in a multivariate analysis as the factors most predictive of a prolonged inpatient hospital stay.

Lead author Dr. Howard Corneli emphasized that no criterion stood out as “highly predictive,” with high sensitivity as well as specificity.

“There is no single [predictive] rule for a complex multifactorial disease,” maintained Dr. Corneli, a pediatric emergency medicine specialist at the University of Utah, Salt Lake City.

None of the presenters reported disclosures of financial conflicts of interest with regard to his or her presentation.

HONOLULU — Three recent prospective studies—two conducted in the United States and one in Canada—have begun to tease out risk factors that might identify which infants with bronchiolitis are at risk of severe disease.

As the most common disease of the lower respiratory tract in young children, bronchiolitis leads to 100,000 annual hospital admissions, although it has been frustratingly difficult to pinpoint which patients require intensive measures.

Researchers offered some clues in studies presented back to back at the annual meeting of the Pediatric Academic Societies.

A prospective cohort study conducted in 30 U.S. hospitals during two bronchiolitis seasons (2004–2006) found four independent risk factors for ICU admission vs. admission to a regular hospital floor in 1,456 children less than 2 years old.

Dr. Dorothy Damore and coinvestigators of the Multicenter Airway Research Collaboration found that, after adjustment for potential confounders, the following factors predicted severity: age less than 2 months (53% vs. 26%, for an odds ratio of 4.1); inadequate oral intake (53% vs. 31%, OR 3.3); moderate to severe retractions (48% vs. 31%, OR 2.6); prior emergency department visit within the past week (40% vs. 25%, OR 2.2).

Although initial oxygen saturation less than 90% initially emerged as a risk factor for ICU admission, it lost significance during adjustment for other factors.

Respiratory rate was not found to be a predictor for ICU admission in either univariate or multivariate analyses, said Dr. Damore, a pediatric emergency medicine specialist at New York-Presbyterian Hospital and Weill Cornell Medical Center in New York.

Notably, children with chronic medical conditions were included in the analysis.

Dr. Damore said a larger, ongoing study will include virology data in an effort to explore the potential role of infectious etiology in the severity of bronchiolitis.

A second prospective study examining risk factors for severe bronchiolitis was conducted in eight pediatric emergency departments throughout Canada from late 2004 to April 2007.

Among 1,554 infants up to 1 year old admitted with a first episode of bronchiolitis, 35 (2.2%) developed severe bronchiolitis, defined as the need for intubation, apnea, or admission to a pediatric ICU.

No child died during the study, but 5 developed apnea, 10 required intubation, and 31 ultimately needed to be treated in an ICU. The potential for developing severe disease was “not immediately obvious on initial presentation,” said Dr. Amy C. Plint of the departments of pediatrics and emergency medicine at the University of Ottawa on behalf of the Pediatric Emergency Research Canada group.

Just half were initially admitted to the ICU from the emergency department. Seven were sent home and required readmission. Four specific risk factors distinguished the children with the most severe disease, but only age overlapped the characteristics highlighted in the study led by Dr. Damore.

In this analysis, 100% of severe cases were marked by one of the following: Oxygen saturation on room air of less than 88%; heart rate of equal to or more than 180 beats/min; respiratory rate of greater than or equal to 80 breaths/min; age less than 7 weeks (slightly younger than the at-risk group identified by the Damore study).

Oxygen saturation also figured prominently in a study conducted in 20 U.S. emergency departments participating in the Pediatric Emergency Care Applied Research Network.

In this study of 598 children 2–11 months old admitted with a first case of bronchiolitis, oxygen saturation less than 94% and a temperature of greater than or equal to 38° C stood out in a multivariate analysis as the factors most predictive of a prolonged inpatient hospital stay.

Lead author Dr. Howard Corneli emphasized that no criterion stood out as “highly predictive,” with high sensitivity as well as specificity.

“There is no single [predictive] rule for a complex multifactorial disease,” maintained Dr. Corneli, a pediatric emergency medicine specialist at the University of Utah, Salt Lake City.

None of the presenters reported disclosures of financial conflicts of interest with regard to his or her presentation.

HONOLULU — Three recent prospective studies—two conducted in the United States and one in Canada—have begun to tease out risk factors that might identify which infants with bronchiolitis are at risk of severe disease.

As the most common disease of the lower respiratory tract in young children, bronchiolitis leads to 100,000 annual hospital admissions, although it has been frustratingly difficult to pinpoint which patients require intensive measures.

Researchers offered some clues in studies presented back to back at the annual meeting of the Pediatric Academic Societies.

A prospective cohort study conducted in 30 U.S. hospitals during two bronchiolitis seasons (2004–2006) found four independent risk factors for ICU admission vs. admission to a regular hospital floor in 1,456 children less than 2 years old.

Dr. Dorothy Damore and coinvestigators of the Multicenter Airway Research Collaboration found that, after adjustment for potential confounders, the following factors predicted severity: age less than 2 months (53% vs. 26%, for an odds ratio of 4.1); inadequate oral intake (53% vs. 31%, OR 3.3); moderate to severe retractions (48% vs. 31%, OR 2.6); prior emergency department visit within the past week (40% vs. 25%, OR 2.2).

Although initial oxygen saturation less than 90% initially emerged as a risk factor for ICU admission, it lost significance during adjustment for other factors.

Respiratory rate was not found to be a predictor for ICU admission in either univariate or multivariate analyses, said Dr. Damore, a pediatric emergency medicine specialist at New York-Presbyterian Hospital and Weill Cornell Medical Center in New York.

Notably, children with chronic medical conditions were included in the analysis.

Dr. Damore said a larger, ongoing study will include virology data in an effort to explore the potential role of infectious etiology in the severity of bronchiolitis.

A second prospective study examining risk factors for severe bronchiolitis was conducted in eight pediatric emergency departments throughout Canada from late 2004 to April 2007.

Among 1,554 infants up to 1 year old admitted with a first episode of bronchiolitis, 35 (2.2%) developed severe bronchiolitis, defined as the need for intubation, apnea, or admission to a pediatric ICU.

No child died during the study, but 5 developed apnea, 10 required intubation, and 31 ultimately needed to be treated in an ICU. The potential for developing severe disease was “not immediately obvious on initial presentation,” said Dr. Amy C. Plint of the departments of pediatrics and emergency medicine at the University of Ottawa on behalf of the Pediatric Emergency Research Canada group.

Just half were initially admitted to the ICU from the emergency department. Seven were sent home and required readmission. Four specific risk factors distinguished the children with the most severe disease, but only age overlapped the characteristics highlighted in the study led by Dr. Damore.

In this analysis, 100% of severe cases were marked by one of the following: Oxygen saturation on room air of less than 88%; heart rate of equal to or more than 180 beats/min; respiratory rate of greater than or equal to 80 breaths/min; age less than 7 weeks (slightly younger than the at-risk group identified by the Damore study).

Oxygen saturation also figured prominently in a study conducted in 20 U.S. emergency departments participating in the Pediatric Emergency Care Applied Research Network.

In this study of 598 children 2–11 months old admitted with a first case of bronchiolitis, oxygen saturation less than 94% and a temperature of greater than or equal to 38° C stood out in a multivariate analysis as the factors most predictive of a prolonged inpatient hospital stay.

Lead author Dr. Howard Corneli emphasized that no criterion stood out as “highly predictive,” with high sensitivity as well as specificity.

“There is no single [predictive] rule for a complex multifactorial disease,” maintained Dr. Corneli, a pediatric emergency medicine specialist at the University of Utah, Salt Lake City.

None of the presenters reported disclosures of financial conflicts of interest with regard to his or her presentation.

SAN DIEGO — Melanoma proved genetically distinguishable from atypical nevi when cells were collected from the stratum corneum using a custom-designed adhesive tape in a poster presentation at the annual meeting of the American Association for Cancer Research.

Molecular analysis of tape-collected RNA identified an expression pattern of 20 genes that was 100% sensitive, 90.6% specific, and 92.4% accurate in detecting both in situ and invasive melanoma in 66 skin samples, reported Dr. William Wachsman of the oncology/hematology division of the University of California, San Diego.

If confirmed in further studies, the technique could be used to obtain a skin sample “noninvasively and painlessly” and to receive an objective diagnosis based on a validated genetic biomarker. “This technique could become the preferred first line for evaluating pigmented lesions suspicious for melanoma,” Dr. Wachsman said in an interview.

The 20-gene cluster used to develop the Epidermal Genetic Information Retrieval (EGIR) system (DermTech International) was selected from an original array of 350 differentially expressed genes put to the test in a preliminary comparison of 18 lesions that proved to be melanoma and 18 ultimately diagnosed as atypical nevi.

In both the preliminary study and the 66-sample testing set, suspicious pigmented lesions and normal skin regions were tape stripped four times using EGIR-specific adhesive film designed by DermTech scientists. Total RNA was then isolated from the tape strips and amplified using microarray technology.

The resulting pattern analysis could distinguish melanomas from normal skin samples as well as from atypical nevi. Furthermore, at least three distinctive groups of atypical nevi were discernable, suggesting the potential of characterizing low- and high-grade nevi.

The finding could have significant diagnostic implications, reducing the number of unnecessary skin biopsies and taking some of the guesswork out of melanoma identification, said Dr. Harold Rabinovitz, a coauthor on the study and a dermatologist in private practice in Plantation, Fla.

Currently, dermatologists can distinguish melanoma from an atypical nevi with about 60% accuracy. The levels of sensitivity and specificity obtained in the study, 100% and 90.6%, respectively, are “very, very high, and exciting,” Dr. Rabinowitz said in an interview.

“The plan is for the RNA samples obtained via EGIR-based tape stripping to be sent to a CLIA [Clinical Laboratory Improvement Amendments] lab for testing. In 3–5 days, the physician will receive a report back that, based on genetic profiling, shows the probability of the lesion in question being a melanoma,” he said.

The company plans to develop a point-of-care application of the technology, so that results would be available while the patient waits in the physician's office.

Dr. Wachsman is an uncompensated adviser to DermTech. Dr. Rabinovitz disclosed that he is a consultant, independent contractor, and advisory board member for DermTech. He also serves as a consultant, medical coordinator, and/or clinical investigator for other technologies aimed at melanoma diagnosis. The first author on the study was Dr. Sherman Chang, director of molecular biology for DermTech in San Diego.

SAN DIEGO — Melanoma proved genetically distinguishable from atypical nevi when cells were collected from the stratum corneum using a custom-designed adhesive tape in a poster presentation at the annual meeting of the American Association for Cancer Research.

Molecular analysis of tape-collected RNA identified an expression pattern of 20 genes that was 100% sensitive, 90.6% specific, and 92.4% accurate in detecting both in situ and invasive melanoma in 66 skin samples, reported Dr. William Wachsman of the oncology/hematology division of the University of California, San Diego.

If confirmed in further studies, the technique could be used to obtain a skin sample “noninvasively and painlessly” and to receive an objective diagnosis based on a validated genetic biomarker. “This technique could become the preferred first line for evaluating pigmented lesions suspicious for melanoma,” Dr. Wachsman said in an interview.

The 20-gene cluster used to develop the Epidermal Genetic Information Retrieval (EGIR) system (DermTech International) was selected from an original array of 350 differentially expressed genes put to the test in a preliminary comparison of 18 lesions that proved to be melanoma and 18 ultimately diagnosed as atypical nevi.

In both the preliminary study and the 66-sample testing set, suspicious pigmented lesions and normal skin regions were tape stripped four times using EGIR-specific adhesive film designed by DermTech scientists. Total RNA was then isolated from the tape strips and amplified using microarray technology.

The resulting pattern analysis could distinguish melanomas from normal skin samples as well as from atypical nevi. Furthermore, at least three distinctive groups of atypical nevi were discernable, suggesting the potential of characterizing low- and high-grade nevi.

The finding could have significant diagnostic implications, reducing the number of unnecessary skin biopsies and taking some of the guesswork out of melanoma identification, said Dr. Harold Rabinovitz, a coauthor on the study and a dermatologist in private practice in Plantation, Fla.

Currently, dermatologists can distinguish melanoma from an atypical nevi with about 60% accuracy. The levels of sensitivity and specificity obtained in the study, 100% and 90.6%, respectively, are “very, very high, and exciting,” Dr. Rabinowitz said in an interview.

“The plan is for the RNA samples obtained via EGIR-based tape stripping to be sent to a CLIA [Clinical Laboratory Improvement Amendments] lab for testing. In 3–5 days, the physician will receive a report back that, based on genetic profiling, shows the probability of the lesion in question being a melanoma,” he said.

The company plans to develop a point-of-care application of the technology, so that results would be available while the patient waits in the physician's office.

Dr. Wachsman is an uncompensated adviser to DermTech. Dr. Rabinovitz disclosed that he is a consultant, independent contractor, and advisory board member for DermTech. He also serves as a consultant, medical coordinator, and/or clinical investigator for other technologies aimed at melanoma diagnosis. The first author on the study was Dr. Sherman Chang, director of molecular biology for DermTech in San Diego.

SAN DIEGO — Melanoma proved genetically distinguishable from atypical nevi when cells were collected from the stratum corneum using a custom-designed adhesive tape in a poster presentation at the annual meeting of the American Association for Cancer Research.

Molecular analysis of tape-collected RNA identified an expression pattern of 20 genes that was 100% sensitive, 90.6% specific, and 92.4% accurate in detecting both in situ and invasive melanoma in 66 skin samples, reported Dr. William Wachsman of the oncology/hematology division of the University of California, San Diego.

If confirmed in further studies, the technique could be used to obtain a skin sample “noninvasively and painlessly” and to receive an objective diagnosis based on a validated genetic biomarker. “This technique could become the preferred first line for evaluating pigmented lesions suspicious for melanoma,” Dr. Wachsman said in an interview.

The 20-gene cluster used to develop the Epidermal Genetic Information Retrieval (EGIR) system (DermTech International) was selected from an original array of 350 differentially expressed genes put to the test in a preliminary comparison of 18 lesions that proved to be melanoma and 18 ultimately diagnosed as atypical nevi.

In both the preliminary study and the 66-sample testing set, suspicious pigmented lesions and normal skin regions were tape stripped four times using EGIR-specific adhesive film designed by DermTech scientists. Total RNA was then isolated from the tape strips and amplified using microarray technology.

The resulting pattern analysis could distinguish melanomas from normal skin samples as well as from atypical nevi. Furthermore, at least three distinctive groups of atypical nevi were discernable, suggesting the potential of characterizing low- and high-grade nevi.

The finding could have significant diagnostic implications, reducing the number of unnecessary skin biopsies and taking some of the guesswork out of melanoma identification, said Dr. Harold Rabinovitz, a coauthor on the study and a dermatologist in private practice in Plantation, Fla.

Currently, dermatologists can distinguish melanoma from an atypical nevi with about 60% accuracy. The levels of sensitivity and specificity obtained in the study, 100% and 90.6%, respectively, are “very, very high, and exciting,” Dr. Rabinowitz said in an interview.

“The plan is for the RNA samples obtained via EGIR-based tape stripping to be sent to a CLIA [Clinical Laboratory Improvement Amendments] lab for testing. In 3–5 days, the physician will receive a report back that, based on genetic profiling, shows the probability of the lesion in question being a melanoma,” he said.

The company plans to develop a point-of-care application of the technology, so that results would be available while the patient waits in the physician's office.

Dr. Wachsman is an uncompensated adviser to DermTech. Dr. Rabinovitz disclosed that he is a consultant, independent contractor, and advisory board member for DermTech. He also serves as a consultant, medical coordinator, and/or clinical investigator for other technologies aimed at melanoma diagnosis. The first author on the study was Dr. Sherman Chang, director of molecular biology for DermTech in San Diego.

DENVER — Harmful adverse events occur in hospitalized infants and children at alarming rates, according to a series of studies that go beyond incident reports to identify errors from patient charts.

When Dr. Paul Sharek and his associates used “trigger tools” to examine data in pediatric patient charts, they found the following:

▸ There were 11.1 adverse drug events per 100 admissions to 12 children's hospitals in the United States (Pediatrics 2008;121:e927-35).

▸ There were 74 adverse drug and nondrug events per 100 admissions to North American neonatal intensive care units, 56% of which were deemed preventable (Pediatrics 2006;118:1332-40).

▸ There were 1,488 errors in 734 patients admitted to pediatric intensive care units, averaging two harmful events per patient (in press).

“Basically, 1 out of every 4 days [of hospitalization], a child gets hurt,” Dr. Sharek said at a meeting on pediatric hospital medicine sponsored by the Society of Hospital Medicine, the Academic Pediatric Association, and the American Academy of Pediatrics.

“I thought this was earth-shattering news,” said Dr. Sharek of data collected for three studies of inpatient safety in pediatrics.

Historically, most studies of safety in pediatric inpatient care were based largely on incident reports, most often focusing on medication errors.

While Dr. Sharek said that such errors are estimated to result in more than 4,000 deaths and cost more than $1 billion a year, these officially documented mistakes barely “scratch the surface” of harmful events.

“The tip of the iceberg [analogy] is really relevant here,” said Dr. Sharek, medical director of quality management and chief clinical patient safety officer at Lucile Packard Children's Hospital of Stanford University in Palo Alto, Calif.

In looking at drug errors alone, the new methodology captured a health care reliability rate of 101 in properly delivering medications to hospitalized children. This rate equates to 1-2 failures out of 10 opportunities, a proportion considered to be “chaos” in industrial psychology studies.

Ten years into industrywide efforts to reduce hospital errors by focusing on “top offender” medical mistakes, “we probably haven't done squat,” said Dr. Sharek.

That's because targeting only high-end errors—an approach he likened to “putting out fires”—misses the critical day-to-day mistakes that cripple an institution's overall safety profile and compromise patient care.

Admittedly, not all errors are life threatening, but a shift in focus to overall systems that preclude mistakes will undoubtedly save many lives and millions of dollars, he said.

“It is time for us to think about a new paradigm,” he asserted.

By drawing on lessons from reliability science used in industry, medical professionals can shift the way errors are identified, examined, and corrected in a systematic way.

For example, instead of blaming a 10-fold overdose on a “dumb resident who was up all night,” reliability science encourages a broader look at conditions that allowed for the error and that leave open the possibility of the error being repeated.

“Look deeper … at multiple system points set up to fail,” he said.

This examination might include an analysis of workforce responsibilities, work hours, communication, drug labeling, pharmacy dispensing, and checks and balances within the system.

Organizations with high rates of reliability have in common a preoccupation with failure, large and small.

“Avoid complacency,” he said. “You look everywhere for failure. You can't sweep it under the rug.”

He cited as an example frequent mix-ups of stored mothers' breast milk given to infants at his institution. “It used to be that the nurses would say, 'What's the big deal?'” when such an error occurred, because mother's milk is frequently banked for use by other infants, anyway.

In fact, a system that accommodates errors is dysfunctional in a larger way, without standardized procedures in place to methodically prevent mistakes—be they in breast milk distribution or heparin administration.

Another way health care institutions can improve their safety margins is to incorporate a “stop the line” policy first introduced in factories, whereby any employee who sees an error is empowered to immediately identify it and ensure that it is corrected.

That means that a nurse or a surgical technician can put the brakes on “the world-class cardiothoracic surgeon who loves to suture chest tubes without gloves.”

Dr. Sharek reported no financial disclosures.

DENVER — Harmful adverse events occur in hospitalized infants and children at alarming rates, according to a series of studies that go beyond incident reports to identify errors from patient charts.

When Dr. Paul Sharek and his associates used “trigger tools” to examine data in pediatric patient charts, they found the following:

▸ There were 11.1 adverse drug events per 100 admissions to 12 children's hospitals in the United States (Pediatrics 2008;121:e927-35).

▸ There were 74 adverse drug and nondrug events per 100 admissions to North American neonatal intensive care units, 56% of which were deemed preventable (Pediatrics 2006;118:1332-40).

▸ There were 1,488 errors in 734 patients admitted to pediatric intensive care units, averaging two harmful events per patient (in press).

“Basically, 1 out of every 4 days [of hospitalization], a child gets hurt,” Dr. Sharek said at a meeting on pediatric hospital medicine sponsored by the Society of Hospital Medicine, the Academic Pediatric Association, and the American Academy of Pediatrics.

“I thought this was earth-shattering news,” said Dr. Sharek of data collected for three studies of inpatient safety in pediatrics.

Historically, most studies of safety in pediatric inpatient care were based largely on incident reports, most often focusing on medication errors.

While Dr. Sharek said that such errors are estimated to result in more than 4,000 deaths and cost more than $1 billion a year, these officially documented mistakes barely “scratch the surface” of harmful events.

“The tip of the iceberg [analogy] is really relevant here,” said Dr. Sharek, medical director of quality management and chief clinical patient safety officer at Lucile Packard Children's Hospital of Stanford University in Palo Alto, Calif.

In looking at drug errors alone, the new methodology captured a health care reliability rate of 101 in properly delivering medications to hospitalized children. This rate equates to 1-2 failures out of 10 opportunities, a proportion considered to be “chaos” in industrial psychology studies.

Ten years into industrywide efforts to reduce hospital errors by focusing on “top offender” medical mistakes, “we probably haven't done squat,” said Dr. Sharek.

That's because targeting only high-end errors—an approach he likened to “putting out fires”—misses the critical day-to-day mistakes that cripple an institution's overall safety profile and compromise patient care.

Admittedly, not all errors are life threatening, but a shift in focus to overall systems that preclude mistakes will undoubtedly save many lives and millions of dollars, he said.

“It is time for us to think about a new paradigm,” he asserted.

By drawing on lessons from reliability science used in industry, medical professionals can shift the way errors are identified, examined, and corrected in a systematic way.

For example, instead of blaming a 10-fold overdose on a “dumb resident who was up all night,” reliability science encourages a broader look at conditions that allowed for the error and that leave open the possibility of the error being repeated.

“Look deeper … at multiple system points set up to fail,” he said.

This examination might include an analysis of workforce responsibilities, work hours, communication, drug labeling, pharmacy dispensing, and checks and balances within the system.

Organizations with high rates of reliability have in common a preoccupation with failure, large and small.

“Avoid complacency,” he said. “You look everywhere for failure. You can't sweep it under the rug.”

He cited as an example frequent mix-ups of stored mothers' breast milk given to infants at his institution. “It used to be that the nurses would say, 'What's the big deal?'” when such an error occurred, because mother's milk is frequently banked for use by other infants, anyway.

In fact, a system that accommodates errors is dysfunctional in a larger way, without standardized procedures in place to methodically prevent mistakes—be they in breast milk distribution or heparin administration.

Another way health care institutions can improve their safety margins is to incorporate a “stop the line” policy first introduced in factories, whereby any employee who sees an error is empowered to immediately identify it and ensure that it is corrected.

That means that a nurse or a surgical technician can put the brakes on “the world-class cardiothoracic surgeon who loves to suture chest tubes without gloves.”

Dr. Sharek reported no financial disclosures.

DENVER — Harmful adverse events occur in hospitalized infants and children at alarming rates, according to a series of studies that go beyond incident reports to identify errors from patient charts.

When Dr. Paul Sharek and his associates used “trigger tools” to examine data in pediatric patient charts, they found the following:

▸ There were 11.1 adverse drug events per 100 admissions to 12 children's hospitals in the United States (Pediatrics 2008;121:e927-35).

▸ There were 74 adverse drug and nondrug events per 100 admissions to North American neonatal intensive care units, 56% of which were deemed preventable (Pediatrics 2006;118:1332-40).

▸ There were 1,488 errors in 734 patients admitted to pediatric intensive care units, averaging two harmful events per patient (in press).

“Basically, 1 out of every 4 days [of hospitalization], a child gets hurt,” Dr. Sharek said at a meeting on pediatric hospital medicine sponsored by the Society of Hospital Medicine, the Academic Pediatric Association, and the American Academy of Pediatrics.

“I thought this was earth-shattering news,” said Dr. Sharek of data collected for three studies of inpatient safety in pediatrics.

Historically, most studies of safety in pediatric inpatient care were based largely on incident reports, most often focusing on medication errors.

While Dr. Sharek said that such errors are estimated to result in more than 4,000 deaths and cost more than $1 billion a year, these officially documented mistakes barely “scratch the surface” of harmful events.

“The tip of the iceberg [analogy] is really relevant here,” said Dr. Sharek, medical director of quality management and chief clinical patient safety officer at Lucile Packard Children's Hospital of Stanford University in Palo Alto, Calif.

In looking at drug errors alone, the new methodology captured a health care reliability rate of 101 in properly delivering medications to hospitalized children. This rate equates to 1-2 failures out of 10 opportunities, a proportion considered to be “chaos” in industrial psychology studies.

Ten years into industrywide efforts to reduce hospital errors by focusing on “top offender” medical mistakes, “we probably haven't done squat,” said Dr. Sharek.

That's because targeting only high-end errors—an approach he likened to “putting out fires”—misses the critical day-to-day mistakes that cripple an institution's overall safety profile and compromise patient care.

Admittedly, not all errors are life threatening, but a shift in focus to overall systems that preclude mistakes will undoubtedly save many lives and millions of dollars, he said.

“It is time for us to think about a new paradigm,” he asserted.

By drawing on lessons from reliability science used in industry, medical professionals can shift the way errors are identified, examined, and corrected in a systematic way.

For example, instead of blaming a 10-fold overdose on a “dumb resident who was up all night,” reliability science encourages a broader look at conditions that allowed for the error and that leave open the possibility of the error being repeated.

“Look deeper … at multiple system points set up to fail,” he said.

This examination might include an analysis of workforce responsibilities, work hours, communication, drug labeling, pharmacy dispensing, and checks and balances within the system.

Organizations with high rates of reliability have in common a preoccupation with failure, large and small.

“Avoid complacency,” he said. “You look everywhere for failure. You can't sweep it under the rug.”

He cited as an example frequent mix-ups of stored mothers' breast milk given to infants at his institution. “It used to be that the nurses would say, 'What's the big deal?'” when such an error occurred, because mother's milk is frequently banked for use by other infants, anyway.

In fact, a system that accommodates errors is dysfunctional in a larger way, without standardized procedures in place to methodically prevent mistakes—be they in breast milk distribution or heparin administration.

Another way health care institutions can improve their safety margins is to incorporate a “stop the line” policy first introduced in factories, whereby any employee who sees an error is empowered to immediately identify it and ensure that it is corrected.

That means that a nurse or a surgical technician can put the brakes on “the world-class cardiothoracic surgeon who loves to suture chest tubes without gloves.”

Dr. Sharek reported no financial disclosures.

LAS VEGAS — An evolving understanding of the pathogenesis of calciphylaxis in hospitalized patients may lead to antithrombotic treatment strategies focused on vascular occlusion as well as dialysis- and parathyroid-specific interventions.

“Calciphylaxis is a therapeutic conundrum and also a nightmare,” said Dr. Mark D.P. Davis, professor of dermatology at the Mayo Clinic, Rochester, Minn.

“We urgently need better treatment and preventive strategies,” he stressed at a dermatology seminar sponsored by Skin Disease Education Foundation.

The condition's name, calciphylaxis, reflects an early belief that the introduction of a certain agent (likely during dialysis) induced calcification of vessels, a notion now disputed since the disease can occur in patients without renal insufficiency.

A more accurate name, first proposed by Dr. Patrick Dahl and his associates, is the vascular calcification-cutaneous necrosis syndrome (J. Am. Acad. Dermatol. 1995;33:53–8), which better characterizes calciphylaxis as “akin to a myocardial infarction,” Dr. Davis said. Calcifications in the walls of small arterioles supplying the skin are the first evidence of the disorder. The resultant clots trigger skin infarctions, just as a blockage of a vessel leads to an MI.

Treatment at Mayo focuses on vascular occlusion, along with management of hypercalcemia (with low-calcium dialysate and sodium thiosulfate in dialysis patients), hyperphosphatemia (with phosphate binding agents), hyperparathyroidism (with cinacalcet and bisphosphonates), and pain.

“It's very important to treat vascular occlusions and eliminate these luminal thromboses causing this cutaneous infarct,” he said. “One way to treat an existing clot is to use thrombolytic agents.”

Several Mayo Clinic patients have been treated with infused tissue plasminogen activator (tPA) at doses 1/10 of those used to treat an MI. Because of concern over bleeding, patients are admitted for the 2-week procedure. “We have had some success and are presently reviewing our experience with this approach,” Dr. Davis said.

Anticoagulant medications, including heparin, low-molecular-weight heparin, and warfarin, are also employed so that calciphylaxis patients don't clot more.

Hyperbaric oxygen, which enhances tissue oxygenation and induces vascular neogenesis (and may increase fibrinolytic activity within endothelial cells) also makes sense in the context of calciphylaxis as a disease of vascular calcification/cutaneous infarction.

Dr. M.R. (Pete) Hayden, a calciphylaxis researcher who has published several studies on sodium thiosulfate as a possible treatment, commented later that he is “looking forward excitedly to future papers” on the anticoagulant approach from Dr. Davis and Mayo researchers.

“Indeed, thrombolytic agents may be an important adjunctive intervention along with calcium-chelating agents and phosphate binding agents in appropriate patients because there are so many precipitating variables important to the development of calciphylaxis,” said Dr. Hayden, research professor of internal medicine in the division of endocrinology, diabetes, and metabolism at the University of Missouri, Camdenton.

Other interventions have not fared as well. A comprehensive review of 64 patients treated at the Mayo Clinic failed to find any survival benefit with parathyroidectomy, despite case studies and series that have suggested the surgery is beneficial (J. Am. Acad. Dermatol. 2007;57:365–6).

Debridement was associated with a 1-year survival rate of 62%, versus 27% survival rates in patients who failed to undergo the procedure. Surgical and mechanical debridement are difficult to perform in patients with this “excruciatingly painful” disease, so painless debridement using maggots and ultrasound is being utilized at Mayo, to good effect, Dr. Davis said.

A population-based study conducted in the Rochester area found an incidence of 4.5 cases per million people, per year. About 1% of patients with chronic renal failure and 4% of dialysis patients reportedly have the disease.

Renal insufficiency characterizes the “vast majority” of patients with calciphylaxis, but many patients seen at the Mayo Clinic have underlying liver disease and no history of kidney failure, Dr. Davis noted.

Other findings in patients (with or without renal insufficiency) include hyper- or hypoparathyroidism, calcium-phosphate product greater than 70, obesity (body mass index greater than 30), systemic corticosteroid use, vitamin D deficiency, bone disease, systemic inflammatory state, and malignancy, especially bone metastasis.

SDEF and this news organization are owned by Elsevier.

LAS VEGAS — An evolving understanding of the pathogenesis of calciphylaxis in hospitalized patients may lead to antithrombotic treatment strategies focused on vascular occlusion as well as dialysis- and parathyroid-specific interventions.

“Calciphylaxis is a therapeutic conundrum and also a nightmare,” said Dr. Mark D.P. Davis, professor of dermatology at the Mayo Clinic, Rochester, Minn.

“We urgently need better treatment and preventive strategies,” he stressed at a dermatology seminar sponsored by Skin Disease Education Foundation.

The condition's name, calciphylaxis, reflects an early belief that the introduction of a certain agent (likely during dialysis) induced calcification of vessels, a notion now disputed since the disease can occur in patients without renal insufficiency.

A more accurate name, first proposed by Dr. Patrick Dahl and his associates, is the vascular calcification-cutaneous necrosis syndrome (J. Am. Acad. Dermatol. 1995;33:53–8), which better characterizes calciphylaxis as “akin to a myocardial infarction,” Dr. Davis said. Calcifications in the walls of small arterioles supplying the skin are the first evidence of the disorder. The resultant clots trigger skin infarctions, just as a blockage of a vessel leads to an MI.

Treatment at Mayo focuses on vascular occlusion, along with management of hypercalcemia (with low-calcium dialysate and sodium thiosulfate in dialysis patients), hyperphosphatemia (with phosphate binding agents), hyperparathyroidism (with cinacalcet and bisphosphonates), and pain.

“It's very important to treat vascular occlusions and eliminate these luminal thromboses causing this cutaneous infarct,” he said. “One way to treat an existing clot is to use thrombolytic agents.”

Several Mayo Clinic patients have been treated with infused tissue plasminogen activator (tPA) at doses 1/10 of those used to treat an MI. Because of concern over bleeding, patients are admitted for the 2-week procedure. “We have had some success and are presently reviewing our experience with this approach,” Dr. Davis said.

Anticoagulant medications, including heparin, low-molecular-weight heparin, and warfarin, are also employed so that calciphylaxis patients don't clot more.

Hyperbaric oxygen, which enhances tissue oxygenation and induces vascular neogenesis (and may increase fibrinolytic activity within endothelial cells) also makes sense in the context of calciphylaxis as a disease of vascular calcification/cutaneous infarction.

Dr. M.R. (Pete) Hayden, a calciphylaxis researcher who has published several studies on sodium thiosulfate as a possible treatment, commented later that he is “looking forward excitedly to future papers” on the anticoagulant approach from Dr. Davis and Mayo researchers.

“Indeed, thrombolytic agents may be an important adjunctive intervention along with calcium-chelating agents and phosphate binding agents in appropriate patients because there are so many precipitating variables important to the development of calciphylaxis,” said Dr. Hayden, research professor of internal medicine in the division of endocrinology, diabetes, and metabolism at the University of Missouri, Camdenton.

Other interventions have not fared as well. A comprehensive review of 64 patients treated at the Mayo Clinic failed to find any survival benefit with parathyroidectomy, despite case studies and series that have suggested the surgery is beneficial (J. Am. Acad. Dermatol. 2007;57:365–6).

Debridement was associated with a 1-year survival rate of 62%, versus 27% survival rates in patients who failed to undergo the procedure. Surgical and mechanical debridement are difficult to perform in patients with this “excruciatingly painful” disease, so painless debridement using maggots and ultrasound is being utilized at Mayo, to good effect, Dr. Davis said.

A population-based study conducted in the Rochester area found an incidence of 4.5 cases per million people, per year. About 1% of patients with chronic renal failure and 4% of dialysis patients reportedly have the disease.

Renal insufficiency characterizes the “vast majority” of patients with calciphylaxis, but many patients seen at the Mayo Clinic have underlying liver disease and no history of kidney failure, Dr. Davis noted.

Other findings in patients (with or without renal insufficiency) include hyper- or hypoparathyroidism, calcium-phosphate product greater than 70, obesity (body mass index greater than 30), systemic corticosteroid use, vitamin D deficiency, bone disease, systemic inflammatory state, and malignancy, especially bone metastasis.

SDEF and this news organization are owned by Elsevier.

LAS VEGAS — An evolving understanding of the pathogenesis of calciphylaxis in hospitalized patients may lead to antithrombotic treatment strategies focused on vascular occlusion as well as dialysis- and parathyroid-specific interventions.

“Calciphylaxis is a therapeutic conundrum and also a nightmare,” said Dr. Mark D.P. Davis, professor of dermatology at the Mayo Clinic, Rochester, Minn.

“We urgently need better treatment and preventive strategies,” he stressed at a dermatology seminar sponsored by Skin Disease Education Foundation.

The condition's name, calciphylaxis, reflects an early belief that the introduction of a certain agent (likely during dialysis) induced calcification of vessels, a notion now disputed since the disease can occur in patients without renal insufficiency.

A more accurate name, first proposed by Dr. Patrick Dahl and his associates, is the vascular calcification-cutaneous necrosis syndrome (J. Am. Acad. Dermatol. 1995;33:53–8), which better characterizes calciphylaxis as “akin to a myocardial infarction,” Dr. Davis said. Calcifications in the walls of small arterioles supplying the skin are the first evidence of the disorder. The resultant clots trigger skin infarctions, just as a blockage of a vessel leads to an MI.

Treatment at Mayo focuses on vascular occlusion, along with management of hypercalcemia (with low-calcium dialysate and sodium thiosulfate in dialysis patients), hyperphosphatemia (with phosphate binding agents), hyperparathyroidism (with cinacalcet and bisphosphonates), and pain.

“It's very important to treat vascular occlusions and eliminate these luminal thromboses causing this cutaneous infarct,” he said. “One way to treat an existing clot is to use thrombolytic agents.”

Several Mayo Clinic patients have been treated with infused tissue plasminogen activator (tPA) at doses 1/10 of those used to treat an MI. Because of concern over bleeding, patients are admitted for the 2-week procedure. “We have had some success and are presently reviewing our experience with this approach,” Dr. Davis said.

Anticoagulant medications, including heparin, low-molecular-weight heparin, and warfarin, are also employed so that calciphylaxis patients don't clot more.

Hyperbaric oxygen, which enhances tissue oxygenation and induces vascular neogenesis (and may increase fibrinolytic activity within endothelial cells) also makes sense in the context of calciphylaxis as a disease of vascular calcification/cutaneous infarction.

Dr. M.R. (Pete) Hayden, a calciphylaxis researcher who has published several studies on sodium thiosulfate as a possible treatment, commented later that he is “looking forward excitedly to future papers” on the anticoagulant approach from Dr. Davis and Mayo researchers.

“Indeed, thrombolytic agents may be an important adjunctive intervention along with calcium-chelating agents and phosphate binding agents in appropriate patients because there are so many precipitating variables important to the development of calciphylaxis,” said Dr. Hayden, research professor of internal medicine in the division of endocrinology, diabetes, and metabolism at the University of Missouri, Camdenton.

Other interventions have not fared as well. A comprehensive review of 64 patients treated at the Mayo Clinic failed to find any survival benefit with parathyroidectomy, despite case studies and series that have suggested the surgery is beneficial (J. Am. Acad. Dermatol. 2007;57:365–6).

Debridement was associated with a 1-year survival rate of 62%, versus 27% survival rates in patients who failed to undergo the procedure. Surgical and mechanical debridement are difficult to perform in patients with this “excruciatingly painful” disease, so painless debridement using maggots and ultrasound is being utilized at Mayo, to good effect, Dr. Davis said.

A population-based study conducted in the Rochester area found an incidence of 4.5 cases per million people, per year. About 1% of patients with chronic renal failure and 4% of dialysis patients reportedly have the disease.

Renal insufficiency characterizes the “vast majority” of patients with calciphylaxis, but many patients seen at the Mayo Clinic have underlying liver disease and no history of kidney failure, Dr. Davis noted.

Other findings in patients (with or without renal insufficiency) include hyper- or hypoparathyroidism, calcium-phosphate product greater than 70, obesity (body mass index greater than 30), systemic corticosteroid use, vitamin D deficiency, bone disease, systemic inflammatory state, and malignancy, especially bone metastasis.

SDEF and this news organization are owned by Elsevier.

SANTA MONICA, CALIF. — In the early days of cosmetic botulinum toxin type A therapy, rumors greatly outnumbered scientific facts about its safety, storage, and storied effect on furrowed brows and deep crow's feet.

The faculty at a recent cosmetic dermatology seminar sponsored by Skin Disease Education Foundation helped to put some of these myths to rest.

▸ Botox is deadly. Among 28 deaths reported to the Food and Drug Administration from December 1989 to May 2003, none involved cosmetic use of Botox (J. Am. Acad. Dermatol. 2005;53:407–15). Indeed, of 16 deaths recently highlighted by citizens' groups, all involved serious disorders treated with huge volumes of Botox, said Dr. Allan Wirtzer, a dermatologist in private practice in Sherman Oaks, Calif.

Among the potentially deadly uses of Botox is treatment of severe cervical dystonia, which can lead to spread of the toxin to the esophagus, prompting dysphagia or aspiration pneumonia.

▸ Book prewedding Botox sessions on Friday afternoons. Disappointed brides and furious mothers-in-law will blame you for the wedding pictures if you schedule cosmetic procedures too close to the ceremony, said Dr. Mitchell Goldman, a dermatologist in private practice in La Jolla, Calif. Botox's full effect takes 5–6 days, and unexpected bruising may need time to heal.

▸ Avoid freezing. The refrigerator is the place for Botox, but Dr. Richard Glogau, a dermatologist in San Francisco, may have chipped away at the myth that freezing "will degrade the molecule," when Botox that was frozen by mistake worked just fine on his patients, Dr. Goldman said.

▸ Save the paralysis for the muscles. There was a day when patients were told to sit perfectly upright, avoid exercise, and cancel air travel plans for hours after Botox injections. These precautions are "just old wives' tales—such ridiculous stuff," said Dr. Goldman.

Dr. Wirtzer has served as a consultant for Medicis, distributor of Reloxin (botulinum toxin type A, not approved in the United States). Dr. Goldman has received grant support from, and served as a consultant and speaker for, Allergan Inc., maker of Botox.

SDEF and this news organization are wholly owned subsidiaries of Elsevier.

SANTA MONICA, CALIF. — In the early days of cosmetic botulinum toxin type A therapy, rumors greatly outnumbered scientific facts about its safety, storage, and storied effect on furrowed brows and deep crow's feet.

The faculty at a recent cosmetic dermatology seminar sponsored by Skin Disease Education Foundation helped to put some of these myths to rest.

▸ Botox is deadly. Among 28 deaths reported to the Food and Drug Administration from December 1989 to May 2003, none involved cosmetic use of Botox (J. Am. Acad. Dermatol. 2005;53:407–15). Indeed, of 16 deaths recently highlighted by citizens' groups, all involved serious disorders treated with huge volumes of Botox, said Dr. Allan Wirtzer, a dermatologist in private practice in Sherman Oaks, Calif.

Among the potentially deadly uses of Botox is treatment of severe cervical dystonia, which can lead to spread of the toxin to the esophagus, prompting dysphagia or aspiration pneumonia.

▸ Book prewedding Botox sessions on Friday afternoons. Disappointed brides and furious mothers-in-law will blame you for the wedding pictures if you schedule cosmetic procedures too close to the ceremony, said Dr. Mitchell Goldman, a dermatologist in private practice in La Jolla, Calif. Botox's full effect takes 5–6 days, and unexpected bruising may need time to heal.

▸ Avoid freezing. The refrigerator is the place for Botox, but Dr. Richard Glogau, a dermatologist in San Francisco, may have chipped away at the myth that freezing "will degrade the molecule," when Botox that was frozen by mistake worked just fine on his patients, Dr. Goldman said.

▸ Save the paralysis for the muscles. There was a day when patients were told to sit perfectly upright, avoid exercise, and cancel air travel plans for hours after Botox injections. These precautions are "just old wives' tales—such ridiculous stuff," said Dr. Goldman.

Dr. Wirtzer has served as a consultant for Medicis, distributor of Reloxin (botulinum toxin type A, not approved in the United States). Dr. Goldman has received grant support from, and served as a consultant and speaker for, Allergan Inc., maker of Botox.

SDEF and this news organization are wholly owned subsidiaries of Elsevier.

SANTA MONICA, CALIF. — In the early days of cosmetic botulinum toxin type A therapy, rumors greatly outnumbered scientific facts about its safety, storage, and storied effect on furrowed brows and deep crow's feet.

The faculty at a recent cosmetic dermatology seminar sponsored by Skin Disease Education Foundation helped to put some of these myths to rest.

▸ Botox is deadly. Among 28 deaths reported to the Food and Drug Administration from December 1989 to May 2003, none involved cosmetic use of Botox (J. Am. Acad. Dermatol. 2005;53:407–15). Indeed, of 16 deaths recently highlighted by citizens' groups, all involved serious disorders treated with huge volumes of Botox, said Dr. Allan Wirtzer, a dermatologist in private practice in Sherman Oaks, Calif.

Among the potentially deadly uses of Botox is treatment of severe cervical dystonia, which can lead to spread of the toxin to the esophagus, prompting dysphagia or aspiration pneumonia.

▸ Book prewedding Botox sessions on Friday afternoons. Disappointed brides and furious mothers-in-law will blame you for the wedding pictures if you schedule cosmetic procedures too close to the ceremony, said Dr. Mitchell Goldman, a dermatologist in private practice in La Jolla, Calif. Botox's full effect takes 5–6 days, and unexpected bruising may need time to heal.

▸ Avoid freezing. The refrigerator is the place for Botox, but Dr. Richard Glogau, a dermatologist in San Francisco, may have chipped away at the myth that freezing "will degrade the molecule," when Botox that was frozen by mistake worked just fine on his patients, Dr. Goldman said.

▸ Save the paralysis for the muscles. There was a day when patients were told to sit perfectly upright, avoid exercise, and cancel air travel plans for hours after Botox injections. These precautions are "just old wives' tales—such ridiculous stuff," said Dr. Goldman.

Dr. Wirtzer has served as a consultant for Medicis, distributor of Reloxin (botulinum toxin type A, not approved in the United States). Dr. Goldman has received grant support from, and served as a consultant and speaker for, Allergan Inc., maker of Botox.

SDEF and this news organization are wholly owned subsidiaries of Elsevier.

SANTA MONICA, CALIF. — Live video demonstrations of several novel laser and laserlike devices generated mixed reviews from a panel of dermatologists.

Panelists at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation disagreed about the safety and efficacy of several of the devices, although they came to a meeting of the minds on some points, such as the "feel-good" potential of microdermabrasion devices.

What follows is a recap of many of the thumbs-up, thumbs-down impressions aired at the meeting.

Portrait Plasma

"I have to say I'm truly impressed with this device," said Dr. Christopher Zachary, professor and chair of dermatology at the University of California, Irvine.

"I'm not sure why it hasn't caught on."

The Portrait Plasma device, manufactured by Rhytec, derives its heat energy from nitrogen plasma rather than from a laser.

Treatment of photodamage, including fine lines and wrinkles, is attained by using a variety of energy levels up to 5–6 J, a setting that leaves behind significant erythema.

At about 4 J, the epidermis appears bronzed, with the skin remaining intact for several days "like a natural dressing," Dr. Zachary said.

Dr. Mitchel P. Goldman, a dermatologist in private practice in La Jolla, Calif., expressed concern about the variability of the energy delivery.

"I've seen profound scarring with this device," he said. "I prefer a laser where I know exactly how much heat is going to be built up between each pass."

Dr. Zachary agreed that "there is no free lunch" with the Portrait Plasma. Double passes at 3.5–4 J could definitely produce scarring, although the device also has the potential for significant improvement in the skin, he said.

"Share [the potential of side effects] with the patient," he suggested. "Let them be part of the decision."

VariLite Laser

Dr. Bill H. Halmi, a Phoenix-based dermatologist, demonstrated the use of the VariLite dual wavelength (532 nm or 940 nm) laser, manufactured by Iridex, as a "spot welding device" that can target unsightly perinasal vessels by creating a dotted line of damage, leaving untreated millimeters of tissue between the spots.

"Go for little gaps" in the visible vessel line, Dr. Zachary said during the live video presentation.

As visual evidence of the vein disappeared under the beam of the laser, Dr. Zachary marveled, "Oh, that's very nice. It's better than sex!"

Dr. Zachary stressed the need for wearing protective goggles, preferably polarized for better visualization, when using the device.

Dr. Goldman offered a less rosy opinion. "This is the single most dangerous procedure to do. It puts holes in peoples' faces," he said.

Whitened skin evident in the video close-ups represents destruction of the epidermis. He also expressed concern that the laser has no epidermal cooling system to prevent permanent heat damage.

Beyond the safety concerns, Dr. Goldman questioned the permanence of the VariLite treatment. Red telangiectasias seen at the nasal alar area originate from the nasolabial artery and "will always come back," he pointed out. "[I would] never, ever tell a patient it's permanent, and I don't think it's better than sex."

DermaSweep

One of a wide variety of dermabrasion devices, DermaSweep (developed by CosMedic) requires no anesthesia and is becoming a popular modality among physicians, said Dr. Zachary.

This particular unit uses suction to draw the skin close to a variety of different bristles that range from "a silky, superficial … polisher to aggressive bristles," he said.

The device is said to enhance penetration of infusions of hyaluronic acid, vitamin C preparations, and Levulan (DUSA Pharmaceuticals Inc.).

"There is no way an infusion of hyaluronic acid is going to do a darned thing beyond 1–2 days," said Dr. Goldman. He also questioned its use in patients with a propensity to develop telangiectasias, such as those with rosacea.

Physicians should understand that if they use it prior to a light peel, the peel will become a deep peel with all of the associated side effects.

This said, Dr. Goldman acknowledged that the DermaSweep is an "outstanding machine" and that he uses it in his spa and on patients receiving photodynamic therapy.

All of the panelists commented on the immediate smoothing created by the low-impact device.

"It feels good for a day," said Dr. Margaret Mann, who is with the department of dermatology at the University of California, Irvine. "You get what you pay for."

She said, however, that she also uses the device to enhance penetration of aminolevulinic acid before photodynamic therapy, and she sees it as a nice introductory procedure. "It's great for the patient who comes in and just wants to know what an aesthetic procedure is like," Dr. Mann said.

Once such a patient feels comfortable, he or she "might move on to something more aggressive," she suggested.

Dr. Zachary disclosed that he has received equipment loans from Rhytec, Iridex, and CosMedic.

Dr. Goldman, Dr. Mann, and Dr. Halmi had no disclosures relating to the products mentioned in this article.

Skin Disease Education Foundation and this news organization are wholly owned subsidiaries of Elsevier.

SANTA MONICA, CALIF. — Live video demonstrations of several novel laser and laserlike devices generated mixed reviews from a panel of dermatologists.

Panelists at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation disagreed about the safety and efficacy of several of the devices, although they came to a meeting of the minds on some points, such as the "feel-good" potential of microdermabrasion devices.

What follows is a recap of many of the thumbs-up, thumbs-down impressions aired at the meeting.

Portrait Plasma

"I have to say I'm truly impressed with this device," said Dr. Christopher Zachary, professor and chair of dermatology at the University of California, Irvine.

"I'm not sure why it hasn't caught on."

The Portrait Plasma device, manufactured by Rhytec, derives its heat energy from nitrogen plasma rather than from a laser.

Treatment of photodamage, including fine lines and wrinkles, is attained by using a variety of energy levels up to 5–6 J, a setting that leaves behind significant erythema.

At about 4 J, the epidermis appears bronzed, with the skin remaining intact for several days "like a natural dressing," Dr. Zachary said.

Dr. Mitchel P. Goldman, a dermatologist in private practice in La Jolla, Calif., expressed concern about the variability of the energy delivery.

"I've seen profound scarring with this device," he said. "I prefer a laser where I know exactly how much heat is going to be built up between each pass."

Dr. Zachary agreed that "there is no free lunch" with the Portrait Plasma. Double passes at 3.5–4 J could definitely produce scarring, although the device also has the potential for significant improvement in the skin, he said.

"Share [the potential of side effects] with the patient," he suggested. "Let them be part of the decision."

VariLite Laser

Dr. Bill H. Halmi, a Phoenix-based dermatologist, demonstrated the use of the VariLite dual wavelength (532 nm or 940 nm) laser, manufactured by Iridex, as a "spot welding device" that can target unsightly perinasal vessels by creating a dotted line of damage, leaving untreated millimeters of tissue between the spots.

"Go for little gaps" in the visible vessel line, Dr. Zachary said during the live video presentation.

As visual evidence of the vein disappeared under the beam of the laser, Dr. Zachary marveled, "Oh, that's very nice. It's better than sex!"

Dr. Zachary stressed the need for wearing protective goggles, preferably polarized for better visualization, when using the device.

Dr. Goldman offered a less rosy opinion. "This is the single most dangerous procedure to do. It puts holes in peoples' faces," he said.

Whitened skin evident in the video close-ups represents destruction of the epidermis. He also expressed concern that the laser has no epidermal cooling system to prevent permanent heat damage.

Beyond the safety concerns, Dr. Goldman questioned the permanence of the VariLite treatment. Red telangiectasias seen at the nasal alar area originate from the nasolabial artery and "will always come back," he pointed out. "[I would] never, ever tell a patient it's permanent, and I don't think it's better than sex."

DermaSweep

One of a wide variety of dermabrasion devices, DermaSweep (developed by CosMedic) requires no anesthesia and is becoming a popular modality among physicians, said Dr. Zachary.

This particular unit uses suction to draw the skin close to a variety of different bristles that range from "a silky, superficial … polisher to aggressive bristles," he said.

The device is said to enhance penetration of infusions of hyaluronic acid, vitamin C preparations, and Levulan (DUSA Pharmaceuticals Inc.).

"There is no way an infusion of hyaluronic acid is going to do a darned thing beyond 1–2 days," said Dr. Goldman. He also questioned its use in patients with a propensity to develop telangiectasias, such as those with rosacea.

Physicians should understand that if they use it prior to a light peel, the peel will become a deep peel with all of the associated side effects.

This said, Dr. Goldman acknowledged that the DermaSweep is an "outstanding machine" and that he uses it in his spa and on patients receiving photodynamic therapy.

All of the panelists commented on the immediate smoothing created by the low-impact device.

"It feels good for a day," said Dr. Margaret Mann, who is with the department of dermatology at the University of California, Irvine. "You get what you pay for."

She said, however, that she also uses the device to enhance penetration of aminolevulinic acid before photodynamic therapy, and she sees it as a nice introductory procedure. "It's great for the patient who comes in and just wants to know what an aesthetic procedure is like," Dr. Mann said.

Once such a patient feels comfortable, he or she "might move on to something more aggressive," she suggested.

Dr. Zachary disclosed that he has received equipment loans from Rhytec, Iridex, and CosMedic.

Dr. Goldman, Dr. Mann, and Dr. Halmi had no disclosures relating to the products mentioned in this article.

Skin Disease Education Foundation and this news organization are wholly owned subsidiaries of Elsevier.

SANTA MONICA, CALIF. — Live video demonstrations of several novel laser and laserlike devices generated mixed reviews from a panel of dermatologists.

Panelists at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation disagreed about the safety and efficacy of several of the devices, although they came to a meeting of the minds on some points, such as the "feel-good" potential of microdermabrasion devices.

What follows is a recap of many of the thumbs-up, thumbs-down impressions aired at the meeting.

Portrait Plasma

"I have to say I'm truly impressed with this device," said Dr. Christopher Zachary, professor and chair of dermatology at the University of California, Irvine.

"I'm not sure why it hasn't caught on."

The Portrait Plasma device, manufactured by Rhytec, derives its heat energy from nitrogen plasma rather than from a laser.

Treatment of photodamage, including fine lines and wrinkles, is attained by using a variety of energy levels up to 5–6 J, a setting that leaves behind significant erythema.

At about 4 J, the epidermis appears bronzed, with the skin remaining intact for several days "like a natural dressing," Dr. Zachary said.

Dr. Mitchel P. Goldman, a dermatologist in private practice in La Jolla, Calif., expressed concern about the variability of the energy delivery.

"I've seen profound scarring with this device," he said. "I prefer a laser where I know exactly how much heat is going to be built up between each pass."

Dr. Zachary agreed that "there is no free lunch" with the Portrait Plasma. Double passes at 3.5–4 J could definitely produce scarring, although the device also has the potential for significant improvement in the skin, he said.

"Share [the potential of side effects] with the patient," he suggested. "Let them be part of the decision."

VariLite Laser

Dr. Bill H. Halmi, a Phoenix-based dermatologist, demonstrated the use of the VariLite dual wavelength (532 nm or 940 nm) laser, manufactured by Iridex, as a "spot welding device" that can target unsightly perinasal vessels by creating a dotted line of damage, leaving untreated millimeters of tissue between the spots.

"Go for little gaps" in the visible vessel line, Dr. Zachary said during the live video presentation.

As visual evidence of the vein disappeared under the beam of the laser, Dr. Zachary marveled, "Oh, that's very nice. It's better than sex!"

Dr. Zachary stressed the need for wearing protective goggles, preferably polarized for better visualization, when using the device.

Dr. Goldman offered a less rosy opinion. "This is the single most dangerous procedure to do. It puts holes in peoples' faces," he said.

Whitened skin evident in the video close-ups represents destruction of the epidermis. He also expressed concern that the laser has no epidermal cooling system to prevent permanent heat damage.

Beyond the safety concerns, Dr. Goldman questioned the permanence of the VariLite treatment. Red telangiectasias seen at the nasal alar area originate from the nasolabial artery and "will always come back," he pointed out. "[I would] never, ever tell a patient it's permanent, and I don't think it's better than sex."

DermaSweep

One of a wide variety of dermabrasion devices, DermaSweep (developed by CosMedic) requires no anesthesia and is becoming a popular modality among physicians, said Dr. Zachary.

This particular unit uses suction to draw the skin close to a variety of different bristles that range from "a silky, superficial … polisher to aggressive bristles," he said.

The device is said to enhance penetration of infusions of hyaluronic acid, vitamin C preparations, and Levulan (DUSA Pharmaceuticals Inc.).

"There is no way an infusion of hyaluronic acid is going to do a darned thing beyond 1–2 days," said Dr. Goldman. He also questioned its use in patients with a propensity to develop telangiectasias, such as those with rosacea.

Physicians should understand that if they use it prior to a light peel, the peel will become a deep peel with all of the associated side effects.

This said, Dr. Goldman acknowledged that the DermaSweep is an "outstanding machine" and that he uses it in his spa and on patients receiving photodynamic therapy.

All of the panelists commented on the immediate smoothing created by the low-impact device.

"It feels good for a day," said Dr. Margaret Mann, who is with the department of dermatology at the University of California, Irvine. "You get what you pay for."

She said, however, that she also uses the device to enhance penetration of aminolevulinic acid before photodynamic therapy, and she sees it as a nice introductory procedure. "It's great for the patient who comes in and just wants to know what an aesthetic procedure is like," Dr. Mann said.

Once such a patient feels comfortable, he or she "might move on to something more aggressive," she suggested.

Dr. Zachary disclosed that he has received equipment loans from Rhytec, Iridex, and CosMedic.

Dr. Goldman, Dr. Mann, and Dr. Halmi had no disclosures relating to the products mentioned in this article.

Skin Disease Education Foundation and this news organization are wholly owned subsidiaries of Elsevier.

HONOLULU — For community-acquired methicillin-resistant Staphylococcus aureus infections of the face, cephalexin should rarely be the antibiotic of choice, according to a decision analysis presented by researchers at the University of California, San Francisco, and at the annual meeting of the Pediatric Academic Societies.

And a second study, from Cardinal Glennon Children's Medical Center in St. Louis, questioned whether an antibiotic is needed at all to treat a primary skin infection if abscesses are incised and drained.

In the San Francisco study, Dr. Adam Hersh and associates weighed the trade-offs associated with three antibiotic choices—cephalexin, trimethoprim/sulfamethoxazole, or clindamycin—for empiric treatment of a purulent skin infection in a child younger than 18.

Cephalexin does not treat CA-MRSA; trimethoprim/sulfamethoxazole does not treat group A Streptococcus; and although clindamycin treats both, CA-MRSA is becoming increasingly resistant to it in some communities, said Dr. Hersh.

When community physicians consistently culture skin infections and prevalence and resistance rates can be developed, a decision tree analysis can be a method of “exquisitely weighing of the tradeoffs between treatment choices,” he said.

In communities that have a prevalence of CA-MRSA of greater than 10%, cephalexin is least likely to be effective, although it is the most widely prescribed antibiotic for this indication, the researchers noted.

Choosing between trimethoprim/sulfamethoxazole and clindamycin remains a delicate decision, depending on CA-MRSA resistance and prevalence of group A strep in an individual community.

In San Francisco, the overall prevalence of S. aureus in cultures of purulent pediatric skin infections is 90% (80% caused by CA-MRSA; 20% by methicillin-sensitive S. aureus). Of the remaining 10%, cultures show group A strep more than 99% of the time, said Dr. Hersh in an oral, late-breaking presentation.

Using these figures for a “base case” analysis, he concluded that probability rates for each drug having activity against an empiric skin infection were 95% for clindamycin, 89% for trimethoprim/sulfamethoxazole, and 28% for cephalexin.

Higher group A strep prevalence or high-rate clindamycin resistance in a community would tilt the decision tree model to trimethoprim/sulfamethoxazole or cephalexin, but it would be the rare community in which CA-MRSA prevalence was so low it would favor cephalexin for skin infections or other CA-MRSA affected conditions such as osteomyelitis or septic arthritis, said Dr. Hersh.

Dr. Myto Duong and associates in St. Louis selected tri-methoprim/sulfamethoxazole for a randomized, controlled, double-blind trial comparing antibiotic treatment of skin and soft tissue infections with treatment with incision and drainage in 161 immunocompetent children who presented to the emergency department at Cardinal Glennon Children's Medical Center. About half of the subjects were less than 5 years old.

Wound cultures showed CA-MRSA in 129 children (80%)—with 18% also clindamycin resistant—and methicillin-sensitive S. aureus in 14 (9%). Other bacteria were responsible for infections in remaining cases, including group A strep in 1%. Twelve patients were lost to follow-up.

In patients with complete data, there was complete resolution of lesions in 95% receiving a placebo after incision and drainage; and 96% of those receiving incision, drainage, and a 10-day antibiotic prescription before discharge. Compliance (taking at least half of the medication prescribed), was poor, at 66%.

Development of a new purulent skin lesion after treatment was equally likely in compliant patients on antibiotic or placebo. In the noncompliant subset, receipt of an antibiotic cut the risk of developing a new purulent skin lesion. In this group, 23% of those on placebo developed a new lesion versus 4% who received an antibiotic prescription.

Dr. Duong and Dr. Hersh disclosed no financial conflicts.

HONOLULU — For community-acquired methicillin-resistant Staphylococcus aureus infections of the face, cephalexin should rarely be the antibiotic of choice, according to a decision analysis presented by researchers at the University of California, San Francisco, and at the annual meeting of the Pediatric Academic Societies.

And a second study, from Cardinal Glennon Children's Medical Center in St. Louis, questioned whether an antibiotic is needed at all to treat a primary skin infection if abscesses are incised and drained.

In the San Francisco study, Dr. Adam Hersh and associates weighed the trade-offs associated with three antibiotic choices—cephalexin, trimethoprim/sulfamethoxazole, or clindamycin—for empiric treatment of a purulent skin infection in a child younger than 18.

Cephalexin does not treat CA-MRSA; trimethoprim/sulfamethoxazole does not treat group A Streptococcus; and although clindamycin treats both, CA-MRSA is becoming increasingly resistant to it in some communities, said Dr. Hersh.

When community physicians consistently culture skin infections and prevalence and resistance rates can be developed, a decision tree analysis can be a method of “exquisitely weighing of the tradeoffs between treatment choices,” he said.

In communities that have a prevalence of CA-MRSA of greater than 10%, cephalexin is least likely to be effective, although it is the most widely prescribed antibiotic for this indication, the researchers noted.

Choosing between trimethoprim/sulfamethoxazole and clindamycin remains a delicate decision, depending on CA-MRSA resistance and prevalence of group A strep in an individual community.

In San Francisco, the overall prevalence of S. aureus in cultures of purulent pediatric skin infections is 90% (80% caused by CA-MRSA; 20% by methicillin-sensitive S. aureus). Of the remaining 10%, cultures show group A strep more than 99% of the time, said Dr. Hersh in an oral, late-breaking presentation.

Using these figures for a “base case” analysis, he concluded that probability rates for each drug having activity against an empiric skin infection were 95% for clindamycin, 89% for trimethoprim/sulfamethoxazole, and 28% for cephalexin.

Higher group A strep prevalence or high-rate clindamycin resistance in a community would tilt the decision tree model to trimethoprim/sulfamethoxazole or cephalexin, but it would be the rare community in which CA-MRSA prevalence was so low it would favor cephalexin for skin infections or other CA-MRSA affected conditions such as osteomyelitis or septic arthritis, said Dr. Hersh.

Dr. Myto Duong and associates in St. Louis selected tri-methoprim/sulfamethoxazole for a randomized, controlled, double-blind trial comparing antibiotic treatment of skin and soft tissue infections with treatment with incision and drainage in 161 immunocompetent children who presented to the emergency department at Cardinal Glennon Children's Medical Center. About half of the subjects were less than 5 years old.

Wound cultures showed CA-MRSA in 129 children (80%)—with 18% also clindamycin resistant—and methicillin-sensitive S. aureus in 14 (9%). Other bacteria were responsible for infections in remaining cases, including group A strep in 1%. Twelve patients were lost to follow-up.

In patients with complete data, there was complete resolution of lesions in 95% receiving a placebo after incision and drainage; and 96% of those receiving incision, drainage, and a 10-day antibiotic prescription before discharge. Compliance (taking at least half of the medication prescribed), was poor, at 66%.

Development of a new purulent skin lesion after treatment was equally likely in compliant patients on antibiotic or placebo. In the noncompliant subset, receipt of an antibiotic cut the risk of developing a new purulent skin lesion. In this group, 23% of those on placebo developed a new lesion versus 4% who received an antibiotic prescription.

Dr. Duong and Dr. Hersh disclosed no financial conflicts.

HONOLULU — For community-acquired methicillin-resistant Staphylococcus aureus infections of the face, cephalexin should rarely be the antibiotic of choice, according to a decision analysis presented by researchers at the University of California, San Francisco, and at the annual meeting of the Pediatric Academic Societies.

And a second study, from Cardinal Glennon Children's Medical Center in St. Louis, questioned whether an antibiotic is needed at all to treat a primary skin infection if abscesses are incised and drained.

In the San Francisco study, Dr. Adam Hersh and associates weighed the trade-offs associated with three antibiotic choices—cephalexin, trimethoprim/sulfamethoxazole, or clindamycin—for empiric treatment of a purulent skin infection in a child younger than 18.

Cephalexin does not treat CA-MRSA; trimethoprim/sulfamethoxazole does not treat group A Streptococcus; and although clindamycin treats both, CA-MRSA is becoming increasingly resistant to it in some communities, said Dr. Hersh.

When community physicians consistently culture skin infections and prevalence and resistance rates can be developed, a decision tree analysis can be a method of “exquisitely weighing of the tradeoffs between treatment choices,” he said.

In communities that have a prevalence of CA-MRSA of greater than 10%, cephalexin is least likely to be effective, although it is the most widely prescribed antibiotic for this indication, the researchers noted.

Choosing between trimethoprim/sulfamethoxazole and clindamycin remains a delicate decision, depending on CA-MRSA resistance and prevalence of group A strep in an individual community.

In San Francisco, the overall prevalence of S. aureus in cultures of purulent pediatric skin infections is 90% (80% caused by CA-MRSA; 20% by methicillin-sensitive S. aureus). Of the remaining 10%, cultures show group A strep more than 99% of the time, said Dr. Hersh in an oral, late-breaking presentation.

Using these figures for a “base case” analysis, he concluded that probability rates for each drug having activity against an empiric skin infection were 95% for clindamycin, 89% for trimethoprim/sulfamethoxazole, and 28% for cephalexin.

Higher group A strep prevalence or high-rate clindamycin resistance in a community would tilt the decision tree model to trimethoprim/sulfamethoxazole or cephalexin, but it would be the rare community in which CA-MRSA prevalence was so low it would favor cephalexin for skin infections or other CA-MRSA affected conditions such as osteomyelitis or septic arthritis, said Dr. Hersh.

Dr. Myto Duong and associates in St. Louis selected tri-methoprim/sulfamethoxazole for a randomized, controlled, double-blind trial comparing antibiotic treatment of skin and soft tissue infections with treatment with incision and drainage in 161 immunocompetent children who presented to the emergency department at Cardinal Glennon Children's Medical Center. About half of the subjects were less than 5 years old.

Wound cultures showed CA-MRSA in 129 children (80%)—with 18% also clindamycin resistant—and methicillin-sensitive S. aureus in 14 (9%). Other bacteria were responsible for infections in remaining cases, including group A strep in 1%. Twelve patients were lost to follow-up.

In patients with complete data, there was complete resolution of lesions in 95% receiving a placebo after incision and drainage; and 96% of those receiving incision, drainage, and a 10-day antibiotic prescription before discharge. Compliance (taking at least half of the medication prescribed), was poor, at 66%.

Development of a new purulent skin lesion after treatment was equally likely in compliant patients on antibiotic or placebo. In the noncompliant subset, receipt of an antibiotic cut the risk of developing a new purulent skin lesion. In this group, 23% of those on placebo developed a new lesion versus 4% who received an antibiotic prescription.

Dr. Duong and Dr. Hersh disclosed no financial conflicts.

HONOLULU — A complex regimen of 21 vaccines added to the routine child immunization schedule since 2000 has left many health care providers shaking their heads.

Dr. Andrew D. Racine took his frustration one step further, and took out his calculator.

By his calculations, administration of the new vaccines recommended for pediatric patients from infancy through adolescence by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians has added up to 17.8 weeks of salary for a full-time nurse in a busy practice, as well an up-front inventory cost of $100,000-$200,000.

“The instigation for this [study] was just looking at our nursing staff,” said Dr. Racine following the oral presentation of his results at the annual meeting of the Pediatric Academic Societies.

“They were going crazy.”

Dr. Racine, chief of clinical pediatrics at Albert Einstein College of Medicine, New York, noted that 10 childhood vaccines were recommended in 1983. That number now stands at a mean 27 vaccines per healthy child, depending on their gender and risk profiles.

Added to the schedule since 2000 are pneumococcal 7-valent conjugate vaccine (PCV7) at 2, 4, 6, and 12 months; influenza vaccine at 6 and 7 months, then annually to all patients up to 5 years and to 50% of 6- to 21-year-olds; meningococcal polysaccharide conjugate (MCV4) vaccine and tetanus/diphtheria toxoid/acellular pertussis (Tdap) vaccine at 11 years; hepatitis A vaccine at 18 and 24 months; rotavirus vaccine at 2, 4, and 6 months; 3 human papillomavirus (HPV) vaccines to girls at 11 years; and a second varicella vaccine at 5 years.

To find out how much staff time was needed to administer these added inoculations, Dr. Racine conducted an observational time-flow analysis of nurses in a busy urban academic practice as they simulated the tasks required to deliver one childhood inoculation.

He then multiplied the mean time to deliver a shot by the number of vaccines required per one pediatric patient over the course of childhood and calculated the total time cost to practices of various sizes.

The study was designed to be widely applicable to many types of practices: large or small, private or academic, staffed by experienced or relatively inexperienced nurses.

Tasks in the simulation included checking the chart for a vaccine order, obtaining the vaccine from storage and drawing up the medication, accessing the examination room, counseling parents, administering the shot and, finally, recording the immunization on the child's personal immunization card and on the chart.

The analysis used conservative assumptions, Dr. Racine noted.

Even so, the time added up to a substantial burden, even for a small panel of 1,000 patients, he reported.

“We've got anywhere from about 4.5 weeks of nursing time for a small panel that gave shots quickly to almost 18 weeks for a full-time equivalent nurse just to give these vaccines to a large panel of patients,” said Dr. Racine. (See box.)

The potential implications of the study are profound, he added.

“We think this incremental cost [in terms of nursing time and up-front outlays for vaccine stock] presents significant challenges for the pediatric community and to the public policy goal articulated in Healthy People 2010 of increasing the proportion of all children and adolescents who receive all of their recommended vaccines,” he said.

ELSEVIER GLOBAL MEDICAL NEWS

HONOLULU — A complex regimen of 21 vaccines added to the routine child immunization schedule since 2000 has left many health care providers shaking their heads.

Dr. Andrew D. Racine took his frustration one step further, and took out his calculator.

By his calculations, administration of the new vaccines recommended for pediatric patients from infancy through adolescence by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians has added up to 17.8 weeks of salary for a full-time nurse in a busy practice, as well an up-front inventory cost of $100,000-$200,000.

“The instigation for this [study] was just looking at our nursing staff,” said Dr. Racine following the oral presentation of his results at the annual meeting of the Pediatric Academic Societies.

“They were going crazy.”

Dr. Racine, chief of clinical pediatrics at Albert Einstein College of Medicine, New York, noted that 10 childhood vaccines were recommended in 1983. That number now stands at a mean 27 vaccines per healthy child, depending on their gender and risk profiles.

Added to the schedule since 2000 are pneumococcal 7-valent conjugate vaccine (PCV7) at 2, 4, 6, and 12 months; influenza vaccine at 6 and 7 months, then annually to all patients up to 5 years and to 50% of 6- to 21-year-olds; meningococcal polysaccharide conjugate (MCV4) vaccine and tetanus/diphtheria toxoid/acellular pertussis (Tdap) vaccine at 11 years; hepatitis A vaccine at 18 and 24 months; rotavirus vaccine at 2, 4, and 6 months; 3 human papillomavirus (HPV) vaccines to girls at 11 years; and a second varicella vaccine at 5 years.

To find out how much staff time was needed to administer these added inoculations, Dr. Racine conducted an observational time-flow analysis of nurses in a busy urban academic practice as they simulated the tasks required to deliver one childhood inoculation.

He then multiplied the mean time to deliver a shot by the number of vaccines required per one pediatric patient over the course of childhood and calculated the total time cost to practices of various sizes.

The study was designed to be widely applicable to many types of practices: large or small, private or academic, staffed by experienced or relatively inexperienced nurses.

Tasks in the simulation included checking the chart for a vaccine order, obtaining the vaccine from storage and drawing up the medication, accessing the examination room, counseling parents, administering the shot and, finally, recording the immunization on the child's personal immunization card and on the chart.

The analysis used conservative assumptions, Dr. Racine noted.

Even so, the time added up to a substantial burden, even for a small panel of 1,000 patients, he reported.

“We've got anywhere from about 4.5 weeks of nursing time for a small panel that gave shots quickly to almost 18 weeks for a full-time equivalent nurse just to give these vaccines to a large panel of patients,” said Dr. Racine. (See box.)

The potential implications of the study are profound, he added.

“We think this incremental cost [in terms of nursing time and up-front outlays for vaccine stock] presents significant challenges for the pediatric community and to the public policy goal articulated in Healthy People 2010 of increasing the proportion of all children and adolescents who receive all of their recommended vaccines,” he said.

ELSEVIER GLOBAL MEDICAL NEWS

HONOLULU — A complex regimen of 21 vaccines added to the routine child immunization schedule since 2000 has left many health care providers shaking their heads.

Dr. Andrew D. Racine took his frustration one step further, and took out his calculator.

By his calculations, administration of the new vaccines recommended for pediatric patients from infancy through adolescence by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians has added up to 17.8 weeks of salary for a full-time nurse in a busy practice, as well an up-front inventory cost of $100,000-$200,000.

“The instigation for this [study] was just looking at our nursing staff,” said Dr. Racine following the oral presentation of his results at the annual meeting of the Pediatric Academic Societies.

“They were going crazy.”

Dr. Racine, chief of clinical pediatrics at Albert Einstein College of Medicine, New York, noted that 10 childhood vaccines were recommended in 1983. That number now stands at a mean 27 vaccines per healthy child, depending on their gender and risk profiles.

Added to the schedule since 2000 are pneumococcal 7-valent conjugate vaccine (PCV7) at 2, 4, 6, and 12 months; influenza vaccine at 6 and 7 months, then annually to all patients up to 5 years and to 50% of 6- to 21-year-olds; meningococcal polysaccharide conjugate (MCV4) vaccine and tetanus/diphtheria toxoid/acellular pertussis (Tdap) vaccine at 11 years; hepatitis A vaccine at 18 and 24 months; rotavirus vaccine at 2, 4, and 6 months; 3 human papillomavirus (HPV) vaccines to girls at 11 years; and a second varicella vaccine at 5 years.

To find out how much staff time was needed to administer these added inoculations, Dr. Racine conducted an observational time-flow analysis of nurses in a busy urban academic practice as they simulated the tasks required to deliver one childhood inoculation.

He then multiplied the mean time to deliver a shot by the number of vaccines required per one pediatric patient over the course of childhood and calculated the total time cost to practices of various sizes.

The study was designed to be widely applicable to many types of practices: large or small, private or academic, staffed by experienced or relatively inexperienced nurses.

Tasks in the simulation included checking the chart for a vaccine order, obtaining the vaccine from storage and drawing up the medication, accessing the examination room, counseling parents, administering the shot and, finally, recording the immunization on the child's personal immunization card and on the chart.

The analysis used conservative assumptions, Dr. Racine noted.

Even so, the time added up to a substantial burden, even for a small panel of 1,000 patients, he reported.

“We've got anywhere from about 4.5 weeks of nursing time for a small panel that gave shots quickly to almost 18 weeks for a full-time equivalent nurse just to give these vaccines to a large panel of patients,” said Dr. Racine. (See box.)

The potential implications of the study are profound, he added.

“We think this incremental cost [in terms of nursing time and up-front outlays for vaccine stock] presents significant challenges for the pediatric community and to the public policy goal articulated in Healthy People 2010 of increasing the proportion of all children and adolescents who receive all of their recommended vaccines,” he said.

ELSEVIER GLOBAL MEDICAL NEWS

HONOLULU — Insight into what's happening at home may help to explain behavior problems and school absenteeism in children with asthma, according to studies presented at the annual meeting of the Pediatric Academic Societies.

Researchers from the University of Rochester (N.Y.) studied sleep-disordered breathing in children with asthma in an attempt to find possible links to problem behavior issues that have previously been reported in this patient population.

The associations were powerful, with serious behavioral problems documented in twice as many asthmatic children with sleep problems as in those with asthma alone, reported Maria Fagnano, health project coordinator for the department of pediatrics at the university.

A second and unrelated study explored school absenteeism among children with asthma and found that parental chronic disease plays a role in how children's health is perceived and in how many school days they miss, regardless of asthma severity.

The New York study enrolled 194 inner-city children aged 4–10 years, with physician-diagnosed asthma, who attended a school-based asthma program.

Parents were administered a 28-item validated questionnaire on behavioral issues (the Behavior Problem Index or BPI) and a 22-item validated questionnaire on sleep patterns, the Sleep-Related Breathing Disorder Subscale.

Most of the children were male (56%); African American (66%) or Hispanic (26%); and on Medicaid (73%). Their average age was 8 years. Prior testing had revealed that almost one-third of their parents suffered from depression.

One-third of the children had sleep scores highly predictive of sleep-disordered breathing, which can range from snoring to sleep apnea, said Ms. Fagnano. Girls and children with high body mass indexes were at higher relative risk of elevated sleep-disordered breathing scores than were other children with asthma enrolled in the study.

Nearly the same percentage—32% of children—scored above a 14 on the Behavior Problem Index, a range considered to be indicative of behavior problems serious enough that they might warrant professional intervention.

Twice as many children with high sleep-disordered breathing scores—48%—earned elevated scores on the BPI than did those with normal sleep scores, 24%.

Among problem behavior subscales, independent correlations were found between children with elevated sleep-disordered breathing scores and internalizing behavior problems, externalizing behavior problems, anxious or depressed behavior, headstrong behavior—and, in a separate linear regression analysis, hyperactive behavior.

“A large proportion of urban children with asthma have sleep-disordered breathing, and poor sleep is independently associated with behavior problems,” said Ms. Fagnano. “Screening for sleep-disordered breathing among high-risk populations might help to identify children who could benefit from further interventions.”

The second study examined data from 561 parent/child dyads surveyed as part of the nationally representative 2003 National Health Interview Survey, Dr. Ellen A. Lipstein reported at the meeting.

All of the children, aged 5–17 years, had been diagnosed with asthma by a physician, and 39% of their parents reported being diagnosed with a chronic disease such as heart disease, emphysema or asthma, diabetes, or arthritis.

No difference was seen in inhaler use by children of parents with or without chronic disease.

When researchers controlled for other factors, including measures of childhood asthma severity, parents with chronic disease were three times less likely to judge their children's health as excellent or very good, and their children missed, on average, 1.3 more days of school during the previous year.

“These findings suggest that parental chronic disease may lead to increased perceptions of child medical vulnerability,” said Dr. Lipstein of the Harvard Medical School and the Massachusetts General Hospital center for child and adolescent health policy, both in Boston.

“Furthermore, the increased absenteeism suggests that parents with chronic disease not only perceive [greater] child vulnerability, but they act on these perceptions,” she said.

HONOLULU — Insight into what's happening at home may help to explain behavior problems and school absenteeism in children with asthma, according to studies presented at the annual meeting of the Pediatric Academic Societies.

Researchers from the University of Rochester (N.Y.) studied sleep-disordered breathing in children with asthma in an attempt to find possible links to problem behavior issues that have previously been reported in this patient population.

The associations were powerful, with serious behavioral problems documented in twice as many asthmatic children with sleep problems as in those with asthma alone, reported Maria Fagnano, health project coordinator for the department of pediatrics at the university.

A second and unrelated study explored school absenteeism among children with asthma and found that parental chronic disease plays a role in how children's health is perceived and in how many school days they miss, regardless of asthma severity.

The New York study enrolled 194 inner-city children aged 4–10 years, with physician-diagnosed asthma, who attended a school-based asthma program.

Parents were administered a 28-item validated questionnaire on behavioral issues (the Behavior Problem Index or BPI) and a 22-item validated questionnaire on sleep patterns, the Sleep-Related Breathing Disorder Subscale.

Most of the children were male (56%); African American (66%) or Hispanic (26%); and on Medicaid (73%). Their average age was 8 years. Prior testing had revealed that almost one-third of their parents suffered from depression.

One-third of the children had sleep scores highly predictive of sleep-disordered breathing, which can range from snoring to sleep apnea, said Ms. Fagnano. Girls and children with high body mass indexes were at higher relative risk of elevated sleep-disordered breathing scores than were other children with asthma enrolled in the study.

Nearly the same percentage—32% of children—scored above a 14 on the Behavior Problem Index, a range considered to be indicative of behavior problems serious enough that they might warrant professional intervention.

Twice as many children with high sleep-disordered breathing scores—48%—earned elevated scores on the BPI than did those with normal sleep scores, 24%.

Among problem behavior subscales, independent correlations were found between children with elevated sleep-disordered breathing scores and internalizing behavior problems, externalizing behavior problems, anxious or depressed behavior, headstrong behavior—and, in a separate linear regression analysis, hyperactive behavior.

“A large proportion of urban children with asthma have sleep-disordered breathing, and poor sleep is independently associated with behavior problems,” said Ms. Fagnano. “Screening for sleep-disordered breathing among high-risk populations might help to identify children who could benefit from further interventions.”

The second study examined data from 561 parent/child dyads surveyed as part of the nationally representative 2003 National Health Interview Survey, Dr. Ellen A. Lipstein reported at the meeting.

All of the children, aged 5–17 years, had been diagnosed with asthma by a physician, and 39% of their parents reported being diagnosed with a chronic disease such as heart disease, emphysema or asthma, diabetes, or arthritis.

No difference was seen in inhaler use by children of parents with or without chronic disease.

When researchers controlled for other factors, including measures of childhood asthma severity, parents with chronic disease were three times less likely to judge their children's health as excellent or very good, and their children missed, on average, 1.3 more days of school during the previous year.

“These findings suggest that parental chronic disease may lead to increased perceptions of child medical vulnerability,” said Dr. Lipstein of the Harvard Medical School and the Massachusetts General Hospital center for child and adolescent health policy, both in Boston.

“Furthermore, the increased absenteeism suggests that parents with chronic disease not only perceive [greater] child vulnerability, but they act on these perceptions,” she said.

HONOLULU — Insight into what's happening at home may help to explain behavior problems and school absenteeism in children with asthma, according to studies presented at the annual meeting of the Pediatric Academic Societies.

Researchers from the University of Rochester (N.Y.) studied sleep-disordered breathing in children with asthma in an attempt to find possible links to problem behavior issues that have previously been reported in this patient population.

The associations were powerful, with serious behavioral problems documented in twice as many asthmatic children with sleep problems as in those with asthma alone, reported Maria Fagnano, health project coordinator for the department of pediatrics at the university.

A second and unrelated study explored school absenteeism among children with asthma and found that parental chronic disease plays a role in how children's health is perceived and in how many school days they miss, regardless of asthma severity.

The New York study enrolled 194 inner-city children aged 4–10 years, with physician-diagnosed asthma, who attended a school-based asthma program.

Parents were administered a 28-item validated questionnaire on behavioral issues (the Behavior Problem Index or BPI) and a 22-item validated questionnaire on sleep patterns, the Sleep-Related Breathing Disorder Subscale.

Most of the children were male (56%); African American (66%) or Hispanic (26%); and on Medicaid (73%). Their average age was 8 years. Prior testing had revealed that almost one-third of their parents suffered from depression.

One-third of the children had sleep scores highly predictive of sleep-disordered breathing, which can range from snoring to sleep apnea, said Ms. Fagnano. Girls and children with high body mass indexes were at higher relative risk of elevated sleep-disordered breathing scores than were other children with asthma enrolled in the study.

Nearly the same percentage—32% of children—scored above a 14 on the Behavior Problem Index, a range considered to be indicative of behavior problems serious enough that they might warrant professional intervention.

Twice as many children with high sleep-disordered breathing scores—48%—earned elevated scores on the BPI than did those with normal sleep scores, 24%.

Among problem behavior subscales, independent correlations were found between children with elevated sleep-disordered breathing scores and internalizing behavior problems, externalizing behavior problems, anxious or depressed behavior, headstrong behavior—and, in a separate linear regression analysis, hyperactive behavior.

“A large proportion of urban children with asthma have sleep-disordered breathing, and poor sleep is independently associated with behavior problems,” said Ms. Fagnano. “Screening for sleep-disordered breathing among high-risk populations might help to identify children who could benefit from further interventions.”

The second study examined data from 561 parent/child dyads surveyed as part of the nationally representative 2003 National Health Interview Survey, Dr. Ellen A. Lipstein reported at the meeting.

All of the children, aged 5–17 years, had been diagnosed with asthma by a physician, and 39% of their parents reported being diagnosed with a chronic disease such as heart disease, emphysema or asthma, diabetes, or arthritis.

No difference was seen in inhaler use by children of parents with or without chronic disease.

When researchers controlled for other factors, including measures of childhood asthma severity, parents with chronic disease were three times less likely to judge their children's health as excellent or very good, and their children missed, on average, 1.3 more days of school during the previous year.

“These findings suggest that parental chronic disease may lead to increased perceptions of child medical vulnerability,” said Dr. Lipstein of the Harvard Medical School and the Massachusetts General Hospital center for child and adolescent health policy, both in Boston.

“Furthermore, the increased absenteeism suggests that parents with chronic disease not only perceive [greater] child vulnerability, but they act on these perceptions,” she said.

HONOLULU — Corporal punishment was being used by 1 in 7 mothers to discipline their 11-month-olds in a prospective study of 1,378 mothers.

Dr. Esther K. Chung, primary investigator, said the findings suggest that physicians may want to consider addressing the issues of spanking and corporal punishment during routine infant visits, rather than waiting until the toddler years.

Women participating in the Philadelphia-based study were initially interviewed during their first prenatal visit concerning their attitudes about corporal punishment and their own childhood experiences. Follow-up interviews were conducted in their homes at 3 and 11 months post partum, Dr. Chung said at the annual meeting of the Pediatric Academic Societies.

A total of 1,378 mothers were enrolled, and almost half of them were first-time mothers. Of the cohort, 75% were African American and 76% were single; their average mean income was $8,271 a year.

More than half of the mothers described suffering physical abuse before the age of 16, and 13% reported being sexually abused during childhood; 14% had experienced domestic violence. Almost 20% had witnessed a shooting during childhood, and 46% knew the victim of a shooting.

The women's lives were not devoid of affection, however.

Half of them reported that, during childhood, they had often been told they were great. Nearly 60% of them said they had received hugs when they did something well. A positive maternal relationship was reported by 76%, and 53% said they had experienced a positive relationship with their fathers.

During the prenatal visit, 19% supported corporal punishment in their responses to statements such as, “Spanking children when they misbehave teaches them to behave,” and “Children who bite others need to be bitten so they can learn what it feels like.”

By the time an interview was conducted 11 months post partum, 14% of the mothers were already using corporal punishment on their babies, reported Dr. Chung, a pediatrician at Jefferson Medical College and the Alfred I. duPont Hospital in Philadelphia.

The use of corporal punishment post partum was strongly correlated with a mother's own history of physical abuse during childhood, her experience of verbal hostility during her own childhood, and her own favorable attitude in the prenatal period toward the use of corporal punishment.

Expressing a positive attitude toward corporal punishment during pregnancy increased the odds of applying corporal punishment almost twofold by 11 months post partum. Physicians should consider the findings when they counsel mothers-to-be and mothers of young babies. Although some parents “look at us like we're crazy,” the message that there are alternatives to corporal punishment is heard, said Dr. Chung. “I don't think our efforts at educating families fall on deaf ears.”

HONOLULU — Corporal punishment was being used by 1 in 7 mothers to discipline their 11-month-olds in a prospective study of 1,378 mothers.

Dr. Esther K. Chung, primary investigator, said the findings suggest that physicians may want to consider addressing the issues of spanking and corporal punishment during routine infant visits, rather than waiting until the toddler years.

Women participating in the Philadelphia-based study were initially interviewed during their first prenatal visit concerning their attitudes about corporal punishment and their own childhood experiences. Follow-up interviews were conducted in their homes at 3 and 11 months post partum, Dr. Chung said at the annual meeting of the Pediatric Academic Societies.

A total of 1,378 mothers were enrolled, and almost half of them were first-time mothers. Of the cohort, 75% were African American and 76% were single; their average mean income was $8,271 a year.

More than half of the mothers described suffering physical abuse before the age of 16, and 13% reported being sexually abused during childhood; 14% had experienced domestic violence. Almost 20% had witnessed a shooting during childhood, and 46% knew the victim of a shooting.

The women's lives were not devoid of affection, however.

Half of them reported that, during childhood, they had often been told they were great. Nearly 60% of them said they had received hugs when they did something well. A positive maternal relationship was reported by 76%, and 53% said they had experienced a positive relationship with their fathers.

During the prenatal visit, 19% supported corporal punishment in their responses to statements such as, “Spanking children when they misbehave teaches them to behave,” and “Children who bite others need to be bitten so they can learn what it feels like.”

By the time an interview was conducted 11 months post partum, 14% of the mothers were already using corporal punishment on their babies, reported Dr. Chung, a pediatrician at Jefferson Medical College and the Alfred I. duPont Hospital in Philadelphia.

The use of corporal punishment post partum was strongly correlated with a mother's own history of physical abuse during childhood, her experience of verbal hostility during her own childhood, and her own favorable attitude in the prenatal period toward the use of corporal punishment.

Expressing a positive attitude toward corporal punishment during pregnancy increased the odds of applying corporal punishment almost twofold by 11 months post partum. Physicians should consider the findings when they counsel mothers-to-be and mothers of young babies. Although some parents “look at us like we're crazy,” the message that there are alternatives to corporal punishment is heard, said Dr. Chung. “I don't think our efforts at educating families fall on deaf ears.”

HONOLULU — Corporal punishment was being used by 1 in 7 mothers to discipline their 11-month-olds in a prospective study of 1,378 mothers.

Dr. Esther K. Chung, primary investigator, said the findings suggest that physicians may want to consider addressing the issues of spanking and corporal punishment during routine infant visits, rather than waiting until the toddler years.

Women participating in the Philadelphia-based study were initially interviewed during their first prenatal visit concerning their attitudes about corporal punishment and their own childhood experiences. Follow-up interviews were conducted in their homes at 3 and 11 months post partum, Dr. Chung said at the annual meeting of the Pediatric Academic Societies.

A total of 1,378 mothers were enrolled, and almost half of them were first-time mothers. Of the cohort, 75% were African American and 76% were single; their average mean income was $8,271 a year.

More than half of the mothers described suffering physical abuse before the age of 16, and 13% reported being sexually abused during childhood; 14% had experienced domestic violence. Almost 20% had witnessed a shooting during childhood, and 46% knew the victim of a shooting.

The women's lives were not devoid of affection, however.

Half of them reported that, during childhood, they had often been told they were great. Nearly 60% of them said they had received hugs when they did something well. A positive maternal relationship was reported by 76%, and 53% said they had experienced a positive relationship with their fathers.

During the prenatal visit, 19% supported corporal punishment in their responses to statements such as, “Spanking children when they misbehave teaches them to behave,” and “Children who bite others need to be bitten so they can learn what it feels like.”

By the time an interview was conducted 11 months post partum, 14% of the mothers were already using corporal punishment on their babies, reported Dr. Chung, a pediatrician at Jefferson Medical College and the Alfred I. duPont Hospital in Philadelphia.

The use of corporal punishment post partum was strongly correlated with a mother's own history of physical abuse during childhood, her experience of verbal hostility during her own childhood, and her own favorable attitude in the prenatal period toward the use of corporal punishment.

Expressing a positive attitude toward corporal punishment during pregnancy increased the odds of applying corporal punishment almost twofold by 11 months post partum. Physicians should consider the findings when they counsel mothers-to-be and mothers of young babies. Although some parents “look at us like we're crazy,” the message that there are alternatives to corporal punishment is heard, said Dr. Chung. “I don't think our efforts at educating families fall on deaf ears.”