USP Asks Physicians' Help in Heading Off Medication Errors

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Soaring numbers of drugs with similar names have prompted the U.S. Pharmacopeia to ask providers to include an “indication for use” on prescriptions.

The recommendation is in U.S. Pharmacopeia's eighth annual MEDMARX report, which is based on a review of more than 26,000 records submitted to the MEDMARX database from 2003 to 2006.

The records implicate nearly 1,500 drugs in medication errors due to brand or generic names that could be confused. From these data, U.S. Pharmacopeia (USP) compiled a list of more than 3,000 drug pairs that look or sound alike, nearly double the number of pairs identified in USP's 2004 report, said Diane Cousins, R.Ph.

USP also operates, in conjunction with the Institute for Safe Medication Practices, the Medication Errors Reporting Program (MER), which allows health care professioals to report confidentially potential and actual medication errors directly to USP.

USP reviewed both MEDMARX and MER to summarize the variables associated with more than 26,000 look-alike and/or sound-alike (LASA) errors, of which 1.4% (384) resulted in harm or death. More than 670 health care facilities contributed 26,000 records, according to the report.

“We looked at lists of the top 200 drugs prescribed and used in hospitals, and virtually every time, all of the top 10 appeared within the USP similar names list,” said Ms. Cousins, USP's vice president of health care quality and information.

“Although pharmacy personnel, who are generally technicians, made the majority of errors, pharmacists as a group identified, prevented, and reported more than any other staff,” she said.

The report also identifies an emerging trend of look-alike drug names in computerized direct order entry systems. She added the LASA-related error problem is further compounded by the indiscriminate use of suffixes, as well as look-alike packaging and labeling.

Over the 3-year period, the drug most commonly confused with others was Cefazolin, a first-generation cephalosporin antibiotic. “We found it to be confused with 15 other drugs, primarily antimicrobials, which might be explained by the fact that this is the most frequently used class of medications,” said Ms. Cousins.

Drug mix-ups led to seven reported fatalities, including two due to confusion over the Alzheimer's drug Reminyl (galantamine) and the antidiabetes drug Amaryl (glimepiride).

In 2005, recognizing the high risk of confusion and subsequent fatal hypoglycemia, Ortho-McNeil Neurologics Inc. announced that the name Reminyl had been changed to Razadyne to avoid confusion with Amaryl. In another case, a physician was preparing to intubate a patient and calculated the dose for rocuronium (Zemuron), a preintubation agent used to assist with the procedure. The physician gave orders for the nurse to obtain the medication and indicated the volume to administer to the patient. The nurse obtained and administered the neuromuscular blocking agent vecuronium (Norcuron) instead, leading to a fatal heart arrhythmia.

Other deaths involved mix-ups between the anticonvulsant primidone and prednisone; the antiepileptic drug phenytoin sodium and the barbiturate phenobarbital; and Norcuron and the heart failure treatment Natrecor (nesiritide recombinant).

Errors occur with over-the-counter medications, too. Ms. Cousins described the aural confusion when an order for Ferro-Sequel 500 mg—an iron replacement—was transcribed as Serrosequel 500 mg and the order was misread as Seroquel 500 mg—an antipsychotic.

The rate of mix-ups involving brand name versus generic drugs was about evenly split, 57% and 43%, respectively, Ms. Cousins said, adding that while most errors were made in pharmacies, many are due to confusion over the prescribing physician's handwriting.

“Errors also are due to physicians using short codes for medications, such as 'clon,' for clonazepam or clonapine,” she said, adding that electronically written prescriptions using a computer or label machine would eliminate many errors.

It would also be helpful if the FDA were given more authority to force name changes during the drug review process.

The recommendation that physicians include indications for use in their prescriptions is not an attempt to impose on privacy, Ms. Cousins said. “All that is needed are simple inclusions, such as 'for sinus,' 'for heart,' or, 'for cough,'” she said. This also would help patients avoid confusion.

USP also recommends that “tall man lettering” be implemented in pharmacy software, labeling, and order writing to say, for example, “acetaZOLamide” (glaucoma) and “acetoHEXamide” (diabetes).

Where risk exists, USP recommends:

▸ Consider the potential for mix-ups before adding a drug to your formulary.

▸ Physically separate or differentiate products with similar names while they are being stored on the shelf.

▸ Disseminate information about products that have been confused at your facility, to build awareness among staff.

▸ Prohibit verbal orders for sound-alikes that have been mixed up at your facility.

 

 

“Physicians' offices should always require a read-back from pharmacists, making sure that they both say and spell the drug name,” Ms. Cousins said.

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Soaring numbers of drugs with similar names have prompted the U.S. Pharmacopeia to ask providers to include an “indication for use” on prescriptions.

The recommendation is in U.S. Pharmacopeia's eighth annual MEDMARX report, which is based on a review of more than 26,000 records submitted to the MEDMARX database from 2003 to 2006.

The records implicate nearly 1,500 drugs in medication errors due to brand or generic names that could be confused. From these data, U.S. Pharmacopeia (USP) compiled a list of more than 3,000 drug pairs that look or sound alike, nearly double the number of pairs identified in USP's 2004 report, said Diane Cousins, R.Ph.

USP also operates, in conjunction with the Institute for Safe Medication Practices, the Medication Errors Reporting Program (MER), which allows health care professioals to report confidentially potential and actual medication errors directly to USP.

USP reviewed both MEDMARX and MER to summarize the variables associated with more than 26,000 look-alike and/or sound-alike (LASA) errors, of which 1.4% (384) resulted in harm or death. More than 670 health care facilities contributed 26,000 records, according to the report.

“We looked at lists of the top 200 drugs prescribed and used in hospitals, and virtually every time, all of the top 10 appeared within the USP similar names list,” said Ms. Cousins, USP's vice president of health care quality and information.

“Although pharmacy personnel, who are generally technicians, made the majority of errors, pharmacists as a group identified, prevented, and reported more than any other staff,” she said.

The report also identifies an emerging trend of look-alike drug names in computerized direct order entry systems. She added the LASA-related error problem is further compounded by the indiscriminate use of suffixes, as well as look-alike packaging and labeling.

Over the 3-year period, the drug most commonly confused with others was Cefazolin, a first-generation cephalosporin antibiotic. “We found it to be confused with 15 other drugs, primarily antimicrobials, which might be explained by the fact that this is the most frequently used class of medications,” said Ms. Cousins.

Drug mix-ups led to seven reported fatalities, including two due to confusion over the Alzheimer's drug Reminyl (galantamine) and the antidiabetes drug Amaryl (glimepiride).

In 2005, recognizing the high risk of confusion and subsequent fatal hypoglycemia, Ortho-McNeil Neurologics Inc. announced that the name Reminyl had been changed to Razadyne to avoid confusion with Amaryl. In another case, a physician was preparing to intubate a patient and calculated the dose for rocuronium (Zemuron), a preintubation agent used to assist with the procedure. The physician gave orders for the nurse to obtain the medication and indicated the volume to administer to the patient. The nurse obtained and administered the neuromuscular blocking agent vecuronium (Norcuron) instead, leading to a fatal heart arrhythmia.

Other deaths involved mix-ups between the anticonvulsant primidone and prednisone; the antiepileptic drug phenytoin sodium and the barbiturate phenobarbital; and Norcuron and the heart failure treatment Natrecor (nesiritide recombinant).

Errors occur with over-the-counter medications, too. Ms. Cousins described the aural confusion when an order for Ferro-Sequel 500 mg—an iron replacement—was transcribed as Serrosequel 500 mg and the order was misread as Seroquel 500 mg—an antipsychotic.

The rate of mix-ups involving brand name versus generic drugs was about evenly split, 57% and 43%, respectively, Ms. Cousins said, adding that while most errors were made in pharmacies, many are due to confusion over the prescribing physician's handwriting.

“Errors also are due to physicians using short codes for medications, such as 'clon,' for clonazepam or clonapine,” she said, adding that electronically written prescriptions using a computer or label machine would eliminate many errors.

It would also be helpful if the FDA were given more authority to force name changes during the drug review process.

The recommendation that physicians include indications for use in their prescriptions is not an attempt to impose on privacy, Ms. Cousins said. “All that is needed are simple inclusions, such as 'for sinus,' 'for heart,' or, 'for cough,'” she said. This also would help patients avoid confusion.

USP also recommends that “tall man lettering” be implemented in pharmacy software, labeling, and order writing to say, for example, “acetaZOLamide” (glaucoma) and “acetoHEXamide” (diabetes).

Where risk exists, USP recommends:

▸ Consider the potential for mix-ups before adding a drug to your formulary.

▸ Physically separate or differentiate products with similar names while they are being stored on the shelf.

▸ Disseminate information about products that have been confused at your facility, to build awareness among staff.

▸ Prohibit verbal orders for sound-alikes that have been mixed up at your facility.

 

 

“Physicians' offices should always require a read-back from pharmacists, making sure that they both say and spell the drug name,” Ms. Cousins said.

Soaring numbers of drugs with similar names have prompted the U.S. Pharmacopeia to ask providers to include an “indication for use” on prescriptions.

The recommendation is in U.S. Pharmacopeia's eighth annual MEDMARX report, which is based on a review of more than 26,000 records submitted to the MEDMARX database from 2003 to 2006.

The records implicate nearly 1,500 drugs in medication errors due to brand or generic names that could be confused. From these data, U.S. Pharmacopeia (USP) compiled a list of more than 3,000 drug pairs that look or sound alike, nearly double the number of pairs identified in USP's 2004 report, said Diane Cousins, R.Ph.

USP also operates, in conjunction with the Institute for Safe Medication Practices, the Medication Errors Reporting Program (MER), which allows health care professioals to report confidentially potential and actual medication errors directly to USP.

USP reviewed both MEDMARX and MER to summarize the variables associated with more than 26,000 look-alike and/or sound-alike (LASA) errors, of which 1.4% (384) resulted in harm or death. More than 670 health care facilities contributed 26,000 records, according to the report.

“We looked at lists of the top 200 drugs prescribed and used in hospitals, and virtually every time, all of the top 10 appeared within the USP similar names list,” said Ms. Cousins, USP's vice president of health care quality and information.

“Although pharmacy personnel, who are generally technicians, made the majority of errors, pharmacists as a group identified, prevented, and reported more than any other staff,” she said.

The report also identifies an emerging trend of look-alike drug names in computerized direct order entry systems. She added the LASA-related error problem is further compounded by the indiscriminate use of suffixes, as well as look-alike packaging and labeling.

Over the 3-year period, the drug most commonly confused with others was Cefazolin, a first-generation cephalosporin antibiotic. “We found it to be confused with 15 other drugs, primarily antimicrobials, which might be explained by the fact that this is the most frequently used class of medications,” said Ms. Cousins.

Drug mix-ups led to seven reported fatalities, including two due to confusion over the Alzheimer's drug Reminyl (galantamine) and the antidiabetes drug Amaryl (glimepiride).

In 2005, recognizing the high risk of confusion and subsequent fatal hypoglycemia, Ortho-McNeil Neurologics Inc. announced that the name Reminyl had been changed to Razadyne to avoid confusion with Amaryl. In another case, a physician was preparing to intubate a patient and calculated the dose for rocuronium (Zemuron), a preintubation agent used to assist with the procedure. The physician gave orders for the nurse to obtain the medication and indicated the volume to administer to the patient. The nurse obtained and administered the neuromuscular blocking agent vecuronium (Norcuron) instead, leading to a fatal heart arrhythmia.

Other deaths involved mix-ups between the anticonvulsant primidone and prednisone; the antiepileptic drug phenytoin sodium and the barbiturate phenobarbital; and Norcuron and the heart failure treatment Natrecor (nesiritide recombinant).

Errors occur with over-the-counter medications, too. Ms. Cousins described the aural confusion when an order for Ferro-Sequel 500 mg—an iron replacement—was transcribed as Serrosequel 500 mg and the order was misread as Seroquel 500 mg—an antipsychotic.

The rate of mix-ups involving brand name versus generic drugs was about evenly split, 57% and 43%, respectively, Ms. Cousins said, adding that while most errors were made in pharmacies, many are due to confusion over the prescribing physician's handwriting.

“Errors also are due to physicians using short codes for medications, such as 'clon,' for clonazepam or clonapine,” she said, adding that electronically written prescriptions using a computer or label machine would eliminate many errors.

It would also be helpful if the FDA were given more authority to force name changes during the drug review process.

The recommendation that physicians include indications for use in their prescriptions is not an attempt to impose on privacy, Ms. Cousins said. “All that is needed are simple inclusions, such as 'for sinus,' 'for heart,' or, 'for cough,'” she said. This also would help patients avoid confusion.

USP also recommends that “tall man lettering” be implemented in pharmacy software, labeling, and order writing to say, for example, “acetaZOLamide” (glaucoma) and “acetoHEXamide” (diabetes).

Where risk exists, USP recommends:

▸ Consider the potential for mix-ups before adding a drug to your formulary.

▸ Physically separate or differentiate products with similar names while they are being stored on the shelf.

▸ Disseminate information about products that have been confused at your facility, to build awareness among staff.

▸ Prohibit verbal orders for sound-alikes that have been mixed up at your facility.

 

 

“Physicians' offices should always require a read-back from pharmacists, making sure that they both say and spell the drug name,” Ms. Cousins said.

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Rise in ASD Repair Fueled by Percutaneous Closure

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Rise in ASD Repair Fueled by Percutaneous Closure

FORT LAUDERDALE, FLA. — A steep rise in secundum atrial septal defect repair in U.S. hospitals is being driven by a similarly dramatic shift toward percutaneous closure, mostly in older patients.

“The perceived decreased morbidity of percutaneous closure, coupled with a lower threshold for repair, may be driving increased utilization,” according to Dr. Tara Karamlou of the Oregon Health and Science University, Portland.

“However, what is surprising is that the technology was adopted so rapidly nationwide and in an older population in which one could question the appropriateness of device closures,” she said. “My suspicion is that these patients are coming in for coronary disease, getting a screening echocardiogram or cardiac catheterization that incidentally finds a small atrial septal defect, and that prompts device closure.”

Dr. Karamlou and her colleagues investigated nationwide trends in percutaneous closure (PC) use compared to surgical closure (SC) and their outcomes over 17 years. Using the Nationwide Inpatient Sample and ICD-9 procedure and diagnosis codes, they identified all atrial septal defect (ASD) closures performed from 1988 to 2005.

Over this period, the authors identified more than 15,000 secundum ASD closures, yielding a national estimate of 80,000 closures. Of these, 5,500 (national estimate 27,500) were percutaneous, and more than 10,000 (national estimate 54,000) were surgical. The remaining closures were of unspecified or undetermined type, Dr. Karamlou said at the annual meeting of the Society of Thoracic Surgeons.

Per capita, ASD closures increased dramatically from 1.08 per 10,000 population in 1988 to 2.59 per 10,000 in 2005. Surgical closures increased over the period from 0.86 to 1.07 per 100,000, whereas PC increased from 0.04 to 1.43 per 100,000, Dr. Karamlou reported.

Age was an important and statistically significant determinant of repair type, with younger patients preferentially treated with surgical repair. “Importantly, there was a shift in the demographics of the patient population over time, favoring ASD closure in older patients,” the authors said. This shift was noted in both closure types, but was more pronounced for PC, they said, adding that for PC, the mean age had increased from 12 years in 1988 to 42 years in 2005. The mean age for surgical closure increased from 26.5 to 27 years.

“This logarithmic increase in ASD closures was very surprising and unexpected,” Dr. Karamlou said in an interview. “Percutaneous closure was introduced in the early 1980s, and there was a significant lag before it took off. Then, around 2001, we started seeing a yearly doubling that gained momentum in 2004 and 2005.”

“The prolific increase in ASD closure rates therefore is due almost exclusively to treatment of older patients, aged 40–49,” Dr. Karamlou said.

The investigators identified 23 (national estimate 119) in-hospital deaths among PC patients and 84 (national estimate 472) deaths among patients undergoing surgical closure. Over the study period, crude mortality rates remained virtually the same for the two closure approaches.

The fact that mean hospital length of stay was twice as long for surgical closure (6 days vs. 3 days) must be viewed in light of the fact that PC patients were older and had fewer noncardiac anomalies than did those undergoing surgical closure, Dr. Karamlou cautioned.

That the data show a decrease in the ages of patients undergoing device closures in large centers suggests that large centers “are using device closures more appropriately,” Dr. Karamlou said in an interview. “But in general, PC closure devices are being used in an older patient population that one could argue really don't need to have their defects closed, and in the past, when surgery was the only option, these patients certainly would not have undergone closure.”

Dr. Karamlou concluded that, in the absence of meaningful benchmarks, prospective studies comparing outcomes, criteria, and cost for SC vs. PC are needed to determine whether increased atrial septal defect closure rates are justified.

“Assuming that the overall incidence of ASD is constant over time, the dramatic increase in ASD closure per capita suggests that increased utilization underlies this phenomenon, rather than an appropriate response to increased disease prevalence within the national population.”

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FORT LAUDERDALE, FLA. — A steep rise in secundum atrial septal defect repair in U.S. hospitals is being driven by a similarly dramatic shift toward percutaneous closure, mostly in older patients.

“The perceived decreased morbidity of percutaneous closure, coupled with a lower threshold for repair, may be driving increased utilization,” according to Dr. Tara Karamlou of the Oregon Health and Science University, Portland.

“However, what is surprising is that the technology was adopted so rapidly nationwide and in an older population in which one could question the appropriateness of device closures,” she said. “My suspicion is that these patients are coming in for coronary disease, getting a screening echocardiogram or cardiac catheterization that incidentally finds a small atrial septal defect, and that prompts device closure.”

Dr. Karamlou and her colleagues investigated nationwide trends in percutaneous closure (PC) use compared to surgical closure (SC) and their outcomes over 17 years. Using the Nationwide Inpatient Sample and ICD-9 procedure and diagnosis codes, they identified all atrial septal defect (ASD) closures performed from 1988 to 2005.

Over this period, the authors identified more than 15,000 secundum ASD closures, yielding a national estimate of 80,000 closures. Of these, 5,500 (national estimate 27,500) were percutaneous, and more than 10,000 (national estimate 54,000) were surgical. The remaining closures were of unspecified or undetermined type, Dr. Karamlou said at the annual meeting of the Society of Thoracic Surgeons.

Per capita, ASD closures increased dramatically from 1.08 per 10,000 population in 1988 to 2.59 per 10,000 in 2005. Surgical closures increased over the period from 0.86 to 1.07 per 100,000, whereas PC increased from 0.04 to 1.43 per 100,000, Dr. Karamlou reported.

Age was an important and statistically significant determinant of repair type, with younger patients preferentially treated with surgical repair. “Importantly, there was a shift in the demographics of the patient population over time, favoring ASD closure in older patients,” the authors said. This shift was noted in both closure types, but was more pronounced for PC, they said, adding that for PC, the mean age had increased from 12 years in 1988 to 42 years in 2005. The mean age for surgical closure increased from 26.5 to 27 years.

“This logarithmic increase in ASD closures was very surprising and unexpected,” Dr. Karamlou said in an interview. “Percutaneous closure was introduced in the early 1980s, and there was a significant lag before it took off. Then, around 2001, we started seeing a yearly doubling that gained momentum in 2004 and 2005.”

“The prolific increase in ASD closure rates therefore is due almost exclusively to treatment of older patients, aged 40–49,” Dr. Karamlou said.

The investigators identified 23 (national estimate 119) in-hospital deaths among PC patients and 84 (national estimate 472) deaths among patients undergoing surgical closure. Over the study period, crude mortality rates remained virtually the same for the two closure approaches.

The fact that mean hospital length of stay was twice as long for surgical closure (6 days vs. 3 days) must be viewed in light of the fact that PC patients were older and had fewer noncardiac anomalies than did those undergoing surgical closure, Dr. Karamlou cautioned.

That the data show a decrease in the ages of patients undergoing device closures in large centers suggests that large centers “are using device closures more appropriately,” Dr. Karamlou said in an interview. “But in general, PC closure devices are being used in an older patient population that one could argue really don't need to have their defects closed, and in the past, when surgery was the only option, these patients certainly would not have undergone closure.”

Dr. Karamlou concluded that, in the absence of meaningful benchmarks, prospective studies comparing outcomes, criteria, and cost for SC vs. PC are needed to determine whether increased atrial septal defect closure rates are justified.

“Assuming that the overall incidence of ASD is constant over time, the dramatic increase in ASD closure per capita suggests that increased utilization underlies this phenomenon, rather than an appropriate response to increased disease prevalence within the national population.”

FORT LAUDERDALE, FLA. — A steep rise in secundum atrial septal defect repair in U.S. hospitals is being driven by a similarly dramatic shift toward percutaneous closure, mostly in older patients.

“The perceived decreased morbidity of percutaneous closure, coupled with a lower threshold for repair, may be driving increased utilization,” according to Dr. Tara Karamlou of the Oregon Health and Science University, Portland.

“However, what is surprising is that the technology was adopted so rapidly nationwide and in an older population in which one could question the appropriateness of device closures,” she said. “My suspicion is that these patients are coming in for coronary disease, getting a screening echocardiogram or cardiac catheterization that incidentally finds a small atrial septal defect, and that prompts device closure.”

Dr. Karamlou and her colleagues investigated nationwide trends in percutaneous closure (PC) use compared to surgical closure (SC) and their outcomes over 17 years. Using the Nationwide Inpatient Sample and ICD-9 procedure and diagnosis codes, they identified all atrial septal defect (ASD) closures performed from 1988 to 2005.

Over this period, the authors identified more than 15,000 secundum ASD closures, yielding a national estimate of 80,000 closures. Of these, 5,500 (national estimate 27,500) were percutaneous, and more than 10,000 (national estimate 54,000) were surgical. The remaining closures were of unspecified or undetermined type, Dr. Karamlou said at the annual meeting of the Society of Thoracic Surgeons.

Per capita, ASD closures increased dramatically from 1.08 per 10,000 population in 1988 to 2.59 per 10,000 in 2005. Surgical closures increased over the period from 0.86 to 1.07 per 100,000, whereas PC increased from 0.04 to 1.43 per 100,000, Dr. Karamlou reported.

Age was an important and statistically significant determinant of repair type, with younger patients preferentially treated with surgical repair. “Importantly, there was a shift in the demographics of the patient population over time, favoring ASD closure in older patients,” the authors said. This shift was noted in both closure types, but was more pronounced for PC, they said, adding that for PC, the mean age had increased from 12 years in 1988 to 42 years in 2005. The mean age for surgical closure increased from 26.5 to 27 years.

“This logarithmic increase in ASD closures was very surprising and unexpected,” Dr. Karamlou said in an interview. “Percutaneous closure was introduced in the early 1980s, and there was a significant lag before it took off. Then, around 2001, we started seeing a yearly doubling that gained momentum in 2004 and 2005.”

“The prolific increase in ASD closure rates therefore is due almost exclusively to treatment of older patients, aged 40–49,” Dr. Karamlou said.

The investigators identified 23 (national estimate 119) in-hospital deaths among PC patients and 84 (national estimate 472) deaths among patients undergoing surgical closure. Over the study period, crude mortality rates remained virtually the same for the two closure approaches.

The fact that mean hospital length of stay was twice as long for surgical closure (6 days vs. 3 days) must be viewed in light of the fact that PC patients were older and had fewer noncardiac anomalies than did those undergoing surgical closure, Dr. Karamlou cautioned.

That the data show a decrease in the ages of patients undergoing device closures in large centers suggests that large centers “are using device closures more appropriately,” Dr. Karamlou said in an interview. “But in general, PC closure devices are being used in an older patient population that one could argue really don't need to have their defects closed, and in the past, when surgery was the only option, these patients certainly would not have undergone closure.”

Dr. Karamlou concluded that, in the absence of meaningful benchmarks, prospective studies comparing outcomes, criteria, and cost for SC vs. PC are needed to determine whether increased atrial septal defect closure rates are justified.

“Assuming that the overall incidence of ASD is constant over time, the dramatic increase in ASD closure per capita suggests that increased utilization underlies this phenomenon, rather than an appropriate response to increased disease prevalence within the national population.”

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MRI Could Rival Chest X-Ray in Pediatric Lung Disease Assessment

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MRI Could Rival Chest X-Ray in Pediatric Lung Disease Assessment

CHICAGO — Optimized low-field magnetic resonance imaging has the potential to replace plain chest radiographs in the assessment of lung disease in children, according to results of a poster study presented at the annual meeting of the Radiological Society of North America.

“The goal is to reduce radiation exposure for these very young patients—many with cystic fibrosis—while visualizing pathologies such as pneumonia and atelectasis,” Dr. Joachim Bernhardt, lead author, said in an interview. “We achieved that goal in about half of the 12 children involved in our study.”

A total of 48 examinations were conducted in nine boys and three girls, mean age 4 years, with pathologic lung alterations using a Magnetom open 0.2-tesla scanner (Siemens, Germany). Images were acquired with interleaved multislice 2-D and 3-D gradient echo sequences in combination with standard steady state MRI, said Dr. Bernhardt of the University of Würzburg (Germany).

Imaging allowed localization of presented pathologies and resulted in a modification of the therapeutic regimen in 5 of 12 patients.

In addition, the researchers were able to dispense with bronchoscopy in 5 of 12 patients, and antibiotic therapy was changed in 4 of those 5 children because MR images could differentiate between atelectasis and pneumonia, said Dr. Maynard Beer, senior investigator, who outlined the distinct advantages of low-field MRI.

“For example, image artifacts are reduced when field strength is reduced, so we get more reliable images,” Dr. Beer, also of the University of Würzburg, said in an interview.

Because the images are acquired so quickly and the open machine allows a parent to sit next to the child in full view, sedation is unnecessary, Dr. Beer said, adding that even when the baby or child is crying and moving, image integration produces good clinical results.

The use of the MRI influenced clinical therapy in nearly half of this small group of patients, the investigators concluded.

Neither physician had conflicts of interest to disclose.

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CHICAGO — Optimized low-field magnetic resonance imaging has the potential to replace plain chest radiographs in the assessment of lung disease in children, according to results of a poster study presented at the annual meeting of the Radiological Society of North America.

“The goal is to reduce radiation exposure for these very young patients—many with cystic fibrosis—while visualizing pathologies such as pneumonia and atelectasis,” Dr. Joachim Bernhardt, lead author, said in an interview. “We achieved that goal in about half of the 12 children involved in our study.”

A total of 48 examinations were conducted in nine boys and three girls, mean age 4 years, with pathologic lung alterations using a Magnetom open 0.2-tesla scanner (Siemens, Germany). Images were acquired with interleaved multislice 2-D and 3-D gradient echo sequences in combination with standard steady state MRI, said Dr. Bernhardt of the University of Würzburg (Germany).

Imaging allowed localization of presented pathologies and resulted in a modification of the therapeutic regimen in 5 of 12 patients.

In addition, the researchers were able to dispense with bronchoscopy in 5 of 12 patients, and antibiotic therapy was changed in 4 of those 5 children because MR images could differentiate between atelectasis and pneumonia, said Dr. Maynard Beer, senior investigator, who outlined the distinct advantages of low-field MRI.

“For example, image artifacts are reduced when field strength is reduced, so we get more reliable images,” Dr. Beer, also of the University of Würzburg, said in an interview.

Because the images are acquired so quickly and the open machine allows a parent to sit next to the child in full view, sedation is unnecessary, Dr. Beer said, adding that even when the baby or child is crying and moving, image integration produces good clinical results.

The use of the MRI influenced clinical therapy in nearly half of this small group of patients, the investigators concluded.

Neither physician had conflicts of interest to disclose.

CHICAGO — Optimized low-field magnetic resonance imaging has the potential to replace plain chest radiographs in the assessment of lung disease in children, according to results of a poster study presented at the annual meeting of the Radiological Society of North America.

“The goal is to reduce radiation exposure for these very young patients—many with cystic fibrosis—while visualizing pathologies such as pneumonia and atelectasis,” Dr. Joachim Bernhardt, lead author, said in an interview. “We achieved that goal in about half of the 12 children involved in our study.”

A total of 48 examinations were conducted in nine boys and three girls, mean age 4 years, with pathologic lung alterations using a Magnetom open 0.2-tesla scanner (Siemens, Germany). Images were acquired with interleaved multislice 2-D and 3-D gradient echo sequences in combination with standard steady state MRI, said Dr. Bernhardt of the University of Würzburg (Germany).

Imaging allowed localization of presented pathologies and resulted in a modification of the therapeutic regimen in 5 of 12 patients.

In addition, the researchers were able to dispense with bronchoscopy in 5 of 12 patients, and antibiotic therapy was changed in 4 of those 5 children because MR images could differentiate between atelectasis and pneumonia, said Dr. Maynard Beer, senior investigator, who outlined the distinct advantages of low-field MRI.

“For example, image artifacts are reduced when field strength is reduced, so we get more reliable images,” Dr. Beer, also of the University of Würzburg, said in an interview.

Because the images are acquired so quickly and the open machine allows a parent to sit next to the child in full view, sedation is unnecessary, Dr. Beer said, adding that even when the baby or child is crying and moving, image integration produces good clinical results.

The use of the MRI influenced clinical therapy in nearly half of this small group of patients, the investigators concluded.

Neither physician had conflicts of interest to disclose.

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OCs Protect Against Ovarian Cancer Long Term

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OCs Protect Against Ovarian Cancer Long Term

The use of oral contraceptives confers long-term protection against ovarian cancer, and the longer birth control pills are used, the greater their protective effect, according to an analysis of 45 epidemiologic studies from around the world.

The findings suggest that oral contraceptives (OCs) have prevented about 200,000 ovarian cancers and 100,000 deaths from the disease worldwide during the past half century. In coming decades, the number of cancers prevented will rise to an estimated 30,000 per year, according to the Collaborative Group on Epidemiological Studies of Ovarian Cancer, led by Dr. Valerie Beral of the Cancer Research UK Epidemiology Unit at Oxford (England) University. (Lancet 2008;371:303–14).

Noting that the findings are not unexpected, the editors of the Lancet called the study “impressive and compelling.” The findings “set a new standard in primary prevention for a deadly cancer and have important public health implications,” they wrote in an editorial (Lancet 2008;371:275).

The collaborative analysis “brings unequivocal good news,” Dr. Eduardo L. Franco and Dr. Eliane Duarte-Franco wrote in a commentary (Lancet 2008;371:277–8). “Women and their health-care providers are once again at a balancing act of judging risks versus benefits.”

The analysis included 13 prospective studies, 19 case-control studies with population controls, and 13 case-control studies with hospital controls. Conducted in 21 countries, the studies included 23,000 women with malignant epithelial or nonepithelial ovarian cancer and more than 87,000 controls without ovarian cancer who had not undergone bilateral oophorectomy. On average, the cancers were diagnosed in 1993, and the mean age at diagnosis was 56 years.

Overall, 31% of the women with ovarian cancer and 37% of the controls had used OCs for an average of 4.4 and 5 years, respectively. Ovarian cancer diagnoses, on average, were made about 20 years after the women first used OCs.

Each of the three types of study design yielded a highly significant reduction in the relative risk of ovarian cancer in OC users compared with never users. “The overall relative risk decreased by 20% for each 5 years of use,” the authors wrote. Women who had used OCs for about 15 years had a 50% risk reduction.

“The proportional declines in relative risk per 5 years [of OC] use were 29% for those whose use had ceased less than 10 years previously, 19% for use ceased 10–19 years previously, and 15% for use ceased 20–29 years previously,” they reported.

In high-income countries, 10 years of OC use reduced ovarian cancer incidence before age 75 from 12 per 1,000 women to 8 per 1,000, and mortality from 7 per 1,000 women to 5 per 1,000, the researchers estimated.

There was limited evidence that OC use prevents mucinous ovarian cancer, which accounts for fewer than 15% of all cases, commented Dr. Franco of the department of oncology and epidemiology, McGill University, Montreal, and Dr. Duarte-Franco of the Institut National de Santé Publique du Québec, also in Montreal.

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The use of oral contraceptives confers long-term protection against ovarian cancer, and the longer birth control pills are used, the greater their protective effect, according to an analysis of 45 epidemiologic studies from around the world.

The findings suggest that oral contraceptives (OCs) have prevented about 200,000 ovarian cancers and 100,000 deaths from the disease worldwide during the past half century. In coming decades, the number of cancers prevented will rise to an estimated 30,000 per year, according to the Collaborative Group on Epidemiological Studies of Ovarian Cancer, led by Dr. Valerie Beral of the Cancer Research UK Epidemiology Unit at Oxford (England) University. (Lancet 2008;371:303–14).

Noting that the findings are not unexpected, the editors of the Lancet called the study “impressive and compelling.” The findings “set a new standard in primary prevention for a deadly cancer and have important public health implications,” they wrote in an editorial (Lancet 2008;371:275).

The collaborative analysis “brings unequivocal good news,” Dr. Eduardo L. Franco and Dr. Eliane Duarte-Franco wrote in a commentary (Lancet 2008;371:277–8). “Women and their health-care providers are once again at a balancing act of judging risks versus benefits.”

The analysis included 13 prospective studies, 19 case-control studies with population controls, and 13 case-control studies with hospital controls. Conducted in 21 countries, the studies included 23,000 women with malignant epithelial or nonepithelial ovarian cancer and more than 87,000 controls without ovarian cancer who had not undergone bilateral oophorectomy. On average, the cancers were diagnosed in 1993, and the mean age at diagnosis was 56 years.

Overall, 31% of the women with ovarian cancer and 37% of the controls had used OCs for an average of 4.4 and 5 years, respectively. Ovarian cancer diagnoses, on average, were made about 20 years after the women first used OCs.

Each of the three types of study design yielded a highly significant reduction in the relative risk of ovarian cancer in OC users compared with never users. “The overall relative risk decreased by 20% for each 5 years of use,” the authors wrote. Women who had used OCs for about 15 years had a 50% risk reduction.

“The proportional declines in relative risk per 5 years [of OC] use were 29% for those whose use had ceased less than 10 years previously, 19% for use ceased 10–19 years previously, and 15% for use ceased 20–29 years previously,” they reported.

In high-income countries, 10 years of OC use reduced ovarian cancer incidence before age 75 from 12 per 1,000 women to 8 per 1,000, and mortality from 7 per 1,000 women to 5 per 1,000, the researchers estimated.

There was limited evidence that OC use prevents mucinous ovarian cancer, which accounts for fewer than 15% of all cases, commented Dr. Franco of the department of oncology and epidemiology, McGill University, Montreal, and Dr. Duarte-Franco of the Institut National de Santé Publique du Québec, also in Montreal.

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The use of oral contraceptives confers long-term protection against ovarian cancer, and the longer birth control pills are used, the greater their protective effect, according to an analysis of 45 epidemiologic studies from around the world.

The findings suggest that oral contraceptives (OCs) have prevented about 200,000 ovarian cancers and 100,000 deaths from the disease worldwide during the past half century. In coming decades, the number of cancers prevented will rise to an estimated 30,000 per year, according to the Collaborative Group on Epidemiological Studies of Ovarian Cancer, led by Dr. Valerie Beral of the Cancer Research UK Epidemiology Unit at Oxford (England) University. (Lancet 2008;371:303–14).

Noting that the findings are not unexpected, the editors of the Lancet called the study “impressive and compelling.” The findings “set a new standard in primary prevention for a deadly cancer and have important public health implications,” they wrote in an editorial (Lancet 2008;371:275).

The collaborative analysis “brings unequivocal good news,” Dr. Eduardo L. Franco and Dr. Eliane Duarte-Franco wrote in a commentary (Lancet 2008;371:277–8). “Women and their health-care providers are once again at a balancing act of judging risks versus benefits.”

The analysis included 13 prospective studies, 19 case-control studies with population controls, and 13 case-control studies with hospital controls. Conducted in 21 countries, the studies included 23,000 women with malignant epithelial or nonepithelial ovarian cancer and more than 87,000 controls without ovarian cancer who had not undergone bilateral oophorectomy. On average, the cancers were diagnosed in 1993, and the mean age at diagnosis was 56 years.

Overall, 31% of the women with ovarian cancer and 37% of the controls had used OCs for an average of 4.4 and 5 years, respectively. Ovarian cancer diagnoses, on average, were made about 20 years after the women first used OCs.

Each of the three types of study design yielded a highly significant reduction in the relative risk of ovarian cancer in OC users compared with never users. “The overall relative risk decreased by 20% for each 5 years of use,” the authors wrote. Women who had used OCs for about 15 years had a 50% risk reduction.

“The proportional declines in relative risk per 5 years [of OC] use were 29% for those whose use had ceased less than 10 years previously, 19% for use ceased 10–19 years previously, and 15% for use ceased 20–29 years previously,” they reported.

In high-income countries, 10 years of OC use reduced ovarian cancer incidence before age 75 from 12 per 1,000 women to 8 per 1,000, and mortality from 7 per 1,000 women to 5 per 1,000, the researchers estimated.

There was limited evidence that OC use prevents mucinous ovarian cancer, which accounts for fewer than 15% of all cases, commented Dr. Franco of the department of oncology and epidemiology, McGill University, Montreal, and Dr. Duarte-Franco of the Institut National de Santé Publique du Québec, also in Montreal.

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Chronic Pain Worse Among Emergency Department Patients

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CHICAGO – Emergency department patients with a history of chronic pain rate their pain as more severe than acute pain patients do, based on a prospective, observational study conducted in 20 emergency departments, said Dr. Martha L. Neighbor at the annual meeting of the Society for Academic Emergency Medicine.

Furthermore, chronic pain associated with headache, migraine, back pain, cancer, sickle cell disease, substance abuse, and psychiatric disorders is highly prevalent in the ED, said Dr. Neighbor of San Francisco General Hospital and professor of medicine at the University of California, San Francisco.

Most of the 50 million Americans with chronic pain will have breakthrough pain, and many will seek ED care, Dr. Neighbor said in an interview, adding that little is known about this subgroup of patients.

In a prospective, observational study of 246 chronic pain patients and 389 acute pain patients at 20 EDs in the United States and Canada, patients with chronic pain had dissatisfaction scores of 4.9%, compared with dissatisfaction scores of 4.7% for those patients with acute pain.

Data were derived from structured interviews, medical record abstraction, and telephone follow-up. All patients had moderate to severe pain (numerical rating scale, or NRS, of 4 or greater on a scale of 10) and were enrolled during six 8-hour shifts over 2-week periods with all shifts of the 24-hour cycle represented, Dr. Neighbor explained.

When the patients were asked why they came to the ED, 56% said they were there because of chronic pain, which was defined as continuous or intermittent pain of 1 month or longer duration, she said.

Patients with chronic pain had significantly more severe pain at all time measurements, from arrival in the ED through discharge to a 1-week telephone follow-up. On arrival in the ED, the median NRS was 8.0 in the chronic pain group and 7.5 in the acute pain group. On discharge, the pain ratings were 6.1 and 5.2, respectively. And at follow-up, they were 3.7 and 2.1, respectively.

In examining analgesia differences, the investigators found that patients with chronic pain were more likely than patients with acute pain to:

▸ Feel the need for analgesics (77% vs. 67%).

▸ Ask for analgesics (33% vs. 22%).

▸ Report that they have allergies to analgesics (19% vs. 5%).

▸ Take analgesics both at ED presentation (37% vs. 17%) and at follow-up (87% vs. 79%).

“Patients with chronic pain are experiencing more severe pain than acute pain patients do,” Dr. Neighbor said in an interview.

Because they typically are taking analgesics, they “may be more challenging to deal with as far as improving their pain care is concerned.”

Fortunately, at least in the ED setting, those patients are just as likely as acute pain sufferers to receive analgesics. Whether improvements in ED pain management practice will lead to better outcomes in this population is unknown, she concluded.

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CHICAGO – Emergency department patients with a history of chronic pain rate their pain as more severe than acute pain patients do, based on a prospective, observational study conducted in 20 emergency departments, said Dr. Martha L. Neighbor at the annual meeting of the Society for Academic Emergency Medicine.

Furthermore, chronic pain associated with headache, migraine, back pain, cancer, sickle cell disease, substance abuse, and psychiatric disorders is highly prevalent in the ED, said Dr. Neighbor of San Francisco General Hospital and professor of medicine at the University of California, San Francisco.

Most of the 50 million Americans with chronic pain will have breakthrough pain, and many will seek ED care, Dr. Neighbor said in an interview, adding that little is known about this subgroup of patients.

In a prospective, observational study of 246 chronic pain patients and 389 acute pain patients at 20 EDs in the United States and Canada, patients with chronic pain had dissatisfaction scores of 4.9%, compared with dissatisfaction scores of 4.7% for those patients with acute pain.

Data were derived from structured interviews, medical record abstraction, and telephone follow-up. All patients had moderate to severe pain (numerical rating scale, or NRS, of 4 or greater on a scale of 10) and were enrolled during six 8-hour shifts over 2-week periods with all shifts of the 24-hour cycle represented, Dr. Neighbor explained.

When the patients were asked why they came to the ED, 56% said they were there because of chronic pain, which was defined as continuous or intermittent pain of 1 month or longer duration, she said.

Patients with chronic pain had significantly more severe pain at all time measurements, from arrival in the ED through discharge to a 1-week telephone follow-up. On arrival in the ED, the median NRS was 8.0 in the chronic pain group and 7.5 in the acute pain group. On discharge, the pain ratings were 6.1 and 5.2, respectively. And at follow-up, they were 3.7 and 2.1, respectively.

In examining analgesia differences, the investigators found that patients with chronic pain were more likely than patients with acute pain to:

▸ Feel the need for analgesics (77% vs. 67%).

▸ Ask for analgesics (33% vs. 22%).

▸ Report that they have allergies to analgesics (19% vs. 5%).

▸ Take analgesics both at ED presentation (37% vs. 17%) and at follow-up (87% vs. 79%).

“Patients with chronic pain are experiencing more severe pain than acute pain patients do,” Dr. Neighbor said in an interview.

Because they typically are taking analgesics, they “may be more challenging to deal with as far as improving their pain care is concerned.”

Fortunately, at least in the ED setting, those patients are just as likely as acute pain sufferers to receive analgesics. Whether improvements in ED pain management practice will lead to better outcomes in this population is unknown, she concluded.

CHICAGO – Emergency department patients with a history of chronic pain rate their pain as more severe than acute pain patients do, based on a prospective, observational study conducted in 20 emergency departments, said Dr. Martha L. Neighbor at the annual meeting of the Society for Academic Emergency Medicine.

Furthermore, chronic pain associated with headache, migraine, back pain, cancer, sickle cell disease, substance abuse, and psychiatric disorders is highly prevalent in the ED, said Dr. Neighbor of San Francisco General Hospital and professor of medicine at the University of California, San Francisco.

Most of the 50 million Americans with chronic pain will have breakthrough pain, and many will seek ED care, Dr. Neighbor said in an interview, adding that little is known about this subgroup of patients.

In a prospective, observational study of 246 chronic pain patients and 389 acute pain patients at 20 EDs in the United States and Canada, patients with chronic pain had dissatisfaction scores of 4.9%, compared with dissatisfaction scores of 4.7% for those patients with acute pain.

Data were derived from structured interviews, medical record abstraction, and telephone follow-up. All patients had moderate to severe pain (numerical rating scale, or NRS, of 4 or greater on a scale of 10) and were enrolled during six 8-hour shifts over 2-week periods with all shifts of the 24-hour cycle represented, Dr. Neighbor explained.

When the patients were asked why they came to the ED, 56% said they were there because of chronic pain, which was defined as continuous or intermittent pain of 1 month or longer duration, she said.

Patients with chronic pain had significantly more severe pain at all time measurements, from arrival in the ED through discharge to a 1-week telephone follow-up. On arrival in the ED, the median NRS was 8.0 in the chronic pain group and 7.5 in the acute pain group. On discharge, the pain ratings were 6.1 and 5.2, respectively. And at follow-up, they were 3.7 and 2.1, respectively.

In examining analgesia differences, the investigators found that patients with chronic pain were more likely than patients with acute pain to:

▸ Feel the need for analgesics (77% vs. 67%).

▸ Ask for analgesics (33% vs. 22%).

▸ Report that they have allergies to analgesics (19% vs. 5%).

▸ Take analgesics both at ED presentation (37% vs. 17%) and at follow-up (87% vs. 79%).

“Patients with chronic pain are experiencing more severe pain than acute pain patients do,” Dr. Neighbor said in an interview.

Because they typically are taking analgesics, they “may be more challenging to deal with as far as improving their pain care is concerned.”

Fortunately, at least in the ED setting, those patients are just as likely as acute pain sufferers to receive analgesics. Whether improvements in ED pain management practice will lead to better outcomes in this population is unknown, she concluded.

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Chest Radiographs May Be Overused in Severe Pneumonia

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Chest Radiographs May Be Overused in Severe Pneumonia

CHICAGO — Routine follow-up chest radiography may not be appropriate for patients with severe community-acquired pneumonia who clinically respond to initial antibiotic therapy, according to a multicenter study presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

“In addition, chest radiographs obtained prior to hospital discharge, as advised by the American Thoracic Society in their 1993 guideline, seem to be unnecessary,” according to the authors, whose study was published shortly after the conference (Clin. Infect. Dis. 2007;45:983–91).

The use of follow-up chest x-rays of patients hospitalized for severe community-acquired pneumonia (CAP) has become common clinical practice, and the absence of guidelines leaves physicians reliant on recommendations derived from grade D evidence, said lead author and presenter Dr. Anke H.W. Bruns, a research fellow in the department of internal medicine and infectious diseases at the University Medical Center Utrecht (the Netherlands).

“Furthermore, the timing of those follow-up chest x-rays is difficult, in part because we know little about time-to-resolution of findings related to infection on a film,” she said. “So, follow-up radiographs probably are ordered unnecessarily.”

To address this question, the researchers studied 288 patients enrolled between July 2000 and June 2003 from a prospective randomized trial on the cost-effectiveness of an early switch from parenteral to oral therapy for severe CAP.

The mean age of the patients was 70 years, and two-thirds were men. The mean pneumonia severity index at admission was 113, half the patients had comorbidities, and virtually all patients had been placed on a β-lactam (82%) or β-lactam-macrolide combination (14%).

Of the 140 cases with proven microbiological etiology, 44% had Streptococcus pneumoniae. Another 20% had atypical pathogens, including Mycoplasma pneumoniae, Chlamydia pneumoniae, and Legionella pneumophila. The remaining 36% were infected with unidentified pathogens, Dr. Bruns explained.

Patients were observed for a maximum of 28 days, and those who were still hospitalized on day 7 underwent follow-up chest radiography. After hospital discharge, all patients were asked to return to the outpatient clinic for clinical evaluation, blood chemistry analysis, and a chest radiograph at day 28. Scores for clinical improvement on day 7 and for clinical cure on day 28 were calculated for each patient. The cumulative dropout rate for radiographs was 21% at day 7 and 32% at day 28.

Radiologists reviewed the radiographs for the presence of pulmonary infiltrates, pleural fluid, atelectasis, pulmonary edema, and other findings. During follow-up, clearance of pulmonary infiltrates and resolution of chest radiograph abnormalities were established.

At 1 week, 33% of patients had clearance of pulmonary infiltrates, and only 25% demonstrated resolution of chest radiograph abnormalities. At 1 month, 62% of patients had clearance of infiltrates, and 53% had resolution of radiograph abnormalities. Resolution occurred more slowly in patients with proven S. pneumoniae pneumonia, the investigators reported.

Resolution of radiograph abnormalities lagged behind clinical improvement: At 1 week, clinical improvement was observed in more than half of patients, while resolution of chest radiograph abnormalities was seen in only one-quarter of patients. At 1 month, 78% of patients had clinical cures, and 53% showed resolution on radiographs.

The patients with radiographic deterioration were compared with those without radiographic deterioration for outcomes that included clinical cure at 1 month, mortality, and intervention during follow-up. “We saw no difference in any of those three parameters, so we can state that chest radiograph deterioration during follow-up was not associated with poor outcome,” Dr. Bruns said at the conference sponsored by the American Society for Microbiology.

Clinical parameters that independently predicted delayed resolution of chest radiograph findings at 1 week included dullness to percussion, multilobar disease, high respiratory rate, and high C-reactive protein (CRP) level. CRP level greater than 200 mg/L at admission also predicted delayed resolution of chest radiograph abnormalities at day 28.

The authors noted that the number of interventions in patients with deterioration of chest radiograph findings was comparable to the number of interventions in other patients, suggesting that physicians' decisions were not made solely on the basis of chest radiograph findings.

“Performing a chest x-ray to exclude a noninfectious cause of pneumonia within 4 weeks of initial diagnosis is not indicated, because at this point half of patients have radiographic findings that are a result of normal clinical course and do not necessarily indicate pathology,” Dr. Bruns said.

“Chest radiograph deterioration during follow-up was not associated with poor outcome, so in our opinion, routine in-hospital follow-up radiographs in severe CAP have no additional value,” she said.

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CHICAGO — Routine follow-up chest radiography may not be appropriate for patients with severe community-acquired pneumonia who clinically respond to initial antibiotic therapy, according to a multicenter study presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

“In addition, chest radiographs obtained prior to hospital discharge, as advised by the American Thoracic Society in their 1993 guideline, seem to be unnecessary,” according to the authors, whose study was published shortly after the conference (Clin. Infect. Dis. 2007;45:983–91).

The use of follow-up chest x-rays of patients hospitalized for severe community-acquired pneumonia (CAP) has become common clinical practice, and the absence of guidelines leaves physicians reliant on recommendations derived from grade D evidence, said lead author and presenter Dr. Anke H.W. Bruns, a research fellow in the department of internal medicine and infectious diseases at the University Medical Center Utrecht (the Netherlands).

“Furthermore, the timing of those follow-up chest x-rays is difficult, in part because we know little about time-to-resolution of findings related to infection on a film,” she said. “So, follow-up radiographs probably are ordered unnecessarily.”

To address this question, the researchers studied 288 patients enrolled between July 2000 and June 2003 from a prospective randomized trial on the cost-effectiveness of an early switch from parenteral to oral therapy for severe CAP.

The mean age of the patients was 70 years, and two-thirds were men. The mean pneumonia severity index at admission was 113, half the patients had comorbidities, and virtually all patients had been placed on a β-lactam (82%) or β-lactam-macrolide combination (14%).

Of the 140 cases with proven microbiological etiology, 44% had Streptococcus pneumoniae. Another 20% had atypical pathogens, including Mycoplasma pneumoniae, Chlamydia pneumoniae, and Legionella pneumophila. The remaining 36% were infected with unidentified pathogens, Dr. Bruns explained.

Patients were observed for a maximum of 28 days, and those who were still hospitalized on day 7 underwent follow-up chest radiography. After hospital discharge, all patients were asked to return to the outpatient clinic for clinical evaluation, blood chemistry analysis, and a chest radiograph at day 28. Scores for clinical improvement on day 7 and for clinical cure on day 28 were calculated for each patient. The cumulative dropout rate for radiographs was 21% at day 7 and 32% at day 28.

Radiologists reviewed the radiographs for the presence of pulmonary infiltrates, pleural fluid, atelectasis, pulmonary edema, and other findings. During follow-up, clearance of pulmonary infiltrates and resolution of chest radiograph abnormalities were established.

At 1 week, 33% of patients had clearance of pulmonary infiltrates, and only 25% demonstrated resolution of chest radiograph abnormalities. At 1 month, 62% of patients had clearance of infiltrates, and 53% had resolution of radiograph abnormalities. Resolution occurred more slowly in patients with proven S. pneumoniae pneumonia, the investigators reported.

Resolution of radiograph abnormalities lagged behind clinical improvement: At 1 week, clinical improvement was observed in more than half of patients, while resolution of chest radiograph abnormalities was seen in only one-quarter of patients. At 1 month, 78% of patients had clinical cures, and 53% showed resolution on radiographs.

The patients with radiographic deterioration were compared with those without radiographic deterioration for outcomes that included clinical cure at 1 month, mortality, and intervention during follow-up. “We saw no difference in any of those three parameters, so we can state that chest radiograph deterioration during follow-up was not associated with poor outcome,” Dr. Bruns said at the conference sponsored by the American Society for Microbiology.

Clinical parameters that independently predicted delayed resolution of chest radiograph findings at 1 week included dullness to percussion, multilobar disease, high respiratory rate, and high C-reactive protein (CRP) level. CRP level greater than 200 mg/L at admission also predicted delayed resolution of chest radiograph abnormalities at day 28.

The authors noted that the number of interventions in patients with deterioration of chest radiograph findings was comparable to the number of interventions in other patients, suggesting that physicians' decisions were not made solely on the basis of chest radiograph findings.

“Performing a chest x-ray to exclude a noninfectious cause of pneumonia within 4 weeks of initial diagnosis is not indicated, because at this point half of patients have radiographic findings that are a result of normal clinical course and do not necessarily indicate pathology,” Dr. Bruns said.

“Chest radiograph deterioration during follow-up was not associated with poor outcome, so in our opinion, routine in-hospital follow-up radiographs in severe CAP have no additional value,” she said.

CHICAGO — Routine follow-up chest radiography may not be appropriate for patients with severe community-acquired pneumonia who clinically respond to initial antibiotic therapy, according to a multicenter study presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

“In addition, chest radiographs obtained prior to hospital discharge, as advised by the American Thoracic Society in their 1993 guideline, seem to be unnecessary,” according to the authors, whose study was published shortly after the conference (Clin. Infect. Dis. 2007;45:983–91).

The use of follow-up chest x-rays of patients hospitalized for severe community-acquired pneumonia (CAP) has become common clinical practice, and the absence of guidelines leaves physicians reliant on recommendations derived from grade D evidence, said lead author and presenter Dr. Anke H.W. Bruns, a research fellow in the department of internal medicine and infectious diseases at the University Medical Center Utrecht (the Netherlands).

“Furthermore, the timing of those follow-up chest x-rays is difficult, in part because we know little about time-to-resolution of findings related to infection on a film,” she said. “So, follow-up radiographs probably are ordered unnecessarily.”

To address this question, the researchers studied 288 patients enrolled between July 2000 and June 2003 from a prospective randomized trial on the cost-effectiveness of an early switch from parenteral to oral therapy for severe CAP.

The mean age of the patients was 70 years, and two-thirds were men. The mean pneumonia severity index at admission was 113, half the patients had comorbidities, and virtually all patients had been placed on a β-lactam (82%) or β-lactam-macrolide combination (14%).

Of the 140 cases with proven microbiological etiology, 44% had Streptococcus pneumoniae. Another 20% had atypical pathogens, including Mycoplasma pneumoniae, Chlamydia pneumoniae, and Legionella pneumophila. The remaining 36% were infected with unidentified pathogens, Dr. Bruns explained.

Patients were observed for a maximum of 28 days, and those who were still hospitalized on day 7 underwent follow-up chest radiography. After hospital discharge, all patients were asked to return to the outpatient clinic for clinical evaluation, blood chemistry analysis, and a chest radiograph at day 28. Scores for clinical improvement on day 7 and for clinical cure on day 28 were calculated for each patient. The cumulative dropout rate for radiographs was 21% at day 7 and 32% at day 28.

Radiologists reviewed the radiographs for the presence of pulmonary infiltrates, pleural fluid, atelectasis, pulmonary edema, and other findings. During follow-up, clearance of pulmonary infiltrates and resolution of chest radiograph abnormalities were established.

At 1 week, 33% of patients had clearance of pulmonary infiltrates, and only 25% demonstrated resolution of chest radiograph abnormalities. At 1 month, 62% of patients had clearance of infiltrates, and 53% had resolution of radiograph abnormalities. Resolution occurred more slowly in patients with proven S. pneumoniae pneumonia, the investigators reported.

Resolution of radiograph abnormalities lagged behind clinical improvement: At 1 week, clinical improvement was observed in more than half of patients, while resolution of chest radiograph abnormalities was seen in only one-quarter of patients. At 1 month, 78% of patients had clinical cures, and 53% showed resolution on radiographs.

The patients with radiographic deterioration were compared with those without radiographic deterioration for outcomes that included clinical cure at 1 month, mortality, and intervention during follow-up. “We saw no difference in any of those three parameters, so we can state that chest radiograph deterioration during follow-up was not associated with poor outcome,” Dr. Bruns said at the conference sponsored by the American Society for Microbiology.

Clinical parameters that independently predicted delayed resolution of chest radiograph findings at 1 week included dullness to percussion, multilobar disease, high respiratory rate, and high C-reactive protein (CRP) level. CRP level greater than 200 mg/L at admission also predicted delayed resolution of chest radiograph abnormalities at day 28.

The authors noted that the number of interventions in patients with deterioration of chest radiograph findings was comparable to the number of interventions in other patients, suggesting that physicians' decisions were not made solely on the basis of chest radiograph findings.

“Performing a chest x-ray to exclude a noninfectious cause of pneumonia within 4 weeks of initial diagnosis is not indicated, because at this point half of patients have radiographic findings that are a result of normal clinical course and do not necessarily indicate pathology,” Dr. Bruns said.

“Chest radiograph deterioration during follow-up was not associated with poor outcome, so in our opinion, routine in-hospital follow-up radiographs in severe CAP have no additional value,” she said.

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FDA Grants New Cephalosporin Fast-Track Status

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Monotherapy with ceftobiprole was found to be as effective as vancomycin plus ceftazidime for treating patients with a broad range of complicated skin and skin-structure infections caused by gram-positive and gram-negative bacteria.

Following the completion of successful phase III registration trials, the Food and Drug Administration granted ceftobiprole fast-track status for the treatment of both complicated skin and skin-structure infections caused by methicillin-resistant staphylococci and hospital-acquired pneumonia.

Ceftobiprole is a novel, broad-spectrum cephalosporin developed jointly by Basilea Pharmaceutica AG and Cilag AG International (a Johnson & Johnson company).

The randomized, double-blind, multicenter trial included 828 patients with diabetic foot infections, abscess, cellulitis, and wound infection, reported Gary J. Noel and his fellow researchers, all full-time employees of Johnson & Johnson Pharmaceutical Research and Development, Raritan, N.J., which funded the study (Clin. Infect. Dis. 2008;46:647–55).

Infecting pathogen types—identified in at least 10 patients at baseline—included coagulase-negative and coagulase-positive staphylococci, Pseudomonas aeruginosa, β-hemolytic streptococci, and enterobacteriaceae. The most prevalent pathogens were gram-positive bacteria, specifically methicillin-resistant Staphylococcus aureus (MRSA) (123 patients) and methicillin-susceptible S. aureus (MSSA) (250 patients).

The patient cohort, accumulated over 129 international sites, was divided into two arms, with 547 patients receiving ceftobiprole and 281 receiving the glycopeptide antibiotic vancomycin plus the third-generation cephalosporin ceftazidime, according to the researchers.

Patients in the ceftobiprole arm received 500 mg for 120 minutes every 8 hours, while in the comparator group, the starting dose was 1,000 mg vancomycin infused over 60 minutes every 12 hours plus 1,000 mg ceftazidime infused over 120 minutes every 8 hours.

The mean duration of treatment in the clinically evaluable population was about 9 days in both arms, the authors noted.

At the investigating physicians' discretion, empirical treatment with metronidazole (Flagyl, Pfizer) was permitted to provide activity against anaerobic bacteria. The nitroimidazole anti-infective was given to 39 of the ceftobiprole-treated patients and 17 of the comparator-treated patients, the researchers wrote.

At the test-of-cure (TOC) visit (after 6–17 days of treatment) for the evaluable patients, clinical cure occurred for 439 of 485 (91%) ceftobiprole-treated patients and for 220 of 244 (90%) comparator-treated patients, the researchers noted, adding that cure rates in the intent-to-treat population at the TOC visit were about 81% in both groups.

The cure rates exceeded 90% among ceftobiprole-treated patients with abscess, cellulitis, or wound infections, and among patients who had surgical debridement of their infections performed within 48 hours after study enrollment, the authors reported, adding that these rates were comparable with those observed among comparator-treated patients.

Among patients with S. aureus, MRSA, and MSSA infections, cure rates at the TOC visit among ceftobiprole-treated patients and among comparator-treated patients were also comparable.

The difference in cure rates of complicated skin and skin-structure infections associated with bacteremia was not statistically significant.

Among the 30 ceftobiprole-treated individuals from whom P. aeruginosa was isolated at baseline, 26 (87%) were clinically cured, according to the researchers. Among the 12 ceftobiprole-treated patients from whom P. aeruginosa was isolated as the sole pathogen at baseline, 9 (75%) were determined to be clinically cured at the TOC visit.

In an accompanying editorial, Dr. Andreas F. Widmer concurred with the researchers and noted that for infections involving enterobacteriaceae, ceftobiprole may become the drug of choice if currently unknown adverse effects do not limit its use in the future (Clin. Infect. Dis. 2008;46:656–8).

MRSA coverage with ceftobiprole may improve outcomes in complicated skin and skin-structure infections by enabling early bactericidal therapy in patients admitted to emergency departments with infections not yet identified as being caused by MRSA, said Dr. Widmer of the division of infectious disease and hospital epidemiology at University Hospital in Basel, Switzerland.

"This promising new agent may be regarded as the first clinically effective cephalosporin against MRSA for treatment of complicated skin and skin-structure infections, with two randomized clinical trials supporting its efficacy," he said, referring to a trial published this year by the same group of investigators that compared ceftobiprole with vancomycin alone (Antimicrob. Agents Chemother. 2008;52:37–44).

Dr. Widmer has been a member of an expert group for Novartis and has served on the advisory board for Arpida Ltd.

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Monotherapy with ceftobiprole was found to be as effective as vancomycin plus ceftazidime for treating patients with a broad range of complicated skin and skin-structure infections caused by gram-positive and gram-negative bacteria.

Following the completion of successful phase III registration trials, the Food and Drug Administration granted ceftobiprole fast-track status for the treatment of both complicated skin and skin-structure infections caused by methicillin-resistant staphylococci and hospital-acquired pneumonia.

Ceftobiprole is a novel, broad-spectrum cephalosporin developed jointly by Basilea Pharmaceutica AG and Cilag AG International (a Johnson & Johnson company).

The randomized, double-blind, multicenter trial included 828 patients with diabetic foot infections, abscess, cellulitis, and wound infection, reported Gary J. Noel and his fellow researchers, all full-time employees of Johnson & Johnson Pharmaceutical Research and Development, Raritan, N.J., which funded the study (Clin. Infect. Dis. 2008;46:647–55).

Infecting pathogen types—identified in at least 10 patients at baseline—included coagulase-negative and coagulase-positive staphylococci, Pseudomonas aeruginosa, β-hemolytic streptococci, and enterobacteriaceae. The most prevalent pathogens were gram-positive bacteria, specifically methicillin-resistant Staphylococcus aureus (MRSA) (123 patients) and methicillin-susceptible S. aureus (MSSA) (250 patients).

The patient cohort, accumulated over 129 international sites, was divided into two arms, with 547 patients receiving ceftobiprole and 281 receiving the glycopeptide antibiotic vancomycin plus the third-generation cephalosporin ceftazidime, according to the researchers.

Patients in the ceftobiprole arm received 500 mg for 120 minutes every 8 hours, while in the comparator group, the starting dose was 1,000 mg vancomycin infused over 60 minutes every 12 hours plus 1,000 mg ceftazidime infused over 120 minutes every 8 hours.

The mean duration of treatment in the clinically evaluable population was about 9 days in both arms, the authors noted.

At the investigating physicians' discretion, empirical treatment with metronidazole (Flagyl, Pfizer) was permitted to provide activity against anaerobic bacteria. The nitroimidazole anti-infective was given to 39 of the ceftobiprole-treated patients and 17 of the comparator-treated patients, the researchers wrote.

At the test-of-cure (TOC) visit (after 6–17 days of treatment) for the evaluable patients, clinical cure occurred for 439 of 485 (91%) ceftobiprole-treated patients and for 220 of 244 (90%) comparator-treated patients, the researchers noted, adding that cure rates in the intent-to-treat population at the TOC visit were about 81% in both groups.

The cure rates exceeded 90% among ceftobiprole-treated patients with abscess, cellulitis, or wound infections, and among patients who had surgical debridement of their infections performed within 48 hours after study enrollment, the authors reported, adding that these rates were comparable with those observed among comparator-treated patients.

Among patients with S. aureus, MRSA, and MSSA infections, cure rates at the TOC visit among ceftobiprole-treated patients and among comparator-treated patients were also comparable.

The difference in cure rates of complicated skin and skin-structure infections associated with bacteremia was not statistically significant.

Among the 30 ceftobiprole-treated individuals from whom P. aeruginosa was isolated at baseline, 26 (87%) were clinically cured, according to the researchers. Among the 12 ceftobiprole-treated patients from whom P. aeruginosa was isolated as the sole pathogen at baseline, 9 (75%) were determined to be clinically cured at the TOC visit.

In an accompanying editorial, Dr. Andreas F. Widmer concurred with the researchers and noted that for infections involving enterobacteriaceae, ceftobiprole may become the drug of choice if currently unknown adverse effects do not limit its use in the future (Clin. Infect. Dis. 2008;46:656–8).

MRSA coverage with ceftobiprole may improve outcomes in complicated skin and skin-structure infections by enabling early bactericidal therapy in patients admitted to emergency departments with infections not yet identified as being caused by MRSA, said Dr. Widmer of the division of infectious disease and hospital epidemiology at University Hospital in Basel, Switzerland.

"This promising new agent may be regarded as the first clinically effective cephalosporin against MRSA for treatment of complicated skin and skin-structure infections, with two randomized clinical trials supporting its efficacy," he said, referring to a trial published this year by the same group of investigators that compared ceftobiprole with vancomycin alone (Antimicrob. Agents Chemother. 2008;52:37–44).

Dr. Widmer has been a member of an expert group for Novartis and has served on the advisory board for Arpida Ltd.

Monotherapy with ceftobiprole was found to be as effective as vancomycin plus ceftazidime for treating patients with a broad range of complicated skin and skin-structure infections caused by gram-positive and gram-negative bacteria.

Following the completion of successful phase III registration trials, the Food and Drug Administration granted ceftobiprole fast-track status for the treatment of both complicated skin and skin-structure infections caused by methicillin-resistant staphylococci and hospital-acquired pneumonia.

Ceftobiprole is a novel, broad-spectrum cephalosporin developed jointly by Basilea Pharmaceutica AG and Cilag AG International (a Johnson & Johnson company).

The randomized, double-blind, multicenter trial included 828 patients with diabetic foot infections, abscess, cellulitis, and wound infection, reported Gary J. Noel and his fellow researchers, all full-time employees of Johnson & Johnson Pharmaceutical Research and Development, Raritan, N.J., which funded the study (Clin. Infect. Dis. 2008;46:647–55).

Infecting pathogen types—identified in at least 10 patients at baseline—included coagulase-negative and coagulase-positive staphylococci, Pseudomonas aeruginosa, β-hemolytic streptococci, and enterobacteriaceae. The most prevalent pathogens were gram-positive bacteria, specifically methicillin-resistant Staphylococcus aureus (MRSA) (123 patients) and methicillin-susceptible S. aureus (MSSA) (250 patients).

The patient cohort, accumulated over 129 international sites, was divided into two arms, with 547 patients receiving ceftobiprole and 281 receiving the glycopeptide antibiotic vancomycin plus the third-generation cephalosporin ceftazidime, according to the researchers.

Patients in the ceftobiprole arm received 500 mg for 120 minutes every 8 hours, while in the comparator group, the starting dose was 1,000 mg vancomycin infused over 60 minutes every 12 hours plus 1,000 mg ceftazidime infused over 120 minutes every 8 hours.

The mean duration of treatment in the clinically evaluable population was about 9 days in both arms, the authors noted.

At the investigating physicians' discretion, empirical treatment with metronidazole (Flagyl, Pfizer) was permitted to provide activity against anaerobic bacteria. The nitroimidazole anti-infective was given to 39 of the ceftobiprole-treated patients and 17 of the comparator-treated patients, the researchers wrote.

At the test-of-cure (TOC) visit (after 6–17 days of treatment) for the evaluable patients, clinical cure occurred for 439 of 485 (91%) ceftobiprole-treated patients and for 220 of 244 (90%) comparator-treated patients, the researchers noted, adding that cure rates in the intent-to-treat population at the TOC visit were about 81% in both groups.

The cure rates exceeded 90% among ceftobiprole-treated patients with abscess, cellulitis, or wound infections, and among patients who had surgical debridement of their infections performed within 48 hours after study enrollment, the authors reported, adding that these rates were comparable with those observed among comparator-treated patients.

Among patients with S. aureus, MRSA, and MSSA infections, cure rates at the TOC visit among ceftobiprole-treated patients and among comparator-treated patients were also comparable.

The difference in cure rates of complicated skin and skin-structure infections associated with bacteremia was not statistically significant.

Among the 30 ceftobiprole-treated individuals from whom P. aeruginosa was isolated at baseline, 26 (87%) were clinically cured, according to the researchers. Among the 12 ceftobiprole-treated patients from whom P. aeruginosa was isolated as the sole pathogen at baseline, 9 (75%) were determined to be clinically cured at the TOC visit.

In an accompanying editorial, Dr. Andreas F. Widmer concurred with the researchers and noted that for infections involving enterobacteriaceae, ceftobiprole may become the drug of choice if currently unknown adverse effects do not limit its use in the future (Clin. Infect. Dis. 2008;46:656–8).

MRSA coverage with ceftobiprole may improve outcomes in complicated skin and skin-structure infections by enabling early bactericidal therapy in patients admitted to emergency departments with infections not yet identified as being caused by MRSA, said Dr. Widmer of the division of infectious disease and hospital epidemiology at University Hospital in Basel, Switzerland.

"This promising new agent may be regarded as the first clinically effective cephalosporin against MRSA for treatment of complicated skin and skin-structure infections, with two randomized clinical trials supporting its efficacy," he said, referring to a trial published this year by the same group of investigators that compared ceftobiprole with vancomycin alone (Antimicrob. Agents Chemother. 2008;52:37–44).

Dr. Widmer has been a member of an expert group for Novartis and has served on the advisory board for Arpida Ltd.

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Diarrhea May Resolve, but C. difficile Spores Remain

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Diarrhea May Resolve, but C. difficile Spores Remain

Patients with Clostridium difficile-associated disease frequently are contaminated on multiple skin sites that may remain a source of transmission even after the diarrhea has resolved.

In this study of 27 patients with C. difficile-associated disease, spores were transmitted to the gloved hand of an investigator after contact with various patient skin areas, including patients' hands and forearms, in addition to the groin, abdomen, and chest, said Dr. Curtis J. Donskey, director of infection control of the Veteran's Affairs Medical Center, Cleveland, and his associates.

"We've illustrated that C. difficile is widely distributed over the skin of patients and that health care workers should be wearing sterile gloves when touching these patients, even for such apparently minor contact as adjusting an intravenous catheter," Dr. Donskey said in an interview.

The 27 male patients had received a diagnosis of C. difficile-associated disease (CDAD) during the period from October 2006 to January 2007. Their ages ranged from 50 to 91 years (mean 68), and 12 were nursing home residents.

Patients' clinical conditions included diabetes mellitus (11), cancer (3), end-stage renal disease (3), previous CDAD (8), fecal incontinence (3), and dementia (4); several patients had multiple conditions. All patients had received antibiotics in the previous 3 months, the investigators said (Clin. Infect. Dis. 2008;46:447–50).

Within 3 days of the diagnosis of CDAD, skin cultures were obtained by applying premoistened, sterile rayon swabs to each patient's groin, abdomen, chest, and forearm. Culture specimens also were obtained from the surface of one of the patient's hands.

Of the 27 patients, 35% had spores on the hand, 20% on the forearm, 40% on the chest, 55% on the abdomen, and 60% on the groin.

To determine whether spores on skin could be transmitted to the hands of health care workers, an investigator donned sterile gloves and contacted the same skin sites of the final 10 subjects enrolled. After each skin contact, the gloved hand was imprinted onto appropriate agar plates. Contamination percentages were similar: hand and chest, 40%; forearm, 30%; abdomen, 50%; and groin, 70%.

All but two patients had contamination on more than one skin site, and the number of colonies acquired on gloves ranged from 1 to more than 100, Dr. Donskey and his associates said, adding that contact with the groin typically yielded the highest number of colonies.

A total of 17 patients with CDAD and confirmed C. difficile on the chest and/or abdomen had follow-up culture specimens taken on treatment days 5–14. Of those 39 culture specimens, 31 were collected after resolution of diarrhea, which occurred 3–7 days into treatment. The median time from resolution of diarrhea to detection of negative skin cultures was 7 days, and 10 of the 17 patients remained hospitalized and had culture specimens taken after 9–14 days of treatment. Of those, six had positive chest and/or abdominal culture results, although diarrhea had resolved in all of these patients by day 7, the investigators said.

"We may not be keeping these patients in isolation as long as we should. The current guidelines for C. difficile management suggest that you can take patients out of isolation once their diarrhea has resolved, but our paper implies that it may be reasonable to continue isolation beyond that point," Dr. Donskey told this news organization.

The authors concluded that the data outlined in their brief report confirm that the skin of CDAD-affected patients provides a major potential source of C. difficile transmission.

"Our findings reinforce the importance of wearing gloves when contacting the skin of CDAD-affected patients," said Dr. Donskey. "We observe that health care workers will use careful precautions when doing detailed exams on patients, or when examining their abdomen or groin, but they may be less likely to comply with the recommendations to wear gloves when touching patients' hands or arms, thus risking the spread of C. difficile."

This study was supported by a grant from the Department of Veterans Affairs Advanced Research Career Development Award.

Dr. Donskey has received research funding from Ortho-McNeil Inc., Merck & Co., ViroPharma Inc., Elan Pharmaceuticals Inc., and IPSAT (Intestinal Protection System in Antibiotic Treatment) Therapies Ltd., and is on the speakers bureaus of Elan and Ortho-McNeil.

Hand imprint cultures taken after contact with a CDADpatient's abdomen (left) and chest (right)reinforce the importance of wearing gloves when conducting exams. The Case Western Reserve University School of Medicine

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Patients with Clostridium difficile-associated disease frequently are contaminated on multiple skin sites that may remain a source of transmission even after the diarrhea has resolved.

In this study of 27 patients with C. difficile-associated disease, spores were transmitted to the gloved hand of an investigator after contact with various patient skin areas, including patients' hands and forearms, in addition to the groin, abdomen, and chest, said Dr. Curtis J. Donskey, director of infection control of the Veteran's Affairs Medical Center, Cleveland, and his associates.

"We've illustrated that C. difficile is widely distributed over the skin of patients and that health care workers should be wearing sterile gloves when touching these patients, even for such apparently minor contact as adjusting an intravenous catheter," Dr. Donskey said in an interview.

The 27 male patients had received a diagnosis of C. difficile-associated disease (CDAD) during the period from October 2006 to January 2007. Their ages ranged from 50 to 91 years (mean 68), and 12 were nursing home residents.

Patients' clinical conditions included diabetes mellitus (11), cancer (3), end-stage renal disease (3), previous CDAD (8), fecal incontinence (3), and dementia (4); several patients had multiple conditions. All patients had received antibiotics in the previous 3 months, the investigators said (Clin. Infect. Dis. 2008;46:447–50).

Within 3 days of the diagnosis of CDAD, skin cultures were obtained by applying premoistened, sterile rayon swabs to each patient's groin, abdomen, chest, and forearm. Culture specimens also were obtained from the surface of one of the patient's hands.

Of the 27 patients, 35% had spores on the hand, 20% on the forearm, 40% on the chest, 55% on the abdomen, and 60% on the groin.

To determine whether spores on skin could be transmitted to the hands of health care workers, an investigator donned sterile gloves and contacted the same skin sites of the final 10 subjects enrolled. After each skin contact, the gloved hand was imprinted onto appropriate agar plates. Contamination percentages were similar: hand and chest, 40%; forearm, 30%; abdomen, 50%; and groin, 70%.

All but two patients had contamination on more than one skin site, and the number of colonies acquired on gloves ranged from 1 to more than 100, Dr. Donskey and his associates said, adding that contact with the groin typically yielded the highest number of colonies.

A total of 17 patients with CDAD and confirmed C. difficile on the chest and/or abdomen had follow-up culture specimens taken on treatment days 5–14. Of those 39 culture specimens, 31 were collected after resolution of diarrhea, which occurred 3–7 days into treatment. The median time from resolution of diarrhea to detection of negative skin cultures was 7 days, and 10 of the 17 patients remained hospitalized and had culture specimens taken after 9–14 days of treatment. Of those, six had positive chest and/or abdominal culture results, although diarrhea had resolved in all of these patients by day 7, the investigators said.

"We may not be keeping these patients in isolation as long as we should. The current guidelines for C. difficile management suggest that you can take patients out of isolation once their diarrhea has resolved, but our paper implies that it may be reasonable to continue isolation beyond that point," Dr. Donskey told this news organization.

The authors concluded that the data outlined in their brief report confirm that the skin of CDAD-affected patients provides a major potential source of C. difficile transmission.

"Our findings reinforce the importance of wearing gloves when contacting the skin of CDAD-affected patients," said Dr. Donskey. "We observe that health care workers will use careful precautions when doing detailed exams on patients, or when examining their abdomen or groin, but they may be less likely to comply with the recommendations to wear gloves when touching patients' hands or arms, thus risking the spread of C. difficile."

This study was supported by a grant from the Department of Veterans Affairs Advanced Research Career Development Award.

Dr. Donskey has received research funding from Ortho-McNeil Inc., Merck & Co., ViroPharma Inc., Elan Pharmaceuticals Inc., and IPSAT (Intestinal Protection System in Antibiotic Treatment) Therapies Ltd., and is on the speakers bureaus of Elan and Ortho-McNeil.

Hand imprint cultures taken after contact with a CDADpatient's abdomen (left) and chest (right)reinforce the importance of wearing gloves when conducting exams. The Case Western Reserve University School of Medicine

Patients with Clostridium difficile-associated disease frequently are contaminated on multiple skin sites that may remain a source of transmission even after the diarrhea has resolved.

In this study of 27 patients with C. difficile-associated disease, spores were transmitted to the gloved hand of an investigator after contact with various patient skin areas, including patients' hands and forearms, in addition to the groin, abdomen, and chest, said Dr. Curtis J. Donskey, director of infection control of the Veteran's Affairs Medical Center, Cleveland, and his associates.

"We've illustrated that C. difficile is widely distributed over the skin of patients and that health care workers should be wearing sterile gloves when touching these patients, even for such apparently minor contact as adjusting an intravenous catheter," Dr. Donskey said in an interview.

The 27 male patients had received a diagnosis of C. difficile-associated disease (CDAD) during the period from October 2006 to January 2007. Their ages ranged from 50 to 91 years (mean 68), and 12 were nursing home residents.

Patients' clinical conditions included diabetes mellitus (11), cancer (3), end-stage renal disease (3), previous CDAD (8), fecal incontinence (3), and dementia (4); several patients had multiple conditions. All patients had received antibiotics in the previous 3 months, the investigators said (Clin. Infect. Dis. 2008;46:447–50).

Within 3 days of the diagnosis of CDAD, skin cultures were obtained by applying premoistened, sterile rayon swabs to each patient's groin, abdomen, chest, and forearm. Culture specimens also were obtained from the surface of one of the patient's hands.

Of the 27 patients, 35% had spores on the hand, 20% on the forearm, 40% on the chest, 55% on the abdomen, and 60% on the groin.

To determine whether spores on skin could be transmitted to the hands of health care workers, an investigator donned sterile gloves and contacted the same skin sites of the final 10 subjects enrolled. After each skin contact, the gloved hand was imprinted onto appropriate agar plates. Contamination percentages were similar: hand and chest, 40%; forearm, 30%; abdomen, 50%; and groin, 70%.

All but two patients had contamination on more than one skin site, and the number of colonies acquired on gloves ranged from 1 to more than 100, Dr. Donskey and his associates said, adding that contact with the groin typically yielded the highest number of colonies.

A total of 17 patients with CDAD and confirmed C. difficile on the chest and/or abdomen had follow-up culture specimens taken on treatment days 5–14. Of those 39 culture specimens, 31 were collected after resolution of diarrhea, which occurred 3–7 days into treatment. The median time from resolution of diarrhea to detection of negative skin cultures was 7 days, and 10 of the 17 patients remained hospitalized and had culture specimens taken after 9–14 days of treatment. Of those, six had positive chest and/or abdominal culture results, although diarrhea had resolved in all of these patients by day 7, the investigators said.

"We may not be keeping these patients in isolation as long as we should. The current guidelines for C. difficile management suggest that you can take patients out of isolation once their diarrhea has resolved, but our paper implies that it may be reasonable to continue isolation beyond that point," Dr. Donskey told this news organization.

The authors concluded that the data outlined in their brief report confirm that the skin of CDAD-affected patients provides a major potential source of C. difficile transmission.

"Our findings reinforce the importance of wearing gloves when contacting the skin of CDAD-affected patients," said Dr. Donskey. "We observe that health care workers will use careful precautions when doing detailed exams on patients, or when examining their abdomen or groin, but they may be less likely to comply with the recommendations to wear gloves when touching patients' hands or arms, thus risking the spread of C. difficile."

This study was supported by a grant from the Department of Veterans Affairs Advanced Research Career Development Award.

Dr. Donskey has received research funding from Ortho-McNeil Inc., Merck & Co., ViroPharma Inc., Elan Pharmaceuticals Inc., and IPSAT (Intestinal Protection System in Antibiotic Treatment) Therapies Ltd., and is on the speakers bureaus of Elan and Ortho-McNeil.

Hand imprint cultures taken after contact with a CDADpatient's abdomen (left) and chest (right)reinforce the importance of wearing gloves when conducting exams. The Case Western Reserve University School of Medicine

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Restricting Diet for Prevention Of Atopy Has Limited Worth

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Restricting Diet for Prevention Of Atopy Has Limited Worth

The documented benefits of nutritional intervention that might prevent or delay the onset of atopic disease are largely limited to infants at high risk of developing allergy because a parent or sibling has allergic disease, according to a revised policy statement of the American Academy of Pediatrics.

"Current evidence does not support a major role for maternal dietary restrictions during pregnancy or lactation," according to the new report. Therefore, physicians advising women on nutritional options related to allergies during pregnancy, lactation, and the first year of life can be less restrictive than they have been up to now.

"[Physicians] need to reconsider the entire issue of how they feed babies with the intention of preventing allergies," said Dr. Frank R. Greer, chairman of the American Academy of Pediatrics (AAP) Committee on Nutrition, which developed the statement in cooperation with the academy's Section on Allergy and Immunology.

The new document replaces a 2000 policy statement from the AAP that addressed the use of hypoallergenic infant formulas and included provisional recommendations for dietary management for the prevention of atopic disease (Pediatrics 2008;121:183–91).

"The idea that egg, fish, and foods containing peanut protein should not be introduced before 1 year of age is not based on good science," Dr. Greer said in an interview. "I suppose that if I had a baby with severe eczema, I would not recommend those foods, but the problem is these restrictions have been applied to all babies."

There is evidence that breast-feeding for at least 4 months, compared with feeding formula made with intact cow milk protein, prevents or delays the occurrence of atopic dermatitis, cow milk allergy, and wheezing in early childhood.

In studies of infants at high risk of atopy who are not exclusively breast-fed for 4–6 months or are formula fed, there is modest evidence that the onset of atopic dermatitis might be delayed or prevented in early childhood by the use of extensively or partially hydrolyzed formulas, compared with cow milk formula, they said. However, not all hydrolyzed formula might have the same effect, and more research is needed to determine if the benefits extend to later childhood and adolescence.

Dr. Greer and his colleagues also concluded that there is scant evidence that delaying the introduction of complementary foods beyond 4–6 months of age prevents atopic disease.

Other statements summarizing the current evidence included the following:

PIMaternal dietary restrictions during pregnancy do not appear to play a significant role in the prevention of atopic disease in infants.

PIThere is no convincing evidence for the use of soy-based infant formula for the purpose of allergy prevention.

PIFor infants beyond 4–6 months of age, there is insufficient data to support a protective effect of any dietary intervention for the development of atopic disease.

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The documented benefits of nutritional intervention that might prevent or delay the onset of atopic disease are largely limited to infants at high risk of developing allergy because a parent or sibling has allergic disease, according to a revised policy statement of the American Academy of Pediatrics.

"Current evidence does not support a major role for maternal dietary restrictions during pregnancy or lactation," according to the new report. Therefore, physicians advising women on nutritional options related to allergies during pregnancy, lactation, and the first year of life can be less restrictive than they have been up to now.

"[Physicians] need to reconsider the entire issue of how they feed babies with the intention of preventing allergies," said Dr. Frank R. Greer, chairman of the American Academy of Pediatrics (AAP) Committee on Nutrition, which developed the statement in cooperation with the academy's Section on Allergy and Immunology.

The new document replaces a 2000 policy statement from the AAP that addressed the use of hypoallergenic infant formulas and included provisional recommendations for dietary management for the prevention of atopic disease (Pediatrics 2008;121:183–91).

"The idea that egg, fish, and foods containing peanut protein should not be introduced before 1 year of age is not based on good science," Dr. Greer said in an interview. "I suppose that if I had a baby with severe eczema, I would not recommend those foods, but the problem is these restrictions have been applied to all babies."

There is evidence that breast-feeding for at least 4 months, compared with feeding formula made with intact cow milk protein, prevents or delays the occurrence of atopic dermatitis, cow milk allergy, and wheezing in early childhood.

In studies of infants at high risk of atopy who are not exclusively breast-fed for 4–6 months or are formula fed, there is modest evidence that the onset of atopic dermatitis might be delayed or prevented in early childhood by the use of extensively or partially hydrolyzed formulas, compared with cow milk formula, they said. However, not all hydrolyzed formula might have the same effect, and more research is needed to determine if the benefits extend to later childhood and adolescence.

Dr. Greer and his colleagues also concluded that there is scant evidence that delaying the introduction of complementary foods beyond 4–6 months of age prevents atopic disease.

Other statements summarizing the current evidence included the following:

PIMaternal dietary restrictions during pregnancy do not appear to play a significant role in the prevention of atopic disease in infants.

PIThere is no convincing evidence for the use of soy-based infant formula for the purpose of allergy prevention.

PIFor infants beyond 4–6 months of age, there is insufficient data to support a protective effect of any dietary intervention for the development of atopic disease.

The documented benefits of nutritional intervention that might prevent or delay the onset of atopic disease are largely limited to infants at high risk of developing allergy because a parent or sibling has allergic disease, according to a revised policy statement of the American Academy of Pediatrics.

"Current evidence does not support a major role for maternal dietary restrictions during pregnancy or lactation," according to the new report. Therefore, physicians advising women on nutritional options related to allergies during pregnancy, lactation, and the first year of life can be less restrictive than they have been up to now.

"[Physicians] need to reconsider the entire issue of how they feed babies with the intention of preventing allergies," said Dr. Frank R. Greer, chairman of the American Academy of Pediatrics (AAP) Committee on Nutrition, which developed the statement in cooperation with the academy's Section on Allergy and Immunology.

The new document replaces a 2000 policy statement from the AAP that addressed the use of hypoallergenic infant formulas and included provisional recommendations for dietary management for the prevention of atopic disease (Pediatrics 2008;121:183–91).

"The idea that egg, fish, and foods containing peanut protein should not be introduced before 1 year of age is not based on good science," Dr. Greer said in an interview. "I suppose that if I had a baby with severe eczema, I would not recommend those foods, but the problem is these restrictions have been applied to all babies."

There is evidence that breast-feeding for at least 4 months, compared with feeding formula made with intact cow milk protein, prevents or delays the occurrence of atopic dermatitis, cow milk allergy, and wheezing in early childhood.

In studies of infants at high risk of atopy who are not exclusively breast-fed for 4–6 months or are formula fed, there is modest evidence that the onset of atopic dermatitis might be delayed or prevented in early childhood by the use of extensively or partially hydrolyzed formulas, compared with cow milk formula, they said. However, not all hydrolyzed formula might have the same effect, and more research is needed to determine if the benefits extend to later childhood and adolescence.

Dr. Greer and his colleagues also concluded that there is scant evidence that delaying the introduction of complementary foods beyond 4–6 months of age prevents atopic disease.

Other statements summarizing the current evidence included the following:

PIMaternal dietary restrictions during pregnancy do not appear to play a significant role in the prevention of atopic disease in infants.

PIThere is no convincing evidence for the use of soy-based infant formula for the purpose of allergy prevention.

PIFor infants beyond 4–6 months of age, there is insufficient data to support a protective effect of any dietary intervention for the development of atopic disease.

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Restricting Diet for Prevention Of Atopy Has Limited Worth
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Preventive Practices Can Blunt Suture Needle Sticks

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Preventive Practices Can Blunt Suture Needle Sticks

CHICAGO — Most of the estimated 1,000 suture needle sticks endured by surgeons and surgical residents in the United States each day can be prevented by protecting the needle point within the needle driver, according to Dr. Joy Kunishige.

"Before the needle and needle driver are either handed off to the assistant or returned to the surgical tray, pivot the needle 90 degrees toward the instrument joint," said Dr. Kunishige, a dermatology resident at the University of Texas M.D. Anderson Cancer Center in Houston.

"Next, close the needle driver on the body near, but not on, the shank of the needle," she said. "The needle point should be directed toward and almost touching the driver, thereby disarming the needle point."

To avoid dulling the needle, do not grasp the point by the needle driver, Dr. Kunishige said during a poster presentation at the annual meeting of the American Society for Dermatologic Surgery.

"These precautions are especially important in Mohs surgery because you're using the same tray and the same instruments throughout the procedure," she said in an interview. "If your procedure involves three layers, you're going to use the instrument three times plus once more for reconstruction, so the sharps is being constantly moved around, potentially exposing several people to the risk of a needle stick."

A simple and inexpensive solution for disarming a needle that is being temporarily put aside is to use a brightly colored piece of foam, such as that available at arts and crafts stores. "We keep the foam piece in the upper right-hand corner of the field and just stick our needle into that," Dr. Kunishige said.

The worst mistake is to leave an exposed needle on a patient's chest where it can fall when the patient moves. "Placing a tray on a patient's chest can be a mine field," she said.

Even when a needle stick does not cause infection, follow-up testing can cost up to $3,000, she added.

"If you make these little precautions habitual, you'll greatly reduce the risk of needle sticks in your workplace," Dr. Kunishige concluded.

The needle should be grasped in the needle driver as shown in the image above to avoid exposing the point. Courtesy Dr. Joy Kunishige

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CHICAGO — Most of the estimated 1,000 suture needle sticks endured by surgeons and surgical residents in the United States each day can be prevented by protecting the needle point within the needle driver, according to Dr. Joy Kunishige.

"Before the needle and needle driver are either handed off to the assistant or returned to the surgical tray, pivot the needle 90 degrees toward the instrument joint," said Dr. Kunishige, a dermatology resident at the University of Texas M.D. Anderson Cancer Center in Houston.

"Next, close the needle driver on the body near, but not on, the shank of the needle," she said. "The needle point should be directed toward and almost touching the driver, thereby disarming the needle point."

To avoid dulling the needle, do not grasp the point by the needle driver, Dr. Kunishige said during a poster presentation at the annual meeting of the American Society for Dermatologic Surgery.

"These precautions are especially important in Mohs surgery because you're using the same tray and the same instruments throughout the procedure," she said in an interview. "If your procedure involves three layers, you're going to use the instrument three times plus once more for reconstruction, so the sharps is being constantly moved around, potentially exposing several people to the risk of a needle stick."

A simple and inexpensive solution for disarming a needle that is being temporarily put aside is to use a brightly colored piece of foam, such as that available at arts and crafts stores. "We keep the foam piece in the upper right-hand corner of the field and just stick our needle into that," Dr. Kunishige said.

The worst mistake is to leave an exposed needle on a patient's chest where it can fall when the patient moves. "Placing a tray on a patient's chest can be a mine field," she said.

Even when a needle stick does not cause infection, follow-up testing can cost up to $3,000, she added.

"If you make these little precautions habitual, you'll greatly reduce the risk of needle sticks in your workplace," Dr. Kunishige concluded.

The needle should be grasped in the needle driver as shown in the image above to avoid exposing the point. Courtesy Dr. Joy Kunishige

CHICAGO — Most of the estimated 1,000 suture needle sticks endured by surgeons and surgical residents in the United States each day can be prevented by protecting the needle point within the needle driver, according to Dr. Joy Kunishige.

"Before the needle and needle driver are either handed off to the assistant or returned to the surgical tray, pivot the needle 90 degrees toward the instrument joint," said Dr. Kunishige, a dermatology resident at the University of Texas M.D. Anderson Cancer Center in Houston.

"Next, close the needle driver on the body near, but not on, the shank of the needle," she said. "The needle point should be directed toward and almost touching the driver, thereby disarming the needle point."

To avoid dulling the needle, do not grasp the point by the needle driver, Dr. Kunishige said during a poster presentation at the annual meeting of the American Society for Dermatologic Surgery.

"These precautions are especially important in Mohs surgery because you're using the same tray and the same instruments throughout the procedure," she said in an interview. "If your procedure involves three layers, you're going to use the instrument three times plus once more for reconstruction, so the sharps is being constantly moved around, potentially exposing several people to the risk of a needle stick."

A simple and inexpensive solution for disarming a needle that is being temporarily put aside is to use a brightly colored piece of foam, such as that available at arts and crafts stores. "We keep the foam piece in the upper right-hand corner of the field and just stick our needle into that," Dr. Kunishige said.

The worst mistake is to leave an exposed needle on a patient's chest where it can fall when the patient moves. "Placing a tray on a patient's chest can be a mine field," she said.

Even when a needle stick does not cause infection, follow-up testing can cost up to $3,000, she added.

"If you make these little precautions habitual, you'll greatly reduce the risk of needle sticks in your workplace," Dr. Kunishige concluded.

The needle should be grasped in the needle driver as shown in the image above to avoid exposing the point. Courtesy Dr. Joy Kunishige

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