Mark S. Lesney

CHICAGO — Clinical symptoms are critical when distinguishing between uninfected and mildly infected diabetic foot lesions, Warren S. Joseph, D.P.M., reported at the Vascular Annual Meeting.

For instance, lack of cellulitis indicates lack of infection, as does good granulation. If the foot wound is purulent, it is infected.

Surprisingly, culturing the wound for microorganisms is not the best way to diagnose infection. This is because even noninfected diabetic foot lesions are “wound toilets” or, less bluntly, they have a significant “bioburden or bioload” of microorganisms that are simply colonizing the lesion, said Dr. Joseph of the Veterans Affairs Medical Center in Coatesville, Pa.

And, just because an ulcer is colonized does not mean it is infected, he explained.

However, in patients whose diabetic foot lesions are colonized but not infected, physicians may feel uncomfortable about not doing anything, Dr. Joseph said.

Physicians know that the microbes are there, and they feel compelled to provide treatment.

In a situation such as this, topical treatments such as those with broad-spectrum activated silver are better than systemic antibiotics.

“Antibiotics do not heal wounds; antibiotics treat infection,” Dr. Joseph said, adding that he could not overemphasize the point that systemic antibiotics do not have a place in treating noninfected wounds.

Why? Because the first strain of vancomycin-resistant Staphylococcus aureus was found in a diabetic foot wound, and it showed up in a swab culture of a clinically noninfected wound.

According to Dr. Joseph, the Infectious Diseases Society of America's classification system developed last year defines mild infection as that extending less than 2 cm (www.idsociety.org

Moderate infection is greater than 2 cm and/or shows spread, streaking, or gangrene, but is still localized to the foot. Severe infections are systemic and life-threatening.

It is a misconception, Dr. Joseph pointed out, that all diabetic foot infections are polymicrobial.

Virtually all diabetic foot infections have been shown to be caused by just two microorganism types—Staphylococcus aureus and group B streptococci.

“This is great news, because when you think about what antibiotics you need for staph and strep—just about anything,” he said.

“Those broad-spectrum drugs we have been using all these years we probably do not need, with one small caveat—there has been an incredible increase in prevalence of methicillin-resistant staph in [the] diabetic foot.”

The bottom line is that 40% or more of all diabetic foot staph infections are methicillin resistant.

The number of diabetic foot patients who presented with methicillin-resistant Staphylococcus aureus doubled between 1999 and 2002, he said.

Given the wide variety of alternatives available—anything you would use for staph or strep throat—Dr. Joseph emphasized: “Do not use ciprofloxacin in the infected diabetic foot.” It has poor activity against staph and strep, and it is a single-step mutation to getting staph or strep resistant to ciprofloxacin.

“You might have a nice big S sitting next to the cipro line, but give that patient the drug, [and] within a week it's going to turn to an R,” Dr. Joseph said.

He also said that he ultimately believes it will be shown that severe infections will respond to antibiotics directed against staph and strep, even if there are corresponding anaerobic microbes present.

As an example of this, he used the analogy of a snake: Remove the head (staph and strep), and the rest dies.

However, he stated that the clinical data are not there just yet to support advising against the use of broad-spectrum antibiotics for such infections, and so he could not recommend it.

Dr. Joseph disclosed financial relationships with Merck and Pfizer.

CHICAGO — Clinical symptoms are critical when distinguishing between uninfected and mildly infected diabetic foot lesions, Warren S. Joseph, D.P.M., reported at the Vascular Annual Meeting.

For instance, lack of cellulitis indicates lack of infection, as does good granulation. If the foot wound is purulent, it is infected.

Surprisingly, culturing the wound for microorganisms is not the best way to diagnose infection. This is because even noninfected diabetic foot lesions are “wound toilets” or, less bluntly, they have a significant “bioburden or bioload” of microorganisms that are simply colonizing the lesion, said Dr. Joseph of the Veterans Affairs Medical Center in Coatesville, Pa.

And, just because an ulcer is colonized does not mean it is infected, he explained.

However, in patients whose diabetic foot lesions are colonized but not infected, physicians may feel uncomfortable about not doing anything, Dr. Joseph said.

Physicians know that the microbes are there, and they feel compelled to provide treatment.

In a situation such as this, topical treatments such as those with broad-spectrum activated silver are better than systemic antibiotics.

“Antibiotics do not heal wounds; antibiotics treat infection,” Dr. Joseph said, adding that he could not overemphasize the point that systemic antibiotics do not have a place in treating noninfected wounds.

Why? Because the first strain of vancomycin-resistant Staphylococcus aureus was found in a diabetic foot wound, and it showed up in a swab culture of a clinically noninfected wound.

According to Dr. Joseph, the Infectious Diseases Society of America's classification system developed last year defines mild infection as that extending less than 2 cm (www.idsociety.org

Moderate infection is greater than 2 cm and/or shows spread, streaking, or gangrene, but is still localized to the foot. Severe infections are systemic and life-threatening.

It is a misconception, Dr. Joseph pointed out, that all diabetic foot infections are polymicrobial.

Virtually all diabetic foot infections have been shown to be caused by just two microorganism types—Staphylococcus aureus and group B streptococci.

“This is great news, because when you think about what antibiotics you need for staph and strep—just about anything,” he said.

“Those broad-spectrum drugs we have been using all these years we probably do not need, with one small caveat—there has been an incredible increase in prevalence of methicillin-resistant staph in [the] diabetic foot.”

The bottom line is that 40% or more of all diabetic foot staph infections are methicillin resistant.

The number of diabetic foot patients who presented with methicillin-resistant Staphylococcus aureus doubled between 1999 and 2002, he said.

Given the wide variety of alternatives available—anything you would use for staph or strep throat—Dr. Joseph emphasized: “Do not use ciprofloxacin in the infected diabetic foot.” It has poor activity against staph and strep, and it is a single-step mutation to getting staph or strep resistant to ciprofloxacin.

“You might have a nice big S sitting next to the cipro line, but give that patient the drug, [and] within a week it's going to turn to an R,” Dr. Joseph said.

He also said that he ultimately believes it will be shown that severe infections will respond to antibiotics directed against staph and strep, even if there are corresponding anaerobic microbes present.

As an example of this, he used the analogy of a snake: Remove the head (staph and strep), and the rest dies.

However, he stated that the clinical data are not there just yet to support advising against the use of broad-spectrum antibiotics for such infections, and so he could not recommend it.

Dr. Joseph disclosed financial relationships with Merck and Pfizer.

CHICAGO — Clinical symptoms are critical when distinguishing between uninfected and mildly infected diabetic foot lesions, Warren S. Joseph, D.P.M., reported at the Vascular Annual Meeting.

For instance, lack of cellulitis indicates lack of infection, as does good granulation. If the foot wound is purulent, it is infected.

Surprisingly, culturing the wound for microorganisms is not the best way to diagnose infection. This is because even noninfected diabetic foot lesions are “wound toilets” or, less bluntly, they have a significant “bioburden or bioload” of microorganisms that are simply colonizing the lesion, said Dr. Joseph of the Veterans Affairs Medical Center in Coatesville, Pa.

And, just because an ulcer is colonized does not mean it is infected, he explained.

However, in patients whose diabetic foot lesions are colonized but not infected, physicians may feel uncomfortable about not doing anything, Dr. Joseph said.

Physicians know that the microbes are there, and they feel compelled to provide treatment.

In a situation such as this, topical treatments such as those with broad-spectrum activated silver are better than systemic antibiotics.

“Antibiotics do not heal wounds; antibiotics treat infection,” Dr. Joseph said, adding that he could not overemphasize the point that systemic antibiotics do not have a place in treating noninfected wounds.

Why? Because the first strain of vancomycin-resistant Staphylococcus aureus was found in a diabetic foot wound, and it showed up in a swab culture of a clinically noninfected wound.

According to Dr. Joseph, the Infectious Diseases Society of America's classification system developed last year defines mild infection as that extending less than 2 cm (www.idsociety.org

Moderate infection is greater than 2 cm and/or shows spread, streaking, or gangrene, but is still localized to the foot. Severe infections are systemic and life-threatening.

It is a misconception, Dr. Joseph pointed out, that all diabetic foot infections are polymicrobial.

Virtually all diabetic foot infections have been shown to be caused by just two microorganism types—Staphylococcus aureus and group B streptococci.

“This is great news, because when you think about what antibiotics you need for staph and strep—just about anything,” he said.

“Those broad-spectrum drugs we have been using all these years we probably do not need, with one small caveat—there has been an incredible increase in prevalence of methicillin-resistant staph in [the] diabetic foot.”

The bottom line is that 40% or more of all diabetic foot staph infections are methicillin resistant.

The number of diabetic foot patients who presented with methicillin-resistant Staphylococcus aureus doubled between 1999 and 2002, he said.

Given the wide variety of alternatives available—anything you would use for staph or strep throat—Dr. Joseph emphasized: “Do not use ciprofloxacin in the infected diabetic foot.” It has poor activity against staph and strep, and it is a single-step mutation to getting staph or strep resistant to ciprofloxacin.

“You might have a nice big S sitting next to the cipro line, but give that patient the drug, [and] within a week it's going to turn to an R,” Dr. Joseph said.

He also said that he ultimately believes it will be shown that severe infections will respond to antibiotics directed against staph and strep, even if there are corresponding anaerobic microbes present.

As an example of this, he used the analogy of a snake: Remove the head (staph and strep), and the rest dies.

However, he stated that the clinical data are not there just yet to support advising against the use of broad-spectrum antibiotics for such infections, and so he could not recommend it.

Dr. Joseph disclosed financial relationships with Merck and Pfizer.

The Food and Drug administration approved the first inhaled therapy for pulmonary arterial hypertension.

Iloprost, a stable synthetic analogue of prostacyclin, causes selective pulmonary vasodilation, improving exercise capacity and hemodynamics in patients with PAH.

The drug is a strong vasodilator and inhibitor of platelet aggregation. The inhalation formulation (Ventavis Inhalant Solution) was developed to replace continuous infusion prostacyclin, which was the first therapy shown to reduce mortality in a controlled study of patients with severe pulmonary hypertension. In nature, prostacyclin is a local hormone; intravenous introduction can result in systemic side effects and progressive tolerance, requiring more and more of the drug.

The randomized clinical trial reported for approval was conducted on 203 adult patients with PAH; 101 received inhaled iloprost, and 102 received placebo. The response rate in the iloprost group (6–9 inhalations per day) was 19%, compared with 4% for the placebo group. The response rate was determined using a primary composite end point that incorporated improvement in exercise capacity, improvement in at least one New York Heart Association PAH class, and no death or deterioration. Adverse responses with iloprost included flushing, cough, jaw pain, and headache.

Iloprost is dispensed in single-use glass ampules (2 mL) containing 20 mcg iloprost for inhalation via the Prodose Adaptive Aerosol Delivery system. Labeling indicated that iloprost should not be inhaled more than once every 2 hours, and the drug is not effective while a patient is sleeping. Vital signs should be monitored when initiating iloprost because of the risk of syncope.

Iloprost, though not yet commercially available in the United States, will be marketed by CoTherix Inc. as the Ventavis Inhalant Solution under exclusive contract with Schering AG, which markets the drug in Europe and Australia.

CoTherix had previously received orphan drug designation for iloprost from the FDA, in August 2004.

Iloprost is also undergoing continuing clinical trials in the United States to examine its interaction with other drug treatments for PAH, as well as for its potential as a preventive agent for lung cancer in heavy smokers.

The Food and Drug administration approved the first inhaled therapy for pulmonary arterial hypertension.

Iloprost, a stable synthetic analogue of prostacyclin, causes selective pulmonary vasodilation, improving exercise capacity and hemodynamics in patients with PAH.

The drug is a strong vasodilator and inhibitor of platelet aggregation. The inhalation formulation (Ventavis Inhalant Solution) was developed to replace continuous infusion prostacyclin, which was the first therapy shown to reduce mortality in a controlled study of patients with severe pulmonary hypertension. In nature, prostacyclin is a local hormone; intravenous introduction can result in systemic side effects and progressive tolerance, requiring more and more of the drug.

The randomized clinical trial reported for approval was conducted on 203 adult patients with PAH; 101 received inhaled iloprost, and 102 received placebo. The response rate in the iloprost group (6–9 inhalations per day) was 19%, compared with 4% for the placebo group. The response rate was determined using a primary composite end point that incorporated improvement in exercise capacity, improvement in at least one New York Heart Association PAH class, and no death or deterioration. Adverse responses with iloprost included flushing, cough, jaw pain, and headache.

Iloprost is dispensed in single-use glass ampules (2 mL) containing 20 mcg iloprost for inhalation via the Prodose Adaptive Aerosol Delivery system. Labeling indicated that iloprost should not be inhaled more than once every 2 hours, and the drug is not effective while a patient is sleeping. Vital signs should be monitored when initiating iloprost because of the risk of syncope.

Iloprost, though not yet commercially available in the United States, will be marketed by CoTherix Inc. as the Ventavis Inhalant Solution under exclusive contract with Schering AG, which markets the drug in Europe and Australia.

CoTherix had previously received orphan drug designation for iloprost from the FDA, in August 2004.

Iloprost is also undergoing continuing clinical trials in the United States to examine its interaction with other drug treatments for PAH, as well as for its potential as a preventive agent for lung cancer in heavy smokers.

The Food and Drug administration approved the first inhaled therapy for pulmonary arterial hypertension.

Iloprost, a stable synthetic analogue of prostacyclin, causes selective pulmonary vasodilation, improving exercise capacity and hemodynamics in patients with PAH.

The drug is a strong vasodilator and inhibitor of platelet aggregation. The inhalation formulation (Ventavis Inhalant Solution) was developed to replace continuous infusion prostacyclin, which was the first therapy shown to reduce mortality in a controlled study of patients with severe pulmonary hypertension. In nature, prostacyclin is a local hormone; intravenous introduction can result in systemic side effects and progressive tolerance, requiring more and more of the drug.

The randomized clinical trial reported for approval was conducted on 203 adult patients with PAH; 101 received inhaled iloprost, and 102 received placebo. The response rate in the iloprost group (6–9 inhalations per day) was 19%, compared with 4% for the placebo group. The response rate was determined using a primary composite end point that incorporated improvement in exercise capacity, improvement in at least one New York Heart Association PAH class, and no death or deterioration. Adverse responses with iloprost included flushing, cough, jaw pain, and headache.

Iloprost is dispensed in single-use glass ampules (2 mL) containing 20 mcg iloprost for inhalation via the Prodose Adaptive Aerosol Delivery system. Labeling indicated that iloprost should not be inhaled more than once every 2 hours, and the drug is not effective while a patient is sleeping. Vital signs should be monitored when initiating iloprost because of the risk of syncope.

Iloprost, though not yet commercially available in the United States, will be marketed by CoTherix Inc. as the Ventavis Inhalant Solution under exclusive contract with Schering AG, which markets the drug in Europe and Australia.

CoTherix had previously received orphan drug designation for iloprost from the FDA, in August 2004.

Iloprost is also undergoing continuing clinical trials in the United States to examine its interaction with other drug treatments for PAH, as well as for its potential as a preventive agent for lung cancer in heavy smokers.

SAN FRANCISCO — Between 20% and 30% of patients given preoperative induction therapy for cancer of the esophagus show a complete pathologic response. The remaining patients have a median survival time of 12–24 months and are subject to treatment known to considerably lower quality of life, according to paired presentations debating the value of induction therapy at the annual meeting of the American Association for Thoracic Surgery.

Despite anecdotal fears that preoperative chemoradiation increases operative mortality and morbidity, a metaanalysis of six published randomized clinical trials showed an improved 3-year survival rate and reduced locoregional tumor recurrence, compared with surgery alone. The mortality for preoperative chemoradiation therapy was 1.2%, compared with an overall complete pathologic response rate of 21%, according to Mark B. Orringer, M.D., director of the thoracic oncology program at the University of Michigan Medical Center, Ann Arbor.

Dr. Orringer saw additional “secondary benefits” of neoadjuvant chemoradiation therapy, including easier to enforce abstention from alcohol and smoking, and a weight loss of 20–30 pounds before surgery in patients who had a tendency to be markedly obese as a class.

In contrast, citing the same metaanalysis, Gail Darling, M.D., a researcher at Toronto General Hospital, indicated there was no significant improvement in survival at 1 or 2 years and that the 3-year results “are heavily influenced by the single positive trial report” of the six randomized trials studied.

In a disease that is rarely cured, quality of life is an important outcome measure, according to Dr. Darling, and at least 70%–75% of patients treated with induction chemoradiation will not be cured.

“Such patients might have preferred improved quality of life with immediate esophagectomy resulting in the ability to eat until the end of their days, spending the remaining months with family or friends,” she said.

While disagreeing on whether preoperative induction therapy should become the standard of care, both Dr. Orringer and Dr. Darling agreed on the critical requirement for stage-specific decision making.

“Most patients with resectable stage II and III esophageal carcinomas should be offered this treatment,” Dr. Orringer said. Esophagectomy alone is the best course in those with stage I tumors, other contraindicating medical problems, or age greater than 75 years, he noted.

Similarly, citing 5-year survival rates of 76% in stage I patients and 90% in stage 0 patients receiving surgery alone, Dr. Darling concluded, “Such patients do not derive benefit from induction therapy. Stage-specific therapy should be developed as it has for most other cancers.”

SAN FRANCISCO — Between 20% and 30% of patients given preoperative induction therapy for cancer of the esophagus show a complete pathologic response. The remaining patients have a median survival time of 12–24 months and are subject to treatment known to considerably lower quality of life, according to paired presentations debating the value of induction therapy at the annual meeting of the American Association for Thoracic Surgery.

Despite anecdotal fears that preoperative chemoradiation increases operative mortality and morbidity, a metaanalysis of six published randomized clinical trials showed an improved 3-year survival rate and reduced locoregional tumor recurrence, compared with surgery alone. The mortality for preoperative chemoradiation therapy was 1.2%, compared with an overall complete pathologic response rate of 21%, according to Mark B. Orringer, M.D., director of the thoracic oncology program at the University of Michigan Medical Center, Ann Arbor.

Dr. Orringer saw additional “secondary benefits” of neoadjuvant chemoradiation therapy, including easier to enforce abstention from alcohol and smoking, and a weight loss of 20–30 pounds before surgery in patients who had a tendency to be markedly obese as a class.

In contrast, citing the same metaanalysis, Gail Darling, M.D., a researcher at Toronto General Hospital, indicated there was no significant improvement in survival at 1 or 2 years and that the 3-year results “are heavily influenced by the single positive trial report” of the six randomized trials studied.

In a disease that is rarely cured, quality of life is an important outcome measure, according to Dr. Darling, and at least 70%–75% of patients treated with induction chemoradiation will not be cured.

“Such patients might have preferred improved quality of life with immediate esophagectomy resulting in the ability to eat until the end of their days, spending the remaining months with family or friends,” she said.

While disagreeing on whether preoperative induction therapy should become the standard of care, both Dr. Orringer and Dr. Darling agreed on the critical requirement for stage-specific decision making.

“Most patients with resectable stage II and III esophageal carcinomas should be offered this treatment,” Dr. Orringer said. Esophagectomy alone is the best course in those with stage I tumors, other contraindicating medical problems, or age greater than 75 years, he noted.

Similarly, citing 5-year survival rates of 76% in stage I patients and 90% in stage 0 patients receiving surgery alone, Dr. Darling concluded, “Such patients do not derive benefit from induction therapy. Stage-specific therapy should be developed as it has for most other cancers.”

SAN FRANCISCO — Between 20% and 30% of patients given preoperative induction therapy for cancer of the esophagus show a complete pathologic response. The remaining patients have a median survival time of 12–24 months and are subject to treatment known to considerably lower quality of life, according to paired presentations debating the value of induction therapy at the annual meeting of the American Association for Thoracic Surgery.

Despite anecdotal fears that preoperative chemoradiation increases operative mortality and morbidity, a metaanalysis of six published randomized clinical trials showed an improved 3-year survival rate and reduced locoregional tumor recurrence, compared with surgery alone. The mortality for preoperative chemoradiation therapy was 1.2%, compared with an overall complete pathologic response rate of 21%, according to Mark B. Orringer, M.D., director of the thoracic oncology program at the University of Michigan Medical Center, Ann Arbor.

Dr. Orringer saw additional “secondary benefits” of neoadjuvant chemoradiation therapy, including easier to enforce abstention from alcohol and smoking, and a weight loss of 20–30 pounds before surgery in patients who had a tendency to be markedly obese as a class.

In contrast, citing the same metaanalysis, Gail Darling, M.D., a researcher at Toronto General Hospital, indicated there was no significant improvement in survival at 1 or 2 years and that the 3-year results “are heavily influenced by the single positive trial report” of the six randomized trials studied.

In a disease that is rarely cured, quality of life is an important outcome measure, according to Dr. Darling, and at least 70%–75% of patients treated with induction chemoradiation will not be cured.

“Such patients might have preferred improved quality of life with immediate esophagectomy resulting in the ability to eat until the end of their days, spending the remaining months with family or friends,” she said.

While disagreeing on whether preoperative induction therapy should become the standard of care, both Dr. Orringer and Dr. Darling agreed on the critical requirement for stage-specific decision making.

“Most patients with resectable stage II and III esophageal carcinomas should be offered this treatment,” Dr. Orringer said. Esophagectomy alone is the best course in those with stage I tumors, other contraindicating medical problems, or age greater than 75 years, he noted.

Similarly, citing 5-year survival rates of 76% in stage I patients and 90% in stage 0 patients receiving surgery alone, Dr. Darling concluded, “Such patients do not derive benefit from induction therapy. Stage-specific therapy should be developed as it has for most other cancers.”

The peak age of acquisition of primary human herpesvirus 6 infection is between 9 and 21 months, according to results of a population-based study of 277 children followed from birth to 2 years.

Of the 277, 130 (47%) of the children were infected by the age of 24 months (N. Engl. J. Med. 2005;352:768–76). Human herpesvirus 6 (HHV-6) acquisition was associated with female sex (adjusted hazard ratio of 1.7) and having older siblings (adjusted hazard ratio of 2.1). Of the 227 children, 46% were female, and 52% had at least one sibling, said Danielle M. Zerr, M.D., of the department of pediatrics, University of Washington, Seattle, and her colleagues.

HHV-6 infection was monitored using polymerase chain reaction on saliva samples obtained weekly by parents using precut filter-paper strips. Serological detection of anti-HHV-6 antibodies was performed whenever a blood sample was taken from the child for other purposes.

Of the 81 children with a well-defined time of HHV-6 acquisition, 93% showed symptoms, most commonly fussiness (69%), rhinorrhea (65%), and fever (57%), with less-frequent occurrences of cough (33%), rash (31%), and diarrhea (26%).

Roseola, a clinical syndrome considered relatively specific for HHV-6, occurred in only 23% of the 81 children.

No seizures were reported. This was “in contrast to emergency department-based studies, in which seizures occurred in as many as 13% of children with primary HHV-6 infection,” they wrote.

Previous serologic studies have shown that HHV-6 infects 90% of children by 2 years of age, and it has been estimated that 20% of emergency department visits for fever are due to primary HHV-6 infection.

The peak age of acquisition of primary human herpesvirus 6 infection is between 9 and 21 months, according to results of a population-based study of 277 children followed from birth to 2 years.

Of the 277, 130 (47%) of the children were infected by the age of 24 months (N. Engl. J. Med. 2005;352:768–76). Human herpesvirus 6 (HHV-6) acquisition was associated with female sex (adjusted hazard ratio of 1.7) and having older siblings (adjusted hazard ratio of 2.1). Of the 227 children, 46% were female, and 52% had at least one sibling, said Danielle M. Zerr, M.D., of the department of pediatrics, University of Washington, Seattle, and her colleagues.

HHV-6 infection was monitored using polymerase chain reaction on saliva samples obtained weekly by parents using precut filter-paper strips. Serological detection of anti-HHV-6 antibodies was performed whenever a blood sample was taken from the child for other purposes.

Of the 81 children with a well-defined time of HHV-6 acquisition, 93% showed symptoms, most commonly fussiness (69%), rhinorrhea (65%), and fever (57%), with less-frequent occurrences of cough (33%), rash (31%), and diarrhea (26%).

Roseola, a clinical syndrome considered relatively specific for HHV-6, occurred in only 23% of the 81 children.

No seizures were reported. This was “in contrast to emergency department-based studies, in which seizures occurred in as many as 13% of children with primary HHV-6 infection,” they wrote.

Previous serologic studies have shown that HHV-6 infects 90% of children by 2 years of age, and it has been estimated that 20% of emergency department visits for fever are due to primary HHV-6 infection.

The peak age of acquisition of primary human herpesvirus 6 infection is between 9 and 21 months, according to results of a population-based study of 277 children followed from birth to 2 years.

Of the 277, 130 (47%) of the children were infected by the age of 24 months (N. Engl. J. Med. 2005;352:768–76). Human herpesvirus 6 (HHV-6) acquisition was associated with female sex (adjusted hazard ratio of 1.7) and having older siblings (adjusted hazard ratio of 2.1). Of the 227 children, 46% were female, and 52% had at least one sibling, said Danielle M. Zerr, M.D., of the department of pediatrics, University of Washington, Seattle, and her colleagues.

HHV-6 infection was monitored using polymerase chain reaction on saliva samples obtained weekly by parents using precut filter-paper strips. Serological detection of anti-HHV-6 antibodies was performed whenever a blood sample was taken from the child for other purposes.

Of the 81 children with a well-defined time of HHV-6 acquisition, 93% showed symptoms, most commonly fussiness (69%), rhinorrhea (65%), and fever (57%), with less-frequent occurrences of cough (33%), rash (31%), and diarrhea (26%).

Roseola, a clinical syndrome considered relatively specific for HHV-6, occurred in only 23% of the 81 children.

No seizures were reported. This was “in contrast to emergency department-based studies, in which seizures occurred in as many as 13% of children with primary HHV-6 infection,” they wrote.

Previous serologic studies have shown that HHV-6 infects 90% of children by 2 years of age, and it has been estimated that 20% of emergency department visits for fever are due to primary HHV-6 infection.

The peak age of acquisition of primary human herpesvirus 6 infection is between 9 and 21 months, according to results of a population-based study of 277 children followed from birth to 2 years.

Of the 277, 130 (47%) of the children were infected by the age of 24 months (N.Engl. J. Med. 2005;352:768–76).

Human herpesvirus 6 (HHV-6) acquisition was associated with female sex (adjusted hazard ratio of 1.7 and having older siblings (adjusted hazard ratio of 2.1). Of the 227 children, 46% were female, and 52% had at least one sibling, said Danielle M. Zerr, M.D., of the department of pediatrics, the University of Washington, Seattle, and her colleagues.

HHV-6 infection was monitored using polymerase chain reaction on saliva samples obtained weekly by parents using precut filter-paper strips. Serological detection of anti-HHV-6 antibodies was performed whenever a blood sample was taken from the child for other purposes.

Of the 81 children with a well-defined time of HHV-6 acquisition, 93% showed symptoms, most commonly fussiness (69%), rhinorrhea (65%), and fever (57%), with less-frequent occurrences of cough (33%), rash (31%), and diarrhea (26%).

Roseola, a clinical syndrome considered relatively specific for HHV-6, occurred in only 23% of the 81 children. No seizures were reported. This was “in contrast to emergency department-based studies, in which seizures occurred in as many as 13% of children with primary HHV-6 infection,” they wrote.

Previous serologic studies have shown that HHV-6 infects 90% of children by 2 years of age, and it has been estimated that 20% of emergency department visits for fever are due to primary HHV-6 infection.

The peak age of acquisition of primary human herpesvirus 6 infection is between 9 and 21 months, according to results of a population-based study of 277 children followed from birth to 2 years.

Of the 277, 130 (47%) of the children were infected by the age of 24 months (N.Engl. J. Med. 2005;352:768–76).

Human herpesvirus 6 (HHV-6) acquisition was associated with female sex (adjusted hazard ratio of 1.7 and having older siblings (adjusted hazard ratio of 2.1). Of the 227 children, 46% were female, and 52% had at least one sibling, said Danielle M. Zerr, M.D., of the department of pediatrics, the University of Washington, Seattle, and her colleagues.

HHV-6 infection was monitored using polymerase chain reaction on saliva samples obtained weekly by parents using precut filter-paper strips. Serological detection of anti-HHV-6 antibodies was performed whenever a blood sample was taken from the child for other purposes.

Of the 81 children with a well-defined time of HHV-6 acquisition, 93% showed symptoms, most commonly fussiness (69%), rhinorrhea (65%), and fever (57%), with less-frequent occurrences of cough (33%), rash (31%), and diarrhea (26%).

Roseola, a clinical syndrome considered relatively specific for HHV-6, occurred in only 23% of the 81 children. No seizures were reported. This was “in contrast to emergency department-based studies, in which seizures occurred in as many as 13% of children with primary HHV-6 infection,” they wrote.

Previous serologic studies have shown that HHV-6 infects 90% of children by 2 years of age, and it has been estimated that 20% of emergency department visits for fever are due to primary HHV-6 infection.

The peak age of acquisition of primary human herpesvirus 6 infection is between 9 and 21 months, according to results of a population-based study of 277 children followed from birth to 2 years.

Of the 277, 130 (47%) of the children were infected by the age of 24 months (N.Engl. J. Med. 2005;352:768–76).

Human herpesvirus 6 (HHV-6) acquisition was associated with female sex (adjusted hazard ratio of 1.7 and having older siblings (adjusted hazard ratio of 2.1). Of the 227 children, 46% were female, and 52% had at least one sibling, said Danielle M. Zerr, M.D., of the department of pediatrics, the University of Washington, Seattle, and her colleagues.

HHV-6 infection was monitored using polymerase chain reaction on saliva samples obtained weekly by parents using precut filter-paper strips. Serological detection of anti-HHV-6 antibodies was performed whenever a blood sample was taken from the child for other purposes.

Of the 81 children with a well-defined time of HHV-6 acquisition, 93% showed symptoms, most commonly fussiness (69%), rhinorrhea (65%), and fever (57%), with less-frequent occurrences of cough (33%), rash (31%), and diarrhea (26%).

Roseola, a clinical syndrome considered relatively specific for HHV-6, occurred in only 23% of the 81 children. No seizures were reported. This was “in contrast to emergency department-based studies, in which seizures occurred in as many as 13% of children with primary HHV-6 infection,” they wrote.

Previous serologic studies have shown that HHV-6 infects 90% of children by 2 years of age, and it has been estimated that 20% of emergency department visits for fever are due to primary HHV-6 infection.

A 2-plus-1 dosing schedule of the commonly used pneumococcal conjugate vaccine showed satisfactory antibody responses to all serotypes of the bacteria, comparable with published immunogenicity studies on the usual 3-plus-1 dose schedule.

The descriptive, nonrandomized trial was performed on children at 3, 5, and 12 months of age, and 99 of 101 healthy infants completed the study, wrote Helena Käyhty, Ph.D., of the National Public Health Institute, Helsinki, Finland, and her colleagues.

The investigators compared the geometric mean antibody concentrations for all serotypes with published immunogenicity results, including those from two efficacy trials—the Northern California Kaiser-Permanente study and the Finnish Otitis Media Vaccine Trial—that used the standard 3-plus-1 schedule with different end points—invasive disease or acute otitis media. A similar German trial with a 3-plus-1 schedule was also compared with the present study; it measured a slightly lower incidence of fever, a common, usually mild symptom.

“At 13 months, 1 month after the third dose of [PCV7], antibody concentrations measured in this study were as high as those in the previous Finnish, U.S., and German studies and were distributed similarly with respect to those in the previous Finnish study after four doses, indicating equally good immunologic priming after two to three doses in early infancy,” they said (Pediatr. Infect. Dis. J. 2005;24:108–14).

Serious adverse events in four children were lethargy/irritability, gastroenteritis, and scarlatina; one was considered as possibly related to the vaccinations. “All serious adverse symptoms disappeared within 3–6 days,” they wrote.

The PCV7, marketed under the trade name Prevnar, is part of the universal vaccination program for U.S. children in a 3-plus-1 schedule, but in other parts of the world, vaccination with PCV7 is still uncommon, according to Dr. Käyhty.

Due to the results of this study, and because “preliminary postmarketing surveillance reports from the United States suggest that two doses in the primary series are sufficient for protection, although additional information on the duration of protection is needed,” the authors suggested that the use of fewer than four doses may be a practical option for the administration of PCV7.

A 2-plus-1 dosing schedule of the commonly used pneumococcal conjugate vaccine showed satisfactory antibody responses to all serotypes of the bacteria, comparable with published immunogenicity studies on the usual 3-plus-1 dose schedule.

The descriptive, nonrandomized trial was performed on children at 3, 5, and 12 months of age, and 99 of 101 healthy infants completed the study, wrote Helena Käyhty, Ph.D., of the National Public Health Institute, Helsinki, Finland, and her colleagues.

The investigators compared the geometric mean antibody concentrations for all serotypes with published immunogenicity results, including those from two efficacy trials—the Northern California Kaiser-Permanente study and the Finnish Otitis Media Vaccine Trial—that used the standard 3-plus-1 schedule with different end points—invasive disease or acute otitis media. A similar German trial with a 3-plus-1 schedule was also compared with the present study; it measured a slightly lower incidence of fever, a common, usually mild symptom.

“At 13 months, 1 month after the third dose of [PCV7], antibody concentrations measured in this study were as high as those in the previous Finnish, U.S., and German studies and were distributed similarly with respect to those in the previous Finnish study after four doses, indicating equally good immunologic priming after two to three doses in early infancy,” they said (Pediatr. Infect. Dis. J. 2005;24:108–14).

Serious adverse events in four children were lethargy/irritability, gastroenteritis, and scarlatina; one was considered as possibly related to the vaccinations. “All serious adverse symptoms disappeared within 3–6 days,” they wrote.

The PCV7, marketed under the trade name Prevnar, is part of the universal vaccination program for U.S. children in a 3-plus-1 schedule, but in other parts of the world, vaccination with PCV7 is still uncommon, according to Dr. Käyhty.

Due to the results of this study, and because “preliminary postmarketing surveillance reports from the United States suggest that two doses in the primary series are sufficient for protection, although additional information on the duration of protection is needed,” the authors suggested that the use of fewer than four doses may be a practical option for the administration of PCV7.

A 2-plus-1 dosing schedule of the commonly used pneumococcal conjugate vaccine showed satisfactory antibody responses to all serotypes of the bacteria, comparable with published immunogenicity studies on the usual 3-plus-1 dose schedule.

The descriptive, nonrandomized trial was performed on children at 3, 5, and 12 months of age, and 99 of 101 healthy infants completed the study, wrote Helena Käyhty, Ph.D., of the National Public Health Institute, Helsinki, Finland, and her colleagues.

The investigators compared the geometric mean antibody concentrations for all serotypes with published immunogenicity results, including those from two efficacy trials—the Northern California Kaiser-Permanente study and the Finnish Otitis Media Vaccine Trial—that used the standard 3-plus-1 schedule with different end points—invasive disease or acute otitis media. A similar German trial with a 3-plus-1 schedule was also compared with the present study; it measured a slightly lower incidence of fever, a common, usually mild symptom.

“At 13 months, 1 month after the third dose of [PCV7], antibody concentrations measured in this study were as high as those in the previous Finnish, U.S., and German studies and were distributed similarly with respect to those in the previous Finnish study after four doses, indicating equally good immunologic priming after two to three doses in early infancy,” they said (Pediatr. Infect. Dis. J. 2005;24:108–14).

Serious adverse events in four children were lethargy/irritability, gastroenteritis, and scarlatina; one was considered as possibly related to the vaccinations. “All serious adverse symptoms disappeared within 3–6 days,” they wrote.

The PCV7, marketed under the trade name Prevnar, is part of the universal vaccination program for U.S. children in a 3-plus-1 schedule, but in other parts of the world, vaccination with PCV7 is still uncommon, according to Dr. Käyhty.

Due to the results of this study, and because “preliminary postmarketing surveillance reports from the United States suggest that two doses in the primary series are sufficient for protection, although additional information on the duration of protection is needed,” the authors suggested that the use of fewer than four doses may be a practical option for the administration of PCV7.

WASHINGTON — Rapid expansion and new technologies are changing the face of newborn screening in the United States, experts and policy makers agreed at the annual meeting of the American Association for the Advancement of Science.

Michael Watson, Ph.D., of the American College of Medical Genetics outlined the rapidity of change. In 2002, around 30% of newborns in the United States were screened for fewer than 5 conditions, and only 5% for 20 or more. By October 2004, closer to 20% of newborns were screened for fewer than 5 conditions, and 27% were being screened for more than 20 conditions.

Only three conditions—phenylketonuria, galactosemia, and congenital hypothyroidism—are screened universally.

Tandem mass spectrometry in particular is driving an increase in the number and kind of diseases tested for, and it is changing the nature of state-run testing facilities, as outlined in a series of presentations at the meeting.

“There are very few things in medicine that are universal. Newborn screening is one of them. Hardly anyone slips through this net. But states vary enormously in what they screen for,” said Duane Alexander, M.D., director of the National Institute of Child Health and Human Development.

Because of this disparity, and the conviction that newborn screening has achieved only a fraction of its potential, the Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children was established in 2003.

The committee was authorized by Section 1111 of the Children's Health Act of 2000 to provide recommendations for a uniform panel of screening, and decision-making tools for the states to use in evaluating the future development of screening. Part of the committee's charge is to provide advice and recommendations on the funding of grants to the states for the improvement and/or expansion of newborn screening, as outlined in Section 1109 of the act.

The final report of the American College of Medical Genetics committee on the 78 conditions analyzed by the panel is available for public comment, and the secretary of Health and Human Services will evaluate it. Overall, the committee is recommending routine screening of 29 of the disorders considered, Dr. Watson said

According to Dr. Watson, the committee has already been having an effect on the evolution of newborn screening by its preliminary meetings, and its recommendation for screening 20 metabolic disorders with tandem mass spectrometry (MS).

Currently, more than half the states have instituted mandatory tandem MS screening, with several more having pilot studies or optional testing available, he said.

Tandem MS provides a complex profile of the metabolic status of an infant's blood sample. It is capable of simultaneously analyzing most compounds in a sample, giving both identification as well as concentration information. This can include information for diseases not mandated for screening by a particular program, as well as information on conditions that have no treatments, or ones that may have privacy implications.

“Having already determined that tandem MS ought to be part of a newborn screening program, we now are left with all of those other conditions that fall out of an MS profile,” Dr. Watson said. The committee has advocated the release of all clinically relevant data to practitioners and patients, regardless of the purpose of the initial screening.

Ultimately, newborn screening is likely to move into the genomics age, said James Hanson, M.D., of the NICHD. He suggested that, in future, DNA chips, proteomics, nanotechnology, and a variety of biophysical approaches will likely become part of this process. Luckily, for the easy evolution of screening, the standard heel-stick blood spots currently obtained are also appropriate for the majority of the new technologies.

Unfortunately, part of the long-term problem with the evolution—and cost—of newborn screening techniques involves competition from other forms of screening, such as for prostate cancer in adult men, and breast cancer in women. At some level, all these new screening methods inevitably compete for resources, Dr. Hanson said.

“Truth of the matter is, there is not enough money in the health care system the way it's applied for children at the present time to allow us to spend all we would like for every patient or child with a rare disorder,” Dr. Hanson said. “It is deplorable from an ethical standpoint but is a practical reality at the present time.”

Such cost considerations are likely to increase as screening proliferates. According to Piero Rinaldo, M.D., a pediatric geneticist at the Mayo Clinic, Rochester, Minn., there are also moves to expand screening beyond the newborn stage to capture disorders such as Wilson's disease—a hereditary disorder that causes copper to build up to toxic levels—and congenital disorders of glycosylation, none of which are detectable until later in an infant's life.

Public comment can be mailed to Maternal and Child Health Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Parklawn Building 18A-19, Rockville, MD 20857; faxed to 301-443-8604; or e-mailed to [email protected]

WASHINGTON — Rapid expansion and new technologies are changing the face of newborn screening in the United States, experts and policy makers agreed at the annual meeting of the American Association for the Advancement of Science.

Michael Watson, Ph.D., of the American College of Medical Genetics outlined the rapidity of change. In 2002, around 30% of newborns in the United States were screened for fewer than 5 conditions, and only 5% for 20 or more. By October 2004, closer to 20% of newborns were screened for fewer than 5 conditions, and 27% were being screened for more than 20 conditions.

Only three conditions—phenylketonuria, galactosemia, and congenital hypothyroidism—are screened universally.

Tandem mass spectrometry in particular is driving an increase in the number and kind of diseases tested for, and it is changing the nature of state-run testing facilities, as outlined in a series of presentations at the meeting.

“There are very few things in medicine that are universal. Newborn screening is one of them. Hardly anyone slips through this net. But states vary enormously in what they screen for,” said Duane Alexander, M.D., director of the National Institute of Child Health and Human Development.

Because of this disparity, and the conviction that newborn screening has achieved only a fraction of its potential, the Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children was established in 2003.

The committee was authorized by Section 1111 of the Children's Health Act of 2000 to provide recommendations for a uniform panel of screening, and decision-making tools for the states to use in evaluating the future development of screening. Part of the committee's charge is to provide advice and recommendations on the funding of grants to the states for the improvement and/or expansion of newborn screening, as outlined in Section 1109 of the act.

The final report of the American College of Medical Genetics committee on the 78 conditions analyzed by the panel is available for public comment, and the secretary of Health and Human Services will evaluate it. Overall, the committee is recommending routine screening of 29 of the disorders considered, Dr. Watson said

According to Dr. Watson, the committee has already been having an effect on the evolution of newborn screening by its preliminary meetings, and its recommendation for screening 20 metabolic disorders with tandem mass spectrometry (MS).

Currently, more than half the states have instituted mandatory tandem MS screening, with several more having pilot studies or optional testing available, he said.

Tandem MS provides a complex profile of the metabolic status of an infant's blood sample. It is capable of simultaneously analyzing most compounds in a sample, giving both identification as well as concentration information. This can include information for diseases not mandated for screening by a particular program, as well as information on conditions that have no treatments, or ones that may have privacy implications.

“Having already determined that tandem MS ought to be part of a newborn screening program, we now are left with all of those other conditions that fall out of an MS profile,” Dr. Watson said. The committee has advocated the release of all clinically relevant data to practitioners and patients, regardless of the purpose of the initial screening.

Ultimately, newborn screening is likely to move into the genomics age, said James Hanson, M.D., of the NICHD. He suggested that, in future, DNA chips, proteomics, nanotechnology, and a variety of biophysical approaches will likely become part of this process. Luckily, for the easy evolution of screening, the standard heel-stick blood spots currently obtained are also appropriate for the majority of the new technologies.

Unfortunately, part of the long-term problem with the evolution—and cost—of newborn screening techniques involves competition from other forms of screening, such as for prostate cancer in adult men, and breast cancer in women. At some level, all these new screening methods inevitably compete for resources, Dr. Hanson said.

“Truth of the matter is, there is not enough money in the health care system the way it's applied for children at the present time to allow us to spend all we would like for every patient or child with a rare disorder,” Dr. Hanson said. “It is deplorable from an ethical standpoint but is a practical reality at the present time.”

Such cost considerations are likely to increase as screening proliferates. According to Piero Rinaldo, M.D., a pediatric geneticist at the Mayo Clinic, Rochester, Minn., there are also moves to expand screening beyond the newborn stage to capture disorders such as Wilson's disease—a hereditary disorder that causes copper to build up to toxic levels—and congenital disorders of glycosylation, none of which are detectable until later in an infant's life.

Public comment can be mailed to Maternal and Child Health Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Parklawn Building 18A-19, Rockville, MD 20857; faxed to 301-443-8604; or e-mailed to [email protected]

WASHINGTON — Rapid expansion and new technologies are changing the face of newborn screening in the United States, experts and policy makers agreed at the annual meeting of the American Association for the Advancement of Science.

Michael Watson, Ph.D., of the American College of Medical Genetics outlined the rapidity of change. In 2002, around 30% of newborns in the United States were screened for fewer than 5 conditions, and only 5% for 20 or more. By October 2004, closer to 20% of newborns were screened for fewer than 5 conditions, and 27% were being screened for more than 20 conditions.

Only three conditions—phenylketonuria, galactosemia, and congenital hypothyroidism—are screened universally.

Tandem mass spectrometry in particular is driving an increase in the number and kind of diseases tested for, and it is changing the nature of state-run testing facilities, as outlined in a series of presentations at the meeting.

“There are very few things in medicine that are universal. Newborn screening is one of them. Hardly anyone slips through this net. But states vary enormously in what they screen for,” said Duane Alexander, M.D., director of the National Institute of Child Health and Human Development.

Because of this disparity, and the conviction that newborn screening has achieved only a fraction of its potential, the Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children was established in 2003.

The committee was authorized by Section 1111 of the Children's Health Act of 2000 to provide recommendations for a uniform panel of screening, and decision-making tools for the states to use in evaluating the future development of screening. Part of the committee's charge is to provide advice and recommendations on the funding of grants to the states for the improvement and/or expansion of newborn screening, as outlined in Section 1109 of the act.

The final report of the American College of Medical Genetics committee on the 78 conditions analyzed by the panel is available for public comment, and the secretary of Health and Human Services will evaluate it. Overall, the committee is recommending routine screening of 29 of the disorders considered, Dr. Watson said

According to Dr. Watson, the committee has already been having an effect on the evolution of newborn screening by its preliminary meetings, and its recommendation for screening 20 metabolic disorders with tandem mass spectrometry (MS).

Currently, more than half the states have instituted mandatory tandem MS screening, with several more having pilot studies or optional testing available, he said.

Tandem MS provides a complex profile of the metabolic status of an infant's blood sample. It is capable of simultaneously analyzing most compounds in a sample, giving both identification as well as concentration information. This can include information for diseases not mandated for screening by a particular program, as well as information on conditions that have no treatments, or ones that may have privacy implications.

“Having already determined that tandem MS ought to be part of a newborn screening program, we now are left with all of those other conditions that fall out of an MS profile,” Dr. Watson said. The committee has advocated the release of all clinically relevant data to practitioners and patients, regardless of the purpose of the initial screening.

Ultimately, newborn screening is likely to move into the genomics age, said James Hanson, M.D., of the NICHD. He suggested that, in future, DNA chips, proteomics, nanotechnology, and a variety of biophysical approaches will likely become part of this process. Luckily, for the easy evolution of screening, the standard heel-stick blood spots currently obtained are also appropriate for the majority of the new technologies.

Unfortunately, part of the long-term problem with the evolution—and cost—of newborn screening techniques involves competition from other forms of screening, such as for prostate cancer in adult men, and breast cancer in women. At some level, all these new screening methods inevitably compete for resources, Dr. Hanson said.

“Truth of the matter is, there is not enough money in the health care system the way it's applied for children at the present time to allow us to spend all we would like for every patient or child with a rare disorder,” Dr. Hanson said. “It is deplorable from an ethical standpoint but is a practical reality at the present time.”

Such cost considerations are likely to increase as screening proliferates. According to Piero Rinaldo, M.D., a pediatric geneticist at the Mayo Clinic, Rochester, Minn., there are also moves to expand screening beyond the newborn stage to capture disorders such as Wilson's disease—a hereditary disorder that causes copper to build up to toxic levels—and congenital disorders of glycosylation, none of which are detectable until later in an infant's life.

Public comment can be mailed to Maternal and Child Health Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Parklawn Building 18A-19, Rockville, MD 20857; faxed to 301-443-8604; or e-mailed to [email protected]

Medicare has agreed to reimburse for vertebral fracture assessment by dual-energy x-ray absorptiometry using the newly approved CPT code 76077, according to the International Society for Clinical Densitometry.

“Vertebral fractures are a powerful barometer in predicting future bone fragility in a patient,” said E. Michael Lewiecki, M.D., osteoporosis director of the New Mexico Clinical Research & Osteoporosis Center in Albuquerque, and president of the ISCD. “The new code gives physicians the opportunity to accurately evaluate a patient's future fracture risk and therefore improve the accuracy of the diagnosis.”

Previous vertebral fracture is a major risk factor for future fragility fractures. “Vertebral fractures are present in about one-third of women over age 65 and are highly related to increased fracture risk at the spine and hip independent of a patient's bone density,” according to Hologic Inc., one of two manufacturers of the dual-energy x-ray absorptiometry (DXA) systems covered under the new code. Women with such fractures also have less ability to perform daily activities and a significantly higher morbidity, the company added.

Vertebral fracture assessment (VFA) also is a more sensitive measure of identifying osteoporosis than is bone mineral density analysis.

“Based upon BMD alone and the central site measured, 11%-18% of women with vertebral fractures would have been classified as normal,” according to Vance J. Bray, M.D., of the Denver Arthritis Clinic, in a report in the ISCD newsletter, Osteoflash. Such vertebral deformities occur in approximately 11 per 100 women aged 50-59 years and in 54 per 100 women aged 80 years and older, according to Dr. Bray.

The CPT is a continually updated listing of descriptive terms and identifying codes developed and maintained by the American Medical Association. Physicians use CPT codes to refer to (and to report providing) medical services and procedures.

The CPT is the most widely accepted nomenclature used for service claims under private and public health insurance programs. Implementation of a new code is recognition of the importance of a new procedure and a vehicle for its inclusion in insurance claims for reimbursement.

The ISCD testified to the AMA about the value of this technique to facilitate approval of the new code.

The Health Insurance Portability and Accountability Act of 1996 requires that the most current code be used in all covered health care transactions and the new code must be used for dates of service starting Jan. 1, 2005.

The Centers for Medicare and Medicaid Services reimbursement for VFA is set for a national average of about $40, according to Dr. Bray.

Reimbursement for this new imaging technique recognizes its importance, according to the ISCD. “Health care providers will be able to use VFA to select those patients who are at the highest risk for fractures and structure treatment plans to be most beneficial and cost effective,” the organization said.

ISCD is developing educational programs to teach physicians high-quality acquisition and interpretation of vertebral fracture assessment using DXA technology.

In February 2005, the ISCD annual meeting in New Orleans will offer an updated bone densitometry class that will incorporate one-hour VFA introductory lectures for clinicians and technologists. Criteria for the performance of VFA are being developed by an ISCD task force and will be discussed at the 2005 ISCD Position Development Conference in Vancouver, B.C., in July, according to Dr. Bray.

DXA has been called the “gold standard” of analysis for measurement of bone mineral density and will continue to be covered by CPT code 76075 for that purpose.

Medicare has agreed to reimburse for vertebral fracture assessment by dual-energy x-ray absorptiometry using the newly approved CPT code 76077, according to the International Society for Clinical Densitometry.

“Vertebral fractures are a powerful barometer in predicting future bone fragility in a patient,” said E. Michael Lewiecki, M.D., osteoporosis director of the New Mexico Clinical Research & Osteoporosis Center in Albuquerque, and president of the ISCD. “The new code gives physicians the opportunity to accurately evaluate a patient's future fracture risk and therefore improve the accuracy of the diagnosis.”

Previous vertebral fracture is a major risk factor for future fragility fractures. “Vertebral fractures are present in about one-third of women over age 65 and are highly related to increased fracture risk at the spine and hip independent of a patient's bone density,” according to Hologic Inc., one of two manufacturers of the dual-energy x-ray absorptiometry (DXA) systems covered under the new code. Women with such fractures also have less ability to perform daily activities and a significantly higher morbidity, the company added.

Vertebral fracture assessment (VFA) also is a more sensitive measure of identifying osteoporosis than is bone mineral density analysis.

“Based upon BMD alone and the central site measured, 11%-18% of women with vertebral fractures would have been classified as normal,” according to Vance J. Bray, M.D., of the Denver Arthritis Clinic, in a report in the ISCD newsletter, Osteoflash. Such vertebral deformities occur in approximately 11 per 100 women aged 50-59 years and in 54 per 100 women aged 80 years and older, according to Dr. Bray.

The CPT is a continually updated listing of descriptive terms and identifying codes developed and maintained by the American Medical Association. Physicians use CPT codes to refer to (and to report providing) medical services and procedures.

The CPT is the most widely accepted nomenclature used for service claims under private and public health insurance programs. Implementation of a new code is recognition of the importance of a new procedure and a vehicle for its inclusion in insurance claims for reimbursement.

The ISCD testified to the AMA about the value of this technique to facilitate approval of the new code.

The Health Insurance Portability and Accountability Act of 1996 requires that the most current code be used in all covered health care transactions and the new code must be used for dates of service starting Jan. 1, 2005.

The Centers for Medicare and Medicaid Services reimbursement for VFA is set for a national average of about $40, according to Dr. Bray.

Reimbursement for this new imaging technique recognizes its importance, according to the ISCD. “Health care providers will be able to use VFA to select those patients who are at the highest risk for fractures and structure treatment plans to be most beneficial and cost effective,” the organization said.

ISCD is developing educational programs to teach physicians high-quality acquisition and interpretation of vertebral fracture assessment using DXA technology.

In February 2005, the ISCD annual meeting in New Orleans will offer an updated bone densitometry class that will incorporate one-hour VFA introductory lectures for clinicians and technologists. Criteria for the performance of VFA are being developed by an ISCD task force and will be discussed at the 2005 ISCD Position Development Conference in Vancouver, B.C., in July, according to Dr. Bray.

DXA has been called the “gold standard” of analysis for measurement of bone mineral density and will continue to be covered by CPT code 76075 for that purpose.

Medicare has agreed to reimburse for vertebral fracture assessment by dual-energy x-ray absorptiometry using the newly approved CPT code 76077, according to the International Society for Clinical Densitometry.

“Vertebral fractures are a powerful barometer in predicting future bone fragility in a patient,” said E. Michael Lewiecki, M.D., osteoporosis director of the New Mexico Clinical Research & Osteoporosis Center in Albuquerque, and president of the ISCD. “The new code gives physicians the opportunity to accurately evaluate a patient's future fracture risk and therefore improve the accuracy of the diagnosis.”

Previous vertebral fracture is a major risk factor for future fragility fractures. “Vertebral fractures are present in about one-third of women over age 65 and are highly related to increased fracture risk at the spine and hip independent of a patient's bone density,” according to Hologic Inc., one of two manufacturers of the dual-energy x-ray absorptiometry (DXA) systems covered under the new code. Women with such fractures also have less ability to perform daily activities and a significantly higher morbidity, the company added.

Vertebral fracture assessment (VFA) also is a more sensitive measure of identifying osteoporosis than is bone mineral density analysis.

“Based upon BMD alone and the central site measured, 11%-18% of women with vertebral fractures would have been classified as normal,” according to Vance J. Bray, M.D., of the Denver Arthritis Clinic, in a report in the ISCD newsletter, Osteoflash. Such vertebral deformities occur in approximately 11 per 100 women aged 50-59 years and in 54 per 100 women aged 80 years and older, according to Dr. Bray.

The CPT is a continually updated listing of descriptive terms and identifying codes developed and maintained by the American Medical Association. Physicians use CPT codes to refer to (and to report providing) medical services and procedures.

The CPT is the most widely accepted nomenclature used for service claims under private and public health insurance programs. Implementation of a new code is recognition of the importance of a new procedure and a vehicle for its inclusion in insurance claims for reimbursement.

The ISCD testified to the AMA about the value of this technique to facilitate approval of the new code.

The Health Insurance Portability and Accountability Act of 1996 requires that the most current code be used in all covered health care transactions and the new code must be used for dates of service starting Jan. 1, 2005.

The Centers for Medicare and Medicaid Services reimbursement for VFA is set for a national average of about $40, according to Dr. Bray.

Reimbursement for this new imaging technique recognizes its importance, according to the ISCD. “Health care providers will be able to use VFA to select those patients who are at the highest risk for fractures and structure treatment plans to be most beneficial and cost effective,” the organization said.

ISCD is developing educational programs to teach physicians high-quality acquisition and interpretation of vertebral fracture assessment using DXA technology.

In February 2005, the ISCD annual meeting in New Orleans will offer an updated bone densitometry class that will incorporate one-hour VFA introductory lectures for clinicians and technologists. Criteria for the performance of VFA are being developed by an ISCD task force and will be discussed at the 2005 ISCD Position Development Conference in Vancouver, B.C., in July, according to Dr. Bray.

DXA has been called the “gold standard” of analysis for measurement of bone mineral density and will continue to be covered by CPT code 76075 for that purpose.

Postoperative nausea and vomiting can be limited in a high-risk population by the use of preoperative intravenous fluid therapy tied to the length of presurgery fasting, reported C.H. Maharaj, M.B., and colleagues from the National University of Ireland, Galway.

Postoperative nausea and vomiting (PONV) can cause great patient distress and increase costs because of the need for additional care. Current treatment options for PONV are limited. More than 25% of patients experience PONV within 24 hours of surgery, according to Dr. Maharaj and colleagues (Anesth. Analg. 2005;100:675-82).

In their randomized, double-blind, controlled study of 80 patients scheduled to undergo diagnostic gynecologic laparoscopy, the researchers compared the effects of preoperative administration of a large volume of compound sodium lactate (2.0 mL/kg per hour of fasting) with a smaller control infusion (single bolus of 3 mL/kg). PONV, pain, and the need to postoperatively administer antiemetics and analgesic drugs were assessed.

The incidence of PONV in the first 72 hours was significantly lower in the 41 patients in the large-volume group (59%) than in the 39 control patients (87%). The number of treated patients needed to prevent an occurrence of PONV was 3.45. Mean postoperative verbal analog scores, nausea scores, pain scores, and mean worst pain scores were significantly lower in the large-volume group than in the control group. In addition, postoperative supplemental analgesic requirements, both in number of patients needing medication and in amount of medication needed, were significantly lower in the large-volume group.

Postoperative nausea and vomiting can be limited in a high-risk population by the use of preoperative intravenous fluid therapy tied to the length of presurgery fasting, reported C.H. Maharaj, M.B., and colleagues from the National University of Ireland, Galway.

Postoperative nausea and vomiting (PONV) can cause great patient distress and increase costs because of the need for additional care. Current treatment options for PONV are limited. More than 25% of patients experience PONV within 24 hours of surgery, according to Dr. Maharaj and colleagues (Anesth. Analg. 2005;100:675-82).

In their randomized, double-blind, controlled study of 80 patients scheduled to undergo diagnostic gynecologic laparoscopy, the researchers compared the effects of preoperative administration of a large volume of compound sodium lactate (2.0 mL/kg per hour of fasting) with a smaller control infusion (single bolus of 3 mL/kg). PONV, pain, and the need to postoperatively administer antiemetics and analgesic drugs were assessed.

The incidence of PONV in the first 72 hours was significantly lower in the 41 patients in the large-volume group (59%) than in the 39 control patients (87%). The number of treated patients needed to prevent an occurrence of PONV was 3.45. Mean postoperative verbal analog scores, nausea scores, pain scores, and mean worst pain scores were significantly lower in the large-volume group than in the control group. In addition, postoperative supplemental analgesic requirements, both in number of patients needing medication and in amount of medication needed, were significantly lower in the large-volume group.

Postoperative nausea and vomiting can be limited in a high-risk population by the use of preoperative intravenous fluid therapy tied to the length of presurgery fasting, reported C.H. Maharaj, M.B., and colleagues from the National University of Ireland, Galway.

Postoperative nausea and vomiting (PONV) can cause great patient distress and increase costs because of the need for additional care. Current treatment options for PONV are limited. More than 25% of patients experience PONV within 24 hours of surgery, according to Dr. Maharaj and colleagues (Anesth. Analg. 2005;100:675-82).

In their randomized, double-blind, controlled study of 80 patients scheduled to undergo diagnostic gynecologic laparoscopy, the researchers compared the effects of preoperative administration of a large volume of compound sodium lactate (2.0 mL/kg per hour of fasting) with a smaller control infusion (single bolus of 3 mL/kg). PONV, pain, and the need to postoperatively administer antiemetics and analgesic drugs were assessed.

The incidence of PONV in the first 72 hours was significantly lower in the 41 patients in the large-volume group (59%) than in the 39 control patients (87%). The number of treated patients needed to prevent an occurrence of PONV was 3.45. Mean postoperative verbal analog scores, nausea scores, pain scores, and mean worst pain scores were significantly lower in the large-volume group than in the control group. In addition, postoperative supplemental analgesic requirements, both in number of patients needing medication and in amount of medication needed, were significantly lower in the large-volume group.

Treatment of uncomplicated acute otitis media with single-dose azithromycin proved comparable in efficacy to the standard high-dose amoxicillin in an international trial of young children.

Azithromycin treatment for acute otitis media (AOM) also showed fewer adverse events and greater patient compliance in the randomized, double-blind, double-dummy trial, reported Adriano Arguedas, M.D., of the Instituto de Atención Pediátrica, San José, Costa Rica, and colleagues.

In a trial conducted at centers in Chile, Costa Rica, Finland, and the United States, 312 children 6-30 months of age with AOM were divided into two study populations (Pediatr. Infect. Dis. J. 2005;24:153-61).

The 158 patients in the azithromycin group received a single dose of the drug (30 mg/kg) plus 10 days of an amoxicillin placebo at 90 mg/kg per day, in two divided doses. The 154 patients in the amoxicillin group received an azithromycin placebo and 10 days of authentic amoxicillin. Clinical success was reported as cure or improvement at end of therapy and maintenance of cure at end of study. It was not significantly different between the treatments. Rates at end of therapy were 84% for each antibiotic for all patients and 82% for each antibiotic for children 2 years of age or younger. Rates at end of study for all patients were 77% for azithromycin and 78% for amoxicillin and 75% for both antibiotics for children aged 2 years and younger.

The rates of treatment-related adverse events for azithromycin and amoxicillin were 20% and 29%, respectively. Although adverse events rates were not significantly different overall, significant differences were seen in the incidence of diarrhea, which was greater with amoxicillin than with azithromycin (17.5% vs. 8.2%).

Compliance, defined as completion of at least 80% of the prescribed study medication, was significantly greater in the azithromycin group (100% vs. 90%).

The authors concluded single-dose azithromycin was noninferior to standard high-dose amoxicillin. The study was supported by a grant from Pfizer Inc., which makes azithromycin (Zithromax).

Treatment of uncomplicated acute otitis media with single-dose azithromycin proved comparable in efficacy to the standard high-dose amoxicillin in an international trial of young children.

Azithromycin treatment for acute otitis media (AOM) also showed fewer adverse events and greater patient compliance in the randomized, double-blind, double-dummy trial, reported Adriano Arguedas, M.D., of the Instituto de Atención Pediátrica, San José, Costa Rica, and colleagues.

In a trial conducted at centers in Chile, Costa Rica, Finland, and the United States, 312 children 6-30 months of age with AOM were divided into two study populations (Pediatr. Infect. Dis. J. 2005;24:153-61).

The 158 patients in the azithromycin group received a single dose of the drug (30 mg/kg) plus 10 days of an amoxicillin placebo at 90 mg/kg per day, in two divided doses. The 154 patients in the amoxicillin group received an azithromycin placebo and 10 days of authentic amoxicillin. Clinical success was reported as cure or improvement at end of therapy and maintenance of cure at end of study. It was not significantly different between the treatments. Rates at end of therapy were 84% for each antibiotic for all patients and 82% for each antibiotic for children 2 years of age or younger. Rates at end of study for all patients were 77% for azithromycin and 78% for amoxicillin and 75% for both antibiotics for children aged 2 years and younger.

The rates of treatment-related adverse events for azithromycin and amoxicillin were 20% and 29%, respectively. Although adverse events rates were not significantly different overall, significant differences were seen in the incidence of diarrhea, which was greater with amoxicillin than with azithromycin (17.5% vs. 8.2%).

Compliance, defined as completion of at least 80% of the prescribed study medication, was significantly greater in the azithromycin group (100% vs. 90%).

The authors concluded single-dose azithromycin was noninferior to standard high-dose amoxicillin. The study was supported by a grant from Pfizer Inc., which makes azithromycin (Zithromax).

Treatment of uncomplicated acute otitis media with single-dose azithromycin proved comparable in efficacy to the standard high-dose amoxicillin in an international trial of young children.

Azithromycin treatment for acute otitis media (AOM) also showed fewer adverse events and greater patient compliance in the randomized, double-blind, double-dummy trial, reported Adriano Arguedas, M.D., of the Instituto de Atención Pediátrica, San José, Costa Rica, and colleagues.

In a trial conducted at centers in Chile, Costa Rica, Finland, and the United States, 312 children 6-30 months of age with AOM were divided into two study populations (Pediatr. Infect. Dis. J. 2005;24:153-61).

The 158 patients in the azithromycin group received a single dose of the drug (30 mg/kg) plus 10 days of an amoxicillin placebo at 90 mg/kg per day, in two divided doses. The 154 patients in the amoxicillin group received an azithromycin placebo and 10 days of authentic amoxicillin. Clinical success was reported as cure or improvement at end of therapy and maintenance of cure at end of study. It was not significantly different between the treatments. Rates at end of therapy were 84% for each antibiotic for all patients and 82% for each antibiotic for children 2 years of age or younger. Rates at end of study for all patients were 77% for azithromycin and 78% for amoxicillin and 75% for both antibiotics for children aged 2 years and younger.

The rates of treatment-related adverse events for azithromycin and amoxicillin were 20% and 29%, respectively. Although adverse events rates were not significantly different overall, significant differences were seen in the incidence of diarrhea, which was greater with amoxicillin than with azithromycin (17.5% vs. 8.2%).

Compliance, defined as completion of at least 80% of the prescribed study medication, was significantly greater in the azithromycin group (100% vs. 90%).

The authors concluded single-dose azithromycin was noninferior to standard high-dose amoxicillin. The study was supported by a grant from Pfizer Inc., which makes azithromycin (Zithromax).