Sherry Boschert

SAN FRANCISCO — Hard on the heels of approval of the 13-valent pneumococcal conjugate vaccine in early 2010, tests of a 15-valent pneumococcal conjugate vaccine are underway, and researchers are looking for new strategies beyond adding more and more pneumococcal serotypes to the vaccine.

“We can't keep adding new serotypes. There are 92 serotypes,” Dr. Sheldon L. Kaplan said at the meeting. One target may be a vaccine that's directed against noncapsular epitopes, suggested Dr. Kaplan, professor of pediatrics and head of the pediatric infectious diseases section at Baylor College of Medicine, Houston.

Meanwhile, the experimental 15-valent pneumococcal conjugate vaccine (PCV15) would add serotypes 22F and 33F – two of the five most common serotypes seen in invasive pneumococcal disease today. Since the introduction of the first 7-valent pneumococcal conjugate vaccine (PCV7) in 2000, invasive disease from those seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) has nearly disappeared, but disease from non-PCV7 serotypes has been on the rise since at least 2004.

In 2006–2007, 5% of isolates from invasive pneumococcal disease in children younger than 5 years old contained serotype 22F, and 5% contained 33F, which promoted these isolates to candidates for the PCV15 vaccine (J. Infect. Dis. 2010;201: 32–41).

The most important serotype accounting for nearly half of invasive pneumococcal disease since introduction of the PCV7 vaccine – serotype 19A – was added to the 13-valent pneumococcal vaccine (PCV13) that was licensed in early 2010. The 200–2007 data showed that 47% of invasive pneumococcal infections in children under 5 years of age was due to serotype 19A. Other data show that perhaps half of 19A isolates are resistant to three or more classes of antibiotics.

The PCV13 vaccine (Prevnar 13, made by Wyeth Pharmaceuticals Inc. and marketed by Pfizer Inc.) also added serotypes 1, 3, 5, 6A, and 7F. “Serotypes 1 and 3 are very important causes of pneumonia, especially pneumonia with empyema. We don't see much serotype 5 in the United States, so it's not going to make much of an impact there,” Dr. Kaplan said.

The success of PCV7 stokes hopes that PCV13 could have an equally dramatic impact. “I think we're going to see a major decline in invasive disease due to adding these nonvaccine serotypes to the PCV13,” perhaps reducing the current numbers of invasive pneumococcal disease by 70%, he added.

The Advisory Committee on Immunization Practices (ACIP) and the Red Book by the American Academy of Pediatrics' Committee on Infectious Diseases recommend administering PCV13 routinely to children at 2 months of age and suggest a catch-up schedule for children with incomplete vaccination histories.

Centers for Disease Control and Prevention monitoring after introduction of the PCV7 vaccine showed a 70%–75% reduction in overall invasive pneumococcal disease, Dr. Kaplan said.

His institution is part of a coalition of eight children's hospitals that have been monitoring invasive pneumococcal disease since 1994, covering a surveillance population of around 19 million people. Cases of invasive pneumococcal disease decreased from an average of 400–500 cases per year before the PCV7 vaccine to a nadir of 100–200 cases per year in 2004, but the number has slowly crept up since then to 221 cases in 2009, he said (Pediatrics 2010;125:429-36).

As in CDC data, serotype 19A accounts for about half of invasive pneumococcal disease cases in the network's surveillance, he added. The network data also show that the most prominent type of infection before PCV7, bacteremia, fell from approximately 60% of cases to around 40% of cases post-PCV7. Pneumonia increased from 20% of cases to 30%, and the proportion of isolates associated with bacterial meningitis remained relatively steady, between 11% and 17%.

“In our multicenter study, cases of culture-proven pneumococcal pneumonia declined from 80–100 kids per year to about 40–50 cases/year in 2004, and have slowly climbed back up to more than 60 cases per year,” entirely due to serotypes not included in PCV7, Dr. Kaplan said.

Although PCV7 was associated with a modest decline in cases of acute otitis media and in the use of antibiotics to treat AOM, at least until 2004, multidrug-resistant serotype 19A is playing a larger role in AOM. “In our studies, 19A accounts for about 60% of pneumococcal isolates recovered from children who have draining ears, myringotomies,” and pressure equalization tubes, he said. “As a result, we're seeing an increasing number of kids with pneumococcal mastoiditis,” he added. Mastoiditis cases declined from around 5–10 cases per year before PCV7 to 3–4 cases per year, but have totaled 15–25 cases per year in the past few years. The main serotype associated with mastoiditis is 19A, but serotype 3 also plays an important role, he said. Both are included in PCV13.

Dr. Kaplan has received grants from Pfizer Inc. and Sanofi Pasteur for investigator-initiated studies, and is a member of pediatric advisory committees for Pfizer, Novartis, and Sanofi Pasteur. He said he has received honoraria from Pfizer, Novartis, GlaxoSmithKline, and Sanofi Pasteur.

'We can't keep adding new serotypes. There are 92 serotypes.'

Source DR. KAPLAN

SAN FRANCISCO — Hard on the heels of approval of the 13-valent pneumococcal conjugate vaccine in early 2010, tests of a 15-valent pneumococcal conjugate vaccine are underway, and researchers are looking for new strategies beyond adding more and more pneumococcal serotypes to the vaccine.

“We can't keep adding new serotypes. There are 92 serotypes,” Dr. Sheldon L. Kaplan said at the meeting. One target may be a vaccine that's directed against noncapsular epitopes, suggested Dr. Kaplan, professor of pediatrics and head of the pediatric infectious diseases section at Baylor College of Medicine, Houston.

Meanwhile, the experimental 15-valent pneumococcal conjugate vaccine (PCV15) would add serotypes 22F and 33F – two of the five most common serotypes seen in invasive pneumococcal disease today. Since the introduction of the first 7-valent pneumococcal conjugate vaccine (PCV7) in 2000, invasive disease from those seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) has nearly disappeared, but disease from non-PCV7 serotypes has been on the rise since at least 2004.

In 2006–2007, 5% of isolates from invasive pneumococcal disease in children younger than 5 years old contained serotype 22F, and 5% contained 33F, which promoted these isolates to candidates for the PCV15 vaccine (J. Infect. Dis. 2010;201: 32–41).

The most important serotype accounting for nearly half of invasive pneumococcal disease since introduction of the PCV7 vaccine – serotype 19A – was added to the 13-valent pneumococcal vaccine (PCV13) that was licensed in early 2010. The 200–2007 data showed that 47% of invasive pneumococcal infections in children under 5 years of age was due to serotype 19A. Other data show that perhaps half of 19A isolates are resistant to three or more classes of antibiotics.

The PCV13 vaccine (Prevnar 13, made by Wyeth Pharmaceuticals Inc. and marketed by Pfizer Inc.) also added serotypes 1, 3, 5, 6A, and 7F. “Serotypes 1 and 3 are very important causes of pneumonia, especially pneumonia with empyema. We don't see much serotype 5 in the United States, so it's not going to make much of an impact there,” Dr. Kaplan said.

The success of PCV7 stokes hopes that PCV13 could have an equally dramatic impact. “I think we're going to see a major decline in invasive disease due to adding these nonvaccine serotypes to the PCV13,” perhaps reducing the current numbers of invasive pneumococcal disease by 70%, he added.

The Advisory Committee on Immunization Practices (ACIP) and the Red Book by the American Academy of Pediatrics' Committee on Infectious Diseases recommend administering PCV13 routinely to children at 2 months of age and suggest a catch-up schedule for children with incomplete vaccination histories.

Centers for Disease Control and Prevention monitoring after introduction of the PCV7 vaccine showed a 70%–75% reduction in overall invasive pneumococcal disease, Dr. Kaplan said.

His institution is part of a coalition of eight children's hospitals that have been monitoring invasive pneumococcal disease since 1994, covering a surveillance population of around 19 million people. Cases of invasive pneumococcal disease decreased from an average of 400–500 cases per year before the PCV7 vaccine to a nadir of 100–200 cases per year in 2004, but the number has slowly crept up since then to 221 cases in 2009, he said (Pediatrics 2010;125:429-36).

As in CDC data, serotype 19A accounts for about half of invasive pneumococcal disease cases in the network's surveillance, he added. The network data also show that the most prominent type of infection before PCV7, bacteremia, fell from approximately 60% of cases to around 40% of cases post-PCV7. Pneumonia increased from 20% of cases to 30%, and the proportion of isolates associated with bacterial meningitis remained relatively steady, between 11% and 17%.

“In our multicenter study, cases of culture-proven pneumococcal pneumonia declined from 80–100 kids per year to about 40–50 cases/year in 2004, and have slowly climbed back up to more than 60 cases per year,” entirely due to serotypes not included in PCV7, Dr. Kaplan said.

Although PCV7 was associated with a modest decline in cases of acute otitis media and in the use of antibiotics to treat AOM, at least until 2004, multidrug-resistant serotype 19A is playing a larger role in AOM. “In our studies, 19A accounts for about 60% of pneumococcal isolates recovered from children who have draining ears, myringotomies,” and pressure equalization tubes, he said. “As a result, we're seeing an increasing number of kids with pneumococcal mastoiditis,” he added. Mastoiditis cases declined from around 5–10 cases per year before PCV7 to 3–4 cases per year, but have totaled 15–25 cases per year in the past few years. The main serotype associated with mastoiditis is 19A, but serotype 3 also plays an important role, he said. Both are included in PCV13.

Dr. Kaplan has received grants from Pfizer Inc. and Sanofi Pasteur for investigator-initiated studies, and is a member of pediatric advisory committees for Pfizer, Novartis, and Sanofi Pasteur. He said he has received honoraria from Pfizer, Novartis, GlaxoSmithKline, and Sanofi Pasteur.

'We can't keep adding new serotypes. There are 92 serotypes.'

Source DR. KAPLAN

SAN FRANCISCO — Hard on the heels of approval of the 13-valent pneumococcal conjugate vaccine in early 2010, tests of a 15-valent pneumococcal conjugate vaccine are underway, and researchers are looking for new strategies beyond adding more and more pneumococcal serotypes to the vaccine.

“We can't keep adding new serotypes. There are 92 serotypes,” Dr. Sheldon L. Kaplan said at the meeting. One target may be a vaccine that's directed against noncapsular epitopes, suggested Dr. Kaplan, professor of pediatrics and head of the pediatric infectious diseases section at Baylor College of Medicine, Houston.

Meanwhile, the experimental 15-valent pneumococcal conjugate vaccine (PCV15) would add serotypes 22F and 33F – two of the five most common serotypes seen in invasive pneumococcal disease today. Since the introduction of the first 7-valent pneumococcal conjugate vaccine (PCV7) in 2000, invasive disease from those seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) has nearly disappeared, but disease from non-PCV7 serotypes has been on the rise since at least 2004.

In 2006–2007, 5% of isolates from invasive pneumococcal disease in children younger than 5 years old contained serotype 22F, and 5% contained 33F, which promoted these isolates to candidates for the PCV15 vaccine (J. Infect. Dis. 2010;201: 32–41).

The most important serotype accounting for nearly half of invasive pneumococcal disease since introduction of the PCV7 vaccine – serotype 19A – was added to the 13-valent pneumococcal vaccine (PCV13) that was licensed in early 2010. The 200–2007 data showed that 47% of invasive pneumococcal infections in children under 5 years of age was due to serotype 19A. Other data show that perhaps half of 19A isolates are resistant to three or more classes of antibiotics.

The PCV13 vaccine (Prevnar 13, made by Wyeth Pharmaceuticals Inc. and marketed by Pfizer Inc.) also added serotypes 1, 3, 5, 6A, and 7F. “Serotypes 1 and 3 are very important causes of pneumonia, especially pneumonia with empyema. We don't see much serotype 5 in the United States, so it's not going to make much of an impact there,” Dr. Kaplan said.

The success of PCV7 stokes hopes that PCV13 could have an equally dramatic impact. “I think we're going to see a major decline in invasive disease due to adding these nonvaccine serotypes to the PCV13,” perhaps reducing the current numbers of invasive pneumococcal disease by 70%, he added.

The Advisory Committee on Immunization Practices (ACIP) and the Red Book by the American Academy of Pediatrics' Committee on Infectious Diseases recommend administering PCV13 routinely to children at 2 months of age and suggest a catch-up schedule for children with incomplete vaccination histories.

Centers for Disease Control and Prevention monitoring after introduction of the PCV7 vaccine showed a 70%–75% reduction in overall invasive pneumococcal disease, Dr. Kaplan said.

His institution is part of a coalition of eight children's hospitals that have been monitoring invasive pneumococcal disease since 1994, covering a surveillance population of around 19 million people. Cases of invasive pneumococcal disease decreased from an average of 400–500 cases per year before the PCV7 vaccine to a nadir of 100–200 cases per year in 2004, but the number has slowly crept up since then to 221 cases in 2009, he said (Pediatrics 2010;125:429-36).

As in CDC data, serotype 19A accounts for about half of invasive pneumococcal disease cases in the network's surveillance, he added. The network data also show that the most prominent type of infection before PCV7, bacteremia, fell from approximately 60% of cases to around 40% of cases post-PCV7. Pneumonia increased from 20% of cases to 30%, and the proportion of isolates associated with bacterial meningitis remained relatively steady, between 11% and 17%.

“In our multicenter study, cases of culture-proven pneumococcal pneumonia declined from 80–100 kids per year to about 40–50 cases/year in 2004, and have slowly climbed back up to more than 60 cases per year,” entirely due to serotypes not included in PCV7, Dr. Kaplan said.

Although PCV7 was associated with a modest decline in cases of acute otitis media and in the use of antibiotics to treat AOM, at least until 2004, multidrug-resistant serotype 19A is playing a larger role in AOM. “In our studies, 19A accounts for about 60% of pneumococcal isolates recovered from children who have draining ears, myringotomies,” and pressure equalization tubes, he said. “As a result, we're seeing an increasing number of kids with pneumococcal mastoiditis,” he added. Mastoiditis cases declined from around 5–10 cases per year before PCV7 to 3–4 cases per year, but have totaled 15–25 cases per year in the past few years. The main serotype associated with mastoiditis is 19A, but serotype 3 also plays an important role, he said. Both are included in PCV13.

Dr. Kaplan has received grants from Pfizer Inc. and Sanofi Pasteur for investigator-initiated studies, and is a member of pediatric advisory committees for Pfizer, Novartis, and Sanofi Pasteur. He said he has received honoraria from Pfizer, Novartis, GlaxoSmithKline, and Sanofi Pasteur.

'We can't keep adding new serotypes. There are 92 serotypes.'

Source DR. KAPLAN

SAN FRANCISCO — Parents may think they know when their child has an acute ear infection, but they don't.

That's the implication of a study of children aged 6–35 months that showed parents' reasons for suspecting acute otitis media (AOM), symptoms, and symptom scores could not differentiate 237 children with AOM from 232 who had respiratory tract infection without AOM. Only when tympanic-membrane examination was added to these clues could the diagnosis be made (Pediatrics 2010;125: e1154-61).

“For me, this study has quite a lot of meaning,” Dr. Ellen R. Wald said at the meeting. “Parental diagnosis of acute otitis media” is not reliable. “We shouldn't let the presence of those historical items persuade us” to accept a presumed diagnosis.

The diagnosis of AOM relies heavily on accurate otoscopy, said Dr. Wald, professor and chair of pediatrics at the University of Wisconsin, Madison.

She did not participate in the Finnish study, in which parents completed structured questionnaires on the occurrence, duration, and severity of symptoms before otoscopic examination of the child.

The reasons that parents thought a child might have an ear infection did not differ significantly between groups. In children with and without AOM, respectively, parental suspicion was raised by restless sleep in 28% and 29%, ear pain in 13% and 9%, ear rubbing in 10% and 18%, severe or prolonged rhinitis or cough in 9% and 7%, and irritability in 17% and 19%.

Fever also did not differentiate between the two groups.

Otoscopy also is essential to differentiate AOM from OM with effusion, Dr. Wald added. AOM results from a bacterial infection, and antibiotic therapy may help. OM with effusion is a sterile, nonbacterial inflammatory state that resolves spontaneously, and antibiotic therapy is neither appropriate nor beneficial. OM with effusion causes hearing loss, which is a confounder for AOM, she said.

Dr. Wald said she has no relevant conflicts of interest.

SAN FRANCISCO — Parents may think they know when their child has an acute ear infection, but they don't.

That's the implication of a study of children aged 6–35 months that showed parents' reasons for suspecting acute otitis media (AOM), symptoms, and symptom scores could not differentiate 237 children with AOM from 232 who had respiratory tract infection without AOM. Only when tympanic-membrane examination was added to these clues could the diagnosis be made (Pediatrics 2010;125: e1154-61).

“For me, this study has quite a lot of meaning,” Dr. Ellen R. Wald said at the meeting. “Parental diagnosis of acute otitis media” is not reliable. “We shouldn't let the presence of those historical items persuade us” to accept a presumed diagnosis.

The diagnosis of AOM relies heavily on accurate otoscopy, said Dr. Wald, professor and chair of pediatrics at the University of Wisconsin, Madison.

She did not participate in the Finnish study, in which parents completed structured questionnaires on the occurrence, duration, and severity of symptoms before otoscopic examination of the child.

The reasons that parents thought a child might have an ear infection did not differ significantly between groups. In children with and without AOM, respectively, parental suspicion was raised by restless sleep in 28% and 29%, ear pain in 13% and 9%, ear rubbing in 10% and 18%, severe or prolonged rhinitis or cough in 9% and 7%, and irritability in 17% and 19%.

Fever also did not differentiate between the two groups.

Otoscopy also is essential to differentiate AOM from OM with effusion, Dr. Wald added. AOM results from a bacterial infection, and antibiotic therapy may help. OM with effusion is a sterile, nonbacterial inflammatory state that resolves spontaneously, and antibiotic therapy is neither appropriate nor beneficial. OM with effusion causes hearing loss, which is a confounder for AOM, she said.

Dr. Wald said she has no relevant conflicts of interest.

SAN FRANCISCO — Parents may think they know when their child has an acute ear infection, but they don't.

That's the implication of a study of children aged 6–35 months that showed parents' reasons for suspecting acute otitis media (AOM), symptoms, and symptom scores could not differentiate 237 children with AOM from 232 who had respiratory tract infection without AOM. Only when tympanic-membrane examination was added to these clues could the diagnosis be made (Pediatrics 2010;125: e1154-61).

“For me, this study has quite a lot of meaning,” Dr. Ellen R. Wald said at the meeting. “Parental diagnosis of acute otitis media” is not reliable. “We shouldn't let the presence of those historical items persuade us” to accept a presumed diagnosis.

The diagnosis of AOM relies heavily on accurate otoscopy, said Dr. Wald, professor and chair of pediatrics at the University of Wisconsin, Madison.

She did not participate in the Finnish study, in which parents completed structured questionnaires on the occurrence, duration, and severity of symptoms before otoscopic examination of the child.

The reasons that parents thought a child might have an ear infection did not differ significantly between groups. In children with and without AOM, respectively, parental suspicion was raised by restless sleep in 28% and 29%, ear pain in 13% and 9%, ear rubbing in 10% and 18%, severe or prolonged rhinitis or cough in 9% and 7%, and irritability in 17% and 19%.

Fever also did not differentiate between the two groups.

Otoscopy also is essential to differentiate AOM from OM with effusion, Dr. Wald added. AOM results from a bacterial infection, and antibiotic therapy may help. OM with effusion is a sterile, nonbacterial inflammatory state that resolves spontaneously, and antibiotic therapy is neither appropriate nor beneficial. OM with effusion causes hearing loss, which is a confounder for AOM, she said.

Dr. Wald said she has no relevant conflicts of interest.

SAN FRANCISCO — Antibiotic therapy for acute otitis media may be more effective than some physicians think, a study has shown.

Some new data add to controversy that has been stirring since 2004 clinical practice guidelines from the American Academy of Pediatrics and the American Academy of Family Physicians included the option of watchful waiting in some children with uncomplicated acute otitis media (Pediatrics 2004;113:1451-65).

Support for management by observation came primarily from the desire to avoid escalation of antibiotic resistance and from the results of several meta-analyses suggesting that antibiotics are only modestly beneficial in treating acute otitis media, compared with placebo.

“Many of the meta-analyses had substantial flaws,” and included studies that used weak definitions of acute otitis media and so classified some children who had otitis media with effusion as having acute otitis media, Dr. Ellen R. Wald said at the meeting. Because antibiotic therapy does not help otitis media with effusion, it's no wonder that antibiotics barely outperformed placebo in these studies, said Dr. Wald, professor and chair of pediatrics at the University of Wisconsin, Madison.

She described a new study led Dr. Alejandro Hoberman, chief of pediatrics at Children's Hospital, Philadelphia, that found significantly lower rates of treatment failure in children treated with amoxicillin-clavulanate, compared with placebo, she added. The results have been submitted for publication.

The study randomized 291 children aged 6–23 months with confirmed acute otitis media to treatment with the antibiotics or placebo for 10 days, with follow-up on days 4/5, days 10/12, and days 21/25. Patients with clinical failure to first-round therapy received amoxicillin and cefixime.

The amoxicillin-clavulanate treatment failed at or before days 4/5 in 4% of patients, compared with a 23% clinical failure rate in the placebo group (P less than .001). Clinical failure rates at or before days 10–12 were 16% in the amoxicillin-clavulanate group and 51% in the placebo group (P less than .001).

These differences are “more dramatic than in previously reported trials,” Dr. Wald said. For children aged 6–23 months who have acute otitis media, treatment with amoxicillin-clavulanate for 10 days provides measurable short-term benefit, she said.

In a separate study by other investigators, surveys completed by 1,114 physicians found no significant increase in the proportion who managed acute otitis media without antibiotics after the guidelines (16%), compared with before the guidelines (11%), she added (Pediatrics 2010 [doi:10.1542/peds.2009–1115]).

Dr. Wald said she had no relevant conflicts of interest.

These differences are 'more dramatic than in previously reported trials.'

Source DR. WALD

SAN FRANCISCO — Antibiotic therapy for acute otitis media may be more effective than some physicians think, a study has shown.

Some new data add to controversy that has been stirring since 2004 clinical practice guidelines from the American Academy of Pediatrics and the American Academy of Family Physicians included the option of watchful waiting in some children with uncomplicated acute otitis media (Pediatrics 2004;113:1451-65).

Support for management by observation came primarily from the desire to avoid escalation of antibiotic resistance and from the results of several meta-analyses suggesting that antibiotics are only modestly beneficial in treating acute otitis media, compared with placebo.

“Many of the meta-analyses had substantial flaws,” and included studies that used weak definitions of acute otitis media and so classified some children who had otitis media with effusion as having acute otitis media, Dr. Ellen R. Wald said at the meeting. Because antibiotic therapy does not help otitis media with effusion, it's no wonder that antibiotics barely outperformed placebo in these studies, said Dr. Wald, professor and chair of pediatrics at the University of Wisconsin, Madison.

She described a new study led Dr. Alejandro Hoberman, chief of pediatrics at Children's Hospital, Philadelphia, that found significantly lower rates of treatment failure in children treated with amoxicillin-clavulanate, compared with placebo, she added. The results have been submitted for publication.

The study randomized 291 children aged 6–23 months with confirmed acute otitis media to treatment with the antibiotics or placebo for 10 days, with follow-up on days 4/5, days 10/12, and days 21/25. Patients with clinical failure to first-round therapy received amoxicillin and cefixime.

The amoxicillin-clavulanate treatment failed at or before days 4/5 in 4% of patients, compared with a 23% clinical failure rate in the placebo group (P less than .001). Clinical failure rates at or before days 10–12 were 16% in the amoxicillin-clavulanate group and 51% in the placebo group (P less than .001).

These differences are “more dramatic than in previously reported trials,” Dr. Wald said. For children aged 6–23 months who have acute otitis media, treatment with amoxicillin-clavulanate for 10 days provides measurable short-term benefit, she said.

In a separate study by other investigators, surveys completed by 1,114 physicians found no significant increase in the proportion who managed acute otitis media without antibiotics after the guidelines (16%), compared with before the guidelines (11%), she added (Pediatrics 2010 [doi:10.1542/peds.2009–1115]).

Dr. Wald said she had no relevant conflicts of interest.

These differences are 'more dramatic than in previously reported trials.'

Source DR. WALD

SAN FRANCISCO — Antibiotic therapy for acute otitis media may be more effective than some physicians think, a study has shown.

Some new data add to controversy that has been stirring since 2004 clinical practice guidelines from the American Academy of Pediatrics and the American Academy of Family Physicians included the option of watchful waiting in some children with uncomplicated acute otitis media (Pediatrics 2004;113:1451-65).

Support for management by observation came primarily from the desire to avoid escalation of antibiotic resistance and from the results of several meta-analyses suggesting that antibiotics are only modestly beneficial in treating acute otitis media, compared with placebo.

“Many of the meta-analyses had substantial flaws,” and included studies that used weak definitions of acute otitis media and so classified some children who had otitis media with effusion as having acute otitis media, Dr. Ellen R. Wald said at the meeting. Because antibiotic therapy does not help otitis media with effusion, it's no wonder that antibiotics barely outperformed placebo in these studies, said Dr. Wald, professor and chair of pediatrics at the University of Wisconsin, Madison.

She described a new study led Dr. Alejandro Hoberman, chief of pediatrics at Children's Hospital, Philadelphia, that found significantly lower rates of treatment failure in children treated with amoxicillin-clavulanate, compared with placebo, she added. The results have been submitted for publication.

The study randomized 291 children aged 6–23 months with confirmed acute otitis media to treatment with the antibiotics or placebo for 10 days, with follow-up on days 4/5, days 10/12, and days 21/25. Patients with clinical failure to first-round therapy received amoxicillin and cefixime.

The amoxicillin-clavulanate treatment failed at or before days 4/5 in 4% of patients, compared with a 23% clinical failure rate in the placebo group (P less than .001). Clinical failure rates at or before days 10–12 were 16% in the amoxicillin-clavulanate group and 51% in the placebo group (P less than .001).

These differences are “more dramatic than in previously reported trials,” Dr. Wald said. For children aged 6–23 months who have acute otitis media, treatment with amoxicillin-clavulanate for 10 days provides measurable short-term benefit, she said.

In a separate study by other investigators, surveys completed by 1,114 physicians found no significant increase in the proportion who managed acute otitis media without antibiotics after the guidelines (16%), compared with before the guidelines (11%), she added (Pediatrics 2010 [doi:10.1542/peds.2009–1115]).

Dr. Wald said she had no relevant conflicts of interest.

These differences are 'more dramatic than in previously reported trials.'

Source DR. WALD

SAN FRANCISCO — Beginning in January 2011, federal agencies will identify and test various models of paying for health services in a patient-centered medical home.

The Centers for Medicaid and Medicare Services (CMS) is charged by the 2010 Affordable Care Act to test innovative payment and service delivery models to reduce program spending while promoting quality care.

The health care reform act specifies that models of care be chosen based on their ability to improve the coordination, quality, and efficiency of services, Dr. Xavier Sevilla said at the meeting.

The patient-centered medical home is one of the models to be tested, and the challenge lies in figuring out payment methods that will enable physician practices to provide comprehensive primary care that is accessible, continuous, family centered, coordinated with other caregivers, compassionate, and culturally effective, he said.

“I don't think we're going to see the private payers move until CMS does,” added Dr. Sevilla, chief of pediatrics for Manatee County Rural Health Services, Bradenton, Fla.

He serves as the Academy's representative to the National Committee for Quality Assurance Advisory Panel on the Physician Practice Connections Patient-Centered Medical Home.

Today, however, the most common “resolution kit” available to physicians trying to resolve payment issues for the different kinds of work they do in patient-centered medical homes is a homemade sign with a circle around the words “Bang head here,” he joked.

Current payment systems encourage quantity over quality and reward procedures over evaluation and management of patients, he said. Payments are made only for services administered by clinicians and cover only services performed in the office setting when the patient is present, which ignores care coordination and nonoffice communications with patients, such as via e-mail.

The ideal payment system would incentivize care coordination and improving the quality of care. It would support the transformation of practices from individual care to population-based care, from physician-provided care to team-based care, and from episodic care to continuous care, Dr. Sevilla said.

He described several payment proposals that could be tested in the demonstration programs, some of which already are underway in pilot projects.

One model retains existing fee-for-service contracts and adds a per-member-per-month case-management fee and pay-for-performance reimbursements using nationally validated quality measures of process and outcome. A Colorado-based pilot is testing this model in a Multistate Patient Centered Medical Home program.

This model could improve office efficiency and access, depending on the pay-for-performance measures, Dr. Sevilla said. The management fee supports non–office communications and non–physician care, and allows the practice team to concentrate on the whole practice population.

Fundamental practice changes are unlikely unless the management fee and payments for performance are large enough, he added. The management fee could allow small practices to join together to share costs.

This payment model could be relatively easy to implement, because it simply adds to the existing payment system.

Another model also would keep the fee-for-service system but develop new CPT codes for medical home activities that currently are not reimbursed. These may include phone and e-mail consultations, after-hours services, phone calls with specialists, and more.

Currently, Blue Cross and Blue Shield of Michigan pays for practice-based care management, and Horizon Blue Cross and Blue Shield of New Jersey pays for phone calls to patients and specialists.

This model does not incentivize improving the quality of care or population-based care, however, and the new CPT codes would need to include tasks performed by non–physicians to support a team approach.

Many of the CPT codes needed for patient-centered medical homes exist, but are not recognized by most payers, including CMS.

Adding more codes to the 8,000-code CPT system would increase complexity, and costs may not decrease if the codes are over-used, Dr. Sevilla said.

A third payment model would provide monthly comprehensive payments based on yearly per-patient risk-adjusted calculations of per-patient–per-month reimbursements. In addition, practices would receive up to 25% risk-adjusted bonuses for achieving goals in quality, cost, and patient experience.

“To make this work, we'd need a validated actuarial model that predicts a patient's need for primary care and that provides a relative risk based on demographics and billing diagnoses,” he said.

The guaranteed monthly payment would cover the multidisciplinary team, technological infrastructure, and non–face-to-face communications.

“This would require a major culture change by payors and physicians,” Dr. Sevilla noted. Payors would need to make up-front investments and change their basis for payment.

The Capital District Physicians Health Plan in Albany, N.Y., is trying this payment model, he added.

While demonstration projects test the various practice and payment models, physicians can help move the medical system toward patient-centered medical homes by advocating for payment methods that support the medical home, and participating in one of the demonstrations of new payment methods, Dr. Sevilla said.

“Familiarize yourself with opportunities to participate in payment demonstration projects” and use what you learn when negotiating contracts with payers, he suggested. “I think this is really coming to a practice near you pretty soon.”

Dr. Sevilla said he had no relevant conflicts of interest.

SAN FRANCISCO — Beginning in January 2011, federal agencies will identify and test various models of paying for health services in a patient-centered medical home.

The Centers for Medicaid and Medicare Services (CMS) is charged by the 2010 Affordable Care Act to test innovative payment and service delivery models to reduce program spending while promoting quality care.

The health care reform act specifies that models of care be chosen based on their ability to improve the coordination, quality, and efficiency of services, Dr. Xavier Sevilla said at the meeting.

The patient-centered medical home is one of the models to be tested, and the challenge lies in figuring out payment methods that will enable physician practices to provide comprehensive primary care that is accessible, continuous, family centered, coordinated with other caregivers, compassionate, and culturally effective, he said.

“I don't think we're going to see the private payers move until CMS does,” added Dr. Sevilla, chief of pediatrics for Manatee County Rural Health Services, Bradenton, Fla.

He serves as the Academy's representative to the National Committee for Quality Assurance Advisory Panel on the Physician Practice Connections Patient-Centered Medical Home.

Today, however, the most common “resolution kit” available to physicians trying to resolve payment issues for the different kinds of work they do in patient-centered medical homes is a homemade sign with a circle around the words “Bang head here,” he joked.

Current payment systems encourage quantity over quality and reward procedures over evaluation and management of patients, he said. Payments are made only for services administered by clinicians and cover only services performed in the office setting when the patient is present, which ignores care coordination and nonoffice communications with patients, such as via e-mail.

The ideal payment system would incentivize care coordination and improving the quality of care. It would support the transformation of practices from individual care to population-based care, from physician-provided care to team-based care, and from episodic care to continuous care, Dr. Sevilla said.

He described several payment proposals that could be tested in the demonstration programs, some of which already are underway in pilot projects.

One model retains existing fee-for-service contracts and adds a per-member-per-month case-management fee and pay-for-performance reimbursements using nationally validated quality measures of process and outcome. A Colorado-based pilot is testing this model in a Multistate Patient Centered Medical Home program.

This model could improve office efficiency and access, depending on the pay-for-performance measures, Dr. Sevilla said. The management fee supports non–office communications and non–physician care, and allows the practice team to concentrate on the whole practice population.

Fundamental practice changes are unlikely unless the management fee and payments for performance are large enough, he added. The management fee could allow small practices to join together to share costs.

This payment model could be relatively easy to implement, because it simply adds to the existing payment system.

Another model also would keep the fee-for-service system but develop new CPT codes for medical home activities that currently are not reimbursed. These may include phone and e-mail consultations, after-hours services, phone calls with specialists, and more.

Currently, Blue Cross and Blue Shield of Michigan pays for practice-based care management, and Horizon Blue Cross and Blue Shield of New Jersey pays for phone calls to patients and specialists.

This model does not incentivize improving the quality of care or population-based care, however, and the new CPT codes would need to include tasks performed by non–physicians to support a team approach.

Many of the CPT codes needed for patient-centered medical homes exist, but are not recognized by most payers, including CMS.

Adding more codes to the 8,000-code CPT system would increase complexity, and costs may not decrease if the codes are over-used, Dr. Sevilla said.

A third payment model would provide monthly comprehensive payments based on yearly per-patient risk-adjusted calculations of per-patient–per-month reimbursements. In addition, practices would receive up to 25% risk-adjusted bonuses for achieving goals in quality, cost, and patient experience.

“To make this work, we'd need a validated actuarial model that predicts a patient's need for primary care and that provides a relative risk based on demographics and billing diagnoses,” he said.

The guaranteed monthly payment would cover the multidisciplinary team, technological infrastructure, and non–face-to-face communications.

“This would require a major culture change by payors and physicians,” Dr. Sevilla noted. Payors would need to make up-front investments and change their basis for payment.

The Capital District Physicians Health Plan in Albany, N.Y., is trying this payment model, he added.

While demonstration projects test the various practice and payment models, physicians can help move the medical system toward patient-centered medical homes by advocating for payment methods that support the medical home, and participating in one of the demonstrations of new payment methods, Dr. Sevilla said.

“Familiarize yourself with opportunities to participate in payment demonstration projects” and use what you learn when negotiating contracts with payers, he suggested. “I think this is really coming to a practice near you pretty soon.”

Dr. Sevilla said he had no relevant conflicts of interest.

SAN FRANCISCO — Beginning in January 2011, federal agencies will identify and test various models of paying for health services in a patient-centered medical home.

The Centers for Medicaid and Medicare Services (CMS) is charged by the 2010 Affordable Care Act to test innovative payment and service delivery models to reduce program spending while promoting quality care.

The health care reform act specifies that models of care be chosen based on their ability to improve the coordination, quality, and efficiency of services, Dr. Xavier Sevilla said at the meeting.

The patient-centered medical home is one of the models to be tested, and the challenge lies in figuring out payment methods that will enable physician practices to provide comprehensive primary care that is accessible, continuous, family centered, coordinated with other caregivers, compassionate, and culturally effective, he said.

“I don't think we're going to see the private payers move until CMS does,” added Dr. Sevilla, chief of pediatrics for Manatee County Rural Health Services, Bradenton, Fla.

He serves as the Academy's representative to the National Committee for Quality Assurance Advisory Panel on the Physician Practice Connections Patient-Centered Medical Home.

Today, however, the most common “resolution kit” available to physicians trying to resolve payment issues for the different kinds of work they do in patient-centered medical homes is a homemade sign with a circle around the words “Bang head here,” he joked.

Current payment systems encourage quantity over quality and reward procedures over evaluation and management of patients, he said. Payments are made only for services administered by clinicians and cover only services performed in the office setting when the patient is present, which ignores care coordination and nonoffice communications with patients, such as via e-mail.

The ideal payment system would incentivize care coordination and improving the quality of care. It would support the transformation of practices from individual care to population-based care, from physician-provided care to team-based care, and from episodic care to continuous care, Dr. Sevilla said.

He described several payment proposals that could be tested in the demonstration programs, some of which already are underway in pilot projects.

One model retains existing fee-for-service contracts and adds a per-member-per-month case-management fee and pay-for-performance reimbursements using nationally validated quality measures of process and outcome. A Colorado-based pilot is testing this model in a Multistate Patient Centered Medical Home program.

This model could improve office efficiency and access, depending on the pay-for-performance measures, Dr. Sevilla said. The management fee supports non–office communications and non–physician care, and allows the practice team to concentrate on the whole practice population.

Fundamental practice changes are unlikely unless the management fee and payments for performance are large enough, he added. The management fee could allow small practices to join together to share costs.

This payment model could be relatively easy to implement, because it simply adds to the existing payment system.

Another model also would keep the fee-for-service system but develop new CPT codes for medical home activities that currently are not reimbursed. These may include phone and e-mail consultations, after-hours services, phone calls with specialists, and more.

Currently, Blue Cross and Blue Shield of Michigan pays for practice-based care management, and Horizon Blue Cross and Blue Shield of New Jersey pays for phone calls to patients and specialists.

This model does not incentivize improving the quality of care or population-based care, however, and the new CPT codes would need to include tasks performed by non–physicians to support a team approach.

Many of the CPT codes needed for patient-centered medical homes exist, but are not recognized by most payers, including CMS.

Adding more codes to the 8,000-code CPT system would increase complexity, and costs may not decrease if the codes are over-used, Dr. Sevilla said.

A third payment model would provide monthly comprehensive payments based on yearly per-patient risk-adjusted calculations of per-patient–per-month reimbursements. In addition, practices would receive up to 25% risk-adjusted bonuses for achieving goals in quality, cost, and patient experience.

“To make this work, we'd need a validated actuarial model that predicts a patient's need for primary care and that provides a relative risk based on demographics and billing diagnoses,” he said.

The guaranteed monthly payment would cover the multidisciplinary team, technological infrastructure, and non–face-to-face communications.

“This would require a major culture change by payors and physicians,” Dr. Sevilla noted. Payors would need to make up-front investments and change their basis for payment.

The Capital District Physicians Health Plan in Albany, N.Y., is trying this payment model, he added.

While demonstration projects test the various practice and payment models, physicians can help move the medical system toward patient-centered medical homes by advocating for payment methods that support the medical home, and participating in one of the demonstrations of new payment methods, Dr. Sevilla said.

“Familiarize yourself with opportunities to participate in payment demonstration projects” and use what you learn when negotiating contracts with payers, he suggested. “I think this is really coming to a practice near you pretty soon.”

Dr. Sevilla said he had no relevant conflicts of interest.

SAN FRANCISCO — For best outcomes in acne patients, address specific factors that affect the likelihood of adherence for an individual and incorporate that information into the larger treatment plan, advises Dr. Christina Kim, a dermatologist at the University of California, Los Angeles.

“On the initial visit, it's worthwhile to spend a little bit of extra time on thinking about patient adherence.” In medicine as a whole, 20%-50% of patients do not take medications as directed. “That number is probably much higher in dermatology, as topical therapies are notorious for their lack of adherence or compliance,” Dr. Kim said at the annual meeting of the Pacific Dermatologic Association.

To assist adherence, consider cost, patient preferences, and convenience. Choose medications that the patient can afford. “Once-daily formulations are more user friendly. If there's an inconvenience aspect to a therapy – like having to take a [product] out of the refrigerator when it's time for application – the likelihood of adherence decreases.”

Patients expect to get better fast – usually within 4-6 weeks – so it's important to explain that acne is a chronic disease, and to describe the time frame for treatment response.

“Usually I tell my patients that my strategy is to improve their acne in the next couple of months with pills. Then they will be on creams for many months after that, to keep their skin clear. Their acne will not go away for several years, and only time will tell when it will resolve,” Dr. Kim said.

If you don't manage patient expectations, they will move on to another physician when the acne doesn't improve as quickly as they want.

“If patients feel they're getting better, they're much more likely to continue treatment. Studies show if a patient is pleased with the physician, if they know that you care, that you are working to improve their disease, they're also more likely to use the treatment that you recommend,” she said.

Discuss with patients not only how to apply their acne medication, but what to do and not do in their non-acne skin care, she added. “If they're using everything under the sun that's over the counter, their skin is going to get irritated, they're not going to continue with their treatment, and adherence will go down.”

Schedule the first follow-up visit soon after the initial visit, she advised. “Even though you don't expect your therapeutics to take effect sometimes for several months, it's worthwhile to see your patient back in 4-6 weeks to see if they are using the products, to see if there are any side effects or any barriers to their use.”

At each visit, ask about adherence, using open-ended, nonjudgmental questions that help establish trust and confidence in your patient. “I usually ask, 'How did you find the treatment? Have you been able to do it? Do you find it bothersome? What about the treatment do you not like? What about the treatment do you like?'” Dr. Kim said.

“It seems obvious, but I think it's something we don't always do. It turns out that when you ask, either verbally or in questionnaires, patients will be very open with you.”

You may discover, for example, that the patient used the samples you provided, but hated the product and didn't buy any more. “That's why their skin didn't get better. They weren't using the treatment,” she said.

Dr. Kim said she had no financial conflicts of interest.

In medicine as a whole, 20%–50% of patients do not take medications as directed.

Source DR. KIM

SAN FRANCISCO — For best outcomes in acne patients, address specific factors that affect the likelihood of adherence for an individual and incorporate that information into the larger treatment plan, advises Dr. Christina Kim, a dermatologist at the University of California, Los Angeles.

“On the initial visit, it's worthwhile to spend a little bit of extra time on thinking about patient adherence.” In medicine as a whole, 20%-50% of patients do not take medications as directed. “That number is probably much higher in dermatology, as topical therapies are notorious for their lack of adherence or compliance,” Dr. Kim said at the annual meeting of the Pacific Dermatologic Association.

To assist adherence, consider cost, patient preferences, and convenience. Choose medications that the patient can afford. “Once-daily formulations are more user friendly. If there's an inconvenience aspect to a therapy – like having to take a [product] out of the refrigerator when it's time for application – the likelihood of adherence decreases.”

Patients expect to get better fast – usually within 4-6 weeks – so it's important to explain that acne is a chronic disease, and to describe the time frame for treatment response.

“Usually I tell my patients that my strategy is to improve their acne in the next couple of months with pills. Then they will be on creams for many months after that, to keep their skin clear. Their acne will not go away for several years, and only time will tell when it will resolve,” Dr. Kim said.

If you don't manage patient expectations, they will move on to another physician when the acne doesn't improve as quickly as they want.

“If patients feel they're getting better, they're much more likely to continue treatment. Studies show if a patient is pleased with the physician, if they know that you care, that you are working to improve their disease, they're also more likely to use the treatment that you recommend,” she said.

Discuss with patients not only how to apply their acne medication, but what to do and not do in their non-acne skin care, she added. “If they're using everything under the sun that's over the counter, their skin is going to get irritated, they're not going to continue with their treatment, and adherence will go down.”

Schedule the first follow-up visit soon after the initial visit, she advised. “Even though you don't expect your therapeutics to take effect sometimes for several months, it's worthwhile to see your patient back in 4-6 weeks to see if they are using the products, to see if there are any side effects or any barriers to their use.”

At each visit, ask about adherence, using open-ended, nonjudgmental questions that help establish trust and confidence in your patient. “I usually ask, 'How did you find the treatment? Have you been able to do it? Do you find it bothersome? What about the treatment do you not like? What about the treatment do you like?'” Dr. Kim said.

“It seems obvious, but I think it's something we don't always do. It turns out that when you ask, either verbally or in questionnaires, patients will be very open with you.”

You may discover, for example, that the patient used the samples you provided, but hated the product and didn't buy any more. “That's why their skin didn't get better. They weren't using the treatment,” she said.

Dr. Kim said she had no financial conflicts of interest.

In medicine as a whole, 20%–50% of patients do not take medications as directed.

Source DR. KIM

SAN FRANCISCO — For best outcomes in acne patients, address specific factors that affect the likelihood of adherence for an individual and incorporate that information into the larger treatment plan, advises Dr. Christina Kim, a dermatologist at the University of California, Los Angeles.

“On the initial visit, it's worthwhile to spend a little bit of extra time on thinking about patient adherence.” In medicine as a whole, 20%-50% of patients do not take medications as directed. “That number is probably much higher in dermatology, as topical therapies are notorious for their lack of adherence or compliance,” Dr. Kim said at the annual meeting of the Pacific Dermatologic Association.

To assist adherence, consider cost, patient preferences, and convenience. Choose medications that the patient can afford. “Once-daily formulations are more user friendly. If there's an inconvenience aspect to a therapy – like having to take a [product] out of the refrigerator when it's time for application – the likelihood of adherence decreases.”

Patients expect to get better fast – usually within 4-6 weeks – so it's important to explain that acne is a chronic disease, and to describe the time frame for treatment response.

“Usually I tell my patients that my strategy is to improve their acne in the next couple of months with pills. Then they will be on creams for many months after that, to keep their skin clear. Their acne will not go away for several years, and only time will tell when it will resolve,” Dr. Kim said.

If you don't manage patient expectations, they will move on to another physician when the acne doesn't improve as quickly as they want.

“If patients feel they're getting better, they're much more likely to continue treatment. Studies show if a patient is pleased with the physician, if they know that you care, that you are working to improve their disease, they're also more likely to use the treatment that you recommend,” she said.

Discuss with patients not only how to apply their acne medication, but what to do and not do in their non-acne skin care, she added. “If they're using everything under the sun that's over the counter, their skin is going to get irritated, they're not going to continue with their treatment, and adherence will go down.”

Schedule the first follow-up visit soon after the initial visit, she advised. “Even though you don't expect your therapeutics to take effect sometimes for several months, it's worthwhile to see your patient back in 4-6 weeks to see if they are using the products, to see if there are any side effects or any barriers to their use.”

At each visit, ask about adherence, using open-ended, nonjudgmental questions that help establish trust and confidence in your patient. “I usually ask, 'How did you find the treatment? Have you been able to do it? Do you find it bothersome? What about the treatment do you not like? What about the treatment do you like?'” Dr. Kim said.

“It seems obvious, but I think it's something we don't always do. It turns out that when you ask, either verbally or in questionnaires, patients will be very open with you.”

You may discover, for example, that the patient used the samples you provided, but hated the product and didn't buy any more. “That's why their skin didn't get better. They weren't using the treatment,” she said.

Dr. Kim said she had no financial conflicts of interest.

In medicine as a whole, 20%–50% of patients do not take medications as directed.

Source DR. KIM

SAN FRANCISCO — Looking for signs of intimate partner violence between parents of pediatric patients may or may not help the parents, but the effects of that violence on children are so profound that physicians must ask about it, a clinical report from the American Academy of Pediatrics concludes.

The lead author of the report, Dr. Jonathan D. Thackeray, highlighted it in a plenary session at the academy's national meeting because the recommendations didn't get the attention they deserved when published earlier this year, he said (Pediatrics 2010;125: 1094-100).

Approximately 29% of U.S. children in dual-parent households (15.5 million children) were exposed to intimate partner violence in the previous year, and 13% of children (7 million) were in households with severe intimate partner violence, results of a 2006 study suggest (J. Fam. Psychol. 2006;20:137-42).

Those findings probably underestimate the problem because that survey did not include children living with single parents, grandparents, or same-sex parents, noted Dr. Thackeray of Ohio State University. “If you look for intimate partner violence, you will find it,” he said.

There's overwhelming evidence that children exposed to intimate partner violence face increased risk for child maltreatment and medical, behavioral, and mental health problems in both the short and long terms, added Dr. Thackeray, clinical director of the Child Assessment Center, Center for Child and Family Advocacy at Nationwide Children's Hospital, Columbus, Ohio.

When either child maltreatment or intimate partner violence is present in a family, the other will be present in 30%-60% of cases, data suggest. When intimate partner violence affects a parent, the child's risk of neglect or emotional abuse doubles and the risk of physical abuse more than triples. The violence also may injure the child.

In the long run, adults who report childhood exposure to intimate partner violence in the family had a sixfold increased risk for emotional abuse or substance abuse, a fivefold increased risk for physical neglect or physical abuse, and a threefold higher risk for sexual abuse or incarceration of family members (Violence Vict. 2002;17:3-17). The more often they witnessed intimate partner violence as a child, the more likely they were as adults to report alcoholism, illicit or IV drug use, or depression.

The academy's clinical report, produced by members of its Committee on Child Abuse and Neglect and Committee on Injury, Violence, and Poison Prevention, echoes endorsements of intimate partner violence screening by most major medical organizations.

These contrast somewhat with guidelines by government bodies concluding that there's insufficient evidence to recommend for or against routine screening of women for intimate partner violence. Both the U.S. Preventive Services Task Force (Ann. Fam. Med. 2004;2:156-60) and the Canadian Task Force on Preventive Health Care (CMAJ 2003;169:582-4) concluded that there's insufficient evidence to recommend for or against routine screening of women for intimate partner violence.

Various studies report finding intimate partner violence affecting 15%-41% of women screened, but have not shown that screening and detection make a significant difference in the odds of the violence recurring That may be a sign that current interventions for women who screen positive for intimate partner violence are ineffective, Dr. Thackeray said.

The academy's clinical report recommends screening either verbally or through self-administered written assessment, and report offers resources and suggestions for referrals and safety plans that can be offered to parents dealing with intimate partner violence.

Dr. Thackeray said he has no pertinent conflicts of interest.

Children exposed to intimate partner violence face increased risk for child maltreatment.

Source DR. THACKERAY

How to Ask About Intimate Partner Violence

When further questioning about intimate partner violence seems warranted, clinicians can broach the topic by asking one of these questions, Dr. Thackeray and his associates suggest:

▸ “We all have disagreements at home. What happens when you and your partner disagree?”

“Is there shouting, pushing, or shoving? Does anyone get hurt?”

▸ “Has your partner ever threatened to hurt you or your children?”

▸ “Do you ever feel afraid of your partner?”

▸ “Has anyone forced you to have sex in the last few years?”

SAN FRANCISCO — Looking for signs of intimate partner violence between parents of pediatric patients may or may not help the parents, but the effects of that violence on children are so profound that physicians must ask about it, a clinical report from the American Academy of Pediatrics concludes.

The lead author of the report, Dr. Jonathan D. Thackeray, highlighted it in a plenary session at the academy's national meeting because the recommendations didn't get the attention they deserved when published earlier this year, he said (Pediatrics 2010;125: 1094-100).

Approximately 29% of U.S. children in dual-parent households (15.5 million children) were exposed to intimate partner violence in the previous year, and 13% of children (7 million) were in households with severe intimate partner violence, results of a 2006 study suggest (J. Fam. Psychol. 2006;20:137-42).

Those findings probably underestimate the problem because that survey did not include children living with single parents, grandparents, or same-sex parents, noted Dr. Thackeray of Ohio State University. “If you look for intimate partner violence, you will find it,” he said.

There's overwhelming evidence that children exposed to intimate partner violence face increased risk for child maltreatment and medical, behavioral, and mental health problems in both the short and long terms, added Dr. Thackeray, clinical director of the Child Assessment Center, Center for Child and Family Advocacy at Nationwide Children's Hospital, Columbus, Ohio.

When either child maltreatment or intimate partner violence is present in a family, the other will be present in 30%-60% of cases, data suggest. When intimate partner violence affects a parent, the child's risk of neglect or emotional abuse doubles and the risk of physical abuse more than triples. The violence also may injure the child.

In the long run, adults who report childhood exposure to intimate partner violence in the family had a sixfold increased risk for emotional abuse or substance abuse, a fivefold increased risk for physical neglect or physical abuse, and a threefold higher risk for sexual abuse or incarceration of family members (Violence Vict. 2002;17:3-17). The more often they witnessed intimate partner violence as a child, the more likely they were as adults to report alcoholism, illicit or IV drug use, or depression.

The academy's clinical report, produced by members of its Committee on Child Abuse and Neglect and Committee on Injury, Violence, and Poison Prevention, echoes endorsements of intimate partner violence screening by most major medical organizations.

These contrast somewhat with guidelines by government bodies concluding that there's insufficient evidence to recommend for or against routine screening of women for intimate partner violence. Both the U.S. Preventive Services Task Force (Ann. Fam. Med. 2004;2:156-60) and the Canadian Task Force on Preventive Health Care (CMAJ 2003;169:582-4) concluded that there's insufficient evidence to recommend for or against routine screening of women for intimate partner violence.

Various studies report finding intimate partner violence affecting 15%-41% of women screened, but have not shown that screening and detection make a significant difference in the odds of the violence recurring That may be a sign that current interventions for women who screen positive for intimate partner violence are ineffective, Dr. Thackeray said.

The academy's clinical report recommends screening either verbally or through self-administered written assessment, and report offers resources and suggestions for referrals and safety plans that can be offered to parents dealing with intimate partner violence.

Dr. Thackeray said he has no pertinent conflicts of interest.

Children exposed to intimate partner violence face increased risk for child maltreatment.

Source DR. THACKERAY

How to Ask About Intimate Partner Violence

When further questioning about intimate partner violence seems warranted, clinicians can broach the topic by asking one of these questions, Dr. Thackeray and his associates suggest:

▸ “We all have disagreements at home. What happens when you and your partner disagree?”

“Is there shouting, pushing, or shoving? Does anyone get hurt?”

▸ “Has your partner ever threatened to hurt you or your children?”

▸ “Do you ever feel afraid of your partner?”

▸ “Has anyone forced you to have sex in the last few years?”

SAN FRANCISCO — Looking for signs of intimate partner violence between parents of pediatric patients may or may not help the parents, but the effects of that violence on children are so profound that physicians must ask about it, a clinical report from the American Academy of Pediatrics concludes.

The lead author of the report, Dr. Jonathan D. Thackeray, highlighted it in a plenary session at the academy's national meeting because the recommendations didn't get the attention they deserved when published earlier this year, he said (Pediatrics 2010;125: 1094-100).

Approximately 29% of U.S. children in dual-parent households (15.5 million children) were exposed to intimate partner violence in the previous year, and 13% of children (7 million) were in households with severe intimate partner violence, results of a 2006 study suggest (J. Fam. Psychol. 2006;20:137-42).

Those findings probably underestimate the problem because that survey did not include children living with single parents, grandparents, or same-sex parents, noted Dr. Thackeray of Ohio State University. “If you look for intimate partner violence, you will find it,” he said.

There's overwhelming evidence that children exposed to intimate partner violence face increased risk for child maltreatment and medical, behavioral, and mental health problems in both the short and long terms, added Dr. Thackeray, clinical director of the Child Assessment Center, Center for Child and Family Advocacy at Nationwide Children's Hospital, Columbus, Ohio.

When either child maltreatment or intimate partner violence is present in a family, the other will be present in 30%-60% of cases, data suggest. When intimate partner violence affects a parent, the child's risk of neglect or emotional abuse doubles and the risk of physical abuse more than triples. The violence also may injure the child.

In the long run, adults who report childhood exposure to intimate partner violence in the family had a sixfold increased risk for emotional abuse or substance abuse, a fivefold increased risk for physical neglect or physical abuse, and a threefold higher risk for sexual abuse or incarceration of family members (Violence Vict. 2002;17:3-17). The more often they witnessed intimate partner violence as a child, the more likely they were as adults to report alcoholism, illicit or IV drug use, or depression.

The academy's clinical report, produced by members of its Committee on Child Abuse and Neglect and Committee on Injury, Violence, and Poison Prevention, echoes endorsements of intimate partner violence screening by most major medical organizations.

These contrast somewhat with guidelines by government bodies concluding that there's insufficient evidence to recommend for or against routine screening of women for intimate partner violence. Both the U.S. Preventive Services Task Force (Ann. Fam. Med. 2004;2:156-60) and the Canadian Task Force on Preventive Health Care (CMAJ 2003;169:582-4) concluded that there's insufficient evidence to recommend for or against routine screening of women for intimate partner violence.

Various studies report finding intimate partner violence affecting 15%-41% of women screened, but have not shown that screening and detection make a significant difference in the odds of the violence recurring That may be a sign that current interventions for women who screen positive for intimate partner violence are ineffective, Dr. Thackeray said.

The academy's clinical report recommends screening either verbally or through self-administered written assessment, and report offers resources and suggestions for referrals and safety plans that can be offered to parents dealing with intimate partner violence.

Dr. Thackeray said he has no pertinent conflicts of interest.

Children exposed to intimate partner violence face increased risk for child maltreatment.

Source DR. THACKERAY

How to Ask About Intimate Partner Violence

When further questioning about intimate partner violence seems warranted, clinicians can broach the topic by asking one of these questions, Dr. Thackeray and his associates suggest:

▸ “We all have disagreements at home. What happens when you and your partner disagree?”

“Is there shouting, pushing, or shoving? Does anyone get hurt?”

▸ “Has your partner ever threatened to hurt you or your children?”

▸ “Do you ever feel afraid of your partner?”

▸ “Has anyone forced you to have sex in the last few years?”

SAN FRANCISCO — Hard on the heels of approval of the 13-valent pneumococcal conjugate vaccine in early 2010, tests of a 15-valent pneumococcal conjugate vaccine are underway, and researchers are looking for new strategies beyond adding more and more pneumococcal serotypes to the vaccine.

“We can't keep adding new serotypes. There are 92 serotypes,” Dr. Sheldon L. Kaplan said at the meeting. One target may be a vaccine that's directed against noncapsular epitopes, suggested Dr. Kaplan, professor of pediatrics and head of the pediatric infectious diseases section at Baylor College of Medicine, Houston.

Meanwhile, the experimental 15-valent pneumococcal conjugate vaccine (PCV15) would add serotypes 22F and 33F – two of the five most common serotypes seen in invasive pneumococcal disease today. Since the introduction of the first 7-valent pneumococcal conjugate vaccine (PCV7) in 2000, invasive disease from those seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) has nearly disappeared, but disease from non-PCV7 serotypes has been on the rise since at least 2004.

In 2006-2007, 5% of isolates from invasive pneumococcal disease in children younger than 5 years old contained serotype 22F, and 5% contained 33F, which promoted these isolates to candidates for the PCV15 vaccine (J. Infect. Dis. 2010;201:32-41).

The most important serotype accounting for nearly half of invasive pneumococcal disease since introduction of the PCV7 vaccine – serotype 19A – was added to the 13-valent pneumococcal vaccine (PCV13) that was licensed in early 2010. The 2006-2007 data showed that 47% of invasive pneumococcal infections in children under 5 years of age was due to serotype 19A. Other data show that perhaps half of 19A isolates are resistant to three or more classes of antibiotics.

The PCV13 vaccine (Prevnar 13, made by Wyeth Pharmaceuticals Inc. and marketed by Pfizer Inc.) also added serotypes 1, 3, 5, 6A, and 7F. “Serotypes 1 and 3 are very important causes of pneumonia, especially pneumonia with empyema. We don't see much serotype 5 in the United States, so it's not going to make much of an impact there,” Dr. Kaplan said.

The success of PCV7 stokes hopes that PCV13 could have an equally dramatic impact. “I think we're going to see a major decline in invasive disease due to adding these nonvaccine serotypes to the PCV13,” perhaps reducing the current numbers of invasive pneumococcal disease by 70%, he added.

The Advisory Committee on Immunization Practices (ACIP) and the Red Book by the American Academy of Pediatrics' Committee on Infectious Diseases recommend administering PCV13 routinely to children at 2 months of age and suggest a catch-up schedule for children with incomplete vaccination histories.

Centers for Disease Control and Prevention monitoring after introduction of the PCV7 vaccine showed a 70%-75% reduction in overall invasive pneumococcal disease, Dr. Kaplan said.

His institution is part of a coalition of eight children's hospitals that have been monitoring invasive pneumococcal disease since 1994, covering a surveillance population of around 19 million people. Cases of invasive pneumococcal disease decreased from an average of 400-500 cases per year before the PCV7 vaccine to a nadir of 100-200 cases per year in 2004, but the number has slowly crept up since then to 221 cases in 2009, he said (Pediatrics 2010;125:429-36).

As in CDC data, serotype 19A accounts for about half of invasive pneumococcal disease cases in the network's surveillance, he added.

The network data also show that the most prominent type of infection before PCV7, bacteremia, fell from approximately 60% of cases to around 40% of cases post-PCV7. Pneumonia increased from 20% of cases to 30%, and the proportion of isolates associated with bacterial meningitis remained relatively steady, between 11% and 17%.

“In our multicenter study, cases of culture-proven pneumococcal pneumonia declined from 80-100 kids per year to about 40-50 cases/year in 2004, and have slowly climbed back up to more than 60 cases per year,” entirely due to serotypes not included in PCV7, Dr. Kaplan said. Other data have shown a rise in rates of complicated pneumonias, such as empyema, he added.

Although PCV7 was associated with a modest decline in cases of acute otitis media and in the use of antibiotics to treat AOM, at least until 2004, multidrug-resistant serotype 19A is playing a larger role in AOM. “In our studies, 19A accounts for about 60% of pneumococcal isolates recovered from children who have draining ears, myringotomies,” and pressure equalization tubes, he said.

“As a result, we're seeing an increasing number of kids with pneumococcal mastoiditis,” he added. Mastoiditis cases declined from around 5-10 cases per year before PCV7 to 3-4 cases per year, but have totaled 15-25 cases per year in the past few years.

Dr. Kaplan has received grants from Pfizer Inc. and Sanofi Pasteur for investigator-initiated studies, and is a member of pediatric advisory committees for Pfizer, Novartis, and Sanofi Pasteur. He said he has received honoraria from Pfizer, Novartis, GlaxoSmithKline, and Sanofi Pasteur.

'We can't keep adding new serotypes. There are 92 serotypes.'

Source DR. KAPLAN

SAN FRANCISCO — Hard on the heels of approval of the 13-valent pneumococcal conjugate vaccine in early 2010, tests of a 15-valent pneumococcal conjugate vaccine are underway, and researchers are looking for new strategies beyond adding more and more pneumococcal serotypes to the vaccine.

“We can't keep adding new serotypes. There are 92 serotypes,” Dr. Sheldon L. Kaplan said at the meeting. One target may be a vaccine that's directed against noncapsular epitopes, suggested Dr. Kaplan, professor of pediatrics and head of the pediatric infectious diseases section at Baylor College of Medicine, Houston.

Meanwhile, the experimental 15-valent pneumococcal conjugate vaccine (PCV15) would add serotypes 22F and 33F – two of the five most common serotypes seen in invasive pneumococcal disease today. Since the introduction of the first 7-valent pneumococcal conjugate vaccine (PCV7) in 2000, invasive disease from those seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) has nearly disappeared, but disease from non-PCV7 serotypes has been on the rise since at least 2004.

In 2006-2007, 5% of isolates from invasive pneumococcal disease in children younger than 5 years old contained serotype 22F, and 5% contained 33F, which promoted these isolates to candidates for the PCV15 vaccine (J. Infect. Dis. 2010;201:32-41).

The most important serotype accounting for nearly half of invasive pneumococcal disease since introduction of the PCV7 vaccine – serotype 19A – was added to the 13-valent pneumococcal vaccine (PCV13) that was licensed in early 2010. The 2006-2007 data showed that 47% of invasive pneumococcal infections in children under 5 years of age was due to serotype 19A. Other data show that perhaps half of 19A isolates are resistant to three or more classes of antibiotics.

The PCV13 vaccine (Prevnar 13, made by Wyeth Pharmaceuticals Inc. and marketed by Pfizer Inc.) also added serotypes 1, 3, 5, 6A, and 7F. “Serotypes 1 and 3 are very important causes of pneumonia, especially pneumonia with empyema. We don't see much serotype 5 in the United States, so it's not going to make much of an impact there,” Dr. Kaplan said.

The success of PCV7 stokes hopes that PCV13 could have an equally dramatic impact. “I think we're going to see a major decline in invasive disease due to adding these nonvaccine serotypes to the PCV13,” perhaps reducing the current numbers of invasive pneumococcal disease by 70%, he added.

The Advisory Committee on Immunization Practices (ACIP) and the Red Book by the American Academy of Pediatrics' Committee on Infectious Diseases recommend administering PCV13 routinely to children at 2 months of age and suggest a catch-up schedule for children with incomplete vaccination histories.

Centers for Disease Control and Prevention monitoring after introduction of the PCV7 vaccine showed a 70%-75% reduction in overall invasive pneumococcal disease, Dr. Kaplan said.

His institution is part of a coalition of eight children's hospitals that have been monitoring invasive pneumococcal disease since 1994, covering a surveillance population of around 19 million people. Cases of invasive pneumococcal disease decreased from an average of 400-500 cases per year before the PCV7 vaccine to a nadir of 100-200 cases per year in 2004, but the number has slowly crept up since then to 221 cases in 2009, he said (Pediatrics 2010;125:429-36).

As in CDC data, serotype 19A accounts for about half of invasive pneumococcal disease cases in the network's surveillance, he added.

The network data also show that the most prominent type of infection before PCV7, bacteremia, fell from approximately 60% of cases to around 40% of cases post-PCV7. Pneumonia increased from 20% of cases to 30%, and the proportion of isolates associated with bacterial meningitis remained relatively steady, between 11% and 17%.

“In our multicenter study, cases of culture-proven pneumococcal pneumonia declined from 80-100 kids per year to about 40-50 cases/year in 2004, and have slowly climbed back up to more than 60 cases per year,” entirely due to serotypes not included in PCV7, Dr. Kaplan said. Other data have shown a rise in rates of complicated pneumonias, such as empyema, he added.

Although PCV7 was associated with a modest decline in cases of acute otitis media and in the use of antibiotics to treat AOM, at least until 2004, multidrug-resistant serotype 19A is playing a larger role in AOM. “In our studies, 19A accounts for about 60% of pneumococcal isolates recovered from children who have draining ears, myringotomies,” and pressure equalization tubes, he said.

“As a result, we're seeing an increasing number of kids with pneumococcal mastoiditis,” he added. Mastoiditis cases declined from around 5-10 cases per year before PCV7 to 3-4 cases per year, but have totaled 15-25 cases per year in the past few years.

Dr. Kaplan has received grants from Pfizer Inc. and Sanofi Pasteur for investigator-initiated studies, and is a member of pediatric advisory committees for Pfizer, Novartis, and Sanofi Pasteur. He said he has received honoraria from Pfizer, Novartis, GlaxoSmithKline, and Sanofi Pasteur.

'We can't keep adding new serotypes. There are 92 serotypes.'

Source DR. KAPLAN

SAN FRANCISCO — Hard on the heels of approval of the 13-valent pneumococcal conjugate vaccine in early 2010, tests of a 15-valent pneumococcal conjugate vaccine are underway, and researchers are looking for new strategies beyond adding more and more pneumococcal serotypes to the vaccine.

“We can't keep adding new serotypes. There are 92 serotypes,” Dr. Sheldon L. Kaplan said at the meeting. One target may be a vaccine that's directed against noncapsular epitopes, suggested Dr. Kaplan, professor of pediatrics and head of the pediatric infectious diseases section at Baylor College of Medicine, Houston.

Meanwhile, the experimental 15-valent pneumococcal conjugate vaccine (PCV15) would add serotypes 22F and 33F – two of the five most common serotypes seen in invasive pneumococcal disease today. Since the introduction of the first 7-valent pneumococcal conjugate vaccine (PCV7) in 2000, invasive disease from those seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) has nearly disappeared, but disease from non-PCV7 serotypes has been on the rise since at least 2004.

In 2006-2007, 5% of isolates from invasive pneumococcal disease in children younger than 5 years old contained serotype 22F, and 5% contained 33F, which promoted these isolates to candidates for the PCV15 vaccine (J. Infect. Dis. 2010;201:32-41).

The most important serotype accounting for nearly half of invasive pneumococcal disease since introduction of the PCV7 vaccine – serotype 19A – was added to the 13-valent pneumococcal vaccine (PCV13) that was licensed in early 2010. The 2006-2007 data showed that 47% of invasive pneumococcal infections in children under 5 years of age was due to serotype 19A. Other data show that perhaps half of 19A isolates are resistant to three or more classes of antibiotics.

The PCV13 vaccine (Prevnar 13, made by Wyeth Pharmaceuticals Inc. and marketed by Pfizer Inc.) also added serotypes 1, 3, 5, 6A, and 7F. “Serotypes 1 and 3 are very important causes of pneumonia, especially pneumonia with empyema. We don't see much serotype 5 in the United States, so it's not going to make much of an impact there,” Dr. Kaplan said.

The success of PCV7 stokes hopes that PCV13 could have an equally dramatic impact. “I think we're going to see a major decline in invasive disease due to adding these nonvaccine serotypes to the PCV13,” perhaps reducing the current numbers of invasive pneumococcal disease by 70%, he added.

The Advisory Committee on Immunization Practices (ACIP) and the Red Book by the American Academy of Pediatrics' Committee on Infectious Diseases recommend administering PCV13 routinely to children at 2 months of age and suggest a catch-up schedule for children with incomplete vaccination histories.

Centers for Disease Control and Prevention monitoring after introduction of the PCV7 vaccine showed a 70%-75% reduction in overall invasive pneumococcal disease, Dr. Kaplan said.

His institution is part of a coalition of eight children's hospitals that have been monitoring invasive pneumococcal disease since 1994, covering a surveillance population of around 19 million people. Cases of invasive pneumococcal disease decreased from an average of 400-500 cases per year before the PCV7 vaccine to a nadir of 100-200 cases per year in 2004, but the number has slowly crept up since then to 221 cases in 2009, he said (Pediatrics 2010;125:429-36).

As in CDC data, serotype 19A accounts for about half of invasive pneumococcal disease cases in the network's surveillance, he added.

The network data also show that the most prominent type of infection before PCV7, bacteremia, fell from approximately 60% of cases to around 40% of cases post-PCV7. Pneumonia increased from 20% of cases to 30%, and the proportion of isolates associated with bacterial meningitis remained relatively steady, between 11% and 17%.

“In our multicenter study, cases of culture-proven pneumococcal pneumonia declined from 80-100 kids per year to about 40-50 cases/year in 2004, and have slowly climbed back up to more than 60 cases per year,” entirely due to serotypes not included in PCV7, Dr. Kaplan said. Other data have shown a rise in rates of complicated pneumonias, such as empyema, he added.

Although PCV7 was associated with a modest decline in cases of acute otitis media and in the use of antibiotics to treat AOM, at least until 2004, multidrug-resistant serotype 19A is playing a larger role in AOM. “In our studies, 19A accounts for about 60% of pneumococcal isolates recovered from children who have draining ears, myringotomies,” and pressure equalization tubes, he said.

“As a result, we're seeing an increasing number of kids with pneumococcal mastoiditis,” he added. Mastoiditis cases declined from around 5-10 cases per year before PCV7 to 3-4 cases per year, but have totaled 15-25 cases per year in the past few years.

Dr. Kaplan has received grants from Pfizer Inc. and Sanofi Pasteur for investigator-initiated studies, and is a member of pediatric advisory committees for Pfizer, Novartis, and Sanofi Pasteur. He said he has received honoraria from Pfizer, Novartis, GlaxoSmithKline, and Sanofi Pasteur.

'We can't keep adding new serotypes. There are 92 serotypes.'

Source DR. KAPLAN

SAN FRANCISCO — Parents may think they know when their child has an acute ear infection, but they don't.

That's the implication of a study of children aged 6-35 months that showed parents' reasons for suspecting acute otitis media, symptoms, and symptom scores could not differentiate 237 children with acute otitis media from 232 who had respiratory tract infection without acute otitis media. Only when tympanic-membrane examination was added to these clues could the diagnosis be made (Pediatrics 2010;125:e1154-e1161).

“For me, this study has quite a lot of meaning,” Dr. Ellen R. Wald said at the meeting. “Parental diagnosis of acute otitis media” is not reliable. “We shouldn't let the presence of those historical items persuade us” to accept a presumed diagnosis.

The diagnosis of acute otitis media relies heavily on accurate otoscopy, said Dr. Wald, who is professor and chair of pediatrics at the University of Wisconsin, Madison.

She did not participate in the Finnish study, in which parents completed structured questionnaires on the occurrence, duration, and severity of symptoms before otoscopic examination of the child.

The reasons that parents thought a child might have an ear infection did not differ significantly between groups. In the children with and without acute otitis media, respectively, parental suspicion was raised by restless sleep in 28% and 29%, ear pain in 13% and 9%, ear rubbing in 10% and 18%, severe or prolonged rhinitis or cough in 9% and 7%, and irritability in 17% and 19%.

Fever also did not differentiate between the two groups. The highest measured temperatures within the previous 24 hours did not differ significantly between children with or without acute otitis media.

Otoscopy also is essential to differentiate acute otitis media from otitis media with effusion, Dr. Wald added. Acute otitis media results from a bacterial infection, and antibiotic therapy may help. Otitis media with effusion is a sterile, nonbacterial inflammatory state that resolves spontaneously, and antibiotic therapy is neither appropriate nor beneficial. Otitis media with effusion causes hearing loss, which is a confounder for acute otitis media, she said.

Dr. Wald said she has no relevant conflicts of interest.

SAN FRANCISCO — Parents may think they know when their child has an acute ear infection, but they don't.

That's the implication of a study of children aged 6-35 months that showed parents' reasons for suspecting acute otitis media, symptoms, and symptom scores could not differentiate 237 children with acute otitis media from 232 who had respiratory tract infection without acute otitis media. Only when tympanic-membrane examination was added to these clues could the diagnosis be made (Pediatrics 2010;125:e1154-e1161).

“For me, this study has quite a lot of meaning,” Dr. Ellen R. Wald said at the meeting. “Parental diagnosis of acute otitis media” is not reliable. “We shouldn't let the presence of those historical items persuade us” to accept a presumed diagnosis.

The diagnosis of acute otitis media relies heavily on accurate otoscopy, said Dr. Wald, who is professor and chair of pediatrics at the University of Wisconsin, Madison.

She did not participate in the Finnish study, in which parents completed structured questionnaires on the occurrence, duration, and severity of symptoms before otoscopic examination of the child.

The reasons that parents thought a child might have an ear infection did not differ significantly between groups. In the children with and without acute otitis media, respectively, parental suspicion was raised by restless sleep in 28% and 29%, ear pain in 13% and 9%, ear rubbing in 10% and 18%, severe or prolonged rhinitis or cough in 9% and 7%, and irritability in 17% and 19%.

Fever also did not differentiate between the two groups. The highest measured temperatures within the previous 24 hours did not differ significantly between children with or without acute otitis media.

Otoscopy also is essential to differentiate acute otitis media from otitis media with effusion, Dr. Wald added. Acute otitis media results from a bacterial infection, and antibiotic therapy may help. Otitis media with effusion is a sterile, nonbacterial inflammatory state that resolves spontaneously, and antibiotic therapy is neither appropriate nor beneficial. Otitis media with effusion causes hearing loss, which is a confounder for acute otitis media, she said.

Dr. Wald said she has no relevant conflicts of interest.

SAN FRANCISCO — Parents may think they know when their child has an acute ear infection, but they don't.

That's the implication of a study of children aged 6-35 months that showed parents' reasons for suspecting acute otitis media, symptoms, and symptom scores could not differentiate 237 children with acute otitis media from 232 who had respiratory tract infection without acute otitis media. Only when tympanic-membrane examination was added to these clues could the diagnosis be made (Pediatrics 2010;125:e1154-e1161).

“For me, this study has quite a lot of meaning,” Dr. Ellen R. Wald said at the meeting. “Parental diagnosis of acute otitis media” is not reliable. “We shouldn't let the presence of those historical items persuade us” to accept a presumed diagnosis.

The diagnosis of acute otitis media relies heavily on accurate otoscopy, said Dr. Wald, who is professor and chair of pediatrics at the University of Wisconsin, Madison.

She did not participate in the Finnish study, in which parents completed structured questionnaires on the occurrence, duration, and severity of symptoms before otoscopic examination of the child.

The reasons that parents thought a child might have an ear infection did not differ significantly between groups. In the children with and without acute otitis media, respectively, parental suspicion was raised by restless sleep in 28% and 29%, ear pain in 13% and 9%, ear rubbing in 10% and 18%, severe or prolonged rhinitis or cough in 9% and 7%, and irritability in 17% and 19%.

Fever also did not differentiate between the two groups. The highest measured temperatures within the previous 24 hours did not differ significantly between children with or without acute otitis media.

Otoscopy also is essential to differentiate acute otitis media from otitis media with effusion, Dr. Wald added. Acute otitis media results from a bacterial infection, and antibiotic therapy may help. Otitis media with effusion is a sterile, nonbacterial inflammatory state that resolves spontaneously, and antibiotic therapy is neither appropriate nor beneficial. Otitis media with effusion causes hearing loss, which is a confounder for acute otitis media, she said.

Dr. Wald said she has no relevant conflicts of interest.

SAN FRANCISCO — Antibiotic therapy for acute otitis media may be more effective than some physicians think, a study has shown.

Some new data add to controversy that has been stirring since 2004 clinical practice guidelines from the American Academy of Pediatrics and the American Academy of Family Physicians included the option of watchful waiting in some children with uncomplicated acute otitis media (Pediatrics 2004;113:1451-65).

Support for management by observation came primarily from the desire to avoid escalation of antibiotic resistance and from the results of several meta-analyses suggesting that antibiotics are only modestly beneficial in treating acute otitis media, compared with placebo.

“Many of the meta-analyses had substantial flaws,” and included studies that used weak definitions of acute otitis media and so classified some children who had otitis media with effusion as having acute otitis media, Dr. Ellen R. Wald said at the meeting.

Because antibiotic therapy does not help otitis media with effusion, it's no wonder that antibiotics barely outperformed placebo in these studies, said Dr. Wald, professor and chair of pediatrics at the University of Wisconsin, Madison.

She described a new study led Dr. Alejandro Hoberman, chief of pediatrics at Children's Hospital, Philadelphia, that found significantly lower rates of treatment failure in children treated with amoxicillin-clavulanate, compared with placebo, she added. The results have been submitted for publication.

The study randomized 291 children who were aged 6-23 months and had confirmed acute otitis media to treatment with the antibiotics or placebo for 10 days, with follow-up on days 4/5, days 10/12, and days 21/25. Patients with clinical failure to first-round therapy received amoxicillin and cefixime.

The amoxicillin-clavulanate treatment failed at or before days 4/5 in 4% of patients, compared with a 23% clinical failure rate in the placebo group (P less than .001). Clinical failure rates at or before days 10-12 were 16% in the amoxicillin-clavulanate group and 51% in the placebo group (P less than .001).

These differences are “more dramatic than in previously reported trials,” Dr. Wald said. For children aged 6-23 months who have acute otitis media, treatment with amoxicillin-clavulanate for 10 days provides measurable short-term benefit, she said.

In a separate study by other investigators, surveys completed by 1,114 physicians found no significant increase in the proportion who managed acute otitis media without antibiotics after the guidelines (16%), compared with before the guidelines (11%), she added (Pediatrics 2010 [doi:10.1542/peds.2009-1115]).

Dr. Wald said that she had no relevant conflicts of interest.

'Many of the meta-analyses [supporting management by observation] had substantial flaws.'

Source DR. WALD

SAN FRANCISCO — Antibiotic therapy for acute otitis media may be more effective than some physicians think, a study has shown.

Some new data add to controversy that has been stirring since 2004 clinical practice guidelines from the American Academy of Pediatrics and the American Academy of Family Physicians included the option of watchful waiting in some children with uncomplicated acute otitis media (Pediatrics 2004;113:1451-65).

Support for management by observation came primarily from the desire to avoid escalation of antibiotic resistance and from the results of several meta-analyses suggesting that antibiotics are only modestly beneficial in treating acute otitis media, compared with placebo.

“Many of the meta-analyses had substantial flaws,” and included studies that used weak definitions of acute otitis media and so classified some children who had otitis media with effusion as having acute otitis media, Dr. Ellen R. Wald said at the meeting.

Because antibiotic therapy does not help otitis media with effusion, it's no wonder that antibiotics barely outperformed placebo in these studies, said Dr. Wald, professor and chair of pediatrics at the University of Wisconsin, Madison.

She described a new study led Dr. Alejandro Hoberman, chief of pediatrics at Children's Hospital, Philadelphia, that found significantly lower rates of treatment failure in children treated with amoxicillin-clavulanate, compared with placebo, she added. The results have been submitted for publication.

The study randomized 291 children who were aged 6-23 months and had confirmed acute otitis media to treatment with the antibiotics or placebo for 10 days, with follow-up on days 4/5, days 10/12, and days 21/25. Patients with clinical failure to first-round therapy received amoxicillin and cefixime.

The amoxicillin-clavulanate treatment failed at or before days 4/5 in 4% of patients, compared with a 23% clinical failure rate in the placebo group (P less than .001). Clinical failure rates at or before days 10-12 were 16% in the amoxicillin-clavulanate group and 51% in the placebo group (P less than .001).

These differences are “more dramatic than in previously reported trials,” Dr. Wald said. For children aged 6-23 months who have acute otitis media, treatment with amoxicillin-clavulanate for 10 days provides measurable short-term benefit, she said.

In a separate study by other investigators, surveys completed by 1,114 physicians found no significant increase in the proportion who managed acute otitis media without antibiotics after the guidelines (16%), compared with before the guidelines (11%), she added (Pediatrics 2010 [doi:10.1542/peds.2009-1115]).

Dr. Wald said that she had no relevant conflicts of interest.

'Many of the meta-analyses [supporting management by observation] had substantial flaws.'

Source DR. WALD

SAN FRANCISCO — Antibiotic therapy for acute otitis media may be more effective than some physicians think, a study has shown.

Some new data add to controversy that has been stirring since 2004 clinical practice guidelines from the American Academy of Pediatrics and the American Academy of Family Physicians included the option of watchful waiting in some children with uncomplicated acute otitis media (Pediatrics 2004;113:1451-65).

Support for management by observation came primarily from the desire to avoid escalation of antibiotic resistance and from the results of several meta-analyses suggesting that antibiotics are only modestly beneficial in treating acute otitis media, compared with placebo.

“Many of the meta-analyses had substantial flaws,” and included studies that used weak definitions of acute otitis media and so classified some children who had otitis media with effusion as having acute otitis media, Dr. Ellen R. Wald said at the meeting.

Because antibiotic therapy does not help otitis media with effusion, it's no wonder that antibiotics barely outperformed placebo in these studies, said Dr. Wald, professor and chair of pediatrics at the University of Wisconsin, Madison.

She described a new study led Dr. Alejandro Hoberman, chief of pediatrics at Children's Hospital, Philadelphia, that found significantly lower rates of treatment failure in children treated with amoxicillin-clavulanate, compared with placebo, she added. The results have been submitted for publication.

The study randomized 291 children who were aged 6-23 months and had confirmed acute otitis media to treatment with the antibiotics or placebo for 10 days, with follow-up on days 4/5, days 10/12, and days 21/25. Patients with clinical failure to first-round therapy received amoxicillin and cefixime.

The amoxicillin-clavulanate treatment failed at or before days 4/5 in 4% of patients, compared with a 23% clinical failure rate in the placebo group (P less than .001). Clinical failure rates at or before days 10-12 were 16% in the amoxicillin-clavulanate group and 51% in the placebo group (P less than .001).

These differences are “more dramatic than in previously reported trials,” Dr. Wald said. For children aged 6-23 months who have acute otitis media, treatment with amoxicillin-clavulanate for 10 days provides measurable short-term benefit, she said.

In a separate study by other investigators, surveys completed by 1,114 physicians found no significant increase in the proportion who managed acute otitis media without antibiotics after the guidelines (16%), compared with before the guidelines (11%), she added (Pediatrics 2010 [doi:10.1542/peds.2009-1115]).

Dr. Wald said that she had no relevant conflicts of interest.

'Many of the meta-analyses [supporting management by observation] had substantial flaws.'

Source DR. WALD

Major Finding: Taking a daily pill containing the antiretroviral drugs emtricitabine and tenofovir along with using conventional HIV prevention strategies reduced the risk of acquiring HIV by 44% on average in men or transgender women who have sex with men.

Data Source: Randomized, blinded, placebo-controlled trial in 2,499 subjects in six countries.

Disclosures: The National Institutes of Health and the Bill and Melinda Gates Foundation funded the study. Gilead Sciences donated the FTC-TDF and placebo tablets, and provided some travel funding for investigators. Two of the investigators worked for Gilead. Disclosures for individual investigators are posted with the article at

Taking a daily pill containing two antiretroviral drugs plus exposure to conventional HIV prevention strategies reduced the risk of acquiring HIV by an average of 44% in the people at highest risk of getting infected – men and transgender women who have sex with men, a study has shown.

The Preexposure Prophylaxis Initiative (iPrEx) study randomized 2,499 subjects in six countries to take a daily pill containing placebo or a combination of emtricitabine and tenofovir disoproxil fumarate (FTC-TDF).

All of the study subjects also received regular HIV testing, condoms, counseling on reducing risks for HIV, and management of sexually transmitted infections.

During a median follow-up of 1.2 years (and a maximum of 2.8 years), 36 of 1,251 subjects in the FTC-TDF group (3%) acquired HIV, compared with 64 of 1,248 subjects in the placebo group (5%).

The preventive efficacy of FTC-TDF was significant but not as high as investigators had hoped, according to Dr. Robert M. Grant of the University of California, San Francisco, and his associates (N. Engl. J. Med. 2010 Nov. 23 [doi:10.1056/NEJMoa1011205]).

Although most subjects reported taking the pills, objective measures of exposure to the drugs suggested substantially lower adherence rates. When intracellular assays showed that subjects had been exposed to FTC-TDF, they were much less likely to acquire HIV. Evidence of FTC-TDF was seen in only 3 of 34 HIV-infected subjects (9%), compared with 22 of 43 HIV-negative subjects (51%) in the FTC-TDF group.

“It's very exciting news,” Dr. Moupali Das said in an interview. “These are extremely promising results,” said Dr. Das of the University of California, San Francisco, and director of research in the HIV prevention section of the San Francisco Deapartment of Public Health.

Dr. Das was not involved in the iPrEx study.

The findings are consistent with results from a separate preexposure prophylaxis trial reported earlier in 2010, which showed an overall 39% reduction in HIV infections in women who agreed to apply a 1% tenofovir gel vaginally before and after sex, Dr. Das noted.

The randomized, double-blind placebo-controlled Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 trial studied 889 sexually active African women (Science 2010;329:1168-74).

The iPrEx study enrolled subjects at multiple centers in the United States, South Africa, Brazil, Ecuador, Peru, and Thailand.

Patients in the FTC-TDF group were significantly more likely to develop nausea (2%) in the first 4 weeks of treatment, compared with the placebo group (less than 1%).

“It's a groundbreaking study,” but several factors will temper excitement among clinicians, said Dr. Grant Colfax, director of HIV prevention for the San Francisco Department of Public Health.

Dr. Colfax was not involved in the iPrEx study.

The FTC-TDF pill is expensive, costing $750 per month or more in the United States, he noted in an interview. Subjects in the study got comprehensive care with monthly HIV testing, state-of-the-art prevention counseling, free condoms, and more, which might not be representative of the real world.

“This was not just giving someone a pill and walking out of the office,” Dr. Colfax said.

Two subjects in the FTC-TDF group who later were found to have had HIV at enrollment both developed resistance to FTC, compared with one of eight subjects on placebo with HIV at enrollment.

People at risk for HIV should not start taking FTC-TDF without reviewing the risks and benefits with their physician, Dr. Colfax said.

The study does not answer questions about the advisability of implementing this prevention strategy in all or even most HIV-negative people at risk for acquiring the infection, Dr. Das agreed.

“It will be important to see the results of the upcoming trials on different ways to provide preexposure prophylaxis,” results of which should be available in the near future, Dr. Das said.

The Web site of the nonprofit group AVAC: Global Advocacy for HIV Prevention (www.avac.org

In the meantime, there might be some specific populations in whom preexposure prophylaxis with FTC-TDF makes sense while research continues, she added.

Some clinicians already offer preexposure prophylaxis to HIV-negative people whose sexual partners have HIV or to serodiscordant couples who can't use other modes of preventing infection.

Further research might identify ways to reduce the frequency and expense of preexposure prophylaxis, Dr. Das suggested, such as perhaps taking FTC-TDF only during high-risk periods of life, similar to the way women use contraceptives mainly during the sexually active years.

The main obstacle for most people will be cost, especially for the low-income or indigent patients Dr. Das sees in her practice.

“I could write a prescription, but I don't know how they would be able to pay for it,” she said. Still, FTC-TDF is “another potential tool in our prevention toolkit.”

The rate of HIV infection has been climbing since the early 1990s in U.S. men and transgender women who have sex with men, especially in black and Hispanic populations, the investigators in the iPrEx study indicated.

In almost all countries, the prevalence of HIV is higher among men and transgender women who have sex with men, compared with other groups.

Major Finding: Taking a daily pill containing the antiretroviral drugs emtricitabine and tenofovir along with using conventional HIV prevention strategies reduced the risk of acquiring HIV by 44% on average in men or transgender women who have sex with men.

Data Source: Randomized, blinded, placebo-controlled trial in 2,499 subjects in six countries.

Disclosures: The National Institutes of Health and the Bill and Melinda Gates Foundation funded the study. Gilead Sciences donated the FTC-TDF and placebo tablets, and provided some travel funding for investigators. Two of the investigators worked for Gilead. Disclosures for individual investigators are posted with the article at

Taking a daily pill containing two antiretroviral drugs plus exposure to conventional HIV prevention strategies reduced the risk of acquiring HIV by an average of 44% in the people at highest risk of getting infected – men and transgender women who have sex with men, a study has shown.

The Preexposure Prophylaxis Initiative (iPrEx) study randomized 2,499 subjects in six countries to take a daily pill containing placebo or a combination of emtricitabine and tenofovir disoproxil fumarate (FTC-TDF).

All of the study subjects also received regular HIV testing, condoms, counseling on reducing risks for HIV, and management of sexually transmitted infections.

During a median follow-up of 1.2 years (and a maximum of 2.8 years), 36 of 1,251 subjects in the FTC-TDF group (3%) acquired HIV, compared with 64 of 1,248 subjects in the placebo group (5%).

The preventive efficacy of FTC-TDF was significant but not as high as investigators had hoped, according to Dr. Robert M. Grant of the University of California, San Francisco, and his associates (N. Engl. J. Med. 2010 Nov. 23 [doi:10.1056/NEJMoa1011205]).

Although most subjects reported taking the pills, objective measures of exposure to the drugs suggested substantially lower adherence rates. When intracellular assays showed that subjects had been exposed to FTC-TDF, they were much less likely to acquire HIV. Evidence of FTC-TDF was seen in only 3 of 34 HIV-infected subjects (9%), compared with 22 of 43 HIV-negative subjects (51%) in the FTC-TDF group.

“It's very exciting news,” Dr. Moupali Das said in an interview. “These are extremely promising results,” said Dr. Das of the University of California, San Francisco, and director of research in the HIV prevention section of the San Francisco Deapartment of Public Health.

Dr. Das was not involved in the iPrEx study.

The findings are consistent with results from a separate preexposure prophylaxis trial reported earlier in 2010, which showed an overall 39% reduction in HIV infections in women who agreed to apply a 1% tenofovir gel vaginally before and after sex, Dr. Das noted.

The randomized, double-blind placebo-controlled Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 trial studied 889 sexually active African women (Science 2010;329:1168-74).

The iPrEx study enrolled subjects at multiple centers in the United States, South Africa, Brazil, Ecuador, Peru, and Thailand.

Patients in the FTC-TDF group were significantly more likely to develop nausea (2%) in the first 4 weeks of treatment, compared with the placebo group (less than 1%).

“It's a groundbreaking study,” but several factors will temper excitement among clinicians, said Dr. Grant Colfax, director of HIV prevention for the San Francisco Department of Public Health.

Dr. Colfax was not involved in the iPrEx study.

The FTC-TDF pill is expensive, costing $750 per month or more in the United States, he noted in an interview. Subjects in the study got comprehensive care with monthly HIV testing, state-of-the-art prevention counseling, free condoms, and more, which might not be representative of the real world.

“This was not just giving someone a pill and walking out of the office,” Dr. Colfax said.

Two subjects in the FTC-TDF group who later were found to have had HIV at enrollment both developed resistance to FTC, compared with one of eight subjects on placebo with HIV at enrollment.

People at risk for HIV should not start taking FTC-TDF without reviewing the risks and benefits with their physician, Dr. Colfax said.

The study does not answer questions about the advisability of implementing this prevention strategy in all or even most HIV-negative people at risk for acquiring the infection, Dr. Das agreed.

“It will be important to see the results of the upcoming trials on different ways to provide preexposure prophylaxis,” results of which should be available in the near future, Dr. Das said.

The Web site of the nonprofit group AVAC: Global Advocacy for HIV Prevention (www.avac.org

In the meantime, there might be some specific populations in whom preexposure prophylaxis with FTC-TDF makes sense while research continues, she added.

Some clinicians already offer preexposure prophylaxis to HIV-negative people whose sexual partners have HIV or to serodiscordant couples who can't use other modes of preventing infection.

Further research might identify ways to reduce the frequency and expense of preexposure prophylaxis, Dr. Das suggested, such as perhaps taking FTC-TDF only during high-risk periods of life, similar to the way women use contraceptives mainly during the sexually active years.

The main obstacle for most people will be cost, especially for the low-income or indigent patients Dr. Das sees in her practice.

“I could write a prescription, but I don't know how they would be able to pay for it,” she said. Still, FTC-TDF is “another potential tool in our prevention toolkit.”

The rate of HIV infection has been climbing since the early 1990s in U.S. men and transgender women who have sex with men, especially in black and Hispanic populations, the investigators in the iPrEx study indicated.

In almost all countries, the prevalence of HIV is higher among men and transgender women who have sex with men, compared with other groups.

Major Finding: Taking a daily pill containing the antiretroviral drugs emtricitabine and tenofovir along with using conventional HIV prevention strategies reduced the risk of acquiring HIV by 44% on average in men or transgender women who have sex with men.

Data Source: Randomized, blinded, placebo-controlled trial in 2,499 subjects in six countries.

Disclosures: The National Institutes of Health and the Bill and Melinda Gates Foundation funded the study. Gilead Sciences donated the FTC-TDF and placebo tablets, and provided some travel funding for investigators. Two of the investigators worked for Gilead. Disclosures for individual investigators are posted with the article at

Taking a daily pill containing two antiretroviral drugs plus exposure to conventional HIV prevention strategies reduced the risk of acquiring HIV by an average of 44% in the people at highest risk of getting infected – men and transgender women who have sex with men, a study has shown.

The Preexposure Prophylaxis Initiative (iPrEx) study randomized 2,499 subjects in six countries to take a daily pill containing placebo or a combination of emtricitabine and tenofovir disoproxil fumarate (FTC-TDF).

All of the study subjects also received regular HIV testing, condoms, counseling on reducing risks for HIV, and management of sexually transmitted infections.

During a median follow-up of 1.2 years (and a maximum of 2.8 years), 36 of 1,251 subjects in the FTC-TDF group (3%) acquired HIV, compared with 64 of 1,248 subjects in the placebo group (5%).

The preventive efficacy of FTC-TDF was significant but not as high as investigators had hoped, according to Dr. Robert M. Grant of the University of California, San Francisco, and his associates (N. Engl. J. Med. 2010 Nov. 23 [doi:10.1056/NEJMoa1011205]).

Although most subjects reported taking the pills, objective measures of exposure to the drugs suggested substantially lower adherence rates. When intracellular assays showed that subjects had been exposed to FTC-TDF, they were much less likely to acquire HIV. Evidence of FTC-TDF was seen in only 3 of 34 HIV-infected subjects (9%), compared with 22 of 43 HIV-negative subjects (51%) in the FTC-TDF group.

“It's very exciting news,” Dr. Moupali Das said in an interview. “These are extremely promising results,” said Dr. Das of the University of California, San Francisco, and director of research in the HIV prevention section of the San Francisco Deapartment of Public Health.

Dr. Das was not involved in the iPrEx study.

The findings are consistent with results from a separate preexposure prophylaxis trial reported earlier in 2010, which showed an overall 39% reduction in HIV infections in women who agreed to apply a 1% tenofovir gel vaginally before and after sex, Dr. Das noted.

The randomized, double-blind placebo-controlled Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 trial studied 889 sexually active African women (Science 2010;329:1168-74).

The iPrEx study enrolled subjects at multiple centers in the United States, South Africa, Brazil, Ecuador, Peru, and Thailand.

Patients in the FTC-TDF group were significantly more likely to develop nausea (2%) in the first 4 weeks of treatment, compared with the placebo group (less than 1%).

“It's a groundbreaking study,” but several factors will temper excitement among clinicians, said Dr. Grant Colfax, director of HIV prevention for the San Francisco Department of Public Health.

Dr. Colfax was not involved in the iPrEx study.

The FTC-TDF pill is expensive, costing $750 per month or more in the United States, he noted in an interview. Subjects in the study got comprehensive care with monthly HIV testing, state-of-the-art prevention counseling, free condoms, and more, which might not be representative of the real world.

“This was not just giving someone a pill and walking out of the office,” Dr. Colfax said.

Two subjects in the FTC-TDF group who later were found to have had HIV at enrollment both developed resistance to FTC, compared with one of eight subjects on placebo with HIV at enrollment.

People at risk for HIV should not start taking FTC-TDF without reviewing the risks and benefits with their physician, Dr. Colfax said.

The study does not answer questions about the advisability of implementing this prevention strategy in all or even most HIV-negative people at risk for acquiring the infection, Dr. Das agreed.

“It will be important to see the results of the upcoming trials on different ways to provide preexposure prophylaxis,” results of which should be available in the near future, Dr. Das said.

The Web site of the nonprofit group AVAC: Global Advocacy for HIV Prevention (www.avac.org

In the meantime, there might be some specific populations in whom preexposure prophylaxis with FTC-TDF makes sense while research continues, she added.

Some clinicians already offer preexposure prophylaxis to HIV-negative people whose sexual partners have HIV or to serodiscordant couples who can't use other modes of preventing infection.

Further research might identify ways to reduce the frequency and expense of preexposure prophylaxis, Dr. Das suggested, such as perhaps taking FTC-TDF only during high-risk periods of life, similar to the way women use contraceptives mainly during the sexually active years.

The main obstacle for most people will be cost, especially for the low-income or indigent patients Dr. Das sees in her practice.

“I could write a prescription, but I don't know how they would be able to pay for it,” she said. Still, FTC-TDF is “another potential tool in our prevention toolkit.”

The rate of HIV infection has been climbing since the early 1990s in U.S. men and transgender women who have sex with men, especially in black and Hispanic populations, the investigators in the iPrEx study indicated.

In almost all countries, the prevalence of HIV is higher among men and transgender women who have sex with men, compared with other groups.