Heidi Splete

CHICAGO – Significantly more polyps were detected during colonoscopies when an anesthesiologist was present, compared with colonoscopies without an anesthesiologist, based on data from more than 4.5 million index colonoscopies. The findings were presented at the annual Digestive Disease Week.

Use of an anesthesiologist during colonoscopy has been associated with improved patient and provider satisfaction, but the diagnostic impact on polyp detection has not been well studied, said Dr. Brooks D. Cash of the National Naval Medical Center in Bethesda, Md.

The report "represents one of the first products of the new AGA [American Gastroenterological Association] Digestive Health Outcomes Registry," said Dr. Cash. "It has become increasingly important to have registries that look at quality and effectiveness of what we do as gastroenterologists," he said.

In this study, Dr. Cash and colleagues reviewed data from 4,539,547 index colonoscopies performed between 2001 and 2010. Based on coding data, approximately one-third of the colonoscopies involved an anesthesiologist.

Overall, the polyp detection rate was 37.7% for procedures with an anesthesiologist present, compared with 37% in procedures without an anesthesiologist. Because of the large numbers in the study, this difference was statistically significant (P less than .05).

In addition, significantly more individuals were diagnosed with colorectal cancer within 3 years of the index colonoscopy with an anesthesiologist present than without an anesthesiologist (1.97% vs. 1.71%).

Among men, the polyp detection rate was 43.18% with an anesthesiologist and 43.08% without an anesthesiologist. Among women, these rates were 33.17% and 31.95%, respectively. The differences were significant for both sexes.

The differences in colorectal cancer diagnosis after 3 years also remained significant by sex, the researchers noted. Among men, 2.12% of those who had an anesthesiologist present for their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.93% of those without an anesthesiologist present. Among women, 1.84% of those who had an anesthesiologist present at their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.54% of those without an anesthesiologist present.

The trends held constant for age as well as sex: Both polyp detection and colon cancer incidence after 3 years were slightly higher when an anesthesiologist was present for patients aged younger than 65 years and for those aged 65 years and older.

The study is important because there are significant costs – up to $700 per case – when an anesthesiologist is involved in a colonoscopy, although the cost varies by region, Dr. Cash said.

The use of anesthesiologists for colonoscopies began with comorbid patients who had a higher risk of moderate sedation complications, Dr. Cash said. "We have seen that the use of anesthesiologists has become more common, even for patients who are at average risk," he noted.

"What we are going to have to figure out as a society and as professional organizations is whether those additional costs merit the very slight increases in polyp detection rate," said Dr. Cash. "We also need to figure out why the colorectal cancer incidence 3 years after index colonoscopies with anesthesia providers is slightly higher," he said.

Dr. Cash had no financial conflicts to disclose.

CHICAGO – Significantly more polyps were detected during colonoscopies when an anesthesiologist was present, compared with colonoscopies without an anesthesiologist, based on data from more than 4.5 million index colonoscopies. The findings were presented at the annual Digestive Disease Week.

Use of an anesthesiologist during colonoscopy has been associated with improved patient and provider satisfaction, but the diagnostic impact on polyp detection has not been well studied, said Dr. Brooks D. Cash of the National Naval Medical Center in Bethesda, Md.

The report "represents one of the first products of the new AGA [American Gastroenterological Association] Digestive Health Outcomes Registry," said Dr. Cash. "It has become increasingly important to have registries that look at quality and effectiveness of what we do as gastroenterologists," he said.

In this study, Dr. Cash and colleagues reviewed data from 4,539,547 index colonoscopies performed between 2001 and 2010. Based on coding data, approximately one-third of the colonoscopies involved an anesthesiologist.

Overall, the polyp detection rate was 37.7% for procedures with an anesthesiologist present, compared with 37% in procedures without an anesthesiologist. Because of the large numbers in the study, this difference was statistically significant (P less than .05).

In addition, significantly more individuals were diagnosed with colorectal cancer within 3 years of the index colonoscopy with an anesthesiologist present than without an anesthesiologist (1.97% vs. 1.71%).

Among men, the polyp detection rate was 43.18% with an anesthesiologist and 43.08% without an anesthesiologist. Among women, these rates were 33.17% and 31.95%, respectively. The differences were significant for both sexes.

The differences in colorectal cancer diagnosis after 3 years also remained significant by sex, the researchers noted. Among men, 2.12% of those who had an anesthesiologist present for their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.93% of those without an anesthesiologist present. Among women, 1.84% of those who had an anesthesiologist present at their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.54% of those without an anesthesiologist present.

The trends held constant for age as well as sex: Both polyp detection and colon cancer incidence after 3 years were slightly higher when an anesthesiologist was present for patients aged younger than 65 years and for those aged 65 years and older.

The study is important because there are significant costs – up to $700 per case – when an anesthesiologist is involved in a colonoscopy, although the cost varies by region, Dr. Cash said.

The use of anesthesiologists for colonoscopies began with comorbid patients who had a higher risk of moderate sedation complications, Dr. Cash said. "We have seen that the use of anesthesiologists has become more common, even for patients who are at average risk," he noted.

"What we are going to have to figure out as a society and as professional organizations is whether those additional costs merit the very slight increases in polyp detection rate," said Dr. Cash. "We also need to figure out why the colorectal cancer incidence 3 years after index colonoscopies with anesthesia providers is slightly higher," he said.

Dr. Cash had no financial conflicts to disclose.

CHICAGO – Significantly more polyps were detected during colonoscopies when an anesthesiologist was present, compared with colonoscopies without an anesthesiologist, based on data from more than 4.5 million index colonoscopies. The findings were presented at the annual Digestive Disease Week.

Use of an anesthesiologist during colonoscopy has been associated with improved patient and provider satisfaction, but the diagnostic impact on polyp detection has not been well studied, said Dr. Brooks D. Cash of the National Naval Medical Center in Bethesda, Md.

The report "represents one of the first products of the new AGA [American Gastroenterological Association] Digestive Health Outcomes Registry," said Dr. Cash. "It has become increasingly important to have registries that look at quality and effectiveness of what we do as gastroenterologists," he said.

In this study, Dr. Cash and colleagues reviewed data from 4,539,547 index colonoscopies performed between 2001 and 2010. Based on coding data, approximately one-third of the colonoscopies involved an anesthesiologist.

Overall, the polyp detection rate was 37.7% for procedures with an anesthesiologist present, compared with 37% in procedures without an anesthesiologist. Because of the large numbers in the study, this difference was statistically significant (P less than .05).

In addition, significantly more individuals were diagnosed with colorectal cancer within 3 years of the index colonoscopy with an anesthesiologist present than without an anesthesiologist (1.97% vs. 1.71%).

Among men, the polyp detection rate was 43.18% with an anesthesiologist and 43.08% without an anesthesiologist. Among women, these rates were 33.17% and 31.95%, respectively. The differences were significant for both sexes.

The differences in colorectal cancer diagnosis after 3 years also remained significant by sex, the researchers noted. Among men, 2.12% of those who had an anesthesiologist present for their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.93% of those without an anesthesiologist present. Among women, 1.84% of those who had an anesthesiologist present at their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.54% of those without an anesthesiologist present.

The trends held constant for age as well as sex: Both polyp detection and colon cancer incidence after 3 years were slightly higher when an anesthesiologist was present for patients aged younger than 65 years and for those aged 65 years and older.

The study is important because there are significant costs – up to $700 per case – when an anesthesiologist is involved in a colonoscopy, although the cost varies by region, Dr. Cash said.

The use of anesthesiologists for colonoscopies began with comorbid patients who had a higher risk of moderate sedation complications, Dr. Cash said. "We have seen that the use of anesthesiologists has become more common, even for patients who are at average risk," he noted.

"What we are going to have to figure out as a society and as professional organizations is whether those additional costs merit the very slight increases in polyp detection rate," said Dr. Cash. "We also need to figure out why the colorectal cancer incidence 3 years after index colonoscopies with anesthesia providers is slightly higher," he said.

Dr. Cash had no financial conflicts to disclose.

CHICAGO – Significantly more polyps were detected during colonoscopies when an anesthesiologist was present, compared with colonoscopies without an anesthesiologist, based on data from more than 4.5 million index colonoscopies. The findings were presented at the annual Digestive Disease Week.

Use of an anesthesiologist during colonoscopy has been associated with improved patient and provider satisfaction, but the diagnostic impact on polyp detection has not been well studied, said Dr. Brooks D. Cash of the National Naval Medical Center in Bethesda, Md.

The report "represents one of the first products of the new AGA [American Gastroenterological Association] Digestive Health Outcomes Registry," said Dr. Cash. "It has become increasingly important to have registries that look at quality and effectiveness of what we do as gastroenterologists," he said.

In this study, Dr. Cash and colleagues reviewed data from 4,539,547 index colonoscopies performed between 2001 and 2010. Based on coding data, approximately one-third of the colonoscopies involved an anesthesiologist.

Overall, the polyp detection rate was 37.7% for procedures with an anesthesiologist present, compared with 37% in procedures without an anesthesiologist. Because of the large numbers in the study, this difference was statistically significant (P less than .05).

In addition, significantly more individuals were diagnosed with colorectal cancer within 3 years of the index colonoscopy with an anesthesiologist present than without an anesthesiologist (1.97% vs. 1.71%).

Among men, the polyp detection rate was 43.18% with an anesthesiologist and 43.08% without an anesthesiologist. Among women, these rates were 33.17% and 31.95%, respectively. The differences were significant for both sexes.

The differences in colorectal cancer diagnosis after 3 years also remained significant by sex, the researchers noted. Among men, 2.12% of those who had an anesthesiologist present for their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.93% of those without an anesthesiologist present. Among women, 1.84% of those who had an anesthesiologist present at their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.54% of those without an anesthesiologist present.

The trends held constant for age as well as sex: Both polyp detection and colon cancer incidence after 3 years were slightly higher when an anesthesiologist was present for patients aged younger than 65 years and for those aged 65 years and older.

The study is important because there are significant costs – up to $700 per case – when an anesthesiologist is involved in a colonoscopy, although the cost varies by region, Dr. Cash said.

The use of anesthesiologists for colonoscopies began with comorbid patients who had a higher risk of moderate sedation complications, Dr. Cash said. "We have seen that the use of anesthesiologists has become more common, even for patients who are at average risk," he noted.

"What we are going to have to figure out as a society and as professional organizations is whether those additional costs merit the very slight increases in polyp detection rate," said Dr. Cash. "We also need to figure out why the colorectal cancer incidence 3 years after index colonoscopies with anesthesia providers is slightly higher," he said.

Dr. Cash had no financial conflicts to disclose.

CHICAGO – Significantly more polyps were detected during colonoscopies when an anesthesiologist was present, compared with colonoscopies without an anesthesiologist, based on data from more than 4.5 million index colonoscopies. The findings were presented at the annual Digestive Disease Week.

Use of an anesthesiologist during colonoscopy has been associated with improved patient and provider satisfaction, but the diagnostic impact on polyp detection has not been well studied, said Dr. Brooks D. Cash of the National Naval Medical Center in Bethesda, Md.

The report "represents one of the first products of the new AGA [American Gastroenterological Association] Digestive Health Outcomes Registry," said Dr. Cash. "It has become increasingly important to have registries that look at quality and effectiveness of what we do as gastroenterologists," he said.

In this study, Dr. Cash and colleagues reviewed data from 4,539,547 index colonoscopies performed between 2001 and 2010. Based on coding data, approximately one-third of the colonoscopies involved an anesthesiologist.

Overall, the polyp detection rate was 37.7% for procedures with an anesthesiologist present, compared with 37% in procedures without an anesthesiologist. Because of the large numbers in the study, this difference was statistically significant (P less than .05).

In addition, significantly more individuals were diagnosed with colorectal cancer within 3 years of the index colonoscopy with an anesthesiologist present than without an anesthesiologist (1.97% vs. 1.71%).

Among men, the polyp detection rate was 43.18% with an anesthesiologist and 43.08% without an anesthesiologist. Among women, these rates were 33.17% and 31.95%, respectively. The differences were significant for both sexes.

The differences in colorectal cancer diagnosis after 3 years also remained significant by sex, the researchers noted. Among men, 2.12% of those who had an anesthesiologist present for their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.93% of those without an anesthesiologist present. Among women, 1.84% of those who had an anesthesiologist present at their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.54% of those without an anesthesiologist present.

The trends held constant for age as well as sex: Both polyp detection and colon cancer incidence after 3 years were slightly higher when an anesthesiologist was present for patients aged younger than 65 years and for those aged 65 years and older.

The study is important because there are significant costs – up to $700 per case – when an anesthesiologist is involved in a colonoscopy, although the cost varies by region, Dr. Cash said.

The use of anesthesiologists for colonoscopies began with comorbid patients who had a higher risk of moderate sedation complications, Dr. Cash said. "We have seen that the use of anesthesiologists has become more common, even for patients who are at average risk," he noted.

"What we are going to have to figure out as a society and as professional organizations is whether those additional costs merit the very slight increases in polyp detection rate," said Dr. Cash. "We also need to figure out why the colorectal cancer incidence 3 years after index colonoscopies with anesthesia providers is slightly higher," he said.

Dr. Cash had no financial conflicts to disclose.

CHICAGO – Significantly more polyps were detected during colonoscopies when an anesthesiologist was present, compared with colonoscopies without an anesthesiologist, based on data from more than 4.5 million index colonoscopies. The findings were presented at the annual Digestive Disease Week.

Use of an anesthesiologist during colonoscopy has been associated with improved patient and provider satisfaction, but the diagnostic impact on polyp detection has not been well studied, said Dr. Brooks D. Cash of the National Naval Medical Center in Bethesda, Md.

The report "represents one of the first products of the new AGA [American Gastroenterological Association] Digestive Health Outcomes Registry," said Dr. Cash. "It has become increasingly important to have registries that look at quality and effectiveness of what we do as gastroenterologists," he said.

In this study, Dr. Cash and colleagues reviewed data from 4,539,547 index colonoscopies performed between 2001 and 2010. Based on coding data, approximately one-third of the colonoscopies involved an anesthesiologist.

Overall, the polyp detection rate was 37.7% for procedures with an anesthesiologist present, compared with 37% in procedures without an anesthesiologist. Because of the large numbers in the study, this difference was statistically significant (P less than .05).

In addition, significantly more individuals were diagnosed with colorectal cancer within 3 years of the index colonoscopy with an anesthesiologist present than without an anesthesiologist (1.97% vs. 1.71%).

Among men, the polyp detection rate was 43.18% with an anesthesiologist and 43.08% without an anesthesiologist. Among women, these rates were 33.17% and 31.95%, respectively. The differences were significant for both sexes.

The differences in colorectal cancer diagnosis after 3 years also remained significant by sex, the researchers noted. Among men, 2.12% of those who had an anesthesiologist present for their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.93% of those without an anesthesiologist present. Among women, 1.84% of those who had an anesthesiologist present at their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.54% of those without an anesthesiologist present.

The trends held constant for age as well as sex: Both polyp detection and colon cancer incidence after 3 years were slightly higher when an anesthesiologist was present for patients aged younger than 65 years and for those aged 65 years and older.

The study is important because there are significant costs – up to $700 per case – when an anesthesiologist is involved in a colonoscopy, although the cost varies by region, Dr. Cash said.

The use of anesthesiologists for colonoscopies began with comorbid patients who had a higher risk of moderate sedation complications, Dr. Cash said. "We have seen that the use of anesthesiologists has become more common, even for patients who are at average risk," he noted.

"What we are going to have to figure out as a society and as professional organizations is whether those additional costs merit the very slight increases in polyp detection rate," said Dr. Cash. "We also need to figure out why the colorectal cancer incidence 3 years after index colonoscopies with anesthesia providers is slightly higher," he said.

Dr. Cash had no financial conflicts to disclose.

ATLANTA – Influenza vaccine should be given to persons with less severe egg allergies, as long as certain conditions are observed, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 23 meeting.

People with a less severe allergy were defined as "individuals who have experienced only hives following exposure to egg." Flu vaccination information for persons at risk for more severe reactions will be handled differently, said ACIP chair Dr. Carol Baker, who is professor of pediatrics, molecular virology, and microbiology at the Baylor College of Medicine, Houston.

The ACIP voted that individuals who have experienced only hives following exposure to egg should receive influenza vaccine with the following additional measures:

• As studies published to date involved use of TIV (trivalent inactivated vaccine), TIV rather than LAIV (live attenuated influenza vaccine) should be used.

• Vaccine should be administered by a health care provider who is familiar with the subject of egg allergy.

• Vaccine recipients should be observed for at least 30 minutes for signs of a reaction following administration of each vaccine dose.

The ACIP recommendation also notes that "other measures, such as dividing and administering the vaccine by a two-step approach and skin testing with vaccine, are not necessary." In addition, "egg allergy may be confirmed by a consistent medical history of adverse reactions to eggs and egg-containing foods, plus skin and/or blood testing for IgE antibodies to egg proteins," according to the recommendations.

During the discussion period, several ACIP members emphasized that the recommendations are for the upcoming 2011-2012 flu season.

In a separate vote, the ACIP voted to accept the virus strains for the upcoming season, which are the same as last year: A/California/7/2009 (H1N1-like), A/Perth/16/2009 (H3N2-like), and B/Brisbane/60/2008-like.

"We will be making note of the new intradermal vaccine, which is proposed to be an alternative" for the indicated age groups, Dr. Baker noted.

The vote on vaccine strains also included the recommendation for influenza vaccine in children aged 6 months through 8 years. For this age group, children who received at least one dose of vaccine during the 2010-2011 flu season should have one dose this year. Children in this age group who are receiving their first flu vaccine in 2011-2012, or whose vaccination status is unknown, should receive two doses at least 4 weeks apart.

The ACIP also voted to include a footnote stating that children aged 6 months through 8 years who received at least one dose of flu vaccine prior to the 2010-2011 season should receive one dose this season.

The ACIP recommendations were based on data presented by Dr. John M. Kelso, an allergist and immunologist at the Scripps Clinic in San Diego, Calif. Dr. Kelso and members of the Clinical Immunization Safety Assessment (CISA) Network Hypersensitivity Working Group reviewed data from 17 studies, including more that 2,600 egg-allergic persons, most of whom were children, who showed no serious reactions (such as respiratory distress or hypertension) and a low rate of minor reactions (such as hives and wheezing).

"It is very likely that there’s just not enough ovalbumin in the vaccine to cause a problem," Dr. Kelso said.

Although specific recommendations for the amount of ovalbumin in flu vaccines were cut from the ACIP recommendations, Dr. Kelso noted that the studies he reviewed showed no serious reactions at doses up to 0.7 mcg per 0.5 mL of vaccine.

None of the presenters reported any relevant financial disclosures.

ATLANTA – Influenza vaccine should be given to persons with less severe egg allergies, as long as certain conditions are observed, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 23 meeting.

People with a less severe allergy were defined as "individuals who have experienced only hives following exposure to egg." Flu vaccination information for persons at risk for more severe reactions will be handled differently, said ACIP chair Dr. Carol Baker, who is professor of pediatrics, molecular virology, and microbiology at the Baylor College of Medicine, Houston.

The ACIP voted that individuals who have experienced only hives following exposure to egg should receive influenza vaccine with the following additional measures:

• As studies published to date involved use of TIV (trivalent inactivated vaccine), TIV rather than LAIV (live attenuated influenza vaccine) should be used.

• Vaccine should be administered by a health care provider who is familiar with the subject of egg allergy.

• Vaccine recipients should be observed for at least 30 minutes for signs of a reaction following administration of each vaccine dose.

The ACIP recommendation also notes that "other measures, such as dividing and administering the vaccine by a two-step approach and skin testing with vaccine, are not necessary." In addition, "egg allergy may be confirmed by a consistent medical history of adverse reactions to eggs and egg-containing foods, plus skin and/or blood testing for IgE antibodies to egg proteins," according to the recommendations.

During the discussion period, several ACIP members emphasized that the recommendations are for the upcoming 2011-2012 flu season.

In a separate vote, the ACIP voted to accept the virus strains for the upcoming season, which are the same as last year: A/California/7/2009 (H1N1-like), A/Perth/16/2009 (H3N2-like), and B/Brisbane/60/2008-like.

"We will be making note of the new intradermal vaccine, which is proposed to be an alternative" for the indicated age groups, Dr. Baker noted.

The vote on vaccine strains also included the recommendation for influenza vaccine in children aged 6 months through 8 years. For this age group, children who received at least one dose of vaccine during the 2010-2011 flu season should have one dose this year. Children in this age group who are receiving their first flu vaccine in 2011-2012, or whose vaccination status is unknown, should receive two doses at least 4 weeks apart.

The ACIP also voted to include a footnote stating that children aged 6 months through 8 years who received at least one dose of flu vaccine prior to the 2010-2011 season should receive one dose this season.

The ACIP recommendations were based on data presented by Dr. John M. Kelso, an allergist and immunologist at the Scripps Clinic in San Diego, Calif. Dr. Kelso and members of the Clinical Immunization Safety Assessment (CISA) Network Hypersensitivity Working Group reviewed data from 17 studies, including more that 2,600 egg-allergic persons, most of whom were children, who showed no serious reactions (such as respiratory distress or hypertension) and a low rate of minor reactions (such as hives and wheezing).

"It is very likely that there’s just not enough ovalbumin in the vaccine to cause a problem," Dr. Kelso said.

Although specific recommendations for the amount of ovalbumin in flu vaccines were cut from the ACIP recommendations, Dr. Kelso noted that the studies he reviewed showed no serious reactions at doses up to 0.7 mcg per 0.5 mL of vaccine.

None of the presenters reported any relevant financial disclosures.

ATLANTA – Influenza vaccine should be given to persons with less severe egg allergies, as long as certain conditions are observed, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 23 meeting.

People with a less severe allergy were defined as "individuals who have experienced only hives following exposure to egg." Flu vaccination information for persons at risk for more severe reactions will be handled differently, said ACIP chair Dr. Carol Baker, who is professor of pediatrics, molecular virology, and microbiology at the Baylor College of Medicine, Houston.

The ACIP voted that individuals who have experienced only hives following exposure to egg should receive influenza vaccine with the following additional measures:

• As studies published to date involved use of TIV (trivalent inactivated vaccine), TIV rather than LAIV (live attenuated influenza vaccine) should be used.

• Vaccine should be administered by a health care provider who is familiar with the subject of egg allergy.

• Vaccine recipients should be observed for at least 30 minutes for signs of a reaction following administration of each vaccine dose.

The ACIP recommendation also notes that "other measures, such as dividing and administering the vaccine by a two-step approach and skin testing with vaccine, are not necessary." In addition, "egg allergy may be confirmed by a consistent medical history of adverse reactions to eggs and egg-containing foods, plus skin and/or blood testing for IgE antibodies to egg proteins," according to the recommendations.

During the discussion period, several ACIP members emphasized that the recommendations are for the upcoming 2011-2012 flu season.

In a separate vote, the ACIP voted to accept the virus strains for the upcoming season, which are the same as last year: A/California/7/2009 (H1N1-like), A/Perth/16/2009 (H3N2-like), and B/Brisbane/60/2008-like.

"We will be making note of the new intradermal vaccine, which is proposed to be an alternative" for the indicated age groups, Dr. Baker noted.

The vote on vaccine strains also included the recommendation for influenza vaccine in children aged 6 months through 8 years. For this age group, children who received at least one dose of vaccine during the 2010-2011 flu season should have one dose this year. Children in this age group who are receiving their first flu vaccine in 2011-2012, or whose vaccination status is unknown, should receive two doses at least 4 weeks apart.

The ACIP also voted to include a footnote stating that children aged 6 months through 8 years who received at least one dose of flu vaccine prior to the 2010-2011 season should receive one dose this season.

The ACIP recommendations were based on data presented by Dr. John M. Kelso, an allergist and immunologist at the Scripps Clinic in San Diego, Calif. Dr. Kelso and members of the Clinical Immunization Safety Assessment (CISA) Network Hypersensitivity Working Group reviewed data from 17 studies, including more that 2,600 egg-allergic persons, most of whom were children, who showed no serious reactions (such as respiratory distress or hypertension) and a low rate of minor reactions (such as hives and wheezing).

"It is very likely that there’s just not enough ovalbumin in the vaccine to cause a problem," Dr. Kelso said.

Although specific recommendations for the amount of ovalbumin in flu vaccines were cut from the ACIP recommendations, Dr. Kelso noted that the studies he reviewed showed no serious reactions at doses up to 0.7 mcg per 0.5 mL of vaccine.

None of the presenters reported any relevant financial disclosures.

ATLANTA – Influenza vaccine should be given to persons with less severe egg allergies, as long as certain conditions are observed, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 23 meeting.

People with a less severe allergy were defined as "individuals who have experienced only hives following exposure to egg." Flu vaccination information for persons at risk for more severe reactions will be handled differently, said ACIP chair Dr. Carol Baker, who is professor of pediatrics, molecular virology, and microbiology at the Baylor College of Medicine, Houston.

The ACIP voted that individuals who have experienced only hives following exposure to egg should receive influenza vaccine with the following additional measures:

• As studies published to date involved use of TIV (trivalent inactivated vaccine), TIV rather than LAIV (live attenuated influenza vaccine) should be used.

• Vaccine should be administered by a health care provider who is familiar with the subject of egg allergy.

• Vaccine recipients should be observed for at least 30 minutes for signs of a reaction following administration of each vaccine dose.

The ACIP recommendation also notes that "other measures, such as dividing and administering the vaccine by a two-step approach and skin testing with vaccine, are not necessary." In addition, "egg allergy may be confirmed by a consistent medical history of adverse reactions to eggs and egg-containing foods, plus skin and/or blood testing for IgE antibodies to egg proteins," according to the recommendations.

During the discussion period, several ACIP members emphasized that the recommendations are for the upcoming 2011-2012 flu season.

In a separate vote, the ACIP voted to accept the virus strains for the upcoming season, which are the same as last year: A/California/7/2009 (H1N1-like), A/Perth/16/2009 (H3N2-like), and B/Brisbane/60/2008-like.

"We will be making note of the new intradermal vaccine, which is proposed to be an alternative" for the indicated age groups, Dr. Baker noted.

The vote on vaccine strains also included the recommendation for influenza vaccine in children aged 6 months through 8 years. For this age group, children who received at least one dose of vaccine during the 2010-2011 flu season should have one dose this year. Children in this age group who are receiving their first flu vaccine in 2011-2012, or whose vaccination status is unknown, should receive two doses at least 4 weeks apart.

The ACIP also voted to include a footnote stating that children aged 6 months through 8 years who received at least one dose of flu vaccine prior to the 2010-2011 season should receive one dose this season.

The ACIP recommendations were based on data presented by Dr. John M. Kelso, an allergist and immunologist at the Scripps Clinic in San Diego, Calif. Dr. Kelso and members of the Clinical Immunization Safety Assessment (CISA) Network Hypersensitivity Working Group reviewed data from 17 studies, including more that 2,600 egg-allergic persons, most of whom were children, who showed no serious reactions (such as respiratory distress or hypertension) and a low rate of minor reactions (such as hives and wheezing).

"It is very likely that there’s just not enough ovalbumin in the vaccine to cause a problem," Dr. Kelso said.

Although specific recommendations for the amount of ovalbumin in flu vaccines were cut from the ACIP recommendations, Dr. Kelso noted that the studies he reviewed showed no serious reactions at doses up to 0.7 mcg per 0.5 mL of vaccine.

None of the presenters reported any relevant financial disclosures.

ATLANTA – Influenza vaccine should be given to persons with less severe egg allergies, as long as certain conditions are observed, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 23 meeting.

People with a less severe allergy were defined as "individuals who have experienced only hives following exposure to egg." Flu vaccination information for persons at risk for more severe reactions will be handled differently, said ACIP chair Dr. Carol Baker, who is professor of pediatrics, molecular virology, and microbiology at the Baylor College of Medicine, Houston.

The ACIP voted that individuals who have experienced only hives following exposure to egg should receive influenza vaccine with the following additional measures:

• As studies published to date involved use of TIV (trivalent inactivated vaccine), TIV rather than LAIV (live attenuated influenza vaccine) should be used.

• Vaccine should be administered by a health care provider who is familiar with the subject of egg allergy.

• Vaccine recipients should be observed for at least 30 minutes for signs of a reaction following administration of each vaccine dose.

The ACIP recommendation also notes that "other measures, such as dividing and administering the vaccine by a two-step approach and skin testing with vaccine, are not necessary." In addition, "egg allergy may be confirmed by a consistent medical history of adverse reactions to eggs and egg-containing foods, plus skin and/or blood testing for IgE antibodies to egg proteins," according to the recommendations.

During the discussion period, several ACIP members emphasized that the recommendations are for the upcoming 2011-2012 flu season.

In a separate vote, the ACIP voted to accept the virus strains for the upcoming season, which are the same as last year: A/California/7/2009 (H1N1-like), A/Perth/16/2009 (H3N2-like), and B/Brisbane/60/2008-like.

"We will be making note of the new intradermal vaccine, which is proposed to be an alternative" for the indicated age groups, Dr. Baker noted.

The vote on vaccine strains also included the recommendation for influenza vaccine in children aged 6 months through 8 years. For this age group, children who received at least one dose of vaccine during the 2010-2011 flu season should have one dose this year. Children in this age group who are receiving their first flu vaccine in 2011-2012, or whose vaccination status is unknown, should receive two doses at least 4 weeks apart.

The ACIP also voted to include a footnote stating that children aged 6 months through 8 years who received at least one dose of flu vaccine prior to the 2010-2011 season should receive one dose this season.

The ACIP recommendations were based on data presented by Dr. John M. Kelso, an allergist and immunologist at the Scripps Clinic in San Diego, Calif. Dr. Kelso and members of the Clinical Immunization Safety Assessment (CISA) Network Hypersensitivity Working Group reviewed data from 17 studies, including more that 2,600 egg-allergic persons, most of whom were children, who showed no serious reactions (such as respiratory distress or hypertension) and a low rate of minor reactions (such as hives and wheezing).

"It is very likely that there’s just not enough ovalbumin in the vaccine to cause a problem," Dr. Kelso said.

Although specific recommendations for the amount of ovalbumin in flu vaccines were cut from the ACIP recommendations, Dr. Kelso noted that the studies he reviewed showed no serious reactions at doses up to 0.7 mcg per 0.5 mL of vaccine.

None of the presenters reported any relevant financial disclosures.

ATLANTA – Influenza vaccine should be given to persons with less severe egg allergies, as long as certain conditions are observed, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 23 meeting.

People with a less severe allergy were defined as "individuals who have experienced only hives following exposure to egg." Flu vaccination information for persons at risk for more severe reactions will be handled differently, said ACIP chair Dr. Carol Baker, who is professor of pediatrics, molecular virology, and microbiology at the Baylor College of Medicine, Houston.

The ACIP voted that individuals who have experienced only hives following exposure to egg should receive influenza vaccine with the following additional measures:

• As studies published to date involved use of TIV (trivalent inactivated vaccine), TIV rather than LAIV (live attenuated influenza vaccine) should be used.

• Vaccine should be administered by a health care provider who is familiar with the subject of egg allergy.

• Vaccine recipients should be observed for at least 30 minutes for signs of a reaction following administration of each vaccine dose.

The ACIP recommendation also notes that "other measures, such as dividing and administering the vaccine by a two-step approach and skin testing with vaccine, are not necessary." In addition, "egg allergy may be confirmed by a consistent medical history of adverse reactions to eggs and egg-containing foods, plus skin and/or blood testing for IgE antibodies to egg proteins," according to the recommendations.

During the discussion period, several ACIP members emphasized that the recommendations are for the upcoming 2011-2012 flu season.

In a separate vote, the ACIP voted to accept the virus strains for the upcoming season, which are the same as last year: A/California/7/2009 (H1N1-like), A/Perth/16/2009 (H3N2-like), and B/Brisbane/60/2008-like.

"We will be making note of the new intradermal vaccine, which is proposed to be an alternative" for the indicated age groups, Dr. Baker noted.

The vote on vaccine strains also included the recommendation for influenza vaccine in children aged 6 months through 8 years. For this age group, children who received at least one dose of vaccine during the 2010-2011 flu season should have one dose this year. Children in this age group who are receiving their first flu vaccine in 2011-2012, or whose vaccination status is unknown, should receive two doses at least 4 weeks apart.

The ACIP also voted to include a footnote stating that children aged 6 months through 8 years who received at least one dose of flu vaccine prior to the 2010-2011 season should receive one dose this season.

The ACIP recommendations were based on data presented by Dr. John M. Kelso, an allergist and immunologist at the Scripps Clinic in San Diego, Calif. Dr. Kelso and members of the Clinical Immunization Safety Assessment (CISA) Network Hypersensitivity Working Group reviewed data from 17 studies, including more that 2,600 egg-allergic persons, most of whom were children, who showed no serious reactions (such as respiratory distress or hypertension) and a low rate of minor reactions (such as hives and wheezing).

"It is very likely that there’s just not enough ovalbumin in the vaccine to cause a problem," Dr. Kelso said.

Although specific recommendations for the amount of ovalbumin in flu vaccines were cut from the ACIP recommendations, Dr. Kelso noted that the studies he reviewed showed no serious reactions at doses up to 0.7 mcg per 0.5 mL of vaccine.

None of the presenters reported any relevant financial disclosures.

ATLANTA – Hepatitis B vaccination of adults with diabetes could potentially prevent more than 5,000 hepatitis B infections, according to data presented at the June 23 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

CDC data from 2009-2010 showed an overall incidence of hepatitis B in adults with diabetes of 2.1 per 100,000, compared with 1.1 per 100,000 for adults without diabetes, and this difference was statistically significant, said Meredith Reilly of the CDC’s Division of Viral Hepatitis.

©pressdigital/istockphoto.com

Documentation of multiple hepatitis B outbreaks among adults with diabetes, mostly in long-term care facilities, prompted the ACIP hepatitis working group to consider the issue, noted Dr. Mark Sawyer of the University of California, San Diego, who chaired the working group.

Two potential options for ACIP recommendations for hepatitis B vaccination of adults with diabetes were presented, in anticipation of a possible vote on the matter at the October ACIP meeting.

The two recommendations include two categories, explained Dr. Trudy Murphy of the CDC, who presented the options. Category A applies to all persons in an age or risk group, and uses words such as "should," she said. Category B recommendations encourage individual clinical decision making and include words such as "may."

The proposed Option 1/Category A recommendation calls for the hepatitis B vaccination for all unvaccinated adults with diabetes who are younger than 60 years, and the hepatitis B vaccine series should be completed as soon as feasible after a diagnosis of diabetes. The proposed Option 1/Category B recommendation states that decisions to vaccinate adults with diabetes who are aged 60 years and older should be made based on the clinical judgment of the health care provider, considering the various risks and benefits.

"Option 1 was preferred by a majority of the working group," said Dr. Murphy. However, a minority still preferred Option 2.

The proposed Option 2/Category A recommendation calls for the hepatitis B vaccination of all unvaccinated adults with diabetes regardless of age, and the series should be completed as soon as feasible after a diabetes diagnosis.

The proposed Option 2/Category B recommendation has several elements. First, it calls for individual clinical decision making on the value of vaccinating frail, elderly adults who have diabetes. In addition, the proposed category B recommendation states that "revaccination with three additional doses of hepatitis B vaccine generally increases the proportion of [nonresponding] adults who achieve a protective level of antibody to hepatitis B surface antigen." And, for adults who might have a reduced response to the initial vaccine series, revaccination would be medically appropriate. However, "if revaccination is planned when a protective level is not achieved, testing for anti-HBs [surface antigen] is recommended 1-2 months after completion of the initial hepatitis B series," according to the proposed Category B recommendation for Option 2.

Dr. Murphy added that final recommendations could potentially contain "remarks," with language stating that available data do not confirm an advantage to any specific hepatitis B vaccine, dosage, or approved schedule for adults with diabetes, and that no additional hepatitis B vaccination is currently recommended for adults with diabetes who received a complete series of hepatitis B vaccine at any time in the past.

Option 1 was preferred by a majority of the working group, in part because it recommends vaccination for the age groups that could achieve the highest rates of protection, Dr. Murphy said. However, a minority of the working group favored Option 2, in part because of its simplicity.

Simplicity was appealing to several ACIP liaisons who commented during a discussion period.

Dr. William Schaffner of the National Foundation for Infectious Diseases was emphatically in favor of Option 2 because it would simplify the vaccination process for clinicians. "If you want to immunize diabetics, immunize them," rather than make distinctions based on age, he said. He also noted that Option 1 would eliminate many older patients in nursing homes from vaccination.

Dr. Sandra Fryhofer of the American College of Physicians added her support for Option 2. "The reason why we are talking about this is outbreaks in the nursing home," she said.

Both recommendation options were based in part on cost-effectiveness data presented by Thomas Hoerger, Ph.D., of RTI International. Dr. Hoerger and colleagues worked with the CDC to develop a cost-effectiveness model for hepatitis B vaccination of adults with diabetes. Dr. Hoerger presented data showing that vaccination does provide protection against hepatitis B in adults with diabetes, although the efficacy declines with age. The cost per QALY (quality-adjusted life year) for vaccination of adults aged 20-59 years was $58, 762, and the cost per QALY for vaccination of all adults with diabetes aged 20 years and older was $159, 633.

The working group plans to present additional data at the October 2011 ACIP meeting, Dr. Murphy said.

None of the presenters had any relevant financial disclosures.

ATLANTA – Hepatitis B vaccination of adults with diabetes could potentially prevent more than 5,000 hepatitis B infections, according to data presented at the June 23 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

CDC data from 2009-2010 showed an overall incidence of hepatitis B in adults with diabetes of 2.1 per 100,000, compared with 1.1 per 100,000 for adults without diabetes, and this difference was statistically significant, said Meredith Reilly of the CDC’s Division of Viral Hepatitis.

©pressdigital/istockphoto.com

Documentation of multiple hepatitis B outbreaks among adults with diabetes, mostly in long-term care facilities, prompted the ACIP hepatitis working group to consider the issue, noted Dr. Mark Sawyer of the University of California, San Diego, who chaired the working group.

Two potential options for ACIP recommendations for hepatitis B vaccination of adults with diabetes were presented, in anticipation of a possible vote on the matter at the October ACIP meeting.

The two recommendations include two categories, explained Dr. Trudy Murphy of the CDC, who presented the options. Category A applies to all persons in an age or risk group, and uses words such as "should," she said. Category B recommendations encourage individual clinical decision making and include words such as "may."

The proposed Option 1/Category A recommendation calls for the hepatitis B vaccination for all unvaccinated adults with diabetes who are younger than 60 years, and the hepatitis B vaccine series should be completed as soon as feasible after a diagnosis of diabetes. The proposed Option 1/Category B recommendation states that decisions to vaccinate adults with diabetes who are aged 60 years and older should be made based on the clinical judgment of the health care provider, considering the various risks and benefits.

"Option 1 was preferred by a majority of the working group," said Dr. Murphy. However, a minority still preferred Option 2.

The proposed Option 2/Category A recommendation calls for the hepatitis B vaccination of all unvaccinated adults with diabetes regardless of age, and the series should be completed as soon as feasible after a diabetes diagnosis.

The proposed Option 2/Category B recommendation has several elements. First, it calls for individual clinical decision making on the value of vaccinating frail, elderly adults who have diabetes. In addition, the proposed category B recommendation states that "revaccination with three additional doses of hepatitis B vaccine generally increases the proportion of [nonresponding] adults who achieve a protective level of antibody to hepatitis B surface antigen." And, for adults who might have a reduced response to the initial vaccine series, revaccination would be medically appropriate. However, "if revaccination is planned when a protective level is not achieved, testing for anti-HBs [surface antigen] is recommended 1-2 months after completion of the initial hepatitis B series," according to the proposed Category B recommendation for Option 2.

Dr. Murphy added that final recommendations could potentially contain "remarks," with language stating that available data do not confirm an advantage to any specific hepatitis B vaccine, dosage, or approved schedule for adults with diabetes, and that no additional hepatitis B vaccination is currently recommended for adults with diabetes who received a complete series of hepatitis B vaccine at any time in the past.

Option 1 was preferred by a majority of the working group, in part because it recommends vaccination for the age groups that could achieve the highest rates of protection, Dr. Murphy said. However, a minority of the working group favored Option 2, in part because of its simplicity.

Simplicity was appealing to several ACIP liaisons who commented during a discussion period.

Dr. William Schaffner of the National Foundation for Infectious Diseases was emphatically in favor of Option 2 because it would simplify the vaccination process for clinicians. "If you want to immunize diabetics, immunize them," rather than make distinctions based on age, he said. He also noted that Option 1 would eliminate many older patients in nursing homes from vaccination.

Dr. Sandra Fryhofer of the American College of Physicians added her support for Option 2. "The reason why we are talking about this is outbreaks in the nursing home," she said.

Both recommendation options were based in part on cost-effectiveness data presented by Thomas Hoerger, Ph.D., of RTI International. Dr. Hoerger and colleagues worked with the CDC to develop a cost-effectiveness model for hepatitis B vaccination of adults with diabetes. Dr. Hoerger presented data showing that vaccination does provide protection against hepatitis B in adults with diabetes, although the efficacy declines with age. The cost per QALY (quality-adjusted life year) for vaccination of adults aged 20-59 years was $58, 762, and the cost per QALY for vaccination of all adults with diabetes aged 20 years and older was $159, 633.

The working group plans to present additional data at the October 2011 ACIP meeting, Dr. Murphy said.

None of the presenters had any relevant financial disclosures.

ATLANTA – Hepatitis B vaccination of adults with diabetes could potentially prevent more than 5,000 hepatitis B infections, according to data presented at the June 23 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

CDC data from 2009-2010 showed an overall incidence of hepatitis B in adults with diabetes of 2.1 per 100,000, compared with 1.1 per 100,000 for adults without diabetes, and this difference was statistically significant, said Meredith Reilly of the CDC’s Division of Viral Hepatitis.

©pressdigital/istockphoto.com

Documentation of multiple hepatitis B outbreaks among adults with diabetes, mostly in long-term care facilities, prompted the ACIP hepatitis working group to consider the issue, noted Dr. Mark Sawyer of the University of California, San Diego, who chaired the working group.

Two potential options for ACIP recommendations for hepatitis B vaccination of adults with diabetes were presented, in anticipation of a possible vote on the matter at the October ACIP meeting.

The two recommendations include two categories, explained Dr. Trudy Murphy of the CDC, who presented the options. Category A applies to all persons in an age or risk group, and uses words such as "should," she said. Category B recommendations encourage individual clinical decision making and include words such as "may."

The proposed Option 1/Category A recommendation calls for the hepatitis B vaccination for all unvaccinated adults with diabetes who are younger than 60 years, and the hepatitis B vaccine series should be completed as soon as feasible after a diagnosis of diabetes. The proposed Option 1/Category B recommendation states that decisions to vaccinate adults with diabetes who are aged 60 years and older should be made based on the clinical judgment of the health care provider, considering the various risks and benefits.

"Option 1 was preferred by a majority of the working group," said Dr. Murphy. However, a minority still preferred Option 2.

The proposed Option 2/Category A recommendation calls for the hepatitis B vaccination of all unvaccinated adults with diabetes regardless of age, and the series should be completed as soon as feasible after a diabetes diagnosis.

The proposed Option 2/Category B recommendation has several elements. First, it calls for individual clinical decision making on the value of vaccinating frail, elderly adults who have diabetes. In addition, the proposed category B recommendation states that "revaccination with three additional doses of hepatitis B vaccine generally increases the proportion of [nonresponding] adults who achieve a protective level of antibody to hepatitis B surface antigen." And, for adults who might have a reduced response to the initial vaccine series, revaccination would be medically appropriate. However, "if revaccination is planned when a protective level is not achieved, testing for anti-HBs [surface antigen] is recommended 1-2 months after completion of the initial hepatitis B series," according to the proposed Category B recommendation for Option 2.

Dr. Murphy added that final recommendations could potentially contain "remarks," with language stating that available data do not confirm an advantage to any specific hepatitis B vaccine, dosage, or approved schedule for adults with diabetes, and that no additional hepatitis B vaccination is currently recommended for adults with diabetes who received a complete series of hepatitis B vaccine at any time in the past.

Option 1 was preferred by a majority of the working group, in part because it recommends vaccination for the age groups that could achieve the highest rates of protection, Dr. Murphy said. However, a minority of the working group favored Option 2, in part because of its simplicity.

Simplicity was appealing to several ACIP liaisons who commented during a discussion period.

Dr. William Schaffner of the National Foundation for Infectious Diseases was emphatically in favor of Option 2 because it would simplify the vaccination process for clinicians. "If you want to immunize diabetics, immunize them," rather than make distinctions based on age, he said. He also noted that Option 1 would eliminate many older patients in nursing homes from vaccination.

Dr. Sandra Fryhofer of the American College of Physicians added her support for Option 2. "The reason why we are talking about this is outbreaks in the nursing home," she said.

Both recommendation options were based in part on cost-effectiveness data presented by Thomas Hoerger, Ph.D., of RTI International. Dr. Hoerger and colleagues worked with the CDC to develop a cost-effectiveness model for hepatitis B vaccination of adults with diabetes. Dr. Hoerger presented data showing that vaccination does provide protection against hepatitis B in adults with diabetes, although the efficacy declines with age. The cost per QALY (quality-adjusted life year) for vaccination of adults aged 20-59 years was $58, 762, and the cost per QALY for vaccination of all adults with diabetes aged 20 years and older was $159, 633.

The working group plans to present additional data at the October 2011 ACIP meeting, Dr. Murphy said.

None of the presenters had any relevant financial disclosures.

ATLANTA – Hepatitis B vaccination of adults with diabetes could potentially prevent more than 5,000 hepatitis B infections, according to data presented at the June 23 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

CDC data from 2009-2010 showed an overall incidence of hepatitis B in adults with diabetes of 2.1 per 100,000, compared with 1.1 per 100,000 for adults without diabetes, and this difference was statistically significant, said Meredith Reilly of the CDC’s Division of Viral Hepatitis.

©pressdigital/istockphoto.com

Documentation of multiple hepatitis B outbreaks among adults with diabetes, mostly in long-term care facilities, prompted the ACIP hepatitis working group to consider the issue, noted Dr. Mark Sawyer of the University of California, San Diego, who chaired the working group.

Two potential options for ACIP recommendations for hepatitis B vaccination of adults with diabetes were presented, in anticipation of a possible vote on the matter at the October ACIP meeting.

The two recommendations include two categories, explained Dr. Trudy Murphy of the CDC, who presented the options. Category A applies to all persons in an age or risk group, and uses words such as "should," she said. Category B recommendations encourage individual clinical decision making and include words such as "may."

The proposed Option 1/Category A recommendation calls for the hepatitis B vaccination for all unvaccinated adults with diabetes who are younger than 60 years, and the hepatitis B vaccine series should be completed as soon as feasible after a diagnosis of diabetes. The proposed Option 1/Category B recommendation states that decisions to vaccinate adults with diabetes who are aged 60 years and older should be made based on the clinical judgment of the health care provider, considering the various risks and benefits.

"Option 1 was preferred by a majority of the working group," said Dr. Murphy. However, a minority still preferred Option 2.

The proposed Option 2/Category A recommendation calls for the hepatitis B vaccination of all unvaccinated adults with diabetes regardless of age, and the series should be completed as soon as feasible after a diabetes diagnosis.

The proposed Option 2/Category B recommendation has several elements. First, it calls for individual clinical decision making on the value of vaccinating frail, elderly adults who have diabetes. In addition, the proposed category B recommendation states that "revaccination with three additional doses of hepatitis B vaccine generally increases the proportion of [nonresponding] adults who achieve a protective level of antibody to hepatitis B surface antigen." And, for adults who might have a reduced response to the initial vaccine series, revaccination would be medically appropriate. However, "if revaccination is planned when a protective level is not achieved, testing for anti-HBs [surface antigen] is recommended 1-2 months after completion of the initial hepatitis B series," according to the proposed Category B recommendation for Option 2.

Dr. Murphy added that final recommendations could potentially contain "remarks," with language stating that available data do not confirm an advantage to any specific hepatitis B vaccine, dosage, or approved schedule for adults with diabetes, and that no additional hepatitis B vaccination is currently recommended for adults with diabetes who received a complete series of hepatitis B vaccine at any time in the past.

Option 1 was preferred by a majority of the working group, in part because it recommends vaccination for the age groups that could achieve the highest rates of protection, Dr. Murphy said. However, a minority of the working group favored Option 2, in part because of its simplicity.

Simplicity was appealing to several ACIP liaisons who commented during a discussion period.

Dr. William Schaffner of the National Foundation for Infectious Diseases was emphatically in favor of Option 2 because it would simplify the vaccination process for clinicians. "If you want to immunize diabetics, immunize them," rather than make distinctions based on age, he said. He also noted that Option 1 would eliminate many older patients in nursing homes from vaccination.

Dr. Sandra Fryhofer of the American College of Physicians added her support for Option 2. "The reason why we are talking about this is outbreaks in the nursing home," she said.

Both recommendation options were based in part on cost-effectiveness data presented by Thomas Hoerger, Ph.D., of RTI International. Dr. Hoerger and colleagues worked with the CDC to develop a cost-effectiveness model for hepatitis B vaccination of adults with diabetes. Dr. Hoerger presented data showing that vaccination does provide protection against hepatitis B in adults with diabetes, although the efficacy declines with age. The cost per QALY (quality-adjusted life year) for vaccination of adults aged 20-59 years was $58, 762, and the cost per QALY for vaccination of all adults with diabetes aged 20 years and older was $159, 633.

The working group plans to present additional data at the October 2011 ACIP meeting, Dr. Murphy said.

None of the presenters had any relevant financial disclosures.

ATLANTA – Hepatitis B vaccination of adults with diabetes could potentially prevent more than 5,000 hepatitis B infections, according to data presented at the June 23 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

CDC data from 2009-2010 showed an overall incidence of hepatitis B in adults with diabetes of 2.1 per 100,000, compared with 1.1 per 100,000 for adults without diabetes, and this difference was statistically significant, said Meredith Reilly of the CDC’s Division of Viral Hepatitis.

©pressdigital/istockphoto.com

Documentation of multiple hepatitis B outbreaks among adults with diabetes, mostly in long-term care facilities, prompted the ACIP hepatitis working group to consider the issue, noted Dr. Mark Sawyer of the University of California, San Diego, who chaired the working group.

Two potential options for ACIP recommendations for hepatitis B vaccination of adults with diabetes were presented, in anticipation of a possible vote on the matter at the October ACIP meeting.

The two recommendations include two categories, explained Dr. Trudy Murphy of the CDC, who presented the options. Category A applies to all persons in an age or risk group, and uses words such as "should," she said. Category B recommendations encourage individual clinical decision making and include words such as "may."

The proposed Option 1/Category A recommendation calls for the hepatitis B vaccination for all unvaccinated adults with diabetes who are younger than 60 years, and the hepatitis B vaccine series should be completed as soon as feasible after a diagnosis of diabetes. The proposed Option 1/Category B recommendation states that decisions to vaccinate adults with diabetes who are aged 60 years and older should be made based on the clinical judgment of the health care provider, considering the various risks and benefits.

"Option 1 was preferred by a majority of the working group," said Dr. Murphy. However, a minority still preferred Option 2.

The proposed Option 2/Category A recommendation calls for the hepatitis B vaccination of all unvaccinated adults with diabetes regardless of age, and the series should be completed as soon as feasible after a diabetes diagnosis.

The proposed Option 2/Category B recommendation has several elements. First, it calls for individual clinical decision making on the value of vaccinating frail, elderly adults who have diabetes. In addition, the proposed category B recommendation states that "revaccination with three additional doses of hepatitis B vaccine generally increases the proportion of [nonresponding] adults who achieve a protective level of antibody to hepatitis B surface antigen." And, for adults who might have a reduced response to the initial vaccine series, revaccination would be medically appropriate. However, "if revaccination is planned when a protective level is not achieved, testing for anti-HBs [surface antigen] is recommended 1-2 months after completion of the initial hepatitis B series," according to the proposed Category B recommendation for Option 2.

Dr. Murphy added that final recommendations could potentially contain "remarks," with language stating that available data do not confirm an advantage to any specific hepatitis B vaccine, dosage, or approved schedule for adults with diabetes, and that no additional hepatitis B vaccination is currently recommended for adults with diabetes who received a complete series of hepatitis B vaccine at any time in the past.

Option 1 was preferred by a majority of the working group, in part because it recommends vaccination for the age groups that could achieve the highest rates of protection, Dr. Murphy said. However, a minority of the working group favored Option 2, in part because of its simplicity.

Simplicity was appealing to several ACIP liaisons who commented during a discussion period.

Dr. William Schaffner of the National Foundation for Infectious Diseases was emphatically in favor of Option 2 because it would simplify the vaccination process for clinicians. "If you want to immunize diabetics, immunize them," rather than make distinctions based on age, he said. He also noted that Option 1 would eliminate many older patients in nursing homes from vaccination.

Dr. Sandra Fryhofer of the American College of Physicians added her support for Option 2. "The reason why we are talking about this is outbreaks in the nursing home," she said.

Both recommendation options were based in part on cost-effectiveness data presented by Thomas Hoerger, Ph.D., of RTI International. Dr. Hoerger and colleagues worked with the CDC to develop a cost-effectiveness model for hepatitis B vaccination of adults with diabetes. Dr. Hoerger presented data showing that vaccination does provide protection against hepatitis B in adults with diabetes, although the efficacy declines with age. The cost per QALY (quality-adjusted life year) for vaccination of adults aged 20-59 years was $58, 762, and the cost per QALY for vaccination of all adults with diabetes aged 20 years and older was $159, 633.

The working group plans to present additional data at the October 2011 ACIP meeting, Dr. Murphy said.

None of the presenters had any relevant financial disclosures.

ATLANTA – Hepatitis B vaccination of adults with diabetes could potentially prevent more than 5,000 hepatitis B infections, according to data presented at the June 23 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

CDC data from 2009-2010 showed an overall incidence of hepatitis B in adults with diabetes of 2.1 per 100,000, compared with 1.1 per 100,000 for adults without diabetes, and this difference was statistically significant, said Meredith Reilly of the CDC’s Division of Viral Hepatitis.

©pressdigital/istockphoto.com

Documentation of multiple hepatitis B outbreaks among adults with diabetes, mostly in long-term care facilities, prompted the ACIP hepatitis working group to consider the issue, noted Dr. Mark Sawyer of the University of California, San Diego, who chaired the working group.

Two potential options for ACIP recommendations for hepatitis B vaccination of adults with diabetes were presented, in anticipation of a possible vote on the matter at the October ACIP meeting.

The two recommendations include two categories, explained Dr. Trudy Murphy of the CDC, who presented the options. Category A applies to all persons in an age or risk group, and uses words such as "should," she said. Category B recommendations encourage individual clinical decision making and include words such as "may."

The proposed Option 1/Category A recommendation calls for the hepatitis B vaccination for all unvaccinated adults with diabetes who are younger than 60 years, and the hepatitis B vaccine series should be completed as soon as feasible after a diagnosis of diabetes. The proposed Option 1/Category B recommendation states that decisions to vaccinate adults with diabetes who are aged 60 years and older should be made based on the clinical judgment of the health care provider, considering the various risks and benefits.

"Option 1 was preferred by a majority of the working group," said Dr. Murphy. However, a minority still preferred Option 2.

The proposed Option 2/Category A recommendation calls for the hepatitis B vaccination of all unvaccinated adults with diabetes regardless of age, and the series should be completed as soon as feasible after a diabetes diagnosis.

The proposed Option 2/Category B recommendation has several elements. First, it calls for individual clinical decision making on the value of vaccinating frail, elderly adults who have diabetes. In addition, the proposed category B recommendation states that "revaccination with three additional doses of hepatitis B vaccine generally increases the proportion of [nonresponding] adults who achieve a protective level of antibody to hepatitis B surface antigen." And, for adults who might have a reduced response to the initial vaccine series, revaccination would be medically appropriate. However, "if revaccination is planned when a protective level is not achieved, testing for anti-HBs [surface antigen] is recommended 1-2 months after completion of the initial hepatitis B series," according to the proposed Category B recommendation for Option 2.

Dr. Murphy added that final recommendations could potentially contain "remarks," with language stating that available data do not confirm an advantage to any specific hepatitis B vaccine, dosage, or approved schedule for adults with diabetes, and that no additional hepatitis B vaccination is currently recommended for adults with diabetes who received a complete series of hepatitis B vaccine at any time in the past.

Option 1 was preferred by a majority of the working group, in part because it recommends vaccination for the age groups that could achieve the highest rates of protection, Dr. Murphy said. However, a minority of the working group favored Option 2, in part because of its simplicity.

Simplicity was appealing to several ACIP liaisons who commented during a discussion period.

Dr. William Schaffner of the National Foundation for Infectious Diseases was emphatically in favor of Option 2 because it would simplify the vaccination process for clinicians. "If you want to immunize diabetics, immunize them," rather than make distinctions based on age, he said. He also noted that Option 1 would eliminate many older patients in nursing homes from vaccination.

Dr. Sandra Fryhofer of the American College of Physicians added her support for Option 2. "The reason why we are talking about this is outbreaks in the nursing home," she said.

Both recommendation options were based in part on cost-effectiveness data presented by Thomas Hoerger, Ph.D., of RTI International. Dr. Hoerger and colleagues worked with the CDC to develop a cost-effectiveness model for hepatitis B vaccination of adults with diabetes. Dr. Hoerger presented data showing that vaccination does provide protection against hepatitis B in adults with diabetes, although the efficacy declines with age. The cost per QALY (quality-adjusted life year) for vaccination of adults aged 20-59 years was $58, 762, and the cost per QALY for vaccination of all adults with diabetes aged 20 years and older was $159, 633.

The working group plans to present additional data at the October 2011 ACIP meeting, Dr. Murphy said.

None of the presenters had any relevant financial disclosures.

ATLANTA – The Tdap vaccine should be given to pregnant women after 20 weeks’ gestation to help prevent pertussis in the mothers and their newborns, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

The ACIP also voted that in special situations in which a pregnant women who has not previously received Tdap is in need of a tetanus booster (for wound management or if it’s been more than 10 years since the previous Td), health care providers should administer Tdap during the third or late second trimester (after 20 weeks’ gestation). However, the language may be revised to allow for earlier vaccination for urgent wound management in women prior to 20 weeks’ gestation.

In addition, the ACIP recommended that pregnant women whose tetanus vaccination status is unknown or uncertain should received three vaccinations containing tetanus and reduced diphtheria toxoids during pregnancy. The recommended dosing schedule is 0, 4 weeks, and 6-12 months. Tdap should replace one dose of Td, preferably during the late second or third trimester.

As part of the same vote, the ACIP also voted to recommend "cocooning" (Tdap vaccination of adolescent and adult contacts of infants younger than 12 months) despite the lack of evidence for its effectiveness.

"The working group would never not recommend cocooning, but it is an insufficient national strategy to prevent pertussis morbidity and mortality for newborn infants," noted Dr. Jennifer Liang of the CDC, who presented data on behalf of the ACIP pertussis vaccine working group. Cocooning has been recommended since 2005, but available data show poor uptake and no evidence that cocooning programs are sustainable, she said.

The ACIP voted in favor of prenatal Tdap vaccination as preferable to postpartum vaccination when possible. "Postpartum vaccination is a suboptimal national strategy to prevent infant pertussis morbidity and mortality," said Dr. Liang. "Vaccinating pregnant women during the late second or early third trimester is acceptably safe for both mother and fetus."

Moving Tdap vaccination to the third trimester of pregnancy is the most cost-effective of several options to protect pregnant women and newborns against pertussis, said Garrett R. Beeler Asay, Ph.D., also of the CDC. Using a simulated birth cohort model of approximately 4 million infants, the cost per quality-of-life-year saved was $414,442 for vaccination during pregnancy, compared to $1,174,143 for postpartum vaccination.

The ACIP also voted to include the recommendations in the Vaccines for Children program, to state that adolescents who are pregnant would receive Tdap in the same manner as adult pregnant women.

Neither Dr. Liang nor Dr. Beeler Asay had any relevant financial disclosures.

ATLANTA – The Tdap vaccine should be given to pregnant women after 20 weeks’ gestation to help prevent pertussis in the mothers and their newborns, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

The ACIP also voted that in special situations in which a pregnant women who has not previously received Tdap is in need of a tetanus booster (for wound management or if it’s been more than 10 years since the previous Td), health care providers should administer Tdap during the third or late second trimester (after 20 weeks’ gestation). However, the language may be revised to allow for earlier vaccination for urgent wound management in women prior to 20 weeks’ gestation.

In addition, the ACIP recommended that pregnant women whose tetanus vaccination status is unknown or uncertain should received three vaccinations containing tetanus and reduced diphtheria toxoids during pregnancy. The recommended dosing schedule is 0, 4 weeks, and 6-12 months. Tdap should replace one dose of Td, preferably during the late second or third trimester.

As part of the same vote, the ACIP also voted to recommend "cocooning" (Tdap vaccination of adolescent and adult contacts of infants younger than 12 months) despite the lack of evidence for its effectiveness.

"The working group would never not recommend cocooning, but it is an insufficient national strategy to prevent pertussis morbidity and mortality for newborn infants," noted Dr. Jennifer Liang of the CDC, who presented data on behalf of the ACIP pertussis vaccine working group. Cocooning has been recommended since 2005, but available data show poor uptake and no evidence that cocooning programs are sustainable, she said.

The ACIP voted in favor of prenatal Tdap vaccination as preferable to postpartum vaccination when possible. "Postpartum vaccination is a suboptimal national strategy to prevent infant pertussis morbidity and mortality," said Dr. Liang. "Vaccinating pregnant women during the late second or early third trimester is acceptably safe for both mother and fetus."

Moving Tdap vaccination to the third trimester of pregnancy is the most cost-effective of several options to protect pregnant women and newborns against pertussis, said Garrett R. Beeler Asay, Ph.D., also of the CDC. Using a simulated birth cohort model of approximately 4 million infants, the cost per quality-of-life-year saved was $414,442 for vaccination during pregnancy, compared to $1,174,143 for postpartum vaccination.

The ACIP also voted to include the recommendations in the Vaccines for Children program, to state that adolescents who are pregnant would receive Tdap in the same manner as adult pregnant women.

Neither Dr. Liang nor Dr. Beeler Asay had any relevant financial disclosures.

ATLANTA – The Tdap vaccine should be given to pregnant women after 20 weeks’ gestation to help prevent pertussis in the mothers and their newborns, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

The ACIP also voted that in special situations in which a pregnant women who has not previously received Tdap is in need of a tetanus booster (for wound management or if it’s been more than 10 years since the previous Td), health care providers should administer Tdap during the third or late second trimester (after 20 weeks’ gestation). However, the language may be revised to allow for earlier vaccination for urgent wound management in women prior to 20 weeks’ gestation.

In addition, the ACIP recommended that pregnant women whose tetanus vaccination status is unknown or uncertain should received three vaccinations containing tetanus and reduced diphtheria toxoids during pregnancy. The recommended dosing schedule is 0, 4 weeks, and 6-12 months. Tdap should replace one dose of Td, preferably during the late second or third trimester.

As part of the same vote, the ACIP also voted to recommend "cocooning" (Tdap vaccination of adolescent and adult contacts of infants younger than 12 months) despite the lack of evidence for its effectiveness.

"The working group would never not recommend cocooning, but it is an insufficient national strategy to prevent pertussis morbidity and mortality for newborn infants," noted Dr. Jennifer Liang of the CDC, who presented data on behalf of the ACIP pertussis vaccine working group. Cocooning has been recommended since 2005, but available data show poor uptake and no evidence that cocooning programs are sustainable, she said.

The ACIP voted in favor of prenatal Tdap vaccination as preferable to postpartum vaccination when possible. "Postpartum vaccination is a suboptimal national strategy to prevent infant pertussis morbidity and mortality," said Dr. Liang. "Vaccinating pregnant women during the late second or early third trimester is acceptably safe for both mother and fetus."

Moving Tdap vaccination to the third trimester of pregnancy is the most cost-effective of several options to protect pregnant women and newborns against pertussis, said Garrett R. Beeler Asay, Ph.D., also of the CDC. Using a simulated birth cohort model of approximately 4 million infants, the cost per quality-of-life-year saved was $414,442 for vaccination during pregnancy, compared to $1,174,143 for postpartum vaccination.

The ACIP also voted to include the recommendations in the Vaccines for Children program, to state that adolescents who are pregnant would receive Tdap in the same manner as adult pregnant women.

Neither Dr. Liang nor Dr. Beeler Asay had any relevant financial disclosures.

ATLANTA – The meningococcal vaccine MCV4-D (Menactra) is now recommended for use in certain subgroups of high-risk children aged 9-23 months, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

Dr. Amanda Cohn of the CDC’s meningitis and vaccine preventable disease branch noted that the recommendations involve a very small subset of the population, and that they do not apply to this age group in general.

ACIP voted that specific groups of children aged 9-23 months at increased risk for meningococcal disease receive a two-dose series of MCV4-D taken 3 months apart:

• Infants needing protection prior to traveling or moving to an area where meningococcal disease is epidemic or highly endemic. Travelers can receive their two doses 2 months apart to accommodate travel schedules.

• Infants with complement component deficiencies such as C3, C5-9, properdin, factor H, and factor D deficiencies.

• Infants in a defined risk group for a community or institutional outbreak.

• Infants with HIV, if another indication for vaccination exists.

The committee, however, opted to postpone voting on whether infants aged 9-23 months with functional or anatomic asplenia, including those with sickle cell anemia, should receive the MCV4-D vaccine.

"This will be on the agenda to consider at a future time when more information becomes available," said Dr. Carol Baker, ACIP chair and professor of pediatrics at Baylor College of Medicine, Houston. "We are not just a rubber stamp for the FDA licensing."

ACIP also voted unanimously to include the recommendations in the Vaccines for Children Program.

The indication for MCV4-D as a two-dose primary series for infants aged 9-23 months was approved by the U.S. Food and Drug Administration in March 2011, Dr. Cohn said.

"This is the first meningococcal vaccine licensed in children under 24 months, but others are likely to be available within the year," she said. Prelicensure safety data met noninferiority criteria, with no serious adverse events, and postlicensure safety surveillance will be conducted for children through age 23 months, Dr. Cohn added.

The recommendations were based on immunogenicity and safety data presented by Dr. David R. Johnson of Sanofi Pasteur, manufacturer of Menactra. He presented several phase-III studies that included immunogenicity data from 1,561 infants and safety data from 3,267 infants.

In one study of 147 children, the protective response rates after two doses of MCV4-D (defined as the percent achieving serum bactericidal assay with human complement [SBA-HC] immune titers of at least a ratio of 1:8) against meningococcal serogroups A, C, Y, and W-135 were 91%, 100%, 95%, and 82%, respectively, Dr. Johnson said.

In the same study, seroprotection rates when MCV4-D was given with MMRV (measles, mumps, rubella, varicella) were higher than when PCV7 was given with MMRV. However, pneumococcal geometric mean concentrations when PVC7 was given with MCV4-D were lower than with PCV7 given with MMRV.

The impact of MCV4-D on the effectiveness of the pneumococcal vaccine was cause for concern.

"We don’t want to do anything to impact the burden of pneumococcal disease in the high-risk patients" Dr. Michael Brady, chair of the American Academy of Pediatrics committee on infectious disease, said during the discussion period prior to voting. He also is chair of the department of pediatrics at Ohio State University in Columbus.

Many ACIP members expressed similar concerns about the risks of interference that could occur with the coadministration of a pneumococcal vaccine and meningococcal vaccine in the specific subset of children with functional or anatomic asplenia, including sickle cell anemia, and the vote was postponed based on these concerns.

The rate of medically significant adverse events from 30 days to 6 months after MCV4-D plus concomitant vaccines was less than 5%. No data were presented on safety or immunogenicity data for MCV4-D and PCV13.

Current immunization schedules are available at the CDC website.

As an employee of the CDC, Dr. Cohn had no relevant financial disclosures.

ATLANTA – The meningococcal vaccine MCV4-D (Menactra) is now recommended for use in certain subgroups of high-risk children aged 9-23 months, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

Dr. Amanda Cohn of the CDC’s meningitis and vaccine preventable disease branch noted that the recommendations involve a very small subset of the population, and that they do not apply to this age group in general.

ACIP voted that specific groups of children aged 9-23 months at increased risk for meningococcal disease receive a two-dose series of MCV4-D taken 3 months apart:

• Infants needing protection prior to traveling or moving to an area where meningococcal disease is epidemic or highly endemic. Travelers can receive their two doses 2 months apart to accommodate travel schedules.

• Infants with complement component deficiencies such as C3, C5-9, properdin, factor H, and factor D deficiencies.

• Infants in a defined risk group for a community or institutional outbreak.

• Infants with HIV, if another indication for vaccination exists.

The committee, however, opted to postpone voting on whether infants aged 9-23 months with functional or anatomic asplenia, including those with sickle cell anemia, should receive the MCV4-D vaccine.

"This will be on the agenda to consider at a future time when more information becomes available," said Dr. Carol Baker, ACIP chair and professor of pediatrics at Baylor College of Medicine, Houston. "We are not just a rubber stamp for the FDA licensing."

ACIP also voted unanimously to include the recommendations in the Vaccines for Children Program.

The indication for MCV4-D as a two-dose primary series for infants aged 9-23 months was approved by the U.S. Food and Drug Administration in March 2011, Dr. Cohn said.

"This is the first meningococcal vaccine licensed in children under 24 months, but others are likely to be available within the year," she said. Prelicensure safety data met noninferiority criteria, with no serious adverse events, and postlicensure safety surveillance will be conducted for children through age 23 months, Dr. Cohn added.

The recommendations were based on immunogenicity and safety data presented by Dr. David R. Johnson of Sanofi Pasteur, manufacturer of Menactra. He presented several phase-III studies that included immunogenicity data from 1,561 infants and safety data from 3,267 infants.

In one study of 147 children, the protective response rates after two doses of MCV4-D (defined as the percent achieving serum bactericidal assay with human complement [SBA-HC] immune titers of at least a ratio of 1:8) against meningococcal serogroups A, C, Y, and W-135 were 91%, 100%, 95%, and 82%, respectively, Dr. Johnson said.

In the same study, seroprotection rates when MCV4-D was given with MMRV (measles, mumps, rubella, varicella) were higher than when PCV7 was given with MMRV. However, pneumococcal geometric mean concentrations when PVC7 was given with MCV4-D were lower than with PCV7 given with MMRV.

The impact of MCV4-D on the effectiveness of the pneumococcal vaccine was cause for concern.

"We don’t want to do anything to impact the burden of pneumococcal disease in the high-risk patients" Dr. Michael Brady, chair of the American Academy of Pediatrics committee on infectious disease, said during the discussion period prior to voting. He also is chair of the department of pediatrics at Ohio State University in Columbus.

Many ACIP members expressed similar concerns about the risks of interference that could occur with the coadministration of a pneumococcal vaccine and meningococcal vaccine in the specific subset of children with functional or anatomic asplenia, including sickle cell anemia, and the vote was postponed based on these concerns.

The rate of medically significant adverse events from 30 days to 6 months after MCV4-D plus concomitant vaccines was less than 5%. No data were presented on safety or immunogenicity data for MCV4-D and PCV13.

Current immunization schedules are available at the CDC website.

As an employee of the CDC, Dr. Cohn had no relevant financial disclosures.

ATLANTA – The meningococcal vaccine MCV4-D (Menactra) is now recommended for use in certain subgroups of high-risk children aged 9-23 months, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

Dr. Amanda Cohn of the CDC’s meningitis and vaccine preventable disease branch noted that the recommendations involve a very small subset of the population, and that they do not apply to this age group in general.

ACIP voted that specific groups of children aged 9-23 months at increased risk for meningococcal disease receive a two-dose series of MCV4-D taken 3 months apart:

• Infants needing protection prior to traveling or moving to an area where meningococcal disease is epidemic or highly endemic. Travelers can receive their two doses 2 months apart to accommodate travel schedules.

• Infants with complement component deficiencies such as C3, C5-9, properdin, factor H, and factor D deficiencies.

• Infants in a defined risk group for a community or institutional outbreak.

• Infants with HIV, if another indication for vaccination exists.

The committee, however, opted to postpone voting on whether infants aged 9-23 months with functional or anatomic asplenia, including those with sickle cell anemia, should receive the MCV4-D vaccine.

"This will be on the agenda to consider at a future time when more information becomes available," said Dr. Carol Baker, ACIP chair and professor of pediatrics at Baylor College of Medicine, Houston. "We are not just a rubber stamp for the FDA licensing."

ACIP also voted unanimously to include the recommendations in the Vaccines for Children Program.

The indication for MCV4-D as a two-dose primary series for infants aged 9-23 months was approved by the U.S. Food and Drug Administration in March 2011, Dr. Cohn said.

"This is the first meningococcal vaccine licensed in children under 24 months, but others are likely to be available within the year," she said. Prelicensure safety data met noninferiority criteria, with no serious adverse events, and postlicensure safety surveillance will be conducted for children through age 23 months, Dr. Cohn added.

The recommendations were based on immunogenicity and safety data presented by Dr. David R. Johnson of Sanofi Pasteur, manufacturer of Menactra. He presented several phase-III studies that included immunogenicity data from 1,561 infants and safety data from 3,267 infants.

In one study of 147 children, the protective response rates after two doses of MCV4-D (defined as the percent achieving serum bactericidal assay with human complement [SBA-HC] immune titers of at least a ratio of 1:8) against meningococcal serogroups A, C, Y, and W-135 were 91%, 100%, 95%, and 82%, respectively, Dr. Johnson said.

In the same study, seroprotection rates when MCV4-D was given with MMRV (measles, mumps, rubella, varicella) were higher than when PCV7 was given with MMRV. However, pneumococcal geometric mean concentrations when PVC7 was given with MCV4-D were lower than with PCV7 given with MMRV.

The impact of MCV4-D on the effectiveness of the pneumococcal vaccine was cause for concern.

"We don’t want to do anything to impact the burden of pneumococcal disease in the high-risk patients" Dr. Michael Brady, chair of the American Academy of Pediatrics committee on infectious disease, said during the discussion period prior to voting. He also is chair of the department of pediatrics at Ohio State University in Columbus.

Many ACIP members expressed similar concerns about the risks of interference that could occur with the coadministration of a pneumococcal vaccine and meningococcal vaccine in the specific subset of children with functional or anatomic asplenia, including sickle cell anemia, and the vote was postponed based on these concerns.

The rate of medically significant adverse events from 30 days to 6 months after MCV4-D plus concomitant vaccines was less than 5%. No data were presented on safety or immunogenicity data for MCV4-D and PCV13.

Current immunization schedules are available at the CDC website.

As an employee of the CDC, Dr. Cohn had no relevant financial disclosures.

ATLANTA – The meningococcal vaccine MCV4-D (Menactra) is now recommended for use in certain subgroups of high-risk children aged 9-23 months, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

Dr. Amanda Cohn of the CDC’s meningitis and vaccine preventable disease branch noted that the recommendations involve a very small subset of the population, and that they do not apply to this age group in general.

ACIP voted that specific groups of children aged 9-23 months at increased risk for meningococcal disease receive a two-dose series of MCV4-D taken 3 months apart:

• Infants needing protection prior to traveling or moving to an area where meningococcal disease is epidemic or highly endemic. Travelers can receive their two doses 2 months apart to accommodate travel schedules.

• Infants with complement component deficiencies such as C3, C5-9, properdin, factor H, and factor D deficiencies.

• Infants in a defined risk group for a community or institutional outbreak.

• Infants with HIV, if another indication for vaccination exists.

The committee, however, opted to postpone voting on whether infants aged 9-23 months with functional or anatomic asplenia, including those with sickle cell anemia, should receive the MCV4-D vaccine.

"This will be on the agenda to consider at a future time when more information becomes available," said Dr. Carol Baker, ACIP chair and professor of pediatrics at Baylor College of Medicine, Houston. "We are not just a rubber stamp for the FDA licensing."

ACIP also voted unanimously to include the recommendations in the Vaccines for Children Program.

The indication for MCV4-D as a two-dose primary series for infants aged 9-23 months was approved by the U.S. Food and Drug Administration in March 2011, Dr. Cohn said.

"This is the first meningococcal vaccine licensed in children under 24 months, but others are likely to be available within the year," she said. Prelicensure safety data met noninferiority criteria, with no serious adverse events, and postlicensure safety surveillance will be conducted for children through age 23 months, Dr. Cohn added.

The recommendations were based on immunogenicity and safety data presented by Dr. David R. Johnson of Sanofi Pasteur, manufacturer of Menactra. He presented several phase-III studies that included immunogenicity data from 1,561 infants and safety data from 3,267 infants.

In one study of 147 children, the protective response rates after two doses of MCV4-D (defined as the percent achieving serum bactericidal assay with human complement [SBA-HC] immune titers of at least a ratio of 1:8) against meningococcal serogroups A, C, Y, and W-135 were 91%, 100%, 95%, and 82%, respectively, Dr. Johnson said.

In the same study, seroprotection rates when MCV4-D was given with MMRV (measles, mumps, rubella, varicella) were higher than when PCV7 was given with MMRV. However, pneumococcal geometric mean concentrations when PVC7 was given with MCV4-D were lower than with PCV7 given with MMRV.

The impact of MCV4-D on the effectiveness of the pneumococcal vaccine was cause for concern.

"We don’t want to do anything to impact the burden of pneumococcal disease in the high-risk patients" Dr. Michael Brady, chair of the American Academy of Pediatrics committee on infectious disease, said during the discussion period prior to voting. He also is chair of the department of pediatrics at Ohio State University in Columbus.

Many ACIP members expressed similar concerns about the risks of interference that could occur with the coadministration of a pneumococcal vaccine and meningococcal vaccine in the specific subset of children with functional or anatomic asplenia, including sickle cell anemia, and the vote was postponed based on these concerns.

The rate of medically significant adverse events from 30 days to 6 months after MCV4-D plus concomitant vaccines was less than 5%. No data were presented on safety or immunogenicity data for MCV4-D and PCV13.

Current immunization schedules are available at the CDC website.

As an employee of the CDC, Dr. Cohn had no relevant financial disclosures.

ATLANTA – The meningococcal vaccine MCV4-D (Menactra) is now recommended for use in certain subgroups of high-risk children aged 9-23 months, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

Dr. Amanda Cohn of the CDC’s meningitis and vaccine preventable disease branch noted that the recommendations involve a very small subset of the population, and that they do not apply to this age group in general.

ACIP voted that specific groups of children aged 9-23 months at increased risk for meningococcal disease receive a two-dose series of MCV4-D taken 3 months apart:

• Infants needing protection prior to traveling or moving to an area where meningococcal disease is epidemic or highly endemic. Travelers can receive their two doses 2 months apart to accommodate travel schedules.

• Infants with complement component deficiencies such as C3, C5-9, properdin, factor H, and factor D deficiencies.

• Infants in a defined risk group for a community or institutional outbreak.

• Infants with HIV, if another indication for vaccination exists.

The committee, however, opted to postpone voting on whether infants aged 9-23 months with functional or anatomic asplenia, including those with sickle cell anemia, should receive the MCV4-D vaccine.

"This will be on the agenda to consider at a future time when more information becomes available," said Dr. Carol Baker, ACIP chair and professor of pediatrics at Baylor College of Medicine, Houston. "We are not just a rubber stamp for the FDA licensing."

ACIP also voted unanimously to include the recommendations in the Vaccines for Children Program.

The indication for MCV4-D as a two-dose primary series for infants aged 9-23 months was approved by the U.S. Food and Drug Administration in March 2011, Dr. Cohn said.

"This is the first meningococcal vaccine licensed in children under 24 months, but others are likely to be available within the year," she said. Prelicensure safety data met noninferiority criteria, with no serious adverse events, and postlicensure safety surveillance will be conducted for children through age 23 months, Dr. Cohn added.

The recommendations were based on immunogenicity and safety data presented by Dr. David R. Johnson of Sanofi Pasteur, manufacturer of Menactra. He presented several phase-III studies that included immunogenicity data from 1,561 infants and safety data from 3,267 infants.

In one study of 147 children, the protective response rates after two doses of MCV4-D (defined as the percent achieving serum bactericidal assay with human complement [SBA-HC] immune titers of at least a ratio of 1:8) against meningococcal serogroups A, C, Y, and W-135 were 91%, 100%, 95%, and 82%, respectively, Dr. Johnson said.

In the same study, seroprotection rates when MCV4-D was given with MMRV (measles, mumps, rubella, varicella) were higher than when PCV7 was given with MMRV. However, pneumococcal geometric mean concentrations when PVC7 was given with MCV4-D were lower than with PCV7 given with MMRV.

The impact of MCV4-D on the effectiveness of the pneumococcal vaccine was cause for concern.

"We don’t want to do anything to impact the burden of pneumococcal disease in the high-risk patients" Dr. Michael Brady, chair of the American Academy of Pediatrics committee on infectious disease, said during the discussion period prior to voting. He also is chair of the department of pediatrics at Ohio State University in Columbus.

Many ACIP members expressed similar concerns about the risks of interference that could occur with the coadministration of a pneumococcal vaccine and meningococcal vaccine in the specific subset of children with functional or anatomic asplenia, including sickle cell anemia, and the vote was postponed based on these concerns.

The rate of medically significant adverse events from 30 days to 6 months after MCV4-D plus concomitant vaccines was less than 5%. No data were presented on safety or immunogenicity data for MCV4-D and PCV13.

Current immunization schedules are available at the CDC website.

As an employee of the CDC, Dr. Cohn had no relevant financial disclosures.

ATLANTA – The meningococcal vaccine MCV4-D (Menactra) is now recommended for use in certain subgroups of high-risk children aged 9-23 months, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

Dr. Amanda Cohn of the CDC’s meningitis and vaccine preventable disease branch noted that the recommendations involve a very small subset of the population, and that they do not apply to this age group in general.

ACIP voted that specific groups of children aged 9-23 months at increased risk for meningococcal disease receive a two-dose series of MCV4-D taken 3 months apart:

• Infants needing protection prior to traveling or moving to an area where meningococcal disease is epidemic or highly endemic. Travelers can receive their two doses 2 months apart to accommodate travel schedules.

• Infants with complement component deficiencies such as C3, C5-9, properdin, factor H, and factor D deficiencies.

• Infants in a defined risk group for a community or institutional outbreak.

• Infants with HIV, if another indication for vaccination exists.

The committee, however, opted to postpone voting on whether infants aged 9-23 months with functional or anatomic asplenia, including those with sickle cell anemia, should receive the MCV4-D vaccine.

"This will be on the agenda to consider at a future time when more information becomes available," said Dr. Carol Baker, ACIP chair and professor of pediatrics at Baylor College of Medicine, Houston. "We are not just a rubber stamp for the FDA licensing."

ACIP also voted unanimously to include the recommendations in the Vaccines for Children Program.

The indication for MCV4-D as a two-dose primary series for infants aged 9-23 months was approved by the U.S. Food and Drug Administration in March 2011, Dr. Cohn said.

"This is the first meningococcal vaccine licensed in children under 24 months, but others are likely to be available within the year," she said. Prelicensure safety data met noninferiority criteria, with no serious adverse events, and postlicensure safety surveillance will be conducted for children through age 23 months, Dr. Cohn added.

The recommendations were based on immunogenicity and safety data presented by Dr. David R. Johnson of Sanofi Pasteur, manufacturer of Menactra. He presented several phase-III studies that included immunogenicity data from 1,561 infants and safety data from 3,267 infants.

In one study of 147 children, the protective response rates after two doses of MCV4-D (defined as the percent achieving serum bactericidal assay with human complement [SBA-HC] immune titers of at least a ratio of 1:8) against meningococcal serogroups A, C, Y, and W-135 were 91%, 100%, 95%, and 82%, respectively, Dr. Johnson said.

In the same study, seroprotection rates when MCV4-D was given with MMRV (measles, mumps, rubella, varicella) were higher than when PCV7 was given with MMRV. However, pneumococcal geometric mean concentrations when PVC7 was given with MCV4-D were lower than with PCV7 given with MMRV.

The impact of MCV4-D on the effectiveness of the pneumococcal vaccine was cause for concern.

"We don’t want to do anything to impact the burden of pneumococcal disease in the high-risk patients" Dr. Michael Brady, chair of the American Academy of Pediatrics committee on infectious disease, said during the discussion period prior to voting. He also is chair of the department of pediatrics at Ohio State University in Columbus.

Many ACIP members expressed similar concerns about the risks of interference that could occur with the coadministration of a pneumococcal vaccine and meningococcal vaccine in the specific subset of children with functional or anatomic asplenia, including sickle cell anemia, and the vote was postponed based on these concerns.

The rate of medically significant adverse events from 30 days to 6 months after MCV4-D plus concomitant vaccines was less than 5%. No data were presented on safety or immunogenicity data for MCV4-D and PCV13.

Current immunization schedules are available at the CDC website.

As an employee of the CDC, Dr. Cohn had no relevant financial disclosures.

Approximately one-third of health care providers conduct unnecessary low-risk testing, based on results of a survey of 376 office-based health care providers and 216 outpatient clinics published in the July 2011 issue of Obstetrics & Gynecology.

A high-risk human papillomavirus (HPV) DNA test, which detects cancer-causing HPV types, is generally used for screening and managing women with abnormal Pap test results, but there are no clinical recommendations for use of a low-risk HPV DNA test that detects five nononcogenic HPV types, said Jennifer Wai-Yin Lee, R.N., and her colleagues at the Centers for Disease Control and Prevention (Obstet. Gynecol. 2011;118:4-13).

To assess the use of different types of HPV testing, the researchers reviewed data from the 2006 Cervical Cancer Screening Supplement, a survey conducted by the CDC. Overall, 76% of the office-based providers and 77% of the outpatient clinics reported ever ordering an HPV test, and 35% of health care providers and 32% of clinics said they used low-risk HPV testing.

The finding on the use of low-risk HPV testing "is surprising," the researchers wrote. "The low-risk HPV DNA test screens for infection with nononcogenic HPV types and thus serves no purpose in the context of cervical cancer screening," they noted.

The use of low-risk HPV testing in the Unites States may be driven by a combination of factors including financial gain, test marketing, and health care provider confusion on the difference between the low-risk and high-risk tests, the researchers said.

"We discovered that the low-risk HPV test – which has no clinical indications and is not recommended by any guidelines – was actually part of an older version of the HPV test, which tested for both low- and high-risk HPV types," lead author Dr. Mona Saraiya, also of the CDC, said in an interview. "Despite newer HPV tests that screen only for high-risk types, the combined test remains in active use. Over one-third of providers in our study who used HPV testing reported using the low-risk HPV test, which is a large number and sheds light on a practice that we didn’t know much about before," she said.

Overall, office-based providers and clinics were more likely to use HPV testing to manage an abnormal Pap test (reflex or recall testing) than to augment routine cervical cancer screening (cotesting). Of the office-based providers who ordered any HPV test, 89% said they used it for managing an abnormal test result, while 47% said that they used it with the Pap test for routine cervical cancer screening. Clinics also were more likely to perform reflex or recall testing than HPV cotesting.

However, approximately 60% of the respondents (60% of office-based providers and 66% of clinics) also said they used HPV cotesting with a Pap test for routine cervical cancer screening in women younger than 30 years, although such testing is recommended only for women aged 30 years and older. And more than half of health care providers (56% of office-based providers and 55% of clinics) reported doing reflex HPV testing in women younger than 30 years.

"The concern over testing in this age group arises from the follow-up colposcopies and excisional treatments, which carry their own risks and side effects that may occur as a result of HPV testing that should not have been performed to begin with," Dr. Saraiya said.

"Clinicians may need to explain to a patient under 30 years old who is requesting the HPV test with her Pap smear why HPV testing is at best, not useful in her situation, and potentially harmful at worst," she said.

The frequent use of HPV tests in younger women in both health care settings is cause for concern, because most HPV infections in women younger than 30 years are transient, and these infections will resolve without further intervention and health care costs, the researchers noted. "Avoiding unnecessary work-up or treatment of transient HPV infections in younger women is an important goal ... because studies have found associations between certain procedures used to treat cervical dysplasia and adverse birth outcomes," including preterm delivery and perinatal mortality, the investigators noted.

In addition, 71% of office-based providers and 63% of clinics performed reflex HPV testing after Pap test results of ASC-H(atypical squamous cells, cannot rule out high-grade squamous intraepithelial lesions), although HPV testing is not recommended in these instances.

Guidelines from the American Cancer Society, the American College of Obstetricians and Gynecologists, and the American Society for Colposcopy and Cervical Pathology state that HPV DNA testing is not recommended for certain situations, including low-risk HPV types, routine cervical cancer screening in women younger than 30 years, routine screening more often than 3 years in women older than 30 years, routine sexually transmitted disease screenings, sexual assault work-ups, and initial triage of women with Pap test results of high-grade squamous epithelial lesions (HSILs) or of ASC-H, the researchers said.

The unnecessary and improper use of HPV testing suggests that actions such as limiting test reimbursement and educating health care providers are needed to eliminate unnecessary low-risk testing, the researchers said.

"When it comes to low-risk HPV testing, the take-home message to clinicians is simple: Women should stop being tested for low-risk HPV," Ms. Lee said in an interview. "We already know that low-risk HPV types are nononcogenic, so testing for low-risk HPV is not useful in determining a woman’s risk for developing cervical cancer. We also want to make clear that although low-risk HPV types are associated with genital warts, having a positive low-risk HPV test does not mean a woman will develop genital warts, nor does it provide any prognosis for women who have genital warts," she said.

"By knowing this information, clinicians will hopefully feel empowered to request their laboratories to provide high-risk-HPV-only testing, instead of a combined low- and high-risk HPV test," she added.

More work is needed to improve the clinical value of HPV testing, the researchers said. "Eliminating the low-risk HPV test and making the high-risk HPV test the only option would help minimize confusion for providers when ordering the HPV test. Removing incentives for this practice like insurance reimbursement is another method that may be effective," Ms. Lee said.

"Interventions that can help providers use HPV tests appropriately include changing laboratory requisition forms to reflect guideline-consistent HPV testing and point-of-care decision support algorithms that are designed to give patient-specific recommendations," she said.

In an accompanying editorial, Philip E. Castle, Ph.D., of the American Society for Clinical Pathology in Chicago, noted that the overuse and improper use of HPV testing has negative effects on patients: "A patient who tests HPV positive has a wide range of negative psychosocial and psychosexual outcomes, including anxiety, distress, and a decreased sense of sexual well-being."

He also emphasized the impact of unnecessary HPV testing on the health care system: "With an estimated $4 billion spent on cervical cancer prevention alone in 2004, we can no longer afford to perform tests that do not benefit our patients" (Obstet. Gynecol. 2011;118:1-3).

Dr. Castle supported the study authors’ call for better education of clinicians, for they have the final responsibility for the use of HPV testing. He said it also would be helpful if payers stopped reimbursing for these unnecessary HPV tests, for that would quickly put a halt to such practices. He emphasized, "Overuse of HPV testing not only seriously wastes government, payer, and patient dollars, but also potentially harms patients, therefore violating the first tenet of the Hippocratic Oath: Do no harm."

Neither the study authors nor Dr. Castle said they had any relevant financial disclosures.

Approximately one-third of health care providers conduct unnecessary low-risk testing, based on results of a survey of 376 office-based health care providers and 216 outpatient clinics published in the July 2011 issue of Obstetrics & Gynecology.

A high-risk human papillomavirus (HPV) DNA test, which detects cancer-causing HPV types, is generally used for screening and managing women with abnormal Pap test results, but there are no clinical recommendations for use of a low-risk HPV DNA test that detects five nononcogenic HPV types, said Jennifer Wai-Yin Lee, R.N., and her colleagues at the Centers for Disease Control and Prevention (Obstet. Gynecol. 2011;118:4-13).

To assess the use of different types of HPV testing, the researchers reviewed data from the 2006 Cervical Cancer Screening Supplement, a survey conducted by the CDC. Overall, 76% of the office-based providers and 77% of the outpatient clinics reported ever ordering an HPV test, and 35% of health care providers and 32% of clinics said they used low-risk HPV testing.

The finding on the use of low-risk HPV testing "is surprising," the researchers wrote. "The low-risk HPV DNA test screens for infection with nononcogenic HPV types and thus serves no purpose in the context of cervical cancer screening," they noted.

The use of low-risk HPV testing in the Unites States may be driven by a combination of factors including financial gain, test marketing, and health care provider confusion on the difference between the low-risk and high-risk tests, the researchers said.

"We discovered that the low-risk HPV test – which has no clinical indications and is not recommended by any guidelines – was actually part of an older version of the HPV test, which tested for both low- and high-risk HPV types," lead author Dr. Mona Saraiya, also of the CDC, said in an interview. "Despite newer HPV tests that screen only for high-risk types, the combined test remains in active use. Over one-third of providers in our study who used HPV testing reported using the low-risk HPV test, which is a large number and sheds light on a practice that we didn’t know much about before," she said.

Overall, office-based providers and clinics were more likely to use HPV testing to manage an abnormal Pap test (reflex or recall testing) than to augment routine cervical cancer screening (cotesting). Of the office-based providers who ordered any HPV test, 89% said they used it for managing an abnormal test result, while 47% said that they used it with the Pap test for routine cervical cancer screening. Clinics also were more likely to perform reflex or recall testing than HPV cotesting.

However, approximately 60% of the respondents (60% of office-based providers and 66% of clinics) also said they used HPV cotesting with a Pap test for routine cervical cancer screening in women younger than 30 years, although such testing is recommended only for women aged 30 years and older. And more than half of health care providers (56% of office-based providers and 55% of clinics) reported doing reflex HPV testing in women younger than 30 years.

"The concern over testing in this age group arises from the follow-up colposcopies and excisional treatments, which carry their own risks and side effects that may occur as a result of HPV testing that should not have been performed to begin with," Dr. Saraiya said.

"Clinicians may need to explain to a patient under 30 years old who is requesting the HPV test with her Pap smear why HPV testing is at best, not useful in her situation, and potentially harmful at worst," she said.

The frequent use of HPV tests in younger women in both health care settings is cause for concern, because most HPV infections in women younger than 30 years are transient, and these infections will resolve without further intervention and health care costs, the researchers noted. "Avoiding unnecessary work-up or treatment of transient HPV infections in younger women is an important goal ... because studies have found associations between certain procedures used to treat cervical dysplasia and adverse birth outcomes," including preterm delivery and perinatal mortality, the investigators noted.

In addition, 71% of office-based providers and 63% of clinics performed reflex HPV testing after Pap test results of ASC-H(atypical squamous cells, cannot rule out high-grade squamous intraepithelial lesions), although HPV testing is not recommended in these instances.

Guidelines from the American Cancer Society, the American College of Obstetricians and Gynecologists, and the American Society for Colposcopy and Cervical Pathology state that HPV DNA testing is not recommended for certain situations, including low-risk HPV types, routine cervical cancer screening in women younger than 30 years, routine screening more often than 3 years in women older than 30 years, routine sexually transmitted disease screenings, sexual assault work-ups, and initial triage of women with Pap test results of high-grade squamous epithelial lesions (HSILs) or of ASC-H, the researchers said.

The unnecessary and improper use of HPV testing suggests that actions such as limiting test reimbursement and educating health care providers are needed to eliminate unnecessary low-risk testing, the researchers said.

"When it comes to low-risk HPV testing, the take-home message to clinicians is simple: Women should stop being tested for low-risk HPV," Ms. Lee said in an interview. "We already know that low-risk HPV types are nononcogenic, so testing for low-risk HPV is not useful in determining a woman’s risk for developing cervical cancer. We also want to make clear that although low-risk HPV types are associated with genital warts, having a positive low-risk HPV test does not mean a woman will develop genital warts, nor does it provide any prognosis for women who have genital warts," she said.

"By knowing this information, clinicians will hopefully feel empowered to request their laboratories to provide high-risk-HPV-only testing, instead of a combined low- and high-risk HPV test," she added.

More work is needed to improve the clinical value of HPV testing, the researchers said. "Eliminating the low-risk HPV test and making the high-risk HPV test the only option would help minimize confusion for providers when ordering the HPV test. Removing incentives for this practice like insurance reimbursement is another method that may be effective," Ms. Lee said.

"Interventions that can help providers use HPV tests appropriately include changing laboratory requisition forms to reflect guideline-consistent HPV testing and point-of-care decision support algorithms that are designed to give patient-specific recommendations," she said.

In an accompanying editorial, Philip E. Castle, Ph.D., of the American Society for Clinical Pathology in Chicago, noted that the overuse and improper use of HPV testing has negative effects on patients: "A patient who tests HPV positive has a wide range of negative psychosocial and psychosexual outcomes, including anxiety, distress, and a decreased sense of sexual well-being."

He also emphasized the impact of unnecessary HPV testing on the health care system: "With an estimated $4 billion spent on cervical cancer prevention alone in 2004, we can no longer afford to perform tests that do not benefit our patients" (Obstet. Gynecol. 2011;118:1-3).

Dr. Castle supported the study authors’ call for better education of clinicians, for they have the final responsibility for the use of HPV testing. He said it also would be helpful if payers stopped reimbursing for these unnecessary HPV tests, for that would quickly put a halt to such practices. He emphasized, "Overuse of HPV testing not only seriously wastes government, payer, and patient dollars, but also potentially harms patients, therefore violating the first tenet of the Hippocratic Oath: Do no harm."

Neither the study authors nor Dr. Castle said they had any relevant financial disclosures.

Approximately one-third of health care providers conduct unnecessary low-risk testing, based on results of a survey of 376 office-based health care providers and 216 outpatient clinics published in the July 2011 issue of Obstetrics & Gynecology.

A high-risk human papillomavirus (HPV) DNA test, which detects cancer-causing HPV types, is generally used for screening and managing women with abnormal Pap test results, but there are no clinical recommendations for use of a low-risk HPV DNA test that detects five nononcogenic HPV types, said Jennifer Wai-Yin Lee, R.N., and her colleagues at the Centers for Disease Control and Prevention (Obstet. Gynecol. 2011;118:4-13).

To assess the use of different types of HPV testing, the researchers reviewed data from the 2006 Cervical Cancer Screening Supplement, a survey conducted by the CDC. Overall, 76% of the office-based providers and 77% of the outpatient clinics reported ever ordering an HPV test, and 35% of health care providers and 32% of clinics said they used low-risk HPV testing.

The finding on the use of low-risk HPV testing "is surprising," the researchers wrote. "The low-risk HPV DNA test screens for infection with nononcogenic HPV types and thus serves no purpose in the context of cervical cancer screening," they noted.

The use of low-risk HPV testing in the Unites States may be driven by a combination of factors including financial gain, test marketing, and health care provider confusion on the difference between the low-risk and high-risk tests, the researchers said.

"We discovered that the low-risk HPV test – which has no clinical indications and is not recommended by any guidelines – was actually part of an older version of the HPV test, which tested for both low- and high-risk HPV types," lead author Dr. Mona Saraiya, also of the CDC, said in an interview. "Despite newer HPV tests that screen only for high-risk types, the combined test remains in active use. Over one-third of providers in our study who used HPV testing reported using the low-risk HPV test, which is a large number and sheds light on a practice that we didn’t know much about before," she said.

Overall, office-based providers and clinics were more likely to use HPV testing to manage an abnormal Pap test (reflex or recall testing) than to augment routine cervical cancer screening (cotesting). Of the office-based providers who ordered any HPV test, 89% said they used it for managing an abnormal test result, while 47% said that they used it with the Pap test for routine cervical cancer screening. Clinics also were more likely to perform reflex or recall testing than HPV cotesting.

However, approximately 60% of the respondents (60% of office-based providers and 66% of clinics) also said they used HPV cotesting with a Pap test for routine cervical cancer screening in women younger than 30 years, although such testing is recommended only for women aged 30 years and older. And more than half of health care providers (56% of office-based providers and 55% of clinics) reported doing reflex HPV testing in women younger than 30 years.

"The concern over testing in this age group arises from the follow-up colposcopies and excisional treatments, which carry their own risks and side effects that may occur as a result of HPV testing that should not have been performed to begin with," Dr. Saraiya said.

"Clinicians may need to explain to a patient under 30 years old who is requesting the HPV test with her Pap smear why HPV testing is at best, not useful in her situation, and potentially harmful at worst," she said.

The frequent use of HPV tests in younger women in both health care settings is cause for concern, because most HPV infections in women younger than 30 years are transient, and these infections will resolve without further intervention and health care costs, the researchers noted. "Avoiding unnecessary work-up or treatment of transient HPV infections in younger women is an important goal ... because studies have found associations between certain procedures used to treat cervical dysplasia and adverse birth outcomes," including preterm delivery and perinatal mortality, the investigators noted.

In addition, 71% of office-based providers and 63% of clinics performed reflex HPV testing after Pap test results of ASC-H(atypical squamous cells, cannot rule out high-grade squamous intraepithelial lesions), although HPV testing is not recommended in these instances.

Guidelines from the American Cancer Society, the American College of Obstetricians and Gynecologists, and the American Society for Colposcopy and Cervical Pathology state that HPV DNA testing is not recommended for certain situations, including low-risk HPV types, routine cervical cancer screening in women younger than 30 years, routine screening more often than 3 years in women older than 30 years, routine sexually transmitted disease screenings, sexual assault work-ups, and initial triage of women with Pap test results of high-grade squamous epithelial lesions (HSILs) or of ASC-H, the researchers said.

The unnecessary and improper use of HPV testing suggests that actions such as limiting test reimbursement and educating health care providers are needed to eliminate unnecessary low-risk testing, the researchers said.

"When it comes to low-risk HPV testing, the take-home message to clinicians is simple: Women should stop being tested for low-risk HPV," Ms. Lee said in an interview. "We already know that low-risk HPV types are nononcogenic, so testing for low-risk HPV is not useful in determining a woman’s risk for developing cervical cancer. We also want to make clear that although low-risk HPV types are associated with genital warts, having a positive low-risk HPV test does not mean a woman will develop genital warts, nor does it provide any prognosis for women who have genital warts," she said.

"By knowing this information, clinicians will hopefully feel empowered to request their laboratories to provide high-risk-HPV-only testing, instead of a combined low- and high-risk HPV test," she added.

More work is needed to improve the clinical value of HPV testing, the researchers said. "Eliminating the low-risk HPV test and making the high-risk HPV test the only option would help minimize confusion for providers when ordering the HPV test. Removing incentives for this practice like insurance reimbursement is another method that may be effective," Ms. Lee said.

"Interventions that can help providers use HPV tests appropriately include changing laboratory requisition forms to reflect guideline-consistent HPV testing and point-of-care decision support algorithms that are designed to give patient-specific recommendations," she said.

In an accompanying editorial, Philip E. Castle, Ph.D., of the American Society for Clinical Pathology in Chicago, noted that the overuse and improper use of HPV testing has negative effects on patients: "A patient who tests HPV positive has a wide range of negative psychosocial and psychosexual outcomes, including anxiety, distress, and a decreased sense of sexual well-being."

He also emphasized the impact of unnecessary HPV testing on the health care system: "With an estimated $4 billion spent on cervical cancer prevention alone in 2004, we can no longer afford to perform tests that do not benefit our patients" (Obstet. Gynecol. 2011;118:1-3).

Dr. Castle supported the study authors’ call for better education of clinicians, for they have the final responsibility for the use of HPV testing. He said it also would be helpful if payers stopped reimbursing for these unnecessary HPV tests, for that would quickly put a halt to such practices. He emphasized, "Overuse of HPV testing not only seriously wastes government, payer, and patient dollars, but also potentially harms patients, therefore violating the first tenet of the Hippocratic Oath: Do no harm."

Neither the study authors nor Dr. Castle said they had any relevant financial disclosures.