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ACIP approves flu vaccine recommendations for 2019-2020 season
All individuals aged 6 months and older should receive the influenza vaccine by the end of October next season, according to the Centers for Disease Control and Prevention’s Committee on Immunization Practices. The committee voted unanimously to accept minor updates to the ACIP flu recommendations for the 2019-2020 season, but no major changes were made from recent years.
The past flu season was moderate overall, but notable for two waves of viral infections of similar magnitude, one with H1N1 and another with H3N2, said Lynette Brewer of the CDC’s National Center for Immunization and Respiratory Diseases, who presented data on last year’s flu activity.
Last year’s vaccine likely prevented between 40,000 and 90,000 hospitalizations, but mostly reduced the burden of H1N1 disease and provided no real protection against H3N2, she said.
The recommended H3N2 component for next season is A/Kansas/14/2017–like virus, which is genetically similar to the H3N2 that circulated last year.
Lisa Grohskopf, MD, of the CDC’s influenza division, presented the minor adjustments that included the changes in vaccine composition for next year, some licensure changes, and a new table summarizing dose volumes. Also, language was changed to advise vaccination for all eligible individuals by the end of October, and individuals who need two doses should have the first one as soon as it becomes available, in July or August if possible. The updated language also clarified that 8 year olds who need two doses should receive the second dose, even if they turn 9 between the two doses.
Additional guidance updates approved by the committee included harmonizing language on groups that should be the focus of vaccination in the event of limited supply to be more consistent with the 2011 ACIP Recommendations for the Immunization of Health Care Personnel.
The committee also voted unanimously to accept the proposed influenza vaccine in the Vaccines for Children program; there were no changes in recommended dosing intervals, dosages, contraindications, or precautions, according to Frank Whitlach of the National Center for Immunization and Respiratory Diseases, who presented the Vaccines for Children information.
The ACIP members had no financial conflicts to disclose.
All individuals aged 6 months and older should receive the influenza vaccine by the end of October next season, according to the Centers for Disease Control and Prevention’s Committee on Immunization Practices. The committee voted unanimously to accept minor updates to the ACIP flu recommendations for the 2019-2020 season, but no major changes were made from recent years.
The past flu season was moderate overall, but notable for two waves of viral infections of similar magnitude, one with H1N1 and another with H3N2, said Lynette Brewer of the CDC’s National Center for Immunization and Respiratory Diseases, who presented data on last year’s flu activity.
Last year’s vaccine likely prevented between 40,000 and 90,000 hospitalizations, but mostly reduced the burden of H1N1 disease and provided no real protection against H3N2, she said.
The recommended H3N2 component for next season is A/Kansas/14/2017–like virus, which is genetically similar to the H3N2 that circulated last year.
Lisa Grohskopf, MD, of the CDC’s influenza division, presented the minor adjustments that included the changes in vaccine composition for next year, some licensure changes, and a new table summarizing dose volumes. Also, language was changed to advise vaccination for all eligible individuals by the end of October, and individuals who need two doses should have the first one as soon as it becomes available, in July or August if possible. The updated language also clarified that 8 year olds who need two doses should receive the second dose, even if they turn 9 between the two doses.
Additional guidance updates approved by the committee included harmonizing language on groups that should be the focus of vaccination in the event of limited supply to be more consistent with the 2011 ACIP Recommendations for the Immunization of Health Care Personnel.
The committee also voted unanimously to accept the proposed influenza vaccine in the Vaccines for Children program; there were no changes in recommended dosing intervals, dosages, contraindications, or precautions, according to Frank Whitlach of the National Center for Immunization and Respiratory Diseases, who presented the Vaccines for Children information.
The ACIP members had no financial conflicts to disclose.
All individuals aged 6 months and older should receive the influenza vaccine by the end of October next season, according to the Centers for Disease Control and Prevention’s Committee on Immunization Practices. The committee voted unanimously to accept minor updates to the ACIP flu recommendations for the 2019-2020 season, but no major changes were made from recent years.
The past flu season was moderate overall, but notable for two waves of viral infections of similar magnitude, one with H1N1 and another with H3N2, said Lynette Brewer of the CDC’s National Center for Immunization and Respiratory Diseases, who presented data on last year’s flu activity.
Last year’s vaccine likely prevented between 40,000 and 90,000 hospitalizations, but mostly reduced the burden of H1N1 disease and provided no real protection against H3N2, she said.
The recommended H3N2 component for next season is A/Kansas/14/2017–like virus, which is genetically similar to the H3N2 that circulated last year.
Lisa Grohskopf, MD, of the CDC’s influenza division, presented the minor adjustments that included the changes in vaccine composition for next year, some licensure changes, and a new table summarizing dose volumes. Also, language was changed to advise vaccination for all eligible individuals by the end of October, and individuals who need two doses should have the first one as soon as it becomes available, in July or August if possible. The updated language also clarified that 8 year olds who need two doses should receive the second dose, even if they turn 9 between the two doses.
Additional guidance updates approved by the committee included harmonizing language on groups that should be the focus of vaccination in the event of limited supply to be more consistent with the 2011 ACIP Recommendations for the Immunization of Health Care Personnel.
The committee also voted unanimously to accept the proposed influenza vaccine in the Vaccines for Children program; there were no changes in recommended dosing intervals, dosages, contraindications, or precautions, according to Frank Whitlach of the National Center for Immunization and Respiratory Diseases, who presented the Vaccines for Children information.
The ACIP members had no financial conflicts to disclose.
REPORTING FROM AN ACIP MEETING
ACIP endorses catch-up hepatitis A vaccinations
The Centers for Disease Control and Prevention’s Committee on Immunization Practices voted unanimously in support of three recommendations for the use of hepatitis A vaccines.
The committee recommended catch-up vaccination at any age for all children aged 2-18 years who had not previously received hepatitis A vaccination, recommended that all persons with HIV aged 1 year and older should be vaccinated with the hepatitis A vaccine, and approved updating the language in the full hepatitis A vaccine statement, “Prevention of Hepatitis A Virus Infection in The United States: Recommendations of The Advisory Committee on Immunization Practices.”
Catch-up vaccination will expand coverage to adolescents who might have missed it, and data show that the vaccine effectiveness is high, and the rates of adverse events are low in the child and adolescent population, said Noele Nelson, MD, of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, who presented the recommendations to the committee. “Recent outbreaks are occurring primarily among adults,” and many cases are among persons who use drugs or are homeless, she added.
Several committee members noted that the specific recommendations for catch-up in children and teens and for vaccination of HIV patients offer more opportunities for protection than risk-based recommendations. Catching up with vaccinating adolescents is “more effective than tracking down high-risk adults later in life,” noted Grace Lee, MD, of Lucile Packard Children’s Hospital at Stanford, Calif.
The committee also recommended that all persons with HIV aged 1 year and older should be vaccinated with the hepatitis A vaccine. Data on persons with HIV show that approximately 60% have at least one risk factor for hepatitis A, such as men who have sex with men or individuals engaged in intravenous drug use, said Dr. Nelson. Data also show that individuals with HIV are at increased risk for complications if they get hepatitis A.
The committee’s approval of the full hepatitis A vaccine statement included one notable change – the removal of clotting factor disorders as a high-risk group. The risk has decreased over time based on improvements such as better screening of source plasma, and this group is now at no greater risk than the general population, according to work group chair Kelly Moore, MD, of Vanderbilt University, Nashville, Tenn.
The ACIP members had no financial conflicts to disclose.
The Centers for Disease Control and Prevention’s Committee on Immunization Practices voted unanimously in support of three recommendations for the use of hepatitis A vaccines.
The committee recommended catch-up vaccination at any age for all children aged 2-18 years who had not previously received hepatitis A vaccination, recommended that all persons with HIV aged 1 year and older should be vaccinated with the hepatitis A vaccine, and approved updating the language in the full hepatitis A vaccine statement, “Prevention of Hepatitis A Virus Infection in The United States: Recommendations of The Advisory Committee on Immunization Practices.”
Catch-up vaccination will expand coverage to adolescents who might have missed it, and data show that the vaccine effectiveness is high, and the rates of adverse events are low in the child and adolescent population, said Noele Nelson, MD, of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, who presented the recommendations to the committee. “Recent outbreaks are occurring primarily among adults,” and many cases are among persons who use drugs or are homeless, she added.
Several committee members noted that the specific recommendations for catch-up in children and teens and for vaccination of HIV patients offer more opportunities for protection than risk-based recommendations. Catching up with vaccinating adolescents is “more effective than tracking down high-risk adults later in life,” noted Grace Lee, MD, of Lucile Packard Children’s Hospital at Stanford, Calif.
The committee also recommended that all persons with HIV aged 1 year and older should be vaccinated with the hepatitis A vaccine. Data on persons with HIV show that approximately 60% have at least one risk factor for hepatitis A, such as men who have sex with men or individuals engaged in intravenous drug use, said Dr. Nelson. Data also show that individuals with HIV are at increased risk for complications if they get hepatitis A.
The committee’s approval of the full hepatitis A vaccine statement included one notable change – the removal of clotting factor disorders as a high-risk group. The risk has decreased over time based on improvements such as better screening of source plasma, and this group is now at no greater risk than the general population, according to work group chair Kelly Moore, MD, of Vanderbilt University, Nashville, Tenn.
The ACIP members had no financial conflicts to disclose.
The Centers for Disease Control and Prevention’s Committee on Immunization Practices voted unanimously in support of three recommendations for the use of hepatitis A vaccines.
The committee recommended catch-up vaccination at any age for all children aged 2-18 years who had not previously received hepatitis A vaccination, recommended that all persons with HIV aged 1 year and older should be vaccinated with the hepatitis A vaccine, and approved updating the language in the full hepatitis A vaccine statement, “Prevention of Hepatitis A Virus Infection in The United States: Recommendations of The Advisory Committee on Immunization Practices.”
Catch-up vaccination will expand coverage to adolescents who might have missed it, and data show that the vaccine effectiveness is high, and the rates of adverse events are low in the child and adolescent population, said Noele Nelson, MD, of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, who presented the recommendations to the committee. “Recent outbreaks are occurring primarily among adults,” and many cases are among persons who use drugs or are homeless, she added.
Several committee members noted that the specific recommendations for catch-up in children and teens and for vaccination of HIV patients offer more opportunities for protection than risk-based recommendations. Catching up with vaccinating adolescents is “more effective than tracking down high-risk adults later in life,” noted Grace Lee, MD, of Lucile Packard Children’s Hospital at Stanford, Calif.
The committee also recommended that all persons with HIV aged 1 year and older should be vaccinated with the hepatitis A vaccine. Data on persons with HIV show that approximately 60% have at least one risk factor for hepatitis A, such as men who have sex with men or individuals engaged in intravenous drug use, said Dr. Nelson. Data also show that individuals with HIV are at increased risk for complications if they get hepatitis A.
The committee’s approval of the full hepatitis A vaccine statement included one notable change – the removal of clotting factor disorders as a high-risk group. The risk has decreased over time based on improvements such as better screening of source plasma, and this group is now at no greater risk than the general population, according to work group chair Kelly Moore, MD, of Vanderbilt University, Nashville, Tenn.
The ACIP members had no financial conflicts to disclose.
REPORTING FROM AN ACIP MEETING
More than half of U.S. adults have never received HIV screening
Despite a 2006 recommendation by the Centers for Disease Control and Prevention recommending universal screening for HIV, less than half of U.S. adults have ever been tested for the disease, a new study found.
“HIV screening is a critical entry point to a range of HIV prevention and treatment options. For persons at ongoing risk for HIV infection exposure, annual screening also offers the opportunity to discuss options to reduce risk, including HIV preexposure prophylaxis,” Marc A. Pitasi, MPH, and investigators from the CDC wrote in the Morbidity and Mortality Weekly Report.
The CDC investigators analyzed data collected from the Behavioral Risk Factor Surveillance System in 2016-2017 to assess the percentage of adults screened for HIV ever and in the past year across the entirety of the United States, in 50 local jurisdictions where the majority of new U.S. HIV cases occur, and in seven states with a disproportionately high rate of HIV in rural populations.
The rate of ever testing was 38.9% across the entire country, 46.9% in the 50 local jurisdictions, and 35.5% in the seven states. The percentage of adults who had undergone HIV screening in the past year was significantly smaller at 10.1% across the entire country, 14.5% in the 50 local jurisdictions, and 9.3% in the seven states. This improved to 29.2%, 34.3%, and 26.2%, respectively, in adults who were tested in the past year who were also at risk for the disease.
The rate of ever testing varied widely among the 50 jurisdictions, ranging from 36.5% in Maricopa County, Ariz., to 70.7% in Washington, D.C. However, in addition to D.C., only Baltimore, Bronx County (N.Y.), and New York County reached or exceeded 60% coverage. Bronx County also had the highest rate of HIV screening in the past year at 31.3%, while Alameda County, Calif., had the lowest rate at 8.1%.
Of the seven states (Alabama, Arkansas, Kentucky, Mississippi, Missouri, Oklahoma, and South Carolina), Mississippi had the highest overall ever-testing rate at 40.2%, and Oklahoma had the lowest at 29.7%. People living in rural areas in those states were less likely to have ever been tested (32.1%) than those living in urban areas (37.2%). The difference between rural and urban areas increased for people at risk for HIV who had been screened in the past year, with 18.4% and 29.0%, respectively, reporting undergoing screening.
“These data provide a baseline from which to measure changes in screening in these jurisdictions and other parts of the United States over time. To achieve national goals and end the HIV epidemic in the United States, innovative and novel screening approaches might be needed to reach segments of the population that have never been tested for HIV,” the investigators concluded.
The investigators reported no conflicts of interest.
SOURCE: Pitasi MA et al. MMWR Morb Mortal Wkly Rep. 2019;68:561-7.
Despite a 2006 recommendation by the Centers for Disease Control and Prevention recommending universal screening for HIV, less than half of U.S. adults have ever been tested for the disease, a new study found.
“HIV screening is a critical entry point to a range of HIV prevention and treatment options. For persons at ongoing risk for HIV infection exposure, annual screening also offers the opportunity to discuss options to reduce risk, including HIV preexposure prophylaxis,” Marc A. Pitasi, MPH, and investigators from the CDC wrote in the Morbidity and Mortality Weekly Report.
The CDC investigators analyzed data collected from the Behavioral Risk Factor Surveillance System in 2016-2017 to assess the percentage of adults screened for HIV ever and in the past year across the entirety of the United States, in 50 local jurisdictions where the majority of new U.S. HIV cases occur, and in seven states with a disproportionately high rate of HIV in rural populations.
The rate of ever testing was 38.9% across the entire country, 46.9% in the 50 local jurisdictions, and 35.5% in the seven states. The percentage of adults who had undergone HIV screening in the past year was significantly smaller at 10.1% across the entire country, 14.5% in the 50 local jurisdictions, and 9.3% in the seven states. This improved to 29.2%, 34.3%, and 26.2%, respectively, in adults who were tested in the past year who were also at risk for the disease.
The rate of ever testing varied widely among the 50 jurisdictions, ranging from 36.5% in Maricopa County, Ariz., to 70.7% in Washington, D.C. However, in addition to D.C., only Baltimore, Bronx County (N.Y.), and New York County reached or exceeded 60% coverage. Bronx County also had the highest rate of HIV screening in the past year at 31.3%, while Alameda County, Calif., had the lowest rate at 8.1%.
Of the seven states (Alabama, Arkansas, Kentucky, Mississippi, Missouri, Oklahoma, and South Carolina), Mississippi had the highest overall ever-testing rate at 40.2%, and Oklahoma had the lowest at 29.7%. People living in rural areas in those states were less likely to have ever been tested (32.1%) than those living in urban areas (37.2%). The difference between rural and urban areas increased for people at risk for HIV who had been screened in the past year, with 18.4% and 29.0%, respectively, reporting undergoing screening.
“These data provide a baseline from which to measure changes in screening in these jurisdictions and other parts of the United States over time. To achieve national goals and end the HIV epidemic in the United States, innovative and novel screening approaches might be needed to reach segments of the population that have never been tested for HIV,” the investigators concluded.
The investigators reported no conflicts of interest.
SOURCE: Pitasi MA et al. MMWR Morb Mortal Wkly Rep. 2019;68:561-7.
Despite a 2006 recommendation by the Centers for Disease Control and Prevention recommending universal screening for HIV, less than half of U.S. adults have ever been tested for the disease, a new study found.
“HIV screening is a critical entry point to a range of HIV prevention and treatment options. For persons at ongoing risk for HIV infection exposure, annual screening also offers the opportunity to discuss options to reduce risk, including HIV preexposure prophylaxis,” Marc A. Pitasi, MPH, and investigators from the CDC wrote in the Morbidity and Mortality Weekly Report.
The CDC investigators analyzed data collected from the Behavioral Risk Factor Surveillance System in 2016-2017 to assess the percentage of adults screened for HIV ever and in the past year across the entirety of the United States, in 50 local jurisdictions where the majority of new U.S. HIV cases occur, and in seven states with a disproportionately high rate of HIV in rural populations.
The rate of ever testing was 38.9% across the entire country, 46.9% in the 50 local jurisdictions, and 35.5% in the seven states. The percentage of adults who had undergone HIV screening in the past year was significantly smaller at 10.1% across the entire country, 14.5% in the 50 local jurisdictions, and 9.3% in the seven states. This improved to 29.2%, 34.3%, and 26.2%, respectively, in adults who were tested in the past year who were also at risk for the disease.
The rate of ever testing varied widely among the 50 jurisdictions, ranging from 36.5% in Maricopa County, Ariz., to 70.7% in Washington, D.C. However, in addition to D.C., only Baltimore, Bronx County (N.Y.), and New York County reached or exceeded 60% coverage. Bronx County also had the highest rate of HIV screening in the past year at 31.3%, while Alameda County, Calif., had the lowest rate at 8.1%.
Of the seven states (Alabama, Arkansas, Kentucky, Mississippi, Missouri, Oklahoma, and South Carolina), Mississippi had the highest overall ever-testing rate at 40.2%, and Oklahoma had the lowest at 29.7%. People living in rural areas in those states were less likely to have ever been tested (32.1%) than those living in urban areas (37.2%). The difference between rural and urban areas increased for people at risk for HIV who had been screened in the past year, with 18.4% and 29.0%, respectively, reporting undergoing screening.
“These data provide a baseline from which to measure changes in screening in these jurisdictions and other parts of the United States over time. To achieve national goals and end the HIV epidemic in the United States, innovative and novel screening approaches might be needed to reach segments of the population that have never been tested for HIV,” the investigators concluded.
The investigators reported no conflicts of interest.
SOURCE: Pitasi MA et al. MMWR Morb Mortal Wkly Rep. 2019;68:561-7.
FROM MMWR
ACIP adds hexavalent vaccine to VFC program
The pediatric hexavalent vaccine (DTaP-[inactivated poliovirus] IPV-[hepatitis B] HepB-[Haemophilis influenzae type b] Hib) should be included as an option in the Vaccines for Children (VFC) program for the infant series at ages 2, 4, and 6 months, according to unanimous votes at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
The addition of the vaccine to the VFC program required no motions on the part of the committee, but involved separate votes on each component of the vaccine.
Combination vaccination has been associated with increased coverage and more likely completion of the full infant vaccine series, said Sara Oliver, MD, of the CDC’s National Center for Immunization and Respiratory Diseases.
The new vaccine is being developed jointly by Sanofi and Merck, and has been approved by the Food and Drug Administration for use in children through age 4 years.
Dr. Oliver presented evidence that the safety profile of the combination vaccine is consistent with that of the component vaccines. In addition, “use of combination vaccines can reduce the number of injections patient receive and alleviate concern associated with the number of injections,” she said. However, “considerations should include provider assessment, patient preference, and the potential for adverse events.”
although it will not be available until 2021 in order to ensure sufficient supply, Dr. Oliver noted.
The combination vaccination work group considered whether the new vaccine should be preferentially recommended for American Indian and Alaskan Native populations, but they concluded that post–dose one immunogenicity data are needed before such a preferential recommendation can be made.
The ACIP members had no financial conflicts to disclose.
The pediatric hexavalent vaccine (DTaP-[inactivated poliovirus] IPV-[hepatitis B] HepB-[Haemophilis influenzae type b] Hib) should be included as an option in the Vaccines for Children (VFC) program for the infant series at ages 2, 4, and 6 months, according to unanimous votes at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
The addition of the vaccine to the VFC program required no motions on the part of the committee, but involved separate votes on each component of the vaccine.
Combination vaccination has been associated with increased coverage and more likely completion of the full infant vaccine series, said Sara Oliver, MD, of the CDC’s National Center for Immunization and Respiratory Diseases.
The new vaccine is being developed jointly by Sanofi and Merck, and has been approved by the Food and Drug Administration for use in children through age 4 years.
Dr. Oliver presented evidence that the safety profile of the combination vaccine is consistent with that of the component vaccines. In addition, “use of combination vaccines can reduce the number of injections patient receive and alleviate concern associated with the number of injections,” she said. However, “considerations should include provider assessment, patient preference, and the potential for adverse events.”
although it will not be available until 2021 in order to ensure sufficient supply, Dr. Oliver noted.
The combination vaccination work group considered whether the new vaccine should be preferentially recommended for American Indian and Alaskan Native populations, but they concluded that post–dose one immunogenicity data are needed before such a preferential recommendation can be made.
The ACIP members had no financial conflicts to disclose.
The pediatric hexavalent vaccine (DTaP-[inactivated poliovirus] IPV-[hepatitis B] HepB-[Haemophilis influenzae type b] Hib) should be included as an option in the Vaccines for Children (VFC) program for the infant series at ages 2, 4, and 6 months, according to unanimous votes at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
The addition of the vaccine to the VFC program required no motions on the part of the committee, but involved separate votes on each component of the vaccine.
Combination vaccination has been associated with increased coverage and more likely completion of the full infant vaccine series, said Sara Oliver, MD, of the CDC’s National Center for Immunization and Respiratory Diseases.
The new vaccine is being developed jointly by Sanofi and Merck, and has been approved by the Food and Drug Administration for use in children through age 4 years.
Dr. Oliver presented evidence that the safety profile of the combination vaccine is consistent with that of the component vaccines. In addition, “use of combination vaccines can reduce the number of injections patient receive and alleviate concern associated with the number of injections,” she said. However, “considerations should include provider assessment, patient preference, and the potential for adverse events.”
although it will not be available until 2021 in order to ensure sufficient supply, Dr. Oliver noted.
The combination vaccination work group considered whether the new vaccine should be preferentially recommended for American Indian and Alaskan Native populations, but they concluded that post–dose one immunogenicity data are needed before such a preferential recommendation can be made.
The ACIP members had no financial conflicts to disclose.
REPORTING FROM AN ACIP MEETING
ACIP favors shared decision on pneumococcal vaccine for older adults
Pneumococcal vaccination with the 13-valent pneumococcal conjugate vaccine (PCV13) based on shared clinical decision making is recommended for immunocompetent adults aged 65 years and older who have not previously received PCV13, and all adults aged 65 years and older should continue to receive the pneumococcal polysaccharide vaccine (PPSV23), according to a vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
The motion passed with an 11-1 vote after members voted down two other options to either discontinue or continue the current recommendation of PCV13 for all immunocompetent adults aged 65 years and older. The current recommendation for PCV13 for adults aged 65 years and older has been in place since 2014.
The pneumococcal work group assessed indirect effects of the pediatric PCV vaccination on older adults prior to 2014 and since 2014, and what additional benefits might be expected if routine vaccination of older adults continued.
“Indirect effects have been observed in all age groups” said Almea Matanock, MD, of the CDC’s National Center for Immunization and Respiratory Diseases. Although there were no safety concerns, the public health impact of continued vaccination of adults was minimal.
Although PCV13 resulted in a 75% reduction in vaccine-type invasive pneumococcal disease and a 45% reduction in vaccine-type nonbacteremic pneumonia in 2014, the annual number needed to vaccinate to prevent a single case of outpatient pneumonia was 2,600, said Dr. Matanock.
Dr. Matanock presented key issues from the Evidence to Recommendations Framework for and against the recommendation for PCV13 in older adults. Work group comments in favor of continuing the recommendation for PCV13 in older adults included effective disease prevention and the potential negative impact on the importance of adult vaccines if the vaccine was no longer recommended. However, some work group members and committee members expressed concern about resource allocation and steering vaccines away from younger age groups in whom they have been more consistently effective.
Paul Hunter, MD, of the City of Milwaukee Health Department, voted against the shared clinical decision making, and instead favored discontinuing the recommendation for PCV13 for older adults. “I think clinicians need a clear message,” he said, adding that “the public health bang for the buck is with the kids.”
“I think there was a recognition that the population level benefit is minimal,” said work group chair Grace Lee, MD.
Although the work group recognized some benefit for older adults, the burden of disease for PCV-specific disease is low, compared with all-cause pneumonia, said Dr. Lee of Lucile Packard Children’s Hospital at Stanford, Calif. However, the recommendation for shared clinical decision making allows for potential insurance coverage of the vaccine for adults who decide after discussion with their health care provider that they would benefit.
“We are still unpacking this construct” of shared clinical decision making, which in this case applies to adults without immunocompromising conditions, and is more of a provider assessment than a risk assessment, she said.
The ACIP members had no financial conflicts to disclose.
Pneumococcal vaccination with the 13-valent pneumococcal conjugate vaccine (PCV13) based on shared clinical decision making is recommended for immunocompetent adults aged 65 years and older who have not previously received PCV13, and all adults aged 65 years and older should continue to receive the pneumococcal polysaccharide vaccine (PPSV23), according to a vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
The motion passed with an 11-1 vote after members voted down two other options to either discontinue or continue the current recommendation of PCV13 for all immunocompetent adults aged 65 years and older. The current recommendation for PCV13 for adults aged 65 years and older has been in place since 2014.
The pneumococcal work group assessed indirect effects of the pediatric PCV vaccination on older adults prior to 2014 and since 2014, and what additional benefits might be expected if routine vaccination of older adults continued.
“Indirect effects have been observed in all age groups” said Almea Matanock, MD, of the CDC’s National Center for Immunization and Respiratory Diseases. Although there were no safety concerns, the public health impact of continued vaccination of adults was minimal.
Although PCV13 resulted in a 75% reduction in vaccine-type invasive pneumococcal disease and a 45% reduction in vaccine-type nonbacteremic pneumonia in 2014, the annual number needed to vaccinate to prevent a single case of outpatient pneumonia was 2,600, said Dr. Matanock.
Dr. Matanock presented key issues from the Evidence to Recommendations Framework for and against the recommendation for PCV13 in older adults. Work group comments in favor of continuing the recommendation for PCV13 in older adults included effective disease prevention and the potential negative impact on the importance of adult vaccines if the vaccine was no longer recommended. However, some work group members and committee members expressed concern about resource allocation and steering vaccines away from younger age groups in whom they have been more consistently effective.
Paul Hunter, MD, of the City of Milwaukee Health Department, voted against the shared clinical decision making, and instead favored discontinuing the recommendation for PCV13 for older adults. “I think clinicians need a clear message,” he said, adding that “the public health bang for the buck is with the kids.”
“I think there was a recognition that the population level benefit is minimal,” said work group chair Grace Lee, MD.
Although the work group recognized some benefit for older adults, the burden of disease for PCV-specific disease is low, compared with all-cause pneumonia, said Dr. Lee of Lucile Packard Children’s Hospital at Stanford, Calif. However, the recommendation for shared clinical decision making allows for potential insurance coverage of the vaccine for adults who decide after discussion with their health care provider that they would benefit.
“We are still unpacking this construct” of shared clinical decision making, which in this case applies to adults without immunocompromising conditions, and is more of a provider assessment than a risk assessment, she said.
The ACIP members had no financial conflicts to disclose.
Pneumococcal vaccination with the 13-valent pneumococcal conjugate vaccine (PCV13) based on shared clinical decision making is recommended for immunocompetent adults aged 65 years and older who have not previously received PCV13, and all adults aged 65 years and older should continue to receive the pneumococcal polysaccharide vaccine (PPSV23), according to a vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
The motion passed with an 11-1 vote after members voted down two other options to either discontinue or continue the current recommendation of PCV13 for all immunocompetent adults aged 65 years and older. The current recommendation for PCV13 for adults aged 65 years and older has been in place since 2014.
The pneumococcal work group assessed indirect effects of the pediatric PCV vaccination on older adults prior to 2014 and since 2014, and what additional benefits might be expected if routine vaccination of older adults continued.
“Indirect effects have been observed in all age groups” said Almea Matanock, MD, of the CDC’s National Center for Immunization and Respiratory Diseases. Although there were no safety concerns, the public health impact of continued vaccination of adults was minimal.
Although PCV13 resulted in a 75% reduction in vaccine-type invasive pneumococcal disease and a 45% reduction in vaccine-type nonbacteremic pneumonia in 2014, the annual number needed to vaccinate to prevent a single case of outpatient pneumonia was 2,600, said Dr. Matanock.
Dr. Matanock presented key issues from the Evidence to Recommendations Framework for and against the recommendation for PCV13 in older adults. Work group comments in favor of continuing the recommendation for PCV13 in older adults included effective disease prevention and the potential negative impact on the importance of adult vaccines if the vaccine was no longer recommended. However, some work group members and committee members expressed concern about resource allocation and steering vaccines away from younger age groups in whom they have been more consistently effective.
Paul Hunter, MD, of the City of Milwaukee Health Department, voted against the shared clinical decision making, and instead favored discontinuing the recommendation for PCV13 for older adults. “I think clinicians need a clear message,” he said, adding that “the public health bang for the buck is with the kids.”
“I think there was a recognition that the population level benefit is minimal,” said work group chair Grace Lee, MD.
Although the work group recognized some benefit for older adults, the burden of disease for PCV-specific disease is low, compared with all-cause pneumonia, said Dr. Lee of Lucile Packard Children’s Hospital at Stanford, Calif. However, the recommendation for shared clinical decision making allows for potential insurance coverage of the vaccine for adults who decide after discussion with their health care provider that they would benefit.
“We are still unpacking this construct” of shared clinical decision making, which in this case applies to adults without immunocompromising conditions, and is more of a provider assessment than a risk assessment, she said.
The ACIP members had no financial conflicts to disclose.
REPORTING FROM AN ACIP MEETING
ACIP extends HPV vaccine coverage
according to a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
This change affects males aged 22 through 26 years; the HPV vaccine is currently recommended for males and females aged 11 or 12 years, with catch-up vaccination through age 21 for males and age 26 for females.
The change was supported in part by increased interest in simplifying and harmonizing the vaccine schedule, said Lauri Markowitz, MD, of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), who presented the HPV work group’s considerations.
In addition, the committee voted 10-4 in favor of catch-up HPV vaccination, based on shared clinical decision making, for all adults aged 27 through 45 years.
Although the current program of HPV vaccination for youth has demonstrated effectiveness, data from multiple models suggest that widespread HPV vaccination for adults older than 26 years is much less cost effective, and would yield relatively small additional health benefits, Dr. Markowitz said.
The HPV work group reviewed data from a range of clinical trials, epidemiology, and natural history, as well as results from five different health economic models. They concluded that an assessment of benefits and harms favors expanding the catch-up vaccination to all individuals through 26 years, said Elissa Meites, MD, of the CDC, who presented the official work group opinion. The group’s opinion on the second question was that the additional population level benefit of expanding HPV vaccination to all adults would be minimal and not a reasonable and effective allocation of resources, but that shared clinical decision making would allow flexibility.
The committee expressed strong opinions about the potential for shared clinical decision making as a policy for vaccination for adults older than 26 years. Some felt that this option was a way to include adults at risk for HPV, such as divorced women with new partners, or women getting married for the first time later in life who might not have been exposed to HPV through other relationships. In addition, supporters noted that the shared clinical decision-making option would allow for potential insurance coverage, and would involve discussion between doctors and patients to assess risk.
However, other committee members felt that any recommendation for older adult vaccination would distract clinicians from the importance and value of HPV vaccination for the target age group of 11- and 12-year-olds, and might divert resources from the younger age group in whom it has shown the most benefit.
Resource allocation was a concern voiced by many committee members. Kelly Moore, MD, MPH, of Vanderbilt University, Nashville, Tenn., said she voted no on expanding vaccination to older adults because “we didn’t have details on shared clinical decision making, in the absence of information on what that meant, and in the presence of supply questions, I didn’t feel comfortable expanding vaccination to a huge population,” she said.
Paul Hunter, MD, of the City of Milwaukee Health Department, also voted no, and expressed concern that expanding the HPV vaccination recommendations to older adults would send the message that vaccination for children and teens is not effective or important.
The text of the new recommendations for routine and catch-up vaccination states that the recommendations “also apply to MSM [men who have sex with men], transgender people, and people with immunocompromising conditions.”
The ACIP members had no financial conflicts to disclose.
according to a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
This change affects males aged 22 through 26 years; the HPV vaccine is currently recommended for males and females aged 11 or 12 years, with catch-up vaccination through age 21 for males and age 26 for females.
The change was supported in part by increased interest in simplifying and harmonizing the vaccine schedule, said Lauri Markowitz, MD, of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), who presented the HPV work group’s considerations.
In addition, the committee voted 10-4 in favor of catch-up HPV vaccination, based on shared clinical decision making, for all adults aged 27 through 45 years.
Although the current program of HPV vaccination for youth has demonstrated effectiveness, data from multiple models suggest that widespread HPV vaccination for adults older than 26 years is much less cost effective, and would yield relatively small additional health benefits, Dr. Markowitz said.
The HPV work group reviewed data from a range of clinical trials, epidemiology, and natural history, as well as results from five different health economic models. They concluded that an assessment of benefits and harms favors expanding the catch-up vaccination to all individuals through 26 years, said Elissa Meites, MD, of the CDC, who presented the official work group opinion. The group’s opinion on the second question was that the additional population level benefit of expanding HPV vaccination to all adults would be minimal and not a reasonable and effective allocation of resources, but that shared clinical decision making would allow flexibility.
The committee expressed strong opinions about the potential for shared clinical decision making as a policy for vaccination for adults older than 26 years. Some felt that this option was a way to include adults at risk for HPV, such as divorced women with new partners, or women getting married for the first time later in life who might not have been exposed to HPV through other relationships. In addition, supporters noted that the shared clinical decision-making option would allow for potential insurance coverage, and would involve discussion between doctors and patients to assess risk.
However, other committee members felt that any recommendation for older adult vaccination would distract clinicians from the importance and value of HPV vaccination for the target age group of 11- and 12-year-olds, and might divert resources from the younger age group in whom it has shown the most benefit.
Resource allocation was a concern voiced by many committee members. Kelly Moore, MD, MPH, of Vanderbilt University, Nashville, Tenn., said she voted no on expanding vaccination to older adults because “we didn’t have details on shared clinical decision making, in the absence of information on what that meant, and in the presence of supply questions, I didn’t feel comfortable expanding vaccination to a huge population,” she said.
Paul Hunter, MD, of the City of Milwaukee Health Department, also voted no, and expressed concern that expanding the HPV vaccination recommendations to older adults would send the message that vaccination for children and teens is not effective or important.
The text of the new recommendations for routine and catch-up vaccination states that the recommendations “also apply to MSM [men who have sex with men], transgender people, and people with immunocompromising conditions.”
The ACIP members had no financial conflicts to disclose.
according to a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
This change affects males aged 22 through 26 years; the HPV vaccine is currently recommended for males and females aged 11 or 12 years, with catch-up vaccination through age 21 for males and age 26 for females.
The change was supported in part by increased interest in simplifying and harmonizing the vaccine schedule, said Lauri Markowitz, MD, of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), who presented the HPV work group’s considerations.
In addition, the committee voted 10-4 in favor of catch-up HPV vaccination, based on shared clinical decision making, for all adults aged 27 through 45 years.
Although the current program of HPV vaccination for youth has demonstrated effectiveness, data from multiple models suggest that widespread HPV vaccination for adults older than 26 years is much less cost effective, and would yield relatively small additional health benefits, Dr. Markowitz said.
The HPV work group reviewed data from a range of clinical trials, epidemiology, and natural history, as well as results from five different health economic models. They concluded that an assessment of benefits and harms favors expanding the catch-up vaccination to all individuals through 26 years, said Elissa Meites, MD, of the CDC, who presented the official work group opinion. The group’s opinion on the second question was that the additional population level benefit of expanding HPV vaccination to all adults would be minimal and not a reasonable and effective allocation of resources, but that shared clinical decision making would allow flexibility.
The committee expressed strong opinions about the potential for shared clinical decision making as a policy for vaccination for adults older than 26 years. Some felt that this option was a way to include adults at risk for HPV, such as divorced women with new partners, or women getting married for the first time later in life who might not have been exposed to HPV through other relationships. In addition, supporters noted that the shared clinical decision-making option would allow for potential insurance coverage, and would involve discussion between doctors and patients to assess risk.
However, other committee members felt that any recommendation for older adult vaccination would distract clinicians from the importance and value of HPV vaccination for the target age group of 11- and 12-year-olds, and might divert resources from the younger age group in whom it has shown the most benefit.
Resource allocation was a concern voiced by many committee members. Kelly Moore, MD, MPH, of Vanderbilt University, Nashville, Tenn., said she voted no on expanding vaccination to older adults because “we didn’t have details on shared clinical decision making, in the absence of information on what that meant, and in the presence of supply questions, I didn’t feel comfortable expanding vaccination to a huge population,” she said.
Paul Hunter, MD, of the City of Milwaukee Health Department, also voted no, and expressed concern that expanding the HPV vaccination recommendations to older adults would send the message that vaccination for children and teens is not effective or important.
The text of the new recommendations for routine and catch-up vaccination states that the recommendations “also apply to MSM [men who have sex with men], transgender people, and people with immunocompromising conditions.”
The ACIP members had no financial conflicts to disclose.
REPORTING FROM AN ACIP MEETING
Substantial reductions in HPV infections, CIN2+ after vaccination
The introduction of the human papillomavirus according to a meta-analysis of data from more than 60 million individuals worldwide.
Mélanie Drolet, PhD, from the Centre de recherche du CHU de Québec–Université Laval, and coauthors of the HPV Vaccination Impact Study Group reported the results of a systematic review and meta-analysis of 65 studies showing pre- and postvaccination frequency of at least one HPV-related endpoint published in the Lancet. The studies were conducted in 14 high-income countries, 12 of which were vaccinating only women and girls, with the results at 5-8 years published in the Lancet.
At 5-8 years after a vaccination program was implemented, there was a significant 83% reduction in the prevalence of HPV 16 and 18, both of which are targeted by the vaccine, among girls aged 13-19 years; a 66% reduction among women aged 20-24 years; and a 37% reduction in women aged 25-29 years, even though most of these women were unvaccinated.
There also were significant decreases at 5-8 years in the prevalence of HPV subtypes 31, 33, and 45, which are not included in the vaccine but against which the vaccine appears to offer cross-protection. Among girls aged 13-19 years, there was a significant 54% reduction in the prevalence of these subtypes, among women aged 20-24 years there was a nonsignificant 28% decrease, but among women aged 25-29 years, there was no significant decrease.
The analysis also found significant declines in the prevalence of cervical intraepithelial neoplasias (CINs) of grade 2 or above. At 5-9 years after vaccination was introduced, CIN2+ decreased by 51% among girls aged 15-19 years who also were screened for cervical cancer, and by 31% among women aged 20-24 years.
However, over the same time period, the rates of CIN2+ increased by a significant 19% among mostly unvaccinated women aged 25-29 years and 23% among mostly unvaccinated women aged 30-39 years, despite both groups being screened for cervical abnormalities.
While most of the countries in the study vaccinated only girls and women, two studies did find nonsignificant decreases in the prevalence of HPV 16, 18, 31, 33, and 45 among boys aged 16-19 years, but not among men aged 20-24 years.
HPV vaccination also was associated with significant declines in the incidence of anogenital warts among both males and females. In the first 4 years alone, vaccination was associated with significant reductions in anogenital wart diagnoses among females aged 15-29 years, as well as nonsignificant but “substantial” reductions in unvaccinated boys aged 15-19 years.
After 5-8 years, anogenital wart diagnoses decreased by 67% among girls aged 15-19 years, significantly by 54% among women aged 20-24 years, and 31% among women aged 25-29 years – all significant changes. Among boys aged 15-19 years, anogenital wart diagnoses decreased by a significant 48%, and among men aged 20-24 years they decreased by a significant 32%.
The decreases in anogenital wart diagnoses were even greater in countries that implemented vaccination among multiple cohorts simultaneously and achieved high vaccination coverage, compared with countries that vaccinated only one cohort at a time or had low routine vaccination coverage.
“Our study is the first to show the real-world additional benefit of multicohort HPV vaccination and high routine vaccination coverage, and the fast and substantial herd effects of vaccination in countries which implement these measures,” wrote Dr. Drolet and coauthors. “The greater impact of multicohort vaccination was similar when restricting the analyses to countries with high routine vaccination coverage.”
They pointed to the World Health Organization’s recently revised position on HPV vaccination, which now recommends vaccination of multiple cohorts of girls aged 9-14 years, although they raised the question of what might be the optimal number of age cohorts. “Number needed to vaccinate and cost-effectiveness analyses in high-income countries suggest that vaccinating multiple cohorts of individuals up to 18 years of age is highly efficient and cost effective.”
This analysis by Drolet et al. “provides compelling evidence for HPV vaccine efficacy on all outcomes explored and for almost all age strata,” Dr. Silvia de Sanjose, of PATH in Seattle, and Dr. Sinead Delany-Moretlwe of the Wits Reproductive Health and HIV Institute at the University of Witwatersrand in Johannesburg, said in an accompanying editorial (Lancet. 2019 Jun 26. doi: 10.1016/ S0140-6736[19]30549-5). This study shows just how effective HPV vaccination can be across a range of outcomes and ages, and also demonstrates the herd immunity benefits, particularly when multiple cohorts are vaccinated and there is high vaccination coverage.
One key limitation of this analysis is the lack of data from low- and middle-income countries. The data by Drolet et al. “emphasise the importance of redoubling our efforts to tackle the fiscal, supply, and programmatic barriers that currently limit HPV vaccine programmes; with these efforts, HPV vaccination could become a hallmark investment of cancer prevention in the 21st century,” Dr. de Sanjose and Dr. Delany-Moretlwe concluded.
The study was funded by WHO, Canadian Institutes of Health Research, and Fonds de recherche du Québec–Santé. No conflicts of interest were declared.
Dr. de Sanjose declared previous institutional support from Merck.
SOURCE: Drolet M et al. Lancet 2019 Jun 26. doi: 10.1016/ S0140-6736(19)30298-3.
The introduction of the human papillomavirus according to a meta-analysis of data from more than 60 million individuals worldwide.
Mélanie Drolet, PhD, from the Centre de recherche du CHU de Québec–Université Laval, and coauthors of the HPV Vaccination Impact Study Group reported the results of a systematic review and meta-analysis of 65 studies showing pre- and postvaccination frequency of at least one HPV-related endpoint published in the Lancet. The studies were conducted in 14 high-income countries, 12 of which were vaccinating only women and girls, with the results at 5-8 years published in the Lancet.
At 5-8 years after a vaccination program was implemented, there was a significant 83% reduction in the prevalence of HPV 16 and 18, both of which are targeted by the vaccine, among girls aged 13-19 years; a 66% reduction among women aged 20-24 years; and a 37% reduction in women aged 25-29 years, even though most of these women were unvaccinated.
There also were significant decreases at 5-8 years in the prevalence of HPV subtypes 31, 33, and 45, which are not included in the vaccine but against which the vaccine appears to offer cross-protection. Among girls aged 13-19 years, there was a significant 54% reduction in the prevalence of these subtypes, among women aged 20-24 years there was a nonsignificant 28% decrease, but among women aged 25-29 years, there was no significant decrease.
The analysis also found significant declines in the prevalence of cervical intraepithelial neoplasias (CINs) of grade 2 or above. At 5-9 years after vaccination was introduced, CIN2+ decreased by 51% among girls aged 15-19 years who also were screened for cervical cancer, and by 31% among women aged 20-24 years.
However, over the same time period, the rates of CIN2+ increased by a significant 19% among mostly unvaccinated women aged 25-29 years and 23% among mostly unvaccinated women aged 30-39 years, despite both groups being screened for cervical abnormalities.
While most of the countries in the study vaccinated only girls and women, two studies did find nonsignificant decreases in the prevalence of HPV 16, 18, 31, 33, and 45 among boys aged 16-19 years, but not among men aged 20-24 years.
HPV vaccination also was associated with significant declines in the incidence of anogenital warts among both males and females. In the first 4 years alone, vaccination was associated with significant reductions in anogenital wart diagnoses among females aged 15-29 years, as well as nonsignificant but “substantial” reductions in unvaccinated boys aged 15-19 years.
After 5-8 years, anogenital wart diagnoses decreased by 67% among girls aged 15-19 years, significantly by 54% among women aged 20-24 years, and 31% among women aged 25-29 years – all significant changes. Among boys aged 15-19 years, anogenital wart diagnoses decreased by a significant 48%, and among men aged 20-24 years they decreased by a significant 32%.
The decreases in anogenital wart diagnoses were even greater in countries that implemented vaccination among multiple cohorts simultaneously and achieved high vaccination coverage, compared with countries that vaccinated only one cohort at a time or had low routine vaccination coverage.
“Our study is the first to show the real-world additional benefit of multicohort HPV vaccination and high routine vaccination coverage, and the fast and substantial herd effects of vaccination in countries which implement these measures,” wrote Dr. Drolet and coauthors. “The greater impact of multicohort vaccination was similar when restricting the analyses to countries with high routine vaccination coverage.”
They pointed to the World Health Organization’s recently revised position on HPV vaccination, which now recommends vaccination of multiple cohorts of girls aged 9-14 years, although they raised the question of what might be the optimal number of age cohorts. “Number needed to vaccinate and cost-effectiveness analyses in high-income countries suggest that vaccinating multiple cohorts of individuals up to 18 years of age is highly efficient and cost effective.”
This analysis by Drolet et al. “provides compelling evidence for HPV vaccine efficacy on all outcomes explored and for almost all age strata,” Dr. Silvia de Sanjose, of PATH in Seattle, and Dr. Sinead Delany-Moretlwe of the Wits Reproductive Health and HIV Institute at the University of Witwatersrand in Johannesburg, said in an accompanying editorial (Lancet. 2019 Jun 26. doi: 10.1016/ S0140-6736[19]30549-5). This study shows just how effective HPV vaccination can be across a range of outcomes and ages, and also demonstrates the herd immunity benefits, particularly when multiple cohorts are vaccinated and there is high vaccination coverage.
One key limitation of this analysis is the lack of data from low- and middle-income countries. The data by Drolet et al. “emphasise the importance of redoubling our efforts to tackle the fiscal, supply, and programmatic barriers that currently limit HPV vaccine programmes; with these efforts, HPV vaccination could become a hallmark investment of cancer prevention in the 21st century,” Dr. de Sanjose and Dr. Delany-Moretlwe concluded.
The study was funded by WHO, Canadian Institutes of Health Research, and Fonds de recherche du Québec–Santé. No conflicts of interest were declared.
Dr. de Sanjose declared previous institutional support from Merck.
SOURCE: Drolet M et al. Lancet 2019 Jun 26. doi: 10.1016/ S0140-6736(19)30298-3.
The introduction of the human papillomavirus according to a meta-analysis of data from more than 60 million individuals worldwide.
Mélanie Drolet, PhD, from the Centre de recherche du CHU de Québec–Université Laval, and coauthors of the HPV Vaccination Impact Study Group reported the results of a systematic review and meta-analysis of 65 studies showing pre- and postvaccination frequency of at least one HPV-related endpoint published in the Lancet. The studies were conducted in 14 high-income countries, 12 of which were vaccinating only women and girls, with the results at 5-8 years published in the Lancet.
At 5-8 years after a vaccination program was implemented, there was a significant 83% reduction in the prevalence of HPV 16 and 18, both of which are targeted by the vaccine, among girls aged 13-19 years; a 66% reduction among women aged 20-24 years; and a 37% reduction in women aged 25-29 years, even though most of these women were unvaccinated.
There also were significant decreases at 5-8 years in the prevalence of HPV subtypes 31, 33, and 45, which are not included in the vaccine but against which the vaccine appears to offer cross-protection. Among girls aged 13-19 years, there was a significant 54% reduction in the prevalence of these subtypes, among women aged 20-24 years there was a nonsignificant 28% decrease, but among women aged 25-29 years, there was no significant decrease.
The analysis also found significant declines in the prevalence of cervical intraepithelial neoplasias (CINs) of grade 2 or above. At 5-9 years after vaccination was introduced, CIN2+ decreased by 51% among girls aged 15-19 years who also were screened for cervical cancer, and by 31% among women aged 20-24 years.
However, over the same time period, the rates of CIN2+ increased by a significant 19% among mostly unvaccinated women aged 25-29 years and 23% among mostly unvaccinated women aged 30-39 years, despite both groups being screened for cervical abnormalities.
While most of the countries in the study vaccinated only girls and women, two studies did find nonsignificant decreases in the prevalence of HPV 16, 18, 31, 33, and 45 among boys aged 16-19 years, but not among men aged 20-24 years.
HPV vaccination also was associated with significant declines in the incidence of anogenital warts among both males and females. In the first 4 years alone, vaccination was associated with significant reductions in anogenital wart diagnoses among females aged 15-29 years, as well as nonsignificant but “substantial” reductions in unvaccinated boys aged 15-19 years.
After 5-8 years, anogenital wart diagnoses decreased by 67% among girls aged 15-19 years, significantly by 54% among women aged 20-24 years, and 31% among women aged 25-29 years – all significant changes. Among boys aged 15-19 years, anogenital wart diagnoses decreased by a significant 48%, and among men aged 20-24 years they decreased by a significant 32%.
The decreases in anogenital wart diagnoses were even greater in countries that implemented vaccination among multiple cohorts simultaneously and achieved high vaccination coverage, compared with countries that vaccinated only one cohort at a time or had low routine vaccination coverage.
“Our study is the first to show the real-world additional benefit of multicohort HPV vaccination and high routine vaccination coverage, and the fast and substantial herd effects of vaccination in countries which implement these measures,” wrote Dr. Drolet and coauthors. “The greater impact of multicohort vaccination was similar when restricting the analyses to countries with high routine vaccination coverage.”
They pointed to the World Health Organization’s recently revised position on HPV vaccination, which now recommends vaccination of multiple cohorts of girls aged 9-14 years, although they raised the question of what might be the optimal number of age cohorts. “Number needed to vaccinate and cost-effectiveness analyses in high-income countries suggest that vaccinating multiple cohorts of individuals up to 18 years of age is highly efficient and cost effective.”
This analysis by Drolet et al. “provides compelling evidence for HPV vaccine efficacy on all outcomes explored and for almost all age strata,” Dr. Silvia de Sanjose, of PATH in Seattle, and Dr. Sinead Delany-Moretlwe of the Wits Reproductive Health and HIV Institute at the University of Witwatersrand in Johannesburg, said in an accompanying editorial (Lancet. 2019 Jun 26. doi: 10.1016/ S0140-6736[19]30549-5). This study shows just how effective HPV vaccination can be across a range of outcomes and ages, and also demonstrates the herd immunity benefits, particularly when multiple cohorts are vaccinated and there is high vaccination coverage.
One key limitation of this analysis is the lack of data from low- and middle-income countries. The data by Drolet et al. “emphasise the importance of redoubling our efforts to tackle the fiscal, supply, and programmatic barriers that currently limit HPV vaccine programmes; with these efforts, HPV vaccination could become a hallmark investment of cancer prevention in the 21st century,” Dr. de Sanjose and Dr. Delany-Moretlwe concluded.
The study was funded by WHO, Canadian Institutes of Health Research, and Fonds de recherche du Québec–Santé. No conflicts of interest were declared.
Dr. de Sanjose declared previous institutional support from Merck.
SOURCE: Drolet M et al. Lancet 2019 Jun 26. doi: 10.1016/ S0140-6736(19)30298-3.
FROM THE LANCET
Key clinical point: Significant declines in HPV infections, CIN2+, and anogenital warts have occurred after the introduction of HPV vaccine programs, some because of herd effects.
Major finding: The HPV vaccination program is associated with a significant 83% reduction in the prevalence of HPV 16 and 18 among girls aged 13-19 years in 14 high-income countries.
Study details: Systematic review and meta-analysis of 65 studies involving more than 60 million individuals in 14 countries.
Disclosures: The study was funded by World Health Organization, Canadian Institutes of Health Research, and Fonds de recherche du Québec – Santé. No conflicts of interest were declared.
Source: Drolet M et al. Lancet 2019 Jun 26. doi: 10.1016/ S0140-6736(19)30298-3.
What’s new in pediatric sepsis
LJUBLJANA, SLOVENIA – The dogma of the “Golden Hour” for the immediate management of pediatric sepsis has been oversold and actually is based upon weak evidence, Luregn J. Schlapbach, MD, asserted at the annual meeting of the European Society for Paediatric Infectious Diseases.
The true Golden Hour – that is, the time frame within which it’s imperative to administer the sepsis bundle comprised of appropriate antibiotics, fluids, and inotropes – is probably more like 3 hours.
“The evidence suggests that up to 3 hours you don’t really have a big difference in outcomes for sepsis. If you recognize shock there’s no question: You should not even wait 1 hour. But if you’re not certain, it may be better to give up to 3 hours to work up the child and get the senior clinician involved before you make decisions about treatment. So I’m not advocating to delay anything, said Dr. Schlapbach, a pediatric intensivist at the Child Health Research Center at the University of Queensland in South Brisbane, Australia.
The problem with a 1-hour mandate for delivery of the sepsis bundle, as recommended in guidelines by the Surviving Sepsis Campaign and the American College of Critical Care Medicine, and endorsed in quality improvement initiatives, is that the time pressure pushes physicians to overprescribe antibiotics to children who don’t actually have a serious bacterial infection. And that, he noted, contributes to the growing problem of antimicrobial resistance.
“You may have a child where you’re not too sure. Usually you would have done a urine culture because UTI [urinary tract infection] is quite a common cause of these infections, and many of these kids aren’t necessarily septic. But if people tell you that within 1 hour you need to treat, are you going to take the time to do the urine culture, or are you just going to decide to treat?” he asked rhetorically.
Dr. Schlapbach is a world-renowned pediatric sepsis researcher. He is far from alone in his reservations about the Golden Hour mandate.
“This is one of the reasons why IDSA [the Infectious Diseases Society of America] has not endorsed the Surviving Sepsis Campaign,” according to the physician, who noted that, in a position statement, IDSA officials have declared that discrimination of sepsis from noninfectious conditions remains a challenge, and that a 60-minute time to antibiotics may jeopardize patient reassessment (Clin Infect Dis. 2018 May 15;66[10]:1631-5).
Dr. Schlapbach highlighted other recent developments in pediatric sepsis.
The definition of adult sepsis has changed, and the pediatric version needs to as well
The revised definition of sepsis, known as Sepsis-3, issued by the International Sepsis Definition Task Force in 2016 notably dropped systemic inflammatory response syndrome (SIRS), as a requirement for sepsis (JAMA. 2016;315[8]:801-10). The revised definition characterizes sepsis as a dysregulated host response to infection resulting in life-threatening organ dysfunction. But Sepsis-3 is based entirely on adult data and is not considered applicable to children.
The current Pediatric Sepsis Consensus Conference definition dates back to 2005. A comprehensive revision is getting underway. It, too, is likely to drop SIRS into the wastebasket, Dr. Schlapbach said.
“It is probably time to abandon the old view of sepsis disease progression, which proposes a progression from infection to SIRS to severe sepsis with organ dysfunction to septic shock, because most children with infection do manifest signs of SIRS, such as tachycardia, tachypnea, and fever, and these probably should be considered as more of an adaptive rather than a maladaptive response,” he explained.
The goal of the pediatric sepsis redefinition project is to come up with something more useful for clinicians than the Sepsis-3 definition. While the Sepsis-3 concept of a dysregulated host response to infection sounds nice, he explained, “we don’t actually know what it is.
“One of the challenges that you all know as pediatricians is that children who develop sepsis get sick very, very quickly. We all have memories of children who we saw and may have discharged, and they were dead 12 hours later,” he noted.
Indeed, he and others have shown in multiple studies that up to 50% of pediatric deaths caused by sepsis happen within 24 hours of presentation.
“So whatever happens, it happens very quickly. The true question for us is actually how and why do children progress from no organ dysfunction, where the mortality is close to zero, to organ dysfunction, where all of a sudden mortality jumps up dramatically. It’s this progression that we don’t understand at all,” according to Dr. Schlapbach.
The genetic contribution to fulminant sepsis in children may be substantial
One-third of pediatric sepsis deaths in high-income countries happen in previously healthy children. In a proof-of-concept study, Dr. Schlapbach and coinvestigators in the Swiss Pediatric Sepsis Study Group conducted exome-sequencing genetic studies in eight previously healthy children with no family history of immunodeficiency who died of severe sepsis because of community-acquired Pseudomonas aeruginosa infection. Two of the eight had rare loss-of-function mutations in genes known to cause primary immunodeficiencies. The investigators proposed that unusually severe sepsis in previously healthy children warrants exome sequencing to look for underlying previously undetected primary immunodeficiencies. That’s important information for survivors and/or affected families to have, they argued (Front Immunol. 2016 Sep 20;7:357. eCollection 2016).
“There are some indications that the genetic contribution in children with sepsis may be larger than previously assumed,” he said.
The longstanding practice of fluid bolus therapy for resuscitation in pediatric sepsis is being reexamined
The FEAST (Fluid Expansion As Supportive Therapy) study, a randomized trial of more than 3,000 children with severe febrile illness and impaired perfusion in sub-Saharan Africa, turned heads with its finding that fluid boluses significantly increased 48-hour mortality (BMC Med. 2013 Mar 14;11:67).
Indeed, the FEAST findings, supported by mechanistic animal studies, were sufficiently compelling that the use of fluid boluses in both pediatric and adult septic shock is now under scrutiny in two major randomized trials: RIFTS (the Restrictive IV Fluid Trial in Severe Sepsis and Septic Shock), and CLOVERS (Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis). Stay tuned.
Dr. Schlapbach reported having no financial conflicts regarding his presentation.
LJUBLJANA, SLOVENIA – The dogma of the “Golden Hour” for the immediate management of pediatric sepsis has been oversold and actually is based upon weak evidence, Luregn J. Schlapbach, MD, asserted at the annual meeting of the European Society for Paediatric Infectious Diseases.
The true Golden Hour – that is, the time frame within which it’s imperative to administer the sepsis bundle comprised of appropriate antibiotics, fluids, and inotropes – is probably more like 3 hours.
“The evidence suggests that up to 3 hours you don’t really have a big difference in outcomes for sepsis. If you recognize shock there’s no question: You should not even wait 1 hour. But if you’re not certain, it may be better to give up to 3 hours to work up the child and get the senior clinician involved before you make decisions about treatment. So I’m not advocating to delay anything, said Dr. Schlapbach, a pediatric intensivist at the Child Health Research Center at the University of Queensland in South Brisbane, Australia.
The problem with a 1-hour mandate for delivery of the sepsis bundle, as recommended in guidelines by the Surviving Sepsis Campaign and the American College of Critical Care Medicine, and endorsed in quality improvement initiatives, is that the time pressure pushes physicians to overprescribe antibiotics to children who don’t actually have a serious bacterial infection. And that, he noted, contributes to the growing problem of antimicrobial resistance.
“You may have a child where you’re not too sure. Usually you would have done a urine culture because UTI [urinary tract infection] is quite a common cause of these infections, and many of these kids aren’t necessarily septic. But if people tell you that within 1 hour you need to treat, are you going to take the time to do the urine culture, or are you just going to decide to treat?” he asked rhetorically.
Dr. Schlapbach is a world-renowned pediatric sepsis researcher. He is far from alone in his reservations about the Golden Hour mandate.
“This is one of the reasons why IDSA [the Infectious Diseases Society of America] has not endorsed the Surviving Sepsis Campaign,” according to the physician, who noted that, in a position statement, IDSA officials have declared that discrimination of sepsis from noninfectious conditions remains a challenge, and that a 60-minute time to antibiotics may jeopardize patient reassessment (Clin Infect Dis. 2018 May 15;66[10]:1631-5).
Dr. Schlapbach highlighted other recent developments in pediatric sepsis.
The definition of adult sepsis has changed, and the pediatric version needs to as well
The revised definition of sepsis, known as Sepsis-3, issued by the International Sepsis Definition Task Force in 2016 notably dropped systemic inflammatory response syndrome (SIRS), as a requirement for sepsis (JAMA. 2016;315[8]:801-10). The revised definition characterizes sepsis as a dysregulated host response to infection resulting in life-threatening organ dysfunction. But Sepsis-3 is based entirely on adult data and is not considered applicable to children.
The current Pediatric Sepsis Consensus Conference definition dates back to 2005. A comprehensive revision is getting underway. It, too, is likely to drop SIRS into the wastebasket, Dr. Schlapbach said.
“It is probably time to abandon the old view of sepsis disease progression, which proposes a progression from infection to SIRS to severe sepsis with organ dysfunction to septic shock, because most children with infection do manifest signs of SIRS, such as tachycardia, tachypnea, and fever, and these probably should be considered as more of an adaptive rather than a maladaptive response,” he explained.
The goal of the pediatric sepsis redefinition project is to come up with something more useful for clinicians than the Sepsis-3 definition. While the Sepsis-3 concept of a dysregulated host response to infection sounds nice, he explained, “we don’t actually know what it is.
“One of the challenges that you all know as pediatricians is that children who develop sepsis get sick very, very quickly. We all have memories of children who we saw and may have discharged, and they were dead 12 hours later,” he noted.
Indeed, he and others have shown in multiple studies that up to 50% of pediatric deaths caused by sepsis happen within 24 hours of presentation.
“So whatever happens, it happens very quickly. The true question for us is actually how and why do children progress from no organ dysfunction, where the mortality is close to zero, to organ dysfunction, where all of a sudden mortality jumps up dramatically. It’s this progression that we don’t understand at all,” according to Dr. Schlapbach.
The genetic contribution to fulminant sepsis in children may be substantial
One-third of pediatric sepsis deaths in high-income countries happen in previously healthy children. In a proof-of-concept study, Dr. Schlapbach and coinvestigators in the Swiss Pediatric Sepsis Study Group conducted exome-sequencing genetic studies in eight previously healthy children with no family history of immunodeficiency who died of severe sepsis because of community-acquired Pseudomonas aeruginosa infection. Two of the eight had rare loss-of-function mutations in genes known to cause primary immunodeficiencies. The investigators proposed that unusually severe sepsis in previously healthy children warrants exome sequencing to look for underlying previously undetected primary immunodeficiencies. That’s important information for survivors and/or affected families to have, they argued (Front Immunol. 2016 Sep 20;7:357. eCollection 2016).
“There are some indications that the genetic contribution in children with sepsis may be larger than previously assumed,” he said.
The longstanding practice of fluid bolus therapy for resuscitation in pediatric sepsis is being reexamined
The FEAST (Fluid Expansion As Supportive Therapy) study, a randomized trial of more than 3,000 children with severe febrile illness and impaired perfusion in sub-Saharan Africa, turned heads with its finding that fluid boluses significantly increased 48-hour mortality (BMC Med. 2013 Mar 14;11:67).
Indeed, the FEAST findings, supported by mechanistic animal studies, were sufficiently compelling that the use of fluid boluses in both pediatric and adult septic shock is now under scrutiny in two major randomized trials: RIFTS (the Restrictive IV Fluid Trial in Severe Sepsis and Septic Shock), and CLOVERS (Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis). Stay tuned.
Dr. Schlapbach reported having no financial conflicts regarding his presentation.
LJUBLJANA, SLOVENIA – The dogma of the “Golden Hour” for the immediate management of pediatric sepsis has been oversold and actually is based upon weak evidence, Luregn J. Schlapbach, MD, asserted at the annual meeting of the European Society for Paediatric Infectious Diseases.
The true Golden Hour – that is, the time frame within which it’s imperative to administer the sepsis bundle comprised of appropriate antibiotics, fluids, and inotropes – is probably more like 3 hours.
“The evidence suggests that up to 3 hours you don’t really have a big difference in outcomes for sepsis. If you recognize shock there’s no question: You should not even wait 1 hour. But if you’re not certain, it may be better to give up to 3 hours to work up the child and get the senior clinician involved before you make decisions about treatment. So I’m not advocating to delay anything, said Dr. Schlapbach, a pediatric intensivist at the Child Health Research Center at the University of Queensland in South Brisbane, Australia.
The problem with a 1-hour mandate for delivery of the sepsis bundle, as recommended in guidelines by the Surviving Sepsis Campaign and the American College of Critical Care Medicine, and endorsed in quality improvement initiatives, is that the time pressure pushes physicians to overprescribe antibiotics to children who don’t actually have a serious bacterial infection. And that, he noted, contributes to the growing problem of antimicrobial resistance.
“You may have a child where you’re not too sure. Usually you would have done a urine culture because UTI [urinary tract infection] is quite a common cause of these infections, and many of these kids aren’t necessarily septic. But if people tell you that within 1 hour you need to treat, are you going to take the time to do the urine culture, or are you just going to decide to treat?” he asked rhetorically.
Dr. Schlapbach is a world-renowned pediatric sepsis researcher. He is far from alone in his reservations about the Golden Hour mandate.
“This is one of the reasons why IDSA [the Infectious Diseases Society of America] has not endorsed the Surviving Sepsis Campaign,” according to the physician, who noted that, in a position statement, IDSA officials have declared that discrimination of sepsis from noninfectious conditions remains a challenge, and that a 60-minute time to antibiotics may jeopardize patient reassessment (Clin Infect Dis. 2018 May 15;66[10]:1631-5).
Dr. Schlapbach highlighted other recent developments in pediatric sepsis.
The definition of adult sepsis has changed, and the pediatric version needs to as well
The revised definition of sepsis, known as Sepsis-3, issued by the International Sepsis Definition Task Force in 2016 notably dropped systemic inflammatory response syndrome (SIRS), as a requirement for sepsis (JAMA. 2016;315[8]:801-10). The revised definition characterizes sepsis as a dysregulated host response to infection resulting in life-threatening organ dysfunction. But Sepsis-3 is based entirely on adult data and is not considered applicable to children.
The current Pediatric Sepsis Consensus Conference definition dates back to 2005. A comprehensive revision is getting underway. It, too, is likely to drop SIRS into the wastebasket, Dr. Schlapbach said.
“It is probably time to abandon the old view of sepsis disease progression, which proposes a progression from infection to SIRS to severe sepsis with organ dysfunction to septic shock, because most children with infection do manifest signs of SIRS, such as tachycardia, tachypnea, and fever, and these probably should be considered as more of an adaptive rather than a maladaptive response,” he explained.
The goal of the pediatric sepsis redefinition project is to come up with something more useful for clinicians than the Sepsis-3 definition. While the Sepsis-3 concept of a dysregulated host response to infection sounds nice, he explained, “we don’t actually know what it is.
“One of the challenges that you all know as pediatricians is that children who develop sepsis get sick very, very quickly. We all have memories of children who we saw and may have discharged, and they were dead 12 hours later,” he noted.
Indeed, he and others have shown in multiple studies that up to 50% of pediatric deaths caused by sepsis happen within 24 hours of presentation.
“So whatever happens, it happens very quickly. The true question for us is actually how and why do children progress from no organ dysfunction, where the mortality is close to zero, to organ dysfunction, where all of a sudden mortality jumps up dramatically. It’s this progression that we don’t understand at all,” according to Dr. Schlapbach.
The genetic contribution to fulminant sepsis in children may be substantial
One-third of pediatric sepsis deaths in high-income countries happen in previously healthy children. In a proof-of-concept study, Dr. Schlapbach and coinvestigators in the Swiss Pediatric Sepsis Study Group conducted exome-sequencing genetic studies in eight previously healthy children with no family history of immunodeficiency who died of severe sepsis because of community-acquired Pseudomonas aeruginosa infection. Two of the eight had rare loss-of-function mutations in genes known to cause primary immunodeficiencies. The investigators proposed that unusually severe sepsis in previously healthy children warrants exome sequencing to look for underlying previously undetected primary immunodeficiencies. That’s important information for survivors and/or affected families to have, they argued (Front Immunol. 2016 Sep 20;7:357. eCollection 2016).
“There are some indications that the genetic contribution in children with sepsis may be larger than previously assumed,” he said.
The longstanding practice of fluid bolus therapy for resuscitation in pediatric sepsis is being reexamined
The FEAST (Fluid Expansion As Supportive Therapy) study, a randomized trial of more than 3,000 children with severe febrile illness and impaired perfusion in sub-Saharan Africa, turned heads with its finding that fluid boluses significantly increased 48-hour mortality (BMC Med. 2013 Mar 14;11:67).
Indeed, the FEAST findings, supported by mechanistic animal studies, were sufficiently compelling that the use of fluid boluses in both pediatric and adult septic shock is now under scrutiny in two major randomized trials: RIFTS (the Restrictive IV Fluid Trial in Severe Sepsis and Septic Shock), and CLOVERS (Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis). Stay tuned.
Dr. Schlapbach reported having no financial conflicts regarding his presentation.
EXPERT ANALYSIS FROM ESPID 2019
Repeated qSOFA measurements better predict in-hospital mortality from sepsis
Clinical question: Do repeated quick Sepsis-Related Organ Failure Assessment (qSOFA) measurements improve predictive validity for sepsis using in-hospital mortality, compared with a single qSOFA measurement at the time a clinician first suspects infection?
Background: Sepsis in hospitalized patients is associated with poor outcomes, but it is not clear how to best identify patients at risk. For non-ICU patients, the qSOFA score (made up of three simple clinical variables: respiratory rate greater than or equal to 22 breaths/minute, systolic blood pressure less than or equal to 100 mm Hg, and Glasgow Coma Scale score less than 15) has predictive validity for important outcomes including in-hospital mortality. qSOFA is relatively new in clinical practice, and the optimal utilization of the score has not yet been defined.
Study design: Retrospective Cohort Study.
Setting: All adult medical and surgical encounters in the ED, hospital ward, postanesthesia care unit (PACU), and ICU at 12 hospitals in Pennsylvania in 2012.
Synopsis: Kievlan et al. studied whether repeated qSOFA scores improved prediction of in-hospital mortality and allowed identification of specific clinical trajectories. The study included approximately 37,600 encounters. Authors abstracted demographic data, vital signs, laboratory results, and antibiotic/culture orders. An infection cohort was identified by a combination of orders for body fluid culture and antibiotics. The qSOFA scores were gathered at 6-hour intervals from the culture/antibiotic event (suspected sepsis). Scores were low (0), moderate (1), or high (greater than or equal to 2). Mean initial qSOFA scores were greater for patients who died, and remained higher during the 48-hours after suspected infection. Mortality was less than 2% in patients with an initial low qSOFA. 25% of patients with an initial moderate qSOFA had subsequent higher qSOFAs, and they had higher mortality, compared with patients with subsequent low qSOFA scores (16% vs. 4%).
Only those patients with initial qSOFA scores at the time of suspected infection were included, and missing data was common. The results may not be applicable to hospitals with a different sepsis case mix from the those of study institutions.
Bottom line: Repeated qSOFA measurements improve predictive validity for in-hospital mortality for patients with sepsis. Patients with low initial qSOFA scores have a low chance (less than 2%) of in-hospital mortality. Further studies are needed to determine how repeat qSOFA measurements can be used to improve management of patients with sepsis.
Citation: Kievlan DR et al. Evaluation of repeated quick sepsis-related organ failure assessment measurements among patients with suspected infection. Crit Care Med. 2018. doi: 10.1097/CCM.0000000000003360.
Dr. Linker is an assistant professor of medicine in the division of hospital medicine at Mount Sinai Hospital, New York.
Clinical question: Do repeated quick Sepsis-Related Organ Failure Assessment (qSOFA) measurements improve predictive validity for sepsis using in-hospital mortality, compared with a single qSOFA measurement at the time a clinician first suspects infection?
Background: Sepsis in hospitalized patients is associated with poor outcomes, but it is not clear how to best identify patients at risk. For non-ICU patients, the qSOFA score (made up of three simple clinical variables: respiratory rate greater than or equal to 22 breaths/minute, systolic blood pressure less than or equal to 100 mm Hg, and Glasgow Coma Scale score less than 15) has predictive validity for important outcomes including in-hospital mortality. qSOFA is relatively new in clinical practice, and the optimal utilization of the score has not yet been defined.
Study design: Retrospective Cohort Study.
Setting: All adult medical and surgical encounters in the ED, hospital ward, postanesthesia care unit (PACU), and ICU at 12 hospitals in Pennsylvania in 2012.
Synopsis: Kievlan et al. studied whether repeated qSOFA scores improved prediction of in-hospital mortality and allowed identification of specific clinical trajectories. The study included approximately 37,600 encounters. Authors abstracted demographic data, vital signs, laboratory results, and antibiotic/culture orders. An infection cohort was identified by a combination of orders for body fluid culture and antibiotics. The qSOFA scores were gathered at 6-hour intervals from the culture/antibiotic event (suspected sepsis). Scores were low (0), moderate (1), or high (greater than or equal to 2). Mean initial qSOFA scores were greater for patients who died, and remained higher during the 48-hours after suspected infection. Mortality was less than 2% in patients with an initial low qSOFA. 25% of patients with an initial moderate qSOFA had subsequent higher qSOFAs, and they had higher mortality, compared with patients with subsequent low qSOFA scores (16% vs. 4%).
Only those patients with initial qSOFA scores at the time of suspected infection were included, and missing data was common. The results may not be applicable to hospitals with a different sepsis case mix from the those of study institutions.
Bottom line: Repeated qSOFA measurements improve predictive validity for in-hospital mortality for patients with sepsis. Patients with low initial qSOFA scores have a low chance (less than 2%) of in-hospital mortality. Further studies are needed to determine how repeat qSOFA measurements can be used to improve management of patients with sepsis.
Citation: Kievlan DR et al. Evaluation of repeated quick sepsis-related organ failure assessment measurements among patients with suspected infection. Crit Care Med. 2018. doi: 10.1097/CCM.0000000000003360.
Dr. Linker is an assistant professor of medicine in the division of hospital medicine at Mount Sinai Hospital, New York.
Clinical question: Do repeated quick Sepsis-Related Organ Failure Assessment (qSOFA) measurements improve predictive validity for sepsis using in-hospital mortality, compared with a single qSOFA measurement at the time a clinician first suspects infection?
Background: Sepsis in hospitalized patients is associated with poor outcomes, but it is not clear how to best identify patients at risk. For non-ICU patients, the qSOFA score (made up of three simple clinical variables: respiratory rate greater than or equal to 22 breaths/minute, systolic blood pressure less than or equal to 100 mm Hg, and Glasgow Coma Scale score less than 15) has predictive validity for important outcomes including in-hospital mortality. qSOFA is relatively new in clinical practice, and the optimal utilization of the score has not yet been defined.
Study design: Retrospective Cohort Study.
Setting: All adult medical and surgical encounters in the ED, hospital ward, postanesthesia care unit (PACU), and ICU at 12 hospitals in Pennsylvania in 2012.
Synopsis: Kievlan et al. studied whether repeated qSOFA scores improved prediction of in-hospital mortality and allowed identification of specific clinical trajectories. The study included approximately 37,600 encounters. Authors abstracted demographic data, vital signs, laboratory results, and antibiotic/culture orders. An infection cohort was identified by a combination of orders for body fluid culture and antibiotics. The qSOFA scores were gathered at 6-hour intervals from the culture/antibiotic event (suspected sepsis). Scores were low (0), moderate (1), or high (greater than or equal to 2). Mean initial qSOFA scores were greater for patients who died, and remained higher during the 48-hours after suspected infection. Mortality was less than 2% in patients with an initial low qSOFA. 25% of patients with an initial moderate qSOFA had subsequent higher qSOFAs, and they had higher mortality, compared with patients with subsequent low qSOFA scores (16% vs. 4%).
Only those patients with initial qSOFA scores at the time of suspected infection were included, and missing data was common. The results may not be applicable to hospitals with a different sepsis case mix from the those of study institutions.
Bottom line: Repeated qSOFA measurements improve predictive validity for in-hospital mortality for patients with sepsis. Patients with low initial qSOFA scores have a low chance (less than 2%) of in-hospital mortality. Further studies are needed to determine how repeat qSOFA measurements can be used to improve management of patients with sepsis.
Citation: Kievlan DR et al. Evaluation of repeated quick sepsis-related organ failure assessment measurements among patients with suspected infection. Crit Care Med. 2018. doi: 10.1097/CCM.0000000000003360.
Dr. Linker is an assistant professor of medicine in the division of hospital medicine at Mount Sinai Hospital, New York.
Medicare may best Medicare Advantage at reducing readmissions
Although earlier research may suggest otherwise, traditional new research suggests.
Researchers used what they described as “a novel data linkage” comparing 30-day readmission rates after hospitalization for three major conditions in the Hospital Readmissions Reduction Program for patients using traditional Medicare versus Medicare Advantage. Those conditions included acute MI, heart failure, and pneumonia.
“Our results contrast with those of previous studies that have reported lower or statistically similar readmission rates for Medicare Advantage beneficiaries,” Orestis A. Panagiotou, MD, of Brown University, Providence, R.I., and colleagues wrote in a research report published in Annals of Internal Medicine.
In this retrospective cohort study, the researchers linked data from 2011 to 2014 from the Medicare Provider Analysis and Review (MedPAR) file to the Healthcare Effectiveness Data and Information Set (HEDIS).
The novel linkage found that HEDIS data underreported hospital admissions for acute MI, heart failure, and pneumonia, the researchers stated. “Plans incorrectly excluded hospitalizations that should have qualified for the readmission measure, and readmission rates were substantially higher among incorrectly excluded hospitalizations.”
Despite this, in analyses using the linkage of HEDIS and MedPAR, “Medicare Advantage beneficiaries had higher 30-day risk-adjusted readmission rates after [acute MI, heart failure, and pneumonia] than did traditional Medicare beneficiaries,” the investigators noted.
Patients in Medicare Advantage had lower unadjusted readmission rates compared with those in traditional Medicare (16.6% vs. 17.1% for acute MI; 21.4% vs. 21.7% for heart failure; and 16.3% vs. 16.4% for pneumonia). After standardization, Medicare Advantage patients had higher readmission rates, compared with those in traditional Medicare (17.2% vs. 16.9% for acute MI; 21.7% vs. 21.4% for heart failure; and 16.5% vs. 16.0% for pneumonia).
The study authors added that, while unadjusted readmission rates were higher for traditional Medicare beneficiaries, “the direction of the difference reversed after standardization. This occurred because Medicare Advantage beneficiaries have, on average, a lower expected readmission risk [that is, they are ‘healthier’].” Prior studies have documented that Medicare Advantage plans enroll beneficiaries with fewer comorbid conditions and that high-cost beneficiaries switch out of Medicare Advantage and into traditional Medicare.
The researchers suggested four reasons for the differences between the results in this study versus others that compared patients using Medicare with those using Medicare Advantage. These were that the new study included a more comprehensive data set, analyses with comorbid conditions “from a well-validated model applied by CMS [Centers for Medicare & Medicaid Services],” national data focused on three conditions included in the Hospital Readmissions Reduction Program, and patients discharged to places other than skilled nursing facilities and inpatient rehabilitation facilities.
Authors of an accompanying editorial called for caution to be used in interpreting Medicare Advantage enrollment as causing an increased readmission risk.
“[The] results are sensitive to adjustment for case mix,” wrote Peter Huckfeldt, PhD, of the University of Minnesota, Minneapolis, and Neeraj Sood, PhD, of the University of Southern California, Los Angeles, in the editorial published in Annals of Internal Medicine (2019 June 25. doi:10.7326/M19-1599) “Using diagnosis codes on hospital claims for case-mix adjustments may be increasingly perilous. ... To our knowledge, there is no recent evidence comparing the intensity of diagnostic coding between clinically similar [traditional Medicare] and [Medicare Advantage] hospital admissions, but if [traditional Medicare] enrollees were coded more intensively than [Medicare Advantage] enrollees, this could lead to [traditional Medicare] enrollees having lower risk-adjusted readmission rares due to coding practices.”
The editorialists added that using a cross-sectional comparison of Medicare Advantage and traditional Medicare patients is concerning because a “key challenge in estimating the effect of [Medicare Advantage] is that enrollment is voluntary,” which can lead to a number of analytical concerns.
The researchers concluded that their findings “are concerning because CMS uses HEDIS performance to construct composite quality ratings and assign payment bonuses to Medicare Advantage plans.
“Our study suggests a need for improved monitoring of the accuracy of HEDIS data,” they noted.
The National Institute on Aging provided the primary funding for this study. A number of the authors received grants from the National Institutes of Health during the conduct of the study. No other relevant disclosures were reported.
SOURCE: Panagiotou OA et al. Ann Intern Med. 2019 Jun 25. doi: 10.7326/M18-1795.
Although earlier research may suggest otherwise, traditional new research suggests.
Researchers used what they described as “a novel data linkage” comparing 30-day readmission rates after hospitalization for three major conditions in the Hospital Readmissions Reduction Program for patients using traditional Medicare versus Medicare Advantage. Those conditions included acute MI, heart failure, and pneumonia.
“Our results contrast with those of previous studies that have reported lower or statistically similar readmission rates for Medicare Advantage beneficiaries,” Orestis A. Panagiotou, MD, of Brown University, Providence, R.I., and colleagues wrote in a research report published in Annals of Internal Medicine.
In this retrospective cohort study, the researchers linked data from 2011 to 2014 from the Medicare Provider Analysis and Review (MedPAR) file to the Healthcare Effectiveness Data and Information Set (HEDIS).
The novel linkage found that HEDIS data underreported hospital admissions for acute MI, heart failure, and pneumonia, the researchers stated. “Plans incorrectly excluded hospitalizations that should have qualified for the readmission measure, and readmission rates were substantially higher among incorrectly excluded hospitalizations.”
Despite this, in analyses using the linkage of HEDIS and MedPAR, “Medicare Advantage beneficiaries had higher 30-day risk-adjusted readmission rates after [acute MI, heart failure, and pneumonia] than did traditional Medicare beneficiaries,” the investigators noted.
Patients in Medicare Advantage had lower unadjusted readmission rates compared with those in traditional Medicare (16.6% vs. 17.1% for acute MI; 21.4% vs. 21.7% for heart failure; and 16.3% vs. 16.4% for pneumonia). After standardization, Medicare Advantage patients had higher readmission rates, compared with those in traditional Medicare (17.2% vs. 16.9% for acute MI; 21.7% vs. 21.4% for heart failure; and 16.5% vs. 16.0% for pneumonia).
The study authors added that, while unadjusted readmission rates were higher for traditional Medicare beneficiaries, “the direction of the difference reversed after standardization. This occurred because Medicare Advantage beneficiaries have, on average, a lower expected readmission risk [that is, they are ‘healthier’].” Prior studies have documented that Medicare Advantage plans enroll beneficiaries with fewer comorbid conditions and that high-cost beneficiaries switch out of Medicare Advantage and into traditional Medicare.
The researchers suggested four reasons for the differences between the results in this study versus others that compared patients using Medicare with those using Medicare Advantage. These were that the new study included a more comprehensive data set, analyses with comorbid conditions “from a well-validated model applied by CMS [Centers for Medicare & Medicaid Services],” national data focused on three conditions included in the Hospital Readmissions Reduction Program, and patients discharged to places other than skilled nursing facilities and inpatient rehabilitation facilities.
Authors of an accompanying editorial called for caution to be used in interpreting Medicare Advantage enrollment as causing an increased readmission risk.
“[The] results are sensitive to adjustment for case mix,” wrote Peter Huckfeldt, PhD, of the University of Minnesota, Minneapolis, and Neeraj Sood, PhD, of the University of Southern California, Los Angeles, in the editorial published in Annals of Internal Medicine (2019 June 25. doi:10.7326/M19-1599) “Using diagnosis codes on hospital claims for case-mix adjustments may be increasingly perilous. ... To our knowledge, there is no recent evidence comparing the intensity of diagnostic coding between clinically similar [traditional Medicare] and [Medicare Advantage] hospital admissions, but if [traditional Medicare] enrollees were coded more intensively than [Medicare Advantage] enrollees, this could lead to [traditional Medicare] enrollees having lower risk-adjusted readmission rares due to coding practices.”
The editorialists added that using a cross-sectional comparison of Medicare Advantage and traditional Medicare patients is concerning because a “key challenge in estimating the effect of [Medicare Advantage] is that enrollment is voluntary,” which can lead to a number of analytical concerns.
The researchers concluded that their findings “are concerning because CMS uses HEDIS performance to construct composite quality ratings and assign payment bonuses to Medicare Advantage plans.
“Our study suggests a need for improved monitoring of the accuracy of HEDIS data,” they noted.
The National Institute on Aging provided the primary funding for this study. A number of the authors received grants from the National Institutes of Health during the conduct of the study. No other relevant disclosures were reported.
SOURCE: Panagiotou OA et al. Ann Intern Med. 2019 Jun 25. doi: 10.7326/M18-1795.
Although earlier research may suggest otherwise, traditional new research suggests.
Researchers used what they described as “a novel data linkage” comparing 30-day readmission rates after hospitalization for three major conditions in the Hospital Readmissions Reduction Program for patients using traditional Medicare versus Medicare Advantage. Those conditions included acute MI, heart failure, and pneumonia.
“Our results contrast with those of previous studies that have reported lower or statistically similar readmission rates for Medicare Advantage beneficiaries,” Orestis A. Panagiotou, MD, of Brown University, Providence, R.I., and colleagues wrote in a research report published in Annals of Internal Medicine.
In this retrospective cohort study, the researchers linked data from 2011 to 2014 from the Medicare Provider Analysis and Review (MedPAR) file to the Healthcare Effectiveness Data and Information Set (HEDIS).
The novel linkage found that HEDIS data underreported hospital admissions for acute MI, heart failure, and pneumonia, the researchers stated. “Plans incorrectly excluded hospitalizations that should have qualified for the readmission measure, and readmission rates were substantially higher among incorrectly excluded hospitalizations.”
Despite this, in analyses using the linkage of HEDIS and MedPAR, “Medicare Advantage beneficiaries had higher 30-day risk-adjusted readmission rates after [acute MI, heart failure, and pneumonia] than did traditional Medicare beneficiaries,” the investigators noted.
Patients in Medicare Advantage had lower unadjusted readmission rates compared with those in traditional Medicare (16.6% vs. 17.1% for acute MI; 21.4% vs. 21.7% for heart failure; and 16.3% vs. 16.4% for pneumonia). After standardization, Medicare Advantage patients had higher readmission rates, compared with those in traditional Medicare (17.2% vs. 16.9% for acute MI; 21.7% vs. 21.4% for heart failure; and 16.5% vs. 16.0% for pneumonia).
The study authors added that, while unadjusted readmission rates were higher for traditional Medicare beneficiaries, “the direction of the difference reversed after standardization. This occurred because Medicare Advantage beneficiaries have, on average, a lower expected readmission risk [that is, they are ‘healthier’].” Prior studies have documented that Medicare Advantage plans enroll beneficiaries with fewer comorbid conditions and that high-cost beneficiaries switch out of Medicare Advantage and into traditional Medicare.
The researchers suggested four reasons for the differences between the results in this study versus others that compared patients using Medicare with those using Medicare Advantage. These were that the new study included a more comprehensive data set, analyses with comorbid conditions “from a well-validated model applied by CMS [Centers for Medicare & Medicaid Services],” national data focused on three conditions included in the Hospital Readmissions Reduction Program, and patients discharged to places other than skilled nursing facilities and inpatient rehabilitation facilities.
Authors of an accompanying editorial called for caution to be used in interpreting Medicare Advantage enrollment as causing an increased readmission risk.
“[The] results are sensitive to adjustment for case mix,” wrote Peter Huckfeldt, PhD, of the University of Minnesota, Minneapolis, and Neeraj Sood, PhD, of the University of Southern California, Los Angeles, in the editorial published in Annals of Internal Medicine (2019 June 25. doi:10.7326/M19-1599) “Using diagnosis codes on hospital claims for case-mix adjustments may be increasingly perilous. ... To our knowledge, there is no recent evidence comparing the intensity of diagnostic coding between clinically similar [traditional Medicare] and [Medicare Advantage] hospital admissions, but if [traditional Medicare] enrollees were coded more intensively than [Medicare Advantage] enrollees, this could lead to [traditional Medicare] enrollees having lower risk-adjusted readmission rares due to coding practices.”
The editorialists added that using a cross-sectional comparison of Medicare Advantage and traditional Medicare patients is concerning because a “key challenge in estimating the effect of [Medicare Advantage] is that enrollment is voluntary,” which can lead to a number of analytical concerns.
The researchers concluded that their findings “are concerning because CMS uses HEDIS performance to construct composite quality ratings and assign payment bonuses to Medicare Advantage plans.
“Our study suggests a need for improved monitoring of the accuracy of HEDIS data,” they noted.
The National Institute on Aging provided the primary funding for this study. A number of the authors received grants from the National Institutes of Health during the conduct of the study. No other relevant disclosures were reported.
SOURCE: Panagiotou OA et al. Ann Intern Med. 2019 Jun 25. doi: 10.7326/M18-1795.
FROM ANNALS OF INTERNAL MEDICINE