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ACIP approves 2020 adult vaccination schedule
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted unanimously to approve the adult immunization schedule for 2020, although some fine-tuning may occur before publication.
“Some of the wordsmithing may be done later,” ACIP executive secretary Amanda Cohn, MD, said at the ACIP October meeting.
Key updates to the schedule included a change in wording for the definition of the red bars on the table to include “not recommended or contraindicated” instead of only the word “contraindicated.” Committee members were especially interested in changing this wording to guide clinicians in use of the live attenuated influenza vaccine because of its potential value in vaccinating health care personnel.
Other updates include language that vaccination of adolescents and young adults aged 16-23 years who are not at increased risk for meningococcal disease should be vaccinated as follows: “Based on shared clinical decision making, 2-dose series MenB-4C at least 1 month apart or 2-dose series MenB-FHbp at 0, 6 months.”
Similarly, clinical decision-making language was added to the notes for the pneumococcal polysaccharide vaccine (PPSV23) and the 13-valent pneumococcal conjugate vaccine (PCV13).
The routine vaccination calls for only one dose of PPSV23 given on or after the individual’s 65th birthday. Then, based on shared clinical decision making, a dose of PCV13 is recommended for immunocompetent individuals aged 65 years and older. The notes also state that, based on shared clinical decision making, PCV13 and PPSV23 should not be given in the same visit and, if both will be given, PCV13 should be first and should be given 1 year before PPSV23. In addition, “PPSV23 should be given at least 5 years after any previous PPSV23 dose.”
The schedule also adds shared clinical decision making to the notes on human papillomavirus vaccination for adults aged 27-45 years.
The committee members acknowledged the increasing complexity of the adult vaccination schedule, but several members agreed that it is accessible to many clinicians.
“We can’t let the perfect be the enemy of the good” said Jason Goldman, MD, liaison representing the American College of Physicians. “Those who want to learn the schedule will learn it; the health system will learn it,” even if not every specialist does.
The table “is something to draw you in,” said Sandra Fryhofer, MD, an internist who is liaison for the American Medical Association. The notes provide more details.
More specific information about contraindications for patients with cochlear implants, which also came up in the discussion, may be added to the schedule at a later date.
View the current adult vaccination schedule here.
The ACIP members had no financial conflicts to disclose.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted unanimously to approve the adult immunization schedule for 2020, although some fine-tuning may occur before publication.
“Some of the wordsmithing may be done later,” ACIP executive secretary Amanda Cohn, MD, said at the ACIP October meeting.
Key updates to the schedule included a change in wording for the definition of the red bars on the table to include “not recommended or contraindicated” instead of only the word “contraindicated.” Committee members were especially interested in changing this wording to guide clinicians in use of the live attenuated influenza vaccine because of its potential value in vaccinating health care personnel.
Other updates include language that vaccination of adolescents and young adults aged 16-23 years who are not at increased risk for meningococcal disease should be vaccinated as follows: “Based on shared clinical decision making, 2-dose series MenB-4C at least 1 month apart or 2-dose series MenB-FHbp at 0, 6 months.”
Similarly, clinical decision-making language was added to the notes for the pneumococcal polysaccharide vaccine (PPSV23) and the 13-valent pneumococcal conjugate vaccine (PCV13).
The routine vaccination calls for only one dose of PPSV23 given on or after the individual’s 65th birthday. Then, based on shared clinical decision making, a dose of PCV13 is recommended for immunocompetent individuals aged 65 years and older. The notes also state that, based on shared clinical decision making, PCV13 and PPSV23 should not be given in the same visit and, if both will be given, PCV13 should be first and should be given 1 year before PPSV23. In addition, “PPSV23 should be given at least 5 years after any previous PPSV23 dose.”
The schedule also adds shared clinical decision making to the notes on human papillomavirus vaccination for adults aged 27-45 years.
The committee members acknowledged the increasing complexity of the adult vaccination schedule, but several members agreed that it is accessible to many clinicians.
“We can’t let the perfect be the enemy of the good” said Jason Goldman, MD, liaison representing the American College of Physicians. “Those who want to learn the schedule will learn it; the health system will learn it,” even if not every specialist does.
The table “is something to draw you in,” said Sandra Fryhofer, MD, an internist who is liaison for the American Medical Association. The notes provide more details.
More specific information about contraindications for patients with cochlear implants, which also came up in the discussion, may be added to the schedule at a later date.
View the current adult vaccination schedule here.
The ACIP members had no financial conflicts to disclose.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted unanimously to approve the adult immunization schedule for 2020, although some fine-tuning may occur before publication.
“Some of the wordsmithing may be done later,” ACIP executive secretary Amanda Cohn, MD, said at the ACIP October meeting.
Key updates to the schedule included a change in wording for the definition of the red bars on the table to include “not recommended or contraindicated” instead of only the word “contraindicated.” Committee members were especially interested in changing this wording to guide clinicians in use of the live attenuated influenza vaccine because of its potential value in vaccinating health care personnel.
Other updates include language that vaccination of adolescents and young adults aged 16-23 years who are not at increased risk for meningococcal disease should be vaccinated as follows: “Based on shared clinical decision making, 2-dose series MenB-4C at least 1 month apart or 2-dose series MenB-FHbp at 0, 6 months.”
Similarly, clinical decision-making language was added to the notes for the pneumococcal polysaccharide vaccine (PPSV23) and the 13-valent pneumococcal conjugate vaccine (PCV13).
The routine vaccination calls for only one dose of PPSV23 given on or after the individual’s 65th birthday. Then, based on shared clinical decision making, a dose of PCV13 is recommended for immunocompetent individuals aged 65 years and older. The notes also state that, based on shared clinical decision making, PCV13 and PPSV23 should not be given in the same visit and, if both will be given, PCV13 should be first and should be given 1 year before PPSV23. In addition, “PPSV23 should be given at least 5 years after any previous PPSV23 dose.”
The schedule also adds shared clinical decision making to the notes on human papillomavirus vaccination for adults aged 27-45 years.
The committee members acknowledged the increasing complexity of the adult vaccination schedule, but several members agreed that it is accessible to many clinicians.
“We can’t let the perfect be the enemy of the good” said Jason Goldman, MD, liaison representing the American College of Physicians. “Those who want to learn the schedule will learn it; the health system will learn it,” even if not every specialist does.
The table “is something to draw you in,” said Sandra Fryhofer, MD, an internist who is liaison for the American Medical Association. The notes provide more details.
More specific information about contraindications for patients with cochlear implants, which also came up in the discussion, may be added to the schedule at a later date.
View the current adult vaccination schedule here.
The ACIP members had no financial conflicts to disclose.
ACIP plans flu review for older adults
according to data presented at a meeting of the Centers for Disease Control and Prevention’s ACIP.
Lynette Brammer of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD) presented a surveillance update of the flu season in the United States so far. Overall, the influenza A(H3N2) viruses are predominant, although dominance varies in different regions of the country, and it is too soon to predict what strain will dominate later in the season.
“While two of the four vaccine components were updated for the Southern Hemisphere, the components selected for the 2019-2020 Northern Hemisphere vaccine, at this time, look appropriate for the season,” she said.
In other flu news, Lisa Groskopf, MD, of the NCIRD discussed the influenza work group’s plans for a meta-analysis to assess the relative benefit of different vaccines for older adults, in light of the growing variety of products available.
Currently, no preferential recommendations have been made for a specific vaccine for a particular age group. “There’s a dearth of data comparing these vaccines to one another,” said Dr. Groskopf. She added that, because vaccine effectiveness varies by season, the generalizability of effectiveness data is another challenge.
The work group’s systematic review and meta-analysis is designed to compare the high-dose inactivated influenza vaccine (HD-IIV), the adjuvanted inactivated influenza vaccine (aIIV), and the recombinant influenza vaccine (RIV). The study will include adults aged 65 years and older who receive trivalent or quadrivalent HD-IIV, aIIV, or RIV, compared with those who receive another influenza vaccine, a noninfluenza control vaccine, placebo, or no vaccine. The outcomes will include data on safety and effectiveness of the vaccines, Dr. Groskopf said.
In addition to safety and effectiveness, manufacturers such as Sanofi Pasteur continue to collect data on the success of available vaccines and develop new ones. Lee-Jah Chang, MD, of Sanofi Pasteur presented results of a noninferiority study of the company’s investigational high-dose quadrivalent influenza vaccine (QIV-HD; including two prevailing B viruses) versus the high-dose trivalent influenza vaccine (TID-HD). The study was conducted at 35 sites in the United States and included 2,670 adults aged 65 years and older.
Overall, the reactogenicity profile for patients given QIV-HD was similar to that of TID-HD, and approximately 5% of patients in the QIV group reported an immediate adverse event, Dr. Chang said. However, no related deaths or related adverse events of special interest occurred in any of the study groups.
Sanofi plans to pursue licensure of the QIV-HD vaccine, with a Center for Biologics Evaluation and Research action date of Nov. 4, 2019, said Dr. Chang. If the vaccine is licensed, it should be available for purchase by health care providers in the first quarter of 2020.
The ACIP members had no financial conflicts to disclose.
according to data presented at a meeting of the Centers for Disease Control and Prevention’s ACIP.
Lynette Brammer of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD) presented a surveillance update of the flu season in the United States so far. Overall, the influenza A(H3N2) viruses are predominant, although dominance varies in different regions of the country, and it is too soon to predict what strain will dominate later in the season.
“While two of the four vaccine components were updated for the Southern Hemisphere, the components selected for the 2019-2020 Northern Hemisphere vaccine, at this time, look appropriate for the season,” she said.
In other flu news, Lisa Groskopf, MD, of the NCIRD discussed the influenza work group’s plans for a meta-analysis to assess the relative benefit of different vaccines for older adults, in light of the growing variety of products available.
Currently, no preferential recommendations have been made for a specific vaccine for a particular age group. “There’s a dearth of data comparing these vaccines to one another,” said Dr. Groskopf. She added that, because vaccine effectiveness varies by season, the generalizability of effectiveness data is another challenge.
The work group’s systematic review and meta-analysis is designed to compare the high-dose inactivated influenza vaccine (HD-IIV), the adjuvanted inactivated influenza vaccine (aIIV), and the recombinant influenza vaccine (RIV). The study will include adults aged 65 years and older who receive trivalent or quadrivalent HD-IIV, aIIV, or RIV, compared with those who receive another influenza vaccine, a noninfluenza control vaccine, placebo, or no vaccine. The outcomes will include data on safety and effectiveness of the vaccines, Dr. Groskopf said.
In addition to safety and effectiveness, manufacturers such as Sanofi Pasteur continue to collect data on the success of available vaccines and develop new ones. Lee-Jah Chang, MD, of Sanofi Pasteur presented results of a noninferiority study of the company’s investigational high-dose quadrivalent influenza vaccine (QIV-HD; including two prevailing B viruses) versus the high-dose trivalent influenza vaccine (TID-HD). The study was conducted at 35 sites in the United States and included 2,670 adults aged 65 years and older.
Overall, the reactogenicity profile for patients given QIV-HD was similar to that of TID-HD, and approximately 5% of patients in the QIV group reported an immediate adverse event, Dr. Chang said. However, no related deaths or related adverse events of special interest occurred in any of the study groups.
Sanofi plans to pursue licensure of the QIV-HD vaccine, with a Center for Biologics Evaluation and Research action date of Nov. 4, 2019, said Dr. Chang. If the vaccine is licensed, it should be available for purchase by health care providers in the first quarter of 2020.
The ACIP members had no financial conflicts to disclose.
according to data presented at a meeting of the Centers for Disease Control and Prevention’s ACIP.
Lynette Brammer of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD) presented a surveillance update of the flu season in the United States so far. Overall, the influenza A(H3N2) viruses are predominant, although dominance varies in different regions of the country, and it is too soon to predict what strain will dominate later in the season.
“While two of the four vaccine components were updated for the Southern Hemisphere, the components selected for the 2019-2020 Northern Hemisphere vaccine, at this time, look appropriate for the season,” she said.
In other flu news, Lisa Groskopf, MD, of the NCIRD discussed the influenza work group’s plans for a meta-analysis to assess the relative benefit of different vaccines for older adults, in light of the growing variety of products available.
Currently, no preferential recommendations have been made for a specific vaccine for a particular age group. “There’s a dearth of data comparing these vaccines to one another,” said Dr. Groskopf. She added that, because vaccine effectiveness varies by season, the generalizability of effectiveness data is another challenge.
The work group’s systematic review and meta-analysis is designed to compare the high-dose inactivated influenza vaccine (HD-IIV), the adjuvanted inactivated influenza vaccine (aIIV), and the recombinant influenza vaccine (RIV). The study will include adults aged 65 years and older who receive trivalent or quadrivalent HD-IIV, aIIV, or RIV, compared with those who receive another influenza vaccine, a noninfluenza control vaccine, placebo, or no vaccine. The outcomes will include data on safety and effectiveness of the vaccines, Dr. Groskopf said.
In addition to safety and effectiveness, manufacturers such as Sanofi Pasteur continue to collect data on the success of available vaccines and develop new ones. Lee-Jah Chang, MD, of Sanofi Pasteur presented results of a noninferiority study of the company’s investigational high-dose quadrivalent influenza vaccine (QIV-HD; including two prevailing B viruses) versus the high-dose trivalent influenza vaccine (TID-HD). The study was conducted at 35 sites in the United States and included 2,670 adults aged 65 years and older.
Overall, the reactogenicity profile for patients given QIV-HD was similar to that of TID-HD, and approximately 5% of patients in the QIV group reported an immediate adverse event, Dr. Chang said. However, no related deaths or related adverse events of special interest occurred in any of the study groups.
Sanofi plans to pursue licensure of the QIV-HD vaccine, with a Center for Biologics Evaluation and Research action date of Nov. 4, 2019, said Dr. Chang. If the vaccine is licensed, it should be available for purchase by health care providers in the first quarter of 2020.
The ACIP members had no financial conflicts to disclose.
REPORTING FROM AN ACIP MEETING
ACIP recommends two options for pertussis vaccination
Either the Tdap or Td vaccine is an acceptable option for pertussis vaccination in most situations, recommended the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
In a unanimous 14-0 vote at the October meeting, based on the immunization schedule for persons aged 7 years and older.
Safety data showed no differences in safety concerns between Tdap and Td, including data from pregnant women, said Fiona Havers, MD, of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), Atlanta.
Several of the ACIP members noted that the revised language to include both Tdap and Td reflects the increased use of Tdap and allows for maximum flexibility in clinical settings.
The revised language advises that booster doses of “either Td or Tdap” every 10 years throughout life are recommended for continued protection against tetanus and diphtheria. In addition, either Td or Tdap should be used if a tetanus toxoid–containing vaccine is indicated for prophylaxis in nonpregnant individuals.
For catch-up recommendations, which also apply to pregnant women, the committee approved the following wording for a series of three doses for individuals aged 7-18 years and 19 years and older who have never been vaccinated, that “the preferred schedule is a dose of Tdap (preferably the first dose), followed by either Tdap or Td at least 4 weeks afterward and another dose of either Td or Tdap 6-12 months later.” Individuals in these same age groups who are not fully vaccinated should receive one dose of Tdap, and a dose of either Td or Tdap if additional doses are needed.
The committee also voted unanimously 14-0 to accept the updated wording for pertussis vaccination in the Vaccines for Children program.
The ACIP members had no financial conflicts to disclose.
Either the Tdap or Td vaccine is an acceptable option for pertussis vaccination in most situations, recommended the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
In a unanimous 14-0 vote at the October meeting, based on the immunization schedule for persons aged 7 years and older.
Safety data showed no differences in safety concerns between Tdap and Td, including data from pregnant women, said Fiona Havers, MD, of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), Atlanta.
Several of the ACIP members noted that the revised language to include both Tdap and Td reflects the increased use of Tdap and allows for maximum flexibility in clinical settings.
The revised language advises that booster doses of “either Td or Tdap” every 10 years throughout life are recommended for continued protection against tetanus and diphtheria. In addition, either Td or Tdap should be used if a tetanus toxoid–containing vaccine is indicated for prophylaxis in nonpregnant individuals.
For catch-up recommendations, which also apply to pregnant women, the committee approved the following wording for a series of three doses for individuals aged 7-18 years and 19 years and older who have never been vaccinated, that “the preferred schedule is a dose of Tdap (preferably the first dose), followed by either Tdap or Td at least 4 weeks afterward and another dose of either Td or Tdap 6-12 months later.” Individuals in these same age groups who are not fully vaccinated should receive one dose of Tdap, and a dose of either Td or Tdap if additional doses are needed.
The committee also voted unanimously 14-0 to accept the updated wording for pertussis vaccination in the Vaccines for Children program.
The ACIP members had no financial conflicts to disclose.
Either the Tdap or Td vaccine is an acceptable option for pertussis vaccination in most situations, recommended the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
In a unanimous 14-0 vote at the October meeting, based on the immunization schedule for persons aged 7 years and older.
Safety data showed no differences in safety concerns between Tdap and Td, including data from pregnant women, said Fiona Havers, MD, of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), Atlanta.
Several of the ACIP members noted that the revised language to include both Tdap and Td reflects the increased use of Tdap and allows for maximum flexibility in clinical settings.
The revised language advises that booster doses of “either Td or Tdap” every 10 years throughout life are recommended for continued protection against tetanus and diphtheria. In addition, either Td or Tdap should be used if a tetanus toxoid–containing vaccine is indicated for prophylaxis in nonpregnant individuals.
For catch-up recommendations, which also apply to pregnant women, the committee approved the following wording for a series of three doses for individuals aged 7-18 years and 19 years and older who have never been vaccinated, that “the preferred schedule is a dose of Tdap (preferably the first dose), followed by either Tdap or Td at least 4 weeks afterward and another dose of either Td or Tdap 6-12 months later.” Individuals in these same age groups who are not fully vaccinated should receive one dose of Tdap, and a dose of either Td or Tdap if additional doses are needed.
The committee also voted unanimously 14-0 to accept the updated wording for pertussis vaccination in the Vaccines for Children program.
The ACIP members had no financial conflicts to disclose.
FROM AN ACIP MEETING
Couples-based cognitive-behavioral therapy curbs postpartum depression
Postpartum women who participated in a couples-based cognitive-behavioral therapy program showed less postpartum depression than did women in a solo program, according to data from 388 couples.
Previous studies have shown that both men and women experience depression up to 1 year after the birth of a child, but “no studies have compared the relative effectiveness of couple-based and women-alone interventions on parental mental health,” wrote F-W Ngai of the Hong Kong Polytechnic University and colleagues.
In a study published in the BJOG: An International Journal of Obstetrics and Gynaecology, the researchers randomized 134 childbearing Chinese couples to a couples-based cognitive-behavioral intervention (CBI), 124 women to a women-only CBI, and 130 controls who did not receive CBI. The CBI consisted of one 3-hour antenatal group session and two 30-mintue postnatal telephone sessions. Depressive symptoms were assessed during pregnancy as a baseline, and at 6 weeks, 6 months, and 12 months post partum and measured using the Edinburgh Postnatal Depression Scale (EPDS). Demographic characteristics were similar among the groups.
Overall, mothers in the couples-based CBI group showed significant improvement in depressive symptoms at 6 weeks post partum, compared with women in the women-only group or the controls (average differences in scores on the EPDS of 1.46 and 1.71, respectively). In addition, the percentage of women who met criteria for postnatal depression with an EPDS score of at least 10 was significantly lower (17.8% difference) in the couples-based CBI group compared with controls at 6 weeks postpartum. However, the differences between the groups were no longer significant at 6 months and 12 months post partum, and no differences in depression scores were seen among fathers at any time point.
“The findings provide evidence for the effectiveness of the couple-based cognitive behavioral intervention in improving postnatal depression among mothers, but not fathers,” and additional research is needed to find interventions that protect new fathers from depression, the researchers said.
The study findings were limited by several factors including the use only of self-reports for postpartum assessment and the homogeneous nature of the study population (all were educated, first-time Chinese parents), the researchers noted. However, the results support those from previous studies and suggest that couples-based CBI is feasible for use in primary care to promote perinatal health, they concluded.
The researchers had no financial conflicts to disclose.
SOURCE: Ngai F-W et al. BJOG. 2019. doi: 10.1111/1471-0528.15862.
Postpartum women who participated in a couples-based cognitive-behavioral therapy program showed less postpartum depression than did women in a solo program, according to data from 388 couples.
Previous studies have shown that both men and women experience depression up to 1 year after the birth of a child, but “no studies have compared the relative effectiveness of couple-based and women-alone interventions on parental mental health,” wrote F-W Ngai of the Hong Kong Polytechnic University and colleagues.
In a study published in the BJOG: An International Journal of Obstetrics and Gynaecology, the researchers randomized 134 childbearing Chinese couples to a couples-based cognitive-behavioral intervention (CBI), 124 women to a women-only CBI, and 130 controls who did not receive CBI. The CBI consisted of one 3-hour antenatal group session and two 30-mintue postnatal telephone sessions. Depressive symptoms were assessed during pregnancy as a baseline, and at 6 weeks, 6 months, and 12 months post partum and measured using the Edinburgh Postnatal Depression Scale (EPDS). Demographic characteristics were similar among the groups.
Overall, mothers in the couples-based CBI group showed significant improvement in depressive symptoms at 6 weeks post partum, compared with women in the women-only group or the controls (average differences in scores on the EPDS of 1.46 and 1.71, respectively). In addition, the percentage of women who met criteria for postnatal depression with an EPDS score of at least 10 was significantly lower (17.8% difference) in the couples-based CBI group compared with controls at 6 weeks postpartum. However, the differences between the groups were no longer significant at 6 months and 12 months post partum, and no differences in depression scores were seen among fathers at any time point.
“The findings provide evidence for the effectiveness of the couple-based cognitive behavioral intervention in improving postnatal depression among mothers, but not fathers,” and additional research is needed to find interventions that protect new fathers from depression, the researchers said.
The study findings were limited by several factors including the use only of self-reports for postpartum assessment and the homogeneous nature of the study population (all were educated, first-time Chinese parents), the researchers noted. However, the results support those from previous studies and suggest that couples-based CBI is feasible for use in primary care to promote perinatal health, they concluded.
The researchers had no financial conflicts to disclose.
SOURCE: Ngai F-W et al. BJOG. 2019. doi: 10.1111/1471-0528.15862.
Postpartum women who participated in a couples-based cognitive-behavioral therapy program showed less postpartum depression than did women in a solo program, according to data from 388 couples.
Previous studies have shown that both men and women experience depression up to 1 year after the birth of a child, but “no studies have compared the relative effectiveness of couple-based and women-alone interventions on parental mental health,” wrote F-W Ngai of the Hong Kong Polytechnic University and colleagues.
In a study published in the BJOG: An International Journal of Obstetrics and Gynaecology, the researchers randomized 134 childbearing Chinese couples to a couples-based cognitive-behavioral intervention (CBI), 124 women to a women-only CBI, and 130 controls who did not receive CBI. The CBI consisted of one 3-hour antenatal group session and two 30-mintue postnatal telephone sessions. Depressive symptoms were assessed during pregnancy as a baseline, and at 6 weeks, 6 months, and 12 months post partum and measured using the Edinburgh Postnatal Depression Scale (EPDS). Demographic characteristics were similar among the groups.
Overall, mothers in the couples-based CBI group showed significant improvement in depressive symptoms at 6 weeks post partum, compared with women in the women-only group or the controls (average differences in scores on the EPDS of 1.46 and 1.71, respectively). In addition, the percentage of women who met criteria for postnatal depression with an EPDS score of at least 10 was significantly lower (17.8% difference) in the couples-based CBI group compared with controls at 6 weeks postpartum. However, the differences between the groups were no longer significant at 6 months and 12 months post partum, and no differences in depression scores were seen among fathers at any time point.
“The findings provide evidence for the effectiveness of the couple-based cognitive behavioral intervention in improving postnatal depression among mothers, but not fathers,” and additional research is needed to find interventions that protect new fathers from depression, the researchers said.
The study findings were limited by several factors including the use only of self-reports for postpartum assessment and the homogeneous nature of the study population (all were educated, first-time Chinese parents), the researchers noted. However, the results support those from previous studies and suggest that couples-based CBI is feasible for use in primary care to promote perinatal health, they concluded.
The researchers had no financial conflicts to disclose.
SOURCE: Ngai F-W et al. BJOG. 2019. doi: 10.1111/1471-0528.15862.
FROM THE BJOG: AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY
Eating disorders may add to poor type 2 control, but BMI confounds the issue
Type 2 diabetes patients with binge-eating psychopathology had worse glycemic control than did type 2 diabetes patients without eating disorders, but weight may be a modifying factor, according to a study of 70 outpatients with type 2 diabetes.
“Although the comorbidity of an ED [eating disorder] and T2DM [type 2 diabetes mellitus] has been observed across studies, the impact of this association on the clinical control of diabetes has been less consistent,” wrote Marcello Papelbaum, MD, of the State Institute of Diabetes and Endocrinology, Rio de Janeiro and colleagues.
In an exploratory study published in the Journal of Eating Disorders, the researchers assessed consecutive diabetes patients at a single center. The patients were aged 18-65 years, 77% were women, and 50% were obese. Glycemic control of diabetes was assessed measuring the levels of fasting blood glucose (FBG) and hemoglobin A1c. A total of 14 patients had an eating disorder, and 7 of them had binge eating disorder (BED). The BED patients were combined with three bulimic patients and four patients with subclinical BED and classified as binge-eating related ED.
Although FBG and HbA1c were significantly worse in patients with an eating disorder, compared with patients with normal eating patterns, the significance disappeared when body mass index (BMI) was added to the regression model. “Specifically, normal-BMI individuals exhibited a rate of ED of 8%, contrasted with a 26% prevalence of ED in obese patients,” the authors stated.
The findings were limited by the exploratory study design, small sample size, and lack of controlling for multiple variables, the researchers noted.
However, “although the objective negative clinical impact of an ED on type 2 diabetes control is yet to be confirmed, is possible to speculate that the remission of binge episodes could play a major role in diabetes treatment,” they said.
The researchers had no financial conflicts to disclose.
SOURCE: Papelbaum M et al. J Eat Disord. 2019 Sep 6. doi: 10.1186/s40337-019-0260-4.
Type 2 diabetes patients with binge-eating psychopathology had worse glycemic control than did type 2 diabetes patients without eating disorders, but weight may be a modifying factor, according to a study of 70 outpatients with type 2 diabetes.
“Although the comorbidity of an ED [eating disorder] and T2DM [type 2 diabetes mellitus] has been observed across studies, the impact of this association on the clinical control of diabetes has been less consistent,” wrote Marcello Papelbaum, MD, of the State Institute of Diabetes and Endocrinology, Rio de Janeiro and colleagues.
In an exploratory study published in the Journal of Eating Disorders, the researchers assessed consecutive diabetes patients at a single center. The patients were aged 18-65 years, 77% were women, and 50% were obese. Glycemic control of diabetes was assessed measuring the levels of fasting blood glucose (FBG) and hemoglobin A1c. A total of 14 patients had an eating disorder, and 7 of them had binge eating disorder (BED). The BED patients were combined with three bulimic patients and four patients with subclinical BED and classified as binge-eating related ED.
Although FBG and HbA1c were significantly worse in patients with an eating disorder, compared with patients with normal eating patterns, the significance disappeared when body mass index (BMI) was added to the regression model. “Specifically, normal-BMI individuals exhibited a rate of ED of 8%, contrasted with a 26% prevalence of ED in obese patients,” the authors stated.
The findings were limited by the exploratory study design, small sample size, and lack of controlling for multiple variables, the researchers noted.
However, “although the objective negative clinical impact of an ED on type 2 diabetes control is yet to be confirmed, is possible to speculate that the remission of binge episodes could play a major role in diabetes treatment,” they said.
The researchers had no financial conflicts to disclose.
SOURCE: Papelbaum M et al. J Eat Disord. 2019 Sep 6. doi: 10.1186/s40337-019-0260-4.
Type 2 diabetes patients with binge-eating psychopathology had worse glycemic control than did type 2 diabetes patients without eating disorders, but weight may be a modifying factor, according to a study of 70 outpatients with type 2 diabetes.
“Although the comorbidity of an ED [eating disorder] and T2DM [type 2 diabetes mellitus] has been observed across studies, the impact of this association on the clinical control of diabetes has been less consistent,” wrote Marcello Papelbaum, MD, of the State Institute of Diabetes and Endocrinology, Rio de Janeiro and colleagues.
In an exploratory study published in the Journal of Eating Disorders, the researchers assessed consecutive diabetes patients at a single center. The patients were aged 18-65 years, 77% were women, and 50% were obese. Glycemic control of diabetes was assessed measuring the levels of fasting blood glucose (FBG) and hemoglobin A1c. A total of 14 patients had an eating disorder, and 7 of them had binge eating disorder (BED). The BED patients were combined with three bulimic patients and four patients with subclinical BED and classified as binge-eating related ED.
Although FBG and HbA1c were significantly worse in patients with an eating disorder, compared with patients with normal eating patterns, the significance disappeared when body mass index (BMI) was added to the regression model. “Specifically, normal-BMI individuals exhibited a rate of ED of 8%, contrasted with a 26% prevalence of ED in obese patients,” the authors stated.
The findings were limited by the exploratory study design, small sample size, and lack of controlling for multiple variables, the researchers noted.
However, “although the objective negative clinical impact of an ED on type 2 diabetes control is yet to be confirmed, is possible to speculate that the remission of binge episodes could play a major role in diabetes treatment,” they said.
The researchers had no financial conflicts to disclose.
SOURCE: Papelbaum M et al. J Eat Disord. 2019 Sep 6. doi: 10.1186/s40337-019-0260-4.
FROM THE JOURNAL OF EATING DISORDERS
Yale-Brown Obsessive Scale shows value for assessing binge eating patients
Symptoms of binge eating disorder can be assessed with a modified version of the Yale-Brown Obsessive Compulsive Scale, based on data from an analysis of three phase III studies.
The Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) is designed to assess symptoms of binge eating disorder (BED), including binge eating thoughts and compulsiveness. “Psychometric testing and analysis of the Y-BOCS-BE is being conducted as a multistage process to optimize the characterization of BED,” wrote Karen Yee, PhD, of Shire (now part of Takeda), Boston, and colleagues.
In a study published in Quality of Life Research, investigators examined the validity of the Y-BOCS-BE in terms of dimensionality, internal consistency, convergent validity, test-retest reliability, and determination of clinically meaningful improvement. The Y-BOCS-BE is a 10-item clinician-rated scale with total scores from 0 to 4 on which 0 equals no symptoms and 4 equals extreme symptoms.
Overall, the Y-BOCS-BE’s internal consistency and convergent validity were maximized at 12 weeks, and test-retest reliability was maximized in an 8-week retest interval, minimal clinically important improvement could not be assessed in the two short-term efficacy studies, but “estimates in score reductions of 12-17 points were taken to represent the best estimates of clinically meaningful improvement,” the researchers said.
The findings were limited by several factors including the use of a study population of BED patients without psychiatric comorbidities, and the inclusion only of those who did not relapse the researchers noted. However, the results “set the stage for normalizing the Y-BOCS-BE and increasing the understanding of the clinical significance of Y-BOCS-BE scores and score changes to be useful both for clinical practice and clinical research,” they said.
Dr. Yee disclosed being employed by Shire and owning stock in Takeda. The studies were funded by Shire.
SOURCE: Yee K et al. Qual Life Res. 2019 Aug 31. doi: 10.1007/s11136-019-02277-8 .
Symptoms of binge eating disorder can be assessed with a modified version of the Yale-Brown Obsessive Compulsive Scale, based on data from an analysis of three phase III studies.
The Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) is designed to assess symptoms of binge eating disorder (BED), including binge eating thoughts and compulsiveness. “Psychometric testing and analysis of the Y-BOCS-BE is being conducted as a multistage process to optimize the characterization of BED,” wrote Karen Yee, PhD, of Shire (now part of Takeda), Boston, and colleagues.
In a study published in Quality of Life Research, investigators examined the validity of the Y-BOCS-BE in terms of dimensionality, internal consistency, convergent validity, test-retest reliability, and determination of clinically meaningful improvement. The Y-BOCS-BE is a 10-item clinician-rated scale with total scores from 0 to 4 on which 0 equals no symptoms and 4 equals extreme symptoms.
Overall, the Y-BOCS-BE’s internal consistency and convergent validity were maximized at 12 weeks, and test-retest reliability was maximized in an 8-week retest interval, minimal clinically important improvement could not be assessed in the two short-term efficacy studies, but “estimates in score reductions of 12-17 points were taken to represent the best estimates of clinically meaningful improvement,” the researchers said.
The findings were limited by several factors including the use of a study population of BED patients without psychiatric comorbidities, and the inclusion only of those who did not relapse the researchers noted. However, the results “set the stage for normalizing the Y-BOCS-BE and increasing the understanding of the clinical significance of Y-BOCS-BE scores and score changes to be useful both for clinical practice and clinical research,” they said.
Dr. Yee disclosed being employed by Shire and owning stock in Takeda. The studies were funded by Shire.
SOURCE: Yee K et al. Qual Life Res. 2019 Aug 31. doi: 10.1007/s11136-019-02277-8 .
Symptoms of binge eating disorder can be assessed with a modified version of the Yale-Brown Obsessive Compulsive Scale, based on data from an analysis of three phase III studies.
The Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) is designed to assess symptoms of binge eating disorder (BED), including binge eating thoughts and compulsiveness. “Psychometric testing and analysis of the Y-BOCS-BE is being conducted as a multistage process to optimize the characterization of BED,” wrote Karen Yee, PhD, of Shire (now part of Takeda), Boston, and colleagues.
In a study published in Quality of Life Research, investigators examined the validity of the Y-BOCS-BE in terms of dimensionality, internal consistency, convergent validity, test-retest reliability, and determination of clinically meaningful improvement. The Y-BOCS-BE is a 10-item clinician-rated scale with total scores from 0 to 4 on which 0 equals no symptoms and 4 equals extreme symptoms.
Overall, the Y-BOCS-BE’s internal consistency and convergent validity were maximized at 12 weeks, and test-retest reliability was maximized in an 8-week retest interval, minimal clinically important improvement could not be assessed in the two short-term efficacy studies, but “estimates in score reductions of 12-17 points were taken to represent the best estimates of clinically meaningful improvement,” the researchers said.
The findings were limited by several factors including the use of a study population of BED patients without psychiatric comorbidities, and the inclusion only of those who did not relapse the researchers noted. However, the results “set the stage for normalizing the Y-BOCS-BE and increasing the understanding of the clinical significance of Y-BOCS-BE scores and score changes to be useful both for clinical practice and clinical research,” they said.
Dr. Yee disclosed being employed by Shire and owning stock in Takeda. The studies were funded by Shire.
SOURCE: Yee K et al. Qual Life Res. 2019 Aug 31. doi: 10.1007/s11136-019-02277-8 .
FROM QUALITY OF LIFE RESEARCH
Study: Half of college women exhibited binge eating symptoms
Approximately half of college-aged women exhibit binge eating symptoms, and these women scored significantly higher on measures of depression, stress, and anxiety than do non–binge eaters, based on data from 154 women at a Palestine Polytechnic University in Hebron.
Previous studies show that binge eating disorder is multifactorial and associated with depression and anxiety, however, “To our knowledge, no study has yet assessed the prevalence of binge eating symptoms among female university students,” wrote Manal M. Badrasawi, PhD, of An-Najah National University, Tulkarm, Palestine, and colleagues.
In a cross-sectional study published in the Journal of Eating Disorders, the researchers interviewed 154 female college students in Palestine using the using BEDS-7 (Binge Eating Disorder Screener-7). The average age of the participants was 20 years.
Overall, 50% of the students showed positive binge eating symptoms, and these individuals had significantly higher scores on measures of depression, stress, and anxiety compared to individuals without binge eating symptoms.
Binge eating also was significantly associated with greater frequency of eating between meals and increased snacking, but no significant association was noted between binge eating and sociodemographic variables, including place of residence, marital status, and years of study. Binge eating was not significantly associated with weight status.
The researchers had no financial conflicts to disclose.
SOURCE: Badrasawi MM et al. J Eat Disord. 2019 Oct 2;7:33. doi: 10.1186/s40337-019-0263-1.2019.
Approximately half of college-aged women exhibit binge eating symptoms, and these women scored significantly higher on measures of depression, stress, and anxiety than do non–binge eaters, based on data from 154 women at a Palestine Polytechnic University in Hebron.
Previous studies show that binge eating disorder is multifactorial and associated with depression and anxiety, however, “To our knowledge, no study has yet assessed the prevalence of binge eating symptoms among female university students,” wrote Manal M. Badrasawi, PhD, of An-Najah National University, Tulkarm, Palestine, and colleagues.
In a cross-sectional study published in the Journal of Eating Disorders, the researchers interviewed 154 female college students in Palestine using the using BEDS-7 (Binge Eating Disorder Screener-7). The average age of the participants was 20 years.
Overall, 50% of the students showed positive binge eating symptoms, and these individuals had significantly higher scores on measures of depression, stress, and anxiety compared to individuals without binge eating symptoms.
Binge eating also was significantly associated with greater frequency of eating between meals and increased snacking, but no significant association was noted between binge eating and sociodemographic variables, including place of residence, marital status, and years of study. Binge eating was not significantly associated with weight status.
The researchers had no financial conflicts to disclose.
SOURCE: Badrasawi MM et al. J Eat Disord. 2019 Oct 2;7:33. doi: 10.1186/s40337-019-0263-1.2019.
Approximately half of college-aged women exhibit binge eating symptoms, and these women scored significantly higher on measures of depression, stress, and anxiety than do non–binge eaters, based on data from 154 women at a Palestine Polytechnic University in Hebron.
Previous studies show that binge eating disorder is multifactorial and associated with depression and anxiety, however, “To our knowledge, no study has yet assessed the prevalence of binge eating symptoms among female university students,” wrote Manal M. Badrasawi, PhD, of An-Najah National University, Tulkarm, Palestine, and colleagues.
In a cross-sectional study published in the Journal of Eating Disorders, the researchers interviewed 154 female college students in Palestine using the using BEDS-7 (Binge Eating Disorder Screener-7). The average age of the participants was 20 years.
Overall, 50% of the students showed positive binge eating symptoms, and these individuals had significantly higher scores on measures of depression, stress, and anxiety compared to individuals without binge eating symptoms.
Binge eating also was significantly associated with greater frequency of eating between meals and increased snacking, but no significant association was noted between binge eating and sociodemographic variables, including place of residence, marital status, and years of study. Binge eating was not significantly associated with weight status.
The researchers had no financial conflicts to disclose.
SOURCE: Badrasawi MM et al. J Eat Disord. 2019 Oct 2;7:33. doi: 10.1186/s40337-019-0263-1.2019.
FROM THE JOURNAL OF EATING DISORDERS
Prior maternal gastric bypass surgery tied to fewer birth defects
according to data from a cohort study of 2,921 women with a history of gastric bypass surgery and 30,573 matched controls.
“Obesity is associated with poor glucose control, which is teratogenic. Bariatric surgery results in weight loss and glucose normalization but is also associated with nutritional deficiencies and substance abuse, which could cause birth defects as hypothesized based on case series,” wrote Martin Neovius, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.
To determine the risk of birth defects for infants born to women after gastric bypass surgery, the researchers used the Swedish Medical Birth Register to identify singleton infants born between 2007 and 2014 to women who underwent Roux-en-Y gastric bypass surgery and matched controls. The findings were published in a research letter in JAMA.
In the surgery group, the mean interval from surgery to conception was 1.6 years, and the mean weight loss was 40 kg for these women. In addition, the use of diabetes drugs decreased from 10% before surgery to 2% during the 6 months before conception.
Overall, major birth defects occurred in 3% of infants in the gastric bypass groups versus 5% of infants in the control group (risk ratio, 0.67). No neural tube defects occurred in the surgery group and 20 cases of neural tube defects were noted in the control group.
The study was limited by several factors including the lack of data on pregnancy termination, exclusion of stillbirths, and inability to analyze individual birth defects because of small numbers, the researchers noted.
Nonetheless, the results suggest that “a mechanism could be that surgery-induced improvements in glucose metabolism, and potentially other beneficial physiologic changes, led to a reduction of major birth defect risk to a level similar to that of the general population,” they said.
Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.
SOURCE: Neovius M et al. JAMA. 2019 Oct 15; 322:1515-17.
according to data from a cohort study of 2,921 women with a history of gastric bypass surgery and 30,573 matched controls.
“Obesity is associated with poor glucose control, which is teratogenic. Bariatric surgery results in weight loss and glucose normalization but is also associated with nutritional deficiencies and substance abuse, which could cause birth defects as hypothesized based on case series,” wrote Martin Neovius, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.
To determine the risk of birth defects for infants born to women after gastric bypass surgery, the researchers used the Swedish Medical Birth Register to identify singleton infants born between 2007 and 2014 to women who underwent Roux-en-Y gastric bypass surgery and matched controls. The findings were published in a research letter in JAMA.
In the surgery group, the mean interval from surgery to conception was 1.6 years, and the mean weight loss was 40 kg for these women. In addition, the use of diabetes drugs decreased from 10% before surgery to 2% during the 6 months before conception.
Overall, major birth defects occurred in 3% of infants in the gastric bypass groups versus 5% of infants in the control group (risk ratio, 0.67). No neural tube defects occurred in the surgery group and 20 cases of neural tube defects were noted in the control group.
The study was limited by several factors including the lack of data on pregnancy termination, exclusion of stillbirths, and inability to analyze individual birth defects because of small numbers, the researchers noted.
Nonetheless, the results suggest that “a mechanism could be that surgery-induced improvements in glucose metabolism, and potentially other beneficial physiologic changes, led to a reduction of major birth defect risk to a level similar to that of the general population,” they said.
Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.
SOURCE: Neovius M et al. JAMA. 2019 Oct 15; 322:1515-17.
according to data from a cohort study of 2,921 women with a history of gastric bypass surgery and 30,573 matched controls.
“Obesity is associated with poor glucose control, which is teratogenic. Bariatric surgery results in weight loss and glucose normalization but is also associated with nutritional deficiencies and substance abuse, which could cause birth defects as hypothesized based on case series,” wrote Martin Neovius, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.
To determine the risk of birth defects for infants born to women after gastric bypass surgery, the researchers used the Swedish Medical Birth Register to identify singleton infants born between 2007 and 2014 to women who underwent Roux-en-Y gastric bypass surgery and matched controls. The findings were published in a research letter in JAMA.
In the surgery group, the mean interval from surgery to conception was 1.6 years, and the mean weight loss was 40 kg for these women. In addition, the use of diabetes drugs decreased from 10% before surgery to 2% during the 6 months before conception.
Overall, major birth defects occurred in 3% of infants in the gastric bypass groups versus 5% of infants in the control group (risk ratio, 0.67). No neural tube defects occurred in the surgery group and 20 cases of neural tube defects were noted in the control group.
The study was limited by several factors including the lack of data on pregnancy termination, exclusion of stillbirths, and inability to analyze individual birth defects because of small numbers, the researchers noted.
Nonetheless, the results suggest that “a mechanism could be that surgery-induced improvements in glucose metabolism, and potentially other beneficial physiologic changes, led to a reduction of major birth defect risk to a level similar to that of the general population,” they said.
Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.
SOURCE: Neovius M et al. JAMA. 2019 Oct 15; 322:1515-17.
FROM JAMA
Key clinical point: Infants whose mothers previously underwent gastric bypass surgery had a lower risk of birth defects than did the infants of matched controls.
Major finding: Major birth defects occurred in 3% of infants whose mothers had gastric bypass surgery, compared with 5% of infants born to control women.
Study details: The data come from a cohort study of 2,921 women with history of gastric bypass surgery and 30,573 matched controls.
Disclosures: Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.
Source: Neovius M et al. JAMA. 2019 Oct 15; 322:1515-17.
Pediatric stroke thrombectomy study sheds light on off-label procedure
based on data from a retrospective, multicenter study of 73 patients.
Children with high scores on the Pediatric National Institutes of Health Stroke Scale (PedNIHSS) or large-vessel occlusion in the anterior or posterior circulation are at increased risk for morbidity and mortality, but the safety of thrombectomy in children has not been well studied. Several randomized trials have showed its safety and efficacy in adults, wrote Peter Sporns, MD, of the Institute of Clinical Radiology at Universitätsklinikum Muenster (Germany), and colleagues.
In a study published in JAMA Neurology, Dr. Sporns and coauthors reviewed data from pediatric patients aged younger than 18 years who underwent endovascular recanalization between Jan. 1, 2000, and Dec. 31, 2018, at 25 stroke centers in Europe and 2 in the United States.
The primary outcome was change in the PedNIHSS scores and the endovascular recanalization involved “a combination of techniques using distal thrombaspiration and/or clot retrievers,” the researchers wrote.
Neurologic outcomes improved from a median PedNIHSS score of 14.0 at hospital admission to 4.0 at day 7. The average time from stroke onset to hospital admission was 3 hours, and the median time from stroke onset to recanalization was 4 hours.
“The rapidity of recanalization across the large number of centers in the Save ChildS study is a commendable achievement, establishing feasibility for acute pediatric stroke treatment within the short window of time for embolectomy at centers prepared for this event,” wrote Christine Fox, MD, of the University of California, San Francisco, and Nomazulu Dlamini, MBBS, PhD, of the Hospital for Sick Children, Toronto, in an accompanying editorial.
In addition, the median modified Rankin Scale score was 1.0 at discharge and at 6 and 24 months, and the median Pediatric Stroke Outcome Measure score was 1.0 at discharge and 0.5 at 6 and 24 months.
The median age of the patients was 11 years, and approximately half were boys (51%). A total of 63 children (86%) were treated for anterior circulation occlusion, and 10 (14%) were treated for posterior circulation occlusion; (22%) received concomitant intravenous thrombolysis.
Transient vasospasm was the only observed periprocedural complication, seen in four patients, and all cases resolved without clinical sequelae. One patient with a history of a heart anomaly died of cardiac arrest after recanalization. No vascular complications were reported, and the proportion of symptomatic intracerebral hemorrhage events was 1.37 per 100 observations, compared with 2.79 in a meta-analysis of adult studies.
The main limitation of the study was its retrospective design, as well as the absence of a control group, the researchers noted. However, the results “may support clinicians’ practice of off-label thrombectomy in childhood stroke in the absence of high-level evidence.”
The editorial authors emphasized that safety concerns remain despite the relatively low level of complications observed in the current study. “The safety of thrombectomy in children with suspected focal cerebral arteriopathy or bilateral arteriopathies is a particular concern because of the potential to further injure an acutely inflamed or chronically diseased vessel,” they wrote.
“We should be cautious about the interpretation of long-term outcome measures in the Save ChildS study,” Dr. Fox and Dr. Dlamini added, noting that additional multicenter studies are needed “to advance our knowledge of pediatric stroke and inform best practices.”
Dr. Sporns had no financial conflicts to disclose; several coauthors disclosed relationships with multiple pharmaceutical companies. Dr. Fox and Dr. Dlamini had no financial conflicts to disclose.
SOURCES: Sporns P et al. JAMA Neurol. 2019 Oct 14. doi: 10.1001/jamaneurol.2019.3403; Fox C, Dlamini N. JAMA Neurol. 2019 Oct 14. doi: 10.1001/jamaneurol.2019.3412.
based on data from a retrospective, multicenter study of 73 patients.
Children with high scores on the Pediatric National Institutes of Health Stroke Scale (PedNIHSS) or large-vessel occlusion in the anterior or posterior circulation are at increased risk for morbidity and mortality, but the safety of thrombectomy in children has not been well studied. Several randomized trials have showed its safety and efficacy in adults, wrote Peter Sporns, MD, of the Institute of Clinical Radiology at Universitätsklinikum Muenster (Germany), and colleagues.
In a study published in JAMA Neurology, Dr. Sporns and coauthors reviewed data from pediatric patients aged younger than 18 years who underwent endovascular recanalization between Jan. 1, 2000, and Dec. 31, 2018, at 25 stroke centers in Europe and 2 in the United States.
The primary outcome was change in the PedNIHSS scores and the endovascular recanalization involved “a combination of techniques using distal thrombaspiration and/or clot retrievers,” the researchers wrote.
Neurologic outcomes improved from a median PedNIHSS score of 14.0 at hospital admission to 4.0 at day 7. The average time from stroke onset to hospital admission was 3 hours, and the median time from stroke onset to recanalization was 4 hours.
“The rapidity of recanalization across the large number of centers in the Save ChildS study is a commendable achievement, establishing feasibility for acute pediatric stroke treatment within the short window of time for embolectomy at centers prepared for this event,” wrote Christine Fox, MD, of the University of California, San Francisco, and Nomazulu Dlamini, MBBS, PhD, of the Hospital for Sick Children, Toronto, in an accompanying editorial.
In addition, the median modified Rankin Scale score was 1.0 at discharge and at 6 and 24 months, and the median Pediatric Stroke Outcome Measure score was 1.0 at discharge and 0.5 at 6 and 24 months.
The median age of the patients was 11 years, and approximately half were boys (51%). A total of 63 children (86%) were treated for anterior circulation occlusion, and 10 (14%) were treated for posterior circulation occlusion; (22%) received concomitant intravenous thrombolysis.
Transient vasospasm was the only observed periprocedural complication, seen in four patients, and all cases resolved without clinical sequelae. One patient with a history of a heart anomaly died of cardiac arrest after recanalization. No vascular complications were reported, and the proportion of symptomatic intracerebral hemorrhage events was 1.37 per 100 observations, compared with 2.79 in a meta-analysis of adult studies.
The main limitation of the study was its retrospective design, as well as the absence of a control group, the researchers noted. However, the results “may support clinicians’ practice of off-label thrombectomy in childhood stroke in the absence of high-level evidence.”
The editorial authors emphasized that safety concerns remain despite the relatively low level of complications observed in the current study. “The safety of thrombectomy in children with suspected focal cerebral arteriopathy or bilateral arteriopathies is a particular concern because of the potential to further injure an acutely inflamed or chronically diseased vessel,” they wrote.
“We should be cautious about the interpretation of long-term outcome measures in the Save ChildS study,” Dr. Fox and Dr. Dlamini added, noting that additional multicenter studies are needed “to advance our knowledge of pediatric stroke and inform best practices.”
Dr. Sporns had no financial conflicts to disclose; several coauthors disclosed relationships with multiple pharmaceutical companies. Dr. Fox and Dr. Dlamini had no financial conflicts to disclose.
SOURCES: Sporns P et al. JAMA Neurol. 2019 Oct 14. doi: 10.1001/jamaneurol.2019.3403; Fox C, Dlamini N. JAMA Neurol. 2019 Oct 14. doi: 10.1001/jamaneurol.2019.3412.
based on data from a retrospective, multicenter study of 73 patients.
Children with high scores on the Pediatric National Institutes of Health Stroke Scale (PedNIHSS) or large-vessel occlusion in the anterior or posterior circulation are at increased risk for morbidity and mortality, but the safety of thrombectomy in children has not been well studied. Several randomized trials have showed its safety and efficacy in adults, wrote Peter Sporns, MD, of the Institute of Clinical Radiology at Universitätsklinikum Muenster (Germany), and colleagues.
In a study published in JAMA Neurology, Dr. Sporns and coauthors reviewed data from pediatric patients aged younger than 18 years who underwent endovascular recanalization between Jan. 1, 2000, and Dec. 31, 2018, at 25 stroke centers in Europe and 2 in the United States.
The primary outcome was change in the PedNIHSS scores and the endovascular recanalization involved “a combination of techniques using distal thrombaspiration and/or clot retrievers,” the researchers wrote.
Neurologic outcomes improved from a median PedNIHSS score of 14.0 at hospital admission to 4.0 at day 7. The average time from stroke onset to hospital admission was 3 hours, and the median time from stroke onset to recanalization was 4 hours.
“The rapidity of recanalization across the large number of centers in the Save ChildS study is a commendable achievement, establishing feasibility for acute pediatric stroke treatment within the short window of time for embolectomy at centers prepared for this event,” wrote Christine Fox, MD, of the University of California, San Francisco, and Nomazulu Dlamini, MBBS, PhD, of the Hospital for Sick Children, Toronto, in an accompanying editorial.
In addition, the median modified Rankin Scale score was 1.0 at discharge and at 6 and 24 months, and the median Pediatric Stroke Outcome Measure score was 1.0 at discharge and 0.5 at 6 and 24 months.
The median age of the patients was 11 years, and approximately half were boys (51%). A total of 63 children (86%) were treated for anterior circulation occlusion, and 10 (14%) were treated for posterior circulation occlusion; (22%) received concomitant intravenous thrombolysis.
Transient vasospasm was the only observed periprocedural complication, seen in four patients, and all cases resolved without clinical sequelae. One patient with a history of a heart anomaly died of cardiac arrest after recanalization. No vascular complications were reported, and the proportion of symptomatic intracerebral hemorrhage events was 1.37 per 100 observations, compared with 2.79 in a meta-analysis of adult studies.
The main limitation of the study was its retrospective design, as well as the absence of a control group, the researchers noted. However, the results “may support clinicians’ practice of off-label thrombectomy in childhood stroke in the absence of high-level evidence.”
The editorial authors emphasized that safety concerns remain despite the relatively low level of complications observed in the current study. “The safety of thrombectomy in children with suspected focal cerebral arteriopathy or bilateral arteriopathies is a particular concern because of the potential to further injure an acutely inflamed or chronically diseased vessel,” they wrote.
“We should be cautious about the interpretation of long-term outcome measures in the Save ChildS study,” Dr. Fox and Dr. Dlamini added, noting that additional multicenter studies are needed “to advance our knowledge of pediatric stroke and inform best practices.”
Dr. Sporns had no financial conflicts to disclose; several coauthors disclosed relationships with multiple pharmaceutical companies. Dr. Fox and Dr. Dlamini had no financial conflicts to disclose.
SOURCES: Sporns P et al. JAMA Neurol. 2019 Oct 14. doi: 10.1001/jamaneurol.2019.3403; Fox C, Dlamini N. JAMA Neurol. 2019 Oct 14. doi: 10.1001/jamaneurol.2019.3412.
FROM JAMA NEUROLOGY
Preop IV dexamethasone conveys relief after total knee surgery
Patients given a single preoperative dose of intravenous dexamethasone had significantly less pain after total knee arthroplasty than did those given a placebo in a randomized controlled study of 100 adults.
“Corticosteroids were introduced several years ago for relieving postoperative pain in total joint replacement but, unfortunately, are not widely used due to surgeons’ concerns and the limited supporting evidence,” wrote Nattapol Tammachote, MD, of Thammasat University, Khlong Luang, Pathumthani, Thailand, and colleagues.
In a study published in the Journal of Arthroplasty, the researchers randomized 50 adults undergoing unilateral total knee surgery to a preoperative IV dexamethasone dose of 0.15 mg/kg diluted with normal saline or saline placebo. Patients, who were aged 50-85 years, were assessed every 3 hours after surgery, up to 48 hours; the primary outcomes were pain level, using the visual analog pain scale (VAS), and morphine use.
Overall, patients in the treatment group reported significant reductions on the VAS in mean pain scores of 11 points at rest and 15 points with knee movement. No significant differences in morphine use were noted between groups overall or at 12-hour intervals post-surgery.
In the first 24-48 hours after surgery dexamethasone was associated with a significantly lower rate of nausea and vomiting vs. placebo (58% vs. 84%), and a lower average C-reactive protein level (89 mg/L vs. 167 mg/L) at 48 hours after surgery. Hospital stays averaged 3 days for both groups, and no wound infections were reported.
Scores on tests of knee function using the modified Western Ontario and McMaster University Osteoarthritis Index scores and range of motion of the knee at three months were similar between the groups.
The study findings were limited by several factors, including the small sample size and use of multimodal pain control that may have impacted morphine use, a lack of data on hyperglycemia, and variation in doses of ketorolac given to patients in both groups, the researchers noted.
The results nevertheless support the potential of preoperative dexamethasone as “a promising approach in postoperative pain management and may be suitable for patients with contraindication to multimodal pain regimens,” they concluded.
The researchers reported no financial conflicts.
SOURCE: Tammachote N et al. J Arthroplasty. 2019. doi: https://doi.org/10.1016/ j.arth.2019.09.002.
Patients given a single preoperative dose of intravenous dexamethasone had significantly less pain after total knee arthroplasty than did those given a placebo in a randomized controlled study of 100 adults.
“Corticosteroids were introduced several years ago for relieving postoperative pain in total joint replacement but, unfortunately, are not widely used due to surgeons’ concerns and the limited supporting evidence,” wrote Nattapol Tammachote, MD, of Thammasat University, Khlong Luang, Pathumthani, Thailand, and colleagues.
In a study published in the Journal of Arthroplasty, the researchers randomized 50 adults undergoing unilateral total knee surgery to a preoperative IV dexamethasone dose of 0.15 mg/kg diluted with normal saline or saline placebo. Patients, who were aged 50-85 years, were assessed every 3 hours after surgery, up to 48 hours; the primary outcomes were pain level, using the visual analog pain scale (VAS), and morphine use.
Overall, patients in the treatment group reported significant reductions on the VAS in mean pain scores of 11 points at rest and 15 points with knee movement. No significant differences in morphine use were noted between groups overall or at 12-hour intervals post-surgery.
In the first 24-48 hours after surgery dexamethasone was associated with a significantly lower rate of nausea and vomiting vs. placebo (58% vs. 84%), and a lower average C-reactive protein level (89 mg/L vs. 167 mg/L) at 48 hours after surgery. Hospital stays averaged 3 days for both groups, and no wound infections were reported.
Scores on tests of knee function using the modified Western Ontario and McMaster University Osteoarthritis Index scores and range of motion of the knee at three months were similar between the groups.
The study findings were limited by several factors, including the small sample size and use of multimodal pain control that may have impacted morphine use, a lack of data on hyperglycemia, and variation in doses of ketorolac given to patients in both groups, the researchers noted.
The results nevertheless support the potential of preoperative dexamethasone as “a promising approach in postoperative pain management and may be suitable for patients with contraindication to multimodal pain regimens,” they concluded.
The researchers reported no financial conflicts.
SOURCE: Tammachote N et al. J Arthroplasty. 2019. doi: https://doi.org/10.1016/ j.arth.2019.09.002.
Patients given a single preoperative dose of intravenous dexamethasone had significantly less pain after total knee arthroplasty than did those given a placebo in a randomized controlled study of 100 adults.
“Corticosteroids were introduced several years ago for relieving postoperative pain in total joint replacement but, unfortunately, are not widely used due to surgeons’ concerns and the limited supporting evidence,” wrote Nattapol Tammachote, MD, of Thammasat University, Khlong Luang, Pathumthani, Thailand, and colleagues.
In a study published in the Journal of Arthroplasty, the researchers randomized 50 adults undergoing unilateral total knee surgery to a preoperative IV dexamethasone dose of 0.15 mg/kg diluted with normal saline or saline placebo. Patients, who were aged 50-85 years, were assessed every 3 hours after surgery, up to 48 hours; the primary outcomes were pain level, using the visual analog pain scale (VAS), and morphine use.
Overall, patients in the treatment group reported significant reductions on the VAS in mean pain scores of 11 points at rest and 15 points with knee movement. No significant differences in morphine use were noted between groups overall or at 12-hour intervals post-surgery.
In the first 24-48 hours after surgery dexamethasone was associated with a significantly lower rate of nausea and vomiting vs. placebo (58% vs. 84%), and a lower average C-reactive protein level (89 mg/L vs. 167 mg/L) at 48 hours after surgery. Hospital stays averaged 3 days for both groups, and no wound infections were reported.
Scores on tests of knee function using the modified Western Ontario and McMaster University Osteoarthritis Index scores and range of motion of the knee at three months were similar between the groups.
The study findings were limited by several factors, including the small sample size and use of multimodal pain control that may have impacted morphine use, a lack of data on hyperglycemia, and variation in doses of ketorolac given to patients in both groups, the researchers noted.
The results nevertheless support the potential of preoperative dexamethasone as “a promising approach in postoperative pain management and may be suitable for patients with contraindication to multimodal pain regimens,” they concluded.
The researchers reported no financial conflicts.
SOURCE: Tammachote N et al. J Arthroplasty. 2019. doi: https://doi.org/10.1016/ j.arth.2019.09.002.
FROM THE JOURNAL OF ARTHROPLASTY