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Culturally Based Diabetes Education Aids Glycemic Control
Culturally based type 2 diabetes education programs improved patients' glycemic control for at least 6 months, based on results from a meta-analysis of 11 studies involving more than 1,000 patients.
“In some cases, cultural and communication barriers increase the problems minority ethnic communities experience in accessing good quality diabetes health education, a vital aspect contributing towards patient understanding, use of services, empowerment, and behaviour change towards healthier lifestyles,” the reviewers wrote in a report by the Cochrane Collaboration published online.
Overall, findings from the studies showed significant improvement in glycemic control (as measured by hemoglobin A1c levels) at 3- and 6-month follow-ups among patients who received culturally appropriate health education interventions, compared with control patients who received standard health education (described as “usual care”). This finding is clinically important if the improvement can be sustained, the reviewers noted, but the improvement in glycemic control was not significantly different between the groups at 12 months after the intervention.
In addition, patients in the intervention group showed significantly improved knowledge about diabetes and healthy lifestyles, compared with the control group at 3, 6, and 12 months after the intervention.
The report consisted of data from 11 trials including 1,603 individuals at least 16 years old who had type 2 diabetes. The patients were members of ethnic-minority groups in upper-middle-income or high-income countries. Previous studies have suggested that ethnic minorities in these countries have higher rates of type 2 diabetes, compared with the majority populations, and the investigators who conducted the studies theorized that culturally appropriate education would improve diabetes management in ethnic-minority patients. The primary outcome measure was glycemic control.
The studies included in the review took place in Europe, the United States, Canada, South Africa, New Zealand, and Australia. In most of the studies, the intervention was repeated several times for periods lasting from 6 to 12 weeks. None of the studies followed patients for more than 12 months from the start of the intervention (Cochrane Database Syst. Rev. 2008 [doi: 10.1002/14651858.CD006424.pub2]).
Culturally appropriate health education intervention was defined as “education that is tailored to the cultural or religious beliefs and linguistic skills of the community being approached, taking into account likely literacy skills,” the researchers wrote. The intervention strategies varied among the studies and included using community-based health advocates, providing education to same-gender groups, and adapting dietary advice to fit a community's available food options.
No significant improvements were found in most of the other clinical outcomes measured in the studies (including triglycerides, blood pressure, or weight) between patients who received culturally appropriate education intervention and those who received usual care. Total cholesterol was the exception—the intervention patients showed improvement in total cholesterol at 12 months, but not at 3 months or 6 months, compared with the control patients, based on data from the three studies that addressed this outcome.
No significant differences in quality of life were reported between patients who received culturally appropriate diabetes education and those who received standard education, according to findings from the three studies that addressed quality of life.
Despite the short duration of improvement, the findings suggest that culturally appropriate education programs can make a significant difference in diabetes control and are worth developing, the reviewers said.
“It has been known for some time that diabetes health education improves knowledge about diabetes as well as blood glucose control, but this review has shown that culturally appropriate health education is better than 'normal' practice for minority communities,” they wrote. “The results strengthen the belief, based on educational theory, that health education should be couched in a learner-centered manner that respects their religious, social, and cultural values in order to have the most impact.”
The lead review author, Dr. Kamila Hawthorne of Cardiff (Wales) University, was the author of one of the studies included in the review. The other reviewers had no conflicts of interest to disclose.
Culturally based type 2 diabetes education programs improved patients' glycemic control for at least 6 months, based on results from a meta-analysis of 11 studies involving more than 1,000 patients.
“In some cases, cultural and communication barriers increase the problems minority ethnic communities experience in accessing good quality diabetes health education, a vital aspect contributing towards patient understanding, use of services, empowerment, and behaviour change towards healthier lifestyles,” the reviewers wrote in a report by the Cochrane Collaboration published online.
Overall, findings from the studies showed significant improvement in glycemic control (as measured by hemoglobin A1c levels) at 3- and 6-month follow-ups among patients who received culturally appropriate health education interventions, compared with control patients who received standard health education (described as “usual care”). This finding is clinically important if the improvement can be sustained, the reviewers noted, but the improvement in glycemic control was not significantly different between the groups at 12 months after the intervention.
In addition, patients in the intervention group showed significantly improved knowledge about diabetes and healthy lifestyles, compared with the control group at 3, 6, and 12 months after the intervention.
The report consisted of data from 11 trials including 1,603 individuals at least 16 years old who had type 2 diabetes. The patients were members of ethnic-minority groups in upper-middle-income or high-income countries. Previous studies have suggested that ethnic minorities in these countries have higher rates of type 2 diabetes, compared with the majority populations, and the investigators who conducted the studies theorized that culturally appropriate education would improve diabetes management in ethnic-minority patients. The primary outcome measure was glycemic control.
The studies included in the review took place in Europe, the United States, Canada, South Africa, New Zealand, and Australia. In most of the studies, the intervention was repeated several times for periods lasting from 6 to 12 weeks. None of the studies followed patients for more than 12 months from the start of the intervention (Cochrane Database Syst. Rev. 2008 [doi: 10.1002/14651858.CD006424.pub2]).
Culturally appropriate health education intervention was defined as “education that is tailored to the cultural or religious beliefs and linguistic skills of the community being approached, taking into account likely literacy skills,” the researchers wrote. The intervention strategies varied among the studies and included using community-based health advocates, providing education to same-gender groups, and adapting dietary advice to fit a community's available food options.
No significant improvements were found in most of the other clinical outcomes measured in the studies (including triglycerides, blood pressure, or weight) between patients who received culturally appropriate education intervention and those who received usual care. Total cholesterol was the exception—the intervention patients showed improvement in total cholesterol at 12 months, but not at 3 months or 6 months, compared with the control patients, based on data from the three studies that addressed this outcome.
No significant differences in quality of life were reported between patients who received culturally appropriate diabetes education and those who received standard education, according to findings from the three studies that addressed quality of life.
Despite the short duration of improvement, the findings suggest that culturally appropriate education programs can make a significant difference in diabetes control and are worth developing, the reviewers said.
“It has been known for some time that diabetes health education improves knowledge about diabetes as well as blood glucose control, but this review has shown that culturally appropriate health education is better than 'normal' practice for minority communities,” they wrote. “The results strengthen the belief, based on educational theory, that health education should be couched in a learner-centered manner that respects their religious, social, and cultural values in order to have the most impact.”
The lead review author, Dr. Kamila Hawthorne of Cardiff (Wales) University, was the author of one of the studies included in the review. The other reviewers had no conflicts of interest to disclose.
Culturally based type 2 diabetes education programs improved patients' glycemic control for at least 6 months, based on results from a meta-analysis of 11 studies involving more than 1,000 patients.
“In some cases, cultural and communication barriers increase the problems minority ethnic communities experience in accessing good quality diabetes health education, a vital aspect contributing towards patient understanding, use of services, empowerment, and behaviour change towards healthier lifestyles,” the reviewers wrote in a report by the Cochrane Collaboration published online.
Overall, findings from the studies showed significant improvement in glycemic control (as measured by hemoglobin A1c levels) at 3- and 6-month follow-ups among patients who received culturally appropriate health education interventions, compared with control patients who received standard health education (described as “usual care”). This finding is clinically important if the improvement can be sustained, the reviewers noted, but the improvement in glycemic control was not significantly different between the groups at 12 months after the intervention.
In addition, patients in the intervention group showed significantly improved knowledge about diabetes and healthy lifestyles, compared with the control group at 3, 6, and 12 months after the intervention.
The report consisted of data from 11 trials including 1,603 individuals at least 16 years old who had type 2 diabetes. The patients were members of ethnic-minority groups in upper-middle-income or high-income countries. Previous studies have suggested that ethnic minorities in these countries have higher rates of type 2 diabetes, compared with the majority populations, and the investigators who conducted the studies theorized that culturally appropriate education would improve diabetes management in ethnic-minority patients. The primary outcome measure was glycemic control.
The studies included in the review took place in Europe, the United States, Canada, South Africa, New Zealand, and Australia. In most of the studies, the intervention was repeated several times for periods lasting from 6 to 12 weeks. None of the studies followed patients for more than 12 months from the start of the intervention (Cochrane Database Syst. Rev. 2008 [doi: 10.1002/14651858.CD006424.pub2]).
Culturally appropriate health education intervention was defined as “education that is tailored to the cultural or religious beliefs and linguistic skills of the community being approached, taking into account likely literacy skills,” the researchers wrote. The intervention strategies varied among the studies and included using community-based health advocates, providing education to same-gender groups, and adapting dietary advice to fit a community's available food options.
No significant improvements were found in most of the other clinical outcomes measured in the studies (including triglycerides, blood pressure, or weight) between patients who received culturally appropriate education intervention and those who received usual care. Total cholesterol was the exception—the intervention patients showed improvement in total cholesterol at 12 months, but not at 3 months or 6 months, compared with the control patients, based on data from the three studies that addressed this outcome.
No significant differences in quality of life were reported between patients who received culturally appropriate diabetes education and those who received standard education, according to findings from the three studies that addressed quality of life.
Despite the short duration of improvement, the findings suggest that culturally appropriate education programs can make a significant difference in diabetes control and are worth developing, the reviewers said.
“It has been known for some time that diabetes health education improves knowledge about diabetes as well as blood glucose control, but this review has shown that culturally appropriate health education is better than 'normal' practice for minority communities,” they wrote. “The results strengthen the belief, based on educational theory, that health education should be couched in a learner-centered manner that respects their religious, social, and cultural values in order to have the most impact.”
The lead review author, Dr. Kamila Hawthorne of Cardiff (Wales) University, was the author of one of the studies included in the review. The other reviewers had no conflicts of interest to disclose.
Ondansetron May Curb Vomiting in Gastroenteritis
Ondansetron therapy effectively reduced vomiting and other emetic complications—including hospital admissions—in children with acute gastroenteritis, based on results from a meta-analysis.
Current practice guidelines for treating children with gastroenteritis recommend oral rehydration therapy, but the guidelines don't recommend a drug treatment for vomiting, wrote Dr. Lisa Ross DeCamp and her colleagues at the University of North Carolina at Chapel Hill.
Vomiting may undermine oral rehydration therapy, and it is stressful for the children and their families (Arch. Pediatr. Adolesc. Med. 2008;?162:858-65).
To determine the value of antiemetics in relieving vomiting, the investigators reviewed findings from 11 studies on this topic. Several studies involved more than one drug.
The antiemetics included ondansetron (six studies), domperidone (two studies), trimethobenzamide (two studies), pyrilamine-pentobarbital (two studies), metoclopramide (two studies), dexamethasone (one study), and promethazine (one study).
Combined data from six randomized, double-blind, placebo-controlled trials including 745 children showed that ondansetron significantly reduced the risk of additional vomiting, the need for intravenous fluid (IVF), and the need for hospital admission, compared with a placebo.
Although the use of ondansetron was associated with increased diarrhea within 48 hours of administration in three studies, this effect did not appear to increase health care use and it did not persist beyond 48 hours.
No other serious adverse events were reported in connection with ondansetron use.
Overall, the numbers of children needed to treat with ondansetron to prevent hospital admission, IVF use, and further vomiting for 1 child were 14, 5, and 5 children, respectively.
Doses of ondansetron ranged from 2 mg to 8 mg when given orally using weight-based dosing and 1.6–4.0 mg when given orally using age-based dosing. The intravenous ondansetron dosage ranged from 0.3 mg/kg to 0.15 mg/kg.
“Studies of antiemetic agents other than ondansetron had small sample sizes, were of low methodological quality, and produced inconsistent results,” the researchers explained.
The results were limited by the fact that the ondansetron studies included in this review were supported by GlaxoSmithKline, a manufacturer of ondansetron (Zofran). But ondansetron is available in a generic form, and additional studies, including cost-effectiveness studies, should not require industry support, the researchers noted.
Most of the studies in this review focused on moderately ill children who were treated in an emergency department. These children are generally at greater risk for hospitalization or IVF treatment than are children who present to primary care offices, the researchers added.
“Given the costs associated with IVF or hospital admission and the relatively low [numbers needed to treat] demonstrated in the present study, ondansetron use in [emergency departments] is likely to be cost effective,” they wrote.
No known data exist on the use of ondansetron to treat pediatric vomiting in general office settings, and more studies are needed to evaluate outcomes after ondansetron use in these settings.
“There is not sufficient evidence to recommend the use of ondansetron for pediatric [gastroenteritis] in outpatient settings, or among children with mild disease,” Dr. Rachel C. Vreeman of Indiana University, Indianapolis, and her colleagues wrote in an accompanying editorial (Arch. Pediatr. Adolesc. Med. 2008;162:866-9).
Dr. DeCamp and her colleagues and Dr. Vreeman and her colleagues stated that they had no financial conflicts.
Ondansetron therapy effectively reduced vomiting and other emetic complications—including hospital admissions—in children with acute gastroenteritis, based on results from a meta-analysis.
Current practice guidelines for treating children with gastroenteritis recommend oral rehydration therapy, but the guidelines don't recommend a drug treatment for vomiting, wrote Dr. Lisa Ross DeCamp and her colleagues at the University of North Carolina at Chapel Hill.
Vomiting may undermine oral rehydration therapy, and it is stressful for the children and their families (Arch. Pediatr. Adolesc. Med. 2008;?162:858-65).
To determine the value of antiemetics in relieving vomiting, the investigators reviewed findings from 11 studies on this topic. Several studies involved more than one drug.
The antiemetics included ondansetron (six studies), domperidone (two studies), trimethobenzamide (two studies), pyrilamine-pentobarbital (two studies), metoclopramide (two studies), dexamethasone (one study), and promethazine (one study).
Combined data from six randomized, double-blind, placebo-controlled trials including 745 children showed that ondansetron significantly reduced the risk of additional vomiting, the need for intravenous fluid (IVF), and the need for hospital admission, compared with a placebo.
Although the use of ondansetron was associated with increased diarrhea within 48 hours of administration in three studies, this effect did not appear to increase health care use and it did not persist beyond 48 hours.
No other serious adverse events were reported in connection with ondansetron use.
Overall, the numbers of children needed to treat with ondansetron to prevent hospital admission, IVF use, and further vomiting for 1 child were 14, 5, and 5 children, respectively.
Doses of ondansetron ranged from 2 mg to 8 mg when given orally using weight-based dosing and 1.6–4.0 mg when given orally using age-based dosing. The intravenous ondansetron dosage ranged from 0.3 mg/kg to 0.15 mg/kg.
“Studies of antiemetic agents other than ondansetron had small sample sizes, were of low methodological quality, and produced inconsistent results,” the researchers explained.
The results were limited by the fact that the ondansetron studies included in this review were supported by GlaxoSmithKline, a manufacturer of ondansetron (Zofran). But ondansetron is available in a generic form, and additional studies, including cost-effectiveness studies, should not require industry support, the researchers noted.
Most of the studies in this review focused on moderately ill children who were treated in an emergency department. These children are generally at greater risk for hospitalization or IVF treatment than are children who present to primary care offices, the researchers added.
“Given the costs associated with IVF or hospital admission and the relatively low [numbers needed to treat] demonstrated in the present study, ondansetron use in [emergency departments] is likely to be cost effective,” they wrote.
No known data exist on the use of ondansetron to treat pediatric vomiting in general office settings, and more studies are needed to evaluate outcomes after ondansetron use in these settings.
“There is not sufficient evidence to recommend the use of ondansetron for pediatric [gastroenteritis] in outpatient settings, or among children with mild disease,” Dr. Rachel C. Vreeman of Indiana University, Indianapolis, and her colleagues wrote in an accompanying editorial (Arch. Pediatr. Adolesc. Med. 2008;162:866-9).
Dr. DeCamp and her colleagues and Dr. Vreeman and her colleagues stated that they had no financial conflicts.
Ondansetron therapy effectively reduced vomiting and other emetic complications—including hospital admissions—in children with acute gastroenteritis, based on results from a meta-analysis.
Current practice guidelines for treating children with gastroenteritis recommend oral rehydration therapy, but the guidelines don't recommend a drug treatment for vomiting, wrote Dr. Lisa Ross DeCamp and her colleagues at the University of North Carolina at Chapel Hill.
Vomiting may undermine oral rehydration therapy, and it is stressful for the children and their families (Arch. Pediatr. Adolesc. Med. 2008;?162:858-65).
To determine the value of antiemetics in relieving vomiting, the investigators reviewed findings from 11 studies on this topic. Several studies involved more than one drug.
The antiemetics included ondansetron (six studies), domperidone (two studies), trimethobenzamide (two studies), pyrilamine-pentobarbital (two studies), metoclopramide (two studies), dexamethasone (one study), and promethazine (one study).
Combined data from six randomized, double-blind, placebo-controlled trials including 745 children showed that ondansetron significantly reduced the risk of additional vomiting, the need for intravenous fluid (IVF), and the need for hospital admission, compared with a placebo.
Although the use of ondansetron was associated with increased diarrhea within 48 hours of administration in three studies, this effect did not appear to increase health care use and it did not persist beyond 48 hours.
No other serious adverse events were reported in connection with ondansetron use.
Overall, the numbers of children needed to treat with ondansetron to prevent hospital admission, IVF use, and further vomiting for 1 child were 14, 5, and 5 children, respectively.
Doses of ondansetron ranged from 2 mg to 8 mg when given orally using weight-based dosing and 1.6–4.0 mg when given orally using age-based dosing. The intravenous ondansetron dosage ranged from 0.3 mg/kg to 0.15 mg/kg.
“Studies of antiemetic agents other than ondansetron had small sample sizes, were of low methodological quality, and produced inconsistent results,” the researchers explained.
The results were limited by the fact that the ondansetron studies included in this review were supported by GlaxoSmithKline, a manufacturer of ondansetron (Zofran). But ondansetron is available in a generic form, and additional studies, including cost-effectiveness studies, should not require industry support, the researchers noted.
Most of the studies in this review focused on moderately ill children who were treated in an emergency department. These children are generally at greater risk for hospitalization or IVF treatment than are children who present to primary care offices, the researchers added.
“Given the costs associated with IVF or hospital admission and the relatively low [numbers needed to treat] demonstrated in the present study, ondansetron use in [emergency departments] is likely to be cost effective,” they wrote.
No known data exist on the use of ondansetron to treat pediatric vomiting in general office settings, and more studies are needed to evaluate outcomes after ondansetron use in these settings.
“There is not sufficient evidence to recommend the use of ondansetron for pediatric [gastroenteritis] in outpatient settings, or among children with mild disease,” Dr. Rachel C. Vreeman of Indiana University, Indianapolis, and her colleagues wrote in an accompanying editorial (Arch. Pediatr. Adolesc. Med. 2008;162:866-9).
Dr. DeCamp and her colleagues and Dr. Vreeman and her colleagues stated that they had no financial conflicts.
Biopsy Data Refute MMR Vaccine and Autism Link
The measles, mumps, and rubella vaccine was not associated with a diagnosis of autism in children aged 3–10 years, based on data from 25 children with autism and 13 controls.
These findings contradict the results of a 2002 study in which traces of the measles virus were found in biopsies from the bowel tissue of children with autism. The data from the 2002 study suggested that the live virus from the measles, mumps, and rubella (MMR) vaccine would lodge and grow in a child's intestinal tract, causing damage there. The hypothesis was that the virus also would cause inflammation and damage to the central nervous system, resulting in autism symptoms. But if this theory was correct, then tissue biopsies from autistic children should show traces of the MMR vaccine, whereas biopsies from control children without autism should not, the researchers noted.
The current study also refutes a decade-old study that first suggested that the onset of behavioral abnormalities in a small group of children who had autism spectrum disorders and GI problems coincided with their having received the MMR vaccine.
To identify a possible link between measles virus in the GI tract and autism, Dr. Mady Hornig of Columbia University, New York, and colleagues examined bowel tissue from children with autism spectrum disorders and GI problems. They compared the biopsies with bowel tissue from children who had GI problems but did not have autism (PLoS ONE 2008;3:e3140).
The researchers found no significant differences in the presence of RNA from the measles virus in the biopsies from the autistic children, compared with the children who weren't autistic. All the children had received the MMR vaccine, but the researchers found trace amounts of measles RNA (fewer than 10 copies) in only one child with autism and one control child. Autism diagnoses were confirmed by child neurologists, psychiatrists, or developmental pediatricians.
The average age of the autism and control groups at the time of the first MMR vaccination was 15 months and 16 months, respectively, and the average interval between the MMR vaccination and the tissue biopsy was 41 months and 40 months, respectively.
A total of 12 of the 25 autistic children (48%) received MMR vaccine before their GI problems began, compared with 3 of 13 controls (23%). But this difference was not statistically significant. Children with autism who received the first MMR vaccine before the onset of their GI problems were significantly older when their GI problems began, compared with the children with autism who had GI problems before they received the vaccine. By contrast, children with GI problems before their autism diagnoses were significantly younger than children who developed GI problems after they were diagnosed with autism. A chi square analysis “indicated no role for MMR in either the pathogenesis of autism or GI dysfunction,” Dr. Hornig and colleagues noted.
“If MMR is causally related to either GI disturbances or autism it should precede their onset,” the researchers wrote. Instead, they found that the order of MMR vaccine administration, the onset of GI problems, and the onset of autism was “inconsistent with a causal role for MMR vaccine as a trigger or exacerbator of either GI disturbances or autism,” they explained.
The study was limited by the small group of children, but no previous studies have examined the tissue from children with autism and GI problems specifically to assess links to vaccines.
The characteristics of GI problems within the population of children with autism remain unclear, and more research is needed to determine any relationships between vaccines and autism spectrum disorders.
The study was supported in part by a grant from the Centers for Disease Control and Prevention to the American Academy of Pediatrics, and by an award from the National Institutes of Health.
Dr. Hornig stated that she had no relevant financial conflicts to disclose.
The measles, mumps, and rubella vaccine was not associated with a diagnosis of autism in children aged 3–10 years, based on data from 25 children with autism and 13 controls.
These findings contradict the results of a 2002 study in which traces of the measles virus were found in biopsies from the bowel tissue of children with autism. The data from the 2002 study suggested that the live virus from the measles, mumps, and rubella (MMR) vaccine would lodge and grow in a child's intestinal tract, causing damage there. The hypothesis was that the virus also would cause inflammation and damage to the central nervous system, resulting in autism symptoms. But if this theory was correct, then tissue biopsies from autistic children should show traces of the MMR vaccine, whereas biopsies from control children without autism should not, the researchers noted.
The current study also refutes a decade-old study that first suggested that the onset of behavioral abnormalities in a small group of children who had autism spectrum disorders and GI problems coincided with their having received the MMR vaccine.
To identify a possible link between measles virus in the GI tract and autism, Dr. Mady Hornig of Columbia University, New York, and colleagues examined bowel tissue from children with autism spectrum disorders and GI problems. They compared the biopsies with bowel tissue from children who had GI problems but did not have autism (PLoS ONE 2008;3:e3140).
The researchers found no significant differences in the presence of RNA from the measles virus in the biopsies from the autistic children, compared with the children who weren't autistic. All the children had received the MMR vaccine, but the researchers found trace amounts of measles RNA (fewer than 10 copies) in only one child with autism and one control child. Autism diagnoses were confirmed by child neurologists, psychiatrists, or developmental pediatricians.
The average age of the autism and control groups at the time of the first MMR vaccination was 15 months and 16 months, respectively, and the average interval between the MMR vaccination and the tissue biopsy was 41 months and 40 months, respectively.
A total of 12 of the 25 autistic children (48%) received MMR vaccine before their GI problems began, compared with 3 of 13 controls (23%). But this difference was not statistically significant. Children with autism who received the first MMR vaccine before the onset of their GI problems were significantly older when their GI problems began, compared with the children with autism who had GI problems before they received the vaccine. By contrast, children with GI problems before their autism diagnoses were significantly younger than children who developed GI problems after they were diagnosed with autism. A chi square analysis “indicated no role for MMR in either the pathogenesis of autism or GI dysfunction,” Dr. Hornig and colleagues noted.
“If MMR is causally related to either GI disturbances or autism it should precede their onset,” the researchers wrote. Instead, they found that the order of MMR vaccine administration, the onset of GI problems, and the onset of autism was “inconsistent with a causal role for MMR vaccine as a trigger or exacerbator of either GI disturbances or autism,” they explained.
The study was limited by the small group of children, but no previous studies have examined the tissue from children with autism and GI problems specifically to assess links to vaccines.
The characteristics of GI problems within the population of children with autism remain unclear, and more research is needed to determine any relationships between vaccines and autism spectrum disorders.
The study was supported in part by a grant from the Centers for Disease Control and Prevention to the American Academy of Pediatrics, and by an award from the National Institutes of Health.
Dr. Hornig stated that she had no relevant financial conflicts to disclose.
The measles, mumps, and rubella vaccine was not associated with a diagnosis of autism in children aged 3–10 years, based on data from 25 children with autism and 13 controls.
These findings contradict the results of a 2002 study in which traces of the measles virus were found in biopsies from the bowel tissue of children with autism. The data from the 2002 study suggested that the live virus from the measles, mumps, and rubella (MMR) vaccine would lodge and grow in a child's intestinal tract, causing damage there. The hypothesis was that the virus also would cause inflammation and damage to the central nervous system, resulting in autism symptoms. But if this theory was correct, then tissue biopsies from autistic children should show traces of the MMR vaccine, whereas biopsies from control children without autism should not, the researchers noted.
The current study also refutes a decade-old study that first suggested that the onset of behavioral abnormalities in a small group of children who had autism spectrum disorders and GI problems coincided with their having received the MMR vaccine.
To identify a possible link between measles virus in the GI tract and autism, Dr. Mady Hornig of Columbia University, New York, and colleagues examined bowel tissue from children with autism spectrum disorders and GI problems. They compared the biopsies with bowel tissue from children who had GI problems but did not have autism (PLoS ONE 2008;3:e3140).
The researchers found no significant differences in the presence of RNA from the measles virus in the biopsies from the autistic children, compared with the children who weren't autistic. All the children had received the MMR vaccine, but the researchers found trace amounts of measles RNA (fewer than 10 copies) in only one child with autism and one control child. Autism diagnoses were confirmed by child neurologists, psychiatrists, or developmental pediatricians.
The average age of the autism and control groups at the time of the first MMR vaccination was 15 months and 16 months, respectively, and the average interval between the MMR vaccination and the tissue biopsy was 41 months and 40 months, respectively.
A total of 12 of the 25 autistic children (48%) received MMR vaccine before their GI problems began, compared with 3 of 13 controls (23%). But this difference was not statistically significant. Children with autism who received the first MMR vaccine before the onset of their GI problems were significantly older when their GI problems began, compared with the children with autism who had GI problems before they received the vaccine. By contrast, children with GI problems before their autism diagnoses were significantly younger than children who developed GI problems after they were diagnosed with autism. A chi square analysis “indicated no role for MMR in either the pathogenesis of autism or GI dysfunction,” Dr. Hornig and colleagues noted.
“If MMR is causally related to either GI disturbances or autism it should precede their onset,” the researchers wrote. Instead, they found that the order of MMR vaccine administration, the onset of GI problems, and the onset of autism was “inconsistent with a causal role for MMR vaccine as a trigger or exacerbator of either GI disturbances or autism,” they explained.
The study was limited by the small group of children, but no previous studies have examined the tissue from children with autism and GI problems specifically to assess links to vaccines.
The characteristics of GI problems within the population of children with autism remain unclear, and more research is needed to determine any relationships between vaccines and autism spectrum disorders.
The study was supported in part by a grant from the Centers for Disease Control and Prevention to the American Academy of Pediatrics, and by an award from the National Institutes of Health.
Dr. Hornig stated that she had no relevant financial conflicts to disclose.
New Child Biopsy Data Refute Link Between Measles, Mumps, Rubella Vaccine and Autism
The measles, mumps, and rubella vaccine was not associated with a diagnosis of autism in children who were aged 310 years, based on data from 25 children with autism and 13 controls.
These findings contradict the results of a 2002 study in which traces of the measles virus were found in biopsies taken from the bowel tissue of children with autism. The data from the 2002 study suggested that the live virus from the measles, mumps, and rubella (MMR) vaccine would lodge and grow in a child's intestinal tract, causing damage there.
The hypothesis was that the virus also would cause inflammation and damage to the central nervous system, resulting in autism symptoms.
If this theory was correct, however, then tissue biopsies from autistic children should show traces of the MMR vaccine, whereas biopsies from control children without autism should not, the researchers noted.
The current study also refutes a decade-old study that first suggested that the onset of behavioral abnormalities in a small group of children who had autism spectrum disorders and gastrointestinal problems coincided with their having received the MMR vaccine.
To identify a possible link between measles virus in the GI tract and autism, Dr. Mady Hornig of Columbia University in New York, and colleagues examined bowel tissue from children with autism spectrum disorders and GI problems. They compared the biopsies with bowel tissue from children who had GI problems but did not have autism (PLoS ONE 2008;3:e3140).
The researchers found that there were no significant differences in the presence of RNA from the measles virus in the biopsies from the autistic children, compared with the children who were not autistic.
All of the children had received the MMR vaccine, but the researchers detected trace amounts of measles RNA (fewer than 10 copies) in only one child with autism and one control child.
The average age of the autism and control groups at the time of the first MMR vaccination was 15 months and 16 months, respectively; the average interval between the MMR vaccination and the tissue biopsy was 41 months and 40 months, respectively. A total of 12 of the 25 (48%) autistic children had received MMR vaccine before their GI problems began, compared with 3 of 13 (23%) controls. But this difference was not statistically significant.
Children with autism who received the first MMR vaccine before the onset of their GI problems were significantly older when their GI problems began, compared with the children with autism who had GI problems before they received the vaccine. Children with GI problems before their autism diagnoses were significantly younger than children who developed GI problems after they were diagnosed with autism. A chi-square analysis "indicated no role for MMR in either the pathogenesis of autism or GI dysfunction," Dr. Hornig and colleagues noted.
"If MMR is causally related to either GI disturbances or autism it should precede their onset," the researchers wrote. Instead, they found that the order of MMR vaccine administration, the onset of GI problems, and the onset of autism was "inconsistent with a causal role for MMR vaccine as a trigger or exacerbator of either GI disturbances or autism," they explained.
The study was limited by the small group of children, but no previous studies have examined the tissue from children with autism and gastrointestinal problems specifically to assess links to vaccines. The characteristics of gastrointestinal problems within the population of children with autism remain unclear, and more research is needed, Dr. Hornig and associates added.
The study was supported in part by a grant from the Centers for Disease Control and Prevention to the American Academy of Pediatrics, and by an award from the National Institutes of Health. Dr. Hornig disclosed no financial conflicts.
The measles, mumps, and rubella vaccine was not associated with a diagnosis of autism in children who were aged 310 years, based on data from 25 children with autism and 13 controls.
These findings contradict the results of a 2002 study in which traces of the measles virus were found in biopsies taken from the bowel tissue of children with autism. The data from the 2002 study suggested that the live virus from the measles, mumps, and rubella (MMR) vaccine would lodge and grow in a child's intestinal tract, causing damage there.
The hypothesis was that the virus also would cause inflammation and damage to the central nervous system, resulting in autism symptoms.
If this theory was correct, however, then tissue biopsies from autistic children should show traces of the MMR vaccine, whereas biopsies from control children without autism should not, the researchers noted.
The current study also refutes a decade-old study that first suggested that the onset of behavioral abnormalities in a small group of children who had autism spectrum disorders and gastrointestinal problems coincided with their having received the MMR vaccine.
To identify a possible link between measles virus in the GI tract and autism, Dr. Mady Hornig of Columbia University in New York, and colleagues examined bowel tissue from children with autism spectrum disorders and GI problems. They compared the biopsies with bowel tissue from children who had GI problems but did not have autism (PLoS ONE 2008;3:e3140).
The researchers found that there were no significant differences in the presence of RNA from the measles virus in the biopsies from the autistic children, compared with the children who were not autistic.
All of the children had received the MMR vaccine, but the researchers detected trace amounts of measles RNA (fewer than 10 copies) in only one child with autism and one control child.
The average age of the autism and control groups at the time of the first MMR vaccination was 15 months and 16 months, respectively; the average interval between the MMR vaccination and the tissue biopsy was 41 months and 40 months, respectively. A total of 12 of the 25 (48%) autistic children had received MMR vaccine before their GI problems began, compared with 3 of 13 (23%) controls. But this difference was not statistically significant.
Children with autism who received the first MMR vaccine before the onset of their GI problems were significantly older when their GI problems began, compared with the children with autism who had GI problems before they received the vaccine. Children with GI problems before their autism diagnoses were significantly younger than children who developed GI problems after they were diagnosed with autism. A chi-square analysis "indicated no role for MMR in either the pathogenesis of autism or GI dysfunction," Dr. Hornig and colleagues noted.
"If MMR is causally related to either GI disturbances or autism it should precede their onset," the researchers wrote. Instead, they found that the order of MMR vaccine administration, the onset of GI problems, and the onset of autism was "inconsistent with a causal role for MMR vaccine as a trigger or exacerbator of either GI disturbances or autism," they explained.
The study was limited by the small group of children, but no previous studies have examined the tissue from children with autism and gastrointestinal problems specifically to assess links to vaccines. The characteristics of gastrointestinal problems within the population of children with autism remain unclear, and more research is needed, Dr. Hornig and associates added.
The study was supported in part by a grant from the Centers for Disease Control and Prevention to the American Academy of Pediatrics, and by an award from the National Institutes of Health. Dr. Hornig disclosed no financial conflicts.
The measles, mumps, and rubella vaccine was not associated with a diagnosis of autism in children who were aged 310 years, based on data from 25 children with autism and 13 controls.
These findings contradict the results of a 2002 study in which traces of the measles virus were found in biopsies taken from the bowel tissue of children with autism. The data from the 2002 study suggested that the live virus from the measles, mumps, and rubella (MMR) vaccine would lodge and grow in a child's intestinal tract, causing damage there.
The hypothesis was that the virus also would cause inflammation and damage to the central nervous system, resulting in autism symptoms.
If this theory was correct, however, then tissue biopsies from autistic children should show traces of the MMR vaccine, whereas biopsies from control children without autism should not, the researchers noted.
The current study also refutes a decade-old study that first suggested that the onset of behavioral abnormalities in a small group of children who had autism spectrum disorders and gastrointestinal problems coincided with their having received the MMR vaccine.
To identify a possible link between measles virus in the GI tract and autism, Dr. Mady Hornig of Columbia University in New York, and colleagues examined bowel tissue from children with autism spectrum disorders and GI problems. They compared the biopsies with bowel tissue from children who had GI problems but did not have autism (PLoS ONE 2008;3:e3140).
The researchers found that there were no significant differences in the presence of RNA from the measles virus in the biopsies from the autistic children, compared with the children who were not autistic.
All of the children had received the MMR vaccine, but the researchers detected trace amounts of measles RNA (fewer than 10 copies) in only one child with autism and one control child.
The average age of the autism and control groups at the time of the first MMR vaccination was 15 months and 16 months, respectively; the average interval between the MMR vaccination and the tissue biopsy was 41 months and 40 months, respectively. A total of 12 of the 25 (48%) autistic children had received MMR vaccine before their GI problems began, compared with 3 of 13 (23%) controls. But this difference was not statistically significant.
Children with autism who received the first MMR vaccine before the onset of their GI problems were significantly older when their GI problems began, compared with the children with autism who had GI problems before they received the vaccine. Children with GI problems before their autism diagnoses were significantly younger than children who developed GI problems after they were diagnosed with autism. A chi-square analysis "indicated no role for MMR in either the pathogenesis of autism or GI dysfunction," Dr. Hornig and colleagues noted.
"If MMR is causally related to either GI disturbances or autism it should precede their onset," the researchers wrote. Instead, they found that the order of MMR vaccine administration, the onset of GI problems, and the onset of autism was "inconsistent with a causal role for MMR vaccine as a trigger or exacerbator of either GI disturbances or autism," they explained.
The study was limited by the small group of children, but no previous studies have examined the tissue from children with autism and gastrointestinal problems specifically to assess links to vaccines. The characteristics of gastrointestinal problems within the population of children with autism remain unclear, and more research is needed, Dr. Hornig and associates added.
The study was supported in part by a grant from the Centers for Disease Control and Prevention to the American Academy of Pediatrics, and by an award from the National Institutes of Health. Dr. Hornig disclosed no financial conflicts.
Safety Tops Mothers' HPV Vaccine Concerns
Safety, not sexuality, was a key factor in the reluctance of mothers to have their teenage daughters vaccinated against human papillomavirus, according to results from a study published in the Journal of Adolescent Health.
The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices currently recommends a three-dose vaccine against the human papillomavirus (HPV) for all girls aged 1112 years and young women aged 1326 years. HPV has been identified as a leading cause of cervical cancer.
Previous studies have shown that parents were in favor of vaccination for adolescents but hesitant to vaccinate younger girls. In most cases, though, this resistance was not brought on by concerns that the vaccination might make teenage girls more likely to engage in risky sexual activities.
To examine the factors that influence parents' acceptance of the HPV vaccine, Susan L. Rosenthal, Ph.D., of the University of Texas Medical Branch in Galveston, Tex., and her colleagues interviewed mothers with daughters aged 1117 years who were visitors to a university-based primary care clinic.
The study included complete results from 153 mothers of various ethnicities (average age 41 years) who completed a questionnaire. The questionnaire included ratings of seven health beliefs including perceptions of HPV disease severity and barriers to vaccination, such as cost. The questionnaire also addressed aspects of the parent/child relationship, including how closely the girls' activities were monitored by parents and whether the parents had discussed topics such as birth control, dating, and making decisions about sex (J. Adolesc. Health 2008;43:23945).
Overall, 18% (27) of the mothers had been offered the HPV vaccination for their daughters but had not chosen it, and did not plan to vaccinate their daughters within the next year, while 34% (52) had not been offered the vaccination and did not plan to vaccinate their daughters within the next year. Another 22% (34) had not been offered the vaccine but were aware of it and planned to vaccinate their daughters within the next year, and 26% (40) of the mothers reported that their daughters had started or completed the vaccination series.
None of the mothers whose daughters had been vaccinated said they viewed the vaccine as unsafe, but objections to the vaccine were focused mostly on the lack of safety data because of the newness of the vaccine. Mothers who were offered the vaccine but did not plan to vaccinate their daughters within the year often cited a lack information about the vaccine, and some cited a lack of urgency based on their perceptions of their daughters' likely exposure to HPV.
Significant predictors of HPV vaccination after a multivariate analysis were mothers who had less than a high school education, had a history of sexually transmitted infections, had monitored their daughters' activities with peers, and had thought their daughters would not mind getting the shots.
There was no significant association between HPV vaccine acceptance and the ages and ethnicities of the mothers and daughters, the daughters' dating status, mothers' history of HPV, mother/daughter discussion of sex topics, or the general family environment.
"Although the study was not designed to examine the process of and impact of physician counseling, it appeared that those who had been counseled had more positive attitudes toward the vaccine and understood better the reasons for vaccinating their daughters prior to initiation of sexual activity," the researchers noted.
The study was limited by the relatively small sample and by the university setting, which might have provided more education to parents and daughters than would other settings. But the results suggest that even those parents and daughters who were counseled about the HPV vaccine wanted more information, and further studies are needed to determine the most effective ways to provide more education, the researchers wrote.
Many mothers who were not planning to vaccinate their daughters within the next year planned to vaccinate them eventually, they added.
The study was funded by grants from Merck & Co. and the National Institutes of Health.
Safety, not sexuality, was a key factor in the reluctance of mothers to have their teenage daughters vaccinated against human papillomavirus, according to results from a study published in the Journal of Adolescent Health.
The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices currently recommends a three-dose vaccine against the human papillomavirus (HPV) for all girls aged 1112 years and young women aged 1326 years. HPV has been identified as a leading cause of cervical cancer.
Previous studies have shown that parents were in favor of vaccination for adolescents but hesitant to vaccinate younger girls. In most cases, though, this resistance was not brought on by concerns that the vaccination might make teenage girls more likely to engage in risky sexual activities.
To examine the factors that influence parents' acceptance of the HPV vaccine, Susan L. Rosenthal, Ph.D., of the University of Texas Medical Branch in Galveston, Tex., and her colleagues interviewed mothers with daughters aged 1117 years who were visitors to a university-based primary care clinic.
The study included complete results from 153 mothers of various ethnicities (average age 41 years) who completed a questionnaire. The questionnaire included ratings of seven health beliefs including perceptions of HPV disease severity and barriers to vaccination, such as cost. The questionnaire also addressed aspects of the parent/child relationship, including how closely the girls' activities were monitored by parents and whether the parents had discussed topics such as birth control, dating, and making decisions about sex (J. Adolesc. Health 2008;43:23945).
Overall, 18% (27) of the mothers had been offered the HPV vaccination for their daughters but had not chosen it, and did not plan to vaccinate their daughters within the next year, while 34% (52) had not been offered the vaccination and did not plan to vaccinate their daughters within the next year. Another 22% (34) had not been offered the vaccine but were aware of it and planned to vaccinate their daughters within the next year, and 26% (40) of the mothers reported that their daughters had started or completed the vaccination series.
None of the mothers whose daughters had been vaccinated said they viewed the vaccine as unsafe, but objections to the vaccine were focused mostly on the lack of safety data because of the newness of the vaccine. Mothers who were offered the vaccine but did not plan to vaccinate their daughters within the year often cited a lack information about the vaccine, and some cited a lack of urgency based on their perceptions of their daughters' likely exposure to HPV.
Significant predictors of HPV vaccination after a multivariate analysis were mothers who had less than a high school education, had a history of sexually transmitted infections, had monitored their daughters' activities with peers, and had thought their daughters would not mind getting the shots.
There was no significant association between HPV vaccine acceptance and the ages and ethnicities of the mothers and daughters, the daughters' dating status, mothers' history of HPV, mother/daughter discussion of sex topics, or the general family environment.
"Although the study was not designed to examine the process of and impact of physician counseling, it appeared that those who had been counseled had more positive attitudes toward the vaccine and understood better the reasons for vaccinating their daughters prior to initiation of sexual activity," the researchers noted.
The study was limited by the relatively small sample and by the university setting, which might have provided more education to parents and daughters than would other settings. But the results suggest that even those parents and daughters who were counseled about the HPV vaccine wanted more information, and further studies are needed to determine the most effective ways to provide more education, the researchers wrote.
Many mothers who were not planning to vaccinate their daughters within the next year planned to vaccinate them eventually, they added.
The study was funded by grants from Merck & Co. and the National Institutes of Health.
Safety, not sexuality, was a key factor in the reluctance of mothers to have their teenage daughters vaccinated against human papillomavirus, according to results from a study published in the Journal of Adolescent Health.
The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices currently recommends a three-dose vaccine against the human papillomavirus (HPV) for all girls aged 1112 years and young women aged 1326 years. HPV has been identified as a leading cause of cervical cancer.
Previous studies have shown that parents were in favor of vaccination for adolescents but hesitant to vaccinate younger girls. In most cases, though, this resistance was not brought on by concerns that the vaccination might make teenage girls more likely to engage in risky sexual activities.
To examine the factors that influence parents' acceptance of the HPV vaccine, Susan L. Rosenthal, Ph.D., of the University of Texas Medical Branch in Galveston, Tex., and her colleagues interviewed mothers with daughters aged 1117 years who were visitors to a university-based primary care clinic.
The study included complete results from 153 mothers of various ethnicities (average age 41 years) who completed a questionnaire. The questionnaire included ratings of seven health beliefs including perceptions of HPV disease severity and barriers to vaccination, such as cost. The questionnaire also addressed aspects of the parent/child relationship, including how closely the girls' activities were monitored by parents and whether the parents had discussed topics such as birth control, dating, and making decisions about sex (J. Adolesc. Health 2008;43:23945).
Overall, 18% (27) of the mothers had been offered the HPV vaccination for their daughters but had not chosen it, and did not plan to vaccinate their daughters within the next year, while 34% (52) had not been offered the vaccination and did not plan to vaccinate their daughters within the next year. Another 22% (34) had not been offered the vaccine but were aware of it and planned to vaccinate their daughters within the next year, and 26% (40) of the mothers reported that their daughters had started or completed the vaccination series.
None of the mothers whose daughters had been vaccinated said they viewed the vaccine as unsafe, but objections to the vaccine were focused mostly on the lack of safety data because of the newness of the vaccine. Mothers who were offered the vaccine but did not plan to vaccinate their daughters within the year often cited a lack information about the vaccine, and some cited a lack of urgency based on their perceptions of their daughters' likely exposure to HPV.
Significant predictors of HPV vaccination after a multivariate analysis were mothers who had less than a high school education, had a history of sexually transmitted infections, had monitored their daughters' activities with peers, and had thought their daughters would not mind getting the shots.
There was no significant association between HPV vaccine acceptance and the ages and ethnicities of the mothers and daughters, the daughters' dating status, mothers' history of HPV, mother/daughter discussion of sex topics, or the general family environment.
"Although the study was not designed to examine the process of and impact of physician counseling, it appeared that those who had been counseled had more positive attitudes toward the vaccine and understood better the reasons for vaccinating their daughters prior to initiation of sexual activity," the researchers noted.
The study was limited by the relatively small sample and by the university setting, which might have provided more education to parents and daughters than would other settings. But the results suggest that even those parents and daughters who were counseled about the HPV vaccine wanted more information, and further studies are needed to determine the most effective ways to provide more education, the researchers wrote.
Many mothers who were not planning to vaccinate their daughters within the next year planned to vaccinate them eventually, they added.
The study was funded by grants from Merck & Co. and the National Institutes of Health.
Safety Tops Parents' Concerns on HPV Vaccine
Safety, not sexuality, was a key factor in the reluctance of mothers to have their teenage daughters vaccinated against human papillomavirus, according to results from a study published in the Journal of Adolescent Health.
The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices currently recommends a three-dose vaccine against the human papillomavirus (HPV) for all girls aged 11–12 years and young women aged 13–26 years. HPV has been identified as a leading cause of cervical cancer.
Previous studies have shown that parents were in favor of vaccination for adolescents but hesitant to vaccinate younger girls. But data from these studies have shown that in most cases, this resistance was not brought on by concerns that the vaccination might make teenage girls more likely to engage in risky sexual activities.
To examine the factors that influence parents' acceptance of the HPV vaccine, Susan L. Rosenthal, Ph.D., of the University of Texas Medical Branch in Galveston, Tex., and her colleagues interviewed mothers with daughters aged 11–17 years who were visitors to a university-based primary care clinic.
The study included complete results from 153 mothers of various ethnicities (average age 41 years) who completed a questionnaire. The questionnaire included ratings of seven health beliefs including perceptions of HPV disease severity and barriers to vaccination, such as cost.
The questionnaire also addressed aspects of the parent/child relationship, including how closely the girls' activities were monitored by parents and whether the parents had discussed topics such as birth control, dating, and making decisions about sex (J. Adolesc. Health 2008;43:239–45).
Overall, 18% (27) of the mothers had been offered the HPV vaccination for their daughters but had not chosen it, and did not plan to vaccinate their daughters within the next year, while 34% (52) had not been offered the vaccination and did not plan to vaccinate their daughters within the next year. Another 22% (34) had not been offered the vaccine but were aware of it and planned to vaccinate their daughters within the next year, and 26% (40) of the mothers reported that their daughters had started or completed the vaccination series.
None of the mothers whose daughters had been vaccinated said they viewed the vaccine as unsafe, but objections to the vaccine were focused mostly on the lack of safety data because of the newness of the vaccine. Mothers who were offered the vaccine but did not plan to vaccinate their daughters within the year often cited a lack information about the vaccine, and some cited a lack of urgency based on their perceptions of their daughters' likely exposure to HPV.
Significant predictors of HPV vaccination after a multivariate analysis were mothers who had less than a high school education, had a history of sexually transmitted infections, had monitored their daughters' activities with peers, and had thought their daughters would not mind getting the shots.
There was no significant association between HPV vaccine acceptance and the ages and ethnicities of the mothers and daughters, the daughters' dating status, mothers' history of HPV, mother/daughter discussion of sex topics, or the general family environment.
“Although the study was not designed to examine the process of and impact of physician counseling, it appeared that those who had been counseled had more positive attitudes toward the vaccine and understood better the reasons for vaccinating their daughters prior to initiation of sexual activity,” the researchers noted.
The study was funded by grants from Merck & Co. and the National Institutes of Health.
Safety, not sexuality, was a key factor in the reluctance of mothers to have their teenage daughters vaccinated against human papillomavirus, according to results from a study published in the Journal of Adolescent Health.
The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices currently recommends a three-dose vaccine against the human papillomavirus (HPV) for all girls aged 11–12 years and young women aged 13–26 years. HPV has been identified as a leading cause of cervical cancer.
Previous studies have shown that parents were in favor of vaccination for adolescents but hesitant to vaccinate younger girls. But data from these studies have shown that in most cases, this resistance was not brought on by concerns that the vaccination might make teenage girls more likely to engage in risky sexual activities.
To examine the factors that influence parents' acceptance of the HPV vaccine, Susan L. Rosenthal, Ph.D., of the University of Texas Medical Branch in Galveston, Tex., and her colleagues interviewed mothers with daughters aged 11–17 years who were visitors to a university-based primary care clinic.
The study included complete results from 153 mothers of various ethnicities (average age 41 years) who completed a questionnaire. The questionnaire included ratings of seven health beliefs including perceptions of HPV disease severity and barriers to vaccination, such as cost.
The questionnaire also addressed aspects of the parent/child relationship, including how closely the girls' activities were monitored by parents and whether the parents had discussed topics such as birth control, dating, and making decisions about sex (J. Adolesc. Health 2008;43:239–45).
Overall, 18% (27) of the mothers had been offered the HPV vaccination for their daughters but had not chosen it, and did not plan to vaccinate their daughters within the next year, while 34% (52) had not been offered the vaccination and did not plan to vaccinate their daughters within the next year. Another 22% (34) had not been offered the vaccine but were aware of it and planned to vaccinate their daughters within the next year, and 26% (40) of the mothers reported that their daughters had started or completed the vaccination series.
None of the mothers whose daughters had been vaccinated said they viewed the vaccine as unsafe, but objections to the vaccine were focused mostly on the lack of safety data because of the newness of the vaccine. Mothers who were offered the vaccine but did not plan to vaccinate their daughters within the year often cited a lack information about the vaccine, and some cited a lack of urgency based on their perceptions of their daughters' likely exposure to HPV.
Significant predictors of HPV vaccination after a multivariate analysis were mothers who had less than a high school education, had a history of sexually transmitted infections, had monitored their daughters' activities with peers, and had thought their daughters would not mind getting the shots.
There was no significant association between HPV vaccine acceptance and the ages and ethnicities of the mothers and daughters, the daughters' dating status, mothers' history of HPV, mother/daughter discussion of sex topics, or the general family environment.
“Although the study was not designed to examine the process of and impact of physician counseling, it appeared that those who had been counseled had more positive attitudes toward the vaccine and understood better the reasons for vaccinating their daughters prior to initiation of sexual activity,” the researchers noted.
The study was funded by grants from Merck & Co. and the National Institutes of Health.
Safety, not sexuality, was a key factor in the reluctance of mothers to have their teenage daughters vaccinated against human papillomavirus, according to results from a study published in the Journal of Adolescent Health.
The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices currently recommends a three-dose vaccine against the human papillomavirus (HPV) for all girls aged 11–12 years and young women aged 13–26 years. HPV has been identified as a leading cause of cervical cancer.
Previous studies have shown that parents were in favor of vaccination for adolescents but hesitant to vaccinate younger girls. But data from these studies have shown that in most cases, this resistance was not brought on by concerns that the vaccination might make teenage girls more likely to engage in risky sexual activities.
To examine the factors that influence parents' acceptance of the HPV vaccine, Susan L. Rosenthal, Ph.D., of the University of Texas Medical Branch in Galveston, Tex., and her colleagues interviewed mothers with daughters aged 11–17 years who were visitors to a university-based primary care clinic.
The study included complete results from 153 mothers of various ethnicities (average age 41 years) who completed a questionnaire. The questionnaire included ratings of seven health beliefs including perceptions of HPV disease severity and barriers to vaccination, such as cost.
The questionnaire also addressed aspects of the parent/child relationship, including how closely the girls' activities were monitored by parents and whether the parents had discussed topics such as birth control, dating, and making decisions about sex (J. Adolesc. Health 2008;43:239–45).
Overall, 18% (27) of the mothers had been offered the HPV vaccination for their daughters but had not chosen it, and did not plan to vaccinate their daughters within the next year, while 34% (52) had not been offered the vaccination and did not plan to vaccinate their daughters within the next year. Another 22% (34) had not been offered the vaccine but were aware of it and planned to vaccinate their daughters within the next year, and 26% (40) of the mothers reported that their daughters had started or completed the vaccination series.
None of the mothers whose daughters had been vaccinated said they viewed the vaccine as unsafe, but objections to the vaccine were focused mostly on the lack of safety data because of the newness of the vaccine. Mothers who were offered the vaccine but did not plan to vaccinate their daughters within the year often cited a lack information about the vaccine, and some cited a lack of urgency based on their perceptions of their daughters' likely exposure to HPV.
Significant predictors of HPV vaccination after a multivariate analysis were mothers who had less than a high school education, had a history of sexually transmitted infections, had monitored their daughters' activities with peers, and had thought their daughters would not mind getting the shots.
There was no significant association between HPV vaccine acceptance and the ages and ethnicities of the mothers and daughters, the daughters' dating status, mothers' history of HPV, mother/daughter discussion of sex topics, or the general family environment.
“Although the study was not designed to examine the process of and impact of physician counseling, it appeared that those who had been counseled had more positive attitudes toward the vaccine and understood better the reasons for vaccinating their daughters prior to initiation of sexual activity,” the researchers noted.
The study was funded by grants from Merck & Co. and the National Institutes of Health.
Don't Miss Myocardial Infarction in Pregnancy
Overall, acute myocardial infarction remains rare in women of childbearing age, but the prevalence is expected to rise as more women postpone pregnancy, according to a review of 103 women who had acute myocardial infarctions during pregnancy.
Coronary dissection was the cause of AMI in more than a quarter of the cases. A total of 28 patients (27%) had 41 dissected coronary arteries, even though this condition is rare as a cause of AMI in nonpregnant patients, according to the investigators, Dr. Arie Roth of Tel Aviv University and Dr. Uri Elkayam of the University of Southern California, Los Angeles.
“The coronary dissection is unique to pregnancy,” Dr. Elkayam said. “That means when a pregnant woman has acute MI, the clinician has to consider that many [of these women] would not have the usual atherosclerotic disease.”
It's important to define the nature of the MI by angiography before deciding on an aggressive therapy, and to avoid the automatic use of thrombolytic therapy, he said.
“Most physicians don't see patients like this or they see one in their lifetime, and it is difficult to know what to do, and so the patients may not get the appropriate care,” Dr. Elkayam said.
The physicians conducted this review of cases between 1995 and 2005 to update characteristics of AMIs during pregnancy from their 1995 analysis of 125 women who had AMIs during pregnancy between 1922 and 1995.
In the current review, the women's ages ranged from 19 to 44 years, but 72% were older than 30 years. The average age for women in both study groups was 33 years (J. Am. Coll. Cardiol. 2008;52:171–80).
“The diagnostic and therapeutic changes have been revolutionary,” Dr. Elkayam noted. For example, data on the coronary anatomy were available for only 54% of the early group, compared with 93% of the current group, a statistically significant difference.
Consequently, the approach is more aggressive in terms of performing angiography and angioplasty and placing stents in young women, said Dr. Elkayam, director of the heart failure program and a professor of ob.gyn. and medicine at the University of Southern California, Los Angeles.
Advances in technology helped to reduce the mortality rate from 21% in the earlier review to 11% in the current review. Although this difference was not statistically significant, it supports findings of reduced mortality rates from other studies and suggests “a significant improvement in the outcome of pregnancy-related AMI in the last decade,” the investigators noted.
The fetal mortality rate in the current study group was 9%, and two pregnancies were terminated because of concerns about drug teratogenicity.
Despite the relatively young ages of the women studied, risk factors for AMI were fairly common. Overall, 45% of the women were smokers, 24% had hyperlipidemia, 22% had family history of MI, 15% had high blood pressure, and 11% had diabetes.
“The incidence of MI in pregnancy is very low, but it was surprising that the risk factors were high,” noted Dr. Elkayam. Many younger women may not recognize risk factors such as a family history of MI or receive treatment for risk factors such as high cholesterol, or high blood pressure prior to pregnancy, he said.
Treating MI risk factors in pregnant women remains a challenge because the drugs that clinicians use are potentially risky to the mother, fetus, or both.
“Pregnant women are always excluded from trials,” Dr. Elkayam said. “So we are somewhat limited and we must consider true benefit vs. potential risk.”
Because physicians are treating two patients—mother and fetus—they need to make medication decisions wisely. “Sometimes we may have to use the therapy if the patient is at high risk,” he said.
It is difficult to conduct research with pregnant women, Dr. Elkayam acknowledged. But physicians must continue to report data from cases of acute MI in pregnancy in order to build a knowledge base to help manage these patients.
“We need to continue to follow these patients and perhaps start a registry so we can increase our understanding. For example, there are no data on the use of drug-eluting stents in pregnant women.”
Several techniques for evaluating possible AMI in nonpregnant patients are safe for pregnant women, with modifications as necessary based on concerns for fetal safety and factors associated with normal pregnancy. Safe choices include an echocardiogram and exercise testing, but radiation exposure should be limited, the investigators noted.
AMI in pregnant women is often overlooked or dismissed as reflux or indigestion, which can lead to a delay in diagnosis, Dr. Carole Warnes, a cardiologist at the Mayo Clinic, Rochester, Minn., said in an interview.
“AMI must be recognized by emergency physicians and internists as well as ob.gyns,” she said, and patients should be referred to a cardiologist promptly if AMI is suspected.
Consider AMI in any symptomatic pregnant patient with a suggestive history and rule it out only after a detailed cardiac evaluation, Dr. Warnes advised.
If AMI is diagnosed, “manage the patient, preferably in an ICU where combined cardiac and obstetric care can be provided with a multidisciplinary team approach,” she said.
Risk Categories for Therapy Options For Treating AMI in Pregnant Women
Drug therapies that were noted in the review fit into the Food and Drug Administration's pregnancy risk categories as follows:
Risk Category B (Drug has shown no risk to the fetus based on animal studies, or animal studies showed a risk that was not confirmed by controlled studies of women in the first trimester of pregnancy.)
▸ Organic nitrates: nitroglycerine.
▸ β-Adrenergic blocking agents: metoprolol.
▸ Aldosterone blocker: eplerenone.
▸ Low-molecular-weight heparin.
▸ Antiplatelet therapy: thienopyridine derivatives (clopidogrel, ticlopidine), glycoprotein IIb/IIIa inhibitors (eptifibatide, tirofiban).
Risk Category C (Drug poses potential risk to the fetus and should only be given if the potential benefit justifies potential risk.)
▸ Organic nitrates: isosorbide dinitrate.
▸ β-Adrenergic blocking agents: atenolol.
▸ Calcium channel blockers: nifedipine, diltiazem, verapamil.
▸ Unfractionated heparin.
▸ Antiplatelet therapy: aspirin, glycoprotein IIB/IIIa inhibitors (abciximab).
▸ Angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor antagonists (ARBs). Contraindicated for pregnant patients.
▸ Morphine sulfate: One study of 448 exposures showed no evidence of teratogenic effects.
Risk Category X (Drug has shown evidence of causing fetal abnormalities and the risk to the fetus outweighs any possible benefit).
▸ HMG-CoA Reductase Inhibitors (statins): Use of these drugs is not recommended in pregnancy because of evidence of inhibition of DNA replication and of fetal abnormalities in animal studies.
Source: J. Am. Coll. Cardiol. 2008;52:171–80
Overall, acute myocardial infarction remains rare in women of childbearing age, but the prevalence is expected to rise as more women postpone pregnancy, according to a review of 103 women who had acute myocardial infarctions during pregnancy.
Coronary dissection was the cause of AMI in more than a quarter of the cases. A total of 28 patients (27%) had 41 dissected coronary arteries, even though this condition is rare as a cause of AMI in nonpregnant patients, according to the investigators, Dr. Arie Roth of Tel Aviv University and Dr. Uri Elkayam of the University of Southern California, Los Angeles.
“The coronary dissection is unique to pregnancy,” Dr. Elkayam said. “That means when a pregnant woman has acute MI, the clinician has to consider that many [of these women] would not have the usual atherosclerotic disease.”
It's important to define the nature of the MI by angiography before deciding on an aggressive therapy, and to avoid the automatic use of thrombolytic therapy, he said.
“Most physicians don't see patients like this or they see one in their lifetime, and it is difficult to know what to do, and so the patients may not get the appropriate care,” Dr. Elkayam said.
The physicians conducted this review of cases between 1995 and 2005 to update characteristics of AMIs during pregnancy from their 1995 analysis of 125 women who had AMIs during pregnancy between 1922 and 1995.
In the current review, the women's ages ranged from 19 to 44 years, but 72% were older than 30 years. The average age for women in both study groups was 33 years (J. Am. Coll. Cardiol. 2008;52:171–80).
“The diagnostic and therapeutic changes have been revolutionary,” Dr. Elkayam noted. For example, data on the coronary anatomy were available for only 54% of the early group, compared with 93% of the current group, a statistically significant difference.
Consequently, the approach is more aggressive in terms of performing angiography and angioplasty and placing stents in young women, said Dr. Elkayam, director of the heart failure program and a professor of ob.gyn. and medicine at the University of Southern California, Los Angeles.
Advances in technology helped to reduce the mortality rate from 21% in the earlier review to 11% in the current review. Although this difference was not statistically significant, it supports findings of reduced mortality rates from other studies and suggests “a significant improvement in the outcome of pregnancy-related AMI in the last decade,” the investigators noted.
The fetal mortality rate in the current study group was 9%, and two pregnancies were terminated because of concerns about drug teratogenicity.
Despite the relatively young ages of the women studied, risk factors for AMI were fairly common. Overall, 45% of the women were smokers, 24% had hyperlipidemia, 22% had family history of MI, 15% had high blood pressure, and 11% had diabetes.
“The incidence of MI in pregnancy is very low, but it was surprising that the risk factors were high,” noted Dr. Elkayam. Many younger women may not recognize risk factors such as a family history of MI or receive treatment for risk factors such as high cholesterol, or high blood pressure prior to pregnancy, he said.
Treating MI risk factors in pregnant women remains a challenge because the drugs that clinicians use are potentially risky to the mother, fetus, or both.
“Pregnant women are always excluded from trials,” Dr. Elkayam said. “So we are somewhat limited and we must consider true benefit vs. potential risk.”
Because physicians are treating two patients—mother and fetus—they need to make medication decisions wisely. “Sometimes we may have to use the therapy if the patient is at high risk,” he said.
It is difficult to conduct research with pregnant women, Dr. Elkayam acknowledged. But physicians must continue to report data from cases of acute MI in pregnancy in order to build a knowledge base to help manage these patients.
“We need to continue to follow these patients and perhaps start a registry so we can increase our understanding. For example, there are no data on the use of drug-eluting stents in pregnant women.”
Several techniques for evaluating possible AMI in nonpregnant patients are safe for pregnant women, with modifications as necessary based on concerns for fetal safety and factors associated with normal pregnancy. Safe choices include an echocardiogram and exercise testing, but radiation exposure should be limited, the investigators noted.
AMI in pregnant women is often overlooked or dismissed as reflux or indigestion, which can lead to a delay in diagnosis, Dr. Carole Warnes, a cardiologist at the Mayo Clinic, Rochester, Minn., said in an interview.
“AMI must be recognized by emergency physicians and internists as well as ob.gyns,” she said, and patients should be referred to a cardiologist promptly if AMI is suspected.
Consider AMI in any symptomatic pregnant patient with a suggestive history and rule it out only after a detailed cardiac evaluation, Dr. Warnes advised.
If AMI is diagnosed, “manage the patient, preferably in an ICU where combined cardiac and obstetric care can be provided with a multidisciplinary team approach,” she said.
Risk Categories for Therapy Options For Treating AMI in Pregnant Women
Drug therapies that were noted in the review fit into the Food and Drug Administration's pregnancy risk categories as follows:
Risk Category B (Drug has shown no risk to the fetus based on animal studies, or animal studies showed a risk that was not confirmed by controlled studies of women in the first trimester of pregnancy.)
▸ Organic nitrates: nitroglycerine.
▸ β-Adrenergic blocking agents: metoprolol.
▸ Aldosterone blocker: eplerenone.
▸ Low-molecular-weight heparin.
▸ Antiplatelet therapy: thienopyridine derivatives (clopidogrel, ticlopidine), glycoprotein IIb/IIIa inhibitors (eptifibatide, tirofiban).
Risk Category C (Drug poses potential risk to the fetus and should only be given if the potential benefit justifies potential risk.)
▸ Organic nitrates: isosorbide dinitrate.
▸ β-Adrenergic blocking agents: atenolol.
▸ Calcium channel blockers: nifedipine, diltiazem, verapamil.
▸ Unfractionated heparin.
▸ Antiplatelet therapy: aspirin, glycoprotein IIB/IIIa inhibitors (abciximab).
▸ Angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor antagonists (ARBs). Contraindicated for pregnant patients.
▸ Morphine sulfate: One study of 448 exposures showed no evidence of teratogenic effects.
Risk Category X (Drug has shown evidence of causing fetal abnormalities and the risk to the fetus outweighs any possible benefit).
▸ HMG-CoA Reductase Inhibitors (statins): Use of these drugs is not recommended in pregnancy because of evidence of inhibition of DNA replication and of fetal abnormalities in animal studies.
Source: J. Am. Coll. Cardiol. 2008;52:171–80
Overall, acute myocardial infarction remains rare in women of childbearing age, but the prevalence is expected to rise as more women postpone pregnancy, according to a review of 103 women who had acute myocardial infarctions during pregnancy.
Coronary dissection was the cause of AMI in more than a quarter of the cases. A total of 28 patients (27%) had 41 dissected coronary arteries, even though this condition is rare as a cause of AMI in nonpregnant patients, according to the investigators, Dr. Arie Roth of Tel Aviv University and Dr. Uri Elkayam of the University of Southern California, Los Angeles.
“The coronary dissection is unique to pregnancy,” Dr. Elkayam said. “That means when a pregnant woman has acute MI, the clinician has to consider that many [of these women] would not have the usual atherosclerotic disease.”
It's important to define the nature of the MI by angiography before deciding on an aggressive therapy, and to avoid the automatic use of thrombolytic therapy, he said.
“Most physicians don't see patients like this or they see one in their lifetime, and it is difficult to know what to do, and so the patients may not get the appropriate care,” Dr. Elkayam said.
The physicians conducted this review of cases between 1995 and 2005 to update characteristics of AMIs during pregnancy from their 1995 analysis of 125 women who had AMIs during pregnancy between 1922 and 1995.
In the current review, the women's ages ranged from 19 to 44 years, but 72% were older than 30 years. The average age for women in both study groups was 33 years (J. Am. Coll. Cardiol. 2008;52:171–80).
“The diagnostic and therapeutic changes have been revolutionary,” Dr. Elkayam noted. For example, data on the coronary anatomy were available for only 54% of the early group, compared with 93% of the current group, a statistically significant difference.
Consequently, the approach is more aggressive in terms of performing angiography and angioplasty and placing stents in young women, said Dr. Elkayam, director of the heart failure program and a professor of ob.gyn. and medicine at the University of Southern California, Los Angeles.
Advances in technology helped to reduce the mortality rate from 21% in the earlier review to 11% in the current review. Although this difference was not statistically significant, it supports findings of reduced mortality rates from other studies and suggests “a significant improvement in the outcome of pregnancy-related AMI in the last decade,” the investigators noted.
The fetal mortality rate in the current study group was 9%, and two pregnancies were terminated because of concerns about drug teratogenicity.
Despite the relatively young ages of the women studied, risk factors for AMI were fairly common. Overall, 45% of the women were smokers, 24% had hyperlipidemia, 22% had family history of MI, 15% had high blood pressure, and 11% had diabetes.
“The incidence of MI in pregnancy is very low, but it was surprising that the risk factors were high,” noted Dr. Elkayam. Many younger women may not recognize risk factors such as a family history of MI or receive treatment for risk factors such as high cholesterol, or high blood pressure prior to pregnancy, he said.
Treating MI risk factors in pregnant women remains a challenge because the drugs that clinicians use are potentially risky to the mother, fetus, or both.
“Pregnant women are always excluded from trials,” Dr. Elkayam said. “So we are somewhat limited and we must consider true benefit vs. potential risk.”
Because physicians are treating two patients—mother and fetus—they need to make medication decisions wisely. “Sometimes we may have to use the therapy if the patient is at high risk,” he said.
It is difficult to conduct research with pregnant women, Dr. Elkayam acknowledged. But physicians must continue to report data from cases of acute MI in pregnancy in order to build a knowledge base to help manage these patients.
“We need to continue to follow these patients and perhaps start a registry so we can increase our understanding. For example, there are no data on the use of drug-eluting stents in pregnant women.”
Several techniques for evaluating possible AMI in nonpregnant patients are safe for pregnant women, with modifications as necessary based on concerns for fetal safety and factors associated with normal pregnancy. Safe choices include an echocardiogram and exercise testing, but radiation exposure should be limited, the investigators noted.
AMI in pregnant women is often overlooked or dismissed as reflux or indigestion, which can lead to a delay in diagnosis, Dr. Carole Warnes, a cardiologist at the Mayo Clinic, Rochester, Minn., said in an interview.
“AMI must be recognized by emergency physicians and internists as well as ob.gyns,” she said, and patients should be referred to a cardiologist promptly if AMI is suspected.
Consider AMI in any symptomatic pregnant patient with a suggestive history and rule it out only after a detailed cardiac evaluation, Dr. Warnes advised.
If AMI is diagnosed, “manage the patient, preferably in an ICU where combined cardiac and obstetric care can be provided with a multidisciplinary team approach,” she said.
Risk Categories for Therapy Options For Treating AMI in Pregnant Women
Drug therapies that were noted in the review fit into the Food and Drug Administration's pregnancy risk categories as follows:
Risk Category B (Drug has shown no risk to the fetus based on animal studies, or animal studies showed a risk that was not confirmed by controlled studies of women in the first trimester of pregnancy.)
▸ Organic nitrates: nitroglycerine.
▸ β-Adrenergic blocking agents: metoprolol.
▸ Aldosterone blocker: eplerenone.
▸ Low-molecular-weight heparin.
▸ Antiplatelet therapy: thienopyridine derivatives (clopidogrel, ticlopidine), glycoprotein IIb/IIIa inhibitors (eptifibatide, tirofiban).
Risk Category C (Drug poses potential risk to the fetus and should only be given if the potential benefit justifies potential risk.)
▸ Organic nitrates: isosorbide dinitrate.
▸ β-Adrenergic blocking agents: atenolol.
▸ Calcium channel blockers: nifedipine, diltiazem, verapamil.
▸ Unfractionated heparin.
▸ Antiplatelet therapy: aspirin, glycoprotein IIB/IIIa inhibitors (abciximab).
▸ Angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor antagonists (ARBs). Contraindicated for pregnant patients.
▸ Morphine sulfate: One study of 448 exposures showed no evidence of teratogenic effects.
Risk Category X (Drug has shown evidence of causing fetal abnormalities and the risk to the fetus outweighs any possible benefit).
▸ HMG-CoA Reductase Inhibitors (statins): Use of these drugs is not recommended in pregnancy because of evidence of inhibition of DNA replication and of fetal abnormalities in animal studies.
Source: J. Am. Coll. Cardiol. 2008;52:171–80
Cardiac Devices Pose Tough Choices for the Elderly
WASHINGTON — Pacemakers and implantable cardioverter defibrillators can extend survival and improve functionality in properly selected cardiac patients, but given the lack of data from elderly individuals, choices can be complex and challenging.
“We don't have very good long-term randomized, prospective clinical trials in the very elderly to know exactly what the best therapy is,” Dr. Brian Olshansky said at the annual meeting of the Society of Geriatric Cardiology.
“Not everyone is going to be saved with an implantable cardioverter defibrillator [ICD],” said Dr. Olshansky, a professor of medicine and a cardiac electrophysiologist at the University of Iowa, Iowa City.
But device therapy can be beneficial in elderly patients with tachyarrhythmias or bradyarrhythmias because these conditions can significantly impair the patient's daily activities, he noted.
On the basis of results from a recent review of a Medicare database, “what we can say is that people who receive ICDs [whether single chamber, dual chamber, or with cardiac resynchronization pacing], presumably for the right reason, do better than those who don't in a Medicare population,” Dr. Olshansky said (Heart Rhythm 2008;5:646–53).
However, the benefit of pacemakers in this population is less clear. In the Pacemaker Selection in the Elderly (PASE) study, a single-blind, prospective, randomized trial that examined quality of life after pacemaker implantation in patients with a mean age of 76 years, use of a pacemaker significantly improved quality of life in patients with symptomatic bradycardia, but there was no difference in survival between dual- and single-chamber pacemakers, said Dr. Olshansky (N. Engl. J. Med. 1998;338:1097–104).
In some cases a pacemaker is only part of the solution in lieu of medications or procedures to treat tachyarrhythmias such as atrial fibrillation. Atrioventricular (AV) junction ablation can be an effective means of controlling fast ventricular rates caused by atrial fibrillation, improving quality of life and functionality.
“In my experience, elderly patients seem to get a tremendous benefit from AV junctional ablation in cases with fast rates in atrial fibrillation not controlled with medical therapy,” Dr. Olshansky said.
“What is really most important is that an AV junctional ablation can allow patients to do what they want to do, like carrying groceries and climbing stairs,” said Dr. Olshansky.
Cardiac resynchronization therapy (CRT) for patients with impaired ventricular function, functional class III or IV heart failure, and a wide QRS complex may be an appropriate option, but it has not been well studied in patients older than 80 years, and it is more complicated and expensive than a single-site option, he noted.
But potential benefits of CRT include improved quality of life, as well as reduced heart failure symptoms and improved exercise tolerance. Also, studies have shown that CRT can reduce hospitalization and the risk of death.
The Multicenter InSync Randomized Clinical Evaluation (MIRACLE) study, which included patients approximately 65 years old, significantly improved functional status over a 6-month follow-up period after CRT pacing, compared with a control group who received a CRT implant without pacing (N. Engl. J. Med. 2002;346:1845–53).
Another growing area is atrial fibrillation ablation, but older patients are at greater risk from this long, arduous procedure and they may derive less benefit, compared with a younger population. Although study findings suggest that this procedure may improve quality of life more than antiarrhythmic medications, these data do not include elderly patients.
Dr. Olshansky stated that he has served as a consultant and a member of the speakers bureaus for Medtronic, Boston Scientific, and Novartis.
Device therapy can be beneficial in elderlypatients with tachyarrhythmias or bradyarrhythmias. DR. OLSHANSKY
WASHINGTON — Pacemakers and implantable cardioverter defibrillators can extend survival and improve functionality in properly selected cardiac patients, but given the lack of data from elderly individuals, choices can be complex and challenging.
“We don't have very good long-term randomized, prospective clinical trials in the very elderly to know exactly what the best therapy is,” Dr. Brian Olshansky said at the annual meeting of the Society of Geriatric Cardiology.
“Not everyone is going to be saved with an implantable cardioverter defibrillator [ICD],” said Dr. Olshansky, a professor of medicine and a cardiac electrophysiologist at the University of Iowa, Iowa City.
But device therapy can be beneficial in elderly patients with tachyarrhythmias or bradyarrhythmias because these conditions can significantly impair the patient's daily activities, he noted.
On the basis of results from a recent review of a Medicare database, “what we can say is that people who receive ICDs [whether single chamber, dual chamber, or with cardiac resynchronization pacing], presumably for the right reason, do better than those who don't in a Medicare population,” Dr. Olshansky said (Heart Rhythm 2008;5:646–53).
However, the benefit of pacemakers in this population is less clear. In the Pacemaker Selection in the Elderly (PASE) study, a single-blind, prospective, randomized trial that examined quality of life after pacemaker implantation in patients with a mean age of 76 years, use of a pacemaker significantly improved quality of life in patients with symptomatic bradycardia, but there was no difference in survival between dual- and single-chamber pacemakers, said Dr. Olshansky (N. Engl. J. Med. 1998;338:1097–104).
In some cases a pacemaker is only part of the solution in lieu of medications or procedures to treat tachyarrhythmias such as atrial fibrillation. Atrioventricular (AV) junction ablation can be an effective means of controlling fast ventricular rates caused by atrial fibrillation, improving quality of life and functionality.
“In my experience, elderly patients seem to get a tremendous benefit from AV junctional ablation in cases with fast rates in atrial fibrillation not controlled with medical therapy,” Dr. Olshansky said.
“What is really most important is that an AV junctional ablation can allow patients to do what they want to do, like carrying groceries and climbing stairs,” said Dr. Olshansky.
Cardiac resynchronization therapy (CRT) for patients with impaired ventricular function, functional class III or IV heart failure, and a wide QRS complex may be an appropriate option, but it has not been well studied in patients older than 80 years, and it is more complicated and expensive than a single-site option, he noted.
But potential benefits of CRT include improved quality of life, as well as reduced heart failure symptoms and improved exercise tolerance. Also, studies have shown that CRT can reduce hospitalization and the risk of death.
The Multicenter InSync Randomized Clinical Evaluation (MIRACLE) study, which included patients approximately 65 years old, significantly improved functional status over a 6-month follow-up period after CRT pacing, compared with a control group who received a CRT implant without pacing (N. Engl. J. Med. 2002;346:1845–53).
Another growing area is atrial fibrillation ablation, but older patients are at greater risk from this long, arduous procedure and they may derive less benefit, compared with a younger population. Although study findings suggest that this procedure may improve quality of life more than antiarrhythmic medications, these data do not include elderly patients.
Dr. Olshansky stated that he has served as a consultant and a member of the speakers bureaus for Medtronic, Boston Scientific, and Novartis.
Device therapy can be beneficial in elderlypatients with tachyarrhythmias or bradyarrhythmias. DR. OLSHANSKY
WASHINGTON — Pacemakers and implantable cardioverter defibrillators can extend survival and improve functionality in properly selected cardiac patients, but given the lack of data from elderly individuals, choices can be complex and challenging.
“We don't have very good long-term randomized, prospective clinical trials in the very elderly to know exactly what the best therapy is,” Dr. Brian Olshansky said at the annual meeting of the Society of Geriatric Cardiology.
“Not everyone is going to be saved with an implantable cardioverter defibrillator [ICD],” said Dr. Olshansky, a professor of medicine and a cardiac electrophysiologist at the University of Iowa, Iowa City.
But device therapy can be beneficial in elderly patients with tachyarrhythmias or bradyarrhythmias because these conditions can significantly impair the patient's daily activities, he noted.
On the basis of results from a recent review of a Medicare database, “what we can say is that people who receive ICDs [whether single chamber, dual chamber, or with cardiac resynchronization pacing], presumably for the right reason, do better than those who don't in a Medicare population,” Dr. Olshansky said (Heart Rhythm 2008;5:646–53).
However, the benefit of pacemakers in this population is less clear. In the Pacemaker Selection in the Elderly (PASE) study, a single-blind, prospective, randomized trial that examined quality of life after pacemaker implantation in patients with a mean age of 76 years, use of a pacemaker significantly improved quality of life in patients with symptomatic bradycardia, but there was no difference in survival between dual- and single-chamber pacemakers, said Dr. Olshansky (N. Engl. J. Med. 1998;338:1097–104).
In some cases a pacemaker is only part of the solution in lieu of medications or procedures to treat tachyarrhythmias such as atrial fibrillation. Atrioventricular (AV) junction ablation can be an effective means of controlling fast ventricular rates caused by atrial fibrillation, improving quality of life and functionality.
“In my experience, elderly patients seem to get a tremendous benefit from AV junctional ablation in cases with fast rates in atrial fibrillation not controlled with medical therapy,” Dr. Olshansky said.
“What is really most important is that an AV junctional ablation can allow patients to do what they want to do, like carrying groceries and climbing stairs,” said Dr. Olshansky.
Cardiac resynchronization therapy (CRT) for patients with impaired ventricular function, functional class III or IV heart failure, and a wide QRS complex may be an appropriate option, but it has not been well studied in patients older than 80 years, and it is more complicated and expensive than a single-site option, he noted.
But potential benefits of CRT include improved quality of life, as well as reduced heart failure symptoms and improved exercise tolerance. Also, studies have shown that CRT can reduce hospitalization and the risk of death.
The Multicenter InSync Randomized Clinical Evaluation (MIRACLE) study, which included patients approximately 65 years old, significantly improved functional status over a 6-month follow-up period after CRT pacing, compared with a control group who received a CRT implant without pacing (N. Engl. J. Med. 2002;346:1845–53).
Another growing area is atrial fibrillation ablation, but older patients are at greater risk from this long, arduous procedure and they may derive less benefit, compared with a younger population. Although study findings suggest that this procedure may improve quality of life more than antiarrhythmic medications, these data do not include elderly patients.
Dr. Olshansky stated that he has served as a consultant and a member of the speakers bureaus for Medtronic, Boston Scientific, and Novartis.
Device therapy can be beneficial in elderlypatients with tachyarrhythmias or bradyarrhythmias. DR. OLSHANSKY
Natalizumab Cuts Hospitalization Rates for Crohn's Patients
SAN DIEGO — Treatment with natalizumab significantly reduced the rates of overall hospitalization and disease-specific hospitalization for adults with Crohn's disease, according to data from 1,373 adults presented at the annual Digestive Disease Week.
Hospitalization is one of the greatest expenses associated with Crohn's disease, and preventing hospitalization remains a major goal of treatment, said Dr. Bruce E. Sands, a gastroenterologist at Massachusetts General Hospital and Harvard Medical School, both in Boston.
To investigate the impact of natalizumab on all-cause and Crohn's-specific hospitalizations, Dr. Sands and his colleagues analyzed pooled data from two randomized, controlled trials—ENCORE (Efficacy of Natalizumab in Crohn's Disease Response and Remission) and ENACT-1 (Evaluation of Natalizumab as Continuous Therapy)—which included a total intent-to-treat population of 1,414 persons.
The two patient groups had an average age of 38 years and similar demographic characteristics at baseline. The patients had been randomly assigned to receive an intravenous dose of 300 mg natalizumab or a placebo every 4 weeks for a 12-week induction period. The hospitalization rate was calculated as hospital admissions per 100 courses (per 100 patients).
The study involved an additional analysis of a subgroup of 346 patients who had failed prior anti-TNF therapy and had active inflammation, as shown by elevated C-reactive protein levels.
“We observed a total of 136 all-cause hospitalizations in the entire cohort, and of these, 109 were Crohn's related,” Dr. Sands said.
In a multivariate analysis, natalizumab was associated with a significant reduction of 35% in the all-cause hospitalization rate. In addition, natalizumab use was associated with a comparable reduction of 30% in the Crohn's-related hospitalization rate, but this difference was not statistically significant.
In the multivariate model, the effect size was even more dramatic for the subset of anti-TNF-resistant patients. The all-cause hospitalization rate in this group was significantly lower for patients who received natalizumab, compared with placebo (9.7/100 patients vs. 20.8/100 patients). The Crohn's-related hospitalization rates also were significantly lower for natalizumab patients vs. placebo patients (6.3/100 patients vs. 12.8/100 patients).
“Both anti-TNF experience and elevated C-reactive protein were associated with greater risk of hospitalization,” Dr. Sands added.
In both univariate and multivariate analysis, the other independent predictors of hospitalization were low body mass index, baseline C-reactive protein level, prior anti-TNF experience, and elevation of baseline Crohn's Disease Activity Index (CDAI).
Dr. Sands has received consulting fees, grants, and research support from multiple pharmaceutical companies.
ELSEVIER GLOBAL MEDICAL NEWS
SAN DIEGO — Treatment with natalizumab significantly reduced the rates of overall hospitalization and disease-specific hospitalization for adults with Crohn's disease, according to data from 1,373 adults presented at the annual Digestive Disease Week.
Hospitalization is one of the greatest expenses associated with Crohn's disease, and preventing hospitalization remains a major goal of treatment, said Dr. Bruce E. Sands, a gastroenterologist at Massachusetts General Hospital and Harvard Medical School, both in Boston.
To investigate the impact of natalizumab on all-cause and Crohn's-specific hospitalizations, Dr. Sands and his colleagues analyzed pooled data from two randomized, controlled trials—ENCORE (Efficacy of Natalizumab in Crohn's Disease Response and Remission) and ENACT-1 (Evaluation of Natalizumab as Continuous Therapy)—which included a total intent-to-treat population of 1,414 persons.
The two patient groups had an average age of 38 years and similar demographic characteristics at baseline. The patients had been randomly assigned to receive an intravenous dose of 300 mg natalizumab or a placebo every 4 weeks for a 12-week induction period. The hospitalization rate was calculated as hospital admissions per 100 courses (per 100 patients).
The study involved an additional analysis of a subgroup of 346 patients who had failed prior anti-TNF therapy and had active inflammation, as shown by elevated C-reactive protein levels.
“We observed a total of 136 all-cause hospitalizations in the entire cohort, and of these, 109 were Crohn's related,” Dr. Sands said.
In a multivariate analysis, natalizumab was associated with a significant reduction of 35% in the all-cause hospitalization rate. In addition, natalizumab use was associated with a comparable reduction of 30% in the Crohn's-related hospitalization rate, but this difference was not statistically significant.
In the multivariate model, the effect size was even more dramatic for the subset of anti-TNF-resistant patients. The all-cause hospitalization rate in this group was significantly lower for patients who received natalizumab, compared with placebo (9.7/100 patients vs. 20.8/100 patients). The Crohn's-related hospitalization rates also were significantly lower for natalizumab patients vs. placebo patients (6.3/100 patients vs. 12.8/100 patients).
“Both anti-TNF experience and elevated C-reactive protein were associated with greater risk of hospitalization,” Dr. Sands added.
In both univariate and multivariate analysis, the other independent predictors of hospitalization were low body mass index, baseline C-reactive protein level, prior anti-TNF experience, and elevation of baseline Crohn's Disease Activity Index (CDAI).
Dr. Sands has received consulting fees, grants, and research support from multiple pharmaceutical companies.
ELSEVIER GLOBAL MEDICAL NEWS
SAN DIEGO — Treatment with natalizumab significantly reduced the rates of overall hospitalization and disease-specific hospitalization for adults with Crohn's disease, according to data from 1,373 adults presented at the annual Digestive Disease Week.
Hospitalization is one of the greatest expenses associated with Crohn's disease, and preventing hospitalization remains a major goal of treatment, said Dr. Bruce E. Sands, a gastroenterologist at Massachusetts General Hospital and Harvard Medical School, both in Boston.
To investigate the impact of natalizumab on all-cause and Crohn's-specific hospitalizations, Dr. Sands and his colleagues analyzed pooled data from two randomized, controlled trials—ENCORE (Efficacy of Natalizumab in Crohn's Disease Response and Remission) and ENACT-1 (Evaluation of Natalizumab as Continuous Therapy)—which included a total intent-to-treat population of 1,414 persons.
The two patient groups had an average age of 38 years and similar demographic characteristics at baseline. The patients had been randomly assigned to receive an intravenous dose of 300 mg natalizumab or a placebo every 4 weeks for a 12-week induction period. The hospitalization rate was calculated as hospital admissions per 100 courses (per 100 patients).
The study involved an additional analysis of a subgroup of 346 patients who had failed prior anti-TNF therapy and had active inflammation, as shown by elevated C-reactive protein levels.
“We observed a total of 136 all-cause hospitalizations in the entire cohort, and of these, 109 were Crohn's related,” Dr. Sands said.
In a multivariate analysis, natalizumab was associated with a significant reduction of 35% in the all-cause hospitalization rate. In addition, natalizumab use was associated with a comparable reduction of 30% in the Crohn's-related hospitalization rate, but this difference was not statistically significant.
In the multivariate model, the effect size was even more dramatic for the subset of anti-TNF-resistant patients. The all-cause hospitalization rate in this group was significantly lower for patients who received natalizumab, compared with placebo (9.7/100 patients vs. 20.8/100 patients). The Crohn's-related hospitalization rates also were significantly lower for natalizumab patients vs. placebo patients (6.3/100 patients vs. 12.8/100 patients).
“Both anti-TNF experience and elevated C-reactive protein were associated with greater risk of hospitalization,” Dr. Sands added.
In both univariate and multivariate analysis, the other independent predictors of hospitalization were low body mass index, baseline C-reactive protein level, prior anti-TNF experience, and elevation of baseline Crohn's Disease Activity Index (CDAI).
Dr. Sands has received consulting fees, grants, and research support from multiple pharmaceutical companies.
ELSEVIER GLOBAL MEDICAL NEWS
Safety, Not Sex, Tops Parents' Concerns About HPV Vaccine
Safety, not sexuality, was a key factor in the reluctance of mothers to have their teenage daughters vaccinated against human papillomavirus, according to results from a study published in the Journal of Adolescent Health.
The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices currently recommends a three-dose vaccine against the human papillomavirus (HPV) for all girls aged 11-12 years and young women aged 13-26 years. HPV has been identified as a leading cause of cervical cancer.
Previous studies have shown that parents were in favor of vaccination for adolescents but hesitant to vaccinate younger girls. But data from these studies have shown that in most cases, this resistance was not brought on by concerns that the vaccination might make teenage girls more likely to engage in risky sexual activities.
To examine the factors that influence parents' acceptance of the HPV vaccine, Susan L. Rosenthal, Ph.D., of the University of Texas Medical Branch in Galveston and her colleagues interviewed mothers with daughters aged 11-17 years who were visitors to a university-based primary care clinic.
The study included complete results from 153 mothers of various ethnicities (average age 41 years) who completed a questionnaire. The questionnaire included ratings of seven health beliefs including perceptions of HPV disease severity and barriers to vaccination, such as cost. The questionnaire also addressed aspects of the parent/child relationship, including how closely the girls' activities were monitored by parents and whether the parents had discussed topics such as birth control, dating, and making decisions about sex (J. Adolesc. Health 2008;43:239-45).
Overall, 18% (27) of the mothers had been offered the HPV vaccination for their daughters but had not chosen it, and did not plan to vaccinate their daughters within the next year, while 34% (52) had not been offered the vaccination and did not plan to vaccinate their daughters within the next year.
Another 22% (34) had not been offered the vaccine but were aware of it and planned to vaccinate their daughters within the next year, and 26% (40) of the mothers reported that their daughters had started or completed the HPV vaccination series.
None of the mothers whose daughters had been vaccinated said they viewed the vaccine as unsafe, but objections to the vaccine were focused mostly on the lack of safety data because of the newness of the vaccine.
Mothers who were offered the vaccine but did not plan to vaccinate their daughters within the year often cited a lack information about the vaccine, and some cited a lack of urgency based on their perceptions of their daughters' likely exposure to HPV.
Significant predictors of HPV vaccination after a multivariate analysis were mothers who had less than a high school education, had a history of sexually transmitted infections, had monitored their daughters' activities with peers, and had thought their daughters would not mind getting the shots.
There was no significant association between HPV vaccine acceptance and the ages and ethnicities of the mothers and daughters, the daughters' dating status, mothers' history of HPV, mother/daughter discussion of sex topics, or the general family environment.
“Although the study was not designed to examine the process of and impact of physician counseling, it appeared that those who had been counseled had more positive attitudes toward the vaccine and understood better the reasons for vaccinating their daughters prior to initiation of sexual activity,” the researchers noted.
The study was limited by the relatively small sample and by the university setting, which might have provided more education to parents and daughters than would other settings.
But the results suggest that even those parents and daughters who were counseled about the HPV vaccine wanted more information, and further studies are needed to determine the most effective ways to provide more education, the researchers wrote.
Many mothers who were not planning to vaccinate their daughters within the next year planned to vaccinate them eventually, they added.
The study was funded by grants from Merck & Co. and the National Institutes of Health.
Safety, not sexuality, was a key factor in the reluctance of mothers to have their teenage daughters vaccinated against human papillomavirus, according to results from a study published in the Journal of Adolescent Health.
The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices currently recommends a three-dose vaccine against the human papillomavirus (HPV) for all girls aged 11-12 years and young women aged 13-26 years. HPV has been identified as a leading cause of cervical cancer.
Previous studies have shown that parents were in favor of vaccination for adolescents but hesitant to vaccinate younger girls. But data from these studies have shown that in most cases, this resistance was not brought on by concerns that the vaccination might make teenage girls more likely to engage in risky sexual activities.
To examine the factors that influence parents' acceptance of the HPV vaccine, Susan L. Rosenthal, Ph.D., of the University of Texas Medical Branch in Galveston and her colleagues interviewed mothers with daughters aged 11-17 years who were visitors to a university-based primary care clinic.
The study included complete results from 153 mothers of various ethnicities (average age 41 years) who completed a questionnaire. The questionnaire included ratings of seven health beliefs including perceptions of HPV disease severity and barriers to vaccination, such as cost. The questionnaire also addressed aspects of the parent/child relationship, including how closely the girls' activities were monitored by parents and whether the parents had discussed topics such as birth control, dating, and making decisions about sex (J. Adolesc. Health 2008;43:239-45).
Overall, 18% (27) of the mothers had been offered the HPV vaccination for their daughters but had not chosen it, and did not plan to vaccinate their daughters within the next year, while 34% (52) had not been offered the vaccination and did not plan to vaccinate their daughters within the next year.
Another 22% (34) had not been offered the vaccine but were aware of it and planned to vaccinate their daughters within the next year, and 26% (40) of the mothers reported that their daughters had started or completed the HPV vaccination series.
None of the mothers whose daughters had been vaccinated said they viewed the vaccine as unsafe, but objections to the vaccine were focused mostly on the lack of safety data because of the newness of the vaccine.
Mothers who were offered the vaccine but did not plan to vaccinate their daughters within the year often cited a lack information about the vaccine, and some cited a lack of urgency based on their perceptions of their daughters' likely exposure to HPV.
Significant predictors of HPV vaccination after a multivariate analysis were mothers who had less than a high school education, had a history of sexually transmitted infections, had monitored their daughters' activities with peers, and had thought their daughters would not mind getting the shots.
There was no significant association between HPV vaccine acceptance and the ages and ethnicities of the mothers and daughters, the daughters' dating status, mothers' history of HPV, mother/daughter discussion of sex topics, or the general family environment.
“Although the study was not designed to examine the process of and impact of physician counseling, it appeared that those who had been counseled had more positive attitudes toward the vaccine and understood better the reasons for vaccinating their daughters prior to initiation of sexual activity,” the researchers noted.
The study was limited by the relatively small sample and by the university setting, which might have provided more education to parents and daughters than would other settings.
But the results suggest that even those parents and daughters who were counseled about the HPV vaccine wanted more information, and further studies are needed to determine the most effective ways to provide more education, the researchers wrote.
Many mothers who were not planning to vaccinate their daughters within the next year planned to vaccinate them eventually, they added.
The study was funded by grants from Merck & Co. and the National Institutes of Health.
Safety, not sexuality, was a key factor in the reluctance of mothers to have their teenage daughters vaccinated against human papillomavirus, according to results from a study published in the Journal of Adolescent Health.
The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices currently recommends a three-dose vaccine against the human papillomavirus (HPV) for all girls aged 11-12 years and young women aged 13-26 years. HPV has been identified as a leading cause of cervical cancer.
Previous studies have shown that parents were in favor of vaccination for adolescents but hesitant to vaccinate younger girls. But data from these studies have shown that in most cases, this resistance was not brought on by concerns that the vaccination might make teenage girls more likely to engage in risky sexual activities.
To examine the factors that influence parents' acceptance of the HPV vaccine, Susan L. Rosenthal, Ph.D., of the University of Texas Medical Branch in Galveston and her colleagues interviewed mothers with daughters aged 11-17 years who were visitors to a university-based primary care clinic.
The study included complete results from 153 mothers of various ethnicities (average age 41 years) who completed a questionnaire. The questionnaire included ratings of seven health beliefs including perceptions of HPV disease severity and barriers to vaccination, such as cost. The questionnaire also addressed aspects of the parent/child relationship, including how closely the girls' activities were monitored by parents and whether the parents had discussed topics such as birth control, dating, and making decisions about sex (J. Adolesc. Health 2008;43:239-45).
Overall, 18% (27) of the mothers had been offered the HPV vaccination for their daughters but had not chosen it, and did not plan to vaccinate their daughters within the next year, while 34% (52) had not been offered the vaccination and did not plan to vaccinate their daughters within the next year.
Another 22% (34) had not been offered the vaccine but were aware of it and planned to vaccinate their daughters within the next year, and 26% (40) of the mothers reported that their daughters had started or completed the HPV vaccination series.
None of the mothers whose daughters had been vaccinated said they viewed the vaccine as unsafe, but objections to the vaccine were focused mostly on the lack of safety data because of the newness of the vaccine.
Mothers who were offered the vaccine but did not plan to vaccinate their daughters within the year often cited a lack information about the vaccine, and some cited a lack of urgency based on their perceptions of their daughters' likely exposure to HPV.
Significant predictors of HPV vaccination after a multivariate analysis were mothers who had less than a high school education, had a history of sexually transmitted infections, had monitored their daughters' activities with peers, and had thought their daughters would not mind getting the shots.
There was no significant association between HPV vaccine acceptance and the ages and ethnicities of the mothers and daughters, the daughters' dating status, mothers' history of HPV, mother/daughter discussion of sex topics, or the general family environment.
“Although the study was not designed to examine the process of and impact of physician counseling, it appeared that those who had been counseled had more positive attitudes toward the vaccine and understood better the reasons for vaccinating their daughters prior to initiation of sexual activity,” the researchers noted.
The study was limited by the relatively small sample and by the university setting, which might have provided more education to parents and daughters than would other settings.
But the results suggest that even those parents and daughters who were counseled about the HPV vaccine wanted more information, and further studies are needed to determine the most effective ways to provide more education, the researchers wrote.
Many mothers who were not planning to vaccinate their daughters within the next year planned to vaccinate them eventually, they added.
The study was funded by grants from Merck & Co. and the National Institutes of Health.