Doug Brunk

Asymptomatic women with a family history of breast, ovarian, tubal, or peritoneal cancers should be screened for potentially increased risk for BRCA mutations, according to a new guideline from the U.S. Preventive Services Task Force.

Those with positive screening results should undergo genetic counseling to determine whether they should be tested for mutations in the breast cancer susceptibility genes BRCA1 and BRCA2, according to the guideline, which was published online Dec. 23 in Annals of Internal Medicine. The guideline applies only to at-risk women who have not been previously diagnosed with BRCA-related cancer and who have no signs or symptoms of the disease.

Genetic counseling "increases the accuracy of risk perception; decreases intention for mutation testing among women who are unlikely carriers; and decreases cancer worry, anxiety, and depression," according to the guideline writers. Routine genetic counseling and testing are not recommended for average-risk women.

BRCA1 and BRCA2 mutations occur in 0.2%-0.3% of women in the general population. The risk is higher in certain population subgroups: A meta-analysis showed that the combined prevalence of the mutations was 2.1% in a general population of Ashkenazi Jewish women, the guideline notes.

"Women should have their family history assessed to help make sure that clinicians identify the small number of women with BRCA mutations," Dr. Douglas K. Owens, a member of the U.S. Preventive Services Task Force (USPSTF), said in an interview. He emphasized that "most women would not need or not benefit from BRCA testing; it’s really a small minority."

The task force said that the new guideline reaffirms its 2005 recommendation on BRCA testing, but noted that an update was in order because "the potential benefits and harms of medications for breast cancer risk reduction have been studied for longer follow-up periods, and more information is available about the potential psychological effects of genetic counseling and risk-reducing surgery."

Additionally, family history risk-stratification tools are now available and have been developed and validated for use in primary care settings to guide referrals for BRCA genetic counseling. These include the Ontario Family History Assessment Tool, the Manchester Scoring System, the six-question Referral Screening Tool, the Pedigree Assessment Tool, and a seven-question family history screening instrument known as the FHS-7. These tools, which are all estimated to be more than 85% sensitive, "elicit information about factors associated with increased likelihood of BRCA mutations," wrote the members of the task force, which was chaired by Dr. Virginia A. Moyer, vice president for maintenance of certification and quality at the American Board of Pediatrics.

"The USPSTF recognizes that each risk-assessment tool has limitations, and found insufficient evidence to recommend one tool over another," the task force members wrote.

The guideline does not recommend a specific course of action for women who test positive for BRCA gene mutations. Options for women to consider include "intensive surveillance for breast cancer primarily, consideration of medications to reduce the risk of breast cancer, and either prophylactic mastectomy or prophylactic oophorectomy. If someone is BRCA-positive, the role of the primary care clinician is to have an initial discussion of what the person would like to consider. These would be discussions that might include other kinds of clinicians as well," said Dr. Owens, director of the Center for Primary Care and Outcomes Research at Stanford (Calif.) University.

Before issuing the new guideline, task force members reviewed evidence published in 2004 or later related to risk assessment, genetic counseling, and genetic testing for potentially harmful BRCA mutations in asymptomatic women with a family history of breast or ovarian cancer but no personal history of cancer or known potentially harmful BRCA mutations in their family. They also reviewed interventions aimed at reducing the risk for BRCA-related cancer in women with potentially harmful BRCA mutations.

In its evidence review, the task force concluded that limitations of studies included differences in designs and measures, dissimilar comparison groups, and small sizes. "Risk perception improved after receiving test results, and breast cancer worry and anxiety increased for women with positive results and decreased for others, although results were inconsistent. Studies were limited by high loss to follow-up and differences between comparison groups. Other relevant adverse effects of genetic testing were not studied, including false positive or negative results, genetic discrimination, and insurability."

The task force called for efforts to determine the appropriateness of risk assessment and testing for BRCA mutations in primary care, including research "on access to testing, effectiveness of screening approaches including risk stratification, use of system supports, and patient acceptance and education. Trials comparing types of providers and protocols could address questions about who should perform these services, how they should be done, and what skills are required. The consequences of identifying women as high risk, as well as genetic testing of individuals and their relatives, require more study."

The full recommendation is available here.

The review was funded by the Agency for Health Research and Quality. Task force member Dr. Kirsten Bibbins-Domingo disclosed that she has received grants from the American Heart Association, the Centers for Disease Control and Prevention, and the National Institutes of Health. Task force member Dr. Michael P. Pignone disclosed that he has received a grant from the American Cancer Society. The other task force members stated that they had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

Asymptomatic women with a family history of breast, ovarian, tubal, or peritoneal cancers should be screened for potentially increased risk for BRCA mutations, according to a new guideline from the U.S. Preventive Services Task Force.

Those with positive screening results should undergo genetic counseling to determine whether they should be tested for mutations in the breast cancer susceptibility genes BRCA1 and BRCA2, according to the guideline, which was published online Dec. 23 in Annals of Internal Medicine. The guideline applies only to at-risk women who have not been previously diagnosed with BRCA-related cancer and who have no signs or symptoms of the disease.

Genetic counseling "increases the accuracy of risk perception; decreases intention for mutation testing among women who are unlikely carriers; and decreases cancer worry, anxiety, and depression," according to the guideline writers. Routine genetic counseling and testing are not recommended for average-risk women.

BRCA1 and BRCA2 mutations occur in 0.2%-0.3% of women in the general population. The risk is higher in certain population subgroups: A meta-analysis showed that the combined prevalence of the mutations was 2.1% in a general population of Ashkenazi Jewish women, the guideline notes.

"Women should have their family history assessed to help make sure that clinicians identify the small number of women with BRCA mutations," Dr. Douglas K. Owens, a member of the U.S. Preventive Services Task Force (USPSTF), said in an interview. He emphasized that "most women would not need or not benefit from BRCA testing; it’s really a small minority."

The task force said that the new guideline reaffirms its 2005 recommendation on BRCA testing, but noted that an update was in order because "the potential benefits and harms of medications for breast cancer risk reduction have been studied for longer follow-up periods, and more information is available about the potential psychological effects of genetic counseling and risk-reducing surgery."

Additionally, family history risk-stratification tools are now available and have been developed and validated for use in primary care settings to guide referrals for BRCA genetic counseling. These include the Ontario Family History Assessment Tool, the Manchester Scoring System, the six-question Referral Screening Tool, the Pedigree Assessment Tool, and a seven-question family history screening instrument known as the FHS-7. These tools, which are all estimated to be more than 85% sensitive, "elicit information about factors associated with increased likelihood of BRCA mutations," wrote the members of the task force, which was chaired by Dr. Virginia A. Moyer, vice president for maintenance of certification and quality at the American Board of Pediatrics.

"The USPSTF recognizes that each risk-assessment tool has limitations, and found insufficient evidence to recommend one tool over another," the task force members wrote.

The guideline does not recommend a specific course of action for women who test positive for BRCA gene mutations. Options for women to consider include "intensive surveillance for breast cancer primarily, consideration of medications to reduce the risk of breast cancer, and either prophylactic mastectomy or prophylactic oophorectomy. If someone is BRCA-positive, the role of the primary care clinician is to have an initial discussion of what the person would like to consider. These would be discussions that might include other kinds of clinicians as well," said Dr. Owens, director of the Center for Primary Care and Outcomes Research at Stanford (Calif.) University.

Before issuing the new guideline, task force members reviewed evidence published in 2004 or later related to risk assessment, genetic counseling, and genetic testing for potentially harmful BRCA mutations in asymptomatic women with a family history of breast or ovarian cancer but no personal history of cancer or known potentially harmful BRCA mutations in their family. They also reviewed interventions aimed at reducing the risk for BRCA-related cancer in women with potentially harmful BRCA mutations.

In its evidence review, the task force concluded that limitations of studies included differences in designs and measures, dissimilar comparison groups, and small sizes. "Risk perception improved after receiving test results, and breast cancer worry and anxiety increased for women with positive results and decreased for others, although results were inconsistent. Studies were limited by high loss to follow-up and differences between comparison groups. Other relevant adverse effects of genetic testing were not studied, including false positive or negative results, genetic discrimination, and insurability."

The task force called for efforts to determine the appropriateness of risk assessment and testing for BRCA mutations in primary care, including research "on access to testing, effectiveness of screening approaches including risk stratification, use of system supports, and patient acceptance and education. Trials comparing types of providers and protocols could address questions about who should perform these services, how they should be done, and what skills are required. The consequences of identifying women as high risk, as well as genetic testing of individuals and their relatives, require more study."

The full recommendation is available here.

The review was funded by the Agency for Health Research and Quality. Task force member Dr. Kirsten Bibbins-Domingo disclosed that she has received grants from the American Heart Association, the Centers for Disease Control and Prevention, and the National Institutes of Health. Task force member Dr. Michael P. Pignone disclosed that he has received a grant from the American Cancer Society. The other task force members stated that they had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

Asymptomatic women with a family history of breast, ovarian, tubal, or peritoneal cancers should be screened for potentially increased risk for BRCA mutations, according to a new guideline from the U.S. Preventive Services Task Force.

Those with positive screening results should undergo genetic counseling to determine whether they should be tested for mutations in the breast cancer susceptibility genes BRCA1 and BRCA2, according to the guideline, which was published online Dec. 23 in Annals of Internal Medicine. The guideline applies only to at-risk women who have not been previously diagnosed with BRCA-related cancer and who have no signs or symptoms of the disease.

Genetic counseling "increases the accuracy of risk perception; decreases intention for mutation testing among women who are unlikely carriers; and decreases cancer worry, anxiety, and depression," according to the guideline writers. Routine genetic counseling and testing are not recommended for average-risk women.

BRCA1 and BRCA2 mutations occur in 0.2%-0.3% of women in the general population. The risk is higher in certain population subgroups: A meta-analysis showed that the combined prevalence of the mutations was 2.1% in a general population of Ashkenazi Jewish women, the guideline notes.

"Women should have their family history assessed to help make sure that clinicians identify the small number of women with BRCA mutations," Dr. Douglas K. Owens, a member of the U.S. Preventive Services Task Force (USPSTF), said in an interview. He emphasized that "most women would not need or not benefit from BRCA testing; it’s really a small minority."

The task force said that the new guideline reaffirms its 2005 recommendation on BRCA testing, but noted that an update was in order because "the potential benefits and harms of medications for breast cancer risk reduction have been studied for longer follow-up periods, and more information is available about the potential psychological effects of genetic counseling and risk-reducing surgery."

Additionally, family history risk-stratification tools are now available and have been developed and validated for use in primary care settings to guide referrals for BRCA genetic counseling. These include the Ontario Family History Assessment Tool, the Manchester Scoring System, the six-question Referral Screening Tool, the Pedigree Assessment Tool, and a seven-question family history screening instrument known as the FHS-7. These tools, which are all estimated to be more than 85% sensitive, "elicit information about factors associated with increased likelihood of BRCA mutations," wrote the members of the task force, which was chaired by Dr. Virginia A. Moyer, vice president for maintenance of certification and quality at the American Board of Pediatrics.

"The USPSTF recognizes that each risk-assessment tool has limitations, and found insufficient evidence to recommend one tool over another," the task force members wrote.

The guideline does not recommend a specific course of action for women who test positive for BRCA gene mutations. Options for women to consider include "intensive surveillance for breast cancer primarily, consideration of medications to reduce the risk of breast cancer, and either prophylactic mastectomy or prophylactic oophorectomy. If someone is BRCA-positive, the role of the primary care clinician is to have an initial discussion of what the person would like to consider. These would be discussions that might include other kinds of clinicians as well," said Dr. Owens, director of the Center for Primary Care and Outcomes Research at Stanford (Calif.) University.

Before issuing the new guideline, task force members reviewed evidence published in 2004 or later related to risk assessment, genetic counseling, and genetic testing for potentially harmful BRCA mutations in asymptomatic women with a family history of breast or ovarian cancer but no personal history of cancer or known potentially harmful BRCA mutations in their family. They also reviewed interventions aimed at reducing the risk for BRCA-related cancer in women with potentially harmful BRCA mutations.

In its evidence review, the task force concluded that limitations of studies included differences in designs and measures, dissimilar comparison groups, and small sizes. "Risk perception improved after receiving test results, and breast cancer worry and anxiety increased for women with positive results and decreased for others, although results were inconsistent. Studies were limited by high loss to follow-up and differences between comparison groups. Other relevant adverse effects of genetic testing were not studied, including false positive or negative results, genetic discrimination, and insurability."

The task force called for efforts to determine the appropriateness of risk assessment and testing for BRCA mutations in primary care, including research "on access to testing, effectiveness of screening approaches including risk stratification, use of system supports, and patient acceptance and education. Trials comparing types of providers and protocols could address questions about who should perform these services, how they should be done, and what skills are required. The consequences of identifying women as high risk, as well as genetic testing of individuals and their relatives, require more study."

The full recommendation is available here.

The review was funded by the Agency for Health Research and Quality. Task force member Dr. Kirsten Bibbins-Domingo disclosed that she has received grants from the American Heart Association, the Centers for Disease Control and Prevention, and the National Institutes of Health. Task force member Dr. Michael P. Pignone disclosed that he has received a grant from the American Cancer Society. The other task force members stated that they had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

Asymptomatic women with a family history of breast, ovarian, tubal, or peritoneal cancers should be screened for potentially increased risk for BRCA mutations, according to a new guideline from the U.S. Preventive Services Task Force.

Those with positive screening results should undergo genetic counseling to determine whether they should be tested for mutations in the breast cancer susceptibility genes BRCA1 and BRCA2, according to the guideline, which was published online Dec. 23 in Annals of Internal Medicine. The guideline applies only to at-risk women who have not been previously diagnosed with BRCA-related cancer and who have no signs or symptoms of the disease.

Genetic counseling "increases the accuracy of risk perception; decreases intention for mutation testing among women who are unlikely carriers; and decreases cancer worry, anxiety, and depression," according to the guideline writers. Routine genetic counseling and testing are not recommended for average-risk women.

BRCA1 and BRCA2 mutations occur in 0.2%-0.3% of women in the general population. The risk is higher in certain population subgroups: A meta-analysis showed that the combined prevalence of the mutations was 2.1% in a general population of Ashkenazi Jewish women, the guideline notes.

"Women should have their family history assessed to help make sure that clinicians identify the small number of women with BRCA mutations," Dr. Douglas K. Owens, a member of the U.S. Preventive Services Task Force (USPSTF), said in an interview. He emphasized that "most women would not need or not benefit from BRCA testing; it’s really a small minority."

The task force said that the new guideline reaffirms its 2005 recommendation on BRCA testing, but noted that an update was in order because "the potential benefits and harms of medications for breast cancer risk reduction have been studied for longer follow-up periods, and more information is available about the potential psychological effects of genetic counseling and risk-reducing surgery."

Additionally, family history risk-stratification tools are now available and have been developed and validated for use in primary care settings to guide referrals for BRCA genetic counseling. These include the Ontario Family History Assessment Tool, the Manchester Scoring System, the six-question Referral Screening Tool, the Pedigree Assessment Tool, and a seven-question family history screening instrument known as the FHS-7. These tools, which are all estimated to be more than 85% sensitive, "elicit information about factors associated with increased likelihood of BRCA mutations," wrote the members of the task force, which was chaired by Dr. Virginia A. Moyer, vice president for maintenance of certification and quality at the American Board of Pediatrics.

"The USPSTF recognizes that each risk-assessment tool has limitations, and found insufficient evidence to recommend one tool over another," the task force members wrote.

The guideline does not recommend a specific course of action for women who test positive for BRCA gene mutations. Options for women to consider include "intensive surveillance for breast cancer primarily, consideration of medications to reduce the risk of breast cancer, and either prophylactic mastectomy or prophylactic oophorectomy. If someone is BRCA-positive, the role of the primary care clinician is to have an initial discussion of what the person would like to consider. These would be discussions that might include other kinds of clinicians as well," said Dr. Owens, director of the Center for Primary Care and Outcomes Research at Stanford (Calif.) University.

Before issuing the new guideline, task force members reviewed evidence published in 2004 or later related to risk assessment, genetic counseling, and genetic testing for potentially harmful BRCA mutations in asymptomatic women with a family history of breast or ovarian cancer but no personal history of cancer or known potentially harmful BRCA mutations in their family. They also reviewed interventions aimed at reducing the risk for BRCA-related cancer in women with potentially harmful BRCA mutations.

In its evidence review, the task force concluded that limitations of studies included differences in designs and measures, dissimilar comparison groups, and small sizes. "Risk perception improved after receiving test results, and breast cancer worry and anxiety increased for women with positive results and decreased for others, although results were inconsistent. Studies were limited by high loss to follow-up and differences between comparison groups. Other relevant adverse effects of genetic testing were not studied, including false positive or negative results, genetic discrimination, and insurability."

The task force called for efforts to determine the appropriateness of risk assessment and testing for BRCA mutations in primary care, including research "on access to testing, effectiveness of screening approaches including risk stratification, use of system supports, and patient acceptance and education. Trials comparing types of providers and protocols could address questions about who should perform these services, how they should be done, and what skills are required. The consequences of identifying women as high risk, as well as genetic testing of individuals and their relatives, require more study."

The full recommendation is available here.

The review was funded by the Agency for Health Research and Quality. Task force member Dr. Kirsten Bibbins-Domingo disclosed that she has received grants from the American Heart Association, the Centers for Disease Control and Prevention, and the National Institutes of Health. Task force member Dr. Michael P. Pignone disclosed that he has received a grant from the American Cancer Society. The other task force members stated that they had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

Asymptomatic women with a family history of breast, ovarian, tubal, or peritoneal cancers should be screened for potentially increased risk for BRCA mutations, according to a new guideline from the U.S. Preventive Services Task Force.

Those with positive screening results should undergo genetic counseling to determine whether they should be tested for mutations in the breast cancer susceptibility genes BRCA1 and BRCA2, according to the guideline, which was published online Dec. 23 in Annals of Internal Medicine. The guideline applies only to at-risk women who have not been previously diagnosed with BRCA-related cancer and who have no signs or symptoms of the disease.

Genetic counseling "increases the accuracy of risk perception; decreases intention for mutation testing among women who are unlikely carriers; and decreases cancer worry, anxiety, and depression," according to the guideline writers. Routine genetic counseling and testing are not recommended for average-risk women.

BRCA1 and BRCA2 mutations occur in 0.2%-0.3% of women in the general population. The risk is higher in certain population subgroups: A meta-analysis showed that the combined prevalence of the mutations was 2.1% in a general population of Ashkenazi Jewish women, the guideline notes.

"Women should have their family history assessed to help make sure that clinicians identify the small number of women with BRCA mutations," Dr. Douglas K. Owens, a member of the U.S. Preventive Services Task Force (USPSTF), said in an interview. He emphasized that "most women would not need or not benefit from BRCA testing; it’s really a small minority."

The task force said that the new guideline reaffirms its 2005 recommendation on BRCA testing, but noted that an update was in order because "the potential benefits and harms of medications for breast cancer risk reduction have been studied for longer follow-up periods, and more information is available about the potential psychological effects of genetic counseling and risk-reducing surgery."

Additionally, family history risk-stratification tools are now available and have been developed and validated for use in primary care settings to guide referrals for BRCA genetic counseling. These include the Ontario Family History Assessment Tool, the Manchester Scoring System, the six-question Referral Screening Tool, the Pedigree Assessment Tool, and a seven-question family history screening instrument known as the FHS-7. These tools, which are all estimated to be more than 85% sensitive, "elicit information about factors associated with increased likelihood of BRCA mutations," wrote the members of the task force, which was chaired by Dr. Virginia A. Moyer, vice president for maintenance of certification and quality at the American Board of Pediatrics.

"The USPSTF recognizes that each risk-assessment tool has limitations, and found insufficient evidence to recommend one tool over another," the task force members wrote.

The guideline does not recommend a specific course of action for women who test positive for BRCA gene mutations. Options for women to consider include "intensive surveillance for breast cancer primarily, consideration of medications to reduce the risk of breast cancer, and either prophylactic mastectomy or prophylactic oophorectomy. If someone is BRCA-positive, the role of the primary care clinician is to have an initial discussion of what the person would like to consider. These would be discussions that might include other kinds of clinicians as well," said Dr. Owens, director of the Center for Primary Care and Outcomes Research at Stanford (Calif.) University.

Before issuing the new guideline, task force members reviewed evidence published in 2004 or later related to risk assessment, genetic counseling, and genetic testing for potentially harmful BRCA mutations in asymptomatic women with a family history of breast or ovarian cancer but no personal history of cancer or known potentially harmful BRCA mutations in their family. They also reviewed interventions aimed at reducing the risk for BRCA-related cancer in women with potentially harmful BRCA mutations.

In its evidence review, the task force concluded that limitations of studies included differences in designs and measures, dissimilar comparison groups, and small sizes. "Risk perception improved after receiving test results, and breast cancer worry and anxiety increased for women with positive results and decreased for others, although results were inconsistent. Studies were limited by high loss to follow-up and differences between comparison groups. Other relevant adverse effects of genetic testing were not studied, including false positive or negative results, genetic discrimination, and insurability."

The task force called for efforts to determine the appropriateness of risk assessment and testing for BRCA mutations in primary care, including research "on access to testing, effectiveness of screening approaches including risk stratification, use of system supports, and patient acceptance and education. Trials comparing types of providers and protocols could address questions about who should perform these services, how they should be done, and what skills are required. The consequences of identifying women as high risk, as well as genetic testing of individuals and their relatives, require more study."

The full recommendation is available here.

The review was funded by the Agency for Health Research and Quality. Task force member Dr. Kirsten Bibbins-Domingo disclosed that she has received grants from the American Heart Association, the Centers for Disease Control and Prevention, and the National Institutes of Health. Task force member Dr. Michael P. Pignone disclosed that he has received a grant from the American Cancer Society. The other task force members stated that they had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

Asymptomatic women with a family history of breast, ovarian, tubal, or peritoneal cancers should be screened for potentially increased risk for BRCA mutations, according to a new guideline from the U.S. Preventive Services Task Force.

Those with positive screening results should undergo genetic counseling to determine whether they should be tested for mutations in the breast cancer susceptibility genes BRCA1 and BRCA2, according to the guideline, which was published online Dec. 23 in Annals of Internal Medicine. The guideline applies only to at-risk women who have not been previously diagnosed with BRCA-related cancer and who have no signs or symptoms of the disease.

Genetic counseling "increases the accuracy of risk perception; decreases intention for mutation testing among women who are unlikely carriers; and decreases cancer worry, anxiety, and depression," according to the guideline writers. Routine genetic counseling and testing are not recommended for average-risk women.

BRCA1 and BRCA2 mutations occur in 0.2%-0.3% of women in the general population. The risk is higher in certain population subgroups: A meta-analysis showed that the combined prevalence of the mutations was 2.1% in a general population of Ashkenazi Jewish women, the guideline notes.

"Women should have their family history assessed to help make sure that clinicians identify the small number of women with BRCA mutations," Dr. Douglas K. Owens, a member of the U.S. Preventive Services Task Force (USPSTF), said in an interview. He emphasized that "most women would not need or not benefit from BRCA testing; it’s really a small minority."

The task force said that the new guideline reaffirms its 2005 recommendation on BRCA testing, but noted that an update was in order because "the potential benefits and harms of medications for breast cancer risk reduction have been studied for longer follow-up periods, and more information is available about the potential psychological effects of genetic counseling and risk-reducing surgery."

Additionally, family history risk-stratification tools are now available and have been developed and validated for use in primary care settings to guide referrals for BRCA genetic counseling. These include the Ontario Family History Assessment Tool, the Manchester Scoring System, the six-question Referral Screening Tool, the Pedigree Assessment Tool, and a seven-question family history screening instrument known as the FHS-7. These tools, which are all estimated to be more than 85% sensitive, "elicit information about factors associated with increased likelihood of BRCA mutations," wrote the members of the task force, which was chaired by Dr. Virginia A. Moyer, vice president for maintenance of certification and quality at the American Board of Pediatrics.

"The USPSTF recognizes that each risk-assessment tool has limitations, and found insufficient evidence to recommend one tool over another," the task force members wrote.

The guideline does not recommend a specific course of action for women who test positive for BRCA gene mutations. Options for women to consider include "intensive surveillance for breast cancer primarily, consideration of medications to reduce the risk of breast cancer, and either prophylactic mastectomy or prophylactic oophorectomy. If someone is BRCA-positive, the role of the primary care clinician is to have an initial discussion of what the person would like to consider. These would be discussions that might include other kinds of clinicians as well," said Dr. Owens, director of the Center for Primary Care and Outcomes Research at Stanford (Calif.) University.

Before issuing the new guideline, task force members reviewed evidence published in 2004 or later related to risk assessment, genetic counseling, and genetic testing for potentially harmful BRCA mutations in asymptomatic women with a family history of breast or ovarian cancer but no personal history of cancer or known potentially harmful BRCA mutations in their family. They also reviewed interventions aimed at reducing the risk for BRCA-related cancer in women with potentially harmful BRCA mutations.

In its evidence review, the task force concluded that limitations of studies included differences in designs and measures, dissimilar comparison groups, and small sizes. "Risk perception improved after receiving test results, and breast cancer worry and anxiety increased for women with positive results and decreased for others, although results were inconsistent. Studies were limited by high loss to follow-up and differences between comparison groups. Other relevant adverse effects of genetic testing were not studied, including false positive or negative results, genetic discrimination, and insurability."

The task force called for efforts to determine the appropriateness of risk assessment and testing for BRCA mutations in primary care, including research "on access to testing, effectiveness of screening approaches including risk stratification, use of system supports, and patient acceptance and education. Trials comparing types of providers and protocols could address questions about who should perform these services, how they should be done, and what skills are required. The consequences of identifying women as high risk, as well as genetic testing of individuals and their relatives, require more study."

The full recommendation is available here.

The review was funded by the Agency for Health Research and Quality. Task force member Dr. Kirsten Bibbins-Domingo disclosed that she has received grants from the American Heart Association, the Centers for Disease Control and Prevention, and the National Institutes of Health. Task force member Dr. Michael P. Pignone disclosed that he has received a grant from the American Cancer Society. The other task force members stated that they had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

The more anxious you are, the greater your chances of an incident stroke, results from a prospective analysis demonstrated. The association was independent of other known risk factors including depression, researchers led by Maya J. Lambiase, Ph.D., reported online Dec. 19, 2013, in the journal Stroke.

"Results indicated a dose-response relation between anxiety and stroke," according to Dr. Lambiase, a cardiovascular behavioral medicine researcher in the department of psychiatry at the University of Pittsburgh, and her associates. "Exploratory analyses suggest that behavioral factors, particularly smoking and physical activity, may be important pathways to consider."

Over a period of 22 years, the researchers studied a nationally representative sample of 6,019 people aged 25-74 years from the first National Health and Nutrition Examination Survey (NHANES I), which was conducted from 1971-1975. At baseline, all study participants underwent an in-person structured interview, physical exam, and blood draw, and they completed psychological questionnaires including the General Well-Being Schedule (GWB), a four-item tool that asks respondents to rate the severity of their anxiety-related symptoms during the past month. Strokes were identified through hospital or nursing home reports and death certificates. Numerous covariates were accounted for, including use of blood medications, diagnosis of diabetes by a physician, total serum cholesterol, body mass index, and depressive symptoms as measured by the GWB’s depressed mood subscale and by the Center for Epidemiologic Studies of Depression scale (CESD).

During a mean 16-year follow-up, the researchers identified 419 cases of incident strokes (221 in men and 198 in women). They observed that every one standard deviation increase in anxiety was associated with a 17% increase in stroke risk following adjustment for demographic factors. Men and women in the highest tertile of anxiety symptoms had a 33% higher risk of stroke, compared with those in the lowest tertile following adjustment for other cardiovascular risk factors.

"Poor health behaviors may be one pathway linking anxiety with stroke risk," the researchers wrote. "In the present study, behaviors (particularly smoking and physical activity) had the most sizable attenuating effect on the relationship between anxiety and incident stroke. However, since these behaviors did not account fully for the association between anxiety and incident stroke, direct biologic effects of anxiety should also be considered. Chronic anxiety could lead to excess activation of the hypothalamic-pituitary-adrenal axis and sympathetic nervous system, which may increase the risk for stroke. Anxiety could also contribute to stroke or other cardiovascular disease by lowering the threshold for arrhythmia or by reducing heart rate variability."

The researchers acknowledged certain limitations of the study, including the fact that baseline history of stroke and coronary heart disease were self-reported and that bias "may have occurred due to excluding individuals lost to follow-up or with missing data. We could not formally test mediation due to insufficiencies in temporal ordering of data collection. Stroke cases were identified based on discharge reports/death certificates and were not confirmed by imaging or a neurologist. Additionally, we may not have accurately captured silent strokes (resulting in an underestimate of cases in the population), although such misclassification would likely bias results toward the null."

The study coauthors were Laura D. Kubzansky, Ph.D., and Rebecca Thurston, Ph.D.

The study was funded by the National Heart, Lung, and Blood Institute and by the National Institute of Mental Health. The researchers stated that they had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

The more anxious you are, the greater your chances of an incident stroke, results from a prospective analysis demonstrated. The association was independent of other known risk factors including depression, researchers led by Maya J. Lambiase, Ph.D., reported online Dec. 19, 2013, in the journal Stroke.

"Results indicated a dose-response relation between anxiety and stroke," according to Dr. Lambiase, a cardiovascular behavioral medicine researcher in the department of psychiatry at the University of Pittsburgh, and her associates. "Exploratory analyses suggest that behavioral factors, particularly smoking and physical activity, may be important pathways to consider."

Over a period of 22 years, the researchers studied a nationally representative sample of 6,019 people aged 25-74 years from the first National Health and Nutrition Examination Survey (NHANES I), which was conducted from 1971-1975. At baseline, all study participants underwent an in-person structured interview, physical exam, and blood draw, and they completed psychological questionnaires including the General Well-Being Schedule (GWB), a four-item tool that asks respondents to rate the severity of their anxiety-related symptoms during the past month. Strokes were identified through hospital or nursing home reports and death certificates. Numerous covariates were accounted for, including use of blood medications, diagnosis of diabetes by a physician, total serum cholesterol, body mass index, and depressive symptoms as measured by the GWB’s depressed mood subscale and by the Center for Epidemiologic Studies of Depression scale (CESD).

During a mean 16-year follow-up, the researchers identified 419 cases of incident strokes (221 in men and 198 in women). They observed that every one standard deviation increase in anxiety was associated with a 17% increase in stroke risk following adjustment for demographic factors. Men and women in the highest tertile of anxiety symptoms had a 33% higher risk of stroke, compared with those in the lowest tertile following adjustment for other cardiovascular risk factors.

"Poor health behaviors may be one pathway linking anxiety with stroke risk," the researchers wrote. "In the present study, behaviors (particularly smoking and physical activity) had the most sizable attenuating effect on the relationship between anxiety and incident stroke. However, since these behaviors did not account fully for the association between anxiety and incident stroke, direct biologic effects of anxiety should also be considered. Chronic anxiety could lead to excess activation of the hypothalamic-pituitary-adrenal axis and sympathetic nervous system, which may increase the risk for stroke. Anxiety could also contribute to stroke or other cardiovascular disease by lowering the threshold for arrhythmia or by reducing heart rate variability."

The researchers acknowledged certain limitations of the study, including the fact that baseline history of stroke and coronary heart disease were self-reported and that bias "may have occurred due to excluding individuals lost to follow-up or with missing data. We could not formally test mediation due to insufficiencies in temporal ordering of data collection. Stroke cases were identified based on discharge reports/death certificates and were not confirmed by imaging or a neurologist. Additionally, we may not have accurately captured silent strokes (resulting in an underestimate of cases in the population), although such misclassification would likely bias results toward the null."

The study coauthors were Laura D. Kubzansky, Ph.D., and Rebecca Thurston, Ph.D.

The study was funded by the National Heart, Lung, and Blood Institute and by the National Institute of Mental Health. The researchers stated that they had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

The more anxious you are, the greater your chances of an incident stroke, results from a prospective analysis demonstrated. The association was independent of other known risk factors including depression, researchers led by Maya J. Lambiase, Ph.D., reported online Dec. 19, 2013, in the journal Stroke.

"Results indicated a dose-response relation between anxiety and stroke," according to Dr. Lambiase, a cardiovascular behavioral medicine researcher in the department of psychiatry at the University of Pittsburgh, and her associates. "Exploratory analyses suggest that behavioral factors, particularly smoking and physical activity, may be important pathways to consider."

Over a period of 22 years, the researchers studied a nationally representative sample of 6,019 people aged 25-74 years from the first National Health and Nutrition Examination Survey (NHANES I), which was conducted from 1971-1975. At baseline, all study participants underwent an in-person structured interview, physical exam, and blood draw, and they completed psychological questionnaires including the General Well-Being Schedule (GWB), a four-item tool that asks respondents to rate the severity of their anxiety-related symptoms during the past month. Strokes were identified through hospital or nursing home reports and death certificates. Numerous covariates were accounted for, including use of blood medications, diagnosis of diabetes by a physician, total serum cholesterol, body mass index, and depressive symptoms as measured by the GWB’s depressed mood subscale and by the Center for Epidemiologic Studies of Depression scale (CESD).

During a mean 16-year follow-up, the researchers identified 419 cases of incident strokes (221 in men and 198 in women). They observed that every one standard deviation increase in anxiety was associated with a 17% increase in stroke risk following adjustment for demographic factors. Men and women in the highest tertile of anxiety symptoms had a 33% higher risk of stroke, compared with those in the lowest tertile following adjustment for other cardiovascular risk factors.

"Poor health behaviors may be one pathway linking anxiety with stroke risk," the researchers wrote. "In the present study, behaviors (particularly smoking and physical activity) had the most sizable attenuating effect on the relationship between anxiety and incident stroke. However, since these behaviors did not account fully for the association between anxiety and incident stroke, direct biologic effects of anxiety should also be considered. Chronic anxiety could lead to excess activation of the hypothalamic-pituitary-adrenal axis and sympathetic nervous system, which may increase the risk for stroke. Anxiety could also contribute to stroke or other cardiovascular disease by lowering the threshold for arrhythmia or by reducing heart rate variability."

The researchers acknowledged certain limitations of the study, including the fact that baseline history of stroke and coronary heart disease were self-reported and that bias "may have occurred due to excluding individuals lost to follow-up or with missing data. We could not formally test mediation due to insufficiencies in temporal ordering of data collection. Stroke cases were identified based on discharge reports/death certificates and were not confirmed by imaging or a neurologist. Additionally, we may not have accurately captured silent strokes (resulting in an underestimate of cases in the population), although such misclassification would likely bias results toward the null."

The study coauthors were Laura D. Kubzansky, Ph.D., and Rebecca Thurston, Ph.D.

The study was funded by the National Heart, Lung, and Blood Institute and by the National Institute of Mental Health. The researchers stated that they had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – "It’s not your fault."

Family physicians should relay those words of assurance to patients who present to them with early pregnancy loss, according to Dr. Linda Prine.

"In busy emergency rooms, that’s rarely the kind of thing an ER doc is going to have time to sit down and discuss with the patient," said Dr. Prine, women’s health director of the Institute for Family Health in New York. "They’re trying to make a diagnosis and move the patient on. Here you often have a woman who’s already thinking about what color she’s going to paint the bedroom, or buying a baby crib, or a stroller. This feels like a tragic loss to her. It needs to be explained gently as a natural process and some time taken for understanding. Her partner also needs to hear that it wasn’t her fault or his fault. It wasn’t the sex they had, the snow she shoveled – all of the things that start to go through a woman’s mind to blame herself."

Risk factors for miscarriage include advanced age or very young age, having prior miscarriages, smoking, cocaine use, and fever or infection. Contrary to myth, air travel does not cause miscarriage, she continued, and blunt abdominal trauma, contraceptive use, exercise, the human papillomavirus vaccine, previous abortions, and sexual activity are also not to blame.

Options for miscarriage include expectant management, medication management, and an aspiration procedure. "The patient should be involved in the decision making here," Dr. Prine said at the annual meeting of the American Academy of Family Physicians. "When the women are involved, their mental health outcomes are better. Family physicians are best suited to work through these events with our patients."

The potential risks of expectant management are rare but include infection, the need for emergent uterine aspiration, and bleeding or the need for blood transfusion. The benefits of expectant management include "avoiding the risks, though rare, that can happen with instrumentation such as perforation, introducing infection, or bleeding from a procedure that’s done too vigorously," she noted.

Fever with a tender uterus is a contraindication for expectant management. Incomplete abortions are more likely to have successful expectant management than are fetal demises or anembryonic pregnancies (at day 49, a success rate of 91% vs. 76% and 66%, respectively). "There’s no outside limit for how long you can wait for expectant management," Dr. Prine said. "Usually the woman is not going to want to wait for weeks and weeks, and that becomes the patient-centered limiting factor. How heavy can the bleeding get before she should start to worry about it? If she’s bleeding through two pads an hour for 2 hours back to back, she should call us, though this is rare."

For medical management of an early pregnancy loss, a common protocol involves 800 mcg misoprostol administered vaginally or buccally and repeated in 24 hours if the abortion is incomplete, with vacuum aspiration on day 8 if still incomplete. "Alternative oral regimens cause more GI side effects," Dr. Prine said. Side effects of misoprostol are bleeding, cramping, fever and/or chills, nausea and vomiting, and diarrhea. Misoprostol treatment is safest when used 10 weeks or less after an ultrasound exam confirming the pregnancy loss. "Rule out ectopic pregnancy because the medical treatment for ectopic pregnancy differs from miscarriage treatment," she said. Testing may include an ultrasound, an rh factor screen, hematocrit assessment, and measurement of the serum human chorionic gonadotropin level.

If medical management is not working, "we can repeat the misoprostol again, or she can come into the office for an aspiration procedure," Dr. Prine said.

Sample clinical protocols, patient education sheets, and other resources for providing miscarriage care can be found here.

Dr. Prine said she had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – "It’s not your fault."

Family physicians should relay those words of assurance to patients who present to them with early pregnancy loss, according to Dr. Linda Prine.

"In busy emergency rooms, that’s rarely the kind of thing an ER doc is going to have time to sit down and discuss with the patient," said Dr. Prine, women’s health director of the Institute for Family Health in New York. "They’re trying to make a diagnosis and move the patient on. Here you often have a woman who’s already thinking about what color she’s going to paint the bedroom, or buying a baby crib, or a stroller. This feels like a tragic loss to her. It needs to be explained gently as a natural process and some time taken for understanding. Her partner also needs to hear that it wasn’t her fault or his fault. It wasn’t the sex they had, the snow she shoveled – all of the things that start to go through a woman’s mind to blame herself."

Risk factors for miscarriage include advanced age or very young age, having prior miscarriages, smoking, cocaine use, and fever or infection. Contrary to myth, air travel does not cause miscarriage, she continued, and blunt abdominal trauma, contraceptive use, exercise, the human papillomavirus vaccine, previous abortions, and sexual activity are also not to blame.

Options for miscarriage include expectant management, medication management, and an aspiration procedure. "The patient should be involved in the decision making here," Dr. Prine said at the annual meeting of the American Academy of Family Physicians. "When the women are involved, their mental health outcomes are better. Family physicians are best suited to work through these events with our patients."

The potential risks of expectant management are rare but include infection, the need for emergent uterine aspiration, and bleeding or the need for blood transfusion. The benefits of expectant management include "avoiding the risks, though rare, that can happen with instrumentation such as perforation, introducing infection, or bleeding from a procedure that’s done too vigorously," she noted.

Fever with a tender uterus is a contraindication for expectant management. Incomplete abortions are more likely to have successful expectant management than are fetal demises or anembryonic pregnancies (at day 49, a success rate of 91% vs. 76% and 66%, respectively). "There’s no outside limit for how long you can wait for expectant management," Dr. Prine said. "Usually the woman is not going to want to wait for weeks and weeks, and that becomes the patient-centered limiting factor. How heavy can the bleeding get before she should start to worry about it? If she’s bleeding through two pads an hour for 2 hours back to back, she should call us, though this is rare."

For medical management of an early pregnancy loss, a common protocol involves 800 mcg misoprostol administered vaginally or buccally and repeated in 24 hours if the abortion is incomplete, with vacuum aspiration on day 8 if still incomplete. "Alternative oral regimens cause more GI side effects," Dr. Prine said. Side effects of misoprostol are bleeding, cramping, fever and/or chills, nausea and vomiting, and diarrhea. Misoprostol treatment is safest when used 10 weeks or less after an ultrasound exam confirming the pregnancy loss. "Rule out ectopic pregnancy because the medical treatment for ectopic pregnancy differs from miscarriage treatment," she said. Testing may include an ultrasound, an rh factor screen, hematocrit assessment, and measurement of the serum human chorionic gonadotropin level.

If medical management is not working, "we can repeat the misoprostol again, or she can come into the office for an aspiration procedure," Dr. Prine said.

Sample clinical protocols, patient education sheets, and other resources for providing miscarriage care can be found here.

Dr. Prine said she had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – "It’s not your fault."

Family physicians should relay those words of assurance to patients who present to them with early pregnancy loss, according to Dr. Linda Prine.

"In busy emergency rooms, that’s rarely the kind of thing an ER doc is going to have time to sit down and discuss with the patient," said Dr. Prine, women’s health director of the Institute for Family Health in New York. "They’re trying to make a diagnosis and move the patient on. Here you often have a woman who’s already thinking about what color she’s going to paint the bedroom, or buying a baby crib, or a stroller. This feels like a tragic loss to her. It needs to be explained gently as a natural process and some time taken for understanding. Her partner also needs to hear that it wasn’t her fault or his fault. It wasn’t the sex they had, the snow she shoveled – all of the things that start to go through a woman’s mind to blame herself."

Risk factors for miscarriage include advanced age or very young age, having prior miscarriages, smoking, cocaine use, and fever or infection. Contrary to myth, air travel does not cause miscarriage, she continued, and blunt abdominal trauma, contraceptive use, exercise, the human papillomavirus vaccine, previous abortions, and sexual activity are also not to blame.

Options for miscarriage include expectant management, medication management, and an aspiration procedure. "The patient should be involved in the decision making here," Dr. Prine said at the annual meeting of the American Academy of Family Physicians. "When the women are involved, their mental health outcomes are better. Family physicians are best suited to work through these events with our patients."

The potential risks of expectant management are rare but include infection, the need for emergent uterine aspiration, and bleeding or the need for blood transfusion. The benefits of expectant management include "avoiding the risks, though rare, that can happen with instrumentation such as perforation, introducing infection, or bleeding from a procedure that’s done too vigorously," she noted.

Fever with a tender uterus is a contraindication for expectant management. Incomplete abortions are more likely to have successful expectant management than are fetal demises or anembryonic pregnancies (at day 49, a success rate of 91% vs. 76% and 66%, respectively). "There’s no outside limit for how long you can wait for expectant management," Dr. Prine said. "Usually the woman is not going to want to wait for weeks and weeks, and that becomes the patient-centered limiting factor. How heavy can the bleeding get before she should start to worry about it? If she’s bleeding through two pads an hour for 2 hours back to back, she should call us, though this is rare."

For medical management of an early pregnancy loss, a common protocol involves 800 mcg misoprostol administered vaginally or buccally and repeated in 24 hours if the abortion is incomplete, with vacuum aspiration on day 8 if still incomplete. "Alternative oral regimens cause more GI side effects," Dr. Prine said. Side effects of misoprostol are bleeding, cramping, fever and/or chills, nausea and vomiting, and diarrhea. Misoprostol treatment is safest when used 10 weeks or less after an ultrasound exam confirming the pregnancy loss. "Rule out ectopic pregnancy because the medical treatment for ectopic pregnancy differs from miscarriage treatment," she said. Testing may include an ultrasound, an rh factor screen, hematocrit assessment, and measurement of the serum human chorionic gonadotropin level.

If medical management is not working, "we can repeat the misoprostol again, or she can come into the office for an aspiration procedure," Dr. Prine said.

Sample clinical protocols, patient education sheets, and other resources for providing miscarriage care can be found here.

Dr. Prine said she had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

The age-specific incidence of herpes zoster in the United States has been increasing in adults over age 65 even before implementation of the childhood varicella vaccination program, results from a retrospective study of Medicare data claims showed.

"Concern has been expressed that routine childhood varicella vaccination, introduced in the United States in 1996, could thereby lead to an increase in herpes zoster incidence by reducing opportunities for exposure to varicella," researchers led by Dr. Craig M. Hales reported. "Our findings suggest that, although herpes zoster incidence has increased in elderly persons, routine varicella vaccination has not influenced this increase." They characterized the information as "reassuring for countries considering universal varicella vaccination."

©Elsevier 2004. Habif: Clinical Dermatology 4E

Medicare claims data from 1992 through 2010 were examined to evaluate trends in herpes zoster incidence in people older than age 65 and to determine any influence of the varicella vaccination program on these trends (Ann. Intern. Med. 2013;159:739-45). The investigators, from the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, also examined the influence of age, gender, and race or ethnicity on herpes zoster incidence, which was defined as first occurrence of the condition in a given year in any health care setting according to International Classification of Diseases, Ninth Revision, Clinical Modification code.

From 1992 through 2010, a total of 281,317 cases of herpes zoster occurred among 2,845,353 Medicare beneficiaries. Their mean age was 76 years in 1992 and 77 years in 2010. After standardizing for age and gender, Dr. Hales and his associates found that herpes zoster incidence increased 39% from 10 per 1,000 person-years in 1992 to 13.9 per 1,000 person-years in 2010, but they did not detect evidence of a statistically significant change in the rate of increase after introduction of the varicella vaccination program in 1996.

From 1992 to 1996, the herpes zoster incidence was higher in women than in men (risk ratio, 1.21), and was lower in black and Hispanic people than in white people (RR, 0.51 and 0.76, respectively). In a model adjusted for gender, age, and calendar year from 1997 to 2010, the herpes zoster incidence did not vary by state varicella vaccination coverage (RR, 0.9998).

The researchers concluded that the study findings have several implications, including the fact that "in the absence of explanations for increasing herpes zoster incidence, properly monitoring the effect of the herpes zoster vaccination program or projecting future herpes zoster incidence will be difficult," they wrote. "Furthermore, herpes zoster poses a substantial burden of disease in the elderly population; continued increases in herpes zoster incidence would be worrisome and need to be understood."

The researchers stated that they had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

The age-specific incidence of herpes zoster in the United States has been increasing in adults over age 65 even before implementation of the childhood varicella vaccination program, results from a retrospective study of Medicare data claims showed.

"Concern has been expressed that routine childhood varicella vaccination, introduced in the United States in 1996, could thereby lead to an increase in herpes zoster incidence by reducing opportunities for exposure to varicella," researchers led by Dr. Craig M. Hales reported. "Our findings suggest that, although herpes zoster incidence has increased in elderly persons, routine varicella vaccination has not influenced this increase." They characterized the information as "reassuring for countries considering universal varicella vaccination."

©Elsevier 2004. Habif: Clinical Dermatology 4E

Medicare claims data from 1992 through 2010 were examined to evaluate trends in herpes zoster incidence in people older than age 65 and to determine any influence of the varicella vaccination program on these trends (Ann. Intern. Med. 2013;159:739-45). The investigators, from the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, also examined the influence of age, gender, and race or ethnicity on herpes zoster incidence, which was defined as first occurrence of the condition in a given year in any health care setting according to International Classification of Diseases, Ninth Revision, Clinical Modification code.

From 1992 through 2010, a total of 281,317 cases of herpes zoster occurred among 2,845,353 Medicare beneficiaries. Their mean age was 76 years in 1992 and 77 years in 2010. After standardizing for age and gender, Dr. Hales and his associates found that herpes zoster incidence increased 39% from 10 per 1,000 person-years in 1992 to 13.9 per 1,000 person-years in 2010, but they did not detect evidence of a statistically significant change in the rate of increase after introduction of the varicella vaccination program in 1996.

From 1992 to 1996, the herpes zoster incidence was higher in women than in men (risk ratio, 1.21), and was lower in black and Hispanic people than in white people (RR, 0.51 and 0.76, respectively). In a model adjusted for gender, age, and calendar year from 1997 to 2010, the herpes zoster incidence did not vary by state varicella vaccination coverage (RR, 0.9998).

The researchers concluded that the study findings have several implications, including the fact that "in the absence of explanations for increasing herpes zoster incidence, properly monitoring the effect of the herpes zoster vaccination program or projecting future herpes zoster incidence will be difficult," they wrote. "Furthermore, herpes zoster poses a substantial burden of disease in the elderly population; continued increases in herpes zoster incidence would be worrisome and need to be understood."

The researchers stated that they had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

The age-specific incidence of herpes zoster in the United States has been increasing in adults over age 65 even before implementation of the childhood varicella vaccination program, results from a retrospective study of Medicare data claims showed.

"Concern has been expressed that routine childhood varicella vaccination, introduced in the United States in 1996, could thereby lead to an increase in herpes zoster incidence by reducing opportunities for exposure to varicella," researchers led by Dr. Craig M. Hales reported. "Our findings suggest that, although herpes zoster incidence has increased in elderly persons, routine varicella vaccination has not influenced this increase." They characterized the information as "reassuring for countries considering universal varicella vaccination."

©Elsevier 2004. Habif: Clinical Dermatology 4E

Medicare claims data from 1992 through 2010 were examined to evaluate trends in herpes zoster incidence in people older than age 65 and to determine any influence of the varicella vaccination program on these trends (Ann. Intern. Med. 2013;159:739-45). The investigators, from the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, also examined the influence of age, gender, and race or ethnicity on herpes zoster incidence, which was defined as first occurrence of the condition in a given year in any health care setting according to International Classification of Diseases, Ninth Revision, Clinical Modification code.

From 1992 through 2010, a total of 281,317 cases of herpes zoster occurred among 2,845,353 Medicare beneficiaries. Their mean age was 76 years in 1992 and 77 years in 2010. After standardizing for age and gender, Dr. Hales and his associates found that herpes zoster incidence increased 39% from 10 per 1,000 person-years in 1992 to 13.9 per 1,000 person-years in 2010, but they did not detect evidence of a statistically significant change in the rate of increase after introduction of the varicella vaccination program in 1996.

From 1992 to 1996, the herpes zoster incidence was higher in women than in men (risk ratio, 1.21), and was lower in black and Hispanic people than in white people (RR, 0.51 and 0.76, respectively). In a model adjusted for gender, age, and calendar year from 1997 to 2010, the herpes zoster incidence did not vary by state varicella vaccination coverage (RR, 0.9998).

The researchers concluded that the study findings have several implications, including the fact that "in the absence of explanations for increasing herpes zoster incidence, properly monitoring the effect of the herpes zoster vaccination program or projecting future herpes zoster incidence will be difficult," they wrote. "Furthermore, herpes zoster poses a substantial burden of disease in the elderly population; continued increases in herpes zoster incidence would be worrisome and need to be understood."

The researchers stated that they had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

The National Institutes of Health announced on Dec. 16 significant financial support for eight research projects focused on traumatic brain injury, which currently ranks as the leading cause of death in young adults.

"We need to be able to predict which patterns of injury are rapidly reversible and which are not," Story Landis, Ph.D., director of the National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH, said in a prepared statement. "This program will help researchers get closer to answering some of the important questions about concussion for our youth who play sports and their parents."

Funding, which totals more than $14 million, comes from the Sports and Health Research Program, a partnership between the NIH, the National Football League, and the Foundation for the National Institutes of Health. The eight projects earmarked to receive support include two cooperative agreements and six pilot studies.

For one of the two cooperative agreements, which will receive $6 million each, researchers led by Dr. Ann C. McKee of Boston University and the U.S. Department of Veterans Affairs will strive to define a set of criteria for the various stages of chronic traumatic encephalopathy (CTE). Then, imaging teams will correlate the findings with brain scans that might be used to diagnose CTE in individuals during their lifetimes. For the other cooperative agreement, researchers led by Wayne Gordon, Ph.D., of Mount Sinai Hospital, New York, have a goal of identifying and describing the chronic effects of mild, moderate, and severe traumatic brain injuries (TBIs) and comparing these with the features of CTE. Then, they will employ various brain imaging techniques in patients with a wide range of head injuries, as well as on postmortem tissue, to identify markers that may eventually be used to diagnose the degenerative effects of TBI.

"Although the two cooperative agreements focus on different aspects of TBI, their combined results promise to answer critical questions about the chronic effects of single versus repetitive injuries on the brain, how repetitive TBI might lead to CTE, how commonly these changes occur in an adult population, and how CTE relates to neurodegenerative disorders like Alzheimer’s disease," Dr. Landis said.

The six pilot studies, which are projected to receive just over $2 million in total funding, focus on ways to improve the diagnosis of concussion and identify potential biomarkers that can be used to track a patient’s recovery. They range from testing of a mobile application designed to track the progress of a young athlete from the time of a concussion injury until they are cleared to return to play, to the development of a portable eye-tracking instrument that can be used to diagnose concussions on the sidelines and to monitor the injury progression in high school and college athletes.

dbrunk@frontlinemedcom.com

The National Institutes of Health announced on Dec. 16 significant financial support for eight research projects focused on traumatic brain injury, which currently ranks as the leading cause of death in young adults.

"We need to be able to predict which patterns of injury are rapidly reversible and which are not," Story Landis, Ph.D., director of the National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH, said in a prepared statement. "This program will help researchers get closer to answering some of the important questions about concussion for our youth who play sports and their parents."

Funding, which totals more than $14 million, comes from the Sports and Health Research Program, a partnership between the NIH, the National Football League, and the Foundation for the National Institutes of Health. The eight projects earmarked to receive support include two cooperative agreements and six pilot studies.

For one of the two cooperative agreements, which will receive $6 million each, researchers led by Dr. Ann C. McKee of Boston University and the U.S. Department of Veterans Affairs will strive to define a set of criteria for the various stages of chronic traumatic encephalopathy (CTE). Then, imaging teams will correlate the findings with brain scans that might be used to diagnose CTE in individuals during their lifetimes. For the other cooperative agreement, researchers led by Wayne Gordon, Ph.D., of Mount Sinai Hospital, New York, have a goal of identifying and describing the chronic effects of mild, moderate, and severe traumatic brain injuries (TBIs) and comparing these with the features of CTE. Then, they will employ various brain imaging techniques in patients with a wide range of head injuries, as well as on postmortem tissue, to identify markers that may eventually be used to diagnose the degenerative effects of TBI.

"Although the two cooperative agreements focus on different aspects of TBI, their combined results promise to answer critical questions about the chronic effects of single versus repetitive injuries on the brain, how repetitive TBI might lead to CTE, how commonly these changes occur in an adult population, and how CTE relates to neurodegenerative disorders like Alzheimer’s disease," Dr. Landis said.

The six pilot studies, which are projected to receive just over $2 million in total funding, focus on ways to improve the diagnosis of concussion and identify potential biomarkers that can be used to track a patient’s recovery. They range from testing of a mobile application designed to track the progress of a young athlete from the time of a concussion injury until they are cleared to return to play, to the development of a portable eye-tracking instrument that can be used to diagnose concussions on the sidelines and to monitor the injury progression in high school and college athletes.

dbrunk@frontlinemedcom.com

The National Institutes of Health announced on Dec. 16 significant financial support for eight research projects focused on traumatic brain injury, which currently ranks as the leading cause of death in young adults.

"We need to be able to predict which patterns of injury are rapidly reversible and which are not," Story Landis, Ph.D., director of the National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH, said in a prepared statement. "This program will help researchers get closer to answering some of the important questions about concussion for our youth who play sports and their parents."

Funding, which totals more than $14 million, comes from the Sports and Health Research Program, a partnership between the NIH, the National Football League, and the Foundation for the National Institutes of Health. The eight projects earmarked to receive support include two cooperative agreements and six pilot studies.

For one of the two cooperative agreements, which will receive $6 million each, researchers led by Dr. Ann C. McKee of Boston University and the U.S. Department of Veterans Affairs will strive to define a set of criteria for the various stages of chronic traumatic encephalopathy (CTE). Then, imaging teams will correlate the findings with brain scans that might be used to diagnose CTE in individuals during their lifetimes. For the other cooperative agreement, researchers led by Wayne Gordon, Ph.D., of Mount Sinai Hospital, New York, have a goal of identifying and describing the chronic effects of mild, moderate, and severe traumatic brain injuries (TBIs) and comparing these with the features of CTE. Then, they will employ various brain imaging techniques in patients with a wide range of head injuries, as well as on postmortem tissue, to identify markers that may eventually be used to diagnose the degenerative effects of TBI.

"Although the two cooperative agreements focus on different aspects of TBI, their combined results promise to answer critical questions about the chronic effects of single versus repetitive injuries on the brain, how repetitive TBI might lead to CTE, how commonly these changes occur in an adult population, and how CTE relates to neurodegenerative disorders like Alzheimer’s disease," Dr. Landis said.

The six pilot studies, which are projected to receive just over $2 million in total funding, focus on ways to improve the diagnosis of concussion and identify potential biomarkers that can be used to track a patient’s recovery. They range from testing of a mobile application designed to track the progress of a young athlete from the time of a concussion injury until they are cleared to return to play, to the development of a portable eye-tracking instrument that can be used to diagnose concussions on the sidelines and to monitor the injury progression in high school and college athletes.

dbrunk@frontlinemedcom.com

LAS VEGAS – Urinary tract injury occurs in an estimated 1.3% of laparoscopic hysterectomies, with ureteral injuries about as common as bladder injuries, results from large analysis of HMO patients showed.

"Given the rising popularity of minimally invasive surgery, laparoscopic hysterectomy has emerged as one of the modalities of choice for benign gynecologic hysterectomies," Dr. Jasmine Tan-Kim said in a poster presented at the annual meeting of the American Urogynecologic Society. "This increase in popularity is largely attributable to the decreased pain, length of hospital stay, and shorter postoperative recovery when compared to abdominal hysterectomy."

In an effort to evaluate the incidence, detection, and characteristics of urinary tract injury with total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy, Dr. Kim and her associates retrospectively analyzed data from 3,523 patients who underwent laparoscopic hysterectomy at Kaiser Permanente San Diego Medical Center from 2001 to 2012. They collected demographic characteristics, surgical techniques, and intra- and post-operative complications, using multivariable logistic regression to assess the independent risk factors for ureteral or bladder injury.

The mean age of patients was 46 years, their median body mass index was 29 kg/m², and 20% had intraoperative cystoscopy.

The overall incidence of urinary tract injury was 1.3%. Of the 46 injuries, 19 (0.54%) were ureteral, 25 (0.71%) were bladder injuries, and two (0.06%) were both, reported Dr. Kim of the division of female pelvic medicine and reconstructive surgery at Kaiser Permanente, San Diego.

In more than half (57%) of urinary tract injury cases, the repair was performed by gynecologists, gynecologic oncologists, or urogynecologists, while the remainder (43%) were performed by urologists. There was no difference between total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy in terms of risk of ureteral or bladder injury, Dr. Kim said.

Of the 21 ureteral injuries, 71% were diagnosed postoperatively and 29% were diagnosed intraoperatively. Of the 27 bladder injuries, 85% were identified intraoperatively and 15% were identified postoperatively.

The regression analysis revealed that risk factors significantly associated with ureteral injury were a BMI of 26-30 kg/m² (odds ratio, 4.07) and African American ethnicity (OR, 3.14). Risk factors significantly associated with bladder injury were BMI less than 26 kg/m² (OR, 3.86), presence of endometriosis (OR, 2.85), and nulliparity (OR, 0.27 for no deliveries vs. two deliveries and OR, 0.11 for no deliveries vs. three or more deliveries).

The researchers stated that they had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

LAS VEGAS – Urinary tract injury occurs in an estimated 1.3% of laparoscopic hysterectomies, with ureteral injuries about as common as bladder injuries, results from large analysis of HMO patients showed.

"Given the rising popularity of minimally invasive surgery, laparoscopic hysterectomy has emerged as one of the modalities of choice for benign gynecologic hysterectomies," Dr. Jasmine Tan-Kim said in a poster presented at the annual meeting of the American Urogynecologic Society. "This increase in popularity is largely attributable to the decreased pain, length of hospital stay, and shorter postoperative recovery when compared to abdominal hysterectomy."

In an effort to evaluate the incidence, detection, and characteristics of urinary tract injury with total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy, Dr. Kim and her associates retrospectively analyzed data from 3,523 patients who underwent laparoscopic hysterectomy at Kaiser Permanente San Diego Medical Center from 2001 to 2012. They collected demographic characteristics, surgical techniques, and intra- and post-operative complications, using multivariable logistic regression to assess the independent risk factors for ureteral or bladder injury.

The mean age of patients was 46 years, their median body mass index was 29 kg/m², and 20% had intraoperative cystoscopy.

The overall incidence of urinary tract injury was 1.3%. Of the 46 injuries, 19 (0.54%) were ureteral, 25 (0.71%) were bladder injuries, and two (0.06%) were both, reported Dr. Kim of the division of female pelvic medicine and reconstructive surgery at Kaiser Permanente, San Diego.

In more than half (57%) of urinary tract injury cases, the repair was performed by gynecologists, gynecologic oncologists, or urogynecologists, while the remainder (43%) were performed by urologists. There was no difference between total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy in terms of risk of ureteral or bladder injury, Dr. Kim said.

Of the 21 ureteral injuries, 71% were diagnosed postoperatively and 29% were diagnosed intraoperatively. Of the 27 bladder injuries, 85% were identified intraoperatively and 15% were identified postoperatively.

The regression analysis revealed that risk factors significantly associated with ureteral injury were a BMI of 26-30 kg/m² (odds ratio, 4.07) and African American ethnicity (OR, 3.14). Risk factors significantly associated with bladder injury were BMI less than 26 kg/m² (OR, 3.86), presence of endometriosis (OR, 2.85), and nulliparity (OR, 0.27 for no deliveries vs. two deliveries and OR, 0.11 for no deliveries vs. three or more deliveries).

The researchers stated that they had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

LAS VEGAS – Urinary tract injury occurs in an estimated 1.3% of laparoscopic hysterectomies, with ureteral injuries about as common as bladder injuries, results from large analysis of HMO patients showed.

"Given the rising popularity of minimally invasive surgery, laparoscopic hysterectomy has emerged as one of the modalities of choice for benign gynecologic hysterectomies," Dr. Jasmine Tan-Kim said in a poster presented at the annual meeting of the American Urogynecologic Society. "This increase in popularity is largely attributable to the decreased pain, length of hospital stay, and shorter postoperative recovery when compared to abdominal hysterectomy."

In an effort to evaluate the incidence, detection, and characteristics of urinary tract injury with total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy, Dr. Kim and her associates retrospectively analyzed data from 3,523 patients who underwent laparoscopic hysterectomy at Kaiser Permanente San Diego Medical Center from 2001 to 2012. They collected demographic characteristics, surgical techniques, and intra- and post-operative complications, using multivariable logistic regression to assess the independent risk factors for ureteral or bladder injury.

The mean age of patients was 46 years, their median body mass index was 29 kg/m², and 20% had intraoperative cystoscopy.

The overall incidence of urinary tract injury was 1.3%. Of the 46 injuries, 19 (0.54%) were ureteral, 25 (0.71%) were bladder injuries, and two (0.06%) were both, reported Dr. Kim of the division of female pelvic medicine and reconstructive surgery at Kaiser Permanente, San Diego.

In more than half (57%) of urinary tract injury cases, the repair was performed by gynecologists, gynecologic oncologists, or urogynecologists, while the remainder (43%) were performed by urologists. There was no difference between total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy in terms of risk of ureteral or bladder injury, Dr. Kim said.

Of the 21 ureteral injuries, 71% were diagnosed postoperatively and 29% were diagnosed intraoperatively. Of the 27 bladder injuries, 85% were identified intraoperatively and 15% were identified postoperatively.

The regression analysis revealed that risk factors significantly associated with ureteral injury were a BMI of 26-30 kg/m² (odds ratio, 4.07) and African American ethnicity (OR, 3.14). Risk factors significantly associated with bladder injury were BMI less than 26 kg/m² (OR, 3.86), presence of endometriosis (OR, 2.85), and nulliparity (OR, 0.27 for no deliveries vs. two deliveries and OR, 0.11 for no deliveries vs. three or more deliveries).

The researchers stated that they had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – Patients recently diagnosed with Alzheimer’s disease had an increased prevalence of diagnoses for neuropsychiatric conditions that mimic symptoms of mild cognitive impairment in a large retrospective, case-control study.

The findings underscore the need for an instrument designed to help clinicians differentiate mild cognitive impairment (MCI) from other neuropsychiatric conditions, Jiao Yang, Ph.D., said in an interview at the Clinical Trials Conference on Alzheimer’s Disease.

"We need a better guidance for clinical practice," said Dr. Yang, a project statistician with Deerfield, Ill.–based Takeda Pharmaceuticals International. "We do need some type of a diagnostic test to differentiate or to detect MCI."

In an effort to characterize the 3-year period immediately preceding the first diagnosis of Alzheimer’s disease (AD) and the first 6 months after diagnosis, Dr. Yang and her associates used data from the 2010-2011 Truven Health Analytics MarketScan Commercial and Medicare Supplemental Database to identify risk and prognostic factors in 28,879 newly diagnosed AD patients with a mean age of 79 years. The researchers also randomly selected a control cohort of 28,879 patients, excluding those with dementia or taking AD medications, and matched them in a 1:1 fashion with the AD cohort on age, gender, insurance plan type, and geographic region.

The percentage of AD patients, compared with controls, who had a diagnosis of MCI at 36 months before AD diagnosis to 6 months before AD diagnosis to 6 months after AD diagnosis increased from 0.2% to 5.2% to 7.6%, compared with controls (0% at all three time points). The same significant trend occurred for diagnoses of AD-related conditions or dementias or frontotemporal dementia, dementia with Lewy bodies, and memory loss (from 1.9% to 36.2% to 48.2% for AD patients and from 0.2% to 1.1% to 1.4% for controls) and various neurologic disorders (from 5.4% to 26.4% to 31.9% for AD patients and from 1.1% to 4.2% to 4.9% for controls).

"The steeper slope of the increase in prevalence in the 6 months pre-index period seems to suggest that diagnosis of these disorders may lead a physician to test for AD, while the 6 months post-index increase could indicate higher awareness among physicians of the need to test AD patients for other similar diagnoses," Dr. Yang said.

Over time, a higher percentage of AD patients vs. controls also had anxiety disorder (from 2.4% to 6.6% to 6.5% vs. from 1.1% to 1.7% to 1.9%) and depression (from 4.6% to 11.1% to 11.6% vs. from 1.4% to 2.0% to 2.3%). The percentage of patients with cerebrovascular disease also increased with time (from 8.3% to 41.8% to 47.5% for AD patients and from 5.1% to 19.9% to 22.4% for controls), as did the percentage of patients with congestive heart failure (from 3.7% to 16.5% to 19.4% for AD patients and from 2.9% to 11.4% to 13.0% for controls).

The researchers also noted that, at each subsequent interval, a higher proportion of AD patients were using antidepressants, tranquilizers/antipsychotics, and benzodiazepines, compared with controls. In addition, 37.2% of MCI patients were primarily first diagnosed by neurologists, "possibly highlighting the difficulty of making the diagnosis," she noted in the poster presentation. "This could be due to the lack of tests or procedures to demonstrate conclusively the presence of MCI."

Takeda Pharmaceuticals International sponsored the study.

dbrunk@frontlinemedcom.com

SAN DIEGO – Patients recently diagnosed with Alzheimer’s disease had an increased prevalence of diagnoses for neuropsychiatric conditions that mimic symptoms of mild cognitive impairment in a large retrospective, case-control study.

The findings underscore the need for an instrument designed to help clinicians differentiate mild cognitive impairment (MCI) from other neuropsychiatric conditions, Jiao Yang, Ph.D., said in an interview at the Clinical Trials Conference on Alzheimer’s Disease.

"We need a better guidance for clinical practice," said Dr. Yang, a project statistician with Deerfield, Ill.–based Takeda Pharmaceuticals International. "We do need some type of a diagnostic test to differentiate or to detect MCI."

In an effort to characterize the 3-year period immediately preceding the first diagnosis of Alzheimer’s disease (AD) and the first 6 months after diagnosis, Dr. Yang and her associates used data from the 2010-2011 Truven Health Analytics MarketScan Commercial and Medicare Supplemental Database to identify risk and prognostic factors in 28,879 newly diagnosed AD patients with a mean age of 79 years. The researchers also randomly selected a control cohort of 28,879 patients, excluding those with dementia or taking AD medications, and matched them in a 1:1 fashion with the AD cohort on age, gender, insurance plan type, and geographic region.

The percentage of AD patients, compared with controls, who had a diagnosis of MCI at 36 months before AD diagnosis to 6 months before AD diagnosis to 6 months after AD diagnosis increased from 0.2% to 5.2% to 7.6%, compared with controls (0% at all three time points). The same significant trend occurred for diagnoses of AD-related conditions or dementias or frontotemporal dementia, dementia with Lewy bodies, and memory loss (from 1.9% to 36.2% to 48.2% for AD patients and from 0.2% to 1.1% to 1.4% for controls) and various neurologic disorders (from 5.4% to 26.4% to 31.9% for AD patients and from 1.1% to 4.2% to 4.9% for controls).

"The steeper slope of the increase in prevalence in the 6 months pre-index period seems to suggest that diagnosis of these disorders may lead a physician to test for AD, while the 6 months post-index increase could indicate higher awareness among physicians of the need to test AD patients for other similar diagnoses," Dr. Yang said.

Over time, a higher percentage of AD patients vs. controls also had anxiety disorder (from 2.4% to 6.6% to 6.5% vs. from 1.1% to 1.7% to 1.9%) and depression (from 4.6% to 11.1% to 11.6% vs. from 1.4% to 2.0% to 2.3%). The percentage of patients with cerebrovascular disease also increased with time (from 8.3% to 41.8% to 47.5% for AD patients and from 5.1% to 19.9% to 22.4% for controls), as did the percentage of patients with congestive heart failure (from 3.7% to 16.5% to 19.4% for AD patients and from 2.9% to 11.4% to 13.0% for controls).

The researchers also noted that, at each subsequent interval, a higher proportion of AD patients were using antidepressants, tranquilizers/antipsychotics, and benzodiazepines, compared with controls. In addition, 37.2% of MCI patients were primarily first diagnosed by neurologists, "possibly highlighting the difficulty of making the diagnosis," she noted in the poster presentation. "This could be due to the lack of tests or procedures to demonstrate conclusively the presence of MCI."

Takeda Pharmaceuticals International sponsored the study.

dbrunk@frontlinemedcom.com

SAN DIEGO – Patients recently diagnosed with Alzheimer’s disease had an increased prevalence of diagnoses for neuropsychiatric conditions that mimic symptoms of mild cognitive impairment in a large retrospective, case-control study.

The findings underscore the need for an instrument designed to help clinicians differentiate mild cognitive impairment (MCI) from other neuropsychiatric conditions, Jiao Yang, Ph.D., said in an interview at the Clinical Trials Conference on Alzheimer’s Disease.

"We need a better guidance for clinical practice," said Dr. Yang, a project statistician with Deerfield, Ill.–based Takeda Pharmaceuticals International. "We do need some type of a diagnostic test to differentiate or to detect MCI."

In an effort to characterize the 3-year period immediately preceding the first diagnosis of Alzheimer’s disease (AD) and the first 6 months after diagnosis, Dr. Yang and her associates used data from the 2010-2011 Truven Health Analytics MarketScan Commercial and Medicare Supplemental Database to identify risk and prognostic factors in 28,879 newly diagnosed AD patients with a mean age of 79 years. The researchers also randomly selected a control cohort of 28,879 patients, excluding those with dementia or taking AD medications, and matched them in a 1:1 fashion with the AD cohort on age, gender, insurance plan type, and geographic region.

The percentage of AD patients, compared with controls, who had a diagnosis of MCI at 36 months before AD diagnosis to 6 months before AD diagnosis to 6 months after AD diagnosis increased from 0.2% to 5.2% to 7.6%, compared with controls (0% at all three time points). The same significant trend occurred for diagnoses of AD-related conditions or dementias or frontotemporal dementia, dementia with Lewy bodies, and memory loss (from 1.9% to 36.2% to 48.2% for AD patients and from 0.2% to 1.1% to 1.4% for controls) and various neurologic disorders (from 5.4% to 26.4% to 31.9% for AD patients and from 1.1% to 4.2% to 4.9% for controls).

"The steeper slope of the increase in prevalence in the 6 months pre-index period seems to suggest that diagnosis of these disorders may lead a physician to test for AD, while the 6 months post-index increase could indicate higher awareness among physicians of the need to test AD patients for other similar diagnoses," Dr. Yang said.

Over time, a higher percentage of AD patients vs. controls also had anxiety disorder (from 2.4% to 6.6% to 6.5% vs. from 1.1% to 1.7% to 1.9%) and depression (from 4.6% to 11.1% to 11.6% vs. from 1.4% to 2.0% to 2.3%). The percentage of patients with cerebrovascular disease also increased with time (from 8.3% to 41.8% to 47.5% for AD patients and from 5.1% to 19.9% to 22.4% for controls), as did the percentage of patients with congestive heart failure (from 3.7% to 16.5% to 19.4% for AD patients and from 2.9% to 11.4% to 13.0% for controls).

The researchers also noted that, at each subsequent interval, a higher proportion of AD patients were using antidepressants, tranquilizers/antipsychotics, and benzodiazepines, compared with controls. In addition, 37.2% of MCI patients were primarily first diagnosed by neurologists, "possibly highlighting the difficulty of making the diagnosis," she noted in the poster presentation. "This could be due to the lack of tests or procedures to demonstrate conclusively the presence of MCI."

Takeda Pharmaceuticals International sponsored the study.

dbrunk@frontlinemedcom.com

LAS VEGAS – Obese women report significantly greater lower urinary tract symptoms and worse overall quality of life than do obese men, results from a single-center study showed.

"Over one-third of U.S. adults are obese and 60% are considered overweight," Dr. Margarita M. Aponte said in a poster presented during the annual meeting of the American Urogynecologic Society. "In women, obesity is an independent risk factor for pelvic floor disorders, and in men, obesity has been associated with an increase in storage symptoms and benign prostatic hypertrophy."

Dr. Aponte and her associates at New York University Langone Medical Center recruited 134 men and women who were planning to undergo laparoscopic-assisted gastric banding (LAGB). They collected demographic information and clinical data, and administered validated questionnaires preoperatively, including the Overactive Bladder Questionnaire (OAB-q), the International Consultation on Incontinence Questionnaire–Short Form (ICIQ-SF), the Medical, Epidemiologic and Social aspects of Aging (MESA) scale, and the International Prostate Symptom Score (IPSS), to evaluate lower urinary tract symptoms. The investigators also evaluated quality of life preoperatively with the King’s Health Questionnaire (KHQ). The purpose was to characterize and differentiate baseline lower urinary tract symptoms and quality of life scores in obese men and women who were undergoing LAGB.

Of the 134 patients, 92 (69%) were women and their mean age was 42 years. The researchers reported that on the OAB-Q, women had higher scores in symptom severity (P = .036), concern (P = .002), and health-related quality of life (P = .028) than did men. Increasing body mass index (BMI) was associated with greater concern (P = .024), social effects (P = .021), and total health-related quality of life scores (P = .051). Increasing age and having diabetes were associated with higher scores in almost all OAB-Q domains.

Compared with men, women also had a higher total International Consultation on Incontinence Questionnaire–Short Form score (P = .000) and International Prostate Symptom Score (P = .008), and increasing BMI was associated with incontinence severity in the ICIQ (P = .01).

On the King’s Health Questionnaire, women had higher scores in incontinence impact (P = .045), role limitations (P = .016), and severity (P = .000). Increasing BMI was associated with poor general health perception (P = .006), increased role limitations (P = .005), and severity (P = .002). In men, no association was observed between obesity, age, or the presence of diabetes and any of the KHQ domains.

The researchers said they had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

LAS VEGAS – Obese women report significantly greater lower urinary tract symptoms and worse overall quality of life than do obese men, results from a single-center study showed.

"Over one-third of U.S. adults are obese and 60% are considered overweight," Dr. Margarita M. Aponte said in a poster presented during the annual meeting of the American Urogynecologic Society. "In women, obesity is an independent risk factor for pelvic floor disorders, and in men, obesity has been associated with an increase in storage symptoms and benign prostatic hypertrophy."

Dr. Aponte and her associates at New York University Langone Medical Center recruited 134 men and women who were planning to undergo laparoscopic-assisted gastric banding (LAGB). They collected demographic information and clinical data, and administered validated questionnaires preoperatively, including the Overactive Bladder Questionnaire (OAB-q), the International Consultation on Incontinence Questionnaire–Short Form (ICIQ-SF), the Medical, Epidemiologic and Social aspects of Aging (MESA) scale, and the International Prostate Symptom Score (IPSS), to evaluate lower urinary tract symptoms. The investigators also evaluated quality of life preoperatively with the King’s Health Questionnaire (KHQ). The purpose was to characterize and differentiate baseline lower urinary tract symptoms and quality of life scores in obese men and women who were undergoing LAGB.

Of the 134 patients, 92 (69%) were women and their mean age was 42 years. The researchers reported that on the OAB-Q, women had higher scores in symptom severity (P = .036), concern (P = .002), and health-related quality of life (P = .028) than did men. Increasing body mass index (BMI) was associated with greater concern (P = .024), social effects (P = .021), and total health-related quality of life scores (P = .051). Increasing age and having diabetes were associated with higher scores in almost all OAB-Q domains.

Compared with men, women also had a higher total International Consultation on Incontinence Questionnaire–Short Form score (P = .000) and International Prostate Symptom Score (P = .008), and increasing BMI was associated with incontinence severity in the ICIQ (P = .01).

On the King’s Health Questionnaire, women had higher scores in incontinence impact (P = .045), role limitations (P = .016), and severity (P = .000). Increasing BMI was associated with poor general health perception (P = .006), increased role limitations (P = .005), and severity (P = .002). In men, no association was observed between obesity, age, or the presence of diabetes and any of the KHQ domains.

The researchers said they had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

LAS VEGAS – Obese women report significantly greater lower urinary tract symptoms and worse overall quality of life than do obese men, results from a single-center study showed.

"Over one-third of U.S. adults are obese and 60% are considered overweight," Dr. Margarita M. Aponte said in a poster presented during the annual meeting of the American Urogynecologic Society. "In women, obesity is an independent risk factor for pelvic floor disorders, and in men, obesity has been associated with an increase in storage symptoms and benign prostatic hypertrophy."

Dr. Aponte and her associates at New York University Langone Medical Center recruited 134 men and women who were planning to undergo laparoscopic-assisted gastric banding (LAGB). They collected demographic information and clinical data, and administered validated questionnaires preoperatively, including the Overactive Bladder Questionnaire (OAB-q), the International Consultation on Incontinence Questionnaire–Short Form (ICIQ-SF), the Medical, Epidemiologic and Social aspects of Aging (MESA) scale, and the International Prostate Symptom Score (IPSS), to evaluate lower urinary tract symptoms. The investigators also evaluated quality of life preoperatively with the King’s Health Questionnaire (KHQ). The purpose was to characterize and differentiate baseline lower urinary tract symptoms and quality of life scores in obese men and women who were undergoing LAGB.

Of the 134 patients, 92 (69%) were women and their mean age was 42 years. The researchers reported that on the OAB-Q, women had higher scores in symptom severity (P = .036), concern (P = .002), and health-related quality of life (P = .028) than did men. Increasing body mass index (BMI) was associated with greater concern (P = .024), social effects (P = .021), and total health-related quality of life scores (P = .051). Increasing age and having diabetes were associated with higher scores in almost all OAB-Q domains.

Compared with men, women also had a higher total International Consultation on Incontinence Questionnaire–Short Form score (P = .000) and International Prostate Symptom Score (P = .008), and increasing BMI was associated with incontinence severity in the ICIQ (P = .01).

On the King’s Health Questionnaire, women had higher scores in incontinence impact (P = .045), role limitations (P = .016), and severity (P = .000). Increasing BMI was associated with poor general health perception (P = .006), increased role limitations (P = .005), and severity (P = .002). In men, no association was observed between obesity, age, or the presence of diabetes and any of the KHQ domains.

The researchers said they had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

LAS VEGAS – Application of vaginal estrogen cream 6 weeks before undergoing hysterectomy resulted in increased thickness of both the vaginal epithelium and the muscularis, results of a randomized trial showed.

"Surgical repair remains the mainstay treatment for symptomatic prolapse," Dr. David D. Rahn said at the annual meeting of the American Urogynecologic Society. "Despite advances in surgical techniques, reoperation for recurrent prolapse is common. Clearly, there are significant trade-offs to adding graft material to surgical repairs. Given that our population is aging, there will be more women requiring surgical management of prolapse. Therefore, there’s a need to identify adjuncts to native tissue prolapse repairs that may minimize recurrent disease or lessen the likelihood of graft-associated complications."

Both basic science and clinical investigations indicate that estrogen plays an important role in the function of supportive connective tissues at the pelvic floor, said Dr. Rahn of the department of obstetrics and gynecology at the University of Texas Southwestern Medical Center, Dallas. However, clinical research regarding the effects of systemic hormone therapy on prevention or treatment of prolapse "has led to contradictory findings, with some studies suggesting a protective effect while others demonstrating either no difference or perhaps higher rates of prolapse in women using hormone therapy."

To determine the effects of vaginal estrogen on collagen synthesis in connective tissues of the vaginal muscularis and mucosa in postmenopausal women, Dr. Rahn and his associates enrolled 30 women who were 1-10 year postmenopausal with at least stage 2 anterior or apical prolapse planning total hysterectomy as part of a surgical repair. They excluded women with a body mass index of greater than 35 kg/m², current users of tobacco or steroids, and those with a vaginal infection. Of the 30 patients, 15 were randomized to receive Premarin, a conjugated estrogens cream, while the remaining 15 received placebo cream. "They were instructed to apply 1 g using the plastic applicator nightly for 2 weeks and then twice weekly for 4 more weeks until surgery," Dr. Rahn said. "A computer-generated randomization table was used to allocate patients to one of the treatment groups. Only the pharmacist remained unblinded to treatment allocation."

The researchers performed histomorphology, quantitative polymerase chain reaction, hydroxyproline assays, and immunoblot analyses to evaluate vaginal epithelium and muscularis from standardized full thickness anterior vaginal cuff biopsies obtained at the time of surgery. Zymography was used to assess matrix metalloproteinase (MMP) activity.

Full biopsy data were available from 12 patients in each arm. Dr. Rahn reported that their mean age was 57 years, slightly more than half (57%) were Hispanic, and their mean BMI was 30.5 kg/m². On histological assessment, the epithelial and the muscularis layer were thicker among samples from women treated with estrogen. Specifically, mean epithelial thickness was increased 1.8-fold in the estrogen group, while the muscularis thickness was increased 2.7-fold.

To determine if these estrogen-induced increases in muscularis thickness were associated with increased collagen synthesis, relative messenger RNA levels of collagen type I, alpha-1, type I, alpha-2, and collagen type III mRNA were quantified in the muscularis samples from both groups. Collagen I, alpha-1 was increased sixfold in the vaginal muscularis in the estrogen group, while collagen type I, alpha-2 and collagen type III mRNA were increased 1.8- and 2.5-fold, respectively.

Immunoblot analysis was completed in four patients in each treatment group who had sufficient tissue for protein analysis. Collagen type 1a monomers, dimers, and trimers were all increased 10-fold in the muscularis from samples of women treated with estrogen. In contrast, differences in collagen 3 protein were not significant. Further, with respect to matrix degradation, in patients adherent with local estrogen, human macrophage elastase mRNA was suppressed in the vaginal mucosa from estrogen-treated participants, and MMP-9 activity was decreased 6-fold in the mucosa and 4-fold in the muscularis. There was no change in expression of several protease inhibitors.

"Our findings from this trial suggest that 6 weeks of preoperative vaginal estrogen in postmenopausal women with prolapse may improve the substrate for suture placement at the time of repair while mitigating surgical induction of several degradative enzymes," Dr. Rahn concluded.

The study was funded by an Astellas Research Award/AUGS Foundation grant. Dr. Rahn said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

LAS VEGAS – Application of vaginal estrogen cream 6 weeks before undergoing hysterectomy resulted in increased thickness of both the vaginal epithelium and the muscularis, results of a randomized trial showed.

"Surgical repair remains the mainstay treatment for symptomatic prolapse," Dr. David D. Rahn said at the annual meeting of the American Urogynecologic Society. "Despite advances in surgical techniques, reoperation for recurrent prolapse is common. Clearly, there are significant trade-offs to adding graft material to surgical repairs. Given that our population is aging, there will be more women requiring surgical management of prolapse. Therefore, there’s a need to identify adjuncts to native tissue prolapse repairs that may minimize recurrent disease or lessen the likelihood of graft-associated complications."

Both basic science and clinical investigations indicate that estrogen plays an important role in the function of supportive connective tissues at the pelvic floor, said Dr. Rahn of the department of obstetrics and gynecology at the University of Texas Southwestern Medical Center, Dallas. However, clinical research regarding the effects of systemic hormone therapy on prevention or treatment of prolapse "has led to contradictory findings, with some studies suggesting a protective effect while others demonstrating either no difference or perhaps higher rates of prolapse in women using hormone therapy."

To determine the effects of vaginal estrogen on collagen synthesis in connective tissues of the vaginal muscularis and mucosa in postmenopausal women, Dr. Rahn and his associates enrolled 30 women who were 1-10 year postmenopausal with at least stage 2 anterior or apical prolapse planning total hysterectomy as part of a surgical repair. They excluded women with a body mass index of greater than 35 kg/m², current users of tobacco or steroids, and those with a vaginal infection. Of the 30 patients, 15 were randomized to receive Premarin, a conjugated estrogens cream, while the remaining 15 received placebo cream. "They were instructed to apply 1 g using the plastic applicator nightly for 2 weeks and then twice weekly for 4 more weeks until surgery," Dr. Rahn said. "A computer-generated randomization table was used to allocate patients to one of the treatment groups. Only the pharmacist remained unblinded to treatment allocation."

The researchers performed histomorphology, quantitative polymerase chain reaction, hydroxyproline assays, and immunoblot analyses to evaluate vaginal epithelium and muscularis from standardized full thickness anterior vaginal cuff biopsies obtained at the time of surgery. Zymography was used to assess matrix metalloproteinase (MMP) activity.

Full biopsy data were available from 12 patients in each arm. Dr. Rahn reported that their mean age was 57 years, slightly more than half (57%) were Hispanic, and their mean BMI was 30.5 kg/m². On histological assessment, the epithelial and the muscularis layer were thicker among samples from women treated with estrogen. Specifically, mean epithelial thickness was increased 1.8-fold in the estrogen group, while the muscularis thickness was increased 2.7-fold.

To determine if these estrogen-induced increases in muscularis thickness were associated with increased collagen synthesis, relative messenger RNA levels of collagen type I, alpha-1, type I, alpha-2, and collagen type III mRNA were quantified in the muscularis samples from both groups. Collagen I, alpha-1 was increased sixfold in the vaginal muscularis in the estrogen group, while collagen type I, alpha-2 and collagen type III mRNA were increased 1.8- and 2.5-fold, respectively.

Immunoblot analysis was completed in four patients in each treatment group who had sufficient tissue for protein analysis. Collagen type 1a monomers, dimers, and trimers were all increased 10-fold in the muscularis from samples of women treated with estrogen. In contrast, differences in collagen 3 protein were not significant. Further, with respect to matrix degradation, in patients adherent with local estrogen, human macrophage elastase mRNA was suppressed in the vaginal mucosa from estrogen-treated participants, and MMP-9 activity was decreased 6-fold in the mucosa and 4-fold in the muscularis. There was no change in expression of several protease inhibitors.

"Our findings from this trial suggest that 6 weeks of preoperative vaginal estrogen in postmenopausal women with prolapse may improve the substrate for suture placement at the time of repair while mitigating surgical induction of several degradative enzymes," Dr. Rahn concluded.

The study was funded by an Astellas Research Award/AUGS Foundation grant. Dr. Rahn said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

LAS VEGAS – Application of vaginal estrogen cream 6 weeks before undergoing hysterectomy resulted in increased thickness of both the vaginal epithelium and the muscularis, results of a randomized trial showed.

"Surgical repair remains the mainstay treatment for symptomatic prolapse," Dr. David D. Rahn said at the annual meeting of the American Urogynecologic Society. "Despite advances in surgical techniques, reoperation for recurrent prolapse is common. Clearly, there are significant trade-offs to adding graft material to surgical repairs. Given that our population is aging, there will be more women requiring surgical management of prolapse. Therefore, there’s a need to identify adjuncts to native tissue prolapse repairs that may minimize recurrent disease or lessen the likelihood of graft-associated complications."

Both basic science and clinical investigations indicate that estrogen plays an important role in the function of supportive connective tissues at the pelvic floor, said Dr. Rahn of the department of obstetrics and gynecology at the University of Texas Southwestern Medical Center, Dallas. However, clinical research regarding the effects of systemic hormone therapy on prevention or treatment of prolapse "has led to contradictory findings, with some studies suggesting a protective effect while others demonstrating either no difference or perhaps higher rates of prolapse in women using hormone therapy."

To determine the effects of vaginal estrogen on collagen synthesis in connective tissues of the vaginal muscularis and mucosa in postmenopausal women, Dr. Rahn and his associates enrolled 30 women who were 1-10 year postmenopausal with at least stage 2 anterior or apical prolapse planning total hysterectomy as part of a surgical repair. They excluded women with a body mass index of greater than 35 kg/m², current users of tobacco or steroids, and those with a vaginal infection. Of the 30 patients, 15 were randomized to receive Premarin, a conjugated estrogens cream, while the remaining 15 received placebo cream. "They were instructed to apply 1 g using the plastic applicator nightly for 2 weeks and then twice weekly for 4 more weeks until surgery," Dr. Rahn said. "A computer-generated randomization table was used to allocate patients to one of the treatment groups. Only the pharmacist remained unblinded to treatment allocation."

The researchers performed histomorphology, quantitative polymerase chain reaction, hydroxyproline assays, and immunoblot analyses to evaluate vaginal epithelium and muscularis from standardized full thickness anterior vaginal cuff biopsies obtained at the time of surgery. Zymography was used to assess matrix metalloproteinase (MMP) activity.

Full biopsy data were available from 12 patients in each arm. Dr. Rahn reported that their mean age was 57 years, slightly more than half (57%) were Hispanic, and their mean BMI was 30.5 kg/m². On histological assessment, the epithelial and the muscularis layer were thicker among samples from women treated with estrogen. Specifically, mean epithelial thickness was increased 1.8-fold in the estrogen group, while the muscularis thickness was increased 2.7-fold.

To determine if these estrogen-induced increases in muscularis thickness were associated with increased collagen synthesis, relative messenger RNA levels of collagen type I, alpha-1, type I, alpha-2, and collagen type III mRNA were quantified in the muscularis samples from both groups. Collagen I, alpha-1 was increased sixfold in the vaginal muscularis in the estrogen group, while collagen type I, alpha-2 and collagen type III mRNA were increased 1.8- and 2.5-fold, respectively.

Immunoblot analysis was completed in four patients in each treatment group who had sufficient tissue for protein analysis. Collagen type 1a monomers, dimers, and trimers were all increased 10-fold in the muscularis from samples of women treated with estrogen. In contrast, differences in collagen 3 protein were not significant. Further, with respect to matrix degradation, in patients adherent with local estrogen, human macrophage elastase mRNA was suppressed in the vaginal mucosa from estrogen-treated participants, and MMP-9 activity was decreased 6-fold in the mucosa and 4-fold in the muscularis. There was no change in expression of several protease inhibitors.

"Our findings from this trial suggest that 6 weeks of preoperative vaginal estrogen in postmenopausal women with prolapse may improve the substrate for suture placement at the time of repair while mitigating surgical induction of several degradative enzymes," Dr. Rahn concluded.

The study was funded by an Astellas Research Award/AUGS Foundation grant. Dr. Rahn said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com