Pediatrics. 2010;125:1094-1100.
Clinical Context
IPV is defined as a pattern of coercive behaviors that might include repeated battering and injury, psychological abuse, sexual abuse, progressive social isolation, deprivation, and intimidation perpetuated by someone with a prior or current intimate relationship with the victim, according to the Centers for Disease Control and Prevention 1999 statement.
According to the Bureau of Justice Statistics, 2004 data for the United States showed that 1544 deaths were attributed to IPV, of whom 75% were women. According to the Family Violence Prevention Fund, IPV occurs in heterosexual, lesbian, gay, bisexual, and transgender relationships.
This report from the AAP addresses the effects of IPV exposure on children and recommendations for assessment and response to IPV.
Study Highlights
Child victims of IPV
The most vulnerable groups are girls and women aged 16 to 24 years: 1 in 5 high school students and almost half of college students report dating violence.
IPV occurs in 3% to 19% of pregnant women and is linked with effects on the offspring: preterm labor, low birth weight, intracranial injury, neonatal death, and increased healthcare use and costs.
Co-occurrence of child abuse and IPV has been reported in 30% to 60% of families.
IPV is the leading precursor of child abuse.
Younger children can be collateral victims of IPV if they are being held in a caregiver's arms during battering. Older children who intervene during the incident can also be collateral victims.
Childhood exposure to IPV
Adults with childhood exposure to IPV vs no IPV exposure are 6 times more likely to be emotionally abused, 4.8 times more likely to be physically abused, and 2.6 times more likely to be sexually abused.
IPV exposure and other adverse childhood experiences are linked with smoking, obesity, physical inactivity, depression, and suicide attempts.
Children of abused caregivers have an increased risk for adverse behavioral effects: anxiety, depression, withdrawal, somatic symptoms, attention issues, aggressive behavior, rule-breaking behavior, social functioning problems, difficulty with peer relationships, cruelty to others, poor academic performance, and symptoms of posttraumatic stress disorder.
Adolescents might have the same violence pattern in their relationships with others, and some children might abuse others.
Requirements for reporting IPV to child protective services differ by state based on the child's age, relationship of the child to the perpetrator, and proximity of the child to the violent incident.
Having the caregiver also file a report might be helpful.
Assessment for IPV
Early and repeated questions to identify IPV as part of anticipatory guidance and awareness of risk factors for IPV are recommended.
Universal screening vs a case-finding approach results in greater identification of abuse, but insufficient evidence exists to show difference in morbidity or mortality rates of the victim.
Usually there are no indications of abuse.
Most victims will obtain care for their children instead of for themselves.
Possible indications of abuse include depression, anxiety, not keeping medical appointments, not answering questions about discipline, and frequent visits for complaints not consistent with the medical evaluation.
Self-administered assessments vs verbal assessments are preferred by female victims and might overcome barriers to IPV detection.
Questioning for suspected IPV should be conducted in a sympathetic and sensitive manner in a private setting without the presence of any children, family, friends, and suspected abuser.
Documentation is appropriate with the awareness that the abuser could have access to the records.
A generic statement that IPV assessment occurred and resources offered per protocol is suggested.
Referrals
A community response can be coordinated by pediatricians, obstetricians, prenatal clinic and hospital nurses, social workers, public health administrators, and early childhood education programs.
Resources include the Family Violence Prevention Fund, the American Medical Association, state medical associations, and the AAP.
Knowledge of state laws for reporting partner violence and children exposed to IPV is essential.
Risk for injury or death might increase when the caregiver discloses abuse and tries to leave the abuser.
Firearms should be removed from the home.
Pediatricians should be aware of "stages of change," substance abuse issues, and the role of ethnic and cultural attitudes on disclosure.
Counseling for children should focus on understanding and avoiding violence.
Clinical Implications
IPV of pregnant women or in the household increases the risk for child abuse and short-term and long-term medical, behavioral, and mental health problems in the children.
Recommendations to assess IPV exposure in children include early and repeated questioning as part of anticipatory guidance, self-administered survey with appropriate verbal follow-up, sympathetic and sensitive manner, private setting, and appropriate documentation.
Monday, May 17, 2010
Friday, May 7, 2010
High-Dose Simvastatin Associated With Increased Risk for Myopathy, FDA Warns
From Medscape Medical News > Medscape Alerts
Emma Hitt, PhD
March 19, 2010 — Simvastatin (Zocor, Merck/Schering-Plough Pharmaceuticals), used at the highest approved dose of 80 mg, is associated with an increased risk for myopathy, including rhabdomyolysis, according to the US Food and Drug Administration (FDA).
The alert sent today from MedWatch, the FDA's safety information and adverse event reporting program, was based on a review of data from the large clinical Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial. Other sources, including data from clinical trials, observational studies, and adverse event reports, as well as data on prescription use of simvastatin, are under review.
The SEARCH trial evaluated the number of major cardiovascular events (heart attack, revascularization, and cardiovascular death) in 6031 patients with a history of myocardial infarction taking 80 mg of simvastatin and compared that number with that from 6033 patients taking 20 mg of simvastatin. The study included 6.7 years of follow-up.
According to preliminary results, more patients in the simvastatin 80-mg group developed myopathy compared with patients in the simvastatin 20-mg group (52 cases [0.9%] vs 1 case [0.02%]). In addition, 11 patients in the simvastatin 80-mg group (0.02%) developed rhabdomyolysis compared with no patients in the simvastatin 20-mg group.
"Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available," noted Eric Colman, MD, deputy director of the FDA's Division of Metabolism and Endocrinology Products, in a news release.
According to the FDA, healthcare professionals should consider the following when prescribing simvastatin:
Rhabdomyolysis is a rare class effect associated with statins
The increased risk for muscle injury with the 80-mg dose of simvastatin is compared with the use of lower doses of simvastatin and possibly other statin drugs
Whether simvastatin is clinically appropriate
Discuss with patients the benefits and risks of simvastatin
Potential drug–drug interactions can occur with simvastatin
Last month, simvastatin was one of 27 drugs or drug categories that was included on an FDA watch list, based on potential signs of serious risks or new safety information identified in the agency's Adverse Event Reporting System last year.
Risk for myopathy may be linked to genetic heterogeneity in statin users. A study published in the October 20, 2009, issue of the Journal of American College of Cardiology found that carriers of the reduced-function single nucleotide polymorphism of the SLCO1B1 gene were at increased risk of developing mild statin-induced adverse effects, including myopathy and myalgia. The risk for adverse events was greatest among those treated with simvastatin, but minimal in those receiving pravastatin.
More information about simvastatin and myopathy risk is available on the FDA's Web site.
Previous FDA safety communications on the increased risk for muscle injury with simvastatin in patients who concurrently take other medications is also available on the FDA's Web site.
Simvastatin is sold as a single agent and also in combination with ezetimibe (Vytorin, Merck/Schering-Plough Pharmaceuticals) and in combination with niacin (Simcor, Abbott Laboratories).
Rhabdomyolysis is the most serious form of myopathy and is associated with severe renal toxicity and failure, and occasional fatalities.
Adverse events related to simvastatin should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
Emma Hitt, PhD
March 19, 2010 — Simvastatin (Zocor, Merck/Schering-Plough Pharmaceuticals), used at the highest approved dose of 80 mg, is associated with an increased risk for myopathy, including rhabdomyolysis, according to the US Food and Drug Administration (FDA).
The alert sent today from MedWatch, the FDA's safety information and adverse event reporting program, was based on a review of data from the large clinical Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial. Other sources, including data from clinical trials, observational studies, and adverse event reports, as well as data on prescription use of simvastatin, are under review.
The SEARCH trial evaluated the number of major cardiovascular events (heart attack, revascularization, and cardiovascular death) in 6031 patients with a history of myocardial infarction taking 80 mg of simvastatin and compared that number with that from 6033 patients taking 20 mg of simvastatin. The study included 6.7 years of follow-up.
According to preliminary results, more patients in the simvastatin 80-mg group developed myopathy compared with patients in the simvastatin 20-mg group (52 cases [0.9%] vs 1 case [0.02%]). In addition, 11 patients in the simvastatin 80-mg group (0.02%) developed rhabdomyolysis compared with no patients in the simvastatin 20-mg group.
"Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available," noted Eric Colman, MD, deputy director of the FDA's Division of Metabolism and Endocrinology Products, in a news release.
According to the FDA, healthcare professionals should consider the following when prescribing simvastatin:
Rhabdomyolysis is a rare class effect associated with statins
The increased risk for muscle injury with the 80-mg dose of simvastatin is compared with the use of lower doses of simvastatin and possibly other statin drugs
Whether simvastatin is clinically appropriate
Discuss with patients the benefits and risks of simvastatin
Potential drug–drug interactions can occur with simvastatin
Last month, simvastatin was one of 27 drugs or drug categories that was included on an FDA watch list, based on potential signs of serious risks or new safety information identified in the agency's Adverse Event Reporting System last year.
Risk for myopathy may be linked to genetic heterogeneity in statin users. A study published in the October 20, 2009, issue of the Journal of American College of Cardiology found that carriers of the reduced-function single nucleotide polymorphism of the SLCO1B1 gene were at increased risk of developing mild statin-induced adverse effects, including myopathy and myalgia. The risk for adverse events was greatest among those treated with simvastatin, but minimal in those receiving pravastatin.
More information about simvastatin and myopathy risk is available on the FDA's Web site.
Previous FDA safety communications on the increased risk for muscle injury with simvastatin in patients who concurrently take other medications is also available on the FDA's Web site.
Simvastatin is sold as a single agent and also in combination with ezetimibe (Vytorin, Merck/Schering-Plough Pharmaceuticals) and in combination with niacin (Simcor, Abbott Laboratories).
Rhabdomyolysis is the most serious form of myopathy and is associated with severe renal toxicity and failure, and occasional fatalities.
Adverse events related to simvastatin should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
Hepatocellular Carcinoma Continues to Increase in US
From Medscape Medical News
Zosia Chustecka
May 7, 2010 — The incidence of hepatocellular carcinoma increased significantly in the United States between 2001 and 2006, according to the latest population-based estimates reported by the Center for Diseases Control and Prevention (CDC).
The increase is reported in the May 7 issue of Morbidity and Mortality Weekly Report (MMWR). The report coincides with Hepatitis Awareness Month in the United States, which is in its fifteenth year.
The MMWR report notes that the average annual incidence rate of hepatocellular carcinoma increased significantly, from 2.7 per 100,000 people in 2001 to 3.2 per 100,000 people in 2006, with an average annual percentage change in incidence rate of 3.5%.
The findings indicate continued increases in hepatocellular carcinoma incidence, write the authors, adding that improvements in viral hepatitis services are needed to reverse this trend.
This call for improved action on hepatitis, a leading cause of hepatocellular cancer, echoes the detailed recommendations for action laid out recently in a report from the Institute of Medicine (IOM), as reported by Medscape Oncology.
That IOM report recommended a national strategy for the prevention and control of hepatitis B and C virus infection, pointing out that it disproportionately affects minorities.
The latest figures from the CDC show persistent racial/ethnic disparities, the authors add. The incidence of hepatocellular carcinoma was highest among Asians/Pacific Islanders (7.8 per 100,000 people), followed by blacks (4.2), American Indians/Alaska Natives (3.2), and whites (2.6). The incidence among Hispanics (5.7 per 100,000 people) was nearly double that for non-Hispanics (2.8).
Most Cases Preventable
Hepatocellular carcinoma is the ninth leading cause of cancer death in the United States (and the third leading cause worldwide), the CDC authors note. But most cases could be prevented, they point out.
Chronic hepatitis B and C virus infections account for 78% of all hepatocellular cancer in the United States, and prevention of virus transmission and progression of chronic viral disease has been shown to decrease the incidence of this cancer, they point out.
Improvements in viral hepatitis services and public health surveillance are needed, the authors suggest. These should include full implementation of vaccine-based strategies to eliminate hepatitis B, and screening and care referrals for individuals chronically infected with hepatitis B or C. Most Americans who already have a chronic viral hepatitis are unaware of their infection, the authors point out.
The subject of hepatitis leading to liver cancer — and how it can be prevented — was discussed in some detail when the IOM report was released in January 2010, when detailed plans for action — many involving the CDC — were outlined.
At that time, Andrew Muir, MD, clinical director of hepatology at Duke University School of Medicine in Durham, North Carolina, said that the IOM report highlights "many important issues we see in our clinics."
"Too many patients are unaware they have viral hepatitis, and this makes it difficult to control the spread of these infections and provide appropriate treatment to those infected. Too many patients present to our clinics in the late stages of cirrhosis or with advanced liver cancer. If we could identify these patients sooner, we [would be able to use the effective treatment strategies we have] to help them avoid these devastating complications," Dr. Muir said.
"We need coordinated surveillance and educational programs to aid us in these efforts," he concluded.
MMWR. 2010;59(17);517-520.
Zosia Chustecka
May 7, 2010 — The incidence of hepatocellular carcinoma increased significantly in the United States between 2001 and 2006, according to the latest population-based estimates reported by the Center for Diseases Control and Prevention (CDC).
The increase is reported in the May 7 issue of Morbidity and Mortality Weekly Report (MMWR). The report coincides with Hepatitis Awareness Month in the United States, which is in its fifteenth year.
The MMWR report notes that the average annual incidence rate of hepatocellular carcinoma increased significantly, from 2.7 per 100,000 people in 2001 to 3.2 per 100,000 people in 2006, with an average annual percentage change in incidence rate of 3.5%.
The findings indicate continued increases in hepatocellular carcinoma incidence, write the authors, adding that improvements in viral hepatitis services are needed to reverse this trend.
This call for improved action on hepatitis, a leading cause of hepatocellular cancer, echoes the detailed recommendations for action laid out recently in a report from the Institute of Medicine (IOM), as reported by Medscape Oncology.
That IOM report recommended a national strategy for the prevention and control of hepatitis B and C virus infection, pointing out that it disproportionately affects minorities.
The latest figures from the CDC show persistent racial/ethnic disparities, the authors add. The incidence of hepatocellular carcinoma was highest among Asians/Pacific Islanders (7.8 per 100,000 people), followed by blacks (4.2), American Indians/Alaska Natives (3.2), and whites (2.6). The incidence among Hispanics (5.7 per 100,000 people) was nearly double that for non-Hispanics (2.8).
Most Cases Preventable
Hepatocellular carcinoma is the ninth leading cause of cancer death in the United States (and the third leading cause worldwide), the CDC authors note. But most cases could be prevented, they point out.
Chronic hepatitis B and C virus infections account for 78% of all hepatocellular cancer in the United States, and prevention of virus transmission and progression of chronic viral disease has been shown to decrease the incidence of this cancer, they point out.
Improvements in viral hepatitis services and public health surveillance are needed, the authors suggest. These should include full implementation of vaccine-based strategies to eliminate hepatitis B, and screening and care referrals for individuals chronically infected with hepatitis B or C. Most Americans who already have a chronic viral hepatitis are unaware of their infection, the authors point out.
The subject of hepatitis leading to liver cancer — and how it can be prevented — was discussed in some detail when the IOM report was released in January 2010, when detailed plans for action — many involving the CDC — were outlined.
At that time, Andrew Muir, MD, clinical director of hepatology at Duke University School of Medicine in Durham, North Carolina, said that the IOM report highlights "many important issues we see in our clinics."
"Too many patients are unaware they have viral hepatitis, and this makes it difficult to control the spread of these infections and provide appropriate treatment to those infected. Too many patients present to our clinics in the late stages of cirrhosis or with advanced liver cancer. If we could identify these patients sooner, we [would be able to use the effective treatment strategies we have] to help them avoid these devastating complications," Dr. Muir said.
"We need coordinated surveillance and educational programs to aid us in these efforts," he concluded.
MMWR. 2010;59(17);517-520.
Thursday, May 6, 2010
Screening Mammograms May Have Low Accuracy in Younger Women
From Medscape Medical News
Laurie Barclay, MD
May 5, 2010 — Screening mammograms in younger women have low accuracy and detect few cancers, according to the results of a study published online May 3 in the Journal of the National Cancer Institute.
"Few data have been published on mammography performance in women who are younger than 40 years," write Bonnie C. Yankaskas, PhD, from the University of North Carolina at Chapel Hill, and colleagues. "We pooled data from six mammography registries across the United States from the Breast Cancer Surveillance Consortium."
The study cohort consisted of 117,738 women who had their first screening or diagnostic mammogram during 1995 to 2005, when they were 18 to 39 years of age. Follow-up for 1 year allowed the investigators to measure the accuracy of mammographic evaluation, recall rate for screening examinations, and sensitivity, specificity, positive predictive value, and cancer detection rate for all mammograms.
No cancers were detected in 637 screening mammograms performed in women 18 to 24 years of age. The largest number of screening mammograms in this study was in women aged 35 to 39 years (n = 73,335). In this group, the recall rate was 12.7% (95% confidence interval [CI], 12.4% - 12.9%), sensitivity was 76.1% (95% CI, 69.2% - 82.6%), specificity was 87.5% (95% CI, 87.2% - 87.7%), positive predictive value was 1.3% (95% CI, 1.1% - 1.5%), and cancer detection rate was 1.6 cancers per 1000 mammograms (95% CI, 1.3 - 1.9 cancers per 1000 mammograms).
Of the 86,871 women screened, 67,468 (77.7%) reported no family history of breast cancer. Across all age groups, the age-adjusted rates for diagnostic mammograms were sensitivity of 85.7% (95% CI, 82.7% - 88.7%), specificity of 88.8% (95% CI, 88.4% - 89.1%), positive predictive value of 14.6% (95% CI, 13.3% - 15.8%), and cancer detection rate of 14.3 cancers per 1000 mammograms (95% CI, 13.0 - 15.7 cancers per 1000 mammograms). Except for specificity, diagnostic measures of mammography performance were better in women who had a breast lump.
"Younger women have very low breast cancer rates but after mammography experience high recall rates, high rates of additional imaging, and low cancer detection rates," the study authors write. "We found no cancers in women younger than 25 years and poor performance for the large group of women aged 35-39 years. In a theoretical population of 10 000 women aged 35-39 years, 1266 women who are screened will receive further workup, with 16 cancers detected and 1250 women receiving a false-positive result."
Limitations of this study include a substantial amount of missing data and the inability to collect a complete family pedigree or BRCA1 or BRCA2 status, which would help identify women at very high risk.
The journal editors note that screening young women is not without potential harms, which may include additional radiation exposure, anxiety because of false-positive findings, and costs of additional imaging.
In an accompanying editorial, Ned Calonge, MD, MPH, from the Colorado Department of Public Health and Environment, Denver, calls this a "landmark descriptive study." He also points out that even women who had a family history of breast cancer had the same detection and false-positive rates as women without known family history, casting doubt on the recommendation of some health groups for early screening of women with a positive family history.
"[W]e must continue to strive for better tests and better treatments," Dr. Calonge writes. "We need clinical trial data on the screening utility of any modality or strategy for high-risk women in this age group and better data on the use of early or other enhanced screening for women with high-risk genetic mutations. Furthermore, we should not be satisfied with better detection rates alone: We need evidence that early detection of these cancers translates to improvements in important health outcomes. "
The National Cancer Institute–funded Breast Cancer Surveillance Consortium supported this study. Financial relationships for the authors were not reported in the study.
J Natl Cancer Inst. Published online May 3, 2010.
Laurie Barclay, MD
May 5, 2010 — Screening mammograms in younger women have low accuracy and detect few cancers, according to the results of a study published online May 3 in the Journal of the National Cancer Institute.
"Few data have been published on mammography performance in women who are younger than 40 years," write Bonnie C. Yankaskas, PhD, from the University of North Carolina at Chapel Hill, and colleagues. "We pooled data from six mammography registries across the United States from the Breast Cancer Surveillance Consortium."
The study cohort consisted of 117,738 women who had their first screening or diagnostic mammogram during 1995 to 2005, when they were 18 to 39 years of age. Follow-up for 1 year allowed the investigators to measure the accuracy of mammographic evaluation, recall rate for screening examinations, and sensitivity, specificity, positive predictive value, and cancer detection rate for all mammograms.
No cancers were detected in 637 screening mammograms performed in women 18 to 24 years of age. The largest number of screening mammograms in this study was in women aged 35 to 39 years (n = 73,335). In this group, the recall rate was 12.7% (95% confidence interval [CI], 12.4% - 12.9%), sensitivity was 76.1% (95% CI, 69.2% - 82.6%), specificity was 87.5% (95% CI, 87.2% - 87.7%), positive predictive value was 1.3% (95% CI, 1.1% - 1.5%), and cancer detection rate was 1.6 cancers per 1000 mammograms (95% CI, 1.3 - 1.9 cancers per 1000 mammograms).
Of the 86,871 women screened, 67,468 (77.7%) reported no family history of breast cancer. Across all age groups, the age-adjusted rates for diagnostic mammograms were sensitivity of 85.7% (95% CI, 82.7% - 88.7%), specificity of 88.8% (95% CI, 88.4% - 89.1%), positive predictive value of 14.6% (95% CI, 13.3% - 15.8%), and cancer detection rate of 14.3 cancers per 1000 mammograms (95% CI, 13.0 - 15.7 cancers per 1000 mammograms). Except for specificity, diagnostic measures of mammography performance were better in women who had a breast lump.
"Younger women have very low breast cancer rates but after mammography experience high recall rates, high rates of additional imaging, and low cancer detection rates," the study authors write. "We found no cancers in women younger than 25 years and poor performance for the large group of women aged 35-39 years. In a theoretical population of 10 000 women aged 35-39 years, 1266 women who are screened will receive further workup, with 16 cancers detected and 1250 women receiving a false-positive result."
Limitations of this study include a substantial amount of missing data and the inability to collect a complete family pedigree or BRCA1 or BRCA2 status, which would help identify women at very high risk.
The journal editors note that screening young women is not without potential harms, which may include additional radiation exposure, anxiety because of false-positive findings, and costs of additional imaging.
In an accompanying editorial, Ned Calonge, MD, MPH, from the Colorado Department of Public Health and Environment, Denver, calls this a "landmark descriptive study." He also points out that even women who had a family history of breast cancer had the same detection and false-positive rates as women without known family history, casting doubt on the recommendation of some health groups for early screening of women with a positive family history.
"[W]e must continue to strive for better tests and better treatments," Dr. Calonge writes. "We need clinical trial data on the screening utility of any modality or strategy for high-risk women in this age group and better data on the use of early or other enhanced screening for women with high-risk genetic mutations. Furthermore, we should not be satisfied with better detection rates alone: We need evidence that early detection of these cancers translates to improvements in important health outcomes. "
The National Cancer Institute–funded Breast Cancer Surveillance Consortium supported this study. Financial relationships for the authors were not reported in the study.
J Natl Cancer Inst. Published online May 3, 2010.
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