User login
Rash on forearm
The FP did not recognize the rash, so she decided to do a Google search. She typed the following terms into the search box: linear hypopigmented papules on the arm of a child. Almost every result described lichen striatus.
The photographs were very similar, and the description was a great fit for the patient’s condition. Clearly, this was not poison ivy and was unrelated to the camping trip. The physician learned that lichen striatus is a benign idiopathic condition that often affects children on a single extremity. The flat-topped papules tend to run parallel to the long axis of the extremity following Blaschko lines (lines related to embryogenesis). In darker-skinned patients, the papules are often hypopigmented. The papules are usually asymptomatic and resolve on their own, over time.
The mother was reassured and happy to hear that this would go away without any treatment. The physician was delighted to have been able to make a diagnosis by using her ability to describe the rash and the “intelligence” of the search engine.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Epidermal nevus and nevus sebaceous. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:958-962.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.
The FP did not recognize the rash, so she decided to do a Google search. She typed the following terms into the search box: linear hypopigmented papules on the arm of a child. Almost every result described lichen striatus.
The photographs were very similar, and the description was a great fit for the patient’s condition. Clearly, this was not poison ivy and was unrelated to the camping trip. The physician learned that lichen striatus is a benign idiopathic condition that often affects children on a single extremity. The flat-topped papules tend to run parallel to the long axis of the extremity following Blaschko lines (lines related to embryogenesis). In darker-skinned patients, the papules are often hypopigmented. The papules are usually asymptomatic and resolve on their own, over time.
The mother was reassured and happy to hear that this would go away without any treatment. The physician was delighted to have been able to make a diagnosis by using her ability to describe the rash and the “intelligence” of the search engine.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Epidermal nevus and nevus sebaceous. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:958-962.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.
The FP did not recognize the rash, so she decided to do a Google search. She typed the following terms into the search box: linear hypopigmented papules on the arm of a child. Almost every result described lichen striatus.
The photographs were very similar, and the description was a great fit for the patient’s condition. Clearly, this was not poison ivy and was unrelated to the camping trip. The physician learned that lichen striatus is a benign idiopathic condition that often affects children on a single extremity. The flat-topped papules tend to run parallel to the long axis of the extremity following Blaschko lines (lines related to embryogenesis). In darker-skinned patients, the papules are often hypopigmented. The papules are usually asymptomatic and resolve on their own, over time.
The mother was reassured and happy to hear that this would go away without any treatment. The physician was delighted to have been able to make a diagnosis by using her ability to describe the rash and the “intelligence” of the search engine.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Epidermal nevus and nevus sebaceous. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:958-962.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.
New hypertension guidelines would add 15.6 million new diagnoses
A new analysis estimates that adopting the 2017 ACC/AHA hypertension guidelines would add 15.6 million Americans to the ranks of the hypertensives, and half of those would be candidates for treatment.
Similar increases would occur in other countries, according to study authors, who analyzed two large datasets from the United States and China.
That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, meaning more than half of people aged 45-75 years in both countries would be classified as having hypertension, according to the researchers, led by Harlan M. Krumholz, MD, of the Center for Outcomes Research and Evaluation at Yale–New Haven (Conn.) Hospital and the section of cardiovascular medicine at Yale
An additional 7.5 million Americans would be recommended for treatment under the new lower treatment thresholds, with a correspondingly large increase in the Chinese population, according to results published in the BMJ.
The guideline changes are “not firmly rooted in evidence” and could have health policy implications that include strain on public health programs, Dr. Krumholz and his colleagues said in their report on the study.
“The change occurs at a time when both countries have substantial numbers of people who are not aware of having hypertension, and who have hypertension that is not controlled, even according to the previous standards,” they wrote.
The analysis by Dr. Krumholz and his colleagues was based on the two most recent cycles of the U.S. National Health and Nutrition Examination Survey (NHANES), representing 2013-2014 and 2015-2016 periods, as well as the China Health and Retirement Longitudinal Study (CHARLS) in 2011-2012.
Under the new ACC/AHA guidelines, they found, 70.1 million Americans aged 45-65 years would be classified as hypertensive, representing 63% of that age group. That’s a 27% relative increase over the 55.3 million individuals, or 49.7%, with hypertension as defined in the JNC-8 guidelines.
In addition, 15.6 million persons would be classified as eligible for treatment but not receiving it, up from 8.1 million under the JNC-8 guidance.
Previous estimates projected a far greater jump in new hypertension classifications, including one that used data from the National Health and Nutrition Examination Survey, antihypertensive clinical trials, and population-based cohort studies. That study estimated that 31 million people would newly carry the label (JAMA Cardiol. 2018 May 23; doi: 10.1001/jamacardio.2018.1240.)
In the current analysis, in China, 267 million aged 45-65 years (55% of that age group) would be classified with hypertension under the ACC/AHA guidelines, a relative increase of 45% over the JNC-8 guidelines, while the number of candidates for treatment would be 129 million, up from 74.5 million under the earlier guidelines.
Dr. Krumholz noted that the ACC/AHA guideline changes were prompted by results from the SPRINT trial. However, the improvements in outcomes seen in SPRINT, which included patients at high risk for cardiovascular events but without diabetes, have not been observed in individuals at low or intermediate risk, or in those with diabetes, they said.
“Expanding the pool of patients who merit treatment to include those at low risk could potentially render public health programs less efficient and viable,” they wrote in a discussion of health policy implications.
The new guidelines also put millions at risk of the “psychological morbidity” that comes with the label of a chronic disease, and at risk for more adverse events caused by inappropriate use of drug therapy, they added.
Dr. Krumholz reported research agreements from Medtronic and from Johnson and Johnson (Janssen) through Yale University, and a grant from the Food and Drug Administration and Medtronic. He reported other disclosures related to UnitedHealth, the IBM Watson Health Life Sciences Board, Element Science, Aetna, and Hugo, a personal health information platform he founded. First author Rohan Khera, MD, reported support from the National Institutes of Health.
SOURCE: Khera R et al. BMJ. 2018 Jul 11;362:k2357
This article was updated 7/19/18.
This study addressing hypertension guideline changes is unique because it was initially published on a public preprint server.
Preprints are common in some scientific areas, but uncommon in major medical journals. They allow investigators to share research, quickly and openly, for critique and feedback before standard peer review and publication.
In the case of this study, researchers analyzed the public health implications of the anticipated changes to the 2017 ACC/AHA hypertension guidelines in two nationally representative data sets from the United States and China.
The authors quickly finalized their manuscript right after the revised hypertension guidelines were released. They chose the preprint approach because they realized their research would be immediately relevant to the discussion that followed, first author Rohan Khera, MD, recounted on BMJ Blogs.
“The traditional approach of submitting to a medical journal would mean being out of the public eye for several months,” Dr. Khera said in his post. “The preprint platform offered us an excellent opportunity of ensuring early dissemination of our research study in its entirety, while we sought its evaluation by peer reviewers and the refinement by a medical journal.”
The manuscript was submitted via a Web-based system and was publicly available 2 hours later on the same day the guidelines were published. The researchers received comments and suggestions on the preprint, some of which were incorporated into the final manuscript they submitted for peer review.
Then the manuscript went through the usual iterative peer review process; however, the preprint was still available online to guide other investigators and limit duplication of effort, Dr. Khera said in his blog post.
That contrasts with another recent experience in which Dr. Khera and his colleagues performed work that “failed to inform” ongoing policy discussions, and other research efforts, while they waited for eventual publication.
“We hope that more journals will accept the benefits of science that is publicly available while journal editors and peer reviewers carry out their critical role of improving both the quality and the impact of these scientific contributions,” Dr. Khera wrote.
Rohan Khera, MD, a cardiology fellow at the University of Texas (Dallas) Southwestern Medical Center in, wrote about his experience with preprints for BMJ Blogs . Dr. Khera had no conflicts of interest to disclose.
This study addressing hypertension guideline changes is unique because it was initially published on a public preprint server.
Preprints are common in some scientific areas, but uncommon in major medical journals. They allow investigators to share research, quickly and openly, for critique and feedback before standard peer review and publication.
In the case of this study, researchers analyzed the public health implications of the anticipated changes to the 2017 ACC/AHA hypertension guidelines in two nationally representative data sets from the United States and China.
The authors quickly finalized their manuscript right after the revised hypertension guidelines were released. They chose the preprint approach because they realized their research would be immediately relevant to the discussion that followed, first author Rohan Khera, MD, recounted on BMJ Blogs.
“The traditional approach of submitting to a medical journal would mean being out of the public eye for several months,” Dr. Khera said in his post. “The preprint platform offered us an excellent opportunity of ensuring early dissemination of our research study in its entirety, while we sought its evaluation by peer reviewers and the refinement by a medical journal.”
The manuscript was submitted via a Web-based system and was publicly available 2 hours later on the same day the guidelines were published. The researchers received comments and suggestions on the preprint, some of which were incorporated into the final manuscript they submitted for peer review.
Then the manuscript went through the usual iterative peer review process; however, the preprint was still available online to guide other investigators and limit duplication of effort, Dr. Khera said in his blog post.
That contrasts with another recent experience in which Dr. Khera and his colleagues performed work that “failed to inform” ongoing policy discussions, and other research efforts, while they waited for eventual publication.
“We hope that more journals will accept the benefits of science that is publicly available while journal editors and peer reviewers carry out their critical role of improving both the quality and the impact of these scientific contributions,” Dr. Khera wrote.
Rohan Khera, MD, a cardiology fellow at the University of Texas (Dallas) Southwestern Medical Center in, wrote about his experience with preprints for BMJ Blogs . Dr. Khera had no conflicts of interest to disclose.
This study addressing hypertension guideline changes is unique because it was initially published on a public preprint server.
Preprints are common in some scientific areas, but uncommon in major medical journals. They allow investigators to share research, quickly and openly, for critique and feedback before standard peer review and publication.
In the case of this study, researchers analyzed the public health implications of the anticipated changes to the 2017 ACC/AHA hypertension guidelines in two nationally representative data sets from the United States and China.
The authors quickly finalized their manuscript right after the revised hypertension guidelines were released. They chose the preprint approach because they realized their research would be immediately relevant to the discussion that followed, first author Rohan Khera, MD, recounted on BMJ Blogs.
“The traditional approach of submitting to a medical journal would mean being out of the public eye for several months,” Dr. Khera said in his post. “The preprint platform offered us an excellent opportunity of ensuring early dissemination of our research study in its entirety, while we sought its evaluation by peer reviewers and the refinement by a medical journal.”
The manuscript was submitted via a Web-based system and was publicly available 2 hours later on the same day the guidelines were published. The researchers received comments and suggestions on the preprint, some of which were incorporated into the final manuscript they submitted for peer review.
Then the manuscript went through the usual iterative peer review process; however, the preprint was still available online to guide other investigators and limit duplication of effort, Dr. Khera said in his blog post.
That contrasts with another recent experience in which Dr. Khera and his colleagues performed work that “failed to inform” ongoing policy discussions, and other research efforts, while they waited for eventual publication.
“We hope that more journals will accept the benefits of science that is publicly available while journal editors and peer reviewers carry out their critical role of improving both the quality and the impact of these scientific contributions,” Dr. Khera wrote.
Rohan Khera, MD, a cardiology fellow at the University of Texas (Dallas) Southwestern Medical Center in, wrote about his experience with preprints for BMJ Blogs . Dr. Khera had no conflicts of interest to disclose.
A new analysis estimates that adopting the 2017 ACC/AHA hypertension guidelines would add 15.6 million Americans to the ranks of the hypertensives, and half of those would be candidates for treatment.
Similar increases would occur in other countries, according to study authors, who analyzed two large datasets from the United States and China.
That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, meaning more than half of people aged 45-75 years in both countries would be classified as having hypertension, according to the researchers, led by Harlan M. Krumholz, MD, of the Center for Outcomes Research and Evaluation at Yale–New Haven (Conn.) Hospital and the section of cardiovascular medicine at Yale
An additional 7.5 million Americans would be recommended for treatment under the new lower treatment thresholds, with a correspondingly large increase in the Chinese population, according to results published in the BMJ.
The guideline changes are “not firmly rooted in evidence” and could have health policy implications that include strain on public health programs, Dr. Krumholz and his colleagues said in their report on the study.
“The change occurs at a time when both countries have substantial numbers of people who are not aware of having hypertension, and who have hypertension that is not controlled, even according to the previous standards,” they wrote.
The analysis by Dr. Krumholz and his colleagues was based on the two most recent cycles of the U.S. National Health and Nutrition Examination Survey (NHANES), representing 2013-2014 and 2015-2016 periods, as well as the China Health and Retirement Longitudinal Study (CHARLS) in 2011-2012.
Under the new ACC/AHA guidelines, they found, 70.1 million Americans aged 45-65 years would be classified as hypertensive, representing 63% of that age group. That’s a 27% relative increase over the 55.3 million individuals, or 49.7%, with hypertension as defined in the JNC-8 guidelines.
In addition, 15.6 million persons would be classified as eligible for treatment but not receiving it, up from 8.1 million under the JNC-8 guidance.
Previous estimates projected a far greater jump in new hypertension classifications, including one that used data from the National Health and Nutrition Examination Survey, antihypertensive clinical trials, and population-based cohort studies. That study estimated that 31 million people would newly carry the label (JAMA Cardiol. 2018 May 23; doi: 10.1001/jamacardio.2018.1240.)
In the current analysis, in China, 267 million aged 45-65 years (55% of that age group) would be classified with hypertension under the ACC/AHA guidelines, a relative increase of 45% over the JNC-8 guidelines, while the number of candidates for treatment would be 129 million, up from 74.5 million under the earlier guidelines.
Dr. Krumholz noted that the ACC/AHA guideline changes were prompted by results from the SPRINT trial. However, the improvements in outcomes seen in SPRINT, which included patients at high risk for cardiovascular events but without diabetes, have not been observed in individuals at low or intermediate risk, or in those with diabetes, they said.
“Expanding the pool of patients who merit treatment to include those at low risk could potentially render public health programs less efficient and viable,” they wrote in a discussion of health policy implications.
The new guidelines also put millions at risk of the “psychological morbidity” that comes with the label of a chronic disease, and at risk for more adverse events caused by inappropriate use of drug therapy, they added.
Dr. Krumholz reported research agreements from Medtronic and from Johnson and Johnson (Janssen) through Yale University, and a grant from the Food and Drug Administration and Medtronic. He reported other disclosures related to UnitedHealth, the IBM Watson Health Life Sciences Board, Element Science, Aetna, and Hugo, a personal health information platform he founded. First author Rohan Khera, MD, reported support from the National Institutes of Health.
SOURCE: Khera R et al. BMJ. 2018 Jul 11;362:k2357
This article was updated 7/19/18.
A new analysis estimates that adopting the 2017 ACC/AHA hypertension guidelines would add 15.6 million Americans to the ranks of the hypertensives, and half of those would be candidates for treatment.
Similar increases would occur in other countries, according to study authors, who analyzed two large datasets from the United States and China.
That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, meaning more than half of people aged 45-75 years in both countries would be classified as having hypertension, according to the researchers, led by Harlan M. Krumholz, MD, of the Center for Outcomes Research and Evaluation at Yale–New Haven (Conn.) Hospital and the section of cardiovascular medicine at Yale
An additional 7.5 million Americans would be recommended for treatment under the new lower treatment thresholds, with a correspondingly large increase in the Chinese population, according to results published in the BMJ.
The guideline changes are “not firmly rooted in evidence” and could have health policy implications that include strain on public health programs, Dr. Krumholz and his colleagues said in their report on the study.
“The change occurs at a time when both countries have substantial numbers of people who are not aware of having hypertension, and who have hypertension that is not controlled, even according to the previous standards,” they wrote.
The analysis by Dr. Krumholz and his colleagues was based on the two most recent cycles of the U.S. National Health and Nutrition Examination Survey (NHANES), representing 2013-2014 and 2015-2016 periods, as well as the China Health and Retirement Longitudinal Study (CHARLS) in 2011-2012.
Under the new ACC/AHA guidelines, they found, 70.1 million Americans aged 45-65 years would be classified as hypertensive, representing 63% of that age group. That’s a 27% relative increase over the 55.3 million individuals, or 49.7%, with hypertension as defined in the JNC-8 guidelines.
In addition, 15.6 million persons would be classified as eligible for treatment but not receiving it, up from 8.1 million under the JNC-8 guidance.
Previous estimates projected a far greater jump in new hypertension classifications, including one that used data from the National Health and Nutrition Examination Survey, antihypertensive clinical trials, and population-based cohort studies. That study estimated that 31 million people would newly carry the label (JAMA Cardiol. 2018 May 23; doi: 10.1001/jamacardio.2018.1240.)
In the current analysis, in China, 267 million aged 45-65 years (55% of that age group) would be classified with hypertension under the ACC/AHA guidelines, a relative increase of 45% over the JNC-8 guidelines, while the number of candidates for treatment would be 129 million, up from 74.5 million under the earlier guidelines.
Dr. Krumholz noted that the ACC/AHA guideline changes were prompted by results from the SPRINT trial. However, the improvements in outcomes seen in SPRINT, which included patients at high risk for cardiovascular events but without diabetes, have not been observed in individuals at low or intermediate risk, or in those with diabetes, they said.
“Expanding the pool of patients who merit treatment to include those at low risk could potentially render public health programs less efficient and viable,” they wrote in a discussion of health policy implications.
The new guidelines also put millions at risk of the “psychological morbidity” that comes with the label of a chronic disease, and at risk for more adverse events caused by inappropriate use of drug therapy, they added.
Dr. Krumholz reported research agreements from Medtronic and from Johnson and Johnson (Janssen) through Yale University, and a grant from the Food and Drug Administration and Medtronic. He reported other disclosures related to UnitedHealth, the IBM Watson Health Life Sciences Board, Element Science, Aetna, and Hugo, a personal health information platform he founded. First author Rohan Khera, MD, reported support from the National Institutes of Health.
SOURCE: Khera R et al. BMJ. 2018 Jul 11;362:k2357
This article was updated 7/19/18.
FROM THE BMJ
Key clinical point: The 2017 ACC/AHA hypertension guidelines could dramatically increase the number of individuals with hypertension and candidates for treatment.
Major finding: The number of individuals with untreated hypertension increased from 8.1 million to 15.6 million.
Study details: A cross-sectional study of adults in nationally representative databases in the United States (NHANES) and China (CHARLS).
Disclosures: Authors reported disclosures related to Medtronic, Johnson and Johnson (Janssen), the Food and Drug Administration, UnitedHealth, the IBM Watson Health Life Sciences Board, Element Science, Aetna, and Hugo.
Source: Khera R et al. BMJ 2018;362:k2357.
IVF linked to slight increase in risk of some cancers
A large observational study from Great Britain paints a mixed picture of cancer risks associated with assisted reproduction technologies such as in vitro fertilization (IVF).
Among nearly 256,000 women who had assisted reproduction over a 2-decade period and were followed for more than 2.25 million person-years, there was no significant increase in risk of uterine cancers or invasive breast cancers.
However, these women were at slight but significantly increased risk for in situ breast cancers and invasive or borderline ovarian cancers, although the ovarian tumors may be related more to patient factors than to the assisted reproduction technology itself, reported Alastair Sutcliffe, MD, PhD, from University College London, and his colleagues.
“We were not able to distinguish between a genuine increase in risk of borderline ovarian tumors and other explanations including surveillance bias. Further investigation of this and longer follow-up is warranted to continue monitoring these important outcomes in this ever-growing population,” they wrote in BMJ.
Women who undergo IVF and related procedures are typically exposed to high levels of estradiol, luteinizing hormone, follicle-stimulating hormone, and multiple ovarian punctures, all of which are potentially carcinogenic, the authors noted.
Previous studies of cancer risk in women who undergo assisted reproduction treatment have had conflicting or inconsistent results and lacked information on potential confounders, they pointed out.
To get a better sense of the potential risks, the investigators looked at linked data from the United Kingdom’s Human Fertilization and Embryology Authority and national cancer registries. They identified a total of 255,786 women treated from 1991 through 2010. Total follow-up was for 2,257,789 person-years.
They found that, during an average 8.8 years of follow-up, women had no significant increase in risk of tumors of the uterine corpus, with 164 cancers observed vs. 146.9 expected, for a standardized incidence ratio (SIR) of 1.12 (95% confidence interval, 0.95-1.30).
Similarly, there was no significant increase in risk of either breast cancer overall (2,578 observed vs. 2,641.2 expected; SIR, 0.98; 95% CI, 0.94-1.01) or invasive breast cancer (2,272 observed vs. 2,371.4 expected; SIR, 0.96; 95% CI, 0.92-1.00).
As noted, however, there was an increased risk of in situ breast cancer with 291 vs. 253.5 cases, respectively, translating into a SIR of 1.15 (95% CI, 1.02-1.29), for an absolute excess risk (AER) of 1.7 cases per 100,000 person-years, associated with an increasing number of treatment cycles (P = .03).
Additionally, the women in the study had an increased risk of ovarian cancer with an observed incidence of 405 vs. 291.82 expected, for an SIR of 1.39 (95% CI, 1.26-1.53) and an AER of 5.0 cases per 100,000 person-years.
There was a significantly increased risk for both invasive tumors, with 264 cases vs. 188.1 expected, for an SIR of 1.40 (95% CI, 1.24-1.58) and an AER of 3.4 cases per 100,000 person-years, and borderline ovarian cancers, with 141 vs. 103.7, for an SIR of 1.36 (95% CI, 1.15-1.60) and an AER of 1.7 cases per 100,000 person-years.
Increased risks of ovarian tumors were limited to women with endometriosis, low parity, or both. This study found no increased risk of any ovarian tumor in women treated because of only male-factor or unexplained infertility.
Women who had previously given birth and did not have a diagnosis of endometriosis had no increase in risk for ovarian cancer. Instead, increased risk appeared to be limited to women with endometriosis, few or no births (low parity), or both.
The authors emphasized that ongoing monitoring of outcomes for women who have undergone assisted reproduction is essential.
The study was funded by Cancer Research UK and the National Institute for Health Research, and supported by the NIHR Biomedical Research Centre at Great Ormond Street Hospital for Children NHS Foundation Trust and University College London. Three authors reported personal fees or royalties from entities not involved in the study.
SOURCE: Williams CL et al. BMJ. 2018;362:k2644.
A large observational study from Great Britain paints a mixed picture of cancer risks associated with assisted reproduction technologies such as in vitro fertilization (IVF).
Among nearly 256,000 women who had assisted reproduction over a 2-decade period and were followed for more than 2.25 million person-years, there was no significant increase in risk of uterine cancers or invasive breast cancers.
However, these women were at slight but significantly increased risk for in situ breast cancers and invasive or borderline ovarian cancers, although the ovarian tumors may be related more to patient factors than to the assisted reproduction technology itself, reported Alastair Sutcliffe, MD, PhD, from University College London, and his colleagues.
“We were not able to distinguish between a genuine increase in risk of borderline ovarian tumors and other explanations including surveillance bias. Further investigation of this and longer follow-up is warranted to continue monitoring these important outcomes in this ever-growing population,” they wrote in BMJ.
Women who undergo IVF and related procedures are typically exposed to high levels of estradiol, luteinizing hormone, follicle-stimulating hormone, and multiple ovarian punctures, all of which are potentially carcinogenic, the authors noted.
Previous studies of cancer risk in women who undergo assisted reproduction treatment have had conflicting or inconsistent results and lacked information on potential confounders, they pointed out.
To get a better sense of the potential risks, the investigators looked at linked data from the United Kingdom’s Human Fertilization and Embryology Authority and national cancer registries. They identified a total of 255,786 women treated from 1991 through 2010. Total follow-up was for 2,257,789 person-years.
They found that, during an average 8.8 years of follow-up, women had no significant increase in risk of tumors of the uterine corpus, with 164 cancers observed vs. 146.9 expected, for a standardized incidence ratio (SIR) of 1.12 (95% confidence interval, 0.95-1.30).
Similarly, there was no significant increase in risk of either breast cancer overall (2,578 observed vs. 2,641.2 expected; SIR, 0.98; 95% CI, 0.94-1.01) or invasive breast cancer (2,272 observed vs. 2,371.4 expected; SIR, 0.96; 95% CI, 0.92-1.00).
As noted, however, there was an increased risk of in situ breast cancer with 291 vs. 253.5 cases, respectively, translating into a SIR of 1.15 (95% CI, 1.02-1.29), for an absolute excess risk (AER) of 1.7 cases per 100,000 person-years, associated with an increasing number of treatment cycles (P = .03).
Additionally, the women in the study had an increased risk of ovarian cancer with an observed incidence of 405 vs. 291.82 expected, for an SIR of 1.39 (95% CI, 1.26-1.53) and an AER of 5.0 cases per 100,000 person-years.
There was a significantly increased risk for both invasive tumors, with 264 cases vs. 188.1 expected, for an SIR of 1.40 (95% CI, 1.24-1.58) and an AER of 3.4 cases per 100,000 person-years, and borderline ovarian cancers, with 141 vs. 103.7, for an SIR of 1.36 (95% CI, 1.15-1.60) and an AER of 1.7 cases per 100,000 person-years.
Increased risks of ovarian tumors were limited to women with endometriosis, low parity, or both. This study found no increased risk of any ovarian tumor in women treated because of only male-factor or unexplained infertility.
Women who had previously given birth and did not have a diagnosis of endometriosis had no increase in risk for ovarian cancer. Instead, increased risk appeared to be limited to women with endometriosis, few or no births (low parity), or both.
The authors emphasized that ongoing monitoring of outcomes for women who have undergone assisted reproduction is essential.
The study was funded by Cancer Research UK and the National Institute for Health Research, and supported by the NIHR Biomedical Research Centre at Great Ormond Street Hospital for Children NHS Foundation Trust and University College London. Three authors reported personal fees or royalties from entities not involved in the study.
SOURCE: Williams CL et al. BMJ. 2018;362:k2644.
A large observational study from Great Britain paints a mixed picture of cancer risks associated with assisted reproduction technologies such as in vitro fertilization (IVF).
Among nearly 256,000 women who had assisted reproduction over a 2-decade period and were followed for more than 2.25 million person-years, there was no significant increase in risk of uterine cancers or invasive breast cancers.
However, these women were at slight but significantly increased risk for in situ breast cancers and invasive or borderline ovarian cancers, although the ovarian tumors may be related more to patient factors than to the assisted reproduction technology itself, reported Alastair Sutcliffe, MD, PhD, from University College London, and his colleagues.
“We were not able to distinguish between a genuine increase in risk of borderline ovarian tumors and other explanations including surveillance bias. Further investigation of this and longer follow-up is warranted to continue monitoring these important outcomes in this ever-growing population,” they wrote in BMJ.
Women who undergo IVF and related procedures are typically exposed to high levels of estradiol, luteinizing hormone, follicle-stimulating hormone, and multiple ovarian punctures, all of which are potentially carcinogenic, the authors noted.
Previous studies of cancer risk in women who undergo assisted reproduction treatment have had conflicting or inconsistent results and lacked information on potential confounders, they pointed out.
To get a better sense of the potential risks, the investigators looked at linked data from the United Kingdom’s Human Fertilization and Embryology Authority and national cancer registries. They identified a total of 255,786 women treated from 1991 through 2010. Total follow-up was for 2,257,789 person-years.
They found that, during an average 8.8 years of follow-up, women had no significant increase in risk of tumors of the uterine corpus, with 164 cancers observed vs. 146.9 expected, for a standardized incidence ratio (SIR) of 1.12 (95% confidence interval, 0.95-1.30).
Similarly, there was no significant increase in risk of either breast cancer overall (2,578 observed vs. 2,641.2 expected; SIR, 0.98; 95% CI, 0.94-1.01) or invasive breast cancer (2,272 observed vs. 2,371.4 expected; SIR, 0.96; 95% CI, 0.92-1.00).
As noted, however, there was an increased risk of in situ breast cancer with 291 vs. 253.5 cases, respectively, translating into a SIR of 1.15 (95% CI, 1.02-1.29), for an absolute excess risk (AER) of 1.7 cases per 100,000 person-years, associated with an increasing number of treatment cycles (P = .03).
Additionally, the women in the study had an increased risk of ovarian cancer with an observed incidence of 405 vs. 291.82 expected, for an SIR of 1.39 (95% CI, 1.26-1.53) and an AER of 5.0 cases per 100,000 person-years.
There was a significantly increased risk for both invasive tumors, with 264 cases vs. 188.1 expected, for an SIR of 1.40 (95% CI, 1.24-1.58) and an AER of 3.4 cases per 100,000 person-years, and borderline ovarian cancers, with 141 vs. 103.7, for an SIR of 1.36 (95% CI, 1.15-1.60) and an AER of 1.7 cases per 100,000 person-years.
Increased risks of ovarian tumors were limited to women with endometriosis, low parity, or both. This study found no increased risk of any ovarian tumor in women treated because of only male-factor or unexplained infertility.
Women who had previously given birth and did not have a diagnosis of endometriosis had no increase in risk for ovarian cancer. Instead, increased risk appeared to be limited to women with endometriosis, few or no births (low parity), or both.
The authors emphasized that ongoing monitoring of outcomes for women who have undergone assisted reproduction is essential.
The study was funded by Cancer Research UK and the National Institute for Health Research, and supported by the NIHR Biomedical Research Centre at Great Ormond Street Hospital for Children NHS Foundation Trust and University College London. Three authors reported personal fees or royalties from entities not involved in the study.
SOURCE: Williams CL et al. BMJ. 2018;362:k2644.
FROM BMJ
Key clinical point: Assisted reproductive technologies may be linked to increased risk for in situ breast and ovarian cancers.
Major finding: The standardized incidence ratios (observed vs. expected cases) for invasive and borderline ovarian tumors were 1.40 and 1.41, respectively, both statistically significant.
Study details: Observational study with linked fertility clinic and cancer registry data on 255,786 women with total follow-up of 2,257,789 person-years.
Disclosures: The study was funded by Cancer Research UK and the National Institute for Health Research, and supported by the NIHR Biomedical Research Centre at Great Ormond Street Hospital for Children NHS Foundation Trust and University College London. Three authors reported personal fees or royalties from entities not involved in the study.
Source: Williams CL et al. BMJ. 2018;362:k2644.
Abatacept loses ALLURE in lupus nephritis
AMSTERDAM – Abatacept used on top of the standard of care did not improve the primary endpoint of a complete renal response versus placebo in the ALLURE phase 3 study.
Criteria for a complete renal response (CRR) at 1 year was met by 35.1% of abatacept-treated and 33.5% of placebo-treated patients (P = .73). CRR criteria included having a urine protein to creatinine ratio (UPCR) of less than 0.5, a normal estimated glomerular filtration rate (eGFR) or an eGFR of 85% or more of baseline values, no cellular casts, and a daily corticosteroid dose of 10 mg or less.
“We also saw a more rapid decline in proteinuria in those people treated with abatacept, and that seemed to be sustained over the course of the study,” said Dr. Furie, professor of medicine at Hofstra University, Hempstead, N.Y., chief of the division of rheumatology at Northwell Health in Great Neck, N.Y., and a professor at the Center for Autoimmune, Musculoskeletal, and Hematopoietic Diseases in the Feinstein Institute for Medical Research in Manhasset, N.Y. After about 12 weeks, the adjusted mean change in UPCR from baseline was –2.5 for abatacept and –2.0 for placebo; the values at 1 year were a respective –2.95 vs. –2.68 and at 2 years were –3.13 vs. –2.72.
Renal function was not negatively impacted by treatment with abatacept, with about a 5%-8% increase in eGFR seen in both groups.
Furthermore, improvements in lupus-related biomarkers were more pronounced in patients treated with abatacept than placebo, Dr. Furie said. This included a greater decrease in anti–double-stranded DNA autoantibody titers and an increase in complement C3 and C4 levels.
Eric Morand, MD, who was not involved in the ALLURE study, commented during discussion that the main result of the study was “very sad.”
Dr. Morand of Monash University in Melbourne observed that the duration of renal disease at study entry was about 14 months and that around 38% had been previously treated with mycophenolate mofetil (MMF). So, could this have influenced the findings?
Dr. Furie was unable to answer the question but confirmed that MMF was one of two background medications given in the trial, at an oral dose of 1.5 g/day, alongside of oral prednisone up to 60-mg daily.
ALLURE was a 2-year randomized, double-blind study with an open-ended, blinded, long-term extension in 405 patients with active class III or IV lupus nephritis. The aim of the trial was to determine the efficacy and safety of abatacept versus placebo in the treatment of active proliferative lupus nephritis.
Abatacept was given intravenously, first at a dose of 30 mg/kg on days 1, 15, 29, and 57, and then at a dose of 10 mg/kg every 4 weeks.
In terms of safety, 14 deaths occurred during the course of the study and its long-term extension. Seven abatacept patients died in year 1, two of whom died more than 56 days after discontinuing the study drug. Five patients in the placebo group died in year 1, one in year 2, and one in the long-term extension. Rates of any or serious adverse events were similar among the groups, decreasing over time.
“The safety signals were really no different to what we already know about abatacept,” Dr. Furie said. As for the future, more analyses from the trial can be expected, he added.
The study was sponsored by Bristol-Myers Squibb. Dr. Furie disclosed receiving grant or research support from, and acting as a consultant to, the company. All but 3 of the study’s 12 authors had financial ties to many pharmaceutical companies, some of which included Bristol-Myers Squibb. Two authors are employees of Bristol-Myers Squibb. Dr. Monash was not involved in the ALLURE study but has received research support from Bristol-Myers Squibb, among other pharmaceutical companies.
SOURCE: Furie RA et al. EULAR 2018. Abstract OP0253.
AMSTERDAM – Abatacept used on top of the standard of care did not improve the primary endpoint of a complete renal response versus placebo in the ALLURE phase 3 study.
Criteria for a complete renal response (CRR) at 1 year was met by 35.1% of abatacept-treated and 33.5% of placebo-treated patients (P = .73). CRR criteria included having a urine protein to creatinine ratio (UPCR) of less than 0.5, a normal estimated glomerular filtration rate (eGFR) or an eGFR of 85% or more of baseline values, no cellular casts, and a daily corticosteroid dose of 10 mg or less.
“We also saw a more rapid decline in proteinuria in those people treated with abatacept, and that seemed to be sustained over the course of the study,” said Dr. Furie, professor of medicine at Hofstra University, Hempstead, N.Y., chief of the division of rheumatology at Northwell Health in Great Neck, N.Y., and a professor at the Center for Autoimmune, Musculoskeletal, and Hematopoietic Diseases in the Feinstein Institute for Medical Research in Manhasset, N.Y. After about 12 weeks, the adjusted mean change in UPCR from baseline was –2.5 for abatacept and –2.0 for placebo; the values at 1 year were a respective –2.95 vs. –2.68 and at 2 years were –3.13 vs. –2.72.
Renal function was not negatively impacted by treatment with abatacept, with about a 5%-8% increase in eGFR seen in both groups.
Furthermore, improvements in lupus-related biomarkers were more pronounced in patients treated with abatacept than placebo, Dr. Furie said. This included a greater decrease in anti–double-stranded DNA autoantibody titers and an increase in complement C3 and C4 levels.
Eric Morand, MD, who was not involved in the ALLURE study, commented during discussion that the main result of the study was “very sad.”
Dr. Morand of Monash University in Melbourne observed that the duration of renal disease at study entry was about 14 months and that around 38% had been previously treated with mycophenolate mofetil (MMF). So, could this have influenced the findings?
Dr. Furie was unable to answer the question but confirmed that MMF was one of two background medications given in the trial, at an oral dose of 1.5 g/day, alongside of oral prednisone up to 60-mg daily.
ALLURE was a 2-year randomized, double-blind study with an open-ended, blinded, long-term extension in 405 patients with active class III or IV lupus nephritis. The aim of the trial was to determine the efficacy and safety of abatacept versus placebo in the treatment of active proliferative lupus nephritis.
Abatacept was given intravenously, first at a dose of 30 mg/kg on days 1, 15, 29, and 57, and then at a dose of 10 mg/kg every 4 weeks.
In terms of safety, 14 deaths occurred during the course of the study and its long-term extension. Seven abatacept patients died in year 1, two of whom died more than 56 days after discontinuing the study drug. Five patients in the placebo group died in year 1, one in year 2, and one in the long-term extension. Rates of any or serious adverse events were similar among the groups, decreasing over time.
“The safety signals were really no different to what we already know about abatacept,” Dr. Furie said. As for the future, more analyses from the trial can be expected, he added.
The study was sponsored by Bristol-Myers Squibb. Dr. Furie disclosed receiving grant or research support from, and acting as a consultant to, the company. All but 3 of the study’s 12 authors had financial ties to many pharmaceutical companies, some of which included Bristol-Myers Squibb. Two authors are employees of Bristol-Myers Squibb. Dr. Monash was not involved in the ALLURE study but has received research support from Bristol-Myers Squibb, among other pharmaceutical companies.
SOURCE: Furie RA et al. EULAR 2018. Abstract OP0253.
AMSTERDAM – Abatacept used on top of the standard of care did not improve the primary endpoint of a complete renal response versus placebo in the ALLURE phase 3 study.
Criteria for a complete renal response (CRR) at 1 year was met by 35.1% of abatacept-treated and 33.5% of placebo-treated patients (P = .73). CRR criteria included having a urine protein to creatinine ratio (UPCR) of less than 0.5, a normal estimated glomerular filtration rate (eGFR) or an eGFR of 85% or more of baseline values, no cellular casts, and a daily corticosteroid dose of 10 mg or less.
“We also saw a more rapid decline in proteinuria in those people treated with abatacept, and that seemed to be sustained over the course of the study,” said Dr. Furie, professor of medicine at Hofstra University, Hempstead, N.Y., chief of the division of rheumatology at Northwell Health in Great Neck, N.Y., and a professor at the Center for Autoimmune, Musculoskeletal, and Hematopoietic Diseases in the Feinstein Institute for Medical Research in Manhasset, N.Y. After about 12 weeks, the adjusted mean change in UPCR from baseline was –2.5 for abatacept and –2.0 for placebo; the values at 1 year were a respective –2.95 vs. –2.68 and at 2 years were –3.13 vs. –2.72.
Renal function was not negatively impacted by treatment with abatacept, with about a 5%-8% increase in eGFR seen in both groups.
Furthermore, improvements in lupus-related biomarkers were more pronounced in patients treated with abatacept than placebo, Dr. Furie said. This included a greater decrease in anti–double-stranded DNA autoantibody titers and an increase in complement C3 and C4 levels.
Eric Morand, MD, who was not involved in the ALLURE study, commented during discussion that the main result of the study was “very sad.”
Dr. Morand of Monash University in Melbourne observed that the duration of renal disease at study entry was about 14 months and that around 38% had been previously treated with mycophenolate mofetil (MMF). So, could this have influenced the findings?
Dr. Furie was unable to answer the question but confirmed that MMF was one of two background medications given in the trial, at an oral dose of 1.5 g/day, alongside of oral prednisone up to 60-mg daily.
ALLURE was a 2-year randomized, double-blind study with an open-ended, blinded, long-term extension in 405 patients with active class III or IV lupus nephritis. The aim of the trial was to determine the efficacy and safety of abatacept versus placebo in the treatment of active proliferative lupus nephritis.
Abatacept was given intravenously, first at a dose of 30 mg/kg on days 1, 15, 29, and 57, and then at a dose of 10 mg/kg every 4 weeks.
In terms of safety, 14 deaths occurred during the course of the study and its long-term extension. Seven abatacept patients died in year 1, two of whom died more than 56 days after discontinuing the study drug. Five patients in the placebo group died in year 1, one in year 2, and one in the long-term extension. Rates of any or serious adverse events were similar among the groups, decreasing over time.
“The safety signals were really no different to what we already know about abatacept,” Dr. Furie said. As for the future, more analyses from the trial can be expected, he added.
The study was sponsored by Bristol-Myers Squibb. Dr. Furie disclosed receiving grant or research support from, and acting as a consultant to, the company. All but 3 of the study’s 12 authors had financial ties to many pharmaceutical companies, some of which included Bristol-Myers Squibb. Two authors are employees of Bristol-Myers Squibb. Dr. Monash was not involved in the ALLURE study but has received research support from Bristol-Myers Squibb, among other pharmaceutical companies.
SOURCE: Furie RA et al. EULAR 2018. Abstract OP0253.
REPORTING FROM THE EULAR 2018 CONGRESS
Key clinical point: Abatacept treatment did not improve the complete renal response rate versus placebo.
Major finding: A complete renal response rate at 1 year was seen in 35.1% of abatacept-treated and 33.5% of placebo-treated patients (P = .73).
Study details: The phase 3 ALLURE study, a 2-year, randomized, double-blind study with an open-ended, blinded, long-term extension in 405 patients with active class III or IV lupus nephritis.
Disclosures: The study was sponsored by Bristol-Myers Squibb. Dr. Furie disclosed receiving grant or research support from, and acting as a consultant to, the company. All but 3 of the study’s 12 authors had financial ties to many pharmaceutical companies, some of which included Bristol-Myers Squibb. Two authors are employees of Bristol-Myers Squibb. Dr. Monash was not involved in the ALLURE study but has received research support from Bristol-Myers Squibb, among other pharmaceutical companies.
Source: Furie RA et al. EULAR 2018. Abstract OP0253.
Primary efficacy not met by new M. tuberculosis vaccine strategies
Vaccination may have reduced the rate of sustained Mycobacterium tuberculosis infection in a recent randomized, placebo-controlled clinical trial conducted in a high-risk setting for tuberculosis transmission, despite not meeting the primary endpoint of the study.
In adolescents who had received the bacille Calmette-Guérin (BCG) vaccine in infancy, BCG revaccination reduced the rate of sustained conversion of QuantiFERON-TB Gold In-Tube assay (QFT), a test that is thought to reflect sustained M. tuberculosis infection.
The study also evaluated a candidate subunit vaccine, H4:IC31, which also reduced the rate of sustained QFT conversion, though the efficacy estimate did not reach statistical significance, investigators reported.
Neither H4:IC31 nor BCG revaccination prevented initial QFT conversion, the primary endpoint of the study; however, both vaccines were immunogenic, they said.
Moreover, the significantly reduced rate of sustained conversion with BCG revaccination provides a “promising signal,” study authors said in the New England Journal of Medicine.
“The durability of this important finding and potential public health significance for protection against tuberculosis disease warrants epidemiologic modeling and further clinical evaluation,” wrote Elisa Nemes, PhD, of the South African Tuberculosis Vaccine Initiative, which is part of the Institute of Infectious Disease and Molecular Medicine at the University of Cape Town (South Africa), and her coauthors.
Similarly, the nonsignificantly reduced rate of sustained QFT conversion seen with H4:IC31 suggested that subunit vaccines can have a biologic effect in this setting, which may inform development of new tuberculosis vaccines, Dr. Nemes and her colleagues added.
The phase 2 trial included 990 adolescents in South Africa who had undergone neonatal BCG vaccination. They were randomly assigned to receive BCG revaccination, H4:IC31 vaccine, or placebo.
Neither vaccine met the primary efficacy criterion based on initial QFT conversion rates, which were 13.1% for BCG revaccination, 14.3% for H4:IC31 vaccine, and 15.8% for placebo.
For the secondary endpoint of sustained QFT conversion, the efficacy of BCG revaccination was 45.4% (95% confidence interval, 6.4%-68.1%; P = .03), while the efficacy of H4:IC31 vaccine was 34.2% (95% CI, –10.4% to 60.7%; P = .11).
“These encouraging findings provide an impetus to reevaluate the use of BCG revaccination of populations that are free of M. tuberculosis infection for the prevention of disease,” Dr. Nemes and her coauthors wrote in their report.
Revaccination with BCG was associated with more adverse events, compared with the other groups, although adverse events in the trial were predominantly injection-site reactions that were mild to moderate in severity, investigators reported. There were no serious adverse events judged by investigators to be related to trial vaccine.
Taken together, these results raise important questions regarding the potential benefits of vaccine-mediated prevention of M. tuberculosis infection for control of tuberculosis disease, according to Dr. Nemes and her coauthors.
However, interpretation of the findings is limited because there is no definitive test for M. tuberculosis infection.
Recent infection diagnosed by tuberculin skin test or QFT conversion has been associated with higher risk of disease, compared with nonconversion, according to investigators, while reversion to a negative tuberculin skin test correlates with infection containment and lower risk of tuberculosis.
“Although the clinical significance of QFT reversion remains to be established, we propose that sustained QFT conversion more likely represents sustained M. tuberculosis infection and a higher risk of progression to disease than transient QFT conversion,” they wrote.
The study was supported by Aeras, Sanofi Pasteur, the Bill & Melinda Gates Foundation, the Government of the Netherlands Directorate-General for International Cooperation and Development, and the United Kingdom Department for International Development. Study authors reported disclosures related to GlaxoSmithKline, Sanofi Pasteur, and Aeras.
SOURCE: Nemes E et al. N Engl J Med. 2018;379:138-49.
Vaccination may have reduced the rate of sustained Mycobacterium tuberculosis infection in a recent randomized, placebo-controlled clinical trial conducted in a high-risk setting for tuberculosis transmission, despite not meeting the primary endpoint of the study.
In adolescents who had received the bacille Calmette-Guérin (BCG) vaccine in infancy, BCG revaccination reduced the rate of sustained conversion of QuantiFERON-TB Gold In-Tube assay (QFT), a test that is thought to reflect sustained M. tuberculosis infection.
The study also evaluated a candidate subunit vaccine, H4:IC31, which also reduced the rate of sustained QFT conversion, though the efficacy estimate did not reach statistical significance, investigators reported.
Neither H4:IC31 nor BCG revaccination prevented initial QFT conversion, the primary endpoint of the study; however, both vaccines were immunogenic, they said.
Moreover, the significantly reduced rate of sustained conversion with BCG revaccination provides a “promising signal,” study authors said in the New England Journal of Medicine.
“The durability of this important finding and potential public health significance for protection against tuberculosis disease warrants epidemiologic modeling and further clinical evaluation,” wrote Elisa Nemes, PhD, of the South African Tuberculosis Vaccine Initiative, which is part of the Institute of Infectious Disease and Molecular Medicine at the University of Cape Town (South Africa), and her coauthors.
Similarly, the nonsignificantly reduced rate of sustained QFT conversion seen with H4:IC31 suggested that subunit vaccines can have a biologic effect in this setting, which may inform development of new tuberculosis vaccines, Dr. Nemes and her colleagues added.
The phase 2 trial included 990 adolescents in South Africa who had undergone neonatal BCG vaccination. They were randomly assigned to receive BCG revaccination, H4:IC31 vaccine, or placebo.
Neither vaccine met the primary efficacy criterion based on initial QFT conversion rates, which were 13.1% for BCG revaccination, 14.3% for H4:IC31 vaccine, and 15.8% for placebo.
For the secondary endpoint of sustained QFT conversion, the efficacy of BCG revaccination was 45.4% (95% confidence interval, 6.4%-68.1%; P = .03), while the efficacy of H4:IC31 vaccine was 34.2% (95% CI, –10.4% to 60.7%; P = .11).
“These encouraging findings provide an impetus to reevaluate the use of BCG revaccination of populations that are free of M. tuberculosis infection for the prevention of disease,” Dr. Nemes and her coauthors wrote in their report.
Revaccination with BCG was associated with more adverse events, compared with the other groups, although adverse events in the trial were predominantly injection-site reactions that were mild to moderate in severity, investigators reported. There were no serious adverse events judged by investigators to be related to trial vaccine.
Taken together, these results raise important questions regarding the potential benefits of vaccine-mediated prevention of M. tuberculosis infection for control of tuberculosis disease, according to Dr. Nemes and her coauthors.
However, interpretation of the findings is limited because there is no definitive test for M. tuberculosis infection.
Recent infection diagnosed by tuberculin skin test or QFT conversion has been associated with higher risk of disease, compared with nonconversion, according to investigators, while reversion to a negative tuberculin skin test correlates with infection containment and lower risk of tuberculosis.
“Although the clinical significance of QFT reversion remains to be established, we propose that sustained QFT conversion more likely represents sustained M. tuberculosis infection and a higher risk of progression to disease than transient QFT conversion,” they wrote.
The study was supported by Aeras, Sanofi Pasteur, the Bill & Melinda Gates Foundation, the Government of the Netherlands Directorate-General for International Cooperation and Development, and the United Kingdom Department for International Development. Study authors reported disclosures related to GlaxoSmithKline, Sanofi Pasteur, and Aeras.
SOURCE: Nemes E et al. N Engl J Med. 2018;379:138-49.
Vaccination may have reduced the rate of sustained Mycobacterium tuberculosis infection in a recent randomized, placebo-controlled clinical trial conducted in a high-risk setting for tuberculosis transmission, despite not meeting the primary endpoint of the study.
In adolescents who had received the bacille Calmette-Guérin (BCG) vaccine in infancy, BCG revaccination reduced the rate of sustained conversion of QuantiFERON-TB Gold In-Tube assay (QFT), a test that is thought to reflect sustained M. tuberculosis infection.
The study also evaluated a candidate subunit vaccine, H4:IC31, which also reduced the rate of sustained QFT conversion, though the efficacy estimate did not reach statistical significance, investigators reported.
Neither H4:IC31 nor BCG revaccination prevented initial QFT conversion, the primary endpoint of the study; however, both vaccines were immunogenic, they said.
Moreover, the significantly reduced rate of sustained conversion with BCG revaccination provides a “promising signal,” study authors said in the New England Journal of Medicine.
“The durability of this important finding and potential public health significance for protection against tuberculosis disease warrants epidemiologic modeling and further clinical evaluation,” wrote Elisa Nemes, PhD, of the South African Tuberculosis Vaccine Initiative, which is part of the Institute of Infectious Disease and Molecular Medicine at the University of Cape Town (South Africa), and her coauthors.
Similarly, the nonsignificantly reduced rate of sustained QFT conversion seen with H4:IC31 suggested that subunit vaccines can have a biologic effect in this setting, which may inform development of new tuberculosis vaccines, Dr. Nemes and her colleagues added.
The phase 2 trial included 990 adolescents in South Africa who had undergone neonatal BCG vaccination. They were randomly assigned to receive BCG revaccination, H4:IC31 vaccine, or placebo.
Neither vaccine met the primary efficacy criterion based on initial QFT conversion rates, which were 13.1% for BCG revaccination, 14.3% for H4:IC31 vaccine, and 15.8% for placebo.
For the secondary endpoint of sustained QFT conversion, the efficacy of BCG revaccination was 45.4% (95% confidence interval, 6.4%-68.1%; P = .03), while the efficacy of H4:IC31 vaccine was 34.2% (95% CI, –10.4% to 60.7%; P = .11).
“These encouraging findings provide an impetus to reevaluate the use of BCG revaccination of populations that are free of M. tuberculosis infection for the prevention of disease,” Dr. Nemes and her coauthors wrote in their report.
Revaccination with BCG was associated with more adverse events, compared with the other groups, although adverse events in the trial were predominantly injection-site reactions that were mild to moderate in severity, investigators reported. There were no serious adverse events judged by investigators to be related to trial vaccine.
Taken together, these results raise important questions regarding the potential benefits of vaccine-mediated prevention of M. tuberculosis infection for control of tuberculosis disease, according to Dr. Nemes and her coauthors.
However, interpretation of the findings is limited because there is no definitive test for M. tuberculosis infection.
Recent infection diagnosed by tuberculin skin test or QFT conversion has been associated with higher risk of disease, compared with nonconversion, according to investigators, while reversion to a negative tuberculin skin test correlates with infection containment and lower risk of tuberculosis.
“Although the clinical significance of QFT reversion remains to be established, we propose that sustained QFT conversion more likely represents sustained M. tuberculosis infection and a higher risk of progression to disease than transient QFT conversion,” they wrote.
The study was supported by Aeras, Sanofi Pasteur, the Bill & Melinda Gates Foundation, the Government of the Netherlands Directorate-General for International Cooperation and Development, and the United Kingdom Department for International Development. Study authors reported disclosures related to GlaxoSmithKline, Sanofi Pasteur, and Aeras.
SOURCE: Nemes E et al. N Engl J Med. 2018;379:138-49.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Neither H4:IC31 nor BCG revaccination prevented initial QFT conversion, the primary endpoint; however, both vaccines were immunogenic.
Major finding: For the secondary endpoint of sustained QuantiFERON-TB Gold In-Tube Assay (QFT) conversion, efficacy was 45.4% (P = .03) for BCG revaccination and 34.2% (P = .11) for H4:IC31, a candidate subunit vaccine.
Study details: A phase 2, randomized, placebo-controlled trial including 990 adolescents in South Africa who had received BCG vaccine in infancy.
Disclosures: The study was supported by Aeras, Sanofi Pasteur, the Bill & Melinda Gates Foundation, the Government of the Netherlands Directorate-General for International Cooperation and Development, and the United Kingdom Department for International Development. Study authors reported disclosures related to GlaxoSmithKline, Sanofi Pasteur, and Aeras.
Source: Nemes E et al. N Engl J Med. 2018;379:138-49.
Early BCC seen in teen kidney transplant patient
A 17-year-old girl seen in a Portuguese dermatology clinic was found to have a nodular basal cell carcinoma on the parietal region of her scalp. The nodule appeared 6 years after she had received a kidney transplant, according to João Borges-Costa, MD, PhD, who submitted the case report.
Since the transplant, the girl had been maintained on immunosuppressive medication of tacrolimus 1 mg twice daily, mycophenolate sodium 360 mg twice daily, and prednisolone 10 mg every other day. The 1-cm nodule was pigmented; dermatoscopy did not yield clarity about whether the lesion was melanocytic. An excisional biopsy with 0.5-cm margins was performed, and histology confirmed that the lesion was a nodular pigmented basal cell carcinoma that had been excised completely.
The case, said Dr. Borges-Costa, shows that skin cancers can develop earlier than the typical 12-18 years after pediatric transplantation. Most reported cases have been squamous cell cancers and melanomas, and often are associated with lack of appropriate sun protection behavior.
The patient, a Caucasian, was a sailor who used sunscreen but did not typically wear a hat while sailing, reported Dr. Borges-Costa, a dermatologist at the University of Lisbon. Her family history was significant for a grandparent with melanoma.
Dr. Borges noted that the parents and patient were given advice regarding the importance of the lifelong use of sun-protective clothing and headgear. “Education of pediatric organ recipients and their parents about sun protection is important because, as occurred with our patient, protective clothing and hats are frequently forgotten.”
Because of the ongoing potential for skin malignancies, early referral “after transplantation to specialized dermatology outpatient clinics, similar to what is now advocated for transplanted adults, could help in surveillance and improve adherence to sun-protective measures,” he added.
SOURCE: Borges-Costa J et al. Pediatr Dermatol. 2018. doi: 10.1111/pde.13537..
A 17-year-old girl seen in a Portuguese dermatology clinic was found to have a nodular basal cell carcinoma on the parietal region of her scalp. The nodule appeared 6 years after she had received a kidney transplant, according to João Borges-Costa, MD, PhD, who submitted the case report.
Since the transplant, the girl had been maintained on immunosuppressive medication of tacrolimus 1 mg twice daily, mycophenolate sodium 360 mg twice daily, and prednisolone 10 mg every other day. The 1-cm nodule was pigmented; dermatoscopy did not yield clarity about whether the lesion was melanocytic. An excisional biopsy with 0.5-cm margins was performed, and histology confirmed that the lesion was a nodular pigmented basal cell carcinoma that had been excised completely.
The case, said Dr. Borges-Costa, shows that skin cancers can develop earlier than the typical 12-18 years after pediatric transplantation. Most reported cases have been squamous cell cancers and melanomas, and often are associated with lack of appropriate sun protection behavior.
The patient, a Caucasian, was a sailor who used sunscreen but did not typically wear a hat while sailing, reported Dr. Borges-Costa, a dermatologist at the University of Lisbon. Her family history was significant for a grandparent with melanoma.
Dr. Borges noted that the parents and patient were given advice regarding the importance of the lifelong use of sun-protective clothing and headgear. “Education of pediatric organ recipients and their parents about sun protection is important because, as occurred with our patient, protective clothing and hats are frequently forgotten.”
Because of the ongoing potential for skin malignancies, early referral “after transplantation to specialized dermatology outpatient clinics, similar to what is now advocated for transplanted adults, could help in surveillance and improve adherence to sun-protective measures,” he added.
SOURCE: Borges-Costa J et al. Pediatr Dermatol. 2018. doi: 10.1111/pde.13537..
A 17-year-old girl seen in a Portuguese dermatology clinic was found to have a nodular basal cell carcinoma on the parietal region of her scalp. The nodule appeared 6 years after she had received a kidney transplant, according to João Borges-Costa, MD, PhD, who submitted the case report.
Since the transplant, the girl had been maintained on immunosuppressive medication of tacrolimus 1 mg twice daily, mycophenolate sodium 360 mg twice daily, and prednisolone 10 mg every other day. The 1-cm nodule was pigmented; dermatoscopy did not yield clarity about whether the lesion was melanocytic. An excisional biopsy with 0.5-cm margins was performed, and histology confirmed that the lesion was a nodular pigmented basal cell carcinoma that had been excised completely.
The case, said Dr. Borges-Costa, shows that skin cancers can develop earlier than the typical 12-18 years after pediatric transplantation. Most reported cases have been squamous cell cancers and melanomas, and often are associated with lack of appropriate sun protection behavior.
The patient, a Caucasian, was a sailor who used sunscreen but did not typically wear a hat while sailing, reported Dr. Borges-Costa, a dermatologist at the University of Lisbon. Her family history was significant for a grandparent with melanoma.
Dr. Borges noted that the parents and patient were given advice regarding the importance of the lifelong use of sun-protective clothing and headgear. “Education of pediatric organ recipients and their parents about sun protection is important because, as occurred with our patient, protective clothing and hats are frequently forgotten.”
Because of the ongoing potential for skin malignancies, early referral “after transplantation to specialized dermatology outpatient clinics, similar to what is now advocated for transplanted adults, could help in surveillance and improve adherence to sun-protective measures,” he added.
SOURCE: Borges-Costa J et al. Pediatr Dermatol. 2018. doi: 10.1111/pde.13537..
FROM PEDIATRIC DERMATOLOGY
If high court reverses Roe v. Wade, 22 states poised to ban abortion
That’s the question now that President Donald Trump has chosen Judge Brett Kavanaugh as his nominee to replace retiring Supreme Court Justice Anthony Kennedy.
Reversing the landmark case would not automatically make abortion illegal across the country. Instead, it would return the decision about abortion legality to the states, where a patchwork of laws are already in place that render abortion more or less available, largely depending on individual states’ political leanings.
“We think there are 22 states likely to ban abortion without Roe,” because of a combination of factors including existing laws and regulation on the books and the positions of the governor and state legislature, said Amy Myrick, staff attorney at the Center for Reproductive Rights, which represents abortion-rights advocates in court.
“The threat level is very high now,” Ms. Myrick said.
Judge Kavanaugh never opined on Roe v. Wade directly during his tenure on the U.S. District Court in Washington. In his 2006 confirmation hearing for that position, though, he said he would follow Roe v. Wade as a “binding precedent” of the Supreme Court – which lower-court judges are required to do.
Abortion opponents are buoyed by the pick.
“Judge Kavanaugh is an experienced, principled jurist with a strong record of protecting life and constitutional rights,” Marjorie Dannenfelser, president of the Susan B. Anthony List, said in a statement. She spearheaded support for Trump in his presidential campaign after he promised to appoint to the Supreme Court only justices who would overturn Roe v. Wade.
Justice Kennedy, by contrast, was a swing vote on abortion issues. He frequently sided with conservatives to uphold abortion restrictions. However, in key cases in 1992 and 2016, he sided with liberals to uphold Roe’s core finding that the right to abortion is part of a right to privacy that is embedded within the U.S. Constitution.
Even now, with Roe v. Wade’s protections in place, a woman’s ability to access abortion is heavily dependent on where she lives.
According to an analysis by the Guttmacher Institute, a reproductive-rights think tank, 19 states adopted 63 new restrictions on abortion rights and access. At the same time, 21 states adopted 58 measures last year intended to expand access to women’s reproductive health.
Since 2011, states have enacted nearly 1,200 separate abortion restrictions, according to Guttmacher, making these types of laws far more common.
As of now, four states – Louisiana, Mississippi and North and South Dakota – have what are known as abortion “trigger laws.” Those laws – passed long after Roe was handed down – would make abortion illegal if and when the Supreme Court were to say Roe is no more.
“They are designed to make abortion illegal immediately,” said Ms. Myrick.
Another dozen or so states still have abortion bans on the books that predated Roe v. Wade.
Some have been formally blocked by the courts but not repealed. Those bans could, at least in theory, be reinstated, although “someone would have to go into court and ask to lift that injunction,” said Ms. Myrick.
States could simply begin enforcing other bans that were never formally blocked, like one in Alabama that makes abortion providers subject to fines and up to a year in jail.
At the same time, Ms. Myrick said, “there are 20 states where abortion would probably remain safe and legal.”
The path to the high court
Several major challenges to state abortion laws are already in the judicial pipeline. One of these will have to get to the Supreme Court to enable a majority to overturn Roe v. Wade.
“It’s not a question of if, it’s a question of what or when,” said Sarah Lipton-Lubet, vice president for reproductive health and rights at the National Partnership for Women & Families.
The cases fall into three major categories.
The first – and most likely type to result in the court taking a broad look at Roe v. Wade – are “gestational” bans that seek to restrict abortion at a certain point in pregnancy, said Ms. Lipton-Lubet.
Mississippi has a 15-week ban, currently being challenged in federal court; Louisiana enacted a similar ban, but it would take effect only if Mississippi’s law is upheld. Iowa earlier this spring passed a 6-week ban, although that is being challenged in state court under the Iowa Constitution.
The second category involves regulations on abortion providers.
One pending case, for instance, involves an Arkansas law that would effectively ban medication abortions. Finally, there are bans on specific procedures, including several in Texas, Arkansas, and Alabama that would outlaw “dilation and evacuation” abortions, which are the most common type used in the second trimester of pregnancy.
Ms. Myrick and Ms. Lipton-Lubet agree that there is no way to predict which abortion case is likely to reach the high court first.
The case that’s actually closest to the Supreme Court, noted Ms. Myrick, is a challenge to an Indiana law that would outlaw abortion if the woman is seeking it for sex selection or because the fetus could be disabled. A federal appeals court found that law unconstitutional in April.
Many analysts also agree that even with the court’s likely philosophical shift, Roe v. Wade might not actually be overturned at all.
Instead, said Ms. Lipton-Lubet, a more conservative court could “just hollow it out” by allowing restrictive state laws to stand.
“The court cares about things like its own legitimacy,” said Ms. Myrick, “and how often a precedent has been upheld in the past.”
Given that Roe’s central finding – that the decision to have an abortion falls under the constitutional right to privacy – has been upheld three times, even an antiabortion court might be loath to overrule it in its entirety.
KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
That’s the question now that President Donald Trump has chosen Judge Brett Kavanaugh as his nominee to replace retiring Supreme Court Justice Anthony Kennedy.
Reversing the landmark case would not automatically make abortion illegal across the country. Instead, it would return the decision about abortion legality to the states, where a patchwork of laws are already in place that render abortion more or less available, largely depending on individual states’ political leanings.
“We think there are 22 states likely to ban abortion without Roe,” because of a combination of factors including existing laws and regulation on the books and the positions of the governor and state legislature, said Amy Myrick, staff attorney at the Center for Reproductive Rights, which represents abortion-rights advocates in court.
“The threat level is very high now,” Ms. Myrick said.
Judge Kavanaugh never opined on Roe v. Wade directly during his tenure on the U.S. District Court in Washington. In his 2006 confirmation hearing for that position, though, he said he would follow Roe v. Wade as a “binding precedent” of the Supreme Court – which lower-court judges are required to do.
Abortion opponents are buoyed by the pick.
“Judge Kavanaugh is an experienced, principled jurist with a strong record of protecting life and constitutional rights,” Marjorie Dannenfelser, president of the Susan B. Anthony List, said in a statement. She spearheaded support for Trump in his presidential campaign after he promised to appoint to the Supreme Court only justices who would overturn Roe v. Wade.
Justice Kennedy, by contrast, was a swing vote on abortion issues. He frequently sided with conservatives to uphold abortion restrictions. However, in key cases in 1992 and 2016, he sided with liberals to uphold Roe’s core finding that the right to abortion is part of a right to privacy that is embedded within the U.S. Constitution.
Even now, with Roe v. Wade’s protections in place, a woman’s ability to access abortion is heavily dependent on where she lives.
According to an analysis by the Guttmacher Institute, a reproductive-rights think tank, 19 states adopted 63 new restrictions on abortion rights and access. At the same time, 21 states adopted 58 measures last year intended to expand access to women’s reproductive health.
Since 2011, states have enacted nearly 1,200 separate abortion restrictions, according to Guttmacher, making these types of laws far more common.
As of now, four states – Louisiana, Mississippi and North and South Dakota – have what are known as abortion “trigger laws.” Those laws – passed long after Roe was handed down – would make abortion illegal if and when the Supreme Court were to say Roe is no more.
“They are designed to make abortion illegal immediately,” said Ms. Myrick.
Another dozen or so states still have abortion bans on the books that predated Roe v. Wade.
Some have been formally blocked by the courts but not repealed. Those bans could, at least in theory, be reinstated, although “someone would have to go into court and ask to lift that injunction,” said Ms. Myrick.
States could simply begin enforcing other bans that were never formally blocked, like one in Alabama that makes abortion providers subject to fines and up to a year in jail.
At the same time, Ms. Myrick said, “there are 20 states where abortion would probably remain safe and legal.”
The path to the high court
Several major challenges to state abortion laws are already in the judicial pipeline. One of these will have to get to the Supreme Court to enable a majority to overturn Roe v. Wade.
“It’s not a question of if, it’s a question of what or when,” said Sarah Lipton-Lubet, vice president for reproductive health and rights at the National Partnership for Women & Families.
The cases fall into three major categories.
The first – and most likely type to result in the court taking a broad look at Roe v. Wade – are “gestational” bans that seek to restrict abortion at a certain point in pregnancy, said Ms. Lipton-Lubet.
Mississippi has a 15-week ban, currently being challenged in federal court; Louisiana enacted a similar ban, but it would take effect only if Mississippi’s law is upheld. Iowa earlier this spring passed a 6-week ban, although that is being challenged in state court under the Iowa Constitution.
The second category involves regulations on abortion providers.
One pending case, for instance, involves an Arkansas law that would effectively ban medication abortions. Finally, there are bans on specific procedures, including several in Texas, Arkansas, and Alabama that would outlaw “dilation and evacuation” abortions, which are the most common type used in the second trimester of pregnancy.
Ms. Myrick and Ms. Lipton-Lubet agree that there is no way to predict which abortion case is likely to reach the high court first.
The case that’s actually closest to the Supreme Court, noted Ms. Myrick, is a challenge to an Indiana law that would outlaw abortion if the woman is seeking it for sex selection or because the fetus could be disabled. A federal appeals court found that law unconstitutional in April.
Many analysts also agree that even with the court’s likely philosophical shift, Roe v. Wade might not actually be overturned at all.
Instead, said Ms. Lipton-Lubet, a more conservative court could “just hollow it out” by allowing restrictive state laws to stand.
“The court cares about things like its own legitimacy,” said Ms. Myrick, “and how often a precedent has been upheld in the past.”
Given that Roe’s central finding – that the decision to have an abortion falls under the constitutional right to privacy – has been upheld three times, even an antiabortion court might be loath to overrule it in its entirety.
KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
That’s the question now that President Donald Trump has chosen Judge Brett Kavanaugh as his nominee to replace retiring Supreme Court Justice Anthony Kennedy.
Reversing the landmark case would not automatically make abortion illegal across the country. Instead, it would return the decision about abortion legality to the states, where a patchwork of laws are already in place that render abortion more or less available, largely depending on individual states’ political leanings.
“We think there are 22 states likely to ban abortion without Roe,” because of a combination of factors including existing laws and regulation on the books and the positions of the governor and state legislature, said Amy Myrick, staff attorney at the Center for Reproductive Rights, which represents abortion-rights advocates in court.
“The threat level is very high now,” Ms. Myrick said.
Judge Kavanaugh never opined on Roe v. Wade directly during his tenure on the U.S. District Court in Washington. In his 2006 confirmation hearing for that position, though, he said he would follow Roe v. Wade as a “binding precedent” of the Supreme Court – which lower-court judges are required to do.
Abortion opponents are buoyed by the pick.
“Judge Kavanaugh is an experienced, principled jurist with a strong record of protecting life and constitutional rights,” Marjorie Dannenfelser, president of the Susan B. Anthony List, said in a statement. She spearheaded support for Trump in his presidential campaign after he promised to appoint to the Supreme Court only justices who would overturn Roe v. Wade.
Justice Kennedy, by contrast, was a swing vote on abortion issues. He frequently sided with conservatives to uphold abortion restrictions. However, in key cases in 1992 and 2016, he sided with liberals to uphold Roe’s core finding that the right to abortion is part of a right to privacy that is embedded within the U.S. Constitution.
Even now, with Roe v. Wade’s protections in place, a woman’s ability to access abortion is heavily dependent on where she lives.
According to an analysis by the Guttmacher Institute, a reproductive-rights think tank, 19 states adopted 63 new restrictions on abortion rights and access. At the same time, 21 states adopted 58 measures last year intended to expand access to women’s reproductive health.
Since 2011, states have enacted nearly 1,200 separate abortion restrictions, according to Guttmacher, making these types of laws far more common.
As of now, four states – Louisiana, Mississippi and North and South Dakota – have what are known as abortion “trigger laws.” Those laws – passed long after Roe was handed down – would make abortion illegal if and when the Supreme Court were to say Roe is no more.
“They are designed to make abortion illegal immediately,” said Ms. Myrick.
Another dozen or so states still have abortion bans on the books that predated Roe v. Wade.
Some have been formally blocked by the courts but not repealed. Those bans could, at least in theory, be reinstated, although “someone would have to go into court and ask to lift that injunction,” said Ms. Myrick.
States could simply begin enforcing other bans that were never formally blocked, like one in Alabama that makes abortion providers subject to fines and up to a year in jail.
At the same time, Ms. Myrick said, “there are 20 states where abortion would probably remain safe and legal.”
The path to the high court
Several major challenges to state abortion laws are already in the judicial pipeline. One of these will have to get to the Supreme Court to enable a majority to overturn Roe v. Wade.
“It’s not a question of if, it’s a question of what or when,” said Sarah Lipton-Lubet, vice president for reproductive health and rights at the National Partnership for Women & Families.
The cases fall into three major categories.
The first – and most likely type to result in the court taking a broad look at Roe v. Wade – are “gestational” bans that seek to restrict abortion at a certain point in pregnancy, said Ms. Lipton-Lubet.
Mississippi has a 15-week ban, currently being challenged in federal court; Louisiana enacted a similar ban, but it would take effect only if Mississippi’s law is upheld. Iowa earlier this spring passed a 6-week ban, although that is being challenged in state court under the Iowa Constitution.
The second category involves regulations on abortion providers.
One pending case, for instance, involves an Arkansas law that would effectively ban medication abortions. Finally, there are bans on specific procedures, including several in Texas, Arkansas, and Alabama that would outlaw “dilation and evacuation” abortions, which are the most common type used in the second trimester of pregnancy.
Ms. Myrick and Ms. Lipton-Lubet agree that there is no way to predict which abortion case is likely to reach the high court first.
The case that’s actually closest to the Supreme Court, noted Ms. Myrick, is a challenge to an Indiana law that would outlaw abortion if the woman is seeking it for sex selection or because the fetus could be disabled. A federal appeals court found that law unconstitutional in April.
Many analysts also agree that even with the court’s likely philosophical shift, Roe v. Wade might not actually be overturned at all.
Instead, said Ms. Lipton-Lubet, a more conservative court could “just hollow it out” by allowing restrictive state laws to stand.
“The court cares about things like its own legitimacy,” said Ms. Myrick, “and how often a precedent has been upheld in the past.”
Given that Roe’s central finding – that the decision to have an abortion falls under the constitutional right to privacy – has been upheld three times, even an antiabortion court might be loath to overrule it in its entirety.
KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Stigma of Epilepsy Burdens Caregivers
Family caregivers of patients with intractable epilepsy are subject to significant stigma because of societal views about the disorder, according to cross-sectional analysis recently published in Epilepsy and Behavior.
- Self-administered surveys were taken by caregivers of adults and children with a confirmed diagnosis of intractable epilepsy.
- Affiliate stigma was defined as perceiving and internalizing negative societal views of the disorder and having a psychological response to those views.
- Caregivers’ psychological burdens were measured using the 30-item Carer’s Assessment of Difficulties Index and the stigma was evaluated with a separate 6-item scale that measured their perceptions of stigma.
- The 136 respondents were mostly white, female, and married.
- Investigators found the link between the stigma of epilepsy and the burden caregivers experienced was stronger among family members caring for adult patients.
Hansena B, Szaflarski M, Bebin EB, Szaflarski JP. Affiliate stigma and caregiver burden in intractable epilepsy. Epilepsy Behav. 2018;85:1-6.
Family caregivers of patients with intractable epilepsy are subject to significant stigma because of societal views about the disorder, according to cross-sectional analysis recently published in Epilepsy and Behavior.
- Self-administered surveys were taken by caregivers of adults and children with a confirmed diagnosis of intractable epilepsy.
- Affiliate stigma was defined as perceiving and internalizing negative societal views of the disorder and having a psychological response to those views.
- Caregivers’ psychological burdens were measured using the 30-item Carer’s Assessment of Difficulties Index and the stigma was evaluated with a separate 6-item scale that measured their perceptions of stigma.
- The 136 respondents were mostly white, female, and married.
- Investigators found the link between the stigma of epilepsy and the burden caregivers experienced was stronger among family members caring for adult patients.
Hansena B, Szaflarski M, Bebin EB, Szaflarski JP. Affiliate stigma and caregiver burden in intractable epilepsy. Epilepsy Behav. 2018;85:1-6.
Family caregivers of patients with intractable epilepsy are subject to significant stigma because of societal views about the disorder, according to cross-sectional analysis recently published in Epilepsy and Behavior.
- Self-administered surveys were taken by caregivers of adults and children with a confirmed diagnosis of intractable epilepsy.
- Affiliate stigma was defined as perceiving and internalizing negative societal views of the disorder and having a psychological response to those views.
- Caregivers’ psychological burdens were measured using the 30-item Carer’s Assessment of Difficulties Index and the stigma was evaluated with a separate 6-item scale that measured their perceptions of stigma.
- The 136 respondents were mostly white, female, and married.
- Investigators found the link between the stigma of epilepsy and the burden caregivers experienced was stronger among family members caring for adult patients.
Hansena B, Szaflarski M, Bebin EB, Szaflarski JP. Affiliate stigma and caregiver burden in intractable epilepsy. Epilepsy Behav. 2018;85:1-6.
Study Suggests Improvement Needed in AED Treatment
About 50% of patients with epilepsy remained untreated for 6 months after their initial diagnosis according to a retrospective analysis of more than 58,000 cases.
- At 6 months after diagnosis, 46.8% were receiving treatment with antiepilepsy medication; at 12 months, that statistic had only climbed to 52.2%.
- Among the 29,226 patients who were receiving medication, nearly three quarters received monotherapy and 1.6% polytherapy as first treatment for 90 days or longer.
- The likelihood of patients remaining on antiepilepsy medication after a year was 61% for those on a single agent and 36.5% for those on more than one drug.
Faught E, Helmers S, Thurman D, et al. Patient characteristics and treatment patterns in patients with newly diagnosed epilepsy: A US database analysis. Epilepsy Behav. 2018;85:37-44.
About 50% of patients with epilepsy remained untreated for 6 months after their initial diagnosis according to a retrospective analysis of more than 58,000 cases.
- At 6 months after diagnosis, 46.8% were receiving treatment with antiepilepsy medication; at 12 months, that statistic had only climbed to 52.2%.
- Among the 29,226 patients who were receiving medication, nearly three quarters received monotherapy and 1.6% polytherapy as first treatment for 90 days or longer.
- The likelihood of patients remaining on antiepilepsy medication after a year was 61% for those on a single agent and 36.5% for those on more than one drug.
Faught E, Helmers S, Thurman D, et al. Patient characteristics and treatment patterns in patients with newly diagnosed epilepsy: A US database analysis. Epilepsy Behav. 2018;85:37-44.
About 50% of patients with epilepsy remained untreated for 6 months after their initial diagnosis according to a retrospective analysis of more than 58,000 cases.
- At 6 months after diagnosis, 46.8% were receiving treatment with antiepilepsy medication; at 12 months, that statistic had only climbed to 52.2%.
- Among the 29,226 patients who were receiving medication, nearly three quarters received monotherapy and 1.6% polytherapy as first treatment for 90 days or longer.
- The likelihood of patients remaining on antiepilepsy medication after a year was 61% for those on a single agent and 36.5% for those on more than one drug.
Faught E, Helmers S, Thurman D, et al. Patient characteristics and treatment patterns in patients with newly diagnosed epilepsy: A US database analysis. Epilepsy Behav. 2018;85:37-44.
Anxiety Plagues Many Patients with Epilepsy
Nearly half of patients with epilepsy have symptoms of high anxiety according to a study of adults treated in tertiary care centers.
- The study, which included 540 patients, evaluated the presence of anxiety with the Symptoms Checklist 90-R anxiety subscale. It also evaluated patients for depression with separate scales.
- 250 patients (46.1%) reported high anxiety.
- Focal epilepsy and epilepsy of unknown type, as well as depression scores, were independently linked to high anxiety.
- In patients with focal epilepsy, mesial temporal sclerosis was independently associated with high anxiety.
- Other factors linked to high anxiety included lower education level, being non-white, having Spanish as a native language, prior head trauma, and polydrug therapy for epilepsy.
- The researchers suggest that screening for anxiety in an epilepsy clinic can help spot patients in need of treatment.
Munger Clary HM, Snively BM, Hamberger MJ. Anxiety is common and independently associated with clinical features of epilepsy. Epilepsy Behav. 2018;85:64-71.
Nearly half of patients with epilepsy have symptoms of high anxiety according to a study of adults treated in tertiary care centers.
- The study, which included 540 patients, evaluated the presence of anxiety with the Symptoms Checklist 90-R anxiety subscale. It also evaluated patients for depression with separate scales.
- 250 patients (46.1%) reported high anxiety.
- Focal epilepsy and epilepsy of unknown type, as well as depression scores, were independently linked to high anxiety.
- In patients with focal epilepsy, mesial temporal sclerosis was independently associated with high anxiety.
- Other factors linked to high anxiety included lower education level, being non-white, having Spanish as a native language, prior head trauma, and polydrug therapy for epilepsy.
- The researchers suggest that screening for anxiety in an epilepsy clinic can help spot patients in need of treatment.
Munger Clary HM, Snively BM, Hamberger MJ. Anxiety is common and independently associated with clinical features of epilepsy. Epilepsy Behav. 2018;85:64-71.
Nearly half of patients with epilepsy have symptoms of high anxiety according to a study of adults treated in tertiary care centers.
- The study, which included 540 patients, evaluated the presence of anxiety with the Symptoms Checklist 90-R anxiety subscale. It also evaluated patients for depression with separate scales.
- 250 patients (46.1%) reported high anxiety.
- Focal epilepsy and epilepsy of unknown type, as well as depression scores, were independently linked to high anxiety.
- In patients with focal epilepsy, mesial temporal sclerosis was independently associated with high anxiety.
- Other factors linked to high anxiety included lower education level, being non-white, having Spanish as a native language, prior head trauma, and polydrug therapy for epilepsy.
- The researchers suggest that screening for anxiety in an epilepsy clinic can help spot patients in need of treatment.
Munger Clary HM, Snively BM, Hamberger MJ. Anxiety is common and independently associated with clinical features of epilepsy. Epilepsy Behav. 2018;85:64-71.