Corpus callosum functioning, structural integrity impaired in some TBI patients

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Corpus callosum functioning, structural integrity impaired in some TBI patients

Half of moderate to severe traumatic brain injury patients had markedly impaired corpus callosum (CC) functioning and structural integrity that is associated with poor neurocognitive functioning, according to a study of children aged 8-19 years.

The researchers used high angular resolution diffusion-weighted imaging to determine the structural integrities of the CC in 32 children who had suffered a traumatic brain injury (TBI) and of the CC in 31 healthy children. Patients in the experimental group had suffered from a moderate to severe TBI 1-5 months prior to the study. The researchers assessed CC function through interhemispheric transfer time (IHTT) – the time required to transfer stimulus-locked neural activity between the left and right brain hemispheres. Each participant’s IHTT was calculated from recording electroencephalography, while he or she completed a computerized, pattern-matching task with bilateral field advantage.

Half of the TBI patients had significantly slower IHTTs than did the control group. The IHTTs of this so-called IHTT-slow TBI group deviated by at least 1.5 standard deviations from data for the healthy control group.

The IHTT-slow TBI group also demonstrated lower CC integrity and poorer neurocognitive functioning than did both the control group and the remaining members of the experimental group. Lower fractional anisotropy (FA) – a common sign of impaired white matter (WM) – and slower IHTTs also predicted poor neurocognitive function.

“When we compared the IHTT-slow TBI group to the healthy control group, we found significant differences in callosal WM integrity, as well as the integrity of the association and projection tract systems tested. Lower FA and higher mean diffusivity (MD) in the IHTT-slow group suggests myelin disruption,” noted Emily L Dennis of the University of Southern California, Marina del Rey, and her colleagues. “When we compared the IHTT-normal TBI group to the healthy control group, we found only a few areas where the TBI group had significantly lower FA and no significant differences in MD [mean diffusivity].”

Read the full study in the Journal of Neuroscience (doi:10.1523/JNEUROSCI.1595-15.2015).

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Half of moderate to severe traumatic brain injury patients had markedly impaired corpus callosum (CC) functioning and structural integrity that is associated with poor neurocognitive functioning, according to a study of children aged 8-19 years.

The researchers used high angular resolution diffusion-weighted imaging to determine the structural integrities of the CC in 32 children who had suffered a traumatic brain injury (TBI) and of the CC in 31 healthy children. Patients in the experimental group had suffered from a moderate to severe TBI 1-5 months prior to the study. The researchers assessed CC function through interhemispheric transfer time (IHTT) – the time required to transfer stimulus-locked neural activity between the left and right brain hemispheres. Each participant’s IHTT was calculated from recording electroencephalography, while he or she completed a computerized, pattern-matching task with bilateral field advantage.

Half of the TBI patients had significantly slower IHTTs than did the control group. The IHTTs of this so-called IHTT-slow TBI group deviated by at least 1.5 standard deviations from data for the healthy control group.

The IHTT-slow TBI group also demonstrated lower CC integrity and poorer neurocognitive functioning than did both the control group and the remaining members of the experimental group. Lower fractional anisotropy (FA) – a common sign of impaired white matter (WM) – and slower IHTTs also predicted poor neurocognitive function.

“When we compared the IHTT-slow TBI group to the healthy control group, we found significant differences in callosal WM integrity, as well as the integrity of the association and projection tract systems tested. Lower FA and higher mean diffusivity (MD) in the IHTT-slow group suggests myelin disruption,” noted Emily L Dennis of the University of Southern California, Marina del Rey, and her colleagues. “When we compared the IHTT-normal TBI group to the healthy control group, we found only a few areas where the TBI group had significantly lower FA and no significant differences in MD [mean diffusivity].”

Read the full study in the Journal of Neuroscience (doi:10.1523/JNEUROSCI.1595-15.2015).

[email protected]

Half of moderate to severe traumatic brain injury patients had markedly impaired corpus callosum (CC) functioning and structural integrity that is associated with poor neurocognitive functioning, according to a study of children aged 8-19 years.

The researchers used high angular resolution diffusion-weighted imaging to determine the structural integrities of the CC in 32 children who had suffered a traumatic brain injury (TBI) and of the CC in 31 healthy children. Patients in the experimental group had suffered from a moderate to severe TBI 1-5 months prior to the study. The researchers assessed CC function through interhemispheric transfer time (IHTT) – the time required to transfer stimulus-locked neural activity between the left and right brain hemispheres. Each participant’s IHTT was calculated from recording electroencephalography, while he or she completed a computerized, pattern-matching task with bilateral field advantage.

Half of the TBI patients had significantly slower IHTTs than did the control group. The IHTTs of this so-called IHTT-slow TBI group deviated by at least 1.5 standard deviations from data for the healthy control group.

The IHTT-slow TBI group also demonstrated lower CC integrity and poorer neurocognitive functioning than did both the control group and the remaining members of the experimental group. Lower fractional anisotropy (FA) – a common sign of impaired white matter (WM) – and slower IHTTs also predicted poor neurocognitive function.

“When we compared the IHTT-slow TBI group to the healthy control group, we found significant differences in callosal WM integrity, as well as the integrity of the association and projection tract systems tested. Lower FA and higher mean diffusivity (MD) in the IHTT-slow group suggests myelin disruption,” noted Emily L Dennis of the University of Southern California, Marina del Rey, and her colleagues. “When we compared the IHTT-normal TBI group to the healthy control group, we found only a few areas where the TBI group had significantly lower FA and no significant differences in MD [mean diffusivity].”

Read the full study in the Journal of Neuroscience (doi:10.1523/JNEUROSCI.1595-15.2015).

[email protected]

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Patients’ web portals to access EHRs need improvement

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Patients’ web portals to access EHRs need improvement

Owners and creators of patient-facing web portals to access individuals’ electronic health records (EHRs) need to improve the portals’ usability, according to researchers from the University of California San Francisco.

The essay is a response to the efficacy of the federal Meaningful Use program, a multibillion-dollar EHR incentive program managed by the Office of the National Coordinator for Health Information Technology.

So far, the federal government has awarded more than $25 billion to health care clinics and hospitals to “incentivize [them] to implement electronic health records across the United States,” Courtney Lyles, Ph.D., and her colleagues said in a statement. The program covers a number of targets, including patient registration and use of portal websites that are linked to patients’ electronic health records.

The authors acknowledged the program’s success at awarding payments for EHR implementation; 94% of U.S. hospitals and 77% of U.S. office-based health professionals have received implementation payments. But the authors complained that “the lack of usability [of the web portals] is a formidable barrier to achieving widespread use of portals and other patient-facing technology, particularity for diverse groups.”

A study of a racially and ethnically diverse group of 51 older adults, which the authors cited in the essay, suggests that their criticism of the portals is warranted.

According to the study, only 12% of participants who said they would use a portal website after being shown a video were able to correctly complete a set of simple tasks – and none was able to complete a set of complex tasks with the portal (J. Appl. Gerontol. 2014;33:416-36).

The essay’s authors also expressed concern about the challenges faced specifically by non-English speakers and those with limited literacy.

Health care providers and hospital systems should “look to purchase EHRs with patient-facing portal products that meet the basic needs of their population,” the authors suggested. For example, such products should be accessible in the languages best understood by health systems’ patients. The authors also urged EHR/portal programmers and developers to “familiarize themselves with the issues of health literacy and health care disparities.”

Read the full essay in PLoS Medicine (July 14, 2015 [doi:10.1371/journal.pmed.1001852]).

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Owners and creators of patient-facing web portals to access individuals’ electronic health records (EHRs) need to improve the portals’ usability, according to researchers from the University of California San Francisco.

The essay is a response to the efficacy of the federal Meaningful Use program, a multibillion-dollar EHR incentive program managed by the Office of the National Coordinator for Health Information Technology.

So far, the federal government has awarded more than $25 billion to health care clinics and hospitals to “incentivize [them] to implement electronic health records across the United States,” Courtney Lyles, Ph.D., and her colleagues said in a statement. The program covers a number of targets, including patient registration and use of portal websites that are linked to patients’ electronic health records.

The authors acknowledged the program’s success at awarding payments for EHR implementation; 94% of U.S. hospitals and 77% of U.S. office-based health professionals have received implementation payments. But the authors complained that “the lack of usability [of the web portals] is a formidable barrier to achieving widespread use of portals and other patient-facing technology, particularity for diverse groups.”

A study of a racially and ethnically diverse group of 51 older adults, which the authors cited in the essay, suggests that their criticism of the portals is warranted.

According to the study, only 12% of participants who said they would use a portal website after being shown a video were able to correctly complete a set of simple tasks – and none was able to complete a set of complex tasks with the portal (J. Appl. Gerontol. 2014;33:416-36).

The essay’s authors also expressed concern about the challenges faced specifically by non-English speakers and those with limited literacy.

Health care providers and hospital systems should “look to purchase EHRs with patient-facing portal products that meet the basic needs of their population,” the authors suggested. For example, such products should be accessible in the languages best understood by health systems’ patients. The authors also urged EHR/portal programmers and developers to “familiarize themselves with the issues of health literacy and health care disparities.”

Read the full essay in PLoS Medicine (July 14, 2015 [doi:10.1371/journal.pmed.1001852]).

[email protected]

Owners and creators of patient-facing web portals to access individuals’ electronic health records (EHRs) need to improve the portals’ usability, according to researchers from the University of California San Francisco.

The essay is a response to the efficacy of the federal Meaningful Use program, a multibillion-dollar EHR incentive program managed by the Office of the National Coordinator for Health Information Technology.

So far, the federal government has awarded more than $25 billion to health care clinics and hospitals to “incentivize [them] to implement electronic health records across the United States,” Courtney Lyles, Ph.D., and her colleagues said in a statement. The program covers a number of targets, including patient registration and use of portal websites that are linked to patients’ electronic health records.

The authors acknowledged the program’s success at awarding payments for EHR implementation; 94% of U.S. hospitals and 77% of U.S. office-based health professionals have received implementation payments. But the authors complained that “the lack of usability [of the web portals] is a formidable barrier to achieving widespread use of portals and other patient-facing technology, particularity for diverse groups.”

A study of a racially and ethnically diverse group of 51 older adults, which the authors cited in the essay, suggests that their criticism of the portals is warranted.

According to the study, only 12% of participants who said they would use a portal website after being shown a video were able to correctly complete a set of simple tasks – and none was able to complete a set of complex tasks with the portal (J. Appl. Gerontol. 2014;33:416-36).

The essay’s authors also expressed concern about the challenges faced specifically by non-English speakers and those with limited literacy.

Health care providers and hospital systems should “look to purchase EHRs with patient-facing portal products that meet the basic needs of their population,” the authors suggested. For example, such products should be accessible in the languages best understood by health systems’ patients. The authors also urged EHR/portal programmers and developers to “familiarize themselves with the issues of health literacy and health care disparities.”

Read the full essay in PLoS Medicine (July 14, 2015 [doi:10.1371/journal.pmed.1001852]).

[email protected]

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Higher cardiorespiratory fitness linked with less depression in middle schoolers

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Higher cardiorespiratory fitness linked with less depression in middle schoolers

Improving cardiorespiratory fitness may help prevent depression in adolescents, according to a study of 197 male and 240 female middle schoolers in Texas.

The study participants’ weight, height, physical fitness, and psychological well-being were assessed twice, once during sixth grade and once during seventh grade.

The sixth grade assessments showed strong cross-sectional associations between cardiorespiratory fitness (CRF) and less depression for both the male and female groups.

Examining the data for the girls alone showed more evidence of higher CRF being negatively correlated with depression, in that the girls’ sixth grade CRF was determined to be “a significant predictor of lower depression in seventh grade,” after sixth grade body composition and depression were controlled for. Data for the boys showed this trend as well, but this finding was not statistically significant.

A significant finding from studying the male subset was that sixth grade depression was a predictor of poorer CRF in seventh grade.

“Preexisting levels of depression (i.e., in sixth grade) were the most powerful predictor of subsequent depression. However, even after controlling for sixth grade depression and body composition, higher levels of CRF in sixth grade were associated with significantly less depression by the seventh grade for girls,” according to Camilo J. Ruggero, Ph.D., of the University of North Texas, Denton, and his colleagues.

“Moving forward, stakeholders and researchers concerned about depression during middle school would benefit from regular assessment of not simply physical activity, but levels of CRF as well,” noted the researchers.

Read the full study in the Journal of Adolescent Health.

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Improving cardiorespiratory fitness may help prevent depression in adolescents, according to a study of 197 male and 240 female middle schoolers in Texas.

The study participants’ weight, height, physical fitness, and psychological well-being were assessed twice, once during sixth grade and once during seventh grade.

The sixth grade assessments showed strong cross-sectional associations between cardiorespiratory fitness (CRF) and less depression for both the male and female groups.

Examining the data for the girls alone showed more evidence of higher CRF being negatively correlated with depression, in that the girls’ sixth grade CRF was determined to be “a significant predictor of lower depression in seventh grade,” after sixth grade body composition and depression were controlled for. Data for the boys showed this trend as well, but this finding was not statistically significant.

A significant finding from studying the male subset was that sixth grade depression was a predictor of poorer CRF in seventh grade.

“Preexisting levels of depression (i.e., in sixth grade) were the most powerful predictor of subsequent depression. However, even after controlling for sixth grade depression and body composition, higher levels of CRF in sixth grade were associated with significantly less depression by the seventh grade for girls,” according to Camilo J. Ruggero, Ph.D., of the University of North Texas, Denton, and his colleagues.

“Moving forward, stakeholders and researchers concerned about depression during middle school would benefit from regular assessment of not simply physical activity, but levels of CRF as well,” noted the researchers.

Read the full study in the Journal of Adolescent Health.

[email protected]

Improving cardiorespiratory fitness may help prevent depression in adolescents, according to a study of 197 male and 240 female middle schoolers in Texas.

The study participants’ weight, height, physical fitness, and psychological well-being were assessed twice, once during sixth grade and once during seventh grade.

The sixth grade assessments showed strong cross-sectional associations between cardiorespiratory fitness (CRF) and less depression for both the male and female groups.

Examining the data for the girls alone showed more evidence of higher CRF being negatively correlated with depression, in that the girls’ sixth grade CRF was determined to be “a significant predictor of lower depression in seventh grade,” after sixth grade body composition and depression were controlled for. Data for the boys showed this trend as well, but this finding was not statistically significant.

A significant finding from studying the male subset was that sixth grade depression was a predictor of poorer CRF in seventh grade.

“Preexisting levels of depression (i.e., in sixth grade) were the most powerful predictor of subsequent depression. However, even after controlling for sixth grade depression and body composition, higher levels of CRF in sixth grade were associated with significantly less depression by the seventh grade for girls,” according to Camilo J. Ruggero, Ph.D., of the University of North Texas, Denton, and his colleagues.

“Moving forward, stakeholders and researchers concerned about depression during middle school would benefit from regular assessment of not simply physical activity, but levels of CRF as well,” noted the researchers.

Read the full study in the Journal of Adolescent Health.

[email protected]

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RAI given to thyroid CA patients does not increase their breast malignancy occurrence, recurrence

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Radioactive iodine (RAI) therapy in thyroid cancer patients does not cause such patients to get breast cancer, suggests a retrospective study of female patients from Seoul National University Hospital in South Korea.

The study enrolled 6,150 patients with thyroid cancer between 1973 and 2009, who were followed until December 2012. Of the sample, 3.691 (59%) received RAI therapy, and 99 were diagnosed with primary breast cancers during the follow-up period.

The study showed that RAI therapy did not significantly increase the incidence of breast cancer subsequent to diagnosis of thyroid cancer among patients, when a 2-year latency period was accounted for. An additional finding was that the numbers of breast cancer diagnoses made during the follow-up period for those study participants who received high doses of RAI therapy (greater than or equal to 120 mCi) and those patients who did not receive any RAI therapy were not significantly different from each other.

“The results from our study based on a large cohort of thyroid cancer patients clearly demonstrated that RAI treatment in these patients did not increase the risk of development nor worsen the recurrence of breast cancer,” Dr. Hwa Young Ahn of the department of internal medicine at Seoul National University, South Korea, and Hye Sook Min, and associates.

Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2014-2896).

This study was supported by research grants from the Korean Foundation for Cancer Research, Seoul National University Bundang Hospital Research Grants, and the Education and Research Encouragement Fund of Seoul National University Hospital. The investigators reported having no financial conflicts of interest.

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Radioactive iodine (RAI) therapy in thyroid cancer patients does not cause such patients to get breast cancer, suggests a retrospective study of female patients from Seoul National University Hospital in South Korea.

The study enrolled 6,150 patients with thyroid cancer between 1973 and 2009, who were followed until December 2012. Of the sample, 3.691 (59%) received RAI therapy, and 99 were diagnosed with primary breast cancers during the follow-up period.

The study showed that RAI therapy did not significantly increase the incidence of breast cancer subsequent to diagnosis of thyroid cancer among patients, when a 2-year latency period was accounted for. An additional finding was that the numbers of breast cancer diagnoses made during the follow-up period for those study participants who received high doses of RAI therapy (greater than or equal to 120 mCi) and those patients who did not receive any RAI therapy were not significantly different from each other.

“The results from our study based on a large cohort of thyroid cancer patients clearly demonstrated that RAI treatment in these patients did not increase the risk of development nor worsen the recurrence of breast cancer,” Dr. Hwa Young Ahn of the department of internal medicine at Seoul National University, South Korea, and Hye Sook Min, and associates.

Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2014-2896).

This study was supported by research grants from the Korean Foundation for Cancer Research, Seoul National University Bundang Hospital Research Grants, and the Education and Research Encouragement Fund of Seoul National University Hospital. The investigators reported having no financial conflicts of interest.

[email protected]

Radioactive iodine (RAI) therapy in thyroid cancer patients does not cause such patients to get breast cancer, suggests a retrospective study of female patients from Seoul National University Hospital in South Korea.

The study enrolled 6,150 patients with thyroid cancer between 1973 and 2009, who were followed until December 2012. Of the sample, 3.691 (59%) received RAI therapy, and 99 were diagnosed with primary breast cancers during the follow-up period.

The study showed that RAI therapy did not significantly increase the incidence of breast cancer subsequent to diagnosis of thyroid cancer among patients, when a 2-year latency period was accounted for. An additional finding was that the numbers of breast cancer diagnoses made during the follow-up period for those study participants who received high doses of RAI therapy (greater than or equal to 120 mCi) and those patients who did not receive any RAI therapy were not significantly different from each other.

“The results from our study based on a large cohort of thyroid cancer patients clearly demonstrated that RAI treatment in these patients did not increase the risk of development nor worsen the recurrence of breast cancer,” Dr. Hwa Young Ahn of the department of internal medicine at Seoul National University, South Korea, and Hye Sook Min, and associates.

Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2014-2896).

This study was supported by research grants from the Korean Foundation for Cancer Research, Seoul National University Bundang Hospital Research Grants, and the Education and Research Encouragement Fund of Seoul National University Hospital. The investigators reported having no financial conflicts of interest.

[email protected]

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Oral cholera vaccine reduced incidence of disease

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Oral cholera vaccine reduced incidence of disease

An oral cholera vaccine was effective at reducing the incidence of severely dehydrating cholera and patient presentations of life-threatening cholera according to a cluster-randomized, open-label trial of residents of an urban endemic setting in Bangladesh.

The study’s participants were divided into 90 clusters of individuals targeted as being at high risk for contracting cholera. Patients in one-third of the clusters were offered Shanchol (Shantha Biotechnics–Sanofi ) vaccines. Patients in another third of the clusters were offered the Shanchol vaccine plus instructions and tools for improving hygiene. Patients in the final third of the clusters were not offered either intervention. Government services administered the vaccine as two doses at an interval of at least 14 days. Of the 94,675 patients in the vaccination-only clusters, 65% got vaccinated. Similarly, 66% of the 92,539 patients in the vaccination plus hygienic improvements clusters received vaccinations.

Overall, the vaccine’s effectiveness at protecting against cholera was 37% in the vaccination group and 45% in the vaccination plus hygienic improvements group.

“Our findings show that a routine oral cholera vaccination program in cholera-endemic countries could substantially reduce the burden of disease and greatly contribute to cholera control effects,” said lead author Dr. Firdausi Qadri of the International Centre for Diarrhoeal Disease Research, Bangladesh, in a statement.

The research was funded by the Bill & Melinda Gates Foundation.

Read the full study in the Lancet.

*This story was updated 7/9/2015.

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An oral cholera vaccine was effective at reducing the incidence of severely dehydrating cholera and patient presentations of life-threatening cholera according to a cluster-randomized, open-label trial of residents of an urban endemic setting in Bangladesh.

The study’s participants were divided into 90 clusters of individuals targeted as being at high risk for contracting cholera. Patients in one-third of the clusters were offered Shanchol (Shantha Biotechnics–Sanofi ) vaccines. Patients in another third of the clusters were offered the Shanchol vaccine plus instructions and tools for improving hygiene. Patients in the final third of the clusters were not offered either intervention. Government services administered the vaccine as two doses at an interval of at least 14 days. Of the 94,675 patients in the vaccination-only clusters, 65% got vaccinated. Similarly, 66% of the 92,539 patients in the vaccination plus hygienic improvements clusters received vaccinations.

Overall, the vaccine’s effectiveness at protecting against cholera was 37% in the vaccination group and 45% in the vaccination plus hygienic improvements group.

“Our findings show that a routine oral cholera vaccination program in cholera-endemic countries could substantially reduce the burden of disease and greatly contribute to cholera control effects,” said lead author Dr. Firdausi Qadri of the International Centre for Diarrhoeal Disease Research, Bangladesh, in a statement.

The research was funded by the Bill & Melinda Gates Foundation.

Read the full study in the Lancet.

*This story was updated 7/9/2015.

[email protected]

An oral cholera vaccine was effective at reducing the incidence of severely dehydrating cholera and patient presentations of life-threatening cholera according to a cluster-randomized, open-label trial of residents of an urban endemic setting in Bangladesh.

The study’s participants were divided into 90 clusters of individuals targeted as being at high risk for contracting cholera. Patients in one-third of the clusters were offered Shanchol (Shantha Biotechnics–Sanofi ) vaccines. Patients in another third of the clusters were offered the Shanchol vaccine plus instructions and tools for improving hygiene. Patients in the final third of the clusters were not offered either intervention. Government services administered the vaccine as two doses at an interval of at least 14 days. Of the 94,675 patients in the vaccination-only clusters, 65% got vaccinated. Similarly, 66% of the 92,539 patients in the vaccination plus hygienic improvements clusters received vaccinations.

Overall, the vaccine’s effectiveness at protecting against cholera was 37% in the vaccination group and 45% in the vaccination plus hygienic improvements group.

“Our findings show that a routine oral cholera vaccination program in cholera-endemic countries could substantially reduce the burden of disease and greatly contribute to cholera control effects,” said lead author Dr. Firdausi Qadri of the International Centre for Diarrhoeal Disease Research, Bangladesh, in a statement.

The research was funded by the Bill & Melinda Gates Foundation.

Read the full study in the Lancet.

*This story was updated 7/9/2015.

[email protected]

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FDA probes safety of codeine-containing medicine in children

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FDA probes safety of codeine-containing medicine in children

The Food and Drug Administration wants health care professionals and patients to report adverse events or side effects stemming from codeine-containing medicine use in people under age 18 years to assist it with a new investigation.

The agency is trying to determine if it is safe for people under 18 years of age to treat coughs and colds with codeine-containing medicines, according to a statement released today. These drugs’ potential for causing slowed or difficult breathing was the impetus for the investigation.

The investigation follows the European Medicine Agency’s announcement, in April 2015, that codeine must not be used to treat cough and cold in children under 12 years, and that codeine use is not recommended for people between the ages of 12 and 18 years who have breathing problems, including those with asthma and other chronic breathing problems. In 2013, the FDA issued a statement warning of the risks of codeine use by children who had recently had surgery to remove their tonsils and/or adenoids.

The FDA “will consider the EMA recommendations” and announce its final conclusions and recommendations after it completes the investigation, said the agency in its recent statement.

Reports on problems with codeine-containing medicines can be submitted online at www.fda.gov.MedWatch/report, by fax (1-800-FDA-0178), or by mail. The FDA’s official reporting forms can be obtained by download or by calling 1-800-332-1088 to request a form.

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The Food and Drug Administration wants health care professionals and patients to report adverse events or side effects stemming from codeine-containing medicine use in people under age 18 years to assist it with a new investigation.

The agency is trying to determine if it is safe for people under 18 years of age to treat coughs and colds with codeine-containing medicines, according to a statement released today. These drugs’ potential for causing slowed or difficult breathing was the impetus for the investigation.

The investigation follows the European Medicine Agency’s announcement, in April 2015, that codeine must not be used to treat cough and cold in children under 12 years, and that codeine use is not recommended for people between the ages of 12 and 18 years who have breathing problems, including those with asthma and other chronic breathing problems. In 2013, the FDA issued a statement warning of the risks of codeine use by children who had recently had surgery to remove their tonsils and/or adenoids.

The FDA “will consider the EMA recommendations” and announce its final conclusions and recommendations after it completes the investigation, said the agency in its recent statement.

Reports on problems with codeine-containing medicines can be submitted online at www.fda.gov.MedWatch/report, by fax (1-800-FDA-0178), or by mail. The FDA’s official reporting forms can be obtained by download or by calling 1-800-332-1088 to request a form.

[email protected]

The Food and Drug Administration wants health care professionals and patients to report adverse events or side effects stemming from codeine-containing medicine use in people under age 18 years to assist it with a new investigation.

The agency is trying to determine if it is safe for people under 18 years of age to treat coughs and colds with codeine-containing medicines, according to a statement released today. These drugs’ potential for causing slowed or difficult breathing was the impetus for the investigation.

The investigation follows the European Medicine Agency’s announcement, in April 2015, that codeine must not be used to treat cough and cold in children under 12 years, and that codeine use is not recommended for people between the ages of 12 and 18 years who have breathing problems, including those with asthma and other chronic breathing problems. In 2013, the FDA issued a statement warning of the risks of codeine use by children who had recently had surgery to remove their tonsils and/or adenoids.

The FDA “will consider the EMA recommendations” and announce its final conclusions and recommendations after it completes the investigation, said the agency in its recent statement.

Reports on problems with codeine-containing medicines can be submitted online at www.fda.gov.MedWatch/report, by fax (1-800-FDA-0178), or by mail. The FDA’s official reporting forms can be obtained by download or by calling 1-800-332-1088 to request a form.

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Preventive oral health visits to physicians associated with healthier teeth

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Preventive oral health visits to physicians associated with healthier teeth

Children who saw their physician four or more times for preventive oral health services (POHS) before their third birthday experienced fewer dental caries than those who did not receive such services, according to a retrospective study.

“Medical visits with POHS were associated with a reduction in overall mean [decayed, missing, and filled primary teeth] in children,” noted Ashley M. Kranz, Ph.D., of the University of North Carolina School of Dentistry and colleagues.

POHS included services such as dental screening, application of topical fluoride, and oral health counseling of parents. Surveillance data and North Carolina Medicaid files for 29,173 kindergartners were studied. Of the sample, 69.7% did not receive POHS from physicians, while of the 8,851 who did receive POHS, 51.3% made one visit, 29.3% made two visits, 13.1% made three visits, and 6.3% made at least four visits to a physician that included POHS.

Overall, 47.9% participants in the study had greater than zero decayed, missing, and filled teeth (DMFT), and 25.3% of the children studied had greater than zero untreated decayed teeth (DT) by the time they entered kindergarten. On average, the research subjects had 2.19 DMFT and 0.76 DT.

DMFT differed significantly between children who made 1, 2, 3, and ≥ 4 physician visits with POHS. In fact, DMFT was lowest among the study participants who saw their physician the most times for POHS (mean DMFT = 1.76) and highest among the children who received no POHS from physicians (mean DMFT = 2.23).

Unlike DMFT, DT did not differ significantly between children who made varying amounts of medical visits for POHS.

“Development and testing of strategies to improve the linkage between medical and dental offices are needed to ensure the continuity of care for those children receiving POHS in medical settings,” according to the researchers.

Read the full study in Pediatrics (doi:10.1542/peds/2014-2775).

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Children who saw their physician four or more times for preventive oral health services (POHS) before their third birthday experienced fewer dental caries than those who did not receive such services, according to a retrospective study.

“Medical visits with POHS were associated with a reduction in overall mean [decayed, missing, and filled primary teeth] in children,” noted Ashley M. Kranz, Ph.D., of the University of North Carolina School of Dentistry and colleagues.

POHS included services such as dental screening, application of topical fluoride, and oral health counseling of parents. Surveillance data and North Carolina Medicaid files for 29,173 kindergartners were studied. Of the sample, 69.7% did not receive POHS from physicians, while of the 8,851 who did receive POHS, 51.3% made one visit, 29.3% made two visits, 13.1% made three visits, and 6.3% made at least four visits to a physician that included POHS.

Overall, 47.9% participants in the study had greater than zero decayed, missing, and filled teeth (DMFT), and 25.3% of the children studied had greater than zero untreated decayed teeth (DT) by the time they entered kindergarten. On average, the research subjects had 2.19 DMFT and 0.76 DT.

DMFT differed significantly between children who made 1, 2, 3, and ≥ 4 physician visits with POHS. In fact, DMFT was lowest among the study participants who saw their physician the most times for POHS (mean DMFT = 1.76) and highest among the children who received no POHS from physicians (mean DMFT = 2.23).

Unlike DMFT, DT did not differ significantly between children who made varying amounts of medical visits for POHS.

“Development and testing of strategies to improve the linkage between medical and dental offices are needed to ensure the continuity of care for those children receiving POHS in medical settings,” according to the researchers.

Read the full study in Pediatrics (doi:10.1542/peds/2014-2775).

[email protected]

Children who saw their physician four or more times for preventive oral health services (POHS) before their third birthday experienced fewer dental caries than those who did not receive such services, according to a retrospective study.

“Medical visits with POHS were associated with a reduction in overall mean [decayed, missing, and filled primary teeth] in children,” noted Ashley M. Kranz, Ph.D., of the University of North Carolina School of Dentistry and colleagues.

POHS included services such as dental screening, application of topical fluoride, and oral health counseling of parents. Surveillance data and North Carolina Medicaid files for 29,173 kindergartners were studied. Of the sample, 69.7% did not receive POHS from physicians, while of the 8,851 who did receive POHS, 51.3% made one visit, 29.3% made two visits, 13.1% made three visits, and 6.3% made at least four visits to a physician that included POHS.

Overall, 47.9% participants in the study had greater than zero decayed, missing, and filled teeth (DMFT), and 25.3% of the children studied had greater than zero untreated decayed teeth (DT) by the time they entered kindergarten. On average, the research subjects had 2.19 DMFT and 0.76 DT.

DMFT differed significantly between children who made 1, 2, 3, and ≥ 4 physician visits with POHS. In fact, DMFT was lowest among the study participants who saw their physician the most times for POHS (mean DMFT = 1.76) and highest among the children who received no POHS from physicians (mean DMFT = 2.23).

Unlike DMFT, DT did not differ significantly between children who made varying amounts of medical visits for POHS.

“Development and testing of strategies to improve the linkage between medical and dental offices are needed to ensure the continuity of care for those children receiving POHS in medical settings,” according to the researchers.

Read the full study in Pediatrics (doi:10.1542/peds/2014-2775).

[email protected]

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ACC/HRS/SCAI seek to unify rollout of percutaneous LAA occlusion

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ACC/HRS/SCAI seek to unify rollout of percutaneous LAA occlusion

Three professional societies have published an overview of their opinions on the circumstances under which it is most appropriate to use percutaneous left atrial appendage (LAA) occlusion devices.

In the statement, the American College of Cardiology, Heart Rhythm Society, and Society for Cardiovascular Angiography and Interventions provide their takes on the efficacy of various percutaneous LAA occlusion devices at reducing stroke risk and provide recommendations on when and how to use such devices.

For example, the overview includes criteria for those evaluating the appropriateness of using one of the devices on a particular patient and for those performing an LAA occlusion procedure. It additionally describes where to perform the procedures and what the societies consider to be the necessary protocols for care.

The statement also calls for the creation of various guidelines, asserting that professional societies have a responsibility “to set minimal performance standards for LAA procedures, develop training curriculum, and establish the metrics for evaluation,” and that “specific recommendations for training in LAA occlusion need to developed.”

Additionally, the societies recommend that data on the outcomes of using all LAA occlusion devices be collected and recorded in an existing registry or new registry similar to the transcatheter valve therapy registry.

“This document highlights the critical issues surrounding left atrial appendage occlusion therapies,” said Dr. Frederick A. Masoudi, professor of medicine at the University of Colorado in Denver and chair of the writing committee. “We aimed to facilitate the alignment among patients and their families, primary care physicians, general cardiologists, and additional heart team members and procedural specialists.”

Read the full paper at J. Am. Coll. Cardiol. 2015 [doi:10.1016/j.jacc.2015.06.028].

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Three professional societies have published an overview of their opinions on the circumstances under which it is most appropriate to use percutaneous left atrial appendage (LAA) occlusion devices.

In the statement, the American College of Cardiology, Heart Rhythm Society, and Society for Cardiovascular Angiography and Interventions provide their takes on the efficacy of various percutaneous LAA occlusion devices at reducing stroke risk and provide recommendations on when and how to use such devices.

For example, the overview includes criteria for those evaluating the appropriateness of using one of the devices on a particular patient and for those performing an LAA occlusion procedure. It additionally describes where to perform the procedures and what the societies consider to be the necessary protocols for care.

The statement also calls for the creation of various guidelines, asserting that professional societies have a responsibility “to set minimal performance standards for LAA procedures, develop training curriculum, and establish the metrics for evaluation,” and that “specific recommendations for training in LAA occlusion need to developed.”

Additionally, the societies recommend that data on the outcomes of using all LAA occlusion devices be collected and recorded in an existing registry or new registry similar to the transcatheter valve therapy registry.

“This document highlights the critical issues surrounding left atrial appendage occlusion therapies,” said Dr. Frederick A. Masoudi, professor of medicine at the University of Colorado in Denver and chair of the writing committee. “We aimed to facilitate the alignment among patients and their families, primary care physicians, general cardiologists, and additional heart team members and procedural specialists.”

Read the full paper at J. Am. Coll. Cardiol. 2015 [doi:10.1016/j.jacc.2015.06.028].

[email protected]

Three professional societies have published an overview of their opinions on the circumstances under which it is most appropriate to use percutaneous left atrial appendage (LAA) occlusion devices.

In the statement, the American College of Cardiology, Heart Rhythm Society, and Society for Cardiovascular Angiography and Interventions provide their takes on the efficacy of various percutaneous LAA occlusion devices at reducing stroke risk and provide recommendations on when and how to use such devices.

For example, the overview includes criteria for those evaluating the appropriateness of using one of the devices on a particular patient and for those performing an LAA occlusion procedure. It additionally describes where to perform the procedures and what the societies consider to be the necessary protocols for care.

The statement also calls for the creation of various guidelines, asserting that professional societies have a responsibility “to set minimal performance standards for LAA procedures, develop training curriculum, and establish the metrics for evaluation,” and that “specific recommendations for training in LAA occlusion need to developed.”

Additionally, the societies recommend that data on the outcomes of using all LAA occlusion devices be collected and recorded in an existing registry or new registry similar to the transcatheter valve therapy registry.

“This document highlights the critical issues surrounding left atrial appendage occlusion therapies,” said Dr. Frederick A. Masoudi, professor of medicine at the University of Colorado in Denver and chair of the writing committee. “We aimed to facilitate the alignment among patients and their families, primary care physicians, general cardiologists, and additional heart team members and procedural specialists.”

Read the full paper at J. Am. Coll. Cardiol. 2015 [doi:10.1016/j.jacc.2015.06.028].

[email protected]

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CVD becomes second-largest cause of death in U.K.

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CVD becomes second-largest cause of death in U.K.

For the first time since the middle of the 20th century, cardiovascular disease is not the main cause of death overall in the United Kingdom, according to 2012 data published in Heart.

Cancer narrowly took the lead, with 29% of mortalities in 2012 having resulted from this disease, compared to the 28% of deaths that resulted from cardiovascular disease (CVD). But CVD remains the largest killer of women in the U.K.

In 2012, 28% of all female deaths and 32% of all male deaths were caused by CVD. The highest cause of mortality for men was cancer, with 32% of male deaths having resulted from that disease. A slightly smaller percentage of female deaths – 27% – was caused by cancer than by CVD. The Office for National Statistics (ONS), the National Records of Scotland, and the Northern Ireland Statistics and Research Agency provided the data.

Of the CVD deaths, 46%, or just under 73,500, were from coronary heart disease (CHD) and 26%, or about 41,000, were from stroke.

CVD caused more than a quarter of premature deaths – defined as deaths occurring in people younger than 75 – in men and 18% of premature deaths in women. CHD was the most common cause of premature death in U.K. men.

CVD death rates also varied per region of the United Kingdom, with higher percentages of the populations of Scotland and the north of England having died of CVD than the percentage of people living in the south of England who died from the disease, according to age-standardized death rates by local authorities. Glasgow City, Scotland, had the highest CVD mortality, with 144/100,0000 people having died prematurely and 400/100,000 people having died of the disease.

“The improvements in survival [of people with CVD] mean that there is now a high prevalence of people living with CVD,” according to Prachi Bhatnagar, Ph.D., and her colleagues.

The numbers of people suffering from CHD, stroke, atrial fibrillation and heart failure in the U.K. in 2012 and 2013 were approximately 2.3 million, 1.2 million, 1 million and 480,000, respectively, Quality of Outcomes Framework data suggest. The number of operations carried out to treat CHD is increasing in the United Kingdom, with greater than 90,000 percutaneous coronary interventions (PCIs) having been carried out in 2012 – more than twice as many as had been performed a decade earlier.

“CVD remains a substantial burden to the U.K., both in terms of health and economic costs,” according to the researchers.

Read the full study in Heart (doi:10.1136/heartjnl-2015-307516).

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For the first time since the middle of the 20th century, cardiovascular disease is not the main cause of death overall in the United Kingdom, according to 2012 data published in Heart.

Cancer narrowly took the lead, with 29% of mortalities in 2012 having resulted from this disease, compared to the 28% of deaths that resulted from cardiovascular disease (CVD). But CVD remains the largest killer of women in the U.K.

In 2012, 28% of all female deaths and 32% of all male deaths were caused by CVD. The highest cause of mortality for men was cancer, with 32% of male deaths having resulted from that disease. A slightly smaller percentage of female deaths – 27% – was caused by cancer than by CVD. The Office for National Statistics (ONS), the National Records of Scotland, and the Northern Ireland Statistics and Research Agency provided the data.

Of the CVD deaths, 46%, or just under 73,500, were from coronary heart disease (CHD) and 26%, or about 41,000, were from stroke.

CVD caused more than a quarter of premature deaths – defined as deaths occurring in people younger than 75 – in men and 18% of premature deaths in women. CHD was the most common cause of premature death in U.K. men.

CVD death rates also varied per region of the United Kingdom, with higher percentages of the populations of Scotland and the north of England having died of CVD than the percentage of people living in the south of England who died from the disease, according to age-standardized death rates by local authorities. Glasgow City, Scotland, had the highest CVD mortality, with 144/100,0000 people having died prematurely and 400/100,000 people having died of the disease.

“The improvements in survival [of people with CVD] mean that there is now a high prevalence of people living with CVD,” according to Prachi Bhatnagar, Ph.D., and her colleagues.

The numbers of people suffering from CHD, stroke, atrial fibrillation and heart failure in the U.K. in 2012 and 2013 were approximately 2.3 million, 1.2 million, 1 million and 480,000, respectively, Quality of Outcomes Framework data suggest. The number of operations carried out to treat CHD is increasing in the United Kingdom, with greater than 90,000 percutaneous coronary interventions (PCIs) having been carried out in 2012 – more than twice as many as had been performed a decade earlier.

“CVD remains a substantial burden to the U.K., both in terms of health and economic costs,” according to the researchers.

Read the full study in Heart (doi:10.1136/heartjnl-2015-307516).

[email protected]

For the first time since the middle of the 20th century, cardiovascular disease is not the main cause of death overall in the United Kingdom, according to 2012 data published in Heart.

Cancer narrowly took the lead, with 29% of mortalities in 2012 having resulted from this disease, compared to the 28% of deaths that resulted from cardiovascular disease (CVD). But CVD remains the largest killer of women in the U.K.

In 2012, 28% of all female deaths and 32% of all male deaths were caused by CVD. The highest cause of mortality for men was cancer, with 32% of male deaths having resulted from that disease. A slightly smaller percentage of female deaths – 27% – was caused by cancer than by CVD. The Office for National Statistics (ONS), the National Records of Scotland, and the Northern Ireland Statistics and Research Agency provided the data.

Of the CVD deaths, 46%, or just under 73,500, were from coronary heart disease (CHD) and 26%, or about 41,000, were from stroke.

CVD caused more than a quarter of premature deaths – defined as deaths occurring in people younger than 75 – in men and 18% of premature deaths in women. CHD was the most common cause of premature death in U.K. men.

CVD death rates also varied per region of the United Kingdom, with higher percentages of the populations of Scotland and the north of England having died of CVD than the percentage of people living in the south of England who died from the disease, according to age-standardized death rates by local authorities. Glasgow City, Scotland, had the highest CVD mortality, with 144/100,0000 people having died prematurely and 400/100,000 people having died of the disease.

“The improvements in survival [of people with CVD] mean that there is now a high prevalence of people living with CVD,” according to Prachi Bhatnagar, Ph.D., and her colleagues.

The numbers of people suffering from CHD, stroke, atrial fibrillation and heart failure in the U.K. in 2012 and 2013 were approximately 2.3 million, 1.2 million, 1 million and 480,000, respectively, Quality of Outcomes Framework data suggest. The number of operations carried out to treat CHD is increasing in the United Kingdom, with greater than 90,000 percutaneous coronary interventions (PCIs) having been carried out in 2012 – more than twice as many as had been performed a decade earlier.

“CVD remains a substantial burden to the U.K., both in terms of health and economic costs,” according to the researchers.

Read the full study in Heart (doi:10.1136/heartjnl-2015-307516).

[email protected]

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Obesity, genetic variations found in adult survivors of childhood cancer

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Obesity, genetic variations found in adult survivors of childhood cancer

The St. Jude Lifetime Cohort study found obesity in a higher percentage of adult survivors of childhood cancer than previous studies.

Thirty-six percent of the research project’s 1,996 participants were obese, which the study defined as having a body mass index (BMI) of greater than or equal to 30 kg/m2. All of the study’s participants previously had received treatment for cancer at St. Jude Children’s Research Hospital, Memphis, Tenn., and had been cancer survivors for at least 10 years.

The prevalence of obesity was even higher in the subset of the sample that had been treated with cranial radiation (CRT). Forty-five percent of such survivors were obese, compared to 29.4% of the study’s participants, who had not been exposed to CRT. Another finding specific to the cancer survivors that had received CRT were associations between obesity, and variations in the regions in and around the genes FAM155A, GLRA3, CDH18, and SOX11.

“Because both CDH18 and SOX11 appear to influence neuronal growth, repair, and connectivity, these genes may be important regulators of neuronal response to radiation-induced damage among CCS,” according to Carmen L. Wilson, Ph.D., and her colleagues. They added that single nucleotide polymorphisms in such genes could alter obesity risk but said more research needs to be conducted to confirm this.

Among the study’s other findings were that older age at evaluation, previous treatment with CRT, and glucocorticoid exposures were independently associated with obesity. Chest, abdominal, or pelvic, radiation exposure, in contrast, were negatively correlated with having a BMI at or above 30 kg/m2.

The study has confirmed that “the high prevalence of obesity among [survivors of childhood cancer] persists decades after cancer treatment and appears to be influenced by therapies received during childhood and obesity status at diagnosis,” according to the researchers.

Read the full study in Cancer (doi: 10.10002/cncr.29153).

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The St. Jude Lifetime Cohort study found obesity in a higher percentage of adult survivors of childhood cancer than previous studies.

Thirty-six percent of the research project’s 1,996 participants were obese, which the study defined as having a body mass index (BMI) of greater than or equal to 30 kg/m2. All of the study’s participants previously had received treatment for cancer at St. Jude Children’s Research Hospital, Memphis, Tenn., and had been cancer survivors for at least 10 years.

The prevalence of obesity was even higher in the subset of the sample that had been treated with cranial radiation (CRT). Forty-five percent of such survivors were obese, compared to 29.4% of the study’s participants, who had not been exposed to CRT. Another finding specific to the cancer survivors that had received CRT were associations between obesity, and variations in the regions in and around the genes FAM155A, GLRA3, CDH18, and SOX11.

“Because both CDH18 and SOX11 appear to influence neuronal growth, repair, and connectivity, these genes may be important regulators of neuronal response to radiation-induced damage among CCS,” according to Carmen L. Wilson, Ph.D., and her colleagues. They added that single nucleotide polymorphisms in such genes could alter obesity risk but said more research needs to be conducted to confirm this.

Among the study’s other findings were that older age at evaluation, previous treatment with CRT, and glucocorticoid exposures were independently associated with obesity. Chest, abdominal, or pelvic, radiation exposure, in contrast, were negatively correlated with having a BMI at or above 30 kg/m2.

The study has confirmed that “the high prevalence of obesity among [survivors of childhood cancer] persists decades after cancer treatment and appears to be influenced by therapies received during childhood and obesity status at diagnosis,” according to the researchers.

Read the full study in Cancer (doi: 10.10002/cncr.29153).

The St. Jude Lifetime Cohort study found obesity in a higher percentage of adult survivors of childhood cancer than previous studies.

Thirty-six percent of the research project’s 1,996 participants were obese, which the study defined as having a body mass index (BMI) of greater than or equal to 30 kg/m2. All of the study’s participants previously had received treatment for cancer at St. Jude Children’s Research Hospital, Memphis, Tenn., and had been cancer survivors for at least 10 years.

The prevalence of obesity was even higher in the subset of the sample that had been treated with cranial radiation (CRT). Forty-five percent of such survivors were obese, compared to 29.4% of the study’s participants, who had not been exposed to CRT. Another finding specific to the cancer survivors that had received CRT were associations between obesity, and variations in the regions in and around the genes FAM155A, GLRA3, CDH18, and SOX11.

“Because both CDH18 and SOX11 appear to influence neuronal growth, repair, and connectivity, these genes may be important regulators of neuronal response to radiation-induced damage among CCS,” according to Carmen L. Wilson, Ph.D., and her colleagues. They added that single nucleotide polymorphisms in such genes could alter obesity risk but said more research needs to be conducted to confirm this.

Among the study’s other findings were that older age at evaluation, previous treatment with CRT, and glucocorticoid exposures were independently associated with obesity. Chest, abdominal, or pelvic, radiation exposure, in contrast, were negatively correlated with having a BMI at or above 30 kg/m2.

The study has confirmed that “the high prevalence of obesity among [survivors of childhood cancer] persists decades after cancer treatment and appears to be influenced by therapies received during childhood and obesity status at diagnosis,” according to the researchers.

Read the full study in Cancer (doi: 10.10002/cncr.29153).

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