Social media use linked to 10% increase in risk of new ADHD symptoms among teens

Parents should be involved in children’s media use
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Adolescents who frequently used digital media were more likely to develop subsequent symptoms of ADHD over a 2 year period, according to results from a prospective, longitudinal cohort study published in JAMA.

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“Further research is needed to determine whether this association is causal,” cautioned the investigators.

Between fall 2014 (10th grade) and fall 2016 (12th grade), researchers studied 3,051 students from 10 different Los Angeles schools who were enrolled in the Happiness & Health Study and did not have significant ADHD symptoms; of these students, 2,587 adolescents (mean age 16 years, 54% girls) self-reported digital media use activities from 14 different types through surveys administered at baseline and again at 6-month, 12-month, 18-month and 24-month follow-up. Digital use activities included checking social media sites, engaging with social media content, texting, streaming music, and browsing or viewing images or videos, among others.

“Although some emerging research indicates that ADHD levels and use of certain forms of modern media may be concurrently associated, the role of modern digital media use in ADHD risk largely remains unclear from the prior literature due to limitations in exposure assessment and the application of designs incapable of supporting temporal or causal inferences,” wrote Chaelin K. Ra, MPH, of the University of Southern California, Los Angeles, and his colleagues. “The current study provides new longitudinal evidence on this topic using a 5-wave prospective design and comprehensive assessment across a wide continuum of digital media exposure, including numerous media platforms currently popular among youth.”

Students ranked their activities in a cumulative index and indicated whether they participated in those activities “0, 1-2 times per week, 1-2 times per day, or many times per day.” They also filled out the DSM-IV Current Symptoms Self-Report Form, which asked them to report whether they experienced any of nine different hyperactivity-impulsivity symptoms such as “difficulty organizing and completing tasks.”

Mr. Ra and his colleagues found that 81% of adolescents reported at least one digital media activity performed at a high-frequency rate, with 54% reporting they checked social media at a high-frequency rate. There was a mean of four baseline digital media activities performed at a high-frequency rate among students surveyed. Each additional digital media activity used at a high-frequency rate carried a statistically significant association of subsequent ADHD symptoms over the follow-up period (odds ratio 1.1; 95% confidence interval, 1.06-1.16), which remained after adjustment for covariates including age, sex, and subsidized lunch availability tied to family income (OR 1.1; 95% CI, 1.05-1.15). The researchers noted that there was a 5% mean prevalence of subsequent ADHD symptoms in follow-up among patients who reported no baseline high-frequency rate of digital media use, compared with 10% in students indicating 7 high-frequency activities and 11% in students indicating 14 high-frequency activities.

Limitations of the study included potential inaccuracies in self-reporting ADHD symptoms as opposed to students receiving a diagnosis through a clinical interview, the possibility of the association being influenced by ADHD symptoms not detected in the study, the fact that the media use measure in the study had not been validated, and use of a targeted age range in the sample of students that excluded students without surveys who had differing demographic data from the rest of the cohort, according to the researchers.

The authors reported having no relevant financial disclosures. The study was supported by a grant from the National Institutes of Health.

SOURCE: Ra CK et al. JAMA. 2018 Jul 17. doi: 10.1001/jama.2018.8931.

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This study is among the first to capture current media use because technology tends to outpace researchers’ ability to publish data “within relevant time frames,” Jenny Radesky, MD of the University of Michigan in Ann Arbor, said in an editorial.

While previous studies linking ADHD symptoms and media use analyzed use of media such as television shows and video games, this study analyzes smartphone use and “always-on” media such as social media in addition to traditional media, she said.

It should be noted that “high-frequency media use was associated with only a 10% increased risk of later ADHD symptoms overall.

“Although the authors were able to adjust for income and mental health symptoms, they did not assess parent media use or whether the parents were involved in how the adolescents used media,” Dr. Radesky said. “Parent media use correlates with child media use, may interrupt parent-child activities, and is associated with child behavior difficulties in younger children.”

She said the study affirms guidelines from the American Academy of Pediatrics to “prioritize activities that promote adolescent executive functioning and well-being, including sleep, physical activity, distraction-free homework, and positive interactions with family and friends.

“Although not directly addressed by this study, the American Academy of Pediatrics recommendations for parent involvement in their adolescent’s media use – including discussions about prosocial uses of media, digital citizenship, misinformation, and persuasion awareness – are relevant to the cognitive and emotional reactions to digital media of adolescents,” she added.

Dr. Radesky noted that the potential for the association between media use and ADHD symptoms to be influenced by confounders not measured in the study is a “major limitation.”

Dr. Radesky is at the University of Michigan, Ann Arbor. She receives grant support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. These comments summarize her editorial accompanying the article by Ra et al. ( JAMA. 2018;320:237-39 ).

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This study is among the first to capture current media use because technology tends to outpace researchers’ ability to publish data “within relevant time frames,” Jenny Radesky, MD of the University of Michigan in Ann Arbor, said in an editorial.

While previous studies linking ADHD symptoms and media use analyzed use of media such as television shows and video games, this study analyzes smartphone use and “always-on” media such as social media in addition to traditional media, she said.

It should be noted that “high-frequency media use was associated with only a 10% increased risk of later ADHD symptoms overall.

“Although the authors were able to adjust for income and mental health symptoms, they did not assess parent media use or whether the parents were involved in how the adolescents used media,” Dr. Radesky said. “Parent media use correlates with child media use, may interrupt parent-child activities, and is associated with child behavior difficulties in younger children.”

She said the study affirms guidelines from the American Academy of Pediatrics to “prioritize activities that promote adolescent executive functioning and well-being, including sleep, physical activity, distraction-free homework, and positive interactions with family and friends.

“Although not directly addressed by this study, the American Academy of Pediatrics recommendations for parent involvement in their adolescent’s media use – including discussions about prosocial uses of media, digital citizenship, misinformation, and persuasion awareness – are relevant to the cognitive and emotional reactions to digital media of adolescents,” she added.

Dr. Radesky noted that the potential for the association between media use and ADHD symptoms to be influenced by confounders not measured in the study is a “major limitation.”

Dr. Radesky is at the University of Michigan, Ann Arbor. She receives grant support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. These comments summarize her editorial accompanying the article by Ra et al. ( JAMA. 2018;320:237-39 ).

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This study is among the first to capture current media use because technology tends to outpace researchers’ ability to publish data “within relevant time frames,” Jenny Radesky, MD of the University of Michigan in Ann Arbor, said in an editorial.

While previous studies linking ADHD symptoms and media use analyzed use of media such as television shows and video games, this study analyzes smartphone use and “always-on” media such as social media in addition to traditional media, she said.

It should be noted that “high-frequency media use was associated with only a 10% increased risk of later ADHD symptoms overall.

“Although the authors were able to adjust for income and mental health symptoms, they did not assess parent media use or whether the parents were involved in how the adolescents used media,” Dr. Radesky said. “Parent media use correlates with child media use, may interrupt parent-child activities, and is associated with child behavior difficulties in younger children.”

She said the study affirms guidelines from the American Academy of Pediatrics to “prioritize activities that promote adolescent executive functioning and well-being, including sleep, physical activity, distraction-free homework, and positive interactions with family and friends.

“Although not directly addressed by this study, the American Academy of Pediatrics recommendations for parent involvement in their adolescent’s media use – including discussions about prosocial uses of media, digital citizenship, misinformation, and persuasion awareness – are relevant to the cognitive and emotional reactions to digital media of adolescents,” she added.

Dr. Radesky noted that the potential for the association between media use and ADHD symptoms to be influenced by confounders not measured in the study is a “major limitation.”

Dr. Radesky is at the University of Michigan, Ann Arbor. She receives grant support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. These comments summarize her editorial accompanying the article by Ra et al. ( JAMA. 2018;320:237-39 ).

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Parents should be involved in children’s media use
Parents should be involved in children’s media use

Adolescents who frequently used digital media were more likely to develop subsequent symptoms of ADHD over a 2 year period, according to results from a prospective, longitudinal cohort study published in JAMA.

monkeybusinessimages/iStock/Getty Images Plus

“Further research is needed to determine whether this association is causal,” cautioned the investigators.

Between fall 2014 (10th grade) and fall 2016 (12th grade), researchers studied 3,051 students from 10 different Los Angeles schools who were enrolled in the Happiness & Health Study and did not have significant ADHD symptoms; of these students, 2,587 adolescents (mean age 16 years, 54% girls) self-reported digital media use activities from 14 different types through surveys administered at baseline and again at 6-month, 12-month, 18-month and 24-month follow-up. Digital use activities included checking social media sites, engaging with social media content, texting, streaming music, and browsing or viewing images or videos, among others.

“Although some emerging research indicates that ADHD levels and use of certain forms of modern media may be concurrently associated, the role of modern digital media use in ADHD risk largely remains unclear from the prior literature due to limitations in exposure assessment and the application of designs incapable of supporting temporal or causal inferences,” wrote Chaelin K. Ra, MPH, of the University of Southern California, Los Angeles, and his colleagues. “The current study provides new longitudinal evidence on this topic using a 5-wave prospective design and comprehensive assessment across a wide continuum of digital media exposure, including numerous media platforms currently popular among youth.”

Students ranked their activities in a cumulative index and indicated whether they participated in those activities “0, 1-2 times per week, 1-2 times per day, or many times per day.” They also filled out the DSM-IV Current Symptoms Self-Report Form, which asked them to report whether they experienced any of nine different hyperactivity-impulsivity symptoms such as “difficulty organizing and completing tasks.”

Mr. Ra and his colleagues found that 81% of adolescents reported at least one digital media activity performed at a high-frequency rate, with 54% reporting they checked social media at a high-frequency rate. There was a mean of four baseline digital media activities performed at a high-frequency rate among students surveyed. Each additional digital media activity used at a high-frequency rate carried a statistically significant association of subsequent ADHD symptoms over the follow-up period (odds ratio 1.1; 95% confidence interval, 1.06-1.16), which remained after adjustment for covariates including age, sex, and subsidized lunch availability tied to family income (OR 1.1; 95% CI, 1.05-1.15). The researchers noted that there was a 5% mean prevalence of subsequent ADHD symptoms in follow-up among patients who reported no baseline high-frequency rate of digital media use, compared with 10% in students indicating 7 high-frequency activities and 11% in students indicating 14 high-frequency activities.

Limitations of the study included potential inaccuracies in self-reporting ADHD symptoms as opposed to students receiving a diagnosis through a clinical interview, the possibility of the association being influenced by ADHD symptoms not detected in the study, the fact that the media use measure in the study had not been validated, and use of a targeted age range in the sample of students that excluded students without surveys who had differing demographic data from the rest of the cohort, according to the researchers.

The authors reported having no relevant financial disclosures. The study was supported by a grant from the National Institutes of Health.

SOURCE: Ra CK et al. JAMA. 2018 Jul 17. doi: 10.1001/jama.2018.8931.

Adolescents who frequently used digital media were more likely to develop subsequent symptoms of ADHD over a 2 year period, according to results from a prospective, longitudinal cohort study published in JAMA.

monkeybusinessimages/iStock/Getty Images Plus

“Further research is needed to determine whether this association is causal,” cautioned the investigators.

Between fall 2014 (10th grade) and fall 2016 (12th grade), researchers studied 3,051 students from 10 different Los Angeles schools who were enrolled in the Happiness & Health Study and did not have significant ADHD symptoms; of these students, 2,587 adolescents (mean age 16 years, 54% girls) self-reported digital media use activities from 14 different types through surveys administered at baseline and again at 6-month, 12-month, 18-month and 24-month follow-up. Digital use activities included checking social media sites, engaging with social media content, texting, streaming music, and browsing or viewing images or videos, among others.

“Although some emerging research indicates that ADHD levels and use of certain forms of modern media may be concurrently associated, the role of modern digital media use in ADHD risk largely remains unclear from the prior literature due to limitations in exposure assessment and the application of designs incapable of supporting temporal or causal inferences,” wrote Chaelin K. Ra, MPH, of the University of Southern California, Los Angeles, and his colleagues. “The current study provides new longitudinal evidence on this topic using a 5-wave prospective design and comprehensive assessment across a wide continuum of digital media exposure, including numerous media platforms currently popular among youth.”

Students ranked their activities in a cumulative index and indicated whether they participated in those activities “0, 1-2 times per week, 1-2 times per day, or many times per day.” They also filled out the DSM-IV Current Symptoms Self-Report Form, which asked them to report whether they experienced any of nine different hyperactivity-impulsivity symptoms such as “difficulty organizing and completing tasks.”

Mr. Ra and his colleagues found that 81% of adolescents reported at least one digital media activity performed at a high-frequency rate, with 54% reporting they checked social media at a high-frequency rate. There was a mean of four baseline digital media activities performed at a high-frequency rate among students surveyed. Each additional digital media activity used at a high-frequency rate carried a statistically significant association of subsequent ADHD symptoms over the follow-up period (odds ratio 1.1; 95% confidence interval, 1.06-1.16), which remained after adjustment for covariates including age, sex, and subsidized lunch availability tied to family income (OR 1.1; 95% CI, 1.05-1.15). The researchers noted that there was a 5% mean prevalence of subsequent ADHD symptoms in follow-up among patients who reported no baseline high-frequency rate of digital media use, compared with 10% in students indicating 7 high-frequency activities and 11% in students indicating 14 high-frequency activities.

Limitations of the study included potential inaccuracies in self-reporting ADHD symptoms as opposed to students receiving a diagnosis through a clinical interview, the possibility of the association being influenced by ADHD symptoms not detected in the study, the fact that the media use measure in the study had not been validated, and use of a targeted age range in the sample of students that excluded students without surveys who had differing demographic data from the rest of the cohort, according to the researchers.

The authors reported having no relevant financial disclosures. The study was supported by a grant from the National Institutes of Health.

SOURCE: Ra CK et al. JAMA. 2018 Jul 17. doi: 10.1001/jama.2018.8931.

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Key clinical point: High-frequency digital media use carries a statistically significant association with subsequent ADHD symptoms in adolescent students without previous significant ADHD symptoms at baseline.

Major finding: Of the adolescent students without significant ADHD symptoms, there was a 1.1 odds ratio for subsequent ADHD symptoms with each additional high-frequency digital media activity.

Study details: A prospective, longitudinal study of 3,051 adolescent students (mean age, 16 years) in the Happiness & Health Study, followed for 24 months.

Disclosures: The authors reported having no relevant financial disclosures. The study was supported by a grant from the National Institutes of Health.

Source: Ra CK et al. JAMA. 2018 Jul 17. doi: 10.1001/jama.2018.8931.

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ACA coverage mandate leads to more insurance for young women, early gynecologic cancer diagnoses

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Young women are more likely to be insured and diagnosed with gynecologic cancers at an early stage after the Affordable Care Act’s dependent coverage mandate than before the mandate went into effect, according to a new study from Johns Hopkins University School of Medicine.

“We know if these women are identified early and treated early, they are much more likely to live longer and have their cancer go into remission,” Anna Jo Bodurtha Smith, MD, MPH, of Johns Hopkins University, Baltimore, stated in a press release.

Dr. Smith and her colleague, Amanda N. Fader, MD, evaluated 1,912 gynecologic cancer cases before the Affordable Care Act (ACA) and 2,059 cases after the ACA in women who were aged 21-26 years. They also analyzed 9,782 and 10,456 pre-ACA and post-ACA cases in women aged 27-35 years. The researchers obtained the pre-ACA data, which included cases of uterine, cervical, vaginal and vulvar cancer, from the 2006-2009 surveys in the National Cancer Database; post-ACA data were obtained from the 2011-2014 surveys in the same database. Using a difference-in-differences study design to compare both age groups, they assessed factors such as diagnosis stage, insurance status, and whether the patients received fertility-sparing treatment. The study results were published in Obstetrics & Gynecology.

The researchers found post-ACA insurance coverage increased (difference in differences, 2.2%; 95% confidence interval, −4.0 to 0.1; P = .04) in women aged 21-26 years, compared with women aged 27-35 years, with a significant increase in cases of gynecological cancer being detected early (difference in differences, 3.6%; 95% CI, 0.4-6.9; P = .03) in the women aged 21-26 years, compared with women aged 27-35 years. While both groups showed an increase in fertility-sparing treatments post ACA, there was no significant difference in differences between the two groups.

Insurance status affected whether women were diagnosed with gynecologic cancer early or received fertility-sparing treatment, as women who were privately insured had a greater likelihood of early diagnoses of gynecologic cancer and receiving fertility-sparing treatment, compared with women who were publicly insured or did not have insurance.

“As the debate on how we insure women goes on, reminding ourselves that these insurance gains have huge impacts on people’s lives is the big takeaway here,” Dr. Smith stated in the release.

Researchers noted limitations to the study included its 80% power to detect overall pre-post differences of 4% due to its design, lack of power due to the small sample size for women with gynecologic cancer in the younger cohort, and change in coverage status due to external economic factors.

The authors reported no relevant financial disclosures.

SOURCE: Smith AJB, Fader AN. Obstet Gynecol. 2018 Jun. doi: 10.1097/AOG.0000000000002592.

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Young women are more likely to be insured and diagnosed with gynecologic cancers at an early stage after the Affordable Care Act’s dependent coverage mandate than before the mandate went into effect, according to a new study from Johns Hopkins University School of Medicine.

“We know if these women are identified early and treated early, they are much more likely to live longer and have their cancer go into remission,” Anna Jo Bodurtha Smith, MD, MPH, of Johns Hopkins University, Baltimore, stated in a press release.

Dr. Smith and her colleague, Amanda N. Fader, MD, evaluated 1,912 gynecologic cancer cases before the Affordable Care Act (ACA) and 2,059 cases after the ACA in women who were aged 21-26 years. They also analyzed 9,782 and 10,456 pre-ACA and post-ACA cases in women aged 27-35 years. The researchers obtained the pre-ACA data, which included cases of uterine, cervical, vaginal and vulvar cancer, from the 2006-2009 surveys in the National Cancer Database; post-ACA data were obtained from the 2011-2014 surveys in the same database. Using a difference-in-differences study design to compare both age groups, they assessed factors such as diagnosis stage, insurance status, and whether the patients received fertility-sparing treatment. The study results were published in Obstetrics & Gynecology.

The researchers found post-ACA insurance coverage increased (difference in differences, 2.2%; 95% confidence interval, −4.0 to 0.1; P = .04) in women aged 21-26 years, compared with women aged 27-35 years, with a significant increase in cases of gynecological cancer being detected early (difference in differences, 3.6%; 95% CI, 0.4-6.9; P = .03) in the women aged 21-26 years, compared with women aged 27-35 years. While both groups showed an increase in fertility-sparing treatments post ACA, there was no significant difference in differences between the two groups.

Insurance status affected whether women were diagnosed with gynecologic cancer early or received fertility-sparing treatment, as women who were privately insured had a greater likelihood of early diagnoses of gynecologic cancer and receiving fertility-sparing treatment, compared with women who were publicly insured or did not have insurance.

“As the debate on how we insure women goes on, reminding ourselves that these insurance gains have huge impacts on people’s lives is the big takeaway here,” Dr. Smith stated in the release.

Researchers noted limitations to the study included its 80% power to detect overall pre-post differences of 4% due to its design, lack of power due to the small sample size for women with gynecologic cancer in the younger cohort, and change in coverage status due to external economic factors.

The authors reported no relevant financial disclosures.

SOURCE: Smith AJB, Fader AN. Obstet Gynecol. 2018 Jun. doi: 10.1097/AOG.0000000000002592.

 

Young women are more likely to be insured and diagnosed with gynecologic cancers at an early stage after the Affordable Care Act’s dependent coverage mandate than before the mandate went into effect, according to a new study from Johns Hopkins University School of Medicine.

“We know if these women are identified early and treated early, they are much more likely to live longer and have their cancer go into remission,” Anna Jo Bodurtha Smith, MD, MPH, of Johns Hopkins University, Baltimore, stated in a press release.

Dr. Smith and her colleague, Amanda N. Fader, MD, evaluated 1,912 gynecologic cancer cases before the Affordable Care Act (ACA) and 2,059 cases after the ACA in women who were aged 21-26 years. They also analyzed 9,782 and 10,456 pre-ACA and post-ACA cases in women aged 27-35 years. The researchers obtained the pre-ACA data, which included cases of uterine, cervical, vaginal and vulvar cancer, from the 2006-2009 surveys in the National Cancer Database; post-ACA data were obtained from the 2011-2014 surveys in the same database. Using a difference-in-differences study design to compare both age groups, they assessed factors such as diagnosis stage, insurance status, and whether the patients received fertility-sparing treatment. The study results were published in Obstetrics & Gynecology.

The researchers found post-ACA insurance coverage increased (difference in differences, 2.2%; 95% confidence interval, −4.0 to 0.1; P = .04) in women aged 21-26 years, compared with women aged 27-35 years, with a significant increase in cases of gynecological cancer being detected early (difference in differences, 3.6%; 95% CI, 0.4-6.9; P = .03) in the women aged 21-26 years, compared with women aged 27-35 years. While both groups showed an increase in fertility-sparing treatments post ACA, there was no significant difference in differences between the two groups.

Insurance status affected whether women were diagnosed with gynecologic cancer early or received fertility-sparing treatment, as women who were privately insured had a greater likelihood of early diagnoses of gynecologic cancer and receiving fertility-sparing treatment, compared with women who were publicly insured or did not have insurance.

“As the debate on how we insure women goes on, reminding ourselves that these insurance gains have huge impacts on people’s lives is the big takeaway here,” Dr. Smith stated in the release.

Researchers noted limitations to the study included its 80% power to detect overall pre-post differences of 4% due to its design, lack of power due to the small sample size for women with gynecologic cancer in the younger cohort, and change in coverage status due to external economic factors.

The authors reported no relevant financial disclosures.

SOURCE: Smith AJB, Fader AN. Obstet Gynecol. 2018 Jun. doi: 10.1097/AOG.0000000000002592.

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Key clinical point: Under the Affordable Care Act dependent coverage mandate, more young women are likely to be insured and receive early gynecological cancer diagnoses than before the law was passed.

Major finding: There was a 2.2% increase in insured young women and a 3.6% increase in early cancer diagnoses, according to a difference-in-differences model.

Data source: An analysis of 1,912 pre-ACA and 2,059 post-ACA gynecologic cancer cases in women aged 21-26 years and 9,782 pre-ACA and 10,456 post-ACA cases in women aged 27-35 years obtained from the National Cancer Center Database in a study with a difference-in-differences design.

Disclosures: The authors reported no relevant financial disclosures.

Source: Smith AJB, Fader AN. Obstet Gynecol. 2018 Jun. doi: 10.1097/AOG.0000000000002592.

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Older black patients die sooner after in-hospital cardiac arrest

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Older black adults who experienced in-hospital cardiac arrest had a 28% lower relative risk of living to 1 year and a 33% lower relative risk of living to 5 years after discharge, compared with older white adults, suggesting potential racial differences in postdischarge care, according to an article published in Circulation.

The investigators examined data for 8,764 patients in the Get With The Guidelines–Resuscitation registry who were at least 65 years of age and experienced in-hospital cardiac arrest (IHCA) during 2000-2011 and then survived to be discharged. They linked patients to Medicare claims data and tracked survival outcomes for 1 year, 3 years, and 5 years, and evaluated the “proportion of racial differences explained by patient, hospital, and unmeasured factors.”

After discharge and adjustment for hospital site, investigators found older black patients had a 28% lower survival rate, compared with older white patients, at 1 year (43.6% vs. 60.2%), a 29% lower rate at 3 years (31.6% vs. 45.3%), and a 33% lower rate at 5 years (23.5% vs. 35.4%), all statistically significant at P less than .001. While patient factors accounted for 29% and hospital treatment factors accounted for 17% of racial differences at 1 year after discharge, about one-half of the differences remained unexplained. Investigators said these racial differences were potentially “result of differences in care after discharge or unmeasured confounding,” and “generally similar” results were seen in patients at 3 years and 5 years post discharge.

“This finding suggests a need to examine whether racial differences in postdischarge care explain a substantial proportion of racial differences in long-term survival after in-hospital cardiac arrest,” Lena M. Chen, MD, of the University of Michigan, Ann Arbor, and her colleagues wrote in Circulation.

The investigators noted they were unable to determine patient socioeconomic status, income, and social support with the available data, and did not know whether patients used or had an outpatient medical center near them after discharge. Furthermore, the study comprised older adults with fee-for-service Medicare and isn’t necessarily indicative of care for younger adults.

“Further investigation is warranted to better understand whether modifiable aspects of postdischarge care account for the remaining differences and whether interventions can be developed to eliminate racial disparities in care and survival for cardiac arrest survivors,” Dr. Chen and colleagues wrote.

This project was supported by a grant from the American Heart Association Young Investigator Research Seed. Dr. Chen received funding support from the Agency for Healthcare Research and Quality and the National Institute on Aging. Dr. Chen and another investigator received funding support from the National Heart, Lung, and Blood Institute.

SOURCE: Chen LM. Circulation. 2018 Jul 9. doi: 10.1161/circulationaha.117.033211.

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Older black adults who experienced in-hospital cardiac arrest had a 28% lower relative risk of living to 1 year and a 33% lower relative risk of living to 5 years after discharge, compared with older white adults, suggesting potential racial differences in postdischarge care, according to an article published in Circulation.

The investigators examined data for 8,764 patients in the Get With The Guidelines–Resuscitation registry who were at least 65 years of age and experienced in-hospital cardiac arrest (IHCA) during 2000-2011 and then survived to be discharged. They linked patients to Medicare claims data and tracked survival outcomes for 1 year, 3 years, and 5 years, and evaluated the “proportion of racial differences explained by patient, hospital, and unmeasured factors.”

After discharge and adjustment for hospital site, investigators found older black patients had a 28% lower survival rate, compared with older white patients, at 1 year (43.6% vs. 60.2%), a 29% lower rate at 3 years (31.6% vs. 45.3%), and a 33% lower rate at 5 years (23.5% vs. 35.4%), all statistically significant at P less than .001. While patient factors accounted for 29% and hospital treatment factors accounted for 17% of racial differences at 1 year after discharge, about one-half of the differences remained unexplained. Investigators said these racial differences were potentially “result of differences in care after discharge or unmeasured confounding,” and “generally similar” results were seen in patients at 3 years and 5 years post discharge.

“This finding suggests a need to examine whether racial differences in postdischarge care explain a substantial proportion of racial differences in long-term survival after in-hospital cardiac arrest,” Lena M. Chen, MD, of the University of Michigan, Ann Arbor, and her colleagues wrote in Circulation.

The investigators noted they were unable to determine patient socioeconomic status, income, and social support with the available data, and did not know whether patients used or had an outpatient medical center near them after discharge. Furthermore, the study comprised older adults with fee-for-service Medicare and isn’t necessarily indicative of care for younger adults.

“Further investigation is warranted to better understand whether modifiable aspects of postdischarge care account for the remaining differences and whether interventions can be developed to eliminate racial disparities in care and survival for cardiac arrest survivors,” Dr. Chen and colleagues wrote.

This project was supported by a grant from the American Heart Association Young Investigator Research Seed. Dr. Chen received funding support from the Agency for Healthcare Research and Quality and the National Institute on Aging. Dr. Chen and another investigator received funding support from the National Heart, Lung, and Blood Institute.

SOURCE: Chen LM. Circulation. 2018 Jul 9. doi: 10.1161/circulationaha.117.033211.

 

Older black adults who experienced in-hospital cardiac arrest had a 28% lower relative risk of living to 1 year and a 33% lower relative risk of living to 5 years after discharge, compared with older white adults, suggesting potential racial differences in postdischarge care, according to an article published in Circulation.

The investigators examined data for 8,764 patients in the Get With The Guidelines–Resuscitation registry who were at least 65 years of age and experienced in-hospital cardiac arrest (IHCA) during 2000-2011 and then survived to be discharged. They linked patients to Medicare claims data and tracked survival outcomes for 1 year, 3 years, and 5 years, and evaluated the “proportion of racial differences explained by patient, hospital, and unmeasured factors.”

After discharge and adjustment for hospital site, investigators found older black patients had a 28% lower survival rate, compared with older white patients, at 1 year (43.6% vs. 60.2%), a 29% lower rate at 3 years (31.6% vs. 45.3%), and a 33% lower rate at 5 years (23.5% vs. 35.4%), all statistically significant at P less than .001. While patient factors accounted for 29% and hospital treatment factors accounted for 17% of racial differences at 1 year after discharge, about one-half of the differences remained unexplained. Investigators said these racial differences were potentially “result of differences in care after discharge or unmeasured confounding,” and “generally similar” results were seen in patients at 3 years and 5 years post discharge.

“This finding suggests a need to examine whether racial differences in postdischarge care explain a substantial proportion of racial differences in long-term survival after in-hospital cardiac arrest,” Lena M. Chen, MD, of the University of Michigan, Ann Arbor, and her colleagues wrote in Circulation.

The investigators noted they were unable to determine patient socioeconomic status, income, and social support with the available data, and did not know whether patients used or had an outpatient medical center near them after discharge. Furthermore, the study comprised older adults with fee-for-service Medicare and isn’t necessarily indicative of care for younger adults.

“Further investigation is warranted to better understand whether modifiable aspects of postdischarge care account for the remaining differences and whether interventions can be developed to eliminate racial disparities in care and survival for cardiac arrest survivors,” Dr. Chen and colleagues wrote.

This project was supported by a grant from the American Heart Association Young Investigator Research Seed. Dr. Chen received funding support from the Agency for Healthcare Research and Quality and the National Institute on Aging. Dr. Chen and another investigator received funding support from the National Heart, Lung, and Blood Institute.

SOURCE: Chen LM. Circulation. 2018 Jul 9. doi: 10.1161/circulationaha.117.033211.

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Key clinical point: Older black adults who had an in-hospital cardiac event had a lower chance of 1-year, 3-year, and 5-year survival post discharge, compared with white counterparts.

Major finding: Older black adults had a 28% lower relative risk of living at 1 year and a 33% lower relative risk of living at 5 years, compared with older white adults in the study.

Data source: A longitudinal study of 8,764 patients at least 65 years of age in the Get With The Guidelines–Resuscitation registry who were discharged after experiencing in-hospital cardiac arrest.

Disclosures: This project was supported by a grant from the American Heart Association Young Investigator Research Seed. Dr. Chen received funding support from the Agency for Healthcare Research and Quality and the National Institute on Aging. Dr. Chen and another investigator received funding support from the National Heart, Lung, and Blood Institute.

Source: Chen LM. Circulation. 2018 Jul 9. doi: 10.1161/circulationaha.117.033211.

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Opioid use of varying levels tied to physical, mental illnesses

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Adults who use opioids are more likely to have “complicated health profiles and high levels of involvement in the criminal justice system” compared with adults who do not, according to a retrospective, cross-sectional analysis published July 6 in JAMA Network Open.

“The large proportion of individuals with opioid use disorders who have physical and mental health conditions and who contact the criminal justice system suggests that public health interventions to combat the opioid epidemic ... should coordinate treatment between the criminal justice and health care systems,” wrote Tyler N.A. Winkelman, MD, and his colleagues.

The investigators evaluated a representative sample of responses from 78,976 U.S. adults aged 18-64 who completed the 2015-2016 National Survey on Drug Use and Health, of which 31.3% reported use of prescription opioids, 4.3% reported misuse of opioids, 0.8% reported abuse of prescription opioids, and 0.4% reported heroin use.

The researchers also studied the health characteristics of each individual based on their level of opioid use, whether individuals used other substances in addition to prescription opioids, and the respondents’ recent and distant involvement in the criminal justice system, reported Dr. Winkelman, who is affiliated with the division of general internal medicine at Hennepin Healthcare in Minneapolis, and his colleagues.

Dr. Tyler N.A. Winkelman

After adjustment for health characteristic prevalence and co-occurring substance use across opioid use levels, compared with individuals who reported no opioid use, Dr. Winkelman and his associates found a higher prevalence of mental illness among individuals across four categories: prescription opioid use, prescription opioid misuse, prescription opioid use disorder, and heroin use. They also found a higher prevalence of self-reported chronic conditions such as diabetes, asthma, and high blood pressure across various levels of opioid use, compared with people who reported no opioid use.

Furthermore, Dr. Winkelman and his associates found that as the intensity of opioid use increased, individuals reported an increased prevalence of mild, moderate, and severe mental illness. Individuals who increased their intensity of opioid use also had a greater likelihood of co-occurring substance use with at least one other substance. For example, individuals who misused opioids or used heroin reported that they used tranquilizers or sedatives in more than 50% of cases. Of individuals who reported heroin use, 88.5% said they used prescription opioids within the past year, reported Dr. Winkelman, also a staff physician at the Adult Detention Center in Hennepin County, Minn., and his associates.

The researchers also found 22.4% of individuals (95% confidence interval, 21.7-23.1) who used prescription opioids, 33.2% of individuals who misused prescription opioids (95% CI, 30.9-35.6), 51.7% of individuals with prescription opioid use disorder (95% CI, 45.4-58.0), and 76.8% of individuals with heroin use (95% CI, 70.6-82.1) had any contact with the criminal justice system, compared with 15.9% (95% CI, 15.4-16.4) of individuals who did not report prescription opioid use.

“The overlap we found between involvement in the criminal justice system and opioid use suggests that access to opioid treatment within the criminal justice system is a critical public health issue,” the researchers wrote. They cited studies showing that strategies such as beginning or continuing methadone hydrochloride or buprenorphine hydrochloride during incarceration are tied to a reduction in postrelease mortality.

Among the limitations cited were the National Survey on Drug Use and Health’s cross-sectional design, which makes it difficult to determine whether opioid use preceded involvement in the criminal justice system, or vice versa.

Nevertheless, they said, the study provides the most comprehensive picture to date of the status across several domains of people who use opioids.

“Given the complex health and criminal justice profiles of individuals who use opioids, policy makers should carefully consider how changes to public health insurance programs and sentencing guidelines may aid or hinder a public health approach to the opioid epidemic,” wrote Dr. Winkelman and his colleagues.

Dr. Winkelman disclosed his affiliation with the Hennepin County detention center. Another author disclosed employment with the Colorado Permanente Medical Group and royalties from uptodate.com.

SOURCE: Winkelman TNA et al. JAMA Network Open. 2018 Jul 6. doi: 10.1001/jamanetworkopen.2018.0558.

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Adults who use opioids are more likely to have “complicated health profiles and high levels of involvement in the criminal justice system” compared with adults who do not, according to a retrospective, cross-sectional analysis published July 6 in JAMA Network Open.

“The large proportion of individuals with opioid use disorders who have physical and mental health conditions and who contact the criminal justice system suggests that public health interventions to combat the opioid epidemic ... should coordinate treatment between the criminal justice and health care systems,” wrote Tyler N.A. Winkelman, MD, and his colleagues.

The investigators evaluated a representative sample of responses from 78,976 U.S. adults aged 18-64 who completed the 2015-2016 National Survey on Drug Use and Health, of which 31.3% reported use of prescription opioids, 4.3% reported misuse of opioids, 0.8% reported abuse of prescription opioids, and 0.4% reported heroin use.

The researchers also studied the health characteristics of each individual based on their level of opioid use, whether individuals used other substances in addition to prescription opioids, and the respondents’ recent and distant involvement in the criminal justice system, reported Dr. Winkelman, who is affiliated with the division of general internal medicine at Hennepin Healthcare in Minneapolis, and his colleagues.

Dr. Tyler N.A. Winkelman

After adjustment for health characteristic prevalence and co-occurring substance use across opioid use levels, compared with individuals who reported no opioid use, Dr. Winkelman and his associates found a higher prevalence of mental illness among individuals across four categories: prescription opioid use, prescription opioid misuse, prescription opioid use disorder, and heroin use. They also found a higher prevalence of self-reported chronic conditions such as diabetes, asthma, and high blood pressure across various levels of opioid use, compared with people who reported no opioid use.

Furthermore, Dr. Winkelman and his associates found that as the intensity of opioid use increased, individuals reported an increased prevalence of mild, moderate, and severe mental illness. Individuals who increased their intensity of opioid use also had a greater likelihood of co-occurring substance use with at least one other substance. For example, individuals who misused opioids or used heroin reported that they used tranquilizers or sedatives in more than 50% of cases. Of individuals who reported heroin use, 88.5% said they used prescription opioids within the past year, reported Dr. Winkelman, also a staff physician at the Adult Detention Center in Hennepin County, Minn., and his associates.

The researchers also found 22.4% of individuals (95% confidence interval, 21.7-23.1) who used prescription opioids, 33.2% of individuals who misused prescription opioids (95% CI, 30.9-35.6), 51.7% of individuals with prescription opioid use disorder (95% CI, 45.4-58.0), and 76.8% of individuals with heroin use (95% CI, 70.6-82.1) had any contact with the criminal justice system, compared with 15.9% (95% CI, 15.4-16.4) of individuals who did not report prescription opioid use.

“The overlap we found between involvement in the criminal justice system and opioid use suggests that access to opioid treatment within the criminal justice system is a critical public health issue,” the researchers wrote. They cited studies showing that strategies such as beginning or continuing methadone hydrochloride or buprenorphine hydrochloride during incarceration are tied to a reduction in postrelease mortality.

Among the limitations cited were the National Survey on Drug Use and Health’s cross-sectional design, which makes it difficult to determine whether opioid use preceded involvement in the criminal justice system, or vice versa.

Nevertheless, they said, the study provides the most comprehensive picture to date of the status across several domains of people who use opioids.

“Given the complex health and criminal justice profiles of individuals who use opioids, policy makers should carefully consider how changes to public health insurance programs and sentencing guidelines may aid or hinder a public health approach to the opioid epidemic,” wrote Dr. Winkelman and his colleagues.

Dr. Winkelman disclosed his affiliation with the Hennepin County detention center. Another author disclosed employment with the Colorado Permanente Medical Group and royalties from uptodate.com.

SOURCE: Winkelman TNA et al. JAMA Network Open. 2018 Jul 6. doi: 10.1001/jamanetworkopen.2018.0558.

 

Adults who use opioids are more likely to have “complicated health profiles and high levels of involvement in the criminal justice system” compared with adults who do not, according to a retrospective, cross-sectional analysis published July 6 in JAMA Network Open.

“The large proportion of individuals with opioid use disorders who have physical and mental health conditions and who contact the criminal justice system suggests that public health interventions to combat the opioid epidemic ... should coordinate treatment between the criminal justice and health care systems,” wrote Tyler N.A. Winkelman, MD, and his colleagues.

The investigators evaluated a representative sample of responses from 78,976 U.S. adults aged 18-64 who completed the 2015-2016 National Survey on Drug Use and Health, of which 31.3% reported use of prescription opioids, 4.3% reported misuse of opioids, 0.8% reported abuse of prescription opioids, and 0.4% reported heroin use.

The researchers also studied the health characteristics of each individual based on their level of opioid use, whether individuals used other substances in addition to prescription opioids, and the respondents’ recent and distant involvement in the criminal justice system, reported Dr. Winkelman, who is affiliated with the division of general internal medicine at Hennepin Healthcare in Minneapolis, and his colleagues.

Dr. Tyler N.A. Winkelman

After adjustment for health characteristic prevalence and co-occurring substance use across opioid use levels, compared with individuals who reported no opioid use, Dr. Winkelman and his associates found a higher prevalence of mental illness among individuals across four categories: prescription opioid use, prescription opioid misuse, prescription opioid use disorder, and heroin use. They also found a higher prevalence of self-reported chronic conditions such as diabetes, asthma, and high blood pressure across various levels of opioid use, compared with people who reported no opioid use.

Furthermore, Dr. Winkelman and his associates found that as the intensity of opioid use increased, individuals reported an increased prevalence of mild, moderate, and severe mental illness. Individuals who increased their intensity of opioid use also had a greater likelihood of co-occurring substance use with at least one other substance. For example, individuals who misused opioids or used heroin reported that they used tranquilizers or sedatives in more than 50% of cases. Of individuals who reported heroin use, 88.5% said they used prescription opioids within the past year, reported Dr. Winkelman, also a staff physician at the Adult Detention Center in Hennepin County, Minn., and his associates.

The researchers also found 22.4% of individuals (95% confidence interval, 21.7-23.1) who used prescription opioids, 33.2% of individuals who misused prescription opioids (95% CI, 30.9-35.6), 51.7% of individuals with prescription opioid use disorder (95% CI, 45.4-58.0), and 76.8% of individuals with heroin use (95% CI, 70.6-82.1) had any contact with the criminal justice system, compared with 15.9% (95% CI, 15.4-16.4) of individuals who did not report prescription opioid use.

“The overlap we found between involvement in the criminal justice system and opioid use suggests that access to opioid treatment within the criminal justice system is a critical public health issue,” the researchers wrote. They cited studies showing that strategies such as beginning or continuing methadone hydrochloride or buprenorphine hydrochloride during incarceration are tied to a reduction in postrelease mortality.

Among the limitations cited were the National Survey on Drug Use and Health’s cross-sectional design, which makes it difficult to determine whether opioid use preceded involvement in the criminal justice system, or vice versa.

Nevertheless, they said, the study provides the most comprehensive picture to date of the status across several domains of people who use opioids.

“Given the complex health and criminal justice profiles of individuals who use opioids, policy makers should carefully consider how changes to public health insurance programs and sentencing guidelines may aid or hinder a public health approach to the opioid epidemic,” wrote Dr. Winkelman and his colleagues.

Dr. Winkelman disclosed his affiliation with the Hennepin County detention center. Another author disclosed employment with the Colorado Permanente Medical Group and royalties from uptodate.com.

SOURCE: Winkelman TNA et al. JAMA Network Open. 2018 Jul 6. doi: 10.1001/jamanetworkopen.2018.0558.

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Key clinical point: Users of prescription opioids were more likely to have physical and mental health conditions, co-occurring substance use, and a history in the criminal justice system.

Major finding: Among survey participants with opioid misuse and opioid use disorder, 22.4% and 33.3% reported having a history with the criminal justice system, and 76.8% of participants who reported heroin use said they had involvement with the criminal justice system.

Data source: A retrospective, cross-sectional analysis of 78,976 survey respondents aged 18-64 from the 2015-2016 National Survey on Drug Use and Health.

Disclosures: Dr. Winkelman is a staff physician at the Adult Detention Center in Hennepin County, Minn. Another author reported employment with the Colorado Permanente Medical Group and royalties from uptodate.com.

Source: Winkelman TNA et al. JAMA Network Open. 2018 Jul 6. doi: 10.1001/jamanetworkopen.2018.0558.

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Novel blood test that predicts gestational age, fetal development, could improve prenatal care

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Fri, 01/18/2019 - 17:44

 

Researchers have identified cell-free RNA transcripts obtained from a noninvasive blood test during pregnancy that can predict risk of preterm birth in addition to predicting gestational age with an accuracy similar to ultrasound, which may soon pave the way for a low-cost alternative to ultrasound for prenatal care in developing areas, according to recent results from two pilot studies.

“Our results are thus generally comparable to ultrasound measurements, can be performed throughout pregnancy, and do not require a priori physiological knowledge such as the woman’s last menstrual period,” Stephen Quake, PhD, of Stanford (Calif.) University, and his colleagues wrote in Science.

Dr. Quake and his colleagues recruited 31 women from Denmark who provided weekly blood samples (521 samples) during pregnancy up until they delivered full-term. After analyzing the cell-free RNA (cfRNA) genes, researchers found cfRNA placenta, fetal, and immune genes were highly correlated with one another. They created a random forest model based on nine cfRNA genes (CGA, CAPN6, CGB, ALPP, CSHL1, PLAC4, PSG7, PAPPA, and LGALS14) that corresponded with the placenta. They estimated that those nine genes would predict gestational age and tested the model using 306 samples from 21 women in a training cohort and validated the test using 215 samples from 10 women in a validation cohort. The blood test predicted gestational age within 14 days of delivery in 32% of cases at the second trimester (T2), 23% at the third trimester (3T), and 45% at T2 and T3, compared with a 48% with ultrasound.

In a second pilot study, Dr. Quake and his colleagues created a polymerase chain reaction panel for 38 genes identified from sequencing RNA from patients in Pennsylvania, Alabama, and Denmark, with full-term and preterm deliveries up to 2 months before labor to determine “cfRNA transcripts that might be able to discriminate a spontaneous preterm delivery from a full-term delivery.” The top seven cfRNA transcripts (CLCN3, DAPP1, PPBP, MAP3K7CL, MOB1B, RAB27B, and RGS18), when grouped in “unique combinations” of three genes, predicted 75% of preterm samples and misclassified 1 of 26 samples (4%) from Denmark and Pennsylvania; in a validated cohort of Alabama patients, the test predicted 4 of 5 preterm samples (80%) and misclassified 3 of 18 full-term samples (17%).

“These cfRNA [polymerase chain reaction]–based tests have two advantages over alternatives: broader applicability and lower cost,” Dr. Quake and his colleagues wrote. “They can be applied across the globe as a complement to or substitute for ultrasound, which can be expensive and inaccurate during the second and third trimesters.”

The authors noted a larger sample size and blinded testing on a broader patient population is needed before clinics can apply this blood test in a diagnostic or screening tool for widespread use.

Dr. Quake and three other authors have a patent application submitted by the Chan Zuckerberg Biohub relating to “noninvasive estimates of gestational age, delivery, and preterm birth.” The other authors have no relevant financial disclosures.

SOURCE: Ngo TTM et al. Science. 2018 Jun 7. doi: 10.1126/science.aar3819.

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Researchers have identified cell-free RNA transcripts obtained from a noninvasive blood test during pregnancy that can predict risk of preterm birth in addition to predicting gestational age with an accuracy similar to ultrasound, which may soon pave the way for a low-cost alternative to ultrasound for prenatal care in developing areas, according to recent results from two pilot studies.

“Our results are thus generally comparable to ultrasound measurements, can be performed throughout pregnancy, and do not require a priori physiological knowledge such as the woman’s last menstrual period,” Stephen Quake, PhD, of Stanford (Calif.) University, and his colleagues wrote in Science.

Dr. Quake and his colleagues recruited 31 women from Denmark who provided weekly blood samples (521 samples) during pregnancy up until they delivered full-term. After analyzing the cell-free RNA (cfRNA) genes, researchers found cfRNA placenta, fetal, and immune genes were highly correlated with one another. They created a random forest model based on nine cfRNA genes (CGA, CAPN6, CGB, ALPP, CSHL1, PLAC4, PSG7, PAPPA, and LGALS14) that corresponded with the placenta. They estimated that those nine genes would predict gestational age and tested the model using 306 samples from 21 women in a training cohort and validated the test using 215 samples from 10 women in a validation cohort. The blood test predicted gestational age within 14 days of delivery in 32% of cases at the second trimester (T2), 23% at the third trimester (3T), and 45% at T2 and T3, compared with a 48% with ultrasound.

In a second pilot study, Dr. Quake and his colleagues created a polymerase chain reaction panel for 38 genes identified from sequencing RNA from patients in Pennsylvania, Alabama, and Denmark, with full-term and preterm deliveries up to 2 months before labor to determine “cfRNA transcripts that might be able to discriminate a spontaneous preterm delivery from a full-term delivery.” The top seven cfRNA transcripts (CLCN3, DAPP1, PPBP, MAP3K7CL, MOB1B, RAB27B, and RGS18), when grouped in “unique combinations” of three genes, predicted 75% of preterm samples and misclassified 1 of 26 samples (4%) from Denmark and Pennsylvania; in a validated cohort of Alabama patients, the test predicted 4 of 5 preterm samples (80%) and misclassified 3 of 18 full-term samples (17%).

“These cfRNA [polymerase chain reaction]–based tests have two advantages over alternatives: broader applicability and lower cost,” Dr. Quake and his colleagues wrote. “They can be applied across the globe as a complement to or substitute for ultrasound, which can be expensive and inaccurate during the second and third trimesters.”

The authors noted a larger sample size and blinded testing on a broader patient population is needed before clinics can apply this blood test in a diagnostic or screening tool for widespread use.

Dr. Quake and three other authors have a patent application submitted by the Chan Zuckerberg Biohub relating to “noninvasive estimates of gestational age, delivery, and preterm birth.” The other authors have no relevant financial disclosures.

SOURCE: Ngo TTM et al. Science. 2018 Jun 7. doi: 10.1126/science.aar3819.

 

Researchers have identified cell-free RNA transcripts obtained from a noninvasive blood test during pregnancy that can predict risk of preterm birth in addition to predicting gestational age with an accuracy similar to ultrasound, which may soon pave the way for a low-cost alternative to ultrasound for prenatal care in developing areas, according to recent results from two pilot studies.

“Our results are thus generally comparable to ultrasound measurements, can be performed throughout pregnancy, and do not require a priori physiological knowledge such as the woman’s last menstrual period,” Stephen Quake, PhD, of Stanford (Calif.) University, and his colleagues wrote in Science.

Dr. Quake and his colleagues recruited 31 women from Denmark who provided weekly blood samples (521 samples) during pregnancy up until they delivered full-term. After analyzing the cell-free RNA (cfRNA) genes, researchers found cfRNA placenta, fetal, and immune genes were highly correlated with one another. They created a random forest model based on nine cfRNA genes (CGA, CAPN6, CGB, ALPP, CSHL1, PLAC4, PSG7, PAPPA, and LGALS14) that corresponded with the placenta. They estimated that those nine genes would predict gestational age and tested the model using 306 samples from 21 women in a training cohort and validated the test using 215 samples from 10 women in a validation cohort. The blood test predicted gestational age within 14 days of delivery in 32% of cases at the second trimester (T2), 23% at the third trimester (3T), and 45% at T2 and T3, compared with a 48% with ultrasound.

In a second pilot study, Dr. Quake and his colleagues created a polymerase chain reaction panel for 38 genes identified from sequencing RNA from patients in Pennsylvania, Alabama, and Denmark, with full-term and preterm deliveries up to 2 months before labor to determine “cfRNA transcripts that might be able to discriminate a spontaneous preterm delivery from a full-term delivery.” The top seven cfRNA transcripts (CLCN3, DAPP1, PPBP, MAP3K7CL, MOB1B, RAB27B, and RGS18), when grouped in “unique combinations” of three genes, predicted 75% of preterm samples and misclassified 1 of 26 samples (4%) from Denmark and Pennsylvania; in a validated cohort of Alabama patients, the test predicted 4 of 5 preterm samples (80%) and misclassified 3 of 18 full-term samples (17%).

“These cfRNA [polymerase chain reaction]–based tests have two advantages over alternatives: broader applicability and lower cost,” Dr. Quake and his colleagues wrote. “They can be applied across the globe as a complement to or substitute for ultrasound, which can be expensive and inaccurate during the second and third trimesters.”

The authors noted a larger sample size and blinded testing on a broader patient population is needed before clinics can apply this blood test in a diagnostic or screening tool for widespread use.

Dr. Quake and three other authors have a patent application submitted by the Chan Zuckerberg Biohub relating to “noninvasive estimates of gestational age, delivery, and preterm birth.” The other authors have no relevant financial disclosures.

SOURCE: Ngo TTM et al. Science. 2018 Jun 7. doi: 10.1126/science.aar3819.

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Key clinical point: Cell-free RNA transcripts identified from a single blood sample can reliably predict gestational age similar to ultrasound and can identify risk of preterm birth.

Major finding: Nine cell-free RNA transcripts predicted gestational age at an accuracy similar to ultrasound, while seven cell-free RNA transcripts predicted an increased risk of preterm birth until 2 months prior to delivery.

Study details: A pilot study of 31 pregnant women and a related pilot study of 38 women with full-term or preterm deliveries.

Disclosures: Dr. Quake and three other authors have a patent application submitted by the Chan Zuckerberg Biohub relating to “noninvasive estimates of gestational age, delivery, and preterm birth.” The other authors have no relevant financial disclosures.

Source: Ngo TTM et al. Science. 2018 Jun 7. doi: 10.1126/science.aar3819.

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'Systemic changes' needed for bronchoscope disinfection

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Current guidelines for disinfecting bronchoscopes may not be adequate to prevent transmission of infection, as researchers found all reprocessed bronchoscopes they observed had residual contamination and over half showed microbial growth, according to results from a recent study in CHEST.

“Evidence-based, bronchoscope-specific reprocessing and maintenance guidelines are needed, along with quality management programs to ensure that these complex processes are carried out effectively,” Cori L. Ofstead, MSPH, president and CEO of Ofstead & Associates, and her colleagues wrote in their study. “Shifting toward using sterilized or single-use bronchoscopes could reduce the risk of infection transmission among vulnerable pulmonary patient populations.”

National Institute of Allergy and Infectious Diseases
Staphylococcus epidermidis

The researchers inspected 24 reprocessed bronchoscopes used clinically (9 pediatric, 9 therapeutic, 6 endobronchial ultrasound) at three U.S. tertiary care centers in 2017 and compared them with two bronchoscopes that had not been used. Of the bronchoscopes observed, all had residual contamination after manual cleaning and high-level disinfection (HLD). Manually cleaned bronchoscopes had microbial growth in 11 of 20 (55%) samples, while 14 of 24 (58%) of HLD samples contained microbial growth. Upon inspection, the researchers said they discovered “oily residue; dried fluid spots; brown, red, and white residue; scratches; insertion tube buckling; and damaged distal ends,” while internal inspections yielded “fluid, discoloration, scratches, filamentous debris, and dented channels.”

Ms. Ofstead and colleagues noted that, while the first site exceeded national guidelines, sites B and C contained technicians who did not wear personal protective equipment and the sites did not follow national or manufacturer use guidelines, such as passing bronchoscopes “through a window to a clean room for automated cleaning and HLD with peracetic acid in automated endoscope reprocessor,” flushing the bronchoscopes with alcohol, drying them with medical-grade forced air pressure, and storing them in a dedicated clean and dry area. Site A had microbial growth in 20% and 50% of manually cleaned and HLD bronchoscopes, respectively, site B had microbial growth in 100% and 75% of manually cleaned and HLD bronchoscopes, respectively, and site C had microbial growth in 83% and 50% of manually cleaned and HLD bronchoscopes, respectively. Among the microbial species identified were “environmental bacteria and normal flora” such as Bacillus spp and Staphylococcus epidermidis, molds such as Lecanicillium lecanii and Verticillium dahliae, and pathogens such as Stenotrophomonas maltophilia and Escherichia coli/Shigella spp.

“The clinical implications for patients are unknown as the study did not involve assessing patients or reviewing medical records,” Ms. Ofstead and her colleagues wrote. “However, the results are worrisome as patients undergoing bronchoscopy are commonly at high risk for infection due to transplant status, critical illness, or immune suppression due to malignancy or chronic disease.”

Ms. Ofstead and three authors are employees of Ofstead & Associates, which received research funding and speaking honoraria from 3M, Advanced Sterilization Products (Johnson & Johnson), Ambu, Auris Health, Boston Scientific, Cogentix, ConvergAscent, Healthmark Industries, Invendo Medical, Medivators, Nanosonics, and STERIS. Dr. Ferguson has received fees from NeuWave Medical and PPD, research grants and personal fees from OncoCyte, and research grants from Concordia and PneumRx. Dr. Sonetti reported no relevant financial disclosures.

SOURCE: Ofstead CL et al. Chest. 2018 May 30. doi: 10.1016/j.chest.2018.04.045.

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Current guidelines for disinfecting bronchoscopes may not be adequate to prevent transmission of infection, as researchers found all reprocessed bronchoscopes they observed had residual contamination and over half showed microbial growth, according to results from a recent study in CHEST.

“Evidence-based, bronchoscope-specific reprocessing and maintenance guidelines are needed, along with quality management programs to ensure that these complex processes are carried out effectively,” Cori L. Ofstead, MSPH, president and CEO of Ofstead & Associates, and her colleagues wrote in their study. “Shifting toward using sterilized or single-use bronchoscopes could reduce the risk of infection transmission among vulnerable pulmonary patient populations.”

National Institute of Allergy and Infectious Diseases
Staphylococcus epidermidis

The researchers inspected 24 reprocessed bronchoscopes used clinically (9 pediatric, 9 therapeutic, 6 endobronchial ultrasound) at three U.S. tertiary care centers in 2017 and compared them with two bronchoscopes that had not been used. Of the bronchoscopes observed, all had residual contamination after manual cleaning and high-level disinfection (HLD). Manually cleaned bronchoscopes had microbial growth in 11 of 20 (55%) samples, while 14 of 24 (58%) of HLD samples contained microbial growth. Upon inspection, the researchers said they discovered “oily residue; dried fluid spots; brown, red, and white residue; scratches; insertion tube buckling; and damaged distal ends,” while internal inspections yielded “fluid, discoloration, scratches, filamentous debris, and dented channels.”

Ms. Ofstead and colleagues noted that, while the first site exceeded national guidelines, sites B and C contained technicians who did not wear personal protective equipment and the sites did not follow national or manufacturer use guidelines, such as passing bronchoscopes “through a window to a clean room for automated cleaning and HLD with peracetic acid in automated endoscope reprocessor,” flushing the bronchoscopes with alcohol, drying them with medical-grade forced air pressure, and storing them in a dedicated clean and dry area. Site A had microbial growth in 20% and 50% of manually cleaned and HLD bronchoscopes, respectively, site B had microbial growth in 100% and 75% of manually cleaned and HLD bronchoscopes, respectively, and site C had microbial growth in 83% and 50% of manually cleaned and HLD bronchoscopes, respectively. Among the microbial species identified were “environmental bacteria and normal flora” such as Bacillus spp and Staphylococcus epidermidis, molds such as Lecanicillium lecanii and Verticillium dahliae, and pathogens such as Stenotrophomonas maltophilia and Escherichia coli/Shigella spp.

“The clinical implications for patients are unknown as the study did not involve assessing patients or reviewing medical records,” Ms. Ofstead and her colleagues wrote. “However, the results are worrisome as patients undergoing bronchoscopy are commonly at high risk for infection due to transplant status, critical illness, or immune suppression due to malignancy or chronic disease.”

Ms. Ofstead and three authors are employees of Ofstead & Associates, which received research funding and speaking honoraria from 3M, Advanced Sterilization Products (Johnson & Johnson), Ambu, Auris Health, Boston Scientific, Cogentix, ConvergAscent, Healthmark Industries, Invendo Medical, Medivators, Nanosonics, and STERIS. Dr. Ferguson has received fees from NeuWave Medical and PPD, research grants and personal fees from OncoCyte, and research grants from Concordia and PneumRx. Dr. Sonetti reported no relevant financial disclosures.

SOURCE: Ofstead CL et al. Chest. 2018 May 30. doi: 10.1016/j.chest.2018.04.045.

 

Current guidelines for disinfecting bronchoscopes may not be adequate to prevent transmission of infection, as researchers found all reprocessed bronchoscopes they observed had residual contamination and over half showed microbial growth, according to results from a recent study in CHEST.

“Evidence-based, bronchoscope-specific reprocessing and maintenance guidelines are needed, along with quality management programs to ensure that these complex processes are carried out effectively,” Cori L. Ofstead, MSPH, president and CEO of Ofstead & Associates, and her colleagues wrote in their study. “Shifting toward using sterilized or single-use bronchoscopes could reduce the risk of infection transmission among vulnerable pulmonary patient populations.”

National Institute of Allergy and Infectious Diseases
Staphylococcus epidermidis

The researchers inspected 24 reprocessed bronchoscopes used clinically (9 pediatric, 9 therapeutic, 6 endobronchial ultrasound) at three U.S. tertiary care centers in 2017 and compared them with two bronchoscopes that had not been used. Of the bronchoscopes observed, all had residual contamination after manual cleaning and high-level disinfection (HLD). Manually cleaned bronchoscopes had microbial growth in 11 of 20 (55%) samples, while 14 of 24 (58%) of HLD samples contained microbial growth. Upon inspection, the researchers said they discovered “oily residue; dried fluid spots; brown, red, and white residue; scratches; insertion tube buckling; and damaged distal ends,” while internal inspections yielded “fluid, discoloration, scratches, filamentous debris, and dented channels.”

Ms. Ofstead and colleagues noted that, while the first site exceeded national guidelines, sites B and C contained technicians who did not wear personal protective equipment and the sites did not follow national or manufacturer use guidelines, such as passing bronchoscopes “through a window to a clean room for automated cleaning and HLD with peracetic acid in automated endoscope reprocessor,” flushing the bronchoscopes with alcohol, drying them with medical-grade forced air pressure, and storing them in a dedicated clean and dry area. Site A had microbial growth in 20% and 50% of manually cleaned and HLD bronchoscopes, respectively, site B had microbial growth in 100% and 75% of manually cleaned and HLD bronchoscopes, respectively, and site C had microbial growth in 83% and 50% of manually cleaned and HLD bronchoscopes, respectively. Among the microbial species identified were “environmental bacteria and normal flora” such as Bacillus spp and Staphylococcus epidermidis, molds such as Lecanicillium lecanii and Verticillium dahliae, and pathogens such as Stenotrophomonas maltophilia and Escherichia coli/Shigella spp.

“The clinical implications for patients are unknown as the study did not involve assessing patients or reviewing medical records,” Ms. Ofstead and her colleagues wrote. “However, the results are worrisome as patients undergoing bronchoscopy are commonly at high risk for infection due to transplant status, critical illness, or immune suppression due to malignancy or chronic disease.”

Ms. Ofstead and three authors are employees of Ofstead & Associates, which received research funding and speaking honoraria from 3M, Advanced Sterilization Products (Johnson & Johnson), Ambu, Auris Health, Boston Scientific, Cogentix, ConvergAscent, Healthmark Industries, Invendo Medical, Medivators, Nanosonics, and STERIS. Dr. Ferguson has received fees from NeuWave Medical and PPD, research grants and personal fees from OncoCyte, and research grants from Concordia and PneumRx. Dr. Sonetti reported no relevant financial disclosures.

SOURCE: Ofstead CL et al. Chest. 2018 May 30. doi: 10.1016/j.chest.2018.04.045.

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Key clinical point: Despite following disinfection guidelines, damaged or contaminated reprocessed bronchoscopes were being used at all study sites.

Major finding: All reprocessed bronchoscopes observed had residual contamination, while 58% that underwent high-level disinfection contained microbial growth.

Data source: A prospective study of 24 bronchoscopes from three large U.S. tertiary care hospitals in 2017.

Disclosures: Ms. Ofstead and three authors are employees of Ofstead & Associates, which received research funding and speaking honoraria from 3M, Advanced Sterilization Products (Johnson & Johnson), Ambu, Auris Health, Boston Scientific, Cogentix, ConvergAscent, Healthmark Industries, Invendo Medical, Medivators, Nanosonics, and STERIS. Dr. Ferguson has received fees from NeuWave Medical and PPD, research grants and personal fees from OncoCyte, and research grants from Concordia and PneumRx. Dr. Sonetti reported no relevant financial disclosures.

Source: Ofstead CL et al. Chest. 2018 May 30. doi: 10.1016/j.chest.2018.04.045.

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ASH urges lawmakers to keep opioids accessible

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Wed, 03/27/2019 - 11:43

 

The American Society of Hematology (ASH) has released a new policy statement in favor of safeguarding access to opioids for hematology patients with chronic, severe pain as policymakers consider restrictions on opioid prescribing.

The statement is a recognition from ASH officials of the large number of opioid overdose deaths that involve prescription medication, and an acknowledgment that hematologists need to be advocates for their patients, said Joseph Alvarnas, MD, of City of Hope, Duarte, Calif.

Courtesy of City of Hope
Dr. Joseph Alvarnas
“When encountering a complex issue like the opioid crisis, you have to be able to fully tackle the necessary complexity of managing patients [and] families through this epidemic,” Dr. Alvarnas said in an interview. “Part of that is having restrictions where appropriate, but also recognizing that amongst vulnerable patients, we don’t want to create undue barriers and, in the process, necessitate that patients suffer unnecessarily so.”

The scope of the opioid problem is significant and worsening. More than 200,000 people in the United States died from overdoses related to prescription opioids. And in 2016, about 46 people were dying every day from prescription opioid overdoses, according to the Centers for Disease Control and Prevention.

In October 2017, President Trump declared that the opioid crisis was a nationwide “public health emergency” and regulators with the Centers for Medicare % Medicaid Services have already put in place restrictions on opioid dosing through the Medicare Part D program.

In a rule finalized in April 2018, the CMS placed restrictions on the dosage of opioids available for chronic opioid users and limited the days’ supply for first-time opioid users. For chronic users, the CMS set a 90-morphine-milligram-equivalent (MME) per day limit that triggers pharmacist consultation with the prescriber. The agency instructed health plans to implement an “opioid care coordination edit” that would be triggered at 90 MME per day across all opioid prescriptions and would require pharmacists to contact prescribers to override for a higher dosage.

The entire exchange must be documented. The CMS instructed health plans in the Medicare Part D program to implement a “hard safety edit” that limits opioid prescription fills to no more than a 7-day supply for opioid-naive patients being treated for acute pain. The changes are set to take effect in January 2019.

 

 


But Diane E. Meier, MD, director of the Center to Advance Palliative Care in New York, said the most current data suggest the risk of addiction and substance use disorder among medically-ill patients taking opioids is less than 10%. “That means that 90% of patients with a serious medical illness can safely take opioids for the relief of pain that is causing functional disorder,” she said.

Policymakers should not conflate the use and prescription of opioids with cases of misuse and abuse, Dr. Alvarnas said. Some patients will require a higher dose of opioids depending on their age or number of pain episodes, or because of their body’s physiological response.

Dr. Ifeyinwa (Ify) Osunkwo
“No matter what the medicine is, they’re going to require a higher dose for future episodes of pain because of repeated exposure,” said Ifeyinwa Osunkwo, MD, MPH, a sickle cell disease specialist at Levine Cancer Institute in Charlotte, N.C., and a member of the Hematology News editorial advisory board.

Some policies, such as a prior authorization, create “artificial barriers and delays in getting access to medication” for these patients, Dr. Alvarnas said. “When you create a far more arduous prior [authorization] process or limit prescriptions ... if someone has a severe blood disorder or a bone cancer, then what you’re doing is setting up a system that will fail those patients on a regular basis,” he said.

 

 


Patients may also have difficulty finding pharmacies that dispense opioid medications, or doctors who will prescribe them, because of fear of repercussions from the Drug Enforcement Administration or their state licensing boards, Dr. Meier said.

No ‘one-size-fits-all’

Because treatment is individualized, there is no “one-size-fits-all” approach to pain management for patients with hematological diseases.

“One of the concerns is that we care for populations of patients, such as those with sickle cell disease, those with blood cancers that can cause destructive bony lesions like somebody with multiple myeloma might experience, or even pain associated with the complication of a disease like hemophilia, where [patients experience] excruciating pain ... from bleeding into a joint,” Dr. Alvarnas said.

It’s not enough to offer anti-inflammatory medications to these patients – and in some cases doing so may create additional problems, experts said. Contraindications for anti-inflammatory agents tend to be more significant in hematology patients because of low platelet counts, liver disease, and kidney disease. This may prevent them from taking medications such as ibuprofen, acetaminophen, or naproxen sodium. Opioids are the “only option” for patients with these kinds of complications who have severe pain, Dr. Osunkwo said.
 

 

 

Pain management training

While hematologists are trained about the potential risks of common drugs such as steroids, “none of that education and training has occurred” for opioids, Dr. Meier said.

Dr. Diane E. Meier
“In my view, that is a major contributor to both under- and overprescribing of opioids and has been a contributor to the crisis that our country is currently in the middle of,” she said.

Since hematologists often aren’t trained in pain management, many are uncomfortable with managing pain in their diagnosis and leave the responsibility to a pain specialist, Dr. Osunkwo said. “But the problem is, they know more about the disease than anybody else, and you’ll be safer if [they] are doing the pain management for hematology patients because they know the risk and benefit of the different drugs in light of the diagnosis itself, compared to passing that on to somebody else to manage.”

In the recent policy statement, ASH leaders committed to creating evidence-based guidelines and education activities on pain management.

 

 

Finding balance

ASH leaders recognize the longstanding, complex nature of the opioid epidemic and want to be a part of the conversation to ensure their patients’ needs and considerations are met in future legislation, Dr. Alvarnas noted.

Dr. Meier, who is vice chair for public policy at Icahn School of Medicine at Mount Sinai, New York, said the issue of balance is paramount when considering good policymaking.

“No policy at either extreme is the right policy,” Dr. Meier said. “Good policymaking, good public health interventions attempt to achieve some balance ... in preventing harm and maximizing appropriate treatment of vulnerable, seriously ill patients. And the policies we have now don’t achieve that.”

The “Statement on Opioid Use in Patients with Hematologic Diseases and Disorders” is available on the ASH website.

Dr. Alvarnas is chair of the society’s Committee on Practice. Dr. Meier and Dr. Osunkwo reported having no relevant financial disclosures.

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The American Society of Hematology (ASH) has released a new policy statement in favor of safeguarding access to opioids for hematology patients with chronic, severe pain as policymakers consider restrictions on opioid prescribing.

The statement is a recognition from ASH officials of the large number of opioid overdose deaths that involve prescription medication, and an acknowledgment that hematologists need to be advocates for their patients, said Joseph Alvarnas, MD, of City of Hope, Duarte, Calif.

Courtesy of City of Hope
Dr. Joseph Alvarnas
“When encountering a complex issue like the opioid crisis, you have to be able to fully tackle the necessary complexity of managing patients [and] families through this epidemic,” Dr. Alvarnas said in an interview. “Part of that is having restrictions where appropriate, but also recognizing that amongst vulnerable patients, we don’t want to create undue barriers and, in the process, necessitate that patients suffer unnecessarily so.”

The scope of the opioid problem is significant and worsening. More than 200,000 people in the United States died from overdoses related to prescription opioids. And in 2016, about 46 people were dying every day from prescription opioid overdoses, according to the Centers for Disease Control and Prevention.

In October 2017, President Trump declared that the opioid crisis was a nationwide “public health emergency” and regulators with the Centers for Medicare % Medicaid Services have already put in place restrictions on opioid dosing through the Medicare Part D program.

In a rule finalized in April 2018, the CMS placed restrictions on the dosage of opioids available for chronic opioid users and limited the days’ supply for first-time opioid users. For chronic users, the CMS set a 90-morphine-milligram-equivalent (MME) per day limit that triggers pharmacist consultation with the prescriber. The agency instructed health plans to implement an “opioid care coordination edit” that would be triggered at 90 MME per day across all opioid prescriptions and would require pharmacists to contact prescribers to override for a higher dosage.

The entire exchange must be documented. The CMS instructed health plans in the Medicare Part D program to implement a “hard safety edit” that limits opioid prescription fills to no more than a 7-day supply for opioid-naive patients being treated for acute pain. The changes are set to take effect in January 2019.

 

 


But Diane E. Meier, MD, director of the Center to Advance Palliative Care in New York, said the most current data suggest the risk of addiction and substance use disorder among medically-ill patients taking opioids is less than 10%. “That means that 90% of patients with a serious medical illness can safely take opioids for the relief of pain that is causing functional disorder,” she said.

Policymakers should not conflate the use and prescription of opioids with cases of misuse and abuse, Dr. Alvarnas said. Some patients will require a higher dose of opioids depending on their age or number of pain episodes, or because of their body’s physiological response.

Dr. Ifeyinwa (Ify) Osunkwo
“No matter what the medicine is, they’re going to require a higher dose for future episodes of pain because of repeated exposure,” said Ifeyinwa Osunkwo, MD, MPH, a sickle cell disease specialist at Levine Cancer Institute in Charlotte, N.C., and a member of the Hematology News editorial advisory board.

Some policies, such as a prior authorization, create “artificial barriers and delays in getting access to medication” for these patients, Dr. Alvarnas said. “When you create a far more arduous prior [authorization] process or limit prescriptions ... if someone has a severe blood disorder or a bone cancer, then what you’re doing is setting up a system that will fail those patients on a regular basis,” he said.

 

 


Patients may also have difficulty finding pharmacies that dispense opioid medications, or doctors who will prescribe them, because of fear of repercussions from the Drug Enforcement Administration or their state licensing boards, Dr. Meier said.

No ‘one-size-fits-all’

Because treatment is individualized, there is no “one-size-fits-all” approach to pain management for patients with hematological diseases.

“One of the concerns is that we care for populations of patients, such as those with sickle cell disease, those with blood cancers that can cause destructive bony lesions like somebody with multiple myeloma might experience, or even pain associated with the complication of a disease like hemophilia, where [patients experience] excruciating pain ... from bleeding into a joint,” Dr. Alvarnas said.

It’s not enough to offer anti-inflammatory medications to these patients – and in some cases doing so may create additional problems, experts said. Contraindications for anti-inflammatory agents tend to be more significant in hematology patients because of low platelet counts, liver disease, and kidney disease. This may prevent them from taking medications such as ibuprofen, acetaminophen, or naproxen sodium. Opioids are the “only option” for patients with these kinds of complications who have severe pain, Dr. Osunkwo said.
 

 

 

Pain management training

While hematologists are trained about the potential risks of common drugs such as steroids, “none of that education and training has occurred” for opioids, Dr. Meier said.

Dr. Diane E. Meier
“In my view, that is a major contributor to both under- and overprescribing of opioids and has been a contributor to the crisis that our country is currently in the middle of,” she said.

Since hematologists often aren’t trained in pain management, many are uncomfortable with managing pain in their diagnosis and leave the responsibility to a pain specialist, Dr. Osunkwo said. “But the problem is, they know more about the disease than anybody else, and you’ll be safer if [they] are doing the pain management for hematology patients because they know the risk and benefit of the different drugs in light of the diagnosis itself, compared to passing that on to somebody else to manage.”

In the recent policy statement, ASH leaders committed to creating evidence-based guidelines and education activities on pain management.

 

 

Finding balance

ASH leaders recognize the longstanding, complex nature of the opioid epidemic and want to be a part of the conversation to ensure their patients’ needs and considerations are met in future legislation, Dr. Alvarnas noted.

Dr. Meier, who is vice chair for public policy at Icahn School of Medicine at Mount Sinai, New York, said the issue of balance is paramount when considering good policymaking.

“No policy at either extreme is the right policy,” Dr. Meier said. “Good policymaking, good public health interventions attempt to achieve some balance ... in preventing harm and maximizing appropriate treatment of vulnerable, seriously ill patients. And the policies we have now don’t achieve that.”

The “Statement on Opioid Use in Patients with Hematologic Diseases and Disorders” is available on the ASH website.

Dr. Alvarnas is chair of the society’s Committee on Practice. Dr. Meier and Dr. Osunkwo reported having no relevant financial disclosures.

 

The American Society of Hematology (ASH) has released a new policy statement in favor of safeguarding access to opioids for hematology patients with chronic, severe pain as policymakers consider restrictions on opioid prescribing.

The statement is a recognition from ASH officials of the large number of opioid overdose deaths that involve prescription medication, and an acknowledgment that hematologists need to be advocates for their patients, said Joseph Alvarnas, MD, of City of Hope, Duarte, Calif.

Courtesy of City of Hope
Dr. Joseph Alvarnas
“When encountering a complex issue like the opioid crisis, you have to be able to fully tackle the necessary complexity of managing patients [and] families through this epidemic,” Dr. Alvarnas said in an interview. “Part of that is having restrictions where appropriate, but also recognizing that amongst vulnerable patients, we don’t want to create undue barriers and, in the process, necessitate that patients suffer unnecessarily so.”

The scope of the opioid problem is significant and worsening. More than 200,000 people in the United States died from overdoses related to prescription opioids. And in 2016, about 46 people were dying every day from prescription opioid overdoses, according to the Centers for Disease Control and Prevention.

In October 2017, President Trump declared that the opioid crisis was a nationwide “public health emergency” and regulators with the Centers for Medicare % Medicaid Services have already put in place restrictions on opioid dosing through the Medicare Part D program.

In a rule finalized in April 2018, the CMS placed restrictions on the dosage of opioids available for chronic opioid users and limited the days’ supply for first-time opioid users. For chronic users, the CMS set a 90-morphine-milligram-equivalent (MME) per day limit that triggers pharmacist consultation with the prescriber. The agency instructed health plans to implement an “opioid care coordination edit” that would be triggered at 90 MME per day across all opioid prescriptions and would require pharmacists to contact prescribers to override for a higher dosage.

The entire exchange must be documented. The CMS instructed health plans in the Medicare Part D program to implement a “hard safety edit” that limits opioid prescription fills to no more than a 7-day supply for opioid-naive patients being treated for acute pain. The changes are set to take effect in January 2019.

 

 


But Diane E. Meier, MD, director of the Center to Advance Palliative Care in New York, said the most current data suggest the risk of addiction and substance use disorder among medically-ill patients taking opioids is less than 10%. “That means that 90% of patients with a serious medical illness can safely take opioids for the relief of pain that is causing functional disorder,” she said.

Policymakers should not conflate the use and prescription of opioids with cases of misuse and abuse, Dr. Alvarnas said. Some patients will require a higher dose of opioids depending on their age or number of pain episodes, or because of their body’s physiological response.

Dr. Ifeyinwa (Ify) Osunkwo
“No matter what the medicine is, they’re going to require a higher dose for future episodes of pain because of repeated exposure,” said Ifeyinwa Osunkwo, MD, MPH, a sickle cell disease specialist at Levine Cancer Institute in Charlotte, N.C., and a member of the Hematology News editorial advisory board.

Some policies, such as a prior authorization, create “artificial barriers and delays in getting access to medication” for these patients, Dr. Alvarnas said. “When you create a far more arduous prior [authorization] process or limit prescriptions ... if someone has a severe blood disorder or a bone cancer, then what you’re doing is setting up a system that will fail those patients on a regular basis,” he said.

 

 


Patients may also have difficulty finding pharmacies that dispense opioid medications, or doctors who will prescribe them, because of fear of repercussions from the Drug Enforcement Administration or their state licensing boards, Dr. Meier said.

No ‘one-size-fits-all’

Because treatment is individualized, there is no “one-size-fits-all” approach to pain management for patients with hematological diseases.

“One of the concerns is that we care for populations of patients, such as those with sickle cell disease, those with blood cancers that can cause destructive bony lesions like somebody with multiple myeloma might experience, or even pain associated with the complication of a disease like hemophilia, where [patients experience] excruciating pain ... from bleeding into a joint,” Dr. Alvarnas said.

It’s not enough to offer anti-inflammatory medications to these patients – and in some cases doing so may create additional problems, experts said. Contraindications for anti-inflammatory agents tend to be more significant in hematology patients because of low platelet counts, liver disease, and kidney disease. This may prevent them from taking medications such as ibuprofen, acetaminophen, or naproxen sodium. Opioids are the “only option” for patients with these kinds of complications who have severe pain, Dr. Osunkwo said.
 

 

 

Pain management training

While hematologists are trained about the potential risks of common drugs such as steroids, “none of that education and training has occurred” for opioids, Dr. Meier said.

Dr. Diane E. Meier
“In my view, that is a major contributor to both under- and overprescribing of opioids and has been a contributor to the crisis that our country is currently in the middle of,” she said.

Since hematologists often aren’t trained in pain management, many are uncomfortable with managing pain in their diagnosis and leave the responsibility to a pain specialist, Dr. Osunkwo said. “But the problem is, they know more about the disease than anybody else, and you’ll be safer if [they] are doing the pain management for hematology patients because they know the risk and benefit of the different drugs in light of the diagnosis itself, compared to passing that on to somebody else to manage.”

In the recent policy statement, ASH leaders committed to creating evidence-based guidelines and education activities on pain management.

 

 

Finding balance

ASH leaders recognize the longstanding, complex nature of the opioid epidemic and want to be a part of the conversation to ensure their patients’ needs and considerations are met in future legislation, Dr. Alvarnas noted.

Dr. Meier, who is vice chair for public policy at Icahn School of Medicine at Mount Sinai, New York, said the issue of balance is paramount when considering good policymaking.

“No policy at either extreme is the right policy,” Dr. Meier said. “Good policymaking, good public health interventions attempt to achieve some balance ... in preventing harm and maximizing appropriate treatment of vulnerable, seriously ill patients. And the policies we have now don’t achieve that.”

The “Statement on Opioid Use in Patients with Hematologic Diseases and Disorders” is available on the ASH website.

Dr. Alvarnas is chair of the society’s Committee on Practice. Dr. Meier and Dr. Osunkwo reported having no relevant financial disclosures.

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Annual ob.gyn. visit a ‘powerful opportunity’ to talk heart health

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Thu, 03/28/2019 - 14:37

 

Clinicians in the cardiology, obstetrics, and gynecology specialties should collaborate and use a woman’s annual visit to her ob.gyn. to promote healthy lifestyle choices, screen for signs of cardiovascular disease and risk factors, and improve her overall cardiovascular health, according to a joint advisory released by the presidents of the American Heart Association and the American College of Obstetricians and Gynecologists.

“Ob.gyns. are primary care providers for many women, and the annual ‘well woman’ visit provides a powerful opportunity to counsel patients about achieving and maintaining a heart-healthy lifestyle, which is a cornerstone of maintaining heart health,” John Warner, MD, president of the AHA and executive vice president for Health System Affairs at University of Texas Southwestern Medical Center in Dallas, said in a press release.

javi_indy/ Thinkstock
The advisory noted that, because 90% of women have at least one modifiable risk factor for heart disease and a majority of women use their ob.gyn. as a primary care provider, clinicians in the obstetrics and gynecology fields can help identify traditional, nontraditional, and gender-specific cardiovascular risk factors in women during their annual well visits. Specifically, a woman’s risk for cardiovascular mortality is 20.9%, compared with 14.9% in men; men also are more likely to have adequate blood pressure management (41%) than are women (29%) after age 65 years. Cardiovascular risk associated with diabetes mellitus is also higher in women (19.1%), compared with men (10.1%), with diabetic women receiving less treatment for cardiovascular risk factors. At 47%, hypercholesterolemia is the “highest population-adjusted cardiovascular risk factor for women,” while obesity carries cardiovascular risks of physical inactivity, hypertension, insulin resistance, and dyslipidemia. The risk of cardiovascular complications is 25% higher for women who smoke than for men who smoke, and women who smoke and take oral contraceptives are at an increased risk of stroke.

“Traditional atherosclerotic cardiovascular disease (ASCVD) risk factors, such as hypertension, diabetes mellitus, hypercholesterolemia, and obesity, affect both sexes, but some may affect women differently and are considered to be more potent,” the authors wrote in their advisory.

The advisory also stated clinicians should be aware of ASCVD risk factors that are not specific to but are more prevalent in women, such as systemic lupus erythematosus, scleroderma, and rheumatoid arthritis.

“These disorders are highly prevalent among women who have an increased risk of coronary artery disease and other cardiovascular disease,” the authors wrote.

Gender-specific ASCVD risk factors for women include pregnancy complications such as gestational diabetes mellitus and low birth weight as estimated during gestation. Hypertension during gestation and preeclampsia carries a threefold to sixfold increased risk for subsequent hypertension while also carrying a twofold increased risk of stroke and ischemic heart disease. Non–pregnancy related risk factors included menopausal status, hormone use, polycystic ovarian syndrome, and functional hypothalamic amenorrhea.

 

 


“Pregnancy is essentially a ‘stress test’ for women, and these adverse pregnancy outcomes can be used to identify women who are at an increased risk for ASCVD, even in those for whom the conditions resolve after delivery,” the authors said.

To reduce or prevent these issues, the authors recommended ob.gyn. clinicians perform a “thorough family history, screening for and targeted review of cardiovascular risk factors (including those unique to women), and lifestyle counseling to improve cardiovascular risk factors with the goal of preventing future cardiovascular events.”

“The American College of Cardiology/American Heart Association guidelines for the assessment of cardiovascular risk find it reasonable to screen adults free of cardiovascular disease for risk factors such as smoking, hypertension, diabetes mellitus, total cholesterol, and high-density lipoprotein cholesterol every 4-6 years between the ages of 20 and 79 years to calculate their 10-year cardiovascular risk,” they wrote.

Regarding diabetes care, clinicians should screen for abnormal glucose levels in overweight or obese patients aged between 40 and 70 years and schedule lifestyle counseling for any patients with prediabetes (HbA1c = 5.7%-6.4%), diabetes mellitus (HbA1c greater than 6.4%), gestational diabetes, or metabolic syndrome.

 

 


Cholesterol and other traditional risk factors associated with hyperlipidemia should be checked every 4-6 years and patients with elevated lipids should receive counseling on lowering their saturated fat intake and adding more dietary fiber. Statins are also an option for patients where diet does not lower lipids to appropriate levels, but authors noted “women of childbearing age need to be specifically counseled to not become pregnant while taking a statin.” The advisory also recommended speaking with patients about engaging in “150 min/wk of moderate-intensity physical activity, 75 min/wk of vigorous-intensity aerobic physical activity, or an equivalent combination of moderate- and vigorous-intensity aerobic physical activity” as well as offering counseling and options for women who want to quit smoking.

The authors noted that only 45% of women consider heart disease a “leading cause of death” and most primary care providers do not see cardiovascular disease as a top health concern for women, focusing on risk factors such as weight and breast health.

“As the leading health care providers for women, ob.gyns. provide care that goes far beyond reproductive health and are in a unique position to screen, counsel, and educate patients on heart health. By acknowledging and discussing the risks and communicating steps women can take to reduce their odds of developing heart disease, ob.gyns. have a powerful opportunity to be the secret weapon in the fight against heart disease,” Haywood L. Brown, MD, past president of the ACOG and F. Bayard Carter Professor in the department of obstetrics and gynecology at Duke University, Durham, N.C., said in a press release.

Dr. Gianos is a consultant and/or on the advisory board for Regeneron. Dr. Wenger reports research grants from Gilead Sciences, the National Heart, Lung, and Blood Institute, Pfizer, and the Society for Women’s Health Research and is a consultant and/or on the advisory board for Amgen, AstraZeneca, Gilead Sciences, Janssen, and Merck.

SOURCE: Brown HL et al. Circulation. 2018 May 10. doi: 10.1161/CIR.0000000000000582.

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Clinicians in the cardiology, obstetrics, and gynecology specialties should collaborate and use a woman’s annual visit to her ob.gyn. to promote healthy lifestyle choices, screen for signs of cardiovascular disease and risk factors, and improve her overall cardiovascular health, according to a joint advisory released by the presidents of the American Heart Association and the American College of Obstetricians and Gynecologists.

“Ob.gyns. are primary care providers for many women, and the annual ‘well woman’ visit provides a powerful opportunity to counsel patients about achieving and maintaining a heart-healthy lifestyle, which is a cornerstone of maintaining heart health,” John Warner, MD, president of the AHA and executive vice president for Health System Affairs at University of Texas Southwestern Medical Center in Dallas, said in a press release.

javi_indy/ Thinkstock
The advisory noted that, because 90% of women have at least one modifiable risk factor for heart disease and a majority of women use their ob.gyn. as a primary care provider, clinicians in the obstetrics and gynecology fields can help identify traditional, nontraditional, and gender-specific cardiovascular risk factors in women during their annual well visits. Specifically, a woman’s risk for cardiovascular mortality is 20.9%, compared with 14.9% in men; men also are more likely to have adequate blood pressure management (41%) than are women (29%) after age 65 years. Cardiovascular risk associated with diabetes mellitus is also higher in women (19.1%), compared with men (10.1%), with diabetic women receiving less treatment for cardiovascular risk factors. At 47%, hypercholesterolemia is the “highest population-adjusted cardiovascular risk factor for women,” while obesity carries cardiovascular risks of physical inactivity, hypertension, insulin resistance, and dyslipidemia. The risk of cardiovascular complications is 25% higher for women who smoke than for men who smoke, and women who smoke and take oral contraceptives are at an increased risk of stroke.

“Traditional atherosclerotic cardiovascular disease (ASCVD) risk factors, such as hypertension, diabetes mellitus, hypercholesterolemia, and obesity, affect both sexes, but some may affect women differently and are considered to be more potent,” the authors wrote in their advisory.

The advisory also stated clinicians should be aware of ASCVD risk factors that are not specific to but are more prevalent in women, such as systemic lupus erythematosus, scleroderma, and rheumatoid arthritis.

“These disorders are highly prevalent among women who have an increased risk of coronary artery disease and other cardiovascular disease,” the authors wrote.

Gender-specific ASCVD risk factors for women include pregnancy complications such as gestational diabetes mellitus and low birth weight as estimated during gestation. Hypertension during gestation and preeclampsia carries a threefold to sixfold increased risk for subsequent hypertension while also carrying a twofold increased risk of stroke and ischemic heart disease. Non–pregnancy related risk factors included menopausal status, hormone use, polycystic ovarian syndrome, and functional hypothalamic amenorrhea.

 

 


“Pregnancy is essentially a ‘stress test’ for women, and these adverse pregnancy outcomes can be used to identify women who are at an increased risk for ASCVD, even in those for whom the conditions resolve after delivery,” the authors said.

To reduce or prevent these issues, the authors recommended ob.gyn. clinicians perform a “thorough family history, screening for and targeted review of cardiovascular risk factors (including those unique to women), and lifestyle counseling to improve cardiovascular risk factors with the goal of preventing future cardiovascular events.”

“The American College of Cardiology/American Heart Association guidelines for the assessment of cardiovascular risk find it reasonable to screen adults free of cardiovascular disease for risk factors such as smoking, hypertension, diabetes mellitus, total cholesterol, and high-density lipoprotein cholesterol every 4-6 years between the ages of 20 and 79 years to calculate their 10-year cardiovascular risk,” they wrote.

Regarding diabetes care, clinicians should screen for abnormal glucose levels in overweight or obese patients aged between 40 and 70 years and schedule lifestyle counseling for any patients with prediabetes (HbA1c = 5.7%-6.4%), diabetes mellitus (HbA1c greater than 6.4%), gestational diabetes, or metabolic syndrome.

 

 


Cholesterol and other traditional risk factors associated with hyperlipidemia should be checked every 4-6 years and patients with elevated lipids should receive counseling on lowering their saturated fat intake and adding more dietary fiber. Statins are also an option for patients where diet does not lower lipids to appropriate levels, but authors noted “women of childbearing age need to be specifically counseled to not become pregnant while taking a statin.” The advisory also recommended speaking with patients about engaging in “150 min/wk of moderate-intensity physical activity, 75 min/wk of vigorous-intensity aerobic physical activity, or an equivalent combination of moderate- and vigorous-intensity aerobic physical activity” as well as offering counseling and options for women who want to quit smoking.

The authors noted that only 45% of women consider heart disease a “leading cause of death” and most primary care providers do not see cardiovascular disease as a top health concern for women, focusing on risk factors such as weight and breast health.

“As the leading health care providers for women, ob.gyns. provide care that goes far beyond reproductive health and are in a unique position to screen, counsel, and educate patients on heart health. By acknowledging and discussing the risks and communicating steps women can take to reduce their odds of developing heart disease, ob.gyns. have a powerful opportunity to be the secret weapon in the fight against heart disease,” Haywood L. Brown, MD, past president of the ACOG and F. Bayard Carter Professor in the department of obstetrics and gynecology at Duke University, Durham, N.C., said in a press release.

Dr. Gianos is a consultant and/or on the advisory board for Regeneron. Dr. Wenger reports research grants from Gilead Sciences, the National Heart, Lung, and Blood Institute, Pfizer, and the Society for Women’s Health Research and is a consultant and/or on the advisory board for Amgen, AstraZeneca, Gilead Sciences, Janssen, and Merck.

SOURCE: Brown HL et al. Circulation. 2018 May 10. doi: 10.1161/CIR.0000000000000582.

 

Clinicians in the cardiology, obstetrics, and gynecology specialties should collaborate and use a woman’s annual visit to her ob.gyn. to promote healthy lifestyle choices, screen for signs of cardiovascular disease and risk factors, and improve her overall cardiovascular health, according to a joint advisory released by the presidents of the American Heart Association and the American College of Obstetricians and Gynecologists.

“Ob.gyns. are primary care providers for many women, and the annual ‘well woman’ visit provides a powerful opportunity to counsel patients about achieving and maintaining a heart-healthy lifestyle, which is a cornerstone of maintaining heart health,” John Warner, MD, president of the AHA and executive vice president for Health System Affairs at University of Texas Southwestern Medical Center in Dallas, said in a press release.

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The advisory noted that, because 90% of women have at least one modifiable risk factor for heart disease and a majority of women use their ob.gyn. as a primary care provider, clinicians in the obstetrics and gynecology fields can help identify traditional, nontraditional, and gender-specific cardiovascular risk factors in women during their annual well visits. Specifically, a woman’s risk for cardiovascular mortality is 20.9%, compared with 14.9% in men; men also are more likely to have adequate blood pressure management (41%) than are women (29%) after age 65 years. Cardiovascular risk associated with diabetes mellitus is also higher in women (19.1%), compared with men (10.1%), with diabetic women receiving less treatment for cardiovascular risk factors. At 47%, hypercholesterolemia is the “highest population-adjusted cardiovascular risk factor for women,” while obesity carries cardiovascular risks of physical inactivity, hypertension, insulin resistance, and dyslipidemia. The risk of cardiovascular complications is 25% higher for women who smoke than for men who smoke, and women who smoke and take oral contraceptives are at an increased risk of stroke.

“Traditional atherosclerotic cardiovascular disease (ASCVD) risk factors, such as hypertension, diabetes mellitus, hypercholesterolemia, and obesity, affect both sexes, but some may affect women differently and are considered to be more potent,” the authors wrote in their advisory.

The advisory also stated clinicians should be aware of ASCVD risk factors that are not specific to but are more prevalent in women, such as systemic lupus erythematosus, scleroderma, and rheumatoid arthritis.

“These disorders are highly prevalent among women who have an increased risk of coronary artery disease and other cardiovascular disease,” the authors wrote.

Gender-specific ASCVD risk factors for women include pregnancy complications such as gestational diabetes mellitus and low birth weight as estimated during gestation. Hypertension during gestation and preeclampsia carries a threefold to sixfold increased risk for subsequent hypertension while also carrying a twofold increased risk of stroke and ischemic heart disease. Non–pregnancy related risk factors included menopausal status, hormone use, polycystic ovarian syndrome, and functional hypothalamic amenorrhea.

 

 


“Pregnancy is essentially a ‘stress test’ for women, and these adverse pregnancy outcomes can be used to identify women who are at an increased risk for ASCVD, even in those for whom the conditions resolve after delivery,” the authors said.

To reduce or prevent these issues, the authors recommended ob.gyn. clinicians perform a “thorough family history, screening for and targeted review of cardiovascular risk factors (including those unique to women), and lifestyle counseling to improve cardiovascular risk factors with the goal of preventing future cardiovascular events.”

“The American College of Cardiology/American Heart Association guidelines for the assessment of cardiovascular risk find it reasonable to screen adults free of cardiovascular disease for risk factors such as smoking, hypertension, diabetes mellitus, total cholesterol, and high-density lipoprotein cholesterol every 4-6 years between the ages of 20 and 79 years to calculate their 10-year cardiovascular risk,” they wrote.

Regarding diabetes care, clinicians should screen for abnormal glucose levels in overweight or obese patients aged between 40 and 70 years and schedule lifestyle counseling for any patients with prediabetes (HbA1c = 5.7%-6.4%), diabetes mellitus (HbA1c greater than 6.4%), gestational diabetes, or metabolic syndrome.

 

 


Cholesterol and other traditional risk factors associated with hyperlipidemia should be checked every 4-6 years and patients with elevated lipids should receive counseling on lowering their saturated fat intake and adding more dietary fiber. Statins are also an option for patients where diet does not lower lipids to appropriate levels, but authors noted “women of childbearing age need to be specifically counseled to not become pregnant while taking a statin.” The advisory also recommended speaking with patients about engaging in “150 min/wk of moderate-intensity physical activity, 75 min/wk of vigorous-intensity aerobic physical activity, or an equivalent combination of moderate- and vigorous-intensity aerobic physical activity” as well as offering counseling and options for women who want to quit smoking.

The authors noted that only 45% of women consider heart disease a “leading cause of death” and most primary care providers do not see cardiovascular disease as a top health concern for women, focusing on risk factors such as weight and breast health.

“As the leading health care providers for women, ob.gyns. provide care that goes far beyond reproductive health and are in a unique position to screen, counsel, and educate patients on heart health. By acknowledging and discussing the risks and communicating steps women can take to reduce their odds of developing heart disease, ob.gyns. have a powerful opportunity to be the secret weapon in the fight against heart disease,” Haywood L. Brown, MD, past president of the ACOG and F. Bayard Carter Professor in the department of obstetrics and gynecology at Duke University, Durham, N.C., said in a press release.

Dr. Gianos is a consultant and/or on the advisory board for Regeneron. Dr. Wenger reports research grants from Gilead Sciences, the National Heart, Lung, and Blood Institute, Pfizer, and the Society for Women’s Health Research and is a consultant and/or on the advisory board for Amgen, AstraZeneca, Gilead Sciences, Janssen, and Merck.

SOURCE: Brown HL et al. Circulation. 2018 May 10. doi: 10.1161/CIR.0000000000000582.

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Key clinical point: Cardiology, obstetrics, and gynecology providers should use a woman’s annual visit to her ob.gyn. to promote healthy lifestyle choices, screen for signs of cardiovascular disease and risk factors, and improve her overall cardiovascular health.

Major finding: Women are at greater risk than men are of cardiovascular mortality, hypertension, and hypercholesterolemia, and of developing diabetes mellitus–associated cardiovascular risk factors, with factors such as pregnancy, obesity, smoking status, mental health, and genetic risk factors also playing a role in cardiovascular health.

Study details: A joint advisory statement from the presidents of the American Heart Association and the American College of Obstetricians and Gynecologists.

Disclosures: Dr. Gianos is a consultant and/or on the advisory board for Regeneron. Dr. Wenger reports research grants from Gilead Sciences, the National Heart, Lung, and Blood Institute, Pfizer, and the Society for Women’s Health Research and is a consultant and/or on the advisory board for Amgen, AstraZeneca, Gilead Sciences, Janssen, and Merck.

Source: Brown HL et al. Circulation. 2018 May 10. doi: 10.1161/CIR.0000000000000582.

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Class III obesity increases risk of acute on chronic liver failure in cirrhotic patients

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Class III obesity was significantly, independently associated with acute on chronic liver failure (ACLF) in patients with decompensated cirrhosis, and patients with both class III obesity and acute on chronic liver failure also had a significant risk of renal failure, according to a recent retrospective analysis of two databases publised in the Journal of Hepatology.

Vinay Sundaram, MD, from Cedars-Sinai Medical Center in Los Angeles, and his colleagues evaluated 387,884 patients who were in the United Network for Organ Sharing (UNOS) during 2005-2016; were class I or II obese (body mass index 30-39 kg/m2), class III obese (BMI greater than or equal to 40), or not obese (BMI less than 30); and were on a wait list for liver transplantation.

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They used the definition of ACLF outlined in the CANONIC (Consortium Acute on Chronic Liver Failure in Cirrhosis) study, which defined it as having “a single hepatic decompensation, such as ascites, hepatic encephalopathy, variceal bleed, or bacterial infection, and one of the following organ failures: single renal failure, single nonrenal organ failure with renal dysfunction or hepatic encephalopathy, or two nonrenal organ failures,” and confirmed the results in the Nationwide Inpatient Sample (NIS) databases by using diagnostic coding algorithms to identify factors such as hepatic decompensation, obesity, and ACLF in that study population.

Dr. Sundarem and his colleagues identified 116,704 patients (30.1%) with acute on chronic liver failure in both the UNOS and NIS databases. At the time of liver transplantation, there was a significant association between ACLF and class I and class II obesity (hazard ratio, 1.12; 95% confidence interval, 1.05-1.19; P less than .001) and class III obesity (HR, 1.24; 95% CI, 1.09-1.41; P less than .001). Other predictors of ACLF in this population were increased age (HR, 1.01 per year; 95% CI, 1.00-1.01; P = .037), hepatitis C virus (HR, 1.25; 95% CI, 1.16-1.35; P less than .001) and hepatitis C combined with alcoholic liver disease (HR, 1.18; 95% CI, 1.06-1.30; P = .002). Regarding organ failure, “renal insufficiency was similar among the three groups,” with increasing obesity class associated with a greater prevalence of renal failure.

“Given the heightened risk of renal failure among obese patients with cirrhosis, we suggest particularly careful management of this fragile population regarding diuretic usage, avoidance of nephrotoxic agents, and administration of an adequate albumin challenge in the setting of acute kidney injury,” the researchers wrote.

The researchers encouraged “an even greater emphasis on weight reduction” for class III obese patients. They noted the association between class III obesity and ACLF is likely caused by an “obesity-related chronic inflammatory state” and said future prospective studies should seek to describe the inflammatory pathways for each condition to predict risk of ACLF in these patients.

The authors reported having no financial disclosures.

SOURCE: Sundarem V et al. J Hepatol. 2018 April 27. doi: 10.1016/j.jhep.2018.04.016.

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Class III obesity was significantly, independently associated with acute on chronic liver failure (ACLF) in patients with decompensated cirrhosis, and patients with both class III obesity and acute on chronic liver failure also had a significant risk of renal failure, according to a recent retrospective analysis of two databases publised in the Journal of Hepatology.

Vinay Sundaram, MD, from Cedars-Sinai Medical Center in Los Angeles, and his colleagues evaluated 387,884 patients who were in the United Network for Organ Sharing (UNOS) during 2005-2016; were class I or II obese (body mass index 30-39 kg/m2), class III obese (BMI greater than or equal to 40), or not obese (BMI less than 30); and were on a wait list for liver transplantation.

pixologicstudio/Thinkstock

They used the definition of ACLF outlined in the CANONIC (Consortium Acute on Chronic Liver Failure in Cirrhosis) study, which defined it as having “a single hepatic decompensation, such as ascites, hepatic encephalopathy, variceal bleed, or bacterial infection, and one of the following organ failures: single renal failure, single nonrenal organ failure with renal dysfunction or hepatic encephalopathy, or two nonrenal organ failures,” and confirmed the results in the Nationwide Inpatient Sample (NIS) databases by using diagnostic coding algorithms to identify factors such as hepatic decompensation, obesity, and ACLF in that study population.

Dr. Sundarem and his colleagues identified 116,704 patients (30.1%) with acute on chronic liver failure in both the UNOS and NIS databases. At the time of liver transplantation, there was a significant association between ACLF and class I and class II obesity (hazard ratio, 1.12; 95% confidence interval, 1.05-1.19; P less than .001) and class III obesity (HR, 1.24; 95% CI, 1.09-1.41; P less than .001). Other predictors of ACLF in this population were increased age (HR, 1.01 per year; 95% CI, 1.00-1.01; P = .037), hepatitis C virus (HR, 1.25; 95% CI, 1.16-1.35; P less than .001) and hepatitis C combined with alcoholic liver disease (HR, 1.18; 95% CI, 1.06-1.30; P = .002). Regarding organ failure, “renal insufficiency was similar among the three groups,” with increasing obesity class associated with a greater prevalence of renal failure.

“Given the heightened risk of renal failure among obese patients with cirrhosis, we suggest particularly careful management of this fragile population regarding diuretic usage, avoidance of nephrotoxic agents, and administration of an adequate albumin challenge in the setting of acute kidney injury,” the researchers wrote.

The researchers encouraged “an even greater emphasis on weight reduction” for class III obese patients. They noted the association between class III obesity and ACLF is likely caused by an “obesity-related chronic inflammatory state” and said future prospective studies should seek to describe the inflammatory pathways for each condition to predict risk of ACLF in these patients.

The authors reported having no financial disclosures.

SOURCE: Sundarem V et al. J Hepatol. 2018 April 27. doi: 10.1016/j.jhep.2018.04.016.

Class III obesity was significantly, independently associated with acute on chronic liver failure (ACLF) in patients with decompensated cirrhosis, and patients with both class III obesity and acute on chronic liver failure also had a significant risk of renal failure, according to a recent retrospective analysis of two databases publised in the Journal of Hepatology.

Vinay Sundaram, MD, from Cedars-Sinai Medical Center in Los Angeles, and his colleagues evaluated 387,884 patients who were in the United Network for Organ Sharing (UNOS) during 2005-2016; were class I or II obese (body mass index 30-39 kg/m2), class III obese (BMI greater than or equal to 40), or not obese (BMI less than 30); and were on a wait list for liver transplantation.

pixologicstudio/Thinkstock

They used the definition of ACLF outlined in the CANONIC (Consortium Acute on Chronic Liver Failure in Cirrhosis) study, which defined it as having “a single hepatic decompensation, such as ascites, hepatic encephalopathy, variceal bleed, or bacterial infection, and one of the following organ failures: single renal failure, single nonrenal organ failure with renal dysfunction or hepatic encephalopathy, or two nonrenal organ failures,” and confirmed the results in the Nationwide Inpatient Sample (NIS) databases by using diagnostic coding algorithms to identify factors such as hepatic decompensation, obesity, and ACLF in that study population.

Dr. Sundarem and his colleagues identified 116,704 patients (30.1%) with acute on chronic liver failure in both the UNOS and NIS databases. At the time of liver transplantation, there was a significant association between ACLF and class I and class II obesity (hazard ratio, 1.12; 95% confidence interval, 1.05-1.19; P less than .001) and class III obesity (HR, 1.24; 95% CI, 1.09-1.41; P less than .001). Other predictors of ACLF in this population were increased age (HR, 1.01 per year; 95% CI, 1.00-1.01; P = .037), hepatitis C virus (HR, 1.25; 95% CI, 1.16-1.35; P less than .001) and hepatitis C combined with alcoholic liver disease (HR, 1.18; 95% CI, 1.06-1.30; P = .002). Regarding organ failure, “renal insufficiency was similar among the three groups,” with increasing obesity class associated with a greater prevalence of renal failure.

“Given the heightened risk of renal failure among obese patients with cirrhosis, we suggest particularly careful management of this fragile population regarding diuretic usage, avoidance of nephrotoxic agents, and administration of an adequate albumin challenge in the setting of acute kidney injury,” the researchers wrote.

The researchers encouraged “an even greater emphasis on weight reduction” for class III obese patients. They noted the association between class III obesity and ACLF is likely caused by an “obesity-related chronic inflammatory state” and said future prospective studies should seek to describe the inflammatory pathways for each condition to predict risk of ACLF in these patients.

The authors reported having no financial disclosures.

SOURCE: Sundarem V et al. J Hepatol. 2018 April 27. doi: 10.1016/j.jhep.2018.04.016.

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Key clinical point: Patients with a BMI greater than or equal to 40 kg/m2 with decompensated cirrhosis are at greater risk of developing acute on chronic liver failure.

Major finding: Class III obesity carried a hazard ratio of 1.24 in the UNOS database and an odds ratio of 1.30 in the NIS database at the time of liver transplantation.

Data source: A retrospective cohort database study of 116,704 patients with acute on chronic liver failure listed during 2005-2016.

Disclosures: The authors reported having no financial disclosures.

Source: Sundaram V et al. J Hepatol. 2018 Apr 27. doi: 10.1016/j.jhep.2018.04.016.

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High Cajal cell count with gastric electrical stimulation improves symptoms for refractory gastroparesis patients

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Patients with drug-refractory gastroparesis with a high Cajal cell count who underwent neurostimulation showed symptomatic relief of one-hour gastric emptying and gastric electrical activity after the therapy, and researchers suggested patients with depleted Cajal cells who did not improve could have lost certain Cajal cells.

Thomas L. Abell, MD, from the department of medicine and division of gastroenterology, hepatology and nutrition at the University of Louisville (Ky.) and his colleagues recruited 23 patients with drug-refractory gastroparesis to undergo gastric electrical stimulation (GES) therapy for 12 months. Patients were white females with a mean age of 45.7 years. They performed a gastric-emptying test before therapy; the composite symptom scores were 23.89 plus or minus 34.10 for 4-hour gastric emptying in the group with interstitial cells of Cajal (ICC) less than 2.00 and a 22.62 plus or minus 25.51 in the group with ICC greater than or equal to 2.00.

“We believe neurostimulation might modify or augment the function of ICC cells. However, in patients with severe depletion, the ICC density might be too sparse to be augmented and hence contribute to suboptimal response to GES,” Dr. Abell and colleagues wrote in their study.

The GES system consisted of an “implanted pulse generator, two leads, and the stimulator programmer.” Patients used a trial GES system for 1-2 weeks, in which a “temporary lead is placed endoscopically through the nose and inserted into the gastric mucosa in the middle of the stomach.”

After the trial GES system, the researchers performed a gastric wall biopsy to determine ICC counts to divide the patients into two groups: those with less than 2 ICC and those with greater than or equal to 2 ICC (per high power field). Following the trial, a more permanent system was implanted and researchers analyzed results after 12 months with the Student t test, patient-reported symptom assessment, and Total Symptom Score (TSS) using a Likert scale.

After GES, 1-hour gastric emptying improved in the group with ICC greater than or equal to 2.00 from pretreatment (75.47 plus or minus 13.80) to posttreatment (57.97 plus or minus 21.34) with a mean between-group difference of 17.5% (95% confidence interval, 1.41-33.58; P = .035). Dr. Abell and colleagues noted a nonstatistically significant improvement in 2-hour (mean between-group difference, 8%) and 4-hour (4%) gastric emptying (P = .032). Compared with pretreatment, patients with an ICC count less that 2 showed no significant change at 1-hour (63.78 plus or minus 26.01 vs. 68.86 plus or minus 33.14; P = .646), 7% worsening at 2-hour (41.22 plus or minus 33.44 vs. 49.37 plus or minus 34.21; P = .343) and 7% worsening at 4-hour gastric emptying (23.89 plus or minus 34.10 vs. 30.82 plus or minus 30.82; P = .166).

Researchers found patients with “normal to moderate depletion of ICC counts” had a significantly higher change in serosal amplitude, with a mean amplitude change of 0.19 (P = .05). Patients with “severe depletion of ICC” showed no significant change in amplitude (mean amplitude change, 0.01; P = .79). Among patients with normal or moderate depletion of ICC, the pre-GES serosal frequency was 3.96 plus or minus 1.02 and the post-GES frequency was 3.83 plus or minus 1.36 (P = .79), while the patients with severe depletion of ICC had a pre-GES frequency of 4.67 plus or minus 1.57 and a post-GES frequency of 4.23 plus or minus 1.30 (P = .54).

 

 


Nausea and vomiting symptoms significantly improved in the group with ICC greater than or equal to 2.00 (vomiting change, –2.07; P less than .001 and bloating change, –1.80; P less than .001) with a weaker association with symptom improvement in the group with ICC less than 2.00 (vomiting change, –1.65; P =.035 and bloating change, –1.00; P = 0.86). TSS improved by 52% in the ICC group with greater than or equal to 2.00 (P = .002) and by 29.6% in the ICC less than 2.00 group (P = .047).

“The observation that some patients with severe depletion of ICC showed improvement in symptoms might indicate differential loss of specific type of ICC cells,” Dr. Abell and his colleagues wrote. “Better understanding of response to GES in patients with particular type of ICC loss might shed light on the mechanism of GES, as well as predicting and selecting patients who respond better. Future studies should focus on stratifying patients based on predominant type of ICC loss as it relates to severity of symptoms and response to GES.”

Dr. Abell is the founder of ADEPT-GI and has intellectual property rights related to the technology in this study. The other authors declare no relevant financial disclosures.

SOURCE: Omer E et al. J Clin Gastroenterol. 2018 Apr 18. doi: 10.1097/MCG.0000000000001025.

*This story was updated on 4/30/2018.

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Patients with drug-refractory gastroparesis with a high Cajal cell count who underwent neurostimulation showed symptomatic relief of one-hour gastric emptying and gastric electrical activity after the therapy, and researchers suggested patients with depleted Cajal cells who did not improve could have lost certain Cajal cells.

Thomas L. Abell, MD, from the department of medicine and division of gastroenterology, hepatology and nutrition at the University of Louisville (Ky.) and his colleagues recruited 23 patients with drug-refractory gastroparesis to undergo gastric electrical stimulation (GES) therapy for 12 months. Patients were white females with a mean age of 45.7 years. They performed a gastric-emptying test before therapy; the composite symptom scores were 23.89 plus or minus 34.10 for 4-hour gastric emptying in the group with interstitial cells of Cajal (ICC) less than 2.00 and a 22.62 plus or minus 25.51 in the group with ICC greater than or equal to 2.00.

“We believe neurostimulation might modify or augment the function of ICC cells. However, in patients with severe depletion, the ICC density might be too sparse to be augmented and hence contribute to suboptimal response to GES,” Dr. Abell and colleagues wrote in their study.

The GES system consisted of an “implanted pulse generator, two leads, and the stimulator programmer.” Patients used a trial GES system for 1-2 weeks, in which a “temporary lead is placed endoscopically through the nose and inserted into the gastric mucosa in the middle of the stomach.”

After the trial GES system, the researchers performed a gastric wall biopsy to determine ICC counts to divide the patients into two groups: those with less than 2 ICC and those with greater than or equal to 2 ICC (per high power field). Following the trial, a more permanent system was implanted and researchers analyzed results after 12 months with the Student t test, patient-reported symptom assessment, and Total Symptom Score (TSS) using a Likert scale.

After GES, 1-hour gastric emptying improved in the group with ICC greater than or equal to 2.00 from pretreatment (75.47 plus or minus 13.80) to posttreatment (57.97 plus or minus 21.34) with a mean between-group difference of 17.5% (95% confidence interval, 1.41-33.58; P = .035). Dr. Abell and colleagues noted a nonstatistically significant improvement in 2-hour (mean between-group difference, 8%) and 4-hour (4%) gastric emptying (P = .032). Compared with pretreatment, patients with an ICC count less that 2 showed no significant change at 1-hour (63.78 plus or minus 26.01 vs. 68.86 plus or minus 33.14; P = .646), 7% worsening at 2-hour (41.22 plus or minus 33.44 vs. 49.37 plus or minus 34.21; P = .343) and 7% worsening at 4-hour gastric emptying (23.89 plus or minus 34.10 vs. 30.82 plus or minus 30.82; P = .166).

Researchers found patients with “normal to moderate depletion of ICC counts” had a significantly higher change in serosal amplitude, with a mean amplitude change of 0.19 (P = .05). Patients with “severe depletion of ICC” showed no significant change in amplitude (mean amplitude change, 0.01; P = .79). Among patients with normal or moderate depletion of ICC, the pre-GES serosal frequency was 3.96 plus or minus 1.02 and the post-GES frequency was 3.83 plus or minus 1.36 (P = .79), while the patients with severe depletion of ICC had a pre-GES frequency of 4.67 plus or minus 1.57 and a post-GES frequency of 4.23 plus or minus 1.30 (P = .54).

 

 


Nausea and vomiting symptoms significantly improved in the group with ICC greater than or equal to 2.00 (vomiting change, –2.07; P less than .001 and bloating change, –1.80; P less than .001) with a weaker association with symptom improvement in the group with ICC less than 2.00 (vomiting change, –1.65; P =.035 and bloating change, –1.00; P = 0.86). TSS improved by 52% in the ICC group with greater than or equal to 2.00 (P = .002) and by 29.6% in the ICC less than 2.00 group (P = .047).

“The observation that some patients with severe depletion of ICC showed improvement in symptoms might indicate differential loss of specific type of ICC cells,” Dr. Abell and his colleagues wrote. “Better understanding of response to GES in patients with particular type of ICC loss might shed light on the mechanism of GES, as well as predicting and selecting patients who respond better. Future studies should focus on stratifying patients based on predominant type of ICC loss as it relates to severity of symptoms and response to GES.”

Dr. Abell is the founder of ADEPT-GI and has intellectual property rights related to the technology in this study. The other authors declare no relevant financial disclosures.

SOURCE: Omer E et al. J Clin Gastroenterol. 2018 Apr 18. doi: 10.1097/MCG.0000000000001025.

*This story was updated on 4/30/2018.

 

Patients with drug-refractory gastroparesis with a high Cajal cell count who underwent neurostimulation showed symptomatic relief of one-hour gastric emptying and gastric electrical activity after the therapy, and researchers suggested patients with depleted Cajal cells who did not improve could have lost certain Cajal cells.

Thomas L. Abell, MD, from the department of medicine and division of gastroenterology, hepatology and nutrition at the University of Louisville (Ky.) and his colleagues recruited 23 patients with drug-refractory gastroparesis to undergo gastric electrical stimulation (GES) therapy for 12 months. Patients were white females with a mean age of 45.7 years. They performed a gastric-emptying test before therapy; the composite symptom scores were 23.89 plus or minus 34.10 for 4-hour gastric emptying in the group with interstitial cells of Cajal (ICC) less than 2.00 and a 22.62 plus or minus 25.51 in the group with ICC greater than or equal to 2.00.

“We believe neurostimulation might modify or augment the function of ICC cells. However, in patients with severe depletion, the ICC density might be too sparse to be augmented and hence contribute to suboptimal response to GES,” Dr. Abell and colleagues wrote in their study.

The GES system consisted of an “implanted pulse generator, two leads, and the stimulator programmer.” Patients used a trial GES system for 1-2 weeks, in which a “temporary lead is placed endoscopically through the nose and inserted into the gastric mucosa in the middle of the stomach.”

After the trial GES system, the researchers performed a gastric wall biopsy to determine ICC counts to divide the patients into two groups: those with less than 2 ICC and those with greater than or equal to 2 ICC (per high power field). Following the trial, a more permanent system was implanted and researchers analyzed results after 12 months with the Student t test, patient-reported symptom assessment, and Total Symptom Score (TSS) using a Likert scale.

After GES, 1-hour gastric emptying improved in the group with ICC greater than or equal to 2.00 from pretreatment (75.47 plus or minus 13.80) to posttreatment (57.97 plus or minus 21.34) with a mean between-group difference of 17.5% (95% confidence interval, 1.41-33.58; P = .035). Dr. Abell and colleagues noted a nonstatistically significant improvement in 2-hour (mean between-group difference, 8%) and 4-hour (4%) gastric emptying (P = .032). Compared with pretreatment, patients with an ICC count less that 2 showed no significant change at 1-hour (63.78 plus or minus 26.01 vs. 68.86 plus or minus 33.14; P = .646), 7% worsening at 2-hour (41.22 plus or minus 33.44 vs. 49.37 plus or minus 34.21; P = .343) and 7% worsening at 4-hour gastric emptying (23.89 plus or minus 34.10 vs. 30.82 plus or minus 30.82; P = .166).

Researchers found patients with “normal to moderate depletion of ICC counts” had a significantly higher change in serosal amplitude, with a mean amplitude change of 0.19 (P = .05). Patients with “severe depletion of ICC” showed no significant change in amplitude (mean amplitude change, 0.01; P = .79). Among patients with normal or moderate depletion of ICC, the pre-GES serosal frequency was 3.96 plus or minus 1.02 and the post-GES frequency was 3.83 plus or minus 1.36 (P = .79), while the patients with severe depletion of ICC had a pre-GES frequency of 4.67 plus or minus 1.57 and a post-GES frequency of 4.23 plus or minus 1.30 (P = .54).

 

 


Nausea and vomiting symptoms significantly improved in the group with ICC greater than or equal to 2.00 (vomiting change, –2.07; P less than .001 and bloating change, –1.80; P less than .001) with a weaker association with symptom improvement in the group with ICC less than 2.00 (vomiting change, –1.65; P =.035 and bloating change, –1.00; P = 0.86). TSS improved by 52% in the ICC group with greater than or equal to 2.00 (P = .002) and by 29.6% in the ICC less than 2.00 group (P = .047).

“The observation that some patients with severe depletion of ICC showed improvement in symptoms might indicate differential loss of specific type of ICC cells,” Dr. Abell and his colleagues wrote. “Better understanding of response to GES in patients with particular type of ICC loss might shed light on the mechanism of GES, as well as predicting and selecting patients who respond better. Future studies should focus on stratifying patients based on predominant type of ICC loss as it relates to severity of symptoms and response to GES.”

Dr. Abell is the founder of ADEPT-GI and has intellectual property rights related to the technology in this study. The other authors declare no relevant financial disclosures.

SOURCE: Omer E et al. J Clin Gastroenterol. 2018 Apr 18. doi: 10.1097/MCG.0000000000001025.

*This story was updated on 4/30/2018.

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FROM JOURNAL OF CLINICAL GASTROENTEROLOGY

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Key clinical point: Higher Cajal cell counts were linked to improved symptoms and gastric electrical activity in patients with drug-refractory gastroparesis who underwent neurostimulation.

Major finding: The rate of 1-hour gastric emptying significantly improved in patients with interstitial cells of Cajal greater than or equal to two after gastric electrical stimulation with a mean group difference of 17.5%, as well as a mean serosal amplitude change of 0.19.

Study details: A single-center study of 23 women with drug-refractory gastroparesis recruited from the gastric motility clinic at the University of Mississippi.

Disclosures: Dr. Abell is the founder of ADEPT-GI and has intellectual property rights related to the technology in this study. The other authors declare no relevant financial disclosures.

Source: Omer E et al. J Clin Gastroenterol. 2018 Apr 18. doi: 10.1097/MCG.0000000000001025.

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