After last week’s ever-so-slightly positive news, the COVID-19 numbers in children have gone back to their old ways.

For the week ending Dec. 10, there were 178,823 new COVID-19 cases reported in U.S. children, the highest weekly total yet during the pandemic. The number of new cases had dropped the week before after setting a new high of almost 154,000 during the last full week of November, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

A new weekly high has been seen in 9 of the last 10 weeks, during which time the weekly total of child cases has gone from just over 40,000 (week ending Oct. 8) to almost 179,000, the two organizations said.

The cumulative number of child COVID-19 cases for the year is now almost 1.64 million, which means that 12.2% of all cases have occurred in children and that 2.1% of all children (2,179 per 100,000) in the United States have been infected with the coronavirus, the AAP and CHA said in their weekly report, which includes health department data from 49 states (New York does not report age distribution), the District of Columbia, New York City, Puerto Rico, and Guam.

The cumulative proportion of 12.2% has been exceeded in 27 states, as well as Puerto Rico and Guam, with the highest coming in Wyoming (21.3%), South Carolina (18.1%), and Tennessee (18.1%) and the lowest in Florida (6.7%, but the state uses an age range of 0-14 years) and New Jersey (7.6%), the AAP/CHA data show.

In a separate statement, AAP president Sally Goza, MD, welcomed the approval of the Pfizer-BioNTech COVID-19 vaccine but noted that the “virus is at unprecedented levels in nearly every community in the U.S., and in many areas, our health care system is terribly overburdened. The vaccine will not solve this overnight. I urge everyone to continue to practice social distancing, and wear masks or cloth face coverings, and get a flu shot, so we can protect the people we care about.”

Dr. Goza continued: “We applaud Pfizer-BioNTech for including children ages 12 through 17 in their clinical trials and we look forward to learning more about the data from children aged 12-15. We also want to acknowledge the discussion during the committee meeting on including 16- to 17-year-olds in the EUA [emergency-use authorization]. We believe that discussion underscores the need to keep expanding these trials to the pediatric population so we can collect robust data on this age group.”

rfranki@mdedge.com

 

After last week’s ever-so-slightly positive news, the COVID-19 numbers in children have gone back to their old ways.

For the week ending Dec. 10, there were 178,823 new COVID-19 cases reported in U.S. children, the highest weekly total yet during the pandemic. The number of new cases had dropped the week before after setting a new high of almost 154,000 during the last full week of November, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

A new weekly high has been seen in 9 of the last 10 weeks, during which time the weekly total of child cases has gone from just over 40,000 (week ending Oct. 8) to almost 179,000, the two organizations said.

The cumulative number of child COVID-19 cases for the year is now almost 1.64 million, which means that 12.2% of all cases have occurred in children and that 2.1% of all children (2,179 per 100,000) in the United States have been infected with the coronavirus, the AAP and CHA said in their weekly report, which includes health department data from 49 states (New York does not report age distribution), the District of Columbia, New York City, Puerto Rico, and Guam.

The cumulative proportion of 12.2% has been exceeded in 27 states, as well as Puerto Rico and Guam, with the highest coming in Wyoming (21.3%), South Carolina (18.1%), and Tennessee (18.1%) and the lowest in Florida (6.7%, but the state uses an age range of 0-14 years) and New Jersey (7.6%), the AAP/CHA data show.

In a separate statement, AAP president Sally Goza, MD, welcomed the approval of the Pfizer-BioNTech COVID-19 vaccine but noted that the “virus is at unprecedented levels in nearly every community in the U.S., and in many areas, our health care system is terribly overburdened. The vaccine will not solve this overnight. I urge everyone to continue to practice social distancing, and wear masks or cloth face coverings, and get a flu shot, so we can protect the people we care about.”

Dr. Goza continued: “We applaud Pfizer-BioNTech for including children ages 12 through 17 in their clinical trials and we look forward to learning more about the data from children aged 12-15. We also want to acknowledge the discussion during the committee meeting on including 16- to 17-year-olds in the EUA [emergency-use authorization]. We believe that discussion underscores the need to keep expanding these trials to the pediatric population so we can collect robust data on this age group.”

rfranki@mdedge.com

 

After last week’s ever-so-slightly positive news, the COVID-19 numbers in children have gone back to their old ways.

For the week ending Dec. 10, there were 178,823 new COVID-19 cases reported in U.S. children, the highest weekly total yet during the pandemic. The number of new cases had dropped the week before after setting a new high of almost 154,000 during the last full week of November, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

A new weekly high has been seen in 9 of the last 10 weeks, during which time the weekly total of child cases has gone from just over 40,000 (week ending Oct. 8) to almost 179,000, the two organizations said.

The cumulative number of child COVID-19 cases for the year is now almost 1.64 million, which means that 12.2% of all cases have occurred in children and that 2.1% of all children (2,179 per 100,000) in the United States have been infected with the coronavirus, the AAP and CHA said in their weekly report, which includes health department data from 49 states (New York does not report age distribution), the District of Columbia, New York City, Puerto Rico, and Guam.

The cumulative proportion of 12.2% has been exceeded in 27 states, as well as Puerto Rico and Guam, with the highest coming in Wyoming (21.3%), South Carolina (18.1%), and Tennessee (18.1%) and the lowest in Florida (6.7%, but the state uses an age range of 0-14 years) and New Jersey (7.6%), the AAP/CHA data show.

In a separate statement, AAP president Sally Goza, MD, welcomed the approval of the Pfizer-BioNTech COVID-19 vaccine but noted that the “virus is at unprecedented levels in nearly every community in the U.S., and in many areas, our health care system is terribly overburdened. The vaccine will not solve this overnight. I urge everyone to continue to practice social distancing, and wear masks or cloth face coverings, and get a flu shot, so we can protect the people we care about.”

Dr. Goza continued: “We applaud Pfizer-BioNTech for including children ages 12 through 17 in their clinical trials and we look forward to learning more about the data from children aged 12-15. We also want to acknowledge the discussion during the committee meeting on including 16- to 17-year-olds in the EUA [emergency-use authorization]. We believe that discussion underscores the need to keep expanding these trials to the pediatric population so we can collect robust data on this age group.”

rfranki@mdedge.com

 

Middle-aged women with PTSD and comorbid depression have a nearly fourfold increased risk for early death from a variety of causes in comparison with their peers who do not have those conditions, new research shows.

“Women with more severe symptoms of depression and PTSD were more at risk, compared with those with fewer symptoms or women with symptoms of only PTSD or only depression,” lead investigator Andrea Roberts, PhD, Harvard School of Public Health, Boston, said in an interview.

Health care providers “should be aware that mental health is a critical component of overall health and is tightly entwined with physical health. Identifying and treating mental health issues should be a foundational part of general health practice,” said Dr. Roberts.

The study was published online Dec. 4 in JAMA Network Open.
 

Mental health fundamental to survival

The researchers studied more than 51,000 mostly White women from the Nurses Health Study II who were followed for 9 years (2008-2017). At baseline in 2008, the women were aged between 43 and 64 years (mean age, 53.3 years).

Women with high levels of PTSD (six or seven symptoms) and probable depression were nearly four times more likely to die during follow-up than their peers who did not have these conditions (hazard ratio, 3.8; 95% confidence interval, 2.65-5.45; P < .001).

With adjustment for health factors such as smoking and body mass index, women with a high level of PTSD and depression remained at increased risk for early death (HR, 3.11; 95% CI, 2.16-4.47; P < .001).

The risk for early death was also elevated among women with moderate PTSD (four or five symptoms) and depression (HR, 2.03; 95% CI, 1.35-3.03; P < .001) and women with subclinical PTSD and depression (HR, 2.85; 95% CI, 1.99-4.07; P < .001) compared with those who did not have PTSD or depression.

Among women with PTSD symptoms and depression, the incidence of death from nearly all major causes was increased, including death from cardiovascular disease, respiratory disease, type 2 diabetes, unintentional injury, suicide, and other causes.

“These findings provide further evidence that mental health is fundamental to physical health – and to our very survival. We ignore our emotional well-being at our peril,” senior author Karestan Koenen, PhD, said in a news release.
 

New knowledge

Commenting on the findings, Jennifer Sumner, PhD, said that it’s “critical to appreciate the physical health consequences of psychopathology in individuals who have experienced trauma. This study adds to a growing literature demonstrating that the impact extends far beyond emotional health.

“Furthermore, these results highlight the potential value of promoting healthy lifestyle changes in order to reduce the elevated mortality risk in trauma-exposed individuals with co-occurring PTSD and depression,” said Dr. Sumner, who is with the department of psychology, University of California, Los Angeles.

She noted that this study builds on other work that links PTSD to mortality in men.

“Most work on posttraumatic psychopathology and physical health has actually been conducted in predominantly male samples of veterans, so these findings in women exposed to a variety of traumatic experiences extend the literature in important ways,” said Dr. Sumner.

“It’s also important to note that PTSD and depression are more prevalent in women than in men, so demonstrating these associations in women is particularly relevant,” she added.

Funding for the study was provided by the National Institutes of Heath. The authors disclosed no relevant financial relationships. Dr. Sumner has collaborated with the study investigators on prior studies.

A version of this article originally appeared on Medscape.com.

Middle-aged women with PTSD and comorbid depression have a nearly fourfold increased risk for early death from a variety of causes in comparison with their peers who do not have those conditions, new research shows.

“Women with more severe symptoms of depression and PTSD were more at risk, compared with those with fewer symptoms or women with symptoms of only PTSD or only depression,” lead investigator Andrea Roberts, PhD, Harvard School of Public Health, Boston, said in an interview.

Health care providers “should be aware that mental health is a critical component of overall health and is tightly entwined with physical health. Identifying and treating mental health issues should be a foundational part of general health practice,” said Dr. Roberts.

The study was published online Dec. 4 in JAMA Network Open.
 

Mental health fundamental to survival

The researchers studied more than 51,000 mostly White women from the Nurses Health Study II who were followed for 9 years (2008-2017). At baseline in 2008, the women were aged between 43 and 64 years (mean age, 53.3 years).

Women with high levels of PTSD (six or seven symptoms) and probable depression were nearly four times more likely to die during follow-up than their peers who did not have these conditions (hazard ratio, 3.8; 95% confidence interval, 2.65-5.45; P < .001).

With adjustment for health factors such as smoking and body mass index, women with a high level of PTSD and depression remained at increased risk for early death (HR, 3.11; 95% CI, 2.16-4.47; P < .001).

The risk for early death was also elevated among women with moderate PTSD (four or five symptoms) and depression (HR, 2.03; 95% CI, 1.35-3.03; P < .001) and women with subclinical PTSD and depression (HR, 2.85; 95% CI, 1.99-4.07; P < .001) compared with those who did not have PTSD or depression.

Among women with PTSD symptoms and depression, the incidence of death from nearly all major causes was increased, including death from cardiovascular disease, respiratory disease, type 2 diabetes, unintentional injury, suicide, and other causes.

“These findings provide further evidence that mental health is fundamental to physical health – and to our very survival. We ignore our emotional well-being at our peril,” senior author Karestan Koenen, PhD, said in a news release.
 

New knowledge

Commenting on the findings, Jennifer Sumner, PhD, said that it’s “critical to appreciate the physical health consequences of psychopathology in individuals who have experienced trauma. This study adds to a growing literature demonstrating that the impact extends far beyond emotional health.

“Furthermore, these results highlight the potential value of promoting healthy lifestyle changes in order to reduce the elevated mortality risk in trauma-exposed individuals with co-occurring PTSD and depression,” said Dr. Sumner, who is with the department of psychology, University of California, Los Angeles.

She noted that this study builds on other work that links PTSD to mortality in men.

“Most work on posttraumatic psychopathology and physical health has actually been conducted in predominantly male samples of veterans, so these findings in women exposed to a variety of traumatic experiences extend the literature in important ways,” said Dr. Sumner.

“It’s also important to note that PTSD and depression are more prevalent in women than in men, so demonstrating these associations in women is particularly relevant,” she added.

Funding for the study was provided by the National Institutes of Heath. The authors disclosed no relevant financial relationships. Dr. Sumner has collaborated with the study investigators on prior studies.

A version of this article originally appeared on Medscape.com.

Middle-aged women with PTSD and comorbid depression have a nearly fourfold increased risk for early death from a variety of causes in comparison with their peers who do not have those conditions, new research shows.

“Women with more severe symptoms of depression and PTSD were more at risk, compared with those with fewer symptoms or women with symptoms of only PTSD or only depression,” lead investigator Andrea Roberts, PhD, Harvard School of Public Health, Boston, said in an interview.

Health care providers “should be aware that mental health is a critical component of overall health and is tightly entwined with physical health. Identifying and treating mental health issues should be a foundational part of general health practice,” said Dr. Roberts.

The study was published online Dec. 4 in JAMA Network Open.
 

Mental health fundamental to survival

The researchers studied more than 51,000 mostly White women from the Nurses Health Study II who were followed for 9 years (2008-2017). At baseline in 2008, the women were aged between 43 and 64 years (mean age, 53.3 years).

Women with high levels of PTSD (six or seven symptoms) and probable depression were nearly four times more likely to die during follow-up than their peers who did not have these conditions (hazard ratio, 3.8; 95% confidence interval, 2.65-5.45; P < .001).

With adjustment for health factors such as smoking and body mass index, women with a high level of PTSD and depression remained at increased risk for early death (HR, 3.11; 95% CI, 2.16-4.47; P < .001).

The risk for early death was also elevated among women with moderate PTSD (four or five symptoms) and depression (HR, 2.03; 95% CI, 1.35-3.03; P < .001) and women with subclinical PTSD and depression (HR, 2.85; 95% CI, 1.99-4.07; P < .001) compared with those who did not have PTSD or depression.

Among women with PTSD symptoms and depression, the incidence of death from nearly all major causes was increased, including death from cardiovascular disease, respiratory disease, type 2 diabetes, unintentional injury, suicide, and other causes.

“These findings provide further evidence that mental health is fundamental to physical health – and to our very survival. We ignore our emotional well-being at our peril,” senior author Karestan Koenen, PhD, said in a news release.
 

New knowledge

Commenting on the findings, Jennifer Sumner, PhD, said that it’s “critical to appreciate the physical health consequences of psychopathology in individuals who have experienced trauma. This study adds to a growing literature demonstrating that the impact extends far beyond emotional health.

“Furthermore, these results highlight the potential value of promoting healthy lifestyle changes in order to reduce the elevated mortality risk in trauma-exposed individuals with co-occurring PTSD and depression,” said Dr. Sumner, who is with the department of psychology, University of California, Los Angeles.

She noted that this study builds on other work that links PTSD to mortality in men.

“Most work on posttraumatic psychopathology and physical health has actually been conducted in predominantly male samples of veterans, so these findings in women exposed to a variety of traumatic experiences extend the literature in important ways,” said Dr. Sumner.

“It’s also important to note that PTSD and depression are more prevalent in women than in men, so demonstrating these associations in women is particularly relevant,” she added.

Funding for the study was provided by the National Institutes of Heath. The authors disclosed no relevant financial relationships. Dr. Sumner has collaborated with the study investigators on prior studies.

A version of this article originally appeared on Medscape.com.

Key clinical point: A mutation load of the gene U2AF1 (VAF > 40%) was an independent indicator of lower 1-year survival in adults with myelodysplastic syndrome.

Major finding: Myelodysplastic syndrome patients with a higher mutation load of U2AF1 (VAF > 40%) had a significantly lower 1-year survival rate compared to those with a mutation load of VAF 40 or lower (46.1% and 80.5%, respectively, P= 0.027). 

Study details: The data come from genetic analyses of 234 myelodysplastic syndrome patients aged 17 to 86 years; a total of 51 patients had an U2AF1 mutation at 52 mutation sites. 

Disclosures: The study was supported by the National Natural Science Foundation of China; Henan Natural Science Foundation of China and by the Henan Medical Science and Technology Research Project, Key Scientific Research Project of Henan Provincial Education Department. The researchers had no financial conflicts to disclose.

Source: Wang H et al. Sci Rep. 2020 Oct 29. doi: 10.1038/s41598-020-74744-z.

Key clinical point: A mutation load of the gene U2AF1 (VAF > 40%) was an independent indicator of lower 1-year survival in adults with myelodysplastic syndrome.

Major finding: Myelodysplastic syndrome patients with a higher mutation load of U2AF1 (VAF > 40%) had a significantly lower 1-year survival rate compared to those with a mutation load of VAF 40 or lower (46.1% and 80.5%, respectively, P= 0.027). 

Study details: The data come from genetic analyses of 234 myelodysplastic syndrome patients aged 17 to 86 years; a total of 51 patients had an U2AF1 mutation at 52 mutation sites. 

Disclosures: The study was supported by the National Natural Science Foundation of China; Henan Natural Science Foundation of China and by the Henan Medical Science and Technology Research Project, Key Scientific Research Project of Henan Provincial Education Department. The researchers had no financial conflicts to disclose.

Source: Wang H et al. Sci Rep. 2020 Oct 29. doi: 10.1038/s41598-020-74744-z.

Key clinical point: A mutation load of the gene U2AF1 (VAF > 40%) was an independent indicator of lower 1-year survival in adults with myelodysplastic syndrome.

Major finding: Myelodysplastic syndrome patients with a higher mutation load of U2AF1 (VAF > 40%) had a significantly lower 1-year survival rate compared to those with a mutation load of VAF 40 or lower (46.1% and 80.5%, respectively, P= 0.027). 

Study details: The data come from genetic analyses of 234 myelodysplastic syndrome patients aged 17 to 86 years; a total of 51 patients had an U2AF1 mutation at 52 mutation sites. 

Disclosures: The study was supported by the National Natural Science Foundation of China; Henan Natural Science Foundation of China and by the Henan Medical Science and Technology Research Project, Key Scientific Research Project of Henan Provincial Education Department. The researchers had no financial conflicts to disclose.

Source: Wang H et al. Sci Rep. 2020 Oct 29. doi: 10.1038/s41598-020-74744-z.

Key clinical point: Novel gene fusions may have a role in developing biomarkers for monitoring of minimal residual disease (MRD) in patients with acute myeloid leukemia and myelodysplastic syndrome.

Major finding: Overall, gene fusion events occurred in 37% of patients with acute myeloid leukemia compared to 3% of those with myelodysplastic syndrome. In addition, 67% of AML patients had TB53 mutations and 71% had complex karyotypes, compared with 26% and 21%, respectively, of MDS patients.

Study details: The data come from a review of gene transcripts from 572 adults with acute myeloid leukemia and 630 with myelodysplastic syndrome.

Disclosures: The study received no outside funding. Lead author Dr. Stengel had no financial conflicts to disclose.

Source: Stengel A et al. Blood Adv. 2020 Nov 10. doi: 10.1182/bloodadvances.2020003007.

Key clinical point: Novel gene fusions may have a role in developing biomarkers for monitoring of minimal residual disease (MRD) in patients with acute myeloid leukemia and myelodysplastic syndrome.

Major finding: Overall, gene fusion events occurred in 37% of patients with acute myeloid leukemia compared to 3% of those with myelodysplastic syndrome. In addition, 67% of AML patients had TB53 mutations and 71% had complex karyotypes, compared with 26% and 21%, respectively, of MDS patients.

Study details: The data come from a review of gene transcripts from 572 adults with acute myeloid leukemia and 630 with myelodysplastic syndrome.

Disclosures: The study received no outside funding. Lead author Dr. Stengel had no financial conflicts to disclose.

Source: Stengel A et al. Blood Adv. 2020 Nov 10. doi: 10.1182/bloodadvances.2020003007.

Key clinical point: Novel gene fusions may have a role in developing biomarkers for monitoring of minimal residual disease (MRD) in patients with acute myeloid leukemia and myelodysplastic syndrome.

Major finding: Overall, gene fusion events occurred in 37% of patients with acute myeloid leukemia compared to 3% of those with myelodysplastic syndrome. In addition, 67% of AML patients had TB53 mutations and 71% had complex karyotypes, compared with 26% and 21%, respectively, of MDS patients.

Study details: The data come from a review of gene transcripts from 572 adults with acute myeloid leukemia and 630 with myelodysplastic syndrome.

Disclosures: The study received no outside funding. Lead author Dr. Stengel had no financial conflicts to disclose.

Source: Stengel A et al. Blood Adv. 2020 Nov 10. doi: 10.1182/bloodadvances.2020003007.

Key clinical point: Azacitidine was safe but had no significant impact on relapse-free survival after transplant in in patients with acute myeloid leukemia/myelodysplastic syndrome 

Major finding: Median relapse-free survival (RFS) was 2.07 years in the azacitidine group vs. 1.28 years in the control group (P = .19). 

Study details: The data come from a phase 3 open-label randomized trial of 187 patients aged 18 to 75 years with acute myeloid leukemia/myelodysplastic syndrome (AML/MDS); patients received 32 mg/m2 of azacitidine daily for 5 days every 28 days for 12 cycles.

Disclosures: The study was supported by Celgene Pharmaceuticals. Lead author Dr. Oran disclosed serving as a consultant for Celgene and receiving research funding from AROG Pharmaceuticals and Astex Pharmaceuticals.

Source: Oran B et al. Blood Adv. 2020 Nov 10. doi: 10.1182/bloodadvances.2020002544.

Key clinical point: Azacitidine was safe but had no significant impact on relapse-free survival after transplant in in patients with acute myeloid leukemia/myelodysplastic syndrome 

Major finding: Median relapse-free survival (RFS) was 2.07 years in the azacitidine group vs. 1.28 years in the control group (P = .19). 

Study details: The data come from a phase 3 open-label randomized trial of 187 patients aged 18 to 75 years with acute myeloid leukemia/myelodysplastic syndrome (AML/MDS); patients received 32 mg/m2 of azacitidine daily for 5 days every 28 days for 12 cycles.

Disclosures: The study was supported by Celgene Pharmaceuticals. Lead author Dr. Oran disclosed serving as a consultant for Celgene and receiving research funding from AROG Pharmaceuticals and Astex Pharmaceuticals.

Source: Oran B et al. Blood Adv. 2020 Nov 10. doi: 10.1182/bloodadvances.2020002544.

Key clinical point: Azacitidine was safe but had no significant impact on relapse-free survival after transplant in in patients with acute myeloid leukemia/myelodysplastic syndrome 

Major finding: Median relapse-free survival (RFS) was 2.07 years in the azacitidine group vs. 1.28 years in the control group (P = .19). 

Study details: The data come from a phase 3 open-label randomized trial of 187 patients aged 18 to 75 years with acute myeloid leukemia/myelodysplastic syndrome (AML/MDS); patients received 32 mg/m2 of azacitidine daily for 5 days every 28 days for 12 cycles.

Disclosures: The study was supported by Celgene Pharmaceuticals. Lead author Dr. Oran disclosed serving as a consultant for Celgene and receiving research funding from AROG Pharmaceuticals and Astex Pharmaceuticals.

Source: Oran B et al. Blood Adv. 2020 Nov 10. doi: 10.1182/bloodadvances.2020002544.

Key clinical point: Imetelstat increased transfusion independence for patients with lower risk myelodysplastic syndromes who were resistant or refractory to treatment with erythropoiesis-stimulating agent.

Major finding: At 8 weeks, 37% of the patients were red blood cell transfusion independent, with an average duration of 65 weeks.

Study details: The data come from a phase II study of 57 adult patients with lower-risk myelodysplastic syndromes dependent on red blood cell transfusion and relapsed or refractory to erythropoiesis-stimulating agent; patients received imetelstat with a primary endpoint of red blood cell transfusion independence at 8 weeks.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Steensma DP et al. J Clin Oncol. 2020 Oct 27. doi: 10.1200/JCO.20.01895. 

Key clinical point: Imetelstat increased transfusion independence for patients with lower risk myelodysplastic syndromes who were resistant or refractory to treatment with erythropoiesis-stimulating agent.

Major finding: At 8 weeks, 37% of the patients were red blood cell transfusion independent, with an average duration of 65 weeks.

Study details: The data come from a phase II study of 57 adult patients with lower-risk myelodysplastic syndromes dependent on red blood cell transfusion and relapsed or refractory to erythropoiesis-stimulating agent; patients received imetelstat with a primary endpoint of red blood cell transfusion independence at 8 weeks.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Steensma DP et al. J Clin Oncol. 2020 Oct 27. doi: 10.1200/JCO.20.01895. 

Key clinical point: Imetelstat increased transfusion independence for patients with lower risk myelodysplastic syndromes who were resistant or refractory to treatment with erythropoiesis-stimulating agent.

Major finding: At 8 weeks, 37% of the patients were red blood cell transfusion independent, with an average duration of 65 weeks.

Study details: The data come from a phase II study of 57 adult patients with lower-risk myelodysplastic syndromes dependent on red blood cell transfusion and relapsed or refractory to erythropoiesis-stimulating agent; patients received imetelstat with a primary endpoint of red blood cell transfusion independence at 8 weeks.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Steensma DP et al. J Clin Oncol. 2020 Oct 27. doi: 10.1200/JCO.20.01895. 

Key clinical point: Food supplements coenzyme Q10 and carnitine significantly improved mitochondrial respiration in patients with low-risk myelodysplastic syndrome

Major finding: A total of 6 patients (21.4%) achieved hematological improvement based on the International Working Group (IWG) response criteria for MDS after 6 months.

Study details: The data come from an open-label study of 33 adults with myelodysplastic syndrome aged 56 to 93 years who received a combination of coenzyme Q10 at 180 mg/day L-carnitine at 2000 mg/ day, and a standard vitamin-mineral complex daily.

Disclosures: The study was supported by the Rising Tide Foundation and Israel Society of Hematology and Blood Transfusion. The researchers had no financial conflicts to disclose.

Source: Filanovsky K et al. Mediterr J Hemtol Infec Dis. 2020 Nov 1. doi: 10.4084/MJHID.2020.072.

Key clinical point: Food supplements coenzyme Q10 and carnitine significantly improved mitochondrial respiration in patients with low-risk myelodysplastic syndrome

Major finding: A total of 6 patients (21.4%) achieved hematological improvement based on the International Working Group (IWG) response criteria for MDS after 6 months.

Study details: The data come from an open-label study of 33 adults with myelodysplastic syndrome aged 56 to 93 years who received a combination of coenzyme Q10 at 180 mg/day L-carnitine at 2000 mg/ day, and a standard vitamin-mineral complex daily.

Disclosures: The study was supported by the Rising Tide Foundation and Israel Society of Hematology and Blood Transfusion. The researchers had no financial conflicts to disclose.

Source: Filanovsky K et al. Mediterr J Hemtol Infec Dis. 2020 Nov 1. doi: 10.4084/MJHID.2020.072.

Key clinical point: Food supplements coenzyme Q10 and carnitine significantly improved mitochondrial respiration in patients with low-risk myelodysplastic syndrome

Major finding: A total of 6 patients (21.4%) achieved hematological improvement based on the International Working Group (IWG) response criteria for MDS after 6 months.

Study details: The data come from an open-label study of 33 adults with myelodysplastic syndrome aged 56 to 93 years who received a combination of coenzyme Q10 at 180 mg/day L-carnitine at 2000 mg/ day, and a standard vitamin-mineral complex daily.

Disclosures: The study was supported by the Rising Tide Foundation and Israel Society of Hematology and Blood Transfusion. The researchers had no financial conflicts to disclose.

Source: Filanovsky K et al. Mediterr J Hemtol Infec Dis. 2020 Nov 1. doi: 10.4084/MJHID.2020.072.

Key clinical point: The financial burden of monthly azacitidine must be weighed against the benefits of treatment, but patients with acute myeloid leukemia and myelodysplastic syndrome have few options.

Major finding: A total of 31 patients with measurable residual disease at baseline were relapse-free and alive after 6 months of monthly injection treatment with azacitidine.

Study details: The data come from a review of the pros and cons of the RELAZA-2, a German-multicentered, open-label, single-arm, phase II study of azacitidine in 53 adult patients who developed measurable residual disease after treatment for acute myeloid leukemia or advanced myelodysplastic syndrome; 29 after chemotherapy and 24 after allogeneic hematopoietic stem cell transplantation (ASCT).

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Pan J et al. Front Oncol. 2020 Oct 22. doi: 10.3389/fonc.2020.576924.

Key clinical point: The financial burden of monthly azacitidine must be weighed against the benefits of treatment, but patients with acute myeloid leukemia and myelodysplastic syndrome have few options.

Major finding: A total of 31 patients with measurable residual disease at baseline were relapse-free and alive after 6 months of monthly injection treatment with azacitidine.

Study details: The data come from a review of the pros and cons of the RELAZA-2, a German-multicentered, open-label, single-arm, phase II study of azacitidine in 53 adult patients who developed measurable residual disease after treatment for acute myeloid leukemia or advanced myelodysplastic syndrome; 29 after chemotherapy and 24 after allogeneic hematopoietic stem cell transplantation (ASCT).

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Pan J et al. Front Oncol. 2020 Oct 22. doi: 10.3389/fonc.2020.576924.

Key clinical point: The financial burden of monthly azacitidine must be weighed against the benefits of treatment, but patients with acute myeloid leukemia and myelodysplastic syndrome have few options.

Major finding: A total of 31 patients with measurable residual disease at baseline were relapse-free and alive after 6 months of monthly injection treatment with azacitidine.

Study details: The data come from a review of the pros and cons of the RELAZA-2, a German-multicentered, open-label, single-arm, phase II study of azacitidine in 53 adult patients who developed measurable residual disease after treatment for acute myeloid leukemia or advanced myelodysplastic syndrome; 29 after chemotherapy and 24 after allogeneic hematopoietic stem cell transplantation (ASCT).

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Pan J et al. Front Oncol. 2020 Oct 22. doi: 10.3389/fonc.2020.576924.

Key clinical point: A novel retinoic acid receptor alpha agonist appeared safe in a phase 1 study of patients with relapsed and refractory high-grade myelodysplastic syndrome or acute myelogenous leukemia.

Major finding: A total of 4 of 11 patients (36%) had stable disease or better after two 28-day treatment cycles; the study ended early because of an inadequate supply of the drug.

Study details: The data come from a phase 1 dose-escalation study of the novel retinoic acid receptor alpha agonist IRX195183; 11 adults aged 18 to 60 years with relapsed or refractory myelodysplastic syndrome or acute myelogenous leukemia received the drug for two 28-day cycles with dosage starting at 50 mg daily or 75 mg daily.

Disclosures: The study was supported by the National Heart, Lung, and Blood Institute, the National Cancer Institute, the Leukemia and Lymphoma Society, and the Augustine Fellowship. IRX195183 was provided by Io Therapeutics, Inc. Lead author Dr. Ambinder had no financial conflicts to disclose. Several coauthors are authors on a patent for the use of IRX195183.

Source: Ambinder AJ et al. Front Oncol. 2020 Oct 23. doi: 10.3389/fonc.2020.587062.

Key clinical point: A novel retinoic acid receptor alpha agonist appeared safe in a phase 1 study of patients with relapsed and refractory high-grade myelodysplastic syndrome or acute myelogenous leukemia.

Major finding: A total of 4 of 11 patients (36%) had stable disease or better after two 28-day treatment cycles; the study ended early because of an inadequate supply of the drug.

Study details: The data come from a phase 1 dose-escalation study of the novel retinoic acid receptor alpha agonist IRX195183; 11 adults aged 18 to 60 years with relapsed or refractory myelodysplastic syndrome or acute myelogenous leukemia received the drug for two 28-day cycles with dosage starting at 50 mg daily or 75 mg daily.

Disclosures: The study was supported by the National Heart, Lung, and Blood Institute, the National Cancer Institute, the Leukemia and Lymphoma Society, and the Augustine Fellowship. IRX195183 was provided by Io Therapeutics, Inc. Lead author Dr. Ambinder had no financial conflicts to disclose. Several coauthors are authors on a patent for the use of IRX195183.

Source: Ambinder AJ et al. Front Oncol. 2020 Oct 23. doi: 10.3389/fonc.2020.587062.

Key clinical point: A novel retinoic acid receptor alpha agonist appeared safe in a phase 1 study of patients with relapsed and refractory high-grade myelodysplastic syndrome or acute myelogenous leukemia.

Major finding: A total of 4 of 11 patients (36%) had stable disease or better after two 28-day treatment cycles; the study ended early because of an inadequate supply of the drug.

Study details: The data come from a phase 1 dose-escalation study of the novel retinoic acid receptor alpha agonist IRX195183; 11 adults aged 18 to 60 years with relapsed or refractory myelodysplastic syndrome or acute myelogenous leukemia received the drug for two 28-day cycles with dosage starting at 50 mg daily or 75 mg daily.

Disclosures: The study was supported by the National Heart, Lung, and Blood Institute, the National Cancer Institute, the Leukemia and Lymphoma Society, and the Augustine Fellowship. IRX195183 was provided by Io Therapeutics, Inc. Lead author Dr. Ambinder had no financial conflicts to disclose. Several coauthors are authors on a patent for the use of IRX195183.

Source: Ambinder AJ et al. Front Oncol. 2020 Oct 23. doi: 10.3389/fonc.2020.587062.

The Department of Health & Human Services is proposing an overhaul of HIPAA that will make it easier to access patients’ personal health information, including the health records of patients with mental illness. The proposal would also do away with the requirement that all patients sign a notice of privacy practices.

The changes are contained in a 357-page proposed rule, which was unveiled by federal officials Dec. 10. Roger Severino, director of HHS’ Office for Civil Rights, said in a briefing that the sweeping proposal would empower patients, reduce the administrative burden for health care providers, and pave the way to better-coordinated care.

HHS estimated that the rule could save $3.2 billion over 5 years, but it’s not clear how much of that would accrue to clinical practices.

The most obvious cost-saving aspect for medical and dental practices is the proposal that practitioners would no longer have to provide and collect signed notifications of privacy practices.

“This has been a tremendous waste of time and effort and has caused massive confusion,” said Mr. Severino. He said some patients thought they were waiving privacy rights and that, in some cases, physicians refused to administer care unless patients signed the notices. “That was never the intent.”

Requiring that patients sign the form and that practices keep copies for 6 years is an “unnecessary burden,” said Mr. Severino. “We’ve lost whole forests from this regulation.”

Under the new proposal, health care providers would merely have to let patients know where to find their privacy policies.
 

Sharing mental health info

The rule would also ease the standard for sharing information about a patient who is in a mental health crisis, such as an exacerbation of a serious mental illness or a crisis related to a substance use disorder, including an overdose.

Currently, clinicians can choose to disclose protected health information – to a family member, a caregiver, a law enforcement official, a doctor, or an insurer – if they believe that doing so is advisable in their “professional judgment.” The rule proposes to ease that to a “good faith” belief that a disclosure would be in the best interest of the patient. In both instances, the patient can still object and block the disclosure.

As an example, HHS said that, in the case of a young adult who had experienced an overdose of opioids, a licensed health care professional could make the determination to “disclose relevant information to a parent who is involved in the patient’s treatment and who the young adult would expect, based on their relationship, to participate in or be involved with the patient’s recovery from the overdose.”

HHS is also proposing to let clinicians disclose information in cases in which an individual might be a threat to himself or others, provided the harm is “serious and reasonably foreseeable.”

Currently, information can only be disclosed if it appears there is a “serious and imminent” threat to health or safety. If an individual experienced suicidal ideation, for instance, a health care professional could notify family that the individual is at risk.
 

Fast, no-cost access

The rule also aims to make it easier for patients to get access to their own health care information quickly – within 15 days of a request – instead of the 30 days currently allowed, and sometimes at no cost.

The 30-day time frame is “a relic of a pre-Internet age that should be dispensed with,” said Mr. Severino.

Patients can also request that a treating physician get his or her records from a clinician who had previously treated the individual. The request would be fulfilled within 15 days, although extensions might be possible.

“That takes away the burden of coordination from the patient and puts it on those parties that are responsible for the actual provision of care and that are better positioned to do that coordination,” Mr. Severino said.

Health care professionals will also have to share with patients a fee schedule for records requests. However, if records are shared through a patient portal with view, download, and transmit capabilities, the provider can’t charge the patient for the time it took to upload the information into the system.

“We do not believe a patient’s personal medical record should be profit centers for providers,” Mr. Severino said.

Patients will be allowed to take photos with a smartphone of personal health information – such as an x-ray or sonogram – while receiving care.

The rule is open for public comment until mid-February. After that, it will become final in 180 days. The agency said it would not begin enforcement until 240 days after the final rule was published.

A version of this article originally appeared on Medscape.com.

The Department of Health & Human Services is proposing an overhaul of HIPAA that will make it easier to access patients’ personal health information, including the health records of patients with mental illness. The proposal would also do away with the requirement that all patients sign a notice of privacy practices.

The changes are contained in a 357-page proposed rule, which was unveiled by federal officials Dec. 10. Roger Severino, director of HHS’ Office for Civil Rights, said in a briefing that the sweeping proposal would empower patients, reduce the administrative burden for health care providers, and pave the way to better-coordinated care.

HHS estimated that the rule could save $3.2 billion over 5 years, but it’s not clear how much of that would accrue to clinical practices.

The most obvious cost-saving aspect for medical and dental practices is the proposal that practitioners would no longer have to provide and collect signed notifications of privacy practices.

“This has been a tremendous waste of time and effort and has caused massive confusion,” said Mr. Severino. He said some patients thought they were waiving privacy rights and that, in some cases, physicians refused to administer care unless patients signed the notices. “That was never the intent.”

Requiring that patients sign the form and that practices keep copies for 6 years is an “unnecessary burden,” said Mr. Severino. “We’ve lost whole forests from this regulation.”

Under the new proposal, health care providers would merely have to let patients know where to find their privacy policies.
 

Sharing mental health info

The rule would also ease the standard for sharing information about a patient who is in a mental health crisis, such as an exacerbation of a serious mental illness or a crisis related to a substance use disorder, including an overdose.

Currently, clinicians can choose to disclose protected health information – to a family member, a caregiver, a law enforcement official, a doctor, or an insurer – if they believe that doing so is advisable in their “professional judgment.” The rule proposes to ease that to a “good faith” belief that a disclosure would be in the best interest of the patient. In both instances, the patient can still object and block the disclosure.

As an example, HHS said that, in the case of a young adult who had experienced an overdose of opioids, a licensed health care professional could make the determination to “disclose relevant information to a parent who is involved in the patient’s treatment and who the young adult would expect, based on their relationship, to participate in or be involved with the patient’s recovery from the overdose.”

HHS is also proposing to let clinicians disclose information in cases in which an individual might be a threat to himself or others, provided the harm is “serious and reasonably foreseeable.”

Currently, information can only be disclosed if it appears there is a “serious and imminent” threat to health or safety. If an individual experienced suicidal ideation, for instance, a health care professional could notify family that the individual is at risk.
 

Fast, no-cost access

The rule also aims to make it easier for patients to get access to their own health care information quickly – within 15 days of a request – instead of the 30 days currently allowed, and sometimes at no cost.

The 30-day time frame is “a relic of a pre-Internet age that should be dispensed with,” said Mr. Severino.

Patients can also request that a treating physician get his or her records from a clinician who had previously treated the individual. The request would be fulfilled within 15 days, although extensions might be possible.

“That takes away the burden of coordination from the patient and puts it on those parties that are responsible for the actual provision of care and that are better positioned to do that coordination,” Mr. Severino said.

Health care professionals will also have to share with patients a fee schedule for records requests. However, if records are shared through a patient portal with view, download, and transmit capabilities, the provider can’t charge the patient for the time it took to upload the information into the system.

“We do not believe a patient’s personal medical record should be profit centers for providers,” Mr. Severino said.

Patients will be allowed to take photos with a smartphone of personal health information – such as an x-ray or sonogram – while receiving care.

The rule is open for public comment until mid-February. After that, it will become final in 180 days. The agency said it would not begin enforcement until 240 days after the final rule was published.

A version of this article originally appeared on Medscape.com.

The Department of Health & Human Services is proposing an overhaul of HIPAA that will make it easier to access patients’ personal health information, including the health records of patients with mental illness. The proposal would also do away with the requirement that all patients sign a notice of privacy practices.

The changes are contained in a 357-page proposed rule, which was unveiled by federal officials Dec. 10. Roger Severino, director of HHS’ Office for Civil Rights, said in a briefing that the sweeping proposal would empower patients, reduce the administrative burden for health care providers, and pave the way to better-coordinated care.

HHS estimated that the rule could save $3.2 billion over 5 years, but it’s not clear how much of that would accrue to clinical practices.

The most obvious cost-saving aspect for medical and dental practices is the proposal that practitioners would no longer have to provide and collect signed notifications of privacy practices.

“This has been a tremendous waste of time and effort and has caused massive confusion,” said Mr. Severino. He said some patients thought they were waiving privacy rights and that, in some cases, physicians refused to administer care unless patients signed the notices. “That was never the intent.”

Requiring that patients sign the form and that practices keep copies for 6 years is an “unnecessary burden,” said Mr. Severino. “We’ve lost whole forests from this regulation.”

Under the new proposal, health care providers would merely have to let patients know where to find their privacy policies.
 

Sharing mental health info

The rule would also ease the standard for sharing information about a patient who is in a mental health crisis, such as an exacerbation of a serious mental illness or a crisis related to a substance use disorder, including an overdose.

Currently, clinicians can choose to disclose protected health information – to a family member, a caregiver, a law enforcement official, a doctor, or an insurer – if they believe that doing so is advisable in their “professional judgment.” The rule proposes to ease that to a “good faith” belief that a disclosure would be in the best interest of the patient. In both instances, the patient can still object and block the disclosure.

As an example, HHS said that, in the case of a young adult who had experienced an overdose of opioids, a licensed health care professional could make the determination to “disclose relevant information to a parent who is involved in the patient’s treatment and who the young adult would expect, based on their relationship, to participate in or be involved with the patient’s recovery from the overdose.”

HHS is also proposing to let clinicians disclose information in cases in which an individual might be a threat to himself or others, provided the harm is “serious and reasonably foreseeable.”

Currently, information can only be disclosed if it appears there is a “serious and imminent” threat to health or safety. If an individual experienced suicidal ideation, for instance, a health care professional could notify family that the individual is at risk.
 

Fast, no-cost access

The rule also aims to make it easier for patients to get access to their own health care information quickly – within 15 days of a request – instead of the 30 days currently allowed, and sometimes at no cost.

The 30-day time frame is “a relic of a pre-Internet age that should be dispensed with,” said Mr. Severino.

Patients can also request that a treating physician get his or her records from a clinician who had previously treated the individual. The request would be fulfilled within 15 days, although extensions might be possible.

“That takes away the burden of coordination from the patient and puts it on those parties that are responsible for the actual provision of care and that are better positioned to do that coordination,” Mr. Severino said.

Health care professionals will also have to share with patients a fee schedule for records requests. However, if records are shared through a patient portal with view, download, and transmit capabilities, the provider can’t charge the patient for the time it took to upload the information into the system.

“We do not believe a patient’s personal medical record should be profit centers for providers,” Mr. Severino said.

Patients will be allowed to take photos with a smartphone of personal health information – such as an x-ray or sonogram – while receiving care.

The rule is open for public comment until mid-February. After that, it will become final in 180 days. The agency said it would not begin enforcement until 240 days after the final rule was published.

A version of this article originally appeared on Medscape.com.