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PREMM5: Updated Lynch syndrome test available
An updated Lynch syndrome (LS) prediction model improves accuracy and may be used to assess individuals who are currently unaffected by cancer. The model predicts an individual’s risk of carrying one of five known gene mutations associated with LS. It could be applied to individuals with a suspicious family history of cancer, as well as to colon cancer patients who may not have tumor immunohistochemical and microsatellite instability testing results that can spot potential LS patients based on specific tumor characteristics.
LS is linked to a 40%-80% lifetime risk of colorectal cancer and heightened risk of gynecologic cancer in women, as well as gastrointestinal, genitourinary, and additional cancers.
Addition of the PMS2 gene is important because there is some evidence that it is the most prevalent gene in LS, although it has a weaker phenotype, with cancer diagnoses at older ages and less striking family histories. Still, its higher frequency makes it an important player. “It’s a big deal. We originally thought the majority of LS was caused by MLH1 and MSH2 gene alterations, but that is no longer the case,” said lead author Fay Kastrinos, MD, MPH, director of the hereditary GI cancer risk and prevention program at New York–Presbyterian Hospital/Columbia University Medical Center.
The researchers recommend that anyone with a probability over 2.5% should be referred to evaluation for genetic testing, which could include germline genetic testing, microsatellite instability, or immunohistochemistry testing of a colorectal cancer tumor.
The new model is a successor to PRMM1,2,6, which evaluated a patient’s risk of a mutation in MLH1, MLH2, or MLH6. That model was developed from a population predominantly composed of colon cancer patients.
The researchers expanded the population for the PREMM5 model to include a total of 18,734 subjects who were evaluated for a wide range of clinical characteristics, as well as personal and family cancer history, and were tested for mutations in all five genes.
Of that population, 5% had mutations in one of the LS genes, and the model distinguished mutation carriers from noncarriers with an area under the curve of 0.81 (95% confidence interval, 0.79-0.82).
When the team applied the model to a validation cohort of 1,058 patients with colorectal cancer, it achieved a similar level of accuracy (AUC, 0.83; 95% CI, 0.75-0.92). When looking at the prediction of each specific gene, the model fared worse in predicting PMS2 mutations (AUC, 0.64; 95% CI, 0.60-0.68) than for other genes.
When applied to the PREMM5 development cohort, PREMM1,2,6 over-predicted mutation-positive status. (For MLH1, MSH2, and MSH6, it predicted a prevalence of 8.0%, compared with an observed frequency of 4.5%.)
Dr. Kastrinos stressed the potential use of the model among individuals unaffected by cancer. She noted that over 46% of the derivation cohort had no personal cancer history, only family histories of LS-associated cancers. “So, there is the potential for this model to be used in preventive health settings to assess familial cancer risk in someone who doesn’t have cancer but may be discovered to be at increased risk during a routine medical evaluation,” she said.
Gastroenterologists could also employ it with patients presenting for screening colonoscopy to assess for personal or family cancer history suggestive of LS. Patients ultimately found to have LS can be followed more closely, and close relatives can also be considered for testing. “If we can promote the identification of those with LS who are unaffected by cancer, we can make a tremendous impact in the prevention of malignancies associated with Lynch syndrome,” said Dr. Kastrinos.
Dr. Kastrinos reported having no financial disclosures.
An updated Lynch syndrome (LS) prediction model improves accuracy and may be used to assess individuals who are currently unaffected by cancer. The model predicts an individual’s risk of carrying one of five known gene mutations associated with LS. It could be applied to individuals with a suspicious family history of cancer, as well as to colon cancer patients who may not have tumor immunohistochemical and microsatellite instability testing results that can spot potential LS patients based on specific tumor characteristics.
LS is linked to a 40%-80% lifetime risk of colorectal cancer and heightened risk of gynecologic cancer in women, as well as gastrointestinal, genitourinary, and additional cancers.
Addition of the PMS2 gene is important because there is some evidence that it is the most prevalent gene in LS, although it has a weaker phenotype, with cancer diagnoses at older ages and less striking family histories. Still, its higher frequency makes it an important player. “It’s a big deal. We originally thought the majority of LS was caused by MLH1 and MSH2 gene alterations, but that is no longer the case,” said lead author Fay Kastrinos, MD, MPH, director of the hereditary GI cancer risk and prevention program at New York–Presbyterian Hospital/Columbia University Medical Center.
The researchers recommend that anyone with a probability over 2.5% should be referred to evaluation for genetic testing, which could include germline genetic testing, microsatellite instability, or immunohistochemistry testing of a colorectal cancer tumor.
The new model is a successor to PRMM1,2,6, which evaluated a patient’s risk of a mutation in MLH1, MLH2, or MLH6. That model was developed from a population predominantly composed of colon cancer patients.
The researchers expanded the population for the PREMM5 model to include a total of 18,734 subjects who were evaluated for a wide range of clinical characteristics, as well as personal and family cancer history, and were tested for mutations in all five genes.
Of that population, 5% had mutations in one of the LS genes, and the model distinguished mutation carriers from noncarriers with an area under the curve of 0.81 (95% confidence interval, 0.79-0.82).
When the team applied the model to a validation cohort of 1,058 patients with colorectal cancer, it achieved a similar level of accuracy (AUC, 0.83; 95% CI, 0.75-0.92). When looking at the prediction of each specific gene, the model fared worse in predicting PMS2 mutations (AUC, 0.64; 95% CI, 0.60-0.68) than for other genes.
When applied to the PREMM5 development cohort, PREMM1,2,6 over-predicted mutation-positive status. (For MLH1, MSH2, and MSH6, it predicted a prevalence of 8.0%, compared with an observed frequency of 4.5%.)
Dr. Kastrinos stressed the potential use of the model among individuals unaffected by cancer. She noted that over 46% of the derivation cohort had no personal cancer history, only family histories of LS-associated cancers. “So, there is the potential for this model to be used in preventive health settings to assess familial cancer risk in someone who doesn’t have cancer but may be discovered to be at increased risk during a routine medical evaluation,” she said.
Gastroenterologists could also employ it with patients presenting for screening colonoscopy to assess for personal or family cancer history suggestive of LS. Patients ultimately found to have LS can be followed more closely, and close relatives can also be considered for testing. “If we can promote the identification of those with LS who are unaffected by cancer, we can make a tremendous impact in the prevention of malignancies associated with Lynch syndrome,” said Dr. Kastrinos.
Dr. Kastrinos reported having no financial disclosures.
An updated Lynch syndrome (LS) prediction model improves accuracy and may be used to assess individuals who are currently unaffected by cancer. The model predicts an individual’s risk of carrying one of five known gene mutations associated with LS. It could be applied to individuals with a suspicious family history of cancer, as well as to colon cancer patients who may not have tumor immunohistochemical and microsatellite instability testing results that can spot potential LS patients based on specific tumor characteristics.
LS is linked to a 40%-80% lifetime risk of colorectal cancer and heightened risk of gynecologic cancer in women, as well as gastrointestinal, genitourinary, and additional cancers.
Addition of the PMS2 gene is important because there is some evidence that it is the most prevalent gene in LS, although it has a weaker phenotype, with cancer diagnoses at older ages and less striking family histories. Still, its higher frequency makes it an important player. “It’s a big deal. We originally thought the majority of LS was caused by MLH1 and MSH2 gene alterations, but that is no longer the case,” said lead author Fay Kastrinos, MD, MPH, director of the hereditary GI cancer risk and prevention program at New York–Presbyterian Hospital/Columbia University Medical Center.
The researchers recommend that anyone with a probability over 2.5% should be referred to evaluation for genetic testing, which could include germline genetic testing, microsatellite instability, or immunohistochemistry testing of a colorectal cancer tumor.
The new model is a successor to PRMM1,2,6, which evaluated a patient’s risk of a mutation in MLH1, MLH2, or MLH6. That model was developed from a population predominantly composed of colon cancer patients.
The researchers expanded the population for the PREMM5 model to include a total of 18,734 subjects who were evaluated for a wide range of clinical characteristics, as well as personal and family cancer history, and were tested for mutations in all five genes.
Of that population, 5% had mutations in one of the LS genes, and the model distinguished mutation carriers from noncarriers with an area under the curve of 0.81 (95% confidence interval, 0.79-0.82).
When the team applied the model to a validation cohort of 1,058 patients with colorectal cancer, it achieved a similar level of accuracy (AUC, 0.83; 95% CI, 0.75-0.92). When looking at the prediction of each specific gene, the model fared worse in predicting PMS2 mutations (AUC, 0.64; 95% CI, 0.60-0.68) than for other genes.
When applied to the PREMM5 development cohort, PREMM1,2,6 over-predicted mutation-positive status. (For MLH1, MSH2, and MSH6, it predicted a prevalence of 8.0%, compared with an observed frequency of 4.5%.)
Dr. Kastrinos stressed the potential use of the model among individuals unaffected by cancer. She noted that over 46% of the derivation cohort had no personal cancer history, only family histories of LS-associated cancers. “So, there is the potential for this model to be used in preventive health settings to assess familial cancer risk in someone who doesn’t have cancer but may be discovered to be at increased risk during a routine medical evaluation,” she said.
Gastroenterologists could also employ it with patients presenting for screening colonoscopy to assess for personal or family cancer history suggestive of LS. Patients ultimately found to have LS can be followed more closely, and close relatives can also be considered for testing. “If we can promote the identification of those with LS who are unaffected by cancer, we can make a tremendous impact in the prevention of malignancies associated with Lynch syndrome,” said Dr. Kastrinos.
Dr. Kastrinos reported having no financial disclosures.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: The researchers recommend testing for patients who score a probability greater than or equal to 2.5%.
Major finding: The model distinguished carriers from noncarriers with an AUC of 0.81.
Data source: Development cohort of 18,734 and validation cohort of 1,058.
Disclosures: No source of funding was disclosed. Dr. Kastrinos reported having no financial disclosures.
Elderly black individuals at higher risk of colorectal cancer
Elderly black patients on Medicare are at a 31% higher risk for colorectal cancer (CRC) than white patients, according to a study done by Stacey A. Fedewa, PhD, MPH, and her colleagues at the American Cancer Society.
There were 2,735 cases of interval CRC identified between 2002 and 2011 for this study. The patients studied were between 66 and 75 years of age and were all enrolled in Medicare. A higher proportion of black individuals, 52.8%, received a colonoscopy from physicians with a lower polyp detection rate (PDR, a proxy for adenoma detection rate), compared with whites at 46.2%. The PDR, the number of patients in whom a polypectomy is performed divided by the number of colonoscopies performed in a 5-year period, is significantly associated with interval CRC risk (Ann Intern Med. 2017. doi: 10.7326/M16-1154).
Interval CRC, defined as cancer that develops after a negative result on colonoscopy but before the next recommended test, accounts for 3%-8% of CRC cases in the United States. These cases of CRC develop in certain populations because they were missed at the time of screening or between recommended screenings or surveillance intervals.
Results showed that the probability of interval CRC by the end of follow-up was 7.1% in blacks, 5.8% in whites, 4.4% in Hispanics, and 3.8% in Asians. Of the 79,396 Medicare patients that met enrollment criteria, 61,433 were included in the study. The average age of index colonoscopy was 70 years, and 2,735 cases of interval CRC were identified.
“Future studies examining this issue are warranted, given the higher overall risk for interval CRC in black populations as well as the larger disease burden in this group,” Dr. Fedewa said.
Medicare patient data were gathered from the National Cancer Institute’s Surveillance, Epidemiology, and End Results program (SEER), a data collection of 18 cancer registries across the United States. Claims data were used to identify receipt and dates of patient colonoscopies and polypectomies, as well as the PDR of administering physicians. Data from SEER was used to identify cases of interval CRC. Medicare Enrollment data were used to determine patients’ ethnicities.
The primary exposures were ethnicity and physician PDR, a relative measure of colonoscopy quality. Ethnicities were categorized as non-Hispanic white, black, Hispanic, Asian, and other. Patients were followed until they died, were no longer enrolled in Medicare, or experienced interval CRC defined as a first case of primary invasive CRC diagnosed 6-59 months after the colonoscopy.
Elderly black patients on Medicare are at a 31% higher risk for colorectal cancer (CRC) than white patients, according to a study done by Stacey A. Fedewa, PhD, MPH, and her colleagues at the American Cancer Society.
There were 2,735 cases of interval CRC identified between 2002 and 2011 for this study. The patients studied were between 66 and 75 years of age and were all enrolled in Medicare. A higher proportion of black individuals, 52.8%, received a colonoscopy from physicians with a lower polyp detection rate (PDR, a proxy for adenoma detection rate), compared with whites at 46.2%. The PDR, the number of patients in whom a polypectomy is performed divided by the number of colonoscopies performed in a 5-year period, is significantly associated with interval CRC risk (Ann Intern Med. 2017. doi: 10.7326/M16-1154).
Interval CRC, defined as cancer that develops after a negative result on colonoscopy but before the next recommended test, accounts for 3%-8% of CRC cases in the United States. These cases of CRC develop in certain populations because they were missed at the time of screening or between recommended screenings or surveillance intervals.
Results showed that the probability of interval CRC by the end of follow-up was 7.1% in blacks, 5.8% in whites, 4.4% in Hispanics, and 3.8% in Asians. Of the 79,396 Medicare patients that met enrollment criteria, 61,433 were included in the study. The average age of index colonoscopy was 70 years, and 2,735 cases of interval CRC were identified.
“Future studies examining this issue are warranted, given the higher overall risk for interval CRC in black populations as well as the larger disease burden in this group,” Dr. Fedewa said.
Medicare patient data were gathered from the National Cancer Institute’s Surveillance, Epidemiology, and End Results program (SEER), a data collection of 18 cancer registries across the United States. Claims data were used to identify receipt and dates of patient colonoscopies and polypectomies, as well as the PDR of administering physicians. Data from SEER was used to identify cases of interval CRC. Medicare Enrollment data were used to determine patients’ ethnicities.
The primary exposures were ethnicity and physician PDR, a relative measure of colonoscopy quality. Ethnicities were categorized as non-Hispanic white, black, Hispanic, Asian, and other. Patients were followed until they died, were no longer enrolled in Medicare, or experienced interval CRC defined as a first case of primary invasive CRC diagnosed 6-59 months after the colonoscopy.
Elderly black patients on Medicare are at a 31% higher risk for colorectal cancer (CRC) than white patients, according to a study done by Stacey A. Fedewa, PhD, MPH, and her colleagues at the American Cancer Society.
There were 2,735 cases of interval CRC identified between 2002 and 2011 for this study. The patients studied were between 66 and 75 years of age and were all enrolled in Medicare. A higher proportion of black individuals, 52.8%, received a colonoscopy from physicians with a lower polyp detection rate (PDR, a proxy for adenoma detection rate), compared with whites at 46.2%. The PDR, the number of patients in whom a polypectomy is performed divided by the number of colonoscopies performed in a 5-year period, is significantly associated with interval CRC risk (Ann Intern Med. 2017. doi: 10.7326/M16-1154).
Interval CRC, defined as cancer that develops after a negative result on colonoscopy but before the next recommended test, accounts for 3%-8% of CRC cases in the United States. These cases of CRC develop in certain populations because they were missed at the time of screening or between recommended screenings or surveillance intervals.
Results showed that the probability of interval CRC by the end of follow-up was 7.1% in blacks, 5.8% in whites, 4.4% in Hispanics, and 3.8% in Asians. Of the 79,396 Medicare patients that met enrollment criteria, 61,433 were included in the study. The average age of index colonoscopy was 70 years, and 2,735 cases of interval CRC were identified.
“Future studies examining this issue are warranted, given the higher overall risk for interval CRC in black populations as well as the larger disease burden in this group,” Dr. Fedewa said.
Medicare patient data were gathered from the National Cancer Institute’s Surveillance, Epidemiology, and End Results program (SEER), a data collection of 18 cancer registries across the United States. Claims data were used to identify receipt and dates of patient colonoscopies and polypectomies, as well as the PDR of administering physicians. Data from SEER was used to identify cases of interval CRC. Medicare Enrollment data were used to determine patients’ ethnicities.
The primary exposures were ethnicity and physician PDR, a relative measure of colonoscopy quality. Ethnicities were categorized as non-Hispanic white, black, Hispanic, Asian, and other. Patients were followed until they died, were no longer enrolled in Medicare, or experienced interval CRC defined as a first case of primary invasive CRC diagnosed 6-59 months after the colonoscopy.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point:
Major finding: The risk of interval colorectal cancer was 7.1% in blacks, 5.8% in whites, 4.4% in Hispanics, and 3.8% in Asians.
Data source: A population-based cohort study involving 2,735 cases of interval colorectal cancer identified between 2002 and 2011.
Disclosures: The study was funded by the American Cancer Society and approved by the Institutional review board at Emory University. Data analysis for this research was supported by the American Cancer Society. Dr. Doubeni’s contribution was supported by an award from the United States National Cancer Institute of the National Institutes of Health. Authors have declared no conflicts of interest.
Republicans race the clock on health care, but the calendar is not helping
Back in January, Republicans boasted they would deliver a “repeal and replace” bill for the Affordable Care Act to President Donald Trump’s desk by the end of the month.
In the interim, that bravado has faded as their efforts stalled and they found out how complicated undoing a major law can be. With summer just around the corner, and most of official Washington swept up in scandals surrounding Trump, the health overhaul delays are starting to back up the rest of the 2018 agenda.
One of the immediate casualties is the renewal of the Children’s Health Insurance Program. CHIP covers just under 9 million children in low- and moderate-income families, at a cost of about $15 billion a year.
Funding for CHIP does not technically end until Sept. 30, but it is already too late for states to plan their budgets effectively. They needed to know about future funding while their legislatures were still in session, but, according to the National Conference of State Legislatures, the local lawmakers have already adjourned for the year in more than half of the states.
“If [Congress] had wanted to do what states needed with respect to CHIP, it would be done already,” said Joan Alker of the Georgetown Center for Children and Families.
“Certainty and predictability [are] important,” agreed Matt Salo, executive director of the National Association of Medicaid Directors. “If we don’t know that the money is going to be there, we have to start planning to dismantle things early, and that has a real human toll.”
In a March letter urging prompt action, the Medicaid directors noted that while the end of September might seem far off, “as the program nears the end of its congressional funding, states will be required to notify current CHIP beneficiaries of the termination of their coverage. This process may be required to begin as early as July in some states.”
CHIP has long been a bipartisan program – one of its original sponsors is Sen. Orrin Hatch (R-Utah), who chairs the Finance Committee that oversees it. It was created in 1997, and last reauthorized in 2015, for 2 years. But a Finance hearing that was intended to launch the effort to renew the program was abruptly canceled this month, amid suggestions that Republicans might want to hold the program’s renewal hostage to force Democrats and moderate Republicans to make concessions on the bill to replace the Affordable Care Act.
“It’s a very difficult time with respect to children’s coverage,” said Ms. Alker. Not only is the future of CHIP in doubt, but also the House-passed health bill would make major cuts to the Medicaid program, and many states have chosen to roll CHIP into the Medicaid program.”
“We’ve just achieved a historic level in coverage of kids,” she said, referring to a new report finding that more than 93% of eligible U.S. children now have health insurance under CHIP. “Now all three legs of that coverage stool – CHIP, Medicaid, and ACA – are up for grabs.”
But it’s not just CHIP at risk because of the congested congressional calendar. Congress also can’t do the tax bill Republicans badly want until lawmakers wrap up the health bill.
That is because Republicans want to use the same budget procedure, called reconciliation, for both bills. That procedure forbids a filibuster in the Senate and allows passage with a simple majority.
There’s a catch, though. The health bill’s reconciliation instructions were part of the fiscal 2017 budget resolution, which Congress passed in January. Lawmakers would need to adopt a fiscal 2018 budget resolution in order to use the same fast-track procedures for their tax changes.
And they cannot do both at the same time. “Once Congress adopts a new budget resolution for fiscal year 2018,” said Ed Lorenzen, a budget-process expert at the Committee for a Responsible Federal Budget, that new resolution “supplants the fiscal year 2017 resolution and the reconciliation instructions in the fiscal year 2017 budget are moot.”
That means if Congress wanted to continue with the health bill, it would need 60 votes in the Senate, not a simple majority.
There is, however, a loophole of sorts. Congress “can start the next budget resolution before they finish health care,” said Mr. Lorenzen. “They just can’t finish the new budget resolution until they finish health care.”
So the House and Senate could each pass its own separate budget blueprint, and even meet to come to a consensus on its final product. But they cannot take the last step of the process – with each approving a conference report or identical resolutions – until the health bill is done or given up for dead. They could also start work on a tax plan, although, again, they could not take the bill to the floor of the Senate until they finish health care and the new budget resolution.
At least that’s what most budget experts and lawmakers assume. “There’s no precedent to go on,” said Mr. Lorenzen, because no budget reconciliation bill has taken Congress this far into a fiscal year. “So nobody really knows.”
Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.
Back in January, Republicans boasted they would deliver a “repeal and replace” bill for the Affordable Care Act to President Donald Trump’s desk by the end of the month.
In the interim, that bravado has faded as their efforts stalled and they found out how complicated undoing a major law can be. With summer just around the corner, and most of official Washington swept up in scandals surrounding Trump, the health overhaul delays are starting to back up the rest of the 2018 agenda.
One of the immediate casualties is the renewal of the Children’s Health Insurance Program. CHIP covers just under 9 million children in low- and moderate-income families, at a cost of about $15 billion a year.
Funding for CHIP does not technically end until Sept. 30, but it is already too late for states to plan their budgets effectively. They needed to know about future funding while their legislatures were still in session, but, according to the National Conference of State Legislatures, the local lawmakers have already adjourned for the year in more than half of the states.
“If [Congress] had wanted to do what states needed with respect to CHIP, it would be done already,” said Joan Alker of the Georgetown Center for Children and Families.
“Certainty and predictability [are] important,” agreed Matt Salo, executive director of the National Association of Medicaid Directors. “If we don’t know that the money is going to be there, we have to start planning to dismantle things early, and that has a real human toll.”
In a March letter urging prompt action, the Medicaid directors noted that while the end of September might seem far off, “as the program nears the end of its congressional funding, states will be required to notify current CHIP beneficiaries of the termination of their coverage. This process may be required to begin as early as July in some states.”
CHIP has long been a bipartisan program – one of its original sponsors is Sen. Orrin Hatch (R-Utah), who chairs the Finance Committee that oversees it. It was created in 1997, and last reauthorized in 2015, for 2 years. But a Finance hearing that was intended to launch the effort to renew the program was abruptly canceled this month, amid suggestions that Republicans might want to hold the program’s renewal hostage to force Democrats and moderate Republicans to make concessions on the bill to replace the Affordable Care Act.
“It’s a very difficult time with respect to children’s coverage,” said Ms. Alker. Not only is the future of CHIP in doubt, but also the House-passed health bill would make major cuts to the Medicaid program, and many states have chosen to roll CHIP into the Medicaid program.”
“We’ve just achieved a historic level in coverage of kids,” she said, referring to a new report finding that more than 93% of eligible U.S. children now have health insurance under CHIP. “Now all three legs of that coverage stool – CHIP, Medicaid, and ACA – are up for grabs.”
But it’s not just CHIP at risk because of the congested congressional calendar. Congress also can’t do the tax bill Republicans badly want until lawmakers wrap up the health bill.
That is because Republicans want to use the same budget procedure, called reconciliation, for both bills. That procedure forbids a filibuster in the Senate and allows passage with a simple majority.
There’s a catch, though. The health bill’s reconciliation instructions were part of the fiscal 2017 budget resolution, which Congress passed in January. Lawmakers would need to adopt a fiscal 2018 budget resolution in order to use the same fast-track procedures for their tax changes.
And they cannot do both at the same time. “Once Congress adopts a new budget resolution for fiscal year 2018,” said Ed Lorenzen, a budget-process expert at the Committee for a Responsible Federal Budget, that new resolution “supplants the fiscal year 2017 resolution and the reconciliation instructions in the fiscal year 2017 budget are moot.”
That means if Congress wanted to continue with the health bill, it would need 60 votes in the Senate, not a simple majority.
There is, however, a loophole of sorts. Congress “can start the next budget resolution before they finish health care,” said Mr. Lorenzen. “They just can’t finish the new budget resolution until they finish health care.”
So the House and Senate could each pass its own separate budget blueprint, and even meet to come to a consensus on its final product. But they cannot take the last step of the process – with each approving a conference report or identical resolutions – until the health bill is done or given up for dead. They could also start work on a tax plan, although, again, they could not take the bill to the floor of the Senate until they finish health care and the new budget resolution.
At least that’s what most budget experts and lawmakers assume. “There’s no precedent to go on,” said Mr. Lorenzen, because no budget reconciliation bill has taken Congress this far into a fiscal year. “So nobody really knows.”
Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.
Back in January, Republicans boasted they would deliver a “repeal and replace” bill for the Affordable Care Act to President Donald Trump’s desk by the end of the month.
In the interim, that bravado has faded as their efforts stalled and they found out how complicated undoing a major law can be. With summer just around the corner, and most of official Washington swept up in scandals surrounding Trump, the health overhaul delays are starting to back up the rest of the 2018 agenda.
One of the immediate casualties is the renewal of the Children’s Health Insurance Program. CHIP covers just under 9 million children in low- and moderate-income families, at a cost of about $15 billion a year.
Funding for CHIP does not technically end until Sept. 30, but it is already too late for states to plan their budgets effectively. They needed to know about future funding while their legislatures were still in session, but, according to the National Conference of State Legislatures, the local lawmakers have already adjourned for the year in more than half of the states.
“If [Congress] had wanted to do what states needed with respect to CHIP, it would be done already,” said Joan Alker of the Georgetown Center for Children and Families.
“Certainty and predictability [are] important,” agreed Matt Salo, executive director of the National Association of Medicaid Directors. “If we don’t know that the money is going to be there, we have to start planning to dismantle things early, and that has a real human toll.”
In a March letter urging prompt action, the Medicaid directors noted that while the end of September might seem far off, “as the program nears the end of its congressional funding, states will be required to notify current CHIP beneficiaries of the termination of their coverage. This process may be required to begin as early as July in some states.”
CHIP has long been a bipartisan program – one of its original sponsors is Sen. Orrin Hatch (R-Utah), who chairs the Finance Committee that oversees it. It was created in 1997, and last reauthorized in 2015, for 2 years. But a Finance hearing that was intended to launch the effort to renew the program was abruptly canceled this month, amid suggestions that Republicans might want to hold the program’s renewal hostage to force Democrats and moderate Republicans to make concessions on the bill to replace the Affordable Care Act.
“It’s a very difficult time with respect to children’s coverage,” said Ms. Alker. Not only is the future of CHIP in doubt, but also the House-passed health bill would make major cuts to the Medicaid program, and many states have chosen to roll CHIP into the Medicaid program.”
“We’ve just achieved a historic level in coverage of kids,” she said, referring to a new report finding that more than 93% of eligible U.S. children now have health insurance under CHIP. “Now all three legs of that coverage stool – CHIP, Medicaid, and ACA – are up for grabs.”
But it’s not just CHIP at risk because of the congested congressional calendar. Congress also can’t do the tax bill Republicans badly want until lawmakers wrap up the health bill.
That is because Republicans want to use the same budget procedure, called reconciliation, for both bills. That procedure forbids a filibuster in the Senate and allows passage with a simple majority.
There’s a catch, though. The health bill’s reconciliation instructions were part of the fiscal 2017 budget resolution, which Congress passed in January. Lawmakers would need to adopt a fiscal 2018 budget resolution in order to use the same fast-track procedures for their tax changes.
And they cannot do both at the same time. “Once Congress adopts a new budget resolution for fiscal year 2018,” said Ed Lorenzen, a budget-process expert at the Committee for a Responsible Federal Budget, that new resolution “supplants the fiscal year 2017 resolution and the reconciliation instructions in the fiscal year 2017 budget are moot.”
That means if Congress wanted to continue with the health bill, it would need 60 votes in the Senate, not a simple majority.
There is, however, a loophole of sorts. Congress “can start the next budget resolution before they finish health care,” said Mr. Lorenzen. “They just can’t finish the new budget resolution until they finish health care.”
So the House and Senate could each pass its own separate budget blueprint, and even meet to come to a consensus on its final product. But they cannot take the last step of the process – with each approving a conference report or identical resolutions – until the health bill is done or given up for dead. They could also start work on a tax plan, although, again, they could not take the bill to the floor of the Senate until they finish health care and the new budget resolution.
At least that’s what most budget experts and lawmakers assume. “There’s no precedent to go on,” said Mr. Lorenzen, because no budget reconciliation bill has taken Congress this far into a fiscal year. “So nobody really knows.”
Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.
HM17 plenaries: Hospital medicine leading health care shift to value, quality
LAS VEGAS – The path to improved health care in the U.S. may never be straight – and it certainly won’t be easy – but the three plenary speakers at HM17 think its destination is pretty clear: a system that increasingly rewards quality care delivered at lower costs.
And the three experts agreed that there may be “no finer group” than hospitalists to continue leading the charge.
Hospitalists “have been at the center of change, not only in building a new field and showing us that medicine doesn’t have to be the way it always was,” said Karen DeSalvo, MD, MPH, MSc, former acting assistant secretary for health in the U.S. Department of Health and Human Services. “You have been at the forefront of seeing that we’re getting better value out of our health care system.”
Dr. DeSalvo believes HM’s scope of practice must evolve to include a focus on social determinants – such as economic stability, neighborhood and physical environment, education, and access to healthy options for food – because they have “direct relationships with mortality and morbidity and cost.”
In other words, Dr. DeSalvo wondered aloud, what good is treating a grandmother’s heart failure over and over if she’s always going to return to the hospital because her home, her neighborhood, or her finances mean she is unable to prevent recurring issues?
“If you listen to the hoof-beats that are coming, there is definitely a financial imprimatur to do this,” Dr. DeSalvo said. “There is going to be an expectation from public and private payers... that we are going to be taking into account and addressing social factors. Just look at the data from the people of this country – they are shouting loudly to you that they need help.”
“I can tell you our system still does not have a highly reliable, whole health system for those children and their families,” he said. “Every weekend, I have a family that I can’t discharge because they don’t have the social and home-based supports for them to go home. So they literally sit in the hospital until Monday. That makes no sense for our overall health system.”
Dr. Conway assured attendees that health system transformation is a bipartisan ideal and that for all the tumult in Washington, the progress of testing new payment- and service-delivery models will move forward.
The work “on value, the work on accountability, the work on bundled payments... will continue and will continue to be important to you and the patients you serve,” he said.
Robert Wachter, MD, MHM, concluded the meeting – as is tradition – by telling hospitalists the field remains positioned to take the lead for hospital transformation. And technology, despite its myriad frustrations, is still the tool that will get the field there.
“Digital is really important here, because it becomes an enabler for those stakeholders who care about what we do to measure what we do, and our ability to change what we do in a far more robust way than we could ever do before, if we get our acts together,” Dr. Wachter said. “We’re well past the time where you can nibble around the edges here, you can get this done with little mini projects. You really have to remake your whole delivery system, the way you do your work in order to succeed in this environment.”
Dr. Wachter agreed that social determinants must be addressed. He said HM might do better to partner with folks handling those issues, rather than tackling them head on. Instead, HM needs to be “focusing on the right things” amid mounting pressures from digitization, consolidation of everything from health systems to insurance companies to HM companies, and the gravitation toward population health.
“We have successfully positioned ourselves as the people who are leaders in this work,” Dr. Wachter said, “and it is increasingly important that we continue to do that as we go forward.”
LAS VEGAS – The path to improved health care in the U.S. may never be straight – and it certainly won’t be easy – but the three plenary speakers at HM17 think its destination is pretty clear: a system that increasingly rewards quality care delivered at lower costs.
And the three experts agreed that there may be “no finer group” than hospitalists to continue leading the charge.
Hospitalists “have been at the center of change, not only in building a new field and showing us that medicine doesn’t have to be the way it always was,” said Karen DeSalvo, MD, MPH, MSc, former acting assistant secretary for health in the U.S. Department of Health and Human Services. “You have been at the forefront of seeing that we’re getting better value out of our health care system.”
Dr. DeSalvo believes HM’s scope of practice must evolve to include a focus on social determinants – such as economic stability, neighborhood and physical environment, education, and access to healthy options for food – because they have “direct relationships with mortality and morbidity and cost.”
In other words, Dr. DeSalvo wondered aloud, what good is treating a grandmother’s heart failure over and over if she’s always going to return to the hospital because her home, her neighborhood, or her finances mean she is unable to prevent recurring issues?
“If you listen to the hoof-beats that are coming, there is definitely a financial imprimatur to do this,” Dr. DeSalvo said. “There is going to be an expectation from public and private payers... that we are going to be taking into account and addressing social factors. Just look at the data from the people of this country – they are shouting loudly to you that they need help.”
“I can tell you our system still does not have a highly reliable, whole health system for those children and their families,” he said. “Every weekend, I have a family that I can’t discharge because they don’t have the social and home-based supports for them to go home. So they literally sit in the hospital until Monday. That makes no sense for our overall health system.”
Dr. Conway assured attendees that health system transformation is a bipartisan ideal and that for all the tumult in Washington, the progress of testing new payment- and service-delivery models will move forward.
The work “on value, the work on accountability, the work on bundled payments... will continue and will continue to be important to you and the patients you serve,” he said.
Robert Wachter, MD, MHM, concluded the meeting – as is tradition – by telling hospitalists the field remains positioned to take the lead for hospital transformation. And technology, despite its myriad frustrations, is still the tool that will get the field there.
“Digital is really important here, because it becomes an enabler for those stakeholders who care about what we do to measure what we do, and our ability to change what we do in a far more robust way than we could ever do before, if we get our acts together,” Dr. Wachter said. “We’re well past the time where you can nibble around the edges here, you can get this done with little mini projects. You really have to remake your whole delivery system, the way you do your work in order to succeed in this environment.”
Dr. Wachter agreed that social determinants must be addressed. He said HM might do better to partner with folks handling those issues, rather than tackling them head on. Instead, HM needs to be “focusing on the right things” amid mounting pressures from digitization, consolidation of everything from health systems to insurance companies to HM companies, and the gravitation toward population health.
“We have successfully positioned ourselves as the people who are leaders in this work,” Dr. Wachter said, “and it is increasingly important that we continue to do that as we go forward.”
LAS VEGAS – The path to improved health care in the U.S. may never be straight – and it certainly won’t be easy – but the three plenary speakers at HM17 think its destination is pretty clear: a system that increasingly rewards quality care delivered at lower costs.
And the three experts agreed that there may be “no finer group” than hospitalists to continue leading the charge.
Hospitalists “have been at the center of change, not only in building a new field and showing us that medicine doesn’t have to be the way it always was,” said Karen DeSalvo, MD, MPH, MSc, former acting assistant secretary for health in the U.S. Department of Health and Human Services. “You have been at the forefront of seeing that we’re getting better value out of our health care system.”
Dr. DeSalvo believes HM’s scope of practice must evolve to include a focus on social determinants – such as economic stability, neighborhood and physical environment, education, and access to healthy options for food – because they have “direct relationships with mortality and morbidity and cost.”
In other words, Dr. DeSalvo wondered aloud, what good is treating a grandmother’s heart failure over and over if she’s always going to return to the hospital because her home, her neighborhood, or her finances mean she is unable to prevent recurring issues?
“If you listen to the hoof-beats that are coming, there is definitely a financial imprimatur to do this,” Dr. DeSalvo said. “There is going to be an expectation from public and private payers... that we are going to be taking into account and addressing social factors. Just look at the data from the people of this country – they are shouting loudly to you that they need help.”
“I can tell you our system still does not have a highly reliable, whole health system for those children and their families,” he said. “Every weekend, I have a family that I can’t discharge because they don’t have the social and home-based supports for them to go home. So they literally sit in the hospital until Monday. That makes no sense for our overall health system.”
Dr. Conway assured attendees that health system transformation is a bipartisan ideal and that for all the tumult in Washington, the progress of testing new payment- and service-delivery models will move forward.
The work “on value, the work on accountability, the work on bundled payments... will continue and will continue to be important to you and the patients you serve,” he said.
Robert Wachter, MD, MHM, concluded the meeting – as is tradition – by telling hospitalists the field remains positioned to take the lead for hospital transformation. And technology, despite its myriad frustrations, is still the tool that will get the field there.
“Digital is really important here, because it becomes an enabler for those stakeholders who care about what we do to measure what we do, and our ability to change what we do in a far more robust way than we could ever do before, if we get our acts together,” Dr. Wachter said. “We’re well past the time where you can nibble around the edges here, you can get this done with little mini projects. You really have to remake your whole delivery system, the way you do your work in order to succeed in this environment.”
Dr. Wachter agreed that social determinants must be addressed. He said HM might do better to partner with folks handling those issues, rather than tackling them head on. Instead, HM needs to be “focusing on the right things” amid mounting pressures from digitization, consolidation of everything from health systems to insurance companies to HM companies, and the gravitation toward population health.
“We have successfully positioned ourselves as the people who are leaders in this work,” Dr. Wachter said, “and it is increasingly important that we continue to do that as we go forward.”
Recurrent acute pancreatitis significantly impairs both mental and physical quality of life
CHICAGO – Despite its intermittent and unpredictable nature, recurrent acute pancreatitis exacts a significant toll on patients’ physical and mental quality of life.
It is well-known that patients with chronic pancreatitis suffer physically and emotionally. However, the same understanding has not been engendered for those who experience recurrent acute pancreatitis (RAP), Gregory A. Cote, MD, said at the annual Digestive Disease Week®. Sporadic episodes of acute pancreatitis may cause persistent declines in quality of life.
“RAP clearly leads to a significant reduction in physical and mental quality of life, despite its erratic and sporadic nature,” Dr. Cote said. “Smoking and self-reported disability are very important drivers of these reductions, and a concomitant diagnosis of diabetes exacerbates that even further.”
To explore RAP’s impact on mental and physical quality of life, Dr. Cote examined data from three related cross-sectional North American Pancreatitis Studies (NAPS): the NAPS2, NAPS2-CV (Continuation and Validation), and NAPS2-AS (Ancillary Study).
These studies comprised 2,619 subjects who were enrolled at 27 U.S. sites from 2000 to 2014. Both patients and their physicians completed detailed baseline questionnaires that included personal and family history, risk factors, symptoms, and the 12-Item Short Form Health Survey (SF-12), a detailed quality of life measure.
A score of 50 is the mean for the U.S. general population, and a difference of 3 points or more is considered clinically relevant, Dr. Cote noted.
He parsed the cohort into three groups: those with RAP (508), those with chronic pancreatitis (1,086), and a reference group of healthy controls who were also in the database (1,025).
Some significant between-group differences were immediately obvious, Dr. Cote said. Patients with RAP were significantly younger than both chronic pancreatitis patients (CP) and controls (45 vs. 51 and 49 years, respectively). They also experienced their first bout of acute pancreatitis sooner than CP patients became symptomatic (40 vs. 44 years). Gender was a factor as well: CP patients were more often men (55% vs. 46%).
The pattern of alcohol use between the groups was difficult to interpret, he said. About one-quarter of RAP patients abstained, another fourth were light drinkers, and another fourth moderate drinkers – 12% drank heavily and 7% very heavily. In contrast, frequent drinking was more common among CP patients, with 12% reporting that they drank heavily and 33% very heavily.
CP patients were significantly more likely to be smokers, with 75% reporting current or past tobacco use, compared with 55% of RAP patients. More RAP patients reported never smoking (44% vs. 25%).
RAP patients fell between CP patients and controls in terms of medical comorbidities, including diabetes, renal disease or kidney failure, heart disease, and liver disease.
On the SF-12 physical component section, RAP patients scored a mean of 41 points – significantly worse than controls (51) but significantly better than CP patients (37). The findings were similar for the mental component score: RAP patients scored a mean of 45, compared with 52 in controls and 43 in CP patients.
Dr. Cote performed a multivariate analysis that controlled for age, sex, tobacco and alcohol use, and diabetes. Again, he found that, compared with controls, RAP was associated with significantly reduced scores on both the physical and mental components (mean 8.5 and 6.5 points, respectively).
“The magnitude of reduction was even greater for chronic pancreatitis, with an 11-point reduction on the physical component score and a 7.6-point reduction on the mental component score.
He then sought to identify which clinical characteristics most contributed to this impact on quality of life.
On the physical component score, several were significant, including female sex, which was associated with a 4.4-point decrease; prior pancreatic surgery (–3.3); endocrine insufficiency (–4.6); past smoking (–2.5); current smoking (–3.6); and self-reported physical disability (–9.5).
The mental component score breakdown echoed some of these. Self-reported disability exerted the largest impact, bringing the mental score down by a mean of 5.4 points. Other significant factors were smoking less than a pack a day (–2.5) and smoking more than a pack a day (–4.6). Any suspicion of chronic pancreatitis by the treating physician was associated with a 2.9-point decrease on the score.
“Our findings stress that this is not a disease that can be followed conservatively. We have to investigate interventions that will attenuate it, not only because these patients may go on to develop chronic pancreatitis but because, in their current state, most are experiencing significant reductions in their quality of life.”
Dr Cote had no financial disclosures.
[email protected]
On Twitter @alz_gal
CHICAGO – Despite its intermittent and unpredictable nature, recurrent acute pancreatitis exacts a significant toll on patients’ physical and mental quality of life.
It is well-known that patients with chronic pancreatitis suffer physically and emotionally. However, the same understanding has not been engendered for those who experience recurrent acute pancreatitis (RAP), Gregory A. Cote, MD, said at the annual Digestive Disease Week®. Sporadic episodes of acute pancreatitis may cause persistent declines in quality of life.
“RAP clearly leads to a significant reduction in physical and mental quality of life, despite its erratic and sporadic nature,” Dr. Cote said. “Smoking and self-reported disability are very important drivers of these reductions, and a concomitant diagnosis of diabetes exacerbates that even further.”
To explore RAP’s impact on mental and physical quality of life, Dr. Cote examined data from three related cross-sectional North American Pancreatitis Studies (NAPS): the NAPS2, NAPS2-CV (Continuation and Validation), and NAPS2-AS (Ancillary Study).
These studies comprised 2,619 subjects who were enrolled at 27 U.S. sites from 2000 to 2014. Both patients and their physicians completed detailed baseline questionnaires that included personal and family history, risk factors, symptoms, and the 12-Item Short Form Health Survey (SF-12), a detailed quality of life measure.
A score of 50 is the mean for the U.S. general population, and a difference of 3 points or more is considered clinically relevant, Dr. Cote noted.
He parsed the cohort into three groups: those with RAP (508), those with chronic pancreatitis (1,086), and a reference group of healthy controls who were also in the database (1,025).
Some significant between-group differences were immediately obvious, Dr. Cote said. Patients with RAP were significantly younger than both chronic pancreatitis patients (CP) and controls (45 vs. 51 and 49 years, respectively). They also experienced their first bout of acute pancreatitis sooner than CP patients became symptomatic (40 vs. 44 years). Gender was a factor as well: CP patients were more often men (55% vs. 46%).
The pattern of alcohol use between the groups was difficult to interpret, he said. About one-quarter of RAP patients abstained, another fourth were light drinkers, and another fourth moderate drinkers – 12% drank heavily and 7% very heavily. In contrast, frequent drinking was more common among CP patients, with 12% reporting that they drank heavily and 33% very heavily.
CP patients were significantly more likely to be smokers, with 75% reporting current or past tobacco use, compared with 55% of RAP patients. More RAP patients reported never smoking (44% vs. 25%).
RAP patients fell between CP patients and controls in terms of medical comorbidities, including diabetes, renal disease or kidney failure, heart disease, and liver disease.
On the SF-12 physical component section, RAP patients scored a mean of 41 points – significantly worse than controls (51) but significantly better than CP patients (37). The findings were similar for the mental component score: RAP patients scored a mean of 45, compared with 52 in controls and 43 in CP patients.
Dr. Cote performed a multivariate analysis that controlled for age, sex, tobacco and alcohol use, and diabetes. Again, he found that, compared with controls, RAP was associated with significantly reduced scores on both the physical and mental components (mean 8.5 and 6.5 points, respectively).
“The magnitude of reduction was even greater for chronic pancreatitis, with an 11-point reduction on the physical component score and a 7.6-point reduction on the mental component score.
He then sought to identify which clinical characteristics most contributed to this impact on quality of life.
On the physical component score, several were significant, including female sex, which was associated with a 4.4-point decrease; prior pancreatic surgery (–3.3); endocrine insufficiency (–4.6); past smoking (–2.5); current smoking (–3.6); and self-reported physical disability (–9.5).
The mental component score breakdown echoed some of these. Self-reported disability exerted the largest impact, bringing the mental score down by a mean of 5.4 points. Other significant factors were smoking less than a pack a day (–2.5) and smoking more than a pack a day (–4.6). Any suspicion of chronic pancreatitis by the treating physician was associated with a 2.9-point decrease on the score.
“Our findings stress that this is not a disease that can be followed conservatively. We have to investigate interventions that will attenuate it, not only because these patients may go on to develop chronic pancreatitis but because, in their current state, most are experiencing significant reductions in their quality of life.”
Dr Cote had no financial disclosures.
[email protected]
On Twitter @alz_gal
CHICAGO – Despite its intermittent and unpredictable nature, recurrent acute pancreatitis exacts a significant toll on patients’ physical and mental quality of life.
It is well-known that patients with chronic pancreatitis suffer physically and emotionally. However, the same understanding has not been engendered for those who experience recurrent acute pancreatitis (RAP), Gregory A. Cote, MD, said at the annual Digestive Disease Week®. Sporadic episodes of acute pancreatitis may cause persistent declines in quality of life.
“RAP clearly leads to a significant reduction in physical and mental quality of life, despite its erratic and sporadic nature,” Dr. Cote said. “Smoking and self-reported disability are very important drivers of these reductions, and a concomitant diagnosis of diabetes exacerbates that even further.”
To explore RAP’s impact on mental and physical quality of life, Dr. Cote examined data from three related cross-sectional North American Pancreatitis Studies (NAPS): the NAPS2, NAPS2-CV (Continuation and Validation), and NAPS2-AS (Ancillary Study).
These studies comprised 2,619 subjects who were enrolled at 27 U.S. sites from 2000 to 2014. Both patients and their physicians completed detailed baseline questionnaires that included personal and family history, risk factors, symptoms, and the 12-Item Short Form Health Survey (SF-12), a detailed quality of life measure.
A score of 50 is the mean for the U.S. general population, and a difference of 3 points or more is considered clinically relevant, Dr. Cote noted.
He parsed the cohort into three groups: those with RAP (508), those with chronic pancreatitis (1,086), and a reference group of healthy controls who were also in the database (1,025).
Some significant between-group differences were immediately obvious, Dr. Cote said. Patients with RAP were significantly younger than both chronic pancreatitis patients (CP) and controls (45 vs. 51 and 49 years, respectively). They also experienced their first bout of acute pancreatitis sooner than CP patients became symptomatic (40 vs. 44 years). Gender was a factor as well: CP patients were more often men (55% vs. 46%).
The pattern of alcohol use between the groups was difficult to interpret, he said. About one-quarter of RAP patients abstained, another fourth were light drinkers, and another fourth moderate drinkers – 12% drank heavily and 7% very heavily. In contrast, frequent drinking was more common among CP patients, with 12% reporting that they drank heavily and 33% very heavily.
CP patients were significantly more likely to be smokers, with 75% reporting current or past tobacco use, compared with 55% of RAP patients. More RAP patients reported never smoking (44% vs. 25%).
RAP patients fell between CP patients and controls in terms of medical comorbidities, including diabetes, renal disease or kidney failure, heart disease, and liver disease.
On the SF-12 physical component section, RAP patients scored a mean of 41 points – significantly worse than controls (51) but significantly better than CP patients (37). The findings were similar for the mental component score: RAP patients scored a mean of 45, compared with 52 in controls and 43 in CP patients.
Dr. Cote performed a multivariate analysis that controlled for age, sex, tobacco and alcohol use, and diabetes. Again, he found that, compared with controls, RAP was associated with significantly reduced scores on both the physical and mental components (mean 8.5 and 6.5 points, respectively).
“The magnitude of reduction was even greater for chronic pancreatitis, with an 11-point reduction on the physical component score and a 7.6-point reduction on the mental component score.
He then sought to identify which clinical characteristics most contributed to this impact on quality of life.
On the physical component score, several were significant, including female sex, which was associated with a 4.4-point decrease; prior pancreatic surgery (–3.3); endocrine insufficiency (–4.6); past smoking (–2.5); current smoking (–3.6); and self-reported physical disability (–9.5).
The mental component score breakdown echoed some of these. Self-reported disability exerted the largest impact, bringing the mental score down by a mean of 5.4 points. Other significant factors were smoking less than a pack a day (–2.5) and smoking more than a pack a day (–4.6). Any suspicion of chronic pancreatitis by the treating physician was associated with a 2.9-point decrease on the score.
“Our findings stress that this is not a disease that can be followed conservatively. We have to investigate interventions that will attenuate it, not only because these patients may go on to develop chronic pancreatitis but because, in their current state, most are experiencing significant reductions in their quality of life.”
Dr Cote had no financial disclosures.
[email protected]
On Twitter @alz_gal
AT DDW
Key clinical point:
Major finding: On a physical QOL scale, patients scored a mean of 41 points – 10 points lower than controls. The mental QOL score was 7 points lower.
Data source: The database review comprised 2,619 subjects.
Disclosures: Dr. Cote had no financial disclosures.
FDA approves first specific treatment for giant cell arteritis
The Food and Drug Administration has approved subcutaneous tocilizumab (Actemra) for the treatment of giant cell arteritis, according to a May 22 announcement from the agency.
Giant cell arteritis is a type of vasculitis that inflames blood vessels in the head, causing arteries to narrow or become irregular. The temporal arteries are the most commonly affected blood vessels, but giant cell arteritis can also affect other large blood vessels such as the aorta. Tocilizumab is the first drug specifically intended to treat giant cell arteritis. The standard treatment has typically been high doses of corticosteroids, tapered over time.
The FDA’s approval of tocilizumab was based on results from a double-blind, placebo-controlled study of 251 patients with giant cell arteritis. After 1 year, patients who received tocilizumab and tapered prednisone achieved remission at a higher rate than did patients who received placebo and tapered prednisone. Safety was consistent with tocilizumab’s known safety profile.
Subcutaneous tocilizumab is also approved for moderate to severely active rheumatoid arthritis. The intravenous formulation is approved for the treatment of moderate to severely active rheumatoid arthritis, systemic juvenile idiopathic arthritis, and polyarticular juvenile idiopathic arthritis.
The FDA granted both Breakthrough Therapy and Priority Review designations to this supplemental new drug application of tocilizumab.
The Food and Drug Administration has approved subcutaneous tocilizumab (Actemra) for the treatment of giant cell arteritis, according to a May 22 announcement from the agency.
Giant cell arteritis is a type of vasculitis that inflames blood vessels in the head, causing arteries to narrow or become irregular. The temporal arteries are the most commonly affected blood vessels, but giant cell arteritis can also affect other large blood vessels such as the aorta. Tocilizumab is the first drug specifically intended to treat giant cell arteritis. The standard treatment has typically been high doses of corticosteroids, tapered over time.
The FDA’s approval of tocilizumab was based on results from a double-blind, placebo-controlled study of 251 patients with giant cell arteritis. After 1 year, patients who received tocilizumab and tapered prednisone achieved remission at a higher rate than did patients who received placebo and tapered prednisone. Safety was consistent with tocilizumab’s known safety profile.
Subcutaneous tocilizumab is also approved for moderate to severely active rheumatoid arthritis. The intravenous formulation is approved for the treatment of moderate to severely active rheumatoid arthritis, systemic juvenile idiopathic arthritis, and polyarticular juvenile idiopathic arthritis.
The FDA granted both Breakthrough Therapy and Priority Review designations to this supplemental new drug application of tocilizumab.
The Food and Drug Administration has approved subcutaneous tocilizumab (Actemra) for the treatment of giant cell arteritis, according to a May 22 announcement from the agency.
Giant cell arteritis is a type of vasculitis that inflames blood vessels in the head, causing arteries to narrow or become irregular. The temporal arteries are the most commonly affected blood vessels, but giant cell arteritis can also affect other large blood vessels such as the aorta. Tocilizumab is the first drug specifically intended to treat giant cell arteritis. The standard treatment has typically been high doses of corticosteroids, tapered over time.
The FDA’s approval of tocilizumab was based on results from a double-blind, placebo-controlled study of 251 patients with giant cell arteritis. After 1 year, patients who received tocilizumab and tapered prednisone achieved remission at a higher rate than did patients who received placebo and tapered prednisone. Safety was consistent with tocilizumab’s known safety profile.
Subcutaneous tocilizumab is also approved for moderate to severely active rheumatoid arthritis. The intravenous formulation is approved for the treatment of moderate to severely active rheumatoid arthritis, systemic juvenile idiopathic arthritis, and polyarticular juvenile idiopathic arthritis.
The FDA granted both Breakthrough Therapy and Priority Review designations to this supplemental new drug application of tocilizumab.
Skin cancer risk similar for liver and kidney transplant recipients
SYDNEY – The risk of developing nonmelanoma skin cancer among liver transplant recipients is similar to that among kidney transplant recipients, but the former tend to have more skin cancer risk factors at baseline, according to a longitudinal cohort study reported at the annual meeting of the Australasian College of Dermatologists.
Liver transplant recipients have been thought to be at a lower risk of developing nonmelanoma skin cancers than are other solid organ transplant recipients, said Ludi Ge, MD, of the department of dermatology at the University of Sydney and Royal Prince Alfred Hospital, Sydney. However, data from a longitudinal cohort study of 230 kidney or liver transplant patients suggest the risk of nonmelanoma skin cancer is similar – if not greater – among liver transplant recipients, compared with kidney transplant recipients.
Over a 5-year period, 47% of liver transplant recipients developed at least one nonmelanoma skin cancer, compared with 33% of renal transplant recipients, representing a 78% greater risk among liver transplant recipients. However, Dr. Ge said the confidence intervals were wide, and the difference lost statistical significance in the multivariate analysis.
The researchers also noted that the liver transplant recipients in the study tended to be older at baseline, with a history of more sun exposure and more previous skin cancers, and were more likely to have a high risk skin type that sunburns easily.
In an interview, Dr. Ge said the findings had implications for the screening and follow-up of liver transplant recipients.
“Previously, we always thought that liver transplant recipients were at lower risk, and, possibly, they’re not screened as much so not followed up as much,” she said. “I think they really should be thought ... as high risk as renal transplant patients and the heart and lung transplant patients.”
The study showed that, while the renal transplant patients developed fewer skin cancers, they developed 1.9 lesions per year on average, compared with liver transplant patients, who developed 1.4 lesions per year.
The majority of skin cancers in both groups were squamous cell carcinomas and basal cell carcinomas, with a small number of keratoacanthomas. There was a similar ratio of squamous cell carcinomas to basal cell carcinomas between the two groups of transplant recipients – 1.7:1 in renal transplant recipients and 1.6:1 in liver recipients – which differed from the previously reported ratios of about 3:1, Dr. Ge said at the meeting.
She noted that this may have been because not every squamous cell carcinoma in situ was biopsied because of the sheer number of tumors, so many were treated empirically and, therefore, not entered into the clinic database.
Dr. Ge also pointed out that the evidence for the 3:1 ratio was around 10 years old.
“I think there’s been quite a change in the immunosuppressants that are used by transplant physicians, so, more and more, we’re seeing the use of sirolimus and everolimus, which are antiangiogenic,” she said.
Dr. Ge also strongly recommended that dermatology clinics specifically manage organ transplant recipients and commented that this could revolutionize the management of these patients, who tend to get lost to follow-up in standard dermatology clinics. “They’re very difficult to look after, they develop innumerable skin cancers that can result in death, and you need to intervene quite early,” she said in the interview.
No conflicts of interest were declared.
SYDNEY – The risk of developing nonmelanoma skin cancer among liver transplant recipients is similar to that among kidney transplant recipients, but the former tend to have more skin cancer risk factors at baseline, according to a longitudinal cohort study reported at the annual meeting of the Australasian College of Dermatologists.
Liver transplant recipients have been thought to be at a lower risk of developing nonmelanoma skin cancers than are other solid organ transplant recipients, said Ludi Ge, MD, of the department of dermatology at the University of Sydney and Royal Prince Alfred Hospital, Sydney. However, data from a longitudinal cohort study of 230 kidney or liver transplant patients suggest the risk of nonmelanoma skin cancer is similar – if not greater – among liver transplant recipients, compared with kidney transplant recipients.
Over a 5-year period, 47% of liver transplant recipients developed at least one nonmelanoma skin cancer, compared with 33% of renal transplant recipients, representing a 78% greater risk among liver transplant recipients. However, Dr. Ge said the confidence intervals were wide, and the difference lost statistical significance in the multivariate analysis.
The researchers also noted that the liver transplant recipients in the study tended to be older at baseline, with a history of more sun exposure and more previous skin cancers, and were more likely to have a high risk skin type that sunburns easily.
In an interview, Dr. Ge said the findings had implications for the screening and follow-up of liver transplant recipients.
“Previously, we always thought that liver transplant recipients were at lower risk, and, possibly, they’re not screened as much so not followed up as much,” she said. “I think they really should be thought ... as high risk as renal transplant patients and the heart and lung transplant patients.”
The study showed that, while the renal transplant patients developed fewer skin cancers, they developed 1.9 lesions per year on average, compared with liver transplant patients, who developed 1.4 lesions per year.
The majority of skin cancers in both groups were squamous cell carcinomas and basal cell carcinomas, with a small number of keratoacanthomas. There was a similar ratio of squamous cell carcinomas to basal cell carcinomas between the two groups of transplant recipients – 1.7:1 in renal transplant recipients and 1.6:1 in liver recipients – which differed from the previously reported ratios of about 3:1, Dr. Ge said at the meeting.
She noted that this may have been because not every squamous cell carcinoma in situ was biopsied because of the sheer number of tumors, so many were treated empirically and, therefore, not entered into the clinic database.
Dr. Ge also pointed out that the evidence for the 3:1 ratio was around 10 years old.
“I think there’s been quite a change in the immunosuppressants that are used by transplant physicians, so, more and more, we’re seeing the use of sirolimus and everolimus, which are antiangiogenic,” she said.
Dr. Ge also strongly recommended that dermatology clinics specifically manage organ transplant recipients and commented that this could revolutionize the management of these patients, who tend to get lost to follow-up in standard dermatology clinics. “They’re very difficult to look after, they develop innumerable skin cancers that can result in death, and you need to intervene quite early,” she said in the interview.
No conflicts of interest were declared.
SYDNEY – The risk of developing nonmelanoma skin cancer among liver transplant recipients is similar to that among kidney transplant recipients, but the former tend to have more skin cancer risk factors at baseline, according to a longitudinal cohort study reported at the annual meeting of the Australasian College of Dermatologists.
Liver transplant recipients have been thought to be at a lower risk of developing nonmelanoma skin cancers than are other solid organ transplant recipients, said Ludi Ge, MD, of the department of dermatology at the University of Sydney and Royal Prince Alfred Hospital, Sydney. However, data from a longitudinal cohort study of 230 kidney or liver transplant patients suggest the risk of nonmelanoma skin cancer is similar – if not greater – among liver transplant recipients, compared with kidney transplant recipients.
Over a 5-year period, 47% of liver transplant recipients developed at least one nonmelanoma skin cancer, compared with 33% of renal transplant recipients, representing a 78% greater risk among liver transplant recipients. However, Dr. Ge said the confidence intervals were wide, and the difference lost statistical significance in the multivariate analysis.
The researchers also noted that the liver transplant recipients in the study tended to be older at baseline, with a history of more sun exposure and more previous skin cancers, and were more likely to have a high risk skin type that sunburns easily.
In an interview, Dr. Ge said the findings had implications for the screening and follow-up of liver transplant recipients.
“Previously, we always thought that liver transplant recipients were at lower risk, and, possibly, they’re not screened as much so not followed up as much,” she said. “I think they really should be thought ... as high risk as renal transplant patients and the heart and lung transplant patients.”
The study showed that, while the renal transplant patients developed fewer skin cancers, they developed 1.9 lesions per year on average, compared with liver transplant patients, who developed 1.4 lesions per year.
The majority of skin cancers in both groups were squamous cell carcinomas and basal cell carcinomas, with a small number of keratoacanthomas. There was a similar ratio of squamous cell carcinomas to basal cell carcinomas between the two groups of transplant recipients – 1.7:1 in renal transplant recipients and 1.6:1 in liver recipients – which differed from the previously reported ratios of about 3:1, Dr. Ge said at the meeting.
She noted that this may have been because not every squamous cell carcinoma in situ was biopsied because of the sheer number of tumors, so many were treated empirically and, therefore, not entered into the clinic database.
Dr. Ge also pointed out that the evidence for the 3:1 ratio was around 10 years old.
“I think there’s been quite a change in the immunosuppressants that are used by transplant physicians, so, more and more, we’re seeing the use of sirolimus and everolimus, which are antiangiogenic,” she said.
Dr. Ge also strongly recommended that dermatology clinics specifically manage organ transplant recipients and commented that this could revolutionize the management of these patients, who tend to get lost to follow-up in standard dermatology clinics. “They’re very difficult to look after, they develop innumerable skin cancers that can result in death, and you need to intervene quite early,” she said in the interview.
No conflicts of interest were declared.
AT ACDASM 2017
Key clinical point: Liver transplant recipients should be screened and followed for the development of nonmelanoma skin cancers as closely as are kidney transplant recipients.
Major finding: Over 5 years, 47% of liver transplant recipients developed at least one nonmelanoma skin cancer, compared with 33% of renal transplant recipients, a difference that was not statistically significant after a multivariate analysis was done.
Data source: A longitudinal cohort study of 230 kidney or liver transplant recipients attending a dermatology clinic affiliated with an organ transplant unit.
Disclosures: No conflicts of interest were disclosed.
Pregnancy boosts risk of ventral hernia recurrence
Pregnancy is associated with a significant increase in the risk of ventral hernia recurrence after repair, according to a population-based cohort study published online in the American Journal of Surgery.
Analysis of registry data from 3,578 Danish women of reproductive age who had previously undergone ventral hernia repair showed that subsequent pregnancy was associated with a 56% higher risk of recurrence (95% confidence interval, 1.09-2.25; P = .016), compared with women who did not get pregnant (Am J Surg. 2017 April 5. doi: 10.1016/j.amjsurg.2017.03.044).
They noted that few studies have directly reported on the rate of ventral hernia recurrence after pregnancy, and the results that do exist are conflicting.
The overall rate of ventral hernia recurrence in the cohort was 12.5%, 67.9% of whom subsequently underwent reoperation to repair. The median time from hernia repair to pregnancy was 1.1 years, and median follow-up was 3.1 years.
Umbilical and incisional hernia repair were independently associated with a higher risk of recurrence (hazard ratio, 1.55 and 3.30, respectively) than epigastric repair, while larger hernia defects also increased the risk of recurrence.
“According to Laplace’s law, both the abdominal wall stretch and the raised intra-abdominal pressure theoretically strain the repaired ventral hernia site and are likely involved in the associated increased risk of recurrence,” the authors wrote. “Furthermore, prolonged duration of the second stage of labor and the use of manual fundal pressure might increase the risk of ventral hernia recurrence.”
The authors pointed out that inadequate fixation and lateral detachment of the mesh material were the most commonly reported mechanisms involved in ventral hernia recurrence after mesh repair. The fact that most mesh materials are far less elastic than the abdominal wall could account for the association between pregnancy and recurrence.
Based on the findings, they suggested that elective surgery for incisional or umbilical hernia repair be postponed until after the last planned pregnancy and that female patients of reproductive age be counseled on the increased risk of recurrence with pregnancy should they choose to undergo ventral hernia repair. They also noted that the natural course of an untreated ventral hernia, how it responds to pregnancy, and the risk of emergency repair during pregnancy need further investigation.
The study was supported by grants from Edgar Schnohr, MD, Dr MSc & Wife Gilberte Schnohr’s Foundation, and Bispebjerg Hospital. No conflicts of interest were declared.
Pregnancy is associated with a significant increase in the risk of ventral hernia recurrence after repair, according to a population-based cohort study published online in the American Journal of Surgery.
Analysis of registry data from 3,578 Danish women of reproductive age who had previously undergone ventral hernia repair showed that subsequent pregnancy was associated with a 56% higher risk of recurrence (95% confidence interval, 1.09-2.25; P = .016), compared with women who did not get pregnant (Am J Surg. 2017 April 5. doi: 10.1016/j.amjsurg.2017.03.044).
They noted that few studies have directly reported on the rate of ventral hernia recurrence after pregnancy, and the results that do exist are conflicting.
The overall rate of ventral hernia recurrence in the cohort was 12.5%, 67.9% of whom subsequently underwent reoperation to repair. The median time from hernia repair to pregnancy was 1.1 years, and median follow-up was 3.1 years.
Umbilical and incisional hernia repair were independently associated with a higher risk of recurrence (hazard ratio, 1.55 and 3.30, respectively) than epigastric repair, while larger hernia defects also increased the risk of recurrence.
“According to Laplace’s law, both the abdominal wall stretch and the raised intra-abdominal pressure theoretically strain the repaired ventral hernia site and are likely involved in the associated increased risk of recurrence,” the authors wrote. “Furthermore, prolonged duration of the second stage of labor and the use of manual fundal pressure might increase the risk of ventral hernia recurrence.”
The authors pointed out that inadequate fixation and lateral detachment of the mesh material were the most commonly reported mechanisms involved in ventral hernia recurrence after mesh repair. The fact that most mesh materials are far less elastic than the abdominal wall could account for the association between pregnancy and recurrence.
Based on the findings, they suggested that elective surgery for incisional or umbilical hernia repair be postponed until after the last planned pregnancy and that female patients of reproductive age be counseled on the increased risk of recurrence with pregnancy should they choose to undergo ventral hernia repair. They also noted that the natural course of an untreated ventral hernia, how it responds to pregnancy, and the risk of emergency repair during pregnancy need further investigation.
The study was supported by grants from Edgar Schnohr, MD, Dr MSc & Wife Gilberte Schnohr’s Foundation, and Bispebjerg Hospital. No conflicts of interest were declared.
Pregnancy is associated with a significant increase in the risk of ventral hernia recurrence after repair, according to a population-based cohort study published online in the American Journal of Surgery.
Analysis of registry data from 3,578 Danish women of reproductive age who had previously undergone ventral hernia repair showed that subsequent pregnancy was associated with a 56% higher risk of recurrence (95% confidence interval, 1.09-2.25; P = .016), compared with women who did not get pregnant (Am J Surg. 2017 April 5. doi: 10.1016/j.amjsurg.2017.03.044).
They noted that few studies have directly reported on the rate of ventral hernia recurrence after pregnancy, and the results that do exist are conflicting.
The overall rate of ventral hernia recurrence in the cohort was 12.5%, 67.9% of whom subsequently underwent reoperation to repair. The median time from hernia repair to pregnancy was 1.1 years, and median follow-up was 3.1 years.
Umbilical and incisional hernia repair were independently associated with a higher risk of recurrence (hazard ratio, 1.55 and 3.30, respectively) than epigastric repair, while larger hernia defects also increased the risk of recurrence.
“According to Laplace’s law, both the abdominal wall stretch and the raised intra-abdominal pressure theoretically strain the repaired ventral hernia site and are likely involved in the associated increased risk of recurrence,” the authors wrote. “Furthermore, prolonged duration of the second stage of labor and the use of manual fundal pressure might increase the risk of ventral hernia recurrence.”
The authors pointed out that inadequate fixation and lateral detachment of the mesh material were the most commonly reported mechanisms involved in ventral hernia recurrence after mesh repair. The fact that most mesh materials are far less elastic than the abdominal wall could account for the association between pregnancy and recurrence.
Based on the findings, they suggested that elective surgery for incisional or umbilical hernia repair be postponed until after the last planned pregnancy and that female patients of reproductive age be counseled on the increased risk of recurrence with pregnancy should they choose to undergo ventral hernia repair. They also noted that the natural course of an untreated ventral hernia, how it responds to pregnancy, and the risk of emergency repair during pregnancy need further investigation.
The study was supported by grants from Edgar Schnohr, MD, Dr MSc & Wife Gilberte Schnohr’s Foundation, and Bispebjerg Hospital. No conflicts of interest were declared.
FROM THE AMERICAN JOURNAL OF SURGERY
Key clinical point: Pregnancy after ventral hernia repair can significantly increase the risk of recurrence.
Major finding: Pregnancy is associated with a 56% increase in the risk of recurrence of ventral hernia after repair.
Data source: A population-based cohort study of 3,578 women of reproductive age who underwent ventral hernia repair.
Disclosures: The study was supported by grants from Edgar Schnohr MD, Dr MSc & Wife Gilberte Schnohr’s Foundation, and Bispebjerg Hospital. No conflicts of interest were declared.
Speedy sepsis care slows in-hospital mortality
WASHINGTON – Sepsis and septic shock patients treated within 3 hours had lower in-hospital mortality rates than those treated between hours 3 and 12, based on data from nearly 50,000 adult patients. The findings were presented at an international conference of the American Thoracic Society and published simultaneously in the New England Journal of Medicine.
“Considerable controversy exists about how rapidly sepsis must be treated,” wrote Christopher Seymour, MD, of the University of Pittsburgh, Pennsylvania, and his colleagues. The researchers reviewed data from New York State, where hospitals have mandated protocols for sepsis treatment, to assess the impact of treatment timing on risk-adjusted mortality (NEJM. 2017. doi: 10.1056/NEJMoa1703058).
The primary outcome was in-hospital mortality, and each hour taken to complete the 3-hour treatment bundle was associated with increased mortality (odds ratio, 1.04 per hour). Overall, patients whose 3-hour treatment bundle was completed between 3 and 12 hours after hospital admission were 14% more likely to die than those who received the treatment bundle within 3 hours.
“These associations appeared to be stronger among patients receiving vasopressors than among those who were not receiving vasopressors,” the researchers noted.
On average, patients received the complete 3-hour treatment bundle in 1.30 hours, antibiotics in 0.95 hours, and a fluid bolus in 2.56 hours.
Odds of risk-adjusted in-hospital mortality were significantly higher for those with a longer time to completion of the 3-hour bundle within 12 hours (OR, 1.04) and for those with a longer time to administration of antibiotics (OR, 1.04); however, the time to bolus of IV fluids did not significantly impact in-hospital mortality.
The study was limited as a review and not a randomized trial and by a lack of data on the appropriateness of broad-spectrum antibiotics, the researchers said. However, the data suggest that, if there is a causal relationship between treatment timing and mortality, “prompt recognition and faster treatment of sepsis and septic shock in the context of emergency care may reduce the incidence of avoidable deaths,” they said.
Lead author Dr. Seymour reported grants from the National Institutes of Health and financial relationships with Beckman Coulter and Edwards Lifesciences.
“To improve outcomes of sepsis, policymakers are increasingly using regulatory mechanisms intended to provide incentives to clinicians and hospitals to improve the quality of sepsis care,” wrote Tina B. Hershey, JD, MPH, and Jeremy M. Kahn, MD, in an accompanying editorial. The regulations implemented in New York State in 2013 “mandate that all hospitals in the state use evidence-based protocols for sepsis identification and management and that they report to the state government data on their sepsis-protocol adherence and treatment outcomes,” they said. Although the regulations in New York are fairly new, the data show an increased used of protocols and reduced mortality, they noted. “However, several crucial questions remain, concerning not only the regulations’ specific impact but also the broader question of the value of statewide mandates for protocolized sepsis care,” they said.
Ms. Hershey and Dr. Kahn are affiliated with the University of Pittsburgh, Pennsylvania, in the department of health policy and management and the department of critical care medicine, respectively. Both Ms. Hershey and Dr. Kahn disclosed that their institutions have applied for federal grants to study sepsis policymaking and its impact on health care costs and outcomes.
“To improve outcomes of sepsis, policymakers are increasingly using regulatory mechanisms intended to provide incentives to clinicians and hospitals to improve the quality of sepsis care,” wrote Tina B. Hershey, JD, MPH, and Jeremy M. Kahn, MD, in an accompanying editorial. The regulations implemented in New York State in 2013 “mandate that all hospitals in the state use evidence-based protocols for sepsis identification and management and that they report to the state government data on their sepsis-protocol adherence and treatment outcomes,” they said. Although the regulations in New York are fairly new, the data show an increased used of protocols and reduced mortality, they noted. “However, several crucial questions remain, concerning not only the regulations’ specific impact but also the broader question of the value of statewide mandates for protocolized sepsis care,” they said.
Ms. Hershey and Dr. Kahn are affiliated with the University of Pittsburgh, Pennsylvania, in the department of health policy and management and the department of critical care medicine, respectively. Both Ms. Hershey and Dr. Kahn disclosed that their institutions have applied for federal grants to study sepsis policymaking and its impact on health care costs and outcomes.
“To improve outcomes of sepsis, policymakers are increasingly using regulatory mechanisms intended to provide incentives to clinicians and hospitals to improve the quality of sepsis care,” wrote Tina B. Hershey, JD, MPH, and Jeremy M. Kahn, MD, in an accompanying editorial. The regulations implemented in New York State in 2013 “mandate that all hospitals in the state use evidence-based protocols for sepsis identification and management and that they report to the state government data on their sepsis-protocol adherence and treatment outcomes,” they said. Although the regulations in New York are fairly new, the data show an increased used of protocols and reduced mortality, they noted. “However, several crucial questions remain, concerning not only the regulations’ specific impact but also the broader question of the value of statewide mandates for protocolized sepsis care,” they said.
Ms. Hershey and Dr. Kahn are affiliated with the University of Pittsburgh, Pennsylvania, in the department of health policy and management and the department of critical care medicine, respectively. Both Ms. Hershey and Dr. Kahn disclosed that their institutions have applied for federal grants to study sepsis policymaking and its impact on health care costs and outcomes.
WASHINGTON – Sepsis and septic shock patients treated within 3 hours had lower in-hospital mortality rates than those treated between hours 3 and 12, based on data from nearly 50,000 adult patients. The findings were presented at an international conference of the American Thoracic Society and published simultaneously in the New England Journal of Medicine.
“Considerable controversy exists about how rapidly sepsis must be treated,” wrote Christopher Seymour, MD, of the University of Pittsburgh, Pennsylvania, and his colleagues. The researchers reviewed data from New York State, where hospitals have mandated protocols for sepsis treatment, to assess the impact of treatment timing on risk-adjusted mortality (NEJM. 2017. doi: 10.1056/NEJMoa1703058).
The primary outcome was in-hospital mortality, and each hour taken to complete the 3-hour treatment bundle was associated with increased mortality (odds ratio, 1.04 per hour). Overall, patients whose 3-hour treatment bundle was completed between 3 and 12 hours after hospital admission were 14% more likely to die than those who received the treatment bundle within 3 hours.
“These associations appeared to be stronger among patients receiving vasopressors than among those who were not receiving vasopressors,” the researchers noted.
On average, patients received the complete 3-hour treatment bundle in 1.30 hours, antibiotics in 0.95 hours, and a fluid bolus in 2.56 hours.
Odds of risk-adjusted in-hospital mortality were significantly higher for those with a longer time to completion of the 3-hour bundle within 12 hours (OR, 1.04) and for those with a longer time to administration of antibiotics (OR, 1.04); however, the time to bolus of IV fluids did not significantly impact in-hospital mortality.
The study was limited as a review and not a randomized trial and by a lack of data on the appropriateness of broad-spectrum antibiotics, the researchers said. However, the data suggest that, if there is a causal relationship between treatment timing and mortality, “prompt recognition and faster treatment of sepsis and septic shock in the context of emergency care may reduce the incidence of avoidable deaths,” they said.
Lead author Dr. Seymour reported grants from the National Institutes of Health and financial relationships with Beckman Coulter and Edwards Lifesciences.
WASHINGTON – Sepsis and septic shock patients treated within 3 hours had lower in-hospital mortality rates than those treated between hours 3 and 12, based on data from nearly 50,000 adult patients. The findings were presented at an international conference of the American Thoracic Society and published simultaneously in the New England Journal of Medicine.
“Considerable controversy exists about how rapidly sepsis must be treated,” wrote Christopher Seymour, MD, of the University of Pittsburgh, Pennsylvania, and his colleagues. The researchers reviewed data from New York State, where hospitals have mandated protocols for sepsis treatment, to assess the impact of treatment timing on risk-adjusted mortality (NEJM. 2017. doi: 10.1056/NEJMoa1703058).
The primary outcome was in-hospital mortality, and each hour taken to complete the 3-hour treatment bundle was associated with increased mortality (odds ratio, 1.04 per hour). Overall, patients whose 3-hour treatment bundle was completed between 3 and 12 hours after hospital admission were 14% more likely to die than those who received the treatment bundle within 3 hours.
“These associations appeared to be stronger among patients receiving vasopressors than among those who were not receiving vasopressors,” the researchers noted.
On average, patients received the complete 3-hour treatment bundle in 1.30 hours, antibiotics in 0.95 hours, and a fluid bolus in 2.56 hours.
Odds of risk-adjusted in-hospital mortality were significantly higher for those with a longer time to completion of the 3-hour bundle within 12 hours (OR, 1.04) and for those with a longer time to administration of antibiotics (OR, 1.04); however, the time to bolus of IV fluids did not significantly impact in-hospital mortality.
The study was limited as a review and not a randomized trial and by a lack of data on the appropriateness of broad-spectrum antibiotics, the researchers said. However, the data suggest that, if there is a causal relationship between treatment timing and mortality, “prompt recognition and faster treatment of sepsis and septic shock in the context of emergency care may reduce the incidence of avoidable deaths,” they said.
Lead author Dr. Seymour reported grants from the National Institutes of Health and financial relationships with Beckman Coulter and Edwards Lifesciences.
Key clinical point: In-hospital mortality rates were lower for sepsis patients who were treated more rapidly (within 3 hours) with a 3-hour bundle of sepsis care and antibiotics.
Major finding: Sepsis patients whose 3-hour treatment bundle was completed between hour 3 and 12 were 14% more likely to die than those who received the treatment within 3 hours.
Data source: A review of data from 49,331 sepsis and septic shock patients at 149 hospitals.
Disclosures: Lead author Dr. Seymour reported grants from the National Institutes of Health and financial relationships with Beckman Coulter and Edwards Lifesciences.
IL-2 and IL-8 elevated after gluten ingestion on gluten-free diet
CHICAGO – A gluten-free diet is often implemented by patients before they are evaluated for celiac disease, which, in turn, does not allow for accurate celiac disease testing.
A new study shows, however, that measuring serum cytokines following a gluten challenge may allow an accurate diagnosis of celiac disease to be made, even after patients have been on a gluten-free diet.
Levels of IL-2 and IL-8 were increased 2-4 hours after ingestion of gluten. Elevations in other cytokines occurred less frequently, and changes in cytokine levels were similar in both serum and plasma.
“IL-2 is a cytokine produced exclusively by T cells and goes up from 2 hours after gluten consumption in celiac patients and is highly specific,” said study author Robert P. Anderson, MD, of Immusant, Cambridge, Mass., who presented the findings of his study at Digestive Disease Week®. “Rises in IL 8 are less but significant as well.”
The authors note that individuals who are already on a gluten-free diet and who would like a definitive diagnosis of celiac disease all too often refuse or are unable to tolerate a gluten challenge for the time period that is needed – usually 4 or more weeks – for the serologic and histologic markers of celiac disease to become abnormal.
Dr. Anderson pointed out that elevated plasma levels of IL-2 and IL-8 accompanied by gastrointestinal symptoms have been observed 4 hours after receiving a single dose of Nexvax2, a therapeutic vaccine being developed by Immusant. The peptide-based vaccine is intended to protect against the effects of gluten exposure while maintaining a gluten-free diet in HLA-DQ2.5+ patients with celiac disease.
In this study, Dr. Anderson and his colleagues hypothesized that patients with celiac disease who were on a gluten-free diet would also exhibit elevated serum IL-2 and IL-8 after an oral gluten versus placebo challenge.
The cohort was comprised of 21 adults with HLA-DQ2.5+ celiac disease who were compliant with a gluten-free diet and who were randomized to consume either vital wheat gluten flour (5 g; ~ 3 g gluten) or a matched gluten-free flour drink (placebo) over 10 minutes.
Blood was collected prior to the challenge and then at 4, 6, and 24 hours afterwards. In addition, patient vital signs and reported outcomes were recorded hourly, and adverse events were tracked from day 1 to day 6.
At 4 hours after ingesting gluten, serum IL-2 and IL-8 were both significantly higher, compared with placebo.
“There was a 20-fold increase in IL-2 after gluten was consumed, between 3 and 5 hours afterwards,” said Dr. Anderson. “IL-8 went up but not as much.”
The median change from baseline for IL-2 after gluten intake was 19.5 ([7.0-47.1], vs. 0.7 [0.5-1.2] for placebo; P = .0001). For IL-8 it was 2.4 (1.2-4.9) vs. 1.1 (0.8-1.2) (P = .012).
Patient-reported outcomes were worse among those in the gluten group (7/12), compared with the placebo group (3/9), after 3 hours but did not reach statistical significance.
He added that his team is in the process of conducting a further study to assess the diagnostic utility of measuring cytokine activity.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
CHICAGO – A gluten-free diet is often implemented by patients before they are evaluated for celiac disease, which, in turn, does not allow for accurate celiac disease testing.
A new study shows, however, that measuring serum cytokines following a gluten challenge may allow an accurate diagnosis of celiac disease to be made, even after patients have been on a gluten-free diet.
Levels of IL-2 and IL-8 were increased 2-4 hours after ingestion of gluten. Elevations in other cytokines occurred less frequently, and changes in cytokine levels were similar in both serum and plasma.
“IL-2 is a cytokine produced exclusively by T cells and goes up from 2 hours after gluten consumption in celiac patients and is highly specific,” said study author Robert P. Anderson, MD, of Immusant, Cambridge, Mass., who presented the findings of his study at Digestive Disease Week®. “Rises in IL 8 are less but significant as well.”
The authors note that individuals who are already on a gluten-free diet and who would like a definitive diagnosis of celiac disease all too often refuse or are unable to tolerate a gluten challenge for the time period that is needed – usually 4 or more weeks – for the serologic and histologic markers of celiac disease to become abnormal.
Dr. Anderson pointed out that elevated plasma levels of IL-2 and IL-8 accompanied by gastrointestinal symptoms have been observed 4 hours after receiving a single dose of Nexvax2, a therapeutic vaccine being developed by Immusant. The peptide-based vaccine is intended to protect against the effects of gluten exposure while maintaining a gluten-free diet in HLA-DQ2.5+ patients with celiac disease.
In this study, Dr. Anderson and his colleagues hypothesized that patients with celiac disease who were on a gluten-free diet would also exhibit elevated serum IL-2 and IL-8 after an oral gluten versus placebo challenge.
The cohort was comprised of 21 adults with HLA-DQ2.5+ celiac disease who were compliant with a gluten-free diet and who were randomized to consume either vital wheat gluten flour (5 g; ~ 3 g gluten) or a matched gluten-free flour drink (placebo) over 10 minutes.
Blood was collected prior to the challenge and then at 4, 6, and 24 hours afterwards. In addition, patient vital signs and reported outcomes were recorded hourly, and adverse events were tracked from day 1 to day 6.
At 4 hours after ingesting gluten, serum IL-2 and IL-8 were both significantly higher, compared with placebo.
“There was a 20-fold increase in IL-2 after gluten was consumed, between 3 and 5 hours afterwards,” said Dr. Anderson. “IL-8 went up but not as much.”
The median change from baseline for IL-2 after gluten intake was 19.5 ([7.0-47.1], vs. 0.7 [0.5-1.2] for placebo; P = .0001). For IL-8 it was 2.4 (1.2-4.9) vs. 1.1 (0.8-1.2) (P = .012).
Patient-reported outcomes were worse among those in the gluten group (7/12), compared with the placebo group (3/9), after 3 hours but did not reach statistical significance.
He added that his team is in the process of conducting a further study to assess the diagnostic utility of measuring cytokine activity.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
CHICAGO – A gluten-free diet is often implemented by patients before they are evaluated for celiac disease, which, in turn, does not allow for accurate celiac disease testing.
A new study shows, however, that measuring serum cytokines following a gluten challenge may allow an accurate diagnosis of celiac disease to be made, even after patients have been on a gluten-free diet.
Levels of IL-2 and IL-8 were increased 2-4 hours after ingestion of gluten. Elevations in other cytokines occurred less frequently, and changes in cytokine levels were similar in both serum and plasma.
“IL-2 is a cytokine produced exclusively by T cells and goes up from 2 hours after gluten consumption in celiac patients and is highly specific,” said study author Robert P. Anderson, MD, of Immusant, Cambridge, Mass., who presented the findings of his study at Digestive Disease Week®. “Rises in IL 8 are less but significant as well.”
The authors note that individuals who are already on a gluten-free diet and who would like a definitive diagnosis of celiac disease all too often refuse or are unable to tolerate a gluten challenge for the time period that is needed – usually 4 or more weeks – for the serologic and histologic markers of celiac disease to become abnormal.
Dr. Anderson pointed out that elevated plasma levels of IL-2 and IL-8 accompanied by gastrointestinal symptoms have been observed 4 hours after receiving a single dose of Nexvax2, a therapeutic vaccine being developed by Immusant. The peptide-based vaccine is intended to protect against the effects of gluten exposure while maintaining a gluten-free diet in HLA-DQ2.5+ patients with celiac disease.
In this study, Dr. Anderson and his colleagues hypothesized that patients with celiac disease who were on a gluten-free diet would also exhibit elevated serum IL-2 and IL-8 after an oral gluten versus placebo challenge.
The cohort was comprised of 21 adults with HLA-DQ2.5+ celiac disease who were compliant with a gluten-free diet and who were randomized to consume either vital wheat gluten flour (5 g; ~ 3 g gluten) or a matched gluten-free flour drink (placebo) over 10 minutes.
Blood was collected prior to the challenge and then at 4, 6, and 24 hours afterwards. In addition, patient vital signs and reported outcomes were recorded hourly, and adverse events were tracked from day 1 to day 6.
At 4 hours after ingesting gluten, serum IL-2 and IL-8 were both significantly higher, compared with placebo.
“There was a 20-fold increase in IL-2 after gluten was consumed, between 3 and 5 hours afterwards,” said Dr. Anderson. “IL-8 went up but not as much.”
The median change from baseline for IL-2 after gluten intake was 19.5 ([7.0-47.1], vs. 0.7 [0.5-1.2] for placebo; P = .0001). For IL-8 it was 2.4 (1.2-4.9) vs. 1.1 (0.8-1.2) (P = .012).
Patient-reported outcomes were worse among those in the gluten group (7/12), compared with the placebo group (3/9), after 3 hours but did not reach statistical significance.
He added that his team is in the process of conducting a further study to assess the diagnostic utility of measuring cytokine activity.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
AT DDW
Key clinical point: Measuring serum cytokines can potentially be used to diagnose celiac disease after the patient has been on a gluten-free diet.
Major finding: There was a median 19.5-fold change from baseline for IL-2 after gluten intake (7.0-fold to 47.1-fold) and 24-fold for IL-8 (1.2-fold to 4.9-fold).
Data source: Randomized trial comprising 21 volunteers with celiac disease.
Disclosures: Dr. Anderson is employed by Immusant.