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Experts sound alarm on ruling threatening preventive cancer care
In a statement, the groups highlighted that the decision “would result in a return to financial and other barriers proven to discourage Americans from obtaining lifesaving, preventive care.”
The ruling, issued earlier in September by a federal district judge in Texas, essentially says that the U.S. Preventive Services Task Force has no authority to determine which preventive care services must be fully covered by insurance companies – an ability granted by the Affordable Care Act (ACA).
Judge Reed O’Connor ruled that the method of appointing officers to the USPSTF is unconstitutional, which means the task force’s recommendations for no-cost preventive health care may no longer be guaranteed under the ACA for millions of insured Americans.
The judgment, however, is not yet final, and individuals still have access to these preventive services. The judge must first make the scope of the ruling clear, and the decision will likely be appealed. In addition, the decision does not affect the authority of two other entities that make recommendations about vaccinations and preventive care for infants, children, and adolescents.
But experts are concerned that the ruling will force some individuals to pay out of pocket for preventive cancer screenings and other care that would otherwise have been fully covered by insurance.
After the ruling, a group of 26 patient groups, including the American Cancer Society Cancer Action Network and the Leukemia and Lymphoma Society, took a stand.
In a statement, the groups highlighted that “access to preventive health care can prevent both disease and early death.” Under the ACA, more than 150 million Americans have benefited from expanded access to these services, and research reveals that high-quality coverage – which includes preventive services – improves health, reduces health disparities, and lowers health care costs. “This ruling directly threatens these benefits,” they explained.
Lisa Lacasse, MBA, president of ACS CAN, agreed that the ruling “threatens to erode more than a decade of progress reducing cancer deaths and suffering.”
In a statement, the ACS CAN urged the government to “swiftly appeal” the decision.
“We cannot risk returning to a system wherein every individual has to interpret their complex insurance plans to determine if a recommended mammogram will be covered or to determine how much their colonoscopy may cost,” Ms. Lacasse told this news organization.
For now, Ms. Lacasse urged patients and providers to remember that no changes to coverage requirements will occur while litigation continues.
“All preventive services required under the Affordable Care Act remain in place with no cost sharing for enrollees,” she said. “ACS CAN will continue to support and advocate for coverage of preventive services at no cost sharing.”
A version of this article first appeared on Medscape.com.
In a statement, the groups highlighted that the decision “would result in a return to financial and other barriers proven to discourage Americans from obtaining lifesaving, preventive care.”
The ruling, issued earlier in September by a federal district judge in Texas, essentially says that the U.S. Preventive Services Task Force has no authority to determine which preventive care services must be fully covered by insurance companies – an ability granted by the Affordable Care Act (ACA).
Judge Reed O’Connor ruled that the method of appointing officers to the USPSTF is unconstitutional, which means the task force’s recommendations for no-cost preventive health care may no longer be guaranteed under the ACA for millions of insured Americans.
The judgment, however, is not yet final, and individuals still have access to these preventive services. The judge must first make the scope of the ruling clear, and the decision will likely be appealed. In addition, the decision does not affect the authority of two other entities that make recommendations about vaccinations and preventive care for infants, children, and adolescents.
But experts are concerned that the ruling will force some individuals to pay out of pocket for preventive cancer screenings and other care that would otherwise have been fully covered by insurance.
After the ruling, a group of 26 patient groups, including the American Cancer Society Cancer Action Network and the Leukemia and Lymphoma Society, took a stand.
In a statement, the groups highlighted that “access to preventive health care can prevent both disease and early death.” Under the ACA, more than 150 million Americans have benefited from expanded access to these services, and research reveals that high-quality coverage – which includes preventive services – improves health, reduces health disparities, and lowers health care costs. “This ruling directly threatens these benefits,” they explained.
Lisa Lacasse, MBA, president of ACS CAN, agreed that the ruling “threatens to erode more than a decade of progress reducing cancer deaths and suffering.”
In a statement, the ACS CAN urged the government to “swiftly appeal” the decision.
“We cannot risk returning to a system wherein every individual has to interpret their complex insurance plans to determine if a recommended mammogram will be covered or to determine how much their colonoscopy may cost,” Ms. Lacasse told this news organization.
For now, Ms. Lacasse urged patients and providers to remember that no changes to coverage requirements will occur while litigation continues.
“All preventive services required under the Affordable Care Act remain in place with no cost sharing for enrollees,” she said. “ACS CAN will continue to support and advocate for coverage of preventive services at no cost sharing.”
A version of this article first appeared on Medscape.com.
In a statement, the groups highlighted that the decision “would result in a return to financial and other barriers proven to discourage Americans from obtaining lifesaving, preventive care.”
The ruling, issued earlier in September by a federal district judge in Texas, essentially says that the U.S. Preventive Services Task Force has no authority to determine which preventive care services must be fully covered by insurance companies – an ability granted by the Affordable Care Act (ACA).
Judge Reed O’Connor ruled that the method of appointing officers to the USPSTF is unconstitutional, which means the task force’s recommendations for no-cost preventive health care may no longer be guaranteed under the ACA for millions of insured Americans.
The judgment, however, is not yet final, and individuals still have access to these preventive services. The judge must first make the scope of the ruling clear, and the decision will likely be appealed. In addition, the decision does not affect the authority of two other entities that make recommendations about vaccinations and preventive care for infants, children, and adolescents.
But experts are concerned that the ruling will force some individuals to pay out of pocket for preventive cancer screenings and other care that would otherwise have been fully covered by insurance.
After the ruling, a group of 26 patient groups, including the American Cancer Society Cancer Action Network and the Leukemia and Lymphoma Society, took a stand.
In a statement, the groups highlighted that “access to preventive health care can prevent both disease and early death.” Under the ACA, more than 150 million Americans have benefited from expanded access to these services, and research reveals that high-quality coverage – which includes preventive services – improves health, reduces health disparities, and lowers health care costs. “This ruling directly threatens these benefits,” they explained.
Lisa Lacasse, MBA, president of ACS CAN, agreed that the ruling “threatens to erode more than a decade of progress reducing cancer deaths and suffering.”
In a statement, the ACS CAN urged the government to “swiftly appeal” the decision.
“We cannot risk returning to a system wherein every individual has to interpret their complex insurance plans to determine if a recommended mammogram will be covered or to determine how much their colonoscopy may cost,” Ms. Lacasse told this news organization.
For now, Ms. Lacasse urged patients and providers to remember that no changes to coverage requirements will occur while litigation continues.
“All preventive services required under the Affordable Care Act remain in place with no cost sharing for enrollees,” she said. “ACS CAN will continue to support and advocate for coverage of preventive services at no cost sharing.”
A version of this article first appeared on Medscape.com.
Experts express caution over type 2 diabetes/tea-drinking claim
type 2 diabetes/tea-drinking claim
A claim that drinking tea might protect people against developing type 2 diabetes has been met with caution from multiple experts ahead of the annual meeting of the European Association for the Study of Diabetes.
The claim is that people who drink four or more cups of tea every day – specifically green, Oolong, or black tea – are 17% less likely to develop type 2 diabetes than those who do not drink tea. Drinking fewer cups of tea per day was not found to confer any benefit.
“Our results are exciting because they suggest that people can do something as simple as drinking four cups of tea a day to potentially lessen their risk of developing type 2 diabetes,” Xiaying Li of Wuhan (China) University of Science and Technology is quoted as saying in an official EASD press release.
“It is possible that particular components in tea, such as polyphenols, may reduce blood glucose levels, but a sufficient amount of these bioactive compounds may be needed to be effective,” Dr. Li added.
“The words ‘suggest’ and ‘potentially’ are crucial here,” said Kevin McConway, PhD, MSc, MBA, emeritus professor of applied statistics at The Open University, said in a separate statement to the press that reeled in Dr. Li’s enthusiasm.
“Tea drinking would only be useful for reducing diabetes risk if the tea drinking causes reductions in risk, that is, if the risk is reduced if you drink the tea and not if you don’t – and this study simply can’t show whether it does this or not,” Dr. Conway stressed.
Naveed Sattar, FMedSci FRCPath FRCPGlas FRSE, professor of metabolic medicine at the University of Glasgow, was also cautiously critical. “There is no good trial evidence whatsoever that the chemicals in tea prevent diabetes,” he observed separately.
“So, I suspect its more about tea being healthier (less calorific) than many alternative drinks or tea drinkers leading healthier lives more generally.”
Dr. Sattar added that it could be that people who drink tea might also be avoiding drinking more harmful sugary drinks and have other health behaviors that might lead them to have a lower risk for type 2 diabetes.
Time for tea?
Dr. Li will present the findings of two analyses on Sept. 21 at the EASD meeting: the first a large observational cohort study and the second an updated systematic review and meta-analysis.
For the cohort study, Dr. Li and her coauthors took data on more than 5,100 adults who had participated in the long-running and ongoing China Health and Nutrition Survey (CHNS). Information on tea drinking behavior was extracted from questionnaires that had been filled out at two time points – 1997 and 2009 – and they determined whether people had developed type 2 diabetes according to American Diabetes Association criteria.
Nearly half, 45.8%, were found to be tea drinkers, and 10% of the population they sampled had developed type 2 diabetes. No association between tea drinking and type 2 diabetes development was found, however, with the hazard ratio comparing tea drinkers and non–tea drinkers sitting firmly at 1.02. Moreover, a sensitivity analysis that excluded participants who had developed type 2 diabetes in the first 3 years of follow-up did not change the result.
Things were slightly different when Dr. Li and associates performed their meta-analysis that involved analyzing data on more than 1 million participants in 19 studies conducted in eight countries that had been published up to September 2021.
Here, they found there was a significant (P < .003) linear association between tea consumption and having type 2 diabetes, with the relative risk of developing type 2 diabetes decreasing by 0.986 for every additional cup of tea that was drunk.
HRs for the development of type 2 diabetes in tea drinkers versus non–tea drinkers were 1.00 for those who drank less than one cup per day, 0.96 for those who had one to two cups, and 0.84 for those who drank four or more cups.
“While more research needs to be done to determine the exact dosage and mechanisms behind these observations, our findings suggest that drinking tea is beneficial in reducing the risk of type 2 diabetes, but only at high doses (at least 4 cups a day)”, said Dr. Li.
Perhaps, “we did not find an association between tea drinking and type 2 diabetes in our cohort study because we did not look at higher tea consumption,” she added.
Tempest in a teacup
“This is large, observational data. It’s not a randomized controlled trial so there’s plenty of room for data to be misunderstood,” warned Matt Sydes, MSc, professor of clinical trials & methodology at the MRC Clinical Trials Unit, University College London.
“Everyone drinks fluids. If there is an effect here (and that’s a big if), it might be not about the tea they drink, but about what they don’t drink. One can’t tell at the moment. It seems unlikely that a large randomized controlled trial could be done to disambiguate” added Dr. Sydes
“Being only a conference abstract, it is difficult to assess the quality of this research,” Baptiste Leurent, PhD, a medical statistician also working at University College London, said. Not only was the cohort study observational, so were all the other studies included in the meta-analysis, he pointed out.
“Therefore, no cause-effect conclusions can be drawn. The association could simply be due to other factors, such as those drinking more tea having a healthier lifestyle. It does not seem that the authors tried to control for confounders, which is usually difficult in meta-analysis,” Dr. Leurent said.
“There is reason to be a bit skeptical at this point; we really need to have the full details to assess it properly,” said Jonathan Cook of the Centre for Statistics in Medicine at the University of Oxford (England). “It’s a fair attempt to look at this, but not cutting edge, [using] fairly standard approaches.”
Similar studies have shown a reduced risk associated with coffee drinking, noted Duane Mellor, PhD, a registered dietitian and senior teaching fellow at Aston University in Birmingham.
“The important take-home message is that lifestyle is important in managing risk of developing type 2 diabetes,” Dr. Mellor said.
“That includes choosing low-calorie drinks including mainly water as well as unsweetened tea and coffee as your drinks of choice as part of a healthy lifestyle.”
The study was funded by the Young Talents Project of Hubei Provincial Health Commission, the Science and Technology Research Key Project of Education Department of Hubei Province, the Sanuo Diabetes Charity Foundation, and the Xiangyang Science and Technology Plan Project, all based in China. Dr. Li had no conflicts of interest to disclose. Dr. McConway is a Trustee and on the advisory committee of The Science Media Centre. Dr. Sattar has consulted for many companies that make diabetes and cardiovascular drugs and has been involved in multiple trials of lifestyle approaches for the prevention and remission of diabetes. Dr. Sydes, Dr. Leurent, Dr. Cook, and Dr. Mellor had no conflicts of interest to report.
A claim that drinking tea might protect people against developing type 2 diabetes has been met with caution from multiple experts ahead of the annual meeting of the European Association for the Study of Diabetes.
The claim is that people who drink four or more cups of tea every day – specifically green, Oolong, or black tea – are 17% less likely to develop type 2 diabetes than those who do not drink tea. Drinking fewer cups of tea per day was not found to confer any benefit.
“Our results are exciting because they suggest that people can do something as simple as drinking four cups of tea a day to potentially lessen their risk of developing type 2 diabetes,” Xiaying Li of Wuhan (China) University of Science and Technology is quoted as saying in an official EASD press release.
“It is possible that particular components in tea, such as polyphenols, may reduce blood glucose levels, but a sufficient amount of these bioactive compounds may be needed to be effective,” Dr. Li added.
“The words ‘suggest’ and ‘potentially’ are crucial here,” said Kevin McConway, PhD, MSc, MBA, emeritus professor of applied statistics at The Open University, said in a separate statement to the press that reeled in Dr. Li’s enthusiasm.
“Tea drinking would only be useful for reducing diabetes risk if the tea drinking causes reductions in risk, that is, if the risk is reduced if you drink the tea and not if you don’t – and this study simply can’t show whether it does this or not,” Dr. Conway stressed.
Naveed Sattar, FMedSci FRCPath FRCPGlas FRSE, professor of metabolic medicine at the University of Glasgow, was also cautiously critical. “There is no good trial evidence whatsoever that the chemicals in tea prevent diabetes,” he observed separately.
“So, I suspect its more about tea being healthier (less calorific) than many alternative drinks or tea drinkers leading healthier lives more generally.”
Dr. Sattar added that it could be that people who drink tea might also be avoiding drinking more harmful sugary drinks and have other health behaviors that might lead them to have a lower risk for type 2 diabetes.
Time for tea?
Dr. Li will present the findings of two analyses on Sept. 21 at the EASD meeting: the first a large observational cohort study and the second an updated systematic review and meta-analysis.
For the cohort study, Dr. Li and her coauthors took data on more than 5,100 adults who had participated in the long-running and ongoing China Health and Nutrition Survey (CHNS). Information on tea drinking behavior was extracted from questionnaires that had been filled out at two time points – 1997 and 2009 – and they determined whether people had developed type 2 diabetes according to American Diabetes Association criteria.
Nearly half, 45.8%, were found to be tea drinkers, and 10% of the population they sampled had developed type 2 diabetes. No association between tea drinking and type 2 diabetes development was found, however, with the hazard ratio comparing tea drinkers and non–tea drinkers sitting firmly at 1.02. Moreover, a sensitivity analysis that excluded participants who had developed type 2 diabetes in the first 3 years of follow-up did not change the result.
Things were slightly different when Dr. Li and associates performed their meta-analysis that involved analyzing data on more than 1 million participants in 19 studies conducted in eight countries that had been published up to September 2021.
Here, they found there was a significant (P < .003) linear association between tea consumption and having type 2 diabetes, with the relative risk of developing type 2 diabetes decreasing by 0.986 for every additional cup of tea that was drunk.
HRs for the development of type 2 diabetes in tea drinkers versus non–tea drinkers were 1.00 for those who drank less than one cup per day, 0.96 for those who had one to two cups, and 0.84 for those who drank four or more cups.
“While more research needs to be done to determine the exact dosage and mechanisms behind these observations, our findings suggest that drinking tea is beneficial in reducing the risk of type 2 diabetes, but only at high doses (at least 4 cups a day)”, said Dr. Li.
Perhaps, “we did not find an association between tea drinking and type 2 diabetes in our cohort study because we did not look at higher tea consumption,” she added.
Tempest in a teacup
“This is large, observational data. It’s not a randomized controlled trial so there’s plenty of room for data to be misunderstood,” warned Matt Sydes, MSc, professor of clinical trials & methodology at the MRC Clinical Trials Unit, University College London.
“Everyone drinks fluids. If there is an effect here (and that’s a big if), it might be not about the tea they drink, but about what they don’t drink. One can’t tell at the moment. It seems unlikely that a large randomized controlled trial could be done to disambiguate” added Dr. Sydes
“Being only a conference abstract, it is difficult to assess the quality of this research,” Baptiste Leurent, PhD, a medical statistician also working at University College London, said. Not only was the cohort study observational, so were all the other studies included in the meta-analysis, he pointed out.
“Therefore, no cause-effect conclusions can be drawn. The association could simply be due to other factors, such as those drinking more tea having a healthier lifestyle. It does not seem that the authors tried to control for confounders, which is usually difficult in meta-analysis,” Dr. Leurent said.
“There is reason to be a bit skeptical at this point; we really need to have the full details to assess it properly,” said Jonathan Cook of the Centre for Statistics in Medicine at the University of Oxford (England). “It’s a fair attempt to look at this, but not cutting edge, [using] fairly standard approaches.”
Similar studies have shown a reduced risk associated with coffee drinking, noted Duane Mellor, PhD, a registered dietitian and senior teaching fellow at Aston University in Birmingham.
“The important take-home message is that lifestyle is important in managing risk of developing type 2 diabetes,” Dr. Mellor said.
“That includes choosing low-calorie drinks including mainly water as well as unsweetened tea and coffee as your drinks of choice as part of a healthy lifestyle.”
The study was funded by the Young Talents Project of Hubei Provincial Health Commission, the Science and Technology Research Key Project of Education Department of Hubei Province, the Sanuo Diabetes Charity Foundation, and the Xiangyang Science and Technology Plan Project, all based in China. Dr. Li had no conflicts of interest to disclose. Dr. McConway is a Trustee and on the advisory committee of The Science Media Centre. Dr. Sattar has consulted for many companies that make diabetes and cardiovascular drugs and has been involved in multiple trials of lifestyle approaches for the prevention and remission of diabetes. Dr. Sydes, Dr. Leurent, Dr. Cook, and Dr. Mellor had no conflicts of interest to report.
A claim that drinking tea might protect people against developing type 2 diabetes has been met with caution from multiple experts ahead of the annual meeting of the European Association for the Study of Diabetes.
The claim is that people who drink four or more cups of tea every day – specifically green, Oolong, or black tea – are 17% less likely to develop type 2 diabetes than those who do not drink tea. Drinking fewer cups of tea per day was not found to confer any benefit.
“Our results are exciting because they suggest that people can do something as simple as drinking four cups of tea a day to potentially lessen their risk of developing type 2 diabetes,” Xiaying Li of Wuhan (China) University of Science and Technology is quoted as saying in an official EASD press release.
“It is possible that particular components in tea, such as polyphenols, may reduce blood glucose levels, but a sufficient amount of these bioactive compounds may be needed to be effective,” Dr. Li added.
“The words ‘suggest’ and ‘potentially’ are crucial here,” said Kevin McConway, PhD, MSc, MBA, emeritus professor of applied statistics at The Open University, said in a separate statement to the press that reeled in Dr. Li’s enthusiasm.
“Tea drinking would only be useful for reducing diabetes risk if the tea drinking causes reductions in risk, that is, if the risk is reduced if you drink the tea and not if you don’t – and this study simply can’t show whether it does this or not,” Dr. Conway stressed.
Naveed Sattar, FMedSci FRCPath FRCPGlas FRSE, professor of metabolic medicine at the University of Glasgow, was also cautiously critical. “There is no good trial evidence whatsoever that the chemicals in tea prevent diabetes,” he observed separately.
“So, I suspect its more about tea being healthier (less calorific) than many alternative drinks or tea drinkers leading healthier lives more generally.”
Dr. Sattar added that it could be that people who drink tea might also be avoiding drinking more harmful sugary drinks and have other health behaviors that might lead them to have a lower risk for type 2 diabetes.
Time for tea?
Dr. Li will present the findings of two analyses on Sept. 21 at the EASD meeting: the first a large observational cohort study and the second an updated systematic review and meta-analysis.
For the cohort study, Dr. Li and her coauthors took data on more than 5,100 adults who had participated in the long-running and ongoing China Health and Nutrition Survey (CHNS). Information on tea drinking behavior was extracted from questionnaires that had been filled out at two time points – 1997 and 2009 – and they determined whether people had developed type 2 diabetes according to American Diabetes Association criteria.
Nearly half, 45.8%, were found to be tea drinkers, and 10% of the population they sampled had developed type 2 diabetes. No association between tea drinking and type 2 diabetes development was found, however, with the hazard ratio comparing tea drinkers and non–tea drinkers sitting firmly at 1.02. Moreover, a sensitivity analysis that excluded participants who had developed type 2 diabetes in the first 3 years of follow-up did not change the result.
Things were slightly different when Dr. Li and associates performed their meta-analysis that involved analyzing data on more than 1 million participants in 19 studies conducted in eight countries that had been published up to September 2021.
Here, they found there was a significant (P < .003) linear association between tea consumption and having type 2 diabetes, with the relative risk of developing type 2 diabetes decreasing by 0.986 for every additional cup of tea that was drunk.
HRs for the development of type 2 diabetes in tea drinkers versus non–tea drinkers were 1.00 for those who drank less than one cup per day, 0.96 for those who had one to two cups, and 0.84 for those who drank four or more cups.
“While more research needs to be done to determine the exact dosage and mechanisms behind these observations, our findings suggest that drinking tea is beneficial in reducing the risk of type 2 diabetes, but only at high doses (at least 4 cups a day)”, said Dr. Li.
Perhaps, “we did not find an association between tea drinking and type 2 diabetes in our cohort study because we did not look at higher tea consumption,” she added.
Tempest in a teacup
“This is large, observational data. It’s not a randomized controlled trial so there’s plenty of room for data to be misunderstood,” warned Matt Sydes, MSc, professor of clinical trials & methodology at the MRC Clinical Trials Unit, University College London.
“Everyone drinks fluids. If there is an effect here (and that’s a big if), it might be not about the tea they drink, but about what they don’t drink. One can’t tell at the moment. It seems unlikely that a large randomized controlled trial could be done to disambiguate” added Dr. Sydes
“Being only a conference abstract, it is difficult to assess the quality of this research,” Baptiste Leurent, PhD, a medical statistician also working at University College London, said. Not only was the cohort study observational, so were all the other studies included in the meta-analysis, he pointed out.
“Therefore, no cause-effect conclusions can be drawn. The association could simply be due to other factors, such as those drinking more tea having a healthier lifestyle. It does not seem that the authors tried to control for confounders, which is usually difficult in meta-analysis,” Dr. Leurent said.
“There is reason to be a bit skeptical at this point; we really need to have the full details to assess it properly,” said Jonathan Cook of the Centre for Statistics in Medicine at the University of Oxford (England). “It’s a fair attempt to look at this, but not cutting edge, [using] fairly standard approaches.”
Similar studies have shown a reduced risk associated with coffee drinking, noted Duane Mellor, PhD, a registered dietitian and senior teaching fellow at Aston University in Birmingham.
“The important take-home message is that lifestyle is important in managing risk of developing type 2 diabetes,” Dr. Mellor said.
“That includes choosing low-calorie drinks including mainly water as well as unsweetened tea and coffee as your drinks of choice as part of a healthy lifestyle.”
The study was funded by the Young Talents Project of Hubei Provincial Health Commission, the Science and Technology Research Key Project of Education Department of Hubei Province, the Sanuo Diabetes Charity Foundation, and the Xiangyang Science and Technology Plan Project, all based in China. Dr. Li had no conflicts of interest to disclose. Dr. McConway is a Trustee and on the advisory committee of The Science Media Centre. Dr. Sattar has consulted for many companies that make diabetes and cardiovascular drugs and has been involved in multiple trials of lifestyle approaches for the prevention and remission of diabetes. Dr. Sydes, Dr. Leurent, Dr. Cook, and Dr. Mellor had no conflicts of interest to report.
type 2 diabetes/tea-drinking claim
type 2 diabetes/tea-drinking claim
FROM EASD 2022
At EASD, docs to eye new tactics for type 2 diabetes
Highlights of the European Association for the Study of Diabetes 2022 annual meeting include new data on weight loss with the blockbuster twincretin tirzepatide and on the effects of dapagliflozin on heart failure in people with diabetes, as well as updated guidelines for type 2 diabetes management.
The EASD meeting will take place Sept. 19-23 in Stockholm. It will be the first in-person meeting since 2019 but will also feature live-streamed content for participants around the world.
“The EASD congress will cover all the different areas and aspects of diabetes research – clinical, basic, epidemiologic, and psychological,” EASD President Stefano Del Prato, MD, told this news organization.
What attendees should expect, said Del Prato of the University of Pisa (Italy), “is the pleasure to be able to participate in person at a meeting and get useful information, not only in terms of the knowledge and intellectual aspects of diabetes, but also something that can be implemented the following day in their daily clinical activities.”
EASD Honorary Secretary Mikael Rydén, MD, added: “I think meeting attendees will really be able to get the absolutely latest developments in all the areas that are relevant to diabetes treatments. It’s the best way to keep yourself up to date.”
This year, in particular, there’s a focus on past, present, and future trends in type 2 diabetes management, along with the co-occurring conditions of obesity, heart failure, and metabolic fatty liver disease.
DELIVER: The diabetes side
On Sept. 22, new data will be presented from the DELIVER trial on the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga) in patients with heart failure with preserved ejection fraction, comparing data for participants with diabetes, prediabetes, and normoglycemia.
Primary results from DELIVER were presented Aug. 26 at the European Society of Cardiology Congress 2022 in Barcelona and simultaneously published in the New England Journal of Medicine. The results showed that dapagliflozin benefits patients with heart failure with preserved ejection fraction, as previously demonstrated in those with reduced ejection fraction in the DAPA-HF trial.
“This information is quite important and is becoming of major interest in the field of diabetes,” Dr. Del Prato said, adding that a related joint EASD/ESC symposium will take place the next morning, on Sept. 23, entitled, “New perspectives on heart function and failure in diabetes.”
“So, within the congress, you get the background, pathophysiology, the diagnostic aspects, and the results of the effect of dapagliflozin on those individuals.”
Dr. Rydén commented, “I think this underlines how important it is for diabetologists to screen our patients better for heart failure because we can actually treat them now.”
However, Dr. Rydén of the Karolinska Institute, Stockholm, also cautioned about use of SGLT2 inhibitors in people with diabetes who use insulin, given the risk of euglycemic diabetic ketoacidosis. “These drugs have side effects and you have to be wary who you prescribe them to. For those on multiple daily [insulin] injections, the side effects probably outweigh the benefits.”
Tirzepatide, weight loss, and type 2 diabetes remission
On Sept. 21, a symposium will provide new data for the dual glucagonlike peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) agonist tirzepatide, approved for the treatment of type 2 diabetes in the United States in May with the brand name Mounjaro. The agent is now being studied as an obesity treatment.
Data from the SURMOUNT-1 trial presented at the ADA meeting in June showed the drug produced “unprecedented” weight loss of up to 22.5%.
At EASD, those findings will be reviewed and new data presented on morbidity and mortality, along with a new commentary. The degree of weight loss seen with this new twincretin has furthered discussion about the concept of remission in type 2 diabetes, Dr. Rydén noted. That will also be the subject of the Diabetologia symposium on Sept. 21, entitled, “Remission of type 2 diabetes – fact or fiction?”
Regarding tirzepatide, Dr. Rydén said: “It’s amazing, the most powerful antiobesity drug we have at our disposal. These drugs slow gastric emptying and have other beneficial effects. … We’re now closing in on drugs that produce more than 15% weight loss. That appears to be the ‘magic bullet’ where you can achieve type 2 diabetes remission.” He pointed to a symposium sponsored by The Lancet on this topic at last year’s EASD meeting.
“I think what we want with our drugs is not to treat but actually to combat type 2 diabetes and really to achieve remission. Of course, if you’ve had it for many decades that might be impossible, but we know that particularly in the first 5-10 years it’s very important to have good glucose control and we know we can also achieve remission.”
Dr. Del Prato noted the importance of weight reduction at the time of type 2 diabetes diagnosis will be emphasized in the ADA/EASD consensus document on the management of hyperglycemia in type 2 diabetes, to be presented in its final form on Sept. 23.
“I think we’ll be learning more about potential remission in the future, both because of metabolic surgery and agents like tirzepatide. The reduction in body weight that can be achieved [with these newer drugs], or that has been reported so far, is the closest to what can be obtained with metabolic surgery. I think there will be more and more information and a lot of discussion about this, and of course about the definition of remission and what to do after remission has occurred,” Dr. Del Prato said.
The revised ADA/EASD consensus document is expected to endorse weight loss as a “co-primary goal” of care for those without cardiorenal disease, along with early initiation of combination therapies – for example, taking two drugs immediately upon diagnosis, rather than just metformin – as opposed to the prior stepwise approach. The document will also cover use of newer glucose-lowering therapies, surgery, and behavioral interventions.
The key is a holistic approach, Dr. Del Prato said. “Of course, glucose control is important, but it’s not the only thing. The heterogeneity of the population with diabetes is also important. Some may already have microvascular complications, kidney dysfunction, are more or less obese, and older or younger. We need to keep these differences in mind to provide more and more individualized treatment.”
Related to that, he noted, will be a joint EASD/ADA symposium on Sept. 19, entitled, “Precision medicine in type 2 diabetes: How far can we get?”
COVID-19 and diabetes, UKPDS, type 1 diabetes, and much more
As always, there’s a whole lot more. On Sept. 21, there will be a symposium on COVID-19 and diabetes.
Another, on diabetes technology, has a somewhat cautionary theme: “A new hope (Star Wars) or strange new worlds (Star Trek): Submerging diabetes into emerging technologies.” One of the speakers will address the question: “Are we becoming robots? Automated insulin delivery (AID) systems for everyone with type 1 diabetes: Strengths and limitations.” And this year’s EASD/JDRF symposium topic will be prevention of type 1 diabetes.
Yet another symposium on Sept. 21 will present 44-year follow-up data from the landmark United Kingdom Prospective Diabetes Study (UKPDS), including an economic analysis and a look at dementia outcomes. “It’s a historical thing. This big trial represents a gold mine of information,” Dr. Del Prato commented.
On Sept. 22, new data will be presented for the investigational once-weekly insulins during a symposium entitled, “Re-inventing the insulin experience: Exploring the prospects of once-weekly insulins.”
And lest anyone was thinking of leaving the conference early, there’s a full agenda on Sept. 23, including symposia on diabetic nephropathy, type 1 diabetes, diabetes in old age, dietary management, and the role of primary care, among others. There will also be 12 separate oral presentation sessions that day.
Overall, the meeting will reflect the multidisciplinary direction the field is headed, Dr. Rydén said.
“We’re still in an era of medicine where a lot of things happen every year. Now we have the next generation of drugs that are coming that combine many areas of treatment – obesity, cardiology, and nephrology. So, we’re integrating. The future is integrating the diabetes world with our friends in other areas of clinical medicine.”
Dr. Del Prato has reported being a consultant, advisory board member, and/or lecturer for AstraZeneca, Boehringer Ingelheim, Novo Nordisk, Sanofi, Takeda, Eli Lilly, Abbott, and Applied Therapeutics. Dr. Rydén has reported receiving lecture fees from the Novo Nordisk Foundation and serving on advisory boards for MSD, Lilly, Boehringer Ingelheim, and AstraZeneca.
A version of this article first appeared on Medscape.com.
Highlights of the European Association for the Study of Diabetes 2022 annual meeting include new data on weight loss with the blockbuster twincretin tirzepatide and on the effects of dapagliflozin on heart failure in people with diabetes, as well as updated guidelines for type 2 diabetes management.
The EASD meeting will take place Sept. 19-23 in Stockholm. It will be the first in-person meeting since 2019 but will also feature live-streamed content for participants around the world.
“The EASD congress will cover all the different areas and aspects of diabetes research – clinical, basic, epidemiologic, and psychological,” EASD President Stefano Del Prato, MD, told this news organization.
What attendees should expect, said Del Prato of the University of Pisa (Italy), “is the pleasure to be able to participate in person at a meeting and get useful information, not only in terms of the knowledge and intellectual aspects of diabetes, but also something that can be implemented the following day in their daily clinical activities.”
EASD Honorary Secretary Mikael Rydén, MD, added: “I think meeting attendees will really be able to get the absolutely latest developments in all the areas that are relevant to diabetes treatments. It’s the best way to keep yourself up to date.”
This year, in particular, there’s a focus on past, present, and future trends in type 2 diabetes management, along with the co-occurring conditions of obesity, heart failure, and metabolic fatty liver disease.
DELIVER: The diabetes side
On Sept. 22, new data will be presented from the DELIVER trial on the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga) in patients with heart failure with preserved ejection fraction, comparing data for participants with diabetes, prediabetes, and normoglycemia.
Primary results from DELIVER were presented Aug. 26 at the European Society of Cardiology Congress 2022 in Barcelona and simultaneously published in the New England Journal of Medicine. The results showed that dapagliflozin benefits patients with heart failure with preserved ejection fraction, as previously demonstrated in those with reduced ejection fraction in the DAPA-HF trial.
“This information is quite important and is becoming of major interest in the field of diabetes,” Dr. Del Prato said, adding that a related joint EASD/ESC symposium will take place the next morning, on Sept. 23, entitled, “New perspectives on heart function and failure in diabetes.”
“So, within the congress, you get the background, pathophysiology, the diagnostic aspects, and the results of the effect of dapagliflozin on those individuals.”
Dr. Rydén commented, “I think this underlines how important it is for diabetologists to screen our patients better for heart failure because we can actually treat them now.”
However, Dr. Rydén of the Karolinska Institute, Stockholm, also cautioned about use of SGLT2 inhibitors in people with diabetes who use insulin, given the risk of euglycemic diabetic ketoacidosis. “These drugs have side effects and you have to be wary who you prescribe them to. For those on multiple daily [insulin] injections, the side effects probably outweigh the benefits.”
Tirzepatide, weight loss, and type 2 diabetes remission
On Sept. 21, a symposium will provide new data for the dual glucagonlike peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) agonist tirzepatide, approved for the treatment of type 2 diabetes in the United States in May with the brand name Mounjaro. The agent is now being studied as an obesity treatment.
Data from the SURMOUNT-1 trial presented at the ADA meeting in June showed the drug produced “unprecedented” weight loss of up to 22.5%.
At EASD, those findings will be reviewed and new data presented on morbidity and mortality, along with a new commentary. The degree of weight loss seen with this new twincretin has furthered discussion about the concept of remission in type 2 diabetes, Dr. Rydén noted. That will also be the subject of the Diabetologia symposium on Sept. 21, entitled, “Remission of type 2 diabetes – fact or fiction?”
Regarding tirzepatide, Dr. Rydén said: “It’s amazing, the most powerful antiobesity drug we have at our disposal. These drugs slow gastric emptying and have other beneficial effects. … We’re now closing in on drugs that produce more than 15% weight loss. That appears to be the ‘magic bullet’ where you can achieve type 2 diabetes remission.” He pointed to a symposium sponsored by The Lancet on this topic at last year’s EASD meeting.
“I think what we want with our drugs is not to treat but actually to combat type 2 diabetes and really to achieve remission. Of course, if you’ve had it for many decades that might be impossible, but we know that particularly in the first 5-10 years it’s very important to have good glucose control and we know we can also achieve remission.”
Dr. Del Prato noted the importance of weight reduction at the time of type 2 diabetes diagnosis will be emphasized in the ADA/EASD consensus document on the management of hyperglycemia in type 2 diabetes, to be presented in its final form on Sept. 23.
“I think we’ll be learning more about potential remission in the future, both because of metabolic surgery and agents like tirzepatide. The reduction in body weight that can be achieved [with these newer drugs], or that has been reported so far, is the closest to what can be obtained with metabolic surgery. I think there will be more and more information and a lot of discussion about this, and of course about the definition of remission and what to do after remission has occurred,” Dr. Del Prato said.
The revised ADA/EASD consensus document is expected to endorse weight loss as a “co-primary goal” of care for those without cardiorenal disease, along with early initiation of combination therapies – for example, taking two drugs immediately upon diagnosis, rather than just metformin – as opposed to the prior stepwise approach. The document will also cover use of newer glucose-lowering therapies, surgery, and behavioral interventions.
The key is a holistic approach, Dr. Del Prato said. “Of course, glucose control is important, but it’s not the only thing. The heterogeneity of the population with diabetes is also important. Some may already have microvascular complications, kidney dysfunction, are more or less obese, and older or younger. We need to keep these differences in mind to provide more and more individualized treatment.”
Related to that, he noted, will be a joint EASD/ADA symposium on Sept. 19, entitled, “Precision medicine in type 2 diabetes: How far can we get?”
COVID-19 and diabetes, UKPDS, type 1 diabetes, and much more
As always, there’s a whole lot more. On Sept. 21, there will be a symposium on COVID-19 and diabetes.
Another, on diabetes technology, has a somewhat cautionary theme: “A new hope (Star Wars) or strange new worlds (Star Trek): Submerging diabetes into emerging technologies.” One of the speakers will address the question: “Are we becoming robots? Automated insulin delivery (AID) systems for everyone with type 1 diabetes: Strengths and limitations.” And this year’s EASD/JDRF symposium topic will be prevention of type 1 diabetes.
Yet another symposium on Sept. 21 will present 44-year follow-up data from the landmark United Kingdom Prospective Diabetes Study (UKPDS), including an economic analysis and a look at dementia outcomes. “It’s a historical thing. This big trial represents a gold mine of information,” Dr. Del Prato commented.
On Sept. 22, new data will be presented for the investigational once-weekly insulins during a symposium entitled, “Re-inventing the insulin experience: Exploring the prospects of once-weekly insulins.”
And lest anyone was thinking of leaving the conference early, there’s a full agenda on Sept. 23, including symposia on diabetic nephropathy, type 1 diabetes, diabetes in old age, dietary management, and the role of primary care, among others. There will also be 12 separate oral presentation sessions that day.
Overall, the meeting will reflect the multidisciplinary direction the field is headed, Dr. Rydén said.
“We’re still in an era of medicine where a lot of things happen every year. Now we have the next generation of drugs that are coming that combine many areas of treatment – obesity, cardiology, and nephrology. So, we’re integrating. The future is integrating the diabetes world with our friends in other areas of clinical medicine.”
Dr. Del Prato has reported being a consultant, advisory board member, and/or lecturer for AstraZeneca, Boehringer Ingelheim, Novo Nordisk, Sanofi, Takeda, Eli Lilly, Abbott, and Applied Therapeutics. Dr. Rydén has reported receiving lecture fees from the Novo Nordisk Foundation and serving on advisory boards for MSD, Lilly, Boehringer Ingelheim, and AstraZeneca.
A version of this article first appeared on Medscape.com.
Highlights of the European Association for the Study of Diabetes 2022 annual meeting include new data on weight loss with the blockbuster twincretin tirzepatide and on the effects of dapagliflozin on heart failure in people with diabetes, as well as updated guidelines for type 2 diabetes management.
The EASD meeting will take place Sept. 19-23 in Stockholm. It will be the first in-person meeting since 2019 but will also feature live-streamed content for participants around the world.
“The EASD congress will cover all the different areas and aspects of diabetes research – clinical, basic, epidemiologic, and psychological,” EASD President Stefano Del Prato, MD, told this news organization.
What attendees should expect, said Del Prato of the University of Pisa (Italy), “is the pleasure to be able to participate in person at a meeting and get useful information, not only in terms of the knowledge and intellectual aspects of diabetes, but also something that can be implemented the following day in their daily clinical activities.”
EASD Honorary Secretary Mikael Rydén, MD, added: “I think meeting attendees will really be able to get the absolutely latest developments in all the areas that are relevant to diabetes treatments. It’s the best way to keep yourself up to date.”
This year, in particular, there’s a focus on past, present, and future trends in type 2 diabetes management, along with the co-occurring conditions of obesity, heart failure, and metabolic fatty liver disease.
DELIVER: The diabetes side
On Sept. 22, new data will be presented from the DELIVER trial on the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga) in patients with heart failure with preserved ejection fraction, comparing data for participants with diabetes, prediabetes, and normoglycemia.
Primary results from DELIVER were presented Aug. 26 at the European Society of Cardiology Congress 2022 in Barcelona and simultaneously published in the New England Journal of Medicine. The results showed that dapagliflozin benefits patients with heart failure with preserved ejection fraction, as previously demonstrated in those with reduced ejection fraction in the DAPA-HF trial.
“This information is quite important and is becoming of major interest in the field of diabetes,” Dr. Del Prato said, adding that a related joint EASD/ESC symposium will take place the next morning, on Sept. 23, entitled, “New perspectives on heart function and failure in diabetes.”
“So, within the congress, you get the background, pathophysiology, the diagnostic aspects, and the results of the effect of dapagliflozin on those individuals.”
Dr. Rydén commented, “I think this underlines how important it is for diabetologists to screen our patients better for heart failure because we can actually treat them now.”
However, Dr. Rydén of the Karolinska Institute, Stockholm, also cautioned about use of SGLT2 inhibitors in people with diabetes who use insulin, given the risk of euglycemic diabetic ketoacidosis. “These drugs have side effects and you have to be wary who you prescribe them to. For those on multiple daily [insulin] injections, the side effects probably outweigh the benefits.”
Tirzepatide, weight loss, and type 2 diabetes remission
On Sept. 21, a symposium will provide new data for the dual glucagonlike peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) agonist tirzepatide, approved for the treatment of type 2 diabetes in the United States in May with the brand name Mounjaro. The agent is now being studied as an obesity treatment.
Data from the SURMOUNT-1 trial presented at the ADA meeting in June showed the drug produced “unprecedented” weight loss of up to 22.5%.
At EASD, those findings will be reviewed and new data presented on morbidity and mortality, along with a new commentary. The degree of weight loss seen with this new twincretin has furthered discussion about the concept of remission in type 2 diabetes, Dr. Rydén noted. That will also be the subject of the Diabetologia symposium on Sept. 21, entitled, “Remission of type 2 diabetes – fact or fiction?”
Regarding tirzepatide, Dr. Rydén said: “It’s amazing, the most powerful antiobesity drug we have at our disposal. These drugs slow gastric emptying and have other beneficial effects. … We’re now closing in on drugs that produce more than 15% weight loss. That appears to be the ‘magic bullet’ where you can achieve type 2 diabetes remission.” He pointed to a symposium sponsored by The Lancet on this topic at last year’s EASD meeting.
“I think what we want with our drugs is not to treat but actually to combat type 2 diabetes and really to achieve remission. Of course, if you’ve had it for many decades that might be impossible, but we know that particularly in the first 5-10 years it’s very important to have good glucose control and we know we can also achieve remission.”
Dr. Del Prato noted the importance of weight reduction at the time of type 2 diabetes diagnosis will be emphasized in the ADA/EASD consensus document on the management of hyperglycemia in type 2 diabetes, to be presented in its final form on Sept. 23.
“I think we’ll be learning more about potential remission in the future, both because of metabolic surgery and agents like tirzepatide. The reduction in body weight that can be achieved [with these newer drugs], or that has been reported so far, is the closest to what can be obtained with metabolic surgery. I think there will be more and more information and a lot of discussion about this, and of course about the definition of remission and what to do after remission has occurred,” Dr. Del Prato said.
The revised ADA/EASD consensus document is expected to endorse weight loss as a “co-primary goal” of care for those without cardiorenal disease, along with early initiation of combination therapies – for example, taking two drugs immediately upon diagnosis, rather than just metformin – as opposed to the prior stepwise approach. The document will also cover use of newer glucose-lowering therapies, surgery, and behavioral interventions.
The key is a holistic approach, Dr. Del Prato said. “Of course, glucose control is important, but it’s not the only thing. The heterogeneity of the population with diabetes is also important. Some may already have microvascular complications, kidney dysfunction, are more or less obese, and older or younger. We need to keep these differences in mind to provide more and more individualized treatment.”
Related to that, he noted, will be a joint EASD/ADA symposium on Sept. 19, entitled, “Precision medicine in type 2 diabetes: How far can we get?”
COVID-19 and diabetes, UKPDS, type 1 diabetes, and much more
As always, there’s a whole lot more. On Sept. 21, there will be a symposium on COVID-19 and diabetes.
Another, on diabetes technology, has a somewhat cautionary theme: “A new hope (Star Wars) or strange new worlds (Star Trek): Submerging diabetes into emerging technologies.” One of the speakers will address the question: “Are we becoming robots? Automated insulin delivery (AID) systems for everyone with type 1 diabetes: Strengths and limitations.” And this year’s EASD/JDRF symposium topic will be prevention of type 1 diabetes.
Yet another symposium on Sept. 21 will present 44-year follow-up data from the landmark United Kingdom Prospective Diabetes Study (UKPDS), including an economic analysis and a look at dementia outcomes. “It’s a historical thing. This big trial represents a gold mine of information,” Dr. Del Prato commented.
On Sept. 22, new data will be presented for the investigational once-weekly insulins during a symposium entitled, “Re-inventing the insulin experience: Exploring the prospects of once-weekly insulins.”
And lest anyone was thinking of leaving the conference early, there’s a full agenda on Sept. 23, including symposia on diabetic nephropathy, type 1 diabetes, diabetes in old age, dietary management, and the role of primary care, among others. There will also be 12 separate oral presentation sessions that day.
Overall, the meeting will reflect the multidisciplinary direction the field is headed, Dr. Rydén said.
“We’re still in an era of medicine where a lot of things happen every year. Now we have the next generation of drugs that are coming that combine many areas of treatment – obesity, cardiology, and nephrology. So, we’re integrating. The future is integrating the diabetes world with our friends in other areas of clinical medicine.”
Dr. Del Prato has reported being a consultant, advisory board member, and/or lecturer for AstraZeneca, Boehringer Ingelheim, Novo Nordisk, Sanofi, Takeda, Eli Lilly, Abbott, and Applied Therapeutics. Dr. Rydén has reported receiving lecture fees from the Novo Nordisk Foundation and serving on advisory boards for MSD, Lilly, Boehringer Ingelheim, and AstraZeneca.
A version of this article first appeared on Medscape.com.
COVID-19 linked to increased Alzheimer’s risk
The study of more than 6 million people aged 65 years or older found a 50%-80% increased risk for AD in the year after COVID-19; the risk was especially high for women older than 85 years.
However, the investigators were quick to point out that the observational retrospective study offers no evidence that COVID-19 causes AD. There could be a viral etiology at play, or the connection could be related to inflammation in neural tissue from the SARS-CoV-2 infection. Or it could simply be that exposure to the health care system for COVID-19 increased the odds of detection of existing undiagnosed AD cases.
Whatever the case, these findings point to a potential spike in AD cases, which is a cause for concern, study investigator Pamela Davis, MD, PhD, a professor in the Center for Community Health Integration at Case Western Reserve University, Cleveland, said in an interview.
“COVID may be giving us a legacy of ongoing medical difficulties,” Dr. Davis said. “We were already concerned about having a very large care burden and cost burden from Alzheimer’s disease. If this is another burden that’s increased by COVID, this is something we’re really going to have to prepare for.”
The findings were published online in Journal of Alzheimer’s Disease.
Increased risk
Earlier research points to a potential link between COVID-19 and increased risk for AD and Parkinson’s disease.
For the current study, researchers analyzed anonymous electronic health records of 6.2 million adults aged 65 years or older who received medical treatment between February 2020 and May 2021 and had no prior diagnosis of AD. The database includes information on almost 30% of the entire U.S. population.
Overall, there were 410,748 cases of COVID-19 during the study period.
The overall risk for new diagnosis of AD in the COVID-19 cohort was close to double that of those who did not have COVID-19 (0.68% vs. 0.35%, respectively).
After propensity-score matching, those who have had COVID-19 had a significantly higher risk for an AD diagnosis compared with those who were not infected (hazard ratio [HR], 1.69; 95% confidence interval [CI],1.53-1.72).
Risk for AD was elevated in all age groups, regardless of gender or ethnicity. Researchers did not collect data on COVID-19 severity, and the medical codes for long COVID were not published until after the study had ended.
Those with the highest risk were individuals older than 85 years (HR, 1.89; 95% CI, 1.73-2.07) and women (HR, 1.82; 95% CI, 1.69-1.97).
“We expected to see some impact, but I was surprised that it was as potent as it was,” Dr. Davis said.
Association, not causation
Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, who commented on the findings for this article, called the study interesting but emphasized caution in interpreting the results.
“Because this study only showed an association through medical records, we cannot know what the underlying mechanisms driving this association are without more research,” Dr. Snyder said. “If you have had COVID-19, it doesn’t mean you’re going to get dementia. But if you have had COVID-19 and are experiencing long-term symptoms including cognitive difficulties, talk to your doctor.”
Dr. Davis agreed, noting that this type of study offers information on association, but not causation. “I do think that this makes it imperative that we continue to follow the population for what’s going on in various neurodegenerative diseases,” Dr. Davis said.
The study was funded by the National Institute of Aging, National Institute on Alcohol Abuse and Alcoholism, the Clinical and Translational Science Collaborative of Cleveland, and the National Cancer Institute. Dr. Synder reports no relevant financial conflicts.
A version of this article first appeared on Medscape.com.
The study of more than 6 million people aged 65 years or older found a 50%-80% increased risk for AD in the year after COVID-19; the risk was especially high for women older than 85 years.
However, the investigators were quick to point out that the observational retrospective study offers no evidence that COVID-19 causes AD. There could be a viral etiology at play, or the connection could be related to inflammation in neural tissue from the SARS-CoV-2 infection. Or it could simply be that exposure to the health care system for COVID-19 increased the odds of detection of existing undiagnosed AD cases.
Whatever the case, these findings point to a potential spike in AD cases, which is a cause for concern, study investigator Pamela Davis, MD, PhD, a professor in the Center for Community Health Integration at Case Western Reserve University, Cleveland, said in an interview.
“COVID may be giving us a legacy of ongoing medical difficulties,” Dr. Davis said. “We were already concerned about having a very large care burden and cost burden from Alzheimer’s disease. If this is another burden that’s increased by COVID, this is something we’re really going to have to prepare for.”
The findings were published online in Journal of Alzheimer’s Disease.
Increased risk
Earlier research points to a potential link between COVID-19 and increased risk for AD and Parkinson’s disease.
For the current study, researchers analyzed anonymous electronic health records of 6.2 million adults aged 65 years or older who received medical treatment between February 2020 and May 2021 and had no prior diagnosis of AD. The database includes information on almost 30% of the entire U.S. population.
Overall, there were 410,748 cases of COVID-19 during the study period.
The overall risk for new diagnosis of AD in the COVID-19 cohort was close to double that of those who did not have COVID-19 (0.68% vs. 0.35%, respectively).
After propensity-score matching, those who have had COVID-19 had a significantly higher risk for an AD diagnosis compared with those who were not infected (hazard ratio [HR], 1.69; 95% confidence interval [CI],1.53-1.72).
Risk for AD was elevated in all age groups, regardless of gender or ethnicity. Researchers did not collect data on COVID-19 severity, and the medical codes for long COVID were not published until after the study had ended.
Those with the highest risk were individuals older than 85 years (HR, 1.89; 95% CI, 1.73-2.07) and women (HR, 1.82; 95% CI, 1.69-1.97).
“We expected to see some impact, but I was surprised that it was as potent as it was,” Dr. Davis said.
Association, not causation
Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, who commented on the findings for this article, called the study interesting but emphasized caution in interpreting the results.
“Because this study only showed an association through medical records, we cannot know what the underlying mechanisms driving this association are without more research,” Dr. Snyder said. “If you have had COVID-19, it doesn’t mean you’re going to get dementia. But if you have had COVID-19 and are experiencing long-term symptoms including cognitive difficulties, talk to your doctor.”
Dr. Davis agreed, noting that this type of study offers information on association, but not causation. “I do think that this makes it imperative that we continue to follow the population for what’s going on in various neurodegenerative diseases,” Dr. Davis said.
The study was funded by the National Institute of Aging, National Institute on Alcohol Abuse and Alcoholism, the Clinical and Translational Science Collaborative of Cleveland, and the National Cancer Institute. Dr. Synder reports no relevant financial conflicts.
A version of this article first appeared on Medscape.com.
The study of more than 6 million people aged 65 years or older found a 50%-80% increased risk for AD in the year after COVID-19; the risk was especially high for women older than 85 years.
However, the investigators were quick to point out that the observational retrospective study offers no evidence that COVID-19 causes AD. There could be a viral etiology at play, or the connection could be related to inflammation in neural tissue from the SARS-CoV-2 infection. Or it could simply be that exposure to the health care system for COVID-19 increased the odds of detection of existing undiagnosed AD cases.
Whatever the case, these findings point to a potential spike in AD cases, which is a cause for concern, study investigator Pamela Davis, MD, PhD, a professor in the Center for Community Health Integration at Case Western Reserve University, Cleveland, said in an interview.
“COVID may be giving us a legacy of ongoing medical difficulties,” Dr. Davis said. “We were already concerned about having a very large care burden and cost burden from Alzheimer’s disease. If this is another burden that’s increased by COVID, this is something we’re really going to have to prepare for.”
The findings were published online in Journal of Alzheimer’s Disease.
Increased risk
Earlier research points to a potential link between COVID-19 and increased risk for AD and Parkinson’s disease.
For the current study, researchers analyzed anonymous electronic health records of 6.2 million adults aged 65 years or older who received medical treatment between February 2020 and May 2021 and had no prior diagnosis of AD. The database includes information on almost 30% of the entire U.S. population.
Overall, there were 410,748 cases of COVID-19 during the study period.
The overall risk for new diagnosis of AD in the COVID-19 cohort was close to double that of those who did not have COVID-19 (0.68% vs. 0.35%, respectively).
After propensity-score matching, those who have had COVID-19 had a significantly higher risk for an AD diagnosis compared with those who were not infected (hazard ratio [HR], 1.69; 95% confidence interval [CI],1.53-1.72).
Risk for AD was elevated in all age groups, regardless of gender or ethnicity. Researchers did not collect data on COVID-19 severity, and the medical codes for long COVID were not published until after the study had ended.
Those with the highest risk were individuals older than 85 years (HR, 1.89; 95% CI, 1.73-2.07) and women (HR, 1.82; 95% CI, 1.69-1.97).
“We expected to see some impact, but I was surprised that it was as potent as it was,” Dr. Davis said.
Association, not causation
Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, who commented on the findings for this article, called the study interesting but emphasized caution in interpreting the results.
“Because this study only showed an association through medical records, we cannot know what the underlying mechanisms driving this association are without more research,” Dr. Snyder said. “If you have had COVID-19, it doesn’t mean you’re going to get dementia. But if you have had COVID-19 and are experiencing long-term symptoms including cognitive difficulties, talk to your doctor.”
Dr. Davis agreed, noting that this type of study offers information on association, but not causation. “I do think that this makes it imperative that we continue to follow the population for what’s going on in various neurodegenerative diseases,” Dr. Davis said.
The study was funded by the National Institute of Aging, National Institute on Alcohol Abuse and Alcoholism, the Clinical and Translational Science Collaborative of Cleveland, and the National Cancer Institute. Dr. Synder reports no relevant financial conflicts.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF ALZHEIMER’S DISEASE
BRAF/MEK combo shows long-term efficacy in melanoma
, according to 5-year follow-up data from the COLUMBUS trial. Among patients with advanced unresectable or metastatic disease who were untreated or who had progressed following immunotherapy, the regimen of encorafenib plus binimetinib produced impressive gains in progression-free and overall survival, compared with historical controls, and are in line with other BRAF/MEK inhibitor combinations. It also outperformed encorafenib and vemurafenib monotherapy regimens.
The findings present good news, but the combination still doesn’t represent the best first-line option, according to Ryan Sullivan, MD, who wrote an accompanying editorial. He pointed out that the previously published DREAMSeq trial showed that a combination of immune checkpoint inhibitors (ICIs) ipilimumab and nivolumab produced a 2-year survival of 72%, compared with 52% for a BRAF inhibitor combination of dabrafenib plus trametinib (P = .0095).
There are three combinations of BRAF and MEK inhibitors that are approved for BRAF mutant melanoma, and any of the seven individual agents and six combinations that are approved by the U.S. Food and Drug Administration- for melanoma can be used in BRAFV600 patients. “The standard of care for most patients with newly diagnosed BRAF mutant melanoma is ... immune checkpoint inhibition, either with anti–PD-1 inhibitor or a combination of immunotherapy with an anti–PD-1 inhibitor. The optimal use of BRAF targeted therapy is unknown but some data supports its use earlier in the disease course (adjuvant setting) or after progression following anti–PD-1 therapy in the advanced disease setting,” wrote Dr. Sullivan in an email. He is associate director of the melanoma program at Massachusetts General Hospital, Boston.
The new study was published online in the Journal of Clinical Oncology.
In his editorial, Dr. Sullivan wrote that anti–PD-1 monoclonal antibodies alone or in combination with anti-CTLA4 receptor therapies is likely the best front-line therapy for BRAFV600 mutant advanced melanoma, with long-term survival ranging from 40% to 50%.
Still, the efficacy of BRAF-targeted therapy makes it important to explore ways to strengthen it further. One possibility is to use it in the front-line setting when a patient is at high risk of rapid progression and death, since analysis from DREAMSeq showed that BRAF-targeted therapy had a better overall survival than immunotherapy during the first 10 months after random assignment. It was only after this time point that the curves reversed and pointed to greater efficacy for immunotherapy. An option would be to treat to maximum tumor regression with BRAF-targeted therapy and then switch to immunotherapy, according to Dr. Sullivan. That point was echoed by study author Paolo Ascierto, MD, in an email exchange. “For patients with symptomatic disease or very high tumor burden, BRAF/MEK inhibitor should be used first,” said Dr. Ascierto, who is director of the melanoma cancer immunotherapy innovative therapy unit of the National Tumor Institute in Naples, Italy.
BRAF inhibitors as second- or later-line therapy
Aside from that exception, BRAF inhibitors should generally be reserved for second- or later-line therapy, according to Dr. Sullivan. Retrospective data indicate that response to BRAF inhibitors is preserved following immunotherapy, although the duration of benefit is reduced. Unfortunately, that strategy limits BRAF inhibitors to a setting in which they’re less likely to be maximally effective.
To improve matters, Dr. Sullivan suggested that they could be used in the adjuvant setting, where disease burden is lower. He noted that dabrafenib and trametinib are approved for resected stage 3 melanoma and showed similar efficacy to immunotherapy in that setting. Immunotherapy retains efficacy after BRAF-targeted therapy.
Another potential strategy is to come up with 3- or even 4-drug combinations employing BRAF/MEK inhibitors in the second-line setting. A few trials have already begun to investigate this possibility.
The COLUMBUS trial included 192 patients who received encorafenib plus binimetinib (E+B), 191 who received vemurafenib and 194 who received encorafenib. Five-year progression-free survival (PFS) was 23% in the E+B group, and 31% in those with normal lactate dehydrogenase levels. Five-year PFS was 10% with vemurafenib alone (12% with normal lactate dehydrogenase). Progression free survival (PFS) was 19% in the encorafenib group. Five-year overall survival (OS) followed a similar trend: 35% (45% with normal lactate dehydrogenase) in the E+B group, and 21% (28%) in the vemurafenib group. E+B had a median duration of response of 18.6 months, and a disease control rate of 92.2%, compared with 12.3 months and 81.2% with vemurafenib. Median duration of response was 15.5 months in the encorafenib monotherapy group.
The COLUMBUS trial was sponsored by Array BioPharma, which was acquired by Pfizer in July 2019.
Dr. Sullivan has consulted or advised Novartis, Merck, Replimune, Asana Biosciences, Alkermes, Eisai, Pfizer, Iovance Biotherapeutics, OncoSec, AstraZeneca, and Bristol Myers Squibb. Dr. Ascierto has stock or an ownership position in PrimeVax. He has consulted or advised for Bristol Myers Squibb, Roche/Genentech, Merck Sharp & Dohme, Novartis, Array BioPharma, Merck Serono, Pierre Fabre, Incyte, MedImmune, AstraZeneca, Sun Pharma, Sanofi, Idera, Ultimovacs, Sandoz, Immunocore, 4SC, Alkermes, Italfarmaco, Nektar, Boehringer Ingelheim, Eisai, Regeneron, Daiichi Sankyo, Pfizer, OncoSec, Nouscom, Takis Biotech, Lunaphore Technologies, Seattle Genetics, ITeos Therapeutics, Medicenna, and Bio-Al Health.
, according to 5-year follow-up data from the COLUMBUS trial. Among patients with advanced unresectable or metastatic disease who were untreated or who had progressed following immunotherapy, the regimen of encorafenib plus binimetinib produced impressive gains in progression-free and overall survival, compared with historical controls, and are in line with other BRAF/MEK inhibitor combinations. It also outperformed encorafenib and vemurafenib monotherapy regimens.
The findings present good news, but the combination still doesn’t represent the best first-line option, according to Ryan Sullivan, MD, who wrote an accompanying editorial. He pointed out that the previously published DREAMSeq trial showed that a combination of immune checkpoint inhibitors (ICIs) ipilimumab and nivolumab produced a 2-year survival of 72%, compared with 52% for a BRAF inhibitor combination of dabrafenib plus trametinib (P = .0095).
There are three combinations of BRAF and MEK inhibitors that are approved for BRAF mutant melanoma, and any of the seven individual agents and six combinations that are approved by the U.S. Food and Drug Administration- for melanoma can be used in BRAFV600 patients. “The standard of care for most patients with newly diagnosed BRAF mutant melanoma is ... immune checkpoint inhibition, either with anti–PD-1 inhibitor or a combination of immunotherapy with an anti–PD-1 inhibitor. The optimal use of BRAF targeted therapy is unknown but some data supports its use earlier in the disease course (adjuvant setting) or after progression following anti–PD-1 therapy in the advanced disease setting,” wrote Dr. Sullivan in an email. He is associate director of the melanoma program at Massachusetts General Hospital, Boston.
The new study was published online in the Journal of Clinical Oncology.
In his editorial, Dr. Sullivan wrote that anti–PD-1 monoclonal antibodies alone or in combination with anti-CTLA4 receptor therapies is likely the best front-line therapy for BRAFV600 mutant advanced melanoma, with long-term survival ranging from 40% to 50%.
Still, the efficacy of BRAF-targeted therapy makes it important to explore ways to strengthen it further. One possibility is to use it in the front-line setting when a patient is at high risk of rapid progression and death, since analysis from DREAMSeq showed that BRAF-targeted therapy had a better overall survival than immunotherapy during the first 10 months after random assignment. It was only after this time point that the curves reversed and pointed to greater efficacy for immunotherapy. An option would be to treat to maximum tumor regression with BRAF-targeted therapy and then switch to immunotherapy, according to Dr. Sullivan. That point was echoed by study author Paolo Ascierto, MD, in an email exchange. “For patients with symptomatic disease or very high tumor burden, BRAF/MEK inhibitor should be used first,” said Dr. Ascierto, who is director of the melanoma cancer immunotherapy innovative therapy unit of the National Tumor Institute in Naples, Italy.
BRAF inhibitors as second- or later-line therapy
Aside from that exception, BRAF inhibitors should generally be reserved for second- or later-line therapy, according to Dr. Sullivan. Retrospective data indicate that response to BRAF inhibitors is preserved following immunotherapy, although the duration of benefit is reduced. Unfortunately, that strategy limits BRAF inhibitors to a setting in which they’re less likely to be maximally effective.
To improve matters, Dr. Sullivan suggested that they could be used in the adjuvant setting, where disease burden is lower. He noted that dabrafenib and trametinib are approved for resected stage 3 melanoma and showed similar efficacy to immunotherapy in that setting. Immunotherapy retains efficacy after BRAF-targeted therapy.
Another potential strategy is to come up with 3- or even 4-drug combinations employing BRAF/MEK inhibitors in the second-line setting. A few trials have already begun to investigate this possibility.
The COLUMBUS trial included 192 patients who received encorafenib plus binimetinib (E+B), 191 who received vemurafenib and 194 who received encorafenib. Five-year progression-free survival (PFS) was 23% in the E+B group, and 31% in those with normal lactate dehydrogenase levels. Five-year PFS was 10% with vemurafenib alone (12% with normal lactate dehydrogenase). Progression free survival (PFS) was 19% in the encorafenib group. Five-year overall survival (OS) followed a similar trend: 35% (45% with normal lactate dehydrogenase) in the E+B group, and 21% (28%) in the vemurafenib group. E+B had a median duration of response of 18.6 months, and a disease control rate of 92.2%, compared with 12.3 months and 81.2% with vemurafenib. Median duration of response was 15.5 months in the encorafenib monotherapy group.
The COLUMBUS trial was sponsored by Array BioPharma, which was acquired by Pfizer in July 2019.
Dr. Sullivan has consulted or advised Novartis, Merck, Replimune, Asana Biosciences, Alkermes, Eisai, Pfizer, Iovance Biotherapeutics, OncoSec, AstraZeneca, and Bristol Myers Squibb. Dr. Ascierto has stock or an ownership position in PrimeVax. He has consulted or advised for Bristol Myers Squibb, Roche/Genentech, Merck Sharp & Dohme, Novartis, Array BioPharma, Merck Serono, Pierre Fabre, Incyte, MedImmune, AstraZeneca, Sun Pharma, Sanofi, Idera, Ultimovacs, Sandoz, Immunocore, 4SC, Alkermes, Italfarmaco, Nektar, Boehringer Ingelheim, Eisai, Regeneron, Daiichi Sankyo, Pfizer, OncoSec, Nouscom, Takis Biotech, Lunaphore Technologies, Seattle Genetics, ITeos Therapeutics, Medicenna, and Bio-Al Health.
, according to 5-year follow-up data from the COLUMBUS trial. Among patients with advanced unresectable or metastatic disease who were untreated or who had progressed following immunotherapy, the regimen of encorafenib plus binimetinib produced impressive gains in progression-free and overall survival, compared with historical controls, and are in line with other BRAF/MEK inhibitor combinations. It also outperformed encorafenib and vemurafenib monotherapy regimens.
The findings present good news, but the combination still doesn’t represent the best first-line option, according to Ryan Sullivan, MD, who wrote an accompanying editorial. He pointed out that the previously published DREAMSeq trial showed that a combination of immune checkpoint inhibitors (ICIs) ipilimumab and nivolumab produced a 2-year survival of 72%, compared with 52% for a BRAF inhibitor combination of dabrafenib plus trametinib (P = .0095).
There are three combinations of BRAF and MEK inhibitors that are approved for BRAF mutant melanoma, and any of the seven individual agents and six combinations that are approved by the U.S. Food and Drug Administration- for melanoma can be used in BRAFV600 patients. “The standard of care for most patients with newly diagnosed BRAF mutant melanoma is ... immune checkpoint inhibition, either with anti–PD-1 inhibitor or a combination of immunotherapy with an anti–PD-1 inhibitor. The optimal use of BRAF targeted therapy is unknown but some data supports its use earlier in the disease course (adjuvant setting) or after progression following anti–PD-1 therapy in the advanced disease setting,” wrote Dr. Sullivan in an email. He is associate director of the melanoma program at Massachusetts General Hospital, Boston.
The new study was published online in the Journal of Clinical Oncology.
In his editorial, Dr. Sullivan wrote that anti–PD-1 monoclonal antibodies alone or in combination with anti-CTLA4 receptor therapies is likely the best front-line therapy for BRAFV600 mutant advanced melanoma, with long-term survival ranging from 40% to 50%.
Still, the efficacy of BRAF-targeted therapy makes it important to explore ways to strengthen it further. One possibility is to use it in the front-line setting when a patient is at high risk of rapid progression and death, since analysis from DREAMSeq showed that BRAF-targeted therapy had a better overall survival than immunotherapy during the first 10 months after random assignment. It was only after this time point that the curves reversed and pointed to greater efficacy for immunotherapy. An option would be to treat to maximum tumor regression with BRAF-targeted therapy and then switch to immunotherapy, according to Dr. Sullivan. That point was echoed by study author Paolo Ascierto, MD, in an email exchange. “For patients with symptomatic disease or very high tumor burden, BRAF/MEK inhibitor should be used first,” said Dr. Ascierto, who is director of the melanoma cancer immunotherapy innovative therapy unit of the National Tumor Institute in Naples, Italy.
BRAF inhibitors as second- or later-line therapy
Aside from that exception, BRAF inhibitors should generally be reserved for second- or later-line therapy, according to Dr. Sullivan. Retrospective data indicate that response to BRAF inhibitors is preserved following immunotherapy, although the duration of benefit is reduced. Unfortunately, that strategy limits BRAF inhibitors to a setting in which they’re less likely to be maximally effective.
To improve matters, Dr. Sullivan suggested that they could be used in the adjuvant setting, where disease burden is lower. He noted that dabrafenib and trametinib are approved for resected stage 3 melanoma and showed similar efficacy to immunotherapy in that setting. Immunotherapy retains efficacy after BRAF-targeted therapy.
Another potential strategy is to come up with 3- or even 4-drug combinations employing BRAF/MEK inhibitors in the second-line setting. A few trials have already begun to investigate this possibility.
The COLUMBUS trial included 192 patients who received encorafenib plus binimetinib (E+B), 191 who received vemurafenib and 194 who received encorafenib. Five-year progression-free survival (PFS) was 23% in the E+B group, and 31% in those with normal lactate dehydrogenase levels. Five-year PFS was 10% with vemurafenib alone (12% with normal lactate dehydrogenase). Progression free survival (PFS) was 19% in the encorafenib group. Five-year overall survival (OS) followed a similar trend: 35% (45% with normal lactate dehydrogenase) in the E+B group, and 21% (28%) in the vemurafenib group. E+B had a median duration of response of 18.6 months, and a disease control rate of 92.2%, compared with 12.3 months and 81.2% with vemurafenib. Median duration of response was 15.5 months in the encorafenib monotherapy group.
The COLUMBUS trial was sponsored by Array BioPharma, which was acquired by Pfizer in July 2019.
Dr. Sullivan has consulted or advised Novartis, Merck, Replimune, Asana Biosciences, Alkermes, Eisai, Pfizer, Iovance Biotherapeutics, OncoSec, AstraZeneca, and Bristol Myers Squibb. Dr. Ascierto has stock or an ownership position in PrimeVax. He has consulted or advised for Bristol Myers Squibb, Roche/Genentech, Merck Sharp & Dohme, Novartis, Array BioPharma, Merck Serono, Pierre Fabre, Incyte, MedImmune, AstraZeneca, Sun Pharma, Sanofi, Idera, Ultimovacs, Sandoz, Immunocore, 4SC, Alkermes, Italfarmaco, Nektar, Boehringer Ingelheim, Eisai, Regeneron, Daiichi Sankyo, Pfizer, OncoSec, Nouscom, Takis Biotech, Lunaphore Technologies, Seattle Genetics, ITeos Therapeutics, Medicenna, and Bio-Al Health.
FROM JOURNAL OF CLINICAL ONCOLOGY
Vitamins or cocoa: Which preserves cognition?
Unexpected results from a phase 3 trial exploring the effect of multivitamins and cognition have now been published.
Originally presented last November at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) conference, this is the first large-scale, long-term randomized controlled trial to examine the effects of cocoa extract and multivitamins on global cognition. The trial’s primary focus was on cocoa extract, which earlier studies suggest may preserve cognitive function. Analyzing the effect of multivitamins was a secondary outcome.
Showing vitamins, but not cocoa, were beneficial is the exact opposite of what researchers expected. Still, the results offer an interesting new direction for future study, lead investigator Laura D. Baker, PhD, professor of gerontology and geriatric medicine at Wake Forest University, Winston-Salem, N.C., said in an interview.
“This study made us take notice of a pathway for possible cognitive protection,” Dr. Baker said. “Without this study, we would never have looked down that road.”
The full results were published online in Alzheimer’s and Dementia.
Unexpected effect
The COSMOS-Mind study is a substudy to a larger parent trial called COSMOS. It investigated the effects of cocoa extract and a standard multivitamin-mineral on cardiovascular and cancer outcomes in more than 21,000 older participants.
In COSMOS-Mind, researchers tested whether daily intake of cocoa extract vs. placebo and a multivitamin-mineral vs. placebo improved cognition in older adults.
More than 2,200 participants aged 65 and older were enrolled and followed for 3 years. They completed tests over the telephone at baseline and annually to evaluate memory and other cognitive abilities.
Results showed cocoa extract had no effect on global cognition compared with placebo (mean z-score, 0.03; P = .28). Daily multivitamin use, however, did show significant benefits on global cognition vs. placebo (mean z, 0.07, P = .007).
The beneficial effect was most pronounced in participants with a history of cardiovascular disease (no history 0.06 vs. history 0.14; P = .01).
Researchers found similar protective effects for memory and executive function.
Dr. Baker suggested one possible explanation for the positive effects of multivitamins may be the boost in micronutrients and essential minerals they provided.
“With nutrient-deficient diets plus a high prevalence of cardiovascular disease, diabetes, and other medical comorbidities that we know impact the bioavailability of these nutrients, we are possibly dealing with older adults who are at below optimum in terms of their essential micronutrients and minerals,” she said.
“Even suboptimum levels of micronutrients and essential minerals can have significant consequences for brain health,” she added.
More research needed
Intriguing as the results may be, more work is needed before the findings could affect nutritional guidance, according to Maria C. Carrillo, PhD, chief science officer for the Alzheimer’s Association.
“While the Alzheimer’s Association is encouraged by these results, we are not ready to recommend widespread use of a multivitamin supplement to reduce risk of cognitive decline in older adults,” Dr. Carrillo said in a statement.
“For now, and until there is more data, people should talk with their health care providers about the benefits and risks of all dietary supplements, including multivitamins,” she added.
Dr. Baker agreed, noting that the study was not designed to measure multivitamin use as a primary outcome. In addition, nearly 90% of the participants were non-Hispanic White, which is not representative of the overall population demographics.
The investigators are now designing another, larger trial that would include a more diverse participant pool. It will be aimed specifically at learning more about how and why multivitamins seem to offer a protective effect on cognition, Dr. Baker noted.
The study was funded by the National Institute on Aging of the National Institutes of Health. Dr. Baker and Dr. Carrillo report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Unexpected results from a phase 3 trial exploring the effect of multivitamins and cognition have now been published.
Originally presented last November at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) conference, this is the first large-scale, long-term randomized controlled trial to examine the effects of cocoa extract and multivitamins on global cognition. The trial’s primary focus was on cocoa extract, which earlier studies suggest may preserve cognitive function. Analyzing the effect of multivitamins was a secondary outcome.
Showing vitamins, but not cocoa, were beneficial is the exact opposite of what researchers expected. Still, the results offer an interesting new direction for future study, lead investigator Laura D. Baker, PhD, professor of gerontology and geriatric medicine at Wake Forest University, Winston-Salem, N.C., said in an interview.
“This study made us take notice of a pathway for possible cognitive protection,” Dr. Baker said. “Without this study, we would never have looked down that road.”
The full results were published online in Alzheimer’s and Dementia.
Unexpected effect
The COSMOS-Mind study is a substudy to a larger parent trial called COSMOS. It investigated the effects of cocoa extract and a standard multivitamin-mineral on cardiovascular and cancer outcomes in more than 21,000 older participants.
In COSMOS-Mind, researchers tested whether daily intake of cocoa extract vs. placebo and a multivitamin-mineral vs. placebo improved cognition in older adults.
More than 2,200 participants aged 65 and older were enrolled and followed for 3 years. They completed tests over the telephone at baseline and annually to evaluate memory and other cognitive abilities.
Results showed cocoa extract had no effect on global cognition compared with placebo (mean z-score, 0.03; P = .28). Daily multivitamin use, however, did show significant benefits on global cognition vs. placebo (mean z, 0.07, P = .007).
The beneficial effect was most pronounced in participants with a history of cardiovascular disease (no history 0.06 vs. history 0.14; P = .01).
Researchers found similar protective effects for memory and executive function.
Dr. Baker suggested one possible explanation for the positive effects of multivitamins may be the boost in micronutrients and essential minerals they provided.
“With nutrient-deficient diets plus a high prevalence of cardiovascular disease, diabetes, and other medical comorbidities that we know impact the bioavailability of these nutrients, we are possibly dealing with older adults who are at below optimum in terms of their essential micronutrients and minerals,” she said.
“Even suboptimum levels of micronutrients and essential minerals can have significant consequences for brain health,” she added.
More research needed
Intriguing as the results may be, more work is needed before the findings could affect nutritional guidance, according to Maria C. Carrillo, PhD, chief science officer for the Alzheimer’s Association.
“While the Alzheimer’s Association is encouraged by these results, we are not ready to recommend widespread use of a multivitamin supplement to reduce risk of cognitive decline in older adults,” Dr. Carrillo said in a statement.
“For now, and until there is more data, people should talk with their health care providers about the benefits and risks of all dietary supplements, including multivitamins,” she added.
Dr. Baker agreed, noting that the study was not designed to measure multivitamin use as a primary outcome. In addition, nearly 90% of the participants were non-Hispanic White, which is not representative of the overall population demographics.
The investigators are now designing another, larger trial that would include a more diverse participant pool. It will be aimed specifically at learning more about how and why multivitamins seem to offer a protective effect on cognition, Dr. Baker noted.
The study was funded by the National Institute on Aging of the National Institutes of Health. Dr. Baker and Dr. Carrillo report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Unexpected results from a phase 3 trial exploring the effect of multivitamins and cognition have now been published.
Originally presented last November at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) conference, this is the first large-scale, long-term randomized controlled trial to examine the effects of cocoa extract and multivitamins on global cognition. The trial’s primary focus was on cocoa extract, which earlier studies suggest may preserve cognitive function. Analyzing the effect of multivitamins was a secondary outcome.
Showing vitamins, but not cocoa, were beneficial is the exact opposite of what researchers expected. Still, the results offer an interesting new direction for future study, lead investigator Laura D. Baker, PhD, professor of gerontology and geriatric medicine at Wake Forest University, Winston-Salem, N.C., said in an interview.
“This study made us take notice of a pathway for possible cognitive protection,” Dr. Baker said. “Without this study, we would never have looked down that road.”
The full results were published online in Alzheimer’s and Dementia.
Unexpected effect
The COSMOS-Mind study is a substudy to a larger parent trial called COSMOS. It investigated the effects of cocoa extract and a standard multivitamin-mineral on cardiovascular and cancer outcomes in more than 21,000 older participants.
In COSMOS-Mind, researchers tested whether daily intake of cocoa extract vs. placebo and a multivitamin-mineral vs. placebo improved cognition in older adults.
More than 2,200 participants aged 65 and older were enrolled and followed for 3 years. They completed tests over the telephone at baseline and annually to evaluate memory and other cognitive abilities.
Results showed cocoa extract had no effect on global cognition compared with placebo (mean z-score, 0.03; P = .28). Daily multivitamin use, however, did show significant benefits on global cognition vs. placebo (mean z, 0.07, P = .007).
The beneficial effect was most pronounced in participants with a history of cardiovascular disease (no history 0.06 vs. history 0.14; P = .01).
Researchers found similar protective effects for memory and executive function.
Dr. Baker suggested one possible explanation for the positive effects of multivitamins may be the boost in micronutrients and essential minerals they provided.
“With nutrient-deficient diets plus a high prevalence of cardiovascular disease, diabetes, and other medical comorbidities that we know impact the bioavailability of these nutrients, we are possibly dealing with older adults who are at below optimum in terms of their essential micronutrients and minerals,” she said.
“Even suboptimum levels of micronutrients and essential minerals can have significant consequences for brain health,” she added.
More research needed
Intriguing as the results may be, more work is needed before the findings could affect nutritional guidance, according to Maria C. Carrillo, PhD, chief science officer for the Alzheimer’s Association.
“While the Alzheimer’s Association is encouraged by these results, we are not ready to recommend widespread use of a multivitamin supplement to reduce risk of cognitive decline in older adults,” Dr. Carrillo said in a statement.
“For now, and until there is more data, people should talk with their health care providers about the benefits and risks of all dietary supplements, including multivitamins,” she added.
Dr. Baker agreed, noting that the study was not designed to measure multivitamin use as a primary outcome. In addition, nearly 90% of the participants were non-Hispanic White, which is not representative of the overall population demographics.
The investigators are now designing another, larger trial that would include a more diverse participant pool. It will be aimed specifically at learning more about how and why multivitamins seem to offer a protective effect on cognition, Dr. Baker noted.
The study was funded by the National Institute on Aging of the National Institutes of Health. Dr. Baker and Dr. Carrillo report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ALZHEIMER’S AND DEMENTIA
Opioids after lung cancer surgery may up all-cause mortality risk
Patients who undergo lung cancer surgery and who receive long-term opioids for pain relief have an elevated risk of all-cause mortality at 2 years, a new study suggests. That risk was 40% higher than among patients who did not receive opioids.
“This is the first study to identify the association of new long-term opioid use with poorer long-term survival outcomes after lung cancer surgery using real-world data based on a national registration database,” said the authors, led by In-Ae Song, MD, Seoul National University Bundang Hospital, Seongnam, South Korea.
“New long-term opioid use may be associated with poor long-term survival outcomes, especially in potent opioid users,” they concluded.
Long-term opioid use might promote protumor activity secondary to immunosuppression along with migration of tumor cells and angiogenesis, the authors suggested.
The study was published online in Regional Anesthesia and Pain.
The finding comes from a study that used the South Korean National Health Insurance database as a nationwide registration data source. “All patients undergoing lung cancer surgery between 2011 and 2018 were included,” the authors noted.
In total, 54,509 patients were included in the final analysis. Six months after undergoing the procedure, 3,325 patients (6.1%) had been prescribed opioids continuously and regularly. These patients constituted the new long-term opioid user group.
This finding fits in with those from past studies that have suggested that new long-term postoperative pain is reported in 4%-12% of patients who undergo lung cancer surgeries, the authors commented.
The new study found that all-cause mortality at 2 years was significantly higher in the new long-term opioid user group than it was in the non–opioid user group (17.3% vs. 9.3%; P < .001).
Moreover, the new long-term opioid user group were at 43% higher risk of 2-year lung cancer mortality and 29% higher risk of 2-year non–lung cancer mortality.
The investigators divided the patients who had received long-term opioids into two subgroups – those who received more potent opioids (1.6%), and those who received less potent opioids (4.5%).
There was a big difference in the results for all-cause mortality.
Compared with nonopioid users, long-term use of less potent opioids was associated with a 2-year mortality risk of only 22% (P < .001), whereas the patients who used potent opioids were at a 92% increased risk of all-cause mortality.
A number of risk factors were associated with an increased rate of new long-term opioid use. These included older age, being male, length of stay in hospital, and comorbidities.
In addition, patients who were more likely to receive long-term opioids included those who had received neoadjuvant and adjuvant chemotherapy and those who had experienced preoperative anxiety disorder or insomnia disorder.
In contrast, patients who underwent video-assisted thoracoscopic surgery were less likely to receive long-term opioids, the authors noted.
The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Patients who undergo lung cancer surgery and who receive long-term opioids for pain relief have an elevated risk of all-cause mortality at 2 years, a new study suggests. That risk was 40% higher than among patients who did not receive opioids.
“This is the first study to identify the association of new long-term opioid use with poorer long-term survival outcomes after lung cancer surgery using real-world data based on a national registration database,” said the authors, led by In-Ae Song, MD, Seoul National University Bundang Hospital, Seongnam, South Korea.
“New long-term opioid use may be associated with poor long-term survival outcomes, especially in potent opioid users,” they concluded.
Long-term opioid use might promote protumor activity secondary to immunosuppression along with migration of tumor cells and angiogenesis, the authors suggested.
The study was published online in Regional Anesthesia and Pain.
The finding comes from a study that used the South Korean National Health Insurance database as a nationwide registration data source. “All patients undergoing lung cancer surgery between 2011 and 2018 were included,” the authors noted.
In total, 54,509 patients were included in the final analysis. Six months after undergoing the procedure, 3,325 patients (6.1%) had been prescribed opioids continuously and regularly. These patients constituted the new long-term opioid user group.
This finding fits in with those from past studies that have suggested that new long-term postoperative pain is reported in 4%-12% of patients who undergo lung cancer surgeries, the authors commented.
The new study found that all-cause mortality at 2 years was significantly higher in the new long-term opioid user group than it was in the non–opioid user group (17.3% vs. 9.3%; P < .001).
Moreover, the new long-term opioid user group were at 43% higher risk of 2-year lung cancer mortality and 29% higher risk of 2-year non–lung cancer mortality.
The investigators divided the patients who had received long-term opioids into two subgroups – those who received more potent opioids (1.6%), and those who received less potent opioids (4.5%).
There was a big difference in the results for all-cause mortality.
Compared with nonopioid users, long-term use of less potent opioids was associated with a 2-year mortality risk of only 22% (P < .001), whereas the patients who used potent opioids were at a 92% increased risk of all-cause mortality.
A number of risk factors were associated with an increased rate of new long-term opioid use. These included older age, being male, length of stay in hospital, and comorbidities.
In addition, patients who were more likely to receive long-term opioids included those who had received neoadjuvant and adjuvant chemotherapy and those who had experienced preoperative anxiety disorder or insomnia disorder.
In contrast, patients who underwent video-assisted thoracoscopic surgery were less likely to receive long-term opioids, the authors noted.
The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Patients who undergo lung cancer surgery and who receive long-term opioids for pain relief have an elevated risk of all-cause mortality at 2 years, a new study suggests. That risk was 40% higher than among patients who did not receive opioids.
“This is the first study to identify the association of new long-term opioid use with poorer long-term survival outcomes after lung cancer surgery using real-world data based on a national registration database,” said the authors, led by In-Ae Song, MD, Seoul National University Bundang Hospital, Seongnam, South Korea.
“New long-term opioid use may be associated with poor long-term survival outcomes, especially in potent opioid users,” they concluded.
Long-term opioid use might promote protumor activity secondary to immunosuppression along with migration of tumor cells and angiogenesis, the authors suggested.
The study was published online in Regional Anesthesia and Pain.
The finding comes from a study that used the South Korean National Health Insurance database as a nationwide registration data source. “All patients undergoing lung cancer surgery between 2011 and 2018 were included,” the authors noted.
In total, 54,509 patients were included in the final analysis. Six months after undergoing the procedure, 3,325 patients (6.1%) had been prescribed opioids continuously and regularly. These patients constituted the new long-term opioid user group.
This finding fits in with those from past studies that have suggested that new long-term postoperative pain is reported in 4%-12% of patients who undergo lung cancer surgeries, the authors commented.
The new study found that all-cause mortality at 2 years was significantly higher in the new long-term opioid user group than it was in the non–opioid user group (17.3% vs. 9.3%; P < .001).
Moreover, the new long-term opioid user group were at 43% higher risk of 2-year lung cancer mortality and 29% higher risk of 2-year non–lung cancer mortality.
The investigators divided the patients who had received long-term opioids into two subgroups – those who received more potent opioids (1.6%), and those who received less potent opioids (4.5%).
There was a big difference in the results for all-cause mortality.
Compared with nonopioid users, long-term use of less potent opioids was associated with a 2-year mortality risk of only 22% (P < .001), whereas the patients who used potent opioids were at a 92% increased risk of all-cause mortality.
A number of risk factors were associated with an increased rate of new long-term opioid use. These included older age, being male, length of stay in hospital, and comorbidities.
In addition, patients who were more likely to receive long-term opioids included those who had received neoadjuvant and adjuvant chemotherapy and those who had experienced preoperative anxiety disorder or insomnia disorder.
In contrast, patients who underwent video-assisted thoracoscopic surgery were less likely to receive long-term opioids, the authors noted.
The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM REGIONAL ANESTHESIA AND PAIN
Improving Bone Health in Patients With Advanced Prostate Cancer With the Use of Algorithm-Based Clinical Practice Tool at Salt Lake City VA
Background
The bone health of patients with locally advanced and metastatic prostate cancer is at risk both from treatment-related loss of bone density and skeletal-related events from metastasis to bones. Evidence-based guidelines recommend the use of denosumab or zoledronic acid at bone metastasis-indicated dosages in the setting of castration-resistant prostate cancer with bone metastases, and at the osteoporosis-indicated dosages in the hormone-sensitive setting in patients with a significant risk of fragility fracture. For the concerns of jaw osteonecrosis, a dental evaluation is recommended before starting bone modifying agents. The literature review suggests that there is a limited evidence-based practice for bone health with prostate cancer in the real world. Both underdosing and overdosing on bone remodeling therapies place additional risk on bone health. An incomplete dental workup before starting bone modifying agents increases the risk of osteonecrosis of the jaw.
Methods
To minimize the deviation from evidencebased guidelines at VA Salt Lake City Health Care, and to provide appropriate bone health care to our patients, we created an algorithm-based clinical practice tool. This order set was incorporated into the electronic medical record system to be used while ordering a bone remodeling agent for prostate cancer. The tool prompts the clinicians to follow the appropriate algorithm in a stepwise manner to ensure a pretreatment dental evaluation and use of the correct dosage of drugs.
Results
We analyzed the data from Sept 2019 to April 2022 following the incorporation of this tool. 0/35 (0%) patients were placed on inappropriate bone modifying agent dosing and dental health was addressed on every patient before initiating treatment. We noted a significant change in the clinician’s practice while prescribing denosumab/zoledronate before and after implementation of this tool (24/41 vs 0/35, P < .00001); and an improvement in pretreatment dental checkups before and after implementation of the tool was noted to be 12/41 vs 0/35 (P < .00001).
Conclusions
We found that incorporating an evidence-based algorithm in the order set while prescribing bone remodeling agents led to a significant improvement in our institutional clinical practice to provide high-quality evidence-based care to our patients with prostate cancer.
Background
The bone health of patients with locally advanced and metastatic prostate cancer is at risk both from treatment-related loss of bone density and skeletal-related events from metastasis to bones. Evidence-based guidelines recommend the use of denosumab or zoledronic acid at bone metastasis-indicated dosages in the setting of castration-resistant prostate cancer with bone metastases, and at the osteoporosis-indicated dosages in the hormone-sensitive setting in patients with a significant risk of fragility fracture. For the concerns of jaw osteonecrosis, a dental evaluation is recommended before starting bone modifying agents. The literature review suggests that there is a limited evidence-based practice for bone health with prostate cancer in the real world. Both underdosing and overdosing on bone remodeling therapies place additional risk on bone health. An incomplete dental workup before starting bone modifying agents increases the risk of osteonecrosis of the jaw.
Methods
To minimize the deviation from evidencebased guidelines at VA Salt Lake City Health Care, and to provide appropriate bone health care to our patients, we created an algorithm-based clinical practice tool. This order set was incorporated into the electronic medical record system to be used while ordering a bone remodeling agent for prostate cancer. The tool prompts the clinicians to follow the appropriate algorithm in a stepwise manner to ensure a pretreatment dental evaluation and use of the correct dosage of drugs.
Results
We analyzed the data from Sept 2019 to April 2022 following the incorporation of this tool. 0/35 (0%) patients were placed on inappropriate bone modifying agent dosing and dental health was addressed on every patient before initiating treatment. We noted a significant change in the clinician’s practice while prescribing denosumab/zoledronate before and after implementation of this tool (24/41 vs 0/35, P < .00001); and an improvement in pretreatment dental checkups before and after implementation of the tool was noted to be 12/41 vs 0/35 (P < .00001).
Conclusions
We found that incorporating an evidence-based algorithm in the order set while prescribing bone remodeling agents led to a significant improvement in our institutional clinical practice to provide high-quality evidence-based care to our patients with prostate cancer.
Background
The bone health of patients with locally advanced and metastatic prostate cancer is at risk both from treatment-related loss of bone density and skeletal-related events from metastasis to bones. Evidence-based guidelines recommend the use of denosumab or zoledronic acid at bone metastasis-indicated dosages in the setting of castration-resistant prostate cancer with bone metastases, and at the osteoporosis-indicated dosages in the hormone-sensitive setting in patients with a significant risk of fragility fracture. For the concerns of jaw osteonecrosis, a dental evaluation is recommended before starting bone modifying agents. The literature review suggests that there is a limited evidence-based practice for bone health with prostate cancer in the real world. Both underdosing and overdosing on bone remodeling therapies place additional risk on bone health. An incomplete dental workup before starting bone modifying agents increases the risk of osteonecrosis of the jaw.
Methods
To minimize the deviation from evidencebased guidelines at VA Salt Lake City Health Care, and to provide appropriate bone health care to our patients, we created an algorithm-based clinical practice tool. This order set was incorporated into the electronic medical record system to be used while ordering a bone remodeling agent for prostate cancer. The tool prompts the clinicians to follow the appropriate algorithm in a stepwise manner to ensure a pretreatment dental evaluation and use of the correct dosage of drugs.
Results
We analyzed the data from Sept 2019 to April 2022 following the incorporation of this tool. 0/35 (0%) patients were placed on inappropriate bone modifying agent dosing and dental health was addressed on every patient before initiating treatment. We noted a significant change in the clinician’s practice while prescribing denosumab/zoledronate before and after implementation of this tool (24/41 vs 0/35, P < .00001); and an improvement in pretreatment dental checkups before and after implementation of the tool was noted to be 12/41 vs 0/35 (P < .00001).
Conclusions
We found that incorporating an evidence-based algorithm in the order set while prescribing bone remodeling agents led to a significant improvement in our institutional clinical practice to provide high-quality evidence-based care to our patients with prostate cancer.
Post Pandemic Return to Colorectal Cancer Screening
Purpose/Background
Colorectal cancer (CRC) screening was significantly curtailed due to the COVID-19 pandemic and Hines VA Medical Center in Illinois performed 50% fewer screening colonoscopies in 2020 compared to 2019 (pre-pandemic). This quality study aimed to increase use of fecal immunochemical tests (FIT) as an alternative screening method while in-person screening was limited. The primary goal was to return to pre-pandemic rates of screening (colonoscopy + FIT) and the secondary goal was to increase monthly screenings by 10% to address the backlog of patients not screened early in the pandemic.
Methods/Data Analysis
Using Plan-Do-StudyAct (PDSA) quality improvement methodology, a multidisciplinary team led by Primary Care, Gastroenterology and Laboratory/Pathology services, standardized processes for dissemination and processing of FIT tests. The first PDSA cycle implemented utilization of Colorectal Cancer Screening & Surveillance Clinical Reports (CRCS/S) to identify average-risk patients due or overdue for screening, devised plain language patient instructions for FIT-based testing, and formalized a mechanism for tracking FIT test kits.
Results
Baseline number of CRC screenings in 2019 was 2,808 (750 colonoscopy + 2,058 FIT). After the first PDSA cycle, CRC screenings were recorded during the 12-month period from April 2021 to March 2022. Colonoscopy + FIT increased to 3,558, largely due to an increase in completed FIT tests (362 colonoscopy + 3,196 FIT tests). While the number of screening colonoscopies was 52% lower compared to 2019, the number of patients screened with FIT increased by 55% after the intervention. Colonoscopy + FIT in the 12 month period starting in April of 2021 exceeded that of 2019, supporting the fact that stoolbased FIT testing was a feasible approach to screening average risk patients while in-person screening activities were restricted.
Conclusions
This quality improvement study met the primary goal of returning to pre-pandemic rates of colonoscopy + FIT and the secondary goal of increasing average number of monthly screenings by 10% to address the backlog of patients not screened early in the pandemic. Interventions directed at optimizing the FIT test process were associated with an increase in completed FIT tests. Planned PDSA cycle two will implement a mailed FIT Outreach pilot to reach additional patients for CRC screening.
Purpose/Background
Colorectal cancer (CRC) screening was significantly curtailed due to the COVID-19 pandemic and Hines VA Medical Center in Illinois performed 50% fewer screening colonoscopies in 2020 compared to 2019 (pre-pandemic). This quality study aimed to increase use of fecal immunochemical tests (FIT) as an alternative screening method while in-person screening was limited. The primary goal was to return to pre-pandemic rates of screening (colonoscopy + FIT) and the secondary goal was to increase monthly screenings by 10% to address the backlog of patients not screened early in the pandemic.
Methods/Data Analysis
Using Plan-Do-StudyAct (PDSA) quality improvement methodology, a multidisciplinary team led by Primary Care, Gastroenterology and Laboratory/Pathology services, standardized processes for dissemination and processing of FIT tests. The first PDSA cycle implemented utilization of Colorectal Cancer Screening & Surveillance Clinical Reports (CRCS/S) to identify average-risk patients due or overdue for screening, devised plain language patient instructions for FIT-based testing, and formalized a mechanism for tracking FIT test kits.
Results
Baseline number of CRC screenings in 2019 was 2,808 (750 colonoscopy + 2,058 FIT). After the first PDSA cycle, CRC screenings were recorded during the 12-month period from April 2021 to March 2022. Colonoscopy + FIT increased to 3,558, largely due to an increase in completed FIT tests (362 colonoscopy + 3,196 FIT tests). While the number of screening colonoscopies was 52% lower compared to 2019, the number of patients screened with FIT increased by 55% after the intervention. Colonoscopy + FIT in the 12 month period starting in April of 2021 exceeded that of 2019, supporting the fact that stoolbased FIT testing was a feasible approach to screening average risk patients while in-person screening activities were restricted.
Conclusions
This quality improvement study met the primary goal of returning to pre-pandemic rates of colonoscopy + FIT and the secondary goal of increasing average number of monthly screenings by 10% to address the backlog of patients not screened early in the pandemic. Interventions directed at optimizing the FIT test process were associated with an increase in completed FIT tests. Planned PDSA cycle two will implement a mailed FIT Outreach pilot to reach additional patients for CRC screening.
Purpose/Background
Colorectal cancer (CRC) screening was significantly curtailed due to the COVID-19 pandemic and Hines VA Medical Center in Illinois performed 50% fewer screening colonoscopies in 2020 compared to 2019 (pre-pandemic). This quality study aimed to increase use of fecal immunochemical tests (FIT) as an alternative screening method while in-person screening was limited. The primary goal was to return to pre-pandemic rates of screening (colonoscopy + FIT) and the secondary goal was to increase monthly screenings by 10% to address the backlog of patients not screened early in the pandemic.
Methods/Data Analysis
Using Plan-Do-StudyAct (PDSA) quality improvement methodology, a multidisciplinary team led by Primary Care, Gastroenterology and Laboratory/Pathology services, standardized processes for dissemination and processing of FIT tests. The first PDSA cycle implemented utilization of Colorectal Cancer Screening & Surveillance Clinical Reports (CRCS/S) to identify average-risk patients due or overdue for screening, devised plain language patient instructions for FIT-based testing, and formalized a mechanism for tracking FIT test kits.
Results
Baseline number of CRC screenings in 2019 was 2,808 (750 colonoscopy + 2,058 FIT). After the first PDSA cycle, CRC screenings were recorded during the 12-month period from April 2021 to March 2022. Colonoscopy + FIT increased to 3,558, largely due to an increase in completed FIT tests (362 colonoscopy + 3,196 FIT tests). While the number of screening colonoscopies was 52% lower compared to 2019, the number of patients screened with FIT increased by 55% after the intervention. Colonoscopy + FIT in the 12 month period starting in April of 2021 exceeded that of 2019, supporting the fact that stoolbased FIT testing was a feasible approach to screening average risk patients while in-person screening activities were restricted.
Conclusions
This quality improvement study met the primary goal of returning to pre-pandemic rates of colonoscopy + FIT and the secondary goal of increasing average number of monthly screenings by 10% to address the backlog of patients not screened early in the pandemic. Interventions directed at optimizing the FIT test process were associated with an increase in completed FIT tests. Planned PDSA cycle two will implement a mailed FIT Outreach pilot to reach additional patients for CRC screening.
My Life, My Story: Patient Experience Evaluation in Palliative Care
Purpose
To assess palliative care patients’ experience completing the My Life, My Story (MLMS) program.
Background
MLMS was developed in 2013 at William S. Middleton Memorial Veterans Hospital. Previous research on MLMS shows benefits for both providers and patients. The program involves working with veterans to write their personal narrative story. VA Connecticut Palliative Care Team has applied the MLMS program in their clinical care with veterans.
Methods
Veterans were administered a 5-point Likert scale questionnaire 2 weeks following completion of the MLMS program. Participants were asked 1 open-ended question assessing effects of MLMS participation, and information on dissemination of their story. Demographic data was collected via chart review.
Data Analysis
Descriptive statistics were run to evaluate participant’s responses to Likert scale items. Thematic analysis was used to assess participants’ qualitative responses.
Results
Participants (N = 19) were largely male (n = 18, 94.7%), White (n = 18, 94.7%), not Hispanic or Latino (n = 19, 100%), with a cancer diagnosis (n = 14, 73.7%). Most participants agreed or strongly agreed that completing MLMS was a good use of time with their provider (n = 19, 100%), would recommend MLMS to other veterans (n = 19, 100%), felt more understood by providers (n = 13, 68.4%), felt more connected to family/friends (n = 16, 84.2%), provided sense of meaning/purpose (n = 15, 78.9%), and felt the process of completing MLMS was easy (n = 17, 89.5%). Veterans shared their story with family (n = 13), friends (n = 6), providers (n = 3), or did not share their story with others (n = 4). The following 7 major themes emerged when asking participants how the process of creating their life story affected them: reflection on life, overall positive experience, cathartic to tell story, foster sense of pride, family legacy, increased provider insight, and negative feedback.
Conclusions/Implications
Veterans had an overall positive experience participating in the MLMS program in palliative care.
MLMS is a low budget, low-risk intervention with positive outcomes for implementation into oncology and palliative care programs across VA healthcare centers.
Purpose
To assess palliative care patients’ experience completing the My Life, My Story (MLMS) program.
Background
MLMS was developed in 2013 at William S. Middleton Memorial Veterans Hospital. Previous research on MLMS shows benefits for both providers and patients. The program involves working with veterans to write their personal narrative story. VA Connecticut Palliative Care Team has applied the MLMS program in their clinical care with veterans.
Methods
Veterans were administered a 5-point Likert scale questionnaire 2 weeks following completion of the MLMS program. Participants were asked 1 open-ended question assessing effects of MLMS participation, and information on dissemination of their story. Demographic data was collected via chart review.
Data Analysis
Descriptive statistics were run to evaluate participant’s responses to Likert scale items. Thematic analysis was used to assess participants’ qualitative responses.
Results
Participants (N = 19) were largely male (n = 18, 94.7%), White (n = 18, 94.7%), not Hispanic or Latino (n = 19, 100%), with a cancer diagnosis (n = 14, 73.7%). Most participants agreed or strongly agreed that completing MLMS was a good use of time with their provider (n = 19, 100%), would recommend MLMS to other veterans (n = 19, 100%), felt more understood by providers (n = 13, 68.4%), felt more connected to family/friends (n = 16, 84.2%), provided sense of meaning/purpose (n = 15, 78.9%), and felt the process of completing MLMS was easy (n = 17, 89.5%). Veterans shared their story with family (n = 13), friends (n = 6), providers (n = 3), or did not share their story with others (n = 4). The following 7 major themes emerged when asking participants how the process of creating their life story affected them: reflection on life, overall positive experience, cathartic to tell story, foster sense of pride, family legacy, increased provider insight, and negative feedback.
Conclusions/Implications
Veterans had an overall positive experience participating in the MLMS program in palliative care.
MLMS is a low budget, low-risk intervention with positive outcomes for implementation into oncology and palliative care programs across VA healthcare centers.
Purpose
To assess palliative care patients’ experience completing the My Life, My Story (MLMS) program.
Background
MLMS was developed in 2013 at William S. Middleton Memorial Veterans Hospital. Previous research on MLMS shows benefits for both providers and patients. The program involves working with veterans to write their personal narrative story. VA Connecticut Palliative Care Team has applied the MLMS program in their clinical care with veterans.
Methods
Veterans were administered a 5-point Likert scale questionnaire 2 weeks following completion of the MLMS program. Participants were asked 1 open-ended question assessing effects of MLMS participation, and information on dissemination of their story. Demographic data was collected via chart review.
Data Analysis
Descriptive statistics were run to evaluate participant’s responses to Likert scale items. Thematic analysis was used to assess participants’ qualitative responses.
Results
Participants (N = 19) were largely male (n = 18, 94.7%), White (n = 18, 94.7%), not Hispanic or Latino (n = 19, 100%), with a cancer diagnosis (n = 14, 73.7%). Most participants agreed or strongly agreed that completing MLMS was a good use of time with their provider (n = 19, 100%), would recommend MLMS to other veterans (n = 19, 100%), felt more understood by providers (n = 13, 68.4%), felt more connected to family/friends (n = 16, 84.2%), provided sense of meaning/purpose (n = 15, 78.9%), and felt the process of completing MLMS was easy (n = 17, 89.5%). Veterans shared their story with family (n = 13), friends (n = 6), providers (n = 3), or did not share their story with others (n = 4). The following 7 major themes emerged when asking participants how the process of creating their life story affected them: reflection on life, overall positive experience, cathartic to tell story, foster sense of pride, family legacy, increased provider insight, and negative feedback.
Conclusions/Implications
Veterans had an overall positive experience participating in the MLMS program in palliative care.
MLMS is a low budget, low-risk intervention with positive outcomes for implementation into oncology and palliative care programs across VA healthcare centers.