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Analysis suggests CV benefits for some antioxidant supplements
Other antioxidant supplements that showed some evidence of reducing cardiovascular risk were omega-6 fatty acids, L-arginine, L-citrulline, magnesium, zinc, alpha-lipoic acid, melatonin, catechin, curcumin, flavanol, genistein, and quercetin.
No effect was seen with vitamin C, vitamin D, vitamin E, or selenium, and beta-carotene supplementation was linked to an increase in all-cause mortality in the analysis.
The study is published in the Journal of the American College of Cardiology and was also published online.
“Our systematic assessment and quantification of multiple differential effects of a wide variety of micronutrients and phytochemicals on cardiometabolic health indicate that an optimal nutritional strategy to promote cardiometabolic health will likely involve personalized combinations of these nutrients,” the authors, led by Peng An, PhD, China Agricultural University, Beijing, conclude.
“Identifying the optimal mixture of micronutrients is important, as not all are beneficial, and some may even have harmful effects,” senior author Simin Liu, MD, professor of epidemiology and medicine at Brown University, Providence, R.I., said in an American College of Cardiology press release.
“The micronutrients identified require further validation in large, high-quality interventional trials to establish clinical efficacy to determine their long-term balance of risks and benefits,” the authors add.
Experts cautious
Experts in the field of cardiovascular risk and preventative medicine have urged caution in interpreting these results.
JoAnn Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital, Boston, told this news organization that she has concerns that some of the results in the meta-analysis may be inflated by publication bias and some are chance findings that haven’t been well replicated.
“Although this meta-analysis of micronutrients and cardiometabolic health was based on randomized clinical trials, the quality of randomized trials on this subject varies widely,” she noted.
“The study is informative, but the conclusions are only as good as the quality of the evidence. Some of the trials are limited by short duration, and included trials have a wide range of quality, dosing, inclusion criteria, imperfect blinding, and few of them focus on hard clinical events,” Dr. Manson said. “Also, with trials of this nature, the potential for publication bias warrants consideration, because many of the smaller trials with unfavorable or neutral results may remain unpublished or not even be submitted for publication.”
However, she added, “despite these limitations, this is an important contribution to the literature on micronutrients and health – and goes a long way in separating the wheat from the chaff.”
Steve Nissen, MD, chief academic officer of the Heart Vascular and Thoracic Institute at the Cleveland Clinic, was more critical of the meta-analysis.
“This study does not make sense. Some of the ‘micronutrients’ in this meta-analysis have undergone thorough testing in large randomized clinical trials that showed different results. I am skeptical whether any of the purported benefits of these supplements would be confirmed in a high-quality randomized controlled trial,” he said.
Dr. Nissen added that many of the included studies are low in quality. “I must quote [renowned cardiologist, Dr.] Franz Messerli: ‘A meta-analysis is like making bouillabaisse. ... One rotten fish can spoil the broth.’ This type of analysis does not override high-quality large, randomized trials.”
In the JACC paper, the study investigators note that the American Heart Association now recommends dietary patterns, including the Mediterranean diet and DASH (the Dietary Approach to Stop Hypertension), as preventive or treatment approaches for cardiovascular disease. A common feature of these dietary patterns is that they are low in saturated fat and sodium and rich in micronutrients such as phytochemicals, unsaturated fatty acids, antioxidant vitamins, and minerals.
“To personalize cardiometabolic preventive and therapeutic dietary practices, it is of critical importance to have a comprehensive and in-depth understanding of the balance of benefits and risks associated with constituent micronutrients in diverse dietary patterns,” they note.
They therefore conducted the current systematic review and meta-analyses of all available randomized controlled trials investigating the effect of micronutrients with antioxidant properties on cardiovascular risk factors and events in diverse populations.
The meta-analysis included a total of 884 randomized trials evaluating 27 types of micronutrients among 883,627 participants.
Results showed that supplementation with n-3 fatty acids, n-6 fatty acids, L-arginine, L-citrulline, folic acid, magnesium, zinc, alpha-lipoic acid, coenzyme Q10, melatonin, catechin, curcumin, flavanol, genistein, and quercetin had “moderate-to high-quality evidence” for reducing cardiovascular risk factors.
Specifically, n-3 fatty acid supplementation was linked to reduced rates of cardiovascular mortality (relative risk, 0.93), myocardial infarction (RR, 0.85), and coronary heart disease events (RR, 0.86). Folic acid supplementation was linked to a decreased stroke risk (RR, 0.84) and coenzyme Q10 was associated with a lower rate of all-cause mortality (RR, 0.68).
“The current study represents the first attempt in providing a comprehensive and most up-to-date evidence map that systematically assessed the quality and quantity of all randomized trials linking the effects of a wide variety of micronutrients on cardiovascular risk factors,” the authors say.
“The comprehensive evidence map presented here highlights the importance of micronutrient diversity and the balance of benefits and risks in the design of whole food–based dietary patterns to promote cardiometabolic health, which may require cultural adaptations to apply globally,” they conclude.
Commenting on some of the specific beneficial findings, Dr. Manson said: “I do believe that the marine omega-3s confer heart benefits, but results are not consistent and vary by dose and formulation.”
However, she pointed out that, regarding folic acid, a previous meta-analysis including eight large randomized trials in more than 37,000 participants found no reduction in coronary events, stroke, or major cardiovascular events with folic acid supplementation, compared with placebo, “so the reported stroke benefit would need further confirmation.”
In an accompanying editorial, Juan Gormaz, PhD, University of Chile, and Rodrigo Carrasco, MD, Chilean Society of Cardiology and Cardiovascular Surgery, both in Santiago, state: “Given that the compounds with more pleiotropic properties produced the better outcomes, the antioxidant paradigm on cardiovascular prevention can be challenged. For example, inasmuch as n-3 fatty acids have antiplatelet and anti-inflammatory properties, they are too complex to enable attribution of the observed benefits solely to their antioxidant capacity.”
The editorialists note that from a research point of view, “although the current information opens interesting perspectives for future consolidation of some antioxidants in preventive cardiology, there is still a long way to go in terms of generating evidence.”
They add that the challenge now for some compounds is to begin establishing consensus in definitions of dose and combinations, as well as continue strengthening the evidence of effectiveness.
“Regarding routine clinical practice, these results begin to open spaces for the integration of new tools into the therapeutic arsenal aimed at cardiovascular prevention in selected populations, which could be easily accessible and, with specific exceptions, would present a low frequency of adverse effects,” they conclude.
This work was partly supported by the United States’ Fulbright Program and by the Beijing Advanced Innovation Center for Food Nutrition and Human Health, the National Natural Science Foundation of China, the Chinese Universities Scientific Fund, and the Beijing Municipal Natural Science Foundation.
Dr. Liu has received honoraria for scientific presentations or reviews at Johns Hopkins University, Fred Hutchinson Cancer Center, Harvard University, University of Buffalo, Guangdong General Hospital, Fuwai Hospital, Chinese Academy of Medical Sciences, and the National Institutes of Health; he is a member of the Data Safety and Monitoring Board for several trials, including the SELECT (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity) trial sponsored by Novo Nordisk and a trial of pulmonary hypertension in diabetes patients sponsored by Massachusetts General Hospital; he has received royalties from UpToDate and has received an honorarium from the American Society for Nutrition for his duties as Associate Editor. Co-author Jeffrey Mechanick, MD, has received honoraria from Abbott Nutrition for lectures and serves on the advisory boards of Aveta.Life, L-Nutra, and Twin Health. The other authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Other antioxidant supplements that showed some evidence of reducing cardiovascular risk were omega-6 fatty acids, L-arginine, L-citrulline, magnesium, zinc, alpha-lipoic acid, melatonin, catechin, curcumin, flavanol, genistein, and quercetin.
No effect was seen with vitamin C, vitamin D, vitamin E, or selenium, and beta-carotene supplementation was linked to an increase in all-cause mortality in the analysis.
The study is published in the Journal of the American College of Cardiology and was also published online.
“Our systematic assessment and quantification of multiple differential effects of a wide variety of micronutrients and phytochemicals on cardiometabolic health indicate that an optimal nutritional strategy to promote cardiometabolic health will likely involve personalized combinations of these nutrients,” the authors, led by Peng An, PhD, China Agricultural University, Beijing, conclude.
“Identifying the optimal mixture of micronutrients is important, as not all are beneficial, and some may even have harmful effects,” senior author Simin Liu, MD, professor of epidemiology and medicine at Brown University, Providence, R.I., said in an American College of Cardiology press release.
“The micronutrients identified require further validation in large, high-quality interventional trials to establish clinical efficacy to determine their long-term balance of risks and benefits,” the authors add.
Experts cautious
Experts in the field of cardiovascular risk and preventative medicine have urged caution in interpreting these results.
JoAnn Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital, Boston, told this news organization that she has concerns that some of the results in the meta-analysis may be inflated by publication bias and some are chance findings that haven’t been well replicated.
“Although this meta-analysis of micronutrients and cardiometabolic health was based on randomized clinical trials, the quality of randomized trials on this subject varies widely,” she noted.
“The study is informative, but the conclusions are only as good as the quality of the evidence. Some of the trials are limited by short duration, and included trials have a wide range of quality, dosing, inclusion criteria, imperfect blinding, and few of them focus on hard clinical events,” Dr. Manson said. “Also, with trials of this nature, the potential for publication bias warrants consideration, because many of the smaller trials with unfavorable or neutral results may remain unpublished or not even be submitted for publication.”
However, she added, “despite these limitations, this is an important contribution to the literature on micronutrients and health – and goes a long way in separating the wheat from the chaff.”
Steve Nissen, MD, chief academic officer of the Heart Vascular and Thoracic Institute at the Cleveland Clinic, was more critical of the meta-analysis.
“This study does not make sense. Some of the ‘micronutrients’ in this meta-analysis have undergone thorough testing in large randomized clinical trials that showed different results. I am skeptical whether any of the purported benefits of these supplements would be confirmed in a high-quality randomized controlled trial,” he said.
Dr. Nissen added that many of the included studies are low in quality. “I must quote [renowned cardiologist, Dr.] Franz Messerli: ‘A meta-analysis is like making bouillabaisse. ... One rotten fish can spoil the broth.’ This type of analysis does not override high-quality large, randomized trials.”
In the JACC paper, the study investigators note that the American Heart Association now recommends dietary patterns, including the Mediterranean diet and DASH (the Dietary Approach to Stop Hypertension), as preventive or treatment approaches for cardiovascular disease. A common feature of these dietary patterns is that they are low in saturated fat and sodium and rich in micronutrients such as phytochemicals, unsaturated fatty acids, antioxidant vitamins, and minerals.
“To personalize cardiometabolic preventive and therapeutic dietary practices, it is of critical importance to have a comprehensive and in-depth understanding of the balance of benefits and risks associated with constituent micronutrients in diverse dietary patterns,” they note.
They therefore conducted the current systematic review and meta-analyses of all available randomized controlled trials investigating the effect of micronutrients with antioxidant properties on cardiovascular risk factors and events in diverse populations.
The meta-analysis included a total of 884 randomized trials evaluating 27 types of micronutrients among 883,627 participants.
Results showed that supplementation with n-3 fatty acids, n-6 fatty acids, L-arginine, L-citrulline, folic acid, magnesium, zinc, alpha-lipoic acid, coenzyme Q10, melatonin, catechin, curcumin, flavanol, genistein, and quercetin had “moderate-to high-quality evidence” for reducing cardiovascular risk factors.
Specifically, n-3 fatty acid supplementation was linked to reduced rates of cardiovascular mortality (relative risk, 0.93), myocardial infarction (RR, 0.85), and coronary heart disease events (RR, 0.86). Folic acid supplementation was linked to a decreased stroke risk (RR, 0.84) and coenzyme Q10 was associated with a lower rate of all-cause mortality (RR, 0.68).
“The current study represents the first attempt in providing a comprehensive and most up-to-date evidence map that systematically assessed the quality and quantity of all randomized trials linking the effects of a wide variety of micronutrients on cardiovascular risk factors,” the authors say.
“The comprehensive evidence map presented here highlights the importance of micronutrient diversity and the balance of benefits and risks in the design of whole food–based dietary patterns to promote cardiometabolic health, which may require cultural adaptations to apply globally,” they conclude.
Commenting on some of the specific beneficial findings, Dr. Manson said: “I do believe that the marine omega-3s confer heart benefits, but results are not consistent and vary by dose and formulation.”
However, she pointed out that, regarding folic acid, a previous meta-analysis including eight large randomized trials in more than 37,000 participants found no reduction in coronary events, stroke, or major cardiovascular events with folic acid supplementation, compared with placebo, “so the reported stroke benefit would need further confirmation.”
In an accompanying editorial, Juan Gormaz, PhD, University of Chile, and Rodrigo Carrasco, MD, Chilean Society of Cardiology and Cardiovascular Surgery, both in Santiago, state: “Given that the compounds with more pleiotropic properties produced the better outcomes, the antioxidant paradigm on cardiovascular prevention can be challenged. For example, inasmuch as n-3 fatty acids have antiplatelet and anti-inflammatory properties, they are too complex to enable attribution of the observed benefits solely to their antioxidant capacity.”
The editorialists note that from a research point of view, “although the current information opens interesting perspectives for future consolidation of some antioxidants in preventive cardiology, there is still a long way to go in terms of generating evidence.”
They add that the challenge now for some compounds is to begin establishing consensus in definitions of dose and combinations, as well as continue strengthening the evidence of effectiveness.
“Regarding routine clinical practice, these results begin to open spaces for the integration of new tools into the therapeutic arsenal aimed at cardiovascular prevention in selected populations, which could be easily accessible and, with specific exceptions, would present a low frequency of adverse effects,” they conclude.
This work was partly supported by the United States’ Fulbright Program and by the Beijing Advanced Innovation Center for Food Nutrition and Human Health, the National Natural Science Foundation of China, the Chinese Universities Scientific Fund, and the Beijing Municipal Natural Science Foundation.
Dr. Liu has received honoraria for scientific presentations or reviews at Johns Hopkins University, Fred Hutchinson Cancer Center, Harvard University, University of Buffalo, Guangdong General Hospital, Fuwai Hospital, Chinese Academy of Medical Sciences, and the National Institutes of Health; he is a member of the Data Safety and Monitoring Board for several trials, including the SELECT (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity) trial sponsored by Novo Nordisk and a trial of pulmonary hypertension in diabetes patients sponsored by Massachusetts General Hospital; he has received royalties from UpToDate and has received an honorarium from the American Society for Nutrition for his duties as Associate Editor. Co-author Jeffrey Mechanick, MD, has received honoraria from Abbott Nutrition for lectures and serves on the advisory boards of Aveta.Life, L-Nutra, and Twin Health. The other authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Other antioxidant supplements that showed some evidence of reducing cardiovascular risk were omega-6 fatty acids, L-arginine, L-citrulline, magnesium, zinc, alpha-lipoic acid, melatonin, catechin, curcumin, flavanol, genistein, and quercetin.
No effect was seen with vitamin C, vitamin D, vitamin E, or selenium, and beta-carotene supplementation was linked to an increase in all-cause mortality in the analysis.
The study is published in the Journal of the American College of Cardiology and was also published online.
“Our systematic assessment and quantification of multiple differential effects of a wide variety of micronutrients and phytochemicals on cardiometabolic health indicate that an optimal nutritional strategy to promote cardiometabolic health will likely involve personalized combinations of these nutrients,” the authors, led by Peng An, PhD, China Agricultural University, Beijing, conclude.
“Identifying the optimal mixture of micronutrients is important, as not all are beneficial, and some may even have harmful effects,” senior author Simin Liu, MD, professor of epidemiology and medicine at Brown University, Providence, R.I., said in an American College of Cardiology press release.
“The micronutrients identified require further validation in large, high-quality interventional trials to establish clinical efficacy to determine their long-term balance of risks and benefits,” the authors add.
Experts cautious
Experts in the field of cardiovascular risk and preventative medicine have urged caution in interpreting these results.
JoAnn Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital, Boston, told this news organization that she has concerns that some of the results in the meta-analysis may be inflated by publication bias and some are chance findings that haven’t been well replicated.
“Although this meta-analysis of micronutrients and cardiometabolic health was based on randomized clinical trials, the quality of randomized trials on this subject varies widely,” she noted.
“The study is informative, but the conclusions are only as good as the quality of the evidence. Some of the trials are limited by short duration, and included trials have a wide range of quality, dosing, inclusion criteria, imperfect blinding, and few of them focus on hard clinical events,” Dr. Manson said. “Also, with trials of this nature, the potential for publication bias warrants consideration, because many of the smaller trials with unfavorable or neutral results may remain unpublished or not even be submitted for publication.”
However, she added, “despite these limitations, this is an important contribution to the literature on micronutrients and health – and goes a long way in separating the wheat from the chaff.”
Steve Nissen, MD, chief academic officer of the Heart Vascular and Thoracic Institute at the Cleveland Clinic, was more critical of the meta-analysis.
“This study does not make sense. Some of the ‘micronutrients’ in this meta-analysis have undergone thorough testing in large randomized clinical trials that showed different results. I am skeptical whether any of the purported benefits of these supplements would be confirmed in a high-quality randomized controlled trial,” he said.
Dr. Nissen added that many of the included studies are low in quality. “I must quote [renowned cardiologist, Dr.] Franz Messerli: ‘A meta-analysis is like making bouillabaisse. ... One rotten fish can spoil the broth.’ This type of analysis does not override high-quality large, randomized trials.”
In the JACC paper, the study investigators note that the American Heart Association now recommends dietary patterns, including the Mediterranean diet and DASH (the Dietary Approach to Stop Hypertension), as preventive or treatment approaches for cardiovascular disease. A common feature of these dietary patterns is that they are low in saturated fat and sodium and rich in micronutrients such as phytochemicals, unsaturated fatty acids, antioxidant vitamins, and minerals.
“To personalize cardiometabolic preventive and therapeutic dietary practices, it is of critical importance to have a comprehensive and in-depth understanding of the balance of benefits and risks associated with constituent micronutrients in diverse dietary patterns,” they note.
They therefore conducted the current systematic review and meta-analyses of all available randomized controlled trials investigating the effect of micronutrients with antioxidant properties on cardiovascular risk factors and events in diverse populations.
The meta-analysis included a total of 884 randomized trials evaluating 27 types of micronutrients among 883,627 participants.
Results showed that supplementation with n-3 fatty acids, n-6 fatty acids, L-arginine, L-citrulline, folic acid, magnesium, zinc, alpha-lipoic acid, coenzyme Q10, melatonin, catechin, curcumin, flavanol, genistein, and quercetin had “moderate-to high-quality evidence” for reducing cardiovascular risk factors.
Specifically, n-3 fatty acid supplementation was linked to reduced rates of cardiovascular mortality (relative risk, 0.93), myocardial infarction (RR, 0.85), and coronary heart disease events (RR, 0.86). Folic acid supplementation was linked to a decreased stroke risk (RR, 0.84) and coenzyme Q10 was associated with a lower rate of all-cause mortality (RR, 0.68).
“The current study represents the first attempt in providing a comprehensive and most up-to-date evidence map that systematically assessed the quality and quantity of all randomized trials linking the effects of a wide variety of micronutrients on cardiovascular risk factors,” the authors say.
“The comprehensive evidence map presented here highlights the importance of micronutrient diversity and the balance of benefits and risks in the design of whole food–based dietary patterns to promote cardiometabolic health, which may require cultural adaptations to apply globally,” they conclude.
Commenting on some of the specific beneficial findings, Dr. Manson said: “I do believe that the marine omega-3s confer heart benefits, but results are not consistent and vary by dose and formulation.”
However, she pointed out that, regarding folic acid, a previous meta-analysis including eight large randomized trials in more than 37,000 participants found no reduction in coronary events, stroke, or major cardiovascular events with folic acid supplementation, compared with placebo, “so the reported stroke benefit would need further confirmation.”
In an accompanying editorial, Juan Gormaz, PhD, University of Chile, and Rodrigo Carrasco, MD, Chilean Society of Cardiology and Cardiovascular Surgery, both in Santiago, state: “Given that the compounds with more pleiotropic properties produced the better outcomes, the antioxidant paradigm on cardiovascular prevention can be challenged. For example, inasmuch as n-3 fatty acids have antiplatelet and anti-inflammatory properties, they are too complex to enable attribution of the observed benefits solely to their antioxidant capacity.”
The editorialists note that from a research point of view, “although the current information opens interesting perspectives for future consolidation of some antioxidants in preventive cardiology, there is still a long way to go in terms of generating evidence.”
They add that the challenge now for some compounds is to begin establishing consensus in definitions of dose and combinations, as well as continue strengthening the evidence of effectiveness.
“Regarding routine clinical practice, these results begin to open spaces for the integration of new tools into the therapeutic arsenal aimed at cardiovascular prevention in selected populations, which could be easily accessible and, with specific exceptions, would present a low frequency of adverse effects,” they conclude.
This work was partly supported by the United States’ Fulbright Program and by the Beijing Advanced Innovation Center for Food Nutrition and Human Health, the National Natural Science Foundation of China, the Chinese Universities Scientific Fund, and the Beijing Municipal Natural Science Foundation.
Dr. Liu has received honoraria for scientific presentations or reviews at Johns Hopkins University, Fred Hutchinson Cancer Center, Harvard University, University of Buffalo, Guangdong General Hospital, Fuwai Hospital, Chinese Academy of Medical Sciences, and the National Institutes of Health; he is a member of the Data Safety and Monitoring Board for several trials, including the SELECT (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity) trial sponsored by Novo Nordisk and a trial of pulmonary hypertension in diabetes patients sponsored by Massachusetts General Hospital; he has received royalties from UpToDate and has received an honorarium from the American Society for Nutrition for his duties as Associate Editor. Co-author Jeffrey Mechanick, MD, has received honoraria from Abbott Nutrition for lectures and serves on the advisory boards of Aveta.Life, L-Nutra, and Twin Health. The other authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JACC
Ultraprocessed foods tied to faster rate of cognitive decline
Results from the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil), which included more than 10,000 people aged 35 and older, showed that higher intake of UPF was significantly associated with a faster rate of decline in executive and global cognitive function.
“These findings show that lifestyle choices, particularly high intake of ultraprocessed foods, can influence our cognitive health many years later,” coinvestigator Natalia Goncalves, PhD, University of São Paulo, Brazil, said in an interview.
The study was published online in JAMA Neurology.
The study’s findings were presented in August at the Alzheimer’s Association International Conference (AAIC) 2022 and were reported by this news organization at that time.
High sugar, salt, fat
The new results align with another recent study linking a diet high in UPFs to an increased risk for dementia.
UPFs are highly manipulated, are packed with added ingredients, including sugar, fat, and salt, and are low in protein and fiber. Examples of UPFs are soft drinks, chips, chocolate, candy, ice cream, sweetened breakfast cereals, packaged soups, chicken nuggets, hot dogs, and fries.
The ELSA-Brasil study comprised 10,775 adults (mean age, 50.6 years at baseline; 55% women; 53% White) who were evaluated in three waves approximately 4 years apart from 2008 to 2017.
Information on diet was obtained via food frequency questionnaires and included details regarding consumption of unprocessed foods, minimally processed foods, and UPFs.
Participants were grouped according to UPF consumption quartiles (lowest to highest). Cognitive performance was evaluated by use of a standardized battery of tests.
During median follow-up of 8 years, people who consumed more than 20% of daily calories from UPFs (quartiles 2-4) experienced a 28% faster rate of decline in global cognition (beta = –0.004; 95% confidence interval [CI], –0.006 to –0.001; P = .003) and a 25% faster rate of decline in executive function (beta = –0.003, 95% CI, –0.005 to 0.000; P = .01) compared to peers in quartile 1 who consumed less than 20% of daily calories from UPFs.
The researchers did not investigate individual groups of UPFs.
However, Dr. Goncalves noted that some studies have linked the consumption of sugar-sweetened beverages with lower cognitive performance, lower brain volume, and poorer memory performance. Another group of ultraprocessed foods, processed meats, has been associated with increased all-cause dementia and Alzheimer’s disease.
Other limitations include the fact that self-reported diet habits were assessed only at baseline using a food frequency questionnaire that was not designed to assess the degree of processing.
While analyses were adjusted for several sociodemographic and clinical confounders, the researchers said they could not exclude the possibility of residual confounding.
Also, since neuroimaging is not available in the ELSA-Brasil study, they were not able to investigate potential mechanisms that could explain the association between higher UPF consumption and cognitive decline.
Despite these limitations, the researchers said their findings suggest that “limiting UPF consumption, particularly in middle-aged adults, may be an efficient form to prevent cognitive decline.”
Weighing the evidence
Several experts weighed in on the results in a statement from the UK nonprofit organization, Science Media Centre.
Kevin McConway, PhD, with Open University, Milton Keynes, England, said it’s important to note that the study suggests “an association, a correlation, and that doesn’t necessarily mean that the cognitive decline was caused by eating more ultra-processed foods.”
He also noted that some types of cognitive decline that are associated with aging occurred in participants in all four quartiles, which were defined by the percentage of their daily energy that came from consuming UPFs.
“That’s hardly surprising – it’s a sad fact of life that pretty well all of us gradually lose some of our cognitive functions as we go through middle and older age,” Dr. McConway said.
“The study doesn’t establish that differences in speed of cognitive decline are caused by ultra-processed food consumption anyway. That’s because it’s an observational study. If the consumption of ultra-processed food causes the differences in rate of cognitive decline, then eating less of it might slow cognitive decline, but if the cause is something else, then that won’t happen,” Dr. McConway added.
Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading, England, noted that UPFs have become a “fashionable term to explain associations between diet and ill health, and many studies have attempted to show associations.
“Most studies have been observational and had a key limitation: It is very difficult to determine ultra-processed food intake using methods that are not designed to do so, and so authors need to make a lot of assumptions. Bread and meat products are often classed as ‘ultra-processed,’ even though this is often wrong,” Dr. Kuhnle noted.
“The same applies to this study – the method used to measure ultra-processed food intake was not designed for that task and relied on assumptions. This makes it virtually impossible to draw any conclusions,” Dr. Kuhnle said.
Duane Mellor, PhD, RD, RNutr, registered dietitian and senior teaching fellow, Aston University, Birmingham, England, said the study does not change how we should try to eat to maintain good brain function and cognition.
“We should try to eat less foods which are high in added sugar, salt, and fat, which would include many of the foods classified as being ultra-processed, while eating more in terms of both quantity and variety of vegetables, fruit, nuts, seeds, and pulses, which are known to be beneficial for both our cognitive and overall health,” Dr. Mellor said.
The ELSA-Brasil study was supported by the Brazilian Ministry of Health, the Ministry of Science, Technology and Innovation, and the National Council for Scientific and Technological Development. The authors as well as Dr. McConway, Dr. Mellor, and Dr. Kuhnle have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Results from the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil), which included more than 10,000 people aged 35 and older, showed that higher intake of UPF was significantly associated with a faster rate of decline in executive and global cognitive function.
“These findings show that lifestyle choices, particularly high intake of ultraprocessed foods, can influence our cognitive health many years later,” coinvestigator Natalia Goncalves, PhD, University of São Paulo, Brazil, said in an interview.
The study was published online in JAMA Neurology.
The study’s findings were presented in August at the Alzheimer’s Association International Conference (AAIC) 2022 and were reported by this news organization at that time.
High sugar, salt, fat
The new results align with another recent study linking a diet high in UPFs to an increased risk for dementia.
UPFs are highly manipulated, are packed with added ingredients, including sugar, fat, and salt, and are low in protein and fiber. Examples of UPFs are soft drinks, chips, chocolate, candy, ice cream, sweetened breakfast cereals, packaged soups, chicken nuggets, hot dogs, and fries.
The ELSA-Brasil study comprised 10,775 adults (mean age, 50.6 years at baseline; 55% women; 53% White) who were evaluated in three waves approximately 4 years apart from 2008 to 2017.
Information on diet was obtained via food frequency questionnaires and included details regarding consumption of unprocessed foods, minimally processed foods, and UPFs.
Participants were grouped according to UPF consumption quartiles (lowest to highest). Cognitive performance was evaluated by use of a standardized battery of tests.
During median follow-up of 8 years, people who consumed more than 20% of daily calories from UPFs (quartiles 2-4) experienced a 28% faster rate of decline in global cognition (beta = –0.004; 95% confidence interval [CI], –0.006 to –0.001; P = .003) and a 25% faster rate of decline in executive function (beta = –0.003, 95% CI, –0.005 to 0.000; P = .01) compared to peers in quartile 1 who consumed less than 20% of daily calories from UPFs.
The researchers did not investigate individual groups of UPFs.
However, Dr. Goncalves noted that some studies have linked the consumption of sugar-sweetened beverages with lower cognitive performance, lower brain volume, and poorer memory performance. Another group of ultraprocessed foods, processed meats, has been associated with increased all-cause dementia and Alzheimer’s disease.
Other limitations include the fact that self-reported diet habits were assessed only at baseline using a food frequency questionnaire that was not designed to assess the degree of processing.
While analyses were adjusted for several sociodemographic and clinical confounders, the researchers said they could not exclude the possibility of residual confounding.
Also, since neuroimaging is not available in the ELSA-Brasil study, they were not able to investigate potential mechanisms that could explain the association between higher UPF consumption and cognitive decline.
Despite these limitations, the researchers said their findings suggest that “limiting UPF consumption, particularly in middle-aged adults, may be an efficient form to prevent cognitive decline.”
Weighing the evidence
Several experts weighed in on the results in a statement from the UK nonprofit organization, Science Media Centre.
Kevin McConway, PhD, with Open University, Milton Keynes, England, said it’s important to note that the study suggests “an association, a correlation, and that doesn’t necessarily mean that the cognitive decline was caused by eating more ultra-processed foods.”
He also noted that some types of cognitive decline that are associated with aging occurred in participants in all four quartiles, which were defined by the percentage of their daily energy that came from consuming UPFs.
“That’s hardly surprising – it’s a sad fact of life that pretty well all of us gradually lose some of our cognitive functions as we go through middle and older age,” Dr. McConway said.
“The study doesn’t establish that differences in speed of cognitive decline are caused by ultra-processed food consumption anyway. That’s because it’s an observational study. If the consumption of ultra-processed food causes the differences in rate of cognitive decline, then eating less of it might slow cognitive decline, but if the cause is something else, then that won’t happen,” Dr. McConway added.
Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading, England, noted that UPFs have become a “fashionable term to explain associations between diet and ill health, and many studies have attempted to show associations.
“Most studies have been observational and had a key limitation: It is very difficult to determine ultra-processed food intake using methods that are not designed to do so, and so authors need to make a lot of assumptions. Bread and meat products are often classed as ‘ultra-processed,’ even though this is often wrong,” Dr. Kuhnle noted.
“The same applies to this study – the method used to measure ultra-processed food intake was not designed for that task and relied on assumptions. This makes it virtually impossible to draw any conclusions,” Dr. Kuhnle said.
Duane Mellor, PhD, RD, RNutr, registered dietitian and senior teaching fellow, Aston University, Birmingham, England, said the study does not change how we should try to eat to maintain good brain function and cognition.
“We should try to eat less foods which are high in added sugar, salt, and fat, which would include many of the foods classified as being ultra-processed, while eating more in terms of both quantity and variety of vegetables, fruit, nuts, seeds, and pulses, which are known to be beneficial for both our cognitive and overall health,” Dr. Mellor said.
The ELSA-Brasil study was supported by the Brazilian Ministry of Health, the Ministry of Science, Technology and Innovation, and the National Council for Scientific and Technological Development. The authors as well as Dr. McConway, Dr. Mellor, and Dr. Kuhnle have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Results from the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil), which included more than 10,000 people aged 35 and older, showed that higher intake of UPF was significantly associated with a faster rate of decline in executive and global cognitive function.
“These findings show that lifestyle choices, particularly high intake of ultraprocessed foods, can influence our cognitive health many years later,” coinvestigator Natalia Goncalves, PhD, University of São Paulo, Brazil, said in an interview.
The study was published online in JAMA Neurology.
The study’s findings were presented in August at the Alzheimer’s Association International Conference (AAIC) 2022 and were reported by this news organization at that time.
High sugar, salt, fat
The new results align with another recent study linking a diet high in UPFs to an increased risk for dementia.
UPFs are highly manipulated, are packed with added ingredients, including sugar, fat, and salt, and are low in protein and fiber. Examples of UPFs are soft drinks, chips, chocolate, candy, ice cream, sweetened breakfast cereals, packaged soups, chicken nuggets, hot dogs, and fries.
The ELSA-Brasil study comprised 10,775 adults (mean age, 50.6 years at baseline; 55% women; 53% White) who were evaluated in three waves approximately 4 years apart from 2008 to 2017.
Information on diet was obtained via food frequency questionnaires and included details regarding consumption of unprocessed foods, minimally processed foods, and UPFs.
Participants were grouped according to UPF consumption quartiles (lowest to highest). Cognitive performance was evaluated by use of a standardized battery of tests.
During median follow-up of 8 years, people who consumed more than 20% of daily calories from UPFs (quartiles 2-4) experienced a 28% faster rate of decline in global cognition (beta = –0.004; 95% confidence interval [CI], –0.006 to –0.001; P = .003) and a 25% faster rate of decline in executive function (beta = –0.003, 95% CI, –0.005 to 0.000; P = .01) compared to peers in quartile 1 who consumed less than 20% of daily calories from UPFs.
The researchers did not investigate individual groups of UPFs.
However, Dr. Goncalves noted that some studies have linked the consumption of sugar-sweetened beverages with lower cognitive performance, lower brain volume, and poorer memory performance. Another group of ultraprocessed foods, processed meats, has been associated with increased all-cause dementia and Alzheimer’s disease.
Other limitations include the fact that self-reported diet habits were assessed only at baseline using a food frequency questionnaire that was not designed to assess the degree of processing.
While analyses were adjusted for several sociodemographic and clinical confounders, the researchers said they could not exclude the possibility of residual confounding.
Also, since neuroimaging is not available in the ELSA-Brasil study, they were not able to investigate potential mechanisms that could explain the association between higher UPF consumption and cognitive decline.
Despite these limitations, the researchers said their findings suggest that “limiting UPF consumption, particularly in middle-aged adults, may be an efficient form to prevent cognitive decline.”
Weighing the evidence
Several experts weighed in on the results in a statement from the UK nonprofit organization, Science Media Centre.
Kevin McConway, PhD, with Open University, Milton Keynes, England, said it’s important to note that the study suggests “an association, a correlation, and that doesn’t necessarily mean that the cognitive decline was caused by eating more ultra-processed foods.”
He also noted that some types of cognitive decline that are associated with aging occurred in participants in all four quartiles, which were defined by the percentage of their daily energy that came from consuming UPFs.
“That’s hardly surprising – it’s a sad fact of life that pretty well all of us gradually lose some of our cognitive functions as we go through middle and older age,” Dr. McConway said.
“The study doesn’t establish that differences in speed of cognitive decline are caused by ultra-processed food consumption anyway. That’s because it’s an observational study. If the consumption of ultra-processed food causes the differences in rate of cognitive decline, then eating less of it might slow cognitive decline, but if the cause is something else, then that won’t happen,” Dr. McConway added.
Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading, England, noted that UPFs have become a “fashionable term to explain associations between diet and ill health, and many studies have attempted to show associations.
“Most studies have been observational and had a key limitation: It is very difficult to determine ultra-processed food intake using methods that are not designed to do so, and so authors need to make a lot of assumptions. Bread and meat products are often classed as ‘ultra-processed,’ even though this is often wrong,” Dr. Kuhnle noted.
“The same applies to this study – the method used to measure ultra-processed food intake was not designed for that task and relied on assumptions. This makes it virtually impossible to draw any conclusions,” Dr. Kuhnle said.
Duane Mellor, PhD, RD, RNutr, registered dietitian and senior teaching fellow, Aston University, Birmingham, England, said the study does not change how we should try to eat to maintain good brain function and cognition.
“We should try to eat less foods which are high in added sugar, salt, and fat, which would include many of the foods classified as being ultra-processed, while eating more in terms of both quantity and variety of vegetables, fruit, nuts, seeds, and pulses, which are known to be beneficial for both our cognitive and overall health,” Dr. Mellor said.
The ELSA-Brasil study was supported by the Brazilian Ministry of Health, the Ministry of Science, Technology and Innovation, and the National Council for Scientific and Technological Development. The authors as well as Dr. McConway, Dr. Mellor, and Dr. Kuhnle have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NEUROLOGY
‘Meth’ heart failure on the rise, often more severe
a literature review indicates.
MethHF is associated with increased severity for HF, longer inpatient stay, and more readmissions, compared with non-MethHF, the data show.
Clinicians “need to consider methamphetamine as a potential etiology for heart failure and include a substance use history when evaluating patients. Treating methamphetamine use disorder improves heart failure outcomes,” first author Veena Manja, MD, PhD, with Stanford (Calif.) University, said in an interview.
The study was published online in the journal Heart.
Poor outcomes, ‘staggering’ costs
This “thoughtful” review is “important and necessary,” Jonathan Davis, MD, director of the heart failure program, Zuckerberg San Francisco General Hospital, wrote in an editorial in the journal.
Dr. Davis noted that patients with Meth HF are at increased risk for poor outcomes and death and the health care costs related to MethHF are “staggering.”
As an example, inpatient data for California show annual charges related to MethHF rose by 840% from 2008 to 2018, from $41.5 million to $390.2 million, compared with 82% for all HF, which rose from $3.5 billion to $6.8 billion.
Illicit use of methamphetamine – also known as “crystal meth,” “ice,” and “speed” – has been linked to hypertension, MI, stroke, aortic dissection, and sudden death. But until now, there was no comprehensive systematic review of published studies on MethHF.
“Our goal was to compile current knowledge on the topic, increase awareness of this condition and identify areas for future research,” Dr. Manja said.
The researchers reviewed 21 observational studies, mostly from the United States (14 from California), between 1997 and 2020. The mean age of adults with MethHF ranged in age from 35 to 60 and more than half were male (57%).
Illicit methamphetamine was inhaled, injected, swallowed, smoked, and snorted. The reported frequency ranged from daily to every other week, and the total monthly dose ranged from 0.35 g to 24.5 g.
The average duration of meth use before HF diagnosis was 5 years. However, 18% of users developed HF within 1 year of starting to use illicit methamphetamine. In some cases, HF was diagnosed after a single use.
The researchers also note that MethHF with preserved left ventricular ejection fraction, seen in up to 44% of cases, is a distinct entity that may progress to reduced LVEF with continued use.
MethHF is also associated with a greater likelihood of other substance abuse, PTSD, depression, and other heart and kidney disease.
Factors associated with improved MethHF outcomes include female sex, meth abstinence, and adherence to guideline-directed HF therapy.
Improvement in MethHF outcomes is possible even if abstinence is not consistent, a finding that lends support to harm reduction principles of “meeting patients where they are instead of insisting on complete abstinence,” the researchers said.
Large gaps in knowledge
They were unable to combine the results into a meta-analysis because of heterogeneity in study design, population, comparator, and outcome assessment. Also, the overall risk of bias is moderate because of the presence of confounders, selection bias and poor matching, and the overall certainty in the evidence is very low,.
No study evaluated the incidence or prevalence of HF among methamphetamine users and inconsistent history taking and testing in patients with HF impeded accurate MethHF prevalence assessment.
Several studies, however, document an increasing incidence of MethHF, particularly over the past decade.
One study from California reported a 585% increase in MethHF hospital admissions between 2008 and 2018. An analysis of the National Inpatient Survey found a 12-fold increase in annual MethHF hospitalizations between 2002 and 2014.
“The results of this systematic review highlight large gaps in our knowledge” of MethHF, Dr. Manja said in an interview.
“We need to understand the epidemiology, prevalence, factors that confer susceptibility to cardiovascular outcomes, and need research into treatment targeted toward this disease,” Dr. Manja added. “We should consider options to integrate substance use treatment in HF/cardiology/primary care clinics and design a multidisciplinary patient-centered approach.”
Dr. Davis agreed. This work “highlights that the standard of care academically and clinically must be a broad team across the care spectrum to simultaneously address methamphetamine use, heart failure, and social determinants of health.”
This research had no specific funding. Dr. Manja and Dr. Davis reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
a literature review indicates.
MethHF is associated with increased severity for HF, longer inpatient stay, and more readmissions, compared with non-MethHF, the data show.
Clinicians “need to consider methamphetamine as a potential etiology for heart failure and include a substance use history when evaluating patients. Treating methamphetamine use disorder improves heart failure outcomes,” first author Veena Manja, MD, PhD, with Stanford (Calif.) University, said in an interview.
The study was published online in the journal Heart.
Poor outcomes, ‘staggering’ costs
This “thoughtful” review is “important and necessary,” Jonathan Davis, MD, director of the heart failure program, Zuckerberg San Francisco General Hospital, wrote in an editorial in the journal.
Dr. Davis noted that patients with Meth HF are at increased risk for poor outcomes and death and the health care costs related to MethHF are “staggering.”
As an example, inpatient data for California show annual charges related to MethHF rose by 840% from 2008 to 2018, from $41.5 million to $390.2 million, compared with 82% for all HF, which rose from $3.5 billion to $6.8 billion.
Illicit use of methamphetamine – also known as “crystal meth,” “ice,” and “speed” – has been linked to hypertension, MI, stroke, aortic dissection, and sudden death. But until now, there was no comprehensive systematic review of published studies on MethHF.
“Our goal was to compile current knowledge on the topic, increase awareness of this condition and identify areas for future research,” Dr. Manja said.
The researchers reviewed 21 observational studies, mostly from the United States (14 from California), between 1997 and 2020. The mean age of adults with MethHF ranged in age from 35 to 60 and more than half were male (57%).
Illicit methamphetamine was inhaled, injected, swallowed, smoked, and snorted. The reported frequency ranged from daily to every other week, and the total monthly dose ranged from 0.35 g to 24.5 g.
The average duration of meth use before HF diagnosis was 5 years. However, 18% of users developed HF within 1 year of starting to use illicit methamphetamine. In some cases, HF was diagnosed after a single use.
The researchers also note that MethHF with preserved left ventricular ejection fraction, seen in up to 44% of cases, is a distinct entity that may progress to reduced LVEF with continued use.
MethHF is also associated with a greater likelihood of other substance abuse, PTSD, depression, and other heart and kidney disease.
Factors associated with improved MethHF outcomes include female sex, meth abstinence, and adherence to guideline-directed HF therapy.
Improvement in MethHF outcomes is possible even if abstinence is not consistent, a finding that lends support to harm reduction principles of “meeting patients where they are instead of insisting on complete abstinence,” the researchers said.
Large gaps in knowledge
They were unable to combine the results into a meta-analysis because of heterogeneity in study design, population, comparator, and outcome assessment. Also, the overall risk of bias is moderate because of the presence of confounders, selection bias and poor matching, and the overall certainty in the evidence is very low,.
No study evaluated the incidence or prevalence of HF among methamphetamine users and inconsistent history taking and testing in patients with HF impeded accurate MethHF prevalence assessment.
Several studies, however, document an increasing incidence of MethHF, particularly over the past decade.
One study from California reported a 585% increase in MethHF hospital admissions between 2008 and 2018. An analysis of the National Inpatient Survey found a 12-fold increase in annual MethHF hospitalizations between 2002 and 2014.
“The results of this systematic review highlight large gaps in our knowledge” of MethHF, Dr. Manja said in an interview.
“We need to understand the epidemiology, prevalence, factors that confer susceptibility to cardiovascular outcomes, and need research into treatment targeted toward this disease,” Dr. Manja added. “We should consider options to integrate substance use treatment in HF/cardiology/primary care clinics and design a multidisciplinary patient-centered approach.”
Dr. Davis agreed. This work “highlights that the standard of care academically and clinically must be a broad team across the care spectrum to simultaneously address methamphetamine use, heart failure, and social determinants of health.”
This research had no specific funding. Dr. Manja and Dr. Davis reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
a literature review indicates.
MethHF is associated with increased severity for HF, longer inpatient stay, and more readmissions, compared with non-MethHF, the data show.
Clinicians “need to consider methamphetamine as a potential etiology for heart failure and include a substance use history when evaluating patients. Treating methamphetamine use disorder improves heart failure outcomes,” first author Veena Manja, MD, PhD, with Stanford (Calif.) University, said in an interview.
The study was published online in the journal Heart.
Poor outcomes, ‘staggering’ costs
This “thoughtful” review is “important and necessary,” Jonathan Davis, MD, director of the heart failure program, Zuckerberg San Francisco General Hospital, wrote in an editorial in the journal.
Dr. Davis noted that patients with Meth HF are at increased risk for poor outcomes and death and the health care costs related to MethHF are “staggering.”
As an example, inpatient data for California show annual charges related to MethHF rose by 840% from 2008 to 2018, from $41.5 million to $390.2 million, compared with 82% for all HF, which rose from $3.5 billion to $6.8 billion.
Illicit use of methamphetamine – also known as “crystal meth,” “ice,” and “speed” – has been linked to hypertension, MI, stroke, aortic dissection, and sudden death. But until now, there was no comprehensive systematic review of published studies on MethHF.
“Our goal was to compile current knowledge on the topic, increase awareness of this condition and identify areas for future research,” Dr. Manja said.
The researchers reviewed 21 observational studies, mostly from the United States (14 from California), between 1997 and 2020. The mean age of adults with MethHF ranged in age from 35 to 60 and more than half were male (57%).
Illicit methamphetamine was inhaled, injected, swallowed, smoked, and snorted. The reported frequency ranged from daily to every other week, and the total monthly dose ranged from 0.35 g to 24.5 g.
The average duration of meth use before HF diagnosis was 5 years. However, 18% of users developed HF within 1 year of starting to use illicit methamphetamine. In some cases, HF was diagnosed after a single use.
The researchers also note that MethHF with preserved left ventricular ejection fraction, seen in up to 44% of cases, is a distinct entity that may progress to reduced LVEF with continued use.
MethHF is also associated with a greater likelihood of other substance abuse, PTSD, depression, and other heart and kidney disease.
Factors associated with improved MethHF outcomes include female sex, meth abstinence, and adherence to guideline-directed HF therapy.
Improvement in MethHF outcomes is possible even if abstinence is not consistent, a finding that lends support to harm reduction principles of “meeting patients where they are instead of insisting on complete abstinence,” the researchers said.
Large gaps in knowledge
They were unable to combine the results into a meta-analysis because of heterogeneity in study design, population, comparator, and outcome assessment. Also, the overall risk of bias is moderate because of the presence of confounders, selection bias and poor matching, and the overall certainty in the evidence is very low,.
No study evaluated the incidence or prevalence of HF among methamphetamine users and inconsistent history taking and testing in patients with HF impeded accurate MethHF prevalence assessment.
Several studies, however, document an increasing incidence of MethHF, particularly over the past decade.
One study from California reported a 585% increase in MethHF hospital admissions between 2008 and 2018. An analysis of the National Inpatient Survey found a 12-fold increase in annual MethHF hospitalizations between 2002 and 2014.
“The results of this systematic review highlight large gaps in our knowledge” of MethHF, Dr. Manja said in an interview.
“We need to understand the epidemiology, prevalence, factors that confer susceptibility to cardiovascular outcomes, and need research into treatment targeted toward this disease,” Dr. Manja added. “We should consider options to integrate substance use treatment in HF/cardiology/primary care clinics and design a multidisciplinary patient-centered approach.”
Dr. Davis agreed. This work “highlights that the standard of care academically and clinically must be a broad team across the care spectrum to simultaneously address methamphetamine use, heart failure, and social determinants of health.”
This research had no specific funding. Dr. Manja and Dr. Davis reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM HEART
New melting hydrogel bandage could treat burn wounds faster, with less pain
Surgically debriding burn wounds can be tedious for doctors and excruciating for patients. To change that, bioengineers have created a new hydrogel formula that dissolves rapidly from wound sites, melting off in 6 minutes or less.
“The removal of dressings, with the current standard of care, is very hard and time-consuming. It becomes very painful for the patient. People are screaming, or they’re given a lot of opioids,” said senior author O. Berk Usta, PhD, of the Center for Engineering in Medicine and Surgery at Massachusetts General Hospital, Boston. “Those are the things we wanted to minimize: the pain and the time.”
Although beneficial for all patients, a short, painless bandage change would be a particular boon for younger patients. At the pediatric burns care center at Shriners Hospitals for Children (an MGH partner), researchers “observe a lot of children who go through therapy or treatment after burns,” said Dr. Usta. The team at MGH collaborated with scientists at Tufts University, Boston, with those patients in mind, setting out to create a new hydrogel that would transform burn wound care.
A better bandage
Hydrogels provide cooling relief to burn wounds and maintain a moist environment that can speed healing. There are currently hydrogel sheets and hydrogel-infused dressings, as well as gel that is applied directly to burn wounds before being covered with protective material. These dressings must be replaced frequently to prevent infections, but that can be unbearably painful and drawn out, as dressings often stick to wounds.
Mechanical debridement can be especially difficult for second-degree burn patients, whose wounds may still retain nerve endings. Debridement tends to also remove some healthy tissue and can damage newly formed tissue, slowing down healing.
“It can take up to 2, 3 hours, and it requires multiple people working on it,” said Dr. Usta.
The new hydrogel treatment can be applied directly to a wound and it forms a protective barrier around the site in 15 seconds. The hydrogel is then covered by a protective dressing until it needs to be changed.
“After you take off the protective covering, you add another solution, which dissolves the [hydrogel] dressing, so that it can be easily removed from the burn site,” Dr. Usta said.
The solution dissolves the hydrogel in 4-6 minutes.
Hybrid gels
Many hydrogels currently used for burn wounds feature physically cross-linked molecules. This makes them strong and capable of retaining moisture, but also difficult to dissolve. The researchers used a different approach.
“This is not physical cross-linking like the traditional approaches, but rather, softer covalent bonds between the different molecules. And that’s why, when you bring in another solution, the hydrogel dissolves away,” Dr. Usta said.
The new hydrogels rely on a supramolecular assembly: a network of synthetic polymers whose connections can be reversed more easily, meaning they can be dissolved quickly. Another standout feature of the new hydrogels is their hybrid composition, displaying characteristics of both liquids and solids. The polymers are knitted together into a mesh-like network that enables water retention, with the goal of maintaining the moist environment needed for wound healing.
The supramolecular assembly is also greener, Dr. Usta explained; traditional cross-linking approaches produce a lot of toxic by-products that could harm the environment.
And whereas traditional hydrogels can require a dozen chemistry steps to produce, the new hydrogels are ready after mixing two solutions, Dr. Usta explained. This makes them easy to prepare at bedside, ideal for treating large wounds in the ER or even on battlefields.
When tested in vitro, using skin cells, and in vivo, on mice, the new hydrogels were shown to be safe to use on wounds. Additional studies on mice, as well as large animals, will focus on safety and efficacy, and may be followed by human clinical trials, said Dr. Usta.
“The next phase of the project will be to look at whether these dressings will help wound healing by creating a moist environment,” said Dr. Usta.
The researchers are also exploring how to manufacture individual prewrapped hydrogels that could be applied in a clinical setting – or even in people’s homes. The consumer market is “another possibility,” said Dr. Usta, particularly among patients with “smaller, more superficial burns” or patients whose large burn wounds are still healing once they leave the hospital.
This research was supported by the National Institutes of Health, National Science Foundation, Massachusetts General Hospital Executive Committee on Research Interim Support Fund, and Shriners Hospitals.
A version of this article first appeared on Medscape.com.
Surgically debriding burn wounds can be tedious for doctors and excruciating for patients. To change that, bioengineers have created a new hydrogel formula that dissolves rapidly from wound sites, melting off in 6 minutes or less.
“The removal of dressings, with the current standard of care, is very hard and time-consuming. It becomes very painful for the patient. People are screaming, or they’re given a lot of opioids,” said senior author O. Berk Usta, PhD, of the Center for Engineering in Medicine and Surgery at Massachusetts General Hospital, Boston. “Those are the things we wanted to minimize: the pain and the time.”
Although beneficial for all patients, a short, painless bandage change would be a particular boon for younger patients. At the pediatric burns care center at Shriners Hospitals for Children (an MGH partner), researchers “observe a lot of children who go through therapy or treatment after burns,” said Dr. Usta. The team at MGH collaborated with scientists at Tufts University, Boston, with those patients in mind, setting out to create a new hydrogel that would transform burn wound care.
A better bandage
Hydrogels provide cooling relief to burn wounds and maintain a moist environment that can speed healing. There are currently hydrogel sheets and hydrogel-infused dressings, as well as gel that is applied directly to burn wounds before being covered with protective material. These dressings must be replaced frequently to prevent infections, but that can be unbearably painful and drawn out, as dressings often stick to wounds.
Mechanical debridement can be especially difficult for second-degree burn patients, whose wounds may still retain nerve endings. Debridement tends to also remove some healthy tissue and can damage newly formed tissue, slowing down healing.
“It can take up to 2, 3 hours, and it requires multiple people working on it,” said Dr. Usta.
The new hydrogel treatment can be applied directly to a wound and it forms a protective barrier around the site in 15 seconds. The hydrogel is then covered by a protective dressing until it needs to be changed.
“After you take off the protective covering, you add another solution, which dissolves the [hydrogel] dressing, so that it can be easily removed from the burn site,” Dr. Usta said.
The solution dissolves the hydrogel in 4-6 minutes.
Hybrid gels
Many hydrogels currently used for burn wounds feature physically cross-linked molecules. This makes them strong and capable of retaining moisture, but also difficult to dissolve. The researchers used a different approach.
“This is not physical cross-linking like the traditional approaches, but rather, softer covalent bonds between the different molecules. And that’s why, when you bring in another solution, the hydrogel dissolves away,” Dr. Usta said.
The new hydrogels rely on a supramolecular assembly: a network of synthetic polymers whose connections can be reversed more easily, meaning they can be dissolved quickly. Another standout feature of the new hydrogels is their hybrid composition, displaying characteristics of both liquids and solids. The polymers are knitted together into a mesh-like network that enables water retention, with the goal of maintaining the moist environment needed for wound healing.
The supramolecular assembly is also greener, Dr. Usta explained; traditional cross-linking approaches produce a lot of toxic by-products that could harm the environment.
And whereas traditional hydrogels can require a dozen chemistry steps to produce, the new hydrogels are ready after mixing two solutions, Dr. Usta explained. This makes them easy to prepare at bedside, ideal for treating large wounds in the ER or even on battlefields.
When tested in vitro, using skin cells, and in vivo, on mice, the new hydrogels were shown to be safe to use on wounds. Additional studies on mice, as well as large animals, will focus on safety and efficacy, and may be followed by human clinical trials, said Dr. Usta.
“The next phase of the project will be to look at whether these dressings will help wound healing by creating a moist environment,” said Dr. Usta.
The researchers are also exploring how to manufacture individual prewrapped hydrogels that could be applied in a clinical setting – or even in people’s homes. The consumer market is “another possibility,” said Dr. Usta, particularly among patients with “smaller, more superficial burns” or patients whose large burn wounds are still healing once they leave the hospital.
This research was supported by the National Institutes of Health, National Science Foundation, Massachusetts General Hospital Executive Committee on Research Interim Support Fund, and Shriners Hospitals.
A version of this article first appeared on Medscape.com.
Surgically debriding burn wounds can be tedious for doctors and excruciating for patients. To change that, bioengineers have created a new hydrogel formula that dissolves rapidly from wound sites, melting off in 6 minutes or less.
“The removal of dressings, with the current standard of care, is very hard and time-consuming. It becomes very painful for the patient. People are screaming, or they’re given a lot of opioids,” said senior author O. Berk Usta, PhD, of the Center for Engineering in Medicine and Surgery at Massachusetts General Hospital, Boston. “Those are the things we wanted to minimize: the pain and the time.”
Although beneficial for all patients, a short, painless bandage change would be a particular boon for younger patients. At the pediatric burns care center at Shriners Hospitals for Children (an MGH partner), researchers “observe a lot of children who go through therapy or treatment after burns,” said Dr. Usta. The team at MGH collaborated with scientists at Tufts University, Boston, with those patients in mind, setting out to create a new hydrogel that would transform burn wound care.
A better bandage
Hydrogels provide cooling relief to burn wounds and maintain a moist environment that can speed healing. There are currently hydrogel sheets and hydrogel-infused dressings, as well as gel that is applied directly to burn wounds before being covered with protective material. These dressings must be replaced frequently to prevent infections, but that can be unbearably painful and drawn out, as dressings often stick to wounds.
Mechanical debridement can be especially difficult for second-degree burn patients, whose wounds may still retain nerve endings. Debridement tends to also remove some healthy tissue and can damage newly formed tissue, slowing down healing.
“It can take up to 2, 3 hours, and it requires multiple people working on it,” said Dr. Usta.
The new hydrogel treatment can be applied directly to a wound and it forms a protective barrier around the site in 15 seconds. The hydrogel is then covered by a protective dressing until it needs to be changed.
“After you take off the protective covering, you add another solution, which dissolves the [hydrogel] dressing, so that it can be easily removed from the burn site,” Dr. Usta said.
The solution dissolves the hydrogel in 4-6 minutes.
Hybrid gels
Many hydrogels currently used for burn wounds feature physically cross-linked molecules. This makes them strong and capable of retaining moisture, but also difficult to dissolve. The researchers used a different approach.
“This is not physical cross-linking like the traditional approaches, but rather, softer covalent bonds between the different molecules. And that’s why, when you bring in another solution, the hydrogel dissolves away,” Dr. Usta said.
The new hydrogels rely on a supramolecular assembly: a network of synthetic polymers whose connections can be reversed more easily, meaning they can be dissolved quickly. Another standout feature of the new hydrogels is their hybrid composition, displaying characteristics of both liquids and solids. The polymers are knitted together into a mesh-like network that enables water retention, with the goal of maintaining the moist environment needed for wound healing.
The supramolecular assembly is also greener, Dr. Usta explained; traditional cross-linking approaches produce a lot of toxic by-products that could harm the environment.
And whereas traditional hydrogels can require a dozen chemistry steps to produce, the new hydrogels are ready after mixing two solutions, Dr. Usta explained. This makes them easy to prepare at bedside, ideal for treating large wounds in the ER or even on battlefields.
When tested in vitro, using skin cells, and in vivo, on mice, the new hydrogels were shown to be safe to use on wounds. Additional studies on mice, as well as large animals, will focus on safety and efficacy, and may be followed by human clinical trials, said Dr. Usta.
“The next phase of the project will be to look at whether these dressings will help wound healing by creating a moist environment,” said Dr. Usta.
The researchers are also exploring how to manufacture individual prewrapped hydrogels that could be applied in a clinical setting – or even in people’s homes. The consumer market is “another possibility,” said Dr. Usta, particularly among patients with “smaller, more superficial burns” or patients whose large burn wounds are still healing once they leave the hospital.
This research was supported by the National Institutes of Health, National Science Foundation, Massachusetts General Hospital Executive Committee on Research Interim Support Fund, and Shriners Hospitals.
A version of this article first appeared on Medscape.com.
FROM BIOACTIVE MATERIALS
GOLD Report 2023: Important updates and revisions
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report is revised annually and is used widely throughout the world as a tool for implementing effective management.
Among the updates in the 2023 GOLD Report, the section on diagnostic criteria added a proposed new category “PRISm,” denoting “preserved ratio impaired spirometry,” encompassing individuals who present with structural lung lesions (for example, emphysema) and/or other physiological abnormalities such as low-normal forced expiratory volume in 1 second (FEV1), gas trapping, hyperinflation, reduced lung diffusing capacity and/or rapid FEV1 decline, but without airflow obstruction (FEV1/FEV ≥ 0.7 post bronchodilation). Some of these “pre-COPD” (chronic obstructive pulmonary disease) individuals, who have a normal ratio but abnormal spirometry are at risk over time of developing airflow obstruction. The best treatment for them, beyond smoking cessation, needs to be determined through research, the report states.
Clinical updates
The GOLD 2023 Report also offers proposed clinical guidance, in the absence of high-quality clinical trial evidence, on initial pharmacologic management of COPD. The proposal is based on individual assessment of symptoms and exacerbation risk following use of the ABE Assessment Tool, a revised version of the ABCD Assessment Tool that recognizes the clinical relevance of exacerbations independent of symptom level.
These updates to information and figures pertaining to initial pharmacological treatment and follow-up pharmacological treatment revise the positioning of LABA (long-acting beta2 agonists) plus LAMA (long-acting muscarinic agonists) and LABA/ICS (inhaled corticosteroids). Among GOLD group A patients with 0 or 1 moderate exacerbations that do not lead to hospital admission, a bronchodilator is recommended.
The recommendation for group B patients is LABA/LAMA with the caveat that single inhaler therapy may be more convenient and effective than multiple inhalers. For group E patients with two or more moderate exacerbations or one or more leading to hospitalization, LABA/LAMA is recommended (with the same inhaler therapy caveat). With blood eosinophil levels at 300 or higher, LABA/LAMA/ICS may be considered.
Commenting on the combination recommendations in a press release, Antonio Anzueto, MD, professor of medicine, pulmonary critical care, University of Texas Health, San Antonio, stated: “From a physician’s perspective, we are always grateful to receive well-vetted and informed recommendations on how we can best utilize available treatment options to provide the most benefit to our patients. The new 2023 GOLD recommendations represent a meaningful change for the treatment of COPD by prioritizing the utilization of a fixed LAMA/LABA combination.”
More interventions
In a section on therapeutic interventions to reduce COPD mortality, the report lists studies showing mortality benefits for fixed-dose inhaled triple combinations (LABA + LAMA + ICS) versus dual inhaled long-acting bronchodilations, and for smoking cessation and pulmonary rehabilitation.
Also new is a strong emphasis on inhaler choice, education, and technique training with assessment of inhaler technique and adherence urged as a prerequisite to judging whether current therapy as insufficient. The report summarizes principles guiding inhaler type selection.
The report also added a section on chronic bronchitis, defining it as a common but variable condition in COPD patients with cough and expectorated sputum on a regular basis over a defined period in the absence of other conditions plausibly causing symptoms.
The fact that chronic bronchitis is sometimes found in never-smokers suggests the involvement of other factors such as exposure to inhaled dusts, biomass fuels, chemical fumes, or domestic heating and cooking fuels, according to the report. Gastroesophageal reflux may also be associated with chronic bronchitis.
The report discusses various taxonomic terms for different types of COPD, such as COPD-G for genetically determined COPD, COPD-D for those with abnormal lung development, and COPD-C for COPD associated with cigarette smoking, etc.
Change in exacerbations
The report also revises the definition of a COPD exacerbation as “an event characterized by increased dyspnea and/or cough and sputum that worsens in less than 14 days which may be accompanied by tachypnea and/or tachycardia and is often associated with increased local and system inflammation caused by infection, pollution, or other insult to the airways.” To overcome limitations conferred by the current grading of COPD exacerbations, the 2023 report proposes a four-step point-of-contact diagnosis and assessment tool.
Telemedicine
Given the constraints brought on by COVID-19 on top of the generally sparse availability of programs and facilities for delivering well-proven pulmonary rehabilitation methods, tele-rehabilitation has been proposed as an alternative to traditional approaches. While the evidence base is still evolving and best practices have not yet been established, the GOLD Report calls for better understanding of barriers to tele-rehabilitation success.
Comorbidities update
The GOLD Report chapter on COPD and comorbidities was also updated, and lists cardiovascular disease, lung cancer, osteoporosis, depression/anxiety, and gastroesophageal reflux disease as common comorbid conditions which may affect prognosis and, in the case of cancer, mortality. The report urges simplicity of treatment to minimize polypharmacy. While annual low-dose CT is recommended for COPD caused by smoking, it is not recommended for COPD caused by smoking; data are insufficient to establish benefit over harm.
While the GOLD Report “COVID-19 and COPD” chapter summarizes current evidence stating that individuals with COPD do not seem to be at substantially greater risk of infection with SARS-CoV-2, it underscores that they are at higher risk of hospitalization for COVID-19 and may be at higher risk for developing severe disease and death.
Many other topics are included in the updated report, among them screening, imaging, vaccinations, adherence to therapy, and surgical and bronchoscopic interventions. In its closing section, the GOLD Report 2023 reiterates its mission, stating: “The GOLD initiative will continue to work with National Leaders and other interested health care professionals to bring COPD to the attention of governments, public health officials, health care workers, and the general public, to raise awareness of the burden of COPD and to develop programs for early detection, prevention and approaches to management.
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report is revised annually and is used widely throughout the world as a tool for implementing effective management.
Among the updates in the 2023 GOLD Report, the section on diagnostic criteria added a proposed new category “PRISm,” denoting “preserved ratio impaired spirometry,” encompassing individuals who present with structural lung lesions (for example, emphysema) and/or other physiological abnormalities such as low-normal forced expiratory volume in 1 second (FEV1), gas trapping, hyperinflation, reduced lung diffusing capacity and/or rapid FEV1 decline, but without airflow obstruction (FEV1/FEV ≥ 0.7 post bronchodilation). Some of these “pre-COPD” (chronic obstructive pulmonary disease) individuals, who have a normal ratio but abnormal spirometry are at risk over time of developing airflow obstruction. The best treatment for them, beyond smoking cessation, needs to be determined through research, the report states.
Clinical updates
The GOLD 2023 Report also offers proposed clinical guidance, in the absence of high-quality clinical trial evidence, on initial pharmacologic management of COPD. The proposal is based on individual assessment of symptoms and exacerbation risk following use of the ABE Assessment Tool, a revised version of the ABCD Assessment Tool that recognizes the clinical relevance of exacerbations independent of symptom level.
These updates to information and figures pertaining to initial pharmacological treatment and follow-up pharmacological treatment revise the positioning of LABA (long-acting beta2 agonists) plus LAMA (long-acting muscarinic agonists) and LABA/ICS (inhaled corticosteroids). Among GOLD group A patients with 0 or 1 moderate exacerbations that do not lead to hospital admission, a bronchodilator is recommended.
The recommendation for group B patients is LABA/LAMA with the caveat that single inhaler therapy may be more convenient and effective than multiple inhalers. For group E patients with two or more moderate exacerbations or one or more leading to hospitalization, LABA/LAMA is recommended (with the same inhaler therapy caveat). With blood eosinophil levels at 300 or higher, LABA/LAMA/ICS may be considered.
Commenting on the combination recommendations in a press release, Antonio Anzueto, MD, professor of medicine, pulmonary critical care, University of Texas Health, San Antonio, stated: “From a physician’s perspective, we are always grateful to receive well-vetted and informed recommendations on how we can best utilize available treatment options to provide the most benefit to our patients. The new 2023 GOLD recommendations represent a meaningful change for the treatment of COPD by prioritizing the utilization of a fixed LAMA/LABA combination.”
More interventions
In a section on therapeutic interventions to reduce COPD mortality, the report lists studies showing mortality benefits for fixed-dose inhaled triple combinations (LABA + LAMA + ICS) versus dual inhaled long-acting bronchodilations, and for smoking cessation and pulmonary rehabilitation.
Also new is a strong emphasis on inhaler choice, education, and technique training with assessment of inhaler technique and adherence urged as a prerequisite to judging whether current therapy as insufficient. The report summarizes principles guiding inhaler type selection.
The report also added a section on chronic bronchitis, defining it as a common but variable condition in COPD patients with cough and expectorated sputum on a regular basis over a defined period in the absence of other conditions plausibly causing symptoms.
The fact that chronic bronchitis is sometimes found in never-smokers suggests the involvement of other factors such as exposure to inhaled dusts, biomass fuels, chemical fumes, or domestic heating and cooking fuels, according to the report. Gastroesophageal reflux may also be associated with chronic bronchitis.
The report discusses various taxonomic terms for different types of COPD, such as COPD-G for genetically determined COPD, COPD-D for those with abnormal lung development, and COPD-C for COPD associated with cigarette smoking, etc.
Change in exacerbations
The report also revises the definition of a COPD exacerbation as “an event characterized by increased dyspnea and/or cough and sputum that worsens in less than 14 days which may be accompanied by tachypnea and/or tachycardia and is often associated with increased local and system inflammation caused by infection, pollution, or other insult to the airways.” To overcome limitations conferred by the current grading of COPD exacerbations, the 2023 report proposes a four-step point-of-contact diagnosis and assessment tool.
Telemedicine
Given the constraints brought on by COVID-19 on top of the generally sparse availability of programs and facilities for delivering well-proven pulmonary rehabilitation methods, tele-rehabilitation has been proposed as an alternative to traditional approaches. While the evidence base is still evolving and best practices have not yet been established, the GOLD Report calls for better understanding of barriers to tele-rehabilitation success.
Comorbidities update
The GOLD Report chapter on COPD and comorbidities was also updated, and lists cardiovascular disease, lung cancer, osteoporosis, depression/anxiety, and gastroesophageal reflux disease as common comorbid conditions which may affect prognosis and, in the case of cancer, mortality. The report urges simplicity of treatment to minimize polypharmacy. While annual low-dose CT is recommended for COPD caused by smoking, it is not recommended for COPD caused by smoking; data are insufficient to establish benefit over harm.
While the GOLD Report “COVID-19 and COPD” chapter summarizes current evidence stating that individuals with COPD do not seem to be at substantially greater risk of infection with SARS-CoV-2, it underscores that they are at higher risk of hospitalization for COVID-19 and may be at higher risk for developing severe disease and death.
Many other topics are included in the updated report, among them screening, imaging, vaccinations, adherence to therapy, and surgical and bronchoscopic interventions. In its closing section, the GOLD Report 2023 reiterates its mission, stating: “The GOLD initiative will continue to work with National Leaders and other interested health care professionals to bring COPD to the attention of governments, public health officials, health care workers, and the general public, to raise awareness of the burden of COPD and to develop programs for early detection, prevention and approaches to management.
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report is revised annually and is used widely throughout the world as a tool for implementing effective management.
Among the updates in the 2023 GOLD Report, the section on diagnostic criteria added a proposed new category “PRISm,” denoting “preserved ratio impaired spirometry,” encompassing individuals who present with structural lung lesions (for example, emphysema) and/or other physiological abnormalities such as low-normal forced expiratory volume in 1 second (FEV1), gas trapping, hyperinflation, reduced lung diffusing capacity and/or rapid FEV1 decline, but without airflow obstruction (FEV1/FEV ≥ 0.7 post bronchodilation). Some of these “pre-COPD” (chronic obstructive pulmonary disease) individuals, who have a normal ratio but abnormal spirometry are at risk over time of developing airflow obstruction. The best treatment for them, beyond smoking cessation, needs to be determined through research, the report states.
Clinical updates
The GOLD 2023 Report also offers proposed clinical guidance, in the absence of high-quality clinical trial evidence, on initial pharmacologic management of COPD. The proposal is based on individual assessment of symptoms and exacerbation risk following use of the ABE Assessment Tool, a revised version of the ABCD Assessment Tool that recognizes the clinical relevance of exacerbations independent of symptom level.
These updates to information and figures pertaining to initial pharmacological treatment and follow-up pharmacological treatment revise the positioning of LABA (long-acting beta2 agonists) plus LAMA (long-acting muscarinic agonists) and LABA/ICS (inhaled corticosteroids). Among GOLD group A patients with 0 or 1 moderate exacerbations that do not lead to hospital admission, a bronchodilator is recommended.
The recommendation for group B patients is LABA/LAMA with the caveat that single inhaler therapy may be more convenient and effective than multiple inhalers. For group E patients with two or more moderate exacerbations or one or more leading to hospitalization, LABA/LAMA is recommended (with the same inhaler therapy caveat). With blood eosinophil levels at 300 or higher, LABA/LAMA/ICS may be considered.
Commenting on the combination recommendations in a press release, Antonio Anzueto, MD, professor of medicine, pulmonary critical care, University of Texas Health, San Antonio, stated: “From a physician’s perspective, we are always grateful to receive well-vetted and informed recommendations on how we can best utilize available treatment options to provide the most benefit to our patients. The new 2023 GOLD recommendations represent a meaningful change for the treatment of COPD by prioritizing the utilization of a fixed LAMA/LABA combination.”
More interventions
In a section on therapeutic interventions to reduce COPD mortality, the report lists studies showing mortality benefits for fixed-dose inhaled triple combinations (LABA + LAMA + ICS) versus dual inhaled long-acting bronchodilations, and for smoking cessation and pulmonary rehabilitation.
Also new is a strong emphasis on inhaler choice, education, and technique training with assessment of inhaler technique and adherence urged as a prerequisite to judging whether current therapy as insufficient. The report summarizes principles guiding inhaler type selection.
The report also added a section on chronic bronchitis, defining it as a common but variable condition in COPD patients with cough and expectorated sputum on a regular basis over a defined period in the absence of other conditions plausibly causing symptoms.
The fact that chronic bronchitis is sometimes found in never-smokers suggests the involvement of other factors such as exposure to inhaled dusts, biomass fuels, chemical fumes, or domestic heating and cooking fuels, according to the report. Gastroesophageal reflux may also be associated with chronic bronchitis.
The report discusses various taxonomic terms for different types of COPD, such as COPD-G for genetically determined COPD, COPD-D for those with abnormal lung development, and COPD-C for COPD associated with cigarette smoking, etc.
Change in exacerbations
The report also revises the definition of a COPD exacerbation as “an event characterized by increased dyspnea and/or cough and sputum that worsens in less than 14 days which may be accompanied by tachypnea and/or tachycardia and is often associated with increased local and system inflammation caused by infection, pollution, or other insult to the airways.” To overcome limitations conferred by the current grading of COPD exacerbations, the 2023 report proposes a four-step point-of-contact diagnosis and assessment tool.
Telemedicine
Given the constraints brought on by COVID-19 on top of the generally sparse availability of programs and facilities for delivering well-proven pulmonary rehabilitation methods, tele-rehabilitation has been proposed as an alternative to traditional approaches. While the evidence base is still evolving and best practices have not yet been established, the GOLD Report calls for better understanding of barriers to tele-rehabilitation success.
Comorbidities update
The GOLD Report chapter on COPD and comorbidities was also updated, and lists cardiovascular disease, lung cancer, osteoporosis, depression/anxiety, and gastroesophageal reflux disease as common comorbid conditions which may affect prognosis and, in the case of cancer, mortality. The report urges simplicity of treatment to minimize polypharmacy. While annual low-dose CT is recommended for COPD caused by smoking, it is not recommended for COPD caused by smoking; data are insufficient to establish benefit over harm.
While the GOLD Report “COVID-19 and COPD” chapter summarizes current evidence stating that individuals with COPD do not seem to be at substantially greater risk of infection with SARS-CoV-2, it underscores that they are at higher risk of hospitalization for COVID-19 and may be at higher risk for developing severe disease and death.
Many other topics are included in the updated report, among them screening, imaging, vaccinations, adherence to therapy, and surgical and bronchoscopic interventions. In its closing section, the GOLD Report 2023 reiterates its mission, stating: “The GOLD initiative will continue to work with National Leaders and other interested health care professionals to bring COPD to the attention of governments, public health officials, health care workers, and the general public, to raise awareness of the burden of COPD and to develop programs for early detection, prevention and approaches to management.
Employers use patient assistance programs to offset their own costs
Anna Sutton was shocked when she received a letter from her husband’s job-based health plan stating that Humira, an expensive drug used to treat her daughter’s juvenile arthritis, was now on a long list of medications considered “nonessential benefits.”
The July 2021 letter said the family could either participate in a new effort overseen by a company called SaveOnSP and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.
“It really gave us no choice,” said Mrs. Sutton, of Woodinville, Wash. She added that “every single [Food and Drug Administration]–approved medication for juvenile arthritis” was on the list of nonessential benefits.
Mrs. Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.
Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.
Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers’ spending on insurance – which, they say, could be the difference between an employer offering coverage to workers or not.
It’s the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.
Patient advocates say the term “nonessential” stresses patients out even though it doesn’t mean the drugs – often called “specialty” drugs because of their high prices or the way they are made – are unnecessary.
Some advocates fear the new strategies could be “a way to weed out those with costly health care needs,” said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs.
Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers’ pharmacy benefit managers, such as Express Scripts/Cigna, to implement the strategy. There are also smaller vendors, like SHARx and Payer Matrix, some of which work directly with employers.
In one approach, insurers or employers continue to cover the drugs but designate them as “nonessential,” which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort. Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a lawsuit filed in May by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, N.Y.
The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.
In the other approach, employers don’t bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.
“We’re seeing it in every state at this point,” said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Ill., a federally funded hemophilia treatment center.
The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.
Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed – and sometimes unexpected bills for consumers.
“We have patients get billed after they max out their assistance,” said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error.
Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tenn., whose clientele includes employers that use variations of these programs.
Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug’s cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient’s out-of-pocket costs were capped at lower amounts.
Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.
If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mr. Mann said. Patient groups noted that some specialty drugs may not have any alternatives.
How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.
“Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can’t meet the copay,” said Harry Sandick, a lawyer representing J&J.
J&J’s lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are “coerced” into participating in copay assistance programs after their drugs are deemed “nonessential” and therefore are “no longer subject to the ACA’s annual out-of-pocket maximum.”
Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts.
None of that money counts toward patients’ deductibles or out-of-pocket maximums for the year.
In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such “alternative funding programs.”
Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be “underinsured” so they won’t be affected by the foundation’s decision.
In a statement, SaveOnSP said that employers object to drug companies’ “using their employees’ ongoing need for these drugs as an excuse to keep hiking the drugs’ prices” and that the firm simply “advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees.”
In a court filing, SaveOnSP said drugmakers have another option if they don’t like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.
For Mrs. Sutton’s part, her family did participate in the program offered through her husband’s work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.
So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.
Even so, “the whole process seems kind of slimy to me,” she said. “The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Anna Sutton was shocked when she received a letter from her husband’s job-based health plan stating that Humira, an expensive drug used to treat her daughter’s juvenile arthritis, was now on a long list of medications considered “nonessential benefits.”
The July 2021 letter said the family could either participate in a new effort overseen by a company called SaveOnSP and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.
“It really gave us no choice,” said Mrs. Sutton, of Woodinville, Wash. She added that “every single [Food and Drug Administration]–approved medication for juvenile arthritis” was on the list of nonessential benefits.
Mrs. Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.
Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.
Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers’ spending on insurance – which, they say, could be the difference between an employer offering coverage to workers or not.
It’s the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.
Patient advocates say the term “nonessential” stresses patients out even though it doesn’t mean the drugs – often called “specialty” drugs because of their high prices or the way they are made – are unnecessary.
Some advocates fear the new strategies could be “a way to weed out those with costly health care needs,” said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs.
Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers’ pharmacy benefit managers, such as Express Scripts/Cigna, to implement the strategy. There are also smaller vendors, like SHARx and Payer Matrix, some of which work directly with employers.
In one approach, insurers or employers continue to cover the drugs but designate them as “nonessential,” which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort. Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a lawsuit filed in May by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, N.Y.
The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.
In the other approach, employers don’t bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.
“We’re seeing it in every state at this point,” said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Ill., a federally funded hemophilia treatment center.
The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.
Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed – and sometimes unexpected bills for consumers.
“We have patients get billed after they max out their assistance,” said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error.
Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tenn., whose clientele includes employers that use variations of these programs.
Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug’s cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient’s out-of-pocket costs were capped at lower amounts.
Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.
If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mr. Mann said. Patient groups noted that some specialty drugs may not have any alternatives.
How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.
“Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can’t meet the copay,” said Harry Sandick, a lawyer representing J&J.
J&J’s lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are “coerced” into participating in copay assistance programs after their drugs are deemed “nonessential” and therefore are “no longer subject to the ACA’s annual out-of-pocket maximum.”
Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts.
None of that money counts toward patients’ deductibles or out-of-pocket maximums for the year.
In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such “alternative funding programs.”
Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be “underinsured” so they won’t be affected by the foundation’s decision.
In a statement, SaveOnSP said that employers object to drug companies’ “using their employees’ ongoing need for these drugs as an excuse to keep hiking the drugs’ prices” and that the firm simply “advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees.”
In a court filing, SaveOnSP said drugmakers have another option if they don’t like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.
For Mrs. Sutton’s part, her family did participate in the program offered through her husband’s work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.
So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.
Even so, “the whole process seems kind of slimy to me,” she said. “The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Anna Sutton was shocked when she received a letter from her husband’s job-based health plan stating that Humira, an expensive drug used to treat her daughter’s juvenile arthritis, was now on a long list of medications considered “nonessential benefits.”
The July 2021 letter said the family could either participate in a new effort overseen by a company called SaveOnSP and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.
“It really gave us no choice,” said Mrs. Sutton, of Woodinville, Wash. She added that “every single [Food and Drug Administration]–approved medication for juvenile arthritis” was on the list of nonessential benefits.
Mrs. Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.
Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.
Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers’ spending on insurance – which, they say, could be the difference between an employer offering coverage to workers or not.
It’s the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.
Patient advocates say the term “nonessential” stresses patients out even though it doesn’t mean the drugs – often called “specialty” drugs because of their high prices or the way they are made – are unnecessary.
Some advocates fear the new strategies could be “a way to weed out those with costly health care needs,” said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs.
Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers’ pharmacy benefit managers, such as Express Scripts/Cigna, to implement the strategy. There are also smaller vendors, like SHARx and Payer Matrix, some of which work directly with employers.
In one approach, insurers or employers continue to cover the drugs but designate them as “nonessential,” which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort. Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a lawsuit filed in May by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, N.Y.
The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.
In the other approach, employers don’t bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.
“We’re seeing it in every state at this point,” said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Ill., a federally funded hemophilia treatment center.
The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.
Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed – and sometimes unexpected bills for consumers.
“We have patients get billed after they max out their assistance,” said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error.
Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tenn., whose clientele includes employers that use variations of these programs.
Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug’s cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient’s out-of-pocket costs were capped at lower amounts.
Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.
If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mr. Mann said. Patient groups noted that some specialty drugs may not have any alternatives.
How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.
“Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can’t meet the copay,” said Harry Sandick, a lawyer representing J&J.
J&J’s lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are “coerced” into participating in copay assistance programs after their drugs are deemed “nonessential” and therefore are “no longer subject to the ACA’s annual out-of-pocket maximum.”
Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts.
None of that money counts toward patients’ deductibles or out-of-pocket maximums for the year.
In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such “alternative funding programs.”
Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be “underinsured” so they won’t be affected by the foundation’s decision.
In a statement, SaveOnSP said that employers object to drug companies’ “using their employees’ ongoing need for these drugs as an excuse to keep hiking the drugs’ prices” and that the firm simply “advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees.”
In a court filing, SaveOnSP said drugmakers have another option if they don’t like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.
For Mrs. Sutton’s part, her family did participate in the program offered through her husband’s work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.
So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.
Even so, “the whole process seems kind of slimy to me,” she said. “The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Joint replacements: Should there be BMI cutoffs?
For patients with severe arthritis, joint replacement is considered when more conservative treatments have failed. Because patients with obesity have a higher risk of complications during and after surgery, some surgeons, hospitals, and insurance companies have adopted body mass index cutoffs as a basis for deciding whether to offer patients these elective surgeries. But some experts argue that these cutoffs are arbitrary, exclude patients who can still benefit from the surgery, and can increase disparities in care.
“By enforcing cutoffs in general, you’re losing the ability for each surgeon to determine who they want to operate on,” said Daniel Wiznia, MD, assistant professor of orthopedic surgery at Yale University, New Haven, Conn. He is on the leadership committee of the Movement Is Life Caucus, a nonprofit group focused on eliminating disparities in musculoskeletal health. “For every surgeon, it’s up to them to decide if they feel comfortable doing the surgery,” he noted in an interview. “My guidance for that would be, don’t just say no because of the number – look at the patient’s entire medical profile.”
According to the Centers for Disease Control and Prevention, nearly 42% of adults in the United States have a BMI over 30, and 9.2% of adults have a BMI over 40. This excess weight puts additional stress on joints: When a person is walking, experts estimate that the force on the knees can be two to three times someone’s body weight. Over time, this pressure can wear down the cartilage on joints.
As a result, people who are overweight or obese are more likely to develop osteoarthritis and to need joint replacements. According to a Canadian study, patients with a BMI of 30-35 are 3.4 times as likely to require a hip replacement and are 8.5 times as likely to require a knee replacement compared to individuals with a BMI in the “healthy weight” range. With a BMI above 40, individuals were 8.5 times more likely to need a hip replacement and were 32.7 times as likely to need a knee replacement.
More complications, greater expense
While there are no universally recommended BMI cutoffs for joint replacement surgery, it is not uncommon for institutions to require that patients have a BMI below a certain value (usually 35-40) to proceed with surgery. A 2013 survey of physicians from the American Association of Hip and Knee Surgeons found that 52% of surgeons required a BMI below 40 to qualify for surgery.
One of the main reasons for these cutoffs is the elevated risk of complications during and after surgery. Research suggests that obesity is associated with higher rates of wound dehiscence, prosthetic joint infection (PJI), and revision total joint arthroplasty. One 2016 study suggests that patients with a BMI of 35-39.9 are twice as likely to experience PJI compared to patients with a BMI below 35. For patients with a BMI of 40 or higher, PJI is four times as likely.
Another study found that patients whose BMI is 35-40 and who undergo total joint arthroplasty have a 6.4-fold greater risk of deep incision infection. For those with a BMI over 40, that rises to a 12.9-fold increased risk compared to patients with a BMI of 18.5-25. Patients with obesity tend to have other comorbidities that can increase the risk of complications during surgery, such as type 2 diabetes, coronary artery disease, and chronic kidney disease.
Because of the increased risk of complications, health care costs tend to be higher for patients with obesity. The growing popularity of bundled health payments can discourage operating on patients who are more likely to experience complications, such as patients with high BMIs, noted Dr. Wiznia.
Research suggests that minorities and people with lower socioeconomic status are disproportionately affected by these cutoffs. According to the CDC, among non-Hispanic Black Americans and Hispanic Americans, rates of obesity are higher than among their White counterparts, and these patients are less likely to undergo joint replacement. Strictly enforcing this eligibility criterion can worsen those disparities. A study involving 21,294 adults over age 50 from the National Health and Nutrition Examination Survey (NHANES) found that requiring a BMI of under 35 for total joint arthroplasty resulted in Black patients being 39% less likely to be eligible for surgery than White patients. And individuals with an annual household income under $45,000 were 19% less likely to qualify for surgery than those with a household income above $45,000.
BMI no better than other risk factors
Although high BMI is independently associated with a higher risk of complications, the increased risk of complications conferred by a BMI at or above 40 is similar to or lower than those of other comorbidities that surgeons generally accept, said Nicholas Giori, MD, PhD, professor of orthopedic surgery at Stanford (Calif.) University, and chief of orthopedic surgery at the VA Palo Alto Health Care System. These other comorbidities include age older than 75, hypertension that requires medication, and insulin-controlled diabetes. “The independent risk of just having the diagnosis of insulin-dependent diabetes is actually comparable to the independent risk of having obesity by itself,” he told this news organization, “and all of us operate on [patients with] diabetes.”
Also, there is no BMI at which the risk of complications suddenly increases, according to the American Academy of Orthopaedic Surgeons. “It’s a rising complication rate as you go into higher BMIs,” Dr. Giori said. “If you operate on someone with a BMI of 39 vs. 41, you’re not going to find that much of a difference [in risk].” But if a medical system enforced a hard BMI cutoff of 40, one patient would qualify for surgery while the other would be barred.
Weight not as “modifiable” as previously thought
Weight is often considered a “modifiable factor” for a person considering undergoing total joint arthroplasty, but research suggests that the issue is more complicated. “Obesity is tricky, because some people are successful [in weight loss],” said Dr. Giori. Those tend to be the more memorable stories. “But a large majority have a really hard time losing substantial weight – enough to make a difference in risk,” he continued.
A study conducted in North Carolina found that restricting patients with a BMI over 40 from having elective total joint arthroplasty procedures until their weight was optimized did not result in successful weight loss. Only 20% of patients who originally presented with a BMI above this limit eventually underwent surgery after 2 years, and fewer than half of these patients had achieved a BMI of less than 40 at the time of their surgery. A third of all patients in the study did not return to the orthopedic office after their first visit.
“To hold a hard cutoff when it’s very, very hard to modify ... is essentially telling people that they are not going to ever have surgery,” Dr. Giori said; “I think that can be unfair to some patients.”
Bariatric surgery is often suggested for patients with obesity who have not experienced successful weight loss with diet and lifestyle changes alone, but bariatric surgery comes with its own complications. Research on outcomes from total joint arthroplasty among patients with who have lost weight with bariatric surgery has yielded mixed results. “I rarely push anyone hard to go that route but present it as an option for certain patients,” said Benjamin M. Stronach, MD, an orthopedic surgeon at the University of Arkansas for Medical Sciences, in Little Rock. He usually brings up bariatric surgery with patients with a BMI in the high 40s or higher to gauge their interest. If patients are already considering weight loss surgery, his office provides referrals.
But even bariatric surgery does not result in successful long-term weight loss for every patient, Dr. Stronach said. He’s seeing more and more patients who come for consultations after having undergone bariatric surgery 10 to 15 years ago. These patients lost a significant amount of weight, but then gained the weight back. He noted that bariatric surgery can be very successful for some patients who adhere to their postbariatric regimen. “We typically see fairly impressive results in the short term,” he said.
Patients with obesity benefit from joint replacement
Although patients with obesity are at higher risk for complications from joint replacement surgery, research suggests that these patients can still benefit greatly from these surgeries and that these surgeries remain cost-effective. Some studies have found that patients with obesity tend to have worse outcomes after surgery than patients who are not obese, but often, patients with high BMIs are starting from a lower point, with greater joint pain and limited mobility, Dr. Giori said. But the improvements – that is, net change in measured outcomes – can be greater for obese patients.
“Several studies have shown equal or greater improvements in validated outcome scores, function, and satisfaction compared with nonobese patients after surgery,” authors wrote in a recent review article in which they discuss how to optimize joint replacement surgery for patients with obesity. The article, published in the November 2022 issue of the Journal of the American Academy of Orthopaedic Surgeon (JAAOS), is part of a collection of review articles by the Movement Is Life Caucus.
Encourage weight loss, but look beyond the number
Rather than adhering to strict BMI cutoffs, some experts urge surgeons to consider the patient as a whole and to evaluate each individual’s overall health and potential risk. Dr. Giori generally considers high BMI as just another comorbidity when assessing a patient’s overall risk. “For a person who only has a high BMI but is otherwise healthy, I see no reason not to go ahead and schedule that person for surgery, because reducing the patient’s BMI will not substantially reduce the patient’s complication risk, and a delay in surgery may adversely affect the patient’s quality of life and ability to earn a living,” he said.
“If someone is between a BMI of 40 and 45, we are definitely going to have a discussion about weight,” Dr. Stronach said. He generally counsels against surgery for any patient with a BMI at 45 or above. He wants patients to have a BMI below 40 before surgery but considers individual cases for exceptions. “We will still move forward at times with someone with a BMI of 41, as an example, who is otherwise healthy,” he said. Similarly, if a patient has lost a significant amount of weight (e.g., the patient’s BMI was reduced from 50 to 41), the patient is actively engaged in improving their health, and surgeons believe the patient has significantly reduced their risk, “a lot of time, we’re not going to draw a line in the sand right at [a BMI of] 40,” he said.
While using a BMI of under 35 or 40 as a guideline when starting to work with patients is reasonable, working toward a weight loss of 5%-10% of total body weight is another goal to consider, authors advise in the JAAOS obesity review article. Research suggests that even a 5% reduction in overall body weight can reduce surgical complications and can improve a patient’s glucose and lipid levels and cardiac profile. Referrals to dietitians and weight loss programs, as well as behavioral counseling, can also be useful in initiating weight loss and keeping patients engaged in the process, the authors wrote.
Consider a patient’s comorbidities
Many patients with obesity have comorbidities, such as type 2 diabetes and hypertension, that can also be optimized for surgery so as to lower a patient’s overall risk profile. For patients with diabetes, achieving an A1c of 8% or lower can be a reasonable goal and can reduce risk. “We’ve found that an HbA1c level of 8% or less is something that virtually all diabetics (though not everybody) can reach, and it’s something that can be reached in a reasonable amount of time,” Dr. Giori said. Preoperative use of beta-blockers, continued use of ACE inhibitors or angiotensin receptor blockers, and behavioral modifications can improve a patient’s cardiac health before surgery.
Malnutrition can be a correctable problem for patients, regardless of BMI. In the Movement Is Life collection of optimization articles, experts recommend that orthopedists screen for malnutrition with blood tests for albumin, vitamin D, transferrin, and total lymphocyte count. Patients with malnutrition should be screened for food insecurity, experts advise, and surgical candidates with deficiencies can be given supplements of omega-3 fatty acids, arginine, and protein shakes.
Surgeon comfort and shared decision-making
Dr. Wiznia emphasized that the patient and surgeon need to discuss the risks of surgery, concerns about potential complications, and how a complication could affect the patient’s life moving forward. “Ultimately, the surgeon needs to make the decision [of whether or not to proceed [with surgery] with the patient,” he said, “but not every surgeon is going to feel comfortable operating on these patients, and not every medical institution is going to have the equipment and the investments to support surgeons doing it.”
Dr. Giori agreed that surgeons should proceed only with surgical cases they feel comfortable with. Certain surgeons may decide not to operate on individuals with higher BMIs because of the potential complications and can refer these patients to more specialized care centers. Operating on larger patients is more difficult and requires surgical skills and expertise that the surgeon may not have, he noted. “What I do object to is a system-wide BMI cutoff – for example, if an insurance company won’t pay for you to have a joint replacement, regardless of where you go or who your surgeon is,” Dr. Giori added. “I think that’s wrong, because it’s not patient centered and it’s basically excluding people from having a life-altering operation.”
Dr. Giori and Dr. Wiznia report no relevant financial relationships. Dr. Stronach is a consultant for DJ Orthopaedics, Johnson & Johnson, and MiCare Path.
A version of this article first appeared on Medscape.com.
For patients with severe arthritis, joint replacement is considered when more conservative treatments have failed. Because patients with obesity have a higher risk of complications during and after surgery, some surgeons, hospitals, and insurance companies have adopted body mass index cutoffs as a basis for deciding whether to offer patients these elective surgeries. But some experts argue that these cutoffs are arbitrary, exclude patients who can still benefit from the surgery, and can increase disparities in care.
“By enforcing cutoffs in general, you’re losing the ability for each surgeon to determine who they want to operate on,” said Daniel Wiznia, MD, assistant professor of orthopedic surgery at Yale University, New Haven, Conn. He is on the leadership committee of the Movement Is Life Caucus, a nonprofit group focused on eliminating disparities in musculoskeletal health. “For every surgeon, it’s up to them to decide if they feel comfortable doing the surgery,” he noted in an interview. “My guidance for that would be, don’t just say no because of the number – look at the patient’s entire medical profile.”
According to the Centers for Disease Control and Prevention, nearly 42% of adults in the United States have a BMI over 30, and 9.2% of adults have a BMI over 40. This excess weight puts additional stress on joints: When a person is walking, experts estimate that the force on the knees can be two to three times someone’s body weight. Over time, this pressure can wear down the cartilage on joints.
As a result, people who are overweight or obese are more likely to develop osteoarthritis and to need joint replacements. According to a Canadian study, patients with a BMI of 30-35 are 3.4 times as likely to require a hip replacement and are 8.5 times as likely to require a knee replacement compared to individuals with a BMI in the “healthy weight” range. With a BMI above 40, individuals were 8.5 times more likely to need a hip replacement and were 32.7 times as likely to need a knee replacement.
More complications, greater expense
While there are no universally recommended BMI cutoffs for joint replacement surgery, it is not uncommon for institutions to require that patients have a BMI below a certain value (usually 35-40) to proceed with surgery. A 2013 survey of physicians from the American Association of Hip and Knee Surgeons found that 52% of surgeons required a BMI below 40 to qualify for surgery.
One of the main reasons for these cutoffs is the elevated risk of complications during and after surgery. Research suggests that obesity is associated with higher rates of wound dehiscence, prosthetic joint infection (PJI), and revision total joint arthroplasty. One 2016 study suggests that patients with a BMI of 35-39.9 are twice as likely to experience PJI compared to patients with a BMI below 35. For patients with a BMI of 40 or higher, PJI is four times as likely.
Another study found that patients whose BMI is 35-40 and who undergo total joint arthroplasty have a 6.4-fold greater risk of deep incision infection. For those with a BMI over 40, that rises to a 12.9-fold increased risk compared to patients with a BMI of 18.5-25. Patients with obesity tend to have other comorbidities that can increase the risk of complications during surgery, such as type 2 diabetes, coronary artery disease, and chronic kidney disease.
Because of the increased risk of complications, health care costs tend to be higher for patients with obesity. The growing popularity of bundled health payments can discourage operating on patients who are more likely to experience complications, such as patients with high BMIs, noted Dr. Wiznia.
Research suggests that minorities and people with lower socioeconomic status are disproportionately affected by these cutoffs. According to the CDC, among non-Hispanic Black Americans and Hispanic Americans, rates of obesity are higher than among their White counterparts, and these patients are less likely to undergo joint replacement. Strictly enforcing this eligibility criterion can worsen those disparities. A study involving 21,294 adults over age 50 from the National Health and Nutrition Examination Survey (NHANES) found that requiring a BMI of under 35 for total joint arthroplasty resulted in Black patients being 39% less likely to be eligible for surgery than White patients. And individuals with an annual household income under $45,000 were 19% less likely to qualify for surgery than those with a household income above $45,000.
BMI no better than other risk factors
Although high BMI is independently associated with a higher risk of complications, the increased risk of complications conferred by a BMI at or above 40 is similar to or lower than those of other comorbidities that surgeons generally accept, said Nicholas Giori, MD, PhD, professor of orthopedic surgery at Stanford (Calif.) University, and chief of orthopedic surgery at the VA Palo Alto Health Care System. These other comorbidities include age older than 75, hypertension that requires medication, and insulin-controlled diabetes. “The independent risk of just having the diagnosis of insulin-dependent diabetes is actually comparable to the independent risk of having obesity by itself,” he told this news organization, “and all of us operate on [patients with] diabetes.”
Also, there is no BMI at which the risk of complications suddenly increases, according to the American Academy of Orthopaedic Surgeons. “It’s a rising complication rate as you go into higher BMIs,” Dr. Giori said. “If you operate on someone with a BMI of 39 vs. 41, you’re not going to find that much of a difference [in risk].” But if a medical system enforced a hard BMI cutoff of 40, one patient would qualify for surgery while the other would be barred.
Weight not as “modifiable” as previously thought
Weight is often considered a “modifiable factor” for a person considering undergoing total joint arthroplasty, but research suggests that the issue is more complicated. “Obesity is tricky, because some people are successful [in weight loss],” said Dr. Giori. Those tend to be the more memorable stories. “But a large majority have a really hard time losing substantial weight – enough to make a difference in risk,” he continued.
A study conducted in North Carolina found that restricting patients with a BMI over 40 from having elective total joint arthroplasty procedures until their weight was optimized did not result in successful weight loss. Only 20% of patients who originally presented with a BMI above this limit eventually underwent surgery after 2 years, and fewer than half of these patients had achieved a BMI of less than 40 at the time of their surgery. A third of all patients in the study did not return to the orthopedic office after their first visit.
“To hold a hard cutoff when it’s very, very hard to modify ... is essentially telling people that they are not going to ever have surgery,” Dr. Giori said; “I think that can be unfair to some patients.”
Bariatric surgery is often suggested for patients with obesity who have not experienced successful weight loss with diet and lifestyle changes alone, but bariatric surgery comes with its own complications. Research on outcomes from total joint arthroplasty among patients with who have lost weight with bariatric surgery has yielded mixed results. “I rarely push anyone hard to go that route but present it as an option for certain patients,” said Benjamin M. Stronach, MD, an orthopedic surgeon at the University of Arkansas for Medical Sciences, in Little Rock. He usually brings up bariatric surgery with patients with a BMI in the high 40s or higher to gauge their interest. If patients are already considering weight loss surgery, his office provides referrals.
But even bariatric surgery does not result in successful long-term weight loss for every patient, Dr. Stronach said. He’s seeing more and more patients who come for consultations after having undergone bariatric surgery 10 to 15 years ago. These patients lost a significant amount of weight, but then gained the weight back. He noted that bariatric surgery can be very successful for some patients who adhere to their postbariatric regimen. “We typically see fairly impressive results in the short term,” he said.
Patients with obesity benefit from joint replacement
Although patients with obesity are at higher risk for complications from joint replacement surgery, research suggests that these patients can still benefit greatly from these surgeries and that these surgeries remain cost-effective. Some studies have found that patients with obesity tend to have worse outcomes after surgery than patients who are not obese, but often, patients with high BMIs are starting from a lower point, with greater joint pain and limited mobility, Dr. Giori said. But the improvements – that is, net change in measured outcomes – can be greater for obese patients.
“Several studies have shown equal or greater improvements in validated outcome scores, function, and satisfaction compared with nonobese patients after surgery,” authors wrote in a recent review article in which they discuss how to optimize joint replacement surgery for patients with obesity. The article, published in the November 2022 issue of the Journal of the American Academy of Orthopaedic Surgeon (JAAOS), is part of a collection of review articles by the Movement Is Life Caucus.
Encourage weight loss, but look beyond the number
Rather than adhering to strict BMI cutoffs, some experts urge surgeons to consider the patient as a whole and to evaluate each individual’s overall health and potential risk. Dr. Giori generally considers high BMI as just another comorbidity when assessing a patient’s overall risk. “For a person who only has a high BMI but is otherwise healthy, I see no reason not to go ahead and schedule that person for surgery, because reducing the patient’s BMI will not substantially reduce the patient’s complication risk, and a delay in surgery may adversely affect the patient’s quality of life and ability to earn a living,” he said.
“If someone is between a BMI of 40 and 45, we are definitely going to have a discussion about weight,” Dr. Stronach said. He generally counsels against surgery for any patient with a BMI at 45 or above. He wants patients to have a BMI below 40 before surgery but considers individual cases for exceptions. “We will still move forward at times with someone with a BMI of 41, as an example, who is otherwise healthy,” he said. Similarly, if a patient has lost a significant amount of weight (e.g., the patient’s BMI was reduced from 50 to 41), the patient is actively engaged in improving their health, and surgeons believe the patient has significantly reduced their risk, “a lot of time, we’re not going to draw a line in the sand right at [a BMI of] 40,” he said.
While using a BMI of under 35 or 40 as a guideline when starting to work with patients is reasonable, working toward a weight loss of 5%-10% of total body weight is another goal to consider, authors advise in the JAAOS obesity review article. Research suggests that even a 5% reduction in overall body weight can reduce surgical complications and can improve a patient’s glucose and lipid levels and cardiac profile. Referrals to dietitians and weight loss programs, as well as behavioral counseling, can also be useful in initiating weight loss and keeping patients engaged in the process, the authors wrote.
Consider a patient’s comorbidities
Many patients with obesity have comorbidities, such as type 2 diabetes and hypertension, that can also be optimized for surgery so as to lower a patient’s overall risk profile. For patients with diabetes, achieving an A1c of 8% or lower can be a reasonable goal and can reduce risk. “We’ve found that an HbA1c level of 8% or less is something that virtually all diabetics (though not everybody) can reach, and it’s something that can be reached in a reasonable amount of time,” Dr. Giori said. Preoperative use of beta-blockers, continued use of ACE inhibitors or angiotensin receptor blockers, and behavioral modifications can improve a patient’s cardiac health before surgery.
Malnutrition can be a correctable problem for patients, regardless of BMI. In the Movement Is Life collection of optimization articles, experts recommend that orthopedists screen for malnutrition with blood tests for albumin, vitamin D, transferrin, and total lymphocyte count. Patients with malnutrition should be screened for food insecurity, experts advise, and surgical candidates with deficiencies can be given supplements of omega-3 fatty acids, arginine, and protein shakes.
Surgeon comfort and shared decision-making
Dr. Wiznia emphasized that the patient and surgeon need to discuss the risks of surgery, concerns about potential complications, and how a complication could affect the patient’s life moving forward. “Ultimately, the surgeon needs to make the decision [of whether or not to proceed [with surgery] with the patient,” he said, “but not every surgeon is going to feel comfortable operating on these patients, and not every medical institution is going to have the equipment and the investments to support surgeons doing it.”
Dr. Giori agreed that surgeons should proceed only with surgical cases they feel comfortable with. Certain surgeons may decide not to operate on individuals with higher BMIs because of the potential complications and can refer these patients to more specialized care centers. Operating on larger patients is more difficult and requires surgical skills and expertise that the surgeon may not have, he noted. “What I do object to is a system-wide BMI cutoff – for example, if an insurance company won’t pay for you to have a joint replacement, regardless of where you go or who your surgeon is,” Dr. Giori added. “I think that’s wrong, because it’s not patient centered and it’s basically excluding people from having a life-altering operation.”
Dr. Giori and Dr. Wiznia report no relevant financial relationships. Dr. Stronach is a consultant for DJ Orthopaedics, Johnson & Johnson, and MiCare Path.
A version of this article first appeared on Medscape.com.
For patients with severe arthritis, joint replacement is considered when more conservative treatments have failed. Because patients with obesity have a higher risk of complications during and after surgery, some surgeons, hospitals, and insurance companies have adopted body mass index cutoffs as a basis for deciding whether to offer patients these elective surgeries. But some experts argue that these cutoffs are arbitrary, exclude patients who can still benefit from the surgery, and can increase disparities in care.
“By enforcing cutoffs in general, you’re losing the ability for each surgeon to determine who they want to operate on,” said Daniel Wiznia, MD, assistant professor of orthopedic surgery at Yale University, New Haven, Conn. He is on the leadership committee of the Movement Is Life Caucus, a nonprofit group focused on eliminating disparities in musculoskeletal health. “For every surgeon, it’s up to them to decide if they feel comfortable doing the surgery,” he noted in an interview. “My guidance for that would be, don’t just say no because of the number – look at the patient’s entire medical profile.”
According to the Centers for Disease Control and Prevention, nearly 42% of adults in the United States have a BMI over 30, and 9.2% of adults have a BMI over 40. This excess weight puts additional stress on joints: When a person is walking, experts estimate that the force on the knees can be two to three times someone’s body weight. Over time, this pressure can wear down the cartilage on joints.
As a result, people who are overweight or obese are more likely to develop osteoarthritis and to need joint replacements. According to a Canadian study, patients with a BMI of 30-35 are 3.4 times as likely to require a hip replacement and are 8.5 times as likely to require a knee replacement compared to individuals with a BMI in the “healthy weight” range. With a BMI above 40, individuals were 8.5 times more likely to need a hip replacement and were 32.7 times as likely to need a knee replacement.
More complications, greater expense
While there are no universally recommended BMI cutoffs for joint replacement surgery, it is not uncommon for institutions to require that patients have a BMI below a certain value (usually 35-40) to proceed with surgery. A 2013 survey of physicians from the American Association of Hip and Knee Surgeons found that 52% of surgeons required a BMI below 40 to qualify for surgery.
One of the main reasons for these cutoffs is the elevated risk of complications during and after surgery. Research suggests that obesity is associated with higher rates of wound dehiscence, prosthetic joint infection (PJI), and revision total joint arthroplasty. One 2016 study suggests that patients with a BMI of 35-39.9 are twice as likely to experience PJI compared to patients with a BMI below 35. For patients with a BMI of 40 or higher, PJI is four times as likely.
Another study found that patients whose BMI is 35-40 and who undergo total joint arthroplasty have a 6.4-fold greater risk of deep incision infection. For those with a BMI over 40, that rises to a 12.9-fold increased risk compared to patients with a BMI of 18.5-25. Patients with obesity tend to have other comorbidities that can increase the risk of complications during surgery, such as type 2 diabetes, coronary artery disease, and chronic kidney disease.
Because of the increased risk of complications, health care costs tend to be higher for patients with obesity. The growing popularity of bundled health payments can discourage operating on patients who are more likely to experience complications, such as patients with high BMIs, noted Dr. Wiznia.
Research suggests that minorities and people with lower socioeconomic status are disproportionately affected by these cutoffs. According to the CDC, among non-Hispanic Black Americans and Hispanic Americans, rates of obesity are higher than among their White counterparts, and these patients are less likely to undergo joint replacement. Strictly enforcing this eligibility criterion can worsen those disparities. A study involving 21,294 adults over age 50 from the National Health and Nutrition Examination Survey (NHANES) found that requiring a BMI of under 35 for total joint arthroplasty resulted in Black patients being 39% less likely to be eligible for surgery than White patients. And individuals with an annual household income under $45,000 were 19% less likely to qualify for surgery than those with a household income above $45,000.
BMI no better than other risk factors
Although high BMI is independently associated with a higher risk of complications, the increased risk of complications conferred by a BMI at or above 40 is similar to or lower than those of other comorbidities that surgeons generally accept, said Nicholas Giori, MD, PhD, professor of orthopedic surgery at Stanford (Calif.) University, and chief of orthopedic surgery at the VA Palo Alto Health Care System. These other comorbidities include age older than 75, hypertension that requires medication, and insulin-controlled diabetes. “The independent risk of just having the diagnosis of insulin-dependent diabetes is actually comparable to the independent risk of having obesity by itself,” he told this news organization, “and all of us operate on [patients with] diabetes.”
Also, there is no BMI at which the risk of complications suddenly increases, according to the American Academy of Orthopaedic Surgeons. “It’s a rising complication rate as you go into higher BMIs,” Dr. Giori said. “If you operate on someone with a BMI of 39 vs. 41, you’re not going to find that much of a difference [in risk].” But if a medical system enforced a hard BMI cutoff of 40, one patient would qualify for surgery while the other would be barred.
Weight not as “modifiable” as previously thought
Weight is often considered a “modifiable factor” for a person considering undergoing total joint arthroplasty, but research suggests that the issue is more complicated. “Obesity is tricky, because some people are successful [in weight loss],” said Dr. Giori. Those tend to be the more memorable stories. “But a large majority have a really hard time losing substantial weight – enough to make a difference in risk,” he continued.
A study conducted in North Carolina found that restricting patients with a BMI over 40 from having elective total joint arthroplasty procedures until their weight was optimized did not result in successful weight loss. Only 20% of patients who originally presented with a BMI above this limit eventually underwent surgery after 2 years, and fewer than half of these patients had achieved a BMI of less than 40 at the time of their surgery. A third of all patients in the study did not return to the orthopedic office after their first visit.
“To hold a hard cutoff when it’s very, very hard to modify ... is essentially telling people that they are not going to ever have surgery,” Dr. Giori said; “I think that can be unfair to some patients.”
Bariatric surgery is often suggested for patients with obesity who have not experienced successful weight loss with diet and lifestyle changes alone, but bariatric surgery comes with its own complications. Research on outcomes from total joint arthroplasty among patients with who have lost weight with bariatric surgery has yielded mixed results. “I rarely push anyone hard to go that route but present it as an option for certain patients,” said Benjamin M. Stronach, MD, an orthopedic surgeon at the University of Arkansas for Medical Sciences, in Little Rock. He usually brings up bariatric surgery with patients with a BMI in the high 40s or higher to gauge their interest. If patients are already considering weight loss surgery, his office provides referrals.
But even bariatric surgery does not result in successful long-term weight loss for every patient, Dr. Stronach said. He’s seeing more and more patients who come for consultations after having undergone bariatric surgery 10 to 15 years ago. These patients lost a significant amount of weight, but then gained the weight back. He noted that bariatric surgery can be very successful for some patients who adhere to their postbariatric regimen. “We typically see fairly impressive results in the short term,” he said.
Patients with obesity benefit from joint replacement
Although patients with obesity are at higher risk for complications from joint replacement surgery, research suggests that these patients can still benefit greatly from these surgeries and that these surgeries remain cost-effective. Some studies have found that patients with obesity tend to have worse outcomes after surgery than patients who are not obese, but often, patients with high BMIs are starting from a lower point, with greater joint pain and limited mobility, Dr. Giori said. But the improvements – that is, net change in measured outcomes – can be greater for obese patients.
“Several studies have shown equal or greater improvements in validated outcome scores, function, and satisfaction compared with nonobese patients after surgery,” authors wrote in a recent review article in which they discuss how to optimize joint replacement surgery for patients with obesity. The article, published in the November 2022 issue of the Journal of the American Academy of Orthopaedic Surgeon (JAAOS), is part of a collection of review articles by the Movement Is Life Caucus.
Encourage weight loss, but look beyond the number
Rather than adhering to strict BMI cutoffs, some experts urge surgeons to consider the patient as a whole and to evaluate each individual’s overall health and potential risk. Dr. Giori generally considers high BMI as just another comorbidity when assessing a patient’s overall risk. “For a person who only has a high BMI but is otherwise healthy, I see no reason not to go ahead and schedule that person for surgery, because reducing the patient’s BMI will not substantially reduce the patient’s complication risk, and a delay in surgery may adversely affect the patient’s quality of life and ability to earn a living,” he said.
“If someone is between a BMI of 40 and 45, we are definitely going to have a discussion about weight,” Dr. Stronach said. He generally counsels against surgery for any patient with a BMI at 45 or above. He wants patients to have a BMI below 40 before surgery but considers individual cases for exceptions. “We will still move forward at times with someone with a BMI of 41, as an example, who is otherwise healthy,” he said. Similarly, if a patient has lost a significant amount of weight (e.g., the patient’s BMI was reduced from 50 to 41), the patient is actively engaged in improving their health, and surgeons believe the patient has significantly reduced their risk, “a lot of time, we’re not going to draw a line in the sand right at [a BMI of] 40,” he said.
While using a BMI of under 35 or 40 as a guideline when starting to work with patients is reasonable, working toward a weight loss of 5%-10% of total body weight is another goal to consider, authors advise in the JAAOS obesity review article. Research suggests that even a 5% reduction in overall body weight can reduce surgical complications and can improve a patient’s glucose and lipid levels and cardiac profile. Referrals to dietitians and weight loss programs, as well as behavioral counseling, can also be useful in initiating weight loss and keeping patients engaged in the process, the authors wrote.
Consider a patient’s comorbidities
Many patients with obesity have comorbidities, such as type 2 diabetes and hypertension, that can also be optimized for surgery so as to lower a patient’s overall risk profile. For patients with diabetes, achieving an A1c of 8% or lower can be a reasonable goal and can reduce risk. “We’ve found that an HbA1c level of 8% or less is something that virtually all diabetics (though not everybody) can reach, and it’s something that can be reached in a reasonable amount of time,” Dr. Giori said. Preoperative use of beta-blockers, continued use of ACE inhibitors or angiotensin receptor blockers, and behavioral modifications can improve a patient’s cardiac health before surgery.
Malnutrition can be a correctable problem for patients, regardless of BMI. In the Movement Is Life collection of optimization articles, experts recommend that orthopedists screen for malnutrition with blood tests for albumin, vitamin D, transferrin, and total lymphocyte count. Patients with malnutrition should be screened for food insecurity, experts advise, and surgical candidates with deficiencies can be given supplements of omega-3 fatty acids, arginine, and protein shakes.
Surgeon comfort and shared decision-making
Dr. Wiznia emphasized that the patient and surgeon need to discuss the risks of surgery, concerns about potential complications, and how a complication could affect the patient’s life moving forward. “Ultimately, the surgeon needs to make the decision [of whether or not to proceed [with surgery] with the patient,” he said, “but not every surgeon is going to feel comfortable operating on these patients, and not every medical institution is going to have the equipment and the investments to support surgeons doing it.”
Dr. Giori agreed that surgeons should proceed only with surgical cases they feel comfortable with. Certain surgeons may decide not to operate on individuals with higher BMIs because of the potential complications and can refer these patients to more specialized care centers. Operating on larger patients is more difficult and requires surgical skills and expertise that the surgeon may not have, he noted. “What I do object to is a system-wide BMI cutoff – for example, if an insurance company won’t pay for you to have a joint replacement, regardless of where you go or who your surgeon is,” Dr. Giori added. “I think that’s wrong, because it’s not patient centered and it’s basically excluding people from having a life-altering operation.”
Dr. Giori and Dr. Wiznia report no relevant financial relationships. Dr. Stronach is a consultant for DJ Orthopaedics, Johnson & Johnson, and MiCare Path.
A version of this article first appeared on Medscape.com.
Less than a third of Americans aware of cancer risk from alcohol
The new findings, from a nationally representative survey that included responses from 3,865 adults, show a low awareness of the cancer risk from alcohol, and also that the risk varies by type of drink. Just under a third (31.2%) of respondents thought that consuming liquor/spirits was associated with a risk of cancer, but this fell to 24.9% for drinking beer and even further, to 20.3%, for drinking wine.
In fact, some respondents though the opposite – that drinking alcohol has health benefits; 10.3% of respondents thought that drinking wine was associated with a decreased cancer risk, while 2.25% thought the same for drinking beer, and 1.7% thought that for drinking liquor.
Most U.S. adults (> 50%) reported not knowing how these beverages affected cancer risk, the authors report.
“This study’s findings underscore the need to develop interventions for educating the public about the cancer risks of alcohol use, particularly in the prevailing context of national dialogue about the purported heart health benefits of wine,” commented senior author William M. P. Klein, PhD, associate director of the National Cancer Institute’s Behavioral Research Program, in a statement.
“All types of alcoholic beverages, including wine, increase cancer risk,” Dr. Klein said.
The findings were published online in Cancer Epidemiology, Biomarkers & Prevention.
The results echo the findings of a previous national survey that also found that the majority of Americans are not aware that alcohol consumption is associated with an increased risk of developing a variety of cancers.
In contrast, within the scientific community, there is long-standing and increasing awareness of alcohol consumption as a leading modifiable risk factor for cancer, and there is a growing movement calling for more public health awareness of the link.
Recently, there has been some public support for adding written warnings about the cancer risk from alcohol. A Citizen Petition was filed in 2021, and in August 2022, The New England Journal of Medicine issued a call for new labeling.
Several cancer organizations are petitioning for warnings to be added to alcoholic beverages. The petition is supported by the American Society of Clinical Oncology, the American Institute for Cancer Research, and Breast Cancer Prevention Partners, all in collaboration with several public health organizations. Proposed labeling would read: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”
Dr. Klein and colleagues suggest that public health interventions, including mass media campaigns, cancer warning labels, and patient-provider communications, could help disseminate information about cancer and alcohol. “Educating the public about how alcohol increases cancer risk will not only empower consumers to make more informed decisions but may also prevent and reduce excessive alcohol use, as well as cancer morbidity and mortality,” Dr. Klein said.
The study was supported by the Division of Cancer Control and Population Sciences at the National Cancer Institute. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The new findings, from a nationally representative survey that included responses from 3,865 adults, show a low awareness of the cancer risk from alcohol, and also that the risk varies by type of drink. Just under a third (31.2%) of respondents thought that consuming liquor/spirits was associated with a risk of cancer, but this fell to 24.9% for drinking beer and even further, to 20.3%, for drinking wine.
In fact, some respondents though the opposite – that drinking alcohol has health benefits; 10.3% of respondents thought that drinking wine was associated with a decreased cancer risk, while 2.25% thought the same for drinking beer, and 1.7% thought that for drinking liquor.
Most U.S. adults (> 50%) reported not knowing how these beverages affected cancer risk, the authors report.
“This study’s findings underscore the need to develop interventions for educating the public about the cancer risks of alcohol use, particularly in the prevailing context of national dialogue about the purported heart health benefits of wine,” commented senior author William M. P. Klein, PhD, associate director of the National Cancer Institute’s Behavioral Research Program, in a statement.
“All types of alcoholic beverages, including wine, increase cancer risk,” Dr. Klein said.
The findings were published online in Cancer Epidemiology, Biomarkers & Prevention.
The results echo the findings of a previous national survey that also found that the majority of Americans are not aware that alcohol consumption is associated with an increased risk of developing a variety of cancers.
In contrast, within the scientific community, there is long-standing and increasing awareness of alcohol consumption as a leading modifiable risk factor for cancer, and there is a growing movement calling for more public health awareness of the link.
Recently, there has been some public support for adding written warnings about the cancer risk from alcohol. A Citizen Petition was filed in 2021, and in August 2022, The New England Journal of Medicine issued a call for new labeling.
Several cancer organizations are petitioning for warnings to be added to alcoholic beverages. The petition is supported by the American Society of Clinical Oncology, the American Institute for Cancer Research, and Breast Cancer Prevention Partners, all in collaboration with several public health organizations. Proposed labeling would read: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”
Dr. Klein and colleagues suggest that public health interventions, including mass media campaigns, cancer warning labels, and patient-provider communications, could help disseminate information about cancer and alcohol. “Educating the public about how alcohol increases cancer risk will not only empower consumers to make more informed decisions but may also prevent and reduce excessive alcohol use, as well as cancer morbidity and mortality,” Dr. Klein said.
The study was supported by the Division of Cancer Control and Population Sciences at the National Cancer Institute. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The new findings, from a nationally representative survey that included responses from 3,865 adults, show a low awareness of the cancer risk from alcohol, and also that the risk varies by type of drink. Just under a third (31.2%) of respondents thought that consuming liquor/spirits was associated with a risk of cancer, but this fell to 24.9% for drinking beer and even further, to 20.3%, for drinking wine.
In fact, some respondents though the opposite – that drinking alcohol has health benefits; 10.3% of respondents thought that drinking wine was associated with a decreased cancer risk, while 2.25% thought the same for drinking beer, and 1.7% thought that for drinking liquor.
Most U.S. adults (> 50%) reported not knowing how these beverages affected cancer risk, the authors report.
“This study’s findings underscore the need to develop interventions for educating the public about the cancer risks of alcohol use, particularly in the prevailing context of national dialogue about the purported heart health benefits of wine,” commented senior author William M. P. Klein, PhD, associate director of the National Cancer Institute’s Behavioral Research Program, in a statement.
“All types of alcoholic beverages, including wine, increase cancer risk,” Dr. Klein said.
The findings were published online in Cancer Epidemiology, Biomarkers & Prevention.
The results echo the findings of a previous national survey that also found that the majority of Americans are not aware that alcohol consumption is associated with an increased risk of developing a variety of cancers.
In contrast, within the scientific community, there is long-standing and increasing awareness of alcohol consumption as a leading modifiable risk factor for cancer, and there is a growing movement calling for more public health awareness of the link.
Recently, there has been some public support for adding written warnings about the cancer risk from alcohol. A Citizen Petition was filed in 2021, and in August 2022, The New England Journal of Medicine issued a call for new labeling.
Several cancer organizations are petitioning for warnings to be added to alcoholic beverages. The petition is supported by the American Society of Clinical Oncology, the American Institute for Cancer Research, and Breast Cancer Prevention Partners, all in collaboration with several public health organizations. Proposed labeling would read: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”
Dr. Klein and colleagues suggest that public health interventions, including mass media campaigns, cancer warning labels, and patient-provider communications, could help disseminate information about cancer and alcohol. “Educating the public about how alcohol increases cancer risk will not only empower consumers to make more informed decisions but may also prevent and reduce excessive alcohol use, as well as cancer morbidity and mortality,” Dr. Klein said.
The study was supported by the Division of Cancer Control and Population Sciences at the National Cancer Institute. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CANCER EPIDEMIOLOGY, BIOMARKERS & PREVENTION
Diabetes decision tool yields ‘modest’ benefit in low-resource clinics
a randomized trial in China showed.
The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.
Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.
They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.
Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.
“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
Small improvements
To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.
Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.
The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.
At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.
After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).
The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).
All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
Addressing social needs
Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.
However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.
Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”
On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.
Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”
“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.
Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”
She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
Another team approach
Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.
In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.
Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.
Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.
Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).
Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.
In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.
The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.
a randomized trial in China showed.
The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.
Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.
They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.
Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.
“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
Small improvements
To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.
Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.
The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.
At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.
After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).
The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).
All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
Addressing social needs
Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.
However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.
Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”
On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.
Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”
“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.
Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”
She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
Another team approach
Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.
In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.
Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.
Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.
Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).
Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.
In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.
The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.
a randomized trial in China showed.
The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.
Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.
They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.
Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.
“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
Small improvements
To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.
Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.
The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.
At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.
After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).
The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).
All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
Addressing social needs
Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.
However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.
Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”
On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.
Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”
“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.
Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”
She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
Another team approach
Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.
In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.
Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.
Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.
Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).
Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.
In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.
The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.
FROM ANNALS OF INTERNAL MEDICINE
Have long COVID? Newest booster vaccines may help you
Yet at 58, the Arizona writer is in no hurry to get the latest vaccine booster. “I just don’t want to risk getting any sicker,” she said.
Ms. Dishner has had two doses of vaccine plus two boosters. Each time, she had what regulators consider to be mild reactions, including a sore arm, slight fever, nausea, and body aches. Still, there’s some evidence that the newest booster, which protects against some of the later variants, could help people like Ms. Dishner in several ways, said Ziyad Al-Aly, MD, a clinical epidemiologist and prolific long COVID researcher at Washington University in St. Louis.
“A bivalent booster might actually [help with] your long COVID,” he said.
There may be other benefits. “What vaccines or current vaccine boosters do is reduce your risk of progression to severe COVID-19 illness,” Dr. Al-Aly said. “You are avoiding hospital stays or even worse; you’re avoiding potentially fatal outcomes after infection. And that’s really worth it. Who wants to be in the hospital this Christmas holiday?”
Each time people are infected with SARS-CoV-2, the virus that causes COVID-19, they have a fresh risk of not only getting severely ill or dying, but of developing long COVID, Dr. Al-Aly and colleagues found in a study published in Nature Medicine. “If you dodged the bullet the first time and did not get long COVID after the first infection, if you get reinfected, you’re trying your luck again,” Dr. Al-Aly said. “I would advise people not to get reinfected, which is another reason to get the booster.”
In a recent review in The Lancet eClinicalMedicine, an international team of researchers looked at 11 studies that sought to find out if vaccines affected long COVID symptoms. Seven of those studies found that people’s symptoms improved after they were vaccinated, and four found that symptoms mostly remained the same. One found symptoms got worse in some patients.
A study of 28,000 people published in the British Medical Journal found more evidence that vaccination may help ease symptoms. “Vaccination may contribute to a reduction in the population health burden of long COVID,” the team at the United Kingdom’s Office for National Statistics concluded. Most studies found vaccination reduced the risk of getting long COVID in the first place.
Vaccines prompt the body to produce antibodies, which stop a microbe from infecting cells. They also prompt the production of immune cells called T cells, which continue to hunt down and attack a pathogen even after infection.
A booster dose could help rev up that immune response in a patient with long COVID, said Stephen J. Thomas, MD, an infectious disease specialist at Upstate Medical Center in Syracuse, N.Y., and the center’s lead principal investigator for Pfizer/BioNTech’s COVID-19 2020 vaccine trial.
Some scientists believe long COVID might be caused when the virus persists in parts of the body where the immune system isn’t particularly active. Although they don’t fully understand the workings of the many and varied long COVID symptoms, they have a good idea about why people with long COVID often do better after receiving a vaccine or booster.
“The theory is that by boosting, the immune system may be able to ‘mop up’ those virus stragglers that have remained behind after your first cleanup attempt,” Dr. Thomas said.
“The vaccine is almost lending a hand or helping your immune response to clear that virus,” Dr. Al-Aly said.
It could be difficult for long COVID patients to make an informed decision about boosters, given the lack of studies that focus exclusively on the relationship between long COVID and boosters, according to Scott Roberts, MD, associate medical director for infection prevention at Yale New Haven (Conn.) Hospital.
Dr. Roberts recommended that patients speak with their health care providers and read about the bivalent booster on trusted sites such as those sponsored by the Food and Drug Administration and the Centers for Disease Control and Prevention. Long COVID patients should get the latest boosters, especially as there’s no evidence they are unsafe for them. “The antibody response is appropriately boosted, and there is a decent chance this will help reduce the impact of long COVID as well,” he said. “Waiting will only increase the risk of getting infected and increase the chances of long COVID.”
Only 12% of Americans 5 years and older have received the updated booster, according to the CDC, although it’s recommended for everyone. Just over 80% of Americans have gotten at least one vaccine dose. Dr. Thomas understands why the uptake has been so low: Along with people like Ms. Dishner, who fear more side effects or worse symptoms, there are those who believe that hybrid immunity – vaccination immunity plus natural infection – is superior to vaccination alone and that they don’t need a booster.
Studies show that the bivalent boosters, which protect against older and newer variants, can target even the new, predominant COVID-19 strains. Whether that is enough to convince people in the no-booster camp who lost faith when their vaccinated peers started getting COVID-19 is unclear, although, as Dr. Al-Aly has pointed out, vaccinations help keep people from getting so sick that they wind up in the hospital. And, with most of the population having received at least one dose of vaccine, most of those getting infected will naturally come from among the vaccinated.
Thomas describes the expectation that vaccines would prevent everyone from getting sick as “one of the major fails” of the pandemic.
Counting on a vaccine to confer 100% immunity is “a very high bar,” he said. “I think that’s what people expected, and when they weren’t seeing it, they kind of said: ‘Well, what’s the point? You know, things are getting better. I’d rather take my chances than keep going and getting boosted.’ ”
One point – and it’s a critical one – is that vaccination immunity wanes. Plus new variants arise that can evade at least some of the immunity provided by vaccination. That’s why boosters are built into the COVID vaccination program.
While it’s not clear why some long COVID patients see improvements in their symptoms after being vaccinated or boosted and others do not, Dr. Al-Aly said there’s little evidence vaccines can make long COVID worse. “There are some reports out there that some people with long COVID, when they got a vaccine or booster, their symptoms got worse. You’ll read anecdotes on this side,” he said, adding that efforts to see if this is really happening have been inconclusive.
“The general consensus is that vaccines really save lives,” Dr. Al-Aly said. “Getting vaccinated, even if you are a long COVID patient, is better than not getting vaccinated.”
A version of this article first appeared on WebMD.com.
Yet at 58, the Arizona writer is in no hurry to get the latest vaccine booster. “I just don’t want to risk getting any sicker,” she said.
Ms. Dishner has had two doses of vaccine plus two boosters. Each time, she had what regulators consider to be mild reactions, including a sore arm, slight fever, nausea, and body aches. Still, there’s some evidence that the newest booster, which protects against some of the later variants, could help people like Ms. Dishner in several ways, said Ziyad Al-Aly, MD, a clinical epidemiologist and prolific long COVID researcher at Washington University in St. Louis.
“A bivalent booster might actually [help with] your long COVID,” he said.
There may be other benefits. “What vaccines or current vaccine boosters do is reduce your risk of progression to severe COVID-19 illness,” Dr. Al-Aly said. “You are avoiding hospital stays or even worse; you’re avoiding potentially fatal outcomes after infection. And that’s really worth it. Who wants to be in the hospital this Christmas holiday?”
Each time people are infected with SARS-CoV-2, the virus that causes COVID-19, they have a fresh risk of not only getting severely ill or dying, but of developing long COVID, Dr. Al-Aly and colleagues found in a study published in Nature Medicine. “If you dodged the bullet the first time and did not get long COVID after the first infection, if you get reinfected, you’re trying your luck again,” Dr. Al-Aly said. “I would advise people not to get reinfected, which is another reason to get the booster.”
In a recent review in The Lancet eClinicalMedicine, an international team of researchers looked at 11 studies that sought to find out if vaccines affected long COVID symptoms. Seven of those studies found that people’s symptoms improved after they were vaccinated, and four found that symptoms mostly remained the same. One found symptoms got worse in some patients.
A study of 28,000 people published in the British Medical Journal found more evidence that vaccination may help ease symptoms. “Vaccination may contribute to a reduction in the population health burden of long COVID,” the team at the United Kingdom’s Office for National Statistics concluded. Most studies found vaccination reduced the risk of getting long COVID in the first place.
Vaccines prompt the body to produce antibodies, which stop a microbe from infecting cells. They also prompt the production of immune cells called T cells, which continue to hunt down and attack a pathogen even after infection.
A booster dose could help rev up that immune response in a patient with long COVID, said Stephen J. Thomas, MD, an infectious disease specialist at Upstate Medical Center in Syracuse, N.Y., and the center’s lead principal investigator for Pfizer/BioNTech’s COVID-19 2020 vaccine trial.
Some scientists believe long COVID might be caused when the virus persists in parts of the body where the immune system isn’t particularly active. Although they don’t fully understand the workings of the many and varied long COVID symptoms, they have a good idea about why people with long COVID often do better after receiving a vaccine or booster.
“The theory is that by boosting, the immune system may be able to ‘mop up’ those virus stragglers that have remained behind after your first cleanup attempt,” Dr. Thomas said.
“The vaccine is almost lending a hand or helping your immune response to clear that virus,” Dr. Al-Aly said.
It could be difficult for long COVID patients to make an informed decision about boosters, given the lack of studies that focus exclusively on the relationship between long COVID and boosters, according to Scott Roberts, MD, associate medical director for infection prevention at Yale New Haven (Conn.) Hospital.
Dr. Roberts recommended that patients speak with their health care providers and read about the bivalent booster on trusted sites such as those sponsored by the Food and Drug Administration and the Centers for Disease Control and Prevention. Long COVID patients should get the latest boosters, especially as there’s no evidence they are unsafe for them. “The antibody response is appropriately boosted, and there is a decent chance this will help reduce the impact of long COVID as well,” he said. “Waiting will only increase the risk of getting infected and increase the chances of long COVID.”
Only 12% of Americans 5 years and older have received the updated booster, according to the CDC, although it’s recommended for everyone. Just over 80% of Americans have gotten at least one vaccine dose. Dr. Thomas understands why the uptake has been so low: Along with people like Ms. Dishner, who fear more side effects or worse symptoms, there are those who believe that hybrid immunity – vaccination immunity plus natural infection – is superior to vaccination alone and that they don’t need a booster.
Studies show that the bivalent boosters, which protect against older and newer variants, can target even the new, predominant COVID-19 strains. Whether that is enough to convince people in the no-booster camp who lost faith when their vaccinated peers started getting COVID-19 is unclear, although, as Dr. Al-Aly has pointed out, vaccinations help keep people from getting so sick that they wind up in the hospital. And, with most of the population having received at least one dose of vaccine, most of those getting infected will naturally come from among the vaccinated.
Thomas describes the expectation that vaccines would prevent everyone from getting sick as “one of the major fails” of the pandemic.
Counting on a vaccine to confer 100% immunity is “a very high bar,” he said. “I think that’s what people expected, and when they weren’t seeing it, they kind of said: ‘Well, what’s the point? You know, things are getting better. I’d rather take my chances than keep going and getting boosted.’ ”
One point – and it’s a critical one – is that vaccination immunity wanes. Plus new variants arise that can evade at least some of the immunity provided by vaccination. That’s why boosters are built into the COVID vaccination program.
While it’s not clear why some long COVID patients see improvements in their symptoms after being vaccinated or boosted and others do not, Dr. Al-Aly said there’s little evidence vaccines can make long COVID worse. “There are some reports out there that some people with long COVID, when they got a vaccine or booster, their symptoms got worse. You’ll read anecdotes on this side,” he said, adding that efforts to see if this is really happening have been inconclusive.
“The general consensus is that vaccines really save lives,” Dr. Al-Aly said. “Getting vaccinated, even if you are a long COVID patient, is better than not getting vaccinated.”
A version of this article first appeared on WebMD.com.
Yet at 58, the Arizona writer is in no hurry to get the latest vaccine booster. “I just don’t want to risk getting any sicker,” she said.
Ms. Dishner has had two doses of vaccine plus two boosters. Each time, she had what regulators consider to be mild reactions, including a sore arm, slight fever, nausea, and body aches. Still, there’s some evidence that the newest booster, which protects against some of the later variants, could help people like Ms. Dishner in several ways, said Ziyad Al-Aly, MD, a clinical epidemiologist and prolific long COVID researcher at Washington University in St. Louis.
“A bivalent booster might actually [help with] your long COVID,” he said.
There may be other benefits. “What vaccines or current vaccine boosters do is reduce your risk of progression to severe COVID-19 illness,” Dr. Al-Aly said. “You are avoiding hospital stays or even worse; you’re avoiding potentially fatal outcomes after infection. And that’s really worth it. Who wants to be in the hospital this Christmas holiday?”
Each time people are infected with SARS-CoV-2, the virus that causes COVID-19, they have a fresh risk of not only getting severely ill or dying, but of developing long COVID, Dr. Al-Aly and colleagues found in a study published in Nature Medicine. “If you dodged the bullet the first time and did not get long COVID after the first infection, if you get reinfected, you’re trying your luck again,” Dr. Al-Aly said. “I would advise people not to get reinfected, which is another reason to get the booster.”
In a recent review in The Lancet eClinicalMedicine, an international team of researchers looked at 11 studies that sought to find out if vaccines affected long COVID symptoms. Seven of those studies found that people’s symptoms improved after they were vaccinated, and four found that symptoms mostly remained the same. One found symptoms got worse in some patients.
A study of 28,000 people published in the British Medical Journal found more evidence that vaccination may help ease symptoms. “Vaccination may contribute to a reduction in the population health burden of long COVID,” the team at the United Kingdom’s Office for National Statistics concluded. Most studies found vaccination reduced the risk of getting long COVID in the first place.
Vaccines prompt the body to produce antibodies, which stop a microbe from infecting cells. They also prompt the production of immune cells called T cells, which continue to hunt down and attack a pathogen even after infection.
A booster dose could help rev up that immune response in a patient with long COVID, said Stephen J. Thomas, MD, an infectious disease specialist at Upstate Medical Center in Syracuse, N.Y., and the center’s lead principal investigator for Pfizer/BioNTech’s COVID-19 2020 vaccine trial.
Some scientists believe long COVID might be caused when the virus persists in parts of the body where the immune system isn’t particularly active. Although they don’t fully understand the workings of the many and varied long COVID symptoms, they have a good idea about why people with long COVID often do better after receiving a vaccine or booster.
“The theory is that by boosting, the immune system may be able to ‘mop up’ those virus stragglers that have remained behind after your first cleanup attempt,” Dr. Thomas said.
“The vaccine is almost lending a hand or helping your immune response to clear that virus,” Dr. Al-Aly said.
It could be difficult for long COVID patients to make an informed decision about boosters, given the lack of studies that focus exclusively on the relationship between long COVID and boosters, according to Scott Roberts, MD, associate medical director for infection prevention at Yale New Haven (Conn.) Hospital.
Dr. Roberts recommended that patients speak with their health care providers and read about the bivalent booster on trusted sites such as those sponsored by the Food and Drug Administration and the Centers for Disease Control and Prevention. Long COVID patients should get the latest boosters, especially as there’s no evidence they are unsafe for them. “The antibody response is appropriately boosted, and there is a decent chance this will help reduce the impact of long COVID as well,” he said. “Waiting will only increase the risk of getting infected and increase the chances of long COVID.”
Only 12% of Americans 5 years and older have received the updated booster, according to the CDC, although it’s recommended for everyone. Just over 80% of Americans have gotten at least one vaccine dose. Dr. Thomas understands why the uptake has been so low: Along with people like Ms. Dishner, who fear more side effects or worse symptoms, there are those who believe that hybrid immunity – vaccination immunity plus natural infection – is superior to vaccination alone and that they don’t need a booster.
Studies show that the bivalent boosters, which protect against older and newer variants, can target even the new, predominant COVID-19 strains. Whether that is enough to convince people in the no-booster camp who lost faith when their vaccinated peers started getting COVID-19 is unclear, although, as Dr. Al-Aly has pointed out, vaccinations help keep people from getting so sick that they wind up in the hospital. And, with most of the population having received at least one dose of vaccine, most of those getting infected will naturally come from among the vaccinated.
Thomas describes the expectation that vaccines would prevent everyone from getting sick as “one of the major fails” of the pandemic.
Counting on a vaccine to confer 100% immunity is “a very high bar,” he said. “I think that’s what people expected, and when they weren’t seeing it, they kind of said: ‘Well, what’s the point? You know, things are getting better. I’d rather take my chances than keep going and getting boosted.’ ”
One point – and it’s a critical one – is that vaccination immunity wanes. Plus new variants arise that can evade at least some of the immunity provided by vaccination. That’s why boosters are built into the COVID vaccination program.
While it’s not clear why some long COVID patients see improvements in their symptoms after being vaccinated or boosted and others do not, Dr. Al-Aly said there’s little evidence vaccines can make long COVID worse. “There are some reports out there that some people with long COVID, when they got a vaccine or booster, their symptoms got worse. You’ll read anecdotes on this side,” he said, adding that efforts to see if this is really happening have been inconclusive.
“The general consensus is that vaccines really save lives,” Dr. Al-Aly said. “Getting vaccinated, even if you are a long COVID patient, is better than not getting vaccinated.”
A version of this article first appeared on WebMD.com.
FROM NATURE MEDICINE