The Omicron surge accelerated as weekly cases of COVID-19 in children reached 580,000 for the first week of 2022, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The total for the week of Dec. 31 to Jan. 6 – the highest since the pandemic began – was an increase of 78% over the previous week (325,000) and 192% higher than just 2 weeks before (199,000), the AAP and CHA said in their weekly COVID-19 report. No region of the country was spared, as all four saw at least 50,000 more cases than the week before, but the increase was largest in the West and smallest in the Midwest.

“Nearly 8.5 million children have tested positive for COVID-19 since the onset of the pandemic; nearly 11% of these cases have been added in the past 2 weeks,” the AAP said.

The situation is the same for hospitalizations. On Dec. 15, the daily rate of new admissions for children aged 0-17 years was 0.26 per 100,000, and by Jan. 7 it had more than quadrupled to 1.15 per 100,000, the Centers for Disease Control and Prevention reported. Before Omicron, the highest rate was 0.47 per 100,000 on Sept. 4, 2021.

The number of children occupying inpatient beds who had laboratory-confirmed COVID-19 went from 2,343 on Jan. 2 to 3,476 on Jan. 9, a jump of more than 48% in just 1 week. Texas had more hospitalized children (392) than any other state on Jan. 9, with California (339) and New York (313) the only other states over 300, according to data from the Department of Health & Human Services.

For vaccinations. however, the situation is definitely not the same. The number of children added to the ranks of those with at least one dose of COVID-19 vaccine was down in early 2022 (Jan. 3-9) for both 5- to 11-year-olds (–8.2%) and 16- to 17-year-olds (–12.2%) but higher among those aged 12-15 (12.2%), compared with the previous week (Dec. 27 to Jan. 2), the CDC said on its COVID Data Tracker.

Cumulative figures show that 26.3% of all children aged 5-11 had received at least one dose of vaccine and 17.2% were fully vaccinated as of Jan. 10, compared with 62.2% and 52.0% of 12- to 15-year-olds and 68.5% and 58.1% of those aged 16-17. Altogether, over 23.8 million children in those three age groups have received at least one dose and almost 18.6 million are fully vaccinated, the CDC said.
 

The Omicron surge accelerated as weekly cases of COVID-19 in children reached 580,000 for the first week of 2022, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The total for the week of Dec. 31 to Jan. 6 – the highest since the pandemic began – was an increase of 78% over the previous week (325,000) and 192% higher than just 2 weeks before (199,000), the AAP and CHA said in their weekly COVID-19 report. No region of the country was spared, as all four saw at least 50,000 more cases than the week before, but the increase was largest in the West and smallest in the Midwest.

“Nearly 8.5 million children have tested positive for COVID-19 since the onset of the pandemic; nearly 11% of these cases have been added in the past 2 weeks,” the AAP said.

The situation is the same for hospitalizations. On Dec. 15, the daily rate of new admissions for children aged 0-17 years was 0.26 per 100,000, and by Jan. 7 it had more than quadrupled to 1.15 per 100,000, the Centers for Disease Control and Prevention reported. Before Omicron, the highest rate was 0.47 per 100,000 on Sept. 4, 2021.

The number of children occupying inpatient beds who had laboratory-confirmed COVID-19 went from 2,343 on Jan. 2 to 3,476 on Jan. 9, a jump of more than 48% in just 1 week. Texas had more hospitalized children (392) than any other state on Jan. 9, with California (339) and New York (313) the only other states over 300, according to data from the Department of Health & Human Services.

For vaccinations. however, the situation is definitely not the same. The number of children added to the ranks of those with at least one dose of COVID-19 vaccine was down in early 2022 (Jan. 3-9) for both 5- to 11-year-olds (–8.2%) and 16- to 17-year-olds (–12.2%) but higher among those aged 12-15 (12.2%), compared with the previous week (Dec. 27 to Jan. 2), the CDC said on its COVID Data Tracker.

Cumulative figures show that 26.3% of all children aged 5-11 had received at least one dose of vaccine and 17.2% were fully vaccinated as of Jan. 10, compared with 62.2% and 52.0% of 12- to 15-year-olds and 68.5% and 58.1% of those aged 16-17. Altogether, over 23.8 million children in those three age groups have received at least one dose and almost 18.6 million are fully vaccinated, the CDC said.
 

The Omicron surge accelerated as weekly cases of COVID-19 in children reached 580,000 for the first week of 2022, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The total for the week of Dec. 31 to Jan. 6 – the highest since the pandemic began – was an increase of 78% over the previous week (325,000) and 192% higher than just 2 weeks before (199,000), the AAP and CHA said in their weekly COVID-19 report. No region of the country was spared, as all four saw at least 50,000 more cases than the week before, but the increase was largest in the West and smallest in the Midwest.

“Nearly 8.5 million children have tested positive for COVID-19 since the onset of the pandemic; nearly 11% of these cases have been added in the past 2 weeks,” the AAP said.

The situation is the same for hospitalizations. On Dec. 15, the daily rate of new admissions for children aged 0-17 years was 0.26 per 100,000, and by Jan. 7 it had more than quadrupled to 1.15 per 100,000, the Centers for Disease Control and Prevention reported. Before Omicron, the highest rate was 0.47 per 100,000 on Sept. 4, 2021.

The number of children occupying inpatient beds who had laboratory-confirmed COVID-19 went from 2,343 on Jan. 2 to 3,476 on Jan. 9, a jump of more than 48% in just 1 week. Texas had more hospitalized children (392) than any other state on Jan. 9, with California (339) and New York (313) the only other states over 300, according to data from the Department of Health & Human Services.

For vaccinations. however, the situation is definitely not the same. The number of children added to the ranks of those with at least one dose of COVID-19 vaccine was down in early 2022 (Jan. 3-9) for both 5- to 11-year-olds (–8.2%) and 16- to 17-year-olds (–12.2%) but higher among those aged 12-15 (12.2%), compared with the previous week (Dec. 27 to Jan. 2), the CDC said on its COVID Data Tracker.

Cumulative figures show that 26.3% of all children aged 5-11 had received at least one dose of vaccine and 17.2% were fully vaccinated as of Jan. 10, compared with 62.2% and 52.0% of 12- to 15-year-olds and 68.5% and 58.1% of those aged 16-17. Altogether, over 23.8 million children in those three age groups have received at least one dose and almost 18.6 million are fully vaccinated, the CDC said.
 

In an observational study of more than 90,000 U.S. health care professionals, consuming even a small amount of olive oil was associated with reduced total mortality.

Compared with men and women who rarely or never consumed olive oil (the lowest intake), those who consumed greater than 0.5 tablespoon/day or more than 7 g/day (the highest intake) had a 19% lower mortality risk over a 28-year follow-up, starting from an average age of 56 years.

Moreover, compared with those with the lowest olive oil intake, those with the highest intake had a 19% lower cardiovascular disease (CVD) mortality, a 17% lower risk of dying from cancer, a 29% lower risk of dying from neurodegenerative disease, and an 18% lower risk of dying from respiratory disease during follow-up.

masa44/iStock/Getty Images

The researchers estimate that replacing 10 g/day of margarine, butter, mayonnaise, or dairy fat with the same amount of olive oil is associated with an 8%-34% lower risk of death from various causes.

The study by Marta Guasch-Ferré, PhD, and colleagues was published online Jan. 10 in the Journal of the American College of Cardiology.
 

Results support plant-based dietary fat recommendations

“Our results support current dietary recommendations to increase the intake of olive oil and other unsaturated vegetable oils in place of other fats to improve overall health and longevity,” the researchers summarize.

However, “I wouldn’t say that olive oil is the only way to help you live longer,” Dr. Guasch-Ferré, a senior research scientist in the department of nutrition, Harvard T.H. Chan School of Public Health, Boston, cautioned in an interview with this news organization.

“Other things are very important, such as not smoking, doing physical activity, etc., but one recommendation could be to try to eat more plant-based food including olive oil and healthy fat,” she added, and to use it for cooking, salad dressing, and baking, and substitute it for saturated fat or animal fat, especially for cooking.

The study suggests that people should “consume a more plant-based diet and prioritize fatty acids such as olive oil because they have a better nutritional composition (high in phenols and antioxidants), instead of using butter or margarines or other animal fats that have been shown to have detrimental effects for health,” she added, which is consistent with recommendations in the Dietary Guidelines for Americans.

“That said,” Dr. Guasch-Ferré summarized, “replication is needed in other cohorts and populations to see if the results are similar.”

In an accompanying editorial, Susanna C. Larsson, PhD, writes that “this was a well-designed study, with long-term follow-up and repeated measurements of dietary intake and other risk factors for diseases.”

“However, the difference in olive oil consumption between those with the highest and those with the lowest/no olive oil consumption was very low (0.5 tablespoon) and a [12%] reduced mortality risk was observed already at a much lower intake (0.5 teaspoon, about 1.5 g/day) of olive oil,” she noted in an email to this news organization.

“It’s a bit hard to believe that such a small amount could have an independent effect on mortality risk,” Dr. Larsson, associate professor of epidemiology at the Karolinska Institutet, Stockholm, cautioned.

Like Dr. Guasch-Ferré, she noted that “just adding one or two teaspoons of olive oil to the diet each day will likely not change the risk of mortality.”

Rather, “people may need to make larger changes in the whole diet, not focus on fat only. An overall healthier diet, rich in nonrefined plant-based foods (vegetables, whole grains, nuts), low/no intake of processed foods, and a switch to healthier fat (eg, olive oil) is needed.”

Importantly, “this study cannot say anything about causality, that is, whether it’s olive oil specifically that reduces mortality risk or if there are many other beneficial factors that act together to reduce mortality rate among those with high olive oil consumption.”

The researchers acknowledge this observational study limitation and that the findings may not be generalizable to other populations.
 

Novel findings regarding Alzheimer’s and respiratory disease

Dr. Larsson highlights two novel findings of this study.

First, it showed a 27% reduction in risk of dementia-related mortality for those in the highest versus lowest category of olive oil consumption. “Considering the lack of preventive strategies for Alzheimer’s disease and the high morbidity and mortality related to this disease, this finding, if confirmed, is of great public health importance,” she said.

Second, the study reported an inverse association of olive oil consumption with risk of respiratory disease mortality. “Because residual confounding from smoking cannot be ruled out,” Dr. Larsson said, “this finding is tentative and requires confirmation in a study that is less susceptible to confounding, such as a randomized trial.”

And although the current study and previous studies have found that consumption of olive oil may have health benefits, she identified several remaining questions.

“Are the associations causal or spurious?” she noted. Is olive oil consumption protective for certain cardiovascular diseases like stroke or atrial fibrillation only, as has been shown in other studies, or also for other major diseases and causes of death, she added. What is the amount of olive oil required for a protective effect?

Further, is the potential effect related to monounsaturated fatty acids (MUFAs) or phenolic compounds; that is, “is the protective effect confined to polyphenol-rich extra-virgin olive oil or are refined olive oil and other vegetable oils as beneficial? More research is needed to address these questions,” she concludes.

“Further studies are needed,” the researchers agree, “to confirm the association of olive oil consumption with reduced mortality, clarify the mechanisms responsible, and quantify the dose/volume boundaries around this effect.”  
 

Virgin olive oil has more polyphenols

Olive oil, a key component of the Mediterranean diet, is high in MUFAs, especially oleic acid, as well as vitamin E and polyphenols, which contribute to its anti-inflammatory and antioxidant properties, the researchers explain.

Virgin olive oil, produced by mechanically pressing ripe olives, contains multiple bioactive and antioxidant components and has an acidity of less than 1.5%. And extra-virgin olive oil is produced the same way but has a higher quality, more intense taste, and lower acidity (less than 1%).

Refined or processed olive oil contains less phytochemicals, as some are lost during processing; it usually contains more than 80% refined oil, plus virgin oil added back to enhance flavor, and may also be labeled “pure” or “light.” However, refined olive oil “still has a good amount of healthy fatty acids but less bioactive compounds,” Dr. Guasch-Ferré noted.

Until now, no large prospective study has examined the link between olive oil intake and all-cause and cause-specific mortality in a U.S. population, where olive oil consumption is limited, compared with Mediterranean countries.

The researchers identified 60,582 women in the Nurses’ Health Study and 31,801 men in the Health Professionals Follow-up Study who were free of CVD or cancer in 1990, the first year that food frequency questionnaires in these studies asked about olive oil.

Participants replied to questionnaires every 4 years that asked about use of olive oil (for salad dressing, baking, frying, sautéing, and spreading on bread), other vegetable oils (for example, corn, safflower, soybean, canola oil), margarine, butter, and dairy fat. The researchers averaged the consumption of these fats during the follow-up years.

From 1990 to 2019, the average consumption of olive oil increased from 1.6 g/day to 4 g/day. Margarine in the 1990s contained saturated fat and trans fats, whereas more recently margarine contains beneficial olive oil or vegetable fat, Dr. Guasch-Ferré noted.

Baseline olive oil consumption in this U.S. population “differed remarkably” from that in the Spanish population in the PREDIMED (Prevención con Dieta Mediterránea) trial, which was, on average, 20-22 g/day of extra-virgin olive oil and 16-18 g/day of refined/mixed olive oil, Larsson pointed out.

Because olive oil consumption was so low in this U.S. study, the researchers did not distinguish between virgin/extra-virgin olive oil and refined/processed olive oil.

The participants were almost all White (99%) and were generally healthier than the average U.S. population; on average, they had a body mass index of 25.3-25.8 kg/m² and ate 4.8-7.2 fruits and vegetables/day.

Those with the highest olive oil consumption were more physically active, had a healthier diet, were more likely to have Southern European or Mediterranean ancestry, and were less likely to smoke.

During 28 years of follow-up, 36,856 participants died. The researchers classified the deaths into five categories: CVD, cancer, neurodegenerative disease (including Alzheimer’s disease, Parkinson’s disease, multiple sclerosis), respiratory disease (such as chronic obstructive pulmonary disease), and all other causes (including suicide, injury, infections, diabetes, and kidney disease).

After adjusting for multiple confounders, compared with participants who rarely or never consumed olive oil, those in the highest quartile for olive oil consumption had a decreased risk of death from all causes (hazard ratio, 0.81; 95% confidence interval, 0.78 - 0.84) and from CVD (HR, 0.81; 95% CI, 0.75-0.87), cancer (HR, 0.83; 95% CI, 0.78-0.89), neurodegenerative disease (HR, 0.71; 95% CI, 0.64-0.78), and respiratory disease (HR, 0.82; 95% CI, 0.72-0.93). 

There was no decrease in mortality in models where the researchers substituted olive oil for vegetable oil, suggesting that vegetable oils may provide similar health benefits as olive oil.

The research was supported by grants from the National Institutes of Health. Dr. Guasch-Ferré was supported by the American Diabetes Association. Coauthor Salas-Salvadó is partially supported by the Catalan Institution for Research and Advanced Studies and received the virgin olive oil that was used in the PREDIMED and PREDIMED-Plus studies from the Patrimonio Communal Olivalero and Hojiblanca (Málaga, Spain). The other study authors and Dr. Larsson have reported no relevant financial relationships.

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

In an observational study of more than 90,000 U.S. health care professionals, consuming even a small amount of olive oil was associated with reduced total mortality.

Compared with men and women who rarely or never consumed olive oil (the lowest intake), those who consumed greater than 0.5 tablespoon/day or more than 7 g/day (the highest intake) had a 19% lower mortality risk over a 28-year follow-up, starting from an average age of 56 years.

Moreover, compared with those with the lowest olive oil intake, those with the highest intake had a 19% lower cardiovascular disease (CVD) mortality, a 17% lower risk of dying from cancer, a 29% lower risk of dying from neurodegenerative disease, and an 18% lower risk of dying from respiratory disease during follow-up.

masa44/iStock/Getty Images

The researchers estimate that replacing 10 g/day of margarine, butter, mayonnaise, or dairy fat with the same amount of olive oil is associated with an 8%-34% lower risk of death from various causes.

The study by Marta Guasch-Ferré, PhD, and colleagues was published online Jan. 10 in the Journal of the American College of Cardiology.
 

Results support plant-based dietary fat recommendations

“Our results support current dietary recommendations to increase the intake of olive oil and other unsaturated vegetable oils in place of other fats to improve overall health and longevity,” the researchers summarize.

However, “I wouldn’t say that olive oil is the only way to help you live longer,” Dr. Guasch-Ferré, a senior research scientist in the department of nutrition, Harvard T.H. Chan School of Public Health, Boston, cautioned in an interview with this news organization.

“Other things are very important, such as not smoking, doing physical activity, etc., but one recommendation could be to try to eat more plant-based food including olive oil and healthy fat,” she added, and to use it for cooking, salad dressing, and baking, and substitute it for saturated fat or animal fat, especially for cooking.

The study suggests that people should “consume a more plant-based diet and prioritize fatty acids such as olive oil because they have a better nutritional composition (high in phenols and antioxidants), instead of using butter or margarines or other animal fats that have been shown to have detrimental effects for health,” she added, which is consistent with recommendations in the Dietary Guidelines for Americans.

“That said,” Dr. Guasch-Ferré summarized, “replication is needed in other cohorts and populations to see if the results are similar.”

In an accompanying editorial, Susanna C. Larsson, PhD, writes that “this was a well-designed study, with long-term follow-up and repeated measurements of dietary intake and other risk factors for diseases.”

“However, the difference in olive oil consumption between those with the highest and those with the lowest/no olive oil consumption was very low (0.5 tablespoon) and a [12%] reduced mortality risk was observed already at a much lower intake (0.5 teaspoon, about 1.5 g/day) of olive oil,” she noted in an email to this news organization.

“It’s a bit hard to believe that such a small amount could have an independent effect on mortality risk,” Dr. Larsson, associate professor of epidemiology at the Karolinska Institutet, Stockholm, cautioned.

Like Dr. Guasch-Ferré, she noted that “just adding one or two teaspoons of olive oil to the diet each day will likely not change the risk of mortality.”

Rather, “people may need to make larger changes in the whole diet, not focus on fat only. An overall healthier diet, rich in nonrefined plant-based foods (vegetables, whole grains, nuts), low/no intake of processed foods, and a switch to healthier fat (eg, olive oil) is needed.”

Importantly, “this study cannot say anything about causality, that is, whether it’s olive oil specifically that reduces mortality risk or if there are many other beneficial factors that act together to reduce mortality rate among those with high olive oil consumption.”

The researchers acknowledge this observational study limitation and that the findings may not be generalizable to other populations.
 

Novel findings regarding Alzheimer’s and respiratory disease

Dr. Larsson highlights two novel findings of this study.

First, it showed a 27% reduction in risk of dementia-related mortality for those in the highest versus lowest category of olive oil consumption. “Considering the lack of preventive strategies for Alzheimer’s disease and the high morbidity and mortality related to this disease, this finding, if confirmed, is of great public health importance,” she said.

Second, the study reported an inverse association of olive oil consumption with risk of respiratory disease mortality. “Because residual confounding from smoking cannot be ruled out,” Dr. Larsson said, “this finding is tentative and requires confirmation in a study that is less susceptible to confounding, such as a randomized trial.”

And although the current study and previous studies have found that consumption of olive oil may have health benefits, she identified several remaining questions.

“Are the associations causal or spurious?” she noted. Is olive oil consumption protective for certain cardiovascular diseases like stroke or atrial fibrillation only, as has been shown in other studies, or also for other major diseases and causes of death, she added. What is the amount of olive oil required for a protective effect?

Further, is the potential effect related to monounsaturated fatty acids (MUFAs) or phenolic compounds; that is, “is the protective effect confined to polyphenol-rich extra-virgin olive oil or are refined olive oil and other vegetable oils as beneficial? More research is needed to address these questions,” she concludes.

“Further studies are needed,” the researchers agree, “to confirm the association of olive oil consumption with reduced mortality, clarify the mechanisms responsible, and quantify the dose/volume boundaries around this effect.”  
 

Virgin olive oil has more polyphenols

Olive oil, a key component of the Mediterranean diet, is high in MUFAs, especially oleic acid, as well as vitamin E and polyphenols, which contribute to its anti-inflammatory and antioxidant properties, the researchers explain.

Virgin olive oil, produced by mechanically pressing ripe olives, contains multiple bioactive and antioxidant components and has an acidity of less than 1.5%. And extra-virgin olive oil is produced the same way but has a higher quality, more intense taste, and lower acidity (less than 1%).

Refined or processed olive oil contains less phytochemicals, as some are lost during processing; it usually contains more than 80% refined oil, plus virgin oil added back to enhance flavor, and may also be labeled “pure” or “light.” However, refined olive oil “still has a good amount of healthy fatty acids but less bioactive compounds,” Dr. Guasch-Ferré noted.

Until now, no large prospective study has examined the link between olive oil intake and all-cause and cause-specific mortality in a U.S. population, where olive oil consumption is limited, compared with Mediterranean countries.

The researchers identified 60,582 women in the Nurses’ Health Study and 31,801 men in the Health Professionals Follow-up Study who were free of CVD or cancer in 1990, the first year that food frequency questionnaires in these studies asked about olive oil.

Participants replied to questionnaires every 4 years that asked about use of olive oil (for salad dressing, baking, frying, sautéing, and spreading on bread), other vegetable oils (for example, corn, safflower, soybean, canola oil), margarine, butter, and dairy fat. The researchers averaged the consumption of these fats during the follow-up years.

From 1990 to 2019, the average consumption of olive oil increased from 1.6 g/day to 4 g/day. Margarine in the 1990s contained saturated fat and trans fats, whereas more recently margarine contains beneficial olive oil or vegetable fat, Dr. Guasch-Ferré noted.

Baseline olive oil consumption in this U.S. population “differed remarkably” from that in the Spanish population in the PREDIMED (Prevención con Dieta Mediterránea) trial, which was, on average, 20-22 g/day of extra-virgin olive oil and 16-18 g/day of refined/mixed olive oil, Larsson pointed out.

Because olive oil consumption was so low in this U.S. study, the researchers did not distinguish between virgin/extra-virgin olive oil and refined/processed olive oil.

The participants were almost all White (99%) and were generally healthier than the average U.S. population; on average, they had a body mass index of 25.3-25.8 kg/m² and ate 4.8-7.2 fruits and vegetables/day.

Those with the highest olive oil consumption were more physically active, had a healthier diet, were more likely to have Southern European or Mediterranean ancestry, and were less likely to smoke.

During 28 years of follow-up, 36,856 participants died. The researchers classified the deaths into five categories: CVD, cancer, neurodegenerative disease (including Alzheimer’s disease, Parkinson’s disease, multiple sclerosis), respiratory disease (such as chronic obstructive pulmonary disease), and all other causes (including suicide, injury, infections, diabetes, and kidney disease).

After adjusting for multiple confounders, compared with participants who rarely or never consumed olive oil, those in the highest quartile for olive oil consumption had a decreased risk of death from all causes (hazard ratio, 0.81; 95% confidence interval, 0.78 - 0.84) and from CVD (HR, 0.81; 95% CI, 0.75-0.87), cancer (HR, 0.83; 95% CI, 0.78-0.89), neurodegenerative disease (HR, 0.71; 95% CI, 0.64-0.78), and respiratory disease (HR, 0.82; 95% CI, 0.72-0.93). 

There was no decrease in mortality in models where the researchers substituted olive oil for vegetable oil, suggesting that vegetable oils may provide similar health benefits as olive oil.

The research was supported by grants from the National Institutes of Health. Dr. Guasch-Ferré was supported by the American Diabetes Association. Coauthor Salas-Salvadó is partially supported by the Catalan Institution for Research and Advanced Studies and received the virgin olive oil that was used in the PREDIMED and PREDIMED-Plus studies from the Patrimonio Communal Olivalero and Hojiblanca (Málaga, Spain). The other study authors and Dr. Larsson have reported no relevant financial relationships.

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

In an observational study of more than 90,000 U.S. health care professionals, consuming even a small amount of olive oil was associated with reduced total mortality.

Compared with men and women who rarely or never consumed olive oil (the lowest intake), those who consumed greater than 0.5 tablespoon/day or more than 7 g/day (the highest intake) had a 19% lower mortality risk over a 28-year follow-up, starting from an average age of 56 years.

Moreover, compared with those with the lowest olive oil intake, those with the highest intake had a 19% lower cardiovascular disease (CVD) mortality, a 17% lower risk of dying from cancer, a 29% lower risk of dying from neurodegenerative disease, and an 18% lower risk of dying from respiratory disease during follow-up.

masa44/iStock/Getty Images

The researchers estimate that replacing 10 g/day of margarine, butter, mayonnaise, or dairy fat with the same amount of olive oil is associated with an 8%-34% lower risk of death from various causes.

The study by Marta Guasch-Ferré, PhD, and colleagues was published online Jan. 10 in the Journal of the American College of Cardiology.
 

Results support plant-based dietary fat recommendations

“Our results support current dietary recommendations to increase the intake of olive oil and other unsaturated vegetable oils in place of other fats to improve overall health and longevity,” the researchers summarize.

However, “I wouldn’t say that olive oil is the only way to help you live longer,” Dr. Guasch-Ferré, a senior research scientist in the department of nutrition, Harvard T.H. Chan School of Public Health, Boston, cautioned in an interview with this news organization.

“Other things are very important, such as not smoking, doing physical activity, etc., but one recommendation could be to try to eat more plant-based food including olive oil and healthy fat,” she added, and to use it for cooking, salad dressing, and baking, and substitute it for saturated fat or animal fat, especially for cooking.

The study suggests that people should “consume a more plant-based diet and prioritize fatty acids such as olive oil because they have a better nutritional composition (high in phenols and antioxidants), instead of using butter or margarines or other animal fats that have been shown to have detrimental effects for health,” she added, which is consistent with recommendations in the Dietary Guidelines for Americans.

“That said,” Dr. Guasch-Ferré summarized, “replication is needed in other cohorts and populations to see if the results are similar.”

In an accompanying editorial, Susanna C. Larsson, PhD, writes that “this was a well-designed study, with long-term follow-up and repeated measurements of dietary intake and other risk factors for diseases.”

“However, the difference in olive oil consumption between those with the highest and those with the lowest/no olive oil consumption was very low (0.5 tablespoon) and a [12%] reduced mortality risk was observed already at a much lower intake (0.5 teaspoon, about 1.5 g/day) of olive oil,” she noted in an email to this news organization.

“It’s a bit hard to believe that such a small amount could have an independent effect on mortality risk,” Dr. Larsson, associate professor of epidemiology at the Karolinska Institutet, Stockholm, cautioned.

Like Dr. Guasch-Ferré, she noted that “just adding one or two teaspoons of olive oil to the diet each day will likely not change the risk of mortality.”

Rather, “people may need to make larger changes in the whole diet, not focus on fat only. An overall healthier diet, rich in nonrefined plant-based foods (vegetables, whole grains, nuts), low/no intake of processed foods, and a switch to healthier fat (eg, olive oil) is needed.”

Importantly, “this study cannot say anything about causality, that is, whether it’s olive oil specifically that reduces mortality risk or if there are many other beneficial factors that act together to reduce mortality rate among those with high olive oil consumption.”

The researchers acknowledge this observational study limitation and that the findings may not be generalizable to other populations.
 

Novel findings regarding Alzheimer’s and respiratory disease

Dr. Larsson highlights two novel findings of this study.

First, it showed a 27% reduction in risk of dementia-related mortality for those in the highest versus lowest category of olive oil consumption. “Considering the lack of preventive strategies for Alzheimer’s disease and the high morbidity and mortality related to this disease, this finding, if confirmed, is of great public health importance,” she said.

Second, the study reported an inverse association of olive oil consumption with risk of respiratory disease mortality. “Because residual confounding from smoking cannot be ruled out,” Dr. Larsson said, “this finding is tentative and requires confirmation in a study that is less susceptible to confounding, such as a randomized trial.”

And although the current study and previous studies have found that consumption of olive oil may have health benefits, she identified several remaining questions.

“Are the associations causal or spurious?” she noted. Is olive oil consumption protective for certain cardiovascular diseases like stroke or atrial fibrillation only, as has been shown in other studies, or also for other major diseases and causes of death, she added. What is the amount of olive oil required for a protective effect?

Further, is the potential effect related to monounsaturated fatty acids (MUFAs) or phenolic compounds; that is, “is the protective effect confined to polyphenol-rich extra-virgin olive oil or are refined olive oil and other vegetable oils as beneficial? More research is needed to address these questions,” she concludes.

“Further studies are needed,” the researchers agree, “to confirm the association of olive oil consumption with reduced mortality, clarify the mechanisms responsible, and quantify the dose/volume boundaries around this effect.”  
 

Virgin olive oil has more polyphenols

Olive oil, a key component of the Mediterranean diet, is high in MUFAs, especially oleic acid, as well as vitamin E and polyphenols, which contribute to its anti-inflammatory and antioxidant properties, the researchers explain.

Virgin olive oil, produced by mechanically pressing ripe olives, contains multiple bioactive and antioxidant components and has an acidity of less than 1.5%. And extra-virgin olive oil is produced the same way but has a higher quality, more intense taste, and lower acidity (less than 1%).

Refined or processed olive oil contains less phytochemicals, as some are lost during processing; it usually contains more than 80% refined oil, plus virgin oil added back to enhance flavor, and may also be labeled “pure” or “light.” However, refined olive oil “still has a good amount of healthy fatty acids but less bioactive compounds,” Dr. Guasch-Ferré noted.

Until now, no large prospective study has examined the link between olive oil intake and all-cause and cause-specific mortality in a U.S. population, where olive oil consumption is limited, compared with Mediterranean countries.

The researchers identified 60,582 women in the Nurses’ Health Study and 31,801 men in the Health Professionals Follow-up Study who were free of CVD or cancer in 1990, the first year that food frequency questionnaires in these studies asked about olive oil.

Participants replied to questionnaires every 4 years that asked about use of olive oil (for salad dressing, baking, frying, sautéing, and spreading on bread), other vegetable oils (for example, corn, safflower, soybean, canola oil), margarine, butter, and dairy fat. The researchers averaged the consumption of these fats during the follow-up years.

From 1990 to 2019, the average consumption of olive oil increased from 1.6 g/day to 4 g/day. Margarine in the 1990s contained saturated fat and trans fats, whereas more recently margarine contains beneficial olive oil or vegetable fat, Dr. Guasch-Ferré noted.

Baseline olive oil consumption in this U.S. population “differed remarkably” from that in the Spanish population in the PREDIMED (Prevención con Dieta Mediterránea) trial, which was, on average, 20-22 g/day of extra-virgin olive oil and 16-18 g/day of refined/mixed olive oil, Larsson pointed out.

Because olive oil consumption was so low in this U.S. study, the researchers did not distinguish between virgin/extra-virgin olive oil and refined/processed olive oil.

The participants were almost all White (99%) and were generally healthier than the average U.S. population; on average, they had a body mass index of 25.3-25.8 kg/m² and ate 4.8-7.2 fruits and vegetables/day.

Those with the highest olive oil consumption were more physically active, had a healthier diet, were more likely to have Southern European or Mediterranean ancestry, and were less likely to smoke.

During 28 years of follow-up, 36,856 participants died. The researchers classified the deaths into five categories: CVD, cancer, neurodegenerative disease (including Alzheimer’s disease, Parkinson’s disease, multiple sclerosis), respiratory disease (such as chronic obstructive pulmonary disease), and all other causes (including suicide, injury, infections, diabetes, and kidney disease).

After adjusting for multiple confounders, compared with participants who rarely or never consumed olive oil, those in the highest quartile for olive oil consumption had a decreased risk of death from all causes (hazard ratio, 0.81; 95% confidence interval, 0.78 - 0.84) and from CVD (HR, 0.81; 95% CI, 0.75-0.87), cancer (HR, 0.83; 95% CI, 0.78-0.89), neurodegenerative disease (HR, 0.71; 95% CI, 0.64-0.78), and respiratory disease (HR, 0.82; 95% CI, 0.72-0.93). 

There was no decrease in mortality in models where the researchers substituted olive oil for vegetable oil, suggesting that vegetable oils may provide similar health benefits as olive oil.

The research was supported by grants from the National Institutes of Health. Dr. Guasch-Ferré was supported by the American Diabetes Association. Coauthor Salas-Salvadó is partially supported by the Catalan Institution for Research and Advanced Studies and received the virgin olive oil that was used in the PREDIMED and PREDIMED-Plus studies from the Patrimonio Communal Olivalero and Hojiblanca (Málaga, Spain). The other study authors and Dr. Larsson have reported no relevant financial relationships.

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

The United States reported 1.35 million new COVID-19 cases on Jan. 10, logging the highest daily total for any country in the world during the pandemic.

The United States set the previous record of 1 million cases on Jan. 3. (A large number of cases are reported on Mondays, since many states don’t provide updates over the weekend, according to Reuters.)

Still, the 7-day average for new cases has surpassed 700,000, tripling in 2 weeks as the contagious Omicron variant continues to spread across the country.

The daily record of new cases came a day after the United States crossed the grim milestone of 60 million COVID-19 cases during the pandemic, according to the latest data from Johns Hopkins University. More than 11 million new cases were reported in the past 28 days, with 5 million reported since Jan. 2.

Globally, more than 310 million cases have been reported, resulting in nearly 5.5 million COVID-19 deaths. Almost 40 million cases have been confirmed worldwide during the past month, with the United States accounting for 28% of those.

Texas became the second state to report more than 5 million cases since the pandemic began, behind California’s total of 6 million cases. Florida has reported more than 4.6 million, while New York has reported more than 4.1 million.

The United States has also hit an all-time high for hospitalizations, with nearly 146,000 COVID-19 patients in hospitals across the country, according to the latest data from the U.S. Department of Health and Human Services. The previous record was 142,000 hospitalizations in January 2021.

Jan. 11’s hospitalizations are more than twice as many as 2 weeks ago, according to CNN. About 78% of inpatient beds are in use nationwide, and 21% are being used for COVID-19 patients.

Deaths are averaging about 1,700 per day, Reuters reported, which is up from 1,400 in recent days but not much higher than earlier this winter. The peak average was 3,400 daily deaths in mid-January 2021.

The surging numbers of cases and hospitalizations across the country are straining hospitals. On Jan. 10, Virginia Gov. Ralph Northam declared a state of emergency after the number of intensive care unit hospitalizations more than doubled since Dec. 1, CNN reported. The order allows hospitals to expand bed capacity, use telehealth options, and be more flexible with staffing.

Texas is hiring at least 2,700 medical staff to help with the surge, CNN reported, and Kentucky has mobilized the National Guard to provide support.

“Omicron continues to burn through the commonwealth, growing at levels we have never seen before. Omicron is significantly more contagious than even the Delta variant,” Kentucky Gov. Andy Beshear said during a news briefing Jan. 10.

Kentucky reported its highest weekly total of cases last week and has its highest rate of positive tests, at 26%. Mr. Beshear said the state is down to 134 available adult ICU beds.

“If it spreads at the rate we are seeing, it is certainly going to fill up our hospitals,” he said.

A version of this article first appeared on WebMD.com.

The United States reported 1.35 million new COVID-19 cases on Jan. 10, logging the highest daily total for any country in the world during the pandemic.

The United States set the previous record of 1 million cases on Jan. 3. (A large number of cases are reported on Mondays, since many states don’t provide updates over the weekend, according to Reuters.)

Still, the 7-day average for new cases has surpassed 700,000, tripling in 2 weeks as the contagious Omicron variant continues to spread across the country.

The daily record of new cases came a day after the United States crossed the grim milestone of 60 million COVID-19 cases during the pandemic, according to the latest data from Johns Hopkins University. More than 11 million new cases were reported in the past 28 days, with 5 million reported since Jan. 2.

Globally, more than 310 million cases have been reported, resulting in nearly 5.5 million COVID-19 deaths. Almost 40 million cases have been confirmed worldwide during the past month, with the United States accounting for 28% of those.

Texas became the second state to report more than 5 million cases since the pandemic began, behind California’s total of 6 million cases. Florida has reported more than 4.6 million, while New York has reported more than 4.1 million.

The United States has also hit an all-time high for hospitalizations, with nearly 146,000 COVID-19 patients in hospitals across the country, according to the latest data from the U.S. Department of Health and Human Services. The previous record was 142,000 hospitalizations in January 2021.

Jan. 11’s hospitalizations are more than twice as many as 2 weeks ago, according to CNN. About 78% of inpatient beds are in use nationwide, and 21% are being used for COVID-19 patients.

Deaths are averaging about 1,700 per day, Reuters reported, which is up from 1,400 in recent days but not much higher than earlier this winter. The peak average was 3,400 daily deaths in mid-January 2021.

The surging numbers of cases and hospitalizations across the country are straining hospitals. On Jan. 10, Virginia Gov. Ralph Northam declared a state of emergency after the number of intensive care unit hospitalizations more than doubled since Dec. 1, CNN reported. The order allows hospitals to expand bed capacity, use telehealth options, and be more flexible with staffing.

Texas is hiring at least 2,700 medical staff to help with the surge, CNN reported, and Kentucky has mobilized the National Guard to provide support.

“Omicron continues to burn through the commonwealth, growing at levels we have never seen before. Omicron is significantly more contagious than even the Delta variant,” Kentucky Gov. Andy Beshear said during a news briefing Jan. 10.

Kentucky reported its highest weekly total of cases last week and has its highest rate of positive tests, at 26%. Mr. Beshear said the state is down to 134 available adult ICU beds.

“If it spreads at the rate we are seeing, it is certainly going to fill up our hospitals,” he said.

A version of this article first appeared on WebMD.com.

The United States reported 1.35 million new COVID-19 cases on Jan. 10, logging the highest daily total for any country in the world during the pandemic.

The United States set the previous record of 1 million cases on Jan. 3. (A large number of cases are reported on Mondays, since many states don’t provide updates over the weekend, according to Reuters.)

Still, the 7-day average for new cases has surpassed 700,000, tripling in 2 weeks as the contagious Omicron variant continues to spread across the country.

The daily record of new cases came a day after the United States crossed the grim milestone of 60 million COVID-19 cases during the pandemic, according to the latest data from Johns Hopkins University. More than 11 million new cases were reported in the past 28 days, with 5 million reported since Jan. 2.

Globally, more than 310 million cases have been reported, resulting in nearly 5.5 million COVID-19 deaths. Almost 40 million cases have been confirmed worldwide during the past month, with the United States accounting for 28% of those.

Texas became the second state to report more than 5 million cases since the pandemic began, behind California’s total of 6 million cases. Florida has reported more than 4.6 million, while New York has reported more than 4.1 million.

The United States has also hit an all-time high for hospitalizations, with nearly 146,000 COVID-19 patients in hospitals across the country, according to the latest data from the U.S. Department of Health and Human Services. The previous record was 142,000 hospitalizations in January 2021.

Jan. 11’s hospitalizations are more than twice as many as 2 weeks ago, according to CNN. About 78% of inpatient beds are in use nationwide, and 21% are being used for COVID-19 patients.

Deaths are averaging about 1,700 per day, Reuters reported, which is up from 1,400 in recent days but not much higher than earlier this winter. The peak average was 3,400 daily deaths in mid-January 2021.

The surging numbers of cases and hospitalizations across the country are straining hospitals. On Jan. 10, Virginia Gov. Ralph Northam declared a state of emergency after the number of intensive care unit hospitalizations more than doubled since Dec. 1, CNN reported. The order allows hospitals to expand bed capacity, use telehealth options, and be more flexible with staffing.

Texas is hiring at least 2,700 medical staff to help with the surge, CNN reported, and Kentucky has mobilized the National Guard to provide support.

“Omicron continues to burn through the commonwealth, growing at levels we have never seen before. Omicron is significantly more contagious than even the Delta variant,” Kentucky Gov. Andy Beshear said during a news briefing Jan. 10.

Kentucky reported its highest weekly total of cases last week and has its highest rate of positive tests, at 26%. Mr. Beshear said the state is down to 134 available adult ICU beds.

“If it spreads at the rate we are seeing, it is certainly going to fill up our hospitals,” he said.

A version of this article first appeared on WebMD.com.

Lowering the serum urate target to less than 0.20 mmol/L (<3.6 mg/dL) for patients with erosive gout does not achieve better gout outcomes and leads to more medication use and subsequent side effects, according to findings from a 2-year, double-blind, randomized, controlled trial.

Nicola Dalbeth, MD, of the bone and joint research group, department of medicine, faculty of medical and health sciences at University of Auckland (New Zealand), and coauthors noted that intensive serum urate lowering is difficult to achieve with oral urate-lowering therapy (ULT) and their findings suggest lower is not always better.

Their data, published in Arthritis & Rheumatology, suggest the less-intensive standard target of less than 0.30 mmol/L (<5.4 mg/dL), currently recommended by rheumatology guidelines, is sufficient.

The more intensive target leads to a high medication burden and does not improve bone erosion score in erosive gout, the authors found.

Rheumatologist Angelo Gaffo, MD, associate professor of medicine at the University of Alabama at Birmingham, who was not part of the study, said erosion scores are the best way to test outcomes and this study provides support for current gout treatment approaches.

“It is reassuring that the approach of treating to target is a good approach,” Dr. Gaffo said. “The very, very low targets were not better than the [standard target].”

The trial included 104 participants with erosive gout on oral ULT who were randomized either to a serum urate target of less than 0.20 mmol/L or less than 0.30 mmol/L.

Ninety participants completed the study: 44 (85%) in the intensive target group and 46 (88%) in the standard target group. All were included in the primary intention-to-treat analysis. Participants were mostly men with an average age of 61. Average period of disease was 19 years and about half had a gout flare in the 3 months before enrollment in the study.
 

Fewer in intensive group hit target

The researchers found that serum urate at year 2 was significantly lower in the intensive target group, compared with the level in the standard target group (P = .002), but fewer participants in the intensive group hit their target, compared with those in the standard group (62% vs. 83%; P < .05).

The intensive group also required more medication. Participants in that group needed higher doses of the first-line treatment allopurinol (mean, 746 mg/day vs. 496 mg/day; P < .001). They also used more combination therapy (P = .0004).

Bone erosion scores were slightly better in both groups over 2 years, but there was no between-group difference (P = .20).

Rates of adverse and serious adverse events were similar between the groups.

The authors noted that a previous study has shown that escalating doses of allopurinol to achieve a target lower than 0.36 mmol/L (6.48 mg/dL) can reduce progression of bone erosion in gout.

“However, improved erosion scores were not observed in this study,” the authors noted.

The authors said that emerging data on intensive serum urate lowering “may lead to erosion healing in gout,” particularly with pegloticase (Krystexxa), a treatment that leads to profound reductions in serum urate.

They highlighted a small longitudinal study of patients treated with pegloticase in whom researchers observed the filling in of bone erosions over a year.
 

Pegloticase not available outside United States

However, the authors explained, use of pegloticase is unlikely to be widespread for erosive gout because of its lack of availability outside the United States and the need for infusions every 2 weeks. Therefore, more feasible strategies are needed.

Guidelines suggest the serum urate target of less than 0.30 mmol/L (5.4 mg/dL) for people with severe gout, including those with chronic arthropathy.
 

Managing gout is a long-term process

Herbert S.B. Baraf, MD, a rheumatologist in a large group practice in the Washington, D.C., area and clinical professor of medicine at George Washington University, Washington, who was not part of this study, said he would not come to the conclusion that some cynics might draw that there’s no point in trying to continually lower uric acid.

“Managing gout is a long-term proposition, and the long-term benefit of continuous uric acid lowering continue to accumulate over a period of time,” Dr. Baraf said.

He agreed with Dr. Dalbeth and colleagues that trying to get serum uric acid to less than 0.20 mmol/L is very difficult to achieve with oral drugs.

He said: “The study was not able to show a change in erosions because the amount of uric acid lowering wasn’t profound enough over a short enough period of time to show that, but over a longer period of time it might well show that.”

He said oral therapies work more slowly than enzyme-based therapies, such as pegloticase, but agreed there are barriers to using pegloticase.

“A drug like pegloticase costs about $26,000 per infusion every 2 weeks for a 6-month period. It’s not practical, and we tend to use it for people who are severely functionally impaired,” said Dr. Baraf.

It would still be a goal to keep the arthritis from progressing by using oral therapies, he said.

“I wouldn’t denigrate the fact that oral therapies are effective in decreasing flares over time, decreasing tophaceous deposits and probably – over a longer period of time allowing bone to heal. But 2 years is not enough time to show that.” He said showing benefit on erosions may take 5-10 years instead.

The study authors noted that the trial’s results “are not relevant to those without erosive disease, and to health care systems without access to a broad range of urate-lowering agents.”

Dr. Dalbeth reports personal fees (all less than $10,000) from AstraZeneca, Dyve BioSciences, Selecta, Arthrosi, Horizon, AbbVie, JW Pharmaceuticals, and PK Med outside the submitted work. The other authors have no disclosures. Dr. Gaffo reported no relevant financial relationships. Dr. Baraf has been an investigator/consultant and speaker for Horizon Therapeutics, maker of pegloticase; is an investigator and a consultant to Selecta Biosciences; and has been an investigator, speaker, and consultant for Takeda.

Lowering the serum urate target to less than 0.20 mmol/L (<3.6 mg/dL) for patients with erosive gout does not achieve better gout outcomes and leads to more medication use and subsequent side effects, according to findings from a 2-year, double-blind, randomized, controlled trial.

Nicola Dalbeth, MD, of the bone and joint research group, department of medicine, faculty of medical and health sciences at University of Auckland (New Zealand), and coauthors noted that intensive serum urate lowering is difficult to achieve with oral urate-lowering therapy (ULT) and their findings suggest lower is not always better.

Their data, published in Arthritis & Rheumatology, suggest the less-intensive standard target of less than 0.30 mmol/L (<5.4 mg/dL), currently recommended by rheumatology guidelines, is sufficient.

The more intensive target leads to a high medication burden and does not improve bone erosion score in erosive gout, the authors found.

Rheumatologist Angelo Gaffo, MD, associate professor of medicine at the University of Alabama at Birmingham, who was not part of the study, said erosion scores are the best way to test outcomes and this study provides support for current gout treatment approaches.

“It is reassuring that the approach of treating to target is a good approach,” Dr. Gaffo said. “The very, very low targets were not better than the [standard target].”

The trial included 104 participants with erosive gout on oral ULT who were randomized either to a serum urate target of less than 0.20 mmol/L or less than 0.30 mmol/L.

Ninety participants completed the study: 44 (85%) in the intensive target group and 46 (88%) in the standard target group. All were included in the primary intention-to-treat analysis. Participants were mostly men with an average age of 61. Average period of disease was 19 years and about half had a gout flare in the 3 months before enrollment in the study.
 

Fewer in intensive group hit target

The researchers found that serum urate at year 2 was significantly lower in the intensive target group, compared with the level in the standard target group (P = .002), but fewer participants in the intensive group hit their target, compared with those in the standard group (62% vs. 83%; P < .05).

The intensive group also required more medication. Participants in that group needed higher doses of the first-line treatment allopurinol (mean, 746 mg/day vs. 496 mg/day; P < .001). They also used more combination therapy (P = .0004).

Bone erosion scores were slightly better in both groups over 2 years, but there was no between-group difference (P = .20).

Rates of adverse and serious adverse events were similar between the groups.

The authors noted that a previous study has shown that escalating doses of allopurinol to achieve a target lower than 0.36 mmol/L (6.48 mg/dL) can reduce progression of bone erosion in gout.

“However, improved erosion scores were not observed in this study,” the authors noted.

The authors said that emerging data on intensive serum urate lowering “may lead to erosion healing in gout,” particularly with pegloticase (Krystexxa), a treatment that leads to profound reductions in serum urate.

They highlighted a small longitudinal study of patients treated with pegloticase in whom researchers observed the filling in of bone erosions over a year.
 

Pegloticase not available outside United States

However, the authors explained, use of pegloticase is unlikely to be widespread for erosive gout because of its lack of availability outside the United States and the need for infusions every 2 weeks. Therefore, more feasible strategies are needed.

Guidelines suggest the serum urate target of less than 0.30 mmol/L (5.4 mg/dL) for people with severe gout, including those with chronic arthropathy.
 

Managing gout is a long-term process

Herbert S.B. Baraf, MD, a rheumatologist in a large group practice in the Washington, D.C., area and clinical professor of medicine at George Washington University, Washington, who was not part of this study, said he would not come to the conclusion that some cynics might draw that there’s no point in trying to continually lower uric acid.

“Managing gout is a long-term proposition, and the long-term benefit of continuous uric acid lowering continue to accumulate over a period of time,” Dr. Baraf said.

He agreed with Dr. Dalbeth and colleagues that trying to get serum uric acid to less than 0.20 mmol/L is very difficult to achieve with oral drugs.

He said: “The study was not able to show a change in erosions because the amount of uric acid lowering wasn’t profound enough over a short enough period of time to show that, but over a longer period of time it might well show that.”

He said oral therapies work more slowly than enzyme-based therapies, such as pegloticase, but agreed there are barriers to using pegloticase.

“A drug like pegloticase costs about $26,000 per infusion every 2 weeks for a 6-month period. It’s not practical, and we tend to use it for people who are severely functionally impaired,” said Dr. Baraf.

It would still be a goal to keep the arthritis from progressing by using oral therapies, he said.

“I wouldn’t denigrate the fact that oral therapies are effective in decreasing flares over time, decreasing tophaceous deposits and probably – over a longer period of time allowing bone to heal. But 2 years is not enough time to show that.” He said showing benefit on erosions may take 5-10 years instead.

The study authors noted that the trial’s results “are not relevant to those without erosive disease, and to health care systems without access to a broad range of urate-lowering agents.”

Dr. Dalbeth reports personal fees (all less than $10,000) from AstraZeneca, Dyve BioSciences, Selecta, Arthrosi, Horizon, AbbVie, JW Pharmaceuticals, and PK Med outside the submitted work. The other authors have no disclosures. Dr. Gaffo reported no relevant financial relationships. Dr. Baraf has been an investigator/consultant and speaker for Horizon Therapeutics, maker of pegloticase; is an investigator and a consultant to Selecta Biosciences; and has been an investigator, speaker, and consultant for Takeda.

Lowering the serum urate target to less than 0.20 mmol/L (<3.6 mg/dL) for patients with erosive gout does not achieve better gout outcomes and leads to more medication use and subsequent side effects, according to findings from a 2-year, double-blind, randomized, controlled trial.

Nicola Dalbeth, MD, of the bone and joint research group, department of medicine, faculty of medical and health sciences at University of Auckland (New Zealand), and coauthors noted that intensive serum urate lowering is difficult to achieve with oral urate-lowering therapy (ULT) and their findings suggest lower is not always better.

Their data, published in Arthritis & Rheumatology, suggest the less-intensive standard target of less than 0.30 mmol/L (<5.4 mg/dL), currently recommended by rheumatology guidelines, is sufficient.

The more intensive target leads to a high medication burden and does not improve bone erosion score in erosive gout, the authors found.

Rheumatologist Angelo Gaffo, MD, associate professor of medicine at the University of Alabama at Birmingham, who was not part of the study, said erosion scores are the best way to test outcomes and this study provides support for current gout treatment approaches.

“It is reassuring that the approach of treating to target is a good approach,” Dr. Gaffo said. “The very, very low targets were not better than the [standard target].”

The trial included 104 participants with erosive gout on oral ULT who were randomized either to a serum urate target of less than 0.20 mmol/L or less than 0.30 mmol/L.

Ninety participants completed the study: 44 (85%) in the intensive target group and 46 (88%) in the standard target group. All were included in the primary intention-to-treat analysis. Participants were mostly men with an average age of 61. Average period of disease was 19 years and about half had a gout flare in the 3 months before enrollment in the study.
 

Fewer in intensive group hit target

The researchers found that serum urate at year 2 was significantly lower in the intensive target group, compared with the level in the standard target group (P = .002), but fewer participants in the intensive group hit their target, compared with those in the standard group (62% vs. 83%; P < .05).

The intensive group also required more medication. Participants in that group needed higher doses of the first-line treatment allopurinol (mean, 746 mg/day vs. 496 mg/day; P < .001). They also used more combination therapy (P = .0004).

Bone erosion scores were slightly better in both groups over 2 years, but there was no between-group difference (P = .20).

Rates of adverse and serious adverse events were similar between the groups.

The authors noted that a previous study has shown that escalating doses of allopurinol to achieve a target lower than 0.36 mmol/L (6.48 mg/dL) can reduce progression of bone erosion in gout.

“However, improved erosion scores were not observed in this study,” the authors noted.

The authors said that emerging data on intensive serum urate lowering “may lead to erosion healing in gout,” particularly with pegloticase (Krystexxa), a treatment that leads to profound reductions in serum urate.

They highlighted a small longitudinal study of patients treated with pegloticase in whom researchers observed the filling in of bone erosions over a year.
 

Pegloticase not available outside United States

However, the authors explained, use of pegloticase is unlikely to be widespread for erosive gout because of its lack of availability outside the United States and the need for infusions every 2 weeks. Therefore, more feasible strategies are needed.

Guidelines suggest the serum urate target of less than 0.30 mmol/L (5.4 mg/dL) for people with severe gout, including those with chronic arthropathy.
 

Managing gout is a long-term process

Herbert S.B. Baraf, MD, a rheumatologist in a large group practice in the Washington, D.C., area and clinical professor of medicine at George Washington University, Washington, who was not part of this study, said he would not come to the conclusion that some cynics might draw that there’s no point in trying to continually lower uric acid.

“Managing gout is a long-term proposition, and the long-term benefit of continuous uric acid lowering continue to accumulate over a period of time,” Dr. Baraf said.

He agreed with Dr. Dalbeth and colleagues that trying to get serum uric acid to less than 0.20 mmol/L is very difficult to achieve with oral drugs.

He said: “The study was not able to show a change in erosions because the amount of uric acid lowering wasn’t profound enough over a short enough period of time to show that, but over a longer period of time it might well show that.”

He said oral therapies work more slowly than enzyme-based therapies, such as pegloticase, but agreed there are barriers to using pegloticase.

“A drug like pegloticase costs about $26,000 per infusion every 2 weeks for a 6-month period. It’s not practical, and we tend to use it for people who are severely functionally impaired,” said Dr. Baraf.

It would still be a goal to keep the arthritis from progressing by using oral therapies, he said.

“I wouldn’t denigrate the fact that oral therapies are effective in decreasing flares over time, decreasing tophaceous deposits and probably – over a longer period of time allowing bone to heal. But 2 years is not enough time to show that.” He said showing benefit on erosions may take 5-10 years instead.

The study authors noted that the trial’s results “are not relevant to those without erosive disease, and to health care systems without access to a broad range of urate-lowering agents.”

Dr. Dalbeth reports personal fees (all less than $10,000) from AstraZeneca, Dyve BioSciences, Selecta, Arthrosi, Horizon, AbbVie, JW Pharmaceuticals, and PK Med outside the submitted work. The other authors have no disclosures. Dr. Gaffo reported no relevant financial relationships. Dr. Baraf has been an investigator/consultant and speaker for Horizon Therapeutics, maker of pegloticase; is an investigator and a consultant to Selecta Biosciences; and has been an investigator, speaker, and consultant for Takeda.

In early January, Ohio not only set a state record for COVID-19 hospitalizations—it had the fourth highest rate in the country, with 6,747 hospitalized coronavirus patients on January 10, a 40% increase over the previous 21 days. Most were unvaccinated. To help overwhelmed hospitals cope, Ohio Gov. Mike DeWine turned to the National Guard. Unfortunately, nearly half of the Ohio National Guard also were unvaccinated.

By US Department of Defense (DoD) directive, National Guard members must have a COVID-19 vaccination to be deployed on hospital missions. Thus, in COVID hotspots across the nation, governors are on the horns of a dilemma. They want and need to deploy the National Guard to give medical and nonclinical support but aren’t sure whether they will be able to or, indeed, whether they should.

So far, vaccinated teams are already on the ground in a number of states. In Indiana, where hospitalizations jumped 50% over 2 weeks in December, the National Guard sent 6-person teams, all fully vaccinated. In New Hampshire, 70 guards are being deployed to help hospitals with food service, clerical work, and other nonmedical functions. New York Governor Kathy Hochul has deployed guard members for help to ease the strain on nursing homes. Massachusetts Governor Charlie Baker has activated up to 500 guard members; some will be supporting 55 acute care hospital and 12 ambulance services. In Maine, where cases have peaked, Governor Janet Mills activated guard members to support nursing facilities and administer monoclonal antibodies. The Louisiana National Guard has administered more than 542,000 COVID-19 tests and 206,300 vaccines. As many as 1,000 Maryland Air and Army National Guardsmen are being activated to help with testing and other missions.

However, as in Ohio, other states are facing problematic scenarios. For instance, about 40% of the more than 20,000 Texas National Guard are refusing to get vaccinated, challenging the Biden Administration vaccine requirement for all military.

And a court showdown over federal vaccine mandates, started by Governor Kevin Stitt of Oklahoma and joined by the Republican governors of Wyoming, Iowa, Alaska, Nebraska, and Mississippi, came to a head in December. Last November, Stitt asked Defense Secretary Lloyd Austin to exempt Oklahoma’s National Guard from the vaccine mandate. He claimed the requirement violated the personal freedoms of many Oklahomans and could cause them to “potentially sacrifice their personal beliefs.” But in a memo to the Joint Chiefs chairmen, the service secretaries and the head of the National Guard Bureau, Austin wrote that Pentagon funds could not be used to pay for duties performed under Title 32 for members of the Guard who do not comply with the military’s vaccine requirement. (Title 32 refers to Guard operations under state orders.) Austin also said National Guard members must be vaccinated to participate in drills, training, and other duty conducted under Title 32.

Stitt, maintaining that he is commander in chief of the Oklahoma National Guard as long as it operates under Title 32 orders, put out his own memo stipulating that no Guard member was required to get vaccinated. He also ordered Brig. Gen. Thomas Mancino, newly appointed commander of the Oklahoma National Guard, to not enforce the mandate. Subsequently, Mancino issued a statement pointing out that current state law is limited in protecting troops who opt out of the shot. Moreover, if the Guard were called up under federal orders, he said, he would enforce the mandate. Training events, schools, and mobilizations were going to “eventually force you out of that safe harbor,” he wrote, “…This is reality.”

In late December, a federal judge denied Oklahoma’s motion to enjoin the mandate. The Oklahoma Attorney General’s office responded, “We will not be surprised if the President’s vaccine mandate actually reduces the nation’s military readiness instead of promoting it.”

In a press briefing, Pentagon press secretary John Kirby said, “The Secretary has the authorities he needs to require this vaccine across the force, including the National Guard. …[E]ven when they’re in a Title 32 status.” He added, “It is a lawful order for National Guardsmen to receive the COVID vaccine. It’s a lawful order, and refusing to do that, absent of an improved exemption, puts them in the same potential [position] as active-duty members who refuse the vaccine.” That could mean, for instance, loss of pay and membership in the National Guard.

A core rationale for the mandate, according to Secretary Austin, is the need for military readiness—meaning Guard members must be healthy and fit for duty. And that extends to being healthy and fit for missions like transporting at-risk patients. Ohio National Guard Adjutant General Major General John Harris Jr. said, “I would never put a soldier or airman in harm’s way without the best protection we could put on them—body armor, helmets. And this medical readiness is the exact same thing. We’re putting folks into harm’s way.” He has moved the deadline from the Pentagon’s June 30 date to March 31—a move that boosted the vaccination rate from 53% to 56% in one week.

Ohio Governor DeWine has expressed frustration that almost half of the Ohio Army National Guard personnel can’t be deployed on this mission because they’re unvaccinated. “In some of our testing places, 40 to 50% of the people are testing positive,” he said. “So this is a high-risk operation. You need to be protected. The best way for you to be protected is to get the vaccination.”

As of December 2021, according to the National Guard Bureau, the National Guard as a whole was 66% fully vaccinated. The percentages vary according to service; for instance, nearly 90% of airmen have been vaccinated, compared with only 40% of Army Guardsmen. Among the states challenging the mandate, the vaccinated rates have been moving upward: In Alaska, about 92% of the Air National Guard have been vaccinated—leaving roughly 11,000 troops who had not met the December 2 deadline. In Iowa, as of Nov. 30, 91% of Air National Guard and 80% of Army National Guard members had been vaccinated, but about 9,000 soldiers had been directed to get the vaccination or risk disciplinary action. Almost 2,200 of the more than 2,800-strong Wyoming National Guard (77%) have received at least 1 dose. Nebraska Air National Guard’s force of 1,000 was 94% fully vaccinated as of December 1. (Maj Scott Ingalsbe, public affairs officer, said, “Vaccinations are tied to individual medical readiness. They provide service members with the best protection available so they can perform missions across the globe.”).

In most states, Army National Guard members have until June 30, 2022, to comply. “Our soldiers …have until [the DoD’s deadline], and some of them are just going to wait close to the deadline,” John Goheen of the National Guard Association of the United States said in a discussion on NPR. “That’s human nature.”

Earlier this month, Texas Governor Greg Abbott told National Guard members they can ignore the Pentagon’s COVID-19 vaccine mandate: “President Biden is not your commander-in-chief.” He has also sued the Biden administration over the requirement.

In the meantime, the hospitals at breaking point must hope for the best and take as much help as they can get. 

In early January, Ohio not only set a state record for COVID-19 hospitalizations—it had the fourth highest rate in the country, with 6,747 hospitalized coronavirus patients on January 10, a 40% increase over the previous 21 days. Most were unvaccinated. To help overwhelmed hospitals cope, Ohio Gov. Mike DeWine turned to the National Guard. Unfortunately, nearly half of the Ohio National Guard also were unvaccinated.

By US Department of Defense (DoD) directive, National Guard members must have a COVID-19 vaccination to be deployed on hospital missions. Thus, in COVID hotspots across the nation, governors are on the horns of a dilemma. They want and need to deploy the National Guard to give medical and nonclinical support but aren’t sure whether they will be able to or, indeed, whether they should.

So far, vaccinated teams are already on the ground in a number of states. In Indiana, where hospitalizations jumped 50% over 2 weeks in December, the National Guard sent 6-person teams, all fully vaccinated. In New Hampshire, 70 guards are being deployed to help hospitals with food service, clerical work, and other nonmedical functions. New York Governor Kathy Hochul has deployed guard members for help to ease the strain on nursing homes. Massachusetts Governor Charlie Baker has activated up to 500 guard members; some will be supporting 55 acute care hospital and 12 ambulance services. In Maine, where cases have peaked, Governor Janet Mills activated guard members to support nursing facilities and administer monoclonal antibodies. The Louisiana National Guard has administered more than 542,000 COVID-19 tests and 206,300 vaccines. As many as 1,000 Maryland Air and Army National Guardsmen are being activated to help with testing and other missions.

However, as in Ohio, other states are facing problematic scenarios. For instance, about 40% of the more than 20,000 Texas National Guard are refusing to get vaccinated, challenging the Biden Administration vaccine requirement for all military.

And a court showdown over federal vaccine mandates, started by Governor Kevin Stitt of Oklahoma and joined by the Republican governors of Wyoming, Iowa, Alaska, Nebraska, and Mississippi, came to a head in December. Last November, Stitt asked Defense Secretary Lloyd Austin to exempt Oklahoma’s National Guard from the vaccine mandate. He claimed the requirement violated the personal freedoms of many Oklahomans and could cause them to “potentially sacrifice their personal beliefs.” But in a memo to the Joint Chiefs chairmen, the service secretaries and the head of the National Guard Bureau, Austin wrote that Pentagon funds could not be used to pay for duties performed under Title 32 for members of the Guard who do not comply with the military’s vaccine requirement. (Title 32 refers to Guard operations under state orders.) Austin also said National Guard members must be vaccinated to participate in drills, training, and other duty conducted under Title 32.

Stitt, maintaining that he is commander in chief of the Oklahoma National Guard as long as it operates under Title 32 orders, put out his own memo stipulating that no Guard member was required to get vaccinated. He also ordered Brig. Gen. Thomas Mancino, newly appointed commander of the Oklahoma National Guard, to not enforce the mandate. Subsequently, Mancino issued a statement pointing out that current state law is limited in protecting troops who opt out of the shot. Moreover, if the Guard were called up under federal orders, he said, he would enforce the mandate. Training events, schools, and mobilizations were going to “eventually force you out of that safe harbor,” he wrote, “…This is reality.”

In late December, a federal judge denied Oklahoma’s motion to enjoin the mandate. The Oklahoma Attorney General’s office responded, “We will not be surprised if the President’s vaccine mandate actually reduces the nation’s military readiness instead of promoting it.”

In a press briefing, Pentagon press secretary John Kirby said, “The Secretary has the authorities he needs to require this vaccine across the force, including the National Guard. …[E]ven when they’re in a Title 32 status.” He added, “It is a lawful order for National Guardsmen to receive the COVID vaccine. It’s a lawful order, and refusing to do that, absent of an improved exemption, puts them in the same potential [position] as active-duty members who refuse the vaccine.” That could mean, for instance, loss of pay and membership in the National Guard.

A core rationale for the mandate, according to Secretary Austin, is the need for military readiness—meaning Guard members must be healthy and fit for duty. And that extends to being healthy and fit for missions like transporting at-risk patients. Ohio National Guard Adjutant General Major General John Harris Jr. said, “I would never put a soldier or airman in harm’s way without the best protection we could put on them—body armor, helmets. And this medical readiness is the exact same thing. We’re putting folks into harm’s way.” He has moved the deadline from the Pentagon’s June 30 date to March 31—a move that boosted the vaccination rate from 53% to 56% in one week.

Ohio Governor DeWine has expressed frustration that almost half of the Ohio Army National Guard personnel can’t be deployed on this mission because they’re unvaccinated. “In some of our testing places, 40 to 50% of the people are testing positive,” he said. “So this is a high-risk operation. You need to be protected. The best way for you to be protected is to get the vaccination.”

As of December 2021, according to the National Guard Bureau, the National Guard as a whole was 66% fully vaccinated. The percentages vary according to service; for instance, nearly 90% of airmen have been vaccinated, compared with only 40% of Army Guardsmen. Among the states challenging the mandate, the vaccinated rates have been moving upward: In Alaska, about 92% of the Air National Guard have been vaccinated—leaving roughly 11,000 troops who had not met the December 2 deadline. In Iowa, as of Nov. 30, 91% of Air National Guard and 80% of Army National Guard members had been vaccinated, but about 9,000 soldiers had been directed to get the vaccination or risk disciplinary action. Almost 2,200 of the more than 2,800-strong Wyoming National Guard (77%) have received at least 1 dose. Nebraska Air National Guard’s force of 1,000 was 94% fully vaccinated as of December 1. (Maj Scott Ingalsbe, public affairs officer, said, “Vaccinations are tied to individual medical readiness. They provide service members with the best protection available so they can perform missions across the globe.”).

In most states, Army National Guard members have until June 30, 2022, to comply. “Our soldiers …have until [the DoD’s deadline], and some of them are just going to wait close to the deadline,” John Goheen of the National Guard Association of the United States said in a discussion on NPR. “That’s human nature.”

Earlier this month, Texas Governor Greg Abbott told National Guard members they can ignore the Pentagon’s COVID-19 vaccine mandate: “President Biden is not your commander-in-chief.” He has also sued the Biden administration over the requirement.

In the meantime, the hospitals at breaking point must hope for the best and take as much help as they can get. 

In early January, Ohio not only set a state record for COVID-19 hospitalizations—it had the fourth highest rate in the country, with 6,747 hospitalized coronavirus patients on January 10, a 40% increase over the previous 21 days. Most were unvaccinated. To help overwhelmed hospitals cope, Ohio Gov. Mike DeWine turned to the National Guard. Unfortunately, nearly half of the Ohio National Guard also were unvaccinated.

By US Department of Defense (DoD) directive, National Guard members must have a COVID-19 vaccination to be deployed on hospital missions. Thus, in COVID hotspots across the nation, governors are on the horns of a dilemma. They want and need to deploy the National Guard to give medical and nonclinical support but aren’t sure whether they will be able to or, indeed, whether they should.

So far, vaccinated teams are already on the ground in a number of states. In Indiana, where hospitalizations jumped 50% over 2 weeks in December, the National Guard sent 6-person teams, all fully vaccinated. In New Hampshire, 70 guards are being deployed to help hospitals with food service, clerical work, and other nonmedical functions. New York Governor Kathy Hochul has deployed guard members for help to ease the strain on nursing homes. Massachusetts Governor Charlie Baker has activated up to 500 guard members; some will be supporting 55 acute care hospital and 12 ambulance services. In Maine, where cases have peaked, Governor Janet Mills activated guard members to support nursing facilities and administer monoclonal antibodies. The Louisiana National Guard has administered more than 542,000 COVID-19 tests and 206,300 vaccines. As many as 1,000 Maryland Air and Army National Guardsmen are being activated to help with testing and other missions.

However, as in Ohio, other states are facing problematic scenarios. For instance, about 40% of the more than 20,000 Texas National Guard are refusing to get vaccinated, challenging the Biden Administration vaccine requirement for all military.

And a court showdown over federal vaccine mandates, started by Governor Kevin Stitt of Oklahoma and joined by the Republican governors of Wyoming, Iowa, Alaska, Nebraska, and Mississippi, came to a head in December. Last November, Stitt asked Defense Secretary Lloyd Austin to exempt Oklahoma’s National Guard from the vaccine mandate. He claimed the requirement violated the personal freedoms of many Oklahomans and could cause them to “potentially sacrifice their personal beliefs.” But in a memo to the Joint Chiefs chairmen, the service secretaries and the head of the National Guard Bureau, Austin wrote that Pentagon funds could not be used to pay for duties performed under Title 32 for members of the Guard who do not comply with the military’s vaccine requirement. (Title 32 refers to Guard operations under state orders.) Austin also said National Guard members must be vaccinated to participate in drills, training, and other duty conducted under Title 32.

Stitt, maintaining that he is commander in chief of the Oklahoma National Guard as long as it operates under Title 32 orders, put out his own memo stipulating that no Guard member was required to get vaccinated. He also ordered Brig. Gen. Thomas Mancino, newly appointed commander of the Oklahoma National Guard, to not enforce the mandate. Subsequently, Mancino issued a statement pointing out that current state law is limited in protecting troops who opt out of the shot. Moreover, if the Guard were called up under federal orders, he said, he would enforce the mandate. Training events, schools, and mobilizations were going to “eventually force you out of that safe harbor,” he wrote, “…This is reality.”

In late December, a federal judge denied Oklahoma’s motion to enjoin the mandate. The Oklahoma Attorney General’s office responded, “We will not be surprised if the President’s vaccine mandate actually reduces the nation’s military readiness instead of promoting it.”

In a press briefing, Pentagon press secretary John Kirby said, “The Secretary has the authorities he needs to require this vaccine across the force, including the National Guard. …[E]ven when they’re in a Title 32 status.” He added, “It is a lawful order for National Guardsmen to receive the COVID vaccine. It’s a lawful order, and refusing to do that, absent of an improved exemption, puts them in the same potential [position] as active-duty members who refuse the vaccine.” That could mean, for instance, loss of pay and membership in the National Guard.

A core rationale for the mandate, according to Secretary Austin, is the need for military readiness—meaning Guard members must be healthy and fit for duty. And that extends to being healthy and fit for missions like transporting at-risk patients. Ohio National Guard Adjutant General Major General John Harris Jr. said, “I would never put a soldier or airman in harm’s way without the best protection we could put on them—body armor, helmets. And this medical readiness is the exact same thing. We’re putting folks into harm’s way.” He has moved the deadline from the Pentagon’s June 30 date to March 31—a move that boosted the vaccination rate from 53% to 56% in one week.

Ohio Governor DeWine has expressed frustration that almost half of the Ohio Army National Guard personnel can’t be deployed on this mission because they’re unvaccinated. “In some of our testing places, 40 to 50% of the people are testing positive,” he said. “So this is a high-risk operation. You need to be protected. The best way for you to be protected is to get the vaccination.”

As of December 2021, according to the National Guard Bureau, the National Guard as a whole was 66% fully vaccinated. The percentages vary according to service; for instance, nearly 90% of airmen have been vaccinated, compared with only 40% of Army Guardsmen. Among the states challenging the mandate, the vaccinated rates have been moving upward: In Alaska, about 92% of the Air National Guard have been vaccinated—leaving roughly 11,000 troops who had not met the December 2 deadline. In Iowa, as of Nov. 30, 91% of Air National Guard and 80% of Army National Guard members had been vaccinated, but about 9,000 soldiers had been directed to get the vaccination or risk disciplinary action. Almost 2,200 of the more than 2,800-strong Wyoming National Guard (77%) have received at least 1 dose. Nebraska Air National Guard’s force of 1,000 was 94% fully vaccinated as of December 1. (Maj Scott Ingalsbe, public affairs officer, said, “Vaccinations are tied to individual medical readiness. They provide service members with the best protection available so they can perform missions across the globe.”).

In most states, Army National Guard members have until June 30, 2022, to comply. “Our soldiers …have until [the DoD’s deadline], and some of them are just going to wait close to the deadline,” John Goheen of the National Guard Association of the United States said in a discussion on NPR. “That’s human nature.”

Earlier this month, Texas Governor Greg Abbott told National Guard members they can ignore the Pentagon’s COVID-19 vaccine mandate: “President Biden is not your commander-in-chief.” He has also sued the Biden administration over the requirement.

In the meantime, the hospitals at breaking point must hope for the best and take as much help as they can get. 

Combining high-risk human papillomavirus (hrHPV)–based screening with cytologic triage detected two times more cases of grade 2+ cervical intraepithelial neoplasia (CIN2+) than cytology alone, according to a new study.

The study, which analyzed data from Mexico’s population-based hrHPV screening program over 6 years, confirms the importance of HPV screening for catching high-grade cervical lesions early.

“Our results provide evidence that hrHPV testing is the best strategy for a timely diagnosis of CIN2+ lesions while avoiding overtreatment of young women,” the study authors write. “Many countries now use hrHPV testing as the primary screening method, given it has higher sensitivity and detects more cervical cancer precursor lesions, such as CIN2+.”

According to Erik Jansen, MSc, the analysis supports recent updates to U.S. screening standards and confirms findings from previous trials, which show that HPV testing significantly improves prevention of cervical cancer.

“The significance of this paper is that the data reported is from a long follow-up in a country that implemented HPV screening on a large scale,” Mr. Jansen, PhD candidate in the Department of Public Health, Erasmus University Medical Center, Rotterdam, the Netherlands, told this news organization.

The study, conducted by Mexico’s National Institute of Public Health, analyzed screening data from the country’s public cervical cancer prevention program from 2010 to 2015. More than 2 million women aged 34 to 65 who had hrHPV-based screening tests followed by cytologic triage if they were HPV positive were included, as were 2.8 million women of the same age who received cytologic testing alone.

In the hrHPV group, 1.2% of women (n = 24,276) received referrals to colposcopy versus 3.1% of women (n = 90,980) in the cytology group. And among all women, only 0.8% who had abnormal results (n = 16,459) in the HPV went for a colposcopy versus 1.5% (n = 43,638) in the cytology group.

Overall, the authors found that 13.3 colposcopies were required to detect a single CIN2+ case in the cytology group compared to 5.7 colposcopies in the hrHPV with cytologic triage group.

The authors also note that the cost of colposcopies was three times lower in the HPV testing group and that the positive predictive value of hrHPV testing with cytologic triage was 17.5% versus 7.5% for cytology alone.

“The positive predictive value did not change for either screening strategy whether or not women lost to follow-up were taken into account,” the authors write.

Although Mr. Jansen noted that the findings are important, he also pointed to several limitations – namely, the significant loss to follow-up in the HPV group.

The HPV testing and cytologic triage happened in separate visits, and under the two-visit protocol, more than 50% of women who tested positive for HPV didn’t return for cytology. Such a significant loss to follow-up may call some of the findings into question, Mr. Jansen noted.

For instance, the rate of colposcopy referrals does not account for HPV-positive women who skipped their cytology screening. Assuming the same HPV risk for women who received cytology and those who did not, Mr. Jansen calculated that without any loss to follow-up, the colposcopy referral rate would have increased from the reported 1.2% to 2.6%, which is much closer to the 3.1% of the women referred in the cytology arm.

The lower colposcopy costs in the HPV group were also likely due, in part, to the loss to follow-up, which is not necessarily a good thing, Mr. Jansen said.

Still, “this study does confirm the finding that a primary HPV screening program is more effective than cytology [alone],” Mr. Jansen said.

Co-author Eduardo Franco reported receiving grants and personal fees from MSD and has a pending patent, “Methylation Markers in Cervical Cancer.” All other authors reported no conflicts of interest.

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

Combining high-risk human papillomavirus (hrHPV)–based screening with cytologic triage detected two times more cases of grade 2+ cervical intraepithelial neoplasia (CIN2+) than cytology alone, according to a new study.

The study, which analyzed data from Mexico’s population-based hrHPV screening program over 6 years, confirms the importance of HPV screening for catching high-grade cervical lesions early.

“Our results provide evidence that hrHPV testing is the best strategy for a timely diagnosis of CIN2+ lesions while avoiding overtreatment of young women,” the study authors write. “Many countries now use hrHPV testing as the primary screening method, given it has higher sensitivity and detects more cervical cancer precursor lesions, such as CIN2+.”

According to Erik Jansen, MSc, the analysis supports recent updates to U.S. screening standards and confirms findings from previous trials, which show that HPV testing significantly improves prevention of cervical cancer.

“The significance of this paper is that the data reported is from a long follow-up in a country that implemented HPV screening on a large scale,” Mr. Jansen, PhD candidate in the Department of Public Health, Erasmus University Medical Center, Rotterdam, the Netherlands, told this news organization.

The study, conducted by Mexico’s National Institute of Public Health, analyzed screening data from the country’s public cervical cancer prevention program from 2010 to 2015. More than 2 million women aged 34 to 65 who had hrHPV-based screening tests followed by cytologic triage if they were HPV positive were included, as were 2.8 million women of the same age who received cytologic testing alone.

In the hrHPV group, 1.2% of women (n = 24,276) received referrals to colposcopy versus 3.1% of women (n = 90,980) in the cytology group. And among all women, only 0.8% who had abnormal results (n = 16,459) in the HPV went for a colposcopy versus 1.5% (n = 43,638) in the cytology group.

Overall, the authors found that 13.3 colposcopies were required to detect a single CIN2+ case in the cytology group compared to 5.7 colposcopies in the hrHPV with cytologic triage group.

The authors also note that the cost of colposcopies was three times lower in the HPV testing group and that the positive predictive value of hrHPV testing with cytologic triage was 17.5% versus 7.5% for cytology alone.

“The positive predictive value did not change for either screening strategy whether or not women lost to follow-up were taken into account,” the authors write.

Although Mr. Jansen noted that the findings are important, he also pointed to several limitations – namely, the significant loss to follow-up in the HPV group.

The HPV testing and cytologic triage happened in separate visits, and under the two-visit protocol, more than 50% of women who tested positive for HPV didn’t return for cytology. Such a significant loss to follow-up may call some of the findings into question, Mr. Jansen noted.

For instance, the rate of colposcopy referrals does not account for HPV-positive women who skipped their cytology screening. Assuming the same HPV risk for women who received cytology and those who did not, Mr. Jansen calculated that without any loss to follow-up, the colposcopy referral rate would have increased from the reported 1.2% to 2.6%, which is much closer to the 3.1% of the women referred in the cytology arm.

The lower colposcopy costs in the HPV group were also likely due, in part, to the loss to follow-up, which is not necessarily a good thing, Mr. Jansen said.

Still, “this study does confirm the finding that a primary HPV screening program is more effective than cytology [alone],” Mr. Jansen said.

Co-author Eduardo Franco reported receiving grants and personal fees from MSD and has a pending patent, “Methylation Markers in Cervical Cancer.” All other authors reported no conflicts of interest.

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

Combining high-risk human papillomavirus (hrHPV)–based screening with cytologic triage detected two times more cases of grade 2+ cervical intraepithelial neoplasia (CIN2+) than cytology alone, according to a new study.

The study, which analyzed data from Mexico’s population-based hrHPV screening program over 6 years, confirms the importance of HPV screening for catching high-grade cervical lesions early.

“Our results provide evidence that hrHPV testing is the best strategy for a timely diagnosis of CIN2+ lesions while avoiding overtreatment of young women,” the study authors write. “Many countries now use hrHPV testing as the primary screening method, given it has higher sensitivity and detects more cervical cancer precursor lesions, such as CIN2+.”

According to Erik Jansen, MSc, the analysis supports recent updates to U.S. screening standards and confirms findings from previous trials, which show that HPV testing significantly improves prevention of cervical cancer.

“The significance of this paper is that the data reported is from a long follow-up in a country that implemented HPV screening on a large scale,” Mr. Jansen, PhD candidate in the Department of Public Health, Erasmus University Medical Center, Rotterdam, the Netherlands, told this news organization.

The study, conducted by Mexico’s National Institute of Public Health, analyzed screening data from the country’s public cervical cancer prevention program from 2010 to 2015. More than 2 million women aged 34 to 65 who had hrHPV-based screening tests followed by cytologic triage if they were HPV positive were included, as were 2.8 million women of the same age who received cytologic testing alone.

In the hrHPV group, 1.2% of women (n = 24,276) received referrals to colposcopy versus 3.1% of women (n = 90,980) in the cytology group. And among all women, only 0.8% who had abnormal results (n = 16,459) in the HPV went for a colposcopy versus 1.5% (n = 43,638) in the cytology group.

Overall, the authors found that 13.3 colposcopies were required to detect a single CIN2+ case in the cytology group compared to 5.7 colposcopies in the hrHPV with cytologic triage group.

The authors also note that the cost of colposcopies was three times lower in the HPV testing group and that the positive predictive value of hrHPV testing with cytologic triage was 17.5% versus 7.5% for cytology alone.

“The positive predictive value did not change for either screening strategy whether or not women lost to follow-up were taken into account,” the authors write.

Although Mr. Jansen noted that the findings are important, he also pointed to several limitations – namely, the significant loss to follow-up in the HPV group.

The HPV testing and cytologic triage happened in separate visits, and under the two-visit protocol, more than 50% of women who tested positive for HPV didn’t return for cytology. Such a significant loss to follow-up may call some of the findings into question, Mr. Jansen noted.

For instance, the rate of colposcopy referrals does not account for HPV-positive women who skipped their cytology screening. Assuming the same HPV risk for women who received cytology and those who did not, Mr. Jansen calculated that without any loss to follow-up, the colposcopy referral rate would have increased from the reported 1.2% to 2.6%, which is much closer to the 3.1% of the women referred in the cytology arm.

The lower colposcopy costs in the HPV group were also likely due, in part, to the loss to follow-up, which is not necessarily a good thing, Mr. Jansen said.

Still, “this study does confirm the finding that a primary HPV screening program is more effective than cytology [alone],” Mr. Jansen said.

Co-author Eduardo Franco reported receiving grants and personal fees from MSD and has a pending patent, “Methylation Markers in Cervical Cancer.” All other authors reported no conflicts of interest.

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

A new, augmented autism-screening strategy boosted the number of boys diagnosed with the condition, especially Spanish speakers, a new study finds. The research was published in JAMA Pediatrics

The number of diagnoses in girls didn’t budge significantly, however, surprising researchers. Still, the findings suggest that “multistage screening and appropriate access to diagnostic services can really move the needle on the early detection of autism and reducing disparities in autism diagnosis and detection,” said lead author R. Christopher Sheldrick, PhD, a Boston University research associate professor of health law, policy, and management, in an interview.

While early intervention is considered crucial, U.S. research suggests that several groups of children – the poor, racial and ethnic minorities, and non-English speakers – are more likely to be diagnosed with autism spectrum disorder (ASD) later in life. “They have much lower access to appropriate services, both to get kids diagnosed and to get the kinds of interventions that can be helpful for families,” Dr. Sheldrick said. “Our study is about trying to close the gap around diagnosis, the first step.”

For the new study, the researchers implemented an intervention strategy in Massachusetts at three Early Intervention (EI) programs, which provide autism screening to children who are referred by pediatricians or parents. The researchers then tracked the programs, all in Boston, and nine comparison programs from the greater Boston area from 2012 to 2018.

Overall, 33,326 children were assessed, all aged 14-36 months. Those at the intervention programs were chosen because they had high levels of poverty. Children at those programs were more likely to be Black than those at the comparison programs (30.7% vs. 12.2%), to be Spanish speakers (28.9% vs. 12.5%), and to be in the lowest household income bracket (66.9% vs. 54.2%). In both groups, about 64% of the children were male.

The intervention strategy aimed to reduce the reliance on screening tests. Instead, the study authors write, “our protocol emphasizes ASD screening as a process that includes clinician and parent decision-making.”

As Dr. Sheldrick explained, parents and specialists observe children together “and then decide whether it’s worth taking the next step, which is a full diagnostic assessment with a licensed professional.” According to the study, either the parent(s) or the specialists could make the referral for a full, university-based assessment.

The goal was to help specialists use their professional judgment more, he said, and refer children who don’t show signs of ASD via a screening instrument but still spark concern, he said. “We’re really trying to create a system in which the screening tools support professional judgment, but don’t really replace it.”

After weighting, the researchers found that diagnoses of ASD were more common in the intervention sites vs. comparison sites (incidence rate ratio, 1.6; 95% confidence interval, 1.3-2.1, P < .001), accounting for an extra 8.1 diagnoses per 1,000 per quarter. Among Spanish-speaking families only, diagnoses grew even more in the intervention sites vs. comparison sites (IRR, 2.6; 95% CI, 1.6-4.3; P < .001), representing 15.4 additional diagnoses per 1,000 children per quarter.

There was also an increase in diagnoses among boys in the intervention sites vs. comparison sites (IRR, 1.8; 95% CI, 1.4-2.3; P < .001), accounting for 14.8 additional diagnoses per 1,000 children per quarter. However, there was no statistically significant increase in diagnosis among girls (IRR, 1.1; 95% CI, 0.6-1.7; P = .84).

The finding about girls surprised the researchers. “The program was highly effective for boys, but really didn’t have any effect for girls,” Dr. Sheldrick said. “Even though autism is considered to be more common in boys, there are questions about whether it’s underidentified in girls. These data would be consistent with that view. So there’s work to do to be able to recognize how a young girl with autism might present and how you might note that in a sensitive way and then respond appropriately.”

The overall message of the study is “that screening with appropriate supports can make a difference,” he said. However, he acknowledged that the extra cost of the program is unclear. “We did not systematically collect data on cost,” he said, noting that the funding for the study paid for both the intervention and the analysis.

For now, he said, researchers are following the children in the study to see if they were able to access treatment services. Some of the investigators are also taking part in a randomized study to evaluate an intervention in children with social communication disorders, he said.

In an accompanying commentary, three pediatric specialists noted that the study is the first to analyze ASD screening in EI. “This study supports the notion of ASD screening as an iterative, multistep process that optimally involves multiple community stakeholders with varying levels of developmental expertise who have done the work to build trust with families,” write pediatrician Kate E. Wallis, MD, MPH, of Children’s Hospital of Philadelphia, graduate student Monica M. Abdul-Chani, MA, of the University of Alabama at Birmingham, and pediatrician Katharine E. Zuckerman, MD, MPH, of Oregon Health & Science University, Portland.

In regard to disparities in diagnosis in Spanish-speaking families, the commentary authors write that “locating a greater proportion of the ASD identification process in EI, which families are already familiar with, has no to low cost for families, and is likely geographically closer for families, can reduce structural barriers to identification.”

They add that the emphasis within Latino families on the “building of warm and caring relationships with others based on mutual trust and respect” can allow EI specialists to “develop relationships with families who may be afraid or skeptical of sharing what could be considered personal details of their family life.”

The commentary authors also note that “it remains all too common for language delays to be attributed to child exposure to two languages, even though data do not support this attribution. Bilingual EI staff can help to demystify this perpetual myth and better estimate a child’s communication and social skills in both languages as they communicate and play.”

The study was funded by grants from the Health Resources Services Administration and the National Institute of Mental Health. Dr. Sheldrick is cocreator of the Parent’s Observations of Social Interaction (POSI), which is one of the two first-stage screeners used in this study. He conducts research related to this instrument but receives no royalties. He reports grants from the National Institutes of Health. Coauthor Alice S. Carter, PhD, is cocreator of the POSI but receives no royalties. She is also cocreator of the Brief Infant Toddler Social Emotional Assessment, which is one of the two first-stage screeners used in this study, and receives royalties on the sale of the instrument. She reports grants from the National Institutes of Health and the Health Resources and Services Administration. Study coauthor Thomas I. Mackie, PhD, MPH, reports grants from the National Institute of Mental Health. Study coauthor Noah Hoch reports grants from the Health Resources Services Administration and the National Institute of Mental Health. No other disclosures from study authors are reported. Dr. Zuckerman reported grants from the National Institutes of Health and National Institute of Mental Health and consulting fees from H2N related to autism. The other commentary authors report no disclosures.

A new, augmented autism-screening strategy boosted the number of boys diagnosed with the condition, especially Spanish speakers, a new study finds. The research was published in JAMA Pediatrics

The number of diagnoses in girls didn’t budge significantly, however, surprising researchers. Still, the findings suggest that “multistage screening and appropriate access to diagnostic services can really move the needle on the early detection of autism and reducing disparities in autism diagnosis and detection,” said lead author R. Christopher Sheldrick, PhD, a Boston University research associate professor of health law, policy, and management, in an interview.

While early intervention is considered crucial, U.S. research suggests that several groups of children – the poor, racial and ethnic minorities, and non-English speakers – are more likely to be diagnosed with autism spectrum disorder (ASD) later in life. “They have much lower access to appropriate services, both to get kids diagnosed and to get the kinds of interventions that can be helpful for families,” Dr. Sheldrick said. “Our study is about trying to close the gap around diagnosis, the first step.”

For the new study, the researchers implemented an intervention strategy in Massachusetts at three Early Intervention (EI) programs, which provide autism screening to children who are referred by pediatricians or parents. The researchers then tracked the programs, all in Boston, and nine comparison programs from the greater Boston area from 2012 to 2018.

Overall, 33,326 children were assessed, all aged 14-36 months. Those at the intervention programs were chosen because they had high levels of poverty. Children at those programs were more likely to be Black than those at the comparison programs (30.7% vs. 12.2%), to be Spanish speakers (28.9% vs. 12.5%), and to be in the lowest household income bracket (66.9% vs. 54.2%). In both groups, about 64% of the children were male.

The intervention strategy aimed to reduce the reliance on screening tests. Instead, the study authors write, “our protocol emphasizes ASD screening as a process that includes clinician and parent decision-making.”

As Dr. Sheldrick explained, parents and specialists observe children together “and then decide whether it’s worth taking the next step, which is a full diagnostic assessment with a licensed professional.” According to the study, either the parent(s) or the specialists could make the referral for a full, university-based assessment.

The goal was to help specialists use their professional judgment more, he said, and refer children who don’t show signs of ASD via a screening instrument but still spark concern, he said. “We’re really trying to create a system in which the screening tools support professional judgment, but don’t really replace it.”

After weighting, the researchers found that diagnoses of ASD were more common in the intervention sites vs. comparison sites (incidence rate ratio, 1.6; 95% confidence interval, 1.3-2.1, P < .001), accounting for an extra 8.1 diagnoses per 1,000 per quarter. Among Spanish-speaking families only, diagnoses grew even more in the intervention sites vs. comparison sites (IRR, 2.6; 95% CI, 1.6-4.3; P < .001), representing 15.4 additional diagnoses per 1,000 children per quarter.

There was also an increase in diagnoses among boys in the intervention sites vs. comparison sites (IRR, 1.8; 95% CI, 1.4-2.3; P < .001), accounting for 14.8 additional diagnoses per 1,000 children per quarter. However, there was no statistically significant increase in diagnosis among girls (IRR, 1.1; 95% CI, 0.6-1.7; P = .84).

The finding about girls surprised the researchers. “The program was highly effective for boys, but really didn’t have any effect for girls,” Dr. Sheldrick said. “Even though autism is considered to be more common in boys, there are questions about whether it’s underidentified in girls. These data would be consistent with that view. So there’s work to do to be able to recognize how a young girl with autism might present and how you might note that in a sensitive way and then respond appropriately.”

The overall message of the study is “that screening with appropriate supports can make a difference,” he said. However, he acknowledged that the extra cost of the program is unclear. “We did not systematically collect data on cost,” he said, noting that the funding for the study paid for both the intervention and the analysis.

For now, he said, researchers are following the children in the study to see if they were able to access treatment services. Some of the investigators are also taking part in a randomized study to evaluate an intervention in children with social communication disorders, he said.

In an accompanying commentary, three pediatric specialists noted that the study is the first to analyze ASD screening in EI. “This study supports the notion of ASD screening as an iterative, multistep process that optimally involves multiple community stakeholders with varying levels of developmental expertise who have done the work to build trust with families,” write pediatrician Kate E. Wallis, MD, MPH, of Children’s Hospital of Philadelphia, graduate student Monica M. Abdul-Chani, MA, of the University of Alabama at Birmingham, and pediatrician Katharine E. Zuckerman, MD, MPH, of Oregon Health & Science University, Portland.

In regard to disparities in diagnosis in Spanish-speaking families, the commentary authors write that “locating a greater proportion of the ASD identification process in EI, which families are already familiar with, has no to low cost for families, and is likely geographically closer for families, can reduce structural barriers to identification.”

They add that the emphasis within Latino families on the “building of warm and caring relationships with others based on mutual trust and respect” can allow EI specialists to “develop relationships with families who may be afraid or skeptical of sharing what could be considered personal details of their family life.”

The commentary authors also note that “it remains all too common for language delays to be attributed to child exposure to two languages, even though data do not support this attribution. Bilingual EI staff can help to demystify this perpetual myth and better estimate a child’s communication and social skills in both languages as they communicate and play.”

The study was funded by grants from the Health Resources Services Administration and the National Institute of Mental Health. Dr. Sheldrick is cocreator of the Parent’s Observations of Social Interaction (POSI), which is one of the two first-stage screeners used in this study. He conducts research related to this instrument but receives no royalties. He reports grants from the National Institutes of Health. Coauthor Alice S. Carter, PhD, is cocreator of the POSI but receives no royalties. She is also cocreator of the Brief Infant Toddler Social Emotional Assessment, which is one of the two first-stage screeners used in this study, and receives royalties on the sale of the instrument. She reports grants from the National Institutes of Health and the Health Resources and Services Administration. Study coauthor Thomas I. Mackie, PhD, MPH, reports grants from the National Institute of Mental Health. Study coauthor Noah Hoch reports grants from the Health Resources Services Administration and the National Institute of Mental Health. No other disclosures from study authors are reported. Dr. Zuckerman reported grants from the National Institutes of Health and National Institute of Mental Health and consulting fees from H2N related to autism. The other commentary authors report no disclosures.

A new, augmented autism-screening strategy boosted the number of boys diagnosed with the condition, especially Spanish speakers, a new study finds. The research was published in JAMA Pediatrics

The number of diagnoses in girls didn’t budge significantly, however, surprising researchers. Still, the findings suggest that “multistage screening and appropriate access to diagnostic services can really move the needle on the early detection of autism and reducing disparities in autism diagnosis and detection,” said lead author R. Christopher Sheldrick, PhD, a Boston University research associate professor of health law, policy, and management, in an interview.

While early intervention is considered crucial, U.S. research suggests that several groups of children – the poor, racial and ethnic minorities, and non-English speakers – are more likely to be diagnosed with autism spectrum disorder (ASD) later in life. “They have much lower access to appropriate services, both to get kids diagnosed and to get the kinds of interventions that can be helpful for families,” Dr. Sheldrick said. “Our study is about trying to close the gap around diagnosis, the first step.”

For the new study, the researchers implemented an intervention strategy in Massachusetts at three Early Intervention (EI) programs, which provide autism screening to children who are referred by pediatricians or parents. The researchers then tracked the programs, all in Boston, and nine comparison programs from the greater Boston area from 2012 to 2018.

Overall, 33,326 children were assessed, all aged 14-36 months. Those at the intervention programs were chosen because they had high levels of poverty. Children at those programs were more likely to be Black than those at the comparison programs (30.7% vs. 12.2%), to be Spanish speakers (28.9% vs. 12.5%), and to be in the lowest household income bracket (66.9% vs. 54.2%). In both groups, about 64% of the children were male.

The intervention strategy aimed to reduce the reliance on screening tests. Instead, the study authors write, “our protocol emphasizes ASD screening as a process that includes clinician and parent decision-making.”

As Dr. Sheldrick explained, parents and specialists observe children together “and then decide whether it’s worth taking the next step, which is a full diagnostic assessment with a licensed professional.” According to the study, either the parent(s) or the specialists could make the referral for a full, university-based assessment.

The goal was to help specialists use their professional judgment more, he said, and refer children who don’t show signs of ASD via a screening instrument but still spark concern, he said. “We’re really trying to create a system in which the screening tools support professional judgment, but don’t really replace it.”

After weighting, the researchers found that diagnoses of ASD were more common in the intervention sites vs. comparison sites (incidence rate ratio, 1.6; 95% confidence interval, 1.3-2.1, P < .001), accounting for an extra 8.1 diagnoses per 1,000 per quarter. Among Spanish-speaking families only, diagnoses grew even more in the intervention sites vs. comparison sites (IRR, 2.6; 95% CI, 1.6-4.3; P < .001), representing 15.4 additional diagnoses per 1,000 children per quarter.

There was also an increase in diagnoses among boys in the intervention sites vs. comparison sites (IRR, 1.8; 95% CI, 1.4-2.3; P < .001), accounting for 14.8 additional diagnoses per 1,000 children per quarter. However, there was no statistically significant increase in diagnosis among girls (IRR, 1.1; 95% CI, 0.6-1.7; P = .84).

The finding about girls surprised the researchers. “The program was highly effective for boys, but really didn’t have any effect for girls,” Dr. Sheldrick said. “Even though autism is considered to be more common in boys, there are questions about whether it’s underidentified in girls. These data would be consistent with that view. So there’s work to do to be able to recognize how a young girl with autism might present and how you might note that in a sensitive way and then respond appropriately.”

The overall message of the study is “that screening with appropriate supports can make a difference,” he said. However, he acknowledged that the extra cost of the program is unclear. “We did not systematically collect data on cost,” he said, noting that the funding for the study paid for both the intervention and the analysis.

For now, he said, researchers are following the children in the study to see if they were able to access treatment services. Some of the investigators are also taking part in a randomized study to evaluate an intervention in children with social communication disorders, he said.

In an accompanying commentary, three pediatric specialists noted that the study is the first to analyze ASD screening in EI. “This study supports the notion of ASD screening as an iterative, multistep process that optimally involves multiple community stakeholders with varying levels of developmental expertise who have done the work to build trust with families,” write pediatrician Kate E. Wallis, MD, MPH, of Children’s Hospital of Philadelphia, graduate student Monica M. Abdul-Chani, MA, of the University of Alabama at Birmingham, and pediatrician Katharine E. Zuckerman, MD, MPH, of Oregon Health & Science University, Portland.

In regard to disparities in diagnosis in Spanish-speaking families, the commentary authors write that “locating a greater proportion of the ASD identification process in EI, which families are already familiar with, has no to low cost for families, and is likely geographically closer for families, can reduce structural barriers to identification.”

They add that the emphasis within Latino families on the “building of warm and caring relationships with others based on mutual trust and respect” can allow EI specialists to “develop relationships with families who may be afraid or skeptical of sharing what could be considered personal details of their family life.”

The commentary authors also note that “it remains all too common for language delays to be attributed to child exposure to two languages, even though data do not support this attribution. Bilingual EI staff can help to demystify this perpetual myth and better estimate a child’s communication and social skills in both languages as they communicate and play.”

The study was funded by grants from the Health Resources Services Administration and the National Institute of Mental Health. Dr. Sheldrick is cocreator of the Parent’s Observations of Social Interaction (POSI), which is one of the two first-stage screeners used in this study. He conducts research related to this instrument but receives no royalties. He reports grants from the National Institutes of Health. Coauthor Alice S. Carter, PhD, is cocreator of the POSI but receives no royalties. She is also cocreator of the Brief Infant Toddler Social Emotional Assessment, which is one of the two first-stage screeners used in this study, and receives royalties on the sale of the instrument. She reports grants from the National Institutes of Health and the Health Resources and Services Administration. Study coauthor Thomas I. Mackie, PhD, MPH, reports grants from the National Institute of Mental Health. Study coauthor Noah Hoch reports grants from the Health Resources Services Administration and the National Institute of Mental Health. No other disclosures from study authors are reported. Dr. Zuckerman reported grants from the National Institutes of Health and National Institute of Mental Health and consulting fees from H2N related to autism. The other commentary authors report no disclosures.

Registration now open: Gut Microbiota for Health World Summit 2022

Registration is now open for the Gut Microbiota for Health (GMFH) World Summit 2022, taking place March 12-13 in Washington, D.C., and virtually.  

Organized by AGA and the European Society of Neurogastroenterology and Motility (ESNM), the GMFH World Summit is the preeminent international meeting on the gut microbiome for clinicians, dietitians, and researchers. 

Now in its tenth year, this year’s program will focus on “The Gut Microbiome in Precision Nutrition and Medicine.” Join us to gain a deeper understanding of the role of the gut microbiome in precision medicine and discover personalized approaches to modulating the gut microbiome that may promote health and improve patient outcomes for a variety of disorders and diseases.

https://www.gutmicrobiotaforhealth.com/summit
 

See Gastroenterology’s curated Equity in GI journal collection

Gastroenterology is proud to announce the release of a special collection of articles focused on the intersection of diversity, equity, and inclusion (DEI) and gastroenterology and hepatology. This curated collection, under the guidance of the journal’s new DEI section editor Dr. Chyke Doubeni, includes original research, reviews, commentaries and editorials on matters of health disparities, socioeconomic determinants of health outcomes, and population-based studies on disease incidence among races and ethnicities, among other topics. New articles are added to the collection as they are published.

View the special collection on Gastroenterology’s website, which is designed to help you quickly and easily look over the latest DEI articles and content of interest. Recent articles include:

• How to incorporate health equity training into GI/hepatology fellowships by Jannel Lee-Allen and Brijen J. Shah
• Disparities in preventable mortality from colorectal cancer: are they the result of structural racism? By Chyke A. Doubeni, Kevin Selby and Theodore R. Levin
• COVID-19 pediatric patients: GI symptoms, presentations and disparities by race/ethnicity in a large, multicenter U.S. study by Yusuf Ashktorab, Anas Brim, Antonio Pizuorno, Vijay Gayam, Sahar Nikdel and Hassan Brim

View all of Gastroenterology’s curated article collections.

Registration now open: Gut Microbiota for Health World Summit 2022

Registration is now open for the Gut Microbiota for Health (GMFH) World Summit 2022, taking place March 12-13 in Washington, D.C., and virtually.  

Organized by AGA and the European Society of Neurogastroenterology and Motility (ESNM), the GMFH World Summit is the preeminent international meeting on the gut microbiome for clinicians, dietitians, and researchers. 

Now in its tenth year, this year’s program will focus on “The Gut Microbiome in Precision Nutrition and Medicine.” Join us to gain a deeper understanding of the role of the gut microbiome in precision medicine and discover personalized approaches to modulating the gut microbiome that may promote health and improve patient outcomes for a variety of disorders and diseases.

https://www.gutmicrobiotaforhealth.com/summit
 

See Gastroenterology’s curated Equity in GI journal collection

Gastroenterology is proud to announce the release of a special collection of articles focused on the intersection of diversity, equity, and inclusion (DEI) and gastroenterology and hepatology. This curated collection, under the guidance of the journal’s new DEI section editor Dr. Chyke Doubeni, includes original research, reviews, commentaries and editorials on matters of health disparities, socioeconomic determinants of health outcomes, and population-based studies on disease incidence among races and ethnicities, among other topics. New articles are added to the collection as they are published.

View the special collection on Gastroenterology’s website, which is designed to help you quickly and easily look over the latest DEI articles and content of interest. Recent articles include:

• How to incorporate health equity training into GI/hepatology fellowships by Jannel Lee-Allen and Brijen J. Shah
• Disparities in preventable mortality from colorectal cancer: are they the result of structural racism? By Chyke A. Doubeni, Kevin Selby and Theodore R. Levin
• COVID-19 pediatric patients: GI symptoms, presentations and disparities by race/ethnicity in a large, multicenter U.S. study by Yusuf Ashktorab, Anas Brim, Antonio Pizuorno, Vijay Gayam, Sahar Nikdel and Hassan Brim

View all of Gastroenterology’s curated article collections.

Registration now open: Gut Microbiota for Health World Summit 2022

Registration is now open for the Gut Microbiota for Health (GMFH) World Summit 2022, taking place March 12-13 in Washington, D.C., and virtually.  

Organized by AGA and the European Society of Neurogastroenterology and Motility (ESNM), the GMFH World Summit is the preeminent international meeting on the gut microbiome for clinicians, dietitians, and researchers. 

Now in its tenth year, this year’s program will focus on “The Gut Microbiome in Precision Nutrition and Medicine.” Join us to gain a deeper understanding of the role of the gut microbiome in precision medicine and discover personalized approaches to modulating the gut microbiome that may promote health and improve patient outcomes for a variety of disorders and diseases.

https://www.gutmicrobiotaforhealth.com/summit
 

See Gastroenterology’s curated Equity in GI journal collection

Gastroenterology is proud to announce the release of a special collection of articles focused on the intersection of diversity, equity, and inclusion (DEI) and gastroenterology and hepatology. This curated collection, under the guidance of the journal’s new DEI section editor Dr. Chyke Doubeni, includes original research, reviews, commentaries and editorials on matters of health disparities, socioeconomic determinants of health outcomes, and population-based studies on disease incidence among races and ethnicities, among other topics. New articles are added to the collection as they are published.

View the special collection on Gastroenterology’s website, which is designed to help you quickly and easily look over the latest DEI articles and content of interest. Recent articles include:

• How to incorporate health equity training into GI/hepatology fellowships by Jannel Lee-Allen and Brijen J. Shah
• Disparities in preventable mortality from colorectal cancer: are they the result of structural racism? By Chyke A. Doubeni, Kevin Selby and Theodore R. Levin
• COVID-19 pediatric patients: GI symptoms, presentations and disparities by race/ethnicity in a large, multicenter U.S. study by Yusuf Ashktorab, Anas Brim, Antonio Pizuorno, Vijay Gayam, Sahar Nikdel and Hassan Brim

View all of Gastroenterology’s curated article collections.

Getahun D, Fassett MJ, Jacobsen SJ, et al. Perinatal outcomes after bariatric surgery. Am J Obstet Gynecol. 2021;S0002-9378(21)00771-7. doi: 10.1016/j.ajog.2021 .06.087.

EXPERT COMMENTARY

Prepregnancy obesity continues to rise in the United States, with a prevalence of 29% among reproductive-age women in 2019, an 11% increase from 2016.¹ Pregnant patients with obesity are at increased risk for multiple adverse perinatal outcomes, including gestational diabetes and preeclampsia. Bariatric surgery is effective for weight loss and has been shown to improve comorbidities associated with obesity,² and it may have potential benefits for pregnancy outcomes, such as reducing rates of gestational diabetes and preeclampsia.^3-5 However, little was known about other outcomes as well as other potential factors before a recent study in which investigators examined perinatal outcomes after bariatric surgery.

Details of the study

Getahun and colleagues conducted a population-based, retrospective study of pregnant patients who were eligible for bariatric surgery (body mass index [BMI] ≥40 kg/m² with no comorbidities or a BMI between 35 and 40 kg/m² with obesity-related comorbidities, such as diabetes). They aimed to evaluate the association of bariatric surgery with adverse perinatal outcomes.

Results. In a large sample of pregnant patients eligible for bariatric surgery (N = 20,213), the authors found that patients who had bariatric surgery (n = 1,886) had a reduced risk of macrosomia (aOR, 0.24), preeclampsia (aOR, 0.53), gestational diabetes (aOR, 0.60), and cesarean delivery (aOR, 0.65) compared with those who did not have bariatric surgery (n = 18,327). They also found that patients who had bariatric surgery had an increased risk of small-for-gestational age neonates (aOR, 2.46) and postpartum hemorrhage (aOR, 1.79).

These results remained after adjusting for other potential confounders. The authors evaluated the outcomes based on the timing of surgery and the patients’ pregnancy (<1 year, 1-1.5 years, 1.5-2 years, >2 years). The outcomes were more favorable among the patients who had the bariatric surgery regardless of the time interval of surgery to pregnancy than those who did not have the surgery. In addition, the benefits of bariatric surgery did not differ between the 2 most common types of bariatric surgery (Roux-en-Y gastric bypass and vertical sleeve gastrectomy) performed in this study, and both had better outcomes than those who did not have the surgery. Finally, patients with chronic hypertension and pregestational diabetes who had bariatric surgery also had lower risks of adverse outcomes than those without bariatric surgery.

Study strengths and limitations

Given the study’s retrospective design, uncertainties and important confounders could not be addressed, such as why certain eligible patients had the surgery and others did not. However, with its large sample size and an appropriate comparison group, the study findings further support the perinatal benefits of bariatric surgery in obese patients. Of note, this study also had a large sample of Black and Hispanic patients, populations known to have higher rates of obesity¹ and pregnancy complications. Subgroup analyses within each racial/ethnic group revealed that those who had the surgery had lower risks of adverse perinatal outcomes than those who did not.

Patients who had the bariatric surgery had an increased risk of postpartum hemorrhage; however, there is no physiologic basis or theory to explain this finding, so further studies are needed. Lastly, although patients who had bariatric surgery had an increased risk of small-for-gestational-age babies and the study was not powered for the risk of stillbirth, the patients who had the surgery had a reduced risk of neonates admitted to the neonatal intensive care unit. More data would have been beneficial to assess if these small-for-gestational-age babies were healthy. In general, obese patients tend to have larger and unhealthy babies; thus, healthier babies, even if small for gestational age, would not be an adverse outcome.

Benefits of bariatric surgery extend to perinatal outcomes

This study reinforces current practice that includes eligible patients being counseled about the health-related benefits of bariatric surgery, which now includes more perinatal outcomes. The finding of the increased risk of small-for-gestational-age fetuses supports the practice of a screening growth ultrasound exam in patients who had bariatric surgery. ●

Getahun D, Fassett MJ, Jacobsen SJ, et al. Perinatal outcomes after bariatric surgery. Am J Obstet Gynecol. 2021;S0002-9378(21)00771-7. doi: 10.1016/j.ajog.2021 .06.087.

EXPERT COMMENTARY

Prepregnancy obesity continues to rise in the United States, with a prevalence of 29% among reproductive-age women in 2019, an 11% increase from 2016.¹ Pregnant patients with obesity are at increased risk for multiple adverse perinatal outcomes, including gestational diabetes and preeclampsia. Bariatric surgery is effective for weight loss and has been shown to improve comorbidities associated with obesity,² and it may have potential benefits for pregnancy outcomes, such as reducing rates of gestational diabetes and preeclampsia.^3-5 However, little was known about other outcomes as well as other potential factors before a recent study in which investigators examined perinatal outcomes after bariatric surgery.

Details of the study

Getahun and colleagues conducted a population-based, retrospective study of pregnant patients who were eligible for bariatric surgery (body mass index [BMI] ≥40 kg/m² with no comorbidities or a BMI between 35 and 40 kg/m² with obesity-related comorbidities, such as diabetes). They aimed to evaluate the association of bariatric surgery with adverse perinatal outcomes.

Results. In a large sample of pregnant patients eligible for bariatric surgery (N = 20,213), the authors found that patients who had bariatric surgery (n = 1,886) had a reduced risk of macrosomia (aOR, 0.24), preeclampsia (aOR, 0.53), gestational diabetes (aOR, 0.60), and cesarean delivery (aOR, 0.65) compared with those who did not have bariatric surgery (n = 18,327). They also found that patients who had bariatric surgery had an increased risk of small-for-gestational age neonates (aOR, 2.46) and postpartum hemorrhage (aOR, 1.79).

These results remained after adjusting for other potential confounders. The authors evaluated the outcomes based on the timing of surgery and the patients’ pregnancy (<1 year, 1-1.5 years, 1.5-2 years, >2 years). The outcomes were more favorable among the patients who had the bariatric surgery regardless of the time interval of surgery to pregnancy than those who did not have the surgery. In addition, the benefits of bariatric surgery did not differ between the 2 most common types of bariatric surgery (Roux-en-Y gastric bypass and vertical sleeve gastrectomy) performed in this study, and both had better outcomes than those who did not have the surgery. Finally, patients with chronic hypertension and pregestational diabetes who had bariatric surgery also had lower risks of adverse outcomes than those without bariatric surgery.

Study strengths and limitations

Given the study’s retrospective design, uncertainties and important confounders could not be addressed, such as why certain eligible patients had the surgery and others did not. However, with its large sample size and an appropriate comparison group, the study findings further support the perinatal benefits of bariatric surgery in obese patients. Of note, this study also had a large sample of Black and Hispanic patients, populations known to have higher rates of obesity¹ and pregnancy complications. Subgroup analyses within each racial/ethnic group revealed that those who had the surgery had lower risks of adverse perinatal outcomes than those who did not.

Patients who had the bariatric surgery had an increased risk of postpartum hemorrhage; however, there is no physiologic basis or theory to explain this finding, so further studies are needed. Lastly, although patients who had bariatric surgery had an increased risk of small-for-gestational-age babies and the study was not powered for the risk of stillbirth, the patients who had the surgery had a reduced risk of neonates admitted to the neonatal intensive care unit. More data would have been beneficial to assess if these small-for-gestational-age babies were healthy. In general, obese patients tend to have larger and unhealthy babies; thus, healthier babies, even if small for gestational age, would not be an adverse outcome.

Benefits of bariatric surgery extend to perinatal outcomes

This study reinforces current practice that includes eligible patients being counseled about the health-related benefits of bariatric surgery, which now includes more perinatal outcomes. The finding of the increased risk of small-for-gestational-age fetuses supports the practice of a screening growth ultrasound exam in patients who had bariatric surgery. ●

Getahun D, Fassett MJ, Jacobsen SJ, et al. Perinatal outcomes after bariatric surgery. Am J Obstet Gynecol. 2021;S0002-9378(21)00771-7. doi: 10.1016/j.ajog.2021 .06.087.

EXPERT COMMENTARY

Prepregnancy obesity continues to rise in the United States, with a prevalence of 29% among reproductive-age women in 2019, an 11% increase from 2016.¹ Pregnant patients with obesity are at increased risk for multiple adverse perinatal outcomes, including gestational diabetes and preeclampsia. Bariatric surgery is effective for weight loss and has been shown to improve comorbidities associated with obesity,² and it may have potential benefits for pregnancy outcomes, such as reducing rates of gestational diabetes and preeclampsia.^3-5 However, little was known about other outcomes as well as other potential factors before a recent study in which investigators examined perinatal outcomes after bariatric surgery.

Details of the study

Getahun and colleagues conducted a population-based, retrospective study of pregnant patients who were eligible for bariatric surgery (body mass index [BMI] ≥40 kg/m² with no comorbidities or a BMI between 35 and 40 kg/m² with obesity-related comorbidities, such as diabetes). They aimed to evaluate the association of bariatric surgery with adverse perinatal outcomes.

Results. In a large sample of pregnant patients eligible for bariatric surgery (N = 20,213), the authors found that patients who had bariatric surgery (n = 1,886) had a reduced risk of macrosomia (aOR, 0.24), preeclampsia (aOR, 0.53), gestational diabetes (aOR, 0.60), and cesarean delivery (aOR, 0.65) compared with those who did not have bariatric surgery (n = 18,327). They also found that patients who had bariatric surgery had an increased risk of small-for-gestational age neonates (aOR, 2.46) and postpartum hemorrhage (aOR, 1.79).

These results remained after adjusting for other potential confounders. The authors evaluated the outcomes based on the timing of surgery and the patients’ pregnancy (<1 year, 1-1.5 years, 1.5-2 years, >2 years). The outcomes were more favorable among the patients who had the bariatric surgery regardless of the time interval of surgery to pregnancy than those who did not have the surgery. In addition, the benefits of bariatric surgery did not differ between the 2 most common types of bariatric surgery (Roux-en-Y gastric bypass and vertical sleeve gastrectomy) performed in this study, and both had better outcomes than those who did not have the surgery. Finally, patients with chronic hypertension and pregestational diabetes who had bariatric surgery also had lower risks of adverse outcomes than those without bariatric surgery.

Study strengths and limitations

Given the study’s retrospective design, uncertainties and important confounders could not be addressed, such as why certain eligible patients had the surgery and others did not. However, with its large sample size and an appropriate comparison group, the study findings further support the perinatal benefits of bariatric surgery in obese patients. Of note, this study also had a large sample of Black and Hispanic patients, populations known to have higher rates of obesity¹ and pregnancy complications. Subgroup analyses within each racial/ethnic group revealed that those who had the surgery had lower risks of adverse perinatal outcomes than those who did not.

Patients who had the bariatric surgery had an increased risk of postpartum hemorrhage; however, there is no physiologic basis or theory to explain this finding, so further studies are needed. Lastly, although patients who had bariatric surgery had an increased risk of small-for-gestational-age babies and the study was not powered for the risk of stillbirth, the patients who had the surgery had a reduced risk of neonates admitted to the neonatal intensive care unit. More data would have been beneficial to assess if these small-for-gestational-age babies were healthy. In general, obese patients tend to have larger and unhealthy babies; thus, healthier babies, even if small for gestational age, would not be an adverse outcome.

Benefits of bariatric surgery extend to perinatal outcomes

This study reinforces current practice that includes eligible patients being counseled about the health-related benefits of bariatric surgery, which now includes more perinatal outcomes. The finding of the increased risk of small-for-gestational-age fetuses supports the practice of a screening growth ultrasound exam in patients who had bariatric surgery. ●

Having specific health issues, including depressive symptoms and cardiovascular disease, as a middle-aged woman was associated with experiencing clinically important declines in health later in life, a new study finds.

The most predictive parameters of poorer health at age 65 were cardiovascular disease, clinically significant depressive symptoms, and current smoking. Osteoarthritis, lower education level, and higher body mass index (BMI) also were associated with poorer health status 10 years on, Daniel H. Solomon, MD, MPH and colleagues wrote in their observational study, which was published in JAMA Network Open.

Determining a patient’s score on a health-related quality of life measure based on these variables might be useful in clinical practice to recognize midlife patients at increased risk for later health deterioration, Dr. Solomon, of the division of rheumatology, inflammation, and immunity at Brigham and Women’s Hospital, Boston, said in a statement. This measure is called the Short Form 36 (SF-36), and the researchers specifically focused on the physical component summary score (PCS) of this measure. The SF-36 is similar to the Framingham 10-year coronary heart disease risk prediction score, according to Dr. Solomon, who is a professor of medicine at Harvard Medical School, also in Boston.

Based on their risk scores, women could preemptively target modifiable risk factors before they enter old age, the investigators wrote.

“Age 55-65 may be a critical decade. A person’s health and factors during this period may set them on a path for their later adult years,” Dr. Solomon said in a statement. “The good news is that a large proportion of women at midlife are very stable and will not go on to experience declines. But being able to identify women at higher risk could help lead to interventions targeted to them.”
 

Study details

The study included a cohort of 1,091 women drawn from the 3,302-participant Study of Women’s Health Across the Nation (SWAN), a racially and ethnically diverse group enrolled from six U.S. sites at or immediately before transition to menopause and followed for 10 years from age 55 to 65. The study sample, consisting of 24.6% Black, 24% Japanese or Chinese, and 51.9% White, had a median baseline age of 54.8 years and median BMI of 27 kg/m² at entry. The median baseline PCS score was 53.1 (interquartile range, 46.8-56.7).

Over 10 years, 206 (18.9%) of the women in the study experienced clinically important declines of at least 8 points in baseline characteristics at around age 55. The following were significantly associated with these declines:

• Having a higher BMI.
• Having osteoarthritis.
• Having a lower educational level.
• Being a current smoker.
• Having clinically significant depressive symptoms.
• Having cardiovascular disease.
• Having better (or higher) physical health and function score on the PCS.

The association between a higher PCS score and a greater decline might seem like an anomaly, Dr. Solomon said in an interview, but one interpretation of this finding is that women with higher or better scores at baseline have further to fall once other risk factors take effect.

With data analyzed from October 2020 to March 2021, the median 10-year change in PCS was –1.02 points, but 206 women experienced declines of 8 points or more.

Those with health declines were more likely to be Black and less likely to be Japanese. They were also more likely to have other comorbidities such as diabetes, hypertension, and osteoporosis, and to report less physical activity.
 

Scoring system should not replace individualized evaluation, outside expert said

Commenting on the findings, Margaret J. Nachtigall, MD, a clinical associate professor in the department of obstetrics and gynecology at New York University Langone Health, cautioned that a generalized scoring system should not replace individualized evaluation of women at midlife.

“I assess women around age 55 on a daily basis for health risk factors going forward. And while a number such as BMI can be helpful, I worry that reliance on a score could miss treating the individual,” Dr. Nachtigall said an interview. For instance, one woman might have a high BMI owing to greater muscle mass, which is heavy, while another may have a lower BMI but more fat-related weight, as well as exacerbating conditions such as hypertension that would elevate her risk. “You have to make the calculation for each person.”

Dr. Nachtigall, who was not involved in the SWAN analysis, noted, however, that a big-data scoring system might be a useful adjunct to individual patient evaluation in that “it would make physicians look at all these many risk factors to identify those prone to decline.”
 

Study includes racially diverse population

According to the authors, while other studies have identified similar and other risk factors such as poor sleep, most have not included such a racially diverse population and have focused on women already in their senior years when the window of opportunity may already have closed.

“As a clinician and epidemiologist, I often think about the window of opportunity at midlife, when people are vital, engaged, and resilient,” said Dr. Solomon in the statement. “If we can identify risk factors and determine who is at risk, we may be able to find interventions that can stave off health declines and help put people on a better health trajectory.”

Eric M. Ascher, DO, who practices family medicine at Lenox Hill Hospital in New York and was not involved in the SWAN research, agreed with Dr. Solomon.

“Doctors who treat chronic conditions often meet patients when they are already suffering from a medical problem,” he said in an interview. “It is key to decrease your risk factors before it is too late.”

Dr. Ascher added that many primary care providers already rely heavily on scoring systems when determining level of risk and type of intervention. “Any additional risk factor-scoring systems that are easy to implement and will prevent chronic diseases would be something providers would want to use with their patients.”

Detailed analyses of larger at-risk populations are needed to validate these risk factors and identify others, the authors said.

SWAN is supported by the National Institute on Aging, the National Institute of Nursing Research, and the National Institutes of Heath’s Office of Research on Women’s Health. Dr. Solomon reported financial ties to Amgen, AbbVie and Moderna, UpToDate, and Arthritis & Rheumatology; as well as serving on the board of directors for the Childhood Arthritis and Rheumatology Research Alliance and an advisory committee for the Food and Drug Administration outside of this work. Dr. Nachtigall and Dr. Ascher disclosed no conflicts of interest with regard to their comments.

Having specific health issues, including depressive symptoms and cardiovascular disease, as a middle-aged woman was associated with experiencing clinically important declines in health later in life, a new study finds.

The most predictive parameters of poorer health at age 65 were cardiovascular disease, clinically significant depressive symptoms, and current smoking. Osteoarthritis, lower education level, and higher body mass index (BMI) also were associated with poorer health status 10 years on, Daniel H. Solomon, MD, MPH and colleagues wrote in their observational study, which was published in JAMA Network Open.

Determining a patient’s score on a health-related quality of life measure based on these variables might be useful in clinical practice to recognize midlife patients at increased risk for later health deterioration, Dr. Solomon, of the division of rheumatology, inflammation, and immunity at Brigham and Women’s Hospital, Boston, said in a statement. This measure is called the Short Form 36 (SF-36), and the researchers specifically focused on the physical component summary score (PCS) of this measure. The SF-36 is similar to the Framingham 10-year coronary heart disease risk prediction score, according to Dr. Solomon, who is a professor of medicine at Harvard Medical School, also in Boston.

Based on their risk scores, women could preemptively target modifiable risk factors before they enter old age, the investigators wrote.

“Age 55-65 may be a critical decade. A person’s health and factors during this period may set them on a path for their later adult years,” Dr. Solomon said in a statement. “The good news is that a large proportion of women at midlife are very stable and will not go on to experience declines. But being able to identify women at higher risk could help lead to interventions targeted to them.”
 

Study details

The study included a cohort of 1,091 women drawn from the 3,302-participant Study of Women’s Health Across the Nation (SWAN), a racially and ethnically diverse group enrolled from six U.S. sites at or immediately before transition to menopause and followed for 10 years from age 55 to 65. The study sample, consisting of 24.6% Black, 24% Japanese or Chinese, and 51.9% White, had a median baseline age of 54.8 years and median BMI of 27 kg/m² at entry. The median baseline PCS score was 53.1 (interquartile range, 46.8-56.7).

Over 10 years, 206 (18.9%) of the women in the study experienced clinically important declines of at least 8 points in baseline characteristics at around age 55. The following were significantly associated with these declines:

• Having a higher BMI.
• Having osteoarthritis.
• Having a lower educational level.
• Being a current smoker.
• Having clinically significant depressive symptoms.
• Having cardiovascular disease.
• Having better (or higher) physical health and function score on the PCS.

The association between a higher PCS score and a greater decline might seem like an anomaly, Dr. Solomon said in an interview, but one interpretation of this finding is that women with higher or better scores at baseline have further to fall once other risk factors take effect.

With data analyzed from October 2020 to March 2021, the median 10-year change in PCS was –1.02 points, but 206 women experienced declines of 8 points or more.

Those with health declines were more likely to be Black and less likely to be Japanese. They were also more likely to have other comorbidities such as diabetes, hypertension, and osteoporosis, and to report less physical activity.
 

Scoring system should not replace individualized evaluation, outside expert said

Commenting on the findings, Margaret J. Nachtigall, MD, a clinical associate professor in the department of obstetrics and gynecology at New York University Langone Health, cautioned that a generalized scoring system should not replace individualized evaluation of women at midlife.

“I assess women around age 55 on a daily basis for health risk factors going forward. And while a number such as BMI can be helpful, I worry that reliance on a score could miss treating the individual,” Dr. Nachtigall said an interview. For instance, one woman might have a high BMI owing to greater muscle mass, which is heavy, while another may have a lower BMI but more fat-related weight, as well as exacerbating conditions such as hypertension that would elevate her risk. “You have to make the calculation for each person.”

Dr. Nachtigall, who was not involved in the SWAN analysis, noted, however, that a big-data scoring system might be a useful adjunct to individual patient evaluation in that “it would make physicians look at all these many risk factors to identify those prone to decline.”
 

Study includes racially diverse population

According to the authors, while other studies have identified similar and other risk factors such as poor sleep, most have not included such a racially diverse population and have focused on women already in their senior years when the window of opportunity may already have closed.

“As a clinician and epidemiologist, I often think about the window of opportunity at midlife, when people are vital, engaged, and resilient,” said Dr. Solomon in the statement. “If we can identify risk factors and determine who is at risk, we may be able to find interventions that can stave off health declines and help put people on a better health trajectory.”

Eric M. Ascher, DO, who practices family medicine at Lenox Hill Hospital in New York and was not involved in the SWAN research, agreed with Dr. Solomon.

“Doctors who treat chronic conditions often meet patients when they are already suffering from a medical problem,” he said in an interview. “It is key to decrease your risk factors before it is too late.”

Dr. Ascher added that many primary care providers already rely heavily on scoring systems when determining level of risk and type of intervention. “Any additional risk factor-scoring systems that are easy to implement and will prevent chronic diseases would be something providers would want to use with their patients.”

Detailed analyses of larger at-risk populations are needed to validate these risk factors and identify others, the authors said.

SWAN is supported by the National Institute on Aging, the National Institute of Nursing Research, and the National Institutes of Heath’s Office of Research on Women’s Health. Dr. Solomon reported financial ties to Amgen, AbbVie and Moderna, UpToDate, and Arthritis & Rheumatology; as well as serving on the board of directors for the Childhood Arthritis and Rheumatology Research Alliance and an advisory committee for the Food and Drug Administration outside of this work. Dr. Nachtigall and Dr. Ascher disclosed no conflicts of interest with regard to their comments.

Having specific health issues, including depressive symptoms and cardiovascular disease, as a middle-aged woman was associated with experiencing clinically important declines in health later in life, a new study finds.

The most predictive parameters of poorer health at age 65 were cardiovascular disease, clinically significant depressive symptoms, and current smoking. Osteoarthritis, lower education level, and higher body mass index (BMI) also were associated with poorer health status 10 years on, Daniel H. Solomon, MD, MPH and colleagues wrote in their observational study, which was published in JAMA Network Open.

Determining a patient’s score on a health-related quality of life measure based on these variables might be useful in clinical practice to recognize midlife patients at increased risk for later health deterioration, Dr. Solomon, of the division of rheumatology, inflammation, and immunity at Brigham and Women’s Hospital, Boston, said in a statement. This measure is called the Short Form 36 (SF-36), and the researchers specifically focused on the physical component summary score (PCS) of this measure. The SF-36 is similar to the Framingham 10-year coronary heart disease risk prediction score, according to Dr. Solomon, who is a professor of medicine at Harvard Medical School, also in Boston.

Based on their risk scores, women could preemptively target modifiable risk factors before they enter old age, the investigators wrote.

“Age 55-65 may be a critical decade. A person’s health and factors during this period may set them on a path for their later adult years,” Dr. Solomon said in a statement. “The good news is that a large proportion of women at midlife are very stable and will not go on to experience declines. But being able to identify women at higher risk could help lead to interventions targeted to them.”
 

Study details

The study included a cohort of 1,091 women drawn from the 3,302-participant Study of Women’s Health Across the Nation (SWAN), a racially and ethnically diverse group enrolled from six U.S. sites at or immediately before transition to menopause and followed for 10 years from age 55 to 65. The study sample, consisting of 24.6% Black, 24% Japanese or Chinese, and 51.9% White, had a median baseline age of 54.8 years and median BMI of 27 kg/m² at entry. The median baseline PCS score was 53.1 (interquartile range, 46.8-56.7).

Over 10 years, 206 (18.9%) of the women in the study experienced clinically important declines of at least 8 points in baseline characteristics at around age 55. The following were significantly associated with these declines:

• Having a higher BMI.
• Having osteoarthritis.
• Having a lower educational level.
• Being a current smoker.
• Having clinically significant depressive symptoms.
• Having cardiovascular disease.
• Having better (or higher) physical health and function score on the PCS.

The association between a higher PCS score and a greater decline might seem like an anomaly, Dr. Solomon said in an interview, but one interpretation of this finding is that women with higher or better scores at baseline have further to fall once other risk factors take effect.

With data analyzed from October 2020 to March 2021, the median 10-year change in PCS was –1.02 points, but 206 women experienced declines of 8 points or more.

Those with health declines were more likely to be Black and less likely to be Japanese. They were also more likely to have other comorbidities such as diabetes, hypertension, and osteoporosis, and to report less physical activity.
 

Scoring system should not replace individualized evaluation, outside expert said

Commenting on the findings, Margaret J. Nachtigall, MD, a clinical associate professor in the department of obstetrics and gynecology at New York University Langone Health, cautioned that a generalized scoring system should not replace individualized evaluation of women at midlife.

“I assess women around age 55 on a daily basis for health risk factors going forward. And while a number such as BMI can be helpful, I worry that reliance on a score could miss treating the individual,” Dr. Nachtigall said an interview. For instance, one woman might have a high BMI owing to greater muscle mass, which is heavy, while another may have a lower BMI but more fat-related weight, as well as exacerbating conditions such as hypertension that would elevate her risk. “You have to make the calculation for each person.”

Dr. Nachtigall, who was not involved in the SWAN analysis, noted, however, that a big-data scoring system might be a useful adjunct to individual patient evaluation in that “it would make physicians look at all these many risk factors to identify those prone to decline.”
 

Study includes racially diverse population

According to the authors, while other studies have identified similar and other risk factors such as poor sleep, most have not included such a racially diverse population and have focused on women already in their senior years when the window of opportunity may already have closed.

“As a clinician and epidemiologist, I often think about the window of opportunity at midlife, when people are vital, engaged, and resilient,” said Dr. Solomon in the statement. “If we can identify risk factors and determine who is at risk, we may be able to find interventions that can stave off health declines and help put people on a better health trajectory.”

Eric M. Ascher, DO, who practices family medicine at Lenox Hill Hospital in New York and was not involved in the SWAN research, agreed with Dr. Solomon.

“Doctors who treat chronic conditions often meet patients when they are already suffering from a medical problem,” he said in an interview. “It is key to decrease your risk factors before it is too late.”

Dr. Ascher added that many primary care providers already rely heavily on scoring systems when determining level of risk and type of intervention. “Any additional risk factor-scoring systems that are easy to implement and will prevent chronic diseases would be something providers would want to use with their patients.”

Detailed analyses of larger at-risk populations are needed to validate these risk factors and identify others, the authors said.

SWAN is supported by the National Institute on Aging, the National Institute of Nursing Research, and the National Institutes of Heath’s Office of Research on Women’s Health. Dr. Solomon reported financial ties to Amgen, AbbVie and Moderna, UpToDate, and Arthritis & Rheumatology; as well as serving on the board of directors for the Childhood Arthritis and Rheumatology Research Alliance and an advisory committee for the Food and Drug Administration outside of this work. Dr. Nachtigall and Dr. Ascher disclosed no conflicts of interest with regard to their comments.