Federal Practitioner

If the nation’s primary care system were a patient, it would be in critical condition, researchers have found.

In delivery of primary care, including access and coordination, the U.S. trails well behind 10 other wealthy countries, according to a new report from the Commonwealth Fund.

The document, released March 15, concludes that the shortcomings in the U.S. system – from a lack of a relationship with a primary care physician to unequal access to after-hours care – “disproportionately affect Black and Latinx communities and rural areas, exacerbating disparities that have widened during the COVID-19 pandemic.”

“This report really shows that the U.S. is falling behind. We know that a strong primary care system yields better health outcomes. We have a lot to learn from other high-income countries,” coauthor Munira Z. Gunja, MPH, a senior researcher for the Commonwealth Fund’s International Program in Health Policy and Practice Innovations, told this news organization. “At baseline, we really need to make sure that everyone has health insurance in this country so they can actually use primary care services, and we need to increase the supply of those services.”

The report draws from the Commonwealth Fund’s 2019 and 2020 International Health Policy Surveys and the 2020 International Profiles of Health Care Systems. Among the main points:

• U.S. adults are the least likely to have a regular physician or place of care or a long-standing relationship with a primary care provider: 43% of American adults have a long-term relationship with a primary care doctor, compared with highs of 71% in Germany and the Netherlands.
• Access to home visits or after-hours care – excluding emergency department visits – is lowest in the United States (45%). In the Netherlands, Norway, New Zealand, and Germany, the rate is 90% to 96%.
• Half of primary care providers in the United States report adequate coordination with specialists and hospitals – around the average for the 11 countries studied.

‘Dismal mess’

Experts reacted to the report with a mix of concern and frustration – but not surprise.

“The results in this report are not surprising, and we have known them all for a number of years now,” Timothy Hoff, PhD, a health policy expert at Northeastern University, Boston, said. “Primary care doctors remain the backbone of our primary care system. But there are too few of them in the United States, and there likely will remain too few of them in the future. This opens the door to other and more diverse forms of innovation that will be required to help complement the work they do.”

Dr. Hoff, author of Searching for the Family Doctor: Primary Care on the Brink, added that comparing the United States to smaller countries like Norway or the United Kingdom is “somewhat problematic.”

“Our system has to take care of several hundred million people, trapped in a fragmented and market-based delivery system focused on specialty care, each of whom may have a different insurance plan,” he said. “Doing some of the things very small countries with government-funded insurance and a history of strong primary care delivery do in taking care of far fewer citizens is not realistic.”

Jeffrey Borkan, MD, PhD, chair and professor in the department of family medicine at the Alpert Medical School of Brown University, Providence, R.I., said the most shocking finding in the report is that despite spending far more on health care than any other country, “we cannot manage to provide one of the least expensive and most efficacious services: a relationship with a primary care doctor.”

Arthur Caplan, PhD, director of the Division of Medical Ethics at New York University Langone Medical Center, called primary care in this country “a dismal mess. It has been for many years. This is especially so in mental health. Access in many counties is nonexistent, and many primary care physicians are opting into boutique care.”

R. Shawn Martin, CEO of the 133,000-member American Academy of Family Physicians, said, “None of this surprises me. I think these are trendlines; we have been following this for many, many years here at the Academy.”

Mr. Martin added that he was disappointed that the recent, large investments in sharing and digitizing information have not closed the gaps that hinder the efficient and widespread delivery of primary care.

The findings in the report weren’t all bad. More primary care providers in the United States (30%) screen their patients for social needs such as housing, food security, and transportation – the highest among all 11 nations studied.

Also, Commonwealth Fund said the proportion of patients who said they received information on meeting their social needs and screening for domestic violence or social isolation was low everywhere. However, the percentage in the United States, Canada, and Norway was the highest, at 9%. Sweden had the lowest rate for such screenings, at 1%.

The researchers noted that social determinants of health account for as much as 55% of health outcomes. “In some countries, like the United States, the higher rates of receiving such information may be a response to the higher rates of material hardship, along with a weaker safety net,” the report states.

Ms. Gunja and her colleagues suggested several options for changes in policies, including narrowing the wage gap between primary care providers and higher-paid specialists; subsidizing medical school tuition to give students incentives to enter primary care; investing in telehealth to make primary care more accessible; and rewarding and holding providers accountable for continuity of care.

“The U.S. had the largest wage gap and highest tuition fees among the countries we studied,” Ms. Gunja told this news organization..

Researchers noted that U.S. patients could benefit from the introduction of incentives such as those paid in New Zealand to primary health organizations, which receive additional funding per capita to promote health and coordinate care.

But Dr. Caplan was skeptical that those measures would do much to correct the problems.

“We have no will to fix this ongoing, scandalous situation,” he said. “Specialist care still pays inordinately large salaries. Nurses and physician extenders are underused. Academic prestige does little to reward primary care. Plus, patients are not pressing for better access. Sorry, but I see no solutions pending in the current climate. Obamacare barely survived.”

The authors have disclosed no relevant financial relationships.

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

If the nation’s primary care system were a patient, it would be in critical condition, researchers have found.

In delivery of primary care, including access and coordination, the U.S. trails well behind 10 other wealthy countries, according to a new report from the Commonwealth Fund.

The document, released March 15, concludes that the shortcomings in the U.S. system – from a lack of a relationship with a primary care physician to unequal access to after-hours care – “disproportionately affect Black and Latinx communities and rural areas, exacerbating disparities that have widened during the COVID-19 pandemic.”

“This report really shows that the U.S. is falling behind. We know that a strong primary care system yields better health outcomes. We have a lot to learn from other high-income countries,” coauthor Munira Z. Gunja, MPH, a senior researcher for the Commonwealth Fund’s International Program in Health Policy and Practice Innovations, told this news organization. “At baseline, we really need to make sure that everyone has health insurance in this country so they can actually use primary care services, and we need to increase the supply of those services.”

The report draws from the Commonwealth Fund’s 2019 and 2020 International Health Policy Surveys and the 2020 International Profiles of Health Care Systems. Among the main points:

• U.S. adults are the least likely to have a regular physician or place of care or a long-standing relationship with a primary care provider: 43% of American adults have a long-term relationship with a primary care doctor, compared with highs of 71% in Germany and the Netherlands.
• Access to home visits or after-hours care – excluding emergency department visits – is lowest in the United States (45%). In the Netherlands, Norway, New Zealand, and Germany, the rate is 90% to 96%.
• Half of primary care providers in the United States report adequate coordination with specialists and hospitals – around the average for the 11 countries studied.

‘Dismal mess’

Experts reacted to the report with a mix of concern and frustration – but not surprise.

“The results in this report are not surprising, and we have known them all for a number of years now,” Timothy Hoff, PhD, a health policy expert at Northeastern University, Boston, said. “Primary care doctors remain the backbone of our primary care system. But there are too few of them in the United States, and there likely will remain too few of them in the future. This opens the door to other and more diverse forms of innovation that will be required to help complement the work they do.”

Dr. Hoff, author of Searching for the Family Doctor: Primary Care on the Brink, added that comparing the United States to smaller countries like Norway or the United Kingdom is “somewhat problematic.”

“Our system has to take care of several hundred million people, trapped in a fragmented and market-based delivery system focused on specialty care, each of whom may have a different insurance plan,” he said. “Doing some of the things very small countries with government-funded insurance and a history of strong primary care delivery do in taking care of far fewer citizens is not realistic.”

Jeffrey Borkan, MD, PhD, chair and professor in the department of family medicine at the Alpert Medical School of Brown University, Providence, R.I., said the most shocking finding in the report is that despite spending far more on health care than any other country, “we cannot manage to provide one of the least expensive and most efficacious services: a relationship with a primary care doctor.”

Arthur Caplan, PhD, director of the Division of Medical Ethics at New York University Langone Medical Center, called primary care in this country “a dismal mess. It has been for many years. This is especially so in mental health. Access in many counties is nonexistent, and many primary care physicians are opting into boutique care.”

R. Shawn Martin, CEO of the 133,000-member American Academy of Family Physicians, said, “None of this surprises me. I think these are trendlines; we have been following this for many, many years here at the Academy.”

Mr. Martin added that he was disappointed that the recent, large investments in sharing and digitizing information have not closed the gaps that hinder the efficient and widespread delivery of primary care.

The findings in the report weren’t all bad. More primary care providers in the United States (30%) screen their patients for social needs such as housing, food security, and transportation – the highest among all 11 nations studied.

Also, Commonwealth Fund said the proportion of patients who said they received information on meeting their social needs and screening for domestic violence or social isolation was low everywhere. However, the percentage in the United States, Canada, and Norway was the highest, at 9%. Sweden had the lowest rate for such screenings, at 1%.

The researchers noted that social determinants of health account for as much as 55% of health outcomes. “In some countries, like the United States, the higher rates of receiving such information may be a response to the higher rates of material hardship, along with a weaker safety net,” the report states.

Ms. Gunja and her colleagues suggested several options for changes in policies, including narrowing the wage gap between primary care providers and higher-paid specialists; subsidizing medical school tuition to give students incentives to enter primary care; investing in telehealth to make primary care more accessible; and rewarding and holding providers accountable for continuity of care.

“The U.S. had the largest wage gap and highest tuition fees among the countries we studied,” Ms. Gunja told this news organization..

Researchers noted that U.S. patients could benefit from the introduction of incentives such as those paid in New Zealand to primary health organizations, which receive additional funding per capita to promote health and coordinate care.

But Dr. Caplan was skeptical that those measures would do much to correct the problems.

“We have no will to fix this ongoing, scandalous situation,” he said. “Specialist care still pays inordinately large salaries. Nurses and physician extenders are underused. Academic prestige does little to reward primary care. Plus, patients are not pressing for better access. Sorry, but I see no solutions pending in the current climate. Obamacare barely survived.”

The authors have disclosed no relevant financial relationships.

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

If the nation’s primary care system were a patient, it would be in critical condition, researchers have found.

In delivery of primary care, including access and coordination, the U.S. trails well behind 10 other wealthy countries, according to a new report from the Commonwealth Fund.

The document, released March 15, concludes that the shortcomings in the U.S. system – from a lack of a relationship with a primary care physician to unequal access to after-hours care – “disproportionately affect Black and Latinx communities and rural areas, exacerbating disparities that have widened during the COVID-19 pandemic.”

“This report really shows that the U.S. is falling behind. We know that a strong primary care system yields better health outcomes. We have a lot to learn from other high-income countries,” coauthor Munira Z. Gunja, MPH, a senior researcher for the Commonwealth Fund’s International Program in Health Policy and Practice Innovations, told this news organization. “At baseline, we really need to make sure that everyone has health insurance in this country so they can actually use primary care services, and we need to increase the supply of those services.”

The report draws from the Commonwealth Fund’s 2019 and 2020 International Health Policy Surveys and the 2020 International Profiles of Health Care Systems. Among the main points:

• U.S. adults are the least likely to have a regular physician or place of care or a long-standing relationship with a primary care provider: 43% of American adults have a long-term relationship with a primary care doctor, compared with highs of 71% in Germany and the Netherlands.
• Access to home visits or after-hours care – excluding emergency department visits – is lowest in the United States (45%). In the Netherlands, Norway, New Zealand, and Germany, the rate is 90% to 96%.
• Half of primary care providers in the United States report adequate coordination with specialists and hospitals – around the average for the 11 countries studied.

‘Dismal mess’

Experts reacted to the report with a mix of concern and frustration – but not surprise.

“The results in this report are not surprising, and we have known them all for a number of years now,” Timothy Hoff, PhD, a health policy expert at Northeastern University, Boston, said. “Primary care doctors remain the backbone of our primary care system. But there are too few of them in the United States, and there likely will remain too few of them in the future. This opens the door to other and more diverse forms of innovation that will be required to help complement the work they do.”

Dr. Hoff, author of Searching for the Family Doctor: Primary Care on the Brink, added that comparing the United States to smaller countries like Norway or the United Kingdom is “somewhat problematic.”

“Our system has to take care of several hundred million people, trapped in a fragmented and market-based delivery system focused on specialty care, each of whom may have a different insurance plan,” he said. “Doing some of the things very small countries with government-funded insurance and a history of strong primary care delivery do in taking care of far fewer citizens is not realistic.”

Jeffrey Borkan, MD, PhD, chair and professor in the department of family medicine at the Alpert Medical School of Brown University, Providence, R.I., said the most shocking finding in the report is that despite spending far more on health care than any other country, “we cannot manage to provide one of the least expensive and most efficacious services: a relationship with a primary care doctor.”

Arthur Caplan, PhD, director of the Division of Medical Ethics at New York University Langone Medical Center, called primary care in this country “a dismal mess. It has been for many years. This is especially so in mental health. Access in many counties is nonexistent, and many primary care physicians are opting into boutique care.”

R. Shawn Martin, CEO of the 133,000-member American Academy of Family Physicians, said, “None of this surprises me. I think these are trendlines; we have been following this for many, many years here at the Academy.”

Mr. Martin added that he was disappointed that the recent, large investments in sharing and digitizing information have not closed the gaps that hinder the efficient and widespread delivery of primary care.

The findings in the report weren’t all bad. More primary care providers in the United States (30%) screen their patients for social needs such as housing, food security, and transportation – the highest among all 11 nations studied.

Also, Commonwealth Fund said the proportion of patients who said they received information on meeting their social needs and screening for domestic violence or social isolation was low everywhere. However, the percentage in the United States, Canada, and Norway was the highest, at 9%. Sweden had the lowest rate for such screenings, at 1%.

The researchers noted that social determinants of health account for as much as 55% of health outcomes. “In some countries, like the United States, the higher rates of receiving such information may be a response to the higher rates of material hardship, along with a weaker safety net,” the report states.

Ms. Gunja and her colleagues suggested several options for changes in policies, including narrowing the wage gap between primary care providers and higher-paid specialists; subsidizing medical school tuition to give students incentives to enter primary care; investing in telehealth to make primary care more accessible; and rewarding and holding providers accountable for continuity of care.

“The U.S. had the largest wage gap and highest tuition fees among the countries we studied,” Ms. Gunja told this news organization..

Researchers noted that U.S. patients could benefit from the introduction of incentives such as those paid in New Zealand to primary health organizations, which receive additional funding per capita to promote health and coordinate care.

But Dr. Caplan was skeptical that those measures would do much to correct the problems.

“We have no will to fix this ongoing, scandalous situation,” he said. “Specialist care still pays inordinately large salaries. Nurses and physician extenders are underused. Academic prestige does little to reward primary care. Plus, patients are not pressing for better access. Sorry, but I see no solutions pending in the current climate. Obamacare barely survived.”

The authors have disclosed no relevant financial relationships.

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

Researchers running the EMPA-KIDNEY trial that’s been testing the safety and efficacy of the SGLT2 inhibitor empagliflozin (Jardiance) in about 6,600 patients with chronic kidney disease (CKD) announced on March 16 that they had stopped the trial early because of positive efficacy that met the study’s prespecified threshold for early termination.

EMPA-KIDNEY is the third major trial of an agent from the sodium-glucose cotransport 2 (SGLT2) inhibitor class tested in patients with CKD to be stopped early because of positive results that met a prespecified termination rule.

HYWARDS/Getty Images

EMPA-KIDNEY enrolled a wider range of patients

EMPA-KIDNEY expands the scope of types of patients with CKD now shown to benefit from treatment with an SGLT2 inhibitor. CREDENCE tested canagliflozin only in patients with type 2 diabetes and diabetic nephropathy, and in DAPA-CKD, two-thirds of enrolled patients had type 2 diabetes, and all had CKD. In EMPA-KIDNEY, 46% of the 6,609 enrolled patients had diabetes (including a very small number with type 1 diabetes).

Another departure from prior studies of an SGLT2 inhibitor for patients selected primarily for having CKD was that in EMPA-KIDNEY, 20% of patients did not have albuminuria, and for 34%, eGFR at entry was less than 30 mL/min/1.73 m², with all enrolled patients required to have an eGFR at entry of greater than or equal to 20 mL/min/1.73 m². Average eGFR in EMPA-KIDNEY was about 38 mL/min/1.73 m². To be included in the trial, patients were not required to have albuminuria, except those whose eGFR was greater than or equal to 45 mL/min/1.73 m².

In DAPA-CKD, the minimum eGFR at entry had to be greater than or equal to 25 mL/min/1.73 m², and roughly 14% of enrolled patients had an eGFR of less than 30 mL/min/1.73 m². The average eGFR in DAPA-CKD was about 43 mL/min/1.73 m². In addition, all patients had at least microalbuminuria, with a minimum urinary albumin-to-creatinine ratio of 200. In CREDENCE, the minimum eGFR for enrollment was 30 mL/min/1.73 m², and the average eGFR was about 56 mL/min/1.73 m². All patients in CREDENCE had to have macroalbuminuria, with a urinary albumin-to-creatinine ratio of more than 300.

According to the researchers who designed EMPA-KIDNEY, the trial enrollment criteria aimed to include adults with CKD “who are frequently seen in practice but were under-represented in previous SGLT2 inhibitor trials.”

Indications for empagliflozin are expanding

The success of empagliflozin in EMPA-KIDNEY follows its positive results in both the EMPEROR-Reduced and EMPEROR-Preserved trials, which collectively proved the efficacy of the agent for patients with heart failure regardless of their left ventricular ejection fraction and regardless of whether they also had diabetes.

These results led the U.S. Food and Drug Administration to recently expand the labeled indication for empagliflozin to all patients with heart failure. Empagliflozin also has labeled indications for glycemic control in patients with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

As of today, empagliflozin has no labeled indication for treating patients with CKD. Dapagliflozin received that indication in April 2021, and canagliflozin received an indication for treating patients with type 2 diabetes, diabetic nephropathy, and albuminuria in September 2019.

EMPA-KIDNEY is sponsored by Boehringer Ingelheim and Lilly, the two companies that jointly market empagliflozin (Jardiance).

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

Researchers running the EMPA-KIDNEY trial that’s been testing the safety and efficacy of the SGLT2 inhibitor empagliflozin (Jardiance) in about 6,600 patients with chronic kidney disease (CKD) announced on March 16 that they had stopped the trial early because of positive efficacy that met the study’s prespecified threshold for early termination.

EMPA-KIDNEY is the third major trial of an agent from the sodium-glucose cotransport 2 (SGLT2) inhibitor class tested in patients with CKD to be stopped early because of positive results that met a prespecified termination rule.

HYWARDS/Getty Images

EMPA-KIDNEY enrolled a wider range of patients

EMPA-KIDNEY expands the scope of types of patients with CKD now shown to benefit from treatment with an SGLT2 inhibitor. CREDENCE tested canagliflozin only in patients with type 2 diabetes and diabetic nephropathy, and in DAPA-CKD, two-thirds of enrolled patients had type 2 diabetes, and all had CKD. In EMPA-KIDNEY, 46% of the 6,609 enrolled patients had diabetes (including a very small number with type 1 diabetes).

Another departure from prior studies of an SGLT2 inhibitor for patients selected primarily for having CKD was that in EMPA-KIDNEY, 20% of patients did not have albuminuria, and for 34%, eGFR at entry was less than 30 mL/min/1.73 m², with all enrolled patients required to have an eGFR at entry of greater than or equal to 20 mL/min/1.73 m². Average eGFR in EMPA-KIDNEY was about 38 mL/min/1.73 m². To be included in the trial, patients were not required to have albuminuria, except those whose eGFR was greater than or equal to 45 mL/min/1.73 m².

In DAPA-CKD, the minimum eGFR at entry had to be greater than or equal to 25 mL/min/1.73 m², and roughly 14% of enrolled patients had an eGFR of less than 30 mL/min/1.73 m². The average eGFR in DAPA-CKD was about 43 mL/min/1.73 m². In addition, all patients had at least microalbuminuria, with a minimum urinary albumin-to-creatinine ratio of 200. In CREDENCE, the minimum eGFR for enrollment was 30 mL/min/1.73 m², and the average eGFR was about 56 mL/min/1.73 m². All patients in CREDENCE had to have macroalbuminuria, with a urinary albumin-to-creatinine ratio of more than 300.

According to the researchers who designed EMPA-KIDNEY, the trial enrollment criteria aimed to include adults with CKD “who are frequently seen in practice but were under-represented in previous SGLT2 inhibitor trials.”

Indications for empagliflozin are expanding

The success of empagliflozin in EMPA-KIDNEY follows its positive results in both the EMPEROR-Reduced and EMPEROR-Preserved trials, which collectively proved the efficacy of the agent for patients with heart failure regardless of their left ventricular ejection fraction and regardless of whether they also had diabetes.

These results led the U.S. Food and Drug Administration to recently expand the labeled indication for empagliflozin to all patients with heart failure. Empagliflozin also has labeled indications for glycemic control in patients with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

As of today, empagliflozin has no labeled indication for treating patients with CKD. Dapagliflozin received that indication in April 2021, and canagliflozin received an indication for treating patients with type 2 diabetes, diabetic nephropathy, and albuminuria in September 2019.

EMPA-KIDNEY is sponsored by Boehringer Ingelheim and Lilly, the two companies that jointly market empagliflozin (Jardiance).

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

Researchers running the EMPA-KIDNEY trial that’s been testing the safety and efficacy of the SGLT2 inhibitor empagliflozin (Jardiance) in about 6,600 patients with chronic kidney disease (CKD) announced on March 16 that they had stopped the trial early because of positive efficacy that met the study’s prespecified threshold for early termination.

EMPA-KIDNEY is the third major trial of an agent from the sodium-glucose cotransport 2 (SGLT2) inhibitor class tested in patients with CKD to be stopped early because of positive results that met a prespecified termination rule.

HYWARDS/Getty Images

EMPA-KIDNEY enrolled a wider range of patients

EMPA-KIDNEY expands the scope of types of patients with CKD now shown to benefit from treatment with an SGLT2 inhibitor. CREDENCE tested canagliflozin only in patients with type 2 diabetes and diabetic nephropathy, and in DAPA-CKD, two-thirds of enrolled patients had type 2 diabetes, and all had CKD. In EMPA-KIDNEY, 46% of the 6,609 enrolled patients had diabetes (including a very small number with type 1 diabetes).

Another departure from prior studies of an SGLT2 inhibitor for patients selected primarily for having CKD was that in EMPA-KIDNEY, 20% of patients did not have albuminuria, and for 34%, eGFR at entry was less than 30 mL/min/1.73 m², with all enrolled patients required to have an eGFR at entry of greater than or equal to 20 mL/min/1.73 m². Average eGFR in EMPA-KIDNEY was about 38 mL/min/1.73 m². To be included in the trial, patients were not required to have albuminuria, except those whose eGFR was greater than or equal to 45 mL/min/1.73 m².

In DAPA-CKD, the minimum eGFR at entry had to be greater than or equal to 25 mL/min/1.73 m², and roughly 14% of enrolled patients had an eGFR of less than 30 mL/min/1.73 m². The average eGFR in DAPA-CKD was about 43 mL/min/1.73 m². In addition, all patients had at least microalbuminuria, with a minimum urinary albumin-to-creatinine ratio of 200. In CREDENCE, the minimum eGFR for enrollment was 30 mL/min/1.73 m², and the average eGFR was about 56 mL/min/1.73 m². All patients in CREDENCE had to have macroalbuminuria, with a urinary albumin-to-creatinine ratio of more than 300.

According to the researchers who designed EMPA-KIDNEY, the trial enrollment criteria aimed to include adults with CKD “who are frequently seen in practice but were under-represented in previous SGLT2 inhibitor trials.”

Indications for empagliflozin are expanding

The success of empagliflozin in EMPA-KIDNEY follows its positive results in both the EMPEROR-Reduced and EMPEROR-Preserved trials, which collectively proved the efficacy of the agent for patients with heart failure regardless of their left ventricular ejection fraction and regardless of whether they also had diabetes.

These results led the U.S. Food and Drug Administration to recently expand the labeled indication for empagliflozin to all patients with heart failure. Empagliflozin also has labeled indications for glycemic control in patients with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

As of today, empagliflozin has no labeled indication for treating patients with CKD. Dapagliflozin received that indication in April 2021, and canagliflozin received an indication for treating patients with type 2 diabetes, diabetic nephropathy, and albuminuria in September 2019.

EMPA-KIDNEY is sponsored by Boehringer Ingelheim and Lilly, the two companies that jointly market empagliflozin (Jardiance).

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

A large global report shows a decline in mental health worldwide, with the poorest outcomes reported in young adults.

The Mental Health Million project of Sapien Labs issued its second report, published online March 15, encompassing 34 countries and over 220,000 Internet-enabled adults. It found a continued decline in mental health in all age groups and genders, with English-speaking countries having the lowest mental well-being.

The decline was significantly correlated with the stringency of COVID-19 lockdown measures in each country and was directionally correlated to the cases and deaths per million.

The youngest age group (18-24 years) reported the poorest mental well-being, with better mental health scores rising in every successively older age group.

“Some of our findings, especially regarding mental health in young adults, are alarming,” Tara Thiagarajan, PhD, Sapien Labs founder and chief scientist, told this news organization.

“Our data, which are continually updated in real time, are freely available for nonprofit, noncommercial use and research, and we hope that researchers will get involved in an interdisciplinary way that spans sociology, economics, psychiatry, and other fields,” she said.
 

Pioneering research

Dr. Thiagarajan and her team pioneered the Mental Health Million project, an ongoing research initiative utilizing a “free and anonymous assessment tool,” the Mental Health Quotient (MHQ), which “encompasses a comprehensive view of our emotional, social, and cognitive function and capability.”

The MHQ consists of 47 “elements of mental well-being,” with scores ranging from –100 to +200. (Negative scores indicate poorer mental well-being.) The MHQ categorizes respondents as “clinical, at-risk, enduring, managing, succeeding, and thriving” and computes scores on the basis of six broad dimensions of mental health: core cognition, complex cognition, mood and outlook, drive and motivation, social self, and mind-body connection.

As reported by this news organization, Sapien Lab’s first Mental Health State of the World report (n = 49,000 adults) was conducted in eight English-speaking countries in 2020. Participants were compared to a smaller sample of people from the same countries polled in 2019.

In this year’s report, “we expanded quite substantially,” Dr. Thiagarajan said. The project added Spanish, French, and Arabic and recruited participants from 34 countries on six continents (n = 223,087) via advertising on Google and Facebook.

Economic prosperity not protective

Across the eight English-speaking countries, there was a decline in mental well-being of 3% from 2020 to 2021, which was smaller than the 8% decline from 2019 to 2020. The percentage of people who were “distressed or struggling” increased from 26% to 30% in 2021.

“Now that a lot of pandemic issue seems to be easing up, I hope we’ll see mental well-being coming back up, but at least it’s a smaller decline than we saw between 2019 and 2020,” said Dr. Thiagarajan.

The decline across countries from 2019 to 2021 was significantly correlated with the stringency of governmental COVID-19-related measures (based on the Oxford COVID-19 Government Response Tracker, 2022; r = .54) and directionally correlated to the cases and deaths per million.

In total, 30% of respondents in English-speaking countries had mental well-being scores in the “distressed” or “struggling” range – higher than the Middle Eastern countries, North Africa, Latin America, and Europe (23%, 23%, 24%, and 18%, respectively).

Only 36% of participants in the English-speaking countries, the Middle East, and North Africa reported “thriving or succeeding,” vs. 45% and 46% in Latin America and Europe, respectively. Venezuela topped the list with an average MHQ of 91, while the United Kingdom and South Africa had the lowest scores, at 46 each.

Mental well-being was slightly higher in males than in females but was dramatically lower in nonbinary/third-gender respondents. In fact, those identifying as nonbinary/third gender had the lowest mental well-being of any group.

Across all countries and languages, higher education was associated with better mental well-being. Employment was also associated with superior mental well-being, compared with being unemployed – particularly in core English-speaking countries.

However, “country indicators of economic prosperity were negatively correlated with mental well-being, particularly for young adults and males, belying the commonly held belief that national economic prosperity translates into greater mental well-being,” said Dr. Thiagarajan.
 

‘Stark’ contrast

The most dramatic finding was the difference in mental well-being between younger and older adults, which was two- to threefold larger than differences in other dimensions (for example, age, gender, employment). Even the maximum difference between countries overall (15%) was still smaller than the generational gap within any region.

While only 7% (6%- 9%) of participants aged ≥65 years were “distressed and struggling” with their mental well-being to a “clinical” extent, 44% (38%-50%) of those aged 18-24 years reported mental well-being scores in the “distressed or struggling” range – representing a “growing gap between generations that, while present prior to the COVID-19 pandemic, has since been exacerbated,” the authors state.

With every successive decrement in age group, mental well-being “plummeted,” Dr. Thiagarajan said. She noted that research conducted prior to 2010 in several regions of the world showed that young adults typically had the highest well-being. “Our findings stand in stark contrast to these previous patterns.”

The relationship between lockdown stringency and poorer mental health could play a role. “The impact of social isolation may be most strongly felt in younger people,” she said.
 

Internet a culprit?

“Within almost every region, scores for cognition and drive and motivation were highest while mood and outlook and social self were the lowest,” the authors report.

The aggregate percentage of respondents who reported being “distressed or struggling” in the various MHQ dimensions is shown in the following table.

Sedentary time

Commenting for this news organization, Bernardo Ng, MD, a member of the American Psychiatric Association’s Council on International Psychiatry and Global Health and medical director of Sun Valley Research Center, Imperial, Calif., called the report “interesting, with an impressive sample size” and an “impressive geographic distribution.”

Courtesy Sun Valley Research Center

Dr. Ng, who was not involved in the report, said, “I did not think the impact of Internet use on mental health was as dramatic before looking at this report.

“On the other hand, I have personally been interested in the impact of sedentarism in mental health – not only emotionally but also biologically. Sedentarism, which is directly related to screen use time, produces inflammation that worsens brain function.”

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

A large global report shows a decline in mental health worldwide, with the poorest outcomes reported in young adults.

The Mental Health Million project of Sapien Labs issued its second report, published online March 15, encompassing 34 countries and over 220,000 Internet-enabled adults. It found a continued decline in mental health in all age groups and genders, with English-speaking countries having the lowest mental well-being.

The decline was significantly correlated with the stringency of COVID-19 lockdown measures in each country and was directionally correlated to the cases and deaths per million.

The youngest age group (18-24 years) reported the poorest mental well-being, with better mental health scores rising in every successively older age group.

“Some of our findings, especially regarding mental health in young adults, are alarming,” Tara Thiagarajan, PhD, Sapien Labs founder and chief scientist, told this news organization.

“Our data, which are continually updated in real time, are freely available for nonprofit, noncommercial use and research, and we hope that researchers will get involved in an interdisciplinary way that spans sociology, economics, psychiatry, and other fields,” she said.
 

Pioneering research

Dr. Thiagarajan and her team pioneered the Mental Health Million project, an ongoing research initiative utilizing a “free and anonymous assessment tool,” the Mental Health Quotient (MHQ), which “encompasses a comprehensive view of our emotional, social, and cognitive function and capability.”

The MHQ consists of 47 “elements of mental well-being,” with scores ranging from –100 to +200. (Negative scores indicate poorer mental well-being.) The MHQ categorizes respondents as “clinical, at-risk, enduring, managing, succeeding, and thriving” and computes scores on the basis of six broad dimensions of mental health: core cognition, complex cognition, mood and outlook, drive and motivation, social self, and mind-body connection.

As reported by this news organization, Sapien Lab’s first Mental Health State of the World report (n = 49,000 adults) was conducted in eight English-speaking countries in 2020. Participants were compared to a smaller sample of people from the same countries polled in 2019.

In this year’s report, “we expanded quite substantially,” Dr. Thiagarajan said. The project added Spanish, French, and Arabic and recruited participants from 34 countries on six continents (n = 223,087) via advertising on Google and Facebook.

Economic prosperity not protective

Across the eight English-speaking countries, there was a decline in mental well-being of 3% from 2020 to 2021, which was smaller than the 8% decline from 2019 to 2020. The percentage of people who were “distressed or struggling” increased from 26% to 30% in 2021.

“Now that a lot of pandemic issue seems to be easing up, I hope we’ll see mental well-being coming back up, but at least it’s a smaller decline than we saw between 2019 and 2020,” said Dr. Thiagarajan.

The decline across countries from 2019 to 2021 was significantly correlated with the stringency of governmental COVID-19-related measures (based on the Oxford COVID-19 Government Response Tracker, 2022; r = .54) and directionally correlated to the cases and deaths per million.

In total, 30% of respondents in English-speaking countries had mental well-being scores in the “distressed” or “struggling” range – higher than the Middle Eastern countries, North Africa, Latin America, and Europe (23%, 23%, 24%, and 18%, respectively).

Only 36% of participants in the English-speaking countries, the Middle East, and North Africa reported “thriving or succeeding,” vs. 45% and 46% in Latin America and Europe, respectively. Venezuela topped the list with an average MHQ of 91, while the United Kingdom and South Africa had the lowest scores, at 46 each.

Mental well-being was slightly higher in males than in females but was dramatically lower in nonbinary/third-gender respondents. In fact, those identifying as nonbinary/third gender had the lowest mental well-being of any group.

Across all countries and languages, higher education was associated with better mental well-being. Employment was also associated with superior mental well-being, compared with being unemployed – particularly in core English-speaking countries.

However, “country indicators of economic prosperity were negatively correlated with mental well-being, particularly for young adults and males, belying the commonly held belief that national economic prosperity translates into greater mental well-being,” said Dr. Thiagarajan.
 

‘Stark’ contrast

The most dramatic finding was the difference in mental well-being between younger and older adults, which was two- to threefold larger than differences in other dimensions (for example, age, gender, employment). Even the maximum difference between countries overall (15%) was still smaller than the generational gap within any region.

While only 7% (6%- 9%) of participants aged ≥65 years were “distressed and struggling” with their mental well-being to a “clinical” extent, 44% (38%-50%) of those aged 18-24 years reported mental well-being scores in the “distressed or struggling” range – representing a “growing gap between generations that, while present prior to the COVID-19 pandemic, has since been exacerbated,” the authors state.

With every successive decrement in age group, mental well-being “plummeted,” Dr. Thiagarajan said. She noted that research conducted prior to 2010 in several regions of the world showed that young adults typically had the highest well-being. “Our findings stand in stark contrast to these previous patterns.”

The relationship between lockdown stringency and poorer mental health could play a role. “The impact of social isolation may be most strongly felt in younger people,” she said.
 

Internet a culprit?

“Within almost every region, scores for cognition and drive and motivation were highest while mood and outlook and social self were the lowest,” the authors report.

The aggregate percentage of respondents who reported being “distressed or struggling” in the various MHQ dimensions is shown in the following table.

Sedentary time

Commenting for this news organization, Bernardo Ng, MD, a member of the American Psychiatric Association’s Council on International Psychiatry and Global Health and medical director of Sun Valley Research Center, Imperial, Calif., called the report “interesting, with an impressive sample size” and an “impressive geographic distribution.”

Courtesy Sun Valley Research Center

Dr. Ng, who was not involved in the report, said, “I did not think the impact of Internet use on mental health was as dramatic before looking at this report.

“On the other hand, I have personally been interested in the impact of sedentarism in mental health – not only emotionally but also biologically. Sedentarism, which is directly related to screen use time, produces inflammation that worsens brain function.”

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

A large global report shows a decline in mental health worldwide, with the poorest outcomes reported in young adults.

The Mental Health Million project of Sapien Labs issued its second report, published online March 15, encompassing 34 countries and over 220,000 Internet-enabled adults. It found a continued decline in mental health in all age groups and genders, with English-speaking countries having the lowest mental well-being.

The decline was significantly correlated with the stringency of COVID-19 lockdown measures in each country and was directionally correlated to the cases and deaths per million.

The youngest age group (18-24 years) reported the poorest mental well-being, with better mental health scores rising in every successively older age group.

“Some of our findings, especially regarding mental health in young adults, are alarming,” Tara Thiagarajan, PhD, Sapien Labs founder and chief scientist, told this news organization.

“Our data, which are continually updated in real time, are freely available for nonprofit, noncommercial use and research, and we hope that researchers will get involved in an interdisciplinary way that spans sociology, economics, psychiatry, and other fields,” she said.
 

Pioneering research

Dr. Thiagarajan and her team pioneered the Mental Health Million project, an ongoing research initiative utilizing a “free and anonymous assessment tool,” the Mental Health Quotient (MHQ), which “encompasses a comprehensive view of our emotional, social, and cognitive function and capability.”

The MHQ consists of 47 “elements of mental well-being,” with scores ranging from –100 to +200. (Negative scores indicate poorer mental well-being.) The MHQ categorizes respondents as “clinical, at-risk, enduring, managing, succeeding, and thriving” and computes scores on the basis of six broad dimensions of mental health: core cognition, complex cognition, mood and outlook, drive and motivation, social self, and mind-body connection.

As reported by this news organization, Sapien Lab’s first Mental Health State of the World report (n = 49,000 adults) was conducted in eight English-speaking countries in 2020. Participants were compared to a smaller sample of people from the same countries polled in 2019.

In this year’s report, “we expanded quite substantially,” Dr. Thiagarajan said. The project added Spanish, French, and Arabic and recruited participants from 34 countries on six continents (n = 223,087) via advertising on Google and Facebook.

Economic prosperity not protective

Across the eight English-speaking countries, there was a decline in mental well-being of 3% from 2020 to 2021, which was smaller than the 8% decline from 2019 to 2020. The percentage of people who were “distressed or struggling” increased from 26% to 30% in 2021.

“Now that a lot of pandemic issue seems to be easing up, I hope we’ll see mental well-being coming back up, but at least it’s a smaller decline than we saw between 2019 and 2020,” said Dr. Thiagarajan.

The decline across countries from 2019 to 2021 was significantly correlated with the stringency of governmental COVID-19-related measures (based on the Oxford COVID-19 Government Response Tracker, 2022; r = .54) and directionally correlated to the cases and deaths per million.

In total, 30% of respondents in English-speaking countries had mental well-being scores in the “distressed” or “struggling” range – higher than the Middle Eastern countries, North Africa, Latin America, and Europe (23%, 23%, 24%, and 18%, respectively).

Only 36% of participants in the English-speaking countries, the Middle East, and North Africa reported “thriving or succeeding,” vs. 45% and 46% in Latin America and Europe, respectively. Venezuela topped the list with an average MHQ of 91, while the United Kingdom and South Africa had the lowest scores, at 46 each.

Mental well-being was slightly higher in males than in females but was dramatically lower in nonbinary/third-gender respondents. In fact, those identifying as nonbinary/third gender had the lowest mental well-being of any group.

Across all countries and languages, higher education was associated with better mental well-being. Employment was also associated with superior mental well-being, compared with being unemployed – particularly in core English-speaking countries.

However, “country indicators of economic prosperity were negatively correlated with mental well-being, particularly for young adults and males, belying the commonly held belief that national economic prosperity translates into greater mental well-being,” said Dr. Thiagarajan.
 

‘Stark’ contrast

The most dramatic finding was the difference in mental well-being between younger and older adults, which was two- to threefold larger than differences in other dimensions (for example, age, gender, employment). Even the maximum difference between countries overall (15%) was still smaller than the generational gap within any region.

While only 7% (6%- 9%) of participants aged ≥65 years were “distressed and struggling” with their mental well-being to a “clinical” extent, 44% (38%-50%) of those aged 18-24 years reported mental well-being scores in the “distressed or struggling” range – representing a “growing gap between generations that, while present prior to the COVID-19 pandemic, has since been exacerbated,” the authors state.

With every successive decrement in age group, mental well-being “plummeted,” Dr. Thiagarajan said. She noted that research conducted prior to 2010 in several regions of the world showed that young adults typically had the highest well-being. “Our findings stand in stark contrast to these previous patterns.”

The relationship between lockdown stringency and poorer mental health could play a role. “The impact of social isolation may be most strongly felt in younger people,” she said.
 

Internet a culprit?

“Within almost every region, scores for cognition and drive and motivation were highest while mood and outlook and social self were the lowest,” the authors report.

The aggregate percentage of respondents who reported being “distressed or struggling” in the various MHQ dimensions is shown in the following table.

Sedentary time

Commenting for this news organization, Bernardo Ng, MD, a member of the American Psychiatric Association’s Council on International Psychiatry and Global Health and medical director of Sun Valley Research Center, Imperial, Calif., called the report “interesting, with an impressive sample size” and an “impressive geographic distribution.”

Courtesy Sun Valley Research Center

Dr. Ng, who was not involved in the report, said, “I did not think the impact of Internet use on mental health was as dramatic before looking at this report.

“On the other hand, I have personally been interested in the impact of sedentarism in mental health – not only emotionally but also biologically. Sedentarism, which is directly related to screen use time, produces inflammation that worsens brain function.”

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

WASHINGTON – Research on standardized microbiome-based therapies designed to prevent the recurrence of Clostridioides difficile infection (CDI) is moving “with a lot of momentum,” according to one expert, and modulation of the gut microbiome may even enhance responses to immunotherapy and/or abrogate toxicity, according to another.

Several products for prevention of CDI recurrence are poised for either phase 3 trials or upcoming Food and Drug Administration approval, Sahil Khanna, MBBS, MS, professor of medicine, gastroenterology, and hepatology at the Mayo Clinic in Rochester, Minn., reported at the annual Gut Microbiota for Health World Summit.

Jennifer A. Wargo, MD, MMSc, of the University of Texas MD Anderson Cancer Center, Houston, described her investigations of microbiome modulation’s role in cancer treatment. “I used to say yes [we can do this] somewhat enthusiastically without data, but now we have data to support this,” she said at the meeting, sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility. “The answer now is totally yes.”
 

New approaches for CDI

“Based on how the field is moving, we might be able to [offer our patients] earlier microbiome restoration” than is currently afforded with fecal microbiota transplantation (FMT), he said. “Right now the [Food and Drug Administration] and our clinical guidelines say we should do FMT after three or more episodes [of CDI] – that’s heartbreaking for patients.”

Several of the microbiome-based therapies under investigation – including two poised for phase 3 trials – have shown efficacy after a second episode of CDI, and one of these two has also had positive results after one episode of CDI in patients 65 at older, a group at particularly high risk of recurrence, said Dr. Khanna.

The value of standardized, mostly pill-form microbiome therapies has been heightened during the pandemic. “We’ve been doing conventional FMT for recurrent C. difficile for over a decade now, and it’s probably the most effective treatment we have,” said Colleen R. Kelly, MD, associate professor of medicine at Brown University, Providence, R.I., and moderator of the session on microbiota-based therapies.

Prepandemic “it got really hard, with issues of identifying donors, and quality control and safety ... And then when COVID hit the stool banks shut down,” she said in an interview after the meeting. With stool testing for SARS-CoV-2 now in place, some stool is again available, “but it made me realize how fragile our current system is,” Dr. Kelly said. “The fact that companies are putting these products through the FDA pipeline and investigating them in rigorous, scientific randomized controlled trials is really good for the field.”

The products vary in composition; some are live multi-strain biotherapeutics derived from donor stool, for instance, while others are defined live bacterial consortia not from stool. Most are oral formulations, given one or multiple times, that do not require any bowel preparation.

One of the products most advanced in the pipeline, RBX2660 (Rebiotix, Ferring Pharmaceuticals) is stool derived and rectally administered. In phase 3 research, 70.5% of patients who received one active enema after having had two or more CDI recurrences and standard-of-care antibiotic treatment had no additional recurrence at 8 weeks compared to 58.1% in the placebo group, Dr. Khanna said.

The other product with positive phase 3 results, SER-109 (Seres Therapeutics), is a donor stool-derived oral formulation of purified Firmicutes spores that is administered after bowel prep. In results published earlier this year, the percentage of patients with recurrence of CDI up to 8 weeks after standard antibiotic treatment was 12% in the SER-109 group and 40% in the placebo group.

Patients in this trial were required to have had three episodes of CDI, and interestingly, Dr. Khanna said, the diagnosis of CDI was made only by toxin enzyme immunoassay (EIA). Earlier phase 2 research, which allowed either toxin EIA or polymerase chain reaction testing for the diagnosis of CDI (as other trials have done), produced negative results, leading investigators to surmise that some of the included patients had been colonized with C. difficile rather than being actively infected, Dr. Khanna said.

Researchers of these trials are documenting not only resolution of CDI but what they believe are positive shifts in the gut microbiota after microbiome-based therapy, he said. For instance, a phase 1 trial he led of the product RBX7455 (Rebiotix, Ferring Pharmaceuticals) – an oral capsule of lyophilized stool-based bacteria that can be kept for several days at room temperature – showed increases in Bacteroidia and Clostridia.

And other trials’ analyses of microbiome engraftment have demonstrated that “you can restore [species] even when these bacteria aren’t [included in the therapy],” he noted. “As the milieu of the gut improves, species that were not detected start coming back up.”

Asked about rates of efficacy in the trials’ placebo arms, Dr. Khanna said that “we’ve become smarter with our antibiotic regimens ... the placebo response rate is the response to newer guideline-based therapies.”

In addition to CDI, microbiome-based therapies are being studied, mostly in phase 1 research, for indications such as Crohn’s disease, ulcerative colitis, autism spectrum disorder, hepatitis B, and hepatic encephalopathy, Dr. Khanna noted.

Dr. Kelly, whose own research has focused on FMT for CDI, said she anticipates an expansion of research into other indications once products to prevent CDI recurrence are on the market. “There have been a couple of promising ulcerative colitis trials that haven’t gone anywhere clinically yet,” she said in the interview. “But will we now identify patients with UC who may be more sensitive to microbial manipulation, for whom we can use these microbial therapies along with a biologic?”

Some of her patients with IBD and CDI who are treated with FMT have not only had their CDI eradicated but have subsequently seen improvements in their IBD, she noted.

The role of traditional FMT and of stool banks will likely change in the future with new standardized oral microbiome-based therapies that can be approved and regulated by the FDA, she said. However, “we think the stool banks will still have some value,” she said, certainly for clinical research and probably for some treatment purposes as well. Regarding new therapies, “I just really hope they’re affordable,” she said.
 

Gut microbiome manipulation for cancer

Dr. Wargo’s research at MD Anderson has focused on metastatic breast cancer and immunotherapeutic checkpoint blockade. By sequencing microbiota samples and performing immune profiling in hundreds of patients, her team found that responders to PD-1 blockage have a greater diversity of gut bacteria and that “favorable signatures in the gut microbiome” are associated with enhanced immune responses in the tumor microenvironment.

Studies published last year in Science from investigators in Israel (2021 Feb 5;371[6529]:602-9) and Pittsburgh (2021 Feb 5;371[6529]:595-602), demonstrated that FMT promotes response in immunotherapy-refractory melanoma patients. In one study, FMT provided clinical benefit in 6 of 15 patients whose cancer had progressed on prior anti-PD-1 therapy, “which is pretty remarkable,” Dr. Wargo said.

Both research groups, she noted, saw favorable changes in the gut microbiome and immune cell infiltrates both at the level of the colon and the tumor.

Current research on FMT and other microbiome modulation strategies for cancer is guided in part by knowledge that tumors have microbial signatures – these signatures are now being identified across all tumor types – and by findings of “cross talk” between the gut and tumor microbiomes, she explained.

“Researchers are working hard to identify optimal consortia to enhance immune responses in the cancer setting, with promising work in preclinical models,” she said, and clinical trials are in progress. The role of diet in modulating the microbiome and enhancing anti-tumor immunity, with a focus on high dietary fiber intake, is also being investigated, she said.

Dr. Wargo reported that she serves on the advisory boards and is a paid speaker of numerous pharmaceutical and biotechnology companies, and is the coinventor of a patent submitted by the Texas MD Anderson Cancer Center on modulating the microbiome to enhance response to checkpoint blockade, and another related patent. Dr. Khanna reported that he is involved in research with Ferring/Rebiotix, Finch, Seres, Pfizer and Vendata, and does consulting for Immuron and several other companies. Dr. Kelly said she serves as an unpaid adviser for OpenBiome, a nonprofit stool bank, and that her site has enrolled patients in two of the trials testing products for CDI.

WASHINGTON – Research on standardized microbiome-based therapies designed to prevent the recurrence of Clostridioides difficile infection (CDI) is moving “with a lot of momentum,” according to one expert, and modulation of the gut microbiome may even enhance responses to immunotherapy and/or abrogate toxicity, according to another.

Several products for prevention of CDI recurrence are poised for either phase 3 trials or upcoming Food and Drug Administration approval, Sahil Khanna, MBBS, MS, professor of medicine, gastroenterology, and hepatology at the Mayo Clinic in Rochester, Minn., reported at the annual Gut Microbiota for Health World Summit.

Jennifer A. Wargo, MD, MMSc, of the University of Texas MD Anderson Cancer Center, Houston, described her investigations of microbiome modulation’s role in cancer treatment. “I used to say yes [we can do this] somewhat enthusiastically without data, but now we have data to support this,” she said at the meeting, sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility. “The answer now is totally yes.”
 

New approaches for CDI

“Based on how the field is moving, we might be able to [offer our patients] earlier microbiome restoration” than is currently afforded with fecal microbiota transplantation (FMT), he said. “Right now the [Food and Drug Administration] and our clinical guidelines say we should do FMT after three or more episodes [of CDI] – that’s heartbreaking for patients.”

Several of the microbiome-based therapies under investigation – including two poised for phase 3 trials – have shown efficacy after a second episode of CDI, and one of these two has also had positive results after one episode of CDI in patients 65 at older, a group at particularly high risk of recurrence, said Dr. Khanna.

The value of standardized, mostly pill-form microbiome therapies has been heightened during the pandemic. “We’ve been doing conventional FMT for recurrent C. difficile for over a decade now, and it’s probably the most effective treatment we have,” said Colleen R. Kelly, MD, associate professor of medicine at Brown University, Providence, R.I., and moderator of the session on microbiota-based therapies.

Prepandemic “it got really hard, with issues of identifying donors, and quality control and safety ... And then when COVID hit the stool banks shut down,” she said in an interview after the meeting. With stool testing for SARS-CoV-2 now in place, some stool is again available, “but it made me realize how fragile our current system is,” Dr. Kelly said. “The fact that companies are putting these products through the FDA pipeline and investigating them in rigorous, scientific randomized controlled trials is really good for the field.”

The products vary in composition; some are live multi-strain biotherapeutics derived from donor stool, for instance, while others are defined live bacterial consortia not from stool. Most are oral formulations, given one or multiple times, that do not require any bowel preparation.

One of the products most advanced in the pipeline, RBX2660 (Rebiotix, Ferring Pharmaceuticals) is stool derived and rectally administered. In phase 3 research, 70.5% of patients who received one active enema after having had two or more CDI recurrences and standard-of-care antibiotic treatment had no additional recurrence at 8 weeks compared to 58.1% in the placebo group, Dr. Khanna said.

The other product with positive phase 3 results, SER-109 (Seres Therapeutics), is a donor stool-derived oral formulation of purified Firmicutes spores that is administered after bowel prep. In results published earlier this year, the percentage of patients with recurrence of CDI up to 8 weeks after standard antibiotic treatment was 12% in the SER-109 group and 40% in the placebo group.

Patients in this trial were required to have had three episodes of CDI, and interestingly, Dr. Khanna said, the diagnosis of CDI was made only by toxin enzyme immunoassay (EIA). Earlier phase 2 research, which allowed either toxin EIA or polymerase chain reaction testing for the diagnosis of CDI (as other trials have done), produced negative results, leading investigators to surmise that some of the included patients had been colonized with C. difficile rather than being actively infected, Dr. Khanna said.

Researchers of these trials are documenting not only resolution of CDI but what they believe are positive shifts in the gut microbiota after microbiome-based therapy, he said. For instance, a phase 1 trial he led of the product RBX7455 (Rebiotix, Ferring Pharmaceuticals) – an oral capsule of lyophilized stool-based bacteria that can be kept for several days at room temperature – showed increases in Bacteroidia and Clostridia.

And other trials’ analyses of microbiome engraftment have demonstrated that “you can restore [species] even when these bacteria aren’t [included in the therapy],” he noted. “As the milieu of the gut improves, species that were not detected start coming back up.”

Asked about rates of efficacy in the trials’ placebo arms, Dr. Khanna said that “we’ve become smarter with our antibiotic regimens ... the placebo response rate is the response to newer guideline-based therapies.”

In addition to CDI, microbiome-based therapies are being studied, mostly in phase 1 research, for indications such as Crohn’s disease, ulcerative colitis, autism spectrum disorder, hepatitis B, and hepatic encephalopathy, Dr. Khanna noted.

Dr. Kelly, whose own research has focused on FMT for CDI, said she anticipates an expansion of research into other indications once products to prevent CDI recurrence are on the market. “There have been a couple of promising ulcerative colitis trials that haven’t gone anywhere clinically yet,” she said in the interview. “But will we now identify patients with UC who may be more sensitive to microbial manipulation, for whom we can use these microbial therapies along with a biologic?”

Some of her patients with IBD and CDI who are treated with FMT have not only had their CDI eradicated but have subsequently seen improvements in their IBD, she noted.

The role of traditional FMT and of stool banks will likely change in the future with new standardized oral microbiome-based therapies that can be approved and regulated by the FDA, she said. However, “we think the stool banks will still have some value,” she said, certainly for clinical research and probably for some treatment purposes as well. Regarding new therapies, “I just really hope they’re affordable,” she said.
 

Gut microbiome manipulation for cancer

Dr. Wargo’s research at MD Anderson has focused on metastatic breast cancer and immunotherapeutic checkpoint blockade. By sequencing microbiota samples and performing immune profiling in hundreds of patients, her team found that responders to PD-1 blockage have a greater diversity of gut bacteria and that “favorable signatures in the gut microbiome” are associated with enhanced immune responses in the tumor microenvironment.

Studies published last year in Science from investigators in Israel (2021 Feb 5;371[6529]:602-9) and Pittsburgh (2021 Feb 5;371[6529]:595-602), demonstrated that FMT promotes response in immunotherapy-refractory melanoma patients. In one study, FMT provided clinical benefit in 6 of 15 patients whose cancer had progressed on prior anti-PD-1 therapy, “which is pretty remarkable,” Dr. Wargo said.

Both research groups, she noted, saw favorable changes in the gut microbiome and immune cell infiltrates both at the level of the colon and the tumor.

Current research on FMT and other microbiome modulation strategies for cancer is guided in part by knowledge that tumors have microbial signatures – these signatures are now being identified across all tumor types – and by findings of “cross talk” between the gut and tumor microbiomes, she explained.

“Researchers are working hard to identify optimal consortia to enhance immune responses in the cancer setting, with promising work in preclinical models,” she said, and clinical trials are in progress. The role of diet in modulating the microbiome and enhancing anti-tumor immunity, with a focus on high dietary fiber intake, is also being investigated, she said.

Dr. Wargo reported that she serves on the advisory boards and is a paid speaker of numerous pharmaceutical and biotechnology companies, and is the coinventor of a patent submitted by the Texas MD Anderson Cancer Center on modulating the microbiome to enhance response to checkpoint blockade, and another related patent. Dr. Khanna reported that he is involved in research with Ferring/Rebiotix, Finch, Seres, Pfizer and Vendata, and does consulting for Immuron and several other companies. Dr. Kelly said she serves as an unpaid adviser for OpenBiome, a nonprofit stool bank, and that her site has enrolled patients in two of the trials testing products for CDI.

WASHINGTON – Research on standardized microbiome-based therapies designed to prevent the recurrence of Clostridioides difficile infection (CDI) is moving “with a lot of momentum,” according to one expert, and modulation of the gut microbiome may even enhance responses to immunotherapy and/or abrogate toxicity, according to another.

Several products for prevention of CDI recurrence are poised for either phase 3 trials or upcoming Food and Drug Administration approval, Sahil Khanna, MBBS, MS, professor of medicine, gastroenterology, and hepatology at the Mayo Clinic in Rochester, Minn., reported at the annual Gut Microbiota for Health World Summit.

Jennifer A. Wargo, MD, MMSc, of the University of Texas MD Anderson Cancer Center, Houston, described her investigations of microbiome modulation’s role in cancer treatment. “I used to say yes [we can do this] somewhat enthusiastically without data, but now we have data to support this,” she said at the meeting, sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility. “The answer now is totally yes.”
 

New approaches for CDI

“Based on how the field is moving, we might be able to [offer our patients] earlier microbiome restoration” than is currently afforded with fecal microbiota transplantation (FMT), he said. “Right now the [Food and Drug Administration] and our clinical guidelines say we should do FMT after three or more episodes [of CDI] – that’s heartbreaking for patients.”

Several of the microbiome-based therapies under investigation – including two poised for phase 3 trials – have shown efficacy after a second episode of CDI, and one of these two has also had positive results after one episode of CDI in patients 65 at older, a group at particularly high risk of recurrence, said Dr. Khanna.

The value of standardized, mostly pill-form microbiome therapies has been heightened during the pandemic. “We’ve been doing conventional FMT for recurrent C. difficile for over a decade now, and it’s probably the most effective treatment we have,” said Colleen R. Kelly, MD, associate professor of medicine at Brown University, Providence, R.I., and moderator of the session on microbiota-based therapies.

Prepandemic “it got really hard, with issues of identifying donors, and quality control and safety ... And then when COVID hit the stool banks shut down,” she said in an interview after the meeting. With stool testing for SARS-CoV-2 now in place, some stool is again available, “but it made me realize how fragile our current system is,” Dr. Kelly said. “The fact that companies are putting these products through the FDA pipeline and investigating them in rigorous, scientific randomized controlled trials is really good for the field.”

The products vary in composition; some are live multi-strain biotherapeutics derived from donor stool, for instance, while others are defined live bacterial consortia not from stool. Most are oral formulations, given one or multiple times, that do not require any bowel preparation.

One of the products most advanced in the pipeline, RBX2660 (Rebiotix, Ferring Pharmaceuticals) is stool derived and rectally administered. In phase 3 research, 70.5% of patients who received one active enema after having had two or more CDI recurrences and standard-of-care antibiotic treatment had no additional recurrence at 8 weeks compared to 58.1% in the placebo group, Dr. Khanna said.

The other product with positive phase 3 results, SER-109 (Seres Therapeutics), is a donor stool-derived oral formulation of purified Firmicutes spores that is administered after bowel prep. In results published earlier this year, the percentage of patients with recurrence of CDI up to 8 weeks after standard antibiotic treatment was 12% in the SER-109 group and 40% in the placebo group.

Patients in this trial were required to have had three episodes of CDI, and interestingly, Dr. Khanna said, the diagnosis of CDI was made only by toxin enzyme immunoassay (EIA). Earlier phase 2 research, which allowed either toxin EIA or polymerase chain reaction testing for the diagnosis of CDI (as other trials have done), produced negative results, leading investigators to surmise that some of the included patients had been colonized with C. difficile rather than being actively infected, Dr. Khanna said.

Researchers of these trials are documenting not only resolution of CDI but what they believe are positive shifts in the gut microbiota after microbiome-based therapy, he said. For instance, a phase 1 trial he led of the product RBX7455 (Rebiotix, Ferring Pharmaceuticals) – an oral capsule of lyophilized stool-based bacteria that can be kept for several days at room temperature – showed increases in Bacteroidia and Clostridia.

And other trials’ analyses of microbiome engraftment have demonstrated that “you can restore [species] even when these bacteria aren’t [included in the therapy],” he noted. “As the milieu of the gut improves, species that were not detected start coming back up.”

Asked about rates of efficacy in the trials’ placebo arms, Dr. Khanna said that “we’ve become smarter with our antibiotic regimens ... the placebo response rate is the response to newer guideline-based therapies.”

In addition to CDI, microbiome-based therapies are being studied, mostly in phase 1 research, for indications such as Crohn’s disease, ulcerative colitis, autism spectrum disorder, hepatitis B, and hepatic encephalopathy, Dr. Khanna noted.

Dr. Kelly, whose own research has focused on FMT for CDI, said she anticipates an expansion of research into other indications once products to prevent CDI recurrence are on the market. “There have been a couple of promising ulcerative colitis trials that haven’t gone anywhere clinically yet,” she said in the interview. “But will we now identify patients with UC who may be more sensitive to microbial manipulation, for whom we can use these microbial therapies along with a biologic?”

Some of her patients with IBD and CDI who are treated with FMT have not only had their CDI eradicated but have subsequently seen improvements in their IBD, she noted.

The role of traditional FMT and of stool banks will likely change in the future with new standardized oral microbiome-based therapies that can be approved and regulated by the FDA, she said. However, “we think the stool banks will still have some value,” she said, certainly for clinical research and probably for some treatment purposes as well. Regarding new therapies, “I just really hope they’re affordable,” she said.
 

Gut microbiome manipulation for cancer

Dr. Wargo’s research at MD Anderson has focused on metastatic breast cancer and immunotherapeutic checkpoint blockade. By sequencing microbiota samples and performing immune profiling in hundreds of patients, her team found that responders to PD-1 blockage have a greater diversity of gut bacteria and that “favorable signatures in the gut microbiome” are associated with enhanced immune responses in the tumor microenvironment.

Studies published last year in Science from investigators in Israel (2021 Feb 5;371[6529]:602-9) and Pittsburgh (2021 Feb 5;371[6529]:595-602), demonstrated that FMT promotes response in immunotherapy-refractory melanoma patients. In one study, FMT provided clinical benefit in 6 of 15 patients whose cancer had progressed on prior anti-PD-1 therapy, “which is pretty remarkable,” Dr. Wargo said.

Both research groups, she noted, saw favorable changes in the gut microbiome and immune cell infiltrates both at the level of the colon and the tumor.

Current research on FMT and other microbiome modulation strategies for cancer is guided in part by knowledge that tumors have microbial signatures – these signatures are now being identified across all tumor types – and by findings of “cross talk” between the gut and tumor microbiomes, she explained.

“Researchers are working hard to identify optimal consortia to enhance immune responses in the cancer setting, with promising work in preclinical models,” she said, and clinical trials are in progress. The role of diet in modulating the microbiome and enhancing anti-tumor immunity, with a focus on high dietary fiber intake, is also being investigated, she said.

Dr. Wargo reported that she serves on the advisory boards and is a paid speaker of numerous pharmaceutical and biotechnology companies, and is the coinventor of a patent submitted by the Texas MD Anderson Cancer Center on modulating the microbiome to enhance response to checkpoint blockade, and another related patent. Dr. Khanna reported that he is involved in research with Ferring/Rebiotix, Finch, Seres, Pfizer and Vendata, and does consulting for Immuron and several other companies. Dr. Kelly said she serves as an unpaid adviser for OpenBiome, a nonprofit stool bank, and that her site has enrolled patients in two of the trials testing products for CDI.

Sleep experts tend to agree with U.S. lawmakers about getting rid of the twice-per-year time shift, with one exception: They typically call for standard time rather than daylight saving time.

After the Senate voted unanimously on March 15 to make daylight saving time permanent, the American Academy of Sleep Medicine issued a statement that urged caution about adopting a fixed, year-round time with potential health risks.

“We do applaud stopping the switching during the course of the year and settling on a permanent time,” Jocelyn Cheng, MD, a member of the association’s public safety committee, told The Washington Post.

But “standard time, for so many scientific and circadian rationales and public health safety reasons, should really be what the permanent time is set to,” she said.

Now it’s up to the House of Representatives to decide what to do next. The legislation, which would take effect in 2023, must be passed by the House and signed by President Joe Biden before becoming a law.

Legislators and health experts have debated the shift in recent years. In 2020, the American Academy of Sleep Medicine released a position statement in the Journal of Clinical Sleep Medicine that recommended that the United States move to year-round standard time. Standard time is more aligned with humans’ circadian rhythms and natural light/dark cycles, the group wrote, and disrupting that rhythm has been linked to higher risks of heart disease, obesity, and depression.

At the same time, few studies have focused on the long-term effects of adopting daylight saving time. Most research has focused on the short-term risks of the seasonal shift, such as reduced sleep and increased car crashes, or circadian misalignment caused by other things. Some health experts have called for more research before deciding on a permanent time, the newspaper reported.

Still, the March 15 statement from sleep experts received support from more than 20 groups, including the National Safety Council, National Parent Teacher Association, and the World Sleep Society.

“We have all enjoyed those summer evenings with seemingly endless dusks,” David Neubauer, MD, an associate professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, told the Post.

But daylight saving time “does not ‘save’ evening light at all, it simply steals it from the morning, when it is necessary to maintain our healthy biological rhythms,” he said.

Permanent daylight saving time would lead to more dark mornings, which opponents have said could be dangerous for kids going to school, adults driving to work, and overall sleep cycles.

“With daylight saving time, we are perpetually out of synchronization with our internal clocks, and we often achieve less nighttime sleep, both circumstances having negative health impacts,” Dr. Neubauer said. “Extra evening light suppresses the melatonin that should be preparing us for falling asleep. The later dawn during daylight saving time deprives our biological clocks of the critical light signal.”

The pros and cons of daylight saving time and standard time were debated during a hearing held by a House Energy and Commerce subcommittee recently. Sleep experts argued in favor of standard time, while other industry experts argued for daylight saving time to reduce crime, save energy, and help businesses that benefit from more daylight in the evenings.

“Everybody advocates a permanent time, but this difference between 1 hour back or 1 hour forward is not so clear in everybody’s mind,” Dr. Cheng said. “I would like to see further debate and some due diligence done on these health consequences and public safety measures before anything else goes forward.”

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

Sleep experts tend to agree with U.S. lawmakers about getting rid of the twice-per-year time shift, with one exception: They typically call for standard time rather than daylight saving time.

After the Senate voted unanimously on March 15 to make daylight saving time permanent, the American Academy of Sleep Medicine issued a statement that urged caution about adopting a fixed, year-round time with potential health risks.

“We do applaud stopping the switching during the course of the year and settling on a permanent time,” Jocelyn Cheng, MD, a member of the association’s public safety committee, told The Washington Post.

But “standard time, for so many scientific and circadian rationales and public health safety reasons, should really be what the permanent time is set to,” she said.

Now it’s up to the House of Representatives to decide what to do next. The legislation, which would take effect in 2023, must be passed by the House and signed by President Joe Biden before becoming a law.

Legislators and health experts have debated the shift in recent years. In 2020, the American Academy of Sleep Medicine released a position statement in the Journal of Clinical Sleep Medicine that recommended that the United States move to year-round standard time. Standard time is more aligned with humans’ circadian rhythms and natural light/dark cycles, the group wrote, and disrupting that rhythm has been linked to higher risks of heart disease, obesity, and depression.

At the same time, few studies have focused on the long-term effects of adopting daylight saving time. Most research has focused on the short-term risks of the seasonal shift, such as reduced sleep and increased car crashes, or circadian misalignment caused by other things. Some health experts have called for more research before deciding on a permanent time, the newspaper reported.

Still, the March 15 statement from sleep experts received support from more than 20 groups, including the National Safety Council, National Parent Teacher Association, and the World Sleep Society.

“We have all enjoyed those summer evenings with seemingly endless dusks,” David Neubauer, MD, an associate professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, told the Post.

But daylight saving time “does not ‘save’ evening light at all, it simply steals it from the morning, when it is necessary to maintain our healthy biological rhythms,” he said.

Permanent daylight saving time would lead to more dark mornings, which opponents have said could be dangerous for kids going to school, adults driving to work, and overall sleep cycles.

“With daylight saving time, we are perpetually out of synchronization with our internal clocks, and we often achieve less nighttime sleep, both circumstances having negative health impacts,” Dr. Neubauer said. “Extra evening light suppresses the melatonin that should be preparing us for falling asleep. The later dawn during daylight saving time deprives our biological clocks of the critical light signal.”

The pros and cons of daylight saving time and standard time were debated during a hearing held by a House Energy and Commerce subcommittee recently. Sleep experts argued in favor of standard time, while other industry experts argued for daylight saving time to reduce crime, save energy, and help businesses that benefit from more daylight in the evenings.

“Everybody advocates a permanent time, but this difference between 1 hour back or 1 hour forward is not so clear in everybody’s mind,” Dr. Cheng said. “I would like to see further debate and some due diligence done on these health consequences and public safety measures before anything else goes forward.”

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

Sleep experts tend to agree with U.S. lawmakers about getting rid of the twice-per-year time shift, with one exception: They typically call for standard time rather than daylight saving time.

After the Senate voted unanimously on March 15 to make daylight saving time permanent, the American Academy of Sleep Medicine issued a statement that urged caution about adopting a fixed, year-round time with potential health risks.

“We do applaud stopping the switching during the course of the year and settling on a permanent time,” Jocelyn Cheng, MD, a member of the association’s public safety committee, told The Washington Post.

But “standard time, for so many scientific and circadian rationales and public health safety reasons, should really be what the permanent time is set to,” she said.

Now it’s up to the House of Representatives to decide what to do next. The legislation, which would take effect in 2023, must be passed by the House and signed by President Joe Biden before becoming a law.

Legislators and health experts have debated the shift in recent years. In 2020, the American Academy of Sleep Medicine released a position statement in the Journal of Clinical Sleep Medicine that recommended that the United States move to year-round standard time. Standard time is more aligned with humans’ circadian rhythms and natural light/dark cycles, the group wrote, and disrupting that rhythm has been linked to higher risks of heart disease, obesity, and depression.

At the same time, few studies have focused on the long-term effects of adopting daylight saving time. Most research has focused on the short-term risks of the seasonal shift, such as reduced sleep and increased car crashes, or circadian misalignment caused by other things. Some health experts have called for more research before deciding on a permanent time, the newspaper reported.

Still, the March 15 statement from sleep experts received support from more than 20 groups, including the National Safety Council, National Parent Teacher Association, and the World Sleep Society.

“We have all enjoyed those summer evenings with seemingly endless dusks,” David Neubauer, MD, an associate professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, told the Post.

But daylight saving time “does not ‘save’ evening light at all, it simply steals it from the morning, when it is necessary to maintain our healthy biological rhythms,” he said.

Permanent daylight saving time would lead to more dark mornings, which opponents have said could be dangerous for kids going to school, adults driving to work, and overall sleep cycles.

“With daylight saving time, we are perpetually out of synchronization with our internal clocks, and we often achieve less nighttime sleep, both circumstances having negative health impacts,” Dr. Neubauer said. “Extra evening light suppresses the melatonin that should be preparing us for falling asleep. The later dawn during daylight saving time deprives our biological clocks of the critical light signal.”

The pros and cons of daylight saving time and standard time were debated during a hearing held by a House Energy and Commerce subcommittee recently. Sleep experts argued in favor of standard time, while other industry experts argued for daylight saving time to reduce crime, save energy, and help businesses that benefit from more daylight in the evenings.

“Everybody advocates a permanent time, but this difference between 1 hour back or 1 hour forward is not so clear in everybody’s mind,” Dr. Cheng said. “I would like to see further debate and some due diligence done on these health consequences and public safety measures before anything else goes forward.”

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

A new surge in COVID-19 cases across Western Europe has led U.S. health officials to consider whether another pandemic wave will arrive soon, even as states and cities continue to lift restrictions amid low case numbers.

Infectious disease experts are watching BA.2, the Omicron subvariant that appears to be more transmissible than the original strain. BA.2 is fueling outbreaks across Europe and is growing in dominance across the United States.

“It’s picking up steam. It’s across at least 12 countries … from Finland to Greece,” Eric Topol, MD, director of the Scripps Research Translational Institute, told The Washington Post.

He has been following the surge and has posted recent charts of the outbreak on Twitter. Hospitalizations appear to be increasing in some places as well, he noted, despite the higher vaccination rates of many Western European countries.

“There’s no question there’s a significant wave there,” Dr. Topol said.

Germany recorded more than 260,000 new cases on March 15, according to the data tracker from the New York Times, but coronavirus restrictions are still being lifted this week. The U.K. is reporting more than 75,000 daily cases, and the Netherlands is reporting more than 60,000 daily cases, which are considered major numbers, compared to their population sizes. Meanwhile, France, Italy, and Switzerland are also reporting large increases in infections.

During the past 2 years, widespread outbreaks in Europe have been followed by similar surges in the U.S. weeks later. Most experts interviewed by the Post predicted that it’s likely to happen again.

In the United States, the BA.2 subvariant accounted for 23% of new COVID-19 cases for the week ending March 12, according to the latest estimate from the Centers for Disease Control and Prevention, while the original Omicron strain made up about 66% of cases. The BA.2 percentage is up from 13.7% of new cases for the week ending March 5, 7.1% the previous week, and 4.1% the week before that. In parts of the Northeast and New England, BA.2 makes up more than 38% of new cases.

At the same time, the 7 -day average of COVID-19 cases continues to drop in the United States, with about 31,000 daily cases currently, the New York Times data tracker shows. About 25,000 COVID-19 patients are hospitalized across the country, which has fallen 44% in the past 2 weeks, and about 1,200 deaths are being reported daily.

Several variables could affect the course of a future surge, the Post reported. Vaccination rates, coronavirus safety protocols, and access to antiviral medications could dictate how another wave unfolds across the country.

About 82% of the eligible U.S. population has received at least one vaccine dose, and 69% is fully vaccinated, according to the latest CDC data. About half of those who are eligible for booster doses have received one. In Germany, nearly 76% of people are fully vaccinated, the newspaper reported, and in the United Kingdom, about 74% are fully vaccinated.

Health experts are also considering how natural immunity from a previous infection could affect a BA.2 surge. Millions of Americans were infected with the original Omicron strain, BA.1, which could provide protection. That said, researchers aren’t quite sure whether BA.1 infection protects against BA.2.

“It’s like a weather alert. Right now, the skies are sunny and bright, and we hope they stay that way,” Michael Osterholm, PhD, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, told CNN.

“But we could have some bad weather by evening,” he said. “We just don’t know.”

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

A new surge in COVID-19 cases across Western Europe has led U.S. health officials to consider whether another pandemic wave will arrive soon, even as states and cities continue to lift restrictions amid low case numbers.

Infectious disease experts are watching BA.2, the Omicron subvariant that appears to be more transmissible than the original strain. BA.2 is fueling outbreaks across Europe and is growing in dominance across the United States.

“It’s picking up steam. It’s across at least 12 countries … from Finland to Greece,” Eric Topol, MD, director of the Scripps Research Translational Institute, told The Washington Post.

He has been following the surge and has posted recent charts of the outbreak on Twitter. Hospitalizations appear to be increasing in some places as well, he noted, despite the higher vaccination rates of many Western European countries.

“There’s no question there’s a significant wave there,” Dr. Topol said.

Germany recorded more than 260,000 new cases on March 15, according to the data tracker from the New York Times, but coronavirus restrictions are still being lifted this week. The U.K. is reporting more than 75,000 daily cases, and the Netherlands is reporting more than 60,000 daily cases, which are considered major numbers, compared to their population sizes. Meanwhile, France, Italy, and Switzerland are also reporting large increases in infections.

During the past 2 years, widespread outbreaks in Europe have been followed by similar surges in the U.S. weeks later. Most experts interviewed by the Post predicted that it’s likely to happen again.

In the United States, the BA.2 subvariant accounted for 23% of new COVID-19 cases for the week ending March 12, according to the latest estimate from the Centers for Disease Control and Prevention, while the original Omicron strain made up about 66% of cases. The BA.2 percentage is up from 13.7% of new cases for the week ending March 5, 7.1% the previous week, and 4.1% the week before that. In parts of the Northeast and New England, BA.2 makes up more than 38% of new cases.

At the same time, the 7 -day average of COVID-19 cases continues to drop in the United States, with about 31,000 daily cases currently, the New York Times data tracker shows. About 25,000 COVID-19 patients are hospitalized across the country, which has fallen 44% in the past 2 weeks, and about 1,200 deaths are being reported daily.

Several variables could affect the course of a future surge, the Post reported. Vaccination rates, coronavirus safety protocols, and access to antiviral medications could dictate how another wave unfolds across the country.

About 82% of the eligible U.S. population has received at least one vaccine dose, and 69% is fully vaccinated, according to the latest CDC data. About half of those who are eligible for booster doses have received one. In Germany, nearly 76% of people are fully vaccinated, the newspaper reported, and in the United Kingdom, about 74% are fully vaccinated.

Health experts are also considering how natural immunity from a previous infection could affect a BA.2 surge. Millions of Americans were infected with the original Omicron strain, BA.1, which could provide protection. That said, researchers aren’t quite sure whether BA.1 infection protects against BA.2.

“It’s like a weather alert. Right now, the skies are sunny and bright, and we hope they stay that way,” Michael Osterholm, PhD, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, told CNN.

“But we could have some bad weather by evening,” he said. “We just don’t know.”

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

A new surge in COVID-19 cases across Western Europe has led U.S. health officials to consider whether another pandemic wave will arrive soon, even as states and cities continue to lift restrictions amid low case numbers.

Infectious disease experts are watching BA.2, the Omicron subvariant that appears to be more transmissible than the original strain. BA.2 is fueling outbreaks across Europe and is growing in dominance across the United States.

“It’s picking up steam. It’s across at least 12 countries … from Finland to Greece,” Eric Topol, MD, director of the Scripps Research Translational Institute, told The Washington Post.

He has been following the surge and has posted recent charts of the outbreak on Twitter. Hospitalizations appear to be increasing in some places as well, he noted, despite the higher vaccination rates of many Western European countries.

“There’s no question there’s a significant wave there,” Dr. Topol said.

Germany recorded more than 260,000 new cases on March 15, according to the data tracker from the New York Times, but coronavirus restrictions are still being lifted this week. The U.K. is reporting more than 75,000 daily cases, and the Netherlands is reporting more than 60,000 daily cases, which are considered major numbers, compared to their population sizes. Meanwhile, France, Italy, and Switzerland are also reporting large increases in infections.

During the past 2 years, widespread outbreaks in Europe have been followed by similar surges in the U.S. weeks later. Most experts interviewed by the Post predicted that it’s likely to happen again.

In the United States, the BA.2 subvariant accounted for 23% of new COVID-19 cases for the week ending March 12, according to the latest estimate from the Centers for Disease Control and Prevention, while the original Omicron strain made up about 66% of cases. The BA.2 percentage is up from 13.7% of new cases for the week ending March 5, 7.1% the previous week, and 4.1% the week before that. In parts of the Northeast and New England, BA.2 makes up more than 38% of new cases.

At the same time, the 7 -day average of COVID-19 cases continues to drop in the United States, with about 31,000 daily cases currently, the New York Times data tracker shows. About 25,000 COVID-19 patients are hospitalized across the country, which has fallen 44% in the past 2 weeks, and about 1,200 deaths are being reported daily.

Several variables could affect the course of a future surge, the Post reported. Vaccination rates, coronavirus safety protocols, and access to antiviral medications could dictate how another wave unfolds across the country.

About 82% of the eligible U.S. population has received at least one vaccine dose, and 69% is fully vaccinated, according to the latest CDC data. About half of those who are eligible for booster doses have received one. In Germany, nearly 76% of people are fully vaccinated, the newspaper reported, and in the United Kingdom, about 74% are fully vaccinated.

Health experts are also considering how natural immunity from a previous infection could affect a BA.2 surge. Millions of Americans were infected with the original Omicron strain, BA.1, which could provide protection. That said, researchers aren’t quite sure whether BA.1 infection protects against BA.2.

“It’s like a weather alert. Right now, the skies are sunny and bright, and we hope they stay that way,” Michael Osterholm, PhD, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, told CNN.

“But we could have some bad weather by evening,” he said. “We just don’t know.”

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

This transcript of Impact Factor with F. Perry Wilson has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.

When I counsel patients who are trying to lose weight, there is something I always discuss: “Don’t drink calories.” The idea is that it is so easy to consume sweetened beverages (and alcoholic ones, for that matter) and we don’t really get a sense of how many calories we’re taking in.

Some patients balk at the idea, saying they can’t stand the taste of water or just can’t bring themselves to drink it. While, as a nephrologist, this pains me deeply to hear, I often suggest going for low- or zero-calorie flavored drinks instead of the sugary stuff.

And yet ... I need to admit that recently I’ve been more nervous about that advice. A very nice study in Nature, for example, found that artificial sweeteners induce glucose intolerance and weight gain – in mice.

Several observational studies have suggested that the use of nonnutritive sweeteners – sucralose, aspartame, and so on – are associated with higher body weight and type 2 diabetes. Of course, observational studies in this space are tricky; are people gaining weight because they are drinking so-called “diet” soda, or are they drinking diet soda because they are gaining weight?

Randomized trials, as ever, are the key to deeper understanding, but most trials in this space are relatively small. That makes a good case for this study, appearing in JAMA Network Open, which combines data from 17 randomized trials to determine what effects substituting sugary drinks with low- and zero-calorie drinks truly has.

So, what’s the bottom line? Should I ditch the Splenda in my morning coffee and drop in some sugar cubes?

It turns out that the effects of drinking low- or zero-calorie drinks instead of sugary ones is modest, but overall beneficial, depending on the outcome you’re trying to achieve.

Randomized trials show that switching to low-cal drinks reduces body weight by about a kilogram, and BMI by 0.3 points. It also reduces body fat by about half a percent.

This transcript of Impact Factor with F. Perry Wilson has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.

When I counsel patients who are trying to lose weight, there is something I always discuss: “Don’t drink calories.” The idea is that it is so easy to consume sweetened beverages (and alcoholic ones, for that matter) and we don’t really get a sense of how many calories we’re taking in.

Some patients balk at the idea, saying they can’t stand the taste of water or just can’t bring themselves to drink it. While, as a nephrologist, this pains me deeply to hear, I often suggest going for low- or zero-calorie flavored drinks instead of the sugary stuff.

And yet ... I need to admit that recently I’ve been more nervous about that advice. A very nice study in Nature, for example, found that artificial sweeteners induce glucose intolerance and weight gain – in mice.

Several observational studies have suggested that the use of nonnutritive sweeteners – sucralose, aspartame, and so on – are associated with higher body weight and type 2 diabetes. Of course, observational studies in this space are tricky; are people gaining weight because they are drinking so-called “diet” soda, or are they drinking diet soda because they are gaining weight?

Randomized trials, as ever, are the key to deeper understanding, but most trials in this space are relatively small. That makes a good case for this study, appearing in JAMA Network Open, which combines data from 17 randomized trials to determine what effects substituting sugary drinks with low- and zero-calorie drinks truly has.

So, what’s the bottom line? Should I ditch the Splenda in my morning coffee and drop in some sugar cubes?

It turns out that the effects of drinking low- or zero-calorie drinks instead of sugary ones is modest, but overall beneficial, depending on the outcome you’re trying to achieve.

Randomized trials show that switching to low-cal drinks reduces body weight by about a kilogram, and BMI by 0.3 points. It also reduces body fat by about half a percent.

This transcript of Impact Factor with F. Perry Wilson has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.

When I counsel patients who are trying to lose weight, there is something I always discuss: “Don’t drink calories.” The idea is that it is so easy to consume sweetened beverages (and alcoholic ones, for that matter) and we don’t really get a sense of how many calories we’re taking in.

Some patients balk at the idea, saying they can’t stand the taste of water or just can’t bring themselves to drink it. While, as a nephrologist, this pains me deeply to hear, I often suggest going for low- or zero-calorie flavored drinks instead of the sugary stuff.

And yet ... I need to admit that recently I’ve been more nervous about that advice. A very nice study in Nature, for example, found that artificial sweeteners induce glucose intolerance and weight gain – in mice.

Several observational studies have suggested that the use of nonnutritive sweeteners – sucralose, aspartame, and so on – are associated with higher body weight and type 2 diabetes. Of course, observational studies in this space are tricky; are people gaining weight because they are drinking so-called “diet” soda, or are they drinking diet soda because they are gaining weight?

Randomized trials, as ever, are the key to deeper understanding, but most trials in this space are relatively small. That makes a good case for this study, appearing in JAMA Network Open, which combines data from 17 randomized trials to determine what effects substituting sugary drinks with low- and zero-calorie drinks truly has.

So, what’s the bottom line? Should I ditch the Splenda in my morning coffee and drop in some sugar cubes?

It turns out that the effects of drinking low- or zero-calorie drinks instead of sugary ones is modest, but overall beneficial, depending on the outcome you’re trying to achieve.

Randomized trials show that switching to low-cal drinks reduces body weight by about a kilogram, and BMI by 0.3 points. It also reduces body fat by about half a percent.

Eat french fries every day for a month? Sure, as long as it’s for science.

That’s exactly what 107 people did in a scientific study, while 58 others ate a daily serving of almonds with the same number of calories.

At the end of the study, the researchers found no significant differences between the groups in people’s total amount of fat or their fasting glucose measures, according to the study, published Feb. 18 in the American Journal of Clinical Nutrition.

The french fry eaters gained a little more weight, but it was not statistically significant. The people who ate french fries gained 0.49 kilograms (just over a pound), vs. about a tenth of a kilogram (about one-fifth of a pound) in the group of people who ate almonds.

“The take-home is if you like almonds, eat some almonds. If you like potatoes, eat some potatoes, but don’t overeat either,” said study leader David B. Allison, PhD, a professor at Indiana University’s School of Public Health in Bloomington. ‘It’s probably good to have a little bit of each – each has some unique advantages in terms of nutrition.”

“This study confirms what registered dietitian nutritionists already know – all foods can fit. We can eat almonds, french fries, kale, and cookies,” said Melissa Majumdar, a registered dietitian and certified specialist in obesity and weight management at Emory University Hospital Midtown in Atlanta. ‘The consumption of one food or the avoidance of another does not make a healthy diet.”

At the same time, people should not interpret the results to mean it’s OK to eat french fries all day, every day. “We know that while potatoes are nutrient dense, the frying process reduces the nutritional value,” Ms. Majumdar said.

“Because french fries are often consumed alongside other nutrient-poor or high-fat foods, they should not be consumed daily but can fit into an overall balanced diet,” she added.
 

Would you like fries with that?

The researchers compared french fries to almonds because almonds are known for positive effects on energy balance, body composition, and low glycemic index. The research was partly funded by the Alliance for Potato Research and Education.

French fries are an incredibly popular food in the United States. According to an August 2021 post on the food website Mashed, Americans eat an average of 30 pounds of french fries each year.

Although consumption of almonds is increasing, Americans eat far less in volume each year than they do fries – an estimated 2.4 pounds of almonds per person, according to August 2021 figures from the Almond Board of California.

Dr. Allison and colleagues recruited 180 healthy adults for the study. Their average age was 30, and about two-thirds were women.

They randomly assigned 60 people to add about a medium serving of plain french fries (Tater Pals Ovenable Crinkle Cut Fries, Simplot Foods) to their diet. Another 60 people were assigned to the same amount of Tater Pals fries with herbs (oregano, basil, garlic, onion, and rosemary), and another 60 people ate Wonderful brand roasted and salted almonds.

Investigators told people to add either the potatoes or nuts to their diet every day for a month and gave no further instructions.

After some people dropped out of the study, results were based on 55 who ate regular french fries, 52 who ate french fries with herbs and spices, and 58 who ate the nuts.

The researchers scanned people to detect any changes in fat mass. They also measured changes in body weight, carbohydrate metabolism, and fasting blood glucose and insulin.
 

Key findings

Changes in total body fat mass and fat mass were not significantly different between the french fry groups and the almond group.

In terms of glycemic control, eating french fries for a month “is no better or worse than consuming a caloric equivalent of nuts,” the researchers noted.

Similarly, the change in total fat mass did not differ significantly among the three treatment groups.

Adding the herb and spice mix to the french fries did not make a significant difference on glycemic control, contrary to what the researchers thought might happen.

And fasting glucose, insulin, and HbA1c levels did not differ significantly between the combined french fry and almond groups. When comparisons were made among the three groups, the almond group had a lower insulin response, compared to the plain french fry group.

Many different things could be explored in future research, said study coauthor Rebecca Hanson, a registered dietitian nutritionist and research study coordinator at the University of Alabama at Birmingham. “People were not told to change their exercise or diet, so there are so many different variables,” she said. Repeating the research in people with diabetes is another possibility going forward.

The researchers acknowledged that 30 days may not have been long enough to show a significant difference. But they also noted that many previous studies were observational while they used a randomized controlled trial, considered a more robust study design.

Dr. Allison, the senior author, emphasized that this is just one study. “No one study has all the answers.

“I don’t want to tell you our results are the be all and end all or that we’ve now learned everything there is to learn about potatoes and almonds,” he said.

“Our study shows for the variables we looked at ... we did not see important, discernible differences,” he said. “That doesn’t mean if you ate 500 potatoes a day or 500 kilograms of almonds it would be the same. But at these modest levels, it doesn’t seem to make much difference.”

The study was funded by grants from the National Institutes of Health and from the Alliance for Potato Research and Education.

Asked if the industry support should be a concern, Ms. Majumdar said, “Funding from a specific food board does not necessarily dilute the results of a well-designed study. It’s not uncommon for a funding source to come from a food board that may benefit from the findings. Research money has to come from somewhere.

“This study has reputable researchers, some of the best in the field,” she said.

The U.S. produces the most almonds in the world, and California is the only state where almonds are grown commercially. Asked for the almond industry’s take on the findings, “We don’t have a comment,” said Rick Kushman, a spokesman for the Almond Board of California.

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

Eat french fries every day for a month? Sure, as long as it’s for science.

That’s exactly what 107 people did in a scientific study, while 58 others ate a daily serving of almonds with the same number of calories.

At the end of the study, the researchers found no significant differences between the groups in people’s total amount of fat or their fasting glucose measures, according to the study, published Feb. 18 in the American Journal of Clinical Nutrition.

The french fry eaters gained a little more weight, but it was not statistically significant. The people who ate french fries gained 0.49 kilograms (just over a pound), vs. about a tenth of a kilogram (about one-fifth of a pound) in the group of people who ate almonds.

“The take-home is if you like almonds, eat some almonds. If you like potatoes, eat some potatoes, but don’t overeat either,” said study leader David B. Allison, PhD, a professor at Indiana University’s School of Public Health in Bloomington. ‘It’s probably good to have a little bit of each – each has some unique advantages in terms of nutrition.”

“This study confirms what registered dietitian nutritionists already know – all foods can fit. We can eat almonds, french fries, kale, and cookies,” said Melissa Majumdar, a registered dietitian and certified specialist in obesity and weight management at Emory University Hospital Midtown in Atlanta. ‘The consumption of one food or the avoidance of another does not make a healthy diet.”

At the same time, people should not interpret the results to mean it’s OK to eat french fries all day, every day. “We know that while potatoes are nutrient dense, the frying process reduces the nutritional value,” Ms. Majumdar said.

“Because french fries are often consumed alongside other nutrient-poor or high-fat foods, they should not be consumed daily but can fit into an overall balanced diet,” she added.
 

Would you like fries with that?

The researchers compared french fries to almonds because almonds are known for positive effects on energy balance, body composition, and low glycemic index. The research was partly funded by the Alliance for Potato Research and Education.

French fries are an incredibly popular food in the United States. According to an August 2021 post on the food website Mashed, Americans eat an average of 30 pounds of french fries each year.

Although consumption of almonds is increasing, Americans eat far less in volume each year than they do fries – an estimated 2.4 pounds of almonds per person, according to August 2021 figures from the Almond Board of California.

Dr. Allison and colleagues recruited 180 healthy adults for the study. Their average age was 30, and about two-thirds were women.

They randomly assigned 60 people to add about a medium serving of plain french fries (Tater Pals Ovenable Crinkle Cut Fries, Simplot Foods) to their diet. Another 60 people were assigned to the same amount of Tater Pals fries with herbs (oregano, basil, garlic, onion, and rosemary), and another 60 people ate Wonderful brand roasted and salted almonds.

Investigators told people to add either the potatoes or nuts to their diet every day for a month and gave no further instructions.

After some people dropped out of the study, results were based on 55 who ate regular french fries, 52 who ate french fries with herbs and spices, and 58 who ate the nuts.

The researchers scanned people to detect any changes in fat mass. They also measured changes in body weight, carbohydrate metabolism, and fasting blood glucose and insulin.
 

Key findings

Changes in total body fat mass and fat mass were not significantly different between the french fry groups and the almond group.

In terms of glycemic control, eating french fries for a month “is no better or worse than consuming a caloric equivalent of nuts,” the researchers noted.

Similarly, the change in total fat mass did not differ significantly among the three treatment groups.

Adding the herb and spice mix to the french fries did not make a significant difference on glycemic control, contrary to what the researchers thought might happen.

And fasting glucose, insulin, and HbA1c levels did not differ significantly between the combined french fry and almond groups. When comparisons were made among the three groups, the almond group had a lower insulin response, compared to the plain french fry group.

Many different things could be explored in future research, said study coauthor Rebecca Hanson, a registered dietitian nutritionist and research study coordinator at the University of Alabama at Birmingham. “People were not told to change their exercise or diet, so there are so many different variables,” she said. Repeating the research in people with diabetes is another possibility going forward.

The researchers acknowledged that 30 days may not have been long enough to show a significant difference. But they also noted that many previous studies were observational while they used a randomized controlled trial, considered a more robust study design.

Dr. Allison, the senior author, emphasized that this is just one study. “No one study has all the answers.

“I don’t want to tell you our results are the be all and end all or that we’ve now learned everything there is to learn about potatoes and almonds,” he said.

“Our study shows for the variables we looked at ... we did not see important, discernible differences,” he said. “That doesn’t mean if you ate 500 potatoes a day or 500 kilograms of almonds it would be the same. But at these modest levels, it doesn’t seem to make much difference.”

The study was funded by grants from the National Institutes of Health and from the Alliance for Potato Research and Education.

Asked if the industry support should be a concern, Ms. Majumdar said, “Funding from a specific food board does not necessarily dilute the results of a well-designed study. It’s not uncommon for a funding source to come from a food board that may benefit from the findings. Research money has to come from somewhere.

“This study has reputable researchers, some of the best in the field,” she said.

The U.S. produces the most almonds in the world, and California is the only state where almonds are grown commercially. Asked for the almond industry’s take on the findings, “We don’t have a comment,” said Rick Kushman, a spokesman for the Almond Board of California.

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

Eat french fries every day for a month? Sure, as long as it’s for science.

That’s exactly what 107 people did in a scientific study, while 58 others ate a daily serving of almonds with the same number of calories.

At the end of the study, the researchers found no significant differences between the groups in people’s total amount of fat or their fasting glucose measures, according to the study, published Feb. 18 in the American Journal of Clinical Nutrition.

The french fry eaters gained a little more weight, but it was not statistically significant. The people who ate french fries gained 0.49 kilograms (just over a pound), vs. about a tenth of a kilogram (about one-fifth of a pound) in the group of people who ate almonds.

“The take-home is if you like almonds, eat some almonds. If you like potatoes, eat some potatoes, but don’t overeat either,” said study leader David B. Allison, PhD, a professor at Indiana University’s School of Public Health in Bloomington. ‘It’s probably good to have a little bit of each – each has some unique advantages in terms of nutrition.”

“This study confirms what registered dietitian nutritionists already know – all foods can fit. We can eat almonds, french fries, kale, and cookies,” said Melissa Majumdar, a registered dietitian and certified specialist in obesity and weight management at Emory University Hospital Midtown in Atlanta. ‘The consumption of one food or the avoidance of another does not make a healthy diet.”

At the same time, people should not interpret the results to mean it’s OK to eat french fries all day, every day. “We know that while potatoes are nutrient dense, the frying process reduces the nutritional value,” Ms. Majumdar said.

“Because french fries are often consumed alongside other nutrient-poor or high-fat foods, they should not be consumed daily but can fit into an overall balanced diet,” she added.
 

Would you like fries with that?

The researchers compared french fries to almonds because almonds are known for positive effects on energy balance, body composition, and low glycemic index. The research was partly funded by the Alliance for Potato Research and Education.

French fries are an incredibly popular food in the United States. According to an August 2021 post on the food website Mashed, Americans eat an average of 30 pounds of french fries each year.

Although consumption of almonds is increasing, Americans eat far less in volume each year than they do fries – an estimated 2.4 pounds of almonds per person, according to August 2021 figures from the Almond Board of California.

Dr. Allison and colleagues recruited 180 healthy adults for the study. Their average age was 30, and about two-thirds were women.

They randomly assigned 60 people to add about a medium serving of plain french fries (Tater Pals Ovenable Crinkle Cut Fries, Simplot Foods) to their diet. Another 60 people were assigned to the same amount of Tater Pals fries with herbs (oregano, basil, garlic, onion, and rosemary), and another 60 people ate Wonderful brand roasted and salted almonds.

Investigators told people to add either the potatoes or nuts to their diet every day for a month and gave no further instructions.

After some people dropped out of the study, results were based on 55 who ate regular french fries, 52 who ate french fries with herbs and spices, and 58 who ate the nuts.

The researchers scanned people to detect any changes in fat mass. They also measured changes in body weight, carbohydrate metabolism, and fasting blood glucose and insulin.
 

Key findings

Changes in total body fat mass and fat mass were not significantly different between the french fry groups and the almond group.

In terms of glycemic control, eating french fries for a month “is no better or worse than consuming a caloric equivalent of nuts,” the researchers noted.

Similarly, the change in total fat mass did not differ significantly among the three treatment groups.

Adding the herb and spice mix to the french fries did not make a significant difference on glycemic control, contrary to what the researchers thought might happen.

And fasting glucose, insulin, and HbA1c levels did not differ significantly between the combined french fry and almond groups. When comparisons were made among the three groups, the almond group had a lower insulin response, compared to the plain french fry group.

Many different things could be explored in future research, said study coauthor Rebecca Hanson, a registered dietitian nutritionist and research study coordinator at the University of Alabama at Birmingham. “People were not told to change their exercise or diet, so there are so many different variables,” she said. Repeating the research in people with diabetes is another possibility going forward.

The researchers acknowledged that 30 days may not have been long enough to show a significant difference. But they also noted that many previous studies were observational while they used a randomized controlled trial, considered a more robust study design.

Dr. Allison, the senior author, emphasized that this is just one study. “No one study has all the answers.

“I don’t want to tell you our results are the be all and end all or that we’ve now learned everything there is to learn about potatoes and almonds,” he said.

“Our study shows for the variables we looked at ... we did not see important, discernible differences,” he said. “That doesn’t mean if you ate 500 potatoes a day or 500 kilograms of almonds it would be the same. But at these modest levels, it doesn’t seem to make much difference.”

The study was funded by grants from the National Institutes of Health and from the Alliance for Potato Research and Education.

Asked if the industry support should be a concern, Ms. Majumdar said, “Funding from a specific food board does not necessarily dilute the results of a well-designed study. It’s not uncommon for a funding source to come from a food board that may benefit from the findings. Research money has to come from somewhere.

“This study has reputable researchers, some of the best in the field,” she said.

The U.S. produces the most almonds in the world, and California is the only state where almonds are grown commercially. Asked for the almond industry’s take on the findings, “We don’t have a comment,” said Rick Kushman, a spokesman for the Almond Board of California.

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

Older adults are more susceptible to adverse drug reactions because of changes in physiology, clearance, and reserves. Age-related changes that potentiate adverse drug reactions include alterations in absorption, distribution, metabolism, and excretion. As such, older patients often require adjustments in medications to optimize safety and use. Medication adjustment is especially important for older patients on complex medication regimens for multiple conditions, such as those undergoing cancer treatment. Three recent high-quality randomized trials evaluated the use of geriatric assessment (GA) in older adults with cancer.^1-3

Interdisciplinary GA can identify aging-related conditions associated with poor outcomes in older patients with cancer (e.g., toxic effects of chemotherapy) and provide recommendations aimed at improving health outcomes. The results of these trials suggest that interdisciplinary GA can improve care outcomes and oncologists’ communication for older adults with cancer, and should be considered an emerging standard of care.
 

Geriatric assessment and chemotherapy-related toxic effects

A cluster randomized trial¹ at City of Hope National Medical Center conducted between August 2015 and February 2019 enrolled 613 participants and randomly assigned them to receive a GA-guided intervention or usual standard of care in a 2-to-1 ratio. Participants were eligible for the study if they were aged ≥65 years; had a diagnosis of solid malignant neoplasm of any stage; were starting a new chemotherapy regimen; and were fluent in English, Spanish, or Chinese.

The intervention included a GA at baseline followed by assessments focused on six common areas: sleep problems, problems with eating and feeding, incontinence, confusion, evidence of falls, and skin breakdown. An interdisciplinary team (oncologist, nurse practitioner, pharmacist, physical therapist, occupational therapist, social worker, and nutritionist) performed the assessment and developed a plan of care. Interventions were multifactorial and could include referral to specialists; recommendations for medication changes; symptom management; nutritional intervention with diet recommendations and supplementation; and interventions targeting social, spiritual, and functional well-being. Follow-up by a nurse practitioner continued until completion of chemotherapy or 6 months after starting chemotherapy, whichever was earlier.

The primary outcome was grade 3 or higher chemotherapy-related toxic effects using National Cancer Institute criteria, and secondary outcomes were advance directive completion, emergency room visits and unplanned hospitalizations, and survival up to 12 months. Results showed a 10% absolute reduction in the incidence of grade 3 or higher toxic effects (P = .02), with a number needed to treat of 10. Advance directive completion also increased by 15%, but no differences were observed for other outcomes. This study offers high-quality evidence that a GA-based intervention can reduce toxic effects of chemotherapy regimens for older adults with cancer.