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PCSK9 inhibitors for severe COVID? Pilot trial signals of benefit
PCSK9 inhibitors may best be known for their powerful LDL-lowering effects but are less appreciated as anti-inflammatory agents with potential beyond cardiovascular health.
In a small pilot trial, for example, patients hospitalized with severe COVID-19 who received a single injection of PCSK9 inhibitor became less sick and more likely to survive than those given a placebo. Their 30-day risk of death or intubation fell significantly, as did their levels of the inflammatory cytokine interleukin 6 (IL-6).
Indeed, survival gains in the PCSK9-inhibitor group were greatest among patients with higher baseline concentrations of IL-6. Although the trial wasn’t powered for clinical outcomes, it suggests the drugs’ efficacy in COVID-19 tracks with intensity of inflammation, proposes a report published in the Journal of the American College of Cardiology.
Therefore, “PCSK9 inhibition may represent a novel therapeutic pathway in addition to currently recommended therapeutic approaches for severe COVID-19,” conclude the authors, led by Eliano P. Navarese, MD, PhD, Nicolaus Copernicus University, Bydgoszcz, Poland.
PCSK9 inhibitors as anti-inflammatories
Although the study was small and only hypothesis-generating, the fact that outcomes for actively treated patients were proportional to baseline IL-6 levels “strongly suggests that PCSK9 inhibition can directly modulate inflammation in COVID-19,” argues an editorial accompanying the report.
and likely sheds light on “mechanisms through which PCSK9 inhibition dually modulates lipoprotein metabolism and inflammation,” write Sascha N. Goonewardena, MD, University of Michigan, Ann Arbor, and Robert S. Rosenson, MD, Icahn School of Medicine at Mount Sinai, New York.
The results are consistent with prior evidence that the drugs are anti-inflammatory at least partly because of their interference with inflammatory pathways triggered by PCSK9 and mediated by IL-6, as described by Dr. Navarese and colleagues.
Indeed, they write, PCSK9 inhibitors may improve COVID outcomes mostly through mechanisms unrelated to LDL-receptor expression, “including direct inhibition of PCSK9-triggered inflammation.”
If true, the authors observe, it might explain “why the positive findings of the present study have not been consistently observed in trials involving other lipid-lowering agents, such as statins.” Those drugs are well-known to decrease levels of the inflammatory biomarker C-reactive protein.
In patients with stable coronary disease, in whom inflammation is typically tracked by measuring CRP, “the PCSK9 inhibitors have not been shown to have an anti-inflammatory effect,” Dr. Rosenson further explained.
But the current study’s patients with acute, severe COVID-19, a “profound inflammatory insult” with upregulation of IL-6, were “a good population” for evaluating the drugs’ potential anti-inflammatory effects, Dr. Rosenson said in an interview. The results “are quite enticing but require corroboration in a larger trial.”
A single injection
The IMPACT-SIRIO 5 trial entered 60 adults hospitalized with severe COVID-19 and elevated IL-6 at four centers in Poland. Patients with other known active infections were excluded.
They were randomly assigned double-blind to receive a 140 mg injection of evolocumab (Repatha) or placebo. The 2 groups were similar with respect to demographics, body-mass index, time since symptom onset, and treatments for managing COVID-19 and its complications.
Rates of death or need for intubation at 30 days, the primary endpoint, were 23.3% in the PCSK9-inhibitor group and 53.3% for controls, a risk difference of 30% (95% confidence interval –53.4% to –6.6%). The median durations of oxygen therapy were significantly different at 13 days and 20 days, respectively, the report states.
Serum IL-6 levels fell further over 30 days in the PCSK9-inhibitor group (–56% vs. –21% among controls). A drop by more than 90% was seen in 60% of patients in the PCSK9-inhibitor group and in 27% of controls.
The average hospital stay was shorter for those getting the PCSK9 inhibitor, compared with placebo, 16 days versus 22 days, and their 30-day mortality was numerically lower, 16% versus 33.3%.
Patients’ baseline IL-6 levels above the median, the report states, had a lower mortality on the PCSK9 inhibitor versus placebo (risk difference –37.5%; 95% CI –68.2% to –6.70%).
A larger trial to corroborate these results would potentially enter similar patients hospitalized with COVID-19 with reproducible evidence of an ongoing cytokine storm, such as elevated levels of IL-6, who would be assigned to either a PCSK9 inhibitor or placebo, Dr. Rosenson proposed.
Although the current primary endpoint that combines mortality and intubation was “reasonable” for a small pilot trial, he said, if the researchers embark on a larger study, “they’ll want to look at those events separately.”
Dr. Navarese discloses receiving speaker and consultancy fees from Amgen, Sanofi-Regeneron, Bayer; and grants from Abbott. Disclosures for the other authors are in the report. Rosenson discloses receiving research funding to his institution from Amgen, Arrowhead, Eli Lilly, Novartis, and Regeneron; consulting fees from Amgen, Arrowhead, CRISPR Therapeutics, Eli Lilly, Lipigon, Novartis, Precision Biosciences, Regeneron, Ultragenyx, and Verve; speaking fees from Amgen, Kowa, and Regeneron; and royalties from Wolters Kluwer; and owning stock in MediMergent. Dr. Goonewardena reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
PCSK9 inhibitors may best be known for their powerful LDL-lowering effects but are less appreciated as anti-inflammatory agents with potential beyond cardiovascular health.
In a small pilot trial, for example, patients hospitalized with severe COVID-19 who received a single injection of PCSK9 inhibitor became less sick and more likely to survive than those given a placebo. Their 30-day risk of death or intubation fell significantly, as did their levels of the inflammatory cytokine interleukin 6 (IL-6).
Indeed, survival gains in the PCSK9-inhibitor group were greatest among patients with higher baseline concentrations of IL-6. Although the trial wasn’t powered for clinical outcomes, it suggests the drugs’ efficacy in COVID-19 tracks with intensity of inflammation, proposes a report published in the Journal of the American College of Cardiology.
Therefore, “PCSK9 inhibition may represent a novel therapeutic pathway in addition to currently recommended therapeutic approaches for severe COVID-19,” conclude the authors, led by Eliano P. Navarese, MD, PhD, Nicolaus Copernicus University, Bydgoszcz, Poland.
PCSK9 inhibitors as anti-inflammatories
Although the study was small and only hypothesis-generating, the fact that outcomes for actively treated patients were proportional to baseline IL-6 levels “strongly suggests that PCSK9 inhibition can directly modulate inflammation in COVID-19,” argues an editorial accompanying the report.
and likely sheds light on “mechanisms through which PCSK9 inhibition dually modulates lipoprotein metabolism and inflammation,” write Sascha N. Goonewardena, MD, University of Michigan, Ann Arbor, and Robert S. Rosenson, MD, Icahn School of Medicine at Mount Sinai, New York.
The results are consistent with prior evidence that the drugs are anti-inflammatory at least partly because of their interference with inflammatory pathways triggered by PCSK9 and mediated by IL-6, as described by Dr. Navarese and colleagues.
Indeed, they write, PCSK9 inhibitors may improve COVID outcomes mostly through mechanisms unrelated to LDL-receptor expression, “including direct inhibition of PCSK9-triggered inflammation.”
If true, the authors observe, it might explain “why the positive findings of the present study have not been consistently observed in trials involving other lipid-lowering agents, such as statins.” Those drugs are well-known to decrease levels of the inflammatory biomarker C-reactive protein.
In patients with stable coronary disease, in whom inflammation is typically tracked by measuring CRP, “the PCSK9 inhibitors have not been shown to have an anti-inflammatory effect,” Dr. Rosenson further explained.
But the current study’s patients with acute, severe COVID-19, a “profound inflammatory insult” with upregulation of IL-6, were “a good population” for evaluating the drugs’ potential anti-inflammatory effects, Dr. Rosenson said in an interview. The results “are quite enticing but require corroboration in a larger trial.”
A single injection
The IMPACT-SIRIO 5 trial entered 60 adults hospitalized with severe COVID-19 and elevated IL-6 at four centers in Poland. Patients with other known active infections were excluded.
They were randomly assigned double-blind to receive a 140 mg injection of evolocumab (Repatha) or placebo. The 2 groups were similar with respect to demographics, body-mass index, time since symptom onset, and treatments for managing COVID-19 and its complications.
Rates of death or need for intubation at 30 days, the primary endpoint, were 23.3% in the PCSK9-inhibitor group and 53.3% for controls, a risk difference of 30% (95% confidence interval –53.4% to –6.6%). The median durations of oxygen therapy were significantly different at 13 days and 20 days, respectively, the report states.
Serum IL-6 levels fell further over 30 days in the PCSK9-inhibitor group (–56% vs. –21% among controls). A drop by more than 90% was seen in 60% of patients in the PCSK9-inhibitor group and in 27% of controls.
The average hospital stay was shorter for those getting the PCSK9 inhibitor, compared with placebo, 16 days versus 22 days, and their 30-day mortality was numerically lower, 16% versus 33.3%.
Patients’ baseline IL-6 levels above the median, the report states, had a lower mortality on the PCSK9 inhibitor versus placebo (risk difference –37.5%; 95% CI –68.2% to –6.70%).
A larger trial to corroborate these results would potentially enter similar patients hospitalized with COVID-19 with reproducible evidence of an ongoing cytokine storm, such as elevated levels of IL-6, who would be assigned to either a PCSK9 inhibitor or placebo, Dr. Rosenson proposed.
Although the current primary endpoint that combines mortality and intubation was “reasonable” for a small pilot trial, he said, if the researchers embark on a larger study, “they’ll want to look at those events separately.”
Dr. Navarese discloses receiving speaker and consultancy fees from Amgen, Sanofi-Regeneron, Bayer; and grants from Abbott. Disclosures for the other authors are in the report. Rosenson discloses receiving research funding to his institution from Amgen, Arrowhead, Eli Lilly, Novartis, and Regeneron; consulting fees from Amgen, Arrowhead, CRISPR Therapeutics, Eli Lilly, Lipigon, Novartis, Precision Biosciences, Regeneron, Ultragenyx, and Verve; speaking fees from Amgen, Kowa, and Regeneron; and royalties from Wolters Kluwer; and owning stock in MediMergent. Dr. Goonewardena reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
PCSK9 inhibitors may best be known for their powerful LDL-lowering effects but are less appreciated as anti-inflammatory agents with potential beyond cardiovascular health.
In a small pilot trial, for example, patients hospitalized with severe COVID-19 who received a single injection of PCSK9 inhibitor became less sick and more likely to survive than those given a placebo. Their 30-day risk of death or intubation fell significantly, as did their levels of the inflammatory cytokine interleukin 6 (IL-6).
Indeed, survival gains in the PCSK9-inhibitor group were greatest among patients with higher baseline concentrations of IL-6. Although the trial wasn’t powered for clinical outcomes, it suggests the drugs’ efficacy in COVID-19 tracks with intensity of inflammation, proposes a report published in the Journal of the American College of Cardiology.
Therefore, “PCSK9 inhibition may represent a novel therapeutic pathway in addition to currently recommended therapeutic approaches for severe COVID-19,” conclude the authors, led by Eliano P. Navarese, MD, PhD, Nicolaus Copernicus University, Bydgoszcz, Poland.
PCSK9 inhibitors as anti-inflammatories
Although the study was small and only hypothesis-generating, the fact that outcomes for actively treated patients were proportional to baseline IL-6 levels “strongly suggests that PCSK9 inhibition can directly modulate inflammation in COVID-19,” argues an editorial accompanying the report.
and likely sheds light on “mechanisms through which PCSK9 inhibition dually modulates lipoprotein metabolism and inflammation,” write Sascha N. Goonewardena, MD, University of Michigan, Ann Arbor, and Robert S. Rosenson, MD, Icahn School of Medicine at Mount Sinai, New York.
The results are consistent with prior evidence that the drugs are anti-inflammatory at least partly because of their interference with inflammatory pathways triggered by PCSK9 and mediated by IL-6, as described by Dr. Navarese and colleagues.
Indeed, they write, PCSK9 inhibitors may improve COVID outcomes mostly through mechanisms unrelated to LDL-receptor expression, “including direct inhibition of PCSK9-triggered inflammation.”
If true, the authors observe, it might explain “why the positive findings of the present study have not been consistently observed in trials involving other lipid-lowering agents, such as statins.” Those drugs are well-known to decrease levels of the inflammatory biomarker C-reactive protein.
In patients with stable coronary disease, in whom inflammation is typically tracked by measuring CRP, “the PCSK9 inhibitors have not been shown to have an anti-inflammatory effect,” Dr. Rosenson further explained.
But the current study’s patients with acute, severe COVID-19, a “profound inflammatory insult” with upregulation of IL-6, were “a good population” for evaluating the drugs’ potential anti-inflammatory effects, Dr. Rosenson said in an interview. The results “are quite enticing but require corroboration in a larger trial.”
A single injection
The IMPACT-SIRIO 5 trial entered 60 adults hospitalized with severe COVID-19 and elevated IL-6 at four centers in Poland. Patients with other known active infections were excluded.
They were randomly assigned double-blind to receive a 140 mg injection of evolocumab (Repatha) or placebo. The 2 groups were similar with respect to demographics, body-mass index, time since symptom onset, and treatments for managing COVID-19 and its complications.
Rates of death or need for intubation at 30 days, the primary endpoint, were 23.3% in the PCSK9-inhibitor group and 53.3% for controls, a risk difference of 30% (95% confidence interval –53.4% to –6.6%). The median durations of oxygen therapy were significantly different at 13 days and 20 days, respectively, the report states.
Serum IL-6 levels fell further over 30 days in the PCSK9-inhibitor group (–56% vs. –21% among controls). A drop by more than 90% was seen in 60% of patients in the PCSK9-inhibitor group and in 27% of controls.
The average hospital stay was shorter for those getting the PCSK9 inhibitor, compared with placebo, 16 days versus 22 days, and their 30-day mortality was numerically lower, 16% versus 33.3%.
Patients’ baseline IL-6 levels above the median, the report states, had a lower mortality on the PCSK9 inhibitor versus placebo (risk difference –37.5%; 95% CI –68.2% to –6.70%).
A larger trial to corroborate these results would potentially enter similar patients hospitalized with COVID-19 with reproducible evidence of an ongoing cytokine storm, such as elevated levels of IL-6, who would be assigned to either a PCSK9 inhibitor or placebo, Dr. Rosenson proposed.
Although the current primary endpoint that combines mortality and intubation was “reasonable” for a small pilot trial, he said, if the researchers embark on a larger study, “they’ll want to look at those events separately.”
Dr. Navarese discloses receiving speaker and consultancy fees from Amgen, Sanofi-Regeneron, Bayer; and grants from Abbott. Disclosures for the other authors are in the report. Rosenson discloses receiving research funding to his institution from Amgen, Arrowhead, Eli Lilly, Novartis, and Regeneron; consulting fees from Amgen, Arrowhead, CRISPR Therapeutics, Eli Lilly, Lipigon, Novartis, Precision Biosciences, Regeneron, Ultragenyx, and Verve; speaking fees from Amgen, Kowa, and Regeneron; and royalties from Wolters Kluwer; and owning stock in MediMergent. Dr. Goonewardena reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FDA approves new type 2 diabetes drug bexagliflozin
The U.S. Food and Drug Administration has approved bexagliflozin (Brenzavvy, TheracosBio) for the treatment of adults with type 2 diabetes.
The once-daily 20-mg oral sodium-glucose cotransporter 2 (SGLT2) inhibitor is indicated as an adjunct to diet and exercise to improve glycemic control for those with type 2 diabetes, but not type 1 diabetes. It can be used in adults with an estimated glomerular filtration rate (eGFR) > 30 mL/min per 1.73 m2.
Approval was based on results from 23 clinical trials with more than 5,000 participants, including more than 300 patients with stage 3 kidney disease (eGFR < 60 and > 30 mL/min per 1.73 m2).
In the phase 3 studies, bexagliflozin significantly reduced hemoglobin A1c and fasting blood glucose at 24 weeks as monotherapy or as add-on to metformin and other glucose-lowering drugs and combinations. It also produced modest reductions in body weight and systolic blood pressure.
In the phase 3 Bexagliflozin Efficacy and Safety Trial (BEST) cardiovascular outcomes trial, the drug met its efficacy and safety objectives in patients at high cardiovascular risk. Noninferiority was demonstrated for the composite outcome of cardiovascular death, myocardial infarction, stroke, or unstable angina.
“As a class of drugs, SGLT2 inhibitors have shown tremendous benefit in treating adults with type 2 diabetes,” said Mason Freeman, MD, director of the Translational Research Center at Massachusetts General Hospital, Boston, in a press release from TheracosBio.
“Being involved in all of the clinical trials for Brenzavvy, I am greatly impressed with the efficacy of the drug in reducing blood glucose levels and I believe it is an important addition to the SGLT2 inhibitor class of drugs.”
As with other SGLT2 inhibitors, adverse events seen in the trials include ketoacidosis, lower limb amputation, volume depletion, urosepsis, pyelonephritis, Fournier’s gangrene, genital mycotic infections, and hypoglycemia when used with insulin or insulin secretagogues.
Bexagliflozin joins an already crowded field of SGLT2 inhibitors, some of which have been approved for additional cardiovascular and kidney indications.
Of interest, bexagliflozin was approved by the FDA for diabetes in cats in December 2022, as the first oral new animal drug to improve glycemic control in otherwise healthy cats with diabetes not previously treated with insulin.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved bexagliflozin (Brenzavvy, TheracosBio) for the treatment of adults with type 2 diabetes.
The once-daily 20-mg oral sodium-glucose cotransporter 2 (SGLT2) inhibitor is indicated as an adjunct to diet and exercise to improve glycemic control for those with type 2 diabetes, but not type 1 diabetes. It can be used in adults with an estimated glomerular filtration rate (eGFR) > 30 mL/min per 1.73 m2.
Approval was based on results from 23 clinical trials with more than 5,000 participants, including more than 300 patients with stage 3 kidney disease (eGFR < 60 and > 30 mL/min per 1.73 m2).
In the phase 3 studies, bexagliflozin significantly reduced hemoglobin A1c and fasting blood glucose at 24 weeks as monotherapy or as add-on to metformin and other glucose-lowering drugs and combinations. It also produced modest reductions in body weight and systolic blood pressure.
In the phase 3 Bexagliflozin Efficacy and Safety Trial (BEST) cardiovascular outcomes trial, the drug met its efficacy and safety objectives in patients at high cardiovascular risk. Noninferiority was demonstrated for the composite outcome of cardiovascular death, myocardial infarction, stroke, or unstable angina.
“As a class of drugs, SGLT2 inhibitors have shown tremendous benefit in treating adults with type 2 diabetes,” said Mason Freeman, MD, director of the Translational Research Center at Massachusetts General Hospital, Boston, in a press release from TheracosBio.
“Being involved in all of the clinical trials for Brenzavvy, I am greatly impressed with the efficacy of the drug in reducing blood glucose levels and I believe it is an important addition to the SGLT2 inhibitor class of drugs.”
As with other SGLT2 inhibitors, adverse events seen in the trials include ketoacidosis, lower limb amputation, volume depletion, urosepsis, pyelonephritis, Fournier’s gangrene, genital mycotic infections, and hypoglycemia when used with insulin or insulin secretagogues.
Bexagliflozin joins an already crowded field of SGLT2 inhibitors, some of which have been approved for additional cardiovascular and kidney indications.
Of interest, bexagliflozin was approved by the FDA for diabetes in cats in December 2022, as the first oral new animal drug to improve glycemic control in otherwise healthy cats with diabetes not previously treated with insulin.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved bexagliflozin (Brenzavvy, TheracosBio) for the treatment of adults with type 2 diabetes.
The once-daily 20-mg oral sodium-glucose cotransporter 2 (SGLT2) inhibitor is indicated as an adjunct to diet and exercise to improve glycemic control for those with type 2 diabetes, but not type 1 diabetes. It can be used in adults with an estimated glomerular filtration rate (eGFR) > 30 mL/min per 1.73 m2.
Approval was based on results from 23 clinical trials with more than 5,000 participants, including more than 300 patients with stage 3 kidney disease (eGFR < 60 and > 30 mL/min per 1.73 m2).
In the phase 3 studies, bexagliflozin significantly reduced hemoglobin A1c and fasting blood glucose at 24 weeks as monotherapy or as add-on to metformin and other glucose-lowering drugs and combinations. It also produced modest reductions in body weight and systolic blood pressure.
In the phase 3 Bexagliflozin Efficacy and Safety Trial (BEST) cardiovascular outcomes trial, the drug met its efficacy and safety objectives in patients at high cardiovascular risk. Noninferiority was demonstrated for the composite outcome of cardiovascular death, myocardial infarction, stroke, or unstable angina.
“As a class of drugs, SGLT2 inhibitors have shown tremendous benefit in treating adults with type 2 diabetes,” said Mason Freeman, MD, director of the Translational Research Center at Massachusetts General Hospital, Boston, in a press release from TheracosBio.
“Being involved in all of the clinical trials for Brenzavvy, I am greatly impressed with the efficacy of the drug in reducing blood glucose levels and I believe it is an important addition to the SGLT2 inhibitor class of drugs.”
As with other SGLT2 inhibitors, adverse events seen in the trials include ketoacidosis, lower limb amputation, volume depletion, urosepsis, pyelonephritis, Fournier’s gangrene, genital mycotic infections, and hypoglycemia when used with insulin or insulin secretagogues.
Bexagliflozin joins an already crowded field of SGLT2 inhibitors, some of which have been approved for additional cardiovascular and kidney indications.
Of interest, bexagliflozin was approved by the FDA for diabetes in cats in December 2022, as the first oral new animal drug to improve glycemic control in otherwise healthy cats with diabetes not previously treated with insulin.
A version of this article first appeared on Medscape.com.
Doctors’ happiness has not rebounded as pandemic drags on
Physicians reported similar levels of unhappiness in 2022 too.
Fewer than half of physicians said they were currently somewhat or very happy at work, compared with 75% of physicians who said they were somewhat or very happy at work in a previous survey conducted before the pandemic, the new Medscape Physician Lifestyle & Happiness Report 2023 shows.*
“I am not surprised that we’re less happy now,” said Amaryllis Sánchez, MD, a board-certified family medicine physician and a certified physician coach.
“I speak to physicians around the country and I hear that their workplaces are understaffed, they’re overworked and they don’t feel safe. Although we’re in a different phase of the pandemic, doctors feel that the ground beneath them is still shaky,” said Dr. Sánchez, the author of “Recapturing Joy in Medicine.”
Most doctors are seeing more patients than they can handle and are expected to do that consistently. “When you no longer have the capacity to give of yourself, that becomes a nearly impossible task,” said Dr. Sánchez.
Also, physicians in understaffed workplaces often must take on additional work such as administrative or nursing duties, said Katie Cole, DO, a board-certified psychiatrist and a physician coach.
While health systems are aware that physicians need time to rest and recharge, staffing shortages prevent doctors from taking time off because they can’t find coverage, said Dr. Cole.
“While we know that it’s important for physicians to take vacations, more than one-third of doctors still take 2 weeks or less of vacation annually,” said Dr. Cole.
Physicians also tend to have less compassion for themselves and sacrifice self-care compared to other health care workers. “When a patient dies, nurses get together, debrief, and hug each other, whereas doctors have another patient to see. The culture of medicine doesn’t support self-compassion for physicians,” said Dr. Cole.
Physicians also felt less safe at work during the pandemic because of to shortages of personal protective equipment, said Dr. Sánchez. They have also witnessed or experienced an increase in abusive behavior, violence and threats of violence.
Physicians’ personal life suffers
Doctors maintain their mental health primarily by spending time with family members and friends, according to 2022’s Medscape Physician Lifestyle & Happiness Report. Yet half of doctors reported in a survey by the Physicians Foundation that they withdrew from family, friends or coworkers in 2022, said Dr. Sánchez.
“When you exceed your mental, emotional, and physical capacity at work, you have no reserve left for your personal life,” said Dr. Cole.
That may explain why only 58% of doctors reported feeling somewhat or very happy outside of work, compared with 84% who felt that way before the pandemic.
More women doctors said they deal with stronger feelings of conflict in trying to balance parenting responsibilities with a highly demanding job. Nearly one in two women physician-parents reported feeling very conflicted at work, compared with about one in four male physician-parents.
When physicians go home, they may be emotionally drained and tired mentally from making a lot of decisions at work, said Dr. Cole.
“As a woman, if you have children and a husband and you’re responsible for dinner, picking up the kids at daycare or helping them with homework, and making all these decisions when you get home, it’s overwhelming,” said Dr. Cole.
Prioritize your well-being
Doctors need to prioritize their own well-being, said Dr. Sánchez. “That’s not being selfish, that’s doing what’s necessary to stay well and be able to take care of patients. If doctors don’t take care of themselves, no one else will.”
Dr. Sánchez recommended that doctors regularly interact with relatives, friends, trusted colleagues, or clergy to help maintain their well-being, rather than waiting until a crisis to reach out.
A good coach, mentor, or counselor can help physicians gain enough self-awareness to handle their emotions and gain more clarity about what changes need to be made, she said.
Dr. Cole suggested that doctors figure out what makes them happy and fulfilled at work and try to spend more time on that activity. “Knowing what makes you happy and your strengths are foundational for creating a life you love.”
She urged doctors to “start thinking now about what you love about medicine and what is going right at home, and what areas you want to change. Then, start advocating for your needs.”
A version of this article originally appeared on Medscape.com.
Correction, 1/26/23: An earlier version of this article misstated the findings of the survey.
Physicians reported similar levels of unhappiness in 2022 too.
Fewer than half of physicians said they were currently somewhat or very happy at work, compared with 75% of physicians who said they were somewhat or very happy at work in a previous survey conducted before the pandemic, the new Medscape Physician Lifestyle & Happiness Report 2023 shows.*
“I am not surprised that we’re less happy now,” said Amaryllis Sánchez, MD, a board-certified family medicine physician and a certified physician coach.
“I speak to physicians around the country and I hear that their workplaces are understaffed, they’re overworked and they don’t feel safe. Although we’re in a different phase of the pandemic, doctors feel that the ground beneath them is still shaky,” said Dr. Sánchez, the author of “Recapturing Joy in Medicine.”
Most doctors are seeing more patients than they can handle and are expected to do that consistently. “When you no longer have the capacity to give of yourself, that becomes a nearly impossible task,” said Dr. Sánchez.
Also, physicians in understaffed workplaces often must take on additional work such as administrative or nursing duties, said Katie Cole, DO, a board-certified psychiatrist and a physician coach.
While health systems are aware that physicians need time to rest and recharge, staffing shortages prevent doctors from taking time off because they can’t find coverage, said Dr. Cole.
“While we know that it’s important for physicians to take vacations, more than one-third of doctors still take 2 weeks or less of vacation annually,” said Dr. Cole.
Physicians also tend to have less compassion for themselves and sacrifice self-care compared to other health care workers. “When a patient dies, nurses get together, debrief, and hug each other, whereas doctors have another patient to see. The culture of medicine doesn’t support self-compassion for physicians,” said Dr. Cole.
Physicians also felt less safe at work during the pandemic because of to shortages of personal protective equipment, said Dr. Sánchez. They have also witnessed or experienced an increase in abusive behavior, violence and threats of violence.
Physicians’ personal life suffers
Doctors maintain their mental health primarily by spending time with family members and friends, according to 2022’s Medscape Physician Lifestyle & Happiness Report. Yet half of doctors reported in a survey by the Physicians Foundation that they withdrew from family, friends or coworkers in 2022, said Dr. Sánchez.
“When you exceed your mental, emotional, and physical capacity at work, you have no reserve left for your personal life,” said Dr. Cole.
That may explain why only 58% of doctors reported feeling somewhat or very happy outside of work, compared with 84% who felt that way before the pandemic.
More women doctors said they deal with stronger feelings of conflict in trying to balance parenting responsibilities with a highly demanding job. Nearly one in two women physician-parents reported feeling very conflicted at work, compared with about one in four male physician-parents.
When physicians go home, they may be emotionally drained and tired mentally from making a lot of decisions at work, said Dr. Cole.
“As a woman, if you have children and a husband and you’re responsible for dinner, picking up the kids at daycare or helping them with homework, and making all these decisions when you get home, it’s overwhelming,” said Dr. Cole.
Prioritize your well-being
Doctors need to prioritize their own well-being, said Dr. Sánchez. “That’s not being selfish, that’s doing what’s necessary to stay well and be able to take care of patients. If doctors don’t take care of themselves, no one else will.”
Dr. Sánchez recommended that doctors regularly interact with relatives, friends, trusted colleagues, or clergy to help maintain their well-being, rather than waiting until a crisis to reach out.
A good coach, mentor, or counselor can help physicians gain enough self-awareness to handle their emotions and gain more clarity about what changes need to be made, she said.
Dr. Cole suggested that doctors figure out what makes them happy and fulfilled at work and try to spend more time on that activity. “Knowing what makes you happy and your strengths are foundational for creating a life you love.”
She urged doctors to “start thinking now about what you love about medicine and what is going right at home, and what areas you want to change. Then, start advocating for your needs.”
A version of this article originally appeared on Medscape.com.
Correction, 1/26/23: An earlier version of this article misstated the findings of the survey.
Physicians reported similar levels of unhappiness in 2022 too.
Fewer than half of physicians said they were currently somewhat or very happy at work, compared with 75% of physicians who said they were somewhat or very happy at work in a previous survey conducted before the pandemic, the new Medscape Physician Lifestyle & Happiness Report 2023 shows.*
“I am not surprised that we’re less happy now,” said Amaryllis Sánchez, MD, a board-certified family medicine physician and a certified physician coach.
“I speak to physicians around the country and I hear that their workplaces are understaffed, they’re overworked and they don’t feel safe. Although we’re in a different phase of the pandemic, doctors feel that the ground beneath them is still shaky,” said Dr. Sánchez, the author of “Recapturing Joy in Medicine.”
Most doctors are seeing more patients than they can handle and are expected to do that consistently. “When you no longer have the capacity to give of yourself, that becomes a nearly impossible task,” said Dr. Sánchez.
Also, physicians in understaffed workplaces often must take on additional work such as administrative or nursing duties, said Katie Cole, DO, a board-certified psychiatrist and a physician coach.
While health systems are aware that physicians need time to rest and recharge, staffing shortages prevent doctors from taking time off because they can’t find coverage, said Dr. Cole.
“While we know that it’s important for physicians to take vacations, more than one-third of doctors still take 2 weeks or less of vacation annually,” said Dr. Cole.
Physicians also tend to have less compassion for themselves and sacrifice self-care compared to other health care workers. “When a patient dies, nurses get together, debrief, and hug each other, whereas doctors have another patient to see. The culture of medicine doesn’t support self-compassion for physicians,” said Dr. Cole.
Physicians also felt less safe at work during the pandemic because of to shortages of personal protective equipment, said Dr. Sánchez. They have also witnessed or experienced an increase in abusive behavior, violence and threats of violence.
Physicians’ personal life suffers
Doctors maintain their mental health primarily by spending time with family members and friends, according to 2022’s Medscape Physician Lifestyle & Happiness Report. Yet half of doctors reported in a survey by the Physicians Foundation that they withdrew from family, friends or coworkers in 2022, said Dr. Sánchez.
“When you exceed your mental, emotional, and physical capacity at work, you have no reserve left for your personal life,” said Dr. Cole.
That may explain why only 58% of doctors reported feeling somewhat or very happy outside of work, compared with 84% who felt that way before the pandemic.
More women doctors said they deal with stronger feelings of conflict in trying to balance parenting responsibilities with a highly demanding job. Nearly one in two women physician-parents reported feeling very conflicted at work, compared with about one in four male physician-parents.
When physicians go home, they may be emotionally drained and tired mentally from making a lot of decisions at work, said Dr. Cole.
“As a woman, if you have children and a husband and you’re responsible for dinner, picking up the kids at daycare or helping them with homework, and making all these decisions when you get home, it’s overwhelming,” said Dr. Cole.
Prioritize your well-being
Doctors need to prioritize their own well-being, said Dr. Sánchez. “That’s not being selfish, that’s doing what’s necessary to stay well and be able to take care of patients. If doctors don’t take care of themselves, no one else will.”
Dr. Sánchez recommended that doctors regularly interact with relatives, friends, trusted colleagues, or clergy to help maintain their well-being, rather than waiting until a crisis to reach out.
A good coach, mentor, or counselor can help physicians gain enough self-awareness to handle their emotions and gain more clarity about what changes need to be made, she said.
Dr. Cole suggested that doctors figure out what makes them happy and fulfilled at work and try to spend more time on that activity. “Knowing what makes you happy and your strengths are foundational for creating a life you love.”
She urged doctors to “start thinking now about what you love about medicine and what is going right at home, and what areas you want to change. Then, start advocating for your needs.”
A version of this article originally appeared on Medscape.com.
Correction, 1/26/23: An earlier version of this article misstated the findings of the survey.
A patient named ‘Settle’ decides to sue instead
On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.
Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.
Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.
Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.
Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.
His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.
Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.
Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.
Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”
His suit seeks not only compensatory damages and other relief but also punitive damages.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article originally appeared on Medscape.com.
On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.
Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.
Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.
Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.
Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.
His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.
Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.
Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.
Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”
His suit seeks not only compensatory damages and other relief but also punitive damages.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article originally appeared on Medscape.com.
On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.
Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.
Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.
Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.
Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.
His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.
Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.
Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.
Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”
His suit seeks not only compensatory damages and other relief but also punitive damages.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article originally appeared on Medscape.com.
Not all white coats are doctors: Why titles are important at the doctor’s office
says Cyndy Flores, a physician assistant (PA) in the emergency department at Vituity, Emeryville, Calif. “Sometimes, I can go through a complete history and physical, explain a treatment plan, and perform a procedure, and [the patient] will say, ‘Thank you, doctor.’ ”
“I always come back and say, ‘You’re very welcome, but my name is Cyndy, and I’m the PA.’ ”
Ms. Flores is used to patients calling her “doctor” when she greets them. She typically offers a quick correction and moves on with the appointment.
With 355,000 nurse practitioners (NPs) and 149,000 certified PAs practicing in the United States, it’s more common than ever for health care providers who don’t go by the title “doctor” to diagnose and treat patients.
A recent report, Evolving Scope of Practice, found that more than 70% of physicians were “somewhat satisfied to very satisfied” with patient treatment by PAs and NPs.
But for patients, having a health care team that includes physicians, NPs, and PAs can be confusing. Additionally, it creates a need for education about their correct titles and roles in patient care.
“It’s really important for patients to understand who is taking care of them,” Ms. Flores says.
Education starts in your practice
Educating patients about the roles of different providers on their health care team starts long before patients enter the exam room, Ms. Flores explains.
Some patients may not understand the difference, some may just forget because they’re used to calling all providers doctors, and others may find it awkward to use a provider’s first name or not know the respectful way to address an NP or a PA.
Practices can help by listing the names and biographies of the health care team on the clinic website. In addition, when patients call for an appointment, Ms. Flores believes front desk staff can reinforce that information. When offering appointments with a physician, NP, or PA, clearly use the practitioner’s title and reiterate it throughout the conversation. For example, “Would you like to see our nurse practitioner, Alice Smith, next week?” or “So, our physician assistant Mrs. Jones will see you Friday at 3 PM.”
The report also found that 76% of patients expressed a preference to see a physician over a PA, and 71% expressed a preference to see a physician over an NP, but offering appointments with nonphysician providers is part of the education process.
“Some families are super savvy and know the differences between nurse practitioners, physician assistants, and doctors, and ... there are families who don’t understand those titles, [and] we need to explain what they do in our practice,” adds Nicole Aaronson, MD, MBA, attending surgeon at Nemours Children’s Health of Delaware. Dr. Aaronson believes there’s an opportunity for educating patients when speaking about all the available providers they may see.
Hanging posters or using brochures in the clinic or hospital is another effective way to reinforce the roles of various providers on the care team. Include biographies and educational information on practice materials and video programs running in the waiting room.
“Patients mean it [calling everyone doctor] as a way to respectfully address the nurse practitioner or physician assistant rather than meaning it as a denigration of the physician,” Dr. Aaronson says. “But everyone appreciates being called by the correct title.”
Helping patients understand the members of their care team and the correct titles to use for those health care professionals could also help patients feel more confident about their health care experience.
“Patients really like knowing that there are specialists in each of the areas taking care of them,” Ms. Flores says. “I think that conveys a feeling of trust in your provider.”
Not everyone is a doctor
Even when PAs and NPs remind patients of their roles and reinforce the use of their preferred names, there will still be patients who continue referring to their nonphysician provider as “doctor.”
“There’s a perception that anyone who walks into a room with a stethoscope is your doctor,” says Graig Straus, DNP, an NP and president and CEO of Rockland Urgent Care Family Health NP, P.C., West Haverstraw, N.Y. “You do get a little bit of burnout correcting people all the time.”
Dr. Straus, who earned his doctorate in nursing practice, notes that patients using the honorific with him aren’t incorrect, but he still educates them on his role within the health care team.
“NPs and PAs have a valuable role to play independently and in concert with the physician,” Dr. Aaronson says. This understanding is essential, as states consider expanding treatment abilities for NPs and PAs.
NPs have expanded treatment abilities or full practice authority in almost half the states, and 31% of the physicians surveyed agreed that NPs should have expanded treatment abilities.
An estimated 1 in 5 states characterizes the physician-PA relationship as collaborative, not supervisory, according to the American Academy of Physician Associates. At the same time, only 39% of physicians surveyed said they favored this trend.
“Patients need great quality care, and there are many different types of providers that can provide that care as part of the team,” Ms. Flores says. “When you have a team taking care of a patient, that patient [gets] the best care possible – and ... that’s why we went into medicine: to deliver high-quality, compassionate care to our patients, and we should all be in this together.”
When practices do their part explaining who is and isn’t a doctor and what each provider’s title and role is and what to call them, and everyone reinforces it, health care becomes not only more manageable for patients to traverse but easier to understand, leading to a better experience.
A version of this article first appeared on Medscape.com.
says Cyndy Flores, a physician assistant (PA) in the emergency department at Vituity, Emeryville, Calif. “Sometimes, I can go through a complete history and physical, explain a treatment plan, and perform a procedure, and [the patient] will say, ‘Thank you, doctor.’ ”
“I always come back and say, ‘You’re very welcome, but my name is Cyndy, and I’m the PA.’ ”
Ms. Flores is used to patients calling her “doctor” when she greets them. She typically offers a quick correction and moves on with the appointment.
With 355,000 nurse practitioners (NPs) and 149,000 certified PAs practicing in the United States, it’s more common than ever for health care providers who don’t go by the title “doctor” to diagnose and treat patients.
A recent report, Evolving Scope of Practice, found that more than 70% of physicians were “somewhat satisfied to very satisfied” with patient treatment by PAs and NPs.
But for patients, having a health care team that includes physicians, NPs, and PAs can be confusing. Additionally, it creates a need for education about their correct titles and roles in patient care.
“It’s really important for patients to understand who is taking care of them,” Ms. Flores says.
Education starts in your practice
Educating patients about the roles of different providers on their health care team starts long before patients enter the exam room, Ms. Flores explains.
Some patients may not understand the difference, some may just forget because they’re used to calling all providers doctors, and others may find it awkward to use a provider’s first name or not know the respectful way to address an NP or a PA.
Practices can help by listing the names and biographies of the health care team on the clinic website. In addition, when patients call for an appointment, Ms. Flores believes front desk staff can reinforce that information. When offering appointments with a physician, NP, or PA, clearly use the practitioner’s title and reiterate it throughout the conversation. For example, “Would you like to see our nurse practitioner, Alice Smith, next week?” or “So, our physician assistant Mrs. Jones will see you Friday at 3 PM.”
The report also found that 76% of patients expressed a preference to see a physician over a PA, and 71% expressed a preference to see a physician over an NP, but offering appointments with nonphysician providers is part of the education process.
“Some families are super savvy and know the differences between nurse practitioners, physician assistants, and doctors, and ... there are families who don’t understand those titles, [and] we need to explain what they do in our practice,” adds Nicole Aaronson, MD, MBA, attending surgeon at Nemours Children’s Health of Delaware. Dr. Aaronson believes there’s an opportunity for educating patients when speaking about all the available providers they may see.
Hanging posters or using brochures in the clinic or hospital is another effective way to reinforce the roles of various providers on the care team. Include biographies and educational information on practice materials and video programs running in the waiting room.
“Patients mean it [calling everyone doctor] as a way to respectfully address the nurse practitioner or physician assistant rather than meaning it as a denigration of the physician,” Dr. Aaronson says. “But everyone appreciates being called by the correct title.”
Helping patients understand the members of their care team and the correct titles to use for those health care professionals could also help patients feel more confident about their health care experience.
“Patients really like knowing that there are specialists in each of the areas taking care of them,” Ms. Flores says. “I think that conveys a feeling of trust in your provider.”
Not everyone is a doctor
Even when PAs and NPs remind patients of their roles and reinforce the use of their preferred names, there will still be patients who continue referring to their nonphysician provider as “doctor.”
“There’s a perception that anyone who walks into a room with a stethoscope is your doctor,” says Graig Straus, DNP, an NP and president and CEO of Rockland Urgent Care Family Health NP, P.C., West Haverstraw, N.Y. “You do get a little bit of burnout correcting people all the time.”
Dr. Straus, who earned his doctorate in nursing practice, notes that patients using the honorific with him aren’t incorrect, but he still educates them on his role within the health care team.
“NPs and PAs have a valuable role to play independently and in concert with the physician,” Dr. Aaronson says. This understanding is essential, as states consider expanding treatment abilities for NPs and PAs.
NPs have expanded treatment abilities or full practice authority in almost half the states, and 31% of the physicians surveyed agreed that NPs should have expanded treatment abilities.
An estimated 1 in 5 states characterizes the physician-PA relationship as collaborative, not supervisory, according to the American Academy of Physician Associates. At the same time, only 39% of physicians surveyed said they favored this trend.
“Patients need great quality care, and there are many different types of providers that can provide that care as part of the team,” Ms. Flores says. “When you have a team taking care of a patient, that patient [gets] the best care possible – and ... that’s why we went into medicine: to deliver high-quality, compassionate care to our patients, and we should all be in this together.”
When practices do their part explaining who is and isn’t a doctor and what each provider’s title and role is and what to call them, and everyone reinforces it, health care becomes not only more manageable for patients to traverse but easier to understand, leading to a better experience.
A version of this article first appeared on Medscape.com.
says Cyndy Flores, a physician assistant (PA) in the emergency department at Vituity, Emeryville, Calif. “Sometimes, I can go through a complete history and physical, explain a treatment plan, and perform a procedure, and [the patient] will say, ‘Thank you, doctor.’ ”
“I always come back and say, ‘You’re very welcome, but my name is Cyndy, and I’m the PA.’ ”
Ms. Flores is used to patients calling her “doctor” when she greets them. She typically offers a quick correction and moves on with the appointment.
With 355,000 nurse practitioners (NPs) and 149,000 certified PAs practicing in the United States, it’s more common than ever for health care providers who don’t go by the title “doctor” to diagnose and treat patients.
A recent report, Evolving Scope of Practice, found that more than 70% of physicians were “somewhat satisfied to very satisfied” with patient treatment by PAs and NPs.
But for patients, having a health care team that includes physicians, NPs, and PAs can be confusing. Additionally, it creates a need for education about their correct titles and roles in patient care.
“It’s really important for patients to understand who is taking care of them,” Ms. Flores says.
Education starts in your practice
Educating patients about the roles of different providers on their health care team starts long before patients enter the exam room, Ms. Flores explains.
Some patients may not understand the difference, some may just forget because they’re used to calling all providers doctors, and others may find it awkward to use a provider’s first name or not know the respectful way to address an NP or a PA.
Practices can help by listing the names and biographies of the health care team on the clinic website. In addition, when patients call for an appointment, Ms. Flores believes front desk staff can reinforce that information. When offering appointments with a physician, NP, or PA, clearly use the practitioner’s title and reiterate it throughout the conversation. For example, “Would you like to see our nurse practitioner, Alice Smith, next week?” or “So, our physician assistant Mrs. Jones will see you Friday at 3 PM.”
The report also found that 76% of patients expressed a preference to see a physician over a PA, and 71% expressed a preference to see a physician over an NP, but offering appointments with nonphysician providers is part of the education process.
“Some families are super savvy and know the differences between nurse practitioners, physician assistants, and doctors, and ... there are families who don’t understand those titles, [and] we need to explain what they do in our practice,” adds Nicole Aaronson, MD, MBA, attending surgeon at Nemours Children’s Health of Delaware. Dr. Aaronson believes there’s an opportunity for educating patients when speaking about all the available providers they may see.
Hanging posters or using brochures in the clinic or hospital is another effective way to reinforce the roles of various providers on the care team. Include biographies and educational information on practice materials and video programs running in the waiting room.
“Patients mean it [calling everyone doctor] as a way to respectfully address the nurse practitioner or physician assistant rather than meaning it as a denigration of the physician,” Dr. Aaronson says. “But everyone appreciates being called by the correct title.”
Helping patients understand the members of their care team and the correct titles to use for those health care professionals could also help patients feel more confident about their health care experience.
“Patients really like knowing that there are specialists in each of the areas taking care of them,” Ms. Flores says. “I think that conveys a feeling of trust in your provider.”
Not everyone is a doctor
Even when PAs and NPs remind patients of their roles and reinforce the use of their preferred names, there will still be patients who continue referring to their nonphysician provider as “doctor.”
“There’s a perception that anyone who walks into a room with a stethoscope is your doctor,” says Graig Straus, DNP, an NP and president and CEO of Rockland Urgent Care Family Health NP, P.C., West Haverstraw, N.Y. “You do get a little bit of burnout correcting people all the time.”
Dr. Straus, who earned his doctorate in nursing practice, notes that patients using the honorific with him aren’t incorrect, but he still educates them on his role within the health care team.
“NPs and PAs have a valuable role to play independently and in concert with the physician,” Dr. Aaronson says. This understanding is essential, as states consider expanding treatment abilities for NPs and PAs.
NPs have expanded treatment abilities or full practice authority in almost half the states, and 31% of the physicians surveyed agreed that NPs should have expanded treatment abilities.
An estimated 1 in 5 states characterizes the physician-PA relationship as collaborative, not supervisory, according to the American Academy of Physician Associates. At the same time, only 39% of physicians surveyed said they favored this trend.
“Patients need great quality care, and there are many different types of providers that can provide that care as part of the team,” Ms. Flores says. “When you have a team taking care of a patient, that patient [gets] the best care possible – and ... that’s why we went into medicine: to deliver high-quality, compassionate care to our patients, and we should all be in this together.”
When practices do their part explaining who is and isn’t a doctor and what each provider’s title and role is and what to call them, and everyone reinforces it, health care becomes not only more manageable for patients to traverse but easier to understand, leading to a better experience.
A version of this article first appeared on Medscape.com.
Size of meals, not timing, linked to weight loss
The number of daily meals, but not the timing between first and last daily meals, was significantly associated with weight changes over a 6-year period, in a prospective study of more than 500 adults.
Some studies suggest that timing food intake – through time-restricted eating or intermittent fasting – can promote weight loss, but these strategies have yielded similar weight loss to eating throughout the day in randomized trials, and population-based studies of meal intervals and weight changes are needed, Di Zhao, PhD, of Johns Hopkins University, Baltimore, and colleagues wrote.
“Obesity is an epidemic,” corresponding author Wendy Bennett, MD, also of Johns Hopkins University, said in an interview. “We are interested in identifying ways to prevent weight gain over time and reduce obesity risk, since telling people to ‘just eat less’ doesn’t always work.”
In a study published in the Journal of the American Heart Association, the researchers recruited 1,017 adults who were patients at one of three health systems; of these, complete data were available for 547 individuals.
The participants downloaded an app called Daily24 to record the timing of their meals and sleep for at least 1 day. The researchers used electronic medical records to obtain information on weight and comorbidities of the participants for up to 10 years before study enrollment through 10 months after enrollment.
The mean age of the participants was 51.1 years, 78% were women, and 78% were White; the mean body mass index was 30.8 kg/m2.
The mean interval from first to last meal was 11.5 hours, and this was not associated with change in weight. The mean times from waking up to the first meal and the time from the last meal to sleeping were 1.6 hours and 4.0 hours, respectively, and these were not associated with weight changes over the follow-up period, the researchers wrote. Sleep duration (mean of 7.5 hours) also was not associated with weight change over time.
However, the total daily number of large and medium-sized meals was associated with weight gain over time, while those who reported more smaller meals showed weight loss. A daily increase of one large, medium, or small meal was associated with an average annual weight change of 0.69 kg, 0.97 kg, and –0.30 kg, respectively.
Benefits of time-restricted eating remain unclear
“Animal studies have shown benefits for time restricted feeding, but there are still questions about whether or not it helps prevent weight gain or promotes weight loss in humans,” Dr. Bennett said in an interview.
As for the current study findings, “we were not surprised; humans are more complicated than animals, and we have complicated behaviors, especially with eating,” she said.
“We showed that windows of eating (eating for longer periods of time or less in a day) was not associated with weight change over time among patients from three health systems,” said Dr. Bennett. “The main implication is that restricting your window of eating, such as eating over less time, or having more fasting time, may not reduce weight gain over time, while eating fewer large meals is associated with less weight gain over time.”
The findings were limited by several factors including the exclusion of many younger and less educated individuals, the short follow-up period, and lack of information on weight loss intention at baseline, the researchers noted. Other limitations included the inability to evaluate time-restricted eating or fasting, and the inclusion of individuals currently seeking care, which may limit generalizability.
However, the results were strengthened by the repeated measures of weight, detailed information on obesity risk factors, and real-time assessment of eating behaviors. The results do not support time-restricted eating as a long-term weight-loss strategy, and more studies are needed with a longer follow-up period, the researchers concluded.
However, there may be a role for time restricted eating as a method of total calorie control, Dr. Bennett said.
“Other studies do show that people might be able to use time-restricted eating or intermittent fasting to help them reduce their caloric intake and thus lose weight, so it can still be a helpful weight loss tool for some people who can adhere to it,” she said.
The study was supported by a grant from the American Heart Association to Johns Hopkins University. Dr. Bennett had no financial conflicts to disclose.
The number of daily meals, but not the timing between first and last daily meals, was significantly associated with weight changes over a 6-year period, in a prospective study of more than 500 adults.
Some studies suggest that timing food intake – through time-restricted eating or intermittent fasting – can promote weight loss, but these strategies have yielded similar weight loss to eating throughout the day in randomized trials, and population-based studies of meal intervals and weight changes are needed, Di Zhao, PhD, of Johns Hopkins University, Baltimore, and colleagues wrote.
“Obesity is an epidemic,” corresponding author Wendy Bennett, MD, also of Johns Hopkins University, said in an interview. “We are interested in identifying ways to prevent weight gain over time and reduce obesity risk, since telling people to ‘just eat less’ doesn’t always work.”
In a study published in the Journal of the American Heart Association, the researchers recruited 1,017 adults who were patients at one of three health systems; of these, complete data were available for 547 individuals.
The participants downloaded an app called Daily24 to record the timing of their meals and sleep for at least 1 day. The researchers used electronic medical records to obtain information on weight and comorbidities of the participants for up to 10 years before study enrollment through 10 months after enrollment.
The mean age of the participants was 51.1 years, 78% were women, and 78% were White; the mean body mass index was 30.8 kg/m2.
The mean interval from first to last meal was 11.5 hours, and this was not associated with change in weight. The mean times from waking up to the first meal and the time from the last meal to sleeping were 1.6 hours and 4.0 hours, respectively, and these were not associated with weight changes over the follow-up period, the researchers wrote. Sleep duration (mean of 7.5 hours) also was not associated with weight change over time.
However, the total daily number of large and medium-sized meals was associated with weight gain over time, while those who reported more smaller meals showed weight loss. A daily increase of one large, medium, or small meal was associated with an average annual weight change of 0.69 kg, 0.97 kg, and –0.30 kg, respectively.
Benefits of time-restricted eating remain unclear
“Animal studies have shown benefits for time restricted feeding, but there are still questions about whether or not it helps prevent weight gain or promotes weight loss in humans,” Dr. Bennett said in an interview.
As for the current study findings, “we were not surprised; humans are more complicated than animals, and we have complicated behaviors, especially with eating,” she said.
“We showed that windows of eating (eating for longer periods of time or less in a day) was not associated with weight change over time among patients from three health systems,” said Dr. Bennett. “The main implication is that restricting your window of eating, such as eating over less time, or having more fasting time, may not reduce weight gain over time, while eating fewer large meals is associated with less weight gain over time.”
The findings were limited by several factors including the exclusion of many younger and less educated individuals, the short follow-up period, and lack of information on weight loss intention at baseline, the researchers noted. Other limitations included the inability to evaluate time-restricted eating or fasting, and the inclusion of individuals currently seeking care, which may limit generalizability.
However, the results were strengthened by the repeated measures of weight, detailed information on obesity risk factors, and real-time assessment of eating behaviors. The results do not support time-restricted eating as a long-term weight-loss strategy, and more studies are needed with a longer follow-up period, the researchers concluded.
However, there may be a role for time restricted eating as a method of total calorie control, Dr. Bennett said.
“Other studies do show that people might be able to use time-restricted eating or intermittent fasting to help them reduce their caloric intake and thus lose weight, so it can still be a helpful weight loss tool for some people who can adhere to it,” she said.
The study was supported by a grant from the American Heart Association to Johns Hopkins University. Dr. Bennett had no financial conflicts to disclose.
The number of daily meals, but not the timing between first and last daily meals, was significantly associated with weight changes over a 6-year period, in a prospective study of more than 500 adults.
Some studies suggest that timing food intake – through time-restricted eating or intermittent fasting – can promote weight loss, but these strategies have yielded similar weight loss to eating throughout the day in randomized trials, and population-based studies of meal intervals and weight changes are needed, Di Zhao, PhD, of Johns Hopkins University, Baltimore, and colleagues wrote.
“Obesity is an epidemic,” corresponding author Wendy Bennett, MD, also of Johns Hopkins University, said in an interview. “We are interested in identifying ways to prevent weight gain over time and reduce obesity risk, since telling people to ‘just eat less’ doesn’t always work.”
In a study published in the Journal of the American Heart Association, the researchers recruited 1,017 adults who were patients at one of three health systems; of these, complete data were available for 547 individuals.
The participants downloaded an app called Daily24 to record the timing of their meals and sleep for at least 1 day. The researchers used electronic medical records to obtain information on weight and comorbidities of the participants for up to 10 years before study enrollment through 10 months after enrollment.
The mean age of the participants was 51.1 years, 78% were women, and 78% were White; the mean body mass index was 30.8 kg/m2.
The mean interval from first to last meal was 11.5 hours, and this was not associated with change in weight. The mean times from waking up to the first meal and the time from the last meal to sleeping were 1.6 hours and 4.0 hours, respectively, and these were not associated with weight changes over the follow-up period, the researchers wrote. Sleep duration (mean of 7.5 hours) also was not associated with weight change over time.
However, the total daily number of large and medium-sized meals was associated with weight gain over time, while those who reported more smaller meals showed weight loss. A daily increase of one large, medium, or small meal was associated with an average annual weight change of 0.69 kg, 0.97 kg, and –0.30 kg, respectively.
Benefits of time-restricted eating remain unclear
“Animal studies have shown benefits for time restricted feeding, but there are still questions about whether or not it helps prevent weight gain or promotes weight loss in humans,” Dr. Bennett said in an interview.
As for the current study findings, “we were not surprised; humans are more complicated than animals, and we have complicated behaviors, especially with eating,” she said.
“We showed that windows of eating (eating for longer periods of time or less in a day) was not associated with weight change over time among patients from three health systems,” said Dr. Bennett. “The main implication is that restricting your window of eating, such as eating over less time, or having more fasting time, may not reduce weight gain over time, while eating fewer large meals is associated with less weight gain over time.”
The findings were limited by several factors including the exclusion of many younger and less educated individuals, the short follow-up period, and lack of information on weight loss intention at baseline, the researchers noted. Other limitations included the inability to evaluate time-restricted eating or fasting, and the inclusion of individuals currently seeking care, which may limit generalizability.
However, the results were strengthened by the repeated measures of weight, detailed information on obesity risk factors, and real-time assessment of eating behaviors. The results do not support time-restricted eating as a long-term weight-loss strategy, and more studies are needed with a longer follow-up period, the researchers concluded.
However, there may be a role for time restricted eating as a method of total calorie control, Dr. Bennett said.
“Other studies do show that people might be able to use time-restricted eating or intermittent fasting to help them reduce their caloric intake and thus lose weight, so it can still be a helpful weight loss tool for some people who can adhere to it,” she said.
The study was supported by a grant from the American Heart Association to Johns Hopkins University. Dr. Bennett had no financial conflicts to disclose.
FROM THE JOURNAL OF THE AMERICAN HEART ASSOCIATION
Emotional eating tied to risk of diastolic dysfunction
Eating in response to stress – known as emotional eating – was significantly associated with several markers of long-term cardiovascular damage, based on data from 1,109 individuals.
“We know diet plays a huge role in cardiovascular disease, but we have focused a lot of work on what you eat, not on what makes you eat” – the current study did exactly that, Martha Gulati, MD, who wasn’t involved in the study, said in an interview.
“Emotional eaters consume food to satisfy their brains rather than their stomachs,” study investigator Nicolas Girerd, MD, of the National Institute of Health and Medical Research (INSERM) and a cardiologist at the University Hospital of Nancy (France), wrote in a press release accompanying the study.
Diet plays a role in the development of cardiovascular disease (CVD), but the impact of eating behavior on long-term cardiovascular health remains unclear, wrote Dr. Girerd and colleagues. Previous research has yielded three common psychological dimensions for eating behavior: emotional eating, restrained eating, and external eating.
Both emotional eating and restrained eating have been linked to cardiovascular disease risk, the researchers noted. “Because of previous findings, we hypothesized that [emotional and/or restrained dimensions of eating behavior] are positively associated with cardiovascular damages, as well as with CV risk factors, such as metabolic syndrome,” they wrote.
In a study published in the European Journal of Preventive Cardiology, the researchers reviewed data from 916 adults and 193 adolescents who were participants in the STANISLAS (Suivi Temporaire Annuel Non-Invasif de la Santé des Lorrains Assurés Sociaux), a longitudinal familial cohort in France. Cardiovascular data were collected at four medical visits as part of a full clinical examination between 1993 and 2016, with one visit every 5-10 years. Roughly one-third (31.0%) of the adults were overweight, 7.9% were obese, and 2.7% were underweight. The median age of the adults at the second visit was 44.7 years; the median age of the adolescent group was 15.2 years.
The primary outcome of cardiovascular damage was measured at the fourth visit. Eating behavior was assessed during the second visit using the Dutch Eating Behaviour Questionnaire (DEBQ), and participants were identified as emotional eaters, restrained eaters, or external eaters.
Among the adults, emotional eating was associated with a 38% increased risk of diastolic dysfunction (odds ratio, 1.38; P = .02), over an average follow-up of 13 years, and this association was mediated by stress in 32% of cases. Emotional eating also was positively linked with a higher carotid-femoral pulse-wave velocity (cfPWV-beta), indicative of increased arterial stiffness. However, none of the three dimensions of eating behavior was associated with cardiovascular damage among the adolescents. In addition, none of the eating-behavior dimensions was tied to metabolic syndrome in the adult group (this association was not measured in the adolescents).
Energy intake had no apparent impact on any associations between eating behavior and CVD measures, Dr. Girerd said in the press release. “We might expect that emotional eaters would consume high-calorie foods, which would in turn lead to cardiovascular problems, but this was not the case. One explanation is that we measured average calorie intake and emotional eaters may binge when stressed and then eat less at other times,” and that the resulting “yo-yo” pattern might negatively affect the heart and blood vessels more than stable food intake, he said.
The study findings were limited by several factors, including the observational design that prevented conclusions of causality, the researchers noted. Other limitations included the use of a nonvalidated scale to measure stress, the lack of data on physical activity, and the use of a mainly healthy population in a limited geographic area, which may limit generalizability, they said.
More research is needed in other contexts and larger cohorts, but the results were strengthened by the large study population and the complete data on eating behaviors and detailed health information, they wrote. The results support previous studies and suggest that patients with emotional eating behavior could benefit from emotion regulation skills training, including cognitive, behavioral, psychological, and interpersonal therapies used in other areas, and from pharmacological treatments, the researchers concluded.
The current study offers a unique and important perspective on the relationship between diet and cardiovascular disease, Dr. Gulati, director of preventive cardiology at the Smidt Heart Institute at Cedars-Sinai Medical Center, Los Angeles, told this news organization.
“Examining eating behavior and its relationship with cardiovascular effects in healthy individuals in this prospective way is quite interesting,” said Dr. Gulati, who was not involved in the study.
The researchers examined healthy people at baseline, inquired about their eating habits, and found that emotional eaters “have evidence of cardiovascular changes when compared with the other groups of eaters, after controlling for other risk factors that are associated with cardiovascular disease when following them for 13 years,” said Dr. Gulati, who was recently named Anita Dann Friedman Endowed Chair in Women’s Cardiovascular Medicine and Research at Cedars-Sinai. “This same finding wasn’t seen in adolescents, but this is probably because they are younger, and the effects aren’t seen. That is reassuring, because it means that the more we address eating behaviors, the more likely we are to reduce their effects to the heart,” she noted.
“This study is important because usually, as cardiologists or anyone in medicine, how we assess diet is by assessment of what food people eat; we don’t usually ask about what triggers them to eat,” Dr. Gulati said. “Eating behaviors based on their triggers ultimately affect food choice and food quantity, and help us understand weight changes during a lifetime,” she said.
“I think we don’t have the data to know that an eating behavior would be able to affect cardiac function,” said Dr. Gulati, “but I think we all might hypothesize that emotional eating may be associated with abnormal diastolic function simply through eating high-density food and weight gain.”
The current study did not show a relationship between eating behavior and metabolic syndrome, in contrast with prior studies, Dr. Gulati noted. However, “the authors report that the association between eating behaviors and diastolic dysfunction was mediated through the stress level,” Dr. Gulati said. “It is important to note that this European population was healthy at baseline, and also relatively healthy 13 years later, which makes these findings even more profound.”
Dr. Gulati said that she agrees with the study authors on the need to assess diet and eating behaviors when assessing cardiovascular risk in patient. “Diet assessment as part of prevention is central, but we should ask not only ‘what do you eat,’ but also ‘what makes you eat,’ ” she said.
More research is needed in other populations, Dr. Gulati added. The current study population was healthy at baseline and follow-up. Studies are needed in cohorts in the United States and in the developing world to see how the results might differ; as well as in rural America or in “food deserts” where food choices are limited.
Another research topic is the interplay between eating behaviors and social determinants of health, in terms of their effect on cardiovascular function, Dr. Gulati said, “and it will be valuable to follow this cohort further to see how these eating behaviors and these intermediate measures translate into cardiovascular outcomes.” Future studies should also examine whether the changes in cardiac function are reversible by interventions to modify eating behavior, particularly emotional eating, she said.
Supporters of the study included the Regional University Hospital Center of Nancy, the French Ministry of Solidarity and Health, and a public grant overseen by the French National Research Agency. The researchers had no financial conflicts to disclose.
Dr. Gulati, who serves on the editorial advisory board of MDedge Cardiology, had no financial conflicts to disclose.
Eating in response to stress – known as emotional eating – was significantly associated with several markers of long-term cardiovascular damage, based on data from 1,109 individuals.
“We know diet plays a huge role in cardiovascular disease, but we have focused a lot of work on what you eat, not on what makes you eat” – the current study did exactly that, Martha Gulati, MD, who wasn’t involved in the study, said in an interview.
“Emotional eaters consume food to satisfy their brains rather than their stomachs,” study investigator Nicolas Girerd, MD, of the National Institute of Health and Medical Research (INSERM) and a cardiologist at the University Hospital of Nancy (France), wrote in a press release accompanying the study.
Diet plays a role in the development of cardiovascular disease (CVD), but the impact of eating behavior on long-term cardiovascular health remains unclear, wrote Dr. Girerd and colleagues. Previous research has yielded three common psychological dimensions for eating behavior: emotional eating, restrained eating, and external eating.
Both emotional eating and restrained eating have been linked to cardiovascular disease risk, the researchers noted. “Because of previous findings, we hypothesized that [emotional and/or restrained dimensions of eating behavior] are positively associated with cardiovascular damages, as well as with CV risk factors, such as metabolic syndrome,” they wrote.
In a study published in the European Journal of Preventive Cardiology, the researchers reviewed data from 916 adults and 193 adolescents who were participants in the STANISLAS (Suivi Temporaire Annuel Non-Invasif de la Santé des Lorrains Assurés Sociaux), a longitudinal familial cohort in France. Cardiovascular data were collected at four medical visits as part of a full clinical examination between 1993 and 2016, with one visit every 5-10 years. Roughly one-third (31.0%) of the adults were overweight, 7.9% were obese, and 2.7% were underweight. The median age of the adults at the second visit was 44.7 years; the median age of the adolescent group was 15.2 years.
The primary outcome of cardiovascular damage was measured at the fourth visit. Eating behavior was assessed during the second visit using the Dutch Eating Behaviour Questionnaire (DEBQ), and participants were identified as emotional eaters, restrained eaters, or external eaters.
Among the adults, emotional eating was associated with a 38% increased risk of diastolic dysfunction (odds ratio, 1.38; P = .02), over an average follow-up of 13 years, and this association was mediated by stress in 32% of cases. Emotional eating also was positively linked with a higher carotid-femoral pulse-wave velocity (cfPWV-beta), indicative of increased arterial stiffness. However, none of the three dimensions of eating behavior was associated with cardiovascular damage among the adolescents. In addition, none of the eating-behavior dimensions was tied to metabolic syndrome in the adult group (this association was not measured in the adolescents).
Energy intake had no apparent impact on any associations between eating behavior and CVD measures, Dr. Girerd said in the press release. “We might expect that emotional eaters would consume high-calorie foods, which would in turn lead to cardiovascular problems, but this was not the case. One explanation is that we measured average calorie intake and emotional eaters may binge when stressed and then eat less at other times,” and that the resulting “yo-yo” pattern might negatively affect the heart and blood vessels more than stable food intake, he said.
The study findings were limited by several factors, including the observational design that prevented conclusions of causality, the researchers noted. Other limitations included the use of a nonvalidated scale to measure stress, the lack of data on physical activity, and the use of a mainly healthy population in a limited geographic area, which may limit generalizability, they said.
More research is needed in other contexts and larger cohorts, but the results were strengthened by the large study population and the complete data on eating behaviors and detailed health information, they wrote. The results support previous studies and suggest that patients with emotional eating behavior could benefit from emotion regulation skills training, including cognitive, behavioral, psychological, and interpersonal therapies used in other areas, and from pharmacological treatments, the researchers concluded.
The current study offers a unique and important perspective on the relationship between diet and cardiovascular disease, Dr. Gulati, director of preventive cardiology at the Smidt Heart Institute at Cedars-Sinai Medical Center, Los Angeles, told this news organization.
“Examining eating behavior and its relationship with cardiovascular effects in healthy individuals in this prospective way is quite interesting,” said Dr. Gulati, who was not involved in the study.
The researchers examined healthy people at baseline, inquired about their eating habits, and found that emotional eaters “have evidence of cardiovascular changes when compared with the other groups of eaters, after controlling for other risk factors that are associated with cardiovascular disease when following them for 13 years,” said Dr. Gulati, who was recently named Anita Dann Friedman Endowed Chair in Women’s Cardiovascular Medicine and Research at Cedars-Sinai. “This same finding wasn’t seen in adolescents, but this is probably because they are younger, and the effects aren’t seen. That is reassuring, because it means that the more we address eating behaviors, the more likely we are to reduce their effects to the heart,” she noted.
“This study is important because usually, as cardiologists or anyone in medicine, how we assess diet is by assessment of what food people eat; we don’t usually ask about what triggers them to eat,” Dr. Gulati said. “Eating behaviors based on their triggers ultimately affect food choice and food quantity, and help us understand weight changes during a lifetime,” she said.
“I think we don’t have the data to know that an eating behavior would be able to affect cardiac function,” said Dr. Gulati, “but I think we all might hypothesize that emotional eating may be associated with abnormal diastolic function simply through eating high-density food and weight gain.”
The current study did not show a relationship between eating behavior and metabolic syndrome, in contrast with prior studies, Dr. Gulati noted. However, “the authors report that the association between eating behaviors and diastolic dysfunction was mediated through the stress level,” Dr. Gulati said. “It is important to note that this European population was healthy at baseline, and also relatively healthy 13 years later, which makes these findings even more profound.”
Dr. Gulati said that she agrees with the study authors on the need to assess diet and eating behaviors when assessing cardiovascular risk in patient. “Diet assessment as part of prevention is central, but we should ask not only ‘what do you eat,’ but also ‘what makes you eat,’ ” she said.
More research is needed in other populations, Dr. Gulati added. The current study population was healthy at baseline and follow-up. Studies are needed in cohorts in the United States and in the developing world to see how the results might differ; as well as in rural America or in “food deserts” where food choices are limited.
Another research topic is the interplay between eating behaviors and social determinants of health, in terms of their effect on cardiovascular function, Dr. Gulati said, “and it will be valuable to follow this cohort further to see how these eating behaviors and these intermediate measures translate into cardiovascular outcomes.” Future studies should also examine whether the changes in cardiac function are reversible by interventions to modify eating behavior, particularly emotional eating, she said.
Supporters of the study included the Regional University Hospital Center of Nancy, the French Ministry of Solidarity and Health, and a public grant overseen by the French National Research Agency. The researchers had no financial conflicts to disclose.
Dr. Gulati, who serves on the editorial advisory board of MDedge Cardiology, had no financial conflicts to disclose.
Eating in response to stress – known as emotional eating – was significantly associated with several markers of long-term cardiovascular damage, based on data from 1,109 individuals.
“We know diet plays a huge role in cardiovascular disease, but we have focused a lot of work on what you eat, not on what makes you eat” – the current study did exactly that, Martha Gulati, MD, who wasn’t involved in the study, said in an interview.
“Emotional eaters consume food to satisfy their brains rather than their stomachs,” study investigator Nicolas Girerd, MD, of the National Institute of Health and Medical Research (INSERM) and a cardiologist at the University Hospital of Nancy (France), wrote in a press release accompanying the study.
Diet plays a role in the development of cardiovascular disease (CVD), but the impact of eating behavior on long-term cardiovascular health remains unclear, wrote Dr. Girerd and colleagues. Previous research has yielded three common psychological dimensions for eating behavior: emotional eating, restrained eating, and external eating.
Both emotional eating and restrained eating have been linked to cardiovascular disease risk, the researchers noted. “Because of previous findings, we hypothesized that [emotional and/or restrained dimensions of eating behavior] are positively associated with cardiovascular damages, as well as with CV risk factors, such as metabolic syndrome,” they wrote.
In a study published in the European Journal of Preventive Cardiology, the researchers reviewed data from 916 adults and 193 adolescents who were participants in the STANISLAS (Suivi Temporaire Annuel Non-Invasif de la Santé des Lorrains Assurés Sociaux), a longitudinal familial cohort in France. Cardiovascular data were collected at four medical visits as part of a full clinical examination between 1993 and 2016, with one visit every 5-10 years. Roughly one-third (31.0%) of the adults were overweight, 7.9% were obese, and 2.7% were underweight. The median age of the adults at the second visit was 44.7 years; the median age of the adolescent group was 15.2 years.
The primary outcome of cardiovascular damage was measured at the fourth visit. Eating behavior was assessed during the second visit using the Dutch Eating Behaviour Questionnaire (DEBQ), and participants were identified as emotional eaters, restrained eaters, or external eaters.
Among the adults, emotional eating was associated with a 38% increased risk of diastolic dysfunction (odds ratio, 1.38; P = .02), over an average follow-up of 13 years, and this association was mediated by stress in 32% of cases. Emotional eating also was positively linked with a higher carotid-femoral pulse-wave velocity (cfPWV-beta), indicative of increased arterial stiffness. However, none of the three dimensions of eating behavior was associated with cardiovascular damage among the adolescents. In addition, none of the eating-behavior dimensions was tied to metabolic syndrome in the adult group (this association was not measured in the adolescents).
Energy intake had no apparent impact on any associations between eating behavior and CVD measures, Dr. Girerd said in the press release. “We might expect that emotional eaters would consume high-calorie foods, which would in turn lead to cardiovascular problems, but this was not the case. One explanation is that we measured average calorie intake and emotional eaters may binge when stressed and then eat less at other times,” and that the resulting “yo-yo” pattern might negatively affect the heart and blood vessels more than stable food intake, he said.
The study findings were limited by several factors, including the observational design that prevented conclusions of causality, the researchers noted. Other limitations included the use of a nonvalidated scale to measure stress, the lack of data on physical activity, and the use of a mainly healthy population in a limited geographic area, which may limit generalizability, they said.
More research is needed in other contexts and larger cohorts, but the results were strengthened by the large study population and the complete data on eating behaviors and detailed health information, they wrote. The results support previous studies and suggest that patients with emotional eating behavior could benefit from emotion regulation skills training, including cognitive, behavioral, psychological, and interpersonal therapies used in other areas, and from pharmacological treatments, the researchers concluded.
The current study offers a unique and important perspective on the relationship between diet and cardiovascular disease, Dr. Gulati, director of preventive cardiology at the Smidt Heart Institute at Cedars-Sinai Medical Center, Los Angeles, told this news organization.
“Examining eating behavior and its relationship with cardiovascular effects in healthy individuals in this prospective way is quite interesting,” said Dr. Gulati, who was not involved in the study.
The researchers examined healthy people at baseline, inquired about their eating habits, and found that emotional eaters “have evidence of cardiovascular changes when compared with the other groups of eaters, after controlling for other risk factors that are associated with cardiovascular disease when following them for 13 years,” said Dr. Gulati, who was recently named Anita Dann Friedman Endowed Chair in Women’s Cardiovascular Medicine and Research at Cedars-Sinai. “This same finding wasn’t seen in adolescents, but this is probably because they are younger, and the effects aren’t seen. That is reassuring, because it means that the more we address eating behaviors, the more likely we are to reduce their effects to the heart,” she noted.
“This study is important because usually, as cardiologists or anyone in medicine, how we assess diet is by assessment of what food people eat; we don’t usually ask about what triggers them to eat,” Dr. Gulati said. “Eating behaviors based on their triggers ultimately affect food choice and food quantity, and help us understand weight changes during a lifetime,” she said.
“I think we don’t have the data to know that an eating behavior would be able to affect cardiac function,” said Dr. Gulati, “but I think we all might hypothesize that emotional eating may be associated with abnormal diastolic function simply through eating high-density food and weight gain.”
The current study did not show a relationship between eating behavior and metabolic syndrome, in contrast with prior studies, Dr. Gulati noted. However, “the authors report that the association between eating behaviors and diastolic dysfunction was mediated through the stress level,” Dr. Gulati said. “It is important to note that this European population was healthy at baseline, and also relatively healthy 13 years later, which makes these findings even more profound.”
Dr. Gulati said that she agrees with the study authors on the need to assess diet and eating behaviors when assessing cardiovascular risk in patient. “Diet assessment as part of prevention is central, but we should ask not only ‘what do you eat,’ but also ‘what makes you eat,’ ” she said.
More research is needed in other populations, Dr. Gulati added. The current study population was healthy at baseline and follow-up. Studies are needed in cohorts in the United States and in the developing world to see how the results might differ; as well as in rural America or in “food deserts” where food choices are limited.
Another research topic is the interplay between eating behaviors and social determinants of health, in terms of their effect on cardiovascular function, Dr. Gulati said, “and it will be valuable to follow this cohort further to see how these eating behaviors and these intermediate measures translate into cardiovascular outcomes.” Future studies should also examine whether the changes in cardiac function are reversible by interventions to modify eating behavior, particularly emotional eating, she said.
Supporters of the study included the Regional University Hospital Center of Nancy, the French Ministry of Solidarity and Health, and a public grant overseen by the French National Research Agency. The researchers had no financial conflicts to disclose.
Dr. Gulati, who serves on the editorial advisory board of MDedge Cardiology, had no financial conflicts to disclose.
FROM THE EUROPEAN JOURNAL OF PREVENTIVE CARDIOLOGY
Physician sues AMA for defamation over 2022 election controversy
If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.
The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.
“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.
The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.
Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.
As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
‘Quid pro quo’ alleged
In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.
According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.
Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.
The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”
On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.
Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.
Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.
Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.
The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.
Dr. Edwards was given a short opportunity to speak, in which she denied any violations.
According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”
The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”
Dr. Edwards lost the election.
AMA: Nothing more to add
The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.
In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”
The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.
The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”
He added that there “is no official transcript of the Speaker’s report.”
A version of this article first appeared on Medscape.com.
If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.
The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.
“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.
The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.
Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.
As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
‘Quid pro quo’ alleged
In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.
According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.
Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.
The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”
On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.
Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.
Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.
Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.
The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.
Dr. Edwards was given a short opportunity to speak, in which she denied any violations.
According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”
The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”
Dr. Edwards lost the election.
AMA: Nothing more to add
The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.
In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”
The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.
The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”
He added that there “is no official transcript of the Speaker’s report.”
A version of this article first appeared on Medscape.com.
If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.
The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.
“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.
The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.
Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.
As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
‘Quid pro quo’ alleged
In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.
According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.
Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.
The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”
On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.
Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.
Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.
Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.
The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.
Dr. Edwards was given a short opportunity to speak, in which she denied any violations.
According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”
The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”
Dr. Edwards lost the election.
AMA: Nothing more to add
The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.
In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”
The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.
The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”
He added that there “is no official transcript of the Speaker’s report.”
A version of this article first appeared on Medscape.com.
Will your smartphone be the next doctor’s office?
A fingertip pressed against a phone’s camera lens can measure a heart rate. The microphone, kept by the bedside, can screen for sleep apnea. Even the speaker is being tapped, to monitor breathing using sonar technology.
In the best of this new world, the data is conveyed remotely to a medical professional for the convenience and comfort of the patient or, in some cases, to support a clinician without the need for costly hardware.
But using smartphones as diagnostic tools is a work in progress, experts say. Although doctors and their patients have found some real-world success in deploying the phone as a medical device, the overall potential remains unfulfilled and uncertain.
Smartphones come packed with sensors capable of monitoring a patient’s vital signs. They can help assess people for concussions, watch for atrial fibrillation, and conduct mental health wellness checks, to name the uses of a few nascent applications.
Companies and researchers eager to find medical applications for smartphone technology are tapping into modern phones’ built-in cameras and light sensors; microphones; accelerometers, which detect body movements; gyroscopes; and even speakers. The apps then use artificial intelligence software to analyze the collected sights and sounds to create an easy connection between patients and physicians. Earning potential and marketability are evidenced by the more than 350,000 digital health products available in app stores, according to a Grand View Research report.
“It’s very hard to put devices into the patient home or in the hospital, but everybody is just walking around with a cellphone that has a network connection,” said Dr. Andrew Gostine, CEO of the sensor network company Artisight. Most Americans own a smartphone, including more than 60% of people 65 and over, an increase from just 13% a decade ago, according the Pew Research Center. The COVID-19 pandemic has also pushed people to become more comfortable with virtual care.
Some of these products have sought FDA clearance to be marketed as a medical device. That way, if patients must pay to use the software, health insurers are more likely to cover at least part of the cost. Other products are designated as exempt from this regulatory process, placed in the same clinical classification as a Band-Aid. But how the agency handles AI and machine learning–based medical devices is still being adjusted to reflect software’s adaptive nature.
Ensuring accuracy and clinical validation is crucial to securing buy-in from health care providers. And many tools still need fine-tuning, said Eugene Yang, MD, a professor of medicine at the University of Washington, Seattle. Currently, Dr. Yang is testing contactless measurement of blood pressure, heart rate, and oxygen saturation gleaned remotely via Zoom camera footage of a patient’s face.
Judging these new technologies is difficult because they rely on algorithms built by machine learning and artificial intelligence to collect data, rather than the physical tools typically used in hospitals. So researchers cannot “compare apples to apples” with medical industry standards, Dr. Yang said. Failure to build in such assurances undermines the technology’s ultimate goals of easing costs and access because a doctor still must verify results.
“False positives and false negatives lead to more testing and more cost to the health care system,” he said.
Big tech companies like Google have heavily invested in researching this kind of technology, catering to clinicians and in-home caregivers, as well as consumers. Currently, in the Google Fit app, users can check their heart rate by placing their finger on the rear-facing camera lens or track their breathing rate using the front-facing camera.
“If you took the sensor out of the phone and out of a clinical device, they are probably the same thing,” said Shwetak Patel, director of health technologies at Google and a professor of electrical and computer engineering at the University of Washington.
Google’s research uses machine learning and computer vision, a field within AI based on information from visual inputs like videos or images. So instead of using a blood pressure cuff, for example, the algorithm can interpret slight visual changes to the body that serve as proxies and biosignals for a patient’s blood pressure, Mr. Patel said.
Google is also investigating the effectiveness of the built-in microphone for detecting heartbeats and murmurs and using the camera to preserve eyesight by screening for diabetic eye disease, according to information the company published last year.
The tech giant recently purchased Sound Life Sciences, a Seattle startup with an FDA-cleared sonar technology app. It uses a smart device’s speaker to bounce inaudible pulses off a patient’s body to identify movement and monitor breathing.
Binah.ai, based in Israel, is another company using the smartphone camera to calculate vital signs. Its software looks at the region around the eyes, where the skin is a bit thinner, and analyzes the light reflecting off blood vessels back to the lens. The company is wrapping up a U.S. clinical trial and marketing its wellness app directly to insurers and other health companies, said company spokesperson Mona Popilian-Yona.
The applications even reach into disciplines such as optometry and mental health:
- With the microphone, Canary Speech uses the same underlying technology as Amazon’s Alexa to analyze patients’ voices for mental health conditions. The software can integrate with telemedicine appointments and allow clinicians to screen for anxiety and depression using a library of vocal biomarkers and predictive analytics, said Henry O’Connell, the company’s CEO.
- Australia-based ResApp Health last year for its iPhone app that screens for moderate to severe obstructive sleep apnea by listening to breathing and snoring. SleepCheckRx, which will require a prescription, is minimally invasive compared with sleep studies currently used to diagnose sleep apnea. Those can cost thousands of dollars and require an array of tests.
- Brightlamp’s Reflex app is a clinical decision support tool for helping manage concussions and vision rehabilitation, among other things. Using an iPad’s or iPhone’s camera, the mobile app measures how a person’s pupils react to changes in light. Through machine learning analysis, the imagery gives practitioners data points for evaluating patients. Brightlamp sells directly to health care providers and is being used in more than 230 clinics. Clinicians pay a $400 standard annual fee per account, which is currently not covered by insurance. The Department of Defense has an ongoing clinical trial using Reflex.
In some cases, such as with the Reflex app, the data is processed directly on the phone – rather than in the cloud, Brightlamp CEO Kurtis Sluss said. By processing everything on the device, the app avoids running into privacy issues, as streaming data elsewhere requires patient consent.
But algorithms need to be trained and tested by collecting reams of data, and that is an ongoing process.
Researchers, for example, have found that some computer vision applications, like heart rate or blood pressure monitoring, can be less accurate for darker skin. Studies are underway to find better solutions.
Small algorithm glitches can also produce false alarms and frighten patients enough to keep widespread adoption out of reach. For example, Apple’s new car-crash detection feature, available on both the latest iPhone and Apple Watch, was set off when people were riding roller coasters and automatically dialed 911.
“We’re not there yet,” Dr. Yang said. “That’s the bottom line.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
A fingertip pressed against a phone’s camera lens can measure a heart rate. The microphone, kept by the bedside, can screen for sleep apnea. Even the speaker is being tapped, to monitor breathing using sonar technology.
In the best of this new world, the data is conveyed remotely to a medical professional for the convenience and comfort of the patient or, in some cases, to support a clinician without the need for costly hardware.
But using smartphones as diagnostic tools is a work in progress, experts say. Although doctors and their patients have found some real-world success in deploying the phone as a medical device, the overall potential remains unfulfilled and uncertain.
Smartphones come packed with sensors capable of monitoring a patient’s vital signs. They can help assess people for concussions, watch for atrial fibrillation, and conduct mental health wellness checks, to name the uses of a few nascent applications.
Companies and researchers eager to find medical applications for smartphone technology are tapping into modern phones’ built-in cameras and light sensors; microphones; accelerometers, which detect body movements; gyroscopes; and even speakers. The apps then use artificial intelligence software to analyze the collected sights and sounds to create an easy connection between patients and physicians. Earning potential and marketability are evidenced by the more than 350,000 digital health products available in app stores, according to a Grand View Research report.
“It’s very hard to put devices into the patient home or in the hospital, but everybody is just walking around with a cellphone that has a network connection,” said Dr. Andrew Gostine, CEO of the sensor network company Artisight. Most Americans own a smartphone, including more than 60% of people 65 and over, an increase from just 13% a decade ago, according the Pew Research Center. The COVID-19 pandemic has also pushed people to become more comfortable with virtual care.
Some of these products have sought FDA clearance to be marketed as a medical device. That way, if patients must pay to use the software, health insurers are more likely to cover at least part of the cost. Other products are designated as exempt from this regulatory process, placed in the same clinical classification as a Band-Aid. But how the agency handles AI and machine learning–based medical devices is still being adjusted to reflect software’s adaptive nature.
Ensuring accuracy and clinical validation is crucial to securing buy-in from health care providers. And many tools still need fine-tuning, said Eugene Yang, MD, a professor of medicine at the University of Washington, Seattle. Currently, Dr. Yang is testing contactless measurement of blood pressure, heart rate, and oxygen saturation gleaned remotely via Zoom camera footage of a patient’s face.
Judging these new technologies is difficult because they rely on algorithms built by machine learning and artificial intelligence to collect data, rather than the physical tools typically used in hospitals. So researchers cannot “compare apples to apples” with medical industry standards, Dr. Yang said. Failure to build in such assurances undermines the technology’s ultimate goals of easing costs and access because a doctor still must verify results.
“False positives and false negatives lead to more testing and more cost to the health care system,” he said.
Big tech companies like Google have heavily invested in researching this kind of technology, catering to clinicians and in-home caregivers, as well as consumers. Currently, in the Google Fit app, users can check their heart rate by placing their finger on the rear-facing camera lens or track their breathing rate using the front-facing camera.
“If you took the sensor out of the phone and out of a clinical device, they are probably the same thing,” said Shwetak Patel, director of health technologies at Google and a professor of electrical and computer engineering at the University of Washington.
Google’s research uses machine learning and computer vision, a field within AI based on information from visual inputs like videos or images. So instead of using a blood pressure cuff, for example, the algorithm can interpret slight visual changes to the body that serve as proxies and biosignals for a patient’s blood pressure, Mr. Patel said.
Google is also investigating the effectiveness of the built-in microphone for detecting heartbeats and murmurs and using the camera to preserve eyesight by screening for diabetic eye disease, according to information the company published last year.
The tech giant recently purchased Sound Life Sciences, a Seattle startup with an FDA-cleared sonar technology app. It uses a smart device’s speaker to bounce inaudible pulses off a patient’s body to identify movement and monitor breathing.
Binah.ai, based in Israel, is another company using the smartphone camera to calculate vital signs. Its software looks at the region around the eyes, where the skin is a bit thinner, and analyzes the light reflecting off blood vessels back to the lens. The company is wrapping up a U.S. clinical trial and marketing its wellness app directly to insurers and other health companies, said company spokesperson Mona Popilian-Yona.
The applications even reach into disciplines such as optometry and mental health:
- With the microphone, Canary Speech uses the same underlying technology as Amazon’s Alexa to analyze patients’ voices for mental health conditions. The software can integrate with telemedicine appointments and allow clinicians to screen for anxiety and depression using a library of vocal biomarkers and predictive analytics, said Henry O’Connell, the company’s CEO.
- Australia-based ResApp Health last year for its iPhone app that screens for moderate to severe obstructive sleep apnea by listening to breathing and snoring. SleepCheckRx, which will require a prescription, is minimally invasive compared with sleep studies currently used to diagnose sleep apnea. Those can cost thousands of dollars and require an array of tests.
- Brightlamp’s Reflex app is a clinical decision support tool for helping manage concussions and vision rehabilitation, among other things. Using an iPad’s or iPhone’s camera, the mobile app measures how a person’s pupils react to changes in light. Through machine learning analysis, the imagery gives practitioners data points for evaluating patients. Brightlamp sells directly to health care providers and is being used in more than 230 clinics. Clinicians pay a $400 standard annual fee per account, which is currently not covered by insurance. The Department of Defense has an ongoing clinical trial using Reflex.
In some cases, such as with the Reflex app, the data is processed directly on the phone – rather than in the cloud, Brightlamp CEO Kurtis Sluss said. By processing everything on the device, the app avoids running into privacy issues, as streaming data elsewhere requires patient consent.
But algorithms need to be trained and tested by collecting reams of data, and that is an ongoing process.
Researchers, for example, have found that some computer vision applications, like heart rate or blood pressure monitoring, can be less accurate for darker skin. Studies are underway to find better solutions.
Small algorithm glitches can also produce false alarms and frighten patients enough to keep widespread adoption out of reach. For example, Apple’s new car-crash detection feature, available on both the latest iPhone and Apple Watch, was set off when people were riding roller coasters and automatically dialed 911.
“We’re not there yet,” Dr. Yang said. “That’s the bottom line.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
A fingertip pressed against a phone’s camera lens can measure a heart rate. The microphone, kept by the bedside, can screen for sleep apnea. Even the speaker is being tapped, to monitor breathing using sonar technology.
In the best of this new world, the data is conveyed remotely to a medical professional for the convenience and comfort of the patient or, in some cases, to support a clinician without the need for costly hardware.
But using smartphones as diagnostic tools is a work in progress, experts say. Although doctors and their patients have found some real-world success in deploying the phone as a medical device, the overall potential remains unfulfilled and uncertain.
Smartphones come packed with sensors capable of monitoring a patient’s vital signs. They can help assess people for concussions, watch for atrial fibrillation, and conduct mental health wellness checks, to name the uses of a few nascent applications.
Companies and researchers eager to find medical applications for smartphone technology are tapping into modern phones’ built-in cameras and light sensors; microphones; accelerometers, which detect body movements; gyroscopes; and even speakers. The apps then use artificial intelligence software to analyze the collected sights and sounds to create an easy connection between patients and physicians. Earning potential and marketability are evidenced by the more than 350,000 digital health products available in app stores, according to a Grand View Research report.
“It’s very hard to put devices into the patient home or in the hospital, but everybody is just walking around with a cellphone that has a network connection,” said Dr. Andrew Gostine, CEO of the sensor network company Artisight. Most Americans own a smartphone, including more than 60% of people 65 and over, an increase from just 13% a decade ago, according the Pew Research Center. The COVID-19 pandemic has also pushed people to become more comfortable with virtual care.
Some of these products have sought FDA clearance to be marketed as a medical device. That way, if patients must pay to use the software, health insurers are more likely to cover at least part of the cost. Other products are designated as exempt from this regulatory process, placed in the same clinical classification as a Band-Aid. But how the agency handles AI and machine learning–based medical devices is still being adjusted to reflect software’s adaptive nature.
Ensuring accuracy and clinical validation is crucial to securing buy-in from health care providers. And many tools still need fine-tuning, said Eugene Yang, MD, a professor of medicine at the University of Washington, Seattle. Currently, Dr. Yang is testing contactless measurement of blood pressure, heart rate, and oxygen saturation gleaned remotely via Zoom camera footage of a patient’s face.
Judging these new technologies is difficult because they rely on algorithms built by machine learning and artificial intelligence to collect data, rather than the physical tools typically used in hospitals. So researchers cannot “compare apples to apples” with medical industry standards, Dr. Yang said. Failure to build in such assurances undermines the technology’s ultimate goals of easing costs and access because a doctor still must verify results.
“False positives and false negatives lead to more testing and more cost to the health care system,” he said.
Big tech companies like Google have heavily invested in researching this kind of technology, catering to clinicians and in-home caregivers, as well as consumers. Currently, in the Google Fit app, users can check their heart rate by placing their finger on the rear-facing camera lens or track their breathing rate using the front-facing camera.
“If you took the sensor out of the phone and out of a clinical device, they are probably the same thing,” said Shwetak Patel, director of health technologies at Google and a professor of electrical and computer engineering at the University of Washington.
Google’s research uses machine learning and computer vision, a field within AI based on information from visual inputs like videos or images. So instead of using a blood pressure cuff, for example, the algorithm can interpret slight visual changes to the body that serve as proxies and biosignals for a patient’s blood pressure, Mr. Patel said.
Google is also investigating the effectiveness of the built-in microphone for detecting heartbeats and murmurs and using the camera to preserve eyesight by screening for diabetic eye disease, according to information the company published last year.
The tech giant recently purchased Sound Life Sciences, a Seattle startup with an FDA-cleared sonar technology app. It uses a smart device’s speaker to bounce inaudible pulses off a patient’s body to identify movement and monitor breathing.
Binah.ai, based in Israel, is another company using the smartphone camera to calculate vital signs. Its software looks at the region around the eyes, where the skin is a bit thinner, and analyzes the light reflecting off blood vessels back to the lens. The company is wrapping up a U.S. clinical trial and marketing its wellness app directly to insurers and other health companies, said company spokesperson Mona Popilian-Yona.
The applications even reach into disciplines such as optometry and mental health:
- With the microphone, Canary Speech uses the same underlying technology as Amazon’s Alexa to analyze patients’ voices for mental health conditions. The software can integrate with telemedicine appointments and allow clinicians to screen for anxiety and depression using a library of vocal biomarkers and predictive analytics, said Henry O’Connell, the company’s CEO.
- Australia-based ResApp Health last year for its iPhone app that screens for moderate to severe obstructive sleep apnea by listening to breathing and snoring. SleepCheckRx, which will require a prescription, is minimally invasive compared with sleep studies currently used to diagnose sleep apnea. Those can cost thousands of dollars and require an array of tests.
- Brightlamp’s Reflex app is a clinical decision support tool for helping manage concussions and vision rehabilitation, among other things. Using an iPad’s or iPhone’s camera, the mobile app measures how a person’s pupils react to changes in light. Through machine learning analysis, the imagery gives practitioners data points for evaluating patients. Brightlamp sells directly to health care providers and is being used in more than 230 clinics. Clinicians pay a $400 standard annual fee per account, which is currently not covered by insurance. The Department of Defense has an ongoing clinical trial using Reflex.
In some cases, such as with the Reflex app, the data is processed directly on the phone – rather than in the cloud, Brightlamp CEO Kurtis Sluss said. By processing everything on the device, the app avoids running into privacy issues, as streaming data elsewhere requires patient consent.
But algorithms need to be trained and tested by collecting reams of data, and that is an ongoing process.
Researchers, for example, have found that some computer vision applications, like heart rate or blood pressure monitoring, can be less accurate for darker skin. Studies are underway to find better solutions.
Small algorithm glitches can also produce false alarms and frighten patients enough to keep widespread adoption out of reach. For example, Apple’s new car-crash detection feature, available on both the latest iPhone and Apple Watch, was set off when people were riding roller coasters and automatically dialed 911.
“We’re not there yet,” Dr. Yang said. “That’s the bottom line.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Nitrite food additives may increase risk of type 2 diabetes
Consuming a large amount of nitrites from food additives versus none was associated with a greater risk of developing type 2 diabetes in the NutriNet-Santé study in France, researchers report.
However, a few experts who were not involved with this research question the strength of the findings because of study limitations.
The study involved more than 100,000 adults with a mean age of 43, and 79% were women.
Individuals with the highest intakes of nitrites from food additives (top third) had a 53% higher risk of developing type 2 diabetes during a median follow-up of 7 years compared with those with the lowest intake of this food additive after controlling for intake of sugars, red and processed meats, heme iron, salt, and saturated fatty acids. Consumption of nitrates from food additives was not associated with risk of type 2 diabetes.
“Our findings suggest a direct association between additives-originated nitrites and [type 2 diabetes] risk and corroborate previously suggested associations between total dietary nitrites and [type 2 diabetes],” the researchers report in an article published online in PLoS Medicine.
However, “as this is the first large-scale study finding these associations, these results need to be replicated in other large-scale cohorts,” senior author Mathilde Touvier, PhD, head of the Nutritional Epidemiology Research Team (EREN-CRESS), INSERM, INRAE, Sorbonne Paris Nord University, and lead author Bernard Srour, PhD, PharmD, a scientist at the same institution, said in a joint email to this news organization.
Short-term intervention studies to determine insulin resistance could also be tested, they add.
In the meantime, “this study adds further evidence to the existing strong link between nitrites and colorectal cancer risk, and supports the importance of further regulation of nitrites as food additives and nitrogen fertilizers,” they say.
According to Dr. Touvier and Dr. Srour, the takeaway message for clinicians is the finding that nitrites from food additives are associated with type 2 diabetes, “support existing guidelines recommending [limiting] the consumption of processed meats to prevent chronic diseases. However, the consumption of vegetables should be encouraged as they contain several beneficial compounds and contribute to chronic disease prevention.”
Some experts are skeptical
But three experts who were not involved with the research were skeptical about the conclusions, in comments made to the U.K. Science Media Centre.
“The fundamental weakness of this study is how the food additive intake was assessed,” said Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics, King’s College London. “Estimates of intake were based on recalls of dietary intake on two separate occasions at the beginning of the study with no further estimates in the follow-up period of over 7 years,” he noted.
Other limitations include the relatively young age of the cohort and relatively low incidence of new cases of type 2 diabetes (about 1% of the study population over 7 years).
Moreover, the level of nitrite food additive ingestion is much lower than the acceptable daily intake. The findings would need to be replicated with appropriate adjustment for differences in body weight.
Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading, England, said that “the study does not support the claim in the press release and paper that food additives are responsible for the increased risk.”
He pointed out that “nitrite from additives contributes only about 4%-6% of total nitrite intake in the population, and it is not clear why this should have a stronger impact on risk than nitrite from other sources,” such as nitrate found in food and water.
Duane Mellor, PhD, registered dietitian and senior lecturer, Aston University, Birmingham, England, said: “It could be questioned how accurate estimating intakes of individual additives like sodium nitrite, which was less than 1 mg per day from a record of just 2 days food intake per year, as it assumes people ate the same the other 363 days of the year.”
Moreover, “it is perhaps worth noting that the use of nitrites as an additive is often as sodium nitrite, which is used to cure meats like bacon, which if someone is seeking to reduce their risk of type 2 diabetes would be something people would be encouraged to eat less of [anyway].”
“The best way to reduce your risk of developing type 2 diabetes,” he said, “is to be physically active, maintain a healthy weight for you, and eat a varied diet based on vegetables, pulses, nuts, seeds, and fruit along with wholegrain and moderate intakes of dairy foods and meat (especially processed meats).”
Study details
Nitrites and nitrates are used as food additives to prevent bacterial growth, mainly in processed meats, and they are also found in foods (mainly green leafy vegetables) and water (nitrates from the use of nitrogen fertilizer can enter the water supply).
The researchers analyzed data from 104,168 participants in NutriNet-Santé who had no diabetes at baseline and who completed 24-hour dietary intake records. They investigated the association between exposure to nitrites and nitrates (in food and water or in additives) and incident type 2 diabetes.
Most nitrites came from food (95.3%), and less often from food additives (4.7%) and water (< 0.01%). The nitrites in foods were mainly from vegetables (60%) and seasonings (23%).
Most nitrates also came from food (93%), followed by water (6.9%) and food additives (0.1%). The nitrates in foods were mainly from vegetables (41%), processed meat (19%), and meat (17%).
During a median follow-up of 7.3 years, there were 969 incident cases of type 2 diabetes.
Compared with individuals in the lowest third of nitrites from food and water, those in the highest tertile had a 27% higher risk of incident type 2 diabetes, after adjusting for multiple variables (hazard ratio, 1.27; P = .009).
The risk of type 2 diabetes associated with the highest intake of nitrites from additives was as previously described, 53% higher, than that for those with the lowest intake.
There was no evidence of an association between nitrates and risk of type 2 diabetes.
The researchers acknowledge that study limitations include potential errors in assessment of nitrate and nitrate exposure, potential selection bias (participants in the web-based study may have had healthier behaviors than the general population), and potential unaccounted confounders (because it was an observational study).
A version of this article first appeared on Medscape.com.
Consuming a large amount of nitrites from food additives versus none was associated with a greater risk of developing type 2 diabetes in the NutriNet-Santé study in France, researchers report.
However, a few experts who were not involved with this research question the strength of the findings because of study limitations.
The study involved more than 100,000 adults with a mean age of 43, and 79% were women.
Individuals with the highest intakes of nitrites from food additives (top third) had a 53% higher risk of developing type 2 diabetes during a median follow-up of 7 years compared with those with the lowest intake of this food additive after controlling for intake of sugars, red and processed meats, heme iron, salt, and saturated fatty acids. Consumption of nitrates from food additives was not associated with risk of type 2 diabetes.
“Our findings suggest a direct association between additives-originated nitrites and [type 2 diabetes] risk and corroborate previously suggested associations between total dietary nitrites and [type 2 diabetes],” the researchers report in an article published online in PLoS Medicine.
However, “as this is the first large-scale study finding these associations, these results need to be replicated in other large-scale cohorts,” senior author Mathilde Touvier, PhD, head of the Nutritional Epidemiology Research Team (EREN-CRESS), INSERM, INRAE, Sorbonne Paris Nord University, and lead author Bernard Srour, PhD, PharmD, a scientist at the same institution, said in a joint email to this news organization.
Short-term intervention studies to determine insulin resistance could also be tested, they add.
In the meantime, “this study adds further evidence to the existing strong link between nitrites and colorectal cancer risk, and supports the importance of further regulation of nitrites as food additives and nitrogen fertilizers,” they say.
According to Dr. Touvier and Dr. Srour, the takeaway message for clinicians is the finding that nitrites from food additives are associated with type 2 diabetes, “support existing guidelines recommending [limiting] the consumption of processed meats to prevent chronic diseases. However, the consumption of vegetables should be encouraged as they contain several beneficial compounds and contribute to chronic disease prevention.”
Some experts are skeptical
But three experts who were not involved with the research were skeptical about the conclusions, in comments made to the U.K. Science Media Centre.
“The fundamental weakness of this study is how the food additive intake was assessed,” said Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics, King’s College London. “Estimates of intake were based on recalls of dietary intake on two separate occasions at the beginning of the study with no further estimates in the follow-up period of over 7 years,” he noted.
Other limitations include the relatively young age of the cohort and relatively low incidence of new cases of type 2 diabetes (about 1% of the study population over 7 years).
Moreover, the level of nitrite food additive ingestion is much lower than the acceptable daily intake. The findings would need to be replicated with appropriate adjustment for differences in body weight.
Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading, England, said that “the study does not support the claim in the press release and paper that food additives are responsible for the increased risk.”
He pointed out that “nitrite from additives contributes only about 4%-6% of total nitrite intake in the population, and it is not clear why this should have a stronger impact on risk than nitrite from other sources,” such as nitrate found in food and water.
Duane Mellor, PhD, registered dietitian and senior lecturer, Aston University, Birmingham, England, said: “It could be questioned how accurate estimating intakes of individual additives like sodium nitrite, which was less than 1 mg per day from a record of just 2 days food intake per year, as it assumes people ate the same the other 363 days of the year.”
Moreover, “it is perhaps worth noting that the use of nitrites as an additive is often as sodium nitrite, which is used to cure meats like bacon, which if someone is seeking to reduce their risk of type 2 diabetes would be something people would be encouraged to eat less of [anyway].”
“The best way to reduce your risk of developing type 2 diabetes,” he said, “is to be physically active, maintain a healthy weight for you, and eat a varied diet based on vegetables, pulses, nuts, seeds, and fruit along with wholegrain and moderate intakes of dairy foods and meat (especially processed meats).”
Study details
Nitrites and nitrates are used as food additives to prevent bacterial growth, mainly in processed meats, and they are also found in foods (mainly green leafy vegetables) and water (nitrates from the use of nitrogen fertilizer can enter the water supply).
The researchers analyzed data from 104,168 participants in NutriNet-Santé who had no diabetes at baseline and who completed 24-hour dietary intake records. They investigated the association between exposure to nitrites and nitrates (in food and water or in additives) and incident type 2 diabetes.
Most nitrites came from food (95.3%), and less often from food additives (4.7%) and water (< 0.01%). The nitrites in foods were mainly from vegetables (60%) and seasonings (23%).
Most nitrates also came from food (93%), followed by water (6.9%) and food additives (0.1%). The nitrates in foods were mainly from vegetables (41%), processed meat (19%), and meat (17%).
During a median follow-up of 7.3 years, there were 969 incident cases of type 2 diabetes.
Compared with individuals in the lowest third of nitrites from food and water, those in the highest tertile had a 27% higher risk of incident type 2 diabetes, after adjusting for multiple variables (hazard ratio, 1.27; P = .009).
The risk of type 2 diabetes associated with the highest intake of nitrites from additives was as previously described, 53% higher, than that for those with the lowest intake.
There was no evidence of an association between nitrates and risk of type 2 diabetes.
The researchers acknowledge that study limitations include potential errors in assessment of nitrate and nitrate exposure, potential selection bias (participants in the web-based study may have had healthier behaviors than the general population), and potential unaccounted confounders (because it was an observational study).
A version of this article first appeared on Medscape.com.
Consuming a large amount of nitrites from food additives versus none was associated with a greater risk of developing type 2 diabetes in the NutriNet-Santé study in France, researchers report.
However, a few experts who were not involved with this research question the strength of the findings because of study limitations.
The study involved more than 100,000 adults with a mean age of 43, and 79% were women.
Individuals with the highest intakes of nitrites from food additives (top third) had a 53% higher risk of developing type 2 diabetes during a median follow-up of 7 years compared with those with the lowest intake of this food additive after controlling for intake of sugars, red and processed meats, heme iron, salt, and saturated fatty acids. Consumption of nitrates from food additives was not associated with risk of type 2 diabetes.
“Our findings suggest a direct association between additives-originated nitrites and [type 2 diabetes] risk and corroborate previously suggested associations between total dietary nitrites and [type 2 diabetes],” the researchers report in an article published online in PLoS Medicine.
However, “as this is the first large-scale study finding these associations, these results need to be replicated in other large-scale cohorts,” senior author Mathilde Touvier, PhD, head of the Nutritional Epidemiology Research Team (EREN-CRESS), INSERM, INRAE, Sorbonne Paris Nord University, and lead author Bernard Srour, PhD, PharmD, a scientist at the same institution, said in a joint email to this news organization.
Short-term intervention studies to determine insulin resistance could also be tested, they add.
In the meantime, “this study adds further evidence to the existing strong link between nitrites and colorectal cancer risk, and supports the importance of further regulation of nitrites as food additives and nitrogen fertilizers,” they say.
According to Dr. Touvier and Dr. Srour, the takeaway message for clinicians is the finding that nitrites from food additives are associated with type 2 diabetes, “support existing guidelines recommending [limiting] the consumption of processed meats to prevent chronic diseases. However, the consumption of vegetables should be encouraged as they contain several beneficial compounds and contribute to chronic disease prevention.”
Some experts are skeptical
But three experts who were not involved with the research were skeptical about the conclusions, in comments made to the U.K. Science Media Centre.
“The fundamental weakness of this study is how the food additive intake was assessed,” said Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics, King’s College London. “Estimates of intake were based on recalls of dietary intake on two separate occasions at the beginning of the study with no further estimates in the follow-up period of over 7 years,” he noted.
Other limitations include the relatively young age of the cohort and relatively low incidence of new cases of type 2 diabetes (about 1% of the study population over 7 years).
Moreover, the level of nitrite food additive ingestion is much lower than the acceptable daily intake. The findings would need to be replicated with appropriate adjustment for differences in body weight.
Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading, England, said that “the study does not support the claim in the press release and paper that food additives are responsible for the increased risk.”
He pointed out that “nitrite from additives contributes only about 4%-6% of total nitrite intake in the population, and it is not clear why this should have a stronger impact on risk than nitrite from other sources,” such as nitrate found in food and water.
Duane Mellor, PhD, registered dietitian and senior lecturer, Aston University, Birmingham, England, said: “It could be questioned how accurate estimating intakes of individual additives like sodium nitrite, which was less than 1 mg per day from a record of just 2 days food intake per year, as it assumes people ate the same the other 363 days of the year.”
Moreover, “it is perhaps worth noting that the use of nitrites as an additive is often as sodium nitrite, which is used to cure meats like bacon, which if someone is seeking to reduce their risk of type 2 diabetes would be something people would be encouraged to eat less of [anyway].”
“The best way to reduce your risk of developing type 2 diabetes,” he said, “is to be physically active, maintain a healthy weight for you, and eat a varied diet based on vegetables, pulses, nuts, seeds, and fruit along with wholegrain and moderate intakes of dairy foods and meat (especially processed meats).”
Study details
Nitrites and nitrates are used as food additives to prevent bacterial growth, mainly in processed meats, and they are also found in foods (mainly green leafy vegetables) and water (nitrates from the use of nitrogen fertilizer can enter the water supply).
The researchers analyzed data from 104,168 participants in NutriNet-Santé who had no diabetes at baseline and who completed 24-hour dietary intake records. They investigated the association between exposure to nitrites and nitrates (in food and water or in additives) and incident type 2 diabetes.
Most nitrites came from food (95.3%), and less often from food additives (4.7%) and water (< 0.01%). The nitrites in foods were mainly from vegetables (60%) and seasonings (23%).
Most nitrates also came from food (93%), followed by water (6.9%) and food additives (0.1%). The nitrates in foods were mainly from vegetables (41%), processed meat (19%), and meat (17%).
During a median follow-up of 7.3 years, there were 969 incident cases of type 2 diabetes.
Compared with individuals in the lowest third of nitrites from food and water, those in the highest tertile had a 27% higher risk of incident type 2 diabetes, after adjusting for multiple variables (hazard ratio, 1.27; P = .009).
The risk of type 2 diabetes associated with the highest intake of nitrites from additives was as previously described, 53% higher, than that for those with the lowest intake.
There was no evidence of an association between nitrates and risk of type 2 diabetes.
The researchers acknowledge that study limitations include potential errors in assessment of nitrate and nitrate exposure, potential selection bias (participants in the web-based study may have had healthier behaviors than the general population), and potential unaccounted confounders (because it was an observational study).
A version of this article first appeared on Medscape.com.
FROM PLOS MEDICINE



