Cardiology News

When the hospital’s trauma team could not get an IV inserted into an accident victim, they called Illinois emergency physician William Sullivan, DO, JD, for help. Dr. Sullivan, who is based in the Chicago suburb of Frankfort, inserted a central line into the patient’s leg on his first attempt – a task that took about 20 minutes.

A year later, Dr. Sullivan was shocked and angry to learn he was being sued by the trauma patient’s family. Inserting the line was his only interaction with the woman, and he had no role in her care management, he said. Yet, the suit claimed he was negligent for failing to diagnose the patient with internal bleeding and for not performing surgery. 

“The lawsuit put a lot of stress on our family,” Dr. Sullivan recalled. “At the time my wife was pregnant. I was in law school, and I was also working full time in the ER to support our family. I remember my wife crying on the couch after reading the complaint and asking how the plaintiff’s attorney could get away with making the allegations he made.”

Dr. Sullivan soon learned that 15 medical providers in the patient’s medical record were named as defendants. This included the director of the radiology department, whose name was on a radiology report as “director” but who was actually out of the country when the incident occurred.

Despite some of the accusations being impossible, a medical expert had claimed there was a “meritorious claim” against every health professional named in the suit. Illinois is among the 28 states that require plaintiffs’ attorneys to file an affidavit of merit for medical malpractice claims to move forward.

Dr. Sullivan wondered who would endorse such outlandish accusations, but the expert’s identity was a mystery. According to Illinois law, plaintiffs’ attorneys can withhold the identity of medical experts with whom they consult for affidavits of merit. About one-third of states with merit requirements permit anonymous experts, according to research and attorneys familiar with the issue.

Because the expert’s identity remains hidden, physicians have no way of knowing whether they were qualified to render an opinion, Dr. Sullivan said. The loopholes can drag out frivolous claims and waste significant time and expense, say legal experts. Frequently, it takes a year or more before innocent physicians are dismissed from unfounded lawsuits by the court or dropped when plaintiffs can’t support the claim.

“It’s hugely frustrating,” said Bruce Montoya, JD, a Colorado medical liability defense attorney. “You have an expert who is not disclosed. Further down the road, when experts are being deposed, the plaintiff does not have to reveal whether any of those testifying experts is the same one who certified the case. You never get to determine whether they, in fact, had a certificate reviewer who was legitimate.”

The laws have led to a recent outcry among physicians and fueled a revised resolution by the American College of Emergency Physicians (ACEP) denouncing anonymous affidavits of merit. (The revision has not yet been published online.)

“The minute experts are identified, they can be vetted,” said Rade B. Vukmir, MD, JD, chair of ACEP’s Medical Legal Committee. “There are reasons that you want to clarify the qualification and veracity of the witness. [Anonymous affidavits of merit] don’t allow that, and there’s something inherently wrong with that.”

Because the identities of consulting experts are unknown, it’s hard to know how many are unqualified. Expert witnesses who testify during trials, on the other hand, have long come under scrutiny for questionable qualifications. Some have come under fire for allegedly lying under oath about their experience, misrepresenting their credentials, and falsely representing their knowledge.

“Considering the known problem of potentially unethical expert witness testimony at trial, there’s is the potential likelihood that experts in anonymous affidavits of merit may sometimes lack the qualifications to give opinions,” said Dr. Vukmir, an emergency care physician in Pittsburgh.
 

Attorneys: Hidden experts increase costs, waste time

In Colorado, Mr. Montoya has seen firsthand how anonymous experts can prolong questionable claims and burden defendants.

Like Illinois, Colorado does not require attorneys to identify the medical experts used to fulfill its certificate of review statute. The expert consulted must have expertise in the same area of the alleged negligence, but does not have to practice in the same specialty, and the statute allows one expert to certify a lawsuit against multiple doctors.

In a recent case, Mr. Montoya represented a Denver neurosurgeon who was sued along with multiple other health care professionals. From the outset, Mr. Montoya argued the claim had no merit against the neurosurgeon, but the plaintiff’s attorney refused to dismiss the physician. Mr. Montoya asked whether the expert consulted for the certificate of merit was a neurosurgeon, but the attorney declined to disclose that information, he said.

The case progressed and Mr. Montoya eventually asked the judge to review the certificate of merit. By law, a judge can confidentially review the certificate of merit and decide whether it aligns with the state statute, but without disclosing the expert’s identity to the defense. The judge ruled the certificate appeared to conform with state law, and the case continued.

A year later, as both sides were getting ready to disclose their experts who would testify, Mr. Montoya again argued the neurosurgeon should be dropped from the suit. This time, he warned if the claim continued against the neurosurgeon, the defense would be filing a motion for summary judgment and pursuing attorney fees and costs. Colorado law allows for such fees if the filing or pursuit of an action is frivolous.

“Boom, my client was dismissed,” Mr. Montoya said. “This is a year later, after multiple conferences among the attorneys, multiple pleadings filed, expert witnesses retained to review the care, discovery exchanged, and records obtained. If we had [a stronger] certificate of review statute, it would have been a different ballgame. It’s never going to get a year down the road.”

In New York, physician defendants have experienced similar woes. The state’s law requires plaintiffs’ attorneys to certify that they consulted with a physician prior to filing the claim, and that they believe based on that discussion, there’s a reasonable basis for the claim to move forward. Attorneys are not required to disclose the expert’s identity.

The law also allows “an out,” explained Morris Auster, JD, senior vice president and chief legislative counsel for the Medical Society of the State of New York. If the attorney made three separate attempts to obtain a consultation, and all three experts would not agree to the consultation, the lawsuit can be filed anyway, he said.

“From our standpoint, it’s important to have an affidavit of merit requirement; it’s better than not having it,” Mr. Auster said. “But its effectiveness in providing control over the filing of lawsuits in New York has never been as strong as it could’ve been.”

Mr. Auster notes that New York has some of the highest liability costs in the country in addition to doctors paying some of the steepest medical liability insurance premiums.

“This really affects a lot of physicians and it’s driving physicians into employment arrangements, so they don’t have to deal with it on their own,” he said. “We support a number of measures to address these significantly high costs, and stronger certificate of merit requirements would certainly be one of those advocacy goals.”
 

Why are anonymous experts allowed?

Certificates of merit that shield the identity of consultants encourage a greater pool of physicians willing to review cases, said J. Matthew Dudley, JD, president of the Illinois Trial Lawyers Association. When the requirements first went into effect in Illinois, there was significant animosity among physicians toward doctors who testified in medical malpractice cases for patients, Mr. Dudley explained.

“Sometimes they would be ostracized from their professional societies, or it would hurt a referral relationship.” he said. “Over time, that animosity has lessened, but there was a concern that if the identity of physicians in certificates of merit weren’t protected, then doctors would not look at cases for patients.”

This would result in additional barriers for patients and their attorneys in pursuing their legal rights, Mr. Dudley said. He said Illinois’ certificate of merit statute is successful in fulfilling its intended purpose, and he has not seen any statistical evidence to suggest otherwise.

“It has proven effective at decreasing filings in medical malpractice and effectively screening medical malpractice cases,” he said. “Certificates of merit help to decrease filings by firms that aren’t that experienced in dealing with those kinds of cases.”

Kentucky is another state that does not require attorneys to identity the experts consulted for certificates of merit. Malpractice defense attorney Andrew DeSimone, JD, who practices in Kentucky, said this isn’t a problem since attorneys eventually must disclose the expert witnesses who will testify at trial.

“Knowing the name behind the certificate of merit is not that pertinent,” Mr. DeSimone said. “Physicians and their attorneys will ultimately have the chance to question and evaluate the expert witnesses used at trial. The certificate of merit is designed to weed out totally frivolous cases that do not have expert support. It’s not designed to be a trial on the merits.” 

The belief that plaintiffs’ attorneys frequently bring weak cases and use unqualified experts to certify claims is not realistic or logical, added Sean Domnick, JD, a Florida medical malpractice attorney and vice president for the American Association for Justice. Medical malpractice cases are extremely challenging for plaintiffs – and they’re expensive, Mr. Domnick said.  

“We can’t afford to take bad cases,” he said. “For me to take on a medical malpractice case, it’s not unusual for me to spend well over $100,000. Remember, if we lose, I don’t get that money back and I don’t get paid. Why in the world would a plaintiff take on that type of a burden for a case they didn’t believe in? The logic escapes me.”

In Florida, where Mr. Domnick practices, plaintiffs’ attorneys must send their certificates of merit to the defense with the expert identified. Domnick believes the requirement is a hindrance.

“It creates a delay that is unnecessary in a system that is already designed to wear our clients down,” he said. “It’s just another component that makes it harder on them.”
 

Hidden experts may insulate plaintiffs’ attorneys from liability

Dr. Sullivan, the Illinois emergency physician, was ultimately dismissed from the multiparty lawsuit, but not for roughly 18 months. After the dismissal, he fought back. He sued the plaintiff’s law firm for malicious prosecution, negligence in hiring, and relying on the opinion of an expert who was unqualified to render an opinion against an emergency physician.

The law firm, however, argued that it was immune from liability because it reasonably relied on the expert’s opinion as required by Illinois law. A trial court agreed with the plaintiffs’ firm. The judge denied Dr. Sullivan’s request to identify the expert, ruling there was no finding that the affidavit was untrue or made without reasonable cause. Dr. Sullivan appealed, and the appellate court upheld the trial’s court decision.

“As happened with my case, law firms can use the affidavit as a defense against countersuits or motions for sanctions,” Dr. Sullivan said. “Although the certificate of merit is intended to prevent attorneys from filing frivolous cases, it can also have the opposite effect of helping to insulate plaintiff attorneys from liability for filing a frivolous lawsuit.”

In Colorado, complaints about the state’s certificate of merit statute have gone before the Colorado Supreme Court. In one case, a lower court ruled that a certificate of merit was deficient because the consultants were not chiropractors. In another case, a nurse defendant argued the claim’s certificate of review was insufficient because the consulting expert was a physician.

In both instances, Colorado judges held the state’s statute does not require consultants to be in the same profession or the same specialty as the health professional defendant. 

In New York, meanwhile, Mr. Auster said several bills to strengthen the state’s certificate of merit requirements have failed in recent years.

“It’s hard to say whether it will improve anytime soon,” he said. “The trial lawyers are a very powerful advocacy force in the state, and they tend to oppose even the slightest of changes in civil liability. [In addition], some of these issues have been put on a lower tier because of trying to manage the pandemic.”

Ultimately, Dr. Sullivan said that courts and legislatures need to strongly consider the ethics of allowing anonymous experts to provide testimony against defendant physicians.

“I also think we need to consider how the notion of a secret expert comports with a defendant physician’s due process,” he said. “If an expert’s opinion is appropriate, why would there be a need to shroud one’s identity in a veil of secrecy?” 

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

When the hospital’s trauma team could not get an IV inserted into an accident victim, they called Illinois emergency physician William Sullivan, DO, JD, for help. Dr. Sullivan, who is based in the Chicago suburb of Frankfort, inserted a central line into the patient’s leg on his first attempt – a task that took about 20 minutes.

A year later, Dr. Sullivan was shocked and angry to learn he was being sued by the trauma patient’s family. Inserting the line was his only interaction with the woman, and he had no role in her care management, he said. Yet, the suit claimed he was negligent for failing to diagnose the patient with internal bleeding and for not performing surgery. 

“The lawsuit put a lot of stress on our family,” Dr. Sullivan recalled. “At the time my wife was pregnant. I was in law school, and I was also working full time in the ER to support our family. I remember my wife crying on the couch after reading the complaint and asking how the plaintiff’s attorney could get away with making the allegations he made.”

Dr. Sullivan soon learned that 15 medical providers in the patient’s medical record were named as defendants. This included the director of the radiology department, whose name was on a radiology report as “director” but who was actually out of the country when the incident occurred.

Despite some of the accusations being impossible, a medical expert had claimed there was a “meritorious claim” against every health professional named in the suit. Illinois is among the 28 states that require plaintiffs’ attorneys to file an affidavit of merit for medical malpractice claims to move forward.

Dr. Sullivan wondered who would endorse such outlandish accusations, but the expert’s identity was a mystery. According to Illinois law, plaintiffs’ attorneys can withhold the identity of medical experts with whom they consult for affidavits of merit. About one-third of states with merit requirements permit anonymous experts, according to research and attorneys familiar with the issue.

Because the expert’s identity remains hidden, physicians have no way of knowing whether they were qualified to render an opinion, Dr. Sullivan said. The loopholes can drag out frivolous claims and waste significant time and expense, say legal experts. Frequently, it takes a year or more before innocent physicians are dismissed from unfounded lawsuits by the court or dropped when plaintiffs can’t support the claim.

“It’s hugely frustrating,” said Bruce Montoya, JD, a Colorado medical liability defense attorney. “You have an expert who is not disclosed. Further down the road, when experts are being deposed, the plaintiff does not have to reveal whether any of those testifying experts is the same one who certified the case. You never get to determine whether they, in fact, had a certificate reviewer who was legitimate.”

The laws have led to a recent outcry among physicians and fueled a revised resolution by the American College of Emergency Physicians (ACEP) denouncing anonymous affidavits of merit. (The revision has not yet been published online.)

“The minute experts are identified, they can be vetted,” said Rade B. Vukmir, MD, JD, chair of ACEP’s Medical Legal Committee. “There are reasons that you want to clarify the qualification and veracity of the witness. [Anonymous affidavits of merit] don’t allow that, and there’s something inherently wrong with that.”

Because the identities of consulting experts are unknown, it’s hard to know how many are unqualified. Expert witnesses who testify during trials, on the other hand, have long come under scrutiny for questionable qualifications. Some have come under fire for allegedly lying under oath about their experience, misrepresenting their credentials, and falsely representing their knowledge.

“Considering the known problem of potentially unethical expert witness testimony at trial, there’s is the potential likelihood that experts in anonymous affidavits of merit may sometimes lack the qualifications to give opinions,” said Dr. Vukmir, an emergency care physician in Pittsburgh.
 

Attorneys: Hidden experts increase costs, waste time

In Colorado, Mr. Montoya has seen firsthand how anonymous experts can prolong questionable claims and burden defendants.

Like Illinois, Colorado does not require attorneys to identify the medical experts used to fulfill its certificate of review statute. The expert consulted must have expertise in the same area of the alleged negligence, but does not have to practice in the same specialty, and the statute allows one expert to certify a lawsuit against multiple doctors.

In a recent case, Mr. Montoya represented a Denver neurosurgeon who was sued along with multiple other health care professionals. From the outset, Mr. Montoya argued the claim had no merit against the neurosurgeon, but the plaintiff’s attorney refused to dismiss the physician. Mr. Montoya asked whether the expert consulted for the certificate of merit was a neurosurgeon, but the attorney declined to disclose that information, he said.

The case progressed and Mr. Montoya eventually asked the judge to review the certificate of merit. By law, a judge can confidentially review the certificate of merit and decide whether it aligns with the state statute, but without disclosing the expert’s identity to the defense. The judge ruled the certificate appeared to conform with state law, and the case continued.

A year later, as both sides were getting ready to disclose their experts who would testify, Mr. Montoya again argued the neurosurgeon should be dropped from the suit. This time, he warned if the claim continued against the neurosurgeon, the defense would be filing a motion for summary judgment and pursuing attorney fees and costs. Colorado law allows for such fees if the filing or pursuit of an action is frivolous.

“Boom, my client was dismissed,” Mr. Montoya said. “This is a year later, after multiple conferences among the attorneys, multiple pleadings filed, expert witnesses retained to review the care, discovery exchanged, and records obtained. If we had [a stronger] certificate of review statute, it would have been a different ballgame. It’s never going to get a year down the road.”

In New York, physician defendants have experienced similar woes. The state’s law requires plaintiffs’ attorneys to certify that they consulted with a physician prior to filing the claim, and that they believe based on that discussion, there’s a reasonable basis for the claim to move forward. Attorneys are not required to disclose the expert’s identity.

The law also allows “an out,” explained Morris Auster, JD, senior vice president and chief legislative counsel for the Medical Society of the State of New York. If the attorney made three separate attempts to obtain a consultation, and all three experts would not agree to the consultation, the lawsuit can be filed anyway, he said.

“From our standpoint, it’s important to have an affidavit of merit requirement; it’s better than not having it,” Mr. Auster said. “But its effectiveness in providing control over the filing of lawsuits in New York has never been as strong as it could’ve been.”

Mr. Auster notes that New York has some of the highest liability costs in the country in addition to doctors paying some of the steepest medical liability insurance premiums.

“This really affects a lot of physicians and it’s driving physicians into employment arrangements, so they don’t have to deal with it on their own,” he said. “We support a number of measures to address these significantly high costs, and stronger certificate of merit requirements would certainly be one of those advocacy goals.”
 

Why are anonymous experts allowed?

Certificates of merit that shield the identity of consultants encourage a greater pool of physicians willing to review cases, said J. Matthew Dudley, JD, president of the Illinois Trial Lawyers Association. When the requirements first went into effect in Illinois, there was significant animosity among physicians toward doctors who testified in medical malpractice cases for patients, Mr. Dudley explained.

“Sometimes they would be ostracized from their professional societies, or it would hurt a referral relationship.” he said. “Over time, that animosity has lessened, but there was a concern that if the identity of physicians in certificates of merit weren’t protected, then doctors would not look at cases for patients.”

This would result in additional barriers for patients and their attorneys in pursuing their legal rights, Mr. Dudley said. He said Illinois’ certificate of merit statute is successful in fulfilling its intended purpose, and he has not seen any statistical evidence to suggest otherwise.

“It has proven effective at decreasing filings in medical malpractice and effectively screening medical malpractice cases,” he said. “Certificates of merit help to decrease filings by firms that aren’t that experienced in dealing with those kinds of cases.”

Kentucky is another state that does not require attorneys to identity the experts consulted for certificates of merit. Malpractice defense attorney Andrew DeSimone, JD, who practices in Kentucky, said this isn’t a problem since attorneys eventually must disclose the expert witnesses who will testify at trial.

“Knowing the name behind the certificate of merit is not that pertinent,” Mr. DeSimone said. “Physicians and their attorneys will ultimately have the chance to question and evaluate the expert witnesses used at trial. The certificate of merit is designed to weed out totally frivolous cases that do not have expert support. It’s not designed to be a trial on the merits.” 

The belief that plaintiffs’ attorneys frequently bring weak cases and use unqualified experts to certify claims is not realistic or logical, added Sean Domnick, JD, a Florida medical malpractice attorney and vice president for the American Association for Justice. Medical malpractice cases are extremely challenging for plaintiffs – and they’re expensive, Mr. Domnick said.  

“We can’t afford to take bad cases,” he said. “For me to take on a medical malpractice case, it’s not unusual for me to spend well over $100,000. Remember, if we lose, I don’t get that money back and I don’t get paid. Why in the world would a plaintiff take on that type of a burden for a case they didn’t believe in? The logic escapes me.”

In Florida, where Mr. Domnick practices, plaintiffs’ attorneys must send their certificates of merit to the defense with the expert identified. Domnick believes the requirement is a hindrance.

“It creates a delay that is unnecessary in a system that is already designed to wear our clients down,” he said. “It’s just another component that makes it harder on them.”
 

Hidden experts may insulate plaintiffs’ attorneys from liability

Dr. Sullivan, the Illinois emergency physician, was ultimately dismissed from the multiparty lawsuit, but not for roughly 18 months. After the dismissal, he fought back. He sued the plaintiff’s law firm for malicious prosecution, negligence in hiring, and relying on the opinion of an expert who was unqualified to render an opinion against an emergency physician.

The law firm, however, argued that it was immune from liability because it reasonably relied on the expert’s opinion as required by Illinois law. A trial court agreed with the plaintiffs’ firm. The judge denied Dr. Sullivan’s request to identify the expert, ruling there was no finding that the affidavit was untrue or made without reasonable cause. Dr. Sullivan appealed, and the appellate court upheld the trial’s court decision.

“As happened with my case, law firms can use the affidavit as a defense against countersuits or motions for sanctions,” Dr. Sullivan said. “Although the certificate of merit is intended to prevent attorneys from filing frivolous cases, it can also have the opposite effect of helping to insulate plaintiff attorneys from liability for filing a frivolous lawsuit.”

In Colorado, complaints about the state’s certificate of merit statute have gone before the Colorado Supreme Court. In one case, a lower court ruled that a certificate of merit was deficient because the consultants were not chiropractors. In another case, a nurse defendant argued the claim’s certificate of review was insufficient because the consulting expert was a physician.

In both instances, Colorado judges held the state’s statute does not require consultants to be in the same profession or the same specialty as the health professional defendant. 

In New York, meanwhile, Mr. Auster said several bills to strengthen the state’s certificate of merit requirements have failed in recent years.

“It’s hard to say whether it will improve anytime soon,” he said. “The trial lawyers are a very powerful advocacy force in the state, and they tend to oppose even the slightest of changes in civil liability. [In addition], some of these issues have been put on a lower tier because of trying to manage the pandemic.”

Ultimately, Dr. Sullivan said that courts and legislatures need to strongly consider the ethics of allowing anonymous experts to provide testimony against defendant physicians.

“I also think we need to consider how the notion of a secret expert comports with a defendant physician’s due process,” he said. “If an expert’s opinion is appropriate, why would there be a need to shroud one’s identity in a veil of secrecy?” 

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

When the hospital’s trauma team could not get an IV inserted into an accident victim, they called Illinois emergency physician William Sullivan, DO, JD, for help. Dr. Sullivan, who is based in the Chicago suburb of Frankfort, inserted a central line into the patient’s leg on his first attempt – a task that took about 20 minutes.

A year later, Dr. Sullivan was shocked and angry to learn he was being sued by the trauma patient’s family. Inserting the line was his only interaction with the woman, and he had no role in her care management, he said. Yet, the suit claimed he was negligent for failing to diagnose the patient with internal bleeding and for not performing surgery. 

“The lawsuit put a lot of stress on our family,” Dr. Sullivan recalled. “At the time my wife was pregnant. I was in law school, and I was also working full time in the ER to support our family. I remember my wife crying on the couch after reading the complaint and asking how the plaintiff’s attorney could get away with making the allegations he made.”

Dr. Sullivan soon learned that 15 medical providers in the patient’s medical record were named as defendants. This included the director of the radiology department, whose name was on a radiology report as “director” but who was actually out of the country when the incident occurred.

Despite some of the accusations being impossible, a medical expert had claimed there was a “meritorious claim” against every health professional named in the suit. Illinois is among the 28 states that require plaintiffs’ attorneys to file an affidavit of merit for medical malpractice claims to move forward.

Dr. Sullivan wondered who would endorse such outlandish accusations, but the expert’s identity was a mystery. According to Illinois law, plaintiffs’ attorneys can withhold the identity of medical experts with whom they consult for affidavits of merit. About one-third of states with merit requirements permit anonymous experts, according to research and attorneys familiar with the issue.

Because the expert’s identity remains hidden, physicians have no way of knowing whether they were qualified to render an opinion, Dr. Sullivan said. The loopholes can drag out frivolous claims and waste significant time and expense, say legal experts. Frequently, it takes a year or more before innocent physicians are dismissed from unfounded lawsuits by the court or dropped when plaintiffs can’t support the claim.

“It’s hugely frustrating,” said Bruce Montoya, JD, a Colorado medical liability defense attorney. “You have an expert who is not disclosed. Further down the road, when experts are being deposed, the plaintiff does not have to reveal whether any of those testifying experts is the same one who certified the case. You never get to determine whether they, in fact, had a certificate reviewer who was legitimate.”

The laws have led to a recent outcry among physicians and fueled a revised resolution by the American College of Emergency Physicians (ACEP) denouncing anonymous affidavits of merit. (The revision has not yet been published online.)

“The minute experts are identified, they can be vetted,” said Rade B. Vukmir, MD, JD, chair of ACEP’s Medical Legal Committee. “There are reasons that you want to clarify the qualification and veracity of the witness. [Anonymous affidavits of merit] don’t allow that, and there’s something inherently wrong with that.”

Because the identities of consulting experts are unknown, it’s hard to know how many are unqualified. Expert witnesses who testify during trials, on the other hand, have long come under scrutiny for questionable qualifications. Some have come under fire for allegedly lying under oath about their experience, misrepresenting their credentials, and falsely representing their knowledge.

“Considering the known problem of potentially unethical expert witness testimony at trial, there’s is the potential likelihood that experts in anonymous affidavits of merit may sometimes lack the qualifications to give opinions,” said Dr. Vukmir, an emergency care physician in Pittsburgh.
 

Attorneys: Hidden experts increase costs, waste time

In Colorado, Mr. Montoya has seen firsthand how anonymous experts can prolong questionable claims and burden defendants.

Like Illinois, Colorado does not require attorneys to identify the medical experts used to fulfill its certificate of review statute. The expert consulted must have expertise in the same area of the alleged negligence, but does not have to practice in the same specialty, and the statute allows one expert to certify a lawsuit against multiple doctors.

In a recent case, Mr. Montoya represented a Denver neurosurgeon who was sued along with multiple other health care professionals. From the outset, Mr. Montoya argued the claim had no merit against the neurosurgeon, but the plaintiff’s attorney refused to dismiss the physician. Mr. Montoya asked whether the expert consulted for the certificate of merit was a neurosurgeon, but the attorney declined to disclose that information, he said.

The case progressed and Mr. Montoya eventually asked the judge to review the certificate of merit. By law, a judge can confidentially review the certificate of merit and decide whether it aligns with the state statute, but without disclosing the expert’s identity to the defense. The judge ruled the certificate appeared to conform with state law, and the case continued.

A year later, as both sides were getting ready to disclose their experts who would testify, Mr. Montoya again argued the neurosurgeon should be dropped from the suit. This time, he warned if the claim continued against the neurosurgeon, the defense would be filing a motion for summary judgment and pursuing attorney fees and costs. Colorado law allows for such fees if the filing or pursuit of an action is frivolous.

“Boom, my client was dismissed,” Mr. Montoya said. “This is a year later, after multiple conferences among the attorneys, multiple pleadings filed, expert witnesses retained to review the care, discovery exchanged, and records obtained. If we had [a stronger] certificate of review statute, it would have been a different ballgame. It’s never going to get a year down the road.”

In New York, physician defendants have experienced similar woes. The state’s law requires plaintiffs’ attorneys to certify that they consulted with a physician prior to filing the claim, and that they believe based on that discussion, there’s a reasonable basis for the claim to move forward. Attorneys are not required to disclose the expert’s identity.

The law also allows “an out,” explained Morris Auster, JD, senior vice president and chief legislative counsel for the Medical Society of the State of New York. If the attorney made three separate attempts to obtain a consultation, and all three experts would not agree to the consultation, the lawsuit can be filed anyway, he said.

“From our standpoint, it’s important to have an affidavit of merit requirement; it’s better than not having it,” Mr. Auster said. “But its effectiveness in providing control over the filing of lawsuits in New York has never been as strong as it could’ve been.”

Mr. Auster notes that New York has some of the highest liability costs in the country in addition to doctors paying some of the steepest medical liability insurance premiums.

“This really affects a lot of physicians and it’s driving physicians into employment arrangements, so they don’t have to deal with it on their own,” he said. “We support a number of measures to address these significantly high costs, and stronger certificate of merit requirements would certainly be one of those advocacy goals.”
 

Why are anonymous experts allowed?

Certificates of merit that shield the identity of consultants encourage a greater pool of physicians willing to review cases, said J. Matthew Dudley, JD, president of the Illinois Trial Lawyers Association. When the requirements first went into effect in Illinois, there was significant animosity among physicians toward doctors who testified in medical malpractice cases for patients, Mr. Dudley explained.

“Sometimes they would be ostracized from their professional societies, or it would hurt a referral relationship.” he said. “Over time, that animosity has lessened, but there was a concern that if the identity of physicians in certificates of merit weren’t protected, then doctors would not look at cases for patients.”

This would result in additional barriers for patients and their attorneys in pursuing their legal rights, Mr. Dudley said. He said Illinois’ certificate of merit statute is successful in fulfilling its intended purpose, and he has not seen any statistical evidence to suggest otherwise.

“It has proven effective at decreasing filings in medical malpractice and effectively screening medical malpractice cases,” he said. “Certificates of merit help to decrease filings by firms that aren’t that experienced in dealing with those kinds of cases.”

Kentucky is another state that does not require attorneys to identity the experts consulted for certificates of merit. Malpractice defense attorney Andrew DeSimone, JD, who practices in Kentucky, said this isn’t a problem since attorneys eventually must disclose the expert witnesses who will testify at trial.

“Knowing the name behind the certificate of merit is not that pertinent,” Mr. DeSimone said. “Physicians and their attorneys will ultimately have the chance to question and evaluate the expert witnesses used at trial. The certificate of merit is designed to weed out totally frivolous cases that do not have expert support. It’s not designed to be a trial on the merits.” 

The belief that plaintiffs’ attorneys frequently bring weak cases and use unqualified experts to certify claims is not realistic or logical, added Sean Domnick, JD, a Florida medical malpractice attorney and vice president for the American Association for Justice. Medical malpractice cases are extremely challenging for plaintiffs – and they’re expensive, Mr. Domnick said.  

“We can’t afford to take bad cases,” he said. “For me to take on a medical malpractice case, it’s not unusual for me to spend well over $100,000. Remember, if we lose, I don’t get that money back and I don’t get paid. Why in the world would a plaintiff take on that type of a burden for a case they didn’t believe in? The logic escapes me.”

In Florida, where Mr. Domnick practices, plaintiffs’ attorneys must send their certificates of merit to the defense with the expert identified. Domnick believes the requirement is a hindrance.

“It creates a delay that is unnecessary in a system that is already designed to wear our clients down,” he said. “It’s just another component that makes it harder on them.”
 

Hidden experts may insulate plaintiffs’ attorneys from liability

Dr. Sullivan, the Illinois emergency physician, was ultimately dismissed from the multiparty lawsuit, but not for roughly 18 months. After the dismissal, he fought back. He sued the plaintiff’s law firm for malicious prosecution, negligence in hiring, and relying on the opinion of an expert who was unqualified to render an opinion against an emergency physician.

The law firm, however, argued that it was immune from liability because it reasonably relied on the expert’s opinion as required by Illinois law. A trial court agreed with the plaintiffs’ firm. The judge denied Dr. Sullivan’s request to identify the expert, ruling there was no finding that the affidavit was untrue or made without reasonable cause. Dr. Sullivan appealed, and the appellate court upheld the trial’s court decision.

“As happened with my case, law firms can use the affidavit as a defense against countersuits or motions for sanctions,” Dr. Sullivan said. “Although the certificate of merit is intended to prevent attorneys from filing frivolous cases, it can also have the opposite effect of helping to insulate plaintiff attorneys from liability for filing a frivolous lawsuit.”

In Colorado, complaints about the state’s certificate of merit statute have gone before the Colorado Supreme Court. In one case, a lower court ruled that a certificate of merit was deficient because the consultants were not chiropractors. In another case, a nurse defendant argued the claim’s certificate of review was insufficient because the consulting expert was a physician.

In both instances, Colorado judges held the state’s statute does not require consultants to be in the same profession or the same specialty as the health professional defendant. 

In New York, meanwhile, Mr. Auster said several bills to strengthen the state’s certificate of merit requirements have failed in recent years.

“It’s hard to say whether it will improve anytime soon,” he said. “The trial lawyers are a very powerful advocacy force in the state, and they tend to oppose even the slightest of changes in civil liability. [In addition], some of these issues have been put on a lower tier because of trying to manage the pandemic.”

Ultimately, Dr. Sullivan said that courts and legislatures need to strongly consider the ethics of allowing anonymous experts to provide testimony against defendant physicians.

“I also think we need to consider how the notion of a secret expert comports with a defendant physician’s due process,” he said. “If an expert’s opinion is appropriate, why would there be a need to shroud one’s identity in a veil of secrecy?” 

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

Following a vegan diet for at least 3 months helped people with overweight or type 2 diabetes shed the pounds, but had only a marginal effect on hemoglobin A1c levels, on average, new research indicates.

No effect was seen on blood pressure, triglycerides, or high-density lipoprotein cholesterol. HbA1c was reduced by a mean of –0.18 percentage points (P = .002), and there was a small reduction in total cholesterol and low-density lipoprotein cholesterol, on average, across all the studies examined in this meta-analysis.

The work, which compared a number of trials looking at vegan diets versus “normal” eating or other kinds of weight loss diets, “indicates with reasonable certainty that adhering to a vegan diet for at least 12 weeks may result in clinically meaningful weight loss [and] can be used in the management of overweight and type 2 diabetes,” said Anne-Ditte Termannsen, PhD, who reported the findings during a press conference at the European Congress on Obesity 2022, where the work was also presented as a poster.

A vegan diet most likely led to weight loss because it is “associated with a reduced calorie intake due to a lower content of fat and higher content of dietary fiber,” added Dr. Termannsen of the Steno Diabetes Center Copenhagen.

Asked to comment, Janet Cade, PhD, who leads the Nutritional Epidemiology Group at the University of Leeds (England) said the results are likely attributable to fewer calories in the vegan diet, compared with the “control” diets. “Of course, a vegan diet can be healthier in a range of ways, such as higher fruit and vegetables, more fiber and antioxidants; however, the same would be true of a vegetarian diet,” she noted.

And she warned that longer-term data are needed on health outcomes associated with vegan diets, noting, “there have been links to poorer bone health and osteoporosis in people consuming a vegan diet.”

Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading (England) told the UK Science Media Centre: “The authors conducted a systematic review of intervention studies and found that, compared with no dietary interventions, vegan diets showed the strongest association with body-weight reduction.”

However, “When comparing vegan diets with other dietary interventions – such as the Mediterranean diet – the association was much weaker,” he noted.
 

Vegan, habitual, or a range of weight-loss diets

Dr. Termannsen and colleagues set out to look at the effect of a plant-based diet on cardiometabolic risk factors in people with overweight or type 2 diabetes. They searched the literature for randomized controlled trials with adult participants with overweight (body mass index ≥ 25 kg/m²), prediabetes, or type 2 diabetes.

Participants followed a vegan diet that lasted at least 12 weeks; habitual diets without any changes or energy restriction; a Mediterranean diet; a host of different “diabetes” diets; a low-fat diet; or portion-controlled diets.

“The vegan diets were nearly all low-fat vegan diets but vary substantially regarding the protein, fat, carbohydrate content. All but one study was ad libitum fat, and there were no energy restrictions,” Dr. Termannsen said.

Control diets were more varied. “Some continued their habitual diet, and about half were energy restricted and the others were not,” she acknowledged.

Outcomes comprised body weight, BMI, HbA1c, systolic and diastolic blood pressure, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides, which were assessed across studies.

A total of 11 trials were included in the meta-analysis, and studies were a mean duration of 19 weeks. A total of 796 participants were included.

Compared with control diets, those on vegan diets lost on average –4.1 kg (–9 lb) (P < .001), with a range of –5.9 kg to –2.4 kg.

BMI dropped by –1.38 kg/m² (P < .001). Total cholesterol dropped by –0.30 mmol/L (–11.6 mg/dL; P = .007) and LDL cholesterol by –0.24 mmol/L (–9.28 mg/dL; P = .005).

Further analyses found even greater reductions in body weight and BMI when vegan diets were compared with continuing a normal diet without dietary changes, on average, at –7.4 kg (–16.3 lb) (P < .001) and –2.78 kg/m² (P < .001) respectively.

When compared with other intervention diets, however, body weight dropped by –2.7 kg (–6 lb; P < .001) and BMI by –0.87 kg/m² (P < .001).

Commenting on limitations of studies compared to the real world, Dr. Termannsen said: “Some studies reported high adherence to their diet, usually due to a high level of support, suggesting that providing continued face-to-face contact with participants may partly explain the adherence differences.”

“This also questions the long-term feasibility of the diet and the applicability of this as long-term care,” she added.

Following a vegan diet requires good planning to ensure adequate nutrition and avoid any deficiencies, she urged. “We need to remember that the menu plans in the studies were created by dietitians.”

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

Following a vegan diet for at least 3 months helped people with overweight or type 2 diabetes shed the pounds, but had only a marginal effect on hemoglobin A1c levels, on average, new research indicates.

No effect was seen on blood pressure, triglycerides, or high-density lipoprotein cholesterol. HbA1c was reduced by a mean of –0.18 percentage points (P = .002), and there was a small reduction in total cholesterol and low-density lipoprotein cholesterol, on average, across all the studies examined in this meta-analysis.

The work, which compared a number of trials looking at vegan diets versus “normal” eating or other kinds of weight loss diets, “indicates with reasonable certainty that adhering to a vegan diet for at least 12 weeks may result in clinically meaningful weight loss [and] can be used in the management of overweight and type 2 diabetes,” said Anne-Ditte Termannsen, PhD, who reported the findings during a press conference at the European Congress on Obesity 2022, where the work was also presented as a poster.

A vegan diet most likely led to weight loss because it is “associated with a reduced calorie intake due to a lower content of fat and higher content of dietary fiber,” added Dr. Termannsen of the Steno Diabetes Center Copenhagen.

Asked to comment, Janet Cade, PhD, who leads the Nutritional Epidemiology Group at the University of Leeds (England) said the results are likely attributable to fewer calories in the vegan diet, compared with the “control” diets. “Of course, a vegan diet can be healthier in a range of ways, such as higher fruit and vegetables, more fiber and antioxidants; however, the same would be true of a vegetarian diet,” she noted.

And she warned that longer-term data are needed on health outcomes associated with vegan diets, noting, “there have been links to poorer bone health and osteoporosis in people consuming a vegan diet.”

Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading (England) told the UK Science Media Centre: “The authors conducted a systematic review of intervention studies and found that, compared with no dietary interventions, vegan diets showed the strongest association with body-weight reduction.”

However, “When comparing vegan diets with other dietary interventions – such as the Mediterranean diet – the association was much weaker,” he noted.
 

Vegan, habitual, or a range of weight-loss diets

Dr. Termannsen and colleagues set out to look at the effect of a plant-based diet on cardiometabolic risk factors in people with overweight or type 2 diabetes. They searched the literature for randomized controlled trials with adult participants with overweight (body mass index ≥ 25 kg/m²), prediabetes, or type 2 diabetes.

Participants followed a vegan diet that lasted at least 12 weeks; habitual diets without any changes or energy restriction; a Mediterranean diet; a host of different “diabetes” diets; a low-fat diet; or portion-controlled diets.

“The vegan diets were nearly all low-fat vegan diets but vary substantially regarding the protein, fat, carbohydrate content. All but one study was ad libitum fat, and there were no energy restrictions,” Dr. Termannsen said.

Control diets were more varied. “Some continued their habitual diet, and about half were energy restricted and the others were not,” she acknowledged.

Outcomes comprised body weight, BMI, HbA1c, systolic and diastolic blood pressure, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides, which were assessed across studies.

A total of 11 trials were included in the meta-analysis, and studies were a mean duration of 19 weeks. A total of 796 participants were included.

Compared with control diets, those on vegan diets lost on average –4.1 kg (–9 lb) (P < .001), with a range of –5.9 kg to –2.4 kg.

BMI dropped by –1.38 kg/m² (P < .001). Total cholesterol dropped by –0.30 mmol/L (–11.6 mg/dL; P = .007) and LDL cholesterol by –0.24 mmol/L (–9.28 mg/dL; P = .005).

Further analyses found even greater reductions in body weight and BMI when vegan diets were compared with continuing a normal diet without dietary changes, on average, at –7.4 kg (–16.3 lb) (P < .001) and –2.78 kg/m² (P < .001) respectively.

When compared with other intervention diets, however, body weight dropped by –2.7 kg (–6 lb; P < .001) and BMI by –0.87 kg/m² (P < .001).

Commenting on limitations of studies compared to the real world, Dr. Termannsen said: “Some studies reported high adherence to their diet, usually due to a high level of support, suggesting that providing continued face-to-face contact with participants may partly explain the adherence differences.”

“This also questions the long-term feasibility of the diet and the applicability of this as long-term care,” she added.

Following a vegan diet requires good planning to ensure adequate nutrition and avoid any deficiencies, she urged. “We need to remember that the menu plans in the studies were created by dietitians.”

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

Following a vegan diet for at least 3 months helped people with overweight or type 2 diabetes shed the pounds, but had only a marginal effect on hemoglobin A1c levels, on average, new research indicates.

No effect was seen on blood pressure, triglycerides, or high-density lipoprotein cholesterol. HbA1c was reduced by a mean of –0.18 percentage points (P = .002), and there was a small reduction in total cholesterol and low-density lipoprotein cholesterol, on average, across all the studies examined in this meta-analysis.

The work, which compared a number of trials looking at vegan diets versus “normal” eating or other kinds of weight loss diets, “indicates with reasonable certainty that adhering to a vegan diet for at least 12 weeks may result in clinically meaningful weight loss [and] can be used in the management of overweight and type 2 diabetes,” said Anne-Ditte Termannsen, PhD, who reported the findings during a press conference at the European Congress on Obesity 2022, where the work was also presented as a poster.

A vegan diet most likely led to weight loss because it is “associated with a reduced calorie intake due to a lower content of fat and higher content of dietary fiber,” added Dr. Termannsen of the Steno Diabetes Center Copenhagen.

Asked to comment, Janet Cade, PhD, who leads the Nutritional Epidemiology Group at the University of Leeds (England) said the results are likely attributable to fewer calories in the vegan diet, compared with the “control” diets. “Of course, a vegan diet can be healthier in a range of ways, such as higher fruit and vegetables, more fiber and antioxidants; however, the same would be true of a vegetarian diet,” she noted.

And she warned that longer-term data are needed on health outcomes associated with vegan diets, noting, “there have been links to poorer bone health and osteoporosis in people consuming a vegan diet.”

Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading (England) told the UK Science Media Centre: “The authors conducted a systematic review of intervention studies and found that, compared with no dietary interventions, vegan diets showed the strongest association with body-weight reduction.”

However, “When comparing vegan diets with other dietary interventions – such as the Mediterranean diet – the association was much weaker,” he noted.
 

Vegan, habitual, or a range of weight-loss diets

Dr. Termannsen and colleagues set out to look at the effect of a plant-based diet on cardiometabolic risk factors in people with overweight or type 2 diabetes. They searched the literature for randomized controlled trials with adult participants with overweight (body mass index ≥ 25 kg/m²), prediabetes, or type 2 diabetes.

Participants followed a vegan diet that lasted at least 12 weeks; habitual diets without any changes or energy restriction; a Mediterranean diet; a host of different “diabetes” diets; a low-fat diet; or portion-controlled diets.

“The vegan diets were nearly all low-fat vegan diets but vary substantially regarding the protein, fat, carbohydrate content. All but one study was ad libitum fat, and there were no energy restrictions,” Dr. Termannsen said.

Control diets were more varied. “Some continued their habitual diet, and about half were energy restricted and the others were not,” she acknowledged.

Outcomes comprised body weight, BMI, HbA1c, systolic and diastolic blood pressure, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides, which were assessed across studies.

A total of 11 trials were included in the meta-analysis, and studies were a mean duration of 19 weeks. A total of 796 participants were included.

Compared with control diets, those on vegan diets lost on average –4.1 kg (–9 lb) (P < .001), with a range of –5.9 kg to –2.4 kg.

BMI dropped by –1.38 kg/m² (P < .001). Total cholesterol dropped by –0.30 mmol/L (–11.6 mg/dL; P = .007) and LDL cholesterol by –0.24 mmol/L (–9.28 mg/dL; P = .005).

Further analyses found even greater reductions in body weight and BMI when vegan diets were compared with continuing a normal diet without dietary changes, on average, at –7.4 kg (–16.3 lb) (P < .001) and –2.78 kg/m² (P < .001) respectively.

When compared with other intervention diets, however, body weight dropped by –2.7 kg (–6 lb; P < .001) and BMI by –0.87 kg/m² (P < .001).

Commenting on limitations of studies compared to the real world, Dr. Termannsen said: “Some studies reported high adherence to their diet, usually due to a high level of support, suggesting that providing continued face-to-face contact with participants may partly explain the adherence differences.”

“This also questions the long-term feasibility of the diet and the applicability of this as long-term care,” she added.

Following a vegan diet requires good planning to ensure adequate nutrition and avoid any deficiencies, she urged. “We need to remember that the menu plans in the studies were created by dietitians.”

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

Stanford Health Care’s resident physicians voted May 2 in favor of joining the Committee of Interns and Residents (CIR-SEIU), part of a growing trend in unionization within the medical profession.

More than 81% of the health system’s resident physicians voted to join the union; the decision garnered 835 yes votes and 214 no votes, according to a CIR-SEIU announcement. The largest housestaff union in the United States and a local of the Service Employees International Union (SEIU), CIR-SEIU represents more than 20,000 resident physicians and fellows.

“With its successful representation with the Committee of Interns and Residents, Stanford housestaff now join the strong community of allied unions and fellow health care workers such as the Committee for Recognition of Nursing Achievement (CRONA), an independent union of Stanford nurses,” according to CIR-SEIU.

“We are organizing not only for a new economic contract that enables all potential housestaff and their families to afford living in the Bay Area but also for a new social contract that redefines how we are valued by the hospital system,” Ben Solomon, MD, PhD, a third-year resident physician in pediatrics at Stanford Medicine and a member of CIR-SEIU, said in an interview.

“This includes advocating for more humane working hours, reasonable parental leave, and childcare support, as well as resources to combat burnout in young physicians,” he added.

Lisa Kim, a spokesperson for Stanford Health Care, told this news organization that “a majority of residents and fellows at Stanford Health Care voted in favor of unionization. Of 1,478 total residents and fellows, 835 voted in favor. CIR/SEIU will be certified as the exclusive bargaining representative for all residents and fellows. Stanford Health Care does not plan to contest the election results.”

“As we begin the collective bargaining process, our goal remains unchanged: providing our residents and fellows with a world-class training experience. We will bring this same focus to negotiations as we strive to support their development as physician leaders,” she added.

The National Labor Relations Board (NLRB) must certify the election results before they are considered final, per CIR-SEIU. An independent federal agency, the NLRB safeguards employees’ rights to organize and determines whether union participation is appropriate while also preventing and remedying unfair labor practices committed by private sector employers and unions.
 

Concerns date back to initial COVID-19 vaccine rollout

The residents delivered a formal demand to Stanford Health Care to recognize the union in February; their request was not accepted by the health system. The residents’ concerns date as far back as the availability of the COVID-19 vaccines at the end of 2020.

Of the health system’s 5,000 doses, only seven residents and fellows were included in the initial round.

Niraj Sehgal, MD, chief medical officer for Stanford Health Care, apologized in a letter to the graduate medical education community, posted by Palo Alto Weekly, which revealed the root causes to be an algorithm used by the hospital and the age of the residents.

The vote by Stanford Health Care’s residents comes a day after nurses at Stanford and Lucile Packard Children’s hospitals ratified a new contract with their union after a strike for better working conditions and higher pay stretched on for a week, reported Palo Alto Online.
 

Part of a growing trend

Dr. Solomon got involved in the unionization effort at Stanford Health Care “to have a say in working conditions for residents and fellows,” he said. “As individuals, it’s virtually impossible to make demands to our hospital without risking our careers, but together we can demand improvements on the job and in patient care.”

The health system’s inability to extend COVID-19 vaccines during the initial rollout, “despite our role working with COVID patients on the frontlines,” spurred his involvement in the union effort, said Dr. Solomon.

In the short term, the union will be involved in negotiating its first contract, he said. “However, in the long term, we are committed to supporting the unionization efforts of residents and fellows across the country, including partnering with many housestaff unions here in California.”

Stanford Health Care’s residents are participating in a growing trend. In Worcester, Mass., UMass Medical School’s 613 residents and fellow physicians, who are also represented by CIR-SEIU, had their union certified by the Massachusetts Department of Labor Relations in March 2021, reported the (Worcester) Telegram & Gazette.

Other unionization efforts across the country include a supermajority of 85 interns, residents, and fellows employed by Keck School of Medicine of University of Southern California , who requested that Los Angeles County+USC Medical Center recognize their union, per an announcement. That’s in addition to residents at University of Vermont Medical Center, who announced their intention to unionize in March, reported VTDigger.org.

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

Stanford Health Care’s resident physicians voted May 2 in favor of joining the Committee of Interns and Residents (CIR-SEIU), part of a growing trend in unionization within the medical profession.

More than 81% of the health system’s resident physicians voted to join the union; the decision garnered 835 yes votes and 214 no votes, according to a CIR-SEIU announcement. The largest housestaff union in the United States and a local of the Service Employees International Union (SEIU), CIR-SEIU represents more than 20,000 resident physicians and fellows.

“With its successful representation with the Committee of Interns and Residents, Stanford housestaff now join the strong community of allied unions and fellow health care workers such as the Committee for Recognition of Nursing Achievement (CRONA), an independent union of Stanford nurses,” according to CIR-SEIU.

“We are organizing not only for a new economic contract that enables all potential housestaff and their families to afford living in the Bay Area but also for a new social contract that redefines how we are valued by the hospital system,” Ben Solomon, MD, PhD, a third-year resident physician in pediatrics at Stanford Medicine and a member of CIR-SEIU, said in an interview.

“This includes advocating for more humane working hours, reasonable parental leave, and childcare support, as well as resources to combat burnout in young physicians,” he added.

Lisa Kim, a spokesperson for Stanford Health Care, told this news organization that “a majority of residents and fellows at Stanford Health Care voted in favor of unionization. Of 1,478 total residents and fellows, 835 voted in favor. CIR/SEIU will be certified as the exclusive bargaining representative for all residents and fellows. Stanford Health Care does not plan to contest the election results.”

“As we begin the collective bargaining process, our goal remains unchanged: providing our residents and fellows with a world-class training experience. We will bring this same focus to negotiations as we strive to support their development as physician leaders,” she added.

The National Labor Relations Board (NLRB) must certify the election results before they are considered final, per CIR-SEIU. An independent federal agency, the NLRB safeguards employees’ rights to organize and determines whether union participation is appropriate while also preventing and remedying unfair labor practices committed by private sector employers and unions.
 

Concerns date back to initial COVID-19 vaccine rollout

The residents delivered a formal demand to Stanford Health Care to recognize the union in February; their request was not accepted by the health system. The residents’ concerns date as far back as the availability of the COVID-19 vaccines at the end of 2020.

Of the health system’s 5,000 doses, only seven residents and fellows were included in the initial round.

Niraj Sehgal, MD, chief medical officer for Stanford Health Care, apologized in a letter to the graduate medical education community, posted by Palo Alto Weekly, which revealed the root causes to be an algorithm used by the hospital and the age of the residents.

The vote by Stanford Health Care’s residents comes a day after nurses at Stanford and Lucile Packard Children’s hospitals ratified a new contract with their union after a strike for better working conditions and higher pay stretched on for a week, reported Palo Alto Online.
 

Part of a growing trend

Dr. Solomon got involved in the unionization effort at Stanford Health Care “to have a say in working conditions for residents and fellows,” he said. “As individuals, it’s virtually impossible to make demands to our hospital without risking our careers, but together we can demand improvements on the job and in patient care.”

The health system’s inability to extend COVID-19 vaccines during the initial rollout, “despite our role working with COVID patients on the frontlines,” spurred his involvement in the union effort, said Dr. Solomon.

In the short term, the union will be involved in negotiating its first contract, he said. “However, in the long term, we are committed to supporting the unionization efforts of residents and fellows across the country, including partnering with many housestaff unions here in California.”

Stanford Health Care’s residents are participating in a growing trend. In Worcester, Mass., UMass Medical School’s 613 residents and fellow physicians, who are also represented by CIR-SEIU, had their union certified by the Massachusetts Department of Labor Relations in March 2021, reported the (Worcester) Telegram & Gazette.

Other unionization efforts across the country include a supermajority of 85 interns, residents, and fellows employed by Keck School of Medicine of University of Southern California , who requested that Los Angeles County+USC Medical Center recognize their union, per an announcement. That’s in addition to residents at University of Vermont Medical Center, who announced their intention to unionize in March, reported VTDigger.org.

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

Stanford Health Care’s resident physicians voted May 2 in favor of joining the Committee of Interns and Residents (CIR-SEIU), part of a growing trend in unionization within the medical profession.

More than 81% of the health system’s resident physicians voted to join the union; the decision garnered 835 yes votes and 214 no votes, according to a CIR-SEIU announcement. The largest housestaff union in the United States and a local of the Service Employees International Union (SEIU), CIR-SEIU represents more than 20,000 resident physicians and fellows.

“With its successful representation with the Committee of Interns and Residents, Stanford housestaff now join the strong community of allied unions and fellow health care workers such as the Committee for Recognition of Nursing Achievement (CRONA), an independent union of Stanford nurses,” according to CIR-SEIU.

“We are organizing not only for a new economic contract that enables all potential housestaff and their families to afford living in the Bay Area but also for a new social contract that redefines how we are valued by the hospital system,” Ben Solomon, MD, PhD, a third-year resident physician in pediatrics at Stanford Medicine and a member of CIR-SEIU, said in an interview.

“This includes advocating for more humane working hours, reasonable parental leave, and childcare support, as well as resources to combat burnout in young physicians,” he added.

Lisa Kim, a spokesperson for Stanford Health Care, told this news organization that “a majority of residents and fellows at Stanford Health Care voted in favor of unionization. Of 1,478 total residents and fellows, 835 voted in favor. CIR/SEIU will be certified as the exclusive bargaining representative for all residents and fellows. Stanford Health Care does not plan to contest the election results.”

“As we begin the collective bargaining process, our goal remains unchanged: providing our residents and fellows with a world-class training experience. We will bring this same focus to negotiations as we strive to support their development as physician leaders,” she added.

The National Labor Relations Board (NLRB) must certify the election results before they are considered final, per CIR-SEIU. An independent federal agency, the NLRB safeguards employees’ rights to organize and determines whether union participation is appropriate while also preventing and remedying unfair labor practices committed by private sector employers and unions.
 

Concerns date back to initial COVID-19 vaccine rollout

The residents delivered a formal demand to Stanford Health Care to recognize the union in February; their request was not accepted by the health system. The residents’ concerns date as far back as the availability of the COVID-19 vaccines at the end of 2020.

Of the health system’s 5,000 doses, only seven residents and fellows were included in the initial round.

Niraj Sehgal, MD, chief medical officer for Stanford Health Care, apologized in a letter to the graduate medical education community, posted by Palo Alto Weekly, which revealed the root causes to be an algorithm used by the hospital and the age of the residents.

The vote by Stanford Health Care’s residents comes a day after nurses at Stanford and Lucile Packard Children’s hospitals ratified a new contract with their union after a strike for better working conditions and higher pay stretched on for a week, reported Palo Alto Online.
 

Part of a growing trend

Dr. Solomon got involved in the unionization effort at Stanford Health Care “to have a say in working conditions for residents and fellows,” he said. “As individuals, it’s virtually impossible to make demands to our hospital without risking our careers, but together we can demand improvements on the job and in patient care.”

The health system’s inability to extend COVID-19 vaccines during the initial rollout, “despite our role working with COVID patients on the frontlines,” spurred his involvement in the union effort, said Dr. Solomon.

In the short term, the union will be involved in negotiating its first contract, he said. “However, in the long term, we are committed to supporting the unionization efforts of residents and fellows across the country, including partnering with many housestaff unions here in California.”

Stanford Health Care’s residents are participating in a growing trend. In Worcester, Mass., UMass Medical School’s 613 residents and fellow physicians, who are also represented by CIR-SEIU, had their union certified by the Massachusetts Department of Labor Relations in March 2021, reported the (Worcester) Telegram & Gazette.

Other unionization efforts across the country include a supermajority of 85 interns, residents, and fellows employed by Keck School of Medicine of University of Southern California , who requested that Los Angeles County+USC Medical Center recognize their union, per an announcement. That’s in addition to residents at University of Vermont Medical Center, who announced their intention to unionize in March, reported VTDigger.org.

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

The Food and Drug Administration is limiting who can receive the Johnson & Johnson COVID-19 vaccine because of concerns about the risk of a rare blood clotting condition.

In a statement issued May 5, the FDA said the J&J vaccine should only be given to people 18 and older who don’t have access to other vaccines or for whom other vaccines are not clinically appropriate. People 18 and older can also get the J&J vaccine if they choose to because they wouldn’t otherwise receive any vaccine, the FDA said.

The FDA statement was similar to the recommendation made in December by a Centers for Disease Control and Prevention committee of experts.

The FDA said the decision was made after more information was shared about the occurrence of a rare blood clotting condition, thrombosis with thrombocytopenia syndrome (TTS), 1 or 2 weeks after people received the J&J vaccine. The finding “warrants limiting the authorized use of the vaccine,” the FDA said.

“We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.

“Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”

The CDC says 16.9 million people are fully vaccinated with the J&J vaccine, compared with 76.5 million with Moderna and 126.3 million with Pfizer.

Through March 18, the CDC and FDA have detected 60 confirmed cases of TTS, including 9 fatal cases, ABC News reported.

The J&J vaccine was granted emergency authorization in February 2021. Health authorities hoped it would help spread vaccines across the nation because it only required one initial dose and didn’t need to be stored at extremely cold temperatures, unlike the two-dose Pfizer and Moderna vaccines.

But 2 months after authorization, the government paused its use for 10 days because of reports of TTS. In December 2021, the CDC’s Advisory Committee on Immunization Practices said the Pfizer and Moderna vaccines were preferred over J&J because J&J carried the rare risk of blood clots and bleeding in the brain.

The FDA said the cause of the blood clotting is not known. But the “known and potential benefits of the vaccine” outweigh the risks for those people now allowed to receive it, the FDA said.

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

The Food and Drug Administration is limiting who can receive the Johnson & Johnson COVID-19 vaccine because of concerns about the risk of a rare blood clotting condition.

In a statement issued May 5, the FDA said the J&J vaccine should only be given to people 18 and older who don’t have access to other vaccines or for whom other vaccines are not clinically appropriate. People 18 and older can also get the J&J vaccine if they choose to because they wouldn’t otherwise receive any vaccine, the FDA said.

The FDA statement was similar to the recommendation made in December by a Centers for Disease Control and Prevention committee of experts.

The FDA said the decision was made after more information was shared about the occurrence of a rare blood clotting condition, thrombosis with thrombocytopenia syndrome (TTS), 1 or 2 weeks after people received the J&J vaccine. The finding “warrants limiting the authorized use of the vaccine,” the FDA said.

“We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.

“Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”

The CDC says 16.9 million people are fully vaccinated with the J&J vaccine, compared with 76.5 million with Moderna and 126.3 million with Pfizer.

Through March 18, the CDC and FDA have detected 60 confirmed cases of TTS, including 9 fatal cases, ABC News reported.

The J&J vaccine was granted emergency authorization in February 2021. Health authorities hoped it would help spread vaccines across the nation because it only required one initial dose and didn’t need to be stored at extremely cold temperatures, unlike the two-dose Pfizer and Moderna vaccines.

But 2 months after authorization, the government paused its use for 10 days because of reports of TTS. In December 2021, the CDC’s Advisory Committee on Immunization Practices said the Pfizer and Moderna vaccines were preferred over J&J because J&J carried the rare risk of blood clots and bleeding in the brain.

The FDA said the cause of the blood clotting is not known. But the “known and potential benefits of the vaccine” outweigh the risks for those people now allowed to receive it, the FDA said.

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

The Food and Drug Administration is limiting who can receive the Johnson & Johnson COVID-19 vaccine because of concerns about the risk of a rare blood clotting condition.

In a statement issued May 5, the FDA said the J&J vaccine should only be given to people 18 and older who don’t have access to other vaccines or for whom other vaccines are not clinically appropriate. People 18 and older can also get the J&J vaccine if they choose to because they wouldn’t otherwise receive any vaccine, the FDA said.

The FDA statement was similar to the recommendation made in December by a Centers for Disease Control and Prevention committee of experts.

The FDA said the decision was made after more information was shared about the occurrence of a rare blood clotting condition, thrombosis with thrombocytopenia syndrome (TTS), 1 or 2 weeks after people received the J&J vaccine. The finding “warrants limiting the authorized use of the vaccine,” the FDA said.

“We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.

“Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”

The CDC says 16.9 million people are fully vaccinated with the J&J vaccine, compared with 76.5 million with Moderna and 126.3 million with Pfizer.

Through March 18, the CDC and FDA have detected 60 confirmed cases of TTS, including 9 fatal cases, ABC News reported.

The J&J vaccine was granted emergency authorization in February 2021. Health authorities hoped it would help spread vaccines across the nation because it only required one initial dose and didn’t need to be stored at extremely cold temperatures, unlike the two-dose Pfizer and Moderna vaccines.

But 2 months after authorization, the government paused its use for 10 days because of reports of TTS. In December 2021, the CDC’s Advisory Committee on Immunization Practices said the Pfizer and Moderna vaccines were preferred over J&J because J&J carried the rare risk of blood clots and bleeding in the brain.

The FDA said the cause of the blood clotting is not known. But the “known and potential benefits of the vaccine” outweigh the risks for those people now allowed to receive it, the FDA said.

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

Signs of cardiometabolic damage in children who are overweight appear as early as 6-8 years of age, but were not evident in preschoolers, providing a window of opportunity for intervention, show the latest results from a long-running Danish study of childhood weight.

The proportion of children who were overweight (nearly 14% in 2015) was similar between the two groups – those of preschool age (2-5 years) and school age (6-8 years) – but only the latter showed significant signs of cardiometabolic abnormalities.

The results, published in Obesity Research & Clinical Practice, are the latest in a series of many findings from the HOLBAEK study (formerly known as The Danish Childhood Obesity Biobank) that have emerged since it began in 2007. They were presented, along with a meta-analysis of much of their work, at the European Congress on Obesity (ECO) 2022.

“When comparing children with and without overweight, there were only barely significant differences among the preschool children,” said investigator Christine Frithioff-Bøjsøe, MD, but in contrast, “the school children with overweight exhibited significantly higher systolic blood pressure, glucose, insulin, and higher HDL cholesterol,” among other markers, she noted.

“Detection needs to start as early as age 2-5 years because if you wait just a few years longer these children will show early signs of disease starting to take hold. This could provide a critical window to detect and manage overweight,” said Frithioff-Bøjsøe, PhD, of the Children’s Obesity Clinic, Copenhagen University, Hospital Holbaek, Denmark.

Asked to comment, Aaron S. Kelly, PhD, professor of pediatrics, codirector, University of Minnesota Center for Pediatric Obesity Medicine in Minneapolis, said: “Recent results from HOLBAEK highlight the critical importance of identifying obesity early in life, before its complications spring up.

“Ideally, we should be in the business of managing and reducing excess adiposity as soon as it surfaces with the goal of preventing the onset of cardiometabolic risk factors, not watchful waiting and hoping for the best.”
 

Routine dental visits checked overweight

In the newest study, the researchers trained dental assistants to measure weight and height and carried out body mass index assessments during routine appointments.

A total of 335 preschool and 657 school-age children were recruited for the study. Of these, 40% attended additional hospital-based examinations including blood pressure measurement and a blood sample. Children were reexamined approximately 1 year later.

Systolic blood pressure, for example, was significantly higher in 6- to 8-year-olds with overweight compared to those of normal weight (P = .001). There was no significant difference between systolic blood pressure of 2.5- to 5-year-olds without and with overweight.

Likewise, with insulin resistance, there was no significant difference between preschoolers with and without overweight. However, in schoolchildren, homoeostasis model of assessment–insulin resistance (HOMA-IR) was significantly higher in those with overweight, at 2.2, compared to those without, at 0.9 (P < .001).

Also, during follow-up (around a year later), the prevalence of overweight did not change in preschool children but increased from 13.7% to 17.0% in schoolchildren.

The researchers noted that, in Europe, it is the primary health care sector that has continuous contact with the pediatric population, with the potential for early evaluation of children at risk. Their decision to use dental health care assistants to assess weight in this particular study is novel, but feasible, they observed.
 

Danish model for treating overweight and obesity is ‘game-changing’

As part of the HOLBAEK initiative, clinical data and biological samples have been collected from children and adolescents receiving treatment at The Children’s Obesity Clinic, Holbaek Hospital, using a population-based cohort as a reference group. Data have been collected on about 8,000 children and adolescents so far.

Jens-Christian Holm, PhD, along with colleague and research assistant Maria Frauland, both from Copenhagen University, Hospital Holbaek, presented a review of the HOLBAEK studies (2007-2021) at ECO 2022. They said the results highlight the importance of taking an integrated approach to managing children and adolescents with obesity.

The review, which included 82 papers, found a wide variety of obesity-related complications already present at a young age in some of the cross-sectional studies, including dyslipidemia in 28% of children with obesity, hepatic steatosis in 31%, obstructive sleep apnea in 45%, and prehypertension or hypertension in 52%.

The family-based interventional weight management programs adopted by HOLBAEK showed a 75% reduction in the “degree of obesity,” which comprised a measure of dyslipidemia, hypertension, hepatic steatosis, sleep apnea, and parental obesity.

“The HOLBAEK method is a holistic approach where we integrate everything,” Dr. Holm told this news organization.

Ms. Frauland said: “The HOLBAEK study has provided important insights into childhood overweight. It has highlighted that obesity is a serious multisystem disease that can be managed and treated effectively, reducing the degree of overweight and improving overweight-related complications.”

Dr. Kelly, the U.S. pediatrician, applauded the HOLBAEK philosophy, which emphasizes that obesity is not the fault of the child or parent, but rather the manifestation of dysregulated energy metabolism. “The recognition that obesity is a biologically driven, chronic, refractory, and relapsing disease is interwoven into the approach, which shifts the responsibility to the care provider for ensuring positive outcomes of treatment.

“Highlighting this fact to the parents and child can be game-changing since it removes the blame and shame associated with obesity and unburdens the family by framing the problem in a different light,” Dr. Kelly stressed.

Dr. Frithioff-Bøjsøe has reported no relevant financial relationships. Dr. Holm has an obesity management company called Holm. Dr. Kelly serves as an unpaid consultant for Novo Nordisk, Vivus, Eli Lilly, and Boehringer Ingelheim and receives donated drug/placebo from Vivus for a clinical trial funded by the National Institutes of Health.

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

Signs of cardiometabolic damage in children who are overweight appear as early as 6-8 years of age, but were not evident in preschoolers, providing a window of opportunity for intervention, show the latest results from a long-running Danish study of childhood weight.

The proportion of children who were overweight (nearly 14% in 2015) was similar between the two groups – those of preschool age (2-5 years) and school age (6-8 years) – but only the latter showed significant signs of cardiometabolic abnormalities.

The results, published in Obesity Research & Clinical Practice, are the latest in a series of many findings from the HOLBAEK study (formerly known as The Danish Childhood Obesity Biobank) that have emerged since it began in 2007. They were presented, along with a meta-analysis of much of their work, at the European Congress on Obesity (ECO) 2022.

“When comparing children with and without overweight, there were only barely significant differences among the preschool children,” said investigator Christine Frithioff-Bøjsøe, MD, but in contrast, “the school children with overweight exhibited significantly higher systolic blood pressure, glucose, insulin, and higher HDL cholesterol,” among other markers, she noted.

“Detection needs to start as early as age 2-5 years because if you wait just a few years longer these children will show early signs of disease starting to take hold. This could provide a critical window to detect and manage overweight,” said Frithioff-Bøjsøe, PhD, of the Children’s Obesity Clinic, Copenhagen University, Hospital Holbaek, Denmark.

Asked to comment, Aaron S. Kelly, PhD, professor of pediatrics, codirector, University of Minnesota Center for Pediatric Obesity Medicine in Minneapolis, said: “Recent results from HOLBAEK highlight the critical importance of identifying obesity early in life, before its complications spring up.

“Ideally, we should be in the business of managing and reducing excess adiposity as soon as it surfaces with the goal of preventing the onset of cardiometabolic risk factors, not watchful waiting and hoping for the best.”
 

Routine dental visits checked overweight

In the newest study, the researchers trained dental assistants to measure weight and height and carried out body mass index assessments during routine appointments.

A total of 335 preschool and 657 school-age children were recruited for the study. Of these, 40% attended additional hospital-based examinations including blood pressure measurement and a blood sample. Children were reexamined approximately 1 year later.

Systolic blood pressure, for example, was significantly higher in 6- to 8-year-olds with overweight compared to those of normal weight (P = .001). There was no significant difference between systolic blood pressure of 2.5- to 5-year-olds without and with overweight.

Likewise, with insulin resistance, there was no significant difference between preschoolers with and without overweight. However, in schoolchildren, homoeostasis model of assessment–insulin resistance (HOMA-IR) was significantly higher in those with overweight, at 2.2, compared to those without, at 0.9 (P < .001).

Also, during follow-up (around a year later), the prevalence of overweight did not change in preschool children but increased from 13.7% to 17.0% in schoolchildren.

The researchers noted that, in Europe, it is the primary health care sector that has continuous contact with the pediatric population, with the potential for early evaluation of children at risk. Their decision to use dental health care assistants to assess weight in this particular study is novel, but feasible, they observed.
 

Danish model for treating overweight and obesity is ‘game-changing’

As part of the HOLBAEK initiative, clinical data and biological samples have been collected from children and adolescents receiving treatment at The Children’s Obesity Clinic, Holbaek Hospital, using a population-based cohort as a reference group. Data have been collected on about 8,000 children and adolescents so far.

Jens-Christian Holm, PhD, along with colleague and research assistant Maria Frauland, both from Copenhagen University, Hospital Holbaek, presented a review of the HOLBAEK studies (2007-2021) at ECO 2022. They said the results highlight the importance of taking an integrated approach to managing children and adolescents with obesity.

The review, which included 82 papers, found a wide variety of obesity-related complications already present at a young age in some of the cross-sectional studies, including dyslipidemia in 28% of children with obesity, hepatic steatosis in 31%, obstructive sleep apnea in 45%, and prehypertension or hypertension in 52%.

The family-based interventional weight management programs adopted by HOLBAEK showed a 75% reduction in the “degree of obesity,” which comprised a measure of dyslipidemia, hypertension, hepatic steatosis, sleep apnea, and parental obesity.

“The HOLBAEK method is a holistic approach where we integrate everything,” Dr. Holm told this news organization.

Ms. Frauland said: “The HOLBAEK study has provided important insights into childhood overweight. It has highlighted that obesity is a serious multisystem disease that can be managed and treated effectively, reducing the degree of overweight and improving overweight-related complications.”

Dr. Kelly, the U.S. pediatrician, applauded the HOLBAEK philosophy, which emphasizes that obesity is not the fault of the child or parent, but rather the manifestation of dysregulated energy metabolism. “The recognition that obesity is a biologically driven, chronic, refractory, and relapsing disease is interwoven into the approach, which shifts the responsibility to the care provider for ensuring positive outcomes of treatment.

“Highlighting this fact to the parents and child can be game-changing since it removes the blame and shame associated with obesity and unburdens the family by framing the problem in a different light,” Dr. Kelly stressed.

Dr. Frithioff-Bøjsøe has reported no relevant financial relationships. Dr. Holm has an obesity management company called Holm. Dr. Kelly serves as an unpaid consultant for Novo Nordisk, Vivus, Eli Lilly, and Boehringer Ingelheim and receives donated drug/placebo from Vivus for a clinical trial funded by the National Institutes of Health.

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

Signs of cardiometabolic damage in children who are overweight appear as early as 6-8 years of age, but were not evident in preschoolers, providing a window of opportunity for intervention, show the latest results from a long-running Danish study of childhood weight.

The proportion of children who were overweight (nearly 14% in 2015) was similar between the two groups – those of preschool age (2-5 years) and school age (6-8 years) – but only the latter showed significant signs of cardiometabolic abnormalities.

The results, published in Obesity Research & Clinical Practice, are the latest in a series of many findings from the HOLBAEK study (formerly known as The Danish Childhood Obesity Biobank) that have emerged since it began in 2007. They were presented, along with a meta-analysis of much of their work, at the European Congress on Obesity (ECO) 2022.

“When comparing children with and without overweight, there were only barely significant differences among the preschool children,” said investigator Christine Frithioff-Bøjsøe, MD, but in contrast, “the school children with overweight exhibited significantly higher systolic blood pressure, glucose, insulin, and higher HDL cholesterol,” among other markers, she noted.

“Detection needs to start as early as age 2-5 years because if you wait just a few years longer these children will show early signs of disease starting to take hold. This could provide a critical window to detect and manage overweight,” said Frithioff-Bøjsøe, PhD, of the Children’s Obesity Clinic, Copenhagen University, Hospital Holbaek, Denmark.

Asked to comment, Aaron S. Kelly, PhD, professor of pediatrics, codirector, University of Minnesota Center for Pediatric Obesity Medicine in Minneapolis, said: “Recent results from HOLBAEK highlight the critical importance of identifying obesity early in life, before its complications spring up.

“Ideally, we should be in the business of managing and reducing excess adiposity as soon as it surfaces with the goal of preventing the onset of cardiometabolic risk factors, not watchful waiting and hoping for the best.”
 

Routine dental visits checked overweight

In the newest study, the researchers trained dental assistants to measure weight and height and carried out body mass index assessments during routine appointments.

A total of 335 preschool and 657 school-age children were recruited for the study. Of these, 40% attended additional hospital-based examinations including blood pressure measurement and a blood sample. Children were reexamined approximately 1 year later.

Systolic blood pressure, for example, was significantly higher in 6- to 8-year-olds with overweight compared to those of normal weight (P = .001). There was no significant difference between systolic blood pressure of 2.5- to 5-year-olds without and with overweight.

Likewise, with insulin resistance, there was no significant difference between preschoolers with and without overweight. However, in schoolchildren, homoeostasis model of assessment–insulin resistance (HOMA-IR) was significantly higher in those with overweight, at 2.2, compared to those without, at 0.9 (P < .001).

Also, during follow-up (around a year later), the prevalence of overweight did not change in preschool children but increased from 13.7% to 17.0% in schoolchildren.

The researchers noted that, in Europe, it is the primary health care sector that has continuous contact with the pediatric population, with the potential for early evaluation of children at risk. Their decision to use dental health care assistants to assess weight in this particular study is novel, but feasible, they observed.
 

Danish model for treating overweight and obesity is ‘game-changing’

As part of the HOLBAEK initiative, clinical data and biological samples have been collected from children and adolescents receiving treatment at The Children’s Obesity Clinic, Holbaek Hospital, using a population-based cohort as a reference group. Data have been collected on about 8,000 children and adolescents so far.

Jens-Christian Holm, PhD, along with colleague and research assistant Maria Frauland, both from Copenhagen University, Hospital Holbaek, presented a review of the HOLBAEK studies (2007-2021) at ECO 2022. They said the results highlight the importance of taking an integrated approach to managing children and adolescents with obesity.

The review, which included 82 papers, found a wide variety of obesity-related complications already present at a young age in some of the cross-sectional studies, including dyslipidemia in 28% of children with obesity, hepatic steatosis in 31%, obstructive sleep apnea in 45%, and prehypertension or hypertension in 52%.

The family-based interventional weight management programs adopted by HOLBAEK showed a 75% reduction in the “degree of obesity,” which comprised a measure of dyslipidemia, hypertension, hepatic steatosis, sleep apnea, and parental obesity.

“The HOLBAEK method is a holistic approach where we integrate everything,” Dr. Holm told this news organization.

Ms. Frauland said: “The HOLBAEK study has provided important insights into childhood overweight. It has highlighted that obesity is a serious multisystem disease that can be managed and treated effectively, reducing the degree of overweight and improving overweight-related complications.”

Dr. Kelly, the U.S. pediatrician, applauded the HOLBAEK philosophy, which emphasizes that obesity is not the fault of the child or parent, but rather the manifestation of dysregulated energy metabolism. “The recognition that obesity is a biologically driven, chronic, refractory, and relapsing disease is interwoven into the approach, which shifts the responsibility to the care provider for ensuring positive outcomes of treatment.

“Highlighting this fact to the parents and child can be game-changing since it removes the blame and shame associated with obesity and unburdens the family by framing the problem in a different light,” Dr. Kelly stressed.

Dr. Frithioff-Bøjsøe has reported no relevant financial relationships. Dr. Holm has an obesity management company called Holm. Dr. Kelly serves as an unpaid consultant for Novo Nordisk, Vivus, Eli Lilly, and Boehringer Ingelheim and receives donated drug/placebo from Vivus for a clinical trial funded by the National Institutes of Health.

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

CHICAGO – Both physicians and patients like the idea of having health care delivered virtually, and telehealth will likely continue to be prominent in the U.S. medical landscape, according to the medical director for digital health and telemedicine at Johns Hopkins Medicine, Baltimore.

This physician, Brian Hasselfeld, MD, said his university’s health system did 50-80 telemedicine visits a month before COVID, during a presentation at the annual meeting of the American College of Physicians. This soared to close to 100,000 a month in the pandemic, and now the health system does close to 40,000 a month, he continued.

“Life is definitely different in how we engage with our patients on a day-to-day basis,” said Dr. Hasselfeld, who oversees the telehealth for six hospitals and 50 ambulatory-care locations in Maryland and three other states.

Attitudes gauged in Johns Hopkins surveys suggest that a lot of medical care will continue to be provided by telemedicine. Nine out of 10 patients said they would likely recommend telemedicine to friends and family, and 88% said it would be either moderately, very, or extremely important to have video visit options in the future, he said.

A survey of the Hopkins system’s 3,600 physicians, which generated about 1,300 responses, found that physicians would like to have a considerable chunk of time set aside for telemedicine visits – the median response was 30%.
 

Virtual care is in ‘early-adopter phase’

But Dr. Hasselfeld said virtual care is still in the “early-adopter phase.” While many physicians said they would like more than half of their time devoted to telehealth, a larger proportion was more likely to say they wanted very little time devoted to it, Dr. Hasselfeld said. Among those wanting to do it are some who want to do all of their visits virtually, he said.

Those who are eager to do it will be those guiding the change, Dr. Hasselfeld said.

“As we move forward – and thinking about how to optimize virtual-care options for your patients – it’s not going to be a forced issue,” he said.

Providing better access to certain patient groups continues to be a challenge. A dashboard developed at Hopkins to identify groups who are at a technological disadvantage and don’t have ready access to telemedicine found that those living in low-income zip codes, African-Americans, and those on Medicaid and Medicare tend to have higher percentages of “audio-only” visits, mainly because of lack of connectivity allowing video visits, Dr. Hasselfeld said.

The lower share of video visits in the inner city suggests that access to telemedicine isn’t just a problem in remote rural areas, as the conventional wisdom has gone, he said.

“It doesn’t matter how many towers we have in downtown Baltimore, or how much fiber we have in the ground,” he said. “If you can’t have a data plan to access that high-speed Internet, or have a home with high-speed Internet, it doesn’t matter.”

Hopkins has developed a tool to assess how likely it is that someone will have trouble connecting for a telemedicine visit – if they’ve previously had an audio-only visit, for instance – and try to get in touch with those patients shortly before a visit so that it runs smoothly, Dr. Hasselfeld said.

The explosion of telemedicine has led to the rise of companies providing care through apps on phones and tablets, he said.

“This is real care being provided to our patients through nontraditional routes, and this is a new force, one our patients see out in the marketplace,” he said. “We have to acknowledge and wrestle with the fact that convenience is a new part of what it means to [provide] access [to] care for patients.”

Heather Hirsch, MD, an internist with Brigham and Women’s Hospital in Boston, said in an interview after the session that telemedicine is poised to improve care.

“I think the good is definitely going to outweigh the bad so long as the infrastructure and the legislation will allow it,” said Dr. Hirsch, who does about half of her visits in person and half through telemedicine, which she performs while at the office. “It does allow for a lot of flexibility for both patients and providers.”

But health care at academic medical centers, she said, needs to adjust to the times.

“We need [academic medicine] for so many reasons,” she said, “but the reality is that it moves very slowly, and the old infrastructure and the slowness to catch up with technology is the worry.”

Dr. Hasselfeld reported financial relationships with Humana and TRUE-See Systems.

CHICAGO – Both physicians and patients like the idea of having health care delivered virtually, and telehealth will likely continue to be prominent in the U.S. medical landscape, according to the medical director for digital health and telemedicine at Johns Hopkins Medicine, Baltimore.

This physician, Brian Hasselfeld, MD, said his university’s health system did 50-80 telemedicine visits a month before COVID, during a presentation at the annual meeting of the American College of Physicians. This soared to close to 100,000 a month in the pandemic, and now the health system does close to 40,000 a month, he continued.

“Life is definitely different in how we engage with our patients on a day-to-day basis,” said Dr. Hasselfeld, who oversees the telehealth for six hospitals and 50 ambulatory-care locations in Maryland and three other states.

Attitudes gauged in Johns Hopkins surveys suggest that a lot of medical care will continue to be provided by telemedicine. Nine out of 10 patients said they would likely recommend telemedicine to friends and family, and 88% said it would be either moderately, very, or extremely important to have video visit options in the future, he said.

A survey of the Hopkins system’s 3,600 physicians, which generated about 1,300 responses, found that physicians would like to have a considerable chunk of time set aside for telemedicine visits – the median response was 30%.
 

Virtual care is in ‘early-adopter phase’

But Dr. Hasselfeld said virtual care is still in the “early-adopter phase.” While many physicians said they would like more than half of their time devoted to telehealth, a larger proportion was more likely to say they wanted very little time devoted to it, Dr. Hasselfeld said. Among those wanting to do it are some who want to do all of their visits virtually, he said.

Those who are eager to do it will be those guiding the change, Dr. Hasselfeld said.

“As we move forward – and thinking about how to optimize virtual-care options for your patients – it’s not going to be a forced issue,” he said.

Providing better access to certain patient groups continues to be a challenge. A dashboard developed at Hopkins to identify groups who are at a technological disadvantage and don’t have ready access to telemedicine found that those living in low-income zip codes, African-Americans, and those on Medicaid and Medicare tend to have higher percentages of “audio-only” visits, mainly because of lack of connectivity allowing video visits, Dr. Hasselfeld said.

The lower share of video visits in the inner city suggests that access to telemedicine isn’t just a problem in remote rural areas, as the conventional wisdom has gone, he said.

“It doesn’t matter how many towers we have in downtown Baltimore, or how much fiber we have in the ground,” he said. “If you can’t have a data plan to access that high-speed Internet, or have a home with high-speed Internet, it doesn’t matter.”

Hopkins has developed a tool to assess how likely it is that someone will have trouble connecting for a telemedicine visit – if they’ve previously had an audio-only visit, for instance – and try to get in touch with those patients shortly before a visit so that it runs smoothly, Dr. Hasselfeld said.

The explosion of telemedicine has led to the rise of companies providing care through apps on phones and tablets, he said.

“This is real care being provided to our patients through nontraditional routes, and this is a new force, one our patients see out in the marketplace,” he said. “We have to acknowledge and wrestle with the fact that convenience is a new part of what it means to [provide] access [to] care for patients.”

Heather Hirsch, MD, an internist with Brigham and Women’s Hospital in Boston, said in an interview after the session that telemedicine is poised to improve care.

“I think the good is definitely going to outweigh the bad so long as the infrastructure and the legislation will allow it,” said Dr. Hirsch, who does about half of her visits in person and half through telemedicine, which she performs while at the office. “It does allow for a lot of flexibility for both patients and providers.”

But health care at academic medical centers, she said, needs to adjust to the times.

“We need [academic medicine] for so many reasons,” she said, “but the reality is that it moves very slowly, and the old infrastructure and the slowness to catch up with technology is the worry.”

Dr. Hasselfeld reported financial relationships with Humana and TRUE-See Systems.

CHICAGO – Both physicians and patients like the idea of having health care delivered virtually, and telehealth will likely continue to be prominent in the U.S. medical landscape, according to the medical director for digital health and telemedicine at Johns Hopkins Medicine, Baltimore.

This physician, Brian Hasselfeld, MD, said his university’s health system did 50-80 telemedicine visits a month before COVID, during a presentation at the annual meeting of the American College of Physicians. This soared to close to 100,000 a month in the pandemic, and now the health system does close to 40,000 a month, he continued.

“Life is definitely different in how we engage with our patients on a day-to-day basis,” said Dr. Hasselfeld, who oversees the telehealth for six hospitals and 50 ambulatory-care locations in Maryland and three other states.

Attitudes gauged in Johns Hopkins surveys suggest that a lot of medical care will continue to be provided by telemedicine. Nine out of 10 patients said they would likely recommend telemedicine to friends and family, and 88% said it would be either moderately, very, or extremely important to have video visit options in the future, he said.

A survey of the Hopkins system’s 3,600 physicians, which generated about 1,300 responses, found that physicians would like to have a considerable chunk of time set aside for telemedicine visits – the median response was 30%.
 

Virtual care is in ‘early-adopter phase’

But Dr. Hasselfeld said virtual care is still in the “early-adopter phase.” While many physicians said they would like more than half of their time devoted to telehealth, a larger proportion was more likely to say they wanted very little time devoted to it, Dr. Hasselfeld said. Among those wanting to do it are some who want to do all of their visits virtually, he said.

Those who are eager to do it will be those guiding the change, Dr. Hasselfeld said.

“As we move forward – and thinking about how to optimize virtual-care options for your patients – it’s not going to be a forced issue,” he said.

Providing better access to certain patient groups continues to be a challenge. A dashboard developed at Hopkins to identify groups who are at a technological disadvantage and don’t have ready access to telemedicine found that those living in low-income zip codes, African-Americans, and those on Medicaid and Medicare tend to have higher percentages of “audio-only” visits, mainly because of lack of connectivity allowing video visits, Dr. Hasselfeld said.

The lower share of video visits in the inner city suggests that access to telemedicine isn’t just a problem in remote rural areas, as the conventional wisdom has gone, he said.

“It doesn’t matter how many towers we have in downtown Baltimore, or how much fiber we have in the ground,” he said. “If you can’t have a data plan to access that high-speed Internet, or have a home with high-speed Internet, it doesn’t matter.”

Hopkins has developed a tool to assess how likely it is that someone will have trouble connecting for a telemedicine visit – if they’ve previously had an audio-only visit, for instance – and try to get in touch with those patients shortly before a visit so that it runs smoothly, Dr. Hasselfeld said.

The explosion of telemedicine has led to the rise of companies providing care through apps on phones and tablets, he said.

“This is real care being provided to our patients through nontraditional routes, and this is a new force, one our patients see out in the marketplace,” he said. “We have to acknowledge and wrestle with the fact that convenience is a new part of what it means to [provide] access [to] care for patients.”

Heather Hirsch, MD, an internist with Brigham and Women’s Hospital in Boston, said in an interview after the session that telemedicine is poised to improve care.

“I think the good is definitely going to outweigh the bad so long as the infrastructure and the legislation will allow it,” said Dr. Hirsch, who does about half of her visits in person and half through telemedicine, which she performs while at the office. “It does allow for a lot of flexibility for both patients and providers.”

But health care at academic medical centers, she said, needs to adjust to the times.

“We need [academic medicine] for so many reasons,” she said, “but the reality is that it moves very slowly, and the old infrastructure and the slowness to catch up with technology is the worry.”

Dr. Hasselfeld reported financial relationships with Humana and TRUE-See Systems.

Counting calories, joining a gym, and taking part in exercise programs are popular methods used by people in the United Kingdom who want to shed some pounds, but they seem to be fairly ineffective strategies, according to an investigation.

A survey of adults with obesity from six countries in western Europe found that most who set out to reduce a meaningful amount of weight failed in their attempt.

The preliminary results, presented in two posters at the European Congress on Obesity, underlined the need for better support and solutions for weight management, the authors suggested.

Marc Evans, MB, BCh, a consultant physician in diabetes and endocrinology, from University Hospital, Cardiff, Wales, who led the analysis, said that, “while obesity’s impact on health is well known, our finding that a sizable proportion of adults with obesity appear at elevated risk of hospitalization or surgery due to multiple underlying illnesses, undoubtedly adds a sense of urgency to tackling Europe’s growing obesity epidemic.”

The study, which also involved analytics consultancy firm Lane Clark & Peacock, conducted a cross-sectional survey of 1,850 adults. Of those 500 were from the UK, and the remainder from France, Germany, Italy, Spain, and Sweden.

All participants had a body mass index of 30 kg/m², or higher. More specifically, 56.3%; were classified as obesity class I, 26.8% obesity class II, and 16.9% obesity class III.
 

Obesity-related conditions

In total, 25.7% of participants reported no obesity-related health conditions, 28.4% had one condition, 19.6% had two, and 26.3% had three or more. The most common comorbidities were hypertension, dyslipidemia, and type 2 diabetes.

Overall, 78.6% of respondents reported having tried to lose weight in the previous year. Asked in a questionnaire about how they had tried to achieve this, the responses indicated that the most common strategies were:

• Calorie-controlled/restricted diet (71.9%)
• Exercise program course (21.9%)
• Pharmaceutical treatment/medication (12.3%)
• Joined a gym (12%)
• Digital health app (9.7%)

Among other participants, 8.1% said they had used alternative treatments, 7.6% a weight loss service, and 2.1% cognitive-behavioral therapy.

Analysis of the survey results showed that 78% of the individuals who attempted to lose weight did not achieve a clinically meaningful loss of 5% or more of their body weight, while some actually weighed more afterward.

Exercise and restricted diet

Notably, while exercise and calorie-controlled or restricted diets were among the most popular weight-loss methods in U.K. participants, they were amongst the least successful strategies. For instance, while 26.5% of adults who controlled their diet said they had lost weight, 17.1% reported their weight had increased. For those who took part in an exercise program, 33.3% said they lost weight, but 15.5% said they gained weight.

Signing up for gym membership also scored poorly, with 27% shedding weight, compared with 32.4% who put weight on.

“Our survey results indicate that, while the majority of adults with obesity are actively trying to reduce their weight, using a variety of strategies, most are unsuccessful,” said Dr. Evans.

Further studies were needed to assess whether people who lose weight succeed in maintaining their weight loss, the authors said.

The conference posters have yet to be published in a journal but were peer reviewed by the ECO selection committee.

The studies were sponsored by Novo Nordisk, a researcher into and manufacturer of diabetes and obesity medications, and employer of several of the coauthors.

A version of this article first appeared on Medscape UK/Univadis.

Counting calories, joining a gym, and taking part in exercise programs are popular methods used by people in the United Kingdom who want to shed some pounds, but they seem to be fairly ineffective strategies, according to an investigation.

A survey of adults with obesity from six countries in western Europe found that most who set out to reduce a meaningful amount of weight failed in their attempt.

The preliminary results, presented in two posters at the European Congress on Obesity, underlined the need for better support and solutions for weight management, the authors suggested.

Marc Evans, MB, BCh, a consultant physician in diabetes and endocrinology, from University Hospital, Cardiff, Wales, who led the analysis, said that, “while obesity’s impact on health is well known, our finding that a sizable proportion of adults with obesity appear at elevated risk of hospitalization or surgery due to multiple underlying illnesses, undoubtedly adds a sense of urgency to tackling Europe’s growing obesity epidemic.”

The study, which also involved analytics consultancy firm Lane Clark & Peacock, conducted a cross-sectional survey of 1,850 adults. Of those 500 were from the UK, and the remainder from France, Germany, Italy, Spain, and Sweden.

All participants had a body mass index of 30 kg/m², or higher. More specifically, 56.3%; were classified as obesity class I, 26.8% obesity class II, and 16.9% obesity class III.
 

Obesity-related conditions

In total, 25.7% of participants reported no obesity-related health conditions, 28.4% had one condition, 19.6% had two, and 26.3% had three or more. The most common comorbidities were hypertension, dyslipidemia, and type 2 diabetes.

Overall, 78.6% of respondents reported having tried to lose weight in the previous year. Asked in a questionnaire about how they had tried to achieve this, the responses indicated that the most common strategies were:

• Calorie-controlled/restricted diet (71.9%)
• Exercise program course (21.9%)
• Pharmaceutical treatment/medication (12.3%)
• Joined a gym (12%)
• Digital health app (9.7%)

Among other participants, 8.1% said they had used alternative treatments, 7.6% a weight loss service, and 2.1% cognitive-behavioral therapy.

Analysis of the survey results showed that 78% of the individuals who attempted to lose weight did not achieve a clinically meaningful loss of 5% or more of their body weight, while some actually weighed more afterward.

Exercise and restricted diet

Notably, while exercise and calorie-controlled or restricted diets were among the most popular weight-loss methods in U.K. participants, they were amongst the least successful strategies. For instance, while 26.5% of adults who controlled their diet said they had lost weight, 17.1% reported their weight had increased. For those who took part in an exercise program, 33.3% said they lost weight, but 15.5% said they gained weight.

Signing up for gym membership also scored poorly, with 27% shedding weight, compared with 32.4% who put weight on.

“Our survey results indicate that, while the majority of adults with obesity are actively trying to reduce their weight, using a variety of strategies, most are unsuccessful,” said Dr. Evans.

Further studies were needed to assess whether people who lose weight succeed in maintaining their weight loss, the authors said.

The conference posters have yet to be published in a journal but were peer reviewed by the ECO selection committee.

The studies were sponsored by Novo Nordisk, a researcher into and manufacturer of diabetes and obesity medications, and employer of several of the coauthors.

A version of this article first appeared on Medscape UK/Univadis.

Counting calories, joining a gym, and taking part in exercise programs are popular methods used by people in the United Kingdom who want to shed some pounds, but they seem to be fairly ineffective strategies, according to an investigation.

A survey of adults with obesity from six countries in western Europe found that most who set out to reduce a meaningful amount of weight failed in their attempt.

The preliminary results, presented in two posters at the European Congress on Obesity, underlined the need for better support and solutions for weight management, the authors suggested.

Marc Evans, MB, BCh, a consultant physician in diabetes and endocrinology, from University Hospital, Cardiff, Wales, who led the analysis, said that, “while obesity’s impact on health is well known, our finding that a sizable proportion of adults with obesity appear at elevated risk of hospitalization or surgery due to multiple underlying illnesses, undoubtedly adds a sense of urgency to tackling Europe’s growing obesity epidemic.”

The study, which also involved analytics consultancy firm Lane Clark & Peacock, conducted a cross-sectional survey of 1,850 adults. Of those 500 were from the UK, and the remainder from France, Germany, Italy, Spain, and Sweden.

All participants had a body mass index of 30 kg/m², or higher. More specifically, 56.3%; were classified as obesity class I, 26.8% obesity class II, and 16.9% obesity class III.
 

Obesity-related conditions

In total, 25.7% of participants reported no obesity-related health conditions, 28.4% had one condition, 19.6% had two, and 26.3% had three or more. The most common comorbidities were hypertension, dyslipidemia, and type 2 diabetes.

Overall, 78.6% of respondents reported having tried to lose weight in the previous year. Asked in a questionnaire about how they had tried to achieve this, the responses indicated that the most common strategies were:

• Calorie-controlled/restricted diet (71.9%)
• Exercise program course (21.9%)
• Pharmaceutical treatment/medication (12.3%)
• Joined a gym (12%)
• Digital health app (9.7%)

Among other participants, 8.1% said they had used alternative treatments, 7.6% a weight loss service, and 2.1% cognitive-behavioral therapy.

Analysis of the survey results showed that 78% of the individuals who attempted to lose weight did not achieve a clinically meaningful loss of 5% or more of their body weight, while some actually weighed more afterward.

Exercise and restricted diet

Notably, while exercise and calorie-controlled or restricted diets were among the most popular weight-loss methods in U.K. participants, they were amongst the least successful strategies. For instance, while 26.5% of adults who controlled their diet said they had lost weight, 17.1% reported their weight had increased. For those who took part in an exercise program, 33.3% said they lost weight, but 15.5% said they gained weight.

Signing up for gym membership also scored poorly, with 27% shedding weight, compared with 32.4% who put weight on.

“Our survey results indicate that, while the majority of adults with obesity are actively trying to reduce their weight, using a variety of strategies, most are unsuccessful,” said Dr. Evans.

Further studies were needed to assess whether people who lose weight succeed in maintaining their weight loss, the authors said.

The conference posters have yet to be published in a journal but were peer reviewed by the ECO selection committee.

The studies were sponsored by Novo Nordisk, a researcher into and manufacturer of diabetes and obesity medications, and employer of several of the coauthors.

A version of this article first appeared on Medscape UK/Univadis.

The more boosters the better? Data from Israel show that immune protection in elderly people is strengthened even further after a fourth dose. Karl Lauterbach, MD, German minister of health, recently pleaded for a second booster for those aged 18 years and older, and he pushed for a European Union–wide recommendation. He has not been able to implement this yet.

Just as before, Germany’s Standing Committee on Vaccination (STIKO) is only recommending the second booster for people aged 70 years and older, the European Medicines Agency (EMA) is recommending the fourth vaccination for everyone aged 80 years and older, and the United States has set the general age limit at 50 years.

Specialists remain skeptical about expanding the availability of the second booster. “From an immunologic perspective, people under the age of 70 with a healthy immune system do not need this fourth vaccination,” said Christiane Falk, PhD, head of the Institute for Transplantation Immunology of the Hannover Medical School (Germany) and member of the German Federal Government COVID Expert Panel, at a Science Media Center press briefing.

After the second vaccination, young healthy people are sufficiently protected against a severe course of the disease. Dr. Falk sees the STIKO recommendation as feasible, since it can be worked with. People in nursing facilities or those with additional underlying conditions would be considered for a fourth vaccination, explained Dr. Falk.
 

Complete protection unrealistic

Achieving complete protection against infection through multiple boosters is not realistic, said Christoph Neumann-Haefelin, MD, head of the Working Group for Translational Virus Immunology at the Clinic for Internal Medicine II, University Hospital Freiburg, Germany. Therefore, this should not be pursued when discussing boosters. “The aim of the booster vaccination should be to protect different groups of people against severe courses of the disease,” said Dr. Neumann-Haefelin.

Neutralizing antibodies that are only present in high concentrations for a few weeks after infection or vaccination are sometimes able to prevent the infection on their own. The immunologic memory of B cells and T cells, which ensures long-lasting protection against severe courses of the disease, is at a high level after two doses, and a third dose increases the protection more.

While people with a weak immune system need significantly more vaccinations in a shorter period to receive the same protection, too many booster vaccinations against SARS-CoV-2 are not sensible for young healthy people.
 

Immune saturation effect

A recent study in macaques showed that an adjusted Omicron booster did not lead to higher antibody titers, compared with a usual booster. In January 2022, the EMA warned against frequent consecutive boosters that may no longer produce the desired immune response.

If someone receives a booster too early, a saturation effect can occur, warned Andreas Radbruch, PhD, scientific director of the German Rheumatism Research Center Berlin. “We know this from lots of experimental studies but also from lots of other vaccinations. For example, you cannot be vaccinated against tetanus twice at 3- or 4-week intervals. Nothing at all will happen the second time,” explained Dr. Radbruch.

If the same antigen is applied again and again at the same dose, the immune system is made so active that the antigen is directly intercepted and cannot have any new effect on the immune system. This mechanism has been known for a long time, said Dr. Radbruch.
 

‘Original antigenic sin’

Premature boosting could even be a handicap in the competition between immune response and virus, said Dr. Radbruch. This is due to the principle of “original antigenic sin.” If the immune system has already come into contact with a virus, contact with a new virus variant will cause it to form antibodies predominantly against those epitopes that were already present in the original virus. As a result of this, too many boosters can weaken protection against different variants.

“We have not actually observed this with SARS-CoV-2, however,” said Dr. Radbruch. “Immunity is always extremely broad. With a double or triple vaccination, all previously existing variants are covered by an affinity-matured immune system.”

Dr. Neumann-Haefelin confirmed this and added that all virus mutations, including Omicron, have different epitopes that affect the antibody response, but the T-cell response does not differ.

Dr. Radbruch said that the vaccine protection probably lasts for decades. Following an infection or vaccination, the antibody concentration in the bone marrow is similar to that achieved after a measles or tetanus vaccination. “The vaccination is already extremely efficient. You have protection at the same magnitude as for other infectious diseases or vaccinations, which is expected to last decades,” said Dr. Radbruch.

He clarified that the decrease in antibodies after vaccination and infection is normal and does not indicate a drop in protection. “Quantity and quality must not be confused here. There is simply less mass, but the grade of remaining antibody increases.”

In the competition around the virus antigens (referred to as affinity maturation), antibodies develop that bind 10 to 100 times better and are particularly protective against the virus. The immune system is thereby sustainably effective.
 

For whom and when?

Since the immune response is age dependent, it makes more sense to administer an additional booster to elderly people than to young people. Also included in this group, however, are people whose immune system still does not provide the same level of protection after the second or even third vaccination as that of younger, healthy people.

Dr. Radbruch noted that 4% of people older than 70 years exhibited autoantibodies against interferons. The effects are huge. “That is 20% of patients in an intensive care unit – and they all have a very poor prognosis,” said Dr. Radbruch. These people are extremely threatened by the virus. Multiple vaccinations are sensible for them.

Even people with a weak immune response benefit from multiple vaccinations, confirmed Dr. Neumann-Haefelin. “We are not seeing the antibody responses here that we see in young people with healthy immune systems until the third or fourth vaccination sometimes.”

Although for young healthy people, it is particularly important to ensure a sufficient period between vaccinations so that the affinity maturation is not impaired, those with a weak immune response can be vaccinated again as soon as after 3 months.

The “optimum minimum period of time” for people with healthy immune systems is 6 months, according to Dr. Neumann-Haefelin. “This is true for everyone in whom a proper response is expected.” The vaccine protection probably lasts significantly longer, and therefore, frequent boosting may not be necessary in the future, he said. The time separation also applies for medical personnel, for whom the Robert Koch Institute also recommends a second booster.

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

The more boosters the better? Data from Israel show that immune protection in elderly people is strengthened even further after a fourth dose. Karl Lauterbach, MD, German minister of health, recently pleaded for a second booster for those aged 18 years and older, and he pushed for a European Union–wide recommendation. He has not been able to implement this yet.

Just as before, Germany’s Standing Committee on Vaccination (STIKO) is only recommending the second booster for people aged 70 years and older, the European Medicines Agency (EMA) is recommending the fourth vaccination for everyone aged 80 years and older, and the United States has set the general age limit at 50 years.

Specialists remain skeptical about expanding the availability of the second booster. “From an immunologic perspective, people under the age of 70 with a healthy immune system do not need this fourth vaccination,” said Christiane Falk, PhD, head of the Institute for Transplantation Immunology of the Hannover Medical School (Germany) and member of the German Federal Government COVID Expert Panel, at a Science Media Center press briefing.

After the second vaccination, young healthy people are sufficiently protected against a severe course of the disease. Dr. Falk sees the STIKO recommendation as feasible, since it can be worked with. People in nursing facilities or those with additional underlying conditions would be considered for a fourth vaccination, explained Dr. Falk.
 

Complete protection unrealistic

Achieving complete protection against infection through multiple boosters is not realistic, said Christoph Neumann-Haefelin, MD, head of the Working Group for Translational Virus Immunology at the Clinic for Internal Medicine II, University Hospital Freiburg, Germany. Therefore, this should not be pursued when discussing boosters. “The aim of the booster vaccination should be to protect different groups of people against severe courses of the disease,” said Dr. Neumann-Haefelin.

Neutralizing antibodies that are only present in high concentrations for a few weeks after infection or vaccination are sometimes able to prevent the infection on their own. The immunologic memory of B cells and T cells, which ensures long-lasting protection against severe courses of the disease, is at a high level after two doses, and a third dose increases the protection more.

While people with a weak immune system need significantly more vaccinations in a shorter period to receive the same protection, too many booster vaccinations against SARS-CoV-2 are not sensible for young healthy people.
 

Immune saturation effect

A recent study in macaques showed that an adjusted Omicron booster did not lead to higher antibody titers, compared with a usual booster. In January 2022, the EMA warned against frequent consecutive boosters that may no longer produce the desired immune response.

If someone receives a booster too early, a saturation effect can occur, warned Andreas Radbruch, PhD, scientific director of the German Rheumatism Research Center Berlin. “We know this from lots of experimental studies but also from lots of other vaccinations. For example, you cannot be vaccinated against tetanus twice at 3- or 4-week intervals. Nothing at all will happen the second time,” explained Dr. Radbruch.

If the same antigen is applied again and again at the same dose, the immune system is made so active that the antigen is directly intercepted and cannot have any new effect on the immune system. This mechanism has been known for a long time, said Dr. Radbruch.
 

‘Original antigenic sin’

Premature boosting could even be a handicap in the competition between immune response and virus, said Dr. Radbruch. This is due to the principle of “original antigenic sin.” If the immune system has already come into contact with a virus, contact with a new virus variant will cause it to form antibodies predominantly against those epitopes that were already present in the original virus. As a result of this, too many boosters can weaken protection against different variants.

“We have not actually observed this with SARS-CoV-2, however,” said Dr. Radbruch. “Immunity is always extremely broad. With a double or triple vaccination, all previously existing variants are covered by an affinity-matured immune system.”

Dr. Neumann-Haefelin confirmed this and added that all virus mutations, including Omicron, have different epitopes that affect the antibody response, but the T-cell response does not differ.

Dr. Radbruch said that the vaccine protection probably lasts for decades. Following an infection or vaccination, the antibody concentration in the bone marrow is similar to that achieved after a measles or tetanus vaccination. “The vaccination is already extremely efficient. You have protection at the same magnitude as for other infectious diseases or vaccinations, which is expected to last decades,” said Dr. Radbruch.

He clarified that the decrease in antibodies after vaccination and infection is normal and does not indicate a drop in protection. “Quantity and quality must not be confused here. There is simply less mass, but the grade of remaining antibody increases.”

In the competition around the virus antigens (referred to as affinity maturation), antibodies develop that bind 10 to 100 times better and are particularly protective against the virus. The immune system is thereby sustainably effective.
 

For whom and when?

Since the immune response is age dependent, it makes more sense to administer an additional booster to elderly people than to young people. Also included in this group, however, are people whose immune system still does not provide the same level of protection after the second or even third vaccination as that of younger, healthy people.

Dr. Radbruch noted that 4% of people older than 70 years exhibited autoantibodies against interferons. The effects are huge. “That is 20% of patients in an intensive care unit – and they all have a very poor prognosis,” said Dr. Radbruch. These people are extremely threatened by the virus. Multiple vaccinations are sensible for them.

Even people with a weak immune response benefit from multiple vaccinations, confirmed Dr. Neumann-Haefelin. “We are not seeing the antibody responses here that we see in young people with healthy immune systems until the third or fourth vaccination sometimes.”

Although for young healthy people, it is particularly important to ensure a sufficient period between vaccinations so that the affinity maturation is not impaired, those with a weak immune response can be vaccinated again as soon as after 3 months.

The “optimum minimum period of time” for people with healthy immune systems is 6 months, according to Dr. Neumann-Haefelin. “This is true for everyone in whom a proper response is expected.” The vaccine protection probably lasts significantly longer, and therefore, frequent boosting may not be necessary in the future, he said. The time separation also applies for medical personnel, for whom the Robert Koch Institute also recommends a second booster.

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

The more boosters the better? Data from Israel show that immune protection in elderly people is strengthened even further after a fourth dose. Karl Lauterbach, MD, German minister of health, recently pleaded for a second booster for those aged 18 years and older, and he pushed for a European Union–wide recommendation. He has not been able to implement this yet.

Just as before, Germany’s Standing Committee on Vaccination (STIKO) is only recommending the second booster for people aged 70 years and older, the European Medicines Agency (EMA) is recommending the fourth vaccination for everyone aged 80 years and older, and the United States has set the general age limit at 50 years.

Specialists remain skeptical about expanding the availability of the second booster. “From an immunologic perspective, people under the age of 70 with a healthy immune system do not need this fourth vaccination,” said Christiane Falk, PhD, head of the Institute for Transplantation Immunology of the Hannover Medical School (Germany) and member of the German Federal Government COVID Expert Panel, at a Science Media Center press briefing.

After the second vaccination, young healthy people are sufficiently protected against a severe course of the disease. Dr. Falk sees the STIKO recommendation as feasible, since it can be worked with. People in nursing facilities or those with additional underlying conditions would be considered for a fourth vaccination, explained Dr. Falk.
 

Complete protection unrealistic

Achieving complete protection against infection through multiple boosters is not realistic, said Christoph Neumann-Haefelin, MD, head of the Working Group for Translational Virus Immunology at the Clinic for Internal Medicine II, University Hospital Freiburg, Germany. Therefore, this should not be pursued when discussing boosters. “The aim of the booster vaccination should be to protect different groups of people against severe courses of the disease,” said Dr. Neumann-Haefelin.

Neutralizing antibodies that are only present in high concentrations for a few weeks after infection or vaccination are sometimes able to prevent the infection on their own. The immunologic memory of B cells and T cells, which ensures long-lasting protection against severe courses of the disease, is at a high level after two doses, and a third dose increases the protection more.

While people with a weak immune system need significantly more vaccinations in a shorter period to receive the same protection, too many booster vaccinations against SARS-CoV-2 are not sensible for young healthy people.
 

Immune saturation effect

A recent study in macaques showed that an adjusted Omicron booster did not lead to higher antibody titers, compared with a usual booster. In January 2022, the EMA warned against frequent consecutive boosters that may no longer produce the desired immune response.

If someone receives a booster too early, a saturation effect can occur, warned Andreas Radbruch, PhD, scientific director of the German Rheumatism Research Center Berlin. “We know this from lots of experimental studies but also from lots of other vaccinations. For example, you cannot be vaccinated against tetanus twice at 3- or 4-week intervals. Nothing at all will happen the second time,” explained Dr. Radbruch.

If the same antigen is applied again and again at the same dose, the immune system is made so active that the antigen is directly intercepted and cannot have any new effect on the immune system. This mechanism has been known for a long time, said Dr. Radbruch.
 

‘Original antigenic sin’

Premature boosting could even be a handicap in the competition between immune response and virus, said Dr. Radbruch. This is due to the principle of “original antigenic sin.” If the immune system has already come into contact with a virus, contact with a new virus variant will cause it to form antibodies predominantly against those epitopes that were already present in the original virus. As a result of this, too many boosters can weaken protection against different variants.

“We have not actually observed this with SARS-CoV-2, however,” said Dr. Radbruch. “Immunity is always extremely broad. With a double or triple vaccination, all previously existing variants are covered by an affinity-matured immune system.”

Dr. Neumann-Haefelin confirmed this and added that all virus mutations, including Omicron, have different epitopes that affect the antibody response, but the T-cell response does not differ.

Dr. Radbruch said that the vaccine protection probably lasts for decades. Following an infection or vaccination, the antibody concentration in the bone marrow is similar to that achieved after a measles or tetanus vaccination. “The vaccination is already extremely efficient. You have protection at the same magnitude as for other infectious diseases or vaccinations, which is expected to last decades,” said Dr. Radbruch.

He clarified that the decrease in antibodies after vaccination and infection is normal and does not indicate a drop in protection. “Quantity and quality must not be confused here. There is simply less mass, but the grade of remaining antibody increases.”

In the competition around the virus antigens (referred to as affinity maturation), antibodies develop that bind 10 to 100 times better and are particularly protective against the virus. The immune system is thereby sustainably effective.
 

For whom and when?

Since the immune response is age dependent, it makes more sense to administer an additional booster to elderly people than to young people. Also included in this group, however, are people whose immune system still does not provide the same level of protection after the second or even third vaccination as that of younger, healthy people.

Dr. Radbruch noted that 4% of people older than 70 years exhibited autoantibodies against interferons. The effects are huge. “That is 20% of patients in an intensive care unit – and they all have a very poor prognosis,” said Dr. Radbruch. These people are extremely threatened by the virus. Multiple vaccinations are sensible for them.

Even people with a weak immune response benefit from multiple vaccinations, confirmed Dr. Neumann-Haefelin. “We are not seeing the antibody responses here that we see in young people with healthy immune systems until the third or fourth vaccination sometimes.”

Although for young healthy people, it is particularly important to ensure a sufficient period between vaccinations so that the affinity maturation is not impaired, those with a weak immune response can be vaccinated again as soon as after 3 months.

The “optimum minimum period of time” for people with healthy immune systems is 6 months, according to Dr. Neumann-Haefelin. “This is true for everyone in whom a proper response is expected.” The vaccine protection probably lasts significantly longer, and therefore, frequent boosting may not be necessary in the future, he said. The time separation also applies for medical personnel, for whom the Robert Koch Institute also recommends a second booster.

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

About 60% of physicians cite documenting information in the electronic health record and other paperwork as major contributors to burnout. Physicians have been working with a variety of ways to reduce their documentation burdens; could one of them be right for you?

Two methods involve human scribes – working either on-site or off-site. Two other methods involve digital solutions: The first is widely used speech-to-text software, which requires the doctors to manually enter the text into the EHR; the second uses artificial intelligence (AI) to not only turn speech into text but to also automatically organize it and enter it into the EHR.

These AI solutions, which are only a few years old, are widely considered to be a work in progress – but many doctors who have used these products are impressed.
 

Other people do the documenting: On-site scribes

“It’s estimated that now one in five to one in eight doctors use scribes,” said Jeffrey A. Gold, MD, an internist who has studied the phenomenon. Utilization is already very high in emergency medicine and has been surging in specialties such as orthopedic surgery; it is also growing in primary care.

Scribes work with the doctor and enter information into the EHR. Their numbers have reportedly been rising in recent years, as more doctors look for ways to cut back on their documentation, according to Dr. Gold, vice chair for quality and safety at the department of medicine at Oregon Health and Science University, Portland.

The price tag of $33,000 a year or more for an on-site scribe is a major barrier. And because the typical scribe only works for 1-1.5 years, they must be constantly hired and trained, which is done by scribing services such as Scrivas in Miami.

However, Scrivas CEO Fernando G. Mendoza, MD, said scribes typically pay for themselves because they allow physicians to see more patients. Scribes can save doctors 2-3 hours of work per day, increase reimbursement by around 20% by producing more detailed notes, and improve satisfaction for both patients and doctors, according to several studies. In one study, physician documentation time significantly decreased, averaging 3 minutes per patient and 36 minutes per session.

Despite these possible savings, many health systems resisted hiring scribes for their employed physicians until the past few years, according to Kevin Brady, president of Physicians Angels, a scribing service based in Toledo, Ohio. “They figured they’d just spent millions on EHRs and didn’t want to spend any more,” he said. “They were also waiting for the EHR vendors to simplify documentation, but that never happened.”

Mr. Brady said what finally convinced many systems to invest in scribes was the need to reduce physician turnover and improve recruitment. Newly minted physicians often look for jobs that don’t interfere with their leisure time.
 

On-site scribes

On-site scribes accompany the doctor into the exam room and type the note during the encounter. Typically, the note is completed when the encounter is over, allowing for orders to be carried out immediately.

The traditional scribe is a premed student who wants to get acquainted with medicine and is thus willing to make a fairly low income. This career trajectory is the reason scribes have a high turnover. As demand surged, the scribe pool was supplemented with students aspiring to other health care professions like nursing, and even with people who want to make a career of scribing.

Since scribes have to set aside time for studying, scribe companies provide each physician-customer with one or two backup scribes. Dr. Mendoza bills his scribes as “personal assistants” who can do some nonclinical tasks beyond filling in the EHR, such as reminding doctors about the need to order a test or check in on another patient briefly before moving on to the next exam room.

Dr. Gold, however, warned against allowing “functional creep,” where scribes are asked to carry out tasks beyond their abilities, such as interpreting medical data. He added that doctors are expected to read through and sign all scribe-generated orders.

Some practices grow their own scribes, cross-training their medical assistants (MAs) to do the work. This addresses the turnover problem and could reduce costs. MAs already know clinical terms and how the doctor works, and they may be able to get special training at a local community college. However, some MAs do not want this extra work, and in any case, the work would take them away from other duties.

How often do physicians use their scribes? “Our doctors generally use them for all of their visits, but surgeons tend to limit use to their clinic days when they’re not in surgery,” said Tony Andrulonis, MD, president of ScribeAmerica in Fort Lauderdale, Fla.
 

Virtual scribes work off-site

Virtual scribes, who operate remotely from the doctor and can cost up to $10 less per hour than on-site scribes, got a boost during the COVID-19 pandemic because they fit well with telemedicine visits. Furthermore, the growing availability of virtual scribes from abroad has made scribes even more affordable.

“When doctors could no longer work on-site due to the pandemic, they replaced their on-site scribes with virtual scribes, and to some extent this trend is still going on,” Dr. Gold said.

One downside with virtual scribes is that they cannot do many of the extra tasks that on-site scribes can do. However, they are often a necessity in rural areas where on-site scribes are not available. In addition to having an audio-video connection, they may also just be on audio in areas where internet reception is poor or the patient wants privacy, Dr. Andrulonis said.

Mr. Brady said Physicians Angels uses offshore scribes from India. The company charges $16-$18 per hour, compared with $26-$28 per hour for U.S.-based virtual scribes. He said well over half of his clients are family physicians, who appreciate the lower cost.

Another advantage of offshore scribes is slower turnover and full-time availability. Mr. Brady said his scribes usually stay with the company for 5-6 years and are always available. “This is their full-time job,” Brady said.

Mr. Brady said when large organizations arrange with his company for scribes, often the goal is that the scribes pay for themselves. “They’ll tell their doctors: ‘We’ll let you have scribes as long as you see one or two more patients a day,’ ” he said. Mr. Brady then helps the organization reach that goal, which he said is easily achievable, except when doctors have no clear incentive to see more patients. He also works with clients on other goals, such as higher quality of life or time saved.
 

Speech-to-text software

For years, doctors have been using speech-to-text software to transform their speech into notes. They speak into the microphone, calling out punctuation and referring to prep-made templates for routine tasks. As they speak, the text appears on a screen. They can correct the text if necessary, and then they must put that information into the EHR.

Speech-to-text systems are used by more physicians than those using human scribes. Nuance’s Dragon Medical One system is the most popular, with more than 1000 large healthcare organizations signed up. Competitors include Dolbey, Entrada, and nVoq.

Prices are just a fraction of the cost of a human scribe. Dolbey’s Fusion Narrate system, for example, costs about $800-$850 a year per user. Doctors should shop around for these systems, because prices can vary by 30%-50%, said Wayne Kaniewski, MD, a retired family and urgent care physician and now owner and CEO of Twin Cities EMR Consulting in Minneapolis.

As a contracted reseller of the nVoq and Dolbey systems, Dr. Kaniewski provides training and support. During 13 years in business, he said machine dictation systems have become faster, more accurate, and, thanks to cloud-based technology, easier to set up.
 

Digital assistants

AI software, also known as digital assistants, takes speech-to-text software to the next logical step – organizing and automatically entering the information into the EHR. Using ambient technology, a smartphone captures the physician-patient conversation in the exam room, extracts the needed information, and distributes it in the EHR.

The cost is about one-sixth that of a human scribe, but higher than the cost for speech-to-text software because the technology still makes errors and requires a human at the software company to guide the process.

Currently about 10 companies sell digital scribes, including Nuance’s Dragon Medical One, NoteSwift, DeepScribe, and ScribeAmerica. These systems can be connected to the major EHR systems, and in some cases EHR systems have agreements with digital scribe vendors so that their systems can be seamlessly connected.

“DAX software can understand nonlinear conversations – the way normal conversations bounce from topic to topic,” said Kenneth Harper, general manager of Nuance’s Ambient Clinical Intelligence Division. “This level of technology was not possible 5 years ago.”

Mr. Harper said DAX saves doctors 6 minutes per patient on average, and 70% of doctors using it reported less burnout and fatigue. Kansas University Medical Center has been testing DAX with physicians there. Many of them no longer need to write up their notes after hours, said Denton Shanks, DO, the medical center’s digital health medical director.

One of the things Dr. Shanks likes about DAX is that it remembers all the details of a visit. As a family physician, “there are something like 15 different problems that come up in one typical visit. Before, I had to carry those problems in my head, and when I wrote up my notes at the end of the day, I might have forgotten a few of them. Not so with DAX.”

Dr. Shanks knows he has to speak clearly and unambiguously when using DAX. “DAX can only document what it hears, so I describe what I am looking at in a physical exam or I might further explain the patient’s account so DAX can pick up on it.”
 

Are digital assistants ready for doctors?

Since a human at the software company is needed to guide the system, it takes a few hours for the digital assistant to complete entries into the EHR, but vendors are looking for ways to eliminate human guidance.

“We’re definitely moving toward digital scribes, but we’re not there yet,” Dr. Gold said, pointing to a 2018 study that found a significantly higher error rate for speech recognition software than for human scribes.

Dr. Kaniewski added that digital scribes pick up a great deal of irrelevant information, making for a bloated note. “Clinicians must then edit the note down, which is more work than just dictating a concise note,” he said.

Many doctors, however, are happy with these new systems. Steven Y. Lin, MD, a family physician who has been testing a digital scribe system with 40 fellow clinicians at Stanford (Calif.) Health Care, said 95% of clinicians who stayed with the trial are continuing to use the system, but he concedes that there was a relatively high dropout rate. “These people felt that they had lost control of the process when using the software.”

Furthermore, Dr. Lin is concerned that using a digital scribe may eliminate doctors’ crucial step of sitting down and writing the clinical note. Here “doctors bring together everything they have heard and then come up with the diagnosis and treatment.” He recognized that doctors could still take this step when reviewing the digital note, but it would be easy to skip.
 

What is the future for documentation aids?

Increasingly more doctors are finding ways to expedite documentation tasks. Speech-to-text software is still the most popular solution, but more physicians are now using human scribes, driven by the decisions of some large organizations to start paying for them.

However, these physicians are often expected to work harder in order for the scribes to pay for themselves, which is a solution that could, ironically, add to burnout rather than alleviate it.

Digital assistants answer these concerns because they are more affordable and are supposed to do all the work of human scribes. This software parses the physician-patient conversation into a clinical note and other data and deposits them directly into the EHR.

Most experts think digital assistants will eventually meet their promise, but it is widely thought that they’re not ready yet. It will be up to vendors like Nuance to convince skeptics that their products are ready for doctors.

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

About 60% of physicians cite documenting information in the electronic health record and other paperwork as major contributors to burnout. Physicians have been working with a variety of ways to reduce their documentation burdens; could one of them be right for you?

Two methods involve human scribes – working either on-site or off-site. Two other methods involve digital solutions: The first is widely used speech-to-text software, which requires the doctors to manually enter the text into the EHR; the second uses artificial intelligence (AI) to not only turn speech into text but to also automatically organize it and enter it into the EHR.

These AI solutions, which are only a few years old, are widely considered to be a work in progress – but many doctors who have used these products are impressed.
 

Other people do the documenting: On-site scribes

“It’s estimated that now one in five to one in eight doctors use scribes,” said Jeffrey A. Gold, MD, an internist who has studied the phenomenon. Utilization is already very high in emergency medicine and has been surging in specialties such as orthopedic surgery; it is also growing in primary care.

Scribes work with the doctor and enter information into the EHR. Their numbers have reportedly been rising in recent years, as more doctors look for ways to cut back on their documentation, according to Dr. Gold, vice chair for quality and safety at the department of medicine at Oregon Health and Science University, Portland.

The price tag of $33,000 a year or more for an on-site scribe is a major barrier. And because the typical scribe only works for 1-1.5 years, they must be constantly hired and trained, which is done by scribing services such as Scrivas in Miami.

However, Scrivas CEO Fernando G. Mendoza, MD, said scribes typically pay for themselves because they allow physicians to see more patients. Scribes can save doctors 2-3 hours of work per day, increase reimbursement by around 20% by producing more detailed notes, and improve satisfaction for both patients and doctors, according to several studies. In one study, physician documentation time significantly decreased, averaging 3 minutes per patient and 36 minutes per session.

Despite these possible savings, many health systems resisted hiring scribes for their employed physicians until the past few years, according to Kevin Brady, president of Physicians Angels, a scribing service based in Toledo, Ohio. “They figured they’d just spent millions on EHRs and didn’t want to spend any more,” he said. “They were also waiting for the EHR vendors to simplify documentation, but that never happened.”

Mr. Brady said what finally convinced many systems to invest in scribes was the need to reduce physician turnover and improve recruitment. Newly minted physicians often look for jobs that don’t interfere with their leisure time.
 

On-site scribes

On-site scribes accompany the doctor into the exam room and type the note during the encounter. Typically, the note is completed when the encounter is over, allowing for orders to be carried out immediately.

The traditional scribe is a premed student who wants to get acquainted with medicine and is thus willing to make a fairly low income. This career trajectory is the reason scribes have a high turnover. As demand surged, the scribe pool was supplemented with students aspiring to other health care professions like nursing, and even with people who want to make a career of scribing.

Since scribes have to set aside time for studying, scribe companies provide each physician-customer with one or two backup scribes. Dr. Mendoza bills his scribes as “personal assistants” who can do some nonclinical tasks beyond filling in the EHR, such as reminding doctors about the need to order a test or check in on another patient briefly before moving on to the next exam room.

Dr. Gold, however, warned against allowing “functional creep,” where scribes are asked to carry out tasks beyond their abilities, such as interpreting medical data. He added that doctors are expected to read through and sign all scribe-generated orders.

Some practices grow their own scribes, cross-training their medical assistants (MAs) to do the work. This addresses the turnover problem and could reduce costs. MAs already know clinical terms and how the doctor works, and they may be able to get special training at a local community college. However, some MAs do not want this extra work, and in any case, the work would take them away from other duties.

How often do physicians use their scribes? “Our doctors generally use them for all of their visits, but surgeons tend to limit use to their clinic days when they’re not in surgery,” said Tony Andrulonis, MD, president of ScribeAmerica in Fort Lauderdale, Fla.
 

Virtual scribes work off-site

Virtual scribes, who operate remotely from the doctor and can cost up to $10 less per hour than on-site scribes, got a boost during the COVID-19 pandemic because they fit well with telemedicine visits. Furthermore, the growing availability of virtual scribes from abroad has made scribes even more affordable.

“When doctors could no longer work on-site due to the pandemic, they replaced their on-site scribes with virtual scribes, and to some extent this trend is still going on,” Dr. Gold said.

One downside with virtual scribes is that they cannot do many of the extra tasks that on-site scribes can do. However, they are often a necessity in rural areas where on-site scribes are not available. In addition to having an audio-video connection, they may also just be on audio in areas where internet reception is poor or the patient wants privacy, Dr. Andrulonis said.

Mr. Brady said Physicians Angels uses offshore scribes from India. The company charges $16-$18 per hour, compared with $26-$28 per hour for U.S.-based virtual scribes. He said well over half of his clients are family physicians, who appreciate the lower cost.

Another advantage of offshore scribes is slower turnover and full-time availability. Mr. Brady said his scribes usually stay with the company for 5-6 years and are always available. “This is their full-time job,” Brady said.

Mr. Brady said when large organizations arrange with his company for scribes, often the goal is that the scribes pay for themselves. “They’ll tell their doctors: ‘We’ll let you have scribes as long as you see one or two more patients a day,’ ” he said. Mr. Brady then helps the organization reach that goal, which he said is easily achievable, except when doctors have no clear incentive to see more patients. He also works with clients on other goals, such as higher quality of life or time saved.
 

Speech-to-text software

For years, doctors have been using speech-to-text software to transform their speech into notes. They speak into the microphone, calling out punctuation and referring to prep-made templates for routine tasks. As they speak, the text appears on a screen. They can correct the text if necessary, and then they must put that information into the EHR.

Speech-to-text systems are used by more physicians than those using human scribes. Nuance’s Dragon Medical One system is the most popular, with more than 1000 large healthcare organizations signed up. Competitors include Dolbey, Entrada, and nVoq.

Prices are just a fraction of the cost of a human scribe. Dolbey’s Fusion Narrate system, for example, costs about $800-$850 a year per user. Doctors should shop around for these systems, because prices can vary by 30%-50%, said Wayne Kaniewski, MD, a retired family and urgent care physician and now owner and CEO of Twin Cities EMR Consulting in Minneapolis.

As a contracted reseller of the nVoq and Dolbey systems, Dr. Kaniewski provides training and support. During 13 years in business, he said machine dictation systems have become faster, more accurate, and, thanks to cloud-based technology, easier to set up.
 

Digital assistants

AI software, also known as digital assistants, takes speech-to-text software to the next logical step – organizing and automatically entering the information into the EHR. Using ambient technology, a smartphone captures the physician-patient conversation in the exam room, extracts the needed information, and distributes it in the EHR.

The cost is about one-sixth that of a human scribe, but higher than the cost for speech-to-text software because the technology still makes errors and requires a human at the software company to guide the process.

Currently about 10 companies sell digital scribes, including Nuance’s Dragon Medical One, NoteSwift, DeepScribe, and ScribeAmerica. These systems can be connected to the major EHR systems, and in some cases EHR systems have agreements with digital scribe vendors so that their systems can be seamlessly connected.

“DAX software can understand nonlinear conversations – the way normal conversations bounce from topic to topic,” said Kenneth Harper, general manager of Nuance’s Ambient Clinical Intelligence Division. “This level of technology was not possible 5 years ago.”

Mr. Harper said DAX saves doctors 6 minutes per patient on average, and 70% of doctors using it reported less burnout and fatigue. Kansas University Medical Center has been testing DAX with physicians there. Many of them no longer need to write up their notes after hours, said Denton Shanks, DO, the medical center’s digital health medical director.

One of the things Dr. Shanks likes about DAX is that it remembers all the details of a visit. As a family physician, “there are something like 15 different problems that come up in one typical visit. Before, I had to carry those problems in my head, and when I wrote up my notes at the end of the day, I might have forgotten a few of them. Not so with DAX.”

Dr. Shanks knows he has to speak clearly and unambiguously when using DAX. “DAX can only document what it hears, so I describe what I am looking at in a physical exam or I might further explain the patient’s account so DAX can pick up on it.”
 

Are digital assistants ready for doctors?

Since a human at the software company is needed to guide the system, it takes a few hours for the digital assistant to complete entries into the EHR, but vendors are looking for ways to eliminate human guidance.

“We’re definitely moving toward digital scribes, but we’re not there yet,” Dr. Gold said, pointing to a 2018 study that found a significantly higher error rate for speech recognition software than for human scribes.

Dr. Kaniewski added that digital scribes pick up a great deal of irrelevant information, making for a bloated note. “Clinicians must then edit the note down, which is more work than just dictating a concise note,” he said.

Many doctors, however, are happy with these new systems. Steven Y. Lin, MD, a family physician who has been testing a digital scribe system with 40 fellow clinicians at Stanford (Calif.) Health Care, said 95% of clinicians who stayed with the trial are continuing to use the system, but he concedes that there was a relatively high dropout rate. “These people felt that they had lost control of the process when using the software.”

Furthermore, Dr. Lin is concerned that using a digital scribe may eliminate doctors’ crucial step of sitting down and writing the clinical note. Here “doctors bring together everything they have heard and then come up with the diagnosis and treatment.” He recognized that doctors could still take this step when reviewing the digital note, but it would be easy to skip.
 

What is the future for documentation aids?

Increasingly more doctors are finding ways to expedite documentation tasks. Speech-to-text software is still the most popular solution, but more physicians are now using human scribes, driven by the decisions of some large organizations to start paying for them.

However, these physicians are often expected to work harder in order for the scribes to pay for themselves, which is a solution that could, ironically, add to burnout rather than alleviate it.

Digital assistants answer these concerns because they are more affordable and are supposed to do all the work of human scribes. This software parses the physician-patient conversation into a clinical note and other data and deposits them directly into the EHR.

Most experts think digital assistants will eventually meet their promise, but it is widely thought that they’re not ready yet. It will be up to vendors like Nuance to convince skeptics that their products are ready for doctors.

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

About 60% of physicians cite documenting information in the electronic health record and other paperwork as major contributors to burnout. Physicians have been working with a variety of ways to reduce their documentation burdens; could one of them be right for you?

Two methods involve human scribes – working either on-site or off-site. Two other methods involve digital solutions: The first is widely used speech-to-text software, which requires the doctors to manually enter the text into the EHR; the second uses artificial intelligence (AI) to not only turn speech into text but to also automatically organize it and enter it into the EHR.

These AI solutions, which are only a few years old, are widely considered to be a work in progress – but many doctors who have used these products are impressed.
 

Other people do the documenting: On-site scribes

“It’s estimated that now one in five to one in eight doctors use scribes,” said Jeffrey A. Gold, MD, an internist who has studied the phenomenon. Utilization is already very high in emergency medicine and has been surging in specialties such as orthopedic surgery; it is also growing in primary care.

Scribes work with the doctor and enter information into the EHR. Their numbers have reportedly been rising in recent years, as more doctors look for ways to cut back on their documentation, according to Dr. Gold, vice chair for quality and safety at the department of medicine at Oregon Health and Science University, Portland.

The price tag of $33,000 a year or more for an on-site scribe is a major barrier. And because the typical scribe only works for 1-1.5 years, they must be constantly hired and trained, which is done by scribing services such as Scrivas in Miami.

However, Scrivas CEO Fernando G. Mendoza, MD, said scribes typically pay for themselves because they allow physicians to see more patients. Scribes can save doctors 2-3 hours of work per day, increase reimbursement by around 20% by producing more detailed notes, and improve satisfaction for both patients and doctors, according to several studies. In one study, physician documentation time significantly decreased, averaging 3 minutes per patient and 36 minutes per session.

Despite these possible savings, many health systems resisted hiring scribes for their employed physicians until the past few years, according to Kevin Brady, president of Physicians Angels, a scribing service based in Toledo, Ohio. “They figured they’d just spent millions on EHRs and didn’t want to spend any more,” he said. “They were also waiting for the EHR vendors to simplify documentation, but that never happened.”

Mr. Brady said what finally convinced many systems to invest in scribes was the need to reduce physician turnover and improve recruitment. Newly minted physicians often look for jobs that don’t interfere with their leisure time.
 

On-site scribes

On-site scribes accompany the doctor into the exam room and type the note during the encounter. Typically, the note is completed when the encounter is over, allowing for orders to be carried out immediately.

The traditional scribe is a premed student who wants to get acquainted with medicine and is thus willing to make a fairly low income. This career trajectory is the reason scribes have a high turnover. As demand surged, the scribe pool was supplemented with students aspiring to other health care professions like nursing, and even with people who want to make a career of scribing.

Since scribes have to set aside time for studying, scribe companies provide each physician-customer with one or two backup scribes. Dr. Mendoza bills his scribes as “personal assistants” who can do some nonclinical tasks beyond filling in the EHR, such as reminding doctors about the need to order a test or check in on another patient briefly before moving on to the next exam room.

Dr. Gold, however, warned against allowing “functional creep,” where scribes are asked to carry out tasks beyond their abilities, such as interpreting medical data. He added that doctors are expected to read through and sign all scribe-generated orders.

Some practices grow their own scribes, cross-training their medical assistants (MAs) to do the work. This addresses the turnover problem and could reduce costs. MAs already know clinical terms and how the doctor works, and they may be able to get special training at a local community college. However, some MAs do not want this extra work, and in any case, the work would take them away from other duties.

How often do physicians use their scribes? “Our doctors generally use them for all of their visits, but surgeons tend to limit use to their clinic days when they’re not in surgery,” said Tony Andrulonis, MD, president of ScribeAmerica in Fort Lauderdale, Fla.
 

Virtual scribes work off-site

Virtual scribes, who operate remotely from the doctor and can cost up to $10 less per hour than on-site scribes, got a boost during the COVID-19 pandemic because they fit well with telemedicine visits. Furthermore, the growing availability of virtual scribes from abroad has made scribes even more affordable.

“When doctors could no longer work on-site due to the pandemic, they replaced their on-site scribes with virtual scribes, and to some extent this trend is still going on,” Dr. Gold said.

One downside with virtual scribes is that they cannot do many of the extra tasks that on-site scribes can do. However, they are often a necessity in rural areas where on-site scribes are not available. In addition to having an audio-video connection, they may also just be on audio in areas where internet reception is poor or the patient wants privacy, Dr. Andrulonis said.

Mr. Brady said Physicians Angels uses offshore scribes from India. The company charges $16-$18 per hour, compared with $26-$28 per hour for U.S.-based virtual scribes. He said well over half of his clients are family physicians, who appreciate the lower cost.

Another advantage of offshore scribes is slower turnover and full-time availability. Mr. Brady said his scribes usually stay with the company for 5-6 years and are always available. “This is their full-time job,” Brady said.

Mr. Brady said when large organizations arrange with his company for scribes, often the goal is that the scribes pay for themselves. “They’ll tell their doctors: ‘We’ll let you have scribes as long as you see one or two more patients a day,’ ” he said. Mr. Brady then helps the organization reach that goal, which he said is easily achievable, except when doctors have no clear incentive to see more patients. He also works with clients on other goals, such as higher quality of life or time saved.
 

Speech-to-text software

For years, doctors have been using speech-to-text software to transform their speech into notes. They speak into the microphone, calling out punctuation and referring to prep-made templates for routine tasks. As they speak, the text appears on a screen. They can correct the text if necessary, and then they must put that information into the EHR.

Speech-to-text systems are used by more physicians than those using human scribes. Nuance’s Dragon Medical One system is the most popular, with more than 1000 large healthcare organizations signed up. Competitors include Dolbey, Entrada, and nVoq.

Prices are just a fraction of the cost of a human scribe. Dolbey’s Fusion Narrate system, for example, costs about $800-$850 a year per user. Doctors should shop around for these systems, because prices can vary by 30%-50%, said Wayne Kaniewski, MD, a retired family and urgent care physician and now owner and CEO of Twin Cities EMR Consulting in Minneapolis.

As a contracted reseller of the nVoq and Dolbey systems, Dr. Kaniewski provides training and support. During 13 years in business, he said machine dictation systems have become faster, more accurate, and, thanks to cloud-based technology, easier to set up.
 

Digital assistants

AI software, also known as digital assistants, takes speech-to-text software to the next logical step – organizing and automatically entering the information into the EHR. Using ambient technology, a smartphone captures the physician-patient conversation in the exam room, extracts the needed information, and distributes it in the EHR.

The cost is about one-sixth that of a human scribe, but higher than the cost for speech-to-text software because the technology still makes errors and requires a human at the software company to guide the process.

Currently about 10 companies sell digital scribes, including Nuance’s Dragon Medical One, NoteSwift, DeepScribe, and ScribeAmerica. These systems can be connected to the major EHR systems, and in some cases EHR systems have agreements with digital scribe vendors so that their systems can be seamlessly connected.

“DAX software can understand nonlinear conversations – the way normal conversations bounce from topic to topic,” said Kenneth Harper, general manager of Nuance’s Ambient Clinical Intelligence Division. “This level of technology was not possible 5 years ago.”

Mr. Harper said DAX saves doctors 6 minutes per patient on average, and 70% of doctors using it reported less burnout and fatigue. Kansas University Medical Center has been testing DAX with physicians there. Many of them no longer need to write up their notes after hours, said Denton Shanks, DO, the medical center’s digital health medical director.

One of the things Dr. Shanks likes about DAX is that it remembers all the details of a visit. As a family physician, “there are something like 15 different problems that come up in one typical visit. Before, I had to carry those problems in my head, and when I wrote up my notes at the end of the day, I might have forgotten a few of them. Not so with DAX.”

Dr. Shanks knows he has to speak clearly and unambiguously when using DAX. “DAX can only document what it hears, so I describe what I am looking at in a physical exam or I might further explain the patient’s account so DAX can pick up on it.”
 

Are digital assistants ready for doctors?

Since a human at the software company is needed to guide the system, it takes a few hours for the digital assistant to complete entries into the EHR, but vendors are looking for ways to eliminate human guidance.

“We’re definitely moving toward digital scribes, but we’re not there yet,” Dr. Gold said, pointing to a 2018 study that found a significantly higher error rate for speech recognition software than for human scribes.

Dr. Kaniewski added that digital scribes pick up a great deal of irrelevant information, making for a bloated note. “Clinicians must then edit the note down, which is more work than just dictating a concise note,” he said.

Many doctors, however, are happy with these new systems. Steven Y. Lin, MD, a family physician who has been testing a digital scribe system with 40 fellow clinicians at Stanford (Calif.) Health Care, said 95% of clinicians who stayed with the trial are continuing to use the system, but he concedes that there was a relatively high dropout rate. “These people felt that they had lost control of the process when using the software.”

Furthermore, Dr. Lin is concerned that using a digital scribe may eliminate doctors’ crucial step of sitting down and writing the clinical note. Here “doctors bring together everything they have heard and then come up with the diagnosis and treatment.” He recognized that doctors could still take this step when reviewing the digital note, but it would be easy to skip.
 

What is the future for documentation aids?

Increasingly more doctors are finding ways to expedite documentation tasks. Speech-to-text software is still the most popular solution, but more physicians are now using human scribes, driven by the decisions of some large organizations to start paying for them.

However, these physicians are often expected to work harder in order for the scribes to pay for themselves, which is a solution that could, ironically, add to burnout rather than alleviate it.

Digital assistants answer these concerns because they are more affordable and are supposed to do all the work of human scribes. This software parses the physician-patient conversation into a clinical note and other data and deposits them directly into the EHR.

Most experts think digital assistants will eventually meet their promise, but it is widely thought that they’re not ready yet. It will be up to vendors like Nuance to convince skeptics that their products are ready for doctors.

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

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

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

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

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

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

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