A retrospective investigation using medical claims data found no elevated risk of disease flares in patients with immune-mediated inflammatory diseases (IMIDs) who received the recombinant zoster vaccine (RZV), according to research published in Arthritis & Rheumatology.

The authors of the study noted that individuals with IMIDs are at increased risk for herpes zoster and related complications, including postherpetic neuralgia, and that vaccination has been recommended for certain groups of patients with rheumatoid arthritis, inflammatory bowel disease, and psoriasis, by the American College of Rheumatology and other professional organizations for individuals aged 50 and older.

The study investigators used medical claims from IBM MarketScan, which provided data on patients aged 50-64 years, and data from the Centers for Medicare and Medicaid Services’ Medicare on patients aged 65 and older.

They defined presumed flares in three ways: hospitalization/emergency department visits for IMIDs, steroid treatment with a short-acting oral glucocorticoid, or treatment with a parenteral glucocorticoid injection. The investigators conducted a self-controlled case series (SCCS) analysis to examine any temporal link between the RZV and disease flares.

Among enrollees with IMIDs, 14.8% of the 55,654 patients in the MarketScan database and 43.2% of the 160,545 patients in the Medicare database received at least one dose of RZV during 2018-2019. The two-dose series completion within 6 months was 76.6% in the MarketScan group (age range, 50-64 years) and 85.4% among Medicare enrollees (age range, 65 years and older). In the SCCS analysis, 10% and 13% of patients developed flares in the control group as compared to 9%, and 11%-12% in the risk window following one or two doses of RZV among MarketScan and Medicare enrollees, respectively.

Based on these findings, the investigators concluded there was no statistically significant increase in flares subsequent to RZV administration for any IMID in either patients aged 50-64 years or patients aged 65 years and older following the first dose or second dose.

Nilanjana Bose, MD, a rheumatologist with Lonestar Rheumatology, Houston, Texas, who was not involved with the study, said that the research addresses a topic where there is uneasiness, namely vaccination in patients with IMIDs.

A retrospective investigation using medical claims data found no elevated risk of disease flares in patients with immune-mediated inflammatory diseases (IMIDs) who received the recombinant zoster vaccine (RZV), according to research published in Arthritis & Rheumatology.

The authors of the study noted that individuals with IMIDs are at increased risk for herpes zoster and related complications, including postherpetic neuralgia, and that vaccination has been recommended for certain groups of patients with rheumatoid arthritis, inflammatory bowel disease, and psoriasis, by the American College of Rheumatology and other professional organizations for individuals aged 50 and older.

The study investigators used medical claims from IBM MarketScan, which provided data on patients aged 50-64 years, and data from the Centers for Medicare and Medicaid Services’ Medicare on patients aged 65 and older.

They defined presumed flares in three ways: hospitalization/emergency department visits for IMIDs, steroid treatment with a short-acting oral glucocorticoid, or treatment with a parenteral glucocorticoid injection. The investigators conducted a self-controlled case series (SCCS) analysis to examine any temporal link between the RZV and disease flares.

Among enrollees with IMIDs, 14.8% of the 55,654 patients in the MarketScan database and 43.2% of the 160,545 patients in the Medicare database received at least one dose of RZV during 2018-2019. The two-dose series completion within 6 months was 76.6% in the MarketScan group (age range, 50-64 years) and 85.4% among Medicare enrollees (age range, 65 years and older). In the SCCS analysis, 10% and 13% of patients developed flares in the control group as compared to 9%, and 11%-12% in the risk window following one or two doses of RZV among MarketScan and Medicare enrollees, respectively.

Based on these findings, the investigators concluded there was no statistically significant increase in flares subsequent to RZV administration for any IMID in either patients aged 50-64 years or patients aged 65 years and older following the first dose or second dose.

Nilanjana Bose, MD, a rheumatologist with Lonestar Rheumatology, Houston, Texas, who was not involved with the study, said that the research addresses a topic where there is uneasiness, namely vaccination in patients with IMIDs.

A retrospective investigation using medical claims data found no elevated risk of disease flares in patients with immune-mediated inflammatory diseases (IMIDs) who received the recombinant zoster vaccine (RZV), according to research published in Arthritis & Rheumatology.

The authors of the study noted that individuals with IMIDs are at increased risk for herpes zoster and related complications, including postherpetic neuralgia, and that vaccination has been recommended for certain groups of patients with rheumatoid arthritis, inflammatory bowel disease, and psoriasis, by the American College of Rheumatology and other professional organizations for individuals aged 50 and older.

The study investigators used medical claims from IBM MarketScan, which provided data on patients aged 50-64 years, and data from the Centers for Medicare and Medicaid Services’ Medicare on patients aged 65 and older.

They defined presumed flares in three ways: hospitalization/emergency department visits for IMIDs, steroid treatment with a short-acting oral glucocorticoid, or treatment with a parenteral glucocorticoid injection. The investigators conducted a self-controlled case series (SCCS) analysis to examine any temporal link between the RZV and disease flares.

Among enrollees with IMIDs, 14.8% of the 55,654 patients in the MarketScan database and 43.2% of the 160,545 patients in the Medicare database received at least one dose of RZV during 2018-2019. The two-dose series completion within 6 months was 76.6% in the MarketScan group (age range, 50-64 years) and 85.4% among Medicare enrollees (age range, 65 years and older). In the SCCS analysis, 10% and 13% of patients developed flares in the control group as compared to 9%, and 11%-12% in the risk window following one or two doses of RZV among MarketScan and Medicare enrollees, respectively.

Based on these findings, the investigators concluded there was no statistically significant increase in flares subsequent to RZV administration for any IMID in either patients aged 50-64 years or patients aged 65 years and older following the first dose or second dose.

Nilanjana Bose, MD, a rheumatologist with Lonestar Rheumatology, Houston, Texas, who was not involved with the study, said that the research addresses a topic where there is uneasiness, namely vaccination in patients with IMIDs.

Physicians who are sleep deprived have less empathy for patients who report pain – and they prescribe fewer analgesics, new research suggests.

In the first of two studies, resident physicians were presented with two hypothetical scenarios involving a patient who complains of pain. They were asked about their likelihood of prescribing pain medication. The test was given to one group of residents who were just starting their day and to another group who were at the end of their night shift after being on call for 26 hours.

Results showed that the night shift residents were less likely than their daytime counterparts to say they would prescribe pain medication to the patients.

In further analysis of discharge notes from more than 13,000 electronic records of patients presenting with pain complaints at hospitals in Israel and the United States, the likelihood of an analgesic being prescribed during the night shift was 11% lower in Israel and 9% lower in the United States, compared with the day shift.

“Pain management is a major challenge, and a doctor’s perception of a patient’s subjective pain is susceptible to bias,” coinvestigator David Gozal, MD, the Marie M. and Harry L. Smith Endowed Chair of Child Health, University of Missouri–Columbia, said in a press release.

“This study demonstrated that night shift work is an important and previously unrecognized source of bias in pain management, likely stemming from impaired perception of pain,” Dr. Gozal added.

The findings were published online in the Proceedings of the National Academy of Sciences.
 

‘Directional’ differences

Senior investigator Alex Gileles-Hillel, MD, senior pediatric pulmonologist and sleep researcher at Hadassah University Medical Center, Jerusalem, said in an interview that physicians must make “complex assessments of patients’ subjective pain experience” – and the “subjective nature of pain management decisions can give rise to various biases.”

Dr. Gileles-Hillel has previously researched the cognitive toll of night shift work on physicians.

“It’s pretty established, for example, not to drive when sleep deprived because cognition is impaired,” he said. The current study explored whether sleep deprivation could affect areas other than cognition, including emotions and empathy.

The researchers used “two complementary approaches.” First, they administered tests to measure empathy and pain management decisions in 67 resident physicians at Hadassah Medical Centers either following a 26-hour night shift that began at 8:00 a.m. the day before (n = 36) or immediately before starting the workday (n = 31).

There were no significant differences in demographic, sleep, or burnout measures between the two groups, except that night shift physicians had slept less than those in the daytime group (2.93 vs. 5.96 hours).

Participants completed two tasks. In the empathy-for-pain task, they rated their emotional reactions to pictures of individuals in pain. In the empathy accuracy task, they were asked to assess the feelings of videotaped individuals telling emotional stories.

They were then presented with two clinical scenarios: a female patient with a headache and a male patient with a backache. Following that, they were asked to assess the magnitude of the patients’ pain and how likely they would be to prescribe pain medication.

In the empathy-for-pain task, physicians’ empathy scores were significantly lower in the night shift group than in the day group (difference, –0.83; 95% CI, –1.55 to –0.10; P = .026). There were no significant differences between the groups in the empathy accuracy task.

In both scenarios, physicians in the night shift group assessed the patient’s pain as weaker in comparison with physicians in the day group. There was a statistically significant difference in the headache scenario but not the backache scenario.

Need for naps?

The researchers then analyzed analgesic prescription patterns drawn from three datasets of discharge notes of patients presenting to the emergency department with pain complaints (n = 13,482) at two branches of Hadassah-Hebrew University Medical Center and the University of Missouri Health Center.

The researchers collected data, including discharge time, medications patients were prescribed upon discharge, and patients’ subjective pain rating on a scale of 0-10 on a visual analogue scale (VAS).

Although patients’ VAS scores did not differ with respect to time or shift, patients were discharged with significantly less prescribed analgesics during the night shift in comparison with the day shift.

Compromised safety

In a comment, Eti Ben Simon, PhD, a postdoctoral fellow at the Center for Human Sleep Science, University of California, Berkeley, called the study “an important contribution to a growing list of studies that reveal how long night shifts reduce overall safety” for both patients and clinicians.

“It’s time to abandon the notion that the human brain can function as normal after being deprived of sleep for 24 hours,” said Dr. Ben Simon, who was not involved with the research.

“This is especially true in medicine, where we trust others to take care of us and feel our pain. These functions are simply not possible without adequate sleep,” she added.

Also commenting, Kannan Ramar, MD, president of the American Academy of Sleep Medicine, suggested that being cognizant of these findings “may help providers to mitigate this bias” of underprescribing pain medications when treating their patients.

Dr. Ramar, who is also a critical care specialist, pulmonologist, and sleep medicine specialist at Mayo Clinic, Rochester, Minn., was not involved with the research.

He noted that “further studies that systematically evaluate this further in a prospective and blinded way will be important.”

The research was supported in part by grants from the Israel Science Foundation, Joy Ventures, the Recanati Fund at the Jerusalem School of Business at the Hebrew University, and a fellowship from the Azrieli Foundation and received grant support to various investigators from the NIH, the Leda J. Sears Foundation, and the University of Missouri. The investigators, Ramar, and Ben Simon have reported no relevant financial relationships.

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

Physicians who are sleep deprived have less empathy for patients who report pain – and they prescribe fewer analgesics, new research suggests.

In the first of two studies, resident physicians were presented with two hypothetical scenarios involving a patient who complains of pain. They were asked about their likelihood of prescribing pain medication. The test was given to one group of residents who were just starting their day and to another group who were at the end of their night shift after being on call for 26 hours.

Results showed that the night shift residents were less likely than their daytime counterparts to say they would prescribe pain medication to the patients.

In further analysis of discharge notes from more than 13,000 electronic records of patients presenting with pain complaints at hospitals in Israel and the United States, the likelihood of an analgesic being prescribed during the night shift was 11% lower in Israel and 9% lower in the United States, compared with the day shift.

“Pain management is a major challenge, and a doctor’s perception of a patient’s subjective pain is susceptible to bias,” coinvestigator David Gozal, MD, the Marie M. and Harry L. Smith Endowed Chair of Child Health, University of Missouri–Columbia, said in a press release.

“This study demonstrated that night shift work is an important and previously unrecognized source of bias in pain management, likely stemming from impaired perception of pain,” Dr. Gozal added.

The findings were published online in the Proceedings of the National Academy of Sciences.
 

‘Directional’ differences

Senior investigator Alex Gileles-Hillel, MD, senior pediatric pulmonologist and sleep researcher at Hadassah University Medical Center, Jerusalem, said in an interview that physicians must make “complex assessments of patients’ subjective pain experience” – and the “subjective nature of pain management decisions can give rise to various biases.”

Dr. Gileles-Hillel has previously researched the cognitive toll of night shift work on physicians.

“It’s pretty established, for example, not to drive when sleep deprived because cognition is impaired,” he said. The current study explored whether sleep deprivation could affect areas other than cognition, including emotions and empathy.

The researchers used “two complementary approaches.” First, they administered tests to measure empathy and pain management decisions in 67 resident physicians at Hadassah Medical Centers either following a 26-hour night shift that began at 8:00 a.m. the day before (n = 36) or immediately before starting the workday (n = 31).

There were no significant differences in demographic, sleep, or burnout measures between the two groups, except that night shift physicians had slept less than those in the daytime group (2.93 vs. 5.96 hours).

Participants completed two tasks. In the empathy-for-pain task, they rated their emotional reactions to pictures of individuals in pain. In the empathy accuracy task, they were asked to assess the feelings of videotaped individuals telling emotional stories.

They were then presented with two clinical scenarios: a female patient with a headache and a male patient with a backache. Following that, they were asked to assess the magnitude of the patients’ pain and how likely they would be to prescribe pain medication.

In the empathy-for-pain task, physicians’ empathy scores were significantly lower in the night shift group than in the day group (difference, –0.83; 95% CI, –1.55 to –0.10; P = .026). There were no significant differences between the groups in the empathy accuracy task.

In both scenarios, physicians in the night shift group assessed the patient’s pain as weaker in comparison with physicians in the day group. There was a statistically significant difference in the headache scenario but not the backache scenario.

Need for naps?

The researchers then analyzed analgesic prescription patterns drawn from three datasets of discharge notes of patients presenting to the emergency department with pain complaints (n = 13,482) at two branches of Hadassah-Hebrew University Medical Center and the University of Missouri Health Center.

The researchers collected data, including discharge time, medications patients were prescribed upon discharge, and patients’ subjective pain rating on a scale of 0-10 on a visual analogue scale (VAS).

Although patients’ VAS scores did not differ with respect to time or shift, patients were discharged with significantly less prescribed analgesics during the night shift in comparison with the day shift.

Compromised safety

In a comment, Eti Ben Simon, PhD, a postdoctoral fellow at the Center for Human Sleep Science, University of California, Berkeley, called the study “an important contribution to a growing list of studies that reveal how long night shifts reduce overall safety” for both patients and clinicians.

“It’s time to abandon the notion that the human brain can function as normal after being deprived of sleep for 24 hours,” said Dr. Ben Simon, who was not involved with the research.

“This is especially true in medicine, where we trust others to take care of us and feel our pain. These functions are simply not possible without adequate sleep,” she added.

Also commenting, Kannan Ramar, MD, president of the American Academy of Sleep Medicine, suggested that being cognizant of these findings “may help providers to mitigate this bias” of underprescribing pain medications when treating their patients.

Dr. Ramar, who is also a critical care specialist, pulmonologist, and sleep medicine specialist at Mayo Clinic, Rochester, Minn., was not involved with the research.

He noted that “further studies that systematically evaluate this further in a prospective and blinded way will be important.”

The research was supported in part by grants from the Israel Science Foundation, Joy Ventures, the Recanati Fund at the Jerusalem School of Business at the Hebrew University, and a fellowship from the Azrieli Foundation and received grant support to various investigators from the NIH, the Leda J. Sears Foundation, and the University of Missouri. The investigators, Ramar, and Ben Simon have reported no relevant financial relationships.

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

Physicians who are sleep deprived have less empathy for patients who report pain – and they prescribe fewer analgesics, new research suggests.

In the first of two studies, resident physicians were presented with two hypothetical scenarios involving a patient who complains of pain. They were asked about their likelihood of prescribing pain medication. The test was given to one group of residents who were just starting their day and to another group who were at the end of their night shift after being on call for 26 hours.

Results showed that the night shift residents were less likely than their daytime counterparts to say they would prescribe pain medication to the patients.

In further analysis of discharge notes from more than 13,000 electronic records of patients presenting with pain complaints at hospitals in Israel and the United States, the likelihood of an analgesic being prescribed during the night shift was 11% lower in Israel and 9% lower in the United States, compared with the day shift.

“Pain management is a major challenge, and a doctor’s perception of a patient’s subjective pain is susceptible to bias,” coinvestigator David Gozal, MD, the Marie M. and Harry L. Smith Endowed Chair of Child Health, University of Missouri–Columbia, said in a press release.

“This study demonstrated that night shift work is an important and previously unrecognized source of bias in pain management, likely stemming from impaired perception of pain,” Dr. Gozal added.

The findings were published online in the Proceedings of the National Academy of Sciences.
 

‘Directional’ differences

Senior investigator Alex Gileles-Hillel, MD, senior pediatric pulmonologist and sleep researcher at Hadassah University Medical Center, Jerusalem, said in an interview that physicians must make “complex assessments of patients’ subjective pain experience” – and the “subjective nature of pain management decisions can give rise to various biases.”

Dr. Gileles-Hillel has previously researched the cognitive toll of night shift work on physicians.

“It’s pretty established, for example, not to drive when sleep deprived because cognition is impaired,” he said. The current study explored whether sleep deprivation could affect areas other than cognition, including emotions and empathy.

The researchers used “two complementary approaches.” First, they administered tests to measure empathy and pain management decisions in 67 resident physicians at Hadassah Medical Centers either following a 26-hour night shift that began at 8:00 a.m. the day before (n = 36) or immediately before starting the workday (n = 31).

There were no significant differences in demographic, sleep, or burnout measures between the two groups, except that night shift physicians had slept less than those in the daytime group (2.93 vs. 5.96 hours).

Participants completed two tasks. In the empathy-for-pain task, they rated their emotional reactions to pictures of individuals in pain. In the empathy accuracy task, they were asked to assess the feelings of videotaped individuals telling emotional stories.

They were then presented with two clinical scenarios: a female patient with a headache and a male patient with a backache. Following that, they were asked to assess the magnitude of the patients’ pain and how likely they would be to prescribe pain medication.

In the empathy-for-pain task, physicians’ empathy scores were significantly lower in the night shift group than in the day group (difference, –0.83; 95% CI, –1.55 to –0.10; P = .026). There were no significant differences between the groups in the empathy accuracy task.

In both scenarios, physicians in the night shift group assessed the patient’s pain as weaker in comparison with physicians in the day group. There was a statistically significant difference in the headache scenario but not the backache scenario.

Need for naps?

The researchers then analyzed analgesic prescription patterns drawn from three datasets of discharge notes of patients presenting to the emergency department with pain complaints (n = 13,482) at two branches of Hadassah-Hebrew University Medical Center and the University of Missouri Health Center.

The researchers collected data, including discharge time, medications patients were prescribed upon discharge, and patients’ subjective pain rating on a scale of 0-10 on a visual analogue scale (VAS).

Although patients’ VAS scores did not differ with respect to time or shift, patients were discharged with significantly less prescribed analgesics during the night shift in comparison with the day shift.

Compromised safety

In a comment, Eti Ben Simon, PhD, a postdoctoral fellow at the Center for Human Sleep Science, University of California, Berkeley, called the study “an important contribution to a growing list of studies that reveal how long night shifts reduce overall safety” for both patients and clinicians.

“It’s time to abandon the notion that the human brain can function as normal after being deprived of sleep for 24 hours,” said Dr. Ben Simon, who was not involved with the research.

“This is especially true in medicine, where we trust others to take care of us and feel our pain. These functions are simply not possible without adequate sleep,” she added.

Also commenting, Kannan Ramar, MD, president of the American Academy of Sleep Medicine, suggested that being cognizant of these findings “may help providers to mitigate this bias” of underprescribing pain medications when treating their patients.

Dr. Ramar, who is also a critical care specialist, pulmonologist, and sleep medicine specialist at Mayo Clinic, Rochester, Minn., was not involved with the research.

He noted that “further studies that systematically evaluate this further in a prospective and blinded way will be important.”

The research was supported in part by grants from the Israel Science Foundation, Joy Ventures, the Recanati Fund at the Jerusalem School of Business at the Hebrew University, and a fellowship from the Azrieli Foundation and received grant support to various investigators from the NIH, the Leda J. Sears Foundation, and the University of Missouri. The investigators, Ramar, and Ben Simon have reported no relevant financial relationships.

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

One to two times a week I go through my junk mail folder. Usually it’s a collection of, well, junk: ads for CME, office software, car warranties, gift cards, dating sites, eyeglass or razor sellers, etc.

But there are usually a few items I’m glad I found, ones that I’m not sure how they ended up there. Bank notifications, package-tracking updates, a few other things. By the same token, every day a few pieces of junk land in my inbox.

This is, however, what we do for a living in this job.

Some patients are straightforward. The story is clear, the plan obvious.

Some require a bit more thinking.

And some are all over the place. Histories that wander everywhere, a million symptoms and clues. Most are likely red herrings, but which ones isn’t immediately obvious. And it’s up to the doctor to work this out.

With my junk folder, though, it’s usually immediately obvious what the useless things are compared with those of value. In medicine it’s often not so simple. You have to be careful what you discard, and you always need to be ready to change your mind and backtrack.

Artificial intelligence gets better every year but still makes plenty of mistakes. In sorting email my computer has to work out the signal-to-noise ratio of incoming items and decide which ones mean something. If my junk folder is any indication, it still has a ways to go.

This isn’t to say I’m infallible. I’m not. Unlike the algorithms my email program uses, there are no definite rules in medical cases. Picking through the clues is something that comes with training, experience, and a bit of luck. When I realize I’m going in the wrong direction I have to step back and rethink it all.

A lot of chart systems try to incorporate algorithms into medical decision-making. Sometimes they’re helpful, such as pointing out a drug interaction I wasn’t aware of. At other times they’re not, telling me I shouldn’t be ordering a test because such-and-such criteria haven’t been met. The trouble is these algorithms are written to apply to all cases, even though every patient is different. Sometimes the best we can go on is what I call “spidey sense” – realizing that there’s more than meets the eye here. In 24 years it’s served me well, far better than any computer algorithm has.

People talk about a natural fear of being replaced by computers. I agree that there are some things they’re very good at, and they keep getting better. But medicine isn’t a one-size-fits-all field. And the consequences are a lot higher than those from my bank statement being overlooked for a few days.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

One to two times a week I go through my junk mail folder. Usually it’s a collection of, well, junk: ads for CME, office software, car warranties, gift cards, dating sites, eyeglass or razor sellers, etc.

But there are usually a few items I’m glad I found, ones that I’m not sure how they ended up there. Bank notifications, package-tracking updates, a few other things. By the same token, every day a few pieces of junk land in my inbox.

This is, however, what we do for a living in this job.

Some patients are straightforward. The story is clear, the plan obvious.

Some require a bit more thinking.

And some are all over the place. Histories that wander everywhere, a million symptoms and clues. Most are likely red herrings, but which ones isn’t immediately obvious. And it’s up to the doctor to work this out.

With my junk folder, though, it’s usually immediately obvious what the useless things are compared with those of value. In medicine it’s often not so simple. You have to be careful what you discard, and you always need to be ready to change your mind and backtrack.

Artificial intelligence gets better every year but still makes plenty of mistakes. In sorting email my computer has to work out the signal-to-noise ratio of incoming items and decide which ones mean something. If my junk folder is any indication, it still has a ways to go.

This isn’t to say I’m infallible. I’m not. Unlike the algorithms my email program uses, there are no definite rules in medical cases. Picking through the clues is something that comes with training, experience, and a bit of luck. When I realize I’m going in the wrong direction I have to step back and rethink it all.

A lot of chart systems try to incorporate algorithms into medical decision-making. Sometimes they’re helpful, such as pointing out a drug interaction I wasn’t aware of. At other times they’re not, telling me I shouldn’t be ordering a test because such-and-such criteria haven’t been met. The trouble is these algorithms are written to apply to all cases, even though every patient is different. Sometimes the best we can go on is what I call “spidey sense” – realizing that there’s more than meets the eye here. In 24 years it’s served me well, far better than any computer algorithm has.

People talk about a natural fear of being replaced by computers. I agree that there are some things they’re very good at, and they keep getting better. But medicine isn’t a one-size-fits-all field. And the consequences are a lot higher than those from my bank statement being overlooked for a few days.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

One to two times a week I go through my junk mail folder. Usually it’s a collection of, well, junk: ads for CME, office software, car warranties, gift cards, dating sites, eyeglass or razor sellers, etc.

But there are usually a few items I’m glad I found, ones that I’m not sure how they ended up there. Bank notifications, package-tracking updates, a few other things. By the same token, every day a few pieces of junk land in my inbox.

This is, however, what we do for a living in this job.

Some patients are straightforward. The story is clear, the plan obvious.

Some require a bit more thinking.

And some are all over the place. Histories that wander everywhere, a million symptoms and clues. Most are likely red herrings, but which ones isn’t immediately obvious. And it’s up to the doctor to work this out.

With my junk folder, though, it’s usually immediately obvious what the useless things are compared with those of value. In medicine it’s often not so simple. You have to be careful what you discard, and you always need to be ready to change your mind and backtrack.

Artificial intelligence gets better every year but still makes plenty of mistakes. In sorting email my computer has to work out the signal-to-noise ratio of incoming items and decide which ones mean something. If my junk folder is any indication, it still has a ways to go.

This isn’t to say I’m infallible. I’m not. Unlike the algorithms my email program uses, there are no definite rules in medical cases. Picking through the clues is something that comes with training, experience, and a bit of luck. When I realize I’m going in the wrong direction I have to step back and rethink it all.

A lot of chart systems try to incorporate algorithms into medical decision-making. Sometimes they’re helpful, such as pointing out a drug interaction I wasn’t aware of. At other times they’re not, telling me I shouldn’t be ordering a test because such-and-such criteria haven’t been met. The trouble is these algorithms are written to apply to all cases, even though every patient is different. Sometimes the best we can go on is what I call “spidey sense” – realizing that there’s more than meets the eye here. In 24 years it’s served me well, far better than any computer algorithm has.

People talk about a natural fear of being replaced by computers. I agree that there are some things they’re very good at, and they keep getting better. But medicine isn’t a one-size-fits-all field. And the consequences are a lot higher than those from my bank statement being overlooked for a few days.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

New risk thresholds used to guide statin therapy for primary prevention of atherosclerotic cardiovascular disease in the latest European guidelines dramatically reduce eligibility for statin use in low-risk countries, a new study has found.

The authors reported that new risk thresholds that were chosen for statin treatment in the 2021 European Society of Cardiology guidelines reduce statin eligibility to only 4% of the target population and essentially eliminate a statin indication in women.

“We have guidelines in place to try to prevent cardiovascular disease but the risk threshold in this new guideline means that almost nobody qualifies for treatment in many countries, which will lead to almost no prevention of future cardiovascular disease in those countries,” lead author Martin Bødtker Mortensen, MD, PhD, Aarhus (Denmark) University Hospital, commented in an interview.

“We argue that the risk thresholds need to be lowered to get the statin eligibility in European countries to be in line with thresholds in the U.K. and U.S., which are based on randomized, controlled trials,” he added.

The study was published online in JAMA Cardiology.

An accompanying editorial describes the results of the study as “alarming,” and, if confirmed, said the guidelines should be revisited to “prevent a step backwards in the use of statins in primary prevention.”

For the study, Dr. Mortensen and colleagues set out to compare the clinical performance of the new European prevention guidelines with American College of Cardiology/American Heart Association, United Kingdom–National Institute for Health and Care Excellence, and the 2019 European guidelines in a contemporary European cohort of 66,909 apparently healthy individuals from the Copenhagen General Population Study.

During the 9-year follow-up, a range of 2,962-4,277 nonfatal and fatal cardiovascular events was observed, as defined by the models in the various guidelines.

Results showed that although the new 2021 European guidelines introduced a new and improved risk model, known as SCORE2, the updated age-specific recommendations dramatically reduced eligibility for a class I recommendation for statin therapy to only 4% of individuals, aged 40-69 years, and less than 1% of women.

This is in sharp contrast to the previous 2019 European guidelines as well as current UK-NICE and US-ACC/AHA guidelines that provide class I/strong recommendations to 20%, 26%, and 34% of individuals, respectively, with better clinical performance in both men and women, the authors report.

The researchers also reported other analyses in which the sensitivity of the new European guidelines was improved considerably by lowering the treatment thresholds.

Dr. Mortensen explained to this news organization that the original SCORE risk model used in ESC guidelines was problematic as it only predicts the 10-year risk of fatal atherosclerotic cardiovascular events, whereas those from the United States and United Kingdom used both fatal and nonfatal cardiovascular events.

“Now the ESC has updated its model and the new model is much better in that it predicts both fatal and nonfatal events, and the predicted risk correlates well with the actual risk. So that’s a big step forward. However, the new thresholds for statin treatment are far too high for low-risk European countries because very few individuals will now qualify for statin therapy,” he said.

“The problem is that, if we use these guidelines, the vast majority of those individuals who will develop cardiovascular disease within 10 years will not be assigned statin therapy that can reduce this risk. There will be lots of individuals who are at high risk of cardiovascular disease, but these guidelines will not identify them as needing to take a statin,” Dr. Mortensen commented.

“If we use the U.K. or U.S. guidelines, far more people in these low-risk European countries would be eligible for statin therapy and we would prevent far more events than if we use the new ESC guidelines,” he added.

Dr. Mortensen explained that the problem arises from having four different risk score models in Europe for areas at different risk, but they all use the same risk thresholds for statin treatment.

“In general, Eastern European countries have higher risk than Western European countries, so these guidelines may work quite well in Eastern European countries but in low-risk Western European countries, where the low-risk score model is used, very few people will qualify for statin therapy,” he said.

While Dr. Mortensen is not against the idea of different risk models in areas that have different risks, he says this needs to be accompanied by different risk thresholds in the different risk areas.

Asked whether there is an argument that most individuals in low-risk countries may not need to take a statin, Dr. Mortensen countered: “One of the reasons the risk is low in many of these European countries is the high use of preventative medication. So, if a threshold that is too high is used most people will not take a statin anymore and the risk in these countries will increase again.”

Authors of the accompanying editorial, Ann Marie Navar, MD, PhD, University of Texas Southwestern Medical Center, Dallas; Gregg C. Fonarow, MD, University of California, Los Angeles; and Michael J. Pencina, PhD, Duke University Medical Center, Durham, N.C., agreed with Dr. Mortensen that the problems appear to arise from use of a risk score that is highly influenced by regional cardiovascular burden.

They point out that under the current guidelines, a 55-year-old woman (smoker; systolic blood pressure, 130 mm Hg; non–HDL cholesterol, 4.0 mmol/L) would have a 10-year predicted risk of having a cardiovascular event of 5% in Denmark but a predicted risk of 18% in Romania.

“While there may be regional differences in environmental risk factors, location alone should not cause a fourfold difference in an individual’s predicted cardiovascular risk,” they wrote.

The editorialists also elaborated on Dr. Mortensen’s point that the new guideline creates a system that eventually becomes a victim of its own success.

“As countries are successful in implementing statin therapy to lower CVD, CVD rates drop, and progressively fewer individuals are then eligible for the very therapy that contributed to the decline in CVD in the first place,” they noted.

The editorialists called for the analysis to be replicated in other low-risk countries and extended to higher-risk regions, with a focus on potential overtreatment of men and older adults.

“If confirmed, the present findings should be a catalyst for the ESC to revisit or augment their current guidelines to prevent a step backward in the use of statins in primary prevention,” they concluded.

This news organization asked the ESC for a response to the findings, but did not comment by press time.

This work was supported by the Lundbeck Foundation, Herlev and Gentofte Hospital, Copenhagen University Hospital, the Copenhagen County Foundation, and Aarhus University, Denmark. Dr. Mortensen reported no disclosures.

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

New risk thresholds used to guide statin therapy for primary prevention of atherosclerotic cardiovascular disease in the latest European guidelines dramatically reduce eligibility for statin use in low-risk countries, a new study has found.

The authors reported that new risk thresholds that were chosen for statin treatment in the 2021 European Society of Cardiology guidelines reduce statin eligibility to only 4% of the target population and essentially eliminate a statin indication in women.

“We have guidelines in place to try to prevent cardiovascular disease but the risk threshold in this new guideline means that almost nobody qualifies for treatment in many countries, which will lead to almost no prevention of future cardiovascular disease in those countries,” lead author Martin Bødtker Mortensen, MD, PhD, Aarhus (Denmark) University Hospital, commented in an interview.

“We argue that the risk thresholds need to be lowered to get the statin eligibility in European countries to be in line with thresholds in the U.K. and U.S., which are based on randomized, controlled trials,” he added.

The study was published online in JAMA Cardiology.

An accompanying editorial describes the results of the study as “alarming,” and, if confirmed, said the guidelines should be revisited to “prevent a step backwards in the use of statins in primary prevention.”

For the study, Dr. Mortensen and colleagues set out to compare the clinical performance of the new European prevention guidelines with American College of Cardiology/American Heart Association, United Kingdom–National Institute for Health and Care Excellence, and the 2019 European guidelines in a contemporary European cohort of 66,909 apparently healthy individuals from the Copenhagen General Population Study.

During the 9-year follow-up, a range of 2,962-4,277 nonfatal and fatal cardiovascular events was observed, as defined by the models in the various guidelines.

Results showed that although the new 2021 European guidelines introduced a new and improved risk model, known as SCORE2, the updated age-specific recommendations dramatically reduced eligibility for a class I recommendation for statin therapy to only 4% of individuals, aged 40-69 years, and less than 1% of women.

This is in sharp contrast to the previous 2019 European guidelines as well as current UK-NICE and US-ACC/AHA guidelines that provide class I/strong recommendations to 20%, 26%, and 34% of individuals, respectively, with better clinical performance in both men and women, the authors report.

The researchers also reported other analyses in which the sensitivity of the new European guidelines was improved considerably by lowering the treatment thresholds.

Dr. Mortensen explained to this news organization that the original SCORE risk model used in ESC guidelines was problematic as it only predicts the 10-year risk of fatal atherosclerotic cardiovascular events, whereas those from the United States and United Kingdom used both fatal and nonfatal cardiovascular events.

“Now the ESC has updated its model and the new model is much better in that it predicts both fatal and nonfatal events, and the predicted risk correlates well with the actual risk. So that’s a big step forward. However, the new thresholds for statin treatment are far too high for low-risk European countries because very few individuals will now qualify for statin therapy,” he said.

“The problem is that, if we use these guidelines, the vast majority of those individuals who will develop cardiovascular disease within 10 years will not be assigned statin therapy that can reduce this risk. There will be lots of individuals who are at high risk of cardiovascular disease, but these guidelines will not identify them as needing to take a statin,” Dr. Mortensen commented.

“If we use the U.K. or U.S. guidelines, far more people in these low-risk European countries would be eligible for statin therapy and we would prevent far more events than if we use the new ESC guidelines,” he added.

Dr. Mortensen explained that the problem arises from having four different risk score models in Europe for areas at different risk, but they all use the same risk thresholds for statin treatment.

“In general, Eastern European countries have higher risk than Western European countries, so these guidelines may work quite well in Eastern European countries but in low-risk Western European countries, where the low-risk score model is used, very few people will qualify for statin therapy,” he said.

While Dr. Mortensen is not against the idea of different risk models in areas that have different risks, he says this needs to be accompanied by different risk thresholds in the different risk areas.

Asked whether there is an argument that most individuals in low-risk countries may not need to take a statin, Dr. Mortensen countered: “One of the reasons the risk is low in many of these European countries is the high use of preventative medication. So, if a threshold that is too high is used most people will not take a statin anymore and the risk in these countries will increase again.”

Authors of the accompanying editorial, Ann Marie Navar, MD, PhD, University of Texas Southwestern Medical Center, Dallas; Gregg C. Fonarow, MD, University of California, Los Angeles; and Michael J. Pencina, PhD, Duke University Medical Center, Durham, N.C., agreed with Dr. Mortensen that the problems appear to arise from use of a risk score that is highly influenced by regional cardiovascular burden.

They point out that under the current guidelines, a 55-year-old woman (smoker; systolic blood pressure, 130 mm Hg; non–HDL cholesterol, 4.0 mmol/L) would have a 10-year predicted risk of having a cardiovascular event of 5% in Denmark but a predicted risk of 18% in Romania.

“While there may be regional differences in environmental risk factors, location alone should not cause a fourfold difference in an individual’s predicted cardiovascular risk,” they wrote.

The editorialists also elaborated on Dr. Mortensen’s point that the new guideline creates a system that eventually becomes a victim of its own success.

“As countries are successful in implementing statin therapy to lower CVD, CVD rates drop, and progressively fewer individuals are then eligible for the very therapy that contributed to the decline in CVD in the first place,” they noted.

The editorialists called for the analysis to be replicated in other low-risk countries and extended to higher-risk regions, with a focus on potential overtreatment of men and older adults.

“If confirmed, the present findings should be a catalyst for the ESC to revisit or augment their current guidelines to prevent a step backward in the use of statins in primary prevention,” they concluded.

This news organization asked the ESC for a response to the findings, but did not comment by press time.

This work was supported by the Lundbeck Foundation, Herlev and Gentofte Hospital, Copenhagen University Hospital, the Copenhagen County Foundation, and Aarhus University, Denmark. Dr. Mortensen reported no disclosures.

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

New risk thresholds used to guide statin therapy for primary prevention of atherosclerotic cardiovascular disease in the latest European guidelines dramatically reduce eligibility for statin use in low-risk countries, a new study has found.

The authors reported that new risk thresholds that were chosen for statin treatment in the 2021 European Society of Cardiology guidelines reduce statin eligibility to only 4% of the target population and essentially eliminate a statin indication in women.

“We have guidelines in place to try to prevent cardiovascular disease but the risk threshold in this new guideline means that almost nobody qualifies for treatment in many countries, which will lead to almost no prevention of future cardiovascular disease in those countries,” lead author Martin Bødtker Mortensen, MD, PhD, Aarhus (Denmark) University Hospital, commented in an interview.

“We argue that the risk thresholds need to be lowered to get the statin eligibility in European countries to be in line with thresholds in the U.K. and U.S., which are based on randomized, controlled trials,” he added.

The study was published online in JAMA Cardiology.

An accompanying editorial describes the results of the study as “alarming,” and, if confirmed, said the guidelines should be revisited to “prevent a step backwards in the use of statins in primary prevention.”

For the study, Dr. Mortensen and colleagues set out to compare the clinical performance of the new European prevention guidelines with American College of Cardiology/American Heart Association, United Kingdom–National Institute for Health and Care Excellence, and the 2019 European guidelines in a contemporary European cohort of 66,909 apparently healthy individuals from the Copenhagen General Population Study.

During the 9-year follow-up, a range of 2,962-4,277 nonfatal and fatal cardiovascular events was observed, as defined by the models in the various guidelines.

Results showed that although the new 2021 European guidelines introduced a new and improved risk model, known as SCORE2, the updated age-specific recommendations dramatically reduced eligibility for a class I recommendation for statin therapy to only 4% of individuals, aged 40-69 years, and less than 1% of women.

This is in sharp contrast to the previous 2019 European guidelines as well as current UK-NICE and US-ACC/AHA guidelines that provide class I/strong recommendations to 20%, 26%, and 34% of individuals, respectively, with better clinical performance in both men and women, the authors report.

The researchers also reported other analyses in which the sensitivity of the new European guidelines was improved considerably by lowering the treatment thresholds.

Dr. Mortensen explained to this news organization that the original SCORE risk model used in ESC guidelines was problematic as it only predicts the 10-year risk of fatal atherosclerotic cardiovascular events, whereas those from the United States and United Kingdom used both fatal and nonfatal cardiovascular events.

“Now the ESC has updated its model and the new model is much better in that it predicts both fatal and nonfatal events, and the predicted risk correlates well with the actual risk. So that’s a big step forward. However, the new thresholds for statin treatment are far too high for low-risk European countries because very few individuals will now qualify for statin therapy,” he said.

“The problem is that, if we use these guidelines, the vast majority of those individuals who will develop cardiovascular disease within 10 years will not be assigned statin therapy that can reduce this risk. There will be lots of individuals who are at high risk of cardiovascular disease, but these guidelines will not identify them as needing to take a statin,” Dr. Mortensen commented.

“If we use the U.K. or U.S. guidelines, far more people in these low-risk European countries would be eligible for statin therapy and we would prevent far more events than if we use the new ESC guidelines,” he added.

Dr. Mortensen explained that the problem arises from having four different risk score models in Europe for areas at different risk, but they all use the same risk thresholds for statin treatment.

“In general, Eastern European countries have higher risk than Western European countries, so these guidelines may work quite well in Eastern European countries but in low-risk Western European countries, where the low-risk score model is used, very few people will qualify for statin therapy,” he said.

While Dr. Mortensen is not against the idea of different risk models in areas that have different risks, he says this needs to be accompanied by different risk thresholds in the different risk areas.

Asked whether there is an argument that most individuals in low-risk countries may not need to take a statin, Dr. Mortensen countered: “One of the reasons the risk is low in many of these European countries is the high use of preventative medication. So, if a threshold that is too high is used most people will not take a statin anymore and the risk in these countries will increase again.”

Authors of the accompanying editorial, Ann Marie Navar, MD, PhD, University of Texas Southwestern Medical Center, Dallas; Gregg C. Fonarow, MD, University of California, Los Angeles; and Michael J. Pencina, PhD, Duke University Medical Center, Durham, N.C., agreed with Dr. Mortensen that the problems appear to arise from use of a risk score that is highly influenced by regional cardiovascular burden.

They point out that under the current guidelines, a 55-year-old woman (smoker; systolic blood pressure, 130 mm Hg; non–HDL cholesterol, 4.0 mmol/L) would have a 10-year predicted risk of having a cardiovascular event of 5% in Denmark but a predicted risk of 18% in Romania.

“While there may be regional differences in environmental risk factors, location alone should not cause a fourfold difference in an individual’s predicted cardiovascular risk,” they wrote.

The editorialists also elaborated on Dr. Mortensen’s point that the new guideline creates a system that eventually becomes a victim of its own success.

“As countries are successful in implementing statin therapy to lower CVD, CVD rates drop, and progressively fewer individuals are then eligible for the very therapy that contributed to the decline in CVD in the first place,” they noted.

The editorialists called for the analysis to be replicated in other low-risk countries and extended to higher-risk regions, with a focus on potential overtreatment of men and older adults.

“If confirmed, the present findings should be a catalyst for the ESC to revisit or augment their current guidelines to prevent a step backward in the use of statins in primary prevention,” they concluded.

This news organization asked the ESC for a response to the findings, but did not comment by press time.

This work was supported by the Lundbeck Foundation, Herlev and Gentofte Hospital, Copenhagen University Hospital, the Copenhagen County Foundation, and Aarhus University, Denmark. Dr. Mortensen reported no disclosures.

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

Children who regularly slept 10-plus hours per night, particularly just before starting kindergarten, transitioned more successfully to kindergarten than those with less regular sleeping patterns, an observational study found. The effect held across the kindergarten year regardless of socioeconomic and health covariates, according to a new study by Douglas M. Teti, PhD, a developmental scientist and a professor of pediatrics at Penn State University, University Park, and colleagues.

“These effects were ubiquitous, extending to socioemotional learning engagement and academic domains,” they wrote online in Pediatrics

Furthermore, it was the regularity of sufficient nocturnal sleep that appeared to be more important for school adjustment than overall amounts of sleep accumulated across the day or the proportion of 24-hour periods in which children got 10 or more hours of sleep.

The American Academy of Sleep Medicine has recommended that 3- to 5-year-olds get 10-13 hours of sleep per day, including naps.

The findings by Dr. Teti’s group suggest that family-based interventions to establish consistent patterns of sufficient nighttime sleep should begin 5 or 6 months before the start of kindergarten.

“The importance of sleep as a predictor of school functioning in children is well-established, but relatively less is known about how sleep impacts children as they make their first transition into formal schooling,” Dr. Teti told this news organization. “School readiness and adjustment can be impacted by many factors, including socioeconomic status, child health, and missed days of school, but few studies have isolated the role of sleep in the transition to kindergarten net of these other influences, and few studies have examined the role that sleep plays on children’s school functioning throughout the full kindergarten year.”
 

The study

During 2016-2019, the researcher recruited 230 families from three Pennsylvania school districts, of which 221 completed the study. At several time points, the study examined three different measures of child sleep duration in 7-day bursts: at pre-kindergarten (July to August), early kindergarten (late September), mid-kindergarten (late November), and late kindergarten (mid-to-late April), using wrist actigraphy. These measures included:

• mean amounts of child sleep per 24-hour period across the full week
• proportion of 24-hour periods per week that children slept 10 or more hours
• proportion of nighttime sleep periods per week that children slept 10 or more hours

Outcomes at the designated school year time points were provided by 64 teachers blinded to the pupils’ sleep histories and by assessments administered by project staff.

Among the sleep measures examined, regularity of nighttime sleep involving 10 or more hours of sleep over the nocturnal period, especially at the pre-kindergarten stage, consistently predicted more favorable outcomes in socioemotional, learning engagement, and academic domains. These findings were controlled for income-to-poverty threshold ratios, child health status, and number of missed school days.

The study results generally align with those of previous studies, showing the importance of sleep for children’s school functioning, Dr. Teti told this news organization. “But they differed significantly in terms of finding that it was the regularity of 10-plus hours concentrated during the nighttime sleep period that was most important for predicting school adjustment, in particular, regular or sufficient sleep that occurred prior to the start of kindergarten.”

Calling the study “thought provoking,” Michael B. Grosso, MD, chair of pediatrics at Huntington (N.Y.) Hospital, said it confirms a robust correlation between total sleep duration and outcomes important to successful adjustment to kindergarten. “And we find out that uninterrupted sleep time of 10 hours or more seems to matter as well.”

In his view, the biggest limitation to the analysis is the one inherent to any observational study, “which is that association cannot prove causality. The authors did attempt to control for other health factors, but that can be hard to do,” he said. “The point is that if a child faces any of several health challenges, from sleep apnea to uncontrolled asthma, to ADHD or an autistic spectrum disorder, those issues will cause disrupted, abnormal sleep and also interfere with the outcomes the study addresses. In other words, it’s hard to know if sleep is affecting kindergarten adjustment or whether some X factor is affecting sleep and also affecting kindergarten performance.”

Getting children into bed earlier in long bright evenings of spring and summer before onset of kindergarten may not be easy, Dr. Teti acknowledged. “Arranging children’s sleep schedule as they approach kindergarten so that most, if not all, of their sleep takes place during the night – and as a corollary, reducing the frequency of naps during the day – should help children shift into sleeping nighttime primarily if not exclusively,” he said.

If necessary, he added, parents can work with sleep professionals to gradually concentrate children’s sleep during the night. They should normalize earlier bedtimes by reducing access to electronic screens before bedtime and removing televisions from their bedrooms. “A consistent bedtime routine should be a central feature of parental attempts to shape better, more regular sleep in their children.”

Dr. Grosso added that pediatricians need to talk about the importance of consistent routines and especially adequate sleep when counseling parents during pre-school health supervision visits. “And as the authors mention, it’s hard to ensure good sleep hygiene for children if parents aren’t also getting a good night sleep. It all goes together.”

This study was supported by the National Institutes of Health. The authors had no competing interests to declare. Dr. Grosso disclosed no relevant conflicts of interest.

Children who regularly slept 10-plus hours per night, particularly just before starting kindergarten, transitioned more successfully to kindergarten than those with less regular sleeping patterns, an observational study found. The effect held across the kindergarten year regardless of socioeconomic and health covariates, according to a new study by Douglas M. Teti, PhD, a developmental scientist and a professor of pediatrics at Penn State University, University Park, and colleagues.

“These effects were ubiquitous, extending to socioemotional learning engagement and academic domains,” they wrote online in Pediatrics

Furthermore, it was the regularity of sufficient nocturnal sleep that appeared to be more important for school adjustment than overall amounts of sleep accumulated across the day or the proportion of 24-hour periods in which children got 10 or more hours of sleep.

The American Academy of Sleep Medicine has recommended that 3- to 5-year-olds get 10-13 hours of sleep per day, including naps.

The findings by Dr. Teti’s group suggest that family-based interventions to establish consistent patterns of sufficient nighttime sleep should begin 5 or 6 months before the start of kindergarten.

“The importance of sleep as a predictor of school functioning in children is well-established, but relatively less is known about how sleep impacts children as they make their first transition into formal schooling,” Dr. Teti told this news organization. “School readiness and adjustment can be impacted by many factors, including socioeconomic status, child health, and missed days of school, but few studies have isolated the role of sleep in the transition to kindergarten net of these other influences, and few studies have examined the role that sleep plays on children’s school functioning throughout the full kindergarten year.”
 

The study

During 2016-2019, the researcher recruited 230 families from three Pennsylvania school districts, of which 221 completed the study. At several time points, the study examined three different measures of child sleep duration in 7-day bursts: at pre-kindergarten (July to August), early kindergarten (late September), mid-kindergarten (late November), and late kindergarten (mid-to-late April), using wrist actigraphy. These measures included:

• mean amounts of child sleep per 24-hour period across the full week
• proportion of 24-hour periods per week that children slept 10 or more hours
• proportion of nighttime sleep periods per week that children slept 10 or more hours

Outcomes at the designated school year time points were provided by 64 teachers blinded to the pupils’ sleep histories and by assessments administered by project staff.

Among the sleep measures examined, regularity of nighttime sleep involving 10 or more hours of sleep over the nocturnal period, especially at the pre-kindergarten stage, consistently predicted more favorable outcomes in socioemotional, learning engagement, and academic domains. These findings were controlled for income-to-poverty threshold ratios, child health status, and number of missed school days.

The study results generally align with those of previous studies, showing the importance of sleep for children’s school functioning, Dr. Teti told this news organization. “But they differed significantly in terms of finding that it was the regularity of 10-plus hours concentrated during the nighttime sleep period that was most important for predicting school adjustment, in particular, regular or sufficient sleep that occurred prior to the start of kindergarten.”

Calling the study “thought provoking,” Michael B. Grosso, MD, chair of pediatrics at Huntington (N.Y.) Hospital, said it confirms a robust correlation between total sleep duration and outcomes important to successful adjustment to kindergarten. “And we find out that uninterrupted sleep time of 10 hours or more seems to matter as well.”

In his view, the biggest limitation to the analysis is the one inherent to any observational study, “which is that association cannot prove causality. The authors did attempt to control for other health factors, but that can be hard to do,” he said. “The point is that if a child faces any of several health challenges, from sleep apnea to uncontrolled asthma, to ADHD or an autistic spectrum disorder, those issues will cause disrupted, abnormal sleep and also interfere with the outcomes the study addresses. In other words, it’s hard to know if sleep is affecting kindergarten adjustment or whether some X factor is affecting sleep and also affecting kindergarten performance.”

Getting children into bed earlier in long bright evenings of spring and summer before onset of kindergarten may not be easy, Dr. Teti acknowledged. “Arranging children’s sleep schedule as they approach kindergarten so that most, if not all, of their sleep takes place during the night – and as a corollary, reducing the frequency of naps during the day – should help children shift into sleeping nighttime primarily if not exclusively,” he said.

If necessary, he added, parents can work with sleep professionals to gradually concentrate children’s sleep during the night. They should normalize earlier bedtimes by reducing access to electronic screens before bedtime and removing televisions from their bedrooms. “A consistent bedtime routine should be a central feature of parental attempts to shape better, more regular sleep in their children.”

Dr. Grosso added that pediatricians need to talk about the importance of consistent routines and especially adequate sleep when counseling parents during pre-school health supervision visits. “And as the authors mention, it’s hard to ensure good sleep hygiene for children if parents aren’t also getting a good night sleep. It all goes together.”

This study was supported by the National Institutes of Health. The authors had no competing interests to declare. Dr. Grosso disclosed no relevant conflicts of interest.

Children who regularly slept 10-plus hours per night, particularly just before starting kindergarten, transitioned more successfully to kindergarten than those with less regular sleeping patterns, an observational study found. The effect held across the kindergarten year regardless of socioeconomic and health covariates, according to a new study by Douglas M. Teti, PhD, a developmental scientist and a professor of pediatrics at Penn State University, University Park, and colleagues.

“These effects were ubiquitous, extending to socioemotional learning engagement and academic domains,” they wrote online in Pediatrics

Furthermore, it was the regularity of sufficient nocturnal sleep that appeared to be more important for school adjustment than overall amounts of sleep accumulated across the day or the proportion of 24-hour periods in which children got 10 or more hours of sleep.

The American Academy of Sleep Medicine has recommended that 3- to 5-year-olds get 10-13 hours of sleep per day, including naps.

The findings by Dr. Teti’s group suggest that family-based interventions to establish consistent patterns of sufficient nighttime sleep should begin 5 or 6 months before the start of kindergarten.

“The importance of sleep as a predictor of school functioning in children is well-established, but relatively less is known about how sleep impacts children as they make their first transition into formal schooling,” Dr. Teti told this news organization. “School readiness and adjustment can be impacted by many factors, including socioeconomic status, child health, and missed days of school, but few studies have isolated the role of sleep in the transition to kindergarten net of these other influences, and few studies have examined the role that sleep plays on children’s school functioning throughout the full kindergarten year.”
 

The study

During 2016-2019, the researcher recruited 230 families from three Pennsylvania school districts, of which 221 completed the study. At several time points, the study examined three different measures of child sleep duration in 7-day bursts: at pre-kindergarten (July to August), early kindergarten (late September), mid-kindergarten (late November), and late kindergarten (mid-to-late April), using wrist actigraphy. These measures included:

• mean amounts of child sleep per 24-hour period across the full week
• proportion of 24-hour periods per week that children slept 10 or more hours
• proportion of nighttime sleep periods per week that children slept 10 or more hours

Outcomes at the designated school year time points were provided by 64 teachers blinded to the pupils’ sleep histories and by assessments administered by project staff.

Among the sleep measures examined, regularity of nighttime sleep involving 10 or more hours of sleep over the nocturnal period, especially at the pre-kindergarten stage, consistently predicted more favorable outcomes in socioemotional, learning engagement, and academic domains. These findings were controlled for income-to-poverty threshold ratios, child health status, and number of missed school days.

The study results generally align with those of previous studies, showing the importance of sleep for children’s school functioning, Dr. Teti told this news organization. “But they differed significantly in terms of finding that it was the regularity of 10-plus hours concentrated during the nighttime sleep period that was most important for predicting school adjustment, in particular, regular or sufficient sleep that occurred prior to the start of kindergarten.”

Calling the study “thought provoking,” Michael B. Grosso, MD, chair of pediatrics at Huntington (N.Y.) Hospital, said it confirms a robust correlation between total sleep duration and outcomes important to successful adjustment to kindergarten. “And we find out that uninterrupted sleep time of 10 hours or more seems to matter as well.”

In his view, the biggest limitation to the analysis is the one inherent to any observational study, “which is that association cannot prove causality. The authors did attempt to control for other health factors, but that can be hard to do,” he said. “The point is that if a child faces any of several health challenges, from sleep apnea to uncontrolled asthma, to ADHD or an autistic spectrum disorder, those issues will cause disrupted, abnormal sleep and also interfere with the outcomes the study addresses. In other words, it’s hard to know if sleep is affecting kindergarten adjustment or whether some X factor is affecting sleep and also affecting kindergarten performance.”

Getting children into bed earlier in long bright evenings of spring and summer before onset of kindergarten may not be easy, Dr. Teti acknowledged. “Arranging children’s sleep schedule as they approach kindergarten so that most, if not all, of their sleep takes place during the night – and as a corollary, reducing the frequency of naps during the day – should help children shift into sleeping nighttime primarily if not exclusively,” he said.

If necessary, he added, parents can work with sleep professionals to gradually concentrate children’s sleep during the night. They should normalize earlier bedtimes by reducing access to electronic screens before bedtime and removing televisions from their bedrooms. “A consistent bedtime routine should be a central feature of parental attempts to shape better, more regular sleep in their children.”

Dr. Grosso added that pediatricians need to talk about the importance of consistent routines and especially adequate sleep when counseling parents during pre-school health supervision visits. “And as the authors mention, it’s hard to ensure good sleep hygiene for children if parents aren’t also getting a good night sleep. It all goes together.”

This study was supported by the National Institutes of Health. The authors had no competing interests to declare. Dr. Grosso disclosed no relevant conflicts of interest.

California Gov. Gavin Newsom says the state government will manufacture its own low-cost insulin to make the drug more affordable for residents.

On July 7, he said he had just signed a state budget that includes $50 million for development of the insulin and another $50 million for a place to make it.

“Nothing, nothing epitomizes market failures more than the cost of insulin,” Gov. Newsom said in a video posted on the governor’s Twitter page. He noted that many Americans have out-of-pocket costs ranging from $300 to $500 per month for insulin, which is used to treat diabetes.

“In California, we know people should not go into debt to receive lifesaving medication,” he said.

Gov. Newsom said that when he first took office, he signed an executive order to launch California’s own prescription drug system and that the insulin initiative is the first step toward making that happen.

People who take insulin have long complained about its high price. A November 2021 report from The Lancet said 25% of the insulin patients in the United States struggle to pay for it.

The cost of insulin for patients with insurance ranges from $334 to $1,000 a month, ABC News said, citing the Kaiser Family Foundation.

Legislation in Congress would bring down the cost of insulin if passed, with one bill capping costs at $35 per month for patients with health insurance. But The Hill reported that some Republicans oppose the legislation because it would interfere with free markets and raise costs for drug companies.

The CDC says 37.3 million people in the United States – about 11.3% of the population – have diabetes, with 8.5 million of them undiagnosed.

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

California Gov. Gavin Newsom says the state government will manufacture its own low-cost insulin to make the drug more affordable for residents.

On July 7, he said he had just signed a state budget that includes $50 million for development of the insulin and another $50 million for a place to make it.

“Nothing, nothing epitomizes market failures more than the cost of insulin,” Gov. Newsom said in a video posted on the governor’s Twitter page. He noted that many Americans have out-of-pocket costs ranging from $300 to $500 per month for insulin, which is used to treat diabetes.

“In California, we know people should not go into debt to receive lifesaving medication,” he said.

Gov. Newsom said that when he first took office, he signed an executive order to launch California’s own prescription drug system and that the insulin initiative is the first step toward making that happen.

People who take insulin have long complained about its high price. A November 2021 report from The Lancet said 25% of the insulin patients in the United States struggle to pay for it.

The cost of insulin for patients with insurance ranges from $334 to $1,000 a month, ABC News said, citing the Kaiser Family Foundation.

Legislation in Congress would bring down the cost of insulin if passed, with one bill capping costs at $35 per month for patients with health insurance. But The Hill reported that some Republicans oppose the legislation because it would interfere with free markets and raise costs for drug companies.

The CDC says 37.3 million people in the United States – about 11.3% of the population – have diabetes, with 8.5 million of them undiagnosed.

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

California Gov. Gavin Newsom says the state government will manufacture its own low-cost insulin to make the drug more affordable for residents.

On July 7, he said he had just signed a state budget that includes $50 million for development of the insulin and another $50 million for a place to make it.

“Nothing, nothing epitomizes market failures more than the cost of insulin,” Gov. Newsom said in a video posted on the governor’s Twitter page. He noted that many Americans have out-of-pocket costs ranging from $300 to $500 per month for insulin, which is used to treat diabetes.

“In California, we know people should not go into debt to receive lifesaving medication,” he said.

Gov. Newsom said that when he first took office, he signed an executive order to launch California’s own prescription drug system and that the insulin initiative is the first step toward making that happen.

People who take insulin have long complained about its high price. A November 2021 report from The Lancet said 25% of the insulin patients in the United States struggle to pay for it.

The cost of insulin for patients with insurance ranges from $334 to $1,000 a month, ABC News said, citing the Kaiser Family Foundation.

Legislation in Congress would bring down the cost of insulin if passed, with one bill capping costs at $35 per month for patients with health insurance. But The Hill reported that some Republicans oppose the legislation because it would interfere with free markets and raise costs for drug companies.

The CDC says 37.3 million people in the United States – about 11.3% of the population – have diabetes, with 8.5 million of them undiagnosed.

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

Stephen Pribut, DPM, a sports medicine podiatrist based in Washington, has had many friends or family members ask him for medical advice. It’s a scenario every doctor will face at one point or another in their careers, and it’s never an easy one.

Dr. Pribut received a call from a friend about a sore shoulder from swimming, saying that his doctor had dismissed the potential for a rotator cuff injury. “Months later, images revealed it was a rotator cuff tear and he wanted my advice,” says Dr. Pribut.

Not being a shoulder specialist, Dr. Pribut limited his input. “I told him to consider a good physical therapist or a shoulder specialist and gave him some alternative strokes for swimming that hopefully wouldn’t aggravate the injury,” he explains.

But he admits some situations are challenging. “I had a relative asking about a third party with an ankle injury. I advised he hold off on using a balance board until things healed, and to make sure he went to see a specialist. Unfortunately, he went to his general practitioner who likely knows nothing about ankle anatomy,” says Dr. Pribut.

“I finally saw a photo, which revealed swelling higher up on the ankle and no evidence of a hematoma – much lower than we would see in an ankle ligament injury. I would like him to see a sports podiatrist or foot and ankle orthopedist, but now I have to stay calm when the advice isn’t followed,” he says.

Most doctors deal with the “curbside consult,” many times over, and most, according to a recent Medscape survey, will dole it out. When asked, “Do you give medical advice to your friends?” 96% of respondents answered yes.

Yazan Abou-Ismail, MD, assistant professor of medicine in the division of hematology at the University of Utah, Salt Lake City, has often faced questions from friends and family, particularly throughout the COVID-19 pandemic. “How you respond is something all physicians need to analyze carefully,” he says. “I get questions on a regular basis, but this greatly increased with COVID.”

“Sharing general information is okay, and it’s even a requirement that we educate on such topics,” says Dr. Abou-Ismail. “But if someone knows they have COVID, for instance, and wants advice on how to proceed, it’s important to send them to their primary care physician for an evaluation rather than give them instructions on care.”

Dr. Abou-Ismail says that most “curbside consulting” equates to lack of an ethical follow-up. “If you gave medical advice without having assessed them, you’re lacking the medical history, a physical exam, and you should not be giving advice,” he says. “This applies to follow-ups, too.”

Throughout the pandemic, Dr. Abou-Ismail’s requests for advice on COVID even extended to online inquiries, often from strangers. “This is not a place to do a formal assessment,” he reminds. “But there are certain types of advice you can offer appropriately.”

Dr. Abou-Ismail considers safe advice to be simple public health messages that stay far out of specifics. Things like “don’t smoke,” or “eat a healthy diet,” and “get enough sleep,” fall into this safety zone. Even, “What is XYZ disease?” or “How do COVID vaccines work?” are topics he says he answers comfortably.

“But telling someone you need a specific treatment for a condition is inappropriate,” he explains. “This is a general way of practicing medicine – your advice should never venture into the potential of doing harm.”

This approach is exactly in line with legal advice, according to Jeff Caesar Chukwuma, founder and senior partner at Chukwuma Law Group, Miami. “It doesn’t mean that doctors should never give medical advice to friends or family, but if they do, they should make sure to take several precautions to protect both themselves and their family and friends,” he says.

When the request for medical advice from an acquaintance migrates into areas in which a physician is not a specialist, sharing recommendations gets even trickier – and more ethically questionable.  

Says Mr. Chukwuma, “Doctors should avoid giving advice in areas outside their area of expertise to lower the possibility of providing erroneous or harmful information,” he says.

How to stay safe when asked for advice

The American Medical Association has weighed in on the topic. In the Code of Medical Ethics Opinion 1.2.1, the AMA states that, “Treating oneself or a member of one’s own family poses several challenges for physicians, including concerns about professional objectivity, patient autonomy, and informed consent.”

What about friends or acquaintances, however?

Even so, some respondents voiced their concerns with the scenario. Responses like, “Due to ethics, I would prefer they go and get first, second, and third opinions,” and “Usually the medical advice is very basic first aid (often mental health first aid), and if it’s anything remotely more complicated, I direct them to the appropriate provider.”

The AMA places advising friends in the same basket as advising and treating family members or oneself. In an article appearing in the AMA Journal of Ethics, Horacio Hojman, MD, of Tufts University School of Medicine, Boston, weighed in: “First and foremost, patients deserve objectivity from their doctors. When a physician is emotionally involved with a patient, that physician’s objectivity can be called into question.”

Why is medical advice so thorny when dealing with friends or relatives?

In some cases, a physician might not ask a friend relevant personal questions about his or her medical history, for instance. Or the friend might not want to share details with the doctor. In either case, the lack of information exchange can lead to improper advice.

The issue of giving medical advice to friends, family, and acquaintances can also wade into legal territory. “Personally or professionally, trust is the decisive factor that puts us at ease with the people we surround ourselves with,” says Mr. Chukwuma. “Nowhere is this truer than in medicine, where we approach doctors with some of the most sensitive matters in our lives and entrust our care to them, especially when the physician in question is a close friend or family member.”

Mr. Chukwuma points out that, while there are few strict legal prohibitions against doctors providing care or advice to family and friends, the AMA’s code of ethics states that such action should be reserved for rare situations, such as emergency settings or isolated settings where there is no other qualified physician available, or for minor, not long-term problems.

This was part of the equation for Dr. Pribut when helping his mother navigate her treatment for breast cancer. “With close relatives, offering advice and help can be very hard,” he says.

“This is to protect both patients and doctors,” says Mr. Chukwuma. “Although seeking advice from a family member or friend who is a doctor may be more convenient for a patient, they run the risk of receiving inadequate care by not going in for a formal medical visit complete with tests, medical examination, and follow-up care.”

Mr. Chukwuma offers guidance on how to share medical advice ethically and legally with family, friends, and acquaintances. “First, as much as possible, speak to general medical facts and knowledge rather than comment directly on the patient’s particular situation,” he says. “In the absence of thorough examination and tests, the doctor’s knowledge of a patient’s condition is limited, therefore, you should take care not to provide seemingly definitive answers on that patient’s unique condition in situations where they can’t rely on data to back up their advice and recommendations.”

The AMA’s Journal of Ethics article shares these tips for staying on the right side of the ethical line when dealing with friends and family members:

• Politely decline.
• Offer other forms of assistance – this might help a friend find the right qualified physician – as Dr. Pribut tends to do. Maybe help in navigating the sometimes-confusing health care system.
• Don’t hesitate in an emergency – the old “is there a doctor on board,” scenario on a plane when someone is in distress is a perfectly acceptable, and recommended, time to step in, even if it is a friend or family member.

Dr. Pribut, a long-time veteran of the tricky medical waters involving friends and family, has this to offer: “Be cautious and always stay in the realm of what you know,” he says. “Always encourage people to seek an opinion from a qualified doctor. Help them find a reputable doctor if that’s useful.”

Mr. Chukwuma adds also that doctors should stand firm when pushed by a friend or family member, especially when offering advice, even if it’s in the form of general education. “The doctor should make it clear to the family member or friend that their advice in no way takes the place of actual treatment or examination by a medical professional and that, if need be, the patient should seek formal medical help from another doctor, ideally one not related to or friends with the patient,” he says.

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

Stephen Pribut, DPM, a sports medicine podiatrist based in Washington, has had many friends or family members ask him for medical advice. It’s a scenario every doctor will face at one point or another in their careers, and it’s never an easy one.

Dr. Pribut received a call from a friend about a sore shoulder from swimming, saying that his doctor had dismissed the potential for a rotator cuff injury. “Months later, images revealed it was a rotator cuff tear and he wanted my advice,” says Dr. Pribut.

Not being a shoulder specialist, Dr. Pribut limited his input. “I told him to consider a good physical therapist or a shoulder specialist and gave him some alternative strokes for swimming that hopefully wouldn’t aggravate the injury,” he explains.

But he admits some situations are challenging. “I had a relative asking about a third party with an ankle injury. I advised he hold off on using a balance board until things healed, and to make sure he went to see a specialist. Unfortunately, he went to his general practitioner who likely knows nothing about ankle anatomy,” says Dr. Pribut.

“I finally saw a photo, which revealed swelling higher up on the ankle and no evidence of a hematoma – much lower than we would see in an ankle ligament injury. I would like him to see a sports podiatrist or foot and ankle orthopedist, but now I have to stay calm when the advice isn’t followed,” he says.

Most doctors deal with the “curbside consult,” many times over, and most, according to a recent Medscape survey, will dole it out. When asked, “Do you give medical advice to your friends?” 96% of respondents answered yes.

Yazan Abou-Ismail, MD, assistant professor of medicine in the division of hematology at the University of Utah, Salt Lake City, has often faced questions from friends and family, particularly throughout the COVID-19 pandemic. “How you respond is something all physicians need to analyze carefully,” he says. “I get questions on a regular basis, but this greatly increased with COVID.”

“Sharing general information is okay, and it’s even a requirement that we educate on such topics,” says Dr. Abou-Ismail. “But if someone knows they have COVID, for instance, and wants advice on how to proceed, it’s important to send them to their primary care physician for an evaluation rather than give them instructions on care.”

Dr. Abou-Ismail says that most “curbside consulting” equates to lack of an ethical follow-up. “If you gave medical advice without having assessed them, you’re lacking the medical history, a physical exam, and you should not be giving advice,” he says. “This applies to follow-ups, too.”

Throughout the pandemic, Dr. Abou-Ismail’s requests for advice on COVID even extended to online inquiries, often from strangers. “This is not a place to do a formal assessment,” he reminds. “But there are certain types of advice you can offer appropriately.”

Dr. Abou-Ismail considers safe advice to be simple public health messages that stay far out of specifics. Things like “don’t smoke,” or “eat a healthy diet,” and “get enough sleep,” fall into this safety zone. Even, “What is XYZ disease?” or “How do COVID vaccines work?” are topics he says he answers comfortably.

“But telling someone you need a specific treatment for a condition is inappropriate,” he explains. “This is a general way of practicing medicine – your advice should never venture into the potential of doing harm.”

This approach is exactly in line with legal advice, according to Jeff Caesar Chukwuma, founder and senior partner at Chukwuma Law Group, Miami. “It doesn’t mean that doctors should never give medical advice to friends or family, but if they do, they should make sure to take several precautions to protect both themselves and their family and friends,” he says.

When the request for medical advice from an acquaintance migrates into areas in which a physician is not a specialist, sharing recommendations gets even trickier – and more ethically questionable.  

Says Mr. Chukwuma, “Doctors should avoid giving advice in areas outside their area of expertise to lower the possibility of providing erroneous or harmful information,” he says.

How to stay safe when asked for advice

The American Medical Association has weighed in on the topic. In the Code of Medical Ethics Opinion 1.2.1, the AMA states that, “Treating oneself or a member of one’s own family poses several challenges for physicians, including concerns about professional objectivity, patient autonomy, and informed consent.”

What about friends or acquaintances, however?

Even so, some respondents voiced their concerns with the scenario. Responses like, “Due to ethics, I would prefer they go and get first, second, and third opinions,” and “Usually the medical advice is very basic first aid (often mental health first aid), and if it’s anything remotely more complicated, I direct them to the appropriate provider.”

The AMA places advising friends in the same basket as advising and treating family members or oneself. In an article appearing in the AMA Journal of Ethics, Horacio Hojman, MD, of Tufts University School of Medicine, Boston, weighed in: “First and foremost, patients deserve objectivity from their doctors. When a physician is emotionally involved with a patient, that physician’s objectivity can be called into question.”

Why is medical advice so thorny when dealing with friends or relatives?

In some cases, a physician might not ask a friend relevant personal questions about his or her medical history, for instance. Or the friend might not want to share details with the doctor. In either case, the lack of information exchange can lead to improper advice.

The issue of giving medical advice to friends, family, and acquaintances can also wade into legal territory. “Personally or professionally, trust is the decisive factor that puts us at ease with the people we surround ourselves with,” says Mr. Chukwuma. “Nowhere is this truer than in medicine, where we approach doctors with some of the most sensitive matters in our lives and entrust our care to them, especially when the physician in question is a close friend or family member.”

Mr. Chukwuma points out that, while there are few strict legal prohibitions against doctors providing care or advice to family and friends, the AMA’s code of ethics states that such action should be reserved for rare situations, such as emergency settings or isolated settings where there is no other qualified physician available, or for minor, not long-term problems.

This was part of the equation for Dr. Pribut when helping his mother navigate her treatment for breast cancer. “With close relatives, offering advice and help can be very hard,” he says.

“This is to protect both patients and doctors,” says Mr. Chukwuma. “Although seeking advice from a family member or friend who is a doctor may be more convenient for a patient, they run the risk of receiving inadequate care by not going in for a formal medical visit complete with tests, medical examination, and follow-up care.”

Mr. Chukwuma offers guidance on how to share medical advice ethically and legally with family, friends, and acquaintances. “First, as much as possible, speak to general medical facts and knowledge rather than comment directly on the patient’s particular situation,” he says. “In the absence of thorough examination and tests, the doctor’s knowledge of a patient’s condition is limited, therefore, you should take care not to provide seemingly definitive answers on that patient’s unique condition in situations where they can’t rely on data to back up their advice and recommendations.”

The AMA’s Journal of Ethics article shares these tips for staying on the right side of the ethical line when dealing with friends and family members:

• Politely decline.
• Offer other forms of assistance – this might help a friend find the right qualified physician – as Dr. Pribut tends to do. Maybe help in navigating the sometimes-confusing health care system.
• Don’t hesitate in an emergency – the old “is there a doctor on board,” scenario on a plane when someone is in distress is a perfectly acceptable, and recommended, time to step in, even if it is a friend or family member.

Dr. Pribut, a long-time veteran of the tricky medical waters involving friends and family, has this to offer: “Be cautious and always stay in the realm of what you know,” he says. “Always encourage people to seek an opinion from a qualified doctor. Help them find a reputable doctor if that’s useful.”

Mr. Chukwuma adds also that doctors should stand firm when pushed by a friend or family member, especially when offering advice, even if it’s in the form of general education. “The doctor should make it clear to the family member or friend that their advice in no way takes the place of actual treatment or examination by a medical professional and that, if need be, the patient should seek formal medical help from another doctor, ideally one not related to or friends with the patient,” he says.

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

Stephen Pribut, DPM, a sports medicine podiatrist based in Washington, has had many friends or family members ask him for medical advice. It’s a scenario every doctor will face at one point or another in their careers, and it’s never an easy one.

Dr. Pribut received a call from a friend about a sore shoulder from swimming, saying that his doctor had dismissed the potential for a rotator cuff injury. “Months later, images revealed it was a rotator cuff tear and he wanted my advice,” says Dr. Pribut.

Not being a shoulder specialist, Dr. Pribut limited his input. “I told him to consider a good physical therapist or a shoulder specialist and gave him some alternative strokes for swimming that hopefully wouldn’t aggravate the injury,” he explains.

But he admits some situations are challenging. “I had a relative asking about a third party with an ankle injury. I advised he hold off on using a balance board until things healed, and to make sure he went to see a specialist. Unfortunately, he went to his general practitioner who likely knows nothing about ankle anatomy,” says Dr. Pribut.

“I finally saw a photo, which revealed swelling higher up on the ankle and no evidence of a hematoma – much lower than we would see in an ankle ligament injury. I would like him to see a sports podiatrist or foot and ankle orthopedist, but now I have to stay calm when the advice isn’t followed,” he says.

Most doctors deal with the “curbside consult,” many times over, and most, according to a recent Medscape survey, will dole it out. When asked, “Do you give medical advice to your friends?” 96% of respondents answered yes.

Yazan Abou-Ismail, MD, assistant professor of medicine in the division of hematology at the University of Utah, Salt Lake City, has often faced questions from friends and family, particularly throughout the COVID-19 pandemic. “How you respond is something all physicians need to analyze carefully,” he says. “I get questions on a regular basis, but this greatly increased with COVID.”

“Sharing general information is okay, and it’s even a requirement that we educate on such topics,” says Dr. Abou-Ismail. “But if someone knows they have COVID, for instance, and wants advice on how to proceed, it’s important to send them to their primary care physician for an evaluation rather than give them instructions on care.”

Dr. Abou-Ismail says that most “curbside consulting” equates to lack of an ethical follow-up. “If you gave medical advice without having assessed them, you’re lacking the medical history, a physical exam, and you should not be giving advice,” he says. “This applies to follow-ups, too.”

Throughout the pandemic, Dr. Abou-Ismail’s requests for advice on COVID even extended to online inquiries, often from strangers. “This is not a place to do a formal assessment,” he reminds. “But there are certain types of advice you can offer appropriately.”

Dr. Abou-Ismail considers safe advice to be simple public health messages that stay far out of specifics. Things like “don’t smoke,” or “eat a healthy diet,” and “get enough sleep,” fall into this safety zone. Even, “What is XYZ disease?” or “How do COVID vaccines work?” are topics he says he answers comfortably.

“But telling someone you need a specific treatment for a condition is inappropriate,” he explains. “This is a general way of practicing medicine – your advice should never venture into the potential of doing harm.”

This approach is exactly in line with legal advice, according to Jeff Caesar Chukwuma, founder and senior partner at Chukwuma Law Group, Miami. “It doesn’t mean that doctors should never give medical advice to friends or family, but if they do, they should make sure to take several precautions to protect both themselves and their family and friends,” he says.

When the request for medical advice from an acquaintance migrates into areas in which a physician is not a specialist, sharing recommendations gets even trickier – and more ethically questionable.  

Says Mr. Chukwuma, “Doctors should avoid giving advice in areas outside their area of expertise to lower the possibility of providing erroneous or harmful information,” he says.

How to stay safe when asked for advice

The American Medical Association has weighed in on the topic. In the Code of Medical Ethics Opinion 1.2.1, the AMA states that, “Treating oneself or a member of one’s own family poses several challenges for physicians, including concerns about professional objectivity, patient autonomy, and informed consent.”

What about friends or acquaintances, however?

Even so, some respondents voiced their concerns with the scenario. Responses like, “Due to ethics, I would prefer they go and get first, second, and third opinions,” and “Usually the medical advice is very basic first aid (often mental health first aid), and if it’s anything remotely more complicated, I direct them to the appropriate provider.”

The AMA places advising friends in the same basket as advising and treating family members or oneself. In an article appearing in the AMA Journal of Ethics, Horacio Hojman, MD, of Tufts University School of Medicine, Boston, weighed in: “First and foremost, patients deserve objectivity from their doctors. When a physician is emotionally involved with a patient, that physician’s objectivity can be called into question.”

Why is medical advice so thorny when dealing with friends or relatives?

In some cases, a physician might not ask a friend relevant personal questions about his or her medical history, for instance. Or the friend might not want to share details with the doctor. In either case, the lack of information exchange can lead to improper advice.

The issue of giving medical advice to friends, family, and acquaintances can also wade into legal territory. “Personally or professionally, trust is the decisive factor that puts us at ease with the people we surround ourselves with,” says Mr. Chukwuma. “Nowhere is this truer than in medicine, where we approach doctors with some of the most sensitive matters in our lives and entrust our care to them, especially when the physician in question is a close friend or family member.”

Mr. Chukwuma points out that, while there are few strict legal prohibitions against doctors providing care or advice to family and friends, the AMA’s code of ethics states that such action should be reserved for rare situations, such as emergency settings or isolated settings where there is no other qualified physician available, or for minor, not long-term problems.

This was part of the equation for Dr. Pribut when helping his mother navigate her treatment for breast cancer. “With close relatives, offering advice and help can be very hard,” he says.

“This is to protect both patients and doctors,” says Mr. Chukwuma. “Although seeking advice from a family member or friend who is a doctor may be more convenient for a patient, they run the risk of receiving inadequate care by not going in for a formal medical visit complete with tests, medical examination, and follow-up care.”

Mr. Chukwuma offers guidance on how to share medical advice ethically and legally with family, friends, and acquaintances. “First, as much as possible, speak to general medical facts and knowledge rather than comment directly on the patient’s particular situation,” he says. “In the absence of thorough examination and tests, the doctor’s knowledge of a patient’s condition is limited, therefore, you should take care not to provide seemingly definitive answers on that patient’s unique condition in situations where they can’t rely on data to back up their advice and recommendations.”

The AMA’s Journal of Ethics article shares these tips for staying on the right side of the ethical line when dealing with friends and family members:

• Politely decline.
• Offer other forms of assistance – this might help a friend find the right qualified physician – as Dr. Pribut tends to do. Maybe help in navigating the sometimes-confusing health care system.
• Don’t hesitate in an emergency – the old “is there a doctor on board,” scenario on a plane when someone is in distress is a perfectly acceptable, and recommended, time to step in, even if it is a friend or family member.

Dr. Pribut, a long-time veteran of the tricky medical waters involving friends and family, has this to offer: “Be cautious and always stay in the realm of what you know,” he says. “Always encourage people to seek an opinion from a qualified doctor. Help them find a reputable doctor if that’s useful.”

Mr. Chukwuma adds also that doctors should stand firm when pushed by a friend or family member, especially when offering advice, even if it’s in the form of general education. “The doctor should make it clear to the family member or friend that their advice in no way takes the place of actual treatment or examination by a medical professional and that, if need be, the patient should seek formal medical help from another doctor, ideally one not related to or friends with the patient,” he says.

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

Medicare will cover the full cost of colonoscopy after a positive noninvasive fecal test beginning in 2023, largely in response to a year-long advocacy campaign.

The benefit expansion is a “huge win” for patients, according to the American Gastroenterological Association, because it represents the end of out-of-pocket costs for colorectal cancer (CRC) screening.

“The continuum is complete!” said John Inadomi, MD, AGAF, past president of the AGA and a champion of the initiative within the organization.

Colonoscopy after a positive fecal test was previously considered a diagnostic procedure and therefore not considered part of the screening process by the Affordable Care Act, allowing payers to charge patients. That is, until the AGA and partners, including the American Cancer Society Cancer Action Network and Fight Colorectal Cancer, pushed back. First, the organizations successfully campaigned to ensure that private payers would cover the follow-up procedure. Now, after multiple meetings with the United States Department of Health & Human Services and Centers for Medicare & Medicaid Services, their collaborative efforts will end screening costs for patients with Medicare, pending finalization of the rule this fall. If finalized, it will take effect Jan. 2, 2023.

The policy change will “directly advance health equity” the AGA said, particularly among “rural communities and communities of color,” which are disproportionally affected by CRC.

“Cost-sharing is a well-recognized barrier to screening and has resulted in disparities,” said David Lieberman, MD, AGAF, who met with the CMS multiple times on behalf of the AGA. “Patients can now engage in CRC screening programs and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test.”

AGA president John Carethers, MD, AGAF, who also met with the CMS, noted that reducing barriers to CRC screening will ultimately reduce CRC mortality.

“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives,” he said.

Dr. Inadomi, Dr. Carethers, and Dr. Lieberman serve on the scientific advisory board of Geneoscopy; Dr. Lieberman is also on the scientific advisory board for ColoWrap.

Medicare will cover the full cost of colonoscopy after a positive noninvasive fecal test beginning in 2023, largely in response to a year-long advocacy campaign.

The benefit expansion is a “huge win” for patients, according to the American Gastroenterological Association, because it represents the end of out-of-pocket costs for colorectal cancer (CRC) screening.

“The continuum is complete!” said John Inadomi, MD, AGAF, past president of the AGA and a champion of the initiative within the organization.

Colonoscopy after a positive fecal test was previously considered a diagnostic procedure and therefore not considered part of the screening process by the Affordable Care Act, allowing payers to charge patients. That is, until the AGA and partners, including the American Cancer Society Cancer Action Network and Fight Colorectal Cancer, pushed back. First, the organizations successfully campaigned to ensure that private payers would cover the follow-up procedure. Now, after multiple meetings with the United States Department of Health & Human Services and Centers for Medicare & Medicaid Services, their collaborative efforts will end screening costs for patients with Medicare, pending finalization of the rule this fall. If finalized, it will take effect Jan. 2, 2023.

The policy change will “directly advance health equity” the AGA said, particularly among “rural communities and communities of color,” which are disproportionally affected by CRC.

“Cost-sharing is a well-recognized barrier to screening and has resulted in disparities,” said David Lieberman, MD, AGAF, who met with the CMS multiple times on behalf of the AGA. “Patients can now engage in CRC screening programs and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test.”

AGA president John Carethers, MD, AGAF, who also met with the CMS, noted that reducing barriers to CRC screening will ultimately reduce CRC mortality.

“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives,” he said.

Dr. Inadomi, Dr. Carethers, and Dr. Lieberman serve on the scientific advisory board of Geneoscopy; Dr. Lieberman is also on the scientific advisory board for ColoWrap.

Medicare will cover the full cost of colonoscopy after a positive noninvasive fecal test beginning in 2023, largely in response to a year-long advocacy campaign.

The benefit expansion is a “huge win” for patients, according to the American Gastroenterological Association, because it represents the end of out-of-pocket costs for colorectal cancer (CRC) screening.

“The continuum is complete!” said John Inadomi, MD, AGAF, past president of the AGA and a champion of the initiative within the organization.

Colonoscopy after a positive fecal test was previously considered a diagnostic procedure and therefore not considered part of the screening process by the Affordable Care Act, allowing payers to charge patients. That is, until the AGA and partners, including the American Cancer Society Cancer Action Network and Fight Colorectal Cancer, pushed back. First, the organizations successfully campaigned to ensure that private payers would cover the follow-up procedure. Now, after multiple meetings with the United States Department of Health & Human Services and Centers for Medicare & Medicaid Services, their collaborative efforts will end screening costs for patients with Medicare, pending finalization of the rule this fall. If finalized, it will take effect Jan. 2, 2023.

The policy change will “directly advance health equity” the AGA said, particularly among “rural communities and communities of color,” which are disproportionally affected by CRC.

“Cost-sharing is a well-recognized barrier to screening and has resulted in disparities,” said David Lieberman, MD, AGAF, who met with the CMS multiple times on behalf of the AGA. “Patients can now engage in CRC screening programs and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test.”

AGA president John Carethers, MD, AGAF, who also met with the CMS, noted that reducing barriers to CRC screening will ultimately reduce CRC mortality.

“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives,” he said.

Dr. Inadomi, Dr. Carethers, and Dr. Lieberman serve on the scientific advisory board of Geneoscopy; Dr. Lieberman is also on the scientific advisory board for ColoWrap.

A new study among patients with inflammatory bowel disease (IBD) suggests that viral antigen persistence in the gut may contribute to post-acute COVID-19 syndrome.

Postacute COVID-19 syndrome is now understood to be a multiorgan condition with symptoms that may include fatigue, cognitive dysfunction, and pain. Poor baseline health and severe acute infection are risk factors for the condition, but nonhospitalized illness can also lead to persistent symptoms.

Researchers found that nearly two-thirds of IBD patients had persistence of the antigen in infected tissues up to 8 months after a mild (nonhospitalized) acute COVID-19 infection. The study is the first to tie gut antigen persistence to post-acute COVID symptoms, and the results imply that the antigen may lead to immune perturbation and ongoing symptoms.

The study was published online in Gastroenterology.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) uses the membrane-bound angiotensin-converting enzyme 2 to gain entry into cells, which is expressed in the brush border enterocytes, as well as elsewhere in the body.

Previous research using intestinal epithelial organoids confirmed that SARS-CoV-2 is capable of infecting the human epithelium and that the virus can be detected in anal swabs long after it is cleared from nasal passages.

One potential explanation is viral immune perturbation or inflammatory tissue injury. Supporting evidence includes neural accumulation of memory T cells in patients with neuropsychiatric symptoms such as malaise and depression, and similar changes are seen with age-related immune senescence and tissue injury. Hyperactivated B and T cells, as well as other innate immune cells, have also been linked to postacute COVID-19, as has heightened expression of proinflammatory cytokines.

To explore the potential role of persistent viral antigens, the researchers gathered biopsies during upper- and lower-gastrointestinal endoscopy in 46 patients with IBD whose prior COVID-19 infection (mean, 7.3 months previous) had been confirmed by polymerase chain reaction and who were seen at the IBD outpatient unit of the investigators’ institution. In all, 43.5% of patients were female, and the average age was 44.67 years. Overall, 67.4% had been diagnosed with Crohn’s disease, 28.3% with ulcerative colitis, and 4.3% had unclassified IBD; 23.9% had a history of exposure to anti–tumor necrosis factor therapy. Among patients in the study, 32 of the patients tested positive for mucosal SARS-CoV-2 RNA, and there was no association between the presence of viral RNA and IBD type.

The researchers found that 52%-70% of patients had antigen persistence in any gut segment, as measured by nucleocapsid immunofluorescence or expression of one of four viral transcripts. They detected persistence of the nucleocapsid in epithelial cells and CD8+ T cells. Viral antigens persisted in patients with and without exposure to immunosuppressive therapy, and there was no association with antigen persistence and severity of acute COVID-19 infection or the presence of inflammation at the time of the endoscopy.

The researchers believed that the persistent viral antigen reflects incomplete clearance from the original infection rather than a latent or persistent infection because they could not replicate the virus in biopsy samples. Most biopsies within a patient produced some, but not all, of the viral transcripts tested. The authors suggest that immunosuppressive therapy may lead to incomplete viral clearance. Some patients lacked humoral nucleocapsid IgG antibodies, especially among those with gut antigen persistence.

In fact, only patients with gut viral RNA persistence had symptoms of postacute COVID. “This observation strongly argues for a role of viral antigen persistence in postacute COVID-19 and it appears plausible that SARS-CoV-2 antigen persistence, possibly in infected tissues beyond the gut, could impact host immune responses underlying the postacute COVID-19 syndrome,” the researchers wrote.

There is precedent for such a phenomenon in influenza. Mouse models have shown that ineffective clearance can influence adaptive immune responses and memory T-cell formation in lymph nodes of the lung. Another report found that COVID-19 pneumonia survivors have persistent changes to pulmonary CD8+ T cells.

The study is limited by its small sample size and a lack of a replication cohort. The study was also conducted in IBD patients because the researchers believed they were at higher risk of COVID-19 infection, although the researchers note that viral antigen persistence has been observed 2 months after recovery from COVID-19 in patients without IBD or exposure to immunosuppressants.

The researchers call for studies in patients without IBD to determine whether viral antigen persistence is a key mechanism in postacute COVID-19.

The researchers have no relevant financial disclosures.

A new study among patients with inflammatory bowel disease (IBD) suggests that viral antigen persistence in the gut may contribute to post-acute COVID-19 syndrome.

Postacute COVID-19 syndrome is now understood to be a multiorgan condition with symptoms that may include fatigue, cognitive dysfunction, and pain. Poor baseline health and severe acute infection are risk factors for the condition, but nonhospitalized illness can also lead to persistent symptoms.

Researchers found that nearly two-thirds of IBD patients had persistence of the antigen in infected tissues up to 8 months after a mild (nonhospitalized) acute COVID-19 infection. The study is the first to tie gut antigen persistence to post-acute COVID symptoms, and the results imply that the antigen may lead to immune perturbation and ongoing symptoms.

The study was published online in Gastroenterology.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) uses the membrane-bound angiotensin-converting enzyme 2 to gain entry into cells, which is expressed in the brush border enterocytes, as well as elsewhere in the body.

Previous research using intestinal epithelial organoids confirmed that SARS-CoV-2 is capable of infecting the human epithelium and that the virus can be detected in anal swabs long after it is cleared from nasal passages.

One potential explanation is viral immune perturbation or inflammatory tissue injury. Supporting evidence includes neural accumulation of memory T cells in patients with neuropsychiatric symptoms such as malaise and depression, and similar changes are seen with age-related immune senescence and tissue injury. Hyperactivated B and T cells, as well as other innate immune cells, have also been linked to postacute COVID-19, as has heightened expression of proinflammatory cytokines.

To explore the potential role of persistent viral antigens, the researchers gathered biopsies during upper- and lower-gastrointestinal endoscopy in 46 patients with IBD whose prior COVID-19 infection (mean, 7.3 months previous) had been confirmed by polymerase chain reaction and who were seen at the IBD outpatient unit of the investigators’ institution. In all, 43.5% of patients were female, and the average age was 44.67 years. Overall, 67.4% had been diagnosed with Crohn’s disease, 28.3% with ulcerative colitis, and 4.3% had unclassified IBD; 23.9% had a history of exposure to anti–tumor necrosis factor therapy. Among patients in the study, 32 of the patients tested positive for mucosal SARS-CoV-2 RNA, and there was no association between the presence of viral RNA and IBD type.

The researchers found that 52%-70% of patients had antigen persistence in any gut segment, as measured by nucleocapsid immunofluorescence or expression of one of four viral transcripts. They detected persistence of the nucleocapsid in epithelial cells and CD8+ T cells. Viral antigens persisted in patients with and without exposure to immunosuppressive therapy, and there was no association with antigen persistence and severity of acute COVID-19 infection or the presence of inflammation at the time of the endoscopy.

The researchers believed that the persistent viral antigen reflects incomplete clearance from the original infection rather than a latent or persistent infection because they could not replicate the virus in biopsy samples. Most biopsies within a patient produced some, but not all, of the viral transcripts tested. The authors suggest that immunosuppressive therapy may lead to incomplete viral clearance. Some patients lacked humoral nucleocapsid IgG antibodies, especially among those with gut antigen persistence.

In fact, only patients with gut viral RNA persistence had symptoms of postacute COVID. “This observation strongly argues for a role of viral antigen persistence in postacute COVID-19 and it appears plausible that SARS-CoV-2 antigen persistence, possibly in infected tissues beyond the gut, could impact host immune responses underlying the postacute COVID-19 syndrome,” the researchers wrote.

There is precedent for such a phenomenon in influenza. Mouse models have shown that ineffective clearance can influence adaptive immune responses and memory T-cell formation in lymph nodes of the lung. Another report found that COVID-19 pneumonia survivors have persistent changes to pulmonary CD8+ T cells.

The study is limited by its small sample size and a lack of a replication cohort. The study was also conducted in IBD patients because the researchers believed they were at higher risk of COVID-19 infection, although the researchers note that viral antigen persistence has been observed 2 months after recovery from COVID-19 in patients without IBD or exposure to immunosuppressants.

The researchers call for studies in patients without IBD to determine whether viral antigen persistence is a key mechanism in postacute COVID-19.

The researchers have no relevant financial disclosures.

A new study among patients with inflammatory bowel disease (IBD) suggests that viral antigen persistence in the gut may contribute to post-acute COVID-19 syndrome.

Postacute COVID-19 syndrome is now understood to be a multiorgan condition with symptoms that may include fatigue, cognitive dysfunction, and pain. Poor baseline health and severe acute infection are risk factors for the condition, but nonhospitalized illness can also lead to persistent symptoms.

Researchers found that nearly two-thirds of IBD patients had persistence of the antigen in infected tissues up to 8 months after a mild (nonhospitalized) acute COVID-19 infection. The study is the first to tie gut antigen persistence to post-acute COVID symptoms, and the results imply that the antigen may lead to immune perturbation and ongoing symptoms.

The study was published online in Gastroenterology.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) uses the membrane-bound angiotensin-converting enzyme 2 to gain entry into cells, which is expressed in the brush border enterocytes, as well as elsewhere in the body.

Previous research using intestinal epithelial organoids confirmed that SARS-CoV-2 is capable of infecting the human epithelium and that the virus can be detected in anal swabs long after it is cleared from nasal passages.

One potential explanation is viral immune perturbation or inflammatory tissue injury. Supporting evidence includes neural accumulation of memory T cells in patients with neuropsychiatric symptoms such as malaise and depression, and similar changes are seen with age-related immune senescence and tissue injury. Hyperactivated B and T cells, as well as other innate immune cells, have also been linked to postacute COVID-19, as has heightened expression of proinflammatory cytokines.

To explore the potential role of persistent viral antigens, the researchers gathered biopsies during upper- and lower-gastrointestinal endoscopy in 46 patients with IBD whose prior COVID-19 infection (mean, 7.3 months previous) had been confirmed by polymerase chain reaction and who were seen at the IBD outpatient unit of the investigators’ institution. In all, 43.5% of patients were female, and the average age was 44.67 years. Overall, 67.4% had been diagnosed with Crohn’s disease, 28.3% with ulcerative colitis, and 4.3% had unclassified IBD; 23.9% had a history of exposure to anti–tumor necrosis factor therapy. Among patients in the study, 32 of the patients tested positive for mucosal SARS-CoV-2 RNA, and there was no association between the presence of viral RNA and IBD type.

The researchers found that 52%-70% of patients had antigen persistence in any gut segment, as measured by nucleocapsid immunofluorescence or expression of one of four viral transcripts. They detected persistence of the nucleocapsid in epithelial cells and CD8+ T cells. Viral antigens persisted in patients with and without exposure to immunosuppressive therapy, and there was no association with antigen persistence and severity of acute COVID-19 infection or the presence of inflammation at the time of the endoscopy.

The researchers believed that the persistent viral antigen reflects incomplete clearance from the original infection rather than a latent or persistent infection because they could not replicate the virus in biopsy samples. Most biopsies within a patient produced some, but not all, of the viral transcripts tested. The authors suggest that immunosuppressive therapy may lead to incomplete viral clearance. Some patients lacked humoral nucleocapsid IgG antibodies, especially among those with gut antigen persistence.

In fact, only patients with gut viral RNA persistence had symptoms of postacute COVID. “This observation strongly argues for a role of viral antigen persistence in postacute COVID-19 and it appears plausible that SARS-CoV-2 antigen persistence, possibly in infected tissues beyond the gut, could impact host immune responses underlying the postacute COVID-19 syndrome,” the researchers wrote.

There is precedent for such a phenomenon in influenza. Mouse models have shown that ineffective clearance can influence adaptive immune responses and memory T-cell formation in lymph nodes of the lung. Another report found that COVID-19 pneumonia survivors have persistent changes to pulmonary CD8+ T cells.

The study is limited by its small sample size and a lack of a replication cohort. The study was also conducted in IBD patients because the researchers believed they were at higher risk of COVID-19 infection, although the researchers note that viral antigen persistence has been observed 2 months after recovery from COVID-19 in patients without IBD or exposure to immunosuppressants.

The researchers call for studies in patients without IBD to determine whether viral antigen persistence is a key mechanism in postacute COVID-19.

The researchers have no relevant financial disclosures.

Cognitive impairment is a good predictor of physical disability progression in patients with multiple sclerosis (MS), new research suggests. In an analysis of more than 1,600 patients with secondary-progressive MS (SPMS), the likelihood of needing a wheelchair was almost doubled in those who had the worst scores on cognitive testing measures, compared with their counterparts who had the best scores.

“These findings should change our world view of MS,” study investigator Gavin Giovannoni, PhD, professor of neurology, Blizard Institute, Faculty of Medicine and Dentistry, Queen Mary University of London, told attendees at the Congress of the European Academy of Neurology.

Expand data

Cognitive impairment occurs very early in the course of MS and is part of the disease, although to a greater or lesser degree depending on the patient, Dr. Giovannoni noted. Such impairment has a significant impact on quality of life for patients dealing with this disease, he added.

EXPAND was a phase 3 study of siponimod. Results showed the now-approved oral selective sphingosine 1–phosphate receptor modulator significantly reduced the risk for disability progression in patients with SPMS.

Using the EXPAND clinical trial database, the current researchers assessed 1,628 participants for an association between cognitive processing speed, as measured with the Symbol Digit Modality Test (SDMT), and physical disability progression, as measured with the Expanded Disability Status Scale (EDSS). A score of 7 or more on the EDSS indicates wheelchair dependence.

Dr. Giovannoni noted that cognitive processing speed is considered an indirect measure of thalamic network efficiency and functional brain reserve.

Investigators looked at both the core study, in which all patients continued on treatment or placebo for up to 37 months, and the core plus extension part, in which patients received treatment for up to 5 years.

They separated SDMT scores into quartiles: from worst (n = 435) to two intermediate quartiles (n = 808) to the best quartile (n = 385).
 

Wheelchair dependence

In addition, the researchers examined the predictive value by baseline SDMT, adjusting for treatment, age, gender, baseline EDSS score, baseline SCMT quartile, and treatment-by-baseline SCMT quartile interaction. On-study SDMT change (month 0-24) was also assessed after adjusting for treatment, age, gender, baseline EDS, baseline SCMT, and on-study change in SCMT quartile.

In the core study, those in the worst SDMT quartile at baseline were numerically more likely to reach deterioration to EDSS 7 or greater (wheelchair dependent), compared with patients in the best SDMT quartile (hazard ratio, 1.31; 95% confidence interval, .72-2.38; P = .371).

The short-term predictive value of baseline SDMT for reaching sustained EDSS of at least 7 was more obvious in the placebo arm than in the treatment arm.

Dr. Giovannoni said this is likely due to the treatment effect of siponimod preventing relatively more events in the worse quartile, and so reducing the risk for wheelchair dependency.

In the core plus extension part, there was an almost twofold increased risk for wheelchair dependence in the worse versus best SDMT groups (HR, 1.81; 95% CI, 1.17-2.78; P = .007).

Both baseline SDMT (HR, 1.81; P = .007) and on-study change in SDMT (HR, 1.73; P = .046) predicted wheelchair dependence in the long-term.
 

‘More important than a walking stick’

Measuring cognitive change over time “may be a more important predictor than a walking stick in terms of quality of life and outcomes, and it affects clinical decisionmaking,” said Dr. Giovannoni.

The findings are not novel, as post hoc analyses of other studies showed similar results. However, this new analysis adds more evidence to the importance of cognition in MS, Dr. Giovannoni noted.

“I have patients with EDSS of 0 or 1 who are profoundly disabled because of cognition. You shouldn’t just assume someone is not disabled because they don’t have physical disability,” he said.

However, Dr. Giovannoni noted that the study found an association and does not necessarily indicate a cause.
 

‘Valuable’ insights

Antonia Lefter, MD, of NeuroHope, Monza Oncologic Hospital, Bucharest, Romania, cochaired the session highlighting the research. Commenting on the study, she called this analysis from the “renowned” EXPAND study “valuable.”

In addition, it “underscores” the importance of assessing cognitive processing speed, as it may predict long-term disability progression in patients with SPMS, Dr. Lefter said.

The study was funded by Novartis Pharma AG, Basel, Switzerland. Dr. Giovannoni, a steering committee member of the EXPAND trial, reported receiving consulting fees from AbbVie, Actelion, Atara Bio, Biogen, Celgene, Sanofi-Genzyme, Genentech, GlaxoSmithKline, Merck-Serono, Novartis, Roche, and Reva. He has also received compensation for research from Biogen, Roche, Merck-Serono, Novartis, Sanofi-Genzyme, and Takeda. Dr. Lefter has reported no relevant financial relationships.

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

Cognitive impairment is a good predictor of physical disability progression in patients with multiple sclerosis (MS), new research suggests. In an analysis of more than 1,600 patients with secondary-progressive MS (SPMS), the likelihood of needing a wheelchair was almost doubled in those who had the worst scores on cognitive testing measures, compared with their counterparts who had the best scores.

“These findings should change our world view of MS,” study investigator Gavin Giovannoni, PhD, professor of neurology, Blizard Institute, Faculty of Medicine and Dentistry, Queen Mary University of London, told attendees at the Congress of the European Academy of Neurology.

Expand data

Cognitive impairment occurs very early in the course of MS and is part of the disease, although to a greater or lesser degree depending on the patient, Dr. Giovannoni noted. Such impairment has a significant impact on quality of life for patients dealing with this disease, he added.

EXPAND was a phase 3 study of siponimod. Results showed the now-approved oral selective sphingosine 1–phosphate receptor modulator significantly reduced the risk for disability progression in patients with SPMS.

Using the EXPAND clinical trial database, the current researchers assessed 1,628 participants for an association between cognitive processing speed, as measured with the Symbol Digit Modality Test (SDMT), and physical disability progression, as measured with the Expanded Disability Status Scale (EDSS). A score of 7 or more on the EDSS indicates wheelchair dependence.

Dr. Giovannoni noted that cognitive processing speed is considered an indirect measure of thalamic network efficiency and functional brain reserve.

Investigators looked at both the core study, in which all patients continued on treatment or placebo for up to 37 months, and the core plus extension part, in which patients received treatment for up to 5 years.

They separated SDMT scores into quartiles: from worst (n = 435) to two intermediate quartiles (n = 808) to the best quartile (n = 385).
 

Wheelchair dependence

In addition, the researchers examined the predictive value by baseline SDMT, adjusting for treatment, age, gender, baseline EDSS score, baseline SCMT quartile, and treatment-by-baseline SCMT quartile interaction. On-study SDMT change (month 0-24) was also assessed after adjusting for treatment, age, gender, baseline EDS, baseline SCMT, and on-study change in SCMT quartile.

In the core study, those in the worst SDMT quartile at baseline were numerically more likely to reach deterioration to EDSS 7 or greater (wheelchair dependent), compared with patients in the best SDMT quartile (hazard ratio, 1.31; 95% confidence interval, .72-2.38; P = .371).

The short-term predictive value of baseline SDMT for reaching sustained EDSS of at least 7 was more obvious in the placebo arm than in the treatment arm.

Dr. Giovannoni said this is likely due to the treatment effect of siponimod preventing relatively more events in the worse quartile, and so reducing the risk for wheelchair dependency.

In the core plus extension part, there was an almost twofold increased risk for wheelchair dependence in the worse versus best SDMT groups (HR, 1.81; 95% CI, 1.17-2.78; P = .007).

Both baseline SDMT (HR, 1.81; P = .007) and on-study change in SDMT (HR, 1.73; P = .046) predicted wheelchair dependence in the long-term.
 

‘More important than a walking stick’

Measuring cognitive change over time “may be a more important predictor than a walking stick in terms of quality of life and outcomes, and it affects clinical decisionmaking,” said Dr. Giovannoni.

The findings are not novel, as post hoc analyses of other studies showed similar results. However, this new analysis adds more evidence to the importance of cognition in MS, Dr. Giovannoni noted.

“I have patients with EDSS of 0 or 1 who are profoundly disabled because of cognition. You shouldn’t just assume someone is not disabled because they don’t have physical disability,” he said.

However, Dr. Giovannoni noted that the study found an association and does not necessarily indicate a cause.
 

‘Valuable’ insights

Antonia Lefter, MD, of NeuroHope, Monza Oncologic Hospital, Bucharest, Romania, cochaired the session highlighting the research. Commenting on the study, she called this analysis from the “renowned” EXPAND study “valuable.”

In addition, it “underscores” the importance of assessing cognitive processing speed, as it may predict long-term disability progression in patients with SPMS, Dr. Lefter said.

The study was funded by Novartis Pharma AG, Basel, Switzerland. Dr. Giovannoni, a steering committee member of the EXPAND trial, reported receiving consulting fees from AbbVie, Actelion, Atara Bio, Biogen, Celgene, Sanofi-Genzyme, Genentech, GlaxoSmithKline, Merck-Serono, Novartis, Roche, and Reva. He has also received compensation for research from Biogen, Roche, Merck-Serono, Novartis, Sanofi-Genzyme, and Takeda. Dr. Lefter has reported no relevant financial relationships.

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

Cognitive impairment is a good predictor of physical disability progression in patients with multiple sclerosis (MS), new research suggests. In an analysis of more than 1,600 patients with secondary-progressive MS (SPMS), the likelihood of needing a wheelchair was almost doubled in those who had the worst scores on cognitive testing measures, compared with their counterparts who had the best scores.

“These findings should change our world view of MS,” study investigator Gavin Giovannoni, PhD, professor of neurology, Blizard Institute, Faculty of Medicine and Dentistry, Queen Mary University of London, told attendees at the Congress of the European Academy of Neurology.

Expand data

Cognitive impairment occurs very early in the course of MS and is part of the disease, although to a greater or lesser degree depending on the patient, Dr. Giovannoni noted. Such impairment has a significant impact on quality of life for patients dealing with this disease, he added.

EXPAND was a phase 3 study of siponimod. Results showed the now-approved oral selective sphingosine 1–phosphate receptor modulator significantly reduced the risk for disability progression in patients with SPMS.

Using the EXPAND clinical trial database, the current researchers assessed 1,628 participants for an association between cognitive processing speed, as measured with the Symbol Digit Modality Test (SDMT), and physical disability progression, as measured with the Expanded Disability Status Scale (EDSS). A score of 7 or more on the EDSS indicates wheelchair dependence.

Dr. Giovannoni noted that cognitive processing speed is considered an indirect measure of thalamic network efficiency and functional brain reserve.

Investigators looked at both the core study, in which all patients continued on treatment or placebo for up to 37 months, and the core plus extension part, in which patients received treatment for up to 5 years.

They separated SDMT scores into quartiles: from worst (n = 435) to two intermediate quartiles (n = 808) to the best quartile (n = 385).
 

Wheelchair dependence

In addition, the researchers examined the predictive value by baseline SDMT, adjusting for treatment, age, gender, baseline EDSS score, baseline SCMT quartile, and treatment-by-baseline SCMT quartile interaction. On-study SDMT change (month 0-24) was also assessed after adjusting for treatment, age, gender, baseline EDS, baseline SCMT, and on-study change in SCMT quartile.

In the core study, those in the worst SDMT quartile at baseline were numerically more likely to reach deterioration to EDSS 7 or greater (wheelchair dependent), compared with patients in the best SDMT quartile (hazard ratio, 1.31; 95% confidence interval, .72-2.38; P = .371).

The short-term predictive value of baseline SDMT for reaching sustained EDSS of at least 7 was more obvious in the placebo arm than in the treatment arm.

Dr. Giovannoni said this is likely due to the treatment effect of siponimod preventing relatively more events in the worse quartile, and so reducing the risk for wheelchair dependency.

In the core plus extension part, there was an almost twofold increased risk for wheelchair dependence in the worse versus best SDMT groups (HR, 1.81; 95% CI, 1.17-2.78; P = .007).

Both baseline SDMT (HR, 1.81; P = .007) and on-study change in SDMT (HR, 1.73; P = .046) predicted wheelchair dependence in the long-term.
 

‘More important than a walking stick’

Measuring cognitive change over time “may be a more important predictor than a walking stick in terms of quality of life and outcomes, and it affects clinical decisionmaking,” said Dr. Giovannoni.

The findings are not novel, as post hoc analyses of other studies showed similar results. However, this new analysis adds more evidence to the importance of cognition in MS, Dr. Giovannoni noted.

“I have patients with EDSS of 0 or 1 who are profoundly disabled because of cognition. You shouldn’t just assume someone is not disabled because they don’t have physical disability,” he said.

However, Dr. Giovannoni noted that the study found an association and does not necessarily indicate a cause.
 

‘Valuable’ insights

Antonia Lefter, MD, of NeuroHope, Monza Oncologic Hospital, Bucharest, Romania, cochaired the session highlighting the research. Commenting on the study, she called this analysis from the “renowned” EXPAND study “valuable.”

In addition, it “underscores” the importance of assessing cognitive processing speed, as it may predict long-term disability progression in patients with SPMS, Dr. Lefter said.

The study was funded by Novartis Pharma AG, Basel, Switzerland. Dr. Giovannoni, a steering committee member of the EXPAND trial, reported receiving consulting fees from AbbVie, Actelion, Atara Bio, Biogen, Celgene, Sanofi-Genzyme, Genentech, GlaxoSmithKline, Merck-Serono, Novartis, Roche, and Reva. He has also received compensation for research from Biogen, Roche, Merck-Serono, Novartis, Sanofi-Genzyme, and Takeda. Dr. Lefter has reported no relevant financial relationships.

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