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Neonatal hypoglycemia doesn’t affect childhood academics

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Children at risk of neonatal hypoglycemia who were screened and treated if needed showed no difference in educational achievement from controls at age 9-10 years, based on data from 480 children.

Previous studies have shown an increased risk of poor executive and visual-motor function in children with neonatal hypoglycemia, but the effect on later childhood academic performance remains unclear, wrote Rajesh Shah, PhD, of the University of Auckland, New Zealand, and colleagues.

In a prospective cohort study published in JAMA, the researchers enrolled moderate to late preterm and term infants born at increased risk for hypoglycemia; those with episodes of hypoglycemia were treated to maintain a blood glucose concentration of at least 47 mg/dL.

The study population was enrolled between 2006 and 2010 at a regional perinatal center in New Zealand, and their educational achievement was assessed 9-10 years later. The primary outcome of low educational achievement was defined as performing below the normal curriculum level in standardized tests of reading comprehension or math. The researchers also identified 47 secondary outcomes related to executive function, visual-motor function, psychosocial adaptation, and general health.

Rates of low educational achievement were not significantly different for children with and without neonatal hypoglycemia (47% vs. 48%, adjusted risk ratio 0.95).

No significant differences appeared between the two groups for any secondary outcomes, including reading comprehension, math, behavior manifestations of executive function, fine motor function, autism traits, and overall well-being, the researchers noted.

However, children with neonatal hypoglycemia were significantly less likely to be rated as below or well below reading curriculum level by teachers compared to those without neonatal hypoglycemia (24% vs. 31%).

The researchers cited a previous study of the same patient cohort at age 4.5 years, which suggested an association between adverse neurodevelopmental outcomes and infant hypoglycemia. However, the reason this association did not persist at age 9-10 years remains unclear, the researchers wrote in their discussion. “Early disturbances in brain development may have diminishing effects over time due to neuroplasticity, that is, reorganization of neural networks, or delayed maturation with mid-childhood catch-up in neurocognitive function,” they said.

The study findings were limited by several factors including the lack of data on several measures of cognition, notably processing speed, and a lack of adjustment for intelligence quotient at age 4.5 years, the lack of data on any treatment for developmental impairment, and the inclusion of a population with well-managed hypoglycemia, the researchers said.

However, the results were strengthened by having a sample size large enough to detect associations, the prospective design, and the accurate measure of neonatal glycemic exposure, they said. Although the results suggest that at-risk children reach similar endpoints by the end of primary school, “efforts to prevent and optimize adverse pregnancy conditions remain important, and developmental surveillance after birth should be considered for at-risk infants,” they concluded.

In a related study published in JAMA, Taygen Edwards and colleagues found that prophylactic oral dextrose gel had no significant effect on neurosensory function.

The study, a prospective follow-up of a multicenter randomized trial, included 1,197 later preterm or term infants deemed at risk for neonatal hypoglycemia. The infants (49% of whom were female) were randomized to prophylactic 40% dextrose gel or a placebo, massaged into the buccal mucosa at 1 hour after birth.

The primary outcome was neurosensory impairment at 2 years of age, which was assessed by neurologic examination, parent-reported medical questionnaires, Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), performance-based executive function, Behavior Rating Inventory of Executive Function–Preschool Version, motion coherence thresholds, growth, and body composition.

At 2 years of age, the prevalence of neurosensory impairment was 21% and 19%, respectively, in infants randomized to prophylactic oral dextrose gel and placebo, a nonsignificant difference. No differences between the two groups were noted for cognitive and language delays, or low performance-based overall executive function. However, infants randomized to dextrose gel had significantly higher risk of motor delay compared to placebo (2.5% vs. 0.7%) and significantly lower Bayley-III composite scores for cognitive, language, and motor performance.

No significant differences were noted between the groups in the areas of moderate or severe neurosensory impairment, hearing impairment, cerebral palsy, developmental delay, above-average development, socioemotional and adaptive behavior, questionnaire-based executive function, low visual processing, history of seizures, allergic and infectious diseases, growth, and body composition.

The results are consistent with previous studies on the safety of dextrose gel, the researchers wrote in their discussion. However, the absolute difference of 7% in the primary outcome may be clinically important, they noted. “Caution is warranted before using prophylactic dextrose gel,” they said.

The researchers noted the results of a dose-finding trial that suggested improved scores on language, executive function, and motor skills in unadjusted analysis with higher doses of dextrose gel, but the reason for these findings remains unknown, they said.

The study findings were limited by the potential underpowering to detect small, but significant differences, and possible lack of generalizability because the majority of the participants were children of mothers with diabetes.

The results were strengthened by the high follow-up rate and comprehensive assessments, and highlight the need for additional research with longer follow-up, the researchers said.
 

 

 

Findings fuel further exploration

Although hypoglycemia is common in newborns, its management and potential outcomes remain subjects for debate, Paul J. Rozance, MD, of the University of Colorado, Aurora, wrote in an editorial accompanying both studies.

“Often, the same features that increase the risk of hypoglycemia in newborns also increase the risk for poor outcomes independent of hypoglycemia,” he said.

The study by Shah and colleagues was not a randomized trial of a specific management strategy, Dr. Rozance noted. However, the high rate of low educational attainment in children not exposed to dextrose gel emphasizes the need for more effective management of infant hypoglycemia, he said. “The findings also suggest that antenatal conditions that are associated with increased risk of hypoglycemia among newborns are associated with increased risk for impaired neurodevelopment and educational achievement, independent of neonatal hypoglycemia,” he said. The study findings contrast with those of an earlier study showing low academic achievement association with early transient hypoglycemia, which could argue for earlier intervention, he noted.

The study by Edwards and colleagues addressed the potential value of dextrose gel as an early intervention to prevent neonatal hypoglycemia, said Dr. Rozance.

“The 95% CI for the primary outcome of neurosensory impairment included up to a 7% increased risk for neurosensory impairment in the prophylactic dextrose gel group. The 7% increased risk was defined by the investigators as potentially clinically important, and the study may have been underpowered to detect small differences in the primary outcome,” he wrote.

Although the reasons for adverse outcomes in children given prophylactic dextrose gel remain unclear, “incorporation of prophylactic dextrose gel into clinical practice should await further research,” he said.

Regarding such research, Dr. Rozance proposed an “ideal study,” that would “randomize newborns with hypoglycemia to treatment or no treatment, although equipoise and ethical support for such a study are lacking. Another strategy would be to randomize newborns with hypoglycemia to receive low- or high-treatment glucose concentration goals,” he noted.

The relationship between hypoglycemia and impaired neurodevelopment is yet to be determined, but the two studies provide new evidence for the clinical importance and need for management of neonatal hypoglycemia and subsequent neurodevelopmental outcomes, he concluded.

The study by Shah and colleagues was supported by the Health Research Council of New Zealand and the Maurice and Phyllis Paykel Trust. Dr. Shah disclosed a doctoral fellowship from the University of Auckland. The study by Edwards and colleagues was supported by the Health Research Council of New Zealand and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. Ms. Edwards had no financial conflicts to disclose. Dr. Rozance disclosed receiving a StatStrip from Nova Biomedical for use in his laboratory.

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Children at risk of neonatal hypoglycemia who were screened and treated if needed showed no difference in educational achievement from controls at age 9-10 years, based on data from 480 children.

Previous studies have shown an increased risk of poor executive and visual-motor function in children with neonatal hypoglycemia, but the effect on later childhood academic performance remains unclear, wrote Rajesh Shah, PhD, of the University of Auckland, New Zealand, and colleagues.

In a prospective cohort study published in JAMA, the researchers enrolled moderate to late preterm and term infants born at increased risk for hypoglycemia; those with episodes of hypoglycemia were treated to maintain a blood glucose concentration of at least 47 mg/dL.

The study population was enrolled between 2006 and 2010 at a regional perinatal center in New Zealand, and their educational achievement was assessed 9-10 years later. The primary outcome of low educational achievement was defined as performing below the normal curriculum level in standardized tests of reading comprehension or math. The researchers also identified 47 secondary outcomes related to executive function, visual-motor function, psychosocial adaptation, and general health.

Rates of low educational achievement were not significantly different for children with and without neonatal hypoglycemia (47% vs. 48%, adjusted risk ratio 0.95).

No significant differences appeared between the two groups for any secondary outcomes, including reading comprehension, math, behavior manifestations of executive function, fine motor function, autism traits, and overall well-being, the researchers noted.

However, children with neonatal hypoglycemia were significantly less likely to be rated as below or well below reading curriculum level by teachers compared to those without neonatal hypoglycemia (24% vs. 31%).

The researchers cited a previous study of the same patient cohort at age 4.5 years, which suggested an association between adverse neurodevelopmental outcomes and infant hypoglycemia. However, the reason this association did not persist at age 9-10 years remains unclear, the researchers wrote in their discussion. “Early disturbances in brain development may have diminishing effects over time due to neuroplasticity, that is, reorganization of neural networks, or delayed maturation with mid-childhood catch-up in neurocognitive function,” they said.

The study findings were limited by several factors including the lack of data on several measures of cognition, notably processing speed, and a lack of adjustment for intelligence quotient at age 4.5 years, the lack of data on any treatment for developmental impairment, and the inclusion of a population with well-managed hypoglycemia, the researchers said.

However, the results were strengthened by having a sample size large enough to detect associations, the prospective design, and the accurate measure of neonatal glycemic exposure, they said. Although the results suggest that at-risk children reach similar endpoints by the end of primary school, “efforts to prevent and optimize adverse pregnancy conditions remain important, and developmental surveillance after birth should be considered for at-risk infants,” they concluded.

In a related study published in JAMA, Taygen Edwards and colleagues found that prophylactic oral dextrose gel had no significant effect on neurosensory function.

The study, a prospective follow-up of a multicenter randomized trial, included 1,197 later preterm or term infants deemed at risk for neonatal hypoglycemia. The infants (49% of whom were female) were randomized to prophylactic 40% dextrose gel or a placebo, massaged into the buccal mucosa at 1 hour after birth.

The primary outcome was neurosensory impairment at 2 years of age, which was assessed by neurologic examination, parent-reported medical questionnaires, Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), performance-based executive function, Behavior Rating Inventory of Executive Function–Preschool Version, motion coherence thresholds, growth, and body composition.

At 2 years of age, the prevalence of neurosensory impairment was 21% and 19%, respectively, in infants randomized to prophylactic oral dextrose gel and placebo, a nonsignificant difference. No differences between the two groups were noted for cognitive and language delays, or low performance-based overall executive function. However, infants randomized to dextrose gel had significantly higher risk of motor delay compared to placebo (2.5% vs. 0.7%) and significantly lower Bayley-III composite scores for cognitive, language, and motor performance.

No significant differences were noted between the groups in the areas of moderate or severe neurosensory impairment, hearing impairment, cerebral palsy, developmental delay, above-average development, socioemotional and adaptive behavior, questionnaire-based executive function, low visual processing, history of seizures, allergic and infectious diseases, growth, and body composition.

The results are consistent with previous studies on the safety of dextrose gel, the researchers wrote in their discussion. However, the absolute difference of 7% in the primary outcome may be clinically important, they noted. “Caution is warranted before using prophylactic dextrose gel,” they said.

The researchers noted the results of a dose-finding trial that suggested improved scores on language, executive function, and motor skills in unadjusted analysis with higher doses of dextrose gel, but the reason for these findings remains unknown, they said.

The study findings were limited by the potential underpowering to detect small, but significant differences, and possible lack of generalizability because the majority of the participants were children of mothers with diabetes.

The results were strengthened by the high follow-up rate and comprehensive assessments, and highlight the need for additional research with longer follow-up, the researchers said.
 

 

 

Findings fuel further exploration

Although hypoglycemia is common in newborns, its management and potential outcomes remain subjects for debate, Paul J. Rozance, MD, of the University of Colorado, Aurora, wrote in an editorial accompanying both studies.

“Often, the same features that increase the risk of hypoglycemia in newborns also increase the risk for poor outcomes independent of hypoglycemia,” he said.

The study by Shah and colleagues was not a randomized trial of a specific management strategy, Dr. Rozance noted. However, the high rate of low educational attainment in children not exposed to dextrose gel emphasizes the need for more effective management of infant hypoglycemia, he said. “The findings also suggest that antenatal conditions that are associated with increased risk of hypoglycemia among newborns are associated with increased risk for impaired neurodevelopment and educational achievement, independent of neonatal hypoglycemia,” he said. The study findings contrast with those of an earlier study showing low academic achievement association with early transient hypoglycemia, which could argue for earlier intervention, he noted.

The study by Edwards and colleagues addressed the potential value of dextrose gel as an early intervention to prevent neonatal hypoglycemia, said Dr. Rozance.

“The 95% CI for the primary outcome of neurosensory impairment included up to a 7% increased risk for neurosensory impairment in the prophylactic dextrose gel group. The 7% increased risk was defined by the investigators as potentially clinically important, and the study may have been underpowered to detect small differences in the primary outcome,” he wrote.

Although the reasons for adverse outcomes in children given prophylactic dextrose gel remain unclear, “incorporation of prophylactic dextrose gel into clinical practice should await further research,” he said.

Regarding such research, Dr. Rozance proposed an “ideal study,” that would “randomize newborns with hypoglycemia to treatment or no treatment, although equipoise and ethical support for such a study are lacking. Another strategy would be to randomize newborns with hypoglycemia to receive low- or high-treatment glucose concentration goals,” he noted.

The relationship between hypoglycemia and impaired neurodevelopment is yet to be determined, but the two studies provide new evidence for the clinical importance and need for management of neonatal hypoglycemia and subsequent neurodevelopmental outcomes, he concluded.

The study by Shah and colleagues was supported by the Health Research Council of New Zealand and the Maurice and Phyllis Paykel Trust. Dr. Shah disclosed a doctoral fellowship from the University of Auckland. The study by Edwards and colleagues was supported by the Health Research Council of New Zealand and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. Ms. Edwards had no financial conflicts to disclose. Dr. Rozance disclosed receiving a StatStrip from Nova Biomedical for use in his laboratory.

Children at risk of neonatal hypoglycemia who were screened and treated if needed showed no difference in educational achievement from controls at age 9-10 years, based on data from 480 children.

Previous studies have shown an increased risk of poor executive and visual-motor function in children with neonatal hypoglycemia, but the effect on later childhood academic performance remains unclear, wrote Rajesh Shah, PhD, of the University of Auckland, New Zealand, and colleagues.

In a prospective cohort study published in JAMA, the researchers enrolled moderate to late preterm and term infants born at increased risk for hypoglycemia; those with episodes of hypoglycemia were treated to maintain a blood glucose concentration of at least 47 mg/dL.

The study population was enrolled between 2006 and 2010 at a regional perinatal center in New Zealand, and their educational achievement was assessed 9-10 years later. The primary outcome of low educational achievement was defined as performing below the normal curriculum level in standardized tests of reading comprehension or math. The researchers also identified 47 secondary outcomes related to executive function, visual-motor function, psychosocial adaptation, and general health.

Rates of low educational achievement were not significantly different for children with and without neonatal hypoglycemia (47% vs. 48%, adjusted risk ratio 0.95).

No significant differences appeared between the two groups for any secondary outcomes, including reading comprehension, math, behavior manifestations of executive function, fine motor function, autism traits, and overall well-being, the researchers noted.

However, children with neonatal hypoglycemia were significantly less likely to be rated as below or well below reading curriculum level by teachers compared to those without neonatal hypoglycemia (24% vs. 31%).

The researchers cited a previous study of the same patient cohort at age 4.5 years, which suggested an association between adverse neurodevelopmental outcomes and infant hypoglycemia. However, the reason this association did not persist at age 9-10 years remains unclear, the researchers wrote in their discussion. “Early disturbances in brain development may have diminishing effects over time due to neuroplasticity, that is, reorganization of neural networks, or delayed maturation with mid-childhood catch-up in neurocognitive function,” they said.

The study findings were limited by several factors including the lack of data on several measures of cognition, notably processing speed, and a lack of adjustment for intelligence quotient at age 4.5 years, the lack of data on any treatment for developmental impairment, and the inclusion of a population with well-managed hypoglycemia, the researchers said.

However, the results were strengthened by having a sample size large enough to detect associations, the prospective design, and the accurate measure of neonatal glycemic exposure, they said. Although the results suggest that at-risk children reach similar endpoints by the end of primary school, “efforts to prevent and optimize adverse pregnancy conditions remain important, and developmental surveillance after birth should be considered for at-risk infants,” they concluded.

In a related study published in JAMA, Taygen Edwards and colleagues found that prophylactic oral dextrose gel had no significant effect on neurosensory function.

The study, a prospective follow-up of a multicenter randomized trial, included 1,197 later preterm or term infants deemed at risk for neonatal hypoglycemia. The infants (49% of whom were female) were randomized to prophylactic 40% dextrose gel or a placebo, massaged into the buccal mucosa at 1 hour after birth.

The primary outcome was neurosensory impairment at 2 years of age, which was assessed by neurologic examination, parent-reported medical questionnaires, Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), performance-based executive function, Behavior Rating Inventory of Executive Function–Preschool Version, motion coherence thresholds, growth, and body composition.

At 2 years of age, the prevalence of neurosensory impairment was 21% and 19%, respectively, in infants randomized to prophylactic oral dextrose gel and placebo, a nonsignificant difference. No differences between the two groups were noted for cognitive and language delays, or low performance-based overall executive function. However, infants randomized to dextrose gel had significantly higher risk of motor delay compared to placebo (2.5% vs. 0.7%) and significantly lower Bayley-III composite scores for cognitive, language, and motor performance.

No significant differences were noted between the groups in the areas of moderate or severe neurosensory impairment, hearing impairment, cerebral palsy, developmental delay, above-average development, socioemotional and adaptive behavior, questionnaire-based executive function, low visual processing, history of seizures, allergic and infectious diseases, growth, and body composition.

The results are consistent with previous studies on the safety of dextrose gel, the researchers wrote in their discussion. However, the absolute difference of 7% in the primary outcome may be clinically important, they noted. “Caution is warranted before using prophylactic dextrose gel,” they said.

The researchers noted the results of a dose-finding trial that suggested improved scores on language, executive function, and motor skills in unadjusted analysis with higher doses of dextrose gel, but the reason for these findings remains unknown, they said.

The study findings were limited by the potential underpowering to detect small, but significant differences, and possible lack of generalizability because the majority of the participants were children of mothers with diabetes.

The results were strengthened by the high follow-up rate and comprehensive assessments, and highlight the need for additional research with longer follow-up, the researchers said.
 

 

 

Findings fuel further exploration

Although hypoglycemia is common in newborns, its management and potential outcomes remain subjects for debate, Paul J. Rozance, MD, of the University of Colorado, Aurora, wrote in an editorial accompanying both studies.

“Often, the same features that increase the risk of hypoglycemia in newborns also increase the risk for poor outcomes independent of hypoglycemia,” he said.

The study by Shah and colleagues was not a randomized trial of a specific management strategy, Dr. Rozance noted. However, the high rate of low educational attainment in children not exposed to dextrose gel emphasizes the need for more effective management of infant hypoglycemia, he said. “The findings also suggest that antenatal conditions that are associated with increased risk of hypoglycemia among newborns are associated with increased risk for impaired neurodevelopment and educational achievement, independent of neonatal hypoglycemia,” he said. The study findings contrast with those of an earlier study showing low academic achievement association with early transient hypoglycemia, which could argue for earlier intervention, he noted.

The study by Edwards and colleagues addressed the potential value of dextrose gel as an early intervention to prevent neonatal hypoglycemia, said Dr. Rozance.

“The 95% CI for the primary outcome of neurosensory impairment included up to a 7% increased risk for neurosensory impairment in the prophylactic dextrose gel group. The 7% increased risk was defined by the investigators as potentially clinically important, and the study may have been underpowered to detect small differences in the primary outcome,” he wrote.

Although the reasons for adverse outcomes in children given prophylactic dextrose gel remain unclear, “incorporation of prophylactic dextrose gel into clinical practice should await further research,” he said.

Regarding such research, Dr. Rozance proposed an “ideal study,” that would “randomize newborns with hypoglycemia to treatment or no treatment, although equipoise and ethical support for such a study are lacking. Another strategy would be to randomize newborns with hypoglycemia to receive low- or high-treatment glucose concentration goals,” he noted.

The relationship between hypoglycemia and impaired neurodevelopment is yet to be determined, but the two studies provide new evidence for the clinical importance and need for management of neonatal hypoglycemia and subsequent neurodevelopmental outcomes, he concluded.

The study by Shah and colleagues was supported by the Health Research Council of New Zealand and the Maurice and Phyllis Paykel Trust. Dr. Shah disclosed a doctoral fellowship from the University of Auckland. The study by Edwards and colleagues was supported by the Health Research Council of New Zealand and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. Ms. Edwards had no financial conflicts to disclose. Dr. Rozance disclosed receiving a StatStrip from Nova Biomedical for use in his laboratory.

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What a sleep expert thinks of sleep trackers

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The pandemic not only disrupted sleep but may have also triggered an uptick in the use of wearable tech. Sleep tracking was featured at the Cardiovascular Health Tech virtual conference 2022, sponsored by the Institute of Electrical and Electronics Engineers Engineering in Medicine & Biology Society technical committee on Cardiopulmonary Systems and Physiology-Based Engineering.

This news organization interviewed presenter Kelly Glazer Baron, PhD, MPH, DBSM, an associate professor at the University of Utah, Salt Lake City, and a clinical psychologist specializing in behavioral sleep medicine.

The interview has been edited for length and clarity.
 

Question: Are consumer sleep trackers mainly divided into “nearables” – things that you put at the side of the bed or under the pillow – vs. wearables?

Dr. Baron:
There are so many different devices these days. There are things that you put under your mattress or pillow; there are bedside recording devices; then there are headbands, rings, wrist-worn, all kinds of things.

Q: At the conference, Philip de Chazal, PhD, (University of Sydney) described the evidence on sleep tracking smartphone apps as woeful. Would you agree with that?

A:
Yes. I would agree if you’re looking at how accurate they are at recording sleep, particularly compared with what we would define as the gold standard, which is a sleep study wherein you have electrodes on the scalp and you’re measuring the electrical activity directly.

Devices that go under the pillow are extremely poor at deciphering sleep from wake time, which is really the main goal. They are best at detecting when you get into the bed and when you get out. But even then, there isn’t good evidence that they do that accurately when there are two people in the bed.

Overall, they may give you a general gist of what’s happening in terms of time in and out of bed, but we’re doubtful on their recording ability to tell sleep from wake time.
 

Q: Are the wrist-worn devices better for sleep tracking?

A:
They’re getting better. We’ve used wrist activity monitors in research for years. They use an accelerometer to measure movement, and then an algorithm determines whether an interval of time is called sleep or wake.

Recently, they’ve incorporated more sensors, such as heart rate, and they can more accurately decipher rapid eye movement (REM) sleep from non-REM. They’re still not as good as doing a full sleep study. But they’re getting closer.
 

Q: If asked how you slept, most of us think we can answer without needing to look at a smartphone, but maybe not. Can you explain “paradoxical insomnia”?

A:
You can’t really know if you’re sleeping because if you know you’re asleep, then you can’t be asleep because it’s a state of unconsciousness. How people decide whether they had a good night’s sleep probably depends on a lot of things about how they feel when they wake up in the morning or if they remember being up in the night.

Quality of sleep is not really something that people can directly ascertain. There is a selection of people who feel awake all night but they actually are sleeping. They feel that their sleep quality is poor: They’re suffering; they have insomnia, but from the objective data, they are sleeping fine.
 

 

 

Q: Is this related to non-REM stage 1 sleep, when you may not be aware that you’re asleep?

A:
No. I’m talking about people who come into the sleep lab for an overnight study and get hooked up. And in the morning, they’ll tell the tech I was awake all night, but the tech will see that their sleep was just fine.

There is a disconnect between how people perceive their sleep and how they actually sleep. For most people it’s impossible to be completely accurate to know how much you’re sleeping. Then there are some people who perceive it very differently.

Sleep trackers don’t have the level of detail of sleep studies that use scalp electrodes. When we get into the details of sleep measurement, we’re measuring 30-second epochs (sampling periods), where we look at broad measures of electrical activity. There is even more detail there that can be pulled out using other techniques, such as analyzing the spectrum of the EEG. For example, some studies have found a beta frequency in the EEG of people with insomnia, so even though they are sleeping, they often feel awake.

Basically, the subjective experience of sleep somewhat overlaps with the objective recording of what’s happening on a sleep study, but not completely.
 

Q: You said that first thing in the morning might not be the best time to assess your sleep – if you wake up groggy and are already thinking, “The day is shot.”

A:
In general, people really feel worst in the morning. Their circadian drive is low, especially if they’re a little sleep deprived. You shouldn’t judge the day on the first hour after waking – most people are pretty cognitively impaired. I tell people they need some boot-up time.

You feel differently as the day goes on and even at different points of the day. There’s a lull in the early afternoon because of your circadian dip and then we get a second wind in the evening. How you feel isn’t one flat line; it’s really a rhythm throughout the day
 

Q: Would you say that consumer sleep trackers are okay for individuals to use to see a pattern but are maybe not accurate enough to use more globally in research?

A:
I think there is a huge opportunity to understand sleep at a population level. For example, if there’s been a hurricane or an earthquake or Superbowl Sunday, companies have an opportunity to look at the impact – say, daylight saving time and how it affects sleep across different countries, or men vs. women, or different age groups.

There was a paper about sleep among hospital workers in Wuhan during the outbreak of the pandemic. That was a creative use of wearable devices to look at sleep in a large population.

Now, of course, the devices are not given out randomly; the people who buy them are probably a little bit healthier, maybe a little bit younger – that sort of thing. It is a biased sample.
 

 

 

Q: As you note, mobile health trackers tend to be used by the “worried well.” Can you tell us about your paper that introduced the term “orthosomnia,” or “a perfectionistic quest for the ideal sleep in order to optimize daytime function”?

A: As these devices came out, more people were coming into the clinic and shoving their data in front of us saying, “I don’t feel well, and I don’t sleep 7 hours.” They were focused on this specific number. Back when we wrote this paper, the devices were primarily movement based (now the devices are a bit more accurate). Some would say, “My sleep is light, and it’s not deep.” We’d do a sleep study that showed that they have deep sleep, but they would still believe their device even though the device really wasn’t able to classify sleep accurately.

We even found people making their sleep worse because of the device. For example, trying to get the number higher by spending more time lying in bed trying to sleep which is the opposite of what you want someone with insomnia to do. These people held the data so tight and really felt that it characterized their experience, even though we sleep medicine practitioners didn’t find it very accurate and felt that it was somewhat unhelpful to their treatment.
 

Q: What advice would you give the harried primary care physician presented with a patient’s hypnogram or sleep pattern?

A:
As someone once pointed out to me, it’s a conversation opener about their sleep. Did they buy the device because they’re worried about their sleep? It’s unlikely that you can glean anything clinically useful from the data.

I briefly look at it to see the duration of their sleep, the regularity in their sleep pattern – the pattern of awakenings during the night might suggest that they have some insomnia. But it doesn’t take the place of clinical assessment for conditions like sleep apnea: Are they snoring? Are they unrefreshed?

I had a patient in the orthosomnia study who was given a sleep tracker by a family member. He brought the data to his doctor who ordered a sleep study that found he had sleep apnea. He would say, “The device diagnosed my sleep apnea.” But that wasn’t actually the case; it just opened the conversation and the clinician said, “Well, let’s order a sleep study.”
 

Q: The device told him he wasn’t getting much sleep and then the sleep study told him it was apnea.

A: Right. It’s impossible to pick up sleep apnea. Some of the latest devices have some oximetry reading but it is not a clinically validated oximetry that could diagnose sleep apnea.

When these first came out I thought I’d get more referrals. So far, I haven’t had a single person come in and ask if they have sleep apnea. If you have a patient saying, “Hey, I’m worried about my oxygen level and here’s my data,” then the clinician should consider whether they need a sleep study for sleep apnea.
 

 

 

Q: You did a survey that suggests that clinicians are less keen on these devices than consumers. Conor Heneghan of Fitbit/Google also mentioned a study using the Fitbit Charge and a SleepLife portal. The patients were very engaged but only one physician (out of 49) logged into the portal to look at the data.

A:
Our survey of sleep professionals (which we need to publish) showed that they were wary of the data. They found it frustrating in some ways because it took time out of the clinical encounter.

Some of them said that parents are putting trackers on their children and then catastrophizing their children’s sleep.
 

Q: Is there such a thing as an ideal hypnogram or does it vary by individual?

A:
I would say that it depends on a lot of things. If you think about a hypnogram from a sleep study, the patient is not sleeping in their home environment, and it’s only one night. There’s a range of what would be considered normal, and it’s related to your sex and your age.

One night is not going to be sufficient to characterize your percentage in this or that sleep stage. Our patients come in saying, “I’m not getting enough REM.” But there isn’t a sleep disorder called lack of REM; there’s no treatment for that. It’s probably pretty normal for them or maybe they’re taking medications that suppress their REM, such as antidepressants.

The tech world is very interested to sense REM properly and to display it. But on the treatment side of things, there’s not much that we do with that data. We’re more interested in the consolidation of their sleep, the duration of their sleep, breathing-related sleep disorders, those sorts of things.
 

Q: Is there any reason to be concerned about the amount of REM sleep in terms of outcomes? We know that poor sleep can lead to bad cardiovascular outcomes, but has any of that correlated to sleep stage?

A:
There are studies where they’ve experimentally deprived people of certain stages of sleep, but they’re not very useful in the real world. We’re looking at sleep holistically: Do you have a good sleep pattern? Any breathing-related sleep disorders? Insomnia? We don’t treat sleep by the stage.

Q: Any concern that people who are focused on a device may be ignoring the basic tenets of good sleep hygiene?

A:
If people are doing things that are obviously bad for their sleep, like working too late, not exercising enough, sleeping in on weekends to compensate for being up late during the week, or probably the biggest thing contributing to insomnia – stress. A device itself won’t fix those things but it could show you the evidence.

If somebody really has a sleep disorder, then sleep hygiene alone is probably not going to be enough. They’re going to need to engage in a more extensive program to improve their sleep, such as cognitive-behavioral therapy for insomnia.
 

Q: Is there anything else you want to mention?

A:
I don’t want to leave with a reputation of being against sleep trackers. I think they are a great opportunity for people to get excited about and learn about their sleep and try to improve it. We have a lot to learn about what people want from their data and how we can use that data to improve people’s sleep.

As providers, we can engage with our patients – sleep is an automatic process, but improving sleep takes some effort. Buying a device is not going to automatically make you sleep better. It takes work to establish a better sleep pattern; it may require some cognitive-behavioral therapy or treating a sleep disorder. That takes some work.

Dr. Baron reported no conflicts of interest.A version of this article first appeared on Medscape.com.

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The pandemic not only disrupted sleep but may have also triggered an uptick in the use of wearable tech. Sleep tracking was featured at the Cardiovascular Health Tech virtual conference 2022, sponsored by the Institute of Electrical and Electronics Engineers Engineering in Medicine & Biology Society technical committee on Cardiopulmonary Systems and Physiology-Based Engineering.

This news organization interviewed presenter Kelly Glazer Baron, PhD, MPH, DBSM, an associate professor at the University of Utah, Salt Lake City, and a clinical psychologist specializing in behavioral sleep medicine.

The interview has been edited for length and clarity.
 

Question: Are consumer sleep trackers mainly divided into “nearables” – things that you put at the side of the bed or under the pillow – vs. wearables?

Dr. Baron:
There are so many different devices these days. There are things that you put under your mattress or pillow; there are bedside recording devices; then there are headbands, rings, wrist-worn, all kinds of things.

Q: At the conference, Philip de Chazal, PhD, (University of Sydney) described the evidence on sleep tracking smartphone apps as woeful. Would you agree with that?

A:
Yes. I would agree if you’re looking at how accurate they are at recording sleep, particularly compared with what we would define as the gold standard, which is a sleep study wherein you have electrodes on the scalp and you’re measuring the electrical activity directly.

Devices that go under the pillow are extremely poor at deciphering sleep from wake time, which is really the main goal. They are best at detecting when you get into the bed and when you get out. But even then, there isn’t good evidence that they do that accurately when there are two people in the bed.

Overall, they may give you a general gist of what’s happening in terms of time in and out of bed, but we’re doubtful on their recording ability to tell sleep from wake time.
 

Q: Are the wrist-worn devices better for sleep tracking?

A:
They’re getting better. We’ve used wrist activity monitors in research for years. They use an accelerometer to measure movement, and then an algorithm determines whether an interval of time is called sleep or wake.

Recently, they’ve incorporated more sensors, such as heart rate, and they can more accurately decipher rapid eye movement (REM) sleep from non-REM. They’re still not as good as doing a full sleep study. But they’re getting closer.
 

Q: If asked how you slept, most of us think we can answer without needing to look at a smartphone, but maybe not. Can you explain “paradoxical insomnia”?

A:
You can’t really know if you’re sleeping because if you know you’re asleep, then you can’t be asleep because it’s a state of unconsciousness. How people decide whether they had a good night’s sleep probably depends on a lot of things about how they feel when they wake up in the morning or if they remember being up in the night.

Quality of sleep is not really something that people can directly ascertain. There is a selection of people who feel awake all night but they actually are sleeping. They feel that their sleep quality is poor: They’re suffering; they have insomnia, but from the objective data, they are sleeping fine.
 

 

 

Q: Is this related to non-REM stage 1 sleep, when you may not be aware that you’re asleep?

A:
No. I’m talking about people who come into the sleep lab for an overnight study and get hooked up. And in the morning, they’ll tell the tech I was awake all night, but the tech will see that their sleep was just fine.

There is a disconnect between how people perceive their sleep and how they actually sleep. For most people it’s impossible to be completely accurate to know how much you’re sleeping. Then there are some people who perceive it very differently.

Sleep trackers don’t have the level of detail of sleep studies that use scalp electrodes. When we get into the details of sleep measurement, we’re measuring 30-second epochs (sampling periods), where we look at broad measures of electrical activity. There is even more detail there that can be pulled out using other techniques, such as analyzing the spectrum of the EEG. For example, some studies have found a beta frequency in the EEG of people with insomnia, so even though they are sleeping, they often feel awake.

Basically, the subjective experience of sleep somewhat overlaps with the objective recording of what’s happening on a sleep study, but not completely.
 

Q: You said that first thing in the morning might not be the best time to assess your sleep – if you wake up groggy and are already thinking, “The day is shot.”

A:
In general, people really feel worst in the morning. Their circadian drive is low, especially if they’re a little sleep deprived. You shouldn’t judge the day on the first hour after waking – most people are pretty cognitively impaired. I tell people they need some boot-up time.

You feel differently as the day goes on and even at different points of the day. There’s a lull in the early afternoon because of your circadian dip and then we get a second wind in the evening. How you feel isn’t one flat line; it’s really a rhythm throughout the day
 

Q: Would you say that consumer sleep trackers are okay for individuals to use to see a pattern but are maybe not accurate enough to use more globally in research?

A:
I think there is a huge opportunity to understand sleep at a population level. For example, if there’s been a hurricane or an earthquake or Superbowl Sunday, companies have an opportunity to look at the impact – say, daylight saving time and how it affects sleep across different countries, or men vs. women, or different age groups.

There was a paper about sleep among hospital workers in Wuhan during the outbreak of the pandemic. That was a creative use of wearable devices to look at sleep in a large population.

Now, of course, the devices are not given out randomly; the people who buy them are probably a little bit healthier, maybe a little bit younger – that sort of thing. It is a biased sample.
 

 

 

Q: As you note, mobile health trackers tend to be used by the “worried well.” Can you tell us about your paper that introduced the term “orthosomnia,” or “a perfectionistic quest for the ideal sleep in order to optimize daytime function”?

A: As these devices came out, more people were coming into the clinic and shoving their data in front of us saying, “I don’t feel well, and I don’t sleep 7 hours.” They were focused on this specific number. Back when we wrote this paper, the devices were primarily movement based (now the devices are a bit more accurate). Some would say, “My sleep is light, and it’s not deep.” We’d do a sleep study that showed that they have deep sleep, but they would still believe their device even though the device really wasn’t able to classify sleep accurately.

We even found people making their sleep worse because of the device. For example, trying to get the number higher by spending more time lying in bed trying to sleep which is the opposite of what you want someone with insomnia to do. These people held the data so tight and really felt that it characterized their experience, even though we sleep medicine practitioners didn’t find it very accurate and felt that it was somewhat unhelpful to their treatment.
 

Q: What advice would you give the harried primary care physician presented with a patient’s hypnogram or sleep pattern?

A:
As someone once pointed out to me, it’s a conversation opener about their sleep. Did they buy the device because they’re worried about their sleep? It’s unlikely that you can glean anything clinically useful from the data.

I briefly look at it to see the duration of their sleep, the regularity in their sleep pattern – the pattern of awakenings during the night might suggest that they have some insomnia. But it doesn’t take the place of clinical assessment for conditions like sleep apnea: Are they snoring? Are they unrefreshed?

I had a patient in the orthosomnia study who was given a sleep tracker by a family member. He brought the data to his doctor who ordered a sleep study that found he had sleep apnea. He would say, “The device diagnosed my sleep apnea.” But that wasn’t actually the case; it just opened the conversation and the clinician said, “Well, let’s order a sleep study.”
 

Q: The device told him he wasn’t getting much sleep and then the sleep study told him it was apnea.

A: Right. It’s impossible to pick up sleep apnea. Some of the latest devices have some oximetry reading but it is not a clinically validated oximetry that could diagnose sleep apnea.

When these first came out I thought I’d get more referrals. So far, I haven’t had a single person come in and ask if they have sleep apnea. If you have a patient saying, “Hey, I’m worried about my oxygen level and here’s my data,” then the clinician should consider whether they need a sleep study for sleep apnea.
 

 

 

Q: You did a survey that suggests that clinicians are less keen on these devices than consumers. Conor Heneghan of Fitbit/Google also mentioned a study using the Fitbit Charge and a SleepLife portal. The patients were very engaged but only one physician (out of 49) logged into the portal to look at the data.

A:
Our survey of sleep professionals (which we need to publish) showed that they were wary of the data. They found it frustrating in some ways because it took time out of the clinical encounter.

Some of them said that parents are putting trackers on their children and then catastrophizing their children’s sleep.
 

Q: Is there such a thing as an ideal hypnogram or does it vary by individual?

A:
I would say that it depends on a lot of things. If you think about a hypnogram from a sleep study, the patient is not sleeping in their home environment, and it’s only one night. There’s a range of what would be considered normal, and it’s related to your sex and your age.

One night is not going to be sufficient to characterize your percentage in this or that sleep stage. Our patients come in saying, “I’m not getting enough REM.” But there isn’t a sleep disorder called lack of REM; there’s no treatment for that. It’s probably pretty normal for them or maybe they’re taking medications that suppress their REM, such as antidepressants.

The tech world is very interested to sense REM properly and to display it. But on the treatment side of things, there’s not much that we do with that data. We’re more interested in the consolidation of their sleep, the duration of their sleep, breathing-related sleep disorders, those sorts of things.
 

Q: Is there any reason to be concerned about the amount of REM sleep in terms of outcomes? We know that poor sleep can lead to bad cardiovascular outcomes, but has any of that correlated to sleep stage?

A:
There are studies where they’ve experimentally deprived people of certain stages of sleep, but they’re not very useful in the real world. We’re looking at sleep holistically: Do you have a good sleep pattern? Any breathing-related sleep disorders? Insomnia? We don’t treat sleep by the stage.

Q: Any concern that people who are focused on a device may be ignoring the basic tenets of good sleep hygiene?

A:
If people are doing things that are obviously bad for their sleep, like working too late, not exercising enough, sleeping in on weekends to compensate for being up late during the week, or probably the biggest thing contributing to insomnia – stress. A device itself won’t fix those things but it could show you the evidence.

If somebody really has a sleep disorder, then sleep hygiene alone is probably not going to be enough. They’re going to need to engage in a more extensive program to improve their sleep, such as cognitive-behavioral therapy for insomnia.
 

Q: Is there anything else you want to mention?

A:
I don’t want to leave with a reputation of being against sleep trackers. I think they are a great opportunity for people to get excited about and learn about their sleep and try to improve it. We have a lot to learn about what people want from their data and how we can use that data to improve people’s sleep.

As providers, we can engage with our patients – sleep is an automatic process, but improving sleep takes some effort. Buying a device is not going to automatically make you sleep better. It takes work to establish a better sleep pattern; it may require some cognitive-behavioral therapy or treating a sleep disorder. That takes some work.

Dr. Baron reported no conflicts of interest.A version of this article first appeared on Medscape.com.

The pandemic not only disrupted sleep but may have also triggered an uptick in the use of wearable tech. Sleep tracking was featured at the Cardiovascular Health Tech virtual conference 2022, sponsored by the Institute of Electrical and Electronics Engineers Engineering in Medicine & Biology Society technical committee on Cardiopulmonary Systems and Physiology-Based Engineering.

This news organization interviewed presenter Kelly Glazer Baron, PhD, MPH, DBSM, an associate professor at the University of Utah, Salt Lake City, and a clinical psychologist specializing in behavioral sleep medicine.

The interview has been edited for length and clarity.
 

Question: Are consumer sleep trackers mainly divided into “nearables” – things that you put at the side of the bed or under the pillow – vs. wearables?

Dr. Baron:
There are so many different devices these days. There are things that you put under your mattress or pillow; there are bedside recording devices; then there are headbands, rings, wrist-worn, all kinds of things.

Q: At the conference, Philip de Chazal, PhD, (University of Sydney) described the evidence on sleep tracking smartphone apps as woeful. Would you agree with that?

A:
Yes. I would agree if you’re looking at how accurate they are at recording sleep, particularly compared with what we would define as the gold standard, which is a sleep study wherein you have electrodes on the scalp and you’re measuring the electrical activity directly.

Devices that go under the pillow are extremely poor at deciphering sleep from wake time, which is really the main goal. They are best at detecting when you get into the bed and when you get out. But even then, there isn’t good evidence that they do that accurately when there are two people in the bed.

Overall, they may give you a general gist of what’s happening in terms of time in and out of bed, but we’re doubtful on their recording ability to tell sleep from wake time.
 

Q: Are the wrist-worn devices better for sleep tracking?

A:
They’re getting better. We’ve used wrist activity monitors in research for years. They use an accelerometer to measure movement, and then an algorithm determines whether an interval of time is called sleep or wake.

Recently, they’ve incorporated more sensors, such as heart rate, and they can more accurately decipher rapid eye movement (REM) sleep from non-REM. They’re still not as good as doing a full sleep study. But they’re getting closer.
 

Q: If asked how you slept, most of us think we can answer without needing to look at a smartphone, but maybe not. Can you explain “paradoxical insomnia”?

A:
You can’t really know if you’re sleeping because if you know you’re asleep, then you can’t be asleep because it’s a state of unconsciousness. How people decide whether they had a good night’s sleep probably depends on a lot of things about how they feel when they wake up in the morning or if they remember being up in the night.

Quality of sleep is not really something that people can directly ascertain. There is a selection of people who feel awake all night but they actually are sleeping. They feel that their sleep quality is poor: They’re suffering; they have insomnia, but from the objective data, they are sleeping fine.
 

 

 

Q: Is this related to non-REM stage 1 sleep, when you may not be aware that you’re asleep?

A:
No. I’m talking about people who come into the sleep lab for an overnight study and get hooked up. And in the morning, they’ll tell the tech I was awake all night, but the tech will see that their sleep was just fine.

There is a disconnect between how people perceive their sleep and how they actually sleep. For most people it’s impossible to be completely accurate to know how much you’re sleeping. Then there are some people who perceive it very differently.

Sleep trackers don’t have the level of detail of sleep studies that use scalp electrodes. When we get into the details of sleep measurement, we’re measuring 30-second epochs (sampling periods), where we look at broad measures of electrical activity. There is even more detail there that can be pulled out using other techniques, such as analyzing the spectrum of the EEG. For example, some studies have found a beta frequency in the EEG of people with insomnia, so even though they are sleeping, they often feel awake.

Basically, the subjective experience of sleep somewhat overlaps with the objective recording of what’s happening on a sleep study, but not completely.
 

Q: You said that first thing in the morning might not be the best time to assess your sleep – if you wake up groggy and are already thinking, “The day is shot.”

A:
In general, people really feel worst in the morning. Their circadian drive is low, especially if they’re a little sleep deprived. You shouldn’t judge the day on the first hour after waking – most people are pretty cognitively impaired. I tell people they need some boot-up time.

You feel differently as the day goes on and even at different points of the day. There’s a lull in the early afternoon because of your circadian dip and then we get a second wind in the evening. How you feel isn’t one flat line; it’s really a rhythm throughout the day
 

Q: Would you say that consumer sleep trackers are okay for individuals to use to see a pattern but are maybe not accurate enough to use more globally in research?

A:
I think there is a huge opportunity to understand sleep at a population level. For example, if there’s been a hurricane or an earthquake or Superbowl Sunday, companies have an opportunity to look at the impact – say, daylight saving time and how it affects sleep across different countries, or men vs. women, or different age groups.

There was a paper about sleep among hospital workers in Wuhan during the outbreak of the pandemic. That was a creative use of wearable devices to look at sleep in a large population.

Now, of course, the devices are not given out randomly; the people who buy them are probably a little bit healthier, maybe a little bit younger – that sort of thing. It is a biased sample.
 

 

 

Q: As you note, mobile health trackers tend to be used by the “worried well.” Can you tell us about your paper that introduced the term “orthosomnia,” or “a perfectionistic quest for the ideal sleep in order to optimize daytime function”?

A: As these devices came out, more people were coming into the clinic and shoving their data in front of us saying, “I don’t feel well, and I don’t sleep 7 hours.” They were focused on this specific number. Back when we wrote this paper, the devices were primarily movement based (now the devices are a bit more accurate). Some would say, “My sleep is light, and it’s not deep.” We’d do a sleep study that showed that they have deep sleep, but they would still believe their device even though the device really wasn’t able to classify sleep accurately.

We even found people making their sleep worse because of the device. For example, trying to get the number higher by spending more time lying in bed trying to sleep which is the opposite of what you want someone with insomnia to do. These people held the data so tight and really felt that it characterized their experience, even though we sleep medicine practitioners didn’t find it very accurate and felt that it was somewhat unhelpful to their treatment.
 

Q: What advice would you give the harried primary care physician presented with a patient’s hypnogram or sleep pattern?

A:
As someone once pointed out to me, it’s a conversation opener about their sleep. Did they buy the device because they’re worried about their sleep? It’s unlikely that you can glean anything clinically useful from the data.

I briefly look at it to see the duration of their sleep, the regularity in their sleep pattern – the pattern of awakenings during the night might suggest that they have some insomnia. But it doesn’t take the place of clinical assessment for conditions like sleep apnea: Are they snoring? Are they unrefreshed?

I had a patient in the orthosomnia study who was given a sleep tracker by a family member. He brought the data to his doctor who ordered a sleep study that found he had sleep apnea. He would say, “The device diagnosed my sleep apnea.” But that wasn’t actually the case; it just opened the conversation and the clinician said, “Well, let’s order a sleep study.”
 

Q: The device told him he wasn’t getting much sleep and then the sleep study told him it was apnea.

A: Right. It’s impossible to pick up sleep apnea. Some of the latest devices have some oximetry reading but it is not a clinically validated oximetry that could diagnose sleep apnea.

When these first came out I thought I’d get more referrals. So far, I haven’t had a single person come in and ask if they have sleep apnea. If you have a patient saying, “Hey, I’m worried about my oxygen level and here’s my data,” then the clinician should consider whether they need a sleep study for sleep apnea.
 

 

 

Q: You did a survey that suggests that clinicians are less keen on these devices than consumers. Conor Heneghan of Fitbit/Google also mentioned a study using the Fitbit Charge and a SleepLife portal. The patients were very engaged but only one physician (out of 49) logged into the portal to look at the data.

A:
Our survey of sleep professionals (which we need to publish) showed that they were wary of the data. They found it frustrating in some ways because it took time out of the clinical encounter.

Some of them said that parents are putting trackers on their children and then catastrophizing their children’s sleep.
 

Q: Is there such a thing as an ideal hypnogram or does it vary by individual?

A:
I would say that it depends on a lot of things. If you think about a hypnogram from a sleep study, the patient is not sleeping in their home environment, and it’s only one night. There’s a range of what would be considered normal, and it’s related to your sex and your age.

One night is not going to be sufficient to characterize your percentage in this or that sleep stage. Our patients come in saying, “I’m not getting enough REM.” But there isn’t a sleep disorder called lack of REM; there’s no treatment for that. It’s probably pretty normal for them or maybe they’re taking medications that suppress their REM, such as antidepressants.

The tech world is very interested to sense REM properly and to display it. But on the treatment side of things, there’s not much that we do with that data. We’re more interested in the consolidation of their sleep, the duration of their sleep, breathing-related sleep disorders, those sorts of things.
 

Q: Is there any reason to be concerned about the amount of REM sleep in terms of outcomes? We know that poor sleep can lead to bad cardiovascular outcomes, but has any of that correlated to sleep stage?

A:
There are studies where they’ve experimentally deprived people of certain stages of sleep, but they’re not very useful in the real world. We’re looking at sleep holistically: Do you have a good sleep pattern? Any breathing-related sleep disorders? Insomnia? We don’t treat sleep by the stage.

Q: Any concern that people who are focused on a device may be ignoring the basic tenets of good sleep hygiene?

A:
If people are doing things that are obviously bad for their sleep, like working too late, not exercising enough, sleeping in on weekends to compensate for being up late during the week, or probably the biggest thing contributing to insomnia – stress. A device itself won’t fix those things but it could show you the evidence.

If somebody really has a sleep disorder, then sleep hygiene alone is probably not going to be enough. They’re going to need to engage in a more extensive program to improve their sleep, such as cognitive-behavioral therapy for insomnia.
 

Q: Is there anything else you want to mention?

A:
I don’t want to leave with a reputation of being against sleep trackers. I think they are a great opportunity for people to get excited about and learn about their sleep and try to improve it. We have a lot to learn about what people want from their data and how we can use that data to improve people’s sleep.

As providers, we can engage with our patients – sleep is an automatic process, but improving sleep takes some effort. Buying a device is not going to automatically make you sleep better. It takes work to establish a better sleep pattern; it may require some cognitive-behavioral therapy or treating a sleep disorder. That takes some work.

Dr. Baron reported no conflicts of interest.A version of this article first appeared on Medscape.com.

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Surgery in CJD patients a potential risk factor for transmission

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About one in six patients with Creutzfeldt-Jakob disease (CJD) undergo surgery, raising the risk of iatrogenic transmission of this rare but universally fatal prion disease.

In a retrospective analysis, researchers found that 26 of 121 (21%) patients with probable or definite CJD at four U.S. academic medical centers underwent a total of 55 procedures.

These included high-risk procedures for two patients with neuropathologically proven CJD. One underwent ophthalmic artery aneurysm clipping for unruptured aneurysm, and the other underwent diagnostic brain biopsy.

“The findings were definitely surprising to me and my team – particularly the high frequency with which patients with an irreversible and particularly transmissible neurologic disease underwent invasive medical procedures either just before or shortly after the emergence of symptoms later attributed to CJD,” study investigator Gregory Day, MD, with the Mayo Clinic, Jacksonville, Fla., said in an interview.

The study was published online March 9, 2022, in JAMA Network Open.
 

Poor infection control

The investigators noted that the majority of CJD cases are sporadic or are inherited, but research shows that prion transmission can occur via contaminated tissues or reusable medical equipment.

While the risk of iatrogenic transmission is highest following procedures involving the central nervous system, where prion burden is highest, experimental models suggest CJD transmission can occur after contact with other tissues, including nasal mucosa, lung, lymph nodes, and spleen, the researchers noted.

“If these models are accurate, surgical procedures involving these tissues may pose a risk to patients,” the investigators wrote.

To determine the potential scope of this problem, the researchers examined the frequency of invasive procedures performed in patients with CJD at four tertiary care centers.

“In several cases, these procedures were done with clear indications [such as] fixation or joint replacement following a fracture. In several others, however, the procedures were unlikely to help the patient. For instance, a hip replacement for walking difficulties that were actually due to changes in the brain due to CJD,” Dr. Day said.

“Even more surprising was the low frequency with which appropriate surgical precautions/infection control procedures were used in patients with established diagnoses of CJD,” he noted.

Only one procedure was performed with sterilization techniques adequate to prevent CJD.

Dr. Day said the findings aren’t necessarily cause for immediate alarm, but they do highlight an area for potential improvement, including better screening of patients who have new and unexplained symptoms before proceeding with surgery, especially surgery of the central nervous system, where prion burden is high.

Another potential solution is to develop and support program surveillance and to work with public health organizations such the Centers for Disease Control and Prevention and the National Prion Disease Pathology Surveillance Center to elicit a surgical history in patients diagnosed with prion disease.

“Active nationwide surveillance is needed to determine the true scope of this potential problem and to develop strategies to mitigate the potential risk of iatrogenic prion transmission to future patients,” Dr. Day said.
 

True prevalence unknown

The authors of an invited commentary noted that, while most CJD infections occur sporadically, iatrogenic transmission is possible. Approximately 500 such cases have been reported worldwide to date.

“Yet, reported transmission from surgical procedures remains rare, with fewer than 10 confirmed CJD cases described in the literature, although the true prevalence is difficult to quantify as confirmed diagnosis requires autopsy,” wrote Beatrice Sun, MD, and Joseph Forrester, MD, with the department of surgery, Stanford (Calif.) University.

They noted that, over a 15-year period, 19 suspected iatrogenic CJD exposures were reported to the CDC – two from ophthalmology procedures, and 17 from neurosurgical procedures.

In all 19 cases, the diagnosis of CJD was unknown before the intervention, and all surgical instruments underwent normal decontamination protocols, which are inadequate to eradicate prion disease.

For patients with suspected or confirmed CJD, the World Health Organization has published infection control guidelines to prevent transmission of spongiform encephalopathies.

The guidelines recommend proper communication with all staff involved in the surgical procedure and the sterilization of supplies to be aware of potential exposure; minimizing the number of staff in the operating room; using single-use equipment whenever possible and disposing of it by incineration; using protective coverings for all nondisposable equipment; and scheduling such procedures at the end of the day to allow adequate time for decontamination.

Funding for the study was provided by the National Institutes of Health. Dr. Day owns stock in ANI Pharmaceuticals; serves as a consultant for Parabon Nanolabs, as a topic editor (dementia) for DynaMed, and as the clinical director of the Anti-NMDA Receptor Encephalitis Foundation (uncompensated). Dr. Forrester reported receiving unrestricted research funding from Varian and has received grant funding from the Surgical Infections Society.

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

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About one in six patients with Creutzfeldt-Jakob disease (CJD) undergo surgery, raising the risk of iatrogenic transmission of this rare but universally fatal prion disease.

In a retrospective analysis, researchers found that 26 of 121 (21%) patients with probable or definite CJD at four U.S. academic medical centers underwent a total of 55 procedures.

These included high-risk procedures for two patients with neuropathologically proven CJD. One underwent ophthalmic artery aneurysm clipping for unruptured aneurysm, and the other underwent diagnostic brain biopsy.

“The findings were definitely surprising to me and my team – particularly the high frequency with which patients with an irreversible and particularly transmissible neurologic disease underwent invasive medical procedures either just before or shortly after the emergence of symptoms later attributed to CJD,” study investigator Gregory Day, MD, with the Mayo Clinic, Jacksonville, Fla., said in an interview.

The study was published online March 9, 2022, in JAMA Network Open.
 

Poor infection control

The investigators noted that the majority of CJD cases are sporadic or are inherited, but research shows that prion transmission can occur via contaminated tissues or reusable medical equipment.

While the risk of iatrogenic transmission is highest following procedures involving the central nervous system, where prion burden is highest, experimental models suggest CJD transmission can occur after contact with other tissues, including nasal mucosa, lung, lymph nodes, and spleen, the researchers noted.

“If these models are accurate, surgical procedures involving these tissues may pose a risk to patients,” the investigators wrote.

To determine the potential scope of this problem, the researchers examined the frequency of invasive procedures performed in patients with CJD at four tertiary care centers.

“In several cases, these procedures were done with clear indications [such as] fixation or joint replacement following a fracture. In several others, however, the procedures were unlikely to help the patient. For instance, a hip replacement for walking difficulties that were actually due to changes in the brain due to CJD,” Dr. Day said.

“Even more surprising was the low frequency with which appropriate surgical precautions/infection control procedures were used in patients with established diagnoses of CJD,” he noted.

Only one procedure was performed with sterilization techniques adequate to prevent CJD.

Dr. Day said the findings aren’t necessarily cause for immediate alarm, but they do highlight an area for potential improvement, including better screening of patients who have new and unexplained symptoms before proceeding with surgery, especially surgery of the central nervous system, where prion burden is high.

Another potential solution is to develop and support program surveillance and to work with public health organizations such the Centers for Disease Control and Prevention and the National Prion Disease Pathology Surveillance Center to elicit a surgical history in patients diagnosed with prion disease.

“Active nationwide surveillance is needed to determine the true scope of this potential problem and to develop strategies to mitigate the potential risk of iatrogenic prion transmission to future patients,” Dr. Day said.
 

True prevalence unknown

The authors of an invited commentary noted that, while most CJD infections occur sporadically, iatrogenic transmission is possible. Approximately 500 such cases have been reported worldwide to date.

“Yet, reported transmission from surgical procedures remains rare, with fewer than 10 confirmed CJD cases described in the literature, although the true prevalence is difficult to quantify as confirmed diagnosis requires autopsy,” wrote Beatrice Sun, MD, and Joseph Forrester, MD, with the department of surgery, Stanford (Calif.) University.

They noted that, over a 15-year period, 19 suspected iatrogenic CJD exposures were reported to the CDC – two from ophthalmology procedures, and 17 from neurosurgical procedures.

In all 19 cases, the diagnosis of CJD was unknown before the intervention, and all surgical instruments underwent normal decontamination protocols, which are inadequate to eradicate prion disease.

For patients with suspected or confirmed CJD, the World Health Organization has published infection control guidelines to prevent transmission of spongiform encephalopathies.

The guidelines recommend proper communication with all staff involved in the surgical procedure and the sterilization of supplies to be aware of potential exposure; minimizing the number of staff in the operating room; using single-use equipment whenever possible and disposing of it by incineration; using protective coverings for all nondisposable equipment; and scheduling such procedures at the end of the day to allow adequate time for decontamination.

Funding for the study was provided by the National Institutes of Health. Dr. Day owns stock in ANI Pharmaceuticals; serves as a consultant for Parabon Nanolabs, as a topic editor (dementia) for DynaMed, and as the clinical director of the Anti-NMDA Receptor Encephalitis Foundation (uncompensated). Dr. Forrester reported receiving unrestricted research funding from Varian and has received grant funding from the Surgical Infections Society.

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

About one in six patients with Creutzfeldt-Jakob disease (CJD) undergo surgery, raising the risk of iatrogenic transmission of this rare but universally fatal prion disease.

In a retrospective analysis, researchers found that 26 of 121 (21%) patients with probable or definite CJD at four U.S. academic medical centers underwent a total of 55 procedures.

These included high-risk procedures for two patients with neuropathologically proven CJD. One underwent ophthalmic artery aneurysm clipping for unruptured aneurysm, and the other underwent diagnostic brain biopsy.

“The findings were definitely surprising to me and my team – particularly the high frequency with which patients with an irreversible and particularly transmissible neurologic disease underwent invasive medical procedures either just before or shortly after the emergence of symptoms later attributed to CJD,” study investigator Gregory Day, MD, with the Mayo Clinic, Jacksonville, Fla., said in an interview.

The study was published online March 9, 2022, in JAMA Network Open.
 

Poor infection control

The investigators noted that the majority of CJD cases are sporadic or are inherited, but research shows that prion transmission can occur via contaminated tissues or reusable medical equipment.

While the risk of iatrogenic transmission is highest following procedures involving the central nervous system, where prion burden is highest, experimental models suggest CJD transmission can occur after contact with other tissues, including nasal mucosa, lung, lymph nodes, and spleen, the researchers noted.

“If these models are accurate, surgical procedures involving these tissues may pose a risk to patients,” the investigators wrote.

To determine the potential scope of this problem, the researchers examined the frequency of invasive procedures performed in patients with CJD at four tertiary care centers.

“In several cases, these procedures were done with clear indications [such as] fixation or joint replacement following a fracture. In several others, however, the procedures were unlikely to help the patient. For instance, a hip replacement for walking difficulties that were actually due to changes in the brain due to CJD,” Dr. Day said.

“Even more surprising was the low frequency with which appropriate surgical precautions/infection control procedures were used in patients with established diagnoses of CJD,” he noted.

Only one procedure was performed with sterilization techniques adequate to prevent CJD.

Dr. Day said the findings aren’t necessarily cause for immediate alarm, but they do highlight an area for potential improvement, including better screening of patients who have new and unexplained symptoms before proceeding with surgery, especially surgery of the central nervous system, where prion burden is high.

Another potential solution is to develop and support program surveillance and to work with public health organizations such the Centers for Disease Control and Prevention and the National Prion Disease Pathology Surveillance Center to elicit a surgical history in patients diagnosed with prion disease.

“Active nationwide surveillance is needed to determine the true scope of this potential problem and to develop strategies to mitigate the potential risk of iatrogenic prion transmission to future patients,” Dr. Day said.
 

True prevalence unknown

The authors of an invited commentary noted that, while most CJD infections occur sporadically, iatrogenic transmission is possible. Approximately 500 such cases have been reported worldwide to date.

“Yet, reported transmission from surgical procedures remains rare, with fewer than 10 confirmed CJD cases described in the literature, although the true prevalence is difficult to quantify as confirmed diagnosis requires autopsy,” wrote Beatrice Sun, MD, and Joseph Forrester, MD, with the department of surgery, Stanford (Calif.) University.

They noted that, over a 15-year period, 19 suspected iatrogenic CJD exposures were reported to the CDC – two from ophthalmology procedures, and 17 from neurosurgical procedures.

In all 19 cases, the diagnosis of CJD was unknown before the intervention, and all surgical instruments underwent normal decontamination protocols, which are inadequate to eradicate prion disease.

For patients with suspected or confirmed CJD, the World Health Organization has published infection control guidelines to prevent transmission of spongiform encephalopathies.

The guidelines recommend proper communication with all staff involved in the surgical procedure and the sterilization of supplies to be aware of potential exposure; minimizing the number of staff in the operating room; using single-use equipment whenever possible and disposing of it by incineration; using protective coverings for all nondisposable equipment; and scheduling such procedures at the end of the day to allow adequate time for decontamination.

Funding for the study was provided by the National Institutes of Health. Dr. Day owns stock in ANI Pharmaceuticals; serves as a consultant for Parabon Nanolabs, as a topic editor (dementia) for DynaMed, and as the clinical director of the Anti-NMDA Receptor Encephalitis Foundation (uncompensated). Dr. Forrester reported receiving unrestricted research funding from Varian and has received grant funding from the Surgical Infections Society.

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

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As FDA OKs another COVID booster, some experts question need

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The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

 

 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

 

 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

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The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

 

 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

 

 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

 

 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

 

 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

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Going digital won’t fully fix prior authorizations, say medical groups

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Before working to create standards for electronic prior authorization, the entire process itself needs some work.

That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”

According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.

In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”

AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.

Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.

Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
 

AHA: Most common prior auth means are phones, fax

The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”

The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.

To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.

In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.

The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.

Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.

In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”

The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”

The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”

In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”

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

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Before working to create standards for electronic prior authorization, the entire process itself needs some work.

That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”

According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.

In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”

AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.

Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.

Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
 

AHA: Most common prior auth means are phones, fax

The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”

The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.

To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.

In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.

The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.

Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.

In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”

The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”

The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”

In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”

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

Before working to create standards for electronic prior authorization, the entire process itself needs some work.

That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”

According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.

In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”

AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.

Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.

Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
 

AHA: Most common prior auth means are phones, fax

The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”

The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.

To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.

In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.

The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.

Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.

In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”

The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”

The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”

In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”

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

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Courtesy: It’s not so common anymore

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Earlier this month one of our dogs needed surgery. Early one morning I dropped her off at the veterinarian’s office.

About 10 minutes after leaving, they called and asked me to come back and get her. The vet had called in sick, so all her surgeries for the day had to be rescheduled.

Dr. Allan M. Block

It’s a pain in the rear, but what can you do? It happens to the best of us. My staff has had their share of times where they had to frantically call and reschedule patients when I was too sick to work.

So I drove back and waited in line. Most people were understanding, but some less so. The lady in front of me was demanding her dog’s surgery (which hadn’t happened yet) be free due to her being inconvenienced. A staff member at another desk was dealing with an angry man who was demanding the veterinarian’s home phone number.

When I got up to the front I picked up my dog and rescheduled the surgery for 2 weeks later. The young lady at the desk handed me a reminder card and said “Thank you for not yelling at me.”

How sad is that? Is this what our society has come to, where people feel obliged to thank you for not being an ass?

Common courtesy should be the rule rather than the exception, right? What’s wrong with politeness?

Yeah, going back to have to get my dog and reschedule her surgery is an inconvenience, but that’s about it. Certainly not something to get worked up over, or to scream at another person who’s just doing their job. Getting sick is part of life. It’s happened to me, it’s happened to you, and on this day it happened to our veterinarian.

Our supposedly polite society seems to have gone in reverse during the pandemic, though the change had probably started before then. Although we all went through it together, for some it’s removed the thin veneer of civilization, leaving them angry, bitter, and hostile over things that are beyond the control of mortals.

Whatever happened to the Golden Rule? It takes less effort to be nice than nasty, and it’s definitely better for your blood pressure.

I really don’t understand this. What’s to be gained by going through the world angry at things you can’t control? Especially when they’re so minor, like having to reschedule a veterinarian’s appointment.

It just ain’t worth it to be like that. For you, or the innocent person you’re abusing.

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

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Earlier this month one of our dogs needed surgery. Early one morning I dropped her off at the veterinarian’s office.

About 10 minutes after leaving, they called and asked me to come back and get her. The vet had called in sick, so all her surgeries for the day had to be rescheduled.

Dr. Allan M. Block

It’s a pain in the rear, but what can you do? It happens to the best of us. My staff has had their share of times where they had to frantically call and reschedule patients when I was too sick to work.

So I drove back and waited in line. Most people were understanding, but some less so. The lady in front of me was demanding her dog’s surgery (which hadn’t happened yet) be free due to her being inconvenienced. A staff member at another desk was dealing with an angry man who was demanding the veterinarian’s home phone number.

When I got up to the front I picked up my dog and rescheduled the surgery for 2 weeks later. The young lady at the desk handed me a reminder card and said “Thank you for not yelling at me.”

How sad is that? Is this what our society has come to, where people feel obliged to thank you for not being an ass?

Common courtesy should be the rule rather than the exception, right? What’s wrong with politeness?

Yeah, going back to have to get my dog and reschedule her surgery is an inconvenience, but that’s about it. Certainly not something to get worked up over, or to scream at another person who’s just doing their job. Getting sick is part of life. It’s happened to me, it’s happened to you, and on this day it happened to our veterinarian.

Our supposedly polite society seems to have gone in reverse during the pandemic, though the change had probably started before then. Although we all went through it together, for some it’s removed the thin veneer of civilization, leaving them angry, bitter, and hostile over things that are beyond the control of mortals.

Whatever happened to the Golden Rule? It takes less effort to be nice than nasty, and it’s definitely better for your blood pressure.

I really don’t understand this. What’s to be gained by going through the world angry at things you can’t control? Especially when they’re so minor, like having to reschedule a veterinarian’s appointment.

It just ain’t worth it to be like that. For you, or the innocent person you’re abusing.

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

Earlier this month one of our dogs needed surgery. Early one morning I dropped her off at the veterinarian’s office.

About 10 minutes after leaving, they called and asked me to come back and get her. The vet had called in sick, so all her surgeries for the day had to be rescheduled.

Dr. Allan M. Block

It’s a pain in the rear, but what can you do? It happens to the best of us. My staff has had their share of times where they had to frantically call and reschedule patients when I was too sick to work.

So I drove back and waited in line. Most people were understanding, but some less so. The lady in front of me was demanding her dog’s surgery (which hadn’t happened yet) be free due to her being inconvenienced. A staff member at another desk was dealing with an angry man who was demanding the veterinarian’s home phone number.

When I got up to the front I picked up my dog and rescheduled the surgery for 2 weeks later. The young lady at the desk handed me a reminder card and said “Thank you for not yelling at me.”

How sad is that? Is this what our society has come to, where people feel obliged to thank you for not being an ass?

Common courtesy should be the rule rather than the exception, right? What’s wrong with politeness?

Yeah, going back to have to get my dog and reschedule her surgery is an inconvenience, but that’s about it. Certainly not something to get worked up over, or to scream at another person who’s just doing their job. Getting sick is part of life. It’s happened to me, it’s happened to you, and on this day it happened to our veterinarian.

Our supposedly polite society seems to have gone in reverse during the pandemic, though the change had probably started before then. Although we all went through it together, for some it’s removed the thin veneer of civilization, leaving them angry, bitter, and hostile over things that are beyond the control of mortals.

Whatever happened to the Golden Rule? It takes less effort to be nice than nasty, and it’s definitely better for your blood pressure.

I really don’t understand this. What’s to be gained by going through the world angry at things you can’t control? Especially when they’re so minor, like having to reschedule a veterinarian’s appointment.

It just ain’t worth it to be like that. For you, or the innocent person you’re abusing.

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

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Different variants may cause different long COVID symptoms: Study

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Long COVID symptoms may differ depending on which SARS-CoV-2 variant is behind a person’s infection, a new study shows.

The data from Italy compared long COVID symptoms reported by patients infected with SARS-CoV-2 from March to December 2020 (when the original, or “Wuhan,” variant was dominant) with those reported by patients infected from January to April 2021 (B.1.1.7-, or Alpha variant-dominant). It showed a substantial change in the pattern of neurological and cognitive/emotional problems – the latter mostly seen with the Alpha variant.

Infectious disease specialist Michele Spinicci, MD, from the University of Florence and Careggi University Hospital, Italy, led the work. “Many of the symptoms reported in this study have been measured [before], but this is the first time they have been linked to different COVID-19 variants,” he told this news organization. “Findings in patients with long COVID were focused on neurological and psychological difficulties.”

However, he pointed out that much remains to be understood about long COVID in terms of symptoms, diagnosis, and treatment. 

“Long COVID is a huge area that involves many different fields of medicine, so there is not one single piece of advice to give on management. There’s lots to consider when evaluating a long COVID patient,” he said.

Results showed that when the Alpha variant was the dominant variant, the prevalence of myalgia (10%), dyspnea (42%), brain fog/mental confusion (17%), and anxiety/depression (13%) significantly increased relative to the wild-type (original, Wuhan) variant, while anosmia (2%), dysgeusia (4%), and impaired hearing (1%) were less common.

When the wild-type (original, Wuhan) variant was dominant, fatigue (37%), insomnia (16%), dysgeusia (11%), and impaired hearing (5%) were all more common than with the Alpha variant. Dyspnea (33%), brain fog (10%), myalgia (4%), and anxiety/depression (6%) were less common. 

Overall, 76% of the patients in the trial reported at least one persistent symptom, while the most common reported symptoms were dyspnea (37%) and chronic fatigue (36%), followed by insomnia (16%), visual disorders (13%), and brain fog (13%).

The findings come from an early-release abstract that will be presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022, in Lisbon, Portugal, in a few weeks’ time.
 

‘The take-home point’  

Michael A. Horberg, MD, associate medical director, Kaiser Permanente – Mid-Atlantic Permanente Medical Group, Rockville, Maryland, has recently presented data on symptoms seen with long COVID in over 28,000 people, as reported by this news organization, at the Conference on Retroviruses and Opportunistic Infections 2022. These people were infected with the wild-type virus.

Commenting on the study by Dr. Spinicci, he said: “The issue is that as we go along the COVID lifespan from acute to long COVID, what prompts patients to seek medical attention may change. If symptoms are not severe or were not well publicized previously, patients may not see the need to seek care or evaluation. As such, it doesn’t surprise me to find these changes over time, independent of any potential biological activity of the virus or its consequences.”

Dr. Horberg noted that their own study results are consistent with those of Dr. Spinicci et al. from March to December 2020 (original, Wuhan variant). “To me, the take-home point is long COVID is real, and physicians need to be on the lookout for it. However, not all symptoms are due to long COVID, and we need to keep the time course of symptoms during evaluation of such patients.”

Also providing comment on the findings was Debby Bogaert, MD, chair of Pediatric Medicine, University of Edinburgh. Reflecting on whether the symptoms were due to long COVID or another underlying disease, she said: “The number of patients with ongoing symptoms is very high, therefore [it is] unlikely that all of this is re-emergence of underlying or previous health problems. The type of symptoms reported are also as reported by other cohorts, so not unexpected. And irrespective of the root cause, they require care.”

Dr. Bogaert also noted that the data reiterate that COVID-19 is a new disease, and that “new variants might show shifting clinical pictures, not only regarding severity and symptoms of acute disease, but possibly also regarding sequela,” and that this, “underlines the importance of ongoing surveillance of variants, and ongoing evaluation of the acute and long-term clinical picture accompanying these, to ensure we adapt our public health approaches, clinical treatment plans, and long-term follow-up when and where needed.”

Dr. Bogaert stressed that only by keeping track of the changes in symptoms both acute and long-term – by patients and doctors – would the best patient care be provided.

“Patients need to know so they can report these back to their doctors, and doctors need to know over time that the picture of sequela might shift, so sequela are recognized early, and these patients receive the appropriate follow-up treatment,” she said. These shifting patterns might also apply to community patients as well as those hospitalized with COVID-19.
 

 

 

Study details

The retrospective, observational study included 428 patients, 59% men, with a mean age of 64 years, who had been treated at the Careggi University Hospital’s post-COVID outpatient service between June 2020 and June 2021, when the original form of SARS-CoV-2, and later the Alpha variant, were circulating, with some overlap.

All patients had been hospitalized with COVID-19 and discharged 4-12 weeks prior to attending the outpatient post-COVID service. They were asked to complete a questionnaire on persistent symptoms at the median of 53 days after being discharged from the hospital. In addition, data on medical history, microbiological and clinical COVID-19 course, self-reported symptoms (at the point of the follow-up visit), and patient demographics were obtained from electronic medical records.
 

Newer variants being studied

Upon analysis of long COVID symptoms according to treatment given during the acute phase using multivariate analysis, increasing oxygen support (odds ratio, 1.4; 95% confidence interval, 1.1-1.8), use of immunosuppressant drugs (OR, 6.4; 95% CI, 1.5-28), and female sex (OR, 1.8; 95% CI, 1.1-2.9) were associated with a higher risk for long COVID symptoms, while patients with type 2 diabetes (OR, 0.4; 95% CI, 0.2-0.7) had a lower risk of developing long COVID symptoms.

When asked whether the increased anxiety and depression seen with the Alpha variant might be also linked to the fact that people are living through hard times, with lockdowns, economic difficulties, possible illness, and even fatalities among family and friends due to COVID, Dr. Spinicci pointed out that “it’s a preliminary study, and there are lots of factors that we didn’t explore. It’s difficult to arrive at definite conclusions about long COVID because so much remains unknown. There are lots of external and environmental factors in the general population that might contribute to these findings.”

Dr. Spinicci has continued to enroll patients from later periods of the pandemic, including patients who were infected with the Delta and Omicron variants of SARS-CoV-2.

“We’re interested in finding out if these other variants are also associated with different phenotypes of long COVID. This study is part of our follow-up program here in the hospital where lots of different specialties are following patients for 20 months,” he said.

Dr. Horberg noted that one criticism of this study is that it was unclear whether the researchers accounted for pre-existing conditions. “They note the co-morbidities in the table 1, but don’t say how they accounted for that in their analyses. We found a lot of what patients were calling ‘long COVID’ were exacerbations of co-morbidities but not a new condition.” 

Dr. Spinicci and his coauthors acknowledged that the study was observational. And, as such, it does not prove cause and effect, and they could not confirm which variant of the virus caused the infection in different patients, which may limit the conclusions that can be drawn.

“Future research should focus on the potential impacts of variants of concern and vaccination status on ongoing symptoms,” Spinicci said.

Early release of an abstract will be presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022, in Lisbon, Portugal, April 23-26, 2022. Abstract 02768.

Dr. Spinicci and Dr. Horberg have disclosed no relevant financial relationships. Dr. Bogaert declared that she is on the program committee of ECCMID; she has been a member of SIGN/NICE COVID-19 rapid guideline: managing the long-term effects of COVID-19; and she is involved in multiple ongoing COVID-related studies, both acute and long-term sequela (funding MRC, CSO, ZonMw).

 

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

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Long COVID symptoms may differ depending on which SARS-CoV-2 variant is behind a person’s infection, a new study shows.

The data from Italy compared long COVID symptoms reported by patients infected with SARS-CoV-2 from March to December 2020 (when the original, or “Wuhan,” variant was dominant) with those reported by patients infected from January to April 2021 (B.1.1.7-, or Alpha variant-dominant). It showed a substantial change in the pattern of neurological and cognitive/emotional problems – the latter mostly seen with the Alpha variant.

Infectious disease specialist Michele Spinicci, MD, from the University of Florence and Careggi University Hospital, Italy, led the work. “Many of the symptoms reported in this study have been measured [before], but this is the first time they have been linked to different COVID-19 variants,” he told this news organization. “Findings in patients with long COVID were focused on neurological and psychological difficulties.”

However, he pointed out that much remains to be understood about long COVID in terms of symptoms, diagnosis, and treatment. 

“Long COVID is a huge area that involves many different fields of medicine, so there is not one single piece of advice to give on management. There’s lots to consider when evaluating a long COVID patient,” he said.

Results showed that when the Alpha variant was the dominant variant, the prevalence of myalgia (10%), dyspnea (42%), brain fog/mental confusion (17%), and anxiety/depression (13%) significantly increased relative to the wild-type (original, Wuhan) variant, while anosmia (2%), dysgeusia (4%), and impaired hearing (1%) were less common.

When the wild-type (original, Wuhan) variant was dominant, fatigue (37%), insomnia (16%), dysgeusia (11%), and impaired hearing (5%) were all more common than with the Alpha variant. Dyspnea (33%), brain fog (10%), myalgia (4%), and anxiety/depression (6%) were less common. 

Overall, 76% of the patients in the trial reported at least one persistent symptom, while the most common reported symptoms were dyspnea (37%) and chronic fatigue (36%), followed by insomnia (16%), visual disorders (13%), and brain fog (13%).

The findings come from an early-release abstract that will be presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022, in Lisbon, Portugal, in a few weeks’ time.
 

‘The take-home point’  

Michael A. Horberg, MD, associate medical director, Kaiser Permanente – Mid-Atlantic Permanente Medical Group, Rockville, Maryland, has recently presented data on symptoms seen with long COVID in over 28,000 people, as reported by this news organization, at the Conference on Retroviruses and Opportunistic Infections 2022. These people were infected with the wild-type virus.

Commenting on the study by Dr. Spinicci, he said: “The issue is that as we go along the COVID lifespan from acute to long COVID, what prompts patients to seek medical attention may change. If symptoms are not severe or were not well publicized previously, patients may not see the need to seek care or evaluation. As such, it doesn’t surprise me to find these changes over time, independent of any potential biological activity of the virus or its consequences.”

Dr. Horberg noted that their own study results are consistent with those of Dr. Spinicci et al. from March to December 2020 (original, Wuhan variant). “To me, the take-home point is long COVID is real, and physicians need to be on the lookout for it. However, not all symptoms are due to long COVID, and we need to keep the time course of symptoms during evaluation of such patients.”

Also providing comment on the findings was Debby Bogaert, MD, chair of Pediatric Medicine, University of Edinburgh. Reflecting on whether the symptoms were due to long COVID or another underlying disease, she said: “The number of patients with ongoing symptoms is very high, therefore [it is] unlikely that all of this is re-emergence of underlying or previous health problems. The type of symptoms reported are also as reported by other cohorts, so not unexpected. And irrespective of the root cause, they require care.”

Dr. Bogaert also noted that the data reiterate that COVID-19 is a new disease, and that “new variants might show shifting clinical pictures, not only regarding severity and symptoms of acute disease, but possibly also regarding sequela,” and that this, “underlines the importance of ongoing surveillance of variants, and ongoing evaluation of the acute and long-term clinical picture accompanying these, to ensure we adapt our public health approaches, clinical treatment plans, and long-term follow-up when and where needed.”

Dr. Bogaert stressed that only by keeping track of the changes in symptoms both acute and long-term – by patients and doctors – would the best patient care be provided.

“Patients need to know so they can report these back to their doctors, and doctors need to know over time that the picture of sequela might shift, so sequela are recognized early, and these patients receive the appropriate follow-up treatment,” she said. These shifting patterns might also apply to community patients as well as those hospitalized with COVID-19.
 

 

 

Study details

The retrospective, observational study included 428 patients, 59% men, with a mean age of 64 years, who had been treated at the Careggi University Hospital’s post-COVID outpatient service between June 2020 and June 2021, when the original form of SARS-CoV-2, and later the Alpha variant, were circulating, with some overlap.

All patients had been hospitalized with COVID-19 and discharged 4-12 weeks prior to attending the outpatient post-COVID service. They were asked to complete a questionnaire on persistent symptoms at the median of 53 days after being discharged from the hospital. In addition, data on medical history, microbiological and clinical COVID-19 course, self-reported symptoms (at the point of the follow-up visit), and patient demographics were obtained from electronic medical records.
 

Newer variants being studied

Upon analysis of long COVID symptoms according to treatment given during the acute phase using multivariate analysis, increasing oxygen support (odds ratio, 1.4; 95% confidence interval, 1.1-1.8), use of immunosuppressant drugs (OR, 6.4; 95% CI, 1.5-28), and female sex (OR, 1.8; 95% CI, 1.1-2.9) were associated with a higher risk for long COVID symptoms, while patients with type 2 diabetes (OR, 0.4; 95% CI, 0.2-0.7) had a lower risk of developing long COVID symptoms.

When asked whether the increased anxiety and depression seen with the Alpha variant might be also linked to the fact that people are living through hard times, with lockdowns, economic difficulties, possible illness, and even fatalities among family and friends due to COVID, Dr. Spinicci pointed out that “it’s a preliminary study, and there are lots of factors that we didn’t explore. It’s difficult to arrive at definite conclusions about long COVID because so much remains unknown. There are lots of external and environmental factors in the general population that might contribute to these findings.”

Dr. Spinicci has continued to enroll patients from later periods of the pandemic, including patients who were infected with the Delta and Omicron variants of SARS-CoV-2.

“We’re interested in finding out if these other variants are also associated with different phenotypes of long COVID. This study is part of our follow-up program here in the hospital where lots of different specialties are following patients for 20 months,” he said.

Dr. Horberg noted that one criticism of this study is that it was unclear whether the researchers accounted for pre-existing conditions. “They note the co-morbidities in the table 1, but don’t say how they accounted for that in their analyses. We found a lot of what patients were calling ‘long COVID’ were exacerbations of co-morbidities but not a new condition.” 

Dr. Spinicci and his coauthors acknowledged that the study was observational. And, as such, it does not prove cause and effect, and they could not confirm which variant of the virus caused the infection in different patients, which may limit the conclusions that can be drawn.

“Future research should focus on the potential impacts of variants of concern and vaccination status on ongoing symptoms,” Spinicci said.

Early release of an abstract will be presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022, in Lisbon, Portugal, April 23-26, 2022. Abstract 02768.

Dr. Spinicci and Dr. Horberg have disclosed no relevant financial relationships. Dr. Bogaert declared that she is on the program committee of ECCMID; she has been a member of SIGN/NICE COVID-19 rapid guideline: managing the long-term effects of COVID-19; and she is involved in multiple ongoing COVID-related studies, both acute and long-term sequela (funding MRC, CSO, ZonMw).

 

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

Long COVID symptoms may differ depending on which SARS-CoV-2 variant is behind a person’s infection, a new study shows.

The data from Italy compared long COVID symptoms reported by patients infected with SARS-CoV-2 from March to December 2020 (when the original, or “Wuhan,” variant was dominant) with those reported by patients infected from January to April 2021 (B.1.1.7-, or Alpha variant-dominant). It showed a substantial change in the pattern of neurological and cognitive/emotional problems – the latter mostly seen with the Alpha variant.

Infectious disease specialist Michele Spinicci, MD, from the University of Florence and Careggi University Hospital, Italy, led the work. “Many of the symptoms reported in this study have been measured [before], but this is the first time they have been linked to different COVID-19 variants,” he told this news organization. “Findings in patients with long COVID were focused on neurological and psychological difficulties.”

However, he pointed out that much remains to be understood about long COVID in terms of symptoms, diagnosis, and treatment. 

“Long COVID is a huge area that involves many different fields of medicine, so there is not one single piece of advice to give on management. There’s lots to consider when evaluating a long COVID patient,” he said.

Results showed that when the Alpha variant was the dominant variant, the prevalence of myalgia (10%), dyspnea (42%), brain fog/mental confusion (17%), and anxiety/depression (13%) significantly increased relative to the wild-type (original, Wuhan) variant, while anosmia (2%), dysgeusia (4%), and impaired hearing (1%) were less common.

When the wild-type (original, Wuhan) variant was dominant, fatigue (37%), insomnia (16%), dysgeusia (11%), and impaired hearing (5%) were all more common than with the Alpha variant. Dyspnea (33%), brain fog (10%), myalgia (4%), and anxiety/depression (6%) were less common. 

Overall, 76% of the patients in the trial reported at least one persistent symptom, while the most common reported symptoms were dyspnea (37%) and chronic fatigue (36%), followed by insomnia (16%), visual disorders (13%), and brain fog (13%).

The findings come from an early-release abstract that will be presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022, in Lisbon, Portugal, in a few weeks’ time.
 

‘The take-home point’  

Michael A. Horberg, MD, associate medical director, Kaiser Permanente – Mid-Atlantic Permanente Medical Group, Rockville, Maryland, has recently presented data on symptoms seen with long COVID in over 28,000 people, as reported by this news organization, at the Conference on Retroviruses and Opportunistic Infections 2022. These people were infected with the wild-type virus.

Commenting on the study by Dr. Spinicci, he said: “The issue is that as we go along the COVID lifespan from acute to long COVID, what prompts patients to seek medical attention may change. If symptoms are not severe or were not well publicized previously, patients may not see the need to seek care or evaluation. As such, it doesn’t surprise me to find these changes over time, independent of any potential biological activity of the virus or its consequences.”

Dr. Horberg noted that their own study results are consistent with those of Dr. Spinicci et al. from March to December 2020 (original, Wuhan variant). “To me, the take-home point is long COVID is real, and physicians need to be on the lookout for it. However, not all symptoms are due to long COVID, and we need to keep the time course of symptoms during evaluation of such patients.”

Also providing comment on the findings was Debby Bogaert, MD, chair of Pediatric Medicine, University of Edinburgh. Reflecting on whether the symptoms were due to long COVID or another underlying disease, she said: “The number of patients with ongoing symptoms is very high, therefore [it is] unlikely that all of this is re-emergence of underlying or previous health problems. The type of symptoms reported are also as reported by other cohorts, so not unexpected. And irrespective of the root cause, they require care.”

Dr. Bogaert also noted that the data reiterate that COVID-19 is a new disease, and that “new variants might show shifting clinical pictures, not only regarding severity and symptoms of acute disease, but possibly also regarding sequela,” and that this, “underlines the importance of ongoing surveillance of variants, and ongoing evaluation of the acute and long-term clinical picture accompanying these, to ensure we adapt our public health approaches, clinical treatment plans, and long-term follow-up when and where needed.”

Dr. Bogaert stressed that only by keeping track of the changes in symptoms both acute and long-term – by patients and doctors – would the best patient care be provided.

“Patients need to know so they can report these back to their doctors, and doctors need to know over time that the picture of sequela might shift, so sequela are recognized early, and these patients receive the appropriate follow-up treatment,” she said. These shifting patterns might also apply to community patients as well as those hospitalized with COVID-19.
 

 

 

Study details

The retrospective, observational study included 428 patients, 59% men, with a mean age of 64 years, who had been treated at the Careggi University Hospital’s post-COVID outpatient service between June 2020 and June 2021, when the original form of SARS-CoV-2, and later the Alpha variant, were circulating, with some overlap.

All patients had been hospitalized with COVID-19 and discharged 4-12 weeks prior to attending the outpatient post-COVID service. They were asked to complete a questionnaire on persistent symptoms at the median of 53 days after being discharged from the hospital. In addition, data on medical history, microbiological and clinical COVID-19 course, self-reported symptoms (at the point of the follow-up visit), and patient demographics were obtained from electronic medical records.
 

Newer variants being studied

Upon analysis of long COVID symptoms according to treatment given during the acute phase using multivariate analysis, increasing oxygen support (odds ratio, 1.4; 95% confidence interval, 1.1-1.8), use of immunosuppressant drugs (OR, 6.4; 95% CI, 1.5-28), and female sex (OR, 1.8; 95% CI, 1.1-2.9) were associated with a higher risk for long COVID symptoms, while patients with type 2 diabetes (OR, 0.4; 95% CI, 0.2-0.7) had a lower risk of developing long COVID symptoms.

When asked whether the increased anxiety and depression seen with the Alpha variant might be also linked to the fact that people are living through hard times, with lockdowns, economic difficulties, possible illness, and even fatalities among family and friends due to COVID, Dr. Spinicci pointed out that “it’s a preliminary study, and there are lots of factors that we didn’t explore. It’s difficult to arrive at definite conclusions about long COVID because so much remains unknown. There are lots of external and environmental factors in the general population that might contribute to these findings.”

Dr. Spinicci has continued to enroll patients from later periods of the pandemic, including patients who were infected with the Delta and Omicron variants of SARS-CoV-2.

“We’re interested in finding out if these other variants are also associated with different phenotypes of long COVID. This study is part of our follow-up program here in the hospital where lots of different specialties are following patients for 20 months,” he said.

Dr. Horberg noted that one criticism of this study is that it was unclear whether the researchers accounted for pre-existing conditions. “They note the co-morbidities in the table 1, but don’t say how they accounted for that in their analyses. We found a lot of what patients were calling ‘long COVID’ were exacerbations of co-morbidities but not a new condition.” 

Dr. Spinicci and his coauthors acknowledged that the study was observational. And, as such, it does not prove cause and effect, and they could not confirm which variant of the virus caused the infection in different patients, which may limit the conclusions that can be drawn.

“Future research should focus on the potential impacts of variants of concern and vaccination status on ongoing symptoms,” Spinicci said.

Early release of an abstract will be presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022, in Lisbon, Portugal, April 23-26, 2022. Abstract 02768.

Dr. Spinicci and Dr. Horberg have disclosed no relevant financial relationships. Dr. Bogaert declared that she is on the program committee of ECCMID; she has been a member of SIGN/NICE COVID-19 rapid guideline: managing the long-term effects of COVID-19; and she is involved in multiple ongoing COVID-related studies, both acute and long-term sequela (funding MRC, CSO, ZonMw).

 

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

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Does hustling equate to success?

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Thank Goodness it’s Monday? Sincerely yours, #hustle. 

The COVID-19 pandemic has given us the opportunity to reevaluate what we believe is important and valuable in our life. For some, it’s the opportunity to perform meaningful work; for others, it’s increased financial compensation; and, for the remaining, it may be autonomy (e.g., control over their time). One example of where this mindset has manifested has been in the Great Resignation. 

The Great Resignation refers to the significant increase in resignations that was recorded in April 2021. Resignation rates tend to be higher in fields with high turnover rates (e.g., health care, tech) as a result of increased demand and burnout. Although hustle culture has been an ongoing trend for the last few years, the pandemic has given somewhat of a reality check of the future. 

Hustle culture refers to the embracing of work as a lifestyle such that it takes over other important aspects of your life – in other words, when work-life balance becomes work-work (im)balance. It has also been aptly referred to as burnout culture or grind culture. It’s a bit ironic or counterintuitive to think that stopping work means increased productivity – but it’s true. 

During my undergraduate years, I was always hustling – there wasn’t a moment where I wasn’t studying, doing research, training for my sport, or thinking about how I could do better and be better. It was all about working 24/7 – an illusion to think I was being productive. Now don’t get me wrong, I think the time and effort I invested during those years paid off. However, it also resulted in a sense of dissatisfaction; that is, dissatisfaction that I didn’t explore other potential paths, that I didn’t have the courage to try new things and to be okay with making mistakes. I had extremely narrow tunnel vision because my one and only goal was to go to medical school. 

However, after entering graduate school and actually taking the time to explore other options and career pathways in health, as well as realize that nontraditional pathways are becoming more and more conventional, there is a sense of relief that “failure” is not about changing paths or making mistakes. 

The part of hustle culture that has me hung up is being able to take the time to reflect whether this is what you truly want. I still believe in the value of hard work but I also believe in the value of meaningful and efficient work while also taking the time to reflect. 

The pandemic has shaped a lot of the way we think, what we value, and how we proceed forward. Who we are and what we value is a continuing and ever-growing process, and how we choose to live our lives will play a part. 

I’m curious to hear from you, do you believe in #hustle? Are you part of the #grind culture? Or do you believe we can achieve success, greatness, and satisfaction without the hustle culture?
 

Ms. Lui is an MSc candidate at the University of Toronto, and is with the Mood Disorders Psychopharmacology Unit, Toronto Western Hospital. She has received income from Braxia Scientific. A version of this article first appeared on Medscape.com.

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Thank Goodness it’s Monday? Sincerely yours, #hustle. 

The COVID-19 pandemic has given us the opportunity to reevaluate what we believe is important and valuable in our life. For some, it’s the opportunity to perform meaningful work; for others, it’s increased financial compensation; and, for the remaining, it may be autonomy (e.g., control over their time). One example of where this mindset has manifested has been in the Great Resignation. 

The Great Resignation refers to the significant increase in resignations that was recorded in April 2021. Resignation rates tend to be higher in fields with high turnover rates (e.g., health care, tech) as a result of increased demand and burnout. Although hustle culture has been an ongoing trend for the last few years, the pandemic has given somewhat of a reality check of the future. 

Hustle culture refers to the embracing of work as a lifestyle such that it takes over other important aspects of your life – in other words, when work-life balance becomes work-work (im)balance. It has also been aptly referred to as burnout culture or grind culture. It’s a bit ironic or counterintuitive to think that stopping work means increased productivity – but it’s true. 

During my undergraduate years, I was always hustling – there wasn’t a moment where I wasn’t studying, doing research, training for my sport, or thinking about how I could do better and be better. It was all about working 24/7 – an illusion to think I was being productive. Now don’t get me wrong, I think the time and effort I invested during those years paid off. However, it also resulted in a sense of dissatisfaction; that is, dissatisfaction that I didn’t explore other potential paths, that I didn’t have the courage to try new things and to be okay with making mistakes. I had extremely narrow tunnel vision because my one and only goal was to go to medical school. 

However, after entering graduate school and actually taking the time to explore other options and career pathways in health, as well as realize that nontraditional pathways are becoming more and more conventional, there is a sense of relief that “failure” is not about changing paths or making mistakes. 

The part of hustle culture that has me hung up is being able to take the time to reflect whether this is what you truly want. I still believe in the value of hard work but I also believe in the value of meaningful and efficient work while also taking the time to reflect. 

The pandemic has shaped a lot of the way we think, what we value, and how we proceed forward. Who we are and what we value is a continuing and ever-growing process, and how we choose to live our lives will play a part. 

I’m curious to hear from you, do you believe in #hustle? Are you part of the #grind culture? Or do you believe we can achieve success, greatness, and satisfaction without the hustle culture?
 

Ms. Lui is an MSc candidate at the University of Toronto, and is with the Mood Disorders Psychopharmacology Unit, Toronto Western Hospital. She has received income from Braxia Scientific. A version of this article first appeared on Medscape.com.

Thank Goodness it’s Monday? Sincerely yours, #hustle. 

The COVID-19 pandemic has given us the opportunity to reevaluate what we believe is important and valuable in our life. For some, it’s the opportunity to perform meaningful work; for others, it’s increased financial compensation; and, for the remaining, it may be autonomy (e.g., control over their time). One example of where this mindset has manifested has been in the Great Resignation. 

The Great Resignation refers to the significant increase in resignations that was recorded in April 2021. Resignation rates tend to be higher in fields with high turnover rates (e.g., health care, tech) as a result of increased demand and burnout. Although hustle culture has been an ongoing trend for the last few years, the pandemic has given somewhat of a reality check of the future. 

Hustle culture refers to the embracing of work as a lifestyle such that it takes over other important aspects of your life – in other words, when work-life balance becomes work-work (im)balance. It has also been aptly referred to as burnout culture or grind culture. It’s a bit ironic or counterintuitive to think that stopping work means increased productivity – but it’s true. 

During my undergraduate years, I was always hustling – there wasn’t a moment where I wasn’t studying, doing research, training for my sport, or thinking about how I could do better and be better. It was all about working 24/7 – an illusion to think I was being productive. Now don’t get me wrong, I think the time and effort I invested during those years paid off. However, it also resulted in a sense of dissatisfaction; that is, dissatisfaction that I didn’t explore other potential paths, that I didn’t have the courage to try new things and to be okay with making mistakes. I had extremely narrow tunnel vision because my one and only goal was to go to medical school. 

However, after entering graduate school and actually taking the time to explore other options and career pathways in health, as well as realize that nontraditional pathways are becoming more and more conventional, there is a sense of relief that “failure” is not about changing paths or making mistakes. 

The part of hustle culture that has me hung up is being able to take the time to reflect whether this is what you truly want. I still believe in the value of hard work but I also believe in the value of meaningful and efficient work while also taking the time to reflect. 

The pandemic has shaped a lot of the way we think, what we value, and how we proceed forward. Who we are and what we value is a continuing and ever-growing process, and how we choose to live our lives will play a part. 

I’m curious to hear from you, do you believe in #hustle? Are you part of the #grind culture? Or do you believe we can achieve success, greatness, and satisfaction without the hustle culture?
 

Ms. Lui is an MSc candidate at the University of Toronto, and is with the Mood Disorders Psychopharmacology Unit, Toronto Western Hospital. She has received income from Braxia Scientific. A version of this article first appeared on Medscape.com.

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Drunk, sleeping jurors during virtual malpractice trials

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During a recent virtual medical malpractice trial, the judge called a break, and the participants left their screens. When the trial resumed a short time later, one juror was missing. The court called his phone, but there was no answer.

“Everyone had to keep waiting and waiting while the bailiff kept trying to call,” recalled Elizabeth Leedom, a medical malpractice defense attorney based in Seattle. “The juror fell asleep.”

The sleeping juror caused a significant delay in the trial, Ms. Leedom said. Finally, he woke up, and the trial was able to continue.

In another instance, a potential juror showed up drunk to a virtual jury selection. The man was slurring his words as he answered questions, Ms. Leedom said, and when asked if he was okay, he admitted that he had a drinking problem. The judge asked whether he had consumed alcohol, and the man admitted that he’d been drinking that day. He was excused from jury selection.

These alarming incidents are among the mishaps that happen during virtual medical malpractice trials. Since the pandemic started, many courts have moved to virtual settings to slow the spread of COVID-19. Although some courts have now shifted back to in-person trials, some areas continue to mandate virtual malpractice trials, hearings, and depositions.

Such trials can save money and are convenient, but legal experts say virtual trials present serious challenges for physicians and raise concerns about fairness. Some jurors are not taking virtual cases seriously or do not stay focused on the subject matter, according to attorneys.

“Virtual trials are not as fair to physicians as in-person trials,” said Andrew DeSimone, a medical malpractice defense attorney based in Lexington, Ky. “It’s too easy not to pay attention in a virtual setting. And when you are dealing with complex medical topics, juror attention is a paramount issue.”
 

Casual settings, constant interruptions during jury selections

Understanding and reaching the jury have been the greatest challenges with virtual and hybrid trials, said Laura Eschleman, a medical liability defense attorney based in Atlanta. Hybrid trials are part virtual and part in person.

Ms. Eschleman has participated in jury selections via Zoom in which jurors lounge in bed during the process and spouses and children waltz into the room as they please, she said.

“With over 36 Zoom boxes of potential jurors, assessing each potential juror was difficult to say the least,” she said. “[Jury selection] has always been an opportunity to introduce the defendant physicians to the jurors as humans; doing it virtually took that away. It is difficult to humanize a box on a screen.”

Regarding one virtual jury selection, Ms. Eschleman said the court had narrowed the pool to a final 12 jurors when one juror’s wife burst into his room and started yelling in front of his computer.

The judge allowed her to speak, and the crying woman begged the judge not to select her husband for the trial because it would disrupt the couple’s child care. After a lengthy exchange, they learned that the child was 16 years old and had his own car. The husband disagreed with his wife and wanted to remain a juror.

“This would have never happened had the twelfth juror been called to an in-person jury selection,” Ms. Eschleman said.

Keeping juries focused while the trial is underway can also be a problem, DeSimone said. He describes the courtroom during malpractice trials as a theater of sorts. Jurors watch intently as witnesses testify, evidence is presented, and the judge gives instructions. During virtual trials, however, watching through a screen doesn’t always yield the same captive audiences, he said.

“During Zoom, it’s much harder to connect with the jury because they won’t be as tuned into it,” he said. “If the jury believes the physician is empathetic, conscientious, caring, and compassionate, they will give the physician the benefit of the doubt, even if something went wrong or a bad outcome occurred. Developing that connection through good eye contact, being a teacher, and showing compassion is the most important thing a physician can do when testifying.”

A related challenge is that medical experts can’t connect as well with jurors, and some may have trouble conveying their message from a screen, said Evan Lyman, a medical malpractice defense attorney based in White Plains, N.Y.

“Some experts like to get out of the witness box and kind of take over the courtroom with a laser pointer or a white board,” he said. “For some, that’s what makes them effective experts. Some experts lose their touch when they can’t do that.”

Technical difficulties during virtual trials can cause further woes, said Kari Adams, vice president of claims for Physicians Insurance – A Mutual Company. She recalled a recent case in which technical problems arose during the defense attorney’s closing arguments.

“It’s hard to see our defense attorneys who are used to using all of their advocacy skills, all of their charisma trying to convey it in a virtual format,” she said. “When it’s disrupted, it can really throw things. A lot of their advocacy and personality can play through, but it’s just a little less in that forum.”
 

 

 

Doc fights against virtual trial

When Texas cardiologist Amin Al-Ahmad’s malpractice trial was changed to a virtual format because of COVID-19 concerns, Dr. Al-Ahmad and his attorneys fought the move.

They argued that the malpractice case was too complex for a virtual format and that a video trial would deprive Dr. Al-Ahmad of his rights to due process, including the right to trial by jury.

Dr. Al-Ahmad’s case involved allegations that he had failed to promptly diagnose and treat an atrial esophageal fistula, resulting in a patient’s stroke and ongoing neurologic problems. The trial was expected to last up to 10 days. Nine witnesses were expected to testify, and $1 million in damages were at stake, according to court documents.

“The length of trial anticipated, complexity of the medical issues, the confidential medical information at issue, and the number of anticipated medical records exhibits lead to a real risk of juror ‘Zoom fatigue,’ even if the trial is not interrupted with technology glitches, such as jurors dropping off the link or sound loss,” Dr. Al-Ahmad’s attorneys wrote in a petition to the Texas Supreme Court. “The risks of forcing [the defendants] to trial through the procedure of a remote or virtual jury trial are numerous. Not least of these is the risk that [defendants’] relators will be prevented from presenting an adequate defense or being able to fully preserve error during a virtual trial.”

Another concern regards the lack of uniformity from county to county in conducting a virtual trial, said David A. Wright, an attorney for Dr. Al-Ahmad. Some counties don’t permit them, while others permit parties to opt out of virtual trials, he noted.

“Even those that hold virtual trials seem to have different procedures and rules,” he said. “Travis County, where I have tried my virtual cases, has iPads that they provide to each juror so that they are limited to using just the county iPad for the trial. Others, I have heard, permit jurors to use their own devices. There are simply no uniform rules.”

Despite requests to the trial court and petitions to the appellate and Texas Supreme Court, Dr. Al-Ahmad lost his bid to have his trial delayed until in-person trials resumed. The Texas Supreme Court in late 2021 refused to halt the virtual trial.

Dr. Al-Ahmad, based in Austin, declined to comment through his attorney. Mr. Wright said the court’s denial “was not unexpected.”

Dr. Al-Ahmad’s virtual trial went forward in October 2021, and the jury ruled in his favor.

“We were very pleased with the jury’s verdict,” Mr. Wright said.
 

Are virtual trials ending in higher awards?

In addition to jurors’ not taking their roles as seriously, the casual vibe of virtual trials may also be diminishing how jurors view the verdict’s magnitude.

“Virtual trials don’t have the gravity or the seriousness of a real trial,” Ms. Leedom said. “I don’t think the importance of the jury’s decision weighs on them as much during a Zoom trial as it does an in-person trial.”

Alarmingly, Ms. Leedom said that, in her experience, damages in virtual trials have been higher in comparison with damages awarded during in-person trials.

Ms. Adams agreed with this observation.

“We’ll still win cases, but we’re concerned that, in the cases we lose, the damages can be slightly higher because there hasn’t been that interpersonal connection with the defendant,” she said. “It almost becomes like monopoly money to jurors.”
 

 

 

Remember these tips during virtual trials

Physicians undergoing virtual trials may have better experiences if they keep a few tips in mind.

Mr. DeSimone emphasized the importance of eye contact with jurors, which can be tricky during virtual settings. It helps if physicians look at the camera, rather than the screen, while talking.

Physicians should be cognizant of their facial expressions as they watch others speak.

“Don’t roll your eyes like: ‘Oh my gosh, he’s an idiot,’ ” Mr. DeSimone said. “Keep a poker face. Be respectful of what’s going on. Don’t be lulled into letting your guard down.”

Before the virtual trial, practice the cross examination and direct examination with your attorney and record it, Ms. Leedom said. That way, doctors can watch how they present on video and make necessary changes before the real trial. Lighting is also important, she noted. Her firm provides special lamps to clients and witnesses for virtual trials and proceedings.

“The lighting makes a huge difference,” she said.

Its also a good idea for physicians to have a paper copy of the records or exhibits that are going to be used so it’s easy for them to flip through them while on the screen. Physicians should also be mindful of how they come across during video depositions, which are sometimes played during virtual trials, Ms. Adams said.

“If you’re not looking professional during the video deposition – you’re eating, you’re not dressed well – the plaintiff’s attorney will take the most inopportune segment of the deposition and portray the physician as: ‘Look, here’s someone who was careless in the medical care, and look, they don’t even look professional when they’re testifying about this horrifying experience,’ ” she said. “They’ll use the clips to make a very careful provider appear distracted.”
 

Are virtual trials and hearings here to stay?

Whether virtual malpractice trials continue will largely depend on the location in which physicians practice. Some insurance carriers are opting to continue virtual trials, but in some areas, trials are being delayed until in-person proceedings can resume, Ms. Adams said. Some areas never adopted video trials and never ceased in-person trials.

“I think it’s going to be very regionally based,” she said. “Some of the smaller, rural counties just don’t have the capacity or the resources to continue, so they’ll probably just go back to in person.”

Not all virtual proceedings are problematic for physicians, say legal experts. Virtual depositions can be beneficial for doctors because they are less intimidating and confrontational than in-person depositions, Mr. Lyman said.

Additionally, virtual mediations can take much less time than in-person mediations, Ms. Adams said. Video depositions and mediations also save travel costs and reduce time missed from work for physicians.

“But I hope we all go back to in-person trials,” Ms. Leedom said. “Even here in King County, [Washington,] where we’ve done federal and state court trials by Zoom, I’m hopeful that it will go back to in-person trials.”

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

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During a recent virtual medical malpractice trial, the judge called a break, and the participants left their screens. When the trial resumed a short time later, one juror was missing. The court called his phone, but there was no answer.

“Everyone had to keep waiting and waiting while the bailiff kept trying to call,” recalled Elizabeth Leedom, a medical malpractice defense attorney based in Seattle. “The juror fell asleep.”

The sleeping juror caused a significant delay in the trial, Ms. Leedom said. Finally, he woke up, and the trial was able to continue.

In another instance, a potential juror showed up drunk to a virtual jury selection. The man was slurring his words as he answered questions, Ms. Leedom said, and when asked if he was okay, he admitted that he had a drinking problem. The judge asked whether he had consumed alcohol, and the man admitted that he’d been drinking that day. He was excused from jury selection.

These alarming incidents are among the mishaps that happen during virtual medical malpractice trials. Since the pandemic started, many courts have moved to virtual settings to slow the spread of COVID-19. Although some courts have now shifted back to in-person trials, some areas continue to mandate virtual malpractice trials, hearings, and depositions.

Such trials can save money and are convenient, but legal experts say virtual trials present serious challenges for physicians and raise concerns about fairness. Some jurors are not taking virtual cases seriously or do not stay focused on the subject matter, according to attorneys.

“Virtual trials are not as fair to physicians as in-person trials,” said Andrew DeSimone, a medical malpractice defense attorney based in Lexington, Ky. “It’s too easy not to pay attention in a virtual setting. And when you are dealing with complex medical topics, juror attention is a paramount issue.”
 

Casual settings, constant interruptions during jury selections

Understanding and reaching the jury have been the greatest challenges with virtual and hybrid trials, said Laura Eschleman, a medical liability defense attorney based in Atlanta. Hybrid trials are part virtual and part in person.

Ms. Eschleman has participated in jury selections via Zoom in which jurors lounge in bed during the process and spouses and children waltz into the room as they please, she said.

“With over 36 Zoom boxes of potential jurors, assessing each potential juror was difficult to say the least,” she said. “[Jury selection] has always been an opportunity to introduce the defendant physicians to the jurors as humans; doing it virtually took that away. It is difficult to humanize a box on a screen.”

Regarding one virtual jury selection, Ms. Eschleman said the court had narrowed the pool to a final 12 jurors when one juror’s wife burst into his room and started yelling in front of his computer.

The judge allowed her to speak, and the crying woman begged the judge not to select her husband for the trial because it would disrupt the couple’s child care. After a lengthy exchange, they learned that the child was 16 years old and had his own car. The husband disagreed with his wife and wanted to remain a juror.

“This would have never happened had the twelfth juror been called to an in-person jury selection,” Ms. Eschleman said.

Keeping juries focused while the trial is underway can also be a problem, DeSimone said. He describes the courtroom during malpractice trials as a theater of sorts. Jurors watch intently as witnesses testify, evidence is presented, and the judge gives instructions. During virtual trials, however, watching through a screen doesn’t always yield the same captive audiences, he said.

“During Zoom, it’s much harder to connect with the jury because they won’t be as tuned into it,” he said. “If the jury believes the physician is empathetic, conscientious, caring, and compassionate, they will give the physician the benefit of the doubt, even if something went wrong or a bad outcome occurred. Developing that connection through good eye contact, being a teacher, and showing compassion is the most important thing a physician can do when testifying.”

A related challenge is that medical experts can’t connect as well with jurors, and some may have trouble conveying their message from a screen, said Evan Lyman, a medical malpractice defense attorney based in White Plains, N.Y.

“Some experts like to get out of the witness box and kind of take over the courtroom with a laser pointer or a white board,” he said. “For some, that’s what makes them effective experts. Some experts lose their touch when they can’t do that.”

Technical difficulties during virtual trials can cause further woes, said Kari Adams, vice president of claims for Physicians Insurance – A Mutual Company. She recalled a recent case in which technical problems arose during the defense attorney’s closing arguments.

“It’s hard to see our defense attorneys who are used to using all of their advocacy skills, all of their charisma trying to convey it in a virtual format,” she said. “When it’s disrupted, it can really throw things. A lot of their advocacy and personality can play through, but it’s just a little less in that forum.”
 

 

 

Doc fights against virtual trial

When Texas cardiologist Amin Al-Ahmad’s malpractice trial was changed to a virtual format because of COVID-19 concerns, Dr. Al-Ahmad and his attorneys fought the move.

They argued that the malpractice case was too complex for a virtual format and that a video trial would deprive Dr. Al-Ahmad of his rights to due process, including the right to trial by jury.

Dr. Al-Ahmad’s case involved allegations that he had failed to promptly diagnose and treat an atrial esophageal fistula, resulting in a patient’s stroke and ongoing neurologic problems. The trial was expected to last up to 10 days. Nine witnesses were expected to testify, and $1 million in damages were at stake, according to court documents.

“The length of trial anticipated, complexity of the medical issues, the confidential medical information at issue, and the number of anticipated medical records exhibits lead to a real risk of juror ‘Zoom fatigue,’ even if the trial is not interrupted with technology glitches, such as jurors dropping off the link or sound loss,” Dr. Al-Ahmad’s attorneys wrote in a petition to the Texas Supreme Court. “The risks of forcing [the defendants] to trial through the procedure of a remote or virtual jury trial are numerous. Not least of these is the risk that [defendants’] relators will be prevented from presenting an adequate defense or being able to fully preserve error during a virtual trial.”

Another concern regards the lack of uniformity from county to county in conducting a virtual trial, said David A. Wright, an attorney for Dr. Al-Ahmad. Some counties don’t permit them, while others permit parties to opt out of virtual trials, he noted.

“Even those that hold virtual trials seem to have different procedures and rules,” he said. “Travis County, where I have tried my virtual cases, has iPads that they provide to each juror so that they are limited to using just the county iPad for the trial. Others, I have heard, permit jurors to use their own devices. There are simply no uniform rules.”

Despite requests to the trial court and petitions to the appellate and Texas Supreme Court, Dr. Al-Ahmad lost his bid to have his trial delayed until in-person trials resumed. The Texas Supreme Court in late 2021 refused to halt the virtual trial.

Dr. Al-Ahmad, based in Austin, declined to comment through his attorney. Mr. Wright said the court’s denial “was not unexpected.”

Dr. Al-Ahmad’s virtual trial went forward in October 2021, and the jury ruled in his favor.

“We were very pleased with the jury’s verdict,” Mr. Wright said.
 

Are virtual trials ending in higher awards?

In addition to jurors’ not taking their roles as seriously, the casual vibe of virtual trials may also be diminishing how jurors view the verdict’s magnitude.

“Virtual trials don’t have the gravity or the seriousness of a real trial,” Ms. Leedom said. “I don’t think the importance of the jury’s decision weighs on them as much during a Zoom trial as it does an in-person trial.”

Alarmingly, Ms. Leedom said that, in her experience, damages in virtual trials have been higher in comparison with damages awarded during in-person trials.

Ms. Adams agreed with this observation.

“We’ll still win cases, but we’re concerned that, in the cases we lose, the damages can be slightly higher because there hasn’t been that interpersonal connection with the defendant,” she said. “It almost becomes like monopoly money to jurors.”
 

 

 

Remember these tips during virtual trials

Physicians undergoing virtual trials may have better experiences if they keep a few tips in mind.

Mr. DeSimone emphasized the importance of eye contact with jurors, which can be tricky during virtual settings. It helps if physicians look at the camera, rather than the screen, while talking.

Physicians should be cognizant of their facial expressions as they watch others speak.

“Don’t roll your eyes like: ‘Oh my gosh, he’s an idiot,’ ” Mr. DeSimone said. “Keep a poker face. Be respectful of what’s going on. Don’t be lulled into letting your guard down.”

Before the virtual trial, practice the cross examination and direct examination with your attorney and record it, Ms. Leedom said. That way, doctors can watch how they present on video and make necessary changes before the real trial. Lighting is also important, she noted. Her firm provides special lamps to clients and witnesses for virtual trials and proceedings.

“The lighting makes a huge difference,” she said.

Its also a good idea for physicians to have a paper copy of the records or exhibits that are going to be used so it’s easy for them to flip through them while on the screen. Physicians should also be mindful of how they come across during video depositions, which are sometimes played during virtual trials, Ms. Adams said.

“If you’re not looking professional during the video deposition – you’re eating, you’re not dressed well – the plaintiff’s attorney will take the most inopportune segment of the deposition and portray the physician as: ‘Look, here’s someone who was careless in the medical care, and look, they don’t even look professional when they’re testifying about this horrifying experience,’ ” she said. “They’ll use the clips to make a very careful provider appear distracted.”
 

Are virtual trials and hearings here to stay?

Whether virtual malpractice trials continue will largely depend on the location in which physicians practice. Some insurance carriers are opting to continue virtual trials, but in some areas, trials are being delayed until in-person proceedings can resume, Ms. Adams said. Some areas never adopted video trials and never ceased in-person trials.

“I think it’s going to be very regionally based,” she said. “Some of the smaller, rural counties just don’t have the capacity or the resources to continue, so they’ll probably just go back to in person.”

Not all virtual proceedings are problematic for physicians, say legal experts. Virtual depositions can be beneficial for doctors because they are less intimidating and confrontational than in-person depositions, Mr. Lyman said.

Additionally, virtual mediations can take much less time than in-person mediations, Ms. Adams said. Video depositions and mediations also save travel costs and reduce time missed from work for physicians.

“But I hope we all go back to in-person trials,” Ms. Leedom said. “Even here in King County, [Washington,] where we’ve done federal and state court trials by Zoom, I’m hopeful that it will go back to in-person trials.”

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

During a recent virtual medical malpractice trial, the judge called a break, and the participants left their screens. When the trial resumed a short time later, one juror was missing. The court called his phone, but there was no answer.

“Everyone had to keep waiting and waiting while the bailiff kept trying to call,” recalled Elizabeth Leedom, a medical malpractice defense attorney based in Seattle. “The juror fell asleep.”

The sleeping juror caused a significant delay in the trial, Ms. Leedom said. Finally, he woke up, and the trial was able to continue.

In another instance, a potential juror showed up drunk to a virtual jury selection. The man was slurring his words as he answered questions, Ms. Leedom said, and when asked if he was okay, he admitted that he had a drinking problem. The judge asked whether he had consumed alcohol, and the man admitted that he’d been drinking that day. He was excused from jury selection.

These alarming incidents are among the mishaps that happen during virtual medical malpractice trials. Since the pandemic started, many courts have moved to virtual settings to slow the spread of COVID-19. Although some courts have now shifted back to in-person trials, some areas continue to mandate virtual malpractice trials, hearings, and depositions.

Such trials can save money and are convenient, but legal experts say virtual trials present serious challenges for physicians and raise concerns about fairness. Some jurors are not taking virtual cases seriously or do not stay focused on the subject matter, according to attorneys.

“Virtual trials are not as fair to physicians as in-person trials,” said Andrew DeSimone, a medical malpractice defense attorney based in Lexington, Ky. “It’s too easy not to pay attention in a virtual setting. And when you are dealing with complex medical topics, juror attention is a paramount issue.”
 

Casual settings, constant interruptions during jury selections

Understanding and reaching the jury have been the greatest challenges with virtual and hybrid trials, said Laura Eschleman, a medical liability defense attorney based in Atlanta. Hybrid trials are part virtual and part in person.

Ms. Eschleman has participated in jury selections via Zoom in which jurors lounge in bed during the process and spouses and children waltz into the room as they please, she said.

“With over 36 Zoom boxes of potential jurors, assessing each potential juror was difficult to say the least,” she said. “[Jury selection] has always been an opportunity to introduce the defendant physicians to the jurors as humans; doing it virtually took that away. It is difficult to humanize a box on a screen.”

Regarding one virtual jury selection, Ms. Eschleman said the court had narrowed the pool to a final 12 jurors when one juror’s wife burst into his room and started yelling in front of his computer.

The judge allowed her to speak, and the crying woman begged the judge not to select her husband for the trial because it would disrupt the couple’s child care. After a lengthy exchange, they learned that the child was 16 years old and had his own car. The husband disagreed with his wife and wanted to remain a juror.

“This would have never happened had the twelfth juror been called to an in-person jury selection,” Ms. Eschleman said.

Keeping juries focused while the trial is underway can also be a problem, DeSimone said. He describes the courtroom during malpractice trials as a theater of sorts. Jurors watch intently as witnesses testify, evidence is presented, and the judge gives instructions. During virtual trials, however, watching through a screen doesn’t always yield the same captive audiences, he said.

“During Zoom, it’s much harder to connect with the jury because they won’t be as tuned into it,” he said. “If the jury believes the physician is empathetic, conscientious, caring, and compassionate, they will give the physician the benefit of the doubt, even if something went wrong or a bad outcome occurred. Developing that connection through good eye contact, being a teacher, and showing compassion is the most important thing a physician can do when testifying.”

A related challenge is that medical experts can’t connect as well with jurors, and some may have trouble conveying their message from a screen, said Evan Lyman, a medical malpractice defense attorney based in White Plains, N.Y.

“Some experts like to get out of the witness box and kind of take over the courtroom with a laser pointer or a white board,” he said. “For some, that’s what makes them effective experts. Some experts lose their touch when they can’t do that.”

Technical difficulties during virtual trials can cause further woes, said Kari Adams, vice president of claims for Physicians Insurance – A Mutual Company. She recalled a recent case in which technical problems arose during the defense attorney’s closing arguments.

“It’s hard to see our defense attorneys who are used to using all of their advocacy skills, all of their charisma trying to convey it in a virtual format,” she said. “When it’s disrupted, it can really throw things. A lot of their advocacy and personality can play through, but it’s just a little less in that forum.”
 

 

 

Doc fights against virtual trial

When Texas cardiologist Amin Al-Ahmad’s malpractice trial was changed to a virtual format because of COVID-19 concerns, Dr. Al-Ahmad and his attorneys fought the move.

They argued that the malpractice case was too complex for a virtual format and that a video trial would deprive Dr. Al-Ahmad of his rights to due process, including the right to trial by jury.

Dr. Al-Ahmad’s case involved allegations that he had failed to promptly diagnose and treat an atrial esophageal fistula, resulting in a patient’s stroke and ongoing neurologic problems. The trial was expected to last up to 10 days. Nine witnesses were expected to testify, and $1 million in damages were at stake, according to court documents.

“The length of trial anticipated, complexity of the medical issues, the confidential medical information at issue, and the number of anticipated medical records exhibits lead to a real risk of juror ‘Zoom fatigue,’ even if the trial is not interrupted with technology glitches, such as jurors dropping off the link or sound loss,” Dr. Al-Ahmad’s attorneys wrote in a petition to the Texas Supreme Court. “The risks of forcing [the defendants] to trial through the procedure of a remote or virtual jury trial are numerous. Not least of these is the risk that [defendants’] relators will be prevented from presenting an adequate defense or being able to fully preserve error during a virtual trial.”

Another concern regards the lack of uniformity from county to county in conducting a virtual trial, said David A. Wright, an attorney for Dr. Al-Ahmad. Some counties don’t permit them, while others permit parties to opt out of virtual trials, he noted.

“Even those that hold virtual trials seem to have different procedures and rules,” he said. “Travis County, where I have tried my virtual cases, has iPads that they provide to each juror so that they are limited to using just the county iPad for the trial. Others, I have heard, permit jurors to use their own devices. There are simply no uniform rules.”

Despite requests to the trial court and petitions to the appellate and Texas Supreme Court, Dr. Al-Ahmad lost his bid to have his trial delayed until in-person trials resumed. The Texas Supreme Court in late 2021 refused to halt the virtual trial.

Dr. Al-Ahmad, based in Austin, declined to comment through his attorney. Mr. Wright said the court’s denial “was not unexpected.”

Dr. Al-Ahmad’s virtual trial went forward in October 2021, and the jury ruled in his favor.

“We were very pleased with the jury’s verdict,” Mr. Wright said.
 

Are virtual trials ending in higher awards?

In addition to jurors’ not taking their roles as seriously, the casual vibe of virtual trials may also be diminishing how jurors view the verdict’s magnitude.

“Virtual trials don’t have the gravity or the seriousness of a real trial,” Ms. Leedom said. “I don’t think the importance of the jury’s decision weighs on them as much during a Zoom trial as it does an in-person trial.”

Alarmingly, Ms. Leedom said that, in her experience, damages in virtual trials have been higher in comparison with damages awarded during in-person trials.

Ms. Adams agreed with this observation.

“We’ll still win cases, but we’re concerned that, in the cases we lose, the damages can be slightly higher because there hasn’t been that interpersonal connection with the defendant,” she said. “It almost becomes like monopoly money to jurors.”
 

 

 

Remember these tips during virtual trials

Physicians undergoing virtual trials may have better experiences if they keep a few tips in mind.

Mr. DeSimone emphasized the importance of eye contact with jurors, which can be tricky during virtual settings. It helps if physicians look at the camera, rather than the screen, while talking.

Physicians should be cognizant of their facial expressions as they watch others speak.

“Don’t roll your eyes like: ‘Oh my gosh, he’s an idiot,’ ” Mr. DeSimone said. “Keep a poker face. Be respectful of what’s going on. Don’t be lulled into letting your guard down.”

Before the virtual trial, practice the cross examination and direct examination with your attorney and record it, Ms. Leedom said. That way, doctors can watch how they present on video and make necessary changes before the real trial. Lighting is also important, she noted. Her firm provides special lamps to clients and witnesses for virtual trials and proceedings.

“The lighting makes a huge difference,” she said.

Its also a good idea for physicians to have a paper copy of the records or exhibits that are going to be used so it’s easy for them to flip through them while on the screen. Physicians should also be mindful of how they come across during video depositions, which are sometimes played during virtual trials, Ms. Adams said.

“If you’re not looking professional during the video deposition – you’re eating, you’re not dressed well – the plaintiff’s attorney will take the most inopportune segment of the deposition and portray the physician as: ‘Look, here’s someone who was careless in the medical care, and look, they don’t even look professional when they’re testifying about this horrifying experience,’ ” she said. “They’ll use the clips to make a very careful provider appear distracted.”
 

Are virtual trials and hearings here to stay?

Whether virtual malpractice trials continue will largely depend on the location in which physicians practice. Some insurance carriers are opting to continue virtual trials, but in some areas, trials are being delayed until in-person proceedings can resume, Ms. Adams said. Some areas never adopted video trials and never ceased in-person trials.

“I think it’s going to be very regionally based,” she said. “Some of the smaller, rural counties just don’t have the capacity or the resources to continue, so they’ll probably just go back to in person.”

Not all virtual proceedings are problematic for physicians, say legal experts. Virtual depositions can be beneficial for doctors because they are less intimidating and confrontational than in-person depositions, Mr. Lyman said.

Additionally, virtual mediations can take much less time than in-person mediations, Ms. Adams said. Video depositions and mediations also save travel costs and reduce time missed from work for physicians.

“But I hope we all go back to in-person trials,” Ms. Leedom said. “Even here in King County, [Washington,] where we’ve done federal and state court trials by Zoom, I’m hopeful that it will go back to in-person trials.”

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

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Neuropsychiatric outcomes similar for hospitalized COVID-19 patients and non–COVID-19 patients

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Hospitalized COVID-19 survivors showed greater cognitive impairment 6 months later, compared with patients hospitalized for other causes, but the overall disease burden was similar, based on data from 85 adults with COVID-19.

Previous studies have shown that cognitive and neuropsychiatric symptoms can occur from 2-6 months after COVID-19 recovery, and such symptoms are known to be associated with hospitalization for other severe medical conditions, Vardan Nersesjan, MD, of Copenhagen University Hospital, and colleagues wrote.

However, it remains unknown if COVID-19 is associated with a unique pattern of cognitive and mental impairment compared with other similarly severe medical conditions, they said.

In a study published in JAMA Psychiatry (2022 Mar 23. doi: 10.1001/jamapsychiatry.2022.0284), the researchers identified 85 adult COVID-19 survivors and 61 controls with non-COVID medical conditions who were treated and released between July 2020 and July 2021. The COVID-19 patients and controls were matched for age, sex, and ICU status. Cognitive impairment was assessed using the Mini-International Neuropsychiatric Interview, the Montreal Cognitive Assessment (MoCA), neurologic examination, and a semistructured interview to determine subjective symptoms.

The primary outcomes were the total scores on the MoCA and any new-onset psychiatric diagnoses. Secondary outcomes included specific psychiatric diagnoses such as depression, neurologic examination findings, and self-reported neuropsychiatric and cognitive symptoms. The mean age of the COVID-19 patients was 56.8 years, and 42% were women.

At 6 months’ follow-up, cognitive status was significantly lower in COVID-19 survivors, compared with controls, based on total geometric mean MoCA scores (26.7 vs. 27.5, P = .01). However, cognitive status improved significantly from 19.2 at hospital discharge to 26.1 at 6 months in 15 of the COVID-19 patients (P = .004), the researchers noted.

New-onset psychiatric diagnoses occurred in 16 COVID-19 patients and 12 of the controls (19% vs. 20%); this difference was not significant.

Secondary outcomes were not significantly different at 6 months between the groups, with the exception of anosmia, which was significantly more common in the COVID-19 patients; however, the significance disappeared in adjusted analysis, the researchers said.

The study findings were limited by several factors including the inability to prove causality because of the case-control feature and by the inability to detect small differences in neuropsychiatric outcomes, the researchers noted.

However, the results were strengthened by the use of a prospectively matched control group with similar disease severity admitted to the same hospital in the same time frame. Although the overall burden of neuropsychiatric and neurologic symptoms and diagnoses appeared similar in COVID-19 patients and those with other medical conditions, more research in larger populations is needed to determine smaller differences in neuropsychiatric profiles, the researchers noted.

 

 

Study fills research gap

The study is important at this time because, although prolonged neuropsychiatric and cognitive symptoms have been reported after COVID-19, the field lacked prospective case-control studies with well-matched controls to investigate whether these outcomes differed from those seen in other critical illnesses that had also required hospitalization, corresponding author Michael E. Benros, MD, of the Mental Health Center, Copenhagen, said in an interview.

Dr. Michael Benros

“I was surprised that there was a significant worse cognitive functioning among COVID-19 patients 6 months after symptom onset also when compared to this well-matched control group that had been hospitalized for non–COVID-19 illness, although the absolute difference between the groups in cognition score were small,” said Dr. Benros. “Another notable finding is the large improvement in cognitive functioning from discharge to follow-up,” he added on behalf of himself and fellow corresponding author Daniel Kondziella, MD.

The study results show that cognitive function affected by COVID-19 and critical illness as observed at discharge showed a substantial improvement at 6 months after symptom onset, said Dr. Benros. “However, the cognitive function was significantly worse among severely ill COVID-19 patients 6 months after symptom onset when compared to a matched control group of individuals hospitalized for non–COVID-19 illness, although this difference in cognitive function was rather small in absolute numbers, and smaller than what had been suggested by other studies that lacked control groups. Strikingly, neuropsychiatric disorders were similar across the two groups, which was also the case when looking at neuropsychiatric symptoms.

“Larger prospective case-control studies of neuropsychiatric and cognitive functioning after COVID-19, compared with matched controls are still needed to detect smaller differences, and more detailed cognitive domains, and with longer follow-up time, which we are currently conducting,” Dr. Benros said.  
 

Controlled studies will help planning

“Lingering neuropsychiatric complications are common after COVID-19, but only controlled studies can tell us whether these complications are specific to COVID-19, rather than a general effect of having been medically ill,” Alasdair G. Rooney, MRCPsych MD PhD, of the University of Edinburgh, said in an interview. “The answer matters ultimately because COVID-19 is a new disease; societies and health care services need to be able to plan for its specific consequences.”

Dr. Alasdair G. Rooney

The health status of the control group is important as well. “Most previous studies had compared COVID-19 survivors against healthy controls or patients from a historical database. This new study compared COVID-19 survivors against those hospitalized for other medical causes over the same period,” Dr. Rooney said. “This is a more stringent test of whether COVID-19 has specific neurocognitive and neuropsychiatric consequences.

“The study found that new-onset neuropsychiatric diagnoses and symptoms were no more likely to occur after COVID-19 than after similarly severe medical illnesses,” Dr. Rooney said. “This negative finding runs counter to some earlier studies and may surprise some.” The findings need to be replicated in larger samples, but the current study shows the importance of prospectively recruiting active controls.

“In a subgroup analysis, some patients showed good improvement in cognitive scores between discharge and follow-up. While unsurprising, this is encouraging and suggests that the early postdischarge months are an important time for neurocognitive recovery,” Dr. Rooney noted.

“The findings suggest that COVID-19 may impair attention more selectively than other medical causes of hospitalization. COVID-19 survivors may also be at higher risk of significant overall cognitive impairment than survivors of similarly severe medical illnesses, after a similar duration,” said Dr. Rooney. “If the results are replicated by other prospective studies, they would suggest that there is something about COVID-19 that causes clinically significant neurocognitive difficulties in a minority of survivors.

“Larger well-controlled studies are required, with longer follow-up and more detailed neurocognitive testing,” as the duration of impairment and scope for further recovery are not known, Dr. Rooney added. Also unknown is whether COVID-19 affects attention permanently, or whether recovery is simply slower after COVID-19 compared to other medical illnesses.

“Knowing who is at the greatest risk of severe cognitive impairment after COVID-19 is important and likely to allow tailoring of more effective shielding strategies,” said Dr. Rooney. “This study was conducted before the widespread availability of vaccines for COVID-19. Long-term neuropsychiatric outcomes in vaccinated patients remain largely unknown. Arguably, these are now more important to understand, as future COVID-19 waves will occur mainly among vaccinated individuals.”

The study was supported by the Lundbeck Foundation and the Novo Nordisk Foundation. Lead author Dr. Nersesjan had no financial conflicts to disclose. Dr. Benros reported grants from Lundbeck Foundation and Novo Nordisk Foundation during the conduct of the study. Dr. Rooney had no financial conflicts to disclose.

This article was updated 3/25/22.

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Hospitalized COVID-19 survivors showed greater cognitive impairment 6 months later, compared with patients hospitalized for other causes, but the overall disease burden was similar, based on data from 85 adults with COVID-19.

Previous studies have shown that cognitive and neuropsychiatric symptoms can occur from 2-6 months after COVID-19 recovery, and such symptoms are known to be associated with hospitalization for other severe medical conditions, Vardan Nersesjan, MD, of Copenhagen University Hospital, and colleagues wrote.

However, it remains unknown if COVID-19 is associated with a unique pattern of cognitive and mental impairment compared with other similarly severe medical conditions, they said.

In a study published in JAMA Psychiatry (2022 Mar 23. doi: 10.1001/jamapsychiatry.2022.0284), the researchers identified 85 adult COVID-19 survivors and 61 controls with non-COVID medical conditions who were treated and released between July 2020 and July 2021. The COVID-19 patients and controls were matched for age, sex, and ICU status. Cognitive impairment was assessed using the Mini-International Neuropsychiatric Interview, the Montreal Cognitive Assessment (MoCA), neurologic examination, and a semistructured interview to determine subjective symptoms.

The primary outcomes were the total scores on the MoCA and any new-onset psychiatric diagnoses. Secondary outcomes included specific psychiatric diagnoses such as depression, neurologic examination findings, and self-reported neuropsychiatric and cognitive symptoms. The mean age of the COVID-19 patients was 56.8 years, and 42% were women.

At 6 months’ follow-up, cognitive status was significantly lower in COVID-19 survivors, compared with controls, based on total geometric mean MoCA scores (26.7 vs. 27.5, P = .01). However, cognitive status improved significantly from 19.2 at hospital discharge to 26.1 at 6 months in 15 of the COVID-19 patients (P = .004), the researchers noted.

New-onset psychiatric diagnoses occurred in 16 COVID-19 patients and 12 of the controls (19% vs. 20%); this difference was not significant.

Secondary outcomes were not significantly different at 6 months between the groups, with the exception of anosmia, which was significantly more common in the COVID-19 patients; however, the significance disappeared in adjusted analysis, the researchers said.

The study findings were limited by several factors including the inability to prove causality because of the case-control feature and by the inability to detect small differences in neuropsychiatric outcomes, the researchers noted.

However, the results were strengthened by the use of a prospectively matched control group with similar disease severity admitted to the same hospital in the same time frame. Although the overall burden of neuropsychiatric and neurologic symptoms and diagnoses appeared similar in COVID-19 patients and those with other medical conditions, more research in larger populations is needed to determine smaller differences in neuropsychiatric profiles, the researchers noted.

 

 

Study fills research gap

The study is important at this time because, although prolonged neuropsychiatric and cognitive symptoms have been reported after COVID-19, the field lacked prospective case-control studies with well-matched controls to investigate whether these outcomes differed from those seen in other critical illnesses that had also required hospitalization, corresponding author Michael E. Benros, MD, of the Mental Health Center, Copenhagen, said in an interview.

Dr. Michael Benros

“I was surprised that there was a significant worse cognitive functioning among COVID-19 patients 6 months after symptom onset also when compared to this well-matched control group that had been hospitalized for non–COVID-19 illness, although the absolute difference between the groups in cognition score were small,” said Dr. Benros. “Another notable finding is the large improvement in cognitive functioning from discharge to follow-up,” he added on behalf of himself and fellow corresponding author Daniel Kondziella, MD.

The study results show that cognitive function affected by COVID-19 and critical illness as observed at discharge showed a substantial improvement at 6 months after symptom onset, said Dr. Benros. “However, the cognitive function was significantly worse among severely ill COVID-19 patients 6 months after symptom onset when compared to a matched control group of individuals hospitalized for non–COVID-19 illness, although this difference in cognitive function was rather small in absolute numbers, and smaller than what had been suggested by other studies that lacked control groups. Strikingly, neuropsychiatric disorders were similar across the two groups, which was also the case when looking at neuropsychiatric symptoms.

“Larger prospective case-control studies of neuropsychiatric and cognitive functioning after COVID-19, compared with matched controls are still needed to detect smaller differences, and more detailed cognitive domains, and with longer follow-up time, which we are currently conducting,” Dr. Benros said.  
 

Controlled studies will help planning

“Lingering neuropsychiatric complications are common after COVID-19, but only controlled studies can tell us whether these complications are specific to COVID-19, rather than a general effect of having been medically ill,” Alasdair G. Rooney, MRCPsych MD PhD, of the University of Edinburgh, said in an interview. “The answer matters ultimately because COVID-19 is a new disease; societies and health care services need to be able to plan for its specific consequences.”

Dr. Alasdair G. Rooney

The health status of the control group is important as well. “Most previous studies had compared COVID-19 survivors against healthy controls or patients from a historical database. This new study compared COVID-19 survivors against those hospitalized for other medical causes over the same period,” Dr. Rooney said. “This is a more stringent test of whether COVID-19 has specific neurocognitive and neuropsychiatric consequences.

“The study found that new-onset neuropsychiatric diagnoses and symptoms were no more likely to occur after COVID-19 than after similarly severe medical illnesses,” Dr. Rooney said. “This negative finding runs counter to some earlier studies and may surprise some.” The findings need to be replicated in larger samples, but the current study shows the importance of prospectively recruiting active controls.

“In a subgroup analysis, some patients showed good improvement in cognitive scores between discharge and follow-up. While unsurprising, this is encouraging and suggests that the early postdischarge months are an important time for neurocognitive recovery,” Dr. Rooney noted.

“The findings suggest that COVID-19 may impair attention more selectively than other medical causes of hospitalization. COVID-19 survivors may also be at higher risk of significant overall cognitive impairment than survivors of similarly severe medical illnesses, after a similar duration,” said Dr. Rooney. “If the results are replicated by other prospective studies, they would suggest that there is something about COVID-19 that causes clinically significant neurocognitive difficulties in a minority of survivors.

“Larger well-controlled studies are required, with longer follow-up and more detailed neurocognitive testing,” as the duration of impairment and scope for further recovery are not known, Dr. Rooney added. Also unknown is whether COVID-19 affects attention permanently, or whether recovery is simply slower after COVID-19 compared to other medical illnesses.

“Knowing who is at the greatest risk of severe cognitive impairment after COVID-19 is important and likely to allow tailoring of more effective shielding strategies,” said Dr. Rooney. “This study was conducted before the widespread availability of vaccines for COVID-19. Long-term neuropsychiatric outcomes in vaccinated patients remain largely unknown. Arguably, these are now more important to understand, as future COVID-19 waves will occur mainly among vaccinated individuals.”

The study was supported by the Lundbeck Foundation and the Novo Nordisk Foundation. Lead author Dr. Nersesjan had no financial conflicts to disclose. Dr. Benros reported grants from Lundbeck Foundation and Novo Nordisk Foundation during the conduct of the study. Dr. Rooney had no financial conflicts to disclose.

This article was updated 3/25/22.

Hospitalized COVID-19 survivors showed greater cognitive impairment 6 months later, compared with patients hospitalized for other causes, but the overall disease burden was similar, based on data from 85 adults with COVID-19.

Previous studies have shown that cognitive and neuropsychiatric symptoms can occur from 2-6 months after COVID-19 recovery, and such symptoms are known to be associated with hospitalization for other severe medical conditions, Vardan Nersesjan, MD, of Copenhagen University Hospital, and colleagues wrote.

However, it remains unknown if COVID-19 is associated with a unique pattern of cognitive and mental impairment compared with other similarly severe medical conditions, they said.

In a study published in JAMA Psychiatry (2022 Mar 23. doi: 10.1001/jamapsychiatry.2022.0284), the researchers identified 85 adult COVID-19 survivors and 61 controls with non-COVID medical conditions who were treated and released between July 2020 and July 2021. The COVID-19 patients and controls were matched for age, sex, and ICU status. Cognitive impairment was assessed using the Mini-International Neuropsychiatric Interview, the Montreal Cognitive Assessment (MoCA), neurologic examination, and a semistructured interview to determine subjective symptoms.

The primary outcomes were the total scores on the MoCA and any new-onset psychiatric diagnoses. Secondary outcomes included specific psychiatric diagnoses such as depression, neurologic examination findings, and self-reported neuropsychiatric and cognitive symptoms. The mean age of the COVID-19 patients was 56.8 years, and 42% were women.

At 6 months’ follow-up, cognitive status was significantly lower in COVID-19 survivors, compared with controls, based on total geometric mean MoCA scores (26.7 vs. 27.5, P = .01). However, cognitive status improved significantly from 19.2 at hospital discharge to 26.1 at 6 months in 15 of the COVID-19 patients (P = .004), the researchers noted.

New-onset psychiatric diagnoses occurred in 16 COVID-19 patients and 12 of the controls (19% vs. 20%); this difference was not significant.

Secondary outcomes were not significantly different at 6 months between the groups, with the exception of anosmia, which was significantly more common in the COVID-19 patients; however, the significance disappeared in adjusted analysis, the researchers said.

The study findings were limited by several factors including the inability to prove causality because of the case-control feature and by the inability to detect small differences in neuropsychiatric outcomes, the researchers noted.

However, the results were strengthened by the use of a prospectively matched control group with similar disease severity admitted to the same hospital in the same time frame. Although the overall burden of neuropsychiatric and neurologic symptoms and diagnoses appeared similar in COVID-19 patients and those with other medical conditions, more research in larger populations is needed to determine smaller differences in neuropsychiatric profiles, the researchers noted.

 

 

Study fills research gap

The study is important at this time because, although prolonged neuropsychiatric and cognitive symptoms have been reported after COVID-19, the field lacked prospective case-control studies with well-matched controls to investigate whether these outcomes differed from those seen in other critical illnesses that had also required hospitalization, corresponding author Michael E. Benros, MD, of the Mental Health Center, Copenhagen, said in an interview.

Dr. Michael Benros

“I was surprised that there was a significant worse cognitive functioning among COVID-19 patients 6 months after symptom onset also when compared to this well-matched control group that had been hospitalized for non–COVID-19 illness, although the absolute difference between the groups in cognition score were small,” said Dr. Benros. “Another notable finding is the large improvement in cognitive functioning from discharge to follow-up,” he added on behalf of himself and fellow corresponding author Daniel Kondziella, MD.

The study results show that cognitive function affected by COVID-19 and critical illness as observed at discharge showed a substantial improvement at 6 months after symptom onset, said Dr. Benros. “However, the cognitive function was significantly worse among severely ill COVID-19 patients 6 months after symptom onset when compared to a matched control group of individuals hospitalized for non–COVID-19 illness, although this difference in cognitive function was rather small in absolute numbers, and smaller than what had been suggested by other studies that lacked control groups. Strikingly, neuropsychiatric disorders were similar across the two groups, which was also the case when looking at neuropsychiatric symptoms.

“Larger prospective case-control studies of neuropsychiatric and cognitive functioning after COVID-19, compared with matched controls are still needed to detect smaller differences, and more detailed cognitive domains, and with longer follow-up time, which we are currently conducting,” Dr. Benros said.  
 

Controlled studies will help planning

“Lingering neuropsychiatric complications are common after COVID-19, but only controlled studies can tell us whether these complications are specific to COVID-19, rather than a general effect of having been medically ill,” Alasdair G. Rooney, MRCPsych MD PhD, of the University of Edinburgh, said in an interview. “The answer matters ultimately because COVID-19 is a new disease; societies and health care services need to be able to plan for its specific consequences.”

Dr. Alasdair G. Rooney

The health status of the control group is important as well. “Most previous studies had compared COVID-19 survivors against healthy controls or patients from a historical database. This new study compared COVID-19 survivors against those hospitalized for other medical causes over the same period,” Dr. Rooney said. “This is a more stringent test of whether COVID-19 has specific neurocognitive and neuropsychiatric consequences.

“The study found that new-onset neuropsychiatric diagnoses and symptoms were no more likely to occur after COVID-19 than after similarly severe medical illnesses,” Dr. Rooney said. “This negative finding runs counter to some earlier studies and may surprise some.” The findings need to be replicated in larger samples, but the current study shows the importance of prospectively recruiting active controls.

“In a subgroup analysis, some patients showed good improvement in cognitive scores between discharge and follow-up. While unsurprising, this is encouraging and suggests that the early postdischarge months are an important time for neurocognitive recovery,” Dr. Rooney noted.

“The findings suggest that COVID-19 may impair attention more selectively than other medical causes of hospitalization. COVID-19 survivors may also be at higher risk of significant overall cognitive impairment than survivors of similarly severe medical illnesses, after a similar duration,” said Dr. Rooney. “If the results are replicated by other prospective studies, they would suggest that there is something about COVID-19 that causes clinically significant neurocognitive difficulties in a minority of survivors.

“Larger well-controlled studies are required, with longer follow-up and more detailed neurocognitive testing,” as the duration of impairment and scope for further recovery are not known, Dr. Rooney added. Also unknown is whether COVID-19 affects attention permanently, or whether recovery is simply slower after COVID-19 compared to other medical illnesses.

“Knowing who is at the greatest risk of severe cognitive impairment after COVID-19 is important and likely to allow tailoring of more effective shielding strategies,” said Dr. Rooney. “This study was conducted before the widespread availability of vaccines for COVID-19. Long-term neuropsychiatric outcomes in vaccinated patients remain largely unknown. Arguably, these are now more important to understand, as future COVID-19 waves will occur mainly among vaccinated individuals.”

The study was supported by the Lundbeck Foundation and the Novo Nordisk Foundation. Lead author Dr. Nersesjan had no financial conflicts to disclose. Dr. Benros reported grants from Lundbeck Foundation and Novo Nordisk Foundation during the conduct of the study. Dr. Rooney had no financial conflicts to disclose.

This article was updated 3/25/22.

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