MDedge Pediatrics

Longer cumulative use of medication to treat attention-deficit/hyperactivity disorder (ADHD) is associated with a small, but statistically significant, increased risk for cardiovascular disease (CVD), results of a large Swedish nested case-control study suggest.

The increased risk was evident only for hypertension and arterial disease, was dose dependent, and was higher for stimulant than nonstimulant ADHD medications.

“Clinicians should be vigilant in monitoring signs and symptoms of cardiovascular diseases, particularly among those receiving higher doses,” Zheng Chang, PhD, principal researcher, department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, said in an interview.

“Treatment decisions, as always, should be based on careful weighing of potential benefits and risks at individual patient level, rather than simple one-size-fits-all recommendations,” Dr. Chang added.

The study was published online in JAMA Psychiatry

Filling in the research gaps

The use of medications to treat ADHD has increased markedly over the past decades in both children and adults. The potential risk for CVD associated with long-term ADHD medication use remains unclear. Most “longitudinal” studies that have looked at the association have an average follow-up time of no more than 2 years, the authors note.

In contrast, the Swedish study assessed the association between cumulative use of ADHD medication in children and adults followed for up to 14 years and also looked at whether associations differ across types of medication and dosages, types of CVD, gender, and age.

Among 278,027 individuals aged 6-64 years diagnosed with ADHD or dispensed ADHD medication, 10,388 with CVD were identified and matched to 51,672 controls without CVD.

Longer cumulative duration of ADHD medication use was associated with a statistically significant increased risk for CVD, compared with no use.

When the risk for specific CVDs was examined, long-term use of ADHD medication (compared with no use) was associated with an increased risk for hypertension and arterial disease but not arrhythmias, heart failure, ischemic heart disease, thromboembolic disease, or cerebrovascular disease.

For hypertension, the adjusted odds ratio was 1.72 (95% confidence interval, 1.51-1.97) for 3 to ≤ 5 years and 1.80 (95% CI, 1.55-2.08) for > 5 years of medication use. For arterial disease, the AOR was 1.65 (95% CI, 1.11-2.45) for 3 to ≤ 5 years and 1.49 (95% CI, 0.96-2.32) for > 5 years of use.
 

Stimulants confer greatest risk

Across the 14-year follow-up period, each additional year of ADHD medication use was associated with an average 4% increased CVD risk, with a larger 8% increased risk in the first 3 years of cumulative use, followed by stable risk over the remaining follow-up.

Similar risks were observed in children and adults, as well as in females and males.

When focusing on specific ADHD medications, compared with no use, long-term use of the stimulant methylphenidate was associated with an increased risk for CVD (AOR, 1.20 [95% CI, 1.10-1.31] for 3 to ≤ 5 years and 1.19 [95% CI, 1.08-1.31] for > 5 years).

The same was true for long-term use of the stimulant lisdexamfetamine (AOR, 1.23 [95% CI, 1.05-1.44] for 2 to ≤ 3 years and 1.17 [95% CI, 0.98-1.40] for > 3 years).

In contrast, use of the nonstimulant atomoxetine was associated with elevated CVD risk only for the first year of use (AOR, 1.07; 95% CI, 1.01-1.13).

The increased risk for CVD occurred only above certain average daily doses: 45 mg for methylphenidate and lisdexamfetamine, 22.5 mg for amphetamines, and 120 mg for atomoxetine.

The authors note that, although they accounted for a wide range of potential confounding variables, considering the observational nature of the study and the possibility of residual confounding, they could not prove causality.

‘Tricky trade-offs’

The coauthors of an editorial in JAMA Psychiatry (2023 Nov 22. doi: 10.1001/jamapsychiatry.2023.4126) note that the study “should remind us that clinical decision-making is often based on tricky trade-offs that should be considered at the individual patient level.”

Given that hypertension is the leading cause of CV morbidity and mortality worldwide, the increased likelihood of hypertension with long-term use of ADHD medications “cannot be disregarded,” write Samuele Cortese, MD, PhD, and Cristiano Fava, MD, PhD, with University of Southampton (England).

“These findings are especially relevant given the reported association between ADHD and physical conditions, such as obesity, which further contribute to increased cardiovascular risk,” they add.

Dr. Cortese and Dr. Fava say that the increased CV risk – averaging 4% per year and stabilizing after 3 years of treatment – “should be carefully weighed against the established benefits, on a case-by-case basis.”

“Importantly,” they write, “large real-world self-controlled studies have shown that individuals with ADHD experience significantly fewer unintentional physical injuries, motor vehicle crashes, substance use disorders, and criminal acts, as well as improved academic functioning, during periods when they are taking, compared with periods when they are not taking, methylphenidate.”

The risk-benefit ratio, however, may be lower in people with preexisting heart conditions. However, more evidence and precise recommendations are needed in relation to the treatment of individuals with ADHD and preexisting CV conditions, the editorial writers say.

This study was supported by grants from the Swedish Research Council for Health, Working Life, and Welfare and the European Union’s Horizon 2020 research and innovation program. The authors and editorial writers have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Longer cumulative use of medication to treat attention-deficit/hyperactivity disorder (ADHD) is associated with a small, but statistically significant, increased risk for cardiovascular disease (CVD), results of a large Swedish nested case-control study suggest.

The increased risk was evident only for hypertension and arterial disease, was dose dependent, and was higher for stimulant than nonstimulant ADHD medications.

“Clinicians should be vigilant in monitoring signs and symptoms of cardiovascular diseases, particularly among those receiving higher doses,” Zheng Chang, PhD, principal researcher, department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, said in an interview.

“Treatment decisions, as always, should be based on careful weighing of potential benefits and risks at individual patient level, rather than simple one-size-fits-all recommendations,” Dr. Chang added.

The study was published online in JAMA Psychiatry

Filling in the research gaps

The use of medications to treat ADHD has increased markedly over the past decades in both children and adults. The potential risk for CVD associated with long-term ADHD medication use remains unclear. Most “longitudinal” studies that have looked at the association have an average follow-up time of no more than 2 years, the authors note.

In contrast, the Swedish study assessed the association between cumulative use of ADHD medication in children and adults followed for up to 14 years and also looked at whether associations differ across types of medication and dosages, types of CVD, gender, and age.

Among 278,027 individuals aged 6-64 years diagnosed with ADHD or dispensed ADHD medication, 10,388 with CVD were identified and matched to 51,672 controls without CVD.

Longer cumulative duration of ADHD medication use was associated with a statistically significant increased risk for CVD, compared with no use.

When the risk for specific CVDs was examined, long-term use of ADHD medication (compared with no use) was associated with an increased risk for hypertension and arterial disease but not arrhythmias, heart failure, ischemic heart disease, thromboembolic disease, or cerebrovascular disease.

For hypertension, the adjusted odds ratio was 1.72 (95% confidence interval, 1.51-1.97) for 3 to ≤ 5 years and 1.80 (95% CI, 1.55-2.08) for > 5 years of medication use. For arterial disease, the AOR was 1.65 (95% CI, 1.11-2.45) for 3 to ≤ 5 years and 1.49 (95% CI, 0.96-2.32) for > 5 years of use.
 

Stimulants confer greatest risk

Across the 14-year follow-up period, each additional year of ADHD medication use was associated with an average 4% increased CVD risk, with a larger 8% increased risk in the first 3 years of cumulative use, followed by stable risk over the remaining follow-up.

Similar risks were observed in children and adults, as well as in females and males.

When focusing on specific ADHD medications, compared with no use, long-term use of the stimulant methylphenidate was associated with an increased risk for CVD (AOR, 1.20 [95% CI, 1.10-1.31] for 3 to ≤ 5 years and 1.19 [95% CI, 1.08-1.31] for > 5 years).

The same was true for long-term use of the stimulant lisdexamfetamine (AOR, 1.23 [95% CI, 1.05-1.44] for 2 to ≤ 3 years and 1.17 [95% CI, 0.98-1.40] for > 3 years).

In contrast, use of the nonstimulant atomoxetine was associated with elevated CVD risk only for the first year of use (AOR, 1.07; 95% CI, 1.01-1.13).

The increased risk for CVD occurred only above certain average daily doses: 45 mg for methylphenidate and lisdexamfetamine, 22.5 mg for amphetamines, and 120 mg for atomoxetine.

The authors note that, although they accounted for a wide range of potential confounding variables, considering the observational nature of the study and the possibility of residual confounding, they could not prove causality.

‘Tricky trade-offs’

The coauthors of an editorial in JAMA Psychiatry (2023 Nov 22. doi: 10.1001/jamapsychiatry.2023.4126) note that the study “should remind us that clinical decision-making is often based on tricky trade-offs that should be considered at the individual patient level.”

Given that hypertension is the leading cause of CV morbidity and mortality worldwide, the increased likelihood of hypertension with long-term use of ADHD medications “cannot be disregarded,” write Samuele Cortese, MD, PhD, and Cristiano Fava, MD, PhD, with University of Southampton (England).

“These findings are especially relevant given the reported association between ADHD and physical conditions, such as obesity, which further contribute to increased cardiovascular risk,” they add.

Dr. Cortese and Dr. Fava say that the increased CV risk – averaging 4% per year and stabilizing after 3 years of treatment – “should be carefully weighed against the established benefits, on a case-by-case basis.”

“Importantly,” they write, “large real-world self-controlled studies have shown that individuals with ADHD experience significantly fewer unintentional physical injuries, motor vehicle crashes, substance use disorders, and criminal acts, as well as improved academic functioning, during periods when they are taking, compared with periods when they are not taking, methylphenidate.”

The risk-benefit ratio, however, may be lower in people with preexisting heart conditions. However, more evidence and precise recommendations are needed in relation to the treatment of individuals with ADHD and preexisting CV conditions, the editorial writers say.

This study was supported by grants from the Swedish Research Council for Health, Working Life, and Welfare and the European Union’s Horizon 2020 research and innovation program. The authors and editorial writers have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Longer cumulative use of medication to treat attention-deficit/hyperactivity disorder (ADHD) is associated with a small, but statistically significant, increased risk for cardiovascular disease (CVD), results of a large Swedish nested case-control study suggest.

The increased risk was evident only for hypertension and arterial disease, was dose dependent, and was higher for stimulant than nonstimulant ADHD medications.

“Clinicians should be vigilant in monitoring signs and symptoms of cardiovascular diseases, particularly among those receiving higher doses,” Zheng Chang, PhD, principal researcher, department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, said in an interview.

“Treatment decisions, as always, should be based on careful weighing of potential benefits and risks at individual patient level, rather than simple one-size-fits-all recommendations,” Dr. Chang added.

The study was published online in JAMA Psychiatry

Filling in the research gaps

The use of medications to treat ADHD has increased markedly over the past decades in both children and adults. The potential risk for CVD associated with long-term ADHD medication use remains unclear. Most “longitudinal” studies that have looked at the association have an average follow-up time of no more than 2 years, the authors note.

In contrast, the Swedish study assessed the association between cumulative use of ADHD medication in children and adults followed for up to 14 years and also looked at whether associations differ across types of medication and dosages, types of CVD, gender, and age.

Among 278,027 individuals aged 6-64 years diagnosed with ADHD or dispensed ADHD medication, 10,388 with CVD were identified and matched to 51,672 controls without CVD.

Longer cumulative duration of ADHD medication use was associated with a statistically significant increased risk for CVD, compared with no use.

When the risk for specific CVDs was examined, long-term use of ADHD medication (compared with no use) was associated with an increased risk for hypertension and arterial disease but not arrhythmias, heart failure, ischemic heart disease, thromboembolic disease, or cerebrovascular disease.

For hypertension, the adjusted odds ratio was 1.72 (95% confidence interval, 1.51-1.97) for 3 to ≤ 5 years and 1.80 (95% CI, 1.55-2.08) for > 5 years of medication use. For arterial disease, the AOR was 1.65 (95% CI, 1.11-2.45) for 3 to ≤ 5 years and 1.49 (95% CI, 0.96-2.32) for > 5 years of use.
 

Stimulants confer greatest risk

Across the 14-year follow-up period, each additional year of ADHD medication use was associated with an average 4% increased CVD risk, with a larger 8% increased risk in the first 3 years of cumulative use, followed by stable risk over the remaining follow-up.

Similar risks were observed in children and adults, as well as in females and males.

When focusing on specific ADHD medications, compared with no use, long-term use of the stimulant methylphenidate was associated with an increased risk for CVD (AOR, 1.20 [95% CI, 1.10-1.31] for 3 to ≤ 5 years and 1.19 [95% CI, 1.08-1.31] for > 5 years).

The same was true for long-term use of the stimulant lisdexamfetamine (AOR, 1.23 [95% CI, 1.05-1.44] for 2 to ≤ 3 years and 1.17 [95% CI, 0.98-1.40] for > 3 years).

In contrast, use of the nonstimulant atomoxetine was associated with elevated CVD risk only for the first year of use (AOR, 1.07; 95% CI, 1.01-1.13).

The increased risk for CVD occurred only above certain average daily doses: 45 mg for methylphenidate and lisdexamfetamine, 22.5 mg for amphetamines, and 120 mg for atomoxetine.

The authors note that, although they accounted for a wide range of potential confounding variables, considering the observational nature of the study and the possibility of residual confounding, they could not prove causality.

‘Tricky trade-offs’

The coauthors of an editorial in JAMA Psychiatry (2023 Nov 22. doi: 10.1001/jamapsychiatry.2023.4126) note that the study “should remind us that clinical decision-making is often based on tricky trade-offs that should be considered at the individual patient level.”

Given that hypertension is the leading cause of CV morbidity and mortality worldwide, the increased likelihood of hypertension with long-term use of ADHD medications “cannot be disregarded,” write Samuele Cortese, MD, PhD, and Cristiano Fava, MD, PhD, with University of Southampton (England).

“These findings are especially relevant given the reported association between ADHD and physical conditions, such as obesity, which further contribute to increased cardiovascular risk,” they add.

Dr. Cortese and Dr. Fava say that the increased CV risk – averaging 4% per year and stabilizing after 3 years of treatment – “should be carefully weighed against the established benefits, on a case-by-case basis.”

“Importantly,” they write, “large real-world self-controlled studies have shown that individuals with ADHD experience significantly fewer unintentional physical injuries, motor vehicle crashes, substance use disorders, and criminal acts, as well as improved academic functioning, during periods when they are taking, compared with periods when they are not taking, methylphenidate.”

The risk-benefit ratio, however, may be lower in people with preexisting heart conditions. However, more evidence and precise recommendations are needed in relation to the treatment of individuals with ADHD and preexisting CV conditions, the editorial writers say.

This study was supported by grants from the Swedish Research Council for Health, Working Life, and Welfare and the European Union’s Horizon 2020 research and innovation program. The authors and editorial writers have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

BERLIN – Tapinarof cream is highly effective, safe, and well tolerated for the treatment of atopic dermatitis (AD) in adults as well as children as young as 2 years of age, according to results of two pivotal trials presented at the at the annual congress of the European Academy of Dermatology and Venereology.

If approved for AD, one advantage of tapinarof cream relative to topical corticosteroids is potential use “without restrictions on duration, extent, or site of application,” reported Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research, George Washington University, Washington.

Tapinarof cream, 1%, an aryl hydrocarbon receptor agonist, was approved in 2022 for treating plaque psoriasis in adults.

In the two phase 3 trials, ADORING 1 and ADORING 2, which were presented together at the meeting, the primary endpoint was Validated Investigator Global Assessment (vIGA) for AD of 0 (clear) or 1 (almost clear) at 8 weeks. For this endpoint and all secondary endpoints, the relative advantage of the active cream over the vehicle alone was about the same in both studies.

For example, the vIGA clear or almost clear response was met by 45.4% and 46.4% of those in the experimental arm of ADORING 1 and 2, respectively, but only 13.9% and 18.0% in the control arms (P < .0001 for both).

For the secondary endpoint of Eczema Area and Severity Index (EASI75), signifying 75% clearance of skin lesions, the response rates were 55.8% and 59.1% in the two trials, but only 22.9% and 24.1% in the respective control arms (P < .0001 for both).

The two identically designed trials randomized patients with moderate to severe AD in a 2:1 ratio to tapinarof cream or vehicle alone. There were 407 patients ages 2-81 years in ADORING I and 406 in ADORING 2. Patients were instructed to apply the active cream or vehicle once per day.

The safety data for tapinarof in these studies was generally consistent with the experience with this agent in plaque psoriasis. According to Dr. Silverberg, there was a modest increase in reports of headache early in this study, but these were transient. Follicular events were also more common on tapinarof than on its vehicle, but Dr. Silverberg said that the rate of discontinuations for adverse events, although low in both arms, was numerically lower in the active treatment arm in both trials.

“There were reports of contact dermatitis in the psoriasis studies, but we have not seen this in the AD trials,” Dr. Silverberg said.
 

Itch control evaluated

In a separate presentation of ADORING 1 and 2 results, Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland, provided detailed information about itch control, which was evaluated with the Peak Pruritus–Numerical Rating Scale (PP-NRS).

Ted Bosworth/MDedge News

“The PP-NRS considers a person’s worst itch over the past 24 hours based on an 11-point scale,” explained Dr. Simpson, who said that patients scored itch daily with comparisons made at weeks 1, 2, 4, and 8.

Over time, pruritus scores fell in both groups, but reductions were far steeper among those in the active treatment arms.

“In ADORING 1, there were greater reductions in itch as early as day 1,” Dr. Simpson reported. Although the differences in itch were not detected until day 2 in ADORING 2, the differences were already significant and clinically meaningful in both studies by the end of the first week.

By week 8, the mean reductions in PP-NRS scores were 2.6 and 2.4 in the vehicle arms of ADORING 1 and 2, respectively. In the treatment arm, the reduction was 4.1 points in both arms (P < .0001 for both studies).
 

Forty-eight–week follow-up planned

More than 90% of patients in both studies have rolled over into the open-label extension ADORING 3 trial, with a planned follow-up of 48 weeks, according to Dr. Silverberg, who said that those in the placebo arm have been crossed over to tapinarof.

The response and the safety appear to be similar in adults and children, although Dr. Silverberg said that further analyses of outcomes by age are planned. He noted that there is also an ongoing study of tapinarof in children with plaque psoriasis.

In AD in particular, Dr. Silverberg said there is “an unmet need” for a topical nonsteroidal anti-inflammatory. While topical corticosteroids are a mainstay of AD therapy in children as well as adults, he noted the limitations of these drugs, including that they can only be applied for limited periods.

Tapinarof binds to the aryl hydrocarbon receptor (AhR), which regulates immune function in the skin and is expressed in many skin cell types. By inhibiting AhR, tapinarof blocks cytokine activation and has an antioxidant effect.

Adelaide A. Hebert, MD, professor and director of pediatric dermatology, McGovern Medical School at UTHealth, Houston, has participated in clinical studies of tapinarof for AD, and said she has been impressed with its efficacy and tolerability in children as well as adults. In the case of children, parents, as well as patients, “valued the rapid onset of disease control, the once-daily application regimen, and the itch control,” she said in an interview after the meeting.

If approved, Dr. Hebert said, “this novel steroid-free medication has the potential to change the management arena for pediatric and adult patients with moderate to severe atopic dermatitis.”

The recent introduction of new systemic therapies for AD, such as JAK inhibitors, has increased options for AD control, but “we still need effective and safe topical therapies, especially in children and young adults,” said Sonja Ständer, MD, head of the Interdisciplinary Center for Chronic Pruritus, University of Münster (Germany). Author of a comprehensive review article on AD in the New England Journal of Medicine 2 years ago, Dr. Ständer said results from the phase 3 topical tapinarof trials, as well as the phase 3 topical ruxolitinib trials, which were also presented as late breakers at the 2023 EADV meeting, provide “hope that an alternative to topical steroids will soon be available.”

Based on their safety and rapid control of itch in children with AD, “these will complement our current portfolio of topical therapies very well and have the potential to replace topical steroids early in therapy or to replace them altogether,” she told this news organization.

Dermavant Sciences, manufacturer of tapinarof, anticipates filing for Food and Drug Administration approval for AD in the first quarter of 2024, according to a company statement.

Dr. Silverberg and Dr. Simpson reported financial relationships with multiple pharmaceutical companies, including Dermavant, which provided funding for the ADORING trials. Dr. Hebert has financial relationship with more than 15 pharmaceutical companies, including Dermavent and other companies that have or are developing therapies for AD. Dr. Ständer reported financial relationships with Beiersdorf, Eli Lilly, Galderma, Kiniksa, Pfizer, and Sanofi.

BERLIN – Tapinarof cream is highly effective, safe, and well tolerated for the treatment of atopic dermatitis (AD) in adults as well as children as young as 2 years of age, according to results of two pivotal trials presented at the at the annual congress of the European Academy of Dermatology and Venereology.

If approved for AD, one advantage of tapinarof cream relative to topical corticosteroids is potential use “without restrictions on duration, extent, or site of application,” reported Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research, George Washington University, Washington.

Tapinarof cream, 1%, an aryl hydrocarbon receptor agonist, was approved in 2022 for treating plaque psoriasis in adults.

In the two phase 3 trials, ADORING 1 and ADORING 2, which were presented together at the meeting, the primary endpoint was Validated Investigator Global Assessment (vIGA) for AD of 0 (clear) or 1 (almost clear) at 8 weeks. For this endpoint and all secondary endpoints, the relative advantage of the active cream over the vehicle alone was about the same in both studies.

For example, the vIGA clear or almost clear response was met by 45.4% and 46.4% of those in the experimental arm of ADORING 1 and 2, respectively, but only 13.9% and 18.0% in the control arms (P < .0001 for both).

For the secondary endpoint of Eczema Area and Severity Index (EASI75), signifying 75% clearance of skin lesions, the response rates were 55.8% and 59.1% in the two trials, but only 22.9% and 24.1% in the respective control arms (P < .0001 for both).

The two identically designed trials randomized patients with moderate to severe AD in a 2:1 ratio to tapinarof cream or vehicle alone. There were 407 patients ages 2-81 years in ADORING I and 406 in ADORING 2. Patients were instructed to apply the active cream or vehicle once per day.

The safety data for tapinarof in these studies was generally consistent with the experience with this agent in plaque psoriasis. According to Dr. Silverberg, there was a modest increase in reports of headache early in this study, but these were transient. Follicular events were also more common on tapinarof than on its vehicle, but Dr. Silverberg said that the rate of discontinuations for adverse events, although low in both arms, was numerically lower in the active treatment arm in both trials.

“There were reports of contact dermatitis in the psoriasis studies, but we have not seen this in the AD trials,” Dr. Silverberg said.
 

Itch control evaluated

In a separate presentation of ADORING 1 and 2 results, Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland, provided detailed information about itch control, which was evaluated with the Peak Pruritus–Numerical Rating Scale (PP-NRS).

Ted Bosworth/MDedge News

“The PP-NRS considers a person’s worst itch over the past 24 hours based on an 11-point scale,” explained Dr. Simpson, who said that patients scored itch daily with comparisons made at weeks 1, 2, 4, and 8.

Over time, pruritus scores fell in both groups, but reductions were far steeper among those in the active treatment arms.

“In ADORING 1, there were greater reductions in itch as early as day 1,” Dr. Simpson reported. Although the differences in itch were not detected until day 2 in ADORING 2, the differences were already significant and clinically meaningful in both studies by the end of the first week.

By week 8, the mean reductions in PP-NRS scores were 2.6 and 2.4 in the vehicle arms of ADORING 1 and 2, respectively. In the treatment arm, the reduction was 4.1 points in both arms (P < .0001 for both studies).
 

Forty-eight–week follow-up planned

More than 90% of patients in both studies have rolled over into the open-label extension ADORING 3 trial, with a planned follow-up of 48 weeks, according to Dr. Silverberg, who said that those in the placebo arm have been crossed over to tapinarof.

The response and the safety appear to be similar in adults and children, although Dr. Silverberg said that further analyses of outcomes by age are planned. He noted that there is also an ongoing study of tapinarof in children with plaque psoriasis.

In AD in particular, Dr. Silverberg said there is “an unmet need” for a topical nonsteroidal anti-inflammatory. While topical corticosteroids are a mainstay of AD therapy in children as well as adults, he noted the limitations of these drugs, including that they can only be applied for limited periods.

Tapinarof binds to the aryl hydrocarbon receptor (AhR), which regulates immune function in the skin and is expressed in many skin cell types. By inhibiting AhR, tapinarof blocks cytokine activation and has an antioxidant effect.

Adelaide A. Hebert, MD, professor and director of pediatric dermatology, McGovern Medical School at UTHealth, Houston, has participated in clinical studies of tapinarof for AD, and said she has been impressed with its efficacy and tolerability in children as well as adults. In the case of children, parents, as well as patients, “valued the rapid onset of disease control, the once-daily application regimen, and the itch control,” she said in an interview after the meeting.

If approved, Dr. Hebert said, “this novel steroid-free medication has the potential to change the management arena for pediatric and adult patients with moderate to severe atopic dermatitis.”

The recent introduction of new systemic therapies for AD, such as JAK inhibitors, has increased options for AD control, but “we still need effective and safe topical therapies, especially in children and young adults,” said Sonja Ständer, MD, head of the Interdisciplinary Center for Chronic Pruritus, University of Münster (Germany). Author of a comprehensive review article on AD in the New England Journal of Medicine 2 years ago, Dr. Ständer said results from the phase 3 topical tapinarof trials, as well as the phase 3 topical ruxolitinib trials, which were also presented as late breakers at the 2023 EADV meeting, provide “hope that an alternative to topical steroids will soon be available.”

Based on their safety and rapid control of itch in children with AD, “these will complement our current portfolio of topical therapies very well and have the potential to replace topical steroids early in therapy or to replace them altogether,” she told this news organization.

Dermavant Sciences, manufacturer of tapinarof, anticipates filing for Food and Drug Administration approval for AD in the first quarter of 2024, according to a company statement.

Dr. Silverberg and Dr. Simpson reported financial relationships with multiple pharmaceutical companies, including Dermavant, which provided funding for the ADORING trials. Dr. Hebert has financial relationship with more than 15 pharmaceutical companies, including Dermavent and other companies that have or are developing therapies for AD. Dr. Ständer reported financial relationships with Beiersdorf, Eli Lilly, Galderma, Kiniksa, Pfizer, and Sanofi.

BERLIN – Tapinarof cream is highly effective, safe, and well tolerated for the treatment of atopic dermatitis (AD) in adults as well as children as young as 2 years of age, according to results of two pivotal trials presented at the at the annual congress of the European Academy of Dermatology and Venereology.

If approved for AD, one advantage of tapinarof cream relative to topical corticosteroids is potential use “without restrictions on duration, extent, or site of application,” reported Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research, George Washington University, Washington.

Tapinarof cream, 1%, an aryl hydrocarbon receptor agonist, was approved in 2022 for treating plaque psoriasis in adults.

In the two phase 3 trials, ADORING 1 and ADORING 2, which were presented together at the meeting, the primary endpoint was Validated Investigator Global Assessment (vIGA) for AD of 0 (clear) or 1 (almost clear) at 8 weeks. For this endpoint and all secondary endpoints, the relative advantage of the active cream over the vehicle alone was about the same in both studies.

For example, the vIGA clear or almost clear response was met by 45.4% and 46.4% of those in the experimental arm of ADORING 1 and 2, respectively, but only 13.9% and 18.0% in the control arms (P < .0001 for both).

For the secondary endpoint of Eczema Area and Severity Index (EASI75), signifying 75% clearance of skin lesions, the response rates were 55.8% and 59.1% in the two trials, but only 22.9% and 24.1% in the respective control arms (P < .0001 for both).

The two identically designed trials randomized patients with moderate to severe AD in a 2:1 ratio to tapinarof cream or vehicle alone. There were 407 patients ages 2-81 years in ADORING I and 406 in ADORING 2. Patients were instructed to apply the active cream or vehicle once per day.

The safety data for tapinarof in these studies was generally consistent with the experience with this agent in plaque psoriasis. According to Dr. Silverberg, there was a modest increase in reports of headache early in this study, but these were transient. Follicular events were also more common on tapinarof than on its vehicle, but Dr. Silverberg said that the rate of discontinuations for adverse events, although low in both arms, was numerically lower in the active treatment arm in both trials.

“There were reports of contact dermatitis in the psoriasis studies, but we have not seen this in the AD trials,” Dr. Silverberg said.
 

Itch control evaluated

In a separate presentation of ADORING 1 and 2 results, Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland, provided detailed information about itch control, which was evaluated with the Peak Pruritus–Numerical Rating Scale (PP-NRS).

Ted Bosworth/MDedge News

“The PP-NRS considers a person’s worst itch over the past 24 hours based on an 11-point scale,” explained Dr. Simpson, who said that patients scored itch daily with comparisons made at weeks 1, 2, 4, and 8.

Over time, pruritus scores fell in both groups, but reductions were far steeper among those in the active treatment arms.

“In ADORING 1, there were greater reductions in itch as early as day 1,” Dr. Simpson reported. Although the differences in itch were not detected until day 2 in ADORING 2, the differences were already significant and clinically meaningful in both studies by the end of the first week.

By week 8, the mean reductions in PP-NRS scores were 2.6 and 2.4 in the vehicle arms of ADORING 1 and 2, respectively. In the treatment arm, the reduction was 4.1 points in both arms (P < .0001 for both studies).
 

Forty-eight–week follow-up planned

More than 90% of patients in both studies have rolled over into the open-label extension ADORING 3 trial, with a planned follow-up of 48 weeks, according to Dr. Silverberg, who said that those in the placebo arm have been crossed over to tapinarof.

The response and the safety appear to be similar in adults and children, although Dr. Silverberg said that further analyses of outcomes by age are planned. He noted that there is also an ongoing study of tapinarof in children with plaque psoriasis.

In AD in particular, Dr. Silverberg said there is “an unmet need” for a topical nonsteroidal anti-inflammatory. While topical corticosteroids are a mainstay of AD therapy in children as well as adults, he noted the limitations of these drugs, including that they can only be applied for limited periods.

Tapinarof binds to the aryl hydrocarbon receptor (AhR), which regulates immune function in the skin and is expressed in many skin cell types. By inhibiting AhR, tapinarof blocks cytokine activation and has an antioxidant effect.

Adelaide A. Hebert, MD, professor and director of pediatric dermatology, McGovern Medical School at UTHealth, Houston, has participated in clinical studies of tapinarof for AD, and said she has been impressed with its efficacy and tolerability in children as well as adults. In the case of children, parents, as well as patients, “valued the rapid onset of disease control, the once-daily application regimen, and the itch control,” she said in an interview after the meeting.

If approved, Dr. Hebert said, “this novel steroid-free medication has the potential to change the management arena for pediatric and adult patients with moderate to severe atopic dermatitis.”

The recent introduction of new systemic therapies for AD, such as JAK inhibitors, has increased options for AD control, but “we still need effective and safe topical therapies, especially in children and young adults,” said Sonja Ständer, MD, head of the Interdisciplinary Center for Chronic Pruritus, University of Münster (Germany). Author of a comprehensive review article on AD in the New England Journal of Medicine 2 years ago, Dr. Ständer said results from the phase 3 topical tapinarof trials, as well as the phase 3 topical ruxolitinib trials, which were also presented as late breakers at the 2023 EADV meeting, provide “hope that an alternative to topical steroids will soon be available.”

Based on their safety and rapid control of itch in children with AD, “these will complement our current portfolio of topical therapies very well and have the potential to replace topical steroids early in therapy or to replace them altogether,” she told this news organization.

Dermavant Sciences, manufacturer of tapinarof, anticipates filing for Food and Drug Administration approval for AD in the first quarter of 2024, according to a company statement.

Dr. Silverberg and Dr. Simpson reported financial relationships with multiple pharmaceutical companies, including Dermavant, which provided funding for the ADORING trials. Dr. Hebert has financial relationship with more than 15 pharmaceutical companies, including Dermavent and other companies that have or are developing therapies for AD. Dr. Ständer reported financial relationships with Beiersdorf, Eli Lilly, Galderma, Kiniksa, Pfizer, and Sanofi.

In April 2020, as many Americans prepared to spend the Easter holiday in lockdown, pop star Mariah Carey released a video honoring the “sacrifices and courage” of frontline workers battling COVID-19 – her 1993 hit, “Hero.”

“The sorrow that you know will melt away,” Ms. Carey sang. “When you feel like hope is gone,” the song continued, strength and answers can be found within, and “a hero lies in you.”

For health care professionals, the reality of 2020 wasn’t quite so uplifting. PPE shortages and spillover ICUs had many feeling helpless, exhausted, and overwhelmed. Few if any medical professionals felt their sorrows “melt away.”

We can’t expect depth and nuance from pop songs, but we can find in them the imagery that runs through our culture. The “hero narrative” – the idea that doctors, nurses, and others in health care have superhuman endurance and selflessness – has long been an undercurrent in the medical field.

And yet, without a workforce willing to perform without adequate sleep, food, or time off, the health care system couldn’t function, says Brian Park, MD, MPH, a family medicine physician at Oregon Health & Science University, Portland. At many academic health centers, for example, residents are “the bedrock of the workforce,” he explains. If they didn’t work 80-100 hours per week, those systems wouldn’t exist.

So, how do we look at the health care system in a way that is both grateful and critical, Dr. Park wonders. “How do we honor extreme acts of heroism and also acknowledge that the system sometimes gets by on the acts of heroes to patch up some of the brokenness and fragmentation within it?”

Put simply: What makes “heroism” necessary in the first place?
 

Heroes are determined

Ala Stanford, MD, a pediatric surgeon in Philadelphia, has frequently been called a “health care hero.” Given the title by CNN in 2021, she has received numerous other awards and accolades, featured in Fortune Magazine’s “World’s 50 Greatest Leaders” in 2021 and USA Today’s “Women of the Year” in 2022.

In 2020, Dr. Stanford was sheltering in place and watching “way too much” cable news. “They would play solemn music and show photos of all the people who had died,” she recalls. “I thought, ‘All these people are Black or brown. What is going on?’”

The standard explanation was that people of color were more vulnerable because they were more likely to be essential workers or have chronic health conditions. But Dr. Stanford believed this was only part of the story. The reason she saw that local Black communities had higher positivity rates was because people couldn’t get a COVID test.

Dr. Stanford got call after call from Philadelphians who had been turned away from testing centers. When she questioned colleagues, “they gave me every reason under the sun,” Dr. Stanford says. “It was because someone took public transportation, and they were only testing people in cars, or because they weren’t over 65, or because they didn’t have other comorbid health conditions, or because they weren’t a health care worker, or because they hadn’t traveled to China ...” The list went on.

Dr. Stanford appealed to local, state, and federal health authorities. Finally, she took matters into her own hands. She found tests, packed a van with masks, gowns, and gloves, and drove across the city going door to door. Eventually, she organized testing in the parking lots of Black churches, sometimes seeing more than 400 people per day.

The services were funded entirely through her own bank account and donations until she was eventually awarded a CDC grant through the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 and began to receive contracts from the city.

Since then, Dr. Stanford’s mission has evolved. She and her team provided COVID vaccinations to thousands, and in 2021, opened the Dr. Ala Stanford Center for Health Equity. The center offers primary care for all ages in underserved communities.

Still, Dr. Stanford doesn’t think of herself as a hero, and she stresses that many other people contributed to her success. “I think the world was on fire, and we were all firefighters,” Dr. Stanford says. “Someone said to me, ‘Ala, you ran to the fire and everyone else was running away from it, and you didn’t have to.’ … I feel like I was able to galvanize people to realize the power that they actually had. Maybe independently, they couldn’t do a whole lot, but collectively, we were a force.”
 

Heroes are selfless

Nicole Jackson, RN, an emergency room manager and nurse at Advocate Trinity Hospital in Chicago, was recently honored as a Health Care Hero by the American Red Cross of Greater Chicago.

On June 23, 2022, Jackson’s emergency department was understaffed and struggling with an influx of patients when three gunshot victims arrived. Two needed to be transferred to a trauma center, and one – with multiple gunshot wounds – required a critical care nurse in the ambulance. But the ETA for that transport was 90 minutes, which meant the patient might not survive. Although Ms. Jackson was already working beyond her shift, she rode in the ambulance with the patient herself and probably saved his life.

While this incident stood out to a colleague who nominated her for the Red Cross award, Ms. Jackson finds herself working extra hours fairly often. “Since COVID, that’s pretty much been like any other hospital,” she says. “We’ve had staffing challenges that we work through every day. So, the nurses come, they show up, and they do the best that they can with what we have to keep our patients safe.”

A 2022 survey by McKinsey estimated that by 2025, there could be a gap of 200,000 to 450,000 nurses in the United States. A two-year impact assessment from the American Nurses Foundation found that among more than 12,500 nurses, 40% were considering leaving their positions before the pandemic. By 2022, that number had jumped to 52% with the top reasons being insufficient staffing and negative effects on health and well-being.

Can the “hero narrative” help that situation? Ms. Jackson says she doesn’t see herself as a hero, but the supportive environment and gestures of recognition by staff do make her feel appreciated. These include daily messages offering “kudos” and nominations for the DAISY Award, which she herself received in 2022.

“I have people who I have encouraged to become nurses,” Ms. Jackson says, “and when they saw [the award], they were really excited about becoming a nurse.”
 

Heroes are strong

Jasmine Marcelin, MD, an infectious disease physician with Nebraska Medicine in Omaha, understands the need for heroes as symbols and sources of inspiration. Dr. Marcelin is a fan of the superhero movie genre. There is value, she says, in feeling hope and excitement while watching Superman or Wonder Woman save the day. Who doesn’t want to believe (if only briefly) that the good guys will always win?

In reality, Dr. Marcelin says, “none of us are invincible.” And it’s dangerous to forget that “the people behind the symbols are also human.”

In 2021, Dr. Marcelin gave a TEDx talk entitled, “The Myth of the Health Care Hero.” In it she discussed the extreme physical and mental toll of the pandemic on health care workers and urged her audience to think less about extravagant praise and more about their personal responsibilities. “We don’t want or need to be called heroes,” Dr. Marcelin said. “Right now, our love language is action. We need your help, and we cannot save the world on our own.”

Dr. Marcelin also sees links between superhuman expectations and the high levels of burnout in the medical field.

“It’s a systemic issue,” she explains, “where it requires a revamping and revitalization of the entire psyche of health care to recognize that the people working within this profession are human. And the things that we think and feel and need are the same as anybody else.”
 

Heroes are self-sacrificing 


Well-being, burnout, and disengagement in health care has become a focus for Oregon Health & Science’s Dr. Park, who is also director of RELATE Lab, an organization that aims to make health care more human-centered and equitable through leadership training, research, and community organizing.

For him, hearing neighbors banging pots and pans during the early pandemic was complicated. “The first phase for me was, ‘Thank you. I feel seen. I feel appreciated,’ ” he says. “Yes, I’m wearing a mask. I’m going in. I’m changing in the garage when I come home, so my kid and my partner don’t get sick.”

But after a while, the cheers started to feel like pressure. “Have I done anything heroic today?” Dr. Park asked himself. “Have I been as heroic as my friend who is in the hospital in the ICU? I don’t deserve this, so don’t bang those pots and pans for me.”

When your identity becomes about being a hero, Dr. Park says, when that becomes the standard by which you measure yourself, the result is often a sense of shame.

“I think a lot of people feel ashamed that they feel burnout,” he says, “because they’re supposed to be heroes, putting on their capes and masks. They’re waking up and saying, ‘I’m exhausted, and I can’t play that part today. But I know that’s the social expectation of me.’ “
 

Heroes are noble

There may not be a clear solution, but for many health care professionals, symbolic gestures alone are inadequate and, in certain cases, insulting.

On Doctor’s Day 2023, Alok Patel, MD, a pediatric hospitalist, tweeted a photo of an appreciation “gift” for staff from an unnamed hospital. The small items had metaphorical meanings – a rubber band “as a reminder to stay flexible,” a quarter “as a reminder to ‘call’ for help,” etc.

“Welcome to how you give thanks to ‘health care heroes,’ ” Dr. Patel tweeted.

For Dr. Patel, the issue is not lavish gifts but a need for an attitude shift. He recalls colleagues who felt ashamed asking for mental health services or time off, “because they were bombarded by the hero narrative, by the manufactured pressure that they needed to put their jobs above their own health – because that’s what ‘heroes’ do. I’m willing to bet most physicians would rather receive a sincere email with a transparent plan to better support health care workers than any Doctor’s Day gift,” he says.

In Dr. Marcelin’s TEDx talk, she quotes Spider-Man’s classic adage, “With great power, comes great responsibility.” She argues that this motto doesn’t just apply to those who can fly or deflect bullets; that’s not what heroism is. In fact, most people have their own definition of the word.

For Dr. Stanford, a hero is “someone who is selfless, putting the needs of others before their own.” Dr. Park believes there are no individual heroes. “It’s the work of the collective that’s truly heroic.”

By those standards, clearly anyone can step up, offer help, act with courage and kindness, and be heroic. “We humans, as ordinary as we are, can be extraordinary by using our power to do what’s right,” Dr. Marcelin says, “because there’s no such thing as health care heroes, just good people doing the right thing.”

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

In April 2020, as many Americans prepared to spend the Easter holiday in lockdown, pop star Mariah Carey released a video honoring the “sacrifices and courage” of frontline workers battling COVID-19 – her 1993 hit, “Hero.”

“The sorrow that you know will melt away,” Ms. Carey sang. “When you feel like hope is gone,” the song continued, strength and answers can be found within, and “a hero lies in you.”

For health care professionals, the reality of 2020 wasn’t quite so uplifting. PPE shortages and spillover ICUs had many feeling helpless, exhausted, and overwhelmed. Few if any medical professionals felt their sorrows “melt away.”

We can’t expect depth and nuance from pop songs, but we can find in them the imagery that runs through our culture. The “hero narrative” – the idea that doctors, nurses, and others in health care have superhuman endurance and selflessness – has long been an undercurrent in the medical field.

And yet, without a workforce willing to perform without adequate sleep, food, or time off, the health care system couldn’t function, says Brian Park, MD, MPH, a family medicine physician at Oregon Health & Science University, Portland. At many academic health centers, for example, residents are “the bedrock of the workforce,” he explains. If they didn’t work 80-100 hours per week, those systems wouldn’t exist.

So, how do we look at the health care system in a way that is both grateful and critical, Dr. Park wonders. “How do we honor extreme acts of heroism and also acknowledge that the system sometimes gets by on the acts of heroes to patch up some of the brokenness and fragmentation within it?”

Put simply: What makes “heroism” necessary in the first place?
 

Heroes are determined

Ala Stanford, MD, a pediatric surgeon in Philadelphia, has frequently been called a “health care hero.” Given the title by CNN in 2021, she has received numerous other awards and accolades, featured in Fortune Magazine’s “World’s 50 Greatest Leaders” in 2021 and USA Today’s “Women of the Year” in 2022.

In 2020, Dr. Stanford was sheltering in place and watching “way too much” cable news. “They would play solemn music and show photos of all the people who had died,” she recalls. “I thought, ‘All these people are Black or brown. What is going on?’”

The standard explanation was that people of color were more vulnerable because they were more likely to be essential workers or have chronic health conditions. But Dr. Stanford believed this was only part of the story. The reason she saw that local Black communities had higher positivity rates was because people couldn’t get a COVID test.

Dr. Stanford got call after call from Philadelphians who had been turned away from testing centers. When she questioned colleagues, “they gave me every reason under the sun,” Dr. Stanford says. “It was because someone took public transportation, and they were only testing people in cars, or because they weren’t over 65, or because they didn’t have other comorbid health conditions, or because they weren’t a health care worker, or because they hadn’t traveled to China ...” The list went on.

Dr. Stanford appealed to local, state, and federal health authorities. Finally, she took matters into her own hands. She found tests, packed a van with masks, gowns, and gloves, and drove across the city going door to door. Eventually, she organized testing in the parking lots of Black churches, sometimes seeing more than 400 people per day.

The services were funded entirely through her own bank account and donations until she was eventually awarded a CDC grant through the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 and began to receive contracts from the city.

Since then, Dr. Stanford’s mission has evolved. She and her team provided COVID vaccinations to thousands, and in 2021, opened the Dr. Ala Stanford Center for Health Equity. The center offers primary care for all ages in underserved communities.

Still, Dr. Stanford doesn’t think of herself as a hero, and she stresses that many other people contributed to her success. “I think the world was on fire, and we were all firefighters,” Dr. Stanford says. “Someone said to me, ‘Ala, you ran to the fire and everyone else was running away from it, and you didn’t have to.’ … I feel like I was able to galvanize people to realize the power that they actually had. Maybe independently, they couldn’t do a whole lot, but collectively, we were a force.”
 

Heroes are selfless

Nicole Jackson, RN, an emergency room manager and nurse at Advocate Trinity Hospital in Chicago, was recently honored as a Health Care Hero by the American Red Cross of Greater Chicago.

On June 23, 2022, Jackson’s emergency department was understaffed and struggling with an influx of patients when three gunshot victims arrived. Two needed to be transferred to a trauma center, and one – with multiple gunshot wounds – required a critical care nurse in the ambulance. But the ETA for that transport was 90 minutes, which meant the patient might not survive. Although Ms. Jackson was already working beyond her shift, she rode in the ambulance with the patient herself and probably saved his life.

While this incident stood out to a colleague who nominated her for the Red Cross award, Ms. Jackson finds herself working extra hours fairly often. “Since COVID, that’s pretty much been like any other hospital,” she says. “We’ve had staffing challenges that we work through every day. So, the nurses come, they show up, and they do the best that they can with what we have to keep our patients safe.”

A 2022 survey by McKinsey estimated that by 2025, there could be a gap of 200,000 to 450,000 nurses in the United States. A two-year impact assessment from the American Nurses Foundation found that among more than 12,500 nurses, 40% were considering leaving their positions before the pandemic. By 2022, that number had jumped to 52% with the top reasons being insufficient staffing and negative effects on health and well-being.

Can the “hero narrative” help that situation? Ms. Jackson says she doesn’t see herself as a hero, but the supportive environment and gestures of recognition by staff do make her feel appreciated. These include daily messages offering “kudos” and nominations for the DAISY Award, which she herself received in 2022.

“I have people who I have encouraged to become nurses,” Ms. Jackson says, “and when they saw [the award], they were really excited about becoming a nurse.”
 

Heroes are strong

Jasmine Marcelin, MD, an infectious disease physician with Nebraska Medicine in Omaha, understands the need for heroes as symbols and sources of inspiration. Dr. Marcelin is a fan of the superhero movie genre. There is value, she says, in feeling hope and excitement while watching Superman or Wonder Woman save the day. Who doesn’t want to believe (if only briefly) that the good guys will always win?

In reality, Dr. Marcelin says, “none of us are invincible.” And it’s dangerous to forget that “the people behind the symbols are also human.”

In 2021, Dr. Marcelin gave a TEDx talk entitled, “The Myth of the Health Care Hero.” In it she discussed the extreme physical and mental toll of the pandemic on health care workers and urged her audience to think less about extravagant praise and more about their personal responsibilities. “We don’t want or need to be called heroes,” Dr. Marcelin said. “Right now, our love language is action. We need your help, and we cannot save the world on our own.”

Dr. Marcelin also sees links between superhuman expectations and the high levels of burnout in the medical field.

“It’s a systemic issue,” she explains, “where it requires a revamping and revitalization of the entire psyche of health care to recognize that the people working within this profession are human. And the things that we think and feel and need are the same as anybody else.”
 

Heroes are self-sacrificing 


Well-being, burnout, and disengagement in health care has become a focus for Oregon Health & Science’s Dr. Park, who is also director of RELATE Lab, an organization that aims to make health care more human-centered and equitable through leadership training, research, and community organizing.

For him, hearing neighbors banging pots and pans during the early pandemic was complicated. “The first phase for me was, ‘Thank you. I feel seen. I feel appreciated,’ ” he says. “Yes, I’m wearing a mask. I’m going in. I’m changing in the garage when I come home, so my kid and my partner don’t get sick.”

But after a while, the cheers started to feel like pressure. “Have I done anything heroic today?” Dr. Park asked himself. “Have I been as heroic as my friend who is in the hospital in the ICU? I don’t deserve this, so don’t bang those pots and pans for me.”

When your identity becomes about being a hero, Dr. Park says, when that becomes the standard by which you measure yourself, the result is often a sense of shame.

“I think a lot of people feel ashamed that they feel burnout,” he says, “because they’re supposed to be heroes, putting on their capes and masks. They’re waking up and saying, ‘I’m exhausted, and I can’t play that part today. But I know that’s the social expectation of me.’ “
 

Heroes are noble

There may not be a clear solution, but for many health care professionals, symbolic gestures alone are inadequate and, in certain cases, insulting.

On Doctor’s Day 2023, Alok Patel, MD, a pediatric hospitalist, tweeted a photo of an appreciation “gift” for staff from an unnamed hospital. The small items had metaphorical meanings – a rubber band “as a reminder to stay flexible,” a quarter “as a reminder to ‘call’ for help,” etc.

“Welcome to how you give thanks to ‘health care heroes,’ ” Dr. Patel tweeted.

For Dr. Patel, the issue is not lavish gifts but a need for an attitude shift. He recalls colleagues who felt ashamed asking for mental health services or time off, “because they were bombarded by the hero narrative, by the manufactured pressure that they needed to put their jobs above their own health – because that’s what ‘heroes’ do. I’m willing to bet most physicians would rather receive a sincere email with a transparent plan to better support health care workers than any Doctor’s Day gift,” he says.

In Dr. Marcelin’s TEDx talk, she quotes Spider-Man’s classic adage, “With great power, comes great responsibility.” She argues that this motto doesn’t just apply to those who can fly or deflect bullets; that’s not what heroism is. In fact, most people have their own definition of the word.

For Dr. Stanford, a hero is “someone who is selfless, putting the needs of others before their own.” Dr. Park believes there are no individual heroes. “It’s the work of the collective that’s truly heroic.”

By those standards, clearly anyone can step up, offer help, act with courage and kindness, and be heroic. “We humans, as ordinary as we are, can be extraordinary by using our power to do what’s right,” Dr. Marcelin says, “because there’s no such thing as health care heroes, just good people doing the right thing.”

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

In April 2020, as many Americans prepared to spend the Easter holiday in lockdown, pop star Mariah Carey released a video honoring the “sacrifices and courage” of frontline workers battling COVID-19 – her 1993 hit, “Hero.”

“The sorrow that you know will melt away,” Ms. Carey sang. “When you feel like hope is gone,” the song continued, strength and answers can be found within, and “a hero lies in you.”

For health care professionals, the reality of 2020 wasn’t quite so uplifting. PPE shortages and spillover ICUs had many feeling helpless, exhausted, and overwhelmed. Few if any medical professionals felt their sorrows “melt away.”

We can’t expect depth and nuance from pop songs, but we can find in them the imagery that runs through our culture. The “hero narrative” – the idea that doctors, nurses, and others in health care have superhuman endurance and selflessness – has long been an undercurrent in the medical field.

And yet, without a workforce willing to perform without adequate sleep, food, or time off, the health care system couldn’t function, says Brian Park, MD, MPH, a family medicine physician at Oregon Health & Science University, Portland. At many academic health centers, for example, residents are “the bedrock of the workforce,” he explains. If they didn’t work 80-100 hours per week, those systems wouldn’t exist.

So, how do we look at the health care system in a way that is both grateful and critical, Dr. Park wonders. “How do we honor extreme acts of heroism and also acknowledge that the system sometimes gets by on the acts of heroes to patch up some of the brokenness and fragmentation within it?”

Put simply: What makes “heroism” necessary in the first place?
 

Heroes are determined

Ala Stanford, MD, a pediatric surgeon in Philadelphia, has frequently been called a “health care hero.” Given the title by CNN in 2021, she has received numerous other awards and accolades, featured in Fortune Magazine’s “World’s 50 Greatest Leaders” in 2021 and USA Today’s “Women of the Year” in 2022.

In 2020, Dr. Stanford was sheltering in place and watching “way too much” cable news. “They would play solemn music and show photos of all the people who had died,” she recalls. “I thought, ‘All these people are Black or brown. What is going on?’”

The standard explanation was that people of color were more vulnerable because they were more likely to be essential workers or have chronic health conditions. But Dr. Stanford believed this was only part of the story. The reason she saw that local Black communities had higher positivity rates was because people couldn’t get a COVID test.

Dr. Stanford got call after call from Philadelphians who had been turned away from testing centers. When she questioned colleagues, “they gave me every reason under the sun,” Dr. Stanford says. “It was because someone took public transportation, and they were only testing people in cars, or because they weren’t over 65, or because they didn’t have other comorbid health conditions, or because they weren’t a health care worker, or because they hadn’t traveled to China ...” The list went on.

Dr. Stanford appealed to local, state, and federal health authorities. Finally, she took matters into her own hands. She found tests, packed a van with masks, gowns, and gloves, and drove across the city going door to door. Eventually, she organized testing in the parking lots of Black churches, sometimes seeing more than 400 people per day.

The services were funded entirely through her own bank account and donations until she was eventually awarded a CDC grant through the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 and began to receive contracts from the city.

Since then, Dr. Stanford’s mission has evolved. She and her team provided COVID vaccinations to thousands, and in 2021, opened the Dr. Ala Stanford Center for Health Equity. The center offers primary care for all ages in underserved communities.

Still, Dr. Stanford doesn’t think of herself as a hero, and she stresses that many other people contributed to her success. “I think the world was on fire, and we were all firefighters,” Dr. Stanford says. “Someone said to me, ‘Ala, you ran to the fire and everyone else was running away from it, and you didn’t have to.’ … I feel like I was able to galvanize people to realize the power that they actually had. Maybe independently, they couldn’t do a whole lot, but collectively, we were a force.”
 

Heroes are selfless

Nicole Jackson, RN, an emergency room manager and nurse at Advocate Trinity Hospital in Chicago, was recently honored as a Health Care Hero by the American Red Cross of Greater Chicago.

On June 23, 2022, Jackson’s emergency department was understaffed and struggling with an influx of patients when three gunshot victims arrived. Two needed to be transferred to a trauma center, and one – with multiple gunshot wounds – required a critical care nurse in the ambulance. But the ETA for that transport was 90 minutes, which meant the patient might not survive. Although Ms. Jackson was already working beyond her shift, she rode in the ambulance with the patient herself and probably saved his life.

While this incident stood out to a colleague who nominated her for the Red Cross award, Ms. Jackson finds herself working extra hours fairly often. “Since COVID, that’s pretty much been like any other hospital,” she says. “We’ve had staffing challenges that we work through every day. So, the nurses come, they show up, and they do the best that they can with what we have to keep our patients safe.”

A 2022 survey by McKinsey estimated that by 2025, there could be a gap of 200,000 to 450,000 nurses in the United States. A two-year impact assessment from the American Nurses Foundation found that among more than 12,500 nurses, 40% were considering leaving their positions before the pandemic. By 2022, that number had jumped to 52% with the top reasons being insufficient staffing and negative effects on health and well-being.

Can the “hero narrative” help that situation? Ms. Jackson says she doesn’t see herself as a hero, but the supportive environment and gestures of recognition by staff do make her feel appreciated. These include daily messages offering “kudos” and nominations for the DAISY Award, which she herself received in 2022.

“I have people who I have encouraged to become nurses,” Ms. Jackson says, “and when they saw [the award], they were really excited about becoming a nurse.”
 

Heroes are strong

Jasmine Marcelin, MD, an infectious disease physician with Nebraska Medicine in Omaha, understands the need for heroes as symbols and sources of inspiration. Dr. Marcelin is a fan of the superhero movie genre. There is value, she says, in feeling hope and excitement while watching Superman or Wonder Woman save the day. Who doesn’t want to believe (if only briefly) that the good guys will always win?

In reality, Dr. Marcelin says, “none of us are invincible.” And it’s dangerous to forget that “the people behind the symbols are also human.”

In 2021, Dr. Marcelin gave a TEDx talk entitled, “The Myth of the Health Care Hero.” In it she discussed the extreme physical and mental toll of the pandemic on health care workers and urged her audience to think less about extravagant praise and more about their personal responsibilities. “We don’t want or need to be called heroes,” Dr. Marcelin said. “Right now, our love language is action. We need your help, and we cannot save the world on our own.”

Dr. Marcelin also sees links between superhuman expectations and the high levels of burnout in the medical field.

“It’s a systemic issue,” she explains, “where it requires a revamping and revitalization of the entire psyche of health care to recognize that the people working within this profession are human. And the things that we think and feel and need are the same as anybody else.”
 

Heroes are self-sacrificing 


Well-being, burnout, and disengagement in health care has become a focus for Oregon Health & Science’s Dr. Park, who is also director of RELATE Lab, an organization that aims to make health care more human-centered and equitable through leadership training, research, and community organizing.

For him, hearing neighbors banging pots and pans during the early pandemic was complicated. “The first phase for me was, ‘Thank you. I feel seen. I feel appreciated,’ ” he says. “Yes, I’m wearing a mask. I’m going in. I’m changing in the garage when I come home, so my kid and my partner don’t get sick.”

But after a while, the cheers started to feel like pressure. “Have I done anything heroic today?” Dr. Park asked himself. “Have I been as heroic as my friend who is in the hospital in the ICU? I don’t deserve this, so don’t bang those pots and pans for me.”

When your identity becomes about being a hero, Dr. Park says, when that becomes the standard by which you measure yourself, the result is often a sense of shame.

“I think a lot of people feel ashamed that they feel burnout,” he says, “because they’re supposed to be heroes, putting on their capes and masks. They’re waking up and saying, ‘I’m exhausted, and I can’t play that part today. But I know that’s the social expectation of me.’ “
 

Heroes are noble

There may not be a clear solution, but for many health care professionals, symbolic gestures alone are inadequate and, in certain cases, insulting.

On Doctor’s Day 2023, Alok Patel, MD, a pediatric hospitalist, tweeted a photo of an appreciation “gift” for staff from an unnamed hospital. The small items had metaphorical meanings – a rubber band “as a reminder to stay flexible,” a quarter “as a reminder to ‘call’ for help,” etc.

“Welcome to how you give thanks to ‘health care heroes,’ ” Dr. Patel tweeted.

For Dr. Patel, the issue is not lavish gifts but a need for an attitude shift. He recalls colleagues who felt ashamed asking for mental health services or time off, “because they were bombarded by the hero narrative, by the manufactured pressure that they needed to put their jobs above their own health – because that’s what ‘heroes’ do. I’m willing to bet most physicians would rather receive a sincere email with a transparent plan to better support health care workers than any Doctor’s Day gift,” he says.

In Dr. Marcelin’s TEDx talk, she quotes Spider-Man’s classic adage, “With great power, comes great responsibility.” She argues that this motto doesn’t just apply to those who can fly or deflect bullets; that’s not what heroism is. In fact, most people have their own definition of the word.

For Dr. Stanford, a hero is “someone who is selfless, putting the needs of others before their own.” Dr. Park believes there are no individual heroes. “It’s the work of the collective that’s truly heroic.”

By those standards, clearly anyone can step up, offer help, act with courage and kindness, and be heroic. “We humans, as ordinary as we are, can be extraordinary by using our power to do what’s right,” Dr. Marcelin says, “because there’s no such thing as health care heroes, just good people doing the right thing.”

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

The 2024 childhood and adolescent immunization schedule has been released and includes new recommendations for respiratory syncytial virus, mpox, COVID-19, influenza, pentavalent meningococcal, 20-valent pneumococcal, and poliovirus immunizations and vaccines.

The immunization schedule for children and adolescents, summarized as an American Academy of Pediatrics policy statement in the journal Pediatrics, contains new entries for the monoclonal antibody immunization nirsevimab for respiratory syncytial virus in infants, the maternal RSV vaccine RSVpreF for pregnant people, the mpox vaccine for adolescents, the 2023-2024 COVID-19 vaccine, the 20-valent pneumococcal conjugate vaccine (PCV20), and the pentavalent meningococcal vaccine (MenACWY-TT/MenB-FHbp).

A number of immunizations have been deleted from the 2024 schedule, including the pentavalent meningococcal vaccine MenABCWY because of a discontinuation in its distribution in the United States, the bivalent mRNA COVID-19 vaccines, the diphtheria and tetanus toxoids adsorbed vaccine, the 13-valent pneumococcal conjugate vaccine (PCV13), and the pneumococcal polysaccharide vaccine (PPSV23).

The 2024 childhood and adolescent immunization schedule, also approved by the Centers for Disease Control and Prevention, American Academy of Family Physicians, American College of Obstetricians and Gynecologists, American College of Nurse-Midwives, American Academy of Physician Associates, and National Association of Pediatric Nurse Practitioners, is published each year based on current recommendations that have been approved for use by the Food and Drug Administration.

In a press release, the AAP said the CDC decided to publish the recommendations early to ensure health providers are able to administer immunizations and that they are covered by insurance. They also referenced CDC reports that found vaccination rates for kindergarteners have not bounced back since the beginning of the COVID-19 pandemic, and vaccine exemptions for the 2022-2023 school year were at an “all-time high.”
 

RSV

New to the schedule are the recently approved RSV monoclonal antibody nirsevimab for infants and the RSV vaccine RSVpreF for pregnant people. According to the CDC’s combined immunization schedule for 2024, the timing of the infant RSV immunization is heavily dependent upon when and whether a RSV vaccine was administered during pregnancy. The RSV vaccine should be routinely given between 32 weeks and 36 weeks of gestation between September and January in most of the United States with the caveat that either the maternal vaccine or the infant immunization is recommended.

Infants born between October and March in most of the United States are eligible for the RSV immunization within 14 days of birth if the pregnant parent did not receive an RSV vaccine during pregnancy, or if the parent received the vaccine in the 14 days prior to birth. For infants born between April and September RSV immunization is recommended prior to the start of RSV season.

The immunization is also recommended for infants who were hospitalized for conditions such as prematurity after birth between October and March, infants aged 8-19 months who are undergoing medical support related to prematurity, infants aged 8-19 months who are severely immunocompromised, and infants aged 9-19 months who are American Indian or Alaska Native, and infants undergoing cardiac surgery with cardiopulmonary bypass.
 

Mpox

Another new addition to the schedule is mpox, which is recommended for adolescents 18 years or older who are at risk for mpox infection, including gay, bisexual, nonbinary, transgender, or other individuals who have developed a sexually transmitted disease within the last 6 months, had more than one sexual partner, or engaged in sex in a commercial sex venue or public space with confirmed mpox transmission.

Currently, mpox vaccination during pregnancy is not recommended due to a lack of safety data on the vaccine during pregnancy; however, the CDC noted pregnant persons who have been exposed to any of the risk factors above may receive the vaccine.
 

COVID, influenza, pneumococcal vaccines

The COVID-19 vaccine recommendations were updated to reflect the 2023-2023 formulation of the vaccine. Unvaccinated children between 6 months and 4 years of age will now receive the 2023-2024 formula mRNA vaccines, which includes the two-dose Moderna vaccine and three-dose Pfizer vaccine for use in that age group. Children with a previous history of COVID-19 vaccination are eligible to receive an age-appropriate COVID-19 vaccine from the 2023-2024 formulation, and children between 5-11 years old and 12-18 years old can receive a single dose of an mRNA vaccine regardless of vaccine history; unvaccinated children 12-18 years old are also eligible to receive the two-dose Novavax vaccine.

For influenza, the schedule refers to the Advisory Committee on Immunization Practices recommendations released in August, with a note indicating that individuals with an egg allergy can receive another vaccine recommended for their age group without concerns for safety.

The pneumococcal vaccine recommendations have removed PCV13 completely, with updates on the PCV15, PCV20, and PPSV23 in sections on routine vaccination, catch-up vaccination, and special situations. The poliovirus section has also seen its catch-up section revised with a recommendation to complete a vaccination series in adolescents 18 years old known or suspected to have an incomplete series, and to count trivalent oral poliovirus vaccines and OPV administered before April 2016 toward U.S. vaccination requirements.
 

‘Timely and necessary’ changes

Michael Pichichero, MD, director of the Rochester (N.Y.) General Hospital Research Institute, said in an interview that the committee that developed the immunization schedule was thorough in its recommendations for children and adolescents.

“The additions are timely and necessary as the landscape of vaccines for children changes,” he said.

Bonnie M. Word, MD, director of the Houston Travel Medicine Clinic, said that the immunization schedule “sets the standard and provides clarification and uniformity for administration of all recommended vaccines for U.S. children.”

The U.S. immunization program “is one of the best success stories in medicine,” Dr. Wood said. She noted it is important for providers to become familiar with these vaccines and their indications “to provide advice and be able to respond to questions of parents and/or patients.

“Often patients spend more time with office staff than the physician. It is helpful to make sure everyone in the office understands the importance of and the rationale for immunizing, so families hear consistent messaging,” she said.

Dr. Pichichero and Dr. Word reported no relevant conflicts of interest.

The 2024 childhood and adolescent immunization schedule has been released and includes new recommendations for respiratory syncytial virus, mpox, COVID-19, influenza, pentavalent meningococcal, 20-valent pneumococcal, and poliovirus immunizations and vaccines.

The immunization schedule for children and adolescents, summarized as an American Academy of Pediatrics policy statement in the journal Pediatrics, contains new entries for the monoclonal antibody immunization nirsevimab for respiratory syncytial virus in infants, the maternal RSV vaccine RSVpreF for pregnant people, the mpox vaccine for adolescents, the 2023-2024 COVID-19 vaccine, the 20-valent pneumococcal conjugate vaccine (PCV20), and the pentavalent meningococcal vaccine (MenACWY-TT/MenB-FHbp).

A number of immunizations have been deleted from the 2024 schedule, including the pentavalent meningococcal vaccine MenABCWY because of a discontinuation in its distribution in the United States, the bivalent mRNA COVID-19 vaccines, the diphtheria and tetanus toxoids adsorbed vaccine, the 13-valent pneumococcal conjugate vaccine (PCV13), and the pneumococcal polysaccharide vaccine (PPSV23).

The 2024 childhood and adolescent immunization schedule, also approved by the Centers for Disease Control and Prevention, American Academy of Family Physicians, American College of Obstetricians and Gynecologists, American College of Nurse-Midwives, American Academy of Physician Associates, and National Association of Pediatric Nurse Practitioners, is published each year based on current recommendations that have been approved for use by the Food and Drug Administration.

In a press release, the AAP said the CDC decided to publish the recommendations early to ensure health providers are able to administer immunizations and that they are covered by insurance. They also referenced CDC reports that found vaccination rates for kindergarteners have not bounced back since the beginning of the COVID-19 pandemic, and vaccine exemptions for the 2022-2023 school year were at an “all-time high.”
 

RSV

New to the schedule are the recently approved RSV monoclonal antibody nirsevimab for infants and the RSV vaccine RSVpreF for pregnant people. According to the CDC’s combined immunization schedule for 2024, the timing of the infant RSV immunization is heavily dependent upon when and whether a RSV vaccine was administered during pregnancy. The RSV vaccine should be routinely given between 32 weeks and 36 weeks of gestation between September and January in most of the United States with the caveat that either the maternal vaccine or the infant immunization is recommended.

Infants born between October and March in most of the United States are eligible for the RSV immunization within 14 days of birth if the pregnant parent did not receive an RSV vaccine during pregnancy, or if the parent received the vaccine in the 14 days prior to birth. For infants born between April and September RSV immunization is recommended prior to the start of RSV season.

The immunization is also recommended for infants who were hospitalized for conditions such as prematurity after birth between October and March, infants aged 8-19 months who are undergoing medical support related to prematurity, infants aged 8-19 months who are severely immunocompromised, and infants aged 9-19 months who are American Indian or Alaska Native, and infants undergoing cardiac surgery with cardiopulmonary bypass.
 

Mpox

Another new addition to the schedule is mpox, which is recommended for adolescents 18 years or older who are at risk for mpox infection, including gay, bisexual, nonbinary, transgender, or other individuals who have developed a sexually transmitted disease within the last 6 months, had more than one sexual partner, or engaged in sex in a commercial sex venue or public space with confirmed mpox transmission.

Currently, mpox vaccination during pregnancy is not recommended due to a lack of safety data on the vaccine during pregnancy; however, the CDC noted pregnant persons who have been exposed to any of the risk factors above may receive the vaccine.
 

COVID, influenza, pneumococcal vaccines

The COVID-19 vaccine recommendations were updated to reflect the 2023-2023 formulation of the vaccine. Unvaccinated children between 6 months and 4 years of age will now receive the 2023-2024 formula mRNA vaccines, which includes the two-dose Moderna vaccine and three-dose Pfizer vaccine for use in that age group. Children with a previous history of COVID-19 vaccination are eligible to receive an age-appropriate COVID-19 vaccine from the 2023-2024 formulation, and children between 5-11 years old and 12-18 years old can receive a single dose of an mRNA vaccine regardless of vaccine history; unvaccinated children 12-18 years old are also eligible to receive the two-dose Novavax vaccine.

For influenza, the schedule refers to the Advisory Committee on Immunization Practices recommendations released in August, with a note indicating that individuals with an egg allergy can receive another vaccine recommended for their age group without concerns for safety.

The pneumococcal vaccine recommendations have removed PCV13 completely, with updates on the PCV15, PCV20, and PPSV23 in sections on routine vaccination, catch-up vaccination, and special situations. The poliovirus section has also seen its catch-up section revised with a recommendation to complete a vaccination series in adolescents 18 years old known or suspected to have an incomplete series, and to count trivalent oral poliovirus vaccines and OPV administered before April 2016 toward U.S. vaccination requirements.
 

‘Timely and necessary’ changes

Michael Pichichero, MD, director of the Rochester (N.Y.) General Hospital Research Institute, said in an interview that the committee that developed the immunization schedule was thorough in its recommendations for children and adolescents.

“The additions are timely and necessary as the landscape of vaccines for children changes,” he said.

Bonnie M. Word, MD, director of the Houston Travel Medicine Clinic, said that the immunization schedule “sets the standard and provides clarification and uniformity for administration of all recommended vaccines for U.S. children.”

The U.S. immunization program “is one of the best success stories in medicine,” Dr. Wood said. She noted it is important for providers to become familiar with these vaccines and their indications “to provide advice and be able to respond to questions of parents and/or patients.

“Often patients spend more time with office staff than the physician. It is helpful to make sure everyone in the office understands the importance of and the rationale for immunizing, so families hear consistent messaging,” she said.

Dr. Pichichero and Dr. Word reported no relevant conflicts of interest.

The 2024 childhood and adolescent immunization schedule has been released and includes new recommendations for respiratory syncytial virus, mpox, COVID-19, influenza, pentavalent meningococcal, 20-valent pneumococcal, and poliovirus immunizations and vaccines.

The immunization schedule for children and adolescents, summarized as an American Academy of Pediatrics policy statement in the journal Pediatrics, contains new entries for the monoclonal antibody immunization nirsevimab for respiratory syncytial virus in infants, the maternal RSV vaccine RSVpreF for pregnant people, the mpox vaccine for adolescents, the 2023-2024 COVID-19 vaccine, the 20-valent pneumococcal conjugate vaccine (PCV20), and the pentavalent meningococcal vaccine (MenACWY-TT/MenB-FHbp).

A number of immunizations have been deleted from the 2024 schedule, including the pentavalent meningococcal vaccine MenABCWY because of a discontinuation in its distribution in the United States, the bivalent mRNA COVID-19 vaccines, the diphtheria and tetanus toxoids adsorbed vaccine, the 13-valent pneumococcal conjugate vaccine (PCV13), and the pneumococcal polysaccharide vaccine (PPSV23).

The 2024 childhood and adolescent immunization schedule, also approved by the Centers for Disease Control and Prevention, American Academy of Family Physicians, American College of Obstetricians and Gynecologists, American College of Nurse-Midwives, American Academy of Physician Associates, and National Association of Pediatric Nurse Practitioners, is published each year based on current recommendations that have been approved for use by the Food and Drug Administration.

In a press release, the AAP said the CDC decided to publish the recommendations early to ensure health providers are able to administer immunizations and that they are covered by insurance. They also referenced CDC reports that found vaccination rates for kindergarteners have not bounced back since the beginning of the COVID-19 pandemic, and vaccine exemptions for the 2022-2023 school year were at an “all-time high.”
 

RSV

New to the schedule are the recently approved RSV monoclonal antibody nirsevimab for infants and the RSV vaccine RSVpreF for pregnant people. According to the CDC’s combined immunization schedule for 2024, the timing of the infant RSV immunization is heavily dependent upon when and whether a RSV vaccine was administered during pregnancy. The RSV vaccine should be routinely given between 32 weeks and 36 weeks of gestation between September and January in most of the United States with the caveat that either the maternal vaccine or the infant immunization is recommended.

Infants born between October and March in most of the United States are eligible for the RSV immunization within 14 days of birth if the pregnant parent did not receive an RSV vaccine during pregnancy, or if the parent received the vaccine in the 14 days prior to birth. For infants born between April and September RSV immunization is recommended prior to the start of RSV season.

The immunization is also recommended for infants who were hospitalized for conditions such as prematurity after birth between October and March, infants aged 8-19 months who are undergoing medical support related to prematurity, infants aged 8-19 months who are severely immunocompromised, and infants aged 9-19 months who are American Indian or Alaska Native, and infants undergoing cardiac surgery with cardiopulmonary bypass.
 

Mpox

Another new addition to the schedule is mpox, which is recommended for adolescents 18 years or older who are at risk for mpox infection, including gay, bisexual, nonbinary, transgender, or other individuals who have developed a sexually transmitted disease within the last 6 months, had more than one sexual partner, or engaged in sex in a commercial sex venue or public space with confirmed mpox transmission.

Currently, mpox vaccination during pregnancy is not recommended due to a lack of safety data on the vaccine during pregnancy; however, the CDC noted pregnant persons who have been exposed to any of the risk factors above may receive the vaccine.
 

COVID, influenza, pneumococcal vaccines

The COVID-19 vaccine recommendations were updated to reflect the 2023-2023 formulation of the vaccine. Unvaccinated children between 6 months and 4 years of age will now receive the 2023-2024 formula mRNA vaccines, which includes the two-dose Moderna vaccine and three-dose Pfizer vaccine for use in that age group. Children with a previous history of COVID-19 vaccination are eligible to receive an age-appropriate COVID-19 vaccine from the 2023-2024 formulation, and children between 5-11 years old and 12-18 years old can receive a single dose of an mRNA vaccine regardless of vaccine history; unvaccinated children 12-18 years old are also eligible to receive the two-dose Novavax vaccine.

For influenza, the schedule refers to the Advisory Committee on Immunization Practices recommendations released in August, with a note indicating that individuals with an egg allergy can receive another vaccine recommended for their age group without concerns for safety.

The pneumococcal vaccine recommendations have removed PCV13 completely, with updates on the PCV15, PCV20, and PPSV23 in sections on routine vaccination, catch-up vaccination, and special situations. The poliovirus section has also seen its catch-up section revised with a recommendation to complete a vaccination series in adolescents 18 years old known or suspected to have an incomplete series, and to count trivalent oral poliovirus vaccines and OPV administered before April 2016 toward U.S. vaccination requirements.
 

‘Timely and necessary’ changes

Michael Pichichero, MD, director of the Rochester (N.Y.) General Hospital Research Institute, said in an interview that the committee that developed the immunization schedule was thorough in its recommendations for children and adolescents.

“The additions are timely and necessary as the landscape of vaccines for children changes,” he said.

Bonnie M. Word, MD, director of the Houston Travel Medicine Clinic, said that the immunization schedule “sets the standard and provides clarification and uniformity for administration of all recommended vaccines for U.S. children.”

The U.S. immunization program “is one of the best success stories in medicine,” Dr. Wood said. She noted it is important for providers to become familiar with these vaccines and their indications “to provide advice and be able to respond to questions of parents and/or patients.

“Often patients spend more time with office staff than the physician. It is helpful to make sure everyone in the office understands the importance of and the rationale for immunizing, so families hear consistent messaging,” she said.

Dr. Pichichero and Dr. Word reported no relevant conflicts of interest.

I suspect that, like me, you were saddened, but maybe not shocked, to learn that firearm-related fatalities have recently surpassed motor vehicle–related fatalities as the leading cause of death among children. For those of us living in Maine, this revelation came at a particularly difficult time. The body of the presumed shooter in the Lewiston massacre was found less than 10 miles from where I am writing you this letter. There is a good chance he may have been a former patient of mine, but I no longer have access to my records to confirm that.

This reshuffling at the top of the list of mortality causes is just one example of the shifting trends that have occurred in pediatric fatality statistics. In a recent analysis of the Centers for Disease Control and Prevention statistics published in Pediatrics investigators discovered that while, in general, fatal injuries have increased over the study period (2011-2021) nonfatal injuries have decreased.

We should no longer be surprised to learn that firearm-related deaths increased more than 87%. Fatal drug poisoning was up 133% and suffocation-related deaths increased 12.5% over that 10-year period. Given this profile of fatalities, it shouldn’t surprise us that nonfatal injuries due to firearms, poisoning, and self-harm also increased.

However, nonfatal injuries in other broad categories decreased: falls were down 52.8%, overexertion 63%, struck by [something or someone] 47.3%, motor vehicle occupant 36.7%, and cut pierce 36.7%. Nonfatal drownings were unchanged.
 

Diverging trends

Fatal injuries are up and nonfatal injuries are down. What are we to make of these diverging trends? I suspect that when it comes to both firearms and drug poisonings, both fatal and nonfatal, children are now living in an environment in which the sheer volume of guns and drugs have grown the point, and will continue to grow, that contact and its consequences will continue to increase until we reach a saturation point at some unpredictable point in the future. There still may be some opportunities to curb the flow of drugs. But, I am afraid when it comes to firearms, that ship has sailed. We may have a chance to curb assault weapons, but hand guns have become ubiquitous to the point that they will continue to be a threat to children.

The increase in self-harm injuries is clearly a reflection of the increase in pediatric and adolescent mental health disturbances, which in turn is a reflection of the gloom hanging over the population in general.

But, what’s going on with the decrease in nonfatal injuries caused by falls, overexertion, struck by, and cut pierce? Is this a bit of sunshine in an otherwise cloudy picture? The authors of the paper see it as a reflection of our “public health interventions targeting pediatric safety partnered with technological advancement and legislative requirements.” Maybe when we are talking about booster seats and other automotive safety advancements. But I’m not so sure we should be too vigorous as we pat ourselves on the back.

On the other hand, aren’t these decreases in injuries related to activity just more evidence of our increasingly sedentary pediatric population? Falling off the couch seldom creates an injury that generates an ED statistic. Myopia and obesity related to excess screen time doesn’t trigger data points in this study. Overexertion injuries are down. We already know the consequences of underexertion are up.

I’m not sure we need to cut back on our efforts at injury prevention but I worry that we may run the risk of discouraging healthy activity if we aren’t careful with our voices of caution.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

I suspect that, like me, you were saddened, but maybe not shocked, to learn that firearm-related fatalities have recently surpassed motor vehicle–related fatalities as the leading cause of death among children. For those of us living in Maine, this revelation came at a particularly difficult time. The body of the presumed shooter in the Lewiston massacre was found less than 10 miles from where I am writing you this letter. There is a good chance he may have been a former patient of mine, but I no longer have access to my records to confirm that.

This reshuffling at the top of the list of mortality causes is just one example of the shifting trends that have occurred in pediatric fatality statistics. In a recent analysis of the Centers for Disease Control and Prevention statistics published in Pediatrics investigators discovered that while, in general, fatal injuries have increased over the study period (2011-2021) nonfatal injuries have decreased.

We should no longer be surprised to learn that firearm-related deaths increased more than 87%. Fatal drug poisoning was up 133% and suffocation-related deaths increased 12.5% over that 10-year period. Given this profile of fatalities, it shouldn’t surprise us that nonfatal injuries due to firearms, poisoning, and self-harm also increased.

However, nonfatal injuries in other broad categories decreased: falls were down 52.8%, overexertion 63%, struck by [something or someone] 47.3%, motor vehicle occupant 36.7%, and cut pierce 36.7%. Nonfatal drownings were unchanged.
 

Diverging trends

Fatal injuries are up and nonfatal injuries are down. What are we to make of these diverging trends? I suspect that when it comes to both firearms and drug poisonings, both fatal and nonfatal, children are now living in an environment in which the sheer volume of guns and drugs have grown the point, and will continue to grow, that contact and its consequences will continue to increase until we reach a saturation point at some unpredictable point in the future. There still may be some opportunities to curb the flow of drugs. But, I am afraid when it comes to firearms, that ship has sailed. We may have a chance to curb assault weapons, but hand guns have become ubiquitous to the point that they will continue to be a threat to children.

The increase in self-harm injuries is clearly a reflection of the increase in pediatric and adolescent mental health disturbances, which in turn is a reflection of the gloom hanging over the population in general.

But, what’s going on with the decrease in nonfatal injuries caused by falls, overexertion, struck by, and cut pierce? Is this a bit of sunshine in an otherwise cloudy picture? The authors of the paper see it as a reflection of our “public health interventions targeting pediatric safety partnered with technological advancement and legislative requirements.” Maybe when we are talking about booster seats and other automotive safety advancements. But I’m not so sure we should be too vigorous as we pat ourselves on the back.

On the other hand, aren’t these decreases in injuries related to activity just more evidence of our increasingly sedentary pediatric population? Falling off the couch seldom creates an injury that generates an ED statistic. Myopia and obesity related to excess screen time doesn’t trigger data points in this study. Overexertion injuries are down. We already know the consequences of underexertion are up.

I’m not sure we need to cut back on our efforts at injury prevention but I worry that we may run the risk of discouraging healthy activity if we aren’t careful with our voices of caution.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

I suspect that, like me, you were saddened, but maybe not shocked, to learn that firearm-related fatalities have recently surpassed motor vehicle–related fatalities as the leading cause of death among children. For those of us living in Maine, this revelation came at a particularly difficult time. The body of the presumed shooter in the Lewiston massacre was found less than 10 miles from where I am writing you this letter. There is a good chance he may have been a former patient of mine, but I no longer have access to my records to confirm that.

This reshuffling at the top of the list of mortality causes is just one example of the shifting trends that have occurred in pediatric fatality statistics. In a recent analysis of the Centers for Disease Control and Prevention statistics published in Pediatrics investigators discovered that while, in general, fatal injuries have increased over the study period (2011-2021) nonfatal injuries have decreased.

We should no longer be surprised to learn that firearm-related deaths increased more than 87%. Fatal drug poisoning was up 133% and suffocation-related deaths increased 12.5% over that 10-year period. Given this profile of fatalities, it shouldn’t surprise us that nonfatal injuries due to firearms, poisoning, and self-harm also increased.

However, nonfatal injuries in other broad categories decreased: falls were down 52.8%, overexertion 63%, struck by [something or someone] 47.3%, motor vehicle occupant 36.7%, and cut pierce 36.7%. Nonfatal drownings were unchanged.
 

Diverging trends

Fatal injuries are up and nonfatal injuries are down. What are we to make of these diverging trends? I suspect that when it comes to both firearms and drug poisonings, both fatal and nonfatal, children are now living in an environment in which the sheer volume of guns and drugs have grown the point, and will continue to grow, that contact and its consequences will continue to increase until we reach a saturation point at some unpredictable point in the future. There still may be some opportunities to curb the flow of drugs. But, I am afraid when it comes to firearms, that ship has sailed. We may have a chance to curb assault weapons, but hand guns have become ubiquitous to the point that they will continue to be a threat to children.

The increase in self-harm injuries is clearly a reflection of the increase in pediatric and adolescent mental health disturbances, which in turn is a reflection of the gloom hanging over the population in general.

But, what’s going on with the decrease in nonfatal injuries caused by falls, overexertion, struck by, and cut pierce? Is this a bit of sunshine in an otherwise cloudy picture? The authors of the paper see it as a reflection of our “public health interventions targeting pediatric safety partnered with technological advancement and legislative requirements.” Maybe when we are talking about booster seats and other automotive safety advancements. But I’m not so sure we should be too vigorous as we pat ourselves on the back.

On the other hand, aren’t these decreases in injuries related to activity just more evidence of our increasingly sedentary pediatric population? Falling off the couch seldom creates an injury that generates an ED statistic. Myopia and obesity related to excess screen time doesn’t trigger data points in this study. Overexertion injuries are down. We already know the consequences of underexertion are up.

I’m not sure we need to cut back on our efforts at injury prevention but I worry that we may run the risk of discouraging healthy activity if we aren’t careful with our voices of caution.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

NEW YORK – Many inflammatory diseases, such as psoriasis and atopic dermatitis (AD), can present differently in patients with darker skin types, but it is the pigmentary changes themselves that are often a dominant concern for parents, according to pediatric dermatologist Candrice R. Heath, MD.

Skin diseases pose a greater risk of both hyper- and hypopigmentation in patients with darker skin types, but the fear and concern that this raises for permanent disfigurement is not limited to Blacks, Dr. Heath, assistant professor of pediatric dermatology at Temple University, Philadelphia, said at the Skin of Color Update 2023.

“Culturally, pigmentation changes can be huge. For people of Indian descent, for example, pigmentary changes like light spots on the skin might be an obstacle to marriage, so it can really be life changing,” she added.

In patients with darker skin tones presenting with an inflammatory skin disease, such as AD or psoriasis, Dr. Heath advised asking specifically about change in skin tone even if it is not readily apparent. In pediatric patients, it is also appropriate to include parents in this conversation.
 

Consider the parent’s perspective

“When you are taking care of a child or adolescent, the patient is likely to be concerned about changes in pigmentation, but it is important to remember that the adult in the room might have had their own journey with brown skin and has dealt with the burden of pigment changes,” Dr. Heath said.

For the parent, the pigmentation changes, rather than the inflammation, might be the governing issue and the reason that he or she brought the child to the clinician. Dr. Heath suggested that it is important for caregivers to explicitly recognize their concern, explain that addressing the pigmentary changes is part of the treatment plan, and to create realistic expectations about how long pigmentary changes will take to resolve.

As an example, Dr. Heath recounted a difficult case of a Black infant with disseminated hyperpigmentation and features that did not preclude pathology other than AD. Dr. Heath created a multifaceted treatment plan to address the inflammation in distinct areas of the body that included low-strength topical steroids for the face, stronger steroids for the body, and advice on scalp and skin care.

“I thought this was a great treatment plan out of the gate – I was covering all of the things on my differential list – I thought that the mom would be thinking, this doctor is amazing,” Dr. Heath said.
 

Pigmentary changes are a priority

However, that was not what the patient’s mother was thinking. Having failed to explicitly recognize her concern about the pigmentation changes and how the treatment would address this issue, the mother was disappointed.

“She had one question: Will my baby ever be one color? That was her main concern,” said Dr. Heath, indicating that other clinicians seeing inflammatory diseases in children with darker skin types can learn from her experience.

“Really, you have to acknowledge that the condition you are treating is causing the pigmentation change, and we do see that and that we have a treatment plan in place,” she said.

Because of differences in how inflammatory skin diseases present in darker skin types, there is plenty of room for a delayed diagnosis for clinicians who do not see many of these patients, according to Dr. Heath. Follicular eczema, which is common in skin of color, often presents with pruritus but differences in the appearance of the underlying disease can threaten a delay in diagnosis.

In cases of follicular eczema with itch in darker skin, the bumps look and feel like goose bumps, which “means that the eczema is really active and inflamed,” Dr. Heath said. When the skin becomes smooth and the itch dissipates, “you know that they are under great control.”

Psoriasis is often missed in children with darker skin types based on the misperception that it is rare. Although it is true that it is less common in Blacks than Whites, it is not rare, according to Dr. Heath. In inspecting the telltale erythematous plaque–like lesions, clinicians might start to consider alternative diagnoses when they do not detect the same erythematous appearance, but the reddish tone is often concealed in darker skin.

She said that predominant involvement in the head and neck and diaper area is often more common in children of color and that nail or scalp involvement, when present, is often a clue that psoriasis is the diagnosis.

Again, because many clinicians do not think immediately of psoriasis in darker skin children with lesions in the scalp, Dr. Heath advised this is another reason to include psoriasis in the differential diagnosis.

“If you have a child that has failed multiple courses of treatment for tinea capitis and they have well-demarcated plaques, it’s time to really start to think about pediatric psoriasis,” she said.
 

Restoring skin tone can be the priority

Asked to comment on Dr. Heath’s advice about the importance of acknowledging pigmentary changes associated with inflammatory skin diseases in patients of color, Jenna Lester, MD, the founding director of the Skin of Color Clinic at the University of California, San Francisco, called it an “often unspoken concern of patients.”

“Pigmentary changes that occur secondary to an inflammatory condition should be addressed and treated alongside the inciting condition,” she agreed.

Even if changes in skin color or skin tone are not a specific complaint of the patients, Dr. Lester also urged clinicians to raise the topic. If change in skin pigmentation is part of the clinical picture, this should be targeted in the treatment plan.

“In acne, for example, often times I find that patients are as worried about postinflammatory hyperpigmentation as they are about their acne,” she said, reiterating the advice provided by Dr. Heath.

Dr. Heath has financial relationships with Arcutis, Janssen, Johnson & Johnson, Lilly, and Regeneron. Dr. Lester reported no potential conflicts of interest.

NEW YORK – Many inflammatory diseases, such as psoriasis and atopic dermatitis (AD), can present differently in patients with darker skin types, but it is the pigmentary changes themselves that are often a dominant concern for parents, according to pediatric dermatologist Candrice R. Heath, MD.

Skin diseases pose a greater risk of both hyper- and hypopigmentation in patients with darker skin types, but the fear and concern that this raises for permanent disfigurement is not limited to Blacks, Dr. Heath, assistant professor of pediatric dermatology at Temple University, Philadelphia, said at the Skin of Color Update 2023.

“Culturally, pigmentation changes can be huge. For people of Indian descent, for example, pigmentary changes like light spots on the skin might be an obstacle to marriage, so it can really be life changing,” she added.

In patients with darker skin tones presenting with an inflammatory skin disease, such as AD or psoriasis, Dr. Heath advised asking specifically about change in skin tone even if it is not readily apparent. In pediatric patients, it is also appropriate to include parents in this conversation.
 

Consider the parent’s perspective

“When you are taking care of a child or adolescent, the patient is likely to be concerned about changes in pigmentation, but it is important to remember that the adult in the room might have had their own journey with brown skin and has dealt with the burden of pigment changes,” Dr. Heath said.

For the parent, the pigmentation changes, rather than the inflammation, might be the governing issue and the reason that he or she brought the child to the clinician. Dr. Heath suggested that it is important for caregivers to explicitly recognize their concern, explain that addressing the pigmentary changes is part of the treatment plan, and to create realistic expectations about how long pigmentary changes will take to resolve.

As an example, Dr. Heath recounted a difficult case of a Black infant with disseminated hyperpigmentation and features that did not preclude pathology other than AD. Dr. Heath created a multifaceted treatment plan to address the inflammation in distinct areas of the body that included low-strength topical steroids for the face, stronger steroids for the body, and advice on scalp and skin care.

“I thought this was a great treatment plan out of the gate – I was covering all of the things on my differential list – I thought that the mom would be thinking, this doctor is amazing,” Dr. Heath said.
 

Pigmentary changes are a priority

However, that was not what the patient’s mother was thinking. Having failed to explicitly recognize her concern about the pigmentation changes and how the treatment would address this issue, the mother was disappointed.

“She had one question: Will my baby ever be one color? That was her main concern,” said Dr. Heath, indicating that other clinicians seeing inflammatory diseases in children with darker skin types can learn from her experience.

“Really, you have to acknowledge that the condition you are treating is causing the pigmentation change, and we do see that and that we have a treatment plan in place,” she said.

Because of differences in how inflammatory skin diseases present in darker skin types, there is plenty of room for a delayed diagnosis for clinicians who do not see many of these patients, according to Dr. Heath. Follicular eczema, which is common in skin of color, often presents with pruritus but differences in the appearance of the underlying disease can threaten a delay in diagnosis.

In cases of follicular eczema with itch in darker skin, the bumps look and feel like goose bumps, which “means that the eczema is really active and inflamed,” Dr. Heath said. When the skin becomes smooth and the itch dissipates, “you know that they are under great control.”

Psoriasis is often missed in children with darker skin types based on the misperception that it is rare. Although it is true that it is less common in Blacks than Whites, it is not rare, according to Dr. Heath. In inspecting the telltale erythematous plaque–like lesions, clinicians might start to consider alternative diagnoses when they do not detect the same erythematous appearance, but the reddish tone is often concealed in darker skin.

She said that predominant involvement in the head and neck and diaper area is often more common in children of color and that nail or scalp involvement, when present, is often a clue that psoriasis is the diagnosis.

Again, because many clinicians do not think immediately of psoriasis in darker skin children with lesions in the scalp, Dr. Heath advised this is another reason to include psoriasis in the differential diagnosis.

“If you have a child that has failed multiple courses of treatment for tinea capitis and they have well-demarcated plaques, it’s time to really start to think about pediatric psoriasis,” she said.
 

Restoring skin tone can be the priority

Asked to comment on Dr. Heath’s advice about the importance of acknowledging pigmentary changes associated with inflammatory skin diseases in patients of color, Jenna Lester, MD, the founding director of the Skin of Color Clinic at the University of California, San Francisco, called it an “often unspoken concern of patients.”

“Pigmentary changes that occur secondary to an inflammatory condition should be addressed and treated alongside the inciting condition,” she agreed.

Even if changes in skin color or skin tone are not a specific complaint of the patients, Dr. Lester also urged clinicians to raise the topic. If change in skin pigmentation is part of the clinical picture, this should be targeted in the treatment plan.

“In acne, for example, often times I find that patients are as worried about postinflammatory hyperpigmentation as they are about their acne,” she said, reiterating the advice provided by Dr. Heath.

Dr. Heath has financial relationships with Arcutis, Janssen, Johnson & Johnson, Lilly, and Regeneron. Dr. Lester reported no potential conflicts of interest.

NEW YORK – Many inflammatory diseases, such as psoriasis and atopic dermatitis (AD), can present differently in patients with darker skin types, but it is the pigmentary changes themselves that are often a dominant concern for parents, according to pediatric dermatologist Candrice R. Heath, MD.

Skin diseases pose a greater risk of both hyper- and hypopigmentation in patients with darker skin types, but the fear and concern that this raises for permanent disfigurement is not limited to Blacks, Dr. Heath, assistant professor of pediatric dermatology at Temple University, Philadelphia, said at the Skin of Color Update 2023.

“Culturally, pigmentation changes can be huge. For people of Indian descent, for example, pigmentary changes like light spots on the skin might be an obstacle to marriage, so it can really be life changing,” she added.

In patients with darker skin tones presenting with an inflammatory skin disease, such as AD or psoriasis, Dr. Heath advised asking specifically about change in skin tone even if it is not readily apparent. In pediatric patients, it is also appropriate to include parents in this conversation.
 

Consider the parent’s perspective

“When you are taking care of a child or adolescent, the patient is likely to be concerned about changes in pigmentation, but it is important to remember that the adult in the room might have had their own journey with brown skin and has dealt with the burden of pigment changes,” Dr. Heath said.

For the parent, the pigmentation changes, rather than the inflammation, might be the governing issue and the reason that he or she brought the child to the clinician. Dr. Heath suggested that it is important for caregivers to explicitly recognize their concern, explain that addressing the pigmentary changes is part of the treatment plan, and to create realistic expectations about how long pigmentary changes will take to resolve.

As an example, Dr. Heath recounted a difficult case of a Black infant with disseminated hyperpigmentation and features that did not preclude pathology other than AD. Dr. Heath created a multifaceted treatment plan to address the inflammation in distinct areas of the body that included low-strength topical steroids for the face, stronger steroids for the body, and advice on scalp and skin care.

“I thought this was a great treatment plan out of the gate – I was covering all of the things on my differential list – I thought that the mom would be thinking, this doctor is amazing,” Dr. Heath said.
 

Pigmentary changes are a priority

However, that was not what the patient’s mother was thinking. Having failed to explicitly recognize her concern about the pigmentation changes and how the treatment would address this issue, the mother was disappointed.

“She had one question: Will my baby ever be one color? That was her main concern,” said Dr. Heath, indicating that other clinicians seeing inflammatory diseases in children with darker skin types can learn from her experience.

“Really, you have to acknowledge that the condition you are treating is causing the pigmentation change, and we do see that and that we have a treatment plan in place,” she said.

Because of differences in how inflammatory skin diseases present in darker skin types, there is plenty of room for a delayed diagnosis for clinicians who do not see many of these patients, according to Dr. Heath. Follicular eczema, which is common in skin of color, often presents with pruritus but differences in the appearance of the underlying disease can threaten a delay in diagnosis.

In cases of follicular eczema with itch in darker skin, the bumps look and feel like goose bumps, which “means that the eczema is really active and inflamed,” Dr. Heath said. When the skin becomes smooth and the itch dissipates, “you know that they are under great control.”

Psoriasis is often missed in children with darker skin types based on the misperception that it is rare. Although it is true that it is less common in Blacks than Whites, it is not rare, according to Dr. Heath. In inspecting the telltale erythematous plaque–like lesions, clinicians might start to consider alternative diagnoses when they do not detect the same erythematous appearance, but the reddish tone is often concealed in darker skin.

She said that predominant involvement in the head and neck and diaper area is often more common in children of color and that nail or scalp involvement, when present, is often a clue that psoriasis is the diagnosis.

Again, because many clinicians do not think immediately of psoriasis in darker skin children with lesions in the scalp, Dr. Heath advised this is another reason to include psoriasis in the differential diagnosis.

“If you have a child that has failed multiple courses of treatment for tinea capitis and they have well-demarcated plaques, it’s time to really start to think about pediatric psoriasis,” she said.
 

Restoring skin tone can be the priority

Asked to comment on Dr. Heath’s advice about the importance of acknowledging pigmentary changes associated with inflammatory skin diseases in patients of color, Jenna Lester, MD, the founding director of the Skin of Color Clinic at the University of California, San Francisco, called it an “often unspoken concern of patients.”

“Pigmentary changes that occur secondary to an inflammatory condition should be addressed and treated alongside the inciting condition,” she agreed.

Even if changes in skin color or skin tone are not a specific complaint of the patients, Dr. Lester also urged clinicians to raise the topic. If change in skin pigmentation is part of the clinical picture, this should be targeted in the treatment plan.

“In acne, for example, often times I find that patients are as worried about postinflammatory hyperpigmentation as they are about their acne,” she said, reiterating the advice provided by Dr. Heath.

Dr. Heath has financial relationships with Arcutis, Janssen, Johnson & Johnson, Lilly, and Regeneron. Dr. Lester reported no potential conflicts of interest.

PARIS – Will the traditional newborn screening program developed 60 years ago by Dr. Robert Guthrie soon be superseded by genome screening at birth? Routine sampling and analysis of newborn DNA would allow us to screen for many hundreds of childhood genetic diseases. This is the claim made by David Geneviève, MD, PhD, chair of the French Association of Clinical Geneticists and lecturer at the University of Montpellier (France), at the 9th annual conference of the French Society of Predictive and Personalized Medicine.

To date, newborn screening has consisted of taking a drop of blood from a newborn’s heel. In the future, DNA samples could be taken from babies for whole genome sequencing to look for diseases that are likely to crop up later in life.
 

The challenge

“In France, nearly all of the 720,000 babies born each year undergo newborn screening (only 300 refuse),” said Dr. Geneviève. For 60 years, newborn screening has tested for phenylketonuria, congenital hypothyroidism, congenital adrenal hyperplasia, sickle cell disease, cystic fibrosis, and medium-chain acyl-coenzyme A dehydrogenase deficiency.

On Jan. 1, 2023, France’s national newborn screening program added seven new diseases, bringing the number of rare diseases screened for to 13. The new diseases are homocystinuria, maple syrup urine disease, tyrosinemia type 1, isovaleric acidemia, glutaric aciduria type I, long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency, and carnitine deficiency.

“There aren’t just 13 childhood diseases,” continued Dr. Geneviève. “There are several hundred rare diseases, and genome sequencing tools allow us to broaden our screening capabilities. It’s inevitable that the ability to sequence your child’s genome at birth will become a possibility. It’s highly likely that within 10-15 years, all newborns will have their genome determined at birth for screening purposes.”

Current international trials

Genome sequencing has already been studied for several years in multiple countries. New York’s Guardian study requires all newborns taking part to undergo genome sequencing. “Our English-speaking colleagues use the genome to screen for childhood diseases that would benefit from treatment (235 can be treated) but also as a preventive measure and a way of providing early therapeutic education,” said Dr. Geneviève.

In 2016, American researchers launched the BabySeq Project, which was conducted at several sites (Boston, New York, Birmingham, Detroit, and Philadelphia). One of its aims is to assess the medical, psychological, and financial impact of screening via genome sequencing at birth, compared with conventional screening.

In North Carolina, 25,000 newborns took part in the Early Check study, a neonatal genetic screening project focusing on childhood spinal muscular atrophy, fragile X syndrome, and Duchenne muscular dystrophy.

In the United Kingdom, Genomics England seeks to assess the feasibility, benefits, and risks of whole genome sequencing as part of the Newborn Genomes Programme, an analysis of 100,000 newborn genomes. Projects are also underway in Belgium, Italy, and France (PeriGEN MED in Dijon).
 

Dijon’s specialist team

The conditions for considering neonatal screening of a disease are determined by the health care authorities in each country and vary greatly from one state to the next.

To date, in France, the only genetic screening authorized is for childhood spinal muscular atrophy via identification of an anomaly on SMN1. It has not yet been implemented, but a pilot study of its use is underway.

“If we are able to identify the 40 newborns affected by spinal muscular atrophy from birth, we can offer these patients gene therapy and stop them from dying at 1 or 2 years of age,” said Dr. Geneviève.

In the future, France should draw up a list of diseases for which genetic screening is useful, he added.

Although France’s initiative for genomic medicine, France Génomique 2025, does not envisage a neonatal genome sequencing screening program, a team in Dijon is studying several dozen genomes to determine the medical and financial benefits of such a program, explained Dr. Geneviève.
 

Ethical issues

Of course, this technological achievement raises ethical issues. “What do we do with the genetic data obtained at birth that won’t become apparent until adulthood, if we find a BRCA1 or BRCA2 variant in a newborn’s genome?” asked Dr. Genevieve.

Will the information obtained be stored somewhere? “This is a real issue,” he said. “The English have a national system. In their newborn screening program, when an infant grows into adulthood, he or she can have access to the genetic data.”

There is also a big risk that women will be pressured to undergo genetic testing during pregnancy. “No genome-related antenatal tests are carried out unless there are concerning ultrasound findings and only to look for particularly severe incurable diseases,” said Dr. Geneviève.
 

Not like Gattaca*

Financial obstacles should be quickly pushed aside. The cost of genome sequencing has decreased in the past few years. The first sequencing in 2003 cost close to $3 billion. Nowadays, it can be done for less than 1,000 € (just over $1,000).

Although neonatal genetic screening would enable us to limit the development of serious diseases, the decision to use such testing routinely must be made by society as a whole, Dr. Geneviève concluded.

“We often oppose preventive and personalized treatment strategies. Now the two have joined forces,” said Pascal Pujol, MD, PhD, chair of SFMPP.

For Dr. Pujol, broadening the application of genome sequencing is a no-brainer. “It won’t be like in Gattaca,” he reassures us. “It wouldn’t be done to determine a person’s character but [rather] to prevent those rare diseases that affect 4 to 5% of the population.”

*A reference to Andrew Niccol’s 1997 science fiction movie Gattaca. The film is set in a futuristic world in which parents can choose the genotype of their children to conceive test-tube babies with the fewest defects and the most advantages possible for society.

This article was translated from the Medscape French edition and a version appeared on Medscape.com.

PARIS – Will the traditional newborn screening program developed 60 years ago by Dr. Robert Guthrie soon be superseded by genome screening at birth? Routine sampling and analysis of newborn DNA would allow us to screen for many hundreds of childhood genetic diseases. This is the claim made by David Geneviève, MD, PhD, chair of the French Association of Clinical Geneticists and lecturer at the University of Montpellier (France), at the 9th annual conference of the French Society of Predictive and Personalized Medicine.

To date, newborn screening has consisted of taking a drop of blood from a newborn’s heel. In the future, DNA samples could be taken from babies for whole genome sequencing to look for diseases that are likely to crop up later in life.
 

The challenge

“In France, nearly all of the 720,000 babies born each year undergo newborn screening (only 300 refuse),” said Dr. Geneviève. For 60 years, newborn screening has tested for phenylketonuria, congenital hypothyroidism, congenital adrenal hyperplasia, sickle cell disease, cystic fibrosis, and medium-chain acyl-coenzyme A dehydrogenase deficiency.

On Jan. 1, 2023, France’s national newborn screening program added seven new diseases, bringing the number of rare diseases screened for to 13. The new diseases are homocystinuria, maple syrup urine disease, tyrosinemia type 1, isovaleric acidemia, glutaric aciduria type I, long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency, and carnitine deficiency.

“There aren’t just 13 childhood diseases,” continued Dr. Geneviève. “There are several hundred rare diseases, and genome sequencing tools allow us to broaden our screening capabilities. It’s inevitable that the ability to sequence your child’s genome at birth will become a possibility. It’s highly likely that within 10-15 years, all newborns will have their genome determined at birth for screening purposes.”

Current international trials

Genome sequencing has already been studied for several years in multiple countries. New York’s Guardian study requires all newborns taking part to undergo genome sequencing. “Our English-speaking colleagues use the genome to screen for childhood diseases that would benefit from treatment (235 can be treated) but also as a preventive measure and a way of providing early therapeutic education,” said Dr. Geneviève.

In 2016, American researchers launched the BabySeq Project, which was conducted at several sites (Boston, New York, Birmingham, Detroit, and Philadelphia). One of its aims is to assess the medical, psychological, and financial impact of screening via genome sequencing at birth, compared with conventional screening.

In North Carolina, 25,000 newborns took part in the Early Check study, a neonatal genetic screening project focusing on childhood spinal muscular atrophy, fragile X syndrome, and Duchenne muscular dystrophy.

In the United Kingdom, Genomics England seeks to assess the feasibility, benefits, and risks of whole genome sequencing as part of the Newborn Genomes Programme, an analysis of 100,000 newborn genomes. Projects are also underway in Belgium, Italy, and France (PeriGEN MED in Dijon).
 

Dijon’s specialist team

The conditions for considering neonatal screening of a disease are determined by the health care authorities in each country and vary greatly from one state to the next.

To date, in France, the only genetic screening authorized is for childhood spinal muscular atrophy via identification of an anomaly on SMN1. It has not yet been implemented, but a pilot study of its use is underway.

“If we are able to identify the 40 newborns affected by spinal muscular atrophy from birth, we can offer these patients gene therapy and stop them from dying at 1 or 2 years of age,” said Dr. Geneviève.

In the future, France should draw up a list of diseases for which genetic screening is useful, he added.

Although France’s initiative for genomic medicine, France Génomique 2025, does not envisage a neonatal genome sequencing screening program, a team in Dijon is studying several dozen genomes to determine the medical and financial benefits of such a program, explained Dr. Geneviève.
 

Ethical issues

Of course, this technological achievement raises ethical issues. “What do we do with the genetic data obtained at birth that won’t become apparent until adulthood, if we find a BRCA1 or BRCA2 variant in a newborn’s genome?” asked Dr. Genevieve.

Will the information obtained be stored somewhere? “This is a real issue,” he said. “The English have a national system. In their newborn screening program, when an infant grows into adulthood, he or she can have access to the genetic data.”

There is also a big risk that women will be pressured to undergo genetic testing during pregnancy. “No genome-related antenatal tests are carried out unless there are concerning ultrasound findings and only to look for particularly severe incurable diseases,” said Dr. Geneviève.
 

Not like Gattaca*

Financial obstacles should be quickly pushed aside. The cost of genome sequencing has decreased in the past few years. The first sequencing in 2003 cost close to $3 billion. Nowadays, it can be done for less than 1,000 € (just over $1,000).

Although neonatal genetic screening would enable us to limit the development of serious diseases, the decision to use such testing routinely must be made by society as a whole, Dr. Geneviève concluded.

“We often oppose preventive and personalized treatment strategies. Now the two have joined forces,” said Pascal Pujol, MD, PhD, chair of SFMPP.

For Dr. Pujol, broadening the application of genome sequencing is a no-brainer. “It won’t be like in Gattaca,” he reassures us. “It wouldn’t be done to determine a person’s character but [rather] to prevent those rare diseases that affect 4 to 5% of the population.”

*A reference to Andrew Niccol’s 1997 science fiction movie Gattaca. The film is set in a futuristic world in which parents can choose the genotype of their children to conceive test-tube babies with the fewest defects and the most advantages possible for society.

This article was translated from the Medscape French edition and a version appeared on Medscape.com.

PARIS – Will the traditional newborn screening program developed 60 years ago by Dr. Robert Guthrie soon be superseded by genome screening at birth? Routine sampling and analysis of newborn DNA would allow us to screen for many hundreds of childhood genetic diseases. This is the claim made by David Geneviève, MD, PhD, chair of the French Association of Clinical Geneticists and lecturer at the University of Montpellier (France), at the 9th annual conference of the French Society of Predictive and Personalized Medicine.

To date, newborn screening has consisted of taking a drop of blood from a newborn’s heel. In the future, DNA samples could be taken from babies for whole genome sequencing to look for diseases that are likely to crop up later in life.
 

The challenge

“In France, nearly all of the 720,000 babies born each year undergo newborn screening (only 300 refuse),” said Dr. Geneviève. For 60 years, newborn screening has tested for phenylketonuria, congenital hypothyroidism, congenital adrenal hyperplasia, sickle cell disease, cystic fibrosis, and medium-chain acyl-coenzyme A dehydrogenase deficiency.

On Jan. 1, 2023, France’s national newborn screening program added seven new diseases, bringing the number of rare diseases screened for to 13. The new diseases are homocystinuria, maple syrup urine disease, tyrosinemia type 1, isovaleric acidemia, glutaric aciduria type I, long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency, and carnitine deficiency.

“There aren’t just 13 childhood diseases,” continued Dr. Geneviève. “There are several hundred rare diseases, and genome sequencing tools allow us to broaden our screening capabilities. It’s inevitable that the ability to sequence your child’s genome at birth will become a possibility. It’s highly likely that within 10-15 years, all newborns will have their genome determined at birth for screening purposes.”

Current international trials

Genome sequencing has already been studied for several years in multiple countries. New York’s Guardian study requires all newborns taking part to undergo genome sequencing. “Our English-speaking colleagues use the genome to screen for childhood diseases that would benefit from treatment (235 can be treated) but also as a preventive measure and a way of providing early therapeutic education,” said Dr. Geneviève.

In 2016, American researchers launched the BabySeq Project, which was conducted at several sites (Boston, New York, Birmingham, Detroit, and Philadelphia). One of its aims is to assess the medical, psychological, and financial impact of screening via genome sequencing at birth, compared with conventional screening.

In North Carolina, 25,000 newborns took part in the Early Check study, a neonatal genetic screening project focusing on childhood spinal muscular atrophy, fragile X syndrome, and Duchenne muscular dystrophy.

In the United Kingdom, Genomics England seeks to assess the feasibility, benefits, and risks of whole genome sequencing as part of the Newborn Genomes Programme, an analysis of 100,000 newborn genomes. Projects are also underway in Belgium, Italy, and France (PeriGEN MED in Dijon).
 

Dijon’s specialist team

The conditions for considering neonatal screening of a disease are determined by the health care authorities in each country and vary greatly from one state to the next.

To date, in France, the only genetic screening authorized is for childhood spinal muscular atrophy via identification of an anomaly on SMN1. It has not yet been implemented, but a pilot study of its use is underway.

“If we are able to identify the 40 newborns affected by spinal muscular atrophy from birth, we can offer these patients gene therapy and stop them from dying at 1 or 2 years of age,” said Dr. Geneviève.

In the future, France should draw up a list of diseases for which genetic screening is useful, he added.

Although France’s initiative for genomic medicine, France Génomique 2025, does not envisage a neonatal genome sequencing screening program, a team in Dijon is studying several dozen genomes to determine the medical and financial benefits of such a program, explained Dr. Geneviève.
 

Ethical issues

Of course, this technological achievement raises ethical issues. “What do we do with the genetic data obtained at birth that won’t become apparent until adulthood, if we find a BRCA1 or BRCA2 variant in a newborn’s genome?” asked Dr. Genevieve.

Will the information obtained be stored somewhere? “This is a real issue,” he said. “The English have a national system. In their newborn screening program, when an infant grows into adulthood, he or she can have access to the genetic data.”

There is also a big risk that women will be pressured to undergo genetic testing during pregnancy. “No genome-related antenatal tests are carried out unless there are concerning ultrasound findings and only to look for particularly severe incurable diseases,” said Dr. Geneviève.
 

Not like Gattaca*

Financial obstacles should be quickly pushed aside. The cost of genome sequencing has decreased in the past few years. The first sequencing in 2003 cost close to $3 billion. Nowadays, it can be done for less than 1,000 € (just over $1,000).

Although neonatal genetic screening would enable us to limit the development of serious diseases, the decision to use such testing routinely must be made by society as a whole, Dr. Geneviève concluded.

“We often oppose preventive and personalized treatment strategies. Now the two have joined forces,” said Pascal Pujol, MD, PhD, chair of SFMPP.

For Dr. Pujol, broadening the application of genome sequencing is a no-brainer. “It won’t be like in Gattaca,” he reassures us. “It wouldn’t be done to determine a person’s character but [rather] to prevent those rare diseases that affect 4 to 5% of the population.”

*A reference to Andrew Niccol’s 1997 science fiction movie Gattaca. The film is set in a futuristic world in which parents can choose the genotype of their children to conceive test-tube babies with the fewest defects and the most advantages possible for society.

This article was translated from the Medscape French edition and a version appeared on Medscape.com.

UnitedHealthcare (UHC) is the latest payer accused of using artificial intelligence (AI) to deny patient claims by trading “real doctors’ recommendations” for a flawed algorithm to save money.

In a class action suit filed in Minnesota district court, the attorneys for the families of two deceased UHC Medicare Advantage plan policyholders say that the company uses the technology to systematically deny skilled nursing facility (SNF) claims and shirk its responsibility to adhere to Medicare’s coverage determination standards.

The case raises ethical and legal questions about whether AI can replace or supplement human tasks and interactions, particularly in a field as complex as health care. California-based public advocacy firm Clarkson Law filed a similar complaint against Cigna earlier this year and has previously sued tech giants Google and ChatGPT creator OpenAI for harvesting Internet users’ data to train their AI systems.

Clarkson Law represents the plaintiffs and says that the policyholders had to pay thousands in out-of-pocket costs or forgo the recommended postacute care owing to UHC’s faulty AI model, nH Predict. The tool has a 90% error rate, says the lawsuit, as evidenced by the number of claims that are reversed following review by a medical professional. Still, just 0.2% of policyholders appeal the denials.

nH Predict was created by naviHealth and was acquired by UnitedHealth Group, UHC’s parent company, in 2020. In a statement to Bloomberg Law, a spokesperson for naviHealth said that the lawsuit has no merit and the model was not used for making coverage determinations.

According to the complaint, nH Predict determines the appropriate amount of SNF, home health, or rehabilitation services a patient requires on the basis of the diagnosis, age, and living situation. The model compares the patient with its database of 6 million patients and estimates the ideal length of stay and target discharge date, “pinpointing the precise moment when [UHC] will cut off payment for a patient’s treatment.”

The lawsuit says that employees are instructed to strictly adhere to the AI model’s predictions, and those who do not are disciplined and terminated, even when additional care for the patient is warranted. Employees are told that the generated reports contain proprietary information and that they cannot share them with physicians and patients who inquire about extending care.

“Every patient is entitled to a nuanced evaluation of their health care needs,” Zarrina Ozari, senior associate at Clarkson Law, said in a prepared statement. “By replacing licensed practitioners with unchecked AI, UHC is telling its patients that they are completely interchangeable with one another and undervaluing the expertise of the physicians devoted to key elements of care.”

According to the complaint, Gene Lokken fell in May 2022 and fractured his leg and ankle. After a 1-month SNF stay, the 91-year-old man’s doctor ordered physical therapy. However, the insurer said Mr. Lokken was safe to be discharged home two and a half weeks later, conflicting with a physical therapist’s notes that indicated he still had paralyzed and weak muscles. The insurer denied Mr. Lokken’s appeal. He remained in the facility for another year until his death, paying about $150,000 in out-of-pocket expenses, according to the lawsuit.

Another patient, Dale H. Tetzloff, initially spent just 20 days in a SNF for stroke rehabilitation before UHC denied coverage. An appeal later extended the stay to 40 days, short of the 100 days recommended by his physician. Requests for further extensions were unsuccessful, and Mr. Tetzloff ultimately paid about $70,000 in out-of-pocket expenses over the next 10 months, according to the complaint.

New federal rules prohibit Medicare Advantage plans from relying on an algorithm or software to make medically necessary determinations instead of an individual’s specific circumstances. Any medical necessity denial must be “reviewed by a physician or other appropriate health care professional with expertise in the field of medicine or health care that is appropriate for the service at issue.”

Clarkson is demanding a jury trial and has asked the court to certify the case as a federal class action, which could open the suit to any U.S. resident who purchased a UHC Medicare Advantage plan in the past 4 years.

A version of this article appeared on Medscape.com.

UnitedHealthcare (UHC) is the latest payer accused of using artificial intelligence (AI) to deny patient claims by trading “real doctors’ recommendations” for a flawed algorithm to save money.

In a class action suit filed in Minnesota district court, the attorneys for the families of two deceased UHC Medicare Advantage plan policyholders say that the company uses the technology to systematically deny skilled nursing facility (SNF) claims and shirk its responsibility to adhere to Medicare’s coverage determination standards.

The case raises ethical and legal questions about whether AI can replace or supplement human tasks and interactions, particularly in a field as complex as health care. California-based public advocacy firm Clarkson Law filed a similar complaint against Cigna earlier this year and has previously sued tech giants Google and ChatGPT creator OpenAI for harvesting Internet users’ data to train their AI systems.

Clarkson Law represents the plaintiffs and says that the policyholders had to pay thousands in out-of-pocket costs or forgo the recommended postacute care owing to UHC’s faulty AI model, nH Predict. The tool has a 90% error rate, says the lawsuit, as evidenced by the number of claims that are reversed following review by a medical professional. Still, just 0.2% of policyholders appeal the denials.

nH Predict was created by naviHealth and was acquired by UnitedHealth Group, UHC’s parent company, in 2020. In a statement to Bloomberg Law, a spokesperson for naviHealth said that the lawsuit has no merit and the model was not used for making coverage determinations.

According to the complaint, nH Predict determines the appropriate amount of SNF, home health, or rehabilitation services a patient requires on the basis of the diagnosis, age, and living situation. The model compares the patient with its database of 6 million patients and estimates the ideal length of stay and target discharge date, “pinpointing the precise moment when [UHC] will cut off payment for a patient’s treatment.”

The lawsuit says that employees are instructed to strictly adhere to the AI model’s predictions, and those who do not are disciplined and terminated, even when additional care for the patient is warranted. Employees are told that the generated reports contain proprietary information and that they cannot share them with physicians and patients who inquire about extending care.

“Every patient is entitled to a nuanced evaluation of their health care needs,” Zarrina Ozari, senior associate at Clarkson Law, said in a prepared statement. “By replacing licensed practitioners with unchecked AI, UHC is telling its patients that they are completely interchangeable with one another and undervaluing the expertise of the physicians devoted to key elements of care.”

According to the complaint, Gene Lokken fell in May 2022 and fractured his leg and ankle. After a 1-month SNF stay, the 91-year-old man’s doctor ordered physical therapy. However, the insurer said Mr. Lokken was safe to be discharged home two and a half weeks later, conflicting with a physical therapist’s notes that indicated he still had paralyzed and weak muscles. The insurer denied Mr. Lokken’s appeal. He remained in the facility for another year until his death, paying about $150,000 in out-of-pocket expenses, according to the lawsuit.

Another patient, Dale H. Tetzloff, initially spent just 20 days in a SNF for stroke rehabilitation before UHC denied coverage. An appeal later extended the stay to 40 days, short of the 100 days recommended by his physician. Requests for further extensions were unsuccessful, and Mr. Tetzloff ultimately paid about $70,000 in out-of-pocket expenses over the next 10 months, according to the complaint.

New federal rules prohibit Medicare Advantage plans from relying on an algorithm or software to make medically necessary determinations instead of an individual’s specific circumstances. Any medical necessity denial must be “reviewed by a physician or other appropriate health care professional with expertise in the field of medicine or health care that is appropriate for the service at issue.”

Clarkson is demanding a jury trial and has asked the court to certify the case as a federal class action, which could open the suit to any U.S. resident who purchased a UHC Medicare Advantage plan in the past 4 years.

A version of this article appeared on Medscape.com.

UnitedHealthcare (UHC) is the latest payer accused of using artificial intelligence (AI) to deny patient claims by trading “real doctors’ recommendations” for a flawed algorithm to save money.

In a class action suit filed in Minnesota district court, the attorneys for the families of two deceased UHC Medicare Advantage plan policyholders say that the company uses the technology to systematically deny skilled nursing facility (SNF) claims and shirk its responsibility to adhere to Medicare’s coverage determination standards.

The case raises ethical and legal questions about whether AI can replace or supplement human tasks and interactions, particularly in a field as complex as health care. California-based public advocacy firm Clarkson Law filed a similar complaint against Cigna earlier this year and has previously sued tech giants Google and ChatGPT creator OpenAI for harvesting Internet users’ data to train their AI systems.

Clarkson Law represents the plaintiffs and says that the policyholders had to pay thousands in out-of-pocket costs or forgo the recommended postacute care owing to UHC’s faulty AI model, nH Predict. The tool has a 90% error rate, says the lawsuit, as evidenced by the number of claims that are reversed following review by a medical professional. Still, just 0.2% of policyholders appeal the denials.

nH Predict was created by naviHealth and was acquired by UnitedHealth Group, UHC’s parent company, in 2020. In a statement to Bloomberg Law, a spokesperson for naviHealth said that the lawsuit has no merit and the model was not used for making coverage determinations.

According to the complaint, nH Predict determines the appropriate amount of SNF, home health, or rehabilitation services a patient requires on the basis of the diagnosis, age, and living situation. The model compares the patient with its database of 6 million patients and estimates the ideal length of stay and target discharge date, “pinpointing the precise moment when [UHC] will cut off payment for a patient’s treatment.”

The lawsuit says that employees are instructed to strictly adhere to the AI model’s predictions, and those who do not are disciplined and terminated, even when additional care for the patient is warranted. Employees are told that the generated reports contain proprietary information and that they cannot share them with physicians and patients who inquire about extending care.

“Every patient is entitled to a nuanced evaluation of their health care needs,” Zarrina Ozari, senior associate at Clarkson Law, said in a prepared statement. “By replacing licensed practitioners with unchecked AI, UHC is telling its patients that they are completely interchangeable with one another and undervaluing the expertise of the physicians devoted to key elements of care.”

According to the complaint, Gene Lokken fell in May 2022 and fractured his leg and ankle. After a 1-month SNF stay, the 91-year-old man’s doctor ordered physical therapy. However, the insurer said Mr. Lokken was safe to be discharged home two and a half weeks later, conflicting with a physical therapist’s notes that indicated he still had paralyzed and weak muscles. The insurer denied Mr. Lokken’s appeal. He remained in the facility for another year until his death, paying about $150,000 in out-of-pocket expenses, according to the lawsuit.

Another patient, Dale H. Tetzloff, initially spent just 20 days in a SNF for stroke rehabilitation before UHC denied coverage. An appeal later extended the stay to 40 days, short of the 100 days recommended by his physician. Requests for further extensions were unsuccessful, and Mr. Tetzloff ultimately paid about $70,000 in out-of-pocket expenses over the next 10 months, according to the complaint.

New federal rules prohibit Medicare Advantage plans from relying on an algorithm or software to make medically necessary determinations instead of an individual’s specific circumstances. Any medical necessity denial must be “reviewed by a physician or other appropriate health care professional with expertise in the field of medicine or health care that is appropriate for the service at issue.”

Clarkson is demanding a jury trial and has asked the court to certify the case as a federal class action, which could open the suit to any U.S. resident who purchased a UHC Medicare Advantage plan in the past 4 years.

A version of this article appeared on Medscape.com.

You’ve just received an offer letter from that job you interviewed for. Sometimes you want to let the employer know right away how interested you are. The verbiage says the letter isn’t “binding.” So you eagerly sign on the dotted line. Everything looks great ... until it isn’t.

Attorney Ericka Adler, JD, LLM, a partner at Roetzel & Andress, a Chicago-based law firm that represents physicians and health care professionals nationwide, described her client who was in this predicament. The physician, a dermatologist, left a practice where she had been employed because she had received an “amazing” offer letter that included promises about her new work location, staffing, equipment, and hours. She signed and immediately gave notice to her previous employer.

“When she received the actual employment contract, none of those details from the offer letter – which is also called a letter of intent [LOI] – were included,” Ms. Adler told this news organization. The physician wanted to have the details from the LOI formally spelled out in the contract, but the employer refused.

“Basically, they said, ‘This is our standard contract and you’ll just have to trust us that we’ll keep our word. We meant what we said in the LOI, but we cannot include those details in the actual agreement because everyone has the same form of agreement.’ “ The physician decided to sign the contract and accept the position.

She contacted Ms. Adler after she had been at her new position for a month. “She had received none of the things they had promised her in the LOI,” Ms. Adler reported. “She lacked the NP and PA support, she lacked the equipment, she didn’t have enough exam rooms. As soon as she started, someone with whom she was sharing call coverage left, and she was expected to take over. The LOI had a cap on the amount of call she would be required to take, but that verbiage didn’t make it into the contract.”

Ms. Adler tried to address this issue with the employer. “We couldn’t say they had literally breached the agreement, but we did list the things that were mentioned in the LOI but on which they hadn’t delivered. We asked them to fix the issue within 10 days.”

The employer argued “that they didn’t have to fulfill anything that wasn’t spelled out in the contract, even if it was in the LOI. In fact, the contract specified clearly that the signed employment agreement was the only agreement and replaced any previous written or oral agreements between the parties.”

The dermatologist ultimately left the new position. “She might have been able to have a legal claim against the employer for breach or perhaps ‘detrimental reliance’ – meaning, she might have argued that she had been financially harmed due to the false promises made to her. But it would have been difficult and expensive for her to litigate the issue,” said Ms. Adler.

“It also didn’t seem like the physician could remain in the job and develop a positive work relationship with the employer, given that she felt betrayed and misled, and didn’t like the terms of employment, which didn’t match her needs or expectations,” said Ms. Adler.

She added that “most employers are not as unscrupulous and dishonest as this one was. But some employers do play on the fact that younger doctors – especially residents and fellows – tend to be trusting or feel they don’t have negotiation power. They’re often excited to get an offer and sign it without a second thought.”

That’s why she advises physicians to “review the terms of the LOI carefully and make sure you’re comfortable with them before signing it; but know that the real contract to negotiate will be the actual Employment Agreement.”

She also advises physicians not to give notice at their current place of employment until they’ve signed the final contract with the new employer.
 

On the same page?

Anu Murthy, JD, an attorney and associate contract review specialist at Contract Diagnostics, explained that the LOI is a document that the candidate receives after an interview but before a full contract. Sometimes, the LOI is preceded by a verbal or e-mailed offer, which is less formal.

“An LOI is sometimes called a Term Sheet or Memorandum of Understanding,“ Ms. Murthy told this news organization. “Typically, it lays out key provisions, such as compensation, initial term of the contract, location, and recruitment incentives.” Sometimes it includes mention of staffing, call schedule, malpractice, noncompete covenants, and other components of the position.

Justin Nabity, founder and CEO of Physicians Thrive, a physician financial advisory group, said that LOIs are “a way for employers to gauge a prospective employee’s level of interest.”

The employer “doesn’t want to send a contract with a lot of details before determining whether the candidate is really serious about the position, so the offer letter doesn’t show the whole picture,” Mr. Nabity told this news organization.

Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, agreed.

“Another way of putting it is that the employer wants to see whether the prospective employee is on the same page. The LOI will typically include some key components that will later appear in a more complete and formal contract, together with other topics and details. Agreeing to those key components signals that indeed you and the employer are in accord,” said Mr. Hursh.

But are you really on the same page with your prospective employer? And if you seem to be on the same page, and you sign the LOI, is that a guarantee that the employer will honor its terms?

Not necessarily, according to the experts. In fact, many LOIs contain some verbiage stating that the letter isn’t binding, which can be confusing. Others suggest that it is binding, but the candidate doesn’t realize that the letter isn’t a formal contract and that the contract may contain details not included in the LOI or may omit details mentioned in the LOI, as happened to Ms. Adler’s unfortunate client.

“One of the pitfalls I see is that doctors sign the LOI without recognizing whether it’s binding or nonbinding,” Ms. Murthy said. “If it’s binding, it creates a legal obligation on your part and could preclude you from further negotiation once you see the contract and feel you’d like to negotiate some of its terms.”

Binding letters are typically offered to candidates after some back-and-forth between the parties, and important terms have been agreed to, which can happen either verbally or via e-mail. Once these agreements have been reached, they’re summarized in a “binding” letter before being extended into a full contract.

“But even if you’ve agreed on the terms verbally, it’s still important to have someone more experienced review the offer letter before signing it,” Ms. Murthy said. “It’s important to understand the ‘legalese’ and what your rights and obligations are before agreeing to anything.”

And certainly, if you receive a binding LOI, you shouldn’t sign anything until you’re sure you’re comfortable with its contents and have more details.
 

Are “nonbinding” LOIs really not binding?

Even if the LOI is nonbinding, that doesn’t necessarily mean you can sign it and expect to negotiate later. “I see people tripped up when they sign the LOI, thinking they’ll negotiate later,” said Mr. Hursh. “They may not like the terms – for example, they think the compensation is too low – and they figure they’ll work it out at the contract stage, because the LOI is ‘not legally binding.’ “

But because the candidate signed the LOI, “the employer is under the impression that the compensation was acceptable, so now you’ve tied your hands – and the hands of any attorney you may consult down the road – to negotiate those terms.”

Mr. Hursh said he is often consulted by physicians who signed the contract “to get the ball rolling,” thinking that the LOI was “just a meaningless bureaucratic paper.” They need to understand “that the employer wants to make sure they’re in agreement on the basic points before getting into the details,” he said. “Large hospitals with in-house counsel may not want to use their legal department’s valuable time in redrafting terms they thought were acceptable to the candidate, and most practices don’t want to pay a lawyer to draft an LOI and then come back and say, ‘Actually, the physician wants more compensation.’ “

Mr. Nabity summarized: “The LOI is essentially a negotiation tactic to take some of the cards out of the hands of the doctor and commit him or her to something they’re not ready to commit to.” Employers may be playing on the sense of pressure and candidate’s fear that the job will slip through their fingers if they wait too long to sign. “But it’s better to wait longer at this stage before signing even a nonbinding LOI,” he said.

What to do before signing

So how should physicians relate to the LOI? Mr. Nabity advises “working through the details of the offer letter first, going through it carefully and identifying areas of concern, bearing in mind that employers never begin with their best offer.”

He pointed out that physicians “rarely know their value and usually don’t know how to work through the dynamics of compensation, call schedules, additional incentives, bonuses, and productivity,” so they need to be informed about these areas before signing anything.

Ms. Murthy recommended “going back and saying [to the prospective employer], ‘Thank you, but I need time to consider and evaluate this offer.’ Then, do some due diligence.”

At that point, you can hire an attorney to go over the offer, educate yourself about compensation benchmarks and what your worth actually is, or consult another trained professional or more experienced individual who can review the LOI before you sign it.

That’s what Dominique Cleveland, MD, a Texas-based ob.gyn., did when she received an LOI 5 years ago.

“The offer letter from the group practice contained a statement that the group wanted me to come on board, what the salary would be, and the time frame that would be covered in the contract,” she told this news organization. “It mentioned benefits and incentives and relocation, but it was only a short document – maybe one or two pages long.”

At the time that she received her LOI, Dr. Cleveland was completing her residency. She consulted experienced faculty members from her institution to find out whether the terms laid out in the LOI “were the norm and were reasonable.” She was “fairly certain” that the salary was low and this was confirmed by the faculty members she talked to. “So I felt comfortable asking for more [compensation],” she said.

The employer was receptive to her proposed changes, which were included in the more detailed contract that followed. “I can’t say there were any surprises per se in the contract because I had negotiated my salary after receiving the offer letter,” she said. She accepted the position and has been working there ever since.

Dr. Cleveland advises physicians “not to make a decision without speaking to someone who’s experienced and can help you compare what’s out there.”

She also encourages physicians to ask for what they want, whether it’s compensation or something else, such as call schedule or vacation time, without being afraid. “I’m a firm believer that you won’t know what you can get if you don’t ask for it,” she said.
 

Negotiation tips

Mr. Nabity recommended not agreeing to any terms until you are ready to enter into negotiation, recognizing that negotiation is an “art” that requires skill and training. “Either get trained in negotiation, perhaps taking courses to advocate for yourself – which is rare, and most doctors aren’t likely to do this – or go to a trained advocate, such as a lawyer, who can do so on your behalf.”

You might share your concerns with the person who interviewed you, with the person whose name is on the LOI, or with the recruiter who can advocate on your behalf, Ms. Murthy said. “You can reach out to the recruiter and say, ‘I really appreciate the opportunity, but there are some things in the offer letter I’d like to continue discussing.’ “

When you’re ready to negotiate, be sure to assemble all of your “asks” in a single document rather than going back to the prospective employer with “multiple individual questions multiple times,” Ms. Murthy advised. It’s more efficient and the employer or recruiter will appreciate that.

She also advised couching your request in language that expresses your appreciation for the offer and stating that you would like the agreement to serve the best interests of both parties. “Use open-ended language like that, and ask if it’s all right for you to send back some questions, ask for clarification, or share concerns.”

Most employers “will be fine with that,” Ms. Murthy said. “Most won’t say, ‘This is it, take it or leave it.’ If they do, that’s a red flag for you to reconsider whether you really want to work for this particular employer.”

Mr. Hursh suggested that if you choose to sign the LOI immediately, so as to rapidly let the prospective employer know of your interest, “you should add some type of qualification such as, ‘I’m signing this to express my interest, but accepting the position will be dependent upon a more thorough review of compensation benchmarks,’ for example.”

Mr. Nabity agreed: “You can add a handwritten note to the signed LOI expressing that you’re eager to move forward and proceed with the position, but it shouldn’t be construed as accepting the terms of the LOI until you’ve seen the full contract.

“Remember, health care can’t exist without doctors,” Mr. Nabity said. “Doctors are the star players and should go into the negotiation process recognizing their true worth.”
 

A version of this article appeared on Medscape.com.

You’ve just received an offer letter from that job you interviewed for. Sometimes you want to let the employer know right away how interested you are. The verbiage says the letter isn’t “binding.” So you eagerly sign on the dotted line. Everything looks great ... until it isn’t.

Attorney Ericka Adler, JD, LLM, a partner at Roetzel & Andress, a Chicago-based law firm that represents physicians and health care professionals nationwide, described her client who was in this predicament. The physician, a dermatologist, left a practice where she had been employed because she had received an “amazing” offer letter that included promises about her new work location, staffing, equipment, and hours. She signed and immediately gave notice to her previous employer.

“When she received the actual employment contract, none of those details from the offer letter – which is also called a letter of intent [LOI] – were included,” Ms. Adler told this news organization. The physician wanted to have the details from the LOI formally spelled out in the contract, but the employer refused.

“Basically, they said, ‘This is our standard contract and you’ll just have to trust us that we’ll keep our word. We meant what we said in the LOI, but we cannot include those details in the actual agreement because everyone has the same form of agreement.’ “ The physician decided to sign the contract and accept the position.

She contacted Ms. Adler after she had been at her new position for a month. “She had received none of the things they had promised her in the LOI,” Ms. Adler reported. “She lacked the NP and PA support, she lacked the equipment, she didn’t have enough exam rooms. As soon as she started, someone with whom she was sharing call coverage left, and she was expected to take over. The LOI had a cap on the amount of call she would be required to take, but that verbiage didn’t make it into the contract.”

Ms. Adler tried to address this issue with the employer. “We couldn’t say they had literally breached the agreement, but we did list the things that were mentioned in the LOI but on which they hadn’t delivered. We asked them to fix the issue within 10 days.”

The employer argued “that they didn’t have to fulfill anything that wasn’t spelled out in the contract, even if it was in the LOI. In fact, the contract specified clearly that the signed employment agreement was the only agreement and replaced any previous written or oral agreements between the parties.”

The dermatologist ultimately left the new position. “She might have been able to have a legal claim against the employer for breach or perhaps ‘detrimental reliance’ – meaning, she might have argued that she had been financially harmed due to the false promises made to her. But it would have been difficult and expensive for her to litigate the issue,” said Ms. Adler.

“It also didn’t seem like the physician could remain in the job and develop a positive work relationship with the employer, given that she felt betrayed and misled, and didn’t like the terms of employment, which didn’t match her needs or expectations,” said Ms. Adler.

She added that “most employers are not as unscrupulous and dishonest as this one was. But some employers do play on the fact that younger doctors – especially residents and fellows – tend to be trusting or feel they don’t have negotiation power. They’re often excited to get an offer and sign it without a second thought.”

That’s why she advises physicians to “review the terms of the LOI carefully and make sure you’re comfortable with them before signing it; but know that the real contract to negotiate will be the actual Employment Agreement.”

She also advises physicians not to give notice at their current place of employment until they’ve signed the final contract with the new employer.
 

On the same page?

Anu Murthy, JD, an attorney and associate contract review specialist at Contract Diagnostics, explained that the LOI is a document that the candidate receives after an interview but before a full contract. Sometimes, the LOI is preceded by a verbal or e-mailed offer, which is less formal.

“An LOI is sometimes called a Term Sheet or Memorandum of Understanding,“ Ms. Murthy told this news organization. “Typically, it lays out key provisions, such as compensation, initial term of the contract, location, and recruitment incentives.” Sometimes it includes mention of staffing, call schedule, malpractice, noncompete covenants, and other components of the position.

Justin Nabity, founder and CEO of Physicians Thrive, a physician financial advisory group, said that LOIs are “a way for employers to gauge a prospective employee’s level of interest.”

The employer “doesn’t want to send a contract with a lot of details before determining whether the candidate is really serious about the position, so the offer letter doesn’t show the whole picture,” Mr. Nabity told this news organization.

Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, agreed.

“Another way of putting it is that the employer wants to see whether the prospective employee is on the same page. The LOI will typically include some key components that will later appear in a more complete and formal contract, together with other topics and details. Agreeing to those key components signals that indeed you and the employer are in accord,” said Mr. Hursh.

But are you really on the same page with your prospective employer? And if you seem to be on the same page, and you sign the LOI, is that a guarantee that the employer will honor its terms?

Not necessarily, according to the experts. In fact, many LOIs contain some verbiage stating that the letter isn’t binding, which can be confusing. Others suggest that it is binding, but the candidate doesn’t realize that the letter isn’t a formal contract and that the contract may contain details not included in the LOI or may omit details mentioned in the LOI, as happened to Ms. Adler’s unfortunate client.

“One of the pitfalls I see is that doctors sign the LOI without recognizing whether it’s binding or nonbinding,” Ms. Murthy said. “If it’s binding, it creates a legal obligation on your part and could preclude you from further negotiation once you see the contract and feel you’d like to negotiate some of its terms.”

Binding letters are typically offered to candidates after some back-and-forth between the parties, and important terms have been agreed to, which can happen either verbally or via e-mail. Once these agreements have been reached, they’re summarized in a “binding” letter before being extended into a full contract.

“But even if you’ve agreed on the terms verbally, it’s still important to have someone more experienced review the offer letter before signing it,” Ms. Murthy said. “It’s important to understand the ‘legalese’ and what your rights and obligations are before agreeing to anything.”

And certainly, if you receive a binding LOI, you shouldn’t sign anything until you’re sure you’re comfortable with its contents and have more details.
 

Are “nonbinding” LOIs really not binding?

Even if the LOI is nonbinding, that doesn’t necessarily mean you can sign it and expect to negotiate later. “I see people tripped up when they sign the LOI, thinking they’ll negotiate later,” said Mr. Hursh. “They may not like the terms – for example, they think the compensation is too low – and they figure they’ll work it out at the contract stage, because the LOI is ‘not legally binding.’ “

But because the candidate signed the LOI, “the employer is under the impression that the compensation was acceptable, so now you’ve tied your hands – and the hands of any attorney you may consult down the road – to negotiate those terms.”

Mr. Hursh said he is often consulted by physicians who signed the contract “to get the ball rolling,” thinking that the LOI was “just a meaningless bureaucratic paper.” They need to understand “that the employer wants to make sure they’re in agreement on the basic points before getting into the details,” he said. “Large hospitals with in-house counsel may not want to use their legal department’s valuable time in redrafting terms they thought were acceptable to the candidate, and most practices don’t want to pay a lawyer to draft an LOI and then come back and say, ‘Actually, the physician wants more compensation.’ “

Mr. Nabity summarized: “The LOI is essentially a negotiation tactic to take some of the cards out of the hands of the doctor and commit him or her to something they’re not ready to commit to.” Employers may be playing on the sense of pressure and candidate’s fear that the job will slip through their fingers if they wait too long to sign. “But it’s better to wait longer at this stage before signing even a nonbinding LOI,” he said.

What to do before signing

So how should physicians relate to the LOI? Mr. Nabity advises “working through the details of the offer letter first, going through it carefully and identifying areas of concern, bearing in mind that employers never begin with their best offer.”

He pointed out that physicians “rarely know their value and usually don’t know how to work through the dynamics of compensation, call schedules, additional incentives, bonuses, and productivity,” so they need to be informed about these areas before signing anything.

Ms. Murthy recommended “going back and saying [to the prospective employer], ‘Thank you, but I need time to consider and evaluate this offer.’ Then, do some due diligence.”

At that point, you can hire an attorney to go over the offer, educate yourself about compensation benchmarks and what your worth actually is, or consult another trained professional or more experienced individual who can review the LOI before you sign it.

That’s what Dominique Cleveland, MD, a Texas-based ob.gyn., did when she received an LOI 5 years ago.

“The offer letter from the group practice contained a statement that the group wanted me to come on board, what the salary would be, and the time frame that would be covered in the contract,” she told this news organization. “It mentioned benefits and incentives and relocation, but it was only a short document – maybe one or two pages long.”

At the time that she received her LOI, Dr. Cleveland was completing her residency. She consulted experienced faculty members from her institution to find out whether the terms laid out in the LOI “were the norm and were reasonable.” She was “fairly certain” that the salary was low and this was confirmed by the faculty members she talked to. “So I felt comfortable asking for more [compensation],” she said.

The employer was receptive to her proposed changes, which were included in the more detailed contract that followed. “I can’t say there were any surprises per se in the contract because I had negotiated my salary after receiving the offer letter,” she said. She accepted the position and has been working there ever since.

Dr. Cleveland advises physicians “not to make a decision without speaking to someone who’s experienced and can help you compare what’s out there.”

She also encourages physicians to ask for what they want, whether it’s compensation or something else, such as call schedule or vacation time, without being afraid. “I’m a firm believer that you won’t know what you can get if you don’t ask for it,” she said.
 

Negotiation tips

Mr. Nabity recommended not agreeing to any terms until you are ready to enter into negotiation, recognizing that negotiation is an “art” that requires skill and training. “Either get trained in negotiation, perhaps taking courses to advocate for yourself – which is rare, and most doctors aren’t likely to do this – or go to a trained advocate, such as a lawyer, who can do so on your behalf.”

You might share your concerns with the person who interviewed you, with the person whose name is on the LOI, or with the recruiter who can advocate on your behalf, Ms. Murthy said. “You can reach out to the recruiter and say, ‘I really appreciate the opportunity, but there are some things in the offer letter I’d like to continue discussing.’ “

When you’re ready to negotiate, be sure to assemble all of your “asks” in a single document rather than going back to the prospective employer with “multiple individual questions multiple times,” Ms. Murthy advised. It’s more efficient and the employer or recruiter will appreciate that.

She also advised couching your request in language that expresses your appreciation for the offer and stating that you would like the agreement to serve the best interests of both parties. “Use open-ended language like that, and ask if it’s all right for you to send back some questions, ask for clarification, or share concerns.”

Most employers “will be fine with that,” Ms. Murthy said. “Most won’t say, ‘This is it, take it or leave it.’ If they do, that’s a red flag for you to reconsider whether you really want to work for this particular employer.”

Mr. Hursh suggested that if you choose to sign the LOI immediately, so as to rapidly let the prospective employer know of your interest, “you should add some type of qualification such as, ‘I’m signing this to express my interest, but accepting the position will be dependent upon a more thorough review of compensation benchmarks,’ for example.”

Mr. Nabity agreed: “You can add a handwritten note to the signed LOI expressing that you’re eager to move forward and proceed with the position, but it shouldn’t be construed as accepting the terms of the LOI until you’ve seen the full contract.

“Remember, health care can’t exist without doctors,” Mr. Nabity said. “Doctors are the star players and should go into the negotiation process recognizing their true worth.”
 

A version of this article appeared on Medscape.com.

You’ve just received an offer letter from that job you interviewed for. Sometimes you want to let the employer know right away how interested you are. The verbiage says the letter isn’t “binding.” So you eagerly sign on the dotted line. Everything looks great ... until it isn’t.

Attorney Ericka Adler, JD, LLM, a partner at Roetzel & Andress, a Chicago-based law firm that represents physicians and health care professionals nationwide, described her client who was in this predicament. The physician, a dermatologist, left a practice where she had been employed because she had received an “amazing” offer letter that included promises about her new work location, staffing, equipment, and hours. She signed and immediately gave notice to her previous employer.

“When she received the actual employment contract, none of those details from the offer letter – which is also called a letter of intent [LOI] – were included,” Ms. Adler told this news organization. The physician wanted to have the details from the LOI formally spelled out in the contract, but the employer refused.

“Basically, they said, ‘This is our standard contract and you’ll just have to trust us that we’ll keep our word. We meant what we said in the LOI, but we cannot include those details in the actual agreement because everyone has the same form of agreement.’ “ The physician decided to sign the contract and accept the position.

She contacted Ms. Adler after she had been at her new position for a month. “She had received none of the things they had promised her in the LOI,” Ms. Adler reported. “She lacked the NP and PA support, she lacked the equipment, she didn’t have enough exam rooms. As soon as she started, someone with whom she was sharing call coverage left, and she was expected to take over. The LOI had a cap on the amount of call she would be required to take, but that verbiage didn’t make it into the contract.”

Ms. Adler tried to address this issue with the employer. “We couldn’t say they had literally breached the agreement, but we did list the things that were mentioned in the LOI but on which they hadn’t delivered. We asked them to fix the issue within 10 days.”

The employer argued “that they didn’t have to fulfill anything that wasn’t spelled out in the contract, even if it was in the LOI. In fact, the contract specified clearly that the signed employment agreement was the only agreement and replaced any previous written or oral agreements between the parties.”

The dermatologist ultimately left the new position. “She might have been able to have a legal claim against the employer for breach or perhaps ‘detrimental reliance’ – meaning, she might have argued that she had been financially harmed due to the false promises made to her. But it would have been difficult and expensive for her to litigate the issue,” said Ms. Adler.

“It also didn’t seem like the physician could remain in the job and develop a positive work relationship with the employer, given that she felt betrayed and misled, and didn’t like the terms of employment, which didn’t match her needs or expectations,” said Ms. Adler.

She added that “most employers are not as unscrupulous and dishonest as this one was. But some employers do play on the fact that younger doctors – especially residents and fellows – tend to be trusting or feel they don’t have negotiation power. They’re often excited to get an offer and sign it without a second thought.”

That’s why she advises physicians to “review the terms of the LOI carefully and make sure you’re comfortable with them before signing it; but know that the real contract to negotiate will be the actual Employment Agreement.”

She also advises physicians not to give notice at their current place of employment until they’ve signed the final contract with the new employer.
 

On the same page?

Anu Murthy, JD, an attorney and associate contract review specialist at Contract Diagnostics, explained that the LOI is a document that the candidate receives after an interview but before a full contract. Sometimes, the LOI is preceded by a verbal or e-mailed offer, which is less formal.

“An LOI is sometimes called a Term Sheet or Memorandum of Understanding,“ Ms. Murthy told this news organization. “Typically, it lays out key provisions, such as compensation, initial term of the contract, location, and recruitment incentives.” Sometimes it includes mention of staffing, call schedule, malpractice, noncompete covenants, and other components of the position.

Justin Nabity, founder and CEO of Physicians Thrive, a physician financial advisory group, said that LOIs are “a way for employers to gauge a prospective employee’s level of interest.”

The employer “doesn’t want to send a contract with a lot of details before determining whether the candidate is really serious about the position, so the offer letter doesn’t show the whole picture,” Mr. Nabity told this news organization.

Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, agreed.

“Another way of putting it is that the employer wants to see whether the prospective employee is on the same page. The LOI will typically include some key components that will later appear in a more complete and formal contract, together with other topics and details. Agreeing to those key components signals that indeed you and the employer are in accord,” said Mr. Hursh.

But are you really on the same page with your prospective employer? And if you seem to be on the same page, and you sign the LOI, is that a guarantee that the employer will honor its terms?

Not necessarily, according to the experts. In fact, many LOIs contain some verbiage stating that the letter isn’t binding, which can be confusing. Others suggest that it is binding, but the candidate doesn’t realize that the letter isn’t a formal contract and that the contract may contain details not included in the LOI or may omit details mentioned in the LOI, as happened to Ms. Adler’s unfortunate client.

“One of the pitfalls I see is that doctors sign the LOI without recognizing whether it’s binding or nonbinding,” Ms. Murthy said. “If it’s binding, it creates a legal obligation on your part and could preclude you from further negotiation once you see the contract and feel you’d like to negotiate some of its terms.”

Binding letters are typically offered to candidates after some back-and-forth between the parties, and important terms have been agreed to, which can happen either verbally or via e-mail. Once these agreements have been reached, they’re summarized in a “binding” letter before being extended into a full contract.

“But even if you’ve agreed on the terms verbally, it’s still important to have someone more experienced review the offer letter before signing it,” Ms. Murthy said. “It’s important to understand the ‘legalese’ and what your rights and obligations are before agreeing to anything.”

And certainly, if you receive a binding LOI, you shouldn’t sign anything until you’re sure you’re comfortable with its contents and have more details.
 

Are “nonbinding” LOIs really not binding?

Even if the LOI is nonbinding, that doesn’t necessarily mean you can sign it and expect to negotiate later. “I see people tripped up when they sign the LOI, thinking they’ll negotiate later,” said Mr. Hursh. “They may not like the terms – for example, they think the compensation is too low – and they figure they’ll work it out at the contract stage, because the LOI is ‘not legally binding.’ “

But because the candidate signed the LOI, “the employer is under the impression that the compensation was acceptable, so now you’ve tied your hands – and the hands of any attorney you may consult down the road – to negotiate those terms.”

Mr. Hursh said he is often consulted by physicians who signed the contract “to get the ball rolling,” thinking that the LOI was “just a meaningless bureaucratic paper.” They need to understand “that the employer wants to make sure they’re in agreement on the basic points before getting into the details,” he said. “Large hospitals with in-house counsel may not want to use their legal department’s valuable time in redrafting terms they thought were acceptable to the candidate, and most practices don’t want to pay a lawyer to draft an LOI and then come back and say, ‘Actually, the physician wants more compensation.’ “

Mr. Nabity summarized: “The LOI is essentially a negotiation tactic to take some of the cards out of the hands of the doctor and commit him or her to something they’re not ready to commit to.” Employers may be playing on the sense of pressure and candidate’s fear that the job will slip through their fingers if they wait too long to sign. “But it’s better to wait longer at this stage before signing even a nonbinding LOI,” he said.

What to do before signing

So how should physicians relate to the LOI? Mr. Nabity advises “working through the details of the offer letter first, going through it carefully and identifying areas of concern, bearing in mind that employers never begin with their best offer.”

He pointed out that physicians “rarely know their value and usually don’t know how to work through the dynamics of compensation, call schedules, additional incentives, bonuses, and productivity,” so they need to be informed about these areas before signing anything.

Ms. Murthy recommended “going back and saying [to the prospective employer], ‘Thank you, but I need time to consider and evaluate this offer.’ Then, do some due diligence.”

At that point, you can hire an attorney to go over the offer, educate yourself about compensation benchmarks and what your worth actually is, or consult another trained professional or more experienced individual who can review the LOI before you sign it.

That’s what Dominique Cleveland, MD, a Texas-based ob.gyn., did when she received an LOI 5 years ago.

“The offer letter from the group practice contained a statement that the group wanted me to come on board, what the salary would be, and the time frame that would be covered in the contract,” she told this news organization. “It mentioned benefits and incentives and relocation, but it was only a short document – maybe one or two pages long.”

At the time that she received her LOI, Dr. Cleveland was completing her residency. She consulted experienced faculty members from her institution to find out whether the terms laid out in the LOI “were the norm and were reasonable.” She was “fairly certain” that the salary was low and this was confirmed by the faculty members she talked to. “So I felt comfortable asking for more [compensation],” she said.

The employer was receptive to her proposed changes, which were included in the more detailed contract that followed. “I can’t say there were any surprises per se in the contract because I had negotiated my salary after receiving the offer letter,” she said. She accepted the position and has been working there ever since.

Dr. Cleveland advises physicians “not to make a decision without speaking to someone who’s experienced and can help you compare what’s out there.”

She also encourages physicians to ask for what they want, whether it’s compensation or something else, such as call schedule or vacation time, without being afraid. “I’m a firm believer that you won’t know what you can get if you don’t ask for it,” she said.
 

Negotiation tips

Mr. Nabity recommended not agreeing to any terms until you are ready to enter into negotiation, recognizing that negotiation is an “art” that requires skill and training. “Either get trained in negotiation, perhaps taking courses to advocate for yourself – which is rare, and most doctors aren’t likely to do this – or go to a trained advocate, such as a lawyer, who can do so on your behalf.”

You might share your concerns with the person who interviewed you, with the person whose name is on the LOI, or with the recruiter who can advocate on your behalf, Ms. Murthy said. “You can reach out to the recruiter and say, ‘I really appreciate the opportunity, but there are some things in the offer letter I’d like to continue discussing.’ “

When you’re ready to negotiate, be sure to assemble all of your “asks” in a single document rather than going back to the prospective employer with “multiple individual questions multiple times,” Ms. Murthy advised. It’s more efficient and the employer or recruiter will appreciate that.

She also advised couching your request in language that expresses your appreciation for the offer and stating that you would like the agreement to serve the best interests of both parties. “Use open-ended language like that, and ask if it’s all right for you to send back some questions, ask for clarification, or share concerns.”

Most employers “will be fine with that,” Ms. Murthy said. “Most won’t say, ‘This is it, take it or leave it.’ If they do, that’s a red flag for you to reconsider whether you really want to work for this particular employer.”

Mr. Hursh suggested that if you choose to sign the LOI immediately, so as to rapidly let the prospective employer know of your interest, “you should add some type of qualification such as, ‘I’m signing this to express my interest, but accepting the position will be dependent upon a more thorough review of compensation benchmarks,’ for example.”

Mr. Nabity agreed: “You can add a handwritten note to the signed LOI expressing that you’re eager to move forward and proceed with the position, but it shouldn’t be construed as accepting the terms of the LOI until you’ve seen the full contract.

“Remember, health care can’t exist without doctors,” Mr. Nabity said. “Doctors are the star players and should go into the negotiation process recognizing their true worth.”
 

A version of this article appeared on Medscape.com.

For adolescents with migraine or other recurring types of headaches, planning and structuring a transition from pediatric to adult health services is recommended for a potential of better outcomes, according to a headache specialist who treats adults and children and spoke at the 2023 Scottsdale Headache Symposium.

“I would start at about the age of 15 or 16,” said Hope L. O’Brien, MD, Headache Center of Hope, University of Cincinnati.

Describing the steps that she thinks should be included in an effective transition, Dr. O’Brien maintained, “you will have a greater chance of successful transition and lessen the likelihood of the chronicity and the poor outcomes that we see in adults.”

Dr. O’Brien, who developed a headache clinic that serves individuals between the ages of 15 and 27, has substantial experience with headache patients in this age range. She acknowledged that there are no guideline recommendations for how best to guide the transition from pediatric to adult care, but she has developed some strategies at her own institution, including a tool for determining when the transition should be considered.

“Transition readiness is something that you need to think about,” she said. “You don’t just do it [automatically] at the age of 18.”
 

TRAQ questionnaire is helpful

The Transition Readiness Assessment Questionnaire (TRAQ) is one tool that can be helpful, according to Dr. O’Brien, This tool, which can be used to evaluate whether young patients feel prepared to describe their own health status and needs and advocate on their own behalf, is not specific to headache, but the principle is particularly important in headache because of the importance of the patient’s history. Dr. O’Brien said that a fellow in her program, Allyson Bazarsky, MD, who is now affiliated with the University of Vermont Medical Center, Burlington, validated TRAQ for headache about 6 years ago.

“TRAQ is available online. It’s free. You can download it as a PDF,” Dr. O’Brien said. In fact, several age-specific versions can now be found readily on a web search for TRAQ questionnaire.

Ultimately, TRAQ helps the clinician to gauge what patients know about their disease, the medications they are taking, and the relevance of any comorbidities, such as mood disorders. It also provides insight about the ability to understand their health issues and to communicate well with caregivers.

Dr. O’Brien sees this as a process over time, rather than something to be implemented a few months before the transition.

“It is important to start making the shift during childhood and talking directly to the child,” Dr. O’Brien said. If education about the disease and its triggers are started relatively early in adolescence, the transition will not only be easier, but patients might have a chance to understand and control their disease at an earlier age.

With this kind of approach, most children are at least in the preparation stage by age 18 years. However, the age at which patients are suitable for transition varies substantially. Many patients 18 years of age or older are in the “action phase,” meaning it is time to take steps to transition.

Again, based on the interrelationship between headache and comorbidities, particularly mood disorders, such as depression and anxiety, the goal should not be limited to headache. Young adults should be educated about taking responsibility for their overall health.

In addition to educating the patient, Dr. O’Brien recommended preparing a transfer packet, such as the one described in an article published in Headache. Geared for communicating with the clinician who will take over care, the contents should include a detailed medical history along with the current treatment plan and list of medications that have been effective and those that have failed, according to Dr. O’Brien.

“An emergency plan in the form of an emergency department letter in case the patient needs to seek emergent care at an outside facility” is also appropriate, Dr. O’Brien said.

The patient should be aware of what is in the transfer pack in order to participate in an informed discussion of health care with the adult neurologist.
 

Poor transition linked to poor outcomes

A substantial proportion of adolescents with migraine continue to experience episodes as an adult, particularly those with a delayed diagnosis of migraine, those with a first degree relative who has migraine, and those with poor health habits, but this is not inevitable. Dr. O’Brien noted that “unsuccessful transition of care” into adulthood is a factor associated with poorer outcomes, making it an appropriate target for optimizing outcomes.

“Have that discussion on transfer of care with an action plan and do that early, especially in those with chronic or persistent disability headaches,” Dr. O’Brien emphasized.

This is pertinent advice, according to Amy A. Gelfand, MD, director of the child and adolescent headache program at Benioff Children’s Hospitals, University of California, San Francisco. Senior author of a comprehensive review article on pediatric migraine in Neurologic Clinics, Dr. Gelfand said the practical value of young adults learning what medications they are taking, and why, can place them in a better position to monitor their disease and to understand when a clinical visit is appropriate.

“I agree that it is important to help young adults (i.e., 18- or 19-year-olds) to prepare for the transition from the pediatric health care environment to the adult one,” said Dr. Gelfand, who has written frequently on this and related topics, such as the impact of comorbidities on outcome.

Dr. O’Brien reports financial relationships with AbbVie, Eli Lilly, Guidepoint, Pfizer, and Vector Psychometric Group. Dr. Gelfand reports financial relationships with Allergan, Eli Lilly, EMKinetics, eNeura, Teva and Zosano.

For adolescents with migraine or other recurring types of headaches, planning and structuring a transition from pediatric to adult health services is recommended for a potential of better outcomes, according to a headache specialist who treats adults and children and spoke at the 2023 Scottsdale Headache Symposium.

“I would start at about the age of 15 or 16,” said Hope L. O’Brien, MD, Headache Center of Hope, University of Cincinnati.

Describing the steps that she thinks should be included in an effective transition, Dr. O’Brien maintained, “you will have a greater chance of successful transition and lessen the likelihood of the chronicity and the poor outcomes that we see in adults.”

Dr. O’Brien, who developed a headache clinic that serves individuals between the ages of 15 and 27, has substantial experience with headache patients in this age range. She acknowledged that there are no guideline recommendations for how best to guide the transition from pediatric to adult care, but she has developed some strategies at her own institution, including a tool for determining when the transition should be considered.

“Transition readiness is something that you need to think about,” she said. “You don’t just do it [automatically] at the age of 18.”
 

TRAQ questionnaire is helpful

The Transition Readiness Assessment Questionnaire (TRAQ) is one tool that can be helpful, according to Dr. O’Brien, This tool, which can be used to evaluate whether young patients feel prepared to describe their own health status and needs and advocate on their own behalf, is not specific to headache, but the principle is particularly important in headache because of the importance of the patient’s history. Dr. O’Brien said that a fellow in her program, Allyson Bazarsky, MD, who is now affiliated with the University of Vermont Medical Center, Burlington, validated TRAQ for headache about 6 years ago.

“TRAQ is available online. It’s free. You can download it as a PDF,” Dr. O’Brien said. In fact, several age-specific versions can now be found readily on a web search for TRAQ questionnaire.

Ultimately, TRAQ helps the clinician to gauge what patients know about their disease, the medications they are taking, and the relevance of any comorbidities, such as mood disorders. It also provides insight about the ability to understand their health issues and to communicate well with caregivers.

Dr. O’Brien sees this as a process over time, rather than something to be implemented a few months before the transition.

“It is important to start making the shift during childhood and talking directly to the child,” Dr. O’Brien said. If education about the disease and its triggers are started relatively early in adolescence, the transition will not only be easier, but patients might have a chance to understand and control their disease at an earlier age.

With this kind of approach, most children are at least in the preparation stage by age 18 years. However, the age at which patients are suitable for transition varies substantially. Many patients 18 years of age or older are in the “action phase,” meaning it is time to take steps to transition.

Again, based on the interrelationship between headache and comorbidities, particularly mood disorders, such as depression and anxiety, the goal should not be limited to headache. Young adults should be educated about taking responsibility for their overall health.

In addition to educating the patient, Dr. O’Brien recommended preparing a transfer packet, such as the one described in an article published in Headache. Geared for communicating with the clinician who will take over care, the contents should include a detailed medical history along with the current treatment plan and list of medications that have been effective and those that have failed, according to Dr. O’Brien.

“An emergency plan in the form of an emergency department letter in case the patient needs to seek emergent care at an outside facility” is also appropriate, Dr. O’Brien said.

The patient should be aware of what is in the transfer pack in order to participate in an informed discussion of health care with the adult neurologist.
 

Poor transition linked to poor outcomes

A substantial proportion of adolescents with migraine continue to experience episodes as an adult, particularly those with a delayed diagnosis of migraine, those with a first degree relative who has migraine, and those with poor health habits, but this is not inevitable. Dr. O’Brien noted that “unsuccessful transition of care” into adulthood is a factor associated with poorer outcomes, making it an appropriate target for optimizing outcomes.

“Have that discussion on transfer of care with an action plan and do that early, especially in those with chronic or persistent disability headaches,” Dr. O’Brien emphasized.

This is pertinent advice, according to Amy A. Gelfand, MD, director of the child and adolescent headache program at Benioff Children’s Hospitals, University of California, San Francisco. Senior author of a comprehensive review article on pediatric migraine in Neurologic Clinics, Dr. Gelfand said the practical value of young adults learning what medications they are taking, and why, can place them in a better position to monitor their disease and to understand when a clinical visit is appropriate.

“I agree that it is important to help young adults (i.e., 18- or 19-year-olds) to prepare for the transition from the pediatric health care environment to the adult one,” said Dr. Gelfand, who has written frequently on this and related topics, such as the impact of comorbidities on outcome.

Dr. O’Brien reports financial relationships with AbbVie, Eli Lilly, Guidepoint, Pfizer, and Vector Psychometric Group. Dr. Gelfand reports financial relationships with Allergan, Eli Lilly, EMKinetics, eNeura, Teva and Zosano.

For adolescents with migraine or other recurring types of headaches, planning and structuring a transition from pediatric to adult health services is recommended for a potential of better outcomes, according to a headache specialist who treats adults and children and spoke at the 2023 Scottsdale Headache Symposium.

“I would start at about the age of 15 or 16,” said Hope L. O’Brien, MD, Headache Center of Hope, University of Cincinnati.

Describing the steps that she thinks should be included in an effective transition, Dr. O’Brien maintained, “you will have a greater chance of successful transition and lessen the likelihood of the chronicity and the poor outcomes that we see in adults.”

Dr. O’Brien, who developed a headache clinic that serves individuals between the ages of 15 and 27, has substantial experience with headache patients in this age range. She acknowledged that there are no guideline recommendations for how best to guide the transition from pediatric to adult care, but she has developed some strategies at her own institution, including a tool for determining when the transition should be considered.

“Transition readiness is something that you need to think about,” she said. “You don’t just do it [automatically] at the age of 18.”
 

TRAQ questionnaire is helpful

The Transition Readiness Assessment Questionnaire (TRAQ) is one tool that can be helpful, according to Dr. O’Brien, This tool, which can be used to evaluate whether young patients feel prepared to describe their own health status and needs and advocate on their own behalf, is not specific to headache, but the principle is particularly important in headache because of the importance of the patient’s history. Dr. O’Brien said that a fellow in her program, Allyson Bazarsky, MD, who is now affiliated with the University of Vermont Medical Center, Burlington, validated TRAQ for headache about 6 years ago.

“TRAQ is available online. It’s free. You can download it as a PDF,” Dr. O’Brien said. In fact, several age-specific versions can now be found readily on a web search for TRAQ questionnaire.

Ultimately, TRAQ helps the clinician to gauge what patients know about their disease, the medications they are taking, and the relevance of any comorbidities, such as mood disorders. It also provides insight about the ability to understand their health issues and to communicate well with caregivers.

Dr. O’Brien sees this as a process over time, rather than something to be implemented a few months before the transition.

“It is important to start making the shift during childhood and talking directly to the child,” Dr. O’Brien said. If education about the disease and its triggers are started relatively early in adolescence, the transition will not only be easier, but patients might have a chance to understand and control their disease at an earlier age.

With this kind of approach, most children are at least in the preparation stage by age 18 years. However, the age at which patients are suitable for transition varies substantially. Many patients 18 years of age or older are in the “action phase,” meaning it is time to take steps to transition.

Again, based on the interrelationship between headache and comorbidities, particularly mood disorders, such as depression and anxiety, the goal should not be limited to headache. Young adults should be educated about taking responsibility for their overall health.

In addition to educating the patient, Dr. O’Brien recommended preparing a transfer packet, such as the one described in an article published in Headache. Geared for communicating with the clinician who will take over care, the contents should include a detailed medical history along with the current treatment plan and list of medications that have been effective and those that have failed, according to Dr. O’Brien.

“An emergency plan in the form of an emergency department letter in case the patient needs to seek emergent care at an outside facility” is also appropriate, Dr. O’Brien said.

The patient should be aware of what is in the transfer pack in order to participate in an informed discussion of health care with the adult neurologist.
 

Poor transition linked to poor outcomes

A substantial proportion of adolescents with migraine continue to experience episodes as an adult, particularly those with a delayed diagnosis of migraine, those with a first degree relative who has migraine, and those with poor health habits, but this is not inevitable. Dr. O’Brien noted that “unsuccessful transition of care” into adulthood is a factor associated with poorer outcomes, making it an appropriate target for optimizing outcomes.

“Have that discussion on transfer of care with an action plan and do that early, especially in those with chronic or persistent disability headaches,” Dr. O’Brien emphasized.

This is pertinent advice, according to Amy A. Gelfand, MD, director of the child and adolescent headache program at Benioff Children’s Hospitals, University of California, San Francisco. Senior author of a comprehensive review article on pediatric migraine in Neurologic Clinics, Dr. Gelfand said the practical value of young adults learning what medications they are taking, and why, can place them in a better position to monitor their disease and to understand when a clinical visit is appropriate.

“I agree that it is important to help young adults (i.e., 18- or 19-year-olds) to prepare for the transition from the pediatric health care environment to the adult one,” said Dr. Gelfand, who has written frequently on this and related topics, such as the impact of comorbidities on outcome.

Dr. O’Brien reports financial relationships with AbbVie, Eli Lilly, Guidepoint, Pfizer, and Vector Psychometric Group. Dr. Gelfand reports financial relationships with Allergan, Eli Lilly, EMKinetics, eNeura, Teva and Zosano.