Autism spectrum disorder (ASD) is characterized by persistent deficits in social communication and social interaction, including deficits in social reciprocity, nonverbal communicative behaviors used for social interaction, and skills in developing, maintaining, and understanding relationships.¹ In addition, the diagnosis of ASD requires the presence of restricted, repetitive patterns of behavior, interests, or activities.

Initially, ASD was considered a rare condition. In recent years, the reported prevalence has increased substantially. The most recent estimated prevalence is 1 in 68 children at age 8, with a male-to-female ratio of 4 to 1.²

Behavioral interventions are considered to be the most effective treatment for the core symptoms of ASD. Pharmacologic interventions are used primarily to treat associated or comorbid symptoms rather than the core symptoms. Aggression, self-injurious behavior, and irritability are common targets of pharmacotherapy in patients with ASD. Studies have provided support for the use of antipsychotic agents to treat irritability and associated aggressive behaviors in patients with autism,³ but because these agents have significant adverse effects—including extrapyramidal side effects, somnolence, and weight gain—their use requires a careful risk/benefit assessment. Stimulants have also been shown to be effective in treating comorbid attention-deficit/hyperactivity symptoms. The use of selective serotonin reuptake inhibitors (SSRIs) to manage repetitive behaviors and anxiety is also common.

Here, we review 7 recent studies of the pharmacologic management of ASD (Table).^4-10 These studies examined the role of SSRIs (sertraline, fluoxetine), an acetylcholinesterase inhibitor (donepezil), atypical antipsychotics (risperidone, aripiprazole, lurasidone), natural supplements (vitamin D, omega-3), a diuretic (bumetanide), and a glutamatergic modulator (riluzole) in the treatment of ASD symptoms.

1. Potter LA, Scholze DA, Biag HMB, et al. A randomized controlled trial of sertraline in young children with autism spectrum disorder. Front Psychiatry. 2019;10:810.

Several studies have shown that SSRIs improve language development in children with Fragile X syndrome, based on the Mullen Scales of Early Learning (MSEL). A previously published trial involving children with Fragile X syndrome and comorbid ASD found that sertraline improved expressive language development. Potter et al⁴ examined the role of sertraline in children with ASD only.

Study Design

• In this randomized, double-blind, placebo-controlled trial, 58 children age 24 to 72 months with ASD received low-dose sertraline or placebo for 6 months.
• Of the 179 participants who were screened for eligibility, 58 were included in the study. Of these 58 participants, 32 received sertraline and 26 received placebo. The numbers of participants who discontinued from the sertraline and placebo arms were 8 and 5, respectively.
• Among those in the sertraline group, participants age <48 months received 2.5 mg/d, and those age ≥48 months received 5 mg/d.

Outcomes

• No significant differences were found on the primary outcome (MSEL expressive language raw score and age-equivalent combined score) or secondary outcomes (including Clinical Global Impressions–Improvement [CGI-I] scale at 3 months and end of treatment), as per intent-to-treat analyses.
• Sertraline was well tolerated. There was no difference in adverse effects between treatment groups and no serious adverse events.

Conclusion

• Although potentially useful for language development in patients with Fragile X syndrome with comorbid ASD, SSRIs such as sertraline have not proven efficacious for improving expressive language in patients with non-syndromic ASD.
• While 6-month treatment with low-dose sertraline in young children with ASD appears safe, the long-term effects are unknown.

Continue to: Gabis et al⁵ examined the safety...

2. Gabis LV, Ben-Hur R, Shefer S, et al. Improvement of language in children with autism with combined donepezil and choline treatment. J Mol Neurosci. 2019;69(2):224-234.

Gabis et al⁵ examined the safety and efficacy of utilizing donepezil, an acetylcholinesterase inhibitor, plus a choline supplement to treat both core features and associated symptoms in children and adolescents with ASD.

Study design

• This 9-month randomized, double-blind trial included 60 children/adolescents with ASD who were randomly assigned to receive placebo or donepezil plus a choline supplement. Participants underwent a baseline evaluation (E1), 12 weeks of treatment and re-evaluation (E2), 6 months of washout, and a final evaluation (E3).
• The baseline and final evaluations assessed changes in language performance, adaptive functioning, sleep habits, autism severity, clinical impression, and intellectual abilities. The evaluation after 12 weeks of treatment (E2) included all of these measures except intellectual abilities.

Outcomes

• Patients treated with donepezil plus a choline supplement had significant improvement in receptive language skills between E1 and E3 (P = .003).
• Patients treated with donepezil plus a choline supplement had significant worsening in scores on the Autism Treatment Evaluation Checklist (ATEC) health/physical behavior subscale between E1 and E2 (P = .012) and between E1 and E3 (P = .021).
• Improvement in receptive language skills was significant only in patients age 5 to 10 years (P = .047), whereas worsening in ATEC health/physical behavior subscale score was significant only in patients age 10 to 16 years (P = .024).
• Patients treated with donepezil plus a choline supplement reported higher percentages of gastrointestinal disturbance when compared with placebo (P = .007), and patients in the adolescent subgroup had a significant increase in irritability (P = .035).

Conclusion

• Patients age 5 to 10 years treated with donepezil plus a choline supplement exhibited improved receptive language skills. This treatment was less effective in patients age >10 years, and this group also exhibited behavioral worsening.
• Gastrointestinal disturbances were the main adverse effect of treatment with donepezil plus a choline supplement.

Continue to: The persistence of excitatory...

3. James BJ, Gales MA, Gales BJ. Bumetanide for autism spectrum disorder in children: a review of randomized controlled trials. Ann Pharmacother. 2019;53(5):537-544.

The persistence of excitatory gamma-aminobutyric acid (GABA) signaling has been found in patients with ASD. Bumetanide is a sodium-potassium-chloride cotransporter 1 (NKCC1) antagonist that not only decreases intracellular chloride, but also aberrantly decreases GABA signaling. This potent loop diuretic is a proposed treatment for symptoms of ASD. James et al⁶ evaluated the safety and efficacy of bumetanide use in children with ASD.
 

Study design

• Researchers searched the PubMed and Ovid MEDLINE databases for the terms “autism” and “bumetanide” between 1946 and 2018. A total of 26 articles were screened by title, 7 were screened by full text, and 3 articles were included in the study. The remaining articles were excluded due to study design and use of non-human subjects.
• All 3 randomized controlled trials evaluated the effects of low-dose oral bumetanide (most common dose was 0.5 mg twice daily) in a total of 208 patients age 2 to 18 years.
• Measurement scales used in the 3 studies included the Childhood Autism Rating Scale (CARS), Clinical Global Impressions Scale (CGI), Autism Behavioral Checklist (ABC), Social Responsiveness Scale (SRS), and Autism Diagnostic Observation Schedule-Generic (ADOS-G).

Outcomes

• Bumetanide improved scores on multiple autism assessment scales, including CARS, but the degree of improvement was not consistent across the 3 trials.
• There was a statistically significant improvement in ASD symptoms as measured by CGI in all 3 trials, and statistically significant improvements on the ABC and SRS in 2 trials. No improvements were noted on the ADOS-G in any of the trials.
• No dose-effect correlation was identified, but hypokalemia and polyuria were more prevalent with higher doses of bumetanide.

Conclusion

• Low-dose oral bumetanide improved social communication, social interactions, and restricted interests in patients with moderate to severe ASD. However, the 3 trials used different evaluation methods and observed varying degrees of improvement, which makes it difficult to make recommendations for or against the use of bumetanide.
• Streamlined trials with a consensus on evaluation methodology are needed to draw conclusions about the efficacy and safety of bumetanide as a treatment for ASD.

Continue to: The use of SSRIs to target...

4. Li C, Bai Y, Jin C, et al. Efficacy and safety of fluoxetine in autism spectrum disorder: a meta-analysis. Am J Ther. 2020;27(3):e312-e315.

The use of SSRIs to target symptoms of ASD has been long studied because many children with ASD have elevated serotonin levels. Several SSRIs, including fluoxetine, are FDA-approved for the treatment of obsessive-compulsive disorder, anxiety, and depression. Currently, no SSRIs are FDA-approved for treating ASD. In a meta-analysis, Li et al⁷ evaluated the use of fluoxetine for ASD.
 

Study design

• Two independent researchers searched for studies of fluoxetine treatment for ASD in Embase, Google Scholar, Ovid SP, and PubMed, with disagreement resolved by consensus.
• The researchers extracted the study design, patient demographics, and outcomes (inter-rater reliability kappa = 0.93). The primary outcomes were response rate of patients treated with fluoxetine, and change from baseline in ABC, ATEC, CARS, CGI, and Yale-Brown Obsessive Compulsive Scale (Y-BOCS) scores after fluoxetine treatment.

Outcomes

• This meta-analysis included 13 studies in which fluoxetine was used to treat a total of 303 patients with ASD. The median treatment duration was 6 months, the average age of participants was 15.23 years, and most participants (72%) were male.
• The response rate of patients treated with fluoxetine was 75%, with significant mean changes from baseline in ABC score (Helvetica Neue LT Std−3.42), ATEC score (Helvetica Neue LT Std−2.04), CGI score (Helvetica Neue LT Std−0.93), and Y-BOCS score (Helvetica Neue LT Std−1.86).
• A significantly higher incidence of hyperactivity/restlessness/agitation was noted with fluoxetine.

Conclusion

• Although 75% of participants re­sponded to fluoxetine, the limitations of this meta-analysis included low power, inadequate quality of the included studies, and high statistical heterogeneity. In addition, the analysis found a high incidence of hyperactivity/restlessness associated with fluoxetine.
• Future randomized controlled studies may provide further clarification on managing symptoms of ASD with SSRIs.

Continue to: Irritability is a common comorbid...

5. Fallah MS, Shaikh MR, Neupane B, et al. Atypical antipsychotics for irritability in pediatric autism: a systematic review and network meta-analysis. J Child Adolesc Psychopharmacol. 2019;29(3):168-180.

Irritability is a common comorbid symptom in children with ASD. Two second-generation antipsychotics (SGAs)—risperidone and aripiprazole—are FDA-approved for irritability associated with ASD. Fallah et al⁸ examined the efficacy of several SGAs for treating irritability.

Study design

• This review and meta-analysis included 8 studies identified from Medline, PsycINFO, and Embase from inception to March 2018. It included double-blind, randomized controlled trials that used the Aberrant Behavior Checklist Irritability (ABC-I) to measure irritability.
• The main outcome was change in degree of irritability.
• The 8 studies compared the efficacy of risperidone, aripiprazole, lurasidone, and placebo in a total of 878 patients.

Outcomes

• Risperidone reduced ABC-I scores more than aripiprazole, lurasidone, or placebo.
• Mean differences in ABC-I scores were Helvetica Neue LT Std−6.89 for risperidone, Helvetica Neue LT Std−6.62 for aripiprazole, and Helvetica Neue LT Std−1.61 for lurasidone.

Conclusion

• Risperidone and aripiprazole were efficacious and safe for children with ASD-associated irritability.
• Lurasidone may minimally improve irritability in children with ASD.

Continue to: Irritability and hyperactivity are common...

6. Mazahery H, Conlon CA, Beck KL, et al. A randomised controlled trial of vitamin D and omega-3 long chain polyunsaturated fatty acids in the treatment of irritability and hyperactivity among children with autism spectrum disorder. J Steroid Biochem Mol Biol. 2019;187:9-16.

Irritability and hyperactivity are common comorbid symptoms in children with ASD and have been linked to lower quality of life, poor adaptive functioning, and lower responsiveness to treatments when compared to children without comorbid problem behaviors. Mazahery et al⁹ evaluated the efficacy of vitamin D, omega-3 long-chain polyunsaturated fatty acids (LCPUFA), or both on irritability and hyperactivity.

Study design

• In a 1-year, double-blind, placebo-controlled trial, 73 children age 2.5 to 8 years with ASD were randomly assigned to receive placebo; vitamin D, 2000 IU/d (VID); omega-3 LCPUFA, 722 mg/d (OM); or both in the aforementioned doses.
• The primary outcome was reduction in the Aberrant Behavior Checklist in the domains of irritability and hyperactivity. Caregivers also completed weekly surveys regarding adverse events, compliance, and utilization of behavioral therapies.
• Of 111 children enrolled, 73 completed the 12 months of treatment.

Outcomes

• Children who received OM and VID had a greater reduction in irritability than those who received placebo (P = .001 and P = .01, respectively).
• Children who received VID also had a reduction in irritability (P = .047).
• An explanatory analysis revealed that OM also reduced lethargy (based on the Aberrant Behavior Checklist) more significantly than placebo (P = .02 adjusted for covariates).

Conclusion

• Treatment with vitamin D, 2000 IU/d, reduced irritability and hyperactivity.
• Treatment with omega-3 LCPUFA, 722 mg/d, reduced hyperactivity and lethargy.

Continue to: Glutamatergic dysregulation has been...

7. Wink LK, Adams R, Horn PS, et al. A randomized placebo-controlled cross-over pilot study of riluzole for drug-refractory irritability in autism spectrum disorder. J Autism Dev Disord. 2018;48(9):3051-3060.

Glutamatergic dysregulation has been identified as a potential cause of ASD. Riluzole, a glutamatergic modulator that is FDA-approved for treating amyotrophic lateral sclerosis, is a drug of interest for the treatment of ASD-related irritability due to this proposed mechanism. Wink et al¹⁰ evaluated riluzole for irritability in patients with ASD.

Study design

• This randomized, double-blind, placebo-controlled, crossover pilot study evaluated the tolerability and safety of adjunctive riluzole treatment for drug-refractory irritability in 8 patients with ASD.
• Participants were age 12 to 25 years, had a diagnosis of ASD confirmed by the autism diagnostic observation schedule 2, and an ABC-I subscale score ≥18. Participants receiving ≥2 psychotropic medications or glutamatergic/GABA-modulating medications were excluded.
• Participants received either 5 weeks of riluzole followed by 5 weeks of placebo, or vice versa; both groups then had a 2-week washout period.
• Riluzole was started at 50 mg/d, and then increased in 50 mg/d–increments to a maximum of 200 mg/d by Week 4.
• Primary outcome measures were change in score on the ABC-I and CGI-I.

Outcomes

• No significant treatment effects were identified.
• All participants tolerated riluzole, 200 mg/d, but increased dosages did not result in a higher overall treatment effect.
• There were no clinically significant adverse effects or laboratory abnormalities.

Conclusion

• Riluzole, 200 mg/d, was well tolerated but had no significant effect on irritability in adolescents with ASD.

Autism spectrum disorder (ASD) is characterized by persistent deficits in social communication and social interaction, including deficits in social reciprocity, nonverbal communicative behaviors used for social interaction, and skills in developing, maintaining, and understanding relationships.¹ In addition, the diagnosis of ASD requires the presence of restricted, repetitive patterns of behavior, interests, or activities.

Initially, ASD was considered a rare condition. In recent years, the reported prevalence has increased substantially. The most recent estimated prevalence is 1 in 68 children at age 8, with a male-to-female ratio of 4 to 1.²

Behavioral interventions are considered to be the most effective treatment for the core symptoms of ASD. Pharmacologic interventions are used primarily to treat associated or comorbid symptoms rather than the core symptoms. Aggression, self-injurious behavior, and irritability are common targets of pharmacotherapy in patients with ASD. Studies have provided support for the use of antipsychotic agents to treat irritability and associated aggressive behaviors in patients with autism,³ but because these agents have significant adverse effects—including extrapyramidal side effects, somnolence, and weight gain—their use requires a careful risk/benefit assessment. Stimulants have also been shown to be effective in treating comorbid attention-deficit/hyperactivity symptoms. The use of selective serotonin reuptake inhibitors (SSRIs) to manage repetitive behaviors and anxiety is also common.

Here, we review 7 recent studies of the pharmacologic management of ASD (Table).^4-10 These studies examined the role of SSRIs (sertraline, fluoxetine), an acetylcholinesterase inhibitor (donepezil), atypical antipsychotics (risperidone, aripiprazole, lurasidone), natural supplements (vitamin D, omega-3), a diuretic (bumetanide), and a glutamatergic modulator (riluzole) in the treatment of ASD symptoms.

1. Potter LA, Scholze DA, Biag HMB, et al. A randomized controlled trial of sertraline in young children with autism spectrum disorder. Front Psychiatry. 2019;10:810.

Several studies have shown that SSRIs improve language development in children with Fragile X syndrome, based on the Mullen Scales of Early Learning (MSEL). A previously published trial involving children with Fragile X syndrome and comorbid ASD found that sertraline improved expressive language development. Potter et al⁴ examined the role of sertraline in children with ASD only.

Study Design

• In this randomized, double-blind, placebo-controlled trial, 58 children age 24 to 72 months with ASD received low-dose sertraline or placebo for 6 months.
• Of the 179 participants who were screened for eligibility, 58 were included in the study. Of these 58 participants, 32 received sertraline and 26 received placebo. The numbers of participants who discontinued from the sertraline and placebo arms were 8 and 5, respectively.
• Among those in the sertraline group, participants age <48 months received 2.5 mg/d, and those age ≥48 months received 5 mg/d.

Outcomes

• No significant differences were found on the primary outcome (MSEL expressive language raw score and age-equivalent combined score) or secondary outcomes (including Clinical Global Impressions–Improvement [CGI-I] scale at 3 months and end of treatment), as per intent-to-treat analyses.
• Sertraline was well tolerated. There was no difference in adverse effects between treatment groups and no serious adverse events.

Conclusion

• Although potentially useful for language development in patients with Fragile X syndrome with comorbid ASD, SSRIs such as sertraline have not proven efficacious for improving expressive language in patients with non-syndromic ASD.
• While 6-month treatment with low-dose sertraline in young children with ASD appears safe, the long-term effects are unknown.

Continue to: Gabis et al⁵ examined the safety...

2. Gabis LV, Ben-Hur R, Shefer S, et al. Improvement of language in children with autism with combined donepezil and choline treatment. J Mol Neurosci. 2019;69(2):224-234.

Gabis et al⁵ examined the safety and efficacy of utilizing donepezil, an acetylcholinesterase inhibitor, plus a choline supplement to treat both core features and associated symptoms in children and adolescents with ASD.

Study design

• This 9-month randomized, double-blind trial included 60 children/adolescents with ASD who were randomly assigned to receive placebo or donepezil plus a choline supplement. Participants underwent a baseline evaluation (E1), 12 weeks of treatment and re-evaluation (E2), 6 months of washout, and a final evaluation (E3).
• The baseline and final evaluations assessed changes in language performance, adaptive functioning, sleep habits, autism severity, clinical impression, and intellectual abilities. The evaluation after 12 weeks of treatment (E2) included all of these measures except intellectual abilities.

Outcomes

• Patients treated with donepezil plus a choline supplement had significant improvement in receptive language skills between E1 and E3 (P = .003).
• Patients treated with donepezil plus a choline supplement had significant worsening in scores on the Autism Treatment Evaluation Checklist (ATEC) health/physical behavior subscale between E1 and E2 (P = .012) and between E1 and E3 (P = .021).
• Improvement in receptive language skills was significant only in patients age 5 to 10 years (P = .047), whereas worsening in ATEC health/physical behavior subscale score was significant only in patients age 10 to 16 years (P = .024).
• Patients treated with donepezil plus a choline supplement reported higher percentages of gastrointestinal disturbance when compared with placebo (P = .007), and patients in the adolescent subgroup had a significant increase in irritability (P = .035).

Conclusion

• Patients age 5 to 10 years treated with donepezil plus a choline supplement exhibited improved receptive language skills. This treatment was less effective in patients age >10 years, and this group also exhibited behavioral worsening.
• Gastrointestinal disturbances were the main adverse effect of treatment with donepezil plus a choline supplement.

Continue to: The persistence of excitatory...

3. James BJ, Gales MA, Gales BJ. Bumetanide for autism spectrum disorder in children: a review of randomized controlled trials. Ann Pharmacother. 2019;53(5):537-544.

The persistence of excitatory gamma-aminobutyric acid (GABA) signaling has been found in patients with ASD. Bumetanide is a sodium-potassium-chloride cotransporter 1 (NKCC1) antagonist that not only decreases intracellular chloride, but also aberrantly decreases GABA signaling. This potent loop diuretic is a proposed treatment for symptoms of ASD. James et al⁶ evaluated the safety and efficacy of bumetanide use in children with ASD.
 

Study design

• Researchers searched the PubMed and Ovid MEDLINE databases for the terms “autism” and “bumetanide” between 1946 and 2018. A total of 26 articles were screened by title, 7 were screened by full text, and 3 articles were included in the study. The remaining articles were excluded due to study design and use of non-human subjects.
• All 3 randomized controlled trials evaluated the effects of low-dose oral bumetanide (most common dose was 0.5 mg twice daily) in a total of 208 patients age 2 to 18 years.
• Measurement scales used in the 3 studies included the Childhood Autism Rating Scale (CARS), Clinical Global Impressions Scale (CGI), Autism Behavioral Checklist (ABC), Social Responsiveness Scale (SRS), and Autism Diagnostic Observation Schedule-Generic (ADOS-G).

Outcomes

• Bumetanide improved scores on multiple autism assessment scales, including CARS, but the degree of improvement was not consistent across the 3 trials.
• There was a statistically significant improvement in ASD symptoms as measured by CGI in all 3 trials, and statistically significant improvements on the ABC and SRS in 2 trials. No improvements were noted on the ADOS-G in any of the trials.
• No dose-effect correlation was identified, but hypokalemia and polyuria were more prevalent with higher doses of bumetanide.

Conclusion

• Low-dose oral bumetanide improved social communication, social interactions, and restricted interests in patients with moderate to severe ASD. However, the 3 trials used different evaluation methods and observed varying degrees of improvement, which makes it difficult to make recommendations for or against the use of bumetanide.
• Streamlined trials with a consensus on evaluation methodology are needed to draw conclusions about the efficacy and safety of bumetanide as a treatment for ASD.

Continue to: The use of SSRIs to target...

4. Li C, Bai Y, Jin C, et al. Efficacy and safety of fluoxetine in autism spectrum disorder: a meta-analysis. Am J Ther. 2020;27(3):e312-e315.

The use of SSRIs to target symptoms of ASD has been long studied because many children with ASD have elevated serotonin levels. Several SSRIs, including fluoxetine, are FDA-approved for the treatment of obsessive-compulsive disorder, anxiety, and depression. Currently, no SSRIs are FDA-approved for treating ASD. In a meta-analysis, Li et al⁷ evaluated the use of fluoxetine for ASD.
 

Study design

• Two independent researchers searched for studies of fluoxetine treatment for ASD in Embase, Google Scholar, Ovid SP, and PubMed, with disagreement resolved by consensus.
• The researchers extracted the study design, patient demographics, and outcomes (inter-rater reliability kappa = 0.93). The primary outcomes were response rate of patients treated with fluoxetine, and change from baseline in ABC, ATEC, CARS, CGI, and Yale-Brown Obsessive Compulsive Scale (Y-BOCS) scores after fluoxetine treatment.

Outcomes

• This meta-analysis included 13 studies in which fluoxetine was used to treat a total of 303 patients with ASD. The median treatment duration was 6 months, the average age of participants was 15.23 years, and most participants (72%) were male.
• The response rate of patients treated with fluoxetine was 75%, with significant mean changes from baseline in ABC score (Helvetica Neue LT Std−3.42), ATEC score (Helvetica Neue LT Std−2.04), CGI score (Helvetica Neue LT Std−0.93), and Y-BOCS score (Helvetica Neue LT Std−1.86).
• A significantly higher incidence of hyperactivity/restlessness/agitation was noted with fluoxetine.

Conclusion

• Although 75% of participants re­sponded to fluoxetine, the limitations of this meta-analysis included low power, inadequate quality of the included studies, and high statistical heterogeneity. In addition, the analysis found a high incidence of hyperactivity/restlessness associated with fluoxetine.
• Future randomized controlled studies may provide further clarification on managing symptoms of ASD with SSRIs.

Continue to: Irritability is a common comorbid...

5. Fallah MS, Shaikh MR, Neupane B, et al. Atypical antipsychotics for irritability in pediatric autism: a systematic review and network meta-analysis. J Child Adolesc Psychopharmacol. 2019;29(3):168-180.

Irritability is a common comorbid symptom in children with ASD. Two second-generation antipsychotics (SGAs)—risperidone and aripiprazole—are FDA-approved for irritability associated with ASD. Fallah et al⁸ examined the efficacy of several SGAs for treating irritability.

Study design

• This review and meta-analysis included 8 studies identified from Medline, PsycINFO, and Embase from inception to March 2018. It included double-blind, randomized controlled trials that used the Aberrant Behavior Checklist Irritability (ABC-I) to measure irritability.
• The main outcome was change in degree of irritability.
• The 8 studies compared the efficacy of risperidone, aripiprazole, lurasidone, and placebo in a total of 878 patients.

Outcomes

• Risperidone reduced ABC-I scores more than aripiprazole, lurasidone, or placebo.
• Mean differences in ABC-I scores were Helvetica Neue LT Std−6.89 for risperidone, Helvetica Neue LT Std−6.62 for aripiprazole, and Helvetica Neue LT Std−1.61 for lurasidone.

Conclusion

• Risperidone and aripiprazole were efficacious and safe for children with ASD-associated irritability.
• Lurasidone may minimally improve irritability in children with ASD.

Continue to: Irritability and hyperactivity are common...

6. Mazahery H, Conlon CA, Beck KL, et al. A randomised controlled trial of vitamin D and omega-3 long chain polyunsaturated fatty acids in the treatment of irritability and hyperactivity among children with autism spectrum disorder. J Steroid Biochem Mol Biol. 2019;187:9-16.

Irritability and hyperactivity are common comorbid symptoms in children with ASD and have been linked to lower quality of life, poor adaptive functioning, and lower responsiveness to treatments when compared to children without comorbid problem behaviors. Mazahery et al⁹ evaluated the efficacy of vitamin D, omega-3 long-chain polyunsaturated fatty acids (LCPUFA), or both on irritability and hyperactivity.

Study design

• In a 1-year, double-blind, placebo-controlled trial, 73 children age 2.5 to 8 years with ASD were randomly assigned to receive placebo; vitamin D, 2000 IU/d (VID); omega-3 LCPUFA, 722 mg/d (OM); or both in the aforementioned doses.
• The primary outcome was reduction in the Aberrant Behavior Checklist in the domains of irritability and hyperactivity. Caregivers also completed weekly surveys regarding adverse events, compliance, and utilization of behavioral therapies.
• Of 111 children enrolled, 73 completed the 12 months of treatment.

Outcomes

• Children who received OM and VID had a greater reduction in irritability than those who received placebo (P = .001 and P = .01, respectively).
• Children who received VID also had a reduction in irritability (P = .047).
• An explanatory analysis revealed that OM also reduced lethargy (based on the Aberrant Behavior Checklist) more significantly than placebo (P = .02 adjusted for covariates).

Conclusion

• Treatment with vitamin D, 2000 IU/d, reduced irritability and hyperactivity.
• Treatment with omega-3 LCPUFA, 722 mg/d, reduced hyperactivity and lethargy.

Continue to: Glutamatergic dysregulation has been...

7. Wink LK, Adams R, Horn PS, et al. A randomized placebo-controlled cross-over pilot study of riluzole for drug-refractory irritability in autism spectrum disorder. J Autism Dev Disord. 2018;48(9):3051-3060.

Glutamatergic dysregulation has been identified as a potential cause of ASD. Riluzole, a glutamatergic modulator that is FDA-approved for treating amyotrophic lateral sclerosis, is a drug of interest for the treatment of ASD-related irritability due to this proposed mechanism. Wink et al¹⁰ evaluated riluzole for irritability in patients with ASD.

Study design

• This randomized, double-blind, placebo-controlled, crossover pilot study evaluated the tolerability and safety of adjunctive riluzole treatment for drug-refractory irritability in 8 patients with ASD.
• Participants were age 12 to 25 years, had a diagnosis of ASD confirmed by the autism diagnostic observation schedule 2, and an ABC-I subscale score ≥18. Participants receiving ≥2 psychotropic medications or glutamatergic/GABA-modulating medications were excluded.
• Participants received either 5 weeks of riluzole followed by 5 weeks of placebo, or vice versa; both groups then had a 2-week washout period.
• Riluzole was started at 50 mg/d, and then increased in 50 mg/d–increments to a maximum of 200 mg/d by Week 4.
• Primary outcome measures were change in score on the ABC-I and CGI-I.

Outcomes

• No significant treatment effects were identified.
• All participants tolerated riluzole, 200 mg/d, but increased dosages did not result in a higher overall treatment effect.
• There were no clinically significant adverse effects or laboratory abnormalities.

Conclusion

• Riluzole, 200 mg/d, was well tolerated but had no significant effect on irritability in adolescents with ASD.

Autism spectrum disorder (ASD) is characterized by persistent deficits in social communication and social interaction, including deficits in social reciprocity, nonverbal communicative behaviors used for social interaction, and skills in developing, maintaining, and understanding relationships.¹ In addition, the diagnosis of ASD requires the presence of restricted, repetitive patterns of behavior, interests, or activities.

Initially, ASD was considered a rare condition. In recent years, the reported prevalence has increased substantially. The most recent estimated prevalence is 1 in 68 children at age 8, with a male-to-female ratio of 4 to 1.²

Behavioral interventions are considered to be the most effective treatment for the core symptoms of ASD. Pharmacologic interventions are used primarily to treat associated or comorbid symptoms rather than the core symptoms. Aggression, self-injurious behavior, and irritability are common targets of pharmacotherapy in patients with ASD. Studies have provided support for the use of antipsychotic agents to treat irritability and associated aggressive behaviors in patients with autism,³ but because these agents have significant adverse effects—including extrapyramidal side effects, somnolence, and weight gain—their use requires a careful risk/benefit assessment. Stimulants have also been shown to be effective in treating comorbid attention-deficit/hyperactivity symptoms. The use of selective serotonin reuptake inhibitors (SSRIs) to manage repetitive behaviors and anxiety is also common.

Here, we review 7 recent studies of the pharmacologic management of ASD (Table).^4-10 These studies examined the role of SSRIs (sertraline, fluoxetine), an acetylcholinesterase inhibitor (donepezil), atypical antipsychotics (risperidone, aripiprazole, lurasidone), natural supplements (vitamin D, omega-3), a diuretic (bumetanide), and a glutamatergic modulator (riluzole) in the treatment of ASD symptoms.

1. Potter LA, Scholze DA, Biag HMB, et al. A randomized controlled trial of sertraline in young children with autism spectrum disorder. Front Psychiatry. 2019;10:810.

Several studies have shown that SSRIs improve language development in children with Fragile X syndrome, based on the Mullen Scales of Early Learning (MSEL). A previously published trial involving children with Fragile X syndrome and comorbid ASD found that sertraline improved expressive language development. Potter et al⁴ examined the role of sertraline in children with ASD only.

Study Design

• In this randomized, double-blind, placebo-controlled trial, 58 children age 24 to 72 months with ASD received low-dose sertraline or placebo for 6 months.
• Of the 179 participants who were screened for eligibility, 58 were included in the study. Of these 58 participants, 32 received sertraline and 26 received placebo. The numbers of participants who discontinued from the sertraline and placebo arms were 8 and 5, respectively.
• Among those in the sertraline group, participants age <48 months received 2.5 mg/d, and those age ≥48 months received 5 mg/d.

Outcomes

• No significant differences were found on the primary outcome (MSEL expressive language raw score and age-equivalent combined score) or secondary outcomes (including Clinical Global Impressions–Improvement [CGI-I] scale at 3 months and end of treatment), as per intent-to-treat analyses.
• Sertraline was well tolerated. There was no difference in adverse effects between treatment groups and no serious adverse events.

Conclusion

• Although potentially useful for language development in patients with Fragile X syndrome with comorbid ASD, SSRIs such as sertraline have not proven efficacious for improving expressive language in patients with non-syndromic ASD.
• While 6-month treatment with low-dose sertraline in young children with ASD appears safe, the long-term effects are unknown.

Continue to: Gabis et al⁵ examined the safety...

2. Gabis LV, Ben-Hur R, Shefer S, et al. Improvement of language in children with autism with combined donepezil and choline treatment. J Mol Neurosci. 2019;69(2):224-234.

Gabis et al⁵ examined the safety and efficacy of utilizing donepezil, an acetylcholinesterase inhibitor, plus a choline supplement to treat both core features and associated symptoms in children and adolescents with ASD.

Study design

• This 9-month randomized, double-blind trial included 60 children/adolescents with ASD who were randomly assigned to receive placebo or donepezil plus a choline supplement. Participants underwent a baseline evaluation (E1), 12 weeks of treatment and re-evaluation (E2), 6 months of washout, and a final evaluation (E3).
• The baseline and final evaluations assessed changes in language performance, adaptive functioning, sleep habits, autism severity, clinical impression, and intellectual abilities. The evaluation after 12 weeks of treatment (E2) included all of these measures except intellectual abilities.

Outcomes

• Patients treated with donepezil plus a choline supplement had significant improvement in receptive language skills between E1 and E3 (P = .003).
• Patients treated with donepezil plus a choline supplement had significant worsening in scores on the Autism Treatment Evaluation Checklist (ATEC) health/physical behavior subscale between E1 and E2 (P = .012) and between E1 and E3 (P = .021).
• Improvement in receptive language skills was significant only in patients age 5 to 10 years (P = .047), whereas worsening in ATEC health/physical behavior subscale score was significant only in patients age 10 to 16 years (P = .024).
• Patients treated with donepezil plus a choline supplement reported higher percentages of gastrointestinal disturbance when compared with placebo (P = .007), and patients in the adolescent subgroup had a significant increase in irritability (P = .035).

Conclusion

• Patients age 5 to 10 years treated with donepezil plus a choline supplement exhibited improved receptive language skills. This treatment was less effective in patients age >10 years, and this group also exhibited behavioral worsening.
• Gastrointestinal disturbances were the main adverse effect of treatment with donepezil plus a choline supplement.

Continue to: The persistence of excitatory...

3. James BJ, Gales MA, Gales BJ. Bumetanide for autism spectrum disorder in children: a review of randomized controlled trials. Ann Pharmacother. 2019;53(5):537-544.

The persistence of excitatory gamma-aminobutyric acid (GABA) signaling has been found in patients with ASD. Bumetanide is a sodium-potassium-chloride cotransporter 1 (NKCC1) antagonist that not only decreases intracellular chloride, but also aberrantly decreases GABA signaling. This potent loop diuretic is a proposed treatment for symptoms of ASD. James et al⁶ evaluated the safety and efficacy of bumetanide use in children with ASD.
 

Study design

• Researchers searched the PubMed and Ovid MEDLINE databases for the terms “autism” and “bumetanide” between 1946 and 2018. A total of 26 articles were screened by title, 7 were screened by full text, and 3 articles were included in the study. The remaining articles were excluded due to study design and use of non-human subjects.
• All 3 randomized controlled trials evaluated the effects of low-dose oral bumetanide (most common dose was 0.5 mg twice daily) in a total of 208 patients age 2 to 18 years.
• Measurement scales used in the 3 studies included the Childhood Autism Rating Scale (CARS), Clinical Global Impressions Scale (CGI), Autism Behavioral Checklist (ABC), Social Responsiveness Scale (SRS), and Autism Diagnostic Observation Schedule-Generic (ADOS-G).

Outcomes

• Bumetanide improved scores on multiple autism assessment scales, including CARS, but the degree of improvement was not consistent across the 3 trials.
• There was a statistically significant improvement in ASD symptoms as measured by CGI in all 3 trials, and statistically significant improvements on the ABC and SRS in 2 trials. No improvements were noted on the ADOS-G in any of the trials.
• No dose-effect correlation was identified, but hypokalemia and polyuria were more prevalent with higher doses of bumetanide.

Conclusion

• Low-dose oral bumetanide improved social communication, social interactions, and restricted interests in patients with moderate to severe ASD. However, the 3 trials used different evaluation methods and observed varying degrees of improvement, which makes it difficult to make recommendations for or against the use of bumetanide.
• Streamlined trials with a consensus on evaluation methodology are needed to draw conclusions about the efficacy and safety of bumetanide as a treatment for ASD.

Continue to: The use of SSRIs to target...

4. Li C, Bai Y, Jin C, et al. Efficacy and safety of fluoxetine in autism spectrum disorder: a meta-analysis. Am J Ther. 2020;27(3):e312-e315.

The use of SSRIs to target symptoms of ASD has been long studied because many children with ASD have elevated serotonin levels. Several SSRIs, including fluoxetine, are FDA-approved for the treatment of obsessive-compulsive disorder, anxiety, and depression. Currently, no SSRIs are FDA-approved for treating ASD. In a meta-analysis, Li et al⁷ evaluated the use of fluoxetine for ASD.
 

Study design

• Two independent researchers searched for studies of fluoxetine treatment for ASD in Embase, Google Scholar, Ovid SP, and PubMed, with disagreement resolved by consensus.
• The researchers extracted the study design, patient demographics, and outcomes (inter-rater reliability kappa = 0.93). The primary outcomes were response rate of patients treated with fluoxetine, and change from baseline in ABC, ATEC, CARS, CGI, and Yale-Brown Obsessive Compulsive Scale (Y-BOCS) scores after fluoxetine treatment.

Outcomes

• This meta-analysis included 13 studies in which fluoxetine was used to treat a total of 303 patients with ASD. The median treatment duration was 6 months, the average age of participants was 15.23 years, and most participants (72%) were male.
• The response rate of patients treated with fluoxetine was 75%, with significant mean changes from baseline in ABC score (Helvetica Neue LT Std−3.42), ATEC score (Helvetica Neue LT Std−2.04), CGI score (Helvetica Neue LT Std−0.93), and Y-BOCS score (Helvetica Neue LT Std−1.86).
• A significantly higher incidence of hyperactivity/restlessness/agitation was noted with fluoxetine.

Conclusion

• Although 75% of participants re­sponded to fluoxetine, the limitations of this meta-analysis included low power, inadequate quality of the included studies, and high statistical heterogeneity. In addition, the analysis found a high incidence of hyperactivity/restlessness associated with fluoxetine.
• Future randomized controlled studies may provide further clarification on managing symptoms of ASD with SSRIs.

Continue to: Irritability is a common comorbid...

5. Fallah MS, Shaikh MR, Neupane B, et al. Atypical antipsychotics for irritability in pediatric autism: a systematic review and network meta-analysis. J Child Adolesc Psychopharmacol. 2019;29(3):168-180.

Irritability is a common comorbid symptom in children with ASD. Two second-generation antipsychotics (SGAs)—risperidone and aripiprazole—are FDA-approved for irritability associated with ASD. Fallah et al⁸ examined the efficacy of several SGAs for treating irritability.

Study design

• This review and meta-analysis included 8 studies identified from Medline, PsycINFO, and Embase from inception to March 2018. It included double-blind, randomized controlled trials that used the Aberrant Behavior Checklist Irritability (ABC-I) to measure irritability.
• The main outcome was change in degree of irritability.
• The 8 studies compared the efficacy of risperidone, aripiprazole, lurasidone, and placebo in a total of 878 patients.

Outcomes

• Risperidone reduced ABC-I scores more than aripiprazole, lurasidone, or placebo.
• Mean differences in ABC-I scores were Helvetica Neue LT Std−6.89 for risperidone, Helvetica Neue LT Std−6.62 for aripiprazole, and Helvetica Neue LT Std−1.61 for lurasidone.

Conclusion

• Risperidone and aripiprazole were efficacious and safe for children with ASD-associated irritability.
• Lurasidone may minimally improve irritability in children with ASD.

Continue to: Irritability and hyperactivity are common...

6. Mazahery H, Conlon CA, Beck KL, et al. A randomised controlled trial of vitamin D and omega-3 long chain polyunsaturated fatty acids in the treatment of irritability and hyperactivity among children with autism spectrum disorder. J Steroid Biochem Mol Biol. 2019;187:9-16.

Irritability and hyperactivity are common comorbid symptoms in children with ASD and have been linked to lower quality of life, poor adaptive functioning, and lower responsiveness to treatments when compared to children without comorbid problem behaviors. Mazahery et al⁹ evaluated the efficacy of vitamin D, omega-3 long-chain polyunsaturated fatty acids (LCPUFA), or both on irritability and hyperactivity.

Study design

• In a 1-year, double-blind, placebo-controlled trial, 73 children age 2.5 to 8 years with ASD were randomly assigned to receive placebo; vitamin D, 2000 IU/d (VID); omega-3 LCPUFA, 722 mg/d (OM); or both in the aforementioned doses.
• The primary outcome was reduction in the Aberrant Behavior Checklist in the domains of irritability and hyperactivity. Caregivers also completed weekly surveys regarding adverse events, compliance, and utilization of behavioral therapies.
• Of 111 children enrolled, 73 completed the 12 months of treatment.

Outcomes

• Children who received OM and VID had a greater reduction in irritability than those who received placebo (P = .001 and P = .01, respectively).
• Children who received VID also had a reduction in irritability (P = .047).
• An explanatory analysis revealed that OM also reduced lethargy (based on the Aberrant Behavior Checklist) more significantly than placebo (P = .02 adjusted for covariates).

Conclusion

• Treatment with vitamin D, 2000 IU/d, reduced irritability and hyperactivity.
• Treatment with omega-3 LCPUFA, 722 mg/d, reduced hyperactivity and lethargy.

Continue to: Glutamatergic dysregulation has been...

7. Wink LK, Adams R, Horn PS, et al. A randomized placebo-controlled cross-over pilot study of riluzole for drug-refractory irritability in autism spectrum disorder. J Autism Dev Disord. 2018;48(9):3051-3060.

Glutamatergic dysregulation has been identified as a potential cause of ASD. Riluzole, a glutamatergic modulator that is FDA-approved for treating amyotrophic lateral sclerosis, is a drug of interest for the treatment of ASD-related irritability due to this proposed mechanism. Wink et al¹⁰ evaluated riluzole for irritability in patients with ASD.

Study design

• This randomized, double-blind, placebo-controlled, crossover pilot study evaluated the tolerability and safety of adjunctive riluzole treatment for drug-refractory irritability in 8 patients with ASD.
• Participants were age 12 to 25 years, had a diagnosis of ASD confirmed by the autism diagnostic observation schedule 2, and an ABC-I subscale score ≥18. Participants receiving ≥2 psychotropic medications or glutamatergic/GABA-modulating medications were excluded.
• Participants received either 5 weeks of riluzole followed by 5 weeks of placebo, or vice versa; both groups then had a 2-week washout period.
• Riluzole was started at 50 mg/d, and then increased in 50 mg/d–increments to a maximum of 200 mg/d by Week 4.
• Primary outcome measures were change in score on the ABC-I and CGI-I.

Outcomes

• No significant treatment effects were identified.
• All participants tolerated riluzole, 200 mg/d, but increased dosages did not result in a higher overall treatment effect.
• There were no clinically significant adverse effects or laboratory abnormalities.

Conclusion

• Riluzole, 200 mg/d, was well tolerated but had no significant effect on irritability in adolescents with ASD.

COVID-19 and decision-making capacity

Dr. Ryznar’s article “Evaluating patients’ decision-making capacity during COVID-19” (Evidence-Based Reviews, Current Psychiatry. October 2020, p. 34-40) provides a cogent overview of the “threshold” or “gradient” approach to capacity evaluations, wherein the assessment of a patient’s decisional capacity hinges on the risks and benefits of the specific clinical intervention. From a medico­legal perspective, however, I am concerned that Dr. Ryznar makes a consequential category error in framing sociopolitically-driven noncompliance with infectious disease control measures as a capacity problem. In the United States, public health powers—including the use of isolation and quarantine—fall to properly constituted public health authorities, predominantly at the state and local levels. An infectious patient with suspect ideas about coronavirus disease 2019 (COVID-19) whose decision-making process is not directly compromised by neurocognitive illness does not present a capacity issue, but rather a potential public health issue.

For example, in a controversial 2007 case in Atlanta, Georgia, an attorney with active tuberculosis failed to heed medical advice to refrain from traveling.¹ The patient’s uncooperativeness did not implicate concerns over his decisional capacity.¹ However, his international and interstate travel triggered the Centers for Disease Control and Prevention’s legal authority under the Public Health Service Act to prevent the entry and spread of communicable disease.^1-3 An authorized order from a duly constituted public health authority is issued and enforceable without regard to clinical determinations of capacity (and is generally subject to challenge via judicial or other due process mechanisms as a government-sanctioned deprivation of liberty to protect public welfare). State laws and local ordinances require physicians to notify the appropriate public health department when patients test positive for certain contagious diseases.

The difficulty with involuntarily detaining a cognitively intact patient due to concern over their contagion risk and erroneous beliefs runs considerably deeper than eliciting a “political backlash” or managing the qualms of hospital security officers. It is a fundamental matter of proper legal authority. Psychiatrists and other physicians assess patients’ decision-making capacity for specific treatment decisions on a case-by-case basis, seeking to preserve autonomy while practicing beneficence. Public health officers are agents of the state with designated authorities to control the spread of disease. A capacity determination in the absence of neurocognitive deficits implies the psychiatrist is evaluating the soundness of the patient’s ideas as opposed to their cognition, overlooking the reality that fully capable individuals can possess dubious—and even unsalutary—beliefs. While physicians educate patients about the risks of contracting and communicating infection, they are thankfully not tasked with arbitrating sociopolitical disputes at the bedside. Such controversies regarding pandemic response do not belong under the rubric of medical decision-making capacity. Conflating psychosomatic medicine consultations with public health orders risks unmooring capacity determinations from their medicolegal and bioethical foundations.

Charles G. Kels, JD
S Army Medical Center of Excellence
San Antonio, Texas  

Disclaimer: The views expressed here are those of the author and do not necessarily reflect those of any government agency.

References

1. Tanne JH. Tuberculosis case exposes flaws in international public health systems. BMJ. 2007;334(7605):1187.
2. Public Health Service Act, 42 USC § 264-272 (1944).
3. Interstate and Foreign Quarantine, 42 CFR Parts 70-71 (2017).

The author responds

I appreciate Mr. Kels’s letter and explicit discussion of the limits of decision-making capacity. I agree that physicians should not overstep their legal authority and ethical mandate. The specific case discussed in my article was a patient who was symptomatic from COVID-19 who wanted to leave the hospital against medical advice. The contagious nature of this virus certainly falls under the risk/benefit analysis of the clinical situation because it is an important aspect of understanding the nature of the illness and treatment/recovery process (as a thought example, consider that such a patient lives with their elderly mother who has heart disease and chronic obstructive pulmonary disease, and the patient does not want their mother to die). From a medico­legal perspective, the risk of infection to others may not necessarily outweigh the benefit of autonomy, especially because decision-making capacity assessments are made with the purpose of balancing autonomy and beneficence of the patient, not others. I highlighted the relative importance of autonomy using the weight of the arrows in Figure 2 of my article. I did not task physicians with arbitrating sociopolitical disputes, but merely highlighted how the current climate can impact people’s personal views on COVID-19, which sometimes can run counter to scientific evidence. If a patient has an erroneous view about an illness, it is our duty to try to help them understand if it directly impacts their health or affects their decision-making process, especially in a high-stakes clinical scenario.

Elizabeth Ryznar, MD, MSc
Assistant Professor
Department of Psychiatry and Behavioral Sciences
Johns Hopkins School of Medicine
Baltimore, Maryland

Continue to: Olanzapine for treatment-resistant anxiety

Olanzapine for treatment-resistant anxiety

Ms. A, age 62, was a retired high school teacher. Her primary care physician referred her to me for persistent, disabling anxiety. Her condition was recently worsened by a trial of escitalopram, 5 mg/d, which led her to visit the emergency department (ED). There she was prescribed lorazepam, 0.5 mg as needed, which helped her somewhat. Her medical conditions included prominent gastrointestinal (GI) symptoms, with nausea and a restricted diet; tinnitus; and chronic bilateral hand tremors. Her initial Patient Health Questionnaire-9 (PHQ-9) score was 11, and her Generalized Anxiety Disorder-7 (GAD-7) score was 10.

Initially, I encouraged Ms. A to exercise regularly, and I changed her lorazepam from 0.5 mg as-needed to 0.5 mg twice a day. I also referred her to a psychologist for psychotherapy. She showed limited improvement. I increased her lorazepam to 1 mg 3 times a day and started sertraline, 12.5 mg/d, but she soon experienced chest tightness and was admitted to the ED for observation and a cardiac workup. After she visited the ED, Ms. A stopped taking sertraline.

When I next saw Ms. A, she agreed to a trial of olanzapine, 2.5 mg/d at bedtime. Three weeks later, she told me, “I feel so much better.” Her scores on the PHQ-9 and GAD-7 were 0 and 1, respectively. Her GI complaints decreased, she had gained a little weight, and her tinnitus bothered her less. Lorazepam was gradually decreased and stopped.

After approximately 2 years, Ms. A had experienced no long-term adverse effects. We agreed to gradually discontinue olanzapine. Over the next 4 months, Ms. A decreased and stopped taking olanzapine at her own discretion.Three weeks after she stopped taking olanzapine, Ms. A reported that her psychiatric and GI symptoms had returned. She still maintained weekly visits with her psychotherapist. Her GI specialist asked if I could prescribe her olanzapine again. I restarted Ms. A on olanzapine, 2.5 mg/d at bedtime. By the next month, she said she felt much better (PHQ-9: 0; GAD-7: 1). I last saw Ms. A approximately 1 year ago.

Over the years, I have usually prescribed low-dose olanzapine alone or with other medications for patients with treatment-resistance who had no overt psychotic symptoms, I have used this medication for patients with “soft” psychotic thinking marked by severe anxiety, obsessions, compulsivity, perfectionism, and/or rumination.¹ Evidence suggests olanzapine also may be effective for anorexia nervosa.² There is good evidence for its use in the DSM-5 diagnosis of avoidant/restrictive food intake disorder (“a food avoidance emotional disorder”).^3,4 In retrospect, Ms. A also likely met the criteria for the diagnosis of unspecified eating disorder. Despite extensive GI workup and follow-up, physical signs of GI pathology were equivocal.

Among antipsychotics, olanzapine most closely resembles clozapine, the only antipsychotic that has been proved more efficacious than others for psychotic symptoms.⁵ There is also some research suggesting that olanzapine may be more efficacious.⁶ Obsessions and perfectionism are associated with dopamine D4 receptor activity, and D1, D2, and D3 receptors are involved in normalizing cognition and reward.⁷ There are appropriate concerns about adverse effects, especially metabolic syndrome and obesity, with olanzapine, but patients can have different profiles of receptor sensitivity. In my conversations with Ms. A’s primary care physician and GI specialist, metabolic syndrome was not an issue. Clearly, low-dose olanzapine was very helpful in her treatment.

Daniel Storch, MD
Key Point Health Services
Catonsville, Maryland

References

1. Goodnick PJ, Barrios CA. Use of olanzapine in non-psychotic psychiatric disorders. Expert Opin Pharmacother. 2001;2(4):667-680.
2. Brewerton TD. Psychopharmacologic management of eating disorders. Presented at: 25th Annual National Psychopharmacology Update; February 2020; Las Vegas, Nevada. Accessed December 8, 2020. https://legacy.audio-digest.org/pages/htmlos/pastissues.html?sub1=psychiatry&sub2=2020
3. Diagnostic and statistical manual of mental disorders, 5th ed. American Psychiatric Association; 2013.
4. Brewerton TD, D’Agostino M. Adjunctive use of olanzapine in the treatment of avoidant restrictive food intake disorder in children and adolescents in an eating disorders program. J Child Adolesc Psychopharmacol. 2017;27(10):920-922.
5. Lobos CA, Komossa K, Rummel-Kluge C, et al. Clozapine versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2010;(11):CD006633.
6. Komossa K, Rummel-Kluge C, Hunger H, et al. Olanzapine versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2010;(3):CD006654.
7. Bachner-Melman R, Lerer E, Zohar AH, et al. Anorexia nervosa, perfectionism, and dopamine D4 receptor (DRD4). Am J Med Genet B Neuropsychiatr Genet. 2007;144B(6):748-756.

Continue to: Neuro-politics and academic paralysis...

Neuro-politics and academic paralysis

I commend Dr. Nasrallah for his brief, precisely defined, scientific editorial “Neuro-politics: Will you vote with your cortex or limbic system?” (From the Editor, Current Psychiatry. October 2020, p. 14-15,63). Furthermore, he has demonstrated an admirable intellectual juggling ability to discuss politics while staying off it. This is no easy task when we witness stress, fear, and loathing from the media in the streets and academic institutes.

I would like to see Current Psychiatry and the academic psychiatric community dig deeper into what I will term as the emerging academic paralysis. Psychiatric forums and publications have been sheepish about addressing, probing, and analyzing the bitter divisions in the United States and in other nations. It appears apropos to Dr. Nasrallah’s editorial that the limbic system has trumped the prefrontal cortex. As in adolescence, this process has risks, because brain regions governing reward, impulsivity, and sensation-seeking have become—due to the choice of the “Bon Ton” political-correctness church—more influential than higher-order cognitive regions regulating behavioral inhibition, decision-making, and planning,

Similar to a hurricane or tsunami that pushes water into a river, this retro­grade shift of feedback pathways is demonstrated by emotional narratives that have flooded the public and drowned facts and evidence-based practice. Furthermore, the science of convenience has emerged, where facts are eligible only if they justify the narrative. Any discussion, debate, or questioning of the rationale of the approach is met with hostility, naming, shaming, and even loss of employment at universities. I have sadly learned from frightened colleagues and from reading reports by academicians whose publications have been either rejected or coerced for revision following acceptance by a peer-reviewed journal or even retracted post-publication due to complaints, harassment, and threats by the politically correct “thought police.” Diversity of thinking and freedom of speech—core values and principles in academic dialogue—have been violated. Academicians are as perplexed as laboratory rats that need to learn which lever to push in order to receive a reward and avoid punishment in an ever-shifting environment. People have been pondering, “Is it time for flight, fright, or fight?” As Buffalo Springfield’s legendary Vietnam 1960s–era song “For What it’s Worth” states: “There’s battle lines being drawn and nobody’s right if everybody’s wrong.”

What we have learned from history is that the majority of people exercise passivity and hope as bystanders in order to avoid becoming victims of “collateral damage.” Are there no modern Giordano Bruno (the martyr of science), Copernicus, or Michelangelo who would challenge the “Church of the People” that has created new language, terminology, and culture and is on the verge of creating nouveau scientific principles that could lead to a monopoly of one segment of society that threatens pluralism of thought. Do we need dystopic books such as 1984 or Fahrenheit 451, or the experience of the French and Russian revolution (epitomized by the guillotine and the gulag) to remind us that we are a step away from education and reprogramming camps that used to be called universities? The American Association of University Professors’ most recent announcement on academic freedom ominously avoids using terms such as freedom of speech, diversity of opinions, or even pluralism.

I hope that psychiatrists will lead the way back to sanity, starting with focus groups and forums. It would amount to a group cognitive-behavioral therapy of immense proportion following a paradigm of “Problem Solving,” according to Albert Bandura’s social learning model. There is simply no other constructive way to get to the cheese at the end of the maze.

Yifrah Kaminer, MD

Professor Emeritus of Psychiatry & Pediatrics
University of Connecticut School of Medicine
Farmington, Connecticut

Disclosures: The authors report no financial relationships with any companies whose products are mentioned in this article, or with manufacturers of competing products.

COVID-19 and decision-making capacity

Dr. Ryznar’s article “Evaluating patients’ decision-making capacity during COVID-19” (Evidence-Based Reviews, Current Psychiatry. October 2020, p. 34-40) provides a cogent overview of the “threshold” or “gradient” approach to capacity evaluations, wherein the assessment of a patient’s decisional capacity hinges on the risks and benefits of the specific clinical intervention. From a medico­legal perspective, however, I am concerned that Dr. Ryznar makes a consequential category error in framing sociopolitically-driven noncompliance with infectious disease control measures as a capacity problem. In the United States, public health powers—including the use of isolation and quarantine—fall to properly constituted public health authorities, predominantly at the state and local levels. An infectious patient with suspect ideas about coronavirus disease 2019 (COVID-19) whose decision-making process is not directly compromised by neurocognitive illness does not present a capacity issue, but rather a potential public health issue.

For example, in a controversial 2007 case in Atlanta, Georgia, an attorney with active tuberculosis failed to heed medical advice to refrain from traveling.¹ The patient’s uncooperativeness did not implicate concerns over his decisional capacity.¹ However, his international and interstate travel triggered the Centers for Disease Control and Prevention’s legal authority under the Public Health Service Act to prevent the entry and spread of communicable disease.^1-3 An authorized order from a duly constituted public health authority is issued and enforceable without regard to clinical determinations of capacity (and is generally subject to challenge via judicial or other due process mechanisms as a government-sanctioned deprivation of liberty to protect public welfare). State laws and local ordinances require physicians to notify the appropriate public health department when patients test positive for certain contagious diseases.

The difficulty with involuntarily detaining a cognitively intact patient due to concern over their contagion risk and erroneous beliefs runs considerably deeper than eliciting a “political backlash” or managing the qualms of hospital security officers. It is a fundamental matter of proper legal authority. Psychiatrists and other physicians assess patients’ decision-making capacity for specific treatment decisions on a case-by-case basis, seeking to preserve autonomy while practicing beneficence. Public health officers are agents of the state with designated authorities to control the spread of disease. A capacity determination in the absence of neurocognitive deficits implies the psychiatrist is evaluating the soundness of the patient’s ideas as opposed to their cognition, overlooking the reality that fully capable individuals can possess dubious—and even unsalutary—beliefs. While physicians educate patients about the risks of contracting and communicating infection, they are thankfully not tasked with arbitrating sociopolitical disputes at the bedside. Such controversies regarding pandemic response do not belong under the rubric of medical decision-making capacity. Conflating psychosomatic medicine consultations with public health orders risks unmooring capacity determinations from their medicolegal and bioethical foundations.

Charles G. Kels, JD
S Army Medical Center of Excellence
San Antonio, Texas  

Disclaimer: The views expressed here are those of the author and do not necessarily reflect those of any government agency.

References

1. Tanne JH. Tuberculosis case exposes flaws in international public health systems. BMJ. 2007;334(7605):1187.
2. Public Health Service Act, 42 USC § 264-272 (1944).
3. Interstate and Foreign Quarantine, 42 CFR Parts 70-71 (2017).

The author responds

I appreciate Mr. Kels’s letter and explicit discussion of the limits of decision-making capacity. I agree that physicians should not overstep their legal authority and ethical mandate. The specific case discussed in my article was a patient who was symptomatic from COVID-19 who wanted to leave the hospital against medical advice. The contagious nature of this virus certainly falls under the risk/benefit analysis of the clinical situation because it is an important aspect of understanding the nature of the illness and treatment/recovery process (as a thought example, consider that such a patient lives with their elderly mother who has heart disease and chronic obstructive pulmonary disease, and the patient does not want their mother to die). From a medico­legal perspective, the risk of infection to others may not necessarily outweigh the benefit of autonomy, especially because decision-making capacity assessments are made with the purpose of balancing autonomy and beneficence of the patient, not others. I highlighted the relative importance of autonomy using the weight of the arrows in Figure 2 of my article. I did not task physicians with arbitrating sociopolitical disputes, but merely highlighted how the current climate can impact people’s personal views on COVID-19, which sometimes can run counter to scientific evidence. If a patient has an erroneous view about an illness, it is our duty to try to help them understand if it directly impacts their health or affects their decision-making process, especially in a high-stakes clinical scenario.

Elizabeth Ryznar, MD, MSc
Assistant Professor
Department of Psychiatry and Behavioral Sciences
Johns Hopkins School of Medicine
Baltimore, Maryland

Continue to: Olanzapine for treatment-resistant anxiety

Olanzapine for treatment-resistant anxiety

Ms. A, age 62, was a retired high school teacher. Her primary care physician referred her to me for persistent, disabling anxiety. Her condition was recently worsened by a trial of escitalopram, 5 mg/d, which led her to visit the emergency department (ED). There she was prescribed lorazepam, 0.5 mg as needed, which helped her somewhat. Her medical conditions included prominent gastrointestinal (GI) symptoms, with nausea and a restricted diet; tinnitus; and chronic bilateral hand tremors. Her initial Patient Health Questionnaire-9 (PHQ-9) score was 11, and her Generalized Anxiety Disorder-7 (GAD-7) score was 10.

Initially, I encouraged Ms. A to exercise regularly, and I changed her lorazepam from 0.5 mg as-needed to 0.5 mg twice a day. I also referred her to a psychologist for psychotherapy. She showed limited improvement. I increased her lorazepam to 1 mg 3 times a day and started sertraline, 12.5 mg/d, but she soon experienced chest tightness and was admitted to the ED for observation and a cardiac workup. After she visited the ED, Ms. A stopped taking sertraline.

When I next saw Ms. A, she agreed to a trial of olanzapine, 2.5 mg/d at bedtime. Three weeks later, she told me, “I feel so much better.” Her scores on the PHQ-9 and GAD-7 were 0 and 1, respectively. Her GI complaints decreased, she had gained a little weight, and her tinnitus bothered her less. Lorazepam was gradually decreased and stopped.

After approximately 2 years, Ms. A had experienced no long-term adverse effects. We agreed to gradually discontinue olanzapine. Over the next 4 months, Ms. A decreased and stopped taking olanzapine at her own discretion.Three weeks after she stopped taking olanzapine, Ms. A reported that her psychiatric and GI symptoms had returned. She still maintained weekly visits with her psychotherapist. Her GI specialist asked if I could prescribe her olanzapine again. I restarted Ms. A on olanzapine, 2.5 mg/d at bedtime. By the next month, she said she felt much better (PHQ-9: 0; GAD-7: 1). I last saw Ms. A approximately 1 year ago.

Over the years, I have usually prescribed low-dose olanzapine alone or with other medications for patients with treatment-resistance who had no overt psychotic symptoms, I have used this medication for patients with “soft” psychotic thinking marked by severe anxiety, obsessions, compulsivity, perfectionism, and/or rumination.¹ Evidence suggests olanzapine also may be effective for anorexia nervosa.² There is good evidence for its use in the DSM-5 diagnosis of avoidant/restrictive food intake disorder (“a food avoidance emotional disorder”).^3,4 In retrospect, Ms. A also likely met the criteria for the diagnosis of unspecified eating disorder. Despite extensive GI workup and follow-up, physical signs of GI pathology were equivocal.

Among antipsychotics, olanzapine most closely resembles clozapine, the only antipsychotic that has been proved more efficacious than others for psychotic symptoms.⁵ There is also some research suggesting that olanzapine may be more efficacious.⁶ Obsessions and perfectionism are associated with dopamine D4 receptor activity, and D1, D2, and D3 receptors are involved in normalizing cognition and reward.⁷ There are appropriate concerns about adverse effects, especially metabolic syndrome and obesity, with olanzapine, but patients can have different profiles of receptor sensitivity. In my conversations with Ms. A’s primary care physician and GI specialist, metabolic syndrome was not an issue. Clearly, low-dose olanzapine was very helpful in her treatment.

Daniel Storch, MD
Key Point Health Services
Catonsville, Maryland

References

1. Goodnick PJ, Barrios CA. Use of olanzapine in non-psychotic psychiatric disorders. Expert Opin Pharmacother. 2001;2(4):667-680.
2. Brewerton TD. Psychopharmacologic management of eating disorders. Presented at: 25th Annual National Psychopharmacology Update; February 2020; Las Vegas, Nevada. Accessed December 8, 2020. https://legacy.audio-digest.org/pages/htmlos/pastissues.html?sub1=psychiatry&sub2=2020
3. Diagnostic and statistical manual of mental disorders, 5th ed. American Psychiatric Association; 2013.
4. Brewerton TD, D’Agostino M. Adjunctive use of olanzapine in the treatment of avoidant restrictive food intake disorder in children and adolescents in an eating disorders program. J Child Adolesc Psychopharmacol. 2017;27(10):920-922.
5. Lobos CA, Komossa K, Rummel-Kluge C, et al. Clozapine versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2010;(11):CD006633.
6. Komossa K, Rummel-Kluge C, Hunger H, et al. Olanzapine versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2010;(3):CD006654.
7. Bachner-Melman R, Lerer E, Zohar AH, et al. Anorexia nervosa, perfectionism, and dopamine D4 receptor (DRD4). Am J Med Genet B Neuropsychiatr Genet. 2007;144B(6):748-756.

Continue to: Neuro-politics and academic paralysis...

Neuro-politics and academic paralysis

I commend Dr. Nasrallah for his brief, precisely defined, scientific editorial “Neuro-politics: Will you vote with your cortex or limbic system?” (From the Editor, Current Psychiatry. October 2020, p. 14-15,63). Furthermore, he has demonstrated an admirable intellectual juggling ability to discuss politics while staying off it. This is no easy task when we witness stress, fear, and loathing from the media in the streets and academic institutes.

I would like to see Current Psychiatry and the academic psychiatric community dig deeper into what I will term as the emerging academic paralysis. Psychiatric forums and publications have been sheepish about addressing, probing, and analyzing the bitter divisions in the United States and in other nations. It appears apropos to Dr. Nasrallah’s editorial that the limbic system has trumped the prefrontal cortex. As in adolescence, this process has risks, because brain regions governing reward, impulsivity, and sensation-seeking have become—due to the choice of the “Bon Ton” political-correctness church—more influential than higher-order cognitive regions regulating behavioral inhibition, decision-making, and planning,

Similar to a hurricane or tsunami that pushes water into a river, this retro­grade shift of feedback pathways is demonstrated by emotional narratives that have flooded the public and drowned facts and evidence-based practice. Furthermore, the science of convenience has emerged, where facts are eligible only if they justify the narrative. Any discussion, debate, or questioning of the rationale of the approach is met with hostility, naming, shaming, and even loss of employment at universities. I have sadly learned from frightened colleagues and from reading reports by academicians whose publications have been either rejected or coerced for revision following acceptance by a peer-reviewed journal or even retracted post-publication due to complaints, harassment, and threats by the politically correct “thought police.” Diversity of thinking and freedom of speech—core values and principles in academic dialogue—have been violated. Academicians are as perplexed as laboratory rats that need to learn which lever to push in order to receive a reward and avoid punishment in an ever-shifting environment. People have been pondering, “Is it time for flight, fright, or fight?” As Buffalo Springfield’s legendary Vietnam 1960s–era song “For What it’s Worth” states: “There’s battle lines being drawn and nobody’s right if everybody’s wrong.”

What we have learned from history is that the majority of people exercise passivity and hope as bystanders in order to avoid becoming victims of “collateral damage.” Are there no modern Giordano Bruno (the martyr of science), Copernicus, or Michelangelo who would challenge the “Church of the People” that has created new language, terminology, and culture and is on the verge of creating nouveau scientific principles that could lead to a monopoly of one segment of society that threatens pluralism of thought. Do we need dystopic books such as 1984 or Fahrenheit 451, or the experience of the French and Russian revolution (epitomized by the guillotine and the gulag) to remind us that we are a step away from education and reprogramming camps that used to be called universities? The American Association of University Professors’ most recent announcement on academic freedom ominously avoids using terms such as freedom of speech, diversity of opinions, or even pluralism.

I hope that psychiatrists will lead the way back to sanity, starting with focus groups and forums. It would amount to a group cognitive-behavioral therapy of immense proportion following a paradigm of “Problem Solving,” according to Albert Bandura’s social learning model. There is simply no other constructive way to get to the cheese at the end of the maze.

Yifrah Kaminer, MD

Professor Emeritus of Psychiatry & Pediatrics
University of Connecticut School of Medicine
Farmington, Connecticut

Disclosures: The authors report no financial relationships with any companies whose products are mentioned in this article, or with manufacturers of competing products.

COVID-19 and decision-making capacity

Dr. Ryznar’s article “Evaluating patients’ decision-making capacity during COVID-19” (Evidence-Based Reviews, Current Psychiatry. October 2020, p. 34-40) provides a cogent overview of the “threshold” or “gradient” approach to capacity evaluations, wherein the assessment of a patient’s decisional capacity hinges on the risks and benefits of the specific clinical intervention. From a medico­legal perspective, however, I am concerned that Dr. Ryznar makes a consequential category error in framing sociopolitically-driven noncompliance with infectious disease control measures as a capacity problem. In the United States, public health powers—including the use of isolation and quarantine—fall to properly constituted public health authorities, predominantly at the state and local levels. An infectious patient with suspect ideas about coronavirus disease 2019 (COVID-19) whose decision-making process is not directly compromised by neurocognitive illness does not present a capacity issue, but rather a potential public health issue.

For example, in a controversial 2007 case in Atlanta, Georgia, an attorney with active tuberculosis failed to heed medical advice to refrain from traveling.¹ The patient’s uncooperativeness did not implicate concerns over his decisional capacity.¹ However, his international and interstate travel triggered the Centers for Disease Control and Prevention’s legal authority under the Public Health Service Act to prevent the entry and spread of communicable disease.^1-3 An authorized order from a duly constituted public health authority is issued and enforceable without regard to clinical determinations of capacity (and is generally subject to challenge via judicial or other due process mechanisms as a government-sanctioned deprivation of liberty to protect public welfare). State laws and local ordinances require physicians to notify the appropriate public health department when patients test positive for certain contagious diseases.

The difficulty with involuntarily detaining a cognitively intact patient due to concern over their contagion risk and erroneous beliefs runs considerably deeper than eliciting a “political backlash” or managing the qualms of hospital security officers. It is a fundamental matter of proper legal authority. Psychiatrists and other physicians assess patients’ decision-making capacity for specific treatment decisions on a case-by-case basis, seeking to preserve autonomy while practicing beneficence. Public health officers are agents of the state with designated authorities to control the spread of disease. A capacity determination in the absence of neurocognitive deficits implies the psychiatrist is evaluating the soundness of the patient’s ideas as opposed to their cognition, overlooking the reality that fully capable individuals can possess dubious—and even unsalutary—beliefs. While physicians educate patients about the risks of contracting and communicating infection, they are thankfully not tasked with arbitrating sociopolitical disputes at the bedside. Such controversies regarding pandemic response do not belong under the rubric of medical decision-making capacity. Conflating psychosomatic medicine consultations with public health orders risks unmooring capacity determinations from their medicolegal and bioethical foundations.

Charles G. Kels, JD
S Army Medical Center of Excellence
San Antonio, Texas  

Disclaimer: The views expressed here are those of the author and do not necessarily reflect those of any government agency.

References

1. Tanne JH. Tuberculosis case exposes flaws in international public health systems. BMJ. 2007;334(7605):1187.
2. Public Health Service Act, 42 USC § 264-272 (1944).
3. Interstate and Foreign Quarantine, 42 CFR Parts 70-71 (2017).

The author responds

I appreciate Mr. Kels’s letter and explicit discussion of the limits of decision-making capacity. I agree that physicians should not overstep their legal authority and ethical mandate. The specific case discussed in my article was a patient who was symptomatic from COVID-19 who wanted to leave the hospital against medical advice. The contagious nature of this virus certainly falls under the risk/benefit analysis of the clinical situation because it is an important aspect of understanding the nature of the illness and treatment/recovery process (as a thought example, consider that such a patient lives with their elderly mother who has heart disease and chronic obstructive pulmonary disease, and the patient does not want their mother to die). From a medico­legal perspective, the risk of infection to others may not necessarily outweigh the benefit of autonomy, especially because decision-making capacity assessments are made with the purpose of balancing autonomy and beneficence of the patient, not others. I highlighted the relative importance of autonomy using the weight of the arrows in Figure 2 of my article. I did not task physicians with arbitrating sociopolitical disputes, but merely highlighted how the current climate can impact people’s personal views on COVID-19, which sometimes can run counter to scientific evidence. If a patient has an erroneous view about an illness, it is our duty to try to help them understand if it directly impacts their health or affects their decision-making process, especially in a high-stakes clinical scenario.

Elizabeth Ryznar, MD, MSc
Assistant Professor
Department of Psychiatry and Behavioral Sciences
Johns Hopkins School of Medicine
Baltimore, Maryland

Continue to: Olanzapine for treatment-resistant anxiety

Olanzapine for treatment-resistant anxiety

Ms. A, age 62, was a retired high school teacher. Her primary care physician referred her to me for persistent, disabling anxiety. Her condition was recently worsened by a trial of escitalopram, 5 mg/d, which led her to visit the emergency department (ED). There she was prescribed lorazepam, 0.5 mg as needed, which helped her somewhat. Her medical conditions included prominent gastrointestinal (GI) symptoms, with nausea and a restricted diet; tinnitus; and chronic bilateral hand tremors. Her initial Patient Health Questionnaire-9 (PHQ-9) score was 11, and her Generalized Anxiety Disorder-7 (GAD-7) score was 10.

Initially, I encouraged Ms. A to exercise regularly, and I changed her lorazepam from 0.5 mg as-needed to 0.5 mg twice a day. I also referred her to a psychologist for psychotherapy. She showed limited improvement. I increased her lorazepam to 1 mg 3 times a day and started sertraline, 12.5 mg/d, but she soon experienced chest tightness and was admitted to the ED for observation and a cardiac workup. After she visited the ED, Ms. A stopped taking sertraline.

When I next saw Ms. A, she agreed to a trial of olanzapine, 2.5 mg/d at bedtime. Three weeks later, she told me, “I feel so much better.” Her scores on the PHQ-9 and GAD-7 were 0 and 1, respectively. Her GI complaints decreased, she had gained a little weight, and her tinnitus bothered her less. Lorazepam was gradually decreased and stopped.

After approximately 2 years, Ms. A had experienced no long-term adverse effects. We agreed to gradually discontinue olanzapine. Over the next 4 months, Ms. A decreased and stopped taking olanzapine at her own discretion.Three weeks after she stopped taking olanzapine, Ms. A reported that her psychiatric and GI symptoms had returned. She still maintained weekly visits with her psychotherapist. Her GI specialist asked if I could prescribe her olanzapine again. I restarted Ms. A on olanzapine, 2.5 mg/d at bedtime. By the next month, she said she felt much better (PHQ-9: 0; GAD-7: 1). I last saw Ms. A approximately 1 year ago.

Over the years, I have usually prescribed low-dose olanzapine alone or with other medications for patients with treatment-resistance who had no overt psychotic symptoms, I have used this medication for patients with “soft” psychotic thinking marked by severe anxiety, obsessions, compulsivity, perfectionism, and/or rumination.¹ Evidence suggests olanzapine also may be effective for anorexia nervosa.² There is good evidence for its use in the DSM-5 diagnosis of avoidant/restrictive food intake disorder (“a food avoidance emotional disorder”).^3,4 In retrospect, Ms. A also likely met the criteria for the diagnosis of unspecified eating disorder. Despite extensive GI workup and follow-up, physical signs of GI pathology were equivocal.

Among antipsychotics, olanzapine most closely resembles clozapine, the only antipsychotic that has been proved more efficacious than others for psychotic symptoms.⁵ There is also some research suggesting that olanzapine may be more efficacious.⁶ Obsessions and perfectionism are associated with dopamine D4 receptor activity, and D1, D2, and D3 receptors are involved in normalizing cognition and reward.⁷ There are appropriate concerns about adverse effects, especially metabolic syndrome and obesity, with olanzapine, but patients can have different profiles of receptor sensitivity. In my conversations with Ms. A’s primary care physician and GI specialist, metabolic syndrome was not an issue. Clearly, low-dose olanzapine was very helpful in her treatment.

Daniel Storch, MD
Key Point Health Services
Catonsville, Maryland

References

1. Goodnick PJ, Barrios CA. Use of olanzapine in non-psychotic psychiatric disorders. Expert Opin Pharmacother. 2001;2(4):667-680.
2. Brewerton TD. Psychopharmacologic management of eating disorders. Presented at: 25th Annual National Psychopharmacology Update; February 2020; Las Vegas, Nevada. Accessed December 8, 2020. https://legacy.audio-digest.org/pages/htmlos/pastissues.html?sub1=psychiatry&sub2=2020
3. Diagnostic and statistical manual of mental disorders, 5th ed. American Psychiatric Association; 2013.
4. Brewerton TD, D’Agostino M. Adjunctive use of olanzapine in the treatment of avoidant restrictive food intake disorder in children and adolescents in an eating disorders program. J Child Adolesc Psychopharmacol. 2017;27(10):920-922.
5. Lobos CA, Komossa K, Rummel-Kluge C, et al. Clozapine versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2010;(11):CD006633.
6. Komossa K, Rummel-Kluge C, Hunger H, et al. Olanzapine versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2010;(3):CD006654.
7. Bachner-Melman R, Lerer E, Zohar AH, et al. Anorexia nervosa, perfectionism, and dopamine D4 receptor (DRD4). Am J Med Genet B Neuropsychiatr Genet. 2007;144B(6):748-756.

Continue to: Neuro-politics and academic paralysis...

Neuro-politics and academic paralysis

I commend Dr. Nasrallah for his brief, precisely defined, scientific editorial “Neuro-politics: Will you vote with your cortex or limbic system?” (From the Editor, Current Psychiatry. October 2020, p. 14-15,63). Furthermore, he has demonstrated an admirable intellectual juggling ability to discuss politics while staying off it. This is no easy task when we witness stress, fear, and loathing from the media in the streets and academic institutes.

I would like to see Current Psychiatry and the academic psychiatric community dig deeper into what I will term as the emerging academic paralysis. Psychiatric forums and publications have been sheepish about addressing, probing, and analyzing the bitter divisions in the United States and in other nations. It appears apropos to Dr. Nasrallah’s editorial that the limbic system has trumped the prefrontal cortex. As in adolescence, this process has risks, because brain regions governing reward, impulsivity, and sensation-seeking have become—due to the choice of the “Bon Ton” political-correctness church—more influential than higher-order cognitive regions regulating behavioral inhibition, decision-making, and planning,

Similar to a hurricane or tsunami that pushes water into a river, this retro­grade shift of feedback pathways is demonstrated by emotional narratives that have flooded the public and drowned facts and evidence-based practice. Furthermore, the science of convenience has emerged, where facts are eligible only if they justify the narrative. Any discussion, debate, or questioning of the rationale of the approach is met with hostility, naming, shaming, and even loss of employment at universities. I have sadly learned from frightened colleagues and from reading reports by academicians whose publications have been either rejected or coerced for revision following acceptance by a peer-reviewed journal or even retracted post-publication due to complaints, harassment, and threats by the politically correct “thought police.” Diversity of thinking and freedom of speech—core values and principles in academic dialogue—have been violated. Academicians are as perplexed as laboratory rats that need to learn which lever to push in order to receive a reward and avoid punishment in an ever-shifting environment. People have been pondering, “Is it time for flight, fright, or fight?” As Buffalo Springfield’s legendary Vietnam 1960s–era song “For What it’s Worth” states: “There’s battle lines being drawn and nobody’s right if everybody’s wrong.”

What we have learned from history is that the majority of people exercise passivity and hope as bystanders in order to avoid becoming victims of “collateral damage.” Are there no modern Giordano Bruno (the martyr of science), Copernicus, or Michelangelo who would challenge the “Church of the People” that has created new language, terminology, and culture and is on the verge of creating nouveau scientific principles that could lead to a monopoly of one segment of society that threatens pluralism of thought. Do we need dystopic books such as 1984 or Fahrenheit 451, or the experience of the French and Russian revolution (epitomized by the guillotine and the gulag) to remind us that we are a step away from education and reprogramming camps that used to be called universities? The American Association of University Professors’ most recent announcement on academic freedom ominously avoids using terms such as freedom of speech, diversity of opinions, or even pluralism.

I hope that psychiatrists will lead the way back to sanity, starting with focus groups and forums. It would amount to a group cognitive-behavioral therapy of immense proportion following a paradigm of “Problem Solving,” according to Albert Bandura’s social learning model. There is simply no other constructive way to get to the cheese at the end of the maze.

Yifrah Kaminer, MD

Professor Emeritus of Psychiatry & Pediatrics
University of Connecticut School of Medicine
Farmington, Connecticut

Disclosures: The authors report no financial relationships with any companies whose products are mentioned in this article, or with manufacturers of competing products.

Clozapine is the most effective second-generation antipsychotic for the treatment of refractory schizophrenia. It can reduce delusions and hallucinations in patients who are unresponsive to other antipsychotic medications. Further, clozapine is the only agent known to reduce suicidal urges.¹

Unfortunately, clozapine is associated with numerous adverse effects, most notably agranulocytosis, a rare but potentially fatal adverse effect that occurs in approximately 1% to 2% of patients during the first year of treatment.² Other adverse effects associated with clozapine are weight gain, sedation, orthostatic hypotension, sialorrhea, constipation, hyperglycemia, hyperlipidemia, myocarditis, and seizures. Among these adverse effects, constipation, which can progress to life-threatening gastrointestinal (GI) hypomotility and ileus, is often overlooked. Up to 60% of patients who are administered clozapine experience constipation.³ A recent review found that potentially life-threatening clozapine-induced ileus occurred in approximately 3 per 1,000 patients, and 28 deaths have been documented.⁴

In this case report, I describe a patient who received clozapine and experienced constipation that led to an intestinal obstruction. I discuss the importance of prompt diagnosis and treatment approaches to prevent severe constipation in patients who are prescribed clozapine.

CASE REPORT

Mr. L, age 24, has schizophrenia, depression, mild intellectual disability, and congenital human immunodeficiency virus (HIV). He has had multiple unsuccessful antipsychotic trials but is compliant with highly active antiretroviral therapy for HIV. After experiencing worsening aggressive behavior for a third time, Mr. L was involuntarily committed to our Crises Response Center.

Mr. L was admitted to the acute inpatient psychiatry unit. He reported having auditory hallucinations, which included whispering sounds with intermittent music, mostly at night. He also reported decreased sleep, poor appetite, and low energy, but denied feelings of depression or mania.

During the mental status examination, Mr. L was calm and cooperative, but easily distracted. He said he smoked cigarettes but denied any current alcohol or illicit drug use. Mr. L’s urine drug screen was negative.

External medication records showed Mr. L had been prescribed haloperidol, risperidone, chlorpromazine, olanzapine, aripiprazole, quetiapine, bupropion, sodium valproate, and topiramate, for the treatment of schizophrenia, with no significant improvement.

Continue to: On hospital Day 3, Mr. L...

On hospital Day 3, Mr. L was started on clozapine, 12.5 mg at bedtime, and titrated to 300 mg by Day 15. The clozapine was titrated slowly; initially the dose was doubled every 2 days up to 100 mg every night at bedtime, then it was increased by 50 mg every 2 to 3 days up to 300 mg every night at bedtime. A baseline complete blood count with differential confirmed that his absolute neutrophil count (ANC) was >1,500 µL, which is above the reference range. Mr. L was closely monitored for agranulocytosis and had weekly blood work for ANC. Additionally, his information was updated regularly on the Clozapine Risk Evaluation and Mitigation Strategy website.

After Mr. L began the clozapine regimen, he had reduced mood lability, paranoia, and delusions; significantly improved auditory and visual hallucinations; and reduced distress. His sleep was improved, and he appeared pleasant with clear sensorium. During this period, Mr. L developed sialorrhea and was administered glycopyrrolate and prescribed diphenhydramine, as needed for sleep. Although he had been prescribed oral benztropine for extrapyramidal side effects prophylaxis, this medication was never administered to him during his stay in the hospital. He became stable on this regimen, and the treatment team started working on his discharge.

On hospital Day 20, Mr. L complained about abdominal pain. At first, the pain was localized to right upper quadrant; later, he had diffuse abdominal pain with distension. He reported that he had no bowel movement for 1 day. The treatment team instructed him to take nothing by mouth, and all antipsychotic and anticholinergic medications were held. Given Mr. L’s HIV status, the treatment team ordered liver function tests (LFTs) and an abdominal x-ray. Mr. L’s LFT results were normal and the x-ray findings were inconclusive. However, a CT scan of the abdomen showed an obstruction due to a 3.5-cm stoolball in the proximal transverse colon with fecal impaction. Mr. L was started on a saline enema, which resulted in him having 2 to 3 episodes of watery diarrhea, and his abdominal pain resolved.

Although Mr. L reported feeling better and started eating again, there were concerns about his watery bowel movement, so a repeat abdominal x-ray was ordered. The x-ray confirmed that Mr. L had a persistent bowel obstruction. Mr. L’s abdominal pain returned. At this time, the pain was diffuse and severe, and Mr. L was vomiting. Mr. L was started on a bisacodyl suppository immediately, and then twice daily as needed. Subsequently, Mr. L had a solid bowel movement and relief of all GI symptoms. Mr. L was administered docusate sodium twice daily. Repeated x-rays of the abdomen confirmed the obstructive changes of the small bowel had resolved.

Why constipation may be overlooked

Although constipation is a common adverse effect of many psychotropic medications, when it emerges during clozapine therapy, it can lead to ileus, which can be fatal. Mr. L’s case highlighted that clozapine use can cause intestinal obstruction, a condition that can deteriorate within a few hours to life-threatening ileus. The extent of fecal impaction can be masked by spurious diarrhea, as illustrated in Mr. L’s case.⁵ Clozapine has anti-serotonergic properties (5HT-2A antagonist) that may result in reduced intestinal nociception pain. This discrepancy between physical symptoms and the severity of illness may cause delays in diagnosis.⁴ As soon as the treatment team determined Mr. L was constipated, all medications with anticholinergic effects were held. Patients also may have difficulty reporting intestinal pain due to psychotic symptoms such as paranoia or thought disorder.⁶

Take steps to prevent constipation

To prevent constipation in patients receiving clozapine, minimize the use of systemic anticholinergic agents because of the adverse effects of this interaction. For example, in Mr. L’s case, he received both clozapine and glycopyrrolate. In addition, all patients who are prescribed clozapine should receive docusate sodium to prevent constipation. However, because docusate sodium alone is usually not sufficient, consider adding another agent. Osmotic laxatives, such as polyethylene glycol 3350, are suitable additional agents. If this combination does not work, then consider senna glycoside or bisacodyl, which will increase intestinal motility and help with the flow of water into the bowel, thereby improving constipation. Bulk agents should be avoided because they can make constipation worse, especially if the patient is not drinking enough water, which is often the case with patients who have psychosis.⁷

Ask patients about GI symptoms

Clinicians need to observe and monitor patients who receive clozapine for signs of constipation, including the frequency and difficulty of defecation during treatment.⁴ It is important to ask patients about bowel function. Before starting treatment with clozapine, discuss the risks of clozapine-induced intestinal obstruction with patients and caregivers, and encourage them to report any GI symptoms. Also, provide dietary advice and recommend the as-needed use of laxatives.

Clozapine is the most effective second-generation antipsychotic for the treatment of refractory schizophrenia. It can reduce delusions and hallucinations in patients who are unresponsive to other antipsychotic medications. Further, clozapine is the only agent known to reduce suicidal urges.¹

Unfortunately, clozapine is associated with numerous adverse effects, most notably agranulocytosis, a rare but potentially fatal adverse effect that occurs in approximately 1% to 2% of patients during the first year of treatment.² Other adverse effects associated with clozapine are weight gain, sedation, orthostatic hypotension, sialorrhea, constipation, hyperglycemia, hyperlipidemia, myocarditis, and seizures. Among these adverse effects, constipation, which can progress to life-threatening gastrointestinal (GI) hypomotility and ileus, is often overlooked. Up to 60% of patients who are administered clozapine experience constipation.³ A recent review found that potentially life-threatening clozapine-induced ileus occurred in approximately 3 per 1,000 patients, and 28 deaths have been documented.⁴

In this case report, I describe a patient who received clozapine and experienced constipation that led to an intestinal obstruction. I discuss the importance of prompt diagnosis and treatment approaches to prevent severe constipation in patients who are prescribed clozapine.

CASE REPORT

Mr. L, age 24, has schizophrenia, depression, mild intellectual disability, and congenital human immunodeficiency virus (HIV). He has had multiple unsuccessful antipsychotic trials but is compliant with highly active antiretroviral therapy for HIV. After experiencing worsening aggressive behavior for a third time, Mr. L was involuntarily committed to our Crises Response Center.

Mr. L was admitted to the acute inpatient psychiatry unit. He reported having auditory hallucinations, which included whispering sounds with intermittent music, mostly at night. He also reported decreased sleep, poor appetite, and low energy, but denied feelings of depression or mania.

During the mental status examination, Mr. L was calm and cooperative, but easily distracted. He said he smoked cigarettes but denied any current alcohol or illicit drug use. Mr. L’s urine drug screen was negative.

External medication records showed Mr. L had been prescribed haloperidol, risperidone, chlorpromazine, olanzapine, aripiprazole, quetiapine, bupropion, sodium valproate, and topiramate, for the treatment of schizophrenia, with no significant improvement.

Continue to: On hospital Day 3, Mr. L...

On hospital Day 3, Mr. L was started on clozapine, 12.5 mg at bedtime, and titrated to 300 mg by Day 15. The clozapine was titrated slowly; initially the dose was doubled every 2 days up to 100 mg every night at bedtime, then it was increased by 50 mg every 2 to 3 days up to 300 mg every night at bedtime. A baseline complete blood count with differential confirmed that his absolute neutrophil count (ANC) was >1,500 µL, which is above the reference range. Mr. L was closely monitored for agranulocytosis and had weekly blood work for ANC. Additionally, his information was updated regularly on the Clozapine Risk Evaluation and Mitigation Strategy website.

After Mr. L began the clozapine regimen, he had reduced mood lability, paranoia, and delusions; significantly improved auditory and visual hallucinations; and reduced distress. His sleep was improved, and he appeared pleasant with clear sensorium. During this period, Mr. L developed sialorrhea and was administered glycopyrrolate and prescribed diphenhydramine, as needed for sleep. Although he had been prescribed oral benztropine for extrapyramidal side effects prophylaxis, this medication was never administered to him during his stay in the hospital. He became stable on this regimen, and the treatment team started working on his discharge.

On hospital Day 20, Mr. L complained about abdominal pain. At first, the pain was localized to right upper quadrant; later, he had diffuse abdominal pain with distension. He reported that he had no bowel movement for 1 day. The treatment team instructed him to take nothing by mouth, and all antipsychotic and anticholinergic medications were held. Given Mr. L’s HIV status, the treatment team ordered liver function tests (LFTs) and an abdominal x-ray. Mr. L’s LFT results were normal and the x-ray findings were inconclusive. However, a CT scan of the abdomen showed an obstruction due to a 3.5-cm stoolball in the proximal transverse colon with fecal impaction. Mr. L was started on a saline enema, which resulted in him having 2 to 3 episodes of watery diarrhea, and his abdominal pain resolved.

Although Mr. L reported feeling better and started eating again, there were concerns about his watery bowel movement, so a repeat abdominal x-ray was ordered. The x-ray confirmed that Mr. L had a persistent bowel obstruction. Mr. L’s abdominal pain returned. At this time, the pain was diffuse and severe, and Mr. L was vomiting. Mr. L was started on a bisacodyl suppository immediately, and then twice daily as needed. Subsequently, Mr. L had a solid bowel movement and relief of all GI symptoms. Mr. L was administered docusate sodium twice daily. Repeated x-rays of the abdomen confirmed the obstructive changes of the small bowel had resolved.

Why constipation may be overlooked

Although constipation is a common adverse effect of many psychotropic medications, when it emerges during clozapine therapy, it can lead to ileus, which can be fatal. Mr. L’s case highlighted that clozapine use can cause intestinal obstruction, a condition that can deteriorate within a few hours to life-threatening ileus. The extent of fecal impaction can be masked by spurious diarrhea, as illustrated in Mr. L’s case.⁵ Clozapine has anti-serotonergic properties (5HT-2A antagonist) that may result in reduced intestinal nociception pain. This discrepancy between physical symptoms and the severity of illness may cause delays in diagnosis.⁴ As soon as the treatment team determined Mr. L was constipated, all medications with anticholinergic effects were held. Patients also may have difficulty reporting intestinal pain due to psychotic symptoms such as paranoia or thought disorder.⁶

Take steps to prevent constipation

To prevent constipation in patients receiving clozapine, minimize the use of systemic anticholinergic agents because of the adverse effects of this interaction. For example, in Mr. L’s case, he received both clozapine and glycopyrrolate. In addition, all patients who are prescribed clozapine should receive docusate sodium to prevent constipation. However, because docusate sodium alone is usually not sufficient, consider adding another agent. Osmotic laxatives, such as polyethylene glycol 3350, are suitable additional agents. If this combination does not work, then consider senna glycoside or bisacodyl, which will increase intestinal motility and help with the flow of water into the bowel, thereby improving constipation. Bulk agents should be avoided because they can make constipation worse, especially if the patient is not drinking enough water, which is often the case with patients who have psychosis.⁷

Ask patients about GI symptoms

Clinicians need to observe and monitor patients who receive clozapine for signs of constipation, including the frequency and difficulty of defecation during treatment.⁴ It is important to ask patients about bowel function. Before starting treatment with clozapine, discuss the risks of clozapine-induced intestinal obstruction with patients and caregivers, and encourage them to report any GI symptoms. Also, provide dietary advice and recommend the as-needed use of laxatives.

Clozapine is the most effective second-generation antipsychotic for the treatment of refractory schizophrenia. It can reduce delusions and hallucinations in patients who are unresponsive to other antipsychotic medications. Further, clozapine is the only agent known to reduce suicidal urges.¹

Unfortunately, clozapine is associated with numerous adverse effects, most notably agranulocytosis, a rare but potentially fatal adverse effect that occurs in approximately 1% to 2% of patients during the first year of treatment.² Other adverse effects associated with clozapine are weight gain, sedation, orthostatic hypotension, sialorrhea, constipation, hyperglycemia, hyperlipidemia, myocarditis, and seizures. Among these adverse effects, constipation, which can progress to life-threatening gastrointestinal (GI) hypomotility and ileus, is often overlooked. Up to 60% of patients who are administered clozapine experience constipation.³ A recent review found that potentially life-threatening clozapine-induced ileus occurred in approximately 3 per 1,000 patients, and 28 deaths have been documented.⁴

In this case report, I describe a patient who received clozapine and experienced constipation that led to an intestinal obstruction. I discuss the importance of prompt diagnosis and treatment approaches to prevent severe constipation in patients who are prescribed clozapine.

CASE REPORT

Mr. L, age 24, has schizophrenia, depression, mild intellectual disability, and congenital human immunodeficiency virus (HIV). He has had multiple unsuccessful antipsychotic trials but is compliant with highly active antiretroviral therapy for HIV. After experiencing worsening aggressive behavior for a third time, Mr. L was involuntarily committed to our Crises Response Center.

Mr. L was admitted to the acute inpatient psychiatry unit. He reported having auditory hallucinations, which included whispering sounds with intermittent music, mostly at night. He also reported decreased sleep, poor appetite, and low energy, but denied feelings of depression or mania.

During the mental status examination, Mr. L was calm and cooperative, but easily distracted. He said he smoked cigarettes but denied any current alcohol or illicit drug use. Mr. L’s urine drug screen was negative.

External medication records showed Mr. L had been prescribed haloperidol, risperidone, chlorpromazine, olanzapine, aripiprazole, quetiapine, bupropion, sodium valproate, and topiramate, for the treatment of schizophrenia, with no significant improvement.

Continue to: On hospital Day 3, Mr. L...

On hospital Day 3, Mr. L was started on clozapine, 12.5 mg at bedtime, and titrated to 300 mg by Day 15. The clozapine was titrated slowly; initially the dose was doubled every 2 days up to 100 mg every night at bedtime, then it was increased by 50 mg every 2 to 3 days up to 300 mg every night at bedtime. A baseline complete blood count with differential confirmed that his absolute neutrophil count (ANC) was >1,500 µL, which is above the reference range. Mr. L was closely monitored for agranulocytosis and had weekly blood work for ANC. Additionally, his information was updated regularly on the Clozapine Risk Evaluation and Mitigation Strategy website.

After Mr. L began the clozapine regimen, he had reduced mood lability, paranoia, and delusions; significantly improved auditory and visual hallucinations; and reduced distress. His sleep was improved, and he appeared pleasant with clear sensorium. During this period, Mr. L developed sialorrhea and was administered glycopyrrolate and prescribed diphenhydramine, as needed for sleep. Although he had been prescribed oral benztropine for extrapyramidal side effects prophylaxis, this medication was never administered to him during his stay in the hospital. He became stable on this regimen, and the treatment team started working on his discharge.

On hospital Day 20, Mr. L complained about abdominal pain. At first, the pain was localized to right upper quadrant; later, he had diffuse abdominal pain with distension. He reported that he had no bowel movement for 1 day. The treatment team instructed him to take nothing by mouth, and all antipsychotic and anticholinergic medications were held. Given Mr. L’s HIV status, the treatment team ordered liver function tests (LFTs) and an abdominal x-ray. Mr. L’s LFT results were normal and the x-ray findings were inconclusive. However, a CT scan of the abdomen showed an obstruction due to a 3.5-cm stoolball in the proximal transverse colon with fecal impaction. Mr. L was started on a saline enema, which resulted in him having 2 to 3 episodes of watery diarrhea, and his abdominal pain resolved.

Although Mr. L reported feeling better and started eating again, there were concerns about his watery bowel movement, so a repeat abdominal x-ray was ordered. The x-ray confirmed that Mr. L had a persistent bowel obstruction. Mr. L’s abdominal pain returned. At this time, the pain was diffuse and severe, and Mr. L was vomiting. Mr. L was started on a bisacodyl suppository immediately, and then twice daily as needed. Subsequently, Mr. L had a solid bowel movement and relief of all GI symptoms. Mr. L was administered docusate sodium twice daily. Repeated x-rays of the abdomen confirmed the obstructive changes of the small bowel had resolved.

Why constipation may be overlooked

Although constipation is a common adverse effect of many psychotropic medications, when it emerges during clozapine therapy, it can lead to ileus, which can be fatal. Mr. L’s case highlighted that clozapine use can cause intestinal obstruction, a condition that can deteriorate within a few hours to life-threatening ileus. The extent of fecal impaction can be masked by spurious diarrhea, as illustrated in Mr. L’s case.⁵ Clozapine has anti-serotonergic properties (5HT-2A antagonist) that may result in reduced intestinal nociception pain. This discrepancy between physical symptoms and the severity of illness may cause delays in diagnosis.⁴ As soon as the treatment team determined Mr. L was constipated, all medications with anticholinergic effects were held. Patients also may have difficulty reporting intestinal pain due to psychotic symptoms such as paranoia or thought disorder.⁶

Take steps to prevent constipation

To prevent constipation in patients receiving clozapine, minimize the use of systemic anticholinergic agents because of the adverse effects of this interaction. For example, in Mr. L’s case, he received both clozapine and glycopyrrolate. In addition, all patients who are prescribed clozapine should receive docusate sodium to prevent constipation. However, because docusate sodium alone is usually not sufficient, consider adding another agent. Osmotic laxatives, such as polyethylene glycol 3350, are suitable additional agents. If this combination does not work, then consider senna glycoside or bisacodyl, which will increase intestinal motility and help with the flow of water into the bowel, thereby improving constipation. Bulk agents should be avoided because they can make constipation worse, especially if the patient is not drinking enough water, which is often the case with patients who have psychosis.⁷

Ask patients about GI symptoms

Clinicians need to observe and monitor patients who receive clozapine for signs of constipation, including the frequency and difficulty of defecation during treatment.⁴ It is important to ask patients about bowel function. Before starting treatment with clozapine, discuss the risks of clozapine-induced intestinal obstruction with patients and caregivers, and encourage them to report any GI symptoms. Also, provide dietary advice and recommend the as-needed use of laxatives.

Hospitalists have played a central role in the massive response to the coronavirus disease 2019 (COVID-19) pandemic by creating innovative staffing models, rapidly learning about the disease and teaching others, and working closely with hospital executive leadership to create surge capacity.¹ Some hospitals and regions have weathered an initial storm and are now experiencing a slower influx of COVID-19 patients, while others are now seeing a surge, which is expected to persist for the foreseeable future—the marathon has begun.² We have entered a new COVID-19 reality: disrupted care models, harsh financial consequences,³ and uncertainty about which adaptations should be preserved and for how long. Common operational challenges will define the new normal. In this Perspective, we share strategies to address these challenges, focusing on three emerging themes: realigning staffing to patient volumes, safely managing space limitations, and navigating the financial ramifications of COVID-19 for hospital medicine groups.

Hospital medicine groups face uncertainty about future patient volumes and their characteristics. It is unclear when, how, or even whether hospital medicine groups should return to “normal” pre-COVID staffing models. The following principles can guide staffing decisions.

First, maintain nonhospitalist backup pools and define triggers to activate these providers. Despite the impulse to return to prior staffing models, this recovery period provides an opportunity for leaders to create transparent activation protocols and provide additional training to enable seamless backup. In preparation for a surge, our hospital medicine group quickly assembled an emergency staffing pool composed of advanced practice providers, primary care providers, medicine subspecialists, and surgeons who were prepared to temporarily assume unfamiliar roles. Thankfully, we were able to manage our COVID-19 patients without much emergency hospitalist staffing, but for other hospitals with larger community outbreaks, the emergency backup workforce proved invaluable.

Second, use appropriate safeguards and delegate certain aspects of COVID-related care to other healthcare team members. As staff are deployed and redeployed, consider how inter­professional team members can be reintegrated into evaluation and triage protocols. For example, registered nurses can determine appropriate isolation precautions for patients with COVID and patients under investigation.

Third, consider hospital-specific specialty care patterns when planning for COVID-19 redeployment to ensure access to equally critical, nonelective services. For example, Level 1 trauma centers may expect seasonal increases in trauma patient volumes, so consider staffing trauma teams (including surgeons, anesthesiologists, and operating room staff) for their usual roles to prevent critical coverage gaps. Concurrently, hospital medicine consulting and comanagement teams must also be available to support the trauma service. These staffing needs affect who will be available for redeployment for future COVID-related care.

As the number of COVID cases increased, numerous hospitals created geographic “hot zones” with defined cold (uncontaminated), warm (transitional), and hot (contaminated) areas by either partitioning off a section of an acute care medical ward or repurposing an entire ward as a COVID-19 unit, and similar zones were made in intensive care units. Hot zones required significant early investments to change infrastructure, including equipping rooms for negative pressurization with HEPA filtration towers and training staff on safety protocols for entering these spaces, performing necessary patient care, and exiting. Ultimately, these investments proved worthwhile and allowed for decreased personal protective equipment (PPE) use, as well as improved efficiency and staff safety. However, as hospitals ramp up non-COVID care, deciding how to best reconfigure or downsize these hot zones has become challenging.

With time to regroup, the newly experienced end users of hot zones—hospitalists, other staff who worked in these spaces, and patients—must be included in discussions with engineers, architects, and administrators regarding future construction. Hot zone plans should specifically address how physical separation of COVID and non-COVID patients will be maintained while providing safe and efficient care. With elective surgeries increasing and non-COVID patients returning to hospitals, leaders must consider the psychological effects that seeing hospital staff doffing PPE and crossing an invisible barrier to a ‘‘cold” area of the floor has on patients and their families. It is important to maintain hot zones in areas that can dynamically flex to accommodate waves of the current and future pandemics, especially because hospitals may be asked to care for patients from overwhelmed distant sites even if the pandemic is locally controlled. We are experimenting with modifications to hospital traffic patterns including “no pass through” zones, one-way hallways, and separate entries and exits to clinical floors for COVID and non-COVID patients. With vigilant adherence to infection prevention guidelines and PPE use, we have not seen hospital-­acquired infections with this model of care.

Modifying space and flow patterns also enables clustered care for COVID patients, which allows for the temporary use of modular teams.⁴ This tactic may be especially useful during surge periods, during which PPE conservation is paramount and isolating cohorts of providers provides an extra layer of safety. In the longer run, however, isolating providers from their peers risks worsening morale and increasing burnout.

The path forward must ensure safety but also allow for a financially sustainable balance of COVID and non-COVID care. To prepare for surges, health systems canceled elective surgeries and other services that generate essential revenue. At both private and public hospitals, systemwide measures have been taken to mitigate these financial losses. These measures have included salary, retirement, and continuing medical education benefit reductions for physicians and senior leadership; limits to physician hiring and recruitment; leaner operations with systemwide expense reductions; and mandatory and voluntary staff furloughs. The frontline hospital staff, including physicians, nurses, technologists, and food and environmental service workers, who have made great sacrifices during this pandemic, may also now be facing significant personal financial consequences.

The following recommendations are offered from the perspective that crisis creates opportunity for hospital medicine leaders grappling with budget shortfalls.

First, maximize budget transparency by explicitly defining the principles and priorities that govern budget decisions, which allows hospitalist group members to understand how the organization determines budget cuts. For example, stating that a key priority is to minimize staff layoffs makes consequent salary reductions more understandable.

Second, solicit hospital medicine group members’ input on these shared challenges and invite their help in identifying and prioritizing potential cost-saving or cost-cutting measures.

Third, highlight hospitalists’ nonfiscal contributions, especially in terms of crisis leadership, to continue engagement with executive leaders.⁵ This may include a dialogue about the disproportionate influence of work relative value unit production on salary and about how to create compensation systems that can also recognize crisis readiness as an important feature of sustainability and quality care. The next pandemic surge may be weeks or months away, and hospitalists will again need to be leaders in the response.

Fourth, use this crisis to foster fiscal innovation and accelerate participation in value improvement work, such as redesigning pay-for-performance metrics. Financially strapped institutions will value hospitalists who are good financial stewards. For example, leverage hospitalist expertise in progression of care to facilitate timely disposition of COVID patients, thereby minimizing costly extended hospitalizations.

Lastly, hospital medicine groups must match staffing to patient volume to the extent possible. Approximately two-thirds of hospitalist groups entered this crisis already understaffed and partially reliant on moonlighters,⁶ which allowed some variation of labor expenses to match lower patient volume. During the recovery phase, hospital volumes may either be significantly below or above baseline; many patients are understandably avoiding hospitals due to fear of COVID. However, delayed care may create a different kind of peak demand for services. For hospitalists, uncertainty about expected clinical roles, COVID vs non-COVID patient mix, and patient volume can be stressful. We recommend sustained, frequent communication about census trends and how shifts will be covered to ensure adequate, long-term staffing. Maintaining trust and morale will be equally, if not more, important in the next phase.

As we settle into the marathon, hospital medicine leadership must balance competing priorities with increasing finesse. Our hospital medicine group has benefited from continually discussing operational challenges and refining our strategies as we plan for what is ahead. We have highlighted three mission-critical themes and recommend that hospital and hospital medicine group leaders remain mindful of these challenges and potential strategies. Each of our four academic hospitals has considered similar trade-offs and will proceed along slightly different trajectories to meet unique needs. Looking to the future, we anticipate additional challenges requiring greater ongoing attention alongside those already identified. These include mitigating provider burnout, optimizing resident and student education, and maintaining scholarly work as COVID unpredictably waxes and wanes. By accumulating confidence and wisdom about post-COVID hospital medicine group functions, we hope to provide hospitalists with the energy to keep the pace in the next phase of the marathon.

Hospitalists have played a central role in the massive response to the coronavirus disease 2019 (COVID-19) pandemic by creating innovative staffing models, rapidly learning about the disease and teaching others, and working closely with hospital executive leadership to create surge capacity.¹ Some hospitals and regions have weathered an initial storm and are now experiencing a slower influx of COVID-19 patients, while others are now seeing a surge, which is expected to persist for the foreseeable future—the marathon has begun.² We have entered a new COVID-19 reality: disrupted care models, harsh financial consequences,³ and uncertainty about which adaptations should be preserved and for how long. Common operational challenges will define the new normal. In this Perspective, we share strategies to address these challenges, focusing on three emerging themes: realigning staffing to patient volumes, safely managing space limitations, and navigating the financial ramifications of COVID-19 for hospital medicine groups.

Hospital medicine groups face uncertainty about future patient volumes and their characteristics. It is unclear when, how, or even whether hospital medicine groups should return to “normal” pre-COVID staffing models. The following principles can guide staffing decisions.

First, maintain nonhospitalist backup pools and define triggers to activate these providers. Despite the impulse to return to prior staffing models, this recovery period provides an opportunity for leaders to create transparent activation protocols and provide additional training to enable seamless backup. In preparation for a surge, our hospital medicine group quickly assembled an emergency staffing pool composed of advanced practice providers, primary care providers, medicine subspecialists, and surgeons who were prepared to temporarily assume unfamiliar roles. Thankfully, we were able to manage our COVID-19 patients without much emergency hospitalist staffing, but for other hospitals with larger community outbreaks, the emergency backup workforce proved invaluable.

Second, use appropriate safeguards and delegate certain aspects of COVID-related care to other healthcare team members. As staff are deployed and redeployed, consider how inter­professional team members can be reintegrated into evaluation and triage protocols. For example, registered nurses can determine appropriate isolation precautions for patients with COVID and patients under investigation.

Third, consider hospital-specific specialty care patterns when planning for COVID-19 redeployment to ensure access to equally critical, nonelective services. For example, Level 1 trauma centers may expect seasonal increases in trauma patient volumes, so consider staffing trauma teams (including surgeons, anesthesiologists, and operating room staff) for their usual roles to prevent critical coverage gaps. Concurrently, hospital medicine consulting and comanagement teams must also be available to support the trauma service. These staffing needs affect who will be available for redeployment for future COVID-related care.

As the number of COVID cases increased, numerous hospitals created geographic “hot zones” with defined cold (uncontaminated), warm (transitional), and hot (contaminated) areas by either partitioning off a section of an acute care medical ward or repurposing an entire ward as a COVID-19 unit, and similar zones were made in intensive care units. Hot zones required significant early investments to change infrastructure, including equipping rooms for negative pressurization with HEPA filtration towers and training staff on safety protocols for entering these spaces, performing necessary patient care, and exiting. Ultimately, these investments proved worthwhile and allowed for decreased personal protective equipment (PPE) use, as well as improved efficiency and staff safety. However, as hospitals ramp up non-COVID care, deciding how to best reconfigure or downsize these hot zones has become challenging.

With time to regroup, the newly experienced end users of hot zones—hospitalists, other staff who worked in these spaces, and patients—must be included in discussions with engineers, architects, and administrators regarding future construction. Hot zone plans should specifically address how physical separation of COVID and non-COVID patients will be maintained while providing safe and efficient care. With elective surgeries increasing and non-COVID patients returning to hospitals, leaders must consider the psychological effects that seeing hospital staff doffing PPE and crossing an invisible barrier to a ‘‘cold” area of the floor has on patients and their families. It is important to maintain hot zones in areas that can dynamically flex to accommodate waves of the current and future pandemics, especially because hospitals may be asked to care for patients from overwhelmed distant sites even if the pandemic is locally controlled. We are experimenting with modifications to hospital traffic patterns including “no pass through” zones, one-way hallways, and separate entries and exits to clinical floors for COVID and non-COVID patients. With vigilant adherence to infection prevention guidelines and PPE use, we have not seen hospital-­acquired infections with this model of care.

Modifying space and flow patterns also enables clustered care for COVID patients, which allows for the temporary use of modular teams.⁴ This tactic may be especially useful during surge periods, during which PPE conservation is paramount and isolating cohorts of providers provides an extra layer of safety. In the longer run, however, isolating providers from their peers risks worsening morale and increasing burnout.

The path forward must ensure safety but also allow for a financially sustainable balance of COVID and non-COVID care. To prepare for surges, health systems canceled elective surgeries and other services that generate essential revenue. At both private and public hospitals, systemwide measures have been taken to mitigate these financial losses. These measures have included salary, retirement, and continuing medical education benefit reductions for physicians and senior leadership; limits to physician hiring and recruitment; leaner operations with systemwide expense reductions; and mandatory and voluntary staff furloughs. The frontline hospital staff, including physicians, nurses, technologists, and food and environmental service workers, who have made great sacrifices during this pandemic, may also now be facing significant personal financial consequences.

The following recommendations are offered from the perspective that crisis creates opportunity for hospital medicine leaders grappling with budget shortfalls.

First, maximize budget transparency by explicitly defining the principles and priorities that govern budget decisions, which allows hospitalist group members to understand how the organization determines budget cuts. For example, stating that a key priority is to minimize staff layoffs makes consequent salary reductions more understandable.

Second, solicit hospital medicine group members’ input on these shared challenges and invite their help in identifying and prioritizing potential cost-saving or cost-cutting measures.

Third, highlight hospitalists’ nonfiscal contributions, especially in terms of crisis leadership, to continue engagement with executive leaders.⁵ This may include a dialogue about the disproportionate influence of work relative value unit production on salary and about how to create compensation systems that can also recognize crisis readiness as an important feature of sustainability and quality care. The next pandemic surge may be weeks or months away, and hospitalists will again need to be leaders in the response.

Fourth, use this crisis to foster fiscal innovation and accelerate participation in value improvement work, such as redesigning pay-for-performance metrics. Financially strapped institutions will value hospitalists who are good financial stewards. For example, leverage hospitalist expertise in progression of care to facilitate timely disposition of COVID patients, thereby minimizing costly extended hospitalizations.

Lastly, hospital medicine groups must match staffing to patient volume to the extent possible. Approximately two-thirds of hospitalist groups entered this crisis already understaffed and partially reliant on moonlighters,⁶ which allowed some variation of labor expenses to match lower patient volume. During the recovery phase, hospital volumes may either be significantly below or above baseline; many patients are understandably avoiding hospitals due to fear of COVID. However, delayed care may create a different kind of peak demand for services. For hospitalists, uncertainty about expected clinical roles, COVID vs non-COVID patient mix, and patient volume can be stressful. We recommend sustained, frequent communication about census trends and how shifts will be covered to ensure adequate, long-term staffing. Maintaining trust and morale will be equally, if not more, important in the next phase.

As we settle into the marathon, hospital medicine leadership must balance competing priorities with increasing finesse. Our hospital medicine group has benefited from continually discussing operational challenges and refining our strategies as we plan for what is ahead. We have highlighted three mission-critical themes and recommend that hospital and hospital medicine group leaders remain mindful of these challenges and potential strategies. Each of our four academic hospitals has considered similar trade-offs and will proceed along slightly different trajectories to meet unique needs. Looking to the future, we anticipate additional challenges requiring greater ongoing attention alongside those already identified. These include mitigating provider burnout, optimizing resident and student education, and maintaining scholarly work as COVID unpredictably waxes and wanes. By accumulating confidence and wisdom about post-COVID hospital medicine group functions, we hope to provide hospitalists with the energy to keep the pace in the next phase of the marathon.

Hospitalists have played a central role in the massive response to the coronavirus disease 2019 (COVID-19) pandemic by creating innovative staffing models, rapidly learning about the disease and teaching others, and working closely with hospital executive leadership to create surge capacity.¹ Some hospitals and regions have weathered an initial storm and are now experiencing a slower influx of COVID-19 patients, while others are now seeing a surge, which is expected to persist for the foreseeable future—the marathon has begun.² We have entered a new COVID-19 reality: disrupted care models, harsh financial consequences,³ and uncertainty about which adaptations should be preserved and for how long. Common operational challenges will define the new normal. In this Perspective, we share strategies to address these challenges, focusing on three emerging themes: realigning staffing to patient volumes, safely managing space limitations, and navigating the financial ramifications of COVID-19 for hospital medicine groups.

Hospital medicine groups face uncertainty about future patient volumes and their characteristics. It is unclear when, how, or even whether hospital medicine groups should return to “normal” pre-COVID staffing models. The following principles can guide staffing decisions.

First, maintain nonhospitalist backup pools and define triggers to activate these providers. Despite the impulse to return to prior staffing models, this recovery period provides an opportunity for leaders to create transparent activation protocols and provide additional training to enable seamless backup. In preparation for a surge, our hospital medicine group quickly assembled an emergency staffing pool composed of advanced practice providers, primary care providers, medicine subspecialists, and surgeons who were prepared to temporarily assume unfamiliar roles. Thankfully, we were able to manage our COVID-19 patients without much emergency hospitalist staffing, but for other hospitals with larger community outbreaks, the emergency backup workforce proved invaluable.

Second, use appropriate safeguards and delegate certain aspects of COVID-related care to other healthcare team members. As staff are deployed and redeployed, consider how inter­professional team members can be reintegrated into evaluation and triage protocols. For example, registered nurses can determine appropriate isolation precautions for patients with COVID and patients under investigation.

Third, consider hospital-specific specialty care patterns when planning for COVID-19 redeployment to ensure access to equally critical, nonelective services. For example, Level 1 trauma centers may expect seasonal increases in trauma patient volumes, so consider staffing trauma teams (including surgeons, anesthesiologists, and operating room staff) for their usual roles to prevent critical coverage gaps. Concurrently, hospital medicine consulting and comanagement teams must also be available to support the trauma service. These staffing needs affect who will be available for redeployment for future COVID-related care.

As the number of COVID cases increased, numerous hospitals created geographic “hot zones” with defined cold (uncontaminated), warm (transitional), and hot (contaminated) areas by either partitioning off a section of an acute care medical ward or repurposing an entire ward as a COVID-19 unit, and similar zones were made in intensive care units. Hot zones required significant early investments to change infrastructure, including equipping rooms for negative pressurization with HEPA filtration towers and training staff on safety protocols for entering these spaces, performing necessary patient care, and exiting. Ultimately, these investments proved worthwhile and allowed for decreased personal protective equipment (PPE) use, as well as improved efficiency and staff safety. However, as hospitals ramp up non-COVID care, deciding how to best reconfigure or downsize these hot zones has become challenging.

With time to regroup, the newly experienced end users of hot zones—hospitalists, other staff who worked in these spaces, and patients—must be included in discussions with engineers, architects, and administrators regarding future construction. Hot zone plans should specifically address how physical separation of COVID and non-COVID patients will be maintained while providing safe and efficient care. With elective surgeries increasing and non-COVID patients returning to hospitals, leaders must consider the psychological effects that seeing hospital staff doffing PPE and crossing an invisible barrier to a ‘‘cold” area of the floor has on patients and their families. It is important to maintain hot zones in areas that can dynamically flex to accommodate waves of the current and future pandemics, especially because hospitals may be asked to care for patients from overwhelmed distant sites even if the pandemic is locally controlled. We are experimenting with modifications to hospital traffic patterns including “no pass through” zones, one-way hallways, and separate entries and exits to clinical floors for COVID and non-COVID patients. With vigilant adherence to infection prevention guidelines and PPE use, we have not seen hospital-­acquired infections with this model of care.

Modifying space and flow patterns also enables clustered care for COVID patients, which allows for the temporary use of modular teams.⁴ This tactic may be especially useful during surge periods, during which PPE conservation is paramount and isolating cohorts of providers provides an extra layer of safety. In the longer run, however, isolating providers from their peers risks worsening morale and increasing burnout.

The path forward must ensure safety but also allow for a financially sustainable balance of COVID and non-COVID care. To prepare for surges, health systems canceled elective surgeries and other services that generate essential revenue. At both private and public hospitals, systemwide measures have been taken to mitigate these financial losses. These measures have included salary, retirement, and continuing medical education benefit reductions for physicians and senior leadership; limits to physician hiring and recruitment; leaner operations with systemwide expense reductions; and mandatory and voluntary staff furloughs. The frontline hospital staff, including physicians, nurses, technologists, and food and environmental service workers, who have made great sacrifices during this pandemic, may also now be facing significant personal financial consequences.

The following recommendations are offered from the perspective that crisis creates opportunity for hospital medicine leaders grappling with budget shortfalls.

First, maximize budget transparency by explicitly defining the principles and priorities that govern budget decisions, which allows hospitalist group members to understand how the organization determines budget cuts. For example, stating that a key priority is to minimize staff layoffs makes consequent salary reductions more understandable.

Second, solicit hospital medicine group members’ input on these shared challenges and invite their help in identifying and prioritizing potential cost-saving or cost-cutting measures.

Third, highlight hospitalists’ nonfiscal contributions, especially in terms of crisis leadership, to continue engagement with executive leaders.⁵ This may include a dialogue about the disproportionate influence of work relative value unit production on salary and about how to create compensation systems that can also recognize crisis readiness as an important feature of sustainability and quality care. The next pandemic surge may be weeks or months away, and hospitalists will again need to be leaders in the response.

Fourth, use this crisis to foster fiscal innovation and accelerate participation in value improvement work, such as redesigning pay-for-performance metrics. Financially strapped institutions will value hospitalists who are good financial stewards. For example, leverage hospitalist expertise in progression of care to facilitate timely disposition of COVID patients, thereby minimizing costly extended hospitalizations.

Lastly, hospital medicine groups must match staffing to patient volume to the extent possible. Approximately two-thirds of hospitalist groups entered this crisis already understaffed and partially reliant on moonlighters,⁶ which allowed some variation of labor expenses to match lower patient volume. During the recovery phase, hospital volumes may either be significantly below or above baseline; many patients are understandably avoiding hospitals due to fear of COVID. However, delayed care may create a different kind of peak demand for services. For hospitalists, uncertainty about expected clinical roles, COVID vs non-COVID patient mix, and patient volume can be stressful. We recommend sustained, frequent communication about census trends and how shifts will be covered to ensure adequate, long-term staffing. Maintaining trust and morale will be equally, if not more, important in the next phase.

As we settle into the marathon, hospital medicine leadership must balance competing priorities with increasing finesse. Our hospital medicine group has benefited from continually discussing operational challenges and refining our strategies as we plan for what is ahead. We have highlighted three mission-critical themes and recommend that hospital and hospital medicine group leaders remain mindful of these challenges and potential strategies. Each of our four academic hospitals has considered similar trade-offs and will proceed along slightly different trajectories to meet unique needs. Looking to the future, we anticipate additional challenges requiring greater ongoing attention alongside those already identified. These include mitigating provider burnout, optimizing resident and student education, and maintaining scholarly work as COVID unpredictably waxes and wanes. By accumulating confidence and wisdom about post-COVID hospital medicine group functions, we hope to provide hospitalists with the energy to keep the pace in the next phase of the marathon.

The rapid onset of the novel coronavirus disease 2019 (COVID-19) pandemic forced the US healthcare system to scramble to prepare for a health crisis with many unknowns. Early on, it was unclear exactly how the virus was transmitted, how many people would fall ill or how ill they would get, what treatments would be most efficacious, and what resources were needed to care for patients.¹ Given the short window the healthcare system had to prepare, many initial and important decisions were made quickly and often at a local level, with limited coordination and standardization across localities and organizations. These decisions included what services could be offered, how best to allocate potentially scarce resources (such as personal protective equipment and ventilators), and how much surge capacity to build.^2,3 In short, many of the early decisions about the pandemic were understandably varied, and the lack of standardized metrics to help guide decision-making did not help the situation.

Unfortunately, as the COVID-19 pandemic continues, there has been insufficient movement toward standardizing definitions for many key measures needed to manage the public health response. Even small differences in definitions can have important implications for decision-making.⁴ For example, public health officials have recommended communities achieve a positivity rate of 5% or lower for 14 straight days before easing virus-related restrictions.⁵ In Maryland, two different entities are calculating positivity rates for the state using different methodologies and producing different results, which can have significant public health and economic implications for the state. Johns Hopkins University’s Resource Center calculates the positivity rate by comparing the number of people who tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to all people who were tested. This method consistently produces a positivity rate for Maryland above the 5% threshold. In contrast, the state of Maryland calculates the positivity rate by comparing the number of positive tests for SARS-CoV-2 to the number of tests conducted, even if the same person had multiple tests (unless the tests are performed the same day at the same location). This method consistently produces a positivity rate for Maryland below the 5% threshold.⁶

The lack of standardized definitions leads not only to debate and confusion over what steps to take next, but also opens the door to politicization of pandemic data. This is readily apparent when considering mortality due to COVID-19. For example, different states use different definitions for COVID-19 mortality. Alabama defines COVID-19 mortality by only including patients who tested positive for the SARS-CoV-2 virus and the cause of death was attributed to COVID-19. In contrast, Colorado’s COVID-19 mortality definition includes those patients who are believed to have died of COVID-19, but does not require confirmation of SARS-CoV-2 infection by a positive test.⁷ Further compounding the challenge, some politicians reference the COVID-19 mortality rate as a comparison of those who died from COVID-19 with those who were sick with COVID-19, reflecting the success rate of treating patients with COVID-19, an area in which the United States has done relatively well compared with other countries. This definition of the mortality rate suits a narrative of successful pandemic management.⁸ However, many public health officials suggest the COVID-19 mortality rate should be defined by comparing the number of deaths from COVID-19 as a percentage of the population, which reflects the percentage of the population dying from the disease. In this regard, the United States has not done as well relative to other countries.⁹ These different definitions highlight how the United States lacks a standardized way to compare its performance across states and with other countries, even on a straightforward measure like mortality.

The lack of clarity on, and politicization of, pandemic data demonstrate the need to take stock of what metrics require standardization to help public health officials and health system leaders manage the pandemic response moving forward. The Table provides examples of currently used metrics that would benefit from better standardization to inform decision-making across a broad range of settings, including public health, hospitals, physician clinics, and nursing homes. For example, a commonly referenced metric during the pandemic has been a moving average of the incidence rate of positive COVID-19 cases in a defined geographic area (eg, a state).^10,11 This data point is helpful to healthcare delivery organizations for understanding the change in COVID-19 cases in their cities and states, which can inform planning on whether or not to continue elective surgeries or how many beds need to be kept in reserve status for a potential surge of hospitalizations. But there has not been a consensus around whether the reporting of COVID-19 positive tests should reflect the day the test was performed or the day the test results were available. The day the test results were available can be influenced by lengthy or uneven turnaround times for the results (eg, backlogs in labs) and can paint a false picture of trends with the virus.

As another example, knowing the percentage of the population that has tested positive for COVID-19 can help inform both resource planning and reopening decisions. But there has been variation in whether counts of positive COVID-19 tests should only include antigen tests, or antibody tests as well. This exact question played out when the Centers for Disease Control and Prevention (CDC) made decisions that differed from those of many states about whether to include antibody tests in their publicly announced COVID-19 testing numbers,¹² perhaps undermining public confidence in the reported data.

To capture currently unstandardized metrics with broad applicability, the United States should form a consensus task force to identify and define metrics and, over time, refine them based on current science and public health priorities. The task force would require a mix of individuals with various skill sets, such as expertise in infectious diseases and epidemiology, healthcare operations, statistics, performance measurement, and public health. The US Department of Health and Human Services is likely the appropriate sponsor, with representation from the National Institutes of Health, the CDC, and the Agency for Healthcare Research and Quality, in partnership with national provider and public health group representatives.

Once standardized definitions for metrics have been agreed upon, the metric definitions will need to be made readily available to the public and healthcare organizations. Standardization will permit collection of electronic health records for quick calculation and review, with an output of dashboards for reporting. It would also prevent every public health and healthcare delivery organization from having to define its own metrics, freeing them up to focus on planning. Several metrics already have standard definitions, and those metrics have proven useful for decision-making. For example, there is agreement that the turnaround time for a SARS-CoV-2 test is measured by the difference in time between when the test was performed and when the test results were available. This standard definition allows for performance comparisons across different laboratories within the same service area and comparisons across different regions of the country. Once the metrics are standardized, public health leaders and healthcare organizations can use variation in performance and outcomes to identify leading indicators for planning.

Amid the COVID-19 pandemic, the US healthcare system finds itself in a state of managing uncertainty for a prolonged period of time. The unprecedented nature of this crisis means that best practices will not always be clear. Providing access to clearly defined, standardized metrics will be essential to public health officials and healthcare organization leaders’ ability to manage through this pandemic. The risk of not moving in this direction means forcing leaders to make decisions without the best information available. Good data will be essential to guiding the US healthcare system through this extraordinary crisis.

The rapid onset of the novel coronavirus disease 2019 (COVID-19) pandemic forced the US healthcare system to scramble to prepare for a health crisis with many unknowns. Early on, it was unclear exactly how the virus was transmitted, how many people would fall ill or how ill they would get, what treatments would be most efficacious, and what resources were needed to care for patients.¹ Given the short window the healthcare system had to prepare, many initial and important decisions were made quickly and often at a local level, with limited coordination and standardization across localities and organizations. These decisions included what services could be offered, how best to allocate potentially scarce resources (such as personal protective equipment and ventilators), and how much surge capacity to build.^2,3 In short, many of the early decisions about the pandemic were understandably varied, and the lack of standardized metrics to help guide decision-making did not help the situation.

Unfortunately, as the COVID-19 pandemic continues, there has been insufficient movement toward standardizing definitions for many key measures needed to manage the public health response. Even small differences in definitions can have important implications for decision-making.⁴ For example, public health officials have recommended communities achieve a positivity rate of 5% or lower for 14 straight days before easing virus-related restrictions.⁵ In Maryland, two different entities are calculating positivity rates for the state using different methodologies and producing different results, which can have significant public health and economic implications for the state. Johns Hopkins University’s Resource Center calculates the positivity rate by comparing the number of people who tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to all people who were tested. This method consistently produces a positivity rate for Maryland above the 5% threshold. In contrast, the state of Maryland calculates the positivity rate by comparing the number of positive tests for SARS-CoV-2 to the number of tests conducted, even if the same person had multiple tests (unless the tests are performed the same day at the same location). This method consistently produces a positivity rate for Maryland below the 5% threshold.⁶

The lack of standardized definitions leads not only to debate and confusion over what steps to take next, but also opens the door to politicization of pandemic data. This is readily apparent when considering mortality due to COVID-19. For example, different states use different definitions for COVID-19 mortality. Alabama defines COVID-19 mortality by only including patients who tested positive for the SARS-CoV-2 virus and the cause of death was attributed to COVID-19. In contrast, Colorado’s COVID-19 mortality definition includes those patients who are believed to have died of COVID-19, but does not require confirmation of SARS-CoV-2 infection by a positive test.⁷ Further compounding the challenge, some politicians reference the COVID-19 mortality rate as a comparison of those who died from COVID-19 with those who were sick with COVID-19, reflecting the success rate of treating patients with COVID-19, an area in which the United States has done relatively well compared with other countries. This definition of the mortality rate suits a narrative of successful pandemic management.⁸ However, many public health officials suggest the COVID-19 mortality rate should be defined by comparing the number of deaths from COVID-19 as a percentage of the population, which reflects the percentage of the population dying from the disease. In this regard, the United States has not done as well relative to other countries.⁹ These different definitions highlight how the United States lacks a standardized way to compare its performance across states and with other countries, even on a straightforward measure like mortality.

The lack of clarity on, and politicization of, pandemic data demonstrate the need to take stock of what metrics require standardization to help public health officials and health system leaders manage the pandemic response moving forward. The Table provides examples of currently used metrics that would benefit from better standardization to inform decision-making across a broad range of settings, including public health, hospitals, physician clinics, and nursing homes. For example, a commonly referenced metric during the pandemic has been a moving average of the incidence rate of positive COVID-19 cases in a defined geographic area (eg, a state).^10,11 This data point is helpful to healthcare delivery organizations for understanding the change in COVID-19 cases in their cities and states, which can inform planning on whether or not to continue elective surgeries or how many beds need to be kept in reserve status for a potential surge of hospitalizations. But there has not been a consensus around whether the reporting of COVID-19 positive tests should reflect the day the test was performed or the day the test results were available. The day the test results were available can be influenced by lengthy or uneven turnaround times for the results (eg, backlogs in labs) and can paint a false picture of trends with the virus.

As another example, knowing the percentage of the population that has tested positive for COVID-19 can help inform both resource planning and reopening decisions. But there has been variation in whether counts of positive COVID-19 tests should only include antigen tests, or antibody tests as well. This exact question played out when the Centers for Disease Control and Prevention (CDC) made decisions that differed from those of many states about whether to include antibody tests in their publicly announced COVID-19 testing numbers,¹² perhaps undermining public confidence in the reported data.

To capture currently unstandardized metrics with broad applicability, the United States should form a consensus task force to identify and define metrics and, over time, refine them based on current science and public health priorities. The task force would require a mix of individuals with various skill sets, such as expertise in infectious diseases and epidemiology, healthcare operations, statistics, performance measurement, and public health. The US Department of Health and Human Services is likely the appropriate sponsor, with representation from the National Institutes of Health, the CDC, and the Agency for Healthcare Research and Quality, in partnership with national provider and public health group representatives.

Once standardized definitions for metrics have been agreed upon, the metric definitions will need to be made readily available to the public and healthcare organizations. Standardization will permit collection of electronic health records for quick calculation and review, with an output of dashboards for reporting. It would also prevent every public health and healthcare delivery organization from having to define its own metrics, freeing them up to focus on planning. Several metrics already have standard definitions, and those metrics have proven useful for decision-making. For example, there is agreement that the turnaround time for a SARS-CoV-2 test is measured by the difference in time between when the test was performed and when the test results were available. This standard definition allows for performance comparisons across different laboratories within the same service area and comparisons across different regions of the country. Once the metrics are standardized, public health leaders and healthcare organizations can use variation in performance and outcomes to identify leading indicators for planning.

Amid the COVID-19 pandemic, the US healthcare system finds itself in a state of managing uncertainty for a prolonged period of time. The unprecedented nature of this crisis means that best practices will not always be clear. Providing access to clearly defined, standardized metrics will be essential to public health officials and healthcare organization leaders’ ability to manage through this pandemic. The risk of not moving in this direction means forcing leaders to make decisions without the best information available. Good data will be essential to guiding the US healthcare system through this extraordinary crisis.

The rapid onset of the novel coronavirus disease 2019 (COVID-19) pandemic forced the US healthcare system to scramble to prepare for a health crisis with many unknowns. Early on, it was unclear exactly how the virus was transmitted, how many people would fall ill or how ill they would get, what treatments would be most efficacious, and what resources were needed to care for patients.¹ Given the short window the healthcare system had to prepare, many initial and important decisions were made quickly and often at a local level, with limited coordination and standardization across localities and organizations. These decisions included what services could be offered, how best to allocate potentially scarce resources (such as personal protective equipment and ventilators), and how much surge capacity to build.^2,3 In short, many of the early decisions about the pandemic were understandably varied, and the lack of standardized metrics to help guide decision-making did not help the situation.

Unfortunately, as the COVID-19 pandemic continues, there has been insufficient movement toward standardizing definitions for many key measures needed to manage the public health response. Even small differences in definitions can have important implications for decision-making.⁴ For example, public health officials have recommended communities achieve a positivity rate of 5% or lower for 14 straight days before easing virus-related restrictions.⁵ In Maryland, two different entities are calculating positivity rates for the state using different methodologies and producing different results, which can have significant public health and economic implications for the state. Johns Hopkins University’s Resource Center calculates the positivity rate by comparing the number of people who tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to all people who were tested. This method consistently produces a positivity rate for Maryland above the 5% threshold. In contrast, the state of Maryland calculates the positivity rate by comparing the number of positive tests for SARS-CoV-2 to the number of tests conducted, even if the same person had multiple tests (unless the tests are performed the same day at the same location). This method consistently produces a positivity rate for Maryland below the 5% threshold.⁶

The lack of standardized definitions leads not only to debate and confusion over what steps to take next, but also opens the door to politicization of pandemic data. This is readily apparent when considering mortality due to COVID-19. For example, different states use different definitions for COVID-19 mortality. Alabama defines COVID-19 mortality by only including patients who tested positive for the SARS-CoV-2 virus and the cause of death was attributed to COVID-19. In contrast, Colorado’s COVID-19 mortality definition includes those patients who are believed to have died of COVID-19, but does not require confirmation of SARS-CoV-2 infection by a positive test.⁷ Further compounding the challenge, some politicians reference the COVID-19 mortality rate as a comparison of those who died from COVID-19 with those who were sick with COVID-19, reflecting the success rate of treating patients with COVID-19, an area in which the United States has done relatively well compared with other countries. This definition of the mortality rate suits a narrative of successful pandemic management.⁸ However, many public health officials suggest the COVID-19 mortality rate should be defined by comparing the number of deaths from COVID-19 as a percentage of the population, which reflects the percentage of the population dying from the disease. In this regard, the United States has not done as well relative to other countries.⁹ These different definitions highlight how the United States lacks a standardized way to compare its performance across states and with other countries, even on a straightforward measure like mortality.

The lack of clarity on, and politicization of, pandemic data demonstrate the need to take stock of what metrics require standardization to help public health officials and health system leaders manage the pandemic response moving forward. The Table provides examples of currently used metrics that would benefit from better standardization to inform decision-making across a broad range of settings, including public health, hospitals, physician clinics, and nursing homes. For example, a commonly referenced metric during the pandemic has been a moving average of the incidence rate of positive COVID-19 cases in a defined geographic area (eg, a state).^10,11 This data point is helpful to healthcare delivery organizations for understanding the change in COVID-19 cases in their cities and states, which can inform planning on whether or not to continue elective surgeries or how many beds need to be kept in reserve status for a potential surge of hospitalizations. But there has not been a consensus around whether the reporting of COVID-19 positive tests should reflect the day the test was performed or the day the test results were available. The day the test results were available can be influenced by lengthy or uneven turnaround times for the results (eg, backlogs in labs) and can paint a false picture of trends with the virus.

As another example, knowing the percentage of the population that has tested positive for COVID-19 can help inform both resource planning and reopening decisions. But there has been variation in whether counts of positive COVID-19 tests should only include antigen tests, or antibody tests as well. This exact question played out when the Centers for Disease Control and Prevention (CDC) made decisions that differed from those of many states about whether to include antibody tests in their publicly announced COVID-19 testing numbers,¹² perhaps undermining public confidence in the reported data.

To capture currently unstandardized metrics with broad applicability, the United States should form a consensus task force to identify and define metrics and, over time, refine them based on current science and public health priorities. The task force would require a mix of individuals with various skill sets, such as expertise in infectious diseases and epidemiology, healthcare operations, statistics, performance measurement, and public health. The US Department of Health and Human Services is likely the appropriate sponsor, with representation from the National Institutes of Health, the CDC, and the Agency for Healthcare Research and Quality, in partnership with national provider and public health group representatives.

Once standardized definitions for metrics have been agreed upon, the metric definitions will need to be made readily available to the public and healthcare organizations. Standardization will permit collection of electronic health records for quick calculation and review, with an output of dashboards for reporting. It would also prevent every public health and healthcare delivery organization from having to define its own metrics, freeing them up to focus on planning. Several metrics already have standard definitions, and those metrics have proven useful for decision-making. For example, there is agreement that the turnaround time for a SARS-CoV-2 test is measured by the difference in time between when the test was performed and when the test results were available. This standard definition allows for performance comparisons across different laboratories within the same service area and comparisons across different regions of the country. Once the metrics are standardized, public health leaders and healthcare organizations can use variation in performance and outcomes to identify leading indicators for planning.

Amid the COVID-19 pandemic, the US healthcare system finds itself in a state of managing uncertainty for a prolonged period of time. The unprecedented nature of this crisis means that best practices will not always be clear. Providing access to clearly defined, standardized metrics will be essential to public health officials and healthcare organization leaders’ ability to manage through this pandemic. The risk of not moving in this direction means forcing leaders to make decisions without the best information available. Good data will be essential to guiding the US healthcare system through this extraordinary crisis.

The novel coronavirus disease of 2019 (COVID-19), caused by the SARS-CoV-2 pathogen, has resulted in a health crisis unlike any other experienced in the past century, with millions of people infected and over one million people dying from COVID-19 worldwide. The pandemic has disproportionately impacted historically marginalized groups, resulting in higher rates of infection, hospitalization, and death in racial/ethnic minority populations, including Black, Hispanic/Latinx, and Native American populations, compared with the White population.¹ Statistics suggest that it is not just socioeconomic differences but also structural racism that has played a role in worse health outcomes in minority populations. However, the health inequities uncovered by the pandemic represent an opportunity—a “plastic hour” in which improvements at the population level may be uniquely possible.² As healthcare providers, we must take advantage of this moment and work toward improving healthcare and increasing health equity in the post–COVID-19 era. We highlight three strategies to guide us toward achieving this goal: (1) prioritizing health system equity and government improvements to population health, (2) fostering community resilience, and (3) promoting equity in economic sustainability.

The COVID-19 pandemic has revealed deep-seated structural and medical vulnerabilities in the US healthcare system, with distressing racial/ethnic differences in COVID-19 infection continuing to emerge.³ Despite variation in the availability and quality of these data, disparities observed in COVID-19 have tracked closely with historical inequities in access to healthcare and discrimination within the healthcare system.⁴ Any approach to addressing these inequities must appreciate the intersection between social and medical vulnerabilities.

It is notable that healthcare systems serving the most vulnerable populations have borne the brunt of the economic toll of COVID-19. Hospitals in socioeconomically challenged areas lost millions of dollars due to the postponement of elective procedures and reallocation of most resources to COVID-related hospital admissions. Many community-based practices, already stretched in caring for medically and socially complex patients, had to shut their doors. These losses have left patients without the support of their network of healthcare and community service organizations—at the same time that many of them have also lost support for food and housing, employer-based health insurance, and in-person schooling and childcare.

The current circumstances due to the COVID-19 pandemic, therefore, require us to reconsider many aspects of both healthcare and the social safety net, including the reliance on financial penalties as a strategy to improve health quality, which ultimately has a disproportionate impact on communities of color.⁵ The present situation may also allow for the federal, state, and local governments, as well as health systems and payers, to make targeted investments in healthcare, public health, and community programs. For example, an increased healthcare system investment on preventive and primary care will be essential to reducing the chronic risk factors that underlie COVID-19 infection and death. Efforts by payers to reduce economic incentives for unnecessary elective procedures, while simultaneously providing incentives to increase the focus on preventive care, would further stimulate this effort. Although there is controversy over the inclusion of social risk in financial and value-based health system payment models, novel approaches to this problem (eg, consideration of improvement over achievement of static targets) may provide an opportunity for struggling health systems to invest in new strategies for underserved populations. Additionally, investing in a care system that allows racial, language, and cultural concordance between clinicians and patients would both promote a diverse workforce and improve quality of care. Health system equity will also depend upon bold policy advances such as expansion of Medicaid to all states, separation of health insurance from employment, and targeted government and health system investments around social risk (eg, food and housing insecurity). These programs will help vulnerable communities close the gap on disparities in health outcomes that have been so persistent.

Some of these specific concerns were addressed by the Coronavirus Aid, Relief, and Economic Security (CARES) Act that was implemented by the US Congress to address the broad needs of Americans during the acute crisis.⁶ The CARES Act provided supplementary funding to community health centers and healthcare systems caring for the uninsured. Cash assistance was provided to most US taxpayers along with financial support to those experiencing unemployment through July 31, 2020, measures that have yet to be extended. In addition to the CARES Act, policymakers proposed establishing a COVID-19 Racial and Ethnic Disparities Task Force Act to drive equitable recommendations and provide oversight to the nation’s response to COVID-19.⁷

While these measures were critical to the immediate pandemic response, future US congressional relief plans are needed to ensure equity remains a tenet of state and federal policy post COVID-19, particularly with respect to social determinants of health. Additional recommendations for federal relief include rent assistance for low-income families, eviction stoppages, and increased funding for short-term food insecurity. With respect to long-term goals, this is the time to address broader injustices, such as lack of affordable housing, lack of a sensible national strategy around food security, and a lack of equitable educational and justice systems. This moment also offers an opportunity to consider the best way to address the impact of centuries of structural racism. If we place equity at the center of policy implementation, we will certainly see downstream health consequences—ones that would begin to address the health disparities present long before the current pandemic.

While national, state, and local responses to COVID-19 are required to bolster population health when we emerge from the COVID-19 crisis, a focus on community resilience is also needed. Community resilience, or the ability to prevent, withstand, and mitigate the stress of a disaster like COVID-19, requires integration of emergency preparedness practices into community disaster programs, with ongoing efforts to mitigate disparities in chronic disease management. A framework for community resilience includes (1) engaging with communities in planning, response, and post–COVID-19 recovery, (2) ensuring communities have access to high quality, culturally concordant health and social services, and (3) developing robust community networks to mobilize individuals, community services, and public health infrastructure in times of emergency.⁸

After seeing the devastating effects of Hurricane Katrina in 2005, researchers, public health officials, and community leaders founded the Los Angeles County Community Disaster Resilience (LACCDR) project. Through this collaborative effort, the LACCDR established partnerships across 16 communities to foster community resilience during health emergencies against the backdrop of daily chronic stressors such as violence, segregation, poverty, and homelessness.⁸ A model such as this to improve health systems and public health integration post-COVID will support health provisions and help build trust in communities wherein there is a high distrust of the healthcare system. Engaging with community partners early to ensure that its members have access to basic needs (eg, food, water, shelter), public health needs (eg, timely information, personal protective equipment such as face coverings and cleaning supplies), and affordable testing and vaccination will help prevent disparities that could affect the most vulnerable in future phases of the COVID-19 crisis.

Over 40 million Americans were seeking unemployment benefits at the peak of the economic repercussions of the COVID-19 pandemic. Unfortunately, low-income, rural, and minority communities disproportionately experienced this economic shock. Given the relationship between wealth and health, successfully achieving equity post-COVID-19 will require deeper financial investments in underserved communities.⁹ Healthcare organizations, which represent 18% of the United States gross domestic product and employ nearly 9% of all working individuals, are uniquely positioned to have a direct influence on this strategy.

One equity-based strategy is for healthcare institutions to pursue an anchor mission. Anchor missions have increased a health system’s investment in social services, including providing housing and food resources.¹⁰ Additionally, hospitals such as Brigham and Women’s, Boston Children’s Hospital, and Bon Secours Health System, are working with a diverse group of entrepreneurs to create jobs and build wealth in underserved communities by employing local and minority-owned businesses to support critical supply chain purchasing decisions regarding food, maintenance, and construction projects.¹¹ These local and inclusive hiring and procurement measures can be bolstered by continued place-based investments by all health system leaders in vulnerable communities.

Since the first enslaved Africans were brought to America over 400 years ago, racial and ethnic minorities have experienced struggle and triumph, sadness and joy. The bonds of a long legacy of discrimination are so deep that we must be intentional in our pursuit of equity—during and beyond the COVID-19 pandemic. Placing equity at the center of healthcare system practice and policy implementation, fostering community resilience and emergency preparedness, and prioritizing equity in economic strategic planning are key steps toward addressing the population-level inequities exposed by the COVID-19 pandemic. As the once touted “great equalizer” rages on, we must remember that we are all jointly affected by the distress caused by the novel coronavirus and we also must be more aware than ever of our interconnectedness. We can use this time of pandemic to fight more than ever to ensure that all populations can enjoy just and optimal health.

The authors would like to thank Dr Denise Polit for her review of this manuscript.

The novel coronavirus disease of 2019 (COVID-19), caused by the SARS-CoV-2 pathogen, has resulted in a health crisis unlike any other experienced in the past century, with millions of people infected and over one million people dying from COVID-19 worldwide. The pandemic has disproportionately impacted historically marginalized groups, resulting in higher rates of infection, hospitalization, and death in racial/ethnic minority populations, including Black, Hispanic/Latinx, and Native American populations, compared with the White population.¹ Statistics suggest that it is not just socioeconomic differences but also structural racism that has played a role in worse health outcomes in minority populations. However, the health inequities uncovered by the pandemic represent an opportunity—a “plastic hour” in which improvements at the population level may be uniquely possible.² As healthcare providers, we must take advantage of this moment and work toward improving healthcare and increasing health equity in the post–COVID-19 era. We highlight three strategies to guide us toward achieving this goal: (1) prioritizing health system equity and government improvements to population health, (2) fostering community resilience, and (3) promoting equity in economic sustainability.

The COVID-19 pandemic has revealed deep-seated structural and medical vulnerabilities in the US healthcare system, with distressing racial/ethnic differences in COVID-19 infection continuing to emerge.³ Despite variation in the availability and quality of these data, disparities observed in COVID-19 have tracked closely with historical inequities in access to healthcare and discrimination within the healthcare system.⁴ Any approach to addressing these inequities must appreciate the intersection between social and medical vulnerabilities.

It is notable that healthcare systems serving the most vulnerable populations have borne the brunt of the economic toll of COVID-19. Hospitals in socioeconomically challenged areas lost millions of dollars due to the postponement of elective procedures and reallocation of most resources to COVID-related hospital admissions. Many community-based practices, already stretched in caring for medically and socially complex patients, had to shut their doors. These losses have left patients without the support of their network of healthcare and community service organizations—at the same time that many of them have also lost support for food and housing, employer-based health insurance, and in-person schooling and childcare.

The current circumstances due to the COVID-19 pandemic, therefore, require us to reconsider many aspects of both healthcare and the social safety net, including the reliance on financial penalties as a strategy to improve health quality, which ultimately has a disproportionate impact on communities of color.⁵ The present situation may also allow for the federal, state, and local governments, as well as health systems and payers, to make targeted investments in healthcare, public health, and community programs. For example, an increased healthcare system investment on preventive and primary care will be essential to reducing the chronic risk factors that underlie COVID-19 infection and death. Efforts by payers to reduce economic incentives for unnecessary elective procedures, while simultaneously providing incentives to increase the focus on preventive care, would further stimulate this effort. Although there is controversy over the inclusion of social risk in financial and value-based health system payment models, novel approaches to this problem (eg, consideration of improvement over achievement of static targets) may provide an opportunity for struggling health systems to invest in new strategies for underserved populations. Additionally, investing in a care system that allows racial, language, and cultural concordance between clinicians and patients would both promote a diverse workforce and improve quality of care. Health system equity will also depend upon bold policy advances such as expansion of Medicaid to all states, separation of health insurance from employment, and targeted government and health system investments around social risk (eg, food and housing insecurity). These programs will help vulnerable communities close the gap on disparities in health outcomes that have been so persistent.

Some of these specific concerns were addressed by the Coronavirus Aid, Relief, and Economic Security (CARES) Act that was implemented by the US Congress to address the broad needs of Americans during the acute crisis.⁶ The CARES Act provided supplementary funding to community health centers and healthcare systems caring for the uninsured. Cash assistance was provided to most US taxpayers along with financial support to those experiencing unemployment through July 31, 2020, measures that have yet to be extended. In addition to the CARES Act, policymakers proposed establishing a COVID-19 Racial and Ethnic Disparities Task Force Act to drive equitable recommendations and provide oversight to the nation’s response to COVID-19.⁷

While these measures were critical to the immediate pandemic response, future US congressional relief plans are needed to ensure equity remains a tenet of state and federal policy post COVID-19, particularly with respect to social determinants of health. Additional recommendations for federal relief include rent assistance for low-income families, eviction stoppages, and increased funding for short-term food insecurity. With respect to long-term goals, this is the time to address broader injustices, such as lack of affordable housing, lack of a sensible national strategy around food security, and a lack of equitable educational and justice systems. This moment also offers an opportunity to consider the best way to address the impact of centuries of structural racism. If we place equity at the center of policy implementation, we will certainly see downstream health consequences—ones that would begin to address the health disparities present long before the current pandemic.

While national, state, and local responses to COVID-19 are required to bolster population health when we emerge from the COVID-19 crisis, a focus on community resilience is also needed. Community resilience, or the ability to prevent, withstand, and mitigate the stress of a disaster like COVID-19, requires integration of emergency preparedness practices into community disaster programs, with ongoing efforts to mitigate disparities in chronic disease management. A framework for community resilience includes (1) engaging with communities in planning, response, and post–COVID-19 recovery, (2) ensuring communities have access to high quality, culturally concordant health and social services, and (3) developing robust community networks to mobilize individuals, community services, and public health infrastructure in times of emergency.⁸

After seeing the devastating effects of Hurricane Katrina in 2005, researchers, public health officials, and community leaders founded the Los Angeles County Community Disaster Resilience (LACCDR) project. Through this collaborative effort, the LACCDR established partnerships across 16 communities to foster community resilience during health emergencies against the backdrop of daily chronic stressors such as violence, segregation, poverty, and homelessness.⁸ A model such as this to improve health systems and public health integration post-COVID will support health provisions and help build trust in communities wherein there is a high distrust of the healthcare system. Engaging with community partners early to ensure that its members have access to basic needs (eg, food, water, shelter), public health needs (eg, timely information, personal protective equipment such as face coverings and cleaning supplies), and affordable testing and vaccination will help prevent disparities that could affect the most vulnerable in future phases of the COVID-19 crisis.

Over 40 million Americans were seeking unemployment benefits at the peak of the economic repercussions of the COVID-19 pandemic. Unfortunately, low-income, rural, and minority communities disproportionately experienced this economic shock. Given the relationship between wealth and health, successfully achieving equity post-COVID-19 will require deeper financial investments in underserved communities.⁹ Healthcare organizations, which represent 18% of the United States gross domestic product and employ nearly 9% of all working individuals, are uniquely positioned to have a direct influence on this strategy.

One equity-based strategy is for healthcare institutions to pursue an anchor mission. Anchor missions have increased a health system’s investment in social services, including providing housing and food resources.¹⁰ Additionally, hospitals such as Brigham and Women’s, Boston Children’s Hospital, and Bon Secours Health System, are working with a diverse group of entrepreneurs to create jobs and build wealth in underserved communities by employing local and minority-owned businesses to support critical supply chain purchasing decisions regarding food, maintenance, and construction projects.¹¹ These local and inclusive hiring and procurement measures can be bolstered by continued place-based investments by all health system leaders in vulnerable communities.

Since the first enslaved Africans were brought to America over 400 years ago, racial and ethnic minorities have experienced struggle and triumph, sadness and joy. The bonds of a long legacy of discrimination are so deep that we must be intentional in our pursuit of equity—during and beyond the COVID-19 pandemic. Placing equity at the center of healthcare system practice and policy implementation, fostering community resilience and emergency preparedness, and prioritizing equity in economic strategic planning are key steps toward addressing the population-level inequities exposed by the COVID-19 pandemic. As the once touted “great equalizer” rages on, we must remember that we are all jointly affected by the distress caused by the novel coronavirus and we also must be more aware than ever of our interconnectedness. We can use this time of pandemic to fight more than ever to ensure that all populations can enjoy just and optimal health.

The authors would like to thank Dr Denise Polit for her review of this manuscript.

The novel coronavirus disease of 2019 (COVID-19), caused by the SARS-CoV-2 pathogen, has resulted in a health crisis unlike any other experienced in the past century, with millions of people infected and over one million people dying from COVID-19 worldwide. The pandemic has disproportionately impacted historically marginalized groups, resulting in higher rates of infection, hospitalization, and death in racial/ethnic minority populations, including Black, Hispanic/Latinx, and Native American populations, compared with the White population.¹ Statistics suggest that it is not just socioeconomic differences but also structural racism that has played a role in worse health outcomes in minority populations. However, the health inequities uncovered by the pandemic represent an opportunity—a “plastic hour” in which improvements at the population level may be uniquely possible.² As healthcare providers, we must take advantage of this moment and work toward improving healthcare and increasing health equity in the post–COVID-19 era. We highlight three strategies to guide us toward achieving this goal: (1) prioritizing health system equity and government improvements to population health, (2) fostering community resilience, and (3) promoting equity in economic sustainability.

The COVID-19 pandemic has revealed deep-seated structural and medical vulnerabilities in the US healthcare system, with distressing racial/ethnic differences in COVID-19 infection continuing to emerge.³ Despite variation in the availability and quality of these data, disparities observed in COVID-19 have tracked closely with historical inequities in access to healthcare and discrimination within the healthcare system.⁴ Any approach to addressing these inequities must appreciate the intersection between social and medical vulnerabilities.

It is notable that healthcare systems serving the most vulnerable populations have borne the brunt of the economic toll of COVID-19. Hospitals in socioeconomically challenged areas lost millions of dollars due to the postponement of elective procedures and reallocation of most resources to COVID-related hospital admissions. Many community-based practices, already stretched in caring for medically and socially complex patients, had to shut their doors. These losses have left patients without the support of their network of healthcare and community service organizations—at the same time that many of them have also lost support for food and housing, employer-based health insurance, and in-person schooling and childcare.

The current circumstances due to the COVID-19 pandemic, therefore, require us to reconsider many aspects of both healthcare and the social safety net, including the reliance on financial penalties as a strategy to improve health quality, which ultimately has a disproportionate impact on communities of color.⁵ The present situation may also allow for the federal, state, and local governments, as well as health systems and payers, to make targeted investments in healthcare, public health, and community programs. For example, an increased healthcare system investment on preventive and primary care will be essential to reducing the chronic risk factors that underlie COVID-19 infection and death. Efforts by payers to reduce economic incentives for unnecessary elective procedures, while simultaneously providing incentives to increase the focus on preventive care, would further stimulate this effort. Although there is controversy over the inclusion of social risk in financial and value-based health system payment models, novel approaches to this problem (eg, consideration of improvement over achievement of static targets) may provide an opportunity for struggling health systems to invest in new strategies for underserved populations. Additionally, investing in a care system that allows racial, language, and cultural concordance between clinicians and patients would both promote a diverse workforce and improve quality of care. Health system equity will also depend upon bold policy advances such as expansion of Medicaid to all states, separation of health insurance from employment, and targeted government and health system investments around social risk (eg, food and housing insecurity). These programs will help vulnerable communities close the gap on disparities in health outcomes that have been so persistent.

Some of these specific concerns were addressed by the Coronavirus Aid, Relief, and Economic Security (CARES) Act that was implemented by the US Congress to address the broad needs of Americans during the acute crisis.⁶ The CARES Act provided supplementary funding to community health centers and healthcare systems caring for the uninsured. Cash assistance was provided to most US taxpayers along with financial support to those experiencing unemployment through July 31, 2020, measures that have yet to be extended. In addition to the CARES Act, policymakers proposed establishing a COVID-19 Racial and Ethnic Disparities Task Force Act to drive equitable recommendations and provide oversight to the nation’s response to COVID-19.⁷

While these measures were critical to the immediate pandemic response, future US congressional relief plans are needed to ensure equity remains a tenet of state and federal policy post COVID-19, particularly with respect to social determinants of health. Additional recommendations for federal relief include rent assistance for low-income families, eviction stoppages, and increased funding for short-term food insecurity. With respect to long-term goals, this is the time to address broader injustices, such as lack of affordable housing, lack of a sensible national strategy around food security, and a lack of equitable educational and justice systems. This moment also offers an opportunity to consider the best way to address the impact of centuries of structural racism. If we place equity at the center of policy implementation, we will certainly see downstream health consequences—ones that would begin to address the health disparities present long before the current pandemic.

While national, state, and local responses to COVID-19 are required to bolster population health when we emerge from the COVID-19 crisis, a focus on community resilience is also needed. Community resilience, or the ability to prevent, withstand, and mitigate the stress of a disaster like COVID-19, requires integration of emergency preparedness practices into community disaster programs, with ongoing efforts to mitigate disparities in chronic disease management. A framework for community resilience includes (1) engaging with communities in planning, response, and post–COVID-19 recovery, (2) ensuring communities have access to high quality, culturally concordant health and social services, and (3) developing robust community networks to mobilize individuals, community services, and public health infrastructure in times of emergency.⁸

After seeing the devastating effects of Hurricane Katrina in 2005, researchers, public health officials, and community leaders founded the Los Angeles County Community Disaster Resilience (LACCDR) project. Through this collaborative effort, the LACCDR established partnerships across 16 communities to foster community resilience during health emergencies against the backdrop of daily chronic stressors such as violence, segregation, poverty, and homelessness.⁸ A model such as this to improve health systems and public health integration post-COVID will support health provisions and help build trust in communities wherein there is a high distrust of the healthcare system. Engaging with community partners early to ensure that its members have access to basic needs (eg, food, water, shelter), public health needs (eg, timely information, personal protective equipment such as face coverings and cleaning supplies), and affordable testing and vaccination will help prevent disparities that could affect the most vulnerable in future phases of the COVID-19 crisis.

Over 40 million Americans were seeking unemployment benefits at the peak of the economic repercussions of the COVID-19 pandemic. Unfortunately, low-income, rural, and minority communities disproportionately experienced this economic shock. Given the relationship between wealth and health, successfully achieving equity post-COVID-19 will require deeper financial investments in underserved communities.⁹ Healthcare organizations, which represent 18% of the United States gross domestic product and employ nearly 9% of all working individuals, are uniquely positioned to have a direct influence on this strategy.

One equity-based strategy is for healthcare institutions to pursue an anchor mission. Anchor missions have increased a health system’s investment in social services, including providing housing and food resources.¹⁰ Additionally, hospitals such as Brigham and Women’s, Boston Children’s Hospital, and Bon Secours Health System, are working with a diverse group of entrepreneurs to create jobs and build wealth in underserved communities by employing local and minority-owned businesses to support critical supply chain purchasing decisions regarding food, maintenance, and construction projects.¹¹ These local and inclusive hiring and procurement measures can be bolstered by continued place-based investments by all health system leaders in vulnerable communities.

Since the first enslaved Africans were brought to America over 400 years ago, racial and ethnic minorities have experienced struggle and triumph, sadness and joy. The bonds of a long legacy of discrimination are so deep that we must be intentional in our pursuit of equity—during and beyond the COVID-19 pandemic. Placing equity at the center of healthcare system practice and policy implementation, fostering community resilience and emergency preparedness, and prioritizing equity in economic strategic planning are key steps toward addressing the population-level inequities exposed by the COVID-19 pandemic. As the once touted “great equalizer” rages on, we must remember that we are all jointly affected by the distress caused by the novel coronavirus and we also must be more aware than ever of our interconnectedness. We can use this time of pandemic to fight more than ever to ensure that all populations can enjoy just and optimal health.

The authors would like to thank Dr Denise Polit for her review of this manuscript.

Our knowledge of how natural catastrophes affect vulnerable populations should have helped us anticipate how coronavirus disease 2019 (COVID-19) would strike the United States. This disaster has followed the well-heeled path of its predecessors, predictably bending to the influence of social determinants of health,¹ structural inequality, and limited access to healthcare. Communities of color were hit early, hit hard,² and yet again, became our nation’s canary in the coal mine. Hospitals across the country have had a front seat to this novel coronavirus’ disproportionate effect across the diverse communities we serve. Several of the cities and neighborhoods adjacent to our hospital are home to the area’s highest density of limited English proficient (LEP), immigrant, Spanish-speaking individuals.^3,4 Our neighbors in these areas are more likely to have lower socioeconomic status, live in crowded housing, work in service industries deemed to be essential, and depend on shared and mass transit to get to work.^5,6 As became clear, many in these communities could not work from home, get groceries delivered, or adequately social distance; these were pandemic luxuries afforded to other, more affluent areas.⁷

In the weeks between March 25, 2020, and April 13, 2020, the Massachusetts General Hospital in Boston entered a COVID-19 surge now familiar to hospitals across the world. Like our peer institutions, we made broad and creative structural changes to inpatient services to meet the surge and we followed the numbers with anticipation. Over that 2-week period, we indeed saw the COVID-19–positive inpatient population swell as we had feared. However, with each page from the Emergency Department a disturbing trend was borne out:

ADMIT: 53-year-old Spanish-speaker with tachypnea.

ADMIT: 57-year-old factory worker, Spanish-speaking, sick for 10 days, intubated in the ED.

ADMIT: 58-year-old bodega employee, Spanish-speaking, febrile and breathless.

It buzzed across the medical floors and intensive care units: “What is going on in our Spanish speaking neighborhoods?” In fact, our shared anecdotal view was soon confirmed by admission statistics. Over the interval that our total COVID-19 census alarmingly rose sevenfold, the LEP Spanish-speaking census traced a striking curve, increasing nearly 20 times, to constitute over 40% of all COVID-19 patients (Figure). These communities were bearing a disproportionate share of the local burden of the pandemic.

COVID-19 created unique challenges to our interpreter services. The overwhelming number of LEP Spanish-speaking patients made it difficult for our existing interpreter staff to provide in-person translation. Virtual interpreter services were always available; however, using telephone interpretation in full personal protective equipment with patients who were already isolated and dealing with a scary diagnosis did not feel adequate to the need. In response to what we were seeing, on April 13, 2020, the idea emerged from the Chief Equity and Inclusion Officer, a native Spanish speaker, to assemble a team of native Spanish-speaking doctors, deploying them to assist in the clinical care of those LEP Spanish-speaking patients admitted with COVID-19. Out of this idea grew a creative and novel care delivery model, fashioned to prioritize culturally and linguistically competent care. It was deployed a few days later as the Spanish Language Care Group (SLCG). The belief was that this group’s members were uniquely equipped to work directly with existing frontline teams on the floors, intensive care units and the emergency department. As doctors, they were able to act as extensions of those teams, independently carrying out patient-facing clinical tasks, in Spanish, on an ad hoc basis. They took on history taking, procedural consents, clinical updates, discharge instructions, serious illness conversations and family meetings. They comforted and educated the frightened, connected with families, and unearthed relevant patient history that would have otherwise gone unnoticed. In many cases the SLCG member was the main figure communicating with patients as their clinical status deteriorated, as they were intubated, as they faced their worst fears about COVID-19.

At the time the group was assembled, each SLCG physician was verified as Qualified Bilingual Staff, already clinically credentialled at the hospital, and ready to volunteer to meet the need on the medicine COVID surge services. They practiced in virtually every division and department, including Anesthesia, Cardiology, Dermatology, Emergency Medicine, Gastroenterology, General Medicine, Neurology, Pediatrics, Psychiatry, and Radiology. With the assistance of leadership in Hospital Medicine, this team was rapidly deployed to inpatient teams to assist with the clinical care of COVID-19 patients. In total, 51 physicians—representing 14 countries of origin—participated in the effort, and their titles ranged from intern to full professor. Fourteen of them were formally deployed in the COVID surge context with approval of their departmental and divisional leadership. With such a robust response and institutional support, the SLCG was able to provide 24-hour coverage in support of the Medicine teams. During the peak of this hospital’s COVID surge, seven SLCG members were deployed daily 7 am to 7 pm, and four from 7 pm to 7 am.

For those patients in their most vulnerable moments, the impact of the SLCG’s work is hard to overestimate, and it has also been measured by overwhelmingly positive feedback from surge care teams: “The quality of care we provided today would have been impossible without [the SLCG]. I’m so grateful and was nearly moved to tears realizing how stunted our relationships with these patients have been due to language barrier.” Another team said that the SLCG doctor was able to “care for the patient in the same way I would have if I could speak Spanish” and “it is like day and night.”After the spring 2020 surge of COVID-19, procedural work resumed, so the SLCG doctors—many of whose usual clinical activity was suspended by the pandemic—returned to their proper perch on the organization chart. But as they reflect on their experience with the group, they report that it stirred a strong and very personal sense of purpose and vocation. Should a subsequent surge of COVID-19 occur, they are committed to building on the foundation that they have laid.

For hospitals that may consider deploying a team such as the SLCG, we can offer a number of concrete actions and policy recommendations. First, in preparation for the COVID surge we identified hospital clinicians with multilingual skills through the deployment of a multilingual registry. Such a registry is critical to understanding which clinicians among existing staff have these skills and who can be approached to join the team. Second, the inpatient medicine surge leadership team at our hospital, immediately recognizing the importance of this effort, developed a staffing strategy to integrate the SLCG into the institutional surge response. The benefit that the team offers needs to be made clear to those at the highest levels of operations and planning. Third, a strong and well-established Center for Diversity and Inclusion, and its leadership, helped facilitate our group’s staffing and organization. For hospitals looking to embrace the strength that their diversity-oriented recruitment efforts have afforded them, we recommend creating a centralized space in which professional relationships can grow and deepen, diverse perspectives can be explored, and embedded cultural and language skills can be championed.

The US healthcare system has much to learn from this phase of the COVID-19 era. Our experience with the Spanish Language Care Group has highlighted the value of language-concordant care, the power of cultural and linguistic competency, and the resiliency that diversity brings to a hospital’s professional staff. Our urgent response to COVID-19 has unroofed a long-simmering challenge: the detriment to care that arises when language becomes an obstacle. We are bringing a new focus to this issue and learning to view it through an equity lens. This is lending new energy to an ongoing conversation about how this hospital thinks about diversity, equity, and healthcare access in these pandemic times and into the hoped-for beyond.

The authors wish to express their profound gratitude to the members of the Spanish Language Care Group who brought such humanity and professionalism to the care of our patients during a uniquely vulnerable time.

Our knowledge of how natural catastrophes affect vulnerable populations should have helped us anticipate how coronavirus disease 2019 (COVID-19) would strike the United States. This disaster has followed the well-heeled path of its predecessors, predictably bending to the influence of social determinants of health,¹ structural inequality, and limited access to healthcare. Communities of color were hit early, hit hard,² and yet again, became our nation’s canary in the coal mine. Hospitals across the country have had a front seat to this novel coronavirus’ disproportionate effect across the diverse communities we serve. Several of the cities and neighborhoods adjacent to our hospital are home to the area’s highest density of limited English proficient (LEP), immigrant, Spanish-speaking individuals.^3,4 Our neighbors in these areas are more likely to have lower socioeconomic status, live in crowded housing, work in service industries deemed to be essential, and depend on shared and mass transit to get to work.^5,6 As became clear, many in these communities could not work from home, get groceries delivered, or adequately social distance; these were pandemic luxuries afforded to other, more affluent areas.⁷

In the weeks between March 25, 2020, and April 13, 2020, the Massachusetts General Hospital in Boston entered a COVID-19 surge now familiar to hospitals across the world. Like our peer institutions, we made broad and creative structural changes to inpatient services to meet the surge and we followed the numbers with anticipation. Over that 2-week period, we indeed saw the COVID-19–positive inpatient population swell as we had feared. However, with each page from the Emergency Department a disturbing trend was borne out:

ADMIT: 53-year-old Spanish-speaker with tachypnea.

ADMIT: 57-year-old factory worker, Spanish-speaking, sick for 10 days, intubated in the ED.

ADMIT: 58-year-old bodega employee, Spanish-speaking, febrile and breathless.

It buzzed across the medical floors and intensive care units: “What is going on in our Spanish speaking neighborhoods?” In fact, our shared anecdotal view was soon confirmed by admission statistics. Over the interval that our total COVID-19 census alarmingly rose sevenfold, the LEP Spanish-speaking census traced a striking curve, increasing nearly 20 times, to constitute over 40% of all COVID-19 patients (Figure). These communities were bearing a disproportionate share of the local burden of the pandemic.

COVID-19 created unique challenges to our interpreter services. The overwhelming number of LEP Spanish-speaking patients made it difficult for our existing interpreter staff to provide in-person translation. Virtual interpreter services were always available; however, using telephone interpretation in full personal protective equipment with patients who were already isolated and dealing with a scary diagnosis did not feel adequate to the need. In response to what we were seeing, on April 13, 2020, the idea emerged from the Chief Equity and Inclusion Officer, a native Spanish speaker, to assemble a team of native Spanish-speaking doctors, deploying them to assist in the clinical care of those LEP Spanish-speaking patients admitted with COVID-19. Out of this idea grew a creative and novel care delivery model, fashioned to prioritize culturally and linguistically competent care. It was deployed a few days later as the Spanish Language Care Group (SLCG). The belief was that this group’s members were uniquely equipped to work directly with existing frontline teams on the floors, intensive care units and the emergency department. As doctors, they were able to act as extensions of those teams, independently carrying out patient-facing clinical tasks, in Spanish, on an ad hoc basis. They took on history taking, procedural consents, clinical updates, discharge instructions, serious illness conversations and family meetings. They comforted and educated the frightened, connected with families, and unearthed relevant patient history that would have otherwise gone unnoticed. In many cases the SLCG member was the main figure communicating with patients as their clinical status deteriorated, as they were intubated, as they faced their worst fears about COVID-19.

At the time the group was assembled, each SLCG physician was verified as Qualified Bilingual Staff, already clinically credentialled at the hospital, and ready to volunteer to meet the need on the medicine COVID surge services. They practiced in virtually every division and department, including Anesthesia, Cardiology, Dermatology, Emergency Medicine, Gastroenterology, General Medicine, Neurology, Pediatrics, Psychiatry, and Radiology. With the assistance of leadership in Hospital Medicine, this team was rapidly deployed to inpatient teams to assist with the clinical care of COVID-19 patients. In total, 51 physicians—representing 14 countries of origin—participated in the effort, and their titles ranged from intern to full professor. Fourteen of them were formally deployed in the COVID surge context with approval of their departmental and divisional leadership. With such a robust response and institutional support, the SLCG was able to provide 24-hour coverage in support of the Medicine teams. During the peak of this hospital’s COVID surge, seven SLCG members were deployed daily 7 am to 7 pm, and four from 7 pm to 7 am.

For those patients in their most vulnerable moments, the impact of the SLCG’s work is hard to overestimate, and it has also been measured by overwhelmingly positive feedback from surge care teams: “The quality of care we provided today would have been impossible without [the SLCG]. I’m so grateful and was nearly moved to tears realizing how stunted our relationships with these patients have been due to language barrier.” Another team said that the SLCG doctor was able to “care for the patient in the same way I would have if I could speak Spanish” and “it is like day and night.”After the spring 2020 surge of COVID-19, procedural work resumed, so the SLCG doctors—many of whose usual clinical activity was suspended by the pandemic—returned to their proper perch on the organization chart. But as they reflect on their experience with the group, they report that it stirred a strong and very personal sense of purpose and vocation. Should a subsequent surge of COVID-19 occur, they are committed to building on the foundation that they have laid.

For hospitals that may consider deploying a team such as the SLCG, we can offer a number of concrete actions and policy recommendations. First, in preparation for the COVID surge we identified hospital clinicians with multilingual skills through the deployment of a multilingual registry. Such a registry is critical to understanding which clinicians among existing staff have these skills and who can be approached to join the team. Second, the inpatient medicine surge leadership team at our hospital, immediately recognizing the importance of this effort, developed a staffing strategy to integrate the SLCG into the institutional surge response. The benefit that the team offers needs to be made clear to those at the highest levels of operations and planning. Third, a strong and well-established Center for Diversity and Inclusion, and its leadership, helped facilitate our group’s staffing and organization. For hospitals looking to embrace the strength that their diversity-oriented recruitment efforts have afforded them, we recommend creating a centralized space in which professional relationships can grow and deepen, diverse perspectives can be explored, and embedded cultural and language skills can be championed.

The US healthcare system has much to learn from this phase of the COVID-19 era. Our experience with the Spanish Language Care Group has highlighted the value of language-concordant care, the power of cultural and linguistic competency, and the resiliency that diversity brings to a hospital’s professional staff. Our urgent response to COVID-19 has unroofed a long-simmering challenge: the detriment to care that arises when language becomes an obstacle. We are bringing a new focus to this issue and learning to view it through an equity lens. This is lending new energy to an ongoing conversation about how this hospital thinks about diversity, equity, and healthcare access in these pandemic times and into the hoped-for beyond.

The authors wish to express their profound gratitude to the members of the Spanish Language Care Group who brought such humanity and professionalism to the care of our patients during a uniquely vulnerable time.

Our knowledge of how natural catastrophes affect vulnerable populations should have helped us anticipate how coronavirus disease 2019 (COVID-19) would strike the United States. This disaster has followed the well-heeled path of its predecessors, predictably bending to the influence of social determinants of health,¹ structural inequality, and limited access to healthcare. Communities of color were hit early, hit hard,² and yet again, became our nation’s canary in the coal mine. Hospitals across the country have had a front seat to this novel coronavirus’ disproportionate effect across the diverse communities we serve. Several of the cities and neighborhoods adjacent to our hospital are home to the area’s highest density of limited English proficient (LEP), immigrant, Spanish-speaking individuals.^3,4 Our neighbors in these areas are more likely to have lower socioeconomic status, live in crowded housing, work in service industries deemed to be essential, and depend on shared and mass transit to get to work.^5,6 As became clear, many in these communities could not work from home, get groceries delivered, or adequately social distance; these were pandemic luxuries afforded to other, more affluent areas.⁷

In the weeks between March 25, 2020, and April 13, 2020, the Massachusetts General Hospital in Boston entered a COVID-19 surge now familiar to hospitals across the world. Like our peer institutions, we made broad and creative structural changes to inpatient services to meet the surge and we followed the numbers with anticipation. Over that 2-week period, we indeed saw the COVID-19–positive inpatient population swell as we had feared. However, with each page from the Emergency Department a disturbing trend was borne out:

ADMIT: 53-year-old Spanish-speaker with tachypnea.

ADMIT: 57-year-old factory worker, Spanish-speaking, sick for 10 days, intubated in the ED.

ADMIT: 58-year-old bodega employee, Spanish-speaking, febrile and breathless.

It buzzed across the medical floors and intensive care units: “What is going on in our Spanish speaking neighborhoods?” In fact, our shared anecdotal view was soon confirmed by admission statistics. Over the interval that our total COVID-19 census alarmingly rose sevenfold, the LEP Spanish-speaking census traced a striking curve, increasing nearly 20 times, to constitute over 40% of all COVID-19 patients (Figure). These communities were bearing a disproportionate share of the local burden of the pandemic.

COVID-19 created unique challenges to our interpreter services. The overwhelming number of LEP Spanish-speaking patients made it difficult for our existing interpreter staff to provide in-person translation. Virtual interpreter services were always available; however, using telephone interpretation in full personal protective equipment with patients who were already isolated and dealing with a scary diagnosis did not feel adequate to the need. In response to what we were seeing, on April 13, 2020, the idea emerged from the Chief Equity and Inclusion Officer, a native Spanish speaker, to assemble a team of native Spanish-speaking doctors, deploying them to assist in the clinical care of those LEP Spanish-speaking patients admitted with COVID-19. Out of this idea grew a creative and novel care delivery model, fashioned to prioritize culturally and linguistically competent care. It was deployed a few days later as the Spanish Language Care Group (SLCG). The belief was that this group’s members were uniquely equipped to work directly with existing frontline teams on the floors, intensive care units and the emergency department. As doctors, they were able to act as extensions of those teams, independently carrying out patient-facing clinical tasks, in Spanish, on an ad hoc basis. They took on history taking, procedural consents, clinical updates, discharge instructions, serious illness conversations and family meetings. They comforted and educated the frightened, connected with families, and unearthed relevant patient history that would have otherwise gone unnoticed. In many cases the SLCG member was the main figure communicating with patients as their clinical status deteriorated, as they were intubated, as they faced their worst fears about COVID-19.

At the time the group was assembled, each SLCG physician was verified as Qualified Bilingual Staff, already clinically credentialled at the hospital, and ready to volunteer to meet the need on the medicine COVID surge services. They practiced in virtually every division and department, including Anesthesia, Cardiology, Dermatology, Emergency Medicine, Gastroenterology, General Medicine, Neurology, Pediatrics, Psychiatry, and Radiology. With the assistance of leadership in Hospital Medicine, this team was rapidly deployed to inpatient teams to assist with the clinical care of COVID-19 patients. In total, 51 physicians—representing 14 countries of origin—participated in the effort, and their titles ranged from intern to full professor. Fourteen of them were formally deployed in the COVID surge context with approval of their departmental and divisional leadership. With such a robust response and institutional support, the SLCG was able to provide 24-hour coverage in support of the Medicine teams. During the peak of this hospital’s COVID surge, seven SLCG members were deployed daily 7 am to 7 pm, and four from 7 pm to 7 am.

For those patients in their most vulnerable moments, the impact of the SLCG’s work is hard to overestimate, and it has also been measured by overwhelmingly positive feedback from surge care teams: “The quality of care we provided today would have been impossible without [the SLCG]. I’m so grateful and was nearly moved to tears realizing how stunted our relationships with these patients have been due to language barrier.” Another team said that the SLCG doctor was able to “care for the patient in the same way I would have if I could speak Spanish” and “it is like day and night.”After the spring 2020 surge of COVID-19, procedural work resumed, so the SLCG doctors—many of whose usual clinical activity was suspended by the pandemic—returned to their proper perch on the organization chart. But as they reflect on their experience with the group, they report that it stirred a strong and very personal sense of purpose and vocation. Should a subsequent surge of COVID-19 occur, they are committed to building on the foundation that they have laid.

For hospitals that may consider deploying a team such as the SLCG, we can offer a number of concrete actions and policy recommendations. First, in preparation for the COVID surge we identified hospital clinicians with multilingual skills through the deployment of a multilingual registry. Such a registry is critical to understanding which clinicians among existing staff have these skills and who can be approached to join the team. Second, the inpatient medicine surge leadership team at our hospital, immediately recognizing the importance of this effort, developed a staffing strategy to integrate the SLCG into the institutional surge response. The benefit that the team offers needs to be made clear to those at the highest levels of operations and planning. Third, a strong and well-established Center for Diversity and Inclusion, and its leadership, helped facilitate our group’s staffing and organization. For hospitals looking to embrace the strength that their diversity-oriented recruitment efforts have afforded them, we recommend creating a centralized space in which professional relationships can grow and deepen, diverse perspectives can be explored, and embedded cultural and language skills can be championed.

The US healthcare system has much to learn from this phase of the COVID-19 era. Our experience with the Spanish Language Care Group has highlighted the value of language-concordant care, the power of cultural and linguistic competency, and the resiliency that diversity brings to a hospital’s professional staff. Our urgent response to COVID-19 has unroofed a long-simmering challenge: the detriment to care that arises when language becomes an obstacle. We are bringing a new focus to this issue and learning to view it through an equity lens. This is lending new energy to an ongoing conversation about how this hospital thinks about diversity, equity, and healthcare access in these pandemic times and into the hoped-for beyond.

The authors wish to express their profound gratitude to the members of the Spanish Language Care Group who brought such humanity and professionalism to the care of our patients during a uniquely vulnerable time.

The coronavirus disease 2019 (COVID-19) pandemic highlights long-standing inequities in health along racial/ethnic lines in the United States. Black, Hispanic, and Indigenous people have been disproportionately affected during the pandemic. For example, the age-adjusted mortality rate among Black people with COVID-19 is 3.4 times as high as that of White people.¹

Structural racism shapes social forces, institutions, and ideologies that generate and reinforce racial inequities across different aspects of life. In this perspective, we discuss how, in the COVID-19 context, structural racism shapes access to and quality of care, as well as socioeconomic and health status. We offer guidance to health systems and healthcare providers on addressing health inequities.

Disparities in access to and quality of care contribute to racial health disparities. At the onset of the COVID-19 pandemic in the United States, guidelines for COVID-19 testing were restrictive, only investigating those who had symptoms and had recently traveled to Wuhan, China, or had contact with someone who may have had the virus.² News reports show disparities in access to testing, with testing sites favoring wealthier, Whiter communities, a feature of racial residential segregation.³ Residential segregation has also contributed to a concentration of closures among urban public hospitals, affecting access to care.⁴ In New York City (NYC) and Boston, early hotspots of the pandemic, Black and Hispanic patients and underinsured/uninsured patients were significantly less likely to access care from academic medical centers (AMCs) compared with White, privately insured patients.⁵ AMCs boast greater resources, and inequalities produced by this segregated system of care are often exacerbated by governmental allocation of resources. For instance, NYC’s public hospitals care for the city’s low-income residents (who are disproportionately insured by Medicaid), yet received far less federal aid from the Provider Relief Fund COVID-19 High Impact Payments, which favored larger, private hospitals in Manhattan. These public hospitals, however, face looming Medicaid cuts.⁶ Similarly, the federal government delayed the release of funds to health centers located on Native American reservations, adversely affecting the Indian Health Service’s preparedness to face the pandemic.⁷ In tandem with the effects of residential segregation, these data highlight the tiered nature of the US healthcare system, a structure that significantly impacts the quality of care patients receive along racial and socioeconomic lines. Furthermore, studies have documented racial disparities in the provision of advanced therapies: in the case of predicting algorithms that identify patients with complex illnesses, reliance on cost (thus, previous utilization data) rather than actual illness means that only 17.5% of Black patients receive additional help.⁸

Healthcare alone does not explain the observed disparities. The disproportionately high risk of contracting the SARS-CoV-2 virus among Black, Hispanic and Indigenous people can be explained by factors that render physical distancing a luxury. First, in terms of occupational hazards, only 1 in 5 Black and 1 in 6 Hispanic workers can work remotely compared with 1 in 3 White workers. Additionally, Black and Hispanic workers are more likely to have jobs classified as critical in industries such as food retail, hospitality, and public transit. In NYC, Metropolitan Transportation Authority (MTA) employees reported using their own masks and home disinfectant at work, only to be reprimanded. By April 8, 2020, at least 41 MTA workers had died of COVID-19, and more than 6,000 were ill or self-quarantining, resulting in a transit crisis with increasingly long wait times and crowded subway platforms.⁹ Jason Hargrove, a Black bus driver in Detroit, shared a video underscoring the dangers of his work in which he says, “We’re out here as public workers, doing our job…but for you to get on the bus and stand on the bus, and cough several times without covering up your mouth . . . in the middle of a pandemic…some folks don’t care.” He died of COVID-19 complications 11 days after sharing his video.¹⁰ Such conditions likely also increased riders’ risk of contracting COVID-19. And while in aggregate, essential workers in healthcare receive more personal protective equipment (PPE) than those in other occupations, within NYC hospitals, the rationing of PPE was such that low-wage, nonmedical workers (79% of whom are Black or Hispanic) were given less PPE or none at all compared with nurses and physicians.¹¹

Beyond occupational hazards, Black and Hispanic people are more likely to live in multigenerational homes, an identified risk factor of COVID-19 infection.¹² Furthermore, Black and Hispanic people are overrepresented among homeless people as well as among those incarcerated. These social conditions, all products of structural racism, substantially and adversely affect the health status of Black, Hispanic, and Indigenous people, especially as it relates to comorbidities associated with higher COVID-19 mortality.

Black people are disproportionately represented among COVID-19 patients requiring hospitalization, consistent with more severe disease or delayed presentation. For instance, among a cohort of 3,626 patients in a health system in Louisiana, 76.9% of COVID-19 patients hospitalized and 70.6% of those who died were Black, even though Black people comprise only 31% of this health system’s patient population.¹³ Conditions associated with COVID-19 mortality include heart failure, obesity, and chronic obstructive pulmonary disease. Black, Hispanic, and Indigenous people have higher rates of these chronic illnesses,¹⁴ increasing COVID-19 mortality risk. The increased prevalence of these illnesses is attributable to the aforementioned social conditions and environmental factors and to the additional stress associated with repeated exposure to discrimination.¹⁵

Although the disparities highlighted during the pandemic are staggering, this moment can serve as a portal to reimagine a more equitable healthcare system. Health systems and providers should (1) remain vigilant in addressing bias and its effects on patient care; (2) implement strategies to mitigate structural bias and use data to rapidly mitigate disparities in quality of care and transitions in care; and (3) address inequities, diversity, and inclusion across the entire healthcare workforce.

Addressing Provider Bias

At the patient care level, healthcare providers have a role in ensuring patients have positive experiences with the healthcare system; this is an opportunity to address medical distrust. Providers should recognize the burden of psychosocial stress and place-based risk that contributes to patients’ presentations and clinical courses. In patient encounters, this awareness should translate to action, acknowledging patients’ experiences and individuality and upholding their dignity. Under conditions of burnout, physicians’ biases are more likely to manifest in patient encounters,¹⁶ and although stress and burnout among providers are likely at an all-time high during the COVID-19 pandemic, patients of color must not suffer disproportionately.

Addressing Structural Bias in Care Provision

Health systems should establish checklist-based protocols in order to mitigate the impact of bias on patient care, such as on referrals for advanced therapies. Algorithms used to automate certain aspects of care should not be biased against Black, Hispanic, and Indigenous patients, as has been the case with algorithms that lead to Black patients receiving lower levels of care compared with White patients with similar clinical presentations.⁸ Health systems should therefore systematically collect racial and sociodemographic data and implement rapid-cycle evaluation of processes and outcomes to root out biases. In tracking their own performance in providing equitable care, health systems should create feedback systems that inform individual providers of their practices for improvement, and individual departments should hold frequent “morbidity and mortality” style reviews of practices and outcomes to continuously improve. Additionally, collaborations with and financial support of community-based organizations to ensure safe transitions of care and to contribute to addressing patients’ unmet social needs should become the norm. This is particularly relevant for COVID-19 survivors who may face long-term chronic physical and mental sequelae such as post–intensive care syndrome and require multidisciplinary care.¹⁷

Workforce Equity, Diversity, and Inclusion

Health systems should also examine and address the ways in which they contribute to racial health inequities beyond healthcare provision. Among healthcare organizations, hospitals employ the majority of low-wage healthcare workers, most of them Black or Hispanic women. Nearly half of Black and Hispanic female healthcare workers earn less than $15 hourly (cited as a living wage, which could help prevent a significant number of premature deaths),¹⁸ and a quarter are uninsured or on Medicaid. Raising the hourly minimum wage to at least $15 would reduce poverty among female healthcare workers by 27.1%.¹⁹ Mortality decreases as income increases, and the lowest-income healthcare workers have a nearly six-fold higher risk of death relative to their highest-earning counterparts, a gradient steeper compared with other fields.²⁰ Health systems should guarantee occupational safety and adequate wages and benefits and provide employees with career-advancing opportunities that would facilitate upward mobility.

In addition to the aforementioned structural inequities embedded within the healthcare infrastructure, low-wage Black healthcare workers report experiencing interpersonal discrimination at work, such as being assigned more tasks compared with their White peers and having others higher up the hierarchy, such as supervisors, nurses, and physicians, assume they are incompetent. Workplace discrimination spans the organizational hierarchy. Black nurses and physicians report both interpersonal and organizational discrimination from patients and other healthcare workers and in terms of barriers to opportunities through hiring and credentialing processes.²¹ Black physicians are at greater risk of burnout and attrition, which is partly attributable to experiencing discrimination.^22,23

To address these experiences, health systems should invest in creating a work climate that is inclusive and explicitly stands against racism and other forms of discrimination. The rise of the Black Lives Matter movement has contributed to improving people’s attitudes toward Black people over the past years,²⁴ whereas implicit bias trainings, commonly employed to improve diversity and inclusion, may unwittingly further entrench the denial of the impact of racism (by attributing it to implicit rather than explicit attitudes)²⁵ or heighten intergroup racial anxiety and reduce individuals’ intentions to engage in intergroup contact.²⁶ Moreover, evidence shows interracial contact in medical school yields more positive explicit and implicit attitudes toward Black people among non–Black medical trainees, whereas bias trainings do not,²⁷ and a positive racial climate in medical school yields a greater interest in serving underserved and minority populations among non–Black medical trainees.²⁸ In other words, fostering a culture and structure that champions racial justice and diversifying the healthcare workforce would synergistically improve non–Black healthcare workers’ attitudes toward Black people while also improving the working conditions of Black healthcare workers and the experiences of Black patients. Healthcare is the fastest growing industry in the United States, and such initiatives would likely have a tremendous impact on moving the needle toward health equity.

The COVID-19 disparities were predictable. This pandemic may not end any time soon and certainly will not be the last we experience. Therefore, healthcare workers and health systems should recognize the societal barriers patients and workers face and implement strategies to eliminate biased practices in the provision of healthcare as well as through the compensation structure and workplace protection of healthcare workers, especially when the healthcare system experiences undue stress.

The coronavirus disease 2019 (COVID-19) pandemic highlights long-standing inequities in health along racial/ethnic lines in the United States. Black, Hispanic, and Indigenous people have been disproportionately affected during the pandemic. For example, the age-adjusted mortality rate among Black people with COVID-19 is 3.4 times as high as that of White people.¹

Structural racism shapes social forces, institutions, and ideologies that generate and reinforce racial inequities across different aspects of life. In this perspective, we discuss how, in the COVID-19 context, structural racism shapes access to and quality of care, as well as socioeconomic and health status. We offer guidance to health systems and healthcare providers on addressing health inequities.

Disparities in access to and quality of care contribute to racial health disparities. At the onset of the COVID-19 pandemic in the United States, guidelines for COVID-19 testing were restrictive, only investigating those who had symptoms and had recently traveled to Wuhan, China, or had contact with someone who may have had the virus.² News reports show disparities in access to testing, with testing sites favoring wealthier, Whiter communities, a feature of racial residential segregation.³ Residential segregation has also contributed to a concentration of closures among urban public hospitals, affecting access to care.⁴ In New York City (NYC) and Boston, early hotspots of the pandemic, Black and Hispanic patients and underinsured/uninsured patients were significantly less likely to access care from academic medical centers (AMCs) compared with White, privately insured patients.⁵ AMCs boast greater resources, and inequalities produced by this segregated system of care are often exacerbated by governmental allocation of resources. For instance, NYC’s public hospitals care for the city’s low-income residents (who are disproportionately insured by Medicaid), yet received far less federal aid from the Provider Relief Fund COVID-19 High Impact Payments, which favored larger, private hospitals in Manhattan. These public hospitals, however, face looming Medicaid cuts.⁶ Similarly, the federal government delayed the release of funds to health centers located on Native American reservations, adversely affecting the Indian Health Service’s preparedness to face the pandemic.⁷ In tandem with the effects of residential segregation, these data highlight the tiered nature of the US healthcare system, a structure that significantly impacts the quality of care patients receive along racial and socioeconomic lines. Furthermore, studies have documented racial disparities in the provision of advanced therapies: in the case of predicting algorithms that identify patients with complex illnesses, reliance on cost (thus, previous utilization data) rather than actual illness means that only 17.5% of Black patients receive additional help.⁸

Healthcare alone does not explain the observed disparities. The disproportionately high risk of contracting the SARS-CoV-2 virus among Black, Hispanic and Indigenous people can be explained by factors that render physical distancing a luxury. First, in terms of occupational hazards, only 1 in 5 Black and 1 in 6 Hispanic workers can work remotely compared with 1 in 3 White workers. Additionally, Black and Hispanic workers are more likely to have jobs classified as critical in industries such as food retail, hospitality, and public transit. In NYC, Metropolitan Transportation Authority (MTA) employees reported using their own masks and home disinfectant at work, only to be reprimanded. By April 8, 2020, at least 41 MTA workers had died of COVID-19, and more than 6,000 were ill or self-quarantining, resulting in a transit crisis with increasingly long wait times and crowded subway platforms.⁹ Jason Hargrove, a Black bus driver in Detroit, shared a video underscoring the dangers of his work in which he says, “We’re out here as public workers, doing our job…but for you to get on the bus and stand on the bus, and cough several times without covering up your mouth . . . in the middle of a pandemic…some folks don’t care.” He died of COVID-19 complications 11 days after sharing his video.¹⁰ Such conditions likely also increased riders’ risk of contracting COVID-19. And while in aggregate, essential workers in healthcare receive more personal protective equipment (PPE) than those in other occupations, within NYC hospitals, the rationing of PPE was such that low-wage, nonmedical workers (79% of whom are Black or Hispanic) were given less PPE or none at all compared with nurses and physicians.¹¹

Beyond occupational hazards, Black and Hispanic people are more likely to live in multigenerational homes, an identified risk factor of COVID-19 infection.¹² Furthermore, Black and Hispanic people are overrepresented among homeless people as well as among those incarcerated. These social conditions, all products of structural racism, substantially and adversely affect the health status of Black, Hispanic, and Indigenous people, especially as it relates to comorbidities associated with higher COVID-19 mortality.

Black people are disproportionately represented among COVID-19 patients requiring hospitalization, consistent with more severe disease or delayed presentation. For instance, among a cohort of 3,626 patients in a health system in Louisiana, 76.9% of COVID-19 patients hospitalized and 70.6% of those who died were Black, even though Black people comprise only 31% of this health system’s patient population.¹³ Conditions associated with COVID-19 mortality include heart failure, obesity, and chronic obstructive pulmonary disease. Black, Hispanic, and Indigenous people have higher rates of these chronic illnesses,¹⁴ increasing COVID-19 mortality risk. The increased prevalence of these illnesses is attributable to the aforementioned social conditions and environmental factors and to the additional stress associated with repeated exposure to discrimination.¹⁵

Although the disparities highlighted during the pandemic are staggering, this moment can serve as a portal to reimagine a more equitable healthcare system. Health systems and providers should (1) remain vigilant in addressing bias and its effects on patient care; (2) implement strategies to mitigate structural bias and use data to rapidly mitigate disparities in quality of care and transitions in care; and (3) address inequities, diversity, and inclusion across the entire healthcare workforce.

Addressing Provider Bias

At the patient care level, healthcare providers have a role in ensuring patients have positive experiences with the healthcare system; this is an opportunity to address medical distrust. Providers should recognize the burden of psychosocial stress and place-based risk that contributes to patients’ presentations and clinical courses. In patient encounters, this awareness should translate to action, acknowledging patients’ experiences and individuality and upholding their dignity. Under conditions of burnout, physicians’ biases are more likely to manifest in patient encounters,¹⁶ and although stress and burnout among providers are likely at an all-time high during the COVID-19 pandemic, patients of color must not suffer disproportionately.

Addressing Structural Bias in Care Provision

Health systems should establish checklist-based protocols in order to mitigate the impact of bias on patient care, such as on referrals for advanced therapies. Algorithms used to automate certain aspects of care should not be biased against Black, Hispanic, and Indigenous patients, as has been the case with algorithms that lead to Black patients receiving lower levels of care compared with White patients with similar clinical presentations.⁸ Health systems should therefore systematically collect racial and sociodemographic data and implement rapid-cycle evaluation of processes and outcomes to root out biases. In tracking their own performance in providing equitable care, health systems should create feedback systems that inform individual providers of their practices for improvement, and individual departments should hold frequent “morbidity and mortality” style reviews of practices and outcomes to continuously improve. Additionally, collaborations with and financial support of community-based organizations to ensure safe transitions of care and to contribute to addressing patients’ unmet social needs should become the norm. This is particularly relevant for COVID-19 survivors who may face long-term chronic physical and mental sequelae such as post–intensive care syndrome and require multidisciplinary care.¹⁷

Workforce Equity, Diversity, and Inclusion

Health systems should also examine and address the ways in which they contribute to racial health inequities beyond healthcare provision. Among healthcare organizations, hospitals employ the majority of low-wage healthcare workers, most of them Black or Hispanic women. Nearly half of Black and Hispanic female healthcare workers earn less than $15 hourly (cited as a living wage, which could help prevent a significant number of premature deaths),¹⁸ and a quarter are uninsured or on Medicaid. Raising the hourly minimum wage to at least $15 would reduce poverty among female healthcare workers by 27.1%.¹⁹ Mortality decreases as income increases, and the lowest-income healthcare workers have a nearly six-fold higher risk of death relative to their highest-earning counterparts, a gradient steeper compared with other fields.²⁰ Health systems should guarantee occupational safety and adequate wages and benefits and provide employees with career-advancing opportunities that would facilitate upward mobility.

In addition to the aforementioned structural inequities embedded within the healthcare infrastructure, low-wage Black healthcare workers report experiencing interpersonal discrimination at work, such as being assigned more tasks compared with their White peers and having others higher up the hierarchy, such as supervisors, nurses, and physicians, assume they are incompetent. Workplace discrimination spans the organizational hierarchy. Black nurses and physicians report both interpersonal and organizational discrimination from patients and other healthcare workers and in terms of barriers to opportunities through hiring and credentialing processes.²¹ Black physicians are at greater risk of burnout and attrition, which is partly attributable to experiencing discrimination.^22,23

To address these experiences, health systems should invest in creating a work climate that is inclusive and explicitly stands against racism and other forms of discrimination. The rise of the Black Lives Matter movement has contributed to improving people’s attitudes toward Black people over the past years,²⁴ whereas implicit bias trainings, commonly employed to improve diversity and inclusion, may unwittingly further entrench the denial of the impact of racism (by attributing it to implicit rather than explicit attitudes)²⁵ or heighten intergroup racial anxiety and reduce individuals’ intentions to engage in intergroup contact.²⁶ Moreover, evidence shows interracial contact in medical school yields more positive explicit and implicit attitudes toward Black people among non–Black medical trainees, whereas bias trainings do not,²⁷ and a positive racial climate in medical school yields a greater interest in serving underserved and minority populations among non–Black medical trainees.²⁸ In other words, fostering a culture and structure that champions racial justice and diversifying the healthcare workforce would synergistically improve non–Black healthcare workers’ attitudes toward Black people while also improving the working conditions of Black healthcare workers and the experiences of Black patients. Healthcare is the fastest growing industry in the United States, and such initiatives would likely have a tremendous impact on moving the needle toward health equity.

The COVID-19 disparities were predictable. This pandemic may not end any time soon and certainly will not be the last we experience. Therefore, healthcare workers and health systems should recognize the societal barriers patients and workers face and implement strategies to eliminate biased practices in the provision of healthcare as well as through the compensation structure and workplace protection of healthcare workers, especially when the healthcare system experiences undue stress.

The coronavirus disease 2019 (COVID-19) pandemic highlights long-standing inequities in health along racial/ethnic lines in the United States. Black, Hispanic, and Indigenous people have been disproportionately affected during the pandemic. For example, the age-adjusted mortality rate among Black people with COVID-19 is 3.4 times as high as that of White people.¹

Structural racism shapes social forces, institutions, and ideologies that generate and reinforce racial inequities across different aspects of life. In this perspective, we discuss how, in the COVID-19 context, structural racism shapes access to and quality of care, as well as socioeconomic and health status. We offer guidance to health systems and healthcare providers on addressing health inequities.

Disparities in access to and quality of care contribute to racial health disparities. At the onset of the COVID-19 pandemic in the United States, guidelines for COVID-19 testing were restrictive, only investigating those who had symptoms and had recently traveled to Wuhan, China, or had contact with someone who may have had the virus.² News reports show disparities in access to testing, with testing sites favoring wealthier, Whiter communities, a feature of racial residential segregation.³ Residential segregation has also contributed to a concentration of closures among urban public hospitals, affecting access to care.⁴ In New York City (NYC) and Boston, early hotspots of the pandemic, Black and Hispanic patients and underinsured/uninsured patients were significantly less likely to access care from academic medical centers (AMCs) compared with White, privately insured patients.⁵ AMCs boast greater resources, and inequalities produced by this segregated system of care are often exacerbated by governmental allocation of resources. For instance, NYC’s public hospitals care for the city’s low-income residents (who are disproportionately insured by Medicaid), yet received far less federal aid from the Provider Relief Fund COVID-19 High Impact Payments, which favored larger, private hospitals in Manhattan. These public hospitals, however, face looming Medicaid cuts.⁶ Similarly, the federal government delayed the release of funds to health centers located on Native American reservations, adversely affecting the Indian Health Service’s preparedness to face the pandemic.⁷ In tandem with the effects of residential segregation, these data highlight the tiered nature of the US healthcare system, a structure that significantly impacts the quality of care patients receive along racial and socioeconomic lines. Furthermore, studies have documented racial disparities in the provision of advanced therapies: in the case of predicting algorithms that identify patients with complex illnesses, reliance on cost (thus, previous utilization data) rather than actual illness means that only 17.5% of Black patients receive additional help.⁸

Healthcare alone does not explain the observed disparities. The disproportionately high risk of contracting the SARS-CoV-2 virus among Black, Hispanic and Indigenous people can be explained by factors that render physical distancing a luxury. First, in terms of occupational hazards, only 1 in 5 Black and 1 in 6 Hispanic workers can work remotely compared with 1 in 3 White workers. Additionally, Black and Hispanic workers are more likely to have jobs classified as critical in industries such as food retail, hospitality, and public transit. In NYC, Metropolitan Transportation Authority (MTA) employees reported using their own masks and home disinfectant at work, only to be reprimanded. By April 8, 2020, at least 41 MTA workers had died of COVID-19, and more than 6,000 were ill or self-quarantining, resulting in a transit crisis with increasingly long wait times and crowded subway platforms.⁹ Jason Hargrove, a Black bus driver in Detroit, shared a video underscoring the dangers of his work in which he says, “We’re out here as public workers, doing our job…but for you to get on the bus and stand on the bus, and cough several times without covering up your mouth . . . in the middle of a pandemic…some folks don’t care.” He died of COVID-19 complications 11 days after sharing his video.¹⁰ Such conditions likely also increased riders’ risk of contracting COVID-19. And while in aggregate, essential workers in healthcare receive more personal protective equipment (PPE) than those in other occupations, within NYC hospitals, the rationing of PPE was such that low-wage, nonmedical workers (79% of whom are Black or Hispanic) were given less PPE or none at all compared with nurses and physicians.¹¹

Beyond occupational hazards, Black and Hispanic people are more likely to live in multigenerational homes, an identified risk factor of COVID-19 infection.¹² Furthermore, Black and Hispanic people are overrepresented among homeless people as well as among those incarcerated. These social conditions, all products of structural racism, substantially and adversely affect the health status of Black, Hispanic, and Indigenous people, especially as it relates to comorbidities associated with higher COVID-19 mortality.

Black people are disproportionately represented among COVID-19 patients requiring hospitalization, consistent with more severe disease or delayed presentation. For instance, among a cohort of 3,626 patients in a health system in Louisiana, 76.9% of COVID-19 patients hospitalized and 70.6% of those who died were Black, even though Black people comprise only 31% of this health system’s patient population.¹³ Conditions associated with COVID-19 mortality include heart failure, obesity, and chronic obstructive pulmonary disease. Black, Hispanic, and Indigenous people have higher rates of these chronic illnesses,¹⁴ increasing COVID-19 mortality risk. The increased prevalence of these illnesses is attributable to the aforementioned social conditions and environmental factors and to the additional stress associated with repeated exposure to discrimination.¹⁵

Although the disparities highlighted during the pandemic are staggering, this moment can serve as a portal to reimagine a more equitable healthcare system. Health systems and providers should (1) remain vigilant in addressing bias and its effects on patient care; (2) implement strategies to mitigate structural bias and use data to rapidly mitigate disparities in quality of care and transitions in care; and (3) address inequities, diversity, and inclusion across the entire healthcare workforce.

Addressing Provider Bias

At the patient care level, healthcare providers have a role in ensuring patients have positive experiences with the healthcare system; this is an opportunity to address medical distrust. Providers should recognize the burden of psychosocial stress and place-based risk that contributes to patients’ presentations and clinical courses. In patient encounters, this awareness should translate to action, acknowledging patients’ experiences and individuality and upholding their dignity. Under conditions of burnout, physicians’ biases are more likely to manifest in patient encounters,¹⁶ and although stress and burnout among providers are likely at an all-time high during the COVID-19 pandemic, patients of color must not suffer disproportionately.

Addressing Structural Bias in Care Provision

Health systems should establish checklist-based protocols in order to mitigate the impact of bias on patient care, such as on referrals for advanced therapies. Algorithms used to automate certain aspects of care should not be biased against Black, Hispanic, and Indigenous patients, as has been the case with algorithms that lead to Black patients receiving lower levels of care compared with White patients with similar clinical presentations.⁸ Health systems should therefore systematically collect racial and sociodemographic data and implement rapid-cycle evaluation of processes and outcomes to root out biases. In tracking their own performance in providing equitable care, health systems should create feedback systems that inform individual providers of their practices for improvement, and individual departments should hold frequent “morbidity and mortality” style reviews of practices and outcomes to continuously improve. Additionally, collaborations with and financial support of community-based organizations to ensure safe transitions of care and to contribute to addressing patients’ unmet social needs should become the norm. This is particularly relevant for COVID-19 survivors who may face long-term chronic physical and mental sequelae such as post–intensive care syndrome and require multidisciplinary care.¹⁷

Workforce Equity, Diversity, and Inclusion

Health systems should also examine and address the ways in which they contribute to racial health inequities beyond healthcare provision. Among healthcare organizations, hospitals employ the majority of low-wage healthcare workers, most of them Black or Hispanic women. Nearly half of Black and Hispanic female healthcare workers earn less than $15 hourly (cited as a living wage, which could help prevent a significant number of premature deaths),¹⁸ and a quarter are uninsured or on Medicaid. Raising the hourly minimum wage to at least $15 would reduce poverty among female healthcare workers by 27.1%.¹⁹ Mortality decreases as income increases, and the lowest-income healthcare workers have a nearly six-fold higher risk of death relative to their highest-earning counterparts, a gradient steeper compared with other fields.²⁰ Health systems should guarantee occupational safety and adequate wages and benefits and provide employees with career-advancing opportunities that would facilitate upward mobility.

In addition to the aforementioned structural inequities embedded within the healthcare infrastructure, low-wage Black healthcare workers report experiencing interpersonal discrimination at work, such as being assigned more tasks compared with their White peers and having others higher up the hierarchy, such as supervisors, nurses, and physicians, assume they are incompetent. Workplace discrimination spans the organizational hierarchy. Black nurses and physicians report both interpersonal and organizational discrimination from patients and other healthcare workers and in terms of barriers to opportunities through hiring and credentialing processes.²¹ Black physicians are at greater risk of burnout and attrition, which is partly attributable to experiencing discrimination.^22,23

To address these experiences, health systems should invest in creating a work climate that is inclusive and explicitly stands against racism and other forms of discrimination. The rise of the Black Lives Matter movement has contributed to improving people’s attitudes toward Black people over the past years,²⁴ whereas implicit bias trainings, commonly employed to improve diversity and inclusion, may unwittingly further entrench the denial of the impact of racism (by attributing it to implicit rather than explicit attitudes)²⁵ or heighten intergroup racial anxiety and reduce individuals’ intentions to engage in intergroup contact.²⁶ Moreover, evidence shows interracial contact in medical school yields more positive explicit and implicit attitudes toward Black people among non–Black medical trainees, whereas bias trainings do not,²⁷ and a positive racial climate in medical school yields a greater interest in serving underserved and minority populations among non–Black medical trainees.²⁸ In other words, fostering a culture and structure that champions racial justice and diversifying the healthcare workforce would synergistically improve non–Black healthcare workers’ attitudes toward Black people while also improving the working conditions of Black healthcare workers and the experiences of Black patients. Healthcare is the fastest growing industry in the United States, and such initiatives would likely have a tremendous impact on moving the needle toward health equity.

The COVID-19 disparities were predictable. This pandemic may not end any time soon and certainly will not be the last we experience. Therefore, healthcare workers and health systems should recognize the societal barriers patients and workers face and implement strategies to eliminate biased practices in the provision of healthcare as well as through the compensation structure and workplace protection of healthcare workers, especially when the healthcare system experiences undue stress.

Inspired by the ABIM Foundation’s Choosing Wisel y ^® campaign, the “Things We Do for No Reason ^™” (TWDFNR) series reviews practices that have become common parts of hospital care but may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent clear-cut conclusions or clinical practice standards but are meant as a starting place for research and active discussions among hospitalists and patients. We invite you to be part of that discussion.

A hospitalist admits a 68-year-old woman for community-acquired pneumonia with a past medical history of hypertension, gastroesophageal reflux disease, and osteoarthritis. Her hospitalist consults physical therapy to maximize mobility; continues her home medications including pantoprazole, hydrochlorothiazide, and acetaminophen; and initiates antimicrobial therapy with ceftriaxone and azithromycin. The hospital admission order set requires administration of subcutaneous unfractionated heparin for venous thromboembolism chemoprophylaxis.

Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), ranks among the leading preventable causes of morbidity and mortality in hospitalized patients.¹ DVTs can rapidly progress to a PE, which account for 5% to 10% of in-hospital deaths.¹ The negative sequelae of in-hospital VTE, including prolonged hospital stay, increased healthcare costs, and greater risks associated with pharmacologic treatment, add $9 to $18.2 billion in US healthcare expenditures each year.² Various risk-assessment models (RAMs) identify medical patients at high risk for developing VTE based on the presence of risk factors including acute heart failure, prior history of VTE, and reduced mobility.³ Since hospitalization may itself increase the risk for VTE, medical patients often receive universal chemoprophylaxis with anticoagulants such as unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), or fondaparinux.³ A meta-analysis of randomized controlled trials (RCTs) published by Wein et al supports the use of VTE chemoprophylaxis in high-risk patients.⁴ It showed statistically significant reductions in rates of PE in high-risk hospitalized medical patients with UFH (risk ratio [RR], 0.64; 95% CI, 0.50-0.82) or LMWH chemoprophylaxis (RR, 0.37; 95% CI, 0.21-0.64), compared with controls.

In recognition of the magnitude of the problem, national organizations have emphasized routine chemoprophylaxis for prevention of in-hospital VTE as a top-priority measure for patient safety.^5,6 The Joint Commission includes chemoprophylaxis as a quality core metric and failure to adhere to such standards compromises hospital accreditation.⁵ Since 2008, the Centers for Medicare & Medicaid Services no longer reimburses hospitals for preventable VTE and requires institutions to document the rationale for omitting chemoprophylaxis if not commenced on hospital admission.⁶

In order to understand why chemoprophylaxis fails to benefit low-risk medical patients, it is necessary to critically examine the benefits identified in trials of high-risk patients. Although RCTs and meta-analysis of chemoprophylaxis have consistently demonstrated a reduction in VTE, prevention of asymptomatic VTE identified on screening with ultrasound or venography accounts for more than 90% of the composite outcome in the three key trials.^7-9 Hospitalists do not routinely screen for asymptomatic VTE, and incorporation of these events into composite VTE outcomes inflates the magnitude of benefit gained by chemoprophylaxis. Importantly, the standard of care does not include screening for asymptomatic DVTs, and studies have estimated that only 10% to 15% of asymptomatic DVTs progress to a symptomatic VTE.¹⁰

A meta-analysis of trials evaluating unselected general medical patients (ie, not those with specific high-risk conditions such as acute myocardial infarction) did not show a reduction in symptomatic VTE with chemoprophylaxis (odds ratio [OR], 0.59; 95% CI, 0.29-1.23).¹¹ In the meta-analysis by Wein et al, which did include patients with specific high-risk conditions, chemoprophylaxis produced a small absolute risk reduction, resulting in a number needed to treat (NNT) of 345 to prevent one PE.⁴ This demonstrates that, even in high-risk patients, the magnitude of benefit is small. Population-level data also question the benefit of chemoprophylaxis. Flanders et al stratified 35 Michigan hospitals into high-, moderate-, and low-performance tertiles, with performance based on the rate of chemoprophylaxis use on admission for general medical patients at high-risk for VTE. The authors found no significant difference in the rate of VTE at 90 days among tertiles.¹² These findings question the usefulness of universal chemoprophylaxis when applied in a real-world setting.

The high rates of VTE in the absence of chemoprophylaxis reported in historic trials may overestimate the contemporary risk. A 2019 multicenter, observational study examined the rate of hospital-acquired DVT for 1,170 low- and high-risk patients with acute medical illness admitted to the internal medicine ward.¹³ Of them, 250 (21%) underwent prophylaxis with parenteral anticoagulants (mean Padua Prediction Score, 4.5). The remaining 920 (79%) were not treated with prophylaxis (mean Padua Prediction Score, 2.5). All patients underwent ultrasound at admission and discharge. The average length of stay was 13 days, and just three patients (0.3%) experienced in-hospital DVT, two of whom were receiving chemoprophylaxis. Only one (0.09%) DVT was symptomatic.

It should be emphasized that any evidence favoring chemoprophylaxis comes from studies of patients at high-risk of VTE. No data show benefit for low-risk patients. Therefore, any risk of chemoprophylaxis likely outweighs the benefits in low-risk patients. Importantly, the risks are underappreciated. A 2014 meta-analysis reported an increased risk of major hemorrhage (OR, 1.81; 95% CI, 1.10-2.98; P = .02) in high-risk medically ill patients on chemoprophylaxis.¹⁴ This results in a number needed to harm for major bleeding of 336, a value similar to the NNT for benefit reported by Wein et al.⁴ Heparin-induced thrombocytopenia, a potentially limb- and life-threatening complication of UFH or LMWH exposure, has an overall incidence of 0.3% to 0.7% in hospitalized patients on chemoprophylaxis.³ Finally, the most commonly used chemoprophylaxis medications are administered subcutaneously, resulting in injection site pain. Unsurprisingly, hospitalized patients refuse chemoprophylaxis more frequently than any other medication.¹⁵

The negative implications of inappropriate chemoprophylaxis extend beyond direct harms to patients. Poor stratification and overuse results in unnecessary healthcare costs. One single-center retrospective review demonstrated that, after integration of chemoprophylaxis into hospital order sets, 76% of patients received unnecessary administration of chemoprophylaxis, resulting in an annualized expenditure of $77,652.¹⁶ This does not take into account costs associated with major bleeds.

Unfortunately, the pendulum has shifted from an era of underprescribing chemoprophylaxis to hospitalized medical patients to one of overprescribing. Data published in 2018 suggest that providers overuse chemoprophylaxis in low-risk medical patients at more than double the rate of underusing it in high-risk patients (57% vs 21%).¹⁷

Several national societies, including the often cited American College of Chest Physicians (ACCP) and American Society of Hematology (ASH), provide guidance on the use of VTE chemoprophylaxis in acutely ill medical inpatients.^3,18 The ASH guidelines conditionally recommend VTE chemoprophylaxis rather than no chemoprophylaxis.¹⁸ However, the guidelines do not provide guidance on a risk-stratified approach and disclose that this recommendation is supported by a low certainty in the evidence of the net health benefit gained.¹⁸ Guidelines from ACCP lean towards individualized care and recommend against the use of VTE chemoprophylaxis for hospitalized acutely ill, low-risk medical patients.³

Clinicians should risk stratify using validated RAMs when making a patient-centered treatment plan on admission. The table outlines the most common RAMs with evidence for use in acute medically ill hospitalized patients. Although RAMs have limitations (eg, lack of prospective validation and complexity), the ACCP guidelines advocate for their use.³

Given that immobility independently increases risk for VTE, early mobilization is a simple and cost-effective way to potentially prevent VTE in low-risk patients. In addition to this potential benefit, early mobilization shortens the length of hospital stay, improves functional status and rates of delirium in hospitalized elderly patients, and hastens postoperative recovery after major surgeries.¹⁹

• Incorporate a patient-centered, risk-stratified approach to identify low-risk patients. This can be done manually or with use of RAMS embedded in the electronic health record.
• Do not prescribe chemoprophylaxis to low-risk hospitalized medical patients.
• Emphasize the importance of early mobilization in hospitalized patients.

In regard to the case, the hospitalist should use a RAM developed for the nonsurgical, non–critically ill patient to determine her need for chemoprophylaxis. Based on the clinical data presented, the three RAMs available would classify the patient as low risk for developing an in-hospital VTE. She should not receive chemoprophylaxis given the lack of data demonstrating benefit in this population. To mitigate the potential risk of bleeding, heparin-induced thrombocytopenia, and painful injections, the hospitalist should discontinue heparin. The hospitalist should advocate for early mobilization and minimize the duration of hospital stay as appropriate.

Do you think this is a low-value practice? Is this truly a “Thing We Do for No Reason^™”? Share what you do in your practice and join in the conversation online by retweeting it on Twitter (#TWDFNR) and liking it on Facebook. We invite you to propose ideas for other “Things We Do for No Reason^™” topics by emailing [email protected].

Inspired by the ABIM Foundation’s Choosing Wisel y ^® campaign, the “Things We Do for No Reason ^™” (TWDFNR) series reviews practices that have become common parts of hospital care but may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent clear-cut conclusions or clinical practice standards but are meant as a starting place for research and active discussions among hospitalists and patients. We invite you to be part of that discussion.

A hospitalist admits a 68-year-old woman for community-acquired pneumonia with a past medical history of hypertension, gastroesophageal reflux disease, and osteoarthritis. Her hospitalist consults physical therapy to maximize mobility; continues her home medications including pantoprazole, hydrochlorothiazide, and acetaminophen; and initiates antimicrobial therapy with ceftriaxone and azithromycin. The hospital admission order set requires administration of subcutaneous unfractionated heparin for venous thromboembolism chemoprophylaxis.

Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), ranks among the leading preventable causes of morbidity and mortality in hospitalized patients.¹ DVTs can rapidly progress to a PE, which account for 5% to 10% of in-hospital deaths.¹ The negative sequelae of in-hospital VTE, including prolonged hospital stay, increased healthcare costs, and greater risks associated with pharmacologic treatment, add $9 to $18.2 billion in US healthcare expenditures each year.² Various risk-assessment models (RAMs) identify medical patients at high risk for developing VTE based on the presence of risk factors including acute heart failure, prior history of VTE, and reduced mobility.³ Since hospitalization may itself increase the risk for VTE, medical patients often receive universal chemoprophylaxis with anticoagulants such as unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), or fondaparinux.³ A meta-analysis of randomized controlled trials (RCTs) published by Wein et al supports the use of VTE chemoprophylaxis in high-risk patients.⁴ It showed statistically significant reductions in rates of PE in high-risk hospitalized medical patients with UFH (risk ratio [RR], 0.64; 95% CI, 0.50-0.82) or LMWH chemoprophylaxis (RR, 0.37; 95% CI, 0.21-0.64), compared with controls.

In recognition of the magnitude of the problem, national organizations have emphasized routine chemoprophylaxis for prevention of in-hospital VTE as a top-priority measure for patient safety.^5,6 The Joint Commission includes chemoprophylaxis as a quality core metric and failure to adhere to such standards compromises hospital accreditation.⁵ Since 2008, the Centers for Medicare & Medicaid Services no longer reimburses hospitals for preventable VTE and requires institutions to document the rationale for omitting chemoprophylaxis if not commenced on hospital admission.⁶

In order to understand why chemoprophylaxis fails to benefit low-risk medical patients, it is necessary to critically examine the benefits identified in trials of high-risk patients. Although RCTs and meta-analysis of chemoprophylaxis have consistently demonstrated a reduction in VTE, prevention of asymptomatic VTE identified on screening with ultrasound or venography accounts for more than 90% of the composite outcome in the three key trials.^7-9 Hospitalists do not routinely screen for asymptomatic VTE, and incorporation of these events into composite VTE outcomes inflates the magnitude of benefit gained by chemoprophylaxis. Importantly, the standard of care does not include screening for asymptomatic DVTs, and studies have estimated that only 10% to 15% of asymptomatic DVTs progress to a symptomatic VTE.¹⁰

A meta-analysis of trials evaluating unselected general medical patients (ie, not those with specific high-risk conditions such as acute myocardial infarction) did not show a reduction in symptomatic VTE with chemoprophylaxis (odds ratio [OR], 0.59; 95% CI, 0.29-1.23).¹¹ In the meta-analysis by Wein et al, which did include patients with specific high-risk conditions, chemoprophylaxis produced a small absolute risk reduction, resulting in a number needed to treat (NNT) of 345 to prevent one PE.⁴ This demonstrates that, even in high-risk patients, the magnitude of benefit is small. Population-level data also question the benefit of chemoprophylaxis. Flanders et al stratified 35 Michigan hospitals into high-, moderate-, and low-performance tertiles, with performance based on the rate of chemoprophylaxis use on admission for general medical patients at high-risk for VTE. The authors found no significant difference in the rate of VTE at 90 days among tertiles.¹² These findings question the usefulness of universal chemoprophylaxis when applied in a real-world setting.

The high rates of VTE in the absence of chemoprophylaxis reported in historic trials may overestimate the contemporary risk. A 2019 multicenter, observational study examined the rate of hospital-acquired DVT for 1,170 low- and high-risk patients with acute medical illness admitted to the internal medicine ward.¹³ Of them, 250 (21%) underwent prophylaxis with parenteral anticoagulants (mean Padua Prediction Score, 4.5). The remaining 920 (79%) were not treated with prophylaxis (mean Padua Prediction Score, 2.5). All patients underwent ultrasound at admission and discharge. The average length of stay was 13 days, and just three patients (0.3%) experienced in-hospital DVT, two of whom were receiving chemoprophylaxis. Only one (0.09%) DVT was symptomatic.

It should be emphasized that any evidence favoring chemoprophylaxis comes from studies of patients at high-risk of VTE. No data show benefit for low-risk patients. Therefore, any risk of chemoprophylaxis likely outweighs the benefits in low-risk patients. Importantly, the risks are underappreciated. A 2014 meta-analysis reported an increased risk of major hemorrhage (OR, 1.81; 95% CI, 1.10-2.98; P = .02) in high-risk medically ill patients on chemoprophylaxis.¹⁴ This results in a number needed to harm for major bleeding of 336, a value similar to the NNT for benefit reported by Wein et al.⁴ Heparin-induced thrombocytopenia, a potentially limb- and life-threatening complication of UFH or LMWH exposure, has an overall incidence of 0.3% to 0.7% in hospitalized patients on chemoprophylaxis.³ Finally, the most commonly used chemoprophylaxis medications are administered subcutaneously, resulting in injection site pain. Unsurprisingly, hospitalized patients refuse chemoprophylaxis more frequently than any other medication.¹⁵

The negative implications of inappropriate chemoprophylaxis extend beyond direct harms to patients. Poor stratification and overuse results in unnecessary healthcare costs. One single-center retrospective review demonstrated that, after integration of chemoprophylaxis into hospital order sets, 76% of patients received unnecessary administration of chemoprophylaxis, resulting in an annualized expenditure of $77,652.¹⁶ This does not take into account costs associated with major bleeds.

Unfortunately, the pendulum has shifted from an era of underprescribing chemoprophylaxis to hospitalized medical patients to one of overprescribing. Data published in 2018 suggest that providers overuse chemoprophylaxis in low-risk medical patients at more than double the rate of underusing it in high-risk patients (57% vs 21%).¹⁷

Several national societies, including the often cited American College of Chest Physicians (ACCP) and American Society of Hematology (ASH), provide guidance on the use of VTE chemoprophylaxis in acutely ill medical inpatients.^3,18 The ASH guidelines conditionally recommend VTE chemoprophylaxis rather than no chemoprophylaxis.¹⁸ However, the guidelines do not provide guidance on a risk-stratified approach and disclose that this recommendation is supported by a low certainty in the evidence of the net health benefit gained.¹⁸ Guidelines from ACCP lean towards individualized care and recommend against the use of VTE chemoprophylaxis for hospitalized acutely ill, low-risk medical patients.³

Clinicians should risk stratify using validated RAMs when making a patient-centered treatment plan on admission. The table outlines the most common RAMs with evidence for use in acute medically ill hospitalized patients. Although RAMs have limitations (eg, lack of prospective validation and complexity), the ACCP guidelines advocate for their use.³

Given that immobility independently increases risk for VTE, early mobilization is a simple and cost-effective way to potentially prevent VTE in low-risk patients. In addition to this potential benefit, early mobilization shortens the length of hospital stay, improves functional status and rates of delirium in hospitalized elderly patients, and hastens postoperative recovery after major surgeries.¹⁹

• Incorporate a patient-centered, risk-stratified approach to identify low-risk patients. This can be done manually or with use of RAMS embedded in the electronic health record.
• Do not prescribe chemoprophylaxis to low-risk hospitalized medical patients.
• Emphasize the importance of early mobilization in hospitalized patients.

In regard to the case, the hospitalist should use a RAM developed for the nonsurgical, non–critically ill patient to determine her need for chemoprophylaxis. Based on the clinical data presented, the three RAMs available would classify the patient as low risk for developing an in-hospital VTE. She should not receive chemoprophylaxis given the lack of data demonstrating benefit in this population. To mitigate the potential risk of bleeding, heparin-induced thrombocytopenia, and painful injections, the hospitalist should discontinue heparin. The hospitalist should advocate for early mobilization and minimize the duration of hospital stay as appropriate.

Do you think this is a low-value practice? Is this truly a “Thing We Do for No Reason^™”? Share what you do in your practice and join in the conversation online by retweeting it on Twitter (#TWDFNR) and liking it on Facebook. We invite you to propose ideas for other “Things We Do for No Reason^™” topics by emailing [email protected].

Inspired by the ABIM Foundation’s Choosing Wisel y ^® campaign, the “Things We Do for No Reason ^™” (TWDFNR) series reviews practices that have become common parts of hospital care but may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent clear-cut conclusions or clinical practice standards but are meant as a starting place for research and active discussions among hospitalists and patients. We invite you to be part of that discussion.

A hospitalist admits a 68-year-old woman for community-acquired pneumonia with a past medical history of hypertension, gastroesophageal reflux disease, and osteoarthritis. Her hospitalist consults physical therapy to maximize mobility; continues her home medications including pantoprazole, hydrochlorothiazide, and acetaminophen; and initiates antimicrobial therapy with ceftriaxone and azithromycin. The hospital admission order set requires administration of subcutaneous unfractionated heparin for venous thromboembolism chemoprophylaxis.

Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), ranks among the leading preventable causes of morbidity and mortality in hospitalized patients.¹ DVTs can rapidly progress to a PE, which account for 5% to 10% of in-hospital deaths.¹ The negative sequelae of in-hospital VTE, including prolonged hospital stay, increased healthcare costs, and greater risks associated with pharmacologic treatment, add $9 to $18.2 billion in US healthcare expenditures each year.² Various risk-assessment models (RAMs) identify medical patients at high risk for developing VTE based on the presence of risk factors including acute heart failure, prior history of VTE, and reduced mobility.³ Since hospitalization may itself increase the risk for VTE, medical patients often receive universal chemoprophylaxis with anticoagulants such as unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), or fondaparinux.³ A meta-analysis of randomized controlled trials (RCTs) published by Wein et al supports the use of VTE chemoprophylaxis in high-risk patients.⁴ It showed statistically significant reductions in rates of PE in high-risk hospitalized medical patients with UFH (risk ratio [RR], 0.64; 95% CI, 0.50-0.82) or LMWH chemoprophylaxis (RR, 0.37; 95% CI, 0.21-0.64), compared with controls.

In recognition of the magnitude of the problem, national organizations have emphasized routine chemoprophylaxis for prevention of in-hospital VTE as a top-priority measure for patient safety.^5,6 The Joint Commission includes chemoprophylaxis as a quality core metric and failure to adhere to such standards compromises hospital accreditation.⁵ Since 2008, the Centers for Medicare & Medicaid Services no longer reimburses hospitals for preventable VTE and requires institutions to document the rationale for omitting chemoprophylaxis if not commenced on hospital admission.⁶

In order to understand why chemoprophylaxis fails to benefit low-risk medical patients, it is necessary to critically examine the benefits identified in trials of high-risk patients. Although RCTs and meta-analysis of chemoprophylaxis have consistently demonstrated a reduction in VTE, prevention of asymptomatic VTE identified on screening with ultrasound or venography accounts for more than 90% of the composite outcome in the three key trials.^7-9 Hospitalists do not routinely screen for asymptomatic VTE, and incorporation of these events into composite VTE outcomes inflates the magnitude of benefit gained by chemoprophylaxis. Importantly, the standard of care does not include screening for asymptomatic DVTs, and studies have estimated that only 10% to 15% of asymptomatic DVTs progress to a symptomatic VTE.¹⁰

A meta-analysis of trials evaluating unselected general medical patients (ie, not those with specific high-risk conditions such as acute myocardial infarction) did not show a reduction in symptomatic VTE with chemoprophylaxis (odds ratio [OR], 0.59; 95% CI, 0.29-1.23).¹¹ In the meta-analysis by Wein et al, which did include patients with specific high-risk conditions, chemoprophylaxis produced a small absolute risk reduction, resulting in a number needed to treat (NNT) of 345 to prevent one PE.⁴ This demonstrates that, even in high-risk patients, the magnitude of benefit is small. Population-level data also question the benefit of chemoprophylaxis. Flanders et al stratified 35 Michigan hospitals into high-, moderate-, and low-performance tertiles, with performance based on the rate of chemoprophylaxis use on admission for general medical patients at high-risk for VTE. The authors found no significant difference in the rate of VTE at 90 days among tertiles.¹² These findings question the usefulness of universal chemoprophylaxis when applied in a real-world setting.

The high rates of VTE in the absence of chemoprophylaxis reported in historic trials may overestimate the contemporary risk. A 2019 multicenter, observational study examined the rate of hospital-acquired DVT for 1,170 low- and high-risk patients with acute medical illness admitted to the internal medicine ward.¹³ Of them, 250 (21%) underwent prophylaxis with parenteral anticoagulants (mean Padua Prediction Score, 4.5). The remaining 920 (79%) were not treated with prophylaxis (mean Padua Prediction Score, 2.5). All patients underwent ultrasound at admission and discharge. The average length of stay was 13 days, and just three patients (0.3%) experienced in-hospital DVT, two of whom were receiving chemoprophylaxis. Only one (0.09%) DVT was symptomatic.

It should be emphasized that any evidence favoring chemoprophylaxis comes from studies of patients at high-risk of VTE. No data show benefit for low-risk patients. Therefore, any risk of chemoprophylaxis likely outweighs the benefits in low-risk patients. Importantly, the risks are underappreciated. A 2014 meta-analysis reported an increased risk of major hemorrhage (OR, 1.81; 95% CI, 1.10-2.98; P = .02) in high-risk medically ill patients on chemoprophylaxis.¹⁴ This results in a number needed to harm for major bleeding of 336, a value similar to the NNT for benefit reported by Wein et al.⁴ Heparin-induced thrombocytopenia, a potentially limb- and life-threatening complication of UFH or LMWH exposure, has an overall incidence of 0.3% to 0.7% in hospitalized patients on chemoprophylaxis.³ Finally, the most commonly used chemoprophylaxis medications are administered subcutaneously, resulting in injection site pain. Unsurprisingly, hospitalized patients refuse chemoprophylaxis more frequently than any other medication.¹⁵

The negative implications of inappropriate chemoprophylaxis extend beyond direct harms to patients. Poor stratification and overuse results in unnecessary healthcare costs. One single-center retrospective review demonstrated that, after integration of chemoprophylaxis into hospital order sets, 76% of patients received unnecessary administration of chemoprophylaxis, resulting in an annualized expenditure of $77,652.¹⁶ This does not take into account costs associated with major bleeds.

Unfortunately, the pendulum has shifted from an era of underprescribing chemoprophylaxis to hospitalized medical patients to one of overprescribing. Data published in 2018 suggest that providers overuse chemoprophylaxis in low-risk medical patients at more than double the rate of underusing it in high-risk patients (57% vs 21%).¹⁷

Several national societies, including the often cited American College of Chest Physicians (ACCP) and American Society of Hematology (ASH), provide guidance on the use of VTE chemoprophylaxis in acutely ill medical inpatients.^3,18 The ASH guidelines conditionally recommend VTE chemoprophylaxis rather than no chemoprophylaxis.¹⁸ However, the guidelines do not provide guidance on a risk-stratified approach and disclose that this recommendation is supported by a low certainty in the evidence of the net health benefit gained.¹⁸ Guidelines from ACCP lean towards individualized care and recommend against the use of VTE chemoprophylaxis for hospitalized acutely ill, low-risk medical patients.³

Clinicians should risk stratify using validated RAMs when making a patient-centered treatment plan on admission. The table outlines the most common RAMs with evidence for use in acute medically ill hospitalized patients. Although RAMs have limitations (eg, lack of prospective validation and complexity), the ACCP guidelines advocate for their use.³

Given that immobility independently increases risk for VTE, early mobilization is a simple and cost-effective way to potentially prevent VTE in low-risk patients. In addition to this potential benefit, early mobilization shortens the length of hospital stay, improves functional status and rates of delirium in hospitalized elderly patients, and hastens postoperative recovery after major surgeries.¹⁹

• Incorporate a patient-centered, risk-stratified approach to identify low-risk patients. This can be done manually or with use of RAMS embedded in the electronic health record.
• Do not prescribe chemoprophylaxis to low-risk hospitalized medical patients.
• Emphasize the importance of early mobilization in hospitalized patients.

In regard to the case, the hospitalist should use a RAM developed for the nonsurgical, non–critically ill patient to determine her need for chemoprophylaxis. Based on the clinical data presented, the three RAMs available would classify the patient as low risk for developing an in-hospital VTE. She should not receive chemoprophylaxis given the lack of data demonstrating benefit in this population. To mitigate the potential risk of bleeding, heparin-induced thrombocytopenia, and painful injections, the hospitalist should discontinue heparin. The hospitalist should advocate for early mobilization and minimize the duration of hospital stay as appropriate.

Do you think this is a low-value practice? Is this truly a “Thing We Do for No Reason^™”? Share what you do in your practice and join in the conversation online by retweeting it on Twitter (#TWDFNR) and liking it on Facebook. We invite you to propose ideas for other “Things We Do for No Reason^™” topics by emailing [email protected].

There is a growing appreciation of gender disparities in career advancement in medicine. By 2004, approximately 50% of medical school graduates were women, yet considerable differences persist between genders in compensation, faculty rank, and leadership positions.^1-3 According to the Association of American Medical Colleges (AAMC), women account for only 25% of full professors, 18% of department chairs, and 18% of medical school deans.¹ Women are also underrepresented in other areas of leadership such as division directors, professional society leadership, and hospital executives.^4-6

Specialties that are predominantly women, including pediatrics, are not immune to gender disparities. Women represent 71% of pediatric residents¹ and currently constitute two-thirds of active pediatricians in the United States.⁷ However, there is a disproportionately low number of women ascending the pediatric academic ladder, with only 35% of full professors² and 28% of department chairs being women.¹ Pediatrics also was noted to have the fifth-largest gender pay gap across 40 specialties.³ These disparities can contribute to burnout, poorer patient outcomes, and decreased advancement of women known as the “leaky pipeline.”^1,8,9

There is some evidence that gender disparities may be improving among younger professionals with increasing percentages of women as leaders and decreasing pay gaps.^10,11 These potential positive trends provide hope that fields in medicine early in their development may demonstrate fewer gender disparities. One of the youngest fields of medicine is pediatric hospital medicine (PHM), which officially became a recognized pediatric subspecialty in 2017.¹² There is no literature to date describing gender disparities in PHM. We aimed to explore the gender distribution of university-based PHM program leadership and to compare this gender distribution with that seen in the broader field of PHM.

This study was Institutional Review Board–approved as non–human subjects research through University of Chicago, Chicago, Illinois. From January to March 2020, the authors performed web-based searches for PHM division directors or program leaders in the United States. Because there is no single database of PHM programs in the United States, we used the AAMC list of Liaison Committee on Medical Education (LCME)–accredited US medical schools; medical schools in Puerto Rico were not included, nor were pending and provisional institutions. If an institution had multiple practice sites for its students, the primary site for third-year medical student clerkship rotations was included. If a medical school had multiple branches, each with its own primary inpatient pediatrics site, these sites were included. If there was no PHM division director, a program leader (lead hospitalist) was substituted and counted as long as the role was formally designated. This leadership role is herein referred to under the umbrella term of “division director.”

We searched medical school web pages, affiliated hospital web pages, and Google. All program leadership information (divisional and fellowship, if present) was confirmed through direct communication with the program, most commonly with division directors, and included name, gender, title, and presence of associate/assistant leader, gender, and title. Associate division directors were only included if it was a formal leadership position. Associate directors of research, quality, etc, were not included due to the limited number of formal positions noted on further review. Of note, the terms “associate” and “assistant” are referring to leadership positions and not academic ranks.

Fellowship leadership was included if affiliated with a US medical school in the primary list. Medical schools with multiple PHM fellowships were included as separate observations. The leadership was confirmed using the methods described above and cross-referenced through the PHM Fellowship Program website. PHM fellowship programs starting in 2020 were included if leadership was determined.

All leadership positions were verified by two authors, and all authors reviewed the master list to identify errors.

To determine the overall gender breakdown in the specialty, we used three estimates: 2019 American Board of Pediatrics (ABP) PHM Board Certification Exam applicants, the 2019 American Academy of Pediatrics Section on Hospital Medicine membership, and a random sample of all PHM faculty in 25% of the programs included in this study.⁴

Descriptive statistics using 95% confidence intervals for proportions were used. Differences between proportions were evaluated using a two-proportion z test with the null hypothesis that the two proportions are the same and significance set at P < .05. 

Of the 150 AAMC LCME–accredited medical school departments of pediatrics evaluated, a total of 142 programs were included; eight programs were excluded due to not providing inpatient pediatric services.

Division Leadership

The proportion of women PHM division directors was 55% (95% CI, 47%-63%) in this sample of 146 leaders from 142 programs (4 programs had coleaders). In the 113 programs with standalone PHM divisions or sections, the proportion of women division directors was 56% (95% CI, 47%-64%). In the 29 hospitalist groups that were not standalone (ie, embedded in another division), the proportion of women leaders was similar at 52% (95% CI, 34%-69%). In 24 programs with 27 formally designated associate directors (1 program had 3 associate directors and 1 program had 2), 81% of associate directors were women (95% CI, 63%-92%).

Fellowship Leadership

A total of 51 PHM fellowship programs had 53 directors (2 had codirectors), and 66% of the fellowship directors were women (95% CI, 53%-77%). A total of 31 programs had 34 assistant directors (3 programs had 2 assistants), and 82% of the assistant fellowship directors were women (95% CI, 66%-92%).

Comparison With the Field at Large

The inaugural ABP PHM board certification exam in 2019 had 1,627 applicants with 70% women (95% CI, 68%-73%) (Suzanne Woods, MD, email communication, December 4, 2019). The American Academy of Pediatrics Section on Hospital Medicine, the largest PHM-specific organization, has 2,299 practicing physician members with 71% women (95% CI, 69%-73%) (Niccole Alexander, email communication, November 25, 2019). Our random sample of 25% of university-based PHM programs contained 1,063 faculty members with 72% women (95% CI, 69%-75%).

The Table provides P values for comparisons of the proportion of women in each of the above-described leadership roles compared to the most conservative estimate of women in the field from the estimates given above (ie, 70%). Compared with the field at large, women appear to be underrepresented as division directors (70% vs 55%; P < .001) but not as fellowship directors (70% vs 66%; P = .5). There is a higher proportion of women in all associate/assistant director roles, compared with the population (82% vs 70%; P = .04).

We found a significant difference between the proportion of women as PHM division directors (55%) when compared with the proportion of women physicians in PHM (70%), which suggests that women are underrepresented in clinical leadership at university-based pediatric hospitalist programs. Similar findings are described in other specialties, including notably adult hospital medicine.⁴ Burden et al found that only 16% of hospital medicine program leaders were women despite an equal number of women and men in the field. PHM has a much larger proportion of women, compared with that of hospital medicine, and yet women are still underrepresented as program leaders.

We found no disparities between the proportion of women as PHM fellowship directors and the field at large. These results are similar to those of other studies, which showed a higher number of women in educational leadership roles and lower representation in roles with influence over policy and allocation of resources.^13,14 Although the proportion of women in educational roles itself is not a concern, there is evidence that these positions may be undervalued by some institutions, which provide these positions with lower salaries and fewer opportunities for career advancement.^13,14

Interestingly, women are well-represented in associate/assistant director roles at both the division and fellowship leader level when comparing the distribution in those roles with that of the PHM field at large. This finding suggests that the pipeline of women is robust and potentially may indicate positive change. Alternatively, this finding may reflect a previously described phenomenon of the “sticky floor” in which women are “stuck” in these supportive roles and do not necessarily advance to higher-impact positions.¹⁵ We found a statistically significant higher proportion of women in the combined group of all associate/assistant directors compared with the overall population, which raises the concern that supportive leadership roles may represent “women’s work.”¹⁶ Future studies are needed to track whether these women truly advance or whether women are overrepresented in supportive leadership positions at the expense of primary leadership positions.

Adequate representation of women alone is not sufficient to achieve gender equity in medicine. We need to understand why there is a lower representation of women in leadership positions. Some barriers have already been described, including gender bias in promotions,¹⁷ higher demands outside of work,¹⁸ and lower pay,³ though none are specific to PHM. A further qualitative exploration of PHM leadership would help describe any barriers women in PHM specifically may be facing in their career trajectory. In addition, more information is needed to explore the experience of women with intersectional identities in PHM, especially since they may experience increased bias and discrimination.¹⁹

Limitations of this study include the lack of a centralized list of PHM programs and data on PHM workforce. Our three estimates for the proportion of women in PHM were similar at 70%-71%; however, these are only proxies for the true gender distribution of PHM physicians, which is unknown. PHM leadership targets of close to 70% women would be reflective of the field at large; however, institutional variation may exist, and ideally leadership should be diverse and reflective of its faculty members. Our study only describes university-based PHM programs and, therefore, is not necessarily generalizable to nonuniversity programs. Further studies are needed to evaluate any potential differences based on program type. In our study, gender was used in binary terms; however, we acknowledge that gender exists on a spectrum.

As a specialty early in development with a robust pipeline of women, PHM is in a unique position to lead the way in gender equity. However, women appear to be underrepresented as division directors at university-based PHM programs. Achieving proportional representation of women leaders is imperative for tapping into the full potential of the community and ensuring that the goals of the field are representative of the population.

Special thanks to Lucille Lester, MD, who asked the question that started this road to discovery.

There is a growing appreciation of gender disparities in career advancement in medicine. By 2004, approximately 50% of medical school graduates were women, yet considerable differences persist between genders in compensation, faculty rank, and leadership positions.^1-3 According to the Association of American Medical Colleges (AAMC), women account for only 25% of full professors, 18% of department chairs, and 18% of medical school deans.¹ Women are also underrepresented in other areas of leadership such as division directors, professional society leadership, and hospital executives.^4-6

Specialties that are predominantly women, including pediatrics, are not immune to gender disparities. Women represent 71% of pediatric residents¹ and currently constitute two-thirds of active pediatricians in the United States.⁷ However, there is a disproportionately low number of women ascending the pediatric academic ladder, with only 35% of full professors² and 28% of department chairs being women.¹ Pediatrics also was noted to have the fifth-largest gender pay gap across 40 specialties.³ These disparities can contribute to burnout, poorer patient outcomes, and decreased advancement of women known as the “leaky pipeline.”^1,8,9

There is some evidence that gender disparities may be improving among younger professionals with increasing percentages of women as leaders and decreasing pay gaps.^10,11 These potential positive trends provide hope that fields in medicine early in their development may demonstrate fewer gender disparities. One of the youngest fields of medicine is pediatric hospital medicine (PHM), which officially became a recognized pediatric subspecialty in 2017.¹² There is no literature to date describing gender disparities in PHM. We aimed to explore the gender distribution of university-based PHM program leadership and to compare this gender distribution with that seen in the broader field of PHM.

This study was Institutional Review Board–approved as non–human subjects research through University of Chicago, Chicago, Illinois. From January to March 2020, the authors performed web-based searches for PHM division directors or program leaders in the United States. Because there is no single database of PHM programs in the United States, we used the AAMC list of Liaison Committee on Medical Education (LCME)–accredited US medical schools; medical schools in Puerto Rico were not included, nor were pending and provisional institutions. If an institution had multiple practice sites for its students, the primary site for third-year medical student clerkship rotations was included. If a medical school had multiple branches, each with its own primary inpatient pediatrics site, these sites were included. If there was no PHM division director, a program leader (lead hospitalist) was substituted and counted as long as the role was formally designated. This leadership role is herein referred to under the umbrella term of “division director.”

We searched medical school web pages, affiliated hospital web pages, and Google. All program leadership information (divisional and fellowship, if present) was confirmed through direct communication with the program, most commonly with division directors, and included name, gender, title, and presence of associate/assistant leader, gender, and title. Associate division directors were only included if it was a formal leadership position. Associate directors of research, quality, etc, were not included due to the limited number of formal positions noted on further review. Of note, the terms “associate” and “assistant” are referring to leadership positions and not academic ranks.

Fellowship leadership was included if affiliated with a US medical school in the primary list. Medical schools with multiple PHM fellowships were included as separate observations. The leadership was confirmed using the methods described above and cross-referenced through the PHM Fellowship Program website. PHM fellowship programs starting in 2020 were included if leadership was determined.

All leadership positions were verified by two authors, and all authors reviewed the master list to identify errors.

To determine the overall gender breakdown in the specialty, we used three estimates: 2019 American Board of Pediatrics (ABP) PHM Board Certification Exam applicants, the 2019 American Academy of Pediatrics Section on Hospital Medicine membership, and a random sample of all PHM faculty in 25% of the programs included in this study.⁴

Descriptive statistics using 95% confidence intervals for proportions were used. Differences between proportions were evaluated using a two-proportion z test with the null hypothesis that the two proportions are the same and significance set at P < .05. 

Of the 150 AAMC LCME–accredited medical school departments of pediatrics evaluated, a total of 142 programs were included; eight programs were excluded due to not providing inpatient pediatric services.

Division Leadership

The proportion of women PHM division directors was 55% (95% CI, 47%-63%) in this sample of 146 leaders from 142 programs (4 programs had coleaders). In the 113 programs with standalone PHM divisions or sections, the proportion of women division directors was 56% (95% CI, 47%-64%). In the 29 hospitalist groups that were not standalone (ie, embedded in another division), the proportion of women leaders was similar at 52% (95% CI, 34%-69%). In 24 programs with 27 formally designated associate directors (1 program had 3 associate directors and 1 program had 2), 81% of associate directors were women (95% CI, 63%-92%).

Fellowship Leadership

A total of 51 PHM fellowship programs had 53 directors (2 had codirectors), and 66% of the fellowship directors were women (95% CI, 53%-77%). A total of 31 programs had 34 assistant directors (3 programs had 2 assistants), and 82% of the assistant fellowship directors were women (95% CI, 66%-92%).

Comparison With the Field at Large

The inaugural ABP PHM board certification exam in 2019 had 1,627 applicants with 70% women (95% CI, 68%-73%) (Suzanne Woods, MD, email communication, December 4, 2019). The American Academy of Pediatrics Section on Hospital Medicine, the largest PHM-specific organization, has 2,299 practicing physician members with 71% women (95% CI, 69%-73%) (Niccole Alexander, email communication, November 25, 2019). Our random sample of 25% of university-based PHM programs contained 1,063 faculty members with 72% women (95% CI, 69%-75%).

The Table provides P values for comparisons of the proportion of women in each of the above-described leadership roles compared to the most conservative estimate of women in the field from the estimates given above (ie, 70%). Compared with the field at large, women appear to be underrepresented as division directors (70% vs 55%; P < .001) but not as fellowship directors (70% vs 66%; P = .5). There is a higher proportion of women in all associate/assistant director roles, compared with the population (82% vs 70%; P = .04).

We found a significant difference between the proportion of women as PHM division directors (55%) when compared with the proportion of women physicians in PHM (70%), which suggests that women are underrepresented in clinical leadership at university-based pediatric hospitalist programs. Similar findings are described in other specialties, including notably adult hospital medicine.⁴ Burden et al found that only 16% of hospital medicine program leaders were women despite an equal number of women and men in the field. PHM has a much larger proportion of women, compared with that of hospital medicine, and yet women are still underrepresented as program leaders.

We found no disparities between the proportion of women as PHM fellowship directors and the field at large. These results are similar to those of other studies, which showed a higher number of women in educational leadership roles and lower representation in roles with influence over policy and allocation of resources.^13,14 Although the proportion of women in educational roles itself is not a concern, there is evidence that these positions may be undervalued by some institutions, which provide these positions with lower salaries and fewer opportunities for career advancement.^13,14

Interestingly, women are well-represented in associate/assistant director roles at both the division and fellowship leader level when comparing the distribution in those roles with that of the PHM field at large. This finding suggests that the pipeline of women is robust and potentially may indicate positive change. Alternatively, this finding may reflect a previously described phenomenon of the “sticky floor” in which women are “stuck” in these supportive roles and do not necessarily advance to higher-impact positions.¹⁵ We found a statistically significant higher proportion of women in the combined group of all associate/assistant directors compared with the overall population, which raises the concern that supportive leadership roles may represent “women’s work.”¹⁶ Future studies are needed to track whether these women truly advance or whether women are overrepresented in supportive leadership positions at the expense of primary leadership positions.

Adequate representation of women alone is not sufficient to achieve gender equity in medicine. We need to understand why there is a lower representation of women in leadership positions. Some barriers have already been described, including gender bias in promotions,¹⁷ higher demands outside of work,¹⁸ and lower pay,³ though none are specific to PHM. A further qualitative exploration of PHM leadership would help describe any barriers women in PHM specifically may be facing in their career trajectory. In addition, more information is needed to explore the experience of women with intersectional identities in PHM, especially since they may experience increased bias and discrimination.¹⁹

Limitations of this study include the lack of a centralized list of PHM programs and data on PHM workforce. Our three estimates for the proportion of women in PHM were similar at 70%-71%; however, these are only proxies for the true gender distribution of PHM physicians, which is unknown. PHM leadership targets of close to 70% women would be reflective of the field at large; however, institutional variation may exist, and ideally leadership should be diverse and reflective of its faculty members. Our study only describes university-based PHM programs and, therefore, is not necessarily generalizable to nonuniversity programs. Further studies are needed to evaluate any potential differences based on program type. In our study, gender was used in binary terms; however, we acknowledge that gender exists on a spectrum.

As a specialty early in development with a robust pipeline of women, PHM is in a unique position to lead the way in gender equity. However, women appear to be underrepresented as division directors at university-based PHM programs. Achieving proportional representation of women leaders is imperative for tapping into the full potential of the community and ensuring that the goals of the field are representative of the population.

Special thanks to Lucille Lester, MD, who asked the question that started this road to discovery.

There is a growing appreciation of gender disparities in career advancement in medicine. By 2004, approximately 50% of medical school graduates were women, yet considerable differences persist between genders in compensation, faculty rank, and leadership positions.^1-3 According to the Association of American Medical Colleges (AAMC), women account for only 25% of full professors, 18% of department chairs, and 18% of medical school deans.¹ Women are also underrepresented in other areas of leadership such as division directors, professional society leadership, and hospital executives.^4-6

Specialties that are predominantly women, including pediatrics, are not immune to gender disparities. Women represent 71% of pediatric residents¹ and currently constitute two-thirds of active pediatricians in the United States.⁷ However, there is a disproportionately low number of women ascending the pediatric academic ladder, with only 35% of full professors² and 28% of department chairs being women.¹ Pediatrics also was noted to have the fifth-largest gender pay gap across 40 specialties.³ These disparities can contribute to burnout, poorer patient outcomes, and decreased advancement of women known as the “leaky pipeline.”^1,8,9

There is some evidence that gender disparities may be improving among younger professionals with increasing percentages of women as leaders and decreasing pay gaps.^10,11 These potential positive trends provide hope that fields in medicine early in their development may demonstrate fewer gender disparities. One of the youngest fields of medicine is pediatric hospital medicine (PHM), which officially became a recognized pediatric subspecialty in 2017.¹² There is no literature to date describing gender disparities in PHM. We aimed to explore the gender distribution of university-based PHM program leadership and to compare this gender distribution with that seen in the broader field of PHM.

This study was Institutional Review Board–approved as non–human subjects research through University of Chicago, Chicago, Illinois. From January to March 2020, the authors performed web-based searches for PHM division directors or program leaders in the United States. Because there is no single database of PHM programs in the United States, we used the AAMC list of Liaison Committee on Medical Education (LCME)–accredited US medical schools; medical schools in Puerto Rico were not included, nor were pending and provisional institutions. If an institution had multiple practice sites for its students, the primary site for third-year medical student clerkship rotations was included. If a medical school had multiple branches, each with its own primary inpatient pediatrics site, these sites were included. If there was no PHM division director, a program leader (lead hospitalist) was substituted and counted as long as the role was formally designated. This leadership role is herein referred to under the umbrella term of “division director.”

We searched medical school web pages, affiliated hospital web pages, and Google. All program leadership information (divisional and fellowship, if present) was confirmed through direct communication with the program, most commonly with division directors, and included name, gender, title, and presence of associate/assistant leader, gender, and title. Associate division directors were only included if it was a formal leadership position. Associate directors of research, quality, etc, were not included due to the limited number of formal positions noted on further review. Of note, the terms “associate” and “assistant” are referring to leadership positions and not academic ranks.

Fellowship leadership was included if affiliated with a US medical school in the primary list. Medical schools with multiple PHM fellowships were included as separate observations. The leadership was confirmed using the methods described above and cross-referenced through the PHM Fellowship Program website. PHM fellowship programs starting in 2020 were included if leadership was determined.

All leadership positions were verified by two authors, and all authors reviewed the master list to identify errors.

To determine the overall gender breakdown in the specialty, we used three estimates: 2019 American Board of Pediatrics (ABP) PHM Board Certification Exam applicants, the 2019 American Academy of Pediatrics Section on Hospital Medicine membership, and a random sample of all PHM faculty in 25% of the programs included in this study.⁴

Descriptive statistics using 95% confidence intervals for proportions were used. Differences between proportions were evaluated using a two-proportion z test with the null hypothesis that the two proportions are the same and significance set at P < .05. 

Of the 150 AAMC LCME–accredited medical school departments of pediatrics evaluated, a total of 142 programs were included; eight programs were excluded due to not providing inpatient pediatric services.

Division Leadership

The proportion of women PHM division directors was 55% (95% CI, 47%-63%) in this sample of 146 leaders from 142 programs (4 programs had coleaders). In the 113 programs with standalone PHM divisions or sections, the proportion of women division directors was 56% (95% CI, 47%-64%). In the 29 hospitalist groups that were not standalone (ie, embedded in another division), the proportion of women leaders was similar at 52% (95% CI, 34%-69%). In 24 programs with 27 formally designated associate directors (1 program had 3 associate directors and 1 program had 2), 81% of associate directors were women (95% CI, 63%-92%).

Fellowship Leadership

A total of 51 PHM fellowship programs had 53 directors (2 had codirectors), and 66% of the fellowship directors were women (95% CI, 53%-77%). A total of 31 programs had 34 assistant directors (3 programs had 2 assistants), and 82% of the assistant fellowship directors were women (95% CI, 66%-92%).

Comparison With the Field at Large

The inaugural ABP PHM board certification exam in 2019 had 1,627 applicants with 70% women (95% CI, 68%-73%) (Suzanne Woods, MD, email communication, December 4, 2019). The American Academy of Pediatrics Section on Hospital Medicine, the largest PHM-specific organization, has 2,299 practicing physician members with 71% women (95% CI, 69%-73%) (Niccole Alexander, email communication, November 25, 2019). Our random sample of 25% of university-based PHM programs contained 1,063 faculty members with 72% women (95% CI, 69%-75%).

The Table provides P values for comparisons of the proportion of women in each of the above-described leadership roles compared to the most conservative estimate of women in the field from the estimates given above (ie, 70%). Compared with the field at large, women appear to be underrepresented as division directors (70% vs 55%; P < .001) but not as fellowship directors (70% vs 66%; P = .5). There is a higher proportion of women in all associate/assistant director roles, compared with the population (82% vs 70%; P = .04).

We found a significant difference between the proportion of women as PHM division directors (55%) when compared with the proportion of women physicians in PHM (70%), which suggests that women are underrepresented in clinical leadership at university-based pediatric hospitalist programs. Similar findings are described in other specialties, including notably adult hospital medicine.⁴ Burden et al found that only 16% of hospital medicine program leaders were women despite an equal number of women and men in the field. PHM has a much larger proportion of women, compared with that of hospital medicine, and yet women are still underrepresented as program leaders.

We found no disparities between the proportion of women as PHM fellowship directors and the field at large. These results are similar to those of other studies, which showed a higher number of women in educational leadership roles and lower representation in roles with influence over policy and allocation of resources.^13,14 Although the proportion of women in educational roles itself is not a concern, there is evidence that these positions may be undervalued by some institutions, which provide these positions with lower salaries and fewer opportunities for career advancement.^13,14

Interestingly, women are well-represented in associate/assistant director roles at both the division and fellowship leader level when comparing the distribution in those roles with that of the PHM field at large. This finding suggests that the pipeline of women is robust and potentially may indicate positive change. Alternatively, this finding may reflect a previously described phenomenon of the “sticky floor” in which women are “stuck” in these supportive roles and do not necessarily advance to higher-impact positions.¹⁵ We found a statistically significant higher proportion of women in the combined group of all associate/assistant directors compared with the overall population, which raises the concern that supportive leadership roles may represent “women’s work.”¹⁶ Future studies are needed to track whether these women truly advance or whether women are overrepresented in supportive leadership positions at the expense of primary leadership positions.

Adequate representation of women alone is not sufficient to achieve gender equity in medicine. We need to understand why there is a lower representation of women in leadership positions. Some barriers have already been described, including gender bias in promotions,¹⁷ higher demands outside of work,¹⁸ and lower pay,³ though none are specific to PHM. A further qualitative exploration of PHM leadership would help describe any barriers women in PHM specifically may be facing in their career trajectory. In addition, more information is needed to explore the experience of women with intersectional identities in PHM, especially since they may experience increased bias and discrimination.¹⁹

Limitations of this study include the lack of a centralized list of PHM programs and data on PHM workforce. Our three estimates for the proportion of women in PHM were similar at 70%-71%; however, these are only proxies for the true gender distribution of PHM physicians, which is unknown. PHM leadership targets of close to 70% women would be reflective of the field at large; however, institutional variation may exist, and ideally leadership should be diverse and reflective of its faculty members. Our study only describes university-based PHM programs and, therefore, is not necessarily generalizable to nonuniversity programs. Further studies are needed to evaluate any potential differences based on program type. In our study, gender was used in binary terms; however, we acknowledge that gender exists on a spectrum.

As a specialty early in development with a robust pipeline of women, PHM is in a unique position to lead the way in gender equity. However, women appear to be underrepresented as division directors at university-based PHM programs. Achieving proportional representation of women leaders is imperative for tapping into the full potential of the community and ensuring that the goals of the field are representative of the population.

Special thanks to Lucille Lester, MD, who asked the question that started this road to discovery.