Venous thromboembolism (VTE) is a life-threatening event occurring with increasing frequency in hospitalized children and an incidence of more than 58 events per 10,000 hospitalizations.¹ In pediatric patients, VTEs occur less often than in adults, have bimodal peaks in neonates and adolescents, and are typically provoked, with central venous access as the most common risk factor.^1,

Treatment of pediatric VTE includes unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), and vitamin K antagonists (ie, warfarin). These agents have limitations, including parenteral administration, frequent lab monitoring, and drug/dietary interactions complicating use. Only recently have there been pediatric studies to assess these agents’ pharmacokinetics, pharmacodynamics, safety, and efficacy.²

Direct oral anticoagulants (DOACs) commonly used to treat VTE in adults have two mechanisms of action: direct thrombin (activated factor II) inhibition (ie, dabigatran) and activated factor X (Xa) inhibition (ie, rivaroxaban, apixaban, edoxaban, betrixaban). DOACs offer practical advantages over and efficacy similar to that of warfarin and heparin products, including oral administration, predictable pharmacology, no required lab monitoring, and fewer drug/dietary interactions. DOACs are already approved for VTE treatment in patients 18 years and older.³

This clinical practice update synthesizes 6 years (2014-2020) of literature regarding DOACs for treatment of VTE, focusing on their current role in patients 18 years and older and their emerging role in pediatric patients.

DOACs are approved by the US Food and Drug Administration (FDA) for multiple anticoagulation indications in adults, including treatment and prevention of acute VTE and prevention of stroke in nonvalvular atrial fibrillation (Table). DOACs are well tolerated by most adults; however, use in certain populations, including patients with liver disease with coagulopathy, advanced renal disease (creatinine clearance <30 mL/min), and class III obesity (body mass index [BMI] >40 kg/m²), requires caution.^4,5 For adult patients with VTE without contraindications, DOACs are considered equivalent to warfarin; current CHEST guidelines even suggest preference of DOACs over warfarin.⁵ While it is prudent to exercise caution when extrapolating adult data to children, these data have informed ongoing pediatric DOAC clinical trials.

The efficacy and safety of each of the DOACs (aside from betrixaban, which is indicated only for prophylaxis) have compared with warfarin for treatment of VTE in adults.⁶ A meta-analysis of six clinical trials determined DOACs are noninferior to warfarin for VTE treatment.³ Only two of six trials included patients with provoked VTEs. The meta-analysis found no difference in rates of recurrent symptomatic VTE (primary outcome; relative risk [RR], 0.91; 95% CI, 0.79-1.06) or all-cause mortality (secondary outcome; RR, 0.98; 95% CI, 0.84-1.14). Additionally, DOACs were shown as possibly safer than warfarin due to fewer major bleeding events, particularly fatal bleeding (RR, 0.36; 95% CI, 0.15-0.84) and intracranial bleeding (RR, 0.34; 95% CI, 0.17-0.69). For clinically relevant nonmajor bleeding (eg, gastrointestinal bleeding requiring <2 U packed red blood cells), results were similar (RR, 0.73; 95% CI, 0.58-0.93).

DOACs appear to have effectiveness comparable with that of warfarin. A retrospective matched cohort study of 59,525 patients with acute VTE compared outcomes of patients on DOACs (95% on rivaroxaban) with those of patients on warfarin.⁶ There were no differences in all-cause mortality or major bleeding. Another retrospective cohort study of 62,431 patients with acute VTE compared rivaroxaban and apixaban with warfarin, as well as rivaroxaban and apixaban with each other.⁷ There were no differences in 3- and 6-month mortality between warfarin and DOAC users or between rivaroxaban and apixaban users.

Initial approval of DOACs brought concerns about reversibility in the setting of bleeding or urgent procedural need. Clinical practice guidelines, primarily based on observational studies and laboratory parameters in vitro or in healthy volunteers, recommend activated prothrombin complex concentrates as a first-line intervention.⁸ However, specific agents have now been FDA-approved for DOAC reversal.

Idarucizumab is an FDA-approved (2015) monoclonal antibody with high affinity for dabigatran. Approval was based on a multicenter prospective cohort study of 503 patients taking dabigatran who presented with major bleeding (301 patients) or requiring an urgent surgery (202 patients).⁹ Idarucizumab resulted in a median time to bleeding cessation of 2.5 hours for those 134 patients in whom time to bleeding cessation could be assessed. Patients with intracranial bleeding were excluded from the timed portion because follow up imaging was not mandated. For those requiring surgery, 93% had normal periprocedural hemostasis.

Andexanet alfa is an FDA-approved (2018) drug for reversal of apixaban and rivaroxaban that acts as a catalytically inactive decoy Xa molecule, binding Xa inhibitors with high affinity. A multicenter prospective cohort study of 352 patients on Xa inhibitors with major bleeding found administration of andexanet alfa resulted in excellent or good hemostasis in 82% of patients (204/249 patients) at 12 hours.¹⁰ There was no difference between rivaroxaban and apixaban patients. Both idarucizumab and andexanet alfa remain expensive and not universally available, but availability and use will likely increase with time.

In pediatric patients, most VTEs are provoked, with the most common risk factor being presence of a central line. Frequency of this risk factor varies based on age (>60% of cases in older children and nearly 90% in neonates).¹ The most recent American Society of Hematology guidelines recommend treating pediatric symptomatic VTE with anticoagulation and treating asymptomatic VTE instead of observation.² These recommendations rely on evidence in adult patients due to the current paucity of evidence in pediatrics.

“Pediatric investigation plans” are the cornerstone for ongoing clinical trials of DOACs in pediatrics. While studies evaluating safety and efficacy of standard anticoagulants (UFH, LMWH, and warfarin) in pediatrics exist, clinical trials at the time of drug development did not include pediatric patients. This means none of the currently used anticoagulants were initially developed or approved for children.¹ Under the Pediatric Research Equity Act of 2007, the FDA requires pharmaceutical companies to submit a New Drug Application to perform pediatric studies of drugs deemed likely for use in pediatric patients. Pediatric investigation plans allow for establishing safety, efficacy, dosing, and administration routes in pediatric populations. All four DOACs currently approved for treatment of VTE in adults have ongoing efficacy and safety clinical trials for children.

The first and only published clinical trial of DOAC efficacy and safety in pediatrics compared rivaroxaban to standard treatment of acute VTE (Appendix Table).¹¹ The industry-sponsored, open-label EINSTEIN-Jr trial randomized patients aged 0 to 17 years 2:1 to weight-based rivaroxaban or standard treatment after receiving initial parenteral therapy for 5 to 9 days. While most patients were treated for at least 3 months, patients younger than 2 years with line-related thrombosis were treated for only 1 month. The study population mostly consisted of patients with initial, symptomatic, provoked VTE, with types ranging from cerebral venous sinus thrombosis to catheter-associated thrombosis. VTE risk factors, which varied by age, included presence of a central line, major infection, surgery, or trauma. While most VTEs in pediatric patients are expected to be central-line related, in the EINSTEIN-Jr trial only 25.2% of VTEs were central line–associated. The study evaluated symptomatic recurrent VTE (primary efficacy outcome) and clinically relevant bleeding (safety outcome). No significant difference was found between treatment groups in efficacy or safety outcomes, and there were no treatment-related deaths. While the trial was not powered to assess noninferiority due to low incidence of VTE in pediatrics, the absolute number of symptomatic recurrent VTEs was lower in the rivaroxaban group compared with the standard-care group (1% vs 3%). The investigators concluded that rivaroxaban is similarly efficacious and safe in children as compared with adults. FDA approval of rivaroxaban in pediatrics is expected given the trial’s favorable results. Clinicians may wish to consider whether the studied population is comparable with their own patients because the trial had a lower percentage of line-associated VTE than previously reported in the pediatric population.

Multiple clinical trials evaluating the efficacy and safety of other DOACs in pediatric patients are currently underway (Appendix Table).^12-14 Apixaban and edoxaban have active multicenter, randomized, open-label clinical trials recruiting patients up to age 17 who have imaging-confirmed acute VTE. A similar trial for dabigatran has recently completed recruitment. Outcome measures include recurrent VTE, VTE-related mortality, and major or clinically relevant non-major bleeding. Like EINSTEIN-Jr, patients in the dabigatran and edoxaban trials were treated with parenteral therapy for at least 5 days prior to randomization.^12,14 In the apixaban trial, participants can be randomized without initial parenteral treatment.¹³ Betrixaban, the newest DOAC approved in adults, does not currently have any open pediatric trials.

Lack of approved reversal agents may initially limit DOAC use in children. An open-label study examining idarucizumab safety has completed enrollment, but it has not yet published results.¹⁵ To date, there are no pediatric clinical trials examining andexanet alpha. Future work will need to establish efficacy and safety of reversal agents in pediatrics.

DOACs have not been adequately studied in populations of patients with comorbidities, such as liver disease, renal disease, altered enteral absorption, and BMI higher than 40. Physiologic differences in children with cancer and in neonates merit further evaluation of DOAC safety and efficacy. While ongoing trials established weight-based dosing regimens for children, longitudinal studies will need to ensure adequate anticoagulation, especially in the populations listed here.

The safety outcomes in most DOAC studies include clinically relevant bleeding and VTE-related mortality. These outcomes are much less common in pediatric patients than they are in adults, and future studies may need to expand safety outcomes to those more frequently seen in children. Primary and secondary endpoint variability in pediatric DOAC clinical trials presents challenges interpreting and comparing study results.

VTE is an increasingly common complication in hospitalized children contributing to significant morbidity.¹ For decades, the only treatment options have been UFH, LMWH, or warfarin. DOACs offer many advantages compared with standard anticoagulation options. The only clinical trial evaluating efficacy and safety of DOACs published to date demonstrates that pediatric patients taking rivaroxaban have outcomes similar to those of patients receiving standard care. It is expected that DOACs will gain FDA approval for treatment of VTE in pediatric patients in the near future; therefore, hospitalists should understand indications for use of these medications.

Venous thromboembolism (VTE) is a life-threatening event occurring with increasing frequency in hospitalized children and an incidence of more than 58 events per 10,000 hospitalizations.¹ In pediatric patients, VTEs occur less often than in adults, have bimodal peaks in neonates and adolescents, and are typically provoked, with central venous access as the most common risk factor.^1,

Treatment of pediatric VTE includes unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), and vitamin K antagonists (ie, warfarin). These agents have limitations, including parenteral administration, frequent lab monitoring, and drug/dietary interactions complicating use. Only recently have there been pediatric studies to assess these agents’ pharmacokinetics, pharmacodynamics, safety, and efficacy.²

Direct oral anticoagulants (DOACs) commonly used to treat VTE in adults have two mechanisms of action: direct thrombin (activated factor II) inhibition (ie, dabigatran) and activated factor X (Xa) inhibition (ie, rivaroxaban, apixaban, edoxaban, betrixaban). DOACs offer practical advantages over and efficacy similar to that of warfarin and heparin products, including oral administration, predictable pharmacology, no required lab monitoring, and fewer drug/dietary interactions. DOACs are already approved for VTE treatment in patients 18 years and older.³

This clinical practice update synthesizes 6 years (2014-2020) of literature regarding DOACs for treatment of VTE, focusing on their current role in patients 18 years and older and their emerging role in pediatric patients.

DOACs are approved by the US Food and Drug Administration (FDA) for multiple anticoagulation indications in adults, including treatment and prevention of acute VTE and prevention of stroke in nonvalvular atrial fibrillation (Table). DOACs are well tolerated by most adults; however, use in certain populations, including patients with liver disease with coagulopathy, advanced renal disease (creatinine clearance <30 mL/min), and class III obesity (body mass index [BMI] >40 kg/m²), requires caution.^4,5 For adult patients with VTE without contraindications, DOACs are considered equivalent to warfarin; current CHEST guidelines even suggest preference of DOACs over warfarin.⁵ While it is prudent to exercise caution when extrapolating adult data to children, these data have informed ongoing pediatric DOAC clinical trials.

The efficacy and safety of each of the DOACs (aside from betrixaban, which is indicated only for prophylaxis) have compared with warfarin for treatment of VTE in adults.⁶ A meta-analysis of six clinical trials determined DOACs are noninferior to warfarin for VTE treatment.³ Only two of six trials included patients with provoked VTEs. The meta-analysis found no difference in rates of recurrent symptomatic VTE (primary outcome; relative risk [RR], 0.91; 95% CI, 0.79-1.06) or all-cause mortality (secondary outcome; RR, 0.98; 95% CI, 0.84-1.14). Additionally, DOACs were shown as possibly safer than warfarin due to fewer major bleeding events, particularly fatal bleeding (RR, 0.36; 95% CI, 0.15-0.84) and intracranial bleeding (RR, 0.34; 95% CI, 0.17-0.69). For clinically relevant nonmajor bleeding (eg, gastrointestinal bleeding requiring <2 U packed red blood cells), results were similar (RR, 0.73; 95% CI, 0.58-0.93).

DOACs appear to have effectiveness comparable with that of warfarin. A retrospective matched cohort study of 59,525 patients with acute VTE compared outcomes of patients on DOACs (95% on rivaroxaban) with those of patients on warfarin.⁶ There were no differences in all-cause mortality or major bleeding. Another retrospective cohort study of 62,431 patients with acute VTE compared rivaroxaban and apixaban with warfarin, as well as rivaroxaban and apixaban with each other.⁷ There were no differences in 3- and 6-month mortality between warfarin and DOAC users or between rivaroxaban and apixaban users.

Initial approval of DOACs brought concerns about reversibility in the setting of bleeding or urgent procedural need. Clinical practice guidelines, primarily based on observational studies and laboratory parameters in vitro or in healthy volunteers, recommend activated prothrombin complex concentrates as a first-line intervention.⁸ However, specific agents have now been FDA-approved for DOAC reversal.

Idarucizumab is an FDA-approved (2015) monoclonal antibody with high affinity for dabigatran. Approval was based on a multicenter prospective cohort study of 503 patients taking dabigatran who presented with major bleeding (301 patients) or requiring an urgent surgery (202 patients).⁹ Idarucizumab resulted in a median time to bleeding cessation of 2.5 hours for those 134 patients in whom time to bleeding cessation could be assessed. Patients with intracranial bleeding were excluded from the timed portion because follow up imaging was not mandated. For those requiring surgery, 93% had normal periprocedural hemostasis.

Andexanet alfa is an FDA-approved (2018) drug for reversal of apixaban and rivaroxaban that acts as a catalytically inactive decoy Xa molecule, binding Xa inhibitors with high affinity. A multicenter prospective cohort study of 352 patients on Xa inhibitors with major bleeding found administration of andexanet alfa resulted in excellent or good hemostasis in 82% of patients (204/249 patients) at 12 hours.¹⁰ There was no difference between rivaroxaban and apixaban patients. Both idarucizumab and andexanet alfa remain expensive and not universally available, but availability and use will likely increase with time.

In pediatric patients, most VTEs are provoked, with the most common risk factor being presence of a central line. Frequency of this risk factor varies based on age (>60% of cases in older children and nearly 90% in neonates).¹ The most recent American Society of Hematology guidelines recommend treating pediatric symptomatic VTE with anticoagulation and treating asymptomatic VTE instead of observation.² These recommendations rely on evidence in adult patients due to the current paucity of evidence in pediatrics.

“Pediatric investigation plans” are the cornerstone for ongoing clinical trials of DOACs in pediatrics. While studies evaluating safety and efficacy of standard anticoagulants (UFH, LMWH, and warfarin) in pediatrics exist, clinical trials at the time of drug development did not include pediatric patients. This means none of the currently used anticoagulants were initially developed or approved for children.¹ Under the Pediatric Research Equity Act of 2007, the FDA requires pharmaceutical companies to submit a New Drug Application to perform pediatric studies of drugs deemed likely for use in pediatric patients. Pediatric investigation plans allow for establishing safety, efficacy, dosing, and administration routes in pediatric populations. All four DOACs currently approved for treatment of VTE in adults have ongoing efficacy and safety clinical trials for children.

The first and only published clinical trial of DOAC efficacy and safety in pediatrics compared rivaroxaban to standard treatment of acute VTE (Appendix Table).¹¹ The industry-sponsored, open-label EINSTEIN-Jr trial randomized patients aged 0 to 17 years 2:1 to weight-based rivaroxaban or standard treatment after receiving initial parenteral therapy for 5 to 9 days. While most patients were treated for at least 3 months, patients younger than 2 years with line-related thrombosis were treated for only 1 month. The study population mostly consisted of patients with initial, symptomatic, provoked VTE, with types ranging from cerebral venous sinus thrombosis to catheter-associated thrombosis. VTE risk factors, which varied by age, included presence of a central line, major infection, surgery, or trauma. While most VTEs in pediatric patients are expected to be central-line related, in the EINSTEIN-Jr trial only 25.2% of VTEs were central line–associated. The study evaluated symptomatic recurrent VTE (primary efficacy outcome) and clinically relevant bleeding (safety outcome). No significant difference was found between treatment groups in efficacy or safety outcomes, and there were no treatment-related deaths. While the trial was not powered to assess noninferiority due to low incidence of VTE in pediatrics, the absolute number of symptomatic recurrent VTEs was lower in the rivaroxaban group compared with the standard-care group (1% vs 3%). The investigators concluded that rivaroxaban is similarly efficacious and safe in children as compared with adults. FDA approval of rivaroxaban in pediatrics is expected given the trial’s favorable results. Clinicians may wish to consider whether the studied population is comparable with their own patients because the trial had a lower percentage of line-associated VTE than previously reported in the pediatric population.

Multiple clinical trials evaluating the efficacy and safety of other DOACs in pediatric patients are currently underway (Appendix Table).^12-14 Apixaban and edoxaban have active multicenter, randomized, open-label clinical trials recruiting patients up to age 17 who have imaging-confirmed acute VTE. A similar trial for dabigatran has recently completed recruitment. Outcome measures include recurrent VTE, VTE-related mortality, and major or clinically relevant non-major bleeding. Like EINSTEIN-Jr, patients in the dabigatran and edoxaban trials were treated with parenteral therapy for at least 5 days prior to randomization.^12,14 In the apixaban trial, participants can be randomized without initial parenteral treatment.¹³ Betrixaban, the newest DOAC approved in adults, does not currently have any open pediatric trials.

Lack of approved reversal agents may initially limit DOAC use in children. An open-label study examining idarucizumab safety has completed enrollment, but it has not yet published results.¹⁵ To date, there are no pediatric clinical trials examining andexanet alpha. Future work will need to establish efficacy and safety of reversal agents in pediatrics.

DOACs have not been adequately studied in populations of patients with comorbidities, such as liver disease, renal disease, altered enteral absorption, and BMI higher than 40. Physiologic differences in children with cancer and in neonates merit further evaluation of DOAC safety and efficacy. While ongoing trials established weight-based dosing regimens for children, longitudinal studies will need to ensure adequate anticoagulation, especially in the populations listed here.

The safety outcomes in most DOAC studies include clinically relevant bleeding and VTE-related mortality. These outcomes are much less common in pediatric patients than they are in adults, and future studies may need to expand safety outcomes to those more frequently seen in children. Primary and secondary endpoint variability in pediatric DOAC clinical trials presents challenges interpreting and comparing study results.

VTE is an increasingly common complication in hospitalized children contributing to significant morbidity.¹ For decades, the only treatment options have been UFH, LMWH, or warfarin. DOACs offer many advantages compared with standard anticoagulation options. The only clinical trial evaluating efficacy and safety of DOACs published to date demonstrates that pediatric patients taking rivaroxaban have outcomes similar to those of patients receiving standard care. It is expected that DOACs will gain FDA approval for treatment of VTE in pediatric patients in the near future; therefore, hospitalists should understand indications for use of these medications.

Venous thromboembolism (VTE) is a life-threatening event occurring with increasing frequency in hospitalized children and an incidence of more than 58 events per 10,000 hospitalizations.¹ In pediatric patients, VTEs occur less often than in adults, have bimodal peaks in neonates and adolescents, and are typically provoked, with central venous access as the most common risk factor.^1,

Treatment of pediatric VTE includes unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), and vitamin K antagonists (ie, warfarin). These agents have limitations, including parenteral administration, frequent lab monitoring, and drug/dietary interactions complicating use. Only recently have there been pediatric studies to assess these agents’ pharmacokinetics, pharmacodynamics, safety, and efficacy.²

Direct oral anticoagulants (DOACs) commonly used to treat VTE in adults have two mechanisms of action: direct thrombin (activated factor II) inhibition (ie, dabigatran) and activated factor X (Xa) inhibition (ie, rivaroxaban, apixaban, edoxaban, betrixaban). DOACs offer practical advantages over and efficacy similar to that of warfarin and heparin products, including oral administration, predictable pharmacology, no required lab monitoring, and fewer drug/dietary interactions. DOACs are already approved for VTE treatment in patients 18 years and older.³

This clinical practice update synthesizes 6 years (2014-2020) of literature regarding DOACs for treatment of VTE, focusing on their current role in patients 18 years and older and their emerging role in pediatric patients.

DOACs are approved by the US Food and Drug Administration (FDA) for multiple anticoagulation indications in adults, including treatment and prevention of acute VTE and prevention of stroke in nonvalvular atrial fibrillation (Table). DOACs are well tolerated by most adults; however, use in certain populations, including patients with liver disease with coagulopathy, advanced renal disease (creatinine clearance <30 mL/min), and class III obesity (body mass index [BMI] >40 kg/m²), requires caution.^4,5 For adult patients with VTE without contraindications, DOACs are considered equivalent to warfarin; current CHEST guidelines even suggest preference of DOACs over warfarin.⁵ While it is prudent to exercise caution when extrapolating adult data to children, these data have informed ongoing pediatric DOAC clinical trials.

The efficacy and safety of each of the DOACs (aside from betrixaban, which is indicated only for prophylaxis) have compared with warfarin for treatment of VTE in adults.⁶ A meta-analysis of six clinical trials determined DOACs are noninferior to warfarin for VTE treatment.³ Only two of six trials included patients with provoked VTEs. The meta-analysis found no difference in rates of recurrent symptomatic VTE (primary outcome; relative risk [RR], 0.91; 95% CI, 0.79-1.06) or all-cause mortality (secondary outcome; RR, 0.98; 95% CI, 0.84-1.14). Additionally, DOACs were shown as possibly safer than warfarin due to fewer major bleeding events, particularly fatal bleeding (RR, 0.36; 95% CI, 0.15-0.84) and intracranial bleeding (RR, 0.34; 95% CI, 0.17-0.69). For clinically relevant nonmajor bleeding (eg, gastrointestinal bleeding requiring <2 U packed red blood cells), results were similar (RR, 0.73; 95% CI, 0.58-0.93).

DOACs appear to have effectiveness comparable with that of warfarin. A retrospective matched cohort study of 59,525 patients with acute VTE compared outcomes of patients on DOACs (95% on rivaroxaban) with those of patients on warfarin.⁶ There were no differences in all-cause mortality or major bleeding. Another retrospective cohort study of 62,431 patients with acute VTE compared rivaroxaban and apixaban with warfarin, as well as rivaroxaban and apixaban with each other.⁷ There were no differences in 3- and 6-month mortality between warfarin and DOAC users or between rivaroxaban and apixaban users.

Initial approval of DOACs brought concerns about reversibility in the setting of bleeding or urgent procedural need. Clinical practice guidelines, primarily based on observational studies and laboratory parameters in vitro or in healthy volunteers, recommend activated prothrombin complex concentrates as a first-line intervention.⁸ However, specific agents have now been FDA-approved for DOAC reversal.

Idarucizumab is an FDA-approved (2015) monoclonal antibody with high affinity for dabigatran. Approval was based on a multicenter prospective cohort study of 503 patients taking dabigatran who presented with major bleeding (301 patients) or requiring an urgent surgery (202 patients).⁹ Idarucizumab resulted in a median time to bleeding cessation of 2.5 hours for those 134 patients in whom time to bleeding cessation could be assessed. Patients with intracranial bleeding were excluded from the timed portion because follow up imaging was not mandated. For those requiring surgery, 93% had normal periprocedural hemostasis.

Andexanet alfa is an FDA-approved (2018) drug for reversal of apixaban and rivaroxaban that acts as a catalytically inactive decoy Xa molecule, binding Xa inhibitors with high affinity. A multicenter prospective cohort study of 352 patients on Xa inhibitors with major bleeding found administration of andexanet alfa resulted in excellent or good hemostasis in 82% of patients (204/249 patients) at 12 hours.¹⁰ There was no difference between rivaroxaban and apixaban patients. Both idarucizumab and andexanet alfa remain expensive and not universally available, but availability and use will likely increase with time.

In pediatric patients, most VTEs are provoked, with the most common risk factor being presence of a central line. Frequency of this risk factor varies based on age (>60% of cases in older children and nearly 90% in neonates).¹ The most recent American Society of Hematology guidelines recommend treating pediatric symptomatic VTE with anticoagulation and treating asymptomatic VTE instead of observation.² These recommendations rely on evidence in adult patients due to the current paucity of evidence in pediatrics.

“Pediatric investigation plans” are the cornerstone for ongoing clinical trials of DOACs in pediatrics. While studies evaluating safety and efficacy of standard anticoagulants (UFH, LMWH, and warfarin) in pediatrics exist, clinical trials at the time of drug development did not include pediatric patients. This means none of the currently used anticoagulants were initially developed or approved for children.¹ Under the Pediatric Research Equity Act of 2007, the FDA requires pharmaceutical companies to submit a New Drug Application to perform pediatric studies of drugs deemed likely for use in pediatric patients. Pediatric investigation plans allow for establishing safety, efficacy, dosing, and administration routes in pediatric populations. All four DOACs currently approved for treatment of VTE in adults have ongoing efficacy and safety clinical trials for children.

The first and only published clinical trial of DOAC efficacy and safety in pediatrics compared rivaroxaban to standard treatment of acute VTE (Appendix Table).¹¹ The industry-sponsored, open-label EINSTEIN-Jr trial randomized patients aged 0 to 17 years 2:1 to weight-based rivaroxaban or standard treatment after receiving initial parenteral therapy for 5 to 9 days. While most patients were treated for at least 3 months, patients younger than 2 years with line-related thrombosis were treated for only 1 month. The study population mostly consisted of patients with initial, symptomatic, provoked VTE, with types ranging from cerebral venous sinus thrombosis to catheter-associated thrombosis. VTE risk factors, which varied by age, included presence of a central line, major infection, surgery, or trauma. While most VTEs in pediatric patients are expected to be central-line related, in the EINSTEIN-Jr trial only 25.2% of VTEs were central line–associated. The study evaluated symptomatic recurrent VTE (primary efficacy outcome) and clinically relevant bleeding (safety outcome). No significant difference was found between treatment groups in efficacy or safety outcomes, and there were no treatment-related deaths. While the trial was not powered to assess noninferiority due to low incidence of VTE in pediatrics, the absolute number of symptomatic recurrent VTEs was lower in the rivaroxaban group compared with the standard-care group (1% vs 3%). The investigators concluded that rivaroxaban is similarly efficacious and safe in children as compared with adults. FDA approval of rivaroxaban in pediatrics is expected given the trial’s favorable results. Clinicians may wish to consider whether the studied population is comparable with their own patients because the trial had a lower percentage of line-associated VTE than previously reported in the pediatric population.

Multiple clinical trials evaluating the efficacy and safety of other DOACs in pediatric patients are currently underway (Appendix Table).^12-14 Apixaban and edoxaban have active multicenter, randomized, open-label clinical trials recruiting patients up to age 17 who have imaging-confirmed acute VTE. A similar trial for dabigatran has recently completed recruitment. Outcome measures include recurrent VTE, VTE-related mortality, and major or clinically relevant non-major bleeding. Like EINSTEIN-Jr, patients in the dabigatran and edoxaban trials were treated with parenteral therapy for at least 5 days prior to randomization.^12,14 In the apixaban trial, participants can be randomized without initial parenteral treatment.¹³ Betrixaban, the newest DOAC approved in adults, does not currently have any open pediatric trials.

Lack of approved reversal agents may initially limit DOAC use in children. An open-label study examining idarucizumab safety has completed enrollment, but it has not yet published results.¹⁵ To date, there are no pediatric clinical trials examining andexanet alpha. Future work will need to establish efficacy and safety of reversal agents in pediatrics.

DOACs have not been adequately studied in populations of patients with comorbidities, such as liver disease, renal disease, altered enteral absorption, and BMI higher than 40. Physiologic differences in children with cancer and in neonates merit further evaluation of DOAC safety and efficacy. While ongoing trials established weight-based dosing regimens for children, longitudinal studies will need to ensure adequate anticoagulation, especially in the populations listed here.

The safety outcomes in most DOAC studies include clinically relevant bleeding and VTE-related mortality. These outcomes are much less common in pediatric patients than they are in adults, and future studies may need to expand safety outcomes to those more frequently seen in children. Primary and secondary endpoint variability in pediatric DOAC clinical trials presents challenges interpreting and comparing study results.

VTE is an increasingly common complication in hospitalized children contributing to significant morbidity.¹ For decades, the only treatment options have been UFH, LMWH, or warfarin. DOACs offer many advantages compared with standard anticoagulation options. The only clinical trial evaluating efficacy and safety of DOACs published to date demonstrates that pediatric patients taking rivaroxaban have outcomes similar to those of patients receiving standard care. It is expected that DOACs will gain FDA approval for treatment of VTE in pediatric patients in the near future; therefore, hospitalists should understand indications for use of these medications.

A 70-year-old woman with Medicare insurance and a history of mild dementia and chronic bronchiectasis was hospitalized for acute respiratory failure due to influenza. She was treated in the intensive care unit (ICU) for 2 days, received mechanical ventilation, and was subsequently extubated and weaned to high-flow nasal cannula (HFNC) at 8 liters of oxygen per minute and noninvasive ventilation at bedtime. She had otherwise stable cognition and required no other medical or nursing therapies. For recovery, she was referred to a skilled nursing facility (SNF) for respiratory support and rehabilitation but was declined due to HFNC use, noninvasive ventilation, and mild dementia. Instead, she was transferred to a long-term acute care hospital (LTACH) for respiratory support. In the context of major post-acute care (PAC) policy changes, where should—and could—this patient go to recover after hospitalization?

In 2018, 44% of hospitalized patients with fee-for-service Medicare (herein referred to as Medicare) were discharged to PAC, accounting for nearly $60 billion in annual Medicare spending.¹ PAC includes four levels of care—home health agencies (HHAs), SNFs, inpatient rehabilitation facilities (IRFs), and LTACHs—which vary in intensity and complexity of the medical, skilled nursing, and rehabilitative services they provide; use separate reimbursement systems; employ different quality metrics; and have different regulatory requirements (Table 1). Because hospitalists care for the majority of these patients and commonly serve in leadership roles for transitions of care and PAC use, PAC policy is important, as it has direct implications on discharge patterns and the quality and nature of patient care after discharge.

HHAs, the most commonly used PAC setting, provide skilled nursing or therapy to homebound beneficiaries.¹ HHAs were historically reimbursed a standardized 60-day episode payment based on casemix, which was highly dependent on the number of therapy visits provided, with extremely little contribution from nontherapy services, such as skilled nursing and home health aide visits.²

SNFs, which comprise nearly half of PAC spending, provide short-term skilled nursing and rehabilitative services following hospitalization. SNFs are reimbursed on a per diem basis by Medicare, with reimbursement historically determined by the intensity of the dominant service furnished to the patient—either nursing, ancillary care (which includes medications, supplies/equipment, and diagnostic testing), or rehabilitation.³ Due to strong financial incentives, payment for more than 90% of SNF days was based solely on rehabilitation therapy furnished, with 33% of SNF patients receiving ultra-high rehabilitation (>720 minutes/week),³even if it was not considered beneficial or within the patient’s goals of care.⁴

IRFs provide intensive rehabilitation to patients who are able to participate in at least 3 hours of multidisciplinary therapy per day.¹ IRF admissions are paid a bundled rate by Medicare based on the patient’s primary reason for rehabilitation, their age, and their level of functioning and cognition.

LTACHs, the most intensive and expensive PAC setting, care for patients with a range of complex hospital-level care needs, including intravenous (IV) infusions, complex wound care, and respiratory support. Since 2002, the only requirements for LTACHs have been to meet Medicare’s requirements for hospital accreditation and maintain an average length of stay of 25 days for their population.⁵ LTACH stays are paid a bundled rate by Medicare based on diagnosis.

Due to considerable variation in PAC use, with concerns that similar patients can be treated in different PAC settings,^6,7 the Centers for Medicare & Medicaid Services (CMS) recently introduced several major policy changes for HHAs, SNFs, and LTACHs (Table 1).¹ No major policy changes were made for IRFs.

For HHAs and SNFs, CMS implemented new payment models to better align payment with patients’ care needs rather than the provision of rehabilitation therapy.¹ For SNFs, the Patient
Driven Payment Model (PDPM) was implemented October 1, 2019, and for HHAs, the Patient-Driven Groupings Model (PDGM) was implemented January 1, 2020. These policies increase payment for patients who have nursing or ancillary care needs, such as IV medications, wound care, and respiratory support. For example, the per diem payment to SNFs is projected to increase 10% to 30% for patients needing dialysis, IV medications, wound care, and respiratory support, such as tracheostomy care.⁸ These policies also increase payment for patients with greater severity and complexity, such as patients with severe cognitive impairment and multimorbidity. Importantly, these policies pay HHAs and SNFs based on patients’ clinical needs and not solely based on the amount of rehabilitation therapy delivered, which could increase both the number and complexity of patients that SNFs accept.

To discourage LTACH use by patients who are unlikely to benefit from this level of care, CMS fully implemented the site-neutral payment policy on October 1, 2020 (although it is paused during the coronavirus disease 2019 [COVID-19] pandemic), which substantially decreased payment to LTACHs for patients who either did not have an ICU stay of 3 or more days preceding the transfer or did not receive prolonged mechanical ventilation in the LTACH for 96 or more hours.

Historically, PAC payment policy has not properly incentivized the appropriate amount of care to be delivered in the appropriate setting.⁹ The recent HHA, SNF, and LTACH policy changes not only shift the discharge of patients across PAC settings, but also change the amount and type of care that occurs at each PAC site (Table 2). The potential benefit of these new policies is that they will help to align the right level of PAC with patients’ needs by discouraging inappropriate use and unnecessary services. Under the new HHA and SNF payment models, initial media reports suggest a decline in therapy services has occurred, which could be beneficial if the therapy was excessive and not indicated.^4,10,11 Similarly, LTACHs are experiencing a large decline in admissions as fewer patients meet the new payment criteria.¹ As with all policy changes, the potential exists for unintended consequences. Because HHAs and SNFs are no longer incentivized to provide therapy, they might withhold the provision of needed rehabilitation therapy.¹⁰ Furthermore, because payments are based on patient coding by HHA and SNF providers under the new payment models, coding practices may change in order to optimize their payments. Indeed, the PDGM policy for HHAs includes a “behavioral adjustment” to account for anticipated changes in improved documentation by HHAs. Because LTACHs will be less likely to admit patients without prolonged mechanical ventilation or a qualifying ICU stay of 3 or more days, these patients might remain in the hospital for longer periods of time if they are too sick or their care needs are too complex for other PAC settings. Given these possible unintended consequences, the implications for hospital discharge patterns, PAC access, and quality of care will need to be closely monitored, as it is unclear how these PAC policy changes will impact patient care.

In terms of broader payment reform, the four PAC settings are still fragmented, with little effort to unify payment, regulation, and quality across the PAC continuum. As required by the Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014, we would encourage the adoption of a unified PAC payment system that spans the four settings, with payments based on patient characteristics and needs rather than site of service.¹² This type of reform would also harmonize regulation and quality measurement and reward payments across settings. Currently, CMS is standardizing patient assessment data and quality metrics across the four PAC settings. Given the COVID-19 pandemic, the transition to a unified PAC payment system is likely several years away.

For our patient who was transferred to an LTACH after referrals to SNFs were denied, PAC options now differ following these major PAC policy reforms, and SNF transfer would be an option. This is because SNFs will receive higher payment for providing respiratory support under the PDPM, and LTACHs will receive considerably lower reimbursement because the patient did not have a qualifying ICU stay or require prolonged mechanical ventilation. Furthermore, hospitals participating in accountable care organizations would achieve greater savings, given that LTACHs cost at least three times as much as SNFs for comparable diagnoses.

Instead of referring this patient to a LTACH, the care team (hospitalist, discharge navigator, and case manager) should inform and educate the patient about discharge options to SNFs for weaning from respiratory support. To help patients and caregivers choose a facility, the discharge planning team should provide data about the quality of SNFs (eg, CMS Star Ratings scores) instead of simply providing a list of names and locations.^13,14 Discharge planning should start as soon as possible to permit caregivers an opportunity to visit facilities and for the providers to coordinate the transfer as seamlessly as possible.

Recent major PAC policy changes will change where hospitals discharge medically complex patients and the services they will receive at these PAC settings. Historically, reduction in PAC use has been a key source for savings in alternative payment models that encourage value over volume, such as accountable care organizations and episode-based (“bundled”) payment models.¹⁵ We anticipate these PAC policy changes are a step in the right direction to further enable hospitals to achieve value by more closely aligning PAC incentives with patients’ needs.

A 70-year-old woman with Medicare insurance and a history of mild dementia and chronic bronchiectasis was hospitalized for acute respiratory failure due to influenza. She was treated in the intensive care unit (ICU) for 2 days, received mechanical ventilation, and was subsequently extubated and weaned to high-flow nasal cannula (HFNC) at 8 liters of oxygen per minute and noninvasive ventilation at bedtime. She had otherwise stable cognition and required no other medical or nursing therapies. For recovery, she was referred to a skilled nursing facility (SNF) for respiratory support and rehabilitation but was declined due to HFNC use, noninvasive ventilation, and mild dementia. Instead, she was transferred to a long-term acute care hospital (LTACH) for respiratory support. In the context of major post-acute care (PAC) policy changes, where should—and could—this patient go to recover after hospitalization?

In 2018, 44% of hospitalized patients with fee-for-service Medicare (herein referred to as Medicare) were discharged to PAC, accounting for nearly $60 billion in annual Medicare spending.¹ PAC includes four levels of care—home health agencies (HHAs), SNFs, inpatient rehabilitation facilities (IRFs), and LTACHs—which vary in intensity and complexity of the medical, skilled nursing, and rehabilitative services they provide; use separate reimbursement systems; employ different quality metrics; and have different regulatory requirements (Table 1). Because hospitalists care for the majority of these patients and commonly serve in leadership roles for transitions of care and PAC use, PAC policy is important, as it has direct implications on discharge patterns and the quality and nature of patient care after discharge.

HHAs, the most commonly used PAC setting, provide skilled nursing or therapy to homebound beneficiaries.¹ HHAs were historically reimbursed a standardized 60-day episode payment based on casemix, which was highly dependent on the number of therapy visits provided, with extremely little contribution from nontherapy services, such as skilled nursing and home health aide visits.²

SNFs, which comprise nearly half of PAC spending, provide short-term skilled nursing and rehabilitative services following hospitalization. SNFs are reimbursed on a per diem basis by Medicare, with reimbursement historically determined by the intensity of the dominant service furnished to the patient—either nursing, ancillary care (which includes medications, supplies/equipment, and diagnostic testing), or rehabilitation.³ Due to strong financial incentives, payment for more than 90% of SNF days was based solely on rehabilitation therapy furnished, with 33% of SNF patients receiving ultra-high rehabilitation (>720 minutes/week),³even if it was not considered beneficial or within the patient’s goals of care.⁴

IRFs provide intensive rehabilitation to patients who are able to participate in at least 3 hours of multidisciplinary therapy per day.¹ IRF admissions are paid a bundled rate by Medicare based on the patient’s primary reason for rehabilitation, their age, and their level of functioning and cognition.

LTACHs, the most intensive and expensive PAC setting, care for patients with a range of complex hospital-level care needs, including intravenous (IV) infusions, complex wound care, and respiratory support. Since 2002, the only requirements for LTACHs have been to meet Medicare’s requirements for hospital accreditation and maintain an average length of stay of 25 days for their population.⁵ LTACH stays are paid a bundled rate by Medicare based on diagnosis.

Due to considerable variation in PAC use, with concerns that similar patients can be treated in different PAC settings,^6,7 the Centers for Medicare & Medicaid Services (CMS) recently introduced several major policy changes for HHAs, SNFs, and LTACHs (Table 1).¹ No major policy changes were made for IRFs.

For HHAs and SNFs, CMS implemented new payment models to better align payment with patients’ care needs rather than the provision of rehabilitation therapy.¹ For SNFs, the Patient
Driven Payment Model (PDPM) was implemented October 1, 2019, and for HHAs, the Patient-Driven Groupings Model (PDGM) was implemented January 1, 2020. These policies increase payment for patients who have nursing or ancillary care needs, such as IV medications, wound care, and respiratory support. For example, the per diem payment to SNFs is projected to increase 10% to 30% for patients needing dialysis, IV medications, wound care, and respiratory support, such as tracheostomy care.⁸ These policies also increase payment for patients with greater severity and complexity, such as patients with severe cognitive impairment and multimorbidity. Importantly, these policies pay HHAs and SNFs based on patients’ clinical needs and not solely based on the amount of rehabilitation therapy delivered, which could increase both the number and complexity of patients that SNFs accept.

To discourage LTACH use by patients who are unlikely to benefit from this level of care, CMS fully implemented the site-neutral payment policy on October 1, 2020 (although it is paused during the coronavirus disease 2019 [COVID-19] pandemic), which substantially decreased payment to LTACHs for patients who either did not have an ICU stay of 3 or more days preceding the transfer or did not receive prolonged mechanical ventilation in the LTACH for 96 or more hours.

Historically, PAC payment policy has not properly incentivized the appropriate amount of care to be delivered in the appropriate setting.⁹ The recent HHA, SNF, and LTACH policy changes not only shift the discharge of patients across PAC settings, but also change the amount and type of care that occurs at each PAC site (Table 2). The potential benefit of these new policies is that they will help to align the right level of PAC with patients’ needs by discouraging inappropriate use and unnecessary services. Under the new HHA and SNF payment models, initial media reports suggest a decline in therapy services has occurred, which could be beneficial if the therapy was excessive and not indicated.^4,10,11 Similarly, LTACHs are experiencing a large decline in admissions as fewer patients meet the new payment criteria.¹ As with all policy changes, the potential exists for unintended consequences. Because HHAs and SNFs are no longer incentivized to provide therapy, they might withhold the provision of needed rehabilitation therapy.¹⁰ Furthermore, because payments are based on patient coding by HHA and SNF providers under the new payment models, coding practices may change in order to optimize their payments. Indeed, the PDGM policy for HHAs includes a “behavioral adjustment” to account for anticipated changes in improved documentation by HHAs. Because LTACHs will be less likely to admit patients without prolonged mechanical ventilation or a qualifying ICU stay of 3 or more days, these patients might remain in the hospital for longer periods of time if they are too sick or their care needs are too complex for other PAC settings. Given these possible unintended consequences, the implications for hospital discharge patterns, PAC access, and quality of care will need to be closely monitored, as it is unclear how these PAC policy changes will impact patient care.

In terms of broader payment reform, the four PAC settings are still fragmented, with little effort to unify payment, regulation, and quality across the PAC continuum. As required by the Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014, we would encourage the adoption of a unified PAC payment system that spans the four settings, with payments based on patient characteristics and needs rather than site of service.¹² This type of reform would also harmonize regulation and quality measurement and reward payments across settings. Currently, CMS is standardizing patient assessment data and quality metrics across the four PAC settings. Given the COVID-19 pandemic, the transition to a unified PAC payment system is likely several years away.

For our patient who was transferred to an LTACH after referrals to SNFs were denied, PAC options now differ following these major PAC policy reforms, and SNF transfer would be an option. This is because SNFs will receive higher payment for providing respiratory support under the PDPM, and LTACHs will receive considerably lower reimbursement because the patient did not have a qualifying ICU stay or require prolonged mechanical ventilation. Furthermore, hospitals participating in accountable care organizations would achieve greater savings, given that LTACHs cost at least three times as much as SNFs for comparable diagnoses.

Instead of referring this patient to a LTACH, the care team (hospitalist, discharge navigator, and case manager) should inform and educate the patient about discharge options to SNFs for weaning from respiratory support. To help patients and caregivers choose a facility, the discharge planning team should provide data about the quality of SNFs (eg, CMS Star Ratings scores) instead of simply providing a list of names and locations.^13,14 Discharge planning should start as soon as possible to permit caregivers an opportunity to visit facilities and for the providers to coordinate the transfer as seamlessly as possible.

Recent major PAC policy changes will change where hospitals discharge medically complex patients and the services they will receive at these PAC settings. Historically, reduction in PAC use has been a key source for savings in alternative payment models that encourage value over volume, such as accountable care organizations and episode-based (“bundled”) payment models.¹⁵ We anticipate these PAC policy changes are a step in the right direction to further enable hospitals to achieve value by more closely aligning PAC incentives with patients’ needs.

A 70-year-old woman with Medicare insurance and a history of mild dementia and chronic bronchiectasis was hospitalized for acute respiratory failure due to influenza. She was treated in the intensive care unit (ICU) for 2 days, received mechanical ventilation, and was subsequently extubated and weaned to high-flow nasal cannula (HFNC) at 8 liters of oxygen per minute and noninvasive ventilation at bedtime. She had otherwise stable cognition and required no other medical or nursing therapies. For recovery, she was referred to a skilled nursing facility (SNF) for respiratory support and rehabilitation but was declined due to HFNC use, noninvasive ventilation, and mild dementia. Instead, she was transferred to a long-term acute care hospital (LTACH) for respiratory support. In the context of major post-acute care (PAC) policy changes, where should—and could—this patient go to recover after hospitalization?

In 2018, 44% of hospitalized patients with fee-for-service Medicare (herein referred to as Medicare) were discharged to PAC, accounting for nearly $60 billion in annual Medicare spending.¹ PAC includes four levels of care—home health agencies (HHAs), SNFs, inpatient rehabilitation facilities (IRFs), and LTACHs—which vary in intensity and complexity of the medical, skilled nursing, and rehabilitative services they provide; use separate reimbursement systems; employ different quality metrics; and have different regulatory requirements (Table 1). Because hospitalists care for the majority of these patients and commonly serve in leadership roles for transitions of care and PAC use, PAC policy is important, as it has direct implications on discharge patterns and the quality and nature of patient care after discharge.

HHAs, the most commonly used PAC setting, provide skilled nursing or therapy to homebound beneficiaries.¹ HHAs were historically reimbursed a standardized 60-day episode payment based on casemix, which was highly dependent on the number of therapy visits provided, with extremely little contribution from nontherapy services, such as skilled nursing and home health aide visits.²

SNFs, which comprise nearly half of PAC spending, provide short-term skilled nursing and rehabilitative services following hospitalization. SNFs are reimbursed on a per diem basis by Medicare, with reimbursement historically determined by the intensity of the dominant service furnished to the patient—either nursing, ancillary care (which includes medications, supplies/equipment, and diagnostic testing), or rehabilitation.³ Due to strong financial incentives, payment for more than 90% of SNF days was based solely on rehabilitation therapy furnished, with 33% of SNF patients receiving ultra-high rehabilitation (>720 minutes/week),³even if it was not considered beneficial or within the patient’s goals of care.⁴

IRFs provide intensive rehabilitation to patients who are able to participate in at least 3 hours of multidisciplinary therapy per day.¹ IRF admissions are paid a bundled rate by Medicare based on the patient’s primary reason for rehabilitation, their age, and their level of functioning and cognition.

LTACHs, the most intensive and expensive PAC setting, care for patients with a range of complex hospital-level care needs, including intravenous (IV) infusions, complex wound care, and respiratory support. Since 2002, the only requirements for LTACHs have been to meet Medicare’s requirements for hospital accreditation and maintain an average length of stay of 25 days for their population.⁵ LTACH stays are paid a bundled rate by Medicare based on diagnosis.

Due to considerable variation in PAC use, with concerns that similar patients can be treated in different PAC settings,^6,7 the Centers for Medicare & Medicaid Services (CMS) recently introduced several major policy changes for HHAs, SNFs, and LTACHs (Table 1).¹ No major policy changes were made for IRFs.

For HHAs and SNFs, CMS implemented new payment models to better align payment with patients’ care needs rather than the provision of rehabilitation therapy.¹ For SNFs, the Patient
Driven Payment Model (PDPM) was implemented October 1, 2019, and for HHAs, the Patient-Driven Groupings Model (PDGM) was implemented January 1, 2020. These policies increase payment for patients who have nursing or ancillary care needs, such as IV medications, wound care, and respiratory support. For example, the per diem payment to SNFs is projected to increase 10% to 30% for patients needing dialysis, IV medications, wound care, and respiratory support, such as tracheostomy care.⁸ These policies also increase payment for patients with greater severity and complexity, such as patients with severe cognitive impairment and multimorbidity. Importantly, these policies pay HHAs and SNFs based on patients’ clinical needs and not solely based on the amount of rehabilitation therapy delivered, which could increase both the number and complexity of patients that SNFs accept.

To discourage LTACH use by patients who are unlikely to benefit from this level of care, CMS fully implemented the site-neutral payment policy on October 1, 2020 (although it is paused during the coronavirus disease 2019 [COVID-19] pandemic), which substantially decreased payment to LTACHs for patients who either did not have an ICU stay of 3 or more days preceding the transfer or did not receive prolonged mechanical ventilation in the LTACH for 96 or more hours.

Historically, PAC payment policy has not properly incentivized the appropriate amount of care to be delivered in the appropriate setting.⁹ The recent HHA, SNF, and LTACH policy changes not only shift the discharge of patients across PAC settings, but also change the amount and type of care that occurs at each PAC site (Table 2). The potential benefit of these new policies is that they will help to align the right level of PAC with patients’ needs by discouraging inappropriate use and unnecessary services. Under the new HHA and SNF payment models, initial media reports suggest a decline in therapy services has occurred, which could be beneficial if the therapy was excessive and not indicated.^4,10,11 Similarly, LTACHs are experiencing a large decline in admissions as fewer patients meet the new payment criteria.¹ As with all policy changes, the potential exists for unintended consequences. Because HHAs and SNFs are no longer incentivized to provide therapy, they might withhold the provision of needed rehabilitation therapy.¹⁰ Furthermore, because payments are based on patient coding by HHA and SNF providers under the new payment models, coding practices may change in order to optimize their payments. Indeed, the PDGM policy for HHAs includes a “behavioral adjustment” to account for anticipated changes in improved documentation by HHAs. Because LTACHs will be less likely to admit patients without prolonged mechanical ventilation or a qualifying ICU stay of 3 or more days, these patients might remain in the hospital for longer periods of time if they are too sick or their care needs are too complex for other PAC settings. Given these possible unintended consequences, the implications for hospital discharge patterns, PAC access, and quality of care will need to be closely monitored, as it is unclear how these PAC policy changes will impact patient care.

In terms of broader payment reform, the four PAC settings are still fragmented, with little effort to unify payment, regulation, and quality across the PAC continuum. As required by the Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014, we would encourage the adoption of a unified PAC payment system that spans the four settings, with payments based on patient characteristics and needs rather than site of service.¹² This type of reform would also harmonize regulation and quality measurement and reward payments across settings. Currently, CMS is standardizing patient assessment data and quality metrics across the four PAC settings. Given the COVID-19 pandemic, the transition to a unified PAC payment system is likely several years away.

For our patient who was transferred to an LTACH after referrals to SNFs were denied, PAC options now differ following these major PAC policy reforms, and SNF transfer would be an option. This is because SNFs will receive higher payment for providing respiratory support under the PDPM, and LTACHs will receive considerably lower reimbursement because the patient did not have a qualifying ICU stay or require prolonged mechanical ventilation. Furthermore, hospitals participating in accountable care organizations would achieve greater savings, given that LTACHs cost at least three times as much as SNFs for comparable diagnoses.

Instead of referring this patient to a LTACH, the care team (hospitalist, discharge navigator, and case manager) should inform and educate the patient about discharge options to SNFs for weaning from respiratory support. To help patients and caregivers choose a facility, the discharge planning team should provide data about the quality of SNFs (eg, CMS Star Ratings scores) instead of simply providing a list of names and locations.^13,14 Discharge planning should start as soon as possible to permit caregivers an opportunity to visit facilities and for the providers to coordinate the transfer as seamlessly as possible.

Recent major PAC policy changes will change where hospitals discharge medically complex patients and the services they will receive at these PAC settings. Historically, reduction in PAC use has been a key source for savings in alternative payment models that encourage value over volume, such as accountable care organizations and episode-based (“bundled”) payment models.¹⁵ We anticipate these PAC policy changes are a step in the right direction to further enable hospitals to achieve value by more closely aligning PAC incentives with patients’ needs.

A 23-year-old woman presented to the emergency department complaining of “feeling terrible” for the past week. She described subjective fevers, chills, nonproductive cough, myalgias, and nausea. Her symptoms worsened on the day of presentation, with drenching night sweats, worsening myalgias, and generalized fatigue. She was unable to tolerate oral intake due to persistent nausea and had one episode of emesis.

While the initial constellation of symptoms suggests a viral syndrome, its progression over a week raises concern for something more ominous. Of her relatively nonspecific symptoms, prominent myalgias accompanied by a febrile illness may be most helpful. Fever, myalgias, and nonproductive cough are typical of seasonal influenza, although the presence of nausea and vomiting is atypical in adults. (Though this patient presented for care prior to the coronavirus disease 2019 [COVID-19] pandemic, depending on the timing of this presentation, COVID-19 should be considered.) Acute viral myositis can complicate many viral illnesses, such as influenza, coxsackie, and Epstein-Barr virus infections. Other infectious causes of myositis include systemic bacterial infections, spirochete diseases, and other viral infections, including dengue fever. Myalgias can also be a prominent feature of noninfectious systemic inflammatory conditions, such as systemic lupus erythematosus, rheumatoid arthritis, polymyositis, and systemic vasculitis. Night sweats, while concerning, can be present in myriad conditions, and are not usually a discriminating symptom.

Her past medical history included depression, nephrolithiasis, frequent urinary tract infections, bladder spasms, and recurrent genital herpes simplex virus infection. Her medications included bupropion, microgestin, mirabegron, and valacyclovir. Her father had emphysema.

The patient was employed as a physical therapy assistant in a geriatric care center. Two weeks prior to presentation, she traveled from her home in North Carolina to visit a friend in Atlanta, Georgia. Shortly after the patient returned home, her friend in Atlanta became ill and was treated empirically for Legionella infection because of a recent outbreak in the area. One week prior to presentation, the patient and her boyfriend went on a day hike in the Smoky Mountains in North Carolina, but the patient did not recall any insect or tick bites. Her boyfriend had not been ill.

This history elucidates several potentially relevant medication and environmental exposures. Although bupropion can cause myalgias, neither it nor the other medications she is taking are likely to cause her constellation of symptoms. Her travel history to Atlanta suggests possible, though unconfirmed, exposure to Legionella pneumophila. Notably, she would have had to be exposed to the same source as her friend, since transmission of Legionella occurs via contaminated water and soil, not by human-to-human contact. Legionella infection typically causes a pneumonic process as described here, but her prominent myalgias would not be typical.

Her hike in the Smoky Mountains could have exposed her to several vector-borne diseases. Mosquito-borne dengue in North Carolina is extremely rare, but West Nile virus and eastern equine virus are found within that region. West Nile virus could cause a similar illness, although the cough and lack of neurologic symptoms would be unusual. Eastern equine virus can also cause similar symptoms but is quite rare.

Tick-borne illnesses that should be considered for this region include Lyme disease, Rocky Mountain spotted fever (RMSF), ehrlichiosis, and babesiosis. These tend to present with nonspecific symptoms, but myalgias and fever are consistent features. Lyme disease this close to tick exposure usually presents with the characteristic erythema migrans rash, present in 80% of cases, with or without an influenza-like illness. Approximately 80% of patients do not recall a tick bite, even though a tick must be attached for 36 to 48 hours to transmit the spirochete. RMSF often presents with fever and myalgias, with arthralgias and headache, which are lacking in this case. The common, characteristic rash of blanching erythematous macules that convert to petechiae, starting at the ankles and wrists and spreading to the trunk, is often absent at presentation, showing up at days 3 to 5 in most patients.

Ehrlichiosis presents with an influenza-like illness, but up to half of patients also have nausea and cough. It can also present with a macular and petechial rash in a minority of patients. Lastly, babesiosis presents with an influenza-like illness and less often with cough or nausea. At this juncture, RMSF and ehrlichiosis are possibilities given the hiking history and symptoms, although the absence of a rash points more to ehrlichiosis.

The patient did not smoke cigarettes but had used a JUUL^© vaporizer daily for the prior 2 years. Her last use was 1 week prior to admission. She used tetrahydrocannabinol (THC) pods purchased online in the vaporizer on a few occasions 1month prior but had not used THC since that time. She denied alcohol or other drug use.

Until recently, this important detail about vaping use would have been passed over without much consideration. Though reports of acute lung injury from vaping were published as early as 2017, it first came to national attention in August 2019 when the Centers for Disease Control and Prevention posted a Health Advisory about severe lung injury associated with e-cigarette use. Of note, this advisory and subsequent published case series outline that e-cigarette, or vaping, use-associated lung injury (EVALI) may present with more than just respiratory symptoms. Most patients have respiratory symptoms such as shortness of breath, cough, or pleurisy, but many have gastrointestinal symptoms which may include abdominal pain, nausea, vomiting, and diarrhea.¹ Constitutional symptoms, including fever, chills, or weight loss, may also predominate.² In some cases, the gastrointestinal symptoms precede the pulmonary symptoms. This patient’s symptoms warrant consideration of EVALI starting with a chest x-ray (CXR), which is usually abnormal in this disease.²

Physical examination revealed that the patient was alert, diaphoretic, and in mild respiratory distress. Temperature was 103.6 °F, blood pressure 129/75 mm Hg, pulse 130 beats per minute, respiratory rate 20 per minute, and oxygen saturation 97% while breathing ambient air. Cardiac examination revealed tachycardia without murmurs, rubs, or gallops. Lung exam revealed scattered rhonchi over the left posterior lower chest without egophony or dullness to percussion. Findings from abdominal, skin, neurologic, lymph node, and musculoskeletal exams were unremarkable.

Her fever, tachycardia, and respiratory distress point to a pulmonary process such as pneumonia or EVALI, even though she does not have definitive physical exam evidence of pneumonia. She presents with systemic inflammatory response syndrome without significant hypoxia and with borderline tachypnea, which could be related to sepsis or lactic acidosis from a systemic infection other than pneumonia. Her symptom complex could also be compatible with severe influenza infection. The absence of rash makes RMSF less likely.

Results of a complete blood count demonstrated a white blood cell count of 12,600/µL with 87% neutrophils. Results of a metabolic panel were normal, and a urine pregnancy test was negative. The electrocardiogram revealed sinus tachycardia without other abnormalities. A CXR showed no evidence of acute cardiopulmonary abnormalities.

Her lab studies lack thrombocytopenia, which is often found in ehrlichiosis and RMSF. Leukopenia is also absent, which can be seen in Lyme disease and ehrlichiosis. The mild leukocytosis could be consistent with pneumonia, influenza, and EVALI and is not discriminating. The normal CXR goes against pneumonia or EVALI; however, 9% of patients with EVALI in one case series had a normal CXR, while computed tomography (CT) of the chest demonstrated bilateral ground-glass opacities.³ Chest CT is indicated in this case given the poor correlation of the CXR findings and this patient’s pronounced respiratory symptoms.

CT of the chest with contrast did not show a pulmonary embolism but revealed diffuse ground-glass opacities, predominantly in the dependent lower lobes (Figure 1).

Acute conditions with diffuse ground-glass opacities include mycoplasma, Pneumocystis jiroveci and viral pneumonias, pulmonary hemorrhage and edema, acute interstitial pneumonia, eosinophilic lung diseases, and hypersensitivity pneumonitis. Diffuse ground-glass opacities are also seen in almost all patients with EVALI. Though less likely, RMSF, babesiosis, and ehrlichiosis are not ruled out by these chest CT findings, since these disease entities can sometimes cause pulmonary manifestations, including pneumonia, pulmonary edema, and acute respiratory distress syndrome (ARDS).⁴

In addition to Legionella and pneumococcal urinary antigen tests, respiratory viral panel, and blood cultures, it would be judicious to obtain HIV, C-reactive protein, and erythrocyte sedimentation rate (ESR) testing; these last two tests are often markedly elevated in EVALI. The utility of bronchoalveolar lavage (BAL) in suspected EVALI cases is not clearly defined, but should be considered in this case to ensure that infectious etiologies are not missed.² Because of her potential environmental exposures, serologic testing for RMSF and ehrlichiosis should be sent.

Given the overlap in signs and symptoms of EVALI with various, potentially life-threatening infections, she should be empirically treated with antibiotics to cover for community-acquired pneumonia. Adding or even substituting doxycycline for a macrolide antibiotic in this regimen should be considered given that it would treat both RMSF and ehrlichiosis pending further test results. Delay in treating RMSF is associated with worse outcomes. If she is presenting during influenza season, she should also be treated with a neuraminidase inhibitor while awaiting influenza test results. Though the pathophysiology of EVALI is not entirely known, it appears to be inflammatory in nature. Most presumed cases have responded to corticosteroids, with improvement in oxygenation.² Therefore, treatment with corticosteroids may be warranted to improve oxygenation while ruling out infectious processes.

The patient was admitted to the general medicine wards and started on ceftriaxone and azithromycin for empiric treatment of community-acquired pneumonia. On hospital day 2, a respiratory viral panel returned negative. Procalcitonin, HIV, and blood cultures all returned negative. An ESR was elevated at 86 mm/h. The patient continued to have daily fevers and developed erythematous, blanching macules on the neck, chest, back, and arms, which were noted to occur during febrile periods. Ceftriaxone and azithromycin were discontinued, and doxycycline was started. By hospital day 4, the patient’s oxygen saturation worsened to 86% on ambient air. She continued to have fevers and her cough worsened, with occasional blood-streaked sputum. The patient was transferred to the intensive care unit for closer monitoring.

On hospital day 5, she required intubation for worsening hypoxia. Bronchoscopy was performed, which revealed small mucosal crypts along the left mainstem bronchus. A small amount of bleeding after transbronchial biopsy of the left lower lobe was noted, which resolved with occlusion using the bronchoscope. BAL was performed, which revealed red, cloudy aspirate with 1,100 white blood cells (85% neutrophils) and 22,400 red blood cells. No bacteria were identified.

The patient has developed hypoxic respiratory failure despite appropriate antibiotics and negative cultures, increasing the likelihood of a noninfectious etiology. Her rash is not typical for RMSF, which usually starts as a macular or petechial rash at the ankles and wrists, and spreads centrally to the trunk. Rash is not typically associated with EVALI, and in this case, may represent miliaria caused by her fever.

The mucosal crypts seen on bronchoscopy are nonspecific, likely indicating inflammation from vaping. The BAL otherwise suggests diffuse alveolar hemorrhage (DAH), although sequential BAL aliquots are needed to confirm this diagnosis. DAH is usually caused by pulmonary capillaritis from vasculitis, Goodpasture disease, rheumatic diseases, or diffuse alveolar damage from toxins, infections, rheumatic diseases, or interstitial or organizing pneumonias. Diffuse alveolar damage is the pathologic finding of ARDS, which can be seen in severe cases of many of the conditions discussed, including EVALI, ehrlichiosis, babesiosis, sepsis, and community-acquired pneumonia.⁴

The BAL is most consistent with EVALI, which often shows elevated neutrophils. DAH due to vaping has also been reported.⁵ In patients with EVALI, varied pathologic findings of acute lung injury have been reported, including diffuse alveolar damage.⁶ At this point, laboratory evaluation for rheumatologic diseases and vasculitis should be obtained, and lung biopsy results reviewed. Given her clinical deterioration, treatment with intravenous corticosteroids for presumed EVALI is warranted.

Urine Legionella and Streptococcal pneumoniae antigen tests were negative. The patient was started on methylprednisolone 40 mg intravenously every 8 hours. Further testing included antinuclear antibodies, which was positive at 1:320, with a dense, fine speckled pattern. Perinuclear antineutrophilic cytoplasmic autoantibody, cytoplasmic antineutrophilic cytoplasmic autoantibody, myeloperoxidase, proteinase 3, double-stranded DNA, and glomerular basement membrane IgG were all negative. Transbronchial lung biopsy revealed severe acute lung injury consistent with diffuse alveolar damage. The pulmonary interstitium was mildly expanded by edema, with a moderate number of eosinophilic hyaline membranes. There were no eosinophils or evidence of hemorrhage, granulomas, or giant cells. These changes, within this clinical context, were diagnostic for EVALI.

The patient was intubated for 4 days and completed a course of empiric antibiotics as well as a 10-day course of prednisone. She was discharged on hospital day 17 on 2 L continuous oxygen via nasal cannula. Two days after discharge, she developed worsening dyspnea and chest pain and was readmitted with worsening ground-glass opacities, left upper lobe and right- sided pneumothoraces, and subcutaneous emphysema (Figure 2). She was treated with continuous oxygen to maintain oxygen saturation at 100% and eventually discharged home 3 days later on 3 L continuous oxygen. She attended pulmonary rehabilitation and was weaned off oxygen 2 months later, with marked improvement in aeration of both lungs (Figure 3). She continued to abstain from tobacco and THC products.

The first electronic cigarette (e-cigarette) device was developed in 2003 by a Chinese pharmacist and introduced to the American market in 2007.⁷ E-cigarettes produce an inhalable aerosol by heating a liquid containing a variety of chemicals, nicotine, and flavors, with or without other additives. Originally promoted as a safer nontobacco and cessation device by producers, e-cigarette sales grew at an annual rate of 115% between 2009 and 2012.⁸ E-cigarettes can also be used to deliver THC, the psychoactive component of cannabis.

Since the advent of e-cigarettes, their safety has been a topic of concern. In August 2019, the CDC announced 215 possible cases of severe pulmonary disease associated with the use of e-cigarette products that were reported by 25 state health departments.¹ By February 2020, EVALI had affected more than 2,800 patients hospitalized across the United States.⁹

The presenting symptoms of EVALI are varied and nonspecific. The largest EVALI case series, published by Layden et al in 2020, included 98 patients who had a median duration of 6 days of symptoms prior to presentation.³ Respiratory symptoms occurred in 97% of patients, including shortness of breath, any chest pain, pleuritic chest pain, cough, and hemoptysis.³ Presentations also included a variety of gastrointestinal (77%) and constitutional (100%) symptoms, which most commonly included nausea, vomiting, and fever.³ Additional case series have supported a specific pattern of presentation, most commonly including pleuritic chest pain, nonproductive cough, or shortness of breath occurring days to weeks prior to presentation. Associated fatigue, fever, and tachycardia may be present, as well as nausea, vomiting, diarrhea and abdominal pain, and in some cases, these have preceded respiratory symptoms.^3,10,11

The vital signs and physical examination, laboratory, and imaging results associated with EVALI are also fairly nonspecific. The most common reason for hospitalization in EVALI is hypoxia, which can progress to acute respiratory failure requiring supplemental oxygen or, as in this case, mechanical ventilation. The most common laboratory finding is leukocytosis greater than 11,000/µL, with more than 80% neutrophils and an ESR greater than 30 mm/hr. In the Layden et al case series, 83% of patients had an abnormal CXR. All patients who underwent CT scan of the chest had bilateral ground-glass opacities, often with subpleural sparing.³ A minority of patients were found to have a pneumothorax, generally a late finding.^3,12 Accordingly, the CDC now defines confirmed EVALI as use of e-cigarettes during the 90 days before symptom onset with the presence of pulmonary infiltrates (opacities on CXR or ground-glass opacities on chest CT), negative results on testing for all clinically indicated respiratory infections including respiratory viral panel and influenza PCR, and no alternative plausible diagnoses.¹³

The presumed etiology of EVALI is chemical exposure because no consistent infectious etiology has been identified.⁶ No consistent e-cigarette product, substance, or additive has been identified in all cases, nor has one product been directly linked to EVALI. However, the CDC recently announced that vitamin E acetate in vaping products appears to be associated with EVALI.⁹ In December 2019, Blount et al identified vitamin E acetate in BAL fluid samples from 48 of 51 EVALI patients.¹⁴ Additionally, while no other toxins were identified, 94% of samples contained THC or its metabolites or patients had reported vaping THC within 90 days preceding illness.¹⁴

The most effective treatment strategy for EVALI is still unknown. It is recommended to treat with empiric antibiotics for at least 48 hours (and antivirals during influenza season) if the history is unclear or if the patient is intubated or has severe hypoxemia.² If antibiotic and/or antiviral therapies do not lead to clinical improvement, corticosteroids should be added, as they lead to improved oxygenation in many patients.² Kalininskiy et al recommend initial administration of methylprednisolone 40 mg every 8 hours, with transition to oral prednisone to complete a 2-week course.² Given rates of rehospitalization (2.7%) and death (2%) in EVALI, the CDC advises that patients should be clinically stable for 24 to 48 hours prior to discharge; that follow-up visits should be arranged within 48 hours of discharge; and that cases of EVALI should be reported to the state and local health departments.¹⁵ As seen in the case presented here, with time and continued abstinence from e-cigarette use, the pulmonary effects of EVALI can improve, but long-term outcomes remain unclear. Clinicians must now consider EVALI in patients presenting with respiratory, constitutional, and gastrointestinal complaints when a history of e-cigarette use is present.

• EVALI presents most commonly with a combination of respiratory, gastrointestinal, and constitutional symptoms. including shortness of breath, cough, nausea, vomiting, and fever.
• When considering EVALI, evaluate and treat for potential infectious causes of disease first.
• Corticosteroids are the mainstay of therapy in EVALI, leading to improvement in oxygenation in many patients.
• Most of the reported cases of EVALI have occurred in patients who have vaped THC-containing products.

A 23-year-old woman presented to the emergency department complaining of “feeling terrible” for the past week. She described subjective fevers, chills, nonproductive cough, myalgias, and nausea. Her symptoms worsened on the day of presentation, with drenching night sweats, worsening myalgias, and generalized fatigue. She was unable to tolerate oral intake due to persistent nausea and had one episode of emesis.

While the initial constellation of symptoms suggests a viral syndrome, its progression over a week raises concern for something more ominous. Of her relatively nonspecific symptoms, prominent myalgias accompanied by a febrile illness may be most helpful. Fever, myalgias, and nonproductive cough are typical of seasonal influenza, although the presence of nausea and vomiting is atypical in adults. (Though this patient presented for care prior to the coronavirus disease 2019 [COVID-19] pandemic, depending on the timing of this presentation, COVID-19 should be considered.) Acute viral myositis can complicate many viral illnesses, such as influenza, coxsackie, and Epstein-Barr virus infections. Other infectious causes of myositis include systemic bacterial infections, spirochete diseases, and other viral infections, including dengue fever. Myalgias can also be a prominent feature of noninfectious systemic inflammatory conditions, such as systemic lupus erythematosus, rheumatoid arthritis, polymyositis, and systemic vasculitis. Night sweats, while concerning, can be present in myriad conditions, and are not usually a discriminating symptom.

Her past medical history included depression, nephrolithiasis, frequent urinary tract infections, bladder spasms, and recurrent genital herpes simplex virus infection. Her medications included bupropion, microgestin, mirabegron, and valacyclovir. Her father had emphysema.

The patient was employed as a physical therapy assistant in a geriatric care center. Two weeks prior to presentation, she traveled from her home in North Carolina to visit a friend in Atlanta, Georgia. Shortly after the patient returned home, her friend in Atlanta became ill and was treated empirically for Legionella infection because of a recent outbreak in the area. One week prior to presentation, the patient and her boyfriend went on a day hike in the Smoky Mountains in North Carolina, but the patient did not recall any insect or tick bites. Her boyfriend had not been ill.

This history elucidates several potentially relevant medication and environmental exposures. Although bupropion can cause myalgias, neither it nor the other medications she is taking are likely to cause her constellation of symptoms. Her travel history to Atlanta suggests possible, though unconfirmed, exposure to Legionella pneumophila. Notably, she would have had to be exposed to the same source as her friend, since transmission of Legionella occurs via contaminated water and soil, not by human-to-human contact. Legionella infection typically causes a pneumonic process as described here, but her prominent myalgias would not be typical.

Her hike in the Smoky Mountains could have exposed her to several vector-borne diseases. Mosquito-borne dengue in North Carolina is extremely rare, but West Nile virus and eastern equine virus are found within that region. West Nile virus could cause a similar illness, although the cough and lack of neurologic symptoms would be unusual. Eastern equine virus can also cause similar symptoms but is quite rare.

Tick-borne illnesses that should be considered for this region include Lyme disease, Rocky Mountain spotted fever (RMSF), ehrlichiosis, and babesiosis. These tend to present with nonspecific symptoms, but myalgias and fever are consistent features. Lyme disease this close to tick exposure usually presents with the characteristic erythema migrans rash, present in 80% of cases, with or without an influenza-like illness. Approximately 80% of patients do not recall a tick bite, even though a tick must be attached for 36 to 48 hours to transmit the spirochete. RMSF often presents with fever and myalgias, with arthralgias and headache, which are lacking in this case. The common, characteristic rash of blanching erythematous macules that convert to petechiae, starting at the ankles and wrists and spreading to the trunk, is often absent at presentation, showing up at days 3 to 5 in most patients.

Ehrlichiosis presents with an influenza-like illness, but up to half of patients also have nausea and cough. It can also present with a macular and petechial rash in a minority of patients. Lastly, babesiosis presents with an influenza-like illness and less often with cough or nausea. At this juncture, RMSF and ehrlichiosis are possibilities given the hiking history and symptoms, although the absence of a rash points more to ehrlichiosis.

The patient did not smoke cigarettes but had used a JUUL^© vaporizer daily for the prior 2 years. Her last use was 1 week prior to admission. She used tetrahydrocannabinol (THC) pods purchased online in the vaporizer on a few occasions 1month prior but had not used THC since that time. She denied alcohol or other drug use.

Until recently, this important detail about vaping use would have been passed over without much consideration. Though reports of acute lung injury from vaping were published as early as 2017, it first came to national attention in August 2019 when the Centers for Disease Control and Prevention posted a Health Advisory about severe lung injury associated with e-cigarette use. Of note, this advisory and subsequent published case series outline that e-cigarette, or vaping, use-associated lung injury (EVALI) may present with more than just respiratory symptoms. Most patients have respiratory symptoms such as shortness of breath, cough, or pleurisy, but many have gastrointestinal symptoms which may include abdominal pain, nausea, vomiting, and diarrhea.¹ Constitutional symptoms, including fever, chills, or weight loss, may also predominate.² In some cases, the gastrointestinal symptoms precede the pulmonary symptoms. This patient’s symptoms warrant consideration of EVALI starting with a chest x-ray (CXR), which is usually abnormal in this disease.²

Physical examination revealed that the patient was alert, diaphoretic, and in mild respiratory distress. Temperature was 103.6 °F, blood pressure 129/75 mm Hg, pulse 130 beats per minute, respiratory rate 20 per minute, and oxygen saturation 97% while breathing ambient air. Cardiac examination revealed tachycardia without murmurs, rubs, or gallops. Lung exam revealed scattered rhonchi over the left posterior lower chest without egophony or dullness to percussion. Findings from abdominal, skin, neurologic, lymph node, and musculoskeletal exams were unremarkable.

Her fever, tachycardia, and respiratory distress point to a pulmonary process such as pneumonia or EVALI, even though she does not have definitive physical exam evidence of pneumonia. She presents with systemic inflammatory response syndrome without significant hypoxia and with borderline tachypnea, which could be related to sepsis or lactic acidosis from a systemic infection other than pneumonia. Her symptom complex could also be compatible with severe influenza infection. The absence of rash makes RMSF less likely.

Results of a complete blood count demonstrated a white blood cell count of 12,600/µL with 87% neutrophils. Results of a metabolic panel were normal, and a urine pregnancy test was negative. The electrocardiogram revealed sinus tachycardia without other abnormalities. A CXR showed no evidence of acute cardiopulmonary abnormalities.

Her lab studies lack thrombocytopenia, which is often found in ehrlichiosis and RMSF. Leukopenia is also absent, which can be seen in Lyme disease and ehrlichiosis. The mild leukocytosis could be consistent with pneumonia, influenza, and EVALI and is not discriminating. The normal CXR goes against pneumonia or EVALI; however, 9% of patients with EVALI in one case series had a normal CXR, while computed tomography (CT) of the chest demonstrated bilateral ground-glass opacities.³ Chest CT is indicated in this case given the poor correlation of the CXR findings and this patient’s pronounced respiratory symptoms.

CT of the chest with contrast did not show a pulmonary embolism but revealed diffuse ground-glass opacities, predominantly in the dependent lower lobes (Figure 1).

Acute conditions with diffuse ground-glass opacities include mycoplasma, Pneumocystis jiroveci and viral pneumonias, pulmonary hemorrhage and edema, acute interstitial pneumonia, eosinophilic lung diseases, and hypersensitivity pneumonitis. Diffuse ground-glass opacities are also seen in almost all patients with EVALI. Though less likely, RMSF, babesiosis, and ehrlichiosis are not ruled out by these chest CT findings, since these disease entities can sometimes cause pulmonary manifestations, including pneumonia, pulmonary edema, and acute respiratory distress syndrome (ARDS).⁴

In addition to Legionella and pneumococcal urinary antigen tests, respiratory viral panel, and blood cultures, it would be judicious to obtain HIV, C-reactive protein, and erythrocyte sedimentation rate (ESR) testing; these last two tests are often markedly elevated in EVALI. The utility of bronchoalveolar lavage (BAL) in suspected EVALI cases is not clearly defined, but should be considered in this case to ensure that infectious etiologies are not missed.² Because of her potential environmental exposures, serologic testing for RMSF and ehrlichiosis should be sent.

Given the overlap in signs and symptoms of EVALI with various, potentially life-threatening infections, she should be empirically treated with antibiotics to cover for community-acquired pneumonia. Adding or even substituting doxycycline for a macrolide antibiotic in this regimen should be considered given that it would treat both RMSF and ehrlichiosis pending further test results. Delay in treating RMSF is associated with worse outcomes. If she is presenting during influenza season, she should also be treated with a neuraminidase inhibitor while awaiting influenza test results. Though the pathophysiology of EVALI is not entirely known, it appears to be inflammatory in nature. Most presumed cases have responded to corticosteroids, with improvement in oxygenation.² Therefore, treatment with corticosteroids may be warranted to improve oxygenation while ruling out infectious processes.

The patient was admitted to the general medicine wards and started on ceftriaxone and azithromycin for empiric treatment of community-acquired pneumonia. On hospital day 2, a respiratory viral panel returned negative. Procalcitonin, HIV, and blood cultures all returned negative. An ESR was elevated at 86 mm/h. The patient continued to have daily fevers and developed erythematous, blanching macules on the neck, chest, back, and arms, which were noted to occur during febrile periods. Ceftriaxone and azithromycin were discontinued, and doxycycline was started. By hospital day 4, the patient’s oxygen saturation worsened to 86% on ambient air. She continued to have fevers and her cough worsened, with occasional blood-streaked sputum. The patient was transferred to the intensive care unit for closer monitoring.

On hospital day 5, she required intubation for worsening hypoxia. Bronchoscopy was performed, which revealed small mucosal crypts along the left mainstem bronchus. A small amount of bleeding after transbronchial biopsy of the left lower lobe was noted, which resolved with occlusion using the bronchoscope. BAL was performed, which revealed red, cloudy aspirate with 1,100 white blood cells (85% neutrophils) and 22,400 red blood cells. No bacteria were identified.

The patient has developed hypoxic respiratory failure despite appropriate antibiotics and negative cultures, increasing the likelihood of a noninfectious etiology. Her rash is not typical for RMSF, which usually starts as a macular or petechial rash at the ankles and wrists, and spreads centrally to the trunk. Rash is not typically associated with EVALI, and in this case, may represent miliaria caused by her fever.

The mucosal crypts seen on bronchoscopy are nonspecific, likely indicating inflammation from vaping. The BAL otherwise suggests diffuse alveolar hemorrhage (DAH), although sequential BAL aliquots are needed to confirm this diagnosis. DAH is usually caused by pulmonary capillaritis from vasculitis, Goodpasture disease, rheumatic diseases, or diffuse alveolar damage from toxins, infections, rheumatic diseases, or interstitial or organizing pneumonias. Diffuse alveolar damage is the pathologic finding of ARDS, which can be seen in severe cases of many of the conditions discussed, including EVALI, ehrlichiosis, babesiosis, sepsis, and community-acquired pneumonia.⁴

The BAL is most consistent with EVALI, which often shows elevated neutrophils. DAH due to vaping has also been reported.⁵ In patients with EVALI, varied pathologic findings of acute lung injury have been reported, including diffuse alveolar damage.⁶ At this point, laboratory evaluation for rheumatologic diseases and vasculitis should be obtained, and lung biopsy results reviewed. Given her clinical deterioration, treatment with intravenous corticosteroids for presumed EVALI is warranted.

Urine Legionella and Streptococcal pneumoniae antigen tests were negative. The patient was started on methylprednisolone 40 mg intravenously every 8 hours. Further testing included antinuclear antibodies, which was positive at 1:320, with a dense, fine speckled pattern. Perinuclear antineutrophilic cytoplasmic autoantibody, cytoplasmic antineutrophilic cytoplasmic autoantibody, myeloperoxidase, proteinase 3, double-stranded DNA, and glomerular basement membrane IgG were all negative. Transbronchial lung biopsy revealed severe acute lung injury consistent with diffuse alveolar damage. The pulmonary interstitium was mildly expanded by edema, with a moderate number of eosinophilic hyaline membranes. There were no eosinophils or evidence of hemorrhage, granulomas, or giant cells. These changes, within this clinical context, were diagnostic for EVALI.

The patient was intubated for 4 days and completed a course of empiric antibiotics as well as a 10-day course of prednisone. She was discharged on hospital day 17 on 2 L continuous oxygen via nasal cannula. Two days after discharge, she developed worsening dyspnea and chest pain and was readmitted with worsening ground-glass opacities, left upper lobe and right- sided pneumothoraces, and subcutaneous emphysema (Figure 2). She was treated with continuous oxygen to maintain oxygen saturation at 100% and eventually discharged home 3 days later on 3 L continuous oxygen. She attended pulmonary rehabilitation and was weaned off oxygen 2 months later, with marked improvement in aeration of both lungs (Figure 3). She continued to abstain from tobacco and THC products.

The first electronic cigarette (e-cigarette) device was developed in 2003 by a Chinese pharmacist and introduced to the American market in 2007.⁷ E-cigarettes produce an inhalable aerosol by heating a liquid containing a variety of chemicals, nicotine, and flavors, with or without other additives. Originally promoted as a safer nontobacco and cessation device by producers, e-cigarette sales grew at an annual rate of 115% between 2009 and 2012.⁸ E-cigarettes can also be used to deliver THC, the psychoactive component of cannabis.

Since the advent of e-cigarettes, their safety has been a topic of concern. In August 2019, the CDC announced 215 possible cases of severe pulmonary disease associated with the use of e-cigarette products that were reported by 25 state health departments.¹ By February 2020, EVALI had affected more than 2,800 patients hospitalized across the United States.⁹

The presenting symptoms of EVALI are varied and nonspecific. The largest EVALI case series, published by Layden et al in 2020, included 98 patients who had a median duration of 6 days of symptoms prior to presentation.³ Respiratory symptoms occurred in 97% of patients, including shortness of breath, any chest pain, pleuritic chest pain, cough, and hemoptysis.³ Presentations also included a variety of gastrointestinal (77%) and constitutional (100%) symptoms, which most commonly included nausea, vomiting, and fever.³ Additional case series have supported a specific pattern of presentation, most commonly including pleuritic chest pain, nonproductive cough, or shortness of breath occurring days to weeks prior to presentation. Associated fatigue, fever, and tachycardia may be present, as well as nausea, vomiting, diarrhea and abdominal pain, and in some cases, these have preceded respiratory symptoms.^3,10,11

The vital signs and physical examination, laboratory, and imaging results associated with EVALI are also fairly nonspecific. The most common reason for hospitalization in EVALI is hypoxia, which can progress to acute respiratory failure requiring supplemental oxygen or, as in this case, mechanical ventilation. The most common laboratory finding is leukocytosis greater than 11,000/µL, with more than 80% neutrophils and an ESR greater than 30 mm/hr. In the Layden et al case series, 83% of patients had an abnormal CXR. All patients who underwent CT scan of the chest had bilateral ground-glass opacities, often with subpleural sparing.³ A minority of patients were found to have a pneumothorax, generally a late finding.^3,12 Accordingly, the CDC now defines confirmed EVALI as use of e-cigarettes during the 90 days before symptom onset with the presence of pulmonary infiltrates (opacities on CXR or ground-glass opacities on chest CT), negative results on testing for all clinically indicated respiratory infections including respiratory viral panel and influenza PCR, and no alternative plausible diagnoses.¹³

The presumed etiology of EVALI is chemical exposure because no consistent infectious etiology has been identified.⁶ No consistent e-cigarette product, substance, or additive has been identified in all cases, nor has one product been directly linked to EVALI. However, the CDC recently announced that vitamin E acetate in vaping products appears to be associated with EVALI.⁹ In December 2019, Blount et al identified vitamin E acetate in BAL fluid samples from 48 of 51 EVALI patients.¹⁴ Additionally, while no other toxins were identified, 94% of samples contained THC or its metabolites or patients had reported vaping THC within 90 days preceding illness.¹⁴

The most effective treatment strategy for EVALI is still unknown. It is recommended to treat with empiric antibiotics for at least 48 hours (and antivirals during influenza season) if the history is unclear or if the patient is intubated or has severe hypoxemia.² If antibiotic and/or antiviral therapies do not lead to clinical improvement, corticosteroids should be added, as they lead to improved oxygenation in many patients.² Kalininskiy et al recommend initial administration of methylprednisolone 40 mg every 8 hours, with transition to oral prednisone to complete a 2-week course.² Given rates of rehospitalization (2.7%) and death (2%) in EVALI, the CDC advises that patients should be clinically stable for 24 to 48 hours prior to discharge; that follow-up visits should be arranged within 48 hours of discharge; and that cases of EVALI should be reported to the state and local health departments.¹⁵ As seen in the case presented here, with time and continued abstinence from e-cigarette use, the pulmonary effects of EVALI can improve, but long-term outcomes remain unclear. Clinicians must now consider EVALI in patients presenting with respiratory, constitutional, and gastrointestinal complaints when a history of e-cigarette use is present.

• EVALI presents most commonly with a combination of respiratory, gastrointestinal, and constitutional symptoms. including shortness of breath, cough, nausea, vomiting, and fever.
• When considering EVALI, evaluate and treat for potential infectious causes of disease first.
• Corticosteroids are the mainstay of therapy in EVALI, leading to improvement in oxygenation in many patients.
• Most of the reported cases of EVALI have occurred in patients who have vaped THC-containing products.

A 23-year-old woman presented to the emergency department complaining of “feeling terrible” for the past week. She described subjective fevers, chills, nonproductive cough, myalgias, and nausea. Her symptoms worsened on the day of presentation, with drenching night sweats, worsening myalgias, and generalized fatigue. She was unable to tolerate oral intake due to persistent nausea and had one episode of emesis.

While the initial constellation of symptoms suggests a viral syndrome, its progression over a week raises concern for something more ominous. Of her relatively nonspecific symptoms, prominent myalgias accompanied by a febrile illness may be most helpful. Fever, myalgias, and nonproductive cough are typical of seasonal influenza, although the presence of nausea and vomiting is atypical in adults. (Though this patient presented for care prior to the coronavirus disease 2019 [COVID-19] pandemic, depending on the timing of this presentation, COVID-19 should be considered.) Acute viral myositis can complicate many viral illnesses, such as influenza, coxsackie, and Epstein-Barr virus infections. Other infectious causes of myositis include systemic bacterial infections, spirochete diseases, and other viral infections, including dengue fever. Myalgias can also be a prominent feature of noninfectious systemic inflammatory conditions, such as systemic lupus erythematosus, rheumatoid arthritis, polymyositis, and systemic vasculitis. Night sweats, while concerning, can be present in myriad conditions, and are not usually a discriminating symptom.

Her past medical history included depression, nephrolithiasis, frequent urinary tract infections, bladder spasms, and recurrent genital herpes simplex virus infection. Her medications included bupropion, microgestin, mirabegron, and valacyclovir. Her father had emphysema.

The patient was employed as a physical therapy assistant in a geriatric care center. Two weeks prior to presentation, she traveled from her home in North Carolina to visit a friend in Atlanta, Georgia. Shortly after the patient returned home, her friend in Atlanta became ill and was treated empirically for Legionella infection because of a recent outbreak in the area. One week prior to presentation, the patient and her boyfriend went on a day hike in the Smoky Mountains in North Carolina, but the patient did not recall any insect or tick bites. Her boyfriend had not been ill.

This history elucidates several potentially relevant medication and environmental exposures. Although bupropion can cause myalgias, neither it nor the other medications she is taking are likely to cause her constellation of symptoms. Her travel history to Atlanta suggests possible, though unconfirmed, exposure to Legionella pneumophila. Notably, she would have had to be exposed to the same source as her friend, since transmission of Legionella occurs via contaminated water and soil, not by human-to-human contact. Legionella infection typically causes a pneumonic process as described here, but her prominent myalgias would not be typical.

Her hike in the Smoky Mountains could have exposed her to several vector-borne diseases. Mosquito-borne dengue in North Carolina is extremely rare, but West Nile virus and eastern equine virus are found within that region. West Nile virus could cause a similar illness, although the cough and lack of neurologic symptoms would be unusual. Eastern equine virus can also cause similar symptoms but is quite rare.

Tick-borne illnesses that should be considered for this region include Lyme disease, Rocky Mountain spotted fever (RMSF), ehrlichiosis, and babesiosis. These tend to present with nonspecific symptoms, but myalgias and fever are consistent features. Lyme disease this close to tick exposure usually presents with the characteristic erythema migrans rash, present in 80% of cases, with or without an influenza-like illness. Approximately 80% of patients do not recall a tick bite, even though a tick must be attached for 36 to 48 hours to transmit the spirochete. RMSF often presents with fever and myalgias, with arthralgias and headache, which are lacking in this case. The common, characteristic rash of blanching erythematous macules that convert to petechiae, starting at the ankles and wrists and spreading to the trunk, is often absent at presentation, showing up at days 3 to 5 in most patients.

Ehrlichiosis presents with an influenza-like illness, but up to half of patients also have nausea and cough. It can also present with a macular and petechial rash in a minority of patients. Lastly, babesiosis presents with an influenza-like illness and less often with cough or nausea. At this juncture, RMSF and ehrlichiosis are possibilities given the hiking history and symptoms, although the absence of a rash points more to ehrlichiosis.

The patient did not smoke cigarettes but had used a JUUL^© vaporizer daily for the prior 2 years. Her last use was 1 week prior to admission. She used tetrahydrocannabinol (THC) pods purchased online in the vaporizer on a few occasions 1month prior but had not used THC since that time. She denied alcohol or other drug use.

Until recently, this important detail about vaping use would have been passed over without much consideration. Though reports of acute lung injury from vaping were published as early as 2017, it first came to national attention in August 2019 when the Centers for Disease Control and Prevention posted a Health Advisory about severe lung injury associated with e-cigarette use. Of note, this advisory and subsequent published case series outline that e-cigarette, or vaping, use-associated lung injury (EVALI) may present with more than just respiratory symptoms. Most patients have respiratory symptoms such as shortness of breath, cough, or pleurisy, but many have gastrointestinal symptoms which may include abdominal pain, nausea, vomiting, and diarrhea.¹ Constitutional symptoms, including fever, chills, or weight loss, may also predominate.² In some cases, the gastrointestinal symptoms precede the pulmonary symptoms. This patient’s symptoms warrant consideration of EVALI starting with a chest x-ray (CXR), which is usually abnormal in this disease.²

Physical examination revealed that the patient was alert, diaphoretic, and in mild respiratory distress. Temperature was 103.6 °F, blood pressure 129/75 mm Hg, pulse 130 beats per minute, respiratory rate 20 per minute, and oxygen saturation 97% while breathing ambient air. Cardiac examination revealed tachycardia without murmurs, rubs, or gallops. Lung exam revealed scattered rhonchi over the left posterior lower chest without egophony or dullness to percussion. Findings from abdominal, skin, neurologic, lymph node, and musculoskeletal exams were unremarkable.

Her fever, tachycardia, and respiratory distress point to a pulmonary process such as pneumonia or EVALI, even though she does not have definitive physical exam evidence of pneumonia. She presents with systemic inflammatory response syndrome without significant hypoxia and with borderline tachypnea, which could be related to sepsis or lactic acidosis from a systemic infection other than pneumonia. Her symptom complex could also be compatible with severe influenza infection. The absence of rash makes RMSF less likely.

Results of a complete blood count demonstrated a white blood cell count of 12,600/µL with 87% neutrophils. Results of a metabolic panel were normal, and a urine pregnancy test was negative. The electrocardiogram revealed sinus tachycardia without other abnormalities. A CXR showed no evidence of acute cardiopulmonary abnormalities.

Her lab studies lack thrombocytopenia, which is often found in ehrlichiosis and RMSF. Leukopenia is also absent, which can be seen in Lyme disease and ehrlichiosis. The mild leukocytosis could be consistent with pneumonia, influenza, and EVALI and is not discriminating. The normal CXR goes against pneumonia or EVALI; however, 9% of patients with EVALI in one case series had a normal CXR, while computed tomography (CT) of the chest demonstrated bilateral ground-glass opacities.³ Chest CT is indicated in this case given the poor correlation of the CXR findings and this patient’s pronounced respiratory symptoms.

CT of the chest with contrast did not show a pulmonary embolism but revealed diffuse ground-glass opacities, predominantly in the dependent lower lobes (Figure 1).

Acute conditions with diffuse ground-glass opacities include mycoplasma, Pneumocystis jiroveci and viral pneumonias, pulmonary hemorrhage and edema, acute interstitial pneumonia, eosinophilic lung diseases, and hypersensitivity pneumonitis. Diffuse ground-glass opacities are also seen in almost all patients with EVALI. Though less likely, RMSF, babesiosis, and ehrlichiosis are not ruled out by these chest CT findings, since these disease entities can sometimes cause pulmonary manifestations, including pneumonia, pulmonary edema, and acute respiratory distress syndrome (ARDS).⁴

In addition to Legionella and pneumococcal urinary antigen tests, respiratory viral panel, and blood cultures, it would be judicious to obtain HIV, C-reactive protein, and erythrocyte sedimentation rate (ESR) testing; these last two tests are often markedly elevated in EVALI. The utility of bronchoalveolar lavage (BAL) in suspected EVALI cases is not clearly defined, but should be considered in this case to ensure that infectious etiologies are not missed.² Because of her potential environmental exposures, serologic testing for RMSF and ehrlichiosis should be sent.

Given the overlap in signs and symptoms of EVALI with various, potentially life-threatening infections, she should be empirically treated with antibiotics to cover for community-acquired pneumonia. Adding or even substituting doxycycline for a macrolide antibiotic in this regimen should be considered given that it would treat both RMSF and ehrlichiosis pending further test results. Delay in treating RMSF is associated with worse outcomes. If she is presenting during influenza season, she should also be treated with a neuraminidase inhibitor while awaiting influenza test results. Though the pathophysiology of EVALI is not entirely known, it appears to be inflammatory in nature. Most presumed cases have responded to corticosteroids, with improvement in oxygenation.² Therefore, treatment with corticosteroids may be warranted to improve oxygenation while ruling out infectious processes.

The patient was admitted to the general medicine wards and started on ceftriaxone and azithromycin for empiric treatment of community-acquired pneumonia. On hospital day 2, a respiratory viral panel returned negative. Procalcitonin, HIV, and blood cultures all returned negative. An ESR was elevated at 86 mm/h. The patient continued to have daily fevers and developed erythematous, blanching macules on the neck, chest, back, and arms, which were noted to occur during febrile periods. Ceftriaxone and azithromycin were discontinued, and doxycycline was started. By hospital day 4, the patient’s oxygen saturation worsened to 86% on ambient air. She continued to have fevers and her cough worsened, with occasional blood-streaked sputum. The patient was transferred to the intensive care unit for closer monitoring.

On hospital day 5, she required intubation for worsening hypoxia. Bronchoscopy was performed, which revealed small mucosal crypts along the left mainstem bronchus. A small amount of bleeding after transbronchial biopsy of the left lower lobe was noted, which resolved with occlusion using the bronchoscope. BAL was performed, which revealed red, cloudy aspirate with 1,100 white blood cells (85% neutrophils) and 22,400 red blood cells. No bacteria were identified.

The patient has developed hypoxic respiratory failure despite appropriate antibiotics and negative cultures, increasing the likelihood of a noninfectious etiology. Her rash is not typical for RMSF, which usually starts as a macular or petechial rash at the ankles and wrists, and spreads centrally to the trunk. Rash is not typically associated with EVALI, and in this case, may represent miliaria caused by her fever.

The mucosal crypts seen on bronchoscopy are nonspecific, likely indicating inflammation from vaping. The BAL otherwise suggests diffuse alveolar hemorrhage (DAH), although sequential BAL aliquots are needed to confirm this diagnosis. DAH is usually caused by pulmonary capillaritis from vasculitis, Goodpasture disease, rheumatic diseases, or diffuse alveolar damage from toxins, infections, rheumatic diseases, or interstitial or organizing pneumonias. Diffuse alveolar damage is the pathologic finding of ARDS, which can be seen in severe cases of many of the conditions discussed, including EVALI, ehrlichiosis, babesiosis, sepsis, and community-acquired pneumonia.⁴

The BAL is most consistent with EVALI, which often shows elevated neutrophils. DAH due to vaping has also been reported.⁵ In patients with EVALI, varied pathologic findings of acute lung injury have been reported, including diffuse alveolar damage.⁶ At this point, laboratory evaluation for rheumatologic diseases and vasculitis should be obtained, and lung biopsy results reviewed. Given her clinical deterioration, treatment with intravenous corticosteroids for presumed EVALI is warranted.

Urine Legionella and Streptococcal pneumoniae antigen tests were negative. The patient was started on methylprednisolone 40 mg intravenously every 8 hours. Further testing included antinuclear antibodies, which was positive at 1:320, with a dense, fine speckled pattern. Perinuclear antineutrophilic cytoplasmic autoantibody, cytoplasmic antineutrophilic cytoplasmic autoantibody, myeloperoxidase, proteinase 3, double-stranded DNA, and glomerular basement membrane IgG were all negative. Transbronchial lung biopsy revealed severe acute lung injury consistent with diffuse alveolar damage. The pulmonary interstitium was mildly expanded by edema, with a moderate number of eosinophilic hyaline membranes. There were no eosinophils or evidence of hemorrhage, granulomas, or giant cells. These changes, within this clinical context, were diagnostic for EVALI.

The patient was intubated for 4 days and completed a course of empiric antibiotics as well as a 10-day course of prednisone. She was discharged on hospital day 17 on 2 L continuous oxygen via nasal cannula. Two days after discharge, she developed worsening dyspnea and chest pain and was readmitted with worsening ground-glass opacities, left upper lobe and right- sided pneumothoraces, and subcutaneous emphysema (Figure 2). She was treated with continuous oxygen to maintain oxygen saturation at 100% and eventually discharged home 3 days later on 3 L continuous oxygen. She attended pulmonary rehabilitation and was weaned off oxygen 2 months later, with marked improvement in aeration of both lungs (Figure 3). She continued to abstain from tobacco and THC products.

The first electronic cigarette (e-cigarette) device was developed in 2003 by a Chinese pharmacist and introduced to the American market in 2007.⁷ E-cigarettes produce an inhalable aerosol by heating a liquid containing a variety of chemicals, nicotine, and flavors, with or without other additives. Originally promoted as a safer nontobacco and cessation device by producers, e-cigarette sales grew at an annual rate of 115% between 2009 and 2012.⁸ E-cigarettes can also be used to deliver THC, the psychoactive component of cannabis.

Since the advent of e-cigarettes, their safety has been a topic of concern. In August 2019, the CDC announced 215 possible cases of severe pulmonary disease associated with the use of e-cigarette products that were reported by 25 state health departments.¹ By February 2020, EVALI had affected more than 2,800 patients hospitalized across the United States.⁹

The presenting symptoms of EVALI are varied and nonspecific. The largest EVALI case series, published by Layden et al in 2020, included 98 patients who had a median duration of 6 days of symptoms prior to presentation.³ Respiratory symptoms occurred in 97% of patients, including shortness of breath, any chest pain, pleuritic chest pain, cough, and hemoptysis.³ Presentations also included a variety of gastrointestinal (77%) and constitutional (100%) symptoms, which most commonly included nausea, vomiting, and fever.³ Additional case series have supported a specific pattern of presentation, most commonly including pleuritic chest pain, nonproductive cough, or shortness of breath occurring days to weeks prior to presentation. Associated fatigue, fever, and tachycardia may be present, as well as nausea, vomiting, diarrhea and abdominal pain, and in some cases, these have preceded respiratory symptoms.^3,10,11

The vital signs and physical examination, laboratory, and imaging results associated with EVALI are also fairly nonspecific. The most common reason for hospitalization in EVALI is hypoxia, which can progress to acute respiratory failure requiring supplemental oxygen or, as in this case, mechanical ventilation. The most common laboratory finding is leukocytosis greater than 11,000/µL, with more than 80% neutrophils and an ESR greater than 30 mm/hr. In the Layden et al case series, 83% of patients had an abnormal CXR. All patients who underwent CT scan of the chest had bilateral ground-glass opacities, often with subpleural sparing.³ A minority of patients were found to have a pneumothorax, generally a late finding.^3,12 Accordingly, the CDC now defines confirmed EVALI as use of e-cigarettes during the 90 days before symptom onset with the presence of pulmonary infiltrates (opacities on CXR or ground-glass opacities on chest CT), negative results on testing for all clinically indicated respiratory infections including respiratory viral panel and influenza PCR, and no alternative plausible diagnoses.¹³

The presumed etiology of EVALI is chemical exposure because no consistent infectious etiology has been identified.⁶ No consistent e-cigarette product, substance, or additive has been identified in all cases, nor has one product been directly linked to EVALI. However, the CDC recently announced that vitamin E acetate in vaping products appears to be associated with EVALI.⁹ In December 2019, Blount et al identified vitamin E acetate in BAL fluid samples from 48 of 51 EVALI patients.¹⁴ Additionally, while no other toxins were identified, 94% of samples contained THC or its metabolites or patients had reported vaping THC within 90 days preceding illness.¹⁴

The most effective treatment strategy for EVALI is still unknown. It is recommended to treat with empiric antibiotics for at least 48 hours (and antivirals during influenza season) if the history is unclear or if the patient is intubated or has severe hypoxemia.² If antibiotic and/or antiviral therapies do not lead to clinical improvement, corticosteroids should be added, as they lead to improved oxygenation in many patients.² Kalininskiy et al recommend initial administration of methylprednisolone 40 mg every 8 hours, with transition to oral prednisone to complete a 2-week course.² Given rates of rehospitalization (2.7%) and death (2%) in EVALI, the CDC advises that patients should be clinically stable for 24 to 48 hours prior to discharge; that follow-up visits should be arranged within 48 hours of discharge; and that cases of EVALI should be reported to the state and local health departments.¹⁵ As seen in the case presented here, with time and continued abstinence from e-cigarette use, the pulmonary effects of EVALI can improve, but long-term outcomes remain unclear. Clinicians must now consider EVALI in patients presenting with respiratory, constitutional, and gastrointestinal complaints when a history of e-cigarette use is present.

• EVALI presents most commonly with a combination of respiratory, gastrointestinal, and constitutional symptoms. including shortness of breath, cough, nausea, vomiting, and fever.
• When considering EVALI, evaluate and treat for potential infectious causes of disease first.
• Corticosteroids are the mainstay of therapy in EVALI, leading to improvement in oxygenation in many patients.
• Most of the reported cases of EVALI have occurred in patients who have vaped THC-containing products.

Potential catastrophic surges in coronavirus disease 2019 (COVID-19) are leading to more patients requiring intensive care unit beds than are available, prompting hospitals to prepare to activate crisis standards of care (CSC).^1,2 These guidelines manage the sobering process of determining which gravely ill patients will have access to limited ventilators, critical care specialists, and other essential hospital personnel. As a member of the CSC triage team at Brigham and Women’s Hospital, Boston, Massachusetts, during the initial surge,¹ I was taught how to follow procedures that assign each patient a priority score that ranged from 1 to 8, with lower scores representing higher priority. Scoring decisions were largely based on current status of organ systems and major medical illnesses (predictive of short-term and longer-term survival, respectively), consistent with the objective of maximizing lives and life-years saved.^1,3-7 Other parameters included improving the priority score of a pregnant woman with a viable fetus and breaking ties in favor of younger patients who had not lived through life’s major stages.^4,7 One issue that elicited sharp disagreement among my colleagues was whether healthcare providers (HCPs; eg, physicians, nurses) should be treated any differently than other individuals.

I believe that HCPs should receive treatment priority during a pandemic because the community has a special obligation to those workers willing to risk serious illness by providing care to potentially infected patients.

The most common argument for prioritizing HCPs has been made on utilitarian grounds: save individuals who can save others.^3,4,6 Such an approach is not founded on the claim that HCPs have higher intrinsic worth, but is based on the instrumental value of HCPs to keep others alive.^4,6 An abiding concern for human life demands systems to ensure individuals with clinical expertise are protected so that they can use their skills to maximize the number of lives saved. A similar case has been made to justify prioritizing HCPs for early access to vaccines during a pandemic.⁵ To underscore these issues, imagine a scenario in which, because of serious illness among HCPs, there were not enough workers with requisite expertise to care for the rest of the community in which a virus was rapidly spreading. Prioritizing HCPs could mitigate this sequence of events by preventing them from becoming infected through early access to vaccinations or promoting their recovery from the illness, which might allow them to return to work caring for others.

Although the utilitarian argument has merit, my primary reason for advocating the prioritization of HCPs reflects a different ethical framework that emphasizes the reciprocal obligations between HCPs and the community. Obligations of physicians have been framed in terms of the commitments made to their self-chosen profession and the putative social contract that has been constructed with the community.^8-10 These principles are well articulated in the American Medical Association’s (AMA’s) Code of Medical Ethics, which states, “Because of their commitment to care for the sick and injured, individual physicians have an obligation to provide urgent medical care during disasters…even in the face of greater than usual risks to their own safety, health, or life.”^10,11 Although the AMA qualified its position by indicating that this obligation is not unconditional, it still formulated exceptions within the overarching structure of professional duty, allowing physicians to “balance immediate benefits to individual patients with ability to care for patients in the future.”^11,12

If one accepts that HCPs have a professional obligation to take care of sick members of the community, even in perilous situations, what, if any, reciprocal obligation does the community have to its HCPs? Reciprocity is a fundamental ethical principle,¹³ serving as a foundation for the Golden Rule, which is a component of almost every ethical tradition.¹⁴ At its core, reciprocity asks us to treat other people as we would want to be treated. It requires endeavoring to take the perspective of others. Within this framework, a strategy for generating a just policy about treatment prioritization is to develop it under the assumption of not knowing which role one would end up playing in a situation. It is critical that if the positions of the individuals involved were reversed, the same rules and obligations would be accepted as fair.¹³ I suggest that if members of the community put themselves in the shoes of HCPs who are willing to risk exposure to a potentially deadly virus, they would acknowledge the legitimate expectation of HCPs to receive prioritized care if they became ill from the infection.

In most cases, reciprocity is not construed as requiring an identical exchange, but a fair one in which, for instance, sacrifice is returned in kind. Obligations can be viewed as debts that we either owe or are entitled to receive.¹⁵ In the current context, reciprocal obligations are derived from the relationship between HCPs and the community in which they serve. HCPs have a special set of obligations to carry out their work with a high degree of professionalism. If circumstances demand they take on substantial risk for their community, the community, in turn, has a special obligation to take care of them.

To highlight this perspective, imagine HCPs who become ill with COVID-19 and make claims for treatment priority despite having been unwilling to work with patients who are sick with COVID-19. We would consider such claims to be unjust because our moral intuition suggests that individuals are owed a debt for the actual risks they have taken, not for the potential ones they have avoided. A corollary of this view is that HCPs who have demonstrated a willingness to risk their lives contracting COVID-19 have a legitimate claim for prioritization.

Acknowledgment of the community’s special obligation to HCPs does not negate competing claims for prioritization, such as trying to save the most lives or accounting for a patient’s pregnancy status and stage of life. Rather, there is a need for CSC guidelines to also include recognition of the special obligations owed HCPs by improving their priority score in the calculus used to triage care. Operationalizing the process would need to be worked out. One possibility would be for HCPs directly caring for patients ill from COVID-19 to have their priority score improve by 2 points, and HCPs directly caring for patients without known disease (but who could still be infectious) to benefit by 1 point. At a minimum, recognition of the risks taken should serve as a tiebreaker in favor of these workers.

If we acknowledge that during a pandemic, the community has a special obligation to HCPs because of the risks they are taking to serve others, by the same logic, this commitment should be extended to any personnel linked to the healthcare system (eg, employees in environmental services) or frontline workers providing essential services (eg, grocery store workers) who are taking similar risks that involve exposure to potentially infected individuals. Conversely, HCPs who are working exclusively from home via telemedicine should not receive treatment priority. An approach that extends treatment prioritization to other relevant workers mitigates concerns raised about prioritizing scarce critical care resources to an already advantaged class of individuals (ie, HCPs) as well as the negative optics of a committee of “deciders” in a hospital who are privileging care to their own members.¹²

Reciprocity, a critical component of our notion of justice, should be incorporated into CSC guidelines. The community’s reciprocity to HCPs and frontline workers needs to be commensurate with the sacrifice made by these groups. Although public demonstrations of gratitude may be much appreciated, such displays alone are not adequate for honoring the community’s special obligations. If, during a pandemic, HCPs or frontline workers deliver direct care or services to members of the community, despite serious risk to their own lives, the community has a reciprocal obligation to these individuals to prioritize their access to critical care. HCPs and frontline workers should be prioritized not because their lives have higher intrinsic worth or solely as a reflection of their instrumental value to the community, but out of recognition of the special debt owed them. This is not an unconditional obligation, but one that should be built into the complex, multifaceted decision-making process^4,6,16 underlying the allocation of scarce medical resources in a pandemic.

The author deeply appreciates the thoughtful comments on the essay from William Snyder, PhD, Melissa Frumin, MD, Brittany McFeeley, BS, Lise Bliss, MBA, and especially Seth Gales, MD, and remains grateful for the guidance and support he received early in his academic career from his first mentors, Carol Gilligan, PhD, and Michael Walzer, PhD.

Potential catastrophic surges in coronavirus disease 2019 (COVID-19) are leading to more patients requiring intensive care unit beds than are available, prompting hospitals to prepare to activate crisis standards of care (CSC).^1,2 These guidelines manage the sobering process of determining which gravely ill patients will have access to limited ventilators, critical care specialists, and other essential hospital personnel. As a member of the CSC triage team at Brigham and Women’s Hospital, Boston, Massachusetts, during the initial surge,¹ I was taught how to follow procedures that assign each patient a priority score that ranged from 1 to 8, with lower scores representing higher priority. Scoring decisions were largely based on current status of organ systems and major medical illnesses (predictive of short-term and longer-term survival, respectively), consistent with the objective of maximizing lives and life-years saved.^1,3-7 Other parameters included improving the priority score of a pregnant woman with a viable fetus and breaking ties in favor of younger patients who had not lived through life’s major stages.^4,7 One issue that elicited sharp disagreement among my colleagues was whether healthcare providers (HCPs; eg, physicians, nurses) should be treated any differently than other individuals.

I believe that HCPs should receive treatment priority during a pandemic because the community has a special obligation to those workers willing to risk serious illness by providing care to potentially infected patients.

The most common argument for prioritizing HCPs has been made on utilitarian grounds: save individuals who can save others.^3,4,6 Such an approach is not founded on the claim that HCPs have higher intrinsic worth, but is based on the instrumental value of HCPs to keep others alive.^4,6 An abiding concern for human life demands systems to ensure individuals with clinical expertise are protected so that they can use their skills to maximize the number of lives saved. A similar case has been made to justify prioritizing HCPs for early access to vaccines during a pandemic.⁵ To underscore these issues, imagine a scenario in which, because of serious illness among HCPs, there were not enough workers with requisite expertise to care for the rest of the community in which a virus was rapidly spreading. Prioritizing HCPs could mitigate this sequence of events by preventing them from becoming infected through early access to vaccinations or promoting their recovery from the illness, which might allow them to return to work caring for others.

Although the utilitarian argument has merit, my primary reason for advocating the prioritization of HCPs reflects a different ethical framework that emphasizes the reciprocal obligations between HCPs and the community. Obligations of physicians have been framed in terms of the commitments made to their self-chosen profession and the putative social contract that has been constructed with the community.^8-10 These principles are well articulated in the American Medical Association’s (AMA’s) Code of Medical Ethics, which states, “Because of their commitment to care for the sick and injured, individual physicians have an obligation to provide urgent medical care during disasters…even in the face of greater than usual risks to their own safety, health, or life.”^10,11 Although the AMA qualified its position by indicating that this obligation is not unconditional, it still formulated exceptions within the overarching structure of professional duty, allowing physicians to “balance immediate benefits to individual patients with ability to care for patients in the future.”^11,12

If one accepts that HCPs have a professional obligation to take care of sick members of the community, even in perilous situations, what, if any, reciprocal obligation does the community have to its HCPs? Reciprocity is a fundamental ethical principle,¹³ serving as a foundation for the Golden Rule, which is a component of almost every ethical tradition.¹⁴ At its core, reciprocity asks us to treat other people as we would want to be treated. It requires endeavoring to take the perspective of others. Within this framework, a strategy for generating a just policy about treatment prioritization is to develop it under the assumption of not knowing which role one would end up playing in a situation. It is critical that if the positions of the individuals involved were reversed, the same rules and obligations would be accepted as fair.¹³ I suggest that if members of the community put themselves in the shoes of HCPs who are willing to risk exposure to a potentially deadly virus, they would acknowledge the legitimate expectation of HCPs to receive prioritized care if they became ill from the infection.

In most cases, reciprocity is not construed as requiring an identical exchange, but a fair one in which, for instance, sacrifice is returned in kind. Obligations can be viewed as debts that we either owe or are entitled to receive.¹⁵ In the current context, reciprocal obligations are derived from the relationship between HCPs and the community in which they serve. HCPs have a special set of obligations to carry out their work with a high degree of professionalism. If circumstances demand they take on substantial risk for their community, the community, in turn, has a special obligation to take care of them.

To highlight this perspective, imagine HCPs who become ill with COVID-19 and make claims for treatment priority despite having been unwilling to work with patients who are sick with COVID-19. We would consider such claims to be unjust because our moral intuition suggests that individuals are owed a debt for the actual risks they have taken, not for the potential ones they have avoided. A corollary of this view is that HCPs who have demonstrated a willingness to risk their lives contracting COVID-19 have a legitimate claim for prioritization.

Acknowledgment of the community’s special obligation to HCPs does not negate competing claims for prioritization, such as trying to save the most lives or accounting for a patient’s pregnancy status and stage of life. Rather, there is a need for CSC guidelines to also include recognition of the special obligations owed HCPs by improving their priority score in the calculus used to triage care. Operationalizing the process would need to be worked out. One possibility would be for HCPs directly caring for patients ill from COVID-19 to have their priority score improve by 2 points, and HCPs directly caring for patients without known disease (but who could still be infectious) to benefit by 1 point. At a minimum, recognition of the risks taken should serve as a tiebreaker in favor of these workers.

If we acknowledge that during a pandemic, the community has a special obligation to HCPs because of the risks they are taking to serve others, by the same logic, this commitment should be extended to any personnel linked to the healthcare system (eg, employees in environmental services) or frontline workers providing essential services (eg, grocery store workers) who are taking similar risks that involve exposure to potentially infected individuals. Conversely, HCPs who are working exclusively from home via telemedicine should not receive treatment priority. An approach that extends treatment prioritization to other relevant workers mitigates concerns raised about prioritizing scarce critical care resources to an already advantaged class of individuals (ie, HCPs) as well as the negative optics of a committee of “deciders” in a hospital who are privileging care to their own members.¹²

Reciprocity, a critical component of our notion of justice, should be incorporated into CSC guidelines. The community’s reciprocity to HCPs and frontline workers needs to be commensurate with the sacrifice made by these groups. Although public demonstrations of gratitude may be much appreciated, such displays alone are not adequate for honoring the community’s special obligations. If, during a pandemic, HCPs or frontline workers deliver direct care or services to members of the community, despite serious risk to their own lives, the community has a reciprocal obligation to these individuals to prioritize their access to critical care. HCPs and frontline workers should be prioritized not because their lives have higher intrinsic worth or solely as a reflection of their instrumental value to the community, but out of recognition of the special debt owed them. This is not an unconditional obligation, but one that should be built into the complex, multifaceted decision-making process^4,6,16 underlying the allocation of scarce medical resources in a pandemic.

The author deeply appreciates the thoughtful comments on the essay from William Snyder, PhD, Melissa Frumin, MD, Brittany McFeeley, BS, Lise Bliss, MBA, and especially Seth Gales, MD, and remains grateful for the guidance and support he received early in his academic career from his first mentors, Carol Gilligan, PhD, and Michael Walzer, PhD.

Potential catastrophic surges in coronavirus disease 2019 (COVID-19) are leading to more patients requiring intensive care unit beds than are available, prompting hospitals to prepare to activate crisis standards of care (CSC).^1,2 These guidelines manage the sobering process of determining which gravely ill patients will have access to limited ventilators, critical care specialists, and other essential hospital personnel. As a member of the CSC triage team at Brigham and Women’s Hospital, Boston, Massachusetts, during the initial surge,¹ I was taught how to follow procedures that assign each patient a priority score that ranged from 1 to 8, with lower scores representing higher priority. Scoring decisions were largely based on current status of organ systems and major medical illnesses (predictive of short-term and longer-term survival, respectively), consistent with the objective of maximizing lives and life-years saved.^1,3-7 Other parameters included improving the priority score of a pregnant woman with a viable fetus and breaking ties in favor of younger patients who had not lived through life’s major stages.^4,7 One issue that elicited sharp disagreement among my colleagues was whether healthcare providers (HCPs; eg, physicians, nurses) should be treated any differently than other individuals.

I believe that HCPs should receive treatment priority during a pandemic because the community has a special obligation to those workers willing to risk serious illness by providing care to potentially infected patients.

The most common argument for prioritizing HCPs has been made on utilitarian grounds: save individuals who can save others.^3,4,6 Such an approach is not founded on the claim that HCPs have higher intrinsic worth, but is based on the instrumental value of HCPs to keep others alive.^4,6 An abiding concern for human life demands systems to ensure individuals with clinical expertise are protected so that they can use their skills to maximize the number of lives saved. A similar case has been made to justify prioritizing HCPs for early access to vaccines during a pandemic.⁵ To underscore these issues, imagine a scenario in which, because of serious illness among HCPs, there were not enough workers with requisite expertise to care for the rest of the community in which a virus was rapidly spreading. Prioritizing HCPs could mitigate this sequence of events by preventing them from becoming infected through early access to vaccinations or promoting their recovery from the illness, which might allow them to return to work caring for others.

Although the utilitarian argument has merit, my primary reason for advocating the prioritization of HCPs reflects a different ethical framework that emphasizes the reciprocal obligations between HCPs and the community. Obligations of physicians have been framed in terms of the commitments made to their self-chosen profession and the putative social contract that has been constructed with the community.^8-10 These principles are well articulated in the American Medical Association’s (AMA’s) Code of Medical Ethics, which states, “Because of their commitment to care for the sick and injured, individual physicians have an obligation to provide urgent medical care during disasters…even in the face of greater than usual risks to their own safety, health, or life.”^10,11 Although the AMA qualified its position by indicating that this obligation is not unconditional, it still formulated exceptions within the overarching structure of professional duty, allowing physicians to “balance immediate benefits to individual patients with ability to care for patients in the future.”^11,12

If one accepts that HCPs have a professional obligation to take care of sick members of the community, even in perilous situations, what, if any, reciprocal obligation does the community have to its HCPs? Reciprocity is a fundamental ethical principle,¹³ serving as a foundation for the Golden Rule, which is a component of almost every ethical tradition.¹⁴ At its core, reciprocity asks us to treat other people as we would want to be treated. It requires endeavoring to take the perspective of others. Within this framework, a strategy for generating a just policy about treatment prioritization is to develop it under the assumption of not knowing which role one would end up playing in a situation. It is critical that if the positions of the individuals involved were reversed, the same rules and obligations would be accepted as fair.¹³ I suggest that if members of the community put themselves in the shoes of HCPs who are willing to risk exposure to a potentially deadly virus, they would acknowledge the legitimate expectation of HCPs to receive prioritized care if they became ill from the infection.

In most cases, reciprocity is not construed as requiring an identical exchange, but a fair one in which, for instance, sacrifice is returned in kind. Obligations can be viewed as debts that we either owe or are entitled to receive.¹⁵ In the current context, reciprocal obligations are derived from the relationship between HCPs and the community in which they serve. HCPs have a special set of obligations to carry out their work with a high degree of professionalism. If circumstances demand they take on substantial risk for their community, the community, in turn, has a special obligation to take care of them.

To highlight this perspective, imagine HCPs who become ill with COVID-19 and make claims for treatment priority despite having been unwilling to work with patients who are sick with COVID-19. We would consider such claims to be unjust because our moral intuition suggests that individuals are owed a debt for the actual risks they have taken, not for the potential ones they have avoided. A corollary of this view is that HCPs who have demonstrated a willingness to risk their lives contracting COVID-19 have a legitimate claim for prioritization.

Acknowledgment of the community’s special obligation to HCPs does not negate competing claims for prioritization, such as trying to save the most lives or accounting for a patient’s pregnancy status and stage of life. Rather, there is a need for CSC guidelines to also include recognition of the special obligations owed HCPs by improving their priority score in the calculus used to triage care. Operationalizing the process would need to be worked out. One possibility would be for HCPs directly caring for patients ill from COVID-19 to have their priority score improve by 2 points, and HCPs directly caring for patients without known disease (but who could still be infectious) to benefit by 1 point. At a minimum, recognition of the risks taken should serve as a tiebreaker in favor of these workers.

If we acknowledge that during a pandemic, the community has a special obligation to HCPs because of the risks they are taking to serve others, by the same logic, this commitment should be extended to any personnel linked to the healthcare system (eg, employees in environmental services) or frontline workers providing essential services (eg, grocery store workers) who are taking similar risks that involve exposure to potentially infected individuals. Conversely, HCPs who are working exclusively from home via telemedicine should not receive treatment priority. An approach that extends treatment prioritization to other relevant workers mitigates concerns raised about prioritizing scarce critical care resources to an already advantaged class of individuals (ie, HCPs) as well as the negative optics of a committee of “deciders” in a hospital who are privileging care to their own members.¹²

Reciprocity, a critical component of our notion of justice, should be incorporated into CSC guidelines. The community’s reciprocity to HCPs and frontline workers needs to be commensurate with the sacrifice made by these groups. Although public demonstrations of gratitude may be much appreciated, such displays alone are not adequate for honoring the community’s special obligations. If, during a pandemic, HCPs or frontline workers deliver direct care or services to members of the community, despite serious risk to their own lives, the community has a reciprocal obligation to these individuals to prioritize their access to critical care. HCPs and frontline workers should be prioritized not because their lives have higher intrinsic worth or solely as a reflection of their instrumental value to the community, but out of recognition of the special debt owed them. This is not an unconditional obligation, but one that should be built into the complex, multifaceted decision-making process^4,6,16 underlying the allocation of scarce medical resources in a pandemic.

The author deeply appreciates the thoughtful comments on the essay from William Snyder, PhD, Melissa Frumin, MD, Brittany McFeeley, BS, Lise Bliss, MBA, and especially Seth Gales, MD, and remains grateful for the guidance and support he received early in his academic career from his first mentors, Carol Gilligan, PhD, and Michael Walzer, PhD.

The impact of the coronavirus disease 2019 (COVID-19) pandemic has been far reaching and devastating. As the pandemic reaches its 1-year mark, there have been more cases and deaths than most of us can comprehend: nearly 28 million cases and 497,000 deaths in the United States¹ and more than 111 million cases and 2.4 million deaths globally.² Frontline healthcare workers (HCWs) have struggled to provide compassionate care in the face of heavy workloads and risks to themselves and their loved ones. Sadly, more than 1,700 US HCWs have died from COVID-19.³ The pandemic has also taken a heavy emotional and psychological toll: HCWs have died by suicide, and others are leaving the profession in which they invested so much and formerly loved. Caring for ill colleagues and dying patients whose family members cannot visit has been particularly difficult. It is, therefore, understandable that some HCWs have called for their prioritization if it becomes necessary to implement crisis standards of care. Although Daffner’s⁴ reciprocity argument—HCWs should receive priority because of the risks that they have voluntarily accepted—has some appeal, it disregards several important considerations. First, it fails to consider the changing dynamics of viral transmission during the pandemic or alternative ways in which the duty of reciprocity may be fulfilled that do not involve prioritizing HCWs over others. Second, this position is both over- and underinclusive in ways that make it difficult to implement. Third, and most important, the inordinate attention to the prioritization of HCWs ignores the issues the pandemic raises regarding racism and inequity.

Although the reciprocity argument has some conceptual merit, there are several different ways that the duty of reciprocity can be fulfilled. One fundamental obligation of government agencies and healthcare systems is providing a safe work environment, including adequate personal protective equipment (PPE) and physical distancing. Before we understood the extent of the pandemic, modes of transmission, and effective preventative measures, hospital transmission was significant. For example, a single-center case series at Zhongan Hospital of Wuhan University, China, from January 1, 2020, to January 28, 2020, found that 29% (40 of 138) of hospitalized patients with COVID-19 were health professionals who were presumed to have been infected by patients.⁵ There were also significant shortages of PPE, and a number of frontline HCWs reported being dismissed for calling attention to unsafe conditions. Although professionals have an obligation to expose themselves to risk, they are not obligated to expose themselves to inordinate risk. Prioritizing HCWs in ventilator triage may have been justified during the initial surge.

The use of surgical masks by all employees and patients has substantially reduced hospital transmission. A study at Duke Health, Raleigh, North Carolina, of HCWs who tested positive for SARS-CoV-2 between March 15, 2020, and June 6, 2020, found 22% of cases were healthcare acquired, 38% were community acquired, and 40% were of unknown acquisition route. Of the healthcare-acquired cases, 30% were thought to be secondary to direct patient care and 70% to exposure to another worker. The cumulative incidence rate of healthcare-acquired infections among workers decreased significantly 1 week after universal masking was implemented on March 31, 2020. The cumulative incidence rates of community-acquired cases and those with unknown acquisition routes continued to mirror incidence rates in the community.⁶ There is substantially less justification for prioritizing HCWs during the current phase of the pandemic; reciprocity does not justify granting HCWs infected via community spread greater priority than non-HCWs similarly infected.

There are other means of reciprocating that do not involve prioritization. COVID-19 has exacted an immense toll on the mental well-being of frontline HCWs. They should be provided robust, comprehensive, and accessible mental health services. Additionally, reciprocity can be expressed by providing alternative housing options for HCWs who are concerned about infecting their family members, especially family members at higher risk of morbidity or mortality from COVID-19. Many HCWs have also died from COVID-19^3; providing life insurance would recognize the sacrifice of HCWs and support their survivors. None of these interventions would require prioritizing HCWs over others.

As Daffner⁴ acknowledges, the category of “healthcare provider” is both over- and underinclusive. Healthcare providers are exposed to variable risks. Some physicians, for example, are no longer involved in direct patient care. It is unclear how triage teams will identify frontline HCWs or validate claims to being a frontline HCW, especially for individuals not employed by the hospital at which they are seeking care. Hence, triage protocols prioritizing healthcare providers are likely to be substantially overinclusive, which raises significant issues of fairness.

Moreover, the category “healthcare provider” is also underinclusive. Many essential, nonclinical hospital employees expose themselves to risk, including custodial and food service staff. As Daffner⁴ recognizes, there are also many other occupations outside of healthcare in which individuals voluntarily expose themselves to risks for the benefit of others, including police officers, firefighters, and clerks in grocery stores. We would add that workers in the food-supply system, transportation, and education face similar risks.⁷ Identifying the types of jobs that should confer priority and validating an individual’s employment also makes implementation difficult and risks injustice.

The COVID-19 pandemic and the murder of Black people by police have brought substantial attention to racism and racial inequities in the United States. We must, however, move from merely acknowledging existing inequities to dismantling structures that perpetuate them. The prioritization of HCWs may further privilege those who already have substantial advantages. This is especially true for physicians. For example, although state and federal laws pose limitations, physicians have historically extended one another professional courtesy by providing free or discounted services. Furthermore, HCWs and their family members are more likely to receive VIP treatment. For instance, when taken to the emergency department, children of physicians are less likely to have medical students and residents involved in their care and more likely to see attending physicians and consultants.⁸

In contrast, other categories of essential workers do not have such advantages. These workers are more likely to be members of marginalized racial and ethnic minority groups, have substantially lower wages, have less access to PPE, and work in more crowded conditions, and are less likely to have paid sick leave compared with HCWs.⁷ These workers are also more likely to lack access to quality healthcare. In fact, many safety net hospitals that provide care to marginalized communities have faced significant financial hardships as a result of the pandemic, and without additional support, some may close. Prioritizing HCWs will likely widen the gaps in health, economic, and social status among these groups.

With respect to allocation criteria, Black, Latinx, and Native American communities have more severe morbidity and mortality from COVID-19 as a result of racism and its interaction with other social determinants of health. Members of marginalized communities of color have a higher likelihood of becoming infected with COVID-19, a higher prevalence of comorbidities, and less access to treatment.⁷ Before her untimely death, Dr Susan Moore, a Black family physician, painfully described the racism to which she was subjected while being treated for COVID-19.⁹ The economic devastation caused by the pandemic, including unemployment, evictions, and food insecurity, compounds the impact of social determinants of health and disproportionately affects minority communities. Purely race- and ethnicity-based approaches to allocation to redress these inequities have potential limitations and obstacles, such as omission of other social determinants of health and legal challenges.⁷ While currently proposed for allocation of medications or vaccines, alternatives include using the Centers for Disease Control and Prevention’s Social Vulnerability Index⁸ or the Area Deprivation Index¹⁰ as a priority criterion. Most importantly, healthcare systems should more broadly demonstrate themselves trustworthy and assure that marginalized communities of color have access to quality healthcare services.

The United States has failed to adequately control the COVID-19 pandemic, and increasing numbers of admissions and staffing shortages have renewed concerns that hospitals will need to implement crisis standards of care. Daffner⁴ argues that healthcare providers should be prioritized in the allocation of critical care based on reciprocity. In the current phase of the pandemic, HCWs are more likely to be infected by one another or in the community than by patients. There are also other ways that hospitals can discharge this duty that do not require prioritizing HCWs over patients. The category of HCW is both over- and underinclusive, and Daffner⁴ has not shown that prioritization can be implemented fairly. Finally, inordinate attention has been paid to this topic. Much more attention should be focused on how to redress the ways in which the pandemic has exacerbated existing racial and ethnic inequities.

The impact of the coronavirus disease 2019 (COVID-19) pandemic has been far reaching and devastating. As the pandemic reaches its 1-year mark, there have been more cases and deaths than most of us can comprehend: nearly 28 million cases and 497,000 deaths in the United States¹ and more than 111 million cases and 2.4 million deaths globally.² Frontline healthcare workers (HCWs) have struggled to provide compassionate care in the face of heavy workloads and risks to themselves and their loved ones. Sadly, more than 1,700 US HCWs have died from COVID-19.³ The pandemic has also taken a heavy emotional and psychological toll: HCWs have died by suicide, and others are leaving the profession in which they invested so much and formerly loved. Caring for ill colleagues and dying patients whose family members cannot visit has been particularly difficult. It is, therefore, understandable that some HCWs have called for their prioritization if it becomes necessary to implement crisis standards of care. Although Daffner’s⁴ reciprocity argument—HCWs should receive priority because of the risks that they have voluntarily accepted—has some appeal, it disregards several important considerations. First, it fails to consider the changing dynamics of viral transmission during the pandemic or alternative ways in which the duty of reciprocity may be fulfilled that do not involve prioritizing HCWs over others. Second, this position is both over- and underinclusive in ways that make it difficult to implement. Third, and most important, the inordinate attention to the prioritization of HCWs ignores the issues the pandemic raises regarding racism and inequity.

Although the reciprocity argument has some conceptual merit, there are several different ways that the duty of reciprocity can be fulfilled. One fundamental obligation of government agencies and healthcare systems is providing a safe work environment, including adequate personal protective equipment (PPE) and physical distancing. Before we understood the extent of the pandemic, modes of transmission, and effective preventative measures, hospital transmission was significant. For example, a single-center case series at Zhongan Hospital of Wuhan University, China, from January 1, 2020, to January 28, 2020, found that 29% (40 of 138) of hospitalized patients with COVID-19 were health professionals who were presumed to have been infected by patients.⁵ There were also significant shortages of PPE, and a number of frontline HCWs reported being dismissed for calling attention to unsafe conditions. Although professionals have an obligation to expose themselves to risk, they are not obligated to expose themselves to inordinate risk. Prioritizing HCWs in ventilator triage may have been justified during the initial surge.

The use of surgical masks by all employees and patients has substantially reduced hospital transmission. A study at Duke Health, Raleigh, North Carolina, of HCWs who tested positive for SARS-CoV-2 between March 15, 2020, and June 6, 2020, found 22% of cases were healthcare acquired, 38% were community acquired, and 40% were of unknown acquisition route. Of the healthcare-acquired cases, 30% were thought to be secondary to direct patient care and 70% to exposure to another worker. The cumulative incidence rate of healthcare-acquired infections among workers decreased significantly 1 week after universal masking was implemented on March 31, 2020. The cumulative incidence rates of community-acquired cases and those with unknown acquisition routes continued to mirror incidence rates in the community.⁶ There is substantially less justification for prioritizing HCWs during the current phase of the pandemic; reciprocity does not justify granting HCWs infected via community spread greater priority than non-HCWs similarly infected.

There are other means of reciprocating that do not involve prioritization. COVID-19 has exacted an immense toll on the mental well-being of frontline HCWs. They should be provided robust, comprehensive, and accessible mental health services. Additionally, reciprocity can be expressed by providing alternative housing options for HCWs who are concerned about infecting their family members, especially family members at higher risk of morbidity or mortality from COVID-19. Many HCWs have also died from COVID-19^3; providing life insurance would recognize the sacrifice of HCWs and support their survivors. None of these interventions would require prioritizing HCWs over others.

As Daffner⁴ acknowledges, the category of “healthcare provider” is both over- and underinclusive. Healthcare providers are exposed to variable risks. Some physicians, for example, are no longer involved in direct patient care. It is unclear how triage teams will identify frontline HCWs or validate claims to being a frontline HCW, especially for individuals not employed by the hospital at which they are seeking care. Hence, triage protocols prioritizing healthcare providers are likely to be substantially overinclusive, which raises significant issues of fairness.

Moreover, the category “healthcare provider” is also underinclusive. Many essential, nonclinical hospital employees expose themselves to risk, including custodial and food service staff. As Daffner⁴ recognizes, there are also many other occupations outside of healthcare in which individuals voluntarily expose themselves to risks for the benefit of others, including police officers, firefighters, and clerks in grocery stores. We would add that workers in the food-supply system, transportation, and education face similar risks.⁷ Identifying the types of jobs that should confer priority and validating an individual’s employment also makes implementation difficult and risks injustice.

The COVID-19 pandemic and the murder of Black people by police have brought substantial attention to racism and racial inequities in the United States. We must, however, move from merely acknowledging existing inequities to dismantling structures that perpetuate them. The prioritization of HCWs may further privilege those who already have substantial advantages. This is especially true for physicians. For example, although state and federal laws pose limitations, physicians have historically extended one another professional courtesy by providing free or discounted services. Furthermore, HCWs and their family members are more likely to receive VIP treatment. For instance, when taken to the emergency department, children of physicians are less likely to have medical students and residents involved in their care and more likely to see attending physicians and consultants.⁸

In contrast, other categories of essential workers do not have such advantages. These workers are more likely to be members of marginalized racial and ethnic minority groups, have substantially lower wages, have less access to PPE, and work in more crowded conditions, and are less likely to have paid sick leave compared with HCWs.⁷ These workers are also more likely to lack access to quality healthcare. In fact, many safety net hospitals that provide care to marginalized communities have faced significant financial hardships as a result of the pandemic, and without additional support, some may close. Prioritizing HCWs will likely widen the gaps in health, economic, and social status among these groups.

With respect to allocation criteria, Black, Latinx, and Native American communities have more severe morbidity and mortality from COVID-19 as a result of racism and its interaction with other social determinants of health. Members of marginalized communities of color have a higher likelihood of becoming infected with COVID-19, a higher prevalence of comorbidities, and less access to treatment.⁷ Before her untimely death, Dr Susan Moore, a Black family physician, painfully described the racism to which she was subjected while being treated for COVID-19.⁹ The economic devastation caused by the pandemic, including unemployment, evictions, and food insecurity, compounds the impact of social determinants of health and disproportionately affects minority communities. Purely race- and ethnicity-based approaches to allocation to redress these inequities have potential limitations and obstacles, such as omission of other social determinants of health and legal challenges.⁷ While currently proposed for allocation of medications or vaccines, alternatives include using the Centers for Disease Control and Prevention’s Social Vulnerability Index⁸ or the Area Deprivation Index¹⁰ as a priority criterion. Most importantly, healthcare systems should more broadly demonstrate themselves trustworthy and assure that marginalized communities of color have access to quality healthcare services.

The United States has failed to adequately control the COVID-19 pandemic, and increasing numbers of admissions and staffing shortages have renewed concerns that hospitals will need to implement crisis standards of care. Daffner⁴ argues that healthcare providers should be prioritized in the allocation of critical care based on reciprocity. In the current phase of the pandemic, HCWs are more likely to be infected by one another or in the community than by patients. There are also other ways that hospitals can discharge this duty that do not require prioritizing HCWs over patients. The category of HCW is both over- and underinclusive, and Daffner⁴ has not shown that prioritization can be implemented fairly. Finally, inordinate attention has been paid to this topic. Much more attention should be focused on how to redress the ways in which the pandemic has exacerbated existing racial and ethnic inequities.

The impact of the coronavirus disease 2019 (COVID-19) pandemic has been far reaching and devastating. As the pandemic reaches its 1-year mark, there have been more cases and deaths than most of us can comprehend: nearly 28 million cases and 497,000 deaths in the United States¹ and more than 111 million cases and 2.4 million deaths globally.² Frontline healthcare workers (HCWs) have struggled to provide compassionate care in the face of heavy workloads and risks to themselves and their loved ones. Sadly, more than 1,700 US HCWs have died from COVID-19.³ The pandemic has also taken a heavy emotional and psychological toll: HCWs have died by suicide, and others are leaving the profession in which they invested so much and formerly loved. Caring for ill colleagues and dying patients whose family members cannot visit has been particularly difficult. It is, therefore, understandable that some HCWs have called for their prioritization if it becomes necessary to implement crisis standards of care. Although Daffner’s⁴ reciprocity argument—HCWs should receive priority because of the risks that they have voluntarily accepted—has some appeal, it disregards several important considerations. First, it fails to consider the changing dynamics of viral transmission during the pandemic or alternative ways in which the duty of reciprocity may be fulfilled that do not involve prioritizing HCWs over others. Second, this position is both over- and underinclusive in ways that make it difficult to implement. Third, and most important, the inordinate attention to the prioritization of HCWs ignores the issues the pandemic raises regarding racism and inequity.

Although the reciprocity argument has some conceptual merit, there are several different ways that the duty of reciprocity can be fulfilled. One fundamental obligation of government agencies and healthcare systems is providing a safe work environment, including adequate personal protective equipment (PPE) and physical distancing. Before we understood the extent of the pandemic, modes of transmission, and effective preventative measures, hospital transmission was significant. For example, a single-center case series at Zhongan Hospital of Wuhan University, China, from January 1, 2020, to January 28, 2020, found that 29% (40 of 138) of hospitalized patients with COVID-19 were health professionals who were presumed to have been infected by patients.⁵ There were also significant shortages of PPE, and a number of frontline HCWs reported being dismissed for calling attention to unsafe conditions. Although professionals have an obligation to expose themselves to risk, they are not obligated to expose themselves to inordinate risk. Prioritizing HCWs in ventilator triage may have been justified during the initial surge.

The use of surgical masks by all employees and patients has substantially reduced hospital transmission. A study at Duke Health, Raleigh, North Carolina, of HCWs who tested positive for SARS-CoV-2 between March 15, 2020, and June 6, 2020, found 22% of cases were healthcare acquired, 38% were community acquired, and 40% were of unknown acquisition route. Of the healthcare-acquired cases, 30% were thought to be secondary to direct patient care and 70% to exposure to another worker. The cumulative incidence rate of healthcare-acquired infections among workers decreased significantly 1 week after universal masking was implemented on March 31, 2020. The cumulative incidence rates of community-acquired cases and those with unknown acquisition routes continued to mirror incidence rates in the community.⁶ There is substantially less justification for prioritizing HCWs during the current phase of the pandemic; reciprocity does not justify granting HCWs infected via community spread greater priority than non-HCWs similarly infected.

There are other means of reciprocating that do not involve prioritization. COVID-19 has exacted an immense toll on the mental well-being of frontline HCWs. They should be provided robust, comprehensive, and accessible mental health services. Additionally, reciprocity can be expressed by providing alternative housing options for HCWs who are concerned about infecting their family members, especially family members at higher risk of morbidity or mortality from COVID-19. Many HCWs have also died from COVID-19^3; providing life insurance would recognize the sacrifice of HCWs and support their survivors. None of these interventions would require prioritizing HCWs over others.

As Daffner⁴ acknowledges, the category of “healthcare provider” is both over- and underinclusive. Healthcare providers are exposed to variable risks. Some physicians, for example, are no longer involved in direct patient care. It is unclear how triage teams will identify frontline HCWs or validate claims to being a frontline HCW, especially for individuals not employed by the hospital at which they are seeking care. Hence, triage protocols prioritizing healthcare providers are likely to be substantially overinclusive, which raises significant issues of fairness.

Moreover, the category “healthcare provider” is also underinclusive. Many essential, nonclinical hospital employees expose themselves to risk, including custodial and food service staff. As Daffner⁴ recognizes, there are also many other occupations outside of healthcare in which individuals voluntarily expose themselves to risks for the benefit of others, including police officers, firefighters, and clerks in grocery stores. We would add that workers in the food-supply system, transportation, and education face similar risks.⁷ Identifying the types of jobs that should confer priority and validating an individual’s employment also makes implementation difficult and risks injustice.

The COVID-19 pandemic and the murder of Black people by police have brought substantial attention to racism and racial inequities in the United States. We must, however, move from merely acknowledging existing inequities to dismantling structures that perpetuate them. The prioritization of HCWs may further privilege those who already have substantial advantages. This is especially true for physicians. For example, although state and federal laws pose limitations, physicians have historically extended one another professional courtesy by providing free or discounted services. Furthermore, HCWs and their family members are more likely to receive VIP treatment. For instance, when taken to the emergency department, children of physicians are less likely to have medical students and residents involved in their care and more likely to see attending physicians and consultants.⁸

In contrast, other categories of essential workers do not have such advantages. These workers are more likely to be members of marginalized racial and ethnic minority groups, have substantially lower wages, have less access to PPE, and work in more crowded conditions, and are less likely to have paid sick leave compared with HCWs.⁷ These workers are also more likely to lack access to quality healthcare. In fact, many safety net hospitals that provide care to marginalized communities have faced significant financial hardships as a result of the pandemic, and without additional support, some may close. Prioritizing HCWs will likely widen the gaps in health, economic, and social status among these groups.

With respect to allocation criteria, Black, Latinx, and Native American communities have more severe morbidity and mortality from COVID-19 as a result of racism and its interaction with other social determinants of health. Members of marginalized communities of color have a higher likelihood of becoming infected with COVID-19, a higher prevalence of comorbidities, and less access to treatment.⁷ Before her untimely death, Dr Susan Moore, a Black family physician, painfully described the racism to which she was subjected while being treated for COVID-19.⁹ The economic devastation caused by the pandemic, including unemployment, evictions, and food insecurity, compounds the impact of social determinants of health and disproportionately affects minority communities. Purely race- and ethnicity-based approaches to allocation to redress these inequities have potential limitations and obstacles, such as omission of other social determinants of health and legal challenges.⁷ While currently proposed for allocation of medications or vaccines, alternatives include using the Centers for Disease Control and Prevention’s Social Vulnerability Index⁸ or the Area Deprivation Index¹⁰ as a priority criterion. Most importantly, healthcare systems should more broadly demonstrate themselves trustworthy and assure that marginalized communities of color have access to quality healthcare services.

The United States has failed to adequately control the COVID-19 pandemic, and increasing numbers of admissions and staffing shortages have renewed concerns that hospitals will need to implement crisis standards of care. Daffner⁴ argues that healthcare providers should be prioritized in the allocation of critical care based on reciprocity. In the current phase of the pandemic, HCWs are more likely to be infected by one another or in the community than by patients. There are also other ways that hospitals can discharge this duty that do not require prioritizing HCWs over patients. The category of HCW is both over- and underinclusive, and Daffner⁴ has not shown that prioritization can be implemented fairly. Finally, inordinate attention has been paid to this topic. Much more attention should be focused on how to redress the ways in which the pandemic has exacerbated existing racial and ethnic inequities.

In their thoughtful response to the thesis that healthcare workers (HCWs) should be prioritized for scarce resources during a pandemic,¹ Antommaria and Unaka offer compelling reasons for opposing this position.² Common ground can be found in our shared recognition that the community has a reciprocal obligation to HCWs because of their willingness to accept the increased risk of being exposed to serious illness in caring for patients. We disagree on the most appropriate way to honor this obligation and whether HCWs currently have a greater risk of infection than others.

Antommaria and Unaka² indicate that “prioritizing HCWs …may have been justified during the initial surge” of coronavirus disease 2019 (COVID-19), when risk was excessive. They suggest that, with universal masking and other measures, infection rates among HCWs now mirror those in the community. However, this assessment is questionable. Personal protective equipment is still inadequate in numerous healthcare settings,^3,4 and many reports, including one by the National Academies, indicate that the threat to HCWs remains higher.⁵ In the absence of certainty, I favor erring on the side of continuing to recognize the special obligation to HCWs. Fortunately, COVID-19 vaccines should further reduce the danger of infection, and my article provides justification for prioritizing HCWs to receive them.

Antommaria and Unaka² seem to support special obligations to HCWs based on reciprocity, but suggest alternatives to critical care prioritization, such as mental health services and life insurance. In my view, mental health care should be universal and not a means of recognizing the sacrifice of HCWs. Providing life insurance for HCWs reflects a tacit acknowledgment of the increased threat they face. However, given governmental delays approving basic COVID-19 relief, it is unlikely that resources will be appropriated for life insurance, which has not occurred since Antommaria et al made this suggestion in 2011.⁶

Although there may be challenges to identifying and verifying frontline HCWs at risk for exposure to COVID-19, there are always gaps between the principles underlying policies and the way they are implemented. For example, according to guidelines from the Centers for Disease Control and Prevention,⁷ the first wave of individuals to receive COVID-19 vaccinations should include “frontline essential workers.” Defining and identifying this group of individuals provoke similar concerns to those raised by Antommaria and Unaka² about my proposal.

I concur that the narrow category of HCWs fails to include nonclinical and other frontline workers who are at a higher risk of being exposed to COVID-19. My article addresses this issue by suggesting the community has a similar set of obligations to these workers.¹ Nonclinical hospital workers are disproportionately non-White and have substantially lower median incomes than the average US wage earner.⁴ Moreover, among HCWs, people of color account for a disproportionate number of COVID-19 cases and deaths.⁴ Inclusion of at-risk nonclinical and other frontline workers in treatment prioritization is consistent with concerns about fairness that animate Antommaria and Unaka’s article.²

The importance of directing attention to the pandemic’s exacerbation of racial and ethnic inequalities, as highlighted by Antommaria and Unaka,² does not preclude also carefully examining whether special obligations are owed to HCWs and frontline workers. Thoughtful discussions about weighty ethical questions do not represent a zero-sum game, and, as in the current case, the issues raised during such deliberations often have much broader implications. Of note, social justice can be framed in terms of reciprocity, and efforts to confront societal inequities can reflect the special obligations owed Black Americans to address our long history of systemic racism.

In summary, fairness includes accounting for reciprocity and the duties resulting from it. Special obligations are owed HCWs and frontline workers until they are no longer at higher risk for infection. Hypothetical offers of life insurance or mental health benefits are inadequate ways to demonstrate reciprocity. The challenge of identifying HCWs and other frontline workers ought not preclude efforts to do so. HCWs and frontline workers should not automatically move to the head of the line to receive limited critical care resources. However, recognition of their willingness to risk serious infection should be included in the multidimensional calculus for triaging critical care.

In their thoughtful response to the thesis that healthcare workers (HCWs) should be prioritized for scarce resources during a pandemic,¹ Antommaria and Unaka offer compelling reasons for opposing this position.² Common ground can be found in our shared recognition that the community has a reciprocal obligation to HCWs because of their willingness to accept the increased risk of being exposed to serious illness in caring for patients. We disagree on the most appropriate way to honor this obligation and whether HCWs currently have a greater risk of infection than others.

Antommaria and Unaka² indicate that “prioritizing HCWs …may have been justified during the initial surge” of coronavirus disease 2019 (COVID-19), when risk was excessive. They suggest that, with universal masking and other measures, infection rates among HCWs now mirror those in the community. However, this assessment is questionable. Personal protective equipment is still inadequate in numerous healthcare settings,^3,4 and many reports, including one by the National Academies, indicate that the threat to HCWs remains higher.⁵ In the absence of certainty, I favor erring on the side of continuing to recognize the special obligation to HCWs. Fortunately, COVID-19 vaccines should further reduce the danger of infection, and my article provides justification for prioritizing HCWs to receive them.

Antommaria and Unaka² seem to support special obligations to HCWs based on reciprocity, but suggest alternatives to critical care prioritization, such as mental health services and life insurance. In my view, mental health care should be universal and not a means of recognizing the sacrifice of HCWs. Providing life insurance for HCWs reflects a tacit acknowledgment of the increased threat they face. However, given governmental delays approving basic COVID-19 relief, it is unlikely that resources will be appropriated for life insurance, which has not occurred since Antommaria et al made this suggestion in 2011.⁶

Although there may be challenges to identifying and verifying frontline HCWs at risk for exposure to COVID-19, there are always gaps between the principles underlying policies and the way they are implemented. For example, according to guidelines from the Centers for Disease Control and Prevention,⁷ the first wave of individuals to receive COVID-19 vaccinations should include “frontline essential workers.” Defining and identifying this group of individuals provoke similar concerns to those raised by Antommaria and Unaka² about my proposal.

I concur that the narrow category of HCWs fails to include nonclinical and other frontline workers who are at a higher risk of being exposed to COVID-19. My article addresses this issue by suggesting the community has a similar set of obligations to these workers.¹ Nonclinical hospital workers are disproportionately non-White and have substantially lower median incomes than the average US wage earner.⁴ Moreover, among HCWs, people of color account for a disproportionate number of COVID-19 cases and deaths.⁴ Inclusion of at-risk nonclinical and other frontline workers in treatment prioritization is consistent with concerns about fairness that animate Antommaria and Unaka’s article.²

The importance of directing attention to the pandemic’s exacerbation of racial and ethnic inequalities, as highlighted by Antommaria and Unaka,² does not preclude also carefully examining whether special obligations are owed to HCWs and frontline workers. Thoughtful discussions about weighty ethical questions do not represent a zero-sum game, and, as in the current case, the issues raised during such deliberations often have much broader implications. Of note, social justice can be framed in terms of reciprocity, and efforts to confront societal inequities can reflect the special obligations owed Black Americans to address our long history of systemic racism.

In summary, fairness includes accounting for reciprocity and the duties resulting from it. Special obligations are owed HCWs and frontline workers until they are no longer at higher risk for infection. Hypothetical offers of life insurance or mental health benefits are inadequate ways to demonstrate reciprocity. The challenge of identifying HCWs and other frontline workers ought not preclude efforts to do so. HCWs and frontline workers should not automatically move to the head of the line to receive limited critical care resources. However, recognition of their willingness to risk serious infection should be included in the multidimensional calculus for triaging critical care.

In their thoughtful response to the thesis that healthcare workers (HCWs) should be prioritized for scarce resources during a pandemic,¹ Antommaria and Unaka offer compelling reasons for opposing this position.² Common ground can be found in our shared recognition that the community has a reciprocal obligation to HCWs because of their willingness to accept the increased risk of being exposed to serious illness in caring for patients. We disagree on the most appropriate way to honor this obligation and whether HCWs currently have a greater risk of infection than others.

Antommaria and Unaka² indicate that “prioritizing HCWs …may have been justified during the initial surge” of coronavirus disease 2019 (COVID-19), when risk was excessive. They suggest that, with universal masking and other measures, infection rates among HCWs now mirror those in the community. However, this assessment is questionable. Personal protective equipment is still inadequate in numerous healthcare settings,^3,4 and many reports, including one by the National Academies, indicate that the threat to HCWs remains higher.⁵ In the absence of certainty, I favor erring on the side of continuing to recognize the special obligation to HCWs. Fortunately, COVID-19 vaccines should further reduce the danger of infection, and my article provides justification for prioritizing HCWs to receive them.

Antommaria and Unaka² seem to support special obligations to HCWs based on reciprocity, but suggest alternatives to critical care prioritization, such as mental health services and life insurance. In my view, mental health care should be universal and not a means of recognizing the sacrifice of HCWs. Providing life insurance for HCWs reflects a tacit acknowledgment of the increased threat they face. However, given governmental delays approving basic COVID-19 relief, it is unlikely that resources will be appropriated for life insurance, which has not occurred since Antommaria et al made this suggestion in 2011.⁶

Although there may be challenges to identifying and verifying frontline HCWs at risk for exposure to COVID-19, there are always gaps between the principles underlying policies and the way they are implemented. For example, according to guidelines from the Centers for Disease Control and Prevention,⁷ the first wave of individuals to receive COVID-19 vaccinations should include “frontline essential workers.” Defining and identifying this group of individuals provoke similar concerns to those raised by Antommaria and Unaka² about my proposal.

I concur that the narrow category of HCWs fails to include nonclinical and other frontline workers who are at a higher risk of being exposed to COVID-19. My article addresses this issue by suggesting the community has a similar set of obligations to these workers.¹ Nonclinical hospital workers are disproportionately non-White and have substantially lower median incomes than the average US wage earner.⁴ Moreover, among HCWs, people of color account for a disproportionate number of COVID-19 cases and deaths.⁴ Inclusion of at-risk nonclinical and other frontline workers in treatment prioritization is consistent with concerns about fairness that animate Antommaria and Unaka’s article.²

The importance of directing attention to the pandemic’s exacerbation of racial and ethnic inequalities, as highlighted by Antommaria and Unaka,² does not preclude also carefully examining whether special obligations are owed to HCWs and frontline workers. Thoughtful discussions about weighty ethical questions do not represent a zero-sum game, and, as in the current case, the issues raised during such deliberations often have much broader implications. Of note, social justice can be framed in terms of reciprocity, and efforts to confront societal inequities can reflect the special obligations owed Black Americans to address our long history of systemic racism.

In summary, fairness includes accounting for reciprocity and the duties resulting from it. Special obligations are owed HCWs and frontline workers until they are no longer at higher risk for infection. Hypothetical offers of life insurance or mental health benefits are inadequate ways to demonstrate reciprocity. The challenge of identifying HCWs and other frontline workers ought not preclude efforts to do so. HCWs and frontline workers should not automatically move to the head of the line to receive limited critical care resources. However, recognition of their willingness to risk serious infection should be included in the multidimensional calculus for triaging critical care.

In their report celebrating the increase in the number of hospitalists from a few hundred in the 1990s to more than 50,000 in 2016, Drs Robert Wachter and Lee Goldman also noted the stunted growth of productive hospital medicine research programs, which presents a challenge to academic credibility in hospital medicine.¹ Given the substantial increase in the number of hospitalists over the past two decades, we surveyed adult academic hospital medicine groups to quantify the number of hospitalist clinician investigators and identify gaps in resources for researchers. The number of clinician investigators supported at academic medical centers (AMCs) remains disturbingly low despite the rapid growth of our specialty. Some programs also reported a lack of access to fundamental research services. We report selected results from our survey and provide recommendations to support and facilitate the development of clinician investigators in hospital medicine.

We performed a survey of hospital medicine programs at AMCs in the United States through the Hospital Medicine Reengineering Network (HOMERuN), a hospital medicine research collaborative that facilitates and conducts multisite research studies.² The purpose of this survey was to obtain a profile of adult academic hospital medicine groups. Surveys were distributed via email to directors and/or senior leaders of each hospital medicine group between January and August 2019. In the survey, a clinician investigator was defined as “faculty whose primary nonclinical focus is scientific papers and grant writing.”

We received responses from 43 of the 86 invitees (50%), each of whom represented a unique hospital medicine group; 41 of the representatives responded to the questions concerning available research services. Collectively, these 43 programs represented 2,503 hospitalists. There were 79 clinician investigators reported among all surveyed hospital medicine groups (3.1% of all hospitalists). The median number of clinician investigators per hospital medicine group was 0 (range 0-12) (Appendix Figure 1), and 22 of 43 (51.2%) hospital medicine groups reported having no clinician investigators. Two of the hospital medicine groups, however, reported having 12 clinician investigators at their respective institutions, comprising nearly one third of the total number of clinician investigators reported in the survey.

Many of the programs reported lack of access to resources such as research assistants (56.1%) and dedicated research fellowships (53.7%) (Appendix Figure 2). A number of groups reported a need for more support for various junior faculty development activities, including research mentoring (53.5%), networking with other researchers (60.5%), and access to clinical data from multiple sites (62.8%).

One of the limitations of this survey was the manner in which the participating hospital medicine groups were chosen. Selection was based on groups affiliated with HOMERuN; among those chosen were highly visible US AMCs, including 70% of the top 20 AMCs based on National Institutes of Health (NIH) funding.³ Therefore, our results likely overestimate the research presence of hospital medicine across all AMCs in the United States.

Despite the substantial growth of hospital medicine over the past 2 decades, there has been no proportional increase in the number of hospitalist clinician investigators, with earlier surveys also demonstrating low numbers.^4,5 Along with the survey by Chopra and colleagues published in 2019,⁶ our survey provides an additional contemporary appraisal of research activities for adult academic hospital medicine groups. In the survey by Chopra et al, only 54% (15 of 28) of responding programs reported having any faculty with research as their major activity (ie, >50% effort), and 3% of total faculty reported having funding for >50% effort toward research.⁶ Our study expands upon these findings by providing more detailed data on the number of clinician investigators per hospital medicine group. Results of our survey showed a concentration of hospitalists within a small number of programs, which may have contributed to the observed lack of growth. We also expand on prior work by identifying a lack of resources and services to support hospitalist researchers.

The findings of our survey have important implications for the field of hospital medicine. Without a critical mass of hospitalist clinician investigators, the quality of research that addresses important questions in our field will suffer. It will also limit academic credibility of the field, as well as individual academic achievement; previous studies have consistently demonstrated that few hospitalists at AMCs achieve the rank of associate or full professor.^5-9

The results of our study additionally offer possible explanations for the dearth of clinician investigators in hospital medicine. The limited access to research resources and fellowship training identified in our survey are critical domains that must be addressed in order to develop successful academic hospital medicine programs.^4,6,8,10

Regarding dedicated hospital medicine research fellowships, there are only a handful across the country. The small number of existing research fellowships only have one or two fellows per year, and these positions often go unfilled because of a lack of applicants and lower salaries compared to full-time clinical positions.¹¹ The lack of applicants for adult hospital medicine fellowship positions is also integrally linked to board certification requirements. Unlike pediatric hospital medicine where additional fellowship training is required to become board-certified, no such fellowship is required in adult hospital medicine. In pediatrics, this requirement has led to a rapid increase in the number of fellowships with scholarly work requirements (more than 60 fellowships, plus additional programs in development) and greater standardization among training experiences.^12,13

The lack of fellowship applicants may also stem from the fact that many trainees are not aware of a potential career as a hospitalist clinician investigator due to limited exposure to this career at most AMCs. Our results revealed that nearly half of sites in our survey had zero clinician investigators, depriving trainees at these programs of role models and thus perpetuating a negative feedback loop. Lastly, although unfilled fellowship positions may indicate that demand is a larger problem than supply, it is also true that fellowship programs generate their own demand through recruitment efforts and the gradual establishment of a positive reputation.

Another potential explanation could relate to the development of hospital medicine in response to rising clinical demands at hospitals: compared with other medical specialties, AMCs may regard hospitalists as being clinicians first and academicians second.^1,7,10 Also, hospitalists may be perceived as being beholden to hospitals and less engaged with their surrounding communities than other general medicine fields. With a small footprint in health equity research, academic hospital medicine may be less of a draw to generalists interested in pursuing this area of research. Further, there are very few underrepresented in medicine (URiM) hospital medicine research faculty.⁵

Another challenge to the career development of hospitalist researchers is the lack of available funding for the type of research typically conducted by hospitalists (eg, rigorous quality improvement implementation and evaluation, optimizing best evidence-based care delivery models, evaluation of patient safety in the hospital setting). As hospitalists tend to be system-level thinkers, this lack of funding may steer potential researchers away from externally funded research careers and into hospital operations and quality improvement positions. Also, unlike other medical specialties, there is no dedicated NIH funding source for hospital medicine research (eg, cardiology and the National Heart, Lung, and Blood Institute), placing hospitalists at a disadvantage in seeking funding compared to subspecialists.

We recommend several approaches—ones that should be pursued simultaneously—to increase the number of clinician investigators in hospital medicine. First, hospital medicine groups and their respective divisions, departments, and hospitals should allocate funding to support research resources; this includes investing in research assistants, data analysts, statisticians, and administrative support. Through the funding of such research infrastructure programs, AMCs could incentivize hospitalists to research best approaches to improve the value of healthcare delivery, ultimately leading to cost savings.

With 60% of respondents identifying the need for improved access to data across multiple sites, our survey also emphasizes the requirement for further collaboration among hospital medicine groups. Such collaboration could lead to high-powered observational studies and the evaluation of interventions across multiple sites, thus improving the generalizability of study findings.

The Society of Hospital Medicine (SHM) and its research committee can continue to expand the research footprint of hospital medicine. To date, the committee has achieved this by highlighting hospitalist research activity at the SHM Annual Conference Scientific Abstract and Poster Competition and developing a visiting professorship exchange program. In addition to these efforts, SHM could foster collaboration and networking between institutions, as well as take advantage of the current political push for expanded Medicare access by lobbying for robust funding for the Agency for Healthcare Research and Quality, which could provide more opportunities for hospitalists to study the effects of healthcare policy reform on the delivery of inpatient care.

Another strategy to increase the number of hospitalist clinician investigators is to expand hospital medicine research fellowships and recruit trainees for these programs. Fellowships could be internally funded wherein a fellow’s clinical productivity is used to offset the costs associated with obtaining advanced degrees. As an incentive to encourage applicants to temporarily forego a full-time clinical salary during fellowship, hospital medicine groups could offer expanded moonlighting opportunities and contribute to repayment of medical school loans. Hospital medicine groups should also advocate for NIH-funded T32 or K12 training grants for hospital medicine. (There are, however, challenges with this approach because the number of T32 spots per NIH institute is usually fixed). The success of academic emergency medicine offers a precedent for such efforts: After the development of a K12 research training program in emergency medicine, the number of NIH-sponsored principal investigators in this specialty increased by 40% in 6 years.¹⁴ Additionally, now that fellowships are required for the pediatric hospital medicine clinician investigators, it would be revealing to track the growth of this workforce.^12,13

Structured and formalized mentorship is an essential part of the development of clinician investigators in hospital medicine.^4,7,8,10 One successful strategy for mentorship has been the partnering of hospital medicine groups with faculty of general internal medicine and other subspecialty divisions with robust research programs.^7,8,15 In addition to developing sustainable mentorship programs, hospital medicine researchers must increase their visibility to trainees. Therefore, it is essential that the majority of academic hospital medicine groups not only hire clinician investigators but also invest in their development, rather than rely on the few programs that have several such faculty members. With this strategy, we could dramatically increase the number of hospitalist clinician investigators from a diverse background of training institutions.

SHM could also play a greater role in organizing events for networking and mentoring for trainees and medical students interested in pursuing a career in hospital medicine research. It is also critically important that hospital medicine groups actively recruit, retain, and develop URiM hospital medicine research faculty in order to attract talented researchers and actively participate in the necessary effort to mitigate the inequities prevalent throughout our healthcare system.

Despite the growth of hospital medicine over the past decade, there remains a dearth of hospitalist clinician investigators at major AMCs in the United States. This may be due in part to lack of research resources and mentorship within hospital medicine groups. We believe that investment in these resources, expanded funding opportunities, mentorship development, research fellowship programs, and greater exposure of trainees to hospitalist researchers are solutions that should be strongly considered to develop hospitalist clinician investigators.

The authors thank HOMERuN executive committee members, including Grant Fletcher, MD, James Harrison, PhD, BSC, MPH, Peter K. Lindenauer, MD, Melissa Mattison, MD, David Meltzer, MD, PhD, Joshua Metlay, MD, PhD, Jennifer Myers, MD, Sumant Ranji, MD, Gregory Ruhnke, MD, MPH, Edmondo Robinson, MD, MBA, and Neil Sehgal, MPH PhD, for their assistance in developing the survey. They also thank Tiffany Lee, MA, for her project management assistance for HOMERuN.

In their report celebrating the increase in the number of hospitalists from a few hundred in the 1990s to more than 50,000 in 2016, Drs Robert Wachter and Lee Goldman also noted the stunted growth of productive hospital medicine research programs, which presents a challenge to academic credibility in hospital medicine.¹ Given the substantial increase in the number of hospitalists over the past two decades, we surveyed adult academic hospital medicine groups to quantify the number of hospitalist clinician investigators and identify gaps in resources for researchers. The number of clinician investigators supported at academic medical centers (AMCs) remains disturbingly low despite the rapid growth of our specialty. Some programs also reported a lack of access to fundamental research services. We report selected results from our survey and provide recommendations to support and facilitate the development of clinician investigators in hospital medicine.

We performed a survey of hospital medicine programs at AMCs in the United States through the Hospital Medicine Reengineering Network (HOMERuN), a hospital medicine research collaborative that facilitates and conducts multisite research studies.² The purpose of this survey was to obtain a profile of adult academic hospital medicine groups. Surveys were distributed via email to directors and/or senior leaders of each hospital medicine group between January and August 2019. In the survey, a clinician investigator was defined as “faculty whose primary nonclinical focus is scientific papers and grant writing.”

We received responses from 43 of the 86 invitees (50%), each of whom represented a unique hospital medicine group; 41 of the representatives responded to the questions concerning available research services. Collectively, these 43 programs represented 2,503 hospitalists. There were 79 clinician investigators reported among all surveyed hospital medicine groups (3.1% of all hospitalists). The median number of clinician investigators per hospital medicine group was 0 (range 0-12) (Appendix Figure 1), and 22 of 43 (51.2%) hospital medicine groups reported having no clinician investigators. Two of the hospital medicine groups, however, reported having 12 clinician investigators at their respective institutions, comprising nearly one third of the total number of clinician investigators reported in the survey.

Many of the programs reported lack of access to resources such as research assistants (56.1%) and dedicated research fellowships (53.7%) (Appendix Figure 2). A number of groups reported a need for more support for various junior faculty development activities, including research mentoring (53.5%), networking with other researchers (60.5%), and access to clinical data from multiple sites (62.8%).

One of the limitations of this survey was the manner in which the participating hospital medicine groups were chosen. Selection was based on groups affiliated with HOMERuN; among those chosen were highly visible US AMCs, including 70% of the top 20 AMCs based on National Institutes of Health (NIH) funding.³ Therefore, our results likely overestimate the research presence of hospital medicine across all AMCs in the United States.

Despite the substantial growth of hospital medicine over the past 2 decades, there has been no proportional increase in the number of hospitalist clinician investigators, with earlier surveys also demonstrating low numbers.^4,5 Along with the survey by Chopra and colleagues published in 2019,⁶ our survey provides an additional contemporary appraisal of research activities for adult academic hospital medicine groups. In the survey by Chopra et al, only 54% (15 of 28) of responding programs reported having any faculty with research as their major activity (ie, >50% effort), and 3% of total faculty reported having funding for >50% effort toward research.⁶ Our study expands upon these findings by providing more detailed data on the number of clinician investigators per hospital medicine group. Results of our survey showed a concentration of hospitalists within a small number of programs, which may have contributed to the observed lack of growth. We also expand on prior work by identifying a lack of resources and services to support hospitalist researchers.

The findings of our survey have important implications for the field of hospital medicine. Without a critical mass of hospitalist clinician investigators, the quality of research that addresses important questions in our field will suffer. It will also limit academic credibility of the field, as well as individual academic achievement; previous studies have consistently demonstrated that few hospitalists at AMCs achieve the rank of associate or full professor.^5-9

The results of our study additionally offer possible explanations for the dearth of clinician investigators in hospital medicine. The limited access to research resources and fellowship training identified in our survey are critical domains that must be addressed in order to develop successful academic hospital medicine programs.^4,6,8,10

Regarding dedicated hospital medicine research fellowships, there are only a handful across the country. The small number of existing research fellowships only have one or two fellows per year, and these positions often go unfilled because of a lack of applicants and lower salaries compared to full-time clinical positions.¹¹ The lack of applicants for adult hospital medicine fellowship positions is also integrally linked to board certification requirements. Unlike pediatric hospital medicine where additional fellowship training is required to become board-certified, no such fellowship is required in adult hospital medicine. In pediatrics, this requirement has led to a rapid increase in the number of fellowships with scholarly work requirements (more than 60 fellowships, plus additional programs in development) and greater standardization among training experiences.^12,13

The lack of fellowship applicants may also stem from the fact that many trainees are not aware of a potential career as a hospitalist clinician investigator due to limited exposure to this career at most AMCs. Our results revealed that nearly half of sites in our survey had zero clinician investigators, depriving trainees at these programs of role models and thus perpetuating a negative feedback loop. Lastly, although unfilled fellowship positions may indicate that demand is a larger problem than supply, it is also true that fellowship programs generate their own demand through recruitment efforts and the gradual establishment of a positive reputation.

Another potential explanation could relate to the development of hospital medicine in response to rising clinical demands at hospitals: compared with other medical specialties, AMCs may regard hospitalists as being clinicians first and academicians second.^1,7,10 Also, hospitalists may be perceived as being beholden to hospitals and less engaged with their surrounding communities than other general medicine fields. With a small footprint in health equity research, academic hospital medicine may be less of a draw to generalists interested in pursuing this area of research. Further, there are very few underrepresented in medicine (URiM) hospital medicine research faculty.⁵

Another challenge to the career development of hospitalist researchers is the lack of available funding for the type of research typically conducted by hospitalists (eg, rigorous quality improvement implementation and evaluation, optimizing best evidence-based care delivery models, evaluation of patient safety in the hospital setting). As hospitalists tend to be system-level thinkers, this lack of funding may steer potential researchers away from externally funded research careers and into hospital operations and quality improvement positions. Also, unlike other medical specialties, there is no dedicated NIH funding source for hospital medicine research (eg, cardiology and the National Heart, Lung, and Blood Institute), placing hospitalists at a disadvantage in seeking funding compared to subspecialists.

We recommend several approaches—ones that should be pursued simultaneously—to increase the number of clinician investigators in hospital medicine. First, hospital medicine groups and their respective divisions, departments, and hospitals should allocate funding to support research resources; this includes investing in research assistants, data analysts, statisticians, and administrative support. Through the funding of such research infrastructure programs, AMCs could incentivize hospitalists to research best approaches to improve the value of healthcare delivery, ultimately leading to cost savings.

With 60% of respondents identifying the need for improved access to data across multiple sites, our survey also emphasizes the requirement for further collaboration among hospital medicine groups. Such collaboration could lead to high-powered observational studies and the evaluation of interventions across multiple sites, thus improving the generalizability of study findings.

The Society of Hospital Medicine (SHM) and its research committee can continue to expand the research footprint of hospital medicine. To date, the committee has achieved this by highlighting hospitalist research activity at the SHM Annual Conference Scientific Abstract and Poster Competition and developing a visiting professorship exchange program. In addition to these efforts, SHM could foster collaboration and networking between institutions, as well as take advantage of the current political push for expanded Medicare access by lobbying for robust funding for the Agency for Healthcare Research and Quality, which could provide more opportunities for hospitalists to study the effects of healthcare policy reform on the delivery of inpatient care.

Another strategy to increase the number of hospitalist clinician investigators is to expand hospital medicine research fellowships and recruit trainees for these programs. Fellowships could be internally funded wherein a fellow’s clinical productivity is used to offset the costs associated with obtaining advanced degrees. As an incentive to encourage applicants to temporarily forego a full-time clinical salary during fellowship, hospital medicine groups could offer expanded moonlighting opportunities and contribute to repayment of medical school loans. Hospital medicine groups should also advocate for NIH-funded T32 or K12 training grants for hospital medicine. (There are, however, challenges with this approach because the number of T32 spots per NIH institute is usually fixed). The success of academic emergency medicine offers a precedent for such efforts: After the development of a K12 research training program in emergency medicine, the number of NIH-sponsored principal investigators in this specialty increased by 40% in 6 years.¹⁴ Additionally, now that fellowships are required for the pediatric hospital medicine clinician investigators, it would be revealing to track the growth of this workforce.^12,13

Structured and formalized mentorship is an essential part of the development of clinician investigators in hospital medicine.^4,7,8,10 One successful strategy for mentorship has been the partnering of hospital medicine groups with faculty of general internal medicine and other subspecialty divisions with robust research programs.^7,8,15 In addition to developing sustainable mentorship programs, hospital medicine researchers must increase their visibility to trainees. Therefore, it is essential that the majority of academic hospital medicine groups not only hire clinician investigators but also invest in their development, rather than rely on the few programs that have several such faculty members. With this strategy, we could dramatically increase the number of hospitalist clinician investigators from a diverse background of training institutions.

SHM could also play a greater role in organizing events for networking and mentoring for trainees and medical students interested in pursuing a career in hospital medicine research. It is also critically important that hospital medicine groups actively recruit, retain, and develop URiM hospital medicine research faculty in order to attract talented researchers and actively participate in the necessary effort to mitigate the inequities prevalent throughout our healthcare system.

Despite the growth of hospital medicine over the past decade, there remains a dearth of hospitalist clinician investigators at major AMCs in the United States. This may be due in part to lack of research resources and mentorship within hospital medicine groups. We believe that investment in these resources, expanded funding opportunities, mentorship development, research fellowship programs, and greater exposure of trainees to hospitalist researchers are solutions that should be strongly considered to develop hospitalist clinician investigators.

The authors thank HOMERuN executive committee members, including Grant Fletcher, MD, James Harrison, PhD, BSC, MPH, Peter K. Lindenauer, MD, Melissa Mattison, MD, David Meltzer, MD, PhD, Joshua Metlay, MD, PhD, Jennifer Myers, MD, Sumant Ranji, MD, Gregory Ruhnke, MD, MPH, Edmondo Robinson, MD, MBA, and Neil Sehgal, MPH PhD, for their assistance in developing the survey. They also thank Tiffany Lee, MA, for her project management assistance for HOMERuN.

In their report celebrating the increase in the number of hospitalists from a few hundred in the 1990s to more than 50,000 in 2016, Drs Robert Wachter and Lee Goldman also noted the stunted growth of productive hospital medicine research programs, which presents a challenge to academic credibility in hospital medicine.¹ Given the substantial increase in the number of hospitalists over the past two decades, we surveyed adult academic hospital medicine groups to quantify the number of hospitalist clinician investigators and identify gaps in resources for researchers. The number of clinician investigators supported at academic medical centers (AMCs) remains disturbingly low despite the rapid growth of our specialty. Some programs also reported a lack of access to fundamental research services. We report selected results from our survey and provide recommendations to support and facilitate the development of clinician investigators in hospital medicine.

We performed a survey of hospital medicine programs at AMCs in the United States through the Hospital Medicine Reengineering Network (HOMERuN), a hospital medicine research collaborative that facilitates and conducts multisite research studies.² The purpose of this survey was to obtain a profile of adult academic hospital medicine groups. Surveys were distributed via email to directors and/or senior leaders of each hospital medicine group between January and August 2019. In the survey, a clinician investigator was defined as “faculty whose primary nonclinical focus is scientific papers and grant writing.”

We received responses from 43 of the 86 invitees (50%), each of whom represented a unique hospital medicine group; 41 of the representatives responded to the questions concerning available research services. Collectively, these 43 programs represented 2,503 hospitalists. There were 79 clinician investigators reported among all surveyed hospital medicine groups (3.1% of all hospitalists). The median number of clinician investigators per hospital medicine group was 0 (range 0-12) (Appendix Figure 1), and 22 of 43 (51.2%) hospital medicine groups reported having no clinician investigators. Two of the hospital medicine groups, however, reported having 12 clinician investigators at their respective institutions, comprising nearly one third of the total number of clinician investigators reported in the survey.

Many of the programs reported lack of access to resources such as research assistants (56.1%) and dedicated research fellowships (53.7%) (Appendix Figure 2). A number of groups reported a need for more support for various junior faculty development activities, including research mentoring (53.5%), networking with other researchers (60.5%), and access to clinical data from multiple sites (62.8%).

One of the limitations of this survey was the manner in which the participating hospital medicine groups were chosen. Selection was based on groups affiliated with HOMERuN; among those chosen were highly visible US AMCs, including 70% of the top 20 AMCs based on National Institutes of Health (NIH) funding.³ Therefore, our results likely overestimate the research presence of hospital medicine across all AMCs in the United States.

Despite the substantial growth of hospital medicine over the past 2 decades, there has been no proportional increase in the number of hospitalist clinician investigators, with earlier surveys also demonstrating low numbers.^4,5 Along with the survey by Chopra and colleagues published in 2019,⁶ our survey provides an additional contemporary appraisal of research activities for adult academic hospital medicine groups. In the survey by Chopra et al, only 54% (15 of 28) of responding programs reported having any faculty with research as their major activity (ie, >50% effort), and 3% of total faculty reported having funding for >50% effort toward research.⁶ Our study expands upon these findings by providing more detailed data on the number of clinician investigators per hospital medicine group. Results of our survey showed a concentration of hospitalists within a small number of programs, which may have contributed to the observed lack of growth. We also expand on prior work by identifying a lack of resources and services to support hospitalist researchers.

The findings of our survey have important implications for the field of hospital medicine. Without a critical mass of hospitalist clinician investigators, the quality of research that addresses important questions in our field will suffer. It will also limit academic credibility of the field, as well as individual academic achievement; previous studies have consistently demonstrated that few hospitalists at AMCs achieve the rank of associate or full professor.^5-9

The results of our study additionally offer possible explanations for the dearth of clinician investigators in hospital medicine. The limited access to research resources and fellowship training identified in our survey are critical domains that must be addressed in order to develop successful academic hospital medicine programs.^4,6,8,10

Regarding dedicated hospital medicine research fellowships, there are only a handful across the country. The small number of existing research fellowships only have one or two fellows per year, and these positions often go unfilled because of a lack of applicants and lower salaries compared to full-time clinical positions.¹¹ The lack of applicants for adult hospital medicine fellowship positions is also integrally linked to board certification requirements. Unlike pediatric hospital medicine where additional fellowship training is required to become board-certified, no such fellowship is required in adult hospital medicine. In pediatrics, this requirement has led to a rapid increase in the number of fellowships with scholarly work requirements (more than 60 fellowships, plus additional programs in development) and greater standardization among training experiences.^12,13

The lack of fellowship applicants may also stem from the fact that many trainees are not aware of a potential career as a hospitalist clinician investigator due to limited exposure to this career at most AMCs. Our results revealed that nearly half of sites in our survey had zero clinician investigators, depriving trainees at these programs of role models and thus perpetuating a negative feedback loop. Lastly, although unfilled fellowship positions may indicate that demand is a larger problem than supply, it is also true that fellowship programs generate their own demand through recruitment efforts and the gradual establishment of a positive reputation.

Another potential explanation could relate to the development of hospital medicine in response to rising clinical demands at hospitals: compared with other medical specialties, AMCs may regard hospitalists as being clinicians first and academicians second.^1,7,10 Also, hospitalists may be perceived as being beholden to hospitals and less engaged with their surrounding communities than other general medicine fields. With a small footprint in health equity research, academic hospital medicine may be less of a draw to generalists interested in pursuing this area of research. Further, there are very few underrepresented in medicine (URiM) hospital medicine research faculty.⁵

Another challenge to the career development of hospitalist researchers is the lack of available funding for the type of research typically conducted by hospitalists (eg, rigorous quality improvement implementation and evaluation, optimizing best evidence-based care delivery models, evaluation of patient safety in the hospital setting). As hospitalists tend to be system-level thinkers, this lack of funding may steer potential researchers away from externally funded research careers and into hospital operations and quality improvement positions. Also, unlike other medical specialties, there is no dedicated NIH funding source for hospital medicine research (eg, cardiology and the National Heart, Lung, and Blood Institute), placing hospitalists at a disadvantage in seeking funding compared to subspecialists.

We recommend several approaches—ones that should be pursued simultaneously—to increase the number of clinician investigators in hospital medicine. First, hospital medicine groups and their respective divisions, departments, and hospitals should allocate funding to support research resources; this includes investing in research assistants, data analysts, statisticians, and administrative support. Through the funding of such research infrastructure programs, AMCs could incentivize hospitalists to research best approaches to improve the value of healthcare delivery, ultimately leading to cost savings.

With 60% of respondents identifying the need for improved access to data across multiple sites, our survey also emphasizes the requirement for further collaboration among hospital medicine groups. Such collaboration could lead to high-powered observational studies and the evaluation of interventions across multiple sites, thus improving the generalizability of study findings.

The Society of Hospital Medicine (SHM) and its research committee can continue to expand the research footprint of hospital medicine. To date, the committee has achieved this by highlighting hospitalist research activity at the SHM Annual Conference Scientific Abstract and Poster Competition and developing a visiting professorship exchange program. In addition to these efforts, SHM could foster collaboration and networking between institutions, as well as take advantage of the current political push for expanded Medicare access by lobbying for robust funding for the Agency for Healthcare Research and Quality, which could provide more opportunities for hospitalists to study the effects of healthcare policy reform on the delivery of inpatient care.

Another strategy to increase the number of hospitalist clinician investigators is to expand hospital medicine research fellowships and recruit trainees for these programs. Fellowships could be internally funded wherein a fellow’s clinical productivity is used to offset the costs associated with obtaining advanced degrees. As an incentive to encourage applicants to temporarily forego a full-time clinical salary during fellowship, hospital medicine groups could offer expanded moonlighting opportunities and contribute to repayment of medical school loans. Hospital medicine groups should also advocate for NIH-funded T32 or K12 training grants for hospital medicine. (There are, however, challenges with this approach because the number of T32 spots per NIH institute is usually fixed). The success of academic emergency medicine offers a precedent for such efforts: After the development of a K12 research training program in emergency medicine, the number of NIH-sponsored principal investigators in this specialty increased by 40% in 6 years.¹⁴ Additionally, now that fellowships are required for the pediatric hospital medicine clinician investigators, it would be revealing to track the growth of this workforce.^12,13

Structured and formalized mentorship is an essential part of the development of clinician investigators in hospital medicine.^4,7,8,10 One successful strategy for mentorship has been the partnering of hospital medicine groups with faculty of general internal medicine and other subspecialty divisions with robust research programs.^7,8,15 In addition to developing sustainable mentorship programs, hospital medicine researchers must increase their visibility to trainees. Therefore, it is essential that the majority of academic hospital medicine groups not only hire clinician investigators but also invest in their development, rather than rely on the few programs that have several such faculty members. With this strategy, we could dramatically increase the number of hospitalist clinician investigators from a diverse background of training institutions.

SHM could also play a greater role in organizing events for networking and mentoring for trainees and medical students interested in pursuing a career in hospital medicine research. It is also critically important that hospital medicine groups actively recruit, retain, and develop URiM hospital medicine research faculty in order to attract talented researchers and actively participate in the necessary effort to mitigate the inequities prevalent throughout our healthcare system.

Despite the growth of hospital medicine over the past decade, there remains a dearth of hospitalist clinician investigators at major AMCs in the United States. This may be due in part to lack of research resources and mentorship within hospital medicine groups. We believe that investment in these resources, expanded funding opportunities, mentorship development, research fellowship programs, and greater exposure of trainees to hospitalist researchers are solutions that should be strongly considered to develop hospitalist clinician investigators.

The authors thank HOMERuN executive committee members, including Grant Fletcher, MD, James Harrison, PhD, BSC, MPH, Peter K. Lindenauer, MD, Melissa Mattison, MD, David Meltzer, MD, PhD, Joshua Metlay, MD, PhD, Jennifer Myers, MD, Sumant Ranji, MD, Gregory Ruhnke, MD, MPH, Edmondo Robinson, MD, MBA, and Neil Sehgal, MPH PhD, for their assistance in developing the survey. They also thank Tiffany Lee, MA, for her project management assistance for HOMERuN.

Adults with communication-based disabilities struggle with healthcare inequities,^1-4 largely secondary to poor healthcare provider-patient communication. The prevalence of communication-based disabilities, which include speech, language, voice, and/or hearing disabilities, is relatively high yet difficult to ascertain. Ten percent of adults in the United States report having had a speech, language, or voice disability within the past year,⁵ and hearing loss also affects 17% of the US population.⁶ These individuals’ collective communication difficulties have been exacerbated by the coronavirus disease 2019 (COVID-19) pandemic, with healthcare systems mandating personal protective equipment (PPE), including face masks, to ensure the safety of workers and patients. This change has placed patients with communication-based disabilities at even greater risk for communication breakdowns.^7,8

Hospitals pose challenging communicative environments due to multiple factors (eg, noisy equipment alarms, harried healthcare teams spending less time with patients, PPE use obstructing faces and muffling sounds). Adverse communication among those with communication-based disabilities results in poorer healthcare outcomes, including higher rates of readmission and preventable adverse medical events, as well as lower healthcare satisfaction.^7,9,10 Ineffective communication leads to reduced adherence, longer hospitalizations, and worse health outcomes in general.^11-13 This is problematic because those with communication-based disabilities are more likely to require hospitalization due to higher rates of associated comorbidities, including frailty, cardiovascular disease, cognitive decline, and falls.^4,14-16 Yet hospitals rarely screen and implement best practices to ensure effective and accessible communication for those with communication-based disabilities. The COVID-19 pandemic has exacerbated existing barriers, despite feasible solutions. Importantly, the Americans with Disabilities Act (ADA) remains in effect despite the pandemic. Therefore, hospitals should review existing policies and approaches to ensure adherence to ADA mandates. We address commonly encountered COVID-19-related communication barriers and recommend potential solutions.¹⁷

Limited Time or Support

Patients with communication-based disabilities may need more time than others to communicate their needs, values, and preferences effectively, whether due to slower articulation (eg, movement disorders) or communicating via an intermediary (eg, family member who understands them well) or an interpreter. Due to capacity or patient acuity issues, or even concerns about minimizing time in the room of a patient infected with COVID-19, hospital staff may inadvertently spend less time than needed to develop the necessary therapeutic relationships. This concern is magnified when restrictive visitor policies limit the availability of caregivers, such as loved ones, who assist at the bedside with communication.¹⁸

Universal Masking and Face Shields

Standard face masks, now required for all in-person encounters regardless of the patient’s COVID-19 status, obstruct the view of the lips and many facial expressions. Facial cues are an important form of nonverbal communication and are critical to conveying meaning in sign language. Face masks, particularly N95 respirators, substantially degrade speech perception.¹⁹ Masking increases the difficulty of acoustically and visually understanding patients who have disorders that decrease speech intelligibility, such as dysphonia, dysarthria, or apraxic speech. Environmental noise reduces general speech perception and can be especially problematic for both those struggling with a hearing loss and for healthcare workers trying to understand masked patients with speech or language disorders.²⁰ In addition, transparent face shields along with other eye protection equipment are commonly combined with face masks during encounters with patients with and without COVID-19. These face shields, while generally transparent, further muffle spoken sounds.²¹ Fogging of face shields, often when used with face masks, further impedes appreciation of facial expressions.

Interpreters

For deaf and hard-of-hearing people who use American Sign Language (ASL) as their preferred healthcare communication method, interpreters play a critical role in ensuring accessible healthcare communication. Signed language interpretation can occur in person or remotely by video. For in-person interpretation, interpreters must likewise wear PPE. The use of PPE, including face masks, can obscure many of the facial cues important to ASL grammar. Similarly, patients’ face masks can make it more challenging for interpreters to interpret effectively. With remote video interpretation, technological difficulties (eg, dropped WiFi connections) and the loss of environmental cues (eg, interpreter at a remote location unable to see or hear patient surroundings) often mar opportunities for accessible and effective communication. For the DeafBlind community, the use of remote video interpretation is not feasible. DeafBlind people rely on tactile forms of ASL, requiring interpreters’ physical touch throughout the communication encounter. This potentially increases COVID-19 transmission risk.

While some of the solutions listed below also apply to communication in nonpandemic times, identifying high-risk patients and anticipatory planning for communication has become even more important during the COVID-19 outbreak.

Identification and Assessment of Communication Breakdown Risks

Hospital staff should systematically review admission and transfer protocols to ensure every patient is asked about their communication preferences, necessary accommodations, and specific needs. Any communication needs or accommodation requests (eg, interpreters, communication boards) should be documented and flagged in highly visible areas of the electronic health record. These patients should be assessed regularly to ensure their communication needs are being met and documented throughout their hospital stay.

Assistive Communication Steps

Some steps can be performed in advance. Careful consideration should be given to healthcare providers’ ability to spend additional time with patients with communication-based disabilities. Even if providers are limited physically in the room, they can still work to optimize mindful, high-quality communication by calling into the patient’s room by phone or video. The additional time is important especially when establishing rapport with patients and identifying their preferred communication approaches, as well as engaging their support networks. Patients with communication-based disabilities and their support team often have expertise on their ideal communication strategies. Healthcare providers and staff should inquire about communication preferences. Patients should also be oriented to hospital team structure and members, which could include simple solutions such as legible name tags. Hearing aids, batteries, and other assistive technology should have designated places to prevent loss and ensure ongoing working status. In addition, nurse stations should have a communication toolbox that includes replacement batteries for hearing aids along with other assistive technology devices, such as a personal sound amplification product.

Communication Strategies

Healthcare teams should be trained and reminded to use patient-centered communication strategies, including assessing their comprehension of shared health information through teach-back principles. Strategies vary by patient and may require teams’ flexibility in meeting the patient’s needs and preferences. Examples include ensuring one has the patient’s attention and uses good eye contact. Using a projected “radio voice,” which emphasizes clarity and articulation rather than volume, is helpful for those with hearing loss. For some, meaningful gestures (eg, pointing to one’s own head when asking about headaches) can aid communication. Another strategy when having difficulty understanding patients with decreased speech intelligibility is to repeat the audible speech so that the patient only needs to repeat the inaudible portions that were missed. Patients should have secure access to personal assistive devices, such as hearing aids and even smartphones with communication apps (eg, speech-to-text apps) to facilitate interpersonal communication.

Clear Face Masks

Face masks with transparent windows have been developed. Deaf and hard of hearing people’s speech perception increases when speakers use transparent versus conventional masks. The Food and Drug Administration has approved two clear face masks as American Society for Testing Materials Level 1 (Table). These two masks have limited utility for high-risk situations, such as aerosolizing procedures; in such cases, a powered air purifying respirator with a clear viewing window will be needed instead. Notably, clear mask supply has lagged behind demand, creating limited mask availability during the pandemic; their use may need to be restricted to those working with patients with communication-based disabilities.

Tools for Communicating Within the Patient’s Room

Erasable whiteboards and communication boards are useful tools for simple exchanges as long as patients’ literacy and fluency are adequate. “PocketTalkers” or personalized sound amplification products may allow providers to speak into a microphone, providing amplified speech via a patient’s headphones. These amplification products are typically useful for those with mild to moderate hearing loss who are not using a hearing aid. Automatic speech recognition apps are device-based apps for converting speech to text. Speakers hold the device near the mouth to maximize accuracy while the patient reads the captions on their screen. With social distancing, lavalier microphones can increase text accuracy, but higher rates of error may still occur due to background noises or accents. For increased reliability and accuracy, Computer Access Realtime Translation stenographers can provide live speech to text on a computer screen from off-site via a computer or smartphone.

Tools for Isolation-Limited Communication

Team members can call an intermediary service to communicate with the patient via the patient’s smartphone or hospital-provided remote video interpreting service, depending on the patient’s preferred communication modality. For oral and spoken language, some services (Table) use remote stenographers to convert speech to text or sign language interpreters for those who use sign language. For both communication modes, smartphone-based videoconferencing may be beneficial while maintaining isolation precautions.

Interpreter Accessibility

Conceptualize interpreters as consulting healthcare team members. They should receive the same PPE training and monitoring as other healthcare workers. For patients using remote video interpretation, this technology needs to be optimized for best results. The room should be in a location with a strong Wi-Fi signal. Equipment should be consistently charged when not in use and rapidly accessible, even remaining in the patients’ room if possible. Healthcare teams need training to appropriately locate and set up the equipment with appropriate support from information technology staff.

Signage

Signage is useful to remind healthcare teams of the patients’ and/or caregivers’ communication-based disability. The most commonly used disability signage shows a line across an ear to indicate hearing loss (Appendix Figure).²² Appropriate signage use, even simple printed sheets documenting a communication issue, can remind healthcare team members of patients’ needs to ensure that communication is accessible and avoid misconceptions toward the patient (eg, noncompliance or cognitive issues). Chart banners, patient room doorways, and over the patients’ beds are good signage locations.

Systematic Noise Reduction

Consistent with previous calls to reduce inpatient noise,²³ hospitals should systematically review and monitor protocols to reduce noise pollution. If intra-unit noise varies, patients relying on acoustic-based communication due to hearing loss or speech, language, or voice disability should be placed in quieter rooms.

Communication Concordance

Healthcare professionals and staff with disabilities are an increasingly recognized workforce segment,²⁴ and often are experienced innovators in communicating effectively with patients with communication-based disabilities. Healthcare systems can explore whether they have healthcare team members, employees, disability resource professionals, and/or trainees with these backgrounds and, if they are available, recruit them into developing effective inpatient communication policies and processes.

People with communication disabilities experience significant healthcare disparities, now further exacerbated by COVID-19. As clinicians, staff and hospitals work to fuse safety with high-quality communication and care, we should capitalize on multipronged opportunities at the system and individual levels to identify barriers and ensure accessible and effective communication with patients who have communication-based disabilities.

Adults with communication-based disabilities struggle with healthcare inequities,^1-4 largely secondary to poor healthcare provider-patient communication. The prevalence of communication-based disabilities, which include speech, language, voice, and/or hearing disabilities, is relatively high yet difficult to ascertain. Ten percent of adults in the United States report having had a speech, language, or voice disability within the past year,⁵ and hearing loss also affects 17% of the US population.⁶ These individuals’ collective communication difficulties have been exacerbated by the coronavirus disease 2019 (COVID-19) pandemic, with healthcare systems mandating personal protective equipment (PPE), including face masks, to ensure the safety of workers and patients. This change has placed patients with communication-based disabilities at even greater risk for communication breakdowns.^7,8

Hospitals pose challenging communicative environments due to multiple factors (eg, noisy equipment alarms, harried healthcare teams spending less time with patients, PPE use obstructing faces and muffling sounds). Adverse communication among those with communication-based disabilities results in poorer healthcare outcomes, including higher rates of readmission and preventable adverse medical events, as well as lower healthcare satisfaction.^7,9,10 Ineffective communication leads to reduced adherence, longer hospitalizations, and worse health outcomes in general.^11-13 This is problematic because those with communication-based disabilities are more likely to require hospitalization due to higher rates of associated comorbidities, including frailty, cardiovascular disease, cognitive decline, and falls.^4,14-16 Yet hospitals rarely screen and implement best practices to ensure effective and accessible communication for those with communication-based disabilities. The COVID-19 pandemic has exacerbated existing barriers, despite feasible solutions. Importantly, the Americans with Disabilities Act (ADA) remains in effect despite the pandemic. Therefore, hospitals should review existing policies and approaches to ensure adherence to ADA mandates. We address commonly encountered COVID-19-related communication barriers and recommend potential solutions.¹⁷

Limited Time or Support

Patients with communication-based disabilities may need more time than others to communicate their needs, values, and preferences effectively, whether due to slower articulation (eg, movement disorders) or communicating via an intermediary (eg, family member who understands them well) or an interpreter. Due to capacity or patient acuity issues, or even concerns about minimizing time in the room of a patient infected with COVID-19, hospital staff may inadvertently spend less time than needed to develop the necessary therapeutic relationships. This concern is magnified when restrictive visitor policies limit the availability of caregivers, such as loved ones, who assist at the bedside with communication.¹⁸

Universal Masking and Face Shields

Standard face masks, now required for all in-person encounters regardless of the patient’s COVID-19 status, obstruct the view of the lips and many facial expressions. Facial cues are an important form of nonverbal communication and are critical to conveying meaning in sign language. Face masks, particularly N95 respirators, substantially degrade speech perception.¹⁹ Masking increases the difficulty of acoustically and visually understanding patients who have disorders that decrease speech intelligibility, such as dysphonia, dysarthria, or apraxic speech. Environmental noise reduces general speech perception and can be especially problematic for both those struggling with a hearing loss and for healthcare workers trying to understand masked patients with speech or language disorders.²⁰ In addition, transparent face shields along with other eye protection equipment are commonly combined with face masks during encounters with patients with and without COVID-19. These face shields, while generally transparent, further muffle spoken sounds.²¹ Fogging of face shields, often when used with face masks, further impedes appreciation of facial expressions.

Interpreters

For deaf and hard-of-hearing people who use American Sign Language (ASL) as their preferred healthcare communication method, interpreters play a critical role in ensuring accessible healthcare communication. Signed language interpretation can occur in person or remotely by video. For in-person interpretation, interpreters must likewise wear PPE. The use of PPE, including face masks, can obscure many of the facial cues important to ASL grammar. Similarly, patients’ face masks can make it more challenging for interpreters to interpret effectively. With remote video interpretation, technological difficulties (eg, dropped WiFi connections) and the loss of environmental cues (eg, interpreter at a remote location unable to see or hear patient surroundings) often mar opportunities for accessible and effective communication. For the DeafBlind community, the use of remote video interpretation is not feasible. DeafBlind people rely on tactile forms of ASL, requiring interpreters’ physical touch throughout the communication encounter. This potentially increases COVID-19 transmission risk.

While some of the solutions listed below also apply to communication in nonpandemic times, identifying high-risk patients and anticipatory planning for communication has become even more important during the COVID-19 outbreak.

Identification and Assessment of Communication Breakdown Risks

Hospital staff should systematically review admission and transfer protocols to ensure every patient is asked about their communication preferences, necessary accommodations, and specific needs. Any communication needs or accommodation requests (eg, interpreters, communication boards) should be documented and flagged in highly visible areas of the electronic health record. These patients should be assessed regularly to ensure their communication needs are being met and documented throughout their hospital stay.

Assistive Communication Steps

Some steps can be performed in advance. Careful consideration should be given to healthcare providers’ ability to spend additional time with patients with communication-based disabilities. Even if providers are limited physically in the room, they can still work to optimize mindful, high-quality communication by calling into the patient’s room by phone or video. The additional time is important especially when establishing rapport with patients and identifying their preferred communication approaches, as well as engaging their support networks. Patients with communication-based disabilities and their support team often have expertise on their ideal communication strategies. Healthcare providers and staff should inquire about communication preferences. Patients should also be oriented to hospital team structure and members, which could include simple solutions such as legible name tags. Hearing aids, batteries, and other assistive technology should have designated places to prevent loss and ensure ongoing working status. In addition, nurse stations should have a communication toolbox that includes replacement batteries for hearing aids along with other assistive technology devices, such as a personal sound amplification product.

Communication Strategies

Healthcare teams should be trained and reminded to use patient-centered communication strategies, including assessing their comprehension of shared health information through teach-back principles. Strategies vary by patient and may require teams’ flexibility in meeting the patient’s needs and preferences. Examples include ensuring one has the patient’s attention and uses good eye contact. Using a projected “radio voice,” which emphasizes clarity and articulation rather than volume, is helpful for those with hearing loss. For some, meaningful gestures (eg, pointing to one’s own head when asking about headaches) can aid communication. Another strategy when having difficulty understanding patients with decreased speech intelligibility is to repeat the audible speech so that the patient only needs to repeat the inaudible portions that were missed. Patients should have secure access to personal assistive devices, such as hearing aids and even smartphones with communication apps (eg, speech-to-text apps) to facilitate interpersonal communication.

Clear Face Masks

Face masks with transparent windows have been developed. Deaf and hard of hearing people’s speech perception increases when speakers use transparent versus conventional masks. The Food and Drug Administration has approved two clear face masks as American Society for Testing Materials Level 1 (Table). These two masks have limited utility for high-risk situations, such as aerosolizing procedures; in such cases, a powered air purifying respirator with a clear viewing window will be needed instead. Notably, clear mask supply has lagged behind demand, creating limited mask availability during the pandemic; their use may need to be restricted to those working with patients with communication-based disabilities.

Tools for Communicating Within the Patient’s Room

Erasable whiteboards and communication boards are useful tools for simple exchanges as long as patients’ literacy and fluency are adequate. “PocketTalkers” or personalized sound amplification products may allow providers to speak into a microphone, providing amplified speech via a patient’s headphones. These amplification products are typically useful for those with mild to moderate hearing loss who are not using a hearing aid. Automatic speech recognition apps are device-based apps for converting speech to text. Speakers hold the device near the mouth to maximize accuracy while the patient reads the captions on their screen. With social distancing, lavalier microphones can increase text accuracy, but higher rates of error may still occur due to background noises or accents. For increased reliability and accuracy, Computer Access Realtime Translation stenographers can provide live speech to text on a computer screen from off-site via a computer or smartphone.

Tools for Isolation-Limited Communication

Team members can call an intermediary service to communicate with the patient via the patient’s smartphone or hospital-provided remote video interpreting service, depending on the patient’s preferred communication modality. For oral and spoken language, some services (Table) use remote stenographers to convert speech to text or sign language interpreters for those who use sign language. For both communication modes, smartphone-based videoconferencing may be beneficial while maintaining isolation precautions.

Interpreter Accessibility

Conceptualize interpreters as consulting healthcare team members. They should receive the same PPE training and monitoring as other healthcare workers. For patients using remote video interpretation, this technology needs to be optimized for best results. The room should be in a location with a strong Wi-Fi signal. Equipment should be consistently charged when not in use and rapidly accessible, even remaining in the patients’ room if possible. Healthcare teams need training to appropriately locate and set up the equipment with appropriate support from information technology staff.

Signage

Signage is useful to remind healthcare teams of the patients’ and/or caregivers’ communication-based disability. The most commonly used disability signage shows a line across an ear to indicate hearing loss (Appendix Figure).²² Appropriate signage use, even simple printed sheets documenting a communication issue, can remind healthcare team members of patients’ needs to ensure that communication is accessible and avoid misconceptions toward the patient (eg, noncompliance or cognitive issues). Chart banners, patient room doorways, and over the patients’ beds are good signage locations.

Systematic Noise Reduction

Consistent with previous calls to reduce inpatient noise,²³ hospitals should systematically review and monitor protocols to reduce noise pollution. If intra-unit noise varies, patients relying on acoustic-based communication due to hearing loss or speech, language, or voice disability should be placed in quieter rooms.

Communication Concordance

Healthcare professionals and staff with disabilities are an increasingly recognized workforce segment,²⁴ and often are experienced innovators in communicating effectively with patients with communication-based disabilities. Healthcare systems can explore whether they have healthcare team members, employees, disability resource professionals, and/or trainees with these backgrounds and, if they are available, recruit them into developing effective inpatient communication policies and processes.

People with communication disabilities experience significant healthcare disparities, now further exacerbated by COVID-19. As clinicians, staff and hospitals work to fuse safety with high-quality communication and care, we should capitalize on multipronged opportunities at the system and individual levels to identify barriers and ensure accessible and effective communication with patients who have communication-based disabilities.

Adults with communication-based disabilities struggle with healthcare inequities,^1-4 largely secondary to poor healthcare provider-patient communication. The prevalence of communication-based disabilities, which include speech, language, voice, and/or hearing disabilities, is relatively high yet difficult to ascertain. Ten percent of adults in the United States report having had a speech, language, or voice disability within the past year,⁵ and hearing loss also affects 17% of the US population.⁶ These individuals’ collective communication difficulties have been exacerbated by the coronavirus disease 2019 (COVID-19) pandemic, with healthcare systems mandating personal protective equipment (PPE), including face masks, to ensure the safety of workers and patients. This change has placed patients with communication-based disabilities at even greater risk for communication breakdowns.^7,8

Hospitals pose challenging communicative environments due to multiple factors (eg, noisy equipment alarms, harried healthcare teams spending less time with patients, PPE use obstructing faces and muffling sounds). Adverse communication among those with communication-based disabilities results in poorer healthcare outcomes, including higher rates of readmission and preventable adverse medical events, as well as lower healthcare satisfaction.^7,9,10 Ineffective communication leads to reduced adherence, longer hospitalizations, and worse health outcomes in general.^11-13 This is problematic because those with communication-based disabilities are more likely to require hospitalization due to higher rates of associated comorbidities, including frailty, cardiovascular disease, cognitive decline, and falls.^4,14-16 Yet hospitals rarely screen and implement best practices to ensure effective and accessible communication for those with communication-based disabilities. The COVID-19 pandemic has exacerbated existing barriers, despite feasible solutions. Importantly, the Americans with Disabilities Act (ADA) remains in effect despite the pandemic. Therefore, hospitals should review existing policies and approaches to ensure adherence to ADA mandates. We address commonly encountered COVID-19-related communication barriers and recommend potential solutions.¹⁷

Limited Time or Support

Patients with communication-based disabilities may need more time than others to communicate their needs, values, and preferences effectively, whether due to slower articulation (eg, movement disorders) or communicating via an intermediary (eg, family member who understands them well) or an interpreter. Due to capacity or patient acuity issues, or even concerns about minimizing time in the room of a patient infected with COVID-19, hospital staff may inadvertently spend less time than needed to develop the necessary therapeutic relationships. This concern is magnified when restrictive visitor policies limit the availability of caregivers, such as loved ones, who assist at the bedside with communication.¹⁸

Universal Masking and Face Shields

Standard face masks, now required for all in-person encounters regardless of the patient’s COVID-19 status, obstruct the view of the lips and many facial expressions. Facial cues are an important form of nonverbal communication and are critical to conveying meaning in sign language. Face masks, particularly N95 respirators, substantially degrade speech perception.¹⁹ Masking increases the difficulty of acoustically and visually understanding patients who have disorders that decrease speech intelligibility, such as dysphonia, dysarthria, or apraxic speech. Environmental noise reduces general speech perception and can be especially problematic for both those struggling with a hearing loss and for healthcare workers trying to understand masked patients with speech or language disorders.²⁰ In addition, transparent face shields along with other eye protection equipment are commonly combined with face masks during encounters with patients with and without COVID-19. These face shields, while generally transparent, further muffle spoken sounds.²¹ Fogging of face shields, often when used with face masks, further impedes appreciation of facial expressions.

Interpreters

For deaf and hard-of-hearing people who use American Sign Language (ASL) as their preferred healthcare communication method, interpreters play a critical role in ensuring accessible healthcare communication. Signed language interpretation can occur in person or remotely by video. For in-person interpretation, interpreters must likewise wear PPE. The use of PPE, including face masks, can obscure many of the facial cues important to ASL grammar. Similarly, patients’ face masks can make it more challenging for interpreters to interpret effectively. With remote video interpretation, technological difficulties (eg, dropped WiFi connections) and the loss of environmental cues (eg, interpreter at a remote location unable to see or hear patient surroundings) often mar opportunities for accessible and effective communication. For the DeafBlind community, the use of remote video interpretation is not feasible. DeafBlind people rely on tactile forms of ASL, requiring interpreters’ physical touch throughout the communication encounter. This potentially increases COVID-19 transmission risk.

While some of the solutions listed below also apply to communication in nonpandemic times, identifying high-risk patients and anticipatory planning for communication has become even more important during the COVID-19 outbreak.

Identification and Assessment of Communication Breakdown Risks

Hospital staff should systematically review admission and transfer protocols to ensure every patient is asked about their communication preferences, necessary accommodations, and specific needs. Any communication needs or accommodation requests (eg, interpreters, communication boards) should be documented and flagged in highly visible areas of the electronic health record. These patients should be assessed regularly to ensure their communication needs are being met and documented throughout their hospital stay.

Assistive Communication Steps

Some steps can be performed in advance. Careful consideration should be given to healthcare providers’ ability to spend additional time with patients with communication-based disabilities. Even if providers are limited physically in the room, they can still work to optimize mindful, high-quality communication by calling into the patient’s room by phone or video. The additional time is important especially when establishing rapport with patients and identifying their preferred communication approaches, as well as engaging their support networks. Patients with communication-based disabilities and their support team often have expertise on their ideal communication strategies. Healthcare providers and staff should inquire about communication preferences. Patients should also be oriented to hospital team structure and members, which could include simple solutions such as legible name tags. Hearing aids, batteries, and other assistive technology should have designated places to prevent loss and ensure ongoing working status. In addition, nurse stations should have a communication toolbox that includes replacement batteries for hearing aids along with other assistive technology devices, such as a personal sound amplification product.

Communication Strategies

Healthcare teams should be trained and reminded to use patient-centered communication strategies, including assessing their comprehension of shared health information through teach-back principles. Strategies vary by patient and may require teams’ flexibility in meeting the patient’s needs and preferences. Examples include ensuring one has the patient’s attention and uses good eye contact. Using a projected “radio voice,” which emphasizes clarity and articulation rather than volume, is helpful for those with hearing loss. For some, meaningful gestures (eg, pointing to one’s own head when asking about headaches) can aid communication. Another strategy when having difficulty understanding patients with decreased speech intelligibility is to repeat the audible speech so that the patient only needs to repeat the inaudible portions that were missed. Patients should have secure access to personal assistive devices, such as hearing aids and even smartphones with communication apps (eg, speech-to-text apps) to facilitate interpersonal communication.

Clear Face Masks

Face masks with transparent windows have been developed. Deaf and hard of hearing people’s speech perception increases when speakers use transparent versus conventional masks. The Food and Drug Administration has approved two clear face masks as American Society for Testing Materials Level 1 (Table). These two masks have limited utility for high-risk situations, such as aerosolizing procedures; in such cases, a powered air purifying respirator with a clear viewing window will be needed instead. Notably, clear mask supply has lagged behind demand, creating limited mask availability during the pandemic; their use may need to be restricted to those working with patients with communication-based disabilities.

Tools for Communicating Within the Patient’s Room

Erasable whiteboards and communication boards are useful tools for simple exchanges as long as patients’ literacy and fluency are adequate. “PocketTalkers” or personalized sound amplification products may allow providers to speak into a microphone, providing amplified speech via a patient’s headphones. These amplification products are typically useful for those with mild to moderate hearing loss who are not using a hearing aid. Automatic speech recognition apps are device-based apps for converting speech to text. Speakers hold the device near the mouth to maximize accuracy while the patient reads the captions on their screen. With social distancing, lavalier microphones can increase text accuracy, but higher rates of error may still occur due to background noises or accents. For increased reliability and accuracy, Computer Access Realtime Translation stenographers can provide live speech to text on a computer screen from off-site via a computer or smartphone.

Tools for Isolation-Limited Communication

Team members can call an intermediary service to communicate with the patient via the patient’s smartphone or hospital-provided remote video interpreting service, depending on the patient’s preferred communication modality. For oral and spoken language, some services (Table) use remote stenographers to convert speech to text or sign language interpreters for those who use sign language. For both communication modes, smartphone-based videoconferencing may be beneficial while maintaining isolation precautions.

Interpreter Accessibility

Conceptualize interpreters as consulting healthcare team members. They should receive the same PPE training and monitoring as other healthcare workers. For patients using remote video interpretation, this technology needs to be optimized for best results. The room should be in a location with a strong Wi-Fi signal. Equipment should be consistently charged when not in use and rapidly accessible, even remaining in the patients’ room if possible. Healthcare teams need training to appropriately locate and set up the equipment with appropriate support from information technology staff.

Signage

Signage is useful to remind healthcare teams of the patients’ and/or caregivers’ communication-based disability. The most commonly used disability signage shows a line across an ear to indicate hearing loss (Appendix Figure).²² Appropriate signage use, even simple printed sheets documenting a communication issue, can remind healthcare team members of patients’ needs to ensure that communication is accessible and avoid misconceptions toward the patient (eg, noncompliance or cognitive issues). Chart banners, patient room doorways, and over the patients’ beds are good signage locations.

Systematic Noise Reduction

Consistent with previous calls to reduce inpatient noise,²³ hospitals should systematically review and monitor protocols to reduce noise pollution. If intra-unit noise varies, patients relying on acoustic-based communication due to hearing loss or speech, language, or voice disability should be placed in quieter rooms.

Communication Concordance

Healthcare professionals and staff with disabilities are an increasingly recognized workforce segment,²⁴ and often are experienced innovators in communicating effectively with patients with communication-based disabilities. Healthcare systems can explore whether they have healthcare team members, employees, disability resource professionals, and/or trainees with these backgrounds and, if they are available, recruit them into developing effective inpatient communication policies and processes.

People with communication disabilities experience significant healthcare disparities, now further exacerbated by COVID-19. As clinicians, staff and hospitals work to fuse safety with high-quality communication and care, we should capitalize on multipronged opportunities at the system and individual levels to identify barriers and ensure accessible and effective communication with patients who have communication-based disabilities.

An increasingly common question I’m receiving is: What should private practices do if a patient or employee tests positive for COVID-19, or has been exposed to someone who has?

As always, it depends, but here is some general advice: The specifics will vary depending on state/local laws, or your particular situation.

First, you need to determine the level of exposure, and whether it requires action. According to the Centers for Disease Control and Prevention, actionable exposure occurs 2 days prior to the onset of illness, and lasts 10 days after onset.

If action is required, you’ll need to determine who needs to quarantine and who needs to be tested. Vaccinated employees who have been exposed to suspected or confirmed COVID-19 are not required to quarantine or be tested if they are fully vaccinated and have remained asymptomatic since the exposure. Those employees should, however, follow all the usual precautions (masks, social distancing, handwashing, etc.) with increased diligence. Remind them that no vaccine is 100% effective, and suggest they self-monitor for symptoms (fever, cough, shortness of breath, etc.)

All other exposed employees should be tested. A negative test means an individual was not infected at the time the sample was collected, but that does not mean an individual will not get sick later. Some providers are retesting on days 5 and 7 post exposure.

Some experts advise that you monitor exposed employees (vaccinated or not) yourself, with daily temperature readings and inquiries regarding symptoms, and perhaps a daily pulse oximetry check, for 14 days following exposure. Document these screenings in writing. Anyone testing positive or developing a fever or other symptoms should, of course, be sent home and seek medical treatment as necessary.

Employees who develop symptoms or test positive for COVID-19 should remain out of work until all CDC “return-to-work” criteria are met. At this writing, the basic criteria include:

• At least 10 days pass after symptoms first appeared
• At least 24 hours pass after last fever without the use of fever-reducing medications
• Cough, shortness of breath, and any other symptoms improve

Anyone who is significantly immunocompromised may need more time at home, and probably consultation with an infectious disease specialist.

Your facility should be thoroughly cleaned after the exposure. Close off all areas used by the sick individual, and clean and disinfect all areas such as offices, doorknobs, bathrooms, common areas, and shared electronic equipment. Of course, the cleaners should wear gowns, gloves, masks, and goggles. Some practices are hiring cleaning crews to professionally disinfect their offices. Once the area has been disinfected, it can be reopened for use. Workers without close contact with the person who is sick can return to work immediately after disinfection.

If the potential infected area is widespread and cannot be isolated to a room or rooms where doors can be shut, it may be prudent to temporarily close your office, send staff home, and divert patients to other locations if they cannot be rescheduled. Once your facility is cleaned and disinfected and staff have been cleared, your office may reopen.

Use enhanced precautions for any staff or patients who are immunocompromised, or otherwise fall into the high-risk category, to keep them out of the path of potential exposure areas and allow them to self-quarantine if they desire.

You should continue following existing leave policies (paid time off, vacation, sick, short-term disability, leave of absence, Family and Medical Leave Act, and Americans with Disabilities Act). If the employee was exposed at work, contact your workers’ compensation carrier regarding lost wages. Unless your state laws specify otherwise, you are under no obligation to pay beyond your policies, but you may do so if you choose.

Of course, you can take proactive steps to prevent unnecessary exposure and avoid closures in the first place; for example:

• Call patients prior to their visit, or question them upon arrival, regarding fever, shortness of breath, and other COVID-19 symptoms.
• Check employees’ temperatures every morning.
• Check patients’ temperatures as they enter the office.
• Require everyone, patients and employees alike, to wear face coverings.
• Ask patients to leave friends and family members at home.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at [email protected].

An increasingly common question I’m receiving is: What should private practices do if a patient or employee tests positive for COVID-19, or has been exposed to someone who has?

As always, it depends, but here is some general advice: The specifics will vary depending on state/local laws, or your particular situation.

First, you need to determine the level of exposure, and whether it requires action. According to the Centers for Disease Control and Prevention, actionable exposure occurs 2 days prior to the onset of illness, and lasts 10 days after onset.

If action is required, you’ll need to determine who needs to quarantine and who needs to be tested. Vaccinated employees who have been exposed to suspected or confirmed COVID-19 are not required to quarantine or be tested if they are fully vaccinated and have remained asymptomatic since the exposure. Those employees should, however, follow all the usual precautions (masks, social distancing, handwashing, etc.) with increased diligence. Remind them that no vaccine is 100% effective, and suggest they self-monitor for symptoms (fever, cough, shortness of breath, etc.)

All other exposed employees should be tested. A negative test means an individual was not infected at the time the sample was collected, but that does not mean an individual will not get sick later. Some providers are retesting on days 5 and 7 post exposure.

Some experts advise that you monitor exposed employees (vaccinated or not) yourself, with daily temperature readings and inquiries regarding symptoms, and perhaps a daily pulse oximetry check, for 14 days following exposure. Document these screenings in writing. Anyone testing positive or developing a fever or other symptoms should, of course, be sent home and seek medical treatment as necessary.

Employees who develop symptoms or test positive for COVID-19 should remain out of work until all CDC “return-to-work” criteria are met. At this writing, the basic criteria include:

• At least 10 days pass after symptoms first appeared
• At least 24 hours pass after last fever without the use of fever-reducing medications
• Cough, shortness of breath, and any other symptoms improve

Anyone who is significantly immunocompromised may need more time at home, and probably consultation with an infectious disease specialist.

Your facility should be thoroughly cleaned after the exposure. Close off all areas used by the sick individual, and clean and disinfect all areas such as offices, doorknobs, bathrooms, common areas, and shared electronic equipment. Of course, the cleaners should wear gowns, gloves, masks, and goggles. Some practices are hiring cleaning crews to professionally disinfect their offices. Once the area has been disinfected, it can be reopened for use. Workers without close contact with the person who is sick can return to work immediately after disinfection.

If the potential infected area is widespread and cannot be isolated to a room or rooms where doors can be shut, it may be prudent to temporarily close your office, send staff home, and divert patients to other locations if they cannot be rescheduled. Once your facility is cleaned and disinfected and staff have been cleared, your office may reopen.

Use enhanced precautions for any staff or patients who are immunocompromised, or otherwise fall into the high-risk category, to keep them out of the path of potential exposure areas and allow them to self-quarantine if they desire.

You should continue following existing leave policies (paid time off, vacation, sick, short-term disability, leave of absence, Family and Medical Leave Act, and Americans with Disabilities Act). If the employee was exposed at work, contact your workers’ compensation carrier regarding lost wages. Unless your state laws specify otherwise, you are under no obligation to pay beyond your policies, but you may do so if you choose.

Of course, you can take proactive steps to prevent unnecessary exposure and avoid closures in the first place; for example:

• Call patients prior to their visit, or question them upon arrival, regarding fever, shortness of breath, and other COVID-19 symptoms.
• Check employees’ temperatures every morning.
• Check patients’ temperatures as they enter the office.
• Require everyone, patients and employees alike, to wear face coverings.
• Ask patients to leave friends and family members at home.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at [email protected].

An increasingly common question I’m receiving is: What should private practices do if a patient or employee tests positive for COVID-19, or has been exposed to someone who has?

As always, it depends, but here is some general advice: The specifics will vary depending on state/local laws, or your particular situation.

First, you need to determine the level of exposure, and whether it requires action. According to the Centers for Disease Control and Prevention, actionable exposure occurs 2 days prior to the onset of illness, and lasts 10 days after onset.

If action is required, you’ll need to determine who needs to quarantine and who needs to be tested. Vaccinated employees who have been exposed to suspected or confirmed COVID-19 are not required to quarantine or be tested if they are fully vaccinated and have remained asymptomatic since the exposure. Those employees should, however, follow all the usual precautions (masks, social distancing, handwashing, etc.) with increased diligence. Remind them that no vaccine is 100% effective, and suggest they self-monitor for symptoms (fever, cough, shortness of breath, etc.)

All other exposed employees should be tested. A negative test means an individual was not infected at the time the sample was collected, but that does not mean an individual will not get sick later. Some providers are retesting on days 5 and 7 post exposure.

Some experts advise that you monitor exposed employees (vaccinated or not) yourself, with daily temperature readings and inquiries regarding symptoms, and perhaps a daily pulse oximetry check, for 14 days following exposure. Document these screenings in writing. Anyone testing positive or developing a fever or other symptoms should, of course, be sent home and seek medical treatment as necessary.

Employees who develop symptoms or test positive for COVID-19 should remain out of work until all CDC “return-to-work” criteria are met. At this writing, the basic criteria include:

• At least 10 days pass after symptoms first appeared
• At least 24 hours pass after last fever without the use of fever-reducing medications
• Cough, shortness of breath, and any other symptoms improve

Anyone who is significantly immunocompromised may need more time at home, and probably consultation with an infectious disease specialist.

Your facility should be thoroughly cleaned after the exposure. Close off all areas used by the sick individual, and clean and disinfect all areas such as offices, doorknobs, bathrooms, common areas, and shared electronic equipment. Of course, the cleaners should wear gowns, gloves, masks, and goggles. Some practices are hiring cleaning crews to professionally disinfect their offices. Once the area has been disinfected, it can be reopened for use. Workers without close contact with the person who is sick can return to work immediately after disinfection.

If the potential infected area is widespread and cannot be isolated to a room or rooms where doors can be shut, it may be prudent to temporarily close your office, send staff home, and divert patients to other locations if they cannot be rescheduled. Once your facility is cleaned and disinfected and staff have been cleared, your office may reopen.

Use enhanced precautions for any staff or patients who are immunocompromised, or otherwise fall into the high-risk category, to keep them out of the path of potential exposure areas and allow them to self-quarantine if they desire.

You should continue following existing leave policies (paid time off, vacation, sick, short-term disability, leave of absence, Family and Medical Leave Act, and Americans with Disabilities Act). If the employee was exposed at work, contact your workers’ compensation carrier regarding lost wages. Unless your state laws specify otherwise, you are under no obligation to pay beyond your policies, but you may do so if you choose.

Of course, you can take proactive steps to prevent unnecessary exposure and avoid closures in the first place; for example:

• Call patients prior to their visit, or question them upon arrival, regarding fever, shortness of breath, and other COVID-19 symptoms.
• Check employees’ temperatures every morning.
• Check patients’ temperatures as they enter the office.
• Require everyone, patients and employees alike, to wear face coverings.
• Ask patients to leave friends and family members at home.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at [email protected].

Nearly 60% of those working in a large health care system expressed their intent to roll up their sleeves to receive the COVID-19 vaccine, but about one-third were unsure of doing so.

Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.

The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.

“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”

For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.

Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.

Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.

Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).

The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).

“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
 

A focus on rebuilding trust

Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).

“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”

The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).

“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”

Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
 

Addressing vaccine hesitancy

Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.

In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.

Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”

The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.

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

Nearly 60% of those working in a large health care system expressed their intent to roll up their sleeves to receive the COVID-19 vaccine, but about one-third were unsure of doing so.

Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.

The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.

“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”

For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.

Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.

Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.

Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).

The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).

“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
 

A focus on rebuilding trust

Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).

“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”

The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).

“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”

Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
 

Addressing vaccine hesitancy

Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.

In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.

Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”

The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.

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

Nearly 60% of those working in a large health care system expressed their intent to roll up their sleeves to receive the COVID-19 vaccine, but about one-third were unsure of doing so.

Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.

The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.

“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”

For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.

Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.

Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.

Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).

The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).

“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
 

A focus on rebuilding trust

Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).

“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”

The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).

“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”

Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
 

Addressing vaccine hesitancy

Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.

In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.

Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”

The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.

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