Mixed Topics

Recent advances in our understanding of psoriatic immune pathways have led to new generations of targeted therapies developed over the last 5 years. Although the pathogenesis of psoriasis remains to be fully elucidated, the success of these targeted therapies has confirmed a critical role of the IL-23/helper T cell (T_H17) axis in maintaining the psoriatic immune cascade, a positive feedback loop in which IL-17, IL-12, and IL-23 released from myeloid dendritic cells lead to activation of helperT cells. Activated helper T cells—namely T_H1, T_H17, and T_H22—release IL-17, IL-22, and other proinflammatory cytokines, amplifying the immune response and leading to keratinocyte proliferation and immune cell migration to psoriatic lesions. Inhibition of IL-17 and IL-23 by several biologics disrupts this aberrant inflammatory cascade and has led to dramatic improvements in outcomes, particularly among patients with moderate to severe disease.

Numerous biologics targeting these pathways and several oral treatments have been approved by the US Food and Drug Administration (FDA) for the treatment of psoriasis; in addition, a number of promising therapies are on the horizon, and knowledge of these medications might help guide our treatment approach to the patient with psoriasis. This article provides an update on the most recent (as of 2019) approved therapies and medications in the pipeline for moderate to severe plaque psoriasis, with a focus on systemic agents in phase 3 clinical trials. (Medications targeting psoriatic arthritis, biosimilars, and existing medications approved by the FDA prior to 2019 will not be discussed.)

Risankizumab

Risankizumab-rzaa (formerly BI 655066) is a humanized IgG1 monoclonal antibody that targets the p19 subunit of IL-23, selectively inhibiting the role of this critical cytokine in psoriatic inflammation.

Phase 1 Trial
In a phase 1 proof-of-concept study, 39 patients with moderate to severe plaque psoriasis received varying dosages of intravenous or subcutaneous risankizumab or placebo.¹ At week 12, the percentage of risankizumab-treated patients achieving reduction in the psoriasis area and severity index (PASI) score by 75% (PASI 75), 90% (PASI 90), and 100% (PASI 100) was 87% (27/31; P<.001 vs placebo), 58% (18/31; P=.007 vs placebo), and 16% (5/31; P=.590 vs placebo), respectively. Improvements in PASI scores were observed as early as week 2. Adverse events (AEs) were reported by 65% of the risankizumab group and 88% of the placebo group. Serious AEs were reported in 4 patients receiving risankizumab, none of which were considered related to the study medication.¹

Phase 2 Trial
A phase 2 comparator trial demonstrated noninferiority at higher dosages of risankizumab in comparison to the IL-12/IL-23 inhibitor ustekinumab.² Among 166 participants with moderate to severe plaque psoriasis, PASI 90 at week 12 was met by 77% of participants receiving 90 or 180 mg of risankizumab compared to 40% receiving ustekinumab (P<.001). Onset of activity with risankizumab was faster and the duration of effect longer vs ustekinumab; by week 8, at least PASI 75 was achieved by approximately 80% of participants in the 90-mg and 180-mg risankizumab groups compared to 60% in the ustekinumab group; PASI score reductions generally were maintained for as long as 20 weeks after the final dose of risankizumab was administered.²

Phase 3 Trials
The 52-week UltIMMa-1 and UltIMMa-2 phase 3 trials compared subcutaneous risankizumab (150 mg) to ustekinumab (45 or 90 mg [weight-based dosing]) or placebo administered at weeks 0, 4, 16, 28, and 40 in approximately 1000 patients with moderate to severe plaque psoriasis.³ Patients initially assigned to placebo switched to risankizumab 150 mg at week 16. At week 16, PASI 90 was achieved by 75.3% of risankizumab-treated patients, 42.0% of ustekinumab-treated patients, and 4.9% of placebo-treated patients in UltIMMa-1, and by 74.8% of risankizumab-treated patients, 47.5% of ustekinumab-treated patients, and 2.0% of placebo-treated patients in UltIMMa-2 (P<.0001 vs placebo and ustekinumab for both studies). Achievement of a static physician’s global assessment (sPGA) score of 0 or 1 at week 16 similarly favored risankizumab, with 87.8%, 63.0%, and 7.8% of patients in UltIMMa-1 meeting an sPGA score of 0 or 1 in the risankizumab, ustekinumab, and placebo groups, respectively, and 83.7%, 61.6%, and 5.1% in UltIMMa-2 meeting an sPGA score of 0 or 1 in the risankizumab, ustekinumab, and placebo groups, respectively (P<.0001 vs placebo and ustekinumab for both studies). Among patients initially assigned to risankizumab, improvements in PASI and sPGA continued to increase until week 52, with 81.9% achieving PASI 90 at week 52 compared to 44.0% on ustekinumab in UltIMMa-1, and 80.6% achieving PASI 90 at week 52 compared to 50.5% on ustekinumab in UltIMMa-2 (P<.0001 vs ustekinumab for both studies). Treatment-emergent AE profiles were similar for risankizumab and ustekinumab in both studies, and there were no unexpected safety findings.³

Risankizumab received FDA approval for the treatment of moderate to severe plaque psoriasis in April 2019.

Bimekizumab

Bimekizumab (UCB4940), a humanized IgG1 monoclonal antibody, selectively neutralizes the biologic functions of IL-17A and IL-17F, the latter of which has only recently been implicated in contributing to the psoriatic immune cascade.⁴

First-in-Human Study
Thirty-nine participants with mild psoriasis demonstrated efficacy after single-dose intravenous bimekizumab, with maximal improvements in all measures of disease activity observed between weeks 8 and 12 in participants receiving 160 to 640 mg.⁵

Proof-of-Concept Phase 1b Study
A subsequent trial of 53 participants with psoriatic arthritis demonstrated sustained efficacy to week 20 with varying dosages of intravenous bimekizumab.⁶ At week 8, PASI 100 was met by 86.7% of participants receiving the top 3 dosages of bimekizumab compared to none of the placebo-treated participants. Treatment-emergent AEs, including neutropenia and elevation of liver transaminases, were mostly mild to moderate and resolved spontaneously. There were 3 severe AEs and 3 serious AEs, none of which were related to treatment.⁶

Importantly, bimekizumab was shown in this small study to have the potential to be highly effective at treating psoriatic arthritis. American College of Rheumatology ACR20, ACR50, and ACR70 response criteria were very high, with an ACR20 of 80% and an ACR50 of 40%.⁶ Further trials are necessary to gather more data and confirm these findings; however, these levels of response are higher than those of any other biologic on the market.

Phase 2b Dose-Ranging Study
In this trial, 250 participants with moderate to severe plaque psoriasis received either 64 mg, 160 mg with a 320-mg loading dose, 320 mg, or 480 mg of subcutaneous bimekizumab or placebo at weeks 0, 4, and 8.⁷ At week 12, PASI 90 was achieved by significantly more patients in all bimekizumab-treated groups compared to the placebo group (46.2%–79.1% vs 0%; P<.0001 for all dosages); PASI 100 also was achieved by significantly more bimekizumab-treated patients (27.9%–60.0% vs 0%; P<.0002). Improvement began as early as week 4, with clinically meaningful responses observed in all bimekizumab groups across all measures of disease activity. Treatment-emergent AEs occurred more frequently in bimekizumab-treated participants (61%) than in placebo-treated participants (36%); the most common AEs were nasopharyngitis and upper respiratory tract infection. Of note, fungal infections were reported by 4.3% of participants receiving bimekizumab; all cases were localized superficial infection, and none led to discontinuation. Three serious AEs were reported, none of which were considered related to the study treatment.⁷

Mirikizumab

Mirikizumab (LY3074828) is a humanized IgG4 monoclonal antibody that selectively binds and inhibits the p19 subunit of IL-23, with no action on IL-12.

Phase 1 Trial
Mirikizumab was shown to improve PASI scores in patients with plaque psoriasis.⁸

Phase 2 Trial
Subsequently, a trial of 205 participants with moderate to severe plaque psoriasis compared 3 dosing regimens of subcutaneous mirikizumab—30, 100, or 300 mg—at weeks 0 and 8 compared to placebo.⁹ Primary end point results at week 16 demonstrated PASI 90 response rates of 0%, 29% (P=.009), 59% (P<.001), and 67% (P<.001) in the placebo, 30-mg, 100-mg, and 300-mg mirikizumab groups, respectively. Complete clearance of psoriasis, measured by PASI 100 and sPGA 0, was achieved by 0%, 16%, 31%, and 31%, respectively (P=.039 for 30 mg vs placebo; P=.007 for the higher dosage groups vs placebo). Response rates for all efficacy outcomes were statistically significantly higher for all mirikizumab treatment groups compared to placebo and were highest in the 100-mg and 300-mg treatment groups. Frequencies of participants reporting AEs were similar across treatment and placebo groups.⁹

Oral Medications

Only a few small-molecule, orally bioavailable therapies are on the market for the treatment of psoriasis, some of which are associated with unfavorable side-effect profiles that preclude long-term therapy.

BMS-986165
The intracellular signaling enzyme tyrosine kinase 2 is involved in functional responses of IL-12 and IL-23. BMS-986165, a potent oral inhibitor of tyrosine kinase 2 with greater selectivity than other tyrosine kinase inhibitors, demonstrated efficacy in a phase 2 trial of 267 participants with moderate to severe plaque psoriasis receiving any of 5 dosing regimens—3 mg every other day, 3 mg daily, 3 mg twice daily, 6 mg twice daily, and 12 mg daily—compared to placebo.¹⁰ At week 12, the percentage of patients with a 75% or greater reduction in PASI was 7% with placebo, 9% with 3 mg every other day (P=.49 vs placebo), 39% with 3 mg daily (P<.001 vs placebo), 69% with 3 mg twice daily (P<.001 vs placebo), 67% with 6 mg twice daily (P<.001 vs placebo), and 75% with 12 mg once daily (P<.001 vs placebo). Adverse events occurred in 51% of patients in the placebo group and in 55% to 80% of BMS-986165–treated patients; the most common AEs were nasopharyngitis, headache, diarrhea, nausea, and upper respiratory tract infection.¹⁰

A phase 3 trial comparing BMS-986165 with placebo and apremilast is underway (ClinicalTrials.gov Identifier NCT03611751).

Piclidenoson (CF101)
A novel small molecule that binds the Gi protein–associated A₃ adenosine receptor piclidenoson induces an anti-inflammatory response via deregulation of the Wnt and nuclear factor κB signal transduction pathways, leading to downregulation of proinflammatory cytokines, including IL-17 and IL-23.¹¹

In a phase 2 dose-ranging study, 75 patients with moderate to severe plaque psoriasis received varying dosages—1, 2, or 4 mg—of oral piclidenoson or placebo twice daily for 12 weeks.¹² Progressive improvement in the mean change from baseline PASI score was observed in the 2-mg group, with statistically significant differences at weeks 8 and 12 compared to placebo (P=.047 and P=.031, respectively). At week 12, 35.3% of the 2-mg group achieved at least PASI 50. Improvements in PASI were less pronounced in the 4-mg group, and no therapeutic benefit was observed in the 1-mg group. Of the 20 AEs reported, 15 possibly were related to the study drug; 1 AE was severe.¹²

In a subsequent phase 2/3 trial, patients with moderate to severe plaque psoriasis received piclidenoson—1 or 2 mg—or placebo twice daily.¹³ At week 12, PASI 75 was achieved by 8.5% of patients in the 2-mg group and by 6.9% of patients receiving placebo (P=.621), thereby not meeting the primary study end point. Results at week 32 were more encouraging. In the 2-mg group, PASI mean percentage improvement was 57% (P<.002) compared to baseline, with linear improvements observed in PASI 50 (63.5%), PASI 75 (35.5%), PASI 90 (24.7%), and PASI 100 (10.6%).¹³

A phase 3 trial comparing piclidenoson 2 and 3 mg to apremilast and placebo is in progress (ClinicalTrials.gov Identifier NCT03168256).

Future Directions

Despite abundant options for treating moderate to severe plaque psoriasis and psoriatic arthritis, the pipeline remains rich. Novel treatments might have improved efficacy, favorable safety profiles, and different modes of administration compared to current medications. In addition to the novel therapeutics covered here, several treatments are in development further down the pipeline, with only phase 1 or 2 data available. Remtolumab (ABT-122), a tumor necrosis factor α– and IL-17A–targeted immunoglobulin, is unique among biologics, given its dual inhibition of tumor necrosis factor α and IL-17A.¹⁴ M1095 (ALX-0761), a novel trivalent bispecific nanobody, is another intriguing candidate. This dual inhibitor of IL-17A/F might exhibit a number of advantages over conventional antibodies, including better tissue penetration, reduced immunogenicity, and a longer half-life (ClinicalTrials.gov Identifier NCT03384745).^15,16

As always with drug development, numerous medications that were under development failed to meet primary end points in phase 2 trials and have therefore been discontinued, including namilumab and prurisol. It is reassuring that the pace of drug discovery and development in psoriasis does not seem to be slowing; to our patients’ benefit, we will have an array of treatments available to tailor therapy to the individual.

Recent advances in our understanding of psoriatic immune pathways have led to new generations of targeted therapies developed over the last 5 years. Although the pathogenesis of psoriasis remains to be fully elucidated, the success of these targeted therapies has confirmed a critical role of the IL-23/helper T cell (T_H17) axis in maintaining the psoriatic immune cascade, a positive feedback loop in which IL-17, IL-12, and IL-23 released from myeloid dendritic cells lead to activation of helperT cells. Activated helper T cells—namely T_H1, T_H17, and T_H22—release IL-17, IL-22, and other proinflammatory cytokines, amplifying the immune response and leading to keratinocyte proliferation and immune cell migration to psoriatic lesions. Inhibition of IL-17 and IL-23 by several biologics disrupts this aberrant inflammatory cascade and has led to dramatic improvements in outcomes, particularly among patients with moderate to severe disease.

Numerous biologics targeting these pathways and several oral treatments have been approved by the US Food and Drug Administration (FDA) for the treatment of psoriasis; in addition, a number of promising therapies are on the horizon, and knowledge of these medications might help guide our treatment approach to the patient with psoriasis. This article provides an update on the most recent (as of 2019) approved therapies and medications in the pipeline for moderate to severe plaque psoriasis, with a focus on systemic agents in phase 3 clinical trials. (Medications targeting psoriatic arthritis, biosimilars, and existing medications approved by the FDA prior to 2019 will not be discussed.)

Risankizumab

Risankizumab-rzaa (formerly BI 655066) is a humanized IgG1 monoclonal antibody that targets the p19 subunit of IL-23, selectively inhibiting the role of this critical cytokine in psoriatic inflammation.

Phase 1 Trial
In a phase 1 proof-of-concept study, 39 patients with moderate to severe plaque psoriasis received varying dosages of intravenous or subcutaneous risankizumab or placebo.¹ At week 12, the percentage of risankizumab-treated patients achieving reduction in the psoriasis area and severity index (PASI) score by 75% (PASI 75), 90% (PASI 90), and 100% (PASI 100) was 87% (27/31; P<.001 vs placebo), 58% (18/31; P=.007 vs placebo), and 16% (5/31; P=.590 vs placebo), respectively. Improvements in PASI scores were observed as early as week 2. Adverse events (AEs) were reported by 65% of the risankizumab group and 88% of the placebo group. Serious AEs were reported in 4 patients receiving risankizumab, none of which were considered related to the study medication.¹

Phase 2 Trial
A phase 2 comparator trial demonstrated noninferiority at higher dosages of risankizumab in comparison to the IL-12/IL-23 inhibitor ustekinumab.² Among 166 participants with moderate to severe plaque psoriasis, PASI 90 at week 12 was met by 77% of participants receiving 90 or 180 mg of risankizumab compared to 40% receiving ustekinumab (P<.001). Onset of activity with risankizumab was faster and the duration of effect longer vs ustekinumab; by week 8, at least PASI 75 was achieved by approximately 80% of participants in the 90-mg and 180-mg risankizumab groups compared to 60% in the ustekinumab group; PASI score reductions generally were maintained for as long as 20 weeks after the final dose of risankizumab was administered.²

Phase 3 Trials
The 52-week UltIMMa-1 and UltIMMa-2 phase 3 trials compared subcutaneous risankizumab (150 mg) to ustekinumab (45 or 90 mg [weight-based dosing]) or placebo administered at weeks 0, 4, 16, 28, and 40 in approximately 1000 patients with moderate to severe plaque psoriasis.³ Patients initially assigned to placebo switched to risankizumab 150 mg at week 16. At week 16, PASI 90 was achieved by 75.3% of risankizumab-treated patients, 42.0% of ustekinumab-treated patients, and 4.9% of placebo-treated patients in UltIMMa-1, and by 74.8% of risankizumab-treated patients, 47.5% of ustekinumab-treated patients, and 2.0% of placebo-treated patients in UltIMMa-2 (P<.0001 vs placebo and ustekinumab for both studies). Achievement of a static physician’s global assessment (sPGA) score of 0 or 1 at week 16 similarly favored risankizumab, with 87.8%, 63.0%, and 7.8% of patients in UltIMMa-1 meeting an sPGA score of 0 or 1 in the risankizumab, ustekinumab, and placebo groups, respectively, and 83.7%, 61.6%, and 5.1% in UltIMMa-2 meeting an sPGA score of 0 or 1 in the risankizumab, ustekinumab, and placebo groups, respectively (P<.0001 vs placebo and ustekinumab for both studies). Among patients initially assigned to risankizumab, improvements in PASI and sPGA continued to increase until week 52, with 81.9% achieving PASI 90 at week 52 compared to 44.0% on ustekinumab in UltIMMa-1, and 80.6% achieving PASI 90 at week 52 compared to 50.5% on ustekinumab in UltIMMa-2 (P<.0001 vs ustekinumab for both studies). Treatment-emergent AE profiles were similar for risankizumab and ustekinumab in both studies, and there were no unexpected safety findings.³

Risankizumab received FDA approval for the treatment of moderate to severe plaque psoriasis in April 2019.

Bimekizumab

Bimekizumab (UCB4940), a humanized IgG1 monoclonal antibody, selectively neutralizes the biologic functions of IL-17A and IL-17F, the latter of which has only recently been implicated in contributing to the psoriatic immune cascade.⁴

First-in-Human Study
Thirty-nine participants with mild psoriasis demonstrated efficacy after single-dose intravenous bimekizumab, with maximal improvements in all measures of disease activity observed between weeks 8 and 12 in participants receiving 160 to 640 mg.⁵

Proof-of-Concept Phase 1b Study
A subsequent trial of 53 participants with psoriatic arthritis demonstrated sustained efficacy to week 20 with varying dosages of intravenous bimekizumab.⁶ At week 8, PASI 100 was met by 86.7% of participants receiving the top 3 dosages of bimekizumab compared to none of the placebo-treated participants. Treatment-emergent AEs, including neutropenia and elevation of liver transaminases, were mostly mild to moderate and resolved spontaneously. There were 3 severe AEs and 3 serious AEs, none of which were related to treatment.⁶

Importantly, bimekizumab was shown in this small study to have the potential to be highly effective at treating psoriatic arthritis. American College of Rheumatology ACR20, ACR50, and ACR70 response criteria were very high, with an ACR20 of 80% and an ACR50 of 40%.⁶ Further trials are necessary to gather more data and confirm these findings; however, these levels of response are higher than those of any other biologic on the market.

Phase 2b Dose-Ranging Study
In this trial, 250 participants with moderate to severe plaque psoriasis received either 64 mg, 160 mg with a 320-mg loading dose, 320 mg, or 480 mg of subcutaneous bimekizumab or placebo at weeks 0, 4, and 8.⁷ At week 12, PASI 90 was achieved by significantly more patients in all bimekizumab-treated groups compared to the placebo group (46.2%–79.1% vs 0%; P<.0001 for all dosages); PASI 100 also was achieved by significantly more bimekizumab-treated patients (27.9%–60.0% vs 0%; P<.0002). Improvement began as early as week 4, with clinically meaningful responses observed in all bimekizumab groups across all measures of disease activity. Treatment-emergent AEs occurred more frequently in bimekizumab-treated participants (61%) than in placebo-treated participants (36%); the most common AEs were nasopharyngitis and upper respiratory tract infection. Of note, fungal infections were reported by 4.3% of participants receiving bimekizumab; all cases were localized superficial infection, and none led to discontinuation. Three serious AEs were reported, none of which were considered related to the study treatment.⁷

Mirikizumab

Mirikizumab (LY3074828) is a humanized IgG4 monoclonal antibody that selectively binds and inhibits the p19 subunit of IL-23, with no action on IL-12.

Phase 1 Trial
Mirikizumab was shown to improve PASI scores in patients with plaque psoriasis.⁸

Phase 2 Trial
Subsequently, a trial of 205 participants with moderate to severe plaque psoriasis compared 3 dosing regimens of subcutaneous mirikizumab—30, 100, or 300 mg—at weeks 0 and 8 compared to placebo.⁹ Primary end point results at week 16 demonstrated PASI 90 response rates of 0%, 29% (P=.009), 59% (P<.001), and 67% (P<.001) in the placebo, 30-mg, 100-mg, and 300-mg mirikizumab groups, respectively. Complete clearance of psoriasis, measured by PASI 100 and sPGA 0, was achieved by 0%, 16%, 31%, and 31%, respectively (P=.039 for 30 mg vs placebo; P=.007 for the higher dosage groups vs placebo). Response rates for all efficacy outcomes were statistically significantly higher for all mirikizumab treatment groups compared to placebo and were highest in the 100-mg and 300-mg treatment groups. Frequencies of participants reporting AEs were similar across treatment and placebo groups.⁹

Oral Medications

Only a few small-molecule, orally bioavailable therapies are on the market for the treatment of psoriasis, some of which are associated with unfavorable side-effect profiles that preclude long-term therapy.

BMS-986165
The intracellular signaling enzyme tyrosine kinase 2 is involved in functional responses of IL-12 and IL-23. BMS-986165, a potent oral inhibitor of tyrosine kinase 2 with greater selectivity than other tyrosine kinase inhibitors, demonstrated efficacy in a phase 2 trial of 267 participants with moderate to severe plaque psoriasis receiving any of 5 dosing regimens—3 mg every other day, 3 mg daily, 3 mg twice daily, 6 mg twice daily, and 12 mg daily—compared to placebo.¹⁰ At week 12, the percentage of patients with a 75% or greater reduction in PASI was 7% with placebo, 9% with 3 mg every other day (P=.49 vs placebo), 39% with 3 mg daily (P<.001 vs placebo), 69% with 3 mg twice daily (P<.001 vs placebo), 67% with 6 mg twice daily (P<.001 vs placebo), and 75% with 12 mg once daily (P<.001 vs placebo). Adverse events occurred in 51% of patients in the placebo group and in 55% to 80% of BMS-986165–treated patients; the most common AEs were nasopharyngitis, headache, diarrhea, nausea, and upper respiratory tract infection.¹⁰

A phase 3 trial comparing BMS-986165 with placebo and apremilast is underway (ClinicalTrials.gov Identifier NCT03611751).

Piclidenoson (CF101)
A novel small molecule that binds the Gi protein–associated A₃ adenosine receptor piclidenoson induces an anti-inflammatory response via deregulation of the Wnt and nuclear factor κB signal transduction pathways, leading to downregulation of proinflammatory cytokines, including IL-17 and IL-23.¹¹

In a phase 2 dose-ranging study, 75 patients with moderate to severe plaque psoriasis received varying dosages—1, 2, or 4 mg—of oral piclidenoson or placebo twice daily for 12 weeks.¹² Progressive improvement in the mean change from baseline PASI score was observed in the 2-mg group, with statistically significant differences at weeks 8 and 12 compared to placebo (P=.047 and P=.031, respectively). At week 12, 35.3% of the 2-mg group achieved at least PASI 50. Improvements in PASI were less pronounced in the 4-mg group, and no therapeutic benefit was observed in the 1-mg group. Of the 20 AEs reported, 15 possibly were related to the study drug; 1 AE was severe.¹²

In a subsequent phase 2/3 trial, patients with moderate to severe plaque psoriasis received piclidenoson—1 or 2 mg—or placebo twice daily.¹³ At week 12, PASI 75 was achieved by 8.5% of patients in the 2-mg group and by 6.9% of patients receiving placebo (P=.621), thereby not meeting the primary study end point. Results at week 32 were more encouraging. In the 2-mg group, PASI mean percentage improvement was 57% (P<.002) compared to baseline, with linear improvements observed in PASI 50 (63.5%), PASI 75 (35.5%), PASI 90 (24.7%), and PASI 100 (10.6%).¹³

A phase 3 trial comparing piclidenoson 2 and 3 mg to apremilast and placebo is in progress (ClinicalTrials.gov Identifier NCT03168256).

Future Directions

Despite abundant options for treating moderate to severe plaque psoriasis and psoriatic arthritis, the pipeline remains rich. Novel treatments might have improved efficacy, favorable safety profiles, and different modes of administration compared to current medications. In addition to the novel therapeutics covered here, several treatments are in development further down the pipeline, with only phase 1 or 2 data available. Remtolumab (ABT-122), a tumor necrosis factor α– and IL-17A–targeted immunoglobulin, is unique among biologics, given its dual inhibition of tumor necrosis factor α and IL-17A.¹⁴ M1095 (ALX-0761), a novel trivalent bispecific nanobody, is another intriguing candidate. This dual inhibitor of IL-17A/F might exhibit a number of advantages over conventional antibodies, including better tissue penetration, reduced immunogenicity, and a longer half-life (ClinicalTrials.gov Identifier NCT03384745).^15,16

As always with drug development, numerous medications that were under development failed to meet primary end points in phase 2 trials and have therefore been discontinued, including namilumab and prurisol. It is reassuring that the pace of drug discovery and development in psoriasis does not seem to be slowing; to our patients’ benefit, we will have an array of treatments available to tailor therapy to the individual.

Recent advances in our understanding of psoriatic immune pathways have led to new generations of targeted therapies developed over the last 5 years. Although the pathogenesis of psoriasis remains to be fully elucidated, the success of these targeted therapies has confirmed a critical role of the IL-23/helper T cell (T_H17) axis in maintaining the psoriatic immune cascade, a positive feedback loop in which IL-17, IL-12, and IL-23 released from myeloid dendritic cells lead to activation of helperT cells. Activated helper T cells—namely T_H1, T_H17, and T_H22—release IL-17, IL-22, and other proinflammatory cytokines, amplifying the immune response and leading to keratinocyte proliferation and immune cell migration to psoriatic lesions. Inhibition of IL-17 and IL-23 by several biologics disrupts this aberrant inflammatory cascade and has led to dramatic improvements in outcomes, particularly among patients with moderate to severe disease.

Numerous biologics targeting these pathways and several oral treatments have been approved by the US Food and Drug Administration (FDA) for the treatment of psoriasis; in addition, a number of promising therapies are on the horizon, and knowledge of these medications might help guide our treatment approach to the patient with psoriasis. This article provides an update on the most recent (as of 2019) approved therapies and medications in the pipeline for moderate to severe plaque psoriasis, with a focus on systemic agents in phase 3 clinical trials. (Medications targeting psoriatic arthritis, biosimilars, and existing medications approved by the FDA prior to 2019 will not be discussed.)

Risankizumab

Risankizumab-rzaa (formerly BI 655066) is a humanized IgG1 monoclonal antibody that targets the p19 subunit of IL-23, selectively inhibiting the role of this critical cytokine in psoriatic inflammation.

Phase 1 Trial
In a phase 1 proof-of-concept study, 39 patients with moderate to severe plaque psoriasis received varying dosages of intravenous or subcutaneous risankizumab or placebo.¹ At week 12, the percentage of risankizumab-treated patients achieving reduction in the psoriasis area and severity index (PASI) score by 75% (PASI 75), 90% (PASI 90), and 100% (PASI 100) was 87% (27/31; P<.001 vs placebo), 58% (18/31; P=.007 vs placebo), and 16% (5/31; P=.590 vs placebo), respectively. Improvements in PASI scores were observed as early as week 2. Adverse events (AEs) were reported by 65% of the risankizumab group and 88% of the placebo group. Serious AEs were reported in 4 patients receiving risankizumab, none of which were considered related to the study medication.¹

Phase 2 Trial
A phase 2 comparator trial demonstrated noninferiority at higher dosages of risankizumab in comparison to the IL-12/IL-23 inhibitor ustekinumab.² Among 166 participants with moderate to severe plaque psoriasis, PASI 90 at week 12 was met by 77% of participants receiving 90 or 180 mg of risankizumab compared to 40% receiving ustekinumab (P<.001). Onset of activity with risankizumab was faster and the duration of effect longer vs ustekinumab; by week 8, at least PASI 75 was achieved by approximately 80% of participants in the 90-mg and 180-mg risankizumab groups compared to 60% in the ustekinumab group; PASI score reductions generally were maintained for as long as 20 weeks after the final dose of risankizumab was administered.²

Phase 3 Trials
The 52-week UltIMMa-1 and UltIMMa-2 phase 3 trials compared subcutaneous risankizumab (150 mg) to ustekinumab (45 or 90 mg [weight-based dosing]) or placebo administered at weeks 0, 4, 16, 28, and 40 in approximately 1000 patients with moderate to severe plaque psoriasis.³ Patients initially assigned to placebo switched to risankizumab 150 mg at week 16. At week 16, PASI 90 was achieved by 75.3% of risankizumab-treated patients, 42.0% of ustekinumab-treated patients, and 4.9% of placebo-treated patients in UltIMMa-1, and by 74.8% of risankizumab-treated patients, 47.5% of ustekinumab-treated patients, and 2.0% of placebo-treated patients in UltIMMa-2 (P<.0001 vs placebo and ustekinumab for both studies). Achievement of a static physician’s global assessment (sPGA) score of 0 or 1 at week 16 similarly favored risankizumab, with 87.8%, 63.0%, and 7.8% of patients in UltIMMa-1 meeting an sPGA score of 0 or 1 in the risankizumab, ustekinumab, and placebo groups, respectively, and 83.7%, 61.6%, and 5.1% in UltIMMa-2 meeting an sPGA score of 0 or 1 in the risankizumab, ustekinumab, and placebo groups, respectively (P<.0001 vs placebo and ustekinumab for both studies). Among patients initially assigned to risankizumab, improvements in PASI and sPGA continued to increase until week 52, with 81.9% achieving PASI 90 at week 52 compared to 44.0% on ustekinumab in UltIMMa-1, and 80.6% achieving PASI 90 at week 52 compared to 50.5% on ustekinumab in UltIMMa-2 (P<.0001 vs ustekinumab for both studies). Treatment-emergent AE profiles were similar for risankizumab and ustekinumab in both studies, and there were no unexpected safety findings.³

Risankizumab received FDA approval for the treatment of moderate to severe plaque psoriasis in April 2019.

Bimekizumab

Bimekizumab (UCB4940), a humanized IgG1 monoclonal antibody, selectively neutralizes the biologic functions of IL-17A and IL-17F, the latter of which has only recently been implicated in contributing to the psoriatic immune cascade.⁴

First-in-Human Study
Thirty-nine participants with mild psoriasis demonstrated efficacy after single-dose intravenous bimekizumab, with maximal improvements in all measures of disease activity observed between weeks 8 and 12 in participants receiving 160 to 640 mg.⁵

Proof-of-Concept Phase 1b Study
A subsequent trial of 53 participants with psoriatic arthritis demonstrated sustained efficacy to week 20 with varying dosages of intravenous bimekizumab.⁶ At week 8, PASI 100 was met by 86.7% of participants receiving the top 3 dosages of bimekizumab compared to none of the placebo-treated participants. Treatment-emergent AEs, including neutropenia and elevation of liver transaminases, were mostly mild to moderate and resolved spontaneously. There were 3 severe AEs and 3 serious AEs, none of which were related to treatment.⁶

Importantly, bimekizumab was shown in this small study to have the potential to be highly effective at treating psoriatic arthritis. American College of Rheumatology ACR20, ACR50, and ACR70 response criteria were very high, with an ACR20 of 80% and an ACR50 of 40%.⁶ Further trials are necessary to gather more data and confirm these findings; however, these levels of response are higher than those of any other biologic on the market.

Phase 2b Dose-Ranging Study
In this trial, 250 participants with moderate to severe plaque psoriasis received either 64 mg, 160 mg with a 320-mg loading dose, 320 mg, or 480 mg of subcutaneous bimekizumab or placebo at weeks 0, 4, and 8.⁷ At week 12, PASI 90 was achieved by significantly more patients in all bimekizumab-treated groups compared to the placebo group (46.2%–79.1% vs 0%; P<.0001 for all dosages); PASI 100 also was achieved by significantly more bimekizumab-treated patients (27.9%–60.0% vs 0%; P<.0002). Improvement began as early as week 4, with clinically meaningful responses observed in all bimekizumab groups across all measures of disease activity. Treatment-emergent AEs occurred more frequently in bimekizumab-treated participants (61%) than in placebo-treated participants (36%); the most common AEs were nasopharyngitis and upper respiratory tract infection. Of note, fungal infections were reported by 4.3% of participants receiving bimekizumab; all cases were localized superficial infection, and none led to discontinuation. Three serious AEs were reported, none of which were considered related to the study treatment.⁷

Mirikizumab

Mirikizumab (LY3074828) is a humanized IgG4 monoclonal antibody that selectively binds and inhibits the p19 subunit of IL-23, with no action on IL-12.

Phase 1 Trial
Mirikizumab was shown to improve PASI scores in patients with plaque psoriasis.⁸

Phase 2 Trial
Subsequently, a trial of 205 participants with moderate to severe plaque psoriasis compared 3 dosing regimens of subcutaneous mirikizumab—30, 100, or 300 mg—at weeks 0 and 8 compared to placebo.⁹ Primary end point results at week 16 demonstrated PASI 90 response rates of 0%, 29% (P=.009), 59% (P<.001), and 67% (P<.001) in the placebo, 30-mg, 100-mg, and 300-mg mirikizumab groups, respectively. Complete clearance of psoriasis, measured by PASI 100 and sPGA 0, was achieved by 0%, 16%, 31%, and 31%, respectively (P=.039 for 30 mg vs placebo; P=.007 for the higher dosage groups vs placebo). Response rates for all efficacy outcomes were statistically significantly higher for all mirikizumab treatment groups compared to placebo and were highest in the 100-mg and 300-mg treatment groups. Frequencies of participants reporting AEs were similar across treatment and placebo groups.⁹

Oral Medications

Only a few small-molecule, orally bioavailable therapies are on the market for the treatment of psoriasis, some of which are associated with unfavorable side-effect profiles that preclude long-term therapy.

BMS-986165
The intracellular signaling enzyme tyrosine kinase 2 is involved in functional responses of IL-12 and IL-23. BMS-986165, a potent oral inhibitor of tyrosine kinase 2 with greater selectivity than other tyrosine kinase inhibitors, demonstrated efficacy in a phase 2 trial of 267 participants with moderate to severe plaque psoriasis receiving any of 5 dosing regimens—3 mg every other day, 3 mg daily, 3 mg twice daily, 6 mg twice daily, and 12 mg daily—compared to placebo.¹⁰ At week 12, the percentage of patients with a 75% or greater reduction in PASI was 7% with placebo, 9% with 3 mg every other day (P=.49 vs placebo), 39% with 3 mg daily (P<.001 vs placebo), 69% with 3 mg twice daily (P<.001 vs placebo), 67% with 6 mg twice daily (P<.001 vs placebo), and 75% with 12 mg once daily (P<.001 vs placebo). Adverse events occurred in 51% of patients in the placebo group and in 55% to 80% of BMS-986165–treated patients; the most common AEs were nasopharyngitis, headache, diarrhea, nausea, and upper respiratory tract infection.¹⁰

A phase 3 trial comparing BMS-986165 with placebo and apremilast is underway (ClinicalTrials.gov Identifier NCT03611751).

Piclidenoson (CF101)
A novel small molecule that binds the Gi protein–associated A₃ adenosine receptor piclidenoson induces an anti-inflammatory response via deregulation of the Wnt and nuclear factor κB signal transduction pathways, leading to downregulation of proinflammatory cytokines, including IL-17 and IL-23.¹¹

In a phase 2 dose-ranging study, 75 patients with moderate to severe plaque psoriasis received varying dosages—1, 2, or 4 mg—of oral piclidenoson or placebo twice daily for 12 weeks.¹² Progressive improvement in the mean change from baseline PASI score was observed in the 2-mg group, with statistically significant differences at weeks 8 and 12 compared to placebo (P=.047 and P=.031, respectively). At week 12, 35.3% of the 2-mg group achieved at least PASI 50. Improvements in PASI were less pronounced in the 4-mg group, and no therapeutic benefit was observed in the 1-mg group. Of the 20 AEs reported, 15 possibly were related to the study drug; 1 AE was severe.¹²

In a subsequent phase 2/3 trial, patients with moderate to severe plaque psoriasis received piclidenoson—1 or 2 mg—or placebo twice daily.¹³ At week 12, PASI 75 was achieved by 8.5% of patients in the 2-mg group and by 6.9% of patients receiving placebo (P=.621), thereby not meeting the primary study end point. Results at week 32 were more encouraging. In the 2-mg group, PASI mean percentage improvement was 57% (P<.002) compared to baseline, with linear improvements observed in PASI 50 (63.5%), PASI 75 (35.5%), PASI 90 (24.7%), and PASI 100 (10.6%).¹³

A phase 3 trial comparing piclidenoson 2 and 3 mg to apremilast and placebo is in progress (ClinicalTrials.gov Identifier NCT03168256).

Future Directions

Despite abundant options for treating moderate to severe plaque psoriasis and psoriatic arthritis, the pipeline remains rich. Novel treatments might have improved efficacy, favorable safety profiles, and different modes of administration compared to current medications. In addition to the novel therapeutics covered here, several treatments are in development further down the pipeline, with only phase 1 or 2 data available. Remtolumab (ABT-122), a tumor necrosis factor α– and IL-17A–targeted immunoglobulin, is unique among biologics, given its dual inhibition of tumor necrosis factor α and IL-17A.¹⁴ M1095 (ALX-0761), a novel trivalent bispecific nanobody, is another intriguing candidate. This dual inhibitor of IL-17A/F might exhibit a number of advantages over conventional antibodies, including better tissue penetration, reduced immunogenicity, and a longer half-life (ClinicalTrials.gov Identifier NCT03384745).^15,16

As always with drug development, numerous medications that were under development failed to meet primary end points in phase 2 trials and have therefore been discontinued, including namilumab and prurisol. It is reassuring that the pace of drug discovery and development in psoriasis does not seem to be slowing; to our patients’ benefit, we will have an array of treatments available to tailor therapy to the individual.

As psychiatry mourns Carl Compton Bell, MD, a giant in our field, we pay homage to his legacy of leadership and productivity.

Dr. Bell wore many hats: community psychiatrist par excellence, award-winning researcher, clinician, public health advocate, mentor, and activist. Eschewing the mold of the stereotypical psychiatrist, he lectured in cowboy hats, baseball caps, message T-shirts, and shades – all conveying his youthful, down-to-earth, yet serious, psychiatrist-of-the-people style. He demonstrated that scholarship could combat racial inequities and made it clear that he had much to accomplish yet little to prove.

Dr. Bell implored physicians to not only treat health problems but also to rectify “upstream” issues. He encouraged their engagement in “bent-nail research,” empirical study directly in the communities where they work – even with limited resources. This approach, rooted in public health and prevention, undergirds his groundbreaking work in the treatment of fetal alcohol exposure with choline and folic acid. HIV prevention in South Africa was another area of study where he developed innovative strategies with successful outcomes. In his study of trauma in youth, he underscored that “risk factors are not predictive factors because of protective factors.”

He promoted social fabric, an adult protective shield, connectedness, self-esteem, self-efficacy, and social skills as protective. He understood that, with treatment and community supports, children exposed to violence were not doomed to a life of aberrant behavior.

A prolific author, Dr. Bell’s peer-reviewed articles are often cited and have become the gospel for community mental health. He bemoaned the insufficient translation of published research into reality in the community. His writings suggested that psychiatry should not assume that its standards of diagnosis and treatment apply entirely to nonwhite populations. This fact remains a call to action for those of us he leaves behind.

As a clinician, Dr. Bell listened intently to his patients to understand their current situations, histories, family histories, and contexts in which they lived. He was so dedicated to their care that, when a mental health center he led for years abruptly closed its doors, he set up a makeshift office on the front sidewalk to serve patients who might not have known about its closure.

Dr. Bell was active in organized psychiatry, serving as past chair of the American Psychiatric Association Council on Social Issues and Public Psychiatry. He inspired the creation of the APA’s Transformational Leadership in Public Psychiatry Fellowship for early- and mid-career psychiatrists. A loyal member of the Black Psychiatrists of America, he took pride in having saved all of BPA’s newsletters dating back to its founding in 1969.

His participation in those associations and in the National Medical Association was an avenue through which his robust scholarship encouraged the next generations of black psychiatrists. Those countless psychiatrists who trusted Dr. Bell’s wise counsel have gone on to become leaders. They are proof that his extraordinary accomplishments and spirit will live on through the multiplier effect of their contributions to the field and mentorship of future psychiatrists for years to come.
 

Dr. Gordon-Achebe is a child, adolescent, and adult psychiatrist practicing in the Baltimore metropolitan area. She is the immediate past president of the American Psychiatric Association’s Caucus of Black Psychiatrists and vice chair for the Council on Children, Adolescents and Their Families.

Dr. Hairston is the psychiatry residency training director at Howard University in Washington. She is the newly elected president of the American Psychiatric Association’s Caucus of Black Psychiatrists and the scientific program committee chair for the Black Psychiatrists of America.

Dr. Starks is a geriatric psychiatrist and Health and Aging Policy Fellow currently working on Capitol Hill in Washington. He is the representative to the assembly for the APA Caucus of Black Psychiatrists. He has nurtured a keen interest in understanding the cultural and social effects of geriatric mental health conditions on the lives of patients and families.

Dr. Primm, a community psychiatrist based in Baltimore, is senior medical director of the Steve Fund, which is focused on the mental health and emotional well-being of young people of color, including college students. She formerly served as deputy medical director of the APA and director of APA’s division of diversity and health equity, previously known as the Office of Minority and National Affairs.

As psychiatry mourns Carl Compton Bell, MD, a giant in our field, we pay homage to his legacy of leadership and productivity.

Dr. Bell wore many hats: community psychiatrist par excellence, award-winning researcher, clinician, public health advocate, mentor, and activist. Eschewing the mold of the stereotypical psychiatrist, he lectured in cowboy hats, baseball caps, message T-shirts, and shades – all conveying his youthful, down-to-earth, yet serious, psychiatrist-of-the-people style. He demonstrated that scholarship could combat racial inequities and made it clear that he had much to accomplish yet little to prove.

Dr. Bell implored physicians to not only treat health problems but also to rectify “upstream” issues. He encouraged their engagement in “bent-nail research,” empirical study directly in the communities where they work – even with limited resources. This approach, rooted in public health and prevention, undergirds his groundbreaking work in the treatment of fetal alcohol exposure with choline and folic acid. HIV prevention in South Africa was another area of study where he developed innovative strategies with successful outcomes. In his study of trauma in youth, he underscored that “risk factors are not predictive factors because of protective factors.”

He promoted social fabric, an adult protective shield, connectedness, self-esteem, self-efficacy, and social skills as protective. He understood that, with treatment and community supports, children exposed to violence were not doomed to a life of aberrant behavior.

A prolific author, Dr. Bell’s peer-reviewed articles are often cited and have become the gospel for community mental health. He bemoaned the insufficient translation of published research into reality in the community. His writings suggested that psychiatry should not assume that its standards of diagnosis and treatment apply entirely to nonwhite populations. This fact remains a call to action for those of us he leaves behind.

As a clinician, Dr. Bell listened intently to his patients to understand their current situations, histories, family histories, and contexts in which they lived. He was so dedicated to their care that, when a mental health center he led for years abruptly closed its doors, he set up a makeshift office on the front sidewalk to serve patients who might not have known about its closure.

Dr. Bell was active in organized psychiatry, serving as past chair of the American Psychiatric Association Council on Social Issues and Public Psychiatry. He inspired the creation of the APA’s Transformational Leadership in Public Psychiatry Fellowship for early- and mid-career psychiatrists. A loyal member of the Black Psychiatrists of America, he took pride in having saved all of BPA’s newsletters dating back to its founding in 1969.

His participation in those associations and in the National Medical Association was an avenue through which his robust scholarship encouraged the next generations of black psychiatrists. Those countless psychiatrists who trusted Dr. Bell’s wise counsel have gone on to become leaders. They are proof that his extraordinary accomplishments and spirit will live on through the multiplier effect of their contributions to the field and mentorship of future psychiatrists for years to come.
 

Dr. Gordon-Achebe is a child, adolescent, and adult psychiatrist practicing in the Baltimore metropolitan area. She is the immediate past president of the American Psychiatric Association’s Caucus of Black Psychiatrists and vice chair for the Council on Children, Adolescents and Their Families.

Dr. Hairston is the psychiatry residency training director at Howard University in Washington. She is the newly elected president of the American Psychiatric Association’s Caucus of Black Psychiatrists and the scientific program committee chair for the Black Psychiatrists of America.

Dr. Starks is a geriatric psychiatrist and Health and Aging Policy Fellow currently working on Capitol Hill in Washington. He is the representative to the assembly for the APA Caucus of Black Psychiatrists. He has nurtured a keen interest in understanding the cultural and social effects of geriatric mental health conditions on the lives of patients and families.

Dr. Primm, a community psychiatrist based in Baltimore, is senior medical director of the Steve Fund, which is focused on the mental health and emotional well-being of young people of color, including college students. She formerly served as deputy medical director of the APA and director of APA’s division of diversity and health equity, previously known as the Office of Minority and National Affairs.

As psychiatry mourns Carl Compton Bell, MD, a giant in our field, we pay homage to his legacy of leadership and productivity.

Dr. Bell wore many hats: community psychiatrist par excellence, award-winning researcher, clinician, public health advocate, mentor, and activist. Eschewing the mold of the stereotypical psychiatrist, he lectured in cowboy hats, baseball caps, message T-shirts, and shades – all conveying his youthful, down-to-earth, yet serious, psychiatrist-of-the-people style. He demonstrated that scholarship could combat racial inequities and made it clear that he had much to accomplish yet little to prove.

Dr. Bell implored physicians to not only treat health problems but also to rectify “upstream” issues. He encouraged their engagement in “bent-nail research,” empirical study directly in the communities where they work – even with limited resources. This approach, rooted in public health and prevention, undergirds his groundbreaking work in the treatment of fetal alcohol exposure with choline and folic acid. HIV prevention in South Africa was another area of study where he developed innovative strategies with successful outcomes. In his study of trauma in youth, he underscored that “risk factors are not predictive factors because of protective factors.”

He promoted social fabric, an adult protective shield, connectedness, self-esteem, self-efficacy, and social skills as protective. He understood that, with treatment and community supports, children exposed to violence were not doomed to a life of aberrant behavior.

A prolific author, Dr. Bell’s peer-reviewed articles are often cited and have become the gospel for community mental health. He bemoaned the insufficient translation of published research into reality in the community. His writings suggested that psychiatry should not assume that its standards of diagnosis and treatment apply entirely to nonwhite populations. This fact remains a call to action for those of us he leaves behind.

As a clinician, Dr. Bell listened intently to his patients to understand their current situations, histories, family histories, and contexts in which they lived. He was so dedicated to their care that, when a mental health center he led for years abruptly closed its doors, he set up a makeshift office on the front sidewalk to serve patients who might not have known about its closure.

Dr. Bell was active in organized psychiatry, serving as past chair of the American Psychiatric Association Council on Social Issues and Public Psychiatry. He inspired the creation of the APA’s Transformational Leadership in Public Psychiatry Fellowship for early- and mid-career psychiatrists. A loyal member of the Black Psychiatrists of America, he took pride in having saved all of BPA’s newsletters dating back to its founding in 1969.

His participation in those associations and in the National Medical Association was an avenue through which his robust scholarship encouraged the next generations of black psychiatrists. Those countless psychiatrists who trusted Dr. Bell’s wise counsel have gone on to become leaders. They are proof that his extraordinary accomplishments and spirit will live on through the multiplier effect of their contributions to the field and mentorship of future psychiatrists for years to come.
 

Dr. Gordon-Achebe is a child, adolescent, and adult psychiatrist practicing in the Baltimore metropolitan area. She is the immediate past president of the American Psychiatric Association’s Caucus of Black Psychiatrists and vice chair for the Council on Children, Adolescents and Their Families.

Dr. Hairston is the psychiatry residency training director at Howard University in Washington. She is the newly elected president of the American Psychiatric Association’s Caucus of Black Psychiatrists and the scientific program committee chair for the Black Psychiatrists of America.

Dr. Starks is a geriatric psychiatrist and Health and Aging Policy Fellow currently working on Capitol Hill in Washington. He is the representative to the assembly for the APA Caucus of Black Psychiatrists. He has nurtured a keen interest in understanding the cultural and social effects of geriatric mental health conditions on the lives of patients and families.

Dr. Primm, a community psychiatrist based in Baltimore, is senior medical director of the Steve Fund, which is focused on the mental health and emotional well-being of young people of color, including college students. She formerly served as deputy medical director of the APA and director of APA’s division of diversity and health equity, previously known as the Office of Minority and National Affairs.

With the heart of a child and the spirit of a warrior, Carl Bell always spoke his truth. And, he did so in his own inimitable way. Sporting his signature dark brown wide-brim leather cowboy hat or NMA (National Medical Association) baseball cap, aviator sunglasses, and accompanying Superman belt buckle, Carl Compton Bell, MD, – psychiatrist, researcher, mental health advocate, father, grandfather, friend, colleague, pioneer, and servant – was driven by a deep commitment to serve others.

As those who truly knew him can attest, it is not hyperbole to say that Carl Compton Bell was one of the most genuine, brilliant, and humble physicians of our professional community and time.

My collaboration and friendship began with Dr. Bell began during the summer of 2016 as I was preparing for the 2017 Washington Psychiatric Society’s (WPS) Presidential Symposium at Saint Elizabeths Hospital. As president of WPS, I had chosen gun violence as my topic and sought out Dr. Bell because of his work on the South Side of Chicago, where he had devoted himself, becoming an internationally known clinician, researcher, and mental health advocate for those personally affected by violence and trauma. He immediately accepted.

In his presentation, “Gun Violence, Urban Youth and Mental Illness,” he reviewed his research on the neurocognitive behavioral effects of prenatal exposure to alcohol and its relation to the neurodevelopmental dynamics of youth violence, intimate partner violence, and mass shootings. Dr. Bell suggested that the relationship between prenatal exposure to alcohol and the diagnosis of numerous psychiatric conditions had been underestimated in the medical community. He eventually summarized his work in Fetal Alcohol Exposure in the African-American Community, published by Third World Press (2018). This vital resource not only summarizes in plain language the scope of the problem of prenatal alcohol exposure but is a narrative of Carl Bell’s life journey.

After the symposium, he would send articles, while warning, “I can bombard you with stuff.” Sometimes we would not speak for weeks at a time while I digested the resources he had shared. However, whenever I picked up the phone to call and respond to what he had provided, he would answer the phone, “Yessssss?” – as if he were anticipating my call and was ready to address any queries or comments I might have. Even when he were about to board a plane or charting – after making rounds on his patients while listening to the music of James Brown – he would answer the phone, even if only to coordinate a more mutually convenient time to connect.

During the process of digesting the plethora of articles and resources he provided on prenatal fetal alcohol exposure, including the 1996 Institute of Medicine’s report and the American Medical Association’s 2017 resolution supporting the addition of adequate amounts of choline to prenatal vitamins, I found myself immersed in neuroscience topics, such as the role of neuronal acetylcholine receptor subunit alpha-7 in the formation of neurotransmitters, the strengthening of cell membranes, and the promotion of proper brain and spinal cord development. Dr. Bell spoke authoritatively about the neuroscience and the public health implications. One of his mantras was “Where is the data? You’ve got to have data.”

Courtesy Dr. Constance E. Dunlap

The information that he shared became the foundation of the action paper calling for the American Psychiatric Association (APA) to endorse the AMA’s resolution supporting the addition of adequate amounts (450 mg/d for pregnant women) of phosphatidylcholine to prenatal vitamins. The APA Assembly passed this action paper in May 2018.

He was also responsible for a second action paper, “Psychiatric Management of the Impact of Racism on Social and Clinical Events,” which passed at the same May 2018 assembly. Dr. Bell agreed to coauthor this paper, which was only fitting since the paper was a further elaboration of his efforts with the APA Caucus of Black Psychiatrists to implore the APA to acknowledge the deleterious effects of racism on both the victim and perpetrator.

While researching this topic, I had come across his 1980 article, Racism: A Symptom of the Narcissistic Personality Disorder (J Nat Med Assoc. 1980 Jul;72[7]:661-5), in which Dr. Bell applied psychoanalytic theory to posit that racism is one psychic derivative through which narcissism may manifest itself.

Although he was not formally trained as a psychoanalyst, he had benefited from strong psychoanalytic supervision at the Illinois State Psychiatric Institute, a training program of the University of Illinois at Chicago. He wrote confidently and clearly, applying self-psychology principles. He had the gravitas to write and speak about a range of topics, from neuroscience, psychotherapy, medical management of illness, and mental health advocacy. His 387-page curriculum vitae of 500+ articles, chapters, and books on mental health issues is a catalog of evidence that he had given thought to just about any topic along the spectrum of psychiatry and beyond.

In July 2018, after leaving a performance of “Hamilton” at the Kennedy Center, a lyric from the song “Non-Stop” stayed with me:

Why do you write like you’re running out of time?

(Why do you write like you’re running out of time?)

Write day and night like you’re running out of time?

The pace at which he read, wrote, lectured, researched, collaborated, and served on committees reminded me of the prodigious work of the former Secretary of the Treasury. When I shared this with Dr. Bell, he volunteered that he wrote to clear his mind. I suggested that, like other true writers, it seemed that he had to write. He did not disagree.

Courtesy Dr. Constance E. Dunlap

Dr. Bell and his peers applied their education and training to improve clinical care for all, to decrease health inequities, and to eliminate disparities. It is evident that he loved his people and committed his life to addressing the needs of marginalized communities, those without the benefit of abundant resources, and those disproportionately affected by violence and trauma. As he stated in his last book, Fetal Alcohol Exposure in the African-American Community:

“I should add, my main concern is African American people living within the United States of America where in one community the rate of Fetal Alcohol Exposure is 388/1,000 people. ... However, this problem extends much further. Fetal Alcohol Exposure (FAE) is increasingly being found to (be) problematic in people of color around the world: Native Americans in Canada ... Aboriginal people in Australia ... and various tribes of people on the continent of Africa. ... Lastly, while the problem of Fetal Alcohol Exposure seems to be disproportionately affecting people of color, it also affects people who lack pigment in their skin. For example, FAE is a problem in Russia. From a public health perspective, so often people of color are like the proverbial “canary in a coal mine,” i.e., if there is poisonous gas in the coal mine, the canary will die first, warning the miners that they need to do something about it.”

Courtesy Dr. Constance E. Dunlap

However, it would be a profound mistake to conclude that his work was restricted to black and brown communities. Dr. Bell was a Distinguished Lifetime Fellow of the American Psychiatric Association and a Lifetime Fellow of the American College of Psychiatrists. He was a founding member of the board of directors of the National Commission on Correctional Health, and a member of prominent work groups of the National Institutes of Mental Health and the National Academy of Medicine (formerly the Institute of Medicine). And Dr. Bell’s mentees and students transcend generations, race, religions, professional disciplines, and national boundaries.

Because Dr. Bell was grounded and never forgot his roots, it was in these professional society circles that he ensured that clinicians with more privilege and limited or no exposure to communities of color were educated about the needs of those he treated. Without exposure to Carl Bell, it is likely that many of our psychiatric colleagues would remain unaware of both the brilliant dynamic resources and enormous challenges that are found in the black community and communities of color. By sharing his work with the house of medicine, he obviated the excuse of doing nothing because of ignorance.

Courtesy Dr. Constance E. Dunlap

I last saw Dr. Bell in San Francisco toward the end of the 2019 annual APA meeting. He had received the APA’s Adolf* Meyer Award for lifetime achievement. Afterward, I joined him for a dim sum lunch in Chinatown with two of his colleagues and Joseph Calhoun, his mentee in the APA’s Black Men in Psychiatry Early Pipeline Program. As we walked back to our respective hotels, we paused at what is now the Chinese Affirmative Action Center. We learned that this site had been the home of one of Dr. Bell’s former martial arts instructors. As Dr. Bell recounted his martial arts training, the reverence for his sensei was evident in his eyes.

When I reflect on how much I learned from and about Carl Bell in such a short period of time, I realize that he was one of those people who was so present and so astute that he allowed you to know him while he was giving.

So, how do we honor someone who gave so much of himself? When I now think of the lyric from “Hamilton” – “Why do you write like you’re running out of time?” – I realize that we get it twisted when we associate running out of time with our elders and their phase of life. It was not Carl Bell who was running out of time. He had been extraordinarily respectful of the space, time, and energy allotted to him in his lifetime. He would say, “People squander their personal resources.” He certainly had not squandered his.

As we reflect and mourn his passing, we will hear about his candor, authenticity, integrity, discipline, reliability, dedication, and serving spirit. This is called character.

Dr. Bell was beyond generous with his life, and it is going to take decades, if not more, for us to digest the compendium of knowledge that he left behind. I ask you: How will you use that knowledge to advance the causes he so diligently devoted his life to solving?

To Carl Compton Bell, I say, Well done. Thank you. And, rest now my dear brother.
 

Dr. Dunlap, a psychiatrist and psychoanalyst who practices in Washington, is a Washington Psychiatric Society representative to the APA Assembly, a past president of the Washington Psychiatric Society, and clinical professor of psychiatry and behavioral sciences at George Washington University, Washington. She is interested in the role “difference” – race, culture, and ethnicity – plays in interpersonal relationships and group dynamics.

*This column was updated 9/3/2019.

With the heart of a child and the spirit of a warrior, Carl Bell always spoke his truth. And, he did so in his own inimitable way. Sporting his signature dark brown wide-brim leather cowboy hat or NMA (National Medical Association) baseball cap, aviator sunglasses, and accompanying Superman belt buckle, Carl Compton Bell, MD, – psychiatrist, researcher, mental health advocate, father, grandfather, friend, colleague, pioneer, and servant – was driven by a deep commitment to serve others.

As those who truly knew him can attest, it is not hyperbole to say that Carl Compton Bell was one of the most genuine, brilliant, and humble physicians of our professional community and time.

My collaboration and friendship began with Dr. Bell began during the summer of 2016 as I was preparing for the 2017 Washington Psychiatric Society’s (WPS) Presidential Symposium at Saint Elizabeths Hospital. As president of WPS, I had chosen gun violence as my topic and sought out Dr. Bell because of his work on the South Side of Chicago, where he had devoted himself, becoming an internationally known clinician, researcher, and mental health advocate for those personally affected by violence and trauma. He immediately accepted.

In his presentation, “Gun Violence, Urban Youth and Mental Illness,” he reviewed his research on the neurocognitive behavioral effects of prenatal exposure to alcohol and its relation to the neurodevelopmental dynamics of youth violence, intimate partner violence, and mass shootings. Dr. Bell suggested that the relationship between prenatal exposure to alcohol and the diagnosis of numerous psychiatric conditions had been underestimated in the medical community. He eventually summarized his work in Fetal Alcohol Exposure in the African-American Community, published by Third World Press (2018). This vital resource not only summarizes in plain language the scope of the problem of prenatal alcohol exposure but is a narrative of Carl Bell’s life journey.

After the symposium, he would send articles, while warning, “I can bombard you with stuff.” Sometimes we would not speak for weeks at a time while I digested the resources he had shared. However, whenever I picked up the phone to call and respond to what he had provided, he would answer the phone, “Yessssss?” – as if he were anticipating my call and was ready to address any queries or comments I might have. Even when he were about to board a plane or charting – after making rounds on his patients while listening to the music of James Brown – he would answer the phone, even if only to coordinate a more mutually convenient time to connect.

During the process of digesting the plethora of articles and resources he provided on prenatal fetal alcohol exposure, including the 1996 Institute of Medicine’s report and the American Medical Association’s 2017 resolution supporting the addition of adequate amounts of choline to prenatal vitamins, I found myself immersed in neuroscience topics, such as the role of neuronal acetylcholine receptor subunit alpha-7 in the formation of neurotransmitters, the strengthening of cell membranes, and the promotion of proper brain and spinal cord development. Dr. Bell spoke authoritatively about the neuroscience and the public health implications. One of his mantras was “Where is the data? You’ve got to have data.”

Courtesy Dr. Constance E. Dunlap

The information that he shared became the foundation of the action paper calling for the American Psychiatric Association (APA) to endorse the AMA’s resolution supporting the addition of adequate amounts (450 mg/d for pregnant women) of phosphatidylcholine to prenatal vitamins. The APA Assembly passed this action paper in May 2018.

He was also responsible for a second action paper, “Psychiatric Management of the Impact of Racism on Social and Clinical Events,” which passed at the same May 2018 assembly. Dr. Bell agreed to coauthor this paper, which was only fitting since the paper was a further elaboration of his efforts with the APA Caucus of Black Psychiatrists to implore the APA to acknowledge the deleterious effects of racism on both the victim and perpetrator.

While researching this topic, I had come across his 1980 article, Racism: A Symptom of the Narcissistic Personality Disorder (J Nat Med Assoc. 1980 Jul;72[7]:661-5), in which Dr. Bell applied psychoanalytic theory to posit that racism is one psychic derivative through which narcissism may manifest itself.

Although he was not formally trained as a psychoanalyst, he had benefited from strong psychoanalytic supervision at the Illinois State Psychiatric Institute, a training program of the University of Illinois at Chicago. He wrote confidently and clearly, applying self-psychology principles. He had the gravitas to write and speak about a range of topics, from neuroscience, psychotherapy, medical management of illness, and mental health advocacy. His 387-page curriculum vitae of 500+ articles, chapters, and books on mental health issues is a catalog of evidence that he had given thought to just about any topic along the spectrum of psychiatry and beyond.

In July 2018, after leaving a performance of “Hamilton” at the Kennedy Center, a lyric from the song “Non-Stop” stayed with me:

Why do you write like you’re running out of time?

(Why do you write like you’re running out of time?)

Write day and night like you’re running out of time?

The pace at which he read, wrote, lectured, researched, collaborated, and served on committees reminded me of the prodigious work of the former Secretary of the Treasury. When I shared this with Dr. Bell, he volunteered that he wrote to clear his mind. I suggested that, like other true writers, it seemed that he had to write. He did not disagree.

Courtesy Dr. Constance E. Dunlap

Dr. Bell and his peers applied their education and training to improve clinical care for all, to decrease health inequities, and to eliminate disparities. It is evident that he loved his people and committed his life to addressing the needs of marginalized communities, those without the benefit of abundant resources, and those disproportionately affected by violence and trauma. As he stated in his last book, Fetal Alcohol Exposure in the African-American Community:

“I should add, my main concern is African American people living within the United States of America where in one community the rate of Fetal Alcohol Exposure is 388/1,000 people. ... However, this problem extends much further. Fetal Alcohol Exposure (FAE) is increasingly being found to (be) problematic in people of color around the world: Native Americans in Canada ... Aboriginal people in Australia ... and various tribes of people on the continent of Africa. ... Lastly, while the problem of Fetal Alcohol Exposure seems to be disproportionately affecting people of color, it also affects people who lack pigment in their skin. For example, FAE is a problem in Russia. From a public health perspective, so often people of color are like the proverbial “canary in a coal mine,” i.e., if there is poisonous gas in the coal mine, the canary will die first, warning the miners that they need to do something about it.”

Courtesy Dr. Constance E. Dunlap

However, it would be a profound mistake to conclude that his work was restricted to black and brown communities. Dr. Bell was a Distinguished Lifetime Fellow of the American Psychiatric Association and a Lifetime Fellow of the American College of Psychiatrists. He was a founding member of the board of directors of the National Commission on Correctional Health, and a member of prominent work groups of the National Institutes of Mental Health and the National Academy of Medicine (formerly the Institute of Medicine). And Dr. Bell’s mentees and students transcend generations, race, religions, professional disciplines, and national boundaries.

Because Dr. Bell was grounded and never forgot his roots, it was in these professional society circles that he ensured that clinicians with more privilege and limited or no exposure to communities of color were educated about the needs of those he treated. Without exposure to Carl Bell, it is likely that many of our psychiatric colleagues would remain unaware of both the brilliant dynamic resources and enormous challenges that are found in the black community and communities of color. By sharing his work with the house of medicine, he obviated the excuse of doing nothing because of ignorance.

Courtesy Dr. Constance E. Dunlap

I last saw Dr. Bell in San Francisco toward the end of the 2019 annual APA meeting. He had received the APA’s Adolf* Meyer Award for lifetime achievement. Afterward, I joined him for a dim sum lunch in Chinatown with two of his colleagues and Joseph Calhoun, his mentee in the APA’s Black Men in Psychiatry Early Pipeline Program. As we walked back to our respective hotels, we paused at what is now the Chinese Affirmative Action Center. We learned that this site had been the home of one of Dr. Bell’s former martial arts instructors. As Dr. Bell recounted his martial arts training, the reverence for his sensei was evident in his eyes.

When I reflect on how much I learned from and about Carl Bell in such a short period of time, I realize that he was one of those people who was so present and so astute that he allowed you to know him while he was giving.

So, how do we honor someone who gave so much of himself? When I now think of the lyric from “Hamilton” – “Why do you write like you’re running out of time?” – I realize that we get it twisted when we associate running out of time with our elders and their phase of life. It was not Carl Bell who was running out of time. He had been extraordinarily respectful of the space, time, and energy allotted to him in his lifetime. He would say, “People squander their personal resources.” He certainly had not squandered his.

As we reflect and mourn his passing, we will hear about his candor, authenticity, integrity, discipline, reliability, dedication, and serving spirit. This is called character.

Dr. Bell was beyond generous with his life, and it is going to take decades, if not more, for us to digest the compendium of knowledge that he left behind. I ask you: How will you use that knowledge to advance the causes he so diligently devoted his life to solving?

To Carl Compton Bell, I say, Well done. Thank you. And, rest now my dear brother.
 

Dr. Dunlap, a psychiatrist and psychoanalyst who practices in Washington, is a Washington Psychiatric Society representative to the APA Assembly, a past president of the Washington Psychiatric Society, and clinical professor of psychiatry and behavioral sciences at George Washington University, Washington. She is interested in the role “difference” – race, culture, and ethnicity – plays in interpersonal relationships and group dynamics.

*This column was updated 9/3/2019.

With the heart of a child and the spirit of a warrior, Carl Bell always spoke his truth. And, he did so in his own inimitable way. Sporting his signature dark brown wide-brim leather cowboy hat or NMA (National Medical Association) baseball cap, aviator sunglasses, and accompanying Superman belt buckle, Carl Compton Bell, MD, – psychiatrist, researcher, mental health advocate, father, grandfather, friend, colleague, pioneer, and servant – was driven by a deep commitment to serve others.

As those who truly knew him can attest, it is not hyperbole to say that Carl Compton Bell was one of the most genuine, brilliant, and humble physicians of our professional community and time.

My collaboration and friendship began with Dr. Bell began during the summer of 2016 as I was preparing for the 2017 Washington Psychiatric Society’s (WPS) Presidential Symposium at Saint Elizabeths Hospital. As president of WPS, I had chosen gun violence as my topic and sought out Dr. Bell because of his work on the South Side of Chicago, where he had devoted himself, becoming an internationally known clinician, researcher, and mental health advocate for those personally affected by violence and trauma. He immediately accepted.

In his presentation, “Gun Violence, Urban Youth and Mental Illness,” he reviewed his research on the neurocognitive behavioral effects of prenatal exposure to alcohol and its relation to the neurodevelopmental dynamics of youth violence, intimate partner violence, and mass shootings. Dr. Bell suggested that the relationship between prenatal exposure to alcohol and the diagnosis of numerous psychiatric conditions had been underestimated in the medical community. He eventually summarized his work in Fetal Alcohol Exposure in the African-American Community, published by Third World Press (2018). This vital resource not only summarizes in plain language the scope of the problem of prenatal alcohol exposure but is a narrative of Carl Bell’s life journey.

After the symposium, he would send articles, while warning, “I can bombard you with stuff.” Sometimes we would not speak for weeks at a time while I digested the resources he had shared. However, whenever I picked up the phone to call and respond to what he had provided, he would answer the phone, “Yessssss?” – as if he were anticipating my call and was ready to address any queries or comments I might have. Even when he were about to board a plane or charting – after making rounds on his patients while listening to the music of James Brown – he would answer the phone, even if only to coordinate a more mutually convenient time to connect.

During the process of digesting the plethora of articles and resources he provided on prenatal fetal alcohol exposure, including the 1996 Institute of Medicine’s report and the American Medical Association’s 2017 resolution supporting the addition of adequate amounts of choline to prenatal vitamins, I found myself immersed in neuroscience topics, such as the role of neuronal acetylcholine receptor subunit alpha-7 in the formation of neurotransmitters, the strengthening of cell membranes, and the promotion of proper brain and spinal cord development. Dr. Bell spoke authoritatively about the neuroscience and the public health implications. One of his mantras was “Where is the data? You’ve got to have data.”

Courtesy Dr. Constance E. Dunlap

The information that he shared became the foundation of the action paper calling for the American Psychiatric Association (APA) to endorse the AMA’s resolution supporting the addition of adequate amounts (450 mg/d for pregnant women) of phosphatidylcholine to prenatal vitamins. The APA Assembly passed this action paper in May 2018.

He was also responsible for a second action paper, “Psychiatric Management of the Impact of Racism on Social and Clinical Events,” which passed at the same May 2018 assembly. Dr. Bell agreed to coauthor this paper, which was only fitting since the paper was a further elaboration of his efforts with the APA Caucus of Black Psychiatrists to implore the APA to acknowledge the deleterious effects of racism on both the victim and perpetrator.

While researching this topic, I had come across his 1980 article, Racism: A Symptom of the Narcissistic Personality Disorder (J Nat Med Assoc. 1980 Jul;72[7]:661-5), in which Dr. Bell applied psychoanalytic theory to posit that racism is one psychic derivative through which narcissism may manifest itself.

Although he was not formally trained as a psychoanalyst, he had benefited from strong psychoanalytic supervision at the Illinois State Psychiatric Institute, a training program of the University of Illinois at Chicago. He wrote confidently and clearly, applying self-psychology principles. He had the gravitas to write and speak about a range of topics, from neuroscience, psychotherapy, medical management of illness, and mental health advocacy. His 387-page curriculum vitae of 500+ articles, chapters, and books on mental health issues is a catalog of evidence that he had given thought to just about any topic along the spectrum of psychiatry and beyond.

In July 2018, after leaving a performance of “Hamilton” at the Kennedy Center, a lyric from the song “Non-Stop” stayed with me:

Why do you write like you’re running out of time?

(Why do you write like you’re running out of time?)

Write day and night like you’re running out of time?

The pace at which he read, wrote, lectured, researched, collaborated, and served on committees reminded me of the prodigious work of the former Secretary of the Treasury. When I shared this with Dr. Bell, he volunteered that he wrote to clear his mind. I suggested that, like other true writers, it seemed that he had to write. He did not disagree.

Courtesy Dr. Constance E. Dunlap

Dr. Bell and his peers applied their education and training to improve clinical care for all, to decrease health inequities, and to eliminate disparities. It is evident that he loved his people and committed his life to addressing the needs of marginalized communities, those without the benefit of abundant resources, and those disproportionately affected by violence and trauma. As he stated in his last book, Fetal Alcohol Exposure in the African-American Community:

“I should add, my main concern is African American people living within the United States of America where in one community the rate of Fetal Alcohol Exposure is 388/1,000 people. ... However, this problem extends much further. Fetal Alcohol Exposure (FAE) is increasingly being found to (be) problematic in people of color around the world: Native Americans in Canada ... Aboriginal people in Australia ... and various tribes of people on the continent of Africa. ... Lastly, while the problem of Fetal Alcohol Exposure seems to be disproportionately affecting people of color, it also affects people who lack pigment in their skin. For example, FAE is a problem in Russia. From a public health perspective, so often people of color are like the proverbial “canary in a coal mine,” i.e., if there is poisonous gas in the coal mine, the canary will die first, warning the miners that they need to do something about it.”

Courtesy Dr. Constance E. Dunlap

However, it would be a profound mistake to conclude that his work was restricted to black and brown communities. Dr. Bell was a Distinguished Lifetime Fellow of the American Psychiatric Association and a Lifetime Fellow of the American College of Psychiatrists. He was a founding member of the board of directors of the National Commission on Correctional Health, and a member of prominent work groups of the National Institutes of Mental Health and the National Academy of Medicine (formerly the Institute of Medicine). And Dr. Bell’s mentees and students transcend generations, race, religions, professional disciplines, and national boundaries.

Because Dr. Bell was grounded and never forgot his roots, it was in these professional society circles that he ensured that clinicians with more privilege and limited or no exposure to communities of color were educated about the needs of those he treated. Without exposure to Carl Bell, it is likely that many of our psychiatric colleagues would remain unaware of both the brilliant dynamic resources and enormous challenges that are found in the black community and communities of color. By sharing his work with the house of medicine, he obviated the excuse of doing nothing because of ignorance.

Courtesy Dr. Constance E. Dunlap

I last saw Dr. Bell in San Francisco toward the end of the 2019 annual APA meeting. He had received the APA’s Adolf* Meyer Award for lifetime achievement. Afterward, I joined him for a dim sum lunch in Chinatown with two of his colleagues and Joseph Calhoun, his mentee in the APA’s Black Men in Psychiatry Early Pipeline Program. As we walked back to our respective hotels, we paused at what is now the Chinese Affirmative Action Center. We learned that this site had been the home of one of Dr. Bell’s former martial arts instructors. As Dr. Bell recounted his martial arts training, the reverence for his sensei was evident in his eyes.

When I reflect on how much I learned from and about Carl Bell in such a short period of time, I realize that he was one of those people who was so present and so astute that he allowed you to know him while he was giving.

So, how do we honor someone who gave so much of himself? When I now think of the lyric from “Hamilton” – “Why do you write like you’re running out of time?” – I realize that we get it twisted when we associate running out of time with our elders and their phase of life. It was not Carl Bell who was running out of time. He had been extraordinarily respectful of the space, time, and energy allotted to him in his lifetime. He would say, “People squander their personal resources.” He certainly had not squandered his.

As we reflect and mourn his passing, we will hear about his candor, authenticity, integrity, discipline, reliability, dedication, and serving spirit. This is called character.

Dr. Bell was beyond generous with his life, and it is going to take decades, if not more, for us to digest the compendium of knowledge that he left behind. I ask you: How will you use that knowledge to advance the causes he so diligently devoted his life to solving?

To Carl Compton Bell, I say, Well done. Thank you. And, rest now my dear brother.
 

Dr. Dunlap, a psychiatrist and psychoanalyst who practices in Washington, is a Washington Psychiatric Society representative to the APA Assembly, a past president of the Washington Psychiatric Society, and clinical professor of psychiatry and behavioral sciences at George Washington University, Washington. She is interested in the role “difference” – race, culture, and ethnicity – plays in interpersonal relationships and group dynamics.

*This column was updated 9/3/2019.

Approximately 17% to 25% of all softtissue sarcomas (STS) are liposarcomas, making liposarcoma the most common type of STS.¹ The 2013 World Health Organization (WHO) classification separates liposarcoma into 4 histologic subtypes: atypical lipomatous tumor/well-differentiated (ALT/ WDLPS), dedifferentiated (DDLPS), myxoid, and pleomorphic.² Each subtype has unique histology, morphology, and natural history. WDLPS and DDLPS are the most common histologic subtypes, comprising approximately 50% of all sarcomas that arise in the retroperitoneum.³ DDLPS represents 18% of all liposarcomas, making it the second most common subtype of liposarcoma.⁴

In 1979, DDLPS was first characterized.⁵ Most (90%) cases of DDLPS present de novo, whereas the other 10% transform from preexisting low-grade WDLPS.² DDLPSs are formed by an amplification of 12q14-15 involving the MDM2 gene.⁴ These malignancies most commonly present in the retroperitoneum as a large painless mass, consisting of both fatty and nonfatty components.² Primary site has been previously reported as a major prognostic factor for DDLPSs, with retroperitoneal DDLPSs demonstrating the worst prognosis.6 DDLPSs have a high risk of local recurrence, with some reports estimating recurrence rates approaching 40%.² Overall mortality at 5 years for DDLPS is estimated to be between 30% and 40%.⁴

Previous literature has determined that median income, race, health insurance, and facility type are related to survival outcomes for patients with DDLPS.7-9 When comparing the most common types of cancers, residents of poorer US counties consistently had a higher risk of mortality than residents in affluent US counties, and all racial minorities showed worse survival outcomes when compared with white patients.⁷ Differences in survival outcomes have been reported in patients attending different treatment facilities for other cancers including pancreatic cancers, glioblastomas, and oral cancers, with multiple studies concluding that academic and research programs are associated with the longest survival outcomes.^10-12 For many cancers, insurance status has been shown to be a significant prognostic factor, with private insurance typically resulting in the best prognosis.^8,9

The goal of this retrospective study was to assess the prognostic effects of socioeconomic variables on the overall survival (OS) probabilities in a large cohort of DDLPS patients in order to inform clinicians about a potentially at-risk population.

Method

The National Cancer Database (NCDB) was created by the Commission on Cancer (CoC) of the American College of Surgeons and the American Cancer Society. The NCDB is the largest cancer database in the US and includes data on almost 70% of US patients with cancer. CoC-accredited cancer programs add data on patients with cancer to the NCDB. The authors accessed the NCDB data through the use of the NCDB Participant Use File program.

Patients’ data from 2004 through 2015 were abstracted. Only patients with the International Classification of Diseases for Oncology histology code 8858, corresponding to DDLPS, were analyzed. Patients with other comorbid malignant tumors were excluded to accurately capture the true survival rates for DDLPS. Variables analyzed included age, sex, race, insurance status, treatment facility type, median household income by zip code, and percentage of adults in the patient’s zip code with no high school (HS) education.

Median survival, 5- and 10-year OS probabilities, and Kaplan-Meier survival curves were calculated for multiple variables, specifically race, insurance status, treatment facility type, median family income, and percentage of adults without a HS degree. Both 5- and 10-year OS probabilities were determined by race with the patients separated into white, African American, Asian, American Indian/Alaska Native (AI/AN), and Asian Indian or Pakistani groups. Our study categorized Chinese, Japanese, Filipino, Hmong, Korean, Vietnamese, Thai, Guamanian, Asian not otherwise specified, and other Asian ethnicity patients together into one collective Asian group. Insurance status was classified into Medicare, Medicaid, other government insurance, and private insurance groups. Other government insurance consisted of US Department of Veterans Affairs, Indian Health Service, Public Health Service, and other government health care programs. Further analysis could not be performed into the distribution of the other government insurance variable.

Facility types were divided into 4 groups: community, comprehensive community, academic/ research, and integrated network cancer treatment facilities. Median income quartiles and the percentage of adults with no high school degree were estimated by comparison of the patient’s zip code with US Census Bureau data. Median household income was separated into 4 groups, including lowest level of household income (< $38,000), low level of household income ($38,000 to $47,999), moderate level of household income ($48,000 to $62,999), and highest level of household income (≥ $63,000). The percentages of adults with no high school degree were divided into 4 groups: lowest level of HS education (≥ 21% ), low level of HS education (13.0% to 20.9%), moderate level of HS education (7.0% to 12.9%), and highest level of HS education (≤ 7%). The 5- and 10-year survival probabilities were calculated using the number of months between the date of diagnosis and the date of death or last known contact.

Continuous variables are presented as median and interquartile range (IQR) whereas categorical variables are presented as frequencies and proportion. IBM SPSS version 25.0 was used to produce Kaplan-Meier survival curves and descriptive statistics. This study used Kaplan- Meier survival tables and log-rank tests to analyze both the 5- and 10-year OS rates for the 5 variables listed above. This study also used a multivariable Cox regression model that accommodated the correlative nature of outcomes within facilities to study the association of the treatment facility type and other socioeconomic factors, while controlling for age, race (which was collapsed into 3 categories), sex, primary site, tumor stage, and treatment approaches. The proportional hazards assumption was individually checked for all pertinent variables. Any patient records that were missing data were excluded from the multivariable Cox regression model, which was analyzed with SAS version 9.4 (Cary, NC). P < 0.05 was used to indicate statistical significance for all analyses.

Results

Table 1 provides descriptive analysis for demographic characteristics of the 3573 patients including age, sex, and race. The median age at diagnosis was 64 years. There were 1073 more men (65%) than women (35%) in this analysis. Whites were the predominant racial category, comprising 87.7% of the patient population, followed by African Americans (6.5%) and Asians (2.5%).

Socioeconomic Variables

The largest proportion of the patient population (45.5%) had private insurance (Table 2). Medicare came in a close second covering almost 42.2% of the population, followed by Medicaid (5.0%), uninsured (2.8%), and other government insurance (1.5%). About half (53.7%) of the patients were treated at academic or research facilities, while the fewest number of patients (5.2%) underwent treatment at community cancer facilities. The largest percentage (36.6%) of patients lived in zip codes with the highest level of median household income, while 26.0% and 22.3% had moderate and low levels of income, respectively. About 14% of patients lived within an area of the lowest level of income. Similarly, almost 15% of patients lived in an area of lowest level of HS education. The greatest percentage of the patient population (34.5%) lived in a zip code with moderate level of HS education. Surgery was the most common treatment modality with 90.8% of the cohort undergoing surgery, while 35.4% and 16.5% were treated with radiation and chemotherapy, respectively (some patients received more than one type of treatment modality).

Survival Data

Survival data were available for 3112 patients. Kaplan-Meier survival curves were used to analyze OS according to insurance status, racial background, treatment facility type, median family income, and percentage of adults with no high school education. Overall 5- and 10- year OS probabilities were 51.5% and 34.8%, respectively, while the median OS (SD) was 63.57 (2.8) months (Table 3).

Private insurance showed significantly higher 5- and 10-year OS probabilities and median OS: 5-year OS was 61.2%, 10-year OS was 47.2%, and median survival (SD) was 101.2 (8.2) months compared with that of all other insurance groups (Medicare, Medicaid, other government insurance, and uninsured) (Figure 1). These other insurance types were fairly similar in their 5-year and median OS, but surprisingly, patients with no insurance had the second longest 10-year OS. The difference between the 5-year OS probabilities of private insurance compared with an average of the other insurances was 15.1%, which had almost doubled to 28.5% at 10 years, with a median OS difference of almost 5 years (56 months; data not shown).

Using the Kaplan-Meier survival curve, Asian Indians had the longest 5-year OS probability of 77.9% and African Americans had the longest 10-year OS probability of 40.6%. However, Asians as a group demonstrated the longest median (SD) OS outcome with 119.8 (47.8) months (Figure 2).

Overall, academic/research programs had the longest median OS and 5-year OS probability (SD) of 66.6 (4.5) months and 52.6%, respectively (Figure 3). Comprehensive community cancer programs and integrated network cancer programs had nearly identical 10-year OS rates (35.2% vs 35.1%, respectively). Community cancer programs had the worst 5- and 10-year OS probabilities (41.1% and 21.8%, respectively).

The top 2 income quartiles combined to demonstrate the longest median, 5-year, and 10-year OS probabilities and were very similar. Patients living in a zip code with the highest income level had the longest 5-year OS rates of 54.3%, while patients living in zip codes with a moderate income level had the longest 10-year OS at 39.3% and the longest median OS of about 71 months. Patients with the lowest level of median household income had the worst 5-year OS rates (48.3%) and a median (SD) OS of 53.4 (5.4) months (Figure 4).

A Kaplan-Meier curve for percentage of adults without a HS degree is displayed in Figure 5. Zip codes with the highest level of education had the longest 5-year OS rates and median (SD) OS of 55.3% and 70.9 (4.8) months, respectively. The longest 10-year OS outcomes at 38.1% were found in patients who lived in areas of low-education levels. The worst 5- and 10- year OS outcomes and median OS were found in the least educated zip codes.

Results from the Cox regression model of OS are displayed in Table 4. Race and ethnicity, zip code-level median household income, and zip code-level education were not associated with OS. Patients with no insurance had an increased risk of death (hazard ratio [HR], 1.84; 95% CI, 1.17-2.88; P < .01) when compared with patients with private insurance. Patients with other government insurance also had an increased risk of death (HR, 2.12; 95% CI, 1.27-3.54; P < .01) when compared with patients with private insurance while controlling for all other variables. Patients with Medicare had a decreased risk of death when compared with patients with other government insurance and no insurance (HR, 0.53; 95% CI, 0.31-0.92; P = .02 and HR, 0.62; 95% CI, 0.38-0.99; P = .05, respectively). Patients treated at academic centers had better OS when compared with patients treated at comprehensive treatment centers (HR, 0.77; 95% CI, 0.65-0.92;P < .01) and community treatment centers (HR, 0.62; 95% CI, 0.44-0.86; P < .01).

Discussion

This study is the largest study to date that specifically studies the type of treatment facilities and socioeconomic factors, including insurance status, race, income, and education, and how they affect survival of DDLPS. The overall 5- and 10-year OS probabilities for DDLPS in this study were 51.5% and 34.8%, respectively, with median OS of 63.6 months. These results were more encouraging than previous reports, which found a 5-year survival probability of 36.5% and a median OS of 45 months.^13,14

The largest age grouping was aged 61 to 80 years (48.9% of the cohort), and the median age at diagnosis was 64 years. DDLPSs most typically present between the ages of 50 and 70 years.¹⁵ Our cohort was 65% male. Previous studies have indicated that DDLPSs affect the sexes equally; however, another study showed a similar male predominance (68.8%) at the MD Anderson Cancer Center in Houston, Texas.^13,16

In our study, approximately 88% of patients were white, 6.5% were African American, and 2.5% were Asian, which differed from a previous study of 84 patients that had a 78.6% white, 4.8% Asian, and 1.2% African American patient population.¹⁴

Asian Indian or Pakistani patients had the best 5-year OS probability at 77.9%, followed by African American (57.2%), Asian (51.6%), AI/AN (51.4%), and white patients (50.9%). This trend had disappeared by 10 years and Asian, AI/AN, African American, and Asian Indian or Pakistani groups all demonstrated longer median OS than did white patients. In fact, Asian patients had the longest median OS at 119.8 months, which was almost double that of white patients with the lowest median OS of 61.2 months. This finding is contrary to previous studies, which reported that racial minorities typically had worse OS outcomes when compared with white patients in different types of cancer.^7,17 Notably, these findings were not statistically significant in our current study in the log-rank or multivariable analyses.

Private insurance was the most common form of insurance followed in decreasing order by Medicare, Medicaid, uninsured, and other government insurance. About 42% of the cohort had Medicare, which is a federally funded US insurance program designated for patients aged ≥ 65 years and certain younger patients with disabilities.

Patients with private insurance demonstrated the longest OS, essentially twice the median OS of all other insured groups at 101 months. Medicare had the worst 5-year OS probability and median OS of all groups. A previous study of 77 patients with DDLPS reported that patients aged > 65 years had reduced OS.13 Medicare patients in this study were older, with a mean and median age at DDLPS diagnosis of 71 and 72 years, respectively, while private insurance had a mean and median age at diagnosis of 56 and 57 years, respectively. Medicare inherently covers older patients and this age difference could account for the decrease in overall survival.

Improved OS for privately insured patients was most notable compared with the uninsured or patients with other government insurance. Uninsured patients had an 83.7% increased risk of mortality when compared with patients with private insurance. When compared with patients with private insurance, patients with other government insurance had an 111.5% increased risk of mortality. Comparing patients with Medicare vs patients with no insurance or other government insurance, there was a decreased risk of mortality of 38.5% and 46.6%, respectively. This decreased OS in patients with other government insurance could be related to the choice of treatment facility, because only 31% of the patients with other government insurance went to academic or research centers when compared with the 58.4% and 50.8% of patients with private and Medicare insurance treated there (data not shown). Such centers often have access to more advanced technology and protocols that may not be available at other treatment facilities.

A little more than half of the patients in the cohort went to an academic or research center for treatment (53.7%); comprehensive community cancer programs were the second most common treatment facility at 28%. Patients treated at academic or research centers demonstrated the best outcomes with a 5-year OS of 52.6%, followed in decreasing order by comprehensive community cancer programs (49.7%), integrated network cancer programs (48.8%), and community cancer programs (41.1%). In our patient cocohort, patients treated at an academic/research center had slightly decreased 10-year OS rates compared with those patients treated at a comprehensive community cancer program, although the median OS for the academic/research centers were still the highest of all treatment facilities.

Treatment options varied significantly by facility, and the number of patients treated surgically followed a similar trend, with 92% undergoing surgery as the primary treatment at academic or research programs compared with 89% at comprehensive cancer programs and 82.7% at community cancer programs (data not shown). Another potential explaination for differing OS outcomes across facilities is the surgical margin outcome. Surgeries performed at community cancer programs or comprehensive cancer programs resulted with no residual tumor in 36% and 40% of cases, respectively, whereas cases performed at academic or research programs resulted with no residual tumor in 47% of cases (data not shown). Regardless, multivariate analysis demonstrated a marked decrease in the chance of mortality when comparing treatment received at academic facility centers with that received at comprehensive cancer centers (22.9%) and community cancer centers (38.3%) (data not shown).

A recent study demonstrated improved outcomes for patients with retroperitoneal or extremity STS treated at high-volume treatment centers.¹⁸ Patients treated at high-volume centers were found to have an 8% decreased risk of death compared with patients treated at low-volume centers. Notably, they found highvolume academic centers demonstrated the strongest improvement in survival, while highvolume community centers showed decreased survival.¹⁸ Similarly, we found that patients treated at academic/research institutions had improved 5-year OS and greater median OS than did patients treated at community cancer programs or comprehensive community cancer programs.

The top 2 income quartiles (≥ $48,000) combined to demonstrate the longest median, 5-year, and 10-year OS and were fairly similar between the quartiles. Patients living in zip codes with a median income of $38,000 to $47,999 had the worst 5-year OS and median OS. The log-rank analysis showed statistical evidence of differences in survival associated with income, but within the context of the multivariable analysis, there was no remaining evidence of a difference.

The longest 5-year OS outcomes were seen in patients living in zip codes with the highest level of education (55.3%). However, the difference in OS was not statistically significant using either the log-rank analysis or multivariate analysis.

Limitations

This study has certain inherent limitations in using a retrospective design and a large database such as the NCDB. Many different pathologists at CoC-accredited cancer programs perform the pathology that contributes to the data in the NCDB. There was no pathological review of these findings, which could potentially introduce error into the findings of this study. With the NCDB, potential selection bias is possible because patients in the database are added only from CoC-accredited cancer programs. This risk is minimized because NCDB contains data on most newly diagnosed cancer patients in the US. Further potential risks, which are unable to be controlled for, include potential interobserver error and data that may be incompletely, improperly, or inaccurately recorded from the patients’ charts. Without patient-specific information regarding income and education, it is challenging to utilize zip codes to estimate socioeconomic status and educational level. Even though a patient may live in a zip code identified with specific economic and educational characteristics, that patient may not share those characteristics. Furthermore, patients with Medicare tend to be older than patients with other forms of insurance, which limits the significance of comparisons across insurance groups. A future SEER (Surveillance, Epidemiology, and End Results) program study to confirm this study’s results and the effects of socioeconomic variables on DDLPS would be an excellent followup study.

Conclusion

This study used a large cohort of patients with DDLPS to study the effects of treatment facility, insurance status, and socioeconomic variables on survival outcomes. Although insurance status, median household income, and treatment facility were associated with differences in median OS and 5- and 10-year OS probabilities, evidence for a difference remained for only insurance status and facility type within the context of a multivariable analysis irrespective of age, race, sex, insurance status, education, and median income. Patients with private insurance and Medicaid had a decreased risk of mortality compared with other government insurance and no insurance. Patients receiving treatment at academic research programs had the highest median and 5-year OS of 66.6 months and 52.6%, respectively. Patients receiving treatment at academic centers had improved survival outcomes with a decrease in mortality of 23% and 38% compared to comprehensive or community cancer programs.

Approximately 17% to 25% of all softtissue sarcomas (STS) are liposarcomas, making liposarcoma the most common type of STS.¹ The 2013 World Health Organization (WHO) classification separates liposarcoma into 4 histologic subtypes: atypical lipomatous tumor/well-differentiated (ALT/ WDLPS), dedifferentiated (DDLPS), myxoid, and pleomorphic.² Each subtype has unique histology, morphology, and natural history. WDLPS and DDLPS are the most common histologic subtypes, comprising approximately 50% of all sarcomas that arise in the retroperitoneum.³ DDLPS represents 18% of all liposarcomas, making it the second most common subtype of liposarcoma.⁴

In 1979, DDLPS was first characterized.⁵ Most (90%) cases of DDLPS present de novo, whereas the other 10% transform from preexisting low-grade WDLPS.² DDLPSs are formed by an amplification of 12q14-15 involving the MDM2 gene.⁴ These malignancies most commonly present in the retroperitoneum as a large painless mass, consisting of both fatty and nonfatty components.² Primary site has been previously reported as a major prognostic factor for DDLPSs, with retroperitoneal DDLPSs demonstrating the worst prognosis.6 DDLPSs have a high risk of local recurrence, with some reports estimating recurrence rates approaching 40%.² Overall mortality at 5 years for DDLPS is estimated to be between 30% and 40%.⁴

Previous literature has determined that median income, race, health insurance, and facility type are related to survival outcomes for patients with DDLPS.7-9 When comparing the most common types of cancers, residents of poorer US counties consistently had a higher risk of mortality than residents in affluent US counties, and all racial minorities showed worse survival outcomes when compared with white patients.⁷ Differences in survival outcomes have been reported in patients attending different treatment facilities for other cancers including pancreatic cancers, glioblastomas, and oral cancers, with multiple studies concluding that academic and research programs are associated with the longest survival outcomes.^10-12 For many cancers, insurance status has been shown to be a significant prognostic factor, with private insurance typically resulting in the best prognosis.^8,9

The goal of this retrospective study was to assess the prognostic effects of socioeconomic variables on the overall survival (OS) probabilities in a large cohort of DDLPS patients in order to inform clinicians about a potentially at-risk population.

Method

The National Cancer Database (NCDB) was created by the Commission on Cancer (CoC) of the American College of Surgeons and the American Cancer Society. The NCDB is the largest cancer database in the US and includes data on almost 70% of US patients with cancer. CoC-accredited cancer programs add data on patients with cancer to the NCDB. The authors accessed the NCDB data through the use of the NCDB Participant Use File program.

Patients’ data from 2004 through 2015 were abstracted. Only patients with the International Classification of Diseases for Oncology histology code 8858, corresponding to DDLPS, were analyzed. Patients with other comorbid malignant tumors were excluded to accurately capture the true survival rates for DDLPS. Variables analyzed included age, sex, race, insurance status, treatment facility type, median household income by zip code, and percentage of adults in the patient’s zip code with no high school (HS) education.

Median survival, 5- and 10-year OS probabilities, and Kaplan-Meier survival curves were calculated for multiple variables, specifically race, insurance status, treatment facility type, median family income, and percentage of adults without a HS degree. Both 5- and 10-year OS probabilities were determined by race with the patients separated into white, African American, Asian, American Indian/Alaska Native (AI/AN), and Asian Indian or Pakistani groups. Our study categorized Chinese, Japanese, Filipino, Hmong, Korean, Vietnamese, Thai, Guamanian, Asian not otherwise specified, and other Asian ethnicity patients together into one collective Asian group. Insurance status was classified into Medicare, Medicaid, other government insurance, and private insurance groups. Other government insurance consisted of US Department of Veterans Affairs, Indian Health Service, Public Health Service, and other government health care programs. Further analysis could not be performed into the distribution of the other government insurance variable.

Facility types were divided into 4 groups: community, comprehensive community, academic/ research, and integrated network cancer treatment facilities. Median income quartiles and the percentage of adults with no high school degree were estimated by comparison of the patient’s zip code with US Census Bureau data. Median household income was separated into 4 groups, including lowest level of household income (< $38,000), low level of household income ($38,000 to $47,999), moderate level of household income ($48,000 to $62,999), and highest level of household income (≥ $63,000). The percentages of adults with no high school degree were divided into 4 groups: lowest level of HS education (≥ 21% ), low level of HS education (13.0% to 20.9%), moderate level of HS education (7.0% to 12.9%), and highest level of HS education (≤ 7%). The 5- and 10-year survival probabilities were calculated using the number of months between the date of diagnosis and the date of death or last known contact.

Continuous variables are presented as median and interquartile range (IQR) whereas categorical variables are presented as frequencies and proportion. IBM SPSS version 25.0 was used to produce Kaplan-Meier survival curves and descriptive statistics. This study used Kaplan- Meier survival tables and log-rank tests to analyze both the 5- and 10-year OS rates for the 5 variables listed above. This study also used a multivariable Cox regression model that accommodated the correlative nature of outcomes within facilities to study the association of the treatment facility type and other socioeconomic factors, while controlling for age, race (which was collapsed into 3 categories), sex, primary site, tumor stage, and treatment approaches. The proportional hazards assumption was individually checked for all pertinent variables. Any patient records that were missing data were excluded from the multivariable Cox regression model, which was analyzed with SAS version 9.4 (Cary, NC). P < 0.05 was used to indicate statistical significance for all analyses.

Results

Table 1 provides descriptive analysis for demographic characteristics of the 3573 patients including age, sex, and race. The median age at diagnosis was 64 years. There were 1073 more men (65%) than women (35%) in this analysis. Whites were the predominant racial category, comprising 87.7% of the patient population, followed by African Americans (6.5%) and Asians (2.5%).

Socioeconomic Variables

The largest proportion of the patient population (45.5%) had private insurance (Table 2). Medicare came in a close second covering almost 42.2% of the population, followed by Medicaid (5.0%), uninsured (2.8%), and other government insurance (1.5%). About half (53.7%) of the patients were treated at academic or research facilities, while the fewest number of patients (5.2%) underwent treatment at community cancer facilities. The largest percentage (36.6%) of patients lived in zip codes with the highest level of median household income, while 26.0% and 22.3% had moderate and low levels of income, respectively. About 14% of patients lived within an area of the lowest level of income. Similarly, almost 15% of patients lived in an area of lowest level of HS education. The greatest percentage of the patient population (34.5%) lived in a zip code with moderate level of HS education. Surgery was the most common treatment modality with 90.8% of the cohort undergoing surgery, while 35.4% and 16.5% were treated with radiation and chemotherapy, respectively (some patients received more than one type of treatment modality).

Survival Data

Survival data were available for 3112 patients. Kaplan-Meier survival curves were used to analyze OS according to insurance status, racial background, treatment facility type, median family income, and percentage of adults with no high school education. Overall 5- and 10- year OS probabilities were 51.5% and 34.8%, respectively, while the median OS (SD) was 63.57 (2.8) months (Table 3).

Private insurance showed significantly higher 5- and 10-year OS probabilities and median OS: 5-year OS was 61.2%, 10-year OS was 47.2%, and median survival (SD) was 101.2 (8.2) months compared with that of all other insurance groups (Medicare, Medicaid, other government insurance, and uninsured) (Figure 1). These other insurance types were fairly similar in their 5-year and median OS, but surprisingly, patients with no insurance had the second longest 10-year OS. The difference between the 5-year OS probabilities of private insurance compared with an average of the other insurances was 15.1%, which had almost doubled to 28.5% at 10 years, with a median OS difference of almost 5 years (56 months; data not shown).

Using the Kaplan-Meier survival curve, Asian Indians had the longest 5-year OS probability of 77.9% and African Americans had the longest 10-year OS probability of 40.6%. However, Asians as a group demonstrated the longest median (SD) OS outcome with 119.8 (47.8) months (Figure 2).

Overall, academic/research programs had the longest median OS and 5-year OS probability (SD) of 66.6 (4.5) months and 52.6%, respectively (Figure 3). Comprehensive community cancer programs and integrated network cancer programs had nearly identical 10-year OS rates (35.2% vs 35.1%, respectively). Community cancer programs had the worst 5- and 10-year OS probabilities (41.1% and 21.8%, respectively).

The top 2 income quartiles combined to demonstrate the longest median, 5-year, and 10-year OS probabilities and were very similar. Patients living in a zip code with the highest income level had the longest 5-year OS rates of 54.3%, while patients living in zip codes with a moderate income level had the longest 10-year OS at 39.3% and the longest median OS of about 71 months. Patients with the lowest level of median household income had the worst 5-year OS rates (48.3%) and a median (SD) OS of 53.4 (5.4) months (Figure 4).

A Kaplan-Meier curve for percentage of adults without a HS degree is displayed in Figure 5. Zip codes with the highest level of education had the longest 5-year OS rates and median (SD) OS of 55.3% and 70.9 (4.8) months, respectively. The longest 10-year OS outcomes at 38.1% were found in patients who lived in areas of low-education levels. The worst 5- and 10- year OS outcomes and median OS were found in the least educated zip codes.

Results from the Cox regression model of OS are displayed in Table 4. Race and ethnicity, zip code-level median household income, and zip code-level education were not associated with OS. Patients with no insurance had an increased risk of death (hazard ratio [HR], 1.84; 95% CI, 1.17-2.88; P < .01) when compared with patients with private insurance. Patients with other government insurance also had an increased risk of death (HR, 2.12; 95% CI, 1.27-3.54; P < .01) when compared with patients with private insurance while controlling for all other variables. Patients with Medicare had a decreased risk of death when compared with patients with other government insurance and no insurance (HR, 0.53; 95% CI, 0.31-0.92; P = .02 and HR, 0.62; 95% CI, 0.38-0.99; P = .05, respectively). Patients treated at academic centers had better OS when compared with patients treated at comprehensive treatment centers (HR, 0.77; 95% CI, 0.65-0.92;P < .01) and community treatment centers (HR, 0.62; 95% CI, 0.44-0.86; P < .01).

Discussion

This study is the largest study to date that specifically studies the type of treatment facilities and socioeconomic factors, including insurance status, race, income, and education, and how they affect survival of DDLPS. The overall 5- and 10-year OS probabilities for DDLPS in this study were 51.5% and 34.8%, respectively, with median OS of 63.6 months. These results were more encouraging than previous reports, which found a 5-year survival probability of 36.5% and a median OS of 45 months.^13,14

The largest age grouping was aged 61 to 80 years (48.9% of the cohort), and the median age at diagnosis was 64 years. DDLPSs most typically present between the ages of 50 and 70 years.¹⁵ Our cohort was 65% male. Previous studies have indicated that DDLPSs affect the sexes equally; however, another study showed a similar male predominance (68.8%) at the MD Anderson Cancer Center in Houston, Texas.^13,16

In our study, approximately 88% of patients were white, 6.5% were African American, and 2.5% were Asian, which differed from a previous study of 84 patients that had a 78.6% white, 4.8% Asian, and 1.2% African American patient population.¹⁴

Asian Indian or Pakistani patients had the best 5-year OS probability at 77.9%, followed by African American (57.2%), Asian (51.6%), AI/AN (51.4%), and white patients (50.9%). This trend had disappeared by 10 years and Asian, AI/AN, African American, and Asian Indian or Pakistani groups all demonstrated longer median OS than did white patients. In fact, Asian patients had the longest median OS at 119.8 months, which was almost double that of white patients with the lowest median OS of 61.2 months. This finding is contrary to previous studies, which reported that racial minorities typically had worse OS outcomes when compared with white patients in different types of cancer.^7,17 Notably, these findings were not statistically significant in our current study in the log-rank or multivariable analyses.

Private insurance was the most common form of insurance followed in decreasing order by Medicare, Medicaid, uninsured, and other government insurance. About 42% of the cohort had Medicare, which is a federally funded US insurance program designated for patients aged ≥ 65 years and certain younger patients with disabilities.

Patients with private insurance demonstrated the longest OS, essentially twice the median OS of all other insured groups at 101 months. Medicare had the worst 5-year OS probability and median OS of all groups. A previous study of 77 patients with DDLPS reported that patients aged > 65 years had reduced OS.13 Medicare patients in this study were older, with a mean and median age at DDLPS diagnosis of 71 and 72 years, respectively, while private insurance had a mean and median age at diagnosis of 56 and 57 years, respectively. Medicare inherently covers older patients and this age difference could account for the decrease in overall survival.

Improved OS for privately insured patients was most notable compared with the uninsured or patients with other government insurance. Uninsured patients had an 83.7% increased risk of mortality when compared with patients with private insurance. When compared with patients with private insurance, patients with other government insurance had an 111.5% increased risk of mortality. Comparing patients with Medicare vs patients with no insurance or other government insurance, there was a decreased risk of mortality of 38.5% and 46.6%, respectively. This decreased OS in patients with other government insurance could be related to the choice of treatment facility, because only 31% of the patients with other government insurance went to academic or research centers when compared with the 58.4% and 50.8% of patients with private and Medicare insurance treated there (data not shown). Such centers often have access to more advanced technology and protocols that may not be available at other treatment facilities.

A little more than half of the patients in the cohort went to an academic or research center for treatment (53.7%); comprehensive community cancer programs were the second most common treatment facility at 28%. Patients treated at academic or research centers demonstrated the best outcomes with a 5-year OS of 52.6%, followed in decreasing order by comprehensive community cancer programs (49.7%), integrated network cancer programs (48.8%), and community cancer programs (41.1%). In our patient cocohort, patients treated at an academic/research center had slightly decreased 10-year OS rates compared with those patients treated at a comprehensive community cancer program, although the median OS for the academic/research centers were still the highest of all treatment facilities.

Treatment options varied significantly by facility, and the number of patients treated surgically followed a similar trend, with 92% undergoing surgery as the primary treatment at academic or research programs compared with 89% at comprehensive cancer programs and 82.7% at community cancer programs (data not shown). Another potential explaination for differing OS outcomes across facilities is the surgical margin outcome. Surgeries performed at community cancer programs or comprehensive cancer programs resulted with no residual tumor in 36% and 40% of cases, respectively, whereas cases performed at academic or research programs resulted with no residual tumor in 47% of cases (data not shown). Regardless, multivariate analysis demonstrated a marked decrease in the chance of mortality when comparing treatment received at academic facility centers with that received at comprehensive cancer centers (22.9%) and community cancer centers (38.3%) (data not shown).

A recent study demonstrated improved outcomes for patients with retroperitoneal or extremity STS treated at high-volume treatment centers.¹⁸ Patients treated at high-volume centers were found to have an 8% decreased risk of death compared with patients treated at low-volume centers. Notably, they found highvolume academic centers demonstrated the strongest improvement in survival, while highvolume community centers showed decreased survival.¹⁸ Similarly, we found that patients treated at academic/research institutions had improved 5-year OS and greater median OS than did patients treated at community cancer programs or comprehensive community cancer programs.

The top 2 income quartiles (≥ $48,000) combined to demonstrate the longest median, 5-year, and 10-year OS and were fairly similar between the quartiles. Patients living in zip codes with a median income of $38,000 to $47,999 had the worst 5-year OS and median OS. The log-rank analysis showed statistical evidence of differences in survival associated with income, but within the context of the multivariable analysis, there was no remaining evidence of a difference.

The longest 5-year OS outcomes were seen in patients living in zip codes with the highest level of education (55.3%). However, the difference in OS was not statistically significant using either the log-rank analysis or multivariate analysis.

Limitations

This study has certain inherent limitations in using a retrospective design and a large database such as the NCDB. Many different pathologists at CoC-accredited cancer programs perform the pathology that contributes to the data in the NCDB. There was no pathological review of these findings, which could potentially introduce error into the findings of this study. With the NCDB, potential selection bias is possible because patients in the database are added only from CoC-accredited cancer programs. This risk is minimized because NCDB contains data on most newly diagnosed cancer patients in the US. Further potential risks, which are unable to be controlled for, include potential interobserver error and data that may be incompletely, improperly, or inaccurately recorded from the patients’ charts. Without patient-specific information regarding income and education, it is challenging to utilize zip codes to estimate socioeconomic status and educational level. Even though a patient may live in a zip code identified with specific economic and educational characteristics, that patient may not share those characteristics. Furthermore, patients with Medicare tend to be older than patients with other forms of insurance, which limits the significance of comparisons across insurance groups. A future SEER (Surveillance, Epidemiology, and End Results) program study to confirm this study’s results and the effects of socioeconomic variables on DDLPS would be an excellent followup study.

Conclusion

This study used a large cohort of patients with DDLPS to study the effects of treatment facility, insurance status, and socioeconomic variables on survival outcomes. Although insurance status, median household income, and treatment facility were associated with differences in median OS and 5- and 10-year OS probabilities, evidence for a difference remained for only insurance status and facility type within the context of a multivariable analysis irrespective of age, race, sex, insurance status, education, and median income. Patients with private insurance and Medicaid had a decreased risk of mortality compared with other government insurance and no insurance. Patients receiving treatment at academic research programs had the highest median and 5-year OS of 66.6 months and 52.6%, respectively. Patients receiving treatment at academic centers had improved survival outcomes with a decrease in mortality of 23% and 38% compared to comprehensive or community cancer programs.

Approximately 17% to 25% of all softtissue sarcomas (STS) are liposarcomas, making liposarcoma the most common type of STS.¹ The 2013 World Health Organization (WHO) classification separates liposarcoma into 4 histologic subtypes: atypical lipomatous tumor/well-differentiated (ALT/ WDLPS), dedifferentiated (DDLPS), myxoid, and pleomorphic.² Each subtype has unique histology, morphology, and natural history. WDLPS and DDLPS are the most common histologic subtypes, comprising approximately 50% of all sarcomas that arise in the retroperitoneum.³ DDLPS represents 18% of all liposarcomas, making it the second most common subtype of liposarcoma.⁴

In 1979, DDLPS was first characterized.⁵ Most (90%) cases of DDLPS present de novo, whereas the other 10% transform from preexisting low-grade WDLPS.² DDLPSs are formed by an amplification of 12q14-15 involving the MDM2 gene.⁴ These malignancies most commonly present in the retroperitoneum as a large painless mass, consisting of both fatty and nonfatty components.² Primary site has been previously reported as a major prognostic factor for DDLPSs, with retroperitoneal DDLPSs demonstrating the worst prognosis.6 DDLPSs have a high risk of local recurrence, with some reports estimating recurrence rates approaching 40%.² Overall mortality at 5 years for DDLPS is estimated to be between 30% and 40%.⁴

Previous literature has determined that median income, race, health insurance, and facility type are related to survival outcomes for patients with DDLPS.7-9 When comparing the most common types of cancers, residents of poorer US counties consistently had a higher risk of mortality than residents in affluent US counties, and all racial minorities showed worse survival outcomes when compared with white patients.⁷ Differences in survival outcomes have been reported in patients attending different treatment facilities for other cancers including pancreatic cancers, glioblastomas, and oral cancers, with multiple studies concluding that academic and research programs are associated with the longest survival outcomes.^10-12 For many cancers, insurance status has been shown to be a significant prognostic factor, with private insurance typically resulting in the best prognosis.^8,9

The goal of this retrospective study was to assess the prognostic effects of socioeconomic variables on the overall survival (OS) probabilities in a large cohort of DDLPS patients in order to inform clinicians about a potentially at-risk population.

Method

The National Cancer Database (NCDB) was created by the Commission on Cancer (CoC) of the American College of Surgeons and the American Cancer Society. The NCDB is the largest cancer database in the US and includes data on almost 70% of US patients with cancer. CoC-accredited cancer programs add data on patients with cancer to the NCDB. The authors accessed the NCDB data through the use of the NCDB Participant Use File program.

Patients’ data from 2004 through 2015 were abstracted. Only patients with the International Classification of Diseases for Oncology histology code 8858, corresponding to DDLPS, were analyzed. Patients with other comorbid malignant tumors were excluded to accurately capture the true survival rates for DDLPS. Variables analyzed included age, sex, race, insurance status, treatment facility type, median household income by zip code, and percentage of adults in the patient’s zip code with no high school (HS) education.

Median survival, 5- and 10-year OS probabilities, and Kaplan-Meier survival curves were calculated for multiple variables, specifically race, insurance status, treatment facility type, median family income, and percentage of adults without a HS degree. Both 5- and 10-year OS probabilities were determined by race with the patients separated into white, African American, Asian, American Indian/Alaska Native (AI/AN), and Asian Indian or Pakistani groups. Our study categorized Chinese, Japanese, Filipino, Hmong, Korean, Vietnamese, Thai, Guamanian, Asian not otherwise specified, and other Asian ethnicity patients together into one collective Asian group. Insurance status was classified into Medicare, Medicaid, other government insurance, and private insurance groups. Other government insurance consisted of US Department of Veterans Affairs, Indian Health Service, Public Health Service, and other government health care programs. Further analysis could not be performed into the distribution of the other government insurance variable.

Facility types were divided into 4 groups: community, comprehensive community, academic/ research, and integrated network cancer treatment facilities. Median income quartiles and the percentage of adults with no high school degree were estimated by comparison of the patient’s zip code with US Census Bureau data. Median household income was separated into 4 groups, including lowest level of household income (< $38,000), low level of household income ($38,000 to $47,999), moderate level of household income ($48,000 to $62,999), and highest level of household income (≥ $63,000). The percentages of adults with no high school degree were divided into 4 groups: lowest level of HS education (≥ 21% ), low level of HS education (13.0% to 20.9%), moderate level of HS education (7.0% to 12.9%), and highest level of HS education (≤ 7%). The 5- and 10-year survival probabilities were calculated using the number of months between the date of diagnosis and the date of death or last known contact.

Continuous variables are presented as median and interquartile range (IQR) whereas categorical variables are presented as frequencies and proportion. IBM SPSS version 25.0 was used to produce Kaplan-Meier survival curves and descriptive statistics. This study used Kaplan- Meier survival tables and log-rank tests to analyze both the 5- and 10-year OS rates for the 5 variables listed above. This study also used a multivariable Cox regression model that accommodated the correlative nature of outcomes within facilities to study the association of the treatment facility type and other socioeconomic factors, while controlling for age, race (which was collapsed into 3 categories), sex, primary site, tumor stage, and treatment approaches. The proportional hazards assumption was individually checked for all pertinent variables. Any patient records that were missing data were excluded from the multivariable Cox regression model, which was analyzed with SAS version 9.4 (Cary, NC). P < 0.05 was used to indicate statistical significance for all analyses.

Results

Table 1 provides descriptive analysis for demographic characteristics of the 3573 patients including age, sex, and race. The median age at diagnosis was 64 years. There were 1073 more men (65%) than women (35%) in this analysis. Whites were the predominant racial category, comprising 87.7% of the patient population, followed by African Americans (6.5%) and Asians (2.5%).

Socioeconomic Variables

The largest proportion of the patient population (45.5%) had private insurance (Table 2). Medicare came in a close second covering almost 42.2% of the population, followed by Medicaid (5.0%), uninsured (2.8%), and other government insurance (1.5%). About half (53.7%) of the patients were treated at academic or research facilities, while the fewest number of patients (5.2%) underwent treatment at community cancer facilities. The largest percentage (36.6%) of patients lived in zip codes with the highest level of median household income, while 26.0% and 22.3% had moderate and low levels of income, respectively. About 14% of patients lived within an area of the lowest level of income. Similarly, almost 15% of patients lived in an area of lowest level of HS education. The greatest percentage of the patient population (34.5%) lived in a zip code with moderate level of HS education. Surgery was the most common treatment modality with 90.8% of the cohort undergoing surgery, while 35.4% and 16.5% were treated with radiation and chemotherapy, respectively (some patients received more than one type of treatment modality).

Survival Data

Survival data were available for 3112 patients. Kaplan-Meier survival curves were used to analyze OS according to insurance status, racial background, treatment facility type, median family income, and percentage of adults with no high school education. Overall 5- and 10- year OS probabilities were 51.5% and 34.8%, respectively, while the median OS (SD) was 63.57 (2.8) months (Table 3).

Private insurance showed significantly higher 5- and 10-year OS probabilities and median OS: 5-year OS was 61.2%, 10-year OS was 47.2%, and median survival (SD) was 101.2 (8.2) months compared with that of all other insurance groups (Medicare, Medicaid, other government insurance, and uninsured) (Figure 1). These other insurance types were fairly similar in their 5-year and median OS, but surprisingly, patients with no insurance had the second longest 10-year OS. The difference between the 5-year OS probabilities of private insurance compared with an average of the other insurances was 15.1%, which had almost doubled to 28.5% at 10 years, with a median OS difference of almost 5 years (56 months; data not shown).

Using the Kaplan-Meier survival curve, Asian Indians had the longest 5-year OS probability of 77.9% and African Americans had the longest 10-year OS probability of 40.6%. However, Asians as a group demonstrated the longest median (SD) OS outcome with 119.8 (47.8) months (Figure 2).

Overall, academic/research programs had the longest median OS and 5-year OS probability (SD) of 66.6 (4.5) months and 52.6%, respectively (Figure 3). Comprehensive community cancer programs and integrated network cancer programs had nearly identical 10-year OS rates (35.2% vs 35.1%, respectively). Community cancer programs had the worst 5- and 10-year OS probabilities (41.1% and 21.8%, respectively).

The top 2 income quartiles combined to demonstrate the longest median, 5-year, and 10-year OS probabilities and were very similar. Patients living in a zip code with the highest income level had the longest 5-year OS rates of 54.3%, while patients living in zip codes with a moderate income level had the longest 10-year OS at 39.3% and the longest median OS of about 71 months. Patients with the lowest level of median household income had the worst 5-year OS rates (48.3%) and a median (SD) OS of 53.4 (5.4) months (Figure 4).

A Kaplan-Meier curve for percentage of adults without a HS degree is displayed in Figure 5. Zip codes with the highest level of education had the longest 5-year OS rates and median (SD) OS of 55.3% and 70.9 (4.8) months, respectively. The longest 10-year OS outcomes at 38.1% were found in patients who lived in areas of low-education levels. The worst 5- and 10- year OS outcomes and median OS were found in the least educated zip codes.

Results from the Cox regression model of OS are displayed in Table 4. Race and ethnicity, zip code-level median household income, and zip code-level education were not associated with OS. Patients with no insurance had an increased risk of death (hazard ratio [HR], 1.84; 95% CI, 1.17-2.88; P < .01) when compared with patients with private insurance. Patients with other government insurance also had an increased risk of death (HR, 2.12; 95% CI, 1.27-3.54; P < .01) when compared with patients with private insurance while controlling for all other variables. Patients with Medicare had a decreased risk of death when compared with patients with other government insurance and no insurance (HR, 0.53; 95% CI, 0.31-0.92; P = .02 and HR, 0.62; 95% CI, 0.38-0.99; P = .05, respectively). Patients treated at academic centers had better OS when compared with patients treated at comprehensive treatment centers (HR, 0.77; 95% CI, 0.65-0.92;P < .01) and community treatment centers (HR, 0.62; 95% CI, 0.44-0.86; P < .01).

Discussion

This study is the largest study to date that specifically studies the type of treatment facilities and socioeconomic factors, including insurance status, race, income, and education, and how they affect survival of DDLPS. The overall 5- and 10-year OS probabilities for DDLPS in this study were 51.5% and 34.8%, respectively, with median OS of 63.6 months. These results were more encouraging than previous reports, which found a 5-year survival probability of 36.5% and a median OS of 45 months.^13,14

The largest age grouping was aged 61 to 80 years (48.9% of the cohort), and the median age at diagnosis was 64 years. DDLPSs most typically present between the ages of 50 and 70 years.¹⁵ Our cohort was 65% male. Previous studies have indicated that DDLPSs affect the sexes equally; however, another study showed a similar male predominance (68.8%) at the MD Anderson Cancer Center in Houston, Texas.^13,16

In our study, approximately 88% of patients were white, 6.5% were African American, and 2.5% were Asian, which differed from a previous study of 84 patients that had a 78.6% white, 4.8% Asian, and 1.2% African American patient population.¹⁴

Asian Indian or Pakistani patients had the best 5-year OS probability at 77.9%, followed by African American (57.2%), Asian (51.6%), AI/AN (51.4%), and white patients (50.9%). This trend had disappeared by 10 years and Asian, AI/AN, African American, and Asian Indian or Pakistani groups all demonstrated longer median OS than did white patients. In fact, Asian patients had the longest median OS at 119.8 months, which was almost double that of white patients with the lowest median OS of 61.2 months. This finding is contrary to previous studies, which reported that racial minorities typically had worse OS outcomes when compared with white patients in different types of cancer.^7,17 Notably, these findings were not statistically significant in our current study in the log-rank or multivariable analyses.

Private insurance was the most common form of insurance followed in decreasing order by Medicare, Medicaid, uninsured, and other government insurance. About 42% of the cohort had Medicare, which is a federally funded US insurance program designated for patients aged ≥ 65 years and certain younger patients with disabilities.

Patients with private insurance demonstrated the longest OS, essentially twice the median OS of all other insured groups at 101 months. Medicare had the worst 5-year OS probability and median OS of all groups. A previous study of 77 patients with DDLPS reported that patients aged > 65 years had reduced OS.13 Medicare patients in this study were older, with a mean and median age at DDLPS diagnosis of 71 and 72 years, respectively, while private insurance had a mean and median age at diagnosis of 56 and 57 years, respectively. Medicare inherently covers older patients and this age difference could account for the decrease in overall survival.

Improved OS for privately insured patients was most notable compared with the uninsured or patients with other government insurance. Uninsured patients had an 83.7% increased risk of mortality when compared with patients with private insurance. When compared with patients with private insurance, patients with other government insurance had an 111.5% increased risk of mortality. Comparing patients with Medicare vs patients with no insurance or other government insurance, there was a decreased risk of mortality of 38.5% and 46.6%, respectively. This decreased OS in patients with other government insurance could be related to the choice of treatment facility, because only 31% of the patients with other government insurance went to academic or research centers when compared with the 58.4% and 50.8% of patients with private and Medicare insurance treated there (data not shown). Such centers often have access to more advanced technology and protocols that may not be available at other treatment facilities.

A little more than half of the patients in the cohort went to an academic or research center for treatment (53.7%); comprehensive community cancer programs were the second most common treatment facility at 28%. Patients treated at academic or research centers demonstrated the best outcomes with a 5-year OS of 52.6%, followed in decreasing order by comprehensive community cancer programs (49.7%), integrated network cancer programs (48.8%), and community cancer programs (41.1%). In our patient cocohort, patients treated at an academic/research center had slightly decreased 10-year OS rates compared with those patients treated at a comprehensive community cancer program, although the median OS for the academic/research centers were still the highest of all treatment facilities.

Treatment options varied significantly by facility, and the number of patients treated surgically followed a similar trend, with 92% undergoing surgery as the primary treatment at academic or research programs compared with 89% at comprehensive cancer programs and 82.7% at community cancer programs (data not shown). Another potential explaination for differing OS outcomes across facilities is the surgical margin outcome. Surgeries performed at community cancer programs or comprehensive cancer programs resulted with no residual tumor in 36% and 40% of cases, respectively, whereas cases performed at academic or research programs resulted with no residual tumor in 47% of cases (data not shown). Regardless, multivariate analysis demonstrated a marked decrease in the chance of mortality when comparing treatment received at academic facility centers with that received at comprehensive cancer centers (22.9%) and community cancer centers (38.3%) (data not shown).

A recent study demonstrated improved outcomes for patients with retroperitoneal or extremity STS treated at high-volume treatment centers.¹⁸ Patients treated at high-volume centers were found to have an 8% decreased risk of death compared with patients treated at low-volume centers. Notably, they found highvolume academic centers demonstrated the strongest improvement in survival, while highvolume community centers showed decreased survival.¹⁸ Similarly, we found that patients treated at academic/research institutions had improved 5-year OS and greater median OS than did patients treated at community cancer programs or comprehensive community cancer programs.

The top 2 income quartiles (≥ $48,000) combined to demonstrate the longest median, 5-year, and 10-year OS and were fairly similar between the quartiles. Patients living in zip codes with a median income of $38,000 to $47,999 had the worst 5-year OS and median OS. The log-rank analysis showed statistical evidence of differences in survival associated with income, but within the context of the multivariable analysis, there was no remaining evidence of a difference.

The longest 5-year OS outcomes were seen in patients living in zip codes with the highest level of education (55.3%). However, the difference in OS was not statistically significant using either the log-rank analysis or multivariate analysis.

Limitations

This study has certain inherent limitations in using a retrospective design and a large database such as the NCDB. Many different pathologists at CoC-accredited cancer programs perform the pathology that contributes to the data in the NCDB. There was no pathological review of these findings, which could potentially introduce error into the findings of this study. With the NCDB, potential selection bias is possible because patients in the database are added only from CoC-accredited cancer programs. This risk is minimized because NCDB contains data on most newly diagnosed cancer patients in the US. Further potential risks, which are unable to be controlled for, include potential interobserver error and data that may be incompletely, improperly, or inaccurately recorded from the patients’ charts. Without patient-specific information regarding income and education, it is challenging to utilize zip codes to estimate socioeconomic status and educational level. Even though a patient may live in a zip code identified with specific economic and educational characteristics, that patient may not share those characteristics. Furthermore, patients with Medicare tend to be older than patients with other forms of insurance, which limits the significance of comparisons across insurance groups. A future SEER (Surveillance, Epidemiology, and End Results) program study to confirm this study’s results and the effects of socioeconomic variables on DDLPS would be an excellent followup study.

Conclusion

This study used a large cohort of patients with DDLPS to study the effects of treatment facility, insurance status, and socioeconomic variables on survival outcomes. Although insurance status, median household income, and treatment facility were associated with differences in median OS and 5- and 10-year OS probabilities, evidence for a difference remained for only insurance status and facility type within the context of a multivariable analysis irrespective of age, race, sex, insurance status, education, and median income. Patients with private insurance and Medicaid had a decreased risk of mortality compared with other government insurance and no insurance. Patients receiving treatment at academic research programs had the highest median and 5-year OS of 66.6 months and 52.6%, respectively. Patients receiving treatment at academic centers had improved survival outcomes with a decrease in mortality of 23% and 38% compared to comprehensive or community cancer programs.

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OSPHENA HAS NEW INDICATION

FOR MORE INFORMATION, VISIT: https://www.osphena.com/.

NEW 3-IN-1 HYSTEROSCOPE

FOR MORE INFORMATION, VISIT: https://gynsurgicalsolutions.com/product/omni-hysteroscope/.

SURGICAL RF TECHNOLOGY

FOR MORE INFORMATION, VISIT: https://www.cynosure.com/tempsure-platform. 

PROFESSIONAL FOOT SUPPORTS

FOR MORE INFORMATION, VISIT: https://www.comenitymed.com.

OSPHENA HAS NEW INDICATION

FOR MORE INFORMATION, VISIT: https://www.osphena.com/.

NEW 3-IN-1 HYSTEROSCOPE

FOR MORE INFORMATION, VISIT: https://gynsurgicalsolutions.com/product/omni-hysteroscope/.

SURGICAL RF TECHNOLOGY

FOR MORE INFORMATION, VISIT: https://www.cynosure.com/tempsure-platform. 

PROFESSIONAL FOOT SUPPORTS

FOR MORE INFORMATION, VISIT: https://www.comenitymed.com.

Cancer and cancer-related treatment can cause a myriad of adverse effects.^1,2 Early identification and management of these symptoms is paramount to the success of cancer treatment completion; however, clinic and telephonic strategies for addressing symptoms often result in delays in care.¹ New strategies for patient engagement in the management of cancer and treatment-related symptoms are needed.

The use of online self-management tools can result in improvement in symptoms, reduce cancer symptom distress, improve quality-of-life, and improve medication adherence.^3-9 A meta-analysis concluded that online interventions showed promise, but optimizing interventions would require additional research.¹⁰ Another meta-analysis found that online self-management was effective in managing several symptoms.¹¹ An e-health method of collecting patient self-reported symptoms has been found to be acceptable to patients and feasible for use.^12-14 We postulated that a mobile text messaging strategy may be an effective modality for augmenting symptom management for cancer patients in real time.

In the US Departmant of Veterans Affairs (VA), “Annie,” a self-care tool utilizing a text-messaging system has been implemented. Annie was developed modeling “Flo,” a messaging system in the United Kingdom that has been used for case management of chronic obstructive pulmonary disease, heart failure, stress incontinence, asthma, as a medication reminder tool, and to provide support for weight loss or post-operatively.^15-17 Using Annie in the US, veterans have the ability to receive and track health information. Use of the Annie program has demonstrated improved continuous positive airway pressure monitor utilization in veterans with traumatic brain injury.¹⁸ Other uses within the Veterans Health Administration (VHA) include assisting patients with anger management, liver disease, anxiety, asthma, diabetes, HIV, hypertension, weight loss, and smoking cessation.

Methods

The Hematology/Oncology division of the Minneapolis VA Healthcare System (MVAHCS) is a tertiary care facility that administers about 260 new chemotherapy regimens annually. The MVAHCS interdisciplinary hematology/oncology group initiated a quality improvement project to determine the feasibility, acceptability, and experience of tailoring the Annie tool for self-management of cancer symptoms. The group consisted of 2 physicians, 3 advanced practice registered nurses, 1 physician assistant, 2 registered nurses, and 2 Annie program team members.

We first created a symptom management pilot protocol as a result of multidisciplinary team discussions. Examples of discussion points for consideration included, but were not limited to, timing of texts, amount of information to ask for and provide, what potential symptoms to consider, and which patient population to pilot first.

Results

Through screening new patient consults or those referred for chemotherapy education, 15 male veterans enrolled in the symptom monitoring program over an 8 month period. There were additional patients who were not offered the program or chose not to participate; often due to not having texting capabilities on their phone or not liking the texting feature. The majority of those who participated in the program (n = 14) were enrolled at the start of Cycle 1; the other patient was enrolled at the start of Cycle 2. Patients were enrolled an average of 89 days (range 8-204). Average response rate was 84.2% (range 30-100%).

Although symptoms were not reviewed in real time, we reviewed responses to determine the utilization of the instructions given for the program. No veteran had 0 symptoms reported. There were numerous occurrences of a score of 1 or 2. Many of these patients had baseline symptoms due to their underlying cancer. A score of 3 or 4 on the system prompted the patient to call the clinic or go to the ED. Seven patients (some with multiple occurrences) were prompted to call; only 4 of these made the follow-up call to the clinic. All were offered a same day visit, but each declined. Only 1 patient reported a symptom on a day not prompted for that symptom. Symptoms that were reported are listed in order of frequency: fatigue, appetite loss, numbness, pain, mouth sore, and breathing difficulty. There were no visits to the ED.

Program Evaluation

An evaluation was conducted 30 to 60 days after program enrollment. We elicited feedback to determine who was reading and responding to the text message: the patient, a family member, or a caregiver; whether they found the prompts helpful and took action; how they felt about the number of texts; if they felt the program was helpful; and any other feedback that would improve the program. In general, the patients (8) answered the texts independently. In 4 cases, the spouse answered the texts, and 3 patients answered the texts together with their spouses. Most patients (11) found the amount of texting to be “just right.” However, 3 found it to be too many texts and 1 didn’t find the amount of texting to be enough.

Three veterans did not have enough symptoms to feel the program was of benefit to them, but they did feel it would have been helpful if they had been more symptomatic. One veteran recalled taking loperamide as needed, as a result of prompting. No veterans felt as though the texting feature was difficult to use; and overall, were very positive about the program. Several appreciated receiving messages that validated when they were doing well, and they felt empowered by self-management. One of the spouses was a registered nurse and found the information too basic to be of use.

Discussion

Initial evaluation of the program via survey found no technology challenges. Patients have been very positive about the program including ease of use, appreciation of messages that validated when they were doing well, empowerment of self-management, and some utilization of the texting advice for symptom management. Educational hyperlinks for constipation, fatigue, diarrhea, and nausea/vomiting were added after this evaluation, and patients felt that these additions provided a higher level of education.

Staff time for this intervention was minimal. A nurse navigator offered the texting program to the patient during chemotherapy education, along with some instructions, which generally took about 5 minutes. One of the Annie program staff enrolled the patient. From that point forward, this was a self-management tool, beyond checking to ensure that the patient was successful in starting the program and evaluating use for the purposes of this quality improvement project. This self-management tool did not replace any other mechanism that a patient would normally have in our department for seeking help for symptoms. The MVAHSC typical process for symptom management is to have patients call a 24/7 nurse line. If the triage nurse feels the symptoms are related to the patient’s cancer or cancer treatment, they are referred to the physician assistant who is assigned to take those calls and has the option to see the patient the same day. Patients could continue to call the nurse line or speak with providers at the next appointment at their discretion.

Conclusion

Although Annie has the option of using either text messaging or a mobile application, this project only utilized text messaging. The study by Basch and colleagues was the closest randomized trial we could identify to compare to our quality improvement intervention.⁵ The 2 main, distinct differences were that Basch and colleagues utilized online monitoring; and nurses were utilized to screen and intervene on responses, as appropriate.

The ability of our program to text patients without the use of an application or tablet, may enable more patients to participate due to ease of use. There would be no increased in expected workload for clinical staff, and may lead to decreased call burden. Since our program is automated, while still providing patients with the option to call and speak with a staff member as needed, this is a cost-effective, first-line option for symptom management for those experiencing cancer-related symptoms. We believe this text messaging tool can have system wide use and benefit throughout the VHA.

Cancer and cancer-related treatment can cause a myriad of adverse effects.^1,2 Early identification and management of these symptoms is paramount to the success of cancer treatment completion; however, clinic and telephonic strategies for addressing symptoms often result in delays in care.¹ New strategies for patient engagement in the management of cancer and treatment-related symptoms are needed.

The use of online self-management tools can result in improvement in symptoms, reduce cancer symptom distress, improve quality-of-life, and improve medication adherence.^3-9 A meta-analysis concluded that online interventions showed promise, but optimizing interventions would require additional research.¹⁰ Another meta-analysis found that online self-management was effective in managing several symptoms.¹¹ An e-health method of collecting patient self-reported symptoms has been found to be acceptable to patients and feasible for use.^12-14 We postulated that a mobile text messaging strategy may be an effective modality for augmenting symptom management for cancer patients in real time.

In the US Departmant of Veterans Affairs (VA), “Annie,” a self-care tool utilizing a text-messaging system has been implemented. Annie was developed modeling “Flo,” a messaging system in the United Kingdom that has been used for case management of chronic obstructive pulmonary disease, heart failure, stress incontinence, asthma, as a medication reminder tool, and to provide support for weight loss or post-operatively.^15-17 Using Annie in the US, veterans have the ability to receive and track health information. Use of the Annie program has demonstrated improved continuous positive airway pressure monitor utilization in veterans with traumatic brain injury.¹⁸ Other uses within the Veterans Health Administration (VHA) include assisting patients with anger management, liver disease, anxiety, asthma, diabetes, HIV, hypertension, weight loss, and smoking cessation.

Methods

The Hematology/Oncology division of the Minneapolis VA Healthcare System (MVAHCS) is a tertiary care facility that administers about 260 new chemotherapy regimens annually. The MVAHCS interdisciplinary hematology/oncology group initiated a quality improvement project to determine the feasibility, acceptability, and experience of tailoring the Annie tool for self-management of cancer symptoms. The group consisted of 2 physicians, 3 advanced practice registered nurses, 1 physician assistant, 2 registered nurses, and 2 Annie program team members.

We first created a symptom management pilot protocol as a result of multidisciplinary team discussions. Examples of discussion points for consideration included, but were not limited to, timing of texts, amount of information to ask for and provide, what potential symptoms to consider, and which patient population to pilot first.

Results

Through screening new patient consults or those referred for chemotherapy education, 15 male veterans enrolled in the symptom monitoring program over an 8 month period. There were additional patients who were not offered the program or chose not to participate; often due to not having texting capabilities on their phone or not liking the texting feature. The majority of those who participated in the program (n = 14) were enrolled at the start of Cycle 1; the other patient was enrolled at the start of Cycle 2. Patients were enrolled an average of 89 days (range 8-204). Average response rate was 84.2% (range 30-100%).

Although symptoms were not reviewed in real time, we reviewed responses to determine the utilization of the instructions given for the program. No veteran had 0 symptoms reported. There were numerous occurrences of a score of 1 or 2. Many of these patients had baseline symptoms due to their underlying cancer. A score of 3 or 4 on the system prompted the patient to call the clinic or go to the ED. Seven patients (some with multiple occurrences) were prompted to call; only 4 of these made the follow-up call to the clinic. All were offered a same day visit, but each declined. Only 1 patient reported a symptom on a day not prompted for that symptom. Symptoms that were reported are listed in order of frequency: fatigue, appetite loss, numbness, pain, mouth sore, and breathing difficulty. There were no visits to the ED.

Program Evaluation

An evaluation was conducted 30 to 60 days after program enrollment. We elicited feedback to determine who was reading and responding to the text message: the patient, a family member, or a caregiver; whether they found the prompts helpful and took action; how they felt about the number of texts; if they felt the program was helpful; and any other feedback that would improve the program. In general, the patients (8) answered the texts independently. In 4 cases, the spouse answered the texts, and 3 patients answered the texts together with their spouses. Most patients (11) found the amount of texting to be “just right.” However, 3 found it to be too many texts and 1 didn’t find the amount of texting to be enough.

Three veterans did not have enough symptoms to feel the program was of benefit to them, but they did feel it would have been helpful if they had been more symptomatic. One veteran recalled taking loperamide as needed, as a result of prompting. No veterans felt as though the texting feature was difficult to use; and overall, were very positive about the program. Several appreciated receiving messages that validated when they were doing well, and they felt empowered by self-management. One of the spouses was a registered nurse and found the information too basic to be of use.

Discussion

Initial evaluation of the program via survey found no technology challenges. Patients have been very positive about the program including ease of use, appreciation of messages that validated when they were doing well, empowerment of self-management, and some utilization of the texting advice for symptom management. Educational hyperlinks for constipation, fatigue, diarrhea, and nausea/vomiting were added after this evaluation, and patients felt that these additions provided a higher level of education.

Staff time for this intervention was minimal. A nurse navigator offered the texting program to the patient during chemotherapy education, along with some instructions, which generally took about 5 minutes. One of the Annie program staff enrolled the patient. From that point forward, this was a self-management tool, beyond checking to ensure that the patient was successful in starting the program and evaluating use for the purposes of this quality improvement project. This self-management tool did not replace any other mechanism that a patient would normally have in our department for seeking help for symptoms. The MVAHSC typical process for symptom management is to have patients call a 24/7 nurse line. If the triage nurse feels the symptoms are related to the patient’s cancer or cancer treatment, they are referred to the physician assistant who is assigned to take those calls and has the option to see the patient the same day. Patients could continue to call the nurse line or speak with providers at the next appointment at their discretion.

Conclusion

Although Annie has the option of using either text messaging or a mobile application, this project only utilized text messaging. The study by Basch and colleagues was the closest randomized trial we could identify to compare to our quality improvement intervention.⁵ The 2 main, distinct differences were that Basch and colleagues utilized online monitoring; and nurses were utilized to screen and intervene on responses, as appropriate.

The ability of our program to text patients without the use of an application or tablet, may enable more patients to participate due to ease of use. There would be no increased in expected workload for clinical staff, and may lead to decreased call burden. Since our program is automated, while still providing patients with the option to call and speak with a staff member as needed, this is a cost-effective, first-line option for symptom management for those experiencing cancer-related symptoms. We believe this text messaging tool can have system wide use and benefit throughout the VHA.

Cancer and cancer-related treatment can cause a myriad of adverse effects.^1,2 Early identification and management of these symptoms is paramount to the success of cancer treatment completion; however, clinic and telephonic strategies for addressing symptoms often result in delays in care.¹ New strategies for patient engagement in the management of cancer and treatment-related symptoms are needed.

The use of online self-management tools can result in improvement in symptoms, reduce cancer symptom distress, improve quality-of-life, and improve medication adherence.^3-9 A meta-analysis concluded that online interventions showed promise, but optimizing interventions would require additional research.¹⁰ Another meta-analysis found that online self-management was effective in managing several symptoms.¹¹ An e-health method of collecting patient self-reported symptoms has been found to be acceptable to patients and feasible for use.^12-14 We postulated that a mobile text messaging strategy may be an effective modality for augmenting symptom management for cancer patients in real time.

In the US Departmant of Veterans Affairs (VA), “Annie,” a self-care tool utilizing a text-messaging system has been implemented. Annie was developed modeling “Flo,” a messaging system in the United Kingdom that has been used for case management of chronic obstructive pulmonary disease, heart failure, stress incontinence, asthma, as a medication reminder tool, and to provide support for weight loss or post-operatively.^15-17 Using Annie in the US, veterans have the ability to receive and track health information. Use of the Annie program has demonstrated improved continuous positive airway pressure monitor utilization in veterans with traumatic brain injury.¹⁸ Other uses within the Veterans Health Administration (VHA) include assisting patients with anger management, liver disease, anxiety, asthma, diabetes, HIV, hypertension, weight loss, and smoking cessation.

Methods

The Hematology/Oncology division of the Minneapolis VA Healthcare System (MVAHCS) is a tertiary care facility that administers about 260 new chemotherapy regimens annually. The MVAHCS interdisciplinary hematology/oncology group initiated a quality improvement project to determine the feasibility, acceptability, and experience of tailoring the Annie tool for self-management of cancer symptoms. The group consisted of 2 physicians, 3 advanced practice registered nurses, 1 physician assistant, 2 registered nurses, and 2 Annie program team members.

We first created a symptom management pilot protocol as a result of multidisciplinary team discussions. Examples of discussion points for consideration included, but were not limited to, timing of texts, amount of information to ask for and provide, what potential symptoms to consider, and which patient population to pilot first.

Results

Through screening new patient consults or those referred for chemotherapy education, 15 male veterans enrolled in the symptom monitoring program over an 8 month period. There were additional patients who were not offered the program or chose not to participate; often due to not having texting capabilities on their phone or not liking the texting feature. The majority of those who participated in the program (n = 14) were enrolled at the start of Cycle 1; the other patient was enrolled at the start of Cycle 2. Patients were enrolled an average of 89 days (range 8-204). Average response rate was 84.2% (range 30-100%).

Although symptoms were not reviewed in real time, we reviewed responses to determine the utilization of the instructions given for the program. No veteran had 0 symptoms reported. There were numerous occurrences of a score of 1 or 2. Many of these patients had baseline symptoms due to their underlying cancer. A score of 3 or 4 on the system prompted the patient to call the clinic or go to the ED. Seven patients (some with multiple occurrences) were prompted to call; only 4 of these made the follow-up call to the clinic. All were offered a same day visit, but each declined. Only 1 patient reported a symptom on a day not prompted for that symptom. Symptoms that were reported are listed in order of frequency: fatigue, appetite loss, numbness, pain, mouth sore, and breathing difficulty. There were no visits to the ED.

Program Evaluation

An evaluation was conducted 30 to 60 days after program enrollment. We elicited feedback to determine who was reading and responding to the text message: the patient, a family member, or a caregiver; whether they found the prompts helpful and took action; how they felt about the number of texts; if they felt the program was helpful; and any other feedback that would improve the program. In general, the patients (8) answered the texts independently. In 4 cases, the spouse answered the texts, and 3 patients answered the texts together with their spouses. Most patients (11) found the amount of texting to be “just right.” However, 3 found it to be too many texts and 1 didn’t find the amount of texting to be enough.

Three veterans did not have enough symptoms to feel the program was of benefit to them, but they did feel it would have been helpful if they had been more symptomatic. One veteran recalled taking loperamide as needed, as a result of prompting. No veterans felt as though the texting feature was difficult to use; and overall, were very positive about the program. Several appreciated receiving messages that validated when they were doing well, and they felt empowered by self-management. One of the spouses was a registered nurse and found the information too basic to be of use.

Discussion

Initial evaluation of the program via survey found no technology challenges. Patients have been very positive about the program including ease of use, appreciation of messages that validated when they were doing well, empowerment of self-management, and some utilization of the texting advice for symptom management. Educational hyperlinks for constipation, fatigue, diarrhea, and nausea/vomiting were added after this evaluation, and patients felt that these additions provided a higher level of education.

Staff time for this intervention was minimal. A nurse navigator offered the texting program to the patient during chemotherapy education, along with some instructions, which generally took about 5 minutes. One of the Annie program staff enrolled the patient. From that point forward, this was a self-management tool, beyond checking to ensure that the patient was successful in starting the program and evaluating use for the purposes of this quality improvement project. This self-management tool did not replace any other mechanism that a patient would normally have in our department for seeking help for symptoms. The MVAHSC typical process for symptom management is to have patients call a 24/7 nurse line. If the triage nurse feels the symptoms are related to the patient’s cancer or cancer treatment, they are referred to the physician assistant who is assigned to take those calls and has the option to see the patient the same day. Patients could continue to call the nurse line or speak with providers at the next appointment at their discretion.

Conclusion

Although Annie has the option of using either text messaging or a mobile application, this project only utilized text messaging. The study by Basch and colleagues was the closest randomized trial we could identify to compare to our quality improvement intervention.⁵ The 2 main, distinct differences were that Basch and colleagues utilized online monitoring; and nurses were utilized to screen and intervene on responses, as appropriate.

The ability of our program to text patients without the use of an application or tablet, may enable more patients to participate due to ease of use. There would be no increased in expected workload for clinical staff, and may lead to decreased call burden. Since our program is automated, while still providing patients with the option to call and speak with a staff member as needed, this is a cost-effective, first-line option for symptom management for those experiencing cancer-related symptoms. We believe this text messaging tool can have system wide use and benefit throughout the VHA.

Whoever seeks to set one religion against another seeks to destroy all religion.¹
President Franklin D. Roosevelt

Recently, a US Department of Veterans Affairs (VA) colleague knowing of my background in religious studies asked me what I thought of the recent change in VA religious policy. VA Secretary Robert Wilke had announced on July 3 that VA was revising its policies on religious symbols at all VA facilities and religious and pastoral care in the Veterans Health Administration, respectively.^2,3 A news release from the VA Office of Public and Intergovernmental Affairs designated the changes as an “overhaul.”⁴

The revisions in these VA directives are designed to address confusion and inconsistency regarding displays of religious matters, not just between different VA medical centers (VAMCs) but even within a single facility. From my decades as a federal practitioner and ethicist, I can attest to the confusion. I have heard or read from staff and leaders of VAMCs everything from “VA prohibits all religious symbols so take that Christmas tree down” to “it is fine to host holiday parties complete with decorations.” There certainly was a need for clarity, transparency, and fairness in VA policy regarding religious and spiritual symbolism. This editorial will discuss how, why, and whether the policy accomplishes this organizational ethics purpose.

The new policies have 3 aims: (1) to permit VA facilities to publicly display religious content in appropriate circumstances; (2) to allow patients and their guests to request and receive religious literature, sacred texts, and spiritual symbols during visits to VA chapels or episodes of treatment; and (3) to permit VA facilities to receive and dispense donations of religious literature, cards, and symbols to VA patrons under appropriate circumstances or when they ask for them.

Secretary Wilke announced the aim of the revised directives: “These important changes will bring simplicity and clarity to our policies governing religious and spiritual symbols, helping ensure we are consistently complying with the First Amendment to the US Constitution at thousands of facilities across the department.”⁴ As with most US Department of Defense (DoD) and VA decisions about potentially controversial issues, this one has a backstory involving 2 high-profile court cases that provide a deeper understanding of the subtext of the policy change.

In February 2019, the US Supreme Court heard oral arguments for The American Legion v American Humanist Association, the most recent of a long line of important cases about the First Amendment and its freedom of religion guarantee.⁵ This case involved veterans—although not the VA or DoD—and is of prima facie interest for those invested or interested in the VA’s position on religion. A 40-foot cross had stood in a veteran memorial park in Bladensburg, Maryland, for decades. In the 1960s the park became the property of the Maryland National Capital Park and Planning Commission (MNCPPC), which assumed the responsibility for upkeep for the cross at considerable expense. The American Humanist Association, an organization advocating for church-state separation, sued the MNCPPC on the grounds it violated the establishment clause of the First Amendment by promoting Christianity as a federally supported religion.

The US District Court found in favor of MNCPPC, but an appeals court reversed that decision. The American Legion, a major force in VA politics, joined MNCPPC to appeal the case to the Supreme Court. The Court issued a 7 to 2 decision, which ruled that the cross did not violate the establishment clause. Even though the cross began as religious symbol, with the passage of time the High Court opined that the cross had become a historic memorial honoring those who fought in the First World War, which rose above its purely Christian meaning.⁵

The American Legion website explicitly credited their success before the Supreme Court as the impetus for VA policy changes.⁶ Hence, from the perspective of VA leadership, this wider latitude for religious expression, which the revised policy now allows, renderings VA practice consonant with the authoritative interpreters of constitutional law—the highest court in the land.

Of course, on a question that has been so divisive for the nation since its founding, there are many who protest this extension of religious liberty in the federal health care system. Veterans stand tall on both sides of this divide. In May 2019 a US Air Force veteran filed a federal lawsuit against the Manchester VAMC director asking the court to remove a Christian Bible from a public display.⁷ With echoes of the Maryland cross case, the Bible in question was owned by a World War II prisoner of war (POW) and sat on a missing man remembrance table for all POWs in the lobby of the facility. Following complaints, the Bible was initially removed but was then returned after complaints over the removal.

Air Force Times compared the resulting melee to actual combat!⁷ As with the first case, such legal battles are ripe territory for advocacy and lobbying organizations of all political stripes to weigh in while promoting their own ideologic agendas. The Military Religious Freedom Foundation assumed the mantle on behalf of the Air Force veteran in the Manchester suit. The news media reported that the plaintiff in the case identified himself as a committed Christian. According to the news reports, what worried this veteran was the same thing that troubled President Roosevelt in 1940: By featuring the Christian Bible, the VA excluded other faith groups.¹ Other veterans and some veteran religious organizations objected just as strenuously to its removal, likely done to reduce potential for violence. Veterans opposing the inclusion of the Bible in the display also grounded their arguments in the First Amendment clause that prohibits the federal government from establishing or favoring any religion.⁸

Presumptively, displays of such religious symbols may well be supported in VA policy as a protected expression of religion, which Secretary Wilke stated was the other primary aim of the revisions. “We want to make sure that all of our veterans and their families feel welcome at VA, no matter their religious beliefs. Protecting religious liberty is a key part of how we accomplish that goal.”⁴

In the middle of this sensitive controversy are the many veterans and their families that third parties—for profit, for politics, for publicity—have far too often manipulated for their own purposes. If you want to get an idea of the scope of these diverse stakeholders, just peruse the amicus briefs submitted to the Supreme Court on both sides of the issues in The American Legion v American Humanist Association.⁸

VA data show that veterans while being more religious than the general public are religiously diverse: 2015 data on the religion of veterans in every state listed 13 different faith communities.⁹ My response to the colleague who asked me about my opinion of the VA policies changes was based on the background narrative recounted here. My rsponse, in light of Roosevelt’s concern and this snippet of a much larger swath of legal machinations, is the change in the VA policy is reasonable as long as it “has room for the expression of those whose trust is in God, in country, in neither, and in both.” We know from research that religion is a strength and a support to many veterans and that spirituality as an aspect of psychological therapies and pastoral counseling has shown healing power for the wounds of war.¹⁰ Yet we also know that religiously based hatred and discrimination are among the most divisive and destructive forces that threaten our democracy. Let’s all hope—and those who pray do so—that these policy changes deter the latter and promote the former.

Whoever seeks to set one religion against another seeks to destroy all religion.¹
President Franklin D. Roosevelt

Recently, a US Department of Veterans Affairs (VA) colleague knowing of my background in religious studies asked me what I thought of the recent change in VA religious policy. VA Secretary Robert Wilke had announced on July 3 that VA was revising its policies on religious symbols at all VA facilities and religious and pastoral care in the Veterans Health Administration, respectively.^2,3 A news release from the VA Office of Public and Intergovernmental Affairs designated the changes as an “overhaul.”⁴

The revisions in these VA directives are designed to address confusion and inconsistency regarding displays of religious matters, not just between different VA medical centers (VAMCs) but even within a single facility. From my decades as a federal practitioner and ethicist, I can attest to the confusion. I have heard or read from staff and leaders of VAMCs everything from “VA prohibits all religious symbols so take that Christmas tree down” to “it is fine to host holiday parties complete with decorations.” There certainly was a need for clarity, transparency, and fairness in VA policy regarding religious and spiritual symbolism. This editorial will discuss how, why, and whether the policy accomplishes this organizational ethics purpose.

The new policies have 3 aims: (1) to permit VA facilities to publicly display religious content in appropriate circumstances; (2) to allow patients and their guests to request and receive religious literature, sacred texts, and spiritual symbols during visits to VA chapels or episodes of treatment; and (3) to permit VA facilities to receive and dispense donations of religious literature, cards, and symbols to VA patrons under appropriate circumstances or when they ask for them.

Secretary Wilke announced the aim of the revised directives: “These important changes will bring simplicity and clarity to our policies governing religious and spiritual symbols, helping ensure we are consistently complying with the First Amendment to the US Constitution at thousands of facilities across the department.”⁴ As with most US Department of Defense (DoD) and VA decisions about potentially controversial issues, this one has a backstory involving 2 high-profile court cases that provide a deeper understanding of the subtext of the policy change.

In February 2019, the US Supreme Court heard oral arguments for The American Legion v American Humanist Association, the most recent of a long line of important cases about the First Amendment and its freedom of religion guarantee.⁵ This case involved veterans—although not the VA or DoD—and is of prima facie interest for those invested or interested in the VA’s position on religion. A 40-foot cross had stood in a veteran memorial park in Bladensburg, Maryland, for decades. In the 1960s the park became the property of the Maryland National Capital Park and Planning Commission (MNCPPC), which assumed the responsibility for upkeep for the cross at considerable expense. The American Humanist Association, an organization advocating for church-state separation, sued the MNCPPC on the grounds it violated the establishment clause of the First Amendment by promoting Christianity as a federally supported religion.

The US District Court found in favor of MNCPPC, but an appeals court reversed that decision. The American Legion, a major force in VA politics, joined MNCPPC to appeal the case to the Supreme Court. The Court issued a 7 to 2 decision, which ruled that the cross did not violate the establishment clause. Even though the cross began as religious symbol, with the passage of time the High Court opined that the cross had become a historic memorial honoring those who fought in the First World War, which rose above its purely Christian meaning.⁵

The American Legion website explicitly credited their success before the Supreme Court as the impetus for VA policy changes.⁶ Hence, from the perspective of VA leadership, this wider latitude for religious expression, which the revised policy now allows, renderings VA practice consonant with the authoritative interpreters of constitutional law—the highest court in the land.

Of course, on a question that has been so divisive for the nation since its founding, there are many who protest this extension of religious liberty in the federal health care system. Veterans stand tall on both sides of this divide. In May 2019 a US Air Force veteran filed a federal lawsuit against the Manchester VAMC director asking the court to remove a Christian Bible from a public display.⁷ With echoes of the Maryland cross case, the Bible in question was owned by a World War II prisoner of war (POW) and sat on a missing man remembrance table for all POWs in the lobby of the facility. Following complaints, the Bible was initially removed but was then returned after complaints over the removal.

Air Force Times compared the resulting melee to actual combat!⁷ As with the first case, such legal battles are ripe territory for advocacy and lobbying organizations of all political stripes to weigh in while promoting their own ideologic agendas. The Military Religious Freedom Foundation assumed the mantle on behalf of the Air Force veteran in the Manchester suit. The news media reported that the plaintiff in the case identified himself as a committed Christian. According to the news reports, what worried this veteran was the same thing that troubled President Roosevelt in 1940: By featuring the Christian Bible, the VA excluded other faith groups.¹ Other veterans and some veteran religious organizations objected just as strenuously to its removal, likely done to reduce potential for violence. Veterans opposing the inclusion of the Bible in the display also grounded their arguments in the First Amendment clause that prohibits the federal government from establishing or favoring any religion.⁸

Presumptively, displays of such religious symbols may well be supported in VA policy as a protected expression of religion, which Secretary Wilke stated was the other primary aim of the revisions. “We want to make sure that all of our veterans and their families feel welcome at VA, no matter their religious beliefs. Protecting religious liberty is a key part of how we accomplish that goal.”⁴

In the middle of this sensitive controversy are the many veterans and their families that third parties—for profit, for politics, for publicity—have far too often manipulated for their own purposes. If you want to get an idea of the scope of these diverse stakeholders, just peruse the amicus briefs submitted to the Supreme Court on both sides of the issues in The American Legion v American Humanist Association.⁸

VA data show that veterans while being more religious than the general public are religiously diverse: 2015 data on the religion of veterans in every state listed 13 different faith communities.⁹ My response to the colleague who asked me about my opinion of the VA policies changes was based on the background narrative recounted here. My rsponse, in light of Roosevelt’s concern and this snippet of a much larger swath of legal machinations, is the change in the VA policy is reasonable as long as it “has room for the expression of those whose trust is in God, in country, in neither, and in both.” We know from research that religion is a strength and a support to many veterans and that spirituality as an aspect of psychological therapies and pastoral counseling has shown healing power for the wounds of war.¹⁰ Yet we also know that religiously based hatred and discrimination are among the most divisive and destructive forces that threaten our democracy. Let’s all hope—and those who pray do so—that these policy changes deter the latter and promote the former.

Whoever seeks to set one religion against another seeks to destroy all religion.¹
President Franklin D. Roosevelt

Recently, a US Department of Veterans Affairs (VA) colleague knowing of my background in religious studies asked me what I thought of the recent change in VA religious policy. VA Secretary Robert Wilke had announced on July 3 that VA was revising its policies on religious symbols at all VA facilities and religious and pastoral care in the Veterans Health Administration, respectively.^2,3 A news release from the VA Office of Public and Intergovernmental Affairs designated the changes as an “overhaul.”⁴

The revisions in these VA directives are designed to address confusion and inconsistency regarding displays of religious matters, not just between different VA medical centers (VAMCs) but even within a single facility. From my decades as a federal practitioner and ethicist, I can attest to the confusion. I have heard or read from staff and leaders of VAMCs everything from “VA prohibits all religious symbols so take that Christmas tree down” to “it is fine to host holiday parties complete with decorations.” There certainly was a need for clarity, transparency, and fairness in VA policy regarding religious and spiritual symbolism. This editorial will discuss how, why, and whether the policy accomplishes this organizational ethics purpose.

The new policies have 3 aims: (1) to permit VA facilities to publicly display religious content in appropriate circumstances; (2) to allow patients and their guests to request and receive religious literature, sacred texts, and spiritual symbols during visits to VA chapels or episodes of treatment; and (3) to permit VA facilities to receive and dispense donations of religious literature, cards, and symbols to VA patrons under appropriate circumstances or when they ask for them.

Secretary Wilke announced the aim of the revised directives: “These important changes will bring simplicity and clarity to our policies governing religious and spiritual symbols, helping ensure we are consistently complying with the First Amendment to the US Constitution at thousands of facilities across the department.”⁴ As with most US Department of Defense (DoD) and VA decisions about potentially controversial issues, this one has a backstory involving 2 high-profile court cases that provide a deeper understanding of the subtext of the policy change.

In February 2019, the US Supreme Court heard oral arguments for The American Legion v American Humanist Association, the most recent of a long line of important cases about the First Amendment and its freedom of religion guarantee.⁵ This case involved veterans—although not the VA or DoD—and is of prima facie interest for those invested or interested in the VA’s position on religion. A 40-foot cross had stood in a veteran memorial park in Bladensburg, Maryland, for decades. In the 1960s the park became the property of the Maryland National Capital Park and Planning Commission (MNCPPC), which assumed the responsibility for upkeep for the cross at considerable expense. The American Humanist Association, an organization advocating for church-state separation, sued the MNCPPC on the grounds it violated the establishment clause of the First Amendment by promoting Christianity as a federally supported religion.

The US District Court found in favor of MNCPPC, but an appeals court reversed that decision. The American Legion, a major force in VA politics, joined MNCPPC to appeal the case to the Supreme Court. The Court issued a 7 to 2 decision, which ruled that the cross did not violate the establishment clause. Even though the cross began as religious symbol, with the passage of time the High Court opined that the cross had become a historic memorial honoring those who fought in the First World War, which rose above its purely Christian meaning.⁵

The American Legion website explicitly credited their success before the Supreme Court as the impetus for VA policy changes.⁶ Hence, from the perspective of VA leadership, this wider latitude for religious expression, which the revised policy now allows, renderings VA practice consonant with the authoritative interpreters of constitutional law—the highest court in the land.

Of course, on a question that has been so divisive for the nation since its founding, there are many who protest this extension of religious liberty in the federal health care system. Veterans stand tall on both sides of this divide. In May 2019 a US Air Force veteran filed a federal lawsuit against the Manchester VAMC director asking the court to remove a Christian Bible from a public display.⁷ With echoes of the Maryland cross case, the Bible in question was owned by a World War II prisoner of war (POW) and sat on a missing man remembrance table for all POWs in the lobby of the facility. Following complaints, the Bible was initially removed but was then returned after complaints over the removal.

Air Force Times compared the resulting melee to actual combat!⁷ As with the first case, such legal battles are ripe territory for advocacy and lobbying organizations of all political stripes to weigh in while promoting their own ideologic agendas. The Military Religious Freedom Foundation assumed the mantle on behalf of the Air Force veteran in the Manchester suit. The news media reported that the plaintiff in the case identified himself as a committed Christian. According to the news reports, what worried this veteran was the same thing that troubled President Roosevelt in 1940: By featuring the Christian Bible, the VA excluded other faith groups.¹ Other veterans and some veteran religious organizations objected just as strenuously to its removal, likely done to reduce potential for violence. Veterans opposing the inclusion of the Bible in the display also grounded their arguments in the First Amendment clause that prohibits the federal government from establishing or favoring any religion.⁸

Presumptively, displays of such religious symbols may well be supported in VA policy as a protected expression of religion, which Secretary Wilke stated was the other primary aim of the revisions. “We want to make sure that all of our veterans and their families feel welcome at VA, no matter their religious beliefs. Protecting religious liberty is a key part of how we accomplish that goal.”⁴

In the middle of this sensitive controversy are the many veterans and their families that third parties—for profit, for politics, for publicity—have far too often manipulated for their own purposes. If you want to get an idea of the scope of these diverse stakeholders, just peruse the amicus briefs submitted to the Supreme Court on both sides of the issues in The American Legion v American Humanist Association.⁸

VA data show that veterans while being more religious than the general public are religiously diverse: 2015 data on the religion of veterans in every state listed 13 different faith communities.⁹ My response to the colleague who asked me about my opinion of the VA policies changes was based on the background narrative recounted here. My rsponse, in light of Roosevelt’s concern and this snippet of a much larger swath of legal machinations, is the change in the VA policy is reasonable as long as it “has room for the expression of those whose trust is in God, in country, in neither, and in both.” We know from research that religion is a strength and a support to many veterans and that spirituality as an aspect of psychological therapies and pastoral counseling has shown healing power for the wounds of war.¹⁰ Yet we also know that religiously based hatred and discrimination are among the most divisive and destructive forces that threaten our democracy. Let’s all hope—and those who pray do so—that these policy changes deter the latter and promote the former.

Nonadherence is a significant problem that has a negative impact on both patients and public health. Patients with multiple diseases often have complicated medication regimens, which can be difficult for them to manage. Unfortunately, nonadherence in these high-risk patients can have drastic consequences, including disease progression, hospitalization, and death, resulting in billions of dollars in unnecessary costs nationwide.^1,2 The Wheel Model of Pharmaceutical Care (Figure) is a novel care model developed at the Gallup Indian Medical Center (GIMC) in New Mexico to address these problems by positioning pharmacy as a proactive service. The Wheel Model of Pharmaceutical Care was designed to improve adherence and patient outcomes and to encourage communication among the patient, pharmacists, prescribers, and other health care team members.

Pharmacists are central to managing patients’ medication therapies and coordinating communication among the health care providers (HCPs).^1,3 Medication therapy management (MTM), a required component of Medicare Part D plans, helps ensure appropriate drug use and reduce the risk of adverse events.³ Since pharmacists receive prescriptions from all of the patient’s HCPs, patients may see pharmacists more often than they see any other HCP. GIMC is currently piloting a new clinic, the Medication Optimization, Synchronization, and Adherence Improvement Clinic (MOSAIC), that was created to implement the Wheel Model of Pharmaceutical Care. MOSAIC aims to provide proactive pharmacy services and continuous MTM to high-risk patients and will enable the effectiveness of this new pharmaceutical care model to be assessed.

Methods

Studies have identified certain populations who are at an increased risk for nonadherence: the elderly, patients with complex or extensive medication regimens, patients with multiple chronic medical conditions, substance misusers, certain ethnicities, patients of lower socioeconomic status, patients with limited literacy, and the homeless.^2,4 Federal regulations require that Medicare Part D plans target beneficiaries who meet specific criteria for MTM programs. Under these rules, plans must target beneficiaries with ≥ 3 chronic diseases and ≥ 8 chronic medications, although plans also may include patients with fewer medications and diseases.³ Although the Wheel Model of Pharmaceutical Care is postulated to be an accurate model for the ideal care of all patients, initial implementation should be targeted toward populations who are likely to benefit the most from intervention. For these reasons, elderly Native American patients who have ≥ 2 chronic diseases and who take ≥ 5 chronic medications were targeted for initial enrollment in MOSAIC at GIMC.

Overview

In MOSAIC, pharmacists act as the hub of the pharmaceutical care wheel. Pharmacists work to ensure optimization of the patient’s comprehensive, integrated care plan—the rim of the wheel. As a part of this optimization process, MOSAIC pharmacists facilitate synchronization of the patient’s prescriptions to a monthly or quarterly target fill date. The patient’s current medication therapy is organized, and pharmacists track which medications are due to be filled instead of depending on the patient to request each prescription refill. This process effectively changes pharmacy from a requested service to a provided service.

Pharmacists also monitor the air in the tire to promote adherence. This is accomplished by providing efficient monthly or quarterly telephone or in-person consultations, which helps the patient better understand his or her comprehensive, integrated care plan. MOSAIC eliminates the possibility of nonadherence due to running out of refills. Specialized packaging, such as pill boxes or blister packs, can also improve adherence for certain patients.

MOSAIC ensures that pharmacists stay connected with the spokes, which represent a patient’s numerous prescribers, and close communication loops. Pharmacists can make prescribers aware of potential gaps or overlaps in treatment and assist them in the optimization and development of the patient’s comprehensive, integrated care plan. Pharmacists also make sure that the patient’s medication profile is current and accurate in the electronic health record (EHR). Any pertinent information discovered during MOSAIC encounters, such as abnormal laboratory results or changes in medications or disease, is documented in an EHR note. The patient’s prescribers are made aware of this information by tagging them as additional signers to the note in the EHR.

Keeping patients—the tires—healthy will ensure smooth operation of the vehicle and have a positive impact on public health. MOSAIC is expected to not only improve individual patient outcomes, but also decrease health care costs for patients and society due to nonadherence, suboptimal regimens, stockpiled home medications, and preventable hospital admissions.

Traditionally, pharmacy has been a requested service: A patient requests each of their prescriptions to be refilled, and the pharmacy fills the prescription. Ideally, pharmacy must become a provided service, with pharmacists keeping track of when a patient’s medications are due to be filled and actively looking for medication therapy optimization opportunities. This is accomplished by synchronizing the patient’s medications to the same monthly or quarterly fill date; screening for any potentially inappropriate medications, including high-risk medications in elderly patients, duplications, and omissions; verifying any medication changes with the patient each fill; and then providing all needed medications to the patient at a scheduled time.

To facilitate this process, custom software was developed for MOSAIC. In addition, a collaborative practice agreement (CPA) was drafted that allowed MOSAIC pharmacists to make certain medication therapy optimizations on behalf of the patient’s primary care provider. As part of this CPA, pharmacists also may order and act on certain laboratory tests, which helps to monitor disease progression, ensure safe medication use, and meet Government Performance and Results Act (GPRA) measures. As a novel model of pharmaceutical care, the effects of this approach are not yet known; however, research suggests that increased communication among HCPs and patient-centered approaches to care are beneficial to patient outcomes, adherence, and public health.^1,5

Investigated Outcomes

As patients continue to enroll in MOSAIC, the effectiveness of the clinic will be evaluated. Specifically, quality of life, patient and HCP satisfaction with the program, adherence metrics, hospitalization rates, and all-cause mortality will be assessed for patients enrolled in MOSAIC as well as similar patients who are not enrolled in MOSAIC. Also, pharmacists will log all recommended medication therapy interventions so that the optimization component of MOSAIC may be quantified. GPRA measures and the financial implications of the interventions made by MOSAIC will also be evaluated.

Discussion

There are a number of factors, such as MTM services and interprofessional care teams, that research has shown to independently improve patient outcomes, adherence, or public health. By synthesizing these factors, a completely new approach—the Wheel Model of Pharmaceutical Care—was developed. This model presents a radical departure from traditional, requested-service practices and posits pharmacy as a provided service instead. Although the ideas of MTM and interprofessional care teams are not new, there has never been a practical way to truly integrate community pharmacists into the patient care team or to ensure adequate communication among all of the patient’s HCPs. The Wheel Model of Pharmaceutical Care includes public health as one of its core components and provides a framework for pharmacies to meaningfully impact health outcomes for patients.

The Wheel Model of Pharmaceutical Care was designed to minimize the likelihood of nonadherence. Despite this, patients might willfully choose to be nonadherent, forget to take their medications, or neglect to pick up their medications. Additionally, in health care systems where patients must pay for their medications, prescription drug costs might be a barrier to adherence.

When nonadherence is suspected, the Wheel Model of Pharmaceutical Care directs pharmacists in MOSAIC to take action. First, the underlying cause of the nonadherence must be determined. For example, if a patient is nonadherent because of an adverse drug reaction, a therapy change may be indicated. If a patient is nonadherent due to apathy toward their health or therapy, the patient may benefit from education about their condition and treatment options; thus, the patient can make shared, informed decisions and feel more actively involved with his or her health. If a patients is nonadherent due to forgetfulness, adherence packaging dispense methods should be considered as an alternative to traditional vials. Depending on the services offered by a given pharmacy, adherence packaging options may include blister packs, pill boxes, or strips prepared by robotic dispensing systems. The use of medication reminders, whether in the form of a smartphone application or a simple alarm clock, should be discussed with the patient. If the patient does not pick up their medications on time, a pharmacist can contact the patient to determine why the medications were not picked up and to assess any nonadherence. In this case, mail order pharmacy services, if available, should be offered to patients as a more convenient option.

The medication regimen optimization component of MOSAIC helps reduce the workload of primary care providers and allows pharmacists to act autonomously based on clinical judgment, within the scope of the CPA. This can prevent delays in care caused by no refills remaining on a prescription. The laboratory monitoring component allows pharmacists to track diseases and take action if necessary, which should have a favorable impact on GPRA measures. Medication optimizations can reduce wasted resources by identifying cost-saving formulary alternatives, potentially inappropriate medications, and suboptimal doses.

Since many Indian Health Service beneficiaries do not have private insurance and therefore do not generate third-party reimbursements for services and care provided by GIMC, keeping patients healthy and out of the hospital is a top priority. As more patients are enrolled in MOSAIC, the program is expected to have a favorable impact on pharmacy workload and workflow as well. Prescriptions are anticipated and filled in advance, which decreases the amount of patients calling and presenting to the pharmacy for same-day refill requests. Scheduling when MOSAIC patients’ medications are to be filled and dispensed creates a predictable workload that allows the pharmacy staff to be managed more efficiently.

Conclusion

Adherence is the responsibility of the patient, but the Wheel Model of Pharmaceutical Care aims to provide pharmacists with a framework to monitor and encourage adherence in their patients. By taking this patient-centered approach, MOSAIC is expected to improve outcomes and decrease hospitalizations for high-risk patients who simply need a little extra help with their medications.

Nonadherence is a significant problem that has a negative impact on both patients and public health. Patients with multiple diseases often have complicated medication regimens, which can be difficult for them to manage. Unfortunately, nonadherence in these high-risk patients can have drastic consequences, including disease progression, hospitalization, and death, resulting in billions of dollars in unnecessary costs nationwide.^1,2 The Wheel Model of Pharmaceutical Care (Figure) is a novel care model developed at the Gallup Indian Medical Center (GIMC) in New Mexico to address these problems by positioning pharmacy as a proactive service. The Wheel Model of Pharmaceutical Care was designed to improve adherence and patient outcomes and to encourage communication among the patient, pharmacists, prescribers, and other health care team members.

Pharmacists are central to managing patients’ medication therapies and coordinating communication among the health care providers (HCPs).^1,3 Medication therapy management (MTM), a required component of Medicare Part D plans, helps ensure appropriate drug use and reduce the risk of adverse events.³ Since pharmacists receive prescriptions from all of the patient’s HCPs, patients may see pharmacists more often than they see any other HCP. GIMC is currently piloting a new clinic, the Medication Optimization, Synchronization, and Adherence Improvement Clinic (MOSAIC), that was created to implement the Wheel Model of Pharmaceutical Care. MOSAIC aims to provide proactive pharmacy services and continuous MTM to high-risk patients and will enable the effectiveness of this new pharmaceutical care model to be assessed.

Methods

Studies have identified certain populations who are at an increased risk for nonadherence: the elderly, patients with complex or extensive medication regimens, patients with multiple chronic medical conditions, substance misusers, certain ethnicities, patients of lower socioeconomic status, patients with limited literacy, and the homeless.^2,4 Federal regulations require that Medicare Part D plans target beneficiaries who meet specific criteria for MTM programs. Under these rules, plans must target beneficiaries with ≥ 3 chronic diseases and ≥ 8 chronic medications, although plans also may include patients with fewer medications and diseases.³ Although the Wheel Model of Pharmaceutical Care is postulated to be an accurate model for the ideal care of all patients, initial implementation should be targeted toward populations who are likely to benefit the most from intervention. For these reasons, elderly Native American patients who have ≥ 2 chronic diseases and who take ≥ 5 chronic medications were targeted for initial enrollment in MOSAIC at GIMC.

Overview

In MOSAIC, pharmacists act as the hub of the pharmaceutical care wheel. Pharmacists work to ensure optimization of the patient’s comprehensive, integrated care plan—the rim of the wheel. As a part of this optimization process, MOSAIC pharmacists facilitate synchronization of the patient’s prescriptions to a monthly or quarterly target fill date. The patient’s current medication therapy is organized, and pharmacists track which medications are due to be filled instead of depending on the patient to request each prescription refill. This process effectively changes pharmacy from a requested service to a provided service.

Pharmacists also monitor the air in the tire to promote adherence. This is accomplished by providing efficient monthly or quarterly telephone or in-person consultations, which helps the patient better understand his or her comprehensive, integrated care plan. MOSAIC eliminates the possibility of nonadherence due to running out of refills. Specialized packaging, such as pill boxes or blister packs, can also improve adherence for certain patients.

MOSAIC ensures that pharmacists stay connected with the spokes, which represent a patient’s numerous prescribers, and close communication loops. Pharmacists can make prescribers aware of potential gaps or overlaps in treatment and assist them in the optimization and development of the patient’s comprehensive, integrated care plan. Pharmacists also make sure that the patient’s medication profile is current and accurate in the electronic health record (EHR). Any pertinent information discovered during MOSAIC encounters, such as abnormal laboratory results or changes in medications or disease, is documented in an EHR note. The patient’s prescribers are made aware of this information by tagging them as additional signers to the note in the EHR.

Keeping patients—the tires—healthy will ensure smooth operation of the vehicle and have a positive impact on public health. MOSAIC is expected to not only improve individual patient outcomes, but also decrease health care costs for patients and society due to nonadherence, suboptimal regimens, stockpiled home medications, and preventable hospital admissions.

Traditionally, pharmacy has been a requested service: A patient requests each of their prescriptions to be refilled, and the pharmacy fills the prescription. Ideally, pharmacy must become a provided service, with pharmacists keeping track of when a patient’s medications are due to be filled and actively looking for medication therapy optimization opportunities. This is accomplished by synchronizing the patient’s medications to the same monthly or quarterly fill date; screening for any potentially inappropriate medications, including high-risk medications in elderly patients, duplications, and omissions; verifying any medication changes with the patient each fill; and then providing all needed medications to the patient at a scheduled time.

To facilitate this process, custom software was developed for MOSAIC. In addition, a collaborative practice agreement (CPA) was drafted that allowed MOSAIC pharmacists to make certain medication therapy optimizations on behalf of the patient’s primary care provider. As part of this CPA, pharmacists also may order and act on certain laboratory tests, which helps to monitor disease progression, ensure safe medication use, and meet Government Performance and Results Act (GPRA) measures. As a novel model of pharmaceutical care, the effects of this approach are not yet known; however, research suggests that increased communication among HCPs and patient-centered approaches to care are beneficial to patient outcomes, adherence, and public health.^1,5

Investigated Outcomes

As patients continue to enroll in MOSAIC, the effectiveness of the clinic will be evaluated. Specifically, quality of life, patient and HCP satisfaction with the program, adherence metrics, hospitalization rates, and all-cause mortality will be assessed for patients enrolled in MOSAIC as well as similar patients who are not enrolled in MOSAIC. Also, pharmacists will log all recommended medication therapy interventions so that the optimization component of MOSAIC may be quantified. GPRA measures and the financial implications of the interventions made by MOSAIC will also be evaluated.

Discussion

There are a number of factors, such as MTM services and interprofessional care teams, that research has shown to independently improve patient outcomes, adherence, or public health. By synthesizing these factors, a completely new approach—the Wheel Model of Pharmaceutical Care—was developed. This model presents a radical departure from traditional, requested-service practices and posits pharmacy as a provided service instead. Although the ideas of MTM and interprofessional care teams are not new, there has never been a practical way to truly integrate community pharmacists into the patient care team or to ensure adequate communication among all of the patient’s HCPs. The Wheel Model of Pharmaceutical Care includes public health as one of its core components and provides a framework for pharmacies to meaningfully impact health outcomes for patients.

The Wheel Model of Pharmaceutical Care was designed to minimize the likelihood of nonadherence. Despite this, patients might willfully choose to be nonadherent, forget to take their medications, or neglect to pick up their medications. Additionally, in health care systems where patients must pay for their medications, prescription drug costs might be a barrier to adherence.

When nonadherence is suspected, the Wheel Model of Pharmaceutical Care directs pharmacists in MOSAIC to take action. First, the underlying cause of the nonadherence must be determined. For example, if a patient is nonadherent because of an adverse drug reaction, a therapy change may be indicated. If a patient is nonadherent due to apathy toward their health or therapy, the patient may benefit from education about their condition and treatment options; thus, the patient can make shared, informed decisions and feel more actively involved with his or her health. If a patients is nonadherent due to forgetfulness, adherence packaging dispense methods should be considered as an alternative to traditional vials. Depending on the services offered by a given pharmacy, adherence packaging options may include blister packs, pill boxes, or strips prepared by robotic dispensing systems. The use of medication reminders, whether in the form of a smartphone application or a simple alarm clock, should be discussed with the patient. If the patient does not pick up their medications on time, a pharmacist can contact the patient to determine why the medications were not picked up and to assess any nonadherence. In this case, mail order pharmacy services, if available, should be offered to patients as a more convenient option.

The medication regimen optimization component of MOSAIC helps reduce the workload of primary care providers and allows pharmacists to act autonomously based on clinical judgment, within the scope of the CPA. This can prevent delays in care caused by no refills remaining on a prescription. The laboratory monitoring component allows pharmacists to track diseases and take action if necessary, which should have a favorable impact on GPRA measures. Medication optimizations can reduce wasted resources by identifying cost-saving formulary alternatives, potentially inappropriate medications, and suboptimal doses.

Since many Indian Health Service beneficiaries do not have private insurance and therefore do not generate third-party reimbursements for services and care provided by GIMC, keeping patients healthy and out of the hospital is a top priority. As more patients are enrolled in MOSAIC, the program is expected to have a favorable impact on pharmacy workload and workflow as well. Prescriptions are anticipated and filled in advance, which decreases the amount of patients calling and presenting to the pharmacy for same-day refill requests. Scheduling when MOSAIC patients’ medications are to be filled and dispensed creates a predictable workload that allows the pharmacy staff to be managed more efficiently.

Conclusion

Adherence is the responsibility of the patient, but the Wheel Model of Pharmaceutical Care aims to provide pharmacists with a framework to monitor and encourage adherence in their patients. By taking this patient-centered approach, MOSAIC is expected to improve outcomes and decrease hospitalizations for high-risk patients who simply need a little extra help with their medications.

Nonadherence is a significant problem that has a negative impact on both patients and public health. Patients with multiple diseases often have complicated medication regimens, which can be difficult for them to manage. Unfortunately, nonadherence in these high-risk patients can have drastic consequences, including disease progression, hospitalization, and death, resulting in billions of dollars in unnecessary costs nationwide.^1,2 The Wheel Model of Pharmaceutical Care (Figure) is a novel care model developed at the Gallup Indian Medical Center (GIMC) in New Mexico to address these problems by positioning pharmacy as a proactive service. The Wheel Model of Pharmaceutical Care was designed to improve adherence and patient outcomes and to encourage communication among the patient, pharmacists, prescribers, and other health care team members.

Pharmacists are central to managing patients’ medication therapies and coordinating communication among the health care providers (HCPs).^1,3 Medication therapy management (MTM), a required component of Medicare Part D plans, helps ensure appropriate drug use and reduce the risk of adverse events.³ Since pharmacists receive prescriptions from all of the patient’s HCPs, patients may see pharmacists more often than they see any other HCP. GIMC is currently piloting a new clinic, the Medication Optimization, Synchronization, and Adherence Improvement Clinic (MOSAIC), that was created to implement the Wheel Model of Pharmaceutical Care. MOSAIC aims to provide proactive pharmacy services and continuous MTM to high-risk patients and will enable the effectiveness of this new pharmaceutical care model to be assessed.

Methods

Studies have identified certain populations who are at an increased risk for nonadherence: the elderly, patients with complex or extensive medication regimens, patients with multiple chronic medical conditions, substance misusers, certain ethnicities, patients of lower socioeconomic status, patients with limited literacy, and the homeless.^2,4 Federal regulations require that Medicare Part D plans target beneficiaries who meet specific criteria for MTM programs. Under these rules, plans must target beneficiaries with ≥ 3 chronic diseases and ≥ 8 chronic medications, although plans also may include patients with fewer medications and diseases.³ Although the Wheel Model of Pharmaceutical Care is postulated to be an accurate model for the ideal care of all patients, initial implementation should be targeted toward populations who are likely to benefit the most from intervention. For these reasons, elderly Native American patients who have ≥ 2 chronic diseases and who take ≥ 5 chronic medications were targeted for initial enrollment in MOSAIC at GIMC.

Overview

In MOSAIC, pharmacists act as the hub of the pharmaceutical care wheel. Pharmacists work to ensure optimization of the patient’s comprehensive, integrated care plan—the rim of the wheel. As a part of this optimization process, MOSAIC pharmacists facilitate synchronization of the patient’s prescriptions to a monthly or quarterly target fill date. The patient’s current medication therapy is organized, and pharmacists track which medications are due to be filled instead of depending on the patient to request each prescription refill. This process effectively changes pharmacy from a requested service to a provided service.

Pharmacists also monitor the air in the tire to promote adherence. This is accomplished by providing efficient monthly or quarterly telephone or in-person consultations, which helps the patient better understand his or her comprehensive, integrated care plan. MOSAIC eliminates the possibility of nonadherence due to running out of refills. Specialized packaging, such as pill boxes or blister packs, can also improve adherence for certain patients.

MOSAIC ensures that pharmacists stay connected with the spokes, which represent a patient’s numerous prescribers, and close communication loops. Pharmacists can make prescribers aware of potential gaps or overlaps in treatment and assist them in the optimization and development of the patient’s comprehensive, integrated care plan. Pharmacists also make sure that the patient’s medication profile is current and accurate in the electronic health record (EHR). Any pertinent information discovered during MOSAIC encounters, such as abnormal laboratory results or changes in medications or disease, is documented in an EHR note. The patient’s prescribers are made aware of this information by tagging them as additional signers to the note in the EHR.

Keeping patients—the tires—healthy will ensure smooth operation of the vehicle and have a positive impact on public health. MOSAIC is expected to not only improve individual patient outcomes, but also decrease health care costs for patients and society due to nonadherence, suboptimal regimens, stockpiled home medications, and preventable hospital admissions.

Traditionally, pharmacy has been a requested service: A patient requests each of their prescriptions to be refilled, and the pharmacy fills the prescription. Ideally, pharmacy must become a provided service, with pharmacists keeping track of when a patient’s medications are due to be filled and actively looking for medication therapy optimization opportunities. This is accomplished by synchronizing the patient’s medications to the same monthly or quarterly fill date; screening for any potentially inappropriate medications, including high-risk medications in elderly patients, duplications, and omissions; verifying any medication changes with the patient each fill; and then providing all needed medications to the patient at a scheduled time.

To facilitate this process, custom software was developed for MOSAIC. In addition, a collaborative practice agreement (CPA) was drafted that allowed MOSAIC pharmacists to make certain medication therapy optimizations on behalf of the patient’s primary care provider. As part of this CPA, pharmacists also may order and act on certain laboratory tests, which helps to monitor disease progression, ensure safe medication use, and meet Government Performance and Results Act (GPRA) measures. As a novel model of pharmaceutical care, the effects of this approach are not yet known; however, research suggests that increased communication among HCPs and patient-centered approaches to care are beneficial to patient outcomes, adherence, and public health.^1,5

Investigated Outcomes

As patients continue to enroll in MOSAIC, the effectiveness of the clinic will be evaluated. Specifically, quality of life, patient and HCP satisfaction with the program, adherence metrics, hospitalization rates, and all-cause mortality will be assessed for patients enrolled in MOSAIC as well as similar patients who are not enrolled in MOSAIC. Also, pharmacists will log all recommended medication therapy interventions so that the optimization component of MOSAIC may be quantified. GPRA measures and the financial implications of the interventions made by MOSAIC will also be evaluated.

Discussion

There are a number of factors, such as MTM services and interprofessional care teams, that research has shown to independently improve patient outcomes, adherence, or public health. By synthesizing these factors, a completely new approach—the Wheel Model of Pharmaceutical Care—was developed. This model presents a radical departure from traditional, requested-service practices and posits pharmacy as a provided service instead. Although the ideas of MTM and interprofessional care teams are not new, there has never been a practical way to truly integrate community pharmacists into the patient care team or to ensure adequate communication among all of the patient’s HCPs. The Wheel Model of Pharmaceutical Care includes public health as one of its core components and provides a framework for pharmacies to meaningfully impact health outcomes for patients.

The Wheel Model of Pharmaceutical Care was designed to minimize the likelihood of nonadherence. Despite this, patients might willfully choose to be nonadherent, forget to take their medications, or neglect to pick up their medications. Additionally, in health care systems where patients must pay for their medications, prescription drug costs might be a barrier to adherence.

When nonadherence is suspected, the Wheel Model of Pharmaceutical Care directs pharmacists in MOSAIC to take action. First, the underlying cause of the nonadherence must be determined. For example, if a patient is nonadherent because of an adverse drug reaction, a therapy change may be indicated. If a patient is nonadherent due to apathy toward their health or therapy, the patient may benefit from education about their condition and treatment options; thus, the patient can make shared, informed decisions and feel more actively involved with his or her health. If a patients is nonadherent due to forgetfulness, adherence packaging dispense methods should be considered as an alternative to traditional vials. Depending on the services offered by a given pharmacy, adherence packaging options may include blister packs, pill boxes, or strips prepared by robotic dispensing systems. The use of medication reminders, whether in the form of a smartphone application or a simple alarm clock, should be discussed with the patient. If the patient does not pick up their medications on time, a pharmacist can contact the patient to determine why the medications were not picked up and to assess any nonadherence. In this case, mail order pharmacy services, if available, should be offered to patients as a more convenient option.

The medication regimen optimization component of MOSAIC helps reduce the workload of primary care providers and allows pharmacists to act autonomously based on clinical judgment, within the scope of the CPA. This can prevent delays in care caused by no refills remaining on a prescription. The laboratory monitoring component allows pharmacists to track diseases and take action if necessary, which should have a favorable impact on GPRA measures. Medication optimizations can reduce wasted resources by identifying cost-saving formulary alternatives, potentially inappropriate medications, and suboptimal doses.

Since many Indian Health Service beneficiaries do not have private insurance and therefore do not generate third-party reimbursements for services and care provided by GIMC, keeping patients healthy and out of the hospital is a top priority. As more patients are enrolled in MOSAIC, the program is expected to have a favorable impact on pharmacy workload and workflow as well. Prescriptions are anticipated and filled in advance, which decreases the amount of patients calling and presenting to the pharmacy for same-day refill requests. Scheduling when MOSAIC patients’ medications are to be filled and dispensed creates a predictable workload that allows the pharmacy staff to be managed more efficiently.

Conclusion

Adherence is the responsibility of the patient, but the Wheel Model of Pharmaceutical Care aims to provide pharmacists with a framework to monitor and encourage adherence in their patients. By taking this patient-centered approach, MOSAIC is expected to improve outcomes and decrease hospitalizations for high-risk patients who simply need a little extra help with their medications.

The term cataract is derived from the Latin word “catarractes,” which means “waterfall,” as the foamy white opacity of an advanced cataract can be likened to a tempestuous cascade. Cataract is the leading cause of preventable blindness worldwide.^1,2 It is no surprise, therefore, that cataract surgery is the most frequently performed ophthalmic surgical procedure worldwide. Cataract surgeries may reach 30 million annual cases by 2020.³ Given the large number of surgeries being performed, postsurgical complications are not uncommon.

Early postoperative complications from lens exchange (cataract) surgery include increased intraocular pressure (IOP), corneal edema, and corneal wound leakage.⁴ Corneal wound leakage is not uncommon; one study showed that, in 100 cases, almost one-third of incisions leaked.⁵ A 2014 prospective study of 500 postcataract surgery eyes revealed that 48.8% had fluid egress.⁶ Early detection is important so that efforts to restore corneal integrity can immediately be implemented. If not caught early, patients are at risk for developing a cascade of sequelae, including endophthalmitis.

The majority of corneal wound leaks postphacoemulsification are self-limiting and self-sealing. Moderate wound leaks require treatment, as in the following case. Strategies to detect, image, and treat wound leaks are covered in this discussion.

Case Presentation

A 69-year-old male veteran presented with no complaints for a 1-day postoperative visit following right eye phacoemulsification cataract extraction. His best corrected visual acuity in the right eye was 20/40, and his pinhole visual acuity was 20/25+2. On slit-lamp examination, the temporally located main incision appeared well-adhered and was found to be Seidel negative; however, the inferior paracentesis wound was found to be Seidel positive, demonstrating a slow leak. Intraocular pressure (IOP) measured with tonopen was 9 mm Hg.

A bandage soft contact lens was placed on the eye. The patient was instructed not to rub or place any pressure on the eye and to avoid bending and heavy lifting. He was also instructed to continue his postoperative medications (prednisolone 1% every 2 hours and polymyxin B sulfate 4 times daily) in his right eye. A follow-up appointment was scheduled for the next day.

The patient presented for his postoperative day-2 visit with a best corrected visual acuity in the right eye of 20/20. He reported no visual problems, no eye pain, and mentioned that he had had a comfortable night sleep. A slit-lamp examination revealed trace diffuse injection in the operative eye, predominantly central Descemet membrane folds, 1+ stromal edema, and a Seidel negative main incision wound. However, the inferior paracentesis wound showed a moderate leak (Seidel positive), and the anterior chamber showed a 1+ cell and flare. Goldmann tonometry revealed an IOP of 5 mm Hg, indicating hypotony.

Anterior segment cube 512 x 128 optical coherence tomography (OCT) was obtained with the bandage contact lens (Figures 1 and 2), and then repeated with the bandage contact lens removed (Figures 3 and 4). OCT imaging confirmed epithelial and endothelial gaping, loss of coaptation, and a localized detachment of the Descemet membrane. The veteran was referred to his surgeon that same day, and 2 limbal vicryl sutures were placed. The patient was instructed to continue prednisolone 1% 4 times daily and polymyxin B sulfate every 2 hours; erythromycin ointment 3 times daily was added to his regimen.

He was scheduled for a follow-up examination 1 week later. At that visit, the wound was no longer leaking and IOP had risen to a preoperative value of 17 mm Hg. The corneal sutures were removed at the 1-month postoperative examination and a follow-up was scheduled for 4 months later. An anterior segment OCT was obtained (Figure 5).

Discussion

In July 1967, Charles Kelman, MD, suggested using a dental ultrasonic tool, normally employed to clean teeth, to fragment the nucleus of the crystalline lens. Dr. Kelman’s first operation using phacoemulsification on a human eye took 3 hours.⁷ As the procedure for cataract removal has been refined, complication rates and surgical times have vastly improved.

Phacoemulsification is the most commonly performed outpatient surgery in the US; about 3 million cases are performed annually. Due to the high volume of cases, adverse events (AEs) are not uncommon. The incidence of complications following phacoemulsification is < 5%; the frequency of severe complications has been estimated at < 0.7%.⁸ Severe complications include endophthalmitis, suprachoroidal hemorrhage, and/or retinal detachment.⁹ Studies have shown a decline in rates of sight-threatening AEs from 1994 to 2006.⁹ A retrospective study of 45,082 veterans from 2005 to 2007 identified that a preoperative disease burden such as diabetes mellitus, chronic pulmonary disease, age-related macular degeneration, and diabetes with ophthalmic manifestations, was positively associated with a greater risk of cataract surgical complications.¹⁰

Complications

The level of a surgeon’s proficiency with phacoemulsification is directly correlated to the number of operations performed; there is a lower complication rate among more experienced surgeons, including those who work in high-volume settings.^11,12 One study identified that the AE rate within 14 days of surgery was 0.8% for surgeons performing 50 to 250 cataract surgeries per year, but only 0.1% for those performing > 1000 cataract surgeries annually.¹²

Potential postoperative lens exchange complications include increased IOP, corneal wound leakage, corneal edema, bullous keratopathy, cystoid macular edema, retinal detachment, and endophthalmitis (Table 1). A corneal wound leak can provide a potential ingress for bacteria, putting the patient at risk for endophthalmitis, perhaps the most devastating complication following cataract surgery.

Endophthalmitis

Endophthalmitis has been reported to occur in .001% to .327% of patients during postoperative care.^5,13-17 Early detection is important to maintain corneal integrity and prevent a cascade of detrimental ocular sequalae including the potential for endophthalmitis. According to Zaida and colleagues, endophthalmitis occurred in fewer than 1 of 1000 consecutive cases.¹⁴ A leaking clear corneal incision wound on the first day postoperatively has been associated with a 44-fold increased risk of endophthalmitis.¹³

Causes of endophthalmitis

In a retrospective case-controlled series of 57 patients with postcataract endophthalmitis, implantation of an intraocular lens with a resultant wound abnormality was thought to be the causative factor in 5%.¹⁷ Another source of endophthalmitis can be the intraocular lens (IOL), which may act as a vector for bacteria. By placing the IOL against the conjunctiva or exposing it to the theater air during surgery, bacteria can be introduced prior to implantation.¹⁷ Immunosuppressive treatment is the only patient antecedent factor that can be considered a predictor for endopthalmitis.¹⁷

The internal corneal seal is IOP dependent, and postoperative ocular hypotony may cause a seemingly watertight wound to leak. Taban and colleagues used anterior segment OCT to image numerous self-sealing incisions. They found that the corneal incision wound more tightly seals at higher IOPs. Additionally, more perpendicular (larger angle) incisions seal better at a lower IOP while less perpendicular (smaller angle) incisions seal better at a higher IOP (Figure 6).¹⁸

Incision Placement

Studies have shown that the main incision site is more clinically competent than is the side port incision site, as in our case study.¹⁹ Side-port incisions have a 1- or 2-plane architectural profile in contrast to the 3-plane profile typical of a main incision.¹⁹ Recent advances including the conversion to clear-corneal incisions of diminishing size, techniques used for wound construction, phacoemulsification machine design, and small-incision IOLs, should further reduce the prevalence and complications of wound compromise.²⁰

Seidel Testing

Seidel testing is the most common method to evaluate corneal wound integrity and identify leaks. A drop of topical anesthetic is instilled in the eye and then a fluorescein strip (not fluorescein sodium and benoxinate hydrochloride ophthalmic solution, which may become less sterile since it has a multiuse container) is applied to the superior conjunctiva. The clinician then looks for evidence of fluid egress using the cobalt blue filter. The patient is instructed to blink once. Fluid egress appears as a black stream as the fluorescein dye becomes diluted by aqueous humor escaping the nonintact wound and the appearance of bright green dye surrounds the leak site. The term Seidel positive indicates a leak. An estimate should be made of the rate and volume of fluid exiting the wound.

Gonioscopy

Gonioscopy can be used to evaluate the postsurgical incision, more specifically for identification and management of internal incision wound gape. On gonioscopy, internal wound gape appears as an elongated oval opening resembling a fish mouth. If internal incision wound gape is identified gonioscopically before surgery is complete, the leak can be managed intraoperatively. The surgeon can irrigate along the length of the incision to remove cortical fragments or viscoelastic that may cause internal wound gaping. If unsuccessful, rapidly deepening the anterior chamber with balanced salt solution through the paracentesis incision may be employed. These methods may improve wound stability, reduce risk of postoperative hyphema, lower the incidence of endophthalmitis, and lessen the likelihood of late against-the-rule drift.²¹

Anterior Segment Optical Coherence Tomography

Instances when Seidel testing was negative despite actual wound gaping have been described.^22,23 Anterior segment OCT is useful to evaluate incision architecture. A 2007 United Kingdom study investigated the corneal architecture in the immediate postoperative period following phacoemulsification using anterior segment OCT. This study showed the benefits of identifying architectural features such as epithelial gaping, endothelial gaping, stripping of Descemet membrane, and loss of coaptation. These features were found to be more common at low IOP and could represent a significant risk factor for endophthalmitis.²⁴ Another study published by Behrens and colleagues indicated that a localized detachment of Descemet membrane may be more common than observed with slit-lamp (Figure 7). Corneal gaping, especially if along the entire length of the surgical wound, may lead to inadvertent bacterial access into the anterior chamber.²⁵ 

Anterior segment OCT imaging was first described by Izatt and colleagues in 1994.²⁶ Unlike posterior segment OCT, anterior segment OCT requires a greater depth of field and higher energy levels as images are commonly distorted by refraction at boundaries where the refractive index changes. Longer infrared wavelengths improve the penetration through tissues that scatter light, such as the sclera and limbus, which allows visualization, for example, of the iridocorneal angle.^27,28

Two main scan patterns are used for anterior segment OCT: 512 x 128 cube scan (4-mm width x 4-mm length) and 5-line raster (3-mm length) with adjustable rotation and spacing. A recent software update allows measurement of corneal thickness, visualization of anterior chamber angle structures along with topographic analysis, anterior and posterior elevation maps of the cornea, and reliable pachymetric maps.^29,30 The anterior segment cube acquires a series of 128 horizontal scan lines each composed of 512 A-scans. These high-definition scans acquire vertical and horizontal directions composed of 1024 A-scans each. This cube may be used to measure corneal thickness and visualize corneal architecture, creating a 3-D image of the data (Figure 8). The anterior segment 5-line raster scans through 5 parallel lines of equal length to view high-resolution images of the anterior chamber angle and cornea. Each line, fixed at 3-mm in length, is composed of 4096 A-scans.³¹ Anterior segment cube OCT allows identification of subtle variations in incision architecture at different locations across the width of the OCT image.

Bandage Soft Contact Lens

Upon reviewing the anterior segment OCT images of our patient with the bandage contact lens in place, it was evident that the adherent ocular bandage was protecting the incision. A tighter fitting bandage contact lens is ideal and adheres firmly to any area of epithelial damage and epithelial gaping to help seal the incision, protecting the wound and improving structural integrity. The bandage contact lens is gradually replaced by new cells via re-epithelialization; thus, it behaves as an adjunct to natural wound healing. A bandage contact lens also improves patient comfort.

It is hypothesized that a bandage contact lens improves the structural integrity of the incision site and helps prevent leaking, hypotony, and minor wound leaks. One study revealed a statistically significant lower IOP in nonbandage contact lens patients by an average of 6 mm Hg (mean [SD] 13.4 mm Hg [5.3]; range, 5 - 23 mm Hg) vs patients with a bandage contact lens (mean [SD] 19.4 mm Hg [5.9]; range, 11 - 29 mm Hg) in the immediate postoperative period.³² The authors suggested that the bandage contact lens may prevent microleaks, resulting in a higher IOP.

Aqueous Suppressants

Aqueous suppressants are a great option when IOP is abnormally elevated by decreasing the IOP and allowing the cornea to heal and self-seal.Effective aqueous suppressants are β blockers and carbonic anhydrase inhibitors.

After phacoemulsification ocular hypotony (< 6 mm Hg) occurs most commonly due to wound leakage or excessive intraocular inflammation. However, with the presence of corneal wound leakage and ocular hypotony, aqueous suppressants are not the best option.

Further Management of Wound Leaks

Management of a postoperative wound leak will vary based on severity. The majority of mild leaks are self-sealing. Anterior segment OCT helps the clinician to identify microleaks in an otherwise Seidel negative eye. If wound leakage is moderate with a formed anterior chamber, the use of a bandage contact lens is a good option, as can be the prescription of aqueous suppressants, depending on IOP.³³

If the anterior chamber is flat, iris prolapse is apparent, or extremely low IOP exists, the patient needs to be referred to the surgeon. Current standard of care directs the surgeon to use sutures to further manage corneal wound leak. However, several studies have recognized the increased risk of suture-related complications, such as induced astigmatism, corneal opacities, incomplete wound closure, and corneal neovascularization.^6,34-38 Other wound closure options include polyethylene glycol-based products, corneal welding, cyanoacrylate, or fibrin (Table 2).³⁹ Traditionally nylon sutures have been used for clear corneal incision wound closure. However, tissue adhesives are gaining popularity as a substitute for sutures in wound closure.⁴⁰

Cyanoacrylate

Numerous studies have been published on the efficacy of cyanoacrylate as a substitute for sutures, specifically in clear corneal incisions. AEs of cyanoacrylate include a transient foreign-body sensation and diffuse or focal bulbar conjunctival hyperemia.^41,42 Shigemitsu and Majima found that fibrin and cyanoacrylate glue had tensile strength similar to sutures when used in cataract surgery.39 
Polyethylene glycol-based products, also used in artificial tears and contact lens materials, may also help seal wound leaks. Another agent is ReSure (Ocular Therapeutix, Bedford, MA), an FDA-approved synthetic, polyethylene glycol hydrogel sealant that is 90% water after polymerization. ReSure has been shown to be safe and effective in sealing cataract surgical clear corneal incisions.^6,43 ReSure takes about 20 seconds to prepare, and placement is aided by the use of a blue dye that dissipates within hours. This hydrogel will gradually slough off in the tears once the tissue has fully regenerated; there is no need to remove the sealant.⁴⁴

Rossi and colleagues evaluated the efficacy of corneal welding to close wounds after cataract surgery. The technique involves laser-assisted closure of the corneal wound(s) by a diode laser that welds the stroma.⁴⁵ Corneal welding takes seconds to achieve good closure without significant astigmatism or inflammation; however very careful application of the light absorbing dyes is required as they are toxic if allowed to enter the anterior chamber.^45-47

Conclusion

Optometrists may be called to manage patients during both the preoperative and postoperative phases of cataract surgical care. Those who participate in postoperative care should carefully evaluate for the presence of wound leak or wound gape as a potential complication. The OCT may be employed to evaluate patients suspected of having these leaks or gapes. Proficiency in the interpretation of OCT results and more traditional evaluation methods allows for successful detection of wound leaks or gapes. The timely diagnosis and treatment of postoperative wound leaks allow for the best possible outcomes for cataract surgery patients.

The term cataract is derived from the Latin word “catarractes,” which means “waterfall,” as the foamy white opacity of an advanced cataract can be likened to a tempestuous cascade. Cataract is the leading cause of preventable blindness worldwide.^1,2 It is no surprise, therefore, that cataract surgery is the most frequently performed ophthalmic surgical procedure worldwide. Cataract surgeries may reach 30 million annual cases by 2020.³ Given the large number of surgeries being performed, postsurgical complications are not uncommon.

Early postoperative complications from lens exchange (cataract) surgery include increased intraocular pressure (IOP), corneal edema, and corneal wound leakage.⁴ Corneal wound leakage is not uncommon; one study showed that, in 100 cases, almost one-third of incisions leaked.⁵ A 2014 prospective study of 500 postcataract surgery eyes revealed that 48.8% had fluid egress.⁶ Early detection is important so that efforts to restore corneal integrity can immediately be implemented. If not caught early, patients are at risk for developing a cascade of sequelae, including endophthalmitis.

The majority of corneal wound leaks postphacoemulsification are self-limiting and self-sealing. Moderate wound leaks require treatment, as in the following case. Strategies to detect, image, and treat wound leaks are covered in this discussion.

Case Presentation

A 69-year-old male veteran presented with no complaints for a 1-day postoperative visit following right eye phacoemulsification cataract extraction. His best corrected visual acuity in the right eye was 20/40, and his pinhole visual acuity was 20/25+2. On slit-lamp examination, the temporally located main incision appeared well-adhered and was found to be Seidel negative; however, the inferior paracentesis wound was found to be Seidel positive, demonstrating a slow leak. Intraocular pressure (IOP) measured with tonopen was 9 mm Hg.

A bandage soft contact lens was placed on the eye. The patient was instructed not to rub or place any pressure on the eye and to avoid bending and heavy lifting. He was also instructed to continue his postoperative medications (prednisolone 1% every 2 hours and polymyxin B sulfate 4 times daily) in his right eye. A follow-up appointment was scheduled for the next day.

The patient presented for his postoperative day-2 visit with a best corrected visual acuity in the right eye of 20/20. He reported no visual problems, no eye pain, and mentioned that he had had a comfortable night sleep. A slit-lamp examination revealed trace diffuse injection in the operative eye, predominantly central Descemet membrane folds, 1+ stromal edema, and a Seidel negative main incision wound. However, the inferior paracentesis wound showed a moderate leak (Seidel positive), and the anterior chamber showed a 1+ cell and flare. Goldmann tonometry revealed an IOP of 5 mm Hg, indicating hypotony.

Anterior segment cube 512 x 128 optical coherence tomography (OCT) was obtained with the bandage contact lens (Figures 1 and 2), and then repeated with the bandage contact lens removed (Figures 3 and 4). OCT imaging confirmed epithelial and endothelial gaping, loss of coaptation, and a localized detachment of the Descemet membrane. The veteran was referred to his surgeon that same day, and 2 limbal vicryl sutures were placed. The patient was instructed to continue prednisolone 1% 4 times daily and polymyxin B sulfate every 2 hours; erythromycin ointment 3 times daily was added to his regimen.

He was scheduled for a follow-up examination 1 week later. At that visit, the wound was no longer leaking and IOP had risen to a preoperative value of 17 mm Hg. The corneal sutures were removed at the 1-month postoperative examination and a follow-up was scheduled for 4 months later. An anterior segment OCT was obtained (Figure 5).

Discussion

In July 1967, Charles Kelman, MD, suggested using a dental ultrasonic tool, normally employed to clean teeth, to fragment the nucleus of the crystalline lens. Dr. Kelman’s first operation using phacoemulsification on a human eye took 3 hours.⁷ As the procedure for cataract removal has been refined, complication rates and surgical times have vastly improved.

Phacoemulsification is the most commonly performed outpatient surgery in the US; about 3 million cases are performed annually. Due to the high volume of cases, adverse events (AEs) are not uncommon. The incidence of complications following phacoemulsification is < 5%; the frequency of severe complications has been estimated at < 0.7%.⁸ Severe complications include endophthalmitis, suprachoroidal hemorrhage, and/or retinal detachment.⁹ Studies have shown a decline in rates of sight-threatening AEs from 1994 to 2006.⁹ A retrospective study of 45,082 veterans from 2005 to 2007 identified that a preoperative disease burden such as diabetes mellitus, chronic pulmonary disease, age-related macular degeneration, and diabetes with ophthalmic manifestations, was positively associated with a greater risk of cataract surgical complications.¹⁰

Complications

The level of a surgeon’s proficiency with phacoemulsification is directly correlated to the number of operations performed; there is a lower complication rate among more experienced surgeons, including those who work in high-volume settings.^11,12 One study identified that the AE rate within 14 days of surgery was 0.8% for surgeons performing 50 to 250 cataract surgeries per year, but only 0.1% for those performing > 1000 cataract surgeries annually.¹²

Potential postoperative lens exchange complications include increased IOP, corneal wound leakage, corneal edema, bullous keratopathy, cystoid macular edema, retinal detachment, and endophthalmitis (Table 1). A corneal wound leak can provide a potential ingress for bacteria, putting the patient at risk for endophthalmitis, perhaps the most devastating complication following cataract surgery.

Endophthalmitis

Endophthalmitis has been reported to occur in .001% to .327% of patients during postoperative care.^5,13-17 Early detection is important to maintain corneal integrity and prevent a cascade of detrimental ocular sequalae including the potential for endophthalmitis. According to Zaida and colleagues, endophthalmitis occurred in fewer than 1 of 1000 consecutive cases.¹⁴ A leaking clear corneal incision wound on the first day postoperatively has been associated with a 44-fold increased risk of endophthalmitis.¹³

Causes of endophthalmitis

In a retrospective case-controlled series of 57 patients with postcataract endophthalmitis, implantation of an intraocular lens with a resultant wound abnormality was thought to be the causative factor in 5%.¹⁷ Another source of endophthalmitis can be the intraocular lens (IOL), which may act as a vector for bacteria. By placing the IOL against the conjunctiva or exposing it to the theater air during surgery, bacteria can be introduced prior to implantation.¹⁷ Immunosuppressive treatment is the only patient antecedent factor that can be considered a predictor for endopthalmitis.¹⁷

The internal corneal seal is IOP dependent, and postoperative ocular hypotony may cause a seemingly watertight wound to leak. Taban and colleagues used anterior segment OCT to image numerous self-sealing incisions. They found that the corneal incision wound more tightly seals at higher IOPs. Additionally, more perpendicular (larger angle) incisions seal better at a lower IOP while less perpendicular (smaller angle) incisions seal better at a higher IOP (Figure 6).¹⁸

Incision Placement

Studies have shown that the main incision site is more clinically competent than is the side port incision site, as in our case study.¹⁹ Side-port incisions have a 1- or 2-plane architectural profile in contrast to the 3-plane profile typical of a main incision.¹⁹ Recent advances including the conversion to clear-corneal incisions of diminishing size, techniques used for wound construction, phacoemulsification machine design, and small-incision IOLs, should further reduce the prevalence and complications of wound compromise.²⁰

Seidel Testing

Seidel testing is the most common method to evaluate corneal wound integrity and identify leaks. A drop of topical anesthetic is instilled in the eye and then a fluorescein strip (not fluorescein sodium and benoxinate hydrochloride ophthalmic solution, which may become less sterile since it has a multiuse container) is applied to the superior conjunctiva. The clinician then looks for evidence of fluid egress using the cobalt blue filter. The patient is instructed to blink once. Fluid egress appears as a black stream as the fluorescein dye becomes diluted by aqueous humor escaping the nonintact wound and the appearance of bright green dye surrounds the leak site. The term Seidel positive indicates a leak. An estimate should be made of the rate and volume of fluid exiting the wound.

Gonioscopy

Gonioscopy can be used to evaluate the postsurgical incision, more specifically for identification and management of internal incision wound gape. On gonioscopy, internal wound gape appears as an elongated oval opening resembling a fish mouth. If internal incision wound gape is identified gonioscopically before surgery is complete, the leak can be managed intraoperatively. The surgeon can irrigate along the length of the incision to remove cortical fragments or viscoelastic that may cause internal wound gaping. If unsuccessful, rapidly deepening the anterior chamber with balanced salt solution through the paracentesis incision may be employed. These methods may improve wound stability, reduce risk of postoperative hyphema, lower the incidence of endophthalmitis, and lessen the likelihood of late against-the-rule drift.²¹

Anterior Segment Optical Coherence Tomography

Instances when Seidel testing was negative despite actual wound gaping have been described.^22,23 Anterior segment OCT is useful to evaluate incision architecture. A 2007 United Kingdom study investigated the corneal architecture in the immediate postoperative period following phacoemulsification using anterior segment OCT. This study showed the benefits of identifying architectural features such as epithelial gaping, endothelial gaping, stripping of Descemet membrane, and loss of coaptation. These features were found to be more common at low IOP and could represent a significant risk factor for endophthalmitis.²⁴ Another study published by Behrens and colleagues indicated that a localized detachment of Descemet membrane may be more common than observed with slit-lamp (Figure 7). Corneal gaping, especially if along the entire length of the surgical wound, may lead to inadvertent bacterial access into the anterior chamber.²⁵ 

Anterior segment OCT imaging was first described by Izatt and colleagues in 1994.²⁶ Unlike posterior segment OCT, anterior segment OCT requires a greater depth of field and higher energy levels as images are commonly distorted by refraction at boundaries where the refractive index changes. Longer infrared wavelengths improve the penetration through tissues that scatter light, such as the sclera and limbus, which allows visualization, for example, of the iridocorneal angle.^27,28

Two main scan patterns are used for anterior segment OCT: 512 x 128 cube scan (4-mm width x 4-mm length) and 5-line raster (3-mm length) with adjustable rotation and spacing. A recent software update allows measurement of corneal thickness, visualization of anterior chamber angle structures along with topographic analysis, anterior and posterior elevation maps of the cornea, and reliable pachymetric maps.^29,30 The anterior segment cube acquires a series of 128 horizontal scan lines each composed of 512 A-scans. These high-definition scans acquire vertical and horizontal directions composed of 1024 A-scans each. This cube may be used to measure corneal thickness and visualize corneal architecture, creating a 3-D image of the data (Figure 8). The anterior segment 5-line raster scans through 5 parallel lines of equal length to view high-resolution images of the anterior chamber angle and cornea. Each line, fixed at 3-mm in length, is composed of 4096 A-scans.³¹ Anterior segment cube OCT allows identification of subtle variations in incision architecture at different locations across the width of the OCT image.

Bandage Soft Contact Lens

Upon reviewing the anterior segment OCT images of our patient with the bandage contact lens in place, it was evident that the adherent ocular bandage was protecting the incision. A tighter fitting bandage contact lens is ideal and adheres firmly to any area of epithelial damage and epithelial gaping to help seal the incision, protecting the wound and improving structural integrity. The bandage contact lens is gradually replaced by new cells via re-epithelialization; thus, it behaves as an adjunct to natural wound healing. A bandage contact lens also improves patient comfort.

It is hypothesized that a bandage contact lens improves the structural integrity of the incision site and helps prevent leaking, hypotony, and minor wound leaks. One study revealed a statistically significant lower IOP in nonbandage contact lens patients by an average of 6 mm Hg (mean [SD] 13.4 mm Hg [5.3]; range, 5 - 23 mm Hg) vs patients with a bandage contact lens (mean [SD] 19.4 mm Hg [5.9]; range, 11 - 29 mm Hg) in the immediate postoperative period.³² The authors suggested that the bandage contact lens may prevent microleaks, resulting in a higher IOP.

Aqueous Suppressants

Aqueous suppressants are a great option when IOP is abnormally elevated by decreasing the IOP and allowing the cornea to heal and self-seal.Effective aqueous suppressants are β blockers and carbonic anhydrase inhibitors.

After phacoemulsification ocular hypotony (< 6 mm Hg) occurs most commonly due to wound leakage or excessive intraocular inflammation. However, with the presence of corneal wound leakage and ocular hypotony, aqueous suppressants are not the best option.

Further Management of Wound Leaks

Management of a postoperative wound leak will vary based on severity. The majority of mild leaks are self-sealing. Anterior segment OCT helps the clinician to identify microleaks in an otherwise Seidel negative eye. If wound leakage is moderate with a formed anterior chamber, the use of a bandage contact lens is a good option, as can be the prescription of aqueous suppressants, depending on IOP.³³

If the anterior chamber is flat, iris prolapse is apparent, or extremely low IOP exists, the patient needs to be referred to the surgeon. Current standard of care directs the surgeon to use sutures to further manage corneal wound leak. However, several studies have recognized the increased risk of suture-related complications, such as induced astigmatism, corneal opacities, incomplete wound closure, and corneal neovascularization.^6,34-38 Other wound closure options include polyethylene glycol-based products, corneal welding, cyanoacrylate, or fibrin (Table 2).³⁹ Traditionally nylon sutures have been used for clear corneal incision wound closure. However, tissue adhesives are gaining popularity as a substitute for sutures in wound closure.⁴⁰

Cyanoacrylate

Numerous studies have been published on the efficacy of cyanoacrylate as a substitute for sutures, specifically in clear corneal incisions. AEs of cyanoacrylate include a transient foreign-body sensation and diffuse or focal bulbar conjunctival hyperemia.^41,42 Shigemitsu and Majima found that fibrin and cyanoacrylate glue had tensile strength similar to sutures when used in cataract surgery.39 
Polyethylene glycol-based products, also used in artificial tears and contact lens materials, may also help seal wound leaks. Another agent is ReSure (Ocular Therapeutix, Bedford, MA), an FDA-approved synthetic, polyethylene glycol hydrogel sealant that is 90% water after polymerization. ReSure has been shown to be safe and effective in sealing cataract surgical clear corneal incisions.^6,43 ReSure takes about 20 seconds to prepare, and placement is aided by the use of a blue dye that dissipates within hours. This hydrogel will gradually slough off in the tears once the tissue has fully regenerated; there is no need to remove the sealant.⁴⁴

Rossi and colleagues evaluated the efficacy of corneal welding to close wounds after cataract surgery. The technique involves laser-assisted closure of the corneal wound(s) by a diode laser that welds the stroma.⁴⁵ Corneal welding takes seconds to achieve good closure without significant astigmatism or inflammation; however very careful application of the light absorbing dyes is required as they are toxic if allowed to enter the anterior chamber.^45-47

Conclusion

Optometrists may be called to manage patients during both the preoperative and postoperative phases of cataract surgical care. Those who participate in postoperative care should carefully evaluate for the presence of wound leak or wound gape as a potential complication. The OCT may be employed to evaluate patients suspected of having these leaks or gapes. Proficiency in the interpretation of OCT results and more traditional evaluation methods allows for successful detection of wound leaks or gapes. The timely diagnosis and treatment of postoperative wound leaks allow for the best possible outcomes for cataract surgery patients.

The term cataract is derived from the Latin word “catarractes,” which means “waterfall,” as the foamy white opacity of an advanced cataract can be likened to a tempestuous cascade. Cataract is the leading cause of preventable blindness worldwide.^1,2 It is no surprise, therefore, that cataract surgery is the most frequently performed ophthalmic surgical procedure worldwide. Cataract surgeries may reach 30 million annual cases by 2020.³ Given the large number of surgeries being performed, postsurgical complications are not uncommon.

Early postoperative complications from lens exchange (cataract) surgery include increased intraocular pressure (IOP), corneal edema, and corneal wound leakage.⁴ Corneal wound leakage is not uncommon; one study showed that, in 100 cases, almost one-third of incisions leaked.⁵ A 2014 prospective study of 500 postcataract surgery eyes revealed that 48.8% had fluid egress.⁶ Early detection is important so that efforts to restore corneal integrity can immediately be implemented. If not caught early, patients are at risk for developing a cascade of sequelae, including endophthalmitis.

The majority of corneal wound leaks postphacoemulsification are self-limiting and self-sealing. Moderate wound leaks require treatment, as in the following case. Strategies to detect, image, and treat wound leaks are covered in this discussion.

Case Presentation

A 69-year-old male veteran presented with no complaints for a 1-day postoperative visit following right eye phacoemulsification cataract extraction. His best corrected visual acuity in the right eye was 20/40, and his pinhole visual acuity was 20/25+2. On slit-lamp examination, the temporally located main incision appeared well-adhered and was found to be Seidel negative; however, the inferior paracentesis wound was found to be Seidel positive, demonstrating a slow leak. Intraocular pressure (IOP) measured with tonopen was 9 mm Hg.

A bandage soft contact lens was placed on the eye. The patient was instructed not to rub or place any pressure on the eye and to avoid bending and heavy lifting. He was also instructed to continue his postoperative medications (prednisolone 1% every 2 hours and polymyxin B sulfate 4 times daily) in his right eye. A follow-up appointment was scheduled for the next day.

The patient presented for his postoperative day-2 visit with a best corrected visual acuity in the right eye of 20/20. He reported no visual problems, no eye pain, and mentioned that he had had a comfortable night sleep. A slit-lamp examination revealed trace diffuse injection in the operative eye, predominantly central Descemet membrane folds, 1+ stromal edema, and a Seidel negative main incision wound. However, the inferior paracentesis wound showed a moderate leak (Seidel positive), and the anterior chamber showed a 1+ cell and flare. Goldmann tonometry revealed an IOP of 5 mm Hg, indicating hypotony.

Anterior segment cube 512 x 128 optical coherence tomography (OCT) was obtained with the bandage contact lens (Figures 1 and 2), and then repeated with the bandage contact lens removed (Figures 3 and 4). OCT imaging confirmed epithelial and endothelial gaping, loss of coaptation, and a localized detachment of the Descemet membrane. The veteran was referred to his surgeon that same day, and 2 limbal vicryl sutures were placed. The patient was instructed to continue prednisolone 1% 4 times daily and polymyxin B sulfate every 2 hours; erythromycin ointment 3 times daily was added to his regimen.

He was scheduled for a follow-up examination 1 week later. At that visit, the wound was no longer leaking and IOP had risen to a preoperative value of 17 mm Hg. The corneal sutures were removed at the 1-month postoperative examination and a follow-up was scheduled for 4 months later. An anterior segment OCT was obtained (Figure 5).

Discussion

In July 1967, Charles Kelman, MD, suggested using a dental ultrasonic tool, normally employed to clean teeth, to fragment the nucleus of the crystalline lens. Dr. Kelman’s first operation using phacoemulsification on a human eye took 3 hours.⁷ As the procedure for cataract removal has been refined, complication rates and surgical times have vastly improved.

Phacoemulsification is the most commonly performed outpatient surgery in the US; about 3 million cases are performed annually. Due to the high volume of cases, adverse events (AEs) are not uncommon. The incidence of complications following phacoemulsification is < 5%; the frequency of severe complications has been estimated at < 0.7%.⁸ Severe complications include endophthalmitis, suprachoroidal hemorrhage, and/or retinal detachment.⁹ Studies have shown a decline in rates of sight-threatening AEs from 1994 to 2006.⁹ A retrospective study of 45,082 veterans from 2005 to 2007 identified that a preoperative disease burden such as diabetes mellitus, chronic pulmonary disease, age-related macular degeneration, and diabetes with ophthalmic manifestations, was positively associated with a greater risk of cataract surgical complications.¹⁰

Complications

The level of a surgeon’s proficiency with phacoemulsification is directly correlated to the number of operations performed; there is a lower complication rate among more experienced surgeons, including those who work in high-volume settings.^11,12 One study identified that the AE rate within 14 days of surgery was 0.8% for surgeons performing 50 to 250 cataract surgeries per year, but only 0.1% for those performing > 1000 cataract surgeries annually.¹²

Potential postoperative lens exchange complications include increased IOP, corneal wound leakage, corneal edema, bullous keratopathy, cystoid macular edema, retinal detachment, and endophthalmitis (Table 1). A corneal wound leak can provide a potential ingress for bacteria, putting the patient at risk for endophthalmitis, perhaps the most devastating complication following cataract surgery.

Endophthalmitis

Endophthalmitis has been reported to occur in .001% to .327% of patients during postoperative care.^5,13-17 Early detection is important to maintain corneal integrity and prevent a cascade of detrimental ocular sequalae including the potential for endophthalmitis. According to Zaida and colleagues, endophthalmitis occurred in fewer than 1 of 1000 consecutive cases.¹⁴ A leaking clear corneal incision wound on the first day postoperatively has been associated with a 44-fold increased risk of endophthalmitis.¹³

Causes of endophthalmitis

In a retrospective case-controlled series of 57 patients with postcataract endophthalmitis, implantation of an intraocular lens with a resultant wound abnormality was thought to be the causative factor in 5%.¹⁷ Another source of endophthalmitis can be the intraocular lens (IOL), which may act as a vector for bacteria. By placing the IOL against the conjunctiva or exposing it to the theater air during surgery, bacteria can be introduced prior to implantation.¹⁷ Immunosuppressive treatment is the only patient antecedent factor that can be considered a predictor for endopthalmitis.¹⁷

The internal corneal seal is IOP dependent, and postoperative ocular hypotony may cause a seemingly watertight wound to leak. Taban and colleagues used anterior segment OCT to image numerous self-sealing incisions. They found that the corneal incision wound more tightly seals at higher IOPs. Additionally, more perpendicular (larger angle) incisions seal better at a lower IOP while less perpendicular (smaller angle) incisions seal better at a higher IOP (Figure 6).¹⁸

Incision Placement

Studies have shown that the main incision site is more clinically competent than is the side port incision site, as in our case study.¹⁹ Side-port incisions have a 1- or 2-plane architectural profile in contrast to the 3-plane profile typical of a main incision.¹⁹ Recent advances including the conversion to clear-corneal incisions of diminishing size, techniques used for wound construction, phacoemulsification machine design, and small-incision IOLs, should further reduce the prevalence and complications of wound compromise.²⁰

Seidel Testing

Seidel testing is the most common method to evaluate corneal wound integrity and identify leaks. A drop of topical anesthetic is instilled in the eye and then a fluorescein strip (not fluorescein sodium and benoxinate hydrochloride ophthalmic solution, which may become less sterile since it has a multiuse container) is applied to the superior conjunctiva. The clinician then looks for evidence of fluid egress using the cobalt blue filter. The patient is instructed to blink once. Fluid egress appears as a black stream as the fluorescein dye becomes diluted by aqueous humor escaping the nonintact wound and the appearance of bright green dye surrounds the leak site. The term Seidel positive indicates a leak. An estimate should be made of the rate and volume of fluid exiting the wound.

Gonioscopy

Gonioscopy can be used to evaluate the postsurgical incision, more specifically for identification and management of internal incision wound gape. On gonioscopy, internal wound gape appears as an elongated oval opening resembling a fish mouth. If internal incision wound gape is identified gonioscopically before surgery is complete, the leak can be managed intraoperatively. The surgeon can irrigate along the length of the incision to remove cortical fragments or viscoelastic that may cause internal wound gaping. If unsuccessful, rapidly deepening the anterior chamber with balanced salt solution through the paracentesis incision may be employed. These methods may improve wound stability, reduce risk of postoperative hyphema, lower the incidence of endophthalmitis, and lessen the likelihood of late against-the-rule drift.²¹

Anterior Segment Optical Coherence Tomography

Instances when Seidel testing was negative despite actual wound gaping have been described.^22,23 Anterior segment OCT is useful to evaluate incision architecture. A 2007 United Kingdom study investigated the corneal architecture in the immediate postoperative period following phacoemulsification using anterior segment OCT. This study showed the benefits of identifying architectural features such as epithelial gaping, endothelial gaping, stripping of Descemet membrane, and loss of coaptation. These features were found to be more common at low IOP and could represent a significant risk factor for endophthalmitis.²⁴ Another study published by Behrens and colleagues indicated that a localized detachment of Descemet membrane may be more common than observed with slit-lamp (Figure 7). Corneal gaping, especially if along the entire length of the surgical wound, may lead to inadvertent bacterial access into the anterior chamber.²⁵ 

Anterior segment OCT imaging was first described by Izatt and colleagues in 1994.²⁶ Unlike posterior segment OCT, anterior segment OCT requires a greater depth of field and higher energy levels as images are commonly distorted by refraction at boundaries where the refractive index changes. Longer infrared wavelengths improve the penetration through tissues that scatter light, such as the sclera and limbus, which allows visualization, for example, of the iridocorneal angle.^27,28

Two main scan patterns are used for anterior segment OCT: 512 x 128 cube scan (4-mm width x 4-mm length) and 5-line raster (3-mm length) with adjustable rotation and spacing. A recent software update allows measurement of corneal thickness, visualization of anterior chamber angle structures along with topographic analysis, anterior and posterior elevation maps of the cornea, and reliable pachymetric maps.^29,30 The anterior segment cube acquires a series of 128 horizontal scan lines each composed of 512 A-scans. These high-definition scans acquire vertical and horizontal directions composed of 1024 A-scans each. This cube may be used to measure corneal thickness and visualize corneal architecture, creating a 3-D image of the data (Figure 8). The anterior segment 5-line raster scans through 5 parallel lines of equal length to view high-resolution images of the anterior chamber angle and cornea. Each line, fixed at 3-mm in length, is composed of 4096 A-scans.³¹ Anterior segment cube OCT allows identification of subtle variations in incision architecture at different locations across the width of the OCT image.

Bandage Soft Contact Lens

Upon reviewing the anterior segment OCT images of our patient with the bandage contact lens in place, it was evident that the adherent ocular bandage was protecting the incision. A tighter fitting bandage contact lens is ideal and adheres firmly to any area of epithelial damage and epithelial gaping to help seal the incision, protecting the wound and improving structural integrity. The bandage contact lens is gradually replaced by new cells via re-epithelialization; thus, it behaves as an adjunct to natural wound healing. A bandage contact lens also improves patient comfort.

It is hypothesized that a bandage contact lens improves the structural integrity of the incision site and helps prevent leaking, hypotony, and minor wound leaks. One study revealed a statistically significant lower IOP in nonbandage contact lens patients by an average of 6 mm Hg (mean [SD] 13.4 mm Hg [5.3]; range, 5 - 23 mm Hg) vs patients with a bandage contact lens (mean [SD] 19.4 mm Hg [5.9]; range, 11 - 29 mm Hg) in the immediate postoperative period.³² The authors suggested that the bandage contact lens may prevent microleaks, resulting in a higher IOP.

Aqueous Suppressants

Aqueous suppressants are a great option when IOP is abnormally elevated by decreasing the IOP and allowing the cornea to heal and self-seal.Effective aqueous suppressants are β blockers and carbonic anhydrase inhibitors.

After phacoemulsification ocular hypotony (< 6 mm Hg) occurs most commonly due to wound leakage or excessive intraocular inflammation. However, with the presence of corneal wound leakage and ocular hypotony, aqueous suppressants are not the best option.

Further Management of Wound Leaks

Management of a postoperative wound leak will vary based on severity. The majority of mild leaks are self-sealing. Anterior segment OCT helps the clinician to identify microleaks in an otherwise Seidel negative eye. If wound leakage is moderate with a formed anterior chamber, the use of a bandage contact lens is a good option, as can be the prescription of aqueous suppressants, depending on IOP.³³

If the anterior chamber is flat, iris prolapse is apparent, or extremely low IOP exists, the patient needs to be referred to the surgeon. Current standard of care directs the surgeon to use sutures to further manage corneal wound leak. However, several studies have recognized the increased risk of suture-related complications, such as induced astigmatism, corneal opacities, incomplete wound closure, and corneal neovascularization.^6,34-38 Other wound closure options include polyethylene glycol-based products, corneal welding, cyanoacrylate, or fibrin (Table 2).³⁹ Traditionally nylon sutures have been used for clear corneal incision wound closure. However, tissue adhesives are gaining popularity as a substitute for sutures in wound closure.⁴⁰

Cyanoacrylate

Numerous studies have been published on the efficacy of cyanoacrylate as a substitute for sutures, specifically in clear corneal incisions. AEs of cyanoacrylate include a transient foreign-body sensation and diffuse or focal bulbar conjunctival hyperemia.^41,42 Shigemitsu and Majima found that fibrin and cyanoacrylate glue had tensile strength similar to sutures when used in cataract surgery.39 
Polyethylene glycol-based products, also used in artificial tears and contact lens materials, may also help seal wound leaks. Another agent is ReSure (Ocular Therapeutix, Bedford, MA), an FDA-approved synthetic, polyethylene glycol hydrogel sealant that is 90% water after polymerization. ReSure has been shown to be safe and effective in sealing cataract surgical clear corneal incisions.^6,43 ReSure takes about 20 seconds to prepare, and placement is aided by the use of a blue dye that dissipates within hours. This hydrogel will gradually slough off in the tears once the tissue has fully regenerated; there is no need to remove the sealant.⁴⁴

Rossi and colleagues evaluated the efficacy of corneal welding to close wounds after cataract surgery. The technique involves laser-assisted closure of the corneal wound(s) by a diode laser that welds the stroma.⁴⁵ Corneal welding takes seconds to achieve good closure without significant astigmatism or inflammation; however very careful application of the light absorbing dyes is required as they are toxic if allowed to enter the anterior chamber.^45-47

Conclusion

Optometrists may be called to manage patients during both the preoperative and postoperative phases of cataract surgical care. Those who participate in postoperative care should carefully evaluate for the presence of wound leak or wound gape as a potential complication. The OCT may be employed to evaluate patients suspected of having these leaks or gapes. Proficiency in the interpretation of OCT results and more traditional evaluation methods allows for successful detection of wound leaks or gapes. The timely diagnosis and treatment of postoperative wound leaks allow for the best possible outcomes for cataract surgery patients.

Lori J. Heim, MD, FAAFP, a hospitalist in practice at Scotland Memorial Hospital in Laurinburg, N.C., for the past 10 years, recalls when she first decided to pursue hospital medicine as a career. As a family physician in private practice who admitted patients to the local hospital in Pinehurst, N.C., and even followed them into the ICU, she needed a more flexible schedule when she became president-elect of the American Academy of Family Physicians (AAFP).

“My local hospital told me they had a policy against hiring family physicians as hospitalists. They didn’t consider us qualified,” Dr. Heim said. “I was incredulous when I first heard that because I already had full admitting privileges at the hospital. It made no sense, since they allowed me to manage my patients in the ICU.”

Then an opportunity opened at Scotland Memorial, located an hour away. “That has been a fabulous experience for me,” she said. The transition was relatively easy, following more than 2 decades of office practice. Dr. Heim’s hospitalist group now includes eight full-time clinicians who have a mix of family medicine and internal medicine backgrounds.

“I’ve never felt anything other than collegial support here. We go to the ER to evaluate patients and decide whether to admit them, and we do a lot of medical procedures. I’m not practicing pediatrics currently, but I have no problem conducting a gynecological exam. I think my experience in family medicine and primary care has been an asset,” Dr. Heim said. “I’m not sure I would be a hospitalist today if I had not been elected president of AAFP, but it was fortuitous.”

Respect for HTFMs is growing

Hospitalists trained in family medicine (HTFM) are a small but important segment of this field and of the membership of the Society of Hospital Medicine. The board specialties of physicians who work in the hospital are not always broken out in existing databases, but HTFMs are believed to represent about 8% of SHM members, and somewhere around 10%-15% of the total hospitalist workforce. According to SHM’s 2018 State of Hospital Medicine Report, 65% of hospital medicine groups employed at least one family medicine–trained provider in their group.¹

SHM’s Special Interest Group (SIG) for HTFMs reports to the society’s Board of Directors. The American Academy of Family Medicine, with 131,400 members, also has a Member Interest Group (MIG) for HTFMs. When AAFP recently surveyed its members to identify their primary patient care practice location, only 4% named the hospital (not including the emergency department), while 3% said the hospital emergency department.²

Among 32,450 adult primary care-trained hospitalists surveyed for the June 2016 AAMC In Brief of the American Association of Medical Colleges, 81.9% of the hospitalists identified internal medicine as their specialty, while 5.2% identified themselves as family physicians.³ A 2014 Medical Group Management Association survey, which reported data for 4,200 hospitalists working in community hospitals, found that 82% were internal medicine trained, versus 10% in family medicine and 7% in pediatrics.

Family medicine hospitalists may be more common in rural areas or in small hospitals – where a clinician is often expected to wear more hats, said hospitalist David Goldstein, MD, FHM, assistant director of the family medicine residency program at Natividad Medical Center, Salinas, Calif., and cochair of SHM’s family medicine SIG. “In a smaller hospital, if there’s not sufficient volume to support full-time pediatric and adult hospital medicine services, a family medicine hospitalist might do both – and even help staff the ICU.”

A decade or so ago, much of the professional literature about the role of HTFMs suggested that some had experienced a lack of respect or of equal job opportunities, while others faced pay differentials.^3-5 Since then, the field of hospital medicine has come a long way toward recognizing their contributions, although there are still hurdles to overcome, mainly involving issues of credentialing, to allow HTFMs to play equal roles in the hospital, the ICU, or in residency training. The SHM 2018 State of Hospital Medicine Report reveals that HTFMs actually made slightly higher salaries on average than their internist colleagues, $301,833 versus $300,030.

Prior to the advent of hospital medicine, both family medicine and internal medicine physicians practiced in much the same way in their medical offices, and visited their patients in the hospital, said Claudia Geyer, MD, SFHM, system chief of hospital medicine at Central Maine Healthcare in Lewiston. She is trained and boarded in both family and internal medicine. “When hospital medicine launched, its heavy academic emphasis on internists led to underrecognition of the continued contributions of family medicine. Family physicians never left the hospital setting and – in certain locales – were the predominant hospitalists. We just waited for the recognition to catch up with the reality,” Dr. Geyer said.

“I don’t feel family medicine for hospitalists is nearly the stepchild of internal medicine that it was when I first started,” Dr. Heim said. “In my multihospital hospitalist group, I haven’t seen anything to suggest that they treat family medicine hospitalists as second class.” The demand for hospitalists is greater than internists can fill, while clearly the public is not concerned about these distinctions, she said.

Whether clinicians are board certified in family medicine or internal medicine may be less important to their skills for practicing in the hospital than which residency program they completed, what emphasis it placed on working in the hospital or ICU, electives completed, and other past experience. “Some family medicine residencies offer more or less hospital experience,” Dr. Heim said.

Jasen Gundersen, MD, MBA, CPE, SFHM, president of acute and post-acute services for the national hospital services company TeamHealth, agreed that there has been dramatic improvement in the status of HTFMs. He is one, and still practices as a hospitalist at Boca Raton (Fla.) Regional Hospital when administrative responsibilities permit.

TeamHealth has long been open to family medicine doctors, Dr. Gundersen added, although some of the medical staff at hospitals that contract with TeamHealth have issues with it. “We will talk to them about it,” he said. “We hire hospitalists who can do the work, and we evaluate them based on their background and skill set, where they’ve practiced and for how long. We want people who are experienced and good at managing hospitalized patients. For new residency grads, we look at their electives and the focus of their training.”

What is home for HTFMs?

Where are HTFMs most likely to find their professional home? “That’s hard to answer,” said Patricia Seymour, MD, FHM, FAAFP, an academic hospitalist at the University of Massachusetts-Worcester. “In the last 4-5 years, SHM has worked very hard to create a space for HTFMs. AAFP has a hospital medicine track at their annual meeting, and that’s a good thing. But they also need to protect family physicians’ right to practice in any setting they choose. For those pursuing hospital medicine, there’s a different career trajectory, different CME needs, and different recertification needs.”

Dr. Seymour is the executive cochair of SHM’s family medicine SIG and serves as interim chief of a family medicine hospitalist group that provides inpatient training for a family practice residency, where up to a third of the 12 residents each year go on to pursue hospital medicine as a career. “We have the second-oldest family medicine–specific hospitalist group in the country, so our residency training has an emphasis on hospital medicine,” she explained.

“Because I’m a practicing hospitalist, the residents come to me seeking advice. I appreciate the training I received as a family physician in communication science, palliative care, geriatrics, family systems theory, and public health. I wouldn’t have done it any other way, and that’s how I counsel our students and residents,” she said. Others suggest that the generalist training and diverse experiences of family medicine can be a gift for a doctor who later chooses hospital medicine.

AAFP is a large umbrella organization and the majority of its members practice primary care, Dr. Heim said. “I don’t know the percentage of HTFMs who are members of AAFP. Some no doubt belong to both AAFP and SHM.” Even though both groups have recognized this important subset of their members who chose the field of hospital medicine and its status as a career track, it can be a stretch for family medicine to embrace hospitalists.

“It inherently goes against our training, which is to work in outpatient, inpatient, obstetric, pediatric, and adult settings,” Dr. Heim said. “It’s difficult to reconcile giving up a big part of what defined your training – that range of settings. I remember feeling like I should apologize to other family medicine doctors for choosing this path.”

Credentialing opportunities and barriers

For the diverse group of practicing HTFMs, credentialing and scope of practice represent their biggest current issues. A designation of Focused Practice in Hospital Medicine (FPHM) has been offered jointly since 2010 by the American Board of Family Medicine (ABFM) and the American Board of Internal Medicine (ABIM), although their specific requirements vary.

Eligible hospitalist candidates for the focused practice exam must have an unrestricted medical license, maintenance of current primary certification, and verification of three years of unsupervised hospital medicine practice experience. ABIM views FPHM not as a subspecialty, but as a variation of internal medicine certification, identifying diplomates who are board-certified in internal medicine with a hospital medicine specialization. They do not have to take the general internal medicine recertification exam if they qualify for FPHM.

ABFM-certified family physicians who work primarily in a hospital setting can take the same test for FPHM, with the same eligibility requirements. But ABFM does not consider focused practice a subspecialty, or the Certificate of Added Qualifications in Family Medicine as sufficient for board certification. That means family physicians also need to take its general board exam in order to maintain their ABFM board certification.

ABFM’s decision not to accept the focused practice designation as sufficient for boarding was disappointing to a lot of hospitalists, said Laura “Nell” Hodo, MD, FAAFP, chair of AAFP’s hospital medicine MIG, and a pediatric academic hospitalist at Icahn School of Medicine at Mount Sinai, New York. “Many family physicians practice hospital medicine exclusively and would prefer to take one boarding exam instead of two, and not have to do CME and board review in areas where we don’t practice anymore,” Dr. Hodo said, adding that she hopes that this decision could be revisited in the future.

A number of 1-year hospital medicine fellowships across the country provide additional training opportunities for both family practice and internal medicine residency graduates. These fellowships do not offer board certification or designated specialty credentialing for hospitalists and are not recognized by the American College of Graduate Medical Education (ACGME), which sets standards for residency and fellowship training. “But they reflect a need and an interest in optimizing the knowledge of hospital medicine and developing the specific skills needed to practice it well,” Dr. Geyer noted.

She directs a program for one to three fellows per year out of the Central Maine Family Medicine Residency program and Central Maine Medical Center in Lewiston, and is now recruiting her tenth class. At least 13 other hospital medicine fellowships, out of about 40 nationwide, are family medicine based. “We rely heavily on the Core Competencies in Hospital Medicine developed by SHM, which emphasize clinical conditions, medical procedures, and health care systems. Gaining fluency in the latter is really what makes hospital medicine unique,” Dr. Geyer said.

Often residency graduates seeking work in hospital medicine are insufficiently prepared for hospital billing and coding, enacting safe transitions of care, providing palliative care, and understanding how to impact their health care systems for quality improvement, patient safety and the like, she added.

Dr. Geyer said her fellowship does not mean just being a poorly paid hospitalist for a year. “The fellows are clearly trainees, getting the full benefit of our supervision and supplemental training focused on enhanced clinical and procedural exposure, but also on academics, quality improvement, leadership, and efficiency,” she said. “All of our fellows join SHM, go to the Annual Conference, propose case studies, do longitudinal quality or safety projects, and learn the other aspects of hospital medicine not well-taught in residency. We train them to be highly functional hospitalists right out of the gate.”

Until recently, another barrier for HTFMs was their ability to be on the faculty of internal medicine residency programs. Previous language from ACGME indicated that family medicine-trained physicians could not serve as faculty for these programs, Dr. Goldstein said. SHM has lobbied ACGME to change that rule, which could enable family medicine hospitalists who had achieved FPHM designation to be attendings and to teach internal medicine residents.
 

Needed in critical care – but not credentialed

One of the biggest frustrations for family medicine hospitalists is clarifying their role in the ICU. SHM’s Education Committee recently surveyed hospitalist members who practice in the ICU, finding that at least half felt obliged to practice beyond their scope, 90 percent occasionally perceived insufficient support from intensivists, and two-thirds reported moderate difficulty transferring patients to higher levels of intensive care.⁷ The respondents overwhelmingly indicated that they wanted more training and education in critical care medicine.

“I want to highlight the fact that in some settings family physicians are the sole providers of critical care,” Dr. Goldstein said. Meanwhile, the standards of the Leapfrog Group, a coalition of health care purchasers, call for ICUs to be staffed by physicians certified in critical care, even though there is a growing shortage of credentialed intensivists to treat an increasing number of older, sicker, critically ill patients.

Some internal medicine physicians don’t want to have anything to do with the ICU because of the medical and legal risks, said David Aymond, MD, a family physician and hospitalist at Byrd Regional Hospital in Leesville, La. “There’s a bunch of sick people in the ICU, and when some doctors like me started doing critical care, we realized we liked it. Depending on your locale, if you are doing hospital medicine, critically ill patients are going to fall in your lap,” he said. “But if you don’t have the skills, that could lead to poor outcomes and unnecessary transfers.”

Dr. Aymond started his career in family medicine. “When I got into residency, I saw how much critical care was needed in rural communities. I decided I would learn everything I could about it. I did a hospital medicine fellowship at the University of Alabama, which included considerable involvement in the ICU. When I went to Byrd Regional, a 60-bed facility with eight ICU beds, we did all of the critical care, and word started to spread in the community. My hospitalist partner and I are now on call 24/7 alternating weeks, doing the majority of the critical care and taking care of anything that goes on in an ICU at a larger center, although we often lack access to consultation services,” he explained.

“We needed to get the attention of the Society of Critical Care Medicine (SCCM) to communicate the scope of this problem. These doctors are doing critical care but there is no official medical training or recognition for them. So they’re legally out on a limb, even though often they are literally the only person available to do it,” Dr. Aymond said. “Certainly there’s a skills gap between HTFMs and board-certified intensivists, but some of that gap has to do with the volume of patients they have seen in the ICU and their comfort level,” he said.

SHM is pursuing initiatives to help address this gap, including collaborating with SCCM on developing a rigorous critical care training curriculum for internal medicine and family medicine hospitalists, with coursework drawn from existing sources, said Eric Siegal, MD, SFHM, a critical care physician in Milwaukee. “It doesn’t replace a 2-year critical care fellowship, but it will be a lot more than what’s currently out there for the nonintensivist who practices in the ICU.” SCCM has approved moving forward with the advanced training curriculum, he said.

Another priority is to try to create a pathway that could permit family medicine–trained hospitalists to apply for existing critical care fellowships, as internal medicine doctors are now able to do. SHM has lobbied ABFM to create a pathway to subspecialty certification in critical care medicine, similar to those that exist for internists and emergency physicians, Dr. Goldstein said, adding that ACGME, which controls access to fellowships, will be the next step. Dr. Aymond expects that there will be a lot of hoops to jump through.

“David Aymond is an exceptional hospitalist,” Dr. Siegal added. “He thinks and talks like an intensivist, but it took concerted and self-directed effort for him to get there. Family practitioners are a significant part of the rural critical care workforce, but their training generally does not adequately prepare them for this role – unless they have made a conscious effort to pursue additional training,” he said.

“My message to family practitioners is not that they’re not good enough to do this, but rather that they are being asked to do something they weren’t trained for. How can we help them do it well?”

References

1. Society of Hospital Medicine (SHM) Practice Analysis Committee. 2018 State of Hospital Medicine Report; Oct 2018.

2. American Academy of Family Physicians Member Census, Dec 31, 2017.

3. Jones KC et al. Hospitalists: A growing part of the primary care workforce. AAMC Analysis in Brief; June 2016; 16(5):1.

4. Berczuk C. Uniquely positioned. The Hospitalist; July 2009.

5. Iqbal Y. Family medicine hospitalists: Separate and unequal? Today’s Hospitalist; May 2007.

6. Kinnan JP. The family way. The Hospitalist; Nov 2007.

7. Sweigart JR et al. Characterizing hospitalist practice and perceptions of critical care delivery. J Hosp Med. 2018 Jan 1;13(1):6-12.

Lori J. Heim, MD, FAAFP, a hospitalist in practice at Scotland Memorial Hospital in Laurinburg, N.C., for the past 10 years, recalls when she first decided to pursue hospital medicine as a career. As a family physician in private practice who admitted patients to the local hospital in Pinehurst, N.C., and even followed them into the ICU, she needed a more flexible schedule when she became president-elect of the American Academy of Family Physicians (AAFP).

“My local hospital told me they had a policy against hiring family physicians as hospitalists. They didn’t consider us qualified,” Dr. Heim said. “I was incredulous when I first heard that because I already had full admitting privileges at the hospital. It made no sense, since they allowed me to manage my patients in the ICU.”

Then an opportunity opened at Scotland Memorial, located an hour away. “That has been a fabulous experience for me,” she said. The transition was relatively easy, following more than 2 decades of office practice. Dr. Heim’s hospitalist group now includes eight full-time clinicians who have a mix of family medicine and internal medicine backgrounds.

“I’ve never felt anything other than collegial support here. We go to the ER to evaluate patients and decide whether to admit them, and we do a lot of medical procedures. I’m not practicing pediatrics currently, but I have no problem conducting a gynecological exam. I think my experience in family medicine and primary care has been an asset,” Dr. Heim said. “I’m not sure I would be a hospitalist today if I had not been elected president of AAFP, but it was fortuitous.”

Respect for HTFMs is growing

Hospitalists trained in family medicine (HTFM) are a small but important segment of this field and of the membership of the Society of Hospital Medicine. The board specialties of physicians who work in the hospital are not always broken out in existing databases, but HTFMs are believed to represent about 8% of SHM members, and somewhere around 10%-15% of the total hospitalist workforce. According to SHM’s 2018 State of Hospital Medicine Report, 65% of hospital medicine groups employed at least one family medicine–trained provider in their group.¹

SHM’s Special Interest Group (SIG) for HTFMs reports to the society’s Board of Directors. The American Academy of Family Medicine, with 131,400 members, also has a Member Interest Group (MIG) for HTFMs. When AAFP recently surveyed its members to identify their primary patient care practice location, only 4% named the hospital (not including the emergency department), while 3% said the hospital emergency department.²

Among 32,450 adult primary care-trained hospitalists surveyed for the June 2016 AAMC In Brief of the American Association of Medical Colleges, 81.9% of the hospitalists identified internal medicine as their specialty, while 5.2% identified themselves as family physicians.³ A 2014 Medical Group Management Association survey, which reported data for 4,200 hospitalists working in community hospitals, found that 82% were internal medicine trained, versus 10% in family medicine and 7% in pediatrics.

Family medicine hospitalists may be more common in rural areas or in small hospitals – where a clinician is often expected to wear more hats, said hospitalist David Goldstein, MD, FHM, assistant director of the family medicine residency program at Natividad Medical Center, Salinas, Calif., and cochair of SHM’s family medicine SIG. “In a smaller hospital, if there’s not sufficient volume to support full-time pediatric and adult hospital medicine services, a family medicine hospitalist might do both – and even help staff the ICU.”

A decade or so ago, much of the professional literature about the role of HTFMs suggested that some had experienced a lack of respect or of equal job opportunities, while others faced pay differentials.^3-5 Since then, the field of hospital medicine has come a long way toward recognizing their contributions, although there are still hurdles to overcome, mainly involving issues of credentialing, to allow HTFMs to play equal roles in the hospital, the ICU, or in residency training. The SHM 2018 State of Hospital Medicine Report reveals that HTFMs actually made slightly higher salaries on average than their internist colleagues, $301,833 versus $300,030.

Prior to the advent of hospital medicine, both family medicine and internal medicine physicians practiced in much the same way in their medical offices, and visited their patients in the hospital, said Claudia Geyer, MD, SFHM, system chief of hospital medicine at Central Maine Healthcare in Lewiston. She is trained and boarded in both family and internal medicine. “When hospital medicine launched, its heavy academic emphasis on internists led to underrecognition of the continued contributions of family medicine. Family physicians never left the hospital setting and – in certain locales – were the predominant hospitalists. We just waited for the recognition to catch up with the reality,” Dr. Geyer said.

“I don’t feel family medicine for hospitalists is nearly the stepchild of internal medicine that it was when I first started,” Dr. Heim said. “In my multihospital hospitalist group, I haven’t seen anything to suggest that they treat family medicine hospitalists as second class.” The demand for hospitalists is greater than internists can fill, while clearly the public is not concerned about these distinctions, she said.

Whether clinicians are board certified in family medicine or internal medicine may be less important to their skills for practicing in the hospital than which residency program they completed, what emphasis it placed on working in the hospital or ICU, electives completed, and other past experience. “Some family medicine residencies offer more or less hospital experience,” Dr. Heim said.

Jasen Gundersen, MD, MBA, CPE, SFHM, president of acute and post-acute services for the national hospital services company TeamHealth, agreed that there has been dramatic improvement in the status of HTFMs. He is one, and still practices as a hospitalist at Boca Raton (Fla.) Regional Hospital when administrative responsibilities permit.

TeamHealth has long been open to family medicine doctors, Dr. Gundersen added, although some of the medical staff at hospitals that contract with TeamHealth have issues with it. “We will talk to them about it,” he said. “We hire hospitalists who can do the work, and we evaluate them based on their background and skill set, where they’ve practiced and for how long. We want people who are experienced and good at managing hospitalized patients. For new residency grads, we look at their electives and the focus of their training.”

What is home for HTFMs?

Where are HTFMs most likely to find their professional home? “That’s hard to answer,” said Patricia Seymour, MD, FHM, FAAFP, an academic hospitalist at the University of Massachusetts-Worcester. “In the last 4-5 years, SHM has worked very hard to create a space for HTFMs. AAFP has a hospital medicine track at their annual meeting, and that’s a good thing. But they also need to protect family physicians’ right to practice in any setting they choose. For those pursuing hospital medicine, there’s a different career trajectory, different CME needs, and different recertification needs.”

Dr. Seymour is the executive cochair of SHM’s family medicine SIG and serves as interim chief of a family medicine hospitalist group that provides inpatient training for a family practice residency, where up to a third of the 12 residents each year go on to pursue hospital medicine as a career. “We have the second-oldest family medicine–specific hospitalist group in the country, so our residency training has an emphasis on hospital medicine,” she explained.

“Because I’m a practicing hospitalist, the residents come to me seeking advice. I appreciate the training I received as a family physician in communication science, palliative care, geriatrics, family systems theory, and public health. I wouldn’t have done it any other way, and that’s how I counsel our students and residents,” she said. Others suggest that the generalist training and diverse experiences of family medicine can be a gift for a doctor who later chooses hospital medicine.

AAFP is a large umbrella organization and the majority of its members practice primary care, Dr. Heim said. “I don’t know the percentage of HTFMs who are members of AAFP. Some no doubt belong to both AAFP and SHM.” Even though both groups have recognized this important subset of their members who chose the field of hospital medicine and its status as a career track, it can be a stretch for family medicine to embrace hospitalists.

“It inherently goes against our training, which is to work in outpatient, inpatient, obstetric, pediatric, and adult settings,” Dr. Heim said. “It’s difficult to reconcile giving up a big part of what defined your training – that range of settings. I remember feeling like I should apologize to other family medicine doctors for choosing this path.”

Credentialing opportunities and barriers

For the diverse group of practicing HTFMs, credentialing and scope of practice represent their biggest current issues. A designation of Focused Practice in Hospital Medicine (FPHM) has been offered jointly since 2010 by the American Board of Family Medicine (ABFM) and the American Board of Internal Medicine (ABIM), although their specific requirements vary.

Eligible hospitalist candidates for the focused practice exam must have an unrestricted medical license, maintenance of current primary certification, and verification of three years of unsupervised hospital medicine practice experience. ABIM views FPHM not as a subspecialty, but as a variation of internal medicine certification, identifying diplomates who are board-certified in internal medicine with a hospital medicine specialization. They do not have to take the general internal medicine recertification exam if they qualify for FPHM.

ABFM-certified family physicians who work primarily in a hospital setting can take the same test for FPHM, with the same eligibility requirements. But ABFM does not consider focused practice a subspecialty, or the Certificate of Added Qualifications in Family Medicine as sufficient for board certification. That means family physicians also need to take its general board exam in order to maintain their ABFM board certification.

ABFM’s decision not to accept the focused practice designation as sufficient for boarding was disappointing to a lot of hospitalists, said Laura “Nell” Hodo, MD, FAAFP, chair of AAFP’s hospital medicine MIG, and a pediatric academic hospitalist at Icahn School of Medicine at Mount Sinai, New York. “Many family physicians practice hospital medicine exclusively and would prefer to take one boarding exam instead of two, and not have to do CME and board review in areas where we don’t practice anymore,” Dr. Hodo said, adding that she hopes that this decision could be revisited in the future.

A number of 1-year hospital medicine fellowships across the country provide additional training opportunities for both family practice and internal medicine residency graduates. These fellowships do not offer board certification or designated specialty credentialing for hospitalists and are not recognized by the American College of Graduate Medical Education (ACGME), which sets standards for residency and fellowship training. “But they reflect a need and an interest in optimizing the knowledge of hospital medicine and developing the specific skills needed to practice it well,” Dr. Geyer noted.

She directs a program for one to three fellows per year out of the Central Maine Family Medicine Residency program and Central Maine Medical Center in Lewiston, and is now recruiting her tenth class. At least 13 other hospital medicine fellowships, out of about 40 nationwide, are family medicine based. “We rely heavily on the Core Competencies in Hospital Medicine developed by SHM, which emphasize clinical conditions, medical procedures, and health care systems. Gaining fluency in the latter is really what makes hospital medicine unique,” Dr. Geyer said.

Often residency graduates seeking work in hospital medicine are insufficiently prepared for hospital billing and coding, enacting safe transitions of care, providing palliative care, and understanding how to impact their health care systems for quality improvement, patient safety and the like, she added.

Dr. Geyer said her fellowship does not mean just being a poorly paid hospitalist for a year. “The fellows are clearly trainees, getting the full benefit of our supervision and supplemental training focused on enhanced clinical and procedural exposure, but also on academics, quality improvement, leadership, and efficiency,” she said. “All of our fellows join SHM, go to the Annual Conference, propose case studies, do longitudinal quality or safety projects, and learn the other aspects of hospital medicine not well-taught in residency. We train them to be highly functional hospitalists right out of the gate.”

Until recently, another barrier for HTFMs was their ability to be on the faculty of internal medicine residency programs. Previous language from ACGME indicated that family medicine-trained physicians could not serve as faculty for these programs, Dr. Goldstein said. SHM has lobbied ACGME to change that rule, which could enable family medicine hospitalists who had achieved FPHM designation to be attendings and to teach internal medicine residents.
 

Needed in critical care – but not credentialed

One of the biggest frustrations for family medicine hospitalists is clarifying their role in the ICU. SHM’s Education Committee recently surveyed hospitalist members who practice in the ICU, finding that at least half felt obliged to practice beyond their scope, 90 percent occasionally perceived insufficient support from intensivists, and two-thirds reported moderate difficulty transferring patients to higher levels of intensive care.⁷ The respondents overwhelmingly indicated that they wanted more training and education in critical care medicine.

“I want to highlight the fact that in some settings family physicians are the sole providers of critical care,” Dr. Goldstein said. Meanwhile, the standards of the Leapfrog Group, a coalition of health care purchasers, call for ICUs to be staffed by physicians certified in critical care, even though there is a growing shortage of credentialed intensivists to treat an increasing number of older, sicker, critically ill patients.

Some internal medicine physicians don’t want to have anything to do with the ICU because of the medical and legal risks, said David Aymond, MD, a family physician and hospitalist at Byrd Regional Hospital in Leesville, La. “There’s a bunch of sick people in the ICU, and when some doctors like me started doing critical care, we realized we liked it. Depending on your locale, if you are doing hospital medicine, critically ill patients are going to fall in your lap,” he said. “But if you don’t have the skills, that could lead to poor outcomes and unnecessary transfers.”

Dr. Aymond started his career in family medicine. “When I got into residency, I saw how much critical care was needed in rural communities. I decided I would learn everything I could about it. I did a hospital medicine fellowship at the University of Alabama, which included considerable involvement in the ICU. When I went to Byrd Regional, a 60-bed facility with eight ICU beds, we did all of the critical care, and word started to spread in the community. My hospitalist partner and I are now on call 24/7 alternating weeks, doing the majority of the critical care and taking care of anything that goes on in an ICU at a larger center, although we often lack access to consultation services,” he explained.

“We needed to get the attention of the Society of Critical Care Medicine (SCCM) to communicate the scope of this problem. These doctors are doing critical care but there is no official medical training or recognition for them. So they’re legally out on a limb, even though often they are literally the only person available to do it,” Dr. Aymond said. “Certainly there’s a skills gap between HTFMs and board-certified intensivists, but some of that gap has to do with the volume of patients they have seen in the ICU and their comfort level,” he said.

SHM is pursuing initiatives to help address this gap, including collaborating with SCCM on developing a rigorous critical care training curriculum for internal medicine and family medicine hospitalists, with coursework drawn from existing sources, said Eric Siegal, MD, SFHM, a critical care physician in Milwaukee. “It doesn’t replace a 2-year critical care fellowship, but it will be a lot more than what’s currently out there for the nonintensivist who practices in the ICU.” SCCM has approved moving forward with the advanced training curriculum, he said.

Another priority is to try to create a pathway that could permit family medicine–trained hospitalists to apply for existing critical care fellowships, as internal medicine doctors are now able to do. SHM has lobbied ABFM to create a pathway to subspecialty certification in critical care medicine, similar to those that exist for internists and emergency physicians, Dr. Goldstein said, adding that ACGME, which controls access to fellowships, will be the next step. Dr. Aymond expects that there will be a lot of hoops to jump through.

“David Aymond is an exceptional hospitalist,” Dr. Siegal added. “He thinks and talks like an intensivist, but it took concerted and self-directed effort for him to get there. Family practitioners are a significant part of the rural critical care workforce, but their training generally does not adequately prepare them for this role – unless they have made a conscious effort to pursue additional training,” he said.

“My message to family practitioners is not that they’re not good enough to do this, but rather that they are being asked to do something they weren’t trained for. How can we help them do it well?”

References

1. Society of Hospital Medicine (SHM) Practice Analysis Committee. 2018 State of Hospital Medicine Report; Oct 2018.

2. American Academy of Family Physicians Member Census, Dec 31, 2017.

3. Jones KC et al. Hospitalists: A growing part of the primary care workforce. AAMC Analysis in Brief; June 2016; 16(5):1.

4. Berczuk C. Uniquely positioned. The Hospitalist; July 2009.

5. Iqbal Y. Family medicine hospitalists: Separate and unequal? Today’s Hospitalist; May 2007.

6. Kinnan JP. The family way. The Hospitalist; Nov 2007.

7. Sweigart JR et al. Characterizing hospitalist practice and perceptions of critical care delivery. J Hosp Med. 2018 Jan 1;13(1):6-12.

Lori J. Heim, MD, FAAFP, a hospitalist in practice at Scotland Memorial Hospital in Laurinburg, N.C., for the past 10 years, recalls when she first decided to pursue hospital medicine as a career. As a family physician in private practice who admitted patients to the local hospital in Pinehurst, N.C., and even followed them into the ICU, she needed a more flexible schedule when she became president-elect of the American Academy of Family Physicians (AAFP).

“My local hospital told me they had a policy against hiring family physicians as hospitalists. They didn’t consider us qualified,” Dr. Heim said. “I was incredulous when I first heard that because I already had full admitting privileges at the hospital. It made no sense, since they allowed me to manage my patients in the ICU.”

Then an opportunity opened at Scotland Memorial, located an hour away. “That has been a fabulous experience for me,” she said. The transition was relatively easy, following more than 2 decades of office practice. Dr. Heim’s hospitalist group now includes eight full-time clinicians who have a mix of family medicine and internal medicine backgrounds.

“I’ve never felt anything other than collegial support here. We go to the ER to evaluate patients and decide whether to admit them, and we do a lot of medical procedures. I’m not practicing pediatrics currently, but I have no problem conducting a gynecological exam. I think my experience in family medicine and primary care has been an asset,” Dr. Heim said. “I’m not sure I would be a hospitalist today if I had not been elected president of AAFP, but it was fortuitous.”

Respect for HTFMs is growing

Hospitalists trained in family medicine (HTFM) are a small but important segment of this field and of the membership of the Society of Hospital Medicine. The board specialties of physicians who work in the hospital are not always broken out in existing databases, but HTFMs are believed to represent about 8% of SHM members, and somewhere around 10%-15% of the total hospitalist workforce. According to SHM’s 2018 State of Hospital Medicine Report, 65% of hospital medicine groups employed at least one family medicine–trained provider in their group.¹

SHM’s Special Interest Group (SIG) for HTFMs reports to the society’s Board of Directors. The American Academy of Family Medicine, with 131,400 members, also has a Member Interest Group (MIG) for HTFMs. When AAFP recently surveyed its members to identify their primary patient care practice location, only 4% named the hospital (not including the emergency department), while 3% said the hospital emergency department.²

Among 32,450 adult primary care-trained hospitalists surveyed for the June 2016 AAMC In Brief of the American Association of Medical Colleges, 81.9% of the hospitalists identified internal medicine as their specialty, while 5.2% identified themselves as family physicians.³ A 2014 Medical Group Management Association survey, which reported data for 4,200 hospitalists working in community hospitals, found that 82% were internal medicine trained, versus 10% in family medicine and 7% in pediatrics.

Family medicine hospitalists may be more common in rural areas or in small hospitals – where a clinician is often expected to wear more hats, said hospitalist David Goldstein, MD, FHM, assistant director of the family medicine residency program at Natividad Medical Center, Salinas, Calif., and cochair of SHM’s family medicine SIG. “In a smaller hospital, if there’s not sufficient volume to support full-time pediatric and adult hospital medicine services, a family medicine hospitalist might do both – and even help staff the ICU.”

A decade or so ago, much of the professional literature about the role of HTFMs suggested that some had experienced a lack of respect or of equal job opportunities, while others faced pay differentials.^3-5 Since then, the field of hospital medicine has come a long way toward recognizing their contributions, although there are still hurdles to overcome, mainly involving issues of credentialing, to allow HTFMs to play equal roles in the hospital, the ICU, or in residency training. The SHM 2018 State of Hospital Medicine Report reveals that HTFMs actually made slightly higher salaries on average than their internist colleagues, $301,833 versus $300,030.

Prior to the advent of hospital medicine, both family medicine and internal medicine physicians practiced in much the same way in their medical offices, and visited their patients in the hospital, said Claudia Geyer, MD, SFHM, system chief of hospital medicine at Central Maine Healthcare in Lewiston. She is trained and boarded in both family and internal medicine. “When hospital medicine launched, its heavy academic emphasis on internists led to underrecognition of the continued contributions of family medicine. Family physicians never left the hospital setting and – in certain locales – were the predominant hospitalists. We just waited for the recognition to catch up with the reality,” Dr. Geyer said.

“I don’t feel family medicine for hospitalists is nearly the stepchild of internal medicine that it was when I first started,” Dr. Heim said. “In my multihospital hospitalist group, I haven’t seen anything to suggest that they treat family medicine hospitalists as second class.” The demand for hospitalists is greater than internists can fill, while clearly the public is not concerned about these distinctions, she said.

Whether clinicians are board certified in family medicine or internal medicine may be less important to their skills for practicing in the hospital than which residency program they completed, what emphasis it placed on working in the hospital or ICU, electives completed, and other past experience. “Some family medicine residencies offer more or less hospital experience,” Dr. Heim said.

Jasen Gundersen, MD, MBA, CPE, SFHM, president of acute and post-acute services for the national hospital services company TeamHealth, agreed that there has been dramatic improvement in the status of HTFMs. He is one, and still practices as a hospitalist at Boca Raton (Fla.) Regional Hospital when administrative responsibilities permit.

TeamHealth has long been open to family medicine doctors, Dr. Gundersen added, although some of the medical staff at hospitals that contract with TeamHealth have issues with it. “We will talk to them about it,” he said. “We hire hospitalists who can do the work, and we evaluate them based on their background and skill set, where they’ve practiced and for how long. We want people who are experienced and good at managing hospitalized patients. For new residency grads, we look at their electives and the focus of their training.”

What is home for HTFMs?

Where are HTFMs most likely to find their professional home? “That’s hard to answer,” said Patricia Seymour, MD, FHM, FAAFP, an academic hospitalist at the University of Massachusetts-Worcester. “In the last 4-5 years, SHM has worked very hard to create a space for HTFMs. AAFP has a hospital medicine track at their annual meeting, and that’s a good thing. But they also need to protect family physicians’ right to practice in any setting they choose. For those pursuing hospital medicine, there’s a different career trajectory, different CME needs, and different recertification needs.”

Dr. Seymour is the executive cochair of SHM’s family medicine SIG and serves as interim chief of a family medicine hospitalist group that provides inpatient training for a family practice residency, where up to a third of the 12 residents each year go on to pursue hospital medicine as a career. “We have the second-oldest family medicine–specific hospitalist group in the country, so our residency training has an emphasis on hospital medicine,” she explained.

“Because I’m a practicing hospitalist, the residents come to me seeking advice. I appreciate the training I received as a family physician in communication science, palliative care, geriatrics, family systems theory, and public health. I wouldn’t have done it any other way, and that’s how I counsel our students and residents,” she said. Others suggest that the generalist training and diverse experiences of family medicine can be a gift for a doctor who later chooses hospital medicine.

AAFP is a large umbrella organization and the majority of its members practice primary care, Dr. Heim said. “I don’t know the percentage of HTFMs who are members of AAFP. Some no doubt belong to both AAFP and SHM.” Even though both groups have recognized this important subset of their members who chose the field of hospital medicine and its status as a career track, it can be a stretch for family medicine to embrace hospitalists.

“It inherently goes against our training, which is to work in outpatient, inpatient, obstetric, pediatric, and adult settings,” Dr. Heim said. “It’s difficult to reconcile giving up a big part of what defined your training – that range of settings. I remember feeling like I should apologize to other family medicine doctors for choosing this path.”

Credentialing opportunities and barriers

For the diverse group of practicing HTFMs, credentialing and scope of practice represent their biggest current issues. A designation of Focused Practice in Hospital Medicine (FPHM) has been offered jointly since 2010 by the American Board of Family Medicine (ABFM) and the American Board of Internal Medicine (ABIM), although their specific requirements vary.

Eligible hospitalist candidates for the focused practice exam must have an unrestricted medical license, maintenance of current primary certification, and verification of three years of unsupervised hospital medicine practice experience. ABIM views FPHM not as a subspecialty, but as a variation of internal medicine certification, identifying diplomates who are board-certified in internal medicine with a hospital medicine specialization. They do not have to take the general internal medicine recertification exam if they qualify for FPHM.

ABFM-certified family physicians who work primarily in a hospital setting can take the same test for FPHM, with the same eligibility requirements. But ABFM does not consider focused practice a subspecialty, or the Certificate of Added Qualifications in Family Medicine as sufficient for board certification. That means family physicians also need to take its general board exam in order to maintain their ABFM board certification.

ABFM’s decision not to accept the focused practice designation as sufficient for boarding was disappointing to a lot of hospitalists, said Laura “Nell” Hodo, MD, FAAFP, chair of AAFP’s hospital medicine MIG, and a pediatric academic hospitalist at Icahn School of Medicine at Mount Sinai, New York. “Many family physicians practice hospital medicine exclusively and would prefer to take one boarding exam instead of two, and not have to do CME and board review in areas where we don’t practice anymore,” Dr. Hodo said, adding that she hopes that this decision could be revisited in the future.

A number of 1-year hospital medicine fellowships across the country provide additional training opportunities for both family practice and internal medicine residency graduates. These fellowships do not offer board certification or designated specialty credentialing for hospitalists and are not recognized by the American College of Graduate Medical Education (ACGME), which sets standards for residency and fellowship training. “But they reflect a need and an interest in optimizing the knowledge of hospital medicine and developing the specific skills needed to practice it well,” Dr. Geyer noted.

She directs a program for one to three fellows per year out of the Central Maine Family Medicine Residency program and Central Maine Medical Center in Lewiston, and is now recruiting her tenth class. At least 13 other hospital medicine fellowships, out of about 40 nationwide, are family medicine based. “We rely heavily on the Core Competencies in Hospital Medicine developed by SHM, which emphasize clinical conditions, medical procedures, and health care systems. Gaining fluency in the latter is really what makes hospital medicine unique,” Dr. Geyer said.

Often residency graduates seeking work in hospital medicine are insufficiently prepared for hospital billing and coding, enacting safe transitions of care, providing palliative care, and understanding how to impact their health care systems for quality improvement, patient safety and the like, she added.

Dr. Geyer said her fellowship does not mean just being a poorly paid hospitalist for a year. “The fellows are clearly trainees, getting the full benefit of our supervision and supplemental training focused on enhanced clinical and procedural exposure, but also on academics, quality improvement, leadership, and efficiency,” she said. “All of our fellows join SHM, go to the Annual Conference, propose case studies, do longitudinal quality or safety projects, and learn the other aspects of hospital medicine not well-taught in residency. We train them to be highly functional hospitalists right out of the gate.”

Until recently, another barrier for HTFMs was their ability to be on the faculty of internal medicine residency programs. Previous language from ACGME indicated that family medicine-trained physicians could not serve as faculty for these programs, Dr. Goldstein said. SHM has lobbied ACGME to change that rule, which could enable family medicine hospitalists who had achieved FPHM designation to be attendings and to teach internal medicine residents.
 

Needed in critical care – but not credentialed

One of the biggest frustrations for family medicine hospitalists is clarifying their role in the ICU. SHM’s Education Committee recently surveyed hospitalist members who practice in the ICU, finding that at least half felt obliged to practice beyond their scope, 90 percent occasionally perceived insufficient support from intensivists, and two-thirds reported moderate difficulty transferring patients to higher levels of intensive care.⁷ The respondents overwhelmingly indicated that they wanted more training and education in critical care medicine.

“I want to highlight the fact that in some settings family physicians are the sole providers of critical care,” Dr. Goldstein said. Meanwhile, the standards of the Leapfrog Group, a coalition of health care purchasers, call for ICUs to be staffed by physicians certified in critical care, even though there is a growing shortage of credentialed intensivists to treat an increasing number of older, sicker, critically ill patients.

Some internal medicine physicians don’t want to have anything to do with the ICU because of the medical and legal risks, said David Aymond, MD, a family physician and hospitalist at Byrd Regional Hospital in Leesville, La. “There’s a bunch of sick people in the ICU, and when some doctors like me started doing critical care, we realized we liked it. Depending on your locale, if you are doing hospital medicine, critically ill patients are going to fall in your lap,” he said. “But if you don’t have the skills, that could lead to poor outcomes and unnecessary transfers.”

Dr. Aymond started his career in family medicine. “When I got into residency, I saw how much critical care was needed in rural communities. I decided I would learn everything I could about it. I did a hospital medicine fellowship at the University of Alabama, which included considerable involvement in the ICU. When I went to Byrd Regional, a 60-bed facility with eight ICU beds, we did all of the critical care, and word started to spread in the community. My hospitalist partner and I are now on call 24/7 alternating weeks, doing the majority of the critical care and taking care of anything that goes on in an ICU at a larger center, although we often lack access to consultation services,” he explained.

“We needed to get the attention of the Society of Critical Care Medicine (SCCM) to communicate the scope of this problem. These doctors are doing critical care but there is no official medical training or recognition for them. So they’re legally out on a limb, even though often they are literally the only person available to do it,” Dr. Aymond said. “Certainly there’s a skills gap between HTFMs and board-certified intensivists, but some of that gap has to do with the volume of patients they have seen in the ICU and their comfort level,” he said.

SHM is pursuing initiatives to help address this gap, including collaborating with SCCM on developing a rigorous critical care training curriculum for internal medicine and family medicine hospitalists, with coursework drawn from existing sources, said Eric Siegal, MD, SFHM, a critical care physician in Milwaukee. “It doesn’t replace a 2-year critical care fellowship, but it will be a lot more than what’s currently out there for the nonintensivist who practices in the ICU.” SCCM has approved moving forward with the advanced training curriculum, he said.

Another priority is to try to create a pathway that could permit family medicine–trained hospitalists to apply for existing critical care fellowships, as internal medicine doctors are now able to do. SHM has lobbied ABFM to create a pathway to subspecialty certification in critical care medicine, similar to those that exist for internists and emergency physicians, Dr. Goldstein said, adding that ACGME, which controls access to fellowships, will be the next step. Dr. Aymond expects that there will be a lot of hoops to jump through.

“David Aymond is an exceptional hospitalist,” Dr. Siegal added. “He thinks and talks like an intensivist, but it took concerted and self-directed effort for him to get there. Family practitioners are a significant part of the rural critical care workforce, but their training generally does not adequately prepare them for this role – unless they have made a conscious effort to pursue additional training,” he said.

“My message to family practitioners is not that they’re not good enough to do this, but rather that they are being asked to do something they weren’t trained for. How can we help them do it well?”

References

1. Society of Hospital Medicine (SHM) Practice Analysis Committee. 2018 State of Hospital Medicine Report; Oct 2018.

2. American Academy of Family Physicians Member Census, Dec 31, 2017.

3. Jones KC et al. Hospitalists: A growing part of the primary care workforce. AAMC Analysis in Brief; June 2016; 16(5):1.

4. Berczuk C. Uniquely positioned. The Hospitalist; July 2009.

5. Iqbal Y. Family medicine hospitalists: Separate and unequal? Today’s Hospitalist; May 2007.

6. Kinnan JP. The family way. The Hospitalist; Nov 2007.

7. Sweigart JR et al. Characterizing hospitalist practice and perceptions of critical care delivery. J Hosp Med. 2018 Jan 1;13(1):6-12.