Pityriasis rosea is a papulosquamous eruption that favors the trunk and proximal extremities. It occurs most commonly in adolescents and young adults.¹ The rash typically presents with a solitary lesion, known as a “herald patch,” which is followed by a scaly erythematous eruption along the cleavage lines of the skin. The condition is self-limited and often resolves in 6 to 8 weeks. Recent evidence suggests that viral reactivation of human herpesvirus 6 and human herpesvirus 7 may play a role in the development of skin lesions.² Pityriasis rosea also has been reported following the administration of new medications and vaccinations.^1-3 We report a case of a 30-year-old woman who developed pityriasis rosea 3 days after receiving the second dose of the COVID-19 vaccine.

Case Report

A 30-year-old woman presented to the dermatology office for evaluation of a rash on the trunk and upper extremities that had been present for 5 days. She reported an initial solitary lesion on the left upper back, subsequently followed by the appearance of a mildly pruritic rash on the trunk and upper extremities. The rash first appeared 3 days after she received the second dose of the Pfizer-BioNTech COVID-19 vaccine. She was otherwise asymptomatic after vaccination and denied fever, chills, headache, and myalgia. She denied any rash following her first dose of the COVID-19 vaccine, history of known COVID-19 infection or exposures, or new medications. Notably, the patient worked in health care.

Physical examination revealed a 2-cm, erythematous, thin, scaly plaque over the left side of the upper back (Figure, A). Erythematous, scaly, thin papules of varying sizes were distributed along the cleavage lines of the trunk and upper extremities (Figure, B). No biopsy was performed because of the classic clinical presentation of this self-limited condition and the patient’s history of hypertrophic scarring. No additional laboratory workup was performed. She was prescribed triamcinolone cream 0.1% as needed for pruritus and was reassured about the benign nature of this cutaneous eruption.

Comment

A broad spectrum of cutaneous manifestations has been reported in association with acute COVID-19 infection, including a papulovesicular rash, perniolike eruptions, urticaria, livedo reticularis, and petechiae.⁴ Several cases of pityriasis rosea in association with acute COVID-19 infection also have been reported.⁵ COVID-19 infection has been linked to reactivation of the herpesvirus, which may explain the connection between acute COVID-19 infection and the development of pityriasis rosea.⁶ Pityriasis rosea associated with administration of the COVID-19 vaccine is a rare complication with few reports in the literature.⁷ Similar to our patient, there are reports of pityriasis rosea developing after the second dose of the vaccine, with some patients reporting a reactivation of skin lesions.⁸ There is a paucity of reports describing pityriasis rosea associated with the influenza vaccine, hepatitis B vaccine, and human papillomavirus vaccine.³ In such cases, the onset of skin lesions was thought to be related to vaccine-induced stimulation of the immune system or a component of the vaccine.

Conclusion

We presented a unique case of pityriasis rosea following COVID-19 vaccination. Because additional laboratory workup and a skin biopsy were not performed, we are unable to infer causation. However, the classic clinical presentation, rash development within 3 days of vaccination, and prior reports of vaccine-associated pityriasis rosea strengthen the aforementioned association. We hope this case adds to the growing understanding of the novel COVID-19 vaccine. As more individuals become vaccinated, both clinicians and patients should be aware of this benign cutaneous eruption that can develop following COVID-19 vaccination.

Pityriasis rosea is a papulosquamous eruption that favors the trunk and proximal extremities. It occurs most commonly in adolescents and young adults.¹ The rash typically presents with a solitary lesion, known as a “herald patch,” which is followed by a scaly erythematous eruption along the cleavage lines of the skin. The condition is self-limited and often resolves in 6 to 8 weeks. Recent evidence suggests that viral reactivation of human herpesvirus 6 and human herpesvirus 7 may play a role in the development of skin lesions.² Pityriasis rosea also has been reported following the administration of new medications and vaccinations.^1-3 We report a case of a 30-year-old woman who developed pityriasis rosea 3 days after receiving the second dose of the COVID-19 vaccine.

Case Report

A 30-year-old woman presented to the dermatology office for evaluation of a rash on the trunk and upper extremities that had been present for 5 days. She reported an initial solitary lesion on the left upper back, subsequently followed by the appearance of a mildly pruritic rash on the trunk and upper extremities. The rash first appeared 3 days after she received the second dose of the Pfizer-BioNTech COVID-19 vaccine. She was otherwise asymptomatic after vaccination and denied fever, chills, headache, and myalgia. She denied any rash following her first dose of the COVID-19 vaccine, history of known COVID-19 infection or exposures, or new medications. Notably, the patient worked in health care.

Physical examination revealed a 2-cm, erythematous, thin, scaly plaque over the left side of the upper back (Figure, A). Erythematous, scaly, thin papules of varying sizes were distributed along the cleavage lines of the trunk and upper extremities (Figure, B). No biopsy was performed because of the classic clinical presentation of this self-limited condition and the patient’s history of hypertrophic scarring. No additional laboratory workup was performed. She was prescribed triamcinolone cream 0.1% as needed for pruritus and was reassured about the benign nature of this cutaneous eruption.

Comment

A broad spectrum of cutaneous manifestations has been reported in association with acute COVID-19 infection, including a papulovesicular rash, perniolike eruptions, urticaria, livedo reticularis, and petechiae.⁴ Several cases of pityriasis rosea in association with acute COVID-19 infection also have been reported.⁵ COVID-19 infection has been linked to reactivation of the herpesvirus, which may explain the connection between acute COVID-19 infection and the development of pityriasis rosea.⁶ Pityriasis rosea associated with administration of the COVID-19 vaccine is a rare complication with few reports in the literature.⁷ Similar to our patient, there are reports of pityriasis rosea developing after the second dose of the vaccine, with some patients reporting a reactivation of skin lesions.⁸ There is a paucity of reports describing pityriasis rosea associated with the influenza vaccine, hepatitis B vaccine, and human papillomavirus vaccine.³ In such cases, the onset of skin lesions was thought to be related to vaccine-induced stimulation of the immune system or a component of the vaccine.

Conclusion

We presented a unique case of pityriasis rosea following COVID-19 vaccination. Because additional laboratory workup and a skin biopsy were not performed, we are unable to infer causation. However, the classic clinical presentation, rash development within 3 days of vaccination, and prior reports of vaccine-associated pityriasis rosea strengthen the aforementioned association. We hope this case adds to the growing understanding of the novel COVID-19 vaccine. As more individuals become vaccinated, both clinicians and patients should be aware of this benign cutaneous eruption that can develop following COVID-19 vaccination.

Pityriasis rosea is a papulosquamous eruption that favors the trunk and proximal extremities. It occurs most commonly in adolescents and young adults.¹ The rash typically presents with a solitary lesion, known as a “herald patch,” which is followed by a scaly erythematous eruption along the cleavage lines of the skin. The condition is self-limited and often resolves in 6 to 8 weeks. Recent evidence suggests that viral reactivation of human herpesvirus 6 and human herpesvirus 7 may play a role in the development of skin lesions.² Pityriasis rosea also has been reported following the administration of new medications and vaccinations.^1-3 We report a case of a 30-year-old woman who developed pityriasis rosea 3 days after receiving the second dose of the COVID-19 vaccine.

Case Report

A 30-year-old woman presented to the dermatology office for evaluation of a rash on the trunk and upper extremities that had been present for 5 days. She reported an initial solitary lesion on the left upper back, subsequently followed by the appearance of a mildly pruritic rash on the trunk and upper extremities. The rash first appeared 3 days after she received the second dose of the Pfizer-BioNTech COVID-19 vaccine. She was otherwise asymptomatic after vaccination and denied fever, chills, headache, and myalgia. She denied any rash following her first dose of the COVID-19 vaccine, history of known COVID-19 infection or exposures, or new medications. Notably, the patient worked in health care.

Physical examination revealed a 2-cm, erythematous, thin, scaly plaque over the left side of the upper back (Figure, A). Erythematous, scaly, thin papules of varying sizes were distributed along the cleavage lines of the trunk and upper extremities (Figure, B). No biopsy was performed because of the classic clinical presentation of this self-limited condition and the patient’s history of hypertrophic scarring. No additional laboratory workup was performed. She was prescribed triamcinolone cream 0.1% as needed for pruritus and was reassured about the benign nature of this cutaneous eruption.

Comment

A broad spectrum of cutaneous manifestations has been reported in association with acute COVID-19 infection, including a papulovesicular rash, perniolike eruptions, urticaria, livedo reticularis, and petechiae.⁴ Several cases of pityriasis rosea in association with acute COVID-19 infection also have been reported.⁵ COVID-19 infection has been linked to reactivation of the herpesvirus, which may explain the connection between acute COVID-19 infection and the development of pityriasis rosea.⁶ Pityriasis rosea associated with administration of the COVID-19 vaccine is a rare complication with few reports in the literature.⁷ Similar to our patient, there are reports of pityriasis rosea developing after the second dose of the vaccine, with some patients reporting a reactivation of skin lesions.⁸ There is a paucity of reports describing pityriasis rosea associated with the influenza vaccine, hepatitis B vaccine, and human papillomavirus vaccine.³ In such cases, the onset of skin lesions was thought to be related to vaccine-induced stimulation of the immune system or a component of the vaccine.

Conclusion

We presented a unique case of pityriasis rosea following COVID-19 vaccination. Because additional laboratory workup and a skin biopsy were not performed, we are unable to infer causation. However, the classic clinical presentation, rash development within 3 days of vaccination, and prior reports of vaccine-associated pityriasis rosea strengthen the aforementioned association. We hope this case adds to the growing understanding of the novel COVID-19 vaccine. As more individuals become vaccinated, both clinicians and patients should be aware of this benign cutaneous eruption that can develop following COVID-19 vaccination.

The Diagnosis: Multicentric Reticulohistiocytosis

Te patient presented with pink papules coalescing into plaques on the upper chest and lower back (Figure 1) as well as a characteristic finding of periungual papules with a coral bead appearance. Histopathologic examination revealed a dense infiltrate of epithelioid histiocytes with amphophilic ground-glass cytoplasm in a nodular configuration (Figure 2). This pattern in conjunction with the clinical features seen in our patient was consistent with a diagnosis of multicentric reticulohistiocytosis (MRH).^1-3 The cutaneous symptoms were managed with triamcinolone ointment 0.1% twice daily and oral hydroxyzine 10 mg 3 times daily as needed for itching with moderate improvement. She was referred to rheumatology for arthritis management, and the initial cancer screening was negative.

Multicentric reticulohistiocytosis is a rare granulomatous disease characterized by papulonodular cutaneous lesions and severe erosive arthritis. It has an insidious onset and most commonly affects middle-aged women.¹ Multicentric reticulohistiocytosis typically presents as rounded pruritic papules or nodules that may be pink, red, or brown primarily affecting the face and distal upper extremities.^1,3 Mucosal involvement occurs in more than half of patients and is characterized by multiple erythematous papules and nodules on the oral and nasopharyngeal mucosae that rarely can produce leonine facies.² A hallmark feature of MRH is the presence of multiple shiny erythematous papules along the proximal and lateral nail folds that take on a coral bead appearance.^1,3,4 Furthermore, nail changes such as atrophy, longitudinal ridging, brittleness, and hyperpigmentation can occur secondary to a synovial reaction that disturbs the nail matrix.^4,5

Joint involvement precedes cutaneous involvement in most cases of MRH.^1,5 Multicentric reticulohistiocytosis is associated with a symmetric destructive arthritis affecting the hands, knees, shoulders, and hips that often is associated with pain, stiffness, and swelling.^1,3 The arthritis rapidly progresses in the early stages of the disease but then becomes less active over the subsequent 8 to 10 years.¹ It has the potential to develop into arthritis mutilans, an end-stage form of arthritis also seen in psoriatic and rheumatoid arthritis that leads to severe joint deformity and debilitation.^1,2

The etiology of MRH still is unknown, but it has an association with underlying malignancy in up to 25% of patients.⁶ Multicentric reticulohistiocytosis has been reported in the context of a wide variety of malignancies including melanoma; sarcoma; lymphoma; leukemia; and carcinomas of the breast, colon, and lung. In some cases, the diagnosis of MRH may even precede the diagnosis of cancer.³ Multicentric reticulohistiocytosis also may be associated with autoimmune conditions,³ as seen in our patient who had a history of both hypothyroidism and vitiligo.

Histopathologic examination is essential in distinguishing MRH from other autoimmune disorders associated with hand lesions, rash, and arthralgia. Erythema elevatum diutinum is associated with symmetric, violaceous, red or brown papules and plaques located on the extensor surfaces of the extremities and hands; however, histology reveals a leukocytoclastic vasculitis with a mixture of polymorphonuclear leukocytes and lymphocytes.⁷ Dermatomyositis may present with arthralgia, flattopped, erythematous (Gottron) papules localized over the proximal interphalangeal and distal interphalangeal joints, as well as proximal nail findings. The latter generally presents with periungual erythema associated with dilated capillary loops rather than the discrete orderly papules seen in MRH. Histologic examination of dermatomyositis shows mild epidermal atrophy, vacuolar changes in the basal keratinocyte layer, and a dermal perivascular lymphocytic infiltrate.⁸ Because MRH initially can present with joint symptoms and hand nodules, it may be confused with rheumatoid arthritis. However, rheumatoid arthritis typically is associated with severe osteopenia and tends to affect the metacarpophalangeal and proximal interphalangeal joints rather than the distal interphalangeal joints that most often are affected in MRH.¹ Histologic examination of rheumatoid nodules reveals palisading granulomas surrounding a central area of fibrinoid necrosis.⁹ Sarcoidosis is a multisystem disease that can present with cutaneous involvement including erythema nodosum, skin plaques, subcutaneous nodules, and papular eruptions in addition to joint lesions.¹⁰ Sarcoidosis most frequently involves the lungs, manifesting as diffuse interstitial lung disease with bilateral hilar lymphadenopathy. Furthermore, histologic examination of lesions demonstrates classic noncaseating granulomas containing epithelioid cells, multinucleated giant cells with inclusion bodies, and lymphocytes.¹¹

A skin biopsy is required to establish the diagnosis of MRH. In general, patients with MRH and no underlying malignancy have a good prognosis and respond to anti-inflammatory therapies such as nonsteroidal antiinflammatory drugs and corticosteroids. Other agents including methotrexate, cyclophosphamide, and tumor necrosis factor α inhibitors also have been effective in more severe cases.^1,3,12 Finally, in addition to treating the cutaneous manifestations of MRH, it is important to screen patients for underlying malignancies and other autoimmune conditions.

The Diagnosis: Multicentric Reticulohistiocytosis

Te patient presented with pink papules coalescing into plaques on the upper chest and lower back (Figure 1) as well as a characteristic finding of periungual papules with a coral bead appearance. Histopathologic examination revealed a dense infiltrate of epithelioid histiocytes with amphophilic ground-glass cytoplasm in a nodular configuration (Figure 2). This pattern in conjunction with the clinical features seen in our patient was consistent with a diagnosis of multicentric reticulohistiocytosis (MRH).^1-3 The cutaneous symptoms were managed with triamcinolone ointment 0.1% twice daily and oral hydroxyzine 10 mg 3 times daily as needed for itching with moderate improvement. She was referred to rheumatology for arthritis management, and the initial cancer screening was negative.

Multicentric reticulohistiocytosis is a rare granulomatous disease characterized by papulonodular cutaneous lesions and severe erosive arthritis. It has an insidious onset and most commonly affects middle-aged women.¹ Multicentric reticulohistiocytosis typically presents as rounded pruritic papules or nodules that may be pink, red, or brown primarily affecting the face and distal upper extremities.^1,3 Mucosal involvement occurs in more than half of patients and is characterized by multiple erythematous papules and nodules on the oral and nasopharyngeal mucosae that rarely can produce leonine facies.² A hallmark feature of MRH is the presence of multiple shiny erythematous papules along the proximal and lateral nail folds that take on a coral bead appearance.^1,3,4 Furthermore, nail changes such as atrophy, longitudinal ridging, brittleness, and hyperpigmentation can occur secondary to a synovial reaction that disturbs the nail matrix.^4,5

Joint involvement precedes cutaneous involvement in most cases of MRH.^1,5 Multicentric reticulohistiocytosis is associated with a symmetric destructive arthritis affecting the hands, knees, shoulders, and hips that often is associated with pain, stiffness, and swelling.^1,3 The arthritis rapidly progresses in the early stages of the disease but then becomes less active over the subsequent 8 to 10 years.¹ It has the potential to develop into arthritis mutilans, an end-stage form of arthritis also seen in psoriatic and rheumatoid arthritis that leads to severe joint deformity and debilitation.^1,2

The etiology of MRH still is unknown, but it has an association with underlying malignancy in up to 25% of patients.⁶ Multicentric reticulohistiocytosis has been reported in the context of a wide variety of malignancies including melanoma; sarcoma; lymphoma; leukemia; and carcinomas of the breast, colon, and lung. In some cases, the diagnosis of MRH may even precede the diagnosis of cancer.³ Multicentric reticulohistiocytosis also may be associated with autoimmune conditions,³ as seen in our patient who had a history of both hypothyroidism and vitiligo.

Histopathologic examination is essential in distinguishing MRH from other autoimmune disorders associated with hand lesions, rash, and arthralgia. Erythema elevatum diutinum is associated with symmetric, violaceous, red or brown papules and plaques located on the extensor surfaces of the extremities and hands; however, histology reveals a leukocytoclastic vasculitis with a mixture of polymorphonuclear leukocytes and lymphocytes.⁷ Dermatomyositis may present with arthralgia, flattopped, erythematous (Gottron) papules localized over the proximal interphalangeal and distal interphalangeal joints, as well as proximal nail findings. The latter generally presents with periungual erythema associated with dilated capillary loops rather than the discrete orderly papules seen in MRH. Histologic examination of dermatomyositis shows mild epidermal atrophy, vacuolar changes in the basal keratinocyte layer, and a dermal perivascular lymphocytic infiltrate.⁸ Because MRH initially can present with joint symptoms and hand nodules, it may be confused with rheumatoid arthritis. However, rheumatoid arthritis typically is associated with severe osteopenia and tends to affect the metacarpophalangeal and proximal interphalangeal joints rather than the distal interphalangeal joints that most often are affected in MRH.¹ Histologic examination of rheumatoid nodules reveals palisading granulomas surrounding a central area of fibrinoid necrosis.⁹ Sarcoidosis is a multisystem disease that can present with cutaneous involvement including erythema nodosum, skin plaques, subcutaneous nodules, and papular eruptions in addition to joint lesions.¹⁰ Sarcoidosis most frequently involves the lungs, manifesting as diffuse interstitial lung disease with bilateral hilar lymphadenopathy. Furthermore, histologic examination of lesions demonstrates classic noncaseating granulomas containing epithelioid cells, multinucleated giant cells with inclusion bodies, and lymphocytes.¹¹

A skin biopsy is required to establish the diagnosis of MRH. In general, patients with MRH and no underlying malignancy have a good prognosis and respond to anti-inflammatory therapies such as nonsteroidal antiinflammatory drugs and corticosteroids. Other agents including methotrexate, cyclophosphamide, and tumor necrosis factor α inhibitors also have been effective in more severe cases.^1,3,12 Finally, in addition to treating the cutaneous manifestations of MRH, it is important to screen patients for underlying malignancies and other autoimmune conditions.

The Diagnosis: Multicentric Reticulohistiocytosis

Te patient presented with pink papules coalescing into plaques on the upper chest and lower back (Figure 1) as well as a characteristic finding of periungual papules with a coral bead appearance. Histopathologic examination revealed a dense infiltrate of epithelioid histiocytes with amphophilic ground-glass cytoplasm in a nodular configuration (Figure 2). This pattern in conjunction with the clinical features seen in our patient was consistent with a diagnosis of multicentric reticulohistiocytosis (MRH).^1-3 The cutaneous symptoms were managed with triamcinolone ointment 0.1% twice daily and oral hydroxyzine 10 mg 3 times daily as needed for itching with moderate improvement. She was referred to rheumatology for arthritis management, and the initial cancer screening was negative.

Multicentric reticulohistiocytosis is a rare granulomatous disease characterized by papulonodular cutaneous lesions and severe erosive arthritis. It has an insidious onset and most commonly affects middle-aged women.¹ Multicentric reticulohistiocytosis typically presents as rounded pruritic papules or nodules that may be pink, red, or brown primarily affecting the face and distal upper extremities.^1,3 Mucosal involvement occurs in more than half of patients and is characterized by multiple erythematous papules and nodules on the oral and nasopharyngeal mucosae that rarely can produce leonine facies.² A hallmark feature of MRH is the presence of multiple shiny erythematous papules along the proximal and lateral nail folds that take on a coral bead appearance.^1,3,4 Furthermore, nail changes such as atrophy, longitudinal ridging, brittleness, and hyperpigmentation can occur secondary to a synovial reaction that disturbs the nail matrix.^4,5

Joint involvement precedes cutaneous involvement in most cases of MRH.^1,5 Multicentric reticulohistiocytosis is associated with a symmetric destructive arthritis affecting the hands, knees, shoulders, and hips that often is associated with pain, stiffness, and swelling.^1,3 The arthritis rapidly progresses in the early stages of the disease but then becomes less active over the subsequent 8 to 10 years.¹ It has the potential to develop into arthritis mutilans, an end-stage form of arthritis also seen in psoriatic and rheumatoid arthritis that leads to severe joint deformity and debilitation.^1,2

The etiology of MRH still is unknown, but it has an association with underlying malignancy in up to 25% of patients.⁶ Multicentric reticulohistiocytosis has been reported in the context of a wide variety of malignancies including melanoma; sarcoma; lymphoma; leukemia; and carcinomas of the breast, colon, and lung. In some cases, the diagnosis of MRH may even precede the diagnosis of cancer.³ Multicentric reticulohistiocytosis also may be associated with autoimmune conditions,³ as seen in our patient who had a history of both hypothyroidism and vitiligo.

Histopathologic examination is essential in distinguishing MRH from other autoimmune disorders associated with hand lesions, rash, and arthralgia. Erythema elevatum diutinum is associated with symmetric, violaceous, red or brown papules and plaques located on the extensor surfaces of the extremities and hands; however, histology reveals a leukocytoclastic vasculitis with a mixture of polymorphonuclear leukocytes and lymphocytes.⁷ Dermatomyositis may present with arthralgia, flattopped, erythematous (Gottron) papules localized over the proximal interphalangeal and distal interphalangeal joints, as well as proximal nail findings. The latter generally presents with periungual erythema associated with dilated capillary loops rather than the discrete orderly papules seen in MRH. Histologic examination of dermatomyositis shows mild epidermal atrophy, vacuolar changes in the basal keratinocyte layer, and a dermal perivascular lymphocytic infiltrate.⁸ Because MRH initially can present with joint symptoms and hand nodules, it may be confused with rheumatoid arthritis. However, rheumatoid arthritis typically is associated with severe osteopenia and tends to affect the metacarpophalangeal and proximal interphalangeal joints rather than the distal interphalangeal joints that most often are affected in MRH.¹ Histologic examination of rheumatoid nodules reveals palisading granulomas surrounding a central area of fibrinoid necrosis.⁹ Sarcoidosis is a multisystem disease that can present with cutaneous involvement including erythema nodosum, skin plaques, subcutaneous nodules, and papular eruptions in addition to joint lesions.¹⁰ Sarcoidosis most frequently involves the lungs, manifesting as diffuse interstitial lung disease with bilateral hilar lymphadenopathy. Furthermore, histologic examination of lesions demonstrates classic noncaseating granulomas containing epithelioid cells, multinucleated giant cells with inclusion bodies, and lymphocytes.¹¹

A skin biopsy is required to establish the diagnosis of MRH. In general, patients with MRH and no underlying malignancy have a good prognosis and respond to anti-inflammatory therapies such as nonsteroidal antiinflammatory drugs and corticosteroids. Other agents including methotrexate, cyclophosphamide, and tumor necrosis factor α inhibitors also have been effective in more severe cases.^1,3,12 Finally, in addition to treating the cutaneous manifestations of MRH, it is important to screen patients for underlying malignancies and other autoimmune conditions.

ANSWER

The correct answer is bullous impetigo (choice “a”).

Had the source of the problem been MRSA (choice “b”), there would have been marked tenderness and swelling. Psoriasis vulgaris (choice “c”) was a possibility; however, it almost never manifests with blisters, it rarely comes on as quickly as this patient’s problem did, and it produces scale that is far thicker and more tenacious than that seen in bullous impetigo. Nummular eczema (choice “d”) does not manifest with blisters and would likely have caused itching.

DISCUSSION

Impetigo is one of many common skin diseases—other examples include granuloma annulare and lichen planus—that have bullous variants, which can make diagnosis challenging. Impetigo is easy to diagnose in its more common papulosquamous form. But it also can manifest with flaccid blisters that last only a short time, leaving the round, scaly lesions seen in this case.

Staphylococcus aureus, the organism responsible for bullous impetigo, elaborates serine proteases, which bind to and cleave desmoglein-1. This effectively destroys the connections between skin layers, creating a space that is quickly filled with serum. The level of this separation is typically subcorneal, which allows the formation of a very thin, friable roof for the bulla.

This modern version of impetigo is not considered dangerous, despite its association with staph aureus. In pre-antibiotic times, the predominant organism was streptococcal, some types of which could be nephritogenic—that is, capable of causing Bright disease or, as it is now known, acute post-streptococcal glomerulonephritis. Fortunately, this potentially fatal condition is only rarely seen in modern times.

Two items of note about this case: Bullous impetigo, contrary to what was seen in this patient, typically favors intertriginous areas. And a key factor is the history of atopy, which renders the patient more susceptible to skin infections of all kinds.

Treatment

The patient responded well to topical mupirocin ointment, applied three times a day. In rare instances, impetigo can require an oral antibiotic, such as cephalexin.

ANSWER

The correct answer is bullous impetigo (choice “a”).

Had the source of the problem been MRSA (choice “b”), there would have been marked tenderness and swelling. Psoriasis vulgaris (choice “c”) was a possibility; however, it almost never manifests with blisters, it rarely comes on as quickly as this patient’s problem did, and it produces scale that is far thicker and more tenacious than that seen in bullous impetigo. Nummular eczema (choice “d”) does not manifest with blisters and would likely have caused itching.

DISCUSSION

Impetigo is one of many common skin diseases—other examples include granuloma annulare and lichen planus—that have bullous variants, which can make diagnosis challenging. Impetigo is easy to diagnose in its more common papulosquamous form. But it also can manifest with flaccid blisters that last only a short time, leaving the round, scaly lesions seen in this case.

Staphylococcus aureus, the organism responsible for bullous impetigo, elaborates serine proteases, which bind to and cleave desmoglein-1. This effectively destroys the connections between skin layers, creating a space that is quickly filled with serum. The level of this separation is typically subcorneal, which allows the formation of a very thin, friable roof for the bulla.

This modern version of impetigo is not considered dangerous, despite its association with staph aureus. In pre-antibiotic times, the predominant organism was streptococcal, some types of which could be nephritogenic—that is, capable of causing Bright disease or, as it is now known, acute post-streptococcal glomerulonephritis. Fortunately, this potentially fatal condition is only rarely seen in modern times.

Two items of note about this case: Bullous impetigo, contrary to what was seen in this patient, typically favors intertriginous areas. And a key factor is the history of atopy, which renders the patient more susceptible to skin infections of all kinds.

Treatment

The patient responded well to topical mupirocin ointment, applied three times a day. In rare instances, impetigo can require an oral antibiotic, such as cephalexin.

ANSWER

The correct answer is bullous impetigo (choice “a”).

Had the source of the problem been MRSA (choice “b”), there would have been marked tenderness and swelling. Psoriasis vulgaris (choice “c”) was a possibility; however, it almost never manifests with blisters, it rarely comes on as quickly as this patient’s problem did, and it produces scale that is far thicker and more tenacious than that seen in bullous impetigo. Nummular eczema (choice “d”) does not manifest with blisters and would likely have caused itching.

DISCUSSION

Impetigo is one of many common skin diseases—other examples include granuloma annulare and lichen planus—that have bullous variants, which can make diagnosis challenging. Impetigo is easy to diagnose in its more common papulosquamous form. But it also can manifest with flaccid blisters that last only a short time, leaving the round, scaly lesions seen in this case.

Staphylococcus aureus, the organism responsible for bullous impetigo, elaborates serine proteases, which bind to and cleave desmoglein-1. This effectively destroys the connections between skin layers, creating a space that is quickly filled with serum. The level of this separation is typically subcorneal, which allows the formation of a very thin, friable roof for the bulla.

This modern version of impetigo is not considered dangerous, despite its association with staph aureus. In pre-antibiotic times, the predominant organism was streptococcal, some types of which could be nephritogenic—that is, capable of causing Bright disease or, as it is now known, acute post-streptococcal glomerulonephritis. Fortunately, this potentially fatal condition is only rarely seen in modern times.

Two items of note about this case: Bullous impetigo, contrary to what was seen in this patient, typically favors intertriginous areas. And a key factor is the history of atopy, which renders the patient more susceptible to skin infections of all kinds.

Treatment

The patient responded well to topical mupirocin ointment, applied three times a day. In rare instances, impetigo can require an oral antibiotic, such as cephalexin.

As more indoor venues require proof of vaccination for entrance and with winter — as well as omicron, a new COVID variant — looming, scientists and public health officials are debating when it will be time to change the definition of “fully vaccinated” to include a booster shot.

It’s been more than six months since many Americans finished their vaccination course against COVID; statistically, their immunity is waning.

At the same time, cases of infections with the Omicron variant have been reported in at least 17 states, as of Dec. 6. Omicron is distinguished by at least 50 mutations, some of which appear to be associated with increased transmissibility. The World Health Organization dubbed it a variant of concern on Nov. 26.

The Centers for Disease Control and Prevention has recommended that everyone 18 and older get a COVID booster shot, revising its narrower guidance that only people 50 and up “should” get a shot while younger adults could choose whether or not to do so. Scientists assume the additional shots will offer significant protection from the new variant, though they do not know for certain how much.

Anthony Fauci, MD, chief medical adviser to President Joe Biden, during a White House press briefing was unequivocal in advising the public. “Get boosted now,” Dr. Fauci said, adding urgency to the current federal guidance. About a quarter of U.S. adults have received additional vaccine doses.

“The definition of ‘fully vaccinated’ has not changed. That’s, you know, after your second dose of a Pfizer or Moderna vaccine, after your single dose of a Johnson & Johnson vaccine,” said the CDC’s director, Dr. Rochelle Walensky, during a Nov. 30 White House briefing on COVID. “We are absolutely encouraging those who are eligible for a boost six months after those mRNA doses to get your boost. But we are not changing the definition of ‘fully vaccinated’ right now.” A booster is recommended two months after receiving the J&J shot.

But that, she noted, could change: “As that science evolves, we will look at whether we need to update our definition of ‘fully vaccinated.’”

Still, the Democratic governors of Connecticut and New Mexico are sending a different signal in their states, as are some countries — such as Israel, which arguably has been the most aggressive nation in its approach. Some scientists point out that many vaccines involve three doses over six months for robust long-term protection, such as the shot against hepatitis. So “fully vaccinated” may need to include shot No. 3 to be considered a full course.

“In my view, if you were vaccinated more than six months ago, you’re not fully vaccinated,” Connecticut Gov. Ned Lamont said Nov. 18 during a press briefing. He was encouraging everyone to get boosted at that time, even before the federal government authorized extra shots for everyone.

New Mexico Gov. Michelle Lujan Grisham had a similar response in mid-November, saying she defined “fully vaccinated” as receiving three shots of the mRNA type. She also opened up booster eligibility to all of her state residents before the CDC and Food and Drug Administration did.

What do the varying views on the evolving science mean for vaccine requirements imposed on travelers, or by schools or workplaces? And what about businesses that have required patrons to provide proof of vaccination?

Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Pennsylvania, said the CDC’s stronger recommendation for everyone to get boosted signals to him that a booster is now part of the vaccine regimen. Yet Dr. Offit, who is also a member of the FDA’s vaccine advisory committee, wrote a joint op-ed this week in which he and two other scientists argued that boosters were not yet needed for everyone and that healthy young people should wait to see whether an Omicron-specific booster might be needed.

“I think when the CDC said they are recommending a third dose, they just made the statement that this is a three-dose vaccine series,” Dr. Offit told KHN. “And, frankly, I think it’s going to throw a wrench into mandates.”

Yet to be determined is whether restaurants or other places of business will look more closely at vaccine cards for the booster.

Dr. Georges Benjamin, executive director of the American Public Health Association, said it’s too early to say. “For now, businesses should stay focused on current guidelines,” he said.

Dr. Marc Siegel, an associate professor of medicine at the George Washington School of Medicine and Health Sciences, in Washington, said the question of whether you are fully vaccinated with just two doses or need a booster is a question of semantics. COVID immunity level is the more important issue.

Dr. Siegel said he thinks more suitable terminology would be to call someone “appropriately” or “adequately” vaccinated against COVID rather than “fully” vaccinated, since it’s possible that more boosters could be needed in the future — making “full vaccination” a moving target.

But, as with so many aspects of the pandemic, ambiguity prevails — both in federal guidance on the definition of “fully vaccinated” and in entrance policies, which vary by state, school and business.

Right now, businesses don’t appear to be checking for boosters, but that could change. So, it may be wise to first check the requirements — lest patrons present a two-shot vaccine passport, only to be turned away as inadequately protected.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

As more indoor venues require proof of vaccination for entrance and with winter — as well as omicron, a new COVID variant — looming, scientists and public health officials are debating when it will be time to change the definition of “fully vaccinated” to include a booster shot.

It’s been more than six months since many Americans finished their vaccination course against COVID; statistically, their immunity is waning.

At the same time, cases of infections with the Omicron variant have been reported in at least 17 states, as of Dec. 6. Omicron is distinguished by at least 50 mutations, some of which appear to be associated with increased transmissibility. The World Health Organization dubbed it a variant of concern on Nov. 26.

The Centers for Disease Control and Prevention has recommended that everyone 18 and older get a COVID booster shot, revising its narrower guidance that only people 50 and up “should” get a shot while younger adults could choose whether or not to do so. Scientists assume the additional shots will offer significant protection from the new variant, though they do not know for certain how much.

Anthony Fauci, MD, chief medical adviser to President Joe Biden, during a White House press briefing was unequivocal in advising the public. “Get boosted now,” Dr. Fauci said, adding urgency to the current federal guidance. About a quarter of U.S. adults have received additional vaccine doses.

“The definition of ‘fully vaccinated’ has not changed. That’s, you know, after your second dose of a Pfizer or Moderna vaccine, after your single dose of a Johnson & Johnson vaccine,” said the CDC’s director, Dr. Rochelle Walensky, during a Nov. 30 White House briefing on COVID. “We are absolutely encouraging those who are eligible for a boost six months after those mRNA doses to get your boost. But we are not changing the definition of ‘fully vaccinated’ right now.” A booster is recommended two months after receiving the J&J shot.

But that, she noted, could change: “As that science evolves, we will look at whether we need to update our definition of ‘fully vaccinated.’”

Still, the Democratic governors of Connecticut and New Mexico are sending a different signal in their states, as are some countries — such as Israel, which arguably has been the most aggressive nation in its approach. Some scientists point out that many vaccines involve three doses over six months for robust long-term protection, such as the shot against hepatitis. So “fully vaccinated” may need to include shot No. 3 to be considered a full course.

“In my view, if you were vaccinated more than six months ago, you’re not fully vaccinated,” Connecticut Gov. Ned Lamont said Nov. 18 during a press briefing. He was encouraging everyone to get boosted at that time, even before the federal government authorized extra shots for everyone.

New Mexico Gov. Michelle Lujan Grisham had a similar response in mid-November, saying she defined “fully vaccinated” as receiving three shots of the mRNA type. She also opened up booster eligibility to all of her state residents before the CDC and Food and Drug Administration did.

What do the varying views on the evolving science mean for vaccine requirements imposed on travelers, or by schools or workplaces? And what about businesses that have required patrons to provide proof of vaccination?

Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Pennsylvania, said the CDC’s stronger recommendation for everyone to get boosted signals to him that a booster is now part of the vaccine regimen. Yet Dr. Offit, who is also a member of the FDA’s vaccine advisory committee, wrote a joint op-ed this week in which he and two other scientists argued that boosters were not yet needed for everyone and that healthy young people should wait to see whether an Omicron-specific booster might be needed.

“I think when the CDC said they are recommending a third dose, they just made the statement that this is a three-dose vaccine series,” Dr. Offit told KHN. “And, frankly, I think it’s going to throw a wrench into mandates.”

Yet to be determined is whether restaurants or other places of business will look more closely at vaccine cards for the booster.

Dr. Georges Benjamin, executive director of the American Public Health Association, said it’s too early to say. “For now, businesses should stay focused on current guidelines,” he said.

Dr. Marc Siegel, an associate professor of medicine at the George Washington School of Medicine and Health Sciences, in Washington, said the question of whether you are fully vaccinated with just two doses or need a booster is a question of semantics. COVID immunity level is the more important issue.

Dr. Siegel said he thinks more suitable terminology would be to call someone “appropriately” or “adequately” vaccinated against COVID rather than “fully” vaccinated, since it’s possible that more boosters could be needed in the future — making “full vaccination” a moving target.

But, as with so many aspects of the pandemic, ambiguity prevails — both in federal guidance on the definition of “fully vaccinated” and in entrance policies, which vary by state, school and business.

Right now, businesses don’t appear to be checking for boosters, but that could change. So, it may be wise to first check the requirements — lest patrons present a two-shot vaccine passport, only to be turned away as inadequately protected.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

As more indoor venues require proof of vaccination for entrance and with winter — as well as omicron, a new COVID variant — looming, scientists and public health officials are debating when it will be time to change the definition of “fully vaccinated” to include a booster shot.

It’s been more than six months since many Americans finished their vaccination course against COVID; statistically, their immunity is waning.

At the same time, cases of infections with the Omicron variant have been reported in at least 17 states, as of Dec. 6. Omicron is distinguished by at least 50 mutations, some of which appear to be associated with increased transmissibility. The World Health Organization dubbed it a variant of concern on Nov. 26.

The Centers for Disease Control and Prevention has recommended that everyone 18 and older get a COVID booster shot, revising its narrower guidance that only people 50 and up “should” get a shot while younger adults could choose whether or not to do so. Scientists assume the additional shots will offer significant protection from the new variant, though they do not know for certain how much.

Anthony Fauci, MD, chief medical adviser to President Joe Biden, during a White House press briefing was unequivocal in advising the public. “Get boosted now,” Dr. Fauci said, adding urgency to the current federal guidance. About a quarter of U.S. adults have received additional vaccine doses.

“The definition of ‘fully vaccinated’ has not changed. That’s, you know, after your second dose of a Pfizer or Moderna vaccine, after your single dose of a Johnson & Johnson vaccine,” said the CDC’s director, Dr. Rochelle Walensky, during a Nov. 30 White House briefing on COVID. “We are absolutely encouraging those who are eligible for a boost six months after those mRNA doses to get your boost. But we are not changing the definition of ‘fully vaccinated’ right now.” A booster is recommended two months after receiving the J&J shot.

But that, she noted, could change: “As that science evolves, we will look at whether we need to update our definition of ‘fully vaccinated.’”

Still, the Democratic governors of Connecticut and New Mexico are sending a different signal in their states, as are some countries — such as Israel, which arguably has been the most aggressive nation in its approach. Some scientists point out that many vaccines involve three doses over six months for robust long-term protection, such as the shot against hepatitis. So “fully vaccinated” may need to include shot No. 3 to be considered a full course.

“In my view, if you were vaccinated more than six months ago, you’re not fully vaccinated,” Connecticut Gov. Ned Lamont said Nov. 18 during a press briefing. He was encouraging everyone to get boosted at that time, even before the federal government authorized extra shots for everyone.

New Mexico Gov. Michelle Lujan Grisham had a similar response in mid-November, saying she defined “fully vaccinated” as receiving three shots of the mRNA type. She also opened up booster eligibility to all of her state residents before the CDC and Food and Drug Administration did.

What do the varying views on the evolving science mean for vaccine requirements imposed on travelers, or by schools or workplaces? And what about businesses that have required patrons to provide proof of vaccination?

Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Pennsylvania, said the CDC’s stronger recommendation for everyone to get boosted signals to him that a booster is now part of the vaccine regimen. Yet Dr. Offit, who is also a member of the FDA’s vaccine advisory committee, wrote a joint op-ed this week in which he and two other scientists argued that boosters were not yet needed for everyone and that healthy young people should wait to see whether an Omicron-specific booster might be needed.

“I think when the CDC said they are recommending a third dose, they just made the statement that this is a three-dose vaccine series,” Dr. Offit told KHN. “And, frankly, I think it’s going to throw a wrench into mandates.”

Yet to be determined is whether restaurants or other places of business will look more closely at vaccine cards for the booster.

Dr. Georges Benjamin, executive director of the American Public Health Association, said it’s too early to say. “For now, businesses should stay focused on current guidelines,” he said.

Dr. Marc Siegel, an associate professor of medicine at the George Washington School of Medicine and Health Sciences, in Washington, said the question of whether you are fully vaccinated with just two doses or need a booster is a question of semantics. COVID immunity level is the more important issue.

Dr. Siegel said he thinks more suitable terminology would be to call someone “appropriately” or “adequately” vaccinated against COVID rather than “fully” vaccinated, since it’s possible that more boosters could be needed in the future — making “full vaccination” a moving target.

But, as with so many aspects of the pandemic, ambiguity prevails — both in federal guidance on the definition of “fully vaccinated” and in entrance policies, which vary by state, school and business.

Right now, businesses don’t appear to be checking for boosters, but that could change. So, it may be wise to first check the requirements — lest patrons present a two-shot vaccine passport, only to be turned away as inadequately protected.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Background: VTE is common in patients with cancer and can lead to serious complications and death. Relatively recently, the use of edoxaban or rivaroxaban was recommended by major guidelines for the treatment of cancer-associated VTE. Previous studies have demonstrated a higher risk of major bleeding when compared with low-molecular-weight heparin. Whether oral apixaban can be safely used in this setting is unknown.

Dr. Hermansen is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: VTE is common in patients with cancer and can lead to serious complications and death. Relatively recently, the use of edoxaban or rivaroxaban was recommended by major guidelines for the treatment of cancer-associated VTE. Previous studies have demonstrated a higher risk of major bleeding when compared with low-molecular-weight heparin. Whether oral apixaban can be safely used in this setting is unknown.

Dr. Hermansen is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: VTE is common in patients with cancer and can lead to serious complications and death. Relatively recently, the use of edoxaban or rivaroxaban was recommended by major guidelines for the treatment of cancer-associated VTE. Previous studies have demonstrated a higher risk of major bleeding when compared with low-molecular-weight heparin. Whether oral apixaban can be safely used in this setting is unknown.

Dr. Hermansen is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.

Kuzma/istockphoto

Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.

The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.

Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. Well-intentioned medical professionals may be tempted to promote the information and products featured on websites that advocate for unproven products and protocols. This can have serious legal consequences.
 

The crux of the issue

This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.

On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:

“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”

 

What are the legal consequences?

Medical malpractice

The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.

The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.

By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.

In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.

In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
 

Professional licensing action

Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.

This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.

In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.

The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.

The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.

Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.

Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.

In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
 

Peer review and affected privileges

Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.

The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
 

Criminal charges

Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.

Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
 

Breach of contract

Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.

Reputation/credibility damage and the attendant consequences

In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.

Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.

In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
 

Violation of the COVID-19 Consumer Protection Act of 2020

For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.

The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.

Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”

After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.

In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
 

Conclusion

It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.

Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.

The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.

Kuzma/istockphoto

Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.

The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.

Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. Well-intentioned medical professionals may be tempted to promote the information and products featured on websites that advocate for unproven products and protocols. This can have serious legal consequences.
 

The crux of the issue

This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.

On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:

“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”

 

What are the legal consequences?

Medical malpractice

The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.

The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.

By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.

In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.

In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
 

Professional licensing action

Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.

This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.

In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.

The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.

The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.

Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.

Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.

In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
 

Peer review and affected privileges

Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.

The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
 

Criminal charges

Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.

Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
 

Breach of contract

Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.

Reputation/credibility damage and the attendant consequences

In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.

Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.

In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
 

Violation of the COVID-19 Consumer Protection Act of 2020

For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.

The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.

Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”

After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.

In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
 

Conclusion

It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.

Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.

The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.

Kuzma/istockphoto

Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.

The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.

Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. Well-intentioned medical professionals may be tempted to promote the information and products featured on websites that advocate for unproven products and protocols. This can have serious legal consequences.
 

The crux of the issue

This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.

On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:

“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”

 

What are the legal consequences?

Medical malpractice

The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.

The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.

By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.

In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.

In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
 

Professional licensing action

Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.

This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.

In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.

The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.

The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.

Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.

Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.

In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
 

Peer review and affected privileges

Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.

The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
 

Criminal charges

Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.

Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
 

Breach of contract

Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.

Reputation/credibility damage and the attendant consequences

In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.

Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.

In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
 

Violation of the COVID-19 Consumer Protection Act of 2020

For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.

The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.

Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”

After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.

In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
 

Conclusion

It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.

Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.

The American Gastroenterological Association recently published a Clinical Practice Update Commentary outlining surveillance strategies following endoscopic submucosal dissection (ESD) of dysplasia and early gastrointestinal cancer considered pathologically curative.

The suggested practice advice, which was put together by Andrew Y. Wang, MD, of the University of Virginia, Charlottesville, and colleagues, offers timelines and modalities of surveillance based on neoplasia type and location, with accompanying summaries of relevant literature.

“Long-term U.S. data about ESD outcomes for early GI neoplasia are only beginning to emerge,” the authors wrote in Gastroenterology. “As such, the current clinical practice regarding endoscopic surveillance intervals and the need for other testing (such as radiographic imaging) after ESD considered curative by histopathology is extrapolated from data derived from Asia and other countries, from concepts learned from polypectomy and piecemeal endoscopic mucosal resection (EMR), and from guideline recommendations after local surgical resection.”

The authors went on to suggest that current recommendations for post-ESD surveillance, including international guidelines “are based more so on expert opinion than rigorous evidence.”

The present update was written to offer additional clarity in this area by providing “a reasonable framework for clinical care and launch points for future research to refine and standardize optimal post-ESD surveillance strategies.”

Foremost, Dr. Wang and colleagues suggested that post-ESD surveillance is necessary because of a lack of standardization concerning the definition of complete resection, along with variable standards of pathological assessment in Western countries, compared with Japan, where pathologists use 2-3 mm serial sectioning and special stains to detect lymphovascular invasion, “which is essential to accurate histopathologic diagnosis and determination of curative resection.”

According to the authors, surveillance endoscopy should be performed with a high-definition endoscope augmented with dye-based or electronic chromoendoscopy, and ideally with optimal magnification.

“Although no supporting data are available at this time, it is prudent and may be reasonable to obtain central and peripheral biopsies of the post-ESD scar,” the authors wrote, noting that relevant mucosa should be checked for metachronous lesions.
 

Esophageal dysplasia and esophageal squamous cell carcinoma

Following curative resection of low-grade or high-grade esophageal squamous dysplasia, the authors suggested follow-up esophagogastroduodenoscopy (EGD) initially at intervals of 6-12 months, while advising against endoscopic ultrasonography and radiographic surveillance.

In contrast, Dr. Wang and colleagues suggested that superficial esophageal squamous cell carcinoma removed by ESD may benefit from a shorter interval of endoscopic surveillance, with a range of 3-6 months for first and second follow-up EGDs. Clinicians may also consider endoscopic ultrasonography with each EGD, plus an annual CT scan of the abdomen and chest, for 3-5 years.

“A limitation of ESD is that the at-risk esophagus is left in place, and there is a possibility of developing local recurrence or metachronous neoplasia,” the authors wrote. “Although local recurrence after ESD deemed pathologically curative of esophageal squamous cell carcinoma is infrequent, the development of metachronous lesions is not.”
 

Barrett’s dysplasia and esophageal adenocarcinoma

For all patients, curative removal of Barrett’s dysplasia or esophageal adenocarcinoma should be followed by endoscopy with mucosal ablative therapy at 2-3 months, with treatments every 2-3 months until complete eradication of intestinal metaplasia is achieved, according to Dr. Wang and colleagues.

After complete eradication, patients should be endoscopically screened from 3-12 months, depending on the degree of dysplasia or T-stage of adenocarcinoma, followed by screening procedures ranging from 6 months to 3 years, again depending on disease type.

“Endoscopic resection of visible Barrett’s neoplasia without treatment of Barrett’s esophagus has been associated with significant recurrence rates, so the objective of treatment should be endoscopic resection of visible or nodular dysplasia, followed by complete ablation of any remaining Barrett’s esophagus and associated (flat and/or invisible) dysplasia,” the authors wrote.
 

Gastric dysplasia and gastric adenocarcinoma

According to the update, after curative resection of gastric dysplasia, first follow-up endoscopy should be conducted at 6-12 months. Second follow-up should be conducted at 12 months for low-grade dysplasia versus 6-12 months for high-grade dysplasia, with annual exams thereafter.

For T1a early gastric cancer, the first two follow-up endoscopies should be performed at 6-month intervals, followed by annual exams. T1b Sm1 disease should be screened more aggressively, with 3-6 months intervals for first and second follow-up EGDs, plus CT scans of the abdomen and chest and/or endoscopic ultrasound every 6-12 months for 3-5 years.

“For lesions where a curative resection was achieved based on clinical criteria and histopathologic examination, surveillance is performed primarily to detect metachronous gastric cancers,” the authors wrote.
 

Colonic dysplasia and adenocarcinoma

According to the authors, adenomas with low-grade dysplasia or serrated sessile lesions without dysplasia removed by ESD should be rechecked by colonoscopy at 1 year and then 3 years, followed by adherence to U.S. Multi-Society Task Force recommendations.

For traditional serrated adenomas, serrated sessile lesions with dysplasia, adenomas with high-grade dysplasia, carcinoma in situ, intramucosal carcinoma, or dysplasia in the setting of inflammatory bowel disease, first follow-up colonoscopy should be conducted at 6-12 months, 1 year later, then 3 years after that, followed by reversion to USMSTF recommendations, although patients with IBD may benefit from annual colonoscopy.

Finally, patients with superficial T1 colonic adenocarcinoma should be screened more frequently, with colonoscopies at 3-6 months, 6 months, and 1 year, followed by adherence to USMSTF recommendations.

“The current Japanese guideline suggests that recurrence or metastasis after endoscopic resection of T1 (Sm) colonic carcinomas occurs mainly within 3-5 years,” the authors noted.
 

Rectal dysplasia and adenocarcinoma

Best practice advice suggestions for rectal dysplasia and adenocarcinoma are grouped similarly to the above advice for colonic lesions.

For lower-grade lesions, first follow-up with flexible sigmoidoscopy is suggested after 1 year, then 3 years, followed by reversion to USMSTF recommendations. Higher-grade dysplastic lesions should be checked after 6-12 months, 1 year, then 3 years, followed by adherence to USMSTF guidance, again excluding patients with IBD, who may benefit from annual exams.

Patients with superficial T1 rectal adenocarcinoma removed by ESD deemed pathologically curative should be checked with flexible sigmoidoscopy at 3-6 months, again at 3-6 months after first sigmoidoscopy, then every 6 months for a total of 5 years from the time of ESD, followed by adherence to USMSTF recommendations. At 1 year following ESD, patients should undergo colonoscopy, which can take the place of one of the follow-up flexible sigmoidoscopy exams; if an advanced adenoma is found, colonoscopy should be repeated after 1 year, versus 3 years if no advanced adenomas are found, followed by adherence to USMSTF recommendations. Patients with superficial T1 rectal adenocarcinoma should also undergo endoscopic ultrasound or pelvic MRI with contrast every 3-6 months for 2 years, followed by intervals of 6 months for a total of 5 years. Annual CT of the chest and abdomen may also be considered for a duration of 3-5 years.

Call for research

Dr. Wang and colleagues concluded their update with a call for research.

“We acknowledge that the level of evidence currently available to support much of our surveillance advice is generally low,” they wrote. “The intent of this clinical practice update was to propose surveillance strategies after potentially curative ESD for various GI neoplasms, which might also serve as reference points to stimulate research that will refine future clinical best practice advice.”

The article was supported by the AGA. The authors disclosed relationships with MicroTech, Olympus, Lumendi, U.S. Endoscopy, Boston Scientific, Steris and others.

This article was updated Dec. 15, 2021.

The American Gastroenterological Association recently published a Clinical Practice Update Commentary outlining surveillance strategies following endoscopic submucosal dissection (ESD) of dysplasia and early gastrointestinal cancer considered pathologically curative.

The suggested practice advice, which was put together by Andrew Y. Wang, MD, of the University of Virginia, Charlottesville, and colleagues, offers timelines and modalities of surveillance based on neoplasia type and location, with accompanying summaries of relevant literature.

“Long-term U.S. data about ESD outcomes for early GI neoplasia are only beginning to emerge,” the authors wrote in Gastroenterology. “As such, the current clinical practice regarding endoscopic surveillance intervals and the need for other testing (such as radiographic imaging) after ESD considered curative by histopathology is extrapolated from data derived from Asia and other countries, from concepts learned from polypectomy and piecemeal endoscopic mucosal resection (EMR), and from guideline recommendations after local surgical resection.”

The authors went on to suggest that current recommendations for post-ESD surveillance, including international guidelines “are based more so on expert opinion than rigorous evidence.”

The present update was written to offer additional clarity in this area by providing “a reasonable framework for clinical care and launch points for future research to refine and standardize optimal post-ESD surveillance strategies.”

Foremost, Dr. Wang and colleagues suggested that post-ESD surveillance is necessary because of a lack of standardization concerning the definition of complete resection, along with variable standards of pathological assessment in Western countries, compared with Japan, where pathologists use 2-3 mm serial sectioning and special stains to detect lymphovascular invasion, “which is essential to accurate histopathologic diagnosis and determination of curative resection.”

According to the authors, surveillance endoscopy should be performed with a high-definition endoscope augmented with dye-based or electronic chromoendoscopy, and ideally with optimal magnification.

“Although no supporting data are available at this time, it is prudent and may be reasonable to obtain central and peripheral biopsies of the post-ESD scar,” the authors wrote, noting that relevant mucosa should be checked for metachronous lesions.
 

Esophageal dysplasia and esophageal squamous cell carcinoma

Following curative resection of low-grade or high-grade esophageal squamous dysplasia, the authors suggested follow-up esophagogastroduodenoscopy (EGD) initially at intervals of 6-12 months, while advising against endoscopic ultrasonography and radiographic surveillance.

In contrast, Dr. Wang and colleagues suggested that superficial esophageal squamous cell carcinoma removed by ESD may benefit from a shorter interval of endoscopic surveillance, with a range of 3-6 months for first and second follow-up EGDs. Clinicians may also consider endoscopic ultrasonography with each EGD, plus an annual CT scan of the abdomen and chest, for 3-5 years.

“A limitation of ESD is that the at-risk esophagus is left in place, and there is a possibility of developing local recurrence or metachronous neoplasia,” the authors wrote. “Although local recurrence after ESD deemed pathologically curative of esophageal squamous cell carcinoma is infrequent, the development of metachronous lesions is not.”
 

Barrett’s dysplasia and esophageal adenocarcinoma

For all patients, curative removal of Barrett’s dysplasia or esophageal adenocarcinoma should be followed by endoscopy with mucosal ablative therapy at 2-3 months, with treatments every 2-3 months until complete eradication of intestinal metaplasia is achieved, according to Dr. Wang and colleagues.

After complete eradication, patients should be endoscopically screened from 3-12 months, depending on the degree of dysplasia or T-stage of adenocarcinoma, followed by screening procedures ranging from 6 months to 3 years, again depending on disease type.

“Endoscopic resection of visible Barrett’s neoplasia without treatment of Barrett’s esophagus has been associated with significant recurrence rates, so the objective of treatment should be endoscopic resection of visible or nodular dysplasia, followed by complete ablation of any remaining Barrett’s esophagus and associated (flat and/or invisible) dysplasia,” the authors wrote.
 

Gastric dysplasia and gastric adenocarcinoma

According to the update, after curative resection of gastric dysplasia, first follow-up endoscopy should be conducted at 6-12 months. Second follow-up should be conducted at 12 months for low-grade dysplasia versus 6-12 months for high-grade dysplasia, with annual exams thereafter.

For T1a early gastric cancer, the first two follow-up endoscopies should be performed at 6-month intervals, followed by annual exams. T1b Sm1 disease should be screened more aggressively, with 3-6 months intervals for first and second follow-up EGDs, plus CT scans of the abdomen and chest and/or endoscopic ultrasound every 6-12 months for 3-5 years.

“For lesions where a curative resection was achieved based on clinical criteria and histopathologic examination, surveillance is performed primarily to detect metachronous gastric cancers,” the authors wrote.
 

Colonic dysplasia and adenocarcinoma

According to the authors, adenomas with low-grade dysplasia or serrated sessile lesions without dysplasia removed by ESD should be rechecked by colonoscopy at 1 year and then 3 years, followed by adherence to U.S. Multi-Society Task Force recommendations.

For traditional serrated adenomas, serrated sessile lesions with dysplasia, adenomas with high-grade dysplasia, carcinoma in situ, intramucosal carcinoma, or dysplasia in the setting of inflammatory bowel disease, first follow-up colonoscopy should be conducted at 6-12 months, 1 year later, then 3 years after that, followed by reversion to USMSTF recommendations, although patients with IBD may benefit from annual colonoscopy.

Finally, patients with superficial T1 colonic adenocarcinoma should be screened more frequently, with colonoscopies at 3-6 months, 6 months, and 1 year, followed by adherence to USMSTF recommendations.

“The current Japanese guideline suggests that recurrence or metastasis after endoscopic resection of T1 (Sm) colonic carcinomas occurs mainly within 3-5 years,” the authors noted.
 

Rectal dysplasia and adenocarcinoma

Best practice advice suggestions for rectal dysplasia and adenocarcinoma are grouped similarly to the above advice for colonic lesions.

For lower-grade lesions, first follow-up with flexible sigmoidoscopy is suggested after 1 year, then 3 years, followed by reversion to USMSTF recommendations. Higher-grade dysplastic lesions should be checked after 6-12 months, 1 year, then 3 years, followed by adherence to USMSTF guidance, again excluding patients with IBD, who may benefit from annual exams.

Patients with superficial T1 rectal adenocarcinoma removed by ESD deemed pathologically curative should be checked with flexible sigmoidoscopy at 3-6 months, again at 3-6 months after first sigmoidoscopy, then every 6 months for a total of 5 years from the time of ESD, followed by adherence to USMSTF recommendations. At 1 year following ESD, patients should undergo colonoscopy, which can take the place of one of the follow-up flexible sigmoidoscopy exams; if an advanced adenoma is found, colonoscopy should be repeated after 1 year, versus 3 years if no advanced adenomas are found, followed by adherence to USMSTF recommendations. Patients with superficial T1 rectal adenocarcinoma should also undergo endoscopic ultrasound or pelvic MRI with contrast every 3-6 months for 2 years, followed by intervals of 6 months for a total of 5 years. Annual CT of the chest and abdomen may also be considered for a duration of 3-5 years.

Call for research

Dr. Wang and colleagues concluded their update with a call for research.

“We acknowledge that the level of evidence currently available to support much of our surveillance advice is generally low,” they wrote. “The intent of this clinical practice update was to propose surveillance strategies after potentially curative ESD for various GI neoplasms, which might also serve as reference points to stimulate research that will refine future clinical best practice advice.”

The article was supported by the AGA. The authors disclosed relationships with MicroTech, Olympus, Lumendi, U.S. Endoscopy, Boston Scientific, Steris and others.

This article was updated Dec. 15, 2021.

The American Gastroenterological Association recently published a Clinical Practice Update Commentary outlining surveillance strategies following endoscopic submucosal dissection (ESD) of dysplasia and early gastrointestinal cancer considered pathologically curative.

The suggested practice advice, which was put together by Andrew Y. Wang, MD, of the University of Virginia, Charlottesville, and colleagues, offers timelines and modalities of surveillance based on neoplasia type and location, with accompanying summaries of relevant literature.

“Long-term U.S. data about ESD outcomes for early GI neoplasia are only beginning to emerge,” the authors wrote in Gastroenterology. “As such, the current clinical practice regarding endoscopic surveillance intervals and the need for other testing (such as radiographic imaging) after ESD considered curative by histopathology is extrapolated from data derived from Asia and other countries, from concepts learned from polypectomy and piecemeal endoscopic mucosal resection (EMR), and from guideline recommendations after local surgical resection.”

The authors went on to suggest that current recommendations for post-ESD surveillance, including international guidelines “are based more so on expert opinion than rigorous evidence.”

The present update was written to offer additional clarity in this area by providing “a reasonable framework for clinical care and launch points for future research to refine and standardize optimal post-ESD surveillance strategies.”

Foremost, Dr. Wang and colleagues suggested that post-ESD surveillance is necessary because of a lack of standardization concerning the definition of complete resection, along with variable standards of pathological assessment in Western countries, compared with Japan, where pathologists use 2-3 mm serial sectioning and special stains to detect lymphovascular invasion, “which is essential to accurate histopathologic diagnosis and determination of curative resection.”

According to the authors, surveillance endoscopy should be performed with a high-definition endoscope augmented with dye-based or electronic chromoendoscopy, and ideally with optimal magnification.

“Although no supporting data are available at this time, it is prudent and may be reasonable to obtain central and peripheral biopsies of the post-ESD scar,” the authors wrote, noting that relevant mucosa should be checked for metachronous lesions.
 

Esophageal dysplasia and esophageal squamous cell carcinoma

Following curative resection of low-grade or high-grade esophageal squamous dysplasia, the authors suggested follow-up esophagogastroduodenoscopy (EGD) initially at intervals of 6-12 months, while advising against endoscopic ultrasonography and radiographic surveillance.

In contrast, Dr. Wang and colleagues suggested that superficial esophageal squamous cell carcinoma removed by ESD may benefit from a shorter interval of endoscopic surveillance, with a range of 3-6 months for first and second follow-up EGDs. Clinicians may also consider endoscopic ultrasonography with each EGD, plus an annual CT scan of the abdomen and chest, for 3-5 years.

“A limitation of ESD is that the at-risk esophagus is left in place, and there is a possibility of developing local recurrence or metachronous neoplasia,” the authors wrote. “Although local recurrence after ESD deemed pathologically curative of esophageal squamous cell carcinoma is infrequent, the development of metachronous lesions is not.”
 

Barrett’s dysplasia and esophageal adenocarcinoma

For all patients, curative removal of Barrett’s dysplasia or esophageal adenocarcinoma should be followed by endoscopy with mucosal ablative therapy at 2-3 months, with treatments every 2-3 months until complete eradication of intestinal metaplasia is achieved, according to Dr. Wang and colleagues.

After complete eradication, patients should be endoscopically screened from 3-12 months, depending on the degree of dysplasia or T-stage of adenocarcinoma, followed by screening procedures ranging from 6 months to 3 years, again depending on disease type.

“Endoscopic resection of visible Barrett’s neoplasia without treatment of Barrett’s esophagus has been associated with significant recurrence rates, so the objective of treatment should be endoscopic resection of visible or nodular dysplasia, followed by complete ablation of any remaining Barrett’s esophagus and associated (flat and/or invisible) dysplasia,” the authors wrote.
 

Gastric dysplasia and gastric adenocarcinoma

According to the update, after curative resection of gastric dysplasia, first follow-up endoscopy should be conducted at 6-12 months. Second follow-up should be conducted at 12 months for low-grade dysplasia versus 6-12 months for high-grade dysplasia, with annual exams thereafter.

For T1a early gastric cancer, the first two follow-up endoscopies should be performed at 6-month intervals, followed by annual exams. T1b Sm1 disease should be screened more aggressively, with 3-6 months intervals for first and second follow-up EGDs, plus CT scans of the abdomen and chest and/or endoscopic ultrasound every 6-12 months for 3-5 years.

“For lesions where a curative resection was achieved based on clinical criteria and histopathologic examination, surveillance is performed primarily to detect metachronous gastric cancers,” the authors wrote.
 

Colonic dysplasia and adenocarcinoma

According to the authors, adenomas with low-grade dysplasia or serrated sessile lesions without dysplasia removed by ESD should be rechecked by colonoscopy at 1 year and then 3 years, followed by adherence to U.S. Multi-Society Task Force recommendations.

For traditional serrated adenomas, serrated sessile lesions with dysplasia, adenomas with high-grade dysplasia, carcinoma in situ, intramucosal carcinoma, or dysplasia in the setting of inflammatory bowel disease, first follow-up colonoscopy should be conducted at 6-12 months, 1 year later, then 3 years after that, followed by reversion to USMSTF recommendations, although patients with IBD may benefit from annual colonoscopy.

Finally, patients with superficial T1 colonic adenocarcinoma should be screened more frequently, with colonoscopies at 3-6 months, 6 months, and 1 year, followed by adherence to USMSTF recommendations.

“The current Japanese guideline suggests that recurrence or metastasis after endoscopic resection of T1 (Sm) colonic carcinomas occurs mainly within 3-5 years,” the authors noted.
 

Rectal dysplasia and adenocarcinoma

Best practice advice suggestions for rectal dysplasia and adenocarcinoma are grouped similarly to the above advice for colonic lesions.

For lower-grade lesions, first follow-up with flexible sigmoidoscopy is suggested after 1 year, then 3 years, followed by reversion to USMSTF recommendations. Higher-grade dysplastic lesions should be checked after 6-12 months, 1 year, then 3 years, followed by adherence to USMSTF guidance, again excluding patients with IBD, who may benefit from annual exams.

Patients with superficial T1 rectal adenocarcinoma removed by ESD deemed pathologically curative should be checked with flexible sigmoidoscopy at 3-6 months, again at 3-6 months after first sigmoidoscopy, then every 6 months for a total of 5 years from the time of ESD, followed by adherence to USMSTF recommendations. At 1 year following ESD, patients should undergo colonoscopy, which can take the place of one of the follow-up flexible sigmoidoscopy exams; if an advanced adenoma is found, colonoscopy should be repeated after 1 year, versus 3 years if no advanced adenomas are found, followed by adherence to USMSTF recommendations. Patients with superficial T1 rectal adenocarcinoma should also undergo endoscopic ultrasound or pelvic MRI with contrast every 3-6 months for 2 years, followed by intervals of 6 months for a total of 5 years. Annual CT of the chest and abdomen may also be considered for a duration of 3-5 years.

Call for research

Dr. Wang and colleagues concluded their update with a call for research.

“We acknowledge that the level of evidence currently available to support much of our surveillance advice is generally low,” they wrote. “The intent of this clinical practice update was to propose surveillance strategies after potentially curative ESD for various GI neoplasms, which might also serve as reference points to stimulate research that will refine future clinical best practice advice.”

The article was supported by the AGA. The authors disclosed relationships with MicroTech, Olympus, Lumendi, U.S. Endoscopy, Boston Scientific, Steris and others.

This article was updated Dec. 15, 2021.

A former nurse was sentenced to 10 years in prison for the sexual assault of an incapacitated woman in the long-term care facility where he worked as a licensed practical nurse.

The sentence, which took into account the vulnerability of the victim, was the maximum allowed according to a deal in which the former nurse pleaded guilty in September to sexual assault and vulnerable adult abuse. He will also be placed on probation for the rest of his life and will have to register as a sex offender.

The crime came to light in December 2018, when the patient, a 29-year-old woman who lived at Hacienda HealthCare, a private, nonprofit, long-term health care facility, was found giving birth when staff changed her clothes and bedding. The woman, who had lived at the Phoenix facility since she was 3 years old, is not in a coma but has severe cognitive disabilities resulting from seizures. She does not speak but has some ability to move and can respond to sounds and make facial gestures.

According to a 911 call made by staff members, no one knew she was pregnant until she went into labor. “One of the patients just had a baby, and we had no idea she was pregnant,” a nurse told responders on the frantic 911 call.

Police tested the DNA of all male employees at the facility and found the baby’s DNA matched that of Nathan Sutherland, who was the woman’s primary caregiver at the time of the assault. The child, a boy, is being cared for by the woman’s mother.

“It’s hard to imagine a more vulnerable adult than the victim in this case,” said Superior Court Judge Margaret LaBianca when she handed down the sentence, according to the Associated Press

Mr. Sutherland, 39, who surrendered his nursing license after his arrest, apologized to his victim at the sentencing, saying: “You didn’t deserve to be hurt no matter what was going on in my personal life and the demons I was fighting. I had no right to put you through that.”

In a statement to this news organization, Perry Petrilli, CEO of Hacienda HealthCare, said, “For nearly 3 years, our team has cooperated in every way possible with law enforcement and prosecutors in the Sutherland case. We are relieved that [Mr. Sutherland] will never again torment another innocent human being.” He added: “Our thoughts and hearts are with the victim, the victim’s family and loved ones. We hope this last chapter of the Sutherland case brings them all greater peace.”

In June, the court approved a $15 million settlement between the woman’s parents and Phillip Gear Jr., MD, the doctor who cared for the woman during the 26 years she was a patient at Hacienda Healthcare. Dr. Gear died in 2020, prior to the settlement agreement.

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

A former nurse was sentenced to 10 years in prison for the sexual assault of an incapacitated woman in the long-term care facility where he worked as a licensed practical nurse.

The sentence, which took into account the vulnerability of the victim, was the maximum allowed according to a deal in which the former nurse pleaded guilty in September to sexual assault and vulnerable adult abuse. He will also be placed on probation for the rest of his life and will have to register as a sex offender.

The crime came to light in December 2018, when the patient, a 29-year-old woman who lived at Hacienda HealthCare, a private, nonprofit, long-term health care facility, was found giving birth when staff changed her clothes and bedding. The woman, who had lived at the Phoenix facility since she was 3 years old, is not in a coma but has severe cognitive disabilities resulting from seizures. She does not speak but has some ability to move and can respond to sounds and make facial gestures.

According to a 911 call made by staff members, no one knew she was pregnant until she went into labor. “One of the patients just had a baby, and we had no idea she was pregnant,” a nurse told responders on the frantic 911 call.

Police tested the DNA of all male employees at the facility and found the baby’s DNA matched that of Nathan Sutherland, who was the woman’s primary caregiver at the time of the assault. The child, a boy, is being cared for by the woman’s mother.

“It’s hard to imagine a more vulnerable adult than the victim in this case,” said Superior Court Judge Margaret LaBianca when she handed down the sentence, according to the Associated Press

Mr. Sutherland, 39, who surrendered his nursing license after his arrest, apologized to his victim at the sentencing, saying: “You didn’t deserve to be hurt no matter what was going on in my personal life and the demons I was fighting. I had no right to put you through that.”

In a statement to this news organization, Perry Petrilli, CEO of Hacienda HealthCare, said, “For nearly 3 years, our team has cooperated in every way possible with law enforcement and prosecutors in the Sutherland case. We are relieved that [Mr. Sutherland] will never again torment another innocent human being.” He added: “Our thoughts and hearts are with the victim, the victim’s family and loved ones. We hope this last chapter of the Sutherland case brings them all greater peace.”

In June, the court approved a $15 million settlement between the woman’s parents and Phillip Gear Jr., MD, the doctor who cared for the woman during the 26 years she was a patient at Hacienda Healthcare. Dr. Gear died in 2020, prior to the settlement agreement.

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

A former nurse was sentenced to 10 years in prison for the sexual assault of an incapacitated woman in the long-term care facility where he worked as a licensed practical nurse.

The sentence, which took into account the vulnerability of the victim, was the maximum allowed according to a deal in which the former nurse pleaded guilty in September to sexual assault and vulnerable adult abuse. He will also be placed on probation for the rest of his life and will have to register as a sex offender.

The crime came to light in December 2018, when the patient, a 29-year-old woman who lived at Hacienda HealthCare, a private, nonprofit, long-term health care facility, was found giving birth when staff changed her clothes and bedding. The woman, who had lived at the Phoenix facility since she was 3 years old, is not in a coma but has severe cognitive disabilities resulting from seizures. She does not speak but has some ability to move and can respond to sounds and make facial gestures.

According to a 911 call made by staff members, no one knew she was pregnant until she went into labor. “One of the patients just had a baby, and we had no idea she was pregnant,” a nurse told responders on the frantic 911 call.

Police tested the DNA of all male employees at the facility and found the baby’s DNA matched that of Nathan Sutherland, who was the woman’s primary caregiver at the time of the assault. The child, a boy, is being cared for by the woman’s mother.

“It’s hard to imagine a more vulnerable adult than the victim in this case,” said Superior Court Judge Margaret LaBianca when she handed down the sentence, according to the Associated Press

Mr. Sutherland, 39, who surrendered his nursing license after his arrest, apologized to his victim at the sentencing, saying: “You didn’t deserve to be hurt no matter what was going on in my personal life and the demons I was fighting. I had no right to put you through that.”

In a statement to this news organization, Perry Petrilli, CEO of Hacienda HealthCare, said, “For nearly 3 years, our team has cooperated in every way possible with law enforcement and prosecutors in the Sutherland case. We are relieved that [Mr. Sutherland] will never again torment another innocent human being.” He added: “Our thoughts and hearts are with the victim, the victim’s family and loved ones. We hope this last chapter of the Sutherland case brings them all greater peace.”

In June, the court approved a $15 million settlement between the woman’s parents and Phillip Gear Jr., MD, the doctor who cared for the woman during the 26 years she was a patient at Hacienda Healthcare. Dr. Gear died in 2020, prior to the settlement agreement.

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

When the Winship Cancer Institute at Emory University, Atlanta, faced off against the pandemic in the spring of 2020, it opened a COVID urgent care clinic for Winship oncology patients who had a confirmed or suspected case of COVID, symptoms or a higher risk for the virus. The urgent care clinic, located in a relatively isolated bay of an infusion center, facilitated segregating COVID-suspected patients from other cancer patients while waiting for their polymerase chain reaction test results to show if they were COVID positive.

A strict triage system was also employed to make sure that the right patients were coming in to the new clinic and not those who either could be managed safely at home or were clinically unstable and belonged in the hospital, said Caleb Raine, PA-C, an oncology physician assistant and bone marrow transplant specialist at Winship. Mr. Raine, who manages the COVID urgent care clinic, shared his experience of “innovations worth keeping” from the pandemic for oncology practices during a panel discussion at the Journal of the Advanced Practitioner in Oncology annual conference, held online Oct. 7.

Telephonic triage was conducted by advanced practice providers (APPs) or nurses using an algorithm Mr. Raine developed incorporating COVID exposure with symptoms such as fever or loss of taste or smell. In order to promote consistency in admissions, he made the final decisions about which patients were brought into the clinic for evaluations, services such as supportive care or infusions, or to address cancer symptoms.

Mr. Raine said the triage process helped to enhance communication with other clinical teams at Winship. He hopes to preserve a strict approach to triaging in future program development, including a 14-bed immediate care center, projected to open next spring, building on experience with the COVID urgent care center. It will offer services similar to a day hospital for cancer patients but be open 24 hours with more capabilities than urgent care. It will target those with emergent needs or who otherwise might require a trip to the ED and provide care for those recently discharged from the hospital in need of follow-up.
 

Remote monitoring

Another conference speaker, Aaron Begue, MS, RN, CNP, vice president for advanced practice providers at Memorial Sloan Kettering Cancer Center in New York, described a pandemic telemedicine intervention for cancer patients implemented by MSKCC during the pandemic. Prior to in-person contact with the care team, patients were asked to complete a questionnaire on their symptoms using MSKCC’s secure online patient portal, MyMSK.

If symptom alerts reached a critical, color-coded threshold, it triggered a nurse or APP from MSKCC to contact the patient at home, typically by phone. APPs also did remote monitoring, including uploaded data from portable home pulse oximeters. A similar symptom tracker was later adapted for monitoring cancer symptoms.

Some APPs took turns working from their own home collecting data needed for inpatient visits and uploading it into the medical record. This helped to deploy clinical teams more efficiently and accommodate some staff who were at high risk of infection because of existing health conditions or quarantined for positive test results.

“We were able to flex our staffing,” Mr. Begue said. Even spending a day staffing a vaccination clinic could provide a break from the intensity of COVID care on the front lines. “All of us are still trying to figure out how to manage staff stress and burnout,” he added, but flexible scheduling seems to be an important strategy.

Early on, things like the crowds coming out in the evening to cheer for New York’s health care workers had a big impact for staff, showing the community’s support. “Later, when public schools were shut down, we worked with two of them to use their outdoor play areas for staff respite – places to sit down outside undisturbed and relax,” he said.

At the height of the COVID surge in New York, telemedicine was an essential component of care, but when it started to recede, Mr. Begue found that a lot of patients wanted in-person visits again. “We had assumed that telemedicine would be the wave of the future and cancer patients would love it,” he said. “We still do thousands of telemedicine visits, but they are no longer the majority.”

MSKCC also does remote telemonitoring visits with patients who live in other states but want to come to New York for surgeries or other procedures or yearly checkups at the hospital. But the logistical headaches of practicing telemedicine across state lines include trying to reconcile varying requirements for medical licensing.

Mr. Begue hopes in the future that some of these state requirements could be relaxed, which might also make it easier to enroll more people from across the country in clinical trials and encourage more collaboration between cancer centers.

“COVID taught us we have to be more forward thinking and prepared for crises,” Mr. Raine said. “In the future we need to be ready for when – not if – the next crisis comes along – although we’re not out of this one yet.”

Mr. Raine and Mr. Begue did not report any disclosures.

When the Winship Cancer Institute at Emory University, Atlanta, faced off against the pandemic in the spring of 2020, it opened a COVID urgent care clinic for Winship oncology patients who had a confirmed or suspected case of COVID, symptoms or a higher risk for the virus. The urgent care clinic, located in a relatively isolated bay of an infusion center, facilitated segregating COVID-suspected patients from other cancer patients while waiting for their polymerase chain reaction test results to show if they were COVID positive.

A strict triage system was also employed to make sure that the right patients were coming in to the new clinic and not those who either could be managed safely at home or were clinically unstable and belonged in the hospital, said Caleb Raine, PA-C, an oncology physician assistant and bone marrow transplant specialist at Winship. Mr. Raine, who manages the COVID urgent care clinic, shared his experience of “innovations worth keeping” from the pandemic for oncology practices during a panel discussion at the Journal of the Advanced Practitioner in Oncology annual conference, held online Oct. 7.

Telephonic triage was conducted by advanced practice providers (APPs) or nurses using an algorithm Mr. Raine developed incorporating COVID exposure with symptoms such as fever or loss of taste or smell. In order to promote consistency in admissions, he made the final decisions about which patients were brought into the clinic for evaluations, services such as supportive care or infusions, or to address cancer symptoms.

Mr. Raine said the triage process helped to enhance communication with other clinical teams at Winship. He hopes to preserve a strict approach to triaging in future program development, including a 14-bed immediate care center, projected to open next spring, building on experience with the COVID urgent care center. It will offer services similar to a day hospital for cancer patients but be open 24 hours with more capabilities than urgent care. It will target those with emergent needs or who otherwise might require a trip to the ED and provide care for those recently discharged from the hospital in need of follow-up.
 

Remote monitoring

Another conference speaker, Aaron Begue, MS, RN, CNP, vice president for advanced practice providers at Memorial Sloan Kettering Cancer Center in New York, described a pandemic telemedicine intervention for cancer patients implemented by MSKCC during the pandemic. Prior to in-person contact with the care team, patients were asked to complete a questionnaire on their symptoms using MSKCC’s secure online patient portal, MyMSK.

If symptom alerts reached a critical, color-coded threshold, it triggered a nurse or APP from MSKCC to contact the patient at home, typically by phone. APPs also did remote monitoring, including uploaded data from portable home pulse oximeters. A similar symptom tracker was later adapted for monitoring cancer symptoms.

Some APPs took turns working from their own home collecting data needed for inpatient visits and uploading it into the medical record. This helped to deploy clinical teams more efficiently and accommodate some staff who were at high risk of infection because of existing health conditions or quarantined for positive test results.

“We were able to flex our staffing,” Mr. Begue said. Even spending a day staffing a vaccination clinic could provide a break from the intensity of COVID care on the front lines. “All of us are still trying to figure out how to manage staff stress and burnout,” he added, but flexible scheduling seems to be an important strategy.

Early on, things like the crowds coming out in the evening to cheer for New York’s health care workers had a big impact for staff, showing the community’s support. “Later, when public schools were shut down, we worked with two of them to use their outdoor play areas for staff respite – places to sit down outside undisturbed and relax,” he said.

At the height of the COVID surge in New York, telemedicine was an essential component of care, but when it started to recede, Mr. Begue found that a lot of patients wanted in-person visits again. “We had assumed that telemedicine would be the wave of the future and cancer patients would love it,” he said. “We still do thousands of telemedicine visits, but they are no longer the majority.”

MSKCC also does remote telemonitoring visits with patients who live in other states but want to come to New York for surgeries or other procedures or yearly checkups at the hospital. But the logistical headaches of practicing telemedicine across state lines include trying to reconcile varying requirements for medical licensing.

Mr. Begue hopes in the future that some of these state requirements could be relaxed, which might also make it easier to enroll more people from across the country in clinical trials and encourage more collaboration between cancer centers.

“COVID taught us we have to be more forward thinking and prepared for crises,” Mr. Raine said. “In the future we need to be ready for when – not if – the next crisis comes along – although we’re not out of this one yet.”

Mr. Raine and Mr. Begue did not report any disclosures.

When the Winship Cancer Institute at Emory University, Atlanta, faced off against the pandemic in the spring of 2020, it opened a COVID urgent care clinic for Winship oncology patients who had a confirmed or suspected case of COVID, symptoms or a higher risk for the virus. The urgent care clinic, located in a relatively isolated bay of an infusion center, facilitated segregating COVID-suspected patients from other cancer patients while waiting for their polymerase chain reaction test results to show if they were COVID positive.

A strict triage system was also employed to make sure that the right patients were coming in to the new clinic and not those who either could be managed safely at home or were clinically unstable and belonged in the hospital, said Caleb Raine, PA-C, an oncology physician assistant and bone marrow transplant specialist at Winship. Mr. Raine, who manages the COVID urgent care clinic, shared his experience of “innovations worth keeping” from the pandemic for oncology practices during a panel discussion at the Journal of the Advanced Practitioner in Oncology annual conference, held online Oct. 7.

Telephonic triage was conducted by advanced practice providers (APPs) or nurses using an algorithm Mr. Raine developed incorporating COVID exposure with symptoms such as fever or loss of taste or smell. In order to promote consistency in admissions, he made the final decisions about which patients were brought into the clinic for evaluations, services such as supportive care or infusions, or to address cancer symptoms.

Mr. Raine said the triage process helped to enhance communication with other clinical teams at Winship. He hopes to preserve a strict approach to triaging in future program development, including a 14-bed immediate care center, projected to open next spring, building on experience with the COVID urgent care center. It will offer services similar to a day hospital for cancer patients but be open 24 hours with more capabilities than urgent care. It will target those with emergent needs or who otherwise might require a trip to the ED and provide care for those recently discharged from the hospital in need of follow-up.
 

Remote monitoring

Another conference speaker, Aaron Begue, MS, RN, CNP, vice president for advanced practice providers at Memorial Sloan Kettering Cancer Center in New York, described a pandemic telemedicine intervention for cancer patients implemented by MSKCC during the pandemic. Prior to in-person contact with the care team, patients were asked to complete a questionnaire on their symptoms using MSKCC’s secure online patient portal, MyMSK.

If symptom alerts reached a critical, color-coded threshold, it triggered a nurse or APP from MSKCC to contact the patient at home, typically by phone. APPs also did remote monitoring, including uploaded data from portable home pulse oximeters. A similar symptom tracker was later adapted for monitoring cancer symptoms.

Some APPs took turns working from their own home collecting data needed for inpatient visits and uploading it into the medical record. This helped to deploy clinical teams more efficiently and accommodate some staff who were at high risk of infection because of existing health conditions or quarantined for positive test results.

“We were able to flex our staffing,” Mr. Begue said. Even spending a day staffing a vaccination clinic could provide a break from the intensity of COVID care on the front lines. “All of us are still trying to figure out how to manage staff stress and burnout,” he added, but flexible scheduling seems to be an important strategy.

Early on, things like the crowds coming out in the evening to cheer for New York’s health care workers had a big impact for staff, showing the community’s support. “Later, when public schools were shut down, we worked with two of them to use their outdoor play areas for staff respite – places to sit down outside undisturbed and relax,” he said.

At the height of the COVID surge in New York, telemedicine was an essential component of care, but when it started to recede, Mr. Begue found that a lot of patients wanted in-person visits again. “We had assumed that telemedicine would be the wave of the future and cancer patients would love it,” he said. “We still do thousands of telemedicine visits, but they are no longer the majority.”

MSKCC also does remote telemonitoring visits with patients who live in other states but want to come to New York for surgeries or other procedures or yearly checkups at the hospital. But the logistical headaches of practicing telemedicine across state lines include trying to reconcile varying requirements for medical licensing.

Mr. Begue hopes in the future that some of these state requirements could be relaxed, which might also make it easier to enroll more people from across the country in clinical trials and encourage more collaboration between cancer centers.

“COVID taught us we have to be more forward thinking and prepared for crises,” Mr. Raine said. “In the future we need to be ready for when – not if – the next crisis comes along – although we’re not out of this one yet.”

Mr. Raine and Mr. Begue did not report any disclosures.