The use of digital tools among physicians has markedly risen since 2016, with telehealth visits and remote patient monitoring making the greatest strides in usage, an American Medical Association report shows.

In 2019, 28% of physicians used televisits/virtual visits, up from 14% in 2016, while remote monitoring and management for improved care rose to 22% in 2019, an increase from 13% in 2016, according to the AMA report, released in February 2020. The report, which surveyed 1,359 doctors, includes responses from 672 primary care physicians and 687 specialists.

Remote monitoring for efficiency, meanwhile, grew to 16% in 2019 from 12% in 2016. Remote monitoring for efficiency pertains to smart versions of common clinical devices such as thermometers, blood pressure cuffs, and scales that automatically enter readings in the record. Remote monitoring for improved care refers to mobile applications and devices used for daily measurement of vital signs such as weight, blood pressure, blood glucose.

Adoption of other digital tools by physicians have also grown, including clinical decision support, which climbed to 37% in 2019 from 28% in 2016 and patient engagement tools, which rose to 33% in 2019, up from 26% in 2016. Clinical decision support tools pertain to modules used in conjunction with the electronic health record (EHR), or mobile applications integrated with an EHR that can signify changes in patient data, such as weight gain/loss, or change in blood chemistry. Patient engagement tools, meanwhile, refer to solutions that promote patient wellness and active patient participation in their care.

Tools that encompass use of point of care/workflow enhancement increased to 47% in 2019, from 42% in 2016. This area includes communication and sharing of electronic clinical data to consult with specialists, make referrals and/or transitions of care. Tools that address consumer access to their clinical data, meanwhile, rose to 58% in 2019 from 53% in 2016, the highest adoption rate among the digital health tool categories.

Overall, more physicians see an advantage to digital health solutions than did 3 years ago. More primary care physicians and specialists in 2019 reported a “definite advantage” to digital tools enhancing care of patients than in 2016. Doctors who see no advantage to such tools are trending downward and are concentrated to those age 50 and older, according to the report.

Solo-practice physicians are slowly increasing their use of digital health tools. In 2016, solo physicians reported using an average of 1.5 digital tools, which in 2019 increased to an average of 2.2 digital tools. Small practices with between one and three doctors used an average of 1.4 tools in 2016, which rose to an average of 2.2 tools in 2019, the report found. PCPs used slightly more digital tools, compared with specialists, in both 2016 and 2019.

Female doctors are slightly ahead of their male counterparts when it comes to digital health tools. In 2019, female physicians used an average of 2.6 digital tools, up from 1.9 in 2016. Male doctors used an average of 2.4 tools in 2019, compared with 1.9 tools in 2016.

For the physicians surveyed, the most important factor associated with usage was that digital tools were covered by malpractice insurance, followed by the importance of data privacy/security ensured by the EHR vendor, and that the tools were well integrated with the EHR. Other important factors included that data security was ensured by the practice or hospital, that doctors were reimbursed for their time spent using digital tools, and that the tools were supported by the EHR vendor.

Regarding the top motivator for doctors to use digital tools, 51% of physicians in 2019 said improved efficiency was “very important,” up from 48% in 2016. Other top motivators included that digital tools increased safety, improved diagnostic ability, and addressed physician burnout.

In 2019, the demonstration of safety and efficacy in peer-reviewed publications as it relates to digital tools also grew in importance. Of the physicians surveyed, 36% reported that safety and efficacy demonstrated in peer-reviewed publications was “very important,” an increase from 32% in 2016. Other “very important” factors for physicians are that digital tools used are proven to be as good/superior to traditional care, that they are intuitive/require no special training, that they align with the standard of care, and that their safety and efficacy is validated by the Food and Drug Administration.

“The rise of the digital-native physician will have a profound impact on health care and patient outcomes, and will place digital health technologies under pressure to perform according to higher expectations,” AMA board chair Jesse M. Ehrenfeld, MD, PhD, said in a statement. “The AMA survey provides deep insight into the emerging requirements that physicians expect from digital technologies and sets an industry guidepost for understanding what a growing number of physicians require to adopt new technology.”

The survey was derived from the same physician panel used in 2016, provided by WebMD. For the 2019 survey, the basic 2016 survey was followed in wording and question order, with a few variations to remove some questions no longer relevant. The 2019 sample used careful quotas to ensure a sample composition similar to that of 2016, according to the report.

agallegos@mdedge.com

SOURCE: AMA Digital Health Research: Physicians’ motivations and requirements for adopting digital health – Adoption and attitudinal shifts from 2016 to 2019. American Medical Association. February 2020.

The use of digital tools among physicians has markedly risen since 2016, with telehealth visits and remote patient monitoring making the greatest strides in usage, an American Medical Association report shows.

In 2019, 28% of physicians used televisits/virtual visits, up from 14% in 2016, while remote monitoring and management for improved care rose to 22% in 2019, an increase from 13% in 2016, according to the AMA report, released in February 2020. The report, which surveyed 1,359 doctors, includes responses from 672 primary care physicians and 687 specialists.

Remote monitoring for efficiency, meanwhile, grew to 16% in 2019 from 12% in 2016. Remote monitoring for efficiency pertains to smart versions of common clinical devices such as thermometers, blood pressure cuffs, and scales that automatically enter readings in the record. Remote monitoring for improved care refers to mobile applications and devices used for daily measurement of vital signs such as weight, blood pressure, blood glucose.

Adoption of other digital tools by physicians have also grown, including clinical decision support, which climbed to 37% in 2019 from 28% in 2016 and patient engagement tools, which rose to 33% in 2019, up from 26% in 2016. Clinical decision support tools pertain to modules used in conjunction with the electronic health record (EHR), or mobile applications integrated with an EHR that can signify changes in patient data, such as weight gain/loss, or change in blood chemistry. Patient engagement tools, meanwhile, refer to solutions that promote patient wellness and active patient participation in their care.

Tools that encompass use of point of care/workflow enhancement increased to 47% in 2019, from 42% in 2016. This area includes communication and sharing of electronic clinical data to consult with specialists, make referrals and/or transitions of care. Tools that address consumer access to their clinical data, meanwhile, rose to 58% in 2019 from 53% in 2016, the highest adoption rate among the digital health tool categories.

Overall, more physicians see an advantage to digital health solutions than did 3 years ago. More primary care physicians and specialists in 2019 reported a “definite advantage” to digital tools enhancing care of patients than in 2016. Doctors who see no advantage to such tools are trending downward and are concentrated to those age 50 and older, according to the report.

Solo-practice physicians are slowly increasing their use of digital health tools. In 2016, solo physicians reported using an average of 1.5 digital tools, which in 2019 increased to an average of 2.2 digital tools. Small practices with between one and three doctors used an average of 1.4 tools in 2016, which rose to an average of 2.2 tools in 2019, the report found. PCPs used slightly more digital tools, compared with specialists, in both 2016 and 2019.

Female doctors are slightly ahead of their male counterparts when it comes to digital health tools. In 2019, female physicians used an average of 2.6 digital tools, up from 1.9 in 2016. Male doctors used an average of 2.4 tools in 2019, compared with 1.9 tools in 2016.

For the physicians surveyed, the most important factor associated with usage was that digital tools were covered by malpractice insurance, followed by the importance of data privacy/security ensured by the EHR vendor, and that the tools were well integrated with the EHR. Other important factors included that data security was ensured by the practice or hospital, that doctors were reimbursed for their time spent using digital tools, and that the tools were supported by the EHR vendor.

Regarding the top motivator for doctors to use digital tools, 51% of physicians in 2019 said improved efficiency was “very important,” up from 48% in 2016. Other top motivators included that digital tools increased safety, improved diagnostic ability, and addressed physician burnout.

In 2019, the demonstration of safety and efficacy in peer-reviewed publications as it relates to digital tools also grew in importance. Of the physicians surveyed, 36% reported that safety and efficacy demonstrated in peer-reviewed publications was “very important,” an increase from 32% in 2016. Other “very important” factors for physicians are that digital tools used are proven to be as good/superior to traditional care, that they are intuitive/require no special training, that they align with the standard of care, and that their safety and efficacy is validated by the Food and Drug Administration.

“The rise of the digital-native physician will have a profound impact on health care and patient outcomes, and will place digital health technologies under pressure to perform according to higher expectations,” AMA board chair Jesse M. Ehrenfeld, MD, PhD, said in a statement. “The AMA survey provides deep insight into the emerging requirements that physicians expect from digital technologies and sets an industry guidepost for understanding what a growing number of physicians require to adopt new technology.”

The survey was derived from the same physician panel used in 2016, provided by WebMD. For the 2019 survey, the basic 2016 survey was followed in wording and question order, with a few variations to remove some questions no longer relevant. The 2019 sample used careful quotas to ensure a sample composition similar to that of 2016, according to the report.

agallegos@mdedge.com

SOURCE: AMA Digital Health Research: Physicians’ motivations and requirements for adopting digital health – Adoption and attitudinal shifts from 2016 to 2019. American Medical Association. February 2020.

The use of digital tools among physicians has markedly risen since 2016, with telehealth visits and remote patient monitoring making the greatest strides in usage, an American Medical Association report shows.

In 2019, 28% of physicians used televisits/virtual visits, up from 14% in 2016, while remote monitoring and management for improved care rose to 22% in 2019, an increase from 13% in 2016, according to the AMA report, released in February 2020. The report, which surveyed 1,359 doctors, includes responses from 672 primary care physicians and 687 specialists.

Remote monitoring for efficiency, meanwhile, grew to 16% in 2019 from 12% in 2016. Remote monitoring for efficiency pertains to smart versions of common clinical devices such as thermometers, blood pressure cuffs, and scales that automatically enter readings in the record. Remote monitoring for improved care refers to mobile applications and devices used for daily measurement of vital signs such as weight, blood pressure, blood glucose.

Adoption of other digital tools by physicians have also grown, including clinical decision support, which climbed to 37% in 2019 from 28% in 2016 and patient engagement tools, which rose to 33% in 2019, up from 26% in 2016. Clinical decision support tools pertain to modules used in conjunction with the electronic health record (EHR), or mobile applications integrated with an EHR that can signify changes in patient data, such as weight gain/loss, or change in blood chemistry. Patient engagement tools, meanwhile, refer to solutions that promote patient wellness and active patient participation in their care.

Tools that encompass use of point of care/workflow enhancement increased to 47% in 2019, from 42% in 2016. This area includes communication and sharing of electronic clinical data to consult with specialists, make referrals and/or transitions of care. Tools that address consumer access to their clinical data, meanwhile, rose to 58% in 2019 from 53% in 2016, the highest adoption rate among the digital health tool categories.

Overall, more physicians see an advantage to digital health solutions than did 3 years ago. More primary care physicians and specialists in 2019 reported a “definite advantage” to digital tools enhancing care of patients than in 2016. Doctors who see no advantage to such tools are trending downward and are concentrated to those age 50 and older, according to the report.

Solo-practice physicians are slowly increasing their use of digital health tools. In 2016, solo physicians reported using an average of 1.5 digital tools, which in 2019 increased to an average of 2.2 digital tools. Small practices with between one and three doctors used an average of 1.4 tools in 2016, which rose to an average of 2.2 tools in 2019, the report found. PCPs used slightly more digital tools, compared with specialists, in both 2016 and 2019.

Female doctors are slightly ahead of their male counterparts when it comes to digital health tools. In 2019, female physicians used an average of 2.6 digital tools, up from 1.9 in 2016. Male doctors used an average of 2.4 tools in 2019, compared with 1.9 tools in 2016.

For the physicians surveyed, the most important factor associated with usage was that digital tools were covered by malpractice insurance, followed by the importance of data privacy/security ensured by the EHR vendor, and that the tools were well integrated with the EHR. Other important factors included that data security was ensured by the practice or hospital, that doctors were reimbursed for their time spent using digital tools, and that the tools were supported by the EHR vendor.

Regarding the top motivator for doctors to use digital tools, 51% of physicians in 2019 said improved efficiency was “very important,” up from 48% in 2016. Other top motivators included that digital tools increased safety, improved diagnostic ability, and addressed physician burnout.

In 2019, the demonstration of safety and efficacy in peer-reviewed publications as it relates to digital tools also grew in importance. Of the physicians surveyed, 36% reported that safety and efficacy demonstrated in peer-reviewed publications was “very important,” an increase from 32% in 2016. Other “very important” factors for physicians are that digital tools used are proven to be as good/superior to traditional care, that they are intuitive/require no special training, that they align with the standard of care, and that their safety and efficacy is validated by the Food and Drug Administration.

“The rise of the digital-native physician will have a profound impact on health care and patient outcomes, and will place digital health technologies under pressure to perform according to higher expectations,” AMA board chair Jesse M. Ehrenfeld, MD, PhD, said in a statement. “The AMA survey provides deep insight into the emerging requirements that physicians expect from digital technologies and sets an industry guidepost for understanding what a growing number of physicians require to adopt new technology.”

The survey was derived from the same physician panel used in 2016, provided by WebMD. For the 2019 survey, the basic 2016 survey was followed in wording and question order, with a few variations to remove some questions no longer relevant. The 2019 sample used careful quotas to ensure a sample composition similar to that of 2016, according to the report.

agallegos@mdedge.com

SOURCE: AMA Digital Health Research: Physicians’ motivations and requirements for adopting digital health – Adoption and attitudinal shifts from 2016 to 2019. American Medical Association. February 2020.

Federal Practitioner is inviting hematology and oncology health care providers and researchers to contribute to the November 2020 special issue on immuno-oncology. The special issue is produced in cooperation with the Association of VA Hematology/Oncology (AVAHO). The journal is especially interested in new research, case studies, review articles, and patient care program descriptions.

Interested authors can send a brief 2 to 3 sentence abstract to fedprac@mdedge.com by May 29, 2020, or submit a completed article directly into Editorial Manager, a web-based manuscript submission and review system. The updated and complete submission guidelines, including details about the style and format, can be found here:

http://www.mdedge.com/fedprac/page/submission-guidelines

All manuscripts submitted to Federal Practitioner for both special and regular issues will be subject to peer review. Peer reviews are conducted in a double-blind fashion, and the reviewers are asked to comment on the manuscript’s importance, accuracy, relevance, clarity, timeliness, balance, and reference citation. Final decisions on all submitted manuscripts are made by the Editorial Advisory Association Hematology/Oncology special issue advisory board.

Federal Practitioner is inviting hematology and oncology health care providers and researchers to contribute to the November 2020 special issue on immuno-oncology. The special issue is produced in cooperation with the Association of VA Hematology/Oncology (AVAHO). The journal is especially interested in new research, case studies, review articles, and patient care program descriptions.

Interested authors can send a brief 2 to 3 sentence abstract to fedprac@mdedge.com by May 29, 2020, or submit a completed article directly into Editorial Manager, a web-based manuscript submission and review system. The updated and complete submission guidelines, including details about the style and format, can be found here:

http://www.mdedge.com/fedprac/page/submission-guidelines

All manuscripts submitted to Federal Practitioner for both special and regular issues will be subject to peer review. Peer reviews are conducted in a double-blind fashion, and the reviewers are asked to comment on the manuscript’s importance, accuracy, relevance, clarity, timeliness, balance, and reference citation. Final decisions on all submitted manuscripts are made by the Editorial Advisory Association Hematology/Oncology special issue advisory board.

Federal Practitioner is inviting hematology and oncology health care providers and researchers to contribute to the November 2020 special issue on immuno-oncology. The special issue is produced in cooperation with the Association of VA Hematology/Oncology (AVAHO). The journal is especially interested in new research, case studies, review articles, and patient care program descriptions.

Interested authors can send a brief 2 to 3 sentence abstract to fedprac@mdedge.com by May 29, 2020, or submit a completed article directly into Editorial Manager, a web-based manuscript submission and review system. The updated and complete submission guidelines, including details about the style and format, can be found here:

http://www.mdedge.com/fedprac/page/submission-guidelines

All manuscripts submitted to Federal Practitioner for both special and regular issues will be subject to peer review. Peer reviews are conducted in a double-blind fashion, and the reviewers are asked to comment on the manuscript’s importance, accuracy, relevance, clarity, timeliness, balance, and reference citation. Final decisions on all submitted manuscripts are made by the Editorial Advisory Association Hematology/Oncology special issue advisory board.

The Diagnosis: Candidal Intertrigo  

The biopsy confirmed a diagnosis of severe hyperkeratotic candidal intertrigo with no evidence of Hailey-Hailey disease. Hematoxylin and eosin- stained sections demonstrated irregular acanthosis and variable spongiosis. The stratum corneum was predominantly orthokeratotic with overlying psuedohyphae and yeast fungal elements (Figure 1). 

Hyperimmunoglobulinemia E syndrome (HIES), also known as hyper-IgE syndrome or Job syndrome, is a rare immunodeficiency disorder characterized by an eczematous dermatitis-like rash, recurrent skin and lung abscesses, eosinophilia, and elevated serum IgE. Facial asymmetry, prominent forehead, deep-set eyes, broad nose, and roughened facial skin with large pores are characteristic of the sporadic and autosomal-recessive forms. Other common findings include retained primary teeth, hyperextensible joints, and recurrent mucocutaneous candidiasis.¹ 

Although autosomal-dominant and autosomal-recessive inheritance patterns exist, sporadic mutations are the most common cause of HIES.² Several genes have been implicated depending on the inheritance pattern. The majority of autosomal-dominant cases are associated with inactivating STAT3 (signal transducer and activator of transcription 3) mutations, whereas the majority of autosomal-recessive cases are associated with inactivating DOCK8 (dedicator of cytokinesis 8) mutations.¹ Ultimately, all of these mutations lead to an impaired helper T cell (T_H17) response, which is crucial for clearing fungal and extracellular bacterial infections.³  

Skin eruptions typically are the first manifestation of HIES; they appear within the first week to month of life as papulopustular eruptions on the face and scalp and rapidly generalize to the rest of the body, favoring the shoulders, arms, chest, and buttocks. The pustules then coalesce into crusted plaques that resemble atopic dermatitis, frequently with superimposed Staphylococcus aureus infection. On microscopy, the pustules are folliculocentric and often contain eosinophils, whereas the plaques may contain intraepidermal collections of eosinophils.¹ 

Mucocutaneous candidiasis is seen in approximately 60% of HIES cases and is closely linked to STAT3 inactivating mutations.³ Histologically, there is marked acanthosis with neutrophil exocytosis and abundant yeast and pseudohyphal forms within the stratum corneum (Figure 2).⁴ Cutaneous candidal infections typically require both oral and topical antifungal agents to clear the infection.³ Most cases of mucocutaneous candidiasis are caused by Candida albicans; however, other known culprits include Candida glabrata, Candida tropicalis, Candida parapsilosis, and Candida krusei.^5,6 Of note, species identification and antifungal susceptibility studies may be useful in refractory cases, especially with C glabrata, which is known to acquire resistance to azoles, such as fluconazole, with emerging resistance to echinocandins.⁶  

The differential diagnosis of this groin eruption included Hailey-Hailey disease; pemphigus vegetans, Hallopeau type; tinea cruris; and inverse psoriasis. Hailey-Hailey disease can be complicated by a superimposed candidal infection with similar clinical features, and biopsy may be required for definitive diagnosis. Hailey-Hailey disease typically presents with macerated fissured plaques that resemble macerated tissue paper with red fissures (Figure 3). Biopsy confirms full-thickness acantholysis resembling a dilapidated brick wall with minimal dyskeratosis.¹ Pemphigus vegetans is a localized variant of pemphigus vulgaris with a predilection for flexural surfaces. The lesions progress to vegetating erosive plaques.⁴ The Hallopeau type often is studded with pustules and typically remains more localized than the Neumann type. Direct immunofluorescence demonstrates intercellular deposition of IgG and C3, and routine sections characteristically show pseudoepitheliomatous hyperplasia with intraepidermal eosinophilic microabscesses.^1,4 Tinea cruris is characterized by erythematous annular lesions with raised scaly borders spreading down the inner thighs.⁷ The epidermis is variably spongiotic with parakeratosis, and neutrophils often present in a layered stratum corneum with basketweave keratin above a layer of more compact and eosinophilic keratin. Fungal stains, such as periodic acid-Schiff, will highlight the fungal hyphae within the stratum corneum. The inguinal folds are a typical location for inverse psoriasis, which generally appears as thin, sharply demarcated, shiny red plaques with less scale than plaque psoriasis.¹ Psoriasiform hyperplasia with a diminished granular layer and tortuous papillary dermal vessels would be expected histologically.¹ 

The Diagnosis: Candidal Intertrigo  

The biopsy confirmed a diagnosis of severe hyperkeratotic candidal intertrigo with no evidence of Hailey-Hailey disease. Hematoxylin and eosin- stained sections demonstrated irregular acanthosis and variable spongiosis. The stratum corneum was predominantly orthokeratotic with overlying psuedohyphae and yeast fungal elements (Figure 1). 

Hyperimmunoglobulinemia E syndrome (HIES), also known as hyper-IgE syndrome or Job syndrome, is a rare immunodeficiency disorder characterized by an eczematous dermatitis-like rash, recurrent skin and lung abscesses, eosinophilia, and elevated serum IgE. Facial asymmetry, prominent forehead, deep-set eyes, broad nose, and roughened facial skin with large pores are characteristic of the sporadic and autosomal-recessive forms. Other common findings include retained primary teeth, hyperextensible joints, and recurrent mucocutaneous candidiasis.¹ 

Although autosomal-dominant and autosomal-recessive inheritance patterns exist, sporadic mutations are the most common cause of HIES.² Several genes have been implicated depending on the inheritance pattern. The majority of autosomal-dominant cases are associated with inactivating STAT3 (signal transducer and activator of transcription 3) mutations, whereas the majority of autosomal-recessive cases are associated with inactivating DOCK8 (dedicator of cytokinesis 8) mutations.¹ Ultimately, all of these mutations lead to an impaired helper T cell (T_H17) response, which is crucial for clearing fungal and extracellular bacterial infections.³  

Skin eruptions typically are the first manifestation of HIES; they appear within the first week to month of life as papulopustular eruptions on the face and scalp and rapidly generalize to the rest of the body, favoring the shoulders, arms, chest, and buttocks. The pustules then coalesce into crusted plaques that resemble atopic dermatitis, frequently with superimposed Staphylococcus aureus infection. On microscopy, the pustules are folliculocentric and often contain eosinophils, whereas the plaques may contain intraepidermal collections of eosinophils.¹ 

Mucocutaneous candidiasis is seen in approximately 60% of HIES cases and is closely linked to STAT3 inactivating mutations.³ Histologically, there is marked acanthosis with neutrophil exocytosis and abundant yeast and pseudohyphal forms within the stratum corneum (Figure 2).⁴ Cutaneous candidal infections typically require both oral and topical antifungal agents to clear the infection.³ Most cases of mucocutaneous candidiasis are caused by Candida albicans; however, other known culprits include Candida glabrata, Candida tropicalis, Candida parapsilosis, and Candida krusei.^5,6 Of note, species identification and antifungal susceptibility studies may be useful in refractory cases, especially with C glabrata, which is known to acquire resistance to azoles, such as fluconazole, with emerging resistance to echinocandins.⁶  

The differential diagnosis of this groin eruption included Hailey-Hailey disease; pemphigus vegetans, Hallopeau type; tinea cruris; and inverse psoriasis. Hailey-Hailey disease can be complicated by a superimposed candidal infection with similar clinical features, and biopsy may be required for definitive diagnosis. Hailey-Hailey disease typically presents with macerated fissured plaques that resemble macerated tissue paper with red fissures (Figure 3). Biopsy confirms full-thickness acantholysis resembling a dilapidated brick wall with minimal dyskeratosis.¹ Pemphigus vegetans is a localized variant of pemphigus vulgaris with a predilection for flexural surfaces. The lesions progress to vegetating erosive plaques.⁴ The Hallopeau type often is studded with pustules and typically remains more localized than the Neumann type. Direct immunofluorescence demonstrates intercellular deposition of IgG and C3, and routine sections characteristically show pseudoepitheliomatous hyperplasia with intraepidermal eosinophilic microabscesses.^1,4 Tinea cruris is characterized by erythematous annular lesions with raised scaly borders spreading down the inner thighs.⁷ The epidermis is variably spongiotic with parakeratosis, and neutrophils often present in a layered stratum corneum with basketweave keratin above a layer of more compact and eosinophilic keratin. Fungal stains, such as periodic acid-Schiff, will highlight the fungal hyphae within the stratum corneum. The inguinal folds are a typical location for inverse psoriasis, which generally appears as thin, sharply demarcated, shiny red plaques with less scale than plaque psoriasis.¹ Psoriasiform hyperplasia with a diminished granular layer and tortuous papillary dermal vessels would be expected histologically.¹ 

The Diagnosis: Candidal Intertrigo  

The biopsy confirmed a diagnosis of severe hyperkeratotic candidal intertrigo with no evidence of Hailey-Hailey disease. Hematoxylin and eosin- stained sections demonstrated irregular acanthosis and variable spongiosis. The stratum corneum was predominantly orthokeratotic with overlying psuedohyphae and yeast fungal elements (Figure 1). 

Hyperimmunoglobulinemia E syndrome (HIES), also known as hyper-IgE syndrome or Job syndrome, is a rare immunodeficiency disorder characterized by an eczematous dermatitis-like rash, recurrent skin and lung abscesses, eosinophilia, and elevated serum IgE. Facial asymmetry, prominent forehead, deep-set eyes, broad nose, and roughened facial skin with large pores are characteristic of the sporadic and autosomal-recessive forms. Other common findings include retained primary teeth, hyperextensible joints, and recurrent mucocutaneous candidiasis.¹ 

Although autosomal-dominant and autosomal-recessive inheritance patterns exist, sporadic mutations are the most common cause of HIES.² Several genes have been implicated depending on the inheritance pattern. The majority of autosomal-dominant cases are associated with inactivating STAT3 (signal transducer and activator of transcription 3) mutations, whereas the majority of autosomal-recessive cases are associated with inactivating DOCK8 (dedicator of cytokinesis 8) mutations.¹ Ultimately, all of these mutations lead to an impaired helper T cell (T_H17) response, which is crucial for clearing fungal and extracellular bacterial infections.³  

Skin eruptions typically are the first manifestation of HIES; they appear within the first week to month of life as papulopustular eruptions on the face and scalp and rapidly generalize to the rest of the body, favoring the shoulders, arms, chest, and buttocks. The pustules then coalesce into crusted plaques that resemble atopic dermatitis, frequently with superimposed Staphylococcus aureus infection. On microscopy, the pustules are folliculocentric and often contain eosinophils, whereas the plaques may contain intraepidermal collections of eosinophils.¹ 

Mucocutaneous candidiasis is seen in approximately 60% of HIES cases and is closely linked to STAT3 inactivating mutations.³ Histologically, there is marked acanthosis with neutrophil exocytosis and abundant yeast and pseudohyphal forms within the stratum corneum (Figure 2).⁴ Cutaneous candidal infections typically require both oral and topical antifungal agents to clear the infection.³ Most cases of mucocutaneous candidiasis are caused by Candida albicans; however, other known culprits include Candida glabrata, Candida tropicalis, Candida parapsilosis, and Candida krusei.^5,6 Of note, species identification and antifungal susceptibility studies may be useful in refractory cases, especially with C glabrata, which is known to acquire resistance to azoles, such as fluconazole, with emerging resistance to echinocandins.⁶  

The differential diagnosis of this groin eruption included Hailey-Hailey disease; pemphigus vegetans, Hallopeau type; tinea cruris; and inverse psoriasis. Hailey-Hailey disease can be complicated by a superimposed candidal infection with similar clinical features, and biopsy may be required for definitive diagnosis. Hailey-Hailey disease typically presents with macerated fissured plaques that resemble macerated tissue paper with red fissures (Figure 3). Biopsy confirms full-thickness acantholysis resembling a dilapidated brick wall with minimal dyskeratosis.¹ Pemphigus vegetans is a localized variant of pemphigus vulgaris with a predilection for flexural surfaces. The lesions progress to vegetating erosive plaques.⁴ The Hallopeau type often is studded with pustules and typically remains more localized than the Neumann type. Direct immunofluorescence demonstrates intercellular deposition of IgG and C3, and routine sections characteristically show pseudoepitheliomatous hyperplasia with intraepidermal eosinophilic microabscesses.^1,4 Tinea cruris is characterized by erythematous annular lesions with raised scaly borders spreading down the inner thighs.⁷ The epidermis is variably spongiotic with parakeratosis, and neutrophils often present in a layered stratum corneum with basketweave keratin above a layer of more compact and eosinophilic keratin. Fungal stains, such as periodic acid-Schiff, will highlight the fungal hyphae within the stratum corneum. The inguinal folds are a typical location for inverse psoriasis, which generally appears as thin, sharply demarcated, shiny red plaques with less scale than plaque psoriasis.¹ Psoriasiform hyperplasia with a diminished granular layer and tortuous papillary dermal vessels would be expected histologically.¹ 

To the Editor:

The use of sunless tanners has become an alternative for individuals who wish to have tan skin without exposure to UV radiation.¹ We present a case of a patient who experienced persistent hyperpigmented patches on the hands months after the use of a sunless tanner containing dihydroxyacetone (DHA), a carbohydrate that reacts with amino acids in the stratum corneum to produce pigments called melanoidins. The hyperpigmentation caused by DHA is due to the Maillard reaction, which is the nonenzymatic glycation of amino groups of proteins by the carbonyl groups of sugar.² Many sunless tanners contain DHA at varying concentrations. Dermatologists should be aware of the benefits and potential side effects of these alternative products so that they can appropriately counsel patients.

A 20-year-old woman with no history of skin disease presented for evaluation of hyperpigmented patches on the dorsal hands of several months’ duration. Physical examination revealed ill-defined hyperpigmented patches on the dorsal fingers without associated scale or erythema (Figure 1). She had a remote history of Hodgkin lymphoma treated with chemotherapy and was in remission for 5 years prior to the current presentation. Her hematologists referred her to dermatology for evaluation, as they did not believe the patches could be related to her chemotherapy given that she had completed the treatment years before.

Products with DHA only confer a sun protection factor of approximately 3⁴; although patients may appear tan, they have no actual decreased risk for sunburn after use. Reports have shown that the use of sunless tanners containing DHA can alter the appearance of melanocytic lesions clinically and has caused pseudochromhidrosis on the palms.^3,5,6 A study performed on a human keratinocyte cell line, HaCaT, showed that DHA can induce DNA damage, cell-cycle block, and apoptosis.⁷ In addition, as described in our case, patients may experience prolonged hyperpigmentation after use.

This case demonstrates the potential for persistent hyperpigmentation months after the use of sunless tanners containing DHA. Asking patients specific questions regarding their history of tanning product use is essential in identifying the pathology. Although a skin biopsy may not be strictly indicated, it may aid diagnosis, especially when the history is unclear. As more dermatologists support the use of sunless tanner, we must be aware of this possible outcome, especially on more cosmetically sensitive areas such as the fingers in this patient. Clinicians should be aware that the US Food and Drug Administration recommends avoiding contact with mucous membranes when applying products containing DHA and also recommends use of a test spot prior to treating the entire body with the product.⁸ Patients must not only be educated on the benefits of using sunless tanners but on the potential side effects with use of these products as well.

To the Editor:

The use of sunless tanners has become an alternative for individuals who wish to have tan skin without exposure to UV radiation.¹ We present a case of a patient who experienced persistent hyperpigmented patches on the hands months after the use of a sunless tanner containing dihydroxyacetone (DHA), a carbohydrate that reacts with amino acids in the stratum corneum to produce pigments called melanoidins. The hyperpigmentation caused by DHA is due to the Maillard reaction, which is the nonenzymatic glycation of amino groups of proteins by the carbonyl groups of sugar.² Many sunless tanners contain DHA at varying concentrations. Dermatologists should be aware of the benefits and potential side effects of these alternative products so that they can appropriately counsel patients.

A 20-year-old woman with no history of skin disease presented for evaluation of hyperpigmented patches on the dorsal hands of several months’ duration. Physical examination revealed ill-defined hyperpigmented patches on the dorsal fingers without associated scale or erythema (Figure 1). She had a remote history of Hodgkin lymphoma treated with chemotherapy and was in remission for 5 years prior to the current presentation. Her hematologists referred her to dermatology for evaluation, as they did not believe the patches could be related to her chemotherapy given that she had completed the treatment years before.

Products with DHA only confer a sun protection factor of approximately 3⁴; although patients may appear tan, they have no actual decreased risk for sunburn after use. Reports have shown that the use of sunless tanners containing DHA can alter the appearance of melanocytic lesions clinically and has caused pseudochromhidrosis on the palms.^3,5,6 A study performed on a human keratinocyte cell line, HaCaT, showed that DHA can induce DNA damage, cell-cycle block, and apoptosis.⁷ In addition, as described in our case, patients may experience prolonged hyperpigmentation after use.

This case demonstrates the potential for persistent hyperpigmentation months after the use of sunless tanners containing DHA. Asking patients specific questions regarding their history of tanning product use is essential in identifying the pathology. Although a skin biopsy may not be strictly indicated, it may aid diagnosis, especially when the history is unclear. As more dermatologists support the use of sunless tanner, we must be aware of this possible outcome, especially on more cosmetically sensitive areas such as the fingers in this patient. Clinicians should be aware that the US Food and Drug Administration recommends avoiding contact with mucous membranes when applying products containing DHA and also recommends use of a test spot prior to treating the entire body with the product.⁸ Patients must not only be educated on the benefits of using sunless tanners but on the potential side effects with use of these products as well.

To the Editor:

The use of sunless tanners has become an alternative for individuals who wish to have tan skin without exposure to UV radiation.¹ We present a case of a patient who experienced persistent hyperpigmented patches on the hands months after the use of a sunless tanner containing dihydroxyacetone (DHA), a carbohydrate that reacts with amino acids in the stratum corneum to produce pigments called melanoidins. The hyperpigmentation caused by DHA is due to the Maillard reaction, which is the nonenzymatic glycation of amino groups of proteins by the carbonyl groups of sugar.² Many sunless tanners contain DHA at varying concentrations. Dermatologists should be aware of the benefits and potential side effects of these alternative products so that they can appropriately counsel patients.

A 20-year-old woman with no history of skin disease presented for evaluation of hyperpigmented patches on the dorsal hands of several months’ duration. Physical examination revealed ill-defined hyperpigmented patches on the dorsal fingers without associated scale or erythema (Figure 1). She had a remote history of Hodgkin lymphoma treated with chemotherapy and was in remission for 5 years prior to the current presentation. Her hematologists referred her to dermatology for evaluation, as they did not believe the patches could be related to her chemotherapy given that she had completed the treatment years before.

Products with DHA only confer a sun protection factor of approximately 3⁴; although patients may appear tan, they have no actual decreased risk for sunburn after use. Reports have shown that the use of sunless tanners containing DHA can alter the appearance of melanocytic lesions clinically and has caused pseudochromhidrosis on the palms.^3,5,6 A study performed on a human keratinocyte cell line, HaCaT, showed that DHA can induce DNA damage, cell-cycle block, and apoptosis.⁷ In addition, as described in our case, patients may experience prolonged hyperpigmentation after use.

This case demonstrates the potential for persistent hyperpigmentation months after the use of sunless tanners containing DHA. Asking patients specific questions regarding their history of tanning product use is essential in identifying the pathology. Although a skin biopsy may not be strictly indicated, it may aid diagnosis, especially when the history is unclear. As more dermatologists support the use of sunless tanner, we must be aware of this possible outcome, especially on more cosmetically sensitive areas such as the fingers in this patient. Clinicians should be aware that the US Food and Drug Administration recommends avoiding contact with mucous membranes when applying products containing DHA and also recommends use of a test spot prior to treating the entire body with the product.⁸ Patients must not only be educated on the benefits of using sunless tanners but on the potential side effects with use of these products as well.

To the Editor:

Pseudoepitheliomatous hyperplasia (PEH) is an uncommon type of reactive epidermal proliferation that can occur from a variety of causes, including an underlying infection, inflammation, neoplastic condition, or trauma induced from tattooing.¹ Diagnosis can be challenging and requires clinicopathologic correlation, as PEH can mimic malignancy on histopathology.^2-4 Histologically, PEH shows irregular hyperplasia of the epidermis and adnexal epithelium, elongation of the rete ridges, and extension of the reactive proliferation into the dermis. Absence of cytologic atypia is key to the diagnosis of PEH, helping to distinguish it from squamous cell carcinoma and keratoacanthoma. Clinically, patients typically present with well-demarcated, erythematous, scaly plaques or nodules in reactive areas, which can be symptomatically pruritic.

A 48-year-old woman presented with scaly and crusted verrucous plaques of 2 months’ duration that were isolated to the areas of purple pigment within a tattoo on the right lower leg. The patient reported pruritus in the affected areas that occurred immediately after obtaining the tattoo, which was her first and only tattoo. She denied any pertinent medical history, including an absence of immunosuppression and autoimmune or chronic inflammatory diseases.

Physical examination revealed scaly and crusted plaques isolated to areas of purple tattoo pigment (Figure 1). Areas of red, green, black, and blue pigmentation within the tattoo were uninvolved. With the initial suspicion of allergic contact dermatitis, two 6-mm punch biopsies were taken from adjacent linear plaques on the right leg for histology and tissue culture. Histopathologic evaluation revealed dermal tattoo pigment with overlying PEH and was negative for signs of infection (Figure 2). Infectious stains such as periodic acid–Schiff, Grocott-Gomori methenamine-silver, and Gram stains were performed and found to be negative. In addition, culture for mycobacteria came back negative. Prurigo was on the differential; however, histopathologic changes were more compatible with a PEH reaction to the tattoo.

An increase in the popularity of tattooing has led to more reports of various tattoo skin reactions.^4-6 The differential diagnosis is broad for tattoo reactions and includes granulomatous inflammation, sarcoidosis, psoriasis (Köbner phenomenon), allergic contact dermatitis, lichen planus, morphealike reactions, squamous cell carcinoma, and keratoacanthoma,⁵ which makes clinicopathologic correlation essential for accurate diagnosis. Our case demonstrated the characteristic epithelial hyperplasia in the absence of cytologic atypia. In addition, the presence of mixed dermal inflammation histologically was noted in our patient.

We report an unusual case of PEH occurring secondary to purple tattoo pigment. Our report also demonstrates the clinical and symptomatic improvement of PEH that can be achieved through the use of intralesional corticosteroid therapy. Our patient represents a case of PEH reactive to tattooing with purple ink. Further research to elucidate the precise pathogenesis of PEH tattoo reactions would be helpful in identifying high-risk patients and determining the most efficacious treatments.

To the Editor:

Pseudoepitheliomatous hyperplasia (PEH) is an uncommon type of reactive epidermal proliferation that can occur from a variety of causes, including an underlying infection, inflammation, neoplastic condition, or trauma induced from tattooing.¹ Diagnosis can be challenging and requires clinicopathologic correlation, as PEH can mimic malignancy on histopathology.^2-4 Histologically, PEH shows irregular hyperplasia of the epidermis and adnexal epithelium, elongation of the rete ridges, and extension of the reactive proliferation into the dermis. Absence of cytologic atypia is key to the diagnosis of PEH, helping to distinguish it from squamous cell carcinoma and keratoacanthoma. Clinically, patients typically present with well-demarcated, erythematous, scaly plaques or nodules in reactive areas, which can be symptomatically pruritic.

A 48-year-old woman presented with scaly and crusted verrucous plaques of 2 months’ duration that were isolated to the areas of purple pigment within a tattoo on the right lower leg. The patient reported pruritus in the affected areas that occurred immediately after obtaining the tattoo, which was her first and only tattoo. She denied any pertinent medical history, including an absence of immunosuppression and autoimmune or chronic inflammatory diseases.

Physical examination revealed scaly and crusted plaques isolated to areas of purple tattoo pigment (Figure 1). Areas of red, green, black, and blue pigmentation within the tattoo were uninvolved. With the initial suspicion of allergic contact dermatitis, two 6-mm punch biopsies were taken from adjacent linear plaques on the right leg for histology and tissue culture. Histopathologic evaluation revealed dermal tattoo pigment with overlying PEH and was negative for signs of infection (Figure 2). Infectious stains such as periodic acid–Schiff, Grocott-Gomori methenamine-silver, and Gram stains were performed and found to be negative. In addition, culture for mycobacteria came back negative. Prurigo was on the differential; however, histopathologic changes were more compatible with a PEH reaction to the tattoo.

An increase in the popularity of tattooing has led to more reports of various tattoo skin reactions.^4-6 The differential diagnosis is broad for tattoo reactions and includes granulomatous inflammation, sarcoidosis, psoriasis (Köbner phenomenon), allergic contact dermatitis, lichen planus, morphealike reactions, squamous cell carcinoma, and keratoacanthoma,⁵ which makes clinicopathologic correlation essential for accurate diagnosis. Our case demonstrated the characteristic epithelial hyperplasia in the absence of cytologic atypia. In addition, the presence of mixed dermal inflammation histologically was noted in our patient.

We report an unusual case of PEH occurring secondary to purple tattoo pigment. Our report also demonstrates the clinical and symptomatic improvement of PEH that can be achieved through the use of intralesional corticosteroid therapy. Our patient represents a case of PEH reactive to tattooing with purple ink. Further research to elucidate the precise pathogenesis of PEH tattoo reactions would be helpful in identifying high-risk patients and determining the most efficacious treatments.

To the Editor:

Pseudoepitheliomatous hyperplasia (PEH) is an uncommon type of reactive epidermal proliferation that can occur from a variety of causes, including an underlying infection, inflammation, neoplastic condition, or trauma induced from tattooing.¹ Diagnosis can be challenging and requires clinicopathologic correlation, as PEH can mimic malignancy on histopathology.^2-4 Histologically, PEH shows irregular hyperplasia of the epidermis and adnexal epithelium, elongation of the rete ridges, and extension of the reactive proliferation into the dermis. Absence of cytologic atypia is key to the diagnosis of PEH, helping to distinguish it from squamous cell carcinoma and keratoacanthoma. Clinically, patients typically present with well-demarcated, erythematous, scaly plaques or nodules in reactive areas, which can be symptomatically pruritic.

A 48-year-old woman presented with scaly and crusted verrucous plaques of 2 months’ duration that were isolated to the areas of purple pigment within a tattoo on the right lower leg. The patient reported pruritus in the affected areas that occurred immediately after obtaining the tattoo, which was her first and only tattoo. She denied any pertinent medical history, including an absence of immunosuppression and autoimmune or chronic inflammatory diseases.

Physical examination revealed scaly and crusted plaques isolated to areas of purple tattoo pigment (Figure 1). Areas of red, green, black, and blue pigmentation within the tattoo were uninvolved. With the initial suspicion of allergic contact dermatitis, two 6-mm punch biopsies were taken from adjacent linear plaques on the right leg for histology and tissue culture. Histopathologic evaluation revealed dermal tattoo pigment with overlying PEH and was negative for signs of infection (Figure 2). Infectious stains such as periodic acid–Schiff, Grocott-Gomori methenamine-silver, and Gram stains were performed and found to be negative. In addition, culture for mycobacteria came back negative. Prurigo was on the differential; however, histopathologic changes were more compatible with a PEH reaction to the tattoo.

An increase in the popularity of tattooing has led to more reports of various tattoo skin reactions.^4-6 The differential diagnosis is broad for tattoo reactions and includes granulomatous inflammation, sarcoidosis, psoriasis (Köbner phenomenon), allergic contact dermatitis, lichen planus, morphealike reactions, squamous cell carcinoma, and keratoacanthoma,⁵ which makes clinicopathologic correlation essential for accurate diagnosis. Our case demonstrated the characteristic epithelial hyperplasia in the absence of cytologic atypia. In addition, the presence of mixed dermal inflammation histologically was noted in our patient.

We report an unusual case of PEH occurring secondary to purple tattoo pigment. Our report also demonstrates the clinical and symptomatic improvement of PEH that can be achieved through the use of intralesional corticosteroid therapy. Our patient represents a case of PEH reactive to tattooing with purple ink. Further research to elucidate the precise pathogenesis of PEH tattoo reactions would be helpful in identifying high-risk patients and determining the most efficacious treatments.

Over the past decade gynecologic oncology surgeons have increasingly adopted the technique of sentinel lymph node (SLN) biopsy to stage endometrial cancer. This is supported by evidence that selective removal of the few lymph nodes which are the first to drain the uterus can accurately detect metastatic disease, sparing the patient a complete lymphadenectomy and its associated risks, such as lymphedema.¹ The proposed benefits of SLN biopsy are not just its ability to spare the patient removal of dozens of unnecessary lymph nodes, but also the ability to improve upon the detection of previously unrecognized nodal metastases in locations not routinely sampled by lymphadenectomy and by identifying very-low-volume metastatic disease. This is beneficial only, however, if that previously overlooked low-volume disease is clinically significant.

Courtesy Dr. Emma Rossi

When pathologists evaluate lymph nodes as part of conventional lymphadenectomy, they typically bivalve the lymph node and evaluate with hematoxylin and eosin (H&E) stains. This technique is capable of detecting metastatic lesions greater than 2 mm, but can miss low-volume disease. In contrast, pathologists process SLNs with much finer sectioning (no greater than 2 mm), and, if the node is larger than 4 mm, they will section it perpendicular to the long axis in a bread-loaf fashion. It is not feasible to perform this ultrasectioning on the large numbers of lymph nodes of a complete lymphadenectomy specimen, but when applied to an SLN it allows pathologists to detect much smaller metastatic foci, the so-called “micrometastases” that are between 0.2 and 2 mm in size, and which typically arise in the subcapsular region of the node. The graphic depicts how a traditional longitudinal cut (a) might miss the micrometastasis that could be identified on the finer perpendicular cuts of ultra-sectioning (b). In addition to the ultrasectioning of the node into smaller slices, the pathologist performs additional immunohistochemistry stains for cytokeratin on sentinel nodes which appear negative on preliminary H&E stains. This allows the pathologist to identify even smaller clusters of malignant cells that are less than 0.2 mm, or individual cancer cells, so-called “isolated tumor cells” (ITCs) as shown in the photo. Most SLN series identify that approximately half of their “positive” lymph nodes are low-volume disease (micrometastases and ITCs). ITCs make up the majority of these cases, typically three-quarters.

Courtesy Dr. J. Kish

Clinicians might be reassured by the discovery of low-volume metastatic disease, perceiving that the added attention afforded by the SLN approach helped them to identify metastases that might otherwise have been missed and therefore not treated. This is because node-positive (stage IIIC) disease is not cured by surgery or radiation alone and requires the addition of chemotherapy for survival benefit.² Alternatively, there is no clear survival benefit derived from treating stage I high/intermediate cancers with chemotherapy, and therefore, the prescription of chemotherapy hinges upon reliable identification of extrauterine disease on pathology.³

It would make sense that if SLNs are more effective in identifying metastatic disease, clinicians who practice SLN biopsy would identify it more of the time. This appears to be the case with a trend towards upstaging in patients who undergo SLN biopsy, compared with those undergoing complete lymphadenectomy.⁴ It should also follow that if this increased detection of metastatic disease was clinically relevant, we would observe a corresponding improvement in survival outcomes. If not, then the additional identification of low-volume disease may not be value added: imparting toxicity of adjuvant therapy without survival benefit.

Micrometastases (foci sized 0.2-2 mm) are not a new phenomenon to the SLN era. Low-volume lesions were occasionally detected with routine nodal processing and H&E stains. Attention wasn’t paid to nodal volume categorization in pathology reports prior to the SLN era. These were usually reported collectively as stage IIIC disease. It would make sense to continue to approach micrometastases in a manner similar to what we have always done, recognizing that it may represent a continuum of nodal macrometastases. In contrast, ITCs are rarely detected with routine pathologic processing. Perhaps they are less within a continuum of nodal metastases, and more within the continuum of lymphovascular space invasion. We know that ITCs are significantly associated with the cofinding of this uterine phenomenon, which itself is considered a significant risk factor for local recurrence.⁵

Series have consistently shown the outcomes of women with ITCs to be favorable, compared with those with micrometastases or macrometastases.^5,6 However, most retrospective series that evaluated the outcomes of patients with respect to volume of metastatic disease have high rates of treatment of ITCs with chemotherapy, radiotherapy, or both.⁶ This may mask and confuse whether there is any intrinsically favorable prognostic virtue of ITCs, compared with larger metastatic foci. When ITCs are untreated, it would appear that the rates and patterns of recurrence appear similar to those with negative SLNs, with the caveat that these series all include small numbers.^5,7 This would suggest that women with ITCs do not need additional therapy beyond what would be prescribed for their uterine risk factors.

Further supporting the notion that ITCs have more favorable prognosis is that, while SLN biopsy is associated with a higher detection of nodal metastatic disease, it is not necessarily associated with improved survival when compared with complete lymphadenectomy in retrospective series.⁸ This suggests that finding and treating ITCs may not positively affect outcomes. Or possibly it is a result of inadequate statistical power to show a small benefit should one exist. It is especially difficult to differentiate micrometastases and ITCs with respect to treatment outcomes. Given that ITCs make up the majority of low-volume nodal disease detected through the SLN technique, any potential benefit of increased capture and treatment of the more substantial micrometastases is not likely to be captured. As a result, most series tend to lump patients with micrometastases with those with ITCs in their analysis of patient outcomes. This may be a mistake.

Clearly more research needs to be performed to definitively address the clinical significance of ITCs. While it would be ideal to conduct a prospective trial in which patients with ITCs are randomized to therapy or observation, in reality the scope of such a trial makes it impractical. ITCs are detected in only approximately 5% of all the patients with endometrial cancer, and given that outcomes for this group are, in general, good, it would require enrollment of tens of thousands of patients to establish a statistically satisfactory result. Therefore it is likely that we will need to rely on the results of large retrospective, population-based, observational series to determine if the identification and treatment of ITCs adds value and superior outcomes to patients. In addition, we are making leaps in better understanding the molecular profile of endometrial cancers and how we might incorporate this data with histology and staging results to create treatment algorithms, much like what has been developed for breast cancer. This is likely where the future lies in interpreting the results of staging. In the meantime, it seems reasonable to collect the data regarding volume of metastatic disease including the presence of ITCs, making shared treatment decisions with the patient regarding the addition of adjuvant therapy, recognizing that we lack data that support a benefit for the patient for treatment of ITCs in a manner that differs from treatment of the uterine factors.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no conflicts of interest to declare. Email her at obnews@mdedge.com.

References

1. Lancet Oncol. 2017 Mar;18(3):384-92.

2. J Clin Oncol. 2006 Jan 1;24(1):36-44.

3. J Clin Oncol. 2019 Jul 20;37(21):1810-8.

4. Clin Transl Oncol. 2019. doi: 10.1007/s12094-019-02249-x.

5. Gynecol Oncol. 2017 Aug;146(2):240-6.

6. Ann Surg Oncol. 2016 May;23(5):1653-9.

7. Gynecol Oncol. 2019 Jun;153(3):496-9.

8. Gynecol Oncol. 2018 Nov;151(2):235-42.

Over the past decade gynecologic oncology surgeons have increasingly adopted the technique of sentinel lymph node (SLN) biopsy to stage endometrial cancer. This is supported by evidence that selective removal of the few lymph nodes which are the first to drain the uterus can accurately detect metastatic disease, sparing the patient a complete lymphadenectomy and its associated risks, such as lymphedema.¹ The proposed benefits of SLN biopsy are not just its ability to spare the patient removal of dozens of unnecessary lymph nodes, but also the ability to improve upon the detection of previously unrecognized nodal metastases in locations not routinely sampled by lymphadenectomy and by identifying very-low-volume metastatic disease. This is beneficial only, however, if that previously overlooked low-volume disease is clinically significant.

Courtesy Dr. Emma Rossi

When pathologists evaluate lymph nodes as part of conventional lymphadenectomy, they typically bivalve the lymph node and evaluate with hematoxylin and eosin (H&E) stains. This technique is capable of detecting metastatic lesions greater than 2 mm, but can miss low-volume disease. In contrast, pathologists process SLNs with much finer sectioning (no greater than 2 mm), and, if the node is larger than 4 mm, they will section it perpendicular to the long axis in a bread-loaf fashion. It is not feasible to perform this ultrasectioning on the large numbers of lymph nodes of a complete lymphadenectomy specimen, but when applied to an SLN it allows pathologists to detect much smaller metastatic foci, the so-called “micrometastases” that are between 0.2 and 2 mm in size, and which typically arise in the subcapsular region of the node. The graphic depicts how a traditional longitudinal cut (a) might miss the micrometastasis that could be identified on the finer perpendicular cuts of ultra-sectioning (b). In addition to the ultrasectioning of the node into smaller slices, the pathologist performs additional immunohistochemistry stains for cytokeratin on sentinel nodes which appear negative on preliminary H&E stains. This allows the pathologist to identify even smaller clusters of malignant cells that are less than 0.2 mm, or individual cancer cells, so-called “isolated tumor cells” (ITCs) as shown in the photo. Most SLN series identify that approximately half of their “positive” lymph nodes are low-volume disease (micrometastases and ITCs). ITCs make up the majority of these cases, typically three-quarters.

Courtesy Dr. J. Kish

Clinicians might be reassured by the discovery of low-volume metastatic disease, perceiving that the added attention afforded by the SLN approach helped them to identify metastases that might otherwise have been missed and therefore not treated. This is because node-positive (stage IIIC) disease is not cured by surgery or radiation alone and requires the addition of chemotherapy for survival benefit.² Alternatively, there is no clear survival benefit derived from treating stage I high/intermediate cancers with chemotherapy, and therefore, the prescription of chemotherapy hinges upon reliable identification of extrauterine disease on pathology.³

It would make sense that if SLNs are more effective in identifying metastatic disease, clinicians who practice SLN biopsy would identify it more of the time. This appears to be the case with a trend towards upstaging in patients who undergo SLN biopsy, compared with those undergoing complete lymphadenectomy.⁴ It should also follow that if this increased detection of metastatic disease was clinically relevant, we would observe a corresponding improvement in survival outcomes. If not, then the additional identification of low-volume disease may not be value added: imparting toxicity of adjuvant therapy without survival benefit.

Micrometastases (foci sized 0.2-2 mm) are not a new phenomenon to the SLN era. Low-volume lesions were occasionally detected with routine nodal processing and H&E stains. Attention wasn’t paid to nodal volume categorization in pathology reports prior to the SLN era. These were usually reported collectively as stage IIIC disease. It would make sense to continue to approach micrometastases in a manner similar to what we have always done, recognizing that it may represent a continuum of nodal macrometastases. In contrast, ITCs are rarely detected with routine pathologic processing. Perhaps they are less within a continuum of nodal metastases, and more within the continuum of lymphovascular space invasion. We know that ITCs are significantly associated with the cofinding of this uterine phenomenon, which itself is considered a significant risk factor for local recurrence.⁵

Series have consistently shown the outcomes of women with ITCs to be favorable, compared with those with micrometastases or macrometastases.^5,6 However, most retrospective series that evaluated the outcomes of patients with respect to volume of metastatic disease have high rates of treatment of ITCs with chemotherapy, radiotherapy, or both.⁶ This may mask and confuse whether there is any intrinsically favorable prognostic virtue of ITCs, compared with larger metastatic foci. When ITCs are untreated, it would appear that the rates and patterns of recurrence appear similar to those with negative SLNs, with the caveat that these series all include small numbers.^5,7 This would suggest that women with ITCs do not need additional therapy beyond what would be prescribed for their uterine risk factors.

Further supporting the notion that ITCs have more favorable prognosis is that, while SLN biopsy is associated with a higher detection of nodal metastatic disease, it is not necessarily associated with improved survival when compared with complete lymphadenectomy in retrospective series.⁸ This suggests that finding and treating ITCs may not positively affect outcomes. Or possibly it is a result of inadequate statistical power to show a small benefit should one exist. It is especially difficult to differentiate micrometastases and ITCs with respect to treatment outcomes. Given that ITCs make up the majority of low-volume nodal disease detected through the SLN technique, any potential benefit of increased capture and treatment of the more substantial micrometastases is not likely to be captured. As a result, most series tend to lump patients with micrometastases with those with ITCs in their analysis of patient outcomes. This may be a mistake.

Clearly more research needs to be performed to definitively address the clinical significance of ITCs. While it would be ideal to conduct a prospective trial in which patients with ITCs are randomized to therapy or observation, in reality the scope of such a trial makes it impractical. ITCs are detected in only approximately 5% of all the patients with endometrial cancer, and given that outcomes for this group are, in general, good, it would require enrollment of tens of thousands of patients to establish a statistically satisfactory result. Therefore it is likely that we will need to rely on the results of large retrospective, population-based, observational series to determine if the identification and treatment of ITCs adds value and superior outcomes to patients. In addition, we are making leaps in better understanding the molecular profile of endometrial cancers and how we might incorporate this data with histology and staging results to create treatment algorithms, much like what has been developed for breast cancer. This is likely where the future lies in interpreting the results of staging. In the meantime, it seems reasonable to collect the data regarding volume of metastatic disease including the presence of ITCs, making shared treatment decisions with the patient regarding the addition of adjuvant therapy, recognizing that we lack data that support a benefit for the patient for treatment of ITCs in a manner that differs from treatment of the uterine factors.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no conflicts of interest to declare. Email her at obnews@mdedge.com.

References

1. Lancet Oncol. 2017 Mar;18(3):384-92.

2. J Clin Oncol. 2006 Jan 1;24(1):36-44.

3. J Clin Oncol. 2019 Jul 20;37(21):1810-8.

4. Clin Transl Oncol. 2019. doi: 10.1007/s12094-019-02249-x.

5. Gynecol Oncol. 2017 Aug;146(2):240-6.

6. Ann Surg Oncol. 2016 May;23(5):1653-9.

7. Gynecol Oncol. 2019 Jun;153(3):496-9.

8. Gynecol Oncol. 2018 Nov;151(2):235-42.

Over the past decade gynecologic oncology surgeons have increasingly adopted the technique of sentinel lymph node (SLN) biopsy to stage endometrial cancer. This is supported by evidence that selective removal of the few lymph nodes which are the first to drain the uterus can accurately detect metastatic disease, sparing the patient a complete lymphadenectomy and its associated risks, such as lymphedema.¹ The proposed benefits of SLN biopsy are not just its ability to spare the patient removal of dozens of unnecessary lymph nodes, but also the ability to improve upon the detection of previously unrecognized nodal metastases in locations not routinely sampled by lymphadenectomy and by identifying very-low-volume metastatic disease. This is beneficial only, however, if that previously overlooked low-volume disease is clinically significant.

Courtesy Dr. Emma Rossi

When pathologists evaluate lymph nodes as part of conventional lymphadenectomy, they typically bivalve the lymph node and evaluate with hematoxylin and eosin (H&E) stains. This technique is capable of detecting metastatic lesions greater than 2 mm, but can miss low-volume disease. In contrast, pathologists process SLNs with much finer sectioning (no greater than 2 mm), and, if the node is larger than 4 mm, they will section it perpendicular to the long axis in a bread-loaf fashion. It is not feasible to perform this ultrasectioning on the large numbers of lymph nodes of a complete lymphadenectomy specimen, but when applied to an SLN it allows pathologists to detect much smaller metastatic foci, the so-called “micrometastases” that are between 0.2 and 2 mm in size, and which typically arise in the subcapsular region of the node. The graphic depicts how a traditional longitudinal cut (a) might miss the micrometastasis that could be identified on the finer perpendicular cuts of ultra-sectioning (b). In addition to the ultrasectioning of the node into smaller slices, the pathologist performs additional immunohistochemistry stains for cytokeratin on sentinel nodes which appear negative on preliminary H&E stains. This allows the pathologist to identify even smaller clusters of malignant cells that are less than 0.2 mm, or individual cancer cells, so-called “isolated tumor cells” (ITCs) as shown in the photo. Most SLN series identify that approximately half of their “positive” lymph nodes are low-volume disease (micrometastases and ITCs). ITCs make up the majority of these cases, typically three-quarters.

Courtesy Dr. J. Kish

Clinicians might be reassured by the discovery of low-volume metastatic disease, perceiving that the added attention afforded by the SLN approach helped them to identify metastases that might otherwise have been missed and therefore not treated. This is because node-positive (stage IIIC) disease is not cured by surgery or radiation alone and requires the addition of chemotherapy for survival benefit.² Alternatively, there is no clear survival benefit derived from treating stage I high/intermediate cancers with chemotherapy, and therefore, the prescription of chemotherapy hinges upon reliable identification of extrauterine disease on pathology.³

It would make sense that if SLNs are more effective in identifying metastatic disease, clinicians who practice SLN biopsy would identify it more of the time. This appears to be the case with a trend towards upstaging in patients who undergo SLN biopsy, compared with those undergoing complete lymphadenectomy.⁴ It should also follow that if this increased detection of metastatic disease was clinically relevant, we would observe a corresponding improvement in survival outcomes. If not, then the additional identification of low-volume disease may not be value added: imparting toxicity of adjuvant therapy without survival benefit.

Micrometastases (foci sized 0.2-2 mm) are not a new phenomenon to the SLN era. Low-volume lesions were occasionally detected with routine nodal processing and H&E stains. Attention wasn’t paid to nodal volume categorization in pathology reports prior to the SLN era. These were usually reported collectively as stage IIIC disease. It would make sense to continue to approach micrometastases in a manner similar to what we have always done, recognizing that it may represent a continuum of nodal macrometastases. In contrast, ITCs are rarely detected with routine pathologic processing. Perhaps they are less within a continuum of nodal metastases, and more within the continuum of lymphovascular space invasion. We know that ITCs are significantly associated with the cofinding of this uterine phenomenon, which itself is considered a significant risk factor for local recurrence.⁵

Series have consistently shown the outcomes of women with ITCs to be favorable, compared with those with micrometastases or macrometastases.^5,6 However, most retrospective series that evaluated the outcomes of patients with respect to volume of metastatic disease have high rates of treatment of ITCs with chemotherapy, radiotherapy, or both.⁶ This may mask and confuse whether there is any intrinsically favorable prognostic virtue of ITCs, compared with larger metastatic foci. When ITCs are untreated, it would appear that the rates and patterns of recurrence appear similar to those with negative SLNs, with the caveat that these series all include small numbers.^5,7 This would suggest that women with ITCs do not need additional therapy beyond what would be prescribed for their uterine risk factors.

Further supporting the notion that ITCs have more favorable prognosis is that, while SLN biopsy is associated with a higher detection of nodal metastatic disease, it is not necessarily associated with improved survival when compared with complete lymphadenectomy in retrospective series.⁸ This suggests that finding and treating ITCs may not positively affect outcomes. Or possibly it is a result of inadequate statistical power to show a small benefit should one exist. It is especially difficult to differentiate micrometastases and ITCs with respect to treatment outcomes. Given that ITCs make up the majority of low-volume nodal disease detected through the SLN technique, any potential benefit of increased capture and treatment of the more substantial micrometastases is not likely to be captured. As a result, most series tend to lump patients with micrometastases with those with ITCs in their analysis of patient outcomes. This may be a mistake.

Clearly more research needs to be performed to definitively address the clinical significance of ITCs. While it would be ideal to conduct a prospective trial in which patients with ITCs are randomized to therapy or observation, in reality the scope of such a trial makes it impractical. ITCs are detected in only approximately 5% of all the patients with endometrial cancer, and given that outcomes for this group are, in general, good, it would require enrollment of tens of thousands of patients to establish a statistically satisfactory result. Therefore it is likely that we will need to rely on the results of large retrospective, population-based, observational series to determine if the identification and treatment of ITCs adds value and superior outcomes to patients. In addition, we are making leaps in better understanding the molecular profile of endometrial cancers and how we might incorporate this data with histology and staging results to create treatment algorithms, much like what has been developed for breast cancer. This is likely where the future lies in interpreting the results of staging. In the meantime, it seems reasonable to collect the data regarding volume of metastatic disease including the presence of ITCs, making shared treatment decisions with the patient regarding the addition of adjuvant therapy, recognizing that we lack data that support a benefit for the patient for treatment of ITCs in a manner that differs from treatment of the uterine factors.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no conflicts of interest to declare. Email her at obnews@mdedge.com.

References

1. Lancet Oncol. 2017 Mar;18(3):384-92.

2. J Clin Oncol. 2006 Jan 1;24(1):36-44.

3. J Clin Oncol. 2019 Jul 20;37(21):1810-8.

4. Clin Transl Oncol. 2019. doi: 10.1007/s12094-019-02249-x.

5. Gynecol Oncol. 2017 Aug;146(2):240-6.

6. Ann Surg Oncol. 2016 May;23(5):1653-9.

7. Gynecol Oncol. 2019 Jun;153(3):496-9.

8. Gynecol Oncol. 2018 Nov;151(2):235-42.

The sodium-glucose transporter 2 (SGLT-2) inhibitor ertugliflozin broke ranks with the other drugs in its class and failed to produce statistically significant drops in the both the combined incidence of cardiovascular (CV) death or heart failure hospitalization, and the rate of adverse renal outcomes, in the mandated CV outcomes trial run for ertugliflozin with more than 8,200 patients with type 2 diabetes and established CV disease.

Merck, one of the companies that markets the drug, announced the topline results in a quarterly financial report released on April 28, 2020.

According to the report, the results from the ertugliflozin cardiovascular outcomes trial “achieved its primary endpoint of noninferiority for major adverse CV events (MACE), compared to placebo in patients with type 2 diabetes mellitus and established atherosclerotic CV disease,” but “the key secondary endpoints of superiority” of ertugliflozin, compared with placebo, “for time to the composite of CV death or hospitalization for heart failure, CV death alone, and the composite of renal death, dialysis/transplant or doubling of serum creatinine from baseline were not met.”

However, the report added that, “while not a prespecified hypothesis for statistical testing, a reduction in hospitalization for heart failure was observed” with ertugliflozin treatment, and the report further said that the drug’s safety profile in the trial “was consistent with that reported in previous studies.” The statement closed by saying that detailed results from the trial are scheduled to be presented on June 16, 2020, at the virtual American Diabetes Association’s 80th Scientific Sessions.

These results came from the VERTIS CV (Evaluation of Ertugliflozin EffIcacy and Safety Cardiovascular Outcomes) trial, which researchers said in 2018 had administered at least one investigational dose to 8,238 randomized patients at centers in any of 34 countries during two enrollment periods in 2013-2015 and 2016-2017 (Am Heart J. 2018 Dec;206:11-23). The tested agent, ertugliflozin (Steglatro) received Food and Drug Administration marketing approval late in 2017 for the indication of improving glycemic control in patients with type 2 diabetes.

The FDA mandated cardiovascular outcomes trials for new glycemic control drugs in guidance the agency issued in 2008 (the FDA released in March 2020 a draft of updated guidance on this topic).

Other FDA-approved agents from the SGLT2 inhibitor class include canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance), and all three showed evidence for a statistically significant effect on reducing the incidence of CV disease death and heart failure hospitalizations, as well as renal complications (Can J Diabetes. 2020 Feb;44[1]:61-7). The evidence showing that several SGLT2 drugs have important and consistent effects on endpoints like CV death, heart failure hospitalizations, and renal complications has helped propel this class of agents to the forefront of glycemic control treatments. More recently, one agent from this group, dapagliflozin, also significantly cut the rate of heart failure worsening or CV disease death in patients with heart failure with reduced ejection fraction but without diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008). Based on this evidence, the FDA is currently considering adding a new indication for dapagliflozin that would also label it for use in patients with heart failure with reduced ejection fraction but without diabetes.

mzoler@mdedge.com

The sodium-glucose transporter 2 (SGLT-2) inhibitor ertugliflozin broke ranks with the other drugs in its class and failed to produce statistically significant drops in the both the combined incidence of cardiovascular (CV) death or heart failure hospitalization, and the rate of adverse renal outcomes, in the mandated CV outcomes trial run for ertugliflozin with more than 8,200 patients with type 2 diabetes and established CV disease.

Merck, one of the companies that markets the drug, announced the topline results in a quarterly financial report released on April 28, 2020.

According to the report, the results from the ertugliflozin cardiovascular outcomes trial “achieved its primary endpoint of noninferiority for major adverse CV events (MACE), compared to placebo in patients with type 2 diabetes mellitus and established atherosclerotic CV disease,” but “the key secondary endpoints of superiority” of ertugliflozin, compared with placebo, “for time to the composite of CV death or hospitalization for heart failure, CV death alone, and the composite of renal death, dialysis/transplant or doubling of serum creatinine from baseline were not met.”

However, the report added that, “while not a prespecified hypothesis for statistical testing, a reduction in hospitalization for heart failure was observed” with ertugliflozin treatment, and the report further said that the drug’s safety profile in the trial “was consistent with that reported in previous studies.” The statement closed by saying that detailed results from the trial are scheduled to be presented on June 16, 2020, at the virtual American Diabetes Association’s 80th Scientific Sessions.

These results came from the VERTIS CV (Evaluation of Ertugliflozin EffIcacy and Safety Cardiovascular Outcomes) trial, which researchers said in 2018 had administered at least one investigational dose to 8,238 randomized patients at centers in any of 34 countries during two enrollment periods in 2013-2015 and 2016-2017 (Am Heart J. 2018 Dec;206:11-23). The tested agent, ertugliflozin (Steglatro) received Food and Drug Administration marketing approval late in 2017 for the indication of improving glycemic control in patients with type 2 diabetes.

The FDA mandated cardiovascular outcomes trials for new glycemic control drugs in guidance the agency issued in 2008 (the FDA released in March 2020 a draft of updated guidance on this topic).

Other FDA-approved agents from the SGLT2 inhibitor class include canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance), and all three showed evidence for a statistically significant effect on reducing the incidence of CV disease death and heart failure hospitalizations, as well as renal complications (Can J Diabetes. 2020 Feb;44[1]:61-7). The evidence showing that several SGLT2 drugs have important and consistent effects on endpoints like CV death, heart failure hospitalizations, and renal complications has helped propel this class of agents to the forefront of glycemic control treatments. More recently, one agent from this group, dapagliflozin, also significantly cut the rate of heart failure worsening or CV disease death in patients with heart failure with reduced ejection fraction but without diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008). Based on this evidence, the FDA is currently considering adding a new indication for dapagliflozin that would also label it for use in patients with heart failure with reduced ejection fraction but without diabetes.

mzoler@mdedge.com

The sodium-glucose transporter 2 (SGLT-2) inhibitor ertugliflozin broke ranks with the other drugs in its class and failed to produce statistically significant drops in the both the combined incidence of cardiovascular (CV) death or heart failure hospitalization, and the rate of adverse renal outcomes, in the mandated CV outcomes trial run for ertugliflozin with more than 8,200 patients with type 2 diabetes and established CV disease.

Merck, one of the companies that markets the drug, announced the topline results in a quarterly financial report released on April 28, 2020.

According to the report, the results from the ertugliflozin cardiovascular outcomes trial “achieved its primary endpoint of noninferiority for major adverse CV events (MACE), compared to placebo in patients with type 2 diabetes mellitus and established atherosclerotic CV disease,” but “the key secondary endpoints of superiority” of ertugliflozin, compared with placebo, “for time to the composite of CV death or hospitalization for heart failure, CV death alone, and the composite of renal death, dialysis/transplant or doubling of serum creatinine from baseline were not met.”

However, the report added that, “while not a prespecified hypothesis for statistical testing, a reduction in hospitalization for heart failure was observed” with ertugliflozin treatment, and the report further said that the drug’s safety profile in the trial “was consistent with that reported in previous studies.” The statement closed by saying that detailed results from the trial are scheduled to be presented on June 16, 2020, at the virtual American Diabetes Association’s 80th Scientific Sessions.

These results came from the VERTIS CV (Evaluation of Ertugliflozin EffIcacy and Safety Cardiovascular Outcomes) trial, which researchers said in 2018 had administered at least one investigational dose to 8,238 randomized patients at centers in any of 34 countries during two enrollment periods in 2013-2015 and 2016-2017 (Am Heart J. 2018 Dec;206:11-23). The tested agent, ertugliflozin (Steglatro) received Food and Drug Administration marketing approval late in 2017 for the indication of improving glycemic control in patients with type 2 diabetes.

The FDA mandated cardiovascular outcomes trials for new glycemic control drugs in guidance the agency issued in 2008 (the FDA released in March 2020 a draft of updated guidance on this topic).

Other FDA-approved agents from the SGLT2 inhibitor class include canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance), and all three showed evidence for a statistically significant effect on reducing the incidence of CV disease death and heart failure hospitalizations, as well as renal complications (Can J Diabetes. 2020 Feb;44[1]:61-7). The evidence showing that several SGLT2 drugs have important and consistent effects on endpoints like CV death, heart failure hospitalizations, and renal complications has helped propel this class of agents to the forefront of glycemic control treatments. More recently, one agent from this group, dapagliflozin, also significantly cut the rate of heart failure worsening or CV disease death in patients with heart failure with reduced ejection fraction but without diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008). Based on this evidence, the FDA is currently considering adding a new indication for dapagliflozin that would also label it for use in patients with heart failure with reduced ejection fraction but without diabetes.

mzoler@mdedge.com

The results of two postapproval studies confirm the potential risk of hyperinflation and acute pancreatitis with the Orbera and ReShape liquid-filled intragastric balloon systems used to treat obesity.

The Orbera Intragastric Balloon System is manufactured by Apollo Endosurgery. The ReShape Integrated Dual Balloon System was previously manufactured by ReShape Medical but was acquired by Apollo Endosurgery in December 2018.

In the Orbera postapproval study, 6 of 258 patients (2.3%) experienced balloon hyperinflation, the Food and Drug Administration said today in a letter to health care providers. There were no hyperinflation events detected in the ReShape postapproval study.

Acute pancreatitis was reported in 2 of 159 patients (1.3%) in the ReShape study, with no cases of acute pancreatitis reported in the Orbera study.

No balloon hyperinflation or acute pancreatitis events were reported in the studies the companies submitted to the FDA to gain approval, the agency said.

No deaths were reported in the postapproval studies, though the agency notes that the studies were not powered to detect. However, since Orbera and ReShape were approved in 2015, the FDA has learned of 18 deaths worldwide, including 8 patients in the United States (5 with Orbera and 3 with ReShape).

The FDA issued previous letters to health care providers concerning issues with these devices in June 2018, August 2017, and February 2017.

As of Jan. 1, 2019, Apollo Endosurgery stopped selling the ReShape Balloon. The Orbera balloon remains available.

“The FDA wants to ensure healthcare professionals are aware of the rates of these potential complications observed in the post-approval studies so they can discuss the risks and benefits of weight loss treatments with patients and monitor patients during treatment,” Benjamin Fisher, PhD, director of the Reproductive, Gastro-Renal, Urological, General Hospital Device, and Human Factors Office at the FDA’s Center for Devices and Radiological Health, said in a statement.

“While these devices remain an appropriate treatment option for some patients with obesity, patients should always discuss with their doctors which treatment option is best for them,” said Dr. Fisher.

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

The results of two postapproval studies confirm the potential risk of hyperinflation and acute pancreatitis with the Orbera and ReShape liquid-filled intragastric balloon systems used to treat obesity.

The Orbera Intragastric Balloon System is manufactured by Apollo Endosurgery. The ReShape Integrated Dual Balloon System was previously manufactured by ReShape Medical but was acquired by Apollo Endosurgery in December 2018.

In the Orbera postapproval study, 6 of 258 patients (2.3%) experienced balloon hyperinflation, the Food and Drug Administration said today in a letter to health care providers. There were no hyperinflation events detected in the ReShape postapproval study.

Acute pancreatitis was reported in 2 of 159 patients (1.3%) in the ReShape study, with no cases of acute pancreatitis reported in the Orbera study.

No balloon hyperinflation or acute pancreatitis events were reported in the studies the companies submitted to the FDA to gain approval, the agency said.

No deaths were reported in the postapproval studies, though the agency notes that the studies were not powered to detect. However, since Orbera and ReShape were approved in 2015, the FDA has learned of 18 deaths worldwide, including 8 patients in the United States (5 with Orbera and 3 with ReShape).

The FDA issued previous letters to health care providers concerning issues with these devices in June 2018, August 2017, and February 2017.

As of Jan. 1, 2019, Apollo Endosurgery stopped selling the ReShape Balloon. The Orbera balloon remains available.

“The FDA wants to ensure healthcare professionals are aware of the rates of these potential complications observed in the post-approval studies so they can discuss the risks and benefits of weight loss treatments with patients and monitor patients during treatment,” Benjamin Fisher, PhD, director of the Reproductive, Gastro-Renal, Urological, General Hospital Device, and Human Factors Office at the FDA’s Center for Devices and Radiological Health, said in a statement.

“While these devices remain an appropriate treatment option for some patients with obesity, patients should always discuss with their doctors which treatment option is best for them,” said Dr. Fisher.

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

The results of two postapproval studies confirm the potential risk of hyperinflation and acute pancreatitis with the Orbera and ReShape liquid-filled intragastric balloon systems used to treat obesity.

The Orbera Intragastric Balloon System is manufactured by Apollo Endosurgery. The ReShape Integrated Dual Balloon System was previously manufactured by ReShape Medical but was acquired by Apollo Endosurgery in December 2018.

In the Orbera postapproval study, 6 of 258 patients (2.3%) experienced balloon hyperinflation, the Food and Drug Administration said today in a letter to health care providers. There were no hyperinflation events detected in the ReShape postapproval study.

Acute pancreatitis was reported in 2 of 159 patients (1.3%) in the ReShape study, with no cases of acute pancreatitis reported in the Orbera study.

No balloon hyperinflation or acute pancreatitis events were reported in the studies the companies submitted to the FDA to gain approval, the agency said.

No deaths were reported in the postapproval studies, though the agency notes that the studies were not powered to detect. However, since Orbera and ReShape were approved in 2015, the FDA has learned of 18 deaths worldwide, including 8 patients in the United States (5 with Orbera and 3 with ReShape).

The FDA issued previous letters to health care providers concerning issues with these devices in June 2018, August 2017, and February 2017.

As of Jan. 1, 2019, Apollo Endosurgery stopped selling the ReShape Balloon. The Orbera balloon remains available.

“The FDA wants to ensure healthcare professionals are aware of the rates of these potential complications observed in the post-approval studies so they can discuss the risks and benefits of weight loss treatments with patients and monitor patients during treatment,” Benjamin Fisher, PhD, director of the Reproductive, Gastro-Renal, Urological, General Hospital Device, and Human Factors Office at the FDA’s Center for Devices and Radiological Health, said in a statement.

“While these devices remain an appropriate treatment option for some patients with obesity, patients should always discuss with their doctors which treatment option is best for them,” said Dr. Fisher.

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

Seventy-three. That is the average number of questions asked daily by preschool-aged children.

Children ask questions to make sense of their world, to learn how things work, to verify their safety, and to interact with others. As a physician, a child and adolescent psychiatrist, and a father to 6-year-old twin daughters, I too am asking more questions these days. Both professionally and personally, these questions are prompted by shifts in routines, uncertainty, and anxiety brought on by the ongoing coronavirus disease 2019 (COVID-19) pandemic. In parallel, I find myself reflecting on my twin daughters’ questions; their questions reverberate with my own, and with the increased anxiety and fears of my patients and their parents.

With this in mind, I’d like to share 2 questions related to pediatric anxiety that may sculpt our clinical work—whether with children, adolescents, or adults—as we provide treatment and comfort to our patients during this pandemic of anxiety.

How do parents affect children’s anxiety?

First, children take cues from their parents. Almost a half century ago, child and adolescent psychiatrist Robert Emde, MD, and others, using elegantly designed experimental settings, documented that a mother’s response strongly influences her young son or daughter’s emotional reaction to a stranger, or to new situations.¹ Specifically, very young children were less afraid and interacted more with a stranger and did so more quickly when their mother had a positive (as opposed to neutral or fearful) reaction to the situation.² Further, in these studies, when the parent’s face was partially covered, very young children became more fearful. Taken together, these findings remind us that children actively seek to read the affective states of those who care for them, and use these reactions to anchor their responses to shifts in routine, such as those brought on by the ongoing COVID-19 pandemic.

Second, in reacting to the pandemic, parents model emotional regulation—an important skill that children and adolescents must develop as they experience intense affect and anxiety. As mental health clinicians, we know that emotional regulation is an essential component of mental health, and problems with it are a hallmark characteristic of several disorders, including anxiety disorders. Further, neuroimaging studies over the past decade have demonstrated that the way in which the medial prefrontal cortex and lower limbic structures (eg, the amygdala) are connected shifts from early childhood through adolescence and into early adulthood.³ It is likely that these shifts in functional connectivity are shaped by the environment as well as intrinsic aspects of the patient’s biology, and that these shifts subtend the developmental expression of anxiety, particularly in times of stress.

How should we talk to children about the pandemic?

Trust is not only the scaffold of our therapeutic relationships, but also a critical component of our conversations with children about the pandemic. Having established a trusting relationship prior to talking with children about their anxiety and about the pandemic, we will do well to remember that there is often more to a question than the actual direct interrogative. From a developmental standpoint, children may repeatedly ask the same question because they are struggling to understand an abstract concept, or are unable to make the same implicit causal link that we—as adults—have made. Also, children may ask the same question multiple times as a way of seeking reassurance. Finally, when a child asks her father “How many people are going to die?” she may actually be asking whether her parents, grandparents, or friends will be safe and healthy. Thus, as we talk with children, we must remember that they may be implicitly asking for more than a number, date, or mechanism. We must think about the motivation for their questions vis a vis their specific fears and past experiences.

For children, adolescents, and adults, the anxiety created by the pandemic constantly shifts, is hard-to-define, and pervades their lives. This ensuing chronic variable stress can worsen both physical and mental health.⁴ But, it also creates an opportunity for resiliency which—like the coronavirus—can be contagious.^5,6 Knowing this, I’d like to ask 4 questions, based on David Brooks’ recent Op-Ed in the New York Times⁷:

1. Can we become “softer and wiser” as a result of the pandemic?
2. How can we inoculate our patients against the loneliness and isolation that worsen most psychiatric disorders?
3. How can we “see deeper into [our]selves” to provide comfort to our patients, families, and each other as we confront this viral pandemic of anxiety?
4. Following “social distancing,” how do we rekindle “social trust”?

Seventy-three. That is the average number of questions asked daily by preschool-aged children.

Children ask questions to make sense of their world, to learn how things work, to verify their safety, and to interact with others. As a physician, a child and adolescent psychiatrist, and a father to 6-year-old twin daughters, I too am asking more questions these days. Both professionally and personally, these questions are prompted by shifts in routines, uncertainty, and anxiety brought on by the ongoing coronavirus disease 2019 (COVID-19) pandemic. In parallel, I find myself reflecting on my twin daughters’ questions; their questions reverberate with my own, and with the increased anxiety and fears of my patients and their parents.

With this in mind, I’d like to share 2 questions related to pediatric anxiety that may sculpt our clinical work—whether with children, adolescents, or adults—as we provide treatment and comfort to our patients during this pandemic of anxiety.

How do parents affect children’s anxiety?

First, children take cues from their parents. Almost a half century ago, child and adolescent psychiatrist Robert Emde, MD, and others, using elegantly designed experimental settings, documented that a mother’s response strongly influences her young son or daughter’s emotional reaction to a stranger, or to new situations.¹ Specifically, very young children were less afraid and interacted more with a stranger and did so more quickly when their mother had a positive (as opposed to neutral or fearful) reaction to the situation.² Further, in these studies, when the parent’s face was partially covered, very young children became more fearful. Taken together, these findings remind us that children actively seek to read the affective states of those who care for them, and use these reactions to anchor their responses to shifts in routine, such as those brought on by the ongoing COVID-19 pandemic.

Second, in reacting to the pandemic, parents model emotional regulation—an important skill that children and adolescents must develop as they experience intense affect and anxiety. As mental health clinicians, we know that emotional regulation is an essential component of mental health, and problems with it are a hallmark characteristic of several disorders, including anxiety disorders. Further, neuroimaging studies over the past decade have demonstrated that the way in which the medial prefrontal cortex and lower limbic structures (eg, the amygdala) are connected shifts from early childhood through adolescence and into early adulthood.³ It is likely that these shifts in functional connectivity are shaped by the environment as well as intrinsic aspects of the patient’s biology, and that these shifts subtend the developmental expression of anxiety, particularly in times of stress.

How should we talk to children about the pandemic?

Trust is not only the scaffold of our therapeutic relationships, but also a critical component of our conversations with children about the pandemic. Having established a trusting relationship prior to talking with children about their anxiety and about the pandemic, we will do well to remember that there is often more to a question than the actual direct interrogative. From a developmental standpoint, children may repeatedly ask the same question because they are struggling to understand an abstract concept, or are unable to make the same implicit causal link that we—as adults—have made. Also, children may ask the same question multiple times as a way of seeking reassurance. Finally, when a child asks her father “How many people are going to die?” she may actually be asking whether her parents, grandparents, or friends will be safe and healthy. Thus, as we talk with children, we must remember that they may be implicitly asking for more than a number, date, or mechanism. We must think about the motivation for their questions vis a vis their specific fears and past experiences.

For children, adolescents, and adults, the anxiety created by the pandemic constantly shifts, is hard-to-define, and pervades their lives. This ensuing chronic variable stress can worsen both physical and mental health.⁴ But, it also creates an opportunity for resiliency which—like the coronavirus—can be contagious.^5,6 Knowing this, I’d like to ask 4 questions, based on David Brooks’ recent Op-Ed in the New York Times⁷:

1. Can we become “softer and wiser” as a result of the pandemic?
2. How can we inoculate our patients against the loneliness and isolation that worsen most psychiatric disorders?
3. How can we “see deeper into [our]selves” to provide comfort to our patients, families, and each other as we confront this viral pandemic of anxiety?
4. Following “social distancing,” how do we rekindle “social trust”?

Seventy-three. That is the average number of questions asked daily by preschool-aged children.

Children ask questions to make sense of their world, to learn how things work, to verify their safety, and to interact with others. As a physician, a child and adolescent psychiatrist, and a father to 6-year-old twin daughters, I too am asking more questions these days. Both professionally and personally, these questions are prompted by shifts in routines, uncertainty, and anxiety brought on by the ongoing coronavirus disease 2019 (COVID-19) pandemic. In parallel, I find myself reflecting on my twin daughters’ questions; their questions reverberate with my own, and with the increased anxiety and fears of my patients and their parents.

With this in mind, I’d like to share 2 questions related to pediatric anxiety that may sculpt our clinical work—whether with children, adolescents, or adults—as we provide treatment and comfort to our patients during this pandemic of anxiety.

How do parents affect children’s anxiety?

First, children take cues from their parents. Almost a half century ago, child and adolescent psychiatrist Robert Emde, MD, and others, using elegantly designed experimental settings, documented that a mother’s response strongly influences her young son or daughter’s emotional reaction to a stranger, or to new situations.¹ Specifically, very young children were less afraid and interacted more with a stranger and did so more quickly when their mother had a positive (as opposed to neutral or fearful) reaction to the situation.² Further, in these studies, when the parent’s face was partially covered, very young children became more fearful. Taken together, these findings remind us that children actively seek to read the affective states of those who care for them, and use these reactions to anchor their responses to shifts in routine, such as those brought on by the ongoing COVID-19 pandemic.

Second, in reacting to the pandemic, parents model emotional regulation—an important skill that children and adolescents must develop as they experience intense affect and anxiety. As mental health clinicians, we know that emotional regulation is an essential component of mental health, and problems with it are a hallmark characteristic of several disorders, including anxiety disorders. Further, neuroimaging studies over the past decade have demonstrated that the way in which the medial prefrontal cortex and lower limbic structures (eg, the amygdala) are connected shifts from early childhood through adolescence and into early adulthood.³ It is likely that these shifts in functional connectivity are shaped by the environment as well as intrinsic aspects of the patient’s biology, and that these shifts subtend the developmental expression of anxiety, particularly in times of stress.

How should we talk to children about the pandemic?

Trust is not only the scaffold of our therapeutic relationships, but also a critical component of our conversations with children about the pandemic. Having established a trusting relationship prior to talking with children about their anxiety and about the pandemic, we will do well to remember that there is often more to a question than the actual direct interrogative. From a developmental standpoint, children may repeatedly ask the same question because they are struggling to understand an abstract concept, or are unable to make the same implicit causal link that we—as adults—have made. Also, children may ask the same question multiple times as a way of seeking reassurance. Finally, when a child asks her father “How many people are going to die?” she may actually be asking whether her parents, grandparents, or friends will be safe and healthy. Thus, as we talk with children, we must remember that they may be implicitly asking for more than a number, date, or mechanism. We must think about the motivation for their questions vis a vis their specific fears and past experiences.

For children, adolescents, and adults, the anxiety created by the pandemic constantly shifts, is hard-to-define, and pervades their lives. This ensuing chronic variable stress can worsen both physical and mental health.⁴ But, it also creates an opportunity for resiliency which—like the coronavirus—can be contagious.^5,6 Knowing this, I’d like to ask 4 questions, based on David Brooks’ recent Op-Ed in the New York Times⁷:

1. Can we become “softer and wiser” as a result of the pandemic?
2. How can we inoculate our patients against the loneliness and isolation that worsen most psychiatric disorders?
3. How can we “see deeper into [our]selves” to provide comfort to our patients, families, and each other as we confront this viral pandemic of anxiety?
4. Following “social distancing,” how do we rekindle “social trust”?

The broad use of telemedicine has been a bright spot in the COVID-19 response, but the pandemic is also creating significant disruption as some physicians are furloughed and others consider practice changes.

verbaska_studio/Getty Images

A recent survey of physicians conducted by Merritt Hawkins and The Physicians Foundation examined how physicians are being affected by and responding to the pandemic. The findings are based on completed surveys from 842 physicians. About one-third of respondents are primary care physicians, while two-thirds are surgical, medical, and diagnostic specialists and subspecialists.

The survey shines a light on the rapid adoption of telemedicine, with 48% of physicians respondents reporting that they are now treating patients through telemedicine.

“I think that is purely explainable on the situation that COVID has led to with the desire to see patients remotely, still take care of them, and the fact that at the federal level this was recognized and doctors are being compensated for seeing patients remotely,” Gary Price, MD, a plastic surgeon and president of The Physicians Foundation, said in an interview.

“The Foundation does a study of the nation’s physicians every other year and in 2018, when we asked the same question, only 18% of physicians were using some form of telemedicine,” he added.

And Dr. Price said he thinks the shift to telemedicine is here to stay.

“I think that will be a lasting effect of the pandemic,” he said. “More physicians and more patients will be using telemedicine approaches, I think, from here on out. We will see a shift that persists. I think that’s a good thing. Physicians like it. Patients like it. It won’t replace all in-person visits, certainly, but there are a number of health care visits that could be taken care of quite well with a virtual visit and it saves the patients travel time, time away from work, and I think it can make the physicians’ practice more efficient as well.”

The key to sustainability, he said, will be that private insurers and the Centers for Medicare & Medicaid Services continue to pay for it.

“I think we will have had a good demonstration, not only that it can work, but that it does work and that it can be accomplished without any diminishment in the quality of care that’s delivered,” he said.

But the recent survey also identified a number of employment issues that have arisen during the COVID-19 pandemic. Overall, 18% of respondents who were treating COVID-19 patients and 30% of those not treating COVID-19 patients reported that they had been furloughed or experienced a pay cut. Among respondents, just 38.5% reported that they are seeing COVID-19 patients.

“It is unprecedented to my knowledge in the physician employment sphere,” Dr. Price said. “That was the most surprising thing to me. I think you might be able to explain that by the increasing number of physicians who are employees now of larger health systems and the fact that a big portion of those health systems too, in normal times, involves care that right now no one is able to get to or even wants to be seen for because of the risk, of course, of COVID-19.”

The survey also revealed that some respondents had or were planning a change in practice because of COVID-19: 14% said they had or would seek a different practice, 6% reported they had or would find a job without patient care, 7% said they had or would close their practice temporarily, 5% reported that they had or would retire, and 4% said they had or would leave private practice and seek employment at a hospital.

“The survey represents how they are feeling at the time and it doesn’t mean they will necessarily do that, but if even a portion of doctors did that all at once, we would really aggravate an access problem and what we know is a worsening physician shortage in the country,” he said. “So we are very concerned about that.”

Dr. Price also predicted there would be increased consolidation within the health care system as more smaller, independent practices feel the financial stress of the pandemic.

“I hope that I am wrong about that,” he said. “I think smaller practices offer a very cost-effective solution for high-quality care, and their competition in the marketplace for health care is a good and healthy thing.”

gtwachtman@mdedge.com

The broad use of telemedicine has been a bright spot in the COVID-19 response, but the pandemic is also creating significant disruption as some physicians are furloughed and others consider practice changes.

verbaska_studio/Getty Images

A recent survey of physicians conducted by Merritt Hawkins and The Physicians Foundation examined how physicians are being affected by and responding to the pandemic. The findings are based on completed surveys from 842 physicians. About one-third of respondents are primary care physicians, while two-thirds are surgical, medical, and diagnostic specialists and subspecialists.

The survey shines a light on the rapid adoption of telemedicine, with 48% of physicians respondents reporting that they are now treating patients through telemedicine.

“I think that is purely explainable on the situation that COVID has led to with the desire to see patients remotely, still take care of them, and the fact that at the federal level this was recognized and doctors are being compensated for seeing patients remotely,” Gary Price, MD, a plastic surgeon and president of The Physicians Foundation, said in an interview.

“The Foundation does a study of the nation’s physicians every other year and in 2018, when we asked the same question, only 18% of physicians were using some form of telemedicine,” he added.

And Dr. Price said he thinks the shift to telemedicine is here to stay.

“I think that will be a lasting effect of the pandemic,” he said. “More physicians and more patients will be using telemedicine approaches, I think, from here on out. We will see a shift that persists. I think that’s a good thing. Physicians like it. Patients like it. It won’t replace all in-person visits, certainly, but there are a number of health care visits that could be taken care of quite well with a virtual visit and it saves the patients travel time, time away from work, and I think it can make the physicians’ practice more efficient as well.”

The key to sustainability, he said, will be that private insurers and the Centers for Medicare & Medicaid Services continue to pay for it.

“I think we will have had a good demonstration, not only that it can work, but that it does work and that it can be accomplished without any diminishment in the quality of care that’s delivered,” he said.

But the recent survey also identified a number of employment issues that have arisen during the COVID-19 pandemic. Overall, 18% of respondents who were treating COVID-19 patients and 30% of those not treating COVID-19 patients reported that they had been furloughed or experienced a pay cut. Among respondents, just 38.5% reported that they are seeing COVID-19 patients.

“It is unprecedented to my knowledge in the physician employment sphere,” Dr. Price said. “That was the most surprising thing to me. I think you might be able to explain that by the increasing number of physicians who are employees now of larger health systems and the fact that a big portion of those health systems too, in normal times, involves care that right now no one is able to get to or even wants to be seen for because of the risk, of course, of COVID-19.”

The survey also revealed that some respondents had or were planning a change in practice because of COVID-19: 14% said they had or would seek a different practice, 6% reported they had or would find a job without patient care, 7% said they had or would close their practice temporarily, 5% reported that they had or would retire, and 4% said they had or would leave private practice and seek employment at a hospital.

“The survey represents how they are feeling at the time and it doesn’t mean they will necessarily do that, but if even a portion of doctors did that all at once, we would really aggravate an access problem and what we know is a worsening physician shortage in the country,” he said. “So we are very concerned about that.”

Dr. Price also predicted there would be increased consolidation within the health care system as more smaller, independent practices feel the financial stress of the pandemic.

“I hope that I am wrong about that,” he said. “I think smaller practices offer a very cost-effective solution for high-quality care, and their competition in the marketplace for health care is a good and healthy thing.”

gtwachtman@mdedge.com

The broad use of telemedicine has been a bright spot in the COVID-19 response, but the pandemic is also creating significant disruption as some physicians are furloughed and others consider practice changes.

verbaska_studio/Getty Images

A recent survey of physicians conducted by Merritt Hawkins and The Physicians Foundation examined how physicians are being affected by and responding to the pandemic. The findings are based on completed surveys from 842 physicians. About one-third of respondents are primary care physicians, while two-thirds are surgical, medical, and diagnostic specialists and subspecialists.

The survey shines a light on the rapid adoption of telemedicine, with 48% of physicians respondents reporting that they are now treating patients through telemedicine.

“I think that is purely explainable on the situation that COVID has led to with the desire to see patients remotely, still take care of them, and the fact that at the federal level this was recognized and doctors are being compensated for seeing patients remotely,” Gary Price, MD, a plastic surgeon and president of The Physicians Foundation, said in an interview.

“The Foundation does a study of the nation’s physicians every other year and in 2018, when we asked the same question, only 18% of physicians were using some form of telemedicine,” he added.

And Dr. Price said he thinks the shift to telemedicine is here to stay.

“I think that will be a lasting effect of the pandemic,” he said. “More physicians and more patients will be using telemedicine approaches, I think, from here on out. We will see a shift that persists. I think that’s a good thing. Physicians like it. Patients like it. It won’t replace all in-person visits, certainly, but there are a number of health care visits that could be taken care of quite well with a virtual visit and it saves the patients travel time, time away from work, and I think it can make the physicians’ practice more efficient as well.”

The key to sustainability, he said, will be that private insurers and the Centers for Medicare & Medicaid Services continue to pay for it.

“I think we will have had a good demonstration, not only that it can work, but that it does work and that it can be accomplished without any diminishment in the quality of care that’s delivered,” he said.

But the recent survey also identified a number of employment issues that have arisen during the COVID-19 pandemic. Overall, 18% of respondents who were treating COVID-19 patients and 30% of those not treating COVID-19 patients reported that they had been furloughed or experienced a pay cut. Among respondents, just 38.5% reported that they are seeing COVID-19 patients.

“It is unprecedented to my knowledge in the physician employment sphere,” Dr. Price said. “That was the most surprising thing to me. I think you might be able to explain that by the increasing number of physicians who are employees now of larger health systems and the fact that a big portion of those health systems too, in normal times, involves care that right now no one is able to get to or even wants to be seen for because of the risk, of course, of COVID-19.”

The survey also revealed that some respondents had or were planning a change in practice because of COVID-19: 14% said they had or would seek a different practice, 6% reported they had or would find a job without patient care, 7% said they had or would close their practice temporarily, 5% reported that they had or would retire, and 4% said they had or would leave private practice and seek employment at a hospital.

“The survey represents how they are feeling at the time and it doesn’t mean they will necessarily do that, but if even a portion of doctors did that all at once, we would really aggravate an access problem and what we know is a worsening physician shortage in the country,” he said. “So we are very concerned about that.”

Dr. Price also predicted there would be increased consolidation within the health care system as more smaller, independent practices feel the financial stress of the pandemic.

“I hope that I am wrong about that,” he said. “I think smaller practices offer a very cost-effective solution for high-quality care, and their competition in the marketplace for health care is a good and healthy thing.”

gtwachtman@mdedge.com