To the Editor:

Pityriasis lichenoides is a papulosquamous dermatologic disorder that is characterized by recurrent papules.¹ There is a spectrum of disease in pityriasis lichenoides that includes pityriasis lichenoides et varioliformis acuta (PLEVA) at one end and pityriasis lichenoides chronica at the other. Pityriasis lichenoides et varioliformis acuta is more common in younger individuals and is characterized by erythematous papules that often crust; these lesions resolve over weeks. The lesions of pityriasis lichenoides chronica are characteristically scaly, pink to red-brown papules that tend to resolve over months.¹

Histologically, PLEVA exhibits parakeratosis, interface dermatitis, and a wedge-shaped infiltrate.¹ Necrotic keratinocytes and extravasated erythrocytes also are common features. Additionally, monoclonal T cells may be present in the infiltrate.¹

Febrile ulceronecrotic Mucha-Habermann disease (FUMHD) is a rare and severe variant of PLEVA. Febrile ulceronecrotic Mucha-Habermann disease is characterized by ulceronecrotic lesions, fever, and systemic symptoms.² Herein, we present a case of FUMHD.

A 57-year-old man presented with an eruption of painful lesions involving the face, trunk, arms, legs, and genitalia of 1 month’s duration. The patient denied oral and ocular involvement. He had soreness and swelling of the arms and legs. A prior 12-day course of prednisone prescribed by a community dermatologist failed to improve the rash. A biopsy performed by a community dermatologist was nondiagnostic. The patient denied fever but did report chills. He had no preceding illness and was not taking new medications. On physical examination, the patient was afebrile and normotensive with innumerable deep-seated pustules and crusted ulcerations on the face, palms, soles, trunk, extremities, and penis (Figures 1 and 2). There was a background morbilliform eruption on the trunk. The ocular and oral mucosae were spared. The upper and lower extremities had pitting edema.

The patient’s alanine aminotransaminase and aspartate aminotransaminase levels were elevated at 55 and 51 U/L, respectively. His white blood cell count was within reference range; however, there was an elevated absolute neutrophil count (8.7×10³/μL). No eosinophilia was noted. Laboratory evaluation showed a positive antimitochondrial antibody, and magnetic resonance imaging showed evidence of steatohepatitis. Punch biopsies from both the morbilliform eruption and a deep-seated pustule showed epidermal necrosis, parakeratosis, necrotic keratinocytes, and a lichenoid infiltrate of lymphocytes at the dermoepidermal interface. In the dermis, there was a wedge-shaped superficial and deep, perivascular infiltrate with extravasated erythrocytes (Figures 3 and 4). Tissue Gram stain was negative for bacteria. Varicella-zoster virus and herpes simplex virus immunostains were negative. Direct immunofluorescence showed colloid bodies, as can be seen in lichenoid dermatitis.

At the next clinic visit, the patient reported a fever of 39.4 °C. After reviewing the patient’s histopathology and clinical picture, along with the presence of fever, a final diagnosis of FUMHD was made. The patient was started on an oral regimen of prednisone 80 mg once daily, minocycline 100 mg twice daily, and methotrexate 15 mg weekly. Unna boots (specialized compression wraps) with triamcinolone acetonide ointment 0.1% were placed weekly until the leg edema and ulcerations healed. He was maintained on methotrexate 15 mg weekly and 5 to 10 mg of prednisone once daily. The patient demonstrated residual scarring, with only rare new papulonodules that did not ulcerate when attempts were made to taper his medications. He was followed for nearly 3 years, with a recurrence of symptoms 2 years and 3 months after initial presentation to the academic dermatology clinic.

Febrile ulceronecrotic Mucha-Habermann disease is a rare and severe variant of PLEVA that can present with the rapid appearance of necrotic skin lesions, fever, and systemic manifestations, including pulmonary, gastrointestinal, central nervous system, cardiac, hematologic, and rheumatologic symptoms.^2-4 The evolution from PLEVA to FUMHD ranges from days to weeks, and patientsrarely can have an initial presentation of FUMHD.² The duration of illness has been reported to be 1 to 24 months⁵; however, the length of illness still remains unclear, as many studies of FUMHD are case reports with limited follow-up. Our patient had a disease duration of at least 27 months. The lesions of FUMHD usually are generalized with flexural prominence, and mucosal involvement occurs in approximately one-quarter of cases. Hypertrophic scarring may be seen after the ulcerated lesions heal.² The incidence of FUMHD is higher in men than in women, and it is more common in younger individuals.^2,6 There have been reported fatalities associated with FUMHD, mostly in adults.^2,4

The clinical differential diagnosis for PLEVA includes disseminated herpes zoster, varicella-zoster virus or coxsackievirus infections, lymphomatoid papulosis, angiodestructive lymphoma such as extranodal natural killer/T-cell lymphoma, drug eruption, arthropod bite, erythema multiforme, ecthyma, ecthyma gangrenosum, necrotic folliculitis, and cutaneous small vessel vasculitis. To differentiate between these diagnoses and PLEVA or FUMHD, it is important to take a strong clinical history. For example, for varicella-zoster virus and coxsackievirus infections, exposure history to the viruses and vaccination history for varicella-zoster virus can help elucidate the diagnosis.

Skin biopsy can help differentiate between these entities and PLEVA or FUMHD. The histopathology of a nonulcerated lesion of FUMHD shows parakeratosis, spongiosis, and lymphocyte exocytosis, as well as lymphocytic vasculitis—findings commonly seen in PLEVA. With the ulceronecrotic lesions of FUMHD, epidermal necrosis and ulceration can be seen microscopically.² Although skin biopsy is not absolutely necessary for making the diagnosis of PLEVA, it can be helpful.³ However, given the dramatic and extreme clinical impression with an extensive differential diagnosis that includes disorders ranging from infectious to neoplastic, biopsy of FUMHD with clinicopathologic correlation often is required.

It is important to avoid biopsying ulcerated lesions of FUMHD, as the histopathologic findings are more likely to be nonspecific. Additionally, nonspecific features often are seen with immunohistochemistry; abnormal laboratory testing may be seen in FUMHD, but there is no specific test to diagnose FUMHD.² Finally, a predominantly CD8⁺ cell infiltrate was seen in 4 of 6 cases of FUMHD, with 2 cases showing a mixed infiltrate of CD8⁺ and CD4⁺ cells.^5,7-10

Although no unified diagnostic criterion exists for FUMHD, Nofal et al² proposed criteria comprised of constant features, which are found in every case of FUMHD and can confirm the diagnosis alone, and variable features to help ensure that cases of FUMHD are not missed. The constant features include fever, acute onset of generalized ulceronecrotic papules and plaques, a course that is rapid and progressive (without a tendency for spontaneous resolution), and histopathology that is consistent with PLEVA. The variable features include history of PLEVA, involvement of mucous membranes, and systemic involvement.²

No single unifying treatment modality for all cases of FUMHD has been described. Immunosuppressive drugs (eg, systemic steroids, methotrexate), antibiotics, antivirals, phototherapy, intravenous immunoglobulin, and dapsone have been tried in patients with FUMHD.² Combination therapy with an oral medication such as erythromycin or methotrexate and psoralen plus UVA may be effective for FUMHD.³ Additionally, some authors believe that patients with FUMHD should be treated similar to burn victims with intensive supportive care.²

The etiology of PLEVA is unknown, but it is presumed to be associated with an effector cytotoxic T-cell response to either an infectious agent or a drug.¹¹Three studies have shown that most PLEVA cases (100% [3/3]; 65% [13/20]; and 57% [8/14]) demonstrate T-cell clonality,^12-14 and some have suggested that PLEVA may be a T-cell lymphoproliferative disorder.^12,13 Additionally, in a case report of 2 children with PLEVA who progressed to cutaneous T-cell lymphoma, the authors suggested that PLEVA may be related to nonaggressive cutaneous T-cell lymphoma.¹⁵ Of note, T-cell clonality, often found through the analysis of T-cell receptor gene rearrangement, is not an absolute criterion for determining malignancy, as some benign conditions may have clonality.¹⁶ However, in another study, clonality was found in only 1 of 10 cases of PLEVA, suggesting that PLEVA stems from an inflammatory reaction to infectious or other triggering agents.¹⁷

Four cases of FUMHD with monoclonality have been reported,^4,7,8 and some researchers propose that FUMHD may be a subset of cutaneous T-cell lymphoma.⁷ However, 2 other cases of FUMHD did not show monoclonality of T cells,^5,18 suggesting that FUMHD may represent an inflammatory disorder, rather than a lymphoproliferative process of T cells.¹⁸ Given the controversy surrounding the clonality of FUMHD, T-cell gene rearrangement studies were not performed in our case.

To the Editor:

Pityriasis lichenoides is a papulosquamous dermatologic disorder that is characterized by recurrent papules.¹ There is a spectrum of disease in pityriasis lichenoides that includes pityriasis lichenoides et varioliformis acuta (PLEVA) at one end and pityriasis lichenoides chronica at the other. Pityriasis lichenoides et varioliformis acuta is more common in younger individuals and is characterized by erythematous papules that often crust; these lesions resolve over weeks. The lesions of pityriasis lichenoides chronica are characteristically scaly, pink to red-brown papules that tend to resolve over months.¹

Histologically, PLEVA exhibits parakeratosis, interface dermatitis, and a wedge-shaped infiltrate.¹ Necrotic keratinocytes and extravasated erythrocytes also are common features. Additionally, monoclonal T cells may be present in the infiltrate.¹

Febrile ulceronecrotic Mucha-Habermann disease (FUMHD) is a rare and severe variant of PLEVA. Febrile ulceronecrotic Mucha-Habermann disease is characterized by ulceronecrotic lesions, fever, and systemic symptoms.² Herein, we present a case of FUMHD.

A 57-year-old man presented with an eruption of painful lesions involving the face, trunk, arms, legs, and genitalia of 1 month’s duration. The patient denied oral and ocular involvement. He had soreness and swelling of the arms and legs. A prior 12-day course of prednisone prescribed by a community dermatologist failed to improve the rash. A biopsy performed by a community dermatologist was nondiagnostic. The patient denied fever but did report chills. He had no preceding illness and was not taking new medications. On physical examination, the patient was afebrile and normotensive with innumerable deep-seated pustules and crusted ulcerations on the face, palms, soles, trunk, extremities, and penis (Figures 1 and 2). There was a background morbilliform eruption on the trunk. The ocular and oral mucosae were spared. The upper and lower extremities had pitting edema.

The patient’s alanine aminotransaminase and aspartate aminotransaminase levels were elevated at 55 and 51 U/L, respectively. His white blood cell count was within reference range; however, there was an elevated absolute neutrophil count (8.7×10³/μL). No eosinophilia was noted. Laboratory evaluation showed a positive antimitochondrial antibody, and magnetic resonance imaging showed evidence of steatohepatitis. Punch biopsies from both the morbilliform eruption and a deep-seated pustule showed epidermal necrosis, parakeratosis, necrotic keratinocytes, and a lichenoid infiltrate of lymphocytes at the dermoepidermal interface. In the dermis, there was a wedge-shaped superficial and deep, perivascular infiltrate with extravasated erythrocytes (Figures 3 and 4). Tissue Gram stain was negative for bacteria. Varicella-zoster virus and herpes simplex virus immunostains were negative. Direct immunofluorescence showed colloid bodies, as can be seen in lichenoid dermatitis.

At the next clinic visit, the patient reported a fever of 39.4 °C. After reviewing the patient’s histopathology and clinical picture, along with the presence of fever, a final diagnosis of FUMHD was made. The patient was started on an oral regimen of prednisone 80 mg once daily, minocycline 100 mg twice daily, and methotrexate 15 mg weekly. Unna boots (specialized compression wraps) with triamcinolone acetonide ointment 0.1% were placed weekly until the leg edema and ulcerations healed. He was maintained on methotrexate 15 mg weekly and 5 to 10 mg of prednisone once daily. The patient demonstrated residual scarring, with only rare new papulonodules that did not ulcerate when attempts were made to taper his medications. He was followed for nearly 3 years, with a recurrence of symptoms 2 years and 3 months after initial presentation to the academic dermatology clinic.

Febrile ulceronecrotic Mucha-Habermann disease is a rare and severe variant of PLEVA that can present with the rapid appearance of necrotic skin lesions, fever, and systemic manifestations, including pulmonary, gastrointestinal, central nervous system, cardiac, hematologic, and rheumatologic symptoms.^2-4 The evolution from PLEVA to FUMHD ranges from days to weeks, and patientsrarely can have an initial presentation of FUMHD.² The duration of illness has been reported to be 1 to 24 months⁵; however, the length of illness still remains unclear, as many studies of FUMHD are case reports with limited follow-up. Our patient had a disease duration of at least 27 months. The lesions of FUMHD usually are generalized with flexural prominence, and mucosal involvement occurs in approximately one-quarter of cases. Hypertrophic scarring may be seen after the ulcerated lesions heal.² The incidence of FUMHD is higher in men than in women, and it is more common in younger individuals.^2,6 There have been reported fatalities associated with FUMHD, mostly in adults.^2,4

The clinical differential diagnosis for PLEVA includes disseminated herpes zoster, varicella-zoster virus or coxsackievirus infections, lymphomatoid papulosis, angiodestructive lymphoma such as extranodal natural killer/T-cell lymphoma, drug eruption, arthropod bite, erythema multiforme, ecthyma, ecthyma gangrenosum, necrotic folliculitis, and cutaneous small vessel vasculitis. To differentiate between these diagnoses and PLEVA or FUMHD, it is important to take a strong clinical history. For example, for varicella-zoster virus and coxsackievirus infections, exposure history to the viruses and vaccination history for varicella-zoster virus can help elucidate the diagnosis.

Skin biopsy can help differentiate between these entities and PLEVA or FUMHD. The histopathology of a nonulcerated lesion of FUMHD shows parakeratosis, spongiosis, and lymphocyte exocytosis, as well as lymphocytic vasculitis—findings commonly seen in PLEVA. With the ulceronecrotic lesions of FUMHD, epidermal necrosis and ulceration can be seen microscopically.² Although skin biopsy is not absolutely necessary for making the diagnosis of PLEVA, it can be helpful.³ However, given the dramatic and extreme clinical impression with an extensive differential diagnosis that includes disorders ranging from infectious to neoplastic, biopsy of FUMHD with clinicopathologic correlation often is required.

It is important to avoid biopsying ulcerated lesions of FUMHD, as the histopathologic findings are more likely to be nonspecific. Additionally, nonspecific features often are seen with immunohistochemistry; abnormal laboratory testing may be seen in FUMHD, but there is no specific test to diagnose FUMHD.² Finally, a predominantly CD8⁺ cell infiltrate was seen in 4 of 6 cases of FUMHD, with 2 cases showing a mixed infiltrate of CD8⁺ and CD4⁺ cells.^5,7-10

Although no unified diagnostic criterion exists for FUMHD, Nofal et al² proposed criteria comprised of constant features, which are found in every case of FUMHD and can confirm the diagnosis alone, and variable features to help ensure that cases of FUMHD are not missed. The constant features include fever, acute onset of generalized ulceronecrotic papules and plaques, a course that is rapid and progressive (without a tendency for spontaneous resolution), and histopathology that is consistent with PLEVA. The variable features include history of PLEVA, involvement of mucous membranes, and systemic involvement.²

No single unifying treatment modality for all cases of FUMHD has been described. Immunosuppressive drugs (eg, systemic steroids, methotrexate), antibiotics, antivirals, phototherapy, intravenous immunoglobulin, and dapsone have been tried in patients with FUMHD.² Combination therapy with an oral medication such as erythromycin or methotrexate and psoralen plus UVA may be effective for FUMHD.³ Additionally, some authors believe that patients with FUMHD should be treated similar to burn victims with intensive supportive care.²

The etiology of PLEVA is unknown, but it is presumed to be associated with an effector cytotoxic T-cell response to either an infectious agent or a drug.¹¹Three studies have shown that most PLEVA cases (100% [3/3]; 65% [13/20]; and 57% [8/14]) demonstrate T-cell clonality,^12-14 and some have suggested that PLEVA may be a T-cell lymphoproliferative disorder.^12,13 Additionally, in a case report of 2 children with PLEVA who progressed to cutaneous T-cell lymphoma, the authors suggested that PLEVA may be related to nonaggressive cutaneous T-cell lymphoma.¹⁵ Of note, T-cell clonality, often found through the analysis of T-cell receptor gene rearrangement, is not an absolute criterion for determining malignancy, as some benign conditions may have clonality.¹⁶ However, in another study, clonality was found in only 1 of 10 cases of PLEVA, suggesting that PLEVA stems from an inflammatory reaction to infectious or other triggering agents.¹⁷

Four cases of FUMHD with monoclonality have been reported,^4,7,8 and some researchers propose that FUMHD may be a subset of cutaneous T-cell lymphoma.⁷ However, 2 other cases of FUMHD did not show monoclonality of T cells,^5,18 suggesting that FUMHD may represent an inflammatory disorder, rather than a lymphoproliferative process of T cells.¹⁸ Given the controversy surrounding the clonality of FUMHD, T-cell gene rearrangement studies were not performed in our case.

To the Editor:

Pityriasis lichenoides is a papulosquamous dermatologic disorder that is characterized by recurrent papules.¹ There is a spectrum of disease in pityriasis lichenoides that includes pityriasis lichenoides et varioliformis acuta (PLEVA) at one end and pityriasis lichenoides chronica at the other. Pityriasis lichenoides et varioliformis acuta is more common in younger individuals and is characterized by erythematous papules that often crust; these lesions resolve over weeks. The lesions of pityriasis lichenoides chronica are characteristically scaly, pink to red-brown papules that tend to resolve over months.¹

Histologically, PLEVA exhibits parakeratosis, interface dermatitis, and a wedge-shaped infiltrate.¹ Necrotic keratinocytes and extravasated erythrocytes also are common features. Additionally, monoclonal T cells may be present in the infiltrate.¹

Febrile ulceronecrotic Mucha-Habermann disease (FUMHD) is a rare and severe variant of PLEVA. Febrile ulceronecrotic Mucha-Habermann disease is characterized by ulceronecrotic lesions, fever, and systemic symptoms.² Herein, we present a case of FUMHD.

A 57-year-old man presented with an eruption of painful lesions involving the face, trunk, arms, legs, and genitalia of 1 month’s duration. The patient denied oral and ocular involvement. He had soreness and swelling of the arms and legs. A prior 12-day course of prednisone prescribed by a community dermatologist failed to improve the rash. A biopsy performed by a community dermatologist was nondiagnostic. The patient denied fever but did report chills. He had no preceding illness and was not taking new medications. On physical examination, the patient was afebrile and normotensive with innumerable deep-seated pustules and crusted ulcerations on the face, palms, soles, trunk, extremities, and penis (Figures 1 and 2). There was a background morbilliform eruption on the trunk. The ocular and oral mucosae were spared. The upper and lower extremities had pitting edema.

The patient’s alanine aminotransaminase and aspartate aminotransaminase levels were elevated at 55 and 51 U/L, respectively. His white blood cell count was within reference range; however, there was an elevated absolute neutrophil count (8.7×10³/μL). No eosinophilia was noted. Laboratory evaluation showed a positive antimitochondrial antibody, and magnetic resonance imaging showed evidence of steatohepatitis. Punch biopsies from both the morbilliform eruption and a deep-seated pustule showed epidermal necrosis, parakeratosis, necrotic keratinocytes, and a lichenoid infiltrate of lymphocytes at the dermoepidermal interface. In the dermis, there was a wedge-shaped superficial and deep, perivascular infiltrate with extravasated erythrocytes (Figures 3 and 4). Tissue Gram stain was negative for bacteria. Varicella-zoster virus and herpes simplex virus immunostains were negative. Direct immunofluorescence showed colloid bodies, as can be seen in lichenoid dermatitis.

At the next clinic visit, the patient reported a fever of 39.4 °C. After reviewing the patient’s histopathology and clinical picture, along with the presence of fever, a final diagnosis of FUMHD was made. The patient was started on an oral regimen of prednisone 80 mg once daily, minocycline 100 mg twice daily, and methotrexate 15 mg weekly. Unna boots (specialized compression wraps) with triamcinolone acetonide ointment 0.1% were placed weekly until the leg edema and ulcerations healed. He was maintained on methotrexate 15 mg weekly and 5 to 10 mg of prednisone once daily. The patient demonstrated residual scarring, with only rare new papulonodules that did not ulcerate when attempts were made to taper his medications. He was followed for nearly 3 years, with a recurrence of symptoms 2 years and 3 months after initial presentation to the academic dermatology clinic.

Febrile ulceronecrotic Mucha-Habermann disease is a rare and severe variant of PLEVA that can present with the rapid appearance of necrotic skin lesions, fever, and systemic manifestations, including pulmonary, gastrointestinal, central nervous system, cardiac, hematologic, and rheumatologic symptoms.^2-4 The evolution from PLEVA to FUMHD ranges from days to weeks, and patientsrarely can have an initial presentation of FUMHD.² The duration of illness has been reported to be 1 to 24 months⁵; however, the length of illness still remains unclear, as many studies of FUMHD are case reports with limited follow-up. Our patient had a disease duration of at least 27 months. The lesions of FUMHD usually are generalized with flexural prominence, and mucosal involvement occurs in approximately one-quarter of cases. Hypertrophic scarring may be seen after the ulcerated lesions heal.² The incidence of FUMHD is higher in men than in women, and it is more common in younger individuals.^2,6 There have been reported fatalities associated with FUMHD, mostly in adults.^2,4

The clinical differential diagnosis for PLEVA includes disseminated herpes zoster, varicella-zoster virus or coxsackievirus infections, lymphomatoid papulosis, angiodestructive lymphoma such as extranodal natural killer/T-cell lymphoma, drug eruption, arthropod bite, erythema multiforme, ecthyma, ecthyma gangrenosum, necrotic folliculitis, and cutaneous small vessel vasculitis. To differentiate between these diagnoses and PLEVA or FUMHD, it is important to take a strong clinical history. For example, for varicella-zoster virus and coxsackievirus infections, exposure history to the viruses and vaccination history for varicella-zoster virus can help elucidate the diagnosis.

Skin biopsy can help differentiate between these entities and PLEVA or FUMHD. The histopathology of a nonulcerated lesion of FUMHD shows parakeratosis, spongiosis, and lymphocyte exocytosis, as well as lymphocytic vasculitis—findings commonly seen in PLEVA. With the ulceronecrotic lesions of FUMHD, epidermal necrosis and ulceration can be seen microscopically.² Although skin biopsy is not absolutely necessary for making the diagnosis of PLEVA, it can be helpful.³ However, given the dramatic and extreme clinical impression with an extensive differential diagnosis that includes disorders ranging from infectious to neoplastic, biopsy of FUMHD with clinicopathologic correlation often is required.

It is important to avoid biopsying ulcerated lesions of FUMHD, as the histopathologic findings are more likely to be nonspecific. Additionally, nonspecific features often are seen with immunohistochemistry; abnormal laboratory testing may be seen in FUMHD, but there is no specific test to diagnose FUMHD.² Finally, a predominantly CD8⁺ cell infiltrate was seen in 4 of 6 cases of FUMHD, with 2 cases showing a mixed infiltrate of CD8⁺ and CD4⁺ cells.^5,7-10

Although no unified diagnostic criterion exists for FUMHD, Nofal et al² proposed criteria comprised of constant features, which are found in every case of FUMHD and can confirm the diagnosis alone, and variable features to help ensure that cases of FUMHD are not missed. The constant features include fever, acute onset of generalized ulceronecrotic papules and plaques, a course that is rapid and progressive (without a tendency for spontaneous resolution), and histopathology that is consistent with PLEVA. The variable features include history of PLEVA, involvement of mucous membranes, and systemic involvement.²

No single unifying treatment modality for all cases of FUMHD has been described. Immunosuppressive drugs (eg, systemic steroids, methotrexate), antibiotics, antivirals, phototherapy, intravenous immunoglobulin, and dapsone have been tried in patients with FUMHD.² Combination therapy with an oral medication such as erythromycin or methotrexate and psoralen plus UVA may be effective for FUMHD.³ Additionally, some authors believe that patients with FUMHD should be treated similar to burn victims with intensive supportive care.²

The etiology of PLEVA is unknown, but it is presumed to be associated with an effector cytotoxic T-cell response to either an infectious agent or a drug.¹¹Three studies have shown that most PLEVA cases (100% [3/3]; 65% [13/20]; and 57% [8/14]) demonstrate T-cell clonality,^12-14 and some have suggested that PLEVA may be a T-cell lymphoproliferative disorder.^12,13 Additionally, in a case report of 2 children with PLEVA who progressed to cutaneous T-cell lymphoma, the authors suggested that PLEVA may be related to nonaggressive cutaneous T-cell lymphoma.¹⁵ Of note, T-cell clonality, often found through the analysis of T-cell receptor gene rearrangement, is not an absolute criterion for determining malignancy, as some benign conditions may have clonality.¹⁶ However, in another study, clonality was found in only 1 of 10 cases of PLEVA, suggesting that PLEVA stems from an inflammatory reaction to infectious or other triggering agents.¹⁷

Four cases of FUMHD with monoclonality have been reported,^4,7,8 and some researchers propose that FUMHD may be a subset of cutaneous T-cell lymphoma.⁷ However, 2 other cases of FUMHD did not show monoclonality of T cells,^5,18 suggesting that FUMHD may represent an inflammatory disorder, rather than a lymphoproliferative process of T cells.¹⁸ Given the controversy surrounding the clonality of FUMHD, T-cell gene rearrangement studies were not performed in our case.

A prominent Florida oncologist was arrested in December, and some members of the medical community are puzzled.

Michael Dattoli, MD, a radiation oncologist and physician-in-chief of the Dattoli Cancer Center in Sarasota, Fla., has been charged with prescription and insurance fraud, according to the Sarasota County Sheriff’s Office.

The charges include three counts of possessing a controlled substance by fraud, three counts of criminal use of personal identification information, and three counts of insurance fraud.

Dr. Dattoli was arrested on December 16.

According to investigators, a former employee of the Dattoli Cancer Center alleged that Dr. Dattoli filled prescriptions for diazepam (Valium) three times in his wife’s name using a different healthcare provider’s information.

Some experts find it bizarre for a physician of his stature to have possibly engaged in such a transgression — a relatively minor fraud that comes with serious consequences.

“This is a very well-respected physician who has done a lot of good in the community, and this makes no sense at all,” said Jay Wolfson, PhD, JD, Distinguished Service Professor of Public Health Medicine and Pharmacy and associate vice president for health law, policy, and safety at the University of South Florida, Tampa. “It’s low-level fraud, and not like he was laundering money or involved in pill mills, which has been problematic in Florida.”

According to recent accounts from local news agencies, in August 2021, the Sarasota police connected with investigators from the Sarasota County Sheriff’s Office’s Pharmaceutical Diversion Unit regarding prescription fraud dating back to 2019 and 2020 involving Dr. Dattoli and a “victim.”

The victim, a former employee of the Dattoli Cancer Center, had left his job at the end of 2020 after 5 years. His name and position at the cancer center were redacted in the arrest warrant, but the warrant mentions that he treated patients while he worked at the center.

The former employee told police that when checking the Florida prescription drug database for controlled substances in September 2021, he noticed that several fraudulent prescriptions for diazepam — a controlled substance — had been entered from 2020. The recipient was Dr. Dattoli’s wife, Rita Beatrice Dattoli, but the former employee stated he had never authorized these prescriptions and that Dr. Dattoli’s wife was never his patient.

In September 2021, the police obtained copies of multiple prescriptions from local pharmacies that were phoned in throughout 2020 by the Dattoli Cancer Center. The prescriptions were filled and picked up the same day by Dr. Dattoli himself, whose identity had been verified by his driver’s license.

Dr. Dattoli’s wife, who was interviewed by the police in October 2021, stated she had never been a patient at the center, that the prescription was not hers, and that she had never used the prescribed drug.

A month later, the Sarasota police subpoenaed bank records that matched accounts belonging to Dr. Dattoli, which showed the same dates, total purchase price, and stores where fraudulent prescriptions were filled, picked up, and purchased.

None of this really makes any sense, Dr. Wolfson told this news organizataion. “Any physician in need of Valium doesn’t have to forge a prescription, he can get it from any of his colleagues,” he noted. “And why put it in his wife’s name? He also submitted it to his insurance, which leaves more of a paper trail. And he didn’t need to have insurance pay for it — Valium is a very inexpensive drug.”

Plus, Dr. Wolfson added, “I know people who have been treated by Dr. Dattoli and they have nothing but good things to say about him — he’s an excellent doctor with a great bedside manner. His record is clean, he’s never been reprimanded, he’s built a successful practice, and then this thing just parachutes out of the sky.”

The investigation is ongoing, and detectives from the Sarasota police department have stated that they “believe there may be additional victims.”

Dr. Dattoli was released the day after his arrest on a $1,500 bond. His arraignment is scheduled for January 22. If convicted, he could face prison time, fines, or even lose his license to practice medicine.

Dr. Wolfson added that the arraignment is the first step in the process. “But even if it can be determined that he forged a signature, I don’t think it will rise to a level where his license will be revoked,” he said.

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

A prominent Florida oncologist was arrested in December, and some members of the medical community are puzzled.

Michael Dattoli, MD, a radiation oncologist and physician-in-chief of the Dattoli Cancer Center in Sarasota, Fla., has been charged with prescription and insurance fraud, according to the Sarasota County Sheriff’s Office.

The charges include three counts of possessing a controlled substance by fraud, three counts of criminal use of personal identification information, and three counts of insurance fraud.

Dr. Dattoli was arrested on December 16.

According to investigators, a former employee of the Dattoli Cancer Center alleged that Dr. Dattoli filled prescriptions for diazepam (Valium) three times in his wife’s name using a different healthcare provider’s information.

Some experts find it bizarre for a physician of his stature to have possibly engaged in such a transgression — a relatively minor fraud that comes with serious consequences.

“This is a very well-respected physician who has done a lot of good in the community, and this makes no sense at all,” said Jay Wolfson, PhD, JD, Distinguished Service Professor of Public Health Medicine and Pharmacy and associate vice president for health law, policy, and safety at the University of South Florida, Tampa. “It’s low-level fraud, and not like he was laundering money or involved in pill mills, which has been problematic in Florida.”

According to recent accounts from local news agencies, in August 2021, the Sarasota police connected with investigators from the Sarasota County Sheriff’s Office’s Pharmaceutical Diversion Unit regarding prescription fraud dating back to 2019 and 2020 involving Dr. Dattoli and a “victim.”

The victim, a former employee of the Dattoli Cancer Center, had left his job at the end of 2020 after 5 years. His name and position at the cancer center were redacted in the arrest warrant, but the warrant mentions that he treated patients while he worked at the center.

The former employee told police that when checking the Florida prescription drug database for controlled substances in September 2021, he noticed that several fraudulent prescriptions for diazepam — a controlled substance — had been entered from 2020. The recipient was Dr. Dattoli’s wife, Rita Beatrice Dattoli, but the former employee stated he had never authorized these prescriptions and that Dr. Dattoli’s wife was never his patient.

In September 2021, the police obtained copies of multiple prescriptions from local pharmacies that were phoned in throughout 2020 by the Dattoli Cancer Center. The prescriptions were filled and picked up the same day by Dr. Dattoli himself, whose identity had been verified by his driver’s license.

Dr. Dattoli’s wife, who was interviewed by the police in October 2021, stated she had never been a patient at the center, that the prescription was not hers, and that she had never used the prescribed drug.

A month later, the Sarasota police subpoenaed bank records that matched accounts belonging to Dr. Dattoli, which showed the same dates, total purchase price, and stores where fraudulent prescriptions were filled, picked up, and purchased.

None of this really makes any sense, Dr. Wolfson told this news organizataion. “Any physician in need of Valium doesn’t have to forge a prescription, he can get it from any of his colleagues,” he noted. “And why put it in his wife’s name? He also submitted it to his insurance, which leaves more of a paper trail. And he didn’t need to have insurance pay for it — Valium is a very inexpensive drug.”

Plus, Dr. Wolfson added, “I know people who have been treated by Dr. Dattoli and they have nothing but good things to say about him — he’s an excellent doctor with a great bedside manner. His record is clean, he’s never been reprimanded, he’s built a successful practice, and then this thing just parachutes out of the sky.”

The investigation is ongoing, and detectives from the Sarasota police department have stated that they “believe there may be additional victims.”

Dr. Dattoli was released the day after his arrest on a $1,500 bond. His arraignment is scheduled for January 22. If convicted, he could face prison time, fines, or even lose his license to practice medicine.

Dr. Wolfson added that the arraignment is the first step in the process. “But even if it can be determined that he forged a signature, I don’t think it will rise to a level where his license will be revoked,” he said.

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

A prominent Florida oncologist was arrested in December, and some members of the medical community are puzzled.

Michael Dattoli, MD, a radiation oncologist and physician-in-chief of the Dattoli Cancer Center in Sarasota, Fla., has been charged with prescription and insurance fraud, according to the Sarasota County Sheriff’s Office.

The charges include three counts of possessing a controlled substance by fraud, three counts of criminal use of personal identification information, and three counts of insurance fraud.

Dr. Dattoli was arrested on December 16.

According to investigators, a former employee of the Dattoli Cancer Center alleged that Dr. Dattoli filled prescriptions for diazepam (Valium) three times in his wife’s name using a different healthcare provider’s information.

Some experts find it bizarre for a physician of his stature to have possibly engaged in such a transgression — a relatively minor fraud that comes with serious consequences.

“This is a very well-respected physician who has done a lot of good in the community, and this makes no sense at all,” said Jay Wolfson, PhD, JD, Distinguished Service Professor of Public Health Medicine and Pharmacy and associate vice president for health law, policy, and safety at the University of South Florida, Tampa. “It’s low-level fraud, and not like he was laundering money or involved in pill mills, which has been problematic in Florida.”

According to recent accounts from local news agencies, in August 2021, the Sarasota police connected with investigators from the Sarasota County Sheriff’s Office’s Pharmaceutical Diversion Unit regarding prescription fraud dating back to 2019 and 2020 involving Dr. Dattoli and a “victim.”

The victim, a former employee of the Dattoli Cancer Center, had left his job at the end of 2020 after 5 years. His name and position at the cancer center were redacted in the arrest warrant, but the warrant mentions that he treated patients while he worked at the center.

The former employee told police that when checking the Florida prescription drug database for controlled substances in September 2021, he noticed that several fraudulent prescriptions for diazepam — a controlled substance — had been entered from 2020. The recipient was Dr. Dattoli’s wife, Rita Beatrice Dattoli, but the former employee stated he had never authorized these prescriptions and that Dr. Dattoli’s wife was never his patient.

In September 2021, the police obtained copies of multiple prescriptions from local pharmacies that were phoned in throughout 2020 by the Dattoli Cancer Center. The prescriptions were filled and picked up the same day by Dr. Dattoli himself, whose identity had been verified by his driver’s license.

Dr. Dattoli’s wife, who was interviewed by the police in October 2021, stated she had never been a patient at the center, that the prescription was not hers, and that she had never used the prescribed drug.

A month later, the Sarasota police subpoenaed bank records that matched accounts belonging to Dr. Dattoli, which showed the same dates, total purchase price, and stores where fraudulent prescriptions were filled, picked up, and purchased.

None of this really makes any sense, Dr. Wolfson told this news organizataion. “Any physician in need of Valium doesn’t have to forge a prescription, he can get it from any of his colleagues,” he noted. “And why put it in his wife’s name? He also submitted it to his insurance, which leaves more of a paper trail. And he didn’t need to have insurance pay for it — Valium is a very inexpensive drug.”

Plus, Dr. Wolfson added, “I know people who have been treated by Dr. Dattoli and they have nothing but good things to say about him — he’s an excellent doctor with a great bedside manner. His record is clean, he’s never been reprimanded, he’s built a successful practice, and then this thing just parachutes out of the sky.”

The investigation is ongoing, and detectives from the Sarasota police department have stated that they “believe there may be additional victims.”

Dr. Dattoli was released the day after his arrest on a $1,500 bond. His arraignment is scheduled for January 22. If convicted, he could face prison time, fines, or even lose his license to practice medicine.

Dr. Wolfson added that the arraignment is the first step in the process. “But even if it can be determined that he forged a signature, I don’t think it will rise to a level where his license will be revoked,” he said.

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

Patients with chronic obstructive pulmonary disease (COPD) who are both frail and who have poor lung function or dyspnea are at especially high risk of disability within 3 to 5 years as well as all-cause mortality years later, a prospective cohort study of community-dwelling adults has shown.

“Frailty, a widely recognized geriatric syndrome characterized by multidimensional functional decline in bio-psycho-social factors, is associated with functional disability and mortality,” senior author Tze Pin Ng, MD, National University of Singapore, and colleagues explain.“Our results ... suggest that beyond traditional prognostic markers such as FEV1% (forced expiratory volume in 1 second) and dyspnea, the physical frailty phenotype provides additional useful prognostic information on future risks of disability and mortality,” the authors suggest.

The study was published online Dec. 12 in the journal CHEST^®.

SLAS-1 and SLAS-2

Data from the Singapore Longitudinal Ageing Study (SLAS-1) and SLAS-2 were collected and analyzed. SLAS-1 recruited 2,804 participants 55 years of age and older from Sept. 2003 through Dec. 2004, while SLAS-2 recruited 3,270 participants of the same age between March 2009 and June 2013. “Follow-up visits and assessments were conducted approximately 3-5 years apart,” the investigators noted.

Mortality was determined at a mean of 9.5 years of follow-up for SLAS-1 participants and a mean of 6.5 years’ follow-up for SLAS-2 participants. A total of 4,627 participants were eventually included in the analysis, of whom 1,162 patients had COPD and 3,465 patients did not. COPD was classified as mild if FEV1% was greater than or equal to 80%; moderate if FEV1% was greater than or equal to 50% to less than 80%, and severe if FEV1% was less than 50%.

Frailty in turn was based on five clinical criteria, including weakness, slowness, low physical activity, exhaustion, and shrinking. Participants were classified as frail if they met three or more of these criteria and prefrail if they met one or two criteria.

Adverse health outcomes were judged on the basis of instrumental or basic activities of daily living (IADL/ADL), while disability was judged by self-reported difficulties in or requiring assistance with at least one IADL or ADL.
 

Frail or prefrail

Almost half of the participants were frail or prefrail, as the authors reported, while 25% had COPD. Among the participants with COPD, 30% had moderate to severe COPD, 6.4% had dyspnea, and almost half had prefrailty, while approximately 7% were classified as frail.

This percentage was 86% higher than it was for participants without COPD, among whom just 3.2% were assessed as frail, at an odds ratio of 1.86 (95% CI, 1.35-2.56). Further adjustments for possible confounders reduced the gap between frail COPD and frail non-COPD participants, but frailty remained significantly associated with COPD, at an OR of 1.61 (95% CI, 1.15-2.26), the investigators note.

Furthermore, compared to those without COPD, a diagnosis of COPD without and with dyspnea was associated with a 1.5- and 4.2-fold increase in prevalent frailty (95% CI, 1.04-2.08; 1.84-9.19), respectively, although not with prefrailty. Again, adjusting for multiple confounders, FEV1%, dyspnea, and both prefrailty and frailty were associated with an approximately twofold higher prevalence of IADL/ADL disability, while the prevalence of IADL/ADL disability for participants with COPD was approximately fourfold higher in those with co-occurring FEV1% less than 80% with either prefrailty, frailty, or dyspnea.

Furthermore, the presence of prefrailty or frailty in combination with a lower FEV1% or dyspnea was associated with a 3.7- to 3.8-fold increased risk of having an IADL or ADL disability.
 

Frailty and mortality

Some 1,116 participants with COPD were followed for a mean of 2,981 days for mortality outcomes. Both FEV1% less than 50% and the presence of prefrailty and frailty almost doubled the risk of mortality, at an adjusted hazard ratio of 1.8 (95% CI, 1.24-2.68) compared to patients with an FEV1% greater than or equal to 80%. In combination with either FEV1% less than 80% or prefrailty/frailty, dyspnea almost more than doubled the risk of mortality, at an HR of 2.4 for both combinations.

“However, the mortality risk of participants with COPD was highest among those with FEV1% less than 80% and prefrailty/frailty,” the authors note, more than tripling mortality risk at an adjusted HR of 3.25 (95% CI, 1.97-5.36). Interestingly, FEV1 less than 80% and prefrailty/frailty – both alone and in combination – were also associated with a twofold to fourfold increased risk of IADL or ADL disability in participants without COPD but were less strongly associated with mortality.

Researchers then went on to create a summary risk score containing all relevant variables with values ranging from 0 to 5. The highest risk category of 3 to 5 was associated with a 7- to 8.5-fold increased risk for IADL and ADL disability and mortality among participants with COPD, and that risk remained high after adjusting for multiple confounders.

Interestingly, frailty did not significantly predict mortality in women, while dyspnea did not significantly predict mortality in men. “Recognition and assessment of physical frailty in addition to FEV1% and dyspnea would allow for more accurate identification and targeted treatment of COPD at risk of future adverse outcomes,” the authors suggest.
 

Frailty scoring system

Asked to comment on the study, Sachin Gupta, MD, a pulmonologist and critical care specialist at Alameda Health System in Oakland, Calif., noted that the current study adds to the body of literature that outcomes in patients with COPD depend as much on objectively measured variables as on qualitative measures. “By applying a frailty scoring system, these researchers were able to categorize frailty and study its impact on patient characteristics and outcomes,” he told this news organization in an email.

The summary risk assessment tool developed and assessed is familiar: It carries parallels to the widely utilized BODE Index, replacing body mass index and 6-minute walk distance with the frailty scale, he added. “Findings from this study support the idea that what meets the eye in face-to-face visits – frailty – can be codified and be part of a tool that is predictive of outcomes,” Dr. Gupta underscored.

The authors had no conflicts of interest to declare. Dr. Gupta disclosed that he is also an employee and shareholder at Genentech.

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

Patients with chronic obstructive pulmonary disease (COPD) who are both frail and who have poor lung function or dyspnea are at especially high risk of disability within 3 to 5 years as well as all-cause mortality years later, a prospective cohort study of community-dwelling adults has shown.

“Frailty, a widely recognized geriatric syndrome characterized by multidimensional functional decline in bio-psycho-social factors, is associated with functional disability and mortality,” senior author Tze Pin Ng, MD, National University of Singapore, and colleagues explain.“Our results ... suggest that beyond traditional prognostic markers such as FEV1% (forced expiratory volume in 1 second) and dyspnea, the physical frailty phenotype provides additional useful prognostic information on future risks of disability and mortality,” the authors suggest.

The study was published online Dec. 12 in the journal CHEST^®.

SLAS-1 and SLAS-2

Data from the Singapore Longitudinal Ageing Study (SLAS-1) and SLAS-2 were collected and analyzed. SLAS-1 recruited 2,804 participants 55 years of age and older from Sept. 2003 through Dec. 2004, while SLAS-2 recruited 3,270 participants of the same age between March 2009 and June 2013. “Follow-up visits and assessments were conducted approximately 3-5 years apart,” the investigators noted.

Mortality was determined at a mean of 9.5 years of follow-up for SLAS-1 participants and a mean of 6.5 years’ follow-up for SLAS-2 participants. A total of 4,627 participants were eventually included in the analysis, of whom 1,162 patients had COPD and 3,465 patients did not. COPD was classified as mild if FEV1% was greater than or equal to 80%; moderate if FEV1% was greater than or equal to 50% to less than 80%, and severe if FEV1% was less than 50%.

Frailty in turn was based on five clinical criteria, including weakness, slowness, low physical activity, exhaustion, and shrinking. Participants were classified as frail if they met three or more of these criteria and prefrail if they met one or two criteria.

Adverse health outcomes were judged on the basis of instrumental or basic activities of daily living (IADL/ADL), while disability was judged by self-reported difficulties in or requiring assistance with at least one IADL or ADL.
 

Frail or prefrail

Almost half of the participants were frail or prefrail, as the authors reported, while 25% had COPD. Among the participants with COPD, 30% had moderate to severe COPD, 6.4% had dyspnea, and almost half had prefrailty, while approximately 7% were classified as frail.

This percentage was 86% higher than it was for participants without COPD, among whom just 3.2% were assessed as frail, at an odds ratio of 1.86 (95% CI, 1.35-2.56). Further adjustments for possible confounders reduced the gap between frail COPD and frail non-COPD participants, but frailty remained significantly associated with COPD, at an OR of 1.61 (95% CI, 1.15-2.26), the investigators note.

Furthermore, compared to those without COPD, a diagnosis of COPD without and with dyspnea was associated with a 1.5- and 4.2-fold increase in prevalent frailty (95% CI, 1.04-2.08; 1.84-9.19), respectively, although not with prefrailty. Again, adjusting for multiple confounders, FEV1%, dyspnea, and both prefrailty and frailty were associated with an approximately twofold higher prevalence of IADL/ADL disability, while the prevalence of IADL/ADL disability for participants with COPD was approximately fourfold higher in those with co-occurring FEV1% less than 80% with either prefrailty, frailty, or dyspnea.

Furthermore, the presence of prefrailty or frailty in combination with a lower FEV1% or dyspnea was associated with a 3.7- to 3.8-fold increased risk of having an IADL or ADL disability.
 

Frailty and mortality

Some 1,116 participants with COPD were followed for a mean of 2,981 days for mortality outcomes. Both FEV1% less than 50% and the presence of prefrailty and frailty almost doubled the risk of mortality, at an adjusted hazard ratio of 1.8 (95% CI, 1.24-2.68) compared to patients with an FEV1% greater than or equal to 80%. In combination with either FEV1% less than 80% or prefrailty/frailty, dyspnea almost more than doubled the risk of mortality, at an HR of 2.4 for both combinations.

“However, the mortality risk of participants with COPD was highest among those with FEV1% less than 80% and prefrailty/frailty,” the authors note, more than tripling mortality risk at an adjusted HR of 3.25 (95% CI, 1.97-5.36). Interestingly, FEV1 less than 80% and prefrailty/frailty – both alone and in combination – were also associated with a twofold to fourfold increased risk of IADL or ADL disability in participants without COPD but were less strongly associated with mortality.

Researchers then went on to create a summary risk score containing all relevant variables with values ranging from 0 to 5. The highest risk category of 3 to 5 was associated with a 7- to 8.5-fold increased risk for IADL and ADL disability and mortality among participants with COPD, and that risk remained high after adjusting for multiple confounders.

Interestingly, frailty did not significantly predict mortality in women, while dyspnea did not significantly predict mortality in men. “Recognition and assessment of physical frailty in addition to FEV1% and dyspnea would allow for more accurate identification and targeted treatment of COPD at risk of future adverse outcomes,” the authors suggest.
 

Frailty scoring system

Asked to comment on the study, Sachin Gupta, MD, a pulmonologist and critical care specialist at Alameda Health System in Oakland, Calif., noted that the current study adds to the body of literature that outcomes in patients with COPD depend as much on objectively measured variables as on qualitative measures. “By applying a frailty scoring system, these researchers were able to categorize frailty and study its impact on patient characteristics and outcomes,” he told this news organization in an email.

The summary risk assessment tool developed and assessed is familiar: It carries parallels to the widely utilized BODE Index, replacing body mass index and 6-minute walk distance with the frailty scale, he added. “Findings from this study support the idea that what meets the eye in face-to-face visits – frailty – can be codified and be part of a tool that is predictive of outcomes,” Dr. Gupta underscored.

The authors had no conflicts of interest to declare. Dr. Gupta disclosed that he is also an employee and shareholder at Genentech.

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

Patients with chronic obstructive pulmonary disease (COPD) who are both frail and who have poor lung function or dyspnea are at especially high risk of disability within 3 to 5 years as well as all-cause mortality years later, a prospective cohort study of community-dwelling adults has shown.

“Frailty, a widely recognized geriatric syndrome characterized by multidimensional functional decline in bio-psycho-social factors, is associated with functional disability and mortality,” senior author Tze Pin Ng, MD, National University of Singapore, and colleagues explain.“Our results ... suggest that beyond traditional prognostic markers such as FEV1% (forced expiratory volume in 1 second) and dyspnea, the physical frailty phenotype provides additional useful prognostic information on future risks of disability and mortality,” the authors suggest.

The study was published online Dec. 12 in the journal CHEST^®.

SLAS-1 and SLAS-2

Data from the Singapore Longitudinal Ageing Study (SLAS-1) and SLAS-2 were collected and analyzed. SLAS-1 recruited 2,804 participants 55 years of age and older from Sept. 2003 through Dec. 2004, while SLAS-2 recruited 3,270 participants of the same age between March 2009 and June 2013. “Follow-up visits and assessments were conducted approximately 3-5 years apart,” the investigators noted.

Mortality was determined at a mean of 9.5 years of follow-up for SLAS-1 participants and a mean of 6.5 years’ follow-up for SLAS-2 participants. A total of 4,627 participants were eventually included in the analysis, of whom 1,162 patients had COPD and 3,465 patients did not. COPD was classified as mild if FEV1% was greater than or equal to 80%; moderate if FEV1% was greater than or equal to 50% to less than 80%, and severe if FEV1% was less than 50%.

Frailty in turn was based on five clinical criteria, including weakness, slowness, low physical activity, exhaustion, and shrinking. Participants were classified as frail if they met three or more of these criteria and prefrail if they met one or two criteria.

Adverse health outcomes were judged on the basis of instrumental or basic activities of daily living (IADL/ADL), while disability was judged by self-reported difficulties in or requiring assistance with at least one IADL or ADL.
 

Frail or prefrail

Almost half of the participants were frail or prefrail, as the authors reported, while 25% had COPD. Among the participants with COPD, 30% had moderate to severe COPD, 6.4% had dyspnea, and almost half had prefrailty, while approximately 7% were classified as frail.

This percentage was 86% higher than it was for participants without COPD, among whom just 3.2% were assessed as frail, at an odds ratio of 1.86 (95% CI, 1.35-2.56). Further adjustments for possible confounders reduced the gap between frail COPD and frail non-COPD participants, but frailty remained significantly associated with COPD, at an OR of 1.61 (95% CI, 1.15-2.26), the investigators note.

Furthermore, compared to those without COPD, a diagnosis of COPD without and with dyspnea was associated with a 1.5- and 4.2-fold increase in prevalent frailty (95% CI, 1.04-2.08; 1.84-9.19), respectively, although not with prefrailty. Again, adjusting for multiple confounders, FEV1%, dyspnea, and both prefrailty and frailty were associated with an approximately twofold higher prevalence of IADL/ADL disability, while the prevalence of IADL/ADL disability for participants with COPD was approximately fourfold higher in those with co-occurring FEV1% less than 80% with either prefrailty, frailty, or dyspnea.

Furthermore, the presence of prefrailty or frailty in combination with a lower FEV1% or dyspnea was associated with a 3.7- to 3.8-fold increased risk of having an IADL or ADL disability.
 

Frailty and mortality

Some 1,116 participants with COPD were followed for a mean of 2,981 days for mortality outcomes. Both FEV1% less than 50% and the presence of prefrailty and frailty almost doubled the risk of mortality, at an adjusted hazard ratio of 1.8 (95% CI, 1.24-2.68) compared to patients with an FEV1% greater than or equal to 80%. In combination with either FEV1% less than 80% or prefrailty/frailty, dyspnea almost more than doubled the risk of mortality, at an HR of 2.4 for both combinations.

“However, the mortality risk of participants with COPD was highest among those with FEV1% less than 80% and prefrailty/frailty,” the authors note, more than tripling mortality risk at an adjusted HR of 3.25 (95% CI, 1.97-5.36). Interestingly, FEV1 less than 80% and prefrailty/frailty – both alone and in combination – were also associated with a twofold to fourfold increased risk of IADL or ADL disability in participants without COPD but were less strongly associated with mortality.

Researchers then went on to create a summary risk score containing all relevant variables with values ranging from 0 to 5. The highest risk category of 3 to 5 was associated with a 7- to 8.5-fold increased risk for IADL and ADL disability and mortality among participants with COPD, and that risk remained high after adjusting for multiple confounders.

Interestingly, frailty did not significantly predict mortality in women, while dyspnea did not significantly predict mortality in men. “Recognition and assessment of physical frailty in addition to FEV1% and dyspnea would allow for more accurate identification and targeted treatment of COPD at risk of future adverse outcomes,” the authors suggest.
 

Frailty scoring system

Asked to comment on the study, Sachin Gupta, MD, a pulmonologist and critical care specialist at Alameda Health System in Oakland, Calif., noted that the current study adds to the body of literature that outcomes in patients with COPD depend as much on objectively measured variables as on qualitative measures. “By applying a frailty scoring system, these researchers were able to categorize frailty and study its impact on patient characteristics and outcomes,” he told this news organization in an email.

The summary risk assessment tool developed and assessed is familiar: It carries parallels to the widely utilized BODE Index, replacing body mass index and 6-minute walk distance with the frailty scale, he added. “Findings from this study support the idea that what meets the eye in face-to-face visits – frailty – can be codified and be part of a tool that is predictive of outcomes,” Dr. Gupta underscored.

The authors had no conflicts of interest to declare. Dr. Gupta disclosed that he is also an employee and shareholder at Genentech.

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

People who have had prior SARS-CoV-2 infection report significantly more symptoms of cognitive dysfunction and specifically executive dysfunction than people in the general population with no such infection, according to new data published on the preprint server medRxiv.

Researchers, led by Peter A. Hall, PhD, with the University of Waterloo (Ont.), found that COVID infection is associated with executive dysfunction among young and middle-aged adults, including for those not exposed to intubation or hospitalization.

The findings have not been peer reviewed.

The study included a representative cohort of 1,958 community-dwelling young and middle-aged adults. It used a balanced proportion of infected and uninfected people to estimate the link between SARS-CoV-2 infection and cognitive/executive dysfunction.

The authors noted that the survey was conducted from Sept. 28 to Oct. 21, 2021, when the primary variant in Canada was Delta.

The research was a cross-sectional observational study with data from the ongoing Canadian COVID-19 Experiences Survey. It included equal representation of vaccinated and vaccine-hesitant adults aged 18-54 years. COVID-19 symptoms ranged from negligible to life-threatening cases requiring hospitalization.

Half in the cohort (50.2%) received two vaccine shots; 43.3% had received no shots; and 5.5% received one shot, but were not intending to receive a second shot.
 

Dose-response relationship

According to the paper, those with prior COVID-19 infection, regardless of symptom severity, reported a significantly higher number of symptoms of executive dysfunction than their noninfected counterparts (mechanical adjustment, 1.63, standard error, 0.08; 95% confidence interval, 1.47-1.80; P = .001).

The researchers also found a dose-response relationship between COVID-19 symptom severity and cognitive dysfunction. Those with moderate and very/extremely severe COVID-19 symptoms were linked with significantly greater dysfunction.

“This reinforces what we’re hearing about – that COVID is not ‘one and done.’ It can have lasting and quite subtle and damaging effects on the human body,” William Schaffner, MD, infectious disease specialist with Vanderbilt University, Nashville, Tenn., said in an interview.

Measuring executive functioning – including the ability to make sound decisions – is something other studies haven’t typically addressed, he said.

Men were likely to report more cognitive dysfunction symptoms than women (beta, 0.15; P < .001). Younger adults (25-39 years) were more likely to experience cognitive dysfunction than those age 40-54 (beta, 0.30; P < .001).

Dr. Schaffner said it was troubling that young people are more likely to experience the dysfunction.

“When we think of ‘brain fog’ we think of older persons who are already predisposed to have more memory lapses as they get older,” he said.

The link between cognitive dysfunction and COVID-19 infection has been shown in other studies, but many have not used representative samples and have not compared results with noninfected controls in the general population, the authors wrote.

Executive dysfunction was measured using four questions from the Deficits in Executive Functioning Scale. Respondents were asked how often they have experienced these scenarios in the past 6 months:
 

• “I am unable to inhibit my reactions or responses to events or to other people.”
• “I make impulsive comments to others.”
• “I am likely to do things without considering the consequences for doing them.”
• “I act without thinking.”

“This makes it even more important that we talk about vaccination,” Dr. Schaffner said, “because clearly the more seriously ill you are, the more likely this sort of thing is likely to happen and vaccines have been shown time and again to avert hospitalizations and more serious illness. It also makes more important the monoclonal antibody treatments we have and the antivirals, which will prevent the evolution of mild disease into something more serious.”

This research was supported by a grant from the Canadian Institutes for Health Research, Institute for Population and Public Health. The study authors and Dr. Schaffner disclosed no relevant financial relationships.

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

People who have had prior SARS-CoV-2 infection report significantly more symptoms of cognitive dysfunction and specifically executive dysfunction than people in the general population with no such infection, according to new data published on the preprint server medRxiv.

Researchers, led by Peter A. Hall, PhD, with the University of Waterloo (Ont.), found that COVID infection is associated with executive dysfunction among young and middle-aged adults, including for those not exposed to intubation or hospitalization.

The findings have not been peer reviewed.

The study included a representative cohort of 1,958 community-dwelling young and middle-aged adults. It used a balanced proportion of infected and uninfected people to estimate the link between SARS-CoV-2 infection and cognitive/executive dysfunction.

The authors noted that the survey was conducted from Sept. 28 to Oct. 21, 2021, when the primary variant in Canada was Delta.

The research was a cross-sectional observational study with data from the ongoing Canadian COVID-19 Experiences Survey. It included equal representation of vaccinated and vaccine-hesitant adults aged 18-54 years. COVID-19 symptoms ranged from negligible to life-threatening cases requiring hospitalization.

Half in the cohort (50.2%) received two vaccine shots; 43.3% had received no shots; and 5.5% received one shot, but were not intending to receive a second shot.
 

Dose-response relationship

According to the paper, those with prior COVID-19 infection, regardless of symptom severity, reported a significantly higher number of symptoms of executive dysfunction than their noninfected counterparts (mechanical adjustment, 1.63, standard error, 0.08; 95% confidence interval, 1.47-1.80; P = .001).

The researchers also found a dose-response relationship between COVID-19 symptom severity and cognitive dysfunction. Those with moderate and very/extremely severe COVID-19 symptoms were linked with significantly greater dysfunction.

“This reinforces what we’re hearing about – that COVID is not ‘one and done.’ It can have lasting and quite subtle and damaging effects on the human body,” William Schaffner, MD, infectious disease specialist with Vanderbilt University, Nashville, Tenn., said in an interview.

Measuring executive functioning – including the ability to make sound decisions – is something other studies haven’t typically addressed, he said.

Men were likely to report more cognitive dysfunction symptoms than women (beta, 0.15; P < .001). Younger adults (25-39 years) were more likely to experience cognitive dysfunction than those age 40-54 (beta, 0.30; P < .001).

Dr. Schaffner said it was troubling that young people are more likely to experience the dysfunction.

“When we think of ‘brain fog’ we think of older persons who are already predisposed to have more memory lapses as they get older,” he said.

The link between cognitive dysfunction and COVID-19 infection has been shown in other studies, but many have not used representative samples and have not compared results with noninfected controls in the general population, the authors wrote.

Executive dysfunction was measured using four questions from the Deficits in Executive Functioning Scale. Respondents were asked how often they have experienced these scenarios in the past 6 months:
 

• “I am unable to inhibit my reactions or responses to events or to other people.”
• “I make impulsive comments to others.”
• “I am likely to do things without considering the consequences for doing them.”
• “I act without thinking.”

“This makes it even more important that we talk about vaccination,” Dr. Schaffner said, “because clearly the more seriously ill you are, the more likely this sort of thing is likely to happen and vaccines have been shown time and again to avert hospitalizations and more serious illness. It also makes more important the monoclonal antibody treatments we have and the antivirals, which will prevent the evolution of mild disease into something more serious.”

This research was supported by a grant from the Canadian Institutes for Health Research, Institute for Population and Public Health. The study authors and Dr. Schaffner disclosed no relevant financial relationships.

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

People who have had prior SARS-CoV-2 infection report significantly more symptoms of cognitive dysfunction and specifically executive dysfunction than people in the general population with no such infection, according to new data published on the preprint server medRxiv.

Researchers, led by Peter A. Hall, PhD, with the University of Waterloo (Ont.), found that COVID infection is associated with executive dysfunction among young and middle-aged adults, including for those not exposed to intubation or hospitalization.

The findings have not been peer reviewed.

The study included a representative cohort of 1,958 community-dwelling young and middle-aged adults. It used a balanced proportion of infected and uninfected people to estimate the link between SARS-CoV-2 infection and cognitive/executive dysfunction.

The authors noted that the survey was conducted from Sept. 28 to Oct. 21, 2021, when the primary variant in Canada was Delta.

The research was a cross-sectional observational study with data from the ongoing Canadian COVID-19 Experiences Survey. It included equal representation of vaccinated and vaccine-hesitant adults aged 18-54 years. COVID-19 symptoms ranged from negligible to life-threatening cases requiring hospitalization.

Half in the cohort (50.2%) received two vaccine shots; 43.3% had received no shots; and 5.5% received one shot, but were not intending to receive a second shot.
 

Dose-response relationship

According to the paper, those with prior COVID-19 infection, regardless of symptom severity, reported a significantly higher number of symptoms of executive dysfunction than their noninfected counterparts (mechanical adjustment, 1.63, standard error, 0.08; 95% confidence interval, 1.47-1.80; P = .001).

The researchers also found a dose-response relationship between COVID-19 symptom severity and cognitive dysfunction. Those with moderate and very/extremely severe COVID-19 symptoms were linked with significantly greater dysfunction.

“This reinforces what we’re hearing about – that COVID is not ‘one and done.’ It can have lasting and quite subtle and damaging effects on the human body,” William Schaffner, MD, infectious disease specialist with Vanderbilt University, Nashville, Tenn., said in an interview.

Measuring executive functioning – including the ability to make sound decisions – is something other studies haven’t typically addressed, he said.

Men were likely to report more cognitive dysfunction symptoms than women (beta, 0.15; P < .001). Younger adults (25-39 years) were more likely to experience cognitive dysfunction than those age 40-54 (beta, 0.30; P < .001).

Dr. Schaffner said it was troubling that young people are more likely to experience the dysfunction.

“When we think of ‘brain fog’ we think of older persons who are already predisposed to have more memory lapses as they get older,” he said.

The link between cognitive dysfunction and COVID-19 infection has been shown in other studies, but many have not used representative samples and have not compared results with noninfected controls in the general population, the authors wrote.

Executive dysfunction was measured using four questions from the Deficits in Executive Functioning Scale. Respondents were asked how often they have experienced these scenarios in the past 6 months:
 

• “I am unable to inhibit my reactions or responses to events or to other people.”
• “I make impulsive comments to others.”
• “I am likely to do things without considering the consequences for doing them.”
• “I act without thinking.”

“This makes it even more important that we talk about vaccination,” Dr. Schaffner said, “because clearly the more seriously ill you are, the more likely this sort of thing is likely to happen and vaccines have been shown time and again to avert hospitalizations and more serious illness. It also makes more important the monoclonal antibody treatments we have and the antivirals, which will prevent the evolution of mild disease into something more serious.”

This research was supported by a grant from the Canadian Institutes for Health Research, Institute for Population and Public Health. The study authors and Dr. Schaffner disclosed no relevant financial relationships.

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

For many adolescents, the first visit to a gynecologist can be intimidating. The prospect of meeting a new doctor who will ask prying, deeply personal questions about sex and menstruation is scary. And, in all likelihood, a parent, older sibling, or friend has warned them about the notorious pelvic exam.

The exact timing of when adolescent patients should start seeing a gynecologist varies based on when a patient starts puberty. Primary care physicians and pediatricians can help teens transition by referring patients to an adolescent-friendly practice and clearing up some of the misconceptions that surround the first gynecology visit. Gynecologists, on the other side of the referral, can help patients transition by guaranteeing confidentiality and creating a safe space for young patients.

This news organization interviewed three experts in adolescent health about when teens should start having their gynecological needs addressed and how their physicians can help them undergo that transition.
 

Age-appropriate care

“Most people get very limited information about their reproductive health,” said Anne-Marie E. Amies Oelschlager, MD, a pediatric and adolescent gynecologist at Seattle Children’s, Seattle, and a member of the American College of Obstetricians and Gynecologists (ACOG) clinical consensus committee on gynecology.

Official guidelines from ACOG call for the initial reproductive health visit to take place between the ages of 13 and 15 years. The exact age may vary, however, depending on the specific needs of the patient.

For example, some patients begin menstruating early, at age 9 or 10, said Mary Romano, MD, MPH, a pediatrician and adolescent medicine specialist at Vanderbilt Children’s Hospital, Nashville, Tenn. Pediatricians who are uncomfortable educating young patients about menstruation should refer the patient to a gynecologist or a pediatric gynecologist for whom such discussions are routine.

If a patient does not have a menstrual cycle by age 14 or 15, that also should be addressed by a family physician or gynecologist, Dr. Romano added.

“The importance here is addressing the reproductive health of the teen starting really at the age of 10 or 12, or once puberty starts,” said Patricia S. Huguelet, MD, a pediatric and adolescent gynecologist at Children’s Hospital Colorado, Aurora. In those early visits, the physician can provide “anticipatory guidance,” counseling the teen on what is normal in terms of menstruation, sex, and relationships, and addressing what is not, she said.

Ideally, patients who were designated female at birth but now identify as male or nonbinary will meet with a gynecologist early on in the gender affirmation process and a gynecologist will continue to consult as part of the patient’s interdisciplinary care team, added Dr. Romano, who counsels LGBTQ+ youth as part of her practice. A gynecologist may support these patients in myriad ways, including helping those who are considering or using puberty blockers and providing reproductive and health education to patients in a way that is sensitive to the patient’s gender identity.
 

Patient referrals

Some pediatricians and family practice physicians may be talking with their patients about topics such as menstrual cycles and contraception. But those who are uncomfortable asking adolescent patients about their reproductive and sexual health should refer them to a gynecologist or specialist in adolescent medicine, Dr. Romano advised.

“The biggest benefit I’ve noticed is often [patients] come from a pediatrician or family medicine provider and they often appreciate the opportunity to talk to a doctor they haven’t met before about the more personal questions they may have,” Dr. Amies Oelschlager said.

Referring adolescents to a specialist who has either trained in adolescent medicine or has experience treating that age group has benefits, Dr. Romano said. Clinicians with that experience understand adolescents are not “mini-adults” but have unique developmental and medical issues. How to counsel and educate them carries unique challenges, she said.

For example, heavy menstrual bleeding is a leading reason a patient – either an adult or an adolescent – presents to a gynecologist, Dr. Huguelet said. But the pathology differs vastly for those two age groups. For patients in their 30s and 40s, polyps and fibroids are common problems associated with heavy bleeding. Those conditions are rare in adolescents, whereas bleeding disorders are common, she said.

Most patients will continue to see their pediatricians and primary care providers for other issues. And in some areas, gynecologists can reinforce advice from pediatricians, such as encouraging patients to get the HPV vaccine, Dr. Amies Oelschlager said.
 

Common misconceptions

Primary care physicians can also dispel common misconceptions teens – and their parents – have about gynecology. Some parents may believe that certain methods of birth control cause cancer or infertility, have concerns about the HPV vaccine, or think hormonal therapies are harmful, Dr. Amies Oelschlager said. But the biggest misconception involves the infamous pelvic exam.

“Lots of patients assume that every time they go to the gynecologist they are going to have a pelvic exam,” she said. “When I say, ‘We don’t have to do that,’ they are so relieved.”

Guidelines have changed since the parents of today’s teens were going to the gynecologist for the first time. Many patients now do not need an initial Pap smear until age 25, following a recent guideline change by the American Cancer Society. (ACOG is considering adopting the same stance but still recommends screening start at 21.) “Most patients do not need an exam, even when it comes to sexual health and screening [for sexually transmitted infections], that can be done without an exam,” Dr. Huguelet said.
 

Confidentiality and comfort

On the other side of the referral, gynecologists should follow several best practices to treat adolescent patients. Arguably the most important part of the initial gynecologic visit is to give patients the option of one-on-one time with the physician with no parent in the room. During that time, the physician should make it clear that what they discuss is confidential and will not be shared with their parent or guardian, Dr. Huguelet said. Patients should also have the option of having a friend or another nonparent individual in the room with them during this one-on-one time with the physician, particularly if the patient does not feel comfortable discussing sensitive subjects completely on her own.

Adolescents receive better care, disclose more, and perceive they are getting better care when the process is confidential, Dr. Romano said. Confidentiality does have limits, however, which physicians should also make sure their patients understand, according to the ACOG guidelines for the initial reproductive visit. These limitations can vary by state depending on issues related to mandatory reporting, insurance billing, and legal requirements of patient notifications of specific services such as abortion.

The use of electronic medical records has raised additional challenges when it comes to communicating privately with adolescent patients, Dr. Amies Oelschlager said. In her practice, she tries to ensure the adolescent is the one with the login information for their records. If not, her office will have the patient’s cell number to text or call securely.

“We feel strongly adolescents should be able to access reproductive health care, mental health care, and care for substance abuse disorders without parental notification,” Dr. Amies Oelschlager said.

Telehealth visits can also be helpful for adolescents coming to gynecology for the first time. And taking the time to establish a rapport with patients at the start of the visit is key, Dr. Huguelet said. By directing questions to the adolescent patient rather than the parent, Dr. Huguelet said, the physician demonstrates that the teen’s treatment needs come first.

ACOG has guidelines on other steps gynecology practices, including those that see both adults and teens, can take to make their offices and visits adolescent-friendly. These steps include asking patients about their preferred names and pronouns at the start of the visit or as part of the initial intake form, training office staff to be comfortable with issues related to adolescent sexuality and gender and sexual diversity among patients, providing a place for teens to wait separately from obstetrics patients, and having age-appropriate literature on hand for adolescents to learn about reproductive health.

After that first reproductive health visit, gynecologists and primary care providers should partner to ensure the whole health of their patients is being addressed, Dr. Huguelet said.

“Collaboration is always going to better serve patients in any area,” said Dr. Romano, “and certainly this area is no different.”

Dr. Amies Oelschlager, Dr. Romano, and Dr. Huguelet have disclosed no relevant financial relationships.

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

For many adolescents, the first visit to a gynecologist can be intimidating. The prospect of meeting a new doctor who will ask prying, deeply personal questions about sex and menstruation is scary. And, in all likelihood, a parent, older sibling, or friend has warned them about the notorious pelvic exam.

The exact timing of when adolescent patients should start seeing a gynecologist varies based on when a patient starts puberty. Primary care physicians and pediatricians can help teens transition by referring patients to an adolescent-friendly practice and clearing up some of the misconceptions that surround the first gynecology visit. Gynecologists, on the other side of the referral, can help patients transition by guaranteeing confidentiality and creating a safe space for young patients.

This news organization interviewed three experts in adolescent health about when teens should start having their gynecological needs addressed and how their physicians can help them undergo that transition.
 

Age-appropriate care

“Most people get very limited information about their reproductive health,” said Anne-Marie E. Amies Oelschlager, MD, a pediatric and adolescent gynecologist at Seattle Children’s, Seattle, and a member of the American College of Obstetricians and Gynecologists (ACOG) clinical consensus committee on gynecology.

Official guidelines from ACOG call for the initial reproductive health visit to take place between the ages of 13 and 15 years. The exact age may vary, however, depending on the specific needs of the patient.

For example, some patients begin menstruating early, at age 9 or 10, said Mary Romano, MD, MPH, a pediatrician and adolescent medicine specialist at Vanderbilt Children’s Hospital, Nashville, Tenn. Pediatricians who are uncomfortable educating young patients about menstruation should refer the patient to a gynecologist or a pediatric gynecologist for whom such discussions are routine.

If a patient does not have a menstrual cycle by age 14 or 15, that also should be addressed by a family physician or gynecologist, Dr. Romano added.

“The importance here is addressing the reproductive health of the teen starting really at the age of 10 or 12, or once puberty starts,” said Patricia S. Huguelet, MD, a pediatric and adolescent gynecologist at Children’s Hospital Colorado, Aurora. In those early visits, the physician can provide “anticipatory guidance,” counseling the teen on what is normal in terms of menstruation, sex, and relationships, and addressing what is not, she said.

Ideally, patients who were designated female at birth but now identify as male or nonbinary will meet with a gynecologist early on in the gender affirmation process and a gynecologist will continue to consult as part of the patient’s interdisciplinary care team, added Dr. Romano, who counsels LGBTQ+ youth as part of her practice. A gynecologist may support these patients in myriad ways, including helping those who are considering or using puberty blockers and providing reproductive and health education to patients in a way that is sensitive to the patient’s gender identity.
 

Patient referrals

Some pediatricians and family practice physicians may be talking with their patients about topics such as menstrual cycles and contraception. But those who are uncomfortable asking adolescent patients about their reproductive and sexual health should refer them to a gynecologist or specialist in adolescent medicine, Dr. Romano advised.

“The biggest benefit I’ve noticed is often [patients] come from a pediatrician or family medicine provider and they often appreciate the opportunity to talk to a doctor they haven’t met before about the more personal questions they may have,” Dr. Amies Oelschlager said.

Referring adolescents to a specialist who has either trained in adolescent medicine or has experience treating that age group has benefits, Dr. Romano said. Clinicians with that experience understand adolescents are not “mini-adults” but have unique developmental and medical issues. How to counsel and educate them carries unique challenges, she said.

For example, heavy menstrual bleeding is a leading reason a patient – either an adult or an adolescent – presents to a gynecologist, Dr. Huguelet said. But the pathology differs vastly for those two age groups. For patients in their 30s and 40s, polyps and fibroids are common problems associated with heavy bleeding. Those conditions are rare in adolescents, whereas bleeding disorders are common, she said.

Most patients will continue to see their pediatricians and primary care providers for other issues. And in some areas, gynecologists can reinforce advice from pediatricians, such as encouraging patients to get the HPV vaccine, Dr. Amies Oelschlager said.
 

Common misconceptions

Primary care physicians can also dispel common misconceptions teens – and their parents – have about gynecology. Some parents may believe that certain methods of birth control cause cancer or infertility, have concerns about the HPV vaccine, or think hormonal therapies are harmful, Dr. Amies Oelschlager said. But the biggest misconception involves the infamous pelvic exam.

“Lots of patients assume that every time they go to the gynecologist they are going to have a pelvic exam,” she said. “When I say, ‘We don’t have to do that,’ they are so relieved.”

Guidelines have changed since the parents of today’s teens were going to the gynecologist for the first time. Many patients now do not need an initial Pap smear until age 25, following a recent guideline change by the American Cancer Society. (ACOG is considering adopting the same stance but still recommends screening start at 21.) “Most patients do not need an exam, even when it comes to sexual health and screening [for sexually transmitted infections], that can be done without an exam,” Dr. Huguelet said.
 

Confidentiality and comfort

On the other side of the referral, gynecologists should follow several best practices to treat adolescent patients. Arguably the most important part of the initial gynecologic visit is to give patients the option of one-on-one time with the physician with no parent in the room. During that time, the physician should make it clear that what they discuss is confidential and will not be shared with their parent or guardian, Dr. Huguelet said. Patients should also have the option of having a friend or another nonparent individual in the room with them during this one-on-one time with the physician, particularly if the patient does not feel comfortable discussing sensitive subjects completely on her own.

Adolescents receive better care, disclose more, and perceive they are getting better care when the process is confidential, Dr. Romano said. Confidentiality does have limits, however, which physicians should also make sure their patients understand, according to the ACOG guidelines for the initial reproductive visit. These limitations can vary by state depending on issues related to mandatory reporting, insurance billing, and legal requirements of patient notifications of specific services such as abortion.

The use of electronic medical records has raised additional challenges when it comes to communicating privately with adolescent patients, Dr. Amies Oelschlager said. In her practice, she tries to ensure the adolescent is the one with the login information for their records. If not, her office will have the patient’s cell number to text or call securely.

“We feel strongly adolescents should be able to access reproductive health care, mental health care, and care for substance abuse disorders without parental notification,” Dr. Amies Oelschlager said.

Telehealth visits can also be helpful for adolescents coming to gynecology for the first time. And taking the time to establish a rapport with patients at the start of the visit is key, Dr. Huguelet said. By directing questions to the adolescent patient rather than the parent, Dr. Huguelet said, the physician demonstrates that the teen’s treatment needs come first.

ACOG has guidelines on other steps gynecology practices, including those that see both adults and teens, can take to make their offices and visits adolescent-friendly. These steps include asking patients about their preferred names and pronouns at the start of the visit or as part of the initial intake form, training office staff to be comfortable with issues related to adolescent sexuality and gender and sexual diversity among patients, providing a place for teens to wait separately from obstetrics patients, and having age-appropriate literature on hand for adolescents to learn about reproductive health.

After that first reproductive health visit, gynecologists and primary care providers should partner to ensure the whole health of their patients is being addressed, Dr. Huguelet said.

“Collaboration is always going to better serve patients in any area,” said Dr. Romano, “and certainly this area is no different.”

Dr. Amies Oelschlager, Dr. Romano, and Dr. Huguelet have disclosed no relevant financial relationships.

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

For many adolescents, the first visit to a gynecologist can be intimidating. The prospect of meeting a new doctor who will ask prying, deeply personal questions about sex and menstruation is scary. And, in all likelihood, a parent, older sibling, or friend has warned them about the notorious pelvic exam.

The exact timing of when adolescent patients should start seeing a gynecologist varies based on when a patient starts puberty. Primary care physicians and pediatricians can help teens transition by referring patients to an adolescent-friendly practice and clearing up some of the misconceptions that surround the first gynecology visit. Gynecologists, on the other side of the referral, can help patients transition by guaranteeing confidentiality and creating a safe space for young patients.

This news organization interviewed three experts in adolescent health about when teens should start having their gynecological needs addressed and how their physicians can help them undergo that transition.
 

Age-appropriate care

“Most people get very limited information about their reproductive health,” said Anne-Marie E. Amies Oelschlager, MD, a pediatric and adolescent gynecologist at Seattle Children’s, Seattle, and a member of the American College of Obstetricians and Gynecologists (ACOG) clinical consensus committee on gynecology.

Official guidelines from ACOG call for the initial reproductive health visit to take place between the ages of 13 and 15 years. The exact age may vary, however, depending on the specific needs of the patient.

For example, some patients begin menstruating early, at age 9 or 10, said Mary Romano, MD, MPH, a pediatrician and adolescent medicine specialist at Vanderbilt Children’s Hospital, Nashville, Tenn. Pediatricians who are uncomfortable educating young patients about menstruation should refer the patient to a gynecologist or a pediatric gynecologist for whom such discussions are routine.

If a patient does not have a menstrual cycle by age 14 or 15, that also should be addressed by a family physician or gynecologist, Dr. Romano added.

“The importance here is addressing the reproductive health of the teen starting really at the age of 10 or 12, or once puberty starts,” said Patricia S. Huguelet, MD, a pediatric and adolescent gynecologist at Children’s Hospital Colorado, Aurora. In those early visits, the physician can provide “anticipatory guidance,” counseling the teen on what is normal in terms of menstruation, sex, and relationships, and addressing what is not, she said.

Ideally, patients who were designated female at birth but now identify as male or nonbinary will meet with a gynecologist early on in the gender affirmation process and a gynecologist will continue to consult as part of the patient’s interdisciplinary care team, added Dr. Romano, who counsels LGBTQ+ youth as part of her practice. A gynecologist may support these patients in myriad ways, including helping those who are considering or using puberty blockers and providing reproductive and health education to patients in a way that is sensitive to the patient’s gender identity.
 

Patient referrals

Some pediatricians and family practice physicians may be talking with their patients about topics such as menstrual cycles and contraception. But those who are uncomfortable asking adolescent patients about their reproductive and sexual health should refer them to a gynecologist or specialist in adolescent medicine, Dr. Romano advised.

“The biggest benefit I’ve noticed is often [patients] come from a pediatrician or family medicine provider and they often appreciate the opportunity to talk to a doctor they haven’t met before about the more personal questions they may have,” Dr. Amies Oelschlager said.

Referring adolescents to a specialist who has either trained in adolescent medicine or has experience treating that age group has benefits, Dr. Romano said. Clinicians with that experience understand adolescents are not “mini-adults” but have unique developmental and medical issues. How to counsel and educate them carries unique challenges, she said.

For example, heavy menstrual bleeding is a leading reason a patient – either an adult or an adolescent – presents to a gynecologist, Dr. Huguelet said. But the pathology differs vastly for those two age groups. For patients in their 30s and 40s, polyps and fibroids are common problems associated with heavy bleeding. Those conditions are rare in adolescents, whereas bleeding disorders are common, she said.

Most patients will continue to see their pediatricians and primary care providers for other issues. And in some areas, gynecologists can reinforce advice from pediatricians, such as encouraging patients to get the HPV vaccine, Dr. Amies Oelschlager said.
 

Common misconceptions

Primary care physicians can also dispel common misconceptions teens – and their parents – have about gynecology. Some parents may believe that certain methods of birth control cause cancer or infertility, have concerns about the HPV vaccine, or think hormonal therapies are harmful, Dr. Amies Oelschlager said. But the biggest misconception involves the infamous pelvic exam.

“Lots of patients assume that every time they go to the gynecologist they are going to have a pelvic exam,” she said. “When I say, ‘We don’t have to do that,’ they are so relieved.”

Guidelines have changed since the parents of today’s teens were going to the gynecologist for the first time. Many patients now do not need an initial Pap smear until age 25, following a recent guideline change by the American Cancer Society. (ACOG is considering adopting the same stance but still recommends screening start at 21.) “Most patients do not need an exam, even when it comes to sexual health and screening [for sexually transmitted infections], that can be done without an exam,” Dr. Huguelet said.
 

Confidentiality and comfort

On the other side of the referral, gynecologists should follow several best practices to treat adolescent patients. Arguably the most important part of the initial gynecologic visit is to give patients the option of one-on-one time with the physician with no parent in the room. During that time, the physician should make it clear that what they discuss is confidential and will not be shared with their parent or guardian, Dr. Huguelet said. Patients should also have the option of having a friend or another nonparent individual in the room with them during this one-on-one time with the physician, particularly if the patient does not feel comfortable discussing sensitive subjects completely on her own.

Adolescents receive better care, disclose more, and perceive they are getting better care when the process is confidential, Dr. Romano said. Confidentiality does have limits, however, which physicians should also make sure their patients understand, according to the ACOG guidelines for the initial reproductive visit. These limitations can vary by state depending on issues related to mandatory reporting, insurance billing, and legal requirements of patient notifications of specific services such as abortion.

The use of electronic medical records has raised additional challenges when it comes to communicating privately with adolescent patients, Dr. Amies Oelschlager said. In her practice, she tries to ensure the adolescent is the one with the login information for their records. If not, her office will have the patient’s cell number to text or call securely.

“We feel strongly adolescents should be able to access reproductive health care, mental health care, and care for substance abuse disorders without parental notification,” Dr. Amies Oelschlager said.

Telehealth visits can also be helpful for adolescents coming to gynecology for the first time. And taking the time to establish a rapport with patients at the start of the visit is key, Dr. Huguelet said. By directing questions to the adolescent patient rather than the parent, Dr. Huguelet said, the physician demonstrates that the teen’s treatment needs come first.

ACOG has guidelines on other steps gynecology practices, including those that see both adults and teens, can take to make their offices and visits adolescent-friendly. These steps include asking patients about their preferred names and pronouns at the start of the visit or as part of the initial intake form, training office staff to be comfortable with issues related to adolescent sexuality and gender and sexual diversity among patients, providing a place for teens to wait separately from obstetrics patients, and having age-appropriate literature on hand for adolescents to learn about reproductive health.

After that first reproductive health visit, gynecologists and primary care providers should partner to ensure the whole health of their patients is being addressed, Dr. Huguelet said.

“Collaboration is always going to better serve patients in any area,” said Dr. Romano, “and certainly this area is no different.”

Dr. Amies Oelschlager, Dr. Romano, and Dr. Huguelet have disclosed no relevant financial relationships.

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

Less can sometimes be more. New findings show that low-dose postoperative radiation therapy following transoral surgery led to “outstanding oncologic outcome and favorable functional outcomes” in patients with intermediate-risk human papillomavirus (HPV) and oropharynx cancer.

In the phase 2 trial, 95% of patients with locally advanced oropharynx cancer and HPV remained progression free at 2 years following reduced-dose radiation therapy (50 Gy), compared with 96% of patients receiving standard-dose radiation therapy (60 Gy). Both groups avoided chemotherapy as well.

The results, published in the Journal of Clinical Oncology, suggest that postoperative radiation therapy at 50 Gy without chemotherapy was safe and effective in this intermediate-risk subset of patients, the authors concluded.

Although it’s hard for one trial to define standard of care, this study “may be an example of a practice-changing phase 2 [trial],” said lead author Robert L. Ferris, MD, PhD, director of the University of Pittsburgh Medical Center Hillman Cancer Center. “We and others have adopted 50 Gy without chemo as our adjuvant treatment for up to 4 positive nodes and 1 mm of extranodal extension.”

Treatment deintensification for patients with HPV and oropharynx cancer is an active area of investigation, but whether undergoing transoral surgery can allow intermediate-risk patients to receive a lower dose of adjuvant therapy remains uncertain.

Recent results from a phase 3 trial, presented during the plenary session at the 2021 annual meeting of the American Society for Radiation Oncology, showed that de-escalated adjuvant radiation therapy resulted in robust responses and lower toxicity as compared with standard care radiotherapy in patients with HPV and oropharyngeal squamous cell carcinoma.

The goal of the current ECON-ACRIN (E3311) trial was to prospectively assess the 2-year progression-free survival of transoral surgery and reduced adjuvant therapy in intermediate-risk patients with HPV and oropharynx cancer.

The phase 2 trial included 359 patients with HPV and oropharynx cancer who underwent surgery and were then assigned to one of four treatment groups based on individual risk factors for recurrence: low-risk patients under observation (arm A); intermediate-risk patients receiving low-dose radiation therapy (50 Gy, arm B) and those receiving standard-dose radiation (60 Gy, arm C) both without chemotherapy; and finally high-risk patients receiving chemotherapy in combination with high-dose radiation (arm D).

Among patients who underwent transoral surgery, 11% were assigned to arm A, 28% and 30% were randomly allocated to arms B and C, respectively, and 31% were assigned to arm D. For those who underwent transoral laser microsurgery, 11% were assigned to arm A, 32% and 24% were randomly allocated to arms B and C, respectively, and 34% were assigned to arm D.

Almost all patients (95%) in arm B remained progression free at 2 years after receiving reduced-dose radiation therapy. This rate of progression-free survival aligned with those observed in the other cohorts: 91% in high-risk patients receiving chemotherapy in combination with standard 66 Gy high-dose radiation, 96% in intermediate-risk patients in the 60 Gy standard-dose radiation arm, and 97% in the low-risk observation arm.

Although progression-free survival did not differ statistically between the arms (P = .90 for B vs. C; P = .30 for B vs. D; P = .30 for C vs. D), the authors urged caution when interpreting the results because the study was not powered to compare arms B and C directly.

Overall, these results show that “we could reduce radiation therapy and eliminate chemotherapy for 70% of patients,” Dr. Ferris said in an interview. Plus, “a small group of the lowest-risk [patients] did well with surgery alone.”

Regarding outcomes for quality of life (functional assessment of cancer therapy–head and neck) and swallowing (MD Anderson Dysphagia Index), patients reported a consistent decline in both during treatment. Patient scores, however, recovered to baseline levels in arms A-C and remained slightly lower after adjuvant therapy in arm D; however, it is unknown whether differences will emerge over a longer-term period.

Bhishamjit S. Chera, MD, an associate professor and radiation oncologist at the University of North Carolina at Chapel Hill, noted that reduced doses are not the current standard of care but it’s the “direction we’re headed.”

“I have started to use lower doses in selected patients” and other experts are offering it as well, said Dr. Chera, who was not involved in the research.

He also said that patients appear very interested in participating in lower-intensity therapy, judging by how rapidly accrual is for clinical trials of this nature.

However, caution is warranted.

“You have to be careful when you reduce intensity and there are different ways of doing it,” Dr. Chera said. “It’s not ready for community practice, and if it is offered to patients, it needs to be explained carefully with informed consent.”

The study was supported by the National Cancer Institute of the National Institutes of Health. Dr. Ferris has disclosed relationships Novasenta, Merck, Pfizer, EMD Serono, Numab, Macrogenics, Aduro Biotech, Sanofi, Zymeworks, Bristol-Myers Squibb, AstraZeneca/MedImmune, and Tesaro. Dr. Chera disclosed stock and other ownership interests in Naveris, and a consulting or advisory role with Naveris. He is a coinventor on a patent application regarding a method for measuring tumor-derived viral nucleic acids in blood samples, which is owned by the University of North Carolina at Chapel Hill and licensed to Naveris.

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

Less can sometimes be more. New findings show that low-dose postoperative radiation therapy following transoral surgery led to “outstanding oncologic outcome and favorable functional outcomes” in patients with intermediate-risk human papillomavirus (HPV) and oropharynx cancer.

In the phase 2 trial, 95% of patients with locally advanced oropharynx cancer and HPV remained progression free at 2 years following reduced-dose radiation therapy (50 Gy), compared with 96% of patients receiving standard-dose radiation therapy (60 Gy). Both groups avoided chemotherapy as well.

The results, published in the Journal of Clinical Oncology, suggest that postoperative radiation therapy at 50 Gy without chemotherapy was safe and effective in this intermediate-risk subset of patients, the authors concluded.

Although it’s hard for one trial to define standard of care, this study “may be an example of a practice-changing phase 2 [trial],” said lead author Robert L. Ferris, MD, PhD, director of the University of Pittsburgh Medical Center Hillman Cancer Center. “We and others have adopted 50 Gy without chemo as our adjuvant treatment for up to 4 positive nodes and 1 mm of extranodal extension.”

Treatment deintensification for patients with HPV and oropharynx cancer is an active area of investigation, but whether undergoing transoral surgery can allow intermediate-risk patients to receive a lower dose of adjuvant therapy remains uncertain.

Recent results from a phase 3 trial, presented during the plenary session at the 2021 annual meeting of the American Society for Radiation Oncology, showed that de-escalated adjuvant radiation therapy resulted in robust responses and lower toxicity as compared with standard care radiotherapy in patients with HPV and oropharyngeal squamous cell carcinoma.

The goal of the current ECON-ACRIN (E3311) trial was to prospectively assess the 2-year progression-free survival of transoral surgery and reduced adjuvant therapy in intermediate-risk patients with HPV and oropharynx cancer.

The phase 2 trial included 359 patients with HPV and oropharynx cancer who underwent surgery and were then assigned to one of four treatment groups based on individual risk factors for recurrence: low-risk patients under observation (arm A); intermediate-risk patients receiving low-dose radiation therapy (50 Gy, arm B) and those receiving standard-dose radiation (60 Gy, arm C) both without chemotherapy; and finally high-risk patients receiving chemotherapy in combination with high-dose radiation (arm D).

Among patients who underwent transoral surgery, 11% were assigned to arm A, 28% and 30% were randomly allocated to arms B and C, respectively, and 31% were assigned to arm D. For those who underwent transoral laser microsurgery, 11% were assigned to arm A, 32% and 24% were randomly allocated to arms B and C, respectively, and 34% were assigned to arm D.

Almost all patients (95%) in arm B remained progression free at 2 years after receiving reduced-dose radiation therapy. This rate of progression-free survival aligned with those observed in the other cohorts: 91% in high-risk patients receiving chemotherapy in combination with standard 66 Gy high-dose radiation, 96% in intermediate-risk patients in the 60 Gy standard-dose radiation arm, and 97% in the low-risk observation arm.

Although progression-free survival did not differ statistically between the arms (P = .90 for B vs. C; P = .30 for B vs. D; P = .30 for C vs. D), the authors urged caution when interpreting the results because the study was not powered to compare arms B and C directly.

Overall, these results show that “we could reduce radiation therapy and eliminate chemotherapy for 70% of patients,” Dr. Ferris said in an interview. Plus, “a small group of the lowest-risk [patients] did well with surgery alone.”

Regarding outcomes for quality of life (functional assessment of cancer therapy–head and neck) and swallowing (MD Anderson Dysphagia Index), patients reported a consistent decline in both during treatment. Patient scores, however, recovered to baseline levels in arms A-C and remained slightly lower after adjuvant therapy in arm D; however, it is unknown whether differences will emerge over a longer-term period.

Bhishamjit S. Chera, MD, an associate professor and radiation oncologist at the University of North Carolina at Chapel Hill, noted that reduced doses are not the current standard of care but it’s the “direction we’re headed.”

“I have started to use lower doses in selected patients” and other experts are offering it as well, said Dr. Chera, who was not involved in the research.

He also said that patients appear very interested in participating in lower-intensity therapy, judging by how rapidly accrual is for clinical trials of this nature.

However, caution is warranted.

“You have to be careful when you reduce intensity and there are different ways of doing it,” Dr. Chera said. “It’s not ready for community practice, and if it is offered to patients, it needs to be explained carefully with informed consent.”

The study was supported by the National Cancer Institute of the National Institutes of Health. Dr. Ferris has disclosed relationships Novasenta, Merck, Pfizer, EMD Serono, Numab, Macrogenics, Aduro Biotech, Sanofi, Zymeworks, Bristol-Myers Squibb, AstraZeneca/MedImmune, and Tesaro. Dr. Chera disclosed stock and other ownership interests in Naveris, and a consulting or advisory role with Naveris. He is a coinventor on a patent application regarding a method for measuring tumor-derived viral nucleic acids in blood samples, which is owned by the University of North Carolina at Chapel Hill and licensed to Naveris.

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

Less can sometimes be more. New findings show that low-dose postoperative radiation therapy following transoral surgery led to “outstanding oncologic outcome and favorable functional outcomes” in patients with intermediate-risk human papillomavirus (HPV) and oropharynx cancer.

In the phase 2 trial, 95% of patients with locally advanced oropharynx cancer and HPV remained progression free at 2 years following reduced-dose radiation therapy (50 Gy), compared with 96% of patients receiving standard-dose radiation therapy (60 Gy). Both groups avoided chemotherapy as well.

The results, published in the Journal of Clinical Oncology, suggest that postoperative radiation therapy at 50 Gy without chemotherapy was safe and effective in this intermediate-risk subset of patients, the authors concluded.

Although it’s hard for one trial to define standard of care, this study “may be an example of a practice-changing phase 2 [trial],” said lead author Robert L. Ferris, MD, PhD, director of the University of Pittsburgh Medical Center Hillman Cancer Center. “We and others have adopted 50 Gy without chemo as our adjuvant treatment for up to 4 positive nodes and 1 mm of extranodal extension.”

Treatment deintensification for patients with HPV and oropharynx cancer is an active area of investigation, but whether undergoing transoral surgery can allow intermediate-risk patients to receive a lower dose of adjuvant therapy remains uncertain.

Recent results from a phase 3 trial, presented during the plenary session at the 2021 annual meeting of the American Society for Radiation Oncology, showed that de-escalated adjuvant radiation therapy resulted in robust responses and lower toxicity as compared with standard care radiotherapy in patients with HPV and oropharyngeal squamous cell carcinoma.

The goal of the current ECON-ACRIN (E3311) trial was to prospectively assess the 2-year progression-free survival of transoral surgery and reduced adjuvant therapy in intermediate-risk patients with HPV and oropharynx cancer.

The phase 2 trial included 359 patients with HPV and oropharynx cancer who underwent surgery and were then assigned to one of four treatment groups based on individual risk factors for recurrence: low-risk patients under observation (arm A); intermediate-risk patients receiving low-dose radiation therapy (50 Gy, arm B) and those receiving standard-dose radiation (60 Gy, arm C) both without chemotherapy; and finally high-risk patients receiving chemotherapy in combination with high-dose radiation (arm D).

Among patients who underwent transoral surgery, 11% were assigned to arm A, 28% and 30% were randomly allocated to arms B and C, respectively, and 31% were assigned to arm D. For those who underwent transoral laser microsurgery, 11% were assigned to arm A, 32% and 24% were randomly allocated to arms B and C, respectively, and 34% were assigned to arm D.

Almost all patients (95%) in arm B remained progression free at 2 years after receiving reduced-dose radiation therapy. This rate of progression-free survival aligned with those observed in the other cohorts: 91% in high-risk patients receiving chemotherapy in combination with standard 66 Gy high-dose radiation, 96% in intermediate-risk patients in the 60 Gy standard-dose radiation arm, and 97% in the low-risk observation arm.

Although progression-free survival did not differ statistically between the arms (P = .90 for B vs. C; P = .30 for B vs. D; P = .30 for C vs. D), the authors urged caution when interpreting the results because the study was not powered to compare arms B and C directly.

Overall, these results show that “we could reduce radiation therapy and eliminate chemotherapy for 70% of patients,” Dr. Ferris said in an interview. Plus, “a small group of the lowest-risk [patients] did well with surgery alone.”

Regarding outcomes for quality of life (functional assessment of cancer therapy–head and neck) and swallowing (MD Anderson Dysphagia Index), patients reported a consistent decline in both during treatment. Patient scores, however, recovered to baseline levels in arms A-C and remained slightly lower after adjuvant therapy in arm D; however, it is unknown whether differences will emerge over a longer-term period.

Bhishamjit S. Chera, MD, an associate professor and radiation oncologist at the University of North Carolina at Chapel Hill, noted that reduced doses are not the current standard of care but it’s the “direction we’re headed.”

“I have started to use lower doses in selected patients” and other experts are offering it as well, said Dr. Chera, who was not involved in the research.

He also said that patients appear very interested in participating in lower-intensity therapy, judging by how rapidly accrual is for clinical trials of this nature.

However, caution is warranted.

“You have to be careful when you reduce intensity and there are different ways of doing it,” Dr. Chera said. “It’s not ready for community practice, and if it is offered to patients, it needs to be explained carefully with informed consent.”

The study was supported by the National Cancer Institute of the National Institutes of Health. Dr. Ferris has disclosed relationships Novasenta, Merck, Pfizer, EMD Serono, Numab, Macrogenics, Aduro Biotech, Sanofi, Zymeworks, Bristol-Myers Squibb, AstraZeneca/MedImmune, and Tesaro. Dr. Chera disclosed stock and other ownership interests in Naveris, and a consulting or advisory role with Naveris. He is a coinventor on a patent application regarding a method for measuring tumor-derived viral nucleic acids in blood samples, which is owned by the University of North Carolina at Chapel Hill and licensed to Naveris.

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

In the clinical experience of Jonathan I. Silverberg, MD, PhD, MPH, atopic dermatitis (AD) patients with severe itch and mild to moderate lesions often fall through the cracks on the road to optimal treatment.

That’s because a disconnect often exists between clinician-reported and patient-reported outcome measures, Dr. Silverberg, director of clinical research in the division of dermatology at George Washington University School of Medicine and Health Sciences, said during the Revolutionizing Atopic Dermatitis virtual symposium. For example, multiple studies showed only weak to moderate correlations between the patient-focused Worst Itch Numeric Rating Scale (NRS) and Average Pruritus NRS compared with clinician-reported outcomes such as the Eczema Area and Severity Index (EASI), the objective SCORAD, body surface area (BSA), and the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), with only moderate correlation coefficients ranging from 0.3 to 0.6.

“These findings suggest that clinician-reported outcome measures are poor indicators of the patient experience,” he said. “We need to do a better job capturing patient-reported outcomes to understand how patients are impacted. But there’s something more novel to this because the weak correlations may also suggest that itch and other symptoms follow a different course than the signs of the disease. Just because the lesions flare up doesn’t mean the itch does, and vice versa. Anecdotally, this came up at many patient encounters where the skin looked good, but the patient was miserable with itch.”

To understand how the combination of itch and lesion severity predicts the severity assessment, longitudinal course, burden, and treatment of AD, Dr. Silverberg and colleagues prospectively evaluated 592 adults with AD . They defined four different AD subsets using the verbal rating scale for NRS average itch combined with either the EASI, objective-SCORAD, or vIGA-AD as follows: mild-moderate itch and lesions (MI/ML), mild-moderate itch and severe lesions (MI/SL), severe itch and mild-moderate lesions (SI/ML; the itch dominant subset), and severe itch and lesions (SI/SL). They found that most patients had MI/ML (59.4%-62.3%), followed by SI/ML (21.3%-29.1%), SI/SL (6%-12.9%), and MI/SL (3.8%-6.4%). SI/ML was more common in female and Black patients.

In addition, patients with MI/SL or SI/ML described their AD as being more severe on patient global assessment and had poor quality of life (QOL) scores, while patients with SI/SL were most likely to describe their disease as severe and have poor QOL scores. Patients with SI/ML described their disease as being more severe overall, yet patients with MI/SL or SI/SL were far more likely to be assigned severe PGA scores by clinicians. “The patients who have severe itch and mild lesions consider their disease severe, but the clinician is missing it,” Dr. Silverberg said. “Occasionally they’re picking it up but they’re missing a lot of these severe itch cases when there are milder lesions.”

In other findings, patients who had baseline MI/SL, SI/ML, and SI/SL were associated with similar frequency of AD flares, periods of AD clearance/remission, more itch triggers, and longitudinal courses over time, “which is remarkable,” he said. “It means those that have severe itch, even when they have milder lesions, are going to have unstable, more persistent disease, and have a harder time keeping control of it, and are ultimately going to require systemic therapies.” In fact, most patients with SI/SL (57.8%-66.7%) and MI/SL (53.9%-57.7%) but fewer patients with MI/ML (36.7%-38.4%) and SI/ML (30.8%-32%) initiated systemic, biologic, or phototherapy for their AD during follow-up. “There is a real upshot here clinically, in that patients are just not getting stepped up appropriately to achieve better control of their disease when they have itch-dominant AD,” Dr. Silverberg said.

He described itch-dominant AD as a novel disease phenotype that requires further investigation. “Why is it that some patients are getting such severe itch and milder looking lesions?” he asked. “I don’t think it’s just a matter of poor outcome measures that we have. So, what is it? It’s not entirely clear. Clinically, itch-dominant AD is important as it relates to the issues of diversity and skin of color because in darker skin tones, we cannot easily appreciate erythema. We may totally miss the active lesions. I think that’s a big part of why we see this itch-dominant AD more commonly in Black patients. Therefore, it is so important to ask our patients about their symptoms and to assess the severity of itch. But, even if they have what we think are milder lesions and severe itch, we must recognize they may not be well controlled. They may not be happy. They may have poor quality of life, and they may need to be stepped up appropriately. We need a lot more information to guide the assessment and management of this important subset of patients.”

Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

[email protected]

In the clinical experience of Jonathan I. Silverberg, MD, PhD, MPH, atopic dermatitis (AD) patients with severe itch and mild to moderate lesions often fall through the cracks on the road to optimal treatment.

That’s because a disconnect often exists between clinician-reported and patient-reported outcome measures, Dr. Silverberg, director of clinical research in the division of dermatology at George Washington University School of Medicine and Health Sciences, said during the Revolutionizing Atopic Dermatitis virtual symposium. For example, multiple studies showed only weak to moderate correlations between the patient-focused Worst Itch Numeric Rating Scale (NRS) and Average Pruritus NRS compared with clinician-reported outcomes such as the Eczema Area and Severity Index (EASI), the objective SCORAD, body surface area (BSA), and the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), with only moderate correlation coefficients ranging from 0.3 to 0.6.

“These findings suggest that clinician-reported outcome measures are poor indicators of the patient experience,” he said. “We need to do a better job capturing patient-reported outcomes to understand how patients are impacted. But there’s something more novel to this because the weak correlations may also suggest that itch and other symptoms follow a different course than the signs of the disease. Just because the lesions flare up doesn’t mean the itch does, and vice versa. Anecdotally, this came up at many patient encounters where the skin looked good, but the patient was miserable with itch.”

To understand how the combination of itch and lesion severity predicts the severity assessment, longitudinal course, burden, and treatment of AD, Dr. Silverberg and colleagues prospectively evaluated 592 adults with AD . They defined four different AD subsets using the verbal rating scale for NRS average itch combined with either the EASI, objective-SCORAD, or vIGA-AD as follows: mild-moderate itch and lesions (MI/ML), mild-moderate itch and severe lesions (MI/SL), severe itch and mild-moderate lesions (SI/ML; the itch dominant subset), and severe itch and lesions (SI/SL). They found that most patients had MI/ML (59.4%-62.3%), followed by SI/ML (21.3%-29.1%), SI/SL (6%-12.9%), and MI/SL (3.8%-6.4%). SI/ML was more common in female and Black patients.

In addition, patients with MI/SL or SI/ML described their AD as being more severe on patient global assessment and had poor quality of life (QOL) scores, while patients with SI/SL were most likely to describe their disease as severe and have poor QOL scores. Patients with SI/ML described their disease as being more severe overall, yet patients with MI/SL or SI/SL were far more likely to be assigned severe PGA scores by clinicians. “The patients who have severe itch and mild lesions consider their disease severe, but the clinician is missing it,” Dr. Silverberg said. “Occasionally they’re picking it up but they’re missing a lot of these severe itch cases when there are milder lesions.”

In other findings, patients who had baseline MI/SL, SI/ML, and SI/SL were associated with similar frequency of AD flares, periods of AD clearance/remission, more itch triggers, and longitudinal courses over time, “which is remarkable,” he said. “It means those that have severe itch, even when they have milder lesions, are going to have unstable, more persistent disease, and have a harder time keeping control of it, and are ultimately going to require systemic therapies.” In fact, most patients with SI/SL (57.8%-66.7%) and MI/SL (53.9%-57.7%) but fewer patients with MI/ML (36.7%-38.4%) and SI/ML (30.8%-32%) initiated systemic, biologic, or phototherapy for their AD during follow-up. “There is a real upshot here clinically, in that patients are just not getting stepped up appropriately to achieve better control of their disease when they have itch-dominant AD,” Dr. Silverberg said.

He described itch-dominant AD as a novel disease phenotype that requires further investigation. “Why is it that some patients are getting such severe itch and milder looking lesions?” he asked. “I don’t think it’s just a matter of poor outcome measures that we have. So, what is it? It’s not entirely clear. Clinically, itch-dominant AD is important as it relates to the issues of diversity and skin of color because in darker skin tones, we cannot easily appreciate erythema. We may totally miss the active lesions. I think that’s a big part of why we see this itch-dominant AD more commonly in Black patients. Therefore, it is so important to ask our patients about their symptoms and to assess the severity of itch. But, even if they have what we think are milder lesions and severe itch, we must recognize they may not be well controlled. They may not be happy. They may have poor quality of life, and they may need to be stepped up appropriately. We need a lot more information to guide the assessment and management of this important subset of patients.”

Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

[email protected]

In the clinical experience of Jonathan I. Silverberg, MD, PhD, MPH, atopic dermatitis (AD) patients with severe itch and mild to moderate lesions often fall through the cracks on the road to optimal treatment.

That’s because a disconnect often exists between clinician-reported and patient-reported outcome measures, Dr. Silverberg, director of clinical research in the division of dermatology at George Washington University School of Medicine and Health Sciences, said during the Revolutionizing Atopic Dermatitis virtual symposium. For example, multiple studies showed only weak to moderate correlations between the patient-focused Worst Itch Numeric Rating Scale (NRS) and Average Pruritus NRS compared with clinician-reported outcomes such as the Eczema Area and Severity Index (EASI), the objective SCORAD, body surface area (BSA), and the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), with only moderate correlation coefficients ranging from 0.3 to 0.6.

“These findings suggest that clinician-reported outcome measures are poor indicators of the patient experience,” he said. “We need to do a better job capturing patient-reported outcomes to understand how patients are impacted. But there’s something more novel to this because the weak correlations may also suggest that itch and other symptoms follow a different course than the signs of the disease. Just because the lesions flare up doesn’t mean the itch does, and vice versa. Anecdotally, this came up at many patient encounters where the skin looked good, but the patient was miserable with itch.”

To understand how the combination of itch and lesion severity predicts the severity assessment, longitudinal course, burden, and treatment of AD, Dr. Silverberg and colleagues prospectively evaluated 592 adults with AD . They defined four different AD subsets using the verbal rating scale for NRS average itch combined with either the EASI, objective-SCORAD, or vIGA-AD as follows: mild-moderate itch and lesions (MI/ML), mild-moderate itch and severe lesions (MI/SL), severe itch and mild-moderate lesions (SI/ML; the itch dominant subset), and severe itch and lesions (SI/SL). They found that most patients had MI/ML (59.4%-62.3%), followed by SI/ML (21.3%-29.1%), SI/SL (6%-12.9%), and MI/SL (3.8%-6.4%). SI/ML was more common in female and Black patients.

In addition, patients with MI/SL or SI/ML described their AD as being more severe on patient global assessment and had poor quality of life (QOL) scores, while patients with SI/SL were most likely to describe their disease as severe and have poor QOL scores. Patients with SI/ML described their disease as being more severe overall, yet patients with MI/SL or SI/SL were far more likely to be assigned severe PGA scores by clinicians. “The patients who have severe itch and mild lesions consider their disease severe, but the clinician is missing it,” Dr. Silverberg said. “Occasionally they’re picking it up but they’re missing a lot of these severe itch cases when there are milder lesions.”

In other findings, patients who had baseline MI/SL, SI/ML, and SI/SL were associated with similar frequency of AD flares, periods of AD clearance/remission, more itch triggers, and longitudinal courses over time, “which is remarkable,” he said. “It means those that have severe itch, even when they have milder lesions, are going to have unstable, more persistent disease, and have a harder time keeping control of it, and are ultimately going to require systemic therapies.” In fact, most patients with SI/SL (57.8%-66.7%) and MI/SL (53.9%-57.7%) but fewer patients with MI/ML (36.7%-38.4%) and SI/ML (30.8%-32%) initiated systemic, biologic, or phototherapy for their AD during follow-up. “There is a real upshot here clinically, in that patients are just not getting stepped up appropriately to achieve better control of their disease when they have itch-dominant AD,” Dr. Silverberg said.

He described itch-dominant AD as a novel disease phenotype that requires further investigation. “Why is it that some patients are getting such severe itch and milder looking lesions?” he asked. “I don’t think it’s just a matter of poor outcome measures that we have. So, what is it? It’s not entirely clear. Clinically, itch-dominant AD is important as it relates to the issues of diversity and skin of color because in darker skin tones, we cannot easily appreciate erythema. We may totally miss the active lesions. I think that’s a big part of why we see this itch-dominant AD more commonly in Black patients. Therefore, it is so important to ask our patients about their symptoms and to assess the severity of itch. But, even if they have what we think are milder lesions and severe itch, we must recognize they may not be well controlled. They may not be happy. They may have poor quality of life, and they may need to be stepped up appropriately. We need a lot more information to guide the assessment and management of this important subset of patients.”

Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

[email protected]

As a physician first and a mental health clinician second, I hope to provide factual medical information on the Omicron variant to my patients, family members, and friends. I also try to remain curious instead of angry about why some choose not to vaccinate.

The most effective way to encourage people to obtain a vaccination is to use communication free of judgment and criticism, which allows a safe space for the unvaccinated to express their motivations and fears behind their current choice of not vaccinating and explore possible barriers to an alternative option that could lead to vaccination.

As an adult psychiatrist, ADHD specialist, and amateur COVID-19 expert, I’d like to offer 10 reasons why Omicron – which ironically means “small” in Latin, can still cause big destruction. Please share these 10 reasons with your patients.

• If you are not vaccinated, this virus will find you within the next few weeks and likely lead to severe symptoms.
• Long-haul symptoms from COVID-19 infection are still possible even for people who contract a milder case of the Omicron variant.
• The monoclonal antibody and antiviral treatments recently approved by the Food and Drug Administration for pre-exposure prevention of COVID-19 are limited. For many reasons, now is not the best time to play Russian roulette and intentionally get infected with a “mild” variant.
• There are not enough testing sites or over-the-counter rapid COVID tests available to keep up with the demand, and the latter are cost prohibitive for many people.
• Emergency care during the next few weeks for unforeseen non–COVID-related illnesses, such as a sudden heart attack or stroke, may be affected by the shortage of medical providers because of illness, quarantine, and burnout.
• There will be fewer first responders, including EMTs, police officers, and firefighters, because of COVID quarantines from illness and exposure.
• Although most Americans oppose temporary shutdowns, de facto shutdowns might be necessary because of the absence of healthy, COVID-negative individuals to maintain a functional society.
• Omicron math is deceiving, since the risk of hospitalization with Omicron appears to be far lower than with the Delta variant. However, the higher volume of infections with Omicron will offset the lower severity leading to comparable numbers of hospitalizations.
• Omicron has made it difficult for some schools to reopen after the holiday break, and reopening might become even more difficult as the surge progresses. Many schools already were in desperate need of substitute teachers, bus drivers, and additional staff necessary for COVID safety precautions before the emergence of the Omicron variant.
• And, for a less altruistic reason, as if the nine reasons above weren’t enough – if infections continue, especially among the unvaccinated – where the virus mutates the most – this can lead to a trifecta variant that not only evades the immune system and is highly infectious but causes severe disease in both the unvaccinated as well as the vaccinated.

Because of its extremely high transmissibility, the Omicron variant – layered atop Delta – presents great risk to us as a society. We must do all we can as clinicians to educate our patients so that they can protect themselves and their families.

Dr. Abraham is a psychiatrist in private practice in Philadelphia. She has no disclosures.

As a physician first and a mental health clinician second, I hope to provide factual medical information on the Omicron variant to my patients, family members, and friends. I also try to remain curious instead of angry about why some choose not to vaccinate.

The most effective way to encourage people to obtain a vaccination is to use communication free of judgment and criticism, which allows a safe space for the unvaccinated to express their motivations and fears behind their current choice of not vaccinating and explore possible barriers to an alternative option that could lead to vaccination.

As an adult psychiatrist, ADHD specialist, and amateur COVID-19 expert, I’d like to offer 10 reasons why Omicron – which ironically means “small” in Latin, can still cause big destruction. Please share these 10 reasons with your patients.

• If you are not vaccinated, this virus will find you within the next few weeks and likely lead to severe symptoms.
• Long-haul symptoms from COVID-19 infection are still possible even for people who contract a milder case of the Omicron variant.
• The monoclonal antibody and antiviral treatments recently approved by the Food and Drug Administration for pre-exposure prevention of COVID-19 are limited. For many reasons, now is not the best time to play Russian roulette and intentionally get infected with a “mild” variant.
• There are not enough testing sites or over-the-counter rapid COVID tests available to keep up with the demand, and the latter are cost prohibitive for many people.
• Emergency care during the next few weeks for unforeseen non–COVID-related illnesses, such as a sudden heart attack or stroke, may be affected by the shortage of medical providers because of illness, quarantine, and burnout.
• There will be fewer first responders, including EMTs, police officers, and firefighters, because of COVID quarantines from illness and exposure.
• Although most Americans oppose temporary shutdowns, de facto shutdowns might be necessary because of the absence of healthy, COVID-negative individuals to maintain a functional society.
• Omicron math is deceiving, since the risk of hospitalization with Omicron appears to be far lower than with the Delta variant. However, the higher volume of infections with Omicron will offset the lower severity leading to comparable numbers of hospitalizations.
• Omicron has made it difficult for some schools to reopen after the holiday break, and reopening might become even more difficult as the surge progresses. Many schools already were in desperate need of substitute teachers, bus drivers, and additional staff necessary for COVID safety precautions before the emergence of the Omicron variant.
• And, for a less altruistic reason, as if the nine reasons above weren’t enough – if infections continue, especially among the unvaccinated – where the virus mutates the most – this can lead to a trifecta variant that not only evades the immune system and is highly infectious but causes severe disease in both the unvaccinated as well as the vaccinated.

Because of its extremely high transmissibility, the Omicron variant – layered atop Delta – presents great risk to us as a society. We must do all we can as clinicians to educate our patients so that they can protect themselves and their families.

Dr. Abraham is a psychiatrist in private practice in Philadelphia. She has no disclosures.

As a physician first and a mental health clinician second, I hope to provide factual medical information on the Omicron variant to my patients, family members, and friends. I also try to remain curious instead of angry about why some choose not to vaccinate.

The most effective way to encourage people to obtain a vaccination is to use communication free of judgment and criticism, which allows a safe space for the unvaccinated to express their motivations and fears behind their current choice of not vaccinating and explore possible barriers to an alternative option that could lead to vaccination.

As an adult psychiatrist, ADHD specialist, and amateur COVID-19 expert, I’d like to offer 10 reasons why Omicron – which ironically means “small” in Latin, can still cause big destruction. Please share these 10 reasons with your patients.

• If you are not vaccinated, this virus will find you within the next few weeks and likely lead to severe symptoms.
• Long-haul symptoms from COVID-19 infection are still possible even for people who contract a milder case of the Omicron variant.
• The monoclonal antibody and antiviral treatments recently approved by the Food and Drug Administration for pre-exposure prevention of COVID-19 are limited. For many reasons, now is not the best time to play Russian roulette and intentionally get infected with a “mild” variant.
• There are not enough testing sites or over-the-counter rapid COVID tests available to keep up with the demand, and the latter are cost prohibitive for many people.
• Emergency care during the next few weeks for unforeseen non–COVID-related illnesses, such as a sudden heart attack or stroke, may be affected by the shortage of medical providers because of illness, quarantine, and burnout.
• There will be fewer first responders, including EMTs, police officers, and firefighters, because of COVID quarantines from illness and exposure.
• Although most Americans oppose temporary shutdowns, de facto shutdowns might be necessary because of the absence of healthy, COVID-negative individuals to maintain a functional society.
• Omicron math is deceiving, since the risk of hospitalization with Omicron appears to be far lower than with the Delta variant. However, the higher volume of infections with Omicron will offset the lower severity leading to comparable numbers of hospitalizations.
• Omicron has made it difficult for some schools to reopen after the holiday break, and reopening might become even more difficult as the surge progresses. Many schools already were in desperate need of substitute teachers, bus drivers, and additional staff necessary for COVID safety precautions before the emergence of the Omicron variant.
• And, for a less altruistic reason, as if the nine reasons above weren’t enough – if infections continue, especially among the unvaccinated – where the virus mutates the most – this can lead to a trifecta variant that not only evades the immune system and is highly infectious but causes severe disease in both the unvaccinated as well as the vaccinated.

Because of its extremely high transmissibility, the Omicron variant – layered atop Delta – presents great risk to us as a society. We must do all we can as clinicians to educate our patients so that they can protect themselves and their families.

Dr. Abraham is a psychiatrist in private practice in Philadelphia. She has no disclosures.

To reduce risks of lung cancer mortality, interventions designed to improve high-risk groups’ uptake of low-dose CT (LDCT) lung cancer screening should focus on perceptions of lung cancer controllability, survival, and perceived effectiveness of changes in behavior, according to analysis of data from the SUMMIT study recently published in the Journal of Thoracic Oncology. Such an approach may be more effective than trying to change risk perceptions.

While 1-year survival among patients diagnosed with early-stage lung cancer is 88%, it is only 19% for those diagnosed with advanced disease. But only 27% of patients are diagnosed with early-stage disease. Screening high-risk asymptomatic adults using LDCT detects early-stage disease and significantly reduces lung cancer mortality, according to Samantha L. Quaife, PhD, of the Wolfson Institute of Population Health at Queen Mary University of London, and associates.

The effectiveness and equity of LDCT lung cancer screening as a population-level early detection strategy is compromised by low uptake among high-risk groups, the authors wrote.

In the United States, only 2% of eligible smokers have been screened since screening was first recommended in 2013. To provide a scientific evidence base for intervention, an understanding of factors making high-risk groups less likely to participate in LDCT screening is critical, Dr. Quaife and colleagues wrote.

Their longitudinal cohort study evaluating psychological correlates of lung cancer screening uptake included 44,000 ever-smokers (aged 55-77 years) who were invited to mail a self-regulatory questionnaire for lung cancer screening. Eligibility for LDCT lung cancer screening and inclusion in the SUMMIT study were further determined through telephone and in-person Lung Health Check (LHC) appointments. The primary outcome was uptake of the invitation to book an LHC appointment by telephone.

Of those invited, 7,966 (18.1%) returned the questionnaire with 7,730 (45% female; mean age, about 64 years) linked to screening uptake data. About 30% reported being current smokers with high tobacco dependence (60.3% smoking within 30 minutes of waking). The analysis from Dr. Quaife and colleagues looked at psychological correlates of lung cancer screening uptake using a psychometrically validated self-regulatory questionnaire for lung cancer screening (SRQ-LCS) to measure psychological constructs hypothesized to be associated with uptake which included consequences, emotional representation, coherence (lung cancer knowledge), treatment control, personal control, risk perception, perceived stigma, response efficacy of smoking cessation, early diagnosis behavioral response, survival from lung cancer, and treatment intention.

Among those who perceived early diagnosis to be more beneficial as a behavioral response, the positive association with uptake was strongest (adjusted odds ratio, 1.37; 95% confidence interval, 1.33-1.41). Those who perceived greater personal control (aOR, 1.09; 95% CI, 1.05-1.11) or believed their risk of lung cancer was high (aOR, 1.08; 95% CI, 1.05-1.10) were also more likely to respond. Other uptake increases were found for those who perceived smoking cessation as an effective means of reducing lung cancer risk or thought the chances of surviving early-stage lung cancer were good or fair (P < .01), and for those who perceived lung cancer as stigmatized (aOR, 1.26; 95% CI, 1.14-1.40). Most of these constructs were also perceived more negatively by current than former smokers.

Income, employment, education, social class, and housing conditions were significantly associated with many of the constructs. Greater affluence correlated with perceived personal control and benefit from early diagnosis, but more negative perceptions of the consequences of lung cancer. Also, those from more affluent areas were more likely to perceive lung cancer to be stigmatized and perceive smoking cessation to be less effective in reducing risk. Current daily smokers were less willing to be treated for early-stage disease, more pessimistic about survival, but had the highest-risk perception scores, at odds with their lower participation in lung screening trials. This contradiction, Dr. Quaife and colleagues suggested, may be explained by current smokers also holding more negative perceptions associated with lower uptake, including negative perceptions of lung cancer controllability, early diagnosis and survival, lower willingness to be treated, and belief that smoking cessation is less effective in reducing risk. All of these undermine positive responses to their high perceived risk.

“These findings pinpoint specific psychological targets for intervention,” the authors wrote. Experimental studies investigating the methods and mechanisms through which these perceptions could be changed are needed.

The study was funded by Cancer Research UK Population Research Fellowship (C50664/A24460) awarded to Dr. Quaife. The study investigators declared no support from financial organizations that might have an interest in the submitted work in the previous 3 years.

To reduce risks of lung cancer mortality, interventions designed to improve high-risk groups’ uptake of low-dose CT (LDCT) lung cancer screening should focus on perceptions of lung cancer controllability, survival, and perceived effectiveness of changes in behavior, according to analysis of data from the SUMMIT study recently published in the Journal of Thoracic Oncology. Such an approach may be more effective than trying to change risk perceptions.

While 1-year survival among patients diagnosed with early-stage lung cancer is 88%, it is only 19% for those diagnosed with advanced disease. But only 27% of patients are diagnosed with early-stage disease. Screening high-risk asymptomatic adults using LDCT detects early-stage disease and significantly reduces lung cancer mortality, according to Samantha L. Quaife, PhD, of the Wolfson Institute of Population Health at Queen Mary University of London, and associates.

The effectiveness and equity of LDCT lung cancer screening as a population-level early detection strategy is compromised by low uptake among high-risk groups, the authors wrote.

In the United States, only 2% of eligible smokers have been screened since screening was first recommended in 2013. To provide a scientific evidence base for intervention, an understanding of factors making high-risk groups less likely to participate in LDCT screening is critical, Dr. Quaife and colleagues wrote.

Their longitudinal cohort study evaluating psychological correlates of lung cancer screening uptake included 44,000 ever-smokers (aged 55-77 years) who were invited to mail a self-regulatory questionnaire for lung cancer screening. Eligibility for LDCT lung cancer screening and inclusion in the SUMMIT study were further determined through telephone and in-person Lung Health Check (LHC) appointments. The primary outcome was uptake of the invitation to book an LHC appointment by telephone.

Of those invited, 7,966 (18.1%) returned the questionnaire with 7,730 (45% female; mean age, about 64 years) linked to screening uptake data. About 30% reported being current smokers with high tobacco dependence (60.3% smoking within 30 minutes of waking). The analysis from Dr. Quaife and colleagues looked at psychological correlates of lung cancer screening uptake using a psychometrically validated self-regulatory questionnaire for lung cancer screening (SRQ-LCS) to measure psychological constructs hypothesized to be associated with uptake which included consequences, emotional representation, coherence (lung cancer knowledge), treatment control, personal control, risk perception, perceived stigma, response efficacy of smoking cessation, early diagnosis behavioral response, survival from lung cancer, and treatment intention.

Among those who perceived early diagnosis to be more beneficial as a behavioral response, the positive association with uptake was strongest (adjusted odds ratio, 1.37; 95% confidence interval, 1.33-1.41). Those who perceived greater personal control (aOR, 1.09; 95% CI, 1.05-1.11) or believed their risk of lung cancer was high (aOR, 1.08; 95% CI, 1.05-1.10) were also more likely to respond. Other uptake increases were found for those who perceived smoking cessation as an effective means of reducing lung cancer risk or thought the chances of surviving early-stage lung cancer were good or fair (P < .01), and for those who perceived lung cancer as stigmatized (aOR, 1.26; 95% CI, 1.14-1.40). Most of these constructs were also perceived more negatively by current than former smokers.

Income, employment, education, social class, and housing conditions were significantly associated with many of the constructs. Greater affluence correlated with perceived personal control and benefit from early diagnosis, but more negative perceptions of the consequences of lung cancer. Also, those from more affluent areas were more likely to perceive lung cancer to be stigmatized and perceive smoking cessation to be less effective in reducing risk. Current daily smokers were less willing to be treated for early-stage disease, more pessimistic about survival, but had the highest-risk perception scores, at odds with their lower participation in lung screening trials. This contradiction, Dr. Quaife and colleagues suggested, may be explained by current smokers also holding more negative perceptions associated with lower uptake, including negative perceptions of lung cancer controllability, early diagnosis and survival, lower willingness to be treated, and belief that smoking cessation is less effective in reducing risk. All of these undermine positive responses to their high perceived risk.

“These findings pinpoint specific psychological targets for intervention,” the authors wrote. Experimental studies investigating the methods and mechanisms through which these perceptions could be changed are needed.

The study was funded by Cancer Research UK Population Research Fellowship (C50664/A24460) awarded to Dr. Quaife. The study investigators declared no support from financial organizations that might have an interest in the submitted work in the previous 3 years.

To reduce risks of lung cancer mortality, interventions designed to improve high-risk groups’ uptake of low-dose CT (LDCT) lung cancer screening should focus on perceptions of lung cancer controllability, survival, and perceived effectiveness of changes in behavior, according to analysis of data from the SUMMIT study recently published in the Journal of Thoracic Oncology. Such an approach may be more effective than trying to change risk perceptions.

While 1-year survival among patients diagnosed with early-stage lung cancer is 88%, it is only 19% for those diagnosed with advanced disease. But only 27% of patients are diagnosed with early-stage disease. Screening high-risk asymptomatic adults using LDCT detects early-stage disease and significantly reduces lung cancer mortality, according to Samantha L. Quaife, PhD, of the Wolfson Institute of Population Health at Queen Mary University of London, and associates.

The effectiveness and equity of LDCT lung cancer screening as a population-level early detection strategy is compromised by low uptake among high-risk groups, the authors wrote.

In the United States, only 2% of eligible smokers have been screened since screening was first recommended in 2013. To provide a scientific evidence base for intervention, an understanding of factors making high-risk groups less likely to participate in LDCT screening is critical, Dr. Quaife and colleagues wrote.

Their longitudinal cohort study evaluating psychological correlates of lung cancer screening uptake included 44,000 ever-smokers (aged 55-77 years) who were invited to mail a self-regulatory questionnaire for lung cancer screening. Eligibility for LDCT lung cancer screening and inclusion in the SUMMIT study were further determined through telephone and in-person Lung Health Check (LHC) appointments. The primary outcome was uptake of the invitation to book an LHC appointment by telephone.

Of those invited, 7,966 (18.1%) returned the questionnaire with 7,730 (45% female; mean age, about 64 years) linked to screening uptake data. About 30% reported being current smokers with high tobacco dependence (60.3% smoking within 30 minutes of waking). The analysis from Dr. Quaife and colleagues looked at psychological correlates of lung cancer screening uptake using a psychometrically validated self-regulatory questionnaire for lung cancer screening (SRQ-LCS) to measure psychological constructs hypothesized to be associated with uptake which included consequences, emotional representation, coherence (lung cancer knowledge), treatment control, personal control, risk perception, perceived stigma, response efficacy of smoking cessation, early diagnosis behavioral response, survival from lung cancer, and treatment intention.

Among those who perceived early diagnosis to be more beneficial as a behavioral response, the positive association with uptake was strongest (adjusted odds ratio, 1.37; 95% confidence interval, 1.33-1.41). Those who perceived greater personal control (aOR, 1.09; 95% CI, 1.05-1.11) or believed their risk of lung cancer was high (aOR, 1.08; 95% CI, 1.05-1.10) were also more likely to respond. Other uptake increases were found for those who perceived smoking cessation as an effective means of reducing lung cancer risk or thought the chances of surviving early-stage lung cancer were good or fair (P < .01), and for those who perceived lung cancer as stigmatized (aOR, 1.26; 95% CI, 1.14-1.40). Most of these constructs were also perceived more negatively by current than former smokers.

Income, employment, education, social class, and housing conditions were significantly associated with many of the constructs. Greater affluence correlated with perceived personal control and benefit from early diagnosis, but more negative perceptions of the consequences of lung cancer. Also, those from more affluent areas were more likely to perceive lung cancer to be stigmatized and perceive smoking cessation to be less effective in reducing risk. Current daily smokers were less willing to be treated for early-stage disease, more pessimistic about survival, but had the highest-risk perception scores, at odds with their lower participation in lung screening trials. This contradiction, Dr. Quaife and colleagues suggested, may be explained by current smokers also holding more negative perceptions associated with lower uptake, including negative perceptions of lung cancer controllability, early diagnosis and survival, lower willingness to be treated, and belief that smoking cessation is less effective in reducing risk. All of these undermine positive responses to their high perceived risk.

“These findings pinpoint specific psychological targets for intervention,” the authors wrote. Experimental studies investigating the methods and mechanisms through which these perceptions could be changed are needed.

The study was funded by Cancer Research UK Population Research Fellowship (C50664/A24460) awarded to Dr. Quaife. The study investigators declared no support from financial organizations that might have an interest in the submitted work in the previous 3 years.

Along with long-standing concerns about immunodeficiency and use of immunosuppressive medication in people with rheumatoid arthritis (RA) are juxtaposed concerns about their additional risk of COVID-19 during the pandemic. Several studies have reported a high risk of severe COVID-19 outcomes in people with rheumatic disease, though few have compared this risk to the general population. This cohort study by Wang et al.¹ examines the risk of COVID-19 in people with RA compared to people with OA and the general population based on an electronic medical record database in the UK. The rate of COVID-19 was higher among people with RA than the general population, with a hazard ratio of 1.42 for confirmed COVID-19 cases, while the rate among people with OA was not increased. This finding confirms suspicions, though, due to the study design, it does not lend additional insight into nuances given the lack of information about RA treatment and activity as in prior studies.

Also of concern in the midst of the pandemic is the effect of RA and its treatment on response to vaccines against SARS-CoV-2. The rapid development of mRNA vaccines has been a boon, but research on vaccine response in people with rheumatic disease has suggested that certain medications can impact antibody formation. Iancovici et al.² examined antibody and B cell responses after vaccination in people with RA being treated with Janus kinase (JAK)-inhibitors or tumor necrosis factor (TNF)-inhibitors and in healthy volunteers. Though the study is flawed as responses were not assessed at the same timepoint after vaccination in all subjects and limited due to the heterogeneity of treatment and small numbers of subjects, antibody production and other assays were decreased in RA subjects, suggesting reduced humoral immunity. Whether a pause in JAK inhibitor treatment, as recommended by the American College of Rheumatology, makes an appreciable difference in these assessments of vaccine response is as yet unknown. Further, given the limited data, it is unclear whether having RA on its own, rather than the treatments involved, was the causative factor. Research is already underway on SARS-CoV-2 vaccine response in people with RA and other rheumatic diseases, but studies such as these also imply a relative immunodeficiency due to the diseases and their treatment that could extend to other vaccines or infections.

In addition to impacts on SARS-CoV-2 vaccine response, treatment with JAK inhibitors is known to increase risk of herpes zoster (HZ). A post hoc analysis of pooled data from 21 RA and 3 psoriatic arthritis (PsA) tofacitinib trials by Winthrop et al.³ evaluated the number and severity of HZ infections. Interestingly, HZ infections occurred more frequently in participants in the RA clinical trials, with about 11% having an infection compared to 5% in the PsA studies, once again highlighting a potential immunodeficiency particular to people with RA. Most patients had mild to moderate infections, but a small proportion of patients (<5%) had severe infections. Given the possibility of a reduced vaccine response, though unknown, after HZ vaccination in people with RA, consideration should be given not only to vaccination prior to initiation of JAK inhibitor therapy, but to assessment of vaccine efficacy and the ideal dosing schedules in these patients.

References

1. Wang Y et al. Increased risk of COVID-19 in patients with rheumatoid arthritis: a general population-based cohort study. Arthritis Care Res (Hoboken) 2021(Dec 7). 
2. Iancovici L et al. Rheumatoid arthritis patients treated with Janus kinase inhibitors show reduced humoral immune responses following BNT162b2 vaccination. Rheumatology (Oxford). 2021:keab879 (Nov 25).
3. Winthrop KL et al. Clinical management of herpes zoster in patients with rheumatoid arthritis or psoriatic arthritis receiving tofacitinib treatment. Rheumatol Ther. 2021 (Dec 6).

Along with long-standing concerns about immunodeficiency and use of immunosuppressive medication in people with rheumatoid arthritis (RA) are juxtaposed concerns about their additional risk of COVID-19 during the pandemic. Several studies have reported a high risk of severe COVID-19 outcomes in people with rheumatic disease, though few have compared this risk to the general population. This cohort study by Wang et al.¹ examines the risk of COVID-19 in people with RA compared to people with OA and the general population based on an electronic medical record database in the UK. The rate of COVID-19 was higher among people with RA than the general population, with a hazard ratio of 1.42 for confirmed COVID-19 cases, while the rate among people with OA was not increased. This finding confirms suspicions, though, due to the study design, it does not lend additional insight into nuances given the lack of information about RA treatment and activity as in prior studies.

Also of concern in the midst of the pandemic is the effect of RA and its treatment on response to vaccines against SARS-CoV-2. The rapid development of mRNA vaccines has been a boon, but research on vaccine response in people with rheumatic disease has suggested that certain medications can impact antibody formation. Iancovici et al.² examined antibody and B cell responses after vaccination in people with RA being treated with Janus kinase (JAK)-inhibitors or tumor necrosis factor (TNF)-inhibitors and in healthy volunteers. Though the study is flawed as responses were not assessed at the same timepoint after vaccination in all subjects and limited due to the heterogeneity of treatment and small numbers of subjects, antibody production and other assays were decreased in RA subjects, suggesting reduced humoral immunity. Whether a pause in JAK inhibitor treatment, as recommended by the American College of Rheumatology, makes an appreciable difference in these assessments of vaccine response is as yet unknown. Further, given the limited data, it is unclear whether having RA on its own, rather than the treatments involved, was the causative factor. Research is already underway on SARS-CoV-2 vaccine response in people with RA and other rheumatic diseases, but studies such as these also imply a relative immunodeficiency due to the diseases and their treatment that could extend to other vaccines or infections.

In addition to impacts on SARS-CoV-2 vaccine response, treatment with JAK inhibitors is known to increase risk of herpes zoster (HZ). A post hoc analysis of pooled data from 21 RA and 3 psoriatic arthritis (PsA) tofacitinib trials by Winthrop et al.³ evaluated the number and severity of HZ infections. Interestingly, HZ infections occurred more frequently in participants in the RA clinical trials, with about 11% having an infection compared to 5% in the PsA studies, once again highlighting a potential immunodeficiency particular to people with RA. Most patients had mild to moderate infections, but a small proportion of patients (<5%) had severe infections. Given the possibility of a reduced vaccine response, though unknown, after HZ vaccination in people with RA, consideration should be given not only to vaccination prior to initiation of JAK inhibitor therapy, but to assessment of vaccine efficacy and the ideal dosing schedules in these patients.

References

1. Wang Y et al. Increased risk of COVID-19 in patients with rheumatoid arthritis: a general population-based cohort study. Arthritis Care Res (Hoboken) 2021(Dec 7). 
2. Iancovici L et al. Rheumatoid arthritis patients treated with Janus kinase inhibitors show reduced humoral immune responses following BNT162b2 vaccination. Rheumatology (Oxford). 2021:keab879 (Nov 25).
3. Winthrop KL et al. Clinical management of herpes zoster in patients with rheumatoid arthritis or psoriatic arthritis receiving tofacitinib treatment. Rheumatol Ther. 2021 (Dec 6).

Along with long-standing concerns about immunodeficiency and use of immunosuppressive medication in people with rheumatoid arthritis (RA) are juxtaposed concerns about their additional risk of COVID-19 during the pandemic. Several studies have reported a high risk of severe COVID-19 outcomes in people with rheumatic disease, though few have compared this risk to the general population. This cohort study by Wang et al.¹ examines the risk of COVID-19 in people with RA compared to people with OA and the general population based on an electronic medical record database in the UK. The rate of COVID-19 was higher among people with RA than the general population, with a hazard ratio of 1.42 for confirmed COVID-19 cases, while the rate among people with OA was not increased. This finding confirms suspicions, though, due to the study design, it does not lend additional insight into nuances given the lack of information about RA treatment and activity as in prior studies.

Also of concern in the midst of the pandemic is the effect of RA and its treatment on response to vaccines against SARS-CoV-2. The rapid development of mRNA vaccines has been a boon, but research on vaccine response in people with rheumatic disease has suggested that certain medications can impact antibody formation. Iancovici et al.² examined antibody and B cell responses after vaccination in people with RA being treated with Janus kinase (JAK)-inhibitors or tumor necrosis factor (TNF)-inhibitors and in healthy volunteers. Though the study is flawed as responses were not assessed at the same timepoint after vaccination in all subjects and limited due to the heterogeneity of treatment and small numbers of subjects, antibody production and other assays were decreased in RA subjects, suggesting reduced humoral immunity. Whether a pause in JAK inhibitor treatment, as recommended by the American College of Rheumatology, makes an appreciable difference in these assessments of vaccine response is as yet unknown. Further, given the limited data, it is unclear whether having RA on its own, rather than the treatments involved, was the causative factor. Research is already underway on SARS-CoV-2 vaccine response in people with RA and other rheumatic diseases, but studies such as these also imply a relative immunodeficiency due to the diseases and their treatment that could extend to other vaccines or infections.

In addition to impacts on SARS-CoV-2 vaccine response, treatment with JAK inhibitors is known to increase risk of herpes zoster (HZ). A post hoc analysis of pooled data from 21 RA and 3 psoriatic arthritis (PsA) tofacitinib trials by Winthrop et al.³ evaluated the number and severity of HZ infections. Interestingly, HZ infections occurred more frequently in participants in the RA clinical trials, with about 11% having an infection compared to 5% in the PsA studies, once again highlighting a potential immunodeficiency particular to people with RA. Most patients had mild to moderate infections, but a small proportion of patients (<5%) had severe infections. Given the possibility of a reduced vaccine response, though unknown, after HZ vaccination in people with RA, consideration should be given not only to vaccination prior to initiation of JAK inhibitor therapy, but to assessment of vaccine efficacy and the ideal dosing schedules in these patients.

References

1. Wang Y et al. Increased risk of COVID-19 in patients with rheumatoid arthritis: a general population-based cohort study. Arthritis Care Res (Hoboken) 2021(Dec 7). 
2. Iancovici L et al. Rheumatoid arthritis patients treated with Janus kinase inhibitors show reduced humoral immune responses following BNT162b2 vaccination. Rheumatology (Oxford). 2021:keab879 (Nov 25).
3. Winthrop KL et al. Clinical management of herpes zoster in patients with rheumatoid arthritis or psoriatic arthritis receiving tofacitinib treatment. Rheumatol Ther. 2021 (Dec 6).