TOPLINE:

Although practice patterns vary widely, modified, reduced-dose FOLFIRINOX is as effective as standard, full-dose regimens for patients with metastatic pancreatic cancer in the first-line setting, and it is less likely to cause febrile neutropenia.

METHODOLOGY:

• No randomized controlled trials have directly compared modified FOLFIRINOX to standard FOLFIRINOX; this meta-analysis aims to fill the evidence gap.
• The investigators winnowed hundreds of first-line FOLFIRINOX studies down to 37 – 11 prospective and 26 retrospective analyses – to assess practice patterns and clinical outcomes.
• Dose information was grouped into four categories: planned dose in the standard FOLFIRINOX group; actual administered dose in the standard group; planned dose in the modified group; actual administered dose in the modified group.

TAKEAWAY:

• There were 12 types of “planned” dose reductions in FOLFIRINOX: 75%-100% oxaliplatin, 75%-100% irinotecan, 0%-100% 5-fluorouracil (5-FU) bolus, and 75%-133% 5-FU continuous injection.
• Doses actually delivered fell further to 54%-96% for oxaliplatin, 61%-88% for irinotecan, 0%-92% for 5-FU bolus, and 63%-98% 5-FU continuous injection.
• Despite the variations in dosing, reduced doses of FOLFIRINOX were associated with a slightly but not significantly higher objective response rate: 33.8% versus 28.2% for standard dosing (P = .1).
• The incidence of febrile neutropenia was significantly lower in the reduced-dose groups: 5.5% with modified FOLFIRINOX versus 11.6% with standard (P = .03).

IN PRACTICE:

Although the study supports reduced-dose regimens, it also shows that there is “still no consensus” on appropriate dose modification, the authors said. “The best dose modification protocol” remains to be determined and standardized for metastatic pancreatic cancer.

SOURCE:

The study was led by Kwangrok Jung at Seoul (South Korea) National University, and was published June 29 in Therapeutic Advances in Medical Oncology.

LIMITATIONS:

• Only 11 of the 37 studies were prospective.
• The studies often lacked key information, including the reason for dose reductions or detailed dose reduction protocols.
• Studies were also inconsistent in how they reported FOLFIRINOX dose modifications.

DISCLOSURES:

There was no funding for the study, and the investigators had no disclosures.

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

TOPLINE:

Although practice patterns vary widely, modified, reduced-dose FOLFIRINOX is as effective as standard, full-dose regimens for patients with metastatic pancreatic cancer in the first-line setting, and it is less likely to cause febrile neutropenia.

METHODOLOGY:

• No randomized controlled trials have directly compared modified FOLFIRINOX to standard FOLFIRINOX; this meta-analysis aims to fill the evidence gap.
• The investigators winnowed hundreds of first-line FOLFIRINOX studies down to 37 – 11 prospective and 26 retrospective analyses – to assess practice patterns and clinical outcomes.
• Dose information was grouped into four categories: planned dose in the standard FOLFIRINOX group; actual administered dose in the standard group; planned dose in the modified group; actual administered dose in the modified group.

TAKEAWAY:

• There were 12 types of “planned” dose reductions in FOLFIRINOX: 75%-100% oxaliplatin, 75%-100% irinotecan, 0%-100% 5-fluorouracil (5-FU) bolus, and 75%-133% 5-FU continuous injection.
• Doses actually delivered fell further to 54%-96% for oxaliplatin, 61%-88% for irinotecan, 0%-92% for 5-FU bolus, and 63%-98% 5-FU continuous injection.
• Despite the variations in dosing, reduced doses of FOLFIRINOX were associated with a slightly but not significantly higher objective response rate: 33.8% versus 28.2% for standard dosing (P = .1).
• The incidence of febrile neutropenia was significantly lower in the reduced-dose groups: 5.5% with modified FOLFIRINOX versus 11.6% with standard (P = .03).

IN PRACTICE:

Although the study supports reduced-dose regimens, it also shows that there is “still no consensus” on appropriate dose modification, the authors said. “The best dose modification protocol” remains to be determined and standardized for metastatic pancreatic cancer.

SOURCE:

The study was led by Kwangrok Jung at Seoul (South Korea) National University, and was published June 29 in Therapeutic Advances in Medical Oncology.

LIMITATIONS:

• Only 11 of the 37 studies were prospective.
• The studies often lacked key information, including the reason for dose reductions or detailed dose reduction protocols.
• Studies were also inconsistent in how they reported FOLFIRINOX dose modifications.

DISCLOSURES:

There was no funding for the study, and the investigators had no disclosures.

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

TOPLINE:

Although practice patterns vary widely, modified, reduced-dose FOLFIRINOX is as effective as standard, full-dose regimens for patients with metastatic pancreatic cancer in the first-line setting, and it is less likely to cause febrile neutropenia.

METHODOLOGY:

• No randomized controlled trials have directly compared modified FOLFIRINOX to standard FOLFIRINOX; this meta-analysis aims to fill the evidence gap.
• The investigators winnowed hundreds of first-line FOLFIRINOX studies down to 37 – 11 prospective and 26 retrospective analyses – to assess practice patterns and clinical outcomes.
• Dose information was grouped into four categories: planned dose in the standard FOLFIRINOX group; actual administered dose in the standard group; planned dose in the modified group; actual administered dose in the modified group.

TAKEAWAY:

• There were 12 types of “planned” dose reductions in FOLFIRINOX: 75%-100% oxaliplatin, 75%-100% irinotecan, 0%-100% 5-fluorouracil (5-FU) bolus, and 75%-133% 5-FU continuous injection.
• Doses actually delivered fell further to 54%-96% for oxaliplatin, 61%-88% for irinotecan, 0%-92% for 5-FU bolus, and 63%-98% 5-FU continuous injection.
• Despite the variations in dosing, reduced doses of FOLFIRINOX were associated with a slightly but not significantly higher objective response rate: 33.8% versus 28.2% for standard dosing (P = .1).
• The incidence of febrile neutropenia was significantly lower in the reduced-dose groups: 5.5% with modified FOLFIRINOX versus 11.6% with standard (P = .03).

IN PRACTICE:

Although the study supports reduced-dose regimens, it also shows that there is “still no consensus” on appropriate dose modification, the authors said. “The best dose modification protocol” remains to be determined and standardized for metastatic pancreatic cancer.

SOURCE:

The study was led by Kwangrok Jung at Seoul (South Korea) National University, and was published June 29 in Therapeutic Advances in Medical Oncology.

LIMITATIONS:

• Only 11 of the 37 studies were prospective.
• The studies often lacked key information, including the reason for dose reductions or detailed dose reduction protocols.
• Studies were also inconsistent in how they reported FOLFIRINOX dose modifications.

DISCLOSURES:

There was no funding for the study, and the investigators had no disclosures.

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

To the Editor:

Porocarcinoma, or malignant poroma, is a rare adnexal malignancy of a predominantly glandular origin that comprises less than 0.01% of all cutaneous neoplasms.^1,2 Although exposure to UV radiation and immunosuppression have been implicated in the malignant degeneration of benign poromas into porocarcinomas, at least half of all malignant variants will arise de novo.^3,4 Patients present with an evolving nodule or plaque and often are in their seventh or eighth decade of life at the time of diagnosis.² Localized trauma from burns or radiation exposure has been causatively linked to de novo porocarcinoma formation.^2,5 These suppressive and traumatic stimuli drive increased genetic heterogeneity along with characteristic gene mutations in known tumor suppressor genes.⁶

A 62-year-old man presented with a nonhealing wound on the right hand of 5 years’ duration that had previously been attributed to a penetrating injury with a piece of copper from a refrigerant coolant system. The wound initially blistered and then eventually callused and developed areas of ulceration. The patient consulted multiple physicians for treatment of the intensely pruritic and ulcerated lesion. He received prescriptions for cephalexin, trimethoprim-sulfamethoxazole, doxycycline, clindamycin, and clobetasol cream, all of which offered minimal improvement. Home therapies including vitamin E and tea tree oil yielded no benefit. The lesion roughly quadrupled in size over the last 5 years.

Physical examination revealed a 7.5×4.2-cm ulcerated plaque with ragged borders and abundant central neoepithelialization on the right palmar surface (Figure 1). No gross motor or sensory defects were identified. There was no epitrochlear, axillary, cervical, or supraclavicular lymphadenopathy. A shave biopsy of the plaque’s edge was performed, which demonstrated a hyperplastic epidermis comprising atypical poroid cells with frequent mitoses, scant necrosis, and regular ductal structures confined to the epidermis (Figure 2). Immunohistochemical profiling results were positive for anticytokeratin (CAM 5.2) and Ber-EP4 (Figure 3). When evaluated in aggregate, these findings were consistent with porocarcinoma in situ.

The patient was referred to a surgical oncologist for evaluation. At that time, an exophytic mass had developed in the central lesion. Although no lymphadenopathy was identified upon examination, the patient had developed tremoring and a contracture deformity of the right hand. Extensive imaging and urgent surgical resection were recommended, but the patient did not wish to pursue these options, opting instead to continue home remedies. At a 15-month follow-up via telephone, the patient reported that the home therapy had failed and he had moved back to Vietnam. Partial limb amputation had been recommended by a local provider. Unfortunately, the patient was subsequently lost to follow-up, and his current status is unknown.

Porocarcinomas are rare tumors, comprising just 0.005% to 0.01% of all cutaneous epithelial tumors.^1,2,5 They affect men and women equally, with an average age at diagnosis of 60 to 70 years.^1,2 At least half of all porocarcinomas develop de novo, while 18% to 50% arise from the degeneration of an existing poroma.^2,3 Exposure to UV light and immunosuppression, particularly following organ transplantation, represent 2 commonly suspected catalysts for this malignant transformation.⁴ De novo porocarcinomas are most causatively linked to localized trauma from burns or radiation exposure.⁵ Gene mutations in classic tumor suppressor genes—tumor protein p53 (TP53), phosphatase and tensin homolog (PTEN), rearranged during transfection (RET), adenomatous polyposis coli (APC)—and increased genetic heterogeneity follow these stimuli.⁶

The morphologic presentation of porocarcinoma is highly variable and may manifest as papules, nodules, or plaques in various states of erosion, ulceration, or excoriation. Diagnoses of basal and squamous cell carcinoma, primary adnexal tumors, seborrheic keratosis, pyogenic granuloma, and melanoma must all be considered and methodically ruled out.⁷ Porocarcinomas may arise nearly anywhere on the body, with a particular predilection for the lower extremities (35%), head/neck (24%), and upper extremities (14%).^3,4 Primary lesions arising from the extremities, genitalia, or buttocks herald a higher risk for lymphatic invasion and distant metastasis, while head and neck tumors more commonly remain localized.⁸ Bleeding, ulceration, or rapid expansion of a preexisting poroma is suggestive of malignant transformation and may portend a more aggressive disease pattern.^2,9

Unequivocal diagnosis relies on histological and immunohistochemical studies due to the marked clinical variance of this neoplasm.⁷ An irregular histologic pattern of poromatous basaloid cells with ductal differentiation and cytologic atypia commonly are seen with porocarcinomas.^2,8 Nuclear pleomorphism with cellular necrosis, increased mitotic figures, and abortive ductal formation with a distinct lack of retraction around cellular aggregates often are found. Immunohistochemical staining is needed to confirm the primary tumor diagnosis. Histochemical stains commonly employed include carcinoembryonic antigen (CEA), cytokeratin AE1/AE3, epithelial membrane antigen, p53, p63, Ki67, and periodic acid-Schiff.¹⁰ The use of BerEP4 has been reported as efficacious in highlighting sweat structures, which can be particularly useful in cases when basal cell carcinoma is not in the histologic differential.¹¹ These staining profiles afford confirmation of ductal differentiation with CEA, epithelial membrane antigen, and BerEP4, while p63 and Ki67 are used as surrogates for primary cutaneous neoplasia and cell proliferation, respectively.^5,11 Porocarcinoma lesions may be most sensitive to CEA and most specific to CK19 (a component of cytokeratin AE1/AE3), though these findings have not been widely reproduced.⁷

The treatment and prognosis of porocarcinoma vary widely. Surgically excised lesions recur in roughly 20% of cases, though these rates likely include tumors that were incompletely resected in the primary attempt. Although wide local excision with an average 1-cm margin remains the most employed removal technique, Mohs micrographic surgery may more effectively limit recurrence and metastasis of localized disease.^7,8,12 Metastatic disease foretells a mortality rate of at least 65%, which is problematic in that 10% to 20% of patients have metastatic disease at the time of diagnosis and another 20% will show metastasis following primary tumor excision.^8,10 Neoplasms with high mitotic rates and depths greater than 7 mm should prompt thorough diagnostic imaging, such as positron emission tomography or magnetic resonance imaging. A sentinel lymph node biopsy should be strongly considered and discussed with the patient.¹⁰ Treatment options for nodal and distant metastases include a combination of localized surgery, lymphadenectomy, radiotherapy, and chemotherapeutic agents.^2,4,5 The response to systemic treatment and radiotherapy often is quite poor, though the use of combinations of docetaxel, paclitaxel, cetuximab, and immunotherapy have been efficacious in smaller studies.^8,10 The highest rates of morbidity and mortality are seen in patients with metastases on presentation or with localized tumors in the groin and buttocks.⁸

The diagnosis of porocarcinoma may be elusive due to its relatively rare occurrence. Therefore, it is critical to consider this neoplasm in high-risk sites in older patients who present with an evolving nodule or tumor on an extremity. Routine histology and astute histochemical profiling are necessary to exclude diseases that mimic porocarcinoma. Once diagnosis is confirmed, management with prompt excision and diagnostic imaging is recommended, including a lymph node biopsy if appropriate. Due to its high metastatic potential and associated morbidity and mortality, patients with porocarcinoma should be followed closely by a multidisciplinary care team.

To the Editor:

Porocarcinoma, or malignant poroma, is a rare adnexal malignancy of a predominantly glandular origin that comprises less than 0.01% of all cutaneous neoplasms.^1,2 Although exposure to UV radiation and immunosuppression have been implicated in the malignant degeneration of benign poromas into porocarcinomas, at least half of all malignant variants will arise de novo.^3,4 Patients present with an evolving nodule or plaque and often are in their seventh or eighth decade of life at the time of diagnosis.² Localized trauma from burns or radiation exposure has been causatively linked to de novo porocarcinoma formation.^2,5 These suppressive and traumatic stimuli drive increased genetic heterogeneity along with characteristic gene mutations in known tumor suppressor genes.⁶

A 62-year-old man presented with a nonhealing wound on the right hand of 5 years’ duration that had previously been attributed to a penetrating injury with a piece of copper from a refrigerant coolant system. The wound initially blistered and then eventually callused and developed areas of ulceration. The patient consulted multiple physicians for treatment of the intensely pruritic and ulcerated lesion. He received prescriptions for cephalexin, trimethoprim-sulfamethoxazole, doxycycline, clindamycin, and clobetasol cream, all of which offered minimal improvement. Home therapies including vitamin E and tea tree oil yielded no benefit. The lesion roughly quadrupled in size over the last 5 years.

Physical examination revealed a 7.5×4.2-cm ulcerated plaque with ragged borders and abundant central neoepithelialization on the right palmar surface (Figure 1). No gross motor or sensory defects were identified. There was no epitrochlear, axillary, cervical, or supraclavicular lymphadenopathy. A shave biopsy of the plaque’s edge was performed, which demonstrated a hyperplastic epidermis comprising atypical poroid cells with frequent mitoses, scant necrosis, and regular ductal structures confined to the epidermis (Figure 2). Immunohistochemical profiling results were positive for anticytokeratin (CAM 5.2) and Ber-EP4 (Figure 3). When evaluated in aggregate, these findings were consistent with porocarcinoma in situ.

The patient was referred to a surgical oncologist for evaluation. At that time, an exophytic mass had developed in the central lesion. Although no lymphadenopathy was identified upon examination, the patient had developed tremoring and a contracture deformity of the right hand. Extensive imaging and urgent surgical resection were recommended, but the patient did not wish to pursue these options, opting instead to continue home remedies. At a 15-month follow-up via telephone, the patient reported that the home therapy had failed and he had moved back to Vietnam. Partial limb amputation had been recommended by a local provider. Unfortunately, the patient was subsequently lost to follow-up, and his current status is unknown.

Porocarcinomas are rare tumors, comprising just 0.005% to 0.01% of all cutaneous epithelial tumors.^1,2,5 They affect men and women equally, with an average age at diagnosis of 60 to 70 years.^1,2 At least half of all porocarcinomas develop de novo, while 18% to 50% arise from the degeneration of an existing poroma.^2,3 Exposure to UV light and immunosuppression, particularly following organ transplantation, represent 2 commonly suspected catalysts for this malignant transformation.⁴ De novo porocarcinomas are most causatively linked to localized trauma from burns or radiation exposure.⁵ Gene mutations in classic tumor suppressor genes—tumor protein p53 (TP53), phosphatase and tensin homolog (PTEN), rearranged during transfection (RET), adenomatous polyposis coli (APC)—and increased genetic heterogeneity follow these stimuli.⁶

The morphologic presentation of porocarcinoma is highly variable and may manifest as papules, nodules, or plaques in various states of erosion, ulceration, or excoriation. Diagnoses of basal and squamous cell carcinoma, primary adnexal tumors, seborrheic keratosis, pyogenic granuloma, and melanoma must all be considered and methodically ruled out.⁷ Porocarcinomas may arise nearly anywhere on the body, with a particular predilection for the lower extremities (35%), head/neck (24%), and upper extremities (14%).^3,4 Primary lesions arising from the extremities, genitalia, or buttocks herald a higher risk for lymphatic invasion and distant metastasis, while head and neck tumors more commonly remain localized.⁸ Bleeding, ulceration, or rapid expansion of a preexisting poroma is suggestive of malignant transformation and may portend a more aggressive disease pattern.^2,9

Unequivocal diagnosis relies on histological and immunohistochemical studies due to the marked clinical variance of this neoplasm.⁷ An irregular histologic pattern of poromatous basaloid cells with ductal differentiation and cytologic atypia commonly are seen with porocarcinomas.^2,8 Nuclear pleomorphism with cellular necrosis, increased mitotic figures, and abortive ductal formation with a distinct lack of retraction around cellular aggregates often are found. Immunohistochemical staining is needed to confirm the primary tumor diagnosis. Histochemical stains commonly employed include carcinoembryonic antigen (CEA), cytokeratin AE1/AE3, epithelial membrane antigen, p53, p63, Ki67, and periodic acid-Schiff.¹⁰ The use of BerEP4 has been reported as efficacious in highlighting sweat structures, which can be particularly useful in cases when basal cell carcinoma is not in the histologic differential.¹¹ These staining profiles afford confirmation of ductal differentiation with CEA, epithelial membrane antigen, and BerEP4, while p63 and Ki67 are used as surrogates for primary cutaneous neoplasia and cell proliferation, respectively.^5,11 Porocarcinoma lesions may be most sensitive to CEA and most specific to CK19 (a component of cytokeratin AE1/AE3), though these findings have not been widely reproduced.⁷

The treatment and prognosis of porocarcinoma vary widely. Surgically excised lesions recur in roughly 20% of cases, though these rates likely include tumors that were incompletely resected in the primary attempt. Although wide local excision with an average 1-cm margin remains the most employed removal technique, Mohs micrographic surgery may more effectively limit recurrence and metastasis of localized disease.^7,8,12 Metastatic disease foretells a mortality rate of at least 65%, which is problematic in that 10% to 20% of patients have metastatic disease at the time of diagnosis and another 20% will show metastasis following primary tumor excision.^8,10 Neoplasms with high mitotic rates and depths greater than 7 mm should prompt thorough diagnostic imaging, such as positron emission tomography or magnetic resonance imaging. A sentinel lymph node biopsy should be strongly considered and discussed with the patient.¹⁰ Treatment options for nodal and distant metastases include a combination of localized surgery, lymphadenectomy, radiotherapy, and chemotherapeutic agents.^2,4,5 The response to systemic treatment and radiotherapy often is quite poor, though the use of combinations of docetaxel, paclitaxel, cetuximab, and immunotherapy have been efficacious in smaller studies.^8,10 The highest rates of morbidity and mortality are seen in patients with metastases on presentation or with localized tumors in the groin and buttocks.⁸

The diagnosis of porocarcinoma may be elusive due to its relatively rare occurrence. Therefore, it is critical to consider this neoplasm in high-risk sites in older patients who present with an evolving nodule or tumor on an extremity. Routine histology and astute histochemical profiling are necessary to exclude diseases that mimic porocarcinoma. Once diagnosis is confirmed, management with prompt excision and diagnostic imaging is recommended, including a lymph node biopsy if appropriate. Due to its high metastatic potential and associated morbidity and mortality, patients with porocarcinoma should be followed closely by a multidisciplinary care team.

To the Editor:

Porocarcinoma, or malignant poroma, is a rare adnexal malignancy of a predominantly glandular origin that comprises less than 0.01% of all cutaneous neoplasms.^1,2 Although exposure to UV radiation and immunosuppression have been implicated in the malignant degeneration of benign poromas into porocarcinomas, at least half of all malignant variants will arise de novo.^3,4 Patients present with an evolving nodule or plaque and often are in their seventh or eighth decade of life at the time of diagnosis.² Localized trauma from burns or radiation exposure has been causatively linked to de novo porocarcinoma formation.^2,5 These suppressive and traumatic stimuli drive increased genetic heterogeneity along with characteristic gene mutations in known tumor suppressor genes.⁶

A 62-year-old man presented with a nonhealing wound on the right hand of 5 years’ duration that had previously been attributed to a penetrating injury with a piece of copper from a refrigerant coolant system. The wound initially blistered and then eventually callused and developed areas of ulceration. The patient consulted multiple physicians for treatment of the intensely pruritic and ulcerated lesion. He received prescriptions for cephalexin, trimethoprim-sulfamethoxazole, doxycycline, clindamycin, and clobetasol cream, all of which offered minimal improvement. Home therapies including vitamin E and tea tree oil yielded no benefit. The lesion roughly quadrupled in size over the last 5 years.

Physical examination revealed a 7.5×4.2-cm ulcerated plaque with ragged borders and abundant central neoepithelialization on the right palmar surface (Figure 1). No gross motor or sensory defects were identified. There was no epitrochlear, axillary, cervical, or supraclavicular lymphadenopathy. A shave biopsy of the plaque’s edge was performed, which demonstrated a hyperplastic epidermis comprising atypical poroid cells with frequent mitoses, scant necrosis, and regular ductal structures confined to the epidermis (Figure 2). Immunohistochemical profiling results were positive for anticytokeratin (CAM 5.2) and Ber-EP4 (Figure 3). When evaluated in aggregate, these findings were consistent with porocarcinoma in situ.

The patient was referred to a surgical oncologist for evaluation. At that time, an exophytic mass had developed in the central lesion. Although no lymphadenopathy was identified upon examination, the patient had developed tremoring and a contracture deformity of the right hand. Extensive imaging and urgent surgical resection were recommended, but the patient did not wish to pursue these options, opting instead to continue home remedies. At a 15-month follow-up via telephone, the patient reported that the home therapy had failed and he had moved back to Vietnam. Partial limb amputation had been recommended by a local provider. Unfortunately, the patient was subsequently lost to follow-up, and his current status is unknown.

Porocarcinomas are rare tumors, comprising just 0.005% to 0.01% of all cutaneous epithelial tumors.^1,2,5 They affect men and women equally, with an average age at diagnosis of 60 to 70 years.^1,2 At least half of all porocarcinomas develop de novo, while 18% to 50% arise from the degeneration of an existing poroma.^2,3 Exposure to UV light and immunosuppression, particularly following organ transplantation, represent 2 commonly suspected catalysts for this malignant transformation.⁴ De novo porocarcinomas are most causatively linked to localized trauma from burns or radiation exposure.⁵ Gene mutations in classic tumor suppressor genes—tumor protein p53 (TP53), phosphatase and tensin homolog (PTEN), rearranged during transfection (RET), adenomatous polyposis coli (APC)—and increased genetic heterogeneity follow these stimuli.⁶

The morphologic presentation of porocarcinoma is highly variable and may manifest as papules, nodules, or plaques in various states of erosion, ulceration, or excoriation. Diagnoses of basal and squamous cell carcinoma, primary adnexal tumors, seborrheic keratosis, pyogenic granuloma, and melanoma must all be considered and methodically ruled out.⁷ Porocarcinomas may arise nearly anywhere on the body, with a particular predilection for the lower extremities (35%), head/neck (24%), and upper extremities (14%).^3,4 Primary lesions arising from the extremities, genitalia, or buttocks herald a higher risk for lymphatic invasion and distant metastasis, while head and neck tumors more commonly remain localized.⁸ Bleeding, ulceration, or rapid expansion of a preexisting poroma is suggestive of malignant transformation and may portend a more aggressive disease pattern.^2,9

Unequivocal diagnosis relies on histological and immunohistochemical studies due to the marked clinical variance of this neoplasm.⁷ An irregular histologic pattern of poromatous basaloid cells with ductal differentiation and cytologic atypia commonly are seen with porocarcinomas.^2,8 Nuclear pleomorphism with cellular necrosis, increased mitotic figures, and abortive ductal formation with a distinct lack of retraction around cellular aggregates often are found. Immunohistochemical staining is needed to confirm the primary tumor diagnosis. Histochemical stains commonly employed include carcinoembryonic antigen (CEA), cytokeratin AE1/AE3, epithelial membrane antigen, p53, p63, Ki67, and periodic acid-Schiff.¹⁰ The use of BerEP4 has been reported as efficacious in highlighting sweat structures, which can be particularly useful in cases when basal cell carcinoma is not in the histologic differential.¹¹ These staining profiles afford confirmation of ductal differentiation with CEA, epithelial membrane antigen, and BerEP4, while p63 and Ki67 are used as surrogates for primary cutaneous neoplasia and cell proliferation, respectively.^5,11 Porocarcinoma lesions may be most sensitive to CEA and most specific to CK19 (a component of cytokeratin AE1/AE3), though these findings have not been widely reproduced.⁷

The treatment and prognosis of porocarcinoma vary widely. Surgically excised lesions recur in roughly 20% of cases, though these rates likely include tumors that were incompletely resected in the primary attempt. Although wide local excision with an average 1-cm margin remains the most employed removal technique, Mohs micrographic surgery may more effectively limit recurrence and metastasis of localized disease.^7,8,12 Metastatic disease foretells a mortality rate of at least 65%, which is problematic in that 10% to 20% of patients have metastatic disease at the time of diagnosis and another 20% will show metastasis following primary tumor excision.^8,10 Neoplasms with high mitotic rates and depths greater than 7 mm should prompt thorough diagnostic imaging, such as positron emission tomography or magnetic resonance imaging. A sentinel lymph node biopsy should be strongly considered and discussed with the patient.¹⁰ Treatment options for nodal and distant metastases include a combination of localized surgery, lymphadenectomy, radiotherapy, and chemotherapeutic agents.^2,4,5 The response to systemic treatment and radiotherapy often is quite poor, though the use of combinations of docetaxel, paclitaxel, cetuximab, and immunotherapy have been efficacious in smaller studies.^8,10 The highest rates of morbidity and mortality are seen in patients with metastases on presentation or with localized tumors in the groin and buttocks.⁸

The diagnosis of porocarcinoma may be elusive due to its relatively rare occurrence. Therefore, it is critical to consider this neoplasm in high-risk sites in older patients who present with an evolving nodule or tumor on an extremity. Routine histology and astute histochemical profiling are necessary to exclude diseases that mimic porocarcinoma. Once diagnosis is confirmed, management with prompt excision and diagnostic imaging is recommended, including a lymph node biopsy if appropriate. Due to its high metastatic potential and associated morbidity and mortality, patients with porocarcinoma should be followed closely by a multidisciplinary care team.

Brain disorders, including mental illness, neurologic conditions, and stroke, account for more than 15% of all health loss worldwide – more than either cardiovascular disease or cancer – at huge cost to health care systems and society, an analysis of data from the most recent Global Burden of Disease (GBD) study shows.

“The burden of brain conditions will increase as populations continue to grow and age,” said study presenter Shayla Smith, MPH, an epidemiologist at the Institute for Health Metrics and Evaluation, the University of Washington, Seattle, in a press release.

“By 2050, more than 50 million people will be aged 65-79,” she explained, adding that the COVID-19 pandemic “has also influenced the prevalence of mental disorders globally, as people were forced to isolate and social networks broke down.”

Other factors related to brain disorders, she noted, include education level, obesity, and smoking.

“There’s still research to be done on what is the most effective way to maintain brain health, but some literature suggests a healthy brain can be achieved through a healthy lifestyle of managing conditions such as high blood pressure and diabetes, limiting alcohol consumption and smoking, prioritizing sleep, eating healthy, and staying physically and mentally active,” said Ms. Smith.

The findings were presented at the annual meeting of the Congress of the European Academy of Neurology.
 

An ‘ambitious exercise’

Coinvestigator Xaviera Steele, also from the IHME, told press conference attendees that the institute was established at the University of Washington in 2007 with the aim of “standardizing the measurement of health outcomes around the world and for all health conditions.”

A central part of that is the GBD study, “which is a very ambitious exercise in descriptive epidemiology in an effort to systematically quantify health loss” due to disease, injury, and risk factors over time, stratified by country, region, age, and sex. In addition, researchers are mapping and projecting trends over the next century and are estimating disease expenditure by country, by type of expense, and by condition “to derive a health care access and quality score for each health system in the world,” Ms. Steele said.

They are also estimating exposure to risk factors, how those risk factors contribute to health burden, and associated health outcomes by race and ethnicity to reflect the “disparities that we know are very prevalent in countries such as the United States.” From that work, Ms. Steele said that brain health and related conditions “do emerge as one of the more pressing challenges of the 21st century.”
 

Increase in dementia, mental health conditions

The data, which were gathered from 200,000 sources by the IHME, indicate that the number of individuals aged 65 years or older will increase by 350% by 2100. Ms. Steele underlined that “policy action will be needed to help families, who will struggle to provide high-quality care for their loved ones with dementia at a reasonable cost.”

The IHME calculates that in Europe health care spending on Alzheimer’s disease will increase by 226% between 2015 and 2040.

Turning to other conditions, Ms. Steele showed that since 1990, the number of individuals living with anxiety in the European region has increased by 14%, while the number living with depressive disorders has gone up by 13%.

Worldwide, the figures are even starker. Depression is estimated to affect 300 million people across the globe, which represents a 71% increase since 1990. The number of strokes increased by 95% over the same period.

Nevertheless, the “impact of brain conditions such as stroke has decreased since the 1990s due to improved treatments available,” Ms. Smith noted in the press release.

To estimate the toll caused by brain conditions, including neurologic disorders, mental disorders, cerebrovascular disease, brain cancer, brain injuries, and select infectious conditions, the researchers calculated disability-adjusted life years (DALYs).

This, Ms. Smith explained in her presentation, “captures the morbidity and mortality associated with brain conditions” and is adjusted for patient location, age, and sex.

The investigators found that, globally, brain conditions accounted for more than 15% of all health loss in 2021, at 406 DALYs – more than the 206 million DALYs that were associated with cancer, and the 402 million that were linked to cardiovascular disease.

This health loss is associated with a $1.22 trillion loss in income for people living with health disorders worldwide and accounts for $1.14 trillion in direct health care costs.

The burden of mental disorders, neurologic conditions, and stroke is expected to increase dramatically between now and 2050, said Ms. Smith, who noted that health loss linked to brain conditions is higher in younger patients. This will create “new challenges for health systems, employers, patients, and families,” she said in the press release.

“Our goal is to see an improved prevention and treatment landscape for other brain conditions and reverse the growing health loss that we are currently forecasting.”
 

Worrying increase in stroke

Jurgita Valaikiene, MD, PhD, center of neurology, clinic of neurology and neurosurgery, Vilnius (Lithuania) University Faculty of Medicine, who chaired the session, was taken aback by the findings, particularly by the worldwide increase in stroke cases.

“I work in stroke,” she said, and “we spend a lot of time on the diagnosis of stroke” and its prevention. “We try to be faster, to catch asymptomatic stenosis in the neck or head, and to apply the best medical treatment to avoid a stroke. But despite that, the numbers are increasing. I understand the population is getting older ... but still it’s a huge number.”

Dr. Valaikiene pointed out that stroke is not necessarily a condition of aging, insofar as increasing age “is not related directly to stenosis in the neck. “For example, we can have healthier vessels in older age and unhealthy vessels, with high-grade stenosis, in someone aged 30 or 40 years.”

“There are a lot of risk factors, such as smoking, physical activity, and so on. It depends on the individual,” she added.

The study was funded by the Institute for Health Metrics and Evaluation at the University of Washington. The authors have disclosed no relevant financial relationships.

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

Brain disorders, including mental illness, neurologic conditions, and stroke, account for more than 15% of all health loss worldwide – more than either cardiovascular disease or cancer – at huge cost to health care systems and society, an analysis of data from the most recent Global Burden of Disease (GBD) study shows.

“The burden of brain conditions will increase as populations continue to grow and age,” said study presenter Shayla Smith, MPH, an epidemiologist at the Institute for Health Metrics and Evaluation, the University of Washington, Seattle, in a press release.

“By 2050, more than 50 million people will be aged 65-79,” she explained, adding that the COVID-19 pandemic “has also influenced the prevalence of mental disorders globally, as people were forced to isolate and social networks broke down.”

Other factors related to brain disorders, she noted, include education level, obesity, and smoking.

“There’s still research to be done on what is the most effective way to maintain brain health, but some literature suggests a healthy brain can be achieved through a healthy lifestyle of managing conditions such as high blood pressure and diabetes, limiting alcohol consumption and smoking, prioritizing sleep, eating healthy, and staying physically and mentally active,” said Ms. Smith.

The findings were presented at the annual meeting of the Congress of the European Academy of Neurology.
 

An ‘ambitious exercise’

Coinvestigator Xaviera Steele, also from the IHME, told press conference attendees that the institute was established at the University of Washington in 2007 with the aim of “standardizing the measurement of health outcomes around the world and for all health conditions.”

A central part of that is the GBD study, “which is a very ambitious exercise in descriptive epidemiology in an effort to systematically quantify health loss” due to disease, injury, and risk factors over time, stratified by country, region, age, and sex. In addition, researchers are mapping and projecting trends over the next century and are estimating disease expenditure by country, by type of expense, and by condition “to derive a health care access and quality score for each health system in the world,” Ms. Steele said.

They are also estimating exposure to risk factors, how those risk factors contribute to health burden, and associated health outcomes by race and ethnicity to reflect the “disparities that we know are very prevalent in countries such as the United States.” From that work, Ms. Steele said that brain health and related conditions “do emerge as one of the more pressing challenges of the 21st century.”
 

Increase in dementia, mental health conditions

The data, which were gathered from 200,000 sources by the IHME, indicate that the number of individuals aged 65 years or older will increase by 350% by 2100. Ms. Steele underlined that “policy action will be needed to help families, who will struggle to provide high-quality care for their loved ones with dementia at a reasonable cost.”

The IHME calculates that in Europe health care spending on Alzheimer’s disease will increase by 226% between 2015 and 2040.

Turning to other conditions, Ms. Steele showed that since 1990, the number of individuals living with anxiety in the European region has increased by 14%, while the number living with depressive disorders has gone up by 13%.

Worldwide, the figures are even starker. Depression is estimated to affect 300 million people across the globe, which represents a 71% increase since 1990. The number of strokes increased by 95% over the same period.

Nevertheless, the “impact of brain conditions such as stroke has decreased since the 1990s due to improved treatments available,” Ms. Smith noted in the press release.

To estimate the toll caused by brain conditions, including neurologic disorders, mental disorders, cerebrovascular disease, brain cancer, brain injuries, and select infectious conditions, the researchers calculated disability-adjusted life years (DALYs).

This, Ms. Smith explained in her presentation, “captures the morbidity and mortality associated with brain conditions” and is adjusted for patient location, age, and sex.

The investigators found that, globally, brain conditions accounted for more than 15% of all health loss in 2021, at 406 DALYs – more than the 206 million DALYs that were associated with cancer, and the 402 million that were linked to cardiovascular disease.

This health loss is associated with a $1.22 trillion loss in income for people living with health disorders worldwide and accounts for $1.14 trillion in direct health care costs.

The burden of mental disorders, neurologic conditions, and stroke is expected to increase dramatically between now and 2050, said Ms. Smith, who noted that health loss linked to brain conditions is higher in younger patients. This will create “new challenges for health systems, employers, patients, and families,” she said in the press release.

“Our goal is to see an improved prevention and treatment landscape for other brain conditions and reverse the growing health loss that we are currently forecasting.”
 

Worrying increase in stroke

Jurgita Valaikiene, MD, PhD, center of neurology, clinic of neurology and neurosurgery, Vilnius (Lithuania) University Faculty of Medicine, who chaired the session, was taken aback by the findings, particularly by the worldwide increase in stroke cases.

“I work in stroke,” she said, and “we spend a lot of time on the diagnosis of stroke” and its prevention. “We try to be faster, to catch asymptomatic stenosis in the neck or head, and to apply the best medical treatment to avoid a stroke. But despite that, the numbers are increasing. I understand the population is getting older ... but still it’s a huge number.”

Dr. Valaikiene pointed out that stroke is not necessarily a condition of aging, insofar as increasing age “is not related directly to stenosis in the neck. “For example, we can have healthier vessels in older age and unhealthy vessels, with high-grade stenosis, in someone aged 30 or 40 years.”

“There are a lot of risk factors, such as smoking, physical activity, and so on. It depends on the individual,” she added.

The study was funded by the Institute for Health Metrics and Evaluation at the University of Washington. The authors have disclosed no relevant financial relationships.

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

Brain disorders, including mental illness, neurologic conditions, and stroke, account for more than 15% of all health loss worldwide – more than either cardiovascular disease or cancer – at huge cost to health care systems and society, an analysis of data from the most recent Global Burden of Disease (GBD) study shows.

“The burden of brain conditions will increase as populations continue to grow and age,” said study presenter Shayla Smith, MPH, an epidemiologist at the Institute for Health Metrics and Evaluation, the University of Washington, Seattle, in a press release.

“By 2050, more than 50 million people will be aged 65-79,” she explained, adding that the COVID-19 pandemic “has also influenced the prevalence of mental disorders globally, as people were forced to isolate and social networks broke down.”

Other factors related to brain disorders, she noted, include education level, obesity, and smoking.

“There’s still research to be done on what is the most effective way to maintain brain health, but some literature suggests a healthy brain can be achieved through a healthy lifestyle of managing conditions such as high blood pressure and diabetes, limiting alcohol consumption and smoking, prioritizing sleep, eating healthy, and staying physically and mentally active,” said Ms. Smith.

The findings were presented at the annual meeting of the Congress of the European Academy of Neurology.
 

An ‘ambitious exercise’

Coinvestigator Xaviera Steele, also from the IHME, told press conference attendees that the institute was established at the University of Washington in 2007 with the aim of “standardizing the measurement of health outcomes around the world and for all health conditions.”

A central part of that is the GBD study, “which is a very ambitious exercise in descriptive epidemiology in an effort to systematically quantify health loss” due to disease, injury, and risk factors over time, stratified by country, region, age, and sex. In addition, researchers are mapping and projecting trends over the next century and are estimating disease expenditure by country, by type of expense, and by condition “to derive a health care access and quality score for each health system in the world,” Ms. Steele said.

They are also estimating exposure to risk factors, how those risk factors contribute to health burden, and associated health outcomes by race and ethnicity to reflect the “disparities that we know are very prevalent in countries such as the United States.” From that work, Ms. Steele said that brain health and related conditions “do emerge as one of the more pressing challenges of the 21st century.”
 

Increase in dementia, mental health conditions

The data, which were gathered from 200,000 sources by the IHME, indicate that the number of individuals aged 65 years or older will increase by 350% by 2100. Ms. Steele underlined that “policy action will be needed to help families, who will struggle to provide high-quality care for their loved ones with dementia at a reasonable cost.”

The IHME calculates that in Europe health care spending on Alzheimer’s disease will increase by 226% between 2015 and 2040.

Turning to other conditions, Ms. Steele showed that since 1990, the number of individuals living with anxiety in the European region has increased by 14%, while the number living with depressive disorders has gone up by 13%.

Worldwide, the figures are even starker. Depression is estimated to affect 300 million people across the globe, which represents a 71% increase since 1990. The number of strokes increased by 95% over the same period.

Nevertheless, the “impact of brain conditions such as stroke has decreased since the 1990s due to improved treatments available,” Ms. Smith noted in the press release.

To estimate the toll caused by brain conditions, including neurologic disorders, mental disorders, cerebrovascular disease, brain cancer, brain injuries, and select infectious conditions, the researchers calculated disability-adjusted life years (DALYs).

This, Ms. Smith explained in her presentation, “captures the morbidity and mortality associated with brain conditions” and is adjusted for patient location, age, and sex.

The investigators found that, globally, brain conditions accounted for more than 15% of all health loss in 2021, at 406 DALYs – more than the 206 million DALYs that were associated with cancer, and the 402 million that were linked to cardiovascular disease.

This health loss is associated with a $1.22 trillion loss in income for people living with health disorders worldwide and accounts for $1.14 trillion in direct health care costs.

The burden of mental disorders, neurologic conditions, and stroke is expected to increase dramatically between now and 2050, said Ms. Smith, who noted that health loss linked to brain conditions is higher in younger patients. This will create “new challenges for health systems, employers, patients, and families,” she said in the press release.

“Our goal is to see an improved prevention and treatment landscape for other brain conditions and reverse the growing health loss that we are currently forecasting.”
 

Worrying increase in stroke

Jurgita Valaikiene, MD, PhD, center of neurology, clinic of neurology and neurosurgery, Vilnius (Lithuania) University Faculty of Medicine, who chaired the session, was taken aback by the findings, particularly by the worldwide increase in stroke cases.

“I work in stroke,” she said, and “we spend a lot of time on the diagnosis of stroke” and its prevention. “We try to be faster, to catch asymptomatic stenosis in the neck or head, and to apply the best medical treatment to avoid a stroke. But despite that, the numbers are increasing. I understand the population is getting older ... but still it’s a huge number.”

Dr. Valaikiene pointed out that stroke is not necessarily a condition of aging, insofar as increasing age “is not related directly to stenosis in the neck. “For example, we can have healthier vessels in older age and unhealthy vessels, with high-grade stenosis, in someone aged 30 or 40 years.”

“There are a lot of risk factors, such as smoking, physical activity, and so on. It depends on the individual,” she added.

The study was funded by the Institute for Health Metrics and Evaluation at the University of Washington. The authors have disclosed no relevant financial relationships.

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

In the decade since safe, curative oral treatments were approved for treating hepatitis C virus (HCV) infections, only one in three U.S. patients diagnosed with the disease have been cleared of it, according to new data from the Centers for Disease Control and Prevention.

The findings indicate that current progress falls far short of the goal of the Viral Hepatitis National Strategic Plan for the United States, which calls for eliminating HCV for at least 80% of patients with the virus by 2030.

Lead author Carolyn Wester, MD, with the CDC’s Division of Viral Hepatitis, called the low numbers “stunning” and said that the researchers found that patients face barriers to being cured at every step of the way, from being diagnosed to accessing breakthrough direct-acting antiviral (DAA) agents.

The article was published online in the CDC’s Morbidity and Mortality Weekly Report.
 

Outcomes vary by age and insurance

Using longitudinal data from Quest Diagnostics laboratories, the researchers identified 1.7 million people who had a history of HCV infection from Jan. 1, 2013, to Dec. 31, 2022.

Of those patients, 1.5 million (88%) were categorized as having undergone viral testing.

Among those who underwent such testing, 1 million (69%) were categorized as having an initial infection. Just 356,807 patients with initial infection (34%) were cured or cleared of HCV. Of those found to be cured or cleared, 23,518 (7%) were found to have persistent infection or reinfection.

Viral clearance varied greatly by insurance. While 45% of the people covered under Medicare experienced viral clearance, only 23% of the uninsured and 31% of those on Medicaid did so.

Age also played a role in viral clearance. It was highest (42%) among those aged 60 and older. Clearance was lowest (24%) among patients in the 20-39 age group, the group most likely to be newly infected in light of the surge in HCV cases because of the opioid epidemic, Dr. Wester said. Persistent infection or reinfection was also highest in the 20-39 age group.

With respect to age and insurance type combined, the highest HCV clearance rate (49%) was for patients aged 60 and older who had commercial insurance; the lowest (16%) was for uninsured patients in the 20-39 age group.

The investigators evaluated people who had been diagnosed with HCV, Dr. Wester said. “It’s estimated about 40% of people in the U.S. are unaware of their infection.” Because of this, the numbers reported in the study may vastly underestimate the true picture, she told this news organization.
 

Barriers to treatment ‘insurmountable’ without major transformation

Increased access to diagnosis, treatment, and prevention services for persons with or at risk for acquiring hepatitis C needs to be addressed to prevent progression of disease and ongoing transmission and to achieve national hepatitis C elimination goals, the authors wrote.

The biggest barriers to improving HCV clearance are the high cost of treatment, widely varying insurance coverage, insurer restrictions, and challenges in diagnosing the disease, Dr. Wester added.

Overcoming these barriers requires implementation of universal HCV screening recommendations, including HCV RNA testing for all persons with reactive HCV antibody results, provision of treatment for all persons regardless of payer, and prevention services for persons at risk for acquiring new HCV infection, the authors concluded.

“The current barriers are insurmountable without a major transformation in our nation’s response,” Dr. Wester noted.

She expressed her support of the National Hepatitis C Elimination Program, offered as part of the Biden Administration’s 2024 budget proposal. She said that the initiative “is what we need to prevent the needless suffering from hepatitis C and to potentially save not only tens of thousands of lives but tens of billions of health care dollars.”

The three-part proposal includes a national subscription model to purchase DAA agents for those most underserved: Medicaid beneficiaries, incarcerated people, the uninsured, and American Indian and Alaska Native individuals treated through the Indian Health Service.

Under this model, the federal government would negotiate with manufacturers to buy as much treatment as needed for all individuals in the underserved groups.
 

What can physicians do?

Physicians can help improve HCV treatment and outcomes by being aware of the current testing guidelines, Dr. Wester said.

Guidelines now call for hepatitis C screening at least once in a lifetime for all adults, except in settings where the prevalence of HCV infection is less than 0.1%. They also call for screening during each pregnancy, with the same regional-prevalence exception.

Recommendations include curative treatment “for nearly everybody who is living with hepatitis C,” Dr. Wester added.

These CDC guidelines came out in April 2020, a time when the medical focus shifted to COVID-19, and that may have hurt awareness, she noted.

Physicians can also help by fighting back against non–evidence-based reasons insurance companies give for restricting coverage, Dr. Wester said.

Those restrictions include requiring specialists to prescribe DAA agents instead of allowing primary care physicians to do so, as well as requiring patients to have advanced liver disease or requiring patients to demonstrate sobriety or prove they are receiving counseling prior to their being eligible for treatment, Dr. Wester said.
 

Prior authorization a problem

Stacey B. Trooskin MD, PhD, MPH, assistant professor of medicine at the University of Pennsylvania in Philadelphia, told this news organization that prior authorization has been a major barrier for obtaining medications. Prior authorization requirements differ by state.

The paperwork must be submitted by already-stretched physician offices, and appeals are common. In that time, the window for keeping patients with HCV in the health care system may be lost, said Dr. Trooskin, chief medical adviser to the National Viral Hepatitis Roundtable.

“We know that about half of all Medicaid programs have removed prior authorization for most patients entirely,” she said, “but there are still half that require prior authorization.”

Action at the federal level is also needed, Dr. Trooskin said.

The countries that are successfully eliminating HCV and have successfully deployed the lifesaving medications provide governmental support for meeting patients where they are, she added.

Support can include inpatient and outpatient substance use disorder treatment programs or support in mental health settings, she noted.

“It’s not enough to want patients to come into their primary care provider and for that primary care provider to screen them,” Dr. Trooskin said. “This is about creating health care infrastructure so that we are finding patients at greatest risk for hepatitis C and integrating hepatitis C treatment into the services they are already accessing.”

Coauthor Harvey W. Kaufman, MD, is an employee of and owns stock in Quest Diagnostics. Coauthor William A. Meyer III, PhD, is a consultant to Quest Diagnostics. No other potential conflicts of interest were disclosed. Dr. Trooskin oversees C-Change, a hepatitis C elimination program, which receives funding from Gilead Sciences.

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

In the decade since safe, curative oral treatments were approved for treating hepatitis C virus (HCV) infections, only one in three U.S. patients diagnosed with the disease have been cleared of it, according to new data from the Centers for Disease Control and Prevention.

The findings indicate that current progress falls far short of the goal of the Viral Hepatitis National Strategic Plan for the United States, which calls for eliminating HCV for at least 80% of patients with the virus by 2030.

Lead author Carolyn Wester, MD, with the CDC’s Division of Viral Hepatitis, called the low numbers “stunning” and said that the researchers found that patients face barriers to being cured at every step of the way, from being diagnosed to accessing breakthrough direct-acting antiviral (DAA) agents.

The article was published online in the CDC’s Morbidity and Mortality Weekly Report.
 

Outcomes vary by age and insurance

Using longitudinal data from Quest Diagnostics laboratories, the researchers identified 1.7 million people who had a history of HCV infection from Jan. 1, 2013, to Dec. 31, 2022.

Of those patients, 1.5 million (88%) were categorized as having undergone viral testing.

Among those who underwent such testing, 1 million (69%) were categorized as having an initial infection. Just 356,807 patients with initial infection (34%) were cured or cleared of HCV. Of those found to be cured or cleared, 23,518 (7%) were found to have persistent infection or reinfection.

Viral clearance varied greatly by insurance. While 45% of the people covered under Medicare experienced viral clearance, only 23% of the uninsured and 31% of those on Medicaid did so.

Age also played a role in viral clearance. It was highest (42%) among those aged 60 and older. Clearance was lowest (24%) among patients in the 20-39 age group, the group most likely to be newly infected in light of the surge in HCV cases because of the opioid epidemic, Dr. Wester said. Persistent infection or reinfection was also highest in the 20-39 age group.

With respect to age and insurance type combined, the highest HCV clearance rate (49%) was for patients aged 60 and older who had commercial insurance; the lowest (16%) was for uninsured patients in the 20-39 age group.

The investigators evaluated people who had been diagnosed with HCV, Dr. Wester said. “It’s estimated about 40% of people in the U.S. are unaware of their infection.” Because of this, the numbers reported in the study may vastly underestimate the true picture, she told this news organization.
 

Barriers to treatment ‘insurmountable’ without major transformation

Increased access to diagnosis, treatment, and prevention services for persons with or at risk for acquiring hepatitis C needs to be addressed to prevent progression of disease and ongoing transmission and to achieve national hepatitis C elimination goals, the authors wrote.

The biggest barriers to improving HCV clearance are the high cost of treatment, widely varying insurance coverage, insurer restrictions, and challenges in diagnosing the disease, Dr. Wester added.

Overcoming these barriers requires implementation of universal HCV screening recommendations, including HCV RNA testing for all persons with reactive HCV antibody results, provision of treatment for all persons regardless of payer, and prevention services for persons at risk for acquiring new HCV infection, the authors concluded.

“The current barriers are insurmountable without a major transformation in our nation’s response,” Dr. Wester noted.

She expressed her support of the National Hepatitis C Elimination Program, offered as part of the Biden Administration’s 2024 budget proposal. She said that the initiative “is what we need to prevent the needless suffering from hepatitis C and to potentially save not only tens of thousands of lives but tens of billions of health care dollars.”

The three-part proposal includes a national subscription model to purchase DAA agents for those most underserved: Medicaid beneficiaries, incarcerated people, the uninsured, and American Indian and Alaska Native individuals treated through the Indian Health Service.

Under this model, the federal government would negotiate with manufacturers to buy as much treatment as needed for all individuals in the underserved groups.
 

What can physicians do?

Physicians can help improve HCV treatment and outcomes by being aware of the current testing guidelines, Dr. Wester said.

Guidelines now call for hepatitis C screening at least once in a lifetime for all adults, except in settings where the prevalence of HCV infection is less than 0.1%. They also call for screening during each pregnancy, with the same regional-prevalence exception.

Recommendations include curative treatment “for nearly everybody who is living with hepatitis C,” Dr. Wester added.

These CDC guidelines came out in April 2020, a time when the medical focus shifted to COVID-19, and that may have hurt awareness, she noted.

Physicians can also help by fighting back against non–evidence-based reasons insurance companies give for restricting coverage, Dr. Wester said.

Those restrictions include requiring specialists to prescribe DAA agents instead of allowing primary care physicians to do so, as well as requiring patients to have advanced liver disease or requiring patients to demonstrate sobriety or prove they are receiving counseling prior to their being eligible for treatment, Dr. Wester said.
 

Prior authorization a problem

Stacey B. Trooskin MD, PhD, MPH, assistant professor of medicine at the University of Pennsylvania in Philadelphia, told this news organization that prior authorization has been a major barrier for obtaining medications. Prior authorization requirements differ by state.

The paperwork must be submitted by already-stretched physician offices, and appeals are common. In that time, the window for keeping patients with HCV in the health care system may be lost, said Dr. Trooskin, chief medical adviser to the National Viral Hepatitis Roundtable.

“We know that about half of all Medicaid programs have removed prior authorization for most patients entirely,” she said, “but there are still half that require prior authorization.”

Action at the federal level is also needed, Dr. Trooskin said.

The countries that are successfully eliminating HCV and have successfully deployed the lifesaving medications provide governmental support for meeting patients where they are, she added.

Support can include inpatient and outpatient substance use disorder treatment programs or support in mental health settings, she noted.

“It’s not enough to want patients to come into their primary care provider and for that primary care provider to screen them,” Dr. Trooskin said. “This is about creating health care infrastructure so that we are finding patients at greatest risk for hepatitis C and integrating hepatitis C treatment into the services they are already accessing.”

Coauthor Harvey W. Kaufman, MD, is an employee of and owns stock in Quest Diagnostics. Coauthor William A. Meyer III, PhD, is a consultant to Quest Diagnostics. No other potential conflicts of interest were disclosed. Dr. Trooskin oversees C-Change, a hepatitis C elimination program, which receives funding from Gilead Sciences.

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

In the decade since safe, curative oral treatments were approved for treating hepatitis C virus (HCV) infections, only one in three U.S. patients diagnosed with the disease have been cleared of it, according to new data from the Centers for Disease Control and Prevention.

The findings indicate that current progress falls far short of the goal of the Viral Hepatitis National Strategic Plan for the United States, which calls for eliminating HCV for at least 80% of patients with the virus by 2030.

Lead author Carolyn Wester, MD, with the CDC’s Division of Viral Hepatitis, called the low numbers “stunning” and said that the researchers found that patients face barriers to being cured at every step of the way, from being diagnosed to accessing breakthrough direct-acting antiviral (DAA) agents.

The article was published online in the CDC’s Morbidity and Mortality Weekly Report.
 

Outcomes vary by age and insurance

Using longitudinal data from Quest Diagnostics laboratories, the researchers identified 1.7 million people who had a history of HCV infection from Jan. 1, 2013, to Dec. 31, 2022.

Of those patients, 1.5 million (88%) were categorized as having undergone viral testing.

Among those who underwent such testing, 1 million (69%) were categorized as having an initial infection. Just 356,807 patients with initial infection (34%) were cured or cleared of HCV. Of those found to be cured or cleared, 23,518 (7%) were found to have persistent infection or reinfection.

Viral clearance varied greatly by insurance. While 45% of the people covered under Medicare experienced viral clearance, only 23% of the uninsured and 31% of those on Medicaid did so.

Age also played a role in viral clearance. It was highest (42%) among those aged 60 and older. Clearance was lowest (24%) among patients in the 20-39 age group, the group most likely to be newly infected in light of the surge in HCV cases because of the opioid epidemic, Dr. Wester said. Persistent infection or reinfection was also highest in the 20-39 age group.

With respect to age and insurance type combined, the highest HCV clearance rate (49%) was for patients aged 60 and older who had commercial insurance; the lowest (16%) was for uninsured patients in the 20-39 age group.

The investigators evaluated people who had been diagnosed with HCV, Dr. Wester said. “It’s estimated about 40% of people in the U.S. are unaware of their infection.” Because of this, the numbers reported in the study may vastly underestimate the true picture, she told this news organization.
 

Barriers to treatment ‘insurmountable’ without major transformation

Increased access to diagnosis, treatment, and prevention services for persons with or at risk for acquiring hepatitis C needs to be addressed to prevent progression of disease and ongoing transmission and to achieve national hepatitis C elimination goals, the authors wrote.

The biggest barriers to improving HCV clearance are the high cost of treatment, widely varying insurance coverage, insurer restrictions, and challenges in diagnosing the disease, Dr. Wester added.

Overcoming these barriers requires implementation of universal HCV screening recommendations, including HCV RNA testing for all persons with reactive HCV antibody results, provision of treatment for all persons regardless of payer, and prevention services for persons at risk for acquiring new HCV infection, the authors concluded.

“The current barriers are insurmountable without a major transformation in our nation’s response,” Dr. Wester noted.

She expressed her support of the National Hepatitis C Elimination Program, offered as part of the Biden Administration’s 2024 budget proposal. She said that the initiative “is what we need to prevent the needless suffering from hepatitis C and to potentially save not only tens of thousands of lives but tens of billions of health care dollars.”

The three-part proposal includes a national subscription model to purchase DAA agents for those most underserved: Medicaid beneficiaries, incarcerated people, the uninsured, and American Indian and Alaska Native individuals treated through the Indian Health Service.

Under this model, the federal government would negotiate with manufacturers to buy as much treatment as needed for all individuals in the underserved groups.
 

What can physicians do?

Physicians can help improve HCV treatment and outcomes by being aware of the current testing guidelines, Dr. Wester said.

Guidelines now call for hepatitis C screening at least once in a lifetime for all adults, except in settings where the prevalence of HCV infection is less than 0.1%. They also call for screening during each pregnancy, with the same regional-prevalence exception.

Recommendations include curative treatment “for nearly everybody who is living with hepatitis C,” Dr. Wester added.

These CDC guidelines came out in April 2020, a time when the medical focus shifted to COVID-19, and that may have hurt awareness, she noted.

Physicians can also help by fighting back against non–evidence-based reasons insurance companies give for restricting coverage, Dr. Wester said.

Those restrictions include requiring specialists to prescribe DAA agents instead of allowing primary care physicians to do so, as well as requiring patients to have advanced liver disease or requiring patients to demonstrate sobriety or prove they are receiving counseling prior to their being eligible for treatment, Dr. Wester said.
 

Prior authorization a problem

Stacey B. Trooskin MD, PhD, MPH, assistant professor of medicine at the University of Pennsylvania in Philadelphia, told this news organization that prior authorization has been a major barrier for obtaining medications. Prior authorization requirements differ by state.

The paperwork must be submitted by already-stretched physician offices, and appeals are common. In that time, the window for keeping patients with HCV in the health care system may be lost, said Dr. Trooskin, chief medical adviser to the National Viral Hepatitis Roundtable.

“We know that about half of all Medicaid programs have removed prior authorization for most patients entirely,” she said, “but there are still half that require prior authorization.”

Action at the federal level is also needed, Dr. Trooskin said.

The countries that are successfully eliminating HCV and have successfully deployed the lifesaving medications provide governmental support for meeting patients where they are, she added.

Support can include inpatient and outpatient substance use disorder treatment programs or support in mental health settings, she noted.

“It’s not enough to want patients to come into their primary care provider and for that primary care provider to screen them,” Dr. Trooskin said. “This is about creating health care infrastructure so that we are finding patients at greatest risk for hepatitis C and integrating hepatitis C treatment into the services they are already accessing.”

Coauthor Harvey W. Kaufman, MD, is an employee of and owns stock in Quest Diagnostics. Coauthor William A. Meyer III, PhD, is a consultant to Quest Diagnostics. No other potential conflicts of interest were disclosed. Dr. Trooskin oversees C-Change, a hepatitis C elimination program, which receives funding from Gilead Sciences.

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

Like many stressful chronic conditions, hearing loss appears to foster fatigue, according to an analysis of National Health and Nutrition Examination Study data published in JAMA Otolaryngology – Head & Neck Surgery.

Researchers at Johns Hopkins University, Baltimore, examined NHANES data from 2015 to 2016 and 2017 to 2018, including findings on more than 3,000 participants aged 40 and older. Based on the audiometry subset of NHANES data, hearing loss was associated with a higher frequency of fatigue – even after adjustment for demographics, comorbidities, and lifestyle variables such as smoking, alcohol, and body mass index, in a nationally representative sample of adults in middle and older age.

“We wanted to get away from small clinical data and take a look at the population level to see if hearing loss was related to fatigue and, further perhaps, to cognitive decline,” said coauthor Nicholas S. Reed, AuD, PhD, an assistant professor of epidemiology at Johns Hopkins University, Baltimore, in an interview. “We found people with hearing loss had twice the risk of reporting fatigue nearly every day versus those not reporting fatigue.” This cross-sectional study provides needed population-based evidence from a nationally representative sample, according to Dr. Reed and associates, who have been researching the possible connection between age-related hearing loss, physical activity levels, and cognitive decline.
 

Study details

The 3,031 age-eligible participants had a mean age of 58 years; 48% were male, and 10% were Black. Some hearing loss was reported by 24%.

They responded to the following question: “Over the last 2 weeks, how often have you been bothered by feeling tired or having little energy?” Response categories were “not at all,” “several days,” “more than half the days,” and “nearly every day.” Those with hearing loss were more likely to report fatigue for more than half the days (relative risk ratio, 2.16; 95% confidence interval, 1.27-3.67) and nearly every day (RRR, 2.05; 95% CI, 1.16-3.65), compared with not having fatigue. Additional adjustment for comorbidities and depressive symptoms showed similar results.

Hearing loss was defined as > 25 decibels hearing level (dB HL) versus normal hearing of ≤ 25 dB HL, and continuously by every 10 dB HL poorer. Each 10-dB HL of audiometric hearing loss was associated with a higher likelihood of reporting fatigue nearly every day (RRR, 1.24; 95% CI,1.04-1.47), but not for more than half the days.

The association tended to be stronger in younger, non-Hispanic White, and female participants, but statistical testing did not support differential associations by age, sex, race, or ethnicity.

While some might intuitively expect hearing loss to cause noticeably more fatigue in middle-aged people who may be straining to hear during hours in the daily workplace or at home, Dr. Reed said older people probably feel more hearing-related fatigue owing to age and comorbidities. “And higher physical activity levels of middle-aged adults can be protective.”

Dr. Reed advised primary care physicians to be sure to ask about fatigue and hearing status during wellness exams and take appropriate steps to diagnose and correct hearing problems. “Make sure hearing is part of the health equation because hearing loss can be part of the culprit. And it’s very possible that hearing loss is also contributing to cognitive decline.”

Dr. Reed’s group will soon release data on a clinical trial on hearing loss and cognitive decline.

The authors called for studies incorporating fatigue assessments in order to clarify how hearing loss might contribute to physical and mental fatigue and how it could be associated with downstream outcomes such as fatigue-related physical impairment. Dr. Reed reported grants from the National Institute on Aging during the conduct of the study and stock compensation from the Neosensory Advisory Board outside of the submitted work. Several coauthors reported academic or government research funding as well as fees and honoraria from various private-sector companies.

Like many stressful chronic conditions, hearing loss appears to foster fatigue, according to an analysis of National Health and Nutrition Examination Study data published in JAMA Otolaryngology – Head & Neck Surgery.

Researchers at Johns Hopkins University, Baltimore, examined NHANES data from 2015 to 2016 and 2017 to 2018, including findings on more than 3,000 participants aged 40 and older. Based on the audiometry subset of NHANES data, hearing loss was associated with a higher frequency of fatigue – even after adjustment for demographics, comorbidities, and lifestyle variables such as smoking, alcohol, and body mass index, in a nationally representative sample of adults in middle and older age.

“We wanted to get away from small clinical data and take a look at the population level to see if hearing loss was related to fatigue and, further perhaps, to cognitive decline,” said coauthor Nicholas S. Reed, AuD, PhD, an assistant professor of epidemiology at Johns Hopkins University, Baltimore, in an interview. “We found people with hearing loss had twice the risk of reporting fatigue nearly every day versus those not reporting fatigue.” This cross-sectional study provides needed population-based evidence from a nationally representative sample, according to Dr. Reed and associates, who have been researching the possible connection between age-related hearing loss, physical activity levels, and cognitive decline.
 

Study details

The 3,031 age-eligible participants had a mean age of 58 years; 48% were male, and 10% were Black. Some hearing loss was reported by 24%.

They responded to the following question: “Over the last 2 weeks, how often have you been bothered by feeling tired or having little energy?” Response categories were “not at all,” “several days,” “more than half the days,” and “nearly every day.” Those with hearing loss were more likely to report fatigue for more than half the days (relative risk ratio, 2.16; 95% confidence interval, 1.27-3.67) and nearly every day (RRR, 2.05; 95% CI, 1.16-3.65), compared with not having fatigue. Additional adjustment for comorbidities and depressive symptoms showed similar results.

Hearing loss was defined as > 25 decibels hearing level (dB HL) versus normal hearing of ≤ 25 dB HL, and continuously by every 10 dB HL poorer. Each 10-dB HL of audiometric hearing loss was associated with a higher likelihood of reporting fatigue nearly every day (RRR, 1.24; 95% CI,1.04-1.47), but not for more than half the days.

The association tended to be stronger in younger, non-Hispanic White, and female participants, but statistical testing did not support differential associations by age, sex, race, or ethnicity.

While some might intuitively expect hearing loss to cause noticeably more fatigue in middle-aged people who may be straining to hear during hours in the daily workplace or at home, Dr. Reed said older people probably feel more hearing-related fatigue owing to age and comorbidities. “And higher physical activity levels of middle-aged adults can be protective.”

Dr. Reed advised primary care physicians to be sure to ask about fatigue and hearing status during wellness exams and take appropriate steps to diagnose and correct hearing problems. “Make sure hearing is part of the health equation because hearing loss can be part of the culprit. And it’s very possible that hearing loss is also contributing to cognitive decline.”

Dr. Reed’s group will soon release data on a clinical trial on hearing loss and cognitive decline.

The authors called for studies incorporating fatigue assessments in order to clarify how hearing loss might contribute to physical and mental fatigue and how it could be associated with downstream outcomes such as fatigue-related physical impairment. Dr. Reed reported grants from the National Institute on Aging during the conduct of the study and stock compensation from the Neosensory Advisory Board outside of the submitted work. Several coauthors reported academic or government research funding as well as fees and honoraria from various private-sector companies.

Like many stressful chronic conditions, hearing loss appears to foster fatigue, according to an analysis of National Health and Nutrition Examination Study data published in JAMA Otolaryngology – Head & Neck Surgery.

Researchers at Johns Hopkins University, Baltimore, examined NHANES data from 2015 to 2016 and 2017 to 2018, including findings on more than 3,000 participants aged 40 and older. Based on the audiometry subset of NHANES data, hearing loss was associated with a higher frequency of fatigue – even after adjustment for demographics, comorbidities, and lifestyle variables such as smoking, alcohol, and body mass index, in a nationally representative sample of adults in middle and older age.

“We wanted to get away from small clinical data and take a look at the population level to see if hearing loss was related to fatigue and, further perhaps, to cognitive decline,” said coauthor Nicholas S. Reed, AuD, PhD, an assistant professor of epidemiology at Johns Hopkins University, Baltimore, in an interview. “We found people with hearing loss had twice the risk of reporting fatigue nearly every day versus those not reporting fatigue.” This cross-sectional study provides needed population-based evidence from a nationally representative sample, according to Dr. Reed and associates, who have been researching the possible connection between age-related hearing loss, physical activity levels, and cognitive decline.
 

Study details

The 3,031 age-eligible participants had a mean age of 58 years; 48% were male, and 10% were Black. Some hearing loss was reported by 24%.

They responded to the following question: “Over the last 2 weeks, how often have you been bothered by feeling tired or having little energy?” Response categories were “not at all,” “several days,” “more than half the days,” and “nearly every day.” Those with hearing loss were more likely to report fatigue for more than half the days (relative risk ratio, 2.16; 95% confidence interval, 1.27-3.67) and nearly every day (RRR, 2.05; 95% CI, 1.16-3.65), compared with not having fatigue. Additional adjustment for comorbidities and depressive symptoms showed similar results.

Hearing loss was defined as > 25 decibels hearing level (dB HL) versus normal hearing of ≤ 25 dB HL, and continuously by every 10 dB HL poorer. Each 10-dB HL of audiometric hearing loss was associated with a higher likelihood of reporting fatigue nearly every day (RRR, 1.24; 95% CI,1.04-1.47), but not for more than half the days.

The association tended to be stronger in younger, non-Hispanic White, and female participants, but statistical testing did not support differential associations by age, sex, race, or ethnicity.

While some might intuitively expect hearing loss to cause noticeably more fatigue in middle-aged people who may be straining to hear during hours in the daily workplace or at home, Dr. Reed said older people probably feel more hearing-related fatigue owing to age and comorbidities. “And higher physical activity levels of middle-aged adults can be protective.”

Dr. Reed advised primary care physicians to be sure to ask about fatigue and hearing status during wellness exams and take appropriate steps to diagnose and correct hearing problems. “Make sure hearing is part of the health equation because hearing loss can be part of the culprit. And it’s very possible that hearing loss is also contributing to cognitive decline.”

Dr. Reed’s group will soon release data on a clinical trial on hearing loss and cognitive decline.

The authors called for studies incorporating fatigue assessments in order to clarify how hearing loss might contribute to physical and mental fatigue and how it could be associated with downstream outcomes such as fatigue-related physical impairment. Dr. Reed reported grants from the National Institute on Aging during the conduct of the study and stock compensation from the Neosensory Advisory Board outside of the submitted work. Several coauthors reported academic or government research funding as well as fees and honoraria from various private-sector companies.

A close examination of the patient’s scalp and hair was unhelpful, but a close look at the weave and seams of her dress revealed multiple nits and lice, consistent with a diagnosis of body lice.

Head lice and body lice are 2 different ecotypes of the species Pediculus humanus and occupy different environments on the body. They differ slightly in body shape caused by variable expression of the same genes.¹ Body lice primarily live and lay eggs on clothing, especially along seams and within knit weaves. They travel to the skin to feed, causing significant itching in the host from the inflammatory and allergic effects of their saliva and feces. Additionally, body lice are vectors of several serious diseases including epidemic typhus (Rickettsia prowasekii), trench fever (Bartonella quintana), and relapsing fever (Borrelia recurrentis).¹

A diagnosis of body lice is a sign of severe lack of access to basic human needs—uncrowded shelter, clean clothes, and clean water for bathing. A patient who has been given this diagnosis should be offered and receive a bath or shower with generous soap and warm water. Clothes should be cleaned with hot water (up to 149 °F) or discarded. Patients also may be treated once with topical permethrin 5% cream applied from the top of the neck to the toes in the event that mites survived bathing by attaching to body hairs. Any systemic illness or fever should be evaluated for the above epidemic pathogens. Patients should also be put in touch with social services and mental health services, as appropriate.

This patient received all of the above treatments and had already accessed social services. That said, she continued to struggle with housing instability.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

A close examination of the patient’s scalp and hair was unhelpful, but a close look at the weave and seams of her dress revealed multiple nits and lice, consistent with a diagnosis of body lice.

Head lice and body lice are 2 different ecotypes of the species Pediculus humanus and occupy different environments on the body. They differ slightly in body shape caused by variable expression of the same genes.¹ Body lice primarily live and lay eggs on clothing, especially along seams and within knit weaves. They travel to the skin to feed, causing significant itching in the host from the inflammatory and allergic effects of their saliva and feces. Additionally, body lice are vectors of several serious diseases including epidemic typhus (Rickettsia prowasekii), trench fever (Bartonella quintana), and relapsing fever (Borrelia recurrentis).¹

A diagnosis of body lice is a sign of severe lack of access to basic human needs—uncrowded shelter, clean clothes, and clean water for bathing. A patient who has been given this diagnosis should be offered and receive a bath or shower with generous soap and warm water. Clothes should be cleaned with hot water (up to 149 °F) or discarded. Patients also may be treated once with topical permethrin 5% cream applied from the top of the neck to the toes in the event that mites survived bathing by attaching to body hairs. Any systemic illness or fever should be evaluated for the above epidemic pathogens. Patients should also be put in touch with social services and mental health services, as appropriate.

This patient received all of the above treatments and had already accessed social services. That said, she continued to struggle with housing instability.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

A close examination of the patient’s scalp and hair was unhelpful, but a close look at the weave and seams of her dress revealed multiple nits and lice, consistent with a diagnosis of body lice.

Head lice and body lice are 2 different ecotypes of the species Pediculus humanus and occupy different environments on the body. They differ slightly in body shape caused by variable expression of the same genes.¹ Body lice primarily live and lay eggs on clothing, especially along seams and within knit weaves. They travel to the skin to feed, causing significant itching in the host from the inflammatory and allergic effects of their saliva and feces. Additionally, body lice are vectors of several serious diseases including epidemic typhus (Rickettsia prowasekii), trench fever (Bartonella quintana), and relapsing fever (Borrelia recurrentis).¹

A diagnosis of body lice is a sign of severe lack of access to basic human needs—uncrowded shelter, clean clothes, and clean water for bathing. A patient who has been given this diagnosis should be offered and receive a bath or shower with generous soap and warm water. Clothes should be cleaned with hot water (up to 149 °F) or discarded. Patients also may be treated once with topical permethrin 5% cream applied from the top of the neck to the toes in the event that mites survived bathing by attaching to body hairs. Any systemic illness or fever should be evaluated for the above epidemic pathogens. Patients should also be put in touch with social services and mental health services, as appropriate.

This patient received all of the above treatments and had already accessed social services. That said, she continued to struggle with housing instability.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

Severe itching should prompt suspicion for scabies and the hands are the highest-yield location. In this patient’s case, there weren’t findings in the web spaces and, in general, skin findings were largely absent; dermoscopy confirmed the diagnosis of scabies.

Sarcoptes scabiei, is a parasitic mite that lives and reproduces in and on human skin and is transmitted by very close contact, either skin-to-skin or by living within a household or institution with shared linens and furnishings. After infection, itching develops within days to weeks from both the physical movement and burrowing of mites within the skin and from the allergic and inflammatory response to mite bodies and their waste.¹ Symptoms and infections may persist for years in the absence of treatment.

Sometimes (as in this case), burrows are few and very subtle. More often, there are widespread burrows and excoriated papules over the hands, trunk, extremities, and genitals. A burrowed mite is often adjacent to, but not directly in, an excoriation. Dermoscopy has transformed the ability to diagnose this condition quickly by enabling clinicians to visualize the triangular shape of the head and front legs of a mite (called the “delta sign”). This localization allows easy microscopic confirmation by paring the mite from the skin with a small scalpel blade. (A #11 or #15 blade works very well.)

Topical permethrin 5% cream is highly curative. The cream should be applied from the top of the neck to the tips of the patient’s toes and left on for 8 hours; the process should be repeated a week later. Very close contacts (eg, symptomatic household members or sexual partners) should be treated concurrently. A 60 g tube will treat 1 adult twice. (A 60 g tube of permethrin with a refill, therefore, will treat 2 adults twice.) Oral ivermectin 3 mg dosed at 200 mcg/kg in a single dose repeated in 1 to 2 weeks is an alternative.

Outbreaks in an institutional setting present a significant challenge and require population-based control and often the assistance of infection control specialists or local public health officials. Often this involves weekly treatment with ivermectin for all potentially affected individuals for 3 to 4 weeks and surveillance for follow-up. While there is some resistance to ivermectin, many failures relate more to reinfection from unidentified sources.

This patient received topical permethrin 5% cream dosed as noted above. Itching can be expected to persist for 3 to 4 weeks, so topical triamcinolone 0.1% cream was prescribed as needed for itching on days when permethrin wasn’t applied. At 6 weeks, this patient’s symptoms had resolved.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

Severe itching should prompt suspicion for scabies and the hands are the highest-yield location. In this patient’s case, there weren’t findings in the web spaces and, in general, skin findings were largely absent; dermoscopy confirmed the diagnosis of scabies.

Sarcoptes scabiei, is a parasitic mite that lives and reproduces in and on human skin and is transmitted by very close contact, either skin-to-skin or by living within a household or institution with shared linens and furnishings. After infection, itching develops within days to weeks from both the physical movement and burrowing of mites within the skin and from the allergic and inflammatory response to mite bodies and their waste.¹ Symptoms and infections may persist for years in the absence of treatment.

Sometimes (as in this case), burrows are few and very subtle. More often, there are widespread burrows and excoriated papules over the hands, trunk, extremities, and genitals. A burrowed mite is often adjacent to, but not directly in, an excoriation. Dermoscopy has transformed the ability to diagnose this condition quickly by enabling clinicians to visualize the triangular shape of the head and front legs of a mite (called the “delta sign”). This localization allows easy microscopic confirmation by paring the mite from the skin with a small scalpel blade. (A #11 or #15 blade works very well.)

Topical permethrin 5% cream is highly curative. The cream should be applied from the top of the neck to the tips of the patient’s toes and left on for 8 hours; the process should be repeated a week later. Very close contacts (eg, symptomatic household members or sexual partners) should be treated concurrently. A 60 g tube will treat 1 adult twice. (A 60 g tube of permethrin with a refill, therefore, will treat 2 adults twice.) Oral ivermectin 3 mg dosed at 200 mcg/kg in a single dose repeated in 1 to 2 weeks is an alternative.

Outbreaks in an institutional setting present a significant challenge and require population-based control and often the assistance of infection control specialists or local public health officials. Often this involves weekly treatment with ivermectin for all potentially affected individuals for 3 to 4 weeks and surveillance for follow-up. While there is some resistance to ivermectin, many failures relate more to reinfection from unidentified sources.

This patient received topical permethrin 5% cream dosed as noted above. Itching can be expected to persist for 3 to 4 weeks, so topical triamcinolone 0.1% cream was prescribed as needed for itching on days when permethrin wasn’t applied. At 6 weeks, this patient’s symptoms had resolved.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

Severe itching should prompt suspicion for scabies and the hands are the highest-yield location. In this patient’s case, there weren’t findings in the web spaces and, in general, skin findings were largely absent; dermoscopy confirmed the diagnosis of scabies.

Sarcoptes scabiei, is a parasitic mite that lives and reproduces in and on human skin and is transmitted by very close contact, either skin-to-skin or by living within a household or institution with shared linens and furnishings. After infection, itching develops within days to weeks from both the physical movement and burrowing of mites within the skin and from the allergic and inflammatory response to mite bodies and their waste.¹ Symptoms and infections may persist for years in the absence of treatment.

Sometimes (as in this case), burrows are few and very subtle. More often, there are widespread burrows and excoriated papules over the hands, trunk, extremities, and genitals. A burrowed mite is often adjacent to, but not directly in, an excoriation. Dermoscopy has transformed the ability to diagnose this condition quickly by enabling clinicians to visualize the triangular shape of the head and front legs of a mite (called the “delta sign”). This localization allows easy microscopic confirmation by paring the mite from the skin with a small scalpel blade. (A #11 or #15 blade works very well.)

Topical permethrin 5% cream is highly curative. The cream should be applied from the top of the neck to the tips of the patient’s toes and left on for 8 hours; the process should be repeated a week later. Very close contacts (eg, symptomatic household members or sexual partners) should be treated concurrently. A 60 g tube will treat 1 adult twice. (A 60 g tube of permethrin with a refill, therefore, will treat 2 adults twice.) Oral ivermectin 3 mg dosed at 200 mcg/kg in a single dose repeated in 1 to 2 weeks is an alternative.

Outbreaks in an institutional setting present a significant challenge and require population-based control and often the assistance of infection control specialists or local public health officials. Often this involves weekly treatment with ivermectin for all potentially affected individuals for 3 to 4 weeks and surveillance for follow-up. While there is some resistance to ivermectin, many failures relate more to reinfection from unidentified sources.

This patient received topical permethrin 5% cream dosed as noted above. Itching can be expected to persist for 3 to 4 weeks, so topical triamcinolone 0.1% cream was prescribed as needed for itching on days when permethrin wasn’t applied. At 6 weeks, this patient’s symptoms had resolved.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

The American Academy of Pediatrics’ (AAP) Community Access to Child Health is celebrating its 30th anniversary this year. Known by the acronym CATCH, this program provides seed funding to chapters and pediatricians at all stages of their training and practice trajectories to assist in the planing and development of community-based initiatives aimed at increasing children’s access to a variety of health services. While relatively modest in its scale and profile, the CATCH-funded recipients have a strong track record of creating effective and often sustainable projects serving children in historically underserved segments of the community.

In a recent article by Rupal C. Gupta, MD, FAAP, I encountered a quote attributed to Benjamin D. Hoffman, MD, president-elect of the AAP, who served as a chapter CATCH facilitator. Dr. Hoffman observed that “part of the solution to burnout is doing meaningful work, and CATCH allows you to do that.” I couldn’t agree more with Dr. Hoffman’s claim. There is no question that viewing your professional activities as meaningless can be a major contributor to burnout. And, community involvement can certainly provide ample opportunities to do meaningful work.

As a pediatrician who worked, lived, and raised his children in the same small community, I found that seeing and interacting with my patients and their families outside the office in a variety of environments, from the grocery store to the soccer field, and a variety of roles, from coach to school physician, added a richness to my professional life.

I suspect that living in and serving the community where I practiced may have helped provide some meaning on those very rare occasions when I wondered why I was heading off to work in the morning ... or in the middle of the night. But, 90% of the time I felt what I was doing as a physician was somehow making a difference. Nothing earth shaking or worthy of sainthood mind you, but if I were to take the time to look back on my day and weighed the meaningful against the meaningless activities it would almost always tip the scales toward meaningful. But, I seldom had the time to engage in such retrospection.

It seems that many physicians today are not finding that same meaningful versus meaningless balance that I enjoyed. Is it because they are spending too little of their time doing meaningful work? Has the management of the more common illnesses become too routine or so algorithm-driven that it is no longer challenging? One solution to that problem is to shift our focus from the disease to the patient. Diagnosing and managing strep throat is not a terribly challenging intellectual exercise until you realize it is the unique way in which each patient presents and tolerates the illness.

I think the answer is not that there is too little meaningful work for physicians today, and I suspect that you would agree. We are all lucky to have jobs that almost by definition offer an abundance of meaningful activities. There are situations in which it may require a bit of an attitude change to see the meaningfulness, but the opportunities are there. No, the problem seems to be that there is an overabundance of meaningless tasks that confront physicians. Clunky, time-gobbling medical record systems, fighting with insurance companies, chasing down prior authorizations, attending committee meetings in a top-heavy organization with too many meetings, _____________. You can fill in the blank with your favorite. Every job has its meaningful and meaningless components. The problem is that we in primary care medicine are facing a landscape in which the meaningless seems to be dominating our days.

The CATCH program can offer you a way to rebalance that imbalance, and, by all means, consider applying for a grant. But, where we need to put our energies is in the search for solutions to the glut of meaningless tasks that are burning us out. We shouldn’t have to seek meaningful experiences outside of our offices. They have always been there, hidden under the mountain of meaningless chores.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

The American Academy of Pediatrics’ (AAP) Community Access to Child Health is celebrating its 30th anniversary this year. Known by the acronym CATCH, this program provides seed funding to chapters and pediatricians at all stages of their training and practice trajectories to assist in the planing and development of community-based initiatives aimed at increasing children’s access to a variety of health services. While relatively modest in its scale and profile, the CATCH-funded recipients have a strong track record of creating effective and often sustainable projects serving children in historically underserved segments of the community.

In a recent article by Rupal C. Gupta, MD, FAAP, I encountered a quote attributed to Benjamin D. Hoffman, MD, president-elect of the AAP, who served as a chapter CATCH facilitator. Dr. Hoffman observed that “part of the solution to burnout is doing meaningful work, and CATCH allows you to do that.” I couldn’t agree more with Dr. Hoffman’s claim. There is no question that viewing your professional activities as meaningless can be a major contributor to burnout. And, community involvement can certainly provide ample opportunities to do meaningful work.

As a pediatrician who worked, lived, and raised his children in the same small community, I found that seeing and interacting with my patients and their families outside the office in a variety of environments, from the grocery store to the soccer field, and a variety of roles, from coach to school physician, added a richness to my professional life.

I suspect that living in and serving the community where I practiced may have helped provide some meaning on those very rare occasions when I wondered why I was heading off to work in the morning ... or in the middle of the night. But, 90% of the time I felt what I was doing as a physician was somehow making a difference. Nothing earth shaking or worthy of sainthood mind you, but if I were to take the time to look back on my day and weighed the meaningful against the meaningless activities it would almost always tip the scales toward meaningful. But, I seldom had the time to engage in such retrospection.

It seems that many physicians today are not finding that same meaningful versus meaningless balance that I enjoyed. Is it because they are spending too little of their time doing meaningful work? Has the management of the more common illnesses become too routine or so algorithm-driven that it is no longer challenging? One solution to that problem is to shift our focus from the disease to the patient. Diagnosing and managing strep throat is not a terribly challenging intellectual exercise until you realize it is the unique way in which each patient presents and tolerates the illness.

I think the answer is not that there is too little meaningful work for physicians today, and I suspect that you would agree. We are all lucky to have jobs that almost by definition offer an abundance of meaningful activities. There are situations in which it may require a bit of an attitude change to see the meaningfulness, but the opportunities are there. No, the problem seems to be that there is an overabundance of meaningless tasks that confront physicians. Clunky, time-gobbling medical record systems, fighting with insurance companies, chasing down prior authorizations, attending committee meetings in a top-heavy organization with too many meetings, _____________. You can fill in the blank with your favorite. Every job has its meaningful and meaningless components. The problem is that we in primary care medicine are facing a landscape in which the meaningless seems to be dominating our days.

The CATCH program can offer you a way to rebalance that imbalance, and, by all means, consider applying for a grant. But, where we need to put our energies is in the search for solutions to the glut of meaningless tasks that are burning us out. We shouldn’t have to seek meaningful experiences outside of our offices. They have always been there, hidden under the mountain of meaningless chores.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

The American Academy of Pediatrics’ (AAP) Community Access to Child Health is celebrating its 30th anniversary this year. Known by the acronym CATCH, this program provides seed funding to chapters and pediatricians at all stages of their training and practice trajectories to assist in the planing and development of community-based initiatives aimed at increasing children’s access to a variety of health services. While relatively modest in its scale and profile, the CATCH-funded recipients have a strong track record of creating effective and often sustainable projects serving children in historically underserved segments of the community.

In a recent article by Rupal C. Gupta, MD, FAAP, I encountered a quote attributed to Benjamin D. Hoffman, MD, president-elect of the AAP, who served as a chapter CATCH facilitator. Dr. Hoffman observed that “part of the solution to burnout is doing meaningful work, and CATCH allows you to do that.” I couldn’t agree more with Dr. Hoffman’s claim. There is no question that viewing your professional activities as meaningless can be a major contributor to burnout. And, community involvement can certainly provide ample opportunities to do meaningful work.

As a pediatrician who worked, lived, and raised his children in the same small community, I found that seeing and interacting with my patients and their families outside the office in a variety of environments, from the grocery store to the soccer field, and a variety of roles, from coach to school physician, added a richness to my professional life.

I suspect that living in and serving the community where I practiced may have helped provide some meaning on those very rare occasions when I wondered why I was heading off to work in the morning ... or in the middle of the night. But, 90% of the time I felt what I was doing as a physician was somehow making a difference. Nothing earth shaking or worthy of sainthood mind you, but if I were to take the time to look back on my day and weighed the meaningful against the meaningless activities it would almost always tip the scales toward meaningful. But, I seldom had the time to engage in such retrospection.

It seems that many physicians today are not finding that same meaningful versus meaningless balance that I enjoyed. Is it because they are spending too little of their time doing meaningful work? Has the management of the more common illnesses become too routine or so algorithm-driven that it is no longer challenging? One solution to that problem is to shift our focus from the disease to the patient. Diagnosing and managing strep throat is not a terribly challenging intellectual exercise until you realize it is the unique way in which each patient presents and tolerates the illness.

I think the answer is not that there is too little meaningful work for physicians today, and I suspect that you would agree. We are all lucky to have jobs that almost by definition offer an abundance of meaningful activities. There are situations in which it may require a bit of an attitude change to see the meaningfulness, but the opportunities are there. No, the problem seems to be that there is an overabundance of meaningless tasks that confront physicians. Clunky, time-gobbling medical record systems, fighting with insurance companies, chasing down prior authorizations, attending committee meetings in a top-heavy organization with too many meetings, _____________. You can fill in the blank with your favorite. Every job has its meaningful and meaningless components. The problem is that we in primary care medicine are facing a landscape in which the meaningless seems to be dominating our days.

The CATCH program can offer you a way to rebalance that imbalance, and, by all means, consider applying for a grant. But, where we need to put our energies is in the search for solutions to the glut of meaningless tasks that are burning us out. We shouldn’t have to seek meaningful experiences outside of our offices. They have always been there, hidden under the mountain of meaningless chores.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Nonalcoholic fatty liver disease will now be called metabolic dysfunction–associated steatotic liver disease, or MASLD, according to new nomenclature adopted by a global consensus panel composed mostly of hepatology researchers and clinicians.

The new nomenclature, published in the journal Hepatology, includes the umbrella term steatotic liver disease, or SLD, which will cover MASLD and MetALD, a term describing people with MASLD who consume more than 140 grams of alcohol per week for women and 210 grams per week for men.

Metabolic dysfunction–associated steatohepatitis, or MASH, will replace the term nonalcoholic steatohepatitis, or NASH.

Mary E. Rinella, MD, of University of Chicago Medicine led the consensus group. The changes were needed, Dr. Rinella and her colleagues argued, because the terms “fatty liver disease” “and nonalcoholic” could be considered to confer stigma, and to better reflect the metabolic dysfunction occurring in the disease. Under the new nomenclature, people with MASLD must have a cardiometabolic risk factor, such as type 2 diabetes. People without metabolic parameters and no known cause will be classed as having cryptogenic SLD.

While the new nomenclature largely conserves existing disease definitions, it allows for alcohol consumption beyond current parameters for nonalcoholic forms of the disease. “There are individuals with risk factors for NAFLD, such as type 2 diabetes, who consume more alcohol than the relatively strict thresholds used to define the nonalcoholic nature of the disease [and] are excluded from trials and consideration for treatments,” the authors wrote.

Moreover, they wrote, “within MetALD there is a continuum where conceptually the condition can be seen to be MASLD or ALD predominant. This may vary over time within a given individual.”

Respondents overwhelmingly agreed, however, that even moderate alcohol use alters the natural history of the disease and that patients with more than minimal alcohol consumption should be analyzed separately in clinical trials.

The new nomenclature reflects a 3-year effort involving some 236 panelists from 56 countries who participated in several rounds of online surveys using a Delphi process. Pediatricians, gastroenterologists, and endocrinologists also participated as well as some patient advocates. Changes were based on a super-majority of opinion (67% or higher), though the consensus on whether the term “fatty” was stigmatizing never reached that threshold. In early rounds of surveys only 44% of respondents considered the word “fatty” to be stigmatizing, while more considered “nonalcoholic” to be problematic.

“Substantial proportions of the respondents deemed terms such as ‘fatty’ stigmatizing, hence its exclusion as part of any new name,” Dr. Rinella and her colleagues wrote. “Although health care professionals may contend that patients have not reported this previously, this likely reflects in part a failure to ask the question in the first place and the power imbalance in the doctor-patient relationship.” The authors noted that the new terminology may help raise awareness at a time when new therapeutics are in sight and it becomes more important to identify at-risk individuals.

Of concern was whether the new definitions would alter the utility of earlier data from registries and trials. However, the authors determined that some 98% of people registered in a European NAFLD cohort would meet the new criteria for MASLD. “Maintenance of the term, and clinical definition, of steatohepatitis ensures retention and validity of prior data from clinical trials and biomarker discovery studies of patients with NASH to be generalizable to individuals classified as MASLD or MASH under the new nomenclature, without impeding the efficiency of research,” they stated.

The effort was spearheaded by three international liver societies: La Asociación Latinoamericana para el Estudio del Hígado, the American Association for the Study of Liver Diseases, and the European Association for the Study of the Liver, as well as the cochairs of the NAFLD Nomenclature Initiative.

Each of the authors disclosed a number of potential conflicts of interest.

Nonalcoholic fatty liver disease will now be called metabolic dysfunction–associated steatotic liver disease, or MASLD, according to new nomenclature adopted by a global consensus panel composed mostly of hepatology researchers and clinicians.

The new nomenclature, published in the journal Hepatology, includes the umbrella term steatotic liver disease, or SLD, which will cover MASLD and MetALD, a term describing people with MASLD who consume more than 140 grams of alcohol per week for women and 210 grams per week for men.

Metabolic dysfunction–associated steatohepatitis, or MASH, will replace the term nonalcoholic steatohepatitis, or NASH.

Mary E. Rinella, MD, of University of Chicago Medicine led the consensus group. The changes were needed, Dr. Rinella and her colleagues argued, because the terms “fatty liver disease” “and nonalcoholic” could be considered to confer stigma, and to better reflect the metabolic dysfunction occurring in the disease. Under the new nomenclature, people with MASLD must have a cardiometabolic risk factor, such as type 2 diabetes. People without metabolic parameters and no known cause will be classed as having cryptogenic SLD.

While the new nomenclature largely conserves existing disease definitions, it allows for alcohol consumption beyond current parameters for nonalcoholic forms of the disease. “There are individuals with risk factors for NAFLD, such as type 2 diabetes, who consume more alcohol than the relatively strict thresholds used to define the nonalcoholic nature of the disease [and] are excluded from trials and consideration for treatments,” the authors wrote.

Moreover, they wrote, “within MetALD there is a continuum where conceptually the condition can be seen to be MASLD or ALD predominant. This may vary over time within a given individual.”

Respondents overwhelmingly agreed, however, that even moderate alcohol use alters the natural history of the disease and that patients with more than minimal alcohol consumption should be analyzed separately in clinical trials.

The new nomenclature reflects a 3-year effort involving some 236 panelists from 56 countries who participated in several rounds of online surveys using a Delphi process. Pediatricians, gastroenterologists, and endocrinologists also participated as well as some patient advocates. Changes were based on a super-majority of opinion (67% or higher), though the consensus on whether the term “fatty” was stigmatizing never reached that threshold. In early rounds of surveys only 44% of respondents considered the word “fatty” to be stigmatizing, while more considered “nonalcoholic” to be problematic.

“Substantial proportions of the respondents deemed terms such as ‘fatty’ stigmatizing, hence its exclusion as part of any new name,” Dr. Rinella and her colleagues wrote. “Although health care professionals may contend that patients have not reported this previously, this likely reflects in part a failure to ask the question in the first place and the power imbalance in the doctor-patient relationship.” The authors noted that the new terminology may help raise awareness at a time when new therapeutics are in sight and it becomes more important to identify at-risk individuals.

Of concern was whether the new definitions would alter the utility of earlier data from registries and trials. However, the authors determined that some 98% of people registered in a European NAFLD cohort would meet the new criteria for MASLD. “Maintenance of the term, and clinical definition, of steatohepatitis ensures retention and validity of prior data from clinical trials and biomarker discovery studies of patients with NASH to be generalizable to individuals classified as MASLD or MASH under the new nomenclature, without impeding the efficiency of research,” they stated.

The effort was spearheaded by three international liver societies: La Asociación Latinoamericana para el Estudio del Hígado, the American Association for the Study of Liver Diseases, and the European Association for the Study of the Liver, as well as the cochairs of the NAFLD Nomenclature Initiative.

Each of the authors disclosed a number of potential conflicts of interest.

Nonalcoholic fatty liver disease will now be called metabolic dysfunction–associated steatotic liver disease, or MASLD, according to new nomenclature adopted by a global consensus panel composed mostly of hepatology researchers and clinicians.

The new nomenclature, published in the journal Hepatology, includes the umbrella term steatotic liver disease, or SLD, which will cover MASLD and MetALD, a term describing people with MASLD who consume more than 140 grams of alcohol per week for women and 210 grams per week for men.

Metabolic dysfunction–associated steatohepatitis, or MASH, will replace the term nonalcoholic steatohepatitis, or NASH.

Mary E. Rinella, MD, of University of Chicago Medicine led the consensus group. The changes were needed, Dr. Rinella and her colleagues argued, because the terms “fatty liver disease” “and nonalcoholic” could be considered to confer stigma, and to better reflect the metabolic dysfunction occurring in the disease. Under the new nomenclature, people with MASLD must have a cardiometabolic risk factor, such as type 2 diabetes. People without metabolic parameters and no known cause will be classed as having cryptogenic SLD.

While the new nomenclature largely conserves existing disease definitions, it allows for alcohol consumption beyond current parameters for nonalcoholic forms of the disease. “There are individuals with risk factors for NAFLD, such as type 2 diabetes, who consume more alcohol than the relatively strict thresholds used to define the nonalcoholic nature of the disease [and] are excluded from trials and consideration for treatments,” the authors wrote.

Moreover, they wrote, “within MetALD there is a continuum where conceptually the condition can be seen to be MASLD or ALD predominant. This may vary over time within a given individual.”

Respondents overwhelmingly agreed, however, that even moderate alcohol use alters the natural history of the disease and that patients with more than minimal alcohol consumption should be analyzed separately in clinical trials.

The new nomenclature reflects a 3-year effort involving some 236 panelists from 56 countries who participated in several rounds of online surveys using a Delphi process. Pediatricians, gastroenterologists, and endocrinologists also participated as well as some patient advocates. Changes were based on a super-majority of opinion (67% or higher), though the consensus on whether the term “fatty” was stigmatizing never reached that threshold. In early rounds of surveys only 44% of respondents considered the word “fatty” to be stigmatizing, while more considered “nonalcoholic” to be problematic.

“Substantial proportions of the respondents deemed terms such as ‘fatty’ stigmatizing, hence its exclusion as part of any new name,” Dr. Rinella and her colleagues wrote. “Although health care professionals may contend that patients have not reported this previously, this likely reflects in part a failure to ask the question in the first place and the power imbalance in the doctor-patient relationship.” The authors noted that the new terminology may help raise awareness at a time when new therapeutics are in sight and it becomes more important to identify at-risk individuals.

Of concern was whether the new definitions would alter the utility of earlier data from registries and trials. However, the authors determined that some 98% of people registered in a European NAFLD cohort would meet the new criteria for MASLD. “Maintenance of the term, and clinical definition, of steatohepatitis ensures retention and validity of prior data from clinical trials and biomarker discovery studies of patients with NASH to be generalizable to individuals classified as MASLD or MASH under the new nomenclature, without impeding the efficiency of research,” they stated.

The effort was spearheaded by three international liver societies: La Asociación Latinoamericana para el Estudio del Hígado, the American Association for the Study of Liver Diseases, and the European Association for the Study of the Liver, as well as the cochairs of the NAFLD Nomenclature Initiative.

Each of the authors disclosed a number of potential conflicts of interest.