Diversity in Medicine

Practice Gap

Lichen planus (LP) is an inflammatory cutaneous disorder. Although it often is characterized by the 6 Ps—pruritic, polygonal, planar, purple, papules, and plaques with a predilection for the wrists and ankles—the presentation can vary in morphology and distribution.^1-5 With an incidence of approximately 1% in the general population, LP is undoubtedly uncommon.¹ Its prevalence in the pediatric population is especially low, with only 2% to 3% of cases manifesting in individuals younger than 20 years.²

Generalized LP (also referred to as eruptive or exanthematous LP) is a rarely reported clinical subtype in which lesions are disseminated or spread rapidly.⁵ The rarity of generalized LP in children often leads to misdiagnosis or delayed treatment, impacting the patient’s quality of life. Thus, there is a need for heightened awareness among clinicians on the variable presentation of LP in the pediatric population. Incorporating a punch biopsy for the diagnosis of LP when lesions manifest as widespread, erythematous to violaceous, flat-topped papules or plaques, along with the addition of an intramuscular (IM) injection in the treatment plan, improves overall patient outcomes.

Tools and Techniques

A detailed physical examination followed by a punch biopsy was critical for the diagnosis of generalized LP in a 7-year-old Black girl. The examination revealed a widespread distribution of dark, violaceous, polygonal, shiny, flat-topped, firm papules coalescing into plaques across the entire body, with a greater predilection for the legs and overlying joints (Figure, A). Some lesions exhibited fine, silver-white, reticular patterns consistent with Wickham striae. Notably, there was no involvement of the scalp, nails, or mucosal surfaces.

The patient had no relevant medical or family history of skin disease and no recent history of illness. She previously was treated by a pediatrician with triamcinolone cream 0.1%, a course of oral cephalexin, and oral cetirizine 10 mg once daily without relief of symptoms.

Although the clinical presentation was consistent with LP, the differential diagnosis included lichen simplex chronicus, atopic dermatitis, psoriasis, and generalized granuloma annulare. To address the need for early recognition of LP in pediatric patients, a punch biopsy of a lesion on the left anterior thigh was performed and showed lichenoid interface dermatitis—a pivotal finding in distinguishing LP from other conditions in the differential.

Given the patient’s age and severity of the LP, a combination of topical and systemic therapies was prescribed—clobetasol cream 0.025% twice daily and 1 injection of 0.5 cc of IM triamcinolone acetonide 40 mg/mL. This regimen was guided by the efficacy of IM injections in providing prompt symptomatic relief, particularly for patients with extensive disease or for those whose condition is refractory to topical treatments.⁶ Our patient achieved remarkable improvement at 2-week ­follow-up (Figure, B), without any observed adverse effects. At that time, the patient’s mother refused further systemic treatment and opted for only the topical therapy as well as natural light therapy.

Practice Implications

Timely and accurate diagnosis of LP in pediatric patients, especially those with skin of color, is crucial. Early intervention is especially important in mitigating the risk for chronic symptoms and preventing potential scarring, which tends to be more pronounced and challenging to treat in individuals with darker skin tones.⁷ Although not present in our patient, it is important to note that LP can affect the face (including the eyelids) as well as the palms and soles in pediatric patients with skin of color.

The most common approach to management of pediatric LP involves the use of a topical corticosteroid and an oral antihistamine, but the recalcitrant and generalized distribution of lesions warrants the administration of a systemic corticosteroid regardless of the patient’s age.⁶ In our patient, prompt administration of low-dose IM triamcinolone was both crucial and beneficial. Although an underutilized approach, IM triamcinolone helps to prevent the progression of lesions to the scalp, nails, and mucosa while also reducing inflammation and pruritus in glabrous skin.⁸

Triamcinolone acetonide injections—­administered at concentrations of 5 to 40 mg/mL—directly into the lesion (0.5–1 cc per 2 cm²) are highly effective in managing recalcitrant thickened lesions such as those seen in hypertrophic LP and palmoplantar LP.⁶ This treatment is particularly beneficial when lesions are unresponsive to topical therapies. Administered every 3 to 6 weeks, these injections provide rapid symptom relief, typically within 72 hours,⁶ while also contributing to the reduction of lesion size and thickness over time. The concentration of triamcinolone acetonide should be selected based on the lesion’s severity, with higher concentrations reserved for thicker, more resistant lesions. More frequent injections may be warranted in cases in which rapid lesion reduction is necessary, while less frequent sessions may suffice for maintenance therapy. It is important to follow patients closely for adverse effects, such as signs of local skin atrophy or hypopigmentation, and to adjust the dose or frequency accordingly. To mitigate these risks, consider using the lowest effective concentration and rotating injection sites if treating multiple lesions. Additionally, combining intralesional corticosteroids with topical therapies can enhance outcomes, particularly in cases in which monotherapy is insufficient.

Patients should be monitored vigilantly for complications of LP. The risk for postinflammatory hyperpigmentation is a particular concern for patients with skin of color. Other complications of untreated LP include nail deformities and scarring alopecia.⁹ Regular and thorough follow-ups every few months to monitor scalp, mucosal, and genital involvement are essential to manage this risk effectively.

Furthermore, patient education is key. Informing patients and their caregivers about the nature of LP, the available treatment options, and the importance of ongoing follow-up can help to enhance treatment adherence and improve overall outcomes.

Practice Gap

Lichen planus (LP) is an inflammatory cutaneous disorder. Although it often is characterized by the 6 Ps—pruritic, polygonal, planar, purple, papules, and plaques with a predilection for the wrists and ankles—the presentation can vary in morphology and distribution.^1-5 With an incidence of approximately 1% in the general population, LP is undoubtedly uncommon.¹ Its prevalence in the pediatric population is especially low, with only 2% to 3% of cases manifesting in individuals younger than 20 years.²

Generalized LP (also referred to as eruptive or exanthematous LP) is a rarely reported clinical subtype in which lesions are disseminated or spread rapidly.⁵ The rarity of generalized LP in children often leads to misdiagnosis or delayed treatment, impacting the patient’s quality of life. Thus, there is a need for heightened awareness among clinicians on the variable presentation of LP in the pediatric population. Incorporating a punch biopsy for the diagnosis of LP when lesions manifest as widespread, erythematous to violaceous, flat-topped papules or plaques, along with the addition of an intramuscular (IM) injection in the treatment plan, improves overall patient outcomes.

Tools and Techniques

A detailed physical examination followed by a punch biopsy was critical for the diagnosis of generalized LP in a 7-year-old Black girl. The examination revealed a widespread distribution of dark, violaceous, polygonal, shiny, flat-topped, firm papules coalescing into plaques across the entire body, with a greater predilection for the legs and overlying joints (Figure, A). Some lesions exhibited fine, silver-white, reticular patterns consistent with Wickham striae. Notably, there was no involvement of the scalp, nails, or mucosal surfaces.

The patient had no relevant medical or family history of skin disease and no recent history of illness. She previously was treated by a pediatrician with triamcinolone cream 0.1%, a course of oral cephalexin, and oral cetirizine 10 mg once daily without relief of symptoms.

Although the clinical presentation was consistent with LP, the differential diagnosis included lichen simplex chronicus, atopic dermatitis, psoriasis, and generalized granuloma annulare. To address the need for early recognition of LP in pediatric patients, a punch biopsy of a lesion on the left anterior thigh was performed and showed lichenoid interface dermatitis—a pivotal finding in distinguishing LP from other conditions in the differential.

Given the patient’s age and severity of the LP, a combination of topical and systemic therapies was prescribed—clobetasol cream 0.025% twice daily and 1 injection of 0.5 cc of IM triamcinolone acetonide 40 mg/mL. This regimen was guided by the efficacy of IM injections in providing prompt symptomatic relief, particularly for patients with extensive disease or for those whose condition is refractory to topical treatments.⁶ Our patient achieved remarkable improvement at 2-week ­follow-up (Figure, B), without any observed adverse effects. At that time, the patient’s mother refused further systemic treatment and opted for only the topical therapy as well as natural light therapy.

Practice Implications

Timely and accurate diagnosis of LP in pediatric patients, especially those with skin of color, is crucial. Early intervention is especially important in mitigating the risk for chronic symptoms and preventing potential scarring, which tends to be more pronounced and challenging to treat in individuals with darker skin tones.⁷ Although not present in our patient, it is important to note that LP can affect the face (including the eyelids) as well as the palms and soles in pediatric patients with skin of color.

The most common approach to management of pediatric LP involves the use of a topical corticosteroid and an oral antihistamine, but the recalcitrant and generalized distribution of lesions warrants the administration of a systemic corticosteroid regardless of the patient’s age.⁶ In our patient, prompt administration of low-dose IM triamcinolone was both crucial and beneficial. Although an underutilized approach, IM triamcinolone helps to prevent the progression of lesions to the scalp, nails, and mucosa while also reducing inflammation and pruritus in glabrous skin.⁸

Triamcinolone acetonide injections—­administered at concentrations of 5 to 40 mg/mL—directly into the lesion (0.5–1 cc per 2 cm²) are highly effective in managing recalcitrant thickened lesions such as those seen in hypertrophic LP and palmoplantar LP.⁶ This treatment is particularly beneficial when lesions are unresponsive to topical therapies. Administered every 3 to 6 weeks, these injections provide rapid symptom relief, typically within 72 hours,⁶ while also contributing to the reduction of lesion size and thickness over time. The concentration of triamcinolone acetonide should be selected based on the lesion’s severity, with higher concentrations reserved for thicker, more resistant lesions. More frequent injections may be warranted in cases in which rapid lesion reduction is necessary, while less frequent sessions may suffice for maintenance therapy. It is important to follow patients closely for adverse effects, such as signs of local skin atrophy or hypopigmentation, and to adjust the dose or frequency accordingly. To mitigate these risks, consider using the lowest effective concentration and rotating injection sites if treating multiple lesions. Additionally, combining intralesional corticosteroids with topical therapies can enhance outcomes, particularly in cases in which monotherapy is insufficient.

Patients should be monitored vigilantly for complications of LP. The risk for postinflammatory hyperpigmentation is a particular concern for patients with skin of color. Other complications of untreated LP include nail deformities and scarring alopecia.⁹ Regular and thorough follow-ups every few months to monitor scalp, mucosal, and genital involvement are essential to manage this risk effectively.

Furthermore, patient education is key. Informing patients and their caregivers about the nature of LP, the available treatment options, and the importance of ongoing follow-up can help to enhance treatment adherence and improve overall outcomes.

Practice Gap

Lichen planus (LP) is an inflammatory cutaneous disorder. Although it often is characterized by the 6 Ps—pruritic, polygonal, planar, purple, papules, and plaques with a predilection for the wrists and ankles—the presentation can vary in morphology and distribution.^1-5 With an incidence of approximately 1% in the general population, LP is undoubtedly uncommon.¹ Its prevalence in the pediatric population is especially low, with only 2% to 3% of cases manifesting in individuals younger than 20 years.²

Generalized LP (also referred to as eruptive or exanthematous LP) is a rarely reported clinical subtype in which lesions are disseminated or spread rapidly.⁵ The rarity of generalized LP in children often leads to misdiagnosis or delayed treatment, impacting the patient’s quality of life. Thus, there is a need for heightened awareness among clinicians on the variable presentation of LP in the pediatric population. Incorporating a punch biopsy for the diagnosis of LP when lesions manifest as widespread, erythematous to violaceous, flat-topped papules or plaques, along with the addition of an intramuscular (IM) injection in the treatment plan, improves overall patient outcomes.

Tools and Techniques

A detailed physical examination followed by a punch biopsy was critical for the diagnosis of generalized LP in a 7-year-old Black girl. The examination revealed a widespread distribution of dark, violaceous, polygonal, shiny, flat-topped, firm papules coalescing into plaques across the entire body, with a greater predilection for the legs and overlying joints (Figure, A). Some lesions exhibited fine, silver-white, reticular patterns consistent with Wickham striae. Notably, there was no involvement of the scalp, nails, or mucosal surfaces.

The patient had no relevant medical or family history of skin disease and no recent history of illness. She previously was treated by a pediatrician with triamcinolone cream 0.1%, a course of oral cephalexin, and oral cetirizine 10 mg once daily without relief of symptoms.

Although the clinical presentation was consistent with LP, the differential diagnosis included lichen simplex chronicus, atopic dermatitis, psoriasis, and generalized granuloma annulare. To address the need for early recognition of LP in pediatric patients, a punch biopsy of a lesion on the left anterior thigh was performed and showed lichenoid interface dermatitis—a pivotal finding in distinguishing LP from other conditions in the differential.

Given the patient’s age and severity of the LP, a combination of topical and systemic therapies was prescribed—clobetasol cream 0.025% twice daily and 1 injection of 0.5 cc of IM triamcinolone acetonide 40 mg/mL. This regimen was guided by the efficacy of IM injections in providing prompt symptomatic relief, particularly for patients with extensive disease or for those whose condition is refractory to topical treatments.⁶ Our patient achieved remarkable improvement at 2-week ­follow-up (Figure, B), without any observed adverse effects. At that time, the patient’s mother refused further systemic treatment and opted for only the topical therapy as well as natural light therapy.

Practice Implications

Timely and accurate diagnosis of LP in pediatric patients, especially those with skin of color, is crucial. Early intervention is especially important in mitigating the risk for chronic symptoms and preventing potential scarring, which tends to be more pronounced and challenging to treat in individuals with darker skin tones.⁷ Although not present in our patient, it is important to note that LP can affect the face (including the eyelids) as well as the palms and soles in pediatric patients with skin of color.

The most common approach to management of pediatric LP involves the use of a topical corticosteroid and an oral antihistamine, but the recalcitrant and generalized distribution of lesions warrants the administration of a systemic corticosteroid regardless of the patient’s age.⁶ In our patient, prompt administration of low-dose IM triamcinolone was both crucial and beneficial. Although an underutilized approach, IM triamcinolone helps to prevent the progression of lesions to the scalp, nails, and mucosa while also reducing inflammation and pruritus in glabrous skin.⁸

Triamcinolone acetonide injections—­administered at concentrations of 5 to 40 mg/mL—directly into the lesion (0.5–1 cc per 2 cm²) are highly effective in managing recalcitrant thickened lesions such as those seen in hypertrophic LP and palmoplantar LP.⁶ This treatment is particularly beneficial when lesions are unresponsive to topical therapies. Administered every 3 to 6 weeks, these injections provide rapid symptom relief, typically within 72 hours,⁶ while also contributing to the reduction of lesion size and thickness over time. The concentration of triamcinolone acetonide should be selected based on the lesion’s severity, with higher concentrations reserved for thicker, more resistant lesions. More frequent injections may be warranted in cases in which rapid lesion reduction is necessary, while less frequent sessions may suffice for maintenance therapy. It is important to follow patients closely for adverse effects, such as signs of local skin atrophy or hypopigmentation, and to adjust the dose or frequency accordingly. To mitigate these risks, consider using the lowest effective concentration and rotating injection sites if treating multiple lesions. Additionally, combining intralesional corticosteroids with topical therapies can enhance outcomes, particularly in cases in which monotherapy is insufficient.

Patients should be monitored vigilantly for complications of LP. The risk for postinflammatory hyperpigmentation is a particular concern for patients with skin of color. Other complications of untreated LP include nail deformities and scarring alopecia.⁹ Regular and thorough follow-ups every few months to monitor scalp, mucosal, and genital involvement are essential to manage this risk effectively.

Furthermore, patient education is key. Informing patients and their caregivers about the nature of LP, the available treatment options, and the importance of ongoing follow-up can help to enhance treatment adherence and improve overall outcomes.

Diversity, equity, and inclusion (DEI) programs seek to improve dermatologic education and clinical care for an increasingly diverse patient population as well as to recruit and sustain a physician workforce that reflects the diversity of the patients they serve.^1,2 In dermatology, only 4.2% and 3.0% of practicing dermatologists self-identify as being of Hispanic and African American ethnicity, respectively, compared with 18.5% and 13.4% of the general population, respectively.³ Creating an educational system that works to meet the goals of DEI is essential to improve health outcomes and address disparities. The lack of robust DEI-related curricula during residency training may limit the ability of practicing dermatologists to provide comprehensive and culturally sensitive care. It has been shown that racial concordance between patients and physicians has a positive impact on patient satisfaction by fostering a trusting patient-physician relationship.⁴

It is the responsibility of all dermatologists to create an environment where patients from any background can feel comfortable, which can be cultivated by establishing patient-centered communication and cultural humility.⁵ These skills can be strengthened via the implementation of DEI-related curricula during residency training. Augmenting exposure of these topics during training can optimize the delivery of dermatologic care by providing residents with the tools and confidence needed to care for patients of culturally diverse backgrounds. Enhancing DEI education is crucial to not only improve the recognition and treatment of dermatologic conditions in all skin and hair types but also to minimize misconceptions, stigma, health disparities, and discrimination faced by historically marginalized communities. Creating a culture of inclusion is of paramount importance to build successful relationships with patients and colleagues of culturally diverse backgrounds.⁶

There are multiple efforts underway to increase DEI education across the field of dermatology, including the development of DEI task forces in professional organizations and societies that serve to expand DEI-related research, mentorship, and education. The American Academy of Dermatology has been leading efforts to create a curriculum focused on skin of color, particularly addressing inadequate educational training on how dermatologic conditions manifest in this population.⁷ The Skin of Color Society has similar efforts underway and is developing a speakers bureau to give leading experts a platform to lecture dermatology trainees as well as patient and community audiences on various topics in skin of color.⁸ These are just 2 of many professional dermatology organizations that are advocating for expanded education on DEI; however, consistently integrating DEI-related topics into dermatology residency training curricula remains a gap in pedagogy. To identify the DEI-related topics of greatest relevance to the dermatology resident curricula, we implemented a modified electronic Delphi (e-Delphi) consensus process to provide standardized recommendations.

Methods

A 2-round modified e-Delphi method was utilized (Figure). An initial list of potential curricular topics was formulated by an expert panel consisting of 5 dermatologists from the Association of Professors of Dermatology DEI subcommittee and the American Academy of Dermatology Diversity Task Force (A.M.A., S.B., R.V., S.D.W., J.I.S.). Initial topics were selected via several meetings among the panel members to discuss existing DEI concerns and issues that were deemed relevant due to education gaps in residency training. The list of topics was further expanded with recommendations obtained via an email sent to dermatology program directors on the Association of Professors of Dermatology listserve, which solicited voluntary participation of academic dermatologists, including program directors and dermatology residents.

There were 2 voting rounds, with each round consisting of questions scored on a Likert scale ranging from 1 to 5 (1=not essential, 2=probably not essential, 3=neutral, 4=probably essential, 5=definitely essential). The inclusion criteria to classify a topic as necessary for integration into the dermatology residency curriculum included 95% (18/19) or more of respondents rating the topic as probably essential or definitely essential; if more than 90% (17/19) of respondents rated the topic as probably essential or definitely essential and less than 10% (2/19) rated it as not essential or probably not essential, the topic was still included as part of the suggested curriculum. Topics that received ratings of probably essential or definitely essential by less than 80% (15/19) of respondents were removed from consideration. The topics that did not meet inclusion or exclusion criteria during the first round of voting were refined by the e-Delphi steering committee (V.S.E-C. and F-A.R.) based on open-ended feedback from the voting group provided at the end of the survey and subsequently passed to the second round of voting.

Results

Participants—A total of 19 respondents participated in both voting rounds, the majority (80% [15/19]) of whom were program directors or dermatologists affiliated with academia or development of DEI education; the remaining 20% [4/19]) were dermatology residents.

Open-Ended Feedback—Voting group members were able to provide open-ended feedback for each of the sets of topics after the survey, which the steering committee utilized to modify the topics as needed for the final voting round. For example, “structural racism/discrimination” was originally mentioned as a topic, but several participants suggested including specific types of racism; therefore, the wording was changed to “racism: types, definitions” to encompass broader definitions and types of racism.

Survey Results—Two genres of topics were surveyed in each voting round: clinical and nonclinical. Participants voted on a total of 61 topics, with 23 ultimately selected in the final list of consensus curricular topics. Of those, 9 were clinical and 14 nonclinical. All topics deemed necessary for inclusion in residency curricula are presented in eTables 1 and 2.

During the first round of voting, the e-Delphi panel reached a consensus to include the following 17 topics as essential to dermatology residency training (along with the percentage of voters who classified them as probably essential or definitely essential): how to mitigate bias in clinical and workplace settings (100% [40/40]); social determinants of health-related disparities in dermatology (100% [40/40]); hairstyling practices across different hair textures (100% [40/40]); definitions and examples of microaggressions (97.50% [39/40]); definition, background, and types of bias (97.50% [39/40]); manifestations of bias in the clinical setting (97.44% [38/39]); racial and ethnic disparities in dermatology (97.44% [38/39]); keloids (97.37% [37/38]); differences in dermoscopic presentations in skin of color (97.30% [36/37]); skin cancer in patients with skin of color (97.30% [36/37]); disparities due to bias (95.00% [38/40]); how to apply cultural humility and safety to patients of different cultural backgrounds (94.87% [37/40]); best practices in providing care to patients with limited English proficiency (94.87% [37/40]); hair loss in patients with textured hair (94.74% [36/38]); pseudofolliculitis barbae and acne keloidalis nuchae (94.60% [35/37]); disparities regarding people experiencing homelessness (92.31% [36/39]); and definitions and types of racism and other forms of discrimination (92.31% [36/39]). eTable 1 provides a list of suggested resources to incorporate these topics into the educational components of residency curricula. The resources provided were not part of the voting process, and they were not considered in the consensus analysis; they are included here as suggested educational catalysts.

During the second round of voting, 25 topics were evaluated. Of those, the following 6 topics were proposed to be included as essential in residency training: differences in prevalence and presentation of common inflammatory disorders (100% [29/29]); manifestations of bias in the learning environment (96.55%); antiracist action and how to decrease the effects of structural racism in clinical and educational settings (96.55% [28/29]); diversity of images in dermatology education (96.55% [28/29]); pigmentary disorders and their psychological effects (96.55% [28/29]); and LGBTQ (lesbian, gay, bisexual, transgender, and queer) dermatologic health care (96.55% [28/29]). eTable 2 includes these topics as well as suggested resources to help incorporate them into training.

Comment

This study utilized a modified e-Delphi technique to identify relevant clinical and nonclinical DEI topics that should be incorporated into dermatology residency curricula. The panel members reached a consensus for 9 clinical DEI-related topics. The respondents agreed that the topics related to skin and hair conditions in patients with skin of color as well as textured hair were crucial to residency education. Skin cancer, hair loss, pseudofolliculitis barbae, acne keloidalis nuchae, keloids, pigmentary disorders, and their varying presentations in patients with skin of color were among the recommended topics. The panel also recommended educating residents on the variable visual presentations of inflammatory conditions in skin of color. Addressing the needs of diverse patients—for example, those belonging to the LGBTQ community—also was deemed important for inclusion.

The remaining 14 chosen topics were nonclinical items addressing concepts such as bias and health care disparities as well as cultural humility and safety.⁹ Cultural humility and safety focus on developing cultural awareness by creating a safe setting for patients rather than encouraging power relationships between them and their physicians. Various topics related to racism also were recommended to be included in residency curricula, including education on implementation of antiracist action in the workplace.

Many of the nonclinical topics are intertwined; for instance, learning about health care disparities in patients with limited English proficiency allows for improved best practices in delivering care to patients from this population. The first step in overcoming bias and subsequent disparities is acknowledging how the perpetuation of bias leads to disparities after being taught tools to recognize it.

Our group’s guidance on DEI topics should help dermatology residency program leaders as they design and refine program curricula. There are multiple avenues for incorporating education on these topics, including lectures, interactive workshops, role-playing sessions, book or journal clubs, and discussion circles. Many of these topics/programs may already be included in programs’ didactic curricula, which would minimize the burden of finding space to educate on these topics. Institutional cultural change is key to ensuring truly diverse, equitable, and inclusive workplaces. Educating tomorrow’s dermatologists on these topics is a first step toward achieving that cultural change.

Limitations—A limitation of this e-Delphi survey is that only a selection of experts in this field was included. Additionally, we were concerned that the Likert scale format and the bar we set for inclusion and exclusion may have failed to adequately capture participants’ nuanced opinions. As such, participants were able to provide open-ended feedback, and suggestions for alternate wording or other changes were considered by the steering committee. Finally, inclusion recommendations identified in this survey were developed specifically for US dermatology residents.

Conclusion

In this e-Delphi consensus assessment of DEI-related topics, we recommend the inclusion of 23 topics into dermatology residency program curricula to improve medical training and the patient-physician relationship as well as to create better health outcomes. We also provide specific sample resource recommendations in eTables 1 and 2 to facilitate inclusion of these topics into residency curricula across the country.

Diversity, equity, and inclusion (DEI) programs seek to improve dermatologic education and clinical care for an increasingly diverse patient population as well as to recruit and sustain a physician workforce that reflects the diversity of the patients they serve.^1,2 In dermatology, only 4.2% and 3.0% of practicing dermatologists self-identify as being of Hispanic and African American ethnicity, respectively, compared with 18.5% and 13.4% of the general population, respectively.³ Creating an educational system that works to meet the goals of DEI is essential to improve health outcomes and address disparities. The lack of robust DEI-related curricula during residency training may limit the ability of practicing dermatologists to provide comprehensive and culturally sensitive care. It has been shown that racial concordance between patients and physicians has a positive impact on patient satisfaction by fostering a trusting patient-physician relationship.⁴

It is the responsibility of all dermatologists to create an environment where patients from any background can feel comfortable, which can be cultivated by establishing patient-centered communication and cultural humility.⁵ These skills can be strengthened via the implementation of DEI-related curricula during residency training. Augmenting exposure of these topics during training can optimize the delivery of dermatologic care by providing residents with the tools and confidence needed to care for patients of culturally diverse backgrounds. Enhancing DEI education is crucial to not only improve the recognition and treatment of dermatologic conditions in all skin and hair types but also to minimize misconceptions, stigma, health disparities, and discrimination faced by historically marginalized communities. Creating a culture of inclusion is of paramount importance to build successful relationships with patients and colleagues of culturally diverse backgrounds.⁶

There are multiple efforts underway to increase DEI education across the field of dermatology, including the development of DEI task forces in professional organizations and societies that serve to expand DEI-related research, mentorship, and education. The American Academy of Dermatology has been leading efforts to create a curriculum focused on skin of color, particularly addressing inadequate educational training on how dermatologic conditions manifest in this population.⁷ The Skin of Color Society has similar efforts underway and is developing a speakers bureau to give leading experts a platform to lecture dermatology trainees as well as patient and community audiences on various topics in skin of color.⁸ These are just 2 of many professional dermatology organizations that are advocating for expanded education on DEI; however, consistently integrating DEI-related topics into dermatology residency training curricula remains a gap in pedagogy. To identify the DEI-related topics of greatest relevance to the dermatology resident curricula, we implemented a modified electronic Delphi (e-Delphi) consensus process to provide standardized recommendations.

Methods

A 2-round modified e-Delphi method was utilized (Figure). An initial list of potential curricular topics was formulated by an expert panel consisting of 5 dermatologists from the Association of Professors of Dermatology DEI subcommittee and the American Academy of Dermatology Diversity Task Force (A.M.A., S.B., R.V., S.D.W., J.I.S.). Initial topics were selected via several meetings among the panel members to discuss existing DEI concerns and issues that were deemed relevant due to education gaps in residency training. The list of topics was further expanded with recommendations obtained via an email sent to dermatology program directors on the Association of Professors of Dermatology listserve, which solicited voluntary participation of academic dermatologists, including program directors and dermatology residents.

There were 2 voting rounds, with each round consisting of questions scored on a Likert scale ranging from 1 to 5 (1=not essential, 2=probably not essential, 3=neutral, 4=probably essential, 5=definitely essential). The inclusion criteria to classify a topic as necessary for integration into the dermatology residency curriculum included 95% (18/19) or more of respondents rating the topic as probably essential or definitely essential; if more than 90% (17/19) of respondents rated the topic as probably essential or definitely essential and less than 10% (2/19) rated it as not essential or probably not essential, the topic was still included as part of the suggested curriculum. Topics that received ratings of probably essential or definitely essential by less than 80% (15/19) of respondents were removed from consideration. The topics that did not meet inclusion or exclusion criteria during the first round of voting were refined by the e-Delphi steering committee (V.S.E-C. and F-A.R.) based on open-ended feedback from the voting group provided at the end of the survey and subsequently passed to the second round of voting.

Results

Participants—A total of 19 respondents participated in both voting rounds, the majority (80% [15/19]) of whom were program directors or dermatologists affiliated with academia or development of DEI education; the remaining 20% [4/19]) were dermatology residents.

Open-Ended Feedback—Voting group members were able to provide open-ended feedback for each of the sets of topics after the survey, which the steering committee utilized to modify the topics as needed for the final voting round. For example, “structural racism/discrimination” was originally mentioned as a topic, but several participants suggested including specific types of racism; therefore, the wording was changed to “racism: types, definitions” to encompass broader definitions and types of racism.

Survey Results—Two genres of topics were surveyed in each voting round: clinical and nonclinical. Participants voted on a total of 61 topics, with 23 ultimately selected in the final list of consensus curricular topics. Of those, 9 were clinical and 14 nonclinical. All topics deemed necessary for inclusion in residency curricula are presented in eTables 1 and 2.

During the first round of voting, the e-Delphi panel reached a consensus to include the following 17 topics as essential to dermatology residency training (along with the percentage of voters who classified them as probably essential or definitely essential): how to mitigate bias in clinical and workplace settings (100% [40/40]); social determinants of health-related disparities in dermatology (100% [40/40]); hairstyling practices across different hair textures (100% [40/40]); definitions and examples of microaggressions (97.50% [39/40]); definition, background, and types of bias (97.50% [39/40]); manifestations of bias in the clinical setting (97.44% [38/39]); racial and ethnic disparities in dermatology (97.44% [38/39]); keloids (97.37% [37/38]); differences in dermoscopic presentations in skin of color (97.30% [36/37]); skin cancer in patients with skin of color (97.30% [36/37]); disparities due to bias (95.00% [38/40]); how to apply cultural humility and safety to patients of different cultural backgrounds (94.87% [37/40]); best practices in providing care to patients with limited English proficiency (94.87% [37/40]); hair loss in patients with textured hair (94.74% [36/38]); pseudofolliculitis barbae and acne keloidalis nuchae (94.60% [35/37]); disparities regarding people experiencing homelessness (92.31% [36/39]); and definitions and types of racism and other forms of discrimination (92.31% [36/39]). eTable 1 provides a list of suggested resources to incorporate these topics into the educational components of residency curricula. The resources provided were not part of the voting process, and they were not considered in the consensus analysis; they are included here as suggested educational catalysts.

During the second round of voting, 25 topics were evaluated. Of those, the following 6 topics were proposed to be included as essential in residency training: differences in prevalence and presentation of common inflammatory disorders (100% [29/29]); manifestations of bias in the learning environment (96.55%); antiracist action and how to decrease the effects of structural racism in clinical and educational settings (96.55% [28/29]); diversity of images in dermatology education (96.55% [28/29]); pigmentary disorders and their psychological effects (96.55% [28/29]); and LGBTQ (lesbian, gay, bisexual, transgender, and queer) dermatologic health care (96.55% [28/29]). eTable 2 includes these topics as well as suggested resources to help incorporate them into training.

Comment

This study utilized a modified e-Delphi technique to identify relevant clinical and nonclinical DEI topics that should be incorporated into dermatology residency curricula. The panel members reached a consensus for 9 clinical DEI-related topics. The respondents agreed that the topics related to skin and hair conditions in patients with skin of color as well as textured hair were crucial to residency education. Skin cancer, hair loss, pseudofolliculitis barbae, acne keloidalis nuchae, keloids, pigmentary disorders, and their varying presentations in patients with skin of color were among the recommended topics. The panel also recommended educating residents on the variable visual presentations of inflammatory conditions in skin of color. Addressing the needs of diverse patients—for example, those belonging to the LGBTQ community—also was deemed important for inclusion.

The remaining 14 chosen topics were nonclinical items addressing concepts such as bias and health care disparities as well as cultural humility and safety.⁹ Cultural humility and safety focus on developing cultural awareness by creating a safe setting for patients rather than encouraging power relationships between them and their physicians. Various topics related to racism also were recommended to be included in residency curricula, including education on implementation of antiracist action in the workplace.

Many of the nonclinical topics are intertwined; for instance, learning about health care disparities in patients with limited English proficiency allows for improved best practices in delivering care to patients from this population. The first step in overcoming bias and subsequent disparities is acknowledging how the perpetuation of bias leads to disparities after being taught tools to recognize it.

Our group’s guidance on DEI topics should help dermatology residency program leaders as they design and refine program curricula. There are multiple avenues for incorporating education on these topics, including lectures, interactive workshops, role-playing sessions, book or journal clubs, and discussion circles. Many of these topics/programs may already be included in programs’ didactic curricula, which would minimize the burden of finding space to educate on these topics. Institutional cultural change is key to ensuring truly diverse, equitable, and inclusive workplaces. Educating tomorrow’s dermatologists on these topics is a first step toward achieving that cultural change.

Limitations—A limitation of this e-Delphi survey is that only a selection of experts in this field was included. Additionally, we were concerned that the Likert scale format and the bar we set for inclusion and exclusion may have failed to adequately capture participants’ nuanced opinions. As such, participants were able to provide open-ended feedback, and suggestions for alternate wording or other changes were considered by the steering committee. Finally, inclusion recommendations identified in this survey were developed specifically for US dermatology residents.

Conclusion

In this e-Delphi consensus assessment of DEI-related topics, we recommend the inclusion of 23 topics into dermatology residency program curricula to improve medical training and the patient-physician relationship as well as to create better health outcomes. We also provide specific sample resource recommendations in eTables 1 and 2 to facilitate inclusion of these topics into residency curricula across the country.

Diversity, equity, and inclusion (DEI) programs seek to improve dermatologic education and clinical care for an increasingly diverse patient population as well as to recruit and sustain a physician workforce that reflects the diversity of the patients they serve.^1,2 In dermatology, only 4.2% and 3.0% of practicing dermatologists self-identify as being of Hispanic and African American ethnicity, respectively, compared with 18.5% and 13.4% of the general population, respectively.³ Creating an educational system that works to meet the goals of DEI is essential to improve health outcomes and address disparities. The lack of robust DEI-related curricula during residency training may limit the ability of practicing dermatologists to provide comprehensive and culturally sensitive care. It has been shown that racial concordance between patients and physicians has a positive impact on patient satisfaction by fostering a trusting patient-physician relationship.⁴

It is the responsibility of all dermatologists to create an environment where patients from any background can feel comfortable, which can be cultivated by establishing patient-centered communication and cultural humility.⁵ These skills can be strengthened via the implementation of DEI-related curricula during residency training. Augmenting exposure of these topics during training can optimize the delivery of dermatologic care by providing residents with the tools and confidence needed to care for patients of culturally diverse backgrounds. Enhancing DEI education is crucial to not only improve the recognition and treatment of dermatologic conditions in all skin and hair types but also to minimize misconceptions, stigma, health disparities, and discrimination faced by historically marginalized communities. Creating a culture of inclusion is of paramount importance to build successful relationships with patients and colleagues of culturally diverse backgrounds.⁶

There are multiple efforts underway to increase DEI education across the field of dermatology, including the development of DEI task forces in professional organizations and societies that serve to expand DEI-related research, mentorship, and education. The American Academy of Dermatology has been leading efforts to create a curriculum focused on skin of color, particularly addressing inadequate educational training on how dermatologic conditions manifest in this population.⁷ The Skin of Color Society has similar efforts underway and is developing a speakers bureau to give leading experts a platform to lecture dermatology trainees as well as patient and community audiences on various topics in skin of color.⁸ These are just 2 of many professional dermatology organizations that are advocating for expanded education on DEI; however, consistently integrating DEI-related topics into dermatology residency training curricula remains a gap in pedagogy. To identify the DEI-related topics of greatest relevance to the dermatology resident curricula, we implemented a modified electronic Delphi (e-Delphi) consensus process to provide standardized recommendations.

Methods

A 2-round modified e-Delphi method was utilized (Figure). An initial list of potential curricular topics was formulated by an expert panel consisting of 5 dermatologists from the Association of Professors of Dermatology DEI subcommittee and the American Academy of Dermatology Diversity Task Force (A.M.A., S.B., R.V., S.D.W., J.I.S.). Initial topics were selected via several meetings among the panel members to discuss existing DEI concerns and issues that were deemed relevant due to education gaps in residency training. The list of topics was further expanded with recommendations obtained via an email sent to dermatology program directors on the Association of Professors of Dermatology listserve, which solicited voluntary participation of academic dermatologists, including program directors and dermatology residents.

There were 2 voting rounds, with each round consisting of questions scored on a Likert scale ranging from 1 to 5 (1=not essential, 2=probably not essential, 3=neutral, 4=probably essential, 5=definitely essential). The inclusion criteria to classify a topic as necessary for integration into the dermatology residency curriculum included 95% (18/19) or more of respondents rating the topic as probably essential or definitely essential; if more than 90% (17/19) of respondents rated the topic as probably essential or definitely essential and less than 10% (2/19) rated it as not essential or probably not essential, the topic was still included as part of the suggested curriculum. Topics that received ratings of probably essential or definitely essential by less than 80% (15/19) of respondents were removed from consideration. The topics that did not meet inclusion or exclusion criteria during the first round of voting were refined by the e-Delphi steering committee (V.S.E-C. and F-A.R.) based on open-ended feedback from the voting group provided at the end of the survey and subsequently passed to the second round of voting.

Results

Participants—A total of 19 respondents participated in both voting rounds, the majority (80% [15/19]) of whom were program directors or dermatologists affiliated with academia or development of DEI education; the remaining 20% [4/19]) were dermatology residents.

Open-Ended Feedback—Voting group members were able to provide open-ended feedback for each of the sets of topics after the survey, which the steering committee utilized to modify the topics as needed for the final voting round. For example, “structural racism/discrimination” was originally mentioned as a topic, but several participants suggested including specific types of racism; therefore, the wording was changed to “racism: types, definitions” to encompass broader definitions and types of racism.

Survey Results—Two genres of topics were surveyed in each voting round: clinical and nonclinical. Participants voted on a total of 61 topics, with 23 ultimately selected in the final list of consensus curricular topics. Of those, 9 were clinical and 14 nonclinical. All topics deemed necessary for inclusion in residency curricula are presented in eTables 1 and 2.

During the first round of voting, the e-Delphi panel reached a consensus to include the following 17 topics as essential to dermatology residency training (along with the percentage of voters who classified them as probably essential or definitely essential): how to mitigate bias in clinical and workplace settings (100% [40/40]); social determinants of health-related disparities in dermatology (100% [40/40]); hairstyling practices across different hair textures (100% [40/40]); definitions and examples of microaggressions (97.50% [39/40]); definition, background, and types of bias (97.50% [39/40]); manifestations of bias in the clinical setting (97.44% [38/39]); racial and ethnic disparities in dermatology (97.44% [38/39]); keloids (97.37% [37/38]); differences in dermoscopic presentations in skin of color (97.30% [36/37]); skin cancer in patients with skin of color (97.30% [36/37]); disparities due to bias (95.00% [38/40]); how to apply cultural humility and safety to patients of different cultural backgrounds (94.87% [37/40]); best practices in providing care to patients with limited English proficiency (94.87% [37/40]); hair loss in patients with textured hair (94.74% [36/38]); pseudofolliculitis barbae and acne keloidalis nuchae (94.60% [35/37]); disparities regarding people experiencing homelessness (92.31% [36/39]); and definitions and types of racism and other forms of discrimination (92.31% [36/39]). eTable 1 provides a list of suggested resources to incorporate these topics into the educational components of residency curricula. The resources provided were not part of the voting process, and they were not considered in the consensus analysis; they are included here as suggested educational catalysts.

During the second round of voting, 25 topics were evaluated. Of those, the following 6 topics were proposed to be included as essential in residency training: differences in prevalence and presentation of common inflammatory disorders (100% [29/29]); manifestations of bias in the learning environment (96.55%); antiracist action and how to decrease the effects of structural racism in clinical and educational settings (96.55% [28/29]); diversity of images in dermatology education (96.55% [28/29]); pigmentary disorders and their psychological effects (96.55% [28/29]); and LGBTQ (lesbian, gay, bisexual, transgender, and queer) dermatologic health care (96.55% [28/29]). eTable 2 includes these topics as well as suggested resources to help incorporate them into training.

Comment

This study utilized a modified e-Delphi technique to identify relevant clinical and nonclinical DEI topics that should be incorporated into dermatology residency curricula. The panel members reached a consensus for 9 clinical DEI-related topics. The respondents agreed that the topics related to skin and hair conditions in patients with skin of color as well as textured hair were crucial to residency education. Skin cancer, hair loss, pseudofolliculitis barbae, acne keloidalis nuchae, keloids, pigmentary disorders, and their varying presentations in patients with skin of color were among the recommended topics. The panel also recommended educating residents on the variable visual presentations of inflammatory conditions in skin of color. Addressing the needs of diverse patients—for example, those belonging to the LGBTQ community—also was deemed important for inclusion.

The remaining 14 chosen topics were nonclinical items addressing concepts such as bias and health care disparities as well as cultural humility and safety.⁹ Cultural humility and safety focus on developing cultural awareness by creating a safe setting for patients rather than encouraging power relationships between them and their physicians. Various topics related to racism also were recommended to be included in residency curricula, including education on implementation of antiracist action in the workplace.

Many of the nonclinical topics are intertwined; for instance, learning about health care disparities in patients with limited English proficiency allows for improved best practices in delivering care to patients from this population. The first step in overcoming bias and subsequent disparities is acknowledging how the perpetuation of bias leads to disparities after being taught tools to recognize it.

Our group’s guidance on DEI topics should help dermatology residency program leaders as they design and refine program curricula. There are multiple avenues for incorporating education on these topics, including lectures, interactive workshops, role-playing sessions, book or journal clubs, and discussion circles. Many of these topics/programs may already be included in programs’ didactic curricula, which would minimize the burden of finding space to educate on these topics. Institutional cultural change is key to ensuring truly diverse, equitable, and inclusive workplaces. Educating tomorrow’s dermatologists on these topics is a first step toward achieving that cultural change.

Limitations—A limitation of this e-Delphi survey is that only a selection of experts in this field was included. Additionally, we were concerned that the Likert scale format and the bar we set for inclusion and exclusion may have failed to adequately capture participants’ nuanced opinions. As such, participants were able to provide open-ended feedback, and suggestions for alternate wording or other changes were considered by the steering committee. Finally, inclusion recommendations identified in this survey were developed specifically for US dermatology residents.

Conclusion

In this e-Delphi consensus assessment of DEI-related topics, we recommend the inclusion of 23 topics into dermatology residency program curricula to improve medical training and the patient-physician relationship as well as to create better health outcomes. We also provide specific sample resource recommendations in eTables 1 and 2 to facilitate inclusion of these topics into residency curricula across the country.

TOPLINE:

Metformin significantly improved symptoms and resulted in hair regrowth in Black women with treatment-refractory central centrifugal cicatricial alopecia (CCCA), in a retrospective case series.

METHODOLOGY:

• Researchers conducted a case series involving 12 Black women in their 30s, 40s, and 50s, with biopsy-confirmed, treatment-refractory CCCA, a chronic inflammatory hair disorder characterized by permanent hair loss, from the Johns Hopkins University alopecia clinic.
• Participants received CCCA treatment for at least 6 months and had stagnant or worsening symptoms before oral extended-release metformin (500 mg daily) was added to treatment. (Treatments included topical clobetasol, compounded minoxidil, and platelet-rich plasma injections.)
• Scalp biopsies were collected from four patients before and after metformin treatment to evaluate gene expression changes.
• Changes in clinical symptoms were assessed, including pruritus, inflammation, pain, scalp resistance, and hair regrowth, following initiation of metformin treatment.

TAKEAWAY:

• Metformin led to significant clinical improvement in eight patients, which included reductions in scalp pain, scalp resistance, pruritus, and inflammation. However, two patients experienced worsening symptoms.
• Six patients showed clinical evidence of hair regrowth after at least 6 months of metformin treatment with one experiencing hair loss again 3 months after discontinuing treatment.
• Transcriptomic analysis revealed 34 upregulated genes, which included upregulated of 23 hair keratin-associated proteins, and pathways related to keratinization, epidermis development, and the hair cycle. In addition, eight genes were downregulated, with pathways that included those associated with extracellular matrix organization, collagen fibril organization, and collagen metabolism.
• Gene set variation analysis showed reduced expression of T helper 17 cell and epithelial-mesenchymal transition pathways and elevated adenosine monophosphate kinase signaling and keratin-associated proteins after treatment with metformin.

IN PRACTICE:

“Metformin’s ability to concomitantly target fibrosis and inflammation provides a plausible mechanism for its therapeutic effects in CCCA and other fibrosing alopecia disorders,” the authors concluded. But, they added, “larger prospective, placebo-controlled randomized clinical trials are needed to rigorously evaluate metformin’s efficacy and optimal dosing for treatment of cicatricial alopecias.”

SOURCE:

The study was led by Aaron Bao, Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, and was published online on September 4 in JAMA Dermatology.

LIMITATIONS:

A small sample size, retrospective design, lack of a placebo control group, and the single-center setting limited the generalizability of the study findings. In addition, the absence of a validated activity or severity scale for CCCA and the single posttreatment sampling limit the assessment and comparison of clinical symptoms and transcriptomic changes.

DISCLOSURES:

The study was supported by the American Academy of Dermatology. One author reported several ties with pharmaceutical companies, a pending patent, and authorship for the UpToDate section on CCCA.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Metformin significantly improved symptoms and resulted in hair regrowth in Black women with treatment-refractory central centrifugal cicatricial alopecia (CCCA), in a retrospective case series.

METHODOLOGY:

• Researchers conducted a case series involving 12 Black women in their 30s, 40s, and 50s, with biopsy-confirmed, treatment-refractory CCCA, a chronic inflammatory hair disorder characterized by permanent hair loss, from the Johns Hopkins University alopecia clinic.
• Participants received CCCA treatment for at least 6 months and had stagnant or worsening symptoms before oral extended-release metformin (500 mg daily) was added to treatment. (Treatments included topical clobetasol, compounded minoxidil, and platelet-rich plasma injections.)
• Scalp biopsies were collected from four patients before and after metformin treatment to evaluate gene expression changes.
• Changes in clinical symptoms were assessed, including pruritus, inflammation, pain, scalp resistance, and hair regrowth, following initiation of metformin treatment.

TAKEAWAY:

• Metformin led to significant clinical improvement in eight patients, which included reductions in scalp pain, scalp resistance, pruritus, and inflammation. However, two patients experienced worsening symptoms.
• Six patients showed clinical evidence of hair regrowth after at least 6 months of metformin treatment with one experiencing hair loss again 3 months after discontinuing treatment.
• Transcriptomic analysis revealed 34 upregulated genes, which included upregulated of 23 hair keratin-associated proteins, and pathways related to keratinization, epidermis development, and the hair cycle. In addition, eight genes were downregulated, with pathways that included those associated with extracellular matrix organization, collagen fibril organization, and collagen metabolism.
• Gene set variation analysis showed reduced expression of T helper 17 cell and epithelial-mesenchymal transition pathways and elevated adenosine monophosphate kinase signaling and keratin-associated proteins after treatment with metformin.

IN PRACTICE:

“Metformin’s ability to concomitantly target fibrosis and inflammation provides a plausible mechanism for its therapeutic effects in CCCA and other fibrosing alopecia disorders,” the authors concluded. But, they added, “larger prospective, placebo-controlled randomized clinical trials are needed to rigorously evaluate metformin’s efficacy and optimal dosing for treatment of cicatricial alopecias.”

SOURCE:

The study was led by Aaron Bao, Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, and was published online on September 4 in JAMA Dermatology.

LIMITATIONS:

A small sample size, retrospective design, lack of a placebo control group, and the single-center setting limited the generalizability of the study findings. In addition, the absence of a validated activity or severity scale for CCCA and the single posttreatment sampling limit the assessment and comparison of clinical symptoms and transcriptomic changes.

DISCLOSURES:

The study was supported by the American Academy of Dermatology. One author reported several ties with pharmaceutical companies, a pending patent, and authorship for the UpToDate section on CCCA.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Metformin significantly improved symptoms and resulted in hair regrowth in Black women with treatment-refractory central centrifugal cicatricial alopecia (CCCA), in a retrospective case series.

METHODOLOGY:

• Researchers conducted a case series involving 12 Black women in their 30s, 40s, and 50s, with biopsy-confirmed, treatment-refractory CCCA, a chronic inflammatory hair disorder characterized by permanent hair loss, from the Johns Hopkins University alopecia clinic.
• Participants received CCCA treatment for at least 6 months and had stagnant or worsening symptoms before oral extended-release metformin (500 mg daily) was added to treatment. (Treatments included topical clobetasol, compounded minoxidil, and platelet-rich plasma injections.)
• Scalp biopsies were collected from four patients before and after metformin treatment to evaluate gene expression changes.
• Changes in clinical symptoms were assessed, including pruritus, inflammation, pain, scalp resistance, and hair regrowth, following initiation of metformin treatment.

TAKEAWAY:

• Metformin led to significant clinical improvement in eight patients, which included reductions in scalp pain, scalp resistance, pruritus, and inflammation. However, two patients experienced worsening symptoms.
• Six patients showed clinical evidence of hair regrowth after at least 6 months of metformin treatment with one experiencing hair loss again 3 months after discontinuing treatment.
• Transcriptomic analysis revealed 34 upregulated genes, which included upregulated of 23 hair keratin-associated proteins, and pathways related to keratinization, epidermis development, and the hair cycle. In addition, eight genes were downregulated, with pathways that included those associated with extracellular matrix organization, collagen fibril organization, and collagen metabolism.
• Gene set variation analysis showed reduced expression of T helper 17 cell and epithelial-mesenchymal transition pathways and elevated adenosine monophosphate kinase signaling and keratin-associated proteins after treatment with metformin.

IN PRACTICE:

“Metformin’s ability to concomitantly target fibrosis and inflammation provides a plausible mechanism for its therapeutic effects in CCCA and other fibrosing alopecia disorders,” the authors concluded. But, they added, “larger prospective, placebo-controlled randomized clinical trials are needed to rigorously evaluate metformin’s efficacy and optimal dosing for treatment of cicatricial alopecias.”

SOURCE:

The study was led by Aaron Bao, Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, and was published online on September 4 in JAMA Dermatology.

LIMITATIONS:

A small sample size, retrospective design, lack of a placebo control group, and the single-center setting limited the generalizability of the study findings. In addition, the absence of a validated activity or severity scale for CCCA and the single posttreatment sampling limit the assessment and comparison of clinical symptoms and transcriptomic changes.

DISCLOSURES:

The study was supported by the American Academy of Dermatology. One author reported several ties with pharmaceutical companies, a pending patent, and authorship for the UpToDate section on CCCA.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Hormone-modulating therapy for breast cancer may protect older women from Alzheimer’s disease and related dementias, although the protective effect varies by age and race, with the greatest benefit seen in younger Black women.

METHODOLOGY:

• Hormone-modulating therapy is widely used to treat hormone receptor–positive breast cancer, but the cognitive effects of the treatment, including a potential link to dementia, remain unclear.
• To investigate, researchers used the SEER-Medicare linked database to identify women aged 65 years or older with breast cancer who did and did not receive hormone-modulating therapy within 3 years following their diagnosis.
• The researchers excluded women with preexisting Alzheimer’s disease/dementia diagnoses or those who had received hormone-modulating therapy before their breast cancer diagnosis.
• Analyses were adjusted for demographic, sociocultural, and clinical variables, and subgroup analyses evaluated the impact of age, race, and type of hormone-modulating therapy on Alzheimer’s disease/dementia risk.

TAKEAWAY:

• Among the 18,808 women included in the analysis, 66% received hormone-modulating therapy and 34% did not. During the mean follow-up of 12 years, 24% of hormone-modulating therapy users and 28% of nonusers developed Alzheimer’s disease/dementia.
• Overall, hormone-modulating therapy use (vs nonuse) was associated with a significant 7% lower risk for Alzheimer’s disease/dementia (hazard ratio [HR], 0.93; P = .005), with notable age and racial differences.
• Hormone-modulating therapy use was associated with a 24% lower risk for Alzheimer’s disease/dementia in Black women aged 65-74 years (HR, 0.76), but that protective effect decreased to 19% in Black women aged 75 years or older (HR, 0.81). White women aged 65-74 years who received hormone-modulating therapy (vs those who did not) had an 11% lower risk for Alzheimer’s disease/dementia (HR, 0.89), but the association disappeared among those aged 75 years or older (HR, 0.96; 95% CI, 0.90-1.02). Other races demonstrated no significant association between hormone-modulating therapy use and Alzheimer’s disease/dementia.
• Overall, the use of an aromatase inhibitor or a selective estrogen receptor modulator was associated with a significantly lower risk for Alzheimer’s disease/dementia (HR, 0.93 and HR, 0.89, respectively).

IN PRACTICE:

Overall, the retrospective study found that “hormone therapy was associated with protection against [Alzheimer’s/dementia] in women aged 65 years or older with newly diagnosed breast cancer,” with the decrease in risk relatively greater for Black women and women younger than 75 years, the authors concluded.

“The results highlight the critical need for personalized breast cancer treatment plans that are tailored to the individual characteristics of each patient, particularly given the significantly higher likelihood (two to three times more) of Black women developing [Alzheimer’s/dementia], compared with their White counterparts,” the researchers added.
 

SOURCE:

The study, with first author Chao Cai, PhD, Department of Clinical Pharmacy and Outcomes Sciences, University of South Carolina, Columbia, was published online on July 16 in JAMA Network Open.

LIMITATIONS:

The study included only women aged 65 years or older, limiting generalizability to younger women. The dataset lacked genetic information and laboratory data related to dementia. The duration of hormone-modulating therapy use beyond 3 years and specific formulations were not assessed. Potential confounders such as variations in chemotherapy, radiation, and surgery were not fully addressed.

DISCLOSURES:

Support for the study was provided by the National Institutes of Health; Carolina Center on Alzheimer’s Disease and Minority Research pilot project; and the Dean’s Faculty Advancement Fund, University of Pittsburgh, Pennsylvania. The authors reported no relevant disclosures.

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

TOPLINE:

Hormone-modulating therapy for breast cancer may protect older women from Alzheimer’s disease and related dementias, although the protective effect varies by age and race, with the greatest benefit seen in younger Black women.

METHODOLOGY:

• Hormone-modulating therapy is widely used to treat hormone receptor–positive breast cancer, but the cognitive effects of the treatment, including a potential link to dementia, remain unclear.
• To investigate, researchers used the SEER-Medicare linked database to identify women aged 65 years or older with breast cancer who did and did not receive hormone-modulating therapy within 3 years following their diagnosis.
• The researchers excluded women with preexisting Alzheimer’s disease/dementia diagnoses or those who had received hormone-modulating therapy before their breast cancer diagnosis.
• Analyses were adjusted for demographic, sociocultural, and clinical variables, and subgroup analyses evaluated the impact of age, race, and type of hormone-modulating therapy on Alzheimer’s disease/dementia risk.

TAKEAWAY:

• Among the 18,808 women included in the analysis, 66% received hormone-modulating therapy and 34% did not. During the mean follow-up of 12 years, 24% of hormone-modulating therapy users and 28% of nonusers developed Alzheimer’s disease/dementia.
• Overall, hormone-modulating therapy use (vs nonuse) was associated with a significant 7% lower risk for Alzheimer’s disease/dementia (hazard ratio [HR], 0.93; P = .005), with notable age and racial differences.
• Hormone-modulating therapy use was associated with a 24% lower risk for Alzheimer’s disease/dementia in Black women aged 65-74 years (HR, 0.76), but that protective effect decreased to 19% in Black women aged 75 years or older (HR, 0.81). White women aged 65-74 years who received hormone-modulating therapy (vs those who did not) had an 11% lower risk for Alzheimer’s disease/dementia (HR, 0.89), but the association disappeared among those aged 75 years or older (HR, 0.96; 95% CI, 0.90-1.02). Other races demonstrated no significant association between hormone-modulating therapy use and Alzheimer’s disease/dementia.
• Overall, the use of an aromatase inhibitor or a selective estrogen receptor modulator was associated with a significantly lower risk for Alzheimer’s disease/dementia (HR, 0.93 and HR, 0.89, respectively).

IN PRACTICE:

Overall, the retrospective study found that “hormone therapy was associated with protection against [Alzheimer’s/dementia] in women aged 65 years or older with newly diagnosed breast cancer,” with the decrease in risk relatively greater for Black women and women younger than 75 years, the authors concluded.

“The results highlight the critical need for personalized breast cancer treatment plans that are tailored to the individual characteristics of each patient, particularly given the significantly higher likelihood (two to three times more) of Black women developing [Alzheimer’s/dementia], compared with their White counterparts,” the researchers added.
 

SOURCE:

The study, with first author Chao Cai, PhD, Department of Clinical Pharmacy and Outcomes Sciences, University of South Carolina, Columbia, was published online on July 16 in JAMA Network Open.

LIMITATIONS:

The study included only women aged 65 years or older, limiting generalizability to younger women. The dataset lacked genetic information and laboratory data related to dementia. The duration of hormone-modulating therapy use beyond 3 years and specific formulations were not assessed. Potential confounders such as variations in chemotherapy, radiation, and surgery were not fully addressed.

DISCLOSURES:

Support for the study was provided by the National Institutes of Health; Carolina Center on Alzheimer’s Disease and Minority Research pilot project; and the Dean’s Faculty Advancement Fund, University of Pittsburgh, Pennsylvania. The authors reported no relevant disclosures.

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

TOPLINE:

Hormone-modulating therapy for breast cancer may protect older women from Alzheimer’s disease and related dementias, although the protective effect varies by age and race, with the greatest benefit seen in younger Black women.

METHODOLOGY:

• Hormone-modulating therapy is widely used to treat hormone receptor–positive breast cancer, but the cognitive effects of the treatment, including a potential link to dementia, remain unclear.
• To investigate, researchers used the SEER-Medicare linked database to identify women aged 65 years or older with breast cancer who did and did not receive hormone-modulating therapy within 3 years following their diagnosis.
• The researchers excluded women with preexisting Alzheimer’s disease/dementia diagnoses or those who had received hormone-modulating therapy before their breast cancer diagnosis.
• Analyses were adjusted for demographic, sociocultural, and clinical variables, and subgroup analyses evaluated the impact of age, race, and type of hormone-modulating therapy on Alzheimer’s disease/dementia risk.

TAKEAWAY:

• Among the 18,808 women included in the analysis, 66% received hormone-modulating therapy and 34% did not. During the mean follow-up of 12 years, 24% of hormone-modulating therapy users and 28% of nonusers developed Alzheimer’s disease/dementia.
• Overall, hormone-modulating therapy use (vs nonuse) was associated with a significant 7% lower risk for Alzheimer’s disease/dementia (hazard ratio [HR], 0.93; P = .005), with notable age and racial differences.
• Hormone-modulating therapy use was associated with a 24% lower risk for Alzheimer’s disease/dementia in Black women aged 65-74 years (HR, 0.76), but that protective effect decreased to 19% in Black women aged 75 years or older (HR, 0.81). White women aged 65-74 years who received hormone-modulating therapy (vs those who did not) had an 11% lower risk for Alzheimer’s disease/dementia (HR, 0.89), but the association disappeared among those aged 75 years or older (HR, 0.96; 95% CI, 0.90-1.02). Other races demonstrated no significant association between hormone-modulating therapy use and Alzheimer’s disease/dementia.
• Overall, the use of an aromatase inhibitor or a selective estrogen receptor modulator was associated with a significantly lower risk for Alzheimer’s disease/dementia (HR, 0.93 and HR, 0.89, respectively).

IN PRACTICE:

Overall, the retrospective study found that “hormone therapy was associated with protection against [Alzheimer’s/dementia] in women aged 65 years or older with newly diagnosed breast cancer,” with the decrease in risk relatively greater for Black women and women younger than 75 years, the authors concluded.

“The results highlight the critical need for personalized breast cancer treatment plans that are tailored to the individual characteristics of each patient, particularly given the significantly higher likelihood (two to three times more) of Black women developing [Alzheimer’s/dementia], compared with their White counterparts,” the researchers added.
 

SOURCE:

The study, with first author Chao Cai, PhD, Department of Clinical Pharmacy and Outcomes Sciences, University of South Carolina, Columbia, was published online on July 16 in JAMA Network Open.

LIMITATIONS:

The study included only women aged 65 years or older, limiting generalizability to younger women. The dataset lacked genetic information and laboratory data related to dementia. The duration of hormone-modulating therapy use beyond 3 years and specific formulations were not assessed. Potential confounders such as variations in chemotherapy, radiation, and surgery were not fully addressed.

DISCLOSURES:

Support for the study was provided by the National Institutes of Health; Carolina Center on Alzheimer’s Disease and Minority Research pilot project; and the Dean’s Faculty Advancement Fund, University of Pittsburgh, Pennsylvania. The authors reported no relevant disclosures.

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

Financial relationships between physicians and industry are prevalent and complex and may have implications for patient care. A 2007 study reported that 94% of 3167 physicians surveyed had established some form of paid relationship with companies in the pharmaceutical industry.¹ To facilitate increased transparency around these relationships, lawmakers passed the Physician Payments Sunshine Act in 2010, which requires pharmaceutical companies and device manufacturers to report all payments made to physicians.² Mandatory disclosures include meals, honoraria, travel expenses, grants, and ownership or investment interests greater than $10. The information is displayed publicly in the Open Payments database (OPD)(https://openpayments-data.cms.gov/), a platform run by the Centers for Medicare and Medicaid Services.

The OPD allows for in-depth analyses of industry payments made to physicians. Many medical specialties—including orthopedics,^3-5 plastic surgery,^6,7 ophthalmology,⁸ and gastroenterology⁹—have published extensive literature characterizing the nature of these payments and disparities in the distribution of payments based on sex, geographic distribution, and other factors. After the first full year of OPD data collection for dermatology in 2014, Feng et al¹⁰ examined the number, amount, and nature of industry payments to dermatologists, as well as their geographic distribution for that year. As a follow-up to this initial research, Schlager et al¹¹ characterized payments made to dermatologists for the year 2016 and found an increase in the total payments, mean payments, and number of dermatologists receiving payments compared with the 2014 data.

Our study aimed to characterize the last 5 years of available OPD data—from January 1, 2017, to December 31, 2021—to further explore trends in industry payments made to dermatologists. In particular, we examined the effects of the COVID-19 pandemic on payments as well as sex disparities and the distribution of industry payments.

Methods

We performed a retrospective analysis of the OPD for the general payment datasets from January 1, 2017, to December 31, 2021. The results were filtered to include only payments made to dermatologists, excluding physicians from other specialties, physician assistants, and other types of practitioners. Data for each physician were grouped by National Provider Identifier (NPI) for providers included in the set, allowing for analysis at the individual level. Data on sex were extracted from the National Plan & Provider Enumeration System’s monthly data dissemination for NPIs for July 2023 (when the study was conducted) and were joined to the OPD data using the NPI number reported for each physician. All data were extracted, transformed, and analyzed using R software (version 4.2.1). Figures and visualizations were produced using Microsoft Excel 2016.

Results

In 2017, a total of 358,884 payments were made by industry to dermatologists, accounting for nearly $58.0 million. The mean total value of payments received per dermatologist was $5231.74, and the mean payment amount was $161.49. In 2018, the total number of payments increased year-over-year by 5.5% (378,509 payments), the total value of payments received increased by 7.5% (approximately $62.3 million), and the mean total value of payments received per dermatologist increased by 5.3% ($5508.98). In 2019, the total number of payments increased by 3.0% (389,670 total payments), the total value of payments recieved increased by 13.2% (approximately $70.5 million), and the mean total value of payments received per dermatologist increased by 11.3% ($6133.45). All of these values decreased in 2020, likely due to COVID-19–related restrictions on travel and meetings (total number of payments, 208,470 [−46.5%]; total value of payments received, approximately $37.5 million [−46.9%], mean total value of payments received per dermatologist, $3757.27 [−38.7%]), but the mean payment amount remained stable at $179.47. In 2021, the total number of payments (295,808 [+41.9%]), total value of payments received (approximately $50.3 million [+34.4%]), and mean total value of payments received per dermatologist ($4707.88 [+25.3%]) all rebounded, but not to pre-2020 levels (Table 1). When looking at the geographic distribution of payments, the top 5 states receiving the highest total value of payments during the study period included California ($41.51 million), New York ($32.26 million), Florida ($21.38 million), Texas ($19.93 million), and Pennsylvania ($11.69 million).

For each year from 2017 to 2021, more than 80% of payments made to dermatologists were less than $50. The majority (60.7%–75.8%) were in the $10 to $50 range. Between 4% and 5% of payments were more than $1000 for each year. Fewer than 10% of dermatologists received more than $5000 in total payments per year. Most dermatologists (33.3%–36.9%) received $100 to $500 per year. The distribution of payments stratified by number of payments made by amount and payment amount per dermatologist is further delineated in Table 2.

Comment

Benefits of Physician Relationships With Industry—The Physician Payments Sunshine Act increased transparency of industry payments to physicians by creating the OPD through which these relationships can be reported.¹² The effects of these relationships on treatment practices have been the subject of many studies in recent years. Some have suggested that industry ties may impact prescription patterns of endorsed medications.¹³ It also has been reported that the chance of a research study identifying a positive outcome for a particular treatment is higher when the study is funded by a pharmaceutical company compared to other sponsors.¹⁴ On the other hand, some researchers have argued that, when established and maintained in an ethical manner, industry-physician relationships may help practitioners stay updated on the newest treatment paradigms and benefit patient care.¹⁵ Industry relationships may help drive innovation of new products with direct input from frontline physicians who take care of the patients these products aim to help.

Limitations of the OPD—Critics of the OPD have argued that the reported data lack sufficient context and are not easily interpretable by most patients.¹⁶ In addition, many patients might not know about the existence of the database. Indeed, one national survey-based study showed that only 12% of 3542 respondents knew that this information was publicly available, and only 5% knew whether their own physician had received industry payments.¹⁷

Increased Payments From Industry—Our analysis builds on previously reported data in dermatology from 2014 to 2016.^10,11 We found that the trends of increasing numbers and dollar amounts of payments made by industry to dermatologists continued from 2017 to 2019, which may reflect the intended effects of the Physician Payments Sunshine Act, as more payments are being reported in a transparent manner. It also shows that relationships between industry and dermatologists have become more commonplace over time.

It is important to consider these trends in the context of overall Medicare expenditures and prescription volumes. Between 2008 and 2021, prescription volumes have been increasing at a rate of 1% to 4% per year, with 2020 being an exception as the volume decreased slightly from the year prior due to COVID-19 (−3%). Similarly, total Medicare and Medicaid expenditures have been growing at a rate of almost 5% per year.¹⁸ Based on our study results, it appears the total value of payments made between 2017 and 2021 increased at a rate that outpaced prescription volume and expenditures; however, it is difficult to draw conclusions about the relationship between payments made to dermatologists and spending without examining prescriptions specific to dermatologists in the OPD dataset. This relationship could be further explored in future studies.

COVID-19 Restrictions Impacted Payments in 2021—We hypothesize that COVID-19–related restrictions on traveling and in-person meetings led to a decrease in the number of payments, total payment amount, and mean total value of payments received per dermatologist. Notably, compensation for services other than consulting, including speaking fees, had the most precipitous decrease in total payment amount. On the other hand, honoraria and consulting fees were least impacted, as many dermatologists were still able to maintain relationships with industry on an advisory basis without traveling. From 2020 to 2021, the number of total payments and dollar amounts increased with easing of COVID-19 restrictions; however, they had not yet rebounded to 2019 levels during the study period. It will be interesting to continue monitoring these trends once data from future years become available.

Top-Compensated Dermatologists—Our study results also show that for all years from 2017 through 2021, the majority of industry payments were made to a small concentrated percentage of top-compensated dermatologists, which may reflect larger and more frequent payments to those identified by pharmaceutical companies as thought leaders and key opinion leaders in the field or those who are more willing to establish extensive ties with industry. Similarly skewed distributions in payments have been shown in other medical subspecialties including neurosurgery, plastic surgery, otolaryngology, and orthopedics.^4,6,19,20 It also is apparent that the majority of compensated dermatologists in the OPD maintain relatively small ties with industry. For every year from 2017 to 2021, more than half of compensated dermatologists received total payments of less than $500 per year, most of which stemmed from the food and beverage category. Interestingly, a prior study showed that patient perceptions of industry-physician ties may be more strongly impacted by the payment category than the amount.²¹ For example, respondents viewed payments for meals and lodging more negatively, as they were seen more as personal gifts without direct benefit to patients. Conversely, respondents held more positive views of physicians who received free drug samples, which were perceived as benefiting patients, as well as those receiving consulting fees, which were perceived as a signal of physician expertise. Notably, in the same study, physicians who received no payments from industry were seen as honest but also were viewed by some respondents as being inexperienced or uninformed about new treatments.²¹

The contribution and public perception of dermatologists who conduct investigator-initiated research utilizing other types of funding (eg, government grants) also are important to consider but were not directly assessed within the scope of the current study.

Sex Disparities in Compensation—Multiple studies in the literature have demonstrated that sex inequities exist across medical specialties.^22,23 In dermatology, although women make up slightly more than 50% of board-certified dermatologists, they continue to be underrepresented compared with men in leadership positions, academic rank, research funding, and lectureships at national meetings.^24-27 In survey-based studies specifically examining gender-based physician compensation, male dermatologists were found to earn higher salaries than their female counterparts in both private practice and academic settings, even after adjusting for work hours, practice characteristics, and academic rank.^28,29

Our study contributes to the growing body of evidence suggesting that sex inequities also may exist with regard to financial payments from industry. Our results showed that, although the number of male and female dermatologists with industry relationships was similar each year, the number of payments made and total payment amount were both significantly (P<.001) higher for male dermatologists from 2017 through 2021. In 2021, the mean payment amount ($201.57 for male dermatologists; $117.73 for female dermatologists) and mean total amount of payments received ($6172.89 and $2957.79, respectively) also were significantly higher for male compared with female dermatologists (P<.001). The cause of this disparity likely is multifactorial and warrants additional studies in the future. One hypothesis in the existing literature is that male physicians may be more inclined to seek out relationships with industry; it also is possible that disparities in research funding, academic rank, and speaking opportunities at national conferences detailed previously may contribute to inequities in industry payments as companies seek out perceived leaders in the field.³⁰

Limitations and Future Directions—Several important limitations of our study warrant further consideration. As with any database study, the accuracy of the results presented and the conclusions drawn are highly dependent on the precision of the available data, which is reliant on transparent documentation by pharmaceutical companies and physicians. There are no independent methods of verifying the information reported. There have been reports in the literature questioning the utility of the OPD data and risk for misinterpretation.^16,31 Furthermore, the OPD only includes companies whose products are covered by government-sponsored programs, such as Medicare and Medicaid, and therefore does not encompass the totality of industry-dermatologist relationships. We also focused specifically on board-certified dermatologists and did not analyze the extent of industry relationships involving residents, nurses, physician assistants, and other critical members of health care teams that may impact patient care. Differences between academic and private practice payments also could not be examined using the OPD but could present an interesting area for future studies.

Despite these limitations, our study was extensive, using the publicly available OPD to analyze trends and disparities in financial relationships between dermatologists and industry partners from 2017 through 2021. Notably, these findings are not intended to provide judgment or seek to tease out financial relationships that are beneficial for patient care from those that are not; rather, they are intended only to lend additional transparency, provoke thought, and encourage future studies and discussion surrounding this important topic.

Conclusion

Financial relationships between dermatologists and industry are complex and are becoming more prevalent, as shown in our study. These relationships may be critical to facilitate novel patient-centered research and growth in the field of dermatology; however, they also have the potential to be seen as bias in patient care. Transparent reporting of these relationships is an important step in future research regarding the effects of different payment types and serves as the basis for further understanding industry-dermatologist relationships as well as any inequities that exist in the distribution of payments. We encourage all dermatologists to review their public profiles in the OPD. Physicians have the opportunity to review all payment data reported by companies and challenge the accuracy of the data if necessary.

Financial relationships between physicians and industry are prevalent and complex and may have implications for patient care. A 2007 study reported that 94% of 3167 physicians surveyed had established some form of paid relationship with companies in the pharmaceutical industry.¹ To facilitate increased transparency around these relationships, lawmakers passed the Physician Payments Sunshine Act in 2010, which requires pharmaceutical companies and device manufacturers to report all payments made to physicians.² Mandatory disclosures include meals, honoraria, travel expenses, grants, and ownership or investment interests greater than $10. The information is displayed publicly in the Open Payments database (OPD)(https://openpayments-data.cms.gov/), a platform run by the Centers for Medicare and Medicaid Services.

The OPD allows for in-depth analyses of industry payments made to physicians. Many medical specialties—including orthopedics,^3-5 plastic surgery,^6,7 ophthalmology,⁸ and gastroenterology⁹—have published extensive literature characterizing the nature of these payments and disparities in the distribution of payments based on sex, geographic distribution, and other factors. After the first full year of OPD data collection for dermatology in 2014, Feng et al¹⁰ examined the number, amount, and nature of industry payments to dermatologists, as well as their geographic distribution for that year. As a follow-up to this initial research, Schlager et al¹¹ characterized payments made to dermatologists for the year 2016 and found an increase in the total payments, mean payments, and number of dermatologists receiving payments compared with the 2014 data.

Our study aimed to characterize the last 5 years of available OPD data—from January 1, 2017, to December 31, 2021—to further explore trends in industry payments made to dermatologists. In particular, we examined the effects of the COVID-19 pandemic on payments as well as sex disparities and the distribution of industry payments.

Methods

We performed a retrospective analysis of the OPD for the general payment datasets from January 1, 2017, to December 31, 2021. The results were filtered to include only payments made to dermatologists, excluding physicians from other specialties, physician assistants, and other types of practitioners. Data for each physician were grouped by National Provider Identifier (NPI) for providers included in the set, allowing for analysis at the individual level. Data on sex were extracted from the National Plan & Provider Enumeration System’s monthly data dissemination for NPIs for July 2023 (when the study was conducted) and were joined to the OPD data using the NPI number reported for each physician. All data were extracted, transformed, and analyzed using R software (version 4.2.1). Figures and visualizations were produced using Microsoft Excel 2016.

Results

In 2017, a total of 358,884 payments were made by industry to dermatologists, accounting for nearly $58.0 million. The mean total value of payments received per dermatologist was $5231.74, and the mean payment amount was $161.49. In 2018, the total number of payments increased year-over-year by 5.5% (378,509 payments), the total value of payments received increased by 7.5% (approximately $62.3 million), and the mean total value of payments received per dermatologist increased by 5.3% ($5508.98). In 2019, the total number of payments increased by 3.0% (389,670 total payments), the total value of payments recieved increased by 13.2% (approximately $70.5 million), and the mean total value of payments received per dermatologist increased by 11.3% ($6133.45). All of these values decreased in 2020, likely due to COVID-19–related restrictions on travel and meetings (total number of payments, 208,470 [−46.5%]; total value of payments received, approximately $37.5 million [−46.9%], mean total value of payments received per dermatologist, $3757.27 [−38.7%]), but the mean payment amount remained stable at $179.47. In 2021, the total number of payments (295,808 [+41.9%]), total value of payments received (approximately $50.3 million [+34.4%]), and mean total value of payments received per dermatologist ($4707.88 [+25.3%]) all rebounded, but not to pre-2020 levels (Table 1). When looking at the geographic distribution of payments, the top 5 states receiving the highest total value of payments during the study period included California ($41.51 million), New York ($32.26 million), Florida ($21.38 million), Texas ($19.93 million), and Pennsylvania ($11.69 million).

For each year from 2017 to 2021, more than 80% of payments made to dermatologists were less than $50. The majority (60.7%–75.8%) were in the $10 to $50 range. Between 4% and 5% of payments were more than $1000 for each year. Fewer than 10% of dermatologists received more than $5000 in total payments per year. Most dermatologists (33.3%–36.9%) received $100 to $500 per year. The distribution of payments stratified by number of payments made by amount and payment amount per dermatologist is further delineated in Table 2.

Comment

Benefits of Physician Relationships With Industry—The Physician Payments Sunshine Act increased transparency of industry payments to physicians by creating the OPD through which these relationships can be reported.¹² The effects of these relationships on treatment practices have been the subject of many studies in recent years. Some have suggested that industry ties may impact prescription patterns of endorsed medications.¹³ It also has been reported that the chance of a research study identifying a positive outcome for a particular treatment is higher when the study is funded by a pharmaceutical company compared to other sponsors.¹⁴ On the other hand, some researchers have argued that, when established and maintained in an ethical manner, industry-physician relationships may help practitioners stay updated on the newest treatment paradigms and benefit patient care.¹⁵ Industry relationships may help drive innovation of new products with direct input from frontline physicians who take care of the patients these products aim to help.

Limitations of the OPD—Critics of the OPD have argued that the reported data lack sufficient context and are not easily interpretable by most patients.¹⁶ In addition, many patients might not know about the existence of the database. Indeed, one national survey-based study showed that only 12% of 3542 respondents knew that this information was publicly available, and only 5% knew whether their own physician had received industry payments.¹⁷

Increased Payments From Industry—Our analysis builds on previously reported data in dermatology from 2014 to 2016.^10,11 We found that the trends of increasing numbers and dollar amounts of payments made by industry to dermatologists continued from 2017 to 2019, which may reflect the intended effects of the Physician Payments Sunshine Act, as more payments are being reported in a transparent manner. It also shows that relationships between industry and dermatologists have become more commonplace over time.

It is important to consider these trends in the context of overall Medicare expenditures and prescription volumes. Between 2008 and 2021, prescription volumes have been increasing at a rate of 1% to 4% per year, with 2020 being an exception as the volume decreased slightly from the year prior due to COVID-19 (−3%). Similarly, total Medicare and Medicaid expenditures have been growing at a rate of almost 5% per year.¹⁸ Based on our study results, it appears the total value of payments made between 2017 and 2021 increased at a rate that outpaced prescription volume and expenditures; however, it is difficult to draw conclusions about the relationship between payments made to dermatologists and spending without examining prescriptions specific to dermatologists in the OPD dataset. This relationship could be further explored in future studies.

COVID-19 Restrictions Impacted Payments in 2021—We hypothesize that COVID-19–related restrictions on traveling and in-person meetings led to a decrease in the number of payments, total payment amount, and mean total value of payments received per dermatologist. Notably, compensation for services other than consulting, including speaking fees, had the most precipitous decrease in total payment amount. On the other hand, honoraria and consulting fees were least impacted, as many dermatologists were still able to maintain relationships with industry on an advisory basis without traveling. From 2020 to 2021, the number of total payments and dollar amounts increased with easing of COVID-19 restrictions; however, they had not yet rebounded to 2019 levels during the study period. It will be interesting to continue monitoring these trends once data from future years become available.

Top-Compensated Dermatologists—Our study results also show that for all years from 2017 through 2021, the majority of industry payments were made to a small concentrated percentage of top-compensated dermatologists, which may reflect larger and more frequent payments to those identified by pharmaceutical companies as thought leaders and key opinion leaders in the field or those who are more willing to establish extensive ties with industry. Similarly skewed distributions in payments have been shown in other medical subspecialties including neurosurgery, plastic surgery, otolaryngology, and orthopedics.^4,6,19,20 It also is apparent that the majority of compensated dermatologists in the OPD maintain relatively small ties with industry. For every year from 2017 to 2021, more than half of compensated dermatologists received total payments of less than $500 per year, most of which stemmed from the food and beverage category. Interestingly, a prior study showed that patient perceptions of industry-physician ties may be more strongly impacted by the payment category than the amount.²¹ For example, respondents viewed payments for meals and lodging more negatively, as they were seen more as personal gifts without direct benefit to patients. Conversely, respondents held more positive views of physicians who received free drug samples, which were perceived as benefiting patients, as well as those receiving consulting fees, which were perceived as a signal of physician expertise. Notably, in the same study, physicians who received no payments from industry were seen as honest but also were viewed by some respondents as being inexperienced or uninformed about new treatments.²¹

The contribution and public perception of dermatologists who conduct investigator-initiated research utilizing other types of funding (eg, government grants) also are important to consider but were not directly assessed within the scope of the current study.

Sex Disparities in Compensation—Multiple studies in the literature have demonstrated that sex inequities exist across medical specialties.^22,23 In dermatology, although women make up slightly more than 50% of board-certified dermatologists, they continue to be underrepresented compared with men in leadership positions, academic rank, research funding, and lectureships at national meetings.^24-27 In survey-based studies specifically examining gender-based physician compensation, male dermatologists were found to earn higher salaries than their female counterparts in both private practice and academic settings, even after adjusting for work hours, practice characteristics, and academic rank.^28,29

Our study contributes to the growing body of evidence suggesting that sex inequities also may exist with regard to financial payments from industry. Our results showed that, although the number of male and female dermatologists with industry relationships was similar each year, the number of payments made and total payment amount were both significantly (P<.001) higher for male dermatologists from 2017 through 2021. In 2021, the mean payment amount ($201.57 for male dermatologists; $117.73 for female dermatologists) and mean total amount of payments received ($6172.89 and $2957.79, respectively) also were significantly higher for male compared with female dermatologists (P<.001). The cause of this disparity likely is multifactorial and warrants additional studies in the future. One hypothesis in the existing literature is that male physicians may be more inclined to seek out relationships with industry; it also is possible that disparities in research funding, academic rank, and speaking opportunities at national conferences detailed previously may contribute to inequities in industry payments as companies seek out perceived leaders in the field.³⁰

Limitations and Future Directions—Several important limitations of our study warrant further consideration. As with any database study, the accuracy of the results presented and the conclusions drawn are highly dependent on the precision of the available data, which is reliant on transparent documentation by pharmaceutical companies and physicians. There are no independent methods of verifying the information reported. There have been reports in the literature questioning the utility of the OPD data and risk for misinterpretation.^16,31 Furthermore, the OPD only includes companies whose products are covered by government-sponsored programs, such as Medicare and Medicaid, and therefore does not encompass the totality of industry-dermatologist relationships. We also focused specifically on board-certified dermatologists and did not analyze the extent of industry relationships involving residents, nurses, physician assistants, and other critical members of health care teams that may impact patient care. Differences between academic and private practice payments also could not be examined using the OPD but could present an interesting area for future studies.

Despite these limitations, our study was extensive, using the publicly available OPD to analyze trends and disparities in financial relationships between dermatologists and industry partners from 2017 through 2021. Notably, these findings are not intended to provide judgment or seek to tease out financial relationships that are beneficial for patient care from those that are not; rather, they are intended only to lend additional transparency, provoke thought, and encourage future studies and discussion surrounding this important topic.

Conclusion

Financial relationships between dermatologists and industry are complex and are becoming more prevalent, as shown in our study. These relationships may be critical to facilitate novel patient-centered research and growth in the field of dermatology; however, they also have the potential to be seen as bias in patient care. Transparent reporting of these relationships is an important step in future research regarding the effects of different payment types and serves as the basis for further understanding industry-dermatologist relationships as well as any inequities that exist in the distribution of payments. We encourage all dermatologists to review their public profiles in the OPD. Physicians have the opportunity to review all payment data reported by companies and challenge the accuracy of the data if necessary.

Financial relationships between physicians and industry are prevalent and complex and may have implications for patient care. A 2007 study reported that 94% of 3167 physicians surveyed had established some form of paid relationship with companies in the pharmaceutical industry.¹ To facilitate increased transparency around these relationships, lawmakers passed the Physician Payments Sunshine Act in 2010, which requires pharmaceutical companies and device manufacturers to report all payments made to physicians.² Mandatory disclosures include meals, honoraria, travel expenses, grants, and ownership or investment interests greater than $10. The information is displayed publicly in the Open Payments database (OPD)(https://openpayments-data.cms.gov/), a platform run by the Centers for Medicare and Medicaid Services.

The OPD allows for in-depth analyses of industry payments made to physicians. Many medical specialties—including orthopedics,^3-5 plastic surgery,^6,7 ophthalmology,⁸ and gastroenterology⁹—have published extensive literature characterizing the nature of these payments and disparities in the distribution of payments based on sex, geographic distribution, and other factors. After the first full year of OPD data collection for dermatology in 2014, Feng et al¹⁰ examined the number, amount, and nature of industry payments to dermatologists, as well as their geographic distribution for that year. As a follow-up to this initial research, Schlager et al¹¹ characterized payments made to dermatologists for the year 2016 and found an increase in the total payments, mean payments, and number of dermatologists receiving payments compared with the 2014 data.

Our study aimed to characterize the last 5 years of available OPD data—from January 1, 2017, to December 31, 2021—to further explore trends in industry payments made to dermatologists. In particular, we examined the effects of the COVID-19 pandemic on payments as well as sex disparities and the distribution of industry payments.

Methods

We performed a retrospective analysis of the OPD for the general payment datasets from January 1, 2017, to December 31, 2021. The results were filtered to include only payments made to dermatologists, excluding physicians from other specialties, physician assistants, and other types of practitioners. Data for each physician were grouped by National Provider Identifier (NPI) for providers included in the set, allowing for analysis at the individual level. Data on sex were extracted from the National Plan & Provider Enumeration System’s monthly data dissemination for NPIs for July 2023 (when the study was conducted) and were joined to the OPD data using the NPI number reported for each physician. All data were extracted, transformed, and analyzed using R software (version 4.2.1). Figures and visualizations were produced using Microsoft Excel 2016.

Results

In 2017, a total of 358,884 payments were made by industry to dermatologists, accounting for nearly $58.0 million. The mean total value of payments received per dermatologist was $5231.74, and the mean payment amount was $161.49. In 2018, the total number of payments increased year-over-year by 5.5% (378,509 payments), the total value of payments received increased by 7.5% (approximately $62.3 million), and the mean total value of payments received per dermatologist increased by 5.3% ($5508.98). In 2019, the total number of payments increased by 3.0% (389,670 total payments), the total value of payments recieved increased by 13.2% (approximately $70.5 million), and the mean total value of payments received per dermatologist increased by 11.3% ($6133.45). All of these values decreased in 2020, likely due to COVID-19–related restrictions on travel and meetings (total number of payments, 208,470 [−46.5%]; total value of payments received, approximately $37.5 million [−46.9%], mean total value of payments received per dermatologist, $3757.27 [−38.7%]), but the mean payment amount remained stable at $179.47. In 2021, the total number of payments (295,808 [+41.9%]), total value of payments received (approximately $50.3 million [+34.4%]), and mean total value of payments received per dermatologist ($4707.88 [+25.3%]) all rebounded, but not to pre-2020 levels (Table 1). When looking at the geographic distribution of payments, the top 5 states receiving the highest total value of payments during the study period included California ($41.51 million), New York ($32.26 million), Florida ($21.38 million), Texas ($19.93 million), and Pennsylvania ($11.69 million).

For each year from 2017 to 2021, more than 80% of payments made to dermatologists were less than $50. The majority (60.7%–75.8%) were in the $10 to $50 range. Between 4% and 5% of payments were more than $1000 for each year. Fewer than 10% of dermatologists received more than $5000 in total payments per year. Most dermatologists (33.3%–36.9%) received $100 to $500 per year. The distribution of payments stratified by number of payments made by amount and payment amount per dermatologist is further delineated in Table 2.

Comment

Benefits of Physician Relationships With Industry—The Physician Payments Sunshine Act increased transparency of industry payments to physicians by creating the OPD through which these relationships can be reported.¹² The effects of these relationships on treatment practices have been the subject of many studies in recent years. Some have suggested that industry ties may impact prescription patterns of endorsed medications.¹³ It also has been reported that the chance of a research study identifying a positive outcome for a particular treatment is higher when the study is funded by a pharmaceutical company compared to other sponsors.¹⁴ On the other hand, some researchers have argued that, when established and maintained in an ethical manner, industry-physician relationships may help practitioners stay updated on the newest treatment paradigms and benefit patient care.¹⁵ Industry relationships may help drive innovation of new products with direct input from frontline physicians who take care of the patients these products aim to help.

Limitations of the OPD—Critics of the OPD have argued that the reported data lack sufficient context and are not easily interpretable by most patients.¹⁶ In addition, many patients might not know about the existence of the database. Indeed, one national survey-based study showed that only 12% of 3542 respondents knew that this information was publicly available, and only 5% knew whether their own physician had received industry payments.¹⁷

Increased Payments From Industry—Our analysis builds on previously reported data in dermatology from 2014 to 2016.^10,11 We found that the trends of increasing numbers and dollar amounts of payments made by industry to dermatologists continued from 2017 to 2019, which may reflect the intended effects of the Physician Payments Sunshine Act, as more payments are being reported in a transparent manner. It also shows that relationships between industry and dermatologists have become more commonplace over time.

It is important to consider these trends in the context of overall Medicare expenditures and prescription volumes. Between 2008 and 2021, prescription volumes have been increasing at a rate of 1% to 4% per year, with 2020 being an exception as the volume decreased slightly from the year prior due to COVID-19 (−3%). Similarly, total Medicare and Medicaid expenditures have been growing at a rate of almost 5% per year.¹⁸ Based on our study results, it appears the total value of payments made between 2017 and 2021 increased at a rate that outpaced prescription volume and expenditures; however, it is difficult to draw conclusions about the relationship between payments made to dermatologists and spending without examining prescriptions specific to dermatologists in the OPD dataset. This relationship could be further explored in future studies.

COVID-19 Restrictions Impacted Payments in 2021—We hypothesize that COVID-19–related restrictions on traveling and in-person meetings led to a decrease in the number of payments, total payment amount, and mean total value of payments received per dermatologist. Notably, compensation for services other than consulting, including speaking fees, had the most precipitous decrease in total payment amount. On the other hand, honoraria and consulting fees were least impacted, as many dermatologists were still able to maintain relationships with industry on an advisory basis without traveling. From 2020 to 2021, the number of total payments and dollar amounts increased with easing of COVID-19 restrictions; however, they had not yet rebounded to 2019 levels during the study period. It will be interesting to continue monitoring these trends once data from future years become available.

Top-Compensated Dermatologists—Our study results also show that for all years from 2017 through 2021, the majority of industry payments were made to a small concentrated percentage of top-compensated dermatologists, which may reflect larger and more frequent payments to those identified by pharmaceutical companies as thought leaders and key opinion leaders in the field or those who are more willing to establish extensive ties with industry. Similarly skewed distributions in payments have been shown in other medical subspecialties including neurosurgery, plastic surgery, otolaryngology, and orthopedics.^4,6,19,20 It also is apparent that the majority of compensated dermatologists in the OPD maintain relatively small ties with industry. For every year from 2017 to 2021, more than half of compensated dermatologists received total payments of less than $500 per year, most of which stemmed from the food and beverage category. Interestingly, a prior study showed that patient perceptions of industry-physician ties may be more strongly impacted by the payment category than the amount.²¹ For example, respondents viewed payments for meals and lodging more negatively, as they were seen more as personal gifts without direct benefit to patients. Conversely, respondents held more positive views of physicians who received free drug samples, which were perceived as benefiting patients, as well as those receiving consulting fees, which were perceived as a signal of physician expertise. Notably, in the same study, physicians who received no payments from industry were seen as honest but also were viewed by some respondents as being inexperienced or uninformed about new treatments.²¹

The contribution and public perception of dermatologists who conduct investigator-initiated research utilizing other types of funding (eg, government grants) also are important to consider but were not directly assessed within the scope of the current study.

Sex Disparities in Compensation—Multiple studies in the literature have demonstrated that sex inequities exist across medical specialties.^22,23 In dermatology, although women make up slightly more than 50% of board-certified dermatologists, they continue to be underrepresented compared with men in leadership positions, academic rank, research funding, and lectureships at national meetings.^24-27 In survey-based studies specifically examining gender-based physician compensation, male dermatologists were found to earn higher salaries than their female counterparts in both private practice and academic settings, even after adjusting for work hours, practice characteristics, and academic rank.^28,29

Our study contributes to the growing body of evidence suggesting that sex inequities also may exist with regard to financial payments from industry. Our results showed that, although the number of male and female dermatologists with industry relationships was similar each year, the number of payments made and total payment amount were both significantly (P<.001) higher for male dermatologists from 2017 through 2021. In 2021, the mean payment amount ($201.57 for male dermatologists; $117.73 for female dermatologists) and mean total amount of payments received ($6172.89 and $2957.79, respectively) also were significantly higher for male compared with female dermatologists (P<.001). The cause of this disparity likely is multifactorial and warrants additional studies in the future. One hypothesis in the existing literature is that male physicians may be more inclined to seek out relationships with industry; it also is possible that disparities in research funding, academic rank, and speaking opportunities at national conferences detailed previously may contribute to inequities in industry payments as companies seek out perceived leaders in the field.³⁰

Limitations and Future Directions—Several important limitations of our study warrant further consideration. As with any database study, the accuracy of the results presented and the conclusions drawn are highly dependent on the precision of the available data, which is reliant on transparent documentation by pharmaceutical companies and physicians. There are no independent methods of verifying the information reported. There have been reports in the literature questioning the utility of the OPD data and risk for misinterpretation.^16,31 Furthermore, the OPD only includes companies whose products are covered by government-sponsored programs, such as Medicare and Medicaid, and therefore does not encompass the totality of industry-dermatologist relationships. We also focused specifically on board-certified dermatologists and did not analyze the extent of industry relationships involving residents, nurses, physician assistants, and other critical members of health care teams that may impact patient care. Differences between academic and private practice payments also could not be examined using the OPD but could present an interesting area for future studies.

Despite these limitations, our study was extensive, using the publicly available OPD to analyze trends and disparities in financial relationships between dermatologists and industry partners from 2017 through 2021. Notably, these findings are not intended to provide judgment or seek to tease out financial relationships that are beneficial for patient care from those that are not; rather, they are intended only to lend additional transparency, provoke thought, and encourage future studies and discussion surrounding this important topic.

Conclusion

Financial relationships between dermatologists and industry are complex and are becoming more prevalent, as shown in our study. These relationships may be critical to facilitate novel patient-centered research and growth in the field of dermatology; however, they also have the potential to be seen as bias in patient care. Transparent reporting of these relationships is an important step in future research regarding the effects of different payment types and serves as the basis for further understanding industry-dermatologist relationships as well as any inequities that exist in the distribution of payments. We encourage all dermatologists to review their public profiles in the OPD. Physicians have the opportunity to review all payment data reported by companies and challenge the accuracy of the data if necessary.

TOPLINE:

Researchers identified thousands of census tracts as priority zones where improving the screening of colorectal cancer (CRC) may benefit Hispanic or Latino communities.

METHODOLOGY:

• Hispanic or Latino individuals have the lowest rate of CRC screening among the six broader census-designated racial or ethnic groups in the United States, while they face a high proportion of cancer deaths due to CRC.
• Researchers performed a cross-sectional ecologic study using 2021 Centers for Disease Control and Prevention PLACES and 2019 American Community Survey data to identify priority zones for CRC screening where intervention programs may be targeted.
• They analyzed a total of 72,136 US census tracts, representing 98.7% of all US census tracts.
• Nine race and ethnic groups were selected on the basis of the population size and categorizations used in prior research on health or cancer disparity: non-Hispanic Black, non-Hispanic White, Asian, Mexican, Puerto Rican, Cuban, Dominican, Central or South American, and “other race.”
• Geographically weighted regression and Getis-Ord Gi* hot spot procedures were used to identify the screening priority zones for all Hispanic or Latino groups.

TAKEAWAY:

• The analysis identified 6519 hot spot tracts for Mexican, 3477 for Puerto Rican, 3522 for Central or South American, 1069 for Dominican, and 1424 for Cuban individuals. The average rates of screening for CRC were 57.2%, 59.9%, 59.3%, 58.9%, and 60.4%, respectively.
• The percentage of Cuban individuals showed a positive association with the CRC screening rate, while the percentage of Mexican, Puerto Rican, Dominican, and Central or South American Hispanic or Latino individuals and of the uninsured showed a negative association with the CRC screening rate.
• The priority zones for Mexican communities were primarily located in Texas and southwestern United States, while those for Puerto Rican, Central or South American, and other populations were located in southern Florida and the metro areas of New York City and Texas.

IN PRACTICE:

“Our findings and interactive web map may serve as a translational tool for public health authorities, policymakers, clinicians, and other stakeholders to target investment and interventions to increase guideline-concordant CRC screening uptake benefiting specific H/L [Hispanic or Latino] communities in the United States,” the authors wrote. “These data can inform more precise neighborhood-level interventions to increase CRC screening considering unique characteristics important for these H/L [Hispanic or Latino] groups.”

SOURCE:

The study, led by R. Blake Buchalter, PhD, MPH, Center for Populations Health Research, Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, was published online in the American Journal of Public Health.

LIMITATIONS: 

The study’s cross-sectional design limited the ability to infer causality. The use of census tract-level data did not capture individual-level screening behaviors. The study did not account for nativity status or years of migration owing to the lack of data. The Centers for Disease Control and Prevention PLACES dataset may not represent the actual screening delivered as it is based on survey data. 

DISCLOSURES:

The National Cancer Institute partially supported this study. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Researchers identified thousands of census tracts as priority zones where improving the screening of colorectal cancer (CRC) may benefit Hispanic or Latino communities.

METHODOLOGY:

• Hispanic or Latino individuals have the lowest rate of CRC screening among the six broader census-designated racial or ethnic groups in the United States, while they face a high proportion of cancer deaths due to CRC.
• Researchers performed a cross-sectional ecologic study using 2021 Centers for Disease Control and Prevention PLACES and 2019 American Community Survey data to identify priority zones for CRC screening where intervention programs may be targeted.
• They analyzed a total of 72,136 US census tracts, representing 98.7% of all US census tracts.
• Nine race and ethnic groups were selected on the basis of the population size and categorizations used in prior research on health or cancer disparity: non-Hispanic Black, non-Hispanic White, Asian, Mexican, Puerto Rican, Cuban, Dominican, Central or South American, and “other race.”
• Geographically weighted regression and Getis-Ord Gi* hot spot procedures were used to identify the screening priority zones for all Hispanic or Latino groups.

TAKEAWAY:

• The analysis identified 6519 hot spot tracts for Mexican, 3477 for Puerto Rican, 3522 for Central or South American, 1069 for Dominican, and 1424 for Cuban individuals. The average rates of screening for CRC were 57.2%, 59.9%, 59.3%, 58.9%, and 60.4%, respectively.
• The percentage of Cuban individuals showed a positive association with the CRC screening rate, while the percentage of Mexican, Puerto Rican, Dominican, and Central or South American Hispanic or Latino individuals and of the uninsured showed a negative association with the CRC screening rate.
• The priority zones for Mexican communities were primarily located in Texas and southwestern United States, while those for Puerto Rican, Central or South American, and other populations were located in southern Florida and the metro areas of New York City and Texas.

IN PRACTICE:

“Our findings and interactive web map may serve as a translational tool for public health authorities, policymakers, clinicians, and other stakeholders to target investment and interventions to increase guideline-concordant CRC screening uptake benefiting specific H/L [Hispanic or Latino] communities in the United States,” the authors wrote. “These data can inform more precise neighborhood-level interventions to increase CRC screening considering unique characteristics important for these H/L [Hispanic or Latino] groups.”

SOURCE:

The study, led by R. Blake Buchalter, PhD, MPH, Center for Populations Health Research, Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, was published online in the American Journal of Public Health.

LIMITATIONS: 

The study’s cross-sectional design limited the ability to infer causality. The use of census tract-level data did not capture individual-level screening behaviors. The study did not account for nativity status or years of migration owing to the lack of data. The Centers for Disease Control and Prevention PLACES dataset may not represent the actual screening delivered as it is based on survey data. 

DISCLOSURES:

The National Cancer Institute partially supported this study. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Researchers identified thousands of census tracts as priority zones where improving the screening of colorectal cancer (CRC) may benefit Hispanic or Latino communities.

METHODOLOGY:

• Hispanic or Latino individuals have the lowest rate of CRC screening among the six broader census-designated racial or ethnic groups in the United States, while they face a high proportion of cancer deaths due to CRC.
• Researchers performed a cross-sectional ecologic study using 2021 Centers for Disease Control and Prevention PLACES and 2019 American Community Survey data to identify priority zones for CRC screening where intervention programs may be targeted.
• They analyzed a total of 72,136 US census tracts, representing 98.7% of all US census tracts.
• Nine race and ethnic groups were selected on the basis of the population size and categorizations used in prior research on health or cancer disparity: non-Hispanic Black, non-Hispanic White, Asian, Mexican, Puerto Rican, Cuban, Dominican, Central or South American, and “other race.”
• Geographically weighted regression and Getis-Ord Gi* hot spot procedures were used to identify the screening priority zones for all Hispanic or Latino groups.

TAKEAWAY:

• The analysis identified 6519 hot spot tracts for Mexican, 3477 for Puerto Rican, 3522 for Central or South American, 1069 for Dominican, and 1424 for Cuban individuals. The average rates of screening for CRC were 57.2%, 59.9%, 59.3%, 58.9%, and 60.4%, respectively.
• The percentage of Cuban individuals showed a positive association with the CRC screening rate, while the percentage of Mexican, Puerto Rican, Dominican, and Central or South American Hispanic or Latino individuals and of the uninsured showed a negative association with the CRC screening rate.
• The priority zones for Mexican communities were primarily located in Texas and southwestern United States, while those for Puerto Rican, Central or South American, and other populations were located in southern Florida and the metro areas of New York City and Texas.

IN PRACTICE:

“Our findings and interactive web map may serve as a translational tool for public health authorities, policymakers, clinicians, and other stakeholders to target investment and interventions to increase guideline-concordant CRC screening uptake benefiting specific H/L [Hispanic or Latino] communities in the United States,” the authors wrote. “These data can inform more precise neighborhood-level interventions to increase CRC screening considering unique characteristics important for these H/L [Hispanic or Latino] groups.”

SOURCE:

The study, led by R. Blake Buchalter, PhD, MPH, Center for Populations Health Research, Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, was published online in the American Journal of Public Health.

LIMITATIONS: 

The study’s cross-sectional design limited the ability to infer causality. The use of census tract-level data did not capture individual-level screening behaviors. The study did not account for nativity status or years of migration owing to the lack of data. The Centers for Disease Control and Prevention PLACES dataset may not represent the actual screening delivered as it is based on survey data. 

DISCLOSURES:

The National Cancer Institute partially supported this study. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.

This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.

Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.

Sexual dysfunction is a common and significant late effect among CCS. The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
 

Characteristics and Mechanisms

Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.

As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.

Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.

Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects. 
 

Sexual Function in CCS

A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.

The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.

Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.

In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.

The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
 

Factors Influencing Sexual Function

The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.

Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.

Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.

Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.

The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.

Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.

Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.

Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
 

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.

This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.

Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.

Sexual dysfunction is a common and significant late effect among CCS. The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
 

Characteristics and Mechanisms

Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.

As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.

Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.

Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects. 
 

Sexual Function in CCS

A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.

The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.

Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.

In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.

The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
 

Factors Influencing Sexual Function

The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.

Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.

Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.

Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.

The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.

Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.

Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.

Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
 

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.

This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.

Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.

Sexual dysfunction is a common and significant late effect among CCS. The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
 

Characteristics and Mechanisms

Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.

As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.

Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.

Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects. 
 

Sexual Function in CCS

A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.

The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.

Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.

In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.

The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
 

Factors Influencing Sexual Function

The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.

Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.

Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.

Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.

The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.

Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.

Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.

Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
 

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Melasma (also known as chloasma faciei) is a common chronic skin disorder that results in well-demarcated, hyperpigmented, tan to dark patches that mostly appear in sun-exposed areas such as the face and neck and sometimes the arms. The exact prevalence or incidence is not known but is estimated to be 1% to 50% overall depending on the ethnic population and geographic location.^1,2 Melasma predominantly affects women, but research has shown that approximately 10% to 20% of men are affected by this condition.^3,4 Although melasma can affect patients of all skin types, it primarily affects those with darker skin tones.⁵ The groups most often affected are women of Black, Hispanic, Middle Eastern, and Southeast Asian ethnicity. Although the pathogenesis is complex and not fully understood, multiple pathways and etiologies have been theorized to cause melasma. Potential causes include exposure to UV radiation, oral contraceptives, hormonal changes, medications, thyroid dysfunction, genetics, and pregnancy.^6,7 Cytokines and growth factors, including adipokine and angiopoietin, synthesized by sebaceous glands play a role in the pathogenic mechanism of melasma. Cytokines and growth factors are hypothesized to modulate the function of melanocytes.⁸ Both melanocytes and sebocytes are controlled by α–melanocyte-stimulating hormone. Therefore, overexpression of α–melanocyte-stimulating hormone will result in overproduction of these 2 cell types, resulting in melasma. Melasma can be classified into 4 subtypes using Wood lamp examination: epidermal, dermal, mixed, or indeterminate.³ Furthermore, melasma is divided into subgroups based on the location: malar region, mandibular region, and centrofacial patch pattern.^9,10 The involvement of sebaceous glands in the pathogenesis of melasma may explain the predilection for the centrofacial region, which is the most common pattern.

The severity of melasma can be assessed using the melasma area and severity index (MASI), which is calculated by subjective assessment of 3 main factors: (1) facial area of involvement; (2) darkness of affected region; and (3) homogeneity, with the extent of melasma indicated by a score ranging from 0 to 48.¹¹ The modified MASI (mMASI) subsequently was introduced to assist with assessing the severity of melasma and creating distinct ranges for mild, moderate, and severe cases, ranging from 0 (mild) to 24 (severe).¹² Both indices are used in research to assess the improvement of melasma with treatment.

Patients with melasma report a decrease in quality of life, increased emotional stress, and lower self-esteem due to cosmesis.¹³ Treatment of melasma can be highly challenging and often is complicated by relapsing. Historically, the treatment of melasma has included the use of chemical lightening agents. Additional treatment options include the use of lasers and complex chemical peels,^9,10 but these interventions may result in adverse outcomes for individuals with darker skin tones. The current gold-standard treatment is topical hydroquinone and broad-spectrum sunscreen. Although hydroquinone is effective in the treatment of melasma, relapse is common. The goal of melasma management is not only to treat acute hyperpigmentation but also to prevent relapse. Other therapies that currently are being explored for the clinically sustained treatment of melasma include tranexamic acid (TXA)(trans-4-[aminomethyl]cyclohexanecarboxylic acid),^9,10 an antifibrinolytic agent routinely used to prevent blood loss during surgery and in the management of menorrhagia. It is a synthetic derivative of lysine and serves as a potent plasmin inhibitor by blocking the lysine-binding sites of plasminogen molecules, thus preventing the conversion of plasminogen to plasmin. It also prevents fibrinolysis and blood loss.

In addition to its hemostatic properties, TXA has been found to have hypopigmentation properties.^14,15 Plasminogen also can be found in human epidermal basal cells and human keratinocytes, and it is postulated that TXA’s interaction with these cells explains its hypopigmentation properties. Both UV radiation and hormones activate plasminogen into plasmin, resulting in the activation of tyrosinase and melanogenesis.^14,15 Tranexamic acid is postulated to inhibit the keratinocyte-plasminogen pathway, thus leading to the inhibition of UV-induced and hormone-induced pigmentation. Also, TXA serves as a competitive inhibitor for tyrosinase due to its structural similarity to tyrosine.¹⁵ The combination of these 2 mechanisms contributes to the skin-lightening effects of TXA, making it a potential treatment for melasma.

Furthermore, the use of microneedling is being explored as a treatment option for melasma. Microneedling creates microscopic punctures in the skin using tiny needles, resulting in a wound-healing response and skin resurfacing. The microneedling technique is utilized to create small holes in the skin, with needle depths that can be adjusted from 0.5 to 3.5 mm to target different layers of the dermis and allow for discreet application of TXA.¹⁶ We sought to look at the current literature on the use and effectiveness of microneedling in combination with TXA to treat melasma and prevent relapse.

Methods

A systematic review was performed of PubMed articles indexed for MEDLINE and Embase in November 2021 to compile available articles that studied TXA and microneedling as a treatment for melasma. The PubMed search terms were (melasma) AND (microneedling* OR ‘tranexamic acid’ OR TXA or TA). The Embase search terms were (cholasma OR melasma) AND (tranexamic acid OR TXA) AND (microneedling)(Figure). The search was then limited to ”randomized controlled trial” and ”clinical trial” in English-language journals. Duplicates were excluded. After thorough evaluation, articles that discussed the use of TXA in combination with treatment options other than microneedling also were excluded.

Results

The literature search yielded a total of 12 articles that assessed the effectiveness of TXA and microneedling for the treatment of melasma (Table).^17-28 Several articles concluded that TXA was equally effective at reducing melasma lesions when compared with the standard treatment of hydroquinone. Some of the reviewed articles also demonstrated the effectiveness of microneedling in improving melasma lesions as a stand-alone treatment. These studies highlighted the enhanced efficacy of the combined treatment of TXA and microneedling compared with their individual uses.^17-28

Comment

Melasma is a common chronic hyperpigmentation disorder, making its treatment clinically challenging. Many patients experience symptom relapses, and limited effective treatment options make achieving complete clearance difficult, underscoring the need for improved therapeutic approaches. Recently, researchers have explored alternative treatments to address the challenges of melasma management. Tranexamic acid is an antifibrinolytic used to prevent blood loss and has emerged as a potential treatment for melasma. Similarly, microneedling—a technique in which multiple punctures are made in the skin to activate and stimulate wound healing and skin rejuvenation—shows promise for melasma.

Oral TXA for Melasma—Oral TXA has been shown to reduce melasma lesions. Del Rosario et al¹⁷ recruited 44 women (39 of whom completed the study) with moderate to severe melasma and randomized them into 2 groups: oral TXA and placebo. This study demonstrated a 49% reduction in the mMASI score in all participants taking oral TXA (250 mg twice daily [BID]) compared with an 18% reduction in the control group (placebo capsule BID) after 3 months of treatment. In patients with moderate and severe melasma, 45% and 51% mMASI score reductions were reported in the treatment group, respectively, vs 16% and 19% score reductions in placebo group, respectively. These researchers concluded that oral TXA may be effective at treating moderate to severe melasma. Although patients with severe melasma had a better response to treatment, their improvement was not sustained compared with patients with moderate melasma after a 3-month posttreatment follow-up.¹⁷

Microneedling Plus TXA for Melasma—Microneedling alone has been shown to be effective for melasma. El Attar et al¹⁸ conducted a split-face study of microneedling (1.5-mm depth) plus topical TXA (0.5 mL)(right side of the face[treatment arm]) compared with microneedling (1.5-mm depth) plus topical vitamin C (0.5 mL)(left side of the face [control group]) in 20 women with melasma. The sessions were repeated every 2 weeks for a total of 6 sessions. Although researchers found no statistically significant differences between the 2 treatment sides, microneedling plus TXA showed a slight advantage over microneedling plus vitamin C in dermoscopic examination. Both sides showed improvement in pigmented lesions, but vitamin C–treated lesions did not show an improvement in vascularity vs TXA.¹⁸

Saleh et al¹⁹ further showed that combination treatment with microneedling and TXA may improve clinical outcomes better than microneedling alone. Their study demonstrated a reduction in MASI score that was significantly higher in the combination treatment group compared with the microneedling alone group (P=.001). There was a significant reduction in melanoma antigen recognized by T cells 1 (MART-1)–positive cells in the combination treatment group compared with the microneedling alone group (P=.001). Lastly, combined therapy improved melasma patches better than microneedling alone.¹⁹

Xu et al²⁰ conducted a split-face study (N=28) exploring the effectiveness of transdermal application of topical TXA using a microarray pen with microneedles (vibration at 3000×/min) plus topical TXA on one side of the face, while the other side received only topical TXA as a control. After 12 weeks of treatment, combination therapy with microneedling and TXA decreased brown spot scores, lowered melanin index (MI) values, improved blinded physician assessment, and improved patient satisfaction vs TXA therapy alone.²⁰

Kaur et al²¹ conducted a split-face, randomized, controlled trial of microneedling (1-mm depth) with TXA solution 10% vs microneedling (1-mm depth) with distilled water alone for 8 weeks (N=40). They graded participant responses to treatment using reductions in mMASI scores¹² at every 2 weeks of follow-up (no response, minimal or poor response=0%–25%; partial or fair response=26%–50%; good response=51%–75%; and excellent response=>75%). They reported an overall reduction in mMASI scores for both the treatment side and the control side in all participants, showing a 65.92% improvement in mean mMASI scores on the treatment side vs 20.75% improvement on the control side at week 8. Both sides showed statistically significant reductions in mean mMASI scores (P<.05). Clinically, 40% (16/40) of participants showed an excellent response to combined treatment compared with 0% (0/40) to microneedling alone. Overall, patient satisfaction was similar across both groups. This study demonstrated that microneedling alone improves melasma, but a combination of microneedling plus TXA showed a better clinical reduction in melasma. However, the researchers did not follow up with participants posttreatment, so it remains unclear if the improved clinical outcomes were sustained long-term.²¹

Ebrahim et al²² reported that the combination of 0.5 mL TXA (4 mg/mL) and microneedling (0.25- to 1-mm depth) was effective for melasma. Although there was improvement within microneedling and TXA, the study also showed that intradermal injection of TXA was significant in reducing mean mMASI scores and improving melasma (P<.001). The reduction in mMASI scores for the group receiving intradermal injections of TXA (left side; 74.8% reduction in mean mMASI score) vs the group receiving microneedling application of TXA (right side; 73.6% reduction in mean mMASI score) was not statistically significant. These findings suggest that the mode of TXA application may not be critical in determining clinical responses to TXA treatment. Although there was no reported statistically significant difference in clinical outcomes between the 2 treatments, patient satisfaction was higher on the microneedling side. Only 8 of 50 participants (16%) experienced recurrence 3 months posttreatment.²²

Saki et al²³ compared the efficacy of topical hydroquinone (2%) to intradermal TXA injections in treating melasma. They found intradermal TXA injections to be a clinically effective mode of treatment.²³

Sharma et al²⁴ explored the efficacy and safety of oral TXA by randomly assigning 100 Indian patients (20 of whom withdrew before study completion) with melasma into 2 groups: group A received TXA 250 mg twice daily, and group B received intradermal microinjections of TXA (4 mg/mL) every 4 weeks. The MASI scores were assessed at 4-week intervals for a total of 12 weeks. There was a decrease in MASI scores in both groups, and there was no statistically significant difference in mean percentage reduction in MASI scores between the 2 routes of drug administration, further suggesting the effectiveness of TXA independent of administration route. Two patients in group A relapsed at 24 weeks, and there were no relapses in group B, which may suggest a minimal superiority of TXA plus microneedling at providing more sustainable results compared with oral TXA alone. A notable limitation of this study was a high dropout rate as well as lack of long-term follow-up with participants, limiting the generalizability of the conclusions.²⁴

Cassiano et al²⁵ assigned 64 women with melasma to 1 of 3 treatment groups or a control group to compare the effectiveness of microneedling (M group: 1.5 mm; 2 sessions), oral TXA (T group: 250 mg/d twice daily for 60 days), and a combination of microneedling (2 sessions) and oral TXA (MT group: 250 mg/d twice daily for 60 days)with placebo for clinically reducing melasma lesions. The intervention period was 60 days followed by a 60-day maintenance phase for a total study period of 120 days. The researchers evaluated mMASI scores, quality of life, and difference in colorimetric luminosity. All treatment groups showed a reduction in mMASI scores at both 30 days and 60 days, indicating improved melasma severity. The MT and T groups had more significant improvement at 30 days compared with the control group (P<.03), suggesting that microneedling plus TXA and TXA alone promote faster improvement in melasma lesions. By 60 days, the M, T, and MT groups outperformed the control group, with no significant differences between the M, T, and MT groups. However, at the 120-day maintenance follow-up, the T group did not maintain its improvement compared with the control group. The M and MT groups showed no significance difference in effectiveness at 120 days, suggesting that microneedling may promote less frequent relapse and sustained remission compared to TXA alone.²⁵

Hydroquinone for Melasma—Additional studies on the use of TXA treatments show that TXA may be an equally effective alternative to the standard use of hydroquinone treatment. Shamsi Meymandi et al²⁶ did not find a statistically significant difference in treatment with TXA plus microneedling vs the standard regimen of hydroquinone. More importantly, patient and physician satisfaction assessments were similar between the 2 groups. Compared to hydroquinone, nightly treatment is not necessary with microneedling and TXA.²⁶

Xing et al²⁷ supported these conclusions with their study. They compared 3 study arms for a duration of 12 weeks: group A received topical 1.8% liposomal TXA BID, group B received stamp-mode electric microneedling with 5% TXA weekly, and group C applied 2% ­hydroquinone cream nightly. The study concluded that all 3 groups showed a significant reduction in mean MI by the end of the study, but a better MI improvement was observed in groups B and C (both P<.001) compared with group A (P<.01).²⁷

Zaky et al²⁸ showed that both hydroquinone and combination treatment of TXA plus microneedling are effective at improving melasma lesions. Further studies are needed to definitively conclude if combination treatment is more efficacious than hydroquinone; if the combination is more effective, it provides a treatment option for patients with melasma who may not be good candidates for hydroquinone treatment.

Study Limitations—One limitation in all the studies evaluated is the sample size. Because they all had small sample sizes, it is difficult to definitively conclude that the combination TXA and microneedling is an effective and appropriate treatment for patients with melasma. Furthermore, the quality of these studies was mostly dependent on subjectivity of the mMASI scores. Future large randomized controlled trials with a diverse participant population are needed to assess the effectiveness of TXA and microneedling in melasma treatment.

Another limitation is that many of the studies did not follow the patients longitudinally, which did not allow for an evaluation of whether patients had a relapse of melasma. Due to the chronic nature of melasma and frequent disease recurrence, future longitudinal studies are needed to monitor for disease recurrence.

Conclusion

Tranexamic acid and microneedling are potential treatment options for patients with melasma, and combination therapy appears more effective than either TXA or microneedling alone at providing sustained improvement of melasma lesions. Combination therapy appears safe and well tolerated, but its effect on reducing long-term disease recurrence is yet to be established.

Melasma (also known as chloasma faciei) is a common chronic skin disorder that results in well-demarcated, hyperpigmented, tan to dark patches that mostly appear in sun-exposed areas such as the face and neck and sometimes the arms. The exact prevalence or incidence is not known but is estimated to be 1% to 50% overall depending on the ethnic population and geographic location.^1,2 Melasma predominantly affects women, but research has shown that approximately 10% to 20% of men are affected by this condition.^3,4 Although melasma can affect patients of all skin types, it primarily affects those with darker skin tones.⁵ The groups most often affected are women of Black, Hispanic, Middle Eastern, and Southeast Asian ethnicity. Although the pathogenesis is complex and not fully understood, multiple pathways and etiologies have been theorized to cause melasma. Potential causes include exposure to UV radiation, oral contraceptives, hormonal changes, medications, thyroid dysfunction, genetics, and pregnancy.^6,7 Cytokines and growth factors, including adipokine and angiopoietin, synthesized by sebaceous glands play a role in the pathogenic mechanism of melasma. Cytokines and growth factors are hypothesized to modulate the function of melanocytes.⁸ Both melanocytes and sebocytes are controlled by α–melanocyte-stimulating hormone. Therefore, overexpression of α–melanocyte-stimulating hormone will result in overproduction of these 2 cell types, resulting in melasma. Melasma can be classified into 4 subtypes using Wood lamp examination: epidermal, dermal, mixed, or indeterminate.³ Furthermore, melasma is divided into subgroups based on the location: malar region, mandibular region, and centrofacial patch pattern.^9,10 The involvement of sebaceous glands in the pathogenesis of melasma may explain the predilection for the centrofacial region, which is the most common pattern.

The severity of melasma can be assessed using the melasma area and severity index (MASI), which is calculated by subjective assessment of 3 main factors: (1) facial area of involvement; (2) darkness of affected region; and (3) homogeneity, with the extent of melasma indicated by a score ranging from 0 to 48.¹¹ The modified MASI (mMASI) subsequently was introduced to assist with assessing the severity of melasma and creating distinct ranges for mild, moderate, and severe cases, ranging from 0 (mild) to 24 (severe).¹² Both indices are used in research to assess the improvement of melasma with treatment.

Patients with melasma report a decrease in quality of life, increased emotional stress, and lower self-esteem due to cosmesis.¹³ Treatment of melasma can be highly challenging and often is complicated by relapsing. Historically, the treatment of melasma has included the use of chemical lightening agents. Additional treatment options include the use of lasers and complex chemical peels,^9,10 but these interventions may result in adverse outcomes for individuals with darker skin tones. The current gold-standard treatment is topical hydroquinone and broad-spectrum sunscreen. Although hydroquinone is effective in the treatment of melasma, relapse is common. The goal of melasma management is not only to treat acute hyperpigmentation but also to prevent relapse. Other therapies that currently are being explored for the clinically sustained treatment of melasma include tranexamic acid (TXA)(trans-4-[aminomethyl]cyclohexanecarboxylic acid),^9,10 an antifibrinolytic agent routinely used to prevent blood loss during surgery and in the management of menorrhagia. It is a synthetic derivative of lysine and serves as a potent plasmin inhibitor by blocking the lysine-binding sites of plasminogen molecules, thus preventing the conversion of plasminogen to plasmin. It also prevents fibrinolysis and blood loss.

In addition to its hemostatic properties, TXA has been found to have hypopigmentation properties.^14,15 Plasminogen also can be found in human epidermal basal cells and human keratinocytes, and it is postulated that TXA’s interaction with these cells explains its hypopigmentation properties. Both UV radiation and hormones activate plasminogen into plasmin, resulting in the activation of tyrosinase and melanogenesis.^14,15 Tranexamic acid is postulated to inhibit the keratinocyte-plasminogen pathway, thus leading to the inhibition of UV-induced and hormone-induced pigmentation. Also, TXA serves as a competitive inhibitor for tyrosinase due to its structural similarity to tyrosine.¹⁵ The combination of these 2 mechanisms contributes to the skin-lightening effects of TXA, making it a potential treatment for melasma.

Furthermore, the use of microneedling is being explored as a treatment option for melasma. Microneedling creates microscopic punctures in the skin using tiny needles, resulting in a wound-healing response and skin resurfacing. The microneedling technique is utilized to create small holes in the skin, with needle depths that can be adjusted from 0.5 to 3.5 mm to target different layers of the dermis and allow for discreet application of TXA.¹⁶ We sought to look at the current literature on the use and effectiveness of microneedling in combination with TXA to treat melasma and prevent relapse.

Methods

A systematic review was performed of PubMed articles indexed for MEDLINE and Embase in November 2021 to compile available articles that studied TXA and microneedling as a treatment for melasma. The PubMed search terms were (melasma) AND (microneedling* OR ‘tranexamic acid’ OR TXA or TA). The Embase search terms were (cholasma OR melasma) AND (tranexamic acid OR TXA) AND (microneedling)(Figure). The search was then limited to ”randomized controlled trial” and ”clinical trial” in English-language journals. Duplicates were excluded. After thorough evaluation, articles that discussed the use of TXA in combination with treatment options other than microneedling also were excluded.

Results

The literature search yielded a total of 12 articles that assessed the effectiveness of TXA and microneedling for the treatment of melasma (Table).^17-28 Several articles concluded that TXA was equally effective at reducing melasma lesions when compared with the standard treatment of hydroquinone. Some of the reviewed articles also demonstrated the effectiveness of microneedling in improving melasma lesions as a stand-alone treatment. These studies highlighted the enhanced efficacy of the combined treatment of TXA and microneedling compared with their individual uses.^17-28

Comment

Melasma is a common chronic hyperpigmentation disorder, making its treatment clinically challenging. Many patients experience symptom relapses, and limited effective treatment options make achieving complete clearance difficult, underscoring the need for improved therapeutic approaches. Recently, researchers have explored alternative treatments to address the challenges of melasma management. Tranexamic acid is an antifibrinolytic used to prevent blood loss and has emerged as a potential treatment for melasma. Similarly, microneedling—a technique in which multiple punctures are made in the skin to activate and stimulate wound healing and skin rejuvenation—shows promise for melasma.

Oral TXA for Melasma—Oral TXA has been shown to reduce melasma lesions. Del Rosario et al¹⁷ recruited 44 women (39 of whom completed the study) with moderate to severe melasma and randomized them into 2 groups: oral TXA and placebo. This study demonstrated a 49% reduction in the mMASI score in all participants taking oral TXA (250 mg twice daily [BID]) compared with an 18% reduction in the control group (placebo capsule BID) after 3 months of treatment. In patients with moderate and severe melasma, 45% and 51% mMASI score reductions were reported in the treatment group, respectively, vs 16% and 19% score reductions in placebo group, respectively. These researchers concluded that oral TXA may be effective at treating moderate to severe melasma. Although patients with severe melasma had a better response to treatment, their improvement was not sustained compared with patients with moderate melasma after a 3-month posttreatment follow-up.¹⁷

Microneedling Plus TXA for Melasma—Microneedling alone has been shown to be effective for melasma. El Attar et al¹⁸ conducted a split-face study of microneedling (1.5-mm depth) plus topical TXA (0.5 mL)(right side of the face[treatment arm]) compared with microneedling (1.5-mm depth) plus topical vitamin C (0.5 mL)(left side of the face [control group]) in 20 women with melasma. The sessions were repeated every 2 weeks for a total of 6 sessions. Although researchers found no statistically significant differences between the 2 treatment sides, microneedling plus TXA showed a slight advantage over microneedling plus vitamin C in dermoscopic examination. Both sides showed improvement in pigmented lesions, but vitamin C–treated lesions did not show an improvement in vascularity vs TXA.¹⁸

Saleh et al¹⁹ further showed that combination treatment with microneedling and TXA may improve clinical outcomes better than microneedling alone. Their study demonstrated a reduction in MASI score that was significantly higher in the combination treatment group compared with the microneedling alone group (P=.001). There was a significant reduction in melanoma antigen recognized by T cells 1 (MART-1)–positive cells in the combination treatment group compared with the microneedling alone group (P=.001). Lastly, combined therapy improved melasma patches better than microneedling alone.¹⁹

Xu et al²⁰ conducted a split-face study (N=28) exploring the effectiveness of transdermal application of topical TXA using a microarray pen with microneedles (vibration at 3000×/min) plus topical TXA on one side of the face, while the other side received only topical TXA as a control. After 12 weeks of treatment, combination therapy with microneedling and TXA decreased brown spot scores, lowered melanin index (MI) values, improved blinded physician assessment, and improved patient satisfaction vs TXA therapy alone.²⁰

Kaur et al²¹ conducted a split-face, randomized, controlled trial of microneedling (1-mm depth) with TXA solution 10% vs microneedling (1-mm depth) with distilled water alone for 8 weeks (N=40). They graded participant responses to treatment using reductions in mMASI scores¹² at every 2 weeks of follow-up (no response, minimal or poor response=0%–25%; partial or fair response=26%–50%; good response=51%–75%; and excellent response=>75%). They reported an overall reduction in mMASI scores for both the treatment side and the control side in all participants, showing a 65.92% improvement in mean mMASI scores on the treatment side vs 20.75% improvement on the control side at week 8. Both sides showed statistically significant reductions in mean mMASI scores (P<.05). Clinically, 40% (16/40) of participants showed an excellent response to combined treatment compared with 0% (0/40) to microneedling alone. Overall, patient satisfaction was similar across both groups. This study demonstrated that microneedling alone improves melasma, but a combination of microneedling plus TXA showed a better clinical reduction in melasma. However, the researchers did not follow up with participants posttreatment, so it remains unclear if the improved clinical outcomes were sustained long-term.²¹

Ebrahim et al²² reported that the combination of 0.5 mL TXA (4 mg/mL) and microneedling (0.25- to 1-mm depth) was effective for melasma. Although there was improvement within microneedling and TXA, the study also showed that intradermal injection of TXA was significant in reducing mean mMASI scores and improving melasma (P<.001). The reduction in mMASI scores for the group receiving intradermal injections of TXA (left side; 74.8% reduction in mean mMASI score) vs the group receiving microneedling application of TXA (right side; 73.6% reduction in mean mMASI score) was not statistically significant. These findings suggest that the mode of TXA application may not be critical in determining clinical responses to TXA treatment. Although there was no reported statistically significant difference in clinical outcomes between the 2 treatments, patient satisfaction was higher on the microneedling side. Only 8 of 50 participants (16%) experienced recurrence 3 months posttreatment.²²

Saki et al²³ compared the efficacy of topical hydroquinone (2%) to intradermal TXA injections in treating melasma. They found intradermal TXA injections to be a clinically effective mode of treatment.²³

Sharma et al²⁴ explored the efficacy and safety of oral TXA by randomly assigning 100 Indian patients (20 of whom withdrew before study completion) with melasma into 2 groups: group A received TXA 250 mg twice daily, and group B received intradermal microinjections of TXA (4 mg/mL) every 4 weeks. The MASI scores were assessed at 4-week intervals for a total of 12 weeks. There was a decrease in MASI scores in both groups, and there was no statistically significant difference in mean percentage reduction in MASI scores between the 2 routes of drug administration, further suggesting the effectiveness of TXA independent of administration route. Two patients in group A relapsed at 24 weeks, and there were no relapses in group B, which may suggest a minimal superiority of TXA plus microneedling at providing more sustainable results compared with oral TXA alone. A notable limitation of this study was a high dropout rate as well as lack of long-term follow-up with participants, limiting the generalizability of the conclusions.²⁴

Cassiano et al²⁵ assigned 64 women with melasma to 1 of 3 treatment groups or a control group to compare the effectiveness of microneedling (M group: 1.5 mm; 2 sessions), oral TXA (T group: 250 mg/d twice daily for 60 days), and a combination of microneedling (2 sessions) and oral TXA (MT group: 250 mg/d twice daily for 60 days)with placebo for clinically reducing melasma lesions. The intervention period was 60 days followed by a 60-day maintenance phase for a total study period of 120 days. The researchers evaluated mMASI scores, quality of life, and difference in colorimetric luminosity. All treatment groups showed a reduction in mMASI scores at both 30 days and 60 days, indicating improved melasma severity. The MT and T groups had more significant improvement at 30 days compared with the control group (P<.03), suggesting that microneedling plus TXA and TXA alone promote faster improvement in melasma lesions. By 60 days, the M, T, and MT groups outperformed the control group, with no significant differences between the M, T, and MT groups. However, at the 120-day maintenance follow-up, the T group did not maintain its improvement compared with the control group. The M and MT groups showed no significance difference in effectiveness at 120 days, suggesting that microneedling may promote less frequent relapse and sustained remission compared to TXA alone.²⁵

Hydroquinone for Melasma—Additional studies on the use of TXA treatments show that TXA may be an equally effective alternative to the standard use of hydroquinone treatment. Shamsi Meymandi et al²⁶ did not find a statistically significant difference in treatment with TXA plus microneedling vs the standard regimen of hydroquinone. More importantly, patient and physician satisfaction assessments were similar between the 2 groups. Compared to hydroquinone, nightly treatment is not necessary with microneedling and TXA.²⁶

Xing et al²⁷ supported these conclusions with their study. They compared 3 study arms for a duration of 12 weeks: group A received topical 1.8% liposomal TXA BID, group B received stamp-mode electric microneedling with 5% TXA weekly, and group C applied 2% ­hydroquinone cream nightly. The study concluded that all 3 groups showed a significant reduction in mean MI by the end of the study, but a better MI improvement was observed in groups B and C (both P<.001) compared with group A (P<.01).²⁷

Zaky et al²⁸ showed that both hydroquinone and combination treatment of TXA plus microneedling are effective at improving melasma lesions. Further studies are needed to definitively conclude if combination treatment is more efficacious than hydroquinone; if the combination is more effective, it provides a treatment option for patients with melasma who may not be good candidates for hydroquinone treatment.

Study Limitations—One limitation in all the studies evaluated is the sample size. Because they all had small sample sizes, it is difficult to definitively conclude that the combination TXA and microneedling is an effective and appropriate treatment for patients with melasma. Furthermore, the quality of these studies was mostly dependent on subjectivity of the mMASI scores. Future large randomized controlled trials with a diverse participant population are needed to assess the effectiveness of TXA and microneedling in melasma treatment.

Another limitation is that many of the studies did not follow the patients longitudinally, which did not allow for an evaluation of whether patients had a relapse of melasma. Due to the chronic nature of melasma and frequent disease recurrence, future longitudinal studies are needed to monitor for disease recurrence.

Conclusion

Tranexamic acid and microneedling are potential treatment options for patients with melasma, and combination therapy appears more effective than either TXA or microneedling alone at providing sustained improvement of melasma lesions. Combination therapy appears safe and well tolerated, but its effect on reducing long-term disease recurrence is yet to be established.

Melasma (also known as chloasma faciei) is a common chronic skin disorder that results in well-demarcated, hyperpigmented, tan to dark patches that mostly appear in sun-exposed areas such as the face and neck and sometimes the arms. The exact prevalence or incidence is not known but is estimated to be 1% to 50% overall depending on the ethnic population and geographic location.^1,2 Melasma predominantly affects women, but research has shown that approximately 10% to 20% of men are affected by this condition.^3,4 Although melasma can affect patients of all skin types, it primarily affects those with darker skin tones.⁵ The groups most often affected are women of Black, Hispanic, Middle Eastern, and Southeast Asian ethnicity. Although the pathogenesis is complex and not fully understood, multiple pathways and etiologies have been theorized to cause melasma. Potential causes include exposure to UV radiation, oral contraceptives, hormonal changes, medications, thyroid dysfunction, genetics, and pregnancy.^6,7 Cytokines and growth factors, including adipokine and angiopoietin, synthesized by sebaceous glands play a role in the pathogenic mechanism of melasma. Cytokines and growth factors are hypothesized to modulate the function of melanocytes.⁸ Both melanocytes and sebocytes are controlled by α–melanocyte-stimulating hormone. Therefore, overexpression of α–melanocyte-stimulating hormone will result in overproduction of these 2 cell types, resulting in melasma. Melasma can be classified into 4 subtypes using Wood lamp examination: epidermal, dermal, mixed, or indeterminate.³ Furthermore, melasma is divided into subgroups based on the location: malar region, mandibular region, and centrofacial patch pattern.^9,10 The involvement of sebaceous glands in the pathogenesis of melasma may explain the predilection for the centrofacial region, which is the most common pattern.

The severity of melasma can be assessed using the melasma area and severity index (MASI), which is calculated by subjective assessment of 3 main factors: (1) facial area of involvement; (2) darkness of affected region; and (3) homogeneity, with the extent of melasma indicated by a score ranging from 0 to 48.¹¹ The modified MASI (mMASI) subsequently was introduced to assist with assessing the severity of melasma and creating distinct ranges for mild, moderate, and severe cases, ranging from 0 (mild) to 24 (severe).¹² Both indices are used in research to assess the improvement of melasma with treatment.

Patients with melasma report a decrease in quality of life, increased emotional stress, and lower self-esteem due to cosmesis.¹³ Treatment of melasma can be highly challenging and often is complicated by relapsing. Historically, the treatment of melasma has included the use of chemical lightening agents. Additional treatment options include the use of lasers and complex chemical peels,^9,10 but these interventions may result in adverse outcomes for individuals with darker skin tones. The current gold-standard treatment is topical hydroquinone and broad-spectrum sunscreen. Although hydroquinone is effective in the treatment of melasma, relapse is common. The goal of melasma management is not only to treat acute hyperpigmentation but also to prevent relapse. Other therapies that currently are being explored for the clinically sustained treatment of melasma include tranexamic acid (TXA)(trans-4-[aminomethyl]cyclohexanecarboxylic acid),^9,10 an antifibrinolytic agent routinely used to prevent blood loss during surgery and in the management of menorrhagia. It is a synthetic derivative of lysine and serves as a potent plasmin inhibitor by blocking the lysine-binding sites of plasminogen molecules, thus preventing the conversion of plasminogen to plasmin. It also prevents fibrinolysis and blood loss.

In addition to its hemostatic properties, TXA has been found to have hypopigmentation properties.^14,15 Plasminogen also can be found in human epidermal basal cells and human keratinocytes, and it is postulated that TXA’s interaction with these cells explains its hypopigmentation properties. Both UV radiation and hormones activate plasminogen into plasmin, resulting in the activation of tyrosinase and melanogenesis.^14,15 Tranexamic acid is postulated to inhibit the keratinocyte-plasminogen pathway, thus leading to the inhibition of UV-induced and hormone-induced pigmentation. Also, TXA serves as a competitive inhibitor for tyrosinase due to its structural similarity to tyrosine.¹⁵ The combination of these 2 mechanisms contributes to the skin-lightening effects of TXA, making it a potential treatment for melasma.

Furthermore, the use of microneedling is being explored as a treatment option for melasma. Microneedling creates microscopic punctures in the skin using tiny needles, resulting in a wound-healing response and skin resurfacing. The microneedling technique is utilized to create small holes in the skin, with needle depths that can be adjusted from 0.5 to 3.5 mm to target different layers of the dermis and allow for discreet application of TXA.¹⁶ We sought to look at the current literature on the use and effectiveness of microneedling in combination with TXA to treat melasma and prevent relapse.

Methods

A systematic review was performed of PubMed articles indexed for MEDLINE and Embase in November 2021 to compile available articles that studied TXA and microneedling as a treatment for melasma. The PubMed search terms were (melasma) AND (microneedling* OR ‘tranexamic acid’ OR TXA or TA). The Embase search terms were (cholasma OR melasma) AND (tranexamic acid OR TXA) AND (microneedling)(Figure). The search was then limited to ”randomized controlled trial” and ”clinical trial” in English-language journals. Duplicates were excluded. After thorough evaluation, articles that discussed the use of TXA in combination with treatment options other than microneedling also were excluded.

Results

The literature search yielded a total of 12 articles that assessed the effectiveness of TXA and microneedling for the treatment of melasma (Table).^17-28 Several articles concluded that TXA was equally effective at reducing melasma lesions when compared with the standard treatment of hydroquinone. Some of the reviewed articles also demonstrated the effectiveness of microneedling in improving melasma lesions as a stand-alone treatment. These studies highlighted the enhanced efficacy of the combined treatment of TXA and microneedling compared with their individual uses.^17-28

Comment

Melasma is a common chronic hyperpigmentation disorder, making its treatment clinically challenging. Many patients experience symptom relapses, and limited effective treatment options make achieving complete clearance difficult, underscoring the need for improved therapeutic approaches. Recently, researchers have explored alternative treatments to address the challenges of melasma management. Tranexamic acid is an antifibrinolytic used to prevent blood loss and has emerged as a potential treatment for melasma. Similarly, microneedling—a technique in which multiple punctures are made in the skin to activate and stimulate wound healing and skin rejuvenation—shows promise for melasma.

Oral TXA for Melasma—Oral TXA has been shown to reduce melasma lesions. Del Rosario et al¹⁷ recruited 44 women (39 of whom completed the study) with moderate to severe melasma and randomized them into 2 groups: oral TXA and placebo. This study demonstrated a 49% reduction in the mMASI score in all participants taking oral TXA (250 mg twice daily [BID]) compared with an 18% reduction in the control group (placebo capsule BID) after 3 months of treatment. In patients with moderate and severe melasma, 45% and 51% mMASI score reductions were reported in the treatment group, respectively, vs 16% and 19% score reductions in placebo group, respectively. These researchers concluded that oral TXA may be effective at treating moderate to severe melasma. Although patients with severe melasma had a better response to treatment, their improvement was not sustained compared with patients with moderate melasma after a 3-month posttreatment follow-up.¹⁷

Microneedling Plus TXA for Melasma—Microneedling alone has been shown to be effective for melasma. El Attar et al¹⁸ conducted a split-face study of microneedling (1.5-mm depth) plus topical TXA (0.5 mL)(right side of the face[treatment arm]) compared with microneedling (1.5-mm depth) plus topical vitamin C (0.5 mL)(left side of the face [control group]) in 20 women with melasma. The sessions were repeated every 2 weeks for a total of 6 sessions. Although researchers found no statistically significant differences between the 2 treatment sides, microneedling plus TXA showed a slight advantage over microneedling plus vitamin C in dermoscopic examination. Both sides showed improvement in pigmented lesions, but vitamin C–treated lesions did not show an improvement in vascularity vs TXA.¹⁸

Saleh et al¹⁹ further showed that combination treatment with microneedling and TXA may improve clinical outcomes better than microneedling alone. Their study demonstrated a reduction in MASI score that was significantly higher in the combination treatment group compared with the microneedling alone group (P=.001). There was a significant reduction in melanoma antigen recognized by T cells 1 (MART-1)–positive cells in the combination treatment group compared with the microneedling alone group (P=.001). Lastly, combined therapy improved melasma patches better than microneedling alone.¹⁹

Xu et al²⁰ conducted a split-face study (N=28) exploring the effectiveness of transdermal application of topical TXA using a microarray pen with microneedles (vibration at 3000×/min) plus topical TXA on one side of the face, while the other side received only topical TXA as a control. After 12 weeks of treatment, combination therapy with microneedling and TXA decreased brown spot scores, lowered melanin index (MI) values, improved blinded physician assessment, and improved patient satisfaction vs TXA therapy alone.²⁰

Kaur et al²¹ conducted a split-face, randomized, controlled trial of microneedling (1-mm depth) with TXA solution 10% vs microneedling (1-mm depth) with distilled water alone for 8 weeks (N=40). They graded participant responses to treatment using reductions in mMASI scores¹² at every 2 weeks of follow-up (no response, minimal or poor response=0%–25%; partial or fair response=26%–50%; good response=51%–75%; and excellent response=>75%). They reported an overall reduction in mMASI scores for both the treatment side and the control side in all participants, showing a 65.92% improvement in mean mMASI scores on the treatment side vs 20.75% improvement on the control side at week 8. Both sides showed statistically significant reductions in mean mMASI scores (P<.05). Clinically, 40% (16/40) of participants showed an excellent response to combined treatment compared with 0% (0/40) to microneedling alone. Overall, patient satisfaction was similar across both groups. This study demonstrated that microneedling alone improves melasma, but a combination of microneedling plus TXA showed a better clinical reduction in melasma. However, the researchers did not follow up with participants posttreatment, so it remains unclear if the improved clinical outcomes were sustained long-term.²¹

Ebrahim et al²² reported that the combination of 0.5 mL TXA (4 mg/mL) and microneedling (0.25- to 1-mm depth) was effective for melasma. Although there was improvement within microneedling and TXA, the study also showed that intradermal injection of TXA was significant in reducing mean mMASI scores and improving melasma (P<.001). The reduction in mMASI scores for the group receiving intradermal injections of TXA (left side; 74.8% reduction in mean mMASI score) vs the group receiving microneedling application of TXA (right side; 73.6% reduction in mean mMASI score) was not statistically significant. These findings suggest that the mode of TXA application may not be critical in determining clinical responses to TXA treatment. Although there was no reported statistically significant difference in clinical outcomes between the 2 treatments, patient satisfaction was higher on the microneedling side. Only 8 of 50 participants (16%) experienced recurrence 3 months posttreatment.²²

Saki et al²³ compared the efficacy of topical hydroquinone (2%) to intradermal TXA injections in treating melasma. They found intradermal TXA injections to be a clinically effective mode of treatment.²³

Sharma et al²⁴ explored the efficacy and safety of oral TXA by randomly assigning 100 Indian patients (20 of whom withdrew before study completion) with melasma into 2 groups: group A received TXA 250 mg twice daily, and group B received intradermal microinjections of TXA (4 mg/mL) every 4 weeks. The MASI scores were assessed at 4-week intervals for a total of 12 weeks. There was a decrease in MASI scores in both groups, and there was no statistically significant difference in mean percentage reduction in MASI scores between the 2 routes of drug administration, further suggesting the effectiveness of TXA independent of administration route. Two patients in group A relapsed at 24 weeks, and there were no relapses in group B, which may suggest a minimal superiority of TXA plus microneedling at providing more sustainable results compared with oral TXA alone. A notable limitation of this study was a high dropout rate as well as lack of long-term follow-up with participants, limiting the generalizability of the conclusions.²⁴

Cassiano et al²⁵ assigned 64 women with melasma to 1 of 3 treatment groups or a control group to compare the effectiveness of microneedling (M group: 1.5 mm; 2 sessions), oral TXA (T group: 250 mg/d twice daily for 60 days), and a combination of microneedling (2 sessions) and oral TXA (MT group: 250 mg/d twice daily for 60 days)with placebo for clinically reducing melasma lesions. The intervention period was 60 days followed by a 60-day maintenance phase for a total study period of 120 days. The researchers evaluated mMASI scores, quality of life, and difference in colorimetric luminosity. All treatment groups showed a reduction in mMASI scores at both 30 days and 60 days, indicating improved melasma severity. The MT and T groups had more significant improvement at 30 days compared with the control group (P<.03), suggesting that microneedling plus TXA and TXA alone promote faster improvement in melasma lesions. By 60 days, the M, T, and MT groups outperformed the control group, with no significant differences between the M, T, and MT groups. However, at the 120-day maintenance follow-up, the T group did not maintain its improvement compared with the control group. The M and MT groups showed no significance difference in effectiveness at 120 days, suggesting that microneedling may promote less frequent relapse and sustained remission compared to TXA alone.²⁵

Hydroquinone for Melasma—Additional studies on the use of TXA treatments show that TXA may be an equally effective alternative to the standard use of hydroquinone treatment. Shamsi Meymandi et al²⁶ did not find a statistically significant difference in treatment with TXA plus microneedling vs the standard regimen of hydroquinone. More importantly, patient and physician satisfaction assessments were similar between the 2 groups. Compared to hydroquinone, nightly treatment is not necessary with microneedling and TXA.²⁶

Xing et al²⁷ supported these conclusions with their study. They compared 3 study arms for a duration of 12 weeks: group A received topical 1.8% liposomal TXA BID, group B received stamp-mode electric microneedling with 5% TXA weekly, and group C applied 2% ­hydroquinone cream nightly. The study concluded that all 3 groups showed a significant reduction in mean MI by the end of the study, but a better MI improvement was observed in groups B and C (both P<.001) compared with group A (P<.01).²⁷

Zaky et al²⁸ showed that both hydroquinone and combination treatment of TXA plus microneedling are effective at improving melasma lesions. Further studies are needed to definitively conclude if combination treatment is more efficacious than hydroquinone; if the combination is more effective, it provides a treatment option for patients with melasma who may not be good candidates for hydroquinone treatment.

Study Limitations—One limitation in all the studies evaluated is the sample size. Because they all had small sample sizes, it is difficult to definitively conclude that the combination TXA and microneedling is an effective and appropriate treatment for patients with melasma. Furthermore, the quality of these studies was mostly dependent on subjectivity of the mMASI scores. Future large randomized controlled trials with a diverse participant population are needed to assess the effectiveness of TXA and microneedling in melasma treatment.

Another limitation is that many of the studies did not follow the patients longitudinally, which did not allow for an evaluation of whether patients had a relapse of melasma. Due to the chronic nature of melasma and frequent disease recurrence, future longitudinal studies are needed to monitor for disease recurrence.

Conclusion

Tranexamic acid and microneedling are potential treatment options for patients with melasma, and combination therapy appears more effective than either TXA or microneedling alone at providing sustained improvement of melasma lesions. Combination therapy appears safe and well tolerated, but its effect on reducing long-term disease recurrence is yet to be established.

Click to view more from Federal Health Care Data Trends 2024.

Click to view more from Federal Health Care Data Trends 2024.

Click to view more from Federal Health Care Data Trends 2024.

Only one third of pediatric patients were correctly triaged at emergency departments (EDs) in a northern California health care system, according to a multicenter retrospective study published in JAMA Pediatrics. Researchers also identified gender, age, race, ethnicity, and comorbidity disparities in those who were undertriaged.

The researchers found that only 34.1% of visits were correctly triaged while 58.5% were overtriaged and 7.4% were undertriaged. The findings were based on analysis of more than 1 million pediatric emergency visits over a 5-year period that used the Emergency Severity Index (ESI) version 4 for triage.

“The ESI had poor sensitivity in identifying a critically ill pediatric patient, and undertriage occurred in 1 in 14 children,” wrote Dana R. Sax, MD, a senior emergency physician at The Permanente Medical Group in northern California, and her colleagues.

Disparities in Emergency Care

The results underscore the need for more work to address disparities in emergency care, wrote Warren D. Frankenberger, PhD, RN, a nurse scientist at Children’s Hospital of Philadelphia, and two colleagues in an accompanying editorial.

“Decisions in triage can have significant downstream effects on subsequent care during the ED visit,” they wrote in their editorial. “Given that the triage process in most instances is fully executed by nurses, nurse researchers are in a key position to evaluate these and other covariates to influence further improvements in triage.” They suggested that use of clinical decision support tools and artificial intelligence (AI) may improve the triage process, albeit with the caveat that AI often relies on models with pre-existing historical bias that may perpetuate structural inequalities.
 

Study Methodology

The researchers analyzed 1,016,816 pediatric visits at 21 emergency departments in Kaiser Permanente Northern California between January 2016 and December 2020. The patients were an average 7 years old, and 47% were female. The researchers excluded visits that lacked ESI data or had incomplete ED time variables as well as those with patients who left against medical advice, were not seen, or were transferred from another ED.

The study relied on novel definitions of ESI undertriage and overtriage developed through a modified Delphi process by a team of four emergency physicians, one pediatric emergency physician, two emergency nurses, and one pediatric ICU physician. The definition involved comparing ESI levels to the clinical outcomes and resource use.

Resources included laboratory analysis, electrocardiography, radiography, CT, MRI, diagnostic ultrasonography (not point of care), angiography, IV fluids, and IV, intramuscular, or nebulized medications. Resources did not include “oral medications, tetanus immunizations, point-of-care testing, history and physical examination, saline or heparin lock, prescription refills, simple wound care, crutches, splints, and slings.”

Level 1 events were those requiring time-sensitive, critical intervention, including high-risk sepsis. Level 2 events included most level 1 events that occurred after the first hour (except operating room admission or hospital transfer) as well as respiratory therapy, toxicology consult, lumbar puncture, suicidality as chief concern, at least 2 doses of albuterol or continuous albuterol nebulization, a skeletal survey x-ray order, and medical social work consult with an ED length of stay of at least 2 hours. Level 3 events included IV mediation order, any CT order, OR admission or hospital transfer after one hour, or any pediatric hospitalist consult.
 

Analyzing the ED Visits

Overtriaged cases were ESI level 1 or 2 cases in which fewer than 2 resources were used; level 3 cases where fewer than 2 resources were used and no level 1 or 2 events occurred; and level 4 cases where no resources were used.

Undertriaged cases were defined as the following:

• ESI level 5 cases where any resource was used and any level 1, 2, or 3 events occurred.
• Level 4 cases where more than 1 resource was used and any level 1, 2, or 3 events occurred.
• Level 3 cases where any level 1 event occurred, more than one level 2 event occurred, or any level 2 event occurred and more than one additional ED resource type was used.
• Level 2 cases where any level 1 event occurred.

About half the visits (51%) were assigned ESI 3, which was the category with the highest proportion of mistriage. After adjusting for study facility and triage vital signs, the researchers found that children age 6 and older were more likely to be undertriaged than those younger than 6, particularly those age 15 and older (relative risk [RR], 1.36).

Undertriage was also modestly more likely with male patients (female patients’ RR, 0.93), patients with comorbidities (RR, 1.11-1.2), patients who arrived by ambulance (RR, 1.04), and patients who were Asian (RR, 1.10), Black (RR, 1.05), or Hispanic (RR, 1.04). Undertriage became gradually less likely with each additional year in the study period, with an RR of 0.89 in 2019 and 2020.

Among the study’s limitations were use of ESI version 4, instead of the currently used 5, and the omission of common procedures from the outcome definition that “may systematically bias the analysis toward overtriage,” the editorial noted. The authors also did not include pain as a variable in the analysis, which can often indicate patient acuity.

Further, this study was unable to include covariates identified in other research that may influence clinical decision-making, such as “the presenting illness or injury, children with complex medical needs, and language proficiency,” Dr. Frankenberger and colleagues wrote. “Furthermore, environmental stressors, such as ED volume and crowding, can influence how a nurse prioritizes care and may increase bias in decision-making and/or increase practice variability.”

The study was funded by the Kaiser Permanente Northern California (KPNC) Community Health program. One author had consulting payments from CSL Behring and Abbott Point-of-Care, and six of the authors have received grant funding from the KPNC Community Health program. The editorial authors reported no conflicts of interest.

Only one third of pediatric patients were correctly triaged at emergency departments (EDs) in a northern California health care system, according to a multicenter retrospective study published in JAMA Pediatrics. Researchers also identified gender, age, race, ethnicity, and comorbidity disparities in those who were undertriaged.

The researchers found that only 34.1% of visits were correctly triaged while 58.5% were overtriaged and 7.4% were undertriaged. The findings were based on analysis of more than 1 million pediatric emergency visits over a 5-year period that used the Emergency Severity Index (ESI) version 4 for triage.

“The ESI had poor sensitivity in identifying a critically ill pediatric patient, and undertriage occurred in 1 in 14 children,” wrote Dana R. Sax, MD, a senior emergency physician at The Permanente Medical Group in northern California, and her colleagues.

Disparities in Emergency Care

The results underscore the need for more work to address disparities in emergency care, wrote Warren D. Frankenberger, PhD, RN, a nurse scientist at Children’s Hospital of Philadelphia, and two colleagues in an accompanying editorial.

“Decisions in triage can have significant downstream effects on subsequent care during the ED visit,” they wrote in their editorial. “Given that the triage process in most instances is fully executed by nurses, nurse researchers are in a key position to evaluate these and other covariates to influence further improvements in triage.” They suggested that use of clinical decision support tools and artificial intelligence (AI) may improve the triage process, albeit with the caveat that AI often relies on models with pre-existing historical bias that may perpetuate structural inequalities.
 

Study Methodology

The researchers analyzed 1,016,816 pediatric visits at 21 emergency departments in Kaiser Permanente Northern California between January 2016 and December 2020. The patients were an average 7 years old, and 47% were female. The researchers excluded visits that lacked ESI data or had incomplete ED time variables as well as those with patients who left against medical advice, were not seen, or were transferred from another ED.

The study relied on novel definitions of ESI undertriage and overtriage developed through a modified Delphi process by a team of four emergency physicians, one pediatric emergency physician, two emergency nurses, and one pediatric ICU physician. The definition involved comparing ESI levels to the clinical outcomes and resource use.

Resources included laboratory analysis, electrocardiography, radiography, CT, MRI, diagnostic ultrasonography (not point of care), angiography, IV fluids, and IV, intramuscular, or nebulized medications. Resources did not include “oral medications, tetanus immunizations, point-of-care testing, history and physical examination, saline or heparin lock, prescription refills, simple wound care, crutches, splints, and slings.”

Level 1 events were those requiring time-sensitive, critical intervention, including high-risk sepsis. Level 2 events included most level 1 events that occurred after the first hour (except operating room admission or hospital transfer) as well as respiratory therapy, toxicology consult, lumbar puncture, suicidality as chief concern, at least 2 doses of albuterol or continuous albuterol nebulization, a skeletal survey x-ray order, and medical social work consult with an ED length of stay of at least 2 hours. Level 3 events included IV mediation order, any CT order, OR admission or hospital transfer after one hour, or any pediatric hospitalist consult.
 

Analyzing the ED Visits

Overtriaged cases were ESI level 1 or 2 cases in which fewer than 2 resources were used; level 3 cases where fewer than 2 resources were used and no level 1 or 2 events occurred; and level 4 cases where no resources were used.

Undertriaged cases were defined as the following:

• ESI level 5 cases where any resource was used and any level 1, 2, or 3 events occurred.
• Level 4 cases where more than 1 resource was used and any level 1, 2, or 3 events occurred.
• Level 3 cases where any level 1 event occurred, more than one level 2 event occurred, or any level 2 event occurred and more than one additional ED resource type was used.
• Level 2 cases where any level 1 event occurred.

About half the visits (51%) were assigned ESI 3, which was the category with the highest proportion of mistriage. After adjusting for study facility and triage vital signs, the researchers found that children age 6 and older were more likely to be undertriaged than those younger than 6, particularly those age 15 and older (relative risk [RR], 1.36).

Undertriage was also modestly more likely with male patients (female patients’ RR, 0.93), patients with comorbidities (RR, 1.11-1.2), patients who arrived by ambulance (RR, 1.04), and patients who were Asian (RR, 1.10), Black (RR, 1.05), or Hispanic (RR, 1.04). Undertriage became gradually less likely with each additional year in the study period, with an RR of 0.89 in 2019 and 2020.

Among the study’s limitations were use of ESI version 4, instead of the currently used 5, and the omission of common procedures from the outcome definition that “may systematically bias the analysis toward overtriage,” the editorial noted. The authors also did not include pain as a variable in the analysis, which can often indicate patient acuity.

Further, this study was unable to include covariates identified in other research that may influence clinical decision-making, such as “the presenting illness or injury, children with complex medical needs, and language proficiency,” Dr. Frankenberger and colleagues wrote. “Furthermore, environmental stressors, such as ED volume and crowding, can influence how a nurse prioritizes care and may increase bias in decision-making and/or increase practice variability.”

The study was funded by the Kaiser Permanente Northern California (KPNC) Community Health program. One author had consulting payments from CSL Behring and Abbott Point-of-Care, and six of the authors have received grant funding from the KPNC Community Health program. The editorial authors reported no conflicts of interest.

Only one third of pediatric patients were correctly triaged at emergency departments (EDs) in a northern California health care system, according to a multicenter retrospective study published in JAMA Pediatrics. Researchers also identified gender, age, race, ethnicity, and comorbidity disparities in those who were undertriaged.

The researchers found that only 34.1% of visits were correctly triaged while 58.5% were overtriaged and 7.4% were undertriaged. The findings were based on analysis of more than 1 million pediatric emergency visits over a 5-year period that used the Emergency Severity Index (ESI) version 4 for triage.

“The ESI had poor sensitivity in identifying a critically ill pediatric patient, and undertriage occurred in 1 in 14 children,” wrote Dana R. Sax, MD, a senior emergency physician at The Permanente Medical Group in northern California, and her colleagues.

Disparities in Emergency Care

The results underscore the need for more work to address disparities in emergency care, wrote Warren D. Frankenberger, PhD, RN, a nurse scientist at Children’s Hospital of Philadelphia, and two colleagues in an accompanying editorial.

“Decisions in triage can have significant downstream effects on subsequent care during the ED visit,” they wrote in their editorial. “Given that the triage process in most instances is fully executed by nurses, nurse researchers are in a key position to evaluate these and other covariates to influence further improvements in triage.” They suggested that use of clinical decision support tools and artificial intelligence (AI) may improve the triage process, albeit with the caveat that AI often relies on models with pre-existing historical bias that may perpetuate structural inequalities.
 

Study Methodology

The researchers analyzed 1,016,816 pediatric visits at 21 emergency departments in Kaiser Permanente Northern California between January 2016 and December 2020. The patients were an average 7 years old, and 47% were female. The researchers excluded visits that lacked ESI data or had incomplete ED time variables as well as those with patients who left against medical advice, were not seen, or were transferred from another ED.

The study relied on novel definitions of ESI undertriage and overtriage developed through a modified Delphi process by a team of four emergency physicians, one pediatric emergency physician, two emergency nurses, and one pediatric ICU physician. The definition involved comparing ESI levels to the clinical outcomes and resource use.

Resources included laboratory analysis, electrocardiography, radiography, CT, MRI, diagnostic ultrasonography (not point of care), angiography, IV fluids, and IV, intramuscular, or nebulized medications. Resources did not include “oral medications, tetanus immunizations, point-of-care testing, history and physical examination, saline or heparin lock, prescription refills, simple wound care, crutches, splints, and slings.”

Level 1 events were those requiring time-sensitive, critical intervention, including high-risk sepsis. Level 2 events included most level 1 events that occurred after the first hour (except operating room admission or hospital transfer) as well as respiratory therapy, toxicology consult, lumbar puncture, suicidality as chief concern, at least 2 doses of albuterol or continuous albuterol nebulization, a skeletal survey x-ray order, and medical social work consult with an ED length of stay of at least 2 hours. Level 3 events included IV mediation order, any CT order, OR admission or hospital transfer after one hour, or any pediatric hospitalist consult.
 

Analyzing the ED Visits

Overtriaged cases were ESI level 1 or 2 cases in which fewer than 2 resources were used; level 3 cases where fewer than 2 resources were used and no level 1 or 2 events occurred; and level 4 cases where no resources were used.

Undertriaged cases were defined as the following:

• ESI level 5 cases where any resource was used and any level 1, 2, or 3 events occurred.
• Level 4 cases where more than 1 resource was used and any level 1, 2, or 3 events occurred.
• Level 3 cases where any level 1 event occurred, more than one level 2 event occurred, or any level 2 event occurred and more than one additional ED resource type was used.
• Level 2 cases where any level 1 event occurred.

About half the visits (51%) were assigned ESI 3, which was the category with the highest proportion of mistriage. After adjusting for study facility and triage vital signs, the researchers found that children age 6 and older were more likely to be undertriaged than those younger than 6, particularly those age 15 and older (relative risk [RR], 1.36).

Undertriage was also modestly more likely with male patients (female patients’ RR, 0.93), patients with comorbidities (RR, 1.11-1.2), patients who arrived by ambulance (RR, 1.04), and patients who were Asian (RR, 1.10), Black (RR, 1.05), or Hispanic (RR, 1.04). Undertriage became gradually less likely with each additional year in the study period, with an RR of 0.89 in 2019 and 2020.

Among the study’s limitations were use of ESI version 4, instead of the currently used 5, and the omission of common procedures from the outcome definition that “may systematically bias the analysis toward overtriage,” the editorial noted. The authors also did not include pain as a variable in the analysis, which can often indicate patient acuity.

Further, this study was unable to include covariates identified in other research that may influence clinical decision-making, such as “the presenting illness or injury, children with complex medical needs, and language proficiency,” Dr. Frankenberger and colleagues wrote. “Furthermore, environmental stressors, such as ED volume and crowding, can influence how a nurse prioritizes care and may increase bias in decision-making and/or increase practice variability.”

The study was funded by the Kaiser Permanente Northern California (KPNC) Community Health program. One author had consulting payments from CSL Behring and Abbott Point-of-Care, and six of the authors have received grant funding from the KPNC Community Health program. The editorial authors reported no conflicts of interest.